Metabolic Improvements in Obese Type 2 Diabetes Subjects Implanted for 1 Year with an Endoscopically Deployed Duodenal-Jejunal Bypass Liner

Background: The purpose of this study was to evaluate the effect of the duodenal-jejunal bypass liner (DJBL), a 60-cm, impermeable fluoropolymer liner anchored in the duodenum to create a duodenal-jejunal bypass, on metabolic parameters in obese subjects with type 2 diabetes. Methods: Twenty-two subjects (mean age, 46.2 +/- 10.5 years) with type 2 diabetes and a body mass index between 40 and 60 kg/m(2) (mean body mass index, 44.8 +/- 7.4 kg/m(2)) were enrolled in this 52-week, prospective, open-label clinical trial. Endoscopic device implantation was performed with the patient under general anesthesia, and the subjects were examined periodically during the next 52 weeks. Primary end points included changes in fasting blood glucose and insulin levels and changes in hemoglobin A1c (HbA1c). The DJBL was removed endoscopically at the end of the study. Results: Thirteen subjects completed the 52-week study, and the mean duration of the implant period for all subjects was 41.9 +/- 3.2 weeks. Reasons for early removal of the device included device migration (n = 3), gastrointestinal bleeding (n = 1), abdominal pain (n = 2), principal investigator request (n = 2), and discovery of an unrelated malignancy (n = 1). Using last observation carried forward, statistically significant reductions in fasting blood glucose (-30.3 +/- 10.2 mg/dL), fasting insulin (-7.3 +/- 2.6 mu U/mL), and HbA1c (-2.1 +/- 0.3%) were observed. At the end of the study, 16 of the 22 subjects had an HbA1c < 7% compared with only one of 22 at baseline. Upper abdominal pain (n = 11), back pain (n = 5), nausea (n = 7), and vomiting (n = 7) were the most common device-related adverse events. Conclusions: The DJBL improves glycemic status in obese subjects with diabetes and therefore represents a nonsurgical, reversible alternative to bariatric surgery.

Effect of Complete Revascularization on 10-Year Survival of Patients With Stable Multivessel Coronary Artery Disease MASS II Trial

Background-The importance of complete revascularization remains unclear and contradictory. This current investigation compares the effect of complete revascularization on 10-year survival of patients with stable multivessel coronary artery disease (CAD) who were randomly assigned to percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). Methods and Results-This is a post hoc analysis of the Second Medicine, Angioplasty, or Surgery Study (MASS II), which is a randomized trial comparing treatments in patients with stable multivessel CAD, and preserved systolic ventricular function. We analyzed patients who underwent surgery (CABG) or stent angioplasty (PCI). The survival free of overall mortality of patients who underwent complete (CR) or incomplete revascularization (IR) was compared. Of the 408 patients randomly assigned to mechanical revascularization, 390 patients (95.6%) underwent the assigned treatment; complete revascularization was achieved in 224 patients (57.4%), 63.8% of those in the CABG group and 36.2% in the PCI group (P = 0.001). The IR group had more prior myocardial infarction than the CR group (56.2% X 39.2%, P = 0.01). During a 10-year follow-up, the survival free of cardiovascular mortality was significantly different among patients in the 2 groups (CR, 90.6% versus IR, 84.4%; P = 0.04). This was mainly driven by an increased cardiovascular specific mortality in individuals with incomplete revascularization submitted to PCI (P = 0.05). Conclusions-Our study suggests that in 10-year follow-up, CR compared with IR was associated with reduced cardiovascular mortality, especially due to a higher increase in cardiovascular-specific mortality in individuals submitted to PCI.

A 15-year study on the treatment of undernourished children at a nutrition rehabilitation centre (CREN), Brazil

Objective: To build a life table and determine the factors related to the time of treatment of undernourished children at a nutrition rehabilitation centre (CREN), Sao Paulo, Brazil. Design: Nutritional status was assessed from weight-for-age, height-for-age and BMI-for-age Z-scores, while neuropsychomotor development was classified according to the milestones of childhood development. Life tables, Kaplan-Meier survival curves and Cox multiple regression models were employed in data analysis. Setting: CREN (Centre of Nutritional Recovery and Education), Sao Paulo, Brazil. Subjects: Undernourished children (n 228) from the southern slums of Sao Paulo who had received treatment at CREN under a day-hospital regime between the years 1994 and 2009. Results: The Kaplan-Meier curves of survival analysis showed statistically significant differences in the periods of treatment at CREN between children presenting different degrees of neuropsychomotor development (log-rank = 6.621; P = 0.037). Estimates based on the multivariate Cox model revealed that children aged >= 24 months at the time of admission exhibited a lower probability of nutritional rehabilitation (hazard ratio (HR) = 0.49; P = 0.046) at the end of the period compared with infants aged up 12 months. Children presenting slow development were better rehabilitated in comparison with those exhibiting adequate evolution (HR = 4.48; P = 0.023). No significant effects of sex, degree of undernutrition or birth weight on the probability of nutritional rehabilitation were found. Conclusions: Age and neuropsychomotor developmental status at the time of admission to CREN are critical factors in determining the duration of treatment.

Prevention of recurrent herpes labialis outbreaks through low-intensity laser therapy: a clinical protocol with 3-year follow-up

Conselho Nacional de Pesquisa e Desnsenvolvimento Tecnologico (CNPq)

Influence of Roux-en-Y Gastric Bypass Surgery on Vitamin C, Myeloperoxidase, and Oral Clinical Manifestations: A 2-Year Follow-Up Study

Background: Bariatric surgery influences the intake and absorption of nutrients. The serum concentrations of vitamin C, myeloperoxidase (MPO) and oral clinical manifestations were examined in patients two years after Roux-en-Y gastric bypass (RYGB). Methods: Clinical prospective-study with control-group (CG; n = 26), assessed only once, and the bariatric-group (BG; n = 26), assessed in the basal period and at 12 and 24 months after surgery. The mean ages in the CG and BG were 37.8 +/- 1.51 and 39.6 +/- 1.93 years, respectively, and their body mass indices were 22.07 +/- 0.29 and 45.62 +/- 1.46 kg/m2, respectively. Results: At 12 months after surgery, increased episodes of vomiting (P < .001) and dental hypersensitivity (P=.012) were observed, with a reduction in the saliva buffering capacity of 21.3 2.9% (P=.004). At 24 months after RYGB, we detected a significant reduction in serum vitamin C (32.9 +/- 5.3%, P < .001) and MPO values were higher than in the basal period (P = .032). With regard to oral hygiene habits, 92.3% of patients reported frequent tooth brushing and 96.1% used fluoride, which were similar across the two years. However, dental hypersensitivity (P = .048) was significantly increased than baseline. Conclusions: The results demonstrated that vitamin C deficiency and increased vomiting after RYGB for morbid obesity may contribute to increased periodontal disease. The fact it is impossible to determine which factors (diet, poor compliance with supplementation, vomiting, poor oral hygiene) contributed to the dental problems in these patients is a shortcoming of the report. (Nutr Clin Pract. 2012; 27: 114-121)

Late clinical outcomes after implantation of drug-eluting stents coated with biodegradable polymers: 3-year follow-up of the PAINT randomised trial

Aims: The long-term clinical performance of drug-eluting stents (DES) coated with biodegradable polymers is poorly known. Methods and results: A total of 274 coronary patients were randomly allocated to paclitaxel-eluting stents, sirolimus-eluting stents, or bare metal stems (2:2:1 ratio). The two DES used the same biodegradable polymers and were identical except for the drug. At three years, the pooled DES population had similar rates of cardiac death or myocardial infarction (9.0% vs. 7.1; p=0.6), but lower risk of repeat interventions (10.0% vs. 29.9%; p<0.01) than controls with bare stents. The cumulative 3-year incidence of definite or probable stent thrombosis in the pooled DES group was 2.3% (first year: 1.8%; second year: 0.4%; third year: zero). There were no significant differences in outcomes between paclitaxel- and sirolimus-eluting stents. Conclusions: The biodegradable-polymer coated DES releasing either paclitaxel or sirolimus were effective in reducing the 3-year rate of re-interventions.

RNA extraction from ten year old formalin-fixed paraffin-embedded breast cancer samples: a comparison of column purification and magnetic bead-based technologies

Abstract Background The development of protocols for RNA extraction from paraffin-embedded samples facilitates gene expression studies on archival samples with known clinical outcome. Older samples are particularly valuable because they are associated with longer clinical follow up. RNA extracted from formalin-fixed paraffin-embedded (FFPE) tissue is problematic due to chemical modifications and continued degradation over time. We compared quantity and quality of RNA extracted by four different protocols from 14 ten year old and 14 recently archived (three to ten months old) FFPE breast cancer tissues. Using three spin column purification-based protocols and one magnetic bead-based protocol, total RNA was extracted in triplicate, generating 336 RNA extraction experiments. RNA fragment size was assayed by reverse transcription-polymerase chain reaction (RT-PCR) for the housekeeping gene glucose-6-phosphate dehydrogenase (G6PD), testing primer sets designed to target RNA fragment sizes of 67 bp, 151 bp, and 242 bp. Results Biologically useful RNA (minimum RNA integrity number, RIN, 1.4) was extracted in at least one of three attempts of each protocol in 86–100% of older and 100% of recently archived ("months old") samples. Short RNA fragments up to 151 bp were assayable by RT-PCR for G6PD in all ten year old and months old tissues tested, but none of the ten year old and only 43% of months old samples showed amplification if the targeted fragment was 242 bp. Conclusion All protocols extracted RNA from ten year old FFPE samples with a minimum RIN of 1.4. Gene expression of G6PD could be measured in all samples, old and recent, using RT-PCR primers designed for RNA fragments up to 151 bp. RNA quality from ten year old FFPE samples was similar to that extracted from months old samples, but quantity and success rate were generally higher for the months old group. We preferred the magnetic bead-based protocol because of its speed and higher quantity of extracted RNA, although it produced similar quality RNA to other protocols. If a chosen protocol fails to extract biologically useful RNA from a given sample in a first attempt, another attempt and then another protocol should be tried before excluding the case from molecular analysis.

Effect of 6-months of physical exercise on the nitrate/nitrite levels in hypertensive postmenopausal women

Abstract Background Evidences have showed that the incidence of arterial hypertension is greater in postmenopausal women as compared to premenopausal. Physical inactivity has been implicated as a major contributor to weight gain and abdominal obesity in postmenopausal women and the incidence of cardiovascular disease increases dramatically after menopause. Additionally, more women than men die each year of coronary heart disease and are twice as likely as men to die within the first year after a heart attack. A healthy lifestyle has been strongly associated with the regular physical activity and evidences have shown that physically active subjects have more longevity with reduction of morbidity and mortality. Nitric oxide (NO) produced by endothelial cells has been implicated in this beneficial effect with improvement of vascular relaxing and reduction in blood pressure in both laboratory animals and human. Although the effect of exercise training in the human cardiovascular system has been largely studied, the majority of these studies were predominantly conducted in men or young volunteers. Therefore, the aim of this work was to investigate the effects of 6 months of dynamic exercise training (ET) on blood pressure and plasma nitrate/nitrite concentration (NOx-) in hypertensive postmenopausal women. Methods Eleven volunteers were submitted to the ET consisting in 3 days a week, each session of 60 minutes during 6 months at moderate intensity (50% of heart rate reserve). Anthropometric parameters, blood pressure, NOx- concentration were measured at initial time and after ET. Results A significant reduction in both systolic and diastolic blood pressure values was seen after ET which was accompanied by markedly increase of NOx- levels (basal: 10 ± 0.9; ET: 16 ± 2 μM). Total cholesterol was significantly reduced (basal: 220 ± 38 and ET: 178 ± 22 mg/dl), whereas triglycerides levels were not modified after ET (basal: 141 ± 89 and ET: 147 ± 8 mg/dl). Conclusion Our study shows that changing in lifestyle promotes reduction of arterial pressure which was accompanied by increase in nitrite/nitrate concentration. Therefore, 6-months of exercise training are an important approach in management arterial hypertension and play a protective effect in postmenopausal women.

Questionnaire for monitoring auditory and language development in the first year of life

Purpose: To validate a monitoring questionnaire about hearing and language development applied by community health agents in the first year of life. Methods: Seventy six community health agents, previously trained on infant hearing health, administered a questionnaire to the families of 304 children with ages from 0 to 1 year. The questionnaire contains questions regarding hearing and language development and, for all age groups, the question “Does your child hear well?” was presented. The validity of the questionnaire was assessed by analyzing false positive and false negative rates of the identified children. A double-blind study was conducted so that all children assessed by the questionnaire were submitted to hearing evaluation performed by audiologists. Results: Four children (1.32%) were diagnosed with sensorineural hearing loss (two unilateral), and 69 (22.7%) with conductive hearing loss. The monitoring questionnaire showed specificity of 96% and sensitivity of 67%, with a false-negative rate of 33% for not identifying the unilateral hearing loss, and a false-positive rate of 4%. Conclusion: The questionnaire used has shown to be feasible and relevant to actions of the community health agents of the Family Health Strategy program, with high specificity and moderate sensitivity. The use of the validated instrument should be considered to complement Newborn Hearing Screening Programs, in order to identify late onset or acquired hearing loss.

Cross-cultural adaptation and psychometric properties of the Brazilian version of the scale of oral health outcomes for 5-year-old children (SOHO-5)

Abstract Background Most of the instruments available to measure the oral health-related quality of life (OHRQoL) in paediatric populations focus on older children, whereas parental reports are used for very young children. The scale of oral health outcomes for 5-year-old children (SOHO-5) assesses the OHRQoL of very young children through self-reports and parental proxy reports. We aimed to cross-culturally adapt the SOHO-5 to the Brazilian Portuguese language and to assess its reliability and validity. Findings We tested the quality of the cross-cultural adaptation in 2 pilot studies with 40 children aged 5–6 years and their parents. The measurement was tested for reliability and validity on 193 children that attended the paediatric dental screening program at the University of São Paulo. The children were also clinically examined for dental caries. The internal consistency was demonstrated by a Cronbach's alpha coefficient of 0.90 for the children’s self-reports and 0.77 for the parental proxy reports. The test-retest reliability results, which were based on repeated administrations on 159 children, were excellent; the intraclass correlation coefficient was 0.98 for parental and 0.92 for child reports. In general, the construct validity was satisfactory and demonstrated consistent and strong associations between the SOHO-5 and different subjective global ratings of oral health, perceived dental treatment need and overall well-being in both the parental and children’s versions (p < 0.001). The SOHO-5 was also able to clearly discriminate between children with and without a history of dental caries (mean scores: 5.8 and 1.1, respectively; p < 0.001). Conclusion The present study demonstrated that the SOHO-5 exhibits satisfactory psychometric properties and is applicable to 5- to 6-year-old children in Brazil.

Longitudinal brain volumetric changes during one year in non-elderly healthy adults: a voxel-based morphometry study

Previous cross-sectional magnetic resonance imaging (MRI) studies of healthy aging in young adults have indicated the presence of significant inverse correlations between age and gray matter volumes, although not homogeneously across all brain regions. However, such cross-sectional studies have important limitations and there is a scarcity of detailed longitudinal MRI studies with repeated measures obtained in the same individuals in order to investigate regional gray matter changes during short periods of time in non-elderly healthy adults. In the present study, 52 healthy young adults aged 18 to 50 years (27 males and 25 females) were followed with repeated MRI acquisitions over approximately 15 months. Gray matter volumes were compared between the two times using voxel-based morphometry, with the prediction that volume changes would be detectable in the frontal lobe, temporal neocortex and hippocampus. Voxel-wise analyses showed significant (P < 0.05, family-wise error corrected) relative volume reductions of gray matter in two small foci located in the right orbitofrontal cortex and left hippocampus. Separate comparisons for males and females showed bilateral gray matter relative reductions in the orbitofrontal cortex over time only in males. We conclude that, in non-elderly healthy adults, subtle gray matter volume alterations are detectable after short periods of time. This underscores the dynamic nature of gray matter changes in the brain during adult life, with regional volume reductions being detectable in brain regions that are relevant to cognitive and emotional processes.

Habilidades auditivas e medidas da imitância acústica em crianças de 4 a 6 anos de idade

OBJETIVO: avaliar o desempenho em habilidades auditivas e as condições de orelha média de crianças de 4 a 6 anos de idade. MÉTODO: foram aplicados os testes de detecção sonora (audiômetro pediátrico em 20dBNA), a Avaliação Simplificada do Processamento Auditivo (ASPA) e as medidas de imitância acústica (handtymp com tom de 226Hz) em 61 crianças com média de idade de 5,65 anos. Para comparar os resultados das provas de habilidades auditivas e das medidas da imitância acústica foi aplicado o teste exato de Fisher com nível de significância de p< 0,05. RESULTADOS: houve alteração em pelo menos uma das habilidades auditivas investigadas em 24,6% das crianças. Houve alteração timpanométrica em 34,4% das crianças e 64% foram classificadas no critério "falha" para a pesquisa do reflexo acústico ispilateral. As crianças mais jovens apresentaram maior ocorrência de alterações de orelha média, mas não houve diferença estatisticamente significante entre as diferentes idades para as provas realizadas. CONCLUSÃO: as crianças mais jovens apresentaram maior ocorrência de alterações nas provas de habilidades auditivas e nas medidas de imitância acústica. Programas de investigação e acompanhamento das condições de orelha média e das habilidades auditivas em idade pré-escolar e escolar podem eliminar ou minimizar intercorrências que alterariam o desenvolvimento sócio-linguístico.

Riabilitazione del mascellare posteriore atrofico mediante impianti corti (6-8 mm) o rialzo di seno con contestuale inserimento di impianti di lunghezza standard: studio retrospettivo con follow up a 3 anni

Background: sebbene la letteratura recente abbia suggerito che l’utilizzo degli impianti corti possa rappresentare una alternative preferibile alle procedure di rigenerazione ossea nelle aree posteriori atrofiche, perché è un trattamento più semplice e con meno complicazioni, esistono solo pochi studi a medio e lungo termine che abbiano comparato queste tecniche. Scopo: lo scopo di questo studio retrospettivo è quello di valutare se gli impianti corti (6-8 mm) (gruppo impianti corti) possano presentare percentuali di sopravvivenza e valori di riassorbimento osseo marginali simili a impianti di dimensioni standard (≥11 mm) inseriti contemporaneamente ad una grande rialzo di seno mascellare. Materiali e Metodi: in totale, 101 pazienti sono stati inclusi: 48 nel gruppo impianti corti e 53 nel gruppo seno. In ciascun paziente da 1 a 3 impianti sono stati inseriti e tenuti sommersi per 4-6 mesi. I parametri clinici e radiografici valutati sono: i fallimenti implantari, le complicazioni, lo stato dei tessuti molli, e il riassorbimento osseo marginale. Tutti i pazienti sono stati seguiti per almeno 3 anni dal posizionamento implantare. Risultati: il periodo di osservazione medio è stato di 43.47 ± 6.1 mesi per il gruppo impianti corti e 47.03 ± 7.46 mesi per il gruppo seno. Due su 101 impianti corti e 6 su 108 impianti standard sono falliti. Al follow-up finale, si è riscontrato un riassorbimento osseo medio di 0.47 ± 0.48 mm nel gruppo impianti corti versus 0.64 ± 0.58 mm nel gruppo seno. Non sono presenti differenze statisticamente significative fra i gruppi in termini di fallimenti implantari, complicazioni protesiche, tessuti molli, e riassorbimento osseo. Il gruppo seno ha presentato, invece, un maggior numero di complicazioni chirurgiche. Conclusioni: entrambe le tecniche hanno dimostrato un simile tasso di successo clinico e radiografico, ma gli impianti corti hanno ridotto il numero di complicazioni chirurgiche.