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 is open to adults who are at least 18 years old and have a body mass index (BMI)bof 27 kg/m2 or more. People can take part if they have cardiovascular or chronic kidney disease. People who have at least 2 health problems related to their weight or risks of cardiovascular disease can participate. Participants must have previously tried to lose weight by changing their diet. The purpose of this study is to find out whether people with overweight or obesity who take a medicine called survodutide (BI 456906) are less or more likely to develop serious cardiovascular problems. It also aims to find out whether health parameters like blood pressure improve. Overweight and obesity are linked to cardiovascular disease. Survodutide is a medicine that is developed to help people with obesity or overweight to lose weight. Participants are divided into 3 groups of almost equal size. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under the skin once a week. All participants also receive counselling on diet and physical activity. Participants are in the study for up to 2 years and 3 months. During this time, it is planned that participants visit the study site up to 21 times and attend remote visits by video calls. During these visits, the doctors check participants' cardiovascular and overall health. The results are compared between survodutide and placebo groups. The study staff also takes note of any unwanted effects.
This diagnostic accuracy study aims to evaluate the performance of bedside ultrasound compared to x-ray in detecting the correct position of feeding tubes among critically ill adult patients. The main questions it aims to answer are: • diagnostic accuracy of bedside ultrasound • feasibility of its wide adoption among practitioners with minimal training in busy intensive care units.
Blood flow restriction (RFS) is a widely studied technique that combines low-intensity exercise with vascular occlusion, resulting in muscular benefits. However, its application is challenging due to methodological variations and equipment costs. Tissue Flossing (TF) appears as an affordable alternative, but lacks solid scientific evidence.
Different physical and mental morbidities such as pain, fatigue, depressed mood and cognitive impairment can be triggered by coronavirus infection. Transcranial direct current stimulation (tDCS), an easy-to-apply, non-pharmacological and safe technique, has been used to attenuate these symptoms caused by other diseases, and, therefore, it is expected that it can also attenuate them when generated by COVID-19. It is known that the persistent inflammatory state observed after COVID-19 would be related to the progression of these negative symptoms. As non-invasive brain stimulation can also attenuate acute and persistent inflammation, it can be estimated that tDCS can be a useful tool to recover immune function and reduce post-COVID-19 morbidity.
The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)
The goal of this clinical trial is to compare the effects of adjuvant antimicrobial photodynamic therapy (aPDT) as an adjuvant of scaling and root planing with scaling and root planing alone for periodontal treatment in patients with periodontal disease and obesity. The main question it aims to answer are: Does adjuvant aPDT improves periodontal health? Are there differences in the proteomic profile of gingival fluid after both treatments? Participants will receive scaling and root planing complemented or not by aPDT. Results will be collected after 1, 3, and 6 months. Researchers will compare adjuvant aPDT treatment to regular treatment to see if it promotes reduction in inflammation and improvement in periodontal health.
The goal of this clinical trial is to compare the effects of photobiomodulation with red laser on gingival graft donor areas of the palate in comparison to only protection with wound dressing. The main questions it aims to answer are: Does photobiomodulation on the palate promote faster somatosensory recovery? Does photobiomodulation reduce pain in palate donor sites, improving the quality of life? Participants who need gingival graft surgeries will receive laser irradiation on the palate donor area or just protection with wound dressing. Data will be collected up to 60 days. Researchers will compare protection on the palate and protection plus laser irradiation to see if laser therapy may reduce pain and accelerate somatosensory normalization. Moreover, they will measure changes in the quality of life after treatment.
This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naive. Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX. Study details include a run-in period (6 weeks ± 3 days) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of therapeutic vaccination with chimpanzee adenovirus (ChAdV)- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen with the Toll-like Receptor 7 (TLR7) agonist vesatolimod (VES) and two broadly neutralizing antibodies (bNAbs) compared to placebo, to induce HIV-1 control during analytic treatment interruption (ATI).
Objective: To compare the effects of two low-power laser therapy protocols (application of a wavelength in the mouth, red region and another in the neck infrared region X simultaneous dual application of two wavelengths, red and infrared region in the mouth and neck) in the prevention of oral mucositis and oropharyngeal pain, dysphagia, TPN and opioid use in patients undergoing HSCT allogenic. Materials and methods: This is a phase III, double-blind, randomized study that will use LBP to prevent oral mucositis and oropharyngeal pain in two protocols with different dosimetry (divided into Group A and Group B). Patients will be included enrolled at the Bone Marrow Transplant Center - Cancer Hospital I - INCA, with indication of allogeneic HSCT, over 18 years old, able to cooperate with the treatment and perform the oral hygiene protocol, who present oral mucosa complete on the first day of conditioning (D-7) and who agree to participate in the study through the term of free and clarified informed consent. The randomization will be carried out in permuted blocks using the REDCap® program by a member of the non-blind team. In group A, extraoral applications will be carried out with the issuance of radiation in the infrared region of the electromagnetic spectrum (808nm) and intraorally in the red region of the electromagnetic spectrum (660nm). In group B, the extra applications and intraoral will be performed with simultaneous double radiation emission in the regions red and infrared of the electromagnetic spectrum (660nm/808nm). for both groups will use the device from DMC (São Carlos, São Paulo, Brazil), with a indium gallium aluminum phosphide (InGaAlP) and aluminum gallium arsiade diode (AlGaAs), with a power of 100mW and a beam area of 0.09842 cm². The LBP will be performed by a dental surgeon, on weekdays, starting on D-7 and end on the day of the "marrow take" (patient presents 500 neutrophils for three days consecutive). The region treated in extraoral applications will be the carotid triangle bilateral, bounded by the superior belly of the omohyoid, posterior belly of the digastric and by the anterior border of the sternocleidomastoid muscle; and intraorally, the mucous membranes right and left cheeks, lower and upper lips, upper and lower labial mucous membranes, right and left lateral borders of the tongue, lingual belly, buccal floor and soft palate. Patients will be evaluated daily (weekdays per week) for oral mucositis, pain in the oral cavity and oropharynx, dysphagia, use of total parenteral nutrition and opioids. Patients and dentists responsible for evaluating patients will be blinded to the study, that is, they will not know about the treatment that the patient will receive. The data from interest will be collected from the physical records and electronic systems of the institution, through standardized forms and will be included in REDCap®. Statistical analyzes will be carried out using the latest available version of the R software for Windows. It will be A descriptive analysis of the data found in the clinical, laboratory and sociodemographic data. To compare the incidence of mucositis, dysphagia, pain (treating the variables as dichotomous), the chi-square test of Pearson. Statistical analyzes will be performed using the latest available version of the R software for Windows. A descriptive analysis of the data found will be carried out in clinical examination, laboratory and sociodemographic data. To compare the incidence of mucositis, dysphagia, pain (treating the variables as dichotomous), the Pearson's chi-square test. Mucositis-free survival analyzes (any degree) and dysphagia (any degree) will be performed by the Kaplan-Meier method and the curves compared by log-rank test. The time interval between the start of conditioning and date of first grade ≥1 mucositis or dysphagia to date of the "marrow take" (500 neutrophils in the peripheral blood for three consecutive days). Participants without mucositis or dysphagia will be censored on the date of marrow collection. Tests of hypothesis with p-value < 0.05. The sample calculation predicted 82 patients, who will be evaluated by intention of treatment, counting with 10% loss to reach 37 patients in group A and 37 in group B. The estimate of the presence of oral mucositis grades 2, 3 and 4 in group A is 36.8% and in group B 10%. The estimate of the presence of dysphagia grades 3 and 4 (or pain in oropharynx grades 2 and 3) in group A is 80% and in group B 40%. the statistical test The two-tailed Z test with pooled variance was used, with a type 1 error of 0.05 and the error type 2 of 0.20. This research project was approved by the Research Ethics Committee responsible (CAAE 67172223.9.0000.5274, opinion No. 5.947.434) and will be conducted in a according to Resolution 466/12 of the National Health Council and the Good News Guide Clinical Practices.