Search results for: randomised-controlled trial

Authors: Seyed Fakhreddin Hejazi, Leili Iranirad, Mohammad Sadeghi, Mohsen Talebizadeh

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Background: Contrast-induced nephropathy (CIN) remains to be a potentially serious complication of radiographic procedures. We performed this clinical trial to assess the preventive effect of allopurinol against CIN in high-risk patients undergoing coronary angiography. Methods: In this prospective randomized controlled trial, 140 patients with at least two risk factors for CIN undergoing coronary angiography were randomly assigned to either the allopurinol group or the control group. Patients in the allopurinol group received 300 mg allopurinol 24 hours before a procedure and intravenous hydration for 12 hours before and after coronary angiography, whereas patients in the control group received intravenous hydration. Serum creatinine (SCr), blood urea nitrogen (BUN) and uric acid were measured before contrast exposure and at 48 hours. CIN was defined as an increase of 25% in serum creatinine (SCr) or >0.5 mg/dl 48 hours after contrast administration. Results: CIN occurred in 11 out of 70 (7.9%) patients in the control group and in 8 out of 70 (5.7%) patients in the allopurinol group. There was no significant difference in the incidence of CIN between the two groups at 48 hours after administering the radiocontrast agent (p = 0.459). However, there were significant differences between the two groups in SCr, BUN, uric acid, and eGFR 48 hours after radiocontrast administration (p < 0.05). Conclusion: Our findings revealed that allopurinol had no substantial efficacy over hydration protocol in high-risk patients for the development of CIN.

Keywords: contrast-induced nephropathy, allopurinol, coronary angiography, contrast agent

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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: Jiewei Li, Hongyan Cui, Chunqi Chang, Yong Hu

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It was expected to benefit patient with hemiparesis after stroke by extensive arm rehabilitation, to partially regain forearm and hand function. This paper propose a robotic rehabilitation arm in assisting the hemiparetic patient to learn new ways of using and moving their weak arms. In this study, the robotic arm was driven by a somatosensory stimulated brain computer interface (BCI), which is a new modality BCI. The use of somatosensory stimulation is not only an input for BCI, but also a electrical stimulation for treatment of hemiparesis to strengthen the arm and improve its range of motion. A trial of this robotic rehabilitation arm was performed in a stroke patient with pure motor hemiparesis. The initial trial showed a promising result from the patient with great motivation and function improvement. It suggests that robotic rehabilitation arm driven by somatosensory BCI can enhance the rehabilitation performance and progress for hemiparetic patients after stroke.

Keywords: robotic rehabilitation arm, brain computer interface (BCI), hemiparesis, stroke, somatosensory stimulation

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Authors: Mahasen M. Abdel Mageed, H. S. Zaghloul

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Annihilations, phase shifts, scattering lengths, and elastic cross sections of low energy positrons scattering from magnesium atoms were studied using the least-squares variational method (LSVM). The possibility of positron binding to the magnesium atoms is investigated. A trial wavefunction is suggested to represent e+-Mg elastic scattering and scattering parameters were derived to estimate the binding energy and annihilation rates. The trial function is taken to depend on several adjustable parameters and is improved iteratively by increasing the number of terms. The present results have the same behavior as reported semi-empirical, theoretical, and experimental results. Especially, the estimated positive scattering length supports the possibility of positron-magnesium bound state system that was confirmed in previous experimental and theoretical work.

Keywords: bound wavefunction, positron annihilation, scattering phase shift, scattering length

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Authors: Antonio Lopez-Villegas, Rafael Bautista-Mesa, Emilio Robles-Musso, Daniel Catalan-Matamoros, Cesar Leal-Costa

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Objectives: The purpose of this trial was to evaluate the burden borne by and the costs to informal caregivers of users with telemonitoring of pacemakers. Methods: This is a controlled, non-randomised clinical trial, with data collected from informal caregivers, five years after implantation of pacemakers. The Spanish version of the Survey on Disabilities, Personal Autonomy, and Dependency Situations was used to get information on clinical and social characteristics, levels of professionalism, duration and types of care, difficulties in providing care, health status, economic and job aspects, impact on the family or leisure due to informal caregiving for patients with pacemakers. Results: After five years of follow-up, 55 users with pacemakers finished the study. Of which, 50 were helped by a caregiver, 18 were included in the telemonitoring group (TM) and 32 in the conventional follow-up group (HM). Overall, females represented 96.0% of the informal caregivers (88.89% in TM and 100.0% in HM group). The mean ages were 63.17 ± 15.92 and 63.13 ± 14.56 years, respectively (p = 0.83) in the groups. The majority (88.0%) of the caregivers declared that they had to provide their services between 6 and 7 days per week (83.33% in TM group versus 90.63% in HM group), without significant differences between both groups. The costs related to care provided by the informal caregivers were 47.04% higher in the conventional follow-up group than in the TM group. Conclusions: The results of this trial confirm that there were no significant differences between the informal caregivers regarding to baseline characteristics, workload and time worked in both groups of follow-up. The costs incurred by the informal caregivers providing care for users with pacemakers included in telemonitoring group are significantly lower than those in the conventional follow-up group. Trial registration: ClinicalTrials.gov NCT02234245. Funding: The PONIENTE study, has been funded by the General Secretariat for Research, Development and Innovation, Regional Government of Andalusia (Spain), project reference number PI/0256/2017, under the research call 'Development and Innovation Projects in the Field of Biomedicine and Health Sciences', 2017.

Keywords: costs, disease burden, informal caregiving, pacemaker follow-up, remote monitoring, telemedicine

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Authors: Meryem Aydin, Serdar Karadas, Ercan Ceyhan

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The research was conducted to determine effects of salt concentrations on emergence of cowpea genotypes. Trials were performed during the year of 2014 on the laboratory of Agricultural Faculty, Selcuk University. Emergency trial was set up according to “Randomized Plots Design” by two factors and four replications with three replications. Samandag, Akkiz-86, Karnikara and Sarigobek cowpea genotypes have been used as trial material in this study. Effects of the five doses of salt concentrations (control, 30 mM, 60 mM, 90 mM and 120 mM) on the ratio of emergency, speed of emergency, average time for emergency, index of sensibility were evaluated. Responses of the cowpea genotypes for salt concentrations were found different. Comparing to the control, all of the investigated characteristics on the cowpea genotypes showed significant reduction by depending on the increasing salt application. According to the effects of salt application, the cowpea genotypes Samandag and Karnikara were the most tolerant in respect to index of sensibility while the Sarigobek genotypes was the most sensitive.

Keywords: cowpea, Vigna sinensis, emergence, salt tolerant

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Authors: Inga Žukovaitė

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This work aims to present postdoc research on remote criminal proceedings in court in order to streamline the proceedings and, at the same time, ensure the effective participation of the parties in criminal proceedings and the court's obligation to administer substantive and procedural justice. This study tests the hypothesis that remote criminal proceedings do not in themselves violate the fundamental principles of criminal procedure; however, their implementation must ensure the right of the parties to effective legal remedies and a fair trial and, only then, must address the issues of procedural economy, speed and flexibility/functionality of the application of technologies. In order to ensure that changes in the regulation of criminal proceedings are in line with fair trial standards, this research will provide answers to the questions of what conditions -first of all, legal and only then organisational- are required for remote criminal proceedings to ensure respect for the parties and enable their effective participation in public proceedings, to create conditions for quality legal defence and its accessibility, to give a correct impression to the party that they are heard and that the court is impartial and fair. It also seeks to present the results of empirical research in the courts of Lithuania that was made by using the interview method. The research will serve as a basis for developing a theoretical model for remote criminal proceedings in the EU to ensure a balance between the intention to have innovative, cost-effective, and flexible criminal proceedings and the positive obligation of the State to ensure the rights of participants in proceedings to just and fair criminal proceedings. Moreover, developments in criminal proceedings also keep changing the image of the court itself; therefore, in the paper will create preconditions for future research on the impact of remote criminal proceedings on the trust in courts. The study aims at laying down the fundamentals for theoretical models of a remote hearing in criminal proceedings and at making recommendations for the safeguarding of human rights, in particular the rights of the accused, in such proceedings. The following criteria are relevant for the remote form of criminal proceedings: the purpose of judicial instance, the legal position of participants in proceedings, their vulnerability, and the nature of required legal protection. The content of the study consists of: 1. Identification of the factual and legal prerequisites for a decision to organise the entire criminal proceedings by remote means or to carry out one or several procedural actions by remote means 2. After analysing the legal regulation and practice concerning the application of the elements of remote criminal proceedings, distinguish the main legal safeguards for protection of the rights of the accused to ensure: (a) the right of effective participation in a court hearing; (b) the right of confidential consultation with the defence counsel; (c) the right of participation in the examination of evidence, in particular material evidence, as well as the right to question witnesses; and (d) the right to a public trial.

Keywords: remote criminal proceedings, fair trial, right to defence, technology progress

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Authors: M. Yasin Al-Arif, Mohammad Faisol Soleh

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The Indonesia’s Constitution in Article 18b explained that the state recognizes and respects indigenous peoples and their traditional rights that are guaranteed by the law. Despite already guaranteed its existence; in practice such indigenous law is often considered contrary to positive law by legal experts. It is because of legal positivism paradigm which requires the written law as the main reference for the settlement of legal disputes. Carok’s culture is one of the indigenous cultures of Madura to resolve legal disputes that still thrives until today. Carok’s culture is in outside the legal process, and through a fight between the disputing parties until one dies. On the other hand, the legal positivism does not give place to accommodate Carok as indigenous dispute settlement, until it must be solved through trial. This way of settlement has not been successfully satisfying the indigenous people, thus although it has been done through its verdict in the trial, but Carok still be used by them. From the explanation above, Carok’s culture must be accommodated as the main settlement process and legal process of law as the alternative to the effectiveness of dispute resolution in Madura Indonesia.

Keywords: carok, dispute settlement, legal positivism, madura’s culture

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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: Paria Baharvand, Mohammad Reza Abbasi, Soha Namazi

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Introduction: Uremic pruritus (UP) is one of the major complaints in hemodialysis patients. The aim of this randomized clinical trial study was the evaluation of the anti-pruritus effect of Melatonin on hemodialysis patients with UP. Methods: This multi-centered double, blinded randomized clinical trial study was conducted on hemodialysis patients with UP that referred to the dialysis department of Imam Khomeini Hospital, Labbafinezhad Hospital and Ghiasi Hospital in Tehran, Iran, in 2018. Forty participants were enrolled and block randomization was performed by using a randomized list and divided into 2 groups of twenty patients. Evaluation of the 12-Item Pruritus Severity Scale (12-PSS), Visual analog scale (VAS), and Calculation of the affected body surface area for pruritus extent (BSA %) was performed every week. The Melatonin group received a 10 mg soft gel capsule, and the placebo group received a soft gel capsule placebo after dinner. For statistical analysis used by SPSS version 21(IRCT20180714040462N1). Results: 38 hemodialysis patients enrolled in this study. The mean age in the placebo group and in the Melatonin group was 55.88 ± 11.70 and 54.52 ± 13.00 years (p> 0.05). Also, 46% of all participants were female. Aspartate transaminase, alanine transaminase and C-reactive protein have significant differences between the two groups (p< 0.05). VAS score reduction in the two groups had a statistically significant (CI 95% = -1.71, P= 0.015(.The results of BSA% showed Melatonin had a significant effect on the decrease of the pruritus extent compared to placebo (CI 95% = -22.82, P= 0.001(. Conclusion: According to the results of this study and the preliminary effects of Melatonin on uremic pruritus, we suggest performing advanced clinical trials studies.

Keywords: Melatonin, Uremic Pruritus, hemodialysis, anti-pruritus

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Authors: D. Garg, S. Luthra, A. Haleem

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Reverse logistics (RL) is supposed to be a systematic procedure that helps in improving the environmental hazards and maintain business sustainability for industries. Industries in Indian are now opting for adoption of RL techniques in business. But, RL practices are not popular in Indian industries because of many barriers for its successful implementation. Therefore, need arises to identify and evaluate the barriers to implement RL practices by taking an Indian industries perspective. Literature review approach and case study approach have been adapted to identify relevant barriers to implement RL practices. Further, Fuzzy Decision Making Trial and Evaluation Laboratory methodology has been brought into use for evaluating causal relationships among the barriers to implement RL practices. Seven barriers out of ten barriers have been categorized into the cause group and remaining into effect group. This research will help Indian industries to manage these barriers towards effective implementing RL practices.

Keywords: barriers, decision making trial and evaluation laboratory (DEMATEL), fuzzy set theory, Indian industries, reverse logistics (RL)

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Authors: Mostafa Solati

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Objectives: Considering the gap of information regarding the optimal antimicrobial efficacy of metronidazole for application in the implant screw hole, this study aimed to compare the antimicrobial efficacy of 0.75% metronidazole and 2% chlorhexidine (CHX) gel applied in the implant screw hole. Materials and Methods: This randomized controlled clinical trial evaluated 60 implants (20 patients, each requiring three implants) in three groups (n=20). In group 1, 0.75% metronidazole gel was applied to the implant screw hole. In group 2, 2% CHX gel was applied, and in group 3, no material was used. Microbial samples were collected from the screw holes after three months, and the microbial colonies were counted. Data were analyzed using ANOVA. Results: The number of bacteria in the control group was significantly higher than that in 0.75% metronidazole gel and 2% CHX groups (P<0.05). The CHX group caused the maximum reduction in colony count with no significant difference from the metronidazole group (P>0.05). Conclusion: The application of 0.75% metronidazole gel and 2% CHX can effectively decrease the colony count in the implant screw hole and can probably play a role in the preservation of peri-implant tissue health.

Keywords: dental implant, metronidazole, CHX, screw hole

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Authors: U. Umadevi, T. Umakanthan

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Globally, mycotic dermatitis is very common but there is no single proven specific allopathic treatment regimen. In this study, domestic animals with skin diseases of different age and breed from geographically varied regions of Tamil Nadu state, India were employed. Most of them have had previous treatment with native and allopathic medicines without success. Clinically, the skin lesions were found to be mild to severe. The trial animals were treated with poly herbal formulation (ointment) prepared using the indigenous medicinal plants – viz Andrographis paniculata, Lawsonia inermis and Madhuca longifolia. Allopathic antifungal drugs and ointments, povidone iodine and curabless (Terbinafine HCl, Ofloxacin, Ornidazole, Clobetasol propionate) were used in control. Comparatively, trial animals were found to have lesser course of treatment time and higher recovery rate than control. In Ethnoveterinary, this combination was tried for the first time. This herbal formulation is economical and an alternative for skin diseases.

Keywords: allopathic drugs, dermatitis, domestic animals, poly herbal formulation

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Authors: Neda Jamalimoghadam, Naval Heydari, Maliheh Abootalebi, Maryam Kasraeian, M. Emamghoreishi , Akbarzadeh Marzieh

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Background: The aim was to investigate the effect of aromatherapy using Citrus aurantium blossom essential oil on premenstrual syndrome in university students. Methods: In this double-blind clinical trial was controlled on 62 students from March 2016 to February 2017. The intervention with 0.5% of C. Aurantium blossom essential oil and control was inhalation of odorless sweet almond oil in the luteal phase of the menstrual cycle. The screening questionnaire (PSST) for PMSwas filled out before and also one and two months after the intervention. Results: Mean score of overall symptoms of PMS between the Bitter orange and control groups In the first (p < 0.003) and second months (p < 0.001) of the intervention was significant. Besides, decreased the mean score of psychological symptoms in the intervention group (p < 0.001), but on physical symptoms and social function were not significant (p > 0.05). Conclusion: The aromatherapy with Citrus aurantium blossom improved the symptoms of premenstrual syndrome.

Keywords: aromatherapy, Citrus Aurantium, premenstrual syndrome, oil, students

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Authors: Alejandro Rodríguez-Molinero, Carlos Pérez-López, Jorge Hernández-Vara, Àngels Bayes-Rusiñol, Juan Carlos Martínez-Castrillo, David A. Pérez-Martínez

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Background: Monitoring motor symptoms in Parkinson's patients is often a complex and time-consuming task for clinicians, as Hauser's diaries are often poorly completed by patients. Recently, new automatic devices (Parkinson's holter: STAT-ON®) have been developed capable of monitoring patients' motor fluctuations. The MoMoPa-EC clinical trial (NCT04176302) investigates which of the two methods produces better clinical results. In this sub-analysis, the concordance between both methods is analyzed. Methods: In the MoMoPa-EC clinical trial, 164 patients with moderate-severe Parkinson's disease and at least two hours a day of Off will be included. At the time of patient recruitment, all of them completed a seven-day motor fluctuation diary at home (Hauser’s diary) while wearing the Parkinson's holter. In this sub-analysis, 71 patients with complete data for the purpose of this comparison were included. The intraclass correlation coefficient was calculated between the patient diary entries and the Parkinson's holter data in terms of time On, Off, and time with dyskinesias. Results: The intra-class correlation coefficient of both methods was 0.57 (95% CI: 0.3-0.74) for daily time in Off (%), 0.48 (95% CI: 0.14-0.68) for daily time in On (%), and 0.37 (95% CI %: -0.04-0.62) for daily time with dyskinesias (%). Conclusions: Both methods have a moderate agreement with each other. We will have to wait for the results of the MoMoPa-EC project to estimate which of them has the greatest clinical benefits. Acknowledgment: This work is supported by AbbVie S.L.U, the Instituto de Salud Carlos III [DTS17/00195], and the European Fund for Regional Development, 'A way to make Europe'.

Keywords: Parkinson, sensor, motor fluctuations, dyskinesia

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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: Anum Akhter, Sumaira Altaf

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Purpose: To study the effect of low vision devices i.e. telescope and magnifying glasses on distance visual acuity and near visual acuity of children with Stargardt’s disease. Setting: Low vision department, Alshifa Trust Eye Hospital, Rawalpindi, Pakistan. Methods: 52 children having Stargardt’s disease were included in the study. All children were diagnosed by pediatrics ophthalmologists. Comprehensive low vision assessment was done by me in Low vision clinic. Visual acuity was measured using ETDRS chart. Refraction and other supplementary tests were performed. Children with Stargardt’s disease were provided with different telescopes and magnifying glasses for improving far vision and near vision. Results: Out of 52 children, 17 children were males and 35 children were females. Distance visual acuity and near visual acuity improved significantly with low vision aid trial. All children showed visual acuity better than 6/19 with a telescope of higher magnification. Improvement in near visual acuity was also significant with magnifying glasses trial. Conclusions: Low vision aids are useful for improvement in visual acuity in children. Children with Stargardt’s disease who are having a problem in education and daily life activities can get help from low vision aids.

Keywords: Stargardt, s disease, low vision aids, telescope, magnifiers

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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

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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: Arslan Shehroz, Muhammad Amjad Ali, Amjad Abbas, Imran Ramzan, Muhammad Zunair Latif

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Potato (Solanum tuberosum L.) is the 4th most important food crop of the world after wheat, rice and maize. It is the staple food in many European countries. Being rich in starch (one of the main three food ingredients) and having the highest productivity per unit area, has great potential to address the challenge of the food security. Processed potato is also used as chips and crisps etc as ‘fast food’. There are many biotic and abiotic factors which check the production of potato and become hurdle in achievement production potential of potato. 20 new varieties along with two checks were evaluated. Plant to plant and row to row distances were maintained as 20 cm and 75 cm, respectively. The trial was conducted according to the randomized complete block design with three replications. Normal agronomic and plant protection measures were carried out in the crop. It is revealed from the experiment that exotic variety 171 gave the highest yield of 35.5 t/ha followed by Masai with 31.0 t/ha tuber yield. The check variety Simply Red 24.2 t/ha yield, while the lowest tuber yield (1.5 t/ha) was produced by the exotic variety KWS-06-125. The maximum emergence was shown by the Variety Red Sun (89.7 %). The lowest emergence was shown by the variety Camel (71.7%). Regarding tuber grades, it was noted that the maximum Ration size tubers were produced by the exotic variety Compass (3.7%), whereas 11 varieties did not produce ration size tubers at all. The variety Red Sun produced lowest percentage of small size tubers (12.7%) whereas maximum small size tubers (93.0%) were produced by the variety Jitka. Regarding disease infestation, it was noted that the maximum scab incidence (4.0%) was recorded on the variety Masai, maximum rhizoctonia attack (60.0%) was recorded on the variety Camel and maximum tuber cracking (0.7%) was noted on the variety Vendulla.

Keywords: check variety, potato, potential and yield, trial

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Authors: Woogul Lee, Johnmarshall Reeve

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Learners’ perceived autonomy predicts learners’ interest, engagement, and learning. To understand these processes, we conducted an fMRI experiment. In this experiment, participants saw the national flag and were asked to rate how much they freely wanted to learn about that particular national flag. The participants then learned the characteristics of the national flag. Results showed that (1) the degree of participants’ perceived autonomy was positively correlated with the degree of insula activity, (2) participants’ early-trial insula activity predicted corresponding late-trial dorsolateral prefrontal cortex activity, and (3) the degree of dorsolateral prefrontal cortex activity was positively correlated with the degree of participants’ learning about the characteristics of the national flag. Results suggest that learners’ perceived autonomy predicts learning through the mediation of insula activity associated with intrinsic satisfaction and 'pure self' processes.

Keywords: insular cortex, autonomy, self-determination, dorsolateral prefrontal cortex

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Authors: Maryam Shayani Rad, Seyed Ahmad Mohajeri, Mohsen Mouhebati, Seyed Danial Mousavi

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High blood pressure is one of the most important and serious health-threatening because of no symptoms in most people, which can lead to sudden heart attack, heart failure, and stroke. Nowadays, herbal medicine is one of the best and safest strategies for treatment that have no adverse effects. Apium graveolens (celery) can be used as an alternative treatment for many health conditions such as hypertension. Natural compounds reduce blood pressure via different mechanisms in which Apium graveolens extract provides potent calcium channel blocking properties. A randomized, double-blind, placebo-controlled, cross-over clinical trial was done to evaluate the efficacy of formulated Apium graveolens extract with a maximum yield of 3-n-butylphthalide to reduce systolic and diastolic blood pressure in patients with hypertension. 54 hypertensive patients in the range of 20-68 years old were randomly assigned to the treatment group (26 cases) and the placebo control group (26 cases) and were crossed over after washout duration. The treatment group received at least 2 grams of formulated powder in hard capsules orally, before each meal, 2 times daily. The control group received 2 grams of placebo in hard capsules orally, exactly as the same as shape, time, and doses of treatment group. Treatment was administrated in 12 weeks with 4 weeks washout period at the middle of the study, meaning 4 weeks drug consumption for the treatment group, 4 weeks washout and 4 weeks placebo consumption, and vice versa for the placebo control group. The clinical assessment was done 4 times, including at the beginning and ending of the drug and placebo consumption period by 24-hour ambulatory blood pressure monitoring (ABPM) holter, which measured blood pressure every 15 minutes continuously. There was a statistically significant decrease in both systolic blood pressure (SBP) and diastolic blood pressure (DBP) at the end of drug duration compared to baseline. The changes after 4 weeks on average was about 12.34 mm Hg for the SBP (P < 0.005) and 7.83 mm Hg for the DBP (P < 0.005). The results from this clinical trial study showed this Apium graveolens extract formulation in the mentioned dosage had a significant effect on blood pressure-lowering for hypertensive patients.

Keywords: Apium graveolens extract, clinical trial, cross-over, hypertension

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Authors: Akinwumi Omotayo, Badu-B Apraku, Joseph Olobasola, Petra Abdul Saghir, Yinka Sobowale

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In southwestern Nigeria, climate change has led to loss of at least two months of rainfall. Consequently, only one cycle of maize can now be grown because of the shorter duration of rainy season as against two cycles in the past. The Early and Extra-early maturing varieties of maize were originally developed for the semi-arid and arid zones of West and Central Africa where there are seasonal challenges of water threatening optimum performance of the traditional maize grown, which are commonly late in maturity (115 to 120 days). The early varieties of maize mature in 90 to 95 days; while the Extra-Early maize varieties reach physiological maturity in less than 90 days. It was broadly hypothesized that the extra early varieties of maize could mitigate the effects of climate change in southwestern Nigeria with higher levels of rainfall by reinstating the original two cycles of rain-fed maize crop. Trials were therefore carried out in southwestern Nigeria on the possibility of adapting the extra early maize to mitigate the effects of climate change. The trial was the Mother/Baby design. The mother trial involves the evaluation of extra-early varieties following ideal recommendations and closely supervised centrally at the University research farm and the Agricultural Development Programmes (ADPs). This requires farmers to observe and evaluate the technology and the management regime meant to precede the second stage of evaluation at several satellite farmers field managed by selected farmers. The Baby Trial is expected to provide a realistic assessment of the technology by farmers in their own environment. A stratified selection of thirty farmers for the Baby Trial ensured appropriate representation across the different categories of the farming population by age and gender. Data from the trials indicate that extra early maize can be grown in two cycles rain fed in south west Nigeria and a third and fourth cycle could be obtained with irrigation. However the long duration varieties outyielded the extra early maize in both the mother and baby trials. When harvested green, the extra early maize served as source of food between March and May when there was scarcity of food. This represents a major advantage. The study recommends that further work needs to be done to improve the yield of extra early maize to encourage farmers to adopt.

Keywords: adaptation, climate change, extra early, maize varieties, mitigation

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Authors: Muthukuda Arachchige Dona Shiroma Jeeva Shirajanie Niriella

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The necessity of protection of the rights of victims of crime is a matter of concerns today. In the criminal justice system, child victims who are subjected to sexual abuse/violence are more vulnerable than the other crime victims. When they go to the police to lodge the complaint and until the end of the court proceedings, these victims are re-victimized in the criminal justice system. The rights of the suspects, accused and convicts are recognized and guaranteed by the constitution under fair trial norm, contemporary penal laws where crime is viewed as an offence against the State and existing criminal justice system in many jurisdictions including Sri Lanka. In this backdrop, a reasonable question arises as to whether the existing criminal justice system, especially which follow the adversarial mode of judicial trial protect the fair trial norm in the criminal justice process. Therefore, this paper intends to discuss the rights of the sexually abused child victims in the criminal justice system in order to restore imbalance between the rights of the wrongdoer and victim and suggest legal reforms to strengthen their rights in the criminal justice system which is essential to end secondary victimization. The paper considers Sri Lanka as a sample to discuss this issue. The paper looks at how the child victims are marginalized in the traditional adversarial model of the justice process, whether the contemporary penal laws adequately protect the right of these victims and whether the current laws set out the provisions to provide sufficient assistance and protection to them. The study further deals with the important principles adopted in international human rights law relating to the protection of the rights of the child victims in sexual offences cases. In this research paper, rights of the child victims in the investigation, trial and post-trial stages in the criminal justice process will be assessed. This research contains an extensive scrutiny of relevant international standards and local statutory provisions. Case law, books, journal articles, government publications such as commissions’ reports under this topic are rigorously reviewed as secondary resources. Further, randomly selected 25 child victims of sexual offences from the decided cases in last two years, police officers from 5 police divisions where the highest numbers of sexual offences were reported in last two years and the judicial officers both Magistrates and High Court Judges from the same judicial zones are interviewed. These data will be analyzed in order to find out the reasons for this specific sexual victimization, needs of these victims in various stages of the criminal justice system, relationship between victimization and offending and the difficulties and problems that these victims come across in criminal justice system. The author argues that the child victims are considerably neglected and their rights are not adequately protected in the adversarial model of the criminal justice process.

Keywords: child victims of sexual violence, criminal justice system, international standards, rights of child victims, Sri Lanka

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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: Wenru Wang

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Over the past decades, Asia has emerged as the ‘diabetes epicentre’ in the world due to rapid economic development, urbanization and nutrition transition. There is an urgent need to develop more effective and cost-effective care management strategies in response to this rising diabetes epidemic. This study aims to develop and compare a nurse-led smartphone-based self-management programme with an existing nurse-led diabetes service on health-related outcomes among type 2 diabetes patients with poor glycemic control in Singapore. We proposed a randomized controlled trial with pre- and repeated post-tests control group design. A total of 128 type 2 diabetes patients with poor glycemic control will be recruited from the diabetes clinic of an acute public hospital in Singapore through convenience sampling. Study participants will be either randomly allocated to the experimental group or control group. Outcome measures used will include the 10-item General Self-Efficacy Scale, 11-item Revised Summary of Diabetes Self-care Activities, and 19-item Diabetes-Dependent Quality of Life. Data will be collected at 3-time points: baseline, three months and six months from the baseline, respectively. It is expected that this programme will be an alternative offered to diabetes patients to master their self-care management skills, in addition to the existing diabetes service provided in diabetes clinics in Singapore hospitals. Also, the self-supporting and less resource-intensive nature of this programme, through the use of smartphone app as a mode of intervention delivery, will greatly reduce nurses’ direct contact time with patients and allow more time to be allocated to those who require more attention. The study has been registered with clinicaltrials.gov. The trial registration number is NCT03088475.

Keywords: type 2 diabetes, poor glycaemic control, nurse-led, smartphone-based, self-management, health-relevant outcomes

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Authors: Kim H. K. Choy, Oliva H. K. Chu, W. Y. Keung, B. Lim, Winnie P. Y. Tang

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Background: The prevalence of workplace obesity is rising worldwide; therefore, the workplace is an ideal venue to implement weight control intervention. This pilot randomized controlled trial aimed to develop, implement, and evaluate a nutritional wellness program for obese health care providers working in a hospital. Methods: This hospital-based nutritional wellness program was an 8-week pilot randomized controlled trial for obese health care providers. The primary outcomes were body weight and body mass index (BMI). The secondary outcomes were serum fasting glucose, fasting cholesterol, triglyceride, high-density (HDL) and low-density (LDL) lipoprotein, body fat percentage, and body mass. Participants were randomly assigned to the intervention (n = 20) or control (n = 22) group. Participants in both groups received individual nutrition counselling and nutrition pamphlets, whereas only participants in the intervention group were given mobile phone text messages. Results: 42 participants completed the study. In comparison with the control group, the intervention group showed approximately 0.98 kg weight reduction after two months. Participants in intervention group also demonstrated clinically significant improvement in BMI, serum cholesterol level, and HDL level. There was no improvement of body fat percentage and body mass for both intervention and control groups. Conclusion: The nutritional wellness program for obese health care providers was feasible in hospital settings. Health care providers demonstrated short-term weight loss, decrease in serum fasting cholesterol level, and HDL level after completing the program.

Keywords: weight management, weight control, health care providers, hospital

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Authors: Romina Beqiri

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In the context of the prosecution of those responsible for the commission of the most hideous crimes and the fight against impunity, a fundamental role is played by witnesses of the crimes who contribute to ascertaining the ‘procedural truth’. This article examines recent decisions and legislation of the Hague-based International Criminal Court in terms of the endangerment of the integrity of the criminal proceedings in consequence of witness tampering. The analysis focuses on the new developments in the courtroom and the academia, in particular, on the first-ever sentence confirming the charges of corruptly influencing witnesses, interpretation of presenting false evidence and giving false testimony when under an obligation to tell the truth. Confronted with recent tampering with witnesses and their credibility at stake in the ongoing cases, the research explores different Court’s decisions and scholars’ legal disputes concerning the deterrence approach to punish the authors of offences against the administration of justice when committed intentionally. Therefore, the analysis concludes that the Court cannot tolerate any witness false testimony and should enhance consistency and severity of sanctions for the sake of fair trial and end impunity.

Keywords: International Criminal Court, administration of justice, credibility of witness, fair trial, false testimony, witness tampering

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Authors: Maryam Rafraf, Aida Ghaffari

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Objectives: Nonalcoholic fatty liver disease (NAFLD) is considered as an independent risk factor for cardiovascular disease (CVD). Dyslipidemia contributes to the enhanced risk of CVD in persons with NAFLD. This study aimed to investigate the effects of turmeric supplementation on serum lipids levels in patients with NAFLD. Methods: In this double-blind, randomized, controlled clinical trial, 46 NAFLD patients (21 males and 25 females; age range, 20 – 60 years) were randomly assigned in the two groups. The intervention and control groups received 3g of turmeric (n = 23) and placebo (n = 23), daily for 12 weeks. Fasting blood samples were collected at baseline and at the end of the trial. Results: Turmeric supplementation significantly increased serum levels of HDL-C compared with the placebo group at the end of the study (by 12.73%, P < 0.05). Serum levels of triglyceride, total cholesterol, and low-density lipoprotein cholesterol were significantly reduced within turmeric group at the end of the study (P < 0.05). Conclusions: Turmeric consumption had beneficial effects on serum lipids levels of subjects and may be useful in controlling of CVD risk factors in NAFLD patients.

Keywords: nonalcoholic fatty liver, serum lipids, supplementation, turmeric

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

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

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

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Authors: Kunihisa Kakumoto

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“Purpose”: Global environmental issues are now being raised in a global dimension. By predicting sprawl phenomena beyond the limits of nature with algorithms, we can expect to protect our social life within the limits of nature. It turns out that the sustainable state of the planet now consists in maintaining a balance between the capabilities of nature and the possibilities of our social life. The amount of water on earth is finite. Sustainability is therefore highly dependent on water capacity. A certain amount of water is stored in the forest by planting and green space, and the amount of water can be considered in relation to the green space. CO2 is also absorbed by green plants. "Possible measurements and methods": The concept of the solar community has been introduced in technical papers on the occasion of many international conferences. The solar community concept is based on data collected from one solar model house. This algorithmic study simulates the amount of water stored by lush green vegetation. In addition, we calculated and compared the amount of CO2 emissions from the Taiyo Community and the amount of CO2 reduction from greening. Based on the trial calculation results of these solar communities, we are simulating the sustainable state of the earth as an algorithm trial calculation result. We believe that we should also consider the composition of this solar community group using digital technology as control technology. "Conclusion": We consider the solar community as a prototype for finding sustainable conditions for the planet. The role of water is very important as the supply capacity of water is limited. However, the circulation of social life is not constructed according to the mechanism of nature. This simulation trial calculation is explained using the total water supply volume as an example. According to this process, algorithmic calculations consider the total capacity of the water supply and the population and habitable numbers of the area. Green vegetated land is very important to keep enough water. Green vegetation is also very important to maintain CO2 balance. A simulation trial calculation is possible from the relationship between the CO2 emissions of the solar community and the amount of CO2 reduction due to greening. In order to find this total balance and sustainable conditions, the algorithmic simulation calculation takes into account lush vegetation and total water supply. Research to find sustainable conditions is done by simulating an algorithmic model of the solar community as a prototype. In this one prototype example, it's balanced. The activities of our social life must take place within the permissive limits of natural mechanisms. Of course, we aim for a more ideal balance by utilizing auxiliary digital control technology such as AI.

Keywords: solar community, sustainability, prototype, algorithmic simulation

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