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.
Elderly have a high prevalence to systemic arterial hypertension (SAH) and obstructive sleep apnea (OSA). Both comorbidities are closely associated and inflict injury cardiorespiratory capacity. To assess cardiorespiratory responses to the cardiopulmonary exercise test (CPET) among hypertensive elderly with OSA. We enrolled 25 elderly hypertensive in two different groups: without OSA (No-OSA: Apnea/Hypopnea Index (AHI) < 5 events/h; n = 15) and with OSA (OSA: AHI ≥ 15 events/h; n = 13). All subjects underwent a CPET and polysomnographic assessments. After normality and homogeneity evaluations, independent t test and pearson's correlation were performed. The significance level was p ≤ 0.05.
The aim of the present study was to assess the influence of different volumes of Pilates training exercises on metabolic, blood pressure (BP), functional physical fitness (PF) and quality of life (QL) outcomes in postmenopausal dyslipidemic women. In total, 26 women participated in the controlled clinical trial, being allocated into three groups: high volume group (HVG; n=9), low volume group (LVG; n=11) and control group (CG, n=6). HVG performed four weekly sessions and LVG performed only twice a week, during 10 weeks with 45 to 55 minutes per session. Before and after the intervention period, metabolic, BP, PF, QL and cardiovascular risk score (CRS) outcomes were measured. The results were described by mean values with lower and upper limits (95% confidence interval). Comparisons between groups and intra-groups were performed adopting Generalized Estimating Equations (GEE) method, with post hoc of Bonferroni and significance level of ɑ=0,05.
The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC). Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.
This is an open-label extension study to Study 200622.In this study subjects from Study 200622 will be continued on 4-weekly dosing with open-label mepolizumab 300 milligram (mg) subcutaneously (SC) for an additional 20 Weeks after completing the 32 Week study assessments post-randomization, while they continue with their background HES therapy per standard of care (SoC). Subjects from study 200622 will participate in this extension study if they had completed the 32-Week treatment period in study 200622 or if they were withdrawn from the study pre-maturely, but were continued in the study per protocol until 32 Weeks from randomization. Data from this study (205203) and 200622 will be combined to provide up to 52-Week exposure data to further characterize the long-term safety profile of mepolizumab and provide additional data on the clinical benefit in HES subjects beyond 32 Weeks. The duration of the study participation will be 20 Weeks for subjects who continue with mepolizumab treatment via MHE104317/MHE112562 after this open-label extension study; and 28 Weeks for subjects who do not continue with MHE104317/MHE112562.
The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo. With Amendment 6 (effective date: 11-Dec-2020), active participants, investigator, and sponsor personnel or delegate(s) involved in the treatment administration or clinical evaluation of the participants will be unblinded. Participants will discontinue ipilimumab and placebo and participants who remain on treatment will receive open-label pembrolizumab only.
Introduction: Prematurity rate has increased and is a risk factor for developmental delay. Preterm infants with low visual tracking might present deficits in cognition, language, and fine motor function in future ages. Few studies applied home stimulation of the visual system for preterm infant (PT) at an early age. Objective: To compare the effects of early visual stimulation to a standard care group in visual function, motor and sensory development. Methods: Randomized controlled trial. At home setting. Thirty healthy preterm infants, gestational age from 28 to 37 weeks, aged from one to two months of corrected age at the entrance of the study, with low visual function, will be evaluated. Participants will be randomly allocated to: (1) a standard care group, receiving orientation about general sensory and motor development, (2) an early visual stimulation group receiving a 4-week home based protocol applied by caregivers additional to standard care. Outcomes will be measured at before the beginning of stimulation, at the end of stimulation and at 6 months of corrected age. Primary outcome is visual function evaluated by ML Leonhardt Battery of Optotypes. Secondary outcomes include motor and sensory development evaluated by scales.
Introduction: The level of physical activity decreases progressively with age. Elderly subjects who are physically active have lower rates of morbidity and mortality when compared to those inactive. Hospitalization leads to long periods of bed rest and physical inactivity, with consequent muscle atrophy, generalized weakness, and decreased independence and functionality. Therefore, preventing inactivity, loss of muscle strength and the worsening of functional performance during hospitalization may be a way to avoid loss of independence. And while movement has been increasingly promoted as an important part of the recovery of hospitalized patients, many of them still spend much of the time bedridden while in hospital. Objectives: To evaluate the impact of a guiding program on the importance of remaining active during hospitalization in relation to the level of physical activity, functionality and muscular strength of elderly patients and to identify the main barriers that impede them to perform physical activities in the hospital environment. Methods: Randomized and controlled trial which will include elderly patients admitted to the Respiratory Diseases and Medical Clinic wards of the Institute of Medical Assistance to State Public Servants, in São Paulo. The intervention group will receive verbal guidelines and one booklet on the deleterious effects of hospitalization and the importance of staying active during hospitalization. All patients will be evaluated through accelerometry to identify the level of physical activity during hospitalization. Functionality will be evaluated through the DEMMI scale, muscular strength through handgrip and the main barriers to stay active during hospitalization by applying a questionnaire. The days of hospitalization and the clinical complications presented by the patients during the stay in the hospital will be noted. The difference of the outcomes of the level of physical activity and functionality before and after the intervention will be compared between the control and the intervention group through a t-test. The length of hospital stay will be analyzed by the Kaplan-Meier test and the incidence of complications by the chi-square test.
Kinesio taping (KT) has been commonly used in rehabilitation in children with Unilateral Cerebral Palsy (UCP). However, there is a lack of studies that verified the effects of KT in CP. We aimed to verify the effects of KT in the performance of sit to stand movement (STS) in children with spastic UCP (USCP). A blinded, placebo and repeated-measure design was applied. The setting was the rehabilitation clinic of the university and care facilities. Eleven children, aged from 6 to 12 years old (10.5±-2.8 years), diagnosed with USCP, Gross Motor Function Classification System levels I and II were evaluated. KT was applied over rectus femoris (RF) muscle of the affected limb. We considered three taping conditions: KT, without KT (with tension) and placebo (KT without tension). Mean root mean square (mRMS) of RF; initial, final and peak angles, and range of motion of trunk, pelvis, hip, knee and ankles joints; and total duration of STS were considered. STS was evaluated from three seat heights, neutral (100%), lowered (80%) and elevated (120%). Mixed ANOVA test was applied for angular variables of hip, knee and ankle, and mRMS of RF. Repeated ANOVA was applied for angular variables of trunk and pelvis, total duration.
This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group, equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel) in subjects with Stage IIIB/IV non-squamous NSCLC
This randomized, crossover sham controlled trial with sham intended to study the effect of electrical stimulation on peripheral nerve (spinal accessory nerve) with acupuncture needle in healthy subjects aims to access the effect o electrical stimulation of accessory spinal nerve in cortical activation, muscular perfusion and autonomic response in healthy subjects. Participants will be assessed through measure changes in cortical activation, local muscular peripheral perfusion and autonomic responses before and after intervention and intervention-sham, and crossed after a period of wash-out. The design aims to contribute to assessment of one electroacupuncture's techniques by measuring some of the physiological effects caused by peripheral stimulation.