Biostatistical Center

Pittsburgh, PA, United States

Biostatistical Center

Pittsburgh, PA, United States
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Olivieri F.,Marche Polytechnic University | Spazzafumo L.,Biostatistical Center | Santini G.,Marche Polytechnic University | Lazzarini R.,Marche Polytechnic University | And 10 more authors.
Mechanisms of Ageing and Development | Year: 2012

Circulating microRNAs (miRs) have been investigated as diagnostic/prognostic biomarkers in human diseases. However, little is known about their expression throughout the aging process.Eleven healthy individuals aged 20, 80 and 100. years underwent miR plasma profiling. The validation cohort consisted of 111 healthy adults (CTR) aged 20-105. years and included 30 centenarians. In addition, 34 patients with cardiovascular disease (CVD) and 15 healthy centenarian offspring (CO) were enrolled.An exploratory factorial analysis grouped the miRs into three main factors: factor 1 primarily higher in 20-year-old subjects, but these differences did not reach statistical significance, factor 2 primarily higher in octogenarians and factor 3 primarily higher in centenarians. MiR-21, the most highly expressed miR of factors 2 and 3, was further validated, confirming the differences in the age groups. MiR-21 expression was higher in the CVD patients and lower in the CO compared to the age-matched CTR. MiR-21 was correlated with C-reactive protein and fibrinogen levels. TGF-β signaling was the predicted common pathway targeted by miRs of factors 2 and 3. TGF-βR2 mRNA, a validated miR-21 target, showed the highest expression in the leukocytes from a subset of the octogenarians.Our findings suggest that miR-21 may be a new biomarker of inflammation. © 2012 Elsevier Ireland Ltd.

Tang G.,University of Pittsburgh | Tang G.,Biostatistical Center | Kong Y.,Biogen Idec | Chang C.-C.H.,University of Pittsburgh | And 2 more authors.
Pharmaceutical Statistics | Year: 2012

In a phase III multi-center cancer clinical trial or a large public health study, sample size is predetermined to achieve desired power, and study participants are enrolled from tens or hundreds of participating institutions. As the accrual is closing to the target size, the coordinating data center needs to project the accrual closure date on the basis of the observed accrual pattern and notify the participating sites several weeks in advance. In the past, projections were simply based on some crude assessment, and conservative measures were incorporated in order to achieve the target accrual size. This approach often resulted in excessive accrual size and subsequently unnecessary financial burden on the study sponsors. Here we proposed a discrete-time Poisson process-based method to estimate the accrual rate at time of projection and subsequently the trial closure date. To ensure that target size would be reached with high confidence, we also proposed a conservative method for the closure date projection. The proposed method was illustrated through the analysis of the accrual data of the National Surgical Adjuvant Breast and Bowel Project trial B-38. The results showed that application of the proposed method could help to save considerable amount of expenditure in patient management without compromising the accrual goal in multi-center clinical trials. Copyright © 2012 John Wiley & Sons, Ltd.

PubMed | Taichung Veterans General Hospital, Chang Gung Childrens Hospital Kaohsiung, Biostatistical Center, China Medical University at Taichung and 7 more.
Type: Clinical Trial | Journal: Pediatric blood & cancer | Year: 2016

Discontinuation of E. coli l-asparaginase in patients with acute lymphoblastic leukemia (ALL) is unavoidable upon severe allergic reaction. We sought to examine outcomes following E. coli l-asparaginase discontinuation due to severe allergic reactions.We evaluated the outcome of children enrolled in Taiwan Pediatric Oncology Group-2002-ALL protocol between 2002 and 2012, who had E. coli l-asparaginase discontinued due to severe allergic reactions, and compared the outcomes of those who continued with Erwinia l-asparaginase (Erwinase) with those who did not.Among 700 patients enrolled in this study, 33 patients had E. coli l-asparaginase treatment discontinued due to severe allergic reactions. Five-year overall survival did not differ significantly among the 648 patients without discontinuation (81 1.6%, mean SE), compared to 17 patients with allergic reactions and treated with Erwinase (88 7.8%) and 16 patients with allergic reactions but not treated with Erwinase (87 8.6%). Among 16 patients who did not receive Erwinase, all 10 who received 50% of the scheduled doses of E. coli l-asparaginase before discontinuation survived without events.Erwinase treatment may not be needed for some ALL patients with severe allergy to E. coli l-asparaginase if 50% of prescribed doses were received and/or therapy is augmented with other agents.

PubMed | Research Hospital of Casatenovo, Research Hospital of Cosenza, Italian National Research Center on Aging, Biostatistical Center and Advanced Technology Center for Aging Research
Type: Clinical Trial | Journal: Aging clinical and experimental research | Year: 2015

Italy is expected to experience the largest growth in persons 65 years (>20% by 2020). This demographic shift allows for geriatric research on predictive clinical and biological markers of outcomes related to frailty, re-hospitalization and mortality.To describe rationale and methods of the Report-AGE study project of acute care patients in Italian National Research Center on Aging (INRCA) research hospitals.Report-AGE study is a large observational study on health conditions and outcomes of hospitalized elderly patients (65 years). The primary objective of the study is to create a high-level data resource of demographics, comprehensive geriatric assessments, clinical and diagnostic information, as well as biological and molecular markers in all older patients admitted to INRCA Hospitals. Assessments in physical and nutritional parameters, co-morbid health conditions, and associations with frailty parameters are ongoing in older hospitalized adults following an acute event. Study collection began in September 2011.Up to date, there are 3479 patients 65 years (mean age: 85 7years) with 1543 men and 1936 women enrolled. Data have been recorded regarding functional and clinical parameters before, during hospital admission and at discharge. Data collection for primary outcome analyses related to re-hospitalization and mortality is estimated for September 2016.This study aims at collecting precise clinical data, comprehensive geriatric assessment, risk factors, and biological data from acute care patients. Data will also be used to identify mechanisms underlying frailty in this specific population.This study provides a descriptive epidemiological collection of the health conditions of older in-patients.

PubMed | Biostatistical Center, Innsbruck Medical University, CNR Institute for Organic Syntheses and Photoreactivity, Charité - Medical University of Berlin and 7 more.
Type: Journal Article | Journal: Clinical nutrition (Edinburgh, Scotland) | Year: 2016

Eating habits may influence the life span and the quality of ageing process by modulating inflammation. The RISTOMED project was developed to provide a personalized and balanced diet, enriched with or without nutraceutical compounds, to decrease and prevent inflammageing, oxidative stress and gut microbiota alteration in healthy elderly people. This paper focused on the effect on inflammation and metabolism markers after 56 days of RISTOMED dietalone or supplementation with three nutraceutical compounds.A cohort of 125 healthy elderly subjects was recruited and randomized into 4 arms (Arm A, RISTOMED diet; Arm B, RISTOMED diet plus VSL#3 probiotic blend; Arm C, RISTOMED diet plus AISA d-Limonene; Arm D, RISTOMED diet plus Argan oil). Inflammatory and metabolism parameters as well as the ratio between Clostridium cluster IV and Bifidobacteria (CL/B) were collected before and after 56 days of dietary intervention, and their evolution compared among the arms. Moreover, participants were subdivided according to their baseline inflammatory parameters (erythrocytes sedimentation rate (ESR), C-Reactive Protein, fibrinogen, Tumor Necrosis Factor-alfa (TNF-), and Interleukin 6) in two clusters with low or medium-high level of inflammation. The evolution of the measured parameters was then examined separately in each cluster.Overall, RISTOMED dietalone or with each nutraceutical supplementation significantly decreased ESR. RISTOMED diet supplemented with d-Limonene resulted in a decrease in fibrinogen, glucose, insulin levels and HOMA-IR. The most beneficial effects were observed in subjects with a medium-high inflammatory status who received RISTOMED diet with AISA d-Limonene supplementation. Moreover, RISTOMED diet associated with VSL#3 probiotic blend induced a decrease in the CL/B ratio.Overall, this study emphasizes the beneficial anti-inflammageing effect of RISTOMED diet supplemented with nutraceuticals to control the inflammatory status of elderly individuals.

PubMed | Biostatistical Center, Innsbruck Medical University, Charité - Medical University of Berlin, University of Bologna and 4 more.
Type: Journal Article | Journal: Clinical nutrition (Edinburgh, Scotland) | Year: 2015

To assess the impact of a personalized diet, with or without addition of VSL#3 preparation, on biomarkers of inflammation, nutrition, oxidative stress and intestinal microbiota in 62 healthy persons aged 65-85 years.Open label, randomized, multicenter study.High-sensitivity C-reactive protein.Community.Eight week web-based dietary advice (RISTOMED platform) alone or with supplementation of VSL#3 (2 capsules per day). The RISTOMED diet was optimized to reduce inflammation and oxidative stress.Blood and stool samples were collected on days 1 and 56.Diet alone reduced ESR (p = 0.02), plasma levels of cholesterol (p < 0.01) and glucose (p = 0.03). Addition of VSL#3 reduced ESR (p = 0.05) and improved folate (p = 0.007), vitamin B12 (p = 0.001) and homocysteine (p < 0.001) plasma levels. Neither intervention demonstrated any further effects on inflammation. Subgroup analysis showed 40 participants without signs of low-grade inflammation (hsCRP<3 mg/l, subgroup 1) and 21 participants with low-grade inflammation at baseline (hsCRP3 mg/l, subgroup 2). In subgroup 2 addition of VSL#3 increased bifidobacteria (p = 0.005) in more participants and improved both folate (p = 0.015) and vitamin B12 (p = 0.035) levels compared with subgroup 1. The increases were positively correlated to the change in the bifidobacteria concentration for folate (p = 0.023) and vitamin B12 (p = 0.001). As expected change in homocysteine correlated negatively to change in folate (r = -0.629, p = 0.002) and vitamin B12 (r = -0.482, p = 0.026).Addition of VSL#3 increased bifidobacteria and supported adequate folate and vitamin B12 concentrations in subjects with low-grade inflammation. Decrease in homocysteine with VSL#3 was clinically relevant. suggesting protective potentials for aging-associated conditions, e.g. cardiovascular or neurological diseases. NCT01069445-NCT01179789.

Lucertini F.,Urbino University | Spazzafumo L.,Biostatistical Center | de Lillo F.,Urbino University | Centonze D.,Urbino University | And 2 more authors.
European Journal of Sport Science | Year: 2013

Physical education (PE) at school is an important starting point for long-term interventions improving quality of life in elderly. To evaluate the effectiveness of professionally led PE on motor and health-related abilities of Italian primary schoolchildren (3rd-5th graders), three schools were assigned to the experimental groups "A" (38 pupils, 17 M, 21 F) and "B" (37 pupils, 16 M, 21 F), and to control group "C" (26 pupils, 18 M, 8 F). All groups underwent a six-month, twice-a-week (60 min each session) PE intervention. The PE program of the EGs was age-tailored, included strength training and was administered by specialised teachers. Group A and B programs differed in the strength training devices used, while they were identical in terms of training load. The control group program was not structured and administered by generalist teachers. At baseline and follow-up, children underwent a motor and health-related abilities test battery. At follow-up, children in group C gained significantly more weight than children in the EGs and scored significantly less than the children in the EGs in the following assessments: counter movement jump (C:+0.15% vs. A:+4.1% and B:+6.99%), plate tapping (C:+13.56% vs. A:+19.37% and B:+36.12%), sit-and-reach (C:-311.15% vs. B:+409.57%), pinch strength (C:+2.39% vs. B:+10.83, on average) and sit-up (C:+29.69% vs. A:+72.61%). In conclusion, specialist-led pupils demonstrated greater increases in some motor and health-related abilities tests compared to generalist-led peers, while different strength training devices produced comparable increases of strength in both EGs. © 2013 Copyright European College of Sport Science.

Van de Perre V.,Catholic University of Leuven | Permentier L.,Catholic University of Leuven | De Bie S.,VLAM vzw | Verbeke G.,Biostatistical Center | Geers R.,Catholic University of Leuven
Meat Science | Year: 2010

A total of 12,725 pigs originating from 90 transports were followed up at 17 Belgian commercial slaughterhouses. The effects of several pre-slaughter parameters concerning transport, unloading, lairage, pig handling, stunning and season on fresh meat quality based on pH measurements 30. minutes (min) after slaughter were investigated. Meat quality was measured on 4285 pigs. Ten pre-slaughter parameters had a significant effect on meat pH after separate introduction of the variable as a fixed effect in the model. Simultaneous analysis of these variables in the global model revealed that the pH was influenced by four main risk factors, namely the mean noise level produced during unloading, the percentage of panting pigs, the use of an electric prod and season. Meat quality in terms of the percentage of potentially PSE carcasses was better in summer than spring or autumn and could be explained by a lower observed pre-stunning stress in summer. © 2010 The American Meat Science Association.

PubMed | Neurology Unit, Biostatistical Center and Asur AV2
Type: Journal Article | Journal: American journal of Alzheimer's disease and other dementias | Year: 2015

The objective of our study was to demonstrate that living with a person affected by mild to moderate Alzheimers disease can lead to an increased perception of the caregivers burden using the Caregiver Burden Inventory (CBI). The sample consisted of 153 dyads, caregiver-patient. At baseline, a greater perception of the caregivers burden was observed in the live-in caregivers. A further increase in the total burden of the live-in caregivers was noticed at the 6-month follow-up. More specifically, with the inclusion of correction factors such as the caregivers age and the CBI subscales at baseline, the social and emotional burden becomes statistically significant (P < .001). The present paper confirms our hypothesis that live-in caregivers perceive a greater burden than nonlive-in, and this difference increases further after 6 months. The difference in involvement between live-in and nonlive-in caregivers could be the foundation to tailor more specific interventions.

PubMed | Italian National Research Center on Aging and Biostatistical Center
Type: Journal Article | Journal: Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology | Year: 2016

Subjective cognitive and memory complaints (SMC) are common in later life and are considered an indicator for progression to cognitive decline. The aim of the present study was to identify the relationship among SMC, neuropsychiatric symptoms and psychological aspects in elderly subjects with mild cognitive impairment (MCI) as well as to analyse the effect on SMC of a comprehensive cognitive training. Data from a sample of 94 patients enrolled in My Mind Project (Grant No. 154/GR-2009-1584108) were collected. The study evidenced that depression was a significant predictor of SMC and that after the training, the number of subjects with SMC was significantly reduced in the experimental group in comparison to the control one. These results suggest that the participation in cognitive stimulation protocols may improve the perception of SMC in subjects with MCI.

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