Search results for: clinical experimentation

Authors: Garima Singh

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Objectives: Behavioral Crisis Center (BCC) is a community solution to a community problem. There has been an exponential increase in the incidence and prevalence of mental health crises around the world. The effects of the crisis negatively impact our patients and their families and strain the law enforcement and emergency room. The goal of the multi-disciplinary care model is to break the crisis cycle and provide 24-7 rapid access to an acre and crisis stabilization. We initiated our first BCC care center in 2020 in the midst of the COVID pandemic and have seen a remarkable improvement in patient ‘care and positive financial outcome. Background: Mental illnesses are common in the United States. Nearly one in five U.S. adults live with a mental illness (52.9 million in 2020). This number represented 21.0% of all U.S. adults. To address some of these challenges and help our community, In May 2020, we opened our first Behavioral crisis center (BCC). Since then, we have served more than 2500 patients and is the first southwest Missouri’s first 24/7 facility for crisis–level behavioral health and substance use needs. It has been proven to be a more effective place than emergency departments, jails, or local law enforcement. Methods: BCC was started in 2020 to serve the unmet need of the community and provide access to behavioral health and substance use services identified in the community. Funding was possible with significant investment from the county and Missouri Foundation for Health, with contributions from medical partners. It is a multi-disciplinary care center consisting of Physicians, nurse practitioners, nurses, behavioral technicians, peer support specialists, clinical intake specialists, and clinical coordinators and hospitality specialists. The center provides services including psychiatry care, outpatient therapy, community support services, primary care, peer support and engagement. It is connected to a residential treatment facility for substance use treatment for continuity of care and bridging the gap, which has resulted in the completion of treatment and better outcomes. Results: BCC has proven to be a great resource to the community and the Missouri Health Coalition is providing funding to replicate the model in other regions and work on a similar model for children and adolescents. Overall, 29% of the patients seen at BCC are stabilized and discharged with outpatient care. 50% needed acute stabilization in a hospital setting and 21% required long-term admission, mostly for substance use treatment. The local emergency room had a 42% reduction in behavioral health encounters compared to the previous 3 years. Also, by a quick transfer to BCC, the average stay in ER was reduced by 10 hours and time to follow up behavioral health assessment decreased by an average of 4 hours. Uninsured patients are also provided Medicaid application assistance which has benefited 55% of individuals receiving care at BCC. Conclusions: BCC is impacting community health and improving access to quality care and substance use treatment. It is a great investment for our patients and families.

Keywords: BCC, behvaioral health, community health care, addiction treatment

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Authors: Paul Moses Ndegwa, Teresia Kabucho, Lucy Wanjiru, Esther Wanjiru, Brian Githaiga, Jecinta Wambui

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Health outcome has improved in the country since 2013 following the adoption of the new constitution in Kenya with devolved governance with administration and health planning functions transferred to county governments. 2018-2022 development agenda prioritized universal healthcare coverage, food security, and nutrition, however, the emergence of Covid-19 and the increase of non-communicable diseases pose a challenge and constrain in an already overwhelmed health system. A study was conducted July-November 2021 to establish key challenges in achieving universal healthcare coverage within the county and best practices for improved non-communicable disease control. 14 health workers ranging from nurses, doctors, public health officers, clinical officers, and pharmaceutical technologists were purposely engaged to provide critical information through questionnaires by a trained duo observing ethical procedures on confidentiality. Data analysis. Communicable diseases are major causes of morbidity and mortality. Non-communicable diseases contribute to approximately 39% of deaths. More than 45% of the population does not have access to safe drinking water. Study noted geographic inequality with respect to distribution and use of health resources including competing non-health priorities. 56% of health workers are nurses, 13% clinical officers, 7% doctors, 9%public health workers, 2% are pharmaceutical technologists. Poor-quality data limits the validity of disease-burdened estimates and research activities. Risk factors include unsafe water, sanitation, hand washing, unsafe sex, and malnutrition. Key challenge in achieving universal healthcare coverage is the rise in the relative contribution of non-communicable diseases. Improve targeted disease control with effective and equitable resource allocation. Develop high infectious disease control mechanisms. Improvement of quality data for decision making. Strengthen electronic data-capture systems. Increase investments in the health workforce to improve health service provision and achievement of universal health coverage. Create a favorable environment to retain health workers. Fill in staffing gaps resulting in shortages of doctors (7%). Develop a multi-sectional approach to health workforce planning and management. Need to invest in mechanisms that generate contextual evidence on current and future health workforce needs. Ensure retention of qualified, skilled, and motivated health workforce. Deliver integrated people-centered health services.

Keywords: multi-sectional approach, equity, people-centered, health workforce retention

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Authors: Christy M. Moen, Richard B. Townsley

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Introduction: Metastasis to the frontal bone in thyroid cancer is extremely rare. A literature review found only six cases of thyroid cancer that metastasised to the frontal bone, with two of those involving further bone sites. Case Report: The patient was originally referred to the Oral and Maxillofacial Surgery team with an isolated mass on her forehead. Biopsies were performed, which showed this was likely a metastatic deposit from thyroid cancer. CT-PET scan showed this was an isolated lesion. The patient had a total thyroidectomy, and the forehead lesion was managed with radiotherapy. On interval scanning, the patient’s bony lesion had increased in size and had new lung nodules, which likely represented further metastasis. Conclusion: Isolated bony metastases to the frontal bone are rare. An important clinical principle to remember is that a bony metastasis from an unknown primary is more likely than primary bone cancer.

Keywords: cancer, thyroid, head and neck, surgery

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Authors: Leo Nnamdi Ozurumba-Dwight

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Single-cell genomic analytical systems have proved to be a platform to isolate bulk cells into selected single cells for genomic, proteomic, and related metabolomic studies. This is enabling systematic investigations of the level of heterogeneity in a diverse and wide pool of cell populations. Single cell technologies, embracing techniques such as high parameter flow cytometry, single-cell sequencing, and high-resolution images are playing vital roles in these investigations on messenger ribonucleic acid (mRNA) molecules and related gene expressions in tracking the nature and course of disease conditions. This entails targeted molecular investigations on unit cells that help us understand cell behavoiur and expressions, which can be examined for their health implications on the health state of patients. One of the vital good sides of single-cell RNA sequencing (scRNA seq) is its probing capacity to detect deranged or abnormal cell populations present within homogenously perceived pooled cells, which would have evaded cursory screening on the pooled cell populations of biological samples obtained as part of diagnostic procedures. Despite conduction of just single-cell transcriptome analysis, scRNAseq now permits comparison of the transcriptome of the individual cells, which can be evaluated for gene expressional patterns that depict areas of heterogeneity with pharmaceutical drug discovery and clinical treatment applications. It is vital to strictly work through the tools of investigations from wet lab to bioinformatics and computational tooled analyses. In the precise steps for scRNAseq, it is critical to do thorough and effective isolation of viable single cells from the tissues of interest using dependable techniques (such as FACS) before proceeding to lysis, as this enhances the appropriate picking of quality mRNA molecules for subsequent sequencing (such as by the use of Polymerase Chain Reaction machine). Interestingly, scRNAseq can be deployed to analyze various types of biological samples such as embryos, nervous systems, tumour cells, stem cells, lymphocytes, and haematopoietic cells. In haematopoietic cells, it can be used to stratify acute myeloid leukemia patterns in patients, sorting them out into cohorts that enable re-modeling of treatment regimens based on stratified presentations. In immunotherapy, it can furnish specialist clinician-immunologist with tools to re-model treatment for each patient, an attribute of precision medicine. Finally, the good predictive attribute of scRNAseq can help reduce the cost of treatment for patients, thus attracting more patients who would have otherwise been discouraged from seeking quality clinical consultation help due to perceived high cost. This is a positive paradigm shift for patients’ attitudes primed towards seeking treatment.

Keywords: immunotherapy, transcriptome, re-modeling, mRNA, scRNA-seq

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Authors: Safak Akdemir

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The main purpose of this research is to evaluate the relationships between childhood traumas and dissociative experiences, self-perceptions and early maladaptive schemas in male convicts convicted of sexual assault crimes in prison. In our study, male convicts in prison for the crime of sexual assault constitute the experimental group, and the participants matched with this experimental group in terms of education, age and gender constitute the control group. The experimental group of the research consists of 189 male individuals who are convicted in the Ministry of Justice, General Directorate of Prisons, Istanbul/Maltepe L Type Closed Prison. The control group of this study consists of 147 adult males matched with the experimental group in terms of age, gender and education parameters. A total of 336 adult male individuals are included in the sample of this study. 46% of the experimental group were convicted of only sexual assault, 54% of them were convicted of both sexual assault and murder, injury and drug crimes. Total of five data collection tools, namely the Personal Information Form created by S. A. & E. O., Childhood Trauma Questionnaire (CTQ), the Dissociative Experiences Scale (DES), the Rosenberg Self-Esteem Scale (RSES), and the Young Schema Questionnaire-Short Form (YSQ-SF3), were completed. DES cut-off score of 99 (52.39%) of 189 convicts in the experimental group and 12 (8.17%) of 147 people in the control group was found to be 30 and above, and this result indicates the presence of pathological dissociative experiences. 180 (95.23%) of the sexual assault convicts in the experimental group had at least one childhood trauma, 154 (81.48%) were emotional neglect, 140 (74.07%) were emotional abuse, 121 (64.02%) were physical neglect, 91 (4814%) physical abuse and 70 (37.03%) sexual abuse. 168 (88.88%) of the experimental group reported multiple type of trauma and 12 (6.34%) reported single type of trauma. While the childhood traumas, isolation, abandonment and emotional deprivation schema levels of the convicts with a DES cut-off score of 30 and above are higher than the convicts with a DES cut-off score of 30 and above, their self-esteem is lower than this group. Experimental group while childhood traumas, dissociative experiences and early maladaptive schemas are higher than the control group, their self-esteem levels are lower. Dissociative experiences, abandonment and emotional deprivation early maladaptive schemas are more common in convicts aged between 18-30 years compared to convicts aged 31 and over. In addition, dissociative experiences and early maladaptive schemas of male convicts who reported physical and sexual abuse were higher than those who did not report physical and sexual abuse, while their self-esteem was at a lower level. As a result, in terms of psychotraumatology and clinical forensic psychology, dissociative disorders developed under the influence of chronic childhood traumas, with clinical interviews and psychometric measurements to be made in terms of forensic psychiatry; it is of fundamental importance to evaluate it in terms of neurosis-psychosis distinction, disability retirement, custody, malpractice, criminal and legal capacity criteria.

Keywords: crime, sexual assault, criminology, rape crimes, dissocitative disorders, maladative schemas

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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: Gabriela R. Silveira, Claudia S. Rocha, Lais S. Vitti, Jeane L. Borges, Helen B. Durgante

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Emerging adulthood occurs after adolescence in a period that maybe be marked by experimentation, identity reconfigurations, labor life demands, and insertion in the work environment, which tends to generate stress and emotional instability. Health promotion programs for the development of strengths and virtues, based on Positive Psychology, for emerging adults are sparse in Brazil. The aim of this study was to evaluate the preliminary effects of an online multi-component Positive Psychology program for the health promotion of emerging adults based on Cognitive Behavioural Therapy and Positive Psychology. The program included six online (synchronous) weekly group sessions of approximately two hours each and homework (asynchronous) activities. The themes worked were Values and self-care/Prudence, Optimism, Empathy, Gratitude, Forgiveness, and Meaning of life and work. This study presents data from a longitudinal, pre-experimental design with pre (T1) and post-test (T2) evaluation in the intervention group. 47 individuals aged between 19-30 years old participated, mean age of 24.53 years (SD=3.13), 37 females (78.7%). 42 (89.4%) self-defined as heterosexual, four (8.5%) as homosexual, and one (2.5%) as bisexual. 33 (70.2%) had incomplete higher education, four (8.5%) completed higher education, and seven (14.9%) had a graduate level of education. 27 participants worked (57.4%), out of which 25 were health workers (53.2%). 14 (29.8%) were caregivers, 27 (57.4%) had a spiritual belief, 36 (76.6%) had access to leisure, and 38 (80.9%) had perceived social support. The instruments used were a sociodemographic questionnaire, the 10-item Perceived Stress Scale, and the 12-item General Health Questionnaire. The program was advertised on social networks and interested participants filled out the Consent Form and the evaluation protocol at T1 and T2 via Google Docs form. The main research was approved (CEP n.1,899,368; 4,143,219; CAAE: 61997516.5.0000.5334) and complied with sanitary and Ethics criteria in research with human beings. Wilcoxon statistics revealed significant improvements in indicators of perceived stress between T1 (X=22.21, SD=6.79) and T2 (X=15.10, SD=5.82); (Z=-4.353; p=0.001) as well as depression and anxiety symptoms (T1:X=26.72, SD=8.84; T2: X=19.23, SD=4.68); (Z=-3.945, p=0.001) of the emerging adults after their participation in the programme. The programme has an innovative character not only for presenting an online Positive Psychology approach but also for being based on an intervention developed, evaluated, and manualized in Brazil. By focusing on emerging adults, this study contributes to advancing research on a relatively new field in developmental studies. As a limitation, this is a pre-experimental and pilot study, requiring an increase in sample size for greater statistical robustness, also qualitative data analysis is crucial for methodological complementarity. The importance of investing efforts to accompany this age group and provide advances in longitudinal research in the area of health promotion and disease prevention is highlighted.

Keywords: emerging adults, disease prevention, health promotion, online program

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Authors: Modi Alsubaie, Chris Dickens, Barnaby Dunn, Andy Gibson, Obioha Ukoumunned, Alison Evans, Rachael Vicary, Manish Gandhi, Willem Kuyken

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Background: Depression co-occurs in 20% of people with cardiovascular disorders, can persist for years and predicts worse physical health outcomes. While psychosocial treatments have been shown to effectively treat acute depression in those with comorbid cardiovascular disorders, to date there has been no evaluation of approaches aiming to prevent relapse and treat residual depression symptoms in this group. Therefore, the current study aimed to examine the feasibility and acceptability of a randomised controlled trial design evaluating an adapted version of mindfulness-based cognitive therapy (MBCT) designed specifically for people with co-morbid depression and cardiovascular disorders. Methods: A 3-arm feasibility randomised controlled trial was conducted, comparing MBCT adapted for people with cardiovascular disorders plus treatment as usual (TAU), mindfulness-based stress reduction (MBSR) plus TAU, and TAU alone. Participants completed a set of self-report measures of depression severity, anxiety, quality of life, illness perceptions, mindfulness, self-compassion and affect and had their blood pressure taken immediately before, immediately after, and three months following the intervention. Those in the adapted-MBCT arm additionally underwent a qualitative interview to gather their views about the adapted intervention. Results: 3400 potentially eligible participants were approached when attending an outpatient appointment at a cardiology clinic or via a GP letter following a case note search. 242 (7.1%) were interested in taking part, 59 (1.7%) were screened as being suitable, and 33 (<1%) were eventually randomised to the three groups. The sample was heterogeneous in terms of whether they reported current depression or had a history of depression and the time since the onset of cardiovascular disease (one to 25 years). Of 11 participants randomised to adapted MBCT seven completed the full course, levels of home mindfulness practice were high, and positive qualitative feedback about the intervention was given. Twenty-nine out of 33 participants randomised completed all the assessment measures at all three-time points. With regards to the primary outcome (depression), five out of the seven people who completed the adapted MBCT and three out of five under MBSR showed significant clinical change, while in TAU no one showed any clinical change at the three-month follow-up. Conclusions: The adapted MBCT intervention was feasible and acceptable to participants. However, aspects of the trial design were not feasible. In particular, low recruitment rates were achieved, and there was a high withdrawal rate between screening and randomisation. Moreover, the heterogeneity in the sample was high meaning the adapted intervention was unlikely to be well tailored to all participants needs. This suggests that if the decision is made to move to a definitive trial, study recruitment procedures will need to be revised to more successfully recruit a target sample that optimally matches the adapted intervention.

Keywords: mindfulness-based cognitive therapy (MBCT), depression, cardiovascular disorders, feasibility, acceptability

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Authors: Sadia Munir, Diana White, Aya Albahri, Pratiwi Hastania, Eltahir Mohamed, Mahmood Khan, Fathima Mohamed, Ayat Kadhi, Haila Saleem

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Preeclampsia is a major complication of pregnancy. Prediction and management of preeclampsia is a challenge for obstetricians. To our knowledge, no major progress has been achieved in the prevention and early detection of preeclampsia. There is very little known about the clear treatment path of this disorder. Preeclampsia puts both mother and baby at risk of several short term- and long term-health problems later in life. There is huge health service cost burden in the health care system associated with preeclampsia and its complications. Preeclampsia is divided into two different types. Early onset preeclampsia develops before 34 weeks of gestation, and late onset develops at or after 34 weeks of gestation. Different genetic and environmental factors, prognosis, heritability, biochemical and clinical features are associated with early and late onset preeclampsia. Prevalence of preeclampsia greatly varies all over the world and is dependent on ethnicity of the population and geographic region. To authors best knowledge, no published data on preeclampsia exist in Qatar. In this study, we are reporting the incidence of preeclampsia in Qatar. The purpose of this study is to compare the incidence and risk factors of both early onset and late onset preeclampsia in Qatar. This retrospective longitudinal cohort study was conducted using data from the hospital record of Women’s Hospital, Hamad Medical Corporation (HMC), from May 2014-May 2016. Data collection tool, which was approved by HMC, was a researcher made extraction sheet that included information such as blood pressure during admission, socio demographic characteristics, delivery mode, and new born details. A total of 1929 patients’ files were identified by the hospital information management when they apply codes of preeclampsia. Out of 1929 files, 878 had significant gestational hypertension without proteinuria, 365 had preeclampsia, 364 had severe preeclampsia, and 188 had preexisting hypertension with superimposed proteinuria. In this study, 78% of the data was obtained by hospital electronic system (Cerner) and the remaining 22% was from patient’s paper records. We have gone through detail data extraction from 560 files. Initial data analysis has revealed that 15.02% of pregnancies were complicated with preeclampsia from May 2014-May 2016. We have analyzed difference in the two different disease entities in the ethnicity, maternal age, severity of hypertension, mode of delivery and infant birth weight. We have identified promising differences in the risk factors of early onset and late onset preeclampsia. The data from clinical findings of preeclampsia will contribute to increased knowledge about two different disease entities, their etiology, and similarities/differences. The findings of this study can also be used in predicting health challenges, improving health care system, setting up guidelines, and providing the best care for women suffering from preeclampsia.

Keywords: preeclampsia, incidence, risk factors, maternal

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Authors: Sergei Kosarev

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Wrong treatment tactics for hand and wrist sport-related injuries can lead to the inability to play sports in the future. It is especially important for professional athletes. The members of the Russian Olympic Team are treated in our hospital -Federal Clinical Research Center (Moscow). For their treatment, we use minimally invasive methods such as wrist arthroscopy and also orthobiologics procedures. In 2022 we had cases with scaphoid fracture and TFCC injuries. In all the cases, we were using the arthroscopy technic for treatment. The scaphoid fracture was fixed by K-wires with free bone grafting. For TFCC injures we used transossal sutures. Rehabilitation started the next day after surgery. Rehabilitation included hand therapy and physiotherapy. All athletes returned to the sport after 8-12 weeks after surgery. One of them had pain in the wrist after 12 weeks after surgery, not more than 4 point VAS. Pain syndrome was blocked after 2 PRP injections in the ulnar side of the wrist.

Keywords: sport trauma, wrist arthroscopy, wrist pain, scaphoid fracture

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Authors: Omonov Jahongir Mahmatkulovic

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Purpose: To study the significance of D-dimer (DD), prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), and fibrinogen coagulation parameters (Fg) in predicting the course, severity and prognosis of COVID-19. Source and method of research: From September 15, 2021, to November 5, 2021, 93 patients aged 25 to 60 with suspected COVID-19, who are under inpatient treatment at the multidisciplinary clinic of the Tashkent Medical Academy, were retrospectively examined. DD, PT, APTT, and Fg were studied in dynamics and studied changes. Results: Coagulation disorders occurred in the early stages of COVID-19 infection with an increase in DD in 54 (58%) patients and an increase in Fg in 93 (100%) patients. DD and Fg levels are associated with the clinical classification. Of the 33 patients who died, 21 had an increase in DD in the first laboratory study, 27 had an increase in DD in the second and third laboratory studies, and 15 had an increase in PT in the third test. The results of the ROC analysis of mortality showed that the AUC DD was three times 0.721, 0.801, and 0.844, respectively; PT was 0.703, 0.845, and 0.972. (P<0:01). Conclusion”: Coagulation dysfunction is more common in patients with severe and critical conditions. DD and PT can be used as important predictors of mortality from COVID-19.

Keywords: Covid19, DD, PT, Coagulogram analysis, APTT

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Authors: Grace Omowunmi Soyebi

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A computerized medical record system is a collection of medical information about a person that is stored on a computer. One principal problem of most hospitals in rural areas is using the file management system for keeping records. A lot of time is wasted when a patient visits the hospital, probably in an emergency, and the nurse or attendant has to search through voluminous files before the patient's file can be retrieved, this may cause an unexpected to happen to the patient. This Data Mining application is to be designed using a Structured System Analysis and design method which will help in a well-articulated analysis of the existing file management system, feasibility study, and proper documentation of the Design and Implementation of a Computerized medical record system. This Computerized system will replace the file management system and help to quickly retrieve a patient's record with increased data security, access clinical records for decision-making, and reduce the time range at which a patient gets attended to.

Keywords: programming, computing, data, innovation

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Authors: Tristan R. Fraser, Christopher D. Steadman, Christopher J. Boos

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Myopericarditis is an inflammation syndrome characterised by clinical diagnostic criteria for pericarditis, such as chest pain, combined with evidence of myocardial involvement, such as elevation of biomarkers of myocardial damage, e.g., troponins. It can rarely be a complication of therapeutics used for dysregulated immune-mediated diseases such as inflammatory bowel disease (IBD), for example, mesalazine. The infrequency of mesalazine-induced myopericarditis adds to the challenge in its recognition. Rapid diagnosis and the early introduction of treatment are crucial. This case report follows a 24-year-old professional footballer with a past medical history of ulcerative colitis, recently started on mesalazine for disease control. Three weeks after mesalazine was initiated, he was admitted with fever, shortness of breath, and chest pain worse whilst supine and on deep inspiration, as well as elevated venous blood cardiac troponin T level (cTnT, 288ng/L; normal: <13ng/L). Myocarditis was confirmed on initial inpatient cardiac MRI, revealing the presence of florid myocarditis with preserved left ventricular systolic function and an ejection fraction of 67%. This was a longitudinal case study following the progress of a single individual with myopericarditis over four acute hospital admissions over nine weeks, with admissions ranging from two to five days. Parameters examined included clinical signs and symptoms, serum troponin, transthoracic echocardiogram, and cardiac MRI. Serial measurements of cardiac function, including cardiac MRI and transthoracic echocardiogram, showed progressive deterioration of cardiac function whilst mesalazine was continued. Prior to cessation of mesalazine, transthoracic echocardiography revealed a small global pericardial effusion of < 1cm and worsening left ventricular systolic function with an ejection fraction of 45%. After recognition of mesalazine as a potential cause and consequent cessation of the drug, symptoms resolved, with cardiac MRI performed as an outpatient showing resolution of myocardial oedema. The patient plans to make a return to competitive sport. Patients suffering from myopericarditis are advised to refrain from competitive sport for at least six months in order to reduce the risk of cardiac remodelling and sudden cardiac death. Additional considerations must be taken in individuals for whom competitive sport is an essential component of their livelihood, such as professional athletes. Myopericarditis is an uncommon, however potentially serious medical condition with a wide variety of aetiologies, including viral, autoimmune, and drug-related causes. Management is mainly supportive and relies on prompt recognition and removal of the aetiological process. Mesalazine-induced myopericarditis is a rare condition; as such increasing awareness of mesalazine as a precipitant of myopericarditis is vital for optimising the management of these patients.

Keywords: myopericarditis, mesalazine, inflammatory bowel disease, professional athlete

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Authors: Jiangbo Pu, Hanhui Xu, Yazhou Wang, Hongyan Cui, Yong Hu

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Spinal cord injury (SCI) brings great negative influence to the patients and society. Neurological loss in human after SCI is a major challenge in clinical. Instead, neural regeneration could have been seen in animals after SCI, and such regeneration could be retarded by blocking neural plasticity pathways, showing the importance of neural plasticity in functional recovery. Here we used sample entropy as an indicator of nonlinear dynamical in the brain to quantify plasticity changes in spontaneous EEG recordings of rats before and after SCI. The results showed that the entropy values were increased after the injury during the recovery in one week. The increasing tendency of sample entropy values is consistent with that of behavioral evaluation scores. It is indicated the potential application of sample entropy analysis for the evaluation of neural plasticity in spinal cord injury rat model.

Keywords: spinal cord injury (SCI), sample entropy, nonlinear, complex system, firing pattern, EEG, spontaneous activity, Basso Beattie Bresnahan (BBB) score

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Authors: Bei Shan Lin, Chun Mei Lu, Ya Ping Chen, Li Chen Lu

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This study explores the ethical issues concerning the use of physical restraint in geriatric care. Physical restraint use in a medical care setting is seen as a controversial form of treatment that has occurred over decades. There is no doubt that people nowadays are living longer than previous generations. The ageing process is inevitable. Common disease such as impaired comprehension, memory loss, and trouble expressing one’s self contribute to the difficulty that these older patients have in adapting to medical institution. For these reasons, physical restraint is often used in reducing the risk of falling, managing wandering behaviour, preventing agitation, and promoting patient compliance in geriatric care. It can mean that physical restraints are considered as a common practice that is used in the care of older patients. It is most commonly used for three specific purposes, including procedural restraint, restraint to prevent falls, and behavioural restraints. Although there have been well documented instances of morbidity and mortality recognised as being potential risks associated with physical restraint use, it continues to be permitted and used in healthcare, often in the name of safety. However, there is insufficient evidence supporting the effectiveness of physical restraint use reducing injuries from falls and controlling challenging behaviour in geriatric care settings. There is barely any empirical evidence of either a scientific basis or clinical trials have evaluated the improvement in patient safety following physical restraint. In difficult clinical situations, guidelines and practical suggestions for Healthcare professionals to comply requirements can help those making appropriate decisions and to facilitate better judgement regarding physical restraint use. The following recommendations are given for physical restraint use in long-term care settings: an interdisciplinary team approach to assess, evaluate, and treat underlying diseases to determine if treatment can ease issues precipitating physical restraint use; a clearly stated purpose of treatment plan should be made after weighing up the risk of physical restraint use against the risk of without physical restraint use; a care plan for physical restraint has to include individualised treatment planning, informed consent, identification and remedial action to avoid negative consequences, regular assessment and modification, reduction and removal of risks; patients and their families must have the opportunity to consider and give voluntary informed consent prior to physical restraint utilisation; patients, family members, and Healthcare professionals should be educated on use and adverse consequences of physical restraints in order to make raise awareness of potential risks and to take appropriate steps to prevent unnecessary harm; after physical restraint removal, Healthcare professionals should discuss with patients and family members about their experience, feelings, and any anxieties regarding the treatment. Physical restraint should always be considered a last resort as deprive patient’s freedom, control, and individuality. Healthcare professionals should emphasise on providing individualized care, interdisciplinary decision-making process, and creative and collaborative alternatives to promote older patient’s rights, dignity and overall well-being as much as possible.

Keywords: ethics healthcare, geriatric care, healthcare, physical restraint

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Authors: Yasser R. Shaban

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A practical multipurpose device for medical isotopes production is most wanted for clinical centers and researches. Unfortunately, the major supply of these radioisotopes currently comes from aging sources, and there is a great deal of uneasiness in the domestic market. There are also many cases where the cost of certain radioisotopes is too high for their introduction on a commercial scale even though the isotopes might have great benefits for society. The medical isotopes such as radiotracers PET (Positron Emission Tomography), Technetium-99 m, and Iodine-131, Lutetium-177 by is feasible to be generated by a single unit named IEMC (Inertial Electrostatic Magnetic Confinement). The IEMC fusion vessel is the upgrading unit of the Inertial Electrostatic Confinement IEC fusion vessel. Comprehensive experimental works on IEC were carried earlier with promising results. The principle of inertial electrostatic magnetic confinement IEMC fusion is based on forcing the binary fuel ions to interact in the opposite directions in ions cyclotrons orbits with different kinetic energies in order to have equal compression (forces) and with different ion cyclotron frequency ω in order to increase the rate of intersection. The IEMC features greater fusion volume than IEC by several orders of magnitude. The particles rate from the IEMC approach are projected to be 8.5 x 10¹¹ (p/s), ~ 0.2 microampere proton, for D/He-3 fusion reaction and 4.2 x 10¹² (n/s) for D/T fusion reaction. The projected values of particles yield (neutrons and protons) are suitable for medical isotope productions on-site by a single unit without any change in the fusion vessel but only the fuel gas. The PET radiotracers are usually produced on-site by medical ion accelerator whereas Technetium-99m (Tc-99m) is usually produced off-site from the irradiation facilities of nuclear power plants. Typically, hospitals receive molybdenum-99 isotope container; the isotope decays to Tc-99mwith half-life time 2.75 days. Even though the projected current from IEMC is lesser than the proton current from the medical ion accelerator but still the IEMC vessel is simpler, and reduced in components and power consumption which add a new value of populating the PET radiotracers in most clinical centers. On the other hand, the projected neutrons flux from the IEMC is lesser than the thermal neutron flux at the irradiation facilities of nuclear power plants, but in the IEMC case the productions of Technetium-99m is suggested to be at the resonance region of which the resonance integral cross section is two orders of magnitude higher than the thermal flux. Thus it can be said the net activity from both is evened. Besides, the particle accelerator cannot be considered a multipurpose particles production unless a significant change is made to the accelerator to change from neutrons mode to protons mode or vice versa. In conclusion, the projected fusion yield from IEMC is a straightforward since slightly change in the primer IEC and ion source is required.

Keywords: electrostatic versus magnetic confinement fusion vessel, ion source, medical isotopes productions, neutron activation

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Authors: Shamill Amedot Udonwa, Phyllis S. Y. Chong, Lim S. L. Julia, Wee-Joo Chng

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In this paper, we investigated how PRL-3 expression in H929 and U266 cells affects the efficacy of drug treatment. H929 and U266 cells were treated with Bortezomib (BTZ) of different concentrations, and it was observed that H929 cells were resistant to BTZ, while U266 cells were not viable. Investigations into how BTZ targets these cells were conducted, and it was observed that BTZ affects the PARP-Caspase3 pathway as well as PRL-3-Leo1 pathways. These pathways regulate cell proliferation and cell cycle, respectively. Hence, we are able to show the mechanism of how BTZ affects cells and also the role PRL-3 plays on downstream oncogenes such as cyclin-D1 and c-MYC. More importantly, this investigation into PRL-3 in BTZ resistance will be highly applicable in the future as the first clinical trials of PRL-3 antibody (PRL3-zumab) are ongoing at the National University Hospital, Singapore (NUHS). This would mean that understanding the mechanism of resistance through PRL-3, which has yet to be studied, will demonstrate the potential of PRL-3 in developing novel strategies to improve the treatment of MM.

Keywords: drug resistance, hematology, multiple myeloma, oncogene

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Authors: Sajad Haghshenas

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Emerging evidence from clinical, genetic, and animal model studies suggests that the N-methyl-D-aspartate (NMDA) glutamate receptors (NMDAR) may contribute to the pathophysiology and aetiology of neurological and psychiatric disorders and the patients with impaired NMDR receptors experience psychological symptoms. Therefore, we hypothesised that NMDAR receptors play a key role in the development of attention deficit hyperactivity disorder (ADHD). In this comparative analytical study, we utilized western blotting method to assay the expression levels of NMDA subunits NR1 and NR2 in the blood plasma of 50 male individuals diagnosed with ADHD in comparison to 20 healthy controls. The findings from the western blotting analysis provide support for the hypothesis that individuals with ADHD exhibit significantly lower levels of NR1/2 receptors compared to those without the disorder. Further research is needed to explore the potential causal relationship between reduced NR1/NR2 receptor levels and the development of ADHD.

Keywords: expression, glutamate receptors, NR1, NR2, ADHD

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Authors: Naiara Ozamiz Etcebarria, Sonia Ruiz De Azua Garcia, Agurtzane Ortiz Jauregi, Virginia Guillen Cañas

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Introduction: The most relevant competencies of a health professional are an adequate communication capacity, which will influence the satisfaction of professionals and patients, therapeutic compliance, conflict prevention, clinical outcomes´ improvement and efficiency of health services. The ability of Active listening , empathy, assertiveness and social skills, are important abilities to develop in all professions in which there is a relationship with other people. In the field of health, it is even more important to have adequate qualities so that the treatment with the patient will be adequate and satisfactory. We conducted a research with students of third year in the Degree of Medicine with the objectives: - to know how the active listening, empathy, assertiveness and social skills of students are. - to know if there are differences according to different demographic variables, such as sex, language, age, number of siblings and interest in the subject. Material and Methods: The students of the Third year in the Degree of Medicine (N = 212) participated voluntarily. Sociodemographic data were collected. Descriptive and comparative analysis of the averages of the students with respect to active listening, empathy, assertiveness and social skills were performed. Once the questionnaires were collected, they were entered into the SPSS 21 database. Four communicational aspects were evaluated: The active listening questionnaire, the TECA empathy questionnaire, the ACDA questionnaire and the EHS questionnaire Social Skills Scale. The active listening questionnaire assesses these factors: Listening without interruption and less contradiction, Listening with 100% attention, Listening beyond words, Listening encouraging the other to go deeper. The TECA questionnaire of cognitive and affective empathy evaluates: Adoption of perspectives, Emotional Comprehension, Emphasizing stress, Empathic joy. The EHS questionnaire Social Skills Scale: Self-expression in social situations, Defending one's own rights as a consumer, Expressing anger or dissatisfaction, Refusing to do and cutting interactions off, Making requests, Initiating positive interactions with the other sex. The ACDA questionnaire Assertiveness Assessment Scale evaluates self-assertiveness and heteroaservitivity. Applicability: To train these skills is so important for clinical practice of medical students and these capabilities that can be measured in a longitudinal way time. Ethical-legal aspects: The data were anonymous. The study was approved by the Ethics Committee. Results: The students of the Third year in the Degree of Medicine (34.4% Basque speakers and 65.6% Spanish speakers) with average age 20.93, (27.8% men and 72.2% women). There are no differences in social skills between men and women. The Basque speaker students of are more heteroactive (ACDA) than Spanish students. Active listening has a high correlation with social skills, especially with self-expression in social situations. Listening without interruption has a high correlation with self-expression in social situations and initiating positive interactions with the opposite sex. Adoption of perspectives presents a high correlation with auto- assertiveness. Emotional understanding presents a high correlation with positive interactions with the opposite sex. Empathic joy correlates with self-assertiveness, self-expression in social situations, and initiating positive interactions with the opposite sex.

Keywords: active listening, assertiveness, communicational skills, empathy, students of medicine

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Authors: M. Volpini, D. Alves, A. Horta, M. Borges, P. Reis

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The gait pattern in people that present motor limitations foment the demand for auxiliary locomotion devices. These artifacts for movement assistance vary according to its shape, size and functional features, following the clinical applications desired. Among the ortheses of lower limbs, the ankle-foot orthesis aims to improve the ability to walk in people with different neuromuscular limitations, although they do not always answer patients' expectations for their aesthetic and functional characteristics. The purpose of this study is to explore the possibility of using new design in additive manufacturer to reproduce the shape and functional features of a ankle-foot orthesis in an efficient and modern way. Therefore, this work presents a study about the performance of the mechanical forces through the analysis of finite elements in an ankle-foot orthesis. It will be demonstrated a study of distribution of the stress on the orthopedic device in orthostatism and during the movement in the course of patient's walk.

Keywords: additive manufacture, new designs, orthoses, finite elements

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Authors: Laura Gleason, Sahithi Talasila, Lauren Banner, Ladan Afifi, Neda Nikbakht

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Primary cutaneous anaplastic large cell lymphoma (pcALCL) accounts for 9% of all cutaneous T-cell lymphomas. pcALCL is classically characterized as a solitary papulonodule that often enlarges, ulcerates, and can be locally destructive, but overall exhibits an indolent course with overall 5-year survival estimated to be 90%. Distinguishing pcALCL from systemic ALCL (sALCL) is essential as sALCL confers a poorer prognosis with average 5-year survival being 40-50%. Although extremely rare, there have been several cases of ALK-positive ALCL diagnosed on skin biopsy without evidence of systemic involvement, which poses several challenges in the classification, prognostication, treatment, and follow-up of these patients. Objectives: We present a case of cutaneous ALK-positive ALCL without evidence of systemic involvement, and a narrative review of the literature to further characterize that ALK-positive ALCL limited to the skin is a distinct variant with a unique presentation, history, and prognosis. A 30-year-old woman presented for evaluation of an erythematous-violaceous papule present on her right chest for two months. With the development of multifocal disease and persistent lymphadenopathy, a bone marrow biopsy and lymph node excisional biopsy were performed to assess for systemic disease. Both biopsies were unrevealing. The patient was counseled on pursuing systemic therapy consisting of Brentuximab, Cyclophosphamide, Doxorubicin, and Prednisone given the concern for sALCL. Apropos of the patient we searched for clinically evident, cutaneous ALK-positive ALCL cases, with and without systemic involvement, in the English literature. Risk factors, such as tumor location, number, size, ALK localization, ALK translocations, and recurrence, were evaluated in cases of cutaneous ALK-positive ALCL. The majority of patients with cutaneous ALK-positive ALCL did not progress to systemic disease. The majority of cases that progressed to systemic disease in adults had recurring skin lesions and cytoplasmic localization of ALK. ALK translocations did not influence disease progression. Mean time to disease progression was 16.7 months, and significant mortality (50%) was observed in those cases that progressed to systemic disease. Pediatric cases did not exhibit a trend similar to adult cases. In both the adult and pediatric cases, a subset of cutaneous-limited ALK-positive ALCL were treated with chemotherapy. All cases treated with chemotherapy did not progress to systemic disease. Apropos of an ALK-positive ALCL patient with clinical cutaneous limited disease in the histologic presence of systemic markers, we discussed the literature data, highlighting the crucial issues related to developing a clinical strategy to approach this rare subtype of ALCL. Physicians need to be aware of the overall spectrum of ALCL, including cutaneous limited disease, systemic disease, disease with NPM-ALK translocation, disease with ALK and EMA positivity, and disease with skin recurrence.

Keywords: anaplastic large cell lymphoma, systemic, cutaneous, anaplastic lymphoma kinase, ALK, ALCL, sALCL, pcALCL, cALCL

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Authors: Raymond C. Hawkins II, Catherine A. Hawkins

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The System Contextual Integrated Model (SCIM), developed as a trans-theoretical framework for selecting measures for psychotherapy process and outcome, is reformulated for behavioral health applications. The SCIM “healing cycle” is an allostatic hedonic affective-cognitive right-hemisphere–left-hemisphere coordinated process involving positive alliesthesia that mitigates traumatic pain and generates psychological flexibility. The SCIM “trauma cycle” is an allostatic overload alliesthesia opponent process with long-lasting pathology sequelae. The social ecological context moderates the “healing cycle” and the “trauma cycle.” Repeated evocation of the “healing cycle” in a therapeutic relationship can gradually relieve trauma sequelae. The SCIM is applied to pain, obese binge eating, and substance use disorders.

Keywords: allostasis, alliesthesia, opponent process, behavioral health, assessment

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Authors: Oleg Reva, Ilya Korotetskiy, Marina Lankina, Murat Kulmanov, Aleksandr Ilin

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Molecular docking approaches are widely used for design of new antibiotics and modeling of antibacterial activities of numerous ligands which bind specifically to active centers of indispensable enzymes and/or key signaling proteins of pathogens. Widespread drug resistance among pathogenic microorganisms calls for development of new antibiotics specifically targeting important metabolic and information pathways. A generally recognized problem is that almost all molecular targets have been identified already and it is getting more and more difficult to design innovative antibacterial compounds to combat the drug resistance. A promising way to overcome the drug resistance problem is an induction of reversion of drug resistance by supplementary medicines to improve the efficacy of the conventional antibiotics. In contrast to well established computer-based drug design, modeling of drug resistance reversion still is in its infancy. In this work, we proposed an approach to identification of compensatory genetic variants reducing the fitness cost associated with the acquisition of drug resistance by pathogenic bacteria. The approach was based on an analysis of the population genetic of Mycobacterium tuberculosis and on results of experimental modeling of the drug resistance reversion induced by a new anti-tuberculosis drug FS-1. The latter drug is an iodine-containing nanomolecular complex that passed clinical trials and was admitted as a new medicine against MDR-TB in Kazakhstan. Isolates of M. tuberculosis obtained on different stages of the clinical trials and also from laboratory animals infected with MDR-TB strain were characterized by antibiotic resistance, and their genomes were sequenced by the paired-end Illumina HiSeq 2000 technology. A steady increase in sensitivity to conventional anti-tuberculosis antibiotics in series of isolated treated with FS-1 was registered despite the fact that the canonical drug resistance mutations identified in the genomes of these isolates remained intact. It was hypothesized that the drug resistance phenotype in M. tuberculosis requires an adjustment of activities of many genes to compensate the fitness cost of the drug resistance mutations. FS-1 cased an aggravation of the fitness cost and removal of the drug-resistant variants of M. tuberculosis from the population. This process caused a significant increase in genetic heterogeneity of the Mtb population that was not observed in the positive and negative controls (infected laboratory animals left untreated and treated solely with the antibiotics). A large-scale search for linkage disequilibrium associations between the drug resistance mutations and genetic variants in other genomic loci allowed identification of target proteins, which could be influenced by supplementary drugs to increase the fitness cost of the drug resistance and deprive the drug-resistant bacterial variants of their competitiveness in the population. The approach will be used to improve the efficacy of FS-1 and also for computer-based design of new drugs to combat drug-resistant infections.

Keywords: complete genome sequencing, computational modeling, drug resistance reversion, Mycobacterium tuberculosis

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Authors: Devieta Romadhon Saendardy

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Introduction: The case of aneurysmal subarachnoid hemorrhage (SAH) associated with intraventricular hemorrhage (IVH) in many way. In general, the anterior communicating artery and posterior circulation aneurysms cause Intraventricular Hemorrhage. The development of intraventricular hemorrhage (IVH) in aneurysmal subarachnoid hemorrhage (aSAH) is linked with higher mortality and poor neurological recovery. Case: This case report presents a 51-year-old female patient who developed IVH following SAH. The patient's Glasgow Coma Scale score was 14, the patient has a severe headache, and there were right extremity hemipharese neurological deficits. A non-contrast head CT scan revealed a massive intraventricular haemorrhage. In an hour, the patient got her headache and pharese worse. Discussion: Intraventricular hemorrhage is a serious complication of subarachnoid hemorrhage, necessitating prompt recognition and management. This case highlights the importance of a time management, medical management and surgical intervention to optimize outcomes in patients with intraventricular hemorrhage caused by subarachnoid hemorrhage. Placement of a shunt system improves clinical outcome in intraventricular hemorrhage.

Keywords: Intraventricular hemorrhage, subarachnoid hemorrhage, shunt, time

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Authors: Alireza Moghtaderi, Negin Khakpour

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Hallux Valgus is a kind of Toes aberration where the Metatarsophalangeal joint that connects the big toe to the foot, leading to the inner side and a protrusion on the inner surface of toe arise. This study aimed to determine the effect of botulinum toxin A injection to reduce pain and deviation angle of the thumb in Hallux Valgus and to increase outcomes of treatment as an adjuvant therapy. Randomized clinical study was performed on 18 patients at the Clinic of Physical Medicine and Rehabilitation, Isfahan University of Medical Sciences. In this study the Halgvs valgus angle (HVA) between the metatarsals (IMA) and cartilage distal metatarsal angle (DMAA) and pain were assessed before and after injection. Average of Hallux Valgus angle before and after Botox injections were 28/89 ± 10/21 and 21/56 ± 8/22 degrees and the angle deviation in the 6 months after treatment was significantly improved (p <0.001). Injection of botulinum toxin A is a suitable and acceptable method to reform the skeleton deformities and also to reduce the pain in patients with Hallux valgus.

Keywords: metatasal, hallux valgus, pain, botulinum toxuin

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Authors: K. B. Chathyushya, M. Shiva Prakash, R. Hemalatha

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Introduction: Gastrointestinal (GI) tract has a number of microorganisms (microbiota) that influences the host’s health. The imbalance in the gut microbiota, which is also called as gut dysbiosis, affects human health which causes various metabolic, inflammatory, and infectious diseases. Probiotics play an important role in reinstating the gut balance. Probiotics are involved in the maintenance of healthier gut microbiota and have also been identified as effective adjuvants in insulin resistance therapies. Methods: This paper systematically reviews different randomized, controlled, blinded trials of probiotics for the treatment of various diseases along with the therapeutic or prophylactic properties of probiotic bacteria in different metabolic, inflammatory, infectious and anxiety-related disorders. Conclusion: The present review summarises that probiotics have some considerable effect in the management of various diseases, however, the benefits are strain specific, although more clinical trials are need to be carried out with different probiotic and symbiotic combinations as some probiotics have broad spectrum of benefits and few with specific activity

Keywords: life style diseases, cognition, health, gut dysbiosis, probiotics

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Authors: Zainab Shaikh, Yusuf Miyanji

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Pilomatrixoma is a benign neoplasm of the hair follicle matrix that is not commonly diagnosed in general practice. This is a case report of a 9-year-old boy who presented with a one-year history of a 19mm x 11 mm swelling in the left infra-orbital region. This was previously undiagnosed in Spain, where the patient resided at the time of initial presentation, due to the language barrier the patient’s family encountered. An ultrasound and magnetic resonance imaging gave useful information regarding surrounding structures for complete tumor excision and indicated that the risk of facial nerve palsy is low. The lesion was surgically excised and a definitive diagnosis was made after histopathology. Pilomatrixoma, although not rare in its occurrence, is rarely this large at the time of excision due to early presentation. This case highlights the importance of including pilomatrixoma in the differential diagnosis of dermal and subcutaneous lesions in the head and neck region, as it is often misdiagnosed due to the lack of awareness of its clinical presentation.

Keywords: pilomatrixoma, swelling, infra-orbital, facial swelling

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Authors: Rasime Kalkan, Emine Ikbal Atli, Ali Arslantaş, Muhsin Özdemir, Sevilhan Artan

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Glioblastoma (WHO grade IV), is the malignant form of brain tumor, the genetic background of the GBM is highly variable. The tumor mass of a GBM is multilayered and every tumor layer shows distinct characteristics with a different cell population. The treatment planning of GBM should be focused on the tumor genetic characteristics. We screened primary glioblastoma multiforme (GBM) in a population-based study for MGMT and RARβ methylation and IDH1 mutation correlated them with clinical data and treatment. There was no correlation between MGMT-promoter methylation and overall survival. The overall survival time of the patients with methylated RARβ was statically (OS;p<0,05) significance between the patients who were treated with chemotherapy and radiotherapy. Here we showed the status of IDH1 gene associatied with younger age. We demonstrated that the together with MGMT gene the RARβ gene should be used as a potantial treatment decision marker for GBMs.

Keywords: RARβ, primary glioblastoma multiforme, methylation, MGMT

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Authors: P. Karpagam, Babu Joseph, P. Ashok Kumar

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The incidence of Candida infections is increasing worldwide. The serious nature of these infections is compounded by increasing levels of drug resistance. Pure cultures of the Candida sp. were obtained from clinical isolates and fresh garlic extracts were obtained by extraction techniques. The antifungal activity of garlic extract was investigated in an in vitro system. The extract (100%, 75% and 50%) showed significant antifungal activity against Candida, whereas, low concentration (25%) of the extract showed less antifungal activity against the test organism. Antifungal activities of honey and lemon juice were tested against the Candida; however, the growth was not inhibited by these extracts. On the other hand honey and lemon when combined with garlic exhibited a good antifungal activity. The study thus confirms the antifungal properties of garlic extract along with additives like honey and lemon have significant antifungal activity against isolates of Candida species.

Keywords: Candida, garlic extract, lemon, synergitic antifungal activity

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Authors: Vijayalakshmi Marella, NageswaraRaoPilli

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This paper describes a simple, rapid and sensitive liquid chromatography / tandem mass spectrometry assay for the determination of montelukast in human plasma using montelukast d6 as an internal standard. Analyte and the internal standard were extracted from 50 µL of human plasma via solid phase extraction technique without evaporation, drying and reconstitution steps. The chromatographic separation was achieved on a C18 column by using a mixture of methanol and 5mM ammonium acetate (80:20, v/v) as the mobile phase at a flow rate of 0.8 mL/min. Good linearity results were obtained during the entire course of validation. Method validation was performed as per FDA guidelines and the results met the acceptance criteria. A run time of 2.5 min for each sample made it possible to analyze more number of samples in short time, thus increasing the productivity. The proposed method was found to be applicable to clinical studies.

Keywords: Montelukast, tandem mass spectrometry, montelukast d6, FDA guidelines

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