Search results for: clinical trial development

Authors: Mamdouh Milad Adly Morkos

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

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

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Authors: Yong Cang

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RJV001 is a subcutaneous injection containing mutated recombinant Collagenase H (ColH), leading to disruption of collagen matrix in adipose tissue and programmed cell death of adipocytes. Here we reported our clinical investigation of the safety, tolerance and pharmacodynamics of localized RJV001 injection into healthy human abdominal fat tissues (NCT04821648, Arizona Research Center). Investigate the safety, tolerance and clinical pharmacodynamics of subcutaneous RJV001 in humans. In the dose-escalating study, 18 subjects completed the study, 100% female, 78% white, with a mean age of 42[±9.9]. All three tested dose (0.05, 0.075 and 0.15 mg/injection), up to 30 injections, were safe and well-tolerated. Bruising and tenderness to palpation, mild to moderate, were the most frequent local skin reactions but nearly all resolved within 30 days. Additionally, physician-monitored ultrasound measurement showed that a reduction in abdominal fat tissue thickness was consistently observed in Cohort C (0.075, 0.15 mg/injection, 30injections), with a mean reduction of 7.37 [± 2.020] mm. Based on this clinical study, RJV001 has been advanced to phase II clinical studies. In the dose-escalating study, subcutaneously administered RJV001 was safe and well-tolerated in healthy adults up to 0.15 mg/injection, 30 injections. Fat reduction and adipocytolysis were observed by ultrasound measurements and histological analysis for exploratory purposes.

Keywords: fat reduction, mutant collagenase, clinical trial, subcutaneous injection

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Authors: Asaf Toker

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Matricelf developed a technology that enables the production of autologous engineered tissue composed of matrix and cells derived from patients Omentum biopsy. The platform showed remarkable pre-clinical results for several medical conditions. The company recently licensed the technology that enabled scientist at Tel Aviv university that 3D printed a human heart from human cells and matrix for the first time in human history. The company plans to conduct its first human clinical trial for Acute Spinal Cord Injury (SCI) early in 2023.

Keywords: tissue engineering, regenerative medicine, spinal Cord Injury, autologous implants, iPSC

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Authors: Nittaya Nokham, Nattaphon Kamon, Pipatpong Pimkhot, Pedcharada Yusuk

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Testing efficacy of a bio-product (bp) to reduce amount of arsenic was carried out in soil which were used for cultivation of organic vegetables, at Watchan Royal Project Development Center, Kulayaniwattana district, Chiang Mai. The test consists of 6 treatments e.g. Tr.1) Control: To underlie the planting pits (pp)with compost; Tr.2) Using bp: To underlie thepp with compost mixed with (+) bp at 100 g/pit; Tr.3) Using bp: To underlie the pp with compost + bp at 100 g/pit and to spray the vegetables with bp at 2 l/20 l of water, once a week; Tr.4) Using bp: To spread the compost bp on the planting area at 3 kg/1 m2 ; Tr.5) Using bp: To spread the compost + bp on the planting area at 3 kg/1 m2and to spray vegetables with bp at 2 l/20 l of water; Tr.6) Using bp: To spray vegetables with bp at 2 l/20 l of water. Result showed that after first trial of pointed cabbage cultivation, only Tr.6 had a small reduction of arsenic; while the others had higher amount of the metal. After second trial of growing red oak leaf, Tr.6 had more reduction of arsenic while Tr.5 and Tr.3 had less reduction compared to Tr.6 but more reduction than the others. In the third trial of growing mustard, very small reduction could be found on Tr.6 and Tr.5 but more reduction in Tr.3. For the fourth (last) trial with cos romaine lettuce: Tr.6, Tr.5 showed most reduction of arsenic to about half of the original amount. So, it can be concluded that this bio-product can help reducing arsenic when using this product by spraying the bp to vegetables at concentration of 2 l/20 l of water once week (Tr.6), or using the bio-product mixed with compost to spread on the planting area at 3 kg/1 m2 together with spraying the product (Tr.5). The results obtained from continuous planting 4 kinds of vegetables at the same area. The amount of arsenic found in roots and stem is very small in the 4 vegetables.

Keywords: organic vegetables, bio-product, arsenic, soil

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Authors: B. Yermekbayeva, A. Gulyayaev, T. Nurgozhin, C. Bektur

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Cytisine aminophosphonate under the name "Cytafat" was approved for clinical trials in Republic of Kazakhstan as a putative liver protecting drug for the treatment of acute toxic hepatitis. A method of conducting the clinical trial is a double blind study. Total number of patients -71, aged from 16 to 56 years. Research on healthy volunteers determined the maximal tolerable doze of "Cytafat" as 200 mg/kg. Side effects when administered at high dozes (100-200 mg/kg) are tachycardia and increase of arterial blood pressure. The drug is tested in the treatment of 28 patients with a syndrome of hepatocellular failure (a poisoning with substitutes of alcohol, rat poison, or medical products). "Cytafat" was intravenously administered at a dose of 10 mg/kg in 200 ml of 5 % glucose solution once daily. The number of administrations: 1-3. In the comparison group, 23 patients were treated intravenously once a day with “Essenciale H” at a dose of 10 ml. 20 patients received a placebo (10 ml of glucose intravenously). In all cases of toxic hepatopathology the significant positive clinical effect of the testing drug distinguishable from placebo and surpassing the alternative was observed. Within a day after administration a sharp reduction of cytolitic syndrome parameters (ALT, AST, alkaline phosphatase, thymol turbidity test, GGT) was registered, a reduction of the severity of cholestatic syndrome (bilirubin decreased) was recorded, significantly decreased indices of lipid peroxidation. The following day, in all cases the positive dynamics was determined with ultrasound study (reduction of diffuse changes and events of reactive pancreatitis), hepatomegaly disappeared. Normalization of all parameters occurred in 2-3 times faster, than when using the drug "Essenciale H" and placebo. Average term of elimination of toxic hepatopathy when using the drug "Cytafat" -2,8 days, "Essenciale H" -7,2 days, and placebo -10,6 days. The new drug "Cytafat" has expressed cytoprotective properties.

Keywords: cytisine, cytoprotection, hepatopathy, hepatoprotection

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Authors: Lucile Rapin, Cynthia El Hage, Rihab Gamaoun, Maria-Fernanda Arboleda, Erin Prosk

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Introduction: Sante Cannabis (SC), a Canadian group of clinics dedicated to medical cannabis, based in Montreal and in the province of Quebec, has served more than 8000 patients seeking cannabis-based treatment over the past five years. As randomized clinical trials with natural medical cannabis are scarce, real-world evidence offers the opportunity to fill research gaps between scientific evidence and clinical practice. Data on the use of medical cannabis products from SC patients were prospectively collected, leading to a large real-world database on the use of medical cannabis. The aim of this study was to report information on the profiles of both patients and prescribed medical cannabis products at SC clinics, and to assess the safety of medical cannabis among Canadian patients. Methods: This is an observational retrospective study of 1342 adult patients who were authorized with medical cannabis products between October 2017 and September 2019. Information regarding demographic characteristics, therapeutic indications for medical cannabis use, patterns in dosing and dosage form of medical cannabis and adverse effects over one-year follow-up (initial and 4 follow-up (FUP) visits) were collected. Results: 59% of SC patients were female, with a mean age of 56.7 (SD= 15.6, range= (19-97)). Cannabis products were authorized mainly for patients with a diagnosis of chronic pain (68.8% of patients), cancer (6.7%), neurological disorders (5.6%), and mood disorders (5.4 %). At initial visit, a large majority (70%) of patients were authorized exclusively medical cannabis products, 27% were authorized a combination of pharmaceutical cannabinoids and medical cannabis and 3% were prescribed only pharmaceutical cannabinoids. This pattern was recurrent over the one-year follow-up. Overall, oil was the preferred formulation (average over visits 72.5%) followed by a combination of oil and dry (average 19%), other routes of administration accounted for less than 4%. Patients were predominantly prescribed products with a balanced THC:CBD ratio (59%-75% across visits). 28% of patients reported at least one adverse effect (AE) at the 3-month follow-up visit and 12% at the six-month FUP visit. 84.8% of total AEs were mild and transient. No serious AE was reported. Overall, the most common side effects reported were dizziness (11.95% of total AEs), drowsiness (11.4%), dry mouth (5.5%), nausea (4.8%), headaches (4.6%), cough (4.4%), anxiety (4.1%) and euphoria (3.5%). Other adverse effects accounted for less than 3% of total AE. Conclusion: Our results confirm that the primary area of clinical use for medical cannabis is in pain management. Patients in this cohort are largely utilizing plant-based cannabis oil products with a balanced ratio of THC:CBD. Reported adverse effects were mild and included dizziness and drowsiness. This real-world data confirms the tolerable safety profile of medical cannabis and suggests medical indications not yet validated in controlled clinical trials. Such data offers an important opportunity for the investigation of the long-term effects of cannabinoid exposure in real-life conditions. Real-world evidence can be used to direct clinical trial research efforts on specific indications and dosing patterns for product development.

Keywords: medical cannabis, safety, real-world data, Canada

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Authors: Nalanda Roy

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The project will offer a fresh and critical perspective into the Tokyo Trial judgment led by the Indian Jurist Dr. Radha Binod Pal. The project will focus on the Third World Approach to International Law (TWAIL) methodology to examine the relevance of international law from the post-colonial perspectives. The project will analyze Pal’s dissenting arguments from a new and comparative perspective, apply for work from other disciplines, and create an understanding of the significance of the historic judgment considering its contemporary relevance, and fill in the gaps that exist in the call for global justice.

Keywords: Tokyo trial, third world, judgment, international law

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Authors: Erinda Male

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Participation of a lawyer in any criminal proceedings on behalf of an accused person or a victim is essential to a fair trial. Legal representation is particularly crucial in proceedings before international tribunals, especially in the International Criminal Court. The paper thus focuses on the importance of the legal representation of victims and defendants before the ICC, as well as on the role of the legal representative in the proceedings before the court and the principle of freedom of choice of legal representatives. Also, the paper presents a short overview of the significance of legal representatives for victims and the necessity to protect their primary role in the ICC system, and ensure that it is coherent and respectful of victims’ rights. Victim participation is an important part of the ICC Statute and it is designed to help ensure that those most affected by the crimes are able to engage with the Court. Proper and quality legal representation ensures meaningful participation of victims at stages of the proceedings before ICC. Finally, the paper acknowledges the role of legal representatives during the pre-trial, trial and post-trial phase, the different modalities in selecting the legal representatives as well as balancing victims’ participation with the right of the accused to a fair trial.

Keywords: fair trial, freedom of choice principle, international criminal court, legal representatives, victims

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Authors: Ramy Shaaban

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

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

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Authors: Teris Cheung, Joyce Yuen Ting Lam, Kwan Hin Fong, Yuen Shan Ho, Tim Man Ho Li, Andy Choi-Yeung Tse, Cheng-Ta Li, Calvin Pak-Wing Cheng, Roland Beisteiner

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Transcranial pulse stimulation (TPS) is a non-intrusive brain stimulation technology that has been proven effective in older adults with mild neurocognitive disorders and adults with major depressive disorder. Given these robust evidences, TPS might be an adjunct treatment options in neuropsychiatric disorders, for example, autism spectrum disorder (ASD) – which is a common neurodevelopmental disorder in children. This trial aimed to investigate the effects of TPS on right temporoparietal junction, a key node for social cognition for Autism Spectrum Disorder (ASD), and to examine the association between TPS, executive functions and social functions. Design: This trial adopted a two-armed (verum TPS group vs. sham TPS group), double-blinded, randomized, sham-controlled design. Sampling: 32 subjects aged between 12 and 17, diagnosed with ASD were recruited. All subjects were computerized randomized into either verum TPS group or the sham TPS group on a 1:1 ratio. All subjects undertook functional MRI before and after the TPS interventions. Intervention: Six 30-min TPS sessions were administered to subjects in 2 weeks’ time on alternate days assessing neural connectivity changes. Baseline measurements and post-TPS evaluation of the ASD symptoms, executive functions, and social functions were conducted. Participants were followed up at 2-weeks, at 1-month and 3-month, assessing the short-and long-term sustainability of the TPS intervention. Data analysis: Generalized Estimating Equations with repeated measures were used to analyze the group and time difference. Missing data were managed by multiple imputations. The level of significance was set at p < 0.05. To our best knowledge, this is the first study evaluating the efficacy and safety of TPS among adolescents with ASD in Hong Kong and nationwide. Results emerging from this study will develop insight on whether TPS can be used as an adjunct treatment on ASD in neuroscience and clinical psychiatry. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT05408793.

Keywords: adolescents, autism spectrum disorder, neuromodulation, rct, transcranial pulse stimulation

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Authors: Alok Madan, Arshad K. Hashmi

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Performance based design (PBD) is an iterative exercise in which a preliminary trial design of the building structure is selected and if the selected trial design of the building structure does not conform to the desired performance objective, the trial design is revised. In this context, development of a fundamental approach for performance based seismic design of masonry infilled frames with minimum number of trials is an important objective. The paper presents a plastic design procedure based on the energy balance concept for PBD of multi-story multi-bay masonry infilled reinforced concrete (R/C) frames subjected to near-field earthquakes. The proposed energy based plastic design procedure was implemented for trial performance based seismic design of representative masonry infilled reinforced concrete frames with various practically relevant distributions of masonry infill panels over the frame elevation. Non-linear dynamic analyses of the trial PBD of masonry infilled R/C frames was performed under the action of near-field earthquake ground motions. The results of non-linear dynamic analyses demonstrate that the proposed energy method is effective for performance based design of masonry infilled R/C frames under near-field as well as far-field earthquakes.

Keywords: masonry infilled frame, energy methods, near-fault ground motions, pushover analysis, nonlinear dynamic analysis, seismic demand

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Authors: Kasra Afsahi, Maryam Soheilifar, S. Hossein Hosseini, Omid Seyed Esmaeili, Rouzbeh Kezemi, Noushin Mehrbod, Nazanin Vahed, Tahereh Hajiahmad, Noureddin Nakhostin Ansari

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Background: Stroke is a disabling neurological disease. Rehabilitative therapies are important treatment methods. This clinical trial was done to compare the effects of VR beside conventional rehabilitation versus conventional rehabilitation alone on spasticity and motor function in stroke patients. Materials and Methods: In this open-label randomized controlled clinical trial, 40 consecutive patients with stable first-ever ischemic stroke in the past three to 12 months that were referred to a rehabilitation clinic in Tehran, Iran, in 2020 were enrolled. After signing the informed written consent form, subjects were randomly assigned by block randomization of five in each block as cases with 1:1 into two groups of 20 cases; conventional plus VR therapy group: 45-minute conventional therapy session plus 15-minute VR therapy, and conventional group: 60-minute conventional therapy session. VR rehabilitation is designed and developed with different stages. Outcomes were modified Ashworth scale, recovery stage score for motor function, range of motion (ROM) of shoulder abduction/wrist extension, and patients’ satisfaction rate. Data were compared after study termination. Results: The satisfaction rate among the patients was significantly better in the combination group (P=0.003). Only wrist extension was varied between groups and was better in the combination group. The variables generally had a statistically significant difference (P < 0.05). Conclusion: Virtual reality plus conventional rehabilitation therapy is superior versus conventional rehabilitation alone on the wrist and elbow spasticity and motor function in patients with stroke.

Keywords: stroke, virtual therapy, rehabilitation, treatment

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Authors: Nahla Al-Bayyari, Rae’d Hailat

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Vitamin D deficiency and overweight are common in women suffering from polycystic ovary syndrome (PCOS). Weight gain in PCOS is an important factor for the development of menstrual dysfunction and signs of hyperandrogenism and alopecia. Features of PCOS such as oligomenorrhea can be predicted by anthropometric measurements as body mass index (BMI). Therefore, the aim of this trial was to study the effect of 50,000 IU/week of vitamin D₃ supplementation on the body composition and on the anthropometric measurements of overweight women with PCOS and to examine the impact of this effect on ovaries ultrasonography and menstrual cycle regularity. The study design was a prospective randomized, double-blinded placebo-controlled clinical trial conducted on 60 overweight Jordanian women aged (18-49) years with PCOS and vitamin D deficiency. The study participants were divided into two groups; vitamin D group (n = 30) who were assigned to receive 50,000 IU/week of vitamin D₃ and placebo group (n = 30) who were assigned to receive placebo tablets orally for 90 days. The anthropometric measurements and body composition were measured at baseline and after treatment for the PCOS and vitamin D deficient women. Also, assessment of the participants’ picture of ovaries by ultrasound and menstrual cycle regulatory were performed before and after treatment. Results showed that there were no significant (p > 0.05) differences between the placebo and vitamin D group basal 25(OH)D levels, body composition and anthropometric parameters. After treatment, vitamin D group serum levels of 25(OH)D increased (12.5 ± 0.61 to 50.2 ± 2.04 ng/mL, (p < 0.001), and decreased (50.2 ± 2.04 to 48.2 ± 2.03 ng/mL, p < 0.001) after 14 days of vitamin D₃ treatment cessation. There were no significant changes in the placebo group. In the vitamin D group, there were significant (p < 0.001) decreases in body weight, BMI, waist, and hip circumferences and fat mass. In addition, there were significant increases (p < 0.05) in fat free mass and total body water. These improvements in both anthropometric and body composition as well as in 25(OH)D concentrations, resulted in significant improvements in the picture of PCOS women ovaries ultrasonography and in menstrual cycle regularity, where nearly most of them (93%) had regular cycles after vitamin D₃ supplementation. In the placebo group, there were only significant decreases (p < 0.05) in waist and hip circumferences. It can be concluded that vitamin D supplementation improving serum 25(OH)D levels and PCOS prognosis by reducing body weight of overweight PCOS women and regulating their menstrual cycle.

Keywords: anthropometric, overweight, polycystic ovary syndrome, vitamin D₃

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Authors: Muhammad Shafi’U Adamu

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This study examined the effects of two groups of Cognitive Behavioral Therapies (CBT) which, includes Cognitive Restructuring (CB) and Rational Emotive Behavioral Therapy (REBT), on the Psychological Distress of awaiting-trial Inmates in Correctional Centers in North-West Nigeria. The study had four specific objectives, four research questions, and four null hypotheses. The study used a quasi-experimental design that involved pre-test and post-test. The population comprised of all 7,962 awaiting-trial inmates in correctional centers in North-west Nigeria. 131 awaiting trial inmates from three intact Correctional Centers were randomly selected using the census technique. The respondents were sampled and randomly put into 3 groups (CR, REBT and Control). Kessler Psychological Distress Scale (K10) was adapted for data collection in the study. The instrument was validated by experts and subjected to a pilot study using Cronbach's Alpha with a reliability coefficient of 0.772. Each group received treatment for 8 consecutive weeks (60 minutes/week). Data collected from the field were subjected to descriptive statistics of mean, standard deviation and mean difference to answer the research questions. Inferential statistics of ANOVA and independent sample t-test were used to test the null hypotheses at P≤ 0.05 level of significance. Results in the study revealed that there was no significant difference among the pre-treatment mean scores of experimental and control groups. Statistical evidence also showed a significant difference among the mean scores of the three groups, and thus, results of the Post Hoc multiple-comparison test indicated the posttreatment reduction of psychological distress in the awaiting-trial inmates. Documented output also showed a significant difference between the post-treatment psychologically distressed mean scores of male and female awaiting-trial inmates, but there was no difference in those exposed to REBT. The research recommends that a standardized structured CBT counseling technique treatment should be designed for correctional centers across Nigeria, and CBT counseling techniques could be used in the treatment of PD in both correctional and clinical settings.

Keywords: awaiting-trial inmates, cognitive restructuring, correctional centers, rational emotive behavioral therapy

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Authors: Mohammad Javad Zehtab, S. Alireza Mirghasemi, Ali Majlesara, Parvin Tajik, Babak Siavashi

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Objective: There are different modalities proposed for tennis elbow treatment with few randomized trials comparing them. We designed a study to compare the effectiveness of five different modalities and determine the usefulness of recently proposed extensor grip test (EGT) in predicting the response to treatment. Methods: In a randomized controlled clinical trial 92 of 98 tennis elbow patients in Sina hospital of Tehran, Iran between 2006 and 2007 fulfill trial entry criteria, among these patients 56 (60.9%) had positive EGT result. Stratified on EGT result, patients allocated randomly to 5 treatment groups: Brace (B) group, physiotherapy (P), brace + physiotherapy (BP), injection (I) and injection + physiotherapy (IP). Results: Patients who had positive result of EGT had better response to treatments: less SOC (p = 0.06), less PFFQ and patients’ satisfaction scores (p < 0.001). Among the treatment IP was the most successful, then BP, P and B, respectively; injection was the worst treatment modality. Response to treatment was comparable in all groups between EGT positive and negative patients except bracing; in which positive EGT was correlated with a dramatic response to treatment. Conclusion: In all patients IP and then BP is recommended but in EGT negatives, bracing seems to be of no use. Injection alone is not recommended in either group.

Keywords: tennis elbow, extensor grip test, physiotherapy, tennis elbow treatment

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Authors: Che Jusoh, Mohd Rahimi, Toby Mundel

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This study was designed to investigate the physiological and performance effects of a local Malaysian native starch (Metroxylin sago) on cycling in a hot (30°C) and humid (78% RH) environment. Eight male, non-heat acclimated, well-trained club cyclists (VO2max 65 ± 10 ml kg-1 min-1, peak aerobic power 397 ± 71 W) completed one familiarization and three experimental trials in our laboratory simulating cycling in environmental conditions of heat and humidity. Each trial consisted of 45 minutes at a fixed workload (55% VO2max) followed by a 15 minute time-trial (~75% VO2max). Sago in porridge form was consumed 1h before exercise (Pre), in gel form during exercise (Dur) and compared to a control trial (Con), using a random, cross-over design. Plasma glucose concentration did not differ between trials (P = 0.06) with an increase from 4.1 ± 0.6 to 6.1 ± 1.6 mmol-1 (Con), 4.8 ± 1.7 to 5.7 ± 0.4 mmol-1 (Pre) and 4.7 ± 0.8 to 6.9 ± 1.4 mmol-1 (Dur) from start to end of exercise. Plasma lactate increased (P = 0.02) from 1.6 ± 0.3 to 7.6 ± 2.2 mmol-1 (Con), 1.7 ± 0.5 to 7.3 ± 2.9 mmol-1 (Pre) and 1.6 ± 0.2 to 7.3 ± 1.8 mmol-1 (Dur) with no effect of trial (P = 0.74). No differences were found between trials for RER (P = 0.328) with values of 0.93 ± 0.05 (Con), 0.94 ± 0.04 (Pre) and 0.92 ± 0.04 (Dur). There were no differences between trials in rectal (P = 0.64) and skin (P = 0.56) temperatures; values reaching 39.1 ± 0.5°C (Con), 38.9 ± 0.4°C (Pre) and 39.1 ± 0.4°C (Dur) for rectal and 32.7 ± 1.2°C (Con), 32.8 ± 1.4°C (Pre) and 32.8 ± 1.8°C (Dur) for skin temperature, respectively. Heart rate (P = 0.07) also did not differ between trials but reached maximal values by the end of time-trial for all trials. Performance was unaffected by trial (P = 0.98) with the average work completed in 15 minutes being 221 ± 33 kJ (Con), 222 ± 31 kJ (Pre) and 219 ± 32 kJ (Dur), respectively. Therefore, the results of this investigation do not support consumption of sago, either before or during exercise, in altering the thermoregulatory, metabolic or performance responses in a hot and humid environment.

Keywords: hot and humid, physiology, time trial performance, thermoregulatory

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Authors: Sedigheh Samimian, Sadra Ashrafi, Tahereh Khaleghdoost Mohammadi, Mohammad Reza Yeganeh, Ali Ashraf, Hamideh Hakimi, Maryam Dehghani

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Introduction: The recommended position for measuring Intra-Abdominal Pressure (IAP) is the supine position. However, patients put in this position are prone to Ventilator-associated pneumonia. This study was done to evaluate the relationship between bed head angle and IAP measurements of intubated patients in the intensive care unit. Methods: In this clinical trial, seventy-six critically ill patients under mechanical ventilation were enrolled. IAP measurement was performed every 8 hours for 24 hours using the KORN method in three different degrees of the head of bed (HOB) elevation (0°, 15°, and 30°). Bland-Altman analysis was performed to identify the bias and limits of agreement among the three HOBs. According to World Society of the Abdominal Compartment Syndrome (WSACS), we can consider two IAP techniques equivalent if a bias of <1 mmHg and limits of agreement of - 4 to +4 were found between them. Data were analyzed using SPSS statistical software (v. 19), and the significance level was considered as 0.05. Results: The prevalence of intra-abdominal hypertension was 18.42%. Mean ± standard deviation (SD) of IAP were 8.44 ± 4.02 mmHg for HOB angle 0°, 9.58 ± 4.52 for HOB angle 15°, and 11.10 ± 4.73 for HOB angle 30o (p = 0.0001). The IAP measurement bias between HOB angle 0◦ and HOB angle 15° was 1.13 mmHg. This bias was 2.66 mmHg between HOB angle 0° and HOB angle 30°. Conclusion: Elevation of HOB angle from 0 to 30 degree significantly increases IAP. It seems that the measurement of IAP at HOB angle 15° was more reliable than 30°.

Keywords: pressure, intra-abdominal hypertension, head of bed, critical care, compartment syndrome, supine position

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Authors: Chloe Fauchon

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In Europe, the right to a fair trial is enshrined in the European Convention on Human Rights, signed in 1950, in its famous Article 6, and, in the field of the European Union, in Article 47 of the Charter of Fundamental Rights, binding since 2009. The right to a fair trial is, therefore, a fundamental right protected by all the relevant treaties. The right to a fair trial is an "umbrella right" which encompasses various sub-rights and principles. Although this right applies in all the proceedings, it gets a special relevance in criminal matters and, particularly, regarding the defendant. In criminal proceedings, the parties are not equal: the accusation is represented by a State-organ, with specific prerogatives, and the defense does not benefit from these specific powers and is often inexperienced in criminal law. Equality of arms, and consequently the right to a fair trial, needs some specific mechanisms to be effective in criminal proceedings. For instance, the defendant benefits from some procedural rights, such as the right to a lawyer, the right to be informed of the charges against them, the right to confront witnesses, and so on. These rights aim to give the defendant the tools to dispute the accusation. The role of the defense is, therefore, very important in criminal matters to avoid unjustified convictions. This specificity of criminal matters justifies that the focus will be put on them during this study. Then this paper will also focus on French and Spanish legal orders. Indeed, if the European Court and Convention on Human Rights are the most famous instruments to protect the right to a fair trial, this right is also guaranteed at a constitutional level in European national legal orders in Europe. However, this enshrinement differs from one country to the other: for instance, in Spain, the right to a fair trial is protected explicitly by the 1978 constitutional text, whereas, in France, it is more of a case-law construction. Nevertheless, this difference between both legal orders does not imply huge variations in the substantive aspect of the right to a fair trial. This can be specifically explained by the submission of both States to the European Convention on Human Rights. This work aims to show that, although the French and Spanish legal orders differ in the way they protect the right to a fair trial, this right eventually has the same substantive meaning in both legal orders.

Keywords: right to a fair trial, constitutional law, French law, Spanish law, European Court of Human Rights

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Authors: Umair Shoukat Ali, Rashna Hoshang Sukhia, Mubassar Fida

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Introduction: The objective of the study was to compare outcomes in terms of Bleeding index (BI), Gingival Index (GI), and Orthodontic Plaque Index (OPI) with video graphics and plaque disclosing tablets (PDT) versus verbal instructions in adult orthodontic patients undergoing fixed appliance treatment (FAT). Materials and Methods: Adult orthodontic patients have recruited from outpatient orthodontic clinics who fulfilled the inclusion criteria and were randomly allocated to three groups i.e., video, PDT, and verbal groups. We included patients undergoing FAT for six months of both genders with all teeth bonded mesial to first molars having no co-morbid conditions such as rheumatic fever and diabetes mellitus. Subjects who had gingivitis as assessed by Bleeding Index (BI), Gingival Index (GI), and Orthodontic Plaque Index (OPI) were recruited. We excluded subjects having > 2 mm of clinical attachment loss, pregnant and lactating females, any history of periodontal therapy within the last six months, and any consumption of antibiotics or anti-inflammatory drugs within the last one month. Pre- and post-interventional measurements were taken at two intervals only for BI, GI, and OPI. The primary outcome of this trial was to evaluate the mean change in the BI, GI, and OPI in the three study groups. A computer-generated randomization list was used to allocate subjects to one of the three study groups using a random permuted block sampling of 6 and 9 to randomize the samples. No blinding of the investigator or the participants was performed. Results: A total of 99 subjects were assessed for eligibility, out of which 96 participants were randomized as three of the participants declined to be part of this trial. This resulted in an equal number of participants (32) that were analyzed in all three groups. The mean change in the oral hygiene indices score was assessed, and we found no statistically significant difference among the three interventional groups. Pre- and post-interventional results showed statistically significant improvement in the oral hygiene indices for the video and PDT groups. No statistically significant difference for age, gender, and education level on oral hygiene indices were found. Simple linear regression showed that the video group produced significantly higher mean OPI change as compared to other groups. No harm was observed during the trial. Conclusions: Visual aids performed better as compared to the verbal group. Gender, age, and education level had no statistically significant impact on the oral hygiene indices. Longer follow-ups will be required to see the long-term effects of these interventions. Trial Registration: NCT04386421 Funding: Aga Khan University and Hospital (URC 183022)

Keywords: oral hygiene, orthodontic treatment, adults, randomized clinical trial

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Authors: Sayeeda Laeque Bangi

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Objectives: Treating white spot lesions (WSL) to create a sound and esthetically pleasing enamel surface is a question yet to be fully answered. The objective of this randomized controlled trial was to measure and compare the degree of regression of WSL during orthodontic treatment achieved by using three commercially available materials. Methods: A single-blinded randomized prospective clinical trial, comprising 80 patients categorized into four groups (one control group and three experimental groups, with 20 subjects per group) using block randomization, was conducted. Group A (control group): Colgate strong toothpaste; and experiments groups were Group B: GC tooth mousse, Group C: Phos-Flur mouthwash and Group D: SHY-NM. Subjects were instructed to use the designated dentifrice/mouthwash and photographs were taken at baseline, third and sixth months, and white spot lesions were reassessed in the maxillomandibular anterior teeth. Results: All the three groups had shown an improvement in WSL. But Group B has shown the greatest difference in mean values of decalcification index (DI) scores. Conclusion: All three commercially available products showed a regression of WSL over a 6-month duration. GC tooth mousse proved to be the most effective means of treating WSL over other regimens.

Keywords: white spot lesions, dentifrices, orthodontic therapy, remineralization

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Authors: Muhammad Shafi'u Adamu

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This study examined the effects of two Group Cognitive Behavioural Therapies (Cognitive Restructuring and Rational Emotive Behavioural Therapy) on Psychological Distress of awaiting-trial Inmates in Correctional Centres in North-West, Nigeria. The study had four specific objectives, four research questions, and four null hypotheses. The study used a quasi-experimental design that involved pre-test and post-test. The population comprised of all 7,962 awaiting-trial inmates in correctional centres in North-west, Nigeria. 131 awaiting trial inmates from three intact Correctional Centres were randomly selected using the census technique. The respondents were sampled and randomly put into 3 groups (CR, REBT and Control). Kessler Psychological Distress Scale (K10) was adapted for data collection in the study. The instrument was validated by experts and subjected to pilot study using Cronbach's Alpha with reliability co-efficient of 0.772. Each group received treatment for 8 consecutive weeks (60 minutes/week). Data collected from the field were subjected to descriptive statistics of mean, standard deviation and mean difference to answer the research questions. Inferential statistics of ANOVA and independent sample t-test were used to test the null hypotheses at P≤ 0.05 level of significance. Results in the study revealed that there was no significant difference among the pre-treatment mean scores of experimental and control groups. Statistical evidence also showed a significant difference among the mean sores of the three groups, and thus, results of the Post Hoc multiple-comparison test indicating the posttreatment reduction of psychological distress on the awaiting-trial inmates. Documented output also showed a significant difference between the post-treatment psychologically distressed mean scores of male and female awaiting-trial inmates, but there was no difference on those exposed to REBT. The research recommends that a standardized structured CBT counselling technique treatment should be designed for correctional centres across Nigeria, and CBT counselling techniques could be used in the treatment of PD in both correctional and clinical settings.

Keywords: awaiting-trial inmates, cognitive restructuring, correctional centres, group cognitive behavioural therapies, rational emotive behavioural therapy

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Authors: Raphael Udeh, Luis García De Guadiana Romualdo, Xenia Dolje-Gore

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Background: Quite disturbing is the huge public health impact of COVID-19: As at today [25th March 2021, the COVID-19 global burden shows over 123 million cases and over 2.7 million deaths worldwide. Rationale: Recent evidence shows calprotectin’s potential as a therapeutic target, stating that tasquinimod, from the Quinoline-3-Carboxamide family is capable of blocking the interaction between calprotectin and TLR4. Hence preventing the cytokine release syndrome, that heralds the functional exhaustion in COVID-19. Early preclinical studies showed that tasquinimod inhibit tumor growth and prevent angiogenesis/cytokine storm. Phase I – III clinical studies in prostate cancer showed it has a good safety profile with good radiologic progression free survival but no effect on overall survival. Rationale/hypothesis: Strategic endeavors have been amplified globally to assess new therapeutic interventions for COVID-19 management – thus the clinical and antiviral efficacy of tasquinimod in COVID-19 remains to be explored. Hence the primary objective of this trial will be to evaluate the efficacy of tasquinimod in the treatment of adult patients with severe COVID-19 infections. Therefore, I hypothesise that among adults with COVID19 infection, tasquinimod will reduce the severe respiratory distress associated with COVID-19 compared to placebo, over a 28-day study period. Method: The setting is in Europe. Design – a randomized, placebo-controlled, phase II double-blinded trial. Trial lasts for 28 days from randomization, Tasquinimod capsule given as 0.5mg daily 1st fortnight, then 1mg daily 2nd fortnight. I0 outcome - assessed using six-point ordinal scale alongside eight 20 outcomes. 125 participants to be enrolled, data collection at baseline and subsequent data points, and safety reporting monitored via serological profile. Significance: This work could potentially establish tasquinimod as an effective and safe therapeutic agent for COVID-19 by reducing the severe respiratory distress, related time to recovery, time on oxygen/admission. It will also drive future research – as in larger multi-centre RCT.

Keywords: Calprotectin, COVID-19, Phase II Trial, Tasquinimod

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Authors: Sarinra Thongmee, Krittaporn Prakobsaeng, Adithep Mingsuan, Chanyapak Polkhet, Supattra Wongsuk

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The purposes of this research and developmentwasto develop and evaluation of the clinical nursingpractice guideline (CNPG) for the prevention infection during intubation in patient with suspected or confirmedCOVID-19 patient. This study was developed by using the evidencebased practice model of Soukup (2000) asa conceptual framework. The study consisted of 4 steps: 1) situational analysis of intubation service in patientswith confirmed COVID-19; 2) development of the CNPG; 3) apply the NPG to trial; and 4) evaluation of the CNPG. The sample consisted of 52 nurse anesthetists and 25 infected or suspected COVID-19 patients. The research instrument consisted of 1) the CNPG, which was developed by the researchers; 2) the nurses anesthetist opinion questionnaire to the guideline; 3) the evaluation practice form; and 4) the nurse anesthetist knowledge test on nursing care of patients infected with COVID-19. Data were analyzed by using descriptive statistics, and Wilcoxon matched-pairs signed rank test. The results revealed this developed CNPG consists of 4 sections: 1)the CNPG for airborne precautions2) the preparation of anesthetic and intubation equipments3) the roles and duties of the intubation team, 4) the guidelines for intubation in suspected or confirmed COVID-19 patients. The results of CNPG use found that 1)the provider: using NPG in providers revealed that nurse anesthetist had a higher mean of knowledge scores than before using CNPG statistically significant at the 0.05 level (p<0.01) and able to follow the NPG 100% inall activities. The anesthetic team was not infected with COVID-19 from intubation outside the operating room. 2)the client: the patient was safe, with no complications from intubation. Summary CNPG to prevent infection during reintubation of suspected or confirmedCOVID-19patient was appropriate and applicable to practice.

Keywords: clinical nursing practice guideline, prevention of infection, endotracheal intubation, COVID-19

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Authors: Chun-Fang Hsueh, Chen-Kang Chang

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Introduction: Branched-chain amino acids (BCAA) could reduce cerebral uptake of tryptophan, leading to decreased synthesis of serotonin in the brain. Arginine and citrulline could reduce exercise-induced hyperammonemia by increasing nitric oxide synthesis and the urea cycle. The combination of these supplements could reduce exercise-induced central fatigue. The purpose of this study was to examine the effect of BCAA, arginine, and citrulline supplementation on repeated swimming performance in teenage athletes. Methods: Eight male and eight female high school swimmers ingested 0.085 g/kg BCAA, 0.05 g/kg arginine and 0.05 g/kg citrulline (AA trial) or placebo (PL trial) in a randomized cross-over design. One hour after the ingestion, the subjects performed a 50 m sprint with their best style every 2 min for 8 times in an indoor 25 m pool. The subjects were asked to swim with their maximal effort each time. The time, stroke frequency and stroke length in each sprint were recorded. Venous blood samples were collected before and after the exercise. The time for each sprint was analyzed by 2-way analysis of variance with repeated measurement. Results: When all subjects were pooled together, total time for the AA trial was significantly faster than the PL trial (AA: 244.02 ± 22.94 s; PL: 247.55 ± 24.17 s, p < .001). Individual sprint time showed significant trial (p= .001) and trial x time (p= .004) effects. The post-hoc analysis revealed that the AA trial was significantly faster than the PL trial in the 2nd, 5th, and 6th sprint. In female subjects, there is a significant trial effect (p= .004) with the AA trial being faster in the 1st, 2nd, and 5th sprint. On the other hand, the trial effect was not significant (p= .072) in male subjects. Conclusions: The combined supplementation could improve 8 x 50 m performance in high school swimmers. The blood parameters including BCAA, tryptophan, NH₃, nitric oxide, and urea, as well as the stroke frequency and length in each sprint, are being analyzed. The results will be presented in the conference.

Keywords: central fatigue, hyperammonemia, tryptophan, urea

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Authors: Sara Ataei, Molouk Hadjibabaie, Amirhossein Moslehi, Maryam Taghizadeh-Ghehi, Asieh Ashouri, Elham Amini, Kheirollah Gholami, Alireza Hayatshahi, Mohammad Vaezi, Ardeshir Ghavamzadeh

Abstract:

Acute kidney injury (AKI) is one of the complications of hematopoietic stem cell transplantation and is associated with increased mortality. N-acetylcysteine (NAC) is a thiol compound with antioxidant and vasodilatory properties that has been investigated for the prevention of AKI in several clinical settings. In the present study, we evaluated the effects of intravenous NAC on the prevention of AKI in allogeneic hematopoietic stem cell transplantation patients. A double-blind randomized placebo-controlled trial was conducted, and 80 patients were recruited to receive 100 mg/kg/day NAC or placebo as intermittent intravenous infusion from day -6 to day +15. AKI was determined on the basis of the Risk-Injury-Failure-Loss-Endstage renal disease and AKI Network criteria as the primary outcome. We assessed urine neutrophil gelatinase-associated lipocalin (uNGAL) on days -6, -3, +3, +9, and +15 as the secondary outcome. Moreover, transplant-related outcomes and NAC adverse reactions were evaluated during the study period. Statistical analysis was performed using appropriate parametric and non-parametric methods including Kaplan–Meier for AKI and generalized estimating equation for uNGAL. At the end of the trial, data from 72 patients were analyzed (NAC: 33 patients and placebo: 39 patients). Participants of each group were not different considering baseline characteristics. AKI was observed in 18% of NAC recipients and 15% of placebo group patients, and the occurrence pattern was not significantly different (p = 0.73). Moreover, no significant difference was observed between groups for uNGAL measures (p = 0.10). Transplant-related outcomes were similar for both groups, and all patients had successful engraftment. Three patients did not tolerate NAC because of abdominal pain, shortness of breath and rash with pruritus and were dropped from the intervention group before transplantation. However, the frequency of adverse reactions was not significantly different between groups. In conclusion, our findings could not show any clinical benefits from high-dose NAC particularly for AKI prevention in allogeneic hematopoietic stem cell transplantation patients.

Keywords: acute kidney injury, N-acetylcysteine, hematopoietic stem cell transplantation, urine neutrophil gelatinase-associated lipocalin, randomized controlled trial

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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: Judge Paul Smith

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Abstract—This paper addresses the use and admissibility of psychiatric/psychological evidence in Australia Courts. There have been different approaches in the Courts to the acceptance of such expert evidence. It details how such expert evidence is admissible at trial and sentence. The methodology used is an examination of the decided cases and relevant legislative provisions which relate to the admission of such evidence. The major findings are that the evidence can be admissible if it is relevant to issues in a trial or sentence. It concludes that psychiatric/psychological evidence can be very useful and indeed may be essential at sentence or trial.

Keywords: criminal, law, psychological, evidence

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Authors: Kamal Tolani, Sandeep Kumar, Rohit Luthra, Ankit Dadhania, Krishnaprasad K., Ram Gupta, Deepa Joshi

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Background: Post-operative analgesia remains a clinical challenge, with central and peripheral sensitization playing a pivotal role in treatment-related complications and impaired quality of life. Centrally acting opioids offer poor risk benefit profile with increased intensity of gastrointestinal or central side effects and slow onset of clinical analgesia. The objective of this study was to assess the clinical feasibility of induction and maintenance therapy with Tapentadol Nasal Spray (NS) in moderate to severe acute post-operative pain. Methods: Phase III, randomized, active-controlled, non-inferiority clinical trial involving 294 cases who had undergone surgical procedures under general anesthesia or regional anesthesia. Post-surgery patients were randomized to receive either Tapentadol NS 45 mg or Tramadol 100mg IV as a bolus and subsequent 50 mg or 100 mg dose over 2-3 minutes. The frequency of administration of NS was at every 4-6 hours. At the end of 24 hrs, patients in the tramadol group who had a pain intensity score of ≥4 were switched to oral tramadol immediate release 100mg capsule until the pain intensity score reduced to <4. All patients who had achieved pain intensity ≤ 4 were shifted to a lower dose of either Tapentadol NS 22.5 mg or oral Tramadol immediate release 50mg capsule. The statistical analysis plan was envisaged as a non-inferiority trial involving comparison with Tramadol for Pain intensity difference at 60 minutes (PID60min), Sum of Pain intensity difference at 60 minutes (SPID60min), and Physician Global Assessment at 24 hrs (PGA24 hrs). Results: The per-protocol analyses involved 255 hospitalized cases undergoing surgical procedures. The median age of patients was 38.0 years. For the primary efficacy variables, Tapentadol NS was non-inferior to Inj/Oral Tramadol in relief of moderate to severe post-operative pain. On the basis of SPID60min, no clinically significant difference was observed between Tapentadol NS and Tramadol IV (1.73±2.24 vs. 1.64± 1.92, -0.09 [95% CI, -0.43, 0.60]). In the co-primary endpoint PGA24hrs, Tapentadol NS was non–inferior to Tramadol IV (2.12 ± 0.707 vs. 2.02 ±0.704, - 0.11[95% CI, -0.07, 0.28). However, on further assessment at 48hr, 72 hrs, and 120hrs, clinically superior pain relief was observed with the Tapentadol NS formulation that was statistically significant (p <0.05) at each of the time intervals. Secondary efficacy measures, including the onset of clinical analgesia and TOTPAR, showed non-inferiority to Tramadol. The safety profile and need for rescue medication were also similar in both the groups during the treatment period. The most common concomitant medications were anti-bacterial (98.3%). Conclusion: Tapentadol NS is a clinically feasible option for improved compliance as induction and maintenance therapy while offering a sustained and persistent patient response that is clinically meaningful in post-surgical settings.

Keywords: tapentadol nasal spray, acute pain, tramadol, post-operative pain

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Authors: Ashti Morovati, Hushyar Azari, Bahram Pourghassem Gargari

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Objectives and goals: The prevalence of metabolic syndrome (MetS), as a major health burden for societies, is increasing. This clinical trial was conducted to evaluate the effects of CuEO supplementation on anthropometric indices, systolic and diastolic blood pressure, blood glucose level, insulin resistance and serum lipid level in patients suffering from MetS. Methods: This was a randomized, triple‐blind, placebo‐controlled clinical trial in which 56 patients with MetS aged 18–60 years who fulfilled the eligibility criteria were randomly allocated to an intervention or a control group. Inclusion criteria for the study were comprised of diagnosis of MetS according to the new International Federation of Diabetes. The exclusion criteria were defined as: taking herbal supplements, use of drugs having evident interaction with cumin such as anti‐depressant drugs, vitamin D, omega 3, selenium, zinc, smoking, pregnancy, or breastfeeding, suffering from cancer, having any history of gastrointestinal and hepatic, cardiovascular, thyroid and kidney disorders, and menopause. 75 mg CuEO or placebo soft gels were administered three times daily to the participants for eight weeks. The soft gel consumption was checked by asking the participants to bring the medication containers in the follow‐up visits at the 4th and the 8th weeks of the study. Data pertaining to blood pressure, height, weight, waist circumference, hip circumference and BMI, as well as food consumption were collected at the beginning and end of the study. Fasting blood samples ( glucose, triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol) were obtained and biochemical measurements were assessed at the beginning and end of the study. Results: At eight weeks, a total of 44 patients completed this study. Except for diastolic blood pressure (DBP), the other assessed variables were not significantly different between the two groups. In intra group analysis, placebo and CuEO groups both had insignificant decrements in DBP (mean difference [MD] with 95% CI: −3.31 [−7.11, 0.47] and −1.77 [−5.95, 2.40] mmHg, respectively). However, DBP was significantly lower in CuEO compared with the placebo group at the end of study (81.41 ± 5.88 vs. 84.09 ± 5.54 mmHg, MD with 95% CI: −3.98 [−7.60, −0.35] mmHg, p < .05). Conclusions: The results of this study indicated that CuEO does not have any effect on MetS components, except for DBP in patients with MetS.

Keywords: blood pressure, fasting blood glucose, lipid profile, waist circumference

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Authors: Sarinra Thongmee, Adithep Mingsuan, Chanyapak Polkhet, Supattra Wongsuk, Krittaphon Prakobsaeng

Abstract:

The purposes of this research and development was to develop and evaluation of clinical nursing practice guideline (CNPG) for the prevention of infection during intubation in patient withsuspected or confirmedCOVID-19 patient. This study was developed by using the evidence based practice model of Soukup (2000) as a conceptual framework. The study consisted of 4 steps: 1) situational analysis of intubation service in patients with confirmed COVID-19, 2) development the CNPG, 3) apply the NPG to trial, and 4) evaluation of the NPG. Thesample consisted of 52 nurse anesthetists and 25 infected or suspected COVID-19 patients. The research instrument consisted of 1) CNPG, 2) the nurses anesthetist opinion questionnaire to the guideline, 3) the evaluation practice form, and 4) the nurse anesthetist knowledge test on nursing care of patients infected with COVID-19. Data were analyzed by using descriptive statistics, and Wilcoxon matched-pairs signed rank test. The results found that this developed NPG consists of 4 sections: 1) NPG for Preventing Airborne Infection Prevention2) preparation of anesthetic and intubation equipments 3) roles and duties of the intubation team 4) guidelines for intubation in suspected or confirmed COVID-19patients. The result found that 1) provider: using NPG in providers revealed that nurse anesthetist had higher mean of knowledge scores than before using NPG statistically significant at the 0.05 level (p<0.01) and able to follow the NPG 100% in all activities. The anesthetic team was not infected with COVID-19from intubation outside operating room.2) Client: the patient was safe, no complications from intubation. Summary CNPG to prevent infection in intubation of suspected or confirmedCOVID-19 patient was appropriate and applicable to practice.

Keywords: nursing practice guideline, prevention of infection, endotracheal intubation, COVID-19

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