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.
We demonstrated the use of the Antimicrobial Photodynamic Therapy as a coadjutant oral decontamination agent. It was also shown that SDS surfactant improves the antibacterial action of APDT when using Curcumin as the photosensitizer. The decontamination levels obtained with APDT are comparable with the levels observed with the use of Chlorhexidine. The clinical relevancy is the control of oral microbial load which will improve the patients' quality of life and will decrease the possibility of cross contamination in the dental office.
This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above was not locally available, a test to confirm ALK rearrangement was performed by a Novartis designated central laboratory. Patients waited for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib.
Objectives: Primary Objective: To perform a pilot clinical study to test multi-modal optical imaging for detection of cervical neoplasia in Brazil. Secondary Objective: Analyze clinical data to establish the imaging modes which demonstrate the highest degree of correlation with disease state.
OBJECTIVE: To evaluate the improvement of patients with gonarthritis exposed to a multidisciplinary care program with and without associated classroom educational program. METHODS: 152 patients (men and women) aged 40 or older with arthritis stages I to III of Kelgren and Lawrence. Have been treated with drugs, orthotics and referred to physical rehabilitation (physiotherapy and/or physical activity). Patients will be randomized into 2 groups of 76 and will go through pre-assessment with multidisciplinary team: Psychologist - assess cognitive ability; level of anxiety, and depression. Nutritionist - anthropometric parameters and diet quality. Social Worker - Level of education, religion, autonomy and mobility capacity to the hospital. Physiotherapist - range of motion, pain, function and quality of life. Occupational Therapy - range of motion and strength. Physical Educator - level of physical activity and functional capacity. Orthopaedic - additional examinations, disease classification, orthotics, report to Social Security and Traffic Department, evaluation questionnaires (SF 36, VAS, WOMAC, LEQUESNE), referral to physical therapy, physical activity and inform consent. A group will submitted to two interventions, with an interval of two months between each intervention. The control group will only make evaluations / consultations with all professional teams without classes for 2 years, then will attend the courses and will be followed by two more years. Interventions will be lectures and practices with the seven professional teams, covering the topic arthritis (orthopedic team), what is disease, being ill, and the role of the patient in the treatment (psychology) to obtain behavioral change. Lectures and practices with physical therapy and occupational therapy to show the importance of exercise in relieving symptoms (physical therapy), the importance of rest and proper ergonomics at home and at work (occupational therapy). The nutritionist shows proper alimentation. Lecture and practice with physical educator (showing the difference between the laber work and regular physical activity as well as the importance of strength exercises, resistance and stretching) and theoretical class with the social service by calling attention to the importance of leisure. After two months, the second intervention is made in order to verify the acquired concepts. Six months, 1, 2, 3 and 4 years after the first evaluation, the groups will be called to new multi evaluation.
The investigators therefore propose a pilot study to establish the effectiveness of NIRS Neurofeedback training in reducing the intensity of ADHD symptom expression on children, improvement of the cognitive and global functions associated with ADHD, effects on cerebral blood perfusion in the cortex and safety plus possible unknown side-effects.
Frailty is a highly prevalent condition, reaching approximately 7% to 30% of older adults aged from 65 up to 80 years [2]. Although exercises seemed to be beneficial for the frail elders, there is still insufficient evidence to indicate the appropriate modality, frequency and intensity of physical exercises that were able to improve physical functioning in this population [9]. The virtual reality (VR) using interactive games (exergames) have generated broad scientific and clinical interest in recent years[10]. Studies indicate that older adults can benefit from training with exergames in improving mobility [12, 13], lower limb strength [14], cognition, particularly executive function [13], body balance [10, 15-18], reaction time [12] and may contribute indirectly to prevent falls [10, 19, 20]. But, there is still insufficient evidence to suggest that the use of exergames are superior even to other types of intervention [21-23] or in combination with conventional physiotherapy [24] The purpose of this study is to investigate the effectiveness of adding exercises using interactive videogames (exergames) in improving physical functioning on frail and pre frail older people when compared to conventional physiotherapy. A parallel randomized clinical with a 6 month follow-up period will be conducted with 82 frail community dwelling older adults. Participants randomized to the Experimental Group will be submitted to 30 minutes of conventional physiotherapy and 20 minutes of therapy using interactive games Xbox 360 Video Game and Entertainment Microsoft System with Kinect sensor. The Control Group will receive 50 minutes of conventional physiotherapy. Both groups will receive 50 minutes of intervention twice a week for 12 weeks. Primary outcomes will be assessed by the Short Physical Performance Battery, the Usual walking speed test and Four Step Square Test in the baseline, 3 and 6 months after that.
Osteoporosis is a systemic bone disease characterized by low bone mass and microarchitectural deterioration of bone tissue with consequent bone fragility and susceptibility to fracture. Fifty percent of women and 20% men older than 50 y.o. will have an osteoporotic fracture (fragility fracture). Fragility fracture is defined as one that results from a low-energy trauma such as a fall from body height. A previous fracture is an important predictor of a new fracture, especially in the first 5 years after initial fracture. A second fracture can be particularly devastating if it is a hip fracture. Low bone mineral density, measured by bone densitometry, as well as a previous osteoporotic fracture, are the two major risk factors for the occurrence of a new fracture. A more rational approach currently used to minimize the costs of health care in a shorter period of time uses the strategy of firstly preventing the occurrence of secondary fracture, followed by primary prevention strategies. In this context, correct identification of fragility fractures and consequent treatment of those individuals is imperative. There are currently insufficient data about the epidemiology and evolution of other fragility fractures, also known as non-vertebral non-hip fracture (NVNH). Among these, distal radius fracture and proximal humerus fractures are the most frequent. There is a type of fracture, however, that is simply ignored by the medical community: the knee insufficiency fracture.A possible explanation for this information gap could be the fact that, until a few years ago, this entity was believed to be a osteonecrosis of the knee. Only recently it is becoming clear that the cause of pain and marrow bone edema that occur subtly in older individuals is, in fact, a insufficiency fracture. The perception that this lesion is actually a fracture is relatively new. The knee insufficiency fracture usually occurs in older individuals and those with knee osteoarthritis. This study therefore aims to evaluate whether there is a relation between knee insufficiency fracture and osteoporosis. Moreover, it is expected to find out if this fracture may be defined as a fragility fracture, electing the individuals affected by it to a prophylaxis for the occurrence of new osteoporotic fracture.
This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have any of the following types of cancer: - advanced melanoma (6 months to <18 years of age), - advanced, relapsed or refractory programmed death-ligand 1 (PD-L1)-positive malignant solid tumor or other lymphoma (6 months to <18 years of age), - relapsed or refractory classical Hodgkin lymphoma (rrcHL) (3 years to <18 years of age), or - advanced relapsed or refractory microsatellite-instability-high (MSI-H) solid tumors (6 months to <18 years of age), or - advanced relapsed or refractory tumor-mutational burden-high ≥10 mutation/Mb (TMB-H) solid tumors (6 months to <18 years of age), or - with adjuvant treatment of resected high-risk Stage IIB, IIC, III, or IV melanoma in children 12 years to <18 years of age Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D. The primary hypothesis of this study is that intravenous (IV) administration of pembrolizumab to children with either advanced melanoma; a PD-L1 positive advanced, relapsed or refractory solid tumor or other lymphoma; advanced, relapsed or refractory MSI-H solid tumor; or rrcHL, will result in an Objective Response Rate (ORR) greater than 10% for at least one of these types of cancer. The 10% assessment does not apply to the MSI-H and TMB-H cohorts. With Amendment 8, enrollment of participants with solid tumors and of participants aged 6 months to <12 years with melanoma were closed. Enrollment of participants aged ≥12 years to ≤18 years with melanoma continues. Enrollment of participants with MSI-H and TMB-H solid tumors also continues.
Bone marrow-derived mesenchymal stem cells (MSC) therapy is a promising treatment for several degenerative diseases, including retinopathies and glaucoma, however no previous safety study involving humans has been conducted. The objective of this study is to evaluate effects of autologous bone marrow-derived MSC transplantation in the worst eye of 10 patients with legal bilateral blindness due to glaucoma. Primary outcome are types and severity of adverse effects. Secondary outcomes are changes in visual field, visual acuity, optical coherence tomography, and retinal ganglion cells function.
In a recent study, which included 845 patients that at the time of ICU discharge had at least one risk factor for readmission, the investigators' group developed a new readmission risk score in the ICU, Safe Discharge from ICU (SD-ICU), using parameters easily and routinely measured in ICU: the Charlson comorbidity (ICC), the TISS-28 (Therapeutic Intervention Scoring System - 28), the length of stay in ICU and age. Through ROC curve analysis, the investigators found that patients with a score above 14.5 had a high probability of readmission. The objective of this study is to validate the Safe Discharge from ICU (SD-ICU) score as a tool to predict unplanned readmissions to the intensive care unit. All adult patients discharged from a 37 bed general ICU from April 2014 to March 2015 will be included in the study. The SD-ICU score is routinely calculated at the time of discharge from the ICU. Patients will be divided into two groups: those with SD-ICU score> 14.5 (group 1) and those with a score equal to or less than 14.5 (group 2). The two groups will be compared with respect to the frequency of unplanned readmissions. Stepwise, multivariate logistic regression will be used to investigate the association between the risk factors for readmission used in SD-ICU score and ICU readmission as outcome.