Current Medicine

Overview of Phase IV Clinical Trials Targeting COVID-19: Status Report of Studies Registered on the ClinicalTrials.gov Platform

Renato Ferreira- da-Silva, João Miguel Alves — Mon, 31 Jan 2022 00:00:00 +0000

Introduction: Phase IV trials evaluate drugs' efficacy, safety, and tolerability in a real-world setting, which may provide evidence related to the safety of approved drugs. This study aimed to characterize the phase IV clinical trials registered at ClinicalTrials.gov targeting COVID-19 and reflect on future needs for post-marketing clinical trials.
Methods: A descriptive cross-sectional study was performed in the ClinitalTrials.gov database with phase IV clinical trials addressed to COVID-19. The search was carried out on March 23rd, 2021, considering search filters for this disease.
Results: A total of 146 protocols were retrieved through a structured search. The results showed the need to promote new, blinded, and larger sample-size phase IV clinical trials. 93.9% of the clinical trials were funded by individuals, universities, and organizations (category "other" funders), and 56.8% were open-label. America and Europe played a more critical role in phase IV clinical trials, with the former leading with 58 trials spread across five countries and the latter with 38 trials in 17 countries. More than two-thirds of the trials (69.8%) included 500 participants.
Conclusions: For the observed period, phase IV clinical trials registered in the ClinicalTrials.gov were dominated by short-term follow-up, open-label designs, small sample sizes, funded mainly by individuals, universities, and organizations, and centered mainly in America and Europe. The methodological features of future studies should be emphasized, namely adequate sample sizes, for which appropriate funding for the implementation of these studies is paramount.

Utility of Procalcitonin as a Diagnostic Tool for Sepsis in Intensive Care Units

Salam Bennouar, Abdelghani Bachir Cherif , Samia Abdi — Wed, 30 Mar 2022 00:00:00 +0000

Introduction/Objective: Sepsis is one of the leading causes of mortality in the intensive care unit (ICU). Its diagnosis is often complex and represents a real clinical challenge. The objective of this study was to evaluate the usefulness of procalcitonin (PCT) as a diagnostic marker of sepsis.
Methods: This prospective cohort study included 65 patients hospitalized in the ICU. Demographic and clinical data were collected according to a specific information sheet. All patients underwent an inflammatory assessment including PCT, hypersensitive C - reactive protein (hsCRP), and complete blood count. The Sequential Organ Failure Assessment (SOFA) score was calculated. Patients were classified into septic (SOFA ≥ 2 points) and non-septic (SOFA < 2 points). The Receiver Operating Characteristic (ROC) curve was used to evaluate the diagnostic performance of inflammatory parameters.
Results: Of 65 included patients, 46 had developed sepsis. Among the investigated inflammatory markers, PCT has the best discriminative capacity; its area under the curve (AUC), of 0.78, was the highest, followed by the neutrophils to lymphocytes ratio (NLR) and hsCRP with a lower but statically significant AUC. The optimal PCT threshold for sepsis diagnosis was 4.5ng/ml with a specificity of 83% and a sensitivity of 60%. A positive correlation between the PCT levels and the SOFA score was also found (p=0.002).
Conclusion: This study provides additional evidence of the performance of PCT in the diagnosis of septic states in patients admitted to ICU. The newly established cut-off value provides the best balance between specificity and sensitivity. Its superiority over conventional inflammatory markers has been demonstrated.

Associations between Lifestyle Medicine Activities and Type 1 Diabetes Mellitus Management: A Systematical Review

Fri, 05 Aug 2022 00:00:00 +0000

According to the Brazilian Society of Diabetes, the prevalence of Type 1 Diabetes Mellitus (T1DM) is increasing; thus, alternative and pharmacological measures are required to manage and control the disease. Many studies discussed lifestyle medicine with Type 2 Diabetes Mellitus (T2DM). However, studies on the pillars of lifestyle medicine with T1DM are limited. The lack of research on the subject prompted the development of this systematic review. We aimed to evaluate the association between lifestyle medicine activities and delay in the clinical manifestations of T1DM. We included randomized and nonrandomized clinical trials and retrospective or prospective longitudinal studies. English, Portuguese and Spanish were screened as accepted languages. Participants could be of any geographic location or sex. Regarding the interventions, we selected diet, exercise, sleep, stress reduction, and smoking cessation as lifestyle medicine practices with a possible association with glycemic control improvement in patients with T1DM. In total, 22,552 publications have been identified; at the end, 28 articles, 11 clinical trials, and 17 cohorts were selected, involving 16.627 patients and 14 countries. Although lifestyle modifications seem to have the potential to alter the course of T1DM in many ways, the evidence available to date is insufficient.

Therapeutic use of Mesenchymal Stem Cells against SARS-Cov-2: Present and Future prospects

Tue, 16 Aug 2022 00:00:00 +0000

The Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) outbreak, also known as COVID-19, from the seafood market in Wuhan, China, has the world on its knees within a short time, impacting health infrastructure, economy, science, and most importantly human existence. On March 11, 2020, the World Health Organization (WHO) declared COVID-19 a pandemic. Since the first encounter with COVID-19, the medical fraternity has been exploring various ways to counter the disease and related complications. Attempts have also been made to prevent infection by developing vaccines to reduce the severity of the disease and mortality postinfection. However, even as the first peak of the epidemic (also known as the “first wave”) has flattened, the second peak (second wave) has been even more detrimental, with a rapid rise leading to an unprecedented burden on healthcare infrastructure and resulting in high mortality. The second wave has been predicted to be triggered by a double mutant strain, which resulted in a higher incidence of pneumonia, faster progression of the disease, increased oxygen requirements, and higher mortality. In contrast to the current treatment options available, which include antivirals, antimalarial, and anti-inflammatory agents, MSC can be proved to be a better treatment modality for COVID-19. In this article, we focus on the role and use of mesenchymal stem cells (MSC) as a potential therapeutic measure to win the battle against the SARS-CoV-2 virus.

A Scoping Literature Review of Recall and Memory Psychometric Tools

Tue, 12 Apr 2022 00:00:00 +0000

Aim: This scoping literature review aims to determine what is known about 1) the method of testing memory for both long-term and short-term memory and 2) determine which of these methods may be useful in testing the memory.
Background: Several cognitive domains are actively utilized in basic adult activities of daily living (ADLs). These can and are often tested by different cognitive batteries and are necessary to test for patients to receive social support funds and access to programs.
Methods: The study follows the established methods for a scoping literature review with guidelines to identify memory tests, their validity within the field, and the different test limitations within its major age demographic. The article restricts its research to articles published between 1985 to 2021 published quantitative and qualitative primary studies, evaluation research, and systematic and other types of reviews are included if they address different cognitive and memory abilities along with different memory test applications and their use within different major age demographics, and they are published in English.
Results: The combined search strategy yielded 93,000 articles, of which 88 are included. The use of different memory tests in the major age demographics (pediatrics, adult, and geriatrics) was evaluated, and the findings from the different articles were summarized in written form and a table.
Discussion: These 88 peer-reviewed sources were utilized to develop this scoping literature review on the current standard assessment tools for measuring the psychometric properties of memory, recall, and learning.