bluuebunny/crossref_metadata_2025_split huggingface dataset:
Diabetes abrogates sex differences and aggravates cardiometabolic risk in postmenopausal women
Authors: Mascarenhas-Melo Filipa , Marado Daniela , Palavra Filipe , Sereno José , Coelho Álvaro , Pinto Rui , Teixeira-Lemos Edite , Teixeira Frederico , Reis Flávio 
Published: April 2013

Abstract

Background
The aim of this study is to evaluate the effect of gender and menopause in cardiometabolic risk in a type 2 diabetes mellitus (T2DM) population, based on classical and non-traditional markers.

Methods
Seventy four volunteers and 110 T2DM patients were enrolled in the study. Anthropometric data, blood pressure, body mass index (BMI), waist circumference (WC) and the following serum markers were analyzed: glucose, Total-c, TGs, LDL-c, Oxidized-LDL, total HDL-c and large and small HDL-c subpopulations, paraoxonase 1 activity, hsCRP, uric acid, TNF-α, adiponectin and VEGF.

Results
Non-diabetic women, compared to men, presented lower glycemia, WC, small HDL-c, uric acid, TNF-α and increased large HDL-c. Diabetes abrogates the protective effect of female gender, since diabetic women showed increased BMI, WC, small HDL-c, VEGF, uric acid, TNF-α and hsCRP, as well as reduced adiponectin, when compared with non-diabetic. In diabetic females, but not in males, WC is directly and significantly associated with TNF-α, VEGF, hsCRP and uric acid; TNF-α is directly associated with VEGF and hsCRP, and inversely with adiponectin. Postmenopausal females presented a worsen cardiometabolic profile, viewed by the increased WC, small HDL-c, VEGF, uric acid, TNF-α and hsCRP. In this population, WC is directly and significantly associated with TNF-α, VEGF, hsCRP; TNF-α is directly associated with VEGF; and uric acid is inversely associated with large HDL-c and hsCRP with adiponectin, also inversely.

Conclusions
Diabetes abrogates the protective effect of gender on non-diabetic women, and postmenopausal diabetic females presented worsen cardiometabolic risk, including a more atherogenic lipid sketch and a pro-inflammatory and pro-angiogenic profile. The classical cardiovascular risk factors (CVRFs) fail to completely explain these differences, which are better clarified using “non-traditional” factors, such as HDL-c subpopulations, rather than total HDL-c content, and markers of inflammation and angiogenesis, namely TNF-α, hsCRP, uric acid and VEGF. Multi-therapeutic intervention, directed to obesity, atherogenic lipid particles and inflammatory mediators is advisory in order to efficiently prevent the serious diabetic cardiovascular complications.
Effects of imiglucerase on the growth and metabolism of Gaucher disease type I patients: a systematic review
Authors: Doneda Divair , Netto Cristina B , Moulin Cileide C , Schwartz Ida Vanessa D 
Published: April 2013

Abstract

Background
Gaucher disease (GD) type I is the most common type of GD. Its main clinical manifestations are hepatosplenomegaly as well as bone and hematological abnormalities. The objective of the present study was to perform a literature review on the growth and metabolism of GD type I patients.

Methods
We searched Pubmed and Scielo.br databases with predetermined study limits: case series (n≥5), clinical trials, systematic reviews, and meta-analyses, and enzyme replacement therapy (ERT) with alglucerase or imiglucerase. The outcomes of interest were the following: growth and development, weight, height, malnutrition, overweight, obesity, basal metabolism, hypermetabolism, insulin resistance, and diabetes. A total of 175 articles were found, of which 28 met the inclusion criteria; these articles were grouped into three central themes: 1) growth of children and adolescents before and after ERT; 2) metabolic changes that remained during ERT; and 3) changes in metabolic status resulting from the treatment.

Results and discussion
The articles included in the present literature review are very heterogeneous, which hinders the analysis of data. They indicated that GD patients usually show low weight and height before ERT, which are improved with treatment in children and adolescents. Studies evaluating the energy metabolism by indirect calorimetry have indicated that the disease is associated with hypermetabolism. In adults, some changes in energy metabolism remain on ERT, and alterations, such as insulin resistance, seem to be associated with the treatment. It is not clear which are the required doses of imiglucerase for obtaining an adequate cost-effective relation, as well as the advisable therapeutic measures to avoid possible long-term adverse effects related to ERT.

Conclusions
ERT tends to normalise the growth of children and adolescents with GD type I, it seems to cause a partial response in relation to some metabolic changes associated with the disease, and it can causes metabolic changes such as weight gain in adult patients. Therefore, additional research is necessary.
The Greek version of the MacArthur competence assessment tool for treatment: reliability and validity. Evaluation of capacity for treatment decisions in Greek psychiatric patients
Authors: Bilanakis Nikolaos , Vratsista Aikaterini , Kalampokis Georgios , Papamichael Georgios , Peritogiannis Vaios 
Published: April 2013

AbstractBackgroundPatients’ informed consent prior to treatment initiation is an essential component of contemporary clinical practice, but sometimes, patients lack decision-making capacity for treatment. Such capacity can be reliably assessed with standardized tools used, and the MacArthur competence assessment tool for treatment (MacCAT-T) is one of the most widely used instruments.MethodsThe objective of this study was to translate the MacCAT-T into Greek and evaluate the Greek version’s reliability and validity in psychiatric patients. Thirty-nine psychiatric inpatients were examined with the MacCAT-T, and results showed an excellent inter-rater reliability.ResultsIntraclass correlations ranged from 0.93 to 1 for the individual items of the tool. Severity of psychopathology was negatively correlated with reasoning, appreciation, and expressing a choice (Pearson’sr0.36, 0.539, and 0.338, respectively), but there were no associations with demographic characteristics of the patients. Of the five factors derived from the brief psychiatric rating scale, anergia was significantly correlated with appreciation, reasoning, and expressing a choice (Pearson’sr0.46, 0.45, and 0.37, respectively).ConclusionsThe Greek version of the MacCAT-T is a reliable and valid instrument that can provide a standardized measure for assessing treatment decision capacity in Greek psychiatric patients and can be used for evaluation in the clinical practice.
Stereotactic body radiotherapy with a focal boost to the MRI-visible tumor as monotherapy for low- and intermediate-risk prostate cancer: early results
Authors: Aluwini Shafak , van Rooij Peter , Hoogeman Mischa , Kirkels Wim , Kolkman-Deurloo Inger-Karine , Bangma Chris 
Published: April 2013

Abstract

Background
There is growing evidence that prostate cancer (PC) cells are more sensitive to high fraction dose in hypofractionation schemes. High-dose-rate (HDR) brachytherapy as monotherapy is established to be a good treatment option for PC using extremely hypofractionated schemes. This hypofractionation can also be achieved with stereotactic body radiotherapy (SBRT). We report results on toxicity, PSA response, and quality of life (QOL) in patients treated with SBRT for favorable-risk PC.

Methods
Over the last 4 years, 50 hormone-naïve patients with low- and intermediate-risk PC were treated with SBRT to a total dose of 38 Gy delivered in four daily fractions of 9.5 Gy. An integrated boost to 11 Gy per fraction was applied to the dominant lesion if visible on MRI. Toxicity and QoL was assessed prospectively using validated questionnaires.

Results
Median follow-up was 23 months. The 2-year actuarial biochemical control rate was 100%. Median PSA nadir was 0.6 ng/ml. Median International Prostate Symptoms Score (IPSS) was 9/35 before treatment, with a median increase of 4 at 3 months and remaining stable at 13/35 thereafter. The EORTC/RTOG toxicity scales showed grade 2 and 3 gastrointestinal (GI) acute toxicity in 12% and 2%, respectively. The late grade 2 GI toxicity was 3% during 24 months FU. Genitourinary (GU) grade 2, 3 toxicity was seen in 15%, 8%, in the acute phase and 10%, 6% at 24 months, respectively. The urinary, bowel and sexual domains of the EORTC-PR25 scales recovered over time, showing no significant changes at 24 months post-treatment.

Conclusions
SBRT to 38 Gy in 4 daily fractions for low- and intermediate-risk PC patients is feasible with low acute and late genitourinary and gastrointestinal toxicity. Longer follow-up preferably within randomized studies, is required to compare these results with standard fractionation schemes.
Observational study of the effects of age, diabetes mellitus, cirrhosis and chronic kidney disease on sublingual microvascular flow
Authors: Reynolds Toby , Vivian-Smith Amanda , Jhanji Shaman , Pearse Rupert M 
Published: April 2013

Abstract

Background
Sidestream dark field (SDF) imaging has been used to demonstrate microcirculatory abnormalities in a variety of critical illnesses. The microcirculation is also affected by advancing age and chronic comorbidities. However, the effect of these conditions on SDF microcirculatory parameters has not been well described.

Methods
SDF images were obtained from five groups of 20 participants: healthy volunteers under the age of 25, healthy volunteers over the age of 55, and clinic patients over the age of 55 with one of diabetes mellitus, cirrhosis and stage 5 chronic kidney disease. Microcirculatory parameters between the groups were then compared for significance using analysis of variance for parametric and the Kruskal-Wallis test for non-parametric data.

Results
Median microvascular flow index was 2.85 (interquartile range 2.75 to 3.0) for participants aged <25, 2.81 (2.66 to 2.97) for those aged >55, 2.88 (2.75 to 3.0) for those with diabetes mellitus, 3.0 (2.83 to 3.0) for those with cirrhosis and 3.0 (2.78 to 3.0) for those with chronic kidney disease (P for difference between groups = 0.14). Similarly, there were no significant differences in the proportion of perfused vessels and perfused vessel density between the groups.

Conclusions
Older age, diabetes, and chronic kidney and liver disease need not be considered confounding factors for comparison of SDF microcirculatory parameters in the critically ill.
Phase III, Randomized, Placebo-Controlled Study of Docetaxel in Combination With Zibotentan in Patients With Metastatic Castration-Resistant Prostate Cancer
Authors: Fizazi Karim , Higano Celestia S. , Nelson Joel B. , Gleave Martin , Miller Kurt , Morris Thomas , Nathan Faith E. , McIntosh Stuart , Pemberton Kristine , Moul Judd W. 
Published: April 2013

Purpose As part of the ENTHUSE (Endothelin A Use) program, the efficacy and safety of zibotentan (ZD4054), an oral specific endothelin A receptor antagonist, has been investigated in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (CRPC). Patients and Methods In this randomized, double-blind, placebo-controlled, phase III study, patients received intravenous docetaxel 75 mg/m2 on day 1 of 21-day cycles plus oral zibotentan 10 mg or placebo once daily. The primary end point was overall survival (OS). Secondary end points included time to pain and prostate-specific antigen (PSA) progression, pain and PSA response, progression-free survival, health-related quality of life, and safety. Results A total of 1,052 patients received study treatment (docetaxel-zibotentan, n = 524; docetaxel-placebo, n = 528). At the time of data cutoff, there had been 277 and 280 deaths, respectively. There was no difference in OS for patients receiving docetaxel-zibotentan compared with those receiving docetaxel-placebo (hazard ratio, 1.00; 95% CI, 0.84 to 1.18; P = .963). No significant differences were observed on secondary end points, including time to pain progression (median 9.3 v 10.0 months, respectively) or pain response (odds ratio, 0.84; 95% CI, 0.61 to 1.16; P = .283). The median time to death was 20.0 and 19.2 months for the zibotentan and placebo groups, respectively. The most commonly reported adverse events in zibotentan-treated patients were peripheral edema (52.7%), diarrhea (35.4%), alopecia (33.9%), and nausea (33.3%). Conclusion Docetaxel plus zibotentan 10 mg/d did not result in a significant improvement in OS compared with docetaxel plus placebo in patients with metastatic CRPC.
Phase II Trial of the CDK4 Inhibitor PD0332991 in Patients With AdvancedCDK4-Amplified Well-Differentiated or Dedifferentiated Liposarcoma
Authors: Dickson Mark A. , Tap William D. , Keohan Mary Louise , D'Angelo Sandra P. , Gounder Mrinal M. , Antonescu Cristina R. , Landa Jonathan , Qin Li-Xuan , Rathbone Dustin D. , Condy Mercedes M. , Ustoyev Yelena , Crago Aimee M. , Singer Samuel , Schwartz Gary K. 
Published: April 2013

PurposeCDK4 is amplified in > 90% of well-differentiated (WDLS) and dedifferentiated liposarcomas (DDLS). The selective cyclin-dependent kinase 4 (CDK4)/CDK6 inhibitor PD0332991 inhibits growth and induces senescence in cell lines and xenografts. In a phase I trial of PD0332991, several patients with WDLS or DDLS experienced prolonged stable disease. We performed an open-label phase II study to determine the safety and efficacy of PD0332991 in patients with advanced WDLS/DDLS.Patients and MethodsPatients age ≥ 18 years experiencing disease progression while receiving systemic therapy before enrollment received PD0332991 200 mg orally once per day for 14 consecutive days in 21-day cycles. All were required to have CDK4 amplification by fluorescence in situ hybridization and retinoblastoma protein (RB) expression by immunohistochemistry (≥ 1+). The primary end point was progression-free survival (PFS) at 12 weeks, with 12-week PFS of ≥ 40% considered promising and ≤ 20% not promising. If ≥ nine of 28 patients were progression free at 12 weeks, PD0332991 would be considered active.ResultsWe screened 48 patients (44 of 48 had CDK4 amplification; 41 of 44 were RB positive). Of those, 30 were enrolled, and 29 were evaluable for the primary end point. Grade 3 to 4 events included anemia (17%), thrombocytopenia (30%), neutropenia (50%), and febrile neutropenia (3%). At 12 weeks, PFS was 66% (90% CI, 51% to 100%), significantly exceeding the primary end point. The median PFS was 18 weeks. There was one partial response.ConclusionTreatment with the CDK4 inhibitor PD0332991 was associated with a favorable progression-free rate in patients with CDK4-amplified and RB-expressing WDLS/DDLS who had progressive disease despite systemic therapy.
Intensive Chemotherapy and Immunotherapy in Patients With Newly Diagnosed Primary CNS Lymphoma: CALGB 50202 (Alliance 50202)
Authors: Rubenstein James L. , Hsi Eric D. , Johnson Jeffrey L. , Jung Sin-Ho , Nakashima Megan O. , Grant Barbara , Cheson Bruce D. , Kaplan Lawrence D. 
Published: April 2013

Purpose Concerns regarding neurocognitive toxicity of whole-brain radiotherapy (WBRT) have motivated development of alternative, dose-intensive chemotherapeutic strategies as consolidation in primary CNS lymphoma (PCNSL). We performed a multicenter study of high-dose consolidation, without WBRT, in PCNSL. Objectives were to determine: one, rate of complete response (CR) after remission induction therapy with methotrexate, temozolomide, and rituximab (MT-R); two, feasibility of a two-step approach using high-dose consolidation with etoposide plus cytarabine (EA); three, progression-free survival (PFS); and four, correlation between clinical and molecular prognostic factors and outcome. Patients and Methods Forty-four patients with newly diagnosed PCNSL were treated with induction MT-R, and patients who achieved CR received EA consolidation. We performed a prospective analysis of molecular prognostic biomarkers in PCNSL in the setting of a clinical trial. Results The rate of CR to MT-R was 66%. The overall 2-year PFS was 0.57, with median follow-up of 4.9 years. The 2-year time to progression was 0.59, and for patients who completed consolidation, it was 0.77. Patients age > 60 years did as well as younger patients, and the most significant clinical prognostic variable was treatment delay. High BCL6 expression correlated with shorter survival. Conclusion CALGB 50202 demonstrates for the first time to our knowledge that dose-intensive consolidation for PCNSL is feasible in the multicenter setting and yields rates of PFS and OS at least comparable to those of regimens involving WBRT. On the basis of these encouraging results, an intergroup study has been activated comparing EA consolidation with myeloablative chemotherapy in this randomized trial in PCNSL, in which neither arm involves WBRT.
Tracheostomy for Infants Requiring Prolonged Mechanical Ventilation: 10 Years’ Experience
Authors: Overman Alison E. , Liu Meixia , Kurachek Stephen C. , Shreve Michael R. , Maynard Roy C. , Mammel Mark C. , Moore Brooke M. 
Published: April 2013

BACKGROUND:Despite advances in care of critically ill neonates, extended mechanical ventilation and tracheostomy are sometimes required. Few studies focus on complications and clinical outcomes. Our aim was to provide long-term outcomes for a cohort of infants who required tracheostomy.METHODS:This study is a retrospective review of 165 infants born between January 1, 2000 and December 31, 2010 who required tracheostomy and ventilator support. Children with complex congenital heart disease were excluded.RESULTS:Median gestational age was 27 weeks (range 22–43), and birth weight was 820 g (range 360–4860). The number of male (53.9%) and female (46.1%) infants was similar (P = .312). Infants were divided into 2 groups based on birth weight ≤1000 g (A) and &gt;1000 g (B). Group A: 87 (57.6%) infants; group B 64 (42.4%). Overall tracheostomy rate was 6.9% (87/1345) for group A versus 0.9% (64/6818) for B (P &lt;.001). Group A had a longer time from intubation to positive pressure ventilation independence, 505 days (range 62–1287) vs 372 days (range 15–1270; P = .011). Infants who had &gt;1 reason for tracheostomy comprised 78.8% of the sample; 69.1% of infants were discharged on ventilators. Birth weight did not affect time from tracheostomy to decannulation (P = .323). More group A infants were decannulated (P = .023). laryngotracheal reconstruction rate was 35.8%. Five-year survival was 89%. Group B had higher mortality (P = .033). 64.2% of infants had developmental delays; 74.2% had ≥2 comorbidities.CONCLUSIONS:Tracheostomy rates were higher for extremely low birth weight infants than previously reported rates for all infants. Decannulation rates and laryngotracheal reconstruction rates were consistent with previous studies. Survival rates were high, but developmental delay and comorbidities were frequent.
Kidney Function and Tobacco Smoke Exposure in US Adolescents
Authors: García-Esquinas Esther , Loeffler Lauren F. , Weaver Virginia M. , Fadrowski Jeffrey J. , Navas-Acien Ana 
Published: April 2013

BACKGROUND AND OBJECTIVE:Active smoking and secondhand smoke (SHS) are known risk factors for kidney disease in adults. We evaluated the association between exposure to active smoking or SHS and kidney function in US adolescents.METHODS:This is a cross-sectional study in 7516 adolescents aged 12–17 who participated in NHANES 1999–2010 and had serum creatinine and cotinine measures. Active smoking was defined as self-reported smoking or serum cotinine concentrations &gt;10 ng/mL. SHS was defined as nonactive smokers who self-reported living with ≥1 smokers or serum cotinine concentrations ≥ 0.05 ng/mL. Kidney function was determined by using the chronic kidney disease in children estimated glomerular filtration rate (eGFR) equation.RESULTS:Median (interquartile range) eGFR and serum cotinine concentrations were 96.8 (85.4–109.0) mL/minute per 1.73 m2 and 0.07 (0.03–0.59) ng/mL, respectively. After multivariable adjustment, eGFR decreased 1.1 mL/minute per 1.73 m2 (95% confidence interval [CI]: −1.8 to −0.3) per interquartile range increase in serum cotinine concentrations. The mean (95%CI) difference in eGFR for serum cotinine tertiles 1, 2, and 3 among children exposed to SHS compared to unexposed were −0.4 (−1.9 to 1.2), −0.9 (−2.7 to 0.9), and −2.2 (−4.0 to −0.4) mL/minute per 1.73 m2, respectively (P = .03). The corresponding values among tertiles of active smokers compared to unexposed were 0.2 (−2.2 to 2.6), −1.9 (−3.8 to 0.0), and −2.6 (−4.6 to −0.6) mL/minute per 1.73 m2 (P = .01).CONCLUSIONS:Tobacco smoke exposure was associated with decreased eGFR in US adolescents, supporting the possibility that tobacco smoke effects on kidney function begin in childhood.
Two-Year Clinical Performance of a Low-Shrinkage Composite in Posterior Restorations
Authors: Baracco B , Perdigão J , Cabrera E , Ceballos L 
Published: April 2013

SUMMARY

Objectives
The aim of this study was to compare the two-year clinical performance of three restorative systems in posterior restorations, which included a low-shrinkage composite and both etch-and-rinse and self-etch adhesive strategies.

Materials and Methods
After signing an informed consent, 25 patients received three Class I (occlusal) or Class II restorations performed with one of three restorative systems: Filtek Silorane Restorative System, Adper Scotchbond 1 XT (a two-step etch-and-rinse adhesive) with Filtek Z250, and Adper Scotchbond SE (a two-step self-etch adhesive) with Filtek Z250. All materials were applied following the manufacturer's instructions. Two blind observers evaluated the restorations at three different moments (baseline; and after one and two years) according to the US Public Health Service modified criteria. Kruskal-Wallis test and Mann-Whitney U-test were used to compare the behavior of the restorative systems, while Friedman and Wilcoxon tests were applied to analyze the intra-system data (p&lt;0.05).

Results
The three restorative systems showed a statistically similar clinical performance at two years. Intra-system comparisons between baseline and two years showed declining marginal adaptation scores in the restorations placed with all systems. In addition, marginal staining and surface roughness scores were lower after two years for the restorations placed with Adper Scotchbond SE + Filtek Z250.

Conclusions
Although the clinical performance of Filtek Silorane was considered acceptable after two years, no advantage of the silorane-based resin over the methacrylate-based composite was found. Teeth restored with Adper Scotchbond SE showed a tendency for marginal staining, which may compromise the final color of the restorations.