Tolerability Issues Research Articles

Abstract WMP37: Differential Montage Effect On Cortical Excitability In Ischemic Stroke Patients By Single Session Of High Amperage Transcranial Direct Current Stimulation

Background and Objective: We aim to assess the cortical excitability under three montages with single session of transcranial direct current stimulation (tDCS) at 4 mA on ischemic stroke patients. Methods: Adult subjects with first-ever unilateral ischemic stroke ≥6 months and inducible motor evoked potentials (MEP) underwent 3 sessions (washed out ≥2 days apart) of 30 minutes 4 mA tDCS in anodal, cathodal or bihemispheric montage (in pseudorandom order) combined with t upper extremity repetitive task training administered by an Occupational Therapist. We collected MEP responses to transcranial magnetic stimulation (TMS) single pulse, short intracortical inhibition (SICI, 3 ms) and intracortical facilitation (ICF, 15 ms) on bilateral abductor pollicis brevis (APB) muscles at baseline and four post-stimulation timepoints 12 minutes apart. We also monitored safety by recording adverse events, surveying subjects with a questionnaire on tolerability issues and collecting biometric measures (body resistance, skin temperature under the tDCS electrode). Results: Eighteen subjects completed 54 tDCS sessions in total. We observed montage ( P <0.0001) and time ( P <0.01) effects only on the lesioned hemisphere, with bihemispheric tDCS showing relatively higher peak-to-peak MEP. Lack of montage effect in baseline ( P >0.949) suggested sufficient washout interval across the visits. No subjects experienced any adverse events. Biometric measures and tolerability were comparable across the three montages. The most common tolerability issue was transient redness under the tDCS electrodes (70% at anode, 48% at cathode). Conclusions: The bihemispheric montage increased ipsilateral cortical excitability the most in a single session of 4 mA tDCS in chronic ischemic stroke patients. Additionally, a current level of 4 mA is safe and tolerable over multiple sessions.

Effectiveness and tolerability of perampanel in сhildren and adolescents (own experience of Svt. Luka’s Institute of Child Neurology and Epilepsy)

Effectiveness and tolerability of perampanel in сhildren and adolescents (own experience of Svt. Luka’s Institute of Child Neurology and Epilepsy)

Secukinumab for the treatment of palmoplantar psoriasis: a 2-year, multicenter, real-life observational study

ABSTRACT Background Palmoplantar psoriasis is difficult to treat and often recalcitrant to conventional therapies. Clinical trials have demonstrated the efficacy and safety of secukinumab for this debilitating psoriasis form, but real-life evidence is currently limited. Therefore, here we described the outcomes of patients treated with secukinumab in clinical practice. Research Design and Methods This was a real-life, retrospective, observational study involving patients with palmoplantar psoriasis treated with secukinumab (300 mg, subcutaneously) at seven dermatologic clinics in Italy. Treatment effectiveness was evaluated based on the changes of the Psoriasis Area and Severity Index (PASI) and palmoplantar (pp) PASI during treatment and by recording safety and tolerability issues over 104 weeks. Results Forty-three patients initiated treatment with secukinumab. Previous treatments included topical and systemic therapies; half of patients had already tried one or more biologics. Secukinumab improved mean PASI rapidly and substantially with a 78.2% decrease at 16 weeks. Mean ppPASI also improved substantially, but more gradually, with reductions of 55.0% and 79.3% at 16 and 104 weeks, respectively. Approximately half of patients achieved complete skin clearance at 40 weeks. Secukinumab was well tolerated and no relevant treatment-related adverse events were reported. Conclusions Secukinumab appears to be effective for the treatment of palmoplantar psoriasis also in the real-life setting.

Evaluating sacubitril/valsartan as a treatment option for heart failure with reduced ejection fraction and preserved ejection fraction

ABSTRACT Introduction Sacubitril/valsartan is the first-in-class angiotensin-receptor neprilysin inhibitor approved in 2015 for the treatment of heart failure with reduced ejection fraction (HFrEF). On 16 February 2021, the Food and Drug Administration acknowledged that “Benefits are most clearly evident in patients with left ventricular ejection fraction below normal,” thus potentially extending the use in subjects with heart failure and preserved ejection fraction (HFpEF). Areas covered The authors outline the regulatory history, pharmacokinetics, pharmacodynamics, and risk-benefit profile of sacubitril/valsartan in HFrEF and HFpEF. A critical cross-trial comparison is presented, including sodium-glucose cotransporter 2 inhibitors (SGLT2i), together with an insight into the latest European Society of Cardiology guidelines, where the new category of heart failure with mildly reduced ejection fraction is introduced. Expert opinion Sacubitril/valsartan is a foundation of the pharmacological armamentarium in HFrEF to counteract the neuro-hormonal changes and reverse cardiac remodeling, together with beta-blockers, SGLT2i and mineralocorticoid receptor antagonists. The optimal sequence algorithm is an evolving issue, and the authors provide the reader with their personal perspective. A multidisciplinary management is encouraged to minimize the therapeutic inertia and manage tolerability issues, thus supporting adherence. Pragmatic trials, pharmacovigilance, and high-quality real-world evidence are crucial toward personalized safe prescribing of sacubitril/valsartan.

Migraine.

Migraine is a common, chronic, disorder that is typically characterized by recurrent disabling attacks of headache and accompanying symptoms, including aura. The aetiology is multifactorial with rare monogenic variants. Depression, epilepsy, stroke and myocardial infarction are comorbid diseases. Spreading depolarization probably causes aura and possibly also triggers trigeminal sensory activation, the underlying mechanism for the headache. Despite earlier beliefs, vasodilation is only a secondary phenomenon and vasoconstriction is not essential for antimigraine efficacy. Management includes analgesics or NSAIDs for mild attacks, and, for moderate or severe attacks, triptans or 5HT1B/1D receptor agonists. Because of cardiovascular safety concerns, unreliable efficacy and tolerability issues, use of ergots to abort attacks has nearly vanished in most countries. CGRP receptor antagonists (gepants) and lasmiditan, a selective 5HT1F receptor agonist, have emerged as effective acute treatments. Intramuscular onabotulinumtoxinA may be helpful in chronic migraine (migraine on ≥15 days per month) and monoclonal antibodies targeting CGRP or its receptor, as well as two gepants, have proven effective and well tolerated for the preventive treatment of migraine. Several neuromodulation modalities have been approved for acute and/or preventive migraine treatment. The emergence of new treatment targets and therapies illustrates the bright future for migraine management.

Fat-rich versus carbohydrate-rich nutrition in ALS: a randomised controlled study

ObjectiveThere is growing evidence that the course of amyotrophic lateral sclerosis (ALS) may be influenced beneficially by applying high-caloric food supplements (HCSs). However, it is unknown which composition of nutrients...

Building Compassion and Human Bridges through Research Collaborations.

Our ENLACE binational summer research program was established with the aim of encouraging the participation of high school and college students in research in the sciences and engineering, while promoting cross-border friendships between the United States and Mexico. The program unites students around science and engineering questions and concurrently engages them in a rich curriculum that promotes understanding of broader societal issues of equity, inclusion, tolerance, and social justice. Because we built our program around hope and cooperation, it is our aspiration and promise that walls and borders—all kinds of walls and borders—can be eradicated through kindness, compassion, and respect for others. ENLACE is not just a program we organize every summer, it is also a program that defines who we are as people and the kind of contribution we want to make in the world.

B. infantis EVC001 Is Well-Tolerated and Improves Human Milk Oligosaccharide Utilization in Preterm Infants in the Neonatal Intensive Care Unit.

Not all infants carry specialized gut microbes, meaning they cannot digest human milk oligosaccharides and therefore do not receive complete benefits from human milk. B. infantis EVC001 is equipped to convert the full array of complex oligosaccharides into compounds usable by the infant, making it an ideal candidate to stabilize gut function and improve nutrition in preterm infants. A prospective, open-label study design was used to evaluate the tolerability of B. infantis EVC001 and its effects on the fecal microbiota in preterm infants in a Neonatal Intensive Care Unit. Thirty preterm infants <1,500 g and/or <33 weeks gestation at birth were divided into two matched groups, and control infants were enrolled and discharged prior to enrolling EVC001 infants to prevent cross-colonization of B. infantis: (1) fifteen control infants received no EVC001, and (2) fifteen infants received once-daily feedings of B. infantis EVC001 (8.0 x 109 CFU) in MCT oil. Clinical information regarding medications, growth, nutrition, gastrointestinal events, diagnoses, and procedures was collected throughout admission. Infant stool samples were collected at baseline, Study Days 14 and 28, and 34-, 36-, and 38-weeks of gestation. Taxonomic composition of the fecal microbiota, functional microbiota analysis, B. infantis, and human milk oligosaccharides (HMOs) in the stool were determined or quantified using 16S rRNA gene sequencing, metagenomic sequencing, qPCR, and mass spectrometry, respectively. No adverse events or tolerability issues related to EVC001 were reported. Control infants had no detectable levels of B. infantis. EVC001 infants achieved high levels of B. infantis (mean = 9.7 Log10 CFU/μg fecal DNA) by Study Day 14, correlating with less fecal HMOs (ρ = −0.83, P < 0.0001), indicating better HMO utilization in the gut. In this study, B. infantis EVC001 was shown to be safe, well-tolerated, and efficient in colonizing the preterm infant gut and able to increase the abundance of bifidobacteria capable of metabolizing HMOs, resulting in significantly improved utilization of human milk.Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03939546, identifier: NCT03939546.

Формування толерантності як професійної якості майбутнього вчителя

Future teacher personality formation is carried actively out in the Higher Education Institution, where the significant professional qualities, interests, creative abilities, values of future teachers are formed as well as the general level of their culture grows constantly. The author notes that in the conditions of professional pedagogical education the tolerance of future teachers increases on a regular basis. Today it is one of the most essential goals of professional pedagogical training. The article analyzes the content of the concept of tolerance; identifies types of future teacher tolerance; presents three important approaches of future teacher tolerance formation. The issues of tolerance have been researched for a long time. But so far the concept of tolerance, which would fully cover all the components of this quality and is suitable for every aspect of life activity, has not been elaborated yet. Thus, the problem of tolerance cannot be considered equally studied in theoretical, experimental and applied aspects. It is obvious that tolerance cannot be defined by one universal formula. It is an art, skill, ability, talent. Some people possess it by nature, others learn it hard. At the same time, a certain group of people will never achieve it. It is not enough for a modern person to have a natural talent to become a tolerant one. It is necessary to develop this quality every day. The focus on the main features of popular concepts of tolerance is vital. First of all, it should be noted that a tolerant person is friendly towards all people. The best teachers are always careful and know different educational needs of their students. Besides, the constant self-improvement is a sure way to succeed as a teacher. The article also examined that the main components of tolerance are: acceptance, understanding, imagination, knowledge, talent, determination, etc. These components should be developed by learning and practice successfully. The continuous development of the components will have the best effect on the process of tolerance formation.

Efficacy and safety of cariprazine augmentation in patients treated with clozapine: a pilot study.

Cariprazine, a novel antipsychotic drug, is a partial agonist of dopamine D2/D3 receptors with preferential binding to the D3 receptor. There has been an increasing interest in cariprazine augmentation to clozapine; however, the evidence thus far has been only limited to case reports and case series. To evaluate the efficacy and safety of the augmentation of clozapine with cariprazine in patients with sub-optimal treatment response. Demographic and clinical information of the study population were collected from the electronic records and PANSS scale administered at baseline and 3 months. Tolerability and discontinuation reasons where applicable were also recorded. Ten patients (four men and six women) with a mean age of 36.5 years (range = 26-45) were included. Reasons for cariprazine initiation included inadequate treatment response, persistent negative symptoms and/or tolerability issues with clozapine or previous augmentation options. Two patients discontinued cariprazine within the first 6 weeks due to restlessness and poor response, respectively. There was a significant reduction in the median total PANSS score from baseline to 3 months (from 59 to 22.5, p < 0.05), median positive PANSS score (from 11.5 to 5.5, p < 0.05) and in the median negative PANSS score (from 15.5 to 3, p < 0.05) which correspond to a 48%, 33.8% and 65.8% mean score reduction, respectively. This is the first pilot study evaluating the effectiveness of clozapine augmentation. The preliminary evidence suggests that this may be a safe and effective practice in patients failing to adequately respond to or tolerate clozapine and/or previous augmentation strategies.

Triangular Shape Hybrid Metal-Insulator-Metal Plasmonic Waveguide for Low Propagation Loss at Deep Subwavelength

The triangular shape based hybrid metal-insulator-metal plasmonic waveguide, to achieve the low propagation loss at deep-subwavelength, has been proposed, and analyzed for the optical properties of the fundamental mode, such as normalized effective mode area, propagation length, etc., at <inline-formula><tex-math notation="LaTeX">$1550{\rm{\ nm}}$</tex-math></inline-formula> of working wavelength. Due to the triangular type of high-index regions, the light is primarily confined at its tip-points, i.e., within the low-index materials. This type of waveguide structure can essentially provide the remarkably low propagation loss at deep subwavelength. The optical performance of fundamental hybrid mode is analyzed, by altering the waveguide dimensions, including the angle of triangular-shape high-index layer. Further, the investigation of mode character helps to understand the mode behavior of the proposed waveguide. The simulation results have established that the propagation length of fundamental hybrid mode of the presented waveguide can be achieved as &#x223C; 279.7 &#x03BC;m, with the normalized effective mode area of <inline-formula><tex-math notation="LaTeX">$\sim \ 0.4842$</tex-math></inline-formula>, at <inline-formula><tex-math notation="LaTeX">$w= 200\ nm$</tex-math></inline-formula>, <inline-formula><tex-math notation="LaTeX">${h_{si}} = \ 300\ nm$</tex-math></inline-formula>, <inline-formula><tex-math notation="LaTeX">${h_g} = \ 10\ nm$</tex-math></inline-formula>, and <inline-formula><tex-math notation="LaTeX">${h_m} = \ 100\ nm$</tex-math></inline-formula>; however, with other waveguide dimensions, <inline-formula><tex-math notation="LaTeX">${L_p}$</tex-math></inline-formula> has been achieved as, <inline-formula><tex-math notation="LaTeX">$ &gt; 700\ \mu m.$</tex-math></inline-formula> Further, the analysis on coupling length <inline-formula><tex-math notation="LaTeX">$( {{L_c}} ),$</tex-math></inline-formula> between the two nearby and similar type of the proposed waveguides, have been accomplished, and <inline-formula><tex-math notation="LaTeX">${L_c} &gt; 2500\ \mu m$</tex-math></inline-formula> has been attained for the waveguide separation, and width respectively of <inline-formula><tex-math notation="LaTeX">$800\ nm$</tex-math></inline-formula>, and <inline-formula><tex-math notation="LaTeX">$200\ nm$</tex-math></inline-formula>. Moreover, the phases of fabrication process, along with the tolerance issues in fabricating the tip-points of high-index regions, have been discussed for the proposed waveguide structure. The waveguide structure proposed in this work can be fundamentally effective for the proposal of various nano-photonic components, such as power splitter, directional coupler, etc.

Comparative analysis of modern fault tolerance technologies

On-demand cloud applications is one of the rapidly developing technologies that highly demanded on the market. With the increase of computer systems and requirements for real-time business intelligence, potential customers of such services turn to providers of «computing on demand» services. In the data centers that used for such services, computer systems face a large amount of processed data, which in turn leads to an imbalance in the load and provokes system failures. With infrastructure as a service (IaaS) usage, customers expect efficient performance of their tasks at an optimal price. In situation, when a client submits a task for work, it is deployed on a computer system in the data center of the service provider and there is no a hundred percent assurance that task would be completed and not failed because of lack of resources or software failure. Fault tolerance and high availability issues are currently the most acute in that field. The modern set of software tools for providing fault tolerance is quite wide. In general, they are all called to ensure the trouble-free operation of the computer system, but in fact they have significant differences in conceptual terms. High availability solutions provide fully automated failover to a backup system so that users and applications can continue working without disruption. HA solutions must have the ability to provide an immediate recovery point. At the same time, they must provide a recovery time capability that is significantly better than the recovery time that you experience in a non-HA solution topology. Analyzed and compared modern fault tolerance and high availability technologies. Compared modern models of High Availability system and tools for its implementation. Identified the shortcomings of modern models and tools for fault tolerance implementing. Developed recommendations for the usage of approaches that would help to eliminate reviewed shortcomings in different cases.

АКАДЕМІЧНА КУЛЬТУРА ГЕНДЕРНОЇ ТОЛЕРАНТНОСТІ В ОСВІТНЬОМУ ПРОСТОРІ

The main objective is to develop an academic culture of gender tolerance as a basis for the protection of the rights and freedoms of gender minorities in the educational realm. In today's conditions (including pandemics, rapid development of information and communication technologies, etc.) there is a need to actualize the issue of tolerance in human communication. The article is focused on the problem of gender tolerance, finding ways to develop the rights and freedom of gender minorities in the educational realm. It is noted that the formation of gender consciousness is a necessary condition for the development of modern personality, a manifestation of which should be gender tolerance. Educational institutions play a leading role here as centers of academic culture, where, in particular, respect and tolerance for people of different sexual orientations and gender identities are nurtured. Different approaches in defining the concepts of "tolerance" and "gender tolerance" are considered. It is defined that the study of gender tolerance in the educational realm requires the use of both synchronous and diachronic methods, the deployment of an integrative research strategy – transdisciplinarity. Effective tools and mechanisms for protecting the rights and freedoms of gender minorities in the educational process are proposed.

Management of Psychiatric Disorders in Patients with Hepatic and Gastrointestinal Diseases.

Management of Psychiatric Disorders in Patients with Hepatic and Gastrointestinal Diseases.

A phase I, randomized, double‐blind, placebo‐controlled, single‐ and multiple dose escalation study evaluating the safety, pharmacokinetics and pharmacodynamics of VX‐128, a highly selective Nav1.8 inhibitor, in healthy adults

Selective inhibition of certain voltage‐gated sodium channels (Navs), such as Nav1.8, is of primary interest for pharmacological pain research and widely studied as a pharmacological target due to its contribution to repetitive firing, neuronal excitability, and pain chronification. VX‐128 is a highly potent and selective Nav1.8 inhibitor that was being developed as a treatment for pain. We evaluated the safety, tolerability, and pharmacokinetics of VX‐128 in healthy subjects in a single‐ and multiple‐ascending dose (MAD) first‐in‐human study. Pharmacodynamics were evaluated in the MAD part using a battery of evoked pain tests. Overall, single doses of VX‐128 up to 300 mg were well‐tolerated, although adverse effect (AE) incidence was higher in subjects receiving VX‐128 (41.7%) compared with placebo (25.0%). After multiple dosing of up to 10 days, skin rash events were observed at all dose levels (up to 100 mg once daily [q.d.]), in five of 26 (19.2%) subjects, including one subject receiving VX‐128 (100 mg q.d.) who had a serious AE of angioedema. A trend in pain tolerance were observed for cold pressor‐ and pressure pain, which was dose‐dependent for the latter. VX‐128 was rapidly absorbed (median time to maximum plasma concentration between 1 and 2 h) with a half‐life of ~80 h at 10 mg q.d., and approximately two‐fold accumulation ratio after 10 and 30 mg q.d. Although VX‐128, when given in a multiple dose fashion, resulted in early study termination due to tolerability issues, effects were observed on multiple pain tests that may support further investigation of Nav1.8 inhibitors as pain treatments.

Shifting Issues of Support Exchange Under 20-Year Implementation of Japanese Long-Term Care Insurance Program

Japan has faced numerous issues in the last twenty years with its mandatory long-term care (LTC) insurance program. This LTC insurance program obviously affected older adults’ informal support exchanges, reducing support from family and the community, which became more valuable, subjectively. Furthermore, changes in support have impacted older adults’ subjective well-being and children’s perceived care motivation. Additionally, a mandatory uniform system challenges the issue of tolerance of diversity, meaning how non-traditional families’ opinions be involved LTC situations. This symposium discusses unexpected shifting issues in Japan in the implementation of a public LTC program with a focus on older adults’ support exchanges. The first paper examines the long-term impacts of formal and informal support by examining the effects of implementing formal services. The second paper assesses a community’s role in relation to family in the presence of a public LTC program. The third paper examines the subjective impacts of older parents, who provided support to adult children and their reciprocal expectations of receiving LTC. The fourth paper, on the other hand, articulates reciprocal impacts on sons’ care motivation, which has become more important, since the introduction of the LTC program reinforced men’s participation in LTC. Finally, the fifth paper clarifies how a public uniform program accommodates informal support from non-traditional families when the program premises the presence of family in advanced care planning. Our findings have long-term implications for aging societies in relation to formal and informal support exchanges.

COPEDOL: A two-year observational study in pretreated HIV-1-infected patients switching to a dolutegravir-based regimen

ObjectivesDolutegravir is a second-generation integrase strand transfer inhibitor of particular interest as a rescue treatment for people living with HIV (PLWHIV) who develop resistance to multiple antiretrovirals (ART). We assessed the virological treatment response in patients switched to a dolutegravir-based regimen following failure of previous ART treatment in a real-world treatment setting. Patients and methodsThis was a multicenter, longitudinal, observational study with retrospective patient enrolment. Patients were enrolled between February 2017 and January 2018. Patients starting dolutegravir treatment between February 2014 and September 2016 were retrospectively included. Patients were followed up for 24 months after dolutegravir initiation. During this period, treatment with dolutegravir could be discontinued at any time at the physician's discretion. Treatment failure was either defined as a viral load≥50 copies/mL at two consecutive blood samples or as clinical or biological safety issues. Overall, 459 patients were enrolled and 329 completed 24 months of treatment. The primary study outcome measures were treatment response and time to treatment response. Results346/440 patients (78.6%) achieved a treatment response; 86 patients discontinued dolutegravir treatment (of whom 17 for failure to achieve or maintain viral suppression and 38 for tolerability issues). Acquired dolutegravir-resistance mutations were identified in five patients. ConclusionsA sustained treatment response can be obtained with a dolutegravir-based treatment regimen in PLWHIV experiencing treatment failure, even in vulnerable patients with a long history of previous ART failure, infected with multidrug-resistant HIV strains, and with multiple comorbidities.

234. Dalbavancin versus Outpatient Parenteral Antimicrobial Therapy with Vancomycin for Treatment of Bone and Joint Infections in a Veteran Population

BackgroundDalbavancin is a long-acting lipoglycopeptide with broad gram-positive activity. A long half-life makes it an attractive treatment option for bone and joint infections (BJI). Previous studies have demonstrated efficacy of dalbavancin in the treatment of BJI. Based on these studies, our institution established a protocol for using dalbavancin as an alternative to IV antibiotics via PICC line. MethodsChart review was performed to compare outcomes of patients who were treated with dalbavancin versus vancomycin for BJI from 8/2017 –7/2020. Patients that received two doses of dalbavancin for BJI were compared with patients who received OPAT with vancomycin during the same time period. Patients were excluded if they were bacteremic or received dalbavancin for another indication. Data was collected from the Veterans Health Administration’s Corporate Data Warehouse and retrospective chart review. No statistical analyses were performed due to the descriptive nature of this study.ResultsA total of 59 patients were included; 25 received dalbavancin and 34 received vancomycin. Relevant differences in baseline characteristics included a higher proportion of patients with osteomyelitis (88% vs 74%) and refractory infection (64% vs 44%) in the dalbavancin group. More patients in the dalbavancin group (38% vs 24%) were readmitted for the same infection within one year, required (29% vs 21%) additional surgical intervention, and had increased CRPH on follow-up labs (32% vs 3%). Dalbavancin use likely expedited discharge in at least 5 cases where vancomycin levels were not therapeutic. No significant adverse effects due to dalbavancin were noted, aside from one patient with an increase in serum creatinine. In the vancomycin group, 8 patients changed antibiotics due to adverse effects or difficulty managing levels and 3 patients had ED visits for PICC line care.ConclusionDalbavancin may be a safe PICC-sparing treatment for BJI, particularly in cases where compliance is of concern, or there are logistical or tolerability issues with vancomycin. Our findings do raise concern for worse outcomes with dalbavancin, but the small sample size, difference in baseline characteristics between groups and descriptive nature of the study preclude any conclusions from being drawn. Disclosures All Authors: No reported disclosures

Effect and Tolerability of a Nutritional Supplement Based on a Synergistic Combination of β-Glucans and Selenium- and Zinc-Enriched Saccharomyces cerevisiae (ABB C1®) in Volunteers Receiving the Influenza or the COVID-19 Vaccine: A Randomized, Double-Blind, Placebo-Controlled Study.

A single-center, randomized, double-blind, placebo-controlled study was conducted in 72 volunteers who received a synergistic combination of yeast-based ingredients with a unique β-1,3/1,6-glucan complex and a consortium of heat-treated probiotic Saccharomyces cerevisiae rich in selenium and zinc (ABB C1®) or placebo on the next day after getting vaccinated against influenza (Chiromas®) (n = 34) or the COVID-19 (Comirnaty®) (n = 38). The duration of treatment was 30 and 35 days for the influenza and COVID-19 vaccine groups, respectively. Mean levels of CD4+T cells increased from 910.7 at baseline to 1000.2 cells/µL after the second dose of the COVID-19 vaccine in the ABB C1® group, whereas there was a decrease from 1055.1 to 929.8 cells/µL in the placebo group. Changes of CD3+T and CD8+T lymphocytes showed a similar trend. In the COVID-19 cohort, the increases in both IgG and IgM were higher in the ABB C1® supplement than in the placebo group. Serum levels of selenium and zinc showed a higher increase in subjects treated with the active product than in those receiving placebo. No serious adverse events related to ABB C1® or tolerance issues were reported. The study findings validate the capacity of the ABB C1® product to stimulate trained immunity.

Konsep Dasar Pendidikan Islam Inklusif : Studi Tentang Inklusivitas Islam Sebagai Pijakan Pengembangan Pendidikan Islam Inklusif

The paradigm shift in the inclusive Islamic education curriculum is an essential part of Presidential Decree No. 7 of 2021. There is a tendency for religious learning to be normative-indoctrinative and lead to truth claims, raising suspicions that religious education contributes to the generation of extreme views. PPIM UIN Jakarta research shows that the PAI curriculum is still ambiguous on the issue of tolerance, and there is a tendency for PAI teachers to have an intolerance opinion towards minorities by 34%, and towards adherents of other religions by 29%. This study discusses the concept of inclusive education in Islam, the urgency of inclusive Islamic education, and the paradigm shift from exclusive to inclusive. This research is a literature study with a rationalistic approach. Data analysis uses reflective thinking logically to interpret the inclusive values of Islamic education and reflect them into strategic steps to answer the challenge of exclusivity. This study shows that Islam carries an inclusive spirit characterized by terminologies such as at-ta'arruf, at-tasammuh, at-tawassuth, and at-ta'awun. The urgency of inclusive Islamic education is intended so that the character of inclusive Islam is truly taught in learning. To change the paradigm of Islamic education from exclusive to inclusive, improvements are needed in curriculum elements, educators, and learning strategies.