Cutaneous Adverse Reactions to TNF Alpha Blockers. Case Report and Literature Review

Biological therapy is used in a wide range of medical settings. Adverse reactions to biological therapy can limit their widespread use, so early detection and treatment can adjust attempts to stop these molecules. TNF Alpha blockers may cause the following skin reactions in alpha patients: injection site reactions, infections, immune-mediated reactions (psoriasis, psoriasis, drug-induced lupus, vasculitis, hidradenitis, alopecia), allergic or neoplastic reactions. We present the case of a patient with RA who developed skin lesions during biological therapy and was diagnosed with drug-induced lupus based on clinical elements, associated autoimmunity, and dermatological evaluation. The skin lesions were attributed to the interaction of three medications (biosimilar Etanercept, Leflunomide, and Isoniazid), all of which have been implicated in causing these side effects. The solutions that saved the patient were temporarily discontinuing the immunosuppressive medication and replacing it with a local corticoid, followed by the continuation of Etanercept in associated with Methotrexate, and the patient was able to continue the biological medication and obtain a favorable response to the treatment. In conclusion, skin changes caused by TNF Alpha inhibitors are common, but vary in severity, and do not warrant therapy interruption

The Prevalence, Management and Impact of Dysmenorrhea on Medical Students’ Lives—A Multicenter Study

Introduction: Dysmenorrhea is defined as the presence of painful menstruation, and it affects daily activities in different ways. The aims of this study were to assess the prevalence and management of dysmenorrhea and to determine the impact of dysmenorrhea on the quality of life of medical students. Material and methods: The study conducted was prospective, analytical and observational and was performed between 7 November 2019 and 30 January 2020 in five university centers from Romania. The data was collected using an original questionnaire regarding menstrual cycles and dysmenorrhea. The information about relationships with family or friends, couples’ relationships and university activity helped to assess the effects of dysmenorrhea on quality of life. The level of significance was set at p < 0.05. Results: The study comprised 1720 students in total. The prevalence of dysmenorrhea was 78.4%. During their menstrual period, most female students felt more agitated or nervous (72.7%), more tired (66.9%), as if they had less energy for daily activities (75.9%) and highly stressed (57.9%), with a normal diet being difficult to achieve (30.0%). University courses (49.4%), social life (34.5%), couples’ relationships (29.6%), as well as relationships with family (21.4%) and friends (15.4%) were also affected, depending on the duration and intensity of the pain. Conclusion: Dysmenorrhea has a high prevalence among medical students and could affect the quality of life of students in several ways. During their menstrual period, most female students feel as if they have less energy for daily activities and exhibit a higher level of stress. The intensity of the symptoms varies considerably and, with it, the degree of discomfort it creates. Most student use both pharmacological and non-pharmacological methods to reduce pain (75.7%). University courses, social life, couples’ relationships, as well as relationships with family and friends are affected, depending on the duration and intensity of the pain

The Outcome of Surgical Treatment for the Neuropathic Diabetic Foot Lesions—A Single-Center Study

The prevalence of diabetic foot complications is continuously increasing as diabetes has become one of the most important “epidemics” of our time. The main objective of this study was to describe the appropriate surgical intervention for the complicated neuropathic diabetic foot; the secondary goal was to find the risk factors associated with minor/major amputation and good or adverse surgical outcomes. This is an observational, retrospective study conducted between 1 January 2018 and 31 December 2019, which included 251 patients from the General Surgery Department at the Dr I. Cantacuzino Clinical Hospital in Bucharest with type II diabetes mellitus and neuropathic diabetic foot complications. The surgical conditions identified at admission were the following: osteitis (38.6%), infected foot ulcer (27.5%), gangrene (20.7%), infected Charcot foot (3.6%), non-healing wound (3.6%), necrosis (3.2%), and granulated wound (2.8%). We found that a minor surgical procedure (transmetatarsal amputation of the toe and debridement) was performed in 85.8% of cases, and only 14.2% needed major amputations. Osteitis was mainly associated with minor surgery (p = 0.001), while the gangrene and the infected Charcot foot were predictable for major amputation, with OR = 2.230, 95% CI (1.024–4.857) and OR = 5.316, 95% CI (1.354–20.877), respectively. Admission anemia and diabetic nephropathy were predictive of a major therapeutical approach, with p = 0.011, OR = 2.975, 95% CI (1.244–8.116) and p = 0.001, OR = 3.565, 95% CI (1.623–7.832), respectively. All the major amputations had a good outcome, while only several minor surgeries were interpreted as the adverse outcome (n = 24). Osteitis (45.8%) and admission anemia (79.2%) were more frequently associated with adverse outcomes, with p = 0.447 and p = 0.054, respectively. The complicated neuropathic diabetic foot requires a surgical procedure mainly associated with a good outcome

Placenta, the Key Witness of COVID-19 Infection in Premature Births

Adverse perinatal outcomes, such as increased risks of pre-eclampsia, miscarriage, premature birth, and stillbirth have been reported in SARS-CoV-2 infection. For a better understanding of COVID-19 complications in pregnancy, histopathological changes in the placenta, which is the interface between mother and foetus, could be the place to look at. The aim of this study was to determine placental histopathological changes and their role in preterm birth in pregnant women with SARS-CoV-2 infection. We performed a prospective, observational study in a COVID-only hospital, which included 39 pregnant women with SARS-CoV-2 infection and preterm birth compared with a control group of 39 women COVID-19 negative with preterm birth and a placental pathology exam available. The microscopic examination of all placentas revealed placental infarction (64.1% vs. 30.8%), decidual arteriopathy (66.7% vs. 23.1%), intervillous thrombi (53.8% vs. 38.5%), perivillous fibrin deposits (59% vs. 46.2%), inflammatory infiltrate (69.2% vs. 46.2%), chorangiosis (17.9% vs. 10.3%), and accelerated maturation of the villi (23.1% vs. 28.2%)

The Prevalence, Management and Impact of Dysmenorrhea on Medical Students&rsquo; Lives&mdash;A Multicenter Study

Introduction: Dysmenorrhea is defined as the presence of painful menstruation, and it affects daily activities in different ways. The aims of this study were to assess the prevalence and management of dysmenorrhea and to determine the impact of dysmenorrhea on the quality of life of medical students. Material and methods: The study conducted was prospective, analytical and observational and was performed between 7 November 2019 and 30 January 2020 in five university centers from Romania. The data was collected using an original questionnaire regarding menstrual cycles and dysmenorrhea. The information about relationships with family or friends, couples&rsquo; relationships and university activity helped to assess the effects of dysmenorrhea on quality of life. The level of significance was set at p &lt; 0.05. Results: The study comprised 1720 students in total. The prevalence of dysmenorrhea was 78.4%. During their menstrual period, most female students felt more agitated or nervous (72.7%), more tired (66.9%), as if they had less energy for daily activities (75.9%) and highly stressed (57.9%), with a normal diet being difficult to achieve (30.0%). University courses (49.4%), social life (34.5%), couples&rsquo; relationships (29.6%), as well as relationships with family (21.4%) and friends (15.4%) were also affected, depending on the duration and intensity of the pain. Conclusion: Dysmenorrhea has a high prevalence among medical students and could affect the quality of life of students in several ways. During their menstrual period, most female students feel as if they have less energy for daily activities and exhibit a higher level of stress. The intensity of the symptoms varies considerably and, with it, the degree of discomfort it creates. Most student use both pharmacological and non-pharmacological methods to reduce pain (75.7%). University courses, social life, couples&rsquo; relationships, as well as relationships with family and friends are affected, depending on the duration and intensity of the pain

Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

Summary: Platform trials bring the promise of making clinical research more efficient and more patient centric. While their use has become more widespread, including their prominent role during the COVID-19 pandemic response, broader adoption of platform trials has been limited by the lack of experience and tools to navigate the critical upfront planning required to launch such collaborative studies. The European Union-Patient-cEntric clinicAl tRial pLatform (EU-PEARL) initiative has produced new methodologies to expand the use of platform trials with an overarching infrastructure and services embedded into Integrated Research Platforms (IRPs), in collaboration with patient representatives and through consultation with U.S. Food and Drug Administration and European Medicines Agency stakeholders. In this narrative review, we discuss the outlook for platform trials in Europe, including challenges related to infrastructure, design, adaptations, data sharing and regulation. Documents derived from the EU-PEARL project, alongside a literature search including PubMed and relevant grey literature (e.g., guidance from regulatory agencies and health technology agencies) were used as sources for a multi-stage collaborative process through which the 10 more important points based on lessons drawn from the EU-PEARL project were developed and summarised as guidance for the setup of platform trials. We conclude that early involvement of critical stakeholder such as regulatory agencies or patients are critical steps in the implementation and later acceptance of platform trials. Addressing these gaps will be critical for attaining the full potential of platform trials for patients. Funding: Innovative Medicines Initiative 2 Joint Undertaking with support from the European Union’s Horizon 2020 research and innovation programme and EFPIA