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 is a prospective cohort study, observational, multicentre, single-arm, post-registration to assess the safety of the Adsorbed COVID-19 (Inactivated) Vaccine Sinovac / Institute Butantan.
To demonstrate the efficacy of VERU-111 in the treatment of SARS-Cov-2 Infection by assessing its effect on the proportion of patients who die on study (prior to Day 60).
The use of polyclonal anti-T cell antibodies (ATG) has benefits in kidney transplantation, however, its use is associated mainly with hematological, infectious, and neoplastic complications. Monitoring T cells in patients receiving ATG was first proposed in 1975 to improve efficacy in preventing acute rejection and avoiding excessive immunosuppression. The dose regimen is guided by a daily count of TCD3+ lymphocytes. Monitoring the dose of thymoglobulin through its biological effects on T cells is a rational and safe method of titrating the dose of that antibody. This way, it is possible to reduce the total amount of drug administered to the patient and, consequently, reduce undesirable complications, as well as the cost of treatment, without losing effect on the benefit of immunosuppression. Currently, the usual cumulative dose of ATG for induction in kidney transplant patients is 6mg/kg, in divided doses. However, the ideal dose and duration of therapy are still the subject of studies, with protocols between centers varying from total doses of 3 to 6 mg/kg, either fractionated or single, to achieve the lowest dose with fewer undesirable effects, and with reduced length of inpatient stay. The use of ATG in a single dose of 3 mg/kg was successfully assessed for risks of infection and rejection in patients with low immunological risk. This study proposes evaluating the efficacy and safety of a single 3mg/kg dose of ATG for patients with low and standard immune risk, with TCD3+ lymphocyte monitoring, to assess the duration of the TCD3+ cells in the peripheral blood.
In hypertensive mothers, it is common in clinical practice to substitute methyldopa for another medication, such as captopril, immediately after delivery, which may, as a consequence, cause a rebound effect or an initial lack of blood pressure control until the new medication had a more complete action. Thus, the treatment of hypertension in the puerperium is generally guided by expert opinion and recommendations for guidelines, based on non-robust evidence. OBJECTIVE: To evaluate the control of blood pressure in postpartum women with hypertensive syndromes during pregnancy with the maintenance of the continued use of previously used methyldopa compared to switching from antihypertensive regimen to the use of captopril. METHOD: Randomized, double-blind, drug controlled clinical trial. EXPECTED RESULT: better pressure control with the continued use of methyldopa.
Individuals with HTLV-1 secondary myelopathy (HAM/TSP) may have motor and sensory alterations, which may result in reduced functional performance and consequent risk of falls. The aim of the study is to verify the therapeutic effect of a Pilates exercise program on functional performance and risk of falls, when compared to task-oriented training, of people with HAM / TSP. This is a randomized, crossover clinical trial performed with individuals with HAM / TSP who are attended at a referral center who is able to perform gait whether or not to use a walking aid. Amputees, with psychiatric disorders, rheumatic or orthopedic diseases and other associated neurological disorders, which could influence the balance and functional mobility, as well as pregnant women, were excluded. Participants will be submitted to the initial evaluation of functional mobility, balance, gait balance, fatigue, gait endurance, sphincter changes and questioned about the occurrence of falls in the last three months and will answer a semi-structured questionnaire about their conjugality. They will be allocated randomly to two groups. One will perform the Pilates Method protocol and the other task-oriented training. The first group, called test-control group (GTC), will initiate the protocol with exercises of the Pilates method; the control-test group (GCT) will initiate the task-oriented training protocol. A p <0.05 will be considered a statistically significant difference.
High prevalence of body and eating concerns in Brazilian populations is well-documented, with risk observed across the lifespan. Prevalence rates of body dissatisfaction range between 26.6 - 56% and 10.7- 36% for adolescent girls and boys, respectively (1, 2, 3). The prevalence of these disordered attitudes and behaviours are mirrored in older populations, and have shown to manifest within family units (6). Further, Brazilian consumer trends reflect these attitudes and behaviours, with it being the leading country in diet pill consumption and aesthetic surgeries, and second in the world for total aesthetic procedures (i.e., surgical and non-surgical), with 2.27 million procedures conducted annually (8). Despite the scope of body and eating concerns, few evidence-based interventions have been developed and tested for Brazilian populations and even fewer are accessible, scalable or cost-effective. Harnessing technology to deliver evidence-based care is a key focus for researchers. Micro-interventions (brief, low intensity, self-administered interventions), offer an alternative to traditional, intense interventions that may be unsuitable for milder concerns. Body image micro-interventions have proven effective at providing immediate and short-term improvements in body image among women (9). To date, body image micro-interventions have been developed and evaluated among high-income, White, English-speaking samples, with little research exploring how this intervention model may cater to other cultures and countries. The aim of the present study is to conduct a randomised controlled trial (RCT) to evaluate the immediate and short-term impact of a chatbot on Brazilian adolescents' body image, affect and body image self-efficacy. Primary outcomes include immediate and short-term changes in state- and trait-based body image, respectively. Secondary outcomes include immediate changes in state-based affect and short-term changes in trait affect and body image self-efficacy. The chatbot intervention is designed to target sociocultural risk and protective factors for body image using eight, brief therapeutic techniques derived from several evidence-based theories, including media literacy, cognitive behaviour theory and positive body image. The chatbot was developed through a collaboration between Dove (Unilever), United Nations Children's Fund (UNICEF), The Centre for Appearance Research, and Talk 2 U. The comparison control condition will be assessment only. This is informed by a care as usual framework; whereby, Brazilian adolescents are not currently offered body image prevention or intervention resources at school or within the community. To undertake this project, 2800 adolescent girls and boys will be recruited through an external research agency. Participants will be randomised to either the chatbot or assessment only conditions. Those in the intervention condition, will be encouraged to engage with the chatbot over a 72-hour period, where they will be assessed on state-body satisfaction and affect immediately before and after completing an intervention technique. All participants will be assessed on trait body image, affect and body image self-efficacy at baseline, post-intervention (72-hours) and at one-week and one-month follow-ups. At completion of the one-month follow-up, all participants will receive a debrief form, outlining the study aims and objectives, and additional resources for body and eating concerns. Those in the assessment only condition will be invited to engage with the chatbot; however, their engagement will not be monitored or assessed. Lastly, to compensate participants for their time, they will receive an electronic voucher to the value of approx. US$25 and US$21, for the intervention and control condition, respectively.
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants <6 months of age may subsequently be evaluated.
The use of natural products in the prevention or treatment of chronic diseases is an emerging field in current medicine. And studying the mechanisms of actions by which natural products act in our bodies contributes to the rational use of these products. And the combination of different natural products such as prebiotics (FOS- fructooligosaccharides, GOS-Galactooligosaccharides and beta-glucans derived from yeast), herbal medicine (Silybum marianum), and minerals (Se-selenium, Zn-Zinc, and Mg-Magnesium), o which would result in a synergistic association between them can contribute to achieving not only preventive effects but treatment for chronic diseases such as diabetes and obesity. The present study aims to study the effects of a composition containing natural products on factors and markers that are part of mitochondrial biogenesis and the neuroimmune-endocrine system in healthy volunteers and that present grade 1 overweight/obesity.
In recent years, photobiomodulation has been studied as a means of increasing muscle performance in athletes and healthy individuals. This is possible due to the physiological changes that photobiomodulation therapy can promote. Moreover, given a large number of existing studies on the subject, some directions for future research have been established. For example, future research was established, the relationship between power and time because with high power, it will achieve the same energy with shorter application times. However, irradiation may not be offered for the minimum recommended time. Therefore, this study aims to compare different powers and, consequently, different application times for muscle performance in healthy individuals. For this, 42 participants will be recruited, males between 18 to 40 years old, without recent musculoskeletal injury or cardiorespiratory problems. The participants will participate in 3 evaluations containing functional and physiological variables and ten training sessions of lower limbs with previous photobiomodulation therapy application, comparing devices with a power of 0.864W and 1.864W. 0.864W and 1.2W. Lower limbs training will be composed of stiff and squat exercises twice a week, for five weeks. In the pre- and post-intervention evaluations, the following parameters will be evaluated isokinetic apparatus, body composition, and functionality of the vertical jump. For data analysis, we will use a normality test to verify the distribution and statistical tests will be used for intra and intra and intergroup comparisons, considering two factors in the comparisons time and group. A significance level of 5% will be adopted.
The study aims to evaluate the safety and efficacy of a 2 drugs ART regimen (lamivudine plus dolutegravir) for prevention of mother to child transmission in pregnant women with HIV. 20 pregnant women will be enrolled in this proof of concept protocol. They will be prescribed DTG-3TC (fixed-dose combination), and will be followed up to the end of gestation. Initially, a total of 10 pregnant women will be recruited for the first phase of the study. Once the first phase is successfully completed, 10 additional participants will be included in a second step.