Search results for: randomized clinical trials

Authors: Buchh Aqsa, Inayat Umar

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Background- Clonidine, α 2 agonist, possesses several properties to make it valuable adjuvant for spinal anesthesia. The study was aimed to evaluate the clinical effects of oral clonidine premedication for laparoscopic gynecological procedures under subarachnoid block. Patients and method- Sixtyfour adult female patients of ASA physical status I and II, aged 25 to 45 years and scheduled for laparoscopic gynecological procedures under the subarachnoid block, were randomized into two comparable equal groups of 32 patients each to received either oral clonidine, 100 µg (Group I) or placebo (Group II), 90 minutes before the procedure. Subarachnoid block was established with of 3.5 ml of 0.5% hyperbaric bupivacaine in all patients. Onset and duration of sensory and motor block, maximum cephalad level, and the regression time to reach S1 sensory level were assessed as primary end points. Sedation, hemodynamic variability, and respiratory depression or any other side effects were evaluated as secondary outcomes. Results- The demographic profile was comparable. The intraoperative hemodynamic parameters showed significant differences between groups. Oral clonidine was accelerated the onset time of sensory and motor blockade and extended the duration of sensory block (216.4 ± 23.3 min versus 165 ± 37.2 min, P <0.05). The duration of motor block showed no significant difference. The sedation score was more than 2 in the clonidine group as compared to the control group. Conclusion- Oral clonidine premedication has extended the duration of sensory analgesia with arousable sedation. It also prevented the post spinal shivering of the subarachnoid block.

Keywords: oral clonidine, subarachnoid block, sensory analgesia, laparoscopic gynaecological

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Authors: Dan Geneau, Mary Claire Geneau, Seth Lenetsky, Ming -Chang Tsai, Marc Klimstra

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Introduction— Horizontal force-velocity profiling (HFVP) involves modeling an athletes linear sprint kinematics to estimate valuable maximum force and velocity metrics. This approach to performance modeling has been used in field-based team sports and has recently been introduced to ice-hockey as a forward skating performance assessment. While preliminary data has been collected on ice, distance constraints of the on-ice test restrict the ability of the athletes to reach their maximal velocity which result in limits of the model to effectively estimate athlete performance. This is especially true of more elite athletes. This report explores whether athletes on-ice are able to reach a velocity plateau similar to what has been seen in overground trials. Fourteen male Major Junior ice-hockey players (BW= 83.87 +/- 7.30 kg, height = 188 ± 3.4cm cm, age = 18 ± 1.2 years n = 14) were recruited. For on-ice sprints, participants completed a standardized warm-up consisting of skating and dynamic stretching and a progression of three skating efforts from 50% to 95%. Following the warm-up, participants completed three on ice 45m sprints, with three minutes of rest in between each trial. For overground sprints, participants completed a similar dynamic warm-up to that of on-ice trials. Following the warm-up participants completed three 40m overground sprint trials. For each trial (on-ice and overground), radar was used to collect instantaneous velocity (Stalker ATS II, Texas, USA) aimed at the participant’s waist. Sprint velocities were modelled using custom Python (version 3.2) script using a mono-exponential function, similar to previous work. To determine if on-ice tirals were achieving a maximum velocity (plateau), minimum acceleration values of the modeled data at the end of the sprint were compared (using paired t-test) between on-ice and overground trials. Significant differences (P<0.001) between overground and on-ice minimum accelerations were observed. It was found that on-ice trials consistently reported higher final acceleration values, indicating a maximum maintained velocity (plateau) had not been reached. Based on these preliminary findings, it is suggested that reliable HFVP metrics cannot yet be collected from all ice-hockey populations using current methods. Elite male populations were not able to achieve a velocity plateau similar to what has been seen in overground trials, indicating the absence of a maximum velocity measure. With current velocity and acceleration modeling techniques, including a dependency of a velocity plateau, these results indicate the potential for error in on-ice HFVP measures. Therefore, these findings suggest that a greater on-ice sprint distance may be required or the need for other velocity modeling techniques, where maximal velocity is not required for a complete profile.   

Keywords: ice-hockey, sprint, skating, power

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Authors: Polina Prokopovich

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Disease-modifying osteoarthritis drugs (DMOADs) are a new therapeutic class for OA, preventing or inhibiting OA development. Unfortunately, none of the DMOADs have been clinically approved due to their poor therapeutic effects in clinical trials. The joint environment has played a role in the poor clinical performance of these drugs by limiting the amount of drug effectively delivered as well as the time that the drug spends within the joint space. The current study aims to enhance the cartilage uptake and retention time of the DMOADs-model (licofelone), which showed a significant therapeutic effect against OA progression and is currently in phase III. Licofelone will be covalently conjugated to the hydrolysable, cytocompatible, and cationic poly beta-amino ester polymers (PBAE). The cationic polymers (A16 and A87) can be electrostatically attached to the negatively charged cartilage component (glycosaminoglycan), which will increase the drug penetration through the cartilage and extend the drug time within the cartilage. In the cartilage uptake and retention time studies, an increase of 18 to 37 times of the total conjugated licofelone to A87 and A16 was observed when compared to the free licofelone. Furthermore, the conjugated licofelone to A87 was detectable within the cartilage at 120 minutes, while the free licofelone was not detectable after 60 minutes. Additionally, the A87-licofelone conjugate showed no effect on the chondrocyte viability. In conclusion, the cationic A87 and A16 polymers increased the percentage of licofelone within the cartilage, which could potentially enhance the therapeutic effect and pharmacokinetic performance of licofelone or other DMOADs clinically.

Keywords: PBAE, cartilage., osteoarthritis, injectable biomaterials, drug delivery

Procedia PDF Downloads 62

Authors: Woolfrey K., Woolfrey M., Bolton C. L., Warchuk D.

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Objectives: Osteoarthritis is the most common joint disease of adults worldwide. Despite total knee arthroplasty (TKA) demonstrating high levels of success, 20% of patients report dissatisfaction with their result. VOXX Wellness Stasis Socks are embedded with a proprietary pattern of neuro-receptor activation points that have been proven to activate a precise neuro-response, according to the pattern theory of haptic perception, which stimulates improvements in pain and function. The use of this technology in TKA patients may prove beneficial as an adjunct to recovery as many patients suffer from deficits to their proprioceptive system caused by ligamentous damage and alterations to mechanoreceptors during the procedure. We hypothesized that VOXX Wellness Stasis Socks are a safe, cost-effective, and easily scalable strategy to support TKA patients through their recovery. Design: Double-blinded, placebo-controlled randomized trial. Participants: Patients scheduled to receive TKA were considered eligible for inclusion in the trial. Interventions: Intervention group (I): VOXX Wellness Stasis socks containing receptor point-activation technology. Control group (C): VOXX Wellness Stasis socks without receptor point-activation technology. Sock use during the waking hours x 6 weeks. Main Outcome Measures: Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) questionnaire completed at baseline, 2 weeks, and 6 weeks to assess pain, stiffness, and physical function. Results: Data analysis using SPSS software. P-values, effect sizes, and confidence intervals are reported to assess clinical relevance of the finding. Physical status classifications were compared using t-test. Within-subject and between-subject differences in the mean WOMAC were analyzed by ANOVA. Effect size was analyzed using Cramer’s V. Consistent improvement in WOMAC scores for pain and stiffness at 2 weeks post op in the I over the C group. The womac scores assessing physical function showed a consistent improvement at both 2 and 6 weeks post op in the I group compared to C group. Conclusions: VOXX proved to be a low cost, safe intervention in TKA to help patients improve with regard to pain, stiffness, and physical function. Disclosures: None

Keywords: osteoarthritis, RCT, pain management, total knee arthroplasty

Procedia PDF Downloads 519

Authors: Neha P. Amin, Maliha Zainib, Sean Parker, Malcolm Mattes

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Purpose/Objectives: Combination immunotherapy (IT) and radiation therapy (RT) is an actively growing field of clinical investigation due to promising findings of synergistic effects from immune-mediated mechanisms observed in preclinical studies and clinical data from case reports of abscopal effects. While there are many ongoing trials of combined IT-RT, there are still limited data on toxicity and outcome optimization regarding RT dose, fractionation, and sequencing of RT with IT. Nivolumab (NIVO), an anti-PD-1 monoclonal antibody, has been rapidly adopted in the clinic over the past 2 years, resulting in more patients being considered for concurrent RT-NIVO. Knowledge about the toxicity profile of combined RT-NIVO is important for both the patient and physician when making educated treatment decisions. The acute toxicity profile of concurrent RT-NIVO was analyzed in this study. Materials/Methods: A retrospective review of all consecutive patients who received NIVO from 1/2015 to 5/2017 at 4 separate centers within two separate institutions was performed. Those patients who completed a course of RT from 1 day prior to initial NIVO infusion through 1 month after last NIVO infusion were considered to have received concurrent therapy and included in the subsequent analysis. Descriptive statistics are reported for patient/tumor/treatment characteristics and observed acute toxicities within 3 months of RT completion. Results: Among 261 patients who received NIVO, 46 (17.6%) received concurrent RT to 67 different sites. The median f/u was 3.3 (.1-19.8) months, and 11/46 (24%) were still alive at last analysis. The most common histology, RT prescription, and treatment site included non-small cell lung cancer (23/46, 50%), 30 Gy in 10 fractions (16/67, 24%), and central thorax/abdomen (26/67, 39%), respectively. 79% (53/67) of irradiated sites were treated with 3D-conformal technique and palliative dose-fractionation. Grade 3, 4, and 5 toxicities were experienced by 11, 1, and 2 patients, respectively. However all grade 4 and 5 toxicities were outside of the irradiated area and attributed to the NIVO alone, and only 4/11 (36%) of the grade 3 toxicities were attributed to the RT-NIVO. The irradiated site in these cases included the brain [2/10 (20%)] and central thorax/abdomen [2/19 (10.5%)], including one unexpected grade 3 pancreatitides following stereotactic body RT to the left adrenal gland. Conclusions: Concurrent RT-NIVO is generally well tolerated, though with potentially increased rates of severe toxicity when irradiating the lung, abdomen, or brain. Pending more definitive data, we recommend counseling patients on the potentially increased rates of side effects from combined immunotherapy and radiotherapy to these locations. Future prospective trials assessing fractionation and sequencing of RT with IT will help inform combined therapy recommendations.

Keywords: combined immunotherapy and radiation, immunotherapy, Nivolumab, toxicity of concurrent immunotherapy and radiation

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Authors: Catherine Bradshaw

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Educators often report difficulty managing behavior problems and other mental health concerns that students display at school. These concerns also interfere with the learning process and can create distraction for teachers and other students. As such, schools play an important role in both preventing and intervening with students who experience these types of challenges. A number of models have been proposed to serve as a framework for delivering prevention and early intervention services in schools. One such model is called Positive Behavioral Interventions and Supports (PBIS), which has been scaled-up to over 26,000 schools in the U.S. and many other countries worldwide. PBIS aims to improve a range of student outcomes through early detection of and intervention related to behavioral and mental health symptoms. PBIS blends and applies social learning, behavioral, and organizational theories to prevent disruptive behavior and enhance the school’s organizational health. PBIS focuses on creating and sustaining tier 1 (universal), tier 2 (selective), and tier 3 (individual) systems of support. Most schools using PBIS have focused on the core elements of the tier 1 supports, which includes the following critical features. The formation of a PBIS team within the school to lead implementation. Identification and training of a behavioral support ‘coach’, who serves as a on-site technical assistance provider. Many of the individuals identified to serve as a PBIS coach are also trained as a school psychologist or guidance counselor; coaches typically have prior PBIS experience and are trained to conduct functional behavioral assessments. The PBIS team also identifies a set of three to five positive behavioral expectations that are implemented for all students and by all staff school-wide (e.g., ‘be respectful, responsible, and ready to learn’); these expectations are posted in all settings across the school, including in the classroom, cafeteria, playground etc. All school staff define and teach the school-wide behavioral expectations to all students and review them regularly. Finally, PBIS schools develop or adopt a school-wide system to reward or reinforce students who demonstrate those 3-5 positive behavioral expectations. Staff and administrators create an agreed upon system for responding to behavioral violations that include definitions about what constitutes a classroom-managed vs. an office-managed discipline problem. Finally, a formal system is developed to collect, analyze, and use disciplinary data (e.g., office discipline referrals) to inform decision-making. This presentation provides a brief overview of PBIS and reports findings from a series of four U.S. based longitudinal randomized controlled trials (RCTs) documenting the impacts of PBIS on school climate, discipline problems, bullying, and academic achievement. The four RCTs include 80 elementary, 40 middle, and 58 high schools and results indicate a broad range of impacts on multiple student and school-wide outcomes. The session will highlight lessons learned regarding PBIS implementation and scale-up. We also review the ways in which PBIS can help educators and school leaders engage in data-based decision-making and share data with other decision-makers and stakeholders (e.g., students, parents, community members), with the overarching goal of increasing use of evidence-based programs in schools.

Keywords: positive behavioral interventions and supports, mental health, randomized trials, school-based prevention

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Authors: Amin Davoudi

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Aim: New approaches have been introduced to improve soft tissue indices of the dental implants. This systematic review aimed to investigate the effect of computer-aided design and computer-assisted manufacture (CAD/CAM) zirconia (Zr) implant abutments on periodontal aspects. Materials and Methods: Five electronic databases were searched thoroughly based on prior defined MeSH and non-MeSH keywords. Clinical studies were collected via hand searches in English language journals up to September 2020. Interproximal papilla stability, papilla recession, pink and white esthetic score (PES, WES), bone and gingival margin levels, color, and contour of soft tissue were reviewed. Results: The initial literature search yielded 412 articles. After the evaluation of abstracts and full texts, six studies were eligible to be screened. The study design of the included studies was a prospective cohort (n=3) and randomized clinical trial (n=3). The outcome was found to be significantly better for Zr than titanium abutments, however, the studies did not show significant differences between stock and CAD/CAM abutments. Conclusion: Papilla fill, WES, PES, and the distance from the contact point to dental crest bone of adjacent tooth and inter-tooth–implant distance were not significantly different between Zr CAD/CAM and Zr stock abutments. However, soft tissue stability and recession index were better in Zr CAD/CAM abutments.

Keywords: zirconia, CADCAM, periodental, implant

Procedia PDF Downloads 92

Authors: Alexandru Achim, Tamás Szűcsborus, Viktor Sasi, Ferenc Nagy, Zoltán Jambrik, Attila Nemes, Albert Varga, Călin Homorodean, Olivier F. Bertrand, Zoltán Ruzsa

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Aim: Our study aimed to establish the safety and the technical success of distal radial access for balloon aortic valvuloplasty (DR-BAV). The secondary objective was to determine the effectiveness and appropriate role of DR-BAV within half year follow-up. Methods: Clinical and angiographic data from 32 consecutive patients with symptomatic aortic stenosis were evaluated in a prospective pilot single-center study. Between 2020 and 2021, the patients were treated utilizing dual distal radial access with 6-10F compatible balloons. The efficacy endpoint was divided into technical success (successful valvuloplasty balloon inflation at the aortic valve and absence of intra- or periprocedural major complications), hemodynamic success (a reduction of the mean invasive gradient >30%), and clinical success (an improvement of at least one clinical category in the NYHA classification). The safety endpoints were vascular complications (major and minor Valve Academic Research Consortium (VARC)-2 bleeding, diminished or lost arterial pulse or the presence of any pseudo-aneurysm or arteriovenous fistula during the clinical follow-up) and major adverse events, MAEs (the composite of death, stroke, myocardial infarction, and urgent major aortic valve replacement or implantation during the hospital stay and or at one-month follow-up). Results: 32 patients (40 % male, mean age 80 ± 8,5) with severe aortic valve stenosis were included in the study and 4 patients were excluded. Technical success was achieved in all patients (100%). Hemodynamic success was achieved in 30 patients (93,75%). Invasive max and mean gradients were reduced from 73±22 mm Hg and 49±22 mm Hg to 49±19 mm Hg and 20±13 mm Hg, respectively (p = <.001). Clinical success was achieved in 29 patients (90,6%). In total, no major adverse cardiac or cerebrovascular event nor vascular complications (according to VARC 2 criteria) occurred during the intervention. All-cause death at 6 months was 12%. Conclusion: According to our study, dual distal radial artery access is a safe and effective option for balloon aortic valvuloplasty in patients with severe aortic valve stenosis and can be performed in all patients with sufficient lumen diameter. Future randomized studies are warranted to investigate whether this technique is superior to other approaches.

Keywords: mean invasive gradient, distal radial access for balloon aortic valvuloplasty (DR-BAV), aortic valve stenosis, pseudo-aneurysm, arteriovenous fistula, valve academic research consortium (VARC)-2

Procedia PDF Downloads 85

Authors: Hassan Karimi, Fred Piercy, Ruoxi Chen, Ana L. Jaramillo-Sierra, Wei-Ning Chang, Manjushree Palit, Catherine Martosudarmo, Angelito Antonio

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Background: The two psychotherapy camps, the randomized clinical trials (RCTs) and the common factors model, have competitively claimed specific explanations for therapy effectiveness. Recently, scholars called for empirical evidence to show the role of common factors in therapeutic outcome in marriage and family therapy. Purpose: This cross-national study aims to explore how clinicians, across different nations and theoretical orientations, attribute the contribution of common factors to therapy outcome. Method: A brief common factors questionnaire (CFQ-with a Cronbach’s Alpha, 0.77) was developed and administered in seven nations. A series of statistical analyses (paired-samples t-test, independent sample t-test, ANOVA) were conducted: to compare clinicians perceived contribution of total common factors versus model-specific factors, to compare each pair of common factors’ categories, and to compare clinicians from collectivistic nations versus clinicians from individualistic nation. Results: Clinicians across seven nations attributed 86% to common factors versus 14% to model-specific factors. Clinicians attributed 34% of therapeutic change to client’s factors, 26% to therapist’s factors, 26% to relationship factors, and 14% to model-specific techniques. The ANOVA test indicated each of the three categories of common factors (client 34%, therapist 26%, relationship 26%) showed higher contribution in therapeutic outcome than the category of model specific factors (techniques 14%). Clinicians with psychology degree attributed more contribution to model-specific factors than clinicians with MFT and counseling degrees who attributed more contribution to client factors. Clinicians from collectivistic nations attributed larger contributions to therapist’s factors (M=28.96, SD=12.75) than the US clinicians (M=23.22, SD=7.73). The US clinicians attributed a larger contribution to client’s factors (M=39.02, SD=1504) than clinicians from the collectivistic nations (M=28.71, SD=15.74). Conclusion: The findings indicate clinicians across the globe attributed more than two thirds of therapeutic change to CFs, which emphasize the training of the common factors model in the field. CFs, like model-specific factors, vary in their contribution to therapy outcome in relation to specific client, therapist, problem, treatment model, and sociocultural context. Sociocultural expectations and norms should be considered as a context in which both CFs and model-specific factors function toward therapeutic goals. Clinicians need to foster a cultural competency specifically regarding the divergent ways that CFs can be activated due to specific sociocultural values.

Keywords: common factors, model-specific factors, cross-national survey, therapist cultural competency, enhancing therapist efficacy

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Authors: Mahdi Farajzadeh Ajirlou

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The detailed serious adverse effects raised the stresses around the safety of individuals who have gotten COVID-19 vaccines. Numerous verification referrers that disease with COV-19 causes neurological dysfunction in a significant proportion of influenced patients, where these side effects show up seriously amid the disease, and still less is known approximately the potential long-term results for the brain, where the loss of olfaction could be a neurological sign and simple indications of COVID-19. Since publishing effective clinical trial results of mRNA coronavirus disease 2019 (COVID-19) and injecting it to the volunteers in 2020, numerous reports have emerged approximately about cardiovascular complications followed by the mRNA vaccination. Vaccination-associated adenopathy could be a constant imaging finding after the organization of COVID-19 antibodies that will lead to a symptomatic problem in patients with shown or suspected cancer, in whom it may be vague from dangerous nodal inclusion. In spite of all the benefits and viability of the coronavirus infection 2019 (COVID-19) antibodies specified in later clinical trials, a few other post-vaccination side impacts, such as lymphadenopathy (LAP), were observed. Also, numerous variables, including financial conditions, have played a critical part in expanding the number of people with COVID-19 infection and also much more side effects in that country. Amid the Coronavirus widespread, Iran has been experiencing extreme sanctions, which has faced this nation with an extreme financial crisis. Additionally, with COVID-19 widespread, there was a developing concern around the abuse of imaging exams extraordinarily within the pediatric populace, which highlights the issues pointed out by this review.

Keywords: radiology, vaccines, COVID-19, side effect

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Authors: Ghanem Al-Ghamdi

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African Horse Sickness causes significant challenges to horse practitioners and owners in Africa and possibly in certain locations in the Arab Pensila. The aim of this work was to observe a hot spot of epidemic in Al-Baha, Southwestern of Saudi Arabia that could be AHS. A five year-old horse farm that had eight horses with no history of clinical problems was visited in late October 2014. In August 2014, horses showed clinical signs of severe pain, congestion of mucus membranes, foam oozing of the nose, recumbency, difficult breath and ultimately death. The course of the disease averaged 2 days. The farm had no previous history of this episode. Other animals including camel, sheep reside the same farm sharing feeding and water sources however no obvious similar clinical problems were noticed among the two species. Five horses showed the clinical disease and all horses were lost. Veterinary help was not available for diagnosis or treatment. A follow up visit to the farm after one year indicated that the three remaining horses were healthy but were relocated to a different facility out the Al-Baha Region. The most likely cause of such clinical problem is African Horse Sickness, however clinical exam and sampling of other horses in the region is absolute must as well as examining arthropods.

Keywords: African horse sickness, horses, Al-Baha, Saudi Arabia

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Authors: Valerie A. Conrade

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Introduction: A large body of literature suggests patients who complete fecal immunochemical testing (FIT) kits are likely to identify colorectal cancer sooner than those who do not complete FIT kits. Background: Patients who do not participate in preventative measures such as the FIT kit are at a higher risk of colorectal cancer growing unnoticed. The objective was to see if the method the principal investigator (PI) uses to educate clinical staff on the importance of FIT kit administration provides an increased amount of FIT kit dissemination to patients post clinical education. Methodologies: Data collection via manual tallies took place before and after the clinical staff was educated on the importance of FIT kits. Results: The results showed an increase in FIT kit dissemination post clinical staff education. Through enhanced instruction to the clinical staff regarding the importance of FIT kits, expanding their knowledge on preventative measures to detect colorectal cancer positively impacted nurses and, in turn, their patients.

Keywords: colon cancer, education, fecal immunochemical testing, nursing

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Authors: M. Krishna

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The study was intended to identify if scalp cooling therapy is effective on preventing chemotherapy-induced hair loss among cancer patients. Critical literature of non-randomized controlled trials was used to investigate whether scalp cooling therapy is effective on preventing chemotherapy-induced alopecia. The review identified that scalp cooling therapy is effective on preventing chemotherapy-induced alopecia. Most of the patients receiving chemotherapy experience alopecia. It is also perceived as the worst effect of chemotherapy. This may be severe and lead the patients to withdraw the chemo treatment. The image disturbance caused by alopecia will make the patient depressed and will lead to declined immunity. With the knowledge on effectiveness of scalp cooling therapy on preventing chemotherapy-induced alopecia, patient undergoing chemotherapy will not be hesitant to undergo the treatment. Patients are recommended to go through scalp cooling therapy every chemo cycle and the proper therapy duration is 30 minutes before, during chemo. The suggested duration of the scalp cooling therapy is 45-90 minutes for an effective and positive outcome. This finding is excluding other factors of alopecia such as menopause, therapeutic drugs, poor hair density, liver function problems, and drug regimes.

Keywords: alopecia, cancer, chemotherapy, scalp cooling therapy

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Authors: Liana Gomide, Juliana Rodrigues

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The morphology of the foot defines its mode of operation and a biomechanical reform indispensable for a symmetrical distribution of plantar pressures in order not to overload some of its components in isolation. High plantar pressures at specific points in the foot may be a causal factor in several orthopedic disorders that affect the feet such as pain and stress fracture. With digital baro-podometry equipment one can observe an intensity of pressures along the entire foot and quantify some of the movements, such as a subtalar pronation present in the midfoot region. Although, they are involved in microtraumas. In clinical practice, excessive movement has been limited with the use of different taping techniques applied on the plantar arch. Thus, the objective of the present study was to analyze and compare the influence of the inelastic and elastic taping on the distribution of plantar pressure of runners pronators. This is a randomized clinical trial and blind-crossover. Twenty (20) male subjects, mean age 33 ± 7 years old, mean body mass of 71 ± 7 kg, mean height of 174 ± 6 cm, were included in the study. A data collection was carried out by a single research through barop-odometry equipment - Tekscan, model F-scan mobile. The tests were performed at three different times. In the first, an initial barop-odometric evaluation was performed, without a bandage application, with edges at a speed of 9.0 km/h. In the second and third moments, the inelastic or elastic taping was applied consecutively, according to the definition defined in the randomization. As results, it was observed that both as inelastic and elastic taping, provided significant reductions in contact pressure and peak pressure values when compared to the moment without a taping. However, an elastic taping was more effective in decreasing contact pressure (no bandage = 714 ± 201, elastic taping = 690 ± 210 and inelastic taping = 716 ± 180) and no peak pressure in the midfoot region (no bandage = 1490 ± 42, elastic taping = 1273 ± 323 and inelastic taping = 1487 ± 437). It is possible to conclude that it is an elastic taping provided by pressure in the middle region, thereby reducing the subtalar pronunciation event during the run.

Keywords: elastic taping, inelastic taping, running, subtalar pronation

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Authors: Jacqueline Y. Thompson, Sam Watson, Lee Middleton, Karla Hemming

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Introduction: The odds ratio (estimated via logistic regression) is a well-established and common approach for estimating covariate-adjusted binary treatment effects when comparing a treatment and control group with dichotomous outcomes. Its popularity is primarily because of its stability and robustness to model misspecification. However, the situation is different for the relative risk and risk difference, which are arguably easier to interpret and better suited to specific designs such as non-inferiority studies. So far, there is no equivalent, widely acceptable approach to estimate an adjusted relative risk and risk difference when conducting clinical trials. This is partly due to the lack of a comprehensive evaluation of available candidate methods. Methods/Approach: A simulation study is designed to evaluate the performance of relevant candidate methods to estimate relative risks to represent conditional and marginal estimation approaches. We consider the log-binomial, generalised linear models (GLM) with iteratively weighted least-squares (IWLS) and model-based standard errors (SE); log-binomial GLM with convex optimisation and model-based SEs; log-binomial GLM with convex optimisation and permutation tests; modified-Poisson GLM IWLS and robust SEs; log-binomial generalised estimation equations (GEE) and robust SEs; marginal standardisation and delta method SEs; and marginal standardisation and permutation test SEs. Independent and identically distributed datasets are simulated from a randomised controlled trial to evaluate these candidate methods. Simulations are replicated 10000 times for each scenario across all possible combinations of sample sizes (200, 1000, and 5000), outcomes (10%, 50%, and 80%), and covariates (ranging from -0.05 to 0.7) representing weak, moderate or strong relationships. Treatment effects (ranging from 0, -0.5, 1; on the log-scale) will consider null (H0) and alternative (H1) hypotheses to evaluate coverage and power in realistic scenarios. Performance measures (bias, mean square error (MSE), relative efficiency, and convergence rates) are evaluated across scenarios covering a range of sample sizes, event rates, covariate prognostic strength, and model misspecifications. Potential Results, Relevance & Impact: There are several methods for estimating unadjusted and adjusted relative risks. However, it is unclear which method(s) is the most efficient, preserves type-I error rate, is robust to model misspecification, or is the most powerful when adjusting for non-prognostic and prognostic covariates. GEE estimations may be biased when the outcome distributions are not from marginal binary data. Also, it seems that marginal standardisation and convex optimisation may perform better than GLM IWLS log-binomial.

Keywords: binary outcomes, statistical methods, clinical trials, simulation study

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Authors: Monika Bansal

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Background: Placement of dental implant in narrow alveolar ridge is challenging to be treated. GBR procedure is currently most widely used to augment the deficient alveolar ridges and to treat the fenestration and dehiscence around dental implants. Thus, the objectives of the present study were to evaluate as well as compare the clinical performance of collagen membrane and titanium mesh for horizontal bone augmentation at dehisced implant sites. Methods and material: Total 12 single edentulous implant sites with buccal bone deficiency in 8 subjects were equally divided and treated simultaneously with either of the two membranes and DBBM(Bio-Oss) bone graft. Primary outcome measurements in terms of defect height and defect width were made using a calibrated plastic periodontal probe. Re-entry surgery was performed to remeasure the augmented site and to remove Ti-mesh at 6th month. Independent paired t-tests for the inter-group comparison and student-paired t-tests for the intra-group comparison were performed. The differences were considered to be significant at p ≤ 0.05. Results: Mean defect fill with respect to height and width was 3.50 ± 0.54 mm (87%) and 2.33 ± 0.51 mm (82%) for collagen membrane and 3.83 ± 0.75 mm (92%) and 2.50 ± 0.54 mm (88%) for Ti-mesh group respectively. Conclusions: Within the limitation of the study, it was concluded that mean defect height and width after 6 months were statistically significant within the group without significant difference between them, although defect resolution was better in Ti-mesh.

Keywords: collagen membrane, dehiscence, dental implant, horizontal bone, augmentation, ti-mesh

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Authors: Gianna Zou

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Propensity score matching (PSM), introduced by Paul R. Rosenbaum and Donald Rubin in 1983, is a popular statistical matching technique which tries to estimate the treatment effects by taking into account covariates that could impact the efficacy of study medication in clinical trials. PSM can be used to reduce the bias due to confounding variables. However, PSM assumes that the response values are normally distributed. In some cases, this assumption may not be held. In this paper, a machine learning method - Bayesian Additive Regression Tree (BART), is used as a more robust method of matching. BART can work well when models are misspecified since it can be used to model heterogeneous treatment effects. Moreover, it has the capability to handle non-linear main effects and multiway interactions. In this research, a BART Matching Method (BMM) is proposed to provide a more reliable matching method over PSM. By comparing the analysis results from PSM and BMM, BMM can perform well and has better prediction capability when the response values are not normally distributed.

Keywords: BART, Bayesian, matching, regression

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Authors: Eric Lee G. Escobedo-Wu, Nidhi Rohatgi, Fouzel Dhebar

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It is challenging for patients to navigate through healthcare systems after-hours. This leads to delays in care, patient/provider dissatisfaction, inappropriate resource utilization, readmissions, and higher costs. It is important to provide patients and providers with effective clinical decision-making tools to allow seamless connectivity and coordinated care. In August 2015, patient-centric Stanford Health Care established Clinical Advice Services (CAS) to provide clinical decision support after-hours. CAS is founded on key Lean principles: Value stream mapping, empathy mapping, waste walk, takt time calculations, standard work, plan-do-check-act cycles, and active daily management. At CAS, Clinical Assistants take the initial call and manage all non-clinical calls (e.g., appointments, directions, general information). If the patient has a clinical symptom, the CAS nurses take the call and utilize standardized clinical algorithms to triage the patient to home, clinic, urgent care, emergency department, or 911. Nurses may also contact the on-call physician based on the clinical algorithm for further direction and consultation. Since August 2015, CAS has managed 228,990 calls from 26 clinical specialties. Reporting is built into the electronic health record for analysis and data collection. 65.3% of the after-hours calls are clinically related. Average clinical algorithm adherence rate has been 92%. An average of 9% of calls was escalated by CAS nurses to the physician on call. An average of 5% of patients was triaged to the Emergency Department by CAS. Key learnings indicate that a seamless connectivity vision, cascading, multidisciplinary ownership of the problem, and synergistic enterprise improvements have contributed to this success while striving for continuous improvement.

Keywords: after hours phone calls, clinical advice services, nurse triage, Stanford Health Care

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Authors: S. Suman, G. N. Singh

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The present manuscript addresses the estimation procedure of population parameter using Poisson probability distribution when characteristic under study possesses a rare sensitive attribute. The generalized form of unrelated randomized response model is suggested in order to acquire the truthful responses from respondents. The resultant estimators have been proposed for two situations when the information on an unrelated rare non-sensitive characteristic is known as well as unknown. The properties of the proposed estimators are derived, and the measure of confidentiality of respondent is also suggested for respondents. Empirical studies are carried out in the support of discussed theory.

Keywords: Poisson distribution, randomized response model, rare sensitive attribute, non-sensitive attribute

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Authors: Afolabi O.J, Simon-Oke I.A., Oniya M.O., Okaka C.E.

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River blindness is a skin, and an eye disease caused by Onchocerca volvulus and vectored by a female hematophagous blackfly. The study aims to evaluate the distribution of the clinical signs of river blindness and the efficacy of ivermectin in the treatment of river blindness in Idogun. Observational studies in epidemiology that involve the use of a structured questionnaire to obtain useful epidemiological information from the respondents, physical assessment via palpation from head to ankle was used to assess clinical signs from the respondents and skin snip test was used to evaluate the prevalence of the disease. The efficacy of the drug was evaluated and expressed in percentages. One hundred and ninety-two (192) out of the 384 respondents examined, showed various signs of river blindness. However, it was only 108 (28.1%) respondents with the clinical signs that demonstrated Onchocerca volvulus microfilariae in their skin snips. The clinical signs observed among the respondents include skin depigmentation such as dermatitis, leopard skin, papules, pruritus and self-inflicted injury, while ocular symptoms include cataract, ocular lesion and partial blindness. Among these clinical signs, papules, and pruritus were the most dominant in the community. The prevalence of the clinical signs was observed to vary significantly among the age groups and gender (P<0.05). The efficacy of the drug after 6 and 12 months of treatments shows that the drug is more effective at age groups 10-50 years than the age groups 51-90 years. Ivermectin is observed to be efficacious in the treatment of the disease. However, to achieve eradication of the disease, the drug may be administered at 0.15mg/kg twice a year.

Keywords: riverblindness, clinical signs, ivermectin, Idogun

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Authors: Ahmed Yousef A. Al Sultan

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Introduction: The aim of this review is based on clinical research that studies the changes in middle cerebral artery velocity using Transcranial Doppler (TCD) and cerebral oxygen saturation using cerebral oximetry in patients undergoing carotid endarterectomy (CEA) surgery under local anesthesia (LA). Patients with or without neurological symptoms during the surgery are taking a role in this study using triplet method of cerebral oximetry, transcranial doppler and awake test in detecting any cerebral ischemic symptoms. Methods: about one hundred patients took part during their CEA surgeries under local anesthesia, using triple assessment mentioned method, Patients requiring general anesthesia be excluded from analysis. All data were recorded at eight surgery stages separately to serve this study. Results: In total regional cerebral oxygen saturation (rSO2), middle cerebral artery (MCA) velocity, and pulsatility index were significantly decreased during carotid artery clamping step in CEA procedures on the targeted carotid side. With most observed changes in MCA velocity during the study. Discussion: Cerebral oxygen saturation and middle cerebral artery velocity were significantly decreased during clamping step of the procedures on the targeted side. The team with neurological symptoms during the procedures showed higher changes of rSO2 and MCA velocity than the team without neurological symptoms. Cerebral rSO2 and MCA velocity significantly increased directly after de-clamping of the internal carotid artery on the affected side.

Keywords: awake testing, carotid endarterectomy, cerebral oximetry, Tanscranial Doppler

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Authors: Saeed Abbasi, Davood Farsi, Soudabeh Shafiee Ardestani, Neda Valizadeh

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Objectives: Peripheral vertigo is a common complaint of patients who are visited in emergency departments. In our study, we wanted to evaluate the effect of betahistine as an oral drug vs. intravenous diazepam for the treatment of acute peripheral vertigo. We also wanted to see the possibility of substitution of parenteral drug with an oral one with fewer side effects. Materials and Methods: In this randomized, double-blind study, 101 patients were enrolled in the study. The patients were divided in two groups in a double-blind randomized manner. Group A took oral placebo and 10 mg of intravenous diazepam. Group B received 8mg of oral betahistine and intravenous placebo. Patients’ symptoms and signs (Vertigo severity, Nausea, Vomiting, Nistagmus and Gate) were evaluated after 0, 2, 4, 6 hours by emergency physicians and data were collected by a questionnaire. Results: In both groups, there was significant improvement in vertigo (betahistine group P=0.02 and Diazepam group P=0.03). Analysis showed more improvement in vertigo severity after 4 hours of treatment in betahistine group comparing to diazepam group (P=0.02). Nausea and vomiting were significantly lower in patients receiving diazepam after 2 and 6 hours (P=0.02 & P=0.03).No statistically significant differences were found between the groups in nistagmus, equilibrium & vertigo duration. Conclusion: The results of this randomized trial showed that both drugs had acceptable therapeutic effects in peripheral vertigo, although betahistine was significantly more efficacious after 4 hours of drug intake. As for higher nausea and vomiting in betahistine group, physician should consider these side effects before drug prescription.

Keywords: acute peripheral vertigo, betahistine, diazepam, emergency department

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Authors: Abeer Alhazmi

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Introduction: Clinical education is considered a significant part of the learning process for nurses and nursing students. However, recruiting high- caliber individuals to train them to be tomorrow’s educators/teachers has been a recurrent challenge. One of the troubling challenges in this field is the absent of proper training programmes to train educators to be future education professionals and leaders. Aim: To explore the impact of a stage 1 and stage 2 clinical instructor courses on developing leadership skills for nurses as educators.Theoretical Framework: Informed by a symbolic interactionist framework, this research explored the Impact of stage 1 and stage 2 clinical instructor courses on nurses' knowledge, attitudes, and leadership skills. Method: Using Glaserian grounded theory method the data were derived from 3 focus groups and 15 in-depth interviews with nurse educators/clinical instructors and nurses who attended stage 1 and stage 2 clinical instructor courses at King Abdu-Aziz University Hospital (KAUH). Findings: The findings of the research are represented in the core category exploring new identity as educator and its two constituent categories Accepting change, and constructing educator identity. The core and sub- categories were generated through a theoretical exploration of the development of educator’s identity throughout stage 1 and stage 2 clinical instructor courses. Conclusion: The social identity of the nurse educators was developed and changed during and after attending stage 1 and stage 2 clinical instructor courses. In light of an increased understanding of the development process of educators identity and role, the research presents implications and recommendations that may contribute to the development of nursing educators in general and in Saudi Arabia in specific.

Keywords: clinical instructor course, educators, identity work, clinical nursing

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Authors: Dries Dulsster

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This research we want to discuss the implications of the concept of ‘lalangue’ and illustrate its importance for lacanian psychoanalysis and its clinical practice. We will look at this concept through an in depth reading of Lacan’s later seminars, his lectures at the North-American universities and his study on James Joyce. We will illustrate the importance of this concept with a case study from a clinical practice. We will argue that the introduction of ‘lalangue’ has several theoretical and clinical implications that will radically change Lacans teachings. We will illustrate the distinction between language and lalangue. Language serves communication, but this is not the case with lalangue. We will claim that there is jouissance in language and will approach this by introducing the concept of ‘lalangue’. We will ask ourselves what the effect will be of this distinction and how we can use this in clinical practice. The concept of ‘lalangue’ will introduce a new way of thinking about the unconscious. It will force us to no longer view the unconscious as Symbolic, but as Imaginary or Real. Another implication will be the approach on the symptom, no longer approaching it as a formation of the unconscious. It will be renamed as ‘sinthome’, as function of the real. Last of all it will force us to rethink the lacanian interpretation and how we direct the treatment. The implications on a clinical level will be how we think about the lacanian interpretation and the direction of the treatment. We will no longer focus on language and meaning, but focus on jouissance and the ways in which the subject deals with this. We will illustrate this importance with a clinical case study. To summarize, the concept of lalangue forces us to radically rethink lacanian psychoanalysis, with major implications on a theoretical and clinical level. It introduces new concepts such as the real unconscious and the sinthome. It will also make us rethink the way we work as lacanian psychoanalysts.

Keywords: Lacan's later teaching, language, Lalangue, the unconscious

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Authors: Kiran Datta, Daniella Holland-Hart, Anthony Byrne

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Introduction: Oesophago-gastric (OG) cancers are the fifth commonest in the UK, accounting for over 12,000 deaths each year. Most patients will present at later stages of the disease, with only 21% of patients with stage 4 disease surviving longer than a year. As a result, many patients are unsuitable for curative surgery and instead receive palliative treatment to improve prognosis and symptom burden. However, palliative chemotherapy can result in significant toxicity: almost half of the patients are unable to complete their chemotherapy regimen, with this proportion rising significantly in older and frailer patients. In addition, clinical trials often exclude older and frailer patients due to strict inclusion criteria, meaning there is limited evidence to guide which patients are most likely to benefit from palliative chemotherapy. Inappropriate chemotherapy administration is at odds with the goals of palliative treatment and care, which are to improve quality of life, and this also represents a significant resource expenditure. This literature review aimed to examine and appraise evidence regarding treatment resilience in order to guide clinicians in identifying the most suitable candidates for palliative chemotherapy. Factors influencing treatment resilience were assessed, as measured by completion rates, dose reductions, and toxicities. Methods: This literature review was conducted using rapid review methodology, utilising modified systematic methods. A literature search was performed across the MEDLINE, EMBASE, and Cochrane Library databases, with results limited to papers within the last 15 years and available in English. Key inclusion criteria included: 1) participants with either oesophageal, gastro-oesophageal junction, or gastric cancers; 2) patients treated with palliative chemotherapy; 3) available data evaluating the association between baseline participant characteristics and treatment resilience. Results: Of the 2326 papers returned, 11 reports of 10 studies were included in this review after excluding duplicates and irrelevant papers. Treatment resilience factors that were assessed included: age, performance status, frailty, inflammatory markers, and sarcopenia. Age was generally a poor predictor for how well patients would tolerate chemotherapy, while poor performance status was a better indicator of the need for dose reduction and treatment non-completion. Frailty was assessed across one cohort using multiple screening tools and was an effective marker of the risk of toxicity and the requirement for dose reduction. Inflammatory markers included lymphopenia and the Glasgow Prognostic Score, which assessed inflammation and hypoalbuminaemia. Although quick to obtain and interpret, these findings appeared less reliable due to the inclusion of patients treated with palliative radiotherapy. Sarcopenia and body composition were often associated with chemotherapy toxicity but not the rate of regimen completion. Conclusion: This review demonstrates that there are numerous measures that can estimate the ability of patients with oesophago-gastric cancer to tolerate palliative chemotherapy, and these should be incorporated into clinical assessments to promote personalised decision-making around treatment. Age should not be a barrier to receiving chemotherapy and older and frailer patients should be included in future clinical trials to better represent typical patients with oesophago-gastric cancers. Decisions regarding palliative treatment should be guided by these factors identified as well as patient preference.

Keywords: frailty, oesophago-gastric cancer, palliative chemotherapy, treatment resilience

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Authors: Susan Ka Yee Chow

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Effective clinical preceptorship is affecting students’ competence and fostering their growth in applying theoretical knowledge and skills in clinical settings. Any difference between the expected and actual learning experience will reduce nursing students’ interest in clinical practices and having a negative consequence with their clinical performance. This cross-sectional study is an attempt to compare the differences between preferred and actual preceptorship experience of final year nursing students, and to examine the relationship between the actual preceptorship experience and perceived clinical competence of the students in a tertiary institution. Participants of the study were final year bachelor nursing students of a self-financing tertiary institution in Hong Kong. The instruments used to measure the effectiveness of clinical preceptorship was developed by the participating institution. The scale consisted of five items in a 5-point likert scale. The questions including goals development, critical thinking, learning objectives, asking questions and providing feedback to students. The “Clinical Competence Questionnaire” by Liou & Cheng (2014) was used to examine students’ perceived clinical competences. The scale consisted of 47 items categorized into four domains, namely nursing professional behaviours; skill competence: general performance; skill competence: core nursing skills and skill competence: advanced nursing skills. There were 193 questionnaires returned with a response rate of 89%. The paired t-test was used to compare the differences between preferred and actual preceptorship experiences of students. The results showed significant differences (p<0.001) for the five questions. The mean for the preferred scores is higher than the actual scores resulting statistically significance. The maximum mean difference was accepted goal and the highest mean different was giving feedback. The Pearson Correlation Coefficient was used to examine the relationship. The results showed moderate correlations between nursing professional behaviours with asking questions and providing feedback. Providing useful feedback to students is having moderate correlations with all domains of the Clinical Competence Questionnaire (r=0.269 – 0.345). It is concluded that nursing students do not have a positive perception of the clinical preceptorship. Their perceptions are significantly different from their expected preceptorship. If students were given more opportunities to ask questions in a pedagogical atmosphere, their perceived clinical competence and learning outcomes could be improved as a result.

Keywords: clinical preceptor, clinical competence, clinical practicum, nursing students

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Authors: Somruay Apichatibutarapong, Chookiat Pudprommart

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The purpose of this study was to develop of statistical analysis by using R programming via internet applied for agriculture experimental design. Data were collected from 65 items in completely randomized design, randomized block design, Latin square design, split plot design, factorial design and nested design. The quantitative approach was used to investigate the quality of learning media on statistical analysis by using R programming via Internet by six experts and the opinions of 100 students who interested in experimental design and applied statistics. It was revealed that the experts’ opinions were good in all contents except a usage of web board and the students’ opinions were good in overall and all items.

Keywords: experimental design, r programming, applied statistics, statistical analysis

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Authors: Phang Moon Leng

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Automated Early Warning Scores is a newly developed clinical decision tool that is used to streamline and improve the process of obtaining a patient’s vital signs so a clinical decision can be made at an earlier stage to prevent the patient from further deterioration. This technology provides immediate update on the score and clinical decision to be taken based on the outcome. This paper aims to study the use of an automated early warning score system on whether the technology has assisted the hospital in early detection and escalation of clinical condition and improve patient outcome. The hospital adopted the Modified Early Warning Scores (MEWS) Scoring System and MEWS Clinical Response into Philips IntelliVue Guardian Automated Early Warning Score equipment and studied whether the process has been leaned, whether the use of technology improved the usage & experience of the nurses, and whether the technology has improved patient care and outcome. It was found the steps required to obtain vital signs has been significantly reduced and is used more frequently to obtain patient vital signs. The number of deaths, and length of stay has significantly decreased as clinical decisions can be made and escalated more quickly with the Automated EWS. The automated early warning score equipment has helped improve work efficiency by removing the need for documenting into patient’s EMR. The technology streamlines clinical decision-making and allows faster care and intervention to be carried out and improves overall patient outcome which translates to better care for patient.

Keywords: automated early warning score, clinical quality and safety, patient safety, medical technology

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Authors: Zohra Benfodda, Valentin Duvauchelle, Chaimae Majdi, David Bénimélis, Catherine Dunyach-Remy, Patrick Meffre

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New antibiotics are necessary to treat microbial pathogens, especially ESKAPE pathogens that are becoming increasingly resistant to available treatment. Despite the medical need, the number of newly approved drugs continues to decline. The majority of antibiotics under clinical development are natural products or derivatives thereof. 43 juglone/naphthazarin derivatives were synthesized using Minisci-type direct C–H alkylation and evaluated for their antibacterial properties against various clinical and reference Gram-positive MSSA, clinical Gram-positive MRSA. Different compounds of the synthesized series showed promising activity against clinical and reference MSSA (MIC: 1–8 μg/ml) and good efficacy against clinical MRSA (MIC: 2–8 μg/ml) strains. The synergistic effects of active compounds were evaluated with reference antibiotics (vancomycin and cloxacillin), and it was found that the antibiotic combination with those active compounds efficiently enhanced the antimicrobial activity and consequently the MIC values of reference antibiotics were lowered up to 1/16th of the original MIC. These synthesized compounds did not present hemolytic activity on sheep red blood cells. In addition to the in silico prediction of ADME profile parameter which is promising and encouraging for further development.

Keywords: juglone, naphthazarin, antibacterial, clinical MRSA, synergistic studies, MIC determination

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Authors: Mohd Asharf Ganie, Aafia Rashid, Mohd Afzal Zargar, Showkat Ali Zargar, Syed Mudasar, Tabasum Parvaiz, Zafar Amin Shah

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Accumulating evidence suggests that Vitamin D deficiency (VDD) might at least contribute to the metabolic co-morbidities in PCOS. Hence, we aimed to study the effect of vitamin D supplementation in co-prescription with insulin sensitizers like metformin and pioglitazone on clinical, hormonal and metabolic parameters in women with PCOS. In this open label randomized, controlled trial a total of 120 women with PCOS diagnosis (AE-PCOS 2009 Criteria) were assigned to four treatment groups (n= 30 in each): group I (metformin 1 gm/day in combination with cholecalciferol 4000 IU/day), group II (pioglitazone 30 mg/day in combination with cholecalciferol 4000 IU/day), group III (metformin 1 gm /day) and group IV (pioglitazone 30 mg/day). Vitamin D supplementation was given as 60,000 units every two weeks for 24 weeks. All the subjects were routinely evaluated for clinical, biochemical, hormonal and insulin sensitivity parameters in addition to various safety parameters especially serum calcium levels at baseline and after 24 weeks of the treatment. Our results indicate that 95.5% of PCOS women were vitamin D deficient at baseline. Serum 25 (OH) D levels increased significantly (p < 0.001) in groups I and II without any adverse effects after 24 weeks of oral administration of 4000 IU cholecalciferol daily. However, serum 25 (OH) D levels remained unchanged in group III and IV. By six months, number of menstrual cycles per year increased whereas Ferriman-Gallwey score, serum total testosterone and HOMA-IR decreased significantly (P < 0.001) in the treatment groups supplemented with cholecalciferol as compared to those treated either drug alone. No significant beneficial changes were observed on weight, BMI, blood pressure, glucose tolerance and serum lipids in any of the groups supplemented with cholecalciferol. We conclude that daily dose of 4000 IU cholecalciferol might be a useful adjunct in complex treatment of PCOS with fewer adverse events. Furthermore, pioglitazone and cholecalciferol combination seems to be marginally better although there was no statistical significance.

Keywords: PCOS, vitamin D supplementation, insulin resistance, spironolactone, metformin, pioglitazone

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