916 resultados para major clinical study


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Background: Neuropsychiatric symptoms (NPS) affect almost all patients with dementia and are a major focus of study and treatment. Accurate assessment of NPS through valid, sensitive and reliable measures is crucial. Although current NPS measures have many strengths, they also have some limitations (e.g. acquisition of data is limited to informants or caregivers as respondents, limited depth of items specific to moderate dementia). Therefore, we developed a revised version of the NPI, known as the NPI-C. The NPI-C includes expanded domains and items, and a clinician-rating methodology. This study evaluated the reliability and convergent validity of the NPI-C at ten international sites (seven languages). Methods: Face validity for 78 new items was obtained through a Delphi panel. A total of 128 dyads (caregivers/patients) from three severity categories of dementia (mild = 58, moderate = 49, severe = 21) were interviewed separately by two trained raters using two rating methods: the original NPI interview and a clinician-rated method. Rater 1 also administered four additional, established measures: the Apathy Evaluation Scale, the Brief Psychiatric Rating Scale, the Cohen-Mansfield Agitation Index, and the Cornell Scale for Depression in Dementia. Intraclass correlations were used to determine inter-rater reliability. Pearson correlations between the four relevant NPI-C domains and their corresponding outside measures were used for convergent validity. Results: Inter-rater reliability was strong for most items. Convergent validity was moderate (apathy and agitation) to strong (hallucinations and delusions; agitation and aberrant vocalization; and depression) for clinician ratings in NPI-C domains. Conclusion: Overall, the NPI-C shows promise as a versatile tool which can accurately measure NPS and which uses a uniform scale system to facilitate data comparisons across studies. Copyright © 2010 International Psychogeriatric Association.

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Model: Prevalence study. Objectives: To evaluate the presence of self-reported hypertension to compare with blood pressure measurements. Besides, this work investigated health information level of workers and if the job position has any influence on blood pressure (BP). Methods: This study evaluated 349 health workers (44±10 years old) from Bauru and Jau cities, who answered some questions about history of health condition, use of medicines, past surgeries as well as social, scholar and physical conditions and had their blood pressure measured. Each subject selfreported as normotensive or hypertensive. Values of systolic ≥ 140 mmHg and/or diastolic PA ≥ 90 mmHg were considered elevated. Among the health workers evaluated, 198 were submitted to anthropometric and biochemical evaluations. Values are presented as means ± SD and frequency of distribution. It was used T-student test (p<0.05). Results: From all workers evaluated only 16% self-reported as hypertensive, which 56% presented high BP, however 91% used to take antihypertensive medicines. Among the 84% who self-reported as normotensive, 24% presented high BP and 8% used to take medicines. Although most of the employees of each section self-reported as normotensive, more than a half presented high BP and which was more common in the health's section (76.3%). Conclusion: These results suggest that besides the majority of the employees self-reported as normotensive, an elevated number of health workers presented high blood pressure and used to take medicines inappropriately, which indicates that they did not have enough knowledge about their health. Furthermore, it was observed that Health Section presented the higher blood pressure values.

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Background & Aims Patients infected with hepatitis C virus (HCV) genotype 1, body weight <85 kg, and high baseline viral load respond poorly to standard doses of pegylated interferon (peginterferon) and ribavirin. We evaluated intensified therapy with peginterferon alfa-2a plus ribavirin. Methods This double-blind randomized trial included HCV genotype 1-infected outpatients from hepatology clinics with body weight <85 kg and HCV RNA titer <400,000 IU/mL. Patients were randomized to 180 μg/wk peginterferon alfa-2a for 48 weeks plus 1200 mg/day ribavirin (standard of care) (group A, n = 191) or 1400/1600 mg/day ribavirin (group B, n = 189). Additional groups included 360 μg/wk peginterferon alfa-2a for 12 weeks then 180 μg/wk peginterferon alfa-2a for 36 weeks plus 1200 mg/day ribavirin (group C, n = 382) or 1400/1600 mg/day ribavirin (group D, n = 383). Follow-up lasted 24 weeks after treatment. Results Sustained virologic response rates (HCV RNA level <15 IU/mL at end of follow-up) in groups A, B, C, and D were 38%, 43%, 44%, and 41%, respectively. There were no significant differences among the 4 groups or between pooled peginterferon alfa-2a regimens (A + B vs C + D: odds ratio [OR], 1.08; 95% confidence interval [CI], 0.831.39; P = .584) or pooled ribavirin regimens (A + C vs B + D: OR, 1.00; 95% CI, 0.791.28; P = .974). Conclusions In patients infected with HCV genotype 1 who are difficult to treat (high viral load, body weight <85 kg), a 12-week induction regimen of peginterferon alfa-2a and/or higher-dose ribavirin is not more effective than the standard regimen. © 2010 AGA Institute.

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Open surgical repair of complex abdominal aortic aneurysms requires more extensive dissection and aortic clamping above the renal or mesenteric arteries. Although results of open surgical series have shown variation, morbidity and mortality is higher compared with infrarenal aortic aneurysm repair. Potential complications include renal insufficiency, mesenteric ischemia, multisystem organ failure, and death. Although endovascular treatment with fenestrated and branched endografts might potentially decrease the risk of complications and mortality, its role is not yet defined and the technology is not widely available. Issues related to durability of the procedure and secondary interventions might limit its application to patients with higher risk or those with hostile anatomy. This article summarizes the clinical results of open surgical repair of pararenal abdominal aortic aneurysms to provide a benchmark for comparison with results of endovascular treatment, using fenestrated and branched techniques. © Annals of Vascular Surgery Inc.

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Background: Atherosclerotic coronary artery disease (CAD) is a multifactorial process that appears to be caused by the interaction of environmental risk factors with multiple predisposing genes. It is nowadays accepted that increased levels of DNA damage induced by xenobiotics play an important role in the early phases of atherogenesis. Therefore, in this study, we focus on determining whether genetic variations in xenobiotic-metabolizing [glutathione-S-transferase theta 1 (GSTT1), glutathione-S-transferase mu 1 (GSTM1), cytochrome P450 IIEI (CYP2E1)] and DNA repair [X-ray cross-complementing group 1 (XRCC1)] genes might be associated with increased risk for CAD. Methods: A case-control study was conducted with 400 individuals who underwent subjected to coronary angiography. A total of 299 were patients diagnosed with effective coronary atherosclerosis (case group; >20% obstructive lesion), and 101 (control group) were individuals diagnosed as negative for CAD (<20% obstructive lesions). The polymorphism identifications for GSTM1 and GSTT1, and for CYP2E1 and XRCC1 genes were performed by polymerase chain reaction (PCR) amplification and by PCR-RFLP, respectively. Results and conclusions: The XRCC1 homozygous wild-type genotype Arg/Arg for codon 399 was statistically less pronounced in the case subjects (21.4%) than in controls (38.5%); individuals with the variant XRCC1 genotype had a 2.3-fold increased risk for coronary atherosclerosis than individuals with the wild-type genotype (OR=2.3, 95% CI=1.13-4.69). Conversely, no association between GSTM1, GSTT1, and CYP2E1gene polymorphisms and coronary atherosclerosis was detected. The results provide evidence of the role of DNA damage and repair in cardiovascular disease. © 2011 Elsevier Inc. All rights reserved.

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Objective: evaluating the adequacy, prescription and energy supply of enteral nutrition therapy in hospitalized patients. Methods: was performed a retrospective survey of the evolution of TNE protocol of 59 patients hospitalized in a general hospital in Marília / SP / BR. Data collected included gender, age, clinical diagnosis, anthropometric and dietary data related to the prescribed dietary formula, route and method of administration of the enteral nutrition, the daily volume prescribed and administered, the daily amount of energy required and offered in the diet, as well as possible complications. Body mass index (BMI), triceps skinfold (TSF) and arm muscle circumference (AMC) were used to establish the nutritional status of the patients. The adequacy of ENT was done according to the daily energy requirement compared to the average energy received during the daily use of ENT. Results: The average found to the BMI was 21.4 kg/m 2, and no differences were found comparing male and female. The data for TSF and AMC were different between genders (p<0.05) and suggest a more severe muscle mass in relation to adipose tissue. The averaged to the energy requirements was 1642 kcal/day but the average of energy prescribed was 1045 kcal/day and the amount offered was 1035 kcal/day. There was a significant difference between the necessity and the supplied energy offered through enteral nutrition (p=0.00) as well between the energy required and prescribed (p =0.00), both were shorter than the necessity. There was no significant difference (p>0.05) in energy supply, volume of enteral nutrition prescribed and administered among eutrophic, underweight or overweight patients. Conclusion: The results of this study indicate that the prescription and energy supply were not based on the needs of these patients, causing a significant energy deficit, which can lead to worsening of the nutritional status of the same. In hospitalized patients in use of ENT, the energy requirement must be made by a qualified professional within the multidisciplinary team, based on the needs of each patient.

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Objective: This prospective randomized trial evaluated if there is an improvement in clinical outcomes when assisted hatching is performed in embryos derived from vitrified oocytes in an ovum donation program. Methods: Sixty oocyte recipients undergoing donation program using egg-cryobanking were randomly allocated to the assisted hatched (AH, n=30) or control group (n=30). Pregnancy and implantation rates were compared between the groups. Vitrification and warming procedure were carried out according to the Cryotopmethod. Immediately before embryo transfer, embryos undergoing laser-assisted hatching had the zona pellucida thinned using a 1.48 μm wavelength diode laser. Results: A total of 288 vitrified MII oocytes were warmed for the 60 recipients (4.8 oocytes per recipient). Out of 288 vitrified oocytes, 273 (94.8%) survived. All surviving oocytes were sperm injected and 228 displayed 2 pronucleus 16-18h after injection (83.5%). There were 172 good quality embryos transferred. Twenty four patients achieved clinical pregnancy (total pregnancy rate of 40%). The clinical pregnancy rate did not differ between AH and control groups (44.4% and 33.3%, respectively, p=0.1967), however AH resulted in a significant higher implantation rate (31.6% and 18.4%, p=0.0206). These findings were confirmed by the regression models either for pregnancy (OR = 1.14; IC 95% = 0.80-.72; p= 0.766), as for the implantation rate (RC:19.45, P=0.041). Conclusions: Our evidences demonstrated the effectiveness of the AH in embryos derived from warmed oocytes and suggest that oocyte cryopreservation is a valuable tool to provide successful outcomes in an egg donor program. © Todos os direitos reservados a SBRA - Sociedade Brasileira de Reprodução Assistida.

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Objective: To evaluate if identified loci associated with normal age of menopause variation and early menopause can account for the poor response to controlled ovarian stimulation. Methods: A total of 71 patients, with age ≤ 35 years old, undergoing intracytoplasmic sperm injection were tested for three of the four newly identified genetic variants associated with normal variation in menopausal age and early menopause. Patients were divided into two groups: poor responder group (PR group, n=21) and normoresponder group (NR group, n=50). The influence of risk allele frequency on the response to controlled ovarian stimulation (COS) was evaluated. Logistic regression models were used. Results: There was no significant difference in the incidence of the genetic variants between NR and PR group. The risk allele for chromosome 19 variant (rs4806660) demonstrated a protective effect. The presence of a risk allele, either in homozygosis or in heterozygosis, was associated with an increased response to COS, resulting in an elevated number of follicles (Coef: 2.54, P= 0.041) and retrieved oocytes (Coef: 1.41, P= 0.041). Conclusions: Genetic variants rs244715, rs9379896 and rs4806660 are not risk factors for poor ovarian response. Instead, rs4806660 is associated with higher number of follicles and retrieved oocytes. It could be hypothesized that rs4806660 is associated with an increased response to gonadotrophin stimulus. © Todos os direitos reservados a SBRA - Sociedade Brasileira de Reprodução Assistida.

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There have been few studies on the mutations that cause heterozygous beta-thalassemia and how they affect the iron profile. One hundred and thirty-eight individuals were analyzed, 90 thalasemic β0 and 48 thalasemic β+, identified by classical and molecular methods. Mutations in the hemochromatosis (HFE) gene, detected using PCR-RFLP, were found in 30.4% of these beta-thalassemic patients; heterozygosity for H63D (20.3%) was the most frequent. Ferritin levels and transferrin saturation were similar in beta-thalassemics with and without mutations in the HFE gene. Ferritin concentrations were significantly higher in men and in individuals over 40 years of age. Transferrin saturation also was significantly higher in men, but only in those without HFE gene mutations. There was no significant difference in the iron profile among the β0 and β+ thalassemics, with and without HFE gene mutations. The frequency of ferritin values above 200 ng/mL in women and 300 ng/mL in men was also similar in β0 and β+ thalassemics (P > 0.72). Our conclusion is that ferritin levels are variable in the beta-thalassemia, trait regardless of the type of beta-globin mutation. Furthermore, HFE gene polymorphisms do not change the iron profile in these individuals. ©FUNPEC-RP www.funpecrp.com.br.

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Objective: This study aimed to characterize candidates undergo vasectomy in the public health system, Araçatuba- SP and to study related variables. Methods: We surveyed 300 medical patients and vasectomized contacted by telephone to assess several characteristics. The variables analyzed for the study were age, marital status, education, religion, monthly family income and per capita, number of living children, reason for seeking treatment method, contraceptive use, marital relationship quality, decision time (date of intent to perform the procedure) and not because of the procedure. Data were pooled for the analysis of results. Results: The age of the candidates ranged from 23 to 65 years (mean 36.86 years) and average 2.56 living sons. The average monthly family income was R$ 1.079,15, with average per capita income of R$ 249,07. The couple's contraception before the procedure was on account of the woman who used oral anti-conception (84%). The complication rate with the method was around 6.04%, the biggest complication was dehiscence (77.7% of cases of complications), these being mainly during the first 100 cases. Conclusion: Vasectomy is a very effective contraceptive method, with low complication rate and low cost, should be encouraged by the public health system as a means of family planning policy.

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Background: Cross-sectional studies have associated poor insight in patients with obsessive-compulsive disorder (OCD) with increased OCD symptom severity, earlier age of onset, comorbid depression, and treatment response. The goal of this current study was to examine the relationship between dimensions of OCD symptomatology and insight in a large clinical cohort of Brazilian patients with OCD. We hypothesized that poor insight would be associated with total symptom severity as well as with hoarding symptoms severity, specifically. Methods: 824 outpatients underwent a detailed clinical assessment for OCD, including the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the Dimensional Yale-Brown Obsessive-Compulsive Scale (DY-BOCS), the Brown Assessment of Beliefs Scale (BABS), a socio-demographic questionnaire, and the Structured Clinical Interview for axis I DSM-IV disorders (SCID-P). Tobit regression models were used to examine the association between level of insight and clinical variables of interest. Results: Increased severity of current and worst-ever hoarding symptoms and higher rate of unemployment were associated with poor insight in OCD after controlling for current OCD severity, age and gender. Poor insight was also correlated with increased severity of current OCD symptoms. Conclusion: Hoarding and overall OCD severity were significantly but weakly associated with level of insight in OCD patients. Further studies should examine insight as a moderator and mediator of treatment response in OCD in both behavioral therapy and pharmacological trials. Behavioral techniques aimed at enhancing insight may be potentially beneficial in OCD, especially among patients with hoarding. © 2011.

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Objectives: To evaluate the association between the consumption of different dietary fats with the quality of the diet, insulin resistance, and hyperhomocysteinemia in adults. Methods: Cross-sectional study conducted with 624 overweight subjects (73.7% females). Assessments of food intake (24h food recall and health eating index-HEI), anthropometry, and biochemical assays of fasting glucose, insulin (HOMA-IR and β calculus) and homocysteinemia were performed. Results: The low quality of diet was associated with the vegetable oil at 3rd quintile (≥1.5-2.0 servings) showed risk 2.9 times and cholesterol at quintiles 2nd, 3rd, and 4th was 2.0 times. HOMA-IR was higher at 5th quintile of saturated fat (≥10,7% - total caloric value) with risk of 60% and hyperhomocysteinemia the vegetable oil at 3rd quintile (>1.5-2.0 servings) with risk of 12.0 times and 5th (≥3.5 servings) 7.1 times. However, significance disappeared when adjusted for anthropometric variables. Conclusion: Dietary fats were associated with the harm diet quality, insulin resistance, and hyperhomocysteinemia. However, associations are dependant of demographic variables, dietetic, and nutritional state. © 2011 CELOM.

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A cross observational study was achieved about hypertensive patients from the Basic Health Unit in Betel, Paulinia - S.P. assessing blood pressure levels, anthropometric data, biosocial variables, responses to questionaires about physical activity (Ipaq), and quality of life (Whoqol), as well as estimates of cardiovascular risk by Framingham score. With descriptive purposes, absolute and relative frequencies distributions are presented. From originally 95 people in the study, 18 were eliminated, and the remaining 77 were predominately composed by women, averaged 55.87 years old (standard deviation 11.88); white ethnic; basic schooling education, and income of 3 minimum salaries. Although clinical criteria verified altered values, it was the physical evaluation that indicated more clearly risks of contracting cardiovascular diseases, thus showing how different complementary evaluations can better predict risk. These results demonstrated that other professionals should be an asset as an integral part of the health team. © Copyright Moreira Jr. Editora. Todos os direitos reservados.

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Background: The chemokine receptor 1 CXCR-1 (or IL8R-alpha) is a specific receptor for the interleukin 8 (IL-8), which is chemoattractant for neutrophils and has an important role in the inflammatory response. The polymorphism rs2234671 at position Ex2+860G > C of the CXCR1 gene causes a conservative amino acid substitution (S276T). This single nucleotide polymorphism (SNP) seemed to be functional as it was associated with decreased lung cancer risk. Previous studies of our group found association of haplotypes in the IL8 and in the CXCR2 genes with the multifactorial disease chronic periodontitis. In this study we investigated the polymorphism rs2234671 in 395 Brazilian subjects with and without chronic periodontitis. Findings. Similar distribution of the allelic and genotypic frequencies were observed between the groups (p > 0.05). Conclusions: The polymorphism rs2234671 in the CXCR1 gene was not associated with the susceptibility to chronic periodontitis in the studied Brazilian population. © 2011 Scarel-Caminaga et al; licensee BioMed Central Ltd.