Search results for: clinical syndrome

Authors: Ragy Raafat Gaber Attaalla

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For cardiovascular illness, oral P2Y12 inhibitors including clopidogrel, prasugrel, and ticagrelor are frequently recommended. Each of these medications has advantages and disadvantages. In the absence of genotyping, it has been demonstrated that the stronger platelet aggregation inhibitors prasugrel and ticagrelor are superior than clopidogrel at preventing significant adverse cardiovascular events following an acute coronary syndrome and percutaneous coronary intervention (PCI). Both, nevertheless, come with a higher risk of bleeding unrelated to a coronary artery bypass. As a prodrug, clopidogrel needs to be bioactivated, principally by the CYP2C19 enzyme. A CYP2C19 no function allele and diminished or absent CYP2C19 enzyme activity are present in about 30% of people. The reduced exposure to the active metabolite of clopidogrel and reduced inhibition of platelet aggregation among clopidogrel-treated carriers of a CYP2C19 no function allele likely contributed to the reduced efficacy of clopidogrel in clinical trials. Clopidogrel's pharmacogenetic results are strongest when used in conjunction with PCI, but evidence for other indications is growing. One of the most typical examples of clinical pharmacogenetic application is CYP2C19 genotype-guided antiplatelet medication following PCI. Guidance is available from expert consensus groups and regulatory bodies to assist with incorporating genetic information into P2Y12 inhibitor prescribing decisions. Here, we examine the data supporting genotype-guided P2Y12 inhibitor selection's effects on clopidogrel response and outcomes and discuss tips for pharmacogenetic implementation. We also discuss procedures for using genotype data to choose P2Y12 inhibitor therapies as well as any unmet research needs. Finally, choosing a P2Y12 inhibitor medication that optimally balances the atherothrombotic and bleeding risks may be influenced by both clinical and genetic factors.

Keywords: inhibitors, cardiovascular events, coronary intervention, pharmacogenetic implementation

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Authors: N. C. van der Merwe, J. Oosthuizen, M. F. Makhetha, J. Adams, B. K. Dajee, S-R. Schneider

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Women representing high-risk breast cancer families, who tested negative for pathogenic mutations in BRCA1 and BRCA2, are four times more likely to develop breast cancer compared to women in the general population. Sequencing of genes involved in genomic stability and DNA repair led to the identification of novel contributors to familial breast cancer risk. These include BLM and PALB2. Bloom's syndrome is a rare homozygous autosomal recessive chromosomal instability disorder with a high incidence of various types of neoplasia and is associated with breast cancer when in a heterozygous state. PALB2, on the other hand, binds to BRCA2 and together, they partake actively in DNA damage repair. Archived DNA samples of 66 BRCA1/2 negative high-risk breast cancer patients were retrospectively selected based on the presence of an extensive family history of the disease ( > 3 affecteds per family). All coding regions and splice-site boundaries of both genes were screened using High-Resolution Melting Analysis. Samples exhibiting variation were bi-directionally automated Sanger sequenced. The clinical significance of each variant was assessed using various in silico and splice site prediction algorithms. Comprehensive screening identified a total of 11 BLM and 26 PALB2 variants. The variants detected ranged from global to rare and included three novel mutations. Three BLM and two PALB2 likely pathogenic mutations were identified that could account for the disease in these extensive breast cancer families in the absence of BRCA mutations (BLM c.11T > A, p.V4D; BLM c.2603C > T, p.P868L; BLM c.3961G > A, p.V1321I; PALB2 c.421C > T, p.Gln141Ter; PALB2 c.508A > T, p.Arg170Ter). Conclusion: The study confirmed the contribution of pathogenic mutations in BLM and PALB2 to the familial breast cancer burden in South Africa. It explained the presence of the disease in 7.5% of the BRCA1/2 negative families with an extensive family history of breast cancer. Segregation analysis will be performed to confirm the clinical impact of these mutations for each of these families. These results justify the inclusion of both these genes in a comprehensive breast and ovarian next generation sequencing cancer panel and should be screened simultaneously with BRCA1 and BRCA2 as it might explain a significant percentage of familial breast and ovarian cancer in South Africa.

Keywords: Bloom Syndrome, familial breast cancer, PALB2, South Africa

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Authors: Md, MCS, MPH Munyangi Wa Nkola Jerome

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The pandemic of COVID-19, a recently discovered contagious respiratory disease called SARS-CoV-2 (Severe Acute Respiratory Syndrome-Coronavirus 2 Majority of people infected with SARS-CoV-2: Asymptomatic or mildly ill 14% of patients will develop severe illness requiring hospitalization and oxygen support, and 5% of these will be transferred to an intensive care unit, Urgent need for new treatments that can be used quickly to avoid transfer of patients to intensive care and death. Objective: To evaluate the clinical activity (efficacy) of ArtiCovid Hypothesis: Administration of 3 times a teaspoon per day by COVID patients (symptomatic, mild, or moderate forms) results in the disappearance of symptoms and improvement of biological parameters (including viral suppression). Clinical efficacy: the disappearance of clinical signs after seven days of treatment; reduction in the rate of patients transferred to intensive care units for mechanical ventilation and a decrease in mortality related to this infection Paraclinical efficacy: improvement of biological parameters (mainly d-dimer, CRP) Virological efficacy: suppression of the viral load after seven days of treatment (control test on the seventh day is negative) Pilot study using a standardized solution based on Artemisia annua (ARTICOVID) Obtaining authorization from the health authorities of the province of Central Kongo Recruitment of volunteer patients, mainly in the Kinkanda HospitalCarrying out tests before and after treatment as well as analyses before and after treatment. The protocol obtained the approval of the ethics committee 50 patients who completed the treatment were aged between 2 and 70 years, with an average age of 36 yearsMore half were male (56%). One in four patients was a health professional (25%) Of the 12 health professionals, 4 were physicians. For those who reported the date of onset of the disease, the average duration between the appearance of the first symptoms and the medical consultation was 5 days. The 50 patients put on ARTICOVID were discharged alive with CRP levels substantially normalizedAfter seven to eight days, the control test came back negative. This pilot study suggests that ARTICOVID may be effective against COVID-19 infection.

Keywords: artiCovid, DRC, Covid-19, SARS_COV_2

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Authors: Arjun Prakash, Vinutha H., Karthik N.

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BACKGROUND: Carpal tunnel syndrome (CTS) is a common entrapment neuropathy with an estimated prevalence of 0.6 - 5.8% in the general adult population. It is caused by compression of the Median Nerve (MN) at the wrist as it passes through a narrow osteofibrous canal. Presently, the diagnosis is established by the clinical symptoms and physical examination and Nerve conduction study (NCS) is used to assess its severity. However, it is considered to be painful, time consuming and expensive, with a false-negative rate between 16 - 34%. Ultrasonography (USG) is now increasingly used as a diagnostic tool in CTS due to its non-invasive nature, increased accessibility and relatively low cost. Elastography is a newer modality in USG which helps to assess stiffness of tissues. However, there is limited available literature about its applications in peripheral nerves. OBJECTIVES: Our objectives were to measure the Cross-Sectional Area (CSA) and elasticity of MN at the carpal tunnel using Grey scale Ultrasonography (USG), Strain Elastography (SE) and Shear Wave Elastography (SWE). We also made an attempt to independently evaluate the role of Gray scale USG, SE and SWE in grading the severity of CTS, keeping NCS as the gold standard. MATERIALS AND METHODS: After approval from the Institutional Ethics Review Board, we conducted a comparative cross sectional study for a period of 18 months. The participants were divided into two groups. Group A consisted of 54 patients with clinically diagnosed CTS who underwent NCS, and Group B consisted of 50 controls without any clinical symptoms of CTS. All Ultrasound examinations were performed on SAMSUNG RS 80 EVO Ultrasound machine with 2 - 9 Mega Hertz linear probe. In both groups, CSA of the MN was measured on Grey scale USG, and its elasticity was measured at the carpal tunnel (in terms of Strain ratio and Shear Modulus). The variables were compared between both groups by using ‘Independent t test’, and subgroup analyses were performed using one-way analysis of variance. Receiver operating characteristic curves were used to evaluate the diagnostic performance of each variable. RESULTS: The mean CSA of the MN was 13.60 + 3.201 mm2 and 9.17 + 1.665 mm2 in Group A and Group B, respectively (p < 0.001). The mean SWE was 30.65 + 12.996 kPa and 17.33 + 2.919 kPa in Group A and Group B, respectively (p < 0.001), and the mean Strain ratio was 7.545 + 2.017 and 5.802 + 1.153 in Group A and Group B respectively (p < 0.001). CONCLUSION: The combined use of Gray scale USG, SE and SWE is extremely useful in grading the severity of CTS and can be used as a painless and cost-effective alternative to NCS. Early diagnosis and grading of CTS and effective treatment is essential to avoid permanent nerve damage and functional disability.

Keywords: carpal tunnel, ultrasound, elastography, nerve conduction study

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Authors: Mihai-Ionut Firescu, Mark A. P. Carson

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We present a case of inferior vena cava agenesis (IVCA) associated with bilateral deep venous thrombosis (DVT) in a patient with Beckwith-Wiedemann syndrome (BWS). In adult patients with BWS presenting with bilateral lower limb oedema, specific aetiological factors should be considered. These include cardiomyopathy and intraabdominal tumours. Congenital malformations of the IVC, through causing relative venous stasis, can lead to lower limb oedema either directly or indirectly by favouring lower limb venous thromboembolism; however, they are yet to be reported as an associated feature of BWS. Given its life-threatening potential, the prompt initiation of treatment for bilateral DVT is paramount. In BWS patients, however, this can prove more complicated. Due to overgrowth, the above-average birth weight can continue throughout childhood. In this case, the patient’s weight reached 170 kg, impacting on anticoagulation choice, as direct oral anticoagulants have a limited evidence base in patients with a body mass above 120 kg. Furthermore, the presence of IVCA leads to a long-term increased venous thrombosis risk. Therefore, patients with IVCA and bilateral DVT warrant specialist consideration and may benefit from multidisciplinary team management, with hematology and vascular surgery input. Conclusion: Here, we showcased a rare cause for bilateral lower limb oedema, respectively bilateral deep venous thrombosis complicating IVCA in a patient with Beckwith-Wiedemann syndrome. The importance of this case lies in its novelty, as the association between IVC agenesis and BWS has not yet been described. Furthermore, the treatment of DVT in such situations requires special consideration, taking into account the patient’s weight and the presence of a significant, predisposing vascular abnormality.

Keywords: Beckwith-Wiedemann syndrome, bilateral deep venous thrombosis, inferior vena cava agenesis, venous thromboembolism

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Authors: Maria Monica D. Espinosa

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This study aimed to identify and examine the characteristics of an effective leader in a Hospital institution from the perspectives of military nurse-managers. The researcher extracted the different facets of leadership from the stories of six nurse- managers from a military hospital. The stories which are in pre-reflective stage convey an unbiased perspective from which clinical leadership may be defined. Using Phenomenology as a method of Research, the lived experiences of the military nurse-managers served as empirical data which were reflected upon until the formulation of insights. The information from the co-researchers became gallows from which the characteristics of effective leadership in the clinical area were drawn. These insights were synthesized through layers of reflection that resulted to the knowledge about clinical leadership. The reflections are the following, (a) Clinical leaders develop their skills through experiences and hardwork; (b) Clinical leaders are devoted; (c) Clinical leaders are focused; (d) Clinical leaders are good in interpersonal relationship; (e) Clinical leaders are mentors; (f) Clinical leaders seek affirmation and recognition; and (g) Clinical leaders are responsible and dependable. The common themes that emerged from the nurse manager’s stories showed that clinical leadership maybe attained if leaders possessed the following traits, (a) The gift to establish a steadfast and firm management; (b) The proficiency to guide and encourage others towards the achievement of their goals and objectives; (c) The ability to instigate participative and collaborative work among his/her subordinates and (d) The aptitude and skill to address the institutional concerns in their unit. In the future, Clinical leaders should continually adapt an evaluation program on how they can relate socially with their subordinates, the result of which can be used as a basis in developing strategies on relationship enhancement. Moreover, they should empower the nurses by allowing them to voice out their opinions and concerns regarding assignments, role expectations, and workload issues to improve and strengthen the relationships among nurses. Lastly, they can incorporate a collaborative strategy to promote professional socialization attitudes of nurse managers who work with staff nurses to improve the quality of their proficiencies and enhance a positive clinical environment.

Keywords: clinical leadership, experiences, implications, military nurse - managers, phenomenology

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Authors: Bita Rabbani, Hossein Chiti, Faranak Sharifi, Saeedeh Mazloomzadeh

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Background: Lifestyle modifications, especially improving nutritional patterns and increasing physical activity, are the most important factors in preventing obesity and metabolic syndrome in children and adolescents. For this purpose, the following interventional study was designed to investigate the effects of educational programs for students, as well as changes in diet and physical activity, on obesity and components of the metabolic syndrome. Methods: This study is part of an interventional research project (elementary school) conducted on all students of Sama schools in Zanjan and Abhar in three levels of elementary, middle, and high school, including 1000 individuals in Zanjan (intervention group) and 1000 individuals (control group) in Abhar in 2011. Interventions were based on educating students, teachers, and parents, changes in food services, and physical activity. We primarily measured anthropometric indices, fasting blood sugar, lipid profiles, and blood pressure and completed standard nutrition and physical activity questionnaires. Also, blood insulin levels were randomly measured in a number of students. Data analysis was done by SPSS software version 16.0. Results: Overall, 589 individuals (252 male, 337 female) entered the case group, and 803 individuals (344 male, 459 female) entered the control group. After two years of intervention, mean waist circumference (63.8 ± 10.9) and diastolic BP (63.8 ± 10.4) were significantly lower; however, mean systolic BP (10.1.0 ± 12.5), food score (25.0 ± 5.0) and drinking score (12.1 ± 2.3) were higher in the intervention group (p<0.001). Comparing components of metabolic syndrome between the second year and at time of recruitment within the intervention group showed that although number of overweight/obese individuals, individuals with hypertriglyceridemia and high LDL increased, abdominal obesity, high BP, hyperglycemia, and insulin resistance decreased (p<0.001). On the other hand, in the control group, number of individuals with high BP increased significantly. Conclusion: The prevalence of abdominal obesity and hypertension, which are two major components of metabolic syndrome, are much higher in our study than in other regions of country. However, interventions for modification of diet and increase in physical activity are effective in lowering their prevalence.

Keywords: metabolic syndrome, obesity, life style, nutrition, hypertension

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Authors: Sarah Sayed El- Tawab, Emmanuel Kamal Azix Saba

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Objectives: Somatosensory blink reflex (SBR) is an eye blink response obtained from electrical stimulation of peripheral nerves or skin area of the body. It has been studied in various neurological diseases as well as among healthy subjects in different population. We designed this study to detect SBR positivity in patients with facial palsy and patients with post facial syndrome, to relate the facial palsy severity and the presence of SBR, and to associate between trigeminal BR changes and SBR positivity in peripheral facial palsy patients. Methods: 50 patients with peripheral facial palsy and post-facial syndrome 31 age and gender matched healthy volunteers were enrolled to this study. Facial motor conduction studies, trigeminal BR, and SBR were studied in all. Results: SBR was elicited in 67.7% of normal subjects, in 68% of PFS group, and in 32% of PFP group. On the non-paralytic side SBR was found in 28% by paralyzed side stimulation and in 24% by healthy side stimulation among PFP patients. For PFS group SBR was found on the non- paralytic side in 48%. Bilateral SBR elicitability was higher than its unilateral elicitability. Conclusion: Increased brainstem interneurons excitability is not essential to generate SBR. The hypothetical sensory-motor gating mechanism is responsible for SBR generation.

Keywords: somatosensory evoked blink reflex, post facial syndrome, blink reflex, enchanced gain

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Authors: C. Bel, J. Nevado, F. Ciceri, M. Ropacki, T. Hoffmann, P. Lapunzina, C. Buesa

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Background: The Phelan-McDermid syndrome (PMS) is a genetic disorder caused by the deletion of the terminal region of chromosome 22 or mutation of the SHANK3 gene. Shank3 disruption in mice leads to dysfunction of synaptic transmission, which can be restored by epigenetic regulation with both Lysine Specific Demethylase 1 (LSD1) inhibitors. PMS subjects result in a variable degree of intellectual disability, delay or absence of speech, autistic spectrum disorders symptoms, low muscle tone, motor delays and epilepsy. Vafidemstat is an LSD1 inhibitor in Phase II clinical development with a well-established and favorable safety profile, and data supporting the restoration of memory and cognition defects as well as reduction of agitation and aggression in several animal models and clinical studies. Therefore, vafidemstat has the potential to become a first-in-class precision medicine approach to treat PMS patients. Aims: The goal of this research is to perform an observational trial to psychometrically characterize individuals carrying deletions in SHANK3 and build a foundation for subsequent precision psychiatry clinical trials with vafidemstat. Methodology: This study is characterizing the clinical profile of 20 to 40 subjects, > 16-year-old, with genotypically confirmed PMS diagnosis. Subjects will complete a battery of neuropsychological scales, including the Repetitive Behavior Questionnaire (RBQ), Vineland Adaptive Behavior Scales, Escala de Observación para el Diagnostico del Autismo (Autism Diagnostic Observational Scale) (ADOS)-2, the Battelle Developmental Inventory and the Behavior Problems Inventory (BPI). Results: By March 2021, 19 patients have been enrolled. Unsupervised hierarchical clustering of the results obtained so far identifies 3 groups of patients, characterized by different profiles of cognitive and behavioral scores. The first cluster is characterized by low Battelle age, high ADOS and low Vineland, RBQ and BPI scores. Low Vineland, RBQ and BPI scores are also detected in the second cluster, which in contrast has high Battelle age and low ADOS scores. The third cluster is somewhat in the middle for the Battelle, Vineland and ADOS scores while displaying the highest levels of aggression (high BPI) and repeated behaviors (high RBQ). In line with the observation that female patients are generally affected by milder forms of autistic symptoms, no male patients are present in the second cluster. Dividing the results by gender highlights that male patients in the third cluster are characterized by a higher frequency of aggression, whereas female patients from the same cluster display a tendency toward higher repetitive behavior. Finally, statistically significant differences in deletion sizes are detected comparing the three clusters (also after correcting for gender), and deletion size appears to be positively correlated with ADOS and negatively correlated with Vineland A and C scores. No correlation is detected between deletion size and the BPI and RBQ scores. Conclusions: Precision medicine may open a new way to understand and treat Central Nervous System disorders. Epigenetic dysregulation has been proposed to be an important mechanism in the pathogenesis of schizophrenia and autism. Vafidemstat holds exciting therapeutic potential in PMS, and this study will provide data regarding the optimal endpoints for a future clinical study to explore vafidemstat ability to treat shank3-associated psychiatric disorders.

Keywords: autism, epigenetics, LSD1, personalized medicine

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Authors: Nadeem Bashir, Ghulam Mustafa Peerzada

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The present study pertains to the nonlinear behavior of acetaminophen based uncatalyzed Belousov-Zhabotinsky (BZ) oscillator and its dynamics in the presence of Ferroin as the catalyst. The role of free metal ions as catalysts was examined and the results compared with corresponding complexed catalysts. Free metal ions were found to be sluggish with respect to the evolution of the oscillatory regime as compared to complexed ones. Effect of change of the ligand moiety of the catalyst complex on the oscillatory parameters was monitored. Since ethanol potentiates the hepatotoxicity caused by acetaminophen in-vivo, it is thought to understand this interaction by virtue of causing perturbation of the acetaminophen based oscillator with different concentrations of the ethanol with and without ferroin as the catalyst. Another dimension to the ethanol effect was added by perturbation of the system with ethanol at different stages of the reaction so as to get an idea whether it is acetaminophen or some reactive intermediate generated in the reaction system which reacts with ethanol. Further, the ferroin-catalyzed oscillator is taken as a prototype inorganic model of the acetaminophen-ethanol syndrome, as ferroin and HOBr were inorganic replacements to Cyt P450 and NADPH in the alcohol metabolism.

Keywords: Belousov-Zhabotinsky reaction, ferroin, Paracetamol-Ethanol syndrome, kinetics

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Authors: A. Lubis, R. Widayanti, Z. Hikmah, A. Endaryanto, A. Harsono, A. Harianto, R. Etika, D. K. Handayani, M. Sampurna

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Neonatal lupus erythematous (NLE) is a rare disease marked by clinical characteristic and specific maternal autoantibody. Many cutaneous, cardiac, liver, and hematological manifestations could happen with affect of one organ or multiple. In this case, both babies were premature, low birth weight (LBW), small for gestational age (SGA) and born through caesarean section from a systemic lupus erythematous (SLE) mother. In the first case, we found a baby girl with dyspnea and grunting. Chest X ray showed respiratory distress syndrome (RDS) great I and echocardiography showed small atrial septal defect (ASD) and ventricular septal defect (VSD). She also developed anemia, thrombocytopenia, elevated C-reactive protein, hypoalbuminemia, increasing coagulation factors, hyperbilirubinemia, and positive blood culture of Klebsiella pneumonia. Anti-Ro/SSA and Anti-nRNP/sm were positive. Intravenous fluid, antibiotic, transfusion of blood, thrombocyte concentrate, and fresh frozen plasma were given. The second baby, male presented with necrotic tissue on the left ear and skin rashes, erythematous macula, athropic scarring, hyperpigmentation on all of his body with various size and facial haemorrhage. He also suffered from thrombocytopenia, mild elevated transaminase enzyme, hyperbilirubinemia, anti-Ro/SSA was positive. Intravenous fluid, methyprednisolone, intravenous immunoglobulin (IVIG), blood, and thrombocyte concentrate transfution were given. Two cases of neonatal lupus erythematous had been presented. Diagnosis based on clinical presentation and maternal auto antibody on neonate. Organ involvement in NLE can occur as single or multiple manifestations.

Keywords: neonatus lupus erythematous, maternal autoantibody, clinical characteristic, multiple organ manifestation

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Authors: Junaid Mahmood Alam, Sana Anwar, Sarah Sughra Asghar

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Chronic hepatitis or Hepatitis C viral (HCV) infection has been identified as one of the factors that could elicit autoimmune disease resulting in the development of auto-antibodies. Furthermore, HCV is implicated in contravening of forbearance to antigens, therefore, inciting auto-reactivity. In this regard, several near and past studies noted the prevalence of thyroid dysfunction and production of anti-thyroid antibodies (ATAb) such as anti-thyroid peroxidase (AntiTPO) and anti-thyroglobulin (AntiTG) in patients with HCV. Likewise, one of the etiologies of augmentation of thyroid disease is basically interferon therapy for HCV infections, for which a number of autoimmune diseases have been noted including Grave’s disease, Hishimoto thyroiditis. A prospectively case-control study was therefore carried out at department of clinical biochemistry lab services and chemical pathology in collaboration with department of clinical microbiology, at Liaquat National Hospital and Medical College, Karachi Pakistan for the period January 2015 to December 2017. Two control groups were inducted for comparison purpose, control group 1 = without HCV infection and with thyroid disorders (n = 20), control group 2 = with HCV infection and without thyroid disorders (n = 20), whereas HCV infected were n = 40 where more than half were noted to be positive for either of HCV IgG and Ag. In HCV group, patients with existing sub-clinical hypothyroidism and clinical hyperthyroidism were less than 5%. Analysis showed the presence of AntiTG in 12 HCV patients (30%), AntiTPO in 15 (37.5%) and both AntiTG and antiTPO in 10 patients (25%). Only 3 patients were found with the history of anti-thyroid auto-antibodies (7.5%) and one with parents and relatives with auto-immune disorders (2.5%). Patients that remained untreated were 12 (30%), under treatment 18 (45%) and with complete-course of treatment 10 (25%). As per review of the literature, meta-analysis of evident data and cross-sectional studies of selective cohorts (as studied in presented research), thyroid connection is designated as one of the most recurrent endocrine ailment associated with chronic HCV infection. Moreover, it also represents an extrahepatic disease in the continuum of HCV syndrome. In conclusion, HCV patients were more likely to encompass thyroid disorders especially related to development of either of ATAb or both antiTG and AntiTPO.

Keywords: Hepatitis C viral (HCV) infection, anti-thyroid antibodies, anti-thyroid peroxidase antibodies, anti-thyroglobulin antibodies

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Authors: Ramy Shaaban

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The purpose of this study was to examine the difference in clinical reasoning skills of students when using virtual audiology cases with and without collaborative assistance from major learning approaches important to clinical reasoning skills and computer-based learning models: Situated Learning Theory, Social Development Theory, Scaffolding, and Collaborative Learning. A quasi-experimental design was conducted at two United States universities to examine whether there is a significant difference in clinical reasoning skills between three treatment groups using IUP Audiosim software. Two computer-based audiology case simulations were developed, and participants were randomly placed into the three groups: no collaboration, virtual collaboration, and live collaboration. The clinical reasoning data were analyzed using One-Way ANOVA and Tukey posthoc analyses. The results show that there was a significant difference in clinical reasoning skills between the three treatment groups. The score obtained by the no collaboration group was significantly less than the scores obtained by the virtual and live collaboration groups. Collaboration, whether virtual or in person, has a positive effect on students’ clinical reasoning. These results with audiology students indicate that combining collaboration models with scaffolding and embedding situated learning and social development theories into the design of future virtual patients has the potential to improve students’ clinical reasoning skills.

Keywords: clinical reasoning, virtual patients, collaborative learning, scaffolding

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Authors: Sheeraz Memon, Namunu C. Maddage, Margaret Lech, Nicholas Allen

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The effect of a clinical environment on the accuracy of the speaker verification was tested. The speaker verification tests were performed within homogeneous environments containing clinically depressed speakers only, and non-depresses speakers only, as well as within mixed environments containing different mixtures of both climatically depressed and non-depressed speakers. The speaker verification framework included the MFCCs features and the GMM modeling and classification method. The speaker verification experiments within homogeneous environments showed 5.1% increase of the EER within the clinically depressed environment when compared to the non-depressed environment. It indicated that the clinical depression increases the intra-speaker variability and makes the speaker verification task more challenging. Experiments with mixed environments indicated that the increase of the percentage of the depressed individuals within a mixed environment increases the speaker verification equal error rates.

Keywords: speaker verification, GMM, EM, clinical environment, clinical depression

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Authors: Tugba Sevinc Gamsiz, Emine Koroglu, Ozcan Keskin

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Aim: Nonalcoholic fatty liver disease (NAFLD) is considered the most common chronic liver disease in the general population. The higher mortality and morbidity among NAFLD patients and lack of symptoms makes early detection and management important. In our study, we aimed to evaluate the relationship between noninvasive imaging and biochemical markers in diabetic and nondiabetic patients diagnosed with NAFLD. Materials and Methods: The study was conducted from (September 2017) to (December 2017) on adults admitted to Internal Medicine and Gastroenterology outpatient clinics with hepatic steatosis reported on ultrasound or transient elastography within the last six months that exclude patients with other liver diseases or alcohol abuse. The data were collected and analyzed retrospectively. Number cruncher statistical system (NCSS) 2007 program was used for statistical analysis. Results: 116 patients were included in this study. Diabetic patients compared to nondiabetics had significantly higher Controlled Attenuation Parameter (CAP), Liver Stiffness Measurement (LSM) and fibrosis values. Also, hypertension, hepatomegaly, high BMI, hypertriglyceridemia, hyperglycemia, high A1c, and hyperuricemia were found to be risk factors for NAFLD progression to fibrosis. Advanced fibrosis (F3, F4) was present in 18,6 % of all our patients; 35,8 % of diabetic and 5,7 % of nondiabetic patients diagnosed with hepatic steatosis. Conclusion: Transient elastography is now used in daily clinical practice as an accurate noninvasive tool during follow-up of patients with fatty liver. Early diagnosis of the stage of liver fibrosis improves the monitoring and management of patients, especially in those with metabolic syndrome criteria.

Keywords: diabetes, elastography, fatty liver, fibrosis, metabolic syndrome

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Authors: Luca Martignoni

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The increasing usage of clinical decision support systems in healthcare and the demand for software that enables doctors to take informed decisions is changing everyday clinical practice. However, as technology advances not only are the benefits of technology growing, but so are the potential risks. A growing danger is the doctors’ over-reliance on the proposed decision of the clinical decision support system, leading towards deskilling and rash decisions by doctors. In that regard, identifying doctors' requirements for software and developing approaches to prevent technological over-reliance is of utmost importance. In this paper, we report the results of a design science research study, focusing on the requirements and design principles of ultrasound software. We conducted a total of 15 interviews with experts about poten-tial ultrasound software functions. Subsequently, we developed meta-requirements and design principles to design future clinical decision support systems efficiently and as free from the occur-rence of technological over-reliance as possible.

Keywords: clinical decision support systems, technological over-reliance, design principles, design science research

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Authors: Kuni Vergauwen, Ivan P. J. Huijnen, Astrid Depuydt, Jasmine Van Regenmortel, Mira Meeus

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A lower activity level and imbalanced activity pattern are frequently observed in persons with chronic fatigue syndrome (CFS) / myalgic encephalomyelitis (ME) due to debilitating fatigue and post-exertional malaise (PEM). Identification of measurement instruments to evaluate the activity level and pattern is therefore important. The objective is to identify measurement instruments suited to evaluate the activity level and/or pattern in patients with CFS/ME and review their psychometric properties. A systematic literature search was performed in the electronic databases PubMed and Web of Science until 12 October 2016. Articles including relevant measurement instruments were identified and included for further analysis. The psychometric properties of relevant measurement instruments were extracted from the included articles and rated based on the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. The review was performed and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. A total of 49 articles and 15 unique measurement instruments were found, but only three instruments were evaluated in patients with CFS/ME: the Chronic Fatigue Syndrome-Activity Questionnaire (CFS-AQ), Activity Pattern Interview (API) and International Physical Activity Questionnaire-Short Form (IPAQ-SF), three self-report instruments measuring the physical activity level. The IPAQ-SF, CFS-AQ and API are all equally capable of evaluating the physical activity level, but none of the three measurement instruments are optimal to use. No studies about the psychometric properties of activity monitors in patients with CFS/ME were found, although they are often used as the gold standard to measure the physical activity pattern. More research is needed to evaluate the psychometric properties of existing instruments, including the use of activity monitors.

Keywords: chronic fatigue syndrome, data collection, physical activity, psychometrics

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Authors: Mamdouh Milad Adly Morkos

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Despite having the greatest rates of mortality and morbidity in the world, low- and middle-income (LMIC) nations trail high-income nations in terms of the number of clinical trials, the number of qualified researchers, and the amount of research information specific to their people. Health inequities and the use of precision medicine may be hampered by a lack of local genomic data, clinical pharmacology and pharmacometrics competence, and training opportunities. These issues can be solved by carrying out health care infrastructure development, which includes data gathering and well-designed clinical pharmacology training in LMICs. It will be advantageous if there is international cooperation focused at enhancing education and infrastructure and promoting locally motivated clinical trials and research. This paper outlines various instances where clinical pharmacology knowledge could be put to use, including pharmacogenomic opportunities that could lead to better clinical guideline recommendations. Examples of how clinical pharmacology training can be successfully implemented in LMICs are also provided, including clinical pharmacology and pharmacometrics training programmes in Africa and a Tanzanian researcher's personal experience while on a training sabbatical in the United States. These training initiatives will profit from advocacy for clinical pharmacologists' employment prospects and career development pathways, which are gradually becoming acknowledged and established in LMICs. The advancement of training and research infrastructure to increase clinical pharmacologists' knowledge in LMICs would be extremely beneficial because they have a significant role to play in global health

Keywords: electromagnetic solar system, nano-material, nano pharmacology, pharmacovigilance, quantum theoryclinical simulation, education, pharmacology, simulation, virtual learning low- and middle-income, clinical pharmacology, pharmacometrics, career development pathways

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Authors: Ibrahim Abouelkhir

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Background: Prior to this project, the number of CT aorta requests from our Emergency Department (ED) was reported by the radiology department to be high with a low positive event rate: only 1- 2% of CT aortas performed were positive for acute aortic syndrome. This trend raised concerns about the time required to process and report these scans, potentially impacting the timely reporting of other high-priority imaging, such as trauma-related scans. Other harms identified were unnecessary radiation, patients spending longer in ED contributing to overcrowding, and, most importantly, the patient not getting the right care the first time. The radiology department also raised the problem of reporting bias because they expected our CT aortas to be normal. Aim: The main aim of this project was to reduce the number of unnecessary CT aortas requested, which would be shown by 1. Number of CT aortas requested and 2. Positive event rate. Methodology: This was a quality improvement project carried out in the ED at Frimley Park Hospital, UK. Starting from 1 st January 2024, we recorded the number of days required to reach 35 CT aorta requests. We looked at all patients presenting to the ED over the age of 16 for whom a CT aorta was requested by the ED team. We looked at how many of these scans were positive for acute aortic syndrome. The intervention was a change in practice: all CT aortas should be approved by an ED consultant or ST4+ registrar (5th April 2024). We then reviewed the number of days it took to reach a total of 35 CT aorta requests following the intervention and again reviewed how many were positive. Results: Prior to the intervention, 35 CT Aorta scans were performed over a 20-day period. Following the implementation of the ED senior doctor vetting process, the same number of CT Aorta scan requests was observed over 50 days - more than twice the pre-intervention period. This indicates a significant reduction in the rate of CT Aorta scans being requested. During the pre-intervention phase, there were two positive cases of acute aortic syndrome. In the post-intervention period, there were zero. Conclusion: The mandatory review of CT Aorta scan requested by the ED consultant effectively reduced the number of scans requested. However, this intervention did not lead to an increase in positive scan results. We noted that post-intervention, approximately 50% of scans had been approved by registrar-grade doctors and, only 50% had been approved by ED consultants, and the majority were not in-person reviews. We wonder if restricting the approval to consultant grade only might improve the results, and furthermore, in person reviews should be the gold standard.

Keywords: quality improvement project, CT aorta scans, emergency department, radiology department, aortic dissection, scan request vetting, clinical outcomes, imaging efficiency

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Authors: Tuong Thi Van Thuy, Dao Van Toan, Nguyen Duc Phuc

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Mesenchymal stem cells (MSCs) were discovered in the 1970s with their unique properties of differentiation, immunomodulation, multiple secreting, and homing factors to injured organs. MSC-based therapies have emerged as a promising strategy for various diseases such as cancer, tissue regeneration, or immunologic/inflammatory-related diseases. This study evaluated the clinical application of MSCs for cancer therapy in trials registered on Clinical Trial as of July 2022. The results showed 40 clinical trials used MSCs in various cancer conditions. 62% of trials used MSCs for therapeutic purposes to minimize the side effects of cancer treatment. Besides, 38% of trials were focused on using MSCs as a therapeutic agent to treat cancer directly. Most trials (38/40) are ongoing phase I/II, and 2 are entering phase III. 84% of trials used allogeneic MSCs compared with 13% using autologous sources and 3% using both. 25/40 trials showed participants received a single dose of MSCs, while the most times were 12 times in a pancreatic cancer treatment trial. Conclusion: MSC-based therapy for cancer in clinical trials should be applied to (1) minimize the side effects of oncological treatments and (2) directly affect the tumor via selectively delivering anti-cancer payloads to tumor cells. Allogeneic MSCs are a priority selected in clinical cancer therapy.

Keywords: mesenchymal stem cells, MSC-based therapy, cancer condition, cancer treatment, clinical trials

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Authors: Arman Kishan, Mark Haft, Steve Li, Duc Nguyen, Dawn Laporte

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Objective: Patients with Type 2 diabetes (T2DM) often face higher postoperative complication rates. Limited data exist on outcomes in T2DM patients undergoing carpal tunnel release (CTR). This study aims to compare complication rates between endoscopic CTR (ECTR) and open CTR (OCTR) in patients with T2DM. Methods: This was a retrospective cohort study using the TriNetX database of 56741 patients with T2DM undergoing ECTR (N= 14,949) or OCTR (N= 41,792). Demographic data, medical comorbidities, and complication rates were analyzed. We used multivariable analysis to identify differences in postoperative complication rates between the two treatment methods in patients with T2DM. Results: Patients with T2DM undergoing ECTR had a significantly lower incidence of 90-day wound infection (p < 0.001), 90-day wound dehiscence (p < 0.001), and nerve injury (p < 0.001) when compared to patients who underwent OCTR. After matching, there was a significantly higher number of T2DM patients undergoing ECTR who had peripheral vascular disease (p = 0.045) and hypertension (p = 0.020) when compared to the OCTR group. These patients also had a lower incidence of fluid and electrolyte disorders (p = 0.002) and chronic blood loss anemia (p = 0.025). Conclusion: ECTR presents a superior choice for T2DM patients undergoing CTR, yielding significantly lower rates of wound infection, wound dehiscence, and nerve injury within 90 days post-surgery—reducing the risk by 31%, 48%, and 59%, respectively. These findings support the adoption of ECTR as the preferred method in this patient population, potentially leading to improved postoperative outcomes.

Keywords: endoscopic treatment of carpal tunnel syndrome, open treatment of carpal tunnel syndrome, carpal tunnel syndrome, postoperative complications in patients with diabetes mellitus

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Authors: Aihong Zhao, Priya Sastry, Mark L Field, Mohamad Bashir, Arvind Singh, David Richens

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Objectives: Intramural haematoma (IMH) is one of the pathologies, along with acute aortic dissection, that present as Acute Aortic Syndrome (AAS). Evidence suggests that unlike aortic dissection, some intramural haematomas may regress with medical management. However, intramural haematomas have been traditionally managed like acute aortic dissections. Given that some of these pathologies may regress with conservative management, it would be useful to be able to identify which of these may not need high risk emergency intervention. A computational aortic model was used in this study to try and identify intramural haematomas with risk of progression to aortic dissection. Methods: We created a computational model of the aorta with luminal blood flow. Reports in the literature have identified 11 mm as the radial clot thickness that is associated with heightened risk of progression of intramural haematoma. Accordingly, haematomas of varying sizes were implanted in the modeled aortic wall to test this hypothesis. The model was exposed to physiological blood flows and the stresses and strains in each layer of the aortic wall were recorded. Results: Size and shape of clot were seen to affect the magnitude of aortic stresses. The greatest stresses and strains were recorded in the intima of the model. When the haematoma exceeded 10 mm in all dimensions, the stress on the intima reached breaking point. Conclusion: Intramural clot size appears to be a contributory factor affecting aortic wall stress. Our computer simulation corroborates clinical evidence in the literature proposing that IMH diameter greater than 11 mm may be predictive of progression. This preliminary report suggests finite element modelling of the aortic wall may be a useful process by which to examine putative variables important in predicting progression or regression of intramural haematoma.

Keywords: intramural haematoma, acute aortic syndrome, finite element analysis,

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Authors: Abiola Falilat Ibraheem, Akinyimika Sowunmi, Valerie Otti

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Background: Introduction of innovative cancer clinical trials to Nigeria is a critical step in addressing global inequities of cancer burden. Low health and clinical trial literacy among Nigerian patients have been sighted as a significant barrier to ensuring that patients enrolled in clinical trials are truly informed. Video intervention has been shown to be the most proactive method to improving patient’s clinical trial knowledge. In the US, video interventions have been successful at improving education about cancer clinical trials among minority patients. Thus, this study aimed to apply and adapt video interventions addressing attitudinal barriers peculiar to Nigerian patients. Methods: A hospital-based representative mixed-method study was conducted at the Lagos State University Teaching Hospital (LASUTH) from July to December 2020, comprising of cancer patients aged 18 and above. Patients were randomly selected during every clinic day, of which 63 patients volunteered to participate in this study. We first administered a cancer literacy survey to determine patients’ knowledge about clinical trials. For patients who had prior knowledge, a pre-intervention test was administered, after which a 15-minute video (attitudes and intention to enroll in therapeutic clinical trials (AIET)) to improve patients’ knowledge, perception, and attitudes towards clinical trials was played, and then ended by administering a post-intervention test to the patients. For patients who had no prior knowledge, the AIET video was played for them, followed by the post-intervention test. Results: Out of 63 patients sampled, 43 (68.3%) had breast cancer. On average, patients agreed to understand their cancer diagnosis and treatment very well. 84.1% of patients had never heard about cancer clinical trials, and 85.7% did not know what cancer clinical trials were. There was a strong positive relationship (r=0.916) between the pretest and posttest, which means that the intervention improved patients’ knowledge, perception, and attitudes about cancer clinical trials. In the focus groups, patients recommended adapting the video in Nigerian settings and representing all religions in order to address trust in local clinical trialists. Conclusion: Due to the small size of patients, change in clinical trial knowledge was not statistically significant. However, there is a trend suggesting that culturally adapted video interventions can be used to improve knowledge and perception about cancer clinical trials.

Keywords: clinical trials, culturally targeted intervention, patient education, video intervention

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Authors: Mohamed Radwan

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Introduction: Polycystic ovary syndrome is becoming very common among girls from ages 14 to 21 years old, alongside women in their childbearing period. A combination of menstrual irregularities, overweight or obesity, insulin resistance (type 2 diabetes), and symptoms of virilization are characteristics of these cases. Background: A multidisciplinary team should be involved in managing these cases and may consist of A gynecologist, endocrinologist, nutritionist, and psychologist. The role of nutritionists is crucial in these cases in weight reduction and nutritional management. It is mandatory to present some questions that may help in expanding further our understanding of the nutritional management of this syndrome, such as it is not an easy process to reduce the weight of PCO patients (2) we need to know what suitable nutritional plans for these cases are. Methodology: It is not successful to use one diet plan for all patients or a specific plan, but we need to give tailored plans for each patient. We will summarize the medical, nutritional therapy and weight management in polycystic ovary patients and highlight the best eating plan and dietary composition in the treatment of these women. We will also discuss the role of dieticians in treating polycystic ovary cases and overcoming the challenges these women face. Conclusion: All diet plans would decrease the weight of Polycystic ovary cases as low calory diet, low glycemic index diet, high protein diet, as well as Dash diet, but the most suitable diet plan to improve hormones and lead to spontaneous pregnancy is the Mediterranean diet.

Keywords: obesity, PCO mediteranian diet, dash diet, high protein diet

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Authors: Thuraya Ahmed Hamood Al Shidhani

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Sports Medicine injuries are very common in primary health care. It is not necessary related to direct trauma, but it could be because of repetitive stress and overuse injuries. Knowledge of Primary Health care providers about the common sports medicine injuries and when to refer to a specialist is essential. Common sports injuries are muscle strain, joint sprain, bone bruise, Patellofemoral pain syndrome, Anterior cruciate ligament injuries, meniscal injuries, ankle ligaments injuries, concussion, Rotator cuff tendinosis/impingement syndrome, lateral and medial epicondylitis and fractures. Systematic approach is very useful in evaluation of sports injuries. RICE is important in initial management. Physiotherapy is essential for rehabilitation. Definitive Management is dependent on patient’s condition and function.

Keywords: common, sports medicine injuries, primary health care, injuries

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Authors: Myoungsoon You, Heejung Son

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During a pandemic, hospital workers should protect not only their vulnerable patients but also themselves from the consequences of rapidly spreading infection. However, the evidence on the psychological impact of an outbreak on hospital workers is limited. In this study, we aim to assess hospital workers’ psychological well-being and function at the workplace after an outbreak, by focusing on ‘psychological resilience’. Specifically, the effects of risk appraisal, emotional experience, and coping ability on resilience indicated by the likelihood of post-traumatic syndrome disorder and willingness to work were investigated. Such role and position of each factor were analyzed using a path model, and the result was compared between the healthcare worker and non-healthcare worker groups. In the investigation, 280 hospital workers who experienced the 2015 Middle East Respiratory Syndrome outbreak in South Korea have participated. The result presented, in both groups, the role of the appraisal of risk and coping ability appeared consistent with a previous research, that was, the former interrupted resilience while the latter facilitated it. In addition, the role of emotional experience was highlighted as, in both groups, emotional disruption not only directly associated with low resilience but mediated the effect of perceived risk on resilience. The differences between the groups were also identified, which were, the role of emotional experience and coping ability was more prominent in the non-HCW group in explaining resilience. From the results, implications on how to support hospital personnel during an outbreak in a way to facilitate their resilience after the outbreak were drawn.

Keywords: hospital workers, emotions, infectious disease outbreak, psychological resilience

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Authors: Sundip Charmode, Simmi Mehra, Sudhir Kushwaha, Shalom Philip, Pratik Amrutiya, Ranjna Jangal

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Introduction: Quadrangular space syndrome involves compression of the axillary nerve and posterior circumflex humeral artery and its management in few cases, requires surgical decompression. The current study reviews the surgical approaches used in the decompression of neurovascular structures and presents our reflections and recommendations. Methods: Four human cadavers, in the Department of Anatomy were used for dissection of the Axillae and the Scapular region by the senior residents of the Department of Anatomy and Department of Orthopedics, who dissected quadrangular space in the eight upper limbs, using anterior and posterior surgical approaches. Observations: Posterior approach to identify the quadrangular space and secure its contents was recognized as the easier and much quicker method by both the Anatomy and Orthopedic residents, but it may result in increased postoperative morbidity. Whereas the anterior (Delto-pectoral) approach involves more skill but reduces postoperative morbidity. Conclusions: Anterior (Delto-pectoral) approach with suggested modifications can prove as an effective method in surgical decompression of quadrangular space syndrome. The authors suggest more cadaveric studies to facilitate anatomists and surgeons with the opportunities to practice and evaluate older and newer surgical approaches.

Keywords: surgical approach, anatomical approach, decompression, axillary nerve, quadrangular space

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Authors: Vidhi Chandra, Arshpreet Singh Grewal

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A five-year-old male child born from non-consanguineous marriage, who presented with complaints of growth retardation and no appreciable increase in the penile size since birth and he was posted for de-gloving of penis with dissection of corpora under anaesthesia. After thorough preoperative evaluation it was revealed that patient had peculiar facial dysmorphism that of Robinow Syndrome, high arched palate, Mallampati grade III, mesomelic limbs, scoliotic spine and short stature. All routine investigation were within normal limit, electrocardiography (ECG) and 2D-Echocardiography (ECHO) were normal. In antero-posterior roentgenogram chest showed butterfly and hemivertebrae at multiple levels. The patient was considered to be ASA II. On the day of surgery after ensuring fasting of 6 hours, patient was taken in operation theatre, all standard ASA monitoring was done with ECG, non-invasive blood pressure, peripheral oxygen saturation (SpO2) and body temperature. The patient was pre-oxygenated with 100% oxygen with anatomical face mask. General anaesthesia was induced with Sevoflurane 1-8%, and airway was secured with an appropriate size supraglottic airway and anaesthesia was maintained with nitrous oxide and oxygen in 1:1 ratio along with sevoflurane 2%. An ultrasound guided caudal block was given owing to the skeletal deformities making it difficult even under USG guidance. Post operatively patient was given supportive care with proper hydration, antibiotics, anti-inflammatory and analgesics. He was discharged the next day and followed up weekly for a month. DISCUSSION Robinow syndrome is genetically inherited as autosomal dominant, autosomal recessive or heterogenous disorder involving tyrosine kinase ROR2 gene located on chromosome 9. It has low incidence with no preponderance for any gender. Though intelligence is normal but developmental delay and mental retardation occurs in 20%cases

Keywords: Robinow Syndrome, dwarfism, paediatric, anaesthesia

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Authors: Saboor Saeed, Chunming Jiang

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Eosinophilic Granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss syndrome, is a rare systemic vasculitis of small and medium-sized vessels that primarily develops in middle-aged individuals. It is characterized by asthma, blood eosinophilia, and extra pulmonary manifestations. In childhood, EGPA is extremely rare. Pulmonary and cardiac involvement is predominant in pediatric EGPA, and mortality is substantial. Generally, EGPA will develop in three stages: a) The allergic phase is commonly associated with asthma, allergic rhinitis, and sinusitis, b) the eosinophilic phase, in which the main pathology is related to the infiltration of eosinophilic organs, i.e., lung, heart, and gastrointestinal system, c) vasculitis phase involved purpura, peripheral neuropathy, and some constitutional symptoms. The key to the treatment of EGPA lies in the early diagnosis of the disease. Early application of glucocorticoids and immunosuppressants can improve symptoms and the overall prognosis of EGPA. Case Description: We presented a case of an 8-year-old boy with a history of short asthma, marked eosinophilia, and multi-organ involvement. The extremely high eosinophil level in the blood (72.50%) prompted the examination of eosinophilic leukemia before EGPA diagnosis was made. Subsequently, this disease was successfully treated. This case report shows a typical case of CSS in childhood because of the extreme eosinophilia. It emphasizes the importance of EGPA is a life-threatening cause of children's eosinophilia. Conclusion: EGPA in children has unique clinical, imaging, and histological characteristics different from those of adults. In pediatric patients, the development and diagnosis of systemic symptoms are often delayed, mainly occurring in the eosinophilic phase, which will lead to specific manifestations. At the same time, we cannot detect a genetic relationship related to EGPA.

Keywords: Churg Strauss syndrome, asthma, vasculitis, hypereosinophilia, eosinophilic granulomatosis polyangiitis

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Authors: Eduardo Cabrera-Rode, Janet Rodriguez, Aimee Alvarez, Ragmila Echevarria, Antonio D. Reyes, Ileana Cubas-Duenas, Silvia E. Turcios, Oscar Diaz-Diaz

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Obex is a nutritional supplement to help weight loss naturally. In addition, this supplement has a satiating effect that helps control the craving to eat between meals. The purpose of this study was to evaluate the effect of Obex in the metabolic syndrome (MS). This was an open label pilot study conducted in 30 patients with MS and ages between 29 and 60 years old. Participants received Obex, at a dose of one sachet before (30 to 45 minutes) the two main meals (lunch and dinner) daily (mean two sachets per day) for 3 months. The content of the sachets was dissolved in a glass of water or fruit juice. Obex ingredients: Açai (Euterpe oleracea Mart.) berry, inulin, Phaseolus vulgaris, Caralluma fimbriata, inositol, choline, arginine, ornitine, zinc sulfate, carnitine fumarate, methionine, calcium pantothenate, pyridoxine and folic acid. In addition to anthropometric measures and blood pressure, fasting plasma glucose, total cholesterol, triglycerides and HDL-cholesterol and insulin were determined. Insulin resistance was assessed by HOMA-IR index. Three indirect indexes were used to calculate insulin sensitivity [QUICKI index (Quantitative insulin sensitivity check index), Bennett index and Raynaud index]. Metabolic syndrome was defined according to the Joint Interim Statement (JIS) criteria. The JIS criteria require at least three of the following components: (1) abdominal obesity (waist circumference major or equal major or equal 94 cm for men or 80 cm for women), (2) triglycerides major or equal 1.7 mmol/L, (3) HDL cholesterol minor 1.03 mmol/L for men or minor 1.30 mmol/L for women, (4) systolic/diastolic blood pressure major or equal 130/85mmHg or use antihypertensive drugs, and (5) fasting plasma glucose major or equal 5.6 mmol/L or known treatment for diabetes. This study was approved by the Ethical and Research Committee of the National Institute of Endocrinology, Cuba and conducted according to the Declaration of Helsinki. Obex is registered as a food supplement in the National Institute of Nutrition and Food, Havana, Cuba. Written consent was obtained from all patients before the study. The clinical trial had been registered at ClinicalTrials.gov. After three months of treatment, 43.3% (13/30) of participants decreased the frequency of MS. Compared to baseline, Obex significantly reduced body weight, BMI, waist circumference, and waist/hip ratio and improved HDL-c (p<0.0001) and in addition to lowering blood pressure (p<0.05). After Obex intake, subjects also have shown a reduction in fasting plasma glucose (p<0.0001) and insulin sensitivity was enhanced (p=0.001). No adverse effects were seen in any of the participants during the study. In this pilot study, consumption of Obex decreased the prevalence of MS due to the improved selected components of the metabolic syndrome, indicating that further studies are warranted. Obex emerges as an effective and well tolerated treatment for preventing or delaying MS and therefore potential reduction of cardiovascular risk.

Keywords: nutritional supplement, metabolic syndrome, weight loss, insulin resistance

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