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.
According to World Health Organization (WHO), since December 2016, Brazil is showing a significant increase in cases of yellow fever in humans. In view of this, vaccination is suitable for residents and travelers to the risk area. However, for immunosuppressed patients there is a formal recommendation not to vaccinate with live virus vaccine. On the other hand, the safety and efficacy of the vaccine has been demonstrated in patients with HIV, and safety and seroconversion have also been demonstrated in patients with rheumatic disease who were inadvertently revaccinated for yellow fever. Faced with the impossibility of leaving the high-risk area for some patients the vaccination could be released to only those who have low level of immunosuppression as suggested by some recommendations of medical societies. The availability of a fractional vaccine in the State of São Paulo, which has proved its efficacy, opens the possibility of exposure to a lower number of copies of the virus in the first exposure of immunosuppressed patients, allowing, if necessary, a safer revaccination, after 28 days to obtain of a more effective immunogenic response. The objectives of the study are to evaluate the immune response of the immunization with fractional yellow fever vaccine (neutralizing antibodies) in patients with systemic autoimmune rheumatic diseases residing in a high-risk area. Secondarily, evaluate the possible association between immunogenicity and vaccination with: demographic data, clinical and laboratory activity of the disease in patients with chronic rheumatic diseases, evaluate the curve of viremia and report adverse events. Patients and healthy controls will be vaccinated for yellow fever in the Immunization Center of Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP). The patients' screening for exclusion and inclusion criteria will be done at the rheumatology outpatient clinic after medical evaluation. For the controls will be the routine screening of the Immunization Center. The vaccination protocol will be a fractional dose of the yellow fever vaccine on day D0 for both groups. Patients will be evaluated on day D0, D5, D10, D30-4 and D365 and controls only on days D0, D10, D30-45 and D365 for aspartate aminotransferase (AST), alanine aminotransferase (ALT), platelets, urea and creatinine, immunoglobulin M (IgM) by immunofluorescence for Yellow Fever, viremia, autoantibodies.
The purpose of this research study is to evaluate the efficacy and safety of an empagliflozin dosing regimen and one dose of linagliptin in patients with type 2 diabetes who are aged 10 to below 18 years and are currently taking metformin, insulin or both drugs (DINAMO TM) or who are treatment naïve or not on active treatment after metformin withdrawal (DINAMO TM MONO) . Empagliflozin and linagliptin are both approved for use in adult patients with type 2 diabetes. This study will assess how well empagliflozin and linagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Empagliflozin and linagliptin are considered investigational products in this study since while they have been approved for use in adults, they have not been approved for children and adolescents due to lack of clinical studies in this specific population. Patients with type 2 diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease. The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation. Empagliflozin is a drug that helps to reduce blood glucose (sugar) levels by causing glucose to be excreted in the urines. Linagliptin works by increasing the production of insulin (a hormone that controls the level of blood glucose) after meals when blood glucose (sugar) levels are too high. This helps to lower blood sugar levels. The subject will either receive one of the active study drugs or a placebo. This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive. Which treatment the subject receives is decided by a computer, purely by chance; this is called a "random assignment". For this study, there will first be a screening visit, followed by a 2-week placebo run-in period (all subjects will take placebo once daily). This run-in period is designed to ensure subjects are able to take the study drugs as described in the study protocol. Thereafter there will be a 26-week treatment phase (week 1-week 26) and a 26-week safety extension period (week 27-week 52). Following this there will be a follow-up visit at week 55. On Day 1 after the placebo run-in phase, the subject will be randomly assigned to receive one of the 3 treatments: empagliflozin 10 mg, linagliptin 5 mg or placebo in a blinded manner. This treatment will continue up to week 14. Then after week 14, the subject will be assigned to receive one of the following 4 treatments: empagliflozin 10 mg, empagliflozin 25 mg, linagliptin 5 mg or placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as on Day 1 but some subjects will receive a higher dose of empagliflozin. After the completion of the 26-week treatment period, the subject will enter a 26-week safety extension period. The same active treatment that the subject had been assigned to at week 14 visit will be continued. Subjects assigned to placebo on Day 1 will be randomly assigned to receive one of the 3 active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg in a blinded manner. This safety extension period is primarily designed to provide additional information on how well empagliflozin and linagliptin are tolerated. Following the treatment phases, there will be a follow-up visit at week 55 Intervention model description: Eligible subjects with HbA1c of 6.5% to 10.5% at screening will be randomized in a 1:1:1 ratio to receive empagliflozin 10 mg, linagliptin 5 mg or placebo. HbA1c assessment will be performed at Week 12. All subjects with Week 12 HbA1c < 7% will remain on previously assigned randomized treatment. Subjects taking empagliflozin with Week 12 HbA1c >= 7% will be re-randomized in a 1:1 ratio to continue on the low dose treatment (empagliflozin 10 mg) or up-titrate to the high dose treatment (empagliflozin 25 mg). Subjects taking linagliptin or placebo with Week 12 HbA1c >= 7% will remain on previously assigned treatment. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding. At Week 26, all subjects previously assigned to placebo will be re-randomized in a 1:1:1: ratio to receive one of the active treatments: empagliflozin 10 mg, empagliflozin 25 mg or linagliptin 5 mg. All subjects will get new medication kits dispensed at Week 14 to maintain the blinding.
The purpose of this study is to determine the efficacy and safety of baricitinib in combination with topical corticosteroids in participants with moderate to severe atopic dermatitis who have experienced failure to cyclosporine or are intolerant to, or have contraindication to cyclosporine.
Recent studies with photobiomodulation therapy (PBMT) have shown positive results delaying skeletal muscle fatigue and improving the status of biochemical markers related to skeletal muscle damage when these therapies were applied before exercise. The aim of this project is to verify the effects of PBMT in improvement of skeletal muscle performance and skeletal muscle recovery in healthy male subjects. This project aim also to validate the concept that simultaneous use of three wavelengths and light sources lead to optimized action independently of time-window between irradiation and the exercise.
The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. For that, it will be compared the tomographic bone gain 6 months after surgery between a group that received inorganic bovine bone alone (n=8) and a group that received inorganic bovine bone associated with NFB (n=8).
Background: Photobiomodulation with low-level laser therapy (LLLT) has been widely used in clinical practice for diverse purposes, such as modulation of the inflammatory process, acceleration of the tissue repair process, pain relief and the enhancement of post-exercise recovery. Studies have demonstrated a beneficial interaction between photobiomodulation and the production of creatine kinase, with a reduction in the release of this marker of muscle damage when laser and/or LEDs is administered prior to high-intensity physical activity. The aim of the proposed study is to determine the influence of pre-exercise phototherapy on post-exercise muscle recovery. Methods: A randomized, cross-over, sham-controlled, double-blind, clinical trial is proposed. The participants will be healthy professional soccer players aged 15 to 20 years from the same team with a body mass index within the ideal range (20 to 25 kg/m2) and no history of lower limb musculoskeletal injuries or surgery or back surgery in the previous six months. The athletes will be allocated to two groups based on the previously calculated sample size and will be blinded to allocation. Creatine kinase will be measured and the subjective perception of fatigue will be determined for each participant. The volunteers will then be randomly allocated to Group A, which will receive active phototherapy, and Group B, which will receive sham phototherapy. The athletes will undergo reevaluations immediately after as well as 48 hours after a football match. The data will be submitted to statistical analysis and the level of significance will be set to 5%.
As a therapeutic modality, cryotherapy is highly used for soft tissue damage control during acute and subacute stages. Cryotherapy is able to reduce pain, inflammatory condition, muscle spasm, nerve conduction, metabolic rate, edema formation and to prevent secondary hypoxic injury. These effects are due to the heat conduction, passing from tissue to different cryotherapy modalities, leading to tissue temperature reduction. The diversity of cryotherapy modalities in clinical practice, like crushed-ice packs, frozen food, gel packs and wetted ice packs, are widely explored by studies. To achieve anesthesia by cryotherapy it's settled that the skin temperature must reach 13,6 degrees celsius (ºC). Ice packs are the most effective modality of cryotherapy when placed directly on the skin, this effectiveness is accentuated when ice packs are associated with water. To improve the contact area the pack must be wrapped. Even though wetted ice packs are the most effective modality, there are few studies approaching it. There aren't studies analyzing an ideal percentage of water to ice in this modality either. Also, it isn't observed if the amount of water interferes on the conduction of the heat from the skin to the ice pack, and in rewarming time. Besides neither of the studies measures the amount of pain during cryotherapy application, and if there was any difference between wetted ice packs, and ice packs isolated. Therefore, the purpose of this study is to analyze the most effective cryotherapy modality for reducing skin temperature, rewarming time, and the amount of discomfort during the application.
This study aims to compare the effects of transcranial direct current stimulation on the clinical and cognitive function in patients with chronic migraine.
The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the pivotal studies (MVT-601-3001 or MVT-601-3002).
The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.