There are about 10004 clinical studies being (or have been) conducted in Brazil. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This study employs a randomized, controlled, paired, single-blind clinical trial design. The targeted demographic comprises individuals aged 60 and above. Following the initial assessment, participants will be randomly allocated to two groups: the Intervention Group (ViviFrail) and the Group Suggestions for a Healthy Life (CG), maintaining a 1:1 allocation ratio. Both the ViviFrail group and CG group will exhibit homogeneity in terms of their clinical characteristics and functional performance. The allocation of participants into respective groups will remain concealed from all assessors, ensuring a single-blind approach. In the intervention group (ViviFrail), 25 participants will be instructed to engage in tailored physical exercises outlined in the VIVIFRAIL® protocol within the confines of their homes, with adaptations made according to their clinical conditions and functional performance. Conversely, the Group Suggestions for a Healthy Life (CG) comprising 25 participants will receive exercise suggestions and guidance to maintain a healthy routine for a duration of three months. Subsequently, participants in the CG will undergo the VIVIFRAIL® program intervention for an additional three months.
Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use
The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone. Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 6-weeks (approximately), where reassessment of GFR will occur for the primary efficacy endpoint. In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.
The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to participants with non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy.
Introduction: Health education provided through the escape-room is still a recent approach in educational methodology and tends to be a strategy that benefits nursing students, particularly in gaining knowledge and skills. However, few studies have explored the use of both in-person and virtual escape-room as an educational methodology in nursing. Objective: To assess the effectiveness of the gamification strategy through the in-person escape-room model compared to the virtual model in enhancing cognitive and affective competencies for recognizing cardiac arrhythmias in critical care patients within the nursing field. Method: A randomized clinical trial to be conducted with nursing students from higher education institutions in the Federal District, Brazil. Students will undergo a theoretical class on cardiac arrhythmias in critical patients and will then be randomized to experience either the in-person or virtual escape-room scenario. Knowledge tests, the Depression, Anxiety, and Stress Scale, Satisfaction and Self-confidence Scale in nursing management learning, and perceived gains will be administered pre and post-intervention. Results with p≤0.05 will be considered significant. Expected Results: It is anticipated that this study will contribute to the enhancement and broadening of cognitive and affective competencies in nursing students, improving the quality of care through an active educational strategy like the escape-room, and consequently reducing costs for the Unified Health System by minimizing errors in recognizing clinical changes in critical patients. Additionally, the study aims to address gaps in understanding the use of educational escape-rooms in the field of nursing.
The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with HNSCC (Head and Neck Squamous Cell Carcinoma)
Recent investigations have shown that of the patients who were affected by SARCov2 have remained with persistent symptoms in a high proportion. In these considerations, the literature has suggested nomenclatures such as "post-COVID-19" and "chronic COVID-19", "long -COVID" and Post-Covid Syndrome for patients recovered from SARCov2 reporting persistent symptoms and signs for weeks to months after resolution of the acute infection. Furthermore, there may be cardiovascular complications in affected patients, the consequences of which can lead to muscle contractility disorders, vascular insufficiency, cardiac arrest, reinforcing the need for controlled, randomized studies, as well as follow-up and monitoring of these. Furthermore, cardiovascular diseases (CVD) are part of the health problems that lead to the most deaths in the world, they also lead to a high proportion of hospital admissions, due to the worsening of the pathology and a higher incidence in the elderly population. The worsening of CVD conditions leads to inadequate food consumption at the hospital level, causing changes in several nutrients, including vitamin B12. The reduction in B12 levels leads to changes in several systems, including the cardiovascular system, and due to the increase in homocysteine and the triggering of the inflammatory cascade. Studies indicate that B12 supplementation through Chlorella (microalgae - functional food) reduced cardiovascular risk and modulated the inflammatory cascade. In combination, neurostimulation has presented aspects that promote pain neuromodulation, due to the improvement of respiratory patterns and inflammatory modulation. More specifically, there is a protocol with promoting findings, this being HD-tDCS. In this sense, this research aims to evaluate the effects of HD-tDCS and the consumption of Chlorella Pyrenoidosa to improve B12 levels in patients with cardiovascular risk post-COVID-19.
Creatine is an effective, inexpensive, and safe dietary supplement, which has been largely used in sports and clinical populations. However, creatine is much less studied in female athletes, with long-term data being particularly scant. This study aims to expand our knowledge on the effects of creatine supplementation in young (Under-20) and elite female football players. This study will comprise two experiments. The first one will be a randomized, controlled trial in which young athletes will be assigned into either creatine or placebo (n = 20). Before and 7 days after supplementation or placebo (4 x 5 g/d of Creapure or dextrose at same dose), athletes will perform a battery of performance tests. Blood and urinary biochemical parameters for assessing the safety of supplementation will be analyzed (creatinine, albuminuria, urea, sodium, potassium, liver enzymes, creatine kinase, hematology). Food intake will be assessed by means of 3-d 24-h dietary recalls. The second experiment will have a quasi-experimental design (i.e., pre-to-post), in which both young and elite football players (n = 70) will be supplemented with creatine (4 x 5 g/d for 7 days and then 5 days during the follow-up) and will be assessed for safety using the above-mentioned markers during the regular football season (~12 months). Assessments will be carried out at baseline, in the mid-season and after the season.
Lifestyle habits and health characteristics (e.g., excess weight) acquired in childhood and adolescence have a good chance of being carried into adulthood. In this sense, seeking to understand which factors can influence these habits and/or characteristics is of paramount importance. One of these factors that can influence the health of children and adolescents are the lifestyle habits and characteristics of these young people's parents. One of the lifestyle habits that appears to be related between parents and children is physical activity. However, most studies analyze the practice of physical activity between parents and children only considering the practice of total physical activity, that is, not considering the different domains of physical activity [ i) physical efforts carried out in the work environment, occupations in the case of adults and in the school environment in the case of children and adolescents; ii) physical activities carried out during leisure time; iii) physical activities carried out in the form of active commuting], in addition to there being little information considering the different intensities of physical activity (light, moderate, vigorous and very vigorous). Another gap to be addressed is the relationship between other health variables between parents and children, including unhealthy lifestyle habits, such as smoking, eating disorders and symptoms of anxiety and depression, as well as adverse health conditions, such as the presence of chronic diseases. and overweight, would be different considering the parents' practice of physical activity, for example; whether the possible relationship between excess weight between parents and children would be similar in children of physically active parents when compared to children of insufficiently active parents. Therefore, the objective of the present study will be to verify whether the different domains and intensities of physical activity are related between parents and children, as well as to verify whether other lifestyle habits and health characteristics are related between parents and children, considering the levels of activity. physical status of parents (physically active and insufficiently active).
The objective of the study is to compare the acute cardiorespiratory and perceptual responses to a physical exercise session in those infected by Covid-19 with and without persistent symptoms.