Minor Side Effects Research Articles

Myocardial Safety Following COVID-19 Vaccination

Abstract Background and Aim Vaccination is a well-established part of preventive and public health medicine, but is not without risk. COVID-19 vaccination frequently leads to minor side-effects, for example pain, swelling and redness at the site of injection, and systemic symptoms of fatigue, headache, muscle pain, chills and fever; side effects after the second dose may be more intense than the first dose. Among the vaccines, more serious side effects have been reported, including myocarditis. This study was aimed to detect any evidence of myocardial damage after COVID-19 vaccination. Subjects and methods We selected 150 subjects (both sexes) randomized into two groups as 75 patients who are fully vaccinated with AstraZeneca vaccine (two doses) the study was conducted at least after two weeks from the second dose of the vaccine and 75 patients who are not vaccinated. Results This study was carried on 150 patients, 52 (34.7%) of whom were females, and 98 (65.3%) were males. The mean age of the studied group was (34 years old). The LVEDV (indexed) mean of 45.08 ml/m2 in the cases group and 43.8 ml/m2 in the control group. The EF mean of 63.2% in the cases group and 62.9% in the control group. And the GLS median of -19% in the cases group and -19% in the control group. Conclusion COVID-19 vaccination has no evidence association of any myocardial damage. Nevertheless, the advantages of these vaccines for ending the pandemic and/or decreasing the mortality rate outweigh any risk for the rare cardiovascular complications.

Acupoint Application Combined with Acupoint Massage for Treating Constipation in a Patient with Chronic Obstructive Pulmonary Disease.

Chronic obstructive pulmonary disease (COPD) is a common and frequent disease in elderly patients, with a tendency for progressive exacerbation. Constipation that reduces the quality of life and triggers the risk of diseases is a common concomitant symptom in patients with COPD. Currently, western medical treatment does not achieve the desired results for patients. A high recurrence rate accompanies it, whereas traditional Chinese medicine (TCM) has a long history and rich experience in treating chronic diseases. Both acupoint application and acupoint massage are characteristic therapies of TCM, with minor side effects, high safety, simple operation, and outstanding advantages. They are effective in treating constipation for patients with COPD and are considered an ideal alternative therapy for patients with chronic constipation. The purpose of this article is to introduce the method of acupoint application combined with acupoint massage for the treatment of constipation in patients with COPD, including the selection of points, items, treatment time, and operation procedure.

Dietary Polysaccharides Exert Anti-Fatigue Functions via the Gut-Muscle Axis: Advances and Prospectives.

Due to today's fast-paced lifestyle, most people are in a state of sub-health and face "unexplained fatigue", which can seriously affect their health, work efficiency, and quality of life. Fatigue is also a common symptom of several serious diseases such as Parkinson's, Alzheimer's, cancer, etc. However, the contributing mechanisms are not clear, and there are currently no official recommendations for the treatment of fatigue. Some dietary polysaccharides are often used as health care supplements; these have been reported to have specific anti-fatigue effects, with minor side effects and rich pharmacological activities. Dietary polysaccharides can be activated during food processing or during gastrointestinal transit, exerting unique effects. This review aims to comprehensively summarize and evaluate the latest advances in the biological processes of exercise-induced fatigue, to understand dietary polysaccharides and their possible molecular mechanisms in alleviating exercise-induced fatigue, and to systematically elaborate the roles of gut microbiota and the gut-muscle axis in this process. From the perspective of the gut-muscle axis, investigating the relationship between polysaccharides and fatigue will enhance our understanding of fatigue and may lead to a significant breakthrough regarding the molecular mechanism of fatigue. This paper will provide new perspectives for further research into the use of polysaccharides in food science and food nutrition, which could help develop potential anti-fatigue agents and open up novel therapies for sub-health conditions.

Tissue-preserving treatment with non-invasive physical plasma of cervical intraepithelial neoplasia-a prospective controlled clinical trial.

ObjectiveCervical cancer represents the fourth leading cause of cancer among women and is associated with over 311,000 annual deaths worldwide. Timely diagnosis is crucial given the lengthy pre-cancerous phase, which is typified by cervical intraepithelial neoplastic lesions. However, current treatment methods are often tissue-destructive and can be accompanied by severe side effects. To address these concerns, our study introduces a novel, gentle approach for the tissue-preserving treatment of CIN lesions.ResultsWe present findings of a controlled, prospective, single-armed phase IIb clinical trial performed at the Department for Women’s Health, Tübingen, Germany. From September 2017 to March 2022 we assessed 570 participants for study eligibility. Of the screened patients, 63 participants met with CIN1/2 lesions met the inclusion criteria and were treated with non-invasive physical plasma (NIPP). Assessment of treatment efficacy was based on a comprehensive analysis of histological and cytological findings, along with high-risk HPV infection load at 3 and 6 months post-treatment. Comparative analyses were performed retrospectively with data obtained from 287 untreated patients in the control group. Our findings indicate that patients treated with NIPP experienced an 86.2% rate of full remission, along with a 3.4% rate of partial remission of CIN lesions, which compares favorably to the control group’s rates of 40.4% and 4.5%, respectively. Additionally, we observed a twofold reduction in high-risk HPV infections following NIPP treatment. Minor side effects were observed, such as mild pain during treatment and short-term smear bleeding or increased vaginal discharge within 24 h after treatment. Given the experimental nature of NIPP treatment and the availability of established standard treatments, our study was designed as a non-randomized study.ConclusionNIPP treatment offers a highly flexible and easy-to-apply method for treating pre-cancerous CIN1/2 lesions. This non-invasive approach is notable for its tissue-preserving nature, making it a promising alternative to current excisional and ablative treatments. CIN1/2 lesions were employed as preliminary in vivo models for the targeted treatment of CIN3 lesions.Clinical trial registrationhttps://www.clinicaltrials.gov, identifier NCT03218436.

Desirability of Outcome Ranking for Status Epilepticus: A Benefit-Risk Approach to Design and Analyses of Clinical SE Trials.

Most clinical trials of treatment efficacy evaluate benefits and harms separately. Investigators generally rate the primary outcome of a trial with a binary outcome measure and consider harms separately as adverse events. This approach fails to recognize finer gradations of patient response, correlations between benefits and harms, and the overall effects on individual patients. For example, in status epilepticus trials, efficacy is often defined as the absence of clinically apparent seizures with recovery of consciousness. Such an efficacy outcome fails to recognize that some causes of status epilepticus, such as subarachnoid hemorrhage or stroke, may not be accompanied by return of consciousness, and the need to intubate a patient may be classified as treatment failure even if status was successfully terminated. The Desirability of Outcome Ranking (DOOR) method uses a different approach. The DOOR method involves comparing the experiences of trial participants in different treatment arms by the desirability of the overall patient outcome. Using status epilepticus treatment as an example, a patient who experiences successful termination of status epilepticus but with major side effects would have a less desirable outcome than a patient with treatment success and minor side effects, who in turn would have a less desirable outcome than a patient with treatment success but no side effects. This is a patient-centered approach because it considers treatment efficacy in the context of the costs borne by the patient, for example, toxicity in achieving efficacy. Thus, DOOR considers both the benefits and harms to individual patients in assessing the outcome of a clinical trial. In this article, we present the rationale for the use of DOOR, the issues involved in the development of and statistical analyses of an ordinal outcome, and an example of the potential application of the DOOR method to a clinical trial of convulsive status epilepticus.

Refractory Pseudomonas aeruginosa infections treated with phage PASA16: A compassionate use case series

A growing number of compassionate phage therapy cases were reported in the last decade, with a limited number of clinical trials conducted and few unsuccessful clinical trials reported. There is only a little evidence on the role of phages in refractory infections. Our objective here was to present the largest compassionate-use single-organism/phage case series in 16 patients with non-resolving Pseudomonas aeruginosa infections. We summarized clinical phage microbiology susceptibility data, administration protocol, clinical data, and outcomes of all cases treated with PASA16 phage. In all intravenous phage administrations, PASA16 phage was manufactured and provided pro bono by Adaptive Phage Therapeutics. PASA16 was administered intravenously, locally to infection site, or by topical use to 16 patients, with data available for 15 patients, mainly with osteoarticular and foreign-device-associated infections. A few minor side effects were noted, including elevated liver function enzymes and a transient reduction in white blood cell count. Good clinical outcome was documented in 13 out of 15 patients (86.6%). Two clinical failures were reported. The minimum therapy duration was 8days with a once- to twice-daily regimen. PASA16 with antibiotics was found to be relatively successful in patients for whom traditional treatment approaches have failed previously. Such pre-phase-1 cohorts can outline potential clinical protocols and facilitate the design of future trials. The study was funded in part by The Israeli Science Foundation IPMP (ISF_1349/20), Rosetrees Trust (A2232), United States-Israel Binational Science Foundation (2017123), and the Milgrom Family Support Program.

Musculoskeletal corticosteroid injection and risk of acute coronary syndrome: a case control study.

Musculoskeletal corticosteroid injection (CSI) is a frequently used treatment, considered safe with a low incidence of minor side effects. To investigate whether the incidence of acute coronary syndrome (ACS) is increased following corticosteroid injection for musculoskeletal conditions. Data were reviewed from 41,276 patients aged over 40 years and hospitalised with ACS between January 2015 and December 2019. Each ACS case was allocated up to 10 control patients from their primary care clinic, matched for age and sex. The cases and controls were reviewed for orthopaedic or rheumatological consultation including a CSI procedure and occurring prior to the hospital admission date. The incidence of CSI was compared between the case and control groups. Data from a total of 413,063 patients were reviewed, 41,276 ACS cases and 371,787 controls. The mean age was 68.1, standard deviation (SD) = 13.1, 69.4% male. In the week prior to their hospital admission, 118 ACS patients were treated with CSI compared with 495 patients in the control group; odds ratio (OR) = 1.95 (1.56-2.43). In total, 98% of CSI procedures were carried out by orthopaedic specialists. An association between ACS and prior CSI was strongest in the days immediately prior to hospitalisation: OR = 3.11 (2.10-4.61) for patients who were injected 1 day before ACS. The association between ACS and CSI declined with increasing time between injection and hospital admission: at 90 days OR = 1.08 (0.98-1.18). The association remained robust when cardiovascular risk factors, history of rheumatological disease, and other co-morbidity were taken into consideration. Musculoskeletal corticosteroid injection appears to substantially increase the risk of acute coronary syndrome.

Factors affecting Naseptin treatment success - A prospective cohort study.

To assess patient factors to predict treatment success of Naseptin for recurrent paediatric epistaxis. This prospective cohort study of paediatric patients referred to a tertiary paediatric otolaryngology clinic with recurrent epistaxis treated with Naseptin cream and education. Patients with red flag symptoms and bleeding diathesis were omitted, along with patients with concurrent otolaryngology complaints. Statistical analysis included logistic regression analysis to assess for predictive factors contributing to treatment success. 125 of 210 patients on the waiting list met the inclusion criteria and were given a complete trial of Naseptin. 80.8% (n=101) of patients found that the frequency and severity of epistaxis had reduced, with the remaining 19.2% (n=24) reporting that the episodes of epistaxis remained the same and required further management (i.e., silver nitrate cautery). Five patients (4%) reported minor side effects (skin irritation etc.) with no significant adverse events reported. We found that Naseptin is a safe, well-tolerated treatment that should be trialled in most cases of recurrent paediatric epistaxis. Most children will benefit from it with complete epistaxis cessation or at least reduced frequency and severity.

Caenorhabditis elegans as an In Vivo Model for the Discovery and Development of Natural Plant-Based Antimicrobial Compounds.

Antimicrobial resistance (AMR) due to the prevalence of multidrug-resistant (MDR) pathogens is rapidly increasing worldwide, and the identification of new antimicrobial agents with innovative mechanisms of action is urgently required. Medicinal plants that have been utilised for centuries with minor side effects may hold great promise as sources of effective antimicrobial products. The free-living nematode Caenorhabditis elegans (C. elegans) is an excellent live infection model for the discovery and development of new antimicrobial compounds. However, while C. elegans has widely been utilised to explore the effectiveness and toxicity of synthetic antibiotics, it has not been used to a comparable extent for the analysis of natural products. By screening the PubMed database, we identified articles reporting the use of the C. elegans model for the identification of natural products endowed with antibacterial and antifungal potential, and we critically analysed their results. The studies discussed here provide important information regarding "in vivo" antimicrobial effectiveness and toxicity of natural products, as evaluated prior to testing in conventional vertebrate models, thereby supporting the relevance of C. elegans as a highly proficient model for their identification and functional assessment. However, their critical evaluation also underlines that the characterisation of active phytochemicals and of their chemical structure, and the unravelling of their mechanisms of action represent decisive challenges for future research in this area.

Design and Development of Matrix Diffusion Control Transdermal Drug Delivery System for Antiemetic Drug

Delivery of drugs into the systemic circulation via transdermal drug delivery system is well known. Transdermal drug delivery system is one of the most reliable and convenient delivery system for the delivery across skin. The aim of this research project is to develop a matrix diffusion control transdermal therapeutic system that combines the drug Ramosetron hydrochloride with an amount of hydrophilic and hydrophobic polymers using a solvent extraction method. Ramosetron hydrochloride is a highly potent drug and has an extended duration of action ad minor side effects despite the severity that it undergoes hepatic pass metabolism and therefore the purpose of this study was to prepare a transdermal patch for Ramosetron hydrochloride for the treatment of chemotherapy induced nausea and vomiting (Anti-emetic action) and evaluate it for various parameters.

Azathioprine monotherapy withdrawal in inflammatory bowel diseases: A retrospective mono-centric study.

There is no consensus on the recommended duration of and optimal time to stop azathioprine (AZA) therapy in inflammatory bowel disease (IBD). Determining the optimal duration and cessation time can help to balance the risks of long-term intake with the possibility of relapse after cessation. To describe the events following AZA cessation. Retrospective analysis was performed to examine data from adult patients affected by IBD who were followed at the University of Padua and had started but then discontinued AZA between 1995 and 2022. Data on therapy duration, reasons for cessation, and type of relapse after cessation were collected. Cox regression models were used to estimate the risk of relapse in different subgroups. A total of 133 ulcerative colitis patients and 141 Crohn's disease patients were included. Therapy with AZA was stopped in the 1st year in approximately 34% of patients but was continued for more than 10 years in approximately 10% of cases. AZA discontinuation was due to primary failure or disease relapse in 30% of patients and due to disease remission in 25.2% of patients. Most of the remaining cases stopped AZA therapy due to side effects (primarily clinical intolerance, cytopenia, and pancreatic disease). Patients who stopped AZA for clinical remission had an 83% lower risk of relapse during the observation time than other groups, with a relapse-free rate of 89% after 1 year and 79% after 2 years. AZA administration is effective and safe, but it requires careful monitoring for potential minor and major side effects. Only 10% of patients who achieved remission with AZA needed a new treatment within 1 year of drug interruption.

Hydroxyurea treatment for adult sickle cell anemia patients in Kinshasa.

Background: Despite a high incidence of sickle cell anemia, hydroxyurea (HU) treatment is rarely used in the DR Congo. This study aims to assess the efficacy of HU, the incidence of side effects that may limit its use in adults and to determine the dose needed for clinical improvement in patients. Methods: In a prospective study, patients received an initial dose of 15mg/kg/day which was increased by 5mg/kg every 6 months, up to a maximum of 30mg/kg/day. The response and side effects to HU were evaluated biologically and clinically every 3 months during a 2-year period. Results: Seventy adult patients with a moderate or severe clinical phenotype initiated treatment. Only minor side effects were reported. At the end of the 2-year treatment phase, 45 (64.3%) had dropped out, of whom 33 were without a clear reason. Clinical and biological improvement was more marked during the first year. There was a reduction in severe vaso-occlusive crises (p<0.001), need for transfusion (p<0.001), and hospitalization days (p=0.038). Fetal hemoglobin (HbF) levels increased on average 2.9 times after 12 months (p<0.001). The increase in mean corpuscular volume was greater in the first year (p<0.001) than in the second year (p=0.041). The decrease in leukocytes (p<0.001) was significant during the first year. In 70% of patients, the 20mg/kg/day dose was needed to reach the 20% HbF threshold. Conclusion: HU is effective and well tolerated. The magnitude of the response varies from one patient to another. Improvement of clinical manifestations is achieved in most patients with a relatively low dose. Effective implementation of HU treatment will require improved adherence to treatment.

Digestive α-L-fucosidase activity in Rhodnius prolixus after blood feeding: effect of secretagogue and nutritional stimuli.

Introduction: Rhodnius prolixus (Hemiptera: Reduviidae) is an important vector of Trypanosoma cruzi, the causative agent of Chagas Disease. This insect is a model for the study of insect physiology, especially concerning the digestion of blood. Among the enzymes produced in the midgut of R. prolixus after blood feeding there is a α-L-fucosidase activity. There are very few studies on α-L-fucosidase of insects, and the role of R. prolixus α-L-fucosidase is still not clear. In this work, we tested if the mechanism for production of this enzyme is similar to the observed for proteases, a secretatogue mechanism that respond to the protein contents of the meal. Methods: We tested if specific proteins or sugars elicit this response, which may help to understand the nature of the physiological substrate for this enzyme. Results: In general, our results showed that the Anterior Midgut was the only midgut fraction that responds to the blood meal in terms of α-L-fucosidase production. Besides that, this response was not triggered by midgut distension or by ingestion of the blood cell fraction. Conversely, the enzyme was produced after feeding with the plasma fraction. However, the production of α-L-fucosidase was also triggered by different biochemical stimuli, as protein or fucoidan ingestion. Discussion: This suggested that the production of the enzyme in the anterior midgut was a general physiological response under control of different convergent signals. Besides that, the comparison between different treatments for artificial blood feeding showed that heparinated blood was the choice with minor side effects for the study of the midgut α-L-fucosidase, when compared to defibrinated or citrated blood.

Global Facial Rejuvenation Using a New Cohesive, Highly Concentrated Hyaluronic Acid Filler: A Descriptive Analysis of 35 Cases

Cosmetic procedures using fillers have gained importance over the last decades due to their ability to offer rejuvenation and beautification quickly with no (or minor) side effects. Hyaluronic acid (HA) gel is the most used filler in cosmetic dermatology; its physical and chemical properties vary according to the manufacturing process. The characteristics of the final product are crucial for its clinical indication. Specific physicochemical properties of HA gel are required to fill, volumize, sustain, and contour different anatomical areas and layers. Ideally, HA gels should have a consistency similar to that of the surrounding tissue to promote a natural feel, but, at the same time, they should be able to sustain their shape against constant physical strain caused by muscle contraction during mimic movements. Generally, softer gels are indicated to fill superficial layers, and are not usually meant to perform lifting or volumizing, for which stiffer gels are proposed. Therefore, combining gels with different characteristics is indicated for global facial treatment. The Brazilian market recently introduced a new Korean HA filler. Still, clinical evaluation of global facial treatment using these products is lacking in the literature. This study aims to describe clinical results, patient satisfaction, and side effects of facial treatment using these fillers. We analysed the clinical impact of global facial treatment in 35 patients performed by seven dermatologists. Patients of both sexes desiring beautification or rejuvenation were included, and all of them had indications for the filling procedure. Three Korean HA gels (e.p.t.q. S100, S300, and S500, Jetema ®) with high HA concentrations and cohesiveness, varying only in their crosslinking degree, were used. The dermatologists chose the product for each procedure based on their rheological properties and clinical assessment. S100 gel was indicated for refinement, and S300 and S500 gels for structure and volume. The doctors evaluated the clinical outcomes of rejuvenation or beautification using the Global Aesthetic Improvement Scale (GAIS), and patient satisfaction using the Likert scale, 1, 3, and 6 months after the procedures. Patients treated included 4 males and 31 females with a mean age of 43.08 years. An average of 6.33 syringes was used. After 30 days, 80% of patients showed excellent or accentuated improvement, with 94.2% satisfaction. After 3 and 6 months, 80% of patients showed excellent or accentuated improvement, which increased their happiness (97%). Immediate common side effects occurred in 17 patients. One patient had a vascular occlusion, which was quickly reverted using hyaluronidase. Most patients had accentuated improvement and great satisfaction. This new cohesive, highly concentrated HA gel promoted a sustained global improvement and patient satisfaction with expected transitory side effects.

Eucryphin analog's total synthesis, anti-inflammatory activity for DNFB-induced contact hypersensitivity and structure-activity relationship

Eucryphin, a natural product widely found in plants, has a variety of biological activities. In this work, a series of eucryphin analogs were designed, synthesized, characterized and the anti-inflammatory activity in vivo was evaluated comparing with eucryphin and its 7-O-glycosyl derivatives to study the structure-activity relationship. Eucryphin exhibited remarkable anti-inflammatory activity and minor side effects in 2,4-dinitrofluorobenzene (DNFB) induced mice auricle edema model. Glycosyl substitution at the position of C-3 was essential for the anti-inflammatory activity. Methyl substitution at C-2 and glycosylation at C-7 of eucryphin reduce anti-inflammatory activity.

Review of the Role of Nanotechnology in Overcoming the Challenges Faced in Oral Cancer Diagnosis and Treatment.

Throughout the world, oral cancer is a common and aggressive malignancy with a high risk of morbidity, mortality, and recurrence. The importance of early detection in cancer prevention and disease treatment cannot be overstated. Conventional therapeutic strategies have minor difficulties but considerable side effects and unfavourable consequences in clinical applications. Hence, there is a requirement for effective ways for early detection and treatment of oral cancer. At present, numerous forms of nanoparticles have piqued researchers' interest as a potentially useful tool for diagnostic probes and medicinal devices. Because of their inherent physicochemical properties and customizable surface modification, they are able to circumvent some of restrictions and accomplish the intended diagnostic and therapeutic impact. Nanotechnology is a unique field that has revolutionised the industry and is paving the way for new treatments for oral cancer. It can help with a better diagnosis with less harmful substances and is setting current guidelines for treatment. The use of nanotechnology in cancer diagnosis, therapy, and care improves clinical practise dramatically. The different types of nanoparticles that have been developed for the diagnosis and therapy of oral cancers will be covered in this study. The difficulties and potential uses of nanoparticles in the treatment and diagnosis of oral cancer are then highlighted. In order to emphasise existing difficulties and potential remedies for oral cancer, a prospective view of the future is also provided.

Brief literature review and comprehensive bioinformatics analytics unravel the potential mechanism of curcumin in the treatment of periodontitis

ObjectivePeriodontitis is a chronic oral disease prevalent worldwide, and natural products are recommended as adjunctive therapy due to their minor side effects. Curcumin, a widely used ancient compound, has been reported to possess therapeutic effects in periodontitis. However, the exact mechanism underlying its activity remains unclear. In this context, the present study aimed to conduct computational simulations to uncover the potential mechanism of action of Curcumin in the treatment of periodontitis.Materials and methodsSingle-cell analysis was conducted using a dataset (i.e., GSE164241) curated from the Gene Expression Omnibus (GEO) database through an R package "Seurat package." Bulk RNA sequencing data were curated from GSE10334 and GSE16134 and processed by R package "Limma." Then, the marker genes in the single-cell transcriptome and differentially expressed genes (DEGs) in the bulk transcriptome were integrated. Kyoto Encyclopedia of Genes and Genomes (KEGG) and Gene Ontology (GO) analyses were also carried out to reveal their functionalities. Key targets were mined from their protein–protein interaction (PPI) network topologically. Afterward, molecular docking was performed. The top-ranked pose was subjected to molecular dynamics simulations to investigate the stability of the docking result.ResultsFOS, CXCL1, CXCL8, and IL1B, were filtered after a series of selected processes. The results of molecular modeling suggested that except for IL1B, the Vena Scores of the rest exceeded -5 kcal/mol. Furthermore, the molecular dynamic simulation indicated that the binding of the CXCL8-Curcumin complex was stable over the entire 100 ns simulation.ConclusionThe present study unlocked the binding modes of CXCL1, FOS, and CXCL8 with the Curcumin molecule, which were relatively stable, especially for CXCL8, hindering its promising potential to serve as the critical targets of Curcumin in periodontitis treatment.

ФИТОТЕРАПИЯ В РЕАБИЛИТАЦИИ ЛЕГКИХ И УМЕРЕННЫХ КОГНИТИВНЫХ РАССТРОЙСТВ

An increase in life expectancy creates prerequisites for the appearance of more patients with cognitive impairments. Early diagnosis, treatment and rehabilitation of cognitive disorders improves the quality of life of patients, prevents the development of dementia, and is of great social importance. Herbal medicines are highly effective in the treatment of mild and moderate cognitive impairment, affect various links of pathogenesis, have minor side effects. The most effective of them are: galantamine from snowdrop tubers; hyperzine from sawtooth grass; ginkgo two-lobed flavanoids; biologically active substances of medicinal sage and periwinkle.

Novoglan device for treatment of adult phimosis: Novoglan-01 open-label clinical trial on safety, efficacy and tolerability.

At present, the only definitive treatment for adult phimosis is circumcision, which is a surgical removal of the prepuce. Novoglan is a novel device that could offer patients with phimosis an alternative to surgery. It is based on application of custom-moulded balloons for gradual skin remodelling and prepuce dilatation. This open-label clinical trial aimed to investigate the safety, efficacy and tolerability of the Novoglan treatment. A prospective trial was conducted on 20 patients with adult phimosis recruited at Macquarie University Hospital and Princess Alexandra Hospital. After eligibility screening and enrolment, patients were provided with the Novoglan product and training. The treatment involved twice daily 10-minute applications for a duration of 4-8 weeks with patient's degree of phimosis assessed before and at 6-8 weeks after the initiation of the treatment. Participants were also asked to complete questionnaires aimed to assess the safety and tolerability of the Novoglan treatment. The treatment was successful with improved foreskin retraction in 90% of patients and all patients achieving full foreskin retraction after the treatment. Ninety-five percent of patients reported reduced level of anxiety, and over 60% of patients reported reduced pain/discomfort during sexual activity or in general. Similarly, 95% of patients were moderately-to-very satisfied with the treatment and would recommend Novoglan to others. No adverse events were observed and only 15% of participants reported minor side effects. The Novoglan-01 trial demonstrated high safety, efficacy and tolerability of the Novoglan treatment for adult phimosis and its high potential as a conservative alternative to circumcision or steroid cream treatment. The Novoglan-01 study has been registered with the Australia and New Zealand Clinical Trial Registry under the reference ACTRN 1262 10009 24853, dated 15 July 2021.

Safety Profile of Methotrexate in Patients with Rheumatoid Arthritis

Background: Methotrexate (MTX) is recommended as first-line therapy in patients with active Rheumatoid Arthritis (RA) as monotherapy or in combination with other disease-modifying anti-rheumatic drugs (DMARDs). Despite being considered a safe drug, some toxicities of MTX are inevitable and patients discontinue further treatment with MTX for the same.&#x0D; Objective: To evaluate the safety profile of Methotrexate in patients with RA.&#x0D; Methodology: An observational cross sectional study was conducted at a tertiary care hospital from 1st January 2020 to 31st December 2020 at rheumatology OPD in department of medicine, KLES, Dr. Prabhakar Kore Hospital, Belagavi. 117 patients diagnosed with RA who had been undergoing methotrexate treatment for at least six months as monotherapy or in combination with other DMARDs were included. Patient demographics, disease and treatment characteristics, side effects, and blood and laboratory markers specific to RA were studied with regards to methotrexate. Continuous variables were presented as mean and standard deviation, while categorical variables were presented as frequency and percentage. Association between categorical variables was done using Fisher exact test and chi square test.&#x0D; Results: The study predominantly consisted of females (85.5%), and the mean age of patients was 47.92±13.398 years. Patient-reported side effects were seen/observed in 47% of patients. Commonly reported minor side effects were fatigue (17.1%), nausea (16.2%), anorexia (11.1%), stomatitis/oral ulcers (10.3%), epigastric burning (8.5%), hair fall (3.4%), and vomiting in 0.9% of patients. Demographic and clinical factors were not associated with side effects. There was no significant association between side effects and type of treatment.&#x0D; Conclusion: Use of methotrexate in combination with other DMARDs is safe and should be encouraged as first line treatment of RA on routine basis. However, periodic blood and laboratory monitoring along with patient follow-ups are essential for early detection of toxicities.