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 randomized, multicenter, double-blind, placebo-controlled Phase III study that will evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine produced by Butantan Institute. The study will be carried out in multiple sites in Brazil. The study will be community-based in select urban areas where there's dengue transmission. Study's intervention will be a single dose of the tetravalent dengue vaccine or placebo in a ratio 2:1. For efficacy analysis will be considered all dengue cases occurring after 28 days post-vaccination in the entire population of 16944 participants. For safety analysis participants will be divided in three age groups: 18 to 59 ys, 7-17 ys and 2 to 6 ys. In each of these age groups there will be a minimum of 4992 participants. The age groups of 18 to 59 ys and 7 to 17 ys will start first. Once safety data for the first 21 days after vaccination is analysed for 450 participants in 7-to17-ys age group, the following group, of 2 to 6 ys, will start. The study's hypothesis is that the vaccine under investigation and produced by Butantan Institute is safe and provides protection against dengue symptomatic disease of 80% or more with a lower bound of the 95% confidence interval of 25%. This way, the expected number of dengue cases virologically confirmed is 24 or more which will provide a response in terms of vaccine efficacy. All participants will be followed up for five years to verify dengue incidence, regardless severity.
This trial will enroll patients that have been diagnosed with a transient ischemic attack (TIA) or minor stroke that has occurred within the past 12 hours. Anyone diagnosed with a minor stroke faces the possibility of long-term disability and even death, regardless of treatment. Stroke symptoms such as weakness, difficulty speaking and paralysis may improve or worsen over the hours or days immediately following a stroke. TEMPO-2 is a minor stroke trial for patients presenting within 12 hours of their symptom onset. Patients will be randomized to TNK-tPA or standard of care. In the intervention group TNK-tPA is given as a single, intravenous bolus (0.25mg/Kg) immediately upon randomization. Maximum dose 50mg. The control group will receive antiplatelet agent(s) as decided by the treating physician. Antiplatelet agent(s) choice will be at the treating physician's discretion. TEMPO-2 Coordinating Centre is located in Calgary, AB, Canada. There will be approximately 50 sites participating worldwide. Dr. Shelagh Coutts is the Principal Investigator.
The Chronic Obstructive Pulmonary Disease (COPD) has shown a progressive increase of morbidity and mortality, suggesting that the lung as a single therapeutic target, has not contributed in the past 20 years, significant changes to the natural evolution of the disease. Direct treatment for systemic changes and comorbidities, in fact, the most responsible for high rates of treatment failure could mean a new hope of life for individuals with COPD. This research project characterized as interdisciplinary and multidisciplinary program will be headquartered in Pulmonary Rehabilitation of the Santa Cruz Hospital which has partnerships with local companies . Its main objective will be to analyze cardiorespiratory and functional capacity in COPD patients not rehabilitated and rehabilitated after the period from 02 to 12 months of treatment in a Pulmonary Rehabilitation program in the municipality of Santa Cruz do Sul - Rio Grande do Sul. Will be included in this survey of COPD patients who were referred to a rehabilitation program with a clinical diagnosis of disease. In research activities to assess cardiorespiratory and functional capacity of COPD, pre and post-program (02 and 12 months) are provided for Pulmonary Rehabilitation. The research subjects will also be subjected to physical exercise protocol as recommended by the GOLD (2009), a period of eight weeks, often 2x / week, where their vital signs are measured before, during and after each session. Thus, it is believed that it will be possible to refine the knowledge of mechanisms by which the judicious use of pulmonary rehabilitation can control the progression of COPD.
Pulmonary dysfunction presented in patients with heart failure is observed as a decrease of maximal aerobic capacity compared to healthy people. Lung function deterioration manifests, in the presence of muscle fatigue and dyspnea on exertion, loss of functional capacity, and activities limitation of daily living. Those manifestation influence the perception of quality of life of patients1. Patients with heart failure need to develop changes in lifestyle and daily activities aiming to maintain clinical control and prevent the onset of complications and disabilities. If these changes are not often performed, they might carry bigger burden to for the individual and their family and for the healthcare system due to increasing of morbidity and mortality between those patients2. Systematic reviews conducted in developed countries (USA3, UK4 and Canada5) and developing countries (Colombia6) have shown that telehealth can produce positive effects in individuals with chronic diseases as heart failure. This kind of intervention seems to be effective in preventing hospitalizations and non-elective emergency visits. In Brazil, telenursing is still a non-standardized and non-diffused intervention. In this perspective, telenursing represents soft new tools to provide quality care. It certainly allows the orientation and training of patients, the permanence of them at home, reduces unnecessary hospitalization. Additionally, this intervention, allows the management of nursing time and strengthens their professional autonomy7. The principal aim of this study is to describe the protocol to be used in MRE study. The objective of MRE trial is to test the hypothesis that telenursing contributes to the improvement in lung function over the medium term, in patients with heart failure under continuous education.
The purpose of this study is to show that the modified technique Scopinaro surgery allows a better control or reduction of complications often found in nutritional pancreatic and biliary derivations, starting from the assumption of a modified technique is as effective as Scopinaro classical technique for reducing overweight and control of comorbidities in obese patients with grade II and III.
Prospective study enrolling patients with cerebral palsy and with subluxation of the hips > 40% and acetabular dysplasia. The patients will be stratified according the degree of subluxation and age. The treatment protocol is composed by femur variation osteotomy and periacetabular osteotomy. Patients will be divided in two groups according the type of bone graft used at periacetabular osteotomy (autologous or ceramic).
This study is being performed as a post-approval safety study (PASS), per the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA), to gather data on Translarna (ataluren) safety, effectiveness, and prescription patterns in routine clinical practice.
The purpose of this study was to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free interval of ≥ 12 months after completion of the last rituximab-containing treatment, or who are unwilling to receive chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or residual toxicity.
The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.
In a recent study, which included 845 patients that at the time of ICU discharge had at least one risk factor for readmission, the investigators' group developed a new readmission risk score in the ICU, Safe Discharge from ICU (SD-ICU), using parameters easily and routinely measured in ICU: the Charlson comorbidity (ICC), the TISS-28 (Therapeutic Intervention Scoring System - 28), the length of stay in ICU and age. Through ROC curve analysis, the investigators found that patients with a score above 14.5 had a high probability of readmission. The objective of this study is to validate the Safe Discharge from ICU (SD-ICU) score as a tool to predict unplanned readmissions to the intensive care unit. All adult patients discharged from a 37 bed general ICU from April 2014 to March 2015 will be included in the study. The SD-ICU score is routinely calculated at the time of discharge from the ICU. Patients will be divided into two groups: those with SD-ICU score> 14.5 (group 1) and those with a score equal to or less than 14.5 (group 2). The two groups will be compared with respect to the frequency of unplanned readmissions. Stepwise, multivariate logistic regression will be used to investigate the association between the risk factors for readmission used in SD-ICU score and ICU readmission as outcome.