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NCT ID: NCT02406755 Completed - Stress Clinical Trials

H-Senses Project - Self Care Mediated by the Senses

Start date: July 2014
Phase: N/A
Study type: Interventional

Randomized clinical trial about self-care mediated by the senses in female health professionals and their influence on stress, self-esteem, mood states, life satisfaction and levels of salivary cortisol.

NCT ID: NCT02406729 Active, not recruiting - Dengue Clinical Trials

Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine

Start date: February 22, 2016
Phase: Phase 3
Study type: Interventional

This is a randomized, multicenter, double-blind, placebo-controlled Phase III study that will evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine produced by Butantan Institute. The study will be carried out in multiple sites in Brazil. The study will be community-based in select urban areas where there's dengue transmission. Study's intervention will be a single dose of the tetravalent dengue vaccine or placebo in a ratio 2:1. For efficacy analysis will be considered all dengue cases occurring after 28 days post-vaccination in the entire population of 16944 participants. For safety analysis participants will be divided in three age groups: 18 to 59 ys, 7-17 ys and 2 to 6 ys. In each of these age groups there will be a minimum of 4992 participants. The age groups of 18 to 59 ys and 7 to 17 ys will start first. Once safety data for the first 21 days after vaccination is analysed for 450 participants in 7-to17-ys age group, the following group, of 2 to 6 ys, will start. The study's hypothesis is that the vaccine under investigation and produced by Butantan Institute is safe and provides protection against dengue symptomatic disease of 80% or more with a lower bound of the 95% confidence interval of 25%. This way, the expected number of dengue cases virologically confirmed is 24 or more which will provide a response in terms of vaccine efficacy. All participants will be followed up for five years to verify dengue incidence, regardless severity.

NCT ID: NCT02406638 Completed - Clinical trials for Urinary Incontinence

Pelvic Floor 3D USG Three Years After Mid-urethral Slings ( TVT-R, TVT-O, TVT-S)

Start date: April 2013
Phase: N/A
Study type: Observational

Compare through 3D USG the tape spatial orientation, in three different techniques of insertion of mid-urethral synthetic sling, correlating USG findings to postoperative results in an average of three years follow-up. Methods: This is a transversal study of a cohort women surgically treated for stress urinary incontinence by retropubic sling (TVT-R), transobturator sling (TVT-O) or single-incision sling (TVT-S). The clinical and USG evaluation were performed at the same medical visit, from April 2013 to June 2014, .

NCT ID: NCT02406339 Completed - Muscle Strength Clinical Trials

Effectiveness of NMES Associated to Vascular Occlusion in Functional Performance and Muscle Hypertrophy in Athlete's

Start date: July 2014
Phase: N/A
Study type: Interventional

This study evaluates the effect of training with neuromuscular electrical stimulation (NMES) associated with vascular occlusion of the lower limbs, for increased strength and hypertrophy of the quadriceps muscle of professional basketball athletes.

NCT ID: NCT02403323 Terminated - Crohn Disease Clinical Trials

Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144

JUNIPER
Start date: June 8, 2015
Phase: Phase 3
Study type: Interventional

This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.

NCT ID: NCT02401958 Completed - Clinical trials for Rheumatoid Arthritis

Acute Effect of Resistance Training in Inflammatory Markers in Women With Rheumatoid Arthritis

Start date: March 2014
Phase: Phase 4
Study type: Interventional

ABSTRACT Introduction: Rheumatoid arthritis (RA) is a systemic inflammatory, chronic and progressive disease that can lead to joint destruction and important functional disability. Chronic inflammation, with a substantial increase in the amount of pro-inflammatory cytokines in synovial joint, is one of the biggest challenges in controlling RA. Resistance exercise has been recognized for positively modulate inflammation in healthy subjects. Objective: To evaluate the effect of an acute bout of resistance exercise on serum concentrations of tumor necrosis factor alpha (TNF-α), interleukin 1 receptor antagonist(IL-1ra), interleukin 1 beta (IL-1β), C reactive protein (CRP), interleukin 6 (IL-6), interleukin 10 (IL-10), and cartilage oligomeric matrix protein (COMP) in postmenopausal women with RA and women without the disease. Methods: 17 volunteers with RA and 17 without the disease, with a mean age of 54.7 + 6.63 underwent a resistance exercise session with a set of 12 repetitions at 50% of one repetition maximum (1RM ) and a set of 8 repetitions at 75% of 1RM. The exercises performed were: knee extension, knee flexion, hip abduction and hip adduction. Blood samples were obtained 30 minutes before, 5 minutes before, immediately after, 1 hour, 2 hours and 24 hours after the exercise session. Serum glucose concentrations prior to exercise were also measured. The investigators used the Student's't test, the model of analysis of variance with repeated measures and Bonferroni method of multiple comparisons to analyze the data, being considered statistically significant levels of p <0.05.

NCT ID: NCT02401698 Suspended - Stroke Clinical Trials

Exploring Cerebellar Inhibition of the Motor Cortex in Stroke Patients

Start date: December 2014
Phase: N/A
Study type: Observational

The past 10 years of research in post stroke patients have shown certain types of rehabilitation can help neuronal plasticity of the brain. Transcranial magnetic stimulation (TMS) can be used to monitor this plasticity by mapping the brain's function (measuring brain activity). Recent research suggests that TMS can be used for both prognosis (determining future function) and to determine what type of rehabilitation therapy will work best after stroke. The purposes of this research study are to: 1) determine changes in cerebellar activity after motor cortical stroke 2) compare changes in recovery of motor function with changes in cerebellar - motor cortex connections; 3) determine the ability of TMS to "predict" functional outcome after stroke. The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure of motor threshold (MT), intracortical inhibition, cerebellar cerebral inhibition (CBI), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes.

NCT ID: NCT02401516 Completed - Hypertension Clinical Trials

Reprogramming Insoles In Regulating Blood Pressure In Hypertensive Subjects

RIBP
Start date: May 2014
Phase: N/A
Study type: Interventional

ASH has a high prevalence rates and considered one of the major modifiable risk factors for cardiac vascular diseases (CVD) and brain vascular diseases (BVD) and one of the most important public health problems. Researches estimated 62% of BVD can be attributed to ASH. In Brazil, prevalence of hypertension ranged from 21.6% in 2006 to 42.4% in 2011. CVD are responsible for high frequency of hospitalization, and in 2009, 91,970 hospitalizations due to CVD cost public treasury more than 165 million reais. ASH neurological pathophysiology studies has shown that excessive activation of sympathetic autonomic nervous system (SANS) seems to have an important role in genesis and maintenance of ASH, with current studies aimed to understand this relationship. Pathways used by SANS for immediate control of BP (wich are reticulate formation, bulb and cortex) appear to be similar to pathways used for postural control reflex (reticulate formation, bulb, cortex, among others), which are also used by Postural Reprogramming Insoles (PRI) for posture adequacy. Due to this similarity in reflex activation areas, it is believed that PRI may have some effect on BP regulation. There are many ways to treat postural changes and one of them is posturology, which is based on therapeutic use of postural reprogramming insoles (PRI). PRI activates tonic-postural system, rebalancing muscles, joints and bony structures of body segments, and returning individual to an appropriate posture. The PRI is composed of a central artifact, situated in reflex zone full of somatosensory stimuli captors, which generates a frequency of vibration that promotes postural adaptation.

NCT ID: NCT02400632 Completed - Clinical trials for Coronary Artery Disease

MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions

MAGIC-TOUCH
Start date: June 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy of MagicTouch DCB in reducing late lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary Angiography / Intravascular Ultrasound examination for the treatment of coronary artery lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.

NCT ID: NCT02400138 Completed - Stroke Clinical Trials

Home-based Respiratory Training After Stroke

Start date: February 2016
Phase: N/A
Study type: Interventional

Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training. This study will test the hypothesis that home-based combined training of the inspiratory and expiratory muscles is effective in improving strength of the inspiratory and expiratory muscles, endurance of the inspiratory muscles, dyspnea, walking capacity, and ocurrence of respiratory complications after stroke. For this clinical trial, people after stroke will be randomly allocated into either experimental or control/sham groups. The experimental group will undertake training of the inspiratory plus expiratory muscles with the Orygen Dual Valve device, regulated at 50% of the subjects' maximal inspiratory and expíratory pressure values, seven times/week over eight weeks during 40 minutes/day. The control group will undertake the same protocol, but the participants will receive the devices without resistance. At baseline, post intervention, and four weeks after the cessation of the intervention, researchers blinded to group allocations will collect the following outcome measures: maximal inspiratory and expiratory pressures, inspiratory endurance, dyspnea, walking capacity, and ocurrence of respiratory complications.