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 study was to determine whether the investigational drug SelG1 when given to sickle cell disease patients either taking or not taking hydroxyurea was effective in preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may prevent small blood vessels from becoming blocked and therefore reduce the occurrence and severity of pain crises. Other effects of SelG1 was evaluated, as well as the safety of the drug and how long it stayed in the blood stream. Funding Source - FDA Office of Orphan Products Development (OOPD)
The disparity between supply and demand for organs has stimulated the development of strategies to increase the availability of kidney grafts. Such strategy involves the use of kidneys with expanded donor criteria (EDC). This is a study initiated by the investigator, open, prospective, randomized, single center designed to compare the safety and efficacy of two immunosuppressive regimens based on thymoglobulin, tacrolimus and everolimus versus thymoglobulin, tacrolimus and mycophenolate sodium in renal transplant recipients with donor criteria expanded.
Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited for issues such as refractoriness and adverse effects. In this context, the investigators investigate a non-pharmacological treatment known as transcranial direct current stimulation (tDCS). To prove that tDCS is similarly effective than antidepressants would have a tremendous impact in clinical psychiatry, since tDCS is virtually absent of adverse effects. Its ease of use, portability and low price are also interesting characteristics for using in primary and secondary health care. Thus, our aim is to compare tDCS against a fully dosed, effective antidepressant. The study will be a non-inferiority, randomized, double-blinded, placebo-controlled, three-arm trial comparing active tDCS/placebo pill, sham tDCS/escitalopram 20mg/day and sham tDCS/placebo pill. Our primary aim is to show that tDCS is not inferior to escitalopram 20mg/day with a noninferiority margin of at least 50% of the escitalopram-placebo effect.
Curative treatment of upper gastrointestinal tract neoplasms is complex and associated with high morbidity and mortality. In general, the patients are already malnourished, and early postoperative enteral nutrition is recommended. However, there is no consensus concerning the best enteral access route in these cases.
The aim of this study is to investigate the influence of electrical stimulation at the speed of blood circulation and tactile sensitivity of the arms of women who underwent axillary dissection for breast cancer.
To evaluate the influence of virtual reality and vibrational therapy in reducing pain intensity secondary to breast cancer before and after application of treatment protocols, through biomedical instrumentation.
This prospective randomized controlled trial will compare endoscopic band ligation (EBL) with propranolol and EBL alone in primary prophylaxis of variceal bleeding among cirrhotic patients with high-risk varices.
Adequate exposure to mycophenolic acid (MPA) is associated with better outcomes in kidney transplantation. This study evaluated repeated, MPA pharmacokinetics (MPA-PK) according to post-transplant time-points and concomitant CNIs. Fifty-two patients, 33 allocated to tacrolimus (TCL) and 19 to CyA (all with mycophenolate mofetil (MMF) and steroids), had the full MPA area under the time-concentration curve (AUC0-12hrs) repeatedly evaluated at days 7, 14, 30, 60 and 180 post-transplant. MMF daily dose was lower in TCL group as per protocol. Dose-adjusted MPA-AUC0-12hrs progressively increased throughout the study period in both groups but profiles were different according to the CNI regimen and time. The majority of patients were underexposed to MPA on day 7 for both groups what reinforces the need of a higher dose in the first week. Dose-adjusted MPA-AUC0-12hrs was higher in TCL group, after day 7, due to both a diminished MPA clearance (for both groups) and higher AUC4-12hrs in the TCL group. There was a progressive overexposure to MPA in order that at day 180, 21-30% of the patients were overexposed to MPA what indicates a time for MPA monitoring and dose correction for long-term follow-up. These PK data suggest that changes in MPA profile occur according to time and CNIs used and suggests that MPA monitoring may be mandatory at specific time-points.
The potential role of vitamin D on disease susceptibility, activity and severity has been considered for several autoimmune rheumatologic diseases include systemic lupus erythematosus (SLE) . Although, there are few studies of vitamin D supplementation in SLE patients, especially in Juvenile Onset Systemic Lupus Erythematosus (JoSLE). The objective of this study is to evaluate the effect of vitamin D supplementation (cholecalciferol 50.000 international units (IU)/week for 24 weeks) on disease activity (clinical and laboratory parameters), fatigue and bone mass.
To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)