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.
The purpose of this Phase 2, open-label, sequential dose cohort study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of CRN04894 in participants with classic congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency.
The objective of the study is to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) in improving pain in patients with TMD pain after 5 weeks of treatment, 1 month and 3 months after the end of treatment. As secondary objectives, we plan to evaluate the effectiveness of focal shockwave therapy in relation to: 1. Range of motion (ROM) of the temporomandibular joint using goniometry after 5 weeks of treatment; 2. Degree of inflammation, using ultrasound evaluation in the temporomandibular joint relating to the degree of pain after focal shockwave therapy for 5 weeks; 3. Jaw movement (MM), joint noise (RA), joint pressure (PA) and disability index (DI) will be measured at each treatment session and after 5 weeks of treatment, 1 month and 3 months after the end of treatment in the affected joints; 4. Quality of life will be assessed using the "Short Form Health 36" questionnaire (SF-36) during the 5 weeks of treatment, 1 month and 3 months after the end of treatment; 5. Pain control medication will also be considered and compared before and after the proposed treatment for 5 weeks. Safety will be assessed throughout the study by monitoring the incidence of study-related adverse events. All patients will be contacted periodically and encouraged to report any side effects.
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.
The objective of this randomized clinical trial is to test the effectiveness of a low-cost hybrid remotely monitored parent-mediated and clinic-based multidisciplinary early intervention (EI) for low-income infants with CHD in Brazil. The intervention protocols will be administered according to age modules, families will be monitored weekly. High risk infants also receive supplemental clinic-based interventions according to developmental needs. Controls will receive standard of care and access to early child development and nutrition practices information from the Brazilian Ministry of Health. All infants will be evaluated at within a 42-month follow-up research outpatient clinic, called NeuroCardio Baby at Santo Antonio Pediatric Hospital, of the Santa Casa de Misericordia Hospital Complex, and affiliated with The Cardiology Institute-University Foundation of Cardiology (IC-FUC), Porto Alegre, Brazil.
The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).
This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.
Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
Prostate cancer is the second leading cause of cancer death in men. According to estimates by the American Cancer Society Prostate for 2022, about 268,490 men would be diagnosed with prostate cancer and 34,500 would die from the disease. Clinical evolution follows the clinical stages are: localized disease, biochemical recurrence after surgery or radiotherapy, and castration-sensitive or castration-resistant metastatic disease. Localized disease is often classified according to a risk stratification system, which includes assessment of the Gleason score, prostate-specific antigen (PSA) at diagnosis, number of involved fragments per disease at biopsy, and clinical T-staging. Gleason score greater than or equal to 8, PSA greater than or equal to 20 ng/dL at diagnosis, and/or involvement of the prostatic capsule or seminal vesicle are high-risk criteria for biochemical recurrence and later development of metastases, for which the standard treatment is radical prostatectomy or radiotherapy plus androgen deprivation therapy. Prostate-specific membrane antigen (PSMA) is highly expressed on the surface of prostate cancer cells, with relatively low expression in normal tissue. PSMA has been explored as a target in imaging studies using positron emission tomography (PSMA-PET) to reveal occult metastatic disease, as well as a target in the development of PSMA-based treatments with radioligands. According to Hoffman et al., performing PSMA-PET demonstrated greater sensitivity (85% vs. 38%) and specificity (98% vs. 91%), and determined more changes in patient management (28% vs. 15% ) compared to conventional images. Other studies have also demonstrated the greater accuracy of PSMA-based radiotracers compared to conventional images. Finding strategies that increase PSMA expression is a necessity for patients with prostate cancer. According to researchers, high SUVmax values are associated with better outcomes in patients treated with 177-lutetium-PSMA-617. PSMA expression can be rapidly modulated by androgen suppression. The investigators understand that there is great potential to evaluate darolutamide as a PSMA expression enhancer. However, to date there are no prospective data evaluating the effect of ARSI in increasing PSMA expression in localized disease. Here the investigators propose a phase 2 study to investigate the efficacy of a limited course of darolutamide as a PSMA expression enhancer in men with localized prostate cancer according to conventional imaging. PSMA-PET/CT scans will be acquired before and after treatment with darolutamide, as detailed in the protocol. Slides of prostate biopsies and prostatectomies stained with hematoxylin and eosin (H&E) will be reviewed by two pathologists to select the most representative tumor block. Immunohistochemical (IHC) reaction using standard protocols will be performed using an anti-PSMA antibody and intraprostatic anti-androgens. Gene expression analysis will be performed using RNA extracted from biopsies and prostatectomies and evaluated by a panel of over 300 transcripts. For methylation patterns, hematoxylin and eosin (H&E) slides from prostate biopsies and prostatectomies will undergo DNA extraction and evaluation of the methylation profile performed using a kit. It is expected to identify that treatment with darolutamide increases PSMA expression and that the biochemical mechanisms involved can be better evidenced.
The goal of this clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 24 hours since the onset of stroke symptoms, or last known normal. Subject will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participating in the trial is for 5-7 days or hospital discharge (whichever is earlier).
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).