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 evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, delivered via a popular texting platform. For this pilot project, the program content is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children demonstrating behavior consistent with ADHD and experiencing difficulties with daily transition routines are invited to participate in the study.
Introduction: Prematurity refers to babies born before 37 weeks of gestation that through technological advances survival is increasing, since most of them are referred to the Neonatal Intensive Care Unit (NICU). Hemodynamic monitoring is of fundamental importance in the care provided to critically ill patients and mechanical ventilation (MV) is often used for the recovery and maintenance of newborns, especially premature infants with any pathology that causes cardiorespiratory failure. Considering this, it is necessary to look for ways to treat these newborns (NB), being the therapeutic positioning one of the simplest and most fundamental to reduce the consequences of the mechanical advantages of the respiratory system of newborns. Objective: To evaluate the hemodynamic repercussions in the various therapeutic positions in premature newborns under invasive mechanical ventilation. Method: A field study to be conducted will be randomized on an experimental, quantitative and descriptive character. It will be developed at the Santa Casa de Misericórdia do Pará Foundation (FSCMPa), in the Neonatal Intensive Care Unit. The population to be evaluated will be preterm infants with gestational age ≤37 weeks, on invasive mechanical ventilation, with no congenital malformations, with the diagnosis of intracranial hemorrhage and that those responsible, after being informed, authorized to participate in the research. Being excluded the preterm infants without legal companion, who are affected by any unfavorable clinical condition, which makes the change of unfeasible position, children with neuromuscular diseases, tracheostomized. A sample will be randomly selected in groups: Prono Group (GP), Supine Group (GS) and Lateral Decubitus Group (GDL). The decubitus to be adopted for each research subject will then be registered by the researcher in a specific form, recording as respiratory cardiological responses: respiratory rate (RR), heart rate (HR) and peripheral oxygen saturation (SPO2), temperature (T) and pressure blood pressure (BP). Such clinical responses will be noted prior to NB positioning, then positioned according to the group to which they will belong for 30 minutes, and then there will be another selection of vital signs.
Patient-ventilator asynchronies can occur as a result of a mismatch between neural (patient) and ventilator inspiratory and expiratory phases. Sensitivity of this visual analysis, even when performed by experts in the field, is low, around 28% in one landmark publication. The impact of the display of Pmus together with the other ventilator waveforms on the ability of health-care professionals to identify asynchronies has not been tested so far. OBJECTIVES: To compare the sensitivity and specificity of the detection of patient-ventilator asynchrony by health professionals through visual inspection of the ventilator waveforms (conventional group) with the sensitivity and specificity of health professionals who have available, in addition to these ventilator waveforms, also the estimated inspiratory muscle pressure curve (Pmus group). METHODS: Participants will analyze 49 consecutive different scenarios of mechanical ventilation generated in a simulator. Intensive care unit physicians and respiratory therapist will be invited to participate and after the inclusion will be randomized to one of two groups: 1) the control group will inspect pressure and flow curves and 2) the Pmus group will inspect pressure, flow, and Pmus curves. Before the start of the study, all participants will have a 30-min training session to homogenize their concepts on the definitions of the different types of asynchrony. Subsequently, the participants will be randomized to the conventional group or Pmus group. Participants will be designated to watch different sessions, in groups of at most 20 individuals, according to their randomization. In these sessions, recorded ventilator waveforms will be projected to a large screen for 30 seconds. A still image containing a few ventilatory cycles will remain visible for another 30 seconds when participants will have to choose which asynchrony (if any) the participants can see on the screen. Sessions of the Pmus group will display, in addition to pressure and flow, the estimated muscle pressure curves. The main outcome is the asynchrony detection rate (sensitivity). It will be also compared specificity, positive and negative predictive values for asynchrony detection. Statistical significance will be set at an alpha level of 0.05. The sample size was estimated in 98 participants based on the expectation of a 10 percentage points difference in the sensitivity between groups.
The literature recognizes that fluoride is the most widely used and studied means for dental remineralization. The use of fluoride mouthwashes is shown as an effective way to increase the fluoride intraoral availability. However, the current challenge is the substantivity, so new compounds have been introduced into these formulations. This study aims to evaluate the in vivo effect of fluoride mouthwash containing nanoencapsulated Fluoride (NanoF) - in fluoride retention in saliva and dental plaque. A study of the clinical and laboratory type, crossover, double-blind, randomized will be held. After sample calculation, the total of 12 individuals aged between 18 and 35 years old, healthy, decayed, missing, and filled teeth index less than 6 and residents in brazilian northeast capital will be part of the sample. Fluoride bioavailability will be evaluated in the biofilm and saliva after the use of fluoridated weekly. The biofilm will be assessed on 1h and 12 h after rinsing; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after. It will be 3 mouthwashes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride and Free sodium fluoride. Between weeks of use, rinsing will be extended washout (without fluoride) to avoid carryover effect. Inferential data analysis will be carried out, considering the amount of alpha <0.05. So knowing that caries is a dynamic process, the largest fluoride retention in the oral fluids promoted by the Nanoencapsulated Fluoride may have important impact on Des-Re process and in the control of dental caries.
The aim of the study is to develop an herbal gel based on Acmella oleracea and do a comparative analysis to evaluate the intensity of pain during the digital rectal examination comparing to lidocaine gel group and ultrasound gel group.
OBJECTIVE: To evaluate in vivo the efficacy of fluoride-containing dentifrice incorporated in a controlled-release system (F-CSL, patent pending) in the remineralization of white spot lesions of caries in caries-active individuals. METHODS: A double-blind randomized clinical trial to evaluate the bioavailability of intraoral fluoride in biomarkers of exposure (biofilm and saliva) after the use of experimental toothpaste in the control of dental caries. The study will last three months. The participants of the study will be divided into three groups according to the dentifrice used. The sample will be selected randomly and composed of children and adolescents who seek the service of cariology of the UFPB. There will be participants of both sexes, preferably of the metropolitan region of João Pessoa in order to guarantee the low fluorine exposure by the water of supply. Intrabucal photographs will be obtained. Samples of saliva will be collected after 3 hours of the last meal. The benefits will be achieved by obtaining the reduction of the white spot area (mm2) plus the fact that all the children will be examined and will receive information on the treatment needs and forwading for the same.
Investigators developed a brief standardized internet-delivered cognitive-behavioral program for treating anxious and depressive symptoms in children and adolescents in the context of COVID-19 pandemics in Brazil. A 2-arm parallel-randomized controlled clinical trial will be conducted to test the efficacy of this program (intervention group), in comparison with a educational-only intervention program based on videos (active control group). 280 children and adolescents (8 to 17 years-old) with clinically significant anxious and/or depressive symptoms will be recruited through internet and social media. They will be randomized either to the intervention (n=140) or active control group (n=140). Participants will be recruited from across the country. The therapeutic program consists of 5 weekly sessions covering the following contents: education on stress reactions, family communication, relaxation and mindful techniques, emotion recognition, management of irritability, behavioral activation, and cognitive restructuring. The educational program consists of 15 videos covering the same content. Participants in the intervention group will also have access to these videos. Both child/adolescent and at least one caregiver will be required to take part in the sessions (and watch the videos). Participants will be assessed at the beginning (baseline; T0) at the end (endpoint; T1), and 30 days after the intervention (follow-up; T2) with standardized questionnaires, through an interview with a blinded investigator. Participants that develop severe symptomatology requiring further support during the intervention (such as psychiatric pharmacological treatment and/or more intensive psychotherapy) will be referred to adequate treatment. During the week prior to the intervention and the first week after its end, adolescents (older than 12 years-old) in both groups with access to a smartphone will be asked to report their momentary mood, emotions, and stress several times a day using the same smartphone app that will deliver the educational content to both groups. Adolescents will also be asked to install a second smartphone application that captures data from the phone sensors to provide proxies on behaviors associated with depression, such as social isolation (by the proximity with other devices, time spent on social media, as well as environmental sound and light) amount of inactivity (by assessing the maximum distance traveled throughout the day), among others.
The prevalence of Obstructive Sleep Apnea (OSA) is high in individuals after a stroke. There are few studies evaluating the effects of inspiratory muscle training (IMT) in individuals with OSA and the findings regarding the possible effect on Apneia/Hipopneia Index (AHI) reduction are still controversial. This study will test the hypothesis that training of the inspiratory muscles is effective in improving severity of OSA, sleep quality and daytime sleepiness in individuals after stroke participating in a rehabilitation program. Methods: For this prospective, sigle blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over five weeks 5 sets of 5 repetitions with 1 set increasing each week. Both groups will participate in the rehabilitation program and will receive the same dose of physiotherapy, speech therapy and aerobic exercise sessions. At baseline and post intervention after the cessation of the interventions, researchers blinded to group allocations will collect all outcome measures. Study outcomes: Primary outcome will be OSA severity measured using the Apnea/Hypopnea Index (AHI). Secondary outcomes will include inspiratory endurance and pressure, functional independence, sleep quality and daytime sleepiness
The purpose of this study is to investigate the efficacy of proxalutamide or hospitalized moderate-to-severe COVID-19 patients.
The purpose of this study is to evaluate the topical safety (tolerability/acceptability) of a kit of cosmetic products (shampoo, conditioner, and combing cream), the presence of residues on the scalp through visual assessment and image capture, the skin barrier, pH, and sebum level. All these evaluations will be performed before and after 28 plus minus (+-) 2 days of use under normal conditions, under the supervision of dermatologist and pediatrician.