A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): Study protocol for a randomized double-blind controlled trial

Background: Cardiovascular disease is the leading cause of death in Brazil, and hypertension is its major risk factor. The benefit of its drug treatment to prevent major cardiovascular events was consistently demonstrated. Angiotensin-receptor blockers (ARB) have been the preferential drugs in the management of hypertension worldwide, despite the absence of any consistent evidence of advantage over older agents, and the concern that they may be associated with lower renal protection and risk for cancer. Diuretics are as efficacious as other agents, are well tolerated, have longer duration of action and low cost, but have been scarcely compared with ARBs. A study comparing diuretic and ARB is therefore warranted.Methods/design: This is a randomized, double-blind, clinical trial, comparing the association of chlorthalidone and amiloride with losartan as first drug option in patients aged 30 to 70 years, with stage I hypertension. The primary outcomes will be variation of blood pressure by time, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new subclinical atherosclerosis and sudden death. The study will last 18 months. The sample size will be of 1200 participants for group in order to confer enough power to test for all primary outcomes. The project was approved by the Ethics committee of each participating institution.Discussion: The putative pleiotropic effects of ARB agents, particularly renal protection, have been disputed, and they have been scarcely compared with diuretics in large clinical trials, despite that they have been at least as efficacious as newer agents in managing hypertension. Even if the null hypothesis is not rejected, the information will be useful for health care policy to treat hypertension in Brazil. Clinical trials registration number: ClinicalTrials.gov: NCT00971165. © 2011 Fuchs et al; licensee BioMed Central Ltd.

Erythromycin versus neomycin in the treatment of hepatic encephalopathy in cirrhosis: A randomized double-blind study

Background: Hepatic encephalopathy (HE) is a severe complication in patients with hepatic cirrhosis, which causes numerous hospital admissions and deaths. Antibiotics are the best options in HE treatment, but head-to-head comparisons between these drugs are scarce. Erythromycin combines the antimicrobial effect and prokinetic properties in the same drug, but it has never been used in HE treatment. Our aim was to evaluate the efficacy of erythromycin as an HE treatment.Methods: We achieved a randomized controlled trial of adult patients with HE and hepatic cirrhosis admitted in our hospital. After randomization, the subjects received either erythromycin 250 mg or neomycin 1 g orally QID until hospital discharge or prescription of another antibiotic. All subjects were blindly evaluated every day towards quantifying clinical, neuropsychometric, hepatic and renal exams. Statistical analysis was employed to compare the groups and correlate the variables with hospitalization duration.Results: 30 patients were evaluated (15 treated with each drug). At hospital admission, the groups were homogeneous, but the erythromycin group subjects achieved a shorter hospitalization stay (p = 0.032) and a more expressive reduction in alanine aminotranspherase levels (p = 0.026). Hospitalization duration was positively correlated with C reactive protein levels measured previous to (p = 0.015) and after treatment (p = 0.01).Conclusions: In the sample evaluated erythromycin was associated with significant reductions in hospital stay and in alanine aminotranspherase values. Hospitalization time was positive correlated with C reactive protein levels measured before and after the treatments. © 2013 Romeiro et al.; licensee BioMed Central Ltd.

Double-blind comparison of rectally administered diazepam to placebo for pediatric sedation: the cardiovascular response.

The sedative and cardiovascular effects of rectally administered diazepam (0.6 mg/kg) were compared to placebo in uncooperative children who required sedation during dental treatment. Twelve healthy preschool children, who required amalgam restorations, were treated during two standardized restorative appointments in a double-blind, crossover study. Blood pressure and pulse were obtained during four specified intervals during the appointment. The behavior of the children during the treatment visits was videotaped and later statistically analyzed using a kinesics/vocalization instrument. Behavioral ratings of cooperation were significantly improved during the treatment visit following diazepam. All interfering bodily movements, patient vocalizations and operator commands for the diazepam group were reduced significantly (p≤0.0001). No significant differences were observed for noninterfering behavioral response. Rectally administered diazepam did not alter blood pressure or pulse significantly in these sedated children when compared to the placebo. These findings indicate that rectal diazepam is an effective sedative agent with minimal effect on the cardiovascular system for the management of the young pediatric dental patient.

A randomized, double-blind, placebo-controlled pilot study of naltrexone in outpatients with bipolar disorder and alcohol dependence.

BACKGROUND: Alcohol dependence is extremely common in patients with bipolar disorder and is associated with unfavorable outcomes including treatment nonadherence, violence, increased hospitalization, and decreased quality of life. While naltrexone is a standard treatment for alcohol dependence, no controlled trials have examined its use in patients with co-morbid bipolar disorder and alcohol dependence. In this pilot study, the efficacy of naltrexone in reducing alcohol use and on mood symptoms was assessed in bipolar disorder and alcohol dependence. METHODS: Fifty adult outpatients with bipolar I or II disorders and current alcohol dependence with active alcohol use were randomized to 12 weeks of naltrexone (50 mg/d) add-on therapy or placebo. Both groups received manual-driven cognitive behavioral therapy designed for patients with bipolar disorder and substance-use disorders. Drinking days and heavy drinking days, alcohol craving, liver enzymes, and manic and depressed mood symptoms were assessed. RESULTS: The 2 groups were similar in baseline and demographic characteristics. Naltrexone showed trends (p < 0.10) toward a greater decrease in drinking days (binary outcome), alcohol craving, and some liver enzyme levels than placebo. Side effects were similar in the 2 groups. Response to naltrexone was significantly related to medication adherence. CONCLUSIONS: Results suggest the potential value and acceptable tolerability of naltrexone for alcohol dependence in bipolar disorder patients. A larger trial is needed to establish efficacy.

Wind-induced loads over double cantilever bridges under construction

Within the last century the interest in wind-induced loads over civil engineering structures has become more and more important, the reason being that the development of new construction techniques and materials has allowed engineers and architects to design new structures far from the traditional concepts, and in many cases wind actions over these singular structures are not included in the existing codes of practice. In this paper the windinduced static loads over bridges constructed by the double cantilever method during erection stages are considered. The aerodynamic load over a double cantilever bridge under a yawing-angled wind produces a yawing (torsional) moment on the bridge deck, which can lead to undesirable rotation of the deck about the supporting pier. The effects of the wind yaw angle and the length of the deck are analysed. The wind action caused by the presence of sliding concrete forms at the ends of the deck is also studied.

PENTAZOCINE VERSUS PENTAZOCINE WITH RECTAL DICLOFENAC FOR POSTOPERATIVE PAIN RELIEF AFTER CESAREAN SECTION- A DOUBLE BLIND RANDOMIZED PLACEBO CONTROLLED TRIAL IN A LOW RESOURCE AREA.

BACKGROUND: The unimodal approach of using pentazocine as post-cesarean section pain relief is inadequate, hence the need for a safer, easily available and more effective multimodal approach. AIM: To evaluate the effectiveness of rectal diclofenac combined with intramuscular pentazocine for postoperative pain following cesarean section. METHODS: In this double blind clinical trial, 130 pregnant women scheduled for cesarean section under spinal anesthesia were randomly assigned to two groups. Group A received 100mg diclofenac suppository and group B received placebo suppository immediately following surgery, 12 and 24h later. Both groups also received intramuscular pentazocine 30mg immediately following surgery and 6 hourly postoperatively in the first 24 h. Postoperative pain was assessed by visual analogue scale at end of surgery and 2, 12 and 24 h after surgery. Patient satisfaction scores were also assessed. RESULTS: One hundred and sixteen patients completed the study. Combining diclofenac and pentazocine had statistically significant reduction in pain intensity at 2, 12, and 24 hours postoperatively compared to pentazocine alone (p <0.05). No significant side effects were noted in both groups. The combined group also had significantly better patient satisfaction scores. CONCLUSION: The addition of diclofenac suppository to intramuscular pentazocine provides better pain relief after cesarean section and increased patient satisfaction.

Evaluation Of Different Treatment Methods Against Denture Stomatitis: A Randomized Clinical Study.

The aim of this clinical study was to determine the efficacy of Uncaria tomentosa (cat's claw) against denture stomatitis (DS). Fifty patients with DS were randomly assigned into 3 groups to receive 2% miconazole, placebo, or 2% U tomentosa gel. DS level was recorded immediately, after 1 week of treatment, and 1 week after treatment. The clinical effectiveness of each treatment was measured using Newton's criteria. Mycologic samples from palatal mucosa and prosthesis were obtained to determinate colony forming units per milliliter (CFU/mL) and fungal identification at each evaluation period. Candida species were identified with HiCrome Candida and API 20C AUX biochemical test. DS severity decreased in all groups (P < .05). A significant reduction in number of CFU/mL after 1 week (P < .05) was observed for all groups and remained after 14 days (P > .05). C albicans was the most prevalent microorganism before treatment, followed by C tropicalis, C glabrata, and C krusei, regardless of the group and time evaluated. U tomentosa gel had the same effect as 2% miconazole gel. U tomentosa gel is an effective topical adjuvant treatment for denture stomatitis.

Development And Characterization Of A Cationic Lipid Nanocarrier As Non-viral Vector For Gene Therapy.

The aim of the present work was to produce a cationic solid lipid nanoparticle (SLN) as non-viral vector for protein delivery. Cationic SLN were produced by double emulsion method, composed of softisan(®) 100, cetyltrimethylammonium bromide (CTAB), Tween(®) 80, Span(®) 80, glycerol and lipoid(®) S75 loading insulin as model protein. The formulation was characterized in terms of mean hydrodynamic diameter (z-ave), polydispersity index (PI), zeta potential (ZP), stability during storage time, stability after lyophilization, effect of toxicity and transfection ability in HeLa cells, in vitro release profile and morphology. SLN were stable for 30days and showed minimal changes in their physicochemical properties after lyophilization. The particles exhibited a relatively slow release, spherical morphology and were able to transfect HeLa cells, but toxicity remained an obstacle. Results suggest that SLN are nevertheless promising for delivery of proteins or nucleic acids for gene therapy.

Estudo da circulação retrobulbar e do campo visual após dose única oral de citrato de sildenafil (Viagra®)

Purpose: To analyze the effects of 100 mg of sildenafil citrate (Viagra®) on the retrobulbar circulation and visual field. Methods: A double masked, placebo controlled study was conducted in 10 males with a mean age of 27.7 + 5.68 years. The right eye of each volunteer underwent orbital color Doppler imaging and automated perimetry (Humphrey, program 30-2, Full-Threshold Strategy) at 3 occasions: baseline, 1 hour after placebo and 1 hour after 100 mg of sildenafil. The foveal threshold and the mean deviation (MD) were analyzed by automated perimetry on the three occasions. Color Doppler imaging allowed the measurement of the peak systolic velocity (PSV), end diastolic velocity (EDV) and Pourcelot index (PI) in the central retinal artery and ophthalmic artery. Results: The foveal threshold and the mean deviation did not show a significant change following the administration of sildenafil. The ophthalmic artery peak systolic velocity and end diastolic velocity significantly increased after the administration of sildenafil (p<0.001). The hemodynamic parameters in the central retinal artery and the ophthalmic artery PI did not significantly change. Conclusions: Sildefanil citrate increased the blood flow velocities in the ophthalmic artery in normal subjects, with no significant changes in the foveal threshold and mean deviation in the automated perimetry.

Efeitos imediatos de um Sustained Natural Apophyseal Glide na atividade muscular dos eretores espinhais, na dor e na amplitude de flexão, em indivíduos com dor lombar crónica não específica

Introdução: O Sustained Natural Apophyseal Glide tem sido sugerido como uma técnica com potenciais benefícios na redução da dor e no aumento da amplitude de flexão lombar em indivíduos com dor lombar. Contudo, não existe evidência sobre esta técnica na atividade muscular dos eretores espinhais. Objetivo: Avaliar os efeitos imediatos de um Sustained Natural Apophyseal Glide na atividade muscular dos eretores espinhais, na intensidade da dor e na amplitude real de flexão lombar, em indivíduos com dor lombar crónica não específica. Métodos: Estudo experimental com uma amostra de 20 estudantes universitários, com dor lombar crónica não específica e com dor à flexão da coluna lombar, que foram aleatoriamente distribuídos em dois grupos: experimental - Sustained Natural Apophyseal Glide e placebo – intervenção placebo. Foram avaliadas a atividade muscular dos eretores espinhais recorrendo à eletromiografia de superfície (bioPLUX research®), a intensidade da dor através da Escala Visual Analógica e a amplitude real de flexão lombar pelo método de duplo inclinómetro (Universal Inclinometer®), antes e após a intervenção, pela análise do movimento de flexão-extensão do tronco. O nível de significância foi de 0,05. Resultados: Foram encontradas diferenças significativas, em ambos os grupos, para a fase de relaxamento (Grupo experimental: p=0,013 e Grupo placebo: p=0,047), assim como para a fase de extensão, no grupo experimental (p=0,037), verificando-se uma diminuição da atividade muscular da baseline para a avaliação final. A Análise da Covariância revelou que, relativamente à intensidade da dor, verificaram-se diferenças significativas entre os dois grupos (p=0,002), sendo que o grupo experimental diminuiu mais 2cm na Escala Visual Analógica do que o grupo placebo. Pela análise da amplitude real de flexão lombar, embora o aumento não fosse significativamente diferente entre os grupos (p=0,086), o grupo experimental teve mais 1,7º de aumento do que o grupo placebo. Conclusão: Os resultados sugerem que, a curto prazo, o Sustained Natural Apophyseal Glide parece produzir um efeito significativo na diminuição da atividade muscular dos eretores espinhais, durante o movimento dinâmico de extensão do tronco, assim como no alívio da dor. Embora não se tenham observado alterações significativas no aumento da amplitude articular, os resultados no grupo experimental foram superiores à diferença mínima detetável, sugerindo um efeito positivo da técnica aplicada.

Interrelation between parasitic infections and hypovitaminosis A: Schistosoma mansoni infection and the retinol blood levels in an endemic area of State of Minas Gerais (Brazil)

The interrelation between schistosomiasis and the retinol blood levels was studied in a double blind method, by comparing the serum vitamin A of the infected and non-infected group of an endemic area of Schistosoma mansoni infection. The infected group was characterized by 106 parasitized persons in the intestinal and hepatointestinal forms, who eliminated less than 500 eggs/gram of feces (Modified Kato's method); the non-infected group was characterized by 112 inhabitants of this endemic area without eggs in the stools and presenting negative intradermal reactions, and absence of previous specific treatment. The blood levels of retinol was determinated using trifluoracetic acid method, regarding the normal levels > 20,0mg/100ml. The results of this study point out the absence of correlation between S. mansoni infection and blood levels of vitamin A.

Using data mining techniques to support breast cancer diagnosis

More than ever, there is an increase of the number of decision support methods and computer aided diagnostic systems applied to various areas of medicine. In breast cancer research, many works have been done in order to reduce false-positives when used as a double reading method. In this study, we aimed to present a set of data mining techniques that were applied to approach a decision support system in the area of breast cancer diagnosis. This method is geared to assist clinical practice in identifying mammographic findings such as microcalcifications, masses and even normal tissues, in order to avoid misdiagnosis. In this work a reliable database was used, with 410 images from about 115 patients, containing previous reviews performed by radiologists as microcalcifications, masses and also normal tissue findings. Throughout this work, two feature extraction techniques were used: the gray level co-occurrence matrix and the gray level run length matrix. For classification purposes, we considered various scenarios according to different distinct patterns of injuries and several classifiers in order to distinguish the best performance in each case described. The many classifiers used were Naïve Bayes, Support Vector Machines, k-nearest Neighbors and Decision Trees (J48 and Random Forests). The results in distinguishing mammographic findings revealed great percentages of PPV and very good accuracy values. Furthermore, it also presented other related results of classification of breast density and BI-RADS® scale. The best predictive method found for all tested groups was the Random Forest classifier, and the best performance has been achieved through the distinction of microcalcifications. The conclusions based on the several tested scenarios represent a new perspective in breast cancer diagnosis using data mining techniques.

Hemispheric dorsolateral prefrontal cortex lateralization in the regulation of empathy for pain

The dorsolateral prefrontal cortex (DLPFC) is involved in the cognitive appraisal and modulation of the pain experience. In this sham-controlled study, with healthy volunteers, we used bi-hemispheric transcranial direct current stimulation (tDCS) over the DLPFC to assess emotional reactions elicited by pain observation. Left-cathodal/right-anodal tDCS decreased valence and arousal evaluations compared to other tDCS conditions. Compared to sham condition, both left-cathodal/right-anodal and left-anodal/right-cathodal tDCS decreased hostility, sadness and self-pain perception. These decreased sensations after both active tDCS suggest a common role for left and right DLPFC in personal distress modulation. However, the differences in arousal and valence evaluations point to distinct roles of lateralized DLPFC in cognitive empathy, probably through distinct emotion regulation mechanisms.

Estudo de estirpes probióticas como inoculantes de silagens para o controlo de micotoxinas

Dissertação de mestrado em Bioengenharia