Search results for: nutrition therapy guide

Authors: Javad Sadidi, Ehsan Babaei, Hani Rezayan

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The advent of web 2.0 gives a possibility to scale down the costs of data collection and mapping, specifically if the process is done by volunteers. Every volunteer can be thought of as a free and ubiquitous sensor to collect spatial, descriptive as well as multimedia data for tourist services. The lack of large-scale information, such as real-time climate and weather conditions, population density, and other related data, can be considered one of the important challenges in developing countries for tourists to make the best decision in terms of time and place of travel. The current research aims to design and implement a spatiotemporal web map service using volunteer-submitted data. The service acts as a tourist-guide service in which tourists can search interested places based on their requested time for travel. To design the service, three tiers of architecture, including data, logical processing, and presentation tiers, have been utilized. For implementing the service, open-source software programs, client and server-side programming languages (such as OpenLayers2, AJAX, and PHP), Geoserver as a map server, and Web Feature Service (WFS) standards have been used. The result is two distinct browser-based services, one for sending spatial, descriptive, and multimedia volunteer data and another one for tourists and local officials. Local official confirms the veracity of the volunteer-submitted information. In the tourist interface, a spatiotemporal search engine has been designed to enable tourists to find a tourist place based on province, city, and location at a specific time of interest. Implementing the tourist-guide service by this methodology causes the following: the current tourists participate in a free data collection and sharing process for future tourists, a real-time data sharing and accessing for all, avoiding a blind selection of travel destination and significantly, decreases the cost of providing such services.

Keywords: VGI, tourism, spatiotemporal, browser-based, web mapping

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Authors: Eitan Yefenof

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Glucocorticoid (GC) hormones, e.g. Dexamethasone and Prednisone, are widely used in the therapy of leukemia and lymphoma owing to their apoptogenic effect on lymphoid cells. However, the emergence of GC resistant cells during therapy is a major cause for treatment failure, urging the need for novel strategies that maintain leukemia sensitivity to the pro-apoptotic activity of GCs. GCs act by binding to the GC receptor (GR), which, in its inactive state, is sequestered in the cytosol by a multi-subunit complex of heat shock proteins. Upon ligand binding, the complex dissociates, allowing GR activation and translocation to the nucleus, where it regulates transcription of multiple genes. We demonstrated that in addition to gene expression, GR also regulates microRNA (miR) expression. Deep-sequencing analysis revealed 14 miRs that are regulated in GC-sensitive but resistant leukemias upon treatment with GC. GC up-regulates miR-103, miR-15~16 and miR-30e/d, while down-regulates miR-17, mir-18a, miR-19a, miR-19b, miR-20a and miR-92a (members of the miR-17∼92a multi-cistron). Upon transfection, miR-103 confers GC apoptotic sensitivity to otherwise GC-resistant cell. Furthermore, knocking down miR-103 expression reduces the GC apoptotic response of sensitive cells. miR-103 abrogates c-Myc expression, an oncogenic transcription factor which is deregulated in many cancers. In addition, miR-103 up-regulates Bim, a pro-apoptotic protein crucial for GC-induced death. Activated glycogen synthase kinase 3 (GSK3) is also crucial for GC-induced apoptosis. GSK3 is active in GC-sensitive but not in GC-resistant cells. We found that GSK3 associates with the GR multi-subunit complex. Upon GC exposure, it dissociates from the GR and interacts with Bim to enable activation of the mitochondrial apoptosis pathway. miR-103 mediated c-Myc ablation is followed by down-regulation of the multi-cistron miR-17~92a, in particular miR-18a and miR-20a. miR-18a targets GR for degradation whereas miR-20a targets Bim degradation. Hence, miR-103 acts, in concert with Bim and GR, as a "tumor suppressor" that leads to reduced proliferation, cell-cycle arrest and cell death. We suggest that miR-103 can provide a diagnostic tool that predicts the sensitivity of leukemia to GC based therapy. Furthermore, exosomal delivery of miR-103 or up-regulation of the endogenous miR-103 could confer apoptotic sensitivity to resistant cells at the outset, thus becoming a useful therapeutic tool combined with GCs.

Keywords: apoptosis, leukemia, micro-RNA, steroids

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Authors: Safoin Aktaou, Aya Al Masri, Kamel Guerchouche, Malorie Martin, Fouad Maaloul

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Introduction: In the ‘Magnetic Resonance Imaging (MRI)’ department, all workers involved in preparing the patient, setting it up, tunnel cleaning, etc. are likely to be exposed to ‘ElectroMagnetic fields (EMF)’ emitted by the MRI device. Exposure to EMF can cause adverse radio-biological effects to workers. The purpose of this study is to propose an organizational process to manage and control EMF risks. Materials and methods: The study was conducted at seven MRI departments using machines with 1.5 and 3 Tesla magnetic fields. We assessed the exposure of each one by measuring the two electromagnetic fields (static and dynamic) at different distances from the MRI machine both inside and around the examination room. Measurement values were compared with British and American references (those of the UK's ‘Medicines and Healthcare Regulatory Agency (MHRA)’ and the ‘American Radiology Society (ACR)’). Results: Following the results of EMF measurements and their comparison with the recommendations of learned societies, a zoning system that adapts to needs of different MRI services across the country has been proposed. In effect, three risk areas have been identified within the MRI services. This has led to the development of a good practice guide related to the magnetic protection of MRI workers. Conclusion: The guide established by our study is a standard that allows MRI workers to protect themselves against the risk of electromagnetic fields.

Keywords: comparison with international references, measurement of electromagnetic fields, magnetic protection of workers, magnetic resonance imaging

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Authors: Surita Maini

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There are many perceived advantages of microwave ablation have driven researchers to develop innovative antennas to effectively treat deep-seated, non-resectable hepatic tumors. In this paper a coaxial antenna with a miniaturized sleeve choke has been discussed for microwave interstitial ablation therapy, in order to reduce backward heating effects irrespective of the insertion depth into the tissue. Two dimensional Finite Element Method (FEM) is used to simulate and measure the results of miniaturized sleeve choke antenna. This paper emphasizes the importance of factors that can affect simulation accuracy, which include mesh resolution, surface heating and reflection coefficient. Quarter wavelength choke effectiveness has been discussed by comparing it with the unchoked antenna with same dimensions.

Keywords: microwave ablation, tumor, finite element method, coaxial slot antenna, coaxial dipole antenna

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Authors: Lena Lapidot, Amir Amnon, Rita Nosenko, Veitsman Ella, Cohen-Ezra Oranit, Davidov Yana, Segev Shlomo, Koren Omry, Safran Michal, Ben-Ari Ziv

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Introduction: Hepatocellular carcinoma (HCC) is one of the leading causes of cancer related mortality worldwide. Liver Cirrhosis is the main predisposing risk factor for the development of HCC. The factor(s) influencing disease progression from Cirrhosis to HCC remain unknown. Gut microbiota has recently emerged as a major player in different liver diseases, however its association with HCC is still a mystery. Moreover, there might be an important association between the gut microbiota, nutrition, life style and the progression of Cirrhosis and HCC. The aim of our study was to characterize the gut microbial signature in association with life style and nutrition of patients with Cirrhosis, HCC-Cirrhosis and healthy controls. Design: Stool samples were collected from 95 individuals (30 patients with HCC, 38 patients with Cirrhosis and 27 age, gender and BMI-matched healthy volunteers). All participants answered lifestyle and Food Frequency Questionnaires. 16S rRNA sequencing of fecal DNA was performed (MiSeq Illumina). Results: There was a significant decrease in alpha diversity in patients with Cirrhosis (qvalue=0.033) and in patients with HCC-Cirrhosis (qvalue=0.032) compared to healthy controls. The microbiota of patients with HCC-cirrhosis compared to patients with Cirrhosis, was characterized by a significant overrepresentation of Clostridium (pvalue=0.024) and CF231 (pvalue=0.010) and lower expression of Alphaproteobacteria (pvalue=0.039) and Verrucomicrobia (pvalue=0.036) in several taxonomic levels: Verrucomicrobiae, Verrucomicrobiales, Verrucomicrobiaceae and the genus Akkermansia (pvalue=0.039). Furthermore, we performed an analysis of predicted metabolic pathways (Kegg level 2) that resulted in a significant decrease in the diversity of metabolic pathways in patients with HCC-Cirrhosis (qvalue=0.015) compared to controls, one of which was amino acid metabolism. Furthermore, investigating the life style and nutrition habits of patients with HCC-Cirrhosis, we found significant correlations between intake of artificial sweeteners and Verrucomicrobia (qvalue=0.12), High sugar intake and Synergistetes (qvalue=0.021) and High BMI and the pathogen Campylobacter (qvalue=0.066). Furthermore, overweight in patients with HCC-Cirrhosis modified bacterial diversity (qvalue=0.023) and composition (qvalue=0.033). Conclusions: To the best of the our knowledge, we present the first report of the gut microbial composition in patients with HCC-Cirrhosis, compared with Cirrhotic patients and healthy controls. We have demonstrated in our study that there are significant differences in the gut microbiome of patients with HCC-cirrhosis compared to Cirrhotic patients and healthy controls. Our findings are even more pronounced because the significantly increased bacteria Clostridium and CF231 in HCC-Cirrhosis weren't influenced by diet and lifestyle, implying this change is due to the development of HCC. Further studies are needed to confirm these findings and assess causality.

Keywords: Cirrhosis, Hepatocellular carcinoma, life style, liver disease, microbiome, nutrition

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Authors: Jiri Nepereny, Vladimir Vrzal

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Staphylococcus intermedius/pseudintermedius bacteria are commonly found on the skin of healthy dogs and can cause pruritic skin diseases under certain circumstances (trauma, allergy, immunodeficiency, ectoparasitosis, endocrinological diseases, glucocorticoid therapy, etc.). These can develop into complicated superficial or deep pyoderma, which represent a large group of problematic skin diseases in dogs. These are predominantly inflammations of a secondary nature, associated with the occurrence of coagulase-positive Staphylococcus spp. A major problem is increased itching, which greatly complicates the healing process. The aim of this work is to verify the efficacy of the developed preparation Bacteriophage SI (Staphylococcus intermedius). The tested preparation contains a lysate of bacterial cells of S. intermedius host culture including culture medium and live virions of specific phage. Sodium Merthiolate is added as a preservative in a safe concentration. Validation of the efficacy of the product was demonstrated by monitoring the therapeutic effect after application to indicated cases from clinical practice. The indication for inclusion of the patient into the trial was an adequate history and clinical examination accompanied by sample collection for bacteriological examination and isolation of the specific causative agent. Isolate identification was performed by API BioMérieux identification system (API ID 32 STAPH) and rep-PCR typing. The suitability of therapy for a specific case was confirmed by in vitro testing of the lytic ability of the bacteriophage to lyse the specific isolate = formation of specific plaques on the culture isolate on the surface of the solid culture medium. So far, a total of 32 dogs of different sexes, ages and breed affiliations with different symptoms of staphylococcal dermatitis have been included in the testing. Their previous therapy consisted of more or less successful systemic or local application of broad-spectrum antibiotics. The presence of S. intermedius/pseudintermedius has been demonstrated in 26 cases. The isolates were identified as a S. pseudintermedius, in all cases. Contaminant bacterial microflora was always present in the examined samples. The test product was applied subcutaneously in gradually increasing doses over a period of 1 month. After improvement in health status, maintenance therapy was followed by application of the product once a week for 3 months. Adverse effects associated with the administration of the product (swelling at the site of application) occurred in only 2 cases. In all cases, there was a significant reduction in clinical signs (healing of skin lesions and reduction of inflammation) after therapy and an improvement in the well-being of the treated animals. A major problem in the treatment of pyoderma is the frequent resistance of the causative agents to antibiotics, especially the increasing frequency of multidrug-resistant and methicillin-resistant S. pseudintermedius (MRSP) strains. Specific phagolysate using for the therapy of these diseases could solve this problem and to some extent replace or reduce the use of antibiotics, whose frequent and widespread application often leads to the emergence of resistance. The advantage of the therapeutic use of bacteriophages is their bactericidal effect, high specificity and safety. This work was supported by Project FV40213 from Ministry of Industry and Trade, Czech Republic.

Keywords: bacteriophage, pyoderma, staphylococcus spp, therapy

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Authors: Zeytu G. Asfaw, Serkalem K. Abrha, Demisew G. Degefu

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Background: HIV/AIDS remains a major public health problem in Ethiopia and heavily affecting people of productive and reproductive age. We aimed to compare the performance of Parametric Survival Analysis and Bayesian Survival Analysis using simulations and in a real dataset application focused on determining predictors of HIV patient survival. Methods: A Parametric Survival Models - Exponential, Weibull, Log-normal, Log-logistic, Gompertz and Generalized gamma distributions were considered. Simulation study was carried out with two different algorithms that were informative and noninformative priors. A retrospective cohort study was implemented for HIV infected patients under Highly Active Antiretroviral Therapy in Alamata General Hospital, North Ethiopia. Results: A total of 320 HIV patients were included in the study where 52.19% females and 47.81% males. According to Kaplan-Meier survival estimates for the two sex groups, females has shown better survival time in comparison with their male counterparts. The median survival time of HIV patients was 79 months. During the follow-up period 89 (27.81%) deaths and 231 (72.19%) censored individuals registered. The average baseline cluster of differentiation 4 (CD4) cells count for HIV/AIDS patients were 126.01 but after a three-year antiretroviral therapy follow-up the average cluster of differentiation 4 (CD4) cells counts were 305.74, which was quite encouraging. Age, functional status, tuberculosis screen, past opportunistic infection, baseline cluster of differentiation 4 (CD4) cells, World Health Organization clinical stage, sex, marital status, employment status, occupation type, baseline weight were found statistically significant factors for longer survival of HIV patients. The standard error of all covariate in Bayesian log-normal survival model is less than the classical one. Hence, Bayesian survival analysis showed better performance than classical parametric survival analysis, when subjective data analysis was performed by considering expert opinions and historical knowledge about the parameters. Conclusions: Thus, HIV/AIDS patient mortality rate could be reduced through timely antiretroviral therapy with special care on the potential factors. Moreover, Bayesian log-normal survival model was preferable than the classical log-normal survival model for determining predictors of HIV patients survival.

Keywords: antiretroviral therapy (ART), Bayesian analysis, HIV, log-normal, parametric survival models

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Authors: Hamnah Nisar

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As food is something which is particularly important for survival, in fact, it improves the quality of life and promotes health. Quality food is a key to a healthy life. Consumption of food depends on the knowledge we have regarding the nutrients it contains. Moreover, the awareness and knowledge about something is an initial stage for its improvement. We cannot work on anything unless we have knowledge about it. The pros and cons, effects, causes, dos, and don'ts, especially for an important things like food, are a necessity to learn. That is why my research would be all about analyzing what difference awareness makes on people and how making people more aware about a certain thing can help them improve their lifestyles and bring a positive change for them. The research would be done through questionnaires and interviews among two classes, one would be the upper class and the other would-be lower class. Because the upper class can easily access learning facilities and can know about the new things than the lower class. The questions would be related to what kind of food do they consume, what health issues they face, or what health issues are common among their regions. The results of the research would be helpful to know firstly the effects of awareness and education regarding food on health, how a basic thing like knowledge can have a significant effect on health and can be the cause of several diseases.

Keywords: nutrition, awareness, quality food, knowledge

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Authors: Ayse Inel Manav, Nuray Simsek

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The number of people with dementia and the problems that are experienced by these people are increasing along with aging world population. This study was carried out to assess the effects of reminiscence therapy using internet videos on the cognitive condition and apathy levels of elderly people who had mild dementia and lived in nursing homes. This randomly controlled experimental study was conducted between 25 May-25 August 2016 in the nursing home, elderly care and rehabilitation centers in Adana and Seyhan, Turkey. A total of 32 individuals participated in this study, 16 in the experimental group and 16 in the control group. Data were collected using a personal information form developed on the basis of the published literature, the Standardized Mini Mental Test (SMMT) and the Apathy Rating Scale (ARS). The Clinical Research Ethics Committee's approval, written institutional permission, and the written consent of the participants were obtained before data collection. The individuals in the experimental group received reminiscence therapy using internet videos for 60 minutes one day a week for three months. During the same period, 25-30 minutes of unstructured interviews on subjects unrelated to reminiscence were carried out with individuals in the control group. The SMMT and ARS were administered before the applications in the experimental group and at the end of the third month. The collected data were analyzed using descriptive statistics (means, standard deviations, and frequencies) as well as Student's t-test, the Mann-Whitney U-test, and Wilcoxon's signed ranks test. In this study, the total SMMT post-test scores of the experimental group were higher than those of the control group (p = 0.001; p < 0.01). There was a difference between experimental and control groups' total SMMT post-test scores (p = 0.001; p < 0.01). The experimental group's ARS total post-test scores were higher than those of the control group (p = 0.001; p < 0.01). This study found that group reminiscence therapy using internet videos improved the cognitive functions and apathy levels of elderly individuals with mild dementia.

Keywords: apaty, cognitive testing, dementia, elderly, reminisence threapy

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Authors: Deepak Ganjiwale, Karthik Vishwanathan

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Objective: Splinting is a great domain of occupational therapy profession.Making a splint for the patient would depend upon the need or requirement of the problems and deformities. Swan neck deformity is not very common in finger it may occur after any disease. Conservative treatment of the swan neck deformity is available by using different static splints only. There are very few reports of surgical correction of swan-neck deformity in benign hypermobility syndrome. Method: This case report describes the result of surgical intervention and hand splint in a twenty year old lady with past history of cardiovascular stroke with no residual neurological deficit. She presented with correctable swan neck deformity and failed to improve with static ring splints to correct the deformity. She was noted to have hyperlaxity (EhlerDanlos type) as per modified Beighton’s score of 5/9. She underwent volar plate plication of the proximal interphalangeal joint of the left ring finger along with hemitenodesis of ulnar slip of flexor digitorum superficialis (FDS) tendon whereby, the ulnar slip of FDS was passed through a small surgically created rent in A2 pulley and sutured back to itself. Result: Postoperatively, the patient was referred to occupational therapy for splinting with the instruction that the splint would work some time for as static and some time as dynamic for positional and correction of the finger. Conclusion: After occupational therapy intervention and splinting, the patient had a full correction of the swan-neck deformity with near full flexion of the operated finger and is able to work independently.

Keywords: swan neck, finger, deformity, splint, hypermobility

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Authors: Zayedali Shaikh

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Increasingly now more than ever, UV damage brings with it a litany of minor deformities that can range from mild lesions and discoloring to cataracts and blindness. Pluripotent stem cells in planaria and human skin can be used to treat wounds and skin damage, with the primary limitations being inadequate growth factors. Photobiomodulation therapy in the form of low-intensity red light therapy has been proven to provide helpful benefits in the healing of skin that displays some of the symptoms of UV damage, such as burns and lesions, along with stimulating the proliferation of stem cells in recellularizing tissue. This paper puts forth an alternate means by which to treat the effects of UV damage using the freshwater planarian model system, Dugesia dorotocephala, known for its regenerative abilities and abundance of pluripotent stem cells, which allow for the rapid growth and repair of missing or damaged structures. Our work consisted of exposing planaria to different types of light: red light, blue light, white light, darkness, red and blue light together, UV light, and finally, red and UV light together. The primary focus of this research was on the red and UV lights, with six controls acting as metrics to compare our findings. Through computer-assisted morphological analysis, the results show that there is no significant difference in the rates of regeneration of planaria treated with simultaneous exposure to red and UV light versus planaria in darkness (p > .05), a representation of their preferred natural habitat. Our research suggests the viability of red-light therapy in actively combating UV damage and expediting the growth of epidermal stem cells by acting as another growth factor.

Keywords: regenerative medicine, stem cells, planaria, photobiomodulation

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Authors: Eric Spruth, Lindsey Herbert, Danielle DiCristofano, Isis Violet Spruth, Drake Von Spruth

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Turning dreams into reality, the lifelong passion of Mr. Spruth and the company is to transform garbage-filled courtyards into flourishing flower and vegetable gardens, bringing light, hope, and wellness to not just the space but to the populations served within these public and private spaces. As an Expressive Art Therapist at Cook County Jail, Eric Spruth has implemented gardening projects, mobile radish carts, plant fostering systems, and large-scale murals. Lindsey Herbert, the Manager of Operations and Events at the International Museum of Surgical Science, supports gardening projects with Mr. Spruth along the front lawn of the museum, which will eventually accumulate into a community wellness garden. Mr. Spruth and Ms. Herbert both have dedicated efforts towards fostering awareness of hope and help and accountability for physical and mental wellbeing. Medicinal plants can rightfully be called one of nature’s wonderful healing tools with therapeutic powers. They can inhibit and kill bacteria, lower blood pressure, blood cholesterol, and blood sugar, prevent blood clotting, boost the immune system, and serve as a digestive aid. Some plants have the ability to stimulate the lymphatic system, which expedites the removal of waste products from the body to fight off evil toxins. Many plants are considered effective antioxidants to protect cells against free radical damage, serving to prevent some forms of cancer, heart disease, strokes, and viral infections. Garlic alone can provide us with over two hundred unusual chemicals that have the capability of protecting the human body from a wide variety of diseases. Besides the medicinal qualities of plants, plant and vegetable gardens also have an echoing effect on non-participants to look at something beautiful rather than a concrete courtyard or an unkempt lawn in front of a beautiful building. Plants also purify spaces and affect mood with color therapy. Collective gardening can foster a sense of community and purpose. Additionally, by recognizing the ever-evolving planet with global warming, horticulture therapy teaches important lessons in responsibility, accountability, and sustainability. Growing local food provides an opportunity to be involved in your own mental and physical health and gives you a chance for your own self-resilience, combating depression and a lack of nutrition. In adolescents, the process of watering and caring for plants can teach important life lessons that transcend beyond the garden by providing knowledge on how to care for yourself and how to be an active member of society. It also gives a sense of purpose and pride in transforming a small seed into a plant that can be consumed or enjoyed by others. Mr. Spruth and Ms. Herbert recognize the importance of bringing more green spaces to urban areas, both to serve a nutritional benefit and provide a beautiful transformation to underutilized areas. Gardens can bring beauty, wellness, and hope to dark spaces and provide immeasurable benefits for all.

Keywords: growth, hope, mental health, sustainability, transformation, wellness

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Authors: Donald Kushon, Jyoti Pillai

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Psychogenic Non-epileptic Seizure Disorder (PNES) is a challenging clinical problem for the neurologist. This study explores the benefits of on-site collaboration between psychiatry and neurology in the management of PNES. A 3 month period at a university hospital seizure clinic is described detailing specific management approaches taken as a result of this collaboration. This study describes four areas of interest: (1. After the video EEG results confirm the diagnosis of PNES, the presentation of the diagnosis of PNES to the patient. (2. The identification of co-morbid psychiatric illness (3. Treatment with specific psychotherapeutic interventions (including Cognitive Behavioral Therapy) and psychopharmacologic interventions (primarily SSRIs) and (4. Preliminary treatment outcomes.

Keywords: cognitive behavioral therapy (CBT), psychogenic non-epileptic seizure disorder (PNES), selective serotonin reuptake inhibitors (SSRIs), video electroencephalogram (VEEG)

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Authors: Rohit Sane, Pravin Ghadigaonkar, Purvi Ahuja, Suvarna Tirmare, Archana Kelhe, Kranti Shinde, Rahul Mandole

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To evaluate the efficacy of Comprehensive Diabetic Care Program with the reduction of HbA1c in overweight Diabetes Mellitus Type II patients retrospectively. Methods: Retrospective study was carried out on 34 overweight type II diabetic patients (Mean Age = 54.58 ±11.38 yrs). A total of 34 patients were enrolled after screening of 68 patients (HbA1c 7-10%). The patients were on concomitant drugs namely insulin (11.76%), DPP-4 inhibitor (17.64%), Biguanide (55.88%), Sulfonylurea (52.94%), thiazolidinedione (11.76%), other medications (20.58%) and no allopathic medications (14.70%). The patients were given Comprehensive Diabetic Care Program consisting of panchkarma procedures namely snehana (external oleation), swedana (passive heat therapy) and basti (enema), which was completed in 15 sittings. During the therapy and next 90 days, the patients followed low carbohydrate and moderate protein & fat diet. The primary endpoint of this study was the evaluation of reduction in HbA1c at the end of the follow-up after 90 days. Results: Thirty-four overweight type II diabetic patients (mean age: 54.58[±11.38], HbA1c[7-10%], 67.64% male and 32.35% female) were enrolled in the study. A significant reduction was observed in HbA1c levels (14.30%, p<0.05) at the end of the 90 days follow-up as compared to baseline. Also, BMI was reduced by 5.87%. There was reduction in the usage of the concomitant drugs namely insulin (2.94%), DPP-4 inhibitor (2.94%), Biguanide (32.35%), Sulfonylurea (35.29%), thiazolidinedione (5.88%), other medications(17.64%) and no allopathic medications (32.35%). Conclusion: The results of the study highlight not only in the reduction of HbA1c, but also in BMI and drug tapering of the CDC program in the overweight type II diabetic patients with HbA1c (7-10%).

Keywords: HbA1c, low carb diet, Panchakarma therapy, Type II Diabetes

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Authors: Shahjada Selim

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Background: Erectile dysfunction (ED) is an important impediment to quality of life of men. ED is approximate, three times more common in diabetic than non-diabetic men, and diabetic men develop ED earlier than age-matched non-diabetic subjects. Glycemic control and other factors may contribute in developing and or deteriorating ED. Aim: The aim of the study was to determine the prevalence of ED and its risk factors in type 2 diabetic (T2DM) men in Bangladesh. Methods: During 2013-2014, 3980 diabetic men aged 30-69 years were interviewed at the out-patient departments of seven diabetic centers in Dhaka by using the validated Bengali version of the questionnaire of the International index of erectile function (IIEF) for evaluation of baseline erectile function (EF). The indexes indicate a very high correlation between the items and the questionnaire is consistently reliable. Data were analyzed with Chi-squared (χ²) test using SPSS software. P ≤ 0.05 was considered significant. Results: Out of 3790, ED was found in 2046 (53.98%) of T2DM men. The prevalence of ED was increased with age from 10.5% in men aged 30-39 years to 33.6% in those aged over 60 years (P < 0.001). In comparison with patients with reported diabetes lasting ≤ 5 years (26.4%), the prevalence of ED was less than in those with diabetes of 6-11 years (35.3%) and of 12-30 years (42.5%, P <0.001). ED increased significantly in those who had poor glycemic control. The prevalence of ED in patients with good, fair and poor glycemic control was 22.8%, 42.5% and 47.9% respectively (P = 0.004). Treatment modalities (medical nutrition therapy, oral agents, insulin, and insulin plus oral agents) had significant association with ED and its severity (P < 0.001). Conclusion: Prevalence of ED is very high among T2DM men in Bangladesh and can be reduced the burden by improving glycemic status. Glycemic control, duration of diabetes, treatment modalities, increasing age are associated with ED.

Keywords: erectile dysfunction, diabetes, men, Bangladesh

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Authors: Prajakta Bhadgaonkar

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Forgiveness is taught since birth in Indian tradition. However, delivering a disabled child is a trauma for the parents. They keep on blaming themselves for the fault, which they are not responsible. Hence, due to lack of forgiving oneself the quality of life of both parent and child gets affected. In forgiveness, person tries to relieve oneself from the feeling of hatred towards oneself or other person. Forgiveness helps move ahead in the life. Hence, one can handle problem more efficiently resulting into better quality of life. In this study, the 30 parents of children with intellectual disability were contacted to find out quality of life. They were administered standardized measure of quality of life (QOL). The children were between 6 to 8 years of age. Out of these 30 parents, 12 parents (7 females and 5 males) were given forgiveness therapy for three months span. After every one month, the QOL scale was administered. At the end of three months, the significant difference was observed in quality of life of parents of children with intellectual disability. Genderwise there was no significant difference between male and female on quality of life.

Keywords: children with intellectual disability, forgiveness, parents, quality of life

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Authors: Bokolombe Pitchou Ngoy, John Mack, Tebello Nyokong

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Synthesis and photochemical studies of BODIPY dyes have been investigated in this work in order to have a broad benchmark of this functionalized photosensitizer for biological applications such as photodynamic therapy or antimicrobial activity. The common acid catalyzed synthetic method was used, and BODIPY dyes were obtained in quite a good yield (25 %) followed by bromination and Knoevenagel condensation to afford the BODIPY dyes conjugated with maximum absorbance in the near-infrared region of the electromagnetic spectrum. The fluorescence lifetimes, fluorescence quantum yield, and Singlet oxygen quantum yield of the conjugated BODIPY dyes were determined in different solvents by using Time Correlation Single Photon Counting (TCSPC), fluorimeter, and Laser Flash Photolysis respectively. It was clearly shown that the singlet oxygen quantum yield was higher in THF followed by DMSO compared to another solvent. The same trend was observed for the fluorescence lifetimes.

Keywords: BODIPY, photodynamic therapy, photosensitizer, singlet oxygen

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Authors: Daryl Clement Knutt, Neela Badrie, Marsha Singh

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Quality assurance and product labelling are vital in the food and drink industry, as a tactical tool in a competitive environment. The food label is a principal marketing tool which also serves as a regulatory mechanism in the safeguarding of consumer well –being. The objective of this study was to evaluate the level of consumers’ use and understanding of food labeling information and knowledge pertaining to food quality assurance systems. The study population consisted of Trinidadian adults, who were over the age of 18 (n=384). Data collection was conducted via a self-administered questionnaire, which contained 31 questions, comprising of four sections: I. socio demographic information; II. food quality and quality assurance; III. use of Labeling information; and IV. laws and regulations. Sampling was conducted at six supermarkets, in five major regions of the country over a period of three weeks in 2014. The demographic profile of the shoppers revealed that majority was female (63.6%). The gender factor and those who were concerned about the nutrient content of their food, were predictive indicators of those who read food labels. Most (93.1%) read food labels before purchase, 15.4% ‘always’; 32.5% ‘most times’ and 45.2% ‘sometimes’. Some (42%) were often satisfied with the information presented on food labels, whilst 35.7% of consumers were unsatisfied. When the respondents were questioned on their familiarity with terms ‘food quality’ and ‘food quality assurance’, 21.3% of consumers replied positively - ‘I have heard the terms and know a lot’ whilst 37% were only ‘somewhat familiar’. Consumers were mainly knowledgeable of the International Standard of Organization (ISO) (51.5%) and Good Agricultural Practices GAP (38%) as quality tools. Participants ranked ‘nutritional information’ as the number one labeling element that should be better presented, followed by ‘allergy notes’ and ‘best before date’. Females were more inclined to read labels being the household shoppers. The shoppers would like better presentation of the food labelling information so as to guide their decision to purchase a product.

Keywords: food labels, food quality, nutrition, marketing, Trinidad, Tobago

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Authors: Pornnapat Berndt

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The purpose of this research is to study the tourism routes in Bangnoi Floating Market, Bangkhontee District, Samut Songkhram province, Thailand in order to create type and form of interpretation to promote cultural tourism based on local community and visitor requirement. To accomplish the goals and objectives, qualitative research will be applied. The research instruments used are observation, questionnaires, basic interviews, in-depth interviews, focus group, interviewed of key local informants including site visitors. The study also uses both primary data and secondary data. A Statistical Package for Social Sciences (SPSS) was used to analyze the data. Descriptive and inferential statistics such as tables, percentage, mean and standard deviation were used for data analysis and summary. From research result, it is revealed that the local community requirement on types of interpretation conforms to visitors require which need guide post, guide book, etc. with up to date and informally content to present Bangnoi Floating Market which got the most demand score (3.78) considered as most wanted demand.

Keywords: interpretation, cultural tourism, tourism route, local community, stakeholders participated

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Authors: Monika Verma, Renuka Sharma, B. R. Gulati, Namita Singh

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In combination therapy, two chemotherapeutic agents work together in a collaborative action. It has appeared as one of the promising approaches to improve anti-cancer treatment efficacy. In the present investigation, piperine (P-NPS), paclitaxel (PTX NPS), and a combination of both, piperine-paclitaxel nanoparticle (Pip-PTX NPS), were made by the nanoprecipitation method and later characterized by PSA, DSC, SEM, TEM, and FTIR. All nanoparticles exhibited a monodispersed size distribution with a size of below 200 nm, zeta potential ranges from (-30-40mV) and a narrow polydispersity index (>0.3) of the drugs. The average encapsulation efficiency was found to be between 80 and 90%. In vitro release of drugs for nanoparticles was done spectrophotometrically. FTIR and DSC results confirmed the presence of the drug. The Pip-PTX NPS significantly inhibit cell proliferation as compared to the native drugs nanoparticles in the breast cancer cell line MCF-7. In addition, Pip-PTX NPS suppresses cells in colony formation and soft gel agar assay. Scratch migration and Transwell chamber invasion assays revealed that combined nanoparticles reduce the migration and invasion of breast cancer cells. Morphological studies showed that Pip-PTX NPS penetrates the cells and induces apoptosis, which was further confirmed by DNA fragmentation, SEM, and western blot analysis. Taken together, Pip-PTX NPS inhibits cell proliferation, anchorage dependent and anchorage independent cell growth, reduces migration and invasion, and induces apoptosis in cells. These findings support that combination therapy using Pip-PTX NPS represents a potential approach and could be helpful in the future for breast cancer therapy.

Keywords: piperine, paclitaxel, breast cancer, apoptosis

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Authors: Alaa Abdellatif, Gabrièle Breda

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Background. Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. ATMP includes gene therapy medicinal products (GTMP), somatic cell therapy medicinal products (CTMP), and tissue-engineered therapies (TEP). Since legislation opened the way in 2007, 25 ATMPs have been approved in the EU, which is about the same amount as the U.S. Food and Drug Administration. However, not all of the ATMPs that have been approved have successfully reached the market and retained their approval. Objectives. We aim to understand all the factors limiting the market access to very promising therapies in a systemic approach, to be able to overcome these problems, in the future, with scientific, regulatory and commercial innovations. Further to recent reviews that focus either on specific countries, products, or dimensions, we will address all the challenges faced by ATMP development today. Methodology. We used mixed methods and a multi-level approach for data collection. First, we performed an updated academic literature review on ATMP development and their scientific and market access challenges (papers published between 2018 and April 2023). Second, we analyzed industry feedback from cell and gene therapy webinars and white papers published by providers and pharmaceutical industries. Finally, we established a comparative analysis of the regulatory guidelines published by EMA and the FDA for ATMP approval. Results: The main challenges in bringing these therapies to market are the high development costs. Developing ATMPs is expensive due to the need for specialized manufacturing processes. Furthermore, the regulatory pathways for ATMPs are often complex and can vary between countries, making it challenging to obtain approval and ensure compliance with different regulations. As a result of the high costs associated with ATMPs, challenges in obtaining reimbursement from healthcare payers lead to limited patient access to these treatments. ATMPs are often developed for orphan diseases, which means that the patient population is limited for clinical trials which can make it challenging to demonstrate their safety and efficacy. In addition, the complex manufacturing processes required for ATMPs can make it challenging to scale up production to meet demand, which can limit their availability and increase costs. Finally, ATMPs face safety and efficacy challenges: dangerous adverse events of these therapies like toxicity related to the use of viral vectors or cell therapy, starting material and donor-related aspects. Conclusion. As a result of our mixed method analysis, we found that ATMPs face a number of challenges in their development, regulatory approval, and commercialization and that addressing these challenges requires collaboration between industry, regulators, healthcare providers, and patient groups. This first analysis will help us to address, for each challenge, proper and innovative solution(s) in order to increase the number of ATMPs approved and reach the patients

Keywords: advanced therapy medicinal products (ATMPs), product development, market access, innovation

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Authors: Ana Luiza Da Gama E Souza

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This article aims to discuss the problem of food insecurity in Brazil in what it refers to contamination of food by chemical substances such as herbicides, pesticides, and other contaminants. The issue will be faced by analyzing, on the one hand, the standards that guide the food system in the world and, on the other hand, human rights indicators whose purpose is to provide an effective monitoring of the State's obligations to guarantee food security, analyzing the implications of the former for the success of the latter. The methodology adopted in this article was bibliographic-documentary and consists of three moments of analysis. The first moment consists in the analysis of the reports of the Commission on Human Rights of the Organization of American States to identify the set of progress indicators developed by the Commission. This analysis will involve the new methodology used to evaluate the efficiency in monitoring food security in Brazil the case of using pesticides in the production of food at levels of toxicity not admitted by the inspection bodies. The second moment consists in evaluating the mechanism for monitoring food security in Brazil, which was initially established by the National Food Security Plan (PLANSAN) for 2012-2015 and improved by the II National Food Security Plan for 2016-2019. Those mechanisms were prepared by the Chamber (CAISAN), and have the function to compare the monitoring proposals with the results presented by CAISAN on the Indicators and Results Report of the National Plan for Food and Nutrition Security 2012-2015. The third moment was intended to understand, analyze and evaluate the standardization process of the agri-food system, especially regarding the level of toxicity standards, that is related to food safety monitoring as a guarantee of pesticide-free food. The results show the dependence between private standards of toxicity and the indicators of food safety that leads to inefficiency on monitoring that mechanism in Brazil.

Keywords: standards, indicators, human rights, food security

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Authors: Natasha Yasmin Felles, Gerard Riley

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Background and Aims: Relationship breakdown is typical when one partner lives with an acquired brain injury caused by issues like a stroke. Research has found that the perception of relationship satisfaction decreases following such an injury among non-injured partners. Non-injured partners also are found to experience caregiver stress/burden as they immediately have to take the role of a caregiver along with being a partner of the injured. Research has also found that the perception of a continuous relationship, i.e. the perception of the relationship to be essentially the same as it was before the injury, also changes among those caregiving partners. However, there is a lack of available intervention strategies that can help those partners with both individual and relationship difficulties. The aim of this case study was to conduct a pilot test of an intervention aimed to explore whether it is possible to support a partner to experience greater continuity within the relationship poststroke, and what benefits such a change might have. Method: A couple, where one partner experienced an acquired brain injury poststroke were provided with Integrated Behavioural Couples Therapy for 3-months. The intervention addressed goals identified as necessary by the couple and by the formulation of their individual and relationship difficulties, alongside the goal of promoting relationship continuity. Before and after measures were taken using a battery of six questionnaires to evaluate changes in perceptions of continuity, stress, and other aspects of the relationship. Results: Both quantitative and qualitative data showed that relationship continuity was improved after the therapy, as were the measures of stress and other aspects of the relationship. The stress felt by the person with the acquired brain injury also showed some evidence of improvement. Conclusion: The study found that perceptions of relationship continuity can be improved by therapy and that improving these might have a beneficial impact on the stress felt by the carer, their satisfaction with the relationship and overall levels of conflict and closeness within the relationship. The study suggested the value of further research on enhancing perceptions of continuity in the relationship after an acquired brain injury. Currently, the findings of the study have been used to develop a pilot feasibility study to collect substantive evidence on the impact of the intervention on the couples and assess its feasibility and acceptability, which will help in further developing a specific generalized relationship continuity intervention, that will be beneficial in preventing relationship breakdown in the future.

Keywords: acquired brain injury, couples therapy, relationship continuity, stroke

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Authors: Therese Scali

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Couple separations and divorces seem to be commonplace events. However, their frequency does not reduce their impact. Indeed, the adverse effects of parental divorce on children have been well documented. Thus, supporting the children from divorced families is a key concern. Several preventive interventions have been developed for children of divorced parents, such as Children’s Support Group. The present paper aims at presenting the program that has been created in Liege (Belgium). The setting and the tools will be presented. This Children’s Support Group is based on psychoeducational and systemic principles, art-therapy, and aims at acquiring coping skills and seeking social support. Also, the effectiveness of the program will be discussed. Results show that after parental divorce, a group intervention for children can be efficacious in promoting children’s well-being and parent-child communication. This paper contributes to enrich the understanding of children’s needs and to highlight the existence and efficacy of a program that helps them overcome the difficulties of divorce.

Keywords: art-therapy, children’s support group, divorce, efficacy, separation

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Authors: Mauro Callejas-Cuervo, Andrea Catherine Alarcon-Aldana, Lorena Paola Castillo-Guerra

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The software industry requires highly-trained professionals, capable of developing the roles integrated in the cycle of software development. That is why a large part of the task is the responsibility of higher education institutions; often through a curriculum established to orientate the academic development of the students. It is so that nowadays there are different models that support proposals for the improvement of the curricula for the area of Software Engineering, such as ACM, IEEE, ABET, Swebok, of which the last stands out, given that it manages and organises the knowledge of Software Engineering and offers a vision of theoretical and practical aspects. Moreover, it has been applied by different universities in the pursuit of achieving coverage in delivering the different topics and increasing the professional quality of future graduates. This research presents the structure of teaching and learning guides from the objectives of training and methodological strategies immersed in the levels of learning of Bloom’s taxonomy with which it is intended to improve the delivery of the topics in the area of Requirements Engineering. Said guides were implemented and validated in a course of Requirements Engineering of the Systems and Computer Engineering programme in the Universidad Pedagógica y Tecnológica de Colombia (Pedagogical and Technological University of Colombia) using a four stage methodology: definition of the evaluation model, implementation of the guides, guide evaluation, and analysis of the results. After the collection and analysis of the data, the results show that in six out of the seven topics proposed in the Swebok guide, the percentage of students who obtained total marks within the 'High grade' level, that is between 4.0 and 4.6 (on a scale of 0.0 to 5.0), was higher than the percentage of students who obtained marks within the 'Acceptable' range of 3.0 to 3.9. In 86% of the topics and the strategies proposed, the teaching and learning guides facilitated the comprehension, analysis, and articulation of the concepts and processes of the students. In addition, they mainly indicate that the guides strengthened the argumentative and interpretative competencies, while the remaining 14% denotes the need to reinforce the strategies regarding the propositive competence, given that it presented the lowest average.

Keywords: pedagogic guide, pedagogic strategies, requirements engineering, Swebok, teaching-learning process

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Authors: H. Yousefnia, R. Enayati, M. Hosntalab, S. Zolghadri, A. Bahrami-Samani

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Bone metastases occur in many cases at an early stage of the tumour disease, however their symptoms are recognized rather late. The aim of this study was the preparation of 153Sm-(4-{[bis-(phosphonomethyl))carbamoyl]methyl}-7,10-bis(carboxymethyl) 1,4,7,10-tetraazacyclododec-1-yl) acetic acid (BPAMD) for bone pain palliation therapy. 153Sm was produced at Tehran research reactor via 152Sm(n,γ)153Sm reaction. 200 µl of 1mg/ml BPAMD solution was added to the vial containing 1 mCi 153Sm and the mixture was heated up to 90 0C for 1 h. The radiochemical purity of the complex was measured by ITLC method. The final solution with radiochemical purity of more than 95% was injected to BALB mice and bio distribution was determined up to 48 h. SPECT images were acquired after 2 and 24 h post injection. While high bone uptake was confirmed by both the bio distribution studies and SPECT imaging, accumulation in other organs was approximately negligible. The results show that 153Sm-BPAMD can be used as an excellent tracer for bone pain palliation therapy.

Keywords: bone metastases, BPAMD, 153Sm, radiotherapy

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Authors: Nunuy Nuraeni, Vera Amalia Lestari, Atri Laranova, Viena Nissa Mien Fadhillah, Mutia, Muhammad Ikhlas Abdian Putra

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Introduction: Obesity is a common disease with high prevalence especially in developing countries including Indonesia. The obesitygenic lifestyle such as excessive intake of food, sedentary lifestyle is the major environmental etiologies of obesity. Obesity is also as one of burden disease with high morbidity due to its complication, such as diabetes mellitus and hypertension. The objective of this literature review is to know how the Epigallocathecin-3-Gallate of Green tea or Camellia sinensis effect as anti-obesity agent and reduce the complication of obesity. Material and Methods: This study based on the secondary data analysis complemented by primary data collection from several journal and textbook. We identified the effect of Epigallocathecin-3-Gallate of Green tea or Camellia sinensis as adjuvant therapy for management obesity and to prevent the complications of obesity. Results: Based on the result, Green tea or Camellia sinensis contain Epigallocathecin-3-Gallate (EGCG) that has anti-obesity effect such as induce apoptosis, inhibit adipogenesis, increasing lipolytic activity, increasing fat oxidation and thermogenesis. Discussion: EGCG are naturally distributed in green tea, that contains a biological activity that has a potential effect to treat obesity. Conclusion: EGCG are capable to treat obesity. By consuming EGCG can prevent obesity in normal health person and prevent complication in patient with obesity.

Keywords: adjuvant therapy, anti-obesity effect, complication, epigallocathecin-3-gallate, obesity

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Authors: Shazia Bano

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Nanoconjugates that integrate photo-based therapeutics and diagnostics within a single platform promise great advances in revolutionizing cancer treatments. However, to achieve high therapeutic efficacy, designing functionally efficacious nanocarriers to tightly retain the drug, promoting selective drug localization and release, and the validation of the efficacy of these nanoconjugates is a great challenge. Here we have designed smart multiagent, liposome based targeted photoactivatable multiagent nanoconjugates, doped with a photoactivatable chromophore benzoporphyrin derivative (BPD) labelled with an active targeting ligand cetuximab to target the EGFR receptor (over expressed in various cancer cells) to deliver a combination of therapeutic agents. This study establishes a tunable nanoplatform for the delivery of the photoactivatable multiagent nanoconjugates for tumor-specific accumulation and targeted destruction of cancer cells in complex cancer model to enhance the therapeutic index of the administrated drugs.

Keywords: targeting, photodynamic therapy, photoactivatable, nanoconjugates

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Authors: G. Battistoni, F. Collamati, E. De Lucia, R. Faccini, C. Mancini-Terracciano, M. Marafini, I. Mattei, S. Muraro, V. Patera, A. Sarti, A. Sciubba, E. Solfaroli Camillocci, M. Toppi, G. Traini, S. M. Valle, C. Voena

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Accelerated charged particles, mainly protons and carbon ions, are presently used in Particle Therapy (PT) to treat solid tumors. The precision of PT exploiting the charged particle high localized dose deposition in tissues and biological effectiveness in killing cancer cells demands for an online dose monitoring technique, crucial to improve the quality assurance of treatments: possible patient mis-positionings and biological changes with respect to the CT scan could negatively affect the therapy outcome. In PT the beam range confined in the irradiated target can be monitored thanks to the secondary radiation produced by the interaction of the projectiles with the patient tissue. The Dose Profiler (DP) is a novel device designed to track charged secondary particles and reconstruct their longitudinal emission distribution, correlated to the Bragg peak position. The feasibility of this approach has been demonstrated by dedicated experimental measurements. The DP has been developed in the framework of the INSIDE project, MIUR, INFN and Centro Fermi, Museo Storico della Fisica e Centro Studi e Ricerche 'E. Fermi', Roma, Italy and will be tested at the Proton Therapy center of Trento (Italy) within the end of 2017. The DP combines a tracker, made of six layers of two-view scintillating fibers with square cross section (0.5 x 0.5 mm2) with two layers of two-view scintillating bars (section 12.0 x 0.6 mm2). The electronic readout is performed by silicon photomultipliers. The sensitive area of the tracking planes is 20 x 20 cm2. To optimize the detector layout, a Monte Carlo (MC) simulation based on the FLUKA code has been developed. The complete DP geometry and the track reconstruction code have been fully implemented in the MC. In this contribution, the DP hardware will be described. The expected detector performance computed using a dedicated simulation of a 220 MeV/u carbon ion beam impinging on a PMMA target will be presented, and the result will be discussed in the standard clinical application framework. A possible procedure for real-time beam range monitoring is proposed, following the expectations in actual clinical operation.

Keywords: online range monitoring, particle therapy, quality assurance, tracking detector

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Authors: Rongrong Liu, Li Wang, Hui Xu, Jianpei Fang, Sixi Liu, Xiaolin Yin, Junbin Liang, Gaohui Yan, Yaoyun Li, Yali Zhou, Xinyu Li, Yue Li, Lei Shi, Yongrong Lai, Junjiu Huang, Xinhua Zhang

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Background: Beta-Thalassemia is caused by reduced (β+) or absent (β0) synthesis of the β-globin chains of hemoglobin. Transfusions and oral iron chelation therapy have improved the quality of life for patients with Transfusion-Dependent thalassemia (TDT). Recent advances in genome editing platforms of CRISPR-Cas9 have paved the way for induction of HbF by reactivating expression of γ-chain.Aims: We performed CRISPR-Cas9-mediated genome editing of hematopoietic stem cells to mutate HBG1/HBG2 promoter sequence, thereby representing a naturally occurring HPFH-liked mutation, producing RM-001. Here, we present an initial assessment of safety and efficacy of RM-001 in patients with TDT. Methods: Patients (6–35 y of age) with TDT receiving packed red blood cell (pRBC) transfusions of ≥100 mL/kg/y or ≥10 units/y in the previous 2 y were eligible. CD34+ cells were edited with CRISPR-Cas9 using a guide RNA specific for the binding site of BCL11A on the HBG1/2 promoter. Prior to RM-001 product infusion (day 0), patients received myeloablative conditioning with Busulfan from day-7 to day-4. Patients were monitored for AEs Hb expression.Results: Data cut as of 28 Feb 2024, 16 TDT patients have been treated with RM-001 and followed ≥3 months. 5 of these 16 patients had finished their 24 months follow up. Eleven patients have β0/β0 genotype and five patients have β0/β+ genotype. In addition to β-thalassemia, two patients had α- deletion with the genotype of --/αα. Efficacy:All patients received a single dose intravenous infusion of RM-001 cells. 5 of them had been followed 24 months or longer. All patients achieved transfusion-independent (TI, total Hb continued ≥ 9g/dL) (Figure1). Patients demonstrated sustained and clinically meaningful increases in HbF levels since 4 month post-RM-001 infusion (Figure.2). Total hemoglobin in all patients was stable at 10-12g/dL during the follow-up period. Safety:The adverse events observed after RM-001 infusion were consistent with those that are typical of Busulfan-based myeloablation. The allelic editing analysis at 6-month visit showed that the on-target allelic editing frequency in bone marrow cells was 73.44% (64.65% to 84.6%, n=13).Summary/Conclusion: This interim analysis, in which all the 19 patients age from 7.9 to 25yo met the success criteria for the trial with respect to transfusion independence, showed that autologous HBG1/2 promoter-modified CD34+ HSPCs gene therapy resulted in an adequate amount of HbF as early as 2 months after infusion led to near-normal hemoglobin levels, remained transfusion-free through the reported period without product related SAE. After RM-001 infusion, high levels of HbF proportion and on-target editing in bone marrow cells were maintained. Submitted on behalf of the RM-001 Investigators.

Keywords: thalassemian, genetherapy, CRISPR/Cas9, HbF

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