Search results for: mental disorder due to drug use

Authors: Jacob Bogart, Adaobi Egboka

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Nigeria signed and ratified the Convention on the Rights of Persons with Disabilities in 2010, which was heralded as a much-needed step towards protecting the rights of persons with disabilities (PWDs). However, even with such progress, incarcerated PWDs have been left behind. The current legal framework in Nigeria does not consider the particular challenges PWDs face in prison nor make provisions to address them, despite the need for such reforms. Indeed, given the closed and restricted nature of prisons, and the violence that results from overcrowding, lack of supervision, and poor facilities, prisoners with disabilities often face significant challenges while incarcerated. While every prisoner is affected by these issues, PWDs are disproportionately harmed by them due to the nature of their disability. A study of four prisons in Lagos State, Nigeria was carried out by interviewing prisoners with disabilities, prison officials, advocates, and academics. The study found that for prisoners with physical disabilities, inaccessible prison facilities and a lack of mobility, hearing, or seeing assistance can often cause them to be dependent on the mercy of the other inmates for assistance in performing such basic functions as using the restroom, going to church, or washing themselves. Prison officials do not assist these PWDs or provide them with aids, such as crutches or a cane. Relatedly, prisoners with psychosocial disabilities (mental health conditions) often are not removed to health care facilities, despite a law to that effect, and are left to languish in prisons without the mental health care treatment they need. This presentation argues that reforms addressing the rights of PWDs must consider and make provisions for prisoners with disabilities, such as ensuring that prison facilities are accessible, providing PWDs with mobility, seeing or hearing aids as needed, and conducting mental health screenings for persons awaiting trial immediately upon entering the prison. These reforms, among others, are necessary first steps toward realizing the rights of prisoners with disabilities in Nigeria.

Keywords: disability rights, human rights, Lagos, Nigeria, prisoners with disabilities

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Authors: Brigitta Bodnár, Lajos Kovács, Zoltán Kupihár

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The cancer cells require higher amount of nucleoside building blocks for their proliferation, therefore they have significantly higher uptake of nucleosides by the different nucleoside transporters. Therefore, the conjugation with nucleosides may significantly increase the efficiency and selectivity of potential active pharmaceutical ingredients. On the other hand, the advantage of using a nucleoside could be either the higher activity on targeted enzymes overrepresented in cancer cells or an enhanced cellular uptake of the bioconjugates in these cells compared to the healthy ones. This fact can be used to make the nucleosides, as targeting moieties covalently bound to anti-cancer drug molecules which can selectively accumulate in cancer cells. However, in order to form the nucleoside-drug conjugates, such nucleoside building blocks are needed, which can selectively be coupled to the drug molecules containing even a high number of diverse functional groups. One of the most selective conjugation techniques is the copper-catalyzed azide-alkyne click reaction that requires the presence of an alkyl group on one of the conjugated molecules and an azide group on the other. In case of nucleosides, the development of azide group is simpler for which the replacement of the 5'-hydroxy group is the most suitable. This transformation generally involves many side reactions and result in very low yields. In addition, during our experiments, the transformation of the 2'-deoxyguanosine to the corresponding 5'-deoxy-5’-azido-2’-deoxyguanosine could not be performed with any of the methods described in the literature. Therefore, we have tried to overcome these difficulties with not only using the traditional process based on the 2 step exchange of tosyl to azide, but also using the Mitsunobu reaction which requires only one step. However, this path proved to be unsuccessful in spite of the optimizing the reaction conditions. Finally, a method has been developed whereby the azide groups were incorporated into the 5’-position resulting in significantly better yields compared to all other previous methods, and we were able to produce all the four nucleoside derivatives.

Keywords: 5'-azidonucleosides, bioconjugate, click reaction, proliferation

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Authors: Kuo-Chun Chien, Chia-Hui Chang, Ren-Der Sun

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Legal Judgment Prediction (LJP) is a subtask for legal AI. Its main purpose is to use the facts of a case to predict the judgment result. In Taiwan's criminal procedure, when prosecutors complete the investigation of the case, they will decide whether to prosecute the suspect and which article of criminal law should be used based on the facts and evidence of the case. In this study, we collected 305,240 indictments from the public inquiry system of the procuratorate of the Ministry of Justice, which included 169 charges and 317 articles from 21 laws. We take the crime facts in the indictments as the main input to jointly learn the prediction model for law source, article, and charge simultaneously based on the pre-trained Bert model. For single article cases where the frequency of the charge and article are greater than 50, the prediction performance of law sources, articles, and charges reach 97.66, 92.22, and 60.52 macro-f1, respectively. To understand the big performance gap between articles and charges, we used a bipartite graph to visualize the relationship between the articles and charges, and found that the reason for the poor prediction performance was actually due to the wording precision. Some charges use the simplest words, while others may include the perpetrator or the result to make the charges more specific. For example, Article 284 of the Criminal Law may be indicted as “negligent injury”, "negligent death”, "business injury", "driving business injury", or "non-driving business injury". As another example, Article 10 of the Drug Hazard Control Regulations can be charged as “Drug Control Regulations” or “Drug Hazard Control Regulations”. In order to solve the above problems and more accurately predict the article and charge, we plan to include the article content or charge names in the input, and use the sentence-pair classification method for question-answer problems in the BERT model to improve the performance. We will also consider a sequence-to-sequence approach to charge prediction.

Keywords: legal judgment prediction, deep learning, natural language processing, BERT, data visualization

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Authors: C. Peeper McDonald

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Despite the multiracial population growing exponentially in the world and especially in the U.S., there continues to be a lack of culturally responsive research addressing the unique experiences and needs of this population, especially within counseling and counselor education settings. It is evident that their unique racial microaggressive experiences need to be better understood within the field of professional counseling to not only underscore competent training and practice but also culturally responsive training and practice. The participants of this study were 13 (n=13) individuals from the United States who identified as multiracial and said they had a microaggressive experience with either their counselor or counseling professor. Data were gathered through one-on-one, semi-structured interviews. The analysis employed phenomenological methods based on the transcendental approach, resulting in themes that encapsulated the core of the participants' experiences, including multiracial microaggressions that are derogatory and perpetuate privilege/oppression; counselors and their training programs should embody safety, support, attentiveness, inter-personal sensitivity, and awareness of the impact on others; microaggressions negatively affect the counseling relationship and outcomes; awareness surrounding the emotional impact of microaggressions; strength-based responses and future responses to microaggressions; and advocacy and suggestions for counselors and counselor educators. These themes are discussed in detail, and recommendations for researchers, counselor educators, and professional counselors to improve training and practice are provided. This U.S. study's insights into the Multiracial experience of microaggressions within the mental health profession can inform global mental health practices by highlighting the need for culturally responsive counseling that recognizes and addresses racial nuances. Such knowledge is transferable to international settings where multiracial populations may also encounter similar challenges, aiding in the development of global standards for culturally competent counseling practices.

Keywords: culturally responsive training and practice, mental health, microaggressions, multiracial

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Authors: Hoda Dehghani, Zahra Dehghani

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Considering the obvious growth and variety of veterinary biological product and increase consumption and also the price, it is necessary to establish the rules and serious monitoring of this products which are less expensive than the original products. The scope of this research is the study of comparing the registration criteria and procedures of veterinary biological drugs in the world's leading agencies such as EMA, FDA, and WHO. For this, purpose the rules and regulations for registration of these drugs in prestigious organizations such as the FDA, EMA and WHO were examined and compared with the existing legislation in Iran. Studies show that EMA is the forefront of the compilation and registration of drugs in the world. China is a one of the greatest country in the development of drugs and establishes very closely guidelines with creditable global guidelines, and Now, is the first country to implement the rules codified in the Far East and followed by china, India and, South Korea and Taiwan have taken incorporate the industry's top ranking in Asia. At now, Asia by creating appropriate indicators not only as a powerful center in the field of drug delivery but also as a competitor to the United States is a major source of drug discovery and creation of innovation. the activities such as clinical trials and pharmaceutical investment is the speed of technology on the continent.

Keywords: veterinary biological product, regulation of registration, biological products, regularity authorities

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Authors: K. Srujana, Vinay U. Rao, M. Sudhakar

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Isoniazide (INH) a freely water soluble and pyrazinamide (Z) a practically water insoluble first line anti tubercular (TB) drugs were identified as candidates for optimizing the Moisture Activated Dry Granulation (MADG) process. The work focuses on identifying the effect of binder type and concentration as well as the effect of magnesium stearate level on critical quality attributes of Disintegration time (DT) and in vitro dissolution test when the tablets are processed by the MADG process. Also, the level of the drug concentration, binder concentration and fluid addition during the agglomeration stage of the MADG process was evaluated and optimized. For INH, it was identified that for tablets with HPMC as binder at both 2% w/w and 5% w/w level and Magnesium stearate upto 1%w/w as lubrication the DT is within 1 minute and the dissolution rate is the fastest (> 80% in 15 minutes) as compared to when PVP or pregelatinized starch is used as binder. Regarding the process, fast disintegrating and rapidly dissolving tablets are obtained when the level of drug, binder and fluid uptake in agglomeration stage is 25% w/w 0% w/w binder and 0.033%. w/w. At the other 2 levels of these three ingredients, the DT is significantly impacted and dissolution is also slower. For pyrazinamide,it was identified that for the tablets with 2% w/w level of each of PVP as binder and Cross Caramellose Sodium disintegrant the DT is within 2 minutes and the dissolution rate is the fastest(>80 in 15 minutes)as compared to when HPMC or pregelatinized starch is used as binder. This may be attributed to the fact that PVP may be acting as a solubilizer for the practically insoluble Pyrazinamide. Regarding the process,fast dispersing and rapidly disintegrating tablets are obtained when the level of drug, binder and fluid uptake in agglomeration stage is 10% w/w,25% w/w binder and 1% w/w.At the other 2 levels of these three ingredients, the DT is significantly impacted and dissolution is comparatively slower and less complete.

Keywords: agglomeration stage, isoniazide, MADG, moisture distribution stage, pyrazinamide

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Authors: Satya Eswari Jujjavarapu, Swasti Dhagat, Lata Upadhyay, Reecha Sahu

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Silver nanoparticles have a broad range of antimicrobial and antifungal properties ranging from soaps, pastes to sterilization and drug delivery systems. These can be synthesized by physical, chemical and biological methods; biological methods being the most popular owing to their non-toxic nature and reduced energy requirements. Microbial surfactants, produced on the microbial cell surface or excreted extracellularly are an alternative to synthetic surfactants for the production of silver nanoparticles. Hence, they are also called as green molecules. Microbial lipopeptide surfactants (biosurfactant) exhibit anti-tumor and anti-microbial properties and can be used as drug delivery agents. In this study, biosurfactant was synthesized by using a strain of acillus subtilis. The biosurfactant thus produced was analysed by emulsification assay, oil spilling test, and haemolytic test. Biosurfactant-mediated silver nanoparticles were synthesised by microwave irradiation of the culture supernatant and further characterized by UV–vis spectroscopy for a range of 400-600 nm. The UV–vis spectra showed a surface plasmon resonance vibration band at 410 nm corresponding to the peak of silver nanoparticles.

Keywords: biosurfactant, Bacillus subtilis, silver nano particle, lipopeptide

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Authors: A. Julio, R. Caparica, S. Costa Lima, S. Reis, J. G. Costa, P. Fonte, T. Santos De Almeida

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The Mycobacterium leprae causes a chronic and infectious disease called leprosy, which the most common symptoms are peripheral neuropathy and deformation of several parts of the body. The pharmacological treatment of leprosy is a combined therapy with three different drugs, rifampicin, clofazimine, and dapsone. However, clofazimine and dapsone have poor solubility in water and also low bioavailability. Thus, it is crucial to develop strategies to overcome such drawbacks. The use of ionic liquids (ILs) may be a strategy to overcome the low solubility since they have been used as solubility promoters. ILs are salts, liquid below 100 ºC or even at room temperature, that may be placed in water, oils or hydroalcoholic solutions. Another approach may be the encapsulation of drugs into polymeric nanoparticles, which improves their bioavailability. In this study, two different classes of ILs were used, the imidazole- and the choline-based ionic liquids, as solubility enhancers of the poorly soluble antileprotic drugs. Thus, after the solubility studies, it was developed IL-PLGA nanoparticles hybrid systems to deliver such drugs. First of all, the solubility studies of clofazimine and dapsone were performed in water and in water: IL mixtures, at ILs concentrations where cell viability is maintained, at room temperature for 72 hours. For both drugs, it was observed an improvement on the drug solubility and [Cho][Phe] showed to be the best solubility enhancer, especially for clofazimine, where it was observed a 10-fold improvement. Later, it was produced nanoparticles, with a polymeric matrix of poly(lactic-co-glycolic acid) (PLGA) 75:25, by a modified solvent-evaporation W/O/W double emulsion technique in the presence of [Cho][Phe]. Thus, the inner phase was an aqueous solution of 0.2 % (v/v) of the above IL with each drug to its maximum solubility determined on the previous study. After the production, the nanosystem hybrid was physicochemically characterized. The produced nanoparticles had a diameter of around 580 nm and 640 nm, for clofazimine and dapsone, respectively. Regarding the polydispersity index, it was in agreement of the recommended value of this parameter for drug delivery systems (around 0.3). The association efficiency (AE) of the developed hybrid nanosystems demonstrated promising AE values for both drugs, given their low solubility (64.0 ± 4.0 % for clofazimine and 58.6 ± 10.0 % for dapsone), that prospects the capacity of these delivery systems to enhance the bioavailability and loading of clofazimine and dapsone. Overall, the study achievement may signify an upgrading of the patient’s quality of life, since it may mean a change in the therapeutic scheme, not requiring doses of drug so high to obtain a therapeutic effect. The authors would like to thank Fundação para a Ciência e a Tecnologia, Portugal (FCT/MCTES (PIDDAC), UID/DTP/04567/2016-CBIOS/PRUID/BI2/2018).

Keywords: ionic liquids, ionic liquids-PLGA nanoparticles hybrid systems, leprosy treatment, solubility

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Authors: Alaaeddeen M. Seufi

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Many have been published on therapeutic derivatives from living organisms including insects. In addition to traditional maggot therapy, more than 900 therapeutic products were isolated from insects. Most people look at insects as enemies and others believe that insects are friends. Many beneficial insects rather than Honey Bees, Silk Worms and Shellac insect could insure human-insect friendship. In addition, insects could be MicroFactories, Biosensors or Bioreactors. InsectFarm is an amazing example of the applied research that transfers insects from laboratory to market by Prof Mircea Ciuhrii and co-workers. They worked for 18 years to derive therapeutics from insects. Their research resulted in production of more than 30 commercial medications derived from insects (e.g. Imunomax, Noblesse, etc.). Two general approaches were followed to discover drugs from living organisms. Some laboratories preferred biochemical approach to purify components of the innate immune system of insects and insect metabolites as well. Then the purified components could be tested for many therapeutic trials. Other researchers preferred molecular approach based on proteomic studies. Components of the innate immune system of insects were then tested for their medical activities. Our Laboratory team preferred to induce insect immune system (using oral, topical and injection routes of administration), then a transcriptomic study was done to discover the induced genes and to identify specific biomarkers that can help in drug discovery. Biomarkers play an important role in medicine and in drug discovery and development as well. Optimum biomarker development and application will require a team approach because of the multifaceted nature of biomarker selection, validation, and application. This team uses several techniques such as pharmacoepidemiology, pharmacogenomics, and functional proteomics; bioanalytical development and validation; modeling and simulation to improve and refine drug development. Our Achievements included the discovery of four components of the innate immune system of Spodoptera littoralis and Musca domestica. These components were designated as SpliDef (defesin), SpliLec (lectin), SpliCec (cecropin) and MdAtt (attacin). SpliDef, SpliLec and MdAtt were confirmed as antimicrobial peptides, while SpliCec was additionally confirmed as anticancer peptide. Our current research is going on to achieve something in antioxidants and anticoagulants from insects. Our perspective is to achieve something in the mass production of prototypes of our products and to reach it to the commercial level. These achievements are the integrated contributions of everybody in our team staff.

Keywords: AMPs, insect, innate immunitty, therappeutics

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Authors: Md. Fazlul Karim, Ashik Sharfaraz, Aysha Ferdoushi

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Background: Computational medicinal chemistry approaches are used for designing and identifying new drug-like molecules, predicting properties and pharmacological activities, and optimizing lead compounds in drug development. SIRT7, a nicotinamide adenine dinucleotide (NAD+)-dependent deacylase which regulates aging, is an emerging target for cancer therapy with mounting evidence that SIRT7 downregulation plays important roles in reversing cancer phenotypes and suppressing tumor growth. Activation or altered expression of SIRT7 is associated with the progression and invasion of various cancers, including liver, breast, gastric, prostate, and non-small cell lung cancer. Objectives: The goal of this work was to identify potent and selective bioactive candidate inhibitors of SIRT7 by in silico screening of small molecule compounds obtained from Nigella sativa (N. sativa). Methods: SIRT7 structure was retrieved from The Research Collaboratory for Structural Bioinformatics Protein Data Bank (RCSB PDB), and its active site was identified using CASTp and metaPocket. Molecular docking simulation was performed with PyRx 0.8 virtual screening software. Drug-likeness properties were tested using SwissADME and pkCSM. In silico toxicity was evaluated by Osiris Property Explorer. Bioactivity was predicted by Molinspiration software. Antitumor activity was screened for Prediction of Activity Spectra for Substances (PASS) using Way2Drug web server. Molecular dynamics (MD) simulation was carried out by Desmond v3.6 package. Results: A total of 159 bioactive compounds from the N. Sativa were screened against the SIRT7 enzyme. Five bioactive compounds: chrysin (CID:5281607), pinocembrin (CID:68071), nigellidine (CID:136828302), nigellicine (CID:11402337), and epicatechin (CID:72276) were identified as potent SIRT7 anti-cancer candidates after docking score evaluation and applying Lipinski's Rule of Five. Finally, MD simulation identified Chrysin as the top SIRT7 anti-cancer candidate molecule. Conclusion: Chrysin, which shows a potential inhibitory effect against SIRT7, can act as a possible anti-cancer drug candidate. This inhibitor warrants further evaluation to check its pharmacokinetics and pharmacodynamics properties both in vitro and in vivo.

Keywords: SIRT7, antitumor, molecular docking, molecular dynamics simulation

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Authors: Leticia Souza Guirra, Márcia Eduarda Vieira Ramos, Edlaine Souza Pereira, Leticia Correa Celeste

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Introduction: Studies indicate that equine-assisted therapy enables improvements in several areas of functioning that are impaired in children with autism spectrum disorder (ASD), such as social interaction and communication. Objective: The study proposes to analyze the development of dialogic skills of a verbal child with ASD after participating in the equine-assisted therapy Step By Step in Communication. Method: This is quantitative and qualitative research through a case study. It refers to a 6 years old child diagnosed with ASD belonging to a group of practitioners of the Brazilian National Equine-Assited-Therapy Association. The Behavioral Observation Protocol (PROC) was used to evaluate communicative skills before and after the intervention, which consisted of 24 sessions once a week. Results: All conversational skills increased their frequency, with participation in dialogue and initiation of interaction. The child also increases the habit of waiting for his turn and answering the interlocutor. The emission of topics not related to conversation and echolalia showed a significant decrease after the intervention. Conclusion: The studied child showed improvement in communicative skills after participating in the equine-assisted therapy Step By Step in Communication. Contributions: This study contributes to a greater understanding of the impact of equine-assisted therapy on the communicative abilities of children with ASD.

Keywords: equine-assisted-therapy, autism spectrum disorder, language, communication, language and hearing sciences

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Authors: Judy M. Obliosca, Olivia Vest, Sandra Poulos, Kelsi Smith, Tammy Ferguson, Abigail Powers Lott, Alicia K. Smith, Yang Xu, Christopher K. Tison

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Post-Traumatic Stress Disorder (PTSD) is a mental health problem that people may develop after experiencing traumatic events such as combat, natural disasters, and major emotional challenges. Tragically, the number of military personnel with PTSD correlates directly with the number of veterans who attempt suicide, with the highest rate in the Army. Research has shown epigenetic risks in those who are prone to several psychiatric dysfunctions, particularly PTSD. Once initiated in response to trauma, epigenetic alterations in particular, the DNA methylation in the form of 5-methylcytosine (5mC) alters chromatin structure and represses gene expression. Current methods to detect DNA methylation, such as bisulfite-based genomic sequencing techniques, are laborious and have massive analysis workflow while still having high error rates. A faster and simpler detection method of high sensitivity and precision would be useful in a clinical setting to confirm potential PTSD etiologies, prevent other psychiatric disorders, and improve military health. A nano-enhanced Surface Plasmon Resonance imaging (SPRi)-based assay that simultaneously detects site-specific 5mC base (termed as PTSD base) in methylated genes related to PTSD is being developed. The arrays on a sensing chip were first constructed for parallel detection of PTSD bases using synthetic and genomic DNA (gDNA) samples. For the gDNA sample extracted from the whole blood of a PTSD patient, the sample was first digested using specific restriction enzymes, and fragments were denatured to obtain single-stranded methylated target genes (ssDNA). The resulting mixture of ssDNA was then injected into the assay platform, where targets were captured by specific DNA aptamer probes previously immobilized on the surface of a sensing chip. The PTSD bases in targets were detected by anti-5-methylcytosine antibody (anti-5mC), and the resulting signals were then enhanced by the universal nanoenhancer. Preliminary results showed successful detection of a PTSD base in a gDNA sample. Brighter spot images and higher delta values (control-subtracted reflectivity signal) relative to those of the control were observed. We also implemented the in-house surface activation system for detection and developed SPRi disposable chips. Multiplexed PTSD base detection of target methylated genes in blood DNA from PTSD patients of severity conditions (asymptomatic and severe) was conducted. This diagnostic capability being developed is a platform technology, and upon successful implementation for PTSD, it could be reconfigured for the study of a wide variety of neurological disorders such as traumatic brain injury, Alzheimer’s disease, schizophrenia, and Huntington's disease and can be extended to the analyses of other sample matrices such as urine and saliva.

Keywords: epigenetic assay, DNA methylation, PTSD, whole blood, multiplexing

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Authors: Arunava Chakrabarti

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A one-dimensional chain of magnetic atoms, representative of a quantum gas in an artificial quasi-periodic potential and modeled by the well-known Aubry-Andre function and its variants are studied in respect of its capability of working as a spin filter for arbitrary spins. The basic formulation is explained in terms of a perfectly periodic chain first, where it is shown that a definite correlation between the spin S of the incoming particles and the magnetic moment h of the substrate atoms can open up a gap in the energy spectrum. This is crucial for a spin filtering action. The simple one-dimensional chain is shown to be equivalent to a 2S+1 strand ladder network. This equivalence is exploited to work out the condition for the opening of gaps. The formulation is then applied for a one-dimensional chain with quasi-periodic variation in the site potentials, the magnetic moments and their orientations following an Aubry-Andre modulation and its variants. In addition, we show that a certain correlation between the system parameters can generate absolutely continuous bands in such systems populated by Bloch like extended wave functions only, signaling the possibility of a metal-insulator transition. This is a case of correlated disorder (a deterministic one), and the results provide a non-trivial variation to the famous Anderson localization problem. We have worked within a tight binding formalism and have presented explicit results for the spin half, spin one, three halves and spin five half particles incident on the magnetic chain to explain our scheme and the central results.

Keywords: Aubry-Andre model, correlated disorder, localization, spin filter

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Authors: Riksa Parikrama, Bremmy Laksono, Dadang S. H. Effendi

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Disorder of sexual development (DSD) covers various conditions with a specific term such as Klinefelter syndrome, Turner syndrome, androgen insensitivity syndrome, and many more. The techniques to accurately diagnose those conditions has developed extensively. However, conventional karyotype and fluorescence in situ hybridization (FISH) are still widely used in many genetic laboratories as the basic method to determine chromosomal condition of DSD patients. Cytogenetic study was conducted on 36 DSD patients in Cell Culture and Cytogenetics Laboratory, Faculty of Medicine Universitas Padjadjaran, Indonesia. Most of the patients referred to the laboratory diagnosed with primary amenorrhea, hypospadias, micropenis, genitalia ambiguity, or congenital adrenal hyperplasia. The study used G-banding technique to acquire complete karyotype and followed by FISH as either confirmation or comparison method. Among 36 patients, G-banding karyotype and FISH results showed that two were diagnosed with 45, X (Turner syndrome); three with 47, XXY (Klinefelter syndrome); five with 46, XX DSD; 22 with 46, XY DSD; and four with 46,XY complete androgen insensitivity syndrome. G-banding karyotype analysis were paired with FISH using X and Y chromosome probe produced similar results. The present analysis showed that FISH is a reliable method to attain a rapid and accurate chromosome analysis result of DSD patients. Nevertheless, conventional karyotype technique is still vital if other condition appeared in DSD patients in order to get more detailed karyotype result which FISH method cannot achieve.

Keywords: chromosome, DSD, FISH, karyotype

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Authors: Bylhah Mugotitsa, Jim Todd, Agnes Kiragga, Jay Greenfield, Evans Omondi, Lukoye Atwoli, Reinpeter Momanyi

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The INSPIRE network aims to build an open, ethical, sustainable, and FAIR (Findable, Accessible, Interoperable, Reusable) data science platform, particularly for longitudinal mental health (MH) data. While studies have been done at the clinical and population level, there still exists limitations in data and research in LMICs, which pose a risk of underrepresentation of mental disorders. It is vital to examine the existing longitudinal MH data, focusing on how FAIR datasets are. This landscape analysis aimed to provide both overall level of evidence of availability of longitudinal datasets and degree of consistency in longitudinal studies conducted. Utilizing prompters proved instrumental in streamlining the analysis process, facilitating access, crafting code snippets, categorization, and analysis of extensive data repositories related to depression, anxiety, and psychosis in Africa. While leveraging artificial intelligence (AI), we filtered through over 18,000 scientific papers spanning from 1970 to 2023. This AI-driven approach enabled the identification of 228 longitudinal research papers meeting inclusion criteria. Quality assurance revealed 10% incorrectly identified articles and 2 duplicates, underscoring the prevalence of longitudinal MH research in South Africa, focusing on depression. From the analysis, evaluating data and metadata adherence to FAIR principles remains crucial for enhancing accessibility and quality of MH research in Africa. While AI has the potential to enhance research processes, challenges such as privacy concerns and data security risks must be addressed. Ethical and equity considerations in data sharing and reuse are also vital. There’s need for collaborative efforts across disciplinary and national boundaries to improve the Findability and Accessibility of data. Current efforts should also focus on creating integrated data resources and tools to improve Interoperability and Reusability of MH data. Practical steps for researchers include careful study planning, data preservation, machine-actionable metadata, and promoting data reuse to advance science and improve equity. Metrics and recognition should be established to incentivize adherence to FAIR principles in MH research

Keywords: longitudinal mental health research, data sharing, fair data principles, Africa, landscape analysis

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Authors: Mohamed Wahba

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Objective: To build a comparative arm for product (X) in specific gene mutated advanced gastrointestinal cancer using real world evidence to fulfill HTA requirements in drug evaluation. Methods: Data for product (X) were collected from phase II clinical trial while real world data for (Y) and (Z) were collected from US database. Real-world (RW) cohorts were matched to clinical trial base line characteristics using weighting by odds method. Outcomes included progression-free survival (PFS) and overall survival (OS) rates. Study location and participants: Internationally (product X, n=80) and from USA (Product Y and Z, n=73) Results: Two comparisons were made: trial cohort 1 (X) versus real-world cohort 1 (Z), trial cohort 2 (X) versus real-world cohort 2 (Y). For first line, the median OS was 9.7 months (95% CI 8.6- 11.5) and the median PFS was 5.2 months (95% CI 4.7- not reached) for real-world cohort 1. For second line, the median OS was 10.6 months (95% CI 4.7- 27.3) for real-world cohort 2 and the median PFS was 5.0 months (95% CI 2.1- 29.3). For OS analysis, results were statistically significant but not for PFS analysis. Conclusion: This study provided the clinical comparative outcomes needed for HTA evaluation.

Keywords: real world evidence, pharmacoeconomics, HTA agencies, oncology

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Authors: Vijay R. Patil, Sathiyanarayanan Lohidasan, K. R. Mahadik

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Gastrointestinal stability of andrographolide was evaluated in vitro in simulated gastric (SGF) and intestinal (SIF) fluids using a validated HPLC-PDA method. The method was validated using a 5μm ThermoHypersil GOLD C18column (250 mm × 4.0 mm) and mobile phase consisting of water: acetonitrile; 70: 30 (v/v) delivered isocratically at a flow rate of 1 mL/min with UV detection at 228 nm. Andrographolide in pure form and extract Andrographis paniculata was incubated at 37°C in an incubator shaker in USP simulated gastric and intestinal fluids with and without enzymes. Systematic protocol as per FDA Guidance System was followed for stability study and samples were assayed at 0, 15, 30 and 60 min intervals for gastric and at 0, 15, 30, 60 min, 1, 2 and 3 h for intestinal stability study. Also, the stability study was performed up to 24 h to see the degradation pattern in SGF and SIF (with enzyme and without enzyme). The developed method was found to be accurate, precise and robust. Andrographolide was found to be stable in SGF (pH ∼ 1.2) for 1h and SIF (pH 6.8) up to 3 h. The relative difference (RD) of amount of drug added and found at all time points was found to be < 3%. The present study suggests that drug loss in the gastrointestinal tract takes place may be by membrane permeation rather than a degradation process.

Keywords: andrographolide, Andrographis paniculata, in vitro, stability, gastric, Intestinal HPLC-PDA

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Authors: Zaka Nisa, Farooq Sher

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Adverse drug reactions (ADRs) underreporting is a great challenge to Pharmacovigilance. Health care professionals have to consider ADR reporting as their professional obligation, an effective system of ADR reporting is important to improve patient health care and safety. The present study is designed to assess the knowledge, attitude, practice and factors associated with ADR reporting by health care professionals (physicians and pharmacists) in public and private hospitals of Pakistan. A pretested questionnaire was administered to 384 physicians and pharmacists in public and private hospitals. Respondents were evaluated for their knowledge, attitude, and practice related to ADR reporting. The data was analyzed using the SPSS statistical software, the factors which encourage and discourage respondents in reporting ADRs were determined. Most of the respondents have shown a positive attitude towards ADR reporting. The response rate was 95.32%. Of the 367 questionnaires, including 333 (86.5%) physicians and 34 (8.8%) pharmacists with the mean age 28.34 (SD= 6.69), most of the respondents showed poor ADR reporting knowledge (83.1%). The majority of respondents (78.2%) showed positive attitude towards ADR reporting and only (12.3%) hospitals have good ADR reporting practice. Knowledge of respondents in public hospitals (8.6%) was less as compare to those in the private hospitals (29.7%) (P < 0.001). Attitude of respondents in private hospitals was more positive (92.4%) than those in public hospitals (68.8%) (P < 0.001). No significant difference was observed in practicing of ADR reporting in public (11.8%) and private hospitals (13.1%) (P value 0.89). Seriousness of ADR, unusualness of reaction, new drug involvement and confidence in diagnosis of ADR were the factors which encourage respondents to report ADR, however, lack of knowledge regarding where and how to report ADR, lack of access to ADR reporting form, managing patients was more important than reporting ADR, legal liability issues were the factors which discourage respondents to report ADR. The study reveals poor knowledge and practice regarding ADR reporting. However positive attitude was seen regarding ADR reporting. There is a need of educational training for health care professionals as well as genuine and continuous efforts are required by Government and health authorities to ensure the proper implementation of ADR reporting system in all of the hospitals.

Keywords: adverse drugs reactions (ADR), pharmacovigilance, spontaneous ADR reporting, knowledge of ADR, attitude of health care profesionals, practice of ADR reporting

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Authors: Tanya Anand, Arun Kandasamy, L. N. Suman

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Family based therapy for adolescent substance abuse has been studied to be effective in the West. Whereas, based on literature review, family therapy and interventions for adolescent substance abuse is still in its nascent stages in India. A multidimensional perspective to treatment has been indicated consistently in the Indian literature, but standardized therapy which addresses early substance abuse, from a social-ecological perspective has not been developed and studied for Indian population. While numerous researches have been conducted in India on the need of engaging the family in therapy for the purpose of symptom reduction, long-term maintenance of gains, and reducing family burnout, distress and dysfunction; a family based model in the Indian context has not been developed and tried, to the best of our knowledge. Hence, from the aim of building a model to treat adolescent substance abuse within the family context, experts in the area of mental health and deaddiction were interviewed to inform upon the clinical difficulties, challenges, uniqueness that Indian families present with. The integration of indigenous techniques that would be helpful in engaging families of young individuals with difficulties were also explored. Eight experts' who were interviewed, have 10-30 years of experience in working with families and substance users. An open-ended interview was conducted with the experts individually and audio-recorded. The interviews were then transcribed and subjected to qualitative analysis for building a framework and treatment guideline. Additionally, interviews with patients and their parents were conducted to elicit ‘felt needs’. The results of the analysis revealed culture-specific issues widely experienced within Indian families by adolescents and young adults, centering around the theme of Individuation versus collective identity and living. Substance abuse, in this framework, was found to be perceived as one of the maladaptive ways of the youth to disengage from the family and attempt at individuation and the responsibilities that are considered entitlements in the culture. On the other hand, interviews with family members revealed them to be engaging in inconsistent patterns of care and parenting. This was experienced and observed in terms of fostering interdependence within the family, sometimes within adverse socio-economic and societal conditions, where enacted and perceived stigma kept the individual and family members in a vicious loop of maladaptive coping patterns, dysfunctional family arrangements, and often leading to burnout with poor help seeking. The paper inform upon a framework that lays down the foundation for assessments, planning, case management and therapist competencies, required to address alcohol and drug issues in an Indian family context with such etiological factors at its heart. This paper will cover qualitative results of the interviews and present a model that may guide mental health professionals for treatment of adolescent substance use and family therapy.

Keywords: Indian families, family therapy, de-addiction, adolescent, youth, substance abuse, behavioral issues, felt needs, culture, etiology, model building, framework development, interviews

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Authors: Suzanne L. Stewart, Mikaela D. Gabriel

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Background: Indigenous People face multiple barriers to successful life transitions, including housing, employment, education, and health. Current statistical trends paint devastating life transitions for Indigenous Peoples, but colonization and its intergenerational impacts are typically lacking as the crucial context in which these trends occur. This presentation will illustrate the massive impact of colonization on Indigenous Peoples; its intergenerational transmission, and how it impacts Indigenous clients seeking mental health treatment today. Methods: A qualitative, narrative inquiry methodology was used to honour Indigenous storytelling and knowledge transmission. Indigenous Elders, outreach workers, and homeless clients were interviewed and narratively analyzed for in-depth trends and themes. Impact: This research provides a wealth of in-depth information as to the life transition needs of Indigenous clients, identify the systemic impacts of colonization to the health and wellbeing of Indigenous People, and strategies for mental health treatment.

Keywords: indigenous trauma, indigenous peoples of canada, intergenerational trauma, colonial trauma and treatment

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Authors: Mariia A. Parfenenko, Ilya S. Dantsev, Sergei V. Bochenkov, Natalia V. Vinogradova, Olga S. Groznova, Victoria Yu. Voinova

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Introduction: Autism is the most common neurodevelopmental disorder. Autism is characterized by difficulties in social interaction and adherence to stereotypic behavioral patterns and frequently co-occurs with epilepsy, intellectual disabilities, connective tissue disorders, and other conditions. CHD8 codes for chromodomain-helicase-DNA-binding protein 8 - a chromatin remodeler that regulates cellular proliferation and neurodevelopment in embryogenesis. CHD8 is one of the genes most frequently involved in autism. Patients and methods: 2 unrelated male patients, P3 and P12, aged 3 and 12 years old, underwent whole genome sequencing, which determined that they both had different likely pathogenic variants, both previously undescribed in literature. Sanger sequencing later determined that P12 inherited the variant from his affected mother. Results: P3 and P12 presented with autism, a developmental delay, ataxia, sleep disorders, overgrowth, and macrocephaly, as well as other clinical features typically present in patients with causative variants in CHD8. The mother of P12 also has autistic traits, as well as ataxia, hypotonia, sleep disorders, and other symptoms. However, P3 and P12 also have different cardiac abnormalities. P3 had signs of a repolarization disorder: a flattened T wave in the III and aVF derivations and a negative T wave in the V1-V2 derivations. He also had structural valve anomalies with associated regurgitation, local contractility impairment of the left ventricular, and diastolic dysfunction of the right ventricle. Meanwhile, P12 had Wolff-Parkinson-White syndrome and underwent radiofrequency ablation at the age of 2 years. At the time of observation, P12 had mild sinus arrhythmia and an incomplete right bundle branch block, as well as arterial hypertension. Discussion: Cardiac abnormalities were not previously reported in patients with causative variants in CHD8. The underlying mechanism for the formation of those abnormalities is currently unknown. However, the two hypotheses are either a disordered interaction with CHD7 – another chromodomain remodeler known to be directly involved in the cardiophenotype of CHARGE syndrome – a rare condition characterized by coloboma, heart defects and growth abnormalities, or the disrupted functioning of CHD8 as an A-Kinase Anchoring Protein, which are known to modulate cardiac function. Conclusion: We observed 2 unrelated autistic males with likely pathogenic variants in CHD8 that presented with typical symptoms of CHD8-related neurodevelopmental disorder, as well as cardiac abnormalities. Cardiac abnormalities have, until now, been considered uncharacteristic for patients with causative variants in CHD8. Further accumulation of data, including experimental evidence of the involvement of CHD8 in heart formation, will elucidate the mechanism underlying the cardiophenotype of those patients. Acknowledgements: Molecular genetic testing of the patients was made possible by the Charity Fund for medical and social genetic aid projects «Life Genome.»

Keywords: autism spectrum disorders, chromodomain-helicase-DNA-binding protein 8, neurodevelopmental disorder, cardio phenotype

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Authors: Jiwan P. Lavande, A. V. Chandewar

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In the present study, orodispersible tablets of diphenhydramine hydrochloride were prepared using croscarmellose sodium, crospovidone and camphor, menthol (as subliming agents) in different ratios and ODTs prepared with superdisintegrants were compared with ODTs prepared with camphor and menthol (subliming agents) for the following evaluation of in vitro disintegration time, dispersion time, wetting time, hardness and water absorption ratio. Results revealed that the tablets of all formulations have acceptable physical parameters. The drug and excipients compatibility study was evaluated using FTIR technique and has not detected any incompatibility. The in vitro release of drug from DC6 formulation was quick when compared to other formulations. Stability study was carried out as per ICH guidelines for three months and results revealed that upon storage disintegration time of tablets had not shown any significant difference. Microscopic study of different formulations of sublimed tablets showed formation of pores for the tablets prepared by sublimation method. Thus, conclusion can be made that the stable orodispersible tablets of diphenhydramine hydrochloride can be developed for the rapid release of diphenhydramine hydrochloride.

Keywords: orodispersible tablet, subliming agent, super disintegrants, diphenhydramine hydrochloride

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Authors: Anum Obaid, Iman Fatima, Wanisha Feroz, Haleema Imran, Hammad Tariq

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Unmarried women over thirty years of age as a health issue is a relatively young phenomenon, but it is rapidly growing in Pakistan; therefore, it is a public health issue. The challenges affecting nutrition and public health are some of the indispensable components that need to be met to achieve sustainable development goals (SDGs). This research intends to explain these goals in the context of nutrition and public health, especially analyzing the issues related to unmarried women above the age of thirty in Faisalabad, Pakistan. Still, this research is not feasible in Pakistan. In Pakistan alone, 10 million women over the age of 35 are unmarried, based on a recent United Nations report. The United Nations, in cooperation with the World Health Organization, has identified health as a state of being healthy, free from illness or disease, and not just a condition where there are no diseases or bodily disabilities. The current generation of women is unmarried and living a life under constant pressure from society to deliver changes like the diet these women take, and hence, their nutritional status defines their comprehensive health triangle, a mix of physical, mental, and social well-being. The research was carried out under the qualitative research paradigm, specifically through interviews with the participants who were unmarried women and married women above the age of thirty. This qualitative study explores how marriage affects the intake of nutrients, nutritional health, psychological and social well-being and their effects. The realization of well-being consisted of factors like physical health, mental and emotional health, pressure from society, social health, economic independence, and decision-making power to reveal the impact of singleness on well-being. The findings disclosed that marital status had a notable impact on the diet habits and nutritional behaviors of women in Faisalabad. Also, it was found that single women suffer from more stress and are not as positive as married women because they are lonely, as their husbands are absent from their lives. The findings established that nutritional understanding is differentially affected by marital status as a determinant of the health triangle consisting of physical, mental, and social health. Awareness of these factors is significant in designing specific goal-directed interventions that can enhance the nutritional well-being and general health status of unmarried women in Faisalabad. Hence, this study underscores the necessity of maintaining supportive environments and increasing the regard concerning the health state of single ladies beyond thirty.

Keywords: health triangle, over thirty, singleness, age barriers, unmarried women, women’s health, well-being

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Authors: Nadali Babaeian Jelodar, Chan Lai Keng, Arvind Bhatt, Laleh Bordbar, Leow E Shuen, Kamaruzaman Mohamed

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Recently artemisinin (the endoperoxide sesquiterpene lactone) has received considerable attention because of its antimalarial activity. It is isolated from the aerial part of the Artemisia annua L. Artemisinin is very difficult to synthesise also its production by mean of cell, tissue or organ cultures is very low. Presently, only its extraction from A. annua L. plants remains the only source of the drug. The reported yield of artemisinin from leaves of A. annua L. is very low and unstable, with yields typically less than 1% of leaf dry weight. To increase the percentage of artemisinin, researchers have been engaged in developing new varieties. A review concerning the breeding of A. annua L. is presented. The aim of this review is to bring together most of the available scientific research papers about the breeding conducted on the genus A. annua L., which is currently scattered across various publications. Through this review the authors hope to attract the attention of breeders throughout the world to focus on the unexplored potential of A. annua L. species. Also the future scope of this plant has been emphasized with a view of the importance of breeding of A. annua L. for increasing of artemisinin content. By releasing of new cultivar of A. annua L. and cultivation of this plant offers the opportunity to optimize yield and achieve a uniform, high quality product.

Keywords: Artemisia annua L., breeding, artemisinin, cultivation, medicinal plant

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Authors: Merav Ben Natan, Heba Igbarin, Arwa Watted

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Introduction: The rising prevalence of autism spectrum disorders (ASD) has heightened the need to understand the challenges faced by children with ASD and their families in emergency departments (EDs). Children with ASD often experience additional health issues and heightened anxiety in the chaotic ED environment, which can impact their care and parental satisfaction. Purpose: This study aimed to examine factors identified by mothers as affecting their satisfaction with the care provided to their children in the ED, among mothers of children with ASD in comparison to mothers of children without ASD. Design and methods: In this correlational quantitative study, 128 Israeli mothers – 59 (46%) mothers of children with ASD and 69 (54%) of children without ASD - completed an online survey based on a Ministry of Health national survey of patient experience. Results: Mothers of children with ASD expressed lower satisfaction with the care provided. The difference was particularly evident concerning waiting times for examination of the child by nurses and physicians in the ED, whether the nurses were attentive and responsive to the mother's questions and concerns, whether the ED staff demonstrated coordination and cooperation with regard to medical care of the child, and whether work in the ED was conducted in an orderly and organized manner. The presence of communication difficulties in children predicted mothers' satisfaction with care. Conclusions: These findings suggest that certain needs of mothers and/or their children with ASD do not receive an appropriate response in the ED. Practice implications: It is important to raise the awareness of healthcare providers in EDs regarding the needs of children with ASD and their parents, especially children with communication difficulties. Strategies should be implemented to improve the experience of children with ASD and their parents in the ED.

Keywords: autism spectrum disorder, emergency department, parental satisfaction, healthcare challenges

Procedia PDF Downloads 26

Authors: Piotr Muzyk, Beata Morawiec, Mariusz Opara, Andrzej Tomasik, Brygida Przywara-Chowaniec, Wojciech Jachec, Ewa Nowalany-Kozielska, Damian Kawecki

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Background: Coronary bifurcation is one of the most complex lesion in patients with coronary ar-tery disease. Provisional T-stenting is currently one of the recommended techniques. The aim was to assess optimal methods of treatment in the era of drug-eluting stents (DES). Methods: The regis-try consisted of data from 1916 patients treated with coronary percutaneous interventions (PCI) using either first- or second-generation DES. Patients with bifurcation lesion entered the analysis. Major adverse cardiac and cardiovascular events (MACCE) were assessed at one year of follow-up and comprised of death, acute myocardial infarction (AMI), repeated PCI (re-PCI) of target ves-sel and stroke. Results: Of 1916 registry patients, 204 patients (11%) were diagnosed with bifurcation lesion >50% and entered the analysis. The most commonly used technique was provi-sional T-stenting (141 patients, 69%). Optimization with kissing-balloons technique was performed in 45 patients (22%). In 59 patients (29%) second-generation DES was implanted, while in 112 pa-tients (55%), first-generation DES was used. In 33 patients (16%) both types of DES were used. The procedure success rate (TIMI 3 flow) was achieved in 98% of patients. In one-year follow-up, there were 39 MACCE (19%) (9 deaths, 17 AMI, 16 re-PCI and 5 strokes). Provisional T-stenting resulted in similar rate of MACCE to other techniques (16% vs. 5%, p=0.27) and similar occurrence of re-PCI (6% vs. 2%, p=0.78). The results of post-PCI kissing-balloon technique gave equal out-comes with 3% vs. 16% of MACCE in patients in whom no optimization technique was used (p=0.39). The type of implanted DES (second- vs. first-generation) had no influence on MACCE (4% vs 14%, respectively, p=0.12) and re-PCI (1.7% vs. 51% patients, respectively, p=0.28). Con-clusions: The treatment of bifurcation lesions with PCI represent high-risk procedures with high rate of MACCE. Stenting technique, optimization of PCI and the generation of implanted stent should be personalized for each case to balance risk of the procedure. In this setting, the operator experience might be the factor of better outcome, which should be further investigated.

Keywords: coronary bifurcation, drug eluting stents, long-term follow-up, percutaneous coronary interventions

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Authors: Katalin Gocze, Vanda A Nemes, Charlotte Briest

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Introduction: Premenstrual syndrome (PMS) is a psychoneuroendocrinological disorder adversely affecting life-quality for over 80% of hormonally active women. PMS has a negative impact on women’s daily life in terms of work, interpersonal relationships and leisure time activities. The aim of our study was to evaluate the effects of a yoga intervention focusing on the female pelvic area. Materials and methods: 34 women (ages 18-40) with PMS (Premenstrual Syndrome Screening Tool) and no previous experience in yoga were recruited and randomly assigned to either the yoga or the control group. The intervention consisted of 90’ yoga sessions twice a week and a daily 15’ self-practice module with carefully chosen yogic exercises addressing the reproductive organs by toning the pelvic floor and opening the hips as well as relieving stress and improving concentration. Severity of symptoms of PMS was assessed at the beginning and after the 8-week-long intervention. Pre- and post-program data collection included physical and psychological parameters and the evaluation of ACOQ PMS questionnaire and daily symptom diary. Results: Age and educational background were similar in the control and intervention group with an overall mean age of 29.11±4.78 years. PSST scores significantly improved in the yoga group (p=0.002), while difference in the control group’s pre and post-program values were non-significant (p=0.38). Perception and tolerance of anxiety and stress was significantly better after the intervention (p=0.008). As for changes in physical symptoms distinct improvement was registered for breast tenderness (p=0.028) and for meteorism (p=0.015). Discussion: Yoga’s success originates from the synergic positive effects of stress relief and regular physical activity. Benefits (both mental and physical) of strategically planned, focused yoga practice are apparent even after shorter time periods and can help women with PMS manage or eliminate symptoms in order to improve their life-quality.

Keywords: life-quality, physical symptoms, premenstrual syndrome, psychological impact, yoga

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Authors: Ferah Tesfaye Admasu

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Autism Spectrum Disorder (ASD) often presents significant communication challenges, particularly for non-verbal individuals who struggle to express their needs and emotions effectively. Assistive technologies (AT) have emerged as vital tools in enhancing communication abilities for this population. Recent advancements in artificial intelligence (AI) hold the potential to revolutionize the design and functionality of these technologies. This study explores the application of AI in developing intelligent, adaptive, and user-centered assistive technologies for non-verbal individuals with autism. Through a review of current AI-driven tools, including speech-generating devices, predictive text systems, and emotion-recognition software, this research investigates how AI can bridge communication gaps, improve engagement, and support independence. Machine learning algorithms, natural language processing (NLP), and facial recognition technologies are examined as core components in creating more personalized and responsive communication aids. The study also discusses the challenges and ethical considerations involved in deploying AI-based AT, such as data privacy and the risk of over-reliance on technology. Findings suggest that integrating AI into assistive technologies can significantly enhance the quality of life for non-verbal individuals with autism, providing them with greater opportunities for social interaction and participation in daily activities. However, continued research and development are needed to ensure these technologies are accessible, affordable, and culturally sensitive.

Keywords: artificial intelligence, autism spectrum disorder, non-verbal communication, assistive technology, machine learning

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Authors: Mont Kumpugdee-Vollrath, Khaled Abdallah

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Liposomes and pegylated liposomes were widely used as drug delivery system in pharmaceutical field since a long time. However, in the former time, polyethylene glycol (PEG) was connected into phospholipid after the liposomes were already prepared. In this paper, we intend to study the possibility of applying phospholipids which already connected with PEG and then they were used to prepare liposomes. The model drug resveratrol was used because it can be applied against different diseases. Cholesterol was applied to stabilize the membrane of liposomes. The thin film technique in a laboratory scale was a preparation method. The liposomes were then characterized by nanoparticle tracking analysis (NTA), photon correlation spectroscopy (PCS) and light microscopic techniques. The stable liposomes can be produced and the particle sizes after filtration were in nanometers. The 2- and 3-chains-PEG-phospholipid (PL) caused in smaller particle size than the 4-chains-PEG-PL. Liposomes from PL 90G and cholesterol were stable during storage at 8 °C of 56 days because the particle sizes measured by PCS were almost not changed. There was almost no leakage of resveratrol from liposomes PL 90G with cholesterol after diffusion test in dialysis tube for 28 days. All liposomes showed the sustained release during measuring time of 270 min. The maximum release amount of 16-20% was detected with liposomes from 2- and 3-chains-PEG-PL. The other liposomes gave max. release amount of resveratrol only of 10%. The release kinetic can be explained by Korsmeyer-Peppas equation. 

Keywords: liposome, NTA, resveratrol, pegylation, cholesterol

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Authors: Sam Yurdakul, Nick Baverstock, Jim Mills

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TDT 064 (FLEXISEQ®) is a drug-free gel used to treat osteoarthritis (OA)-associated pain and joint stiffness. It contains ultra-deformable phospholipid Sequessome™ vesicles, which can pass through the skin barrier intact. In six randomized OA studies, topical TDT 064 was well tolerated and improved joint pain, physical function and stiffness. In the largest study, these TDT 064-mediated effects were statistically significantly greater than oral placebo and equivalent to celecoxib. To understand the therapeutic effects of TDT 064, we investigated the localisation of the drug-free vesicles within rat synovial joints. TDT 064 containing DiO-labelled Sequessome™ vesicles was applied to the knees of four 6-week-old CD® hairless rats (10 mg/kg/ joint), 2–3 times/day, for 3 days (representing the recommended clinical dose). Eighteen hours later, the animals and one untreated control were sacrificed, and the knee joints isolated, flash frozen and embedded in Acrytol Mounting Media™. Approximately 15 sections (10 µm) from each joint were analysed by fluorescence microscopy. To investigate whether the localisation of DiO fluorescence was associated with intact vesicles, an anti-PEG monoclonal antibody (mAb) was used to detect Tween, a constituent of Sequessome™ vesicles. Sections were visualized at 484 nm (DiO) and 647 nm (anti-PEG mAb) and analysed using inForm 1.4 (Perkin Elmer, Inc.). Significant fluorescence was observed at 484 nm in sections from TDT 064-treated animals. No non-specific fluorescence was observed in control sections. Fluorescence was detected as discrete vesicles on the cartilage surfaces, inside the cartilaginous matrix and within the synovial space. The number of DiO-labelled vesicles in multiple fields of view was consistent and >100 in sections from four different treated knees. DiO and anti-PEG mAb co-localised within the collagenous tissues in four different joint sections. Under higher magnification (40x), vesicles were seen in the intercellular spaces of the synovial joint tissue, but no fluorescence was seen inside cells. These data suggest that the phospholipid vesicles in TDT 064 localize at the surface of the joint cartilage; these vesicles may therefore be supplementing the phospholipid deficiency reported in OA and acting as a biolubricant within the synovial joint.

Keywords: joint pain, osteoarthritis, phospholipid vesicles, TDT 064

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