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.
Immunobiogram (IMBG) is a novel in vitro diagnostic bioassay developed by Biohope Scientific Solutions for Human Health SL, that allows to measure the pharmacodynamic response to individual immunosuppressive drugs in patients with a renal transplantation. Pharmacodynamics can complement the already available pharmacokinetic information on immunosuppressants and enable a more individualized evaluation of the immunosuppressive therapy. The aim of this study is to evaluate the association between the pharmacodynamic response to individual immunosuppressants taken by the patient measured in vitro with IMBG and the existence of signs of graft rejection in biopsies (upon indication or protocol) performed in a sample of kidney transplant patients. The main hypothesis is that a lower sensitivity to the immunosuppressive drugs taken by the patient will be associated with a higher probability of rejection.
Introduction: The management of patients with chronic burning mouth is a challenge in clinical dentistry. Objective: To compare the effect of Low Level Laser Therapy (LLLT) and Transcutaneous Electrical Nerve Stimulation (TENS) in the treatment of burning mouth. Materials and Methods: Randomized clinical trial consisting of 25 patients with burning mouth who were treated by TENS (n=12) and by LLLT (n=13). Treatment was carried out weekly for 8 weeks. Two-way ANOVA was used to verify whether there was a significant difference between times T0 (baseline), T1 (after the 4th treatment session), T2 (after the 8th treatment session) and T3 (30 days after the end of treatment) in in relation to symptoms, analyzed using the Visual Analog Scale, unstimulated salivary flow, xerostomia and dysgeusia with TENS and LLLT interventions.
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Phase III trial evaluating the safety and efficacy of a single high dose (10 mg/kg) of liposomal amphotericin B for disseminated histoplasmosis in AIDS patients, in comparison to standard therapy (3 mg/kg of liposomal amphotericin B for two weeks) (INDUCTION trial).
SARS-CoV-2 is a highly transmissible and pathogenic coronavirus that emerged in late 2019 and has caused a pandemic of acute respiratory disease, collectively known as COVID-19. Given the relatively short duration of protection after vaccination or SARS-CoV-2 infection and the evolution of immune-evading strains, it is likely that the population will have to be repeatedly boosted until a "universal" Pan-Sarbecovirus vaccine is available. SARS-CoV-2 protein subunit vaccine candidates have shown that, despite adjuvantation, their safety/reactogenicity profile seems to be preferable over mRNA or vectored vaccines, whilst inducing non-inferior immune responses (1,2). In this regard, serious adverse events of special interest from mRNA vaccines seem to be have been substantially underestimated/underreported. In a preliminary analysis by an International consortium, the true incidence seems to be 1,250/million excess risk in vaccinees instead of the 1-2/million reported by the Department of Health and Human Services (3,4). Additionally, in a recent study, the Clover SCB-2019 protein subunit vaccine candidate has shown higher neutralizing antibodies titers against the omicron variant, when compared to an inactivated vaccine (data not published yet). Although Brazil has various vaccine platforms authorized for emergency use or licensed, such as mRNA vaccines, vector-based vaccines, inactivated vaccines, so far Brazil has no access to adjuvanted or non-adjuvanted protein-based vaccines. This study will involve two vaccines registered in Brazil and a protein-based adjuvanted vaccine candidate, SCB-2019/Clover. Protein-based adjuvanted vaccines have the advantage of being from a known and licensed technology that can produce high quantities of vaccine at reasonable Costs of Goods. Protein-based adjuvanted vaccines have also been shown to be highly immunogenic, both in the context of COVID-19 (2,5) and other licensed vaccines (6), with long persistence of immunity and protection. Over 80% of the Brazilian population above the age of 18 years have received a full primary vaccination and another 7% at least one dose of vaccine. The overall booster coverage is about 48% (64% of the adults) (7). Anvisa has authorized 1st and 2nd booster doses of various vaccines in line with the MoH policy which was last updated in March 2022. It can be speculated that, like in other geographies, a third booster will be recommended soon, especially to at risk populations and in the scenario of high circulation of the Omicron BA.5 strain. This study will explore the immunogenicity, safety and reactogenicity of a booster dose of various platforms in fully primed individuals regardless of the number of booster doses they have received prior to the enrollment in the study. This mimics the "real world scenario" at vaccination centers where individuals with different background vaccination schemes show up for "a booster". It would facilitate logistics of immunization substantially if vaccines for boosting, independent of the immunization status, could be interchangeable with respect to safety/reactogenicity and immunogenicity. This study will enroll fully-primed individuals (2 doses of either Pfizer mRNA or Oxford/AZ/Fiocruz or Sinovac/Butantan or 1 dose of Janssen vaccine) who have received their last vaccine dose at least 4 months prior to study entry and who have received either no booster, or 1 or 2 boosters. Individuals will be stratified in cohorts by number of boosters and then randomized to receive one of 3 booster vaccines (AstraZeneca/Fiocruz, Pfizer/Wyeth, SCB-2019/Clover).
This is a randomized controlled trial that intends to verify the effectiveness of the daily practice of meditation before going to sleep for the improvement of sleep, stress, mental health and quality of life of people with sleep problems.
Childhood cancers represent less than 1% of the malignant diseases diagnosed worldwide. Treatment modalities for childhood malignancies will differ depending on the diagnosis. The main treatments may include chemotherapy (QT), radiation therapy (RT), and surgery. The toxicity caused by QT and RT generates adverse effects in the mouth, among them oral mucositis (MO). MO is damage that occurs to the oral mucosa and these lesions are extremely painful, uncomfortable, and cause great morbidity for patients. The main treatment of MO is intraoral photobiomodulation therapy (TBMI), this therapy has been widely used, reducing the severity and pain of MO in patients. The use of extraoral photobiomodulation therapy (TFBME) has been employed in some recent studies and has shown efficacy for reducing and improving the severity of OM. The present study aims to compare the effect of two protocols of photobiomodulation therapy (TFBM) using intraoral and extraoral low power laser in the prevention and treatment of OM in pediatric oncology patients receiving treatment with high dose metrotexate (MTX-HD) and its chemotherapy combinations. Initially, 34 pediatric and adolescent oncology patients receiving intravenous (IV) QT from risk protocols will be selected. Participants will be allocated into 2 groups: Group I: TFBMI (n=17) and Group II: TFBME (n=17). The study will be conducted by a dental surgeon who will perform the initial assessment and reassessments (blinded to the groups) and another who will apply the TFBM. Patients will be evaluated daily from day 1 (D1 - beginning of the chemotherapy cycle) until D10 or until healing of the lesions. The evaluation will consist of oral mucosa examination for grading of OM, pain assessment, quality of life, oral health, depressionand saliva evaluation of patients to assess. The analyses will be performed in the PASW 18.0 program, initially the evaluation of the data distribution will be performed by applying the Shapiro-Wilk and Kolmogorov-Smirnov tests. If, after applying these tests, the data show a normal distribution (p>0.05), the t-test will be used. If the distribution is non-normal after the application of the tests (p<0.05), the Wilcoxon test will be used. The p value will be set at 5%. Logistic regression will be used in adjusted models to estimate the probability of occurrence of OM.
A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M Risk Allele
This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
Cardiovascular diseases (CVD) and neoplasms are the main causes of death in Brazilian women. Coronary artery disease (CAD) and stroke were responsible for approximately 54% of deaths from CVD in this population. In Brazil, cancers were the second cause of death and in 2017 were responsible for 58% of deaths in women. CVD and cancer share some risk factors, and control of these factors is associated with a significant reduction in cancer incidence. These two causes of death, although apparently disparate, share similar lifestyles and health risk factors, suggesting some common pathways and basic molecular networks. In women, the presence of estrogen has protective effects against atherosclerosis and, with the decline in hormone production at menopause, the incidence and prevalence of CAD increase substantially. Although the estrogen pathway is supposed to have a central effect on this increased risk, it is still debated whether other non-estrogenic mechanisms are related, since hormone replacement alone does not reduce cardiovascular events. Sirtuins and soluble advanced glycation product receptors (sRAGE) are associated with increased vascular protection, while the role of apoptosis inhibiting proteins, a pathway linked to increased cancer incidence, is still unclear in the context of atherosclerosis. Resveratrol is a key activator of sirtuins and potentially modulates these metabolic pathways, reducing cardiovascular risk. This randomized, double-blind, parallel, placebo-controlled clinical trial will be carried out in 80 postmenopausal women with CAD to analyze the effect of treatment with resveratrol on serum concentration and gene expression of sirtuins-1 -3, in the serum sRAGE concentration and in the gene expression of apoptosis inhibitory proteins.