World Medical Association Declaration Research Articles

A randomised trial of short- vs long-term androgen deprivation with salvage radiotherapy for biochemical failure following radical prostatectomy: URONCOR 06-24.

Salvage radiotherapy (SRT) and androgen-deprivation therapy (ADT) are widely used in routine clinical practice to treat patients with prostate cancer who develop biochemical recurrence (BCR) after radical prostatectomy (RP). However, there is no standard-of-care consensus on optimal duration ADT. Investigators propose three distinct risk groups in patients with prostate cancer treated with SRT in order to better define the indications and duration of ADT combined with SRT. The URONCOR 06-24 trial (ClinicalTrials.gov identifier NCT05781217) is a prospective, multicentre, randomised, open-label, phase III, clinical trial. The aim of the trial is to determine the impact of short-term (6 months) vs long-term (24 months) ADT in combination with SRT on distant metastasis-free survival (MFS) in patients with prostate cancer with BCR after RP (intermediate and high risk). The primary endpoint is 5-year MFS rates in patients with prostate cancer treated with long- vs short-term ADT in combination with SRT. Secondary objectives are biochemical-relapse free interval, pelvic progression-free survival, time to start of systemic treatment, time to castration resistance, cancer-specific survival, overall survival, acute and late toxicity, and quality of life. Total of 534 patients will be randomised 1:1 to ADT 6 months or ADT 24 months with a luteinizing hormone-releasing hormone analogue in combination with SRT, stratified by risk group and pathological lymph node status. The study is conducted under the guiding principles of the World Medical Association Declaration of Helsinki. The results will be disseminated at research conferences and in peer-reviewed journals. EudraCT number 2021-006975-41.

ON THE QUESTION OF THE EFFECT OF REGENERATION STIMULATION DRUGS ON THE RESTORATION OF THE SKIN IN CASE OF INJURY

Background. The study of the reaction of tissue (epidermis and dermis) to the medication of regeneration stimulants (МSR) in injuries is relevant both for the development of wound coatings and treatment regimens for the traumatic process. In this study, special attention is paid to the process of stimulation of stem cells in the hair papilla, which play an important role in the restoration of skin structures. The aim of the study was also to study the morphological changes of the epidermis and dermis in the dynamics of trauma. Materials and methods. To conduct the experiment, experimental groups were formed: a burn model without treatment; a burn model with a МSR preparation (oral administration and wound coating); an experimental group with a linear wound with МSR treatment, an experimental group similar reproduction of a wound without suturing with МSR, a control group similar reproduction of a wound without treatment with suturing, a control group - similar reproduction of the wound without treatment and without suturing. Animals were removed from the experiment by inhalation of ether vapors in accordance with the "Rules for carrying out work using experimental animals" and in accordance with the principles of the Helsinki Declaration of the World Medical Association (Declaration of Helsinki, and approved by the Institutional Review Board). Tissue fragments were taken from the site of thermal trauma and healthy tissue for the preparation of histological preparations. The production of paraffin histological sections with a thickness of 5-7 microns was carried out according to generally accepted standard methods. The sections were stained with hematoxylin and eosin. The photos were taken using the Vision Bio system (Epi 2014) and stained with hematoxylin-eosin, which were examined under x100 magnification. The obtained data were processed using MS Excel and Statgraphics software packages using generally accepted methods of statistics. Results. When reproducing thermal trauma In the control group on day 14, there is no epidermis in part of the visual fields within the studied material, the layers are replaced by connective tissue strands, scar tissue is visualized. The dermis is moderately edematous, with neutrophilic and lymphocytic infiltration is weakly expressed, in the papillary and reticular layer it is evenly represented, there are single apoptotic corpuscles. No areas of hemorrhage were detected, but the blood vessels were dilated. While in the experimental group there are signs of restoration of microcirculation with a large number of vessels and a more pronounced layer of the epidermis. When examining scars after a linear wound, it was found that animals who did not receive therapy have a thin scar, and in animals who received МSR, the consequences of surgical intervention are not visualized. Conclusion. The dynamics of the wound process was studied when using a prototype ointment containing a regeneration complex in the treatment of burn and linear wounds in an experiment. The effectiveness of the regenerative complex of a prototype ointment for the treatment of experimental burn and linear wounds in laboratory animals in comparison with the control group was revealed. It has been established that in the treatment of burn and linear wounds with experimental ointment, the healing period of burn wounds is reduced due to more active formation of the microcirculatory bed and the early onset of epithelization.

MATHEMATICAL PREDICTION OF CHANGES IN THE LEVELS OF CD40-CD40L TRANSMEMBRANE PROTEIN SYSTEM ACROSS DIFFERENT ANALGESIA TECHNIQUES IN CHILDREN

The impact of the CD40-CD40L on the development of non-communicable neurological conditions is determined by abnormal CD40 expression and may be detrimental to nervous tissue function. Pain is one of the earliest psychophysical functions to develop. Postoperative complications causing pain should be addressed immediately. Regional analgesia techniques can speed up children’s recovery and reduce the need for opioids. They can also lower the incidence of postoperative nausea and vomiting, respiratory complications, and postsurgical pain intensity.The aim of this study was to present a mathematical model that predicts changes in CD40-CD40L levels in children who underwent surgery under various analgesic modalities within the fi rst fi ve days postoperatively. The autoregressive probability model was used to predict the behavior of the experimental data function within 29 days after surgery.Material and Methods. The children were divided into three groups. Group I consisted of 33 children who underwent anterior abdominal wall surgery under general anesthesia with morphine. Group II comprised 27 children who underwent anterior abdominal wall surgery under general anesthesia with the transversalis fascia plane block (TFPB). Group III included 27 children who underwent anterior abdominal wall surgery under general anesthesia with the TFPB, combined with the quadratus lumborum block 4 (QLB-4) via a single injection. The serum CD40L levels were evaluated using the immunoenzymatic assay method. The autoregressive model method based on the Burg algorithm was used to predict the behavior of the experimental data function. To automate the calculation of predictions based on the Burg method, the ‘predict’ function in РТС MathCad Prime 7.0 software was used. All clinical and laboratory studies were conducted in accordance with the World Medical Association Declaration of Helsinki ‘Ethical Principles for Medical Research Involving Human Subjects’. The study is a fragment of the research project of the Department of Children Diseases of Postgraduate Medical Education Faculty, Ivano- Frankivsk National Medical University «Health Status and Adaption of Children from the Precarpathian Region with Somatic Diseases, Their Prevention» 2021-2026, state registration number 0121U111129.Results. On the fi fth day after surgery, the serum CD40-CD40L levels were highest in children who received conventional opioid analgesia. There was no signifi cant diff erence observed between children in the TFPB and TFPB+QLB groups. On the 29th day after surgery, the predicted CD40-CD40L levels were lowest in children who received conventional opioid analgesia combined with the TFPB+QLB.Conclusions. The fi ndings obtained confi rmed the positive eff ect of combined analgesia using opioids and regional nerve block TFPB+QLB in children who received anterior abdominal surgery on suppressing immune mechanisms of pain syndrome involving the CD40-CD40L signaling system.

RENAL DYSFUNCTION IN PRETERM INFANTS WITH PERINATAL PATHOLOGY: RISK FACTORS, SENSITIVITY AND SPECIFICITY OF LABORATORY MARKERS OF DAMAGE

RENAL DYSFUNCTION IN PRETERM INFANTS WITH PERINATAL PATHOLOGY: RISK FACTORS, SENSITIVITY AND SPECIFICITY OF LABORATORY MARKERS OF DAMAGE

Declaration of Helsinki: ethical norm in pursuit of common global goals.

The World Medical Association's Declaration of Helsinki is in the process of being revised. The following amendments are recommended to be incorporated in pursuit of the common goal of promoting health for all. 1. Data-driven research that facilitates broad informed consent and dynamic consent, assuring participant's rights, and the sharing of individual participant data (IPD) and research results to promote open science and generate social value. 2. Risk minimisation in a placebo-controlled study and post-trial access to the best-proven interventions for all who need them. 3. A future-oriented research framework for co-creation with all the relevant stakeholders.

CLINICAL AND LABORATORY ASPECTS IN DIAGNOSTICS OF THE FUNCTIONAL STATE OF THE HEPATOBILIARY SYSTEM IN PRETERM INFANTS

Resume. The insufficient information content of existing methods of diagnosis and treatment, the high incidence of complications, and the growing prevalence of digestive diseases in children in Ukraine justify the necessity for in-depth research in order to deepen understanding of the pathophysiological mechanisms underlying organ pathology with the ultimate goal of improving medical care for newborns.
 The aim of this study is to assess clinical and laboratory parameters characterizing the functional state of the hepatobiliary system in preterm infants.
 Participants and methods. The main group included 68 preterm infants of gestational age 32-33/6 weeks who had clinical signs of severe perinatal pathology; the comparison group involved 27 basically healthy infants of gestational age 34-36/6 weeks. A comprehensive examination of newborns with an assessment of the severity of perinatal pathology and a set of generally accepted biochemical blood parameters was performed. The research was conducted in compliance with the basic provisions of GCP (1996), the Council of Europe Convention on Human Rights and Biomedicine (April 4, 1997), the World Medical Association Declaration of Helsinki on the Ethical Principles of Scientific Medical Research Involving Human Subjects (1964-2008). The research protocol was approved by the Commission on Biomedical Ethics of Bukovinian State Medical University (Protocol No. 5 of 12.09.2015). Statistical processing of the study results was performed using the STATISTICA software (StatSoft Inc., USA, Version 10) MedCalc program (https://www.medcalc. org/index.php). Comparison of quantitative indicators with a normal distribution was performed using the Student's t-test at a statistical significance of p<0.05.
 Results and Discussion. With a burdened somatic history, unfavorable factors of pregnancy and childbirth in the mother, severe forms of diseases in preterm infants in the early neonatal period are accompanied by clinical signs of disorders of the functional state of the hepatobiliary system, in particular, an enlargement of the liver, hepatosplenic syndrome, edema, meteorism, jaundice, hemorrhagic manifestations, such as gastrointestinal bleeding, acholic stools, and hypoglycemia. Laboratory markers of severe functional hepatoniliary disorders include decreased levels of total protein, bilirubin, and glucose; increased levels of urea and cholesterol; reduced enzymatic activity of aspartate aminotransferase and lactate dehydrogenase. A significant decrease in the activity of the enzymes alanine aminotransferase and γ-glutamine transaminase and a decrease in the activity of alkaline phosphatase and Ca2+ level were also observed.
 Conclusions. The obtained results of clinical and laboratory parameters indicate the necessity to study the main pathophysiological syndromes of hepatobiliary system dysfunction in perinatal pathology, considering morphological and functional characteristics in preterm infants.

Daprodustat, a Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor, Improves Hematological Insufficiency without Progression of Myelodysplastic Syndrome with Chronic Kidney Disease

Introduction Hematological insufficiency is a critical issue in the treatment of myelodysplastic syndrome (MDS). The current standard treatment for cytopenia in MDS involves blood transfusion and the administration of erythropoiesis stimulating agents (ESAs). However, ESAs are only effective in certain patients with low erythropoietin levels; patients who are not suitable candidates for allogeneic hematopoietic stem cell transplantation (allo-HSCT) require lifelong blood transfusions. As a result, there is a growing demand for new treatments for cytopenia in MDS, and researchers have been exploring various molecular-targeted drugs in recent years. One promising option is the hypoxia-inducible factor -prolyl hydroxylase inhibitor (HIF-PHi). This inhibitor stabilizes HIF1α, which in turn normalizes endogenous erythropoietin production and iron metabolism, leading to improved renal anemia. It is believed that HIF-PHi could potentially enhance MDS-related anemia by increasing erythropoietin levels. However, despite some case reports, there have been no comprehensive clinical studies evaluating the effectiveness and safety of HIF-PH inhibitors for MDS. Moreover, it is essential to address concerns related to HIF1α overexpression, which has been associated with exacerbating various malignant tumors, including MDS. To assess the safety and effectiveness of HIF-PHi for MDS, we conducted a prospective clinical trial evaluating an oral HIF-PHi called daprodustat. Methods The study included MDS patients with chronic kidney disease (CKD) stage ≥ 3, considering daprodustat's approval in Japan, at Ebina General Hospital. Patients with MDS who were treated with deoxyribonucleic acid methylation inhibitors and/or who underwent allo-HSCT were excluded. Participants were administered daprodustat at the approved dose for renal anemia and underwent regular blood sampling and bone marrow examination. The primary and secondary endpoints were the leukemia rate within 1 year after HIF-PHi administration and hematological improvement (HI), respectively. The study was conducted in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki) and was approved by the Institutional Review Board of the Ebina General Hospital (approval number: JMA-388). Written informed consent was obtained from all participants. Results Seventeen patients with MDS, with a median age of 81years, were included in the analysis. Revised International Prognostic Scoring System scores (IPSS-R) were very low, low, intermediate, high, and very high in 1, 11, 3, 1, and 1 patients, respectively. Five cases were changed from ESA treatment. Within 1 year after HIF-PHi administration, no patients developed leukemia, and both peripheral blood Wilms tumor 1 protein concentrations and bone marrow myeloblast counts remained unchanged from pre-treatment levels. HI was observed in 8 patients within 6 months, and the median dose was 6 (range, 2-12) mg for HI achievement. On univariate analysis, pretreatment transferrin saturation (TSAT, P = 0.002, Figure 1) and ferritin concentration ( P = 0.016) were inversely associated with HI achievement. However, pretreatment hepcidin concentration, erythropoietin concentration, previous ESA use, and IPSS-R were not associated with HI achievement. Notably, when a TSAT cutoff of < 45% was used, achieving HI showed a sensitivity and specificity of 87.5% and 100.0%. Moreover, patients with TSAT < 45% showed significant improvement in anemia after 3 months and beyond (Figure 2). No significant differences were observed in neutrophil and platelet counts between the two groups. Throughout the study, eleven adverse events occurred, including 6 infections, and 1 case each of myocardial infarction, eosinophilia, erythema multiforme, organizing pneumonia, and spinal fracture. Conclusion HIF-PHi administration did not lead to MDS progression. Notably, in MDS patients with CKD, low TSAT was a predictor for achieving HI by HIF-PHi.

CLINICAL AND LABORATORY CHANGES IN POSTSURGICAL PAIN MARKERS IN CHILDREN

Pos toperative pain in children remains a signifi cant problem in pediatric intensive care, possibly related to an imperfectalgorithm for its management. Prolonged postoperative pain delays recovery and rehabilitation, increases treatment costs,and prolongs opioid use. Inadequate perioperative pain management can lead to a variety of postoperative complications, the prediction of which remains elusive despite the use of commonly accepted clinical, laboratory, and instrumental indicators. The aim of this study was to evaluate clinical and laboratory changes in children after abdominal surgery and their correlation with acute pain scales.Material and Methods. The study included 83 children aged 7-18 years who underwent abdominal surgery under opioid anesthesia. Inclusion criteria: age 7-18 years; indication for surgery for acute appendicitis; American Society of Anesthesiologists (ASA) Anesthesia Risk Score I and II; parental consent for the children to participate in the study.Acute pain intensity was measured using the Visual Analog Scale (VAS) and the Face, Legs, Activity, Cry, Consolability(FLACC) scale. Key vital signs assessed included heart rate, respiratory rate, systolic and diastolic blood pressure, and oxygen saturation (SpO2). In addition, laboratory indicators including leukocyte count, blood glucose level, erythrocyte sedimentation rate, and TLR-4 and CD40L levels were determined. All clinical and laboratory studies were conducted in accordance with the World Medical Association Declaration of Helsinki«Ethical Principles for Medical Research Involving Human Subjects» (Minutes of the Ethics Committee No. 2, dated February 24, 2002). Statistical analysis was performed on a personal computer using Statistica 10 software, using parametric and nonparametric statistical methods. The study is a part of the research project of the Department of Children’s Diseases of the Postgraduate Medical Education Faculty of the Ivano- Frankivsk National Medical University «Health Status and Adaptation of Children from the Precarpathian Region with Somatic Diseases, Their Prevention» 2021-2026, state registration number 0121U111129; the author is a co-researcher.Results. The mean age of the children was 13.8±0.23 years, while the mean body weight was 40.9±1.6 kg. Gender assessment showed no diff erences between boys and girls (55.4 % and 44.6 %, respectively, р>0.05).The study showed very strong positive correlations (r=0.9-1.0) between acute pain assessment scores on the VAS and FLACCscale and heart rate, blood glucose levels; strong positive correlations (r=0.7-0. 9) with total leukocyte count and erythrocytesedimentation rate; moderate positive correlations (r=0.5-0.7) with serum TLR4 and CD40L levels; weak positive correlations(r<0.5) with diastolic blood pressure, SpO2, and opioid and non-opioid analgesic administration.Conclusions. The observed positive correlations between acute pain scores on the VAS and FLACC scale and proinflammatory indicators may support the theory of involvement of these markers in the generation of acute pain in pediatricpatients. However, further research is needed to investigate the mechanisms of acute postoperative pain generation, to identify markers related to nociception in chronic pain, and to develop preventive strategies for these conditions in children.

MANAGEMENT OF CHRONIC POSTSURGICAL PAIN AND HYPERALGESIA IN CHILDREN AND ITS INFLUENCE ON COGNITIVE FUNCTIONING

Introduction. Persistent postsurgical pain (PPSP) or chronic postsurgical pain (CPSP) is recognized as a relevantpostoperative complication. Inadequate pain management in the early postoperative period may contribute to the development of hyperalgesia and the use of local anesthetics in regional anesthesia can help in its treatment and prevention.The aim of the study was to study the eff ectiveness of regional analgesia techniques in preventing PPSP and hyperalgesiain children after anterior abdominal wall surgery and to assess quality of life (QoL) using the Cognitive Functioning Scale.Material and Methods. The study included 87 children at the age of 7-18 years who underwent anterior abdominal wallsurgery with diff erent anesthetic techniques. Group I included 27 children who underwent anterior abdominal wall surgery under general anesthesia using the transversalis fascia plane block (TFPB), combined with the quadratus lumborum block 4 (QLB-4). Group II comprised 33 children who underwent anterior abdominal wall surgery under general anesthesia using fentanyl. Group III consisted of 27 children who underwent anterior abdominal wall surgery under general anesthesia using the TFPB. General anesthesia included either inhalation anesthesia or propofol infusion. The control group included 30 healthy children whose cognitive functioning was assessed. All clinical and laboratory studies were conducted in accordance with the World Medical Association Declaration of Helsinki “Ethical Principles for Medical Research Involving Human Subjects”. According to the Law, prior to a subject’s participation in the study, a written informed consent form was signed by each subject (parents/adult guardians). The manuscript was approved by the Ethics Committee of the Communal Non- Profi t Enterprise “Ivano- Frankivsk Regional Children’s Clinical Hospital of Ivano-Frankivsk Regional Council”, as evidenced by an Excerpt from the Minute of the Committee Meeting No. 2 dated February 24, 2022.The results obtained were statistically processed using statistical measures of variation, correlation analysis, Student’s t-test.Diff erences were considered statistically signifi cant at p<0.05. The proportions were statistically compared by a z-test.The study is a fragment of the research project of the Department of Children Diseases of Postgraduate Medical EducationFaculty, Ivano- Frankivsk National Medical University “Health Status and Adaption of Children from the Precarpathian Regionwith Somatic Diseases, Their Prevention” (state registration number 0121U111129; 2021-2026).Results. A signifi cantly higher mechanical pain threshold was observed in children of Group I and Group III both three(226.422.2, 220.318.6, and 182.414.2 g/mm2, respectively, рІ-ІІ<0.05, рІІ-ІІІ<0.05) and six months (288.214.4, 276.414.8,and 174.216.4 g/mm2, respectively, рІ-ІІ<0.05, рІІ-ІІІ<0.05) after surgery.The surface area of hyperalgesia in children of Group I and Group III was signifi cantly smaller as compared to childrenof Group II three (68.69.4, 79.411.4, and 116.814.0 mm2, respectively, рІ-ІІ<0.05, рІІ-ІІІ<0.05) and six months (70.213.0,77.213.2, and 117.212.6 mm2, respectively, рІ-ІІ<0.05, рІІ-ІІІ<0.050) after surgery.The frequency of CPSP was higher in children of Group II (21%) as compared to children in Group I (4%) and Group III(11%). Additionally, assessing chronic pain with the DN4 questionnaire showed its signifi cantly lower level in children of Group Iand Group III as compared to Group II six months after surgery (5.46±0.42, 8.69±0.78, and 13.69±0.38 points, respectively,рІ-ІІ<0.05, рІІ-ІІІ<0.05, рІ-ІІІ<0.05). No statistically signifi cant diff erence in QoL assessment on the Cognitive Functioning Scale was observed on the 7th day following surgery; the QoL scores in all the groups were signifi cantly lower compared to the control group. Three months after surgery, QoL was signifi cantly lower in children of Group II (69.38±6.93 points) as compared to children of Group I (92.08±4.46 points, pІ-ІІ<0.001) and Group III (83.54±4.16 points, pІІ-ІІІ<0.01). Six months following surgery, the lowest QoL was diagnosed in children of Group II (72.08±6.64) as compared to those in Group І (94.17±4.36 points, p<0.001) and Group ІІІ (91.67±4.27, p<0.001).Conclusions.1. The use of general analgesia in combination with regional anesthesia techniques (TFPB or TFPB+QLB) was associatedwith a higher mechanical pain threshold and a smaller area of hyperalgesia around the postoperative wound three and six months after anterior abdominal wall surgery, compared to conventional anesthesia.2. In addition, combined use of regional (TFPB or QLB+TFPB) with general anesthesia demonstrated a lower frequencyof CPSP, a lower level of chronic pain, and a higher level of cognitive functioning in children throughout these time intervals.3. The results obtained provide a foundation for introducing these analgesia techniques (TFPB or TFPB+QLB) in pediatricpatients undergoing anterior abdominal wall surgery, with the aim of mitigating the eff ects of pain syndrome and improving their Qo L.

CLINICAL AND PARACLINICAL FEATURES AND PATHOPHYSIOLOGICAL MECHANISMS OF DIGESTIVE SYSTEM DISORDERS IN PREMATURE INFANTS WITH PERINATAL PATHOLOGY

CLINICAL AND PARACLINICAL FEATURES AND PATHOPHYSIOLOGICAL MECHANISMS OF DIGESTIVE SYSTEM DISORDERS IN PREMATURE INFANTS WITH PERINATAL PATHOLOGY

Psychometric testing of the nurses professional values scale-revised on family and community health nurses.

Family and Community Health Nurses (FCHNs) are at a higher risk of experiencing emotional exhaustion and feelings of low personal accomplishment. Higher levels of professional identity may decrease these negative feelings. Its measurement could produce positive effects for FCHNs and the quality of care they offer. This study aims to evaluate the psychometric properties (validity and reliability) of the Nurses Professional Values Scale-Revised (NPVS-R) on FCHNs in Italy. A cross-sectional research design was used. A convenience sample of FCHNs was recruited in an out-of-hospital setting from Italy. A total of 202 nurses were eligible (mean age of 41.11 ± 10.55years; 78.2% female). The study was performed in accordance with the World Medical Association Declaration of Helsinki. Participants were asked for their consent and were guaranteed anonymity in the information collected. The study was approved by the internal review board of the university. Confirmatory Factor Analysis (CFA) supported a unidimensional factorial structure of the NPVS-R with an adequate fit to the data. Internal consistency reliability was also supported. The construct validity was further reinforced by the concurrent validity results showing a positive and significant correlation of professional identity with job satisfaction. The NPVS-R is a valid and reliable instrument to measure professional identity among FCHNs. It can be used in clinical practice to improve FCHNs' psychological-emotional feelings and quality of care provided, in research to allow comprehensive understanding of professional identity, and in educational settings to monitor the professional identity levels of Family and Community Health Nursing students.

PREVENTION OF HYPERALGESIA IN CHILDREN WHEN USING VARIOUS ANESTHESIA TECHNIQUES

Introduction. Opioid-induced hyperalgesia is characterized by a paradoxical response whereby a patient receiving opioids for pain management could actually become more sensitive to certain painful stimuli. Regional anesthesia can also impact central sensitization and reduce hyperalgesia after surgery.The objective of the study was to determine the method of preventing hyperalgesia in the early postoperative period when using different analgesic regimens in children after anterior abdominal wall surgery.Materials and Methods. The study included 87 children at the age of 7-18 years who underwent anterior abdominal wall surgery using different analgesic techniques. Group I included 33 children who underwent anterior abdominal wall surgery under general anesthesia using fentanyl. Group II comprised 27 children who underwent anterior abdominal wall surgery under general anesthesia using the transversalis fascia plane block (TFPB). Group III involved 27 children who underwent anterior abdominal wall surgery under general anesthesia using the TFPB, combined with the quadratus lumborum block 4 (QLB-4) via a single injection.All clinical and laboratory studies were conducted in accordance with the World Medical Association Declaration of Helsinki “Ethical Principles for Medical Research Involving Human Subjects”. According to the Law, prior to a subject’s participation in the study, a written informed consent form was signed by each subject (parents/adult guardians). The manuscript was approved by the Ethics Committee of the Communal Non-Profit Enterprise “Ivano-Frankivsk Regional Children’s Clinical Hospital of Ivano-Frankivsk Regional Council”, as evidenced by an Excerpt from the Minute of the Committee Meeting No. 2 dated February 24, 2022.The results obtained were statistically processed using statistical measures of variation, correlation analysis, Student’s t-test. Differences were considered statistically significant at p<0.05. The proportions were statistically compared by a z-test.The study is a fragment of the research project of the Department of Children Diseases of Postgraduate Medical Education Faculty, Ivano-Frankivsk National Medical University “Health Status and Adaption of Children from the Pre-Сarpathian Region with Somatic Diseases, Their Prevention” 2021-2026, state registration number 0121U111129; the author is a co-researcher.Results. In most (48.5 %) patients of Group I, the response to stimulation occurred only when applying pressure forces of 8 and 10 g, while the motor response was observed to stimulation with a pressure force of 8 g, with the FLACC scale score of 5.1±0.3, indicating insufficient pain threshold and potential development of opioid-induced hyperalgesia in the early postoperative period. In patients of Group II and Group III, the response to stimulation occurred when applying a pressure force of 8 g and the FLACC scale scores were 2.9±0.27 and 2.4±0.32, respectively (p<0.05).Conclusions. The results obtained confirmed the benefits of using regional anesthesia techniques in combination with conventional analgesia.

A Call to Revise the Declaration of Helsinki's Placebo Guidelines.

Since its introduction in 1964, the World Medical Association's Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects has enshrined the importance of safeguarding the well-being of human subjects in clinical research. The Declaration has undergone seven revisions, often in response to requests for clarification. I want to argue that the Declaration is in need of another revision in light of recent discoveries in placebo research.

Esthesioneuroblastoma: an institutional based descriptive study of a rare tumor

Background: Esthesioneuroblastoma is a slow-growing rare malignant neuroectodermal tumor arising from the olfactory epithelium. It has a bimodal incidence with peaks in the second and third decades of life and the sixth and seventh decades of life with equal incidence among men and women. Prognostic factors include the Hyams grade and modified Kadish stage. This study analyzed the clinicopathological features of esthesioneuroblastoma. Materials and methods- Retrospective study of patients who were diagnosed with esthesioneuroblastoma at a tertiary care hospital between January 2012 and May 2019 was conducted. The research was performed according to the World Medical Association Declaration of Helsinki. Institutional research committee approval (IEC: 473/2019) was obtained. Results: Clinicopathological profiles of 8 patients who were diagnosed with esthesioneuroblastoma during the period were included. Among the eight patients, five were female and three were male. Common presenting complaints were nasal obstruction, difficulty in breathing, epistaxis, local pain, and anosmia. The average age of presentation was 52 years, ranging from 14 to 73 years. Anterior rhinoscopic examination in these cases showed a polypoid mass located in the nasal cavity. According to the Hyams grading system, three of the eight cases were grade-2 and the remaining five cases were grade-3 Hyams histological grade. Three cases exhibited foci of ganglioneuroblastic transformation. Three patients had metastases to cervical lymph nodes and three patients had recurrence. Conclusions: Esthesioneuroblastoma is a rare aggressive malignant tumor. It can exhibit divergent epithelial or ganglionic differentiation. A proper diagnosis should be made, graded and staged before proceeding to treatment.

Amyloid goiter secondary to familial Mediterranean fever with E148Q mutation: A unique case.

Amyloid goiter secondary to familial Mediterranean fever with E148Q mutation: A unique case.

Forced Organ Harvesting

Forced Organ Harvesting

Association of rs11644461 GRIN2A with clinical phenotype of schizophrenia

IntroductionThe glutamatergic system plays an important role in the neurobiology of schizophrenia. A lot of number of variants in the GRIN genes have been found in patients with various neuropsychiatric disorders (Myers et al. F1000Res 2019; 8(F1000 Faculty Rev) 1940). GluN2A, encoded by the GRIN2A gene, is the most abundant of the GluN2 NMDA receptor subunits in the mammalian CNS. Clinical symptoms of schizophrenia vary among individuals. The GRIN2A gene has previously been shown to be associated with early onset schizophrenia (Poltavskaya et al. Life (Basel) 2021; 11(10) 997).ObjectivesThe aim of the study was to identify associations of the GRIN2A gene rs11644461 polymorphism with features of the course of schizophrenia.MethodsThis study was carried out in accordance with the Code of Ethics of the World Medical Association (Declaration of Helsinki 1975). 805 patients with schizophrenia (ICD-10: F20) were included. Clinical examination and diagnostic evaluation were performed using the Positive and Negative Syndrome Scale (PANSS). From the general group of patients, 2 subgroups were distinguished according to the PANSS survey: 391 patients with leading negative symptoms and 414 patients with leading positive symptoms. Also 2 subgroups were distinguished from the general group of patients: 398 patients with a continuous course of schizophrenia and 257 patients with episodic schizophrenia. Genotyping was performed by real-time PCR.ResultsAn association of the C rs11644461 GRIN2A allele with the continuous course of schizophrenia was revealed (p<0,047). The rs11644461 polymorphism was not associated with the leading symptoms of the disease (positive or negative). At the same time, the values of the total score on the PANSS scale differed statistically significantly in carriers of different genotypes for this polymorphism. The sum of PANSS scores (Me [Q25 – Q75]) in carriers of the TC rs11644461 genotype was statistically significantly higher (106 [92–113]) than in carriers of the CC genotype (101 [87–108]) (p=0.006).ConclusionsAccording to the results obtained, carriers of the TC rs11644461 GRIN2A genotype have a higher severity of schizophrenia symptoms according to the PANSS scale than carriers of the CC genotype. Also in the present study, it was shown that the C allele rs11644461 GRIN2A is associated with the continuous course of schizophrenia, which indicates the contribution of this locus to the formation of the course of the disease.Disclosure of InterestE. Poltavskaya Grant / Research support from: Russian Science Foundation # 21-15-00212, O. Fedorenko Grant / Research support from: Russian Science Foundation # 21-15-00212, E. Kornetova Grant / Research support from: Russian Science Foundation # 21-15-00212, I. Pozhidaev Grant / Research support from: Russian Science Foundation # 21-15-00212, D. Paderina Grant / Research support from: Russian Science Foundation # 21-15-00212

Pediatric alopecia areata following COVID‐19 infection

Pediatric alopecia areata following <scp>COVID</scp>‐19 infection

BIOMEDICAL RESEARCH

Biomedical Research encompass basic research to pre-clinical and then clinical research. Both preclinical and clinical research leads to drug development or certain innovations. As increased longevity of humans can be attributed to the advancement of medical research. Clinical Research involve human that include clinical trials. Applied research led to clinical research and it translate into product of research that expands in field of Medicine. But there is still a great need of better understanding of diagnostics and implications of advancement of medical research.&#x0D; Among the major benefits of research are the development of vaccines of different infectious diseases, such as COVID-19, Polio, Measles, TB, Typhoid, and Hepatitis. Development of new surgical techniques as microsurgery have been increasingly successful in treatment of advanced diseases.1&#x0D; Most of Medical Research is going on by Biomedical Scientists but significant discoveries have also been made by other Biologists. Research and publication play a very vital role in progress of sciences in any field.2 But this should always be kept in view that medical research on humans must be strictly followed the medical ethics, that has been found in World Medical Association Declaration of Helsinki.3 Therefore, scientific misconduct should be avoided while conducting biomedical research.

Valuing the individual - evaluating the Dignity Care Intervention.

Palliative care needs in older persons can endanger their dignity. To provide dignity-conserving care to older persons, the Swedish Dignity Care Intervention (DCI-SWE) can be used. The DCI-SWE is built on Chochinov's dignity model and the original version, developed and tested in UK and Scotland. To describe older persons' and their relatives' experiences of dignity and dignity-conserving care when using the DCI-SWE in municipal health care. A mixed method study with convergent parallel design. The DCI-SWE was used and evaluated in a Swedish municipality health care context. Older persons' (n=17) dignity-related distress and quality of life were assessed after the intervention. Interviews with older persons (n=10) and their relatives (n=8) were analysed using thematic analysis. The study followed the World Medical Association Declaration of Helsinki. Ethical approval was obtained from the Regional Ethical Review Board in Uppsala, Sweden (Reg No. 2014/312) and the National Swedish Ethical Review Authority (Reg. No. Ö 10-2019). Informed consent was collected from older persons and their relatives. The older persons' dignity-related distress did not significantly change over time (p = 0.44) neither was their overall quality of life (p = .64). Only psychological quality of life was decreased significantly (p = 0.01). The older persons and their relatives emphasized the importance of valuing the individual. The DCI-SWE provides a forum to talk about dignity issues, but relevant competence, continuity and resources are needed. Psychological care actions and health care professionals' communication skills training are important. To fully evaluate, the DCI-SWE a larger sample and validated instruments are necessary.