Search results for: retrospective study
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 48333

Search results for: retrospective study

48123 Drugs, Silk Road, Bitcoins

Authors: Lali Khurtsia, Vano Tsertsvadze

Abstract:

Georgian drug policy is directed to reduce the supply of drugs. Retrospective analysis has shown that law enforcement activities have been followed by the expulsion of particular injecting drugs. The demand remains unchanged and drugs are substituted by the hand-made, even more dangerous homemade drugs entered the market. To find out expected new trends on the Georgian drug market, qualitative study was conducted with Georgian drug users to determine drug supply routes. It turned out that drug suppliers and consumers for safety reasons and to protect their anonymity, use Skype to make deals. IT in illegal drug trade is even more sophisticated in the worldwide. Trading with Bitcoins in the Darknet ensures high confidentiality of money transactions and the safe circulation of drugs. In 2014 largest Bitcoin mining enterprise in the world was built in Georgia. We argue that the use of Bitcoins and Darknet by Georgian drug consumers and suppliers will be an incentive to response adequately to the government's policy of restricting supply in order to satisfy market demand for drugs.

Keywords: bitcoin, darknet, drugs, policy

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48122 Outcome of Using Penpat Pinyowattanasilp Equation for Prediction of 24-Hour Uptake, First and Second Therapeutic Doses Calculation in Graves’ Disease Patient

Authors: Piyarat Parklug, Busaba Supawattanaobodee, Penpat Pinyowattanasilp

Abstract:

The radioactive iodine thyroid uptake (RAIU) has been widely used to differentiate the cause of thyrotoxicosis and treatment. Twenty-four hours RAIU is routinely used to calculate the dose of radioactive iodine (RAI) therapy; however, 2 days protocol is required. This study aims to evaluate the modification of Penpat Pinyowattanasilp equation application by the exclusion of outlier data, 3 hours RAIU less than 20% and more than 80%, to improve prediction of 24-hour uptake. The equation is predicted 24 hours RAIU (P24RAIU) = 32.5+0.702 (3 hours RAIU). Then calculating separation first and second therapeutic doses in Graves’ disease patients. Methods; This study was a retrospective study at Faculty of Medicine Vajira Hospital in Bangkok, Thailand. Inclusion were Graves’ disease patients who visited RAI clinic between January 2014-March 2019. We divided subjects into 2 groups according to first and second therapeutic doses. Results; Our study had a total of 151 patients. The study was done in 115 patients with first RAI dose and 36 patients with second RAI dose. The P24RAIU are highly correlated with actual 24-hour RAIU in first and second therapeutic doses (r = 0.913, 95% CI = 0.876 to 0.939 and r = 0.806, 95% CI = 0.649 to 0.897). Bland-Altman plot shows that mean differences between predictive and actual 24 hours RAI in the first dose and second dose were 2.14% (95%CI 0.83-3.46) and 1.37% (95%CI -1.41-4.14). The mean first actual and predictive therapeutic doses are 8.33 ± 4.93 and 7.38 ± 3.43 milliCuries (mCi) respectively. The mean second actual and predictive therapeutic doses are 6.51 ± 3.96 and 6.01 ± 3.11 mCi respectively. The predictive therapeutic doses are highly correlated with the actual dose in first and second therapeutic doses (r = 0.907, 95% CI = 0.868 to 0.935 and r = 0.953, 95% CI = 0.909 to 0.976). Bland-Altman plot shows that mean difference between predictive and actual P24RAIU in the first dose and second dose were less than 1 mCi (-0.94 and -0.5 mCi). This modification equation application is simply used in clinical practice especially patient with 3 hours RAIU in range of 20-80% in a Thai population. Before use, this equation for other population should be tested for the correlation.

Keywords: equation, Graves’disease, prediction, 24-hour uptake

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48121 Exploring the Safety of Sodium Glucose Co-Transporter-2 Inhibitors at the Imperial College London Diabetes Centre, UAE

Authors: Raad Nari, Maura Moriaty, Maha T. Barakat

Abstract:

Introduction: Sodium-glucose co-transporter-2 (SGLT2) inhibitors are a new class of oral anti-diabetic drugs with a unique mechanism of action. They are used to improve glycaemic control in adults with type 2 diabetes by enhancing urinary glucose excretion. In the UAE, there has been certainly an increased use of these medications. As with any new medication, there are safety considerations related to their use in patients with type two diabetes. A retrospective study was conducted at the three main centres of the Imperial College London Diabetes Centre. Methodology: All patients in electronic database (Diamond) from October 2014 to October 2017 were included with a minimum of six months usage of sodium glucose co-transporter inhibitors that comprise canagliflozin, dapagliflozin and empagliflozin. There were 15 paired sample biochemical and clinical correlations. The analysis was done at the start of the study, three months and six months apart. SPSS version 24 was used for this study. Conclusion: This study of sodium glucose co-transporter-2 inhibitors used showed significant reductions in weight, glycated haemoglobin A1C, systolic and diastolic blood pressures. As the case with systematic reviews, there were similar changes in liver enzymes, raised total cholesterol, low density lipopoptein and high density lipoprotein. There was slight improvement in estimated glomerular filtration rate too. Our analysis also showed that they increased in the incidence of urinary tract symptoms and incidence of urinary tract infections.

Keywords: SGLT2 inhibitors dapagliflozin empagliflozin canagliflozin, adverse effects, amputation diabetic ketoacidosis DKA, urinary tract infection

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48120 Outcomes of Combined Penetrating keratoplasty and Vitreo-Retinal Surgery in Management of Endophthalmitis with Obscured Corneal Clarity

Authors: Abhishek Dave, Manisha Singh

Abstract:

Purpose: The study aims to evaluate the outcomes of combined Penetrating keratoplasty (PKP) and Vitreo-Retinal (VR) surgery in patients having endophthalmitis with poor corneal clarity. Methods: PKP with VR Surgery was performed in 43 eyes. This is a retrospective analysis of their preoperative, intraoperative and microbiological characteristics and anatomical and functional outcomes. Results: Corneal opacification was due to corneal ulcer in 30 (69.7%), graft infection in 8 (18.6%), bullous keratopathy in 4 and corneal scar in 1 eye. Postoperative visual acuity improved in 20 (46.5%), not changed in 14 (32.5%) and deteriorated in 9 eyes (20.9%). Poor anatomic success was seen in 15 (34.88%) eyes (9-phthisis bulbi, 6-eviscerated). Graft remained clear in 24 eyes (1 year). Microbiology revealed bacteria in 26, fungus in 14 and no growth in 3 eyes. Six out of 11 patients having poor vision in the fellow eye, too, achieved functional success. Conclusion: PKP with VR surgery is a complex but globe-salvaging procedure for poor prognosis eyes, which otherwise would need evisceration.

Keywords: penetrating keratoplasty, VR surgery, endophthalmitis, corneal ulcer

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48119 Conduction System Disease and Atrioventricular Block in Victims of COVID-19

Authors: Shirin Sarejloo

Abstract:

Background: Electrophysiological-related manifestation of COVID-19 is a matter of debate in the literature nowadays. A wide spectrum of arrhythmias was observed among patients who have been infected with COVID-19. Objectives: This study discussed the prevalence of arrhythmias and conduction system disease in patients with COVID-19. Method: In this retrospective study, demographic and electrocardiographic data of 432 expired COVID-19 patients who had been admitted to Faghihi Hospital of Shiraz University of Medical Sciences from August2020 until December 2020 were reviewed. Results: Atrioventricular nodal block (AVB) was found in 40(9.3%) patients. Furthermore, 28(6.5%) of them suffered from the first degree of AVB, and 12(2.8%) suffered from complete heart block (CHB). Among 189 cases (59.0%), ST-T changes agreed with myocardial infarction or localized myocarditis. Findings of myocardial injury, including fragmented QRS and prolonged QTc were observed among 91 (21.1%) and 28 (6.5%), respectively. In victims of COVID-19, conduction disease was not related to any comorbidities. Fragmented QRS, axis deviation, presence of S1Q3T3, and poor R wave progression were significantly related to conduction system abnormalities in victims of COVID-19 (P-value > 0.05). Conclusion: Our findings can serve in future studies that aim to develop a risk stratification method for susceptible COVID-19 patients. The myocardial injury appears to role significantly in COVID-19 morbidity and mortality. Consequently, we recommend health policymakers consider separate catheterization laboratories that provide service only to COVID-19 patients.

Keywords: COVID-19, conduction system, ECG, atrioventricular block

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48118 Correlation Between Different Radiological Findings and Histopathological diagnosis of Breast Diseases: Retrospective Review Conducted Over Sixth Years in King Fahad University Hospital in Eastern Province, Saudi Arabia

Authors: Sadeem Aljamaan, Reem Hariri, Rahaf Alghamdi, Batool Alotaibi, Batool Alsenan, Lama Althunayyan, Areej Alnemer

Abstract:

The aim of this study is to correlate between radiological findings and histopathological results in regard to the breast imaging-reporting and data system scores, size of breast masses, molecular subtypes and suspicious radiological features, as well as to assess the concordance rate in histological grade between core biopsy and surgical excision among breast cancer patients, followed by analyzing the change of concordance rate in relation to neoadjuvant chemotherapy in a Saudi population. A retrospective review was conducted over 6-year period (2017-2022) on all breast core biopsies of women preceded by radiological investigation. Chi-squared test (χ2) was performed on qualitative data, the Mann-Whitney test for quantitative non-parametric variables, and the Kappa test for grade agreement. A total of 641 cases were included. Ultrasound, mammography, and magnetic resonance imaging demonstrated diagnostic accuracies of 85%, 77.9% and 86.9%; respectively. magnetic resonance imaging manifested the highest sensitivity (72.2%), and the lowest was for ultrasound (61%). Concordance in tumor size with final excisions was best in magnetic resonance imaging, while mammography demonstrated a higher tendency of overestimation (41.9%), and ultrasound showed the highest underestimation (67.7%). The association between basal-like molecular subtypes and the breast imaging-reporting and data system score 5 classifications was statistically significant only for magnetic resonance imaging (p=0.04). Luminal subtypes demonstrated a significantly higher percentage of speculation in mammography. Breast imaging-reporting and data system score 4 manifested a substantial number of benign pathologies in all the 3 modalities. A fair concordance rate (k= 0.212 & 0.379) was demonstrated between excision and the preceding core biopsy grading with and without neoadjuvant therapy, respectively. The results demonstrated a down-grading in cases post-neoadjuvant therapy. In cases who did not receive neoadjuvant therapy, underestimation of tumor grade in biopsy was evident. In summary, magnetic resonance imaging had the highest sensitivity, specificity, positive predictive value and accuracy of both diagnosis and estimation of tumor size. Mammography demonstrated better sensitivity than ultrasound and had the highest negative predictive value, but ultrasound had better specificity, positive predictive value and accuracy. Therefore, the combination of different modalities is advantageous. The concordance rate of core biopsy grading with excision was not impacted by neoadjuvant therapy.

Keywords: breast cancer, mammography, MRI, neoadjuvant, pathology, US

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48117 Pre-Malignant Breast Lesions, Methods of Treatment and Outcome

Authors: Ahmed Mostafa, Mohamed Mahmoud, Nesreen H. Hafez, Mohamed Fahim

Abstract:

This retrospective study includes 60 patients with pre-invasive breast cancer. Aim of the study: Evaluation of premalignant lesions of the breast (DCIS), different treatment methods and outcome. Patients and methods: 60 patients with DCIS were studied from the period between 2005 to 2012, for 38 patients the primary surgical method was wide local resection (WLE) (63.3%) and the other cases (22 patients, 36.7%) had mastectomy, fourteen cases from those who underwent local excision received radiotherapy, while no adjuvant radiotherapy was given for those who underwent mastectomy. In case of hormonal receptor positive DCIS lesions hormonal treatment (Tamoxifen) was given after local control. Results: No difference in overall survival between mastectomy & breast conserving therapy (wide local excision and adjuvant radiotherapy), however local recurrence rate is higher in case of breast conserving therapy, also no role of Axillary evacuation in case of DCIS. The use of hormonal therapy decreases the incidence of local recurrence by about 98%. Conclusion: The main management of DCIS is local treatment (wide local excision and radiotherapy) with hormonal treatment in case of hormone receptor positive lesions.

Keywords: ductal carcinoma in situ, surgical treatment, radiotherapy, breast conserving therapy, hormonal treatment

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48116 Breast Cancer Mortality and Comorbidities in Portugal: A Predictive Model Built with Real World Data

Authors: Cecília M. Antão, Paulo Jorge Nogueira

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Breast cancer (BC) is the first cause of cancer mortality among Portuguese women. This retrospective observational study aimed at identifying comorbidities associated with BC female patients admitted to Portuguese public hospitals (2010-2018), investigating the effect of comorbidities on BC mortality rate, and building a predictive model using logistic regression. Results showed that the BC mortality in Portugal decreased in this period and reached 4.37% in 2018. Adjusted odds ratio indicated that secondary malignant neoplasms of liver, of bone and bone marrow, congestive heart failure, and diabetes were associated with an increased chance of dying from breast cancer. Although the Lisbon district (the most populated area) accounted for the largest percentage of BC patients, the logistic regression model showed that, besides patient’s age, being resident in Bragança, Castelo Branco, or Porto districts was directly associated with an increase of the mortality rate.

Keywords: breast cancer, comorbidities, logistic regression, adjusted odds ratio

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48115 Clinical and Laboratory Diagnosis of Malaria in Surat Thani, Southern Thailand

Authors: Manas Kotepui, Chatree Ratcha, Kwuntida Uthaisar

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Malaria infection is still to be considered a major public health problem in Thailand. This study, a retrospective data of patients in Surat Thani Province, Southern Thailand during 2012-2015 was retrieved and analyzed. These data include demographic data, clinical characteristics and laboratory diagnosis. Statistical analyses were performed to demonstrate the frequency, proportion, data tendency, and group comparisons. Total of 395 malaria patients were found. Most of patients were male (253 cases, 64.1%). Most of patients (262 cases, 66.3%) were admitted at 6 am-11.59 am of the day. Three hundred and fifty-five patients (97.5%) were positive with P. falciparum. Hemoglobin, hematocrit, and MCHC between P. falciparum and P. vivax were significant different (P value<0.05).During 2012-2015, prevalence of malaria was highest in 2013. Neutrophils, lymphocytes, and monocytes were significantly changed among patients with fever ≤ 3 days compared with patients with fever >3 days. This information will guide to understanding pathogenesis and characteristic of malaria infection in Sothern Thailand.

Keywords: prevalence, malaria, Surat Thani, Thailand

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48114 Association Between Hip Internal and External Rotation Range of Motion and Low Back Pain in Table Tennis Players

Authors: Kaili Wang, Botao Zhang, Enming Zhang

Abstract:

Background: Low back pain (LBP) is a common problem affecting athletes' training and competition. Although the association between a limited hip range of motion and prevalence of low back pain has been studied extensively, it has not been studied in table tennis. Aim: The main purposes of this study in table tennis players were (1) to investigate if there is a difference in hip internal rotation (HIR) and external rotation (HER) range of motion (ROM) between players with LBP and players without LBP and (2) to analyze the association between HIR and HER ROM and LBP. Methods: Forty-six table tennis players from the Chinese table tennis team were evaluated for passive maximum HIR and HER ROM. LBP was retrospectively recorded for the last 12 months before the date of ROM assessment by a physical therapist. The data were analyzed the difference in HIR and HER ROM between players with LBP and players without LBP by Mann-Whitney U test, and the association between the difference in HIR and HER ROM and LBP was analyzed via a binary logistic regression. Results: The 54% of players had developed LBP during the retrospective study period. Significant difference between LBP group and the asymptomatic group for HIR ROM (z=4.007, p<0.001) was observed. Difference between LBP group and asymptomatic group for HER ROM (z=1.117, p=0.264) was not significant. Players who had HIR ROM deficit had an increased risk of LBP compared with players without HIR ROM deficit (OR=5.344, 95%CI: 1.006-28.395, P=0.049). Conclusion: HIR ROM of a table tennis player with LBP was less than a table tennis player without LBP. Compared with player whose HIR ROM was normal, player who had HIR ROM deficit appeared to have a higher risk for LBP.

Keywords: assessment, injury prevention, low back pain, table tennis players

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48113 Modern Cardiac Surgical Outcomes in Nonagenarians: A Multicentre Retrospective Observational Study

Authors: Laurence Weinberg, Dominic Walpole, Dong-Kyu Lee, Michael D’Silva, Jian W. Chan, Lachlan F. Miles, Bradley Carp, Adam Wells, Tuck S. Ngun, Siven Seevanayagam, George Matalanis, Ziauddin Ansari, Rinaldo Bellomo, Michael Yii

Abstract:

Background: There have been multiple recent advancements in the selection, optimization and management of cardiac surgical patients. However, there is limited data regarding the outcomes of nonagenarians undergoing cardiac surgery, despite this vulnerable cohort increasingly receiving these interventions. This study describes the patient characteristics, management and outcomes of a group of nonagenarians undergoing cardiac surgery in the context of contemporary peri-operative care. Methods: A retrospective observational study was conducted of patients 90 to 99 years of age (i.e., nonagenarians) who had undergone cardiac surgery requiring a classic median sternotomy (i.e., open-heart surgery). All operative indications were included. Patients who underwent minimally invasive surgery, transcatheter aortic valve implantation and thoracic aorta surgery were excluded. Data were collected from four hospitals in Victoria, Australia, over an 8-year period (January 2012 – December 2019). The primary objective was to assess six-month mortality in nonagenarians undergoing open-heart surgery and to evaluate the incidence and severity of postoperative complications using the Clavien-Dindo classification system. The secondary objective was to provide a detailed description of the characteristics and peri-operative management of this group. Results: A total of 12,358 adult patients underwent cardiac surgery at the study centers during the observation period, of whom 18 nonagenarians (0.15%) fulfilled the inclusion criteria. The median (IQR) [min-max] age was 91 years (90.0:91.8) [90-94] and 14 patients (78%) were men. Cardiovascular comorbidities, polypharmacy and frailty, were common. The median (IQR) predicted in-hospital mortality by EuroSCORE II was 6.1% (4.1-14.5). All patients were optimized preoperatively by a multidisciplinary team of surgeons, cardiologists, geriatricians and anesthetists. All index surgeries were performed on cardiopulmonary bypass. Isolated coronary artery bypass grafting (CABG) and CABG with aortic valve replacement were the most common surgeries being performed in four and five patients, respectively. Half the study group underwent surgery involving two or more major procedures (e.g. CABG and valve replacement). Surgery was undertaken emergently in 44% of patients. All patients except one experienced at least one postoperative complication. The most common complications were acute kidney injury (72%), new atrial fibrillation (44%) and delirium (39%). The highest Clavien-Dindo complication grade was IIIb occurring once each in three patients. Clavien-Dindo grade IIIa complications occurred in only one patient. The median (IQR) postoperative length of stay was 11.6 days (9.8:17.6). One patient was discharged home and all others to an inpatient rehabilitation facility. Three patients had an unplanned readmission within 30 days of discharge. All patients had follow-up to at least six months after surgery and mortality over this period was zero. The median (IQR) duration of follow-up was 11.3 months (6.0:26.4) and there were no cases of mortality observed within the available follow-up records. Conclusion: In this group of nonagenarians undergoing cardiac surgery, postoperative six-month mortality was zero. Complications were common but generally of low severity. These findings support carefully selected nonagenarian patients being offered cardiac surgery in the context of contemporary, multidisciplinary perioperative care. Further, studies are needed to assess longer-term mortality and functional and quality of life outcomes in this vulnerable surgical cohort.

Keywords: cardiac surgery, mortality, nonagenarians, postoperative complications

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48112 Pattern of Bacterial Isolates and Antimicrobial Resistance at Ayder Comprehensive Specialized Referral Hospital in Northern Ethiopia: A Retrospective Study

Authors: Solomon Gebremariam, Mulugeta Naizigi, Aregawi Haileselassie

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Background: Knowledge of the pattern of bacterial isolates and their antimicrobial susceptibility is crucial for guiding empirical treatment and infection prevention and control measures. Objective: The aim of this study was to analyze the pattern of bacterial isolates and their susceptibility patterns from various specimens. Methods: Retrospectively, a total of 1067 microbiological culture results that were isolated, characterized, and identified by standard microbiological methods and whose antibiotic susceptibility was determined using CLSI guidelines between 2017 and 2019 were retrieved and analyzed. Data were entered and analyzed using the Stata release 10.1 statistical package. Result: The positivity rate of culture was 26.04% (419/1609). The most common bacteria isolated were S. aureus 23.8% (94), E. coli 15.1% (60), Klebsiella pneumonia 14.1% (56), Pseudomonas aeruginosa 8.5% (34), and CONS 7.3% (29). S. aureus and CONS showed a high (58.1% - 96.2%) rate of resistance to most antibiotics tested. They were less resistant to Vancomycin which is 18.6% (13/70) and 11.8% (2/17), respectively. Similarly, the resistance of E. coli, Klebsella pneumonia, and Pseudomonas aeruginosa was high (69.4% - 100%) to most antibiotics. They were less resistant to Ciprofloxacilin, which is 41.1% (23/56), 19.2% (10/52), and 16.1% (5/31), respectively. Conclusion: This study has shown that there is a high rate of antibiotic resistance among bacterial isolates in this hospital. A combination of Vancomycin and Ciprofloxacin should be considered in the choice of antibiotics for empirical treatment of suspected infections due to S. aureus, CONS, E. coli, Klebsiella pneumonia, Pseudomonas such as in infections within hospital setup.

Keywords: antimicrobial, resistance, bacteria, hospital

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48111 Effects of Tenefovir Disiproxil Fumarate on the Renal Sufficiency of HIV Positive Patients

Authors: Londeka Ntuli, Frasia Oosthuizen

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Background: Tenefovir disiproxil fumarate (TDF) is a nephrotoxic drug and has been proven to contribute to renal insufficiency necessitating intensive monitoring and management of adverse effects arising from prolonged exposure to the drug. TDF is one of the preferred first-line drugs used in combination therapy in most regions. There are estimated 300 000 patients being initiated on the Efavirenz/TDF/Emtricitabine first-line regimen annually in South Africa. It is against this background that this study aims to investigate the effects of TDF on renal sufficiency of HIV positive patients. Methodology: A retrospective quantitative study was conducted, analysing clinical charts of HIV positive patient’s older than 18 years of age and on a TDF-containing regimen for more than 1 year. Data were obtained from the analysis of patient files and was transcribed into Microsoft® Excel® spreadsheet. Extracted data were coded, categorised and analysed using STATA®. Results: A total of 275 patient files were included in this study. Renal function started decreasing after 3 months of treatment (with 93.5% patients having a normal EGFR), and kept on decreasing as time progressed with only 39.6% normal renal function at year 4. Additional risk factors for renal insufficiency included age below 25, female gender, and additional medication. Conclusion: It is clear from this study that the use of TDF necessitates intensive monitoring and management of adverse effects arising from prolonged exposure to the drug. The findings from this study generated pertinent information on the safety profile of the drug TDF in a resource-limited setting of a public health institution. The appropriate management is of tremendous importance in the South African context where the majority of HIV positive individuals are on the TDF containing regimen; thus it is beneficial to ascertain the possible level of toxicities these patients may be experiencing.

Keywords: renal insufficiency, tenefovir, HIV, risk factors

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48110 Epidemiology of Primary Bronchopulmonary Cancer in Tunisia

Authors: Melliti Rihab, Zaeid Sonia, Khechine Wiem, Daldoul Amira

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Introduction: Lung cancer is the leading cause of cancer death. Its incidence is increasing, and its prognosis remains pejorative. We present the clinical, pathological, and therapeutic characteristics of bronchopulmonary cancer (BPC) in Tunisia. Methods: Retrospective study including patients followed in the oncology department of the University Hospital of Monastir between April 2014 and December 2021 suffering from lung cancer. Results: These are 117 patients, including 86.3% men and 13.7% women (sex ratio 6.3). The average age was 64 years ± 9 (37-83), with 95.7% being over 50 years old. Patients were smokers in 82% of cases. The clinical signs were dominated by chest pain (27.5%) and dyspnea in 21.1% of cases. In 6 patients, an episode of COVID-19 infection revealed the diagnosis. Half of the patients had a PS between 0 and 1. Small cell lung cancer was present in 18 patients (15.4%). The majority of non small cell lung cancer was of the adenocarcinoma type (68.7%). The diagnosis was late (stage IV) in 62.4% of cases. BPC was metastatic to bone (52%), contralateral lung (25.9%), and brain (27.3%). Patients were oligometastatic in 26% of cases. Surgery and radiotherapy were performed respectively in 14.5% and 23.1% of cases. Three-quarters of the patients had had nutrition (75.2%). The ROS1 mutation was present in 1 patient. PDL-1 expression was >40% in 2 patients. Survival was mean eight months ± 7.4. Conclusion: Lung cancer is diagnosed at a late stage in Tunisia. The lack of molecular study for non-small cell PBC and the lack of marketing authorization for tyrosine kinase inhibitors in Tunisia make the management incomplete.

Keywords: SCLC, NCSLC, ROS1, PDL1

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48109 Effects of Renin Angiotensin Pathway Inhibition on Efficacy of Anti-PD-1/PD-L1 Treatment in Metastatic Cancer

Authors: Philip Friedlander, John Rutledge, Jason Suh

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Inhibition of programmed death-1 (PD-1) or its ligand PD-L1 confers therapeutic efficacy in a wide range of solid tumor malignancies. Primary or acquired resistance can develop through activation of immunosuppressive immune cells such as tumor-associated macrophages. The renin angiotensin system (RAS) systemically regulates fluid and sodium hemodynamics, but components are expressed on and regulate the activity of immune cells, particularly of myeloid lineage. We hypothesized that inhibition of RAS would improve the efficacy of PD-1/PD-L-1 treatment. A retrospective analysis was performed through a chart review of patients with solid metastatic malignancies treated with a PD-1/PD-L1 inhibitor between 1/2013 and 6/2019 at Valley Hospital, a community hospital in New Jersey, USA. Efficacy was determined by medical oncologist documentation of clinical benefit in visit notes and by the duration of time on immunotherapy treatment. The primary endpoint was the determination of efficacy differences in patients treated with an inhibitor of RAS ( ace inhibitor, ACEi, or angiotensin blocker, ARB) compared to patients not treated with these inhibitors. To control for broader antihypertensive effects, efficacy as a function of treatment with beta blockers was assessed. 173 patients treated with PD-1/PD-L-1 inhibitors were identified of whom 52 were also treated with an ACEi or ARB. Chi-square testing revealed a statistically significant relationship between being on an ACEi or ARB and efficacy to PD-1/PD-L-1 therapy (p=0.001). No statistically significant relationship was seen between patients taking or not taking beta blocker antihypertensives (p= 0.33). Kaplan-Meier analysis showed statistically significant improvement in the duration of therapy favoring patients concomitantly treated with ACEi or ARB compared to patients not exposed to antihypertensives and to those treated with beta blockers. Logistic regression analysis revealed that age, gender, and cancer type did not have significant effects on the odds of experiencing clinical benefit (p=0.74, p=0.75, and p=0.81, respectively). We conclude that retrospective analysis of the treatment of patients with solid metastatic tumors with anti-PD-1/PD-L1 in a community setting demonstrates greater clinical benefit in the context of concomitant ACEi or ARB inhibition, irrespective of gender or age. This data supports the development of prospective assessment through randomized clinical trials.

Keywords: angiotensin, cancer, immunotherapy, PD-1, efficacy

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48108 Role of Direct Immunofluorescence in Diagnosing Vesiculobullous Lesions

Authors: Mitakshara Sharma, Sonal Sharma

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Vesiculobullous diseases are heterogeneous group of dermatological disorders with protean manifestations. The most important technique for the patients with vesiculobullous diseases is conventional histopathology and confirmatory tests like direct immunofluorescence (DIF) and indirect immunofluorescence (IIF). DIF has been used for decades to investigate pathophysiology and in the diagnosis. It detects molecules such as immunoglobulins and complement components. It is done on the perilesional skin. Diagnosis of DIF test depends on features like primary site of the immune deposits, class of immunoglobulin, number of immune deposits and deposition at other sites. The aim of the study is to correlate DIF with clinical and histopathological findings and to analyze the utility of DIF in the diagnosis of these disorders. It is a retrospective descriptive study conducted for 2 years from 2015 to 2017 in Department of Pathology, GTB Hospital on perilesional punch biopsies of vesiculobullous lesions. Biopsies were sent in Michael’s medium. The specimens were washed, frozen and incubated with fluorescein isothiocyanate (FITC) tagged antihuman antibodies IgA, IgG, IgM, C3 & F and were viewed under fluorescent microscope. Out of 401 skin biopsies submitted for DIF, 285 were vesiculobullous diseases, in which the most common was Pemphigus vulgaris (34%) followed by Bullous pemphigoid (21.5%), Dermatitis herpetiformis (16%), Pemphigus foliaceus (11.9%), Linear IgA disease (11.9%), Epidermolysisbullosa (2.39%) and Pemphigus herpetiformis (1.7%). We will be presenting the DIF findings in the all these vesiculobullous diseases. DIF in conjugation with histopathology gives the best diagnostic yield in these lesions. It also helps in the diagnosis whenever there is a clinical and histopathological overlap.

Keywords: antibodies, direct immunofluorescence, pemphigus, vesiculobullous

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48107 Radiographic Predictors of Mandibular Third Molar Extraction Difficulties under General Anaesthetic

Authors: Carolyn Whyte, Tina Halai, Sonita Koshal

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Aim: There are many methods available to assess the potential difficulty of third molar surgery. This study investigated various factors to assess whether they had a bearing on the difficulties encountered. Study design: A retrospective study was completed of 62 single mandibular third molar teeth removed under day case general anaesthesia between May 2016 and August 2016 by 3 consultant oral surgeons. Method: Data collection was by examining the OPG radiographs of each tooth and recording the necessary data. This was depth of impaction, angulation, bony impaction, point of application in relation to second molar, root morphology, Pell and Gregory classification and Winters Lines. This was completed by one assessor and verified by another. Information on medical history, anxiety, ethnicity and age were recorded. Case notes and surgical entries were examined for any difficulties encountered. Results: There were 5 cases which encountered surgical difficulties which included fracture of root apices (3) which were left in situ, prolonged bleeding (1) and post-operative numbness >6 months(1). Four of the 5 cases had Pell and Gregory classification as (B) where the occlusal plane of the impacted tooth is between the occlusal plane and the cervical line of the adjacent tooth. 80% of cases had the point of application as either coronal or apical one third (1/3) in relation to the second molar. However, there was variability in all other aspects of assessment in predicting difficulty of removal. Conclusions: Of the cases which encountered difficulties they all had at least one predictor of potential complexity but these varied case by case.

Keywords: impaction, mandibular third molar, radiographic assessment, surgical removal

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48106 Colorectal Resection in Endometriosis: A Study on Conservative Vascular Approach

Authors: A. Zecchin, E. Vallicella, I. Alberi, A. Dalle Carbonare, A. Festi, F. Galeone, S. Garzon, R. Raffaelli, P. Pomini, M. Franchi

Abstract:

Introduction: Severe endometriosis is a multiorgan disease, that involves bowel in 31% of cases. Disabling symptoms and deep infiltration can lead to bowel obstruction: surgical bowel treatment may be needed. In these cases, colorectal segment resection is usually performed by inferior mesenteric artery ligature, as radically as for oncological surgery. This study was made on surgery based on intestinal vascular axis’ preservation. It was assessed postoperative complications risks (mainly rate of dehiscence of intestinal anastomoses), and results were compared with the ones found in literature about classical colorectal resection. Materials and methods: This was a retrospective study based on 62 patients with deep infiltrating endometriosis of the bowel, which undergo segmental resection with intestinal vascular axis preservation, between 2013 and 2016. It was assessed complications related to the intervention both during hospitalization and 30-60 days after resection. Particular attention was paid to the presence of anastomotic dehiscence. 52 patients were finally telephonically interviewed in order to investigate the presence or absence of intestinal constipation. Results and Conclusion: Segmental intestinal resection performed in this study ensured a more conservative vascular approach, with lower rate of anastomotic dehiscence (1.6%) compared to classical literature data (10.0% to 11.4% ). No complications were observed regarding spontaneous recovery of intestinal motility and bladder emptying. Constipation in some patients, even after years of intervention, is not assessable in the absence of a preoperative constipation state assessment.

Keywords: anastomotic dehiscence, deep infiltrating endometriosis, colorectal resection, vascular axis preservation

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48105 Evaluating the Management of Febrile Infants (Less than 90 Days) Presenting to Tallaght Ed- Completed Audit Cycle

Authors: Amel Osman, Stewart McKenna

Abstract:

Aim: Fever may present as the sole sign of a serious underlying infection in young infants. Febrile Infants aged less than 90 days are at an elevated susceptibility to invasive bacterial infections, thus presenting a challenge in ensuring the appropriate management of these cases. This study aims to ensure strict adherence to NICE guidelines for the management of fever in infants between 0 and 90 days presenting to Tallaght Hospital ED. A comprehensive audit, followed by a re-audit, was conducted to enhance the quality of care delivered to these patients. In accordance with NICE guidelines, all febrile infants should undergo blood tests. Additionally, LP should be performed in all neonates under 28 days, infants displaying signs of illness, and those with WCC below 5 or above 15. Method: A retrospective case review was performed, encompassing all patients aged between 0 to 90 days who presented with fever at Tallaght ED. Data retrieval was conducted from electronic records on two separate occasions, six months apart. The evaluation encompassed the assessment of body temperature as well as both partial and full septic workups. Results: Over the study period, 150 infants presented to the ED with fever in the initial audit, and 120 in the re-audit. In the first study, 81 patients warranted a full septic workup as per NICE, but only 48 received it. Conversely, 40 patients met criteria for a partial septic workup, with 12 undergoing blood tests. In the second study, 73 patients qualified for a full septic workup, of which 52 were completed. Additionally, 27 patients were indicated for a partial workup, with 20 undergoing blood tests. Conclusion: Managing febrile infants under three months of age presenting to Tallaght ED remains a persistent challenge, underscoring the need for continuous educational initiatives to guarantee that these patients receive the requisite assessments and treatments.

Keywords: infants, fever, septic workup, tallaght

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48104 Functional Outcome of Femoral Neck System (FNS) In the Management of Neck of Femur Fractures

Authors: Ronak Mishra, Sachin Kale

Abstract:

Background: The clinical outcome of a new fixation device (femoral neck system, FNS) for femoral neck fractures is not described properly. The main purpose of this study was to evaluate the functional outcome of the patients of femoral neck fractures treated with FNS. Methods: A retrospective study was done among patients aged 60 years or less. On the basis of inclusion and exclusion criteria a final sample size of 30 was considered. Blood loss, type of fracture internal fixation, and length of clinical follow-up were all acquired from patient records. The volume of blood loss was calculated. The mean and standard deviation of continuous variables were reported (with range). Harris Hip score (HHS) And Post op xrays at intervals(6 weeks, 6 months ,12 months ) we used to clinically asses the patient. Results: Out of all 60% were females and 40% were males. The mean age of the patients was. 44.12(+-) years The comparison of functional outcomes of the patients treated with FNS using Harris Hip Score. It showed a highly significant comparison between the patients at post operatively , 6 weeks and 3 months and 12 months . There were no postoperative complications seen among the patients. Conclusion: FNS offers superior biomechanical qualities and greatly improved overall build stability. It allows for a significant reduction in operation time, potentially lowering risks and consequences associated with surgery.

Keywords: FNS, trauma, hip, neck femur fracture, minimally invasive surgery

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48103 Minimal Invasive Esophagectomy for Esophageal Cancer: An Institutional Review From a Dedicated Centre of Pakistan

Authors: Nighat Bakhtiar, Ali Raza Khan, Shahid Khan Khattak, Aamir Ali Syed

Abstract:

Introduction: Chemoradiation followed by resection has been the standard therapy for resectable (cT1-4aN0-3M0) esophageal carcinoma. The optimal surgical approach remains a matter of debate. Therefore, the purpose of this study was to share our experiences of minimal invasive esophagectomies concerning morbidity, mortality and oncological quality. This study aims to enlighten the world about the surgical outcomes after minimally invasive esophagectomy at Shaukat Khanum Hospital Lahore. Objective: The purpose of this study is to review an institutional experience of Surgical outcomes of Minimal Invasive esophagectomies for esophageal cancer. Methodology: This retrospective study was performed after ethical approval at Shaukat Khanum Memorial Cancer Hospital and Research Centre (SKMCH&RC) Pakistan. Patients who underwent Minimal Invasive esophagectomies for esophageal cancer from March 2018 to March 2023 were selected. Data was collected through the human information system (HIS) electronic database of SKMCH&RC. Data was described using mean and median with minimum and maximum values for quantitative variables. For categorical variables, a number of observations and percentages were reported. Results: A total of 621 patients were included in the study, with the mean age of the patient was 39 years, ranging between 18-58 years. Mean Body Mass Index of patients was 21.2.1±4.1. Neo-adjuvant chemoradiotherapy was given to all patients. The mean operative time was 210.36 ± 64.51 minutes, and the mean blood loss was 121 milliliters. There was one mortality in 90 days, while the mean postoperative hospital stay was 6.58 days with a 4.64 standard deviation. The anastomotic leak rate was 4.2%. Chyle leak was observed in 12 patients. Conclusion: The minimal invasive technique is a safe approach for esophageal cancers, with minimal complications and fast recovery.

Keywords: minimal invasive, esophagectomy, laparscopic, cancer

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48102 Surveillance of Hepatitis C Virus Genotype Circulating in North India

Authors: Shantanu Prakash, Suruchi Shukla, Amita Jain

Abstract:

Introduction: The hepatitis C virus (HCV) is a major public health problem and a leading cause of chronic liver disease. Injection drug use and individuals receiving blood and blood products are the primary modes of HCV transmission. Our study aims to establish the prevalent genotypes/ subtypes of HCV circulating in Uttar Pradesh, North India, as reported from a tertiary care hospital. Methods: It is a retrospective observational analysis of consecutive 404 HCV RNA positive cases referred to our hospital during September 2014 to April 2017. The study was approved by an institutional ethics committee. Written informed consent was taken from each participant. Clinical and demographic details of these patients were recorded using predesigned questionnaires. All the laboratory testing was carried on stored serum sample of enrolled cases. Genotyping of all 404 strains was done by Sanger’s sequencing of the core region. The phylogenetic analysis of 179 HCV strains with high -quality sequencing data was performed. Results: The distribution of prevalent genotypes/ subtypes as noted in the present study was; Genotype (GT)1a [n-101(25%)], GT1b [n-12(2.9%)], GT1c [1(0.25%)], GT3a [275(68.07%)], GT3b [9(2.2%)], GT3g [2(0.49%)], GT3i [3(0.74%)], and GT4a [1(0.24%)]. HCV genotypes GT2, GT5 and GT6 were not detected from our region. Sequence analysis showed high genotypic variability in HCV GT3. Phylogenetic analysis showed that HCV GT3 and GT1 circulating in our region were related to Indian strains reported earlier. Conclusions: HCV genotypes 3a and 1a are commonest circulating genotypes in Uttar Pradesh (UP), India.

Keywords: Hepatitis C virus, genetic variation, bioinformatics, genotype, HCV

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48101 Pattern of Adverse Drug Reactions with Platinum Compounds in Cancer Chemotherapy at a Tertiary Care Hospital in South India

Authors: Meena Kumari, Ajitha Sharma, Mohan Babu Amberkar, Hasitha Manohar, Joseph Thomas, K. L. Bairy

Abstract:

Aim: To evaluate the pattern of occurrence of adverse drug reactions (ADRs) with platinum compounds in cancer chemotherapy at a tertiary care hospital. Methods: It was a retrospective, descriptive case record study done on patients admitted to the medical oncology ward of Kasturba Hospital, Manipal from July to November 2012. Inclusion criteria comprised of patients of both sexes and all ages diagnosed with cancer and were on platinum compounds, who developed at least one adverse drug reaction during or after the treatment period. CDSCO proforma was used for reporting ADRs. Causality was assessed using Naranjo Algorithm. Results: A total of 65 patients was included in the study. Females comprised of 67.69% and rest males. Around 49.23% of the ADRs were seen in the age group of 41-60 years, followed by 20 % in 21-40 years, 18.46% in patients over 60 years and 12.31% in 1-20 years age group. The anticancer agents which caused adverse drug reactions in our study were carboplatin (41.54%), cisplatin (36.92%) and oxaliplatin (21.54%). Most common adverse drug reactions observed were oral candidiasis (21.53%), vomiting (16.92%), anaemia (12.3%), diarrhoea (12.3%) and febrile neutropenia (0.08%). The results of the causality assessment of most of the cases were probable. Conclusion: The adverse effect of chemotherapeutic agents is a matter of concern in the pharmacological management of cancer as it affects the quality of life of patients. This information would be useful in identifying and minimizing preventable adverse drug reactions while generally enhancing the knowledge of the prescribers to deal with these adverse drug reactions more efficiently.

Keywords: adverse drug reactions, platinum compounds, cancer, chemotherapy

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48100 Medical Radiation Exposure in a Cohort of Children Diagnosed with Solid Tumors: Single Institution Study 1985-2015

Authors: Robin L. Rohrer

Abstract:

Introduction: Pre-natal or early childhood exposure to the medical radiation used in diagnosis or treatment is an identified risk for childhood cancers but can be difficult to document. The author developed a family questionnaire/interview form to identify possible exposures. Aims: This retrospective study examines pre-natal and early childhood medical radiation exposure in a cohort of children diagnosed with a solid tumor including brain tumors from 1985-2015 at the Children’s Hospital of Pittsburgh (CHP). The hospital is a tri-state regional referral center which treats about 150-180 new cases of cancer in children per year. About 70% are diagnosed with a solid tumor. Methods: Each consented family so far (approximately 50% of the cohort) has been interviewed in person or by the phone call. Medical staff and psycho- social staff referred patient families for the interview with the author. Results: Among the families interviewed to date at least one medical radiation exposure has been identified (pre-conception, pre-natal or early childhood) in over 70% of diagnosed children. These exposures have included pre-conception sinus or chest CT or X-ray in either parent, sinus CT or X-ray in the mother or diagnostic radiation of chest or abdomen in children. Conclusions: Exposures to medical radiation for a child later diagnosed with cancer may occur at several critical junctures. These exposures may well contribute to a ‘perfect storm’ in the still elusive causes of childhood cancer. The author plans to expand the study from 1975 to present to hopefully further document these junctures.

Keywords: pediatric, solid tumors, medical radiation, cancer

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48099 Place of Radiotherapy in the Treatment of Intracranial Meningiomas: Experience of the Cancer Center Emir Abdelkader of Oran Algeria

Authors: Taleb L., Benarbia M., Boutira F. M., Allam H., Boukerche A.

Abstract:

Introduction and purpose of the study: Meningiomas are the most common non-glial intracranial tumors in adults, accounting for approximately 30% of all central nervous system tumors. The aim of our study is to determine the epidemiological, clinical, therapeutic, and evolutionary characteristics of a cohort of patients with intracranial meningioma treated with radiotherapy at the Emir Abdelkader Cancer Center in Oran. Material and methods: This is a retrospective study of 44 patients during the period from 2014 to 2020. The overall survival and relapse-free survival curves were calculated using the Kaplan-Meier method. Results and statistical analysis: The median age of the patients was 49 years [21-76 years] with a clear female predominance (sex ratio=2.4). The average diagnostic delay was seven months [2 to 24 months], the circumstances of the discovery of which were dominated by headaches in 54.5% of cases (n=24), visual disturbances in 40.9% (n=18), and motor disorders in 15.9% (n=7). The seat of the tumor was essentially at the level of the base of the skull in 52.3% of patients (n=23), including 29.5% (n=13) at the level of the cavernous sinus, 27.3% (n=12) at the parasagittal level and 20.5% (n=9) at the convexity. The diagnosis was confirmed surgically in 36 patients (81.8%) whose anatomopathological study returned in favor of grades I, II, and III in respectively 40.9%, 29.5%, and 11.4% of the cases. Radiotherapy was indicated postoperatively in 45.5% of patients (n=20), exclusive in 27.3% (n=12) and after tumor recurrence in 27.3% of cases (n=18). The irradiation doses delivered were as follows: 50 Gy (20.5%), 54 Gy (65.9%), and 60 Gy (13.6%). With a median follow-up of 69 months, the probabilities of relapse-free survival and overall survival at three years are 93.2% and 95.4%, respectively, whereas they are 71.2% and 80.7% at five years. Conclusion: Meningiomas are common primary brain tumors. Most often benign but can also progress aggressively. Their treatment is essentially surgical, but radiotherapy retains its place in specific situations, allowing good tumor control and overall survival.

Keywords: diagnosis, meningioma, surgery, radiotherapy, survival

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48098 Evaluation of the Analytic for Hemodynamic Instability as a Prediction Tool for Early Identification of Patient Deterioration

Authors: Bryce Benson, Sooin Lee, Ashwin Belle

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Unrecognized or delayed identification of patient deterioration is a key cause of in-hospitals adverse events. Clinicians rely on vital signs monitoring to recognize patient deterioration. However, due to ever increasing nursing workloads and the manual effort required, vital signs tend to be measured and recorded intermittently, and inconsistently causing large gaps during patient monitoring. Additionally, during deterioration, the body’s autonomic nervous system activates compensatory mechanisms causing the vital signs to be lagging indicators of underlying hemodynamic decline. This study analyzes the predictive efficacy of the Analytic for Hemodynamic Instability (AHI) system, an automated tool that was designed to help clinicians in early identification of deteriorating patients. The lead time analysis in this retrospective observational study assesses how far in advance AHI predicted deterioration prior to the start of an episode of hemodynamic instability (HI) becoming evident through vital signs? Results indicate that of the 362 episodes of HI in this study, 308 episodes (85%) were correctly predicted by the AHI system with a median lead time of 57 minutes and an average of 4 hours (240.5 minutes). Of the 54 episodes not predicted, AHI detected 45 of them while the episode of HI was ongoing. Of the 9 undetected, 5 were not detected by AHI due to either missing or noisy input ECG data during the episode of HI. In total, AHI was able to either predict or detect 98.9% of all episodes of HI in this study. These results suggest that AHI could provide an additional ‘pair of eyes’ on patients, continuously filling the monitoring gaps and consequently giving the patient care team the ability to be far more proactive in patient monitoring and adverse event management.

Keywords: clinical deterioration prediction, decision support system, early warning system, hemodynamic status, physiologic monitoring

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48097 A Comparative Study of Cognitive Functions in Relapsing-Remitting Multiple Sclerosis Patients, Secondary-Progressive Multiple Sclerosis Patients and Normal People

Authors: Alireza Pirkhaefi

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Background: Multiple sclerosis (MS) is one of the most common diseases of the central nervous system (brain and spinal cord). Given the importance of cognitive disorders in patients with multiple sclerosis, the present study was in order to compare cognitive functions (Working memory, Attention and Centralization, and Visual-spatial perception) in patients with relapsing- remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS). Method: Present study was performed as a retrospective study. This research was conducted with Ex-Post Facto method. The samples of research consisted of 60 patients with multiple sclerosis (30 patients relapsing-retrograde and 30 patients secondary progressive), who were selected from Tehran Community of MS Patients Supported as convenience sampling. 30 normal persons were also selected as a comparison group. Montreal Cognitive Assessment (MOCA) was used to assess cognitive functions. Data were analyzed using multivariate analysis of variance. Results: The results showed that there were significant differences among cognitive functioning in patients with RRMS, SPMS, and normal individuals. There were not significant differences in working memory between two groups of patients with RRMS and SPMS; while significant differences in these variables were seen between the two groups and normal individuals. Also, results showed significant differences in attention and centralization and visual-spatial perception among three groups. Conclusions: Results showed that there are differences between cognitive functions of RRMS and SPMS patients so that the functions of RRMS patients are better than SPMS patients. These results have a critical role in improvement of cognitive functions; reduce the factors causing disability due to cognitive impairment, and especially overall health of society.

Keywords: multiple sclerosis, cognitive function, secondary-progressive, normal subjects

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48096 Predicting COVID-19 Severity Using a Simple Parameters in Resource-Limited Settings

Authors: Sireethorn Nimitvilai, Ussanee Poolvivatchaikarn, Nuchanart Tomeun

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Objective: To determine the simple laboratory parameters to predict disease severity among COVID-19 patients in resource-limited settings. Material and methods: A retrospective cohort study was conducted at Nakhonpathom Hospital, a 722-bed tertiary care hospital, with an average of 50,000 admissions per year, during April 15 and May 15, 2021. Eligible patients were adults aged ≥ 15 years who were hospitalized with COVID-19. Baseline characteristics, comorbid conditions ad laboratory findings at admission were collected. Predictive factors for severe COVID-19 infection were analyzed. Result: There were 207 patients (79 male and 128 female) and the mean age was 46.7 (16.8) years. Of these, 39 cases (18.8%) were severe and 168 (81.2%) cases were non-severe. Factors associated with severe COVID-19 were neutrophil to lymphocyte ratio ≥ 4 (OR 8.1, 95%CI 2.3-20.3, P < 0.001) and C-reactive protein to albumin ratio ≥ 10 (OR 3.49, 95%CI 1.3-9.1, p 0.01). Conclusions: Complete blood counts, C-reactive protein and albumin are simple, inexpensive, widely available tests and can be used to predict severe COVID-19 in resource-limited settings.

Keywords: COVID-19, predictor of severity, resource-limiting settings, simple laboratory parameters

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48095 Evaluation of Trabectedin Safety and Effectiveness at a Tertiary Cancer Center at Qatar: A Retrospective Analysis

Authors: Nabil Omar, Farah Jibril, Oraib Amjad

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Purpose: Trabecatine is a is a potent marine-derived antineoplastic drug which binds to the minor groove of the DNA, bending DNA towards the major groove resulting in a changed conformation that interferes with several DNA transcription factors, repair pathways and cell proliferation. Trabectedin was approved by the European Medicines Agency (EMA; London, UK) for the treatment of adult patients with advanced stage soft tissue sarcomas in whom treatment with anthracyclines and ifosfamide has failed, or for those who are not candidates for these therapies. The recommended dosing regimen is 1.5 mg/m2 IV over 24 hours every 3 weeks. The purpose of this study was to comprehensively review available data on the safety and efficacy of trabectedin used as indicated for patients at a Tertiary Cancer Center at Qatar. Methods: A medication administration report generated in the electronic health record identified all patients who received trabectedin between November 1, 2015 and November 1, 2017. This retrospective chart review evaluated the indication of trabectedin use, compliance to administration protocol and the recommended monitoring parameters, number of patients improved on the drug and continued treatment, number of patients discontinued treatment due to side-effects and the reported side effects. Progress and discharged notes were utilized to report experienced side effects during trabectedin therapy. A total of 3 patients were reviewed. Results: Total of 2 out of 3 patients who received trabectedin were receiving it for non-FDA and non-EMA, approved indications; metastatic rhabdomyosarcoma and ovarian cancer stage IV with poor prognosis. And only one patient received it as indicated for leiomyosarcoma of left ureter with metastases to liver, lungs and bone. None of the patients has continued the therapy due to development of serious side effects. One patient had stopped the medication after one cycle due to disease progression and transient hepatic toxicity, the other one had disease progression and developed 12 % reduction in LVEF after 12 cycles of trabectedin, and the third patient deceased, had disease progression on trabectedin after the 10th cycle that was received through peripheral line which resulted in developing extravasation and left arm cellulitis requiring debridement. Regarding monitoring parameters, at baseline the three patients had ECHO, and Creatine Phosphokinase (CPK) but it was not monitored during treatment as recommended. Conclusion: Utilizing this medication as indicated with performing the appropriate monitoring parameters as recommended can benefit patients who are receiving it. It is important to reinforce the intravenous administration via central intravenous line, the re-assessment of left ventricular ejection fraction (LVEF) by echocardiogram or multigated acquisition (MUGA) scan at 2- to 3-month intervals thereafter until therapy is discontinued, and CPK and LFTs levels prior to each administration of trabectedin.

Keywords: trabectedin, drug-use evaluation, safety, effectiveness, adverse drug reaction, monitoring

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48094 Toxicities associated with EBRT and Brachytherapy for Intermediate and High Risk Prostate Cancer, Correlated with Intra-operative Dosing

Authors: Rebecca Dunne, Cormac Small, Geraldine O'Boyle, Nazir Ibrahim, Anisha

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Prostate cancer is the most common cancer among men, excluding non-melanoma skin cancers. It is estimated that approximately 12% of men will develop prostate cancer during their lifetime. Patients with intermediate, high risk, and very-high risk prostate cancer often undergo a combination of radiation treatments. These treatments include external beam radiotherapy with a low-dose rate or high-dose rate brachytherapy boost, often with concomitant androgen deprivation therapy. The literature on follow-up of patients that receive brachytherapy is scarce, particularly follow-up of patients that undergo high-dose rate brachytherapy. This retrospective study aims to investigate the biochemical failure and toxicities associated with triple therapy and external beam radiotherapy given in combination with brachytherapy. Reported toxicities and prostate specific antigen (PSA) were retrospectively evaluated in eighty patients that previously underwent external beam radiotherapy with a low-dose rate or high dose-rate brachytherapy boost. The severity of toxicities were correlated with intra-operative dosing during brachytherapy on ultrasound and CT scan. The results of this study will provide further information for clinicians and patients when considering treatment options.

Keywords: toxicities, combination, brachytherapy, intra-operative dosing, biochemical failure

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