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, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery.
Introduction: warming up has the function of preparing the body structures for a given task to be performed during sports, increasing body and muscle temperature, focusing on improving performance. Therefore, the use of the blood flow restriction technique (BFR) can be seen as a promising alternative for promoting greater mechanical and muscular stress, thus providing a more efficient warm-up and optimizing performance. Objectives: to analyze the effects of RFS used during low-intensity warm-up compared with low-intensity and high-intensity warm-up without RFS on performance (jump test and 30-meter sprint test) and skin surface temperature. In addition to analyzing and comparing, after the warm-up protocols with and without RFS, the acute responses on perceptual outcomes (perception of pain, change in sensitivity, subjective perception of exertion and perception of discomfort in relation to RFS) and muscle outcomes (tonus , muscle stiffness and elasticity). Methods: a randomized controlled clinical trial will be carried out, with 33 amateur soccer players aged between 18 and 35 years who will be randomly divided into three groups: low-intensity warm-up without RFS (30% VO2max), high-intensity warm-up without RFS ( 80% VO2max) and low-intensity warm-up associated with BFR (80% of total occlusion pressure) [30% VO2max-BFR]. All groups will carry out the heating protocol and the outcomes will be evaluated at baseline and immediately after the end of the heating, as well as 10 and 20 minutes after its completion, namely: skin surface temperature through thermography; tone, stiffness and muscle elasticity by myotometry, subjective perception of pain (VAS); pain threshold through the pressure algometer; subjective perception of exertion (BORG scale); perception of discomfort in relation to RFS (LIKERT-CR-10 scale); 30-meter sprints measured through photocells and vertical jump, measured through the force platform. Descriptive statistics will be used and comparisons will be made using the generalized linear mixed model, assuming a significance level of p<0.05.
Background: Breast cancer is the type of cancer that mostly affects women in the world. Although physical and psychological side effects accompany cancer and the aggressiveness of the treatment, regular practice of physical exercise is considered a non-pharmacological tool to improve the quality of life of breast cancer survivors. The present study aims to evaluate the effects of aerobic training programs in aquatic and land environments plus a health education program, compared with a health education program alone, on cancer-related fatigue and other health-related outcomes in breast cancer survivors. Methods: The WaterMama trial is a randomized, single-blinded, three-arm, parallel, superiority trial. Forty-eight women, ≥18 years of age, who have completed primary treatment and been diagnosed with stage I-III breast cancer are recruited. Participants are randomly allocated on a 1:1:1 ratio to 12-week interventions of aerobic exercise training programs either on the aquatic or land environment two times per week plus health education, or an active-control group receiving health education intervention, once a week. Cancer-related fatigue (primary outcome), physical fitness (i.e., muscle strength of the knee extensors, muscle thickness and muscle quality of quadriceps, resting heart rate, maximum oxygen consumption, and performance in functional tests), mental health (i.e., depressive and anxiety symptoms), cognitive function, pain and quality of life are measured before and after 12 weeks of intervention. The analysis plan will use an intention-to-treat approach and protocol criteria. Discussion: The conceptual hypothesis is that both training programs plus health education positively affect cancer-related fatigue, physical fitness, mental health, cognitive function, pain, and quality of life compared to the health education group alone. Additionally, it is expected that the aquatic program plus health education to provide more significant effects on cancer-related fatigue and physical parameters due to its multi-component character, with a consequent greater positive impact on other investigated parameters in this group.
Stroke has been considered one of the main causes of long-term disability in the adult population, and is no longer considered a disease of the elderly, since 2/3 of all strokes occur among people under 70 years of age. According to the Ministry of Health, stroke is responsible for 40% of early retirements, being one of the most important causes of mortality in Brazil. The electroencephalogram (EEG) has been shown to be a very useful tool in the study of functional status and for the diagnosis of brain damage and disorders. It is considered a simple, non-invasive test with high temporal resolution, being a method widely used in laboratories to non-invasively monitor brain activity.
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.
Chagas disease is an endemic problem in Latin America, where millions of people are chronically infected with T. cruzi. Recently, it was assumed to have clinical and epidemiological relevance in several other countries due to migratory and globalizing social factors. CCC occurs in 30-50% of infected individuals, causing considerable morbidity/mortality rates. Heart failure is the most prevalent morbidity. While CRT and drug treatment have been advocated and implemented without much success to improve the clinical condition of patients with CCC, there is no consistent scientific evidence on the role of cardiac contractility modulation (CCM) as a form of adjuvant treatment for heart failure in patients with CCC. The hypothesis of this study is that patients with CCC, advanced heart failure, severe systolic dysfunction, and non-LBB have better clinical and functional responses when undergoing implantation of a CCM device than when undergoing cardiac resynchronization therapy.
The purpose of this study is to assess the long-term safety and tolerability of aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD).
Background: Obesity is considered an epidemic disease of great repercussion on the world and its prevalence has increased in recent decades. The treatment of obesity aims to improve health and quality of life, by reducing body weight. The clinical approach to obesity is routinely the first line of treatment. Clinical treatment usually involves a combination of restriction of caloric intake, modification of behavior and habits, regular practice of physical activity and pharmacotherapy. Clinical treatment of obesity leads to considerable weight loss, but often not sustained in most patients. This long-term sustained weight loss is an attribute of bariatric surgery, since severe obesity remains largely refractory to dietary and drug therapy. Changes in lifestyle that occur in severely obese patients undergoing bariatric surgery, especially in terms of food, lead to the need for the contribution of speech therapy to adapt to the new way of ingesting food. Objectives: to analyze the stomatognathic functions of mastication and swallowing and to verify the effectiveness of orofacial motricity stimulation in adults, severely obese before and after bariatric surgery. Methods: This is a randomized, controlled clinical trial involving severely obese adult patients of both sexes referred for bariatric surgery. This study was approved by the Research Ethics Committee of the Centro Universitário Fundação Assis Gurgacz (FAG) in the city of Cascavel (PR), Brazil, protocol number CEP FAG no. 4,169,295. Patients will be consecutively recruited from the Bariatric Surgery Department of Hospital São Lucas (FAG) and referred to the Speech Therapy Clinic according to the eligibility criteria of the research protocol. After the initial assessment, patients will be randomly assigned to an intervention group (MOG) and a control group (COG). The COG and MOG groups will be evaluated before and after bariatric surgery. Only the GMO will be submitted to the speech therapy training program before bariatric surgery. The myofunctional characteristics will be evaluated through the Orofacial Myofunctional Assessment protocol with Scores (AMIOFE). The AMIOFE protocol was designed according to the assessment models that reflect the physical characteristics and orofacial behaviors of individuals. In this way, the components and functions of the stomatognathic system will be evaluated in terms of appearance/posture, mobility and swallowing functions - liquid and solid - chewing and breathing.
Although CAB LA PrEP has been proven efficacious in blinded randomized controlled clinical trials, additional research is needed to evaluate effectiveness in real world settings as well as to identify effective implementation strategies. The proposed implementation study will assess the safety and effectiveness of open label CAB LA PrEP when offered at public health facilities to cisgender men and transgender or gender non-binary individuals who have sex with persons assigned male at birth. The study will also evaluate two nested implementation strategies, an mHealth education and decision support tool and a WhatsApp injection appointment reminder. The study will also assess overall facilitators and barriers to integrating CAB LA into existing oral PrEP services.
The main objective of this project is to evaluate the genomic information previously associated with cardiovascular diseases (CVD) and its importance as an independent risk predictor (expressed in Odds Ratio) when adjusted for traditional risk factors (smoking, diabetes, arterial hypertension, obesity , anxiety and depression, inadequate diet, physical inactivity, alcohol consumption and apolipoprotein B/A1 ratio (ApoB/ApoA1). An unpaired case-control study of individuals over 18 years of age will be carried out. Cases (N = 1867) will be enrolled right after the occurrence of the first atherosclerotic cardiovascular event (Acute Myocardial Infarction, Stroke and Peripheral Artery Thrombotic-Ischemic Events). The ratio between cases and controls will be 1:1. The controls (N = 1867) will be adult individuals over 18 years of age who sought medical care at the same locations for other clinical reasons (no CVD) or individuals without any overt disease. The genetic evaluation will be performed through the association of Low-covering Whole Genome Sequencing (coverage 0.5-5x) and Whole Exome Sequencing (average coverage 30x).