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 study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival of study participants, when overall survival is defined as the time from randomization until the date of death due to any cause.
Inflammation is an important pillar of atherogenesis in coronary disease. Studies have documented the prognostic power of measuring coronary perivascular adipose tissue attenuation (PVAT) and its good correlation as an early inflammatory biomarker in the atherogenesis process, in addition to being a predictor for cardiovascular events in the future. Colchicine, a medication with well-documented anti-inflammatory action and with an impact on reducing cardiovascular outcomes, may have an action in reducing FAI (fat attenuation index). This study aims to evaluate the effect of colchicine in reducing coronary perivascular inflammation.
The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years. The safety of the smooth-surfaced Silimed® implant will be evaluated by estimating known and unexpected short-term and long-term risk/adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand smooth surface breast implants will be evaluated by evaluating satisfaction and quality of life after implantation.
The primary objective is to evaluate the efficacy of DTX301 on the improvement of ornithine transcarbamylase (OTC) function by maintaining safe plasma ammonia levels with removal of dietary protein restriction and alternative pathway medication.
In this study, the investigators aim to form a Brazilian national prospective active surveillance cohort of patients with low-risk prostate cancer in the public health system. The investigators aim to demonstrate data on the pathological reclassification rate, treatment-free survival, among others. This cohort aim to evaluate and validate the active surveillance strategy in Brazil.
Abstract: Randomized clinical trial that aims to see the efficacy of photoneuromodulation for the treatment of negative symptoms of schizophrenia in patients refractory to transcranial direct current stimulation. In this group of 30 refractory volunteers, magnetic resonance spectroscopy will be performed before and after photoneuromodulation in a cross-over design. Objectives: Effectiveness of photoneuromodulation in patients with schizophrenia. . Analysis of glutamate, Gaba and lactate in spectroscopy before and after stimulation (secondary) Sample: 30 volunteers with negative symptoms of schizophrenia refractory to treatment. Method: clinical trial, cross-over randomized, double-blind, sham-controlled. PANSS negative symptoms subscale evaluation before and after the 10 photoneuromodulation sessions. Participants who are in the active group after the 10 photoneuromodulation sessions will go to the sham group and vice versa. They will perform magnetic resonance spectroscopy before the beginning, after the 10 sessions and again after the inversion of the groups (3 resonances per volunteer). The study will be a cross-over: half of participants will start at sham group and the other half at active group and invert groups after 10th day of stimulation.
Objective: Identifying the dose of EVI-01 with the best clinical response, balancing the efficacy, safety, and tolerability of the investigational product. Study design: Interventional, dose-finding, three arms, randomized (1:1:1), parallel assignment, double-blind, controlled by an active comparator.
Circulatory shock occurs when the supply of oxygen in the tissues decreases, which leads to cell damage and affects about one third of patients admitted to Intensive Care Units (ICU). Cardiac Output (CO) can be defined as the volume of blood ejected by the left ventricle per minute and is a very useful hemodynamic parameter in the monitoring of patients with signs of circulatory shock, since it can help define the etiology and management of such patients. Nevertheless, this parameter is underused in patients treated in Emergency Units, as its measurement usually involves invasive methods and few are available in this scenario. The pulmonary artery catheter is considered the gold standard method for determining the cardiac output, however, since it is an invasive method, in recent decades other devices capable of providing this hemodynamic variable in a less invasive way have been developed. Any method capable of providing CO without the need for pulmonary artery catheter insertion is called minimally invasive CO monitoring. The potential advantages of using these methods include the simplicity of measurements, faster acquisition of hemodynamic parameters and the possibility of implementing a monitoring strategy in places such as emergencies and emergency rooms. The evaluation of these parameters allows a faster determination of the etiology of circulatory shock, which enables the early initiation of goal-guided therapy. It is known that the use of goal-guided therapy proved to be effective in reducing peri- and postoperative morbidity and mortality in patients with high surgical risk; this strategy is also associated with reduced mortality, length of stay in the ICU and on mechanical ventilation in patients admitted to the ICU who are fluid responsive. To date, there is no data regarding the impact of a hemodynamic optimization strategy on patients in the first hours of shock. The investigators aim to assess whether goal-based hemodynamic therapy, through non-invasive hemodynamic monitoring, reduces the incidence of acute renal failure in patients with circulatory shock. A multicenter, randomized, open-label study will be carried out. The study will include patients over 18 years of age with signs of shock (systolic blood pressure less than 90 mmHg and/or mean arterial pressure less than 70 mmHg plus at least one of the following changes: lactate greater than 15 mg/dL, oliguria, neurological changes, and capillary refill time greater than 3 seconds) and who have signed an informed consent form (ICF). Included patients will be randomized in a 1:1 ratio into two groups. The Goal-Directed Therapy Group will be the one in which patients will be monitored by the ClearSight™ System (Edwards Life Sciences, Irvine, CA, USA) in the first 24 hours after randomization, where the parameters cardiac index (CI), systolic volume (SV), systolic blood pressure (SBP) and mean arterial pressure (MAP) will be used to determine medical management; if the CI is less than 2.2 L/min/m² and the SV less than 35 mL/beat, an aliquot of 500 mL of crystalloid solution will be administered; if the patient presents with CI less than 2.2 L/min/m², associated with SV greater than 35 mL/beat, dobutamine will be initiated; in patients with SBP less than 90 mmHg and/or MAP less than 70 mmHg, associated with SV greater than or equal to 35 mL/beat, norepinephrine will be initiated. In the Conventional Therapy group, the allocated patients will be treated according to the assistant team, where the following parameters will be evaluated: blood pressure, peripheral oximetry, heart rate, respiratory rate, and urine output; patients showing signs of hypovolemia will receive crystalloid solution; those who remain with hypotension refractory to volume replacement will be given vasoactive drugs; those with suggestive of cardiogenic shock will be given inotropic drugs; these procedures will be determined according to the clinical judgment of the assistant team.
This is a 52-week, randomized, placebo-controlled, double-blind, parallel group, multicenter study of depemokimab in adults with uncontrolled HES receiving standard of care (SoC) therapy. The study will recruit patients with a confirmed diagnosis of HES and who are on stable HES therapy for at least 4 weeks prior to randomization (Visit 2). Eligible participants must have uncontrolled HES with a history of repeated flare (≥2 flares in the previous 12 months) and blood eosinophil count of ≥1,000 cells/ microliter (μL) during Screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy. Participants who meet the inclusion and exclusion criteria will be randomized in a 2:1 ratio to receive either depemokimab or placebo while continuing their SoC HES therapy.
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for about 3 years. The participants will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years. Which treatment the participants get is decided by chance.