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.
Heart failure is a chronic disease, being the second cause of death in Brazil. Currently, it is estimated that 6.4 million Brazilians suffer from this disease. The higher number of rehospitalization, lower survival of these individuals. There are recommendations from Societies of Cardiology for the inclusion of effective self-care for patients with chronic HF, intend greater control of symptoms, greater adherence to treatment and, consequently, decrease of rehospitalization. One of the pillars of self-care's education for chronic patients recommended by the Health Ministry is the management of the patient's emotional aspects. These have been undertreated in most studies. The prevalence of depression among patients with HF is high and ranges from 41% to 72%, and the assessment with the BDI-II, which is the gold standard used, is 67%. Patients with HF and depression have greater difficulty in adhering to treatment and poor maintenance of self-care. Also, they present 4 times more risk of rehospitalization/mortality. Faced with this problem, this project was designed, proposing an online psychological support group for patients with heart failure and depression, primarily aimed at improving self-care, adherence and secondarily at reducing the rates of depression and readmission.
The goal of this randomized clinical trial with adults is to discuss the effectiveness of the nutritionist's educational interventions in users diagnosed with NAFLD, compared to the usual medical follow-up of users treated at the Hepatic Steatosis Ambulatory of the Complexo Hospital de Clinicas of the Federal University of Paraná (CHCUFPR) in adults diagnosed with liver disease. The sample will consist of patients routinely monitored at the Hepatic Steatosis outpatient clinic diagnosed with non-alcoholic fatty liver disease. Patients allocated in the study will be randomized 1:1 and followed up for one (1) year, intervention group (IG) with nutritionist consultations, nutritional diagnosis and educational intervention with agreement on individual goals. Patients in the Control Group (CG) will maintain the usual outpatient care. Participants will have clinical, anthropometric and sociodemographic data collected and food consumption data will be carried out during the nutrition consultations, as well as the application of the NLS-Br Nutritional Literacy questionnaire to verify literacy. During the nutrition consultation, a 24-hour recall will be carried out to collect information on food consumption. They will also be carried out as monthly telephone contacts or messages via instant messaging application, to solve the doubts of the participants and notify them of upcoming meetings, and subsequent comparison of the LN in the target population. All interventions will be recorded in specific instruments for this purpose. Researchers will compare intervention group (IG) and Control Group (CG) and to see the effects of nutritional intervention. The expected primary outcome will be weight loss of 5% to 10% of the initial weight and the secondary outcomes will be: reduction in abdominal circumference and body mass index, and improvement in the levels of liver transaminases. Data will be analyzed with descriptive and inferential statistics.
The general objective of this study was to evaluate the efficacy of the comprehensive protocol in improving post-stroke upper limb spasticity. The specific objectives were to evaluate pain improvement and changes in quality of life and functional capacity in patients who were subjected to the comprehensive protocol compared with those in the patients who underwent sham interventions.
The purpose of this study is to understand the safety and effects of the study medicine ARV-471 (PF-07850327) given together with palbociclib in advanced breast cancer. In particular, the study will compare the combination of ARV-471 plus palbociclib to standard of care therapy (letrozole plus palbociclib). Both letrozole and palbociclib are medicines already used for treatment of breast cancer. ARV-471 is a new medicine under study. This study is seeking participants who have breast cancer that: - Have a locally advanced or metastatic disease and cannot be fully cured by surgery or radiation therapy. A metastatic disease is when disease has spread to other parts of the body. - Is sensitive to hormonal therapy such as tamoxifen. This is called estrogen receptor positive disease. - Have not received any prior medicine for advanced disease. Example medications include tamoxifen or letrozole or exemestane. The study will have an open-label SLI (study lead-in) before initiation of Phase 3 trial. During SLI, two dose levels of palbociclib in combination with ARV-471 will be explored in parallel. Assignment to the palbociclib dose is by chance. Half of the participant will receive one dose and the other half another palbociclib dose. The purpose of SLI is to determine the recommended Phase 3 dose of palbociclib to be administered in combination with ARV-471. In the Phase 3, half of the participants will take ARV-471 plus palbociclib while the other half will take letrozole plus palbociclib. In both SLI and Phase 3, participants will take the study medicines by mouth, with food, once a day. Participants will take the study medicines until breast cancer increase in size or side effects become too severe. Side effects refer to unwanted reactions to medications. Participants will visit the study clinic about once every 4 weeks.
Fibromyalgia (FM) is a syndrome characterized by generalized musculoskeletal pain, fatigue, non-restorative sleep, cognitive alterations, depressive and neurovegetative symptoms. Conventional pharmacological therapies are known to produce responses with little clinical impact in more than 50% of patients. Functional alterations of the motor cortex and its connections with subcortical structures have also been demonstrated in FM. Based on the above, the objective of this research is to identify subgroups of patients with greater potential for response to treatment with a view to advancing diagnosis and treatment. In this study, the therapeutic target will be transcranial direct current stimulation (tDCS) according to the potential of responsiveness to the placebo effect, with the precise location of the stimulation area by a neuronavigation system, with the objective of counter-regulating the processes dysfunctional factors responsible for triggering and maintaining FM symptoms. Therefore, this clinical trial aims to compare the effectiveness of anodic tDCS applied in the left dorsolateral prefrontal cortex (DLPFC) compared to sham tDCS in FM, according to susceptibility to the placebo effect and serum endorphin levels.
Multiple sclerosis (MS) is a chronic, immune-mediated, demyelinating disease of the central nervous system. Typical brain lesions of the disease may be partially repaired by an endogenous remyelination process which is limited and tends to deplete over the course of the disease. Cladribine tablets are an approved treatment that promotes selective lymphocyte depletion, reducing the inflammatory activity of the disease. The present study is based on the hypothesis that improved inflammatory control through cladribine tablets provides a tissue microenvironment more favorable for remyelination of brain lesions in MS. This hypothesis will be evaluated by a single-arm, open-label, phase IV, single-center, proof-of-concept clinical trial in which 10 participants with relapsing-remitting, highly active MS, relatively early in the course of the disease, will receive conventional treatment with cladribine tablets and will be followed-up for 48 months. Neurological, neuropsychological and magnetic resonance imaging (MRI) parameters will be measured. Remyelination will be assessed by a novel MRI technique called the q-Space myelin map. Additionally, the peripheral blood lymphocyte and cytokine profiles will be evaluated in order to understand the immunological aspects that influence the remyelination capacity in patients treated with cladribine tablets. The study will be conducted in accordance with current regulations governing clinical research in Brazil.
The investigators designed a protocol for a Bayesian unplanned posthoc analysis using the pooled dataset from three large randomized clinical trials. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators will carry out a reanalysis of the harmonised database using Bayesian statistics.
This is an intervention research project, with a pragmatic experimental design of the type Randomized Clinical Trial. Schoolchildren from 6th to 9th grade of both genders, adolescents must be in age group between 10 and 17 years old. enrolled in public schools in the city of Canguçu/RS in the rural zone full-time that have professors with academic training in the area of EF will be allocated in intervention group (IG) and control group (CG). The GI will participate in the inclusion of 15 minutes of functional exercises during the PE class and the GC will continue with the PE classes as planning elaborated by the teachers and pedagogical coordination. The study variables will be organized into main dependents (physical parameters related to health), secondary dependents (parameters behavioral and psychological health-related), characterization of the participants, and independent. After the 12 weeks of intervention, the data will be collected again, in order to compare the data obtained before the intervention. The expected results after 12 weeks will be that the Group intervention has a significant improvement in the physical, behavioral and psychosocial parameters of health compared to the control group.
This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.
This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities.