Trial In Brazil Research Articles

The impact of home fortification with multiple micronutrient powder on vitamin A status in young children: A multicenter pragmatic controlled trial in Brazil.

Home fortification with multiple micronutrient powder (MNP) is effective in the prevention of anemia in young children. However, the impact on their vitamin A status remains controversial. This study aimed to evaluate the effect of MNP on vitamin A status in young Brazilian children. A multicenter pragmatic, controlled trial was carried out in primary health centers in four Brazilian cities. In the beginning of the study, the control group (CG) consisted of children 11-14months old (n=395) attending in routine pediatric health care. In parallel, the intervention group (IG) was composed of children 6-8months old (n=399), in the same health centers, who followed the intervention with MNP for 2-3months. The analysis of the effect of MNP on vitamin A status was performed by comparing the IG with the CG after a 4- to 6-month follow-up when IG children had reached the age of the controls. The prevalence of vitamin A deficiency (VAD; serum retinol <0.70μmol/L) in the CG was 16.2%, while in the IG was 7.5%-a 55% reduction in the VAD [prevalence ratio (95% confidence interval)=0.45 (0.28; 0.72)]. This reduction was also significant when stratifying the study centers by coverage of the Brazilian Vitamin A Supplementation Program. The adjusted mean of vitamin A serum concentrations improved in the IG compared with CG children, with a shift to the right in the vitamin A distribution. Home fortification with MNP was effective in reducing VAD among young Brazilian children.

Exploring flow rate selection in HIPEC procedures.

Cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) has emerged as a main comprehensive treatment of peritoneal malignancies. However, current data on the literature are very heterogeneous in terms of its technical particularities, which require some efforts to standardization of practices. In these setting, we present some early data from a pioneering clinical trial in Brazil (ClinicalTrials.gov Identifier: NCT02249013) to explore the dynamic relationships between flow rates and temperature parameters in the first cases of our study, which may help in selecting better technical parameters during HIPEC procedures.

Impact of Child Feeding Training Program for Primary Care Health Professionals: A Cluster Randomized Field Trial in Brazil

Impact of Child Feeding Training Program for Primary Care Health Professionals: A Cluster Randomized Field Trial in Brazil

Wind dispersal of Puccinia psidii urediniospores and progress of eucalypt rust

SummaryTo identify and implement Puccinia psidii control strategies, it is essential to understand the role of environmental factors on rust‐disease development and spread among eucalypt (Eucalyptus spp.) plantations. In this study, we evaluated the wind dispersal of P. psidii urediniospores and the progress of eucalypt rust in a field trial in Brazil. Urediniospores of P. psidii were trapped in a Burkard® spore trap from July 2004 to June 2005. To evaluate the progress of eucalypt rust, plots were established in March 2002 using a clonal hedge scheme. The incidence of both branches and leaves with rust was assessed weekly from February 2003 to October 2005. Disease progress was studied using time‐series analysis. Urediniospores were trapped on 77% of the days sampled. The highest average urediniospore concentration was detected from July to November, and most of the urediniospores (58%) were trapped at night. Urediniospore concentration was negatively correlated with rainfall, light intensity, minimum, average and maximum temperatures and wind speed, whereas urediniospore concentration was positively correlated with leaf‐wetness duration and relative humidity. From December 2004 to June 2005, average urediniospore concentration was 0.22 spores m−3 air h−1 and had no correlation with meteorological data. The highest average urediniospore concentration was associated with a combination of low average temperature, low light intensity, low wind speed, high relative humidity and high leaf wetness, which reflect conditions observed at night. The disease incidence was positively correlated with the urediniospores trapped at 12 days prior to disease assessment. According to the models obtained by the time series, a seasonal yearly effect was found on rust progress. Using our models, we were also able to forecast disease incidence up to 3 months after the last field assessment.

Smoking and 2-month culture conversion during anti-tuberculosis treatment

To investigate risk factors for delayed sputum culture conversion to negative during anti-tuberculosis treatment, with an emphasis on smoking. Nested case-control study of adults with non-cavitary, culture-confirmed pulmonary tuberculosis (TB) participating in an anti-tuberculosis treatment trial in Brazil. A case of delayed culture conversion was a patient who remained culture-positive after 2 months of treatment. Odds ratios with 95% confidence intervals were calculated. Fifty-three cases and 240 control patients were analyzed. Smokers had three-fold greater odds of remaining culture-positive after 2 months of treatment (P = 0.007) than non-smokers, while smokers and ex-smokers who smoked >20 cigarettes a day had two-fold greater odds of remaining culture-positive after 2 months of treatment (P = 0.045). Cigarette smoking adversely affects culture conversion during anti-tuberculosis treatment. Support for smoking cessation should be considered to improve outcomes in TB control programs.

Cognitive Training for Schizophrenia in Developing Countries: A Pilot Trial in Brazil

Cognitive deficits in schizophrenia can massively impact functionality and quality of life, furthering the importance of cognitive training. Despite the development of the field in Europe and in the United States, no programmes have been developed and tested in developing countries. Different cultural backgrounds, budget restrictions, and other difficulties may render treatment packages created in high income countries difficult for adoption by developing nations. We performed a pilot double-blind, randomized, controlled trial in order to investigate the efficacy and feasibility of an attention and memory training programme specially created in a developing nation. The intervention used simple, widely available materials, required minimal infrastructure, and was conducted in groups. The sample included seventeen stable Brazilians with schizophrenia. Sessions were conducted weekly during five months. The cognitive training group showed significant improvements in inhibitory control and set-shifting over time. Both groups showed improvements in symptoms, processing speed, selective attention, executive function, and long-term visual memory. Improvements were found in the control group in long-term verbal memory and concentration. Our findings reinforce the idea that cognitive training in schizophrenia can be constructed using simple resources and infrastructure, facilitating its adoption by developing countries, and it may improve cognition.

Perillyl Alcohol for the Treatment of Temozolomide-Resistant Gliomas

Perillyl alcohol (POH) is a monoterpene that has been used orally for the treatment of systemic cancer. However, when used orally significant gastrointestinal side effects and lack of overall efficacy were documented. Recently, in a phase II trial in Brazil for the treatment of temozolomide (TMZ)-resistant malignant gliomas, POH was well tolerated when administered intranasally. The present study explores the effects and mechanisms of POH on TMZ-sensitive and TMZ-resistant glioma cells. In vitro studies showed that POH was cytotoxic to TMZ-resistant as well as TMZ-sensitive glioma cells, and this effect was independent of O(6)-methylguanine-DNA methyltransferase expression. POH induced cytotoxicity, in part, through the endoplasmic reticulum (ER) stress pathway as shown by the increased expression of glucose-regulated protein-78 (GRP78), activating transcription factor 3, and C/EBP-homologous protein. In addition, POH impeded survival pathways, such as mTOR and Ras. As well, POH reduced the invasive capacity of sensitive and resistant glioma cells. POH alone and/or in combination with other ER stress-inducing cytotoxic drugs (i.e., 2, 5-dimethyl-celecoxib, nelfinavir) further induced apoptosis in TMZ-sensitive and TMZ-resistant glioma cells. To show whether intranasal delivery of POH was effective for the treatment of TMZ-resistant gliomas, animals bearing intracranial tumors were given POH intranasally. Animals treated through intranasal administration of POH exhibited a decrease in tumor growth and an increase in survival. Our data show that POH is an effective anti-glioma cytotoxic agent for TMZ-resistant gliomas when administered intranasally.

Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study

There is a high demand for stroke rehabilitation in the Brazilian public health system which should make undertaking clinical trials straightforward. The aims of this study were to 1) determine the rate of recruitment of community-dwelling stroke survivors into a randomized trial of the effects of strength training in addition to task-specific gait training, 2) compare the effectiveness of various recruitment strategies on accrual rates, and 3) determine the attendance at training sessions and adherence to the intervention protocol. Participants within six months of a stroke were screened for eligibility and invited to participate. Recruitment strategies were classified as advertisement or referral. The number of people who were screened, eligible and recruited for each strategy was recorded. Attendance at training sessions and adherence to the intervention protocol were recorded. Over the first 14 months, 150 stroke survivors were screened, 10 were recruited, and 35 (23%) were eligible. Twenty-five of these patients (71%) were unable to participate with lack of transport given as the most common reason. The most successful strategy was referral via hospital-based physical therapists (50%). Overall attendance was 72% with lack of transport being the most common reason for non-attendance. Overall adherence to the protocol was 97% with feeling unwell being the most common reason for non-adherence. Recruitment of stroke survivors was inefficient. Lack of transport was the most common barrier to participate in and attend training sessions. Funding for transport is essential to make carrying out trials in Brazil feasible. Trial Registration ACTRN12609000803291.

Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study

Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study

Challenges and Implemented Solutions for the Oral Cleft Prevention Trial in Brazil

The Oral Cleft Prevention Program (OCPP) is a double-blind, randomized, two-arm multi-site clinical trial designed to assess the effect of periconceptional daily folic acid supplementation (4.0 mg vs. 0.4 mg) on the recurrence of cleft lip, with or without cleft palate, among women with elevated risk. Conducted in seven sites in Brazil, the OCPP randomized 2,510 women in the trial (1,257 to the 4.0 mg group, and 1,253 to the 0.4 mg group). A Data Coordinating Center (DCC), located in the United States, is responsible for the trial's statistical design and analysis, data collection system, data management and storage, activity coordination, data quality control, and site training. DCCs of international trials, such as the OCPP, face unique implementation challenges due to de-centralized organization. The objective of this paper is to describe these challenges and to present the innovative solutions developed to address them.

Terapia gênica para cardiopatia isquêmica

Severe ischemic heart disease with refractory angina, occurs in increasing incidence. Alternative forms of treatment, in an attempt to reduce myocardial ischemia and relief of symptoms has been studied. In this context, gene therapy is an option, for the possibility of inducing angiogenesis, establish collateral circulation and reperfuse ischemic myocardium. Several clinical trials have been conducted and, except for specific cases of adverse effects, there is indication of safety, feasibility and potential effectiveness of therapy. The clinical benefit, however, is not yet well established. In this article we review the clinical trials of gene therapy for patients with ischemic heart disease. The approach includes: (1) myocardial ischemia and angiogenesis on the pathophysiological aspects involved, (2) growth factors, dealing with specific aspects and justifying the use in cardiac patients with no option for conventional therapy, (3) controlled clinical trials, where a summary of the main studies involving gene therapy for severe ischemic heart disease is presented, (4) our experience, especially on preliminary results of the first gene therapy clinical trial in Brazil and (5) future prospects.

Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study

Challenges in recruitment, attendance and adherence of acute stroke survivors to a randomized trial in Brazil: a feasibility study

Yoga respiratory training improves respiratory function and cardiac sympathovagal balance in elderly subjects: a randomised controlled trial

ObjectivesSince ageing is associated with a decline in pulmonary function, heart rate variability and spontaneous baroreflex, and recent studies suggest that yoga respiratory exercises may improve respiratory and cardiovascular function,...

General hospital admission as an opportunity for smoking-cessation strategies: a clinical trial in Brazil

Objective To compare the results of 6-month follow-ups for hospitalized patients who were divided into two groups of low- and high-intensity treatments for smoking cessation and compared to the results of standard hospital treatment. Methods A total of 2414 patients were screened. Two hundred thirty-seven current smokers were randomly assigned to high-intensity intervention (HII; 30-min motivational interview plus seven routine telephone calls after hospital discharge) or to low-intensity intervention (LII; 15-min counseling about the benefits of quitting) and 80 comprised the usual care (UC) group. Six months after hospital discharge, all participants were contacted by phone. The main outcome measure was smoking cessation. Results The smoking-cessation rates were 44.9%, 41.7% and 26.3% for the HII, LII and UC groups, respectively ( P = .03). The multivariable analysis identified the following variables which are associated with the failure to stop smoking: the absence of a tobacco-related disease (TRD), younger age and a low motivation for cessation at the initial contact. Conclusions There was a great difference between intervention and nonintervention. The LII had an impact similar to the HII. The variables associated with no smoking cessation demonstrate the need for more personalized interventions for smokers who present lower indexes of motivation, are younger and do not have smoking-related diseases.

Iron-Fortified Rice Is As Efficacious As Supplemental Iron Drops in Infants and Young Children

How to improve iron status among infants and young children is of continued concern in low- to middle-income countries, including Brazil. In a double blind, 5-mo, home-based, randomized trial in Brazil, we gave one group of mildly anemic 6- to 24-mo-old children (n = 175) rice fortified with micronized ferric pyrophosphate using the Ultra Rice technology and a placebo solution (URG) and another group identical nonfortified rice and iron drops. We instructed parents on the correct dosage of iron drops and to feed their children rice as they normally would. We measured serum ferritin (SF) and hemoglobin (Hb) concentrations at baseline and at 5 mo. At baseline, the prevalences of iron deficiency and anemia in the total sample were 73.1 and 100%, respectively. At 5 mo, SF and Hb increased in both groups, although the change in the URG was larger (P < 0.01). Adult participants were unable to distinguish cooked fortified rice from unfortified rice in terms of smell, color, or taste. As rice is normally consumed at home, MPF-fortified rice increased iron stores and reduced anemia in a group of mildly anemic children 6–24 mo old. In populations where young children are routinely fed ∼100 g of cooked rice daily, fortifying it with iron may improve iron status at least as well as providing free iron drops.

Estimation of vaccine efficacy in a repeated measures study under heterogeneity of exposure or susceptibility to infection

Vaccine efficacy (VE) is commonly estimated through proportional hazards modelling of the time to first infection or disease, even when the event of interest can recur. These methods can result in biased estimates when VE is heterogeneous across levels of exposure and susceptibility in subjects. These two factors are important sources of unmeasured heterogeneity, since they vary within and across areas, and often cannot be individually quantified. We propose an estimator of VE per exposure that accounts for heterogeneous susceptibility and exposure for a repeated measures study with binary recurrent outcomes. The estimator requires only information about the probability distribution of environmental exposures. Through simulation studies, we compare the properties of this estimator with proportional hazards estimation under the heterogeneity of exposure. The methods are applied to a reanalysis of a malaria vaccine trial in Brazil.

Intergenerational interaction, social capital and health: Results from a randomised controlled trial in Brazil

Recent years have seen a burgeoning of intergenerational programmes aiming to improve the well being of participants. However, very few programmes have been formally evaluated. In this paper we report results from a randomised controlled trial of a school-based intergenerational intervention undertaken in Brazil. Randomly selected samples of 253 adolescents and 266 elders aged 60 and over resident in the school's catchment area were administered a questionnaire including questions on cognitive components of social capital, family relationships, and self-rated health. Participants were then randomly allocated to control and intervention groups. The intervention comprised participation in a 4 month programme of intergenerational activities in which the elders shared their memories with the students. At the end of the intervention the questionnaire was re-administered to the samples. High proportions (85–95%) of both samples completed the questionnaires but compliance with the intervention was low in the elderly group. In the analysis of results from the elderly sample, we therefore compared the control group with the group assigned to the intervention (intention to treat analysis). Results showed that adolescents in the intervention group were nearly three times more likely to rate their health as good than those in the control group, but also more likely to judge that most people were selfish. In the elderly sample, those from the intervention group were over twice as likely as those from the control group to report positively on the helpfulness of neighbours; judge most people to be honest or consider their family relationships as good. There were no significant differences between groups on other outcome measures. These results suggest that structured intergenerational activities may have positive effects on some aspects of social capital for both adolescents and elderly people, although further research is needed to elucidate the processes involved and the extent to which the findings are context specific. This study is the first to use a controlled trial design to evaluate this type of intervention and is valuable in showing that this design can be used in interventions of this kind, and also the difficulties involved.

Field trial of the efficacy of a combination of imidacloprid and permethrin against Tunga penetrans (sand flea, jigger flea) in dogs in Brazil

In a field trial in Brazil 17 dogs penetrated by females of the jigger flea, Tunga penetrans, were topically treated with a combination of 10% imidacloprid and 50% permethrin (Advantix), while 17 dogs remained untreated. The follow-up controls on days 7, 14, 21 and 28 post-treatment clearly showed that, beginning from day 7, the flea load in treated dogs decreased, so that most of the dogs became free of tungiasis lesions, while in the untreated group the flea load remained high. Since the dogs distribute the flea eggs throughout the village, leading to a high incidence of tungiasis in humans, treatment of dogs probably also decreases the number of cases of tungiasis in the latter.

Law and the Image of a Nation: Religious Conflict and Religious Freedom in a Brazilian Criminal Case

This article examines a criminal trial in Brazil that touched on the imagined role of religion in public life. The case involved a Protestant minister accused of religious discrimination and of vilipending an image of Nossa Senhora Aparecida, the patron saint of Brazil. The prosecution argued and the court concurred that the minister's iconoclastic verbal and physical gestures endangered the constitutional guarantee of religious freedom. Yet the defense claimed that his actions, stemming from his religious convictions, expressed this same principle of freedom. Different visions of religious free-dom are at stake in the case as well as how such freedom relates to the rights and private lives of citizens. Placed in the history of church-state relations in Brazil, the case raises the problem of interpreting concepts of religious pluralism, religious freedom, and freedom of expression in Brazilian law.

Interventions for preventing reactions to snake antivenom.

Antivenom is used to neutralise snake bite toxins in people showing evidence of envenomation. It is made from animal sera, and adverse effects, including life threatening anaphylaxis, are common. To assess the effects of drugs given routinely with snake antivenom to prevent adverse effects. Cochrane controlled trials register; contact with researchers in the field. Randomised and quasi-randomised trials testing routine adrenaline (epinephrine), antihistamines, or corticosteroids. The two authors applied the inclusion criteria, assessed trial quality, and extracted the data. We sought additional data from trialists where required. One trial in Sri Lanka (n = 105) giving adrenaline with polyspecific antivenom showed fewer adverse reactions in the adrenaline group, and this effect was preserved when stratified for severity. One trial in Brazil (n = 101) using three types of Bothrops antivenom showed no benefit of antihistamine drugs. Routine prophylactic adrenaline for polyvalent antivenom known to have high adverse event rates seems sensible, based on this one trial. If clinicians believe local factors do not justify routine adrenaline, then they should test their belief in a randomised trial. Antihistamine appears to be of no obvious benefit in preventing acute reactions from antivenoms.