Search results for: clinical symptoms

Authors: Ma. Cecilia D. Licuan

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The pandemic situation continues to affect the lives of many people, including children with disabilities and their families, globally, especially in developing countries like the Philippines. The operations of health programs, industries, and economic sectors, as well as academic training institutions, are still challenged in terms of operations and delivery of services. The academic community of the Physical Therapy program is not spared by this circumstance. The restriction posted by the quarantine policies nearly terminated the onsite delivery of training programs for the senior internship level, which challenged the academic institutions to implement flexible learning programs to ensure the continuity of the instructional and learning processes with full consideration of safety and compliance to health protocols. This study aimed to develop a benchmark model that can be used by tertiary-level health institutions in the implementation of the Pediatric Senior Clinical Internship Training Program using Telerehabilitation. It is a descriptive-qualitative paper that utilized documentary analysis and focused on explaining the design, development, and implementation processes used by De La Salle Medical and Health Sciences Institute – College of Rehabilitation Sciences (DLSMHSI-CRS) Physical Therapy Department in its Pediatric Cluster Senior Clinical Internship Training Program covering the pandemic years spanning from the academic year 2020- 2021 to present anchored on needs analysis based on documentary reviews. Results of the study yielded the determination of the Pediatric Telerehabilitation Model; declaration of developed training program outcomes and thrusts and content; explanation of the process integral to the training program’s pedagogy in implementation; and the evaluation procedures conducted for the program. Since the study did not involve human participants, ethical considerations on the use of documents for review were done upon the endorsement of the management of the DLSMHSI-CRS to conduct the study. This paper presents the big picture of how a tertiary-level health sciences institution in the Philippines embraced the senior clinical internship challenges through the operations of its telerehabilitation program. It specifically presents the design, development and implementation processes used by De La Salle Medical and Health Sciences Institute – College of Rehabilitation Sciences Physical Therapy Department in its Pediatric Cluster Senior Clinical Internship Training Program, which can serve as a benchmark model for other institutions as they continue to serve their stakeholders amidst the pandemic.

Keywords: pediatric physical therapy, telerehabilitation, clinical internship, pandemic

Procedia PDF Downloads 117

Authors: Shoukat Ali, Abdul Qadir Jandga, Amjad Hussain

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Objective: The main purpose of this study is to compare the Percent Depth dose (PDD) and In-plane and cross-plane profiles of Varian Golden beam data to the measured data of 6 and 18 MV photons for the commissioning of Eclipse treatment planning system. Introduction: Commissioning of treatment planning system requires an extensive acquisition of beam data for the clinical use of linear accelerators. Accurate dose delivery require to enter the PDDs, Profiles and dose rate tables for open and wedges fields into treatment planning system, enabling to calculate the MUs and dose distribution. Varian offers a generic set of beam data as a reference data, however not recommend for clinical use. In this study, we compared the generic beam data with the measured beam data to evaluate the reliability of generic beam data to be used for the clinical purpose. Methods and Material: PDDs and Profiles of Open and Wedge fields for different field sizes and at different depths measured as per Varian’s algorithm commissioning guideline. The measurement performed with PTW 3D-scanning water phantom with semi-flex ion chamber and MEPHYSTO software. The online available Varian Golden Beam Data compared with the measured data to evaluate the accuracy of the golden beam data to be used for the commissioning of Eclipse treatment planning system. Results: The deviation between measured vs. golden beam data was in the range of 2% max. In PDDs, the deviation increases more in the deeper depths than the shallower depths. Similarly, profiles have the same trend of increasing deviation at large field sizes and increasing depths. Conclusion: Study shows that the percentage deviation between measured and golden beam data is within the acceptable tolerance and therefore can be used for the commissioning process; however, verification of small subset of acquired data with the golden beam data should be mandatory before clinical use.

Keywords: percent depth dose, flatness, symmetry, golden beam data

Procedia PDF Downloads 483

Authors: P. Donnelly, G. Mitchell

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Traumatic Brain Injury (TBI) is a major contributor to the global burden of disease; despite its ubiquity, there is significant variation in diagnosis, prognosis, and treatment between clinicians. This study aims to examine the spectrum of approaches that currently exist at a Level 1 Trauma Centre in Australasia by surveying Emergency Physicians and Neurosurgeons on those aspects of mTBI. A pilot survey of 17 clinicians (Neurosurgeons, Emergency Physicians, and others who manage patients with mTBI) at a Level 1 Trauma Centre in Brisbane, Australia, was conducted. The objective of this study was to examine the importance these clinicians place on various elements in their approach to the diagnosis, prognostication, and treatment of mTBI. The data were summarised, and the descriptive statistics reported. Loss of consciousness and post-traumatic amnesia were rated as the most important signs or symptoms in diagnosing mTBI (median importance of 8). MRI was the most important imaging modality in diagnosing mTBI (median importance of 7). ‘Number of the Previous TBIs’ and Intracranial Injury on Imaging’ were rated as the most important elements for prognostication (median importance of 9). Education and reassurance were rated as the most important modality for treating mTBI (median importance of 7). There was a statistically insignificant variation between the specialties as to the importance they place on each of these components. In this Australian tertiary trauma center, there appears to be variation in how clinicians approach mTBI. This study is underpowered to state whether this is between clinicians within a specialty or a trend between specialties. This variation is worthwhile in investigating as a step toward a unified approach to diagnosing, prognosticating, and treating this common pathology.

Keywords: mild traumatic brain injury, adult, clinician, survey

Procedia PDF Downloads 128

Authors: Ayman M. Mansour, Bilal Hawashin, Hesham Alsalem

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Faster delivery of laboratory test results is one of the most noticeable signs of good laboratory service and is often used as a key performance indicator of laboratory performance. Despite the availability of technology, the delivery time of clinical laboratory test results continues to be a cause of customer dissatisfaction which makes patients feel frustrated and they became careless to get their laboratory test results. The Medical Clinical Laboratory test results are highly sensitive and could harm patients especially with the severe case if they deliver in wrong time. Such results affect the treatment done by physicians if arrived at correct time efforts should, therefore, be made to ensure faster delivery of lab test results by utilizing new trusted, Robust and fast system. In this paper, we proposed a distributed Multi-Agent System to enhance and faster the process of laboratory test results delivery using SMS. The developed system relies on SMS messages because of the wide availability of GSM network comparing to the other network. The software provides the capability of knowledge sharing between different units and different laboratory medical centers. The system was built using java programming. To implement the proposed system we had many possible techniques. One of these is to use the peer-to-peer (P2P) model, where all the peers are treated equally and the service is distributed among all the peers of the network. However, for the pure P2P model, it is difficult to maintain the coherence of the network, discover new peers and ensure security. Also, security is a quite important issue since each node is allowed to join the network without any control mechanism. We thus take the hybrid P2P model, a model between the Client/Server model and the pure P2P model using GSM technology through SMS messages. This model satisfies our need. A GUI has been developed to provide the laboratory staff with the simple and easy way to interact with the system. This system provides quick response rate and the decision is faster than the manual methods. This will save patients life.

Keywords: multi-agent system, delivery process, GSM technology, clinical laboratory results

Procedia PDF Downloads 244

Authors: Doran C. Kalmin

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The descending genicular artery (DGA) perforator free flap provides an alternative to free flap reconstruction based on a review of the literature detailing both anatomical and clinical studies. The descending genicular artery (DGA) supplies skin, muscle, tendon, and bone located around the medial aspect of the knee that has been used in several pioneering reports in reconstructing defects located in various areas throughout the body. After the success of the medial femoral condyle flap in early studies, a small number of studies have been published detailing the use of the DGA in free flap reconstruction. Despite early success in the use of the DGA flap, acceptance within the Plastic and Reconstructive Surgical community has been limited due primarily to anatomical variations of the pedicle. This literature review is aimed at detailing the progression of the DGA perforator free flap and its variations as an alternative and reliable free flap for reconstruction of composite defects with an exploration into both anatomical and clinical studies. A literature review was undertaken, and the progression of the DGA flap is explored from the early review by Acland et al. pioneering the saphenous free flap to exploring modern changes and studies of the anatomy of the DGA. An extensive review of the literature was undertaken that details the anatomy and its variations, approaches to harvesting the flap, the advantages, and disadvantages of the DGA perforator free flap as well as flap outcomes. There are 15 published clinical series of DGA perforator free flaps that incorporate cutaneous, osteoperiosteal, cartilage, osteocutaneous, osteoperiosteal and muscle, osteoperiosteal and subcutaneous and tendocutatenous. The commonest indication for using a DGA free flap was for non-union of bone, particularly that of the scaphoid whereby the medial femoral condyle could be used. In the case series, a success rate of over 90% was established, showing that these early studies have had good success with a wide range of tissue transfers. The greatest limitation is the anatomical variation of the DGA and therefore, the challenges associated with raising the flap. Despite the variation in anatomy and around 10-15% absence of the DGA, the saphenous artery can be used as well as the superior medial genicular artery if the vascular bone is required as part of the flap. Despite only a handful of anatomical and clinical studies describing the DGA perforator free flap, it ultimately provides a reliable flap that can include a variety of composite structure used for reconstruction in almost any area throughout the body. Although it has limitations, it provides a reliable option for free flap reconstruction that can routinely be performed as a single-stage procedure.

Keywords: anatomical study, clinical study, descending genicular artery, literature review, perforator free flap reconstruction

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Authors: Thomas Heffernan, Nick Neave, Colin Hamilton, Gill Case

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Hoarding is the acquisition of and failure to discard possessions, leading to excessive clutter and significant psychological/emotional distress. From a cognitive-behavioural approach, excessive hoarding arises from information-processing deficits, as well as from problems with emotional attachment to possessions and beliefs about the nature of possessions. In terms of information processing, hoarders have shown deficits in executive functions, including working memory, planning, inhibitory control, and cognitive flexibility. However, this previous research is often confounded by co-morbid factors such as anxiety, depression, or obsessive-compulsive disorder. The current study adopted a cognitive-behavioural approach, specifically assessing executive deficits and working memory in a non-clinical sample of hoarders, compared with non-hoarders. In this study, a non-clinical sample of 40 hoarders and 73 non-hoarders (defined by The Savings Inventory-Revised) completed the Adult Executive Functioning Inventory, which measures working memory and inhibition, Dysexecutive Questionnaire-Revised, which measures general executive function and the Hospital Anxiety and Depression Scale, which measures mood. The participant sample was made up of unpaid young adult volunteers who were undergraduate students and who completed the questionnaires on a university campus. The results revealed that, after observing no differences between hoarders and non-hoarders on age, sex, and mood, hoarders reported significantly more deficits in inhibitory control and general executive function when compared with non-hoarders. There was no between-group difference on general working memory. This suggests that non-clinical hoarders have a specific difficulty with inhibition-control, which enables you to resist repeated, unwanted urges. This might explain the hoarder’s inability to resist urges to buy and keep items that are no longer of any practical use. These deficits may be underpinned by general executive function deficiencies.

Keywords: hoarding, memory, executive, deficits

Procedia PDF Downloads 188

Authors: Ryuji Yamazaki, Masahiro Kochi, Weiran Zhu, Hiroko Kase

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In care for older adults, behavioral and psychological symptoms of dementia (BPSD) like agitation and aggression are distressing for patients and their caretakers, often resulting in premature institutionalization with increased costs of care. To improve mood and mitigate symptoms, as a non-pharmaceutical approach, emotion-oriented therapy like reminiscence work is adopted in face-to-face communication. Telecommunication support is expected to be provided by robotic media as a bridge for digital divide for those with dementia and facilitate social interaction both verbally and nonverbally. The purpose of this case study is to explore the conditions in which robotic media can effectively attract attention from older adults with dementia and promote their well-being. As a pilot study, we introduced the pillow-phone Hugvie^®, a huggable humanly shaped communication medium to five residents with dementia at a care facility, to investigate how the following conditions work for the elderly when they use the medium; 1) no sound, 2) radio, non-interactive, 3) daily conversation, and 4) reminiscence work. As a result, under condition 4, reminiscence work, the five participants kept concentration in interacting with the medium for a longer duration than other conditions. In condition 4, they also showed larger amount of utterances than under other conditions. These results indicate that providing topics related to personal histories through robotic media could affect communication positively and should, therefore, be further investigated. In addition, the issue of ethical implications by using persuasive technology that affects emotions and behaviors of older adults is also discussed.

Keywords: BPSD, reminiscence, tactile telecommunication, utterances

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Authors: Caroline F. Moeser

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The skin-gut axis defines the relationship between the intestinal microbiota and the development of pathological skin diseases. Low diversity within the gut can predispose to the development of allergic skin conditions, and a greater diversity of the gastrointestinal microflora has been associated with a reduction of skin flares in people with atopic dermatitis. Manipulation of the gut microflora has been used as a treatment option for several conditions in people, but there is limited data available on the use of faecal transplantation as a preventative measure in either people or dogs. Six, 4-month-old pups from a litter of ten were presented for diarrhea and/or signs of skin disease (chronic scratching, otitis externa). Of these pups, two were given probiotics with a resultant resolution of diarrhea. The other four pups were given faecal transplantation, either as a sole treatment or in combination with other treatments. Follow-up on the litter of ten pups was performed at 18 months of age. At this stage, the four pups that had received faecal transplantation had resolved all clinical signs and had no recurrence of either skin or gastrointestinal symptoms. Of the remaining six pups from the litter, all had developed at least one episode of Malassezia otitis externa within the period of 5 months to 18 months of age. Two pups had developed two Malassezia otitis infections, and one had developed three Malassezia otitis infections during this period. Favrot’s criteria for the diagnosis of canine atopic dermatitis include chronic or recurrent Malassezia infections by the age of three years. Early results from this litter predict a reduction in the development of canine atopic disease in dogs given faecal microbial transplantation. Follow-up studies at three years of age and within a larger population of dogs can enhance understanding of the impact of early faecal transplantation in the prevention of canine atopic dermatitis.

Keywords: canine atopic dermatitis, faecal microbial transplant, skin-gut axis, otitis

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Authors: Waqas Mehdi, Muhammad Umar Hassan, Khadeeja Mustafa

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Objective: Post-concussion syndrome (PCS) is a medical term used to point out the complicated combination of physical, emotional, cognitive and behavioral signs and symptoms associated with Mild Traumatic Brain Injury(mTBI). This study was conducted to assess the improvement or debilitating effect of behavioral therapy in addition to the conventional treatment and to document these results for increasing the efficiency of treatment provided to such cases. Method: This was primarily an interventional prospective cohort study which was conducted in the Department of Neurosurgery, Mayo Hospital Lahore. The sample size was 200 patients who were randomly distributed into two groups. The interventional group with Cognitive behavioral therapy was added in addition to the conventional treatment regimen and the Control group receiving only conventional treatment. Results were noted initially as well as after two weeks of the follow-up period. Data were subsequently analyzed by Statistical Package for Social Sciences (SPSS) software and associations worked out. Result and conclusion: Among the patients that were given therapy sessions along with conventional medicine, there was a significant improvement in the symptoms and their overall quality of life. It is also important to notice that the time period taken for these effects to wane is cut down by psychiatric solutions too. So we can conclude that CBT sessions not only speed up recovery in patients with post-concussion syndrome they also aid in the efficiency improvement in functional capability and quality of life.

Keywords: neurosurgery, CBT, PCS, mTBI

Procedia PDF Downloads 162

Authors: Eman A. Embaby, Amira A. A. Abdallah

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Background: Occupational standing is associated with low back pain (LBP) development. Yet, trunk and gluteus-medius muscles’ fatigability has not been extensively studied during occupational standing. This study examined and correlated the rectus abdominus (RA), erector-spinae (ES), external oblique (EO), and gluteus-medius (GM) muscles’ fatigability on both sides while standing in a confined area for 30 min Methods: Median frequency EMG data were collected from 15 female clinical instructors with chronic LBP (group A) and 15 asymptomatic controls (group B) (mean age 29.53±2.4 vs. 29.07±2.4 years, weight 63.6±7 vs. 60±7.8 kg, and height 162.73±4 vs. 162.8±6 cm respectively) using a spectrum analysis program. Data were collected in the first and last 5min of the standing task. Results: Using Mixed three-way ANOVA, group A showed significantly (p<0.05) lower frequencies for the right and left ES, and right GM in the last 5 min and significantly higher frequencies for the left RA in the first and last 5min than group B. In addition, the left ES and right EO, ES and GM in group B showed significantly higher frequencies and the left ES in group A showed significantly lower frequencies in the last 5min compared with the first. Moreover, the right RA showed significantly higher frequencies than the left in the last 5min in group B. Finally, there were significant (p<0.05) correlations among the median frequencies of the tested four muscles on the same side and between both sides in both groups. Discussion/Conclusions: Clinical instructors with LBP are more liable to have higher trunk and gluteus-medius muscle fatigue than asymptomatic individuals. Thus, endurance training for these muscles should be included in the rehabilitation of such patients.

Keywords: EMG, fatigability, gluteus-medius, LBP, standing, trunk

Procedia PDF Downloads 237

Authors: R. McGrath, A. Trace, S. Curtin, C. McCreary

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Introduction: Although, in relation to Burning Mouth Syndrome (BMS), much energy has been expended on its definition and etiology, it still remains a contentious issue. There is agreement on the symptoms, but on little else; and approaches to treatment vary widely. However, it has been established that the condition has a detrimental effect on the sufferer’s quality of life. Much research focus has been put on the physical impact of the syndrome. Recently, some literature has turned the focus to social, functional, and psychological factors. However, there is very little qualitative research on how burning mouth syndrome affects the lives of sufferer’s and the present study seeks to remedy this. Method: The study recruited five male participants who took part in semi-structured interviews lasting between 30 and 50 minutes. Data was analysed using Interpretative Phenomenological Analysis. Results: The study identified four super-ordinate themes: Lack of Control due to Uncertainty about Condition; Disruption to Internal Sense of Self; Negative Future Expectation due to Chronic Symptoms; and Sense of BMS as an Intrusive Force. Aspects of these themes reflect areas of reduction in quality of life. Conclusion: BMS damages an individual’s quality of life in ways that have not been reflected in self-report surveys of health-related quality of life. The condition has serious implications for the individual's sense of self, identity, and future. The study recommends that further qualitative research be carried out in this area. Also, the use of therapeutic interventions with sufferers from BMS is recommended, which would help not only sufferers but best practice in relation to their treatment.

Keywords: burning mouth syndrome, interpretative phenomenological analysis, qualitative research, quality of life

Procedia PDF Downloads 436

Authors: Jyoti Srivastava, Sandhya S. Kaushik, Mallika Tewari, Hari S. Shukla

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Little information is available about the development of psychological well being over time among women who have been undergoing treatment for breast cancer. The aim of this study was to identify the trajectories of depression anxiety and stress among women with early-stage breast cancer. Of the 48 Indian women with newly diagnosed early-stage breast cancer recruited from surgical oncology unit, 39 completed an interview and were assessed for depression anxiety and stress (Depression Anxiety Stress Scale-DASS 21) before their first course of chemotherapy (baseline) and follow up interviews at 3, 6 and 9 months thereafter. Growth mixture modeling was used to identify distinct trajectories of Depression Anxiety and Stress symptoms. Logistic Regression analysis was used to evaluate the characteristics of women in distinct groups. Most women showed mild to moderate level of depression and anxiety (68%) while normal to mild level of stress (71%). But one in 11 women was chronically anxious (9%) and depressed (9%). Young age, having a partner, shorter education and receiving chemotherapy but not radiotherapy might characterize women whose psychological symptoms remain strong nine months after diagnosis. By looking beyond the mean, it was found that several socio-demographic and treatment factors characterized the women whose depression, anxiety and stress level remained severe even nine months after diagnosis. The results suggest that support provided to cancer patients should have a special focus on a relatively small group of patient most in need.

Keywords: psychological well being, growth mixture modeling, logistic regression analysis, socio-demographic factors

Procedia PDF Downloads 143

Authors: Rosemary Saunders, Courtney Glass, Karla Seaman, Karen Gullick, Julie Andrew, Anne Wilkinson, Ashwini Davray

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Current literature demonstrates that most Australians receive end-of-life care in a hospital setting, despite most hoping to die within their own home. The necessity for high quality end-of-life care has been emphasised by the Australian Commission on Safety and Quality in Health Care and the National Safety and Quality in Health Services Standards depict the requirement for comprehensive care at the end of life (Action 5.20), reinforcing the obligation for continual organisational assessment to determine if these standards are suitably achieved. Limited research exploring clinical staff perspectives of end-of-life care delivery has been conducted within an Australian private health context. This study aimed to investigate clinical staff member perceptions of end-of-life care delivery at a private hospital in Western Australia. The study comprised of a multi-faceted mixed-methods methodology, part of a larger study. Data was obtained from clinical staff utilising surveys and focus groups. A total of 133 questionnaires were completed by clinical staff, including registered nurses (61.4%), enrolled nurses (22.7%), allied health professionals (9.9%), non-palliative care consultants (3.8%) and junior doctors (2.2%). A total of 14.7% of respondents were palliative care ward staff members. Additionally, seven staff focus groups were conducted with physicians (n=3), nurses (n=26) and allied health professionals including social workers (n=1), dietitians (n=2), physiotherapists (n=5) and speech pathologists (n=3). Key findings from the surveys highlighted that the majority of staff agreed it was part of their role to talk to doctors about the care of patients who they thought may be dying, and recognised the importance of communication, appropriate training and support for clinical staff to provide quality end-of-life care. Thematic analysis of the qualitative data generated three key themes: creating the setting which highlighted the importance of adequate resourcing and conducive physical environments for end-of-life care and to support staff and families; planning and care delivery which emphasised the necessity for collaboration between staff, families and patients to develop care plans and treatment directives; and collaborating in end-of-life care, with effective communication and teamwork leading to achievable care delivery expectations. These findings contribute to health professionals better understanding of end-of-life care provision and the importance of collaborating with patients and families in care delivery. It is crucial that health care providers implement strategies to overcome gaps in care, so quality end-of-life care is provided. Findings from this study have been translated into practice, with the development and implementation of resources, training opportunities, support networks and guidelines for the delivery of quality end-of-life care.

Keywords: clinical staff, end-of-life care, mixed-methods, private hospital.

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Authors: Helen Huang, Francisco Javier Quesada Ocet, Blanca Quesada Oce, Javier Jimenez Bello, Victor Palanca Gil, Alba Cervero Rubio, Ana Paya Chaume, Alejandro Herreros-Pomares, Fernando Vidal-Vanaclocha, Rafael Paya Serrano, Aurelio Quesada Dorador, Monica Soliman

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Background: Cancer favors both the pro-inflammatory state and autonomic dysfunction, two important mechanisms in the genesis of AF. Atrial remodeling might be caused as a result of paraneoplastic conditions or the result of direct expression of neoplasia. Here, we hypothesize that cancer, through inflammatory mediators, may favor the appearance of AF and patients with the first episode of AF could have a higher risk of developing cancer. Method: Data was collected from patients who attended the emergency department of our hospital for the first episode of AF, diagnosed electrocardiographically, between 2010-2015 (n = 712). The minimum follow-up was 2 years, recording the appearance of cancer, total mortality, recurrences of AF and other events. Patients who developed cancer and those who did not during the 2 years after the onset of AF were compared, as well as with the incidence of cancer in Spain in 2012. Results: After 2 years, 35 patients (4.91%) were diagnosed with cancer, with an annual incidence of 2.45%. Hematological neoplasms were the most frequent (34.28%). The cancer group was older (76.68 +/-12.75 years vs 74.16 +/-12.71; p <0.05) and had fewer typical symptoms (palpitations) (33.38% vs 14.28% , p <0.05). The incidence of cancer in Spain during 2012 was 0.46%, much lower than our sample. When comparing the incidence by age, these differences were maintained both in those over 65 years of age and in those under 65 years of age (2.17% vs. 0.28%; 0.28% vs. 0.18% respectively). Discussion: Therefore, a high incidence of cancer in patients with the first episode of AF was observed (the annual incidence of 2.45% after the onset of AF is 6.1 times that of the general population). After the evaluation of patients with AF in their first detected episode, surveillance of the appearance of cancer should be considered in clinical practice.

Keywords: cancer, cardiovascular outcomes, atrial fibrillation, inflammation

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Authors: Christine H. Cubelo

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This study consists of 2-parts: a systematic review of current publications on the therapeutic use of autonomous sensory meridian response (ASMR) and a within-subjects auditory training trial using ASMR videos. The main intent is to explore ASMR as potentially therapeutically beneficial for those with atypical sensory processing. Many hearing-related disorders and mood or anxiety symptoms overlap with symptoms of sensory processing issues. For this reason, inclusion and exclusion criteria of the systematic review were generated in an effort to produce optimal search outcomes and avoid overly confined criteria that would limit yielded results. Criteria for inclusion in the review for Part 1 are (1) adult participants diagnosed with hearing loss or atypical sensory processing, (2) inclusion of measures related to ASMR as a treatment method, and (3) published between 2000 and 2022. A total of 1,088 publications were found in the preliminary search, and a total of 13 articles met the inclusion criteria. A total of 14 participants completed the trial and post-trial questionnaire. Of all responses, 64.29% agreed that the duration of auditory training sessions was reasonable. In addition, 71.43% agreed that the training improved their perception of music. Lastly, 64.29% agreed that the training improved their perception of a primary talker when there are other talkers or background noises present.

Keywords: autonomous sensory meridian response, auditory training, atypical sensory processing, hearing loss, hearing aids

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Authors: Anita, Sari Septiani Tangke, Rusdina Bte Ladju, Nasrum Massi

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New diagnostic tools are urgently needed to interrupt the transmission of tuberculosis and multidrug-resistant tuberculosis. The microscopic-observation drug-susceptibility (MODS) assay is a rapid, accurate and simple liquid culture method to detect multidrug-resistant tuberculosis (MDR-TB). MODS were evaluated to determine a lower and same concentration of isoniazid and rifampin for detection of MDR-TB. Direct drug-susceptibility testing was performed with the use of the MODS assay. Drug-sensitive control strains were tested daily. The drug concentrations that used for both isoniazid and rifampin were at the same concentration: 0.16, 0.08 and 0.04μg per milliliter. We tested 56 M. tuberculosis clinical isolates and the control strains M. tuberculosis H37RV. All concentration showed same result. Of 53 M. tuberculosis clinical isolates, 14 were MDR-TB, 38 were susceptible with isoniazid and rifampin, 1 was resistant with isoniazid only. Drug-susceptibility testing was performed with the use of the proportion method using Mycobacteria Growth Indicator Tube (MGIT) system as reference. The result of MODS assay using lower concentration was significance (P<0.001) compare with the reference methods. A lower and same concentration of isoniazid and rifampin can be used to detect MDR-TB. Operational cost and application can be more efficient and easier in resource-limited environments. However, additional studies evaluating the MODS using lower and same concentration of isoniazid and rifampin must be conducted with a larger number of clinical isolates.

Keywords: isoniazid, MODS assay, MDR-TB, rifampin

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Authors: Amel Fayed, Shaden AlSubaih, Nouf Al-Qahtani, Asmaa Gosty, Asma Aljuhaimi

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Introduction: Sleep difficulties are vastly predominant among adults and affect different aspects of their life. Many literatures found out that females are more liable to suffer from sleeping problems. College students are typical example of people dealing with daily pressure and stress to fulfill the daily tasks and responsibilities. In addition to their ultimate goal of achieving excellent academic records which require their full concentration and effort. Consequently, many of them start complaining of sleep deprivations which can undesirably affect their academic achievements. This study was aiming to investigate how prevalent is sleeping disorders among different colleges in the university and its relation their academic achievements. Methods: A cross-sectional study of female university students at Princess Norah Bint Abdulrahman University using self-administered questionnaire was conducted. Insomnia Severity Index (ISI) was used to assess different grades of insomnia. Students were requested to answer the questions evaluating their sleeping habits over the last two weeks. Participants reported their latest Grade Point Average (GPA). According to ISI, insomnia severity is reported as ‘No clinically significant’, ‘Subthreshold ‘,’ Clinical moderate insomnia’ and ‘Clinical severe’. Results: In the current study, 228 students participated; 172(75.4%) from medical colleges and 56 (24.6%) from non-medical colleges. About 80% of them claimed to have never taken any medications to help them sleep while only three students confirmed their regular use of sleep-inducing medications. About 16% of the students drink milk or other hot drinks to help them fall asleep. None of the students was suspected of having obstructive sleep apnea or apparent psychiatric disorder. According to ISI, 182 (79.8%) students suffered from subthreshold insomnia, 37 (16.2%) had clinical insomnia (moderate severity) and 9 (3.9%) of students had sleeping problems of non-clinically significance level. However, none of students was found to have severe clinical insomnia. Clinical moderate insomnia was reported in 15.1% of medical students and 19.6% of non-medical students. Moreover, about 82% of medical students suffered from subthreshold insomnia compared to 73.2% of non-medical students. This difference was not statistically significant (P=0.24). About 63% of medical students and 48% of non-medical students believed that high percentage of their colleagues are suffering from insomnias (p-value 0.08) The association between GPA and insomnia revealed that; 19.5% of low GPA group compared to 9.3% of high GPA group had clinical moderate insomnia. This association was not statistically significant (p=0.15). The correlation between the GPA and the ISI score was negative but not conclusive (r=-0.08, p-value = 0.29). More than 92% of all students agreed that sleeping problems affect their academic achievement to varying degrees. Conclusion: our results suggest that insomnia is commonly prevalent among female university students and might affect the students’ achievement. This study provides preliminary data about the quality of sleep among medical and non-medical university students which may be used to promote the healthy sleeping habits among female students.

Keywords: academic achievement, females, insomnia, university student

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

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

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

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Authors: K. R. Padma, K. R. Don

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Background and aims: A balanced nutritional diet is essential in maintaining immunity and for deterrence as well as desisting of viral infections. Nevertheless, currently, very less information is available online regarding nutrition consumption during the period of coronavirus infection, i.e. (COVID-19). In our systematic review article, we portrayed and aimed to evaluate evidence from various previous clinical trials, which was based on nutritional interventions for viral diseases and given a concise overview. Methods: A systematic search was carried out employing 3 key medical databases: PubMed®, Web of Science®, and SciVerse Scopus®. Studies were performed and evaluated suitable if clinical trials in humans, appropriate immunological parameters on viral and respiratory infections, need to perform. Basic Clinical trials on nutritional vitamins, minerals, nutraceuticals as well as probiotics were included. Results: We have explored 10 review articles and extracted data for our study. A total of > 2000 participants were included and excluded several other trace elements as well as various vitamins, but in inclusion criteria mainly concentrated on those who have shown propitious immune-modulatory effects against viral respiratory infections. Conclusions: We have encapsulated the potential health benefits of some minerals, vitamins, as well as certain designer foods, nutraceuticals, and probiotics in viral infections. Based on this nutritional interventional strategy available from our present data, it could be promising to abstain and reduce the COVID-19 infection replication and boost our immunity to fight against the virus.

Keywords: COVID-19, immunity, vitamins, nutritional intervention strategy

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Authors: Maria Ahmad, Alexandra Valetopoulou, Michael D. Christian

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Background: London’s Air Ambulance (LAA) provides advanced pre-hospital trauma care across London, bringing specialist resources and expert trauma teams to patients. Since its inception 32 years ago, LAA has treated over 40,000 pre-hospital patients and significantly contributed to pre-hospital patient care in London. To the authors’ best knowledge, this is the first analysis to quantify the magnitude of the publication impact of LAA on the international field of pre-hospital medicine. Method: We searched the Scopus, Web of Science, Google Scholar and PubMed databases to identify LAA focused articles. These were defined as articles on the topic of pre-hospital medicine which either utilised data from LAA, or focused on LAA patients, or were authored by LAA clinicians. A bibliometric analysis was conducted and the impact of each eligible article was classified as either: high (article directly influenced the change or creation of clinical guidelines); medium (the article was referenced in clinical guidelines or had >20 Google Scholar citations or >10 PubMed citations); or low impact (article had <20 Google Scholar citations or <10 PubMed citations). Results: The literature search yielded 1,120 articles in total. 198 articles met our inclusion criteria, and their full text was analysed to determine the level of impact. 19 articles were classified as high-impact, 76 as medium-impact, and 103 as low-impact. 20 of the 76 medium-impact articles were referenced in clinical guidelines but had not prompted changes to the guidelines. Conclusion: To our knowledge, this review is the first to quantify the significant publication impact of LAA within the field of pre-hospital medicine over the last 32 years. LAA publications have focused on and driven clinical innovations in trauma care, particularly in pre-hospital anaesthesia, haemorrhage control, and major incidents, with many impacting national and international guidelines. We recommend a greater emphasis on multidisciplinary pre-hospital collaboration in publications in future research and quality improvement projects across all pre-hospital services.

Keywords: air ambulance, pre-hospital medicine, London’s Air Ambulance, London HEMS

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Authors: Abdesselam Babouri, Ahcène Lemzadmi, M Rahmane, B. Belhadi, N. Abouchi

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Medical monitoring aims at monitoring and remotely controlling the vital physiological parameters of the patient. The physiological sensors provide repetitive measurements of these parameters in the form of electrical signals that vary continuously over time. Various measures allow informing us about the health of the person's physiological data (weight, blood pressure, heart rate or specific to a disease), environmental conditions (temperature, humidity, light, noise level) and displacement and movements (physical efforts and the completion of major daily living activities). The collected data will allow monitoring the patient’s condition and alerting in case of modification. They are also used in the diagnosis and decision making on medical treatment and the health of the patient. This work presents the implementation of a monitoring system to be used for the control of physiological parameters.

Keywords: clinical monitoring, physiological parameters, biomedical sensors, personal health

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Authors: Ayelet Siman-Tov, Shlomo Kaniel

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Objectives: The research validates a multivariate model that predicts parental adjustment to coping successfully with an autistic child. The model comprises four elements: parental stress, parental resources, parental adjustment and the child's autism symptoms. Background and aims: The purpose of the current study is the construction and validation of a model for the adjustment of parents and a child with autism. The suggested model is based on theoretical views on stress and links personal resources, stress, perception, parental mental health and quality of marriage and child adjustment with autism. The family stress approach focuses on the family as a system made up of a dynamic interaction between its members, who constitute interdependent parts of the system, and thus, a change in one family member brings about changes in the processes of the entire family system. From this perspective, a rise of new demands in the family and stress in the role of one family member affects the family system as a whole. Materials and methods: 176 parents of children aged between 6 to 16 diagnosed with ASD answered several questionnaires measuring parental stress, personal resources (sense of coherence, locus of control, social support), adjustment (mental health and marriage quality) and the child's autism symptoms. Results: Path analysis showed that a sense of coherence, internal locus of control, social support and quality of marriage increase the ability to cope with the stress of parenting an autistic child. Directions for further research are suggested.

Keywords: stress, adjustment, resources, Autism, parents, coherence

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Authors: Janet Wing-Chong Wai, Alex Chiu-Wing Lee, Hailey Hoi-Ching Tsang, Jeffrey Chiu, Kwok-Wing Tang

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Background: Mammography has limited sensitivity and specificity though it is the primary imaging technique for detection of early breast cancer. Ultrasound imaging and contrast-enhanced MRI are useful adjunct tools to mammography. The advantage of breast MRI is high sensitivity for invasive breast cancer. Therefore, indications for and use of breast magnetic resonance imaging have increased over the past decade. Objectives: 1. Cases demonstration on different indications for breast MR imaging. 2. To review of the common artifacts and pitfalls in breast MR imaging. Materials and Methods: This is a retrospective study including all patients underwent dynamic contrast-enhanced breast MRI examination in our centre, performed from Jan 2011 to Dec 2017. The clinical data and radiological images were retrieved from the EPR (electronic patient record), RIS (Radiology Information System) and PACS (Picture Archiving and Communication System). Results and Discussion: Cases including (1) Screening of the contralateral breast in patient with a new breast malignancy (2) Breast augmentation with free injection of unknown foreign materials (3) Finding of axillary adenopathy with an unknown site of primary malignancy (4) Neo-adjuvant chemotherapy: before, during, and after chemotherapy to evaluate treatment response and extent of residual disease prior to operation. Relevant images will be included and illustrated in the presentation. As with other types of MR imaging, there are different artifacts and pitfalls that can potentially limit interpretation of the images. Because of the coils and software specific to breast MR imaging, there are some other technical considerations that are unique to MR imaging of breast regions. Case demonstration images will be available in presentation. Conclusion: Breast MR imaging is a highly sensitive and reasonably specific method for the detection of breast cancer. Adherent to appropriate clinical indications and technical optimization are crucial for achieving satisfactory images for interpretation.

Keywords: MRI, breast, clinical, cancer

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Authors: M. Rojo, M. Blanco, T. Lacruz, S. Solano, L. Beltran, M. Graell, A. R. Sepulveda.

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There is an association between an early accumulation of Stressful Life Events (SLE) during childhood and various physical and psychological health complications. However, there are only a few studies on this topic in children and adolescents with overweight or obesity. The general aim of the study was to evaluate the accumulation and type of SLE in 200 children from 8 to 12 years old and analyze the relationship with their emotional well-being and weight status (obesity, overweight and normal weight). The children and their families completed an interview. The evaluated variables that are included in this study are sociodemographic measures, medical/psychological history, anthropometric measures (BMI, z-BMI), and psychological variables (children's clinical interview K-SADS-PL(Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version) and battery of questionnaires). Results: Children with overweight and obesity accumulate more stressful events from an early age and have a significantly higher percentage of psychiatric diagnoses, compared to their peers with normal weight. Presenting a child psychiatric disorder is related to greater z-BMI and the total number of SLE (p < 0.001). A higher z-BMI is also related to a greater number of stressful events during childhood. There is also a positive and significant relationship between the total number of SLE and worse emotional well-being (higher levels of anxious and depressive symptoms and low self-esteem of children) (p < 0.01). Conclusion: Children with overweight and obesity grow up in a family, school, and social context where more stressors are accumulated. This is also directly associated with worse emotional well-being. It is necessary to implement multidisciplinary prevention and intervention strategies in different changes (school, family, and health). This study is included in a project funded by the Ministry of Innovation and Science (PSI2011-23127).

Keywords: childhood obesity, emotional well-being, psychopathology, stressful life events

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Authors: Tugba Sevinc Gamsiz, Emine Koroglu, Ozcan Keskin

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

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

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Authors: Bilal Ahmed

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Rehabilitation of congenital and acquired maxillofacial defects is always a challenging clinical scenario. These defects pose major physiological and psychological threat not only to the patient but to the entire family. There has been an enormous scientific development in maxillofacial rehabilitation with the advent of CAD CAM, 3-D scanning, Osseo-integrated implants and improved restorative materials. There are also specialized centers with latest diagnostic and treatment facilities in the developed countries. However, in certain clinical case scenarios, conventional prosthodontic principles are still the gold standards. Similarly in a less developed world, financial and technical constraints are factors affecting treatment planning and final outcomes. However, we can do a lot of benefits to the affected human beings, even with use of simple and cost-effective conventional prosthodontic techniques and materials. These treatment strategies may sometimes be considered as intermediate or temporary options, but with regular follow-up maintenance these can be used on a definitive basis.

Keywords: maxillofacial defects, obturators, prosthodontics, medical and health sciences

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Authors: Nurul Azmawati Mohamed, Zarini Ismail, Shalinawati Ramli, Nurul Hayati Chamhuri, Nur Syahrina Rahim, K. Omar

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Choosing a career is one of the most important decisions in our life. A right career leads a person to grow with that career and achieve success through the decision. Thus, career suitability assessment is important to help individuals to understand how a variety of personal attributes can impact their potential success and satisfaction with different career options and work environments. Some career needs specific personality trait that relates to attributes of job requirements and commitments. For medicine, being caring, approachable, inquisitive, able to listen and understand patients’ pain, anxiety and sorrow are important. The aim of this study was to evaluate the career suitability of pre-clinical students. This was a cross sectional study conducted among pre-clinical medical students in Universiti Sains Islam Malaysia. 'Sidek Career Interest Inventory’ was used to assess the students’ suitability for the course. This instrument had been validated locally to suit the local social and cultural context. It assessed the students’ personality trait based on Holland’s theory and their interests. For students to pursue in the medical course, two main personality trait are believed to be essential namely investigative and social trait personalities. Some of the characteristics of investigative trait are analytical, rational, intellectual and curious, while the characteristics of social trait personality include empathy, friendly, understanding and accommodating. The score for each personality trait were categorized as low (0-3.99), moderate (4-6.99) and high (7-10). A total of 81 pre-clinical medical students were included in this study. About two third (93.8%) of them were female and all of them are from 20 to 21 of age. Approximately, half of the students (47.5%) scored high and another 46.3% scored moderate for investigative trait. For social trait, only 13.8% scored high while 31.3% scored moderate. Only 12.5% (10) students had high scores for both investigative and social traits. Most of the pre-clinical medical students scored high in the investigative sections, however their social values were inadequate (low scores). For them to become good medical doctors, they should be good in both investigative and social skills to enhance their suitability for this career. Therefore, there is a need to nurture these medical students with appropriate social values and soft skills.

Keywords: career suitability, career interest, medical students, personality trait

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Authors: Shilpa Murthy, Hazlina Binti Abu Bakar, Juliet Mathew, Chandrashekhar Thummala Hlly Sreerama Reddy, Pathiyil Ravi Shankar

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Simulation is defined as a technique that replaces or expands real experiences with guided experiences that interactively imitate real-world processes or systems. Simulation enables learners to train in a safe and non-threatening environment. For decades, simulation has been considered an integral part of clinical teaching and learning strategy in medical education. The several types of simulation used in medical education and the clinical environment can be applied to several models, including full-body mannequins, task trainers, standardized simulated patients, virtual or computer-generated simulation, or Hybrid simulation that can be used to facilitate learning. Simulation allows healthcare practitioners to acquire skills and experience while taking care of patient safety. The recent COVID pandemic has also led to an increase in simulation use, as there were limitations on medical student placements in hospitals and clinics. The learning is tailored according to the educational needs of students to make the learning experience more valuable. Simulation in the pre-clinical years has challenges with resource constraints, effective curricular integration, student engagement and motivation, and evidence of educational impact, to mention a few. As instructors, we may have more reliance on the use of simulation for pre-clinical students while the students’ confidence levels and perceived competence are to be evaluated. Our research question was whether the implementation of simulation-based learning positively influences preclinical medical students' confidence levels and perceived competence. This study was done to align the teaching activities with the student’s learning experience to introduce more low-fidelity simulation-based teaching sessions for pre-clinical years and to obtain students’ input into the curriculum development as part of inclusivity. The study was carried out at International Medical University, involving pre-clinical year (Medical) students who were started with low-fidelity simulation-based medical education from their first semester and were gradually introduced to medium fidelity, too. The Student Satisfaction and Self-Confidence in Learning Scale questionnaire from the National League of Nursing was employed to collect the responses. The internal consistency reliability for the survey items was tested with Cronbach’s alpha using an Excel file. IBM SPSS for Windows version 28.0 was used to analyze the data. Spearman’s rank correlation was used to analyze the correlation between students’ satisfaction and self-confidence in learning. The significance level was set at p value less than 0.05. The results from this study have prompted the researchers to undertake a larger-scale evaluation, which is currently underway. The current results show that 70% of students agreed that the teaching methods used in the simulation were helpful and effective. The sessions are dependent on the learning materials that are provided and how the facilitators engage the students and make the session more enjoyable. The feedback provided inputs on the following areas to focus on while designing simulations for pre-clinical students. There are quality learning materials, an interactive environment, motivating content, skills and knowledge of the facilitator, and effective feedback.

Keywords: low-fidelity simulation, pre-clinical simulation, students satisfaction, self-confidence

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Authors: Sasan Khademnematolahi, Kevine Kamga Silihe, Katarína Pružinská, Martina Chrastina, Elisabeth Louise Ndjengue Mindang, František Dráfi, Katarína Bauerová

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Background: In ethnomedicine, plant parts and compounds are traditionally utilized to treat many disorders. Azadirachta indica, known as Neem, has been traditionally used in medicinal practices. Due to the presence of bioactive substances such as nimbolide, azadirachtin, and gedunin, Neem offers a variety of medicinal properties, including anti-inflammatory and antioxidant properties. Through its effect on pathological inflammatory processes, supplementation with it could alleviate the symptoms of rheumatoid arthritis (RA). Methods: This research aimed to assess Neem seed oil's impact on rats with adjuvant arthritis. Three doses in monotherapy and two in combination with methotrexate (MTX) have been studied, and their effect was compared. Neem p.o. doses of 100, 200, and 300 mg/kg and MTX p.o. doses of 0.3 mg/kg were examined. After clinical parameters assessment, biochemical analysis was performed in plasma. Results: During the acute phase of the experimental arthritis (Day21), levels of MMP-9, MCP-1, and cytokines IL-1beta and IL-17A were measured. The positive results of inflammatory mediators evaluation in plasma encourage additional analysis also in related tissues to prove if Neem seed oil can be used as an adjuvant therapy for RA. Conclusion: In this study, the combination therapy of Neem with MTX was the most effective of all therapies investigated. Acknowledgement: SAIA PROJECT of Kevine Kamga Silihe, Slovakia-Cameroon 2023: “The effect of Crocus sativus L (Saffron), Azadirachta indica (Neem) and their main bioactives compounds in combinatory treatment with methotrexate on experimental arthritis”, VEGA 2/0079/24, VEGA 2/0136/20, VEGA 2/0126/23 and VEGA 2/0091/23.

Keywords: adjuvant, Neem, methotrexate, arthritis

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Authors: Sheikh Omar Sillah

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Introduction: Monitoring is an important means of ensuring the smooth implementation and quality of clinical trials. For many years, traditional site monitoring approaches have been critical in detecting data errors but not optimal in identifying fabricated and implanted data as well as non-random data distributions that may significantly invalidate study results. The objective of this paper was to provide recommendations based on best statistical monitoring practices for detecting data-integrity issues suggestive of fabrication and implantation early in the study conduct to allow implementation of meaningful corrective and preventive actions. Methodology: Electronic bibliographic databases (Medline, Embase, PubMed, Scopus, and Web of Science) were used for the literature search, and both qualitative and quantitative studies were sought. Search results were uploaded into Eppi-Reviewer Software, and only publications written in the English language from 2012 were included in the review. Gray literature not considered to present reproducible methods was excluded. Results: A total of 18 peer-reviewed publications were included in the review. The publications demonstrated that traditional site monitoring techniques are not efficient in detecting data anomalies. By specifying project-specific parameters such as laboratory reference range values, visit schedules, etc., with appropriate interactive data monitoring, statistical monitoring can offer early signals of data anomalies to study teams. The review further revealed that statistical monitoring is useful to identify unusual data patterns that might be revealing issues that could impact data integrity or may potentially impact study participants' safety. However, subjective measures may not be good candidates for statistical monitoring. Conclusion: The statistical monitoring approach requires a combination of education, training, and experience sufficient to implement its principles in detecting data anomalies for the statistical aspects of a clinical trial.

Keywords: statistical monitoring, data anomalies, clinical trials, traditional monitoring

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