Clinical Research Methods Research Articles

Research Trends on the Effects of Forest Therapy in Korea and Ways to Improve the Level of Medical Evidence: A Scoping Review

Background and objective: Studies on the effects of forest therapy are clinical research that reveals the effects suitable for the purpose of therapy by applying a forest therapy program, which is a complex intervention, to humans in various forest environments. Accordingly, the purpose of this study is to find out the characteristics of existing studies on the effects of forest therapy and to suggest ways to improve the level of evidence for future research results. In this study, a scoping review was conducted to find out how studies on the effects of forest therapy were conducted based on the medical clinical research method in domestic studies on the effects of forest therapy.Methods: The scoping review utilized a procedure proposed by the Joanna Briggs Institute (JBI). A total of 564 studies were searched and 57 were used in the final analysis.Results: As a result of the analysis, only 1 study (1.8%) had a manual to reproduce the forest therapy program, and 56 studies (98.2%) reported only brief information on the program. As for the report on forest therapy environments, there were articles that mentioned some therapy environments, but none predicted the effects or reported about reproducibility. Among the reports on forest therapy environments, 21.1% reported about both forest and thermal environments, and 26.3% reported only about the forest environment.Conclusion: From the perspective of clinical research, the level of evidence for studies on the effects of forest therapy so far has been found to be very low, and methods for applying clinical research methods to improve this have been discussed. Clinical research is a prerequisite for verifying medical effects in order to raise the level of forest therapy from wellness to treatment support activities, and it must be actively utilized in the future.

Стан толерантності до фізичного навантаження та характеристика міокардіальних резервів у дітей, які перенесли COVID-19

Assessment of the state of exercise tolerance (ET) after the transfer of COVID-19 is necessary to determine the long-term consequences of the coronavirus disease. Purpose - to assess the state of ET and analyze changes in myocardial reserve indicators in children who have experienced COVID-19 of varying degrees of severity. Materials and methods. 155 school-age children took part in the study. 120 children with a confirmed diagnosis of COVID-19 in the anamnesis and a period after COVID-19 of more than 12 weeks (main group) and 35 healthy children who did not suffer from COVID-19 (control group). The Group I (n=49) included children who contracted mild COVID-19; the Group II (n=40) - children who suffered from COVID-19 of moderate severity, the Group III (n=31) - children who contracted COVID-19 with a severe course. General clinical, instrumental (cycle ergometry), and statistical research methods were used. Results. In the main group, the average value of maximum oxygen consumption (VO2max) was 26.86±6.69 ml/kg/min, and in the control group - 38.29±5.54 ml/kg/min (p<0.001). The analysis of this indicator in the Groups I, II, and III showed that transferred COVID-19 affects the level of ET in boys regardless of the severity of COVID-19 (p<0.01). In girls, reduced ET was determined in the case of moderate and severe course of COVID-19. The analysis of myocardial reserves indicators showed that among children who fell ill with COVID-19, the worst indicators were observed in the Groups II and III (p<0.01). Conclusions. Transmitted COVID-19 affects the state of ET and indicators of myocardial reserves in children in the period more than 12 weeks after COVID-19. The level of changes in the state of ET, values of the cardiac and vascular component of physical load support, and myocardial reserves depend on the degree of severity of the transferred COVID-19, which is confirmed by correlations of varying strength between these indicators and the degree of severity of COVID-19. The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of the participating institution. The informed consent of the patient was obtained for conducting the studies. No conflict of interests was declared by the authors.

Clinical significance of micronutrient status and vaginal microbiocenosis in pregnant women and correction of indentified disorders

Objective: to conduct a clinical analysis and evaluate the significance of micronutrient status and vaginal microbiocenosis in pregnant women and develop a method for correcting the identified disorders based on the use of Bellakt Mama+ powdered milk product. Materials and methods. We conducted a prospective study on the basis of the professorial advisory center of the EE “Grodno State Medical University”. In the course of the work, we examined 110 pregnant women, 55 of whom took Bellakt MAMA + dry milk product for 3 months, and the second half were observed only according to the clinical protocol. The assessment was made: anamnestic - assessment of the anamnesis of life and disease; generally accepted clinical, laboratory and instrumental (ultrasound examination of the pelvic organs) research methods. Performed blood sampling from the cubital vein in the morning on an empty stomach with the determination of the levels of ferritin, calcium i, iron, total vitamin D, folic acid, osteocalcin. An assessment of the biocoenosis of the urogenital tract was carried out “Femoflor Screen”; statistical processing of the results was carried out. Results. We found that in patients who took a dry dairy product of Belarusian production, a persistent positive trend in the increase in the level of folic acid (p = 0,0049), total vitamin D (p = 0,0041), serum iron (p = 0,0041) was established, ferritin (p = 0,0040), as well as improvement of the vaginal biocoenosis (p = 0,0040). There were no statistically significant differences in the levels of ionized calcium and osteocalcin. It should be noted that the patients of the main group had no complaints of discomfort in large joints, bones and cramps in the calf muscles, in contrast to the women of the control group. Conclusion. The above results confirm the need to control and correct micronutrient deficiency and vaginal dysbiosis in women at the stage of preconception preparation and in the first trimester of pregnancy.

The rationale for the choice of preventive intraoperative anesthesia for uterine curettage in patients with individual intolerance to amide anesthetics

Background. Uterine curettage (UC) is widely used in global clinical practice owing to its great diagnostic and therapeutic value. At the same time, UC leads to a damage to the integrity of soft tissues, causing development of postoperative pain syndrome. Some patients have an individual intolerance to amide anesthetics, which limits their use in this cohort. Purpose: to improve the quality of providing anesthetic care in the early postoperative period after UC to women who have a history of individual intolerance to amide anesthetics through selection of a comprehensive method of preventive intraoperative anesthesia for this category of patients. Materials and methods. Ninety females took part in the study. Clinical, laboratory, and mathematical and statistical research methods were used to study the preventive analgesic effectiveness of the compared methods of anesthesia. Five samples of biological material, called the control points, were taken: before surgery, immediately after it, then 1, 3 and 6 hours after intervention. In this way, an idea was got about the initial level of the studied indicators and their changes during the postoperative stay in the hospital. Properties of various combinations of propofol, ketamine, fentanyl, and dexketoprofen were studied. Results. It was revealed that a combination of propofol (2 mg/kg), fentanyl (0.1 µg/kg), ketamine (0.1 mg/kg), as well as additional intravenous administration of dexketoprofen (50 mg) at the stage of premedication has the advantages in terms of preventive intraoperative analgesia. Effectiveness of the proposed method of anesthesia was proved by significantly better indicators of vital functions (heart rate, mean arterial pressure) and serum levels of some laboratory markers of stress (glucose, cortisol, insulin, cortisol-insulin index). Differences in the studied parameters were recorded both when comparing them between the groups at the same control time points and conside-ring the development and regression of the postoperative pain syndrome severity within the groups. Conclusions. The proposed method of anesthesia has a reliable advantage in terms of preventive reduction of the postoperative pain syndrome of UC in patients who cannot have application anesthesia due to individual intolerance to amide drugs. The specified method has a positive effect on vital functions and serum levels of some laboratory markers of stress, and the fastest recovery of patients is caused by a lower suppressive action of the anesthetic drugs used.

Characteristics of speech function in the process of patients getting used to removable dentures

Relevance. The study of the attitude to the disease of dental patients during the adaptation period with the use of conventional clinical research methods is relatively rarely covered in the available domestic and foreign literature. Objective. To study the changes of internal disease pattern after the adaptation period completion in rehabilitation of patients with full tooth loss by full removable acrylic dentures, including the use of such orthopedic dental prosthesis together with the adhesive agent, designed to improve their fixation. Materials and methods. 48 (15 men and 33 women) elderly patients (61–74 years old) with a total loss of teeth were examined and were divided into 2 study groups: 1 – comparison group; 2 – main group. There were also examined 17 elderly people who had no defects of dental rows and formed a control group. The defects of dental rows in the patients of the 1st and 2nd groups were eliminated by making removable dentures. At the same time, during the adaptation period the patients of the second group of the study used a new domestic adhesive cream Aceptа Рarodontal with an extract of medicinal herbs for fixation of dentures. Before treatment and during the adaptation period the types of patients’ relation to the disease were investigated; for this purpose the clinical technique «Type of relation to the disease» (TORD) was usedResults. It was found that while preserving the integrity of dental rows in elderly people the types of attitude to the disease included in the conditionally adaptive block were mainly marked. At the end of adaptation period if all patients of the main group 2 had the types of attitude towards the disease included in the first conditionally adaptive block, then the patients of the comparison group 1 in only 39.1% of people revealed similar types of attitude towards the disease, which testified to the problems in adaptation to new removable acrylic dentures made for the treatment of complete tooth loss. Conclusion. The use of ASEPTA РARODONTAL adhesive cream with herbal extracts by patients provides a positive correction of the internal picture of the disease and the patient’s personal reaction to the treatment. On the basis of the carried out research it is possible to recommend to patients the domestic adhesive cream ASEPTA РARODONTAL for denture fixation in order to optimize the adaptation period to removable acrylic dentures as well as for permanent use, which will improve not only fixation and stabilization of dentures, condition of denture bed mucosa, but also quality of speech function.

Systematic review of research barriers, facilitators, and stakeholders in long-term care and geriatric settings, and a conceptual mapping framework to build research capacity

BackgroundOlder adults are underrepresented in research. Heterogeneity of research processes in this population, specifically in long-term care (LTC) and geriatric acute care (GAC), is not well described and may impede the design, planning, and conduct of research. In this study, we identified, quantified, and mapped stakeholders, research stages, and transversal themes of research processes, to develop a mapping framework to improve research capacity by better characterizing this heterogeneity.MethodsMulticomponent mixed methods study. An environmental scan was used to initiate a preliminary framework. We conducted a systematic literature search on processes, barriers, and methods for clinical research in GAC and LTC to extract and update stakeholders, research stages, and themes. Importance and interactions of elements were synthesized via heatmaps by number of articles, mentions, and content intersections.ResultsFor our initial framework and environmental scan, we surveyed 24 stakeholders. Of 9277 records, 68 articles were included in our systematic review and allowed us to identify 12 stakeholders, 13 research stages, 17 transversal themes (either barriers, facilitators, general themes, or recommendations), and 1868 intersections. Differences in relative importance between LTC and GAC emerged for stakeholders (staff, managers vs. caregivers, ethics committees), and for research stages (funding, facility recruitment vs. ethics, individual recruitment). Crucial themes according to specific stakeholders were collaboration for the research team; communication, trust, and human resources for managers; heterogeneity for patients and residents. A heatmap framework synthesizing vital stakeholders and themes per research stage was generated.ConclusionsWe identified and quantified the interactions between stakeholders, stages, and themes to characterize heterogeneity in LTC and GAC research. Our framework may serve as a blueprint to co-construct and improve each stage of the research process.

Protocol of the Berlin Long-term Observation of Vascular Events (BeLOVE): a prospective cohort study with deep phenotyping and long-term follow up of cardiovascular high-risk patients

IntroductionThe Berlin Long-term Observation of Vascular Events is a prospective cohort study that aims to improve prediction and disease-overarching mechanistic understanding of cardiovascular (CV) disease progression by comprehensively investigating a...

Роль магнію в організмі здорової людини в перебігу і реабілітації після респіраторної інфекційної патології та COVID-19 (відомості літератури, власні дані)

Magnesium is a macroelement that plays an important role in the regulation of many physiological processes. In the case of insufficient intake of magnesium, which does not meet the needs of the child's body, its deficiency develops. Clinical manifestations of magnesium deficiency are nonspecific and may be similar to symptoms of various diseases, including asthenic syndrome. In turn, asthenic syndrome is common in children who have suffered infectious diseases, COVID-19, influenza, and other acute respiratory infectious pathology. In such children, excessive anxiety, rapid fatigue, sudden mood changes, sleep disorders, and emotional lability can be detected. Given that the leading role in ensuring the proper functioning of most of the body's enzyme systems, tissue respiration, energy exchange, and synthetic processes belongs to magnesium, it is assumed that the development of the described symptoms may be related to its deficiency. Purpose - to summarize literature data on the role of magnesium in the body of a healthy person, the peculiarities of its metabolism, its importance in the course and rehabilitation after respiratory infectious pathology and COVID-19, signs of deficiency, and methods of its correction; evaluate the results of own research. Materials and methods. General clinical (analysis of anamnesis data), laboratory (determination of magnesium level in blood serum), statistical, bibliographic, and information-analytic research methods were used. 60 children aged 9 to 18 took part in the study, among them 35 children who had COVID-19 (the first group) and 25 children who did not have COVID-19 (the second group). Results. It was established that the average value of magnesium level in blood serum in children of the first group was lower than in children of the second group (p=0.005). Individual analysis showed that 31.4% of patients in the first group, who had a term of 4-5 months after COVID-19, noted the presence of post-COVID-19 symptoms, such as excessive fatigue, headache, muscle weakness, impaired sleep, appetite, which coincides with the data of the literature. Conclusions. The data of our study may indicate the effect of transferred COVID-19 on the level of magnesium in the blood serum, which may be one of the reasons for its deficiency and, accordingly, the development of post-COVID-19 symptoms in children. It is advisable to carry out laboratory determination of the magnesium level in children who had acute respiratory infectious pathology, including COVID-19, to establish the causes of the development of individual symptoms that aggravate the general well-being, prevent the development of magnesium deficiency and find additional ways of rehabilitation after respiratory infectious pathology and COVID-19. No conflict of interests was declared by the authors.

B-339 A Clinical Research LC-MS/MS Method for the Analysis of Antidepressants in Plasma

Abstract Background Depression is common globally, with an estimated 3.8% of the population affected. The condition can impact individuals’ ability to function in work, social and family settings. Many antidepressant drugs are currently prescribed, encompassing selective serotonin reuptake inhibitors (SSRIs), serotonin-nonresponsive reuptake inhibitors (SNRIs) and tetracyclic antidepressants (TeCAs). However pharmacokinetic and drug interactions are known, therefore a reliable quantitative clinical research method may play a role in researching the effects of their administration. Waters has developed a clinical research method for the following antidepressants in plasma; citalopram, desmethylfluoxetine, duloxetine, fluoxetine, fluvoxamine, O-desmethylvenlafaxine, sertraline and venlafaxine (10–1000 ng/mL); mirtazapine (5–500 ng/mL) and trazadone (30–3000 ng/mL). Methods Matrix matched calibrators and QCs were prepared using in-house stocks and pooled plasma. Samples (50 µL) were treated with internal standard in acetonitrile. A water/methanol/ammonium acetate gradient was used with a Waters™ XSelect™ Premier HSS T3 column on a Waters ACQUITY™ UPLC™ I-Class followed by detection on a Xevo® TQD mass spectrometer in a 5 min run. Results No system carryover was observed following analysis of plasma samples containing the highest concentration calibrators. Analytical sensitivity investigations indicated precise quantification (≤20% CV, ≤17.6% bias) at concentrations equal to or lower than the lowest concentration calibrator. Total precision and repeatability were assessed (3 pools, 5 replicates, 5 days; n = 25) and determined to be ≤10.0% RSD. Linearity experiments determined the method provided first or second order fits over the ranges analyzed; additionally, each run met acceptance criteria (coefficient of correlation ≥ 0.995, determined concentrations of calibrators ±15% of nominal, ±20% in the case of the lowest calibrator). Post-column infusion experiments demonstrated analytes eluted in regions free of major ion suppression or enhancement. Evaluation of matrix effects at low and high concentrations indicated compensation by the internal standard. Addition of high concentrations of several endogenous and exogenous materials did not affect quantification. Conclusion This quantitative method for clinical research demonstrates very good precision with minimal matrix effects and allows for the multiplexing of a panel of antidepressants in plasma in a short run time. For Research Use Only. Not for Use in Diagnostic Procedures.

Гістеректомія в період менопаузального переходу як предиктор метаболічних порушень

Although data on the decrease in ovarian function after hysterectomy (GE) are found in literature sources, the nature of changes in the hormonal and metabolic profile, its chronological sequence, the issue of the relationship with the development of metabolic syndrome (MS), even in the case of preservation of ovarian tissue, remain controversial and fragmented, which served as an impetus for conducting this study. Purpose - to assess the risk of metabolic disorders after GE during the menopausal transition. Materials and methods. A comprehensive assessment of the long-term consequences of GE was carried out in 160 women of the menopausal transition age. Metabolic homeostasis parameters were evaluated before surgery and in dynamics after surgical intervention (after 12 months). Risk factors were identified during a general clinical examination, based on anamnestic data. Indicators of carbohydrate and lipid metabolism were evaluated in the examined women. Inclusion criteria: the age of the menopausal transition, GE due to benign uterine pathology, the patient's consent to participate in the research. Results. Analysis of carbohydrate metabolism indicators showed an increase in the HOMA-IR index and postprandial glucose level, changes in the lipid profile. When comparing clinical symptoms and laboratory research methods, in 34.37% of cases, the formation of MS was noted one year after GE. Based on multivariate analysis using binary logistic regression, the following risk factors for metabolic disorders were found to be statistically significant: high body mass index, waist circumference above 80 cm, age older than 45, climacteric syndrome, GE. Conclusions. A high body mass index, a waist circumference greater than 80 cm, the presence of signs of the climacteric syndrome, GE and age older than 45 years show the association with the development of metabolic disorders in the distant postoperative period, and their combined effect increases the risk of their development. These factors at the preoperative stage can serve as prognostic markers of metabolic disorders in the distant postoperative period. The research was carried out in accordance with the principles of the Helsinki Declaration. The study protocol was approved by the Local Ethics Committee of the participating institution. The informed consent of the patient was obtained for conducting the studies. No conflict of interests was declared by the authors.

Using a Mobile Messenger Service as a Digital Diary to Capture Patients' Experiences Along Their Interorganizational Treatment Path in Gynecologic Oncology: Lessons Learned.

A digital diary in the form of a mobile messenger service offers a novel method for data collection in cancer research. Little is known about the things to consider when using this data collection method in clinical research for patients with cancer. In this Viewpoint paper, we discuss the lessons we learned from using a qualitative digital diary method via a mobile messenger service for data collection in oncology care. The lessons learned focus on three main topics: (1) data quality, (2) practical aspects, and (3) data protection. We hope to provide useful information to other researchers who consider this method for their research with patients. First, in this paper, we argue that the interactive nature of a digital diary via a messenger service is very well suited for the phenomenological approach and produces high-quality data. Second, we discuss practical issues of data collection with a mobile messenger service, including participant and researcher interaction. Third, we highlight corresponding aspects around technicalities, particularly those regarding data security. Our views on data privacy and information security are summarized in a comprehensive checklist to inform fellow researchers on the selection of a suitable messenger service for different scenarios. In our opinion, a digital diary via a mobile messenger service can provide high-quality data almost in real time and from participants' daily lives. However, some considerations must be made to ensure that patient data are sufficiently protected. The lessons we learned can guide future qualitative research using this relatively novel method for data collection in cancer research.

Эффективность радиоволновой хирургии доброкачественных новообразований век

Purpose. To evaluate the effectiveness of radiowave method for the treatment of benign neoplasms of the eyelids. Methods. The study involved 87 patients with various pathologies (operated in 2 ways): chalazions, xanthelasma, papillomas, non -pigmented nevis, atheromas, retention cysts of the eyelids. The diagnoses were confirmed by clinical and laboratory research methods (cytological and histological examination). In both groups of patients clinical effect of the treatment, healing time of the wound surface and the cosmetic results of classical surgical and radio wave treatment (“Surgitron”) were evaluated. Results.Radiosurgical method, in contrast to the classic surgical method, showed low traumatism, high cosmetic results in 100 % of cases, healing occurred by primary intention and no recurrence of the pathology was observed in any case. Conclusion.The use of radio wave method had demonstrated high efficiency, safety and good cosmetic effect in the treatment of benign neoplasms of the eyelids. Key words: eyelid neoplasm; radiowave surgery; cosmetic results.

Guidelines on clinical research evaluation of artificial intelligence in ophthalmology (2023).

With the upsurge of artificial intelligence (AI) technology in the medical field, its application in ophthalmology has become a cutting-edge research field. Notably, machine learning techniques have shown remarkable achievements in diagnosing, intervening, and predicting ophthalmic diseases. To meet the requirements of clinical research and fit the actual progress of clinical diagnosis and treatment of ophthalmic AI, the Ophthalmic Imaging and Intelligent Medicine Branch and the Intelligent Medicine Committee of Chinese Medicine Education Association organized experts to integrate recent evaluation reports of clinical AI research at home and abroad and formed a guideline on clinical research evaluation of AI in ophthalmology after several rounds of discussion and modification. The main content includes the background and method of developing this guideline, an introduction to international guidelines on the clinical research evaluation of AI, and the evaluation methods of clinical ophthalmic AI models. This guideline introduces general evaluation methods of clinical ophthalmic AI research, evaluation methods of clinical ophthalmic AI models, and commonly-used indices and formulae for clinical ophthalmic AI model evaluation in detail, and amply elaborates the evaluation methods of clinical ophthalmic AI trials. This guideline aims to provide guidance and norms for clinical researchers of ophthalmic AI, promote the development of regularization and standardization, and further improve the overall level of clinical ophthalmic AI research evaluations.

Clinical and anamnestic characteristics of patients with negative symptoms in schizophrenia

252 patients with negative symptoms of schizophrenia and 79 patients with positive symptoms of schizophrenia were examined. A comprehensive approach was used, consisting of a combination of clinical and anamnestic, clinical and psychopathological and statistical research methods. The assessment of clinical and psychopathological features in patients with schizophrenia included the analysis of the distribution of patients according to the severity of forms, type and manifestations of schizophrenia, duration and progressivity of the disease and episodes, number of relapses, hospitalizations and features of leading symptom complexes. Features of the clinical picture of patients with negative and positive symptoms in schizophrenia were determined, which can use as diagnostic criteria for differential diagnosis and selection of treatment strategies for patients with schizophrenia Key words: negative symptoms, positive symptoms, schizophrenia, clinical characteristics, clinical and anamnestic analysis

Evaluation of surgical treatment results in elderly patients with lumbar spinal stenosis

Background: Lumbar spinal stenosis in elderly patients is a common pathology and the biggest cause of the indication for spinal surgery. Our aims are to study clinical and subclinical characteristics and evaluate TLIF surgery results in elderly patients with lumbar spinal stenosis. Materials & methods: A total of 45 lumbar spinal stenosis patients were treated with TLIF surgery from June 2018 to March 2021. Using a follow-up, clinical descriptive research method. Evaluate before surgery and follow up until 1 year after operation. Results: The average age was 67.96 ± 5.701. The classification of patients admitted to hospital was 33.3% crippled and 66.7% paralyzed according to the ODI. MRI showed 91.1% absolute stenosis, 8,9% relative stenosis. There were no surgical accidents. The complication rate after surgery was 6.6%. 12 months after surgery, VAS back pain decreased to 1.16 ± 1.33, VAS leg pain decreased to 0.80 ± 0.99, JOA increased to 23.73 ± 3.61, ODI decreased to 26.89 ± 10.98. 93.3% recovery rate classified as excellent and good according to Hirabayashi. Conclusions: TLIF surgery on elderly patients brought good results. Key words: lumbar spinal stenosis; TLIF surgery; elderly patients; Japanese Orthopaedic Association score; Oswestry Disability Index.

Clinical and biochemical markers of neurodegenerative process in Alzheimer's disease

Recently, numerous studies have been devoted to describing the heterogeneity of Alzheimer's disease (AD). The aim of our work was to study the clinical, biochemical, and neuropsychological signs of AD depending on the form of the disease. The study involved 173 patients with AD, of whom 65 patients with early onset and 108 with late onset at the stage of moderate cognitive impairment. All study participants underwent the Montreal Cognitive Assessment Scale (MoCA test), the Free and Cued Selective Reminding Test with Immediate Recall (FCSRT-IR), and a lumbar puncture with the determination of the levels of Aβ42 and Aβ40 biomarkers in the cerebrospinal fluid by enzyme immunoassay. The mean age of the patients with early onset of AD was 65.1±0.3 years, and with late onset - 78.6±0.5 years. According to our data, it was found that the majority of the patients with late-onset AD had a longer education (p=0.000) and had coffee more often (p=0.000) than the study participants with early onset of AD. We did not reveal the effect of alcohol and smoking on the neurodegenerative process. The patients with early-onset AD scored lower on the MoCA test than those with late-onset AD (p=0.000). The results of free recall and cue index on the FCSRT-IR test in the patients with late AD were significantly lower than in the patients with early AD onset (p<0.001). We found that the level of Aβ42 and the ratio of Aβ42/Aβ40 in the cerebrospinal fluid was significantly lower (p=0.000) in the patients with early AD onset. The results of our study prove the need for an integrated approach to diagnosing AD using clinical, neuropsychological,and biochemical research methods.

Efficacy of ultraphonophoresis with an enzyme gel with high transcutaneous and proteolytic activity in patients with atrophic skin scars: a prospective interventional cohort comparative study

Introduction. The trend towards an increase in peacetime and wartime injuries and the frequent formation of severe cicatricial dysplasia dictate the need to develop an effective, universal, and widely available method for the prevention and correction of fibrotic skin deformities applied by doctors of various specialties: dermatocosmetologists, physiotherapists, and rehabilitologists. In addition to persistent irreversible structural damage and a visible skin defect, patients are concerned about itching and other subjective sensations in the scar area. Physical methods of correction using transdermal deliveries of enzyme fibromodulatory drugs are scientifically substantiated and are widely used in the rehabilitation period of patients with scars of various origins. Meanwhile, the therapeutic possibilities of influencing the subjective sensations of this group of patients remain only partially studied up to date. Materials and methods. A prospective interventional cohort comparative study of the efficacy and safety of using the ultraphonophoresis technique with an enzyme gel with a high transcutaneous and proteolytic ability in patients with atrophic skin scars was carried out. The study included 56 patients with a diagnosis of «atrophic scars» (ICD-10 Chapter XII: Diseases of the skin and subcutaneous tissue, L90). The entire sample was divided into groups with developing (n=27) and mature (n=29) scars. As a result of random distribution, the study subgroups (groups 1, 3 n=14 and n=15) and comparison subgroups (groups 2, 4 n=13 and n=14), in which the patients were prescribed topical therapy with traditionally used anti-scar drugs, were formed. During the study, clinical, instrumental, and medico-sociological research methods were used. Results. In the study groups, a high safety profile of gel ultraphonophoresis procedures and more significant changes in the macro-relief of the scar, instrumental indicators, and quality of life indicators have been established. Conclusion. The method of ultraphonophoresis with an enzyme gel with high transcutaneous and proteolytic activity in patients with atrophic skin scars has been scientifically substantiated and tested. The effectiveness of the treatment complex is 84–88 %.

Total Knee Arthroplasty for Contractures in Patients with Rheumatoid Arthritis

Summary. Knee joint injury in patients with rheumatoid arthritis (RA) occurs in 70% of cases. This is the most common cause of loss of work capacity and the ability to selfcare; patients become severely disabled, since the disease is accompanied by contractures with the development of discordant positions of the lower limbs, which leads to a partial or complete loss of the function of support and walking. Thus, this problem needs to be studied.
 Objective: to analyze the orthopedic treatment of secondary arthrosis of the knee joints in patients with RA, complicated by contractures.
 Materials and Methods. In this study, we have analyzed the orthopedic treatment of 66 RA patients with secondary arthrosis with contractures, who underwent 75 total knee replacements between 2013 and 2020. Anamnestic data, clinical, biomechanical and statistical research methods were used.
 Results. The analysis of the results of total knee replacement was followed in the period from 6 months to 5 years. The results were evaluated according to the 100-point scale by J. Joseph,
 E.E. Kaufman (1550). The majority of patients had good treatment results.
 Conclusions. Total knee replacement is required in patients with 2nd phase of the stage II of the disease and higher. In our opinion, this is the most optimal time for surgical treatment, which allows patients with RA to fully use the capabilities of an implanted endoprosthesis.

Катамнез детей с врожденной цитомегаловирусной инфекцией в зависимости от этиотропной терапии на первом году жизни

Cytomegalovirus infection (CMVI) continues to be a serious public health problem, being second to hypoxia and asphyxia in the list of reasons of morbidity and mortality of newborns. This study aimed to analyze therapeutic approaches to management of children with congenital cytomegalovirus with the regimens including an antiviral drug (direct action) and a specific anti-cytomegalovirus immunoglobulin (anti-CMV IG), depending on the clinical form of the disease. The total number of participants was 62, with the first group of children receiving the antiviral drug (n = 21), and the second group — an anti-CMV IG (n = 41). We analyzed the clinical, laboratory and instrumental research methods, and studied the catamnesis of children under 3 years of age. For statistical analysis, we used SPSS Statistics and StatTech v.3.1.6. In the first group, where the regimen included the direct action antiviral drug, the outcome was successful for 28.6% of the participants, and in the second group, which was treated with the anti-CMV immunoglobulin, this figure was 58.5%. Regardless of the regimen, by the age of 3, 50% of the children were practically healthy. Most of the participants tolerated the therapy satisfactorily. However, for 66% of the involved children, we had to shorten the direct action antiviral drug therapy to 14 days because of the problems with venous access, in 4.8% we registered thrombocytopenia, and in 9.5% — increased transaminase activity. Comparing the disease outcomes depending on the therapy initiation day, we established significant differences only for the specific antiviral therapy cases (p = 0.044).

Style transfer generative adversarial networks to harmonize multisite MRI to a single reference image to avoid overcorrection.

Recent work within neuroimaging consortia have aimed to identify reproducible, and often subtle, brain signatures of psychiatric or neurological conditions. To allow for high-powered brain imaging analyses, it is often necessary to pool MR images that were acquired with different protocols across multiple scanners. Current retrospective harmonization techniques have shown promise in removing site-related image variation. However, most statistical approaches may over-correct for technical, scanning-related, variation as they cannot distinguish between confounded image-acquisition based variability and site-related population variability. Such statistical methods often require that datasets contain subjects or patient groups with similar clinical or demographic information to isolate the acquisition-based variability. To overcome this limitation, we consider site-related magnetic resonance (MR) imaging harmonization as a style transfer problem rather than a domain transfer problem. Using a fully unsupervised deep-learning framework based on a generative adversarial network (GAN), we show that MR images can be harmonized by inserting the style information encoded from a single reference image, without knowing their site/scanner labels a priori. We trained our model using data from five large-scale multisite datasets with varied demographics. Results demonstrated that our style-encoding model can harmonize MR images, and match intensity profiles, without relying on traveling subjects. This model also avoids the need to control for clinical, diagnostic, or demographic information. We highlight the effectiveness of our method for clinical research by comparing extracted cortical and subcortical features, brain-age estimates, and case-control effect sizes before and after the harmonization. We showed that our harmonization removed the site-related variances, while preserving the anatomical information and clinical meaningful patterns. We further demonstrated that with a diverse training set, our method successfully harmonized MR images collected from unseen scanners and protocols, suggesting a promising tool for ongoing collaborative studies. Source code is released in USC-IGC/style_transfer_harmonization (github.com).