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 was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.
Age, parity, obesity and a number of comorbidities are the major clinical and lifestyle risk factors for female urinary incontinence and pelvic organ prolapse at the population level. The socioeconomic risks for incontinence have however, conflicting evidence with assorted measures of socioeconomic status. Brazil is a country with enormous social contrasts, and deep inequality. We have a mixed origin of cultures and different economic and regional conditions. We believe that the perception and the impact that has Pelvic floor dysfunction in the quality of life of the woman must vary widely according to socioeconomic status (including household income, highest educational level, family income). There is to date no studies have correlated a criterion for classifying economic official in Brazil with the impact of quality of life (based in KHQ or PQOL) of women with urinary incontinence and pelvic organ prolapse.
Resistance training combined with protein or amino acids supplementation has been shown to be promising for mitigating age-related disabilities and comorbidities. Randomized controlled trials supporting this possibility are still scarce. These series of clinical trials aim to investigate the chronic effects of different strategies of protein and derivatives supplementation in association with resistance training on selected health-related parameters in pre-frail and frail elderly.This is a 16-month, double-blind, randomized, placebo-controlled, parallel-group clinical trial involving a series of investigations. Participants will be divided into nine groups, allowing the assessement of the effects of (1) isolated leucine supplementation; (2) protein source (whey vs. soy); (3) combination of whey protein and creatine; and (4) sexual dimorphism to the response of protein intake plus resistance training (men vs. women). All participants will undergo a supervised, resistance training program.
This research protocol "Comparative pharmacokinetics and pharmacodynamics of peginterferon Bacterial Intravenous Protein 48 kilodaltons (BIP48) and 40 kilodaltons (40kDa) in healthy volunteers." This is a Phase I clinical trial which will compare pharmacokinetic and pharmacodynamic parameters, and safety of two products: peginterferon alfa-2a (PEGASYS ®) and BIP48. It will be a double-blind, randomized crossover with a rest period (wash-out) of 4 weeks. The study population will be 32 healthy male volunteers to whom will be administered a single dose of 180 microgram of each product, subcutaneously. The study will have a total duration of 14 days in each treatment step. The serum concentration of PEG-interferon for both products, measured by enzyme immunoassay (EIA) and by antiviral activity of PEG-interferon, is the main variable.For this purpose 15 samples of each volunteers will be needed. Clinical and laboratory variables, useful as pharmacodynamics parameters Beta-2 microglobulin (β2M) - 2'5'oligoadenylate synthetase - oligoadenylate synthetase (OAS)- and neopterin) and safety evaluation, will be measured.
Clinical trial phase I, randomized, double blind, where 30 individuals will receive the experimental vaccine while 30 other volunteers will receive a meningococcal C conjugate vaccine already licensed in Brazil and available in the National Immunization Program for children less than 12 months of age. The primary outcome of the study is to evaluate the safety profile of the vaccine under test, which should allow its application in humans. Secondly, the investigators will study its immunogenicity from the evaluation of the correlates of seroprotection for meningococcal, defined by the World Health Organization (WHO).
The purpose of this study is to determine the phototherapy may be adjuvant to exercise to improve muscular efficiency and increase aerobic capacity. We hypothesized that phototherapy adjuvant with physical exercise may be benefit to populations with Diabetes mellitus that have impairment in cardiopulmonary fitness and low oxygen uptake peak values (VO2peak) in exercise tests. Two doses will be tested 150J and 300J. Additionally, this study aims to evaluate the effect of phototherapy previously applied to the exercise on the cardiovascular coupling. We hypothesize that phototherapy previously applied to the exercise will result in the increase baroreflex sensitivity (increased coherence and gain and decreased phase), promoting the improvement of the cardiovascular autonomic control and cardiovascular coupling in diabetic subjects. Two doses will be tested 150J and 300J.
To contrast the potential effects of physical exercise training program (PTP) of a 6 versus 12 weeks on cardiac autonomic modulation by linear and non-linear heart rate variability (HRV) indices and functional capacity in moderate-to-severe COPD patients.
In vivo deposition studies of aerosol administration during noninvasive ventilation are scarce in the current literature. We assessed 10 normal subjects in a crossover study evaluated by pulmonary scintigraphy aiming to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) of radiotagged aerosol administered using vibrating mesh nebulizers (VMN) and conventional jet nebulizer (JN) during noninvasive ventilation (NIV).
Recently, there has been a growing interest in the study of nonlinear dynamics as a methodology for complementary analysis to characterize the respiratory pattern. These methods are well established in studies of heart rate. The analyzes evaluate complex signals, including large-scale fractal correlations and distributions in time series, and can provide relevant clinical information. Measures such as approximate entropy and sample entropy have shown great potential in the evaluation of the complexity of the respiratory system, providing information relevant to the understanding of physiological and pathophysiological processes. These measures are based on the concept of non-linearity in the presence of a high number of interconnections, resulting in the complex behavior exhibited by physiological systems. The approximate entropy (ApEn) is related to the amount of clutter, complexity or unpredictability of a data series over time. In a complementary way, the sample entropy (SampEn), is a far more elaborate than the ApEn, to reduce possible biased estimates due to self-similarity. A study conducted by our group in asthma patients with different levels of bronchial obstruction demonstrated a significant reduction in airflow approximate entropy (ApEnV´) in asthmatic subjects. Investigators believe that in COPD, similar to that which occurs in asthma disorders that are associated with complex changes in the pathophysiology triggering breath control, possibly resulting in changes in air flow (V´). Considering the development "silent" changes of mechanical ventilation in COPD patients and its clinical relevance, as well as the difficulty of identifying such changes through conventional methods, we observed the need to obtain more detailed information, including the complexity of the system breathing for better understanding of factors that contribute to the illness. In this context, the objectives of this study were: (1) analyze the influence of airway obstruction in the complexity of the patterns of airflow in patients with COPD, (2) evaluate the diagnostic power of the test in identifying the changes caused by COPD.
The purpose of this study is to collect long-term safety data in participants with metachromatic leukodystrophy (MLD) who are receiving HGT-1110 and have participated in Study HGT-MLD-070 (NCT01510028) through Week 40.