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 was a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (blinded treatment [BT] period) followed by an open-label extension [OLE] period intended to evaluate the efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After completing the open-label extension period, eligible participants might continue in a long term extension (LTE) Period of 48 weeks.
Molar-Incisive Hipomineralization (MIH) is defined as a qualitative change in tooth enamel of systemic origin, which affects one or more permanent first molars, and may or may not involve permanent incisors. MIH has several clinical repercussions, such as presence of hypersensitivity, difficulty in local anesthesia, reduction of restorations longevity, among others, making it difficult to perform dental treatment. Therefore, the present study will evaluate, through a randomized controlled clinical study, three restorative protocols for the treatment of severe MIH (with post eruptive enamel fracture and dentin exposure). The following groups will be evaluated: direct restoration with composite resin; restoration with composite resin with diode laser application and temporary restoration with glass ionomer cement followed by restoration with composite resin). The restorations will be evaluated after 1 week, 1, 6, 12, 18 and 24 months. The main outcome will be evaluation of restoration longevity, presence of caries lesion and wear of the restoration surface. Other outcomes such as patient satisfaction with treatment, patient discomfort, anxiety, assessment of dentin sensitivity and impact on participants' quality of life, as well as the duration and cost of treatment, as well as their cost-effectiveness ratio will also be evaluated . Multilevel statistical analyzes will be performed to verify the effectiveness of diode laser treatment compared to sealing, in addition to possible factors associated with this efficacy.
Cancer patients undergo many different modalities of treatments. Pharmacological treatment should be well understood. The nutritional status is not taken into account when calculating drug's doses and this may have an impact in toxicity and quality of life. The present study proposes to evaluate the relationship between the calculation of pharmacological treatment's doses, the toxicity and the impact on quality of life among colorectal and breast cancer's patients.
The purpose of this study is to evaluate the efficacy and safety of vutrisiran (ALN-TTRSC02) in participants with hereditary transthyretin amyloidosis (hATTR amyloidosis). Participants will receive vutrisiran subcutaneous (SC) injection once every 3 months (q3M) or the reference comparator patisiran intravenous (IV) injection once every 3 weeks (q3w) during the 18 month Treatment Period. This study will use the placebo arm of the APOLLO study (NCT01960348) as an external comparator for the primary and most other efficacy endpoints during the 18 Month Treatment Period. Following the 18 Month Treatment Period, all participants will be randomized to receive vutrisiran SC injection once every 6 months (q6M) or q3M in the Randomized Treatment Extension (RTE) Period.
Parkinson's disease is a progressive, degenerative neurological disease associated with profound changes in the quality of life of its survivors. Recent evidence has demonstrated the potential use of transcranial direct current stimulation (tDCS) to modulate cerebral excitability and movement control in neurological chronic conditions. However, few studies have investigated the effects of tDCS on postural control in patients with Parkinson's disease. This study aims to investigate the effect of bihemispheric tDCS on postural control in people with Parkinson's disease. Participants will be randomized to receive a single session of anodal and sham bihemispheric tDCS (7 days between each type of stimulation). Primary clinical outcome (balance) will be collected before and immediately after tDCS. The data will be collected by a blind examiner to the treatment allocation.
In vitro fertilization (IVF) techniques have been improving performance recently and, nowadays, provide a live birth rate of around 25%. The success of IVF techniques is dependent upon maximum efficiency at each stage of treatment, and, at the same time, high success rates with a low risk of complications. Multiple pregnancies are one of the most important adverse event of IVF techniques. In this sense, the use of elective single embryo transfer (SET) has become an option for patients with good prognosis compared to the transfer of multiple embryos, and it is recommended in order to reduce the risk of multiple pregnancies and their consequences. On the other hand, it is known that embryonic quality is a crucial step for the success of IVF techniques and the efficiency of this process is linked to the decrease in the number of embryos to be transferred. Usually, embryo selection is based on morphological and developmental criteria. However, recently, it has been demonstrated that the blastocyst biopsy associated with the chromosomal / genetic screening may be a predictor of the chances of implantation. The investigators group demonstrated the feasibility of performing SET sequentially, promoting satisfactory gestation rates and safety for the mother and baby regarding multiple gestation for patients with good prognosis. Based on these principles, the investigators raised the hypothesis that SET associated with preimplantation genetic diagnosis (PGD) by next-generation sequencing (NGS) for patients with good prognosis can improve the success rates of IVF cycles and, at the same time, avoid multiple pregnancies, as well as maternal-fetal and neonatal risks resulting from this condition. To test this hypothesis, the aim of this study is to compare the results of IVF treatments in patients receiving SET (SET group), SET associated with genetic evaluation by NGS (group NGS + SET), elective transference of two embryos (DET group) and DET associated with genetic evaluation by NGS (NGS + DET). In case of non-pregnancy on the first transfer, there will be subsequent transfers until the remaining embryos are exhausted or the patient reaches the gestation. The primary endpoint will be the cumulative pregnancy rate per treatment cycle and this approach will allow to confirm or not the hypothesis that genetic analysis is effective in improving the embryo selection process and associated with SET will increase clinical gestation rates and decrease rates of multiple gestations and miscarriages.
The long stay in mechanical ventilation can induce several complications, among them respiratory muscle weakness, this has been related to the duration of mechanical ventilation, delay and failure to wean, resulting in longer hospitalization, which reflects in greater care increase in hospital costs. Therefore, of this research will be to compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.
Obstructive sleep apnea (OSA) is a common clinical condition, involving the development of arterial hypertension. A Meta analysis study have shown that isometric hand grip training promotes blood pressure reduction. It is going to be conducted a clinical trail to determine the effects of hand grip training in OSA patients to change the arterial hypertension.
The research aims to verify the effects of the Mindfulness Based Health Promotion (PSBM) program on the quality of life of mothers of person with intellectual disability. Method: A randomized, controlled study with pre-post intervention measures and a follow-up measurement will be performed after six months of the end of the intervention. Sample: It will be composed of mothers of the 209 attended with moderate intellectual disability, adolescents and adults of the Service of Socioeducation of the Association of Parents and Friends of the Exceptional (APAE) of São Paulo, excluding those who have any psychiatric problem in the acute phase and minors, or who have regular practice of mindfulness or meditation in the last 6 months.
Considering the severity and high prevalence of ECC, as well as the importance of early intervention and approach, the Atraumatic Restorative Treatment program, because of its advantages, consists of an important treatment alternative. However, only a few studies assess ART in babies affected by ECC. For this practice to be accepted as safe, scientific evidence must be built through longitudinal studies to evaluate ART performance and to this end, the present study is justified. Therefore, the aim of this research was to evaluate the effectiveness of Atraumatic Restorative Treatment performed in babies suffering from ECC after a 4-year period and compare the clinical performance of Atraumatic Restorations performed with two different glass ionomer cements. The investigator's hypothesis is that there is no difference in the clinical performance of ARTs performed with the different GICs. The study is characterized by longitudinal follow-up of a randomized, double-blind, split-mouth-type clinical trial performed in babies affected by early childhood caries. The subjects were children of both sexes, aged between 18 and 36 months, with at least one deciduous molar in each of the different dental quadrants, presenting active cavitated lesions of shallow or medium depth, involving only the occlusal surface. The initial convenience sample consisted of 100 deciduous molars of 25 children attending Bebê Clínica of the School of Dentistry of the Federal University of Rio Grande do Sul-FO / UFRGS, Porto Alegre-RS, Brazil;