Search results for: clinical research (CRE)
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 27295

Search results for: clinical research (CRE)

26635 Insight into Figo Sub-classification System of Uterine Fibroids and Its Clinical Importance as Well as MR Imaging Appearances of Atypical Fibroids

Authors: Madhuri S. Ghate, Rahul P. Chavhan, Shriya S. Nahar

Abstract:

Learning objective: •To describe Magnetic Resonance Imaging (MRI) imaging appearances of typical and atypical uterine fibroids with emphasis on differentiating it from other similar conditions. •To classify uterine fibroids according to International Federation of Gynecology and Obstetrics (FIGO) Sub-classifications system and emphasis on its clinical significance. •To show cases with atypical imaging appearances atypical fibroids Material and methods: MRI of Pelvis had been performed in symptomatic women of child bearing age group on 1.5T and 3T MRI using T1, T2, STIR, FAT SAT, DWI sequences. Contrast was administered when degeneration was suspected. Imaging appearances of Atypical fibroids and various degenerations in fibroids were studied. Fibroids were classified using FIGO Sub-classification system. Its impact on surgical decision making and clinical outcome were also studied qualitatively. Results: Intramural fibroids were most common (14 patients), subserosal 7 patients, submucosal 5 patients . 6 patients were having multiple fibroids. 7 were having atypical fibroids. (1 hyaline degeneration, 1 cystic degeneration, 1 fatty, 1 necrosis and hemorrhage, 1 red degeneration, 1 calcification, 1 unusual large bilobed growth). Fibroids were classified using FIGO system. In uterus conservative surgeries, the lesser was the degree of myometrial invasion of fibroid, better was the fertility outcome. Conclusion: Relationship of fibroid with mucosal and serosal layers is important in the management of symptomatic fibroid cases. Risk to fertility involved in uterus conservative surgeries in women of child bearing age group depends on the extent of myometrial invasion of fibroids. FIGO system provides better insight into the degree of myometrial invasion. Knowledge about the atypical appearances of fibroids is important to avoid diagnostic confusion and untoward treatment.

Keywords: degeneration, FIGO sub-classification, MRI pelvis, uterine fibroids

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26634 Antimicrobial Resistance of Acinetobacter baumannii in Veterinary Settings: A One Health Perspective from Punjab, Pakistan

Authors: Minhas Alam, Muhammad Hidayat Rasool, Mohsin Khurshid, Bilal Aslam

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The genus Acinetobacter has emerged as a significant concern in hospital-acquired infections, particularly due to the versatility of Acinetobacter baumannii in causing nosocomial infections. The organism's remarkable metabolic adaptability allows it to thrive in various environments, including the environment, animals, and humans. However, the extent of antimicrobial resistance in Acinetobacter species from veterinary settings, especially in developing countries like Pakistan, remains unclear. This study aimed to isolate and characterize Acinetobacter spp. from veterinary settings in Punjab, Pakistan. A total of 2,230 specimens were collected, including 1,960 samples from veterinary settings (nasal and rectal swabs from dairy and beef cattle), 200 from the environment, and 70 from human clinical settings. Isolates were identified using routine microbiological procedures and confirmed by polymerase chain reaction (PCR). Antimicrobial susceptibility was determined by the disc diffusion method, and minimum inhibitory concentration (MIC) was measured by the micro broth dilution method. Molecular techniques, such as PCR and DNA sequencing, were used to screen for antimicrobial-resistant determinants. Genetic diversity was assessed using standard techniques. The results showed that the overall prevalence of A. baumannii in cattle was 6.63% (65/980). However, among cattle, a higher prevalence of A. baumannii was observed in dairy cattle, 7.38% (54/731), followed by beef cattle, 4.41% (11/249). Out of 65 A. baumannii isolates, the carbapenem resistance was found in 18 strains, i.e. 27.7%. The prevalence of A. baumannii in nasopharyngeal swabs was higher, i.e., 87.7% (57/65), as compared to rectal swabs, 12.3% (8/65). Class D β-lactamases genes blaOXA-23 and blaOXA-51 were present in all the CRAB from cattle. Among carbapenem-resistant isolates, 94.4% (17/18) were positive for class B β-lactamases gene blaIMP, whereas the blaNDM-1 gene was detected in only one isolate of A. baumannii. Among 70 clinical isolates of A. baumannii, 58/70 (82.9%) were positive for the blaOXA-23-like gene, and 87.1% (61/70) were CRAB isolates. Among all clinical isolates of A. baumannii, blaOXA-51-like gene was present. Hence, the co-existence of blaOXA-23 and blaOXA-51 was found in 82.85% of clinical isolates. From the environmental settings, a total of 18 A. baumannii isolates were recovered; among these, 38.88% (7/18) strains showed carbapenem resistance. All environmental isolates of A. baumannii harbored class D β-lactamases genes, i.e., blaOXA-51 and blaOXA-23 were detected in 38.9% (7/18) isolates. Hence, the co-existence of blaOXA-23 and blaOXA-51 was found in 38.88% of isolates. From environmental settings, 18 A. baumannii isolates were recovered, with 38.88% showing carbapenem resistance. All environmental isolates harbored blaOXA-51 and blaOXA-23 genes, with co-existence in 38.88% of isolates. MLST results showed ten different sequence types (ST) in clinical isolates, with ST 589 being the most common in carbapenem-resistant isolates. In veterinary isolates, ST2 was most common in CRAB isolates from cattle. Immediate control measures are needed to prevent the transmission of CRAB isolates among animals, the environment, and humans. Further studies are warranted to understand the mechanisms of antibiotic resistance spread and implement effective disease control programs.

Keywords: Acinetobacter baumannii, carbapenemases, drug resistance, MSLT

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26633 Data Protection and Regulation Compliance on Handling Physical Child Abuse Scenarios- A Scoping Review

Authors: Ana Mafalda Silva, Rebeca Fontes, Ana Paula Vaz, Carla Carreira, Ana Corte-Real

Abstract:

Decades of research on the topic of interpersonal violence against minors highlight five main conclusions: 1) it causes harmful effects on children's development and health; 2) it is prevalent; 3) it violates children's rights; 4) it can be prevented and 5) parents are the main aggressors. The child abuse scenario is identified through clinical observation, administrative data and self-reports. The most used instruments are self-reports; however, there are no valid and reliable self-report instruments for minors, which consist of a retrospective interpretation of the situation by the victim already in her adult phase and/or by her parents. Clinical observation and collection of information, namely from the orofacial region, are essential in the early identification of these situations. The management of medical data, such as personal data, must comply with the General Data Protection Regulation (GDPR), in Europe, and with the General Law of Data Protection (LGPD), in Brazil. This review aims to answer the question: In a situation of medical assistance to minors, in the suspicion of interpersonal violence, due to mistreatment, is it necessary for the guardians to provide consent in the registration and sharing of personal data, namely medical ones. A scoping review was carried out based on a search by the Web of Science and Pubmed search engines. Four papers and two documents from the grey literature were selected. As found, the process of identifying and signaling child abuse by the health professional, and the necessary early intervention in defense of the minor as a victim of abuse, comply with the guidelines expressed in the GDPR and LGPD. This way, the notification in maltreatment scenarios by health professionals should be a priority and there shouldn’t be the fear or anxiety of legal repercussions that stands in the way of collecting and treating the data necessary for the signaling procedure that safeguards and promotes the welfare of children living with abuse.

Keywords: child abuse, disease notifications, ethics, healthcare assistance

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26632 Hypotonia - A Concerning Issue in Neonatal Care

Authors: Eda Jazexhiu-Postoli, Gladiola Hoxha, Ada Simeoni, Sonila Biba

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Background Neonatal hypotonia represents a commonly encountered issue in the Neonatal Intensive Care Unit and newborn nursery. The differential diagnosis is broad, encompassing chromosome abnormalities, primary muscular dystrophies, neuropathies and inborn errors of metabolism. Aim of study Our study describes some of the main clinical features of hypotonia in newborns and presents clinical cases of neonatal hypotonia we treated in our Neonatal unit in the last 3 years. Case reports Four neonates born in our hospital presented with hypotonia after birth, one preterm newborn 35-36 weeks of gestational age and three other term newborns (38-39 weeks of gestational age). Prenatal data revealed a decrease in fetal movements in both cases. Intrapartum meconium-stained amniotic fluid was found in 75% of our hypotonic newborns. Clinical features included inability to establish effective respiratory movements and need for resuscitation in the delivery room, respiratory distress syndrome, feeding difficulties and need for oro-gastric tube feeding, dysmorphic features, hoarse voice and moderate to severe muscular hypotonia. The genetic workup revealed the diagnosis of Autosomal Recessive Congenital Myasthenic Syndrome 1-B, Sotos Syndrome, Spinal Muscular Atrophy Type 1 and Transient Hypotonia of the Newborn. Two out of four hypotonic neonates were transferred to the Pediatric Intensive Care Unit and died at the age of three to five months old. Conclusion Hypotonia is a concerning finding in neonatal care and it is suggested by decreased intrauterine fetal movements, failure to establish first breaths, respiratory distress and feeding difficulties in the neonate. Prognosis is determined by its etiology and time of diagnosis and intervention.

Keywords: hypotonic neonate, respiratory distress, feeding difficulties, fetal movements

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26631 Clinicoradiographic Evaluation of Polymer of Injectable Platelet-Rich Fibrin (i-PRF) and Hydroxyapatite as Bone Graft Substitute in Maxillomandibular Bony Defects: A Double-Blinded Randomized Control Trial

Authors: Naqoosh Haidry

Abstract:

Objective & Goal: Enucleation of the maxillomandibular cysts will lead to the creation of post-surgical bone defects which may take more than a year for complete bone healing. The use of bone grafts is common to aid bone regeneration in large defects. The study aimed to evaluate the healing and bone formation capabilities of polymer of injectable platelet fibrin (i-PRF) and hydroxyapatite (HA) as bone graft substitute in maxilla-mandibular postsurgical defects compared to hydroxyapatite alone. The primary objective was to find out the clinical and radiological assessment of healing postoperatively and compare the outcome of both groups. Material and Methods: After surgical enucleation of 19 maxillomandibular cysts/tumors, either HA or HA+ i-PRF graft was adapted to the defect. Clinical outcome variables such as pain (VAS score), edema, and mucosal color were evaluated on postoperative days 01, 03, and 07 while radiological outcome variables such as volume of defect (cc), density of new bone (HU) on computed tomography were evaluated at 2nd and 4th month. The results obtained were tabulated and compared with the inferential analysis. Results: Clinical parameters seem to be better in the HA + i-PRF group, but the result was non-significant. Radiologically, the mean healing ratios were significantly greater in the HA + i-PRF group (63.5 ± 2.34 at 2nd month, 90.3 ± 7.32 at 4th month) compared to the HA group (57.2 ± 5.21at 2nd month, 80.8 ± 5.33 at 4th month). When comparing the mean density of new bone, there was a statistically significant difference with a mean difference of 95.2 HU more in the HA + i-PRF (623 HU ± 42.9) compared to the HA group (528 HU ± 96.5) in 2nd month. Conclusion: The polymer of i-PRF and HA prepared as the sticky bone yields faster and better bone healing in post-enucleation maxillomandibular bony defects as compared to hydroxyapatite alone based on radiological findings till four months.

Keywords: bone defect, density of new bone, hydroxyapatite, injectable platelet rich fibrin, maxillomandibular cysts, surgical defect

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26630 Clinical Presentation and Immune Response to Intramammary Infection of Holstein-Friesian Heifers with Isolates from Two Staphylococcus aureus Lineages

Authors: Dagmara A. Niedziela, Mark P. Murphy, Orla M. Keane, Finola C. Leonard

Abstract:

Staphylococcus aureus is the most frequent cause of clinical and subclinical bovine mastitis in Ireland. Mastitis caused by S. aureus is often chronic and tends to recur after antibiotic treatment. This may be due to several virulence factors, including attributes that enable the bacterium to internalize into bovine mammary epithelial cells, where it may evade antibiotic treatment, or evade the host immune response. Four bovine-adapted lineages (CC71, CC97, CC151 and ST136) were identified among a collection of Irish S. aureus mastitis isolates. Genotypic variation of mastitis-causing strains may contribute to different presentations of the disease, including differences in milk somatic cell count (SCC), the main method of mastitis detection. The objective of this study was to investigate the influence of bacterial strain and lineage on host immune response, by employing cell culture methods in vitro as well as an in vivo infection model. Twelve bovine adapted S. aureus strains were examined for internalization into bovine mammary epithelial cells (bMEC) and their ability to induce an immune response from bMEC (using qPCR and ELISA). In vitro studies found differences in a variety of virulence traits between the lineages. Strains from lineages CC97 and CC71 internalized more efficiently into bovine mammary epithelial cells (bMEC) than CC151 and ST136. CC97 strains also induced immune genes in bMEC more strongly than strains from the other 3 lineages. One strain each of CC151 and CC97 that differed in their ability to cause an immune response in bMEC were selected on the basis of the above in vitro experiments. Fourteen first-lactation Holstein-Friesian cows were purchased from 2 farms on the basis of low SCC (less than 50 000 cells/ml) and infection free status. Seven cows were infected with 1.73 x 102 c.f.u. of the CC97 strain (Group 1) and another seven with 5.83 x 102 c.f.u. of the CC151 strain (Group 2). The contralateral quarter of each cow was inoculated with PBS (vehicle). Clinical signs of infection (temperature, milk and udder appearance, milk yield) were monitored for 30 days. Blood and milk samples were taken to determine bacterial counts in milk, SCC, white blood cell populations and cytokines. Differences in disease presentation in vivo between groups were observed, with two animals from Group 2 developing clinical mastitis and requiring antibiotic treatment, while one animal from Group 1 did not develop an infection for the duration of the study. Fever (temperature > 39.5⁰C) was observed in 3 animals from Group 2 and in none from Group 1. Significant differences in SCC and bacterial load between groups were observed in the initial stages of infection (week 1). Data is also being collected on cytokines and chemokines secreted during the course of infection. The results of this study suggest that a strain from lineage CC151 may cause more severe clinical mastitis, while a strain from lineage CC97 may cause mild, subclinical mastitis. Diversity between strains of S. aureus may therefore influence the clinical presentation of mastitis, which in turn may influence disease detection and treatment needs.

Keywords: Bovine mastitis, host immune response, host-pathogen interactions, Staphylococcus aureus

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26629 Multiple Organ Manifestation in Neonatal Lupus Erythematous: Report of Two Cases

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

Abstract:

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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26628 Evaluation of the Improve Vacuum Blood Collection Tube for Laboratory Tests

Authors: Yoon Kyung Song, Seung Won Han, Sang Hyun Hwang, Do Hoon Lee

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Laboratory tests is a significant part for the diagnosis, prognosis, treatment of diseases. Blood collection is a simple process, but can be a potential cause of pre-analytical errors. Vacuum blood collection tubes used to collect and store the blood specimens is necessary for accurate test results. The purpose of this study was to validate Improve serum separator tube(SST) (Guanzhou Improve Medical Instruments Co., Ltd, China) for routine clinical chemistry laboratory testing. Blood specimens were collected from 100 volunteers in three different serum vacuum tubes (Greiner SST , Becton Dickinson SST , Improve SST). The specimens were evaluated for 16 routine chemistry tests using TBA-200FR NEO (Toshiba Medical Co. JAPAN). The results were statistically analyzed by paired t-test and Bland-Altman plot. For stability test, the initial results for each tube were compared with results of 72 hours preserved specimens. Their clinical availability was evaluated by biological Variation of Ricos data bank. Paired t-test analysis revealed that AST, ALT, K, Cl showed statistically same results but calcium (CA), phosphorus(PHOS), glucose(GLU), BUN, uric acid(UA), cholesterol(CHOL), total protein(TP), albumin(ALB), total bilirubin(TB), ALP, creatinine(CRE), sodium(NA) were different(P < 0.05) between Improve SST and Greiner SST. Also, CA, PHOS, TP, TB, AST, ALT, NA, K, Cl showed statistically the same results but GLU, BUN, UA, CHOL, ALB, ALP, CRE were different between Improve SST and Becton Dickinson SST. All statistically different cases were clinically acceptable by biological Variation of Ricos data bank. Improve SST tubes showed satisfactory results compared with Greiner SST and Becton Dickinson SST. We concluded that the tubes are acceptable for routine clinical chemistry laboratory testing.

Keywords: blood collection, Guanzhou Improve, SST, vacuum tube

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26627 Implementation and Use of Person-Centered Care in Europe: A Literature Review

Authors: Kristina Rosengren, Petra Brannefors, Eric Carlstrom

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Background: Implementation and use of person-centered care (PCC) is increasing worldwide, and why the current study intends to increase knowledge regarding how PCC is used in different European countries. Purpose: To describe the extent of person-centred care in 23 European countries in relation to use specific countries healthcare system (Beveridge, Bismarck, Mixed/OOP). Methods: The study was conducted by literature review inspired by Spice, both scientific empirical studies (Cinahl, Medline, Scopus) as well as grey literature (Google) were used. Totally 1194 documents were included divided into Cinahl n=139, Medline n=245, Scopus n=493 and Google n=317. Data were analysed with descriptive (percentage, range) regarding content and scope of PCC/country according to content and scope of PCC in each country, grouped into the healthcare system (Beveridge, Bismarck, Mixed/OOP) and geographic placement. Results: PCC were most common in UK (England, Scotland, Wales, North Ireland), n=481, 40.3%, Sweden (n=231, 19.3%), The Netherlands (n=80, 6.7%), Ireland (n=79, 6.6%) and Norway (n=61, 5.1%); and less common in Poland (0.6%), Hungary (0.5%), Greece (0.4%), Latvia (0.4%) and Serbia (0%). Beveridge healthcare system (12/23=0.5217, 52.2%) show 85 percent of documents with advantage of scientific literature valued 2.92 (n=999, 0.55-4.07), compare to advantage of grey literature in Bismarck (10/23=0.4347, 43.5%) with 15 percentage valued 2.35 (n=190, 0-3.27) followed by Mixed/OOP (1/23=4%) with 0.4 valued 2.25. Conclusions: Seven out of 10 countries with Beveridge health system used PCC compare to less-used PCC in countries with the Bismarck system. Research, as well as national regulations regarding PCC, are important tools to motivate the advantage of PCC in clinical practice. Moreover, implementation of PCC needs a systematic approach, from national (politicians), regional (guideline) and local (specific healthcare settings) levels visualized by decision-making as law, mission, policies, and routines in clinical practice to establish a well-integrated phenomenon in Europe.

Keywords: Beveridge, Bismarck, Europe, evidence-based, literature review, person-centered care

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26626 Refractory T-Cell Prolymphocytic Leukemia with JAK3 Mutation: In Vitro and Clinical Synergy of Tofacitinib and Ruxolitinib

Authors: Mike Wei, Nebu Koshy, Koen van Besien, Giorgio Inghirami, Steven M. Horwitz

Abstract:

T-cell prolymphocytic leukemia (T-PLL) is a rare hematologic disease characterized by a T-cell phenotype, rapid progression, and poor prognosis with median survival of less than a year. Alemtuzumab-based chemotherapy has increased the rate of complete remissions but these are often short-lived, and allogeneic transplant is considered the only curative therapy. In recent studies, JAK3 activating mutations have been identified in T-cell cancers, with T-PLL having the highest rate of JAK3 mutations (30 – 42%). As such, T-PLL is a model disease for evaluating the utility of JAK3 inhibitors. We present a case of a 64-year-old man with relapsed-refractory T-PLL. He was initially treated with alemtuzumab and obtained complete response and was consolidated with matched unrelated donor stem cell transplant. His disease stayed in remission for approximately 1.5 years before relapse, which was then treated with a clinical trial of romidepsin-lenalidomide (partial responses then progression at 6 months) and later alemtuzumab. Due to complications of myelosuppression and CMV reactivation, his treatment was interrupted leading to disease progression. The doubling time of lymphocyte count was approximately 20 days and over a span of 60 days the lymphocyte count rose from 8 x 109/L to 68 x 109/L. Exon sequencing showed a JAK3 mutation. The patient consented to and was treated with FDA-approved tofacitinib (initially 5 mg BID, increased to 10 mg BID after 15 days of treatment). An initial decrease in lymphocyte count was followed by progression. In vitro treatment of the patient’s cells showed modest effects of tofacitinib and ruxolitinib as single agents, in the range of doxorubicin, but synergy between the agents. After 40 days of treatment with tofacitinib and with a lymphocyte count of 150 x 109/L, ruxolitinib (5mg BID) was added. Over the 60 days since dual inhibition was started, the lymphocyte count has stabilized. The patient has remained completely asymptomatic during treatment with tofacitinib and ruxolitinib. Neutrophil count has remained normal. Platelet count and hemoglobin have however declined from ~50 x109/L to ~30 x109/L and from 11 g/dL to 8.1 g/dL respectively, since the introduction of ruxolitinib. The stabilization in lymphocyte count confirms the clinical activity of JAK inhibitors in T-PLL as suggested by the presence of JAK3 mutations and by in-vitro assays. It also suggests clinical synergy between ruxolitinib and tofacitinib in this setting. Prospective studies of JAK inhibitors in PLL patients with formal dose-finding studies are needed.

Keywords: tofacitinib, ruxolitinib, T-cell prolymphocytic leukemia, JAK3

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26625 The Association between IFNAR2 and Dpp9 Genes Single Nucleotide Polymorphisms Frequency with COVID-19 Severity in Iranian Patients

Authors: Sima Parvizi Omran, Rezvan Tavakoli, Mahnaz Safari, Mohammadreza Aghasadeghi, Abolfazl Fateh, Pooneh Rahimi

Abstract:

Background: SARS-CoV-2, a single-stranded RNA betacoronavirus causes the global outbreak of coronavirus disease 2019 (COVID-19). Several clinical and scientific concerns are raised by this pandemic. Genetic factors can contribute to pathogenesis and disease susceptibility. There are single nucleotide polymorphisms (SNPs) in many of the genes in the immune system that affect the expression of specific genes or functions of some proteins related to immune responses against viral infections. In this study, we analyzed the impact of polymorphism in the interferon alpha and beta receptor subunit 2 (IFNAR2) and dipeptidyl peptidase 9 (Dpp9) genes and clinical parameters on the susceptibility and resistance to Coronavirus disease (COVID-19). Methods: A total of 330- SARS-CoV-2 positive patients (188 survivors and 142 nonsurvivors) were included in this study. All single-nucleotide polymorphisms (SNPs) on IFNAR2 (rs2236757) and Dpp9 (rs2109069) were genotyped by the polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) method. Results: In survivor patients, the frequency of the favourable genotypes of IFNAR2 SNP (rs2236757 GC) was significantly higher than in nonsurvivor patients, and also Dpp9 (rs2109069 AT) genotypes were associated with the severity of COVID-19 infection. Conclusions: This study demonstrated that the severity of COVID- 19 patients was strongly associated with clinical parameters and unfavourable IFNAR2, Dpp9 SNP genotypes. In order to establish the relationship between host genetic factors and the severity of COVID-19 infection, further studies are needed in multiple parts of the world.

Keywords: SARS-CoV-2, COVID-19, interferon alpha and beta receptor subunit 2, dipeptidyl peptidase 9, single-nucleotide polymorphisms

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26624 Remote Vital Signs Monitoring in Neonatal Intensive Care Unit Using a Digital Camera

Authors: Fatema-Tuz-Zohra Khanam, Ali Al-Naji, Asanka G. Perera, Kim Gibson, Javaan Chahl

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Conventional contact-based vital signs monitoring sensors such as pulse oximeters or electrocardiogram (ECG) may cause discomfort, skin damage, and infections, particularly in neonates with fragile, sensitive skin. Therefore, remote monitoring of the vital sign is desired in both clinical and non-clinical settings to overcome these issues. Camera-based vital signs monitoring is a recent technology for these applications with many positive attributes. However, there are still limited camera-based studies on neonates in a clinical setting. In this study, the heart rate (HR) and respiratory rate (RR) of eight infants at the Neonatal Intensive Care Unit (NICU) in Flinders Medical Centre were remotely monitored using a digital camera applying color and motion-based computational methods. The region-of-interest (ROI) was efficiently selected by incorporating an image decomposition method. Furthermore, spatial averaging, spectral analysis, band-pass filtering, and peak detection were also used to extract both HR and RR. The experimental results were validated with the ground truth data obtained from an ECG monitor and showed a strong correlation using the Pearson correlation coefficient (PCC) 0.9794 and 0.9412 for HR and RR, respectively. The RMSE between camera-based data and ECG data for HR and RR were 2.84 beats/min and 2.91 breaths/min, respectively. A Bland Altman analysis of the data also showed a close correlation between both data sets with a mean bias of 0.60 beats/min and 1 breath/min, and the lower and upper limit of agreement -4.9 to + 6.1 beats/min and -4.4 to +6.4 breaths/min for both HR and RR, respectively. Therefore, video camera imaging may replace conventional contact-based monitoring in NICU and has potential applications in other contexts such as home health monitoring.

Keywords: neonates, NICU, digital camera, heart rate, respiratory rate, image decomposition

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26623 Development of a Model for Predicting Radiological Risks in Interventional Cardiology

Authors: Stefaan Carpentier, Aya Al Masri, Fabrice Leroy, Thibault Julien, Safoin Aktaou, Malorie Martin, Fouad Maaloul

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Introduction: During an 'Interventional Radiology (IR)' procedure, the patient's skin-dose may become very high for a burn, necrosis, and ulceration to appear. In order to prevent these deterministic effects, a prediction of the peak skin-dose for the patient is important in order to improve the post-operative care to be given to the patient. The objective of this study is to estimate, before the intervention, the patient dose for ‘Chronic Total Occlusion (CTO)’ procedures by selecting relevant clinical indicators. Materials and methods: 103 procedures were performed in the ‘Interventional Cardiology (IC)’ department using a Siemens Artis Zee image intensifier that provides the Air Kerma of each IC exam. Peak Skin Dose (PSD) was measured for each procedure using radiochromic films. Patient parameters such as sex, age, weight, and height were recorded. The complexity index J-CTO score, specific to each intervention, was determined by the cardiologist. A correlation method applied to these indicators allowed to specify their influence on the dose. A predictive model of the dose was created using multiple linear regressions. Results: Out of 103 patients involved in the study, 5 were excluded for clinical reasons and 2 for placement of radiochromic films outside the exposure field. 96 2D-dose maps were finally used. The influencing factors having the highest correlation with the PSD are the patient's diameter and the J-CTO score. The predictive model is based on these parameters. The comparison between estimated and measured skin doses shows an average difference of 0.85 ± 0.55 Gy for doses of less than 6 Gy. The mean difference between air-Kerma and PSD is 1.66 Gy ± 1.16 Gy. Conclusion: Using our developed method, a first estimate of the dose to the skin of the patient is available before the start of the procedure, which helps the cardiologist in carrying out its intervention. This estimation is more accurate than that provided by the Air-Kerma.

Keywords: chronic total occlusion procedures, clinical experimentation, interventional radiology, patient's peak skin dose

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26622 Lamb Wave-Based Blood Coagulation Measurement System Using Citrated Plasma

Authors: Hyunjoo Choi, Jeonghun Nam, Chae Seung Lim

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Acoustomicrofluidics has gained much attention due to the advantages, such as noninvasiveness and easy integration with other miniaturized systems, for clinical and biological applications. However, a limitation of acoustomicrofluidics is the complicated and costly fabrication process of electrodes. In this study, we propose a low-cost and lithography-free device using Lamb wave for blood analysis. Using a Lamb wave, calcium ion-removed blood plasma and coagulation reagents can be rapidly mixed for blood coagulation test. Due to the coagulation process, the viscosity of the sample increases and the viscosity change can be monitored by internal acoustic streaming of microparticles suspended in the sample droplet. When the acoustic streaming of particles stops by the viscosity increase is defined as the coagulation time. With the addition of calcium ion at 0-25 mM, the coagulation time was measured and compared with the conventional index for blood coagulation analysis, prothrombin time, which showed highly correlated with the correlation coefficient as 0.94. Therefore, our simple and cost-effective Lamb wave-based blood analysis device has the powerful potential to be utilized in clinical settings.

Keywords: acoustomicrofluidics, blood analysis, coagulation, lamb wave

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26621 The Study of Periodontal Health Status in Menopausal Women with Osteoporosis Referred to Rheumatology Clinics in Yazd and Healthy People

Authors: Mahboobe Daneshvar

Abstract:

Introduction: Clinical studies on the effect of systemic conditions on periodontal diseases have shown that some systemic deficiencies may provide grounds for the onset of periodontal diseases. One of these systemic problems is osteoporosis, which may be a risk factor for the onset and exacerbation of periodontitis. This study tends to evaluate periodontal indices in osteoporotic menopausal women and compare them with healthy controls. Materials and Methods: In this case-control study, participants included 45-75-year-old menopausal women referred to rheumatology wards of the Khatamolanbia Clinic and Shahid Sadoughi Hospital in Yazd; Their bone density was determined by DEXA-scan and by imaging the femoral-lumbar bone. Thirty patients with osteoporosis and 30 subjects with normal BMD were selected. Then, informed consent was obtained for participation in the study. During the clinical examinations, tooth loss (TL), plaque index (PI), gingival recession, pocket probing depth (PPD), clinical attachment loss (CAL), and tooth mobility (TM) were measured to evaluate the periodontal status. These clinical examinations were performed to determine the periodontal status by catheter, mirror and probe. Results: During the evaluation, there was no significant difference in PPD, PI, TM, gingival recession, and CAL between case and control groups (P-value>0.05); that is, osteoporosis has no effect on the above factors. These periodontal factors are almost the same in both healthy and patient groups. In the case of missing teeth, the following results were obtained: the mean of missing teeth was 22.173% of the total teeth in the case group and 18.583% of the total teeth in the control group. In the study of the missing teeth in the case and control groups, there was a significant relationship between case and control groups (P-value = 0.025). Conclusion: In fact, since periodontal disease is multifactorial and microbial plaque is the main cause, osteoporosis is considered a predisposing factor in exacerbation or persistence of periodontal disease. In patients with osteoporosis, usually pathological fractures, hormonal changes, and aging lead to reduced physical activity and affect oral health, which leads to the manifestation of periodontal disease. But this disease increases tooth loss by changing the shape and structure of bone trabeculae and weakening them. Osteoporosis does not seem to be a deterministic factor in the incidence of periodontal disease, since it affects bone quality rather than bone quantity.

Keywords: plaque index, Osteoporosis, tooth mobility, periodontal packet

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26620 The Effect of Exercise Therapy and Electroacupuncture on Some Clinical Outcomes in People with Post Total Hip Arthroplasty

Authors: Marzieh Yassin, Masoud Rashed, Soheil Mansour Sohani, Reza Salehi

Abstract:

Background: Hip arthroplasty is one of the surgical methods to improve symptoms in patients with hip osteoarthritis. The use of electroacupuncture and TENS reduces pain, increases range of motion and improves performance. Methods: In this clinical trial study, 30 patients after hip arthroplasty were randomly divided into two groups: electroacupuncture (n=16) with exercise therapy and TENS with exercise therapy (n=14). Severity of pain, quality of life, range of motion, edema and function were evaluated in two groups before and after the interventions. Interventions of 10 sessions (three sessions per week) were conducted for two groups. The significance level in all tests was below 0.05. Results: The results showed that both groups improved all of the symptoms after the intervention (p≤0.05), although there was no statistically significant difference between the two groups in terms of effectiveness (p≥0.05). Conclusion: The results showed that both methods improve symptoms in patients after surgery. According to this study, electroacupuncture is suggested as a new method effective for the treatment of people with post-Total Hip Arthroplasty.

Keywords: electroacupuncture, physical performance, total hip arthroplasty, TENS

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26619 Your First Step to Understanding Research Ethics: Psychoneurolinguistic Approach

Authors: Sadeq Al Yaari, Ayman Al Yaari, Adham Al Yaari, Montaha Al Yaari, Aayah Al Yaari, Sajedah Al Yaari

Abstract:

Objective: This research aims at investigating the research ethics in the field of science. Method: It is an exploratory research wherein the researchers attempted to cover the phenomenon at hand from all specialists’ viewpoints. Results Discussion is based upon the findings resulted from the analysis the researcher undertook. Concerning the results’ prediction, the researcher needs first to seek highly qualified people in the field of research as well as in the field of statistics who share the philosophy of the research. Then s/he should make sure that s/he is adequately trained in the specific techniques, methods and statically programs that are used at the study. S/he should also believe in continually analysis for the data in the most current methods.

Keywords: research ethics, legal, rights, psychoneurolinguistics

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26618 A Program of Data Analysis on the Possible State of the Antibiotic Resistance in Bangladesh Environment in 2019

Authors: S. D. Kadir

Abstract:

Background: Antibiotics have always been at the centrum of the revolution of modern microbiology. Micro-organisms and its pathogenicity, resistant organisms, inappropriate or over usage of various types of antibiotic agents are fuelled multidrug-resistant pathogenic organisms. Our present time review report mainly focuses on the therapeutic condition of antibiotic resistance and the possible roots behind the development of antibiotic resistance in Bangladesh in 2019. Methodology: The systemic review has progressed through a series of research analyses on various manuscripts published on Google Scholar, PubMed, Research Gate, and collected relevant information from established popular healthcare and diagnostic center and its subdivisions all over Bangladesh. Our research analysis on the possible assurance of antibiotic resistance been ensured by the selective medical reports and on random assay on the extent of individual antibiotic in 2019. Results: 5 research articles, 50 medical report summary, and around 5 patients have been interviewed while going through the estimation process. We have prioritized research articles where the research analysis been performed by the appropriate use of the Kirby-Bauer method. Kirby-Bauer technique is preferred as it provides greater efficiency, ensures lower performance expenditure, and supplies greater convenience and simplification in the application. In most of the reviews, clinical and laboratory standards institute guidelines were strictly followed. Most of our reports indicate significant resistance shown by the Beta-lactam drugs. Specifically by the derivatives of Penicillin's, Cephalosporin's (rare use of the first generation Cephalosporin and overuse of the second and third generation of Cephalosporin and misuse of the fourth generation of Cephalosporin), which are responsible for almost 67 percent of the bacterial resistance. Moreover, approximately 20 percent of the resistance was due to the fact of drug pumping from the bacterial cell by tetracycline and sulphonamides and their derivatives. Conclusion: 90 percent of the approximate antibiotic resistance is due to the usage of relative and true broad-spectrum antibiotics. The environment has been created by the following circumstances where; the excessive usage of broad-spectrum antibiotics had led to a condition where the disruption of native bacteria and a series of anti-microbial resistance causing a disturbance of the surrounding environments in medium, leading to a state of super-infection.

Keywords: antibiotics, antibiotic resistance, Kirby Bauer method, microbiology

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26617 Protocol for Consumer Research in Academia for Community Marketing Campaigns

Authors: Agnes J. Otjen, Sarah Keller

Abstract:

A Montana university has used applied consumer research in experiential learning with non-profit clients for over a decade. Through trial and error, a successful protocol has been established from problem statement through formative research to integrated marketing campaign execution. In this paper, we describe the protocol and its applications. Analysis was completed to determine the effectiveness of the campaigns and the results of how pre- and post-consumer research mark societal change because of media.

Keywords: consumer, research, marketing, communications

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26616 Stability Analysis of Two-delay Differential Equation for Parkinson's Disease Models with Positive Feedback

Authors: M. A. Sohaly, M. A. Elfouly

Abstract:

Parkinson's disease (PD) is a heterogeneous movement disorder that often appears in the elderly. PD is induced by a loss of dopamine secretion. Some drugs increase the secretion of dopamine. In this paper, we will simply study the stability of PD models as a nonlinear delay differential equation. After a period of taking drugs, these act as positive feedback and increase the tremors of patients, and then, the differential equation has positive coefficients and the system is unstable under these conditions. We will present a set of suggested modifications to make the system more compatible with the biodynamic system. When giving a set of numerical examples, this research paper is concerned with the mathematical analysis, and no clinical data have been used.

Keywords: Parkinson's disease, stability, simulation, two delay differential equation

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26615 Treatment of Non-Small Cell Lung Cancer (NSCLC) With Activating Mutations Considering ctDNA Fluctuations

Authors: Moiseenko F. V., Volkov N. M., Zhabina A. S., Stepanova E. O., Kirillov A. V., Myslik A. V., Artemieva E. V., Agranov I. R., Oganesyan A. P., Egorenkov V. V., Abduloeva N. H., Aleksakhina S. Yu., Ivantsov A. O., Kuligina E. S., Imyanitov E. N., Moiseyenko V. M.

Abstract:

Analysis of ctDNA in patients with NSCLC is an emerging biomarker. Multiple research efforts of quantitative or at least qualitative analysis before and during the first periods of treatment with TKI showed the prognostic value of ctDNA clearance. Still, these important results are not incorporated in clinical standards. We evaluated the role of ctDNA in EGFR-mutated NSCLC receiving first-line TKI. Firstly, we analyzed sequential plasma samples from 30 patients that were collected before intake of the first tablet (at baseline) and at 6, 12, 24, 36, and 48 hours after the “starting point.” EGFR-M+ allele was measured by ddPCR. Afterward, we included sequential qualitative analysis of ctDNA with cobas® EGFR Mutation Test v2 from 99 NSCLC patients before the first dose, after 2 and 4 months of treatment, and on progression. Early response analysis showed the decline of EGFR-M+ level in plasma within the first 48 hours of treatment in 11 subjects. All these patients showed objective tumor response. 10 patients showed either elevation of EGFR-M+ plasma concentration (n = 5) or stable content of circulating EGFR-M+ after the start of the therapy (n = 5); only 3 of these patients achieved an objective response (p = 0.026) when compared to the former group). The rapid decline of plasma EGFR-M+ DNA concentration also predicted for longer PFS (13.7 vs. 11.4 months, p = 0.030). Long-term ctDNA monitoring showed clinically significant heterogeneity of EGFR-mutated NSCLC treated with 1st line TKIs in terms of progression-free and overall survival. Patients without detectable ctDNA at baseline (N = 32) possess the best prognosis on the duration of treatment (PFS: 24.07 [16.8-31.3] and OS: 56.2 [21.8-90.7] months). Those who achieve clearance after two months of TKI (N = 42) have indistinguishably good PFS (19.0 [13.7 – 24.2]). Individuals who retain ctDNA after 2 months (N = 25) have the worst prognosis (PFS: 10.3 [7.0 – 13.5], p = 0.000). 9/25 patients did not develop ctDNA clearance at 4 months with no statistical difference in PFS from those without clearance at 2 months. Prognostic heterogeneity of EGFR-mutated NSCLC should be taken into consideration in planning further clinical trials and optimizing the outcomes of patients.

Keywords: NSCLC, EGFR, targeted therapy, ctDNA, prognosis

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26614 O-(2-18F-Fluoroethyl)-L-Tyrosine Positron Emission Tomography/Computed Tomography in Patients with Suspicious Recurrent Low and High-Grade Glioma

Authors: Mahkameh Asadi, Habibollah Dadgar

Abstract:

The precise definition margin of high and low-grade glioma is crucial for choosing best treatment approach after surgery and radio-chemotherapy. The aim of the current study was to assess the O-(2-18F-fluoroethyl)-L-tyrosine (18F-FET) positron emission tomography (PET)/computed tomography (CT) in patients with low (LGG) and high grade glioma (HGG). We retrospectively analyzed 18F-FET PET/CT of 10 patients (age: 33 ± 12 years) with suspicious for recurrent LGG and HGG. The final decision of recurrence was made by magnetic resonance imaging (MRI) and registered clinical data. While response to radio-chemotherapy by MRI is often complex and sophisticated due to the edema, necrosis, and inflammation, emerging amino acid PET leading to better interpretations with more specifically differentiate true tumor boundaries from equivocal lesions. Therefore, integrating amino acid PET in the management of glioma to complement MRI will significantly improve early therapy response assessment, treatment planning, and clinical trial design.

Keywords: positron emission tomography, amino acid positron emission tomography, magnetic resonance imaging, low and high grade glioma

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26613 An Alternative to Problem-Based Learning in a Post-Graduate Healthcare Professional Programme

Authors: Brogan Guest, Amy Donaldson-Perrott

Abstract:

The Master’s of Physician Associate Studies (MPAS) programme at St George’s, University of London (SGUL), is an intensive two-year course that trains students to become physician associates (PAs). PAs are generalized healthcare providers who work in primary and secondary care across the UK. PA programmes face the difficult task of preparing students to become safe medical providers in two short years. Our goal is to teach students to develop clinical reasoning early on in their studies and historically, this has been done predominantly though problem-based learning (PBL). We have had an increase concern about student engagement in PBL and difficulty recruiting facilitators to maintain the low student to facilitator ratio required in PBL. To address this issue, we created ‘Clinical Application of Anatomy and Physiology (CAAP)’. These peer-led, interactive, problem-based, small group sessions were designed to facilitate students’ clinical reasoning skills. The sessions were designed using the concept of Team-Based Learning (TBL). Students were divided into small groups and each completed a pre-session quiz consisting of difficult questions devised to assess students’ application of medical knowledge. The quiz was completed in small groups and they were not permitted access of external resources. After the quiz, students worked through a series of openended, clinical tasks using all available resources. They worked at their own pace and the session was peer-led, rather than facilitator-driven. For a group of 35 students, there were two facilitators who observed the sessions. The sessions utilised an infinite space whiteboard software. Each group member was encouraged to actively participate and work together to complete the 15-20 tasks. The session ran for 2 hours and concluded with a post-session quiz, identical to the pre-session quiz. We obtained subjective feedback from students on their experience with CAAP and evaluated the objective benefit of the sessions through the quiz results. Qualitative feedback from students was generally positive with students feeling the sessions increased engagement, clinical understanding, and confidence. They found the small group aspect beneficial and the technology easy to use and intuitive. They also liked the benefit of building a resource for their future revision, something unique to CAAP compared to PBL, which out students participate in weekly. Preliminary quiz results showed improvement from pre- and post- session; however, further statistical analysis will occur once all sessions are complete (final session to run December 2022) to determine significance. As a post-graduate healthcare professional programme, we have a strong focus on self-directed learning. Whilst PBL has been a mainstay in our curriculum since its inception, there are limitations and concerns about its future in view of student engagement and facilitator availability. Whilst CAAP is not TBL, it draws on the benefits of peer-led, small group work with pre- and post- team-based quizzes. The pilot of these sessions has shown that students are engaged by CAAP, and they can make significant progress in clinical reasoning in a short amount of time. This can be achieved with a high student to facilitator ratio.

Keywords: problem based learning, team based learning, active learning, peer-to-peer teaching, engagement

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26612 A Comparison of Three Protocols Weight-Loss Interventions for Obese Females

Authors: Nayera E. Hassan, Sahar A. El-Masry, Rokia El-Banna, Mohamed S. El Hussieny

Abstract:

There are several different modalities for treatment of obesity. Common intervention methods for obesity include low-calorie diet, exercise. Also acupuncture has shown good therapeutic results in the treatment of obesity. A recent clinical observation showed that laser acupuncture could reduce body weight and body mass index in obese persons. So, the aim of this research is focused on body composition changes as related to type of intervention, before and after intentional weight loss in overweight and obesity. 76 subjects were included in the study analysis. The present study recommended that every obese female must do lipid profile and fasting blood sugar analysis before weight-loss intervention to take the decision of which method should be used.

Keywords: obesity, weight-loss, body composition, modalities

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26611 Relationship of Oxidative Stress to Elevated Homocysteine and DNA Damage in Coronary Artery Disease Patients

Authors: Shazia Anwer Bukhari, Madiha Javeed Ghani, Muhammad Ibrahim Rajoka

Abstract:

Objective: Biochemical, environmental, physical and genetic factors have a strong effect on the development of coronary disease (CAD). Plasma homocysteine (Hcy) level and DNA damage play a pivotal role in its development and progression. The aim of this study was to investigate the predictive strength of an oxidative stress, clinical biomarkers and total antioxidant status (TAS) in CAD patients to find the correlation of homocysteine, TOS and oxidative DNA damage with other clinical parameters. Methods: Sixty confirmed patients with CAD and 60 healthy individuals as control were included in this study. Different clinical and laboratory parameters were studied in blood samples obtained from patients and control subjects using commercially available biochemical kits and statistical software Results: As compared to healthy individuals, CAD patients had significantly higher concentrations of indices of oxidative stress: homocysteine (P=0.0001), total oxidative stress (TOS) (P=0.0001), serum cholesterol (P=0.04), low density lipoprotein cholesterol (LDL) (P=0.01), high density lipoprotein-cholesterol (HDL) (P=0.0001), and malondialdehyde (MDA) (P=0.001) than those of healthy individuals. Plasma homocysteine level and oxidative DNA damage were positively correlated with cholesterol, triglycerides, systolic blood pressure, urea, total protein and albumin (P values= 0.05). Both Hcy and oxidative DNA damage were negatively correlated with TAS and proteins. Conclusion: Coronary artery disease patients had a significant increase in homocysteine level and DNA damage due to increased oxidative stress. In conclusion, our study shows a significantly increase in lipid peroxidation, TOS, homocysteine and DNA damage in the erythrocytes of patients with CAD. A significant decrease level of HDL-C and TAS was observed only in CAD patients. Therefore these biomarkers may be useful diagnosis of patients with CAD and play an important role in the pathogenesis of CAD.

Keywords: antioxidants, coronary artery disease, DNA damage, homocysteine, oxidative stress, malondialdehyde, 8-Hydroxy-2’deoxyguanosine

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26610 Pyridoxine Effectiveness and Safety for Postpartum Lactation Inhibition: A Systematic Review

Authors: Doua AlSaad, Ahmed Awaisu, Samah Elsalem, Palli Valapila Abdulrouf, Binny Thomas, Moza AlHail

Abstract:

Background: It has been suggested that pyridoxine has an anti-lactogenic effect. Studies of the efficacy of pyridoxine in suppressing lactation have reported conflicting results. The aim of this review is to evaluate the effectiveness and safety of high-dose pyridoxine in postpartum lactation inhibition. Methods: This systematic review included published trials that compared the efficacy and/or safety of pyridoxine to placebo or to other pharmacological agents for the inhibition of postpartum lactation. We searched PubMed, Embase, ScienceDirect, CINAHL, AMED, the Cochrane library, and the clinical trials registry to identify relevant literature. No limit was imposed on the year of publication of the studies, and the review included studies published until 15 January 2016. Two reviewers independently extracted data and assessed the risk of bias. Results: Seven studies were included, with a total of 1155 women, of which 471 women received pyridoxine. Three studies were randomized controlled trials, while the remaining four studies were non-randomized controlled trials. All of the included studies were relatively small (n = 18 – 482). The studies compared pyridoxine with placebo, bromocriptine, and/or stilboestrol. Pyridoxine was given orally, with a total daily dose of 450 – 600 mg for 5 to 7 days. Two trials (n = 349 participants) indicated that pyridoxine was effective in inhibiting lactation in approximately 95% of the enrolled patients. All other studies failed to demonstrate pyridoxine efficacy through either clinical assessment or prolactin level measurements. Pyridoxine safety was assessed by two trials in which no serious untoward side-effects were reported. Overall, the risk of bias for most of the studies was low to moderate. Conclusion: Current evidence supporting the effectiveness of high dose pyridoxine in the inhibition of postpartum lactation is inconsistent and insufficient. Larger randomized trials are needed to confirm the efficacy of pyridoxine in postpartum lactation inhibition. Acknowledgment: This review received a grant from the Medical Research Center of Hamad Medical Corporation in Qatar (grant number: 15100/15).

Keywords: pyridoxine, safety, effectiveness, lactation inhibition

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26609 Multicenter Evaluation of the ACCESS HBsAg and ACCESS HBsAg Confirmatory Assays on the DxI 9000 ACCESS Immunoassay Analyzer, for the Detection of Hepatitis B Surface Antigen

Authors: Vanessa Roulet, Marc Turini, Juliane Hey, Stéphanie Bord-Romeu, Emilie Bonzom, Mahmoud Badawi, Mohammed-Amine Chakir, Valérie Simon, Vanessa Viotti, Jérémie Gautier, Françoise Le Boulaire, Catherine Coignard, Claire Vincent, Sandrine Greaume, Isabelle Voisin

Abstract:

Background: Beckman Coulter, Inc. has recently developed fully automated assays for the detection of HBsAg on a new immunoassay platform. The objective of this European multicenter study was to evaluate the performance of the ACCESS HBsAg and ACCESS HBsAg Confirmatory assays† on the recently CE-marked DxI 9000 ACCESS Immunoassay Analyzer. Methods: The clinical specificity of the ACCESS HBsAg and HBsAg Confirmatory assays was determined using HBsAg-negative samples from blood donors and hospitalized patients. The clinical sensitivity was determined using presumed HBsAg-positive samples. Sample HBsAg status was determined using a CE-marked HBsAg assay (Abbott ARCHITECT HBsAg Qualitative II, Roche Elecsys HBsAg II, or Abbott PRISM HBsAg assay) and a CE-marked HBsAg confirmatory assay (Abbott ARCHITECT HBsAg Qualitative II Confirmatory or Abbott PRISM HBsAg Confirmatory assay) according to manufacturer package inserts and pre-determined testing algorithms. False initial reactive rate was determined on fresh hospitalized patient samples. The sensitivity for the early detection of HBV infection was assessed internally on thirty (30) seroconversion panels. Results: Clinical specificity was 99.95% (95% CI, 99.86 – 99.99%) on 6047 blood donors and 99.71% (95%CI, 99.15 – 99.94%) on 1023 hospitalized patient samples. A total of six (6) samples were found false positive with the ACCESS HBsAg assay. None were confirmed for the presence of HBsAg with the ACCESS HBsAg Confirmatory assay. Clinical sensitivity on 455 HBsAg-positive samples was 100.00% (95% CI, 99.19 – 100.00%) for the ACCESS HBsAg assay alone and for the ACCESS HBsAg Confirmatory assay. The false initial reactive rate on 821 fresh hospitalized patient samples was 0.24% (95% CI, 0.03 – 0.87%). Results obtained on 30 seroconversion panels demonstrated that the ACCESS HBsAg assay had equivalent sensitivity performances compared to the Abbott ARCHITECT HBsAg Qualitative II assay with an average bleed difference since first reactive bleed of 0.13. All bleeds found reactive in ACCESS HBsAg assay were confirmed in ACCESS HBsAg Confirmatory assay. Conclusion: The newly developed ACCESS HBsAg and ACCESS HBsAg Confirmatory assays from Beckman Coulter have demonstrated high clinical sensitivity and specificity, equivalent to currently marketed HBsAg assays, as well as a low false initial reactive rate. †Pending achievement of CE compliance; not yet available for in vitro diagnostic use. 2023-11317 Beckman Coulter and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. All other trademarks are the property of their respective owners.

Keywords: dxi 9000 access immunoassay analyzer, hbsag, hbv, hepatitis b surface antigen, hepatitis b virus, immunoassay

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26608 Perception and Attitudes of Medical Students towards Dermatology as a Future Specialty.

Authors: Rakan Alajmi, Rahaf Alnazzawi, Yara Aljefri, Abdullah Alafif, Ali Alraddadi, Awadh Alamri

Abstract:

Background: The distribution of physicians in different specialties across Saudi Arabia is determined by the career choices of medical students. Dermatology residency program is one of the highly competitive programs here in Saudi Arabia. Assessing and understanding the factors perceived to be attractive in choosing dermatology will aid the directors of the specialty programs to plan for a more balanced workforce distribution to better suit the needs of the specialties. Aim: The aim of our study is to determine and assess the factors perceived to be significantly attractive when choosing dermatology as a future specialty. Methods: The study is a cross-sectional study conducted in King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. A validated questionnaire was sent electronically to clinical year medical students. In addition to the questionnaire, gender, grade point average, preferred specialty, and other socio-demographic data were assessed. Results: A total of 121 clinical years medical students completed the questionnaire, 8 (6.6%) preferred dermatology as a specialty. 76 (62.8%) of the participants score a grade point average of more than 4.5 and 83 students (68.6%) chose their specialty during clinical years. The appeal of being a dermatologist (P= 0.047), the portrayal of different specialities in the media (P= 0.005), and the likelihood that dermatologists can influence patients’ lives (P=0.010) were shown to be significantly attractive factors. Conclusion: There are many factors that are affecting students’ choices when choosing a medical specialty. The appeal of being a dermatologist, the portrayal of different specialities in the media, and the likelihood that dermatologists can influence patients’ lives were shown to be significantly attractive factors when choosing dermatology as a future specialty. Recognizing medical students’ specialty perception will lead them to a proper specialty tailored to their needs.

Keywords: dermatology, career choice, medical specialties, student's perception

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26607 Mapping a Data Governance Framework to the Continuum of Care in the Active Assisted Living Context

Authors: Gaya Bin Noon, Thoko Hanjahanja-Phiri, Laura Xavier Fadrique, Plinio Pelegrini Morita, Hélène Vaillancourt, Jennifer Teague, Tania Donovska

Abstract:

Active Assisted Living (AAL) refers to systems designed to improve the quality of life, aid in independence, and create healthier lifestyles for care recipients. As the population ages, there is a pressing need for non-intrusive, continuous, adaptable, and reliable health monitoring tools to support aging in place. AAL has great potential to support these efforts with the wide variety of solutions currently available, but insufficient efforts have been made to address concerns arising from the integration of AAL into care. The purpose of this research was to (1) explore the integration of AAL technologies and data into the clinical pathway, and (2) map data access and governance for AAL technology in order to develop standards for use by policy-makers, technology manufacturers, and developers of smart communities for seniors. This was done through four successive research phases: (1) literature search to explore existing work in this area and identify lessons learned; (2) modeling of the continuum of care; (3) adapting a framework for data governance into the AAL context; and (4) interviews with stakeholders to explore the applicability of previous work. Opportunities for standards found in these research phases included a need for greater consistency in language and technology requirements, better role definition regarding who can access and who is responsible for taking action based on the gathered data, and understanding of the privacy-utility tradeoff inherent in using AAL technologies in care settings.

Keywords: active assisted living, aging in place, internet of things, standards

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26606 Finite Element Analysis of Shape Memory Alloy Stents in Coronary Arteries

Authors: Amatulraheem Al-Abassi, K. Khanafer, Ibrahim Deiab

Abstract:

The coronary artery stent is a promising technology that can treat various coronary diseases. Materials used for manufacturing medical stents should have high biocompatible properties. Stent alloys, in particular, are remarkably promising good clinical outcomes, however, there is threaten of restenosis (reoccurring of artery narrowing due to fatty plaque), stent recoiling, or in long-term the occurrence of stent fracture. However, stents that are made of Nickel-titanium (Nitinol) can bare extensive plastic deformation and resist restenosis. This shape memory alloy has outstanding mechanical properties. Nitinol is a unique shape memory alloy as it has unique mechanical properties such as; biocompatibility, super-elasticity, and recovery to original shape under certain loads. Stent failure may cause complications in vascular diseases and possibly blockage of blood flow. Thus, studying the behaviors of the stent under different medical conditions will help the doctors and cardiologists to predict when it is necessary to change the stent in order to prevent any severe morbidity outcomes. To the best of our knowledge, there are limited published papers that analyze the stent behavior with regards to the contact surfaces of plaque layer and blood vessel. Thus, stent material properties will be discussed in this investigation to highlight the mechanical and clinical differences between various stents. This research analyzes the performance of Nitinol stent in well-known stent design to determine its bearing with stress and its dislocation in blood vessels, in comparison to stents made of different biocompatible materials. In addition, a study of its performance will be represented in the system. Finite Element Analysis is the core of this study. Thus, a physical representative model will be discussed to show the distribution of stress and strain along the interaction surface between the stent and the artery. The reaction of vascular tissue to the stent will be evaluated to predict the possibility of restenosis within the treated area.

Keywords: shape memory alloy, stent, coronary artery, finite element analysis

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