Science.gov

Sample records for baseline characteristics glycaemia

  1. The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study

    PubMed Central

    Bonds, Denise E; Gerstein, Hertzel C; Seaquist, Elizabeth R; Bergenstal, Richard M; Calles-Escandon, Jorge; Childress, R Dale; Craven, Timothy E; Cuddihy, Robert M; Dailey, George; Feinglos, Mark N; Ismail-Beigi, Farmarz; Largay, Joe F; O’Connor, Patrick J; Paul, Terri; Savage, Peter J; Schubart, Ulrich K; Sood, Ajay; Genuth, Saul

    2010-01-01

    Objectives To investigate potential determinants of severe hypoglycaemia, including baseline characteristics, in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial and the association of severe hypoglycaemia with levels of glycated haemoglobin (haemoglobin A1C) achieved during therapy. Design Post hoc epidemiological analysis of a double 2×2 factorial, randomised, controlled trial. Setting Diabetes clinics, research clinics, and primary care clinics. Participants 10 209 of the 10 251 participants enrolled in the ACCORD study with type 2 diabetes, a haemoglobin A1C concentration of 7.5% or more during screening, and aged 40-79 years with established cardiovascular disease or 55-79 years with evidence of significant atherosclerosis, albuminuria, left ventricular hypertrophy, or two or more additional risk factors for cardiovascular disease (dyslipidaemia, hypertension, current smoker, or obese). Interventions Intensive (haemoglobin A1C <6.0%) or standard (haemoglobin A1C 7.0-7.9%) glucose control. Main outcome measures Severe hypoglycaemia was defined as episodes of “low blood glucose” requiring the assistance of another person and documentation of either a plasma glucose less than 2.8 mmol/l (<50 mg/dl) or symptoms that promptly resolved with oral carbohydrate, intravenous glucose, or glucagon. Results The annual incidence of hypoglycaemia was 3.14% in the intensive treatment group and 1.03% in the standard glycaemia group. We found significantly increased risks for hypoglycaemia among women (P=0.0300), African-Americans (P<0.0001 compared with non-Hispanic whites), those with less than a high school education (P<0.0500 compared with college graduates), aged participants (P<0.0001 per 1 year increase), and those who used insulin at trial entry (P<0.0001). For every 1% unit decline in the haemoglobin A1C concentration from baseline to 4 month visit, there was a 28% (95% CI 19% to 37%) and 14% (4% to 23%) reduced risk of hypoglycaemia

  2. Balancing multiple baseline characteristics in randomized clinical trials.

    PubMed

    Su, Zheng

    2011-07-01

    It is of vital importance to the success of a randomized clinical trial to maintain the balance of baseline characteristics (covariates) that could potentially confound the outcomes of the trial. Various randomization methods have been proposed to increase the likelihood of having balanced covariates at the end of a trial, most of which only apply to categorical covariates. An optimization approach to maintaining the balance of multiple covariates in randomized clinical trials is proposed, which is applicable to both continuous and categorical covariates and allows the covariates to be ranked according to their clinical importance as perceived by the clinical trial practitioners. Simulation results show that the proposed algorithm significantly outperforms the standard randomization approach via flipping an unbiased coin. The proposed randomization method can be easily implemented and generalized for cases where there are multiple treatment arms with equal or unequal randomization probabilities. Copyright © 2011 Elsevier Inc. All rights reserved.

  3. Design and baseline characteristics of the LANDMARK study.

    PubMed

    Ogata, Hiroaki; Fukagawa, Masafumi; Hirakata, Hideki; Kaneda, Hideaki; Kagimura, Tatsuo; Akizawa, Tadao

    2017-06-01

    Calcium (Ca)-based phosphate (P) binders, compared to non-Ca-based P binders, contribute to vascular calcification, which is associated with cardiovascular events. The LANDMARK study is a multicenter, randomized, open-label, parallel comparative study of lanthanum carbonate (LC) and calcium carbonate (CC) in hemodialysis patients. Stable hemodialysis patients with intact parathyroid hormone ≤240 pg/mL meeting ≥1 of the following criteria (age >65 years, postmenopause, diabetes mellitus) were randomized into the LC and CC groups. LC group patients initially received LC 750 mg/day or the previously used dose and were titrated up to a maximum 2250 mg/day to achieve serum P levels of 3.5-6.0 mg/dL. CC group patients received CC 3 g/day or the previously used dose and were titrated to achieve the same P range. If the target serum P level was not achieved, non-Ca-based P binders (other than LC) could also be added. The primary endpoint is survival time free of cardiovascular events, including cardiovascular death, non-fatal myocardial infarction or stroke, and unstable angina. Overall, 2309 patients were allocated to the LC (N = 1154) or CC group (N = 1155). At baseline, the mean age was 68.4 years, 40.4 % were women, 55.9 % had diabetes, 18.3 % had a history of ischemic heart disease, and 13.9 % had cerebrovascular disease. A total of 184 patients (8.4 %) had undergone coronary intervention procedures. Baseline characteristics were well balanced between groups. The LANDMARK study will determine whether LC, a non-Ca-based P binder, reduces cardiovascular mortality and morbidity in chronic hemodialysis patients.

  4. Baseline Characteristics of Patients Predicting Suitability for Rapid Naltrexone Induction

    PubMed Central

    Mogali, Shanthi; Khan, Nabil A.; Drill, Esther S.; Pavlicova, Martina; Sullivan, Maria A.; Nunes, Edward; Bisaga, Adam

    2015-01-01

    Background and Objectives Extended-release (XR) injection naltrexone has proved promising in the treatment of opioid dependence. Induction onto naltrexone is often accomplished with a procedure known as rapid naltrexone induction. The purpose of this study was to evaluate pre-treatment patient characteristics as predictors of successful completion of a rapid naltrexone induction procedure prior to XR naltrexone treatment. Methods A chart review of 150 consecutive research participants (N = 84 completers and N = 66 non-completers) undergoing a rapid naltrexone induction with the buprenorphone-clonidine procedure were compared on a number of baseline demographic, clinical and psychosocial factors. Logistic regression was used to identify client characteristics that may predict successful initiation of naltrexone after a rapid induction-detoxification. Results Patients who failed to successfully initiate naltrexone were younger (AOR: 1.040, CI: 1.006, 1.075), and using 10 or more bags of heroin (or equivalent) per day (AOR: 0.881, CI: 0.820, 0.946). Drug use other than opioids was also predictive of failure to initiate naltrexone in simple bivariate analyses, but was no longer significant when controlling for age and opioid use level. Conclusions Younger age, and indicators of greater substance dependence severity (more current opioid use, other substance use) predict difficulty completing a rapid naltrexone induction procedure. Such patients might require a longer period of stabilization and/or more gradual detoxification prior to initiating naltrexone. Scientific Significance Our study findings identify specific characteristics of patients who responded positively to rapid naltrexone induction. PMID:25907815

  5. ALMA Long Baseline Campaigns: Phase Characteristics of Atmosphere at Long Baselines in the Millimeter and Submillimeter Wavelengths

    NASA Astrophysics Data System (ADS)

    Matsushita, Satoki; Asaki, Yoshiharu; Fomalont, Edward B.; Morita, Koh-Ichiro; Barkats, Denis; Hills, Richard E.; Kawabe, Ryohei; Maud, Luke T.; Nikolic, Bojan; Tilanus, Remo P. J.; Vlahakis, Catherine; Whyborn, Nicholas D.

    2017-03-01

    We present millimeter- and submillimeter-wave phase characteristics measured between 2012 and 2014 of Atacama Large Millimeter/submillimeter Array long baseline campaigns. This paper presents the first detailed investigation of the characteristics of phase fluctuation and phase correction methods obtained with baseline lengths up to ∼15 km. The basic phase fluctuation characteristics can be expressed with the spatial structure function (SSF). Most of the SSFs show that the phase fluctuation increases as a function of baseline length, with a power-law slope of ∼0.6. In many cases, we find that the slope becomes shallower (average of ∼0.2–0.3) at baseline lengths longer than ∼1 km, namely showing a turn-over in SSF. These power law slopes do not change with the amount of precipitable water vapor (PWV), but the fitted constants have a weak correlation with PWV, so that the phase fluctuation at a baseline length of 10 km also increases as a function of PWV. The phase correction method using water vapor radiometers (WVRs) works well, especially for the cases where PWV > 1 {mm}, which reduces the degree of phase fluctuations by a factor of two in many cases. However, phase fluctuations still remain after the WVR phase correction, suggesting the existence of other turbulent constituent that cause the phase fluctuation. This is supported by occasional SSFs that do not exhibit any turn-over; these are only seen when the PWV is low (i.e., when the WVR phase correction works less effectively) or after WVR phase correction. This means that the phase fluctuation caused by this turbulent constituent is inherently smaller than that caused by water vapor. Since in these rare cases there is no turn-over in the SSF up to the maximum baseline length of ∼15 km, this turbulent constituent must have scale height of 10 km or more, and thus cannot be water vapor, whose scale height is around 1 km. Based on the characteristics, this large scale height turbulent constituent is

  6. Baseline patient characteristics and mortality associated with longitudinal intervention compliance.

    PubMed

    Lin, Julia Y; Ten Have, Thomas R; Bogner, Hillary R; Elliott, Michael R

    2007-12-10

    Lin et al. (http://www.biostatsresearch.com/upennbiostat/papers/, 2006) proposed a nested Markov compliance class model in the Imbens and Rubin compliance class model framework to account for time-varying subject noncompliance in longitudinal randomized intervention studies. We use superclasses, or latent compliance class principal strata, to describe longitudinal compliance patterns, and time-varying compliance classes are assumed to depend on the history of compliance. In this paper, we search for good subject-level baseline predictors of these superclasses and also examine the relationship between these superclasses and all-cause mortality. Since the superclasses are completely latent in all subjects, we utilize multiple imputation techniques to draw inferences. We apply this approach to a randomized intervention study for elderly primary care patients with depression.

  7. A Multiethnic Cohort in Hawaii and Los Angeles: Baseline Characteristics

    PubMed Central

    Kolonel, Laurence N.; Henderson, Brian E.; Hankin, Jean H.; Nomura, Abraham M.Y.; Wilkens, Lynne R.; Pike, Malcolm C.; Stram, Daniel O.; Monroe, Kristine R.; Earle, Maj E.; Nagamine, Faye S.

    2015-01-01

    The authors describe the design and implementation of a large multiethnic cohort established to study diet and cancer in the United States. They detail the source of the subjects, sample size, questionnaire development, pilot work, and approaches to future analyses. The cohort consists of 215,251 adult men and women (age 45–75 years at baseline) living in Hawaii and in California (primarily Los Angeles County) with the following ethnic distribution: African-American (16.3%), Latino (22.0%), Japanese-American (26.4%), Native Hawaiian (6.5%), White (22.9%), and other ancestry (5.8%). From 1993 to 1996, participants entered the cohort by completing a 26-page, self-administered mail questionnaire that elicited a quantitative food frequency history, along with demographic and other information. Response rates ranged from 20% in Latinos to 49% in Japanese-Americans. As expected, both within and among ethnic groups, the questionnaire data show substantial variations in dietary intakes (nutrients as well as foods) and in the distributions of non-dietary risk factors (including smoking, alcohol consumption, obesity, and physical activity). When compared with corresponding ethnic-specific cancer incidence rates, the findings provide tentative support for several current dietary hypotheses. As sufficient numbers of cancer cases are identified through surveillance of the cohort, dietary and other hypotheses will be tested in prospective analyses. PMID:10695593

  8. Baseline Characteristics and Treatment Preferences of Oral Surgery Subjects

    PubMed Central

    Atchison, Kathryn A.; Gironda, Melanie W.; Black, Edward E.; Schweitzer, Stuart; Der-Martirosian, Claudia; Felsenfeld, Alan; Leathers, Richard; Belin, Thomas R.

    2009-01-01

    Background Patient preferences for treatment choices may depend on subject characteristics. Objective Using Standard Gamble (SG) and Willingness to Pay (WTP), this study compares preferences for treatment of mandibular fracture among patients in a low-income urban area. Patients and Methods Surveys of African American and Hispanic adults receiving treatment at King/Drew Medical Center for either a mandibular fracture (n=98) or third-molar removal (n=105) are used to investigate differences in patient characteristics across treatment groups (third-molar vs. fracture) and treatment preference (wiring vs. surgery). Results Fracture patients were willing to pay more to restore function without scarring or nerve damage than third-molar patients. Subjects who chose surgery were willing to accept a greater risk of possible nerve damage or scarring than those who chose wiring. Among 15 potential predictors of SG and WTP studied in 4 subgroups defined by actual treatment and treatment preference, significant predictors varied with associations for education and clinical experience for SG, and income and psychosocial predictors for WTP. Conclusions SG and WTP capture different domains of health values among subjects. There is considerable heterogeneity in relationships between patient characteristics and patient preferences across subgroups defined by actual treatment and treatment preferences. PMID:18022465

  9. Fasting glycaemia to simplify screening for gestational diabetes.

    PubMed

    Ryser Rüetschi, J; Jornayvaz, F R; Rivest, R; Huhn, E A; Irion, O; Boulvain, M

    2016-12-01

    Recommendations in Switzerland on screening for gestational diabetes endorse the International Association of Diabetes in Pregnancy Study Group consensus. As universal testing is time consuming and glucose loading is unpleasant, the recommendations include a simplification, not performing the glucose loading in women with fasting glycaemia <4.4 mmol/l. Our objective was to evaluate the diagnostic performance of this simplified strategy, compared with the complete test, in our population with a low prevalence of gestational diabetes. We collected 2298 complete 75-g glucose tolerance tests. We simulated stopping the test, so avoiding the glucose loading and further glycaemia, if fasting glycaemia was <4.4 or ≥5.1 mmol/l. Unselected pregnant women from Geneva and Basel, at 24-28 weeks of gestation. We calculated the sensitivity, and the percentage of women who would avoid the complete test with the strategy based on fasting glycaemia. The prevalence of gestational diabetes was 10.9% in our population. Among 251 women with gestational diabetes, fasting glycaemia was ≥5.1 mmol/l in 119 women (47.4%), between 4.4 and <5.1 mmol/l in 78 women (31.1%) and <4.4 mmol/l in 54 women (21.5%). Proceeding with the complete test only in women with fasting glycaemia between 4.4 and <5.1 mmol/l will result in a sensitivity of 78.5%. This strategy would avoid glucose loading in 63.8% of women. Screening with fasting glycaemia is an attractive alternative to universal screening with the complete 75-g glucose tolerance test. This strategy is, however, slightly less sensitive than previously reported in higher-risk populations. Fasting glycaemia can be considered as an alternative to the complete test for gestational diabetes screening. © 2016 Royal College of Obstetricians and Gynaecologists.

  10. Impact of postprandial glycaemia on health and prevention of disease

    PubMed Central

    Blaak, E E; Antoine, J-M; Benton, D; Björck, I; Bozzetto, L; Brouns, F; Diamant, M; Dye, L; Hulshof, T; Holst, J J; Lamport, D J; Laville, M; Lawton, C L; Meheust, A; Nilson, A; Normand, S; Rivellese, A A; Theis, S; Torekov, S S; Vinoy, S

    2012-01-01

    Postprandial glucose, together with related hyperinsulinemia and lipidaemia, has been implicated in the development of chronic metabolic diseases like obesity, type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). In this review, available evidence is discussed on postprandial glucose in relation to body weight control, the development of oxidative stress, T2DM, and CVD and in maintaining optimal exercise and cognitive performance. There is mechanistic evidence linking postprandial glycaemia or glycaemic variability to the development of these conditions or in the impairment in cognitive and exercise performance. Nevertheless, postprandial glycaemia is interrelated with many other (risk) factors as well as to fasting glucose. In many studies, meal-related glycaemic response is not sufficiently characterized, or the methodology with respect to the description of food or meal composition, or the duration of the measurement of postprandial glycaemia is limited. It is evident that more randomized controlled dietary intervention trials using effective low vs. high glucose response diets are necessary in order to draw more definite conclusions on the role of postprandial glycaemia in relation to health and disease. Also of importance is the evaluation of the potential role of the time course of postprandial glycaemia. PMID:22780564

  11. Impact of baseline characteristics on outcomes of carotid artery stenting in acute ischemic stroke patients

    PubMed Central

    Yu, Cheng-Sheng; Lin, Chih-Ming; Liu, Chi-Kuang; Lu, Henry Horng-Shing

    2016-01-01

    Carotid artery stenting is an effective treatment for ischemic stroke patients with moderate-to-severe carotid artery stenosis. However, the midterm outcome for patients undergoing this procedure varies considerably with baseline characteristics. To determine the impact of baseline characteristics on outcomes following carotid artery stenting, data from 107 eligible patients with a first episode of ischemic stroke were collected by retrospective chart review. A modified Rankin Scale (mRS) was used to divide patients into two baseline groups, mRS ≤2 and mRS >2. A three-step decision-tree statistical analysis was conducted. After weighting the decision-tree parameters, the following impact hierarchy was obtained: admission low-density lipoprotein, gouty arthritis, chronic kidney disease, ipsilateral common carotid artery resistance index, contralateral ophthalmic artery resistance index, sex, and dyslipidemia. The finite-state machine model demonstrated that, in patients with baseline mRS ≤2, 46% had an improved mRS score at follow-up, whereas 54% had a stable mRS score. In patients with baseline mRS >2, a stable mRS score was observed in 75%, improved score in 23%, and a poorer score in 2%. Admission low-density lipoprotein was the strongest predictive factor influencing poststenting outcome. In addition, our study provides further evidence that carotid artery stenting can be of benefit in first-time ischemic stroke patients with baseline mRS scores >2. PMID:27099508

  12. The primary care osteoporosis risk of fracture screening (POROS) study: design and baseline characteristics.

    PubMed

    Schneider, Diane L; Worley, Karen; Beard, Mary K; Iannini, Mark; Ko, Marcia; McCallum, James; Pulicharam, Riya; Steinbuch, Michael

    2010-07-01

    POROS evaluates a 3-step fracture risk screening program in women 50-64 not previously diagnosed with osteoporosis. This report details the research design and baseline characteristics. Recruiting from 6 primary care sites, baseline characteristics, including fracture risk factors, were assessed via self-administered questionnaires (SAQs). Subjects with >or=1 risk factor were randomized to Intervention or Non-Intervention. Those without any risk factors were placed in the No Risk Factors group. Bone turnover was measured in the Intervention group via urine N-telopeptide (NTx) testing. Subjects with NTx>50 had central hip and spine Dual-energy X-ray Absorptiometry (dxa). All groups were followed for 24 months, completing SAQs on osteoporosis management and fractures. At baseline, comparisons were made on demographics, health status, and prevalence of fracture risk factors. 2839 women were enrolled and included in baseline analyses (1464 Intervention, 372 Non-Intervention, and 1003 No Risk Factors). The mean age was 56.1 and 81.1% were postmenopausal. As expected by randomization, the Intervention and Non-Intervention groups had similar baseline characteristics. The most commonly reported fracture risk factors were body mass index <24 kg/m(2) and needing to use arms to stand from a chair. Subjects in the No Risk Factors group were more likely to be younger, heavier, Hispanic, in good health, a non-smoker, and to drink less alcohol. A stepwise screening program, utilizing data on fracture risk factors and high bone turnover prior to obtaining central bone density, can contribute significantly to fracture risk assessment in perimenopausal and younger postmenopausal women.

  13. The Multicenter Uveitis Steroid Treatment (MUST) Trial: Rationale, Design and Baseline Characteristics

    PubMed Central

    2010-01-01

    Purpose To describe the design and methods of the Multicenter Uveitis Steroid Treatment (MUST) Trial, and the baseline characteristics of enrolled patients. Design Baseline data from a 1:1 randomized, parallel treatment design clinical trial at 23 clinical centers comparing systemic corticosteroid therapy (and immunosuppression when indicated) to fluocinolone acetonide implant placement. Methods Eligible patients have active or recently active non-infectious intermediate, posterior, or panuveitis. The study design had 90% power (two-sided type I error rate=0.05) to detect a 7.5 letter (1.5 line) difference between groups in the mean visual acuity change between baseline and two years. Secondary outcomes include ocular and systemic complications of therapy and quality of life. Baseline characteristics include demographic and clinical characteristics, quality of life, and reading center gradings of lens and fundus photos, optical coherence tomography images, and fluorescein angiograms. Results Over three years, 255 patients were enrolled (481 eyes with uveitis). At baseline, 50% of eyes with uveitis had best-corrected visual acuity worse than 20/40 (16% worse than 20/200), with a similar distribution of reduced visual acuity for intermediate uveitis and posterior or panuveitis cases. Structural complications, including macular edema (36%) and epiretinal membrane (48%), were common. Conclusions The MUST Trial will compare fluocinolone acetonide implant versus systemic therapy for management of intermediate, posterior and panuveitis. Patients with intermediate, posterior, or panuveitis enrolled in the trial had a high burden of reduced visual acuity, cataract, macular edema and epiretinal membrane; overall quality of life was lower than expected based on visual acuity. PMID:20097325

  14. Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics.

    PubMed

    Diamond, Michael P; Legro, Richard S; Coutifaris, Christos; Alvero, Ruben; Robinson, Randal D; Casson, Peter; Christman, Gregory M; Ager, Joel; Huang, Hao; Hansen, Karl R; Baker, Valerie; Usadi, Rebecca; Seungdamrong, Aimee; Bates, G Wright; Rosen, R Mitchell; Haisonleder, Daniel; Krawetz, Stephen A; Barnhart, Kurt; Trussell, J C; Jin, Yufeng; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping

    2015-04-01

    To identify baseline characteristics of women with unexplained infertility to determine whether treatment with an aromatase inhibitor will result in a lower rate of multiple gestations than current standard ovulation induction medications. Randomized, prospective clinical trial. Multicenter university-based clinical practices. A total of 900 couples with unexplained infertility. Collection of baseline demographics, blood samples, and ultrasonographic assessments. Demographic, laboratory, imaging, and survey characteristics. Demographic characteristics of women receiving clomiphene citrate (CC), letrozole, or gonadotropins for ovarian stimulation were very consistent. Their mean age was 32.2 ± 4.4 years and infertility duration was 34.7 ± 25.7 months, with 59% primary infertility. More than one-third of the women were current or past smokers. The mean body mass index (BMI) was 27 and mean antimüllerian hormone level was 2.6; only 11 women (1.3%) had antral follicle counts of <5. Similar observations were identified for hormonal profiles, ultrasound characterization of the ovaries, semen parameters, and quality of life assessments in both male and female partners. The cause of infertility in the couples recruited to this treatment trial is elusive, as the women were regularly ovulating and had evidence of good ovarian reserve both by basal FSH, antimüllerian hormone levels, and antral follicle counts; the male partners had normal semen parameters. The three treatment groups have common baseline characteristics, thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and CC treatment. NCT 01044862. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  15. Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) Trial: Baseline Characteristics

    PubMed Central

    Diamond, Michael P.; Legro, Richard S.; Coutifaris, Christos; Alvero, Ruben; Robinson, Randal D.; Casson, Peter; Christman, Gregory M.; Ager, Joel; Huang, Hao; Hansen, Karl R.; Baker, Valerie; Usadi, Rebecca; Seungdamrong, Aimee; Bates, G. Wright; Rosen, R. Mitchell; Haisonleder, Daniell; Krawetz, Stephen A.; Barnhart, Kurt; Trussell, J.C.; Jin, Yufeng; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping

    2015-01-01

    Objective To identify baseline characteristics of women with unexplained infertility to determine whether treatment with an aromatase inhibitor will result in a lower rate of multiple gestations than current standard ovulation induction medications. Design Randomized, prospective clinical trial Patients 900 couples with unexplained infertility Interventions: Ovarian stimulation with gonadotropins, clomiphene citrate, or letrozole in conjunction with intrauterine insemination. Setting Multicenter University based clinical practices. Main Outcome Measures Demographic, laboratory, imaging, and survey characteristics. Interventions Collection of baseline demographics, blood samples, and ultrasonographic assessments. Results Demographic characteristics of women receiving clomiphene citrate, letrozole, or gonadotropins for ovarian stimulation were very consistent. Their mean age was 32.2 ± 4.4 years and infertility duration was 34.7± 25.7 months, with 59% primary infertility. More than 1/3 of the women were current or past smokers. The mean BMI was 27 and mean AMH level was 2.6; only 11 women (1.3%) had antral follicle counts of less than 5. Similar observations were identified for hormonal profiles, ultrasound characterization of the ovaries, semen parameters, and quality of life assessments in both male and female partners. Conclusion The cause of infertility in the couples recruited to this treatment trial is elusive, as the women were regularly ovulating and had evidence of good ovarian reserve both by basal FSH, AMH levels, and antral follicle counts; the male partners had normal semen parameters. The three treatment subgroups have common baseline characteristics, thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and clomiphene citrate treatment. PMID:25707331

  16. Three-Dimensional Biomechanical Gait Characteristics at Baseline Are Associated With Progression to Total Knee Arthroplasty

    PubMed Central

    Hatfield, Gillian L; Stanish, William D; Hubley-Kozey, Cheryl L

    2015-01-01

    Objective To determine if baseline 3-dimensional (3-D) biomechanical gait patterns differed between those patients with moderate knee osteoarthritis (OA) who progressed to total knee arthroplasty (TKA) and those that did not, and whether these differences had predictive value. Methods Fifty-four patients with knee OA had ground reaction forces and segment motions collected during gait. 3-D hip, knee, and ankle angles and moments were calculated over the gait cycle. Amplitude and temporal waveform characteristics were determined using principal component analysis. At followup 5–8 years later, 26 patients reported undergoing TKA. Unpaired t-tests were performed on baseline demographic and waveform characteristics between TKA and no-TKA groups. Receiver operating curve analysis, stepwise discriminate analysis, and logistic regression analysis determined the combination of features that best classified TKA and no-TKA groups and their predictive ability. Results Baseline demographic, symptomatic, and radiographic variables were similar, but 7 gait variables differed (P < 0.05) between groups. A multivariate model including overall knee adduction moment magnitude, knee flexion/extension moment difference, and stance–dorsiflexion moment had a 74% correct classification rate, with no overtraining based on cross-validation. A 1-unit increase in model score increased by 6-fold the odds of progression to TKA. Conclusion In addition to the link between higher overall knee adduction magnitude and future TKA, an outcome of clear clinical importance, novel findings include altered sagittal plane moment patterns indicative of reduced ability to unload the joint during midstance. This combination of dynamic biomechanical factors had a 6-fold increased odds of future TKA; adding baseline demographic and clinical factors did not improve the model. PMID:25708360

  17. Esophageal baseline impedance levels in patients with pathophysiological characteristics of functional heartburn.

    PubMed

    Martinucci, I; de Bortoli, N; Savarino, E; Piaggi, P; Bellini, M; Antonelli, A; Savarino, V; Frazzoni, M; Marchi, S

    2014-04-01

    Recently, it has been suggested that low esophageal basal impedance may reflect impaired mucosal integrity and increased acid sensitivity. We aimed to compare baseline impedance levels in patients with heartburn and pathophysiological characteristics related to functional heartburn (FH) divided into two groups on the basis of symptom relief after proton pump inhibitors (PPIs). Patients with heartburn and negative endoscopy were treated with esomeprazole or pantoprazole 40 mg daily for 8 weeks. According to MII-pH (off therapy) analysis, patients with normal acid exposure time (AET), normal reflux number, and lack of association between symptoms and refluxes were selected; of whom 30 patients with a symptom relief higher than 50% after PPIs composed Group A, and 30 patients, matched for sex and age, without symptom relief composed Group B. A group of 20 healthy volunteers (HVs) was enrolled. For each patient and HV, we evaluated the baseline impedance levels at channel 3, during the overnight rest, at three different times. Group A (vs Group B) showed an increase in the following parameters: mean AET (1.4 ± 0.8% vs 0.5 ± 0.6%), mean reflux number (30.4 ± 8.7 vs 24 ± 6.9), proximal reflux number (11.1 ± 5.2 vs 8.2 ± 3.6), acid reflux number (17.9 ± 6.1 vs 10.7 ± 6.9). Baseline impedance levels were lower in Group A than in Group B and in HVs (p < 0.001). Evaluating baseline impedance levels in patients with heartburn and normal AET could achieve a better understanding of pathophysiology in reflux disease patients, and could improve the distinction between FH and hypersensitive esophagus. © 2014 John Wiley & Sons Ltd.

  18. Effect of atorvastatin on glycaemia progression in patients with diabetes: an analysis from the Collaborative Atorvastatin in Diabetes Trial (CARDS).

    PubMed

    Livingstone, Shona J; Looker, Helen C; Akbar, Tahira; Betteridge, D John; Durrington, Paul N; Hitman, Graham A; Neil, H Andrew W; Fuller, John H; Colhoun, Helen M

    2016-02-01

    In an individual-level analysis we examined the effect of atorvastatin on glycaemia progression in type 2 diabetes and whether glycaemia effects reduce the prevention of cardiovascular disease (CVD) with atorvastatin. The study population comprised 2,739 people taking part in the Collaborative Atorvastatin Diabetes Study (CARDS) who were randomised to receive atorvastatin 10 mg or placebo and who had post-randomisation HbA1c data. This secondary analysis used Cox regression to estimate the effect of atorvastatin on glycaemia progression, defined as an increase in HbA1c of ≥ 0.5% (5.5 mmol/mol) or intensification of diabetes therapy. Mixed models were used to estimate the effect of atorvastatin on HbA1c as a continuous endpoint. Glycaemia progression occurred in 73.6% of participants allocated placebo and 78.1% of those allocated atorvastatin (HR 1.18 [95% CI 1.08, 1.29], p < 0.001) by the end of follow-up. The HR was 1.22 (95% CI 1.19, 1.35) in men and 1.11 (95% CI 0.95, 1.29) in women (p = 0.098 for the sex interaction). A similar effect was seen in on-treatment analyses: HR 1.20 (95% CI 1.07, 1.35), p = 0.001. The net mean treatment effect on HbA1c was 0.14% (95% CI 0.08, 0.21) (1.5 mmol/mol). The effect did not increase through time. Diabetes treatment intensification alone did not differ with statin allocation. Neither baseline nor 1-year-attained HbA1c predicted subsequent CVD, and the atorvastatin effect on CVD did not vary by HbA1c change (interaction p value 0.229). The effect of atorvastatin 10 mg on glycaemia progression among those with diabetes is statistically significant but very small, is not significantly different between sexes, does not increase with duration of statin and does not have an impact on the magnitude of CVD risk reduction with atorvastatin.

  19. Baseline characteristics and treatment response of patients from the Philippines in the CHIMES study.

    PubMed

    Navarro, Jose C; Gan, Herminigildo H; Lao, Annabelle Y; Baroque, Alejandro C; Hiyadan, John H B; Chua, Carlos L; San Jose, Ma Cristina; Advincula, Joel M; Lee, Chun Fan; Bousser, Marie-Germaine; Chen, Christopher L H

    2014-10-01

    The CHIMES Study compared MLC601 with placebo in patients with ischemic stroke of intermediate severity in the preceding 72 h. Sites from the Philippines randomized 504 of 1099 (46%) patients in the study. We aimed to define the patient characteristics and treatment responses in this subgroup to better plan future trials. The CHIMES dataset was used to compare the baseline characteristics, time from stroke onset to study treatment initiation, and treatment responses to MLC601 between patients recruited from Philippines and the rest of the cohort. Treatment effect was analyzed using end-points at month 3 as described in the primary publication, that is, modified Rankin Score, National Institutes of Health Stroke Scale, and Barthel Index. The Philippine cohort was younger, had more women, worse baseline National Institutes of Health Stroke Scale, and longer time delay from stroke onset to study treatment compared with the rest of the cohort. Age (P = 0·003), baseline National Institutes of Health Stroke Scale (P < 0·001), and stroke onset to study treatment initiation (P = 0·016) were predictors of modified Rankin Score at three-months. Primary analysis of modified Rankin Score shift was in favor of MLC601 (adjusted odds ratio 1·41, 95% confidence interval 1·01-1·96). Secondary analyses were likewise in favor of MLC601 for modified Rankin Score dichotomy 0-1, improvement in National Institutes of Health Stroke Scale (total and motor scores), and Barthel Index. The treatment effects in the Philippine cohort were in favor of MLC601. This may be due to inclusion of more patients with predictors of poorer outcome. © 2014 The Authors. International Journal of Stroke published by John Wiley & Sons Ltd on behalf of World Stroke Organization.

  20. Baseline Characteristics of African Americans in the Systolic Blood Pressure Intervention Trial (SPRINT)

    PubMed Central

    Still, Carolyn H.; Craven, Timothy E.; Freedman, Barry I.; Van Buren, Peter; Sink, Kaycee M.; Killeen, Anthony A.; Bates, Jeffrey T.; Bee, Alberta; Contreras, Gabriel; Oparil, Suzanne; Pedley, Carolyn; Wall, Barry; White, Suzanne; Woods, Delia; Rodriguez, Carlos; Wright, Jackson T.

    2015-01-01

    The Systolic Blood Pressure Intervention Trial (SPRINT) will compare treatment to a systolic blood pressure goal of <120 mmHg to treatment to the currently recommended goal of <140 mmHg for effects on incident cardiovascular, renal, and neurologic outcomes including cognitive decline. Objectives The objectives of this analysis are to compare baseline characteristics of African American (AA) and non-AA SPRINT participants and explore factors associated with uncontrolled blood pressure (BP) by race. Methods SPRINT enrolled 9,361 hypertensive participants over age 50. This cross-sectional analysis examines sociodemographics, baseline characteristics, and study measures among AAs compared to non-AAs. Results AAs made up 31% of participants. AAs (compared to non-AAs) were younger and less frequently male, had less education, and were more likely uninsured or covered by Medicaid. In addition, AAs scored lower on the cognitive screening test when compared to non-AAs. Multivariable logistic regression analysis found BP control rates to <140/90 mmHg were higher for AAs who were male, had higher number of chronic diseases, were on diuretic treatment, and had better medication adherence. Conclusion SPRINT is well poised to examine the effects of SBP targets on clinical outcomes as well as predictors influencing BP control in AAs. PMID:26320890

  1. The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC): design and baseline subject characteristics.

    PubMed

    Strom, Brian L; Faich, Gerald A; Reynolds, Robert F; Eng, Sybil M; D'Agostino, Ralph B; Ruskin, Jeremy N; Kane, John M

    2008-01-01

    practice (i.e., many characteristics of a nonexperimental study). Baseline data suggest this study population has a substantial prevalence of cardiovascular risk factors. Concomitant medications were used frequently, although hyperlipidemia and hypertension may be undertreated. clinicaltrials.gov Identifier: NCT00174447.

  2. Physical Fitness of Police Academy Cadets: Baseline Characteristics and Changes During a 16-Week Academy

    PubMed Central

    Sherman, Ross A.; Crawley, William R.; Cosio-Lima, Ludmila M.

    2016-01-01

    Abstract Crawley, AA, Sherman, RA, Crawley, WR, and Cosio-Lima, LM. Physical fitness of police academy cadets: baseline characteristics and changes during a 16-week academy. J Strength Cond Res 30(5): 1416–1424, 2016—Police academies traditionally emphasize the importance of being physically fit. The purpose of this research was to determine cadet baseline physical fitness characteristics and assess effectiveness of a 16-week training program. Sixty-eight cadets (61 men, 7 women) volunteered to have baseline physical fitness characteristics assessed, and 55 cadets (49 men, 6 women) completed further testing at weeks 8 and 16. The testing comprised hand grip (strength), arm crank (upper-body power), 30 seconds Wingate (lower body power), sum of skinfolds and percentage body fat (body composition), 40-yard dash (sprint speed), 1 repetition maximum bench press (strength), T-test (agility), and sit-and-reach (flexibility). In addition, cadets completed standardized state testing (push-ups, sit-ups, vertical jump, and half-mile shuttle run). The training program consisted of 1 hour sessions, 3 d·wk−1, including aerobic, plyometrics, body weight, and resistance exercise. Significant changes were found in agility (p < 0.01), upper-body and lower-body peak power (p ≤ 0.05), sit-ups (p < 0.01), push-ups (p ≤ 0.05) across the first 8 weeks, and in agility (p ≤ 0.05), lower-body peak power (p ≤ 0.05), sit-ups (p < 0.01), push-ups (p ≤ 0.05), half-mile shuttle run (p < 0.01) across the full 16 weeks. However, none of the variables showed significant change across the second half of the program (weeks 8–16). A number of individual parameters of physical fitness showed evidence of improvement in the first 8 weeks, whereas none of the variables showed significant improvement in the second 8 weeks. This suggests modifications could be made to increase overall effectiveness of cadet physical training specifically after the 8-week mark. PMID:26466133

  3. The Ahmed Baerveldt Comparison Study: Methodology, Baseline Patient Characteristics, and Intraoperative Complications

    PubMed Central

    Barton, Keith; Gedde, Steven J.; Budenz, Donald L.; Feuer, William J.; Schiffman, Joyce

    2010-01-01

    Purpose The Ahmed Baerveldt Comparative (ABC) Study compares the long-term outcomes and complications of the Ahmed Glaucoma Valve (AGV), model FP7, and the Baerveldt Glaucoma Implant (BGI), model 101–350. Design Multicenter randomized controlled clinical trial. Participants 276 glaucoma patients at 16 clinical centers worldwide, aged 18–85 years with inadequately controlled intraocular pressure (IOP ≥ 18 mm Hg) in whom placement of an aqueous shunt was planned. Methods Study patients were randomized to undergo implantation of an AGV or a BGI. Main Outcome Measure Failure, defined as IOP > 21 mm Hg or not reduced by 20% below baseline IOP ≤ 5 mm Hg (2 consecuteive visits after 3 months), additional glaucoma surgery, removal of the implant or loss of light perception vision Results A total of 276 patients were enrolled between October 2006 and April 2008, including 143 in the AGV group and 133 in the BGI group. The age of patients enrolled was 63 ± 14 years (mean ± standard deviation, SD), and 52% were male. The baseline IOP was 31.5 ± 11.8 mmHg (mean ± SD). Except for a 13% higher prevalence of hypertension in the AGV group, no significant differences in baseline demographic or ocular characteristics were observed between the study groups. Intraoperative complications occurred in 11 (8%) patients in the AGV group and 16 (12%) patients in the BGI group (p = 0.31). Conclusions The ABC study should yield valuable prospective data comparing two commonly used aqueous shunts in clinical practice. PMID:20932581

  4. Baseline Physiologic and Psychosocial Characteristics of Transgender Youth Seeking Care for Gender Dysphoria.

    PubMed

    Olson, Johanna; Schrager, Sheree M; Belzer, Marvin; Simons, Lisa K; Clark, Leslie F

    2015-10-01

    The purpose of this study was to describe baseline characteristics of participants in a prospective observational study of transgender youth (aged 12-24 years) seeking care for gender dysphoria at a large, urban transgender youth clinic. Eligible participants presented consecutively for care at between February 2011 and June 2013 and completed a computer-assisted survey at their initial study visit. Physiologic data were abstracted from medical charts. Data were analyzed by descriptive statistics, with limited comparisons between transmasculine and transfeminine participants. A total of 101 youth were evaluated for physiologic parameters, 96 completed surveys assessing psychosocial parameters. About half (50.5%) of the youth were assigned a male sex at birth. Baseline physiologic values were within normal ranges for assigned sex at birth. Youth recognized gender incongruence at a mean age of 8.3 years (standard deviation = 4.5), yet disclosed to their family much later (mean = 17.1; standard deviation = 4.2). Gender dysphoria was high among all participants. Thirty-five percent of the participants reported depression symptoms in the clinical range. More than half of the youth reported having thought about suicide at least once in their lifetime, and nearly a third had made at least one attempt. Baseline physiologic parameters were within normal ranges for assigned sex at birth. Transgender youth are aware of the incongruence between their internal gender identity and their assigned sex at early ages. Prevalence of depression and suicidality demonstrates that youth may benefit from timely and appropriate intervention. Evaluation of these youth over time will help determine the impact of medical intervention and mental health therapy. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  5. Baseline Physiologic and Psychosocial Characteristics of Transgender Youth Seeking Care for Gender Dysphoria

    PubMed Central

    Olson, Johanna; Schrager, Sheree M.; Belzer, Marvin; Simons, Lisa K.; Clark, Leslie F.

    2016-01-01

    Purpose The purpose of this study was to describe baseline characteristics of participants in a prospective observational study of transgender youth (aged 12–24 years) seeking care for gender dysphoria at a large, urban transgender youth clinic. Methods Eligible participants presented consecutively for care at between February 2011 and June 2013 and completed a computer-assisted survey at their initial study visit. Physiologic data were abstracted from medical charts. Data were analyzed by descriptive statistics, with limited comparisons between transmasculine and transfeminine participants. Results A total of 101 youth were evaluated for physiologic parameters, 96 completed surveys assessing psychosocial parameters. About half (50.5%) of the youth were assigned a male sex at birth. Baseline physiologic values were within normal ranges for assigned sex at birth. Youth recognized gender incongruence at a mean age of 8.3 years (standard deviation = 4.5), yet disclosed to their family much later (mean = 17.1; standard deviation = 4.2). Gender dysphoria was high among all participants. Thirty-five percent of the participants reported depression symptoms in the clinical range. More than half of the youth reported having thought about suicide at least once in their lifetime, and nearly a third had made at least one attempt. Conclusions Baseline physiologic parameters were within normal ranges for assigned sex at birth. Transgender youth are aware of the incongruence between their internal gender identity and their assigned sex at early ages. Prevalence of depression and suicidality demonstrates that youth may benefit from timely and appropriate intervention. Evaluation of these youth over time will help determine the impact of medical intervention and mental health therapy. PMID:26208863

  6. Baseline characteristics in stroke patients with atrial fibrillation: clinical trials versus clinical practice.

    PubMed

    Tanislav, Christian; Milde, Sonja; Schwartzkopff, Sabine; Misselwitz, Björn; Sieweke, Nicole; Kaps, Manfred

    2015-06-25

    When applying information gathered from medical research to the clinical setting, it is imperative that the sample of the investigated patients be representative of the clinical population. Because of this fact, it is necessary to closely examine the sample's baseline characteristics in clinical trials. We analysed baseline data of relevant trials investigating considerable proportions of patients with atrial fibrillation (AF) in the secondary stroke prevention: EAFT, SIFA, Active-W, BAFTA, RE-LY, AVERROES, ARISTOTLE and ROCKET AF. For comparing baseline data stroke patients with AF documented in a statutory stroke registry were considered. In a subgroup of patients (members of a large insurance) data on subsequent prescription for oral anticoagulants (oAK) were available. In the stroke registry (n = 15,886) the mean age was higher than in the selected clinical trials (mean 77.7 versus 70-72 years). Among insurance members (n = 1,828), those with a prescription for oAK (n = 827) were older than patients recruited in clinical trials (mean 75.1 versus 70-72 years). Results also showed that the male sex was overrepresented in clinical trials (59-63% versus 46%). The distribution of vascular risk factors in recent clinical trials was comparable to proportions in the registry (hypertension: 77-85% versus 80%; diabetes mellitus: 20-26% versus 27%). The majority of stroke patients with AF in the clinical setting are considerably older than those included in clinical trials. While the distribution of vascular risk factors in clinical trials corresponds to proportions observed in clinical practice, an overrepresentation of the male sex in clinical trials is evident.

  7. Treated incidence and baseline characteristics of substance induced psychosis in a Norwegian catchment area

    PubMed Central

    2013-01-01

    Background Substance misuse is a well-recognized co-morbidity to psychosis and has been linked to poor prognostic outcomes in patients. Researchers have yet to investigate the difference in rates and characteristics between first-episode Substance Induced Psychosis (SIP) and primary psychosis. We aimed at comparing patients with SIP to primary psychosis patients with or without substance misuse at baseline. Methods Thirty SIP patients, 45 primary psychosis patients with substance misuse (PS) and 66 primary psychosis patients without substance misuse (PNS) in a well-defined Norwegian catchment area were included from 2007–2011. Assessments included symptom levels (PANSS), diagnostic interviews (SCID), premorbid function scale (PAS) and global functioning (GAF f/s). Results Treated incidence for SIP was found to be 6.5/100 000 persons per year, 9.7/100 000 persons per year for PS and 24.1/100 000 persons per year for PNS (15-65 yrs). Patients who had substance misuse (PS and SIP) were more likely to be male. Duration of Untreated Psychosis (DUP) was significantly shorter in the SIP group (5.0 wks., p = 0.003) and these had more positive symptoms on the PANSS (p = 0.049). SIP patients also did poorer on early youth academic levels on the PAS. Conclusions Yearly treated incidence of SIP is 6.5/100 000 persons per year in a Norwegian catchment area. SIP patients have short DUPs, are more likely to be male, have more positive symptoms at baseline and poorer premorbid academic scores in early adolescence. Follow-up will evaluate stability of diagnosis and characteristics. PMID:24279887

  8. The Work-It Study for people with arthritis: Study protocol and baseline sample characteristics.

    PubMed

    Keysor, Julie J; AlHeresh, Rawan; Vaughan, Molly; LaValley, Michael P; Allaire, Saralynn

    2016-06-14

    People with arthritis are at risk of work disability. Job accommodation and educational programs delivered before imminent work loss can minimize work disability, yet are not currently being widely implemented. The Work-It Study is a randomized controlled trial testing the efficacy of a problem solving program delivered by physical and occupational therapy practitioners to prevent work loss over a two-year period among people with arthritis and rheumatological conditions. The purpose of this paper is to describe the protocol of the randomized controlled trial, and describe the baseline characteristics of the subjects and their work outcomes. 287 participants were recruited from the Boston area in Massachusetts, USA. Eligible participants were aged between 21-65, self-reported a physicians' diagnosis of arthritis, rheumatic condition, or chronic back pain, reported a concern about working now or in the near future due to your health, worked at least 15 hours a week, had plans to continue working, and worked or lived in Massachusetts. Subjects were recruited through community sources and rheumatology offices. Participants in the experimental group received a structured interview and an education and resource packet, while participants in the control received the resource packet only. The baseline characteristics and work related outcomes of the participants were analyzed. To our knowledge, the Work-It Study is the largest and most diverse randomized controlled trial to date aiming to identify and problem solve work-related barriers, promote advocacy, and foster work disability knowledge among people with chronic disabling musculoskeletal conditions. Despite advances in medical management of arthritis and other rheumatological and musculoskeletal conditions, many people still have concerns about their ability to remain employed and are seeking strategies to help them sustain employment.

  9. Physical Fitness of Police Academy Cadets: Baseline Characteristics and Changes During a 16-Week Academy.

    PubMed

    Crawley, Amy A; Sherman, Ross A; Crawley, William R; Cosio-Lima, Ludmila M

    2016-05-01

    Police academies traditionally emphasize the importance of being physically fit. The purpose of this research was to determine cadet baseline physical fitness characteristics and assess effectiveness of a 16-week training program. Sixty-eight cadets (61 men, 7 women) volunteered to have baseline physical fitness characteristics assessed, and 55 cadets (49 men, 6 women) completed further testing at weeks 8 and 16. The testing comprised hand grip (strength), arm crank (upper-body power), 30 seconds Wingate (lower body power), sum of skinfolds and percentage body fat (body composition), 40-yard dash (sprint speed), 1 repetition maximum bench press (strength), T-test (agility), and sit-and-reach (flexibility). In addition, cadets completed standardized state testing (push-ups, sit-ups, vertical jump, and half-mile shuttle run). The training program consisted of 1 hour sessions, 3 d·wk, including aerobic, plyometrics, body weight, and resistance exercise. Significant changes were found in agility (p < 0.01), upper-body and lower-body peak power (p ≤ 0.05), sit-ups (p < 0.01), push-ups (p ≤ 0.05) across the first 8 weeks, and in agility (p ≤ 0.05), lower-body peak power (p ≤ 0.05), sit-ups (p < 0.01), push-ups (p ≤ 0.05), half-mile shuttle run (p < 0.01) across the full 16 weeks. However, none of the variables showed significant change across the second half of the program (weeks 8-16). A number of individual parameters of physical fitness showed evidence of improvement in the first 8 weeks, whereas none of the variables showed significant improvement in the second 8 weeks. This suggests modifications could be made to increase overall effectiveness of cadet physical training specifically after the 8-week mark.

  10. Aerodynamic characteristics and pressure distributions for an executive-jet baseline airfoil section

    NASA Technical Reports Server (NTRS)

    Allison, Dennis O.; Mineck, Raymond E.

    1993-01-01

    A wind tunnel test of an executive-jet baseline airfoil model was conducted in the adaptive-wall test section of the NASA Langley 0.3-Meter Transonic Cryogenic Tunnel. The primary goal of the test was to measure airfoil aerodynamic characteristics over a wide range of flow conditions that encompass two design points. The two design Mach numbers were 0.654 and 0.735 with corresponding Reynolds numbers of 4.5 x 10(exp 6) and 8.9 x 10(exp 6) based on chord, respectively, and normal-force coefficients of 0.98 and 0.51, respectively. The tests were conducted over a Mach number range from 0.250 to 0.780 and a chord Reynolds number range from 3 x 10(exp 6) to 18 x 10(exp 6). The angle of attack was varied from -2 deg to a maximum below 10 deg with one exception in which the maximum was 14 deg for a Mach number of 0.250 at a chord Reynolds number of 4.5 x 10(exp 6). Boundary-layer transition was fixed at 5 percent of chord on both the upper and lower surfaces of the model for most of the test. The adaptive-wall test section had flexible top and bottom walls and rigid sidewalls. Wall interference was minimized by the movement of the adaptive walls, and the airfoil aerodynamic characteristics were corrected for any residual top and bottom wall interference.

  11. Lifestyle Interventions and Independence for Elders Study: Recruitment and Baseline Characteristics

    PubMed Central

    2013-01-01

    Background. Recruitment of older adults into long-term clinical trials involving behavioral interventions is a significant challenge. The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase 3 multicenter randomized controlled multisite trial, designed to compare the effects of a moderate-intensity physical activity program with a successful aging health education program on the incidence of major mobility disability (the inability to walk 400 m) in sedentary adults aged 70–89 years, who were at high risk for mobility disability (scoring ≤9 on the Short Physical Performance Battery) at baseline. Methods. Recruitment methods, yields, efficiency, and costs are described together with a summary of participant baseline characteristics. Yields were examined across levels of sex, race and ethnicity, and Short Physical Performance Battery, as well as by site. Results. The 21-month recruiting period resulted in 14,812 telephone screens; 1,635 participants were randomized (67.2% women, 21.0% minorities, 44.7% with Short Physical Performance Battery scores ≤7). Of the telephone-screened participants, 37.6% were excluded primarily because of regular participation in physical activity, health exclusions, or self-reported mobility disability. Direct mailing was the most productive recruitment strategy (59.5% of randomized participants). Recruitment costs were $840 per randomized participant. Yields differed by sex and Short Physical Performance Battery. We accrued 11% more participant follow-up time than expected during the recruitment period as a result of the accelerated recruitment rate. Conclusions. The LIFE Study achieved all recruitment benchmarks. Bulk mailing is an efficient method for recruiting high-risk community-dwelling older persons (including minorities), from diverse geographic areas for this long-term behavioral trial. PMID:23716501

  12. Advanced Imaging for Glaucoma Study: Design, Baseline Characteristics, and Inter-Site Comparison

    PubMed Central

    Le, Phuc V.; Zhang, Xinbo; Francis, Brian A.; Varma, Rohit; Greenfield, David S.; Schuman, Joel S.; Loewen, Nils; Huang, David

    2014-01-01

    Purpose To report the baseline characteristics of the participants in the Advanced Imaging for Glaucoma Study. To compare the participating sites for variations among subjects and the performance of imaging instruments. Design Multi-center longitudinal observational cohort study Methods A total of 788 participants (1,329 eyes) were enrolled from three academic referral centers. There were 145 participants (289 eyes) in the normal group, 394 participants (663 eyes) in the glaucoma suspect/preperimetric glaucoma group, and 249 participants (377 eyes) in the perimetric glaucoma group. Participants underwent a full clinical exam, standard automated perimetry, and imaging with time-domain and Fourier-domain optical coherence tomography (OCT), scanning laser polarimetry, and confocal scanning laser ophthalmoscopy. Main Outcome Measures The baseline average, population standard deviation, and repeatability of imaging-derived anatomic variables were reported for each technology and center. Results Compared to the normal participants, glaucoma suspect/preperimetric glaucoma and perimetric glaucoma groups had significantly reduced anatomic measurements. Repeatability of nerve fiber layer thickness was best for Fourier-domain OCT (overall coefficient of variation < 2%), followed by time-domain OCT (coefficient of variation 2-2.9%), scanning laser polarimetry (coefficient of variation 2.6-4.5%), and confocal scanning laser ophthalmoscopy rim area (coefficient of variation 4.2-7.6%). A mixed-effects model showed that the differences between sites was less than 25 percent of the variation within groups and less than the differences between the normal and glaucoma suspect/preperimetric glaucoma group. Conclusions Site-to-site variation was smaller than both the variation within groups and the changes due to glaucoma. Therefore pooling of participants between sites is appropriate. PMID:25447111

  13. Chronic Renal Insufficiency Cohort (CRIC) Study: Baseline Characteristics and Associations with Kidney Function

    PubMed Central

    Go, Alan S.; Appel, Lawrence J.; He, Jiang; Ojo, Akinlolu; Rahman, Mahboob; Townsend, Raymond R.; Xie, Dawei; Cifelli, Denise; Cohan, Janet; Fink, Jeffrey C.; Fischer, Michael J.; Gadegbeku, Crystal; Hamm, L. Lee; Kusek, John W.; Landis, J. Richard; Narva, Andrew; Robinson, Nancy; Teal, Valerie; Feldman, Harold I.

    2009-01-01

    Background and objectives: The Chronic Renal Insufficiency Cohort (CRIC) Study was established to examine risk factors for the progression of chronic kidney disease (CKD) and cardiovascular disease (CVD) in patients with CKD. We examined baseline demographic and clinical characteristics. Design, setting, participants, & measurements: Seven clinical centers recruited adults who were aged 21 to 74 yr and had CKD using age-based estimated GFR (eGFR) inclusion criteria. At baseline, blood and urine specimens were collected and information regarding health behaviors, diet, quality of life, and functional status was obtained. GFR was measured using radiolabeled iothalamate in one third of participants. Results: A total of 3612 participants were enrolled with mean age ± SD of 58.2 ± 11.0 yr; 46% were women, and 47% had diabetes. Overall, 45% were non-Hispanic white, 46% were non-Hispanic black, and 5% were Hispanic. Eighty-six percent reported hypertension, 22% coronary disease, and 10% heart failure. Mean body mass index was 32.1 ± 7.9 kg/m2, and 47% had a BP >130/80 mmHg. Mean eGFR was 43.4 ± 13.5 ml/min per 1.73 m2, and median (interquartile range) protein excretion was 0.17 g/24 h (0.07 to 0.81 g/24 h). Lower eGFR was associated with older age, lower socioeconomic and educational level, cigarette smoking, self-reported CVD, peripheral arterial disease, and elevated BP. Conclusions: Lower level of eGFR was associated with a greater burden of CVD as well as lower socioeconomic and educational status. Long-term follow-up of participants will provide critical insights into the epidemiology of CKD and its relationship to adverse outcomes. PMID:19541818

  14. Kids and Adults Now! Defeat Obesity (KAN-DO): Rationale, Design and Baseline Characteristics

    PubMed Central

    Østbye, Truls; Zucker, Nancy; Krause, Katrina M.; Lovelady, Cheryl A.; Evenson, Kelly; Peterson, Bercedis L.; Bastian, Lori A.; Swamy, Geeta K.; West, Deborah J; Brouwer, Rebecca JN

    2011-01-01

    Background Prevention of childhood obesity is a public health priority. Parents influence a child’s weight by modeling healthy behaviors, controlling food availability and activity opportunities, and appropriate feeding practices. Thus interventions should target education and behavioral change in the parent, and positive, mutually reinforcing behaviors within the family. Methods This paper presents the design, rationale and baseline characteristics of Kids and Adults Now! – Defeat Obesity (KAN-DO), a randomized controlled behavioral intervention trial targeting weight maintenance in children of healthy weight, and weight reduction in overweight children. 400 children aged 2–5 and their overweight or obese mothers in the Triangle and Triad regions of North Carolina are randomized equally to control or the KAN-DO intervention, consisting of mailed family kits encouraging healthy lifestyle change. Eight (monthly) kits are supported by motivational counseling calls and a single group session. Mothers are targeted during a hypothesized “teachable moment” for health behavior change (the birth of a new baby), and intervention content addresses: parenting skills (emotional regulation, authoritative parenting), healthy eating, and physical activity. Results The 400 mother-child dyads randomized to trial are 75% white and 22% black; 19% have a household income of $30,000 or below. At baseline, 15% of children are overweight (85th–95th percentile for body mass index) and 9% are obese (≥95th percentile). Conclusion This intervention addresses childhood obesity prevention by using a family-based, synergistic approach, targeting at-risk children and their mothers during key transitional periods, and enhancing maternal self-regulation and responsive parenting as a foundation for health behavior change. PMID:21300177

  15. Childhood Development after Cochlear Implantation (CDaCI) study: design and baseline characteristics.

    PubMed

    Fink, Nancy E; Wang, Nae-Yuh; Visaya, Jiovani; Niparko, John K; Quittner, Alexandra; Eisenberg, Laurie S; Tobey, Emily A

    2007-06-01

    is also lower than the NH parents. Assessments of cognition suggest that there may be baseline differences between the CI and NH children; however the scores were high enough to suggest language learning potential. The observed group differences identified these baseline characteristics as potential confounders which may require adjustment in analyses of outcomes. This longitudinal cohort study addresses questions related to high variability in language outcomes. Identifying sources of that variance requires research designs that: characterise potential predictors with accuracy, use samples that adequately power a study, and employ controls and approaches to analysis that limit bias and error. The CDaCI study was designed to generate a more complete picture of the interactive processes of language learning after implantation. 2007 John Wiley & Sons, Ltd.

  16. Baseline observations from the POSSIBLE EU® study: characteristics of postmenopausal women receiving bone loss medications

    PubMed Central

    Cooper, Cyrus; Roux, Christian; Díez-Pérez, Adolfo; Guillemin, Francis; Jonsson, Bengt; Ortolani, Sergio; Pfeilschifter, Johannes; Horne, Rob; Kakad, Shilpa; Shepherd, Susan; Möller, Gerd; Marciniak, Anne; Martinez, Luc

    2010-01-01

    Summary Prospective Observational Scientific Study Investigating Bone Loss Experience in Europe (POSSIBLE EU®) is an ongoing longitudinal cohort study that utilises physician- and patient-reported measures to describe the characteristics and management of postmenopausal women on bone loss therapies. We report the study design and baseline characteristics of 3,402 women recruited from general practice across five European countries. Purpose The POSSIBLE EU® is a study describing the characteristics and management of postmenopausal women receiving bone loss medications. Methods Between 2005 and 2008, general practitioners enrolled postmenopausal women initiating, switching or continuing treatment with bone loss treatment in France, Germany, Italy, Spain and the UK. Patients and physicians completed questionnaires at study entry and at 3-month intervals, for 1 year. Results Of 3,402 women enrolled (mean age 68.2 years [SD] 9.83), 96% were diagnosed with low bone mass; 55% of these using dual energy X-ray absorptiometry. Most women (92%) had comorbidities. Mean minimum T score (hip or spine) at diagnosis was −2.7 (SD 0.89; median −2.7 [interquartile range, −3.2, −2.2]) indicating low bone mineral density. Almost 40% of the women had prior fractures in adulthood, mostly non-vertebral, non-hip in nature, 30% of whom had at least two fractures and more than half experienced moderate/severe pain or fatigue. Bisphosphonates were the most common type of bone loss treatment prescribed in the 12 months preceding the study. Conclusions POSSIBLE EU® characterises postmenopausal women with low bone mass, exhibiting a high rate of prevalent fracture, substantial bone fragility and overall comorbidity burden. Clinical strategies for managing osteoporosis in this population varied across the five participating European countries, reflecting their different guidelines, regulations and standards of care. PMID:21258637

  17. Baseline Characteristics and Risk Factors of Pulmonary Arterial Hypertension in Systemic Lupus Erythematosus Patients.

    PubMed

    Huang, Can; Li, Mengtao; Liu, Yongtai; Wang, Qian; Guo, Xiaoxiao; Zhao, Jiuliang; Lai, Jinzhi; Tian, Zhuang; Zhao, Yan; Zeng, Xiaofeng

    2016-03-01

    Peking Union Medical College Hospital (PUMCH) has started a single-center right heart catheterization (RHC)-based pulmonary arterial hypertension (PAH) study in systemic lupus erythematosus (SLE) since 2006. The baseline characteristics of these patients were described and the risk factor for PAH in lupus was identified.The demographic, clinical, laboratory, and treatment characteristics of SLE patients with PAH when they were registered were collected as the baseline data. A case-control study was conducted by taking the admitted SLE-non-PAH patients adjusted for age and gender in a 4:1 ratio during the same period as the controls. The associated variables were examined by binary multivariate logistic regression analysis to identify possible risk factors. A total of 111 RHC-confirmed SLE-PAH patients were enrolled, with the onset age of 34.6 ± 8.6 years old and the average SLE duration of 5 years. RHC revealed mPAP as 46.4 ± 11.4 mm Hg, CI as 2.7 ± 0.8 L/min × m, and PVR as 10.5 ± 4.8 WU. 46% of patients were WHO Fc I-II. All patients were treated with immunosuppressive agents and 65% patients had PAH-targeted therapy. The case-control study had confirmed 2 independent risk factors previously published: pericardial effusion (OR = 21.290, P < 0.001) and anti-RNP antibody (OR = 12.399, P < 0.001). Meanwhile, 6 independent variables were discovered: baseline SLE duration (OR = 1.118, P = 0.007), interstitial lung disease (OR = 17.027, P < 0.001=, without acute rash (OR = 3.258, P = 0.019), anti-SSA antibody (OR = 4.836, P = 0.004), SLEDAI≤9 (OR = 26.426, P < 0.001), ESR≤20 mm/h (OR = 12.068, P < 0.001), and uric acid > 357 μmol/L (OR = 9.666, P < 0.001) to be associated with PAH in SLE patients.The PUMCH study has shown that SLE patients complicated with PAH are usually earlier diagnosed and have less disease severity than patients without PAH. The

  18. The benign prostatic hyperplasia registry and patient survey: study design, methods and patient baseline characteristics.

    PubMed

    Roehrborn, Claus G; Nuckolls, James G; Wei, John T; Steers, William

    2007-10-01

    To describe the design and baseline cohort characteristics of the Benign Prostatic Hyperplasia (BPH) Registry and Patient Survey, an ongoing, prospective, observational, disease registry documenting management practices and patient outcomes in men in the USA with lower urinary tract symptoms associated with BPH (LUTS/BPH) in actual clinical practice settings. Men with LUTS/BPH who were either untreated or treated with alpha(1)-adrenergic blockers (ABs), 5alpha-reductase inhibitors (5ARIs), a combination of these medications, or anticholinergics, and who met selection criteria, were enrolled at sites throughout the USA. At each visit, standardized forms and validated questionnaires were completed to assess the physicians' management practices and patients' clinical characteristics, sexual function, and health-related quality of life. At the close of recruitment (February 2005), 6909 men (mean age 66.0 years) were enrolled at 402 sites by urologists and primary-care physicians. Before enrolment, 49% of the men were managed with watchful waiting (WW), 21% with uroselective AB monotherapy, 11% with non-uroselective AB monotherapy, 6% with 5ARI monotherapy, 11% with AB + 5ARI, and 2% with anticholinergics. After enrolment, 42% were on WW and 26% were on selective AB monotherapy; changes in other management groups were minimal. Overall, 33% of the men had mild, 52% had moderate and 15% had severe LUTS. The most common comorbidities were hypertension (53%), high cholesterol (45%) and sexual dysfunction (36%). The BPH Registry and Patient Survey will provide information on physician management practices and outcomes of men with LUTS/BPH, while examining the effects of demographics, socio-economics, comorbidities, and medical therapies.

  19. AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT): Rationale, Design, and Baseline Characteristics

    PubMed Central

    Smurzynski, Marlene; Collier, Ann C.; Koletar, Susan L.; Bosch, Ronald J.; Wu, Kunling; Bastow, Barbara; Benson, Constance A.

    2009-01-01

    Purpose ALLRT is a longitudinal cohort study of HIV-infected subjects prospectively randomized into selected clinical trials for antiretroviral (ARV) treatment-naïve and ARV treatment-experienced individuals conducted by the AIDS Clinical Trials Group (ACTG). We describe the rationale, design, and baseline characteristics of the ALLRT cohort and its potential to address important research questions related to ARV therapy. Method Standardized visits occur every 16 weeks to evaluate long-term clinical, virologic, and immunologic outcomes associated with ARV treatment. Results A total of 4,371 subjects enrolled in ALLRT from January 2000 through June 2007. Of these, 3,146 (72%) were ARV naïve at parent study entry (18% female, 44% white, 32% black, 21% Hispanic; median age 37 years, CD4 count 218 cells/μL, follow-up 3.6 years; 343 [11%] followed ≥8 years) and 1,225 (28%) were treatment experienced (13% female, 59% white, 20% black, 17% Hispanic; median age 42 years, CD4 count 325 cells/μL, follow-up 5.7 years). Conclusions ALLRT provides the opportunity to understand long-term ramifications of therapeutic ARV choices and determine whether these vary by treatment regimen, timing of treatment initiation, or treatment changes over long-term follow-up. Investigations based on uniform data and specimen collection in the context of randomized ARV treatments will be critical to developing more successful long-term therapeutic strategies for HIV treatment. PMID:18753121

  20. Hearing aid effectiveness after aural rehabilitation - individual versus group (HEARING) trial: RCT design and baseline characteristics

    PubMed Central

    2009-01-01

    Background Hearing impairment is the most common body system disability in veterans. In 2008, nearly 520,000 veterans had a disability for hearing loss through the Department of Veterans Affairs (VA). Changes in eligibility for hearing aid services, along with the aging population, contributed to a greater than 300% increase in the number of hearing aids dispensed from 1996 to 2006. In 2006, the VA committed to having no wait times for patient visits while providing quality clinically-appropriate care. One approach to achieving this goal is the use of group visits as an alternative to individual visits. We sought to determine: 1) if group hearing aid fitting and follow-up visits were at least as effective as individual visits, and 2) whether group visits lead to cost savings through the six month period after the hearing aid fitting. We describe the rationale, design, and characteristics of the baseline cohort of the first randomized clinical trial to study the impact of group versus individual hearing aid fitting and follow-up visits. Methods Participants were recruited from the VA Puget Sound Health Care System Audiology Clinic. Eligible patients had no previous hearing aid use and monaural or binaural air-conduction hearing aids were ordered at the evaluation visit. Participants were randomized to receive the hearing aid fitting and the hearing aid follow-up in an individual or group visit. The primary outcomes were hearing-related function, measured with the first module of the Effectiveness of Aural Rehabilitation (Inner EAR), and hearing aid adherence. We tracked the total cost of planned and unplanned audiology visits over the 6-month interval after the hearing aid fitting. Discussion A cohort of 659 participants was randomized to receive group or individual hearing aid fitting and follow-up visits. Baseline demographic and self-reported health status and hearing-related measures were evenly distributed across the treatment arms. Outcomes after the 6-month

  1. Hearing aid effectiveness after aural rehabilitation - individual versus group (HEARING) trial: RCT design and baseline characteristics.

    PubMed

    Collins, Margaret P; Souza, Pamela E; Liu, Chuan-Fen; Heagerty, Patrick J; Amtmann, Dagmar; Yueh, Bevan

    2009-12-15

    Hearing impairment is the most common body system disability in veterans. In 2008, nearly 520,000 veterans had a disability for hearing loss through the Department of Veterans Affairs (VA). Changes in eligibility for hearing aid services, along with the aging population, contributed to a greater than 300% increase in the number of hearing aids dispensed from 1996 to 2006. In 2006, the VA committed to having no wait times for patient visits while providing quality clinically-appropriate care. One approach to achieving this goal is the use of group visits as an alternative to individual visits. We sought to determine: 1) if group hearing aid fitting and follow-up visits were at least as effective as individual visits, and 2) whether group visits lead to cost savings through the six month period after the hearing aid fitting. We describe the rationale, design, and characteristics of the baseline cohort of the first randomized clinical trial to study the impact of group versus individual hearing aid fitting and follow-up visits. Participants were recruited from the VA Puget Sound Health Care System Audiology Clinic. Eligible patients had no previous hearing aid use and monaural or binaural air-conduction hearing aids were ordered at the evaluation visit. Participants were randomized to receive the hearing aid fitting and the hearing aid follow-up in an individual or group visit. The primary outcomes were hearing-related function, measured with the first module of the Effectiveness of Aural Rehabilitation (Inner EAR), and hearing aid adherence. We tracked the total cost of planned and unplanned audiology visits over the 6-month interval after the hearing aid fitting. A cohort of 659 participants was randomized to receive group or individual hearing aid fitting and follow-up visits. Baseline demographic and self-reported health status and hearing-related measures were evenly distributed across the treatment arms.Outcomes after the 6-month follow-up period are needed to

  2. Baseline characteristics, chromosomal alterations, and treatment affecting prognosis of deletion 17p in newly diagnosed myeloma.

    PubMed

    Merz, Maximilian; Hielscher, Thomas; Seckinger, Anja; Hose, Dirk; Mai, Elias K; Raab, Marc S; Goldschmidt, Hartmut; Jauch, Anna; Hillengass, Jens

    2016-11-01

    Deletion 17p13, del(17p), is associated with poor outcome in myeloma but some patients show long-term survival. With the current study we intended to identify factors impacting outcome of such high risk patients. We analyzed 110 newly diagnosed, symptomatic patients with del(17p) detected by fluorescence in situ hybridization (FISH) in CD138-purified myeloma cells to identify prognostic factors for survival. Age >65 years, ISS III, and elevated LDH negatively impacted survival. Patients with subclonal (10-60% of plasma cells) del(17p) had longer progression-free survival (PFS) than patients with del(17p) in >60% of plasma cells (26 vs. 19 months, P = 0.03). Additional gain of 1q21 was associated with shorter PFS (17 vs. 25 months, P = 0.01). Hyperdiploidy did not ameliorate impact of del(17p), but gain 19q13 predicted longer PFS (30 vs. 18 months, P = 0.01) and overall survival (50 vs. 29 months, P = 0.01). Multivariate analysis in transplant eligible patients (≤65 years) revealed better survival for patients treated with upfront autologous transplantation (hazard ratio, [95% confidence interval]: 0.15 [0.04, 0.58], P = 0.006). Application of maintenance therapy was associated with better survival in transplant-eligible patients (0.30 [0.09, 0.99], P = 0.05). We demonstrate heterogeneous outcome of patients with del(17p) according to baseline characteristics and treatment. 19q13 should be included in routine FISH panel, since gains were associated with better survival. Am. J. Hematol. 91:E473-E477, 2016. © 2016 Wiley Periodicals, Inc.

  3. Baseline Characteristics of the Infant Aphakia Treatment Study Population: Predicting Recognition Acuity at 4.5 Years of Age

    PubMed Central

    Hartmann, E. Eugenie; Lynn, Michael J.; Lambert, Scott R.

    2015-01-01

    Purpose. To identify patient baseline characteristics that predict recognition acuity at 4.5 years of age in the Infant Aphakia Treatment Study, a study of patients with monocular infantile cataracts. Methods. We analyzed baseline characteristics of the 114 infants enrolled in the Infant Aphakia Treatment Study to determine which were most predictive of visual outcome at 4.5 years of age. All infants underwent cataract surgery between 1 and 7 months of age. Monocular acuity was assessed at 4.5 years of age by a traveling examiner using the Amblyopia Treatment Study HOTV protocol. Results. Age at cataract surgery was weakly associated with visual acuity (Spearman rank correlation coefficient = 0.19, P = 0.041) with median visual acuity better among the younger patients (28–48 days: 0.50 logMAR, 49–210 days: 1.10 logMAR, P = 0.046). Patients from families with private insurance had significantly better median visual acuity (0.60 vs. 1.40 logMAR, P = 0.0004). No other baseline characteristic revealed a significant bivariate relationship with visual acuity. A multiple linear regression relating visual acuity to all baseline characteristics demonstrated that only the availability of private insurance was statistically significant, accounting for 12% of the variance. Conclusions. This analysis concurs with previous studies that early surgery is important for good visual outcomes in patients with unilateral infantile cataracts. The fact that only one baseline variable (private insurance) contributed to the multivariate analysis, accounting for 12% of the variance, suggests that predicting visual outcome for these patients is complicated at best, and cannot be estimated from baseline characteristics alone. (ClinicalTrials.gov number, NCT00212134.) PMID:25503455

  4. The baseline characteristics of parents and African American girls in an online obesity prevention program: A feasibility study

    USDA-ARS?s Scientific Manuscript database

    The purpose of the study was to identify the relationships and associations between child and parent baseline characteristics with child fruit and vegetable (FV) consumption in an online obesity prevention program for 8-10 year old African American girls. Girls and a parent (n=342 child-parent pairs...

  5. The counseling african americans to control hypertension (caatch) trial: baseline demographic, clinical, psychosocial, and behavioral characteristics

    PubMed Central

    2011-01-01

    Background Effectiveness of combined physician and patient-level interventions for blood pressure (BP) control in low-income, hypertensive African Americans with multiple co-morbid conditions remains largely untested in community-based primary care practices. Demographic, clinical, psychosocial, and behavioral characteristics of participants in the Counseling African American to Control Hypertension (CAATCH) Trial are described. CAATCH evaluates the effectiveness of a multi-level, multi-component, evidence-based intervention compared with usual care (UC) in improving BP control among poorly controlled hypertensive African Americans who receive primary care in Community Health Centers (CHCs). Methods Participants included 1,039 hypertensive African Americans receiving care in 30 CHCs in the New York Metropolitan area. Baseline data on participant demographic, clinical (e.g., BP, anti-hypertensive medications), psychosocial (e.g., depression, medication adherence, self-efficacy), and behavioral (e.g., exercise, diet) characteristics were gathered through direct observation, chart review, and interview. Results The sample was primarily female (71.6%), middle-aged (mean age = 56.9 ± 12.1 years), high school educated (62.4%), low-income (72.4% reporting less than $20,000/year income), and received Medicaid (35.9%) or Medicare (12.6%). Mean systolic and diastolic BP were 150.7 ± 16.7 mm Hg and 91.0 ± 10.6 mm Hg, respectively. Participants were prescribed an average of 2.5 ± 1.9 antihypertensive medications; 54.8% were on a diuretic; 33.8% were on a beta blocker; 41.9% were on calcium channel blockers; 64.8% were on angiotensin converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs). One-quarter (25.6%) of the sample had resistant hypertension; one-half (55.7%) reported medication non-adherence. Most (79.7%) reported one or more co-morbid medical conditions. The majority of the patients had a Charlson Co-morbidity score ≥ 2. Diabetes mellitus was

  6. Baseline demographic, anthropometric, psychosocial, and behavioral characteristics of rural, Southern women in early pregnacy

    USDA-ARS?s Scientific Manuscript database

    Beginning life in a healthy uterine environment is essential for future well-being, particularly as it relates to chronic disease risk. Baseline (early pregnancy) demographic, anthropometric (height and weight), psychosocial (depression and perceived stress), and behavioral (diet and exercise) char...

  7. BeLieving in Native Girls: Characteristics from a Baseline Assessment

    ERIC Educational Resources Information Center

    Scott, Deborah; Langhorne, Aleisha

    2012-01-01

    BeLieving In Native Girls (BLING) is a juvenile delinquency and HIV intervention at a residential boarding school for American Indian/Alaska Native adolescent girls ages 12-20 years. In 2010, 115 participants completed baseline surveys to identify risk and protective factors. Initial findings are discussed regarding a variety of topics, including…

  8. The Relationships among Individual Characteristics, High School Characteristics, and College Enrollment: Using Enrollment Propensity as a Baseline for Evaluating Strategic Enrollment Management Efforts

    ERIC Educational Resources Information Center

    Pike, Gary R.; Robbins, Kirsten

    2016-01-01

    The current study examined the relationships among student and high school characteristics and the decision to enroll in either a two- or four-year college or university. The purpose of the research was to assess the feasibility of using enrollment propensity (i.e., the likelihood of enrolling in college) as a baseline to evaluate the…

  9. Lupin and soya reduce glycaemia acutely in type 2 diabetes.

    PubMed

    Dove, Emma R; Mori, Trevor A; Chew, Gerard T; Barden, Anne E; Woodman, Richard J; Puddey, Ian B; Sipsas, Sofia; Hodgson, Jonathan M

    2011-10-01

    Addition of fibre or protein to carbohydrate-rich foods can reduce the glycaemic response to those foods. This may assist with glycaemic management in individuals with type 2 diabetes. Lupin is a legume rich in fibre and protein. We assessed the acute effects of lupin- and soya-based beverages on glucose and insulin responses in type 2 diabetic individuals. We hypothesised that the lupin and soya beverages would lower the acute glycaemic response compared with a control beverage containing no protein or fibre, and that lupin would reduce the postprandial glucose more than soya. In a randomised, controlled, cross-over trial, twenty-four diabetic adults (nineteen men and five women) attended three testing sessions, each 1 week apart. At each session, participants consumed a beverage containing 50 g glucose (control), 50 g glucose plus lupin kernel flour with 12·5 g fibre and 22 g protein (lupin), or 50 g glucose plus 12·5 g fibre and 22 g protein from soya isolates (soya). Serum glucose, insulin and C-peptide were measured periodically for 4 h following beverage consumption. Compared with the control beverage, the 4 h post-beverage glucose response was lower (P < 0·001), and the 4 h post-beverage insulin and C-peptide responses were higher (P < 0·001) for lupin and soya. Glucose (P = 0·25) and C-peptide (P = 0·07) responses did not differ significantly between lupin and soya, but lupin resulted in a lower insulin response compared with soya (P = 0·013). Adding lupin or soya to a carbohydrate-rich beverage reduces glycaemia acutely in type 2 diabetic individuals. This may have a beneficial role in glycaemic management.

  10. Design, baseline characteristics, and early findings of the MPS VI (mucopolysaccharidosis VI) Clinical Surveillance Program (CSP).

    PubMed

    Hendriksz, Christian J; Giugliani, Roberto; Harmatz, Paul; Lampe, Christina; Martins, Ana Maria; Pastores, Gregory M; Steiner, Robert D; Leão Teles, Elisa; Valayannopoulos, Vassili

    2013-03-01

    To outline the design, baseline data, and 5-year follow-up data of patients with mucopolysaccharidosis (MPS) VI enrolled in the Clinical Surveillance Program (CSP), a voluntary, multinational, observational program. The MPS VI CSP was opened in 2005 to collect, for at least 15 years, observational data from standard clinical and laboratory assessments of patients with MPS VI. Baseline and follow-up data are documented by participating physicians in electronic case report forms. Between September 2005 and March 2010 the CSP enrolled 132 patients, including 123 who received enzyme replacement therapy (ERT) with galsulfase. Median age at enrolment was 13 years (range 1-59). Mean baseline data showed impaired growth, hepatosplenomegaly, and reduced endurance and pulmonary function. The most common findings were heart valve disease (90%), reduced visual acuity (79%), impaired hearing (59%), and hepatosplenomegaly (54%). Follow-up data up to 5 years in patients with pre- and post-ERT measurements showed a decrease in urinary glycosaminoglycans and increases in height and weight in patients <16 years and suggested reductions in liver and spleen size and improvements in endurance and pulmonary function after ERT was started. Vision, hearing, and cardiac function were unchanged. Safety data were in line with previous reports. The CSP represents the largest cross-sectional study of MPS VI to date. This first report provides information on the design and implementation of the program and population statistics for several clinical variables in patients with MPS VI. Data collected over 5 years suggest that ERT provides clinical benefit and is well-tolerated with no new safety concerns.

  11. Myopia Control with Orthokeratology Contact Lenses in Spain (MCOS): Study Design and General Baseline Characteristics

    PubMed Central

    Santodomingo-Rubido, Jacinto; Villa-Collar, César; Gilmartin, Bernard; Gutiérrez-Ortega, Ramón

    2010-01-01

    Purpose Although previous studies suggest that orthokeratology contact lens wear slows eye growth in children with progressing myopia, some limitations in the methodology employed have become evident. Furthermore, the safety of this modality of visual correction has not been assessed. The study “Myopia Control with Orthokeratology Contact Lenses in Spain” (MCOS) is being conducted to compare axial length growth between white European myopic children wearing orthokeratology contact lenses (OK) and wearing distance single-vision spectacles (SV). Additionally, the incidence of adverse events and discontinuations is also recorded. We outline the methodology and baseline data adopted. Methods Subjects aged 6 to 12, with myopia ranging from 0.75 to 4.00 D and astigmatism ≤1.00 D were prospectively allocated OK or SV correction. Measurements of axial length, anterior chamber depth, corneal topography, cycloplegic autorefraction, visual acuity and corneal staining are performed at 6-month intervals. The incidence of adverse events and discontinuations are also recorded. Results Thirty one children were fitted with OK and 31 with SV correction. Eight subjects did not meet the refraction-related inclusion criteria for enrollment. No significant differences were found in baseline mean age and refractive and biometric data betwseen the two groups (P>0.05). No adverse events were found in any of the two groups at baseline. Conclusion To the authors’ knowledge, MCOS is the first prospective clinical trial to assess the safety and efficacy of orthokeratology contact lens wear to slow myopia progression vs. single-vision spectacle wear. The MCOS offers a number of notable features: prospective design; well-matched samples and high-resolution ocular biometry measures, which should collectively elucidate whether orthokeratology contact lens wear is a feasible and safe method for myopia-progression control.

  12. Proteinuric nephropathy in acquired and congenital generalized lipodystrophy: baseline characteristics and course during recombinant leptin therapy.

    PubMed

    Javor, Edward D; Moran, Stephanie Ann; Young, Janice Ryan; Cochran, Elaine K; DePaoli, Alex M; Oral, Elif Arioglu; Turman, Martin A; Blackett, Piers R; Savage, David B; O'Rahilly, Stephen; Balow, James E; Gorden, Phillip

    2004-07-01

    Generalized lipodystrophy is characterized by adipose tissue absence, hypoleptinemia, hypertriglyceridemia, insulin resistance, diabetes, hepatomegaly, and nonalcoholic steatohepatitis. In the course of recruiting patients for treatment with recombinant leptin, we were struck by the frequency and severity of proteinuria. We evaluated 25 patients with generalized lipodystrophy. Eighteen were treated with recombinant leptin, and we have followed 15 on leptin for 4-36 months. We followed renal parameters at baseline and during follow-up visits. Renal biopsies were performed as clinically indicated. At baseline, 22 of 25 patients (88%) had elevated urine albumin excretion (>30 mg/24 h), 15 (60%) had macroalbuminuria (>300 mg/24 h), and five (20%) had nephrotic-range proteinuria (>3500 mg/24 h). Twenty-three (92%) had elevated creatinine clearance (>125 ml/min.1.73 m(2)). Eleven of 15 patients (73%) treated with recombinant leptin exhibited reduction in proteinuria, associated with reduction of hyperfiltration. Four patients who did not improve are discussed individually. Renal biopsy findings were remarkable for focal segmental glomerulosclerosis in four patients, membranoproliferative glomerulonephritis in two patients, and diabetic nephropathy in one patient. In conclusion, generalized lipodystrophy is associated with proteinuria and unique renal pathologies, including focal segmental glomerulosclerosis and membranoproliferative glomerulonephritis. The majority treated with recombinant leptin demonstrated reduction in proteinuria and hyperfiltration.

  13. Do older adults with chronic low back pain differ from younger adults in regards to baseline characteristics and prognosis?

    PubMed

    Manogharan, S; Kongsted, A; Ferreira, M L; Hancock, M J

    2017-05-01

    Low back pain (LBP) in older adults is poorly understood because the vast majority of the LBP research has focused on the working aged population. The aim of this study was to compare older adults consulting with chronic LBP to middle aged and young adults consulting with chronic LBP, in terms of their baseline characteristics, and pain and disability outcomes over 1 year. Data were systematically collected as part of routine care in a secondary care spine clinic. At initial presentation patients answered a self-report questionnaire and underwent a physical examination. Patients older than 65 were classified as older adults and compared to middle aged (45-65 years old) and younger adults (17-44 years old) for 10 baseline characteristics. Pain intensity and disability were collected at 6 and 12 month follow-ups and compared between age groups. A total of 14,479 participants were included in the study. Of these 3087 (21%) patients were older adults, 6071 (42%) were middle aged and 5321 (37%) were young adults. At presentation older adults were statistically different to the middle aged and younger adults for most characteristics measured (e.g. less intense back pain, more leg pain and more depression); however, the differences were small. The change in pain and disability over 12 months did not differ between age groups. This study found small baseline differences in older people with chronic LBP compared to middle aged and younger adults. There were no associations between age groups and the clinical course. Small baseline differences exist in older people with chronic low back pain compared to middle aged and younger adults referred to secondary care for chronic low back pain. Older adults present with slightly less intense low back pain but slightly more intense leg pain. Changes in pain intensity and disability over a 12 month period were similar across all age groups. © 2017 European Pain Federation - EFIC®.

  14. Baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF).

    PubMed

    McMurray, John J V; Anand, Inder S; Diaz, Rafael; Maggioni, Aldo P; O'Connor, Christopher; Pfeffer, Marc A; Solomon, Scott D; Tendera, Michal; van Veldhuisen, Dirk J; Albizem, Moetaz; Cheng, Sunfa; Scarlata, Debra; Swedberg, Karl; Young, James B

    2013-03-01

    This report describes the baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF) which is testing the hypothesis that anaemia correction with darbepoetin alfa will reduce the composite endpoint of death from any cause or hospital admission for worsening heart failure, and improve other outcomes. Key demographic, clinical, and laboratory findings, along with baseline treatment, are reported and compared with those of patients in other recent clinical trials in heart failure. Compared with other recent trials, RED-HF enrolled more elderly [mean age 70 (SD 11.4) years], female (41%), and black (9%) patients. RED-HF patients more often had diabetes (46%) and renal impairment (72% had an estimated glomerular filtration rate < 60 mL/min/1.73 m2). Patients in RED-HF had heart failure of longer duration [5.3 (5.4) years], worse NYHA class (35% II, 63% III, and 2% IV), and more signs of congestion. Mean EF was 30% (6.8%). RED-HF patients were well treated at randomization, and pharmacological therapy at baseline was broadly similar to that of other recent trials, taking account of study-specific inclusion/exclusion criteria. Median (interquartile range) haemoglobin at baseline was 112 (106-117) g/L. The anaemic patients enrolled in RED-HF were older, moderately to markedly symptomatic, and had extensive co-morbidity.

  15. Baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF)

    PubMed Central

    McMurray, John J.V.; Anand, Inder S.; Diaz, Rafael; Maggioni, Aldo P.; O'Connor, Christopher; Pfeffer, Marc A.; Solomon, Scott D.; Tendera, Michal; van Veldhuisen, Dirk J.; Albizem, Moetaz; Cheng, Sunfa; Scarlata, Debra; Swedberg, Karl; Young, James B.; Amuchastegui, M.; Belziti, C.; Bluguermann, J.; Caccavo, M.; Cartasegna, L.; Colque, R.; Cuneo, C.; Fernandez, A.; Gabito, A.; Goicochea, R.; Gonzalez, M.; Gorosito, V.; Grinfeld, L.; Hominal, M.; Kevorkian, R.; Litvak Bruno, M.; Llanos, J.; Mackinnon, I.; Manuale, O.; Marzetti, E.; Nul, D.; Perna, E.; Riccitelli, M.; Sanchez, A.; Santos, D.; Schygiel, P.; Toblli, J.; Vogel, D.; Aggarwal, A.; Amerena, J.; De Looze, F.; Fletcher, P.; Hare, D.; Ireland, M.; Krum, H.; Lattimore, J.; Marwick, T.; Sindone, A.; Thompson, P.; Waites, J.; Altenberger, J.; Ebner, C.; Lenz, K.; Pacher, R.; Poelzl, G.; Charlier, F.; de Ceuninck, M.; De Keulenaer, G.; Dendale, P.; Maréchal, P.; Mullens, W.; Thoeng, J.; Vanderheyden, M.; Vanhaecke, J.; Weytjens, C.; Wollaert, B.; Albuquerque, D.; Almeida, D.; Aspe y Rosas, J.; Bocchi, E.; Bordignon, S.; Clausell, N.; Kaiser, S.; Leaes, P.; Martins Alves, S.; Montera, M.; Moura, L.; Pereira de Castro, R.; Rassi, S.; Reis, A.; Saraiva, J.; Simões, M.; Souza Neto, J.; Teixeira, M.; Benov, H.; Chompalova, B.; Donova, T.; Georgiev, P.; Gotchev, D.; Goudev, A.; Grigorov, M.; Guenova, D.; Hergeldjieva, V.; Ivanov, D.; Kostova, E.; Manolova, A.; Marchev, S.; Nikolov, F.; Popov, A.; Raev, D.; Tzekova, M.; Czarnecki, W.; Giannetti, N.; Haddad, H.; Heath, J.; Huynh, T.; Lepage, S.; Liu, P.; Lonn, E.; Ma, P.; Manyari, D.; Moe, G.; Parker, J.; Pesant, Y.; Rajda, M.; Ricci, J.; Roth, S.; Sestier, F.; Sluzar, V.; Sussex, B.; Vizel, S.; Antezana, G.; Bugueno, C.; Castro, P.; Conejeros, C.; Manriquez, L.; Martinez, D.; Potthoff, S.; Stockins, B.; Vukasovic, J.; Gregor, P.; Herold, M.; Jerabek, O.; Jirmar, R.; Kuchar, R.; Linhart, A.; Podzemska, B.; Soucek, M.; Spac, J.; Spacek, R.; Vodnansky, P.; Bronnum-Schou, J.; Clemmensen, K.; Egstrup, K.; Jensen, G.; Kjoller-Hansen, L.; Kober, L.; Markenvard, J.; Rokkedal, J.; Skagen, K.; Torp-Pedersen, C.; Tuxen, C.; Videbak, L.; Laks, T.; Vahula, V.; Harjola, V.; Kettunen, R.; Kotila, M.; Bauer, F.; Cohen Solal, A.; Coisne, D.; Davy, J.; De Groote, P.; Dos Santos, P.; Funck, F.; Galinier, M.; Gibelin, P.; Isnard, R.; Neuder, Y.; Roul, G.; Sabatier, R.; Trochu, J.; Anker, S.; Denny, S.; Dreykluft, T.; Flesch, M.; Genth-Zotz, S.; Hambrecht, R.; Hein, J.; Jeserich, M.; John, M.; Kreider-Stempfle, H.; Laufs, U.; Muellerleile, K.; Natour, M.; Sandri, M.; Schäufele, T.; von Hodenberg, E.; Weyland, K.; Winkelmann, B.; Tse, H.; Yan, B.; Barsi, B.; Csikasz, J.; Dezsi, C.; Edes, I.; Forster, T.; Karpati, P.; Kerekes, C.; Kis, E.; Kosa, I.; Lupkovics, G.; Nagy, A.; Preda, I.; Ronaszeki, A.; Tomcsanyi, J.; Zamolyi, K.; Agarwal, D.; Bahl, V.; Bordoloi, A.; Chockalingam, K.; Chopda, M.; Chopra, V.; Dugal, J.; Ghaisas, N.; Ghosh, S.; Grant, P.; Hiremath, S.; Iyengar, S.; Jagadeesa Subramania, B.; Jain, P.; Joshi, A.; Khan, A.; Mullasari, A.; Naik, S.; Oomman, A.; Pai, V.; Pareppally Gopal, R.; Parikh, K.; Patel, T.; Prakash, V.; Sastry, B.; Sathe, S.; Sinha, N.; Srikanthan, V.; Subburamakrishnan, P.; Thacker, H.; Wander, G.; Admon, D.; Katz, A.; Klainman, E.; Lewis, B.; Marmor, A.; Moriel, M.; Mosseri, M.; Shotan, A.; Weinstein, J.; Zimlichman, R.; Agostoni, P.; Albanese, M.; Alunni, G.; Bini, R.; Boccanelli, A.; Bolognese, L.; Campana, C.; Carbonieri, E.; Carpino, C.; Checco, L.; Cosmi, F.; D'Angelo, G.; De Cristofaro, M.; Floresta, A.; Fucili, A.; Galvani, M.; Ivleva, A.; Marra, S.; Musca, G.; Peccerillo, N.; Perrone Filardi, P.; Picchio, E.; Russo, T.; Scelsi, L.; Senni, M.; Tavazzi, L.; Erglis, A.; Jasinkevica, I.; Kakurina, N.; Veze, I.; Volans, E.; Bagdonas, A.; Berukstis, E.; Celutkiene, J.; Dambrauskaite, A.; Jarasuniene, D.; Luksiene, D.; Rudys, A.; Sakalyte, G.; Sliaziene, S.; Aguilar-Romero, R.; Cardona-Muñoz, E.; Castro-Jimenez, J.; Chavez-Herrera, J.; Chuquiure Valenzuela, E.; De la Pena, G.; Herrera, E.; Leiva-Pons, J.; Lopez Alvarado, A.; Mendez Machado, G.; Ramos-Lopez, G.; Basart, D.; Buijs, E.; Cornel, J.; de Leeuw, M.; Dijkgraaf, R.; Dunselman, P.; Freericks, M.; Hamraoui, K.; Lenderlink, T.; Linssen, G.; Lodewick, P.; Lodewijks, C.; Lok, D.; Nierop, P.; Ronner, E.; Somsen, A.; van Dantzig, J.; van der Burgh, P.; van Kempen, L.; van Vlies, B.; Voors, A.; Wardeh, A.; Willems, F.; Dickstein, K.; Gundersen, T.; Hole, T.; Thalamus, J.; Westheim, A.; Dabrowski, M.; Gorski, J.; Korewicki, J.; Kuc, K.; Miekus, P.; Musial, W.; Niegowska, J.; Piotrowski, W.; Podolec, P.; Polonski, L.; Ponikowski, P.; Rynkiewicz, A.; Szelemej, R.; Trusz-Gluza, M.; Ujda, M.; Wojciechowski, D; Wysokinski, A.; Camacho, A.; Fonseca, C.; Monteiro, P.; Apetrei, E.; Bruckner, I.; Carasca, E.; Coman, I.; Datcu, M.; Dragulescu, S.; Ionescu, P.; Iordachescu-Petica, D.; Manitiu, I.; Popa, V.; Pop-Moldovan, A.; Radoi, M.; Stamate, S.; Tomescu, M.; Vita, I.; Aroutiounov, G.; Ballyuzek, M.; Bart, B.; Churina, S.; Glezer, M.; Goloshchekin, B.; Ivleva, A.; Kobalava, Z.; Kostenko, V.; Lopatin, Y.; Martynov, A.; Orlov, V.; Semernin, E.; Shogenov, Z.; Sidorenko, B.; Skvortsov, A.; Storzhakov, G.; Sulimov, V.; Talibov, O.; Tereshenko, S.; Tsyrline, V.; Zadionchenko, V.; Zateyshchikov, D.; Dzupina, A.; Hranai, M.; Kmec, J.; Micko, K.; Murin, J.; Pella, D.; Sojka, G.; Spisak, V.; Vahala, P.; Vinanska, D.; Badat, A.; Bayat, J.; Dawood, S.; Delport, E.; Ellis, G.; Garda, R.; Klug, E.; Mabin, T.; Naidoo, D.; Pretorius, M.; Ranjith, N.; Van Zyl, L.; Weich, H.; Anguita, M.; Berrazueta, J.; Bruguera i Cortada, J.; de Teresa, E.; Gómez Sánchez, M.; González Juanatey, J.; Gonzalez-Maqueda, I.; Jordana, R.; Lupon, J.; Manzano, L.; Pascual Figal, D.; Pulpón, L.; Recio, J.; Ridocci Soriano, F.; Rodríguez Lambert, J.; Roig Minguell, E.; Roig Minguell, E.; Romero, J.; Valdovinos, P.; Klintberg, L.; Kronvall, T.; Lycksell, M.; Morner, S.; Rydberg, E.; Swedberg, K.; Timberg, I.; Wikstrom, G.; Moccetti, T.4; Ashok, J.; Banerjee, P.; Carr-White, G.; Cleland, J.; Connolly, E.; Francis, M.; Greenbaum, R.; Kadr, H.; Lindsay, S.; McMurray, J.; Megarry, S.; Memon, A.; Murdoch, D.; Senior, R.; Squire, I.; Tan, L.; Witte, K.; Adams, K.; Adamson, P.; Adler, A.; Altschul, L.; Altschuller, A.; Amirani, H.; Anand, I.; Andreou, C.; Ansari, M.; Antonishen, M.; Banchs, H.; Banerjee, S.; Banish, D.; Bank, A.; Barbagelata, A.; Barnard, D.; Bellinger, R.; Benn, A.; Berk, M.; Berry, B.; Bethala, V.; Bilazarian, S.; Bisognano, J.; Bleyer, F.; Blum, M.; Boehmer, J.; Bouchard, A.; Boyle, A.; Bozkurt, B.; Brown, C.; Burlew, B.; Burnham, K.; Butler, J.; Call, J.; Cambier, P.; Cappola, T.; Carlson, R.; Chandler, B.; Chandra, R.; Chandraratna, P.; Chernick, R.; Colan, D.; Colfer, H.; Colucci, W.; Connelly, T.; Costantini, O.; Dadkhah, S.; Dauber, I.; Davis, J.; Davis, S.; Denning, S.; Drazner, M.; Dunlap, S.; Egbujiobi, L.; Elkayam, U.; Elliott, J.; El-Shahawy, M.; Essandoh, L.; Ewald, G.; Fang, J.; Farhoud, H.; Felker, G.; Fernandez, J.; Festin, R.; Fishbein, G.; Florea, V.; Flores, E.; Floro, J.; Gabris, M.; Garg, M.; Gatewood, R.; Geller, M.; Ghali, J.; Ghumman, W.; Gibbs, G.; Gillespie, E.; Gilmore, R.; Gogia, H.; Goldberg, L.; Gradus-Pizlo, I.; Grainger, T.; Gudmundsson, G.; Gunawardena, D.; Gupta, D.; Hack, T.; Hall, S.; Hamroff, G.; Hankins, S.; Hanna, M.; Hargrove, J.; Haught, W.; Hauptman, P.; Hazelrigg, M.; Herzog, C.; Heywood, J.; Hill, T.; Hilton, T.; Hirsch, H.; Hunter, J.; Ibrahim, H.; Imburgia, M.; Iteld, B.; Jackson, B.; Jaffrani, N.; Jain, D.; Jain, A.; James, M.; Jimenez, J.; Johnson, E.; Kale, P.; Kaneshige, A.; Kapadia, S.; Karia, D.; Karlsberg, R.; Katholi, R.; Kerut, E.; Khoury, W.; Kipperman, R.; Klapholz, M.; Kosinski, E.; Kozinn, M.; Kraus, D.; Krueger, S.; Krum, H.; Kumar, S.; Lader, E.; Lee, C.; Levy, W.; Lewis, E.; Light-McGroary, K.; Loh, I.; Lombardi, W.; Machado, C.; Maislos, F.; Mancini, D.; Markus, T.; Mather, P.; McCants, K.; McGrew, F.; McLaurin, B.; McMillan, E.; McNamara, D.; Meyer, T.; Meymandi, S.; Miller, A.; Minami, E.; Modi, M.; Mody, F.; Mohanty, P.; Moscoso, R.; Moskowitz, R.; Moustafa, M.; Mullen, M.; Naz, T.; Noonan, T.; O'Brien, T.; Oellerich, W.; Oren, R.; Pamboukian, S.; Pereira, N.; Pitt, W.; Porter, C.; Prabhu, S.; Promisloff, S.; Ratkovec, R.; Richardson, R.; Ross, A.; Saleh, N.; Saltzberg, M.; Sarkar, S.; Schmedtje, J.; Schneider, R.; Schuyler, G.; Shanes, J.; Sharma, A.; Siegel, C.; Siegel, R.; Silber, D.; Singh, V.; Singh, N.; Singh, J.; Sklar, J.; Small, R.; Smith, A.; Smith, E.; Smith, E.; Smull, D.; Sotolongo, R.; Staniloae, C.; Stapleton, D.; Steele, P.; Stehlik, J.; Stein, M.; Tang, W.; Thadani, U.; Torre-Amoine, G.; Trichon, B.; Tsai, C.; Tummala, R.; Van Bakel, A.; Vicari, R.; Vijay, N.; Vijayaraghavan, K.; Vittorio, T.; Vossler, M.; Wagoner, L.; Wallis, D.; Ward, N.; Widmer, M.; Wight, J.; Wilkins, C.; Williams, C.; Williams, G.; Winchester, M.; Winkel, E.; Wittmer, B.; Wood, D.; Wormer, D.; Wright, R.; Xu, Z.; Yasin, M.; Zolty, R.

    2013-01-01

    Aims This report describes the baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF) which is testing the hypothesis that anaemia correction with darbepoetin alfa will reduce the composite endpoint of death from any cause or hospital admission for worsening heart failure, and improve other outcomes. Methods and results Key demographic, clinical, and laboratory findings, along with baseline treatment, are reported and compared with those of patients in other recent clinical trials in heart failure. Compared with other recent trials, RED-HF enrolled more elderly [mean age 70 (SD 11.4) years], female (41%), and black (9%) patients. RED-HF patients more often had diabetes (46%) and renal impairment (72% had an estimated glomerular filtration rate <60 mL/min/1.73 m2). Patients in RED-HF had heart failure of longer duration [5.3 (5.4) years], worse NYHA class (35% II, 63% III, and 2% IV), and more signs of congestion. Mean EF was 30% (6.8%). RED-HF patients were well treated at randomization, and pharmacological therapy at baseline was broadly similar to that of other recent trials, taking account of study-specific inclusion/exclusion criteria. Median (interquartile range) haemoglobin at baseline was 112 (106–117) g/L. Conclusion The anaemic patients enrolled in RED-HF were older, moderately to markedly symptomatic, and had extensive co-morbidity. PMID:23329651

  16. Effect of statin therapy on disease progression in pediatric ADPKD: design and baseline characteristics of participants.

    PubMed

    Cadnapaphornchai, Melissa A; George, Diana M; Masoumi, Amirali; McFann, Kim; Strain, John D; Schrier, Robert W

    2011-05-01

    Autosomal dominant polycystic kidney disease (ADPKD) is the most common genetic kidney condition and is associated with important renal and cardiovascular manifestations in childhood. Renal cystic disease can be documented in some cases as early as in utero. Early intervention is critical if the long-term complications of this condition, including end-stage renal disease, are to be ameliorated. Here we describe our ongoing randomized double-blind placebo-controlled phase III clinical trial to assess the effect of pravastatin treatment on renal and cardiovascular disease progression in 107 children and young adults age 8-22 years with ADPKD who are receiving the angiotensin converting enzyme inhibitor lisinopril. Baseline demographic and laboratory data are provided. Results of this study could markedly impact the standard of care for evaluation and treatment of ADPKD in this population.

  17. The American Cancer Society's Cancer Prevention Study 3 (CPS-3): Recruitment, study design, and baseline characteristics.

    PubMed

    Patel, Alpa V; Jacobs, Eric J; Dudas, Daniela M; Briggs, Peter J; Lichtman, Cari J; Bain, Elizabeth B; Stevens, Victoria L; McCullough, Marjorie L; Teras, Lauren R; Campbell, Peter T; Gaudet, Mia M; Kirkland, Elizabeth G; Rittase, Melissa H; Joiner, Nance; Diver, W Ryan; Hildebrand, Janet S; Yaw, Nancy C; Gapstur, Susan M

    2017-06-01

    Prospective cohort studies contribute importantly to understanding the role of lifestyle, genetic, and other factors in chronic disease etiology. The American Cancer Society (ACS) recruited a new prospective cohort study, Cancer Prevention Study 3 (CPS-3), between 2006 and 2013 from 35 states and Puerto Rico. Enrollment took place primarily at ACS community events and at community enrollment "drives." At enrollment sites, participants completed a brief survey that included an informed consent, identifying information necessary for follow-up, and key exposure information. They also provided a waist measure and a nonfasting blood sample. Most participants also completed a more comprehensive baseline survey at home that included extensive medical, lifestyle, and other information. Participants will be followed for incident cancers through linkage with state cancer registries and for cause-specific mortality through linkage with the National Death Index. In total, 303,682 participants were enrolled. Of these, 254,650 completed the baseline survey and are considered "fully" enrolled; they will be sent repeat surveys periodically for at least the next 20 years to update exposure information. The remaining participants (n = 49,032) will not be asked to update exposure information but will be followed for outcomes. Twenty-three percent of participants were men, 17.3% reported a race or ethnicity other than "white," and the median age at enrollment was 47 years. CPS-3 will be a valuable resource for studies of cancer and other outcomes because of its size; its diversity with respect to age, ethnicity, and geography; and the availability of blood samples and detailed questionnaire information collected over time. Cancer 2017;123:2014-2024. © 2017 American Cancer Society. © 2017 American Cancer Society.

  18. Medication Intervention for CKD patients transitioning from Hospital to Home: Study Design and Baseline Characteristics

    PubMed Central

    Alicic, Radica Z.; Short, Robert A.; Corbett, Cynthia L.; Neumiller, Joshua J.; Gates, Brian J.; Daratha, Kenn B.; Barbosa-Leiker, Celestina; McPherson, Sterling; Chaytor, Naomi S.; Dieter, Brad P; Setter, Stephen M.; Tuttle, Katherine R.

    2016-01-01

    Background The hospital readmission rate in the population with chronic kidney disease (CKD) is high and strategies to reduce this risk are urgently needed. Methods The Chronic Kidney Disease-Medication Intervention Trial (CKD-MIT) (www.clinicaltrials.gov NCTO1459770) is a single-blind (investigators), randomized, clinical trial conducted at Providence Health Care in Spokane, Washington. Study participants are hospitalized patients with CKD stages 3-5 (not treated with kidney replacement therapy) and acute illness. The study intervention is a pharmacist-led, home-based, medication management intervention delivered within 7 days after hospital discharge. The primary outcome is a composite of hospital readmissions and visits to emergency departments and urgent care centers for 90 days following hospital discharge. Secondary outcomes are achievement of guideline-based targets for CKD risk factors and complications. Results Enrollment began in February 2012 and ended in May 2015. At baseline, the age of participants was 69±11 years (mean±standard deviation), 50% (77/155) were women, 83% (117/141) had hypertension, and 56% (79/141) had diabetes. At baseline, the estimated glomerular filtration rate was 41±14 ml/min/1.73 m2 and urine albumin-to-creatinine ratio was 43 mg/g (interquartile range 8, 528 mg/g). The most frequent diagnosis category for the index hospital admission was cardiovascular diseases at 34% (53/155), but the most common single diagnosis for admission was community-acquired acute kidney injury at 10% (16/155). Conclusion Participants in CKD-MIT are typical of acutely-ill hospitalized patients with CKD. A medication management intervention after hospital discharge is under study to reduce post-hospitalization acute care utilization and improve CKD management. PMID:27487357

  19. GenSalt: rationale, design, methods and baseline characteristics of study participants.

    PubMed

    2007-08-01

    Hypertension is a complex disorder influenced by genetic and environmental determinants and their interactions. The objectives of the Genetic Epidemiology Network of Salt Sensitivity (GenSalt) are to localize and identify genes related to blood pressure (BP) responses to dietary sodium and potassium intervention. GenSalt utilizes a family feeding-study design. Each family was ascertained through a proband with untreated prehypertension or stage-1 hypertension in rural China. A medical history, lifestyle risk factors and responses to cold pressor tests, were obtained at baseline visits while BP, weight, blood and urine specimens were collected at baseline and follow-up visits. The dietary intervention included a 7-day low-sodium feeding (51.3 mmol/day), a 7-day high-sodium feeding (307.8 mmol/day) and a 7-day high-sodium feeding with an oral potassium supplementation (60 mmol/day). Microsatellite markers for genome-wide linkage scan and single nucleotide polymorphism (SNP) markers in candidate genes will be genotyped. Overall, 3153 participants from 658 families were recruited for GenSalt. The mean systolic and diastolic BPs were 128.0 and 80.3, 111.6 and 71.0, 112.6 and 72.6, 106.6 and 65.3 and 136.7 and 75.0 mm Hg for probands, siblings, spouses, offspring and parents, respectively. The mean urinary excretion of sodium and potassium were 232.5 and 38.6, 222.9 and 38.2, 213.1 and 37.8 and 207.3 and 36.0 mmol/24-h for probands, siblings, spouses and offspring, respectively. Our study will identify novel genes that influence significantly the effect of dietary sodium and potassium intake on BP. This information is useful for development of targeted intervention for the prevention and treatment of hypertension.

  20. A Prospective Study of Pravastatin in the Elderly at Risk (PROSPER): Screening Experience and Baseline Characteristics

    PubMed Central

    Ford, Ian; Blauw, Gerard Jan; Murphy, Michael B; Shepherd, James; Cobbe, Stuart M; Bollen, Edward LEM; Buckley, Brendan M; Jukema, J Wouter; Hyland, Michael; Gaw, Allan; Lagaay, A Margot; Perry, Ivan J; Macfarlane, Peter; Norrie, John; Meinders, A Edo; Sweeney, Brian J; Packard, Chris J; Westendorp, Rudi GJ; Twomey, Cillian; Stott, David J

    2002-01-01

    Background PROSPER was designed to investigate the benefits of treatment with pravastatin in elderly patients for whom a typical doctor might consider the prescription of statin therapy to be a realistic option. Methods The PROspective Study of Pravastatin in the Elderly at Risk (PROSPER) is a randomised, double blind, placebo-controlled trial to test the hypothesis that treatment with pravastatin (40 mg/day) will reduce the risk of coronary heart disease death, non-fatal myocardial infarction, and fatal or non-fatal stroke in elderly men and women with pre-existing vascular disease or with significant risk of developing this condition. Results In Scotland, Ireland, and the Netherlands, 23,770 individuals were screened, and 5,804 subjects (2,804 men and 3,000 women), aged 70 to 82 years (average 75 years) and with baseline cholesterol 4.0–9.0 mmol/l, were randomised. Randomised subjects had similar distributions with respect to age, blood pressure, and body mass index when compared to the entire group of screenees, but had a higher prevalence of smoking, diabetes, hypertension, and a history of vascular disease. The average total cholesterol level at baseline was 5.4 mmol/l (men) and 6.0 mmol/l (women). Conclusions Compared with previous prevention trials of cholesterol-lowering drugs, the PROSPER cohort is significantly older and for the first time includes a majority of women. The study, having achieved its initial goal of recruiting more than 5,500 elderly high-risk men and women, aims to complete all final subject follow-up visits in the first half of 2002 with the main results being available in the fourth quarter of 2002. PMID:12097148

  1. Characteristics of Treatment Seeking Finnish Pathological Gamblers: Baseline Data from a Treatment Study

    ERIC Educational Resources Information Center

    Lahti, Tuuli; Halme, Jukka; Pankakoski, Maiju; Sinclair, David; Alho, Hannu

    2013-01-01

    This article describes the socio-demographic characteristics and gambling behavior of 39 pathological gamblers who participated in our treatment study in 2009. The inclusion criteria of the study were: score of five or more on both the South Oaks Gambling Screen (SOGS) and a pathological gambling screen based on the Diagnostic and Statistical…

  2. Characteristics of Treatment Seeking Finnish Pathological Gamblers: Baseline Data from a Treatment Study

    ERIC Educational Resources Information Center

    Lahti, Tuuli; Halme, Jukka; Pankakoski, Maiju; Sinclair, David; Alho, Hannu

    2013-01-01

    This article describes the socio-demographic characteristics and gambling behavior of 39 pathological gamblers who participated in our treatment study in 2009. The inclusion criteria of the study were: score of five or more on both the South Oaks Gambling Screen (SOGS) and a pathological gambling screen based on the Diagnostic and Statistical…

  3. The Atorvastatin/Donepezil in Alzheimer's Disease Study (LEADe): design and baseline characteristics.

    PubMed

    Jones, Roy W; Kivipelto, Miia; Feldman, Howard; Sparks, Larry; Doody, Rachelle; Waters, David D; Hey-Hadavi, Judith; Breazna, Andrei; Schindler, Rachel J; Ramos, Harry

    2008-03-01

    Growing evidence suggests that elevated cholesterol levels in mid-life are associated with increased risk of developing Alzheimer's disease (AD), and that statins might have a protective effect against AD and dementia. The Lipitor's Effect in Alzheimer's Dementia (LEADe) study tests the hypothesis that a statin (atorvastatin 80 mg daily) will provide a benefit on the course of mild to moderate AD in patients receiving background therapy of a cholinesterase inhibitor (donepezil 10 mg daily). This is an international, multicenter, double-blind, randomized, parallel-group study with a double-blind randomized withdrawal phase of patients with mild to moderate AD (Mini-Mental State Examination [MMSE] score, 13 to 25). Inclusion criteria included age 50 to 90 years, receiving donepezil 10 mg for at least 3 months before randomization, and low-density lipoprotein cholesterol levels (LDL-C) 2.5 to 3.5 mmol/L (95 to 195 mg/dL). Co-primary end points are changes in AD Assessment Scale-cognitive subscale (ADAS-cog) and AD Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) scale scores. A confirmatory end point is rate of change in whole brain and hippocampal volumes in patients who enrolled in the magnetic resonance imaging substudy. Enrollment of 641 subjects is complete. The baseline mean data are age 74 +/- 8 years, 53% women, MMSE 22 +/- 3, ADAS-cog 23 +/- 10, AD Functional Assessment and Change Scale (ADFACS) 13 +/- 9, Neuropsychiatric Inventory (NPI) 10 +/- 11, and Clinical Dementia Rating-Sum of Boxes (CDR-SB) 6 +/- 3. Mean prior donepezil treatment was 409 +/- 407 days. Mean baseline lipid levels are total cholesterol 5.8 +/- 0.8 mmol/L (224 +/- 33 mg/dL), LDL-C 3.7 +/- 0.7 mmol/L (143 +/- 26 mg/dL), triglycerides 1.5 +/- 0.7 mmol/L (132 +/- 64 mg/dL), and high-density lipoprotein cholesterol 1.6 +/- 0.5 mmol/L (64 +/- 18 mg/dL). LEADe will report in 2008 and is expected to provide a more definitive evaluation of the potential for statins in the

  4. CORONARY DIET INTERVENTION WITH OLIVE OIL AND CARDIOVASCULAR PREVENTION STUDY (THE CORDIOPREV STUDY): RATIONALE, METHODS, AND BASELINE CHARACTERISTICS

    PubMed Central

    Delgado-Lista, Javier; Perez-Martinez, Pablo; Garcia-Rios, Antonio; Alcala-Diaz, Juan F; Perez-Caballero, Ana I.; Gomez-Delgado, Francisco; Fuentes, Francisco; Quintana-Navarro, Gracia; Lopez-Segura, Fernando; Ortiz-Morales, Ana M; Delgado-Casado, Nieves; Yubero-Serrano, Elena; Camargo, Antonio; Marin, Carmen; Rodriguez-Cantalejo, Fernando; Gomez-Luna, Purificacion; Ordovas, Jose M; Lopez-Miranda, Jose; Perez-Jimenez, Francisco

    2016-01-01

    Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secondary prevention. The objective of the CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (CORDIOPREV study, clinical trials number NCT00924937) is to compare the ability of a Mediterranean diet rich in virgin olive oil versus a low-fat diet to influence the composite incidence of cardiovascular events after 7 years, in subjects with documented CHD at baseline. For this purpose, we enrolled 1002 coronary patients from Spain. Baseline assessment (2009–12) included detailed interviews and measurements to assess dietary, social and biological variables. Results of baseline characteristics: The CORDIOPREV study in Spain describes a population with a high BMI (37.2% overweight and 56.3% obesity), with a median of LDL-cholesterol of 88.5 mg/dL (70.6% of the patients having <100 mg/dL, and 20.3% patients < 70 mg/dL). 9.6% of the participants were active smokers, and 64.4% were former smokers. Metabolic Syndrome was present in 58% of this population. To sum up, we describe here the rationale, methods and baseline characteristics of the CORDIOPREV study, which will test for the first time the efficacy of a Mediterranean Diet rich in extra virgin olive oil as compared with a low-fat diet on the incidence of CHD recurrence in a long term follow-up study. PMID:27297848

  5. A Telephone Intervention for Dementia Caregivers: Background, Design, and Baseline Characteristics

    PubMed Central

    Tremont, Geoffrey; Davis, Jennifer; Papandonatos, George D.; Grover, Christine; Ott, Brian R.; Fortinsky, Richard H.; Gozalo, Pedro; Bishop, Duane S.

    2013-01-01

    Family caregivers of individuals with dementia are at heightened risk for emotional and mental health problems. Many caregivers do not seek assistance or become isolated in their caregiving role. Multi-component interventions have demonstrated efficacy for reducing emotional distress and burden, although these approaches are potentially costly and are not widely accessible. In response to these issues, we developed the Family Intervention: Telephone Tracking – Caregiver (FITT-C), which is an entirely telephone-based psychosocial intervention. The purpose of this paper is to describe the study design, methodology, and baseline data for the trial. This study uses a randomized controlled trial design to examine the efficacy of the FITT-C to reduce depressive symptoms and burden in distressed dementia caregivers. All participants (n = 250) received a packet of educational materials and were randomly assigned to receive 6 months of the FITT-C intervention or non-directive telephone support. The FITT-C intervention was designed to reduce distress in caregivers and is based on the McMaster Model of Family Functioning and the Lazarus, transition theory, and Folkman Stress and Coping Models. The primary dependent variables were depressive symptoms (Centers for Epidemiological Studies – Depression) and burden (Zarit Burden Interview, Revised Memory and Behavior Problems Checklist – Reaction). Secondary outcome measures included family functioning, self-efficacy, and health-related quality of life. Results of the study will provide important data about the efficacy of a telephone-based approach to reduce distress in dementia caregivers. PMID:23916916

  6. The Rush Memory and Aging Project: study design and baseline characteristics of the study cohort.

    PubMed

    Bennett, David A; Schneider, Julie A; Buchman, Aron S; Mendes de Leon, Carlos; Bienias, Julia L; Wilson, Robert S

    2005-01-01

    The long-term objective of the Rush Memory and Aging Project is to identify the postmortem indices linking genetic and environmental risk factors to the development of Alzheimer's disease (AD). The overall study design involves a detailed assessment of risk factors for AD in older persons without known dementia who agree to annual clinical evaluation and organ donation at the time of death. In contrast to other clinical-pathologic studies which are conducted on special populations, the Rush Memory and Aging Project enrolled a cohort with much greater diversity in terms of educational attainment, in addition to gender, race, and ethnicity. From September of 1997 through April of 2005, more than 1,000 older persons without known dementia from more than 30 residential facilities across the Chicago metropolitan area agreed to participate. Their mean age was 81 years, about a third had 12 or fewer years of education, a third were men, and about 10% were members of a racial or ethnic minority group. More than 950 already have completed their baseline clinical evaluation.

  7. A telephone intervention for dementia caregivers: background, design, and baseline characteristics.

    PubMed

    Tremont, Geoffrey; Davis, Jennifer; Papandonatos, George D; Grover, Christine; Ott, Brian R; Fortinsky, Richard H; Gozalo, Pedro; Bishop, Duane S

    2013-11-01

    Family caregivers of individuals with dementia are at heightened risk for emotional and mental health problems. Many caregivers do not seek assistance or become isolated in their caregiving role. Multi-component interventions have demonstrated efficacy for reducing emotional distress and burden, although these approaches are potentially costly and are not widely accessible. In response to these issues, we developed the Family Intervention: Telephone Tracking - Caregiver (FITT-C), which is an entirely telephone-based psychosocial intervention. The purpose of this paper is to describe the study design, methodology, and baseline data for the trial. This study uses a randomized controlled trial design to examine the efficacy of the FITT-C to reduce depressive symptoms and burden in distressed dementia caregivers. All participants (n=250) received a packet of educational materials and were randomly assigned to receive 6 months of the FITT-C intervention or non-directive telephone support. The FITT-C intervention was designed to reduce distress in caregivers and is based on the McMaster Model of Family Functioning, transition theory, and Lazarus and Folkman's Stress and Coping Models. The primary dependent variables were depressive symptoms (Centers for Epidemiological Studies - Depression) and burden (Zarit Burden Interview, Revised Memory and Behavior Problems Checklist - Reaction). Secondary outcome measures included family functioning, self-efficacy, and health-related quality of life. Results of the study will provide important data about the efficacy of a telephone-based approach to reduce distress in dementia caregivers. © 2013.

  8. Characteristics of Young Children with Obsessive-Compulsive Disorder: Baseline Features from the POTS Jr. Sample.

    PubMed

    Skriner, L C; Freeman, J; Garcia, A; Benito, K; Sapyta, J; Franklin, M

    2016-02-01

    Pediatric obsessive-compulsive disorder (OCD) is a chronic and impairing condition that can emerge early in childhood and persist into adulthood. The primary aim of this paper is to examine the characteristics of a large sample of young children with OCD (age range from 5 to 8). The sample will be described with regard to: demographics, OCD symptoms/severity, family history and parental psychopathology, comorbidity, and global and family functioning. The sample includes 127 youth with a primary diagnosis of OCD who participated in a multi-site, randomized control clinical trial of family-based exposure with response prevention. Key findings include moderate to severe OCD symptoms, high rates of impairment, and significant comorbidity, despite the participants' young age. Discussion focuses on how the characteristics of young children compare with older youth and with the few other samples of young children with OCD. Considerations regarding generalizability of the sample and limitations of the study are discussed.

  9. The personalized reminder information and social management system (PRISM) trial: rationale, methods and baseline characteristics.

    PubMed

    Czaja, Sara J; Boot, Walter R; Charness, Neil; A Rogers, Wendy; Sharit, Joseph; Fisk, Arthur D; Lee, Chin Chin; Nair, Sankaran N

    2015-01-01

    Technology holds promise in terms of providing support to older adults. To date, there have been limited robust systematic efforts to evaluate the psychosocial benefits of technology for older people and identify factors that influence both the usability and uptake of technology systems. In response to these issues, we developed the Personal Reminder Information and Social Management System (PRISM), a software application designed for older adults to support social connectivity, memory, knowledge about topics, leisure activities and access to resources. This trail is evaluating the impact of access to the PRISM system on outcomes such as social isolation, social support and connectivity. This paper reports on the approach used to design the PRISM system, study design, methodology and baseline data for the trial. The trial is multi-site randomized field trial. PRISM is being compared to a Binder condition where participants received a binder that contained content similar to that found on PRISM. The sample includes 300 older adults, aged 65-98 years, who lived alone and at risk for being isolated. The primary outcome measures for the trial include indices of social isolation and support and well-being. Secondary outcomes measures include indices of computer proficiency, technology uptake and attitudes towards technology. Follow-up assessments occurred at 6 and 12 months post-randomization. The results of this study will yield important information about the potential value of technology for older adults. The study also demonstrates how a user-centered iterative design approach can be incorporated into the design and evaluation of an intervention protocol.

  10. Relationship between volition, physical activity and weight loss maintenance: Study rationale, design, methods and baseline characteristics.

    PubMed

    Dandanell, Sune; Elbe, Anne-Marie; Pfister, Gertrud; Elsborg, Peter; W Helge, Jørn

    2017-05-01

    To investigate the relationship between volition, physical activity and weight loss maintenance. We recruited 84 sedentary (maximal oxygen uptake: 25 ± 5 ml/min), overweight and obese (Body mass index (BMI) 38 ± 7 m/h(2), fat 44 ± 7 %) women ( n = 55) and men ( n = 29) for an interdisciplinary prospective study with follow-up. The change in lifestyle and weight loss is promoted via a 3-month intensive lifestyle intervention at a private health school. The intervention consists of supervised training (1-3 hours/day), a healthy hypo-caloric diet (-500 to -700 kCal/day) and education in healthy lifestyle in classes/groups. The participants' body weight and composition (Dual Energy X-ray absorptiometry), volitional skills (questionnaire), physical activity level (heart rate accelerometer/questionnaire) and maximal oxygen uptake (indirect calorimetry) are to be monitored before, after, and 3 and 12 months after the intervention. At the 12-month follow-up, three different groups will be established: Clinical weight loss maintenance (> 10% weight loss from baseline), moderate weight loss maintenance (1-10% weight loss) and no weight loss (or weight regain). A linear mixed model analysis will be used to compare levels of volitional skills, physical activity and maximal oxygen uptake over time, between the three groups. Correlational analyses will be used to investigate possible associations between volition, maximal oxygen uptake, physical activity level and weight loss maintenance. If specific volitional skills are identified as predictors of adherence to physical activity and success in clinical weight loss maintenance, these can be trained in future intensive lifestyle interventions in order to optimize the success rate.

  11. Characteristics of turn signal use at intersections in baseline naturalistic driving.

    PubMed

    Sullivan, John M; Bao, Shan; Goudy, Roy; Konet, Heather

    2015-01-01

    The purpose of this study was to determine whether a driver's use of turn signals is sufficiently reliable to forecast a vehicle's future path around an intersection, when detailed information about the intersection is unavailable. Naturalistic observations of turn signal use among 108 drivers on surface streets were extracted from the baseline portion of a field operational test of a safety system. Left and right turns that resulted in heading changes of between 70 and 110° and turn radii between 18 and 90 m were selected from the dataset. The odds that a driver would signal a turn were modeled as a function of road type, turn direction, presence of a forward vehicle, whether the vehicle stopped before the turn, and driver age and gender. Overall, 25 percent of left turns and 29 percent of right turns were not signaled. Road type, turn direction, and presence of a forward vehicle were found to influence the odds that a turn is signaled, while gender and age of the driver did not. The results suggest that situational factors like road type and turn direction are more powerful predictors of whether a turn will be signaled than either age or gender. Signaling on major and minor surface roads was about 5 times more likely than on local roads and 1.5 times more likely when a forward vehicle was present, suggesting a possible effect of traffic volume. It was concluded that turn signal activation alone may be insufficiently reliable to forecast a driver's path. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. [Baseline clinical characteristics and management of patients included in IBERICAN study].

    PubMed

    Barrios, V; Escobar, C; Llisterri, J L; Rodríguez Roca, G; Badimón, J J; Vergara, J; Prieto, M Á; Serrano, A; Cinza, S; Murillo, C

    2015-01-01

    To determine the prevalence and incidence of cardiovascular risk factors and cardiovascular events in Spain, as well as the quality of the follow-up in clinical practice. In this study the baseline data of the first interim analysis of IBERICAN are shown (n=830). IBERICAN is a multicenter, longitudinal and observational population-based study of patients daily attended in primary care setting according to clinical practice in Spain. Subjects between 18 and 85 years daily attended in primary care setting are being included consecutively. Treatment of patients will be performed according only to clinical criteria of investigators. Blood pressure control was defined according to 2013 European guidelines of hypertension; LDL-cholesterol control was defined according to 2012 European guidelines of cardiovascular prevention; diabetes control was defined as HbA1c<7%. Mean age was 57.9±14.1 years. 54.1% of patients had dyslipidemia, 47.5% hypertension, 17.7% diabetes, and 10.8% history of ischemic heart disease. Regarding drugs, despite 55% of hypertensive patients were taking≥2 antihypertensive agents, only 59.9% achieved blood pressure targets; 65.7% of patients with dyslipidemia were taking statins, but only 35.6% attained LDL-cholesterol goals. Only 51.4% of diabetics achieved HbA1c goals. Subjects attended in primary care showed a high prevalence of cardiovascular risk factors with a poor control. Copyright © 2014 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España. All rights reserved.

  13. Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation (ASANTE) Trial: Design and Baseline Characteristics.

    PubMed

    Ervin, Ann-Margret; Mkocha, Harran; Munoz, Beatriz; Dreger, Kurt; Dize, Laura; Gaydos, Charlotte; Quinn, Thomas C; West, Sheila K

    2016-12-01

    Immigrants and travelers may be sources of re-emergent infection in trachoma-endemic communities close to trachoma elimination. The primary objective of the A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation (ASANTE) trial was to determine whether a newcomer and traveler surveillance and treatment program in addition to annual mass drug administration (MDA) would reduce Chlamydia trachomatis infection when compared to MDA alone. ASANTE was a randomized controlled trial in 52 communities in Kongwa, Tanzania. In 26 intervention communities, monitors treated everyone in new households, in-coming children and guardians in existing households, and all persons in households who had traveled between annual MDA events. A total of 26 usual practice communities received MDA only. Surveys of 100 1-9-year-olds from each community were conducted at baseline and every 6 months up to 2 years to assess clinical trachoma and C. trachomatis infection. Data on demographics and environmental factors were also collected. Mean prevalences of trachomatous inflammation - follicular (TF) and C. trachomatis were equivalent between the two arms (5.2% and 3.7% in intervention, and 4.9% and 3.6% in usual practice communities, respectively). Of 318 children with TF, 36.5% tested positive for C. trachomatis. TF prevalence was higher among households without a bicycle (p = 0.03) and lower with increasing child's age (p < 0.001). Infection prevalence was higher among households >30 minutes from water (p = 0.015). TF and infection prevalence decreased with increasing years of education (p = 0.004 and p = 0.002, respectively). The ASANTE trial will inform guidance on the surveillance and treatment of persons traveling or newly arriving to communities hypo-endemic for trachoma.

  14. The Personalized Reminder Information and Social Management System (PRISM) Trial: Rationale, Methods and Baseline Characteristics

    PubMed Central

    Czaja, Sara J.; Boot, Walter R.; Charness, Neil; Rogers, Wendy; Sharit, Joseph; Fisk, Arthur D.; Lee, Chin Chin; Nair, Sankaran N.

    2014-01-01

    Technology holds promise in terms of providing support to older adults. To date there have been limited robust systematic efforts to evaluate the psychosocial benefits of technology for older people and identify factors that influence both the usability and uptake of technology systems. In response to these issues we developed the Personal Reminder Information and Social Management System (PRISM), a software application designed for older adults to support social connectivity, memory, knowledge about topics, leisure activities and access to resources. This trail is evaluating the impact of access to the PRISM system on outcomes such as social isolation, social support and connectivity. This paper reports on the approach used to design the PRISM system, study design, methodology and baseline data for the trial. The trial is multi-site randomized field trial. PRISM is being compared to a Binder condition where participants received a binder that contained content similar to that found on PRISM. The sample includes 300 older adults, aged 65 – 98 years, who lived alone and at risk for being isolated. The primary outcome measures for the trial include indices of social isolation and support and well-being. Secondary outcomes measures include indices of computer proficiency, technology uptake and attitudes towards technology. Follow-up assessments occurred at 6 and 12 months post-randomization. The results of this study will yield important information about the potential value of technology for older adults. The study also demonstrates how a user-centered iterative design approach can be incorporated into the design and evaluation of an intervention protocol. PMID:25460342

  15. An investigation of the landing characteristics of the NASA-MSC August 1969 baseline orbiter configuration in ground effect

    NASA Technical Reports Server (NTRS)

    Chambliss, E. B.; Millikan, D.

    1972-01-01

    A 0.05 scale model of the NASA-MSC August 1969 baseline shuttle craft was tested in Texas A&M University's 7- x 10-foot low speed wind tunnel facility. The purpose of the test was to determine the landing aerodynamic characteristics of the shuttle craft vehicle in ground effect and to evaluate control surface hinge moments experienced in the cruise and landing operational phases of flight. Analysis of the final data will allow evaluation of vehicle flight stability in ground effect and estimation of vehicle control surface power system requirements.

  16. Baseline characteristics and treatment-emergent risk factors associated with cerebrovascular event and death with risperidone in dementia patients.

    PubMed

    Howard, Robert; Costafreda, Sergi G; Karcher, Keith; Coppola, Danielle; Berlin, Jesse A; Hough, David

    2016-11-01

    Use of antipsychotics to treat behavioural symptoms of dementia has been associated with increased risks of mortality and stroke. Little is known about individual patient characteristics that might be associated with bad or good outcomes. We examined the risperidone clinical trial data to look for individual patient characteristics associated with these adverse outcomes. Data from all double-blind randomised controlled trials of risperidone in dementia patients (risperidone n = 1009, placebo n = 712) were included. Associations between characteristics and outcome were analysed based on crude incidences and exposure-adjusted incidence rates, and by time-to-event analyses using Cox proportional hazards regression. Interactions between treatment (risperidone or placebo) and characteristic were analysed with a Cox proportional hazards regression model with main effects for treatment and characteristic in addition to the interaction term. Baseline complications of depression (treatment by risk factor interaction on cerebrovascular adverse event (CVAE) hazard ratio (HR): P = 0.025) and delusions (P = 0.043) were associated with a lower relative risk of CVAE in risperidone-treated patients (HR = 1.47 and 0.54, respectively) compared to not having the complication (HR = 5.88 and 4.16). For mortality, the only significant baseline predictor in patients treated with risperidone was depression, which was associated with a lower relative risk (P<0.001). The relative risk of mortality was increased in risperidone patients treated with anti-inflammatory medications (P = 0.021). Only anti-inflammatory medications increased mortality risk with risperidone. The reduced risks of CVAE in patients with comorbid depression and delusions, and of mortality with depression, may have clinical implications when weighing the benefits and risks of treatment with risperidone in patients with dementia. © The Royal College of Psychiatrists 2016.

  17. The Pregnancy in Polycystic Ovary Syndrome II study: baseline characteristics and effects of obesity from a multicenter randomized clinical trial.

    PubMed

    Legro, Richard S; Brzyski, Robert G; Diamond, Michael P; Coutifaris, Christos; Schlaff, William D; Alvero, Ruben; Casson, Peter; Christman, Gregory M; Huang, Hao; Yan, Qingshang; Haisenleder, Daniel J; Barnhart, Kurt T; Bates, G Wright; Usadi, Rebecca; Lucidi, Richard; Baker, Valerie; Trussell, J C; Krawetz, Stephen A; Snyder, Peter; Ohl, Dana; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping

    2014-01-01

    To summarize baseline characteristics from a large multicenter infertility clinical trial. Cross-sectional baseline data from a double-blind randomized trial of two treatment regimens (letrozole vs. clomiphene). Academic Health Centers throughout the United States. Seven hundred fifty women with polycystic ovary syndrome (PCOS) and their male partners took part in the study. None. Historic, biometric, biochemical, and questionnaire parameters. Females averaged 30 years and were obese (body mass index [BMI] 35) with ∼20% from a racial/ethnic minority. Most (87%) were hirsute and nulligravid (63%). Most of the women had an elevated antral follicle count and enlarged ovarian volume on ultrasound. Women had elevated mean circulating androgens, LH-to-FSH ratio (∼2), and antimüllerian hormone levels (8.0 ng/mL). In addition, women had evidence for metabolic dysfunction with elevated mean fasting insulin and dyslipidemia. Increasing obesity was associated with decreased LH-to-FSH levels, antimüllerian hormone levels, and antral follicle counts but increasing cardiovascular risk factors, including prevalence of the metabolic syndrome. Men were obese (BMI 30) and had normal mean semen parameters. The treatment groups were well matched at baseline. Obesity exacerbates select female reproductive and most metabolic parameters. We have also established a database and sample repository that will eventually be accessible to investigators. NCT00719186. Copyright © 2014 American Society for Reproductive Medicine. All rights reserved.

  18. The Correction of Myopia Evaluation Trial (COMET): design and general baseline characteristics.

    PubMed

    Hyman, L; Gwiazda, J; Marsh-Tootle, W L; Norton, T T; Hussein, M

    2001-10-01

    The Correction of Myopia Evaluation Trial (COMET) is a multicenter, randomized, double-masked, controlled clinical trial evaluating whether there is a difference in the progression of myopia between children wearing progressive addition lenses (PALs) versus conventional single vision lenses (SVLs), as measured by cycloplegic autorefraction. Axial length, measured by A-scan ultrasonography, is an additional outcome measure. To meet the recruitment goal of 450 participants, eligible children ages 6-11 years (inclusive) with myopia in both eyes (spherical equivalent between -1.25 diopters (D) and -4.50 D, astigmatism < or = 1.50 D, and anisometropia < 1.00 D) were recruited at four clinical centers between September 1997 and September 1998. Children who participated were assigned to receive PALs (Varilux Comfort with a +2.00 D addition) or SVLs. Measures include standardized cycloplegic autorefraction (Nidek ARK700A autorefractor), axial length (Sonomed A2500 ultrasound), subjective refraction (Marco TRS system), visual acuity (modified Early Treatment Diabetic Retinopathy Study protocol), accommodation (Canon R-1), and phoria (cover test and Maddox rod). Outcome measures are collected annually; adherence is assessed and prescriptions updated semiannually. Participants are being followed for at least 3 years. COMET enrolled 469 children. Their mean age is 9.3 years (range 6-11 years); 52% are female. COMET children are ethnically diverse, according to a self-report with 46% White, 26% African American, 14% Hispanic, and 8% Asian. Best-corrected visual acuity is better than 20/32 in both eyes. Baseline mean (+/-SD) cycloplegic refractive correction is -2.38 D (+/-0.81) in the right eye and -2.40 D (+/-0.82) in the left eye; mean (+/-SD) axial length is 24.1 mm (+/-0.7) in both eyes. Follow-up of these children will provide a first step in answering the important question of whether there are effective means to slow myopia progression. Study results should be applicable

  19. Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) study: baseline characteristics of enrolled subjects.

    PubMed

    Dagogo-Jack, Samuel; Edeoga, Chimaroke; Ebenibo, Sotonte; Chapp-Jumbo, Emmanuel

    2013-01-01

    The Pathobiology of Prediabetes in a Biracial Cohort (POP-ABC) study is a prospective evaluation of the natural history impaired glucose regulation. The eligibility requirements include age 18-65 yr, history of type 2 diabetes in one or both parents, normal fasting plasma glucose (FPG) or normal glucose tolerance, and African-American or Caucasian status. Participants underwent assessments (including dietary and exercise behavior, clinical examination, glucose tolerance, insulin sensitivity, β-cell function, body composition, energy expenditure) during 2.25-5.5 yr of quarterly follow-up. The primary outcome is the occurrence of prediabetes. Baseline data are presented for the 376 enrolled participants. The cohort was also compared with National Health and Nutrition Examination Survey 2007/2008 participants meeting the age and glycemic criteria for the POP-ABC study. The POP-ABC cohort [mean (±SD) age was 44.2 ± 10.6 yr] was 57.7% African-Americans, 42.3% Caucasians, and 70.7% females; 86% had one parent with diabetes and 14% had both parents affected. Although greater than 70% of the cohort were employed and 75% had more than 13 yr of education, more African-Americans reported incomes less than $20,000 and fewer reported incomes more than $75,000 compared with Caucasians. Compared with Caucasians, African-Americans had a higher body mass index (31.3 ± 7.8 vs. 28.8 ± 7.8 kg/m(2), P = 0.001), a lower FPG (90.0 ± 7.72 vs. 92.2 ± 7.60 mg/dl, P = 0.008), higher glycosylated hemoglobin, lower triglycerides, and similar blood pressure, and homeostasis model assessment of insulin resistance, homeostasis model assessment of β-cell function, high-density lipoprotein, and low-density lipoprotein cholesterol levels. Compared with a cross-section of U.S. subjects (National Health and Nutrition Examination Survey 2007/2008) with normal FPG and normal glucose tolerance, participants in the POP-ABC study had similar lipid profile but were more educated and had higher body

  20. The Harbin Cohort Study on Diet, Nutrition and Chronic Non-Communicable Diseases: Study Design and Baseline Characteristics

    PubMed Central

    Feng, Rennan; Li, Jie; Han, Tianshu; Lin, Liqun; Lan, Li; Yang, Chao; Li, Ying; Sun, Changhao

    2015-01-01

    Diet and nutrition have been reported to be associated with many common chronic diseases and blood-based assessment would be vital to investigate the association and mechanism, however, blood-based prospective studies are limited. The Harbin Cohort Study on Diet, Nutrition and Chronic Non-communicable Diseases was set up in 2010. From 2010 to 2012, 9,734 participants completed the baseline survey, including demographic characteristics, dietary intake, lifestyles and physical condition, and anthropometrics. A re-survey on 490 randomly selected participants was done by using the same methods which were employed in the baseline survey. For all participants, the mean age was 50 years and 36% of them were men. Approximately 99.4 % of cohort members donated blood samples. The mean total energy intake was 2671.7 kcal/day in men and 2245.9 kcal/day in women, the mean body mass index was 25.7 kg/m2 in men and 24.6 kg/m2 in women, with 18.4% being obese (≥28 kg/m2), 12.7% being diabetic, and 29.5% being hypertensive. A good agreement was obtained for the physical measurements between the baseline survey and re-survey. The resources from the cohort and its fasting and postprandial blood samples collected both at baseline and in each follow-up will be valuable and powerful in investigating relationship between diet, nutrition and chronic diseases and discovering novel blood biomarkers and the metabolism of these biomarkers related to chronic diseases. PMID:25856294

  1. Comparison of baseline characteristics and one-year outcomes between African-Americans and Caucasians undergoing percutaneous coronary intervention.

    PubMed

    Leborgne, Laurent; Cheneau, Edouard; Wolfram, Roswitha; Pinnow, Ellen E; Canos, Daniel A; Pichard, Augusto D; Suddath, William O; Satler, Lowell F; Lindsay, Joseph; Waksman, Ron

    2004-02-15

    The objectives of this study were to determine whether there are race-based differences in baseline characteristics and in short- or long-term outcomes after percutaneous coronary intervention (PCI). African-Americans have a higher incidence of coronary artery disease but are less likely to undergo coronary revascularization than Caucasians. Little is known about the profiles and outcomes of African-Americans who undergo PCI. Consecutive series of 1,268 African-Americans and 10,561 Caucasians with symptomatic coronary artery disease who underwent PCI between January 1994 and June 2001 were analyzed. Patients hospitalized for acute myocardial infarction were excluded. African-Americans were older, were more likely to be women, and had more co-morbid baseline conditions compared with Caucasians. Preprocedure lesion characteristics were similar with regard to vessel size, length, and complexity. The rate of clinical success did not differ between the groups. African-Americans experienced more in-hospital combined events of death and Q-wave myocardial infarction (p = 0.03). After propensity score adjustment, African-American race was not an independent predictor for in-hospital events. At 1 year, African-Americans had a slightly lower rate of target lesion revascularization and a 50% higher rate of death (9.8% vs. 6.4%, p <0.001), with a relative risk of 1.52 (95% confidence interval 1.22 to 1.89). In multivariate analysis, African-American race remained a significant predictor of increased 1-year mortality (hazard ratio 1.35, 95% confidence interval 1.06 to 1.71, p = 0.01). African-Americans undergoing angioplasty have more co-morbid baseline conditions than Caucasians. Despite similar clinical success, 1-year outcomes are impaired in African-Americans.

  2. Influence of feeding a fish oil-containing diet to young, lean, adult dogs: effects on lipid metabolites, postprandial glycaemia and body weight.

    PubMed

    de Godoy, Maria R C; Conway, Charlotte E; Mcleod, Kyle R; Harmon, David L

    2015-01-01

    The aim of this study was to determine the effect of feeding a fish oil (FO)-containing diet on lipid and protein metabolism, postprandial glycaemia and body weight in young, lean, adult dogs. Eight female Beagles were randomly assigned to one of two isonitrogenous and isoenergetic diets, Control or FO, in a crossover design. At the beginning of the experiment and at 30 and 60 d, a baseline blood sample was collected and the dogs then were fed their daily ration. Nitrogen balance began at 07:00 h on day 63 of each experimental period and ended at 07:00 h on day 69. On day 66 of each period, a single dose (7.5 mg/kg) of (15)N-glycine was administered orally to each dog via gelatin capsule. Postprandial glycaemia did not differ between treatments or among sampling days within treatment. Cholesterol concentration was increased (p<0.05) on the Control treatment throughout the experiment when compared to values of day 0. Dogs fed the FO treatment had higher plasma triglyceride and ghrelin concentrations than those fed the Control treatment. Body weight and food intake did not differ between dietary treatments. Faecal excretion was increased (p<0.05) in the FO treatment. Dry matter digestibility was decreased (p<0.05) and fat digestibility tended (p<0.10) to decrease in the FO treatment. Overall, feeding a FO-containing diet showed a protective effect against the rise of plasma cholesterol and it increased plasma ghrelin concentration. However, FO supplementation did not appear to affect protein metabolism or postprandial glycaemia in adult lean dogs.

  3. Living with diabetes: rationale, study design and baseline characteristics for an Australian prospective cohort study

    PubMed Central

    2012-01-01

    Background Diabetes mellitus is a major global public health threat. In Australia, as elsewhere, it is responsible for a sizeable portion of the overall burden of disease, and significant costs. The psychological and social impact of diabetes on individuals with the disease can be severe, and if not adequately addressed, can lead to the worsening of the overall disease picture. The Living With Diabetes Study aims to contribute to a holistic understanding of the psychological and social aspects of diabetes mellitus. Methods/Design The Living With Diabetes Study is a 5-year prospective cohort study, based in Queensland, Australia. The first wave of data, which was collected via a mailed self-report survey, was gathered in 2008, with annual collections thereafter. Measurements include: demographic, lifestyle, health and disease characteristics; quality of life (EQ-5D, ADDQoL); emotional well-being (CES-D, LOT-R, ESSI); disease self-management (PAM); and health-care utilisation and patient-assessed quality of care (PACIC). 29% of the 14,439 adults who were invited to participate in the study agreed to do so, yielding a sample size of 3,951 people. Discussion The data collected by the Living With Diabetes Study provides a good representation of Australians with diabetes to follow over time in order to better understand the natural course of the illness. The study has potential to further illuminate, and give a comprehensive picture of the psychosocial implications of living with diabetes. Data collection is ongoing. PMID:22216947

  4. Genetic study of diabetic retinopathy: recruitment methodology and analysis of baseline characteristics.

    PubMed

    Kaidonis, Georgia; Abhary, Sotoodeh; Daniell, Mark; Gillies, Mark; Fogarty, Rhys; Petrovsky, Nikolai; Jenkins, Alicia; Essex, Rohan; Chang, John H; Pal, Bishwanath; Hewitt, Alex W; Burdon, Kathryn P; Craig, Jamie E

    2014-07-01

    Diabetic retinopathy (DR) is a blinding disease of increasing prevalence that is caused by a complex interplay of genetic and environmental factors. Here we describe the patient recruitment methodology, case and control definitions, and clinical characteristics of a study sample to be used for genome-wide association analysis to detect genetic risk variants of DR. One thousand six hundred sixty-nine participants with either type 1 (T1) or type 2 (T2) diabetes mellitus (DM) aged 18 to 95 years were recruited in Australian hospital clinics. Individuals with T2DM had disease duration of at least 5 years and were taking oral hypoglycaemic medication, and/or insulin therapy. Participants underwent ophthalmic examination. Medical history and biochemistry results were collected. Venous blood was obtained for genetic analysis. Six hundred eighty-three diabetic cases (178 T1DM and 505 T2DM participants) with sight-threatening DR, defined as severe non-proliferative DR, proliferative DR or diabetic macular oedema were included in this analysis. Eight hundred twelve individuals with DM but no DR or minimal non-proliferative DR were recruited as controls (191 with T1DM and 621 with T2DM). The presence of sight-threatening DR was significantly correlated with DM duration, hypertension, nephropathy, neuropathy, HbA1C and body mass index. Diabetic macular oedema was associated with T2DM (P < 0.001), whereas proliferative DR was associated with T1DM (P < 0.001). Adoption of a case-control study design involving extremes of the DR phenotype makes this a suitable cohort, for a well-powered genome-wide association study to detect genetic risk variants for DR. © 2013 Royal Australian and New Zealand College of Ophthalmologists.

  5. Patients Enrolled in HIV Care in Mozambique: Baseline Characteristics and Follow-Up Outcomes

    PubMed Central

    Lahuerta, Maria; Lima, Josue; Elul, Batya; Okamura, Mie; Alvim, Maria Fernanda; Nuwagaba-Biribonwoha, Harriet; Horowitz, Deborah; Fernandes, Rufino; Assan, Americo; Abrams, Elaine J.; El-Sadr, Wafaa M.; Nash, Denis

    2012-01-01

    Objective To utilize routinely collected service delivery data from HIV care and treatment clinics in Mozambique to describe the patient population and programmatic outcomes from 2003 to 2009. Methods Data from patient charts were entered into an electronic database at 28 clinics in 5 Mozambican provinces. Patients’ characteristics at enrollment in HIV care and at antiretroviral therapy (ART) initiation were examined. We calculated a corrected 12-month mortality estimate using a recently developed nomogram for sub-Saharan African ART patients. Results A total of 154,188 HIV-infected individuals (10,164 children <15 years old) were enrolled in HIV care services between 2003 and 2009. Of the 51,269 (36%) adults who started ART, 35% initiated ART with CD4 count <100 cells per microliter and 14.4% with World Health Organization stage IV. Just more than 10% (10.5%) of women were documented to be pregnant at enrollment. One-third of the 3,745 (37%) children who initiated ART were <2 years old, and 53%of those <5 years initiated ART severely immunosuppressed (CD4% <15%). Thirty-five percent of all children and 30% of those initiating ART met the definition of severe malnourishment (weight-for-age Z score <−3). Among those who initiated ART, the median estimated 12-month mortality rate across sites was 13.1% (interquartile range: 11.5%–16.0%) and 13.5% (interquartile range: 11.4%–17.4%) for adults and children, respectively. Conclusions A substantial number of HIV-infected patients have been enrolled in HIV care and initiated on ART, with many patients having advanced HIV disease. With the release of new guidelines for ART use for adults, pregnant women, and children, extensive efforts are needed to ensure more timely initiation of ART. PMID:21725246

  6. Comparative effects of Stevia rebaudiana leaves and stevioside on glycaemia and hepatic gluconeogenesis.

    PubMed

    Ferreira, Edilene Bega; de Assis Rocha Neves, Francisco; da Costa, Marlom Anselmo; do Prado, Wilson Alves; de Araújo Funari Ferri, Letícia; Bazotte, Roberto Barbosa

    2006-06-01

    The purpose of the present study was to compare the effect of the oral treatment (gavage) with Stevia rebaudiana (Bert.) Bertoni (SRB) and stevioside (STV) on glycaemia and gluconeogenesis of 15-h fasted rats. For this purpose, the rats received SRB (20 mg/kg x day), STV (5.5 mg/kg x day) or an equal volume of water (controls) during 15 days. To measure hepatic gluconeogenesis, liver perfusion and isolated hepatocytes were used. Glycaemia and gluconeogenesis from L-alanine (5 mM), L-glutamine (5 mM) and L-lactate (2 mM) were decreased (P < 0.05) after pre-treatment with SRB. However, the treatment with STV did not influence glycaemia and gluconeogenesis. Moreover, to get further information about the mechanism by which SRB leaves inhibit gluconeogenesis their potential role as a PPARgamma agonist was investigated. The data showed absence of activation of PPARgamma receptors. In summary, our results showed that the reduction of glycaemia promoted by the treatment with SRB leaves was mediated, at least in part, by an inhibition of hepatic gluconeogenesis. However, this effect did not involve stevioside and the activation of PPARgamma receptors.

  7. The United Kingdom Glaucoma Treatment Study: a multicenter, randomized, double-masked, placebo-controlled trial: baseline characteristics.

    PubMed

    Lascaratos, Gerassimos; Garway-Heath, David F; Burton, Robyn; Bunce, Catey; Xing, Wen; Crabb, David P; Russell, Richard A; Shah, Ameet

    2013-12-01

    -controlled trial to evaluate the efficacy of medical treatment in reducing VF deterioration in OAG. The baseline characteristics for eligible patients and eyes from this cohort are presented and compared with those of previous trials. The baseline characteristics are similar to those of the largely population-based Early Manifest Glaucoma Trial. The early stage of the glaucoma and relatively low IOP at diagnosis suggest remarkably sensitive case findings by community optometrists in the United Kingdom. Copyright © 2013 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  8. EVEREST study report 2: imaging and grading protocol, and baseline characteristics of a randomised controlled trial of polypoidal choroidal vasculopathy.

    PubMed

    Tan, Colin S; Ngo, Wei Kiong; Chen, Jian Ping; Tan, Nikolle W; Lim, Tock Han

    2015-05-01

    To describe the imaging standards, grading protocol and baseline characteristics of polypoidal choroidal vasculopathy (PCV) from the EVEREST study. In a prospective, multicentre study, confocal scanning laser ophthalmoscope indocyanine green angiography (ICGA) was performed using a standardised imaging protocol. All images were graded using standardised, calibrated equipment by fellowship-trained ophthalmologists at the Central Reading Center. Sixty-one patients with PCV were included in the study. ICGA characteristics included: nodular appearance stereoscopically (56 eyes, 91.8%), hypofluorescent halo (42, 68.9%), abnormal vascular network (54, 88.5%) and pulsation of the polyps (4, 6.6%). Colour fundus photography revealed orange subretinal nodules (34, 55.7%) and massive submacular haemorrhage (8, 13.1%). The mean area of the PCV lesion was 3.11 mm(2) (range, 0.2-10.7 mm(2)). The vascular channels filled within 7.3-32.0 s (mean: 17.9 s) while the mean filling time for polyps was 21.9 s (range, 7.3-40.4 s). Patients with massive submacular haemorrhage were less likely to have abnormal vascular channels seen on ICGA (28.6% vs 83.3% for those without massive haemorrhage, p=0.001). The imaging and grading protocols and baseline characteristics of a multicentre, randomised controlled trial of PCV are described in detail, and may serve as reference for future randomised, controlled trials on PCV. This work was supported by Novartis Pharma AG, Basel, Switzerland grant number NCT00674323 (clinicaltrials.gov). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  9. Baseline characteristics of an incident haemodialysis population in Spain: results from ANSWER--a multicentre, prospective, observational cohort study.

    PubMed

    Pérez-García, Rafael; Martín-Malo, Alejandro; Fort, Joan; Cuevas, Xavier; Lladós, Fina; Lozano, Javier; García, Fernando

    2009-02-01

    The ANSWER study aims to identify risk factors leading to increased cardiovascular morbidity and mortality in a Spanish incident haemodialysis population. This paper summarizes the baseline characteristics of this population. A prospective, observational, one-cohort study, including all consecutive incident haemodialysis patients from 147 Spanish nephrology services, was conducted. Patients were enrolled between October 2003 and September 2004. Sociodemographic, clinical, laboratory and health care characteristics were collected. Baseline characteristics are described for 2341 incident haemodialysis patients [mean (SD) age 65.2 (14.5) years, 63% males]. The main cause of renal failure was diabetic nephropathy (26%). The majority of patients (57%) had a Karnofsky score of 80-100 and 27% were followed up by a nephrologist for 500 ng/ml, 41% and saturated transferrin <20 or >40%, 50%) despite previous treatment with erythropoiesis-stimulating agents in 41% of cases. There is excessive use of temporary catheters and a high prevalence of uraemia-related cardiovascular risk factors among incident haemodialysis patients in Spain. The poor control of hypertension, anaemia, malnutrition and mineral metabolism and late referral to a nephrologist indicate the need for improving the

  10. Salivary glucose in monitoring glycaemia in patients with type 1 diabetes mellitus: a systematic review.

    PubMed

    Naing, Cho; Mak, Joon Wah

    2017-01-01

    Incidence of type 1 diabetes mellitus is increasing worldwide. Monitoring glycaemia is essential for control of diabetes mellitus. Conventional blood-based measurement of glucose requires venepuncture or needle prick, which is not free from pain and risk of infection. The non-invasiveness, ease and low-cost in collection made saliva an attractive alternative sample. The objective of this review was to systematically review the evidence on the relationship between salivary glucose level and blood glucose level in monitoring glycaemia in patients with type 1 diabetes mellitus. We searched studies which evaluate salivary glucose levels and serum glycaemia in type 1 diabetes mellitus in electronic databases of MEDLINE, EMBASE, Ovid and Google Scholar. We selected the eligible studies, following the inclusion criteria set for this review. Due to heterogeneity of studies, we conducted qualitative synthesis of studies. Ten observational studies were included in this review, including a total of 321 cases and 323 controls with ages between 3 and 61 years and the majority were males (62%). Two studies were done exclusively on children below 17 years old. The significant difference between salivary glucose levels in type 1 diabetes mellitus and controls were reported in 6 studies with 8 data sets. Five studies with 7 datasets reported the correlation coefficient between salivary glucose and blood glucose in patients with diabetes. Findings suggest that salivary glucose concentrations may be helpful in monitoring glycaemia in type 1 diabetes mellitus. However, the utility of using salivary glucose level to monitor glycaemia should be evaluated in future well designed, prospective studies with adequate number of participants with type 1 diabetes mellitus.

  11. Open-Label Randomized Trial of Titrated Disease Management for Patients with Hypertension: Study Design and Baseline Sample Characteristics

    PubMed Central

    Jackson, George L.; Weinberger, Morris; Kirshner, Miriam A.; Stechuchak, Karen M.; Melnyk, Stephanie D.; Bosworth, Hayden B.; Coffman, Cynthia J.; Neelon, Brian; Van Houtven, Courtney; Gentry, Pamela W.; Morris, Isis J.; Rose, Cynthia M.; Taylor, Jennifer P.; May, Carrie L.; Han, Byungjoo; Wainwright, Christi; Alkon, Aviel; Powell, Lesa; Edelman, David

    2016-01-01

    Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12 months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5 years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy. PMID:27417982

  12. Baseline characteristics and effects of ten years of growth hormone (GH) replacement therapy in adults previously treated with pituitary irradiation.

    PubMed

    Elbornsson, Mariam; Götherström, Galina; Bengtsson, Bengt-Åke; Johannsson, Gudmundur; Svensson, Johan

    2013-12-01

    Little is known of the importance of previous irradiation therapy for baseline characteristics and responsiveness to GH replacement in GH deficient (GHD) adults. In this prospective, single-centre, open-label study, the effects of 10-year GH replacement were determined in 18 GHD adults that had previously received conventional external fractionated pituitary irradiation therapy (IRR group) and 18 non-irradiated GHD patients (non-IRR group). All patients had adult onset disease and complete deficiency of anterior pituitary hormones and both groups were comparable in terms of age, gender, body mass index (BMI), and waist:hip ratio. At baseline, IRR patients had higher serum triglyceride (TG) and insulin levels and lower high density lipoprotein (HDL)-cholesterol (HDL-C) level than non-IRR patients (all p<0.05). The 10-year GH replacement improved body composition, bone mass and serum lipid profile without any between-group differences, except for a marginally more beneficial response in serum TG level in the IRR patients. After 10 years, there was no between-group difference in any variable after correction for a higher replacement dose of glucocorticoids in the IRR patients at study end using an analysis of covariance. During the 10-year GH replacement, 5 IRR patients suffered from vascular events (2 fatal) whereas only one non-fatal vascular event occurred in the non-IRR patients. IRR patients with GHD display a more severely impaired cardiovascular risk profile at baseline, which was reversed by the 10-year GH replacement after correction for the higher glucocorticoid dose at study end. However, vascular events occurred more frequently in the IRR patients. © 2013.

  13. Influence of baseline demographic and clinical characteristics in the visual outcome of intermediate uveitis: a survival analysis.

    PubMed

    Abásolo, Lydia; Prieto-García, Ángela; Díaz-Valle, David; Benítez-Del-Castillo, José Manuel; Pato, Esperanza; García-Feijoo, Julián; Fernández-Gutiérrez, Benjamín; Rodriguez-Rodriguez, Luis

    2016-12-01

    To describe in patients diagnosed with intermediate uveitis (IU) the incidence rate (IR) of visual loss and newly diagnosed clinical complications during follow-up. Also, to analyse the influence of baseline complications on visual loss. Longitudinal retrospective cohort study which included 97 affected eyes of 67 consecutive patients diagnosed with IU according to the Standardization of Uveitis Nomenclature group, first seen in our clinic between 1986 and 2014, and until loss to follow-up, or 1 January 2015. Kaplan-Meier curves were set to account for temporary and permanent visual loss and development of clinical complications during follow-up. Cox's bivariate and multivariate regression models were constructed to examine the risk factors for visual loss. IRs (in events per 100 eyes-year) for the development of cystic macular oedema (CMO), epiretinal membrane (ERM) and cataracts were 5.9 (3.70-9.4), 1.2 (0.50-2.6) and 6.6 (4.4-10.1), respectively. IRs per 100 eyes-year of temporary moderate and severe visual loss episodes were 43.8 (37.3-51.4) and 6.4 (4.5-9.0), respectively. IR of permanent moderate visual loss was 5.3 (3.3-8.3). After 2 years of follow-up, 21% of eyes had developed a permanent moderate visual loss. Presence at baseline of lower visual acuity was associated with higher IR of temporary visual loss episodes, and CMO was associated with higher IR of temporary moderate visual loss. IU seems to have a favourable long-term prognosis. Permanent visual loss occurs during the first year of the disease. Baseline characteristics could identify patients with a higher risk of poor visual prognosis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  14. Mixed states with predominant manic or depressive symptoms: baseline characteristics and 24-month outcomes of the EMBLEM cohort.

    PubMed

    Azorin, Jean-Michel; Baraille, Laurent; Gérard, Stéphanie; Bertsch, Jordan; Reed, Catherine; Lukasiewicz, Michael

    2013-04-25

    While factors associated with mixed states have been extensively studied, data are scant regarding the clinical heterogeneity of mixed states. The EMBLEM study was a prospective, observational study on patients with manic and mixed states. We describe and compare baseline characteristics and 24-month clinical course of mixed states with predominant depressive symptoms (MSDS) and mixed states with predominant manic symptoms (MSMS). Adult inpatients/outpatients with bipolar disorder were enrolled within the standard course of care if they initiated or changed oral medication for acute mania or mixed states. A logistic regression was used to identify the baseline factors associated with each polarity. Comparisons with mixed episode without symptom predominance (OMS) were performed for informational purpose only. About 573 mixed patients were analyzed (23.7% of the cohort): 59.5% (n=341) had MSMS, 11.9% (n=68) had MSDS, and 28.6% (n=164) had OMS. At baseline, hallucinations/delusions during the index episode, inpatient status, high CGI-BP overall score, and low education level were more often associated with MSMS versus MSDS. Alcohol abuse or dependence and selective serotonin reuptake inhibitor (SSRI) or benzodiazepine use at inclusion were significantly more frequent with MSDS. MSDS had a significantly lower 24-month recurrence rate than MSMS; MSMS experienced more switches to mania whereas MSDS switched more to depression. The post hoc dimensional definitions in the study require caution in the interpretation of the results. These results present evidence of clinical heterogeneity within mixed states. Predominant manic or depressive symptoms within mixed episode could influence clinicians' decisions in term of hospitalization, treatment, and perception of bipolar severity. Copyright © 2012 Elsevier B.V. All rights reserved.

  15. Open-label randomized trial of titrated disease management for patients with hypertension: Study design and baseline sample characteristics.

    PubMed

    Jackson, George L; Weinberger, Morris; Kirshner, Miriam A; Stechuchak, Karen M; Melnyk, Stephanie D; Bosworth, Hayden B; Coffman, Cynthia J; Neelon, Brian; Van Houtven, Courtney; Gentry, Pamela W; Morris, Isis J; Rose, Cynthia M; Taylor, Jennifer P; May, Carrie L; Han, Byungjoo; Wainwright, Christi; Alkon, Aviel; Powell, Lesa; Edelman, David

    2016-09-01

    Despite the availability of efficacious treatments, only half of patients with hypertension achieve adequate blood pressure (BP) control. This paper describes the protocol and baseline subject characteristics of a 2-arm, 18-month randomized clinical trial of titrated disease management (TDM) for patients with pharmaceutically-treated hypertension for whom systolic blood pressure (SBP) is not controlled (≥140mmHg for non-diabetic or ≥130mmHg for diabetic patients). The trial is being conducted among patients of four clinic locations associated with a Veterans Affairs Medical Center. An intervention arm has a TDM strategy in which patients' hypertension control at baseline, 6, and 12months determines the resource intensity of disease management. Intensity levels include: a low-intensity strategy utilizing a licensed practical nurse to provide bi-monthly, non-tailored behavioral support calls to patients whose SBP comes under control; medium-intensity strategy utilizing a registered nurse to provide monthly tailored behavioral support telephone calls plus home BP monitoring; and high-intensity strategy utilizing a pharmacist to provide monthly tailored behavioral support telephone calls, home BP monitoring, and pharmacist-directed medication management. Control arm patients receive the low-intensity strategy regardless of BP control. The primary outcome is SBP. There are 385 randomized (192 intervention; 193 control) veterans that are predominately older (mean age 63.5years) men (92.5%). 61.8% are African American, and the mean baseline SBP for all subjects is 143.6mmHg. This trial will determine if a disease management program that is titrated by matching the intensity of resources to patients' BP control leads to superior outcomes compared to a low-intensity management strategy. Published by Elsevier Inc.

  16. ALS Multicenter Cohort Study of Oxidative Stress (ALS COSMOS): study methodology, recruitment, and baseline demographic and disease characteristics.

    PubMed

    Mitsumoto, Hiroshi; Factor-Litvak, Pam; Andrews, Howard; Goetz, Raymond R; Andrews, Leslie; Rabkin, Judith G; McElhiney, Martin; Nieves, Jeri; Santella, Regina M; Murphy, Jennifer; Hupf, Jonathan; Singleton, Jess; Merle, David; Kilty, Mary; Heitzman, Daragh; Bedlack, Richard S; Miller, Robert G; Katz, Jonathan S; Forshew, Dallas; Barohn, Richard J; Sorenson, Eric J; Oskarsson, Bjorn; Fernandes Filho, J Americo M; Kasarskis, Edward J; Lomen-Hoerth, Catherine; Mozaffar, Tahseen; Rollins, Yvonne D; Nations, Sharon P; Swenson, Andrea J; Shefner, Jeremy M; Andrews, Jinsy A; Koczon-Jaremko, Boguslawa A

    2014-06-01

    Abstract In a multicenter study of newly diagnosed ALS patients without a reported family history of ALS, we are prospectively investigating whether markers of oxidative stress (OS) are associated with disease progression. Methods utilize an extensive structured telephone interview ascertaining environmental, lifestyle, dietary and psychological risk factors associated with OS. Detailed assessments were performed at baseline and at 3-6 month intervals during the ensuing 30 months. Our biorepository includes DNA, plasma, urine, and skin. Three hundred and fifty-five patients were recruited. Subjects were enrolled over a 36-month period at 16 sites. To meet the target number of subjects, the recruitment period was prolonged and additional sites were included. Results showed that demographic and disease characteristics were similar between 477 eligible/non-enrolled and enrolled patients, the only difference being type of health insurance among enrolled patients. Sites were divided into three groups by the number of enrolled subjects. Comparing these three groups, the Columbia site had fewer 'definite ALS' diagnoses. This is the first prospective, interdisciplinary, in-depth, multicenter epidemiological investigation of OS related to ALS progression and has been accomplished by an aggressive recruitment process. The baseline demographic and disease features of the study sample are now fully characterized.

  17. ALS Multicenter Cohort Study of Oxidative Stress (ALS COSMOS): The study methodology, recruitment, and baseline demographic and disease characteristics

    PubMed Central

    Mitsumoto, Hiroshi; Factor-Litvak, Pam; Andrews, Howard; Goetz, Raymond R.; Andrews, Leslie; Rabkin, Judith G.; McElhiney, Martin; Nieves, Jeri; Santella, Regina M.; Murphy, Jennifer; Hupf, Jonathan; Singleton, Jess; Merle, David; Kilty, Mary; Heitzman, Daragh; Bedlack, Richard S.; Miller, Robert G; Katz, Jonathan S.; Forshew, Dallas; Barohn, Richard J.; Sorenson, Eric J.; Oskarsson, Bjorn; Filho, J Americo M. Fernandes; Kasarskis, Edward J.; Lomen-Hoerth, Catherine; Mozaffar, Tahseen; Rollins, Yvonne D.; Nations, Sharon P.; Swenson, Andrea J.; Shefner, Jeremy M.; Andrews, Jinsy A.; Koczon-Jaremko, Boguslawa A.

    2015-01-01

    Objective In a multicenter study of newly diagnosed ALS patients without a reported family history of ALS, we are prospectively investigating whether markers of oxidative stress (OS) are associated with disease progression. Methods An extensive structured telephone interview ascertained environmental, lifestyle, dietary and psychological risk factors associated with OS. Detailed assessments were performed at baseline and at 3 to 6 month intervals during the ensuing 30 months. Our biorepository includes DNA, plasma, urine, and skin. Results 355 patients were recruited. Subjects were enrolled over a 36 month-period at 16 sites. To meet the target number of subjects, the recruitment period was prolonged and additional sites were included. Demographic and disease characteristics were similar between 477 eligible/non-enrolled and enrolled patients, with the only difference being type of health insurance among enrolled patients. Sites were divided into 3 groups by the number of enrolled subjects. Comparing these 3 groups, the Columbia site had fewer “definite ALS” diagnoses. Conclusion This is the first prospective, interdisciplinary, in-depth, multicenter epidemiological investigation of OS related to ALS progression and was accomplished by an aggressive recruitment process. The baseline demographic and disease features of the study sample are now fully characterized. PMID:24564738

  18. The Ontario Uterine Fibroid Embolization Trial. Part 1. Baseline patient characteristics, fibroid burden, and impact on life.

    PubMed

    Pron, Gaylene; Cohen, Marsha; Soucie, Jennifer; Garvin, Greg; Vanderburgh, Leslie; Bell, Stuart

    2003-01-01

    To determine baseline characteristics of women undergoing uterine artery embolization (UAE) for symptomatic fibroids. Multicenter, prospective, single-arm clinical treatment trial. Eight Ontario university and community hospitals. Five hundred fifty-five women undergoing UAE for fibroids. Baseline questionnaires completed before UAE. Questionnaires were analyzed for demographic, medical, and gynecologic histories. Fibroid symptoms, impact of symptoms, previous consultations, and treatments were also analyzed. The Ontario cohort (66% white, 23% black, 11% other races) had an average age of 43. Thirty-one percent were under age 40. Most women were university educated (68%) and working outside the home (85%). Women reported heavy menstrual bleeding (80%), urinary urgency/frequency (73%), pain during intercourse (41%), and work absences (40%). They experienced fibroid-related symptoms for an average of 5 years and consulted with on average of three gynecologists before UAE. High fibroid life-impact scores were reported by 58%. Black women were significantly younger (40.7 vs. 44.0 years), more likely to experience symptoms longer (7 vs. 5 years), and more likely to undergo myomectomy before UAE (24% vs. 9%) than white women. Our study illustrates that large numbers of women with highly symptomatic fibroid disease are averse to surgery despite their burden of suffering and are actively seeking alternatives to hysterectomy.

  19. Associations of trunk fat depots with insulin resistance, β cell function and glycaemia--a multiple technique study.

    PubMed

    Ganpule-Rao, Anjali; Joglekar, Charudatta; Patkar, Deepak; Chinchwadkar, Manoj; Bhat, Dattatreya; Lubree, Himangi; Rege, Sonali; Uradey, Bhagyashree; Yajnik, Chittaranjan; Yudkin, John

    2013-01-01

    Central (truncal) adiposity is associated strongly with insulin resistance and diabetes. There are very few reports comparing methods of trunk fat measurement in their ability to predict glycaemia and insulin resistance. We report a comparative analysis of different trunk fat measurements in predicting glycaemia and insulin resistance in middle aged Indian men. Trunk fat measurements were performed using anthropometry, magnetic resonance imaging (MRI), dual-energy X-ray absorptiometry (DXA) and computed tomography (CT) on 128 men. Additional measurements were taken to characterise insulin resistance (Matsuda index) and beta cell function (Insulinogenic Index), glycaemia (fasting and 120 min glucose concentrations). Using residual approach we compared the ability of different trunk fat measurement techniques to predict insulin resistance, beta cell function and glycaemia. There was a strong association between trunk fat measures from each technique with glycaemia and insulin resistance indices but not with the Insulinogenic Index. Insulin resistance and glycaemia, were best predicted using anthropometric measurements, notably by waist circumference and subscapular skinfold thickness. Neither MRI measures of trunk or visceral fat nor DXA trunk fat added significantly. CT liver density contributed to some extent to predict insulin resistance and 120 min glucose after anthropometric measurements. Our results suggest that, in Indian men, anthropometric measurements are good predictors of glycaemia and insulin resistance. Other complex measurements such as MRI, DXA and CT make only a small addition to the prediction. This finding supports the application of anthropometry for determining trunk fat in clinical and epidemiological settings.

  20. Baseline Patient Characteristics Predicting Outcome and Attrition in Cognitive Therapy for Social Phobia: Results from a Large Multicentre Trial.

    PubMed

    Hoyer, Juergen; Wiltink, Joerg; Hiller, Wolfgang; Miller, Robert; Salzer, Simone; Sarnowsky, Stephan; Stangier, Ulrich; Strauss, Bernhard; Willutzki, Ulrike; Leibing, Eric

    2016-01-01

    We examined the role of baseline patient characteristics as predictors of outcome (end-state functioning, response and remission) and attrition for cognitive therapy (CT) in social anxiety disorder (SAD). Beyond socio-demographic and clinical variables such as symptom severity and comorbidity status, previously neglected patient characteristics (e.g., personality, self-esteem, shame, interpersonal problems and attachment style) were analysed. Data came from the CT arm of a multicentre RCT with n = 244 patients having DSM-IV SAD. CT was conducted according to the manual by Clark and Wells. Severity of SAD was assessed at baseline and end of treatment with the Liebowitz Social Anxiety Scale (LSAS). Multiple linear regression analyses and logistic regression analyses were applied. Up to 37% of the post-treatment variance (LSAS) could be explained by all pre-treatment variables combined. Symptom severity (baseline LSAS) was consistently negatively associated with end-state functioning and remission, but not with response. Number of comorbid diagnoses was negatively associated with end-state functioning and response, but not with remission. Self-esteem was positively associated with higher end-state functioning and more shame with better response. Attrition could not be significantly predicted. The results indicate that the initial probability for treatment success mainly depends on severity of disorder and comorbid conditions while other psychological variables are of minor importance, at least on a nomothetic level. This stands in contrast with efforts to arrive at an empirical-based foundation for differential indication and argues to search for more potent moderators of therapeutic change rather on the process level. Personality, self-esteem, shame, attachment style and interpersonal problems do not or only marginally moderate the effects of interventions in CT of social phobia. Symptom severity and comorbid diagnoses might affect treatment outcome negatively

  1. Baseline Demographic and Clinical Characteristics of Patients with Adrenal Incidentaloma from a Single Center in China: A Survey

    PubMed Central

    Yang, Guoqing; Zhao, Ling; Gu, Weijun; Lv, Zhaohui; Lu, Juming; Mu, Yiming

    2017-01-01

    Aim To investigate the clinical and endocrinological characteristics of patients with adrenal incidentaloma (AI). Materials and Methods This retrospective study enrolled 1941 AI patients hospitalized at the Department of Endocrinology, Chinese PLA General Hospital, Beijing, China, between January 1997 and December 2016. The patient gender, age at visits, imaging features, functional status, and histological results were analyzed. Results Of the 1941 patients, 984 (50.70%) were men. The median age was 52 years (interquartile range: 44–69 years). 140 cases had bilateral AI. Endocrine evaluation showed that 1411 (72.69%) patients had nonfunctional tumor, 152 (7.83%) had subclinical Cushing syndrome (SCS), and 82 (4.33%) had primary hyperaldosteronism. A total of 925 patients underwent operation for removal of 496 cortical adenomas (53.62%), 15 adrenal cortical carcinomas (1.62%), and 172 pheochromocytomas (18.59%). The bilateral group had a higher proportion of SCS (18.57% versus 7.10%, P < 0.001, P = 0.006). A mass size of 46 mm was of great value in distinguishing malignant tumors from the benign tumors, with sensitivity of 88.2% and specificity of 95.5%. Conclusions We reported the baseline demographic and clinical characteristics of patients with AI in a large series from a single center in China. PMID:28848603

  2. Common mental disorders and sociodemographic characteristics: baseline findings of the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil).

    PubMed

    Nunes, Maria A; Pinheiro, Andréa P; Bessel, Marina; Brunoni, André R; Kemp, Andrew H; Benseñor, Isabela M; Chor, Dora; Barreto, Sandhi; Schmidt, Maria I

    2016-01-01

    To assess the prevalence of common mental disorders (CMD) and the association of CMD with sociodemographic characteristics in the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) cohort. We analyzed data from the cross-sectional baseline assessment of the ELSA-Brasil, a cohort study of 15,105 civil servants from six Brazilian cities. The Clinical Interview Schedule-Revised (CIS-R) was used to investigate the presence of CMD, with a score ≥ 12 indicating a current CMD (last week). Specific diagnostic algorithms for each disorder were based on the ICD-10 diagnostic criteria. Prevalence ratios (PR) of the association between CMD and sociodemographic characteristics were estimated by Poisson regression. CMD (CIS-R score ≥ 12) was found in 26.8% (95% confidence intervals [95%CI] 26.1-27.5). The highest burden occurred among women (PR 1.9; 95%CI 1.8-2.0), the youngest (PR 1.7; 95%CI 1.5-1.9), non-white individuals, and those without a university degree. The most frequent diagnostic category was anxiety disorders (16.2%), followed by depressive episodes (4.2%). The burden of CMD was high, particularly among the more socially vulnerable groups. These findings highlight the need to strengthen public policies aimed to address health inequities related to mental disorders.

  3. Baseline characteristics of an incident haemodialysis population in Spain: results from ANSWER—a multicentre, prospective, observational cohort study

    PubMed Central

    Pérez-García, Rafael; Martín-Malo, Alejandro; Fort, Joan; Cuevas, Xavier; Lladós, Fina; Lozano, Javier; García, Fernando

    2009-01-01

    Background. The ANSWER study aims to identify risk factors leading to increased cardiovascular morbidity and mortality in a Spanish incident haemodialysis population. This paper summarizes the baseline characteristics of this population. Methods. A prospective, observational, one-cohort study, including all consecutive incident haemodialysis patients from 147 Spanish nephrology services, was conducted. Patients were enrolled between October 2003 and September 2004. Sociodemographic, clinical, laboratory and health care characteristics were collected. Results. Baseline characteristics are described for 2341 incident haemodialysis patients [mean (SD) age 65.2 (14.5) years, 63% males]. The main cause of renal failure was diabetic nephropathy (26%). The majority of patients (57%) had a Karnofsky score of 80–100 and 27% were followed up by a nephrologist for ≤6 months. In total, 86% of the patients had hypertension, 43% had dyslipidaemia and 44% had a history of cardiovascular disease. Initial vascular access was obtained via a temporary catheter in 30% of patients, via a permanent catheter in 16% and via an arteriovenous fistula in 54%. Albumin levels were <3.5 g/dl in 43% of patients. Immediately prior to the onset of haemodialysis, the mean (SD) glomerular filtration rate (GFR) was 7.6 (2.8) ml/min/1.73 m2, and only 6.7% of the patients were within the K/DOQI guidelines for all four bone mineral markers. In addition, a high proportion of patients had anaemia markers outside the EBPG guidelines (haemoglobin <11 g/dl, 59%, ferritin <100 or >500 ng/ml, 41% and saturated transferrin <20 or >40%, 50%) despite previous treatment with erythropoiesis-stimulating agents in 41% of cases. Conclusions. There is excessive use of temporary catheters and a high prevalence of uraemia-related cardiovascular risk factors among incident haemodialysis patients in Spain. The poor control of hypertension, anaemia, malnutrition and mineral metabolism and late referral to a nephrologist

  4. The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1).

    PubMed

    Chew, Emily Y; Clemons, Traci; SanGiovanni, John Paul; Danis, Ronald; Domalpally, Amitha; McBee, Wendy; Sperduto, Robert; Ferris, Frederick L

    2012-11-01

    The Age-Related Eye Disease Study (AREDS) demonstrated beneficial effects of oral supplementation with antioxidant vitamins and minerals on the development of advanced age-related macular degeneration (AMD) in persons with at least intermediate AMD (bilateral large drusen with or without pigment changes). Observational data suggest that other oral nutrient supplements might further reduce the risk of progression to advanced AMD. The primary purpose of the Age-Related Eye Disease Study 2 (AREDS2) is to evaluate the efficacy and safety of lutein plus zeaxanthin (L+Z) and/or ω-3 long-chain polyunsaturated fatty acid (LCPUFA) supplementation in reducing the risk of developing advanced AMD. The study also assesses the reduction in zinc and the omission of β-carotene from original AREDS formulation. Multicenter, phase III, randomized, controlled clinical trial. Persons aged 50 to 85 with bilateral intermediate AMD or advanced AMD in 1 eye. All participants were randomly assigned to placebo (n = 1012), L+Z (10 mg/2 mg; n = 1044), ω-3 LCPUFAs (eicosapentaenoic acid + docosahexaenoic acid [650 mg/350 mg]; n = 1069), or the combination of L+Z and ω-3 LCPUFAs (n = 1078). All participants were offered a secondary randomization to 1 of 4 variations of the original AREDS formulation keeping vitamins C (500 mg) and E (400 IU) and copper (2 mg) unchanged while varying zinc and β-carotene as follows: Zinc remains at the original level (80 mg), lower only zinc to 25 mg, omit β-carotene only, or lower zinc to 25 mg and omit β-carotene. Progression to advanced AMD determined by centralized grading of annual fundus photographs. We enrolled 4203 participants at 82 clinical centers located in the United States. Population characteristics at baseline were as follows: Mean age, 74 years; 57% female; 97% white; 7% current smokers; 19% with prior cardiovascular disease; and 44% and 50% taking statin-class cholesterol-lowering drugs and aspirin, respectively. Ocular characteristics

  5. Baseline Characteristics of Patients with Diabetes and Coronary Artery Disease Enrolled in the BARI 2D Trial

    PubMed Central

    Brooks, Maria Mori; Barsness, Gregory; Chaitman, Bernard; Chung, Sheng-Chia; Faxon, David; Feit, Frederick; Frye, Robert; Genuth, Saul; Green, Jennifer; Hlatky, Mark; Kelsey, Sheryl; Kennedy, Frank; Krone, Ronald; Nesto, Richard; Orchard, Trevor; O'Rourke, Robert; Rihal, Charanjit; Tardif, Jean-Claude

    2009-01-01

    Background The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) was undertaken to determine whether early revascularization intervention is superior to deferred intervention in the presence of aggressive medical therapy and whether antidiabetes regimens targeting insulin sensitivity are more or less effective than regimens targeting insulin provision in reducing cardiovascular events among patients with type 2 diabetes mellitus and stable coronary artery disease (CAD). Methods BARI 2D is an NIH-sponsored randomized clinical trial with a 2×2 factorial design. Between 2001 and 2005, 49 clinical sites in North America, South America and Europe randomized 2,368 patients. At baseline, the trial collected data on clinical history, symptoms and medications along with centralized evaluations of angiograms, electrocardiograms, and blood and urine specimens. Results The majority of BARI 2D patients were referred from the cardiac catheterization laboratory (54%) or cardiology clinic (27%). Of the randomized participants, 30% were women, 34% were minorities, 61% had angina, and 67% had multi-region CAD. Moreover, 29% had been treated with insulin, 58% had HbA1c > 7.0%, 41% LDL cholesterol ≥ 100 mg/dl, 52% blood pressure > 130/80 mmHg, and 56% BMI ≥ 30 kg/m2. Conclusions Baseline characteristics in BARI 2D are well-balanced between the randomized treatment groups, and the clinical profile of the study cohort is representative of the target population. As a result, the BARI 2D clinical trial is in an excellent position to evaluate alternative treatment approaches for diabetes and CAD. PMID:18760137

  6. Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL).

    PubMed

    Bassuk, Shari S; Manson, JoAnn E; Lee, I-Min; Cook, Nancy R; Christen, William G; Bubes, Vadim Y; Gordon, David S; Copeland, Trisha; Friedenberg, Georgina; D'Agostino, Denise M; Ridge, Claire Y; MacFadyen, Jean G; Kalan, Kate; Buring, Julie E

    2016-03-01

    Evidence for a role of supplemental vitamin D and marine omega-3 fatty acids in preventing cancer and cardiovascular disease (CVD) remains inconclusive and insufficient to inform nutritional recommendations for primary prevention. The VITamin D and Omega-A 3 TriaL (VITAL) is an ongoing nationwide, randomized, double-blind, placebo-controlled clinical trial designed to fill this knowledge gap. The study population consists of 25,874 U.S. adults without cancer or CVD at baseline, who were selected only on age (men aged ≥50 and women aged ≥55), with an oversampling of African Americans (n=5,107). In a 2 × 2 factorial design, participants were randomized to one of four supplement groups: [1] active vitamin D3 (cholecalciferol; 2000 IU/d) and active marine omega-3 fatty acids (Omacor® fish oil, eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA], 1g/d); [2] active vitamin D and omega-3 placebo; [3] vitamin D placebo and active marine omega-3 fatty acids; or [4] vitamin D placebo and omega-3 placebo. The mean length of the randomized treatment period will be 5 years. The randomization was successful, as evidenced by similar distributions of baseline demographic, health, and behavioral characteristics across treatment groups. The similar distribution of known potential confounders across treatment groups strongly suggests that unmeasured or unknown potential confounders are also equally distributed. VITAL is expected to provide important information on the benefit-risk balance of vitamin D and omega-3 fatty acid supplementation when taken for the primary prevention of cancer and CVD.

  7. The Family Spirit trial for American Indian teen mothers and their children: CBPR rationale, design, methods and baseline characteristics.

    PubMed

    Mullany, Britta; Barlow, Allison; Neault, Nicole; Billy, Trudy; Jones, Tanya; Tortice, Iralene; Lorenzo, Sherilynn; Powers, Julia; Lake, Kristin; Reid, Raymond; Walkup, John

    2012-10-01

    The purpose of this paper is to describe the rationale, design, methods and baseline results of the Family Spirit trial. The goal of the trial is to evaluate the impact of the paraprofessional-delivered "Family Spirit" home-visiting intervention to reduce health and behavioral risks for American Indian teen mothers and their children. A community based participatory research (CBPR) process shaped the design of the current randomized controlled trial of the Family Spirit intervention. Between 2006 and 2008, 322 pregnant teens were randomized to receive the Family Spirit intervention plus Optimized Standard Care, or Optimized Standard Care alone. The Family Spirit intervention is a 43-session home-visiting curriculum administered by American Indian paraprofessionals to teen mothers from 28 weeks gestation until the baby's third birthday. A mixed methods assessment administered at nine intervals measures intervention impact on parental competence, mother's and children's social, emotional and behavioral risks for drug use, and maladaptive functioning. Participants are young (mean age = 18.1 years), predominantly primiparous, unmarried, and challenged by poverty, residential instability and low educational attainment. Lifetime and pregnancy drug use were ~2-4 times higher and ~5-6 times higher, respectively, than US All Races. Baseline characteristics were evenly distributed between groups, except for higher lifetime cigarette use and depressive symptoms among intervention mothers. If study aims are achieved, the public health field will have new evidence supporting multi-generational prevention of behavioral health disparities affecting young American Indian families and the utility of indigenous paraprofessional interventionists in under-resourced communities.

  8. Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL)

    PubMed Central

    Bassuk, Shari S.; Manson, JoAnn E.; Lee, I-Min; Cook, Nancy R.; Christen, William G.; Bubes, Vadim Y.; Gordon, David S.; Copeland, Trisha; Friedenberg, Georgina; D’Agostino, Denise M.; Ridge, Claire Y.; MacFadyen, Jean G.; Kalan, Kate; Buring, Julie E.

    2016-01-01

    Evidence for a role of supplemental vitamin D and marine omega-3 fatty acids in preventing cancer and cardiovascular disease (CVD) remains inconclusive and insufficient to inform nutritional recommendations for primary prevention. The VITamin D and Omega-A 3 TriaL (VITAL) is an ongoing nationwide, randomized, double-blind, placebo-controlled clinical trial designed to fill this knowledge gap. The study population consists of 25,874 U.S. adults without cancer or CVD at baseline, who were selected only on age (men aged ≥50 and women aged ≥55), with an oversampling of African Americans (n=5,107). In a 2x2 factorial design, participants were randomized to one of four supplement groups: (1) active vitamin D3 (cholecalciferol; 2000 IU/d) and active marine omega-3 fatty acids (Omacor® fish oil, eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA], 1 g/d); (2) active vitamin D and omega-3 placebo; (3) vitamin D placebo and active marine omega-3 fatty acids; or (4) vitamin D placebo and omega-3 placebo. The mean length of the randomized treatment period will be 5 years. The randomization was successful, as evidenced by similar distributions of baseline demographic, health, and behavioral characteristics across treatment groups. The similar distribution of known potential confounders across treatment groups strongly suggests that unmeasured or unknown potential confounders are also equally distributed. VITAL is expected to provide important information on the benefit-risk balance of vitamin D and omega-3 fatty acid supplementation when taken for the primary prevention of cancer and CVD. PMID:26767629

  9. The laser in glaucoma and ocular hypertension (LiGHT) trial. A multicentre randomised controlled trial: baseline patient characteristics.

    PubMed

    Konstantakopoulou, Evgenia; Gazzard, Gus; Vickerstaff, Victoria; Jiang, Yuzhen; Nathwani, Neil; Hunter, Rachael; Ambler, Gareth; Bunce, Catey

    2017-10-05

    The laser in glaucoma and ocular hypertension (LiGHT) trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open angle glaucoma (POAG) or ocular hypertension (OHT). LiGHT is a prospective unmasked, multicentre, pragmatic, randomised controlled trial (RCT). 718 previously untreated patients with POAG or OHT were recruited at 6 UK centres between 2012 and 2014. Patients were randomised to initial SLT followed by medical therapy or medical therapy without laser. Participants will be monitored for 3 years, according to routine clinical practice. The primary outcome is EQ-5D-5L. Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index (GUI), Glaucoma Symptom Scale, Glaucoma Quality of Life (GQL), pathway effectiveness, visual function, safety and concordance. A total of 555 patients had POAG and 163 OHT; 518 patients had both eyes eligible. The mean age for patients with POAG was 64 years and for OHT 58 years. 70% of all participants were white. Median IOP for OHT eyes was 26 mm Hg and 23 mm Hg for POAG eyes. Median baseline visual field mean deviation was -0.81 dB for OHT eyes and -2.82 dB for POAG eyes. There was no difference between patients with POAG and patients with OHT on the EQ-5D-5DL; the difference between OHT and POAG on the GUI was -0.02 and 1.23 on the GQL. The LiGHT trial is the first RCT to compare the two treatment options in a real-world setting. The baseline characteristics of the LiGHT cohort compare well with other landmark glaucoma studies. ISRCTN32038223, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  10. Baseline characteristics and factors associated with nutritional and pulmonary status at enrollment in the cystic fibrosis EPIC observational cohort.

    PubMed

    Rosenfeld, Margaret; Emerson, Julia; McNamara, Sharon; Joubran, Kelli; Retsch-Bogart, George; Graff, Gavin R; Gutierrez, Hector H; Kanga, Jamshed F; Lahiri, Thomas; Noyes, Blake; Ramsey, Bonnie; Ren, Clement L; Schechter, Michael; Morgan, Wayne; Gibson, Ronald L

    2010-09-01

    The EPIC Observational Study is an ongoing prospective cohort study investigating risk factors for and clinical outcomes associated with early Pseudomonas aeruginosa (Pa) acquisition in young children with cystic fibrosis (CF). To describe the baseline characteristics of the cohort and evaluate associations between potential risk factors and nutritional and respiratory characteristics at enrollment. We hypothesized that distinct demographic and environmental risk factors could be identified for poorer nutritional status and lung function at enrollment. During 2004-2006, 1,700 children with CF were enrolled at 59 US CF centers. Children characteristics associated with nutritional and pulmonary status at enrollment included diagnosis after prenatal or neonatal screening (protective) and in utero cigarette exposure (harmful). (c) 2010 Wiley

  11. Baseline participant characteristics and risk for dropout from ten obesity randomized controlled trials: a pooled analysis of individual level data.

    PubMed

    Kaiser, Kathryn A; Affuso, Olivia; Desmond, Renee; Allison, David B

    Understanding participant demographic characteristics that inform the optimal design of obesity RCTs have been examined in few studies. The objective of this study was to investigate the association of individual participant characteristics and dropout rates (DORs) in obesity randomized controlled trials (RCT) by pooling data from several publicly available datasets for analyses. We comprehensively characterize DORs and patterns in obesity RCTs at the individual study level, and describe how such rates and patterns vary as a function of individual-level characteristics. We obtained and analyzed nine publicly-available, obesity RCT datasets that examined weight loss or weight gain prevention as a primary or secondary endpoint. Four risk factors for dropout were examined by Cox proportional hazards including sex, age, baseline BMI, and race/ethnicity. The individual study data were pooled in the final analyses with a random effect for study, and HR and 95% CIs were computed. Results of the multivariate analysis indicated that the risk of dropout was significantly higher for females compared to males (HR= 1.24, 95% CI = 1.05, 1.46). Hispanics and Non-Hispanic blacks had a significantly higher dropout rate compared to non-Hispanic whites (HR= 1.62, 95% CI = 1.37, 1.91; HR= 1.22, 95% CI = 1.11, 1.35, respectively). There was a significantly increased risk of dropout associated with advancing age (HR= 1.02, 95% CI = 1.01, 1.02) and increasing BMI (HR= 1.03, 95% CI = 1.03, 1.04). As more studies may focus on special populations, researchers designing obesity RCTs may wish to oversample in certain demographic groups if attempting to match comparison groups based on generalized estimates of expected dropout rates, or otherwise adjust a priori power estimates. Understanding true reasons for dropout may require additional methods of data gathering not generally employed in obesity RCTs, e.g. time on treatment.

  12. Baseline characteristics, analysis plan and report on feasibility for the Prevention Of Decline in Cognition After Stroke Trial (PODCAST).

    PubMed

    Scutt, Polly; Blackburn, Dan; Krishnan, Kailash; Ballard, Clive; Burns, Alistair; Ford, Gary A; Mant, Jonathan; Passmore, Peter; Pocock, Stuart; Reckless, John; Sprigg, Nikola; Stewart, Rob; Wardlaw, Joanna M; Bath, Philip M

    2015-11-07

    A common complication after stroke is development of cognitive impairment and dementia. However, effective strategies for reducing the risk of developing these problems remain undefined. Potential strategies include intensive lowering of blood pressure (BP) and/or lipids. This paper summarises the baseline characteristics, statistical analysis plan and feasibility of a randomised control trial of blood pressure and lipid lowering in patients post-stroke with the primary objective of reducing cognitive impairment and dementia. The Prevention Of Decline in Cognition After Stroke Trial (PODCAST) was a multi-centre prospective randomised open-label blinded-endpoint controlled partial-factorial internal pilot trial running in secondary and primary care. Participants without dementia were enrolled 3-7 months post ischaemic stroke or spontaneous intracerebral haemorrhage, and randomised to intensive versus guideline BP lowering (target systolic BP <125 mmHg versus <140 mmHg); patients with ischaemic stroke were also randomised to intensive or guideline lipid lowering (target LDL cholesterol <1.4 mmol/L versus <3 mmol/L). The primary outcome was the Addenbrooke's Cognitive Examination-Revised; a key secondary outcome was to assess feasibility of performing a large trial of one or both interventions. Data are number (%) or mean (standard deviation). The trial was planned to last for 8 years with follow-up between 1 and 8 years. The plan for reporting the main results is included as Additional file 2. 83 patients (of a planned 600) were recruited from 19 UK sites between 7 October 2010 and 31 January 2014. Delays, due to difficulties in the provision of excess treatment costs and to complexity of follow-up, led to few centres taking part and a much lower recruitment rate than planned. Patient characteristics at baseline were: age 74 (SD 7) years, male 64 (77 %), index stroke ischaemic 77 (93 %), stroke onset to randomisation 4.5 [SD 1.3] months, Addenbrooke's Cognitive

  13. Impact of polyvascular disease on baseline characteristics, management and mortality in acute myocardial infarction. The Alliance project.

    PubMed

    Meizels, Anouk; Zeitoun, David Messika; Bataille, Vincent; Cambou, Jean-Pierre; Collet, Jean-Philippe; Cottin, Yves; Dujardin, Jean-Jacques; Goldstein, Patrick; Danchin, Nicolas; Thomas, Daniel; Steg, Phillipe Gabriel

    2010-04-01

    A substantial number of patients with acute myocardial infarction (AMI) have polyvascular disease (PolyVD), defined as cerebrovascular disease (CVD), peripheral arterial disease (PAD) or both. To investigate the impact of PolyVD on baseline characteristics, management and outcomes. The Alliance project is a multicentre, cross-sectional database of patients with myocardial infarction throughout France from 2000 to 2005. A pooled analysis of individual patient data was performed by aggregating data from five registries, representing 9783 patients hospitalized for acute coronary syndromes. Data were collected on history of PAD and CVD and correlated to baseline characteristics, management and hospital outcomes. Eight thousand nine hundred and four patients had full datasets for this analysis (13% with a history of CVD or PAD, 87% without). Patients with PolyVD were older (72 vs 65 years, p<0.0001), had a more frequent history of AMI (26% vs 15%, p<0.0001), percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), renal insufficiency (12% vs 3%, p<0.0001) and consistently more risk factors for atherosclerosis (hypertension, dyslipidaemia, smoking, diabetes), but less frequently a body mass index>30 kg/m(2) (14.0% vs 20.1%, p<0.0001) compared to patients with coronary artery disease (CAD) alone. Killip class, left-ventricular ejection fraction and GUSTO risk score were all worse among patients with PolyVD. Management of patients with PolyVD was less aggressive (with later admission and less frequent use of in-hospital angiography or evidence-based therapies at discharge). Mortality of patients with PolyVD was consistently higher than in those with CAD alone, regardless of age. Multivariable analysis, adjusting for age, showed that both PAD (odds ratio 1.36 95% confidence interval 1.03-1.79) and history of CVD (odds ratio 1.74, 95% confidence interval 1.27-2.40) were independent predictors of hospital mortality relative to patients with CAD only

  14. Effect of the oyster fungus on glycaemia and cholesterolaemia in rats with insulin-dependent diabetes.

    PubMed

    Chorváthová, V; Bobek, P; Ginter, E; Klvanová, J

    1993-01-01

    We have investigated the effect of a diet containing of 4% oyster fungus (Pleurotus ostreatus) and 0.1% cholesterol on glycaemia and hyperlipoproteinaemia in rats with insulin-dependent diabetes (streptozotocin 45 mg/kg). After two months, the rats with diabetes kept on the oyster fungus diet, had a significantly lower basal and postprandial glycaemia, the insulinaemia remained unchanged. The cholesterol concentration was decreased by more than 40%, the lipoprotein profile was upgraded by the decrease of the cholesterol in both the low density and very low density lipoproteins. The oyster fungus decreased the cholesterol accumulation in the liver and had no significant effects on the levels of serum and liver triacylglycerols.

  15. Meeting the WHO 90% target: antiretroviral treatment efficacy in Poland is associated with baseline clinical patient characteristics

    PubMed Central

    Parczewski, Milosz; Siwak, Ewa; Leszczyszyn-Pynka, Magdalena; Cielniak, Iwona; Burkacka, Ewa; Pulik, Piotr; Witor, Adam; Muller, Karolina; Zasik, Ewelina; Grzeszczuk, Anna; Jankowska, Maria; Lemańska, Małgorzata; Olczak, Anita; Grąbczewska, Edyta; Szymczak, Aleksandra; Gąsiorowski, Jacek; Szetela, Bartosz; Bociąga-Jasik, Monika; Skwara, Paweł; Witak-Jędra, Magdalena; Jabłonowska, Elżbieta; Wójcik-Cichy, Kamila; Kamerys, Juliusz; Janczarek, Małgorzata; Krankowska, Dagny; Mikuła, Tomasz; Kozieł, Katarzyna; Bielec, Dariusz; Stempkowska, Justyna; Kocbach, Aleksandra; Błudzin, Wiesława; Horban, Andrzej

    2017-01-01

    :1.47 (95%CI:1.08–2.01), p = 0.016], baseline lymphocyte CD4 count ≥200 cells/µL [OR:1.72 (95%CI:1.04–2.78), p = 0.034] and negative HCV serology [OR:1.97 (95%CI:1.29–2.94), p = 0.002]. For viral load threshold <200 copies/mL higher likelihood of virologic success was only associated with baseline lymphocyte CD4 count ≥200 cells/µL [OR:2.08 (95%CI:1.01–4.35), p = 0.049] and negative HCV status [OR:2.84 (95%CI:1.52–5.26), p = 0.001]. Conclusions: Proportion of virologically suppressed patients is in line with WHO treatment target confirming successful application of antiretroviral treatment strategy in Poland. Virological suppression rates depend on baseline patient characteristics, which should guide individualized antiretroviral tre0atment decisions. PMID:28715160

  16. Farmers' Cohort for Agricultural Work-Related Musculoskeletal Disorders (FARM) Study: Study Design, Methods, and Baseline Characteristics of Enrolled Subjects.

    PubMed

    Jo, Hannae; Baek, Sora; Park, Hee-Won; Lee, Sang-Ah; Moon, Jiyoung; Yang, Jae E; Kim, Ki Sung; Kim, Jee Yong; Kang, Eun Kyoung

    2016-01-01

    The ongoing Farmers' Cohort for Agricultural Work-related Musculoskeletal Disorders (FARM) study was developed to evaluate health status and related factors in farmers. Farmers in Kangwon Province, South Korea, were recruited. Baseline characteristics were determined using questionnaires about sociodemographic and health characteristics and agricultural work-related factors. In addition, laboratory examinations (lumbar spinal radiography and serologic testing) were conducted. The FARM study covers eight rural areas and recruited 1013 subjects (534 women; mean [standard deviation {SD}] age, 57.2 [7.5] years). Musculoskeletal pain in multiple areas was reported by 925 subjects (91.3%), and low back pain (63.8%) was the most frequent site of pain. Farmer's Stress Inventory (mean [SD], 77.7 [10.2]; range, 28-112] and subjective stress index (mean [SD], 5.3 [2.4]; range, 0-10) were above median scale values, reflecting a stressful condition, while the EuroQol-5D-3L index and the EuroQol-Visual Analog Scale scores were high (mean [SD], 0.9 [0.1]; range -0.171-1 and mean [SD], 67.7 [18.7]; range 0-100, respectively), reflecting good life quality. In total, 53% of participants had worked in farming for more than 30 years, and workers involved in dry-field farming comprised the largest subgroup (41.5%). Most participants (94.3%) had no more than a high school education, and families with annual income below 20 million won constituted the largest subgroup (36.3%). The FARM study may provide data on the current health status and related sociodemographic and agricultural work-related risk factors in Korean farmers, with the goal of providing a scientific basis for developing coping interventions and preventive strategies.

  17. Farmers’ Cohort for Agricultural Work-Related Musculoskeletal Disorders (FARM) Study: Study Design, Methods, and Baseline Characteristics of Enrolled Subjects

    PubMed Central

    Jo, Hannae; Baek, Sora; Park, Hee-won; Lee, Sang-Ah; Moon, Jiyoung; Yang, Jae E.; Kim, Ki Sung; Kim, Jee Yong; Kang, Eun Kyoung

    2016-01-01

    Background The ongoing Farmers’ Cohort for Agricultural Work-related Musculoskeletal Disorders (FARM) study was developed to evaluate health status and related factors in farmers. Methods Farmers in Kangwon Province, South Korea, were recruited. Baseline characteristics were determined using questionnaires about sociodemographic and health characteristics and agricultural work-related factors. In addition, laboratory examinations (lumbar spinal radiography and serologic testing) were conducted. Results The FARM study covers eight rural areas and recruited 1013 subjects (534 women; mean [standard deviation {SD}] age, 57.2 [7.5] years). Musculoskeletal pain in multiple areas was reported by 925 subjects (91.3%), and low back pain (63.8%) was the most frequent site of pain. Farmer’s Stress Inventory (mean [SD], 77.7 [10.2]; range, 28–112] and subjective stress index (mean [SD], 5.3 [2.4]; range, 0–10) were above median scale values, reflecting a stressful condition, while the EuroQol-5D-3L index and the EuroQol-Visual Analog Scale scores were high (mean [SD], 0.9 [0.1]; range −0.171–1 and mean [SD], 67.7 [18.7]; range 0–100, respectively), reflecting good life quality. In total, 53% of participants had worked in farming for more than 30 years, and workers involved in dry-field farming comprised the largest subgroup (41.5%). Most participants (94.3%) had no more than a high school education, and families with annual income below 20 million won constituted the largest subgroup (36.3%). Conclusions The FARM study may provide data on the current health status and related sociodemographic and agricultural work-related risk factors in Korean farmers, with the goal of providing a scientific basis for developing coping interventions and preventive strategies. PMID:26235456

  18. Baseline characteristics and risk factors of retinal vein occlusion: a study by the Korean RVO Study Group.

    PubMed

    Lee, Joo Yong; Yoon, Young Hee; Kim, Ha Kyoung; Yoon, Hee Seong; Kang, Se Woong; Kim, June-Gone; Park, Kyu Hyung; Jo, Young Joon

    2013-01-01

    We investigated the demographic characteristics and risk factors of Korean patients with naÏve central or branch retinal vein occlusion (CRVO or BRVO). This study enrolled 41 clinical sites throughout Korea and included 557 consecutive patients with retinal vein occlusion (RVO) from May through November 2010. A total of 557 patients with new-onset RVO participated in this study. Two hundred and three (36.4%) patients were diagnosed with CRVO and 354 (63.6%) patients were diagnosed with BRVO. Comparisons between the two groups showed that the prevalence of diabetes mellitus was significantly higher in CRVO patients and hypertension was significantly higher in BRVO patients (P = 0.001 and 0.002, respectively). Poor baseline visual acuity was significantly associated with female and old age in BRVO patients (P = 0.002 and 0.013, respectively), whereas the wide intraretinal hemorrhage (CRVO, P = 0.029; BRVO, P < 0.001) and the macular ischemia (CRVO, P < 0.001; BRVO, P < 0.001) were associated with both groups. The study results show the clinical features of RVO in Korean patients. Hypertension is strongly associated with BRVO and diabetes mellitus is more strongly associated with CRVO in Korean patients with RVO. As the first nationwide study performed by the Korean Retinal Society, the results of this study can be applied to future studies on RVO.

  19. Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate [ISRCTN64783481

    PubMed Central

    2005-01-01

    Objective The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study is examining the effects of long-term fibrate therapy on coronary heart disease (CHD) event rates in patients with diabetes mellitus. This article describes the trial's run-in phase and patients' baseline characteristics. Research design and methods FIELD is a double-blind, placebo-controlled trial in 63 centres in 3 countries evaluating the effects of fenofibrate versus placebo on CHD morbidity and mortality in 9795 patients with type 2 diabetes mellitus. Patients were to have no indication for lipid-lowering therapy on randomization, but could start these or other drugs at any time after randomization. Follow-up in the study was to be for a median duration of not less than 5 years and until 500 major coronary events (fatal coronary heart disease plus nonfatal myocardial infarction) had occurred. Results About 2100 patients (22%) had some manifestation of cardiovascular disease (CVD) at baseline and thus high risk status. Less than 25% of patients without CVD had a (UKPDS determined) calculated 5-year CHD risk of <5%, but nearly all had a 5-year stroke risk of <10%. Despite this, half of the cohort were obese (BMI > 30), most were men, two-thirds were aged over 60 years, and substantial proportions had NCEP ATP III features of the metabolic syndrome independent of their diabetes, including low HDL (60%), high blood pressure measurement or treatment for hypertension (84%), high waist measurement (68%), and raised triglycerides (52%). After a 6-week run-in period before randomisation with all participants receiving 200 mg comicronized fenofibrate, there were declines in total and LDL cholesterol (10%) and triglycerides (26%) and an increase in HDL cholesterol (6.5%). Conclusion The study will show the effect of PPAR-alpha agonist action on CHD and other vascular outcomes in patients with type 2 diabetes including substantial numbers with low to moderate CVD risk but with the various

  20. 21-cm Observations with the NASA ADAS 18-meter Antenna System: Baseline Astronomical Observations and Measurements of Performance Characteristics

    NASA Astrophysics Data System (ADS)

    Malphrus, B. K.; Combs, M. S.; Kruth, J.

    2001-12-01

    Herein we report astronomical observations made with the NASA Advanced Data Acquisition System (ADAS). The NASA ADAS antenna, located at NASA Goddard Spaceflight Center's Wallops Flight Facility, Virginia, is an 18-meter X-band antenna system that has been primarily used for satellite tracking and served as the telecommunication station for the NASA IUE satellite until ca. 1997. A joint NASA-Morehead State University (MSU)-Kentucky NSF EPSCoR venture has been initiated to upgrade and relocate the antenna system to MSU's Astrophysics Laboratory where it will provide a research instrument and active laboratory for undergraduate students as well as be engaged in satellite tracking missions. As part of the relocation efforts, many systems will be upgraded including replacement of a hydrostatic azimuth bearing with a high-precision electromechanical bearing, a new servo system, and Ku-capable reflector surface. It is widely believed that there are still contributions that small aperture centimeter-wave instruments can make utilizing three primary observing strategies: 1.) longitudinal studies of RF variations in cosmic phenomena, 2.) surveys of large areas of sky, and 3.) fast reactions to transient phenomena. MSU faculty and staff along with NASA engineers re-outfitted the ADAS system with RF systems and upgraded servo controllers during the spring and summer of 2001. Empirical measurements of primary system performance characteristics were made including G/T (at S- and L bands), noise figures, pointing and tracking accuracies, and drive speeds and accelerations. Baseline astronomical observations were made with the MSU L-band receiver using a 6 MHz bandwidth centered at 1420 MHz (21-cm) and observing over a range of frequencies (up to 2.5 MHz, tunable over the 6 MHz window) with a 2048-channel back-end spectrometer, providing up to 1 KHz frequency resolution. Baseline observations of radio sources herein reported include Cygnus A, 3C 157, 3C 48 and the Andromeda

  1. A prospective cohort study of modifiable risk factors for gestational diabetes among Hispanic women: design and baseline characteristics.

    PubMed

    Chasan-Taber, Lisa; Fortner, Renée Turzanski; Gollenberg, Audra; Buonnaccorsi, John; Dole, Nancy; Markenson, Glenn

    2010-01-01

    Women diagnosed with gestational diabetes mellitus (GDM) are at high risk for future diabetes, with rates of GDM consistently higher in Hispanic than non-Hispanic white women. Currently recognized risk factors for GDM are absent in up to half of affected women, and studies addressing modifiable risk factors for GDM in Hispanic women are sparse. Proyecto Buena Salud is an ongoing prospective cohort study of Hispanic women in Massachusetts designed to assess physical activity, psychosocial stress, and GDM risk. Bilingual interviewers recruit prenatal care patients early in pregnancy and assess activity, trait anxiety, perceived stress, and depressive symptoms using validated questionnaires. Baseline characteristics of the first 632 participants are presented. Women were predominantly young (69% <24 years), were unmarried (87%), and had low levels of education (48% had less than high school). Women with high acculturation were less likely to live with a partner (OR: 0.6, 95% CI 0.4-0.8) than women with low acculturation. Few participants met physical activity guidelines during pregnancy (5.2%). Levels of perceived stress (mean 26.9 +/- 7.1), trait anxiety (mean 41.6 +/- 10.4), and depressive symptoms (33.2%) were high. Proyecto Buena Salud represents a high-risk population of pregnant Hispanic women who are predominantly inactive, with higher levels of perceived stress, trait anxiety, and depressive symptoms compared to predominantly non-Hispanic white cohorts studied earlier. Therefore, Proyecto Buena Salud provides a unique opportunity to prospectively evaluate modifiable risk factors for GDM. Findings will inform prenatal behavioral intervention programs designed to address modifiable GDM risk factors.

  2. eMoms: Electronically-Mediated Weight Interventions for Pregnant and Postpartum Women. Study Design and Baseline Characteristics

    PubMed Central

    Groth, Susan W.; Reschke, Jennifer E.; Graham, Meredith L.; Strawderman, Myla; Olson, Christine M.

    2015-01-01

    Background The influence of childbearing in the development of obesity is situated within two different but related contexts: pregnancy-related weight gain and weight gain prevention and control in young adult women. Pregnancy related weight gain contributes to long-term weight retention in childbearing women. Objective To present the study design, data collection procedures, recruitment challenges, and the baseline characteristics for the eMoms of Rochester study, a randomized clinical trial testing the effect of electronically-mediated behavioral interventions to prevent excessive gestational weight gain (GWG) and postpartum weight retention among women aged 18–35 years of diverse income and racial/ethnic backgrounds in an urban setting. Design Randomized double blind clinical trial. A total of 1,722 women at or below 20 weeks gestation were recruited primarily from obstetrics practices and randomized to 3 treatment groups: control arm; intervention arm with access to intervention during pregnancy and control at postpartum (e-intervention 1); and intervention arm with access to intervention during pregnancy and postpartum (e-intervention 2). Enrollment and consent were completed via study staff or online. Data were collected via online surveys, medical charts, and measurement of postpartum weights. The primary endpoints are gaining more weight than recommended by the Institution of Medicine guidelines and weight retained at 12 months postpartum. Conclusion This study will provide evidence on the efficacy of behavioral interventions in the prevention of excessive GWG and postpartum weight retention with potential dissemination to obstetrics practices and/or health insurances. PMID:25957183

  3. CKD in Hispanics: Baseline characteristics from the CRIC (Chronic Renal Insufficiency Cohort) and Hispanic-CRIC Studies.

    PubMed

    Fischer, Michael J; Go, Alan S; Lora, Claudia M; Ackerson, Lynn; Cohan, Janet; Kusek, John W; Mercado, Alejandro; Ojo, Akinlolu; Ricardo, Ana C; Rosen, Leigh K; Tao, Kaixiang; Xie, Dawei; Feldman, Harold I; Lash, James P

    2011-08-01

    Little is known regarding chronic kidney disease (CKD) in Hispanics. We compared baseline characteristics of Hispanic participants in the Chronic Renal Insufficiency Cohort (CRIC) and Hispanic-CRIC (H-CRIC) Studies with non-Hispanic CRIC participants. Cross-sectional analysis. Participants were aged 21-74 years with CKD using age-based estimated glomerular filtration rate (eGFR) at enrollment into the CRIC/H-CRIC Studies. H-CRIC included Hispanics recruited at the University of Illinois in 2005-2008, whereas CRIC included Hispanics and non-Hispanics recruited at 7 clinical centers in 2003-2007. Race/ethnicity. Blood pressure, angiotensin-converting enzyme (ACE)-inhibitor/angiotensin receptor blocker (ARB) use, and CKD-associated complications. Demographic characteristics, laboratory data, blood pressure, and medications were assessed using standard techniques and protocols. Of H-CRIC/CRIC participants, 497 were Hispanic, 1,650 were non-Hispanic black, and 1,638 were non-Hispanic white. Low income and educational attainment were nearly twice as prevalent in Hispanics compared with non-Hispanics (P < 0.01). Hispanics had self-reported diabetes (67%) more frequently than non-Hispanic blacks (51%) and whites (40%; P < 0.01). Blood pressure >130/80 mm Hg was more common in Hispanics (62%) than blacks (57%) and whites (35%; P < 0.05), and abnormalities in hematologic, metabolic, and bone metabolism parameters were more prevalent in Hispanics (P < 0.05), even after stratifying by entry eGFR. Hispanics had the lowest use of ACE inhibitors/ARBs among the high-risk subgroups, including participants with diabetes, proteinuria, and blood pressure >130/80 mm Hg. Mean eGFR was lower in Hispanics (39.6 mL/min/1.73 m(2)) than in blacks (43.7 mL/min/1.73 m(2)) and whites (46.2 mL/min/1.73 m(2)), whereas median proteinuria was higher in Hispanics (protein excretion, 0.72 g/d) than in blacks (0.24 g/d) and whites (0.12 g/d; P < 0.01). Generalizability; observed associations limited

  4. CKD in Hispanics: Baseline Characteristics From the CRIC (Chronic Renal Insufficiency Cohort) and Hispanic-CRIC Studies

    PubMed Central

    Fischer, Michael J.; Go, Alan; Lora, Claudia M.; Ackerson, Lynn; Cohan, Janet; Kusek, John; Mercado, Alejandro; Ojo, Akinlolu; Ricardo, Ana C.; Rosen, Leigh; Tao, Kelvin; Xie, Dawei; Feldman, Harold; Lash, James P.

    2012-01-01

    Background Little is known regarding chronic kidney disease (CKD) in Hispanics. We compared baseline characteristics of Hispanic participants in the Chronic Renal Insufficiency Cohort (CRIC) and Hispanic-CRIC (H-CRIC) Studies with non-Hispanic CRIC participants. Study Design Cross-sectional analysis Setting and Participants Participants were aged 21–74 years with CKD using age-based glomerular filtration rate (eGFR) at enrollment into the CRIC/H-CRIC Studies. H-CRIC included Hispanics recruited at the University of Illinois from 2005–2008 while CRIC included Hispanics and non-Hispanics recruited at seven clinical centers from 2003–2007. Factor Race/ethnicity Outcomes Blood pressure, angiotensin-converting enzyme (ACE) inhibitor/angiotensin receptor blocker (ARB) use, CKD-associated complications Measurements Demographic characteristics, laboratory data, blood pressure, and medications were assessed using standard techniques and protocols Results Among H-CRIC/ CRIC participants, 497 were Hispanic, 1650 non-Hispanic Black, and 1638 non-Hispanic White. Low income and educational attainment were nearly twice as prevalent in Hispanics compared with non-Hispanics (p<0.01). Hispanics had self-reported diabetes (67%) more frequently than non-Hispanic Blacks (51%) and Whites (40%) (p<0.01). Blood pressure > 130/80 mmHg was more common in Hispanics (62%) compared with Blacks (57%) and Whites (35%) (p<0.05), and abnormalities in hematologic, metabolic, and bone metabolism parameters were more prevalent in Hispanics (p<0.05), even after stratifying by entry eGFR. Hispanics had the lowest receipt of ACE inhibitor/ARB among high-risk subgroups, including participants with diabetes, proteinuria, and blood pressure > 130/80 mmHg. Mean eGFR (ml/min/m2) was lower in Hispanics (39.6) than in Blacks (43.7) and Whites (46.2), while median proteinuria was higher in Hispanics (0.72 g/d) than in Blacks (0.24 g/d) and Whites (0.12 g/d) (p<0.01). Limitations Generalizability; observed

  5. Baseline characteristics from an ongoing phase 3 study of collagenase clostridium histolyticum in patients with Peyronie's disease.

    PubMed

    Gelbard, Martin; Hellstrom, Wayne J G; McMahon, Chris G; Levine, Laurence A; Smith, Ted; Tursi, James; Kaufman, Gregory; Goldstein, Irwin

    2013-11-01

    Peyronie's disease (PD) is a localized penile collagen disorder of the tunica albuginea associated with significant physical deformity and psychological impairment. Current understanding of pretreatment characteristics in patients with chronic PD is limited by small samples, varied quality of assessments, and the lack of a PD-specific, validated measure of the psychosexual impact of PD. Reporting baseline demographic and disease characteristics of the large multinational cohort of subjects with chronic PD who participated in the collagenase clostridium histolyticum (CCH, an investigational intralesional injection and minimally invasive intervention) phase 3 clinical study program. Findings from well-defined assessments, including the Peyronie's Disease Questionnaire (PDQ), the first validated PD-specific patient-reported measure of psychosexual impact, are reported. Subjects included men≥18 years old with PD symptoms≥12 months and penile deformity between 30° and 90°. Analysis data included demographics, disease history, and psychosexual impact. Penile deformity, disease symptoms, the International Index of Erectile Function, and the PDQ were assessed. Eight hundred thirty-two subjects were enrolled from 64 sites across the United States and Australia. The mean age was 57.7 years; mean PD duration was 4.1 years. The majority of subjects had penile deformity≤60° (77.3%); mean penile deformity was 50.5°. Subjects reported having intercourse a mean of 10.2 times in the previous 3 months, 70.8% reported difficulty in performing vaginal intercourse, and 80.4% reported less frequent vaginal intercourse. Approximately 71.5% of subjects with severe (>60°) and 58.1% of subjects with mild/moderate (≤60°) penile deformity were "very bothered" or "extremely bothered" upon last look at their erect penis (P=0.0041), as measured by the PDQ. These data add to the body of knowledge regarding the clinical impact of chronic phase PD, including the PD-specific patient

  6. AGING AND ACTIVITY: BASELINE CHARACTERISTICS OF MOTOR ACTIVITY AND THE EFFECT OF TOLUENE IN BROWN NORWAY RATS.

    EPA Science Inventory

    The rapidly aging population raises many uncertainties regarding the susceptibility of older adults to environmental pollutants. Research to reduce these uncertainties must consider age-related changes in baseline function and its variability. For example, activity levels are gen...

  7. Baseline characteristics of HIV & hepatitis B virus (HIV/HBV) co-infected patients from Kolkata, India

    PubMed Central

    Sarkar, Jayeeta; Saha, Debraj; Bandyopadhyay, Bhaswati; Saha, Bibhuti; Kedia, Deepika; Guha Mazumder, D.N.; Chakravarty, Runu; Guha, Subhasish Kamal

    2016-01-01

    Background & objectives: Hepatitis B virus (HBV) and HIV co-infection has variable prevalence worldwide. In comparison to HBV mono-infection, the course of chronic HBV infection is accelerated in HIV/HBV co-infected patients. The present study was carried out to analyse the baseline characteristics (clinical, biochemical, serological and virological) of treatment naïve HIV/HBV co-infected and HIV mono-infected patients. Methods: Between July 2011 and January 2013, a total number of 1331 HIV-seropositive treatment naïve individuals, enrolled in the ART Centre of Calcutta School of Tropical Medicine, Kolkata, India, were screened for hepatitis B surface antigen (HBsAg). A total of 1253 HIV mono-infected and 78 HIV/HBV co-infected patients were characterized. The co-infected patients were evaluated for HBeAg and anti-HBe antibody by ELISA. HIV RNA was quantified for all co-infected patients. HBV DNA was detected and quantified by real time-PCR amplification followed by HBV genotype determination. Results: HIV/HBV co-infected patients had proportionately more advanced HIV disease (WHO clinical stage 3 and 4) than HIV mono-infected individuals (37.1 vs. 19.9%). The co-infected patients had significantly higher serum bilirubin, alanine aminotransferase (ALT), alkaline phosphatase and ALT/platelet ratio index (APRI). CD4 count was non-significantly lower in co-infected patients. Majority (61.5%) were HBeAg positive with higher HIV RNA (P<0.05), HBV DNA (P<0.001) and APRI (P<0.05) compared to those who were HBeAg negative. HBV/D was the predominant genotype (73.2%) and D2 (43.7%) was the commonest subgenotype. Interpretation & conclusions: HIV/HBV co-infected patients had significantly higher serum bilirubin, ALT, alkaline phosphatase and lower platelet count. HBeAg positive co-infected patients had higher HIV RNA and HBV DNA compared to HBeAg negative co-infected patients. Prior to initiation of antiretroviral treatment (ART) all patients should be screened for HBsAg to

  8. Cataract Surgery in Children from Birth to Less than 13 Years of Age: Baseline Characteristics of the Cohort.

    PubMed

    Repka, Michael X; Dean, Trevano W; Lazar, Elizabeth L; Yen, Kimberly G; Lenhart, Phoebe D; Freedman, Sharon F; Hug, Denise; Rahmani, Bahram; Wang, Serena X; Kraker, Raymond T; Wallace, David K

    2016-12-01

    To describe baseline characteristics, initial postoperative refractive errors, operative complications, and magnitude of the intraocular lens (IOL) prediction error for refractive outcome in children undergoing lensectomy largely in North America. Prospective registry study of children from birth to <13 years of age who underwent lensectomy for any reason within 45 days preceding enrollment. Total of 1266 eyes of 994 children; 49% female and 59% white. Measurement of refractive error, axial length, and complete ophthalmic examination. Eye and systemic associated conditions, IOL style, refractive error, pseudophakic refraction prediction error, operative and perioperative complications. Mean age at first eligible lens surgery was 4.2 years; 337 (34%) were <1 year of age. Unilateral surgery was performed in 584 children (59%). Additional ocular abnormalities were noted in 301 eyes (24%). An IOL was placed in 35 of 460 eyes (8%) when surgery was performed before 1 year of age, in 70 of 90 eyes (78%) from 1 to <2 years of age, and in 645 of 716 eyes (90%) from 2 to <13 years of age. The odds of IOL implantation were greater in children ≥2 years of age than in those <2 years of age (odds ratio = 29.1; P < 0.001; 95% confidence interval: 19.6-43.3). Intraoperative complications were reported for 69 eyes (5%), with the most common being unplanned posterior capsule rupture in 14 eyes, 10 of which had an IOL placed. Prediction error of the implanted IOL was <1.00 diopter in 54% of eyes, but >2.00 diopters in 15% of eyes. Lensectomy surgery was performed throughout childhood, with about two-thirds of cases performed after 1 year of age. Initial surgery seemed safe, with a low complication rate. IOL placement was nearly universal in children 2 years of age and older. The immediate postoperative refraction was within 1 diopter of the target for about one-half of eyes. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  9. Recruitment and Baseline Characteristics of American Indian Tribal College Students Participating in a Tribal College Tobacco and Behavioral Survey

    PubMed Central

    Nazir, Niaman; Pacheco, Christina M.; Filippi, Melissa K.; Pacheco, Joseph; White Bull, Julia; Nance, Christi; Faseru, Babalola; Greiner, K. Allen; Daley, Christine Makosky

    2016-01-01

    Introduction: American Indians (AIs) have the highest cigarette smoking rates of any racial/ethnic group in the United States. Although the overall smoking prevalence in the United States for nonminority populations has decreased over the past several decades, the same pattern is not observed among AIs. The purpose of this observational study was to collect cigarette smoking and related information from American Indian tribal college students to inform tailored interventions. Methods: We conducted a repeated cross-sectional survey of American Indian tribal college students, Tribal College Tobacco and Behavior Survey (TCTABS), with a focus on recruiting all incoming freshman at three participating tribal colleges in the Midwest and Northern Plains regions. A total of 1256 students participated in the baseline surveys between April 2011 and October 2014. Results: The overall smoking prevalence of this sample was 34.7%, with differences by region (Northern Plains—44.0% and Midwest—28%). The majority, 87.5% of current smokers reported smoking 10 or less cigarettes per day, 41% reported smoking menthol cigarettes, 52% smoked Marlboro brand, and the mean age of their first cigarette was 14 years. The majority, 62% had made at least one quit attempt in the past year. The overwhelming majority of respondents, regardless of their smoking status, thought that the current smoking prevalence on campus was greater than 41% and approximately one-third believed that it was as high as 61%. Conclusions: Very few studies of smoking have been conducted in this population and results from our study confirm the need for effective interventions. Implications: AIs have the highest cigarette smoking rates compared to other racial/ethnic groups in the United States. Furthermore, limited studies have examined the epidemiology of cigarette smoking among tribal college students. This study addresses health disparities related to smoking among college students by examining the demographic

  10. Involvement of stanniocalcins in the deregulation of glycaemia in obese mice and type 2 diabetic patients.

    PubMed

    López, José Javier; Jardín, Isaac; Chamorro, Carlos Cantonero; Duran, Manuel Luis; Tarancón Rubio, María José; Reyes Panadero, Maria; Jiménez, Francisca; Montero, Rocio; González, María José; Martínez, Manuel; Hernández, María Jose; Brull, José María; Corbacho, Antonio Jesús; Delgado, Elena; Granados, María Purificación; Gómez-Gordo, Luis; Rosado, Juan Antonio; Redondo, Pedro Cosme

    2017-10-09

    Stanniocalcins are expressed in the pancreas tissue, and it was suggested a direct correlation between circulating insulin and STC2 concentrations in human. Here, we show a significant correlation between STC1 and both glycaemia and glycosylated haemoglobin among DM2 patients, while DM2 patients who present the greatest glycosylated haemoglobin values exhibited the lowest STC2 expression. However, treatment of patients with antiglycaemic drugs does not significantly modify the expression of both STCs. On the other hand, STC2(-/-) mice that exhibited neonatal and adult overweight further presented deregulated glycaemia when they were feed with a hypercaloric diet (breeding pellet, BP). This alteration is more evident at the early stages of the animal life. Deregulated glycaemia in these mice was confirmed using glucose oral test. In addition, STC2(-/-) mice present enhanced pancreas size; thus, the histological analysis reveals that WT mice respond to BP diet by increasing the size of the pancreatic islets through inducing cell division, and STC2(-/-) mice lack this compensatory mechanism. Contrary, BP fed STC2(-/-) mice show enhanced number of islets but of similar size than those fed with regular pellet. Histopathological analysis demonstrates tissue structure disruption and erythrocytes infiltrations in STC2(-/-) mice, possibly due to the stress evoked by the BP diet. Finally, enhanced glucagon immunostaining was observed in the islet of STC2(-/-) mice, and the glucagon ELISA assay confirmed the increase in the circulating glucagon. Summarizing, we present evidence of the role of STCs, mainly STC2, as a possible early marker during development of diabetes mellitus. © 2017 The Authors. Journal of Cellular and Molecular Medicine published by John Wiley & Sons Ltd and Foundation for Cellular and Molecular Medicine.

  11. Baseline characteristics of patients with chronic kidney disease stage 3 and stage 4 in spain: the MERENA observational cohort study

    PubMed Central

    2011-01-01

    Background To obtain information on cardiovascular morbidity, hypertension control, anemia and mineral metabolism based on the analysis of the baseline characteristics of a large cohort of Spanish patients enrolled in an ongoing prospective, observational, multicenter study of patients with stages 3 and 4 chronic kidney diseases (CKD). Methods Multicenter study from Spanish government hospital-based Nephrology outpatient clinics involving 1129 patients with CKD stages 3 (n = 434) and 4 (n = 695) defined by GFR calculated by the MDRD formula. Additional analysis was performed with GFR calculated using the CKD-EPI and Cockcroft-Gault formula. Results In the cohort as a whole, median age 70.9 years, morbidity from all cardiovascular disease (CVD) was very high (39.1%). In CKD stage 4, CVD prevalence was higher than in stage 3 (42.2 vs 35.6% p < 0.024). Subdividing stage 3 in 3a and 3b and after adjusting for age, CVD increased with declining GFR with the hierarchy (stage 3a < stage 3b < stage 4) when calculated by CKD-EPI (31.8, 35.4, 42.1%, p 0.039) and Cockcroft-Gault formula (30.9, 35.6, 43.4%, p 0.010) and MDRD formula (32.5, 36.2, 42.2%,) but with the latter, it did not reach statistical significance (p 0.882). Hypertension was almost universal among those with stages 3 and 4 CKD (91.2% and 94.1%, respectively) despite the use of more than 3 anti-hypertensive agents including widespread use of RAS blockers. Proteinuria (> 300 mg/day) was present in more than 60% of patients and there was no significant differences between stages 3 and 4 CKD (1.2 ± 1.8 and 1.3 ± 1.8 g/day, respectively). A majority of the patients had hemoglobin levels greater than 11 g/dL (91.1 and 85.5% in stages 3 and 4 CKD respectively p < 0.001) while the use of erythropoiesis-stimulating agents (ESA) was limited to 16 and 34.1% in stages 3 and 4 CKD respectively. Intact parathyroid hormone (i-PTH) was elevated in stage 3 and stage 4 CKD patients (121 ± 99 and 166 ± 125 pg/mL p 0

  12. Association of Baseline Characteristics and Early Vision Response with Two-Year Vision Outcomes in the Comparison of AMD Treatments Trials (CATT)

    PubMed Central

    Ying, Gui-shuang; Maguire, Maureen G.; Daniel, Ebenezer; Ferris, Frederick L; Jaffe, Glenn J.; Grunwald, Juan E.; Toth, Cynthia; Huang, Jiayan; Martin, Daniel F.

    2015-01-01

    Objective To evaluate the association of baseline characteristics and early visual acuity (VA) response with visual outcomes at Years 1 or 2 in the Comparison of Age-related Macular Degeneration (AMD) Treatments Trials (CATT). Design Secondary analysis of a randomized clinical trial. Participants 1185 patients with neovascular AMD and baseline VA 20/25 to 20/320. Methods Patients were assigned to ranibizumab or bevacizumab and to one of 3 dosing regimens. VA responses were classified as ≥3-lines gain/loss, 1–2 lines gain/loss, or within one-line change from baseline. Associations of baseline characteristics and early VA response (week 4 or 12) with VA response at Years 1 or 2 were assessed by R2 from linear regression analyses. Patients who had a poor initial response (VA 20/40 or worse with persistent fluid and without ≥1-line VA gain) were defined as candidates for “switching” based on estimates of current clinical practice. Main Outcome Measures VA change from baseline. Results Statistically significant (p<0.05) baseline predictors for less VA gain at Year 2 were older age, VA 20/40 or better, larger CNV area, presence of GA, total foveal thickness ≤325 or >425 microns, and elevation of retinal pigment epithelium. Among 176 eyes gaining ≥3 lines at week 12, 78% had a ≥3-line gain at Year 2, while among 113 eyes losing ≥1 line at week 12, 27% improved to a ≥1 line gain at Year 2. VA response at week 12 was more predictive of VA response at Year 2 (R2=0.30) than VA response at week 4 (R2=0.17) and baseline predictors (R2=0.13) (p<0.0001). Among 126 candidates for “switching” drug at week 12, mean VA improved 2.8 letters (p=0.050), mean total retinal thickness decreased 53u (p<0.0001), and fluid resolved in 33% (p<0.0001) between week 12 and Year 1 with continued use of the same drug and regimen. Similar improvements were observed among 83 candidates for “switching” at week 24. Conclusion VA response at week 12 is more predictive of two

  13. Effects of human milk and formula on postprandial glycaemia and insulinaemia.

    PubMed

    Wright, C J; Atkinson, F S; Ramalingam, N; Buyken, A E; Brand-Miller, J C

    2015-08-01

    Consumption of formula in place of human milk may produce differences in postprandial glycaemia and insulinaemia that contribute to metabolic programming in the first year of life. The objective of the current study was to determine glycaemic and insulinaemic responses to human milk compared with a typical commercial formula, and then compare 11 other formulas. On separate mornings in random order, 10 healthy breastfeeding mothers consumed 25 g available carbohydrate portions of their own milk, a formula and reference food (25 g glucose on two occasions). In the second study, 10 different healthy subjects consumed 25 g available carbohydrate portions of 11 different commercial formulas and three reference foods (25 g glucose on three occasions). Fingerpick blood samples were taken at regular intervals over 2 h, and the glycaemic index (GI) and insulin index determined according to a standardised protocol. There were no significant differences in postprandial glycaemia or insulinaemia after human milk vs a typical formula (P = 0.3). Both produced a low GI (mean ± s.e.m.: 38 ± 7 vs 34 ± 7, respectively) and high insulin index (87 ± 14 vs 94 ± 16). The GI and insulin indices of the other formulas ranged from 18 ± 3 to 67 ± 6 and 53 ± 9 to 209 ± 33, respectively. Human milk and a typical formula elicit similar postprandial glycaemic and insulinaemic responses, but there is a wide range of responses to other formulas.

  14. Postprandial Levels of Branch Chained and Aromatic Amino Acids Associate with Fasting Glycaemia

    PubMed Central

    Ottosson, Filip; Ericson, Ulrika; Almgren, Peter; Nilsson, Jeanette; Magnusson, Martin; Fernandez, Céline; Melander, Olle

    2016-01-01

    High fasting plasma concentrations of isoleucine, phenylalanine, and tyrosine have been associated with increased risk of hyperglycaemia and incidence of type 2 diabetes. Whether these associations are diet or metabolism driven is unknown. We examined how the dietary protein source affects the postprandial circulating profile of these three diabetes associated amino acids (DMAAs) and tested whether the postprandial DMAA profiles are associated with fasting glycaemia. We used a crossover design with twenty-one healthy individuals and four different isocaloric test meals, containing proteins from different dietary sources (dairy, fish, meat, and plants). Analysis of the postprandial DMAAs concentrations was performed using targeted mass spectrometry. A DMAA score was defined as the sum of all the three amino acid concentrations. The postprandial area under the curve (AUC) of all the three amino acids and the DMAA score was significantly greater after intake of the meal with dairy protein compared to intake of the three other meals. The postprandial AUC for the DMAA score and all the three amino acids strongly associated with fasting glucose level and insulin resistance. This indicates the importance of the postprandial kinetics and metabolism of DMAAs in understanding the overall association between DMAAs and glycaemia. PMID:27274867

  15. Tiotropium improves lung function, exacerbation rate, and asthma control, independent of baseline characteristics including age, degree of airway obstruction, and allergic status.

    PubMed

    Kerstjens, Huib A M; Moroni-Zentgraf, Petra; Tashkin, Donald P; Dahl, Ronald; Paggiaro, Pierluigi; Vandewalker, Mark; Schmidt, Hendrik; Engel, Michael; Bateman, Eric D

    2016-08-01

    Many patients with asthma remain symptomatic despite treatment with inhaled corticosteroids (ICS) with or without long-acting β2-agonists (LABAs). Tiotropium add-on to ICS plus a LABA has been shown to improve lung function and reduce exacerbation risk in patients with symptomatic asthma. To determine whether the efficacy of tiotropium add-on therapy is dependent on patients' baseline characteristics. Two randomized, double-blind, parallel-group, twin trials (NCT00772538 and NCT00776984) of once-daily tiotropium Respimat(®) 5 μg add-on to ICS plus a LABA were performed in parallel in patients with severe symptomatic asthma. Exploratory subgroup analyses of peak forced expiratory volume in 1 s (FEV1), trough FEV1, time to first severe exacerbation, time to first episode of asthma worsening, and seven-question Asthma Control Questionnaire responder rate were performed to determine whether results were influenced by baseline characteristics. 912 patients were randomized: 456 received tiotropium and 456 received placebo. Tiotropium improved lung function, reduced the risk of asthma exacerbations and asthma worsening, and improved asthma symptom control, compared with placebo, independent of baseline characteristics including gender, age, body mass index, disease duration, age at asthma onset, and FEV1 % predicted at screening and reversibility. Once-daily tiotropium 5 μg compared with placebo improved lung function, reduced the risk of asthma exacerbations and asthma worsening, and improved asthma symptom control, independent of a broad range of baseline characteristics, as add-on to ICS plus LABAs in patients with severe symptomatic asthma. ClinicalTrials.gov; numbers NCT00772538 and NCT00776984 URL: www.clinicaltrials.gov. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  16. The Natural History of the Progression of Atrophy Secondary to Stargardt Disease (ProgStar) Studies: Design and Baseline Characteristics: ProgStar Report No. 1.

    PubMed

    Strauss, Rupert W; Ho, Alex; Muñoz, Beatriz; Cideciyan, Artur V; Sahel, José-Alain; Sunness, Janet S; Birch, David G; Bernstein, Paul S; Michaelides, Michel; Traboulsi, Elias I; Zrenner, Eberhart; Sadda, SriniVas; Ervin, Ann-Margret; West, Sheila; Scholl, Hendrik P N

    2016-04-01

    To describe the design and baseline characteristics of patients enrolled into 2 natural history studies of Stargardt disease (STGD1). Multicenter retrospective and prospective cohort studies. Three hundred sixty-five unique patients aged 6 years and older at baseline harboring disease-causing variants in the ABCA4 gene and with specified ocular lesions were enrolled from 9 centers in the United States and Europe. In the retrospective study, patients contributed medical record data from at least 2 and up to 4 visits for at least 1 examination modality: fundus autofluorescence (FAF), spectral-domain (SD) optical coherence tomography (SD OCT), and/or microperimetry (MP). The total observational period was at least 2 years and up to 5 years between single visits. Demographic and visual acuity (VA) data also were obtained. In the prospective study, eligible patients were examined at baseline using a standard protocol, with 6-month follow-up visits planned for a 2-year period for serial Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected VA, SD OCT, FAF, and MP. Design and rationale of a multicenter study to determine the progression of STGD1 in 2 large retrospective and prospective international cohorts. Detailed baseline characteristics of both cohorts are presented, including demographics, and structural and functional retinal metrics. Into the retrospective study, 251 patients (458 eyes) were enrolled; mean follow-up ± standard deviation was 3.9±1.6 years. At baseline, 36% had no or mild VA loss, and 47% of the study eyes had areas of definitely decreased autofluorescence (DDAF) with an average lesion area of 2.5±2.9 mm(2) (range, 0.02-16.03 mm(2)). Two hundred fifty-nine patients (489 eyes) were enrolled in the prospective study. At baseline, 20% had no or mild VA loss, and 64% had areas of DDAF with an average lesion area of 4.0±4.4 mm(2) (range, 0.03-24.24 mm(2)). The mean retinal sensitivity with MP was 10.8±5.0 dB. The ProgStar cohorts have

  17. Association of Baseline Characteristics and Early Vision Response with 2-Year Vision Outcomes in the Comparison of AMD Treatments Trials (CATT).

    PubMed

    Ying, Gui-shuang; Maguire, Maureen G; Daniel, Ebenezer; Ferris, Frederick L; Jaffe, Glenn J; Grunwald, Juan E; Toth, Cynthia A; Huang, Jiayan; Martin, Daniel F

    2015-12-01

    To evaluate the association of baseline characteristics and early visual acuity (VA) response with visual outcomes at years 1 or 2 in the Comparison of Age-Related Macular Degeneration (AMD) Treatments Trials (CATT). Secondary analysis of CATT. The 1185 CATT participants with baseline VA of 20/25 to 20/320. Participants were assigned to ranibizumab or bevacizumab and to 1 of 3 dosing regimens. Associations of baseline characteristics and early VA response (week 4 or 12) with VA response at years 1 or 2 were assessed by R(2) from linear regression analyses. Patients who had a poor initial response (VA 20/40 or worse with persistent fluid and without ≥1-line VA gain) were defined as candidates for changing treatment. Visual acuity change from baseline. Statistically significant (P < 0.05) baseline predictors for less VA gain at year 2 were older age, VA of 20/40 or better, larger choroidal neovascularization area, presence of geographic atrophy, total foveal thickness ≤325 μm or ≥425 μm, and elevation of retinal pigment epithelium. Among 176 eyes gaining ≥3 lines at week 12, 78% had a ≥3-line gain at year 2, whereas among 113 eyes losing ≥1 line at week 12, 27% improved to a ≥1-line gain at year 2. Visual acuity response at week 12 was more predictive of VA response at year 2 (R(2) = 0.30) than VA response at week 4 (R(2) = 0.17) and baseline predictors (R(2) = 0.13; P < 0.0001). Among 126 candidates for changing treatment drug at week 12, mean VA improved by 2.8 letters (P = 0.050), mean total retinal thickness decreased 53 μm (P < 0.0001), and fluid resolved in 33% (P < 0.0001) between week 12 and year 1 with continued use of the same drug and regimen. Similar improvements were observed among 83 candidates for changing drugs at week 24. Visual acuity response at week 12 is more predictive of 2-year vision outcomes than either several baseline characteristics or week 4 response. Eyes with poor initial response may benefit from continued treatment

  18. Latanoprost and Dorzolamide for the Treatment of Pediatric Glaucoma: The Glaucoma Italian Pediatric Study (Gipsy), Design and Baseline Characteristics.

    PubMed

    Quaranta, Luciano; Biagioli, Elena; Galli, Francesca; Poli, Davide; Rulli, Eliana; Riva, Ivano; Hollander, Lital; Katsanos, Andreas; Longo, Antonio; Uva, Maurizio G; Torri, Valter; Weinreb, Robert N

    2016-08-01

    To investigate the efficacy of a treatment strategy with latanoprost and dorzolamide in primary pediatric glaucoma patients partially responsive to surgery. Single arm, prospective, interventional multicenter study. Primary pediatric glaucoma patients younger than 13 years after a single surgical procedure with IOP between 22 and 26 mmHg were considered eligible. At baseline, patients were allocated to latanoprost monotherapy once daily. Depending on intraocular pressure (IOP) reduction at first visit, the patients were allocated to one of three groups: continuation of latanoprost monotherapy, addition of dorzolamide twice daily, or switch to dorzolamide three times daily. The same approach for allocation in medication groups was used in all subsequent visits. Patients in the dorzolamide monotherapy group with IOP reduction <20% from baseline were considered non-responders and withdrawn. Study treatment and patient follow-up will continue for 3 years or until treatment failure. The primary endpoint is the percentage of responders. Secondary endpoints are time to treatment failure and frequency of adverse events. A total of 37 patients (69 eyes) were enrolled. The mean age was 4.0 ± 3.8 years, the female/male ratio was 1/1.7, and the majority of patients were Caucasian. Eighty percent of patients had bilateral glaucoma. Goniotomy was the most frequently performed surgery (38.6%), followed by trabeculotomy (22.8%), trabeculectomy (21.1%), and trabeculectomy plus trabeculotomy (17.5%). The baseline IOP was 23.6 ± 1.5 mmHg. The study population is representative of patients frequently encountered after the first surgery for primary pediatric glaucoma. The study will produce evidence on the medium-term efficacy of a defined pharmacological approach.

  19. The COPE healthy lifestyles TEEN randomized controlled trial with culturally diverse high school adolescents: Baseline characteristics and methods

    PubMed Central

    Melnyk, Bernadette Mazurek; Kelly, Stephanie; Jacobson, Diana; Belyea, Michael; Shaibi, Gabriel; Small, Leigh; O’Haver, Judith; Marsiglia, Flavio Francisco

    2014-01-01

    Obesity and mental health disorders remain significant public health problems in adolescents. Substantial health disparities exist with minority youth experiencing higher rates of these problems. Schools are an outstanding venue to provide teens with skills needed to improve their physical and mental health, and academic performance. In this paper, the authors describe the design, intervention, methods and baseline data for a randomized controlled trial with 779 culturally diverse high-school adolescents in the southwest United States. Aims for this prevention study include testing the efficacy of the COPE TEEN program versus an attention control program on the adolescents’ healthy lifestyle behaviors, Body Mass Index (BMI) and BMI%, mental health, social skills and academic performance immediately following the intervention programs, and at six and 12 months post interventions. Baseline findings indicate that greater than 40% of the sample is either overweight (n = 148, 19.00%) or obese (n = 182, 23.36%). The predominant ethnicity represented is Hispanic (n = 526, 67.52%). At baseline, 15.79%(n = 123) of the students had above average scores on the Beck Youth Inventory Depression subscale indicating mildly (n = 52, 6.68%), moderately (n = 47, 6.03%), or extremely (n = 24, 3.08%) elevated scores (see 1). Anxiety scores were slightly higher with 21.56% (n = 168) reporting responses suggesting mildly (n = 81, 10.40%), moderately (n = 58, 7.45%) or extremely (n = 29, 3.72%) elevated scores. If the efficacy of the COPE TEEN program is supported, it will offer schools a curriculum that can be easily incorporated into high school health courses to improve adolescent healthy lifestyle behaviors, psychosocial outcomes and academic performance. PMID:23748156

  20. China Kadoorie Biobank of 0.5 million people: survey methods, baseline characteristics and long-term follow-up

    PubMed Central

    Chen, Zhengming; Chen, Junshi; Collins, Rory; Guo, Yu; Peto, Richard; Wu, Fan; Li, Liming

    2011-01-01

    Background Large blood-based prospective studies can provide reliable assessment of the complex interplay of lifestyle, environmental and genetic factors as determinants of chronic disease. Methods The baseline survey of the China Kadoorie Biobank took place during 2004–08 in 10 geographically defined regions, with collection of questionnaire data, physical measurements and blood samples. Subsequently, a re-survey of 25 000 randomly selected participants was done (80% responded) using the same methods as in the baseline. All participants are being followed for cause-specific mortality and morbidity, and for any hospital admission through linkages with registries and health insurance (HI) databases. Results Overall, 512 891 adults aged 30–79 years were recruited, including 41% men, 56% from rural areas and mean age was 52 years. The prevalence of ever-regular smoking was 74% in men and 3% in women. The mean blood pressure was 132/79 mmHg in men and 130/77 mmHg in women. The mean body mass index (BMI) was 23.4 kg/m2 in men and 23.8 kg/m2 in women, with only 4% being obese (>30 kg/m2), and 3.2% being diabetic. Blood collection was successful in 99.98% and the mean delay from sample collection to processing was 10.6 h. For each of the main baseline variables, there is good reproducibility but large heterogeneity by age, sex and study area. By 1 January 2011, over 10 000 deaths had been recorded, with 91% of surviving participants already linked to HI databases. Conclusion This established large biobank will be a rich and powerful resource for investigating genetic and non-genetic causes of many common chronic diseases in the Chinese population. PMID:22158673

  1. The COPE healthy lifestyles TEEN randomized controlled trial with culturally diverse high school adolescents: baseline characteristics and methods.

    PubMed

    Melnyk, Bernadette Mazurek; Kelly, Stephanie; Jacobson, Diana; Belyea, Michael; Shaibi, Gabriel; Small, Leigh; O'Haver, Judith; Marsiglia, Flavio Francisco

    2013-09-01

    Obesity and mental health disorders remain significant public health problems in adolescents. Substantial health disparities exist with minority youth experiencing higher rates of these problems. Schools are an outstanding venue to provide teens with skills needed to improve their physical and mental health, and academic performance. In this paper, the authors describe the design, intervention, methods and baseline data for a randomized controlled trial with 779 culturally diverse high-school adolescents in the southwest United States. Aims for this prevention study include testing the efficacy of the COPE TEEN program versus an attention control program on the adolescents' healthy lifestyle behaviors, Body Mass Index (BMI) and BMI%, mental health, social skills and academic performance immediately following the intervention programs, and at six and 12 months post interventions. Baseline findings indicate that greater than 40% of the sample is either overweight (n = 148, 19.00%) or obese (n = 182, 23.36%). The predominant ethnicity represented is Hispanic (n = 526, 67.52%). At baseline, 15.79% (n = 123) of the students had above average scores on the Beck Youth Inventory Depression subscale indicating mildly (n = 52, 6.68%), moderately (n = 47, 6.03%), or extremely (n = 24, 3.08%) elevated scores (see Table 1). Anxiety scores were slightly higher with 21.56% (n = 168) reporting responses suggesting mildly (n = 81, 10.40%), moderately (n = 58, 7.45%) or extremely (n = 29, 3.72%) elevated scores. If the efficacy of the COPE TEEN program is supported, it will offer schools a curriculum that can be easily incorporated into high school health courses to improve adolescent healthy lifestyle behaviors, psychosocial outcomes and academic performance.

  2. Baseline characteristics and treatment patterns of patients with schizophrenia initiated on once-every-three-months paliperidone palmitate in a real-world setting.

    PubMed

    Joshi, Kruti; Lafeuille, Marie-Hélène; Brown, Brianne; Wynant, Willy; Emond, Bruno; Lefebvre, Patrick; Tandon, Neeta

    2017-10-01

    Since May 2015, adult patients with schizophrenia adequately treated with once monthly paliperidone palmitate (PP1M) may be transitioned to once-every-three-months paliperidone palmitate (PP3M). This study aims to describe baseline characteristics and treatment patterns of patients with schizophrenia initiated on PP3M in a real-world setting. Pharmacy and medical claims from May 2014 to September 2016 for adult patients with schizophrenia initiated on PP3M (index date) in the Symphony Health Solutions database were analyzed. The cohort consisting of all patients and the one restricted to those transitioning from PP1M as per prescribing guideline recommendations were considered. Baseline characteristics were assessed during the 12 month baseline period. PP1M treatment patterns, proportion of days covered (PDC) by mental-health-related medications, and healthcare resource utilization (HRU) patterns were evaluated for each baseline quarter. PP3M treatment patterns were assessed post-index. Among the 1545 adult patients initiated on PP3M who formed the first cohort, 68.8% transitioned from PP1M based on prescribing guidelines and on an adaptation of the strict clinical trial protocol for PP1M to PP3M transition, forming the second cohort. In both cohorts, the proportion of patients with a PDC ≥80% for antipsychotics, antidepressants, anxiolytics, and mood stabilizers increased while the proportion of patients with ≥1 emergency room, inpatient, or outpatient visit decreased in baseline quarters closer to PP3M initiation. Among patients with ≥4 months of follow-up after the first dose, 85-88% had a second dose. Similarly, among those with ≥4 months of follow-up after the second dose, 87-90% received a third dose. Patients initiated on PP3M demonstrated decreased HRU and increased adherence in quarters closer to PP3M initiation, and were persistent on their PP3M treatment.

  3. Investigation on aerodynamic characteristics of baseline-II E-2 blended wing-body aircraft with canard via computational simulation

    NASA Astrophysics Data System (ADS)

    Nasir, Rizal E. M.; Ali, Zurriati; Kuntjoro, Wahyu; Wisnoe, Wirachman

    2012-06-01

    Previous wind tunnel test has proven the improved aerodynamic charasteristics of Baseline-II E-2 Blended Wing-Body (BWB) aircraft studied in Universiti Teknologi Mara. The E-2 is a version of Baseline-II BWB with modified outer wing and larger canard, solely-designed to gain favourable longitudinal static stability during flight. This paper highlights some results from current investigation on the said aircraft via computational fluid dynamics simulation as a mean to validate the wind tunnel test results. The simulation is conducted based on standard one-equation turbulence, Spalart-Allmaras model with polyhedral mesh. The ambience of the flight simulation is made based on similar ambience of wind tunnel test. The simulation shows lift, drag and moment results to be near the values found in wind tunnel test but only within angles of attack where the lift change is linear. Beyond the linear region, clear differences between computational simulation and wind tunnel test results are observed. It is recommended that different type of mathematical model be used to simulate flight conditions beyond linear lift region.

  4. CHIMES-I: sub-group analyzes of the effects of NeuroAiD according to baseline brain imaging characteristics among patients randomized in the CHIMES study.

    PubMed

    Navarro, Jose C; Chen, Christopher Li Hsian; Lagamayo, Pedro Danilo J; Geslani, Melodia B; Eow, Gaik Bee; Poungvarin, Niphon; de Silva, Asita; Wong, Lawrence K S; Venketasubramanian, N

    2013-08-01

    The clinical effects of neuroprotective and/or neurorestorative therapies may vary according to location and size of the ischemic injury. Imaging techniques can be useful in stratifying patients for trials that may be beneficial against particular ischemic lesion characteristics. To test the hypothesis that the efficacy of NeuroAiD compared with placebo in improving functional outcome and reducing neurological deficit in patients with cerebral infarction of intermediate severity varies between sub-groups of patients randomized in the main Chinese Medicine Neuroaid Efficacy on Stroke study when categorized according to baseline imaging characteristics. This is a retrospective cohort sub-group analysis of patients who participated in the main Chinese Medicine Neuroaid Efficacy on Stroke study, a multicenter, double-blind, placebo-controlled trial that recruited 1100 patients within 72 h of ischemic stroke onset with National Institutes of Health Stroke Scale 6-14 and were randomized to either NeuroAiD or placebo taken four capsules three times daily for three months. Review of the baseline images to classify the acute stroke lesions in terms of size, location, and extent of involvement will be performed retrospectively by two readers who will remain blinded as to treatment allocation and outcomes of the subjects. The primary efficacy end-point in the main Chinese Medicine Neuroaid Efficacy on Stroke study is the modified Rankin Scale grades at three-months. Secondary efficacy end-points are the National Institutes of Health Stroke Scale score at three-months; difference of National Institutes of Health Stroke Scale scores between baseline and 10 days and between baseline and three-months; difference of National Institutes of Health Stroke Scale sub-scores between baseline and 10 days and between baseline and three-months; modified Rankin Scale at 10 days, one-month, and three-months; Barthel index at three-months; and Mini Mental State Examination at 10 days and

  5. Pycnogenol efficiency on glycaemia, motor nerve conduction velocity and markers of oxidative stress in mild type diabetes in rats.

    PubMed

    Jankyova, S; Kucera, P; Goldenberg, Z; Yaghi, D; Navarova, J; Kyselova, Z; Stolc, S; Klimas, J; Racanska, E; Matyas, S

    2009-08-01

    The aim of this study was to describe the effects of Pycnogenol at various doses on preprandial and postprandial glucose levels, the levels of thiobarbituric acid reactive substances (TBARs) and N-acetyl-beta-d-glucosaminidase (NAGA) and on motor nerve conduction velocity (MNCV) in streptozotocin (STZ)-induced diabetic rats. Pycnogenol treatment (10, 20, 50 mg/kg body weight (b.w.)/day) lasted for 8 weeks after induction of diabetes. Pycnogenol significantly decreased elevated levels of preprandial glycaemia in treated animals at all doses. At doses of 10 mg/kg b.w./day and 20 mg/kg b.w./day it significantly decreased elevated levels of postprandial glycaemia compared with diabetic non-treated animals. Pycnogenol failed to induce a significant decrease of postprandial glycaemia at a dose of 50 mg/kg b.w./day. Pycnogenol improved significantly the impaired MNCV at doses of 10 and 20 mg/kg b.w./day compared with non-treated animals. The levels of TBARs were elevated in diabetic rats. The levels of NAGA increased gradually despite the treatment. Pycnogenol failed to affect the increased levels of TBARs and NAGA. Pycnogenollowered the elevated levels of glycaemia and reduced the decline in motor nerve conduction velocity in STZ-induced diabetic rats. The effect of Pycnogenol on postprandial glycaemic levels and MNCV was not dose-dependent.

  6. Systematic review of descriptive cohort studies on the dynamics of glycaemia among adults admitted to hospital with acute stroke.

    PubMed

    Laird, Elizabeth A; Coates, Vivien; Chaney, David

    2013-03-01

    This article presents the results of a systematic review of descriptive cohort studies on the dynamics of glycaemia among adults admitted to hospital with acute stroke. Hyperglycaemia is common among adults admitted to hospital with stroke. Systematic review. A search for descriptive cohort studies published between January 1996-June 2011, was conducted in MEDLINE, PubMed and Embase electronic databases. The search was performed using the terms 'stroke', 'hyperglycaemia' and/or 'glucose' combined and limited to adults and English language publications. Searching of citations from identified studies supplemented the electronic searches. A systematic review was conducted of eight studies, meeting the criteria of: (1) descriptive cohort studies; (2) adults admitted to hospital with acute stroke; and (3) glycaemic status monitored over at least two consecutive days from admission to hospital. The review adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis standards. The dynamics of glycaemia after stroke has been investigated in seven prospective cohort studies and one retrospective study. The patterns that emerged were persisting normoglycaemia, transient hyperglycaemia, persisting hyperglycaemia and delayed hyperglycaemia. Surges in glycaemia are likely on days 2 and 3 and some adults will not exhibit hyperglycaemia till day 7. Further large cohort studies are required to explore the dynamic of glycaemia after stroke for at least 1 week duration. The timing of formal screening for diabetes mellitus is important, as early screening may overestimate detection rates. © 2012 Blackwell Publishing Ltd.

  7. Genotype-phenotype characteristics and baseline natural history of heritable neuropathies caused by mutations in the MPZ gene.

    PubMed

    Sanmaneechai, Oranee; Feely, Shawna; Scherer, Steven S; Herrmann, David N; Burns, Joshua; Muntoni, Francesco; Li, Jun; Siskind, Carly E; Day, John W; Laura, Matilde; Sumner, Charlotte J; Lloyd, Thomas E; Ramchandren, Sindhu; Shy, Rosemary R; Grider, Tiffany; Bacon, Chelsea; Finkel, Richard S; Yum, Sabrina W; Moroni, Isabella; Piscosquito, Giuseppe; Pareyson, Davide; Reilly, Mary M; Shy, Michael E

    2015-11-01

    We aimed to characterize genotype-phenotype correlations and establish baseline clinical data for peripheral neuropathies caused by mutations in the myelin protein zero (MPZ) gene. MPZ mutations are the second leading cause of Charcot-Marie-Tooth disease type 1. Recent research makes clinical trials for patients with MPZ mutations a realistic possibility. However, the clinical severity varies with different mutations and natural history data on progression is sparse. We present cross-sectional data to begin to define the phenotypic spectrum and clinical baseline of patients with these mutations. A cohort of patients with MPZ gene mutations was identified in 13 centres of the Inherited Neuropathies Consortium - Rare Disease Clinical Research Consortium (INC-RDCRC) between 2009 and 2012 and at Wayne State University between 1996 and 2009. Patient phenotypes were quantified by the Charcot-Marie-Tooth disease neuropathy score version 1 or 2 and the Charcot-Marie-Tooth disease paediatric scale outcome instruments. Genetic testing was performed in all patients and/or in first- or second-degree relatives to document mutation in MPZ gene indicating diagnosis of Charcot-Marie-Tooth disease type 1B. There were 103 patients from 71 families with 47 different MPZ mutations with a mean age of 40 years (range 3-84 years). Patients and mutations were separated into infantile, childhood and adult-onset groups. The infantile onset group had higher Charcot-Marie-Tooth disease neuropathy score version 1 or 2 and slower nerve conductions than the other groups, and severity increased with age. Twenty-three patients had no family history of Charcot-Marie-Tooth disease. Sixty-one patients wore foot/ankle orthoses, 19 required walking assistance or support, and 10 required wheelchairs. There was hearing loss in 21 and scoliosis in 17. Forty-two patients did not begin walking until after 15 months of age. Half of the infantile onset patients then required ambulation aids or wheelchairs for

  8. Genotype–phenotype characteristics and baseline natural history of heritable neuropathies caused by mutations in the MPZ gene

    PubMed Central

    Feely, Shawna; Scherer, Steven S.; Herrmann, David N.; Burns, Joshua; Muntoni, Francesco; Li, Jun; Siskind, Carly E.; Day, John W.; Laura, Matilde; Sumner, Charlotte J.; Lloyd, Thomas E.; Ramchandren, Sindhu; Shy, Rosemary R.; Grider, Tiffany; Bacon, Chelsea; Finkel, Richard S.; Yum, Sabrina W.; Moroni, Isabella; Piscosquito, Giuseppe; Pareyson, Davide; Reilly, Mary M.; Shy, Michael E.

    2015-01-01

    We aimed to characterize genotype–phenotype correlations and establish baseline clinical data for peripheral neuropathies caused by mutations in the myelin protein zero (MPZ) gene. MPZ mutations are the second leading cause of Charcot–Marie–Tooth disease type 1. Recent research makes clinical trials for patients with MPZ mutations a realistic possibility. However, the clinical severity varies with different mutations and natural history data on progression is sparse. We present cross-sectional data to begin to define the phenotypic spectrum and clinical baseline of patients with these mutations. A cohort of patients with MPZ gene mutations was identified in 13 centres of the Inherited Neuropathies Consortium - Rare Disease Clinical Research Consortium (INC-RDCRC) between 2009 and 2012 and at Wayne State University between 1996 and 2009. Patient phenotypes were quantified by the Charcot–Marie–Tooth disease neuropathy score version 1 or 2 and the Charcot–Marie–Tooth disease paediatric scale outcome instruments. Genetic testing was performed in all patients and/or in first- or second-degree relatives to document mutation in MPZ gene indicating diagnosis of Charcot–Marie–Tooth disease type 1B. There were 103 patients from 71 families with 47 different MPZ mutations with a mean age of 40 years (range 3–84 years). Patients and mutations were separated into infantile, childhood and adult-onset groups. The infantile onset group had higher Charcot–Marie–Tooth disease neuropathy score version 1 or 2 and slower nerve conductions than the other groups, and severity increased with age. Twenty-three patients had no family history of Charcot–Marie–Tooth disease. Sixty-one patients wore foot/ankle orthoses, 19 required walking assistance or support, and 10 required wheelchairs. There was hearing loss in 21 and scoliosis in 17. Forty-two patients did not begin walking until after 15 months of age. Half of the infantile onset patients then required

  9. Operating and environmental characteristics of Sigma Tau hydrogen masers used in the Very Long Baseline Array (VLBA)

    NASA Technical Reports Server (NTRS)

    Tucker, T. K.

    1989-01-01

    Presented here are the results obtained from performance evaluation of a pair of Sigma Tau Standards Corporation Model VLBA-112 active hydrogen maser frequency standards. These masers were manufactured for the National Radio Astronomy Observatory (NRAO) for use on the Very Long Baseline Array (VLBA) project and were furnished to the Jet Propulsion Laboratory (JPL) for the purpose of these tests. Tests on the two masers were performed in the JPL Frequency Standards Laboratory (FSL) and included the characterization of output frequency stability versus environmental factors such as temperature, humidity, magnetic field, and barometric pressure. The performance tests also included the determination of phase noise and Allan variance using both FSL and Sigma Tau masers as references. All tests were conducted under controlled laboratory conditions, with only the desired environmental and operational parameters varied to determine sensitivity to external environment.

  10. Healthy Immigrant Families: Participatory Development and Baseline Characteristics of a Community-Based Physical Activity and Nutrition Intervention

    PubMed Central

    Wieland, Mark L.; Weis, Jennifer A.; Hanza, Marcelo M.K.; Meiers, Sonja J.; Patten, Christi A.; Clark, Matthew M.; Sloan, Jeff A.; Novotny, Paul J.; Njeru, Jane W.; Abbenyi, Adeline; Levine, James A.; Goodson, Miriam; Capetillo, Maria Graciela D. Porraz; Osman, Ahmed; Hared, Abdullah; Nigon, Julie A.; Sia, Irene G.

    2015-01-01

    Background US immigrants often have escalating cardiovascular risk. Barriers to optimal physical activity and diet have a significant role in this risk accumulation. Methods We developed a physical activity and nutrition intervention with immigrant and refugee families through a community-based participatory research approach. Work groups of community members and health scientists developed an intervention manual with 12 content modules that were based on social-learning theory. Family health promoters from the participating communities (Hispanic, Somali, Sudanese) were trained to deliver the intervention through 12 home visits during the first 6 months and up to 12 phone calls during the second 6 months. The intervention was tested through a randomized community-based trial with a delayed-intervention control group, with measurements at baseline, 6, 12, and 24 months. Primary measurements included accelerometer-based assessment of physical activity and 24-hour dietary recall. Secondary measures included biometrics and theory-based instruments. Results One hundred fifty-one individuals (81 adolescents, 70 adults; 44 families) were randomized. At baseline, mean (SD) time spent in moderate-to-vigorous physical activity was 64.7 (30.2) minutes/day for adolescents and 43.1 (35.4) minutes/day for adults. Moderate dietary quality was observed in both age groups. Biometric measures showed that 45.7% of adolescents and 80.0% of adults were overweight or obese. Moderate levels of self-efficacy and social support were reported for physical activity and nutrition. Discussion Processes and products from this program are relevant to other communities aiming to reduce cardiovascular risk and negative health behaviors among immigrants and refugees. Trial Registration This trial was registered at Clinicaltrials.gov (NCT01952808). PMID:26655431

  11. A randomized double-blind multi-center trial of hydrogen water for Parkinson's disease: protocol and baseline characteristics.

    PubMed

    Yoritaka, Asako; Abe, Takashi; Ohtsuka, Chigumi; Maeda, Tetsuya; Hirayama, Masaaki; Watanabe, Hirohisa; Saiki, Hidemoto; Oyama, Genko; Fukae, Jiro; Shimo, Yasushi; Hatano, Taku; Kawajiri, Sumihiro; Okuma, Yasuyuki; Machida, Yutaka; Miwa, Hideto; Suzuki, Chikako; Kazama, Asuka; Tomiyama, Masahiko; Kihara, Takeshi; Hirasawa, Motoyuki; Shimura, Hideki; Hattori, Nobutaka

    2016-05-12

    Our previous randomized double-blind study showed that drinking hydrogen (H2) water for 48 weeks significantly improved the total Unified Parkinson's Disease Rating Scale (UPDRS) score of Parkinson's disease (PD) patients treated with levodopa. We aim to confirm this result using a randomized double-blind placebo-controlled multi-center trial. Changes in the total UPDRS scores from baseline to the 8(th), 24(th), 48(th), and 72(nd) weeks, and after the 8(th) week, will be evaluated. The primary endpoint of the efficacy of this treatment in PD is the change in the total UPDRS score from baseline to the 72(nd) week. The changes in UPDRS part II, UPDRS part III, each UPDRS score, PD Questionnaire-39 (PDQ-39), and the modified Hoehn and Yahr stage at these same time-points, as well as the duration until the protocol is finished because additional levodopa is required or until the disease progresses, will also be analyzed. Adverse events and screening laboratory studies will also be examined. Participants in the hydrogen water group will drink 1000 mL/day of H2 water, and those in the placebo water group will drink normal water. One-hundred-and-seventy-eight participants with PD (89 women, 89 men; mean age: 64.2 [SD 9.2] years, total UPDRS: 23.7 [11.8], with levodopa medication: 154 participants, without levodopa medication: 24 participants; daily levodopa dose: 344.1 [202.8] mg, total levodopa equivalent dose: 592.0 [317.6] mg) were enrolled in 14 hospitals and were randomized. This study will confirm whether H2 water can improve PD symptoms. UMIN000010014 (February, 13, 2013).

  12. Baseline characteristics of European and non-European adult patients with attention deficit hyperactivity disorder participating in a placebo-controlled, randomized treatment study with atomoxetine

    PubMed Central

    2013-01-01

    Background Attention deficit/hyperactivity disorder (ADHD) often presents as an impairing lifelong condition in adults; yet it is currently underdiagnosed and undertreated in many European countries. This analysis examines the characteristics of adult patients with ADHD in a European (EUR) and non-European (NE) patient population. Methods Baseline data from the open-label treatment period of a randomized trial of atomoxetine in adult patients with ADHD (N=2017; EUR, n=1217; NE, n=800) were examined. All patients who were enrolled were included in the baseline analyses. Results The demographics for patients in the EUR and NE groups were comparable. Patients in the EUR group had a somewhat lower percentage of prior exposure to psychostimulants compared with the NE group (32.7% vs. 38.9%, p=.0049). Scores on the Conners’ Adult ADHD Rating Scale-Investigator Rated: Screening Version with adult ADHD prompts (18-item total, inattentive and hyperactive/impulsive subscales, and index) were comparable. The adult ADHD Quality of Life-Life Outlook and Life Productivity domain scores were significantly different between groups (p≤.0004). The EuroQol-5 Dimension United Kingdom and United States population-based index scores and Health State score were comparable between groups. Conclusions Adults with ADHD in Europe present similar demographics and baseline characteristics to those outside Europe and hence, study results outside Europe may be generalizable to patients in Europe. Trial registration Clinicaltrials.gov, NCT00700427 PMID:23648011

  13. The baseline characteristics of parents and African American girls in an online obesity prevention program: A feasibility study

    USDA-ARS?s Scientific Manuscript database

    The objective of this paper was to identify the relationships and associations between child and parent characteristics with child fruit and vegetable (FV) consumption in an online obesity prevention program for 8-10 year old African American girls. Girls and a parent (n=342 child-parent pairs) in t...

  14. Do various baseline characteristics of transversus abdominis and lumbar multifidus predict clinical outcomes in nonspecific low back pain? A systematic review.

    PubMed

    Wong, Arnold Y L; Parent, Eric C; Funabashi, Martha; Stanton, Tasha R; Kawchuk, Gregory N

    2013-12-01

    Although individual reports suggest that baseline morphometry or activity of transversus abdominis or lumbar multifidus predict clinical outcome of low back pain (LBP), a related systematic review is unavailable. Therefore, this review summarized evidence regarding the predictive value of these muscular characteristics. Candidate publications were identified from 6 electronic medical databases. After review, 5 cohort studies were included. Although this review intended to encompass studies using different muscle assessment methods, all included studies coincidentally used ultrasound imaging. No research investigated the relation between static morphometry and clinical outcomes. Evidence synthesis showed limited evidence supporting poor baseline transversus abdominis contraction thickness ratio as a treatment effect modifier favoring motor control exercise. Limited evidence supported that high baseline transversus abdominis lateral slide was associated with higher pain intensity after various exercise interventions at 1-year follow-up. However, there was limited evidence for the absence of relation between the contraction thickness ratio of transversus abdominis or anticipatory onset of lateral abdominal muscles at baseline and the short- or long-term LBP intensity after exercise interventions. There was conflicting evidence for a relation between baseline percent thickness change of lumbar multifidus during contraction and the clinical outcomes of patients after various conservative treatments. Given study heterogeneity, the small number of included studies and the inability of conventional greyscale B-mode ultrasound imaging to measure muscle activity, our findings should be interpreted with caution. Further large-scale prospective studies that use appropriate technology (ie, electromyography to assess muscle activity) should be conducted to investigate the predictive value of morphometry or activity of these muscles with respect to LBP-related outcomes measures

  15. Stanford GEMS Phase 2 Obesity Prevention Trial for Low-Income African-American Girls: Design and Sample Baseline Characteristics

    PubMed Central

    Robinson, Thomas N.; Kraemer, Helena C.; Matheson, Donna M.; Obarzanek, Eva; Wilson, Darrell M.; Haskell, William L.; Pruitt, Leslie A.; Thompson, Nikko S.; Farish Haydel, K; Fujimoto, Michelle; Varady, Ann; McCarthy, Sally; Watanabe, Connie; Killen, Joel D

    2008-01-01

    Objective African-American girls and women are at high risk of obesity and its associated morbidities. Few studies have tested obesity prevention strategies specifically designed for African-American girls. This report describes the design and baseline findings of the Stanford GEMS (Girls health Enrichment Multi-site Studies) trial to test the effect of a 2-year community- and family-based intervention to reduce weight gain in low-income, preadolescent African-American girls. Design Randomized controlled trial with measurements scheduled in girls’ homes at baseline, 6, 12, 18 and 24 months post randomization. Setting Low-income areas of Oakland, CA. Participants Eight, nine and ten year old African-American girls and their parents/caregivers. Interventions Girls are randomized to a culturally-tailored after school dance program and a home/family-based intervention to reduce screen media use versus an information-based community health education active-placebo comparison intervention. Interventions last for 2-years for each participant. Main Outcome Measure Change in body mass index over the two-year study. Results Recruitment and enrollment successfully produced a predominately low-socioeconomic status sample. 261 families were randomized. One girl per family is randomly chosen for the analysis sample. Randomization produced comparable experimental groups with only a few statistically significant differences. The sample had a mean body mass index (BMI) at the 74th percentile on the 2000 CDC BMI reference, and one-third of the analysis sample had a BMI at the 95th percentile or above. Average fasting total cholesterol and LDL-cholesterol were above NCEP thresholds for borderline high classifications. Girls averaged low levels of moderate to vigorous physical activity, more than 3 hours per day of screen media use, and diets high in energy from fat. Conclusions The Stanford GEMS trial is testing the benefits of culturally-tailored after-school dance and screen time

  16. Stanford GEMS phase 2 obesity prevention trial for low-income African-American girls: design and sample baseline characteristics.

    PubMed

    Robinson, Thomas N; Kraemer, Helena C; Matheson, Donna M; Obarzanek, Eva; Wilson, Darrell M; Haskell, William L; Pruitt, Leslie A; Thompson, Nikko S; Haydel, K Farish; Fujimoto, Michelle; Varady, Ann; McCarthy, Sally; Watanabe, Connie; Killen, Joel D

    2008-01-01

    African-American girls and women are at high risk of obesity and its associated morbidities. Few studies have tested obesity prevention strategies specifically designed for African-American girls. This report describes the design and baseline findings of the Stanford GEMS (Girls health Enrichment Multi-site Studies) trial to test the effect of a two-year community- and family-based intervention to reduce weight gain in low-income, pre-adolescent African-American girls. Randomized controlled trial with measurements scheduled in girls' homes at baseline, 6, 12, 18 and 24 month post-randomization. Low-income areas of Oakland, CA. Eight, nine and ten year old African-American girls and their parents/caregivers. Girls are randomized to a culturally-tailored after-school dance program and a home/family-based intervention to reduce screen media use versus an information-based community health education Active-Placebo Comparison intervention. Interventions last for 2 years for each participant. Change in body mass index over the two-year study. Recruitment and enrollment successfully produced a predominately low-socioeconomic status sample. Two-hundred sixty one (261) families were randomized. One girl per family is randomly chosen for the analysis sample. Randomization produced comparable experimental groups with only a few statistically significant differences. The sample had a mean body mass index (BMI) at the 74 th percentile on the 2000 CDC BMI reference, and one-third of the analysis sample had a BMI at the 95th percentile or above. Average fasting total cholesterol and LDL cholesterol were above NCEP thresholds for borderline high classifications. Girls averaged low levels of moderate to vigorous physical activity, more than 3 h per day of screen media use, and diets high in energy from fat. The Stanford GEMS trial is testing the benefits of culturally-tailored after-school dance and screen-time reduction interventions for obesity prevention in low-income, pre

  17. Design and baseline characteristics from the KAN-QUIT disease management intervention for rural smokers in primary care.

    PubMed

    Cox, Lisa Sanderson; Cupertino, Ana-Paula; Mussulman, Laura M; Nazir, Niaman; Greiner, K Allen; Mahnken, Jonathan D; Ahluwalia, Jasjit S; Ellerbeck, Edward F

    2008-08-01

    To describe the design, implementation, baseline data, and feasibility of establishing a disease management program for smoking cessation in rural primary care. The study is a randomized clinical trial evaluating a disease management program for smoking cessation. The intervention combined pharmacotherapy, telephone counseling, and physician feedback, and repeated intervention over two years. The program began in 2004 and was implemented in 50 primary care clinics across the State of Kansas. Of eligible patients, 73% were interested in study participation. 750 enrolled participants were predominantly Caucasian, female, employed, and averaged 47.2 years of age (SD=13.1). In addition to smoking, 427 (57%) had at least one additional major risk factor for cardiovascular disease (diabetes, hypertension, high cholesterol, heart disease or stroke). Participants smoked on average 23.7 (SD=10.4) cigarettes per day, were contemplating (61%) or preparing to quit (30%), were highly motivated and confident of their ability to quit smoking, and reported seeing their physicians multiple times in the past twelve months (Median=3.50; Mean=5.48; SD=6.58). Initial findings demonstrate the willingness of patients to enroll in a two-year disease management program to address nicotine dependence, even among patients not ready to make a quit attempt. These findings support the feasibility of identifying and enrolling rural smokers within the primary care setting.

  18. The prevalence of diabetes mellitus and impaired fasting glucose/glycaemia (IFG) in suburban and rural Nepal-the communities--based cross-sectional study during the democratic movements in 1990.

    PubMed

    Sasaki, Haruka; Kawasaki, Terukazu; Ogaki, Tetsuro; Kobayashi, Sigeru; Itoh, Kazue; Yoshimizu, Yutaka; Sharma, Sashi; Acharya, Gopal P

    2005-02-01

    A rising prevalence of Type 2 diabetes and impaired fasting glucose/glycaemia (IFG) was recently reported in the urban areas of Nepal by Singh and Bhattarai [D.L. Singh, M.D. Bhattarai, High prevalence of diabetes and impaired fasting glycaemia in urban Nepal, Diabet. Med. 20 (2003) 170-171] in the first population-based study based on the revised diagnostic criteria of ADA-1997 and WHO-1998. In comparison with our community-based survey done in 1990 in suburban and rural areas of Nepal, the current data show a surprisingly rapid increase in the prevalence of diabetes in the Nepalese population. In our 1990 study, diabetes and IFG, respectively, were present in 1.4 and 2.5% of people > or =20 years old in suburban village (Bhadrakali) compared with 0.3 and 0.7% in a rural village (Kotyang). In a short communication, Singh and Bhattarai found the rates to be 14.6 and 9.1% in urban areas, and 2.5 and 1.3% in rural areas. This phenomena appears to have been influenced more by rapid urbanization and changes in lifestyles after the ongoing democratic movements that have taken place since 1990 in Nepal. Moreover, our new analysis of the data provide baseline features for the planning of health care policy and establishment of medical priorities in modern day Nepal.

  19. Rationale, design, and baseline characteristics of the Canagliflozin Cardiovascular Assessment Study (CANVAS)--a randomized placebo-controlled trial.

    PubMed

    Neal, Bruce; Perkovic, Vlado; de Zeeuw, Dick; Mahaffey, Kenneth W; Fulcher, Greg; Stein, Peter; Desai, Mehul; Shaw, Wayne; Jiang, Joel; Vercruysse, Frank; Meininger, Gary; Matthews, David

    2013-08-01

    Sodium glucose co-transporter 2 inhibition is a novel mode of treatment for type 2 diabetes mellitus (T2DM). The sodium glucose co-transporter 2 inhibitor canagliflozin lowered blood glucose, blood pressure, and body weight, with increased risk of urogenital infections in Phase 2 studies. Effects on macrovascular complications of diabetes remain to be determined. CANVAS is a double-blind, placebo-controlled trial designed to evaluate the effects of canagliflozin on the risk of cardiovascular disease and to assess safety and tolerability in patients with inadequately controlled T2DM and increased cardiovascular risk. The first of 2 planned phases randomized 4,330 individuals to placebo, canagliflozin 100 or 300 mg (1:1:1) with planned follow-up of about 2 years to substantiate potential cardiovascular protection by assessing key biomarkers and to achieve initial safety objectives. By the end of mid-September 2012, a total of 7174 patient-years of follow-up were accrued. Mean baseline age was 62 years, duration of diabetes 13 years; hemoglobin A1c 8.2%, fasting plasma glucose 9.3 mmol/L, and body mass index 32 kg/m(2). Of the participants, 34% are female and 57% had a history of atherosclerotic vascular disease. Participants will be followed up to achieve primary safety and tolerability objectives and to investigate secondary outcomes. The planned second phase will not be undertaken. CANVAS will define the effects of canagliflozin on biomarkers and provide data on cardiovascular safety against established regulatory parameters.

  20. Rationale, Design and Baseline Characteristics of Participants in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) Trial.

    PubMed

    Bosch, Jackie; Eikelboom, John W; Connolly, Stuart J; Bruns, Nancy Cook; Lanius, Vivian; Yuan, Fei; Misselwitz, Frank; Chen, Edmond; Diaz, Rafael; Alings, Marco; Lonn, Eva M; Widimsky, Petr; Hori, Masatsugu; Avezum, Alvaro; Piegas, Leopoldo S; Bhatt, Deepak L; Branch, Kelley R H; Probstfield, Jeffrey L; Liang, Yan; Liu, Lisheng; Zhu, Jun; Maggioni, Aldo P; Lopez-Jaramillo, Patricio; O'Donnell, Martin; Fox, Keith A A; Kakkar, Ajay; Parkhomenko, Alexander N; Ertl, Georg; Störk, Stefan; Keltai, Katalin; Keltai, Matyas; Ryden, Lars; Dagenais, Gilles R; Pogosova, Nana; Dans, Antonio L; Lanas, Fernando; Commerford, Patrick J; Torp-Pedersen, Christian; Guzik, Tomasz J; Verhamme, Peter B; Vinereanu, Dragos; Kim, Jae-Hyung; Ha, Jong-Won; Tonkin, Andrew M; Varigos, John D; Lewis, Basil S; Felix, Camilo; Yusoff, Khalid; Steg, Philippe Gabriel; Aboyans, Victor; Metsarinne, Kaj P; Anand, Sonia S; Hart, Robert G; Lamy, Andre; Moayyedi, Paul; Leong, Darryl P; Sharma, Mukul; Yusuf, Salim

    2017-08-01

    Long-term aspirin prevents vascular events but is only modestly effective. Rivaroxaban alone or in combination with aspirin might be more effective than aspirin alone for vascular prevention in patients with stable coronary artery disease (CAD) or peripheral artery disease (PAD). Rivaroxaban as well as aspirin increase upper gastrointestinal (GI) bleeding and this might be prevented by proton pump inhibitor therapy. Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) is a double-blind superiority trial comparing rivaroxaban 2.5 mg twice daily combined with aspirin 100 mg once daily or rivaroxaban 5 mg twice daily vs aspirin 100 mg once daily for prevention of myocardial infarction, stroke, or cardiovascular death in patients with stable CAD or PAD. Patients not taking a proton pump inhibitor were also randomized, using a partial factorial design, to pantoprazole 40 mg once daily or placebo. The trial was designed to have at least 90% power to detect a 20% reduction in each of the rivaroxaban treatment arms compared with aspirin and to detect a 50% reduction in upper GI complications with pantoprazole compared with placebo. Between February 2013 and May 2016, we recruited 27,395 participants from 602 centres in 33 countries; 17,598 participants were included in the pantoprazole vs placebo comparison. At baseline, the mean age was 68.2 years, 22.0% were female, 90.6% had CAD, and 27.3% had PAD. COMPASS will provide information on the efficacy and safety of rivaroxaban, alone or in combination with aspirin, in the long-term management of patients with stable CAD or PAD, and on the efficacy and safety of pantoprazole in preventing upper GI complications in patients receiving antithrombotic therapy. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  1. [Baseline characteristics and changes in treatment after a period of optimization of the patients included in the study EFICAR].

    PubMed

    Gómez-Marcos, Manuel A; Agudo-Conde, Cristina; Torcal, Jesús; Echevarria, Pilar; Domingo, Mar; Arietaleanizbeascoa, María; Sanz-Guinea, Aitor; de la Torre, Maria M; Ramírez, Jose I; García-Ortiz, Luis

    2016-03-01

    To describe the baseline date and drugs therapy changes during treatment optimization in patients with heart failure with depressed systolic function included in the EFICAR study. Multicenter randomized clinical trial. Seven Health Centers. 150 patients (ICFSD) age 68±10 years, 77% male. Sociodemographic variables, comorbidities (Charlson index), functional capacity and quality of life. Drug therapy optimization was performed. The main etiology was ischemic heart disease (45%), with 89% in functional class II. The Charlson index was 2.03±1.05. The ejection fraction mean was 37%±8, 19% with ejection fraction <30%. With the stress test 6.3±1.6 mean was reached, with the 6 minutes test 446±78 meters and the chair test 13.7±4.4 seconds. The overall quality of life with ejection fraction was 22.8±18.7 and with the Short Form-36 Health Survey, physical health 43.3±8.4 and mental health 50.1±10.6. After optimizing the treatment, the percentage of patients on drugs therapy and the dose of angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists and beta-blockers were not changed. The majority of the subjects are in functional class II, with functional capacity and quality of life decreased and comorbidity index high. A protocolized drug therapy adjustment did not increase the dose or number of patients with effective drugs for heart failure with depressed systolic function. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

  2. Arrhythmia and Sudden Death in Hemodialysis Patients: Protocol and Baseline Characteristics of the Monitoring in Dialysis Study.

    PubMed

    Charytan, David M; Foley, Robert; McCullough, Peter A; Rogers, John D; Zimetbaum, Peter; Herzog, Charles A; Tumlin, James A

    2016-04-07

    Dialysis patients have high rates of cardiovascular morbidity and mortality, but data on arrhythmia burden, arrhythmia type, arrhythmia triggers, and the identity of terminal arrhythmias have historically been limited by an inability to monitor heart rhythm for prolonged periods. To investigate arrhythmia and its association with sudden death in dialysis-dependent ESRD, describe the potential for implantable devices to advance study of dialysis physiology, review the ethical implications of using implantable devices in clinical studies, and report on the protocol and baseline results of the Monitoring in Dialysis Study (MiD). In this multicenter, interventional-observational, prospective cohort study, we placed implantable loop recorders in patients undergoing long-term hemodialysis. The proportion of patients experiencing clinically significant arrhythmias was the primary endpoint. For 6 months, we captured detailed data on the primary endpoint, symptomatic arrhythmias, other electrocardiographic variables, dialysis prescription, electrolytes, dialysis-related variables, and vital signs. We collected additional electrocardiographic data for up to 1 year. Overall, 66 patients underwent implantation in sites in the United States and India. Diabetes was present in 63.6% of patients, 12.1% were age ≥70 years, 69.7% were men, and 53.0% were black. Primary and secondary endpoint data are expected in 2016. Cardiac arrhythmia is an important contributor to cardiovascular morbidity and mortality in dialysis patients, but available technology has previously limited the ability to estimate its true burden and triggers and to define terminal rhythms in sudden death. Use of implantable technology in observational studies raises complex issues but may greatly expand understanding of dialysis physiology. The use of implantable loop recorders in MiD is among the first examples of such a trial, and the results are expected to provide novel insights into the nature of arrhythmia

  3. Arrhythmia and Sudden Death in Hemodialysis Patients: Protocol and Baseline Characteristics of the Monitoring in Dialysis Study

    PubMed Central

    Foley, Robert; McCullough, Peter A.; Rogers, John D.; Zimetbaum, Peter; Herzog, Charles A.; Tumlin, James A.

    2016-01-01

    Background Dialysis patients have high rates of cardiovascular morbidity and mortality, but data on arrhythmia burden, arrhythmia type, arrhythmia triggers, and the identity of terminal arrhythmias have historically been limited by an inability to monitor heart rhythm for prolonged periods. Objectives To investigate arrhythmia and its association with sudden death in dialysis-dependent ESRD, describe the potential for implantable devices to advance study of dialysis physiology, review the ethical implications of using implantable devices in clinical studies, and report on the protocol and baseline results of the Monitoring in Dialysis Study (MiD). Design, setting, participants, & measurements In this multicenter, interventional-observational, prospective cohort study, we placed implantable loop recorders in patients undergoing long-term hemodialysis. The proportion of patients experiencing clinically significant arrhythmias was the primary endpoint. For 6 months, we captured detailed data on the primary endpoint, symptomatic arrhythmias, other electrocardiographic variables, dialysis prescription, electrolytes, dialysis-related variables, and vital signs. We collected additional electrocardiographic data for up to 1 year. Results Overall, 66 patients underwent implantation in sites in the United States and India. Diabetes was present in 63.6% of patients, 12.1% were age ≥70 years, 69.7% were men, and 53.0% were black. Primary and secondary endpoint data are expected in 2016. Conclusions Cardiac arrhythmia is an important contributor to cardiovascular morbidity and mortality in dialysis patients, but available technology has previously limited the ability to estimate its true burden and triggers and to define terminal rhythms in sudden death. Use of implantable technology in observational studies raises complex issues but may greatly expand understanding of dialysis physiology. The use of implantable loop recorders in MiD is among the first examples of such a

  4. Prevention of ischemic events in patients with peripheral arterial disease design, baseline characteristics and 2-year results an observational study.

    PubMed

    Blinc, A; Kozak, M; Sabovic, M; Božic, M; Stegnar, M; Poredoš, P; Kravos, A; Barbic-Žagar, B; Pohar Perme, M; Stare, J

    2011-12-01

    Peripheral arterial disease (PAD) is associated with frequent cardiovascular ischemic events. We followed the survival of PAD patients and tested whether PAD remains an adverse prognostic indicator in spite of treatment according to the current European guidelines on cardiovascular disease prevention. Eight hundred eleven patients with PAD and 778 control subjects, aged 65 (SD 9) years at inclusion, with a male/female ratio of 3/2 were treated according to the European guidelines on cardiovascular disease prevention and evaluated yearly for occurrence of death, non-fatal acute coronary syndrome, stroke or critical limb ischemia (major events) and revascularization procedures (minor events). At baseline, classical risk factors were significantly more prevalent in the PAD group and protective cardiovascular medication was prescribed to patients with PAD more frequently than to control subjects. In the PAD group, the 2-year Kaplan-Meier survival estimate was 96.7% (CI 95.4-97.9) vs. 98.2% (CI 97.2-99.1) in the control group, P=0.059. The groups differed in the 2-year major event-free survival: 93.5% (CI 92.7-95.3) in PAD vs. 97.1% (CI 95.9-98.4) in controls, P<0.017, as well as in event-free survival: 79.9% (CI 77.1-82.9) in PAD vs.96.4% (CI 95.0-97.9) in controls, P<0.001. Patients with PAD had a borderline higher risk of all-cause death and a significantly higher risk of major and minor non-fatal cardiovascular events compared to control subjects. However, treatment according to the European guidelines on cardiovascular disease prevention resulted in encouragingly low absolute mortality and morbidity. (ClinicalTrials.gov number NCT00761969.).

  5. Glycaemia control and the risk of hospitalisation for infection in patients with type 2 diabetes: Hong Kong Diabetes Registry.

    PubMed

    Luk, Andrea O Y; Lau, Eric S H; Cheung, Kitty K T; Kong, Alice P S; Ma, Ronald C W; Ozaki, Risa; Chow, Francis C C; So, Wing-Yee; Chan, Juliana C N

    2017-07-21

    Infection occurs more commonly in diabetic patients compared with the general population and is an under-recognised but important morbidity in patients with diabetes. We examined the impact of glycaemic control on hospitalisation for infection in a large prospective cohort of Chinese adults with type 2 diabetes. Between July 1994 and June 2014, 22 846 patients with type 2 diabetes underwent detailed assessment of metabolic control and diabetes complications. Patients were followed for occurrence of infection requiring hospitalisation as identified using discharge diagnosis codes. Over a median follow-up of 4.8 years, 20.3% of patients were hospitalised for any infection type, with respiratory tract, genitourinary tract, and skin being the most commonly affected sites. In multivariate Cox regression, time-dependent HbA1c was associated with all-site infection (hazard ratio [HR] 1.07 [95% confidence interval {CI}:1.05-1.09, P < 0.001]), genitourinary tract infection (HR 1.09 [95% CI: 1.04-1.14], P < 0.001), and skin infection (HR 1.16 [95% CI 1.12-1.21]. P < 0.001), but not infection of respiratory tract, and was independent of age, gender, disease duration, smoking, body mass index, glomerular filtration rate, haemoglobin, history of stroke, congestive heart failure, coronary heart disease, peripheral artery disease, diabetic neuropathy and cancer, and baseline drug use. Against an arbitrary HbA1c interval of >7.0-8.0% (53-64 mmol/mol), patients with HbA1c ≤6.0% (42 mmol/mol) and >8.0% (64 mmol/mol) had excess risks of infection-related hospitalisation adjusted for other factors. In patients with type 2 diabetes, burden of serious infection is high. In the diabetic population, a U-shape relationship between glycaemia and infection-related hospitalisation was detected. Copyright © 2017 John Wiley & Sons, Ltd.

  6. The Pregnancy in Polycystic Ovary Syndrome Study II: Baseline Characteristics and Effects of Obesity from a Multi-Center Randomized Clinical Trial

    PubMed Central

    Legro, Richard S.; Brzyski, Robert G.; Diamond, Michael P.; Coutifaris, Christos; Schlaff, William D.; Alvero, Ruben; Casson, Peter; Christman, Gregory M.; Huang, Hao; Yan, Qingshang; Haisenleder, Daniel J.; Barnhart, Kurt T.; Bates, G. Wright; Usadi, Rebecca; Lucidi, Richard; Baker, Valerie; Trussell, J.C.; Krawetz, Stephen A.; Snyder, Peter; Ohl, Dana; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping

    2014-01-01

    Objective To summarize baseline characteristics from a large multi-center infertility clinical trial. Design Cross-sectional baseline data from a double-blind randomized trial of 2 treatment regimens (letrozole vs. clomiphene). Setting Academic Health Centers throughout the U.S. Interventions None Main Outcome Measure(s) Historical, biometric, biochemical and questionnaire parameters. Participants 750 women with PCOS and their male partners took part in the study. Results Females averaged ~30 years old and were obese (BMI 35) with ~20% from a racial/ethnic minority. Most (87%) were hirsute and nulligravid (63%). . Most of the females had an elevated antral follicle count and enlarged ovarian volume on ultrasound. Women had elevated mean circulating androgens, LH:FSH ratio (~2), and AMH levels (8.0 ng/mL). Additionally, women had evidence for metabolic dysfunction with elevated mean fasting insulin and dyslipidemia. Increasing obesity was associated with decreased LH:FSH levels, AMH levels and antral follicle counts but increasing cardiovascular risk factors, including prevalence of the metabolic syndrome. Males were obese (BMI 30) and had normal mean semen parameters. Conclusions The treatment groups were well-matched at baseline. Obesity exacerbates select female reproductive and most metabolic parameters. We have also established a database and sample repository that will eventually be accessible to investigators. PMID:24156957

  7. Immune-mediated inflammatory diseases and other comorbidities in patients with psoriasis: baseline characteristics of patients in the AQUILES study.

    PubMed

    Vanaclocha, F; Crespo-Erchiga, V; Jiménez-Puya, R; Puig, L; Sánchez-Carazo, J L; Ferrán, M; Sancho, C; Juliá, B; Cea-Calvo, L; Marín-Jiménez, I; García-Vicuña, R

    2015-01-01

    Patients with psoriasis often have comorbidities, including other immune-mediated inflammatory diseases (IMIDs), and cardiovascular risk factors. In this article we describe the baseline prevalence of comorbidities-including other IMIDs-in a cohort of patients with psoriasis. AQUILES was a prospective observational multicenter study of 3 patient cohorts (patients with psoriasis, spondyloarthritis, or inflammatory bowel disease) undertaken to investigate the prevalence of comorbidities, including other IMIDs, in these settings. The psoriasis cohort comprised patients aged at least 18 years who were seen in hospital dermatology clinics. A predefined protocol was used to collect demographic and clinical data. The study enrolled 528 patients with psoriasis (60.2% men and 39.8% women). Mean age was 46.7 years; 89.8% of the participants had plaque psoriasis, and the median Psoriasis Area Severity Index score (PASI) was 3.2 (1.5-7.4). Comorbid IMIDs were present in 82 (15.5%) of the patients (CI 95%, 12.7%-18.9%). Spondyloarthritis was observed in 14% of patients (95% CI, 11.3%-17.2%), mostly in the form of psoriatic arthritis, for which the overall prevalence was 13.1% (95% CI, 10.5%-16.2%). Inflammatory bowel disease was present in 1.3% (95% CI, 0.6%-2.7%) and uveitis in .2% (95% CI, 0.1%-1.4%). Psoriatic arthritis was associated with male sex (odds ratio, 1.75 [.98-2.98]) and a disease duration of over 8 years (OR, 4.17 [1.84-9.44] vs a duration of < 4 years). In 73.1%, at least 1 cardiovascular risk factor was identified: smoking (40.5%), obesity (26.0%), dyslipidemia (24.8%), hypertension (24.3%), and diabetes mellitus (12.3%). In patients with psoriasis the prevalence of other IMIDs was 15.5%, a level slightly higher than that found in the general population. Nearly three-quarters of these patients had at least 1 cardiovascular risk factor. Copyright © 2014 Elsevier España, S.L.U. and AEDV. All rights reserved.

  8. Baseline characteristics of the randomized cohort from the Look AHEAD (Action for Health in Diabetes) Research Study

    PubMed Central

    2008-01-01

    OBJECTIVE Look AHEAD (Action for Health in Diabetes) Study is a 16-center randomized clinical trial in overweight and obese individuals with type 2 diabetes designed to evaluate the long-term effects (up to 11.5 years) of an intensive weight loss intervention on the time to incidence for major cardiovascular events. RESEARCH DESIGN AND METHODS Eligibility requirements are diagnosis of type 2 diabetes (determined by self-report and verification) in individuals age 45–74 years, BMI >25 kg/m2 (>27 kg/m2 if currently taking insulin). The intensive lifestyle intervention is designed to achieve and maintain weight loss through decreased caloric intake and increased physical activity. The study is designed to provide 90% probability of detecting an 18% difference in major cardiovascular disease event rates in patients randomized to the intensive lifestyle intervention compared to the control group receiving standard diabetes support and education. RESULTS The 5145 participants who were randomized between 2001 and 2004 were 63.3 % white, 15.6% African-American, 13.2% Hispanic, 5.1% American Indian, and 1.0% Asian-American, which closely paralleled the ethnic distribution of diabetes in the NHANES 1999–2000 survey. Their average age at entry was 59 ± 6.8 years (mean ± SD), and 60% were women. There were 31.5% between 45-54 years of age, 51.5% were 55–64, and 17.0% ≥65 years of age. There were 14.6% of participants who were taking insulin at the time of randomization and 14.1 % had a history of cardiovascular disease. More men (21.2%) than women (9.3%) had a history of cardiovascular disease. Few participants (4.4%) were current cigarette smokers compared to 16.2% in the NHANES 1999–2000 survey. Furthermore, 65% of participants had a first-degree relative with diabetes. Overall, BMI averaged 36 ± 5.9 kg/m2 at baseline with 83.6% of the men and 86.0% of women having a BMI >30 kg/m2 and 17.9% of men and 25.4% of women having a BMI > 40 kg/m2. CONCLUSIONS The Look

  9. Design and baseline characteristics of the 10 Small Steps Study: a randomised controlled trial of an intervention to promote healthy behaviour using a lifestyle score and personalised feedback.

    PubMed

    Parekh, Sanjoti; Vandelanotte, Corneel; King, David; Boyle, Frances M

    2012-03-12

    Non-communicable diseases (NCDs) are the leading causes of death globally and are associated with a limited set of common, modifiable health behaviours: tobacco use, physical inactivity, harmful use of alcohol and unhealthy diet. General practice offers an ideal avenue for addressing such health behaviours on a population-wide basis. This paper describes the protocol of a multiple health behaviour change intervention designed for implementation in general practice and summarises the baseline characteristics of its participants. The 10 Small Steps (10SS) study, a randomised controlled trial, involved 4,678 adult general practice patients in Queensland, Australia. Self-reported data were collected to establish the proportion of participants meeting recommended guidelines for ten health behaviours: physical activity, body mass index, alcohol, smoking and six dietary behaviours. Participants were randomised to four groups: contact at baseline only ('single intervention' and corresponding control group) and contact at baseline and 3 months ('dual intervention' and corresponding control group). At each contact the participants received a computer-tailored feedback and one page information sheet according to their allocation to intervention or control groups. Change in the intervention group compared to the control group was assessed at 3 and12 months after baseline data collection.Responses were summed to calculate an individual lifestyle score (the Prudence Score), which ranged from 0 to 10. The baseline response was 56.5% (4678 of 8343 invited participants) and the study sample was primarily female (68.7%) with an average age of 47 years. The mean Prudence Score was 5.8 (95%CI 5.75-5.85). Baseline data from the 10SS study show that nearly all participants engage in some health behaviours but relatively few adhere simultaneously to a core set of dietary and lifestyle behaviours associated with risk of NCDs. Ample scope exists to improve health behaviour to reduce NCDs

  10. Baseline characteristics of the diabetic participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT).

    PubMed

    Barzilay, J I; Jones, C L; Davis, B R; Basile, J N; Goff, D C; Ciocon, J O; Sweeney, M E; Randall, O S

    2001-04-01

    Hypertension (HTN) is a major risk factor for cardiovascular disease (CVD) in the setting of diabetes. There is no consensus on how best to treat hypertension among those with diabetes. Here we describe the characteristics of a cohort of hypertensive adults with diabetes who are part of a large prospective blood pressure study. This study will help clarify the treatment of HTN in the setting of diabetes. The Antihypertensive and Lipid-Lowering high-risk hypertensive participants, ages > or = 55 years, designed to determine whether the incidence of fatal and nonfatal coronary heart disease (CHD) and combined cardiovascular events (fatal and nonfatal CHD, revascularization surgery, angina pectoris, congestive heart failure, and stroke) differs between diuretic (chlorthalidone) treatment and three alternative antihypertensive therapies: a calcium channel blocker (amlodipine), an ACE inhibitor (lisinopril), and an alpha-adrenergic blocker (doxazosin). The planned follow-up is an average of 6 years, to be completed March 2002. There are 15,297 diabetic individuals in the ALLHAT study (36.0% of the entire cohort). Of these individuals, 50.2% are male, 39.4% are African-American, and 17.7% are Hispanic. Demographic and laboratory characteristics of the cohort are similar to those of other studies of the U.S. elderly population with HTN. The sample size has 42 and 93% confidence, treatments for the two study outcomes. The diabetic cohort in ALLHAT wil be able to provide valuable information about the treatment of hypertension in older diabetic patients at risk for incident CVD.

  11. Baseline subject characteristics predictive of compliance with study-mandated prostate biopsy in men at risk of prostate cancer: results from REDUCE.

    PubMed

    Fischer, S; Sun, S; Howard, L E; Moreira, D M; Castro-Santamaria, R; Andriole, G L; Vidal, A C; Freedland, S J

    2016-06-01

    Study compliance is crucial when the study outcome is determined by an invasive procedure, such as prostate biopsy. To investigate predictors of compliance in study-mandated prostate biopsies, we analyzed demographic, clinical and reported lifestyle data from the REDUCE trial. We retrospectively identified 8025 men from REDUCE with at least 2 years of follow-up, and used multivariable logistic regression to test the association between baseline demographic and clinical characteristics and undergoing the study-mandated prostate biopsy at 2 years. We then examined whether missing any of these data was associated with undergoing a biopsy. In REDUCE, 22% of men did not undergo a 2-year biopsy. On multivariable analysis, the non-North American region was predictive of 42-44% increased likelihood of undergoing a 2-year biopsy (P⩽0.001). Being enrolled at a center that enrolled >10 subjects (2nd and 3rd tertile) was associated with a 42-48% increased likelihood of undergoing a 2-year biopsy (P<0.001). In addition, black race predicted 44% lower rate of on-study 2-year biopsy (odds ratio (OR)=0.56; P=0.001). Finally, missing one or more baseline variables was associated with a 32% decreased likelihood of undergoing a 2-year biopsy (OR=0.68; P<0.001). In REDUCE, men outside North America, those at higher volume centers and those with complete baseline data were more likely to undergo study-mandated 2-year biopsies. Given prostate biopsy is becoming increasingly utilized as an endpoint in trials that are often multi-national, regional differences in compliance should be considered when designing future trials. Likewise, efforts are needed to ensure compliance in low-volume centers or among subjects missing baseline data.

  12. Baseline Subject Characteristics Predictive of Compliance with Study-Mandated Prostate Biopsy in Men at Risk of Prostate Cancer: Results from REDUCE

    PubMed Central

    Fischer, Sean; Sun, Stephanie; Howard, Lauren E.; Moreira, Daniel M.; Castro-Santamaria, Ramiro; Andriole, Gerald L.; Vidal, Adriana C.; Freedland, Stephen J.

    2015-01-01

    Introduction Study compliance is crucial when the study outcome is determined by an invasive procedure, such as prostate biopsy. To investigate predictors of compliance in study-mandated prostate biopsies, we analyzed demographic, clinical and reported lifestyle data from the REDUCE trial. Methods We retrospectively identified 8,025 men from REDUCE with at least 2-years of follow-up, and used multivariable logistic regression to test the association between baseline demographic and clinical characteristics and undergoing the study-mandated prostate biopsy at 2 years. We then examined whether missing any of these data was associated with undergoing a biopsy Results In REDUCE, 22% of men did not undergo a 2-year biopsy. On multivariable analysis, non-North American region was predictive of 42-44% increased likelihood of undergoing a 2-year biopsy (p≤0.001). Being enrolled at a center that enrolled >10 subjects (2nd and 3rd tertile) was associated with a 42-48% increased likelihood of undergoing a 2-year biopsy (p<0.001). Additionally, black race predicted 44% lower rate of on-study 2-year biopsy (OR=0.56; p=0.001). Finally, missing one or more baseline variables was associated with a 32% decreased likelihood of undergoing a 2-year biopsy (OR=0.68; p<0.001). Conclusions In REDUCE, men outside North America, those at higher volume centers, and those with complete baseline data were more likely to undergo study mandated 2-year biopsies. Given prostate biopsy is becoming increasingly utilized as an endpoint in trials that are often multi-national, regional differences in compliance should be considered when designing future trials. Likewise, efforts are needed to ensure compliance in low-volume centers or among subjects missing baseline data. PMID:26926927

  13. Baseline Characteristics and Changes in Bone Mineral Density T-Scores of Bulgarian Women with Postmenopausal Osteoporosis Receiving Denosumab in Routine Clinical Practice.

    PubMed

    Boyanov, Mihail; Shinkov, Alexander; Psachoulia, Emi; Intorcia, Michele; Petkova, Reneta

    2017-03-01

    Postmenopausal osteoporosis (PMO) is common among women over 50 years of age and is associated with an increased risk of fracture. Bone-targeted agents, such as denosumab, can reduce fracture risk in patients with PMO. The aim was to describe baseline characteristics and changes in bone mineral density (BMD) T-scores among women with PMO receiving denosumab in Bulgaria. This multicenter chart review included women with PMO receiving denosumab for ≥1 year in Bulgaria (October 2011-August 2013). Participants were required to have a baseline BMD T-score of ≤-2.5 standard deviations (SDs) at one or more skeletal sites. Overall, 222 women were included. The mean (SD) age at denosumab initiation was 64.2 (8.5) years; 26.6% reported a previous osteoporotic fracture and 6.8% a previous hip fracture. Only half of those reporting a previous fracture (49.2%) had received prior osteoporosis therapy. At baseline, mean (SD) BMD T-scores were lumbar spine -3.2 SD (0.6 SD), total hip -2.3 SD (0.8 SD), and femoral neck -2.7 SD (0.7 SD). After 1 year of denosumab treatment, scores increased significantly at all three sites, reaching -2.7 SD (0.6 SD), -2.1 SD (0.9 SD), and -2.4 SD (0.7 SD), respectively (all p < 0.0001 vs. baseline). No serious adverse drug reactions were identified. Denosumab is usually prescribed in women with PMO at high fracture risk. In the patients who were persistent with treatment at 1 year, denosumab was well tolerated and effective at increasing BMD T-scores at several skeletal sites.

  14. Rationale, design, and baseline characteristics of a randomized, placebo-controlled cardiovascular outcome trial of empagliflozin (EMPA-REG OUTCOME™)

    PubMed Central

    2014-01-01

    Background Evidence concerning the importance of glucose lowering in the prevention of cardiovascular (CV) outcomes remains controversial. Given the multi-faceted pathogenesis of atherosclerosis in diabetes, it is likely that any intervention to mitigate this risk must address CV risk factors beyond glycemia alone. The SGLT-2 inhibitor empagliflozin improves glucose control, body weight and blood pressure when used as monotherapy or add-on to other antihyperglycemic agents in patients with type 2 diabetes. The aim of the ongoing EMPA-REG OUTCOME™ trial is to determine the long-term CV safety of empagliflozin, as well as investigating potential benefits on macro-/microvascular outcomes. Methods Patients who were drug-naïve (HbA1c ≥7.0% and ≤9.0%), or on background glucose-lowering therapy (HbA1c ≥7.0% and ≤10.0%), and were at high risk of CV events, were randomized (1:1:1) and treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo (double blind, double dummy) superimposed upon the standard of care. The primary outcome is time to first occurrence of CV death, non-fatal myocardial infarction, or non-fatal stroke. CV events will be prospectively adjudicated by an independent Clinical Events Committee. The trial will continue until ≥691 confirmed primary outcome events have occurred, providing a power of 90% to yield an upper limit of the adjusted 95% CI for a hazard ratio of <1.3 with a one-sided α of 0.025, assuming equal risks between placebo and empagliflozin (both doses pooled). Hierarchical testing for superiority will follow for the primary outcome and key secondary outcomes (time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina pectoris) where non-inferiority is achieved. Results Between Sept 2010 and April 2013, 592 clinical sites randomized and treated 7034 patients (41% from Europe, 20% from North America, and 19% from Asia). At baseline, the mean age was 63

  15. Potential Effects of a Scenario Earthquake on the Economy of Southern California: Baseline County-Level Migration Characteristics and Trends 1995-2000 and 2001-2010

    USGS Publications Warehouse

    Sherrouse, Benson C.; Hester, David J.

    2008-01-01

    The Multi-Hazards Demonstration Project (MHDP) is a collaboration between the U.S. Geological Survey (USGS) and various partners from the public and private sectors and academia, meant to improve Southern California's resiliency to natural hazards. In support of the MHDP objectives, the ShakeOut Scenario was developed. It describes a magnitude 7.8 earthquake along the southernmost 300 kilometers (200 miles) of the San Andreas Fault, identified by geoscientists as a plausible event that will cause moderate to strong shaking over much of the eight-county (Imperial, Kern, Los Angeles, Orange, Riverside, San Bernardino, San Diego, and Ventura) Southern California region. This report uses historical, estimated, and projected population data from several Federal and State data sources to estimate baseline characteristics and trends of the region's population migration (that is, changes in a person's place of residence over time). The analysis characterizes migration by various demographic, economic, family, and household variables for the period 1995-2000. It also uses existing estimates (beginning in 2001) of the three components of population change - births, deaths, and migration - to extrapolate near-term projections of county-level migration trends through 2010. The 2010 date was chosen to provide baseline projections corresponding to a two-year recovery period following the November 2008 date that was selected for the occurrence of the ShakeOut Scenario earthquake. The baseline characteristics and projections shall assist with evaluating the effects of inflow and outflow migration trends for alternative futures in which the simulated M7.8 earthquake either does or does not occur and the impact of the event on housing and jobs, as well as community composition and regional economy changes based on dispersion of intellectual, physical, economic, and cultural capital.

  16. Baseline Characteristics and Follow up in Patients with Normal Hemodynamics vs. Borderline Mean Pulmonary Arterial Pressure in Systemic Sclerosis — Results from the PHAROS Registry

    PubMed Central

    Bae, Sangmee; Saggar, Rajeev; Bolster, Marcy B.; Chung, Lorinda; Csuka, M. E.; Derk, Chris; Domsic, Robyn; Fischer, Aryeh; Frech, Tracy; Goldberg, Avram; Hinchcliff, Monique; Hsu, Vivien; Hummers, Laura; Schiopu, Elena; Mayes, Maureen D.; McLaughlin, Vallerie; Molitor, Jerry; Naz, Nausheen; Furst, Daniel E.; Maranian, Paul; Steen, Virginia; Khanna, Dinesh

    2012-01-01

    Background Patients with normal (mean pulmonary arterial pressure ≤20 mmHg) and borderline mean pulmonary pressures (mPAP) (boPAP; 21–24 mmHg) are “at risk” of developing pulmonary hypertension(PH). The objectives of this analysis were 1)to examine the baseline characteristics in systemic sclerosis(SSc) with Normal and boPAP, and 2) to explore long term outcomes in SSc patients with boPAP vs. Normal hemodynamics. Methods PHAROS is a multicenter prospective longitudinal cohort of patients with SSc “at risk” or recently diagnosed with resting PH on right heart catheterization (RHC). Baseline clinical characteristics, pulmonary function tests, high resolution computed tomography(HRCT), 2-D echocardiogram, and RHC results were analyzed in Normal and boPAP groups. Results A total of 206 patients underwent RHC (35 Normal, 28 boPAP, 143 had resting PH). There were no differences in the baseline demographics. Patients in the boPAP group were more likely to have restrictive lung disease (67% vs. 30%), fibrosis on HRCT and a higher estimated right ventricular systolic pressure on echocardiogram (46.3 vs. 36.2mmHg; p<0.05) than patients with Normal hemodynamics. RHC revealed higher pulmonary vascular resistance (PVR) and more elevated mPAP on exercise(mPAP ≥30; 88% vs. 56%) in the boPAP group(p<0.05 for both). Patients were followed for a mean of 25.7 months and 24 patients had a repeat RHC during this period. During follow up, 55% of the boPAP group and 32% of the Normal group developed resting PH (p=NS). Conclusions Patients with boPAP have a greater prevalence of abnormal lung physiology, pulmonary fibrosis and presence of exercise mPAP ≥30mmHg. PMID:22307943

  17. The influence of baseline characteristics and disease stage on health-related quality of life in multiple myeloma: findings from six randomized controlled trials.

    PubMed

    Robinson, Don; Esseltine, Dixie-Lee; Regnault, Antoine; Meunier, Juliette; Liu, Kevin; van de Velde, Helgi

    2016-08-01

    This descriptive, cross-sectional analysis evaluated the impact of baseline characteristics on health-related quality of life (HR-QoL) at different stages of multiple myeloma (MM). The bortezomib clinical-trial programme evaluated HR-QoL early and consistently, producing a large multi-study dataset. Baseline data, captured using the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire (QLQ-C30), were pooled from six bortezomib randomized trials conducted in different disease-stage categories: 'New' (previously untreated; n = 753), 'Early' (1-3 prior therapies; n = 1569) and 'Late' (≥4 prior therapies; n = 239) disease. Mean EORTC global health scores were similar across the three stages. Unexpectedly, emotional, physical and role functioning were higher in the later stages, indicating better perceived health. Symptom scores, including pain, were largely similar or lower in the later versus earlier stages, signifying a lower symptom burden/better symptom control with more advanced disease. Notable variation in HR-QoL was observed by age and clinical parameters within and across stages. Multivariate modelling indicated that opioid use and performance status were key factors driving overall HR-QoL across stages. Using an age-restricted analysis, transplant eligibility had little impact on HR-QoL in New disease patients. Thus, changes in HR-QoL over the treatment course of MM are complex and impacted by baseline factors. A prospective observational international inception cohort study that captures key clinical, HR-QoL and demographic characteristics, along with safety and supportive care information, is needed. © 2016 The Authors. British Journal of Haematology Published by John Wiley & Sons Ltd.

  18. The Clinical Research Center for Depression Study: Baseline Characteristics of a Korean Long-Term Hospital-Based Observational Collaborative Prospective Cohort Study

    PubMed Central

    Kim, Tae-Suk; Jeong, Seung Hee; Kim, Jung-Bum; Lee, Min-Soo; Kim, Jae-Min; Yim, Hyeon-Woo

    2011-01-01

    Objective The Clinical Research Center for Depression (CRESCEND) study is a 9-year observational collaborative prospective cohort study for the clinical outcomes in participants with depressive disorders in Korea. In this study, we examined the baseline characteristics of the depressive participants as the hospital-based cohort. Methods Participants were assessed using various instruments including the Clinical Global Impression scale, 17-item Hamilton Depression Rating Scale (HDRS-17), Hamilton Anxiety Rating Scale, Brief Psychiatric Rating Scale, Social and Occupational Functioning Assessment Scale, Beck Depression Inventory-Second Edition, Scale for Suicide Ideation, and World Health Organization Quality of Life assessment instruments-abbreviated version. Also, personal histories of medical and psychiatric illnesses and the range of socio-epidemiologic and clinical data were collected from each participant. Results One thousand one hundred eighty three participants were recruited from 18 hospitals. The mean age of the participants was 47.9±15.9 year-old, 74.4% were female, 82.9% had been diagnosed of major depressive disorder, 40.9% were experiencing their first depressive episode, and 21.4% had a past history of suicide attempts. The majority (85.3%) of the participants were moderately to severely ill. The average HDRS-17 was 19.8±6.1. Significant gender differences at baseline were shown in age, education, marriage, employment, religion, and first depressive episode. Conclusion The baseline findings in the CRESCEND study showed some different characteristics of depression in Korea, suggesting a possibility of ethnic and cultural factors in depression. PMID:21519530

  19. Cohort profile: LifeLines DEEP, a prospective, general population cohort study in the northern Netherlands: study design and baseline characteristics

    PubMed Central

    Tigchelaar, Ettje F; Zhernakova, Alexandra; Dekens, Jackie A M; Hermes, Gerben; Baranska, Agnieszka; Mujagic, Zlatan; Swertz, Morris A; Muñoz, Angélica M; Deelen, Patrick; Cénit, Maria C; Franke, Lude; Scholtens, Salome; Stolk, Ronald P; Wijmenga, Cisca; Feskens, Edith J M

    2015-01-01

    Purpose There is a critical need for population-based prospective cohort studies because they follow individuals before the onset of disease, allowing for studies that can identify biomarkers and disease-modifying effects, and thereby contributing to systems epidemiology. Participants This paper describes the design and baseline characteristics of an intensively examined subpopulation of the LifeLines cohort in the Netherlands. In this unique subcohort, LifeLines DEEP, we included 1539 participants aged 18 years and older. Findings to date We collected additional blood (n=1387), exhaled air (n=1425) and faecal samples (n=1248), and elicited responses to gastrointestinal health questionnaires (n=1176) for analysis of the genome, epigenome, transcriptome, microbiome, metabolome and other biological levels. Here, we provide an overview of the different data layers in LifeLines DEEP and present baseline characteristics of the study population including food intake and quality of life. We also describe how the LifeLines DEEP cohort allows for the detailed investigation of genetic, genomic and metabolic variation for a wide range of phenotypic outcomes. Finally, we examine the determinants of gastrointestinal health, an area of particular interest to us that can be addressed by LifeLines DEEP. Future plans We have established a cohort of which multiple data levels allow for the integrative analysis of populations for translation of this information into biomarkers for disease, and which will offer new insights into disease mechanisms and prevention. PMID:26319774

  20. [Essential thrombocythemia: baseline characteristics and risk factors for survival and thrombosis in a series of 214 patients].

    PubMed

    Angona, Anna; Alvarez-Larrán, Alberto; Bellosillo, Beatriz; Martínez-Avilés, Luz; Garcia-Pallarols, Francesc; Longarón, Raquel; Ancochea, Àgueda; Besses, Carles

    2015-03-15

    Two prognostic models to predict overall survival and thrombosis-free survival have been proposed: International Prognostic Score for Essential Thrombocythemia (IPSET) and IPSET-Thrombosis, respectively, based on age, leukocytes count, history of previous thrombosis, the presence of cardiovascular risk factors and the JAK2 mutational status. The aim of the present study was to assess the clinical and biological characteristics at diagnosis and during evolution in essential thrombocythemia (ET) patients as well as the factors associated with survival and thrombosis and the usefulness of these new prognostic models. We have evaluated the clinical data and the mutation status of JAK2, MPL and calreticulin of 214 ET patients diagnosed in a single center between 1985 and 2012, classified according to classical risk stratification, IPSET and IPSET-Thrombosis. With a median follow-up of 6.9 years, overall survival was not associated with any variable by multivariate analysis. Thrombotic history and leukocytes>10×10(9)/l were associated with thrombosis-free survival (TFS). In our series, IPSET prognostic systems of survival and thrombosis did not provide more clinically relevant information regarding the classic risk of thrombosis stratification. Thrombotic history and leukocytosis>10×10(9)/l were significantly associated with lower TFS, while the prognostic IPSET-Thrombosis system did not provide more information than classical thrombotic risk assessment. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

  1. GFDL's ESM2 global coupled climate-carbon Earth System Models. Part I: physical formulation and baseline simulation characteristics

    USGS Publications Warehouse

    Dunne, John P.; John, Jasmin G.; Adcroft, Alistair J.; Griffies, Stephen M.; Hallberg, Robert W.; Shevalikova, Elena; Stouffer, Ronald J.; Cooke, William; Dunne, Krista A.; Harrison, Matthew J.; Krasting, John P.; Malyshev, Sergey L.; Milly, P.C.D.; Phillipps, Peter J.; Sentman, Lori A.; Samuels, Bonita L.; Spelman, Michael J.; Winton, Michael; Wittenberg, Andrew T.; Zadeh, Niki

    2012-01-01

    We describe the physical climate formulation and simulation characteristics of two new global coupled carbon-climate Earth System Models, ESM2M and ESM2G. These models demonstrate similar climate fidelity as the Geophysical Fluid Dynamics Laboratory's previous CM2.1 climate model while incorporating explicit and consistent carbon dynamics. The two models differ exclusively in the physical ocean component; ESM2M uses Modular Ocean Model version 4.1 with vertical pressure layers while ESM2G uses Generalized Ocean Layer Dynamics with a bulk mixed layer and interior isopycnal layers. Differences in the ocean mean state include the thermocline depth being relatively deep in ESM2M and relatively shallow in ESM2G compared to observations. The crucial role of ocean dynamics on climate variability is highlighted in the El Niño-Southern Oscillation being overly strong in ESM2M and overly weak ESM2G relative to observations. Thus, while ESM2G might better represent climate changes relating to: total heat content variability given its lack of long term drift, gyre circulation and ventilation in the North Pacific, tropical Atlantic and Indian Oceans, and depth structure in the overturning and abyssal flows, ESM2M might better represent climate changes relating to: surface circulation given its superior surface temperature, salinity and height patterns, tropical Pacific circulation and variability, and Southern Ocean dynamics. Our overall assessment is that neither model is fundamentally superior to the other, and that both models achieve sufficient fidelity to allow meaningful climate and earth system modeling applications. This affords us the ability to assess the role of ocean configuration on earth system interactions in the context of two state-of-the-art coupled carbon-climate models.

  2. Baseline characteristics and statistical implications for the OECD 210 fish early-life stage chronic toxicity test.

    PubMed

    Oris, James T; Belanger, Scott E; Bailer, A John

    2012-02-01

    The fish toxicity assay most commonly used to establish chronic effects is the Organisation for Economic Co-operation and Development (OECD) 210, fish early-life stage test. However, the authors are not aware of any systematic analysis of the experimental design or statistical characteristics of the test since the test guideline was adopted nearly 20 years ago. Here, the authors report the results of an analysis of data compiled from OECD 210 tests conducted by industry labs. The distribution of responses observed in control treatments was analyzed, with the goal of understanding the implication of this variability on the sensitivity of the OECD 210 test guideline and providing recommendations on revised experimental design requirements of the test. Studies were confined to fathead minnows, rainbow trout, and zebrafish. Dichotomous endpoints (hatching success and posthatch survival) were examined for indications of overdispersion to evaluate whether significant chamber-to-chamber variability was present. Dichotomous and continuous (length, wet wt, dry wt) measurement endpoints were analyzed to determine minimum sample size requirements to detect differences from control responses with specified power. Results of the analysis indicated that sensitivity of the test could be improved by maximizing the number of replicate chambers per treatment concentration, increasing the acceptable level of control hatching success and larval survival compared to current levels, using wet weight measurements rather than dry weight, and focusing test efforts on species that demonstrate less variability in outcome measures. From these analyses, the authors provide evidence of the impact of expected levels of variability on the sensitivity of traditional OECD 210 studies and the implications for defining a target for future animal alternative methods for chronic toxicity testing in fish. Copyright © 2011 SETAC.

  3. Baseline characteristics and 1-year follow-up of Chinese atrial fibrillation patients according to age: a registry study.

    PubMed

    Chen, Tao; Yang, Yan-Min; Tan, Hui-Qiong; Liang, Yan; Zhu, Jun

    2014-10-01

    The prevalence of atrial fibrillation (AF) increases with age, and may lead to complications and reduced quality of life. The aim of this study was to determine the characteristics, management, and prognosis of Chinese AF patients and whether there were differences according to age. This registry-based study enrolled ambulatory, outpatient clinic, or hospitalized patients with AF in four sites in China. Based on the Birmingham 2009 schema, patients without and with valve lesion were stratified into three groups according to age. Between September 2008 and April 2011, 2,016 patients were enrolled, including 1,606 patients without valve lesion and 410 patients with valve lesion. Compared with the other two groups, patients >74 years of age were more likely to have morbidity and a CHADS2 score >1, and less likely to receive oral anticoagulants and rhythm-control drugs. At the 1-year follow-up, patients >74 years of age were more likely to have died or suffered a cerebrovascular event or systemic embolism. Age as a continuous variable (subdivided hazard ratio [SHR] 0.98, 95% confidence interval [CI] 0.96-1.01, P = 0.29) was not associated with risk of a cerebrovascular event or systemic embolism at 1-year but age ≥75 years (SHR 1.73, 95% CI 1.05-2.87, P = 0.03) was an independent risk factor for the outcome at 1-year when all AF patients were included. Elderly AF patients are inadequately studied and treated compared with younger patients. Education on evidence-based management and the design of randomized controlled trials, specifically targeting the elderly, especially the Chinese elderly, should improve the management and prognosis of this frail segment of the AF population. ©2014 Wiley Periodicals, Inc.

  4. Baseline program

    NASA Technical Reports Server (NTRS)

    Roberts, Barney B.; Vonputtkamer, Jesco

    1992-01-01

    This assumed program was developed from several sources of information and is extrapolated over future decades using a set of reasonable assumptions based on incremental growth. The assumptions for the NASA baseline program are as follows: balanced emphasis in four domains; a constant level of activity; low to moderate real budget growth; maximum use of commonality; and realistic and practical technology development. The first domain is low Earth Orbit (LEO). Activities there are concentrated on the space station but extend on one side to Earth-pointing sensors for unmanned platforms and on the other to the launch and staging of unmanned solar system exploration missions. The second domain is geosynchronous Earth orbit (GEO) and cislunar space. Activities here include all GEO missions and operations, both unmanned and manned, and all transport of materials and crews between LEO and the vicinity of the Moon. The third domain is the Moon itself. Lunar activities are to include both orbiting and landing missions; the landings may be either unmanned or manned. The last domain is Mars. Missions to Mars will initially be unmanned but they will eventually be manned. Program elements and descriptions are discussed as are critiques of the NASA baseline.

  5. An initial loading-dose vitamin D versus placebo after hip fracture surgery: baseline characteristics of a randomized controlled trial (REVITAHIP)

    PubMed Central

    2014-01-01

    Background Hypovitaminosis D is particularly common among older people with a proximal femoral (hip) fracture. There are currently no agreed strategies for vitamin D replenishment after hip fracture surgery. The REVITAHIP Study is a multisite, double-blinded randomized-controlled trial investigating the effects of an oral vitamin D loading dose on gait velocity after hip fracture surgery. We describe the baseline characteristics of participants, aiming to document hypovitaminosis D and its associations after hip fracture. Methods Participants, over 65, recruited within 7 days following hip fracture surgery from 3 Australia hospitals, were randomly allocated to receive a loading dose of vitamin D3 (250,000IU) or placebo, followed by oral maintenance vitamin D3/calcium (800 IU/500 mg) and the usual hip fracture rehabilitation pathway. Demographic and clinical data were collected, including surgical procedure, pre-fracture functional status, Mini Mental State Examination (MMSE) score, serum 25-hydroxyvitamin D (25-OHD), Verbal Rating Scale (VRS) for pain, grip strength and gait velocity. The associations of baseline 25-OHD levels with demographic and clinical data were assessed using Pearson’s correlation, ANOVA and regression analyses. Results Two-hundred-and-eighteen people with hip fracture participated in the study. Mean age was 83.9+/-7.2 years, 77% were women and 82% lived in private homes. Fifty-six percent had a subcapital fracture. Mean comorbidity count was 3.13+/-2.0. Mean MMSE was 26.1+/-3.9. Forty-seven percent of participants had hypovitaminosis D (<50 nmol/L). Multivariate regression models demonstrated higher baseline vitamin D levels were significantly associated with higher premorbid Barthel index scores, lower post-operative VRS pain levels and use of vitamin D. Conclusion This study cohort shared similar demographic characteristics and comorbidities with other cohorts of people with hip fracture, with the probable exception of less cognitive

  6. Understanding multifactorial influences on the continuum of maternal weight trajectories in pregnancy and early postpartum: study protocol, and participant baseline characteristics.

    PubMed

    Moore Simas, Tiffany A; Corvera, Silvia; Lee, Mary M; Zhang, NingNing; Leung, Katherine; Olendzki, Barbara; Barton, Bruce; Rosal, Milagros C

    2015-03-28

    Maternal and offspring immediate and long-term health are affected by pregnancy weight gain and maternal weight. This study was designed to determine feasibility of: 1) recruiting a socio-economically and racially/ethnically diverse sample of pregnant women into a longitudinal observational study, including consenting the women for serial biologic specimen evaluations; 2) implementing comprehensive assessments (including biologic, anthropometric, behavioral, cognitive/psychosocial and socio-demographic, and cultural measures) at multiple time points over the study period, including collecting biologic specimens at planned and unplanned pregnancy delivery times; and 3) retaining the sample for one year into the postpartum period. Additionally, the study will provide preliminary data of associations among hypothesized predictors, mediators and moderators of pregnancy and post-partum maternal and infant weight trajectories. The study was conceptualized under a Biopsychosocial Model using a lifespan approach. Study protocol and baseline characteristics are described. We sought to recruit a sample of 100 healthy women age 18-45 years, between 28-34 weeks gestation, with singleton pregnancies, enrolled in care prior to 17 weeks gestation. Women provide written consent for face-to-face (medical history, anthropometrics, biologic specimens), and paper-and-pencil assessments, at five time points: baseline (third trimester), delivery-associated, and 6-weeks, 3-months and 6-months postpartum. Additional telephone-based assessments (diet, physical activity and breastfeeding) administered baseline and three-months postpartum. Infant weights are collected until 1-year of life. We seek to retain 80% of participants at six-months postpartum and 80% of offspring at 12-months. 110 women were recruited. Sample characteristics include: mean age 28.3 years, BMI 25.7 kg/m(2), and gestational age at baseline visit of 32.5 weeks. One-third of cohort was non-white, over a quarter were

  7. Low dose of insulin detemir controls glycaemia, insulinemia and prevents diabetes mellitus progression in the dog with pituitary-dependent hyperadrenocorticism.

    PubMed

    Miceli, D D; Gallelli, M F; Cabrera Blatter, M F; Martiarena, B; Brañas, M M; Ortemberg, L R; Gómez, N V; Castillo, V A

    2012-08-01

    Diabetes is often associated with pituitary-dependent hyperadrenocorticism (PDH). Hypercortisolism causes insulin resistance and affects β-cell function. The purpose of this study was to test if daily administration of a long-acting insulin analogue during the first month of anti-PDH treatment can prevent progress to diabetes in these animals. Twenty-six PDH dogs were divided into three groups: one group with glycaemia <5.83 mmol/L and two groups with glycaemia >5.83 mmol/L and <9.35 mmol/L, one of which received insulin detemir during 4 months. Dogs with glycaemia <5.83 mmol/L and those with glycaemia >5.83 mmol/L which received insulin did not develop diabetes. In the non-insulin group, 6/7 dogs developed diabetes after the third month. There is a 13-fold higher risk of diabetes in dogs with glycaemia >5.83 mmol/L and no insulin treatment. Administering insulin detemir to dogs with PDH and glycaemia >5.83 mmol/L could prevent progression to diabetes.

  8. Most Trial Eligibility Criteria and Patient Baseline Characteristics Do Not Modify Treatment Effect in Trials Using Targeted Therapies for Rheumatoid Arthritis: A Meta-Epidemiological Study

    PubMed Central

    Christensen, Anton Wulf; Tarp, Simon; Furst, Daniel E.; Døssing, Anna; Amris, Kirstine; Bliddal, Henning; Taylor, Peter C.; Christensen, Robin

    2015-01-01

    Objective To determine if variations in trial eligibility criteria and patient baseline characteristics could be considered effect modifiers of the treatment response when testing targeted therapies (biological agents and targeted synthetic disease modifying antirheumatic drugs (DMARDs)) for rheumatoid arthritis (RA). Methods We conducted a meta-epidemiological study of all trials evaluating a targeted therapy approved by regulatory authorities for treating RA. The database search was completed on December 11th 2013. Eligible trials reported ACR20 data at months 3–6 and used an add-on design. Odds ratios (ORs) were calculated from the response rates and compared among the trial eligibility criteria/patient baseline characteristics of interest. Comparisons are presented as the Ratio of Odds Ratios (ROR). Results Sixty-two trials (19,923 RA patients) were included in the primary analyses using ACR20 response. Overall, targeted therapies constituted an effective treatment (OR 3.96 95% confidence interval (CI) 3.41 to 4.60). The majority of the trial eligibility criteria and patient baseline characteristics did not modify treatment effect. The added benefit of targeted therapies was lower in trials including "DMARD-naïve" patients compared with trials including "DMARD inadequate responders" (ROR = 0.45, 95%CI 0.31 to 0.66) and trials including "targeted therapy inadequate responders" (0.50, 95%CI 0.29 to 0.87), test for interaction: p = 0.0002. Longer mean disease duration was associated with a higher likelihood of responding to treatment (β = 1.05, 95%CI 1.00 to 1.11 OR’s per year; p = 0.03). Analyses conducted using DAS28-remission as the outcome supported the above-mentioned findings. Conclusion Our results suggest that a highly selective inclusion is not associated with greater treatment effect, as might otherwise be expected. The added benefit of a targeted therapy was lower in trials including patients who were DMARD-naïve and trials including patients

  9. In patients with minimally symptomatic OSA can baseline characteristics and early patterns of CPAP usage predict those who are likely to be longer-term users of CPAP

    PubMed Central

    Bratton, Daniel J.; Craig, Sonya E.; Kohler, Malcolm; Stradling, John R.

    2016-01-01

    Background Long-term continuous positive airway pressure (CPAP) usage varies between individuals. It would be of value to be able to identify those who are likely to benefit from CPAP (and use it long term), versus those who would not, and might therefore benefit from additional help early on. First, we explored whether baseline characteristics predicted CPAP usage in minimally symptomatic obstructive sleep apnoea (OSA) patients, a group who would be expected to have low usage. Second, we explored if early CPAP usage was predictive of longer-term usage, as has been shown in more symptomatic OSA patients. Methods The MOSAIC trial was a multi-centre randomised controlled trial where minimally symptomatic OSA patients were randomised to CPAP, or standard care, for 6 months. Here we have studied only those patients randomised to CPAP treatment. Baseline characteristics including symptoms, questionnaires [including the Epworth sleepiness score (ESS)] and sleep study parameters were recorded. CPAP usage was recorded at 2–4 weeks after initiation and after 6 months. The correlation and association between baseline characteristics and 6 months CPAP usage was assessed, as was the correlation between 2 and 4 weeks CPAP usage and 6 months CPAP usage. Results One hundred and ninety-five patients randomised to CPAP therapy had median [interquartile range (IQR)] CPAP usage of 2:49 (0:44, 5:13) h:min/night (h/n) at the 2–4 weeks visit, and 2:17 (0:08, 4:54) h/n at the 6 months follow-up visit. Only male gender was associated with increased long-term CPAP use (male usage 2:56 h/n, female 1:57 h/n; P=0.02). There was a moderate correlation between the usage of CPAP at 2–4 weeks and 6 months, with about 50% of the variability in long-term use being predicted by the short-term use. Conclusions In patients with minimally symptomatic OSA, our study has shown that male gender (and not OSA severity or symptom burden) is associated with increased long-term use of CPAP at 6 months

  10. Investigation into the Value of Trained Glycaemia Alert Dogs to Clients with Type I Diabetes

    PubMed Central

    Rooney, Nicola J.; Morant, Steve; Guest, Claire

    2013-01-01

    Previous studies have suggested that some pet dogs respond to their owners’ hypoglycaemic state. Here, we show that trained glycaemia alert dogs placed with clients living with diabetes afford significant improvements to owner well-being. We investigated whether trained dogs reliably respond to their owners’ hypoglycaemic state, and whether owners experience facilitated tightened glycaemic control, and wider psychosocial benefits. Since obtaining their dog, all seventeen clients studied reported positive effects including reduced paramedic call outs, decreased unconscious episodes and improved independence. Owner-recorded data showed that dogs alerted their owners, with significant, though variable, accuracy at times of low and high blood sugar. Eight out of the ten dogs (for which owners provided adequate records) responded consistently more often when their owner’s blood sugars were reported to be outside, than within, target range. Comparison of nine clients’ routine records showed significant overall change after obtaining their dogs, with seven clients recording a significantly higher proportion of routine tests within target range after obtaining a dog. HbA1C showed a small, non significant reduction after dog allocation. Based on owner-reported data we have shown, for the first time, that trained detection dogs perform above chance level. This study points to the potential value of alert dogs, for increasing glycaemic control, client independence and consequent quality of life and even reducing the costs of long-term health care. PMID:23950905

  11. Impact of polyphenol-rich sources on acute postprandial glycaemia: a systematic review.

    PubMed

    Coe, S; Ryan, L

    2016-01-01

    Increasingly, evidence suggests a role for polyphenols in blood glucose control. The objective of this systematic review was to evaluate the effect of polyphenol-rich sources in combination with carbohydrate sources on resulting postprandial glycaemic and insulin responses. A literature search was conducted using Medline, CINHAL and Web of Science databases. Selected studies included randomised controlled trials in which the association of polyphenol-containing food or beverage consumption with a carbohydrate source and effect on acute postprandial glycaemia and/or insulin was reported. A total of thirteen full articles were included in the review. Polyphenol sources included coffee, black tea, fruit juice, plant extracts, berries and different rye breads, and carbohydrate sources included bread, pancakes and simple sugars such as sucrose, glucose and fructose. Although glycaemic and insulin responses differed depending on the polyphenol-carbohydrate combination, overall, polyphenol sources were shown to reduce the peak and early-phase glycaemic response and maintain the glycaemic response in the later stages of digestion. To a lesser extent, polyphenol sources were also shown to reduce peak insulin response and sustain the insulin response, especially when consumed with bread. This review supports epidemiological data suggesting that polyphenols in foods and beverages may have a beneficial effect on reducing the risk of type 2 diabetes. However, the extent of this effect is variable depending on the polyphenol and carbohydrate source.

  12. Recruitment and baseline characteristics of participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)-a randomized controlled lifestyle trial.

    PubMed

    Ngandu, Tiia; Lehtisalo, Jenni; Levälahti, Esko; Laatikainen, Tiina; Lindström, Jaana; Peltonen, Markku; Solomon, Alina; Ahtiluoto, Satu; Antikainen, Riitta; Hänninen, Tuomo; Jula, Antti; Mangialasche, Francesca; Paajanen, Teemu; Pajala, Satu; Rauramaa, Rainer; Strandberg, Timo; Tuomilehto, Jaakko; Soininen, Hilkka; Kivipelto, Miia

    2014-09-10

    Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study population. Potential study participants (age 60-77 years, the dementia risk score ≥ 6) were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496), 48% (n = 2654) attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1). The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD) age of the randomized participants was 69.4 (4.7) years, Mini-Mental State Examination 26.7 (2.0) points, systolic blood pressure 140.1 (16.2) mmHg, total serum cholesterol 5.2 (1.0) mmol/L for, and fasting glucose 6.1 (0.9) mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons.

  13. Baseline Socio-demographic characteristics and self-reported diet and physical activity shifts among recent immigrants participating in the randomized controlled lifestyle intervention: "Live Well".

    PubMed

    Tovar, Alison; Boulos, Rebecca; Sliwa, Sarah; Must, Aviva; Gute, David M; Metayer, Nesly; Hyatt, Raymond R; Chui, Kenneth; Pirie, Alex; Luongo, Christina Kamis; Economos, Christina

    2014-06-01

    The goal of this paper is to describe the baseline characteristics of Live Well (intervention to prevent weight gain in recent immigrant mother-child dyads from Brazil, Haiti, and Latin America) participants, and to explore self-reported changes in diet and physical activity post-immigration. Baseline data from 383 mothers were used for this study. Dyads attended a measurement day where they completed self-administered surveys collecting information about socio-demographics, diet, physical activity, other psychosocial variables, and height and weight. Haitian mothers' socio-demographic profile differed significantly from that of Brazilians' and Latinas': they have been in the US for a shorter period of time, have higher rates of unemployment, are less likely to be married, more likely to have ≥3 children, more likely to be obese, and have immigrated for family or other reasons. In multivariate models, self-reported changes in diet and physical activity since migrating to the US were significantly associated with BMI with non-linear relationships identified. Future research is needed to understand how diet and physical activity change while acculturating to the US and explore the adoption of both healthy and unhealthy dietary changes.

  14. An adaptive, dose-finding, seamless phase 2/3 study of a long-acting glucagon-like peptide-1 analog (dulaglutide): trial design and baseline characteristics.

    PubMed

    Geiger, Mary Jane; Skrivanek, Zachary; Gaydos, Brenda; Chien, Jenny; Berry, Scott; Berry, Donald

    2012-11-01

    Dulaglutide (dula, LY2189265) is a once-weekly glucagon-like peptide-1 analog in development for the treatment of type 2 diabetes mellitus. An adaptive, dose-finding, inferentially seamless phase 2/3 study was designed to support the development of this novel diabetes therapeutic. The study is divided into two stages based on two randomization schemes: a Bayesian adaptive scheme (stage 1) and a fixed scheme (stage 2). Stage 1 of the trial employs an adaptive, dose-finding design to lead to a dula dose-selection decision or early study termination due to futility. If dose selection occurs, the study proceeds to stage 2 to allow continued evaluation of the selected dula doses. At completion, the entire study will serve as a confirmatory phase 3 trial. The final study design is discussed, along with specifics pertaining to the actual execution of this study and selected baseline characteristics of the participants. © 2012 Diabetes Technology Society.

  15. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation in patients with systolic heart failure: rationale, design, and baseline patient characteristics.

    PubMed

    Abraham, William T; Burkhoff, Daniel; Nademanee, Koonlawee; Carson, Peter; Bourge, Robert; Ellenbogen, Kenneth A; Parides, Michael; Kadish, Alan

    2008-10-01

    Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the cardiac absolute refractory period that enhance the strength of cardiac muscular contraction. Prior research in experimental and human heart failure has shown that CCM signals normalize phosphorylation of key proteins and expression of genes coding for proteins involved in regulation of calcium cycling and contraction. The results of prior clinical studies of CCM have supported its safety and efficacy. A large-scale clinical study, the FIX-HF-5 study, is currently underway to test the safety and efficacy of this treatment. In this article, we provide an overview of the system used to deliver CCM signals, the implant procedure, and the details and rationale of the FIX-HF-5 study design. Baseline characteristics for patients randomized in this trial are also presented.

  16. Back pain-related disability and quality of life in patients affected by vertebral fractures: data from baseline characteristics of population enrolled in Denosumab In Real Practice (DIRP).

    PubMed

    Moretti, Antimo; Gimigliano, Francesca; Di Pietro, Gioconda; Gimigliano, Raffaele; Iolascon, Giovanni

    2015-10-01

    Spine fragility fractures lead to a significant acute and/or chronic pain and worsening of quality of life. Denosumab is effective in reducing the risk of new vertebral fractures, but its effectiveness on pain relief and improvement of the quality of life in patients with spine fractures are not well known. The aim of this paper is to describe the baseline demographic and clinical characteristics, back pain-related disability and quality of life of the Denosumab In Real Practice (DIRP) study population. DIRP is a multicenter prospective observational study evaluating the effectiveness of denosumab in reducing back pain-related disability and Health-Related Quality of Life (HRQoL) of women with postmenopausal osteoporosis who had already experienced at least one vertebral fragility fracture. Our evaluation protocol includes history of fractures, Spine Pain Index (SPI), HRQoL, bone mineral density (BMD) and radiological assessment of vertebral fragility fractures. Two hundred and twenty-three post-menopausal women, who received a prescription for denosumab, were enrolled. The mean SPI score was 58.6 ± 21.4 SD, and 187 (83.86%) women experienced a moderate-severe pain. The mean HRQoL health state value was 0.54 ± 0.27 SD using EQ-5D index, whereas the mean Physical and Mental Health Composite Scale scores derived from the SF-12 were 31.06 ± 7.77 SD and 39.20 ± 11.03 SD. Baseline characteristics of DIRP study cohort indicate that patients who received a prescription of denosumab in Campania region are affected by severe osteoporosis with highly prevalent vertebral fractures, disabling back pain and poor health-related quality of life. This is in contradiction with what it is expected by a front-line drug for osteoporosis.

  17. Design and baseline characteristics of a population-based study of eye disease in southern Chinese people: the Dongguan Eye Study.

    PubMed

    Meng, Qianli; Cui, Ying; Zhang, Min; Zhang, Lixin; Zhang, Liang; Zhang, Jinxin; Kuang, Jian; Liu, Qingyang; Zheng, Yang; Luo, Zhongling; Liu, Huikun; Zhu, Guoping; Cai, Jingjing; Zhang, Guanrong; Wen, Xingxuan; Guo, Haike

    2016-04-01

    To describe the study design, methodology and baseline characteristics of the Dongguan Eye Study. Population-based, cross-sectional study A total of 8952 rural-dwelling residents aged 40 years or older in Hengli, Dongguan. The Dongguan Eye Study was conducted from September 2011 to February 2012. The interview covered demographic data, socio-economic status and health- and vision-related quality of life. Physical measurements included height, weight, waist and hip circumference, heart rate and blood pressure. Laboratory tests included fasting blood glucose, haemoglobin A1c, oral glucose tolerance, serum total cholesterol, triglycerides, high-density lipoprotein-cholesterol, low-density lipoprotein-cholesterol, serum creatinine, blood urea nitrogen and uric acid. Ophthalmic examinations included visual acuity and autorefraction testing, intraocular pressure measurement, slit-lamp examination, ocular biometry, gonioscopy, fundus photography, retinal nerve fibre layer imaging and visual field testing. Prevalence and risk factors for visual impairment, blindness, eye diseases and their associations with systemic medical indicators or health-related lifestyles, as well as epidemiological data on diabetic subjects. Methodology, response rates and baseline characteristics are presented. Of the 11 357 individuals eligible for the Dongguan Eye Study, 8952 (78.82%) subjects participated. All participants were self-identified Han Chinese. The average age was 54.0 years, 59.9% were female, 48.4% were farmers and 77.2% had elementary or junior middle school educational levels. The average body mass index and waist-hip ratio were 24.6 ± 3.9 kg/m(2) and 0.9 ± 0.2. Data from the Dongguan Eye Study provide information concerning the prevalence, risk factors and impacts of eye diseases in rural residents undergoing urbanization in southern China. © 2015 Royal Australian and New Zealand College of Ophthalmologists.

  18. Trial baseline characteristics of a cluster randomised controlled trial of a school-located obesity prevention programme; the Healthy Lifestyles Programme (HeLP) trial.

    PubMed

    Lloyd, Jenny; Creanor, Siobhan; Price, Lisa; Abraham, Charles; Dean, Sarah; Green, Colin; Hillsdon, Melvyn; Pearson, Virginia; Taylor, Rod S; Tomlinson, Richard; Logan, Stuart; Hurst, Alison; Ryan, Emma; Daurge, Wendy; Wyatt, Katrina

    2017-04-04

    We have developed a healthy lifestyles programme (HeLP) for primary school aged children (9-10 years), currently being evaluated in a definitive cluster randomised controlled trial. This paper descriptively presents the baseline characteristics of trial children (BMI, waist circumference, % body fat, diet and physical activity) by gender, cluster level socio-economic status, school size and time of recruitment into the trial. Schools were recruited from across the South West of England and allocated 1:1 to either intervention (HeLP) or control (usual practice) stratified by the proportion of children eligible for free school meals (FSM, <19%, ≥19%) and school size (one Year 5 class, >1 Year 5 class). The primary outcome is change in body mass index standard deviation score (BMI sds) at 24 months post-randomisation. Secondary outcomes are BMI sds at 18 months, waist circumference and percentage body fat sds at 18 and 24 months, proportion of children classified as underweight, overweight and obese at 18 and 24 months, physical activity (for a sub-sample) and food intake at 18 months. At baseline 11.4% and 13.6% of children were categorised as overweight or obese respectively. A higher percentage of girls than boys (25.3% vs 24.8%) and children from schools in FSM category 2 (28.2% vs 23.2%) were overweight or obese. Children were consuming a mean (range) of 4.15 (0-13) energy dense snacks (EDS) and 3.23 (0-9) healthy snacks (HS) per day with children from schools in FSM category 2 consuming more EDS and negative food markers and less HS and positive food markers. Children spent an average 53.6 min per day (11.9 to 124.8) in MVPA and thirteen hours (779.3 min) per day (11 h to 15 h) doing less than 'light' intensity activity. Less than 5% of children achieved the Departments of Health's recommendation of 60 min of MVPA every day. We have excellent completeness of baseline data for all measures and have achieved compliance to accelerometry not seen

  19. Mechanism of action study to evaluate the effect of rosiglitazone on bone in postmenopausal women with type 2 diabetes mellitus: rationale, study design and baseline characteristics

    PubMed Central

    Fitzpatrick, Lorraine A.; Bilezikian, John P.; Wooddell, Margaret; Paul, Gitanjali; Kolatkar, Nikheel S.; Nino, Antonio J.; Miller, Colin G.; Bogado, Cesar E.; Arnaud, Claude D.; Cobitz, Alexander R.

    2012-01-01

    Objectives Post-hoc analyses have shown an increase incidence of fractures among type 2 diabetes (T2DM) patients treated with thiazolidinediones (TZDs). The mechanisms by which TZDs may be associated with increased fracture risk is not well understood. This article describes the study design and baseline characteristics for a prospective, randomized, double-blind, active-controlled trial to evaluate the effects of rosiglitazone on changes in measures of skeletal structure, surrogates of bone strength and metabolism. Methods Postmenopausal women without osteoporosis and diagnosed with T2DM were randomized in a double-blind design to either rosiglitazone or metformin for 52 weeks, then all subjects received open-label metformin for 24 weeks. Study endpoints included changes in bone mineral density (BMD), quantitative computed tomography (QCT), digitized hip radiography (HXR) and high resolution magnetic resonance imaging (hrMRI). Serum markers of bone metabolism and indices of glycemic control were assessed within and between treatment groups. Results A total of 226 subjects were randomized. Baseline characteristics included: age 63.8 ± 6.5 years; years postmenopausal 16.9 ± 8.4; duration of diabetes 3.5 (1.8–7.8) years; body mass index (BMI) 31.4 ± 5.9 kg/m2; and glycated hemoglobin (HbA1c) 6.4 ± 0.65%. At baseline, mean T-scores were −0.95 ± 0.91 at the femoral neck, −0.02 ± 0.97 at the total hip and −0.55 ± 1.25 at the total spine. Since there are no well recognized techniques to determine bone mass and structure at the distal limbs (cortical bone sites where fractures were reported in RSG subjects), using the femoral neck as a surrogate for these areas may be a potential limitation of the study. Conclusion This is the first randomized trial utilizing multiple techniques to evaluate bone mass, structure, serum markers of bone remodeling, and potential reversibility of changes after discontinuation of rosiglitazone. This

  20. Baseline characteristics of the Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial population: comparison with other diabetes prevention trials.

    PubMed

    Krum, Henry; McMurray, John J V; Horton, Edward; Gerlock, Teresa; Holzhauer, Bjoern; Zuurman, Lineke; Haffner, Steven M; Bethel, M Angelyn; Holman, Rury R; Califf, Robert M

    2010-04-01

    The Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial is exploring two pharmacological strategies (nateglinide and valsartan, both alone and in combination) in the prevention of overt diabetes mellitus (DM) and the reduction of cardiovascular disease (CVD) in subjects at high risk for these events. In this analysis, we provide baseline characteristics of the randomized NAVIGATOR study population and contrast them with those from other trials of DM prevention. Key eligibility criteria include impaired glucose tolerance (IGT) and impaired fasting glucose (IFG), a history of CVD (in patients aged > or =50 years), and > or =1 cardiovascular risk factor (in patients aged > or =55 years). Baseline demographic characteristics, laboratory findings, cardiovascular risk factors, CVD history, and medication use are described and compared with other trials of DM prevention. The full analysis set of subjects (N = 9306) showed a clustering of risk factors consistent with the metabolic syndrome: high rates of hypertension (77.5%), dyslipidemia (44.7%), increased waist circumference (101.0 cm), and high body mass index (BMI) (47.5% with BMI > or =30 kg/m(2)). A minority of patients had a history of CVD (24.3%); of these, 11.7% had a history of myocardial infarction and most of the remainder had evidence of coronary artery disease. Subjects also had elevated blood pressure (BP) (predominantly systolic) (139.7/82.6 mm Hg), increased serum low-density lipoproteins cholesterol levels (3.27 mmol/L), and borderline elevation of triglyceride levels (1.97 mmol/L). Demographic data, BP, and lipid profiles in NAVIGATOR were similar to those of previous DM prevention trials, which were also based largely on meeting criteria for IGT. Medication use at baseline among NAVIGATOR subjects, which frequently included aspirin, beta-blockers, calcium channel blockers, diuretics, and lipid-lowering agents, reflects enhanced CVD risk. However, little prescribing

  1. Characteristics of patients with low back and leg pain seeking treatment in primary care: baseline results from the ATLAS cohort study.

    PubMed

    Konstantinou, Kika; Dunn, Kate M; Ogollah, Reuben; Vogel, Steven; Hay, Elaine M

    2015-11-04

    Patients with back pain radiating to the leg(s) report worse symptoms and poorer recovery than those with back pain alone. Robust evidence regarding their epidemiological profile is lacking from primary care, the setting where most of these patients will present and be managed. Our objective was to describe the characteristics of patients with back and leg pain, including sciatica, seeking treatment in primary care. Adults visiting their general practitioner with back and leg pain, of any duration and severity, were invited to participate. Participants completed questionnaires, underwent clinical assessments and received MRI scans. Characteristics of the sample are described, and differences between patients diagnosed with referred leg pain and those with sciatica are analysed. Six hundred nine patients participated; 62.6 % were female, mean (SD) age 50.2 (13.9). 67.5 % reported pain below the knee, 60.7 % were in paid employment with 39.7 % reporting time off work. Mean disability (RMDQ) was 12.7 (5.7) and mean pain intensity was 5.6 (2.2) and 5.2 (2.4) for back and leg respectively. Mean sciatica bothersomeness index (SBI) was 14.9 (5.1). Three quarters (74.2 %) were clinically diagnosed as having sciatica. In the sciatica group, leg pain intensity, neuropathic pain, pain below the knee, leg pain worse than back pain, SBI and positive MRI findings were significantly higher as compared to patients with referred leg pain. This primary care cohort reported high levels of disability and pain. This is the first epidemiological study of unselected primary care patients seeking healthcare for back and leg pain. Follow-up of this cohort will investigate the prognostic value of their baseline characteristics. This new information will contribute to our understanding of the characteristics and clinical features of this population, and will underpin future research aimed at defining prognostic subgroups to enable better targeting of health care provision.

  2. SKIN WRINKLES AND RIGIDITY IN EARLY POSTMENOPAUSAL WOMEN VARY BY RACE/ETHNICITY: BASELINE CHARACTERISTICS OF THE SKIN ANCILLARY STUDY OF THE KEEPS TRIAL

    PubMed Central

    Wolff, Erin; Pal, Lubna; Altun, Tugba; Madankumar, Rajeevi; Freeman, Ruth; Amin, Hussein; Harman, Mitch; Santoro, Nanette; Taylor, Hugh S.

    2010-01-01

    Objective To characterize skin wrinkles and rigidity in recently menopausal women. Design Baseline assessment of participants prior to randomization to study drug. Setting Multicenter trial, university medical centers. Patients Recently menopausal participants enrolled in the Kronos Early Estrogen Prevention Study (KEEPS). Interventions Skin wrinkles were assessed at 11 locations on the face and neck using the Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Outcome Skin wrinkles and rigidity were compared among race/ethnic groups. Skin wrinkles and rigidity were correlated with age, time since menopause, weight, and BMI. Results In early menopausal women, wrinkles, but not skin rigidity, vary significantly among races (p=0.0003), where Black women have the lowest wrinkle scores. In White women, chronological age was significantly correlated with worsening skin wrinkles, but not with rigidity(p<0.001). Skin rigidity correlated with increasing length of time since menopause, however only in the White subgroup (p<0.01). In the combined study group, increasing weight was associated with less skin wrinkling (p<0.05). Conclusions Skin characteristics of recently menopausal women are not well studied. Ethnic differences in skin characteristics are widely accepted, but poorly described. In recently menopausal women not using hormone therapy (HT), significant racial differences in skin wrinkling and rigidity exist. Continued study of the KEEPS population will provide evidence of the effects of HT on the skin aging process in early menopausal women. PMID:20971461

  3. Skin wrinkles and rigidity in early postmenopausal women vary by race/ethnicity: baseline characteristics of the skin ancillary study of the KEEPS trial.

    PubMed

    Wolff, Erin; Pal, Lubna; Altun, Tugba; Madankumar, Rajeevi; Freeman, Ruth; Amin, Hussein; Harman, Mitch; Santoro, Nanette; Taylor, Hugh S

    2011-02-01

    To characterize skin wrinkles and rigidity in recently menopausal women. Baseline assessment of participants before randomization to study drug. Multicenter trial, university medical centers. Recently menopausal participants enrolled in the Kronos Early Estrogen Prevention Study (KEEPS). Skin wrinkles were assessed at 11 locations on the face and neck using the Lemperle wrinkle scale. Skin rigidity was assessed at the forehead and cheek using a durometer. Skin wrinkles and rigidity were compared among race/ethnic groups. Skin wrinkles and rigidity were correlated with age, time since menopause, weight, and body mass index (BMI). In early menopausal women, wrinkles, but not skin rigidity, vary significantly among races, where black women have the lowest wrinkle scores. In white women, chronological age was significantly correlated with worsening skin wrinkles, but not with rigidity. Skin rigidity correlated with increasing length of time since menopause, however, only in the white subgroup. In the combined study group, increasing weight was associated with less skin wrinkling. Skin characteristics of recently menopausal women are not well studied. Ethnic differences in skin characteristics are widely accepted, but poorly described. In recently menopausal women not using hormone therapy (HT), significant racial differences in skin wrinkling and rigidity exist. Continued study of the KEEPS population will provide evidence of the effects of HT on the skin aging process in early menopausal women. Copyright © 2011 American Society for Reproductive Medicine. All rights reserved.

  4. The Hispanic Americans Baseline Alcohol Survey (HABLAS):Predictive invariance of Demographic Characteristics on Attitudes towards Alcohol across Hispanic National Groups.

    PubMed

    Mills, Britain A; Caetano, Raul; Bernstein, Ira H

    2010-01-01

    This study compares the demographic predictors of items assessing attitudes towards drinking across Hispanic national groups. Data were from the 2006 Hispanic Americans Baseline Alcohol Survey (HABLAS), which used a multistage cluster sample design to interview 5,224 individuals randomly selected from the household population in Miami, New York, Philadelphia, Houston, and Los Angeles. Predictive invariance of demographic predictors of alcohol attitudes over four Hispanic national groups (Puerto Rican, Cuban, Mexican, and South/Central Americans) was examined using multiple-group seemingly unrelated probit regression. The analyses examined whether the influence of various demographic predictors varied across the Hispanic national groups in their regression coefficients, item intercepts, and error correlations. The hypothesis of predictive invariance was supported. Hispanic groups did not differ in how demographic predictors related to individual attitudinal items (regression slopes were invariant). In addition, the groups did not differ in attitudinal endorsement rates once demographic covariates were taken into account (item intercepts were invariant). Although Hispanic groups have different attitudes about alcohol, the influence of multiple demographic characteristics on alcohol attitudes operates similarly across Hispanic groups. Future models of drinking behavior in adult Hispanics need not posit moderating effects of group on the relation between these background characteristics and attitudes.

  5. The Hispanic Americans Baseline Alcohol Survey (HABLAS):Predictive invariance of Demographic Characteristics on Attitudes towards Alcohol across Hispanic National Groups#

    PubMed Central

    Mills, Britain A.; Caetano, Raul; Bernstein, Ira H.

    2011-01-01

    This study compares the demographic predictors of items assessing attitudes towards drinking across Hispanic national groups. Data were from the 2006 Hispanic Americans Baseline Alcohol Survey (HABLAS), which used a multistage cluster sample design to interview 5,224 individuals randomly selected from the household population in Miami, New York, Philadelphia, Houston, and Los Angeles. Predictive invariance of demographic predictors of alcohol attitudes over four Hispanic national groups (Puerto Rican, Cuban, Mexican, and South/Central Americans) was examined using multiple-group seemingly unrelated probit regression. The analyses examined whether the influence of various demographic predictors varied across the Hispanic national groups in their regression coefficients, item intercepts, and error correlations. The hypothesis of predictive invariance was supported. Hispanic groups did not differ in how demographic predictors related to individual attitudinal items (regression slopes were invariant). In addition, the groups did not differ in attitudinal endorsement rates once demographic covariates were taken into account (item intercepts were invariant). Although Hispanic groups have different attitudes about alcohol, the influence of multiple demographic characteristics on alcohol attitudes operates similarly across Hispanic groups. Future models of drinking behavior in adult Hispanics need not posit moderating effects of group on the relation between these background characteristics and attitudes. PMID:25379120

  6. Effect of patient characteristics on the yield of prolonged baseline head-up tilt testing and the additional yield of drug provocation.

    PubMed Central

    Fitzpatrick, A. P.; Lee, R. J.; Epstein, L. M.; Lesh, M. D.; Eisenberg, S.; Sheinman, M. M.

    1996-01-01

    factors were combined, the yield ranged from 0% for 21 patients under 50 years with SHD or SDC and without recurrent syncope to 73% in 11 patients over 50 years with recurrent syncope and no SHD or SDC. The additional yield in subgroups over 45 minute baseline tilt (70 (11)%) of isoprenaline (13 (10)%) was similar to that of edrophonium (17 (8)%, P = NS), but six (50% of those who were drug positive) patients required a second drug to produce a positive result (two with isoprenaline second, four with edrophonium second). CONCLUSIONS: Head-up tilt testing in a heterogeneous population has a low yield. Simple clinical characteristics define the type of patient who is likely to have a positive tilt test and the patient who is not and in whom other investigations should receive priority. The great majority of positive tests will occur during prolonged baseline testing if this is used. Isoprenaline and edrophonium produced similar additional yields of positive tests. Images PMID:8963892

  7. Diet and glycaemia: the markers and their meaning. A report of the Unilever Nutrition Workshop.

    PubMed

    Alssema, Marjan; Boers, Hanny M; Ceriello, Antonio; Kilpatrick, Eric S; Mela, David J; Priebe, Marion G; Schrauwen, Patrick; Wolffenbuttel, Bruce H; Pfeiffer, Andreas F H

    2015-01-28

    Consumption of carbohydrate-containing foods leads to transient postprandial rises in blood glucose concentrations that vary between food types. Higher postprandial glycaemic exposures have particularly been implicated in the development of chronic cardiometabolic diseases. Reducing such diet-related exposures may be beneficial not only for diabetic patients but also for the general population. A variety of markers have been used to track different aspects of glycaemic exposures, with most of the relevant knowledge derived from diabetic patients. The assessment of glycaemic exposures among the non-diabetic population may require other, more sensitive markers. The present report summarises key messages of presentations and related discussions from a workshop organised by Unilever intended to consider currently applied markers of glycaemic exposure. The particular focus of the meeting was to identify the potential applicability of glycaemic exposure markers for studying dietary effects in the non-diabetic population. Workshop participants concluded that markers of glycaemic exposures are sparsely used in intervention studies among non-diabetic populations. Continuous glucose monitoring remains the optimal approach to directly assess glycaemic exposure. Markers of glycaemic exposure such as glycated Hb, fructosamine, glycated albumin, 1,5-anhydroglucitol and advanced glycation end products can be preferred dependent on the aspect of interest (period of exposure and glucose variability). For all the markers of glycaemia, the responsiveness to interventions will probably be smaller among the non-diabetic than among the diabetic population. Further validation and acceptance of existing glycaemic exposure markers applied among the non-diabetic population would aid food innovation and better design of dietary interventions targeting glycaemic exposure.

  8. The design, rationale, and baseline characteristics of a nationwide cohort registry in China: blood pressure and clinical outcome in TIA or ischemic stroke

    PubMed Central

    Xu, Jie; Liu, Yi; Tao, Yongli; Xie, Xuewei; Gu, Hongqiu; Pan, Yuesong; Zhao, Xingquan; Wang, Yongjun; Yan, Aoshuang; Wang, Yilong

    2016-01-01

    Background The relationship between poststroke blood pressure (BP) and clinical outcomes in ischemic stroke (IS) is still controversial. However, there is no large BP database for IS or transient ischemic attack (TIA) in China. This study aims to describe the rationale, study design, and baseline characteristics of a nationwide BP database in IS or TIA patients in China. Materials and methods The BOSS (blood pressure and clinical outcome in TIA or ischemic stroke) study was a hospital-based, prospective cohort study aiming to assess BP parameters and clinical outcome in IS/TIA patients. BP parameters were based on office BP, ambulatory BP, and home BP. Clinical outcomes included stroke recurrence, combined vascular events, and disability. Electronic case-report forms were used to record baseline and follow-up data. The patients were followed up for clinical outcomes at 3 months through face-to-face interview and at 12 months by telephone. Results Between October 2012 and February 2014, the BOSS registry recruited 2,608 patients from 61 hospitals, with a mean age of 62.5 years, 32.4% of whom were female, 88.9% with an entry diagnosis of IS, and 86% diagnosed with hypertension. The rates of patients lost-to-follow-up were 3.1% at 3 months and 5.1% at 1 year; 93% of patients completed ambulatory BP monitoring during hospitalization and 94.7% finished a 3-month BP diary. Conclusion The BOSS registry will provide important evidence about BP management in the acute phase and secondary prevention for IS/TIA patients. PMID:27942205

  9. Baseline characteristics and treatment of patients in Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF)

    PubMed Central

    McMurray, John J V; Packer, Milton; Desai, Akshay S; Gong, Jianjian; Lefkowitz, Martin; Rizkala, Adel R; Rouleau, Jean L; Shi, Victor C; Solomon, Scott D; Swedberg, Karl; Zile, Michael R

    2014-01-01

    Aim To describe the baseline characteristics and treatment of the patients randomized in the PARADIGM-HF (Prospective comparison of ARNi with ACEi to Determine Impact on Global Mortality and morbidity in Heart Failure) trial, testing the hypothesis that the strategy of simultaneously blocking the renin–angiotensin–aldosterone system and augmenting natriuretic peptides with LCZ696 200 mg b.i.d. is superior to enalapril 10 mg b.i.d. in reducing mortality and morbidity in patients with heart failure and reduced ejection fraction. Methods Key demographic, clinical and laboratory findings, along with baseline treatment, are reported and compared with those of patients in the treatment arm of the Studies Of Left Ventricular Dysfunction (SOLVD-T) and more contemporary drug and device trials in heart failure and reduced ejection fraction. Results The mean age of the 8442 patients in PARADIGM-HF is 64 (SD 11) years and 78% are male, which is similar to SOLVD-T and more recent trials. Despite extensive background therapy with beta-blockers (93% patients) and mineralocorticoid receptor antagonists (60%), patients in PARADIGM-HF have persisting symptoms and signs, reduced health related quality of life, a low LVEF (mean 29 ± SD 6%) and elevated N-terminal-proB type-natriuretic peptide levels (median 1608 inter-quartile range 886–3221 pg/mL). Conclusion PARADIGM-HF will determine whether LCZ696 is more beneficial than enalapril when added to other disease-modifying therapies and if further augmentation of endogenous natriuretic peptides will reduce morbidity and mortality in heart failure and reduced ejection fraction. PMID:24828035

  10. Pro-HEART - a randomized clinical trial to test the effectiveness of a high protein diet targeting obese individuals with heart failure: rationale, design and baseline characteristics.

    PubMed

    Motie, Marjan; Evangelista, Lorraine S; Horwich, Tamara; Hamilton, Michele; Lombardo, Dawn; Cooper, Dan M; Galassetti, Pietro R; Fonarow, Gregg C

    2013-11-01

    There is ample research to support the potential benefits of a high protein diet on clinical outcomes in overweight/obese, diabetic subjects. However, nutritional management of overweight/obese individuals with heart failure (HF) and type 2 diabetes mellitus (DM) or metabolic syndrome (MS) is poorly understood and few clinical guidelines related to nutritional approaches exist for this subgroup. This article describes the design, methods, and baseline characteristics of study participants enrolled in Pro-HEART, a randomized clinical trial to determine the short term and long term effects of a high protein diet (30% protein [~110 g/day], 40% carbohydrates [150 g/day], 30% fat [~50 g/day]) versus a standard protein diet (15% protein [~55 g/day], 55% carbohydrates [~200 g/day], 30% fat [~50 g/day]) on body weight and adiposity, cardiac structure and function, functional status, lipid profile, glycemic control, and quality of life. Between August, 2009 and May, 2013, 61 individuals agreed to participate in the study; 52 (85%) - mean age 58.2 ± 9.8 years; 15.4% Blacks; 57.7% Whites; 19.2% Hispanics; 7.7% Asians; 73.1% male; weight 112.0 ± 22.6 kg - were randomized to a 3-month intensive weight management program of either a high protein or standard protein diet; data were collected at baseline, 3 months, and 15 months. This study has the potential to reveal significant details about the role of macronutrients in weight management of overweight/obese individuals with HF and DM or MS. © 2013 Elsevier Inc. All rights reserved.

  11. The design, rationale, and baseline characteristics of a nationwide cohort registry in China: blood pressure and clinical outcome in TIA or ischemic stroke.

    PubMed

    Xu, Jie; Liu, Yi; Tao, Yongli; Xie, Xuewei; Gu, Hongqiu; Pan, Yuesong; Zhao, Xingquan; Wang, Yongjun; Yan, Aoshuang; Wang, Yilong

    2016-01-01

    The relationship between poststroke blood pressure (BP) and clinical outcomes in ischemic stroke (IS) is still controversial. However, there is no large BP database for IS or transient ischemic attack (TIA) in China. This study aims to describe the rationale, study design, and baseline characteristics of a nationwide BP database in IS or TIA patients in China. The BOSS (blood pressure and clinical outcome in TIA or ischemic stroke) study was a hospital-based, prospective cohort study aiming to assess BP parameters and clinical outcome in IS/TIA patients. BP parameters were based on office BP, ambulatory BP, and home BP. Clinical outcomes included stroke recurrence, combined vascular events, and disability. Electronic case-report forms were used to record baseline and follow-up data. The patients were followed up for clinical outcomes at 3 months through face-to-face interview and at 12 months by telephone. Between October 2012 and February 2014, the BOSS registry recruited 2,608 patients from 61 hospitals, with a mean age of 62.5 years, 32.4% of whom were female, 88.9% with an entry diagnosis of IS, and 86% diagnosed with hypertension. The rates of patients lost-to-follow-up were 3.1% at 3 months and 5.1% at 1 year; 93% of patients completed ambulatory BP monitoring during hospitalization and 94.7% finished a 3-month BP diary. The BOSS registry will provide important evidence about BP management in the acute phase and secondary prevention for IS/TIA patients.

  12. Baseline characteristics of patients with diabetes and coronary artery disease enrolled in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.

    PubMed

    2008-09-01

    The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial was undertaken to determine whether early revascularization intervention is superior to deferred intervention in the presence of aggressive medical therapy and whether antidiabetes regimens targeting insulin sensitivity are more or less effective than regimens targeting insulin provision in reducing cardiovascular events among patients with type 2 diabetes mellitus and stable coronary artery disease (CAD). The BARI 2D trial is a National Institutes of Health-sponsored randomized clinical trial with a 2 x 2 factorial design. Between 2001 and 2005, 49 clinical sites in North America, South America, and Europe randomized 2,368 patients. At baseline, the trial collected data on clinical history, symptoms, and medications along with centralized evaluations of angiograms, electrocardiograms, and blood and urine specimens. Most of the BARI 2D patients were referred from the cardiac catheterization laboratory (54%) or cardiology clinic (27%). Of the randomized participants, 30% were women, 34% were minorities, 61% had angina, and 67% had multiregion CAD. Moreover, 29% had been treated with insulin, 58% had hemoglobin A(1c) >7.0%, 41% had low-density lipoprotein cholesterol >or=100 mg/dL, 52% had blood pressure >130/80 mm Hg, and 56% had body mass index >or=30 kg/m(2). Baseline characteristics in BARI 2D are well balanced between the randomized treatment groups, and the clinical profile of the study cohort is representative of the target population. As a result, the BARI 2D clinical trial is in an excellent position to evaluate alternative treatment approaches for diabetes and CAD.

  13. Testing the comparative effects of physical activity advice by humans vs. computers in underserved populations: The COMPASS trial design, methods, and baseline characteristics.

    PubMed

    King, Abby C; Campero, Ines; Sheats, Jylana L; Castro Sweet, Cynthia M; Garcia, Dulce; Chazaro, Aldo; Blanco, German; Hauser, Michelle; Fierros, Fernando; Ahn, David K; Diaz, Jose; Done, Monica; Fernandez, Juan; Bickmore, Timothy

    2017-10-01

    While physical inactivity is a key risk factor for a range of chronic diseases and conditions associated with aging, a significant proportion of midlife and older adults remain insufficiently active. This is particularly true for ethnic minority populations such as Latino adults for whom few culturally adapted programs have been developed and tested. The major objective of this 12-month cluster-randomized controlled trial is to test the comparative effectiveness of two linguistically and culturally adapted, community-based physical activity interventions with the potential for broad reach and translation. Ten local community centers serving a sizable number of Latino residents were randomized to receive one of two physical activity interventions. The Virtual Advisor program employs a computer-based embodied conversational agent named "Carmen" to deliver interactive, individually tailored physical activity advice and support. A similar intervention program is delivered by trained Peer Advisors. The target population consists of generally healthy, insufficiently active Latino adults ages 50years and older living within proximity to a designated community center. The major outcomes are changes in walking and other forms of physical activity measured via self-report and accelerometry. Secondary outcomes include physical function and well-being variables. In addition to these outcome analyses, comparative cost analysis of the two programs, potential mediators of intervention success, and baseline moderators of intervention effects will be explored to better determine which subgroups do best with which type of intervention. Here we present the study design and methods, including recruitment strategies and yield as well as study baseline characteristics. clinicaltrial.gov Identifier=NCT02111213. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Effect of Baseline Characteristics on the Outcome of Stent Retriever-Based Thrombectomy in Acute Basilar Artery Occlusions: A Single-Center Experience and Pooled Data Analysis.

    PubMed

    Wen, Wan-Ling; Li, Zi-Fu; Zhang, Yong-Wei; Yang, Peng-Fei; Simfukwe, Keith; Fang, Yi-Bin; Zhang, Tian-Yi; Deng, Ben-Qiang; Hong, Bo; Liu, Jian-Min; Huang, Qing-Hai

    2017-08-01

    To explore the association of baseline characteristics and the outcome of patients with acute basilar artery occlusion (BAO) after stent retriever-based thrombectomy (SRT). Clinical and imaging information of consecutive SRT-treated patients with BAO from a comprehensive stroke center and up-to-date literature were reviewed respectively. The impact of baseline variables toward favorable outcome was evaluated using subgroup analysis and odds ratio (OR) extracted from published data together with single-center records using pooled analysis. Nineteen cases from our center and 15 published studies involving 487 cases were included. Estimated pooled favorable outcome rate was 0.3746 (95% confidence interval [CI], 0.3165-0.4327), mortality was 0.2950 (95% CI, 0.2390-0.3510). Pooled estimates showed that successful reperfusion (modified thrombolysis in cerebral ischemia scale 2b or 3) gained by SRT alone was 0.7317 (95% CI, 0.6532-0.8102) and final successful reperfusion rate with or without additional reperfusion procedures was 0.8834 (95% CI, 0.8279-0.9390). Univariate analysis indicated that patients with successful reperfusion (OR, 2.05; P = 0.05), distal segment occlusion (OR, 2.03; P = 0.03), and cardioembolus origin (OR, 2.13; P = 0.01) were more likely to have favorable outcome (modified Rankin Scale score ≤2 at 3 months). Study series that applied intra-arterial thrombolysis, angioplasty, or stenting as rescuing therapy had higher successful reperfusion rate but they did not show a higher rate of favorable outcome. SRT with or without additional treatment appeared to be effective for the treatment of BAO. Successful reperfusion, distal segment occlusion, and cardiac embolism were associated with favorable outcome. The overall benefit of lesions requiring additional reperfusion therapy was unclear. Copyright © 2017 Elsevier Inc. All rights reserved.

  15. Baseline characteristics and treatment of patients in prospective comparison of ARNI with ACEI to determine impact on global mortality and morbidity in heart failure trial (PARADIGM-HF).

    PubMed

    McMurray, John J V; Packer, Milton; Desai, Akshay S; Gong, Jianjian; Lefkowitz, Martin; Rizkala, Adel R; Rouleau, Jean L; Shi, Victor C; Solomon, Scott D; Swedberg, Karl; Zile, Michael R

    2014-07-01

    To describe the baseline characteristics and treatment of the patients randomized in the PARADIGM-HF (Prospective comparison of ARNi with ACEi to Determine Impact on Global Mortality and morbidity in Heart Failure) trial, testing the hypothesis that the strategy of simultaneously blocking the renin-angiotensin-aldosterone system and augmenting natriuretic peptides with LCZ696 200 mg b.i.d. is superior to enalapril 10 mg b.i.d. in reducing mortality and morbidity in patients with heart failure and reduced ejection fraction. Key demographic, clinical and laboratory findings, along with baseline treatment, are reported and compared with those of patients in the treatment arm of the Studies Of Left Ventricular Dysfunction (SOLVD-T) and more contemporary drug and device trials in heart failure and reduced ejection fraction. The mean age of the 8442 patients in PARADIGM-HF is 64 (SD 11) years and 78% are male, which is similar to SOLVD-T and more recent trials. Despite extensive background therapy with beta-blockers (93% patients) and mineralocorticoid receptor antagonists (60%), patients in PARADIGM-HF have persisting symptoms and signs, reduced health related quality of life, a low LVEF (mean 29 ± SD 6%) and elevated N-terminal-proB type-natriuretic peptide levels (median 1608 inter-quartile range 886-3221 pg/mL). PARADIGM-HF will determine whether LCZ696 is more beneficial than enalapril when added to other disease-modifying therapies and if further augmentation of endogenous natriuretic peptides will reduce morbidity and mortality in heart failure and reduced ejection fraction. © 2014 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

  16. [Comparative study of postprandial glycaemia in type 2 diabetic patients after consumption of mono- and disaccharides and sweeteners].

    PubMed

    Sharafetdinov, Kh Kh; Meshcheriakova, V A; Plotnikova, O A; Gapparov, M G

    2002-01-01

    It was investigated the influence of mono- and disaccharides, sugar alcohols, honey, corn patoka and products with nutritive and nonnutritive sweeteners on dynamic of postprandial glycaemia in type 2 diabetic patients. After ingestion of 30 g fructose, blood glucose did not show a marked increase in comparison with sucrose or honey. After ingestion of 30 g sorbitol or isomalt, blood glucose curve was not significantly different. It was indicated that corn patoka in chewing candies with isomalt has a high hyperglycaemic effect whereas drink with nonnutritive sweeteners did not change blood glucose from fasting levels.

  17. The Pap smear screening as an occasion for smoking cessation and physical activity counselling: baseline characteristics of women involved in the SPRINT randomized controlled trial.

    PubMed

    Chellini, Elisabetta; Gorini, Giuseppe; Carreras, Giulia; Giordano, Livia; Anghinoni, Emanuela; Iossa, Anna; Bellati, Cristina; Grechi, Elisa; Coppo, Alessandro; Talassi, Fiorella; Giovacchini, Maria Rosa

    2011-12-07

    Gender-specific smoking cessation strategies have rarely been developed. Evidence of effectiveness of physical activity (PA) promotion and intervention in adjunct to smoking cessation programs is not strong. SPRINT study is a randomized controlled trial (RCT) designed to evaluate a counselling intervention on smoking cessation and PA delivered to women attending the Italian National Health System Cervical Cancer Screening Program. This paper presents study design and baseline characteristics of the study population. Among women undergoing the Pap examination in three study centres (Florence, Turin, Mantua), participants were randomized to the smoking cessation counselling [S], the smoking cessation + PA counselling [S + PA], or the control [C] groups. The program under evaluation is a standard brief counselling on smoking cessation combined with a brief counselling on increasing PA, and was delivered in 2010. A questionnaire, administered before, after 6 months and 1 year from the intervention, was used to track behavioural changes in tobacco use and PA, and to record cessation rates in participants. Out of the 5,657 women undergoing the Pap examination, 1,100 participants (55% of smokers) were randomized in 1 of the 3 study groups (363 in the S, 366 in the S + PA and 371 in the C groups). The three arms did not differ on any demographic, PA, or tobacco-use characteristics. Recruited smokers were older, less educated than non-participant women, more motivated to quit (33% vs.9% in the Preparation stage, p < 0.001), smoked more cigarettes per day (12 vs.9, p < 0.001), and were more likely to have already done 1 or more quit attempts (64% vs.50%, p < 0.001). The approach of SPRINT study appeared suitable to enrol less educated women who usually smoke more and have more difficulties to quit. ISRCTN: ISRCTN52660565.

  18. Baseline Cardiovascular Characteristics of Adult Patients with Chronic Kidney Disease from the KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD).

    PubMed

    Kim, Hyoungnae; Yoo, Tae Hyun; Choi, Kyu Hun; Oh, Kook Hwan; Lee, Joongyub; Kim, Soo Wan; Kim, Tae Hee; Sung, Suah; Han, Seung Hyeok

    2017-02-01

    Cardiovascular disease (CVD) is the most common cause of death in patients with chronic kidney disease (CKD). We report the baseline cardiovascular characteristics of 2,238 participants by using the data of the KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD) study. The cohort comprises 5 subcohorts according to the cause of CKD: glomerulonephritis (GN), diabetic nephropathy (DN), hypertensive nephropathy (HTN), polycystic kidney disease (PKD), and unclassified. The average estimated glomerular filtration rate (eGFR) was 50.5 ± 30.3 mL/min⁻¹/1.73 m⁻² and lowest in the DN subcohort. The overall prevalence of previous CVD was 14.4% in all patients, and was highest in the DN followed by that in the HTN subcohort. The DN subcohort had more adverse cardiovascular risk profiles (higher systolic blood pressure [SBP], and higher levels of cardiac troponin T, left ventricular mass index [LVMI], coronary calcium score, and brachial-ankle pulse wave velocity [baPWV]) than the other subcohorts. The HTN subcohort exhibited less severe cardiovascular risk profiles than the DN subcohort, but had more severe cardiovascular risk features than the GN and PKD subcohorts. All these cardiovascular risk profiles were inversely correlated with eGFR. In conclusion, this study shows that the KNOW-CKD cohort exhibits high cardiovascular burden, as other CKD cohorts in previous studies. Among the subcohorts, the DN subcohort had the highest risk for CVD. The ongoing long-term follow-up study up to 10 years will further delineate cardiovascular characteristics and outcomes of each subcohort exposed to different risk profiles.

  19. Baseline Cardiovascular Characteristics of Adult Patients with Chronic Kidney Disease from the KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD)

    PubMed Central

    2017-01-01

    Cardiovascular disease (CVD) is the most common cause of death in patients with chronic kidney disease (CKD). We report the baseline cardiovascular characteristics of 2,238 participants by using the data of the KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD) study. The cohort comprises 5 subcohorts according to the cause of CKD: glomerulonephritis (GN), diabetic nephropathy (DN), hypertensive nephropathy (HTN), polycystic kidney disease (PKD), and unclassified. The average estimated glomerular filtration rate (eGFR) was 50.5 ± 30.3 mL/min−1/1.73 m−2 and lowest in the DN subcohort. The overall prevalence of previous CVD was 14.4% in all patients, and was highest in the DN followed by that in the HTN subcohort. The DN subcohort had more adverse cardiovascular risk profiles (higher systolic blood pressure [SBP], and higher levels of cardiac troponin T, left ventricular mass index [LVMI], coronary calcium score, and brachial-ankle pulse wave velocity [baPWV]) than the other subcohorts. The HTN subcohort exhibited less severe cardiovascular risk profiles than the DN subcohort, but had more severe cardiovascular risk features than the GN and PKD subcohorts. All these cardiovascular risk profiles were inversely correlated with eGFR. In conclusion, this study shows that the KNOW-CKD cohort exhibits high cardiovascular burden, as other CKD cohorts in previous studies. Among the subcohorts, the DN subcohort had the highest risk for CVD. The ongoing long-term follow-up study up to 10 years will further delineate cardiovascular characteristics and outcomes of each subcohort exposed to different risk profiles. PMID:28049233

  20. The Pap smear screening as an occasion for smoking cessation and physical activity counselling: baseline characteristics of women involved in the SPRINT randomized controlled trial

    PubMed Central

    2011-01-01

    Background Gender-specific smoking cessation strategies have rarely been developed. Evidence of effectiveness of physical activity (PA) promotion and intervention in adjunct to smoking cessation programs is not strong. SPRINT study is a randomized controlled trial (RCT) designed to evaluate a counselling intervention on smoking cessation and PA delivered to women attending the Italian National Health System Cervical Cancer Screening Program. This paper presents study design and baseline characteristics of the study population. Methods/Design Among women undergoing the Pap examination in three study centres (Florence, Turin, Mantua), participants were randomized to the smoking cessation counselling [S], the smoking cessation + PA counselling [S + PA], or the control [C] groups. The program under evaluation is a standard brief counselling on smoking cessation combined with a brief counselling on increasing PA, and was delivered in 2010. A questionnaire, administered before, after 6 months and 1 year from the intervention, was used to track behavioural changes in tobacco use and PA, and to record cessation rates in participants. Discussion Out of the 5,657 women undergoing the Pap examination, 1,100 participants (55% of smokers) were randomized in 1 of the 3 study groups (363 in the S, 366 in the S + PA and 371 in the C groups). The three arms did not differ on any demographic, PA, or tobacco-use characteristics. Recruited smokers were older, less educated than non-participant women, more motivated to quit (33% vs.9% in the Preparation stage, p < 0.001), smoked more cigarettes per day (12 vs.9, p < 0.001), and were more likely to have already done 1 or more quit attempts (64% vs.50%, p < 0.001). The approach of SPRINT study appeared suitable to enrol less educated women who usually smoke more and have more difficulties to quit. Trial registration number ISRCTN: ISRCTN52660565 PMID:22151834

  1. Characteristics and associated factors of Klee cartilage lesions: preliminary baseline-data of more than 1000 patients from the German cartilage registry (KnorpelRegister DGOU).

    PubMed

    Spahn, Gunter; Fritz, Jürgen; Albrecht, Dirk; Hofmann, Gunther O; Niemeyer, Philipp

    2016-06-01

    Knee cartilage lesions are very frequent in arthroscopic surgery. This multi-center-study was aimed to evaluate the distribution and possible associated factors of these pathologies in more than 1000 patients. The German cartilage registry (KnorpelRegister DGOU) started in 2013. In this paper, we present the baseline-data (distribution of knee cartilage lesions and the demographic data) of more than 1000 cases since the registries' start-up. A total number of 47 centers were involved into this multicenter study. A total of 1071 patients primary were registered. Degenerative knees 629 times (61.8 %) and injured knees 302 times (29.6 %) were involved. In the remaining 89 knees (8.7 %) the genesis of cartilage lesions was unclear. Single defects were observed in 792 cases (77.6 %). Most frequently the medial femoral condyle or the patella was affected. In 78 knees (7.6 %) the main-defect was associated with a defect of the corresponding joint surface. In the remaining cases complex cartilage damages were found. Our results are in confirmation with other multicenter studies. But these former studies did not differentiate into traumatic and degenerative lesions. Furthermore no characteristics were given regarding to single, kissing or complex lesions. Thus this database will be a sufficient instrument for the investigation of the "natural course" of cartilage lesions, but above all about the effectiveness of different treatment options.

  2. The ICTUS Study: A Prospective longitudinal observational study of 1,380 AD patients in Europe. Study design and baseline characteristics of the cohort.

    PubMed

    Reynish, E; Cortes, F; Andrieu, S; Cantet, C; Olde Rikkert, M; Melis, R; Froelich, L; Frisoni, G B; Jönsson, L; Visser, P J; Ousset, P J; Vellas, B

    2007-01-01

    The long-term objective of the ICTUS study is to identify milestones in Alzheimer's disease (AD) progression and to develop a model to predict disease course in individual AD patients in Europe. The secondary objectives are to describe the patterns of prescribing, and the socioeconomic impact of AD in Europe. Between 2003 and 2005 1,380 patients with probable AD were recruited in specialised (secondary care) clinics in 12 European countries. Their mean age was 76 years and they had a mean of 8.0 +/- (SD) 4.6 years of education. Thirty-five percent were male. The mean MMSE score was 20.4 +/- (SD) 4.0. Forty-three percent had very mild dementia (CDR 0.5) and 44% had mild dementia (CDR 1). All patients completed baseline evaluation and biannual follow-up is ongoing. The goals of the current study are to describe the specific methods for recruitment in this crosscultural setting and the characteristics of the inception ICTUS cohort, including clinical features, co-morbidity, neuropsychological performance, neuropsychiatric symptoms, functional impairment and social burden. (c) 2007 S. Karger AG, Basel.

  3. Early intervention programme for patients with psychotic disorders in "Sveti Ivan" Psychiatric hospital (RIPEPP) - sociodemographic and baseline characteristics of the participants.

    PubMed

    Restek-Petrović, Branka; Majdančić, Ana; Molnar, Sven; Grah, Majda; Ivezić, Ena; Filipčić, Igor; Bogović, Anamarija; Grošić, Vladimir; Mayer, Nina; Kezić, Slobodanka; Pavlović, Irena

    2017-06-01

    Psychiatric hospital "Sveti Ivan" in Zagreb, Croatia, offers an outpatient Early intervention programme for patients with psychotic disorders (RIPEPP), consisting of psychoeducational workshops and group psychodynamic psychotherapy. The aim of this study was to describe sociodemographic and baseline characteristics of the participants, in order to provide better understanding of this population, and to assist with the development of more effective therapeutic approaches. Since 2008, a total of 245 patients with first episodes of psychosis and their family members participated in the programme. They filled out several questionnaires within the framework of the programme evaluation, but for the purposes of this study, only data collected on sociodemographic questionnaire and the Health of the Nation Outcome Scales (HoNOS) are presented. Majority of the participants were male (66%), at the average age of 28 (SD=6.6), living with their parents (73.5%). Most of them finished secondary school (45.7%) but almost a quarter of the sample (23.7%) is currently studying at university. The average duration of untreated period was 101.60 days, with a median of 30 days. According to results of HONOS questionnaire, upon entry into the programme, the patients most often listed cognitive functioning (attention, concentration, memory) and professional issues (performance of work tasks and activities tied to work) as the most problematic areas. The findings of this study provide more detailed description of the beneficiaries of the RIPEPP programme, which can contribute to forming future programmes for the prevention of psychotic disorders.

  4. Glycaemia Status, Lipid Profile and Renal Parameters in Progressive Diabetic Neuropathy

    PubMed Central

    Mohapatra, Debahuti

    2016-01-01

    Introduction Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes. Existence of systemic co-morbidities in DPN patients has not been studied much, especially in Indian population. Aim To evaluate glycaemic status, lipid profile, renal parameters and blood count to assess occurrence of co-morbidities as severity of DPN progresses. Materials and Methods A case control study involving 104 DPN patients and 43 controls of age 31-70years were selected. Patients were categorized into stage 0, 1, 2 and 3 of severity as per Dyck system of classification. Fasting Blood Sugar (FBS), Post Prandial Blood Sugar (PPBS), Glycosylated haemoglobin (HbA1c), Lipid profile, Vitamin B12, Thyroid Stimulating Hormone, Urea, Creatinine and Complete blood counts were assessed along with baseline characteristics. Results Glycosylated haemoglobin was in uncontrolled range for DPN patients (9.03±2.09) FBS and PPBS were significantly more with progress of severity of DPN (p<0.001). HDL decreased (p<0.001) as severity progressed and Triglyceride increased in DPN cases. Mean urea values increased (p=0.008) while haemoglobin levels and RBC count decreased (p<0.001) as severity of DPN progressed. Conclusion Abnormal lipid profile, increased urea and decreased RBC levels point to co-existence of cardiovascular and renal comorbidities as severity of DPN progressed. PMID:27790428

  5. Primary prevention of childhood obesity through counselling sessions at Swedish child health centres: design, methods and baseline sample characteristics of the PRIMROSE cluster-randomised trial.

    PubMed

    Döring, Nora; Hansson, Lena M; Andersson, Elina Scheers; Bohman, Benjamin; Westin, Maria; Magnusson, Margaretha; Larsson, Christel; Sundblom, Elinor; Willmer, Mikaela; Blennow, Margareta; Heitmann, Berit L; Forsberg, Lars; Wallin, Sanna; Tynelius, Per; Ghaderi, Ata; Rasmussen, Finn

    2014-04-09

    Childhood obesity is a growing concern in Sweden. Children with overweight and obesity run a high risk of becoming obese as adults, and are likely to develop comorbidities. Despite the immense demand, there is still a lack of evidence-based comprehensive prevention programmes targeting pre-school children and their families in primary health care settings. The aims are to describe the design and methodology of the PRIMROSE cluster-randomised controlled trial, assess the relative validity of a food frequency questionnaire, and describe the baseline characteristics of the eligible young children and their mothers. The PRIMROSE trial targets first-time parents and their children at Swedish child health centres (CHC) in eight counties in Sweden. Randomisation is conducted at the CHC unit level. CHC nurses employed at the participating CHC received training in carrying out the intervention alongside their provision of regular services. The intervention programme, starting when the child is 8-9 months of age and ending at age 4, is based on social cognitive theory and employs motivational interviewing. Primary outcomes are children's body mass index and waist circumference at four years. Secondary outcomes are children's and mothers' eating habits (assessed by a food frequency questionnaire), and children's and mothers' physical activity (measured by accelerometer and a validated questionnaire), and mothers' body mass index and waist circumference. The on-going population-based PRIMROSE trial, which targets childhood obesity, is embedded in the regular national (routine) preventive child health services that are available free-of-charge to all young families in Sweden. Of the participants (n = 1369), 489 intervention and 550 control mothers (75.9%) responded to the validated physical activity and food frequency questionnaire at baseline (i.e., before the first intervention session, or, for children in the control group, before they reached 10 months of age). The

  6. Primary prevention of childhood obesity through counselling sessions at Swedish child health centres: design, methods and baseline sample characteristics of the PRIMROSE cluster-randomised trial

    PubMed Central

    2014-01-01

    Background Childhood obesity is a growing concern in Sweden. Children with overweight and obesity run a high risk of becoming obese as adults, and are likely to develop comorbidities. Despite the immense demand, there is still a lack of evidence-based comprehensive prevention programmes targeting pre-school children and their families in primary health care settings. The aims are to describe the design and methodology of the PRIMROSE cluster-randomised controlled trial, assess the relative validity of a food frequency questionnaire, and describe the baseline characteristics of the eligible young children and their mothers. Methods/Design The PRIMROSE trial targets first-time parents and their children at Swedish child health centres (CHC) in eight counties in Sweden. Randomisation is conducted at the CHC unit level. CHC nurses employed at the participating CHC received training in carrying out the intervention alongside their provision of regular services. The intervention programme, starting when the child is 8-9 months of age and ending at age 4, is based on social cognitive theory and employs motivational interviewing. Primary outcomes are children’s body mass index and waist circumference at four years. Secondary outcomes are children’s and mothers’ eating habits (assessed by a food frequency questionnaire), and children’s and mothers’ physical activity (measured by accelerometer and a validated questionnaire), and mothers’ body mass index and waist circumference. Discussion The on-going population-based PRIMROSE trial, which targets childhood obesity, is embedded in the regular national (routine) preventive child health services that are available free-of-charge to all young families in Sweden. Of the participants (n = 1369), 489 intervention and 550 control mothers (75.9%) responded to the validated physical activity and food frequency questionnaire at baseline (i.e., before the first intervention session, or, for children in the control

  7. Baseline geochemical characteristics of groundwater in the mountainous area of Jeju Island, South Korea: Implications for degree of mineralization and nitrate contamination

    NASA Astrophysics Data System (ADS)

    Koh, Dong-Chan; Chae, Gi-Tak; Yoon, Yoon-Yeol; Kang, Bong-Rae; Koh, Gi-Won; Park, Ki-Hwa

    2009-09-01

    SummaryHydrogeochemical characteristics of groundwater were investigated to elucidate baseline quality for basaltic aquifers of a mountainous area dominated by natural land cover in the volcanic island of Jeju, South Korea. Principal component analysis (PCA) resulted in four principal components (PC) of which PC1, PC3 and PC4 represented natural mineralization by water-rock interaction, while PC2 corresponded to anthropogenic contamination from nitrate sources. Hierarchical cluster analysis (HCA) was performed to assess the effect of the geochemical and hydrologic processes on each sample. Six sample groups, distinguished by total dissolved solids (TDS), nitrate concentration, and water type, resulted from the HCA: high-altitude springs, low-mineral water, nitrate-contaminated water, intermediate-mineral water, and two groups of high-mineral water. Water types were transformed from Na(Mg, Ca)-HCO 3 for low-mineral water to Na-HCO 3 for high-mineral water. Nitrate-contaminated water occurred near the boundary of natural and agricultural land uses of the western area. High-mineral water had higher calcite saturation states than other groups. The high-mineral water also had tritium ( 3H) values lower than 1.5 TU, indicating a significant contribution of old groundwater. In contrast, low-mineral water had tritium values of about 3 TU, which is close to those of rainwater. Geographically, the high-mineral water was concentrated in the southwestern area, where intermediate-mineral water was also found. This distribution was likely related to the presence of extensive trachytic rocks, which could have formed locally isolated aquifers, enabling prolonged water-rock interactions; the higher location of low-permeability hydrovolcanic tuffs in the subsurface of the southern area would also increase chances of tapping aquifers below the hydrovolcanic tuffs. The cumulative probability of TDS showed two breakpoints of 50 and 150 mg/L that distinguished high-altitude springs, low

  8. EFFECTS OF TRAINING AND DETRAINING ON GLYCOSYLATED HAEMOGLOBIN, GLYCAEMIA AND LIPID PROFILE IN TYPE-II DIABETICS.

    PubMed

    Yuing Farias, Tuillang; Santos-Lozano, Alejandro; Solís Urra, Patricio; Cristi-Montero, Carlos

    2015-10-01

    the aim of the present study was to determine the effect of training and the consequences of detraining, comparing an aerobic training (AT) protocol with a resistance training (RT) in people with type-II Diabetes Mellitus (DMII). a total of 30 individuals participated in the study, with ages ranging from 45 to 50 years, all diagnosed with DMII and not currently receiving pharmacological treatment. Participants were divided at random into an AT group (65% of their maximum aerobic capacity) and a RT group (1 x 2 x 3 protocol at 65% of 1RM). Measurements were taken of weight, body mass index, total cholesterol, HDL-C, LDL-C, triglycerides, glycaemia in a fasted state and glycosylated haemoglobin (HbA1C) at the beginning and at the end of the 6-week training period, and after a further 6 weeks of detraining. the results show that both physical training protocols are capable of inducing significant modifications in lipid profile, glycaemia in a fasted state and levels of HbA1C; however, after stopping the training programme only the RT group maintained the benefits of the reduction in LDL-C, HbA1C and the increase in HDL-C. resistance exercise in individuals with DMII has an important influence on health and their effects could be maintained even if the training program is interrupted short-term. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  9. Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial.

    PubMed

    Sabatine, Marc S; Leiter, Lawrence A; Wiviott, Stephen D; Giugliano, Robert P; Deedwania, Prakash; De Ferrari, Gaetano M; Murphy, Sabina A; Kuder, Julia F; Gouni-Berthold, Ioanna; Lewis, Basil S; Handelsman, Yehuda; Pineda, Armando Lira; Honarpour, Narimon; Keech, Anthony C; Sever, Peter S; Pedersen, Terje R

    2017-09-14

    The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab reduced LDL cholesterol and cardiovascular events in the FOURIER trial. In this prespecified analysis of FOURIER, we investigated the efficacy and safety of evolocumab by diabetes status and the effect of evolocumab on glycaemia and risk of developing diabetes. FOURIER was a randomised trial of evolocumab (140 mg every 2 weeks or 420 mg once per month) versus placebo in 27 564 patients with atherosclerotic disease who were on statin therapy, followed up for a median of 2·2 years. In this prespecified analysis, we investigated the effect of evolocumab on cardiovascular events by diabetes status at baseline, defined on the basis of patient history, clinical events committee review of medical records, or baseline HbA1c of 6·5% (48 mmol/mol) or greater or fasting plasma glucose (FPG) of 7·0 mmol/L or greater. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, hospital admission for unstable angina, or coronary revascularisation. The key secondary endpoint was a composite of cardiovascular death, myocardial infarction, or stroke. We also assessed the effect of evolocumab on glycaemia, and on the risk of new-onset diabetes among patients without diabetes at baseline. HbA1c was measured at baseline then every 24 weeks and FPG was measured at baseline, week 12, week 24, and every 24 weeks thereafter, and potential cases of new-onset diabetes were adjudicated centrally. In a post-hoc analysis, we also investigated the effects on glycaemia and diabetes risk in patients with prediabetes (HbA1c 5·7-6·4% [39-46 mmol/mol] or FPG 5·6-6·9 mmol/L) at baseline. FOURIER is registered with ClinicalTrials.gov, number NCT01764633. At study baseline, 11 031 patients (40%) had diabetes and 16 533 (60%) did not have diabetes (of whom 10 344 had prediabetes and 6189 had normoglycaemia). Evolocumab significantly reduced cardiovascular outcomes consistently

  10. The JDRF CCTN CGM TIME Trial: Timing of Initiation of continuous glucose Monitoring in Established pediatric type 1 diabetes: study protocol, recruitment and baseline characteristics.

    PubMed

    Lawson, Margaret L; Bradley, Brenda; McAssey, Karen; Clarson, Cheril; Kirsch, Susan E; Mahmud, Farid H; Curtis, Jacqueline R; Richardson, Christine; Courtney, Jennilea; Cooper, Tammy; Downie, Cynthia J; Rajamannar, Gopalan; Barrowman, Nicholas

    2014-07-18

    Continuous glucose monitoring (CGM) has been shown to improve glucose control in adults with type 1 diabetes. Effectiveness of CGM is directly linked with CGM adherence, which can be challenging to maintain in children and adolescents. We hypothesize that initiating CGM at the same time as starting insulin pump therapy in pump naïve children and adolescents with type 1 diabetes will result in greater CGM adherence and effectiveness compared to delaying CGM introduction by 6 months, and that this is related to greater readiness for making behaviour change at the time of pump initiation. The CGM TIME Trial is a multicenter randomized controlled trial. Eligible children and adolescents (5-18 years) with established type 1 diabetes were randomized to simultaneous initiation of pump (Medtronic Veo©) and CGM (Enlite©) or to standard pump therapy with delayed CGM introduction. Primary outcomes are CGM adherence and hemoglobin A1C at 6 and 12 months post pump initiation. Secondary outcomes include glycemic variability, stage of readiness, and other patient-reported outcomes with follow-up to 24 months. 144 (95%) of the 152 eligible patients were enrolled and randomized. Allowing for 10% withdrawals, this will provide 93% power to detect a between group difference in CGM adherence and 86% power to detect a between group difference in hemoglobin A1C. Baseline characteristics were similar between the treatment groups. Analysis of 12 month primary outcomes will begin in September 2014. The CGM TIME Trial is the first study to examine the relationship between timing of CGM initiation, readiness for behaviour change, and subsequent CGM adherence in pump naïve children and adolescents. Its findings will advance our understanding of when and how to initiate CGM in children and adolescents with type 1 diabetes. ClinicalTrial.gov NCT01295788. Registered 14 February 2011.

  11. [Baseline characteristics and clinical management of the first 3,000 patients enrolled in the IBERICAN study (Identification of the Spanish population at cardiovascular and renal risk)].

    PubMed

    Cinza Sanjurjo, Sergio; Prieto Díaz, Miguel Ángel; Llisterri Caro, José Luis; Pallarés Carratalá, Vicente; Barquilla García, Alfonso; Rodríguez Padial, Luis; Díaz Rodríguez, Ángel; Polo García, José; Vergara Martín, Jesús; Vidal Pérez, Rafael; Rodríguez Roca, Gustavo Cristóbal

    2016-08-23

    To determine the prevalence and incidence of cardiovascular risk factors in Spain, as well as cardiovascular events, in Spanish adult population attended in primary care. IBERICAN is a longitudinal, observational, multicenter study in which patients aged 18 to 85years attended in primary care health center in Spain are being included. The obtained cohort will be followed annually for at least 5years. The estimated final sample is 7,000 patients. The baseline characteristics of the second cut (n=3,042) are presented. The mean age of the subjects included is 57.9±14.6 years, and 55.5% are women. 54.9% live in urban habitat, and 57.3% have primary education. 50.3% had dyslipidemia, 47.4% hypertension, 29.7% physical inactivity, 28.2% abdominal obesity and 19% diabetes mellitus. The degree of control of hypertension, dyslipidemia and type2 diabetes was 58.5%, 25.8% and 75.9%. 28.2% have criteria for metabolic syndrome. 15.6% of patients had previous cardiovascular disease. 7.8% have a history of coronary heart disease, a glomerular filtration rate <60ml/min (CKD-EPI) 8.4%, microalbuminuria 9.6%, atrial fibrillation 5.5%, stroke 4.6%, and heart failure 2.9%. Although the population treated in primary care is relatively young, the high prevalence of risk factors, their poor control and the existence of previous cardiovascular disease will determine the impact on the prognosis of the cohort. Copyright © 2016 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

  12. The EuroPrevall birth cohort study on food allergy: baseline characteristics of 12,000 newborns and their families from nine European countries.

    PubMed

    McBride, D; Keil, T; Grabenhenrich, L; Dubakiene, R; Drasutiene, G; Fiocchi, A; Dahdah, L; Sprikkelman, A B; Schoemaker, A A; Roberts, G; Grimshaw, K; Kowalski, M L; Stanczyk-Przyluska, A; Sigurdardottir, S; Clausen, M; Papadopoulos, N G; Mitsias, D; Rosenfeld, L; Reche, M; Pascual, C; Reich, A; Hourihane, J; Wahn, U; Mills, E N C; Mackie, A; Beyer, K

    2012-05-01

    It is unclear why some children develop food allergy. The EuroPrevall birth cohort was established to examine regional differences in the prevalence and risk factors of food allergy in European children using gold-standard diagnostic criteria. The aim of this report was to describe pre-, post-natal and environmental characteristics among the participating countries. In nine countries across four major European climatic regions, mothers and their newborns were enrolled from October 2005 through February 2010. Using standardized questionnaires, we assessed allergic diseases and self-reported food hypersensitivity of parents and siblings, nutrition during pregnancy, nutritional supplements, medications, mode of delivery, socio-demographic data and home environmental exposures. A total of 12,049 babies and their families were recruited. Self-reported adverse reactions to food ever were considerably more common in mothers from Germany (30%), Iceland, United Kingdom, and the Netherlands (all 20-22%) compared with those from Italy (11%), Lithuania, Greece, Poland, and Spain (all 5-8%). Prevalence estimates of parental asthma, allergic rhinitis and eczema were highest in north-west (Iceland, UK), followed by west (Germany, the Netherlands), south (Greece, Italy, Spain) and lowest in central and east Europe (Poland, Lithuania). Over 17% of Spanish and Greek children were exposed to tobacco smoke in utero compared with only 8-11% in other countries. Caesarean section rate was highest in Greece (44%) and lowest in Spain (<3%). We found country-specific differences in antibiotic use, pet ownership, type of flooring and baby's mattress. In the EuroPrevall birth cohort study, the largest study using gold-standard diagnostic criteria for food allergy in children worldwide, we found considerable country-specific baseline differences regarding a wide range of factors that are hypothesized to play a role in the development of food allergy including allergic family history

  13. PREFER study: a randomized clinical trial testing treatment preference and two dietary options in behavioral weight management--rationale, design and baseline characteristics.

    PubMed

    Burke, Lora E; Choo, Jina; Music, Edvin; Warziski, Melanie; Styn, Mindi A; Kim, Yookyung; Sevick, Mary Ann

    2006-02-01

    Obesity, a disorder associated with a myriad of comorbidities, is increasing at an alarming rate around the world. Given that pharmacotherapy has limited available options and that bariatric surgery is reserved for those who are morbidly obese or who have significant comorbidities, the most common approach to the treatment of obesity is standard behavioral treatment. This approach includes behavior modification related to eating and activity habits. The purpose of this paper is to describe the rationale, design, methods and baseline sample characteristics of a randomized controlled trial of a behavioral intervention in weight loss management, referred to as the PREFER study. The PREFER study, using a four-group design, includes: (1) a randomization scheme that permits participants to indicate a preferred dietary treatment approach, and (2) two dietary options, one of which is a lacto-ovo-vegetarian diet that has demonstrated potential for long-term adherence. The intervention (32 treatment sessions) is delivered over 12 months and is followed by a 6-month maintenance phase; final assessment occurs at 18 months. We screened 932 individuals and randomized 197 to the study: Treatment Preference-Yes (n=84) and Treatment Preference-No (n=98). To maintain a balance across the four treatment groups, 15 subjects who preferred the standard diet had to be discarded from the Treatment Preference-Yes group. Retention at 18 months for the first of three cohorts was 82%. The PREFER study is a single center study and is the first randomized controlled trial examining a lacto-ovo-vegetarian diet as part of weight loss treatment. The ethnically diverse sample includes males and females with a body mass index of 27 to 43. The study has the potential to make a contribution to understanding the role of treatment preference and the potential of a lacto-ovo-vegetarian diet for long-term weight loss.

  14. Incomplete Reporting of Baseline Characteristics in Clinical Trials: An Analysis of Randomized Controlled Trials and Systematic Reviews Involving Patients with Chronic Low Back Pain

    PubMed Central

    Wertli, Maria M.; Schöb, Manuela; Brunner, Florian; Steurer, Johann

    2013-01-01

    Objective The aim of this study was to evaluate the reporting of relevant prognostic information in a sample of randomized controlled trials (RCTs) that investigated treatments for patients with chronic low back pain (LBP). We also analysed how researchers conducting the meta-analyses and systematic reviews addressed the reporting of relevant prognostic information in RCTs. Methods We searched the Cochrane Database to identify systematic reviews that investigated non-surgical treatments for patients with chronic LBP. The reported prognostic information was then extracted from the RCTs included in the reviews. We used a purpose-defined score to assess the quantity of information reported in the RCTs. We also determined how the authors of systematic reviews addressed the question of comparability of patient populations between RCTs. Results Six systematic reviews met our inclusion criteria, and we analysed 84 RCTs. Based on the scores, the reporting of important prognostic variables was incomplete in almost half of the 84 RCTs. Information regarding patients’ general health, social support, and work-related conditions was rarely reported. Almost half of the studies included in one of the meta-analyses provided insufficient information that did not allow us to determine whether patients in the primary trials were comparable. Conclusions Missing prognostic information potentially threatens the external validity (i.e. the generalizability or applicability) not only of primary studies but also of systematic reviews that investigate treatments for LBP. A detailed description of baseline patient characteristics that includes prognostic information is needed in all RCTs to ensure that clinicians can determine the applicability of the study or review results to their patients. PMID:23505524

  15. The JDRF CCTN CGM TIME Trial: Timing of Initiation of continuous glucose Monitoring in Established pediatric type 1 diabetes: study protocol, recruitment and baseline characteristics

    PubMed Central

    2014-01-01

    Background Continuous glucose monitoring (CGM) has been shown to improve glucose control in adults with type 1 diabetes. Effectiveness of CGM is directly linked with CGM adherence, which can be challenging to maintain in children and adolescents. We hypothesize that initiating CGM at the same time as starting insulin pump therapy in pump naïve children and adolescents with type 1 diabetes will result in greater CGM adherence and effectiveness compared to delaying CGM introduction by 6 months, and that this is related to greater readiness for making behaviour change at the time of pump initiation. Methods/Design The CGM TIME Trial is a multicenter randomized controlled trial. Eligible children and adolescents (5-18 years) with established type 1 diabetes were randomized to simultaneous initiation of pump (Medtronic Veo©) and CGM (Enlite©) or to standard pump therapy with delayed CGM introduction. Primary outcomes are CGM adherence and hemoglobin A1C at 6 and 12 months post pump initiation. Secondary outcomes include glycemic variability, stage of readiness, and other patient-reported outcomes with follow-up to 24 months. 144 (95%) of the 152 eligible patients were enrolled and randomized. Allowing for 10% withdrawals, this will provide 93% power to detect a between group difference in CGM adherence and 86% power to detect a between group difference in hemoglobin A1C. Baseline characteristics were similar between the treatment groups. Analysis of 12 month primary outcomes will begin in September 2014. Discussion The CGM TIME Trial is the first study to examine the relationship between timing of CGM initiation, readiness for behaviour change, and subsequent CGM adherence in pump naïve children and adolescents. Its findings will advance our understanding of when and how to initiate CGM in children and adolescents with type 1 diabetes. Trial registration ClinicalTrial.gov NCT01295788. Registered 14 February 2011. PMID:25034216

  16. The Nightingale study: rationale, study design and baseline characteristics of a prospective cohort study on shift work and breast cancer risk among nurses

    PubMed Central

    2014-01-01

    Background Evidence for the carcinogenicity of shift work in humans is limited because of significant heterogeneity of the results, thus more in-depth research in needed. The Nightingale Study is a nationwide prospective cohort study on occupational exposures and risks of chronic diseases among female nurses and focuses on the potential association between shift work and risk of breast cancer. The study design, methods, and baseline characteristics of the cohort are described. Methods/Design The source population for the cohort comprised 18 to 65 year old women who were registered as having completed training to be a nurse in the nationwide register for healthcare professionals in the Netherlands. Eligible women were invited to complete a web-based questionnaire including full job history, a detailed section on all domains of shift work (shift system, cumulative exposure, and shift intensity) and potential confounding factors, and an informed consent form for linkage with national (disease) registries. Women were also asked to donate toenail clippings as a source of DNA for genetic analyses. Between October 6, 2011 and February 1, 2012, 31% of the 192,931 women who were invited to participate completed the questionnaire, yielding a sample size of 59,947 cohort members. The mean age of the participants was 46.9 year (standard deviation 11.0 years). Toenail clippings were provided by 23,439 participants (39%). Discussion Results from the Nightingale Study will contribute to the scientific evidence of potential shift work-related health risks among nurses and will help develop preventive measures and policy aimed at reducing these risks. PMID:24475944

  17. The study of women, infant feeding and type 2 diabetes after GDM pregnancy and growth of their offspring (SWIFT Offspring study): prospective design, methodology and baseline characteristics.

    PubMed

    Gunderson, Erica P; Hurston, Shanta R; Dewey, Kathryn G; Faith, Myles S; Charvat-Aguilar, Nancy; Khoury, Vicky C; Nguyen, Van T; Quesenberry, Charles P

    2015-07-17

    Breastfeeding is associated with reduced risk of becoming overweight or obese later in life. Breastfed babies grow more slowly during infancy than formula-fed babies. Among offspring exposed in utero to maternal glucose intolerance, prospective data on growth during infancy have been unavailable. Thus, scientific evidence is insufficient to conclude that breastfeeding reduces the risk of obesity among the offspring of diabetic mothers (ODM). To address this gap, we devised the Study of Women, Infant Feeding and Type 2 Diabetes after GDM Pregnancy and Growth of their Offspring, also known as the SWIFT Offspring Study. This prospective, longitudinal study recruited mother-infant pairs from the SWIFT Study, a prospective study of women with recent gestational diabetes mellitus (GDM). The goal of the SWIFT Offspring Study is to determine whether breastfeeding intensity and duration, compared with formula feeding, are related to slower growth of GDM offspring during the first year life. This article details the study design, participant eligibility, data collection, and methodologies. We also describe the baseline characteristics of the GDM mother-infant pairs. The study enrolled 466 mother-infant pairs among GDM deliveries in northern California from 2009-2011. Participants attended three in-person study exams at 6-9 weeks, 6 months and 12 months after delivery for infant anthropometry (head circumference, body weight, length, abdominal circumference and skinfold thicknesses), as well as maternal anthropometry (body weight, waist circumference and percent body fat). Mothers also completed questionnaires on health and lifestyle behaviors, including infant diet, sleep and temperament. Breastfeeding intensity and duration were assessed via several sources (diaries, telephone interviews, monthly mailings and in-person exams) from birth through the first year of life. Pregnancy course, clinical perinatal and newborn outcomes were obtained from health plan electronic

  18. Impact of baseline patient characteristics on interventions to reduce diabetes distress: the role of personal conscientiousness and diabetes self-efficacy

    PubMed Central

    Fisher, L.; Hessler, D.; Masharani, U.; Strycker, L.

    2014-01-01

    Aims To improve patient-centred care by determining the impact of baseline levels of conscientiousness and diabetes self-efficacy on the outcomes of efficacious interventions to reduce diabetes distress and improve disease management. Methods Adults with Type 2 diabetes with diabetes distress and self-care problems (N=392) were randomized to one of three distress reduction interventions: computer-assisted self-management; computer-assisted self-management plus problem-solving therapy; and health education. The baseline assessment included conscientiousness and self-efficacy, demographics, diabetes status, regimen distress, emotional burden, medication adherence, diet and physical activity. Changes in regimen distress, emotional burden and self-care between baseline and 12 months were recorded and ANCOVA models assessed how conscientiousness and self-efficacy qualified the significant improvements in distress and management outcomes. Results Participants with high baseline conscientiousness displayed significantly larger reductions in medication adherence and emotional burden than participants with low baseline conscientiousness. Participants with high baseline self-efficacy showed greater improvements in diet, physical activity and regimen distress than participants with low baseline self-efficacy. The impact of conscientiousness and self-efficacy were independent of each other and occurred across all three intervention groups. A significant interaction indicated that those with both high self-efficacy and high conscientiousness at baseline had the biggest improvement in physical activity by 12 months. Conclusions Both broad personal traits and disease-specific expectations qualify the outcomes of efficacious interventions. These findings reinforce the need to change from a one-size-fits-all approach to diabetes interventions to an approach that crafts clinical interventions in ways that fit the personal traits and skills of individual people. (Clinical Trials

  19. Probiotic supplementation and the effects on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled trial.

    PubMed

    Ahmadi, Shahnaz; Jamilian, Mehri; Karamali, Maryam; Tajabadi-Ebrahimi, Maryam; Jafari, Parvaneh; Taghizadeh, Mohsen; Memarzadeh, Mohammad Reza; Asemi, Zatollah

    2017-02-01

    The aim of the current study was to assess the effects of probiotic supplementation on weight loss, glycaemia and lipid profiles in women with polycystic ovary syndrome (PCOS). In a randomized, double-blind, placebo-controlled trial, 60 women with PCOS were randomized to receive probiotic capsule (n = 30) or placebo (n = 30) for 12 weeks. Consumption of probiotic supplements resulted in a significant reduction in weight (-0.5 ± 0.4 vs. +0.1 ± 1.0 kg, p = 0.004) and BMI (-0.2 ± 0.2 vs. +0.03 ± 0.4 kg/m(2), p = 0.004) compared with the placebo. In addition, compared with the placebo, probiotic administration was associated with a significant decrease in fasting plasma glucose (-2.4 ± 8.4 vs. +2.1 ± 7.0 mg/dL, p = 0.02), serum insulin concentrations (-2.0 ± 5.8 vs. +1.6 ± 5.0 μIU/mL, p = 0.01), homoeostasis model of assessment-insulin resistance (-0.5 ± 1.4 vs. +0.3 ± 1.1, p = 0.01), homoeostatic model assessment-beta cell function (-7.5 ± 22.3 vs. +6.3 ± 21.7, p = 0.01), serum triglycerides (-13.3 ± 51.3 vs. +13.6 ± 37.1 mg/dL, p= 0.02) and a significant increase in quantitative insulin sensitivity check index (QUICKI) (+0.006 ± 0.01 vs. -0.005 ± 0.02, p = 0.01). When we adjusted the analysis for baseline values of biochemical parameters, age and baseline BMI, except for QUICKI (p = 0.08), other findings did not alter. We found that probiotic supplementation among PCOS women for 12 weeks had favourable effects on weight loss, markers of insulin resistance, triglycerides and VLDL-cholesterol concentrations.

  20. Baseline characteristics of the omega-3 fatty acids (Fish oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study.

    PubMed

    Viecelli, Andrea K; Pascoe, Elaine M; Polkinghorne, Kevan R; Hawley, Carmel M; Paul-Brent, Peta-Anne; Badve, Sunil V; Cass, Alan; Johnson, David W; Kerr, Peter G; Mori, Trevor A; Scaria, Anish; Hooi, Seong L; Ong, Meng L; Irish, Ashley B

    2016-03-01

    The Fish oils and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) trial investigated whether 3 months of omega-3 polyunsaturated fatty acids, either alone or in combination with aspirin, will effectively reduce primary access failure of de novo arteriovenous fistulae. This report presents the baseline characteristics of all study participants, examines whether study protocol amendments successfully increased recruitment of a broader and more representative haemodialysis cohort, including patients already receiving aspirin, and contrasts Malaysian participants with those from Australia, New Zealand and the United Kingdom (UK). This international, randomized, double-blind, placebo-controlled trial included patients older than 19 years with stage 4 or 5 chronic kidney disease currently receiving, or planned within 12 months to receive haemodialysis. Participants (n = 568) were overweight (28.6 ± 7.3 kg/m(2) ), relatively young (54.8 ± 14.3 years), and predominantly male (63%) with a high prevalence of diabetes mellitus (46%) but low rate of ischaemic heart disease (8%). Sixty one percent were planned for lower arm arteriovenous fistula creation. Malaysian participants (n = 156) were younger (51.8 ± 13.6 years vs 57.1 ± 14.2 years, P < 0.001) with a higher prevalence of diabetes mellitus (65% vs 43%, P < 0.001), but less ischaemic heart disease (5% vs 14%, P < 0.01) compared with the combined Australian, New Zealand and UK cohort (n = 228). Protocol modifications allowing for inclusion of patients receiving aspirin increased the prevalence of co-morbidities compared with the original cohort. The FAVOURED study participants, while mostly similar to patients in contemporary national registry reports and comparable recent clinical trials, were on average younger and had less ischaemic heart disease. These differences were reduced as a consequence of including patients already receiving aspirin. © 2015 Asian

  1. Design and baseline characteristics of the PerfectFit study: a multicenter cluster-randomized trial of a lifestyle intervention in employees with increased cardiovascular risk.

    PubMed

    Kouwenhoven-Pasmooij, Tessa A; Djikanovic, Bosiljka; Robroek, Suzan J W; Helmhout, Pieter; Burdorf, Alex; Hunink, M G Myriam

    2015-07-28

    The prevalence of unhealthy lifestyles and preventable chronic diseases is high. They lead to disabilities and sickness absence, which might be reduced if health promotion measures were applied. Therefore, we developed the PerfectFit health promotion intervention with a "blended care"-approach, which consists of a web-based health risk assessment (HRA) including tailored and personalized advice, followed by motivational interviewing (MI). We hypothesize that adding MI to a web-based HRA leads to better health outcomes. The objective is to describe the design and baseline characteristics of the PerfectFit study, which is being conducted among employees with high cardiovascular risk in the military workforce, the police organization and an academic hospital. PerfectFit is a cluster randomized controlled trial, consisting of two arms. Based on cardiovascular risk profiling, done between 2012 and 2014, we included employees based on one or more risk factors and motivation to participate. One arm is the 'limited' health program (control) that consists of: (a) an HRA as a decision aid for lifestyle changes, including tailored and personalized advice, and pros and cons of the options, and (b) a newsletter every 3 months. The other arm is the 'extensive' program (intervention), which is additionally offered MI-sessions by trained occupational physicians, 4 face-to-face and 3 by telephone, and is offered more choices of health promotion activities in the HRA. During the follow-up period, participants choose the health promotion activities they personally prefer. After six and twelve months, outcomes will be assessed by online questionnaires. After twelve months the cardiovascular risk profiling will be repeated. The primary outcome is self-reported general health. Secondary outcomes are self-reported work ability, CVD-risk score, sickness absence, productivity loss at work, participation in health promotion activities, changes in lifestyle (smoking, alcohol consumption

  2. Neuroendocrine disruption in the shore crab Carcinus maenas: Effects of serotonin and fluoxetine on chh- and mih-gene expression, glycaemia and ecdysteroid levels.

    PubMed

    Robert, Alexandrine; Monsinjon, Tiphaine; Delbecque, Jean-Paul; Olivier, Stéphanie; Poret, Agnès; Foll, Frank Le; Durand, Fabrice; Knigge, Thomas

    2016-06-01

    Serotonin, a highly conserved neurotransmitter, controls many biological functions in vertebrates, but also in invertebrates. Selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, are commonly used in human medication to ease depression by affecting serotonin levels. Their residues and metabolites can be detected in the aquatic environment and its biota. They may also alter serotonin levels in aquatic invertebrates, thereby perturbing physiological functions. To investigate whether such perturbations can indeed be expected, shore crabs (Carcinus maenas) were injected either with serotonin, fluoxetine or a combination of both. Dose-dependent effects of fluoxetine ranging from 250 to 750nM were investigated. Gene expression of crustacean hyperglycemic hormone (chh) as well as moult inhibiting hormone (mih) was assessed by RT-qPCR at 2h and 12h after injection. Glucose and ecdysteroid levels in the haemolymph were monitored in regular intervals until 12h. Serotonin led to a rapid increase of chh and mih expression. On the contrary, fluoxetine only affected chh and mih expression after several hours, but kept expression levels significantly elevated. Correspondingly, serotonin rapidly increased glycaemia, which returned to normal or below normal levels after 12h. Fluoxetine, however, resulted in a persistent low-level increase of glycaemia, notably during the period when negative feedback regulation reduced glycaemia in the serotonin treated animals. Ecdysteroid levels were significantly decreased by serotonin and fluoxetine, with the latter showing less pronounced and less rapid, but longer lasting effects. Impacts of fluoxetine on glycaemia and ecdysteroids were mostly observed at higher doses (500 and 750nM) and affected principally the response dynamics, but not the amplitude of glycaemia and ecdysteroid-levels. These results suggest that psychoactive drugs are able to disrupt neuroendocrine control in decapod crustaceans, as they interfere with the

  3. Characteristics of the National Institute of Health Stroke Scale: results from a population-based stroke cohort at baseline and after one year.

    PubMed

    Appelros, Peter; Terént, Andreas

    2004-01-01

    The National Institute of Health Stroke Scale (NIHSS) results at baseline and after 1 year have never before been accounted for within an unselected population-based stroke sample. Neither has it been shown which individual items in the scale are the most important ones for the outcome in terms of death or dependency after 1 year. The subjects were all patients within a municipality who had their first-ever non-subarachnoidal stroke during 1 year (n = 377). Impairment was evaluated at baseline (within 24-48 h) and after 1 year with the 15-item version of the NIHSS. At the 1-year follow-up, the Modified Rankin Scale was used in order to determine which patients were dependent. Predictors of death and dependency were analysed in logistic regression models. The different NIHSS items, age and gender were used as independent variables. The median NIHSS score was 6 (interquartile range 3-12) at baseline and 1 (interquartile range 0-3) at the 1-year follow-up, when 33% of the patients had died. Of patients scoring less than 4 on baseline NIHSS, 75% were functionally independent after 1 year. Seventeen per cent were functionally dependent and 8% were dead. Independent predictors of death were: age, questions, commands, gaze, alertness and sensation. Independent predictors of dependency were: age, commands, alertness and motor leg. Baseline NIHSS predicts the outcome after 1 year at the group level. Age and any reduction of the level of consciousness on arrival were associated with bad outcome after 1 year. Copyright 2004 S. Karger AG, Basel

  4. Influence of feeding a fish oil-containing diet to mature, overweight dogs: Effects on lipid metabolites, postprandial glycaemia and body weight.

    PubMed

    de Godoy, M R C; McLeod, K R; Harmon, D L

    2017-05-15

    The objective of this study was to determine the effect of feeding a fish oil (FO)-containing diet on lipid and protein metabolism, postprandial glycaemia and body weight (BW) of mature, overweight dogs. Seven female dogs were randomly assigned to one of two isonitrogenous and isocaloric diets, control (CO) or FO (FO), in a crossover design. Experimental periods were 69 day, separated by a washout period of 30 day. At the beginning of the experiment, and at 30 and 60 day of feeding the experimental diets, the dogs were infused with D-glucose (2 g/kg BW) through an intravenous catheter. Blood samples were collected for 3 hr to perform a glucose tolerance test. Nitrogen balance measurements began at 06:30 on d 63 of each experimental period and ended at 06:30 on d 69. On d 66 of each period, a single dose (7.5 mg/kg) of (15) N-glycine was administered orally for determination of protein turnover. Incremental area under the curve and glucose concentration at peak did not differ between treatments or among sampling days within treatment. Glucose half-life tended to decrease (p < .10) in the FO treatment on day 30 when compared to baseline (day 0). β-hydroxybutyrate, non-esterified fatty acid (NEFA) and triglycerides did not differ within or between treatments. Cholesterol decreased (p < .05) on the FO treatment on day 30, 60 and 69 when compared to day 0. High-density lipoprotein (HDL) decreased (p < .05) in the FO treatment on day 69 when compared to day 0. Body weight, food intake, faecal excretion, DM and N digestibilities, N balance and protein turnover were not different between diets. Overall, FO-containing diet decreases cholesterol in mature overweight dogs; however, further research is warranted to verify the effects of FO on glucose metabolism. © 2017 Blackwell Verlag GmbH.

  5. Disseminating a smoking cessation intervention to childhood and young adult cancer survivors: baseline characteristics and study design of the partnership for health-2 study.

    PubMed

    de Moor, Janet S; Puleo, Elaine; Ford, Jennifer S; Greenberg, Mark; Hodgson, David C; Tyc, Vida L; Ostroff, Jamie; Diller, Lisa R; Levy, Andrea Gurmankin; Sprunck-Harrild, Kim; Emmons, Karen M

    2011-05-11

    Partnership for Health-2 (PFH-2) is a web-based version of Partnership for Health, an evidence-based smoking cessation intervention for childhood cancer survivors. This paper describes the PFH-2 intervention and baseline data collection. 374 childhood and young adult cancer survivors were recruited from five cancer centers and participated in the baseline assessment. At baseline, participants completed measures of their smoking behavior, self-efficacy and stage of change for quitting smoking as well as psychological and environmental factors that could impact their smoking behavior. At baseline, 93% of survivors smoked in the past seven days; however, 89% smoked a pack or less during this period. Forty-seven percent were nicotine dependent, and 55% had made at least one quit attempt in the previous year. Twenty-two percent of survivors were in contemplation for quitting smoking; of those 45% were somewhat or very confident that they could quit within six months. Sixty-three percent were in preparation for quitting smoking; however, they had relatively low levels of confidence that they could quit smoking in the next month. In multivariate analyses, stage of change, self-efficacy, social support for smoking cessation, smoking policy at work and home, fear of cancer recurrence, perceived vulnerability, depression, BMI, and contact with the healthcare system were associated with survivors' smoking behavior. A large proportion of the sample was nicotine dependent, yet motivated to quit. Individual- interpersonal- and environmental-level factors were associated with survivors' smoking behavior. Smoking is particularly dangerous for childhood and young adult cancer survivors. This population may benefit from a smoking cessation intervention designed to build self-efficacy and address other known predictors of smoking behavior.

  6. Design and baseline characteristics of participants in the study of antihypertensive therapy in children and adolescents with autosomal dominant polycystic kidney disease (ADPKD).

    PubMed

    Cadnapaphornchai, Melissa A; Fick-Brosnahan, Godela M; Duley, Irene; Johnson, Ann M; Strain, John D; DeGroff, Curt G; Schrier, Robert W

    2005-04-01

    In this manuscript, we describe our ongoing randomized clinical trial to assess the efficacy of blood pressure control with angiotensin converting enzyme (ACE) inhibition on renal cyst growth over a 5-year study period in children and young adults aged 4-21 years with autosomal dominant polycystic kidney disease (ADPKD). Baseline demographic and laboratory data for the study groups are reported. Results of this study could significantly impact the standard of care for management of ADPKD in this population.

  7. Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson's Disease.

    PubMed

    Seiple, William; Jennings, Danna; Rosen, Richard B; Borchert, Leona; Canale, Lee; Fagan, Nora; Gordon, Mark Forrest

    2016-01-01

    Background. Parkinson's disease (PD) progressively affects dopaminergic neurotransmission and may affect retinal dopaminergic functions and structures. Objective. This 2-year randomized, open-label, parallel-group, flexible-dose study, NCT00144300, evaluated ophthalmologic safety profiles of immediate-release (IR) pramipexole and ropinirole in patients with early idiopathic PD with ≤6 months' prior dopamine agonist exposure and without preexisting major eye disorders. Methods. Patients received labeled IR regimens of pramipexole (n = 121) or ropinirole (n = 125) for 2 years. Comprehensive ophthalmologic assessments (COA) included corrected acuity, Roth 28-color test, slit-lamp biomicroscopy, intraocular pressure, computerized visual field test, fundus photography, and electroretinography. Results. At baseline, we observed retinal pigmentary epithelium (RPE) hypopigmentation not previously reported in PD patients. The estimated relative risk of 2-year COA worsening with pramipexole versus ropinirole was 1.07 (95% CI: 0.71-1.60). Mean changes from baseline in Unified Parkinson's Disease Rating System parts II+III total scores (pramipexole: 1 year, -4.1 ± 8.9, and 2 years, -0.7 ± 10.1, and ropinirole: 1 year, -3.7 ± 8.2, and 2 years, -1.7 ± 10.5) and Hoehn-Yahr stage distribution showed therapeutic effects on PD symptoms. Safety profiles were consistent with labeling. Conclusions. The risk of retinal deterioration did not differ in early idiopathic PD patients receiving pramipexole versus ropinirole. RPE hypopigmentation at baseline was not previously reported in this population. This trial is registered with NCT00144300.

  8. Observational Registry of Basal Insulin Treatment (ORBIT) in Patients with Type 2 Diabetes Uncontrolled by Oral Hypoglycemic Agents in China--Study Design and Baseline Characteristics.

    PubMed

    Ji, Linong; Zhang, Puhong; Weng, Jianping; Lu, Juming; Guo, Xiaohui; Jia, Weiping; Yang, Wenying; Zou, Dajin; Zhou, Zhiguang; Pan, Changyu; Gao, Yan; Li, Xian; Zhu, Dongshan; Li, Ying; Wu, Yangfeng; Garg, Satish K

    2015-10-01

    Efficacy of basal insulin (BI) has been well studied by randomized controlled trials, but the impact of BI on glycemic control in the real world has not been well documented. The Observational Registry for BI Treatment (ORBIT) study is designed to evaluate the real-life outcomes of BI in China. Participants with type 2 diabetes (n=19,894), from December 2011 to June 2013, inadequately controlled on oral hypoglycemic agents (OHAs) were initiated on BI treatment from 209 hospitals in all the eight regions in Mainland China. Data for each patient on use of OHAs and insulin (type and dose), glycemic control, hypoglycemic episodes, body weight, quality of life, and costs were collected at baseline and 3 and 6 months. For the 18,995 participants who were eligible for baseline analysis, mean±SD age was 55.4±10.4 years, with 52.5% males. The mean duration of diabetes was 6.4±5.3 years and was positively associated with the economic level of eight regions. Before initiation of BI, patients had a mean hemoglobin A1c level of 9.6±2.0% with a fasting plasma glucose level of 11.7±4.0 mmol/L. Of the patients, 35.5% had some diabetes complications. Metformin, sulfonylureas, and α-glycosidase inhibitors were the most commonly used OHAs. The proportions of patients using one, two, or more than two OHAs before BI initiation were 48.4%, 42.7%, and 8.9%, respectively. To the best of our knowledge, the ORBIT study is the largest registry study to evaluate glycemic outcomes and safety of BI in real-world China. Baseline data indicate delays in initiation of BI in the majority of patients with type 2 diabetes in China.

  9. Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson's Disease

    PubMed Central

    Jennings, Danna; Borchert, Leona; Canale, Lee; Fagan, Nora

    2016-01-01

    Background. Parkinson's disease (PD) progressively affects dopaminergic neurotransmission and may affect retinal dopaminergic functions and structures. Objective. This 2-year randomized, open-label, parallel-group, flexible-dose study, NCT00144300, evaluated ophthalmologic safety profiles of immediate-release (IR) pramipexole and ropinirole in patients with early idiopathic PD with ≤6 months' prior dopamine agonist exposure and without preexisting major eye disorders. Methods. Patients received labeled IR regimens of pramipexole (n = 121) or ropinirole (n = 125) for 2 years. Comprehensive ophthalmologic assessments (COA) included corrected acuity, Roth 28-color test, slit-lamp biomicroscopy, intraocular pressure, computerized visual field test, fundus photography, and electroretinography. Results. At baseline, we observed retinal pigmentary epithelium (RPE) hypopigmentation not previously reported in PD patients. The estimated relative risk of 2-year COA worsening with pramipexole versus ropinirole was 1.07 (95% CI: 0.71–1.60). Mean changes from baseline in Unified Parkinson's Disease Rating System parts II+III total scores (pramipexole: 1 year, −4.1 ± 8.9, and 2 years, −0.7 ± 10.1, and ropinirole: 1 year, −3.7 ± 8.2, and 2 years, −1.7 ± 10.5) and Hoehn–Yahr stage distribution showed therapeutic effects on PD symptoms. Safety profiles were consistent with labeling. Conclusions. The risk of retinal deterioration did not differ in early idiopathic PD patients receiving pramipexole versus ropinirole. RPE hypopigmentation at baseline was not previously reported in this population. This trial is registered with NCT00144300. PMID:28078162

  10. Metabolic management in overweight subjects with naive impaired fasting glycaemia by means of a highly standardized extract from Cynara scolymus: a double-blind, placebo-controlled, randomized clinical trial.

    PubMed

    Rondanelli, Mariangela; Opizzi, Annalisa; Faliva, Milena; Sala, Patrizio; Perna, Simone; Riva, Antonella; Morazzoni, Paolo; Bombardelli, Ezio; Giacosa, Attilio

    2014-01-01

    The aim of this study is to evaluate the efficacy of a dietary supplementation with an extract from Cynara scolymus (Cs) on the glucose pattern in a group of patients with naïve impaired fasting glycaemia (IFG). A randomized, double-blind, placebo-controlled trial has been performed in 55 overweight subjects with IFG (fasting blood glucose [FBG]: 6.11 ± 0.56 mmol/l). These subjects were randomly assigned to supplement their diet with either an extract from Cs (600 mg/d) (26 subjects) or placebo (29 matched subjects) for 8 weeks. The decrease of FBG was the primary endpoint. The assessment of Homeostatic Metabolic Assessment (HOMA), glycosylated haemoglobin, A1c-Derived Average Glucose (ADAG), lipidic pattern and anthropometric parameters were the secondary endpoints. The within groups and percent changes from baseline were analyzed by the signed rank test. The comparison between groups was performed by Wilcoxon's two sample test. The supplemented group had significant decreases of: FBG (-9.6%), HOMA (-11.7%), glycosylated haemoglobin (-2.3%), ADAG (-3.1%) and lipidic pattern. The placebo group did not show any significant difference. Compared with the placebo, the supplemented group showed a significant difference in FBG, HOMA and lipidic pattern. These data demonstrate the efficacy of Cs extract on the reduction of glycometabolic parameters in overweight subjects with IFG.

  11. The BEAUTIFUL study: randomized trial of ivabradine in patients with stable coronary artery disease and left ventricular systolic dysfunction - baseline characteristics of the study population.

    PubMed

    Ferrari, R; Ford, I; Fox, K; Steg, P G; Tendera, M

    2008-01-01

    Ivabradine is a selective heart rate-lowering agent that acts by inhibiting the pacemaker current If in sinoatrial node cells. Patients with coronary artery disease and left ventricular dysfunction are at high risk of death and cardiac events, and the BEAUTIFUL study was designed to evaluate the effects of ivabradine on outcome in such patients receiving optimal medical therapy. This report describes the study population at baseline. BEAUTIFUL is an international, multicentre, randomized, double-blind trial to compare ivabradine with placebo in reducing mortality and cardiovascular events in patients with stable coronary artery disease and left ventricular systolic dysfunction (ejection fraction <40%). A total of 10,917 patients were randomized. At baseline, their mean age was 65 years, 83% were male, 98% Caucasian, 88% had previous myocardial infarction, 37% had diabetes, and 40% had metabolic syndrome. Mean ejection fraction was 32% and resting heart rate was 71.6 bpm. Concomitant medications included beta-blockers (87%), renin-angiotensin system agents (89%), antithrombotic agents (94%), and lipid-lowering agents (76%). Main results from BEAUTIFUL are expected in 2008, and should show whether ivabradine, on top of optimal medical treatment, reduces mortality and cardiovascular events in this population of high-risk patients. (c) 2007 S. Karger AG, Basel

  12. Baseline characteristics and hospitalizations in patients with schizophrenia receiving olanzapine long-acting injection: an interim analysis from a non-interventional, prospective observational safety study.

    PubMed

    Jones, Meghan E; Andrews, Jeffrey S; Faries, Douglas E; Landry, John; Xu, Jenny; Detke, Holland C; Chhabra-Khanna, Rashna; McDonnell, David P

    2015-11-13

    Depot antipsychotics are a treatment option for medication nonadherence in patients with schizophrenia. Nonadherence can lead to increased relapse and hospitalization rates. This article reports hospitalization data before and after initiation of olanzapine long-acting injection (LAI), a depot antipsychotic. Data were assessed from an ongoing, multinational, prospective, observational post-authorisation safety study being conducted to evaluate post-injection delirium/sedation syndrome (PDSS), an adverse reaction that can occur following injection of olanzapine LAI. Eligible patients were aged ≥18 years, diagnosed with schizophrenia, were prescribed olanzapine LAI, and lived outside the United States. Psychiatric hospitalization and medication data were collected retrospectively for the 6-month period before study entry and prospectively throughout the study. Paired t-tests and McNemar's tests were used to assess changes in hospitalization incidence and duration. Stepwise Cox proportional hazards models assessed factors associated with hospitalizations. Analyses were based on data from the first 3 years of the continuously enrolling study (N = 668). The average duration of olanzapine LAI exposure for all patients was 0.768 years. Of the 529 patients who received at least 1 injection of olanzapine LAI and were not hospitalized at study entry, 8.1% had at least 1 subsequent psychiatric hospitalization with a mean duration of 2.0 days. Of the 288 patients who had a >6-month follow-up, 8.3% had at least 1 post-baseline psychiatric hospitalization with a mean duration of 2.3 days. The incidence of hospitalizations in the 6-month period after treatment was significantly lower than that in the 6-month period prior to treatment (8.3 vs 32.6%, respectively; P < 0.001). Furthermore, mean hospitalization duration decreased from 11.5 days in the 6-month period before treatment to 2.3 days in the 6-month period after treatment (P < 0.001). Psychiatric

  13. Urinary Obstruction in Prostate Cancer Patients From the Dutch Trial (68 Gy vs. 78 Gy): Relationships With Local Dose, Acute Effects, and Baseline Characteristics

    SciTech Connect

    Heemsbergen, Wilma D.; Al-Mamgani, Abrahim; Witte, Marnix G.; Herk, Marcel van; Pos, Floris J.; Lebesque, Joos V.

    2010-09-01

    Purpose: To investigate the relationship between late urinary obstruction and the details of the dose distribution of irradiated prostate cancer patients, taking into account their baseline symptoms and acute complaints. Patients and Methods: We selected patients from the Dutch multicenter trial randomized between 68 Gy and 78 Gy, for whom toxicity data and dose data were available (n = 557). The absolute dose surface parameters of the delineated bladder were calculated. Next, we constructed three-dimensional dose maps of the area around the prostate, providing an approximate identification of the corresponding anatomic locations. The dose difference maps were constructed by subtracting the mean dose maps of the patients with and without late urinary obstruction. Selected local dose points were analyzed using Cox regression analysis. Results: Urinary obstruction was scored for 40 patients, including 19 of 296 patients who received 68-72 Gy and 21 of 261 patients who received 76-78 Gy. A total of 19 events occurred within 2 years after irradiation and 21 events after 2 years. The bladder surface receiving {>=}80 Gy predicted (p <.01) the occurrence of obstruction within 2 years. The dose difference map indicated highly significant differences in the bladder neck situated in the trigonal region (p < .001) that were especially predictive of obstruction after 2 years and of the diagnosis of bladder neck obstruction. Baseline complaints and transurethral resection of the prostate and acute complaints were mainly predictive for obstruction within 2 years. Conclusion: Relatively early events of urinary obstruction were associated with urinary problems existing before RT, acute toxicity, previous transurethral resection of the prostate, and hotspots in the bladder. Events after 2 years were associated with the local dose in the trigonal area.

  14. Methods and baseline characteristics of a randomized trial treating early childhood obesity: The Positive Lifestyles for Active Youngsters (Team PLAY) trial

    PubMed Central

    Hare, Marion; Coday, Mace; Williams, Natalie A.; Richey, Phyllis; Tylavsky, Frances; Bush, Andrew

    2012-01-01

    There are few effective obesity interventions directed towards younger children, particularly young minority children. This paper describes the design, intervention, recruitment methods, and baseline data of the ongoing Positive Lifestyles for Active Youngsters (Team PLAY) study. This randomized controlled trial is designed to test the efficacy of a 6-month, moderately intense, primary care feasible, family-based behavioral intervention, targeting both young children and their parent, in promoting healthy weight change. Participants are 270 overweight and obese children (ages 4 to 7 years) and their parent, who were recruited from a primarily African American urban population. Parents and children were instructed in proven cognitive behavioral techniques (e.g. goal setting, self-talk, stimulus control and reinforcement) designed to encourage healthier food choices (more whole grains, fruits and vegetables, and less concentrated fats and sugar), reduce portion sizes, decrease sweetened beverages and increase moderate to vigorous physical activity engagement. The main outcome of this study is change in BMI at two years post enrollment. Recruitment using reactive methods (mailings, TV ads, pamphlets) was found to be more successful than using only a proactive approach (referral through physicians). At baseline, most children were very obese with an average BMI z-score of 2.6. Reported intake of fruits and vegetables and minutes of moderate to vigorous physical activity engagement did not meet national recommendations. If efficacious, Team PLAY would offer a model for obesity treatment directed at families with young children that could be tested and translated to both community and primary care settings. PMID:22342450

  15. Baseline General Characteristics of the Korean Chronic Kidney Disease: Report from the KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD).

    PubMed

    Kang, Eunjeong; Han, Miyeun; Kim, Hyunsuk; Park, Sue Kyung; Lee, Joongyub; Hyun, Young Youl; Kim, Yong Soo; Chung, Wookyung; Kim, Hyo Jin; Oh, Yun Kyu; Ahn, Curie; Oh, Kook Hwan

    2017-02-01

    The KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD) was developed to investigate various clinical courses and risk factors for progression of Korean chronic kidney disease (CKD). The KNOW-CKD study consists of nine clinical centers in Korea, and patients aged between 20 and 75 years with CKD from stage 1 to 5 (predialysis) were recruited. At baseline, blood and urine samples were obtained and demographic data including comorbidities, drugs, quality of life, and health behaviors were collected. Estimated glomerular filtration rate (eGFR) was calculated by 4-variable Modification of Diet in Renal Disease (MDRD) equation using isotope dilution mass spectrometry (IDMS)-calibrated serum creatinine measured at a central laboratory. As a dynamic cohort, a total of 2,341 patients were enrolled during the enrollment period from 2011 until 2015, among whom 2,238 subjects were finally analyzed for baseline profiles. The mean age of the cohort was 53.7 ± 12.2 year and 61.2% were men. Mean eGFR was 50.5 ± 30.3 mL/min/1.73 m². The participants with lower eGFR had a tendency to be older, with more comorbidities, to have higher systolic blood pressure (BP) and pulse pressure, with lower income level and education attainment. The patients categorized as glomerulonephritis (GN) were 36.2% followed by diabetic nephropathy (DN, 23.2%), hypertensive nephropathy (HTN, 18.3%), polycystic kidney disease (PKD, 16.3%), and other unclassified disease (6.1%). The KNOW-CKD participants will be longitudinally followed for 10 years. The study will provide better understanding for physicians regarding clinical outcomes, especially renal and cardiovascular outcomes in CKD patients.

  16. Baseline General Characteristics of the Korean Chronic Kidney Disease: Report from the KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD)

    PubMed Central

    2017-01-01

    The KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD) was developed to investigate various clinical courses and risk factors for progression of Korean chronic kidney disease (CKD). The KNOW-CKD study consists of nine clinical centers in Korea, and patients aged between 20 and 75 years with CKD from stage 1 to 5 (predialysis) were recruited. At baseline, blood and urine samples were obtained and demographic data including comorbidities, drugs, quality of life, and health behaviors were collected. Estimated glomerular filtration rate (eGFR) was calculated by 4-variable Modification of Diet in Renal Disease (MDRD) equation using isotope dilution mass spectrometry (IDMS)-calibrated serum creatinine measured at a central laboratory. As a dynamic cohort, a total of 2,341 patients were enrolled during the enrollment period from 2011 until 2015, among whom 2,238 subjects were finally analyzed for baseline profiles. The mean age of the cohort was 53.7 ± 12.2 year and 61.2% were men. Mean eGFR was 50.5 ± 30.3 mL/min/1.73 m2. The participants with lower eGFR had a tendency to be older, with more comorbidities, to have higher systolic blood pressure (BP) and pulse pressure, with lower income level and education attainment. The patients categorized as glomerulonephritis (GN) were 36.2% followed by diabetic nephropathy (DN, 23.2%), hypertensive nephropathy (HTN, 18.3%), polycystic kidney disease (PKD, 16.3%), and other unclassified disease (6.1%). The KNOW-CKD participants will be longitudinally followed for 10 years. The study will provide better understanding for physicians regarding clinical outcomes, especially renal and cardiovascular outcomes in CKD patients. PMID:28049232

  17. Photoaging smartphone app promoting poster campaign to reduce smoking prevalence in secondary schools: the Smokerface Randomized Trial: design and baseline characteristics

    PubMed Central

    Holzapfel, Julia; Baudson, Tanja G; Sies, Katharina; Jakob, Lena; Baumert, Hannah Maria; Heckl, Marlene; Cirac, Ana; Suhre, Janina L; Mathes, Verena; Spielmann, Hannah; Rigotti, Nancy; Herth, Felix; Groneberg, David A; Raupach, Tobias; Gall, Henning; Bauer, Claudia; Marek, Pat; Batra, Anil; Harrison, Chase H; Taha, Lava; Owczarek, Andreas; Hofmann, Felix J; Thomas, Roger; Mons, Ute; Kreuter, Michael

    2016-01-01

    Introduction Smoking is the largest cause of preventable death globally. Most smokers smoke their first cigarette in early adolescence. We took advantage of the widespread availability of mobile phones and adolescents’ interest in appearance to develop a free photoaging app which is promoted via a poster campaign in secondary schools. This study aims to evaluate its effectiveness regarding smoking prevalence and students’ attitudes towards smoking. Methods and analysis A randomised controlled trial is conducted with 9851 students of both genders with an average age of 12 years in grades 6 and 7 of 126 secondary schools in Germany. At present, cigarette smoking prevalence in our sample is 4.7%, with 4.6% of the students currently using e-cigarettes (1.6% use both). The prospective experimental study design includes measurements at baseline and at 6, 12 and 24 months postintervention via a questionnaire plus a random cotinine saliva sample at 24 months postintervention. The study groups consist of randomised schools receiving the Smokerface poster campaign and control schools with comparable baseline data (no intervention). The primary end point is the difference of change in smoking prevalence in the intervention group versus the difference in the control group at 24 months follow-up. Longitudinal changes in smoking-related attitudes, the number of new smokers and quitters and the change in the number of never-smokers will be compared between the two groups as secondary outcomes. Ethics and dissemination Ethical approval was obtained from the ethics committee of the University of Gießen and the ministries of cultural affairs, both in Germany. Results will be disseminated at conferences, in peer-reviewed journals, on our websites and throughout the multinational Education Against Tobacco network. Trial registration number NCT02544360, Pre-results. PMID:27821601

  18. Design and baseline characteristics of participants in the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial on the cardiovascular effects of dulaglutide.

    PubMed

    Gerstein, Hertzel C; Colhoun, Helen M; Dagenais, Gilles R; Diaz, Rafael; Lakshmanan, Mark; Pais, Prem; Probstfield, Jeffrey; Riddle, Matthew C; Rydén, Lars; Xavier, Denis; Atisso, Charles M; Avezum, Alvaro; Basile, Jan; Chung, Namsik; Conget, Ignacio; Cushman, William C; Franek, Edward; Hancu, Nicolae; Hanefeld, Markolf; Holt, Shaun; Jansky, Petr; Keltai, Matyas; Lanas, Fernando; Leiter, Lawrence A; Lopez-Jaramillo, Patricio; Cardona-Munoz, Ernesto G; Pirags, Valdis; Pogosova, Nana; Raubenheimer, Peter J; Shaw, Jonathan; Sheu, Wayne H-H; Temelkova-Kurktschiev, Theodora

    2017-06-01

    The aim was to determine the effects of dulaglutide, a synthetic once-weekly, injectable human glucagon-like peptide 1 analogue that lowers blood glucose, body weight, appetite and blood pressure, on cardiovascular outcomes. People with type 2 diabetes, aged ≥50 years, with glycated haemoglobin (HbA1c) ≤9.5%, and either a previous cardiovascular event, evidence of cardiovascular disease or ≥2 cardiovascular risk factors were randomly allocated to a weekly subcutaneous injection of either dulaglutide (1.5 mg) or placebo and followed within the ongoing Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial every 3 to 6 months. The primary cardiovascular outcome is the first occurrence of the composite of cardiovascular death or non-fatal myocardial infarction or non-fatal stroke. Secondary outcomes include each component of the primary composite cardiovascular outcome, a composite clinical microvascular outcome comprising retinal or renal disease, hospitalization for unstable angina, heart failure requiring hospitalization or an urgent heart failure visit, and all-cause mortality. Follow-up will continue until the accrual of 1200 confirmed primary outcomes. Recruitment of 9901 participants (mean age 66 years, 46% women) occurred in 370 sites located in 24 countries over a period of 2 years. The mean duration of diabetes was 10 years, mean baseline HbA1c was 7.3%, and 31% had prior cardiovascular disease. The REWIND trial's international scope, high proportion of women, high proportion of people without prior cardiovascular disease and inclusion of participants whose mean baseline HbA1c was 7.3% suggests that its cardiovascular and safety findings will be directly relevant to the typical middle-aged patient seen in general practice throughout the world. © 2017 John Wiley & Sons Ltd.

  19. The Rationale, Design, and Baseline Characteristics of PREVENT-DM: A Community-Based Comparative Effectiveness Trial of Lifestyle Intervention and Metformin among Latinas with Prediabetes

    PubMed Central

    Perez, Alberly; Alos, Victor A.; Scanlan, Adam; Maia, Catarina M.; Davey, Adam; Whitaker, Robert C.; Foster, Gary D.; Ackermann, Ronald T.; O’Brien, Matthew J.

    2015-01-01

    Promotora Effectiveness Versus Metformin Trial (PREVENT-DM) is a randomized comparative effectiveness trial of a lifestyle intervention based on the Diabetes Prevention Program delivered by community health workers (or promotoras), metformin, and standard care. Eligibility criteria are Hispanic ethnicity, female sex, age ≥20 years, fluent Spanish-speaking status, BMI ≥23kg/m2, and prediabetes. We enrolled 92 participants and randomized them to one of the following three groups: standard care, DPP-based lifestyle intervention, or metformin. The primary outcome of the trial is the 12-month difference in weight between groups. Secondary outcomes include the following cardiometabolic markers: BMI, waist circumference, blood pressure, and fasting plasma glucose, hemoglobin A1C (HbA1c), total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and insulin. PREVENT-DM participants are socioeconomically disadvantaged Latinas with a mean annual household income of $15,527 ± 9,922 and educational attainment of 9.7 ± 3.6 years. Eighty-six percent of participants are foreign born, 20% have a prior history of gestational diabetes, and 71% have a first-degree relative with diagnosed diabetes. At baseline, PREVENT-DM participants had a mean age of 45.1 ± 12.5 years, weight of 178.8 ± 39.3lbs, BMI of 33.3 ± 6.5kg/m2, HbA1c of 5.9 ± 0.2%, and waist circumference of 97.4 ± 11.1cm. Mean baseline levels of other cardiometabolic markers were normal. The PREVENT-DM study successfully recruited and randomized an understudied population of Latinas with prediabetes. This trial will be the first U.S. study to test the comparative effectiveness of metformin and lifestyle intervention versus standard care among prediabetic adults in a “real-world” setting. PMID:26597415

  20. The rationale, design, and baseline characteristics of PREVENT-DM: A community-based comparative effectiveness trial of lifestyle intervention and metformin among Latinas with prediabetes.

    PubMed

    Perez, Alberly; Alos, Victor A; Scanlan, Adam; Maia, Catarina M; Davey, Adam; Whitaker, Robert C; Foster, Gary D; Ackermann, Ronald T; O'Brien, Matthew J

    2015-11-01

    Promotora Effectiveness Versus Metformin Trial (PREVENT-DM) is a randomized comparative effectiveness trial of a lifestyle intervention based on the Diabetes Prevention Program delivered by community health workers (or promotoras), metformin, and standard care. Eligibility criteria are Hispanic ethnicity, female sex, age ≥ 20 years, fluent Spanish-speaking status, BMI ≥ 23 kg/m(2), and prediabetes. We enrolled 92 participants and randomized them to one of the following three groups: standard care, DPP-based lifestyle intervention, or metformin. The primary outcome of the trial is the 12-month difference in weight between groups. Secondary outcomes include the following cardiometabolic markers: BMI, waist circumference, blood pressure, and fasting plasma glucose, hemoglobin A1C (HbA1c), total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and insulin. PREVENT-DM participants are socioeconomically disadvantaged Latinas with a mean annual household income of $15,527 ± 9922 and educational attainment of 9.7 ± 3.6 years. Eighty-six percent of participants are foreign born, 20% have a prior history of gestational diabetes, and 71% have a first-degree relative with diagnosed diabetes. At baseline, PREVENT-DM participants had a mean age of 45.1 ± 12.5 years, weight of 178.8 ± 39.3 lbs, BMI of 33.3 ± 6.5 kg/m(2), HbA1c of 5.9 ± 0.2%, and waist circumference of 97.4 ± 11.1cm. Mean baseline levels of other cardiometabolic markers were normal. The PREVENT-DM study successfully recruited and randomized an understudied population of Latinas with prediabetes. This trial will be the first U.S. study to test the comparative effectiveness of metformin and lifestyle intervention versus standard care among prediabetic adults in a "real-world" setting.

  1. Methods and baseline characteristics of a randomized trial treating early childhood obesity: the Positive Lifestyles for Active Youngsters (Team PLAY) trial.

    PubMed

    Hare, Marion E; Coday, Mace; Williams, Natalie A; Richey, Phyllis A; Tylavsky, Frances A; Bush, Andrew J

    2012-05-01

    There are few effective obesity interventions directed towards younger children, particularly young minority children. This paper describes the design, intervention, recruitment methods, and baseline data of the ongoing Positive Lifestyles for Active Youngsters (Team PLAY) study. This randomized controlled trial is designed to test the efficacy of a 6-month, moderately intense, primary care feasible, family-based behavioral intervention, targeting both young children and their parent, in promoting healthy weight change. Participants are 270 overweight and obese children (ages 4 to 7 years) and their parents, who were recruited from a primarily African American urban population. Parents and children were instructed in proven cognitive behavioral techniques (e.g. goal setting, self-talk, stimulus control and reinforcement) designed to encourage healthier food choices (more whole grains, fruits and vegetables, and less concentrated fats and sugar), reduce portion sizes, decrease sweetened beverages and increase moderate to vigorous physical activity engagement. The main outcome of this study is change in BMI at two year post enrollment. Recruitment using reactive methods (mailings, TV ads, pamphlets) was found to be more successful than using only a proactive approach (referral through physicians). At baseline, most children were very obese with an average BMI z-score of 2.6. Reported intake of fruits and vegetables and minutes of moderate to vigorous physical activity engagement did not meet national recommendations. If efficacious, Team PLAY would offer a model for obesity treatment directed at families with young children that could be tested and translated to both community and primary care settings.

  2. Effect of the extracts and fractions of Baccharis trimera and Syzygium cumini on glycaemia of diabetic and non-diabetic mice.

    PubMed

    Oliveira, Antônio Carlos P; Endringer, Denise C; Amorim, Luiz Alberto S; das Graças L Brandão, Maria; Coelho, Márcio M

    2005-12-01

    In the present study, we investigated the effects of extracts and fractions of Baccharis trimera and Syzygium cumini on glycaemia of diabetic and non-diabetic mice. Crude ethanolic extracts and aqueous and butanolic fractions of the aerial parts of Baccharis trimera and leaves of Syzygium cumini were evaluated. None of the extracts or fractions (200 or 2000 mg/kg, per os) induced any effect after acute administration. Seven-day treatment with crude ethanolic and aqueous and butanolic fractions (200-2000 mg/kg, twice daily, per os) of Syzygium cumini reduced glycaemia of non-diabetic mice. However, this effect was associated with a reduction of food intake and body weight, indicating that this may not be a genuine hypoglycaemic effect. In diabetic mice, only the aqueous fraction of Baccharis trimera (2000 mg/kg, twice daily, per os) reduced the glycaemia after a 7-day treatment. This effect was not associated with a body weight reduction. The results suggest that Baccharis trimera presents a potential antidiabetic activity and indicate that food intake and body weight must be determined when evaluating metabolic parameters after prolonged administration of plant extracts.

  3. On the possibility to affect the course of glycaemia, insulinaemia, and perceived hunger/satiety to bread meals in healthy volunteers.

    PubMed

    Ekström, Linda M N K; Björck, Inger M E; Ostman, Elin M

    2013-04-25

    Frequent hyperglycaemia is associated with oxidative stress and subclinical inflammation, and thus increased risk of cardiovascular disease. Possibilities of modulating glycaemia, insulinaemia and perceived satiety for bread products were investigated, with emphasis on the course of glycaemia expressed as a glycaemic profile (defined as the duration of the glucose curve above the fasting concentration divided by the incremental glucose peak). For this purpose white wheat bread was supplemented with whole grain corn flour with an elevated amylose content and different types and levels of guar gum. The bread products were characterised in vitro for release of starch degradation products and content of resistant starch. Fibre related fluidity following enzyme hydrolysis was also studied. By combining medium weight guar gum and whole grain corn flour with an elevated amylose content, the course of glycaemia, insulinaemia and subjective appetite ratings were improved compared to the reference white wheat bread. In addition, the combination beneficially influenced the content of resistant starch. Fluidity measurements showed potential to predict the glycaemic profile.

  4. Self-powered microneedle-based biosensors for pain-free high-accuracy measurement of glycaemia in interstitial fluid.

    PubMed

    Strambini, L M; Longo, A; Scarano, S; Prescimone, T; Palchetti, I; Minunni, M; Giannessi, D; Barillaro, G

    2015-04-15

    In this work a novel self-powered microneedle-based transdermal biosensor for pain-free high-accuracy real-time measurement of glycaemia in interstitial fluid (ISF) is reported. The proposed transdermal biosensor makes use of an array of silicon-dioxide hollow microneedles that are about one order of magnitude both smaller (borehole down to 4µm) and more densely-packed (up to 1×10(6)needles/cm(2)) than state-of-the-art microneedles used for biosensing so far. This allows self-powered (i.e. pump-free) uptake of ISF to be carried out with high efficacy and reliability in a few seconds (uptake rate up to 1µl/s) by exploiting capillarity in the microneedles. By coupling the microneedles operating under capillary-action with an enzymatic glucose biosensor integrated on the back-side of the needle-chip, glucose measurements are performed with high accuracy (±20% of the actual glucose level for 96% of measures) and reproducibility (coefficient of variation 8.56%) in real-time (30s) over the range 0-630mg/dl, thus significantly improving microneedle-based biosensor performance with respect to the state-of-the-art.

  5. Association of Admission Glycaemia With High Grade Atrioventricular Block in ST-Segment Elevation Myocardial Infarction Undergoing Reperfusion Therapy: An Observational Study.

    PubMed

    Huang, Bi; Wang, Xinjie; Yang, Yanmin; Zhu, Jun; Liang, Yan; Tan, Huiqiong; Yu, Litian; Gao, Xin; Zhang, Han; Wang, Juan

    2015-07-01

    Several studies have demonstrated the association between elevated admission glycaemia (AG) and the occurrence of some arrhythmias such as atrial fibrillation, ventricular tachycardia, and ventricular fibrillation after myocardial infarction. However, the impact of elevated AG on the high grade atrioventricular block (AVB) occurrence after ST-segment elevation myocardial infarction (STEMI) remains unclear. Included were 3359 consecutive patients with STEMI who received reperfusion therapy. The primary endpoint was the development of high grade AVB during hospital course. Patients were divided into non-diabetes mellitus (DM), newly diagnosed DM, and previously known DM according to the hemoglobin A1c level. The optimal AG value was determined by receiver operating characteristic curves analysis with AG predicting the high grade AVB occurrence. The best cut-off value of AG for predicting the high grade AVB occurrence was 10.05 mmol/L by ROC curve analysis. The prevalence of AG ≥ 10.05 mmol/L in non-DM, newly diagnosed DM, and previously known DM was 15.7%, 34.1%, and 68.5%, respectively. The incidence of high grade AVB was significantly higher in patients with AG ≥ 10.05  mmol/L than <10.05  mmol/L in non-DM (5.7% vs. 2.1%, P < 0.001) and in newly diagnosed DM (10.2% vs.1.4%, P < 0.001), but was comparable in previously known DM (3.6% vs. 0.0%, P = 0.062). After multivariate adjustment, AG ≥ 10.05  mmol/L was independently associated with increased risk of high grade AVB occurrence in non-DM (HR = 1.826, 95% CI 1.073-3.107, P = 0.027) and in newly diagnosed DM (HR = 5.252, 95% CI 1.890-14.597, P = 0.001). Moreover, both AG ≥ 10.05  mmol/L and high grade AVB were independent risk factors of 30-day all cause-mortality (HR = 1.362, 95% CI 1.006-1.844, P = 0.046 and HR = 2.122, 95% CI 1.154-3.903, P = 0.015, respectively). Our study suggested that elevated AG level (≥10.05  mmol/L) might be

  6. Study design, intervention, and baseline characteristics of a group randomized trial involving a faith-based healthy eating and physical activity intervention (Walk by Faith) to reduce weight and cancer risk among overweight and obese Appalachian adults☆,☆☆

    PubMed Central

    Baltic, Ryan D.; Weier, Rory C.; Katz, Mira L.; Kennedy, Stephenie K.; Lengerich, Eugene J.; Lesko, Samuel M.; Reese, David; Roberto, Karen A.; Schoenberg, Nancy E.; Young, Gregory S.; Dignan, Mark B.; Paskett, Electra D.

    2017-01-01

    Background Increased prevalence of overweight and obesity among Appalachian residents may contribute to increased cancer rates in this region. This manuscript describes the design, components, and participant baseline characteristics of a faith-based study to decrease overweight and obesity among Appalachian residents. Methods A group randomized study design was used to assign 13 churches to an intervention to reduce overweight and obesity (Walk by Faith) and 15 churches to a cancer screening intervention (Ribbons of Faith). Church members with a body mass index (BMI) ≥25 were recruited from these churches in Appalachian counties in five states to participate in the study. A standard protocol was used to measure participant characteristics at baseline. The same protocol will be followed to obtain measurements after completion of the active intervention phase (12 months) and the sustainability phase (24 months). Primary outcome is change in BMI from baseline to 12 months. Secondary outcomes include changes in blood pressure, waist-to-hip ratio, and fruit and vegetable consumption, as well as intervention sustainability. Results Church members (n = 664) from 28 churches enrolled in the study. At baseline 64.3% of the participants were obese (BMI ≥30), less than half (41.6%) reported regular exercise, and 85.5% reported consuming less than 5 servings of fruits and vegetables per day. Conclusions Church members recruited to participate in a faith-based study across the Appalachian region reported high rates of unhealthy behaviors. We have demonstrated the feasibility of developing and recruiting participants to a faith-based intervention aimed at improving diet and increasing exercise among underserved populations. PMID:26115879

  7. Study design, intervention, and baseline characteristics of a group randomized trial involving a faith-based healthy eating and physical activity intervention (Walk by Faith) to reduce weight and cancer risk among overweight and obese Appalachian adults.

    PubMed

    Baltic, Ryan D; Weier, Rory C; Katz, Mira L; Kennedy, Stephenie K; Lengerich, Eugene J; Lesko, Samuel M; Reese, David; Roberto, Karen A; Schoenberg, Nancy E; Young, Gregory S; Dignan, Mark B; Paskett, Electra D

    2015-09-01

    Increased prevalence of overweight and obesity among Appalachian residents may contribute to increased cancer rates in this region. This manuscript describes the design, components, and participant baseline characteristics of a faith-based study to decrease overweight and obesity among Appalachian residents. A group randomized study design was used to assign 13 churches to an intervention to reduce overweight and obesity (Walk by Faith) and 15 churches to a cancer screening intervention (Ribbons of Faith). Church members with a body mass index (BMI) ?25 were recruited from these churches in Appalachian counties in five states to participate in the study. A standard protocol was used to measure participant characteristics at baseline. The same protocol will be followed to obtain measurements after completion of the active intervention phase (12months) and the sustainability phase (24months). Primary outcome is change in BMI from baseline to 12months. Secondary outcomes include changes in blood pressure, waist-to-hip ratio, and fruit and vegetable consumption, as well as intervention sustainability. Church members (n=664) from 28 churches enrolled in the study. At baseline 64.3% of the participants were obese (BMI?30), less than half (41.6%) reported regular exercise, and 85.5% reported consuming less than 5 servings of fruits and vegetables per day. Church members recruited to participate in a faith-based study across the Appalachian region reported high rates of unhealthy behaviors. We have demonstrated the feasibility of developing and recruiting participants to a faith-based intervention aimed at improving diet and increasing exercise among underserved populations. Copyright © 2015. Published by Elsevier Inc.

  8. Characteristics and provision of care of patients with the acute respiratory distress syndrome: descriptive findings from the DACAPO cohort baseline and comparison with international findings.

    PubMed

    Dodoo-Schittko, Frank; Brandstetter, Susanne; Brandl, Magdalena; Blecha, Sebastian; Quintel, Michael; Weber-Carstens, Steffen; Kluge, Stefan; Meybohm, Patrick; Rolfes, Caroline; Ellger, Björn; Bach, Friedhelm; Welte, Tobias; Muders, Thomas; Thomann-Hackner, Kathrin; Bein, Thomas; Apfelbacher, Christian

    2017-03-01

    Little is known about the characteristics and real world life circumstances of ARDS (acute respiratory distress syndrome) patient populations. This knowledge is essential for transferring evidence-based therapy into routine healthcare. The aim of this study was to report socio-demographic and clinical characteristics in an unselected population of ARDS patients and to compare these results to findings from other large ARDS cohorts. A German based cross-sectional observational study was carried out. A total of 700 ARDS patients were recruited in 59 study sites between September 2014 and January 2016. Socio-demographic, disease and care related variables were recorded. Additionally, characteristics of other large ARDS cohorts identified by a systematic literature search were extracted into evidence tables. Median age of ARDS patients was 58 years, 69% were male. Sixty percent had no employment, predominantly due to retirement. Seventy-one percent lived with a partner. The main cause of ARDS was a pulmonary 'direct' origin (79%). The distribution of severity was as follows: mild (14%), moderate (48%), severe (38%). Overall ICU mortality was calculated to be 34%. The observed prevalence of critical events (hypoxemia, hypoglycemia, re-intubation) was 47%. Supportive measures during ICU-treatment were applied to 60% of the patients. Other ARDS cohorts revealed a high heterogeneity in reported concomitant diseases, but sepsis and pneumonia were most frequently reported. Mean age ranged from 54 to 71 years and most patients were male. Other socio-demographic factors have been almost neglected. The proportion of patients suffering of mild ARDS was lower compared to the only study identified, which also applied the Berlin definition. The frequency of critical events during ICU treatment was high and the implementation of evidence-based therapy (prone positioning, neuro-muscular blockers) was limited. More evidence on socio-demographic characteristics and further studies

  9. The Wuhan-Zhuhai (WHZH) cohort study of environmental air particulate matter and the pathogenesis of cardiopulmonary diseases: study design, methods and baseline characteristics of the cohort.

    PubMed

    Song, Yuanchao; Hou, Jian; Huang, Xiji; Zhang, Xiaomin; Tan, Aijun; Rong, Yi; Sun, Huizhen; Zhou, Yun; Cui, Xiuqing; Yang, Yuqing; Guo, Yanjun; Zhang, Zhihong; Luo, Xin; Zhang, Bing; Hou, Fan; He, Xiaosheng; Xie, Jungang; Wu, Tangchun; Chen, Weihong; Yuan, Jing

    2014-09-24

    Particulate air pollution has been recognized to be associated with a wide range of adverse health effects, including increased mortality, morbidity, exacerbation of respiratory conditions. However, earlier physiological or pathological changes or long-term bodies' reaction to air pollutants have not been studied in depth in China. The Wuhan-Zhuhai (WHZH) cohort study is designed to investigate the association between air pollutants exposure and physiological or pathological reactions on respiratory and cardiovascular system. The cohort is a community-based prospective study that includes 4812 individuals aged 18-80 years. The collections of data were conducted from April to May 2011 in Wuhan city and in May 2012 in Zhuhai city. At baseline, data on demographic and socioeconomic information, occupational history, family disease history, lifestyle, cooking mode, daily travel mode, physical activity and living condition have been collected by questionnaires. Participants underwent an extensive physical examination, including anthropometry, spirometry, electrocardiography, and measurements of blood pressure, heart rate, exhaled nitric oxide and carbon monoxide. Potential conditions in the lung, heart, liver, spleen, and skin were synchronously performed. In addition, samples of morning urine, fasting blood serum and plasma were collected during physical health examination. DNA were extracted and were stored at -80°C. Environment concentrations of particulate matter and chemicals were determined for 15 days in each of four seasons. Participants are followed for physiological or pathological changes or incidence of cardiopulmonary diseases every 3 years. The results obtained in WHZH cohort study may increase a better understanding of the relationship between particulate air pollution and its components and possible health damages. And the potential mechanisms underlying the development of cardiopulmonary diseases has implications for the development of prevention and

  10. Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo.

    PubMed

    Bentley-Lewis, Rhonda; Aguilar, David; Riddle, Matthew C; Claggett, Brian; Diaz, Rafael; Dickstein, Kenneth; Gerstein, Hertzel C; Johnston, Peter; Køber, Lars V; Lawson, Francesca; Lewis, Eldrin F; Maggioni, Aldo P; McMurray, John J V; Ping, Lin; Probstfield, Jeffrey L; Solomon, Scott D; Tardif, Jean-Claude; Wu, Yujun; Pfeffer, Marc A

    2015-05-01

    Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagon-like peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk. Copyright © 2015. Published by Elsevier Inc.

  11. Indiana Cancer Pain and Depression (INCPAD) Trial Design of a Telecare Management Intervention for Cancer-Related Symptoms and Baseline Characteristics of Study Participants

    PubMed Central

    Kroenke, Kurt; Theobald, Dale; Norton, Kelli; Sanders, Rebecca; Schlundt, Susan; McCalley, Stephanie; Harvey, Pamela; Iseminger, Karen; Morrison, Gwendolyn; Carpenter, Janet S.; Stubbs, Dawana; Jacks, Rakeva; Carney-Doebbeling, Caroline; Wu, Jingwei; Tu, Wanzhu

    2009-01-01

    Objective Pain and depression are two of the most prevalent and treatable cancer-related symptoms, each present in at least 20-30% of oncology patients. Both symptoms, however, are frequently either unrecognized and/or undertreated. The objective is to describe a telecare management intervention delivered by a nurse-psychiatrist team that is designed to improve recognition and treatment of pain and depression. The enrolled sample is also described. Method The Indiana Cancer Pain and Depression (INCPAD) study is an NCI-sponsored randomized clinical trial. A total of 405 patients with cancer-related pain and/or clinically significant depression from 16 urban or rural oncology practices throughout Indiana have been enrolled and randomized to either the intervention or a usual care control group. Intervention patients receive centralized telecare management coupled with automated home-based symptom monitoring. Outcomes will be assessed at 1, 3, 6 and 12 months by research assistants blinded to treatment arm. Results Of 4465 patients screened, 2185 (49%) endorsed symptoms of pain or depression. Of screen-positive patients, about one-third were ineligible (most commonly due to pain or depression not meeting severity thresholds, or pain that is not cancer-related). Of the 405 patients enrolled, 32% have depression only, 24% pain only, and 44% both depression and pain. At baseline, participants report an average of 16.8 days out of the past 4 weeks in which they were confined to bed or had to reduce their usual activities by ≥ 50% due to pain or depression. Also, 176 (44%) report being unable to work due to health reasons. Conclusions When completed, the INCPAD trial will test whether centralized telecare management coupled with automated home-based symptom monitoring improves outcomes in cancer patients with depression and/or pain. Findings will be important for both oncologists and mental health clinicians confronted with oncology patients' depression or pain. PMID

  12. The Australian Imaging, Biomarkers and Lifestyle (AIBL) study of aging: methodology and baseline characteristics of 1112 individuals recruited for a longitudinal study of Alzheimer's disease.

    PubMed

    Ellis, Kathryn A; Bush, Ashley I; Darby, David; De Fazio, Daniela; Foster, Jonathan; Hudson, Peter; Lautenschlager, Nicola T; Lenzo, Nat; Martins, Ralph N; Maruff, Paul; Masters, Colin; Milner, Andrew; Pike, Kerryn; Rowe, Christopher; Savage, Greg; Szoeke, Cassandra; Taddei, Kevin; Villemagne, Victor; Woodward, Michael; Ames, David

    2009-08-01

    The Australian Imaging, Biomarkers and Lifestyle (AIBL) flagship study of aging aimed to recruit 1000 individuals aged over 60 to assist with prospective research into Alzheimer's disease (AD). This paper describes the recruitment of the cohort and gives information about the study methodology, baseline demography, diagnoses, medical comorbidities, medication use, and cognitive function of the participants. Volunteers underwent a screening interview, had comprehensive cognitive testing, gave 80 ml of blood, and completed health and lifestyle questionnaires. One quarter of the sample also underwent amyloid PET brain imaging with Pittsburgh compound B (PiB PET) and MRI brain imaging, and a subgroup of 10% had ActiGraph activity monitoring and body composition scanning. A total of 1166 volunteers were recruited, 54 of whom were excluded from further study due to comorbid disorders which could affect cognition or because of withdrawal of consent. Participants with AD (211) had neuropsychological profiles which were consistent with AD, and were more impaired than participants with mild cognitive impairment (133) or healthy controls (768), who performed within expected norms for age on neuropsychological testing. PiB PET scans were performed on 287 participants, 100 had DEXA scans and 91 participated in ActiGraph monitoring. The participants comprising the AIBL cohort represent a group of highly motivated and well-characterized individuals who represent a unique resource for the study of AD. They will be reassessed at 18-month intervals in order to determine the predictive utility of various biomarkers, cognitive parameters and lifestyle factors as indicators of AD, and as predictors of future cognitive decline.

  13. Baseline reach and adoption characteristics in a randomized controlled trial of two weight loss interventions translated into primary care: A structured report of real-world applicability

    PubMed Central

    Yank, Veronica; Stafford, Randall S.; Rosas, Lisa Goldman; Ma, Jun

    2012-01-01

    Background Although the Diabetes Prevention Program (DPP) lifestyle intervention reduced type 2 diabetes incidence by 58% among high-risk adults at academic centers, it requires translation into typical primary care settings. Using baseline data from the Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care (E-LITE) randomized controlled trial, we evaluated the potential of its two DPP-based interventions to reach their target populations and be adopted into routine use. Methods Overweight/obese adults with increased cardiometabolic risk enrolled from one primary care clinic. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) model, we assessed reach with data on patient identification, participation, and representativeness, and adoption with data on intervention feasibility and potential for organizational diffusion. Results The target population was identified by searching electronic health records. Contact was attempted for 2391 patients who completed initial screening by phone (56% uptake) or online (44%). Most (88%) of those screened ineligible were not within the target population; 12% were excluded because of research requirements. Conservatively estimated participation rate was 44%. Participants (n=241) included 54% men and had a mean (SD) age of 52.9 years (10.6) and body mass index of 32 kg/m2 (5.4). Regarding adoption, all clinic physicians agreed to participate. The feasibility of intervention implementation and dissemination was enhanced by leveraging existing intervention, training, and primary care resources. Conclusions E-LITE's lifestyle interventions had fair-to-good potential for primary care reach and adoption. Our trial evidence and structured reporting may inform real-world implementation of translational trials by health networks, physicians, and payers. PMID:23124047

  14. Diabetes Nurse Case Management and Motivational Interviewing for Change (DYNAMIC): Study Design and Baseline Characteristics in the Chronic Care Model for Type 2 Diabetes

    PubMed Central

    Stuckey, Heather L.; Dellasega, Cheryl; Graber, Nora J.; Mauger, David T.; Lendel, Irina; Gabbay, Robert A.

    2009-01-01

    Background Despite evidence that diabetes is costly and devastating, the health care system is poorly equipped to meet the challenges of chronic disease care. The Penn State Institute of Diabetes & Obesity is evaluating a model of managing Type 2 DM which includes nurse case management (NCM) and motivational interviewing (MI) to foster behavior change. The primary care intervention is designed to improve patients' self care and to reduce clinical inertia through provider use of standardized clinical guidelines to achieve better diabetes outcomes. Methods This RCT tests the efficacy of an enhanced NCM intervention on Type 2 DM (n=549) patient outcomes mediated by changes in self-care behavior and diabetes management. Outcome measures include: (a) effect on clinical parameters such as HbA1c (<7), BP (<130/80), and LDL (<100), depression scores and weight; (b) process measures such as complication screening; (c) patient psychological and behavioral outcomes as measured by emotional distress (PAID), diabetes-specific quality of life (ADDQoL), patient satisfaction (DTSQ), self-care activities (SDSCA); and (d) physician satisfaction and cost-effectiveness of the intervention. Conclusions Baseline includes (mean) age = 58; BMI = 34.4; 57% females; 47% Caucasian, and 39% Hispanic. Patients had elevated HbA1c (8.4), BP (137/77) and LDL (114). Overall, patients were depressed (CES-D = 21.6) and had an extremely negative quality of life (ADDQoL = -1.58). We believe that enhanced NCM will both improve self-care and reduce emotional distress for patients with diabetes. If proven effective, enhanced NCM may be translated to other chronic illnesses. PMID:19328244

  15. The Epidemiology of Scabies and Impetigo in Relation to Demographic and Residential Characteristics: Baseline Findings from the Skin Health Intervention Fiji Trial.

    PubMed

    Romani, Lucia; Whitfeld, Margot J; Koroivueta, Josefa; Kama, Mike; Wand, Handan; Tikoduadua, Lisi; Tuicakau, Meciusela; Koroi, Aminiasi; Ritova, Raijieli; Andrews, Ross; Kaldor, John M; Steer, Andrew C

    2017-07-17

    Scabies and associated impetigo are under-recognised causes of morbidity in many developing countries. To strengthen the evidence base for scabies control we undertook a trial of mass treatment for scabies. We report on the occurrence and predictors of scabies and impetigo in participants at baseline. Participants were recruited in six island communities and were examined for the presence of scabies and impetigo. In addition to descriptive analyses, logistic regression models were fit to assess the association between demographic variables and outcome of interest. The study enrolled 2051 participants. Scabies prevalence was 36.4% (95% CI 34.3-38.5), highest in children 5-9 years (55.7%). Impetigo prevalence was 23.4% (95% CI 21.5-25.2) highest in children aged 10-14 (39.0%). People with scabies were 2.8 times more likely to have impetigo. The population attributable risk of scabies as a cause of impetigo was 36.3% and 71.0% in children aged less than five years. Households with four or more people sharing the same room were more likely to have scabies and impetigo (OR 1.6, 95% CI 1.2-2.2 and OR 2.3, 95% CI 1.6-3.2 respectively) compared to households with rooms occupied by a single individual. This study confirms the high burden of scabies and impetigo in Fiji and the association between these two conditions, particularly in young children. Overcrowding, young age and clinical distribution of lesion are important risk factors for scabies and impetigo. Further studies are needed to investigate whether the decline of endemic scabies would translate into a definite reduction of the burden of associated complications.

  16. Design and baseline characteristics of participants in the Enhancing Physical Activity and Reducing Obesity through Smartcare and Financial Incentives (EPAROSFI): A pilot randomized controlled trial.

    PubMed

    Shin, Dong Wook; Joh, Hee-Kyung; Yun, Jae Moon; Kwon, Hyuk Tae; Lee, Hyejin; Min, Hyeyeon; Shin, Jung-Hyun; Chung, Won Joo; Park, Jin Ho; Cho, BeLong

    2016-03-01

    An activity tracker combined with a smartphone application (smartcare) may help people track and receive feedback on their own activities. However, activity trackers themselves generally fail to drive long-term sustained engagement for a majority of users. One potential strategy for increasing the effectiveness of smartcare is through the use of incentives. The purpose of this pilot randomized trial is to test the feasibility of our intervention and to assess the extent to which smartcare with or without financial incentives can increase physical activity levels and reduce weight over a 12-week period. This study employs a three-arm, open-label randomized controlled trial design: control (standard basic education), smartcare, and smartcare plus financial incentives. Male university students with body mass index ≥ 27 are enrolled. Our primary and secondary endpoints are the amount of weight loss and the level of physical activity respectively. The weight loss goal is 3% of baseline at week 4, 5% at week 8, and 7% at week 12. The daily physical activity goal was individualized according to the participants' weight. Process incentives are accumulated when participants met daily physical activity goals, and outcome incentives are provided when they met weight reduction goals. Given the global increase in physical inactivity and obesity, there is a growing need for effective, scalable, and affordable health promotion strategies. Our proof-of-concept study will provide the evidence for the combination of rising health promotion technology of activity trackers and smartphone applications with the modern concept of behavioral economics using financial incentives. Copyright © 2015. Published by Elsevier Inc.

  17. Demography, baseline disease characteristics and treatment history of patients with psoriasis enrolled in a multicentre, prospective, disease-based registry (PSOLAR)*

    PubMed Central

    Kimball, AB; Leonardi, C; Stahle, M; Gulliver, W; Chevrier, M; Fakharzadeh, S; Goyal, K; Calabro, S; Langholff, W; Menter, A

    2014-01-01

    Summary Background Psoriasis is associated with several comorbidities and behavioural risk factors. Objectives To evaluate demographic and disease characteristics in patients enrolled in the Psoriasis Longitudinal Assessment and Registry (PSOLAR). Methods PSOLAR is a global, prospective, longitudinal, disease-based registry that includes a postmarketing commitment to evaluate safety in patients with psoriasis. Enrolled patients had to be receiving, or be eligible to receive, conventional systemic or biological agents. Demographic/disease characteristics, medical histories, lifestyle risk factors and previous treatments are collected at enrolment. Efficacy and safety data are collected every 6 months for 8 years, and data are extracted annually. Selected parameters are evaluated by age quartile using post hoc analyses. Results As of 23 August 2012, 11 900 patients were enrolled at 301 sites in North America, Europe and Latin America. Over half of the PSOLAR population (54·7%) is male, with a mean age of 48·6 years and mean body mass index of 30·9 kg m−2 at enrolment. Mean duration of disease at enrolment was 17·5 years, and mean Physician's Global Assessment score was 2·0. Psoriatic arthritis (35·5%) and cardiovascular diseases (38·2%) were highly prevalent. Diabetes mellitus type II was reported in 11·4% of patients. Depression and anxiety were noted in 14·7% and 11·1% of patients, respectively; 79·0% reported any alcohol use and 56·7% reported smoking or a history of smoking. The occurrence of most comorbidities, including cardiovascular disease and risk factors, increased with age. Conclusions In the PSOLAR population, multiple and age-appropriate comorbidities are associated with psoriasis and may affect the selection of psoriasis treatments. What's already known about this topic? Psoriasis is a complicated disorder, often accompanied by multiple comorbidities. Demographic and disease characteristics of patients with psoriasis reported from

  18. Effect of chronic coffee consumption on weight gain and glycaemia in a mouse model of obesity and type 2 diabetes.

    PubMed

    Rustenbeck, I; Lier-Glaubitz, V; Willenborg, M; Eggert, F; Engelhardt, U; Jörns, A

    2014-06-30

    Epidemiological evidence shows that chronic coffee consumption in humans is correlated with a lower incidence of type 2 diabetes mellitus. For the experimental exploration of the underlying mechanisms, this effect needs to be replicated in an animal model of type 2 diabetes with a short lifespan. Male C57BL/6 mice consumed regular coffee or water ad libitum and the development of obesity and diabetes caused by high-fat diet (55% lipids, HFD) was observed from week 10 on for 35 weeks in comparison with mice feeding on a defined normal diet (9% lipids, ND). The massive weight gain in HFD mice was dose-dependently retarded (P=0.034), the moderate weight gain in ND mice was abolished (P<0.001) by coffee consumption, probably because of a lower feeding efficiency. The consumption of fluid (water or coffee) was significantly diminished by HFD (P<0.001), resulting in a higher coffee exposure of ND mice. On week 21 intraperitoneal glucose tolerance tests (IPGTT) showed a dose-dependent faster decline of elevated glucose levels in coffee-consuming HFD mice (P=0.016), but not in ND mice. Remarkably, a spontaneous decrease in non-fasting glycaemia occurred after week 21 in all treatment groups (P<0.001). On week 39 the IPGTT showed diminished peak of glucose levels in coffee-consuming HFD mice (P<0.05). HFD mice were hyperinsulinaemic and had significantly (P<0.001) enlarged islets. Coffee consumption did not affect islet size or parameters of beta-cell apoptosis, proliferation and insulin granule content. Coffee consumption retarded weight gain and improved glucose tolerance in a mouse model of type 2 diabetes and corresponding controls. This gives rise to the expectation that further insight into the mechanism of the diabetes-preventive effect of coffee consumption in humans may be gained by this approach.

  19. Effect of chronic coffee consumption on weight gain and glycaemia in a mouse model of obesity and type 2 diabetes

    PubMed Central

    Rustenbeck, I; Lier-Glaubitz, V; Willenborg, M; Eggert, F; Engelhardt, U; Jörns, A

    2014-01-01

    Objective: Epidemiological evidence shows that chronic coffee consumption in humans is correlated with a lower incidence of type 2 diabetes mellitus. For the experimental exploration of the underlying mechanisms, this effect needs to be replicated in an animal model of type 2 diabetes with a short lifespan. Design: Male C57BL/6 mice consumed regular coffee or water ad libitum and the development of obesity and diabetes caused by high-fat diet (55% lipids, HFD) was observed from week 10 on for 35 weeks in comparison with mice feeding on a defined normal diet (9% lipids, ND). Results: The massive weight gain in HFD mice was dose-dependently retarded (P=0.034), the moderate weight gain in ND mice was abolished (P<0.001) by coffee consumption, probably because of a lower feeding efficiency. The consumption of fluid (water or coffee) was significantly diminished by HFD (P<0.001), resulting in a higher coffee exposure of ND mice. On week 21 intraperitoneal glucose tolerance tests (IPGTT) showed a dose-dependent faster decline of elevated glucose levels in coffee-consuming HFD mice (P=0.016), but not in ND mice. Remarkably, a spontaneous decrease in non-fasting glycaemia occurred after week 21 in all treatment groups (P<0.001). On week 39 the IPGTT showed diminished peak of glucose levels in coffee-consuming HFD mice (P<0.05). HFD mice were hyperinsulinaemic and had significantly (P<0.001) enlarged islets. Coffee consumption did not affect islet size or parameters of beta-cell apoptosis, proliferation and insulin granule content. Conclusion: Coffee consumption retarded weight gain and improved glucose tolerance in a mouse model of type 2 diabetes and corresponding controls. This gives rise to the expectation that further insight into the mechanism of the diabetes-preventive effect of coffee consumption in humans may be gained by this approach. PMID:24979152

  20. Is there evidence of potential overtreatment of glycaemia in elderly people with type 2 diabetes? Data from the GUIDANCE study.

    PubMed

    Müller, Nicolle; Khunti, Kamlesh; Kuss, Oliver; Lindblad, Ulf; Nolan, John J; Rutten, Guy Ehm; Trento, Marina; Porta, Massimo; Roth, Johannes; Charpentier, Guillaume; Jörgens, Viktor; Müller, Ulrich A

    2017-02-01

    We used data from the GUIDANCE Study to determine the care of people with type 2 diabetes according to age and accompanying cardiovascular diseases and to assess indicators of overtreatment of glycaemia. The GUIDANCE study was a retrospective, cross-sectional study from 2009-2010 based on the records of 7597 people in France, Belgium, Italy, the Netherlands, Sweden, UK, Ireland and Germany. We analysed the level of metabolic control achieved and blood glucose-lowering medication used in different age groups and in relation to accompanying diseases. 4.459 patients (59.1%) were 65 years or older. Their HbA1c levels were similar to those with <65 years. 44.7% of patients ≥65 years had an HbA1c ≤7% (53 mmol/mol) and were treated with insulin or sulfonylureas, and 27.1% of them had ischaemic heart disease or congestive heart failure. Significantly more patients with heart disease had HbA1c values ≤7% (53 mmol/mol) and were treated more often with insulin or sulfonylureas compared to patients of the same age without heart disease. Most patients were treated according to guidelines valid at the time this large international patient sample was surveyed. Older and younger patients were at a similar level of metabolic control, and almost half of the patients with an age of ≥65 years and treated with insulin or sulfonylurea had HbA1c levels below the target range (≤7%) for younger patients. However, these patients have an increased risk of severe hypoglycaemic events with potentially dangerous complications, particularly in those with cardiovascular diseases.

  1. Effects of Charitable Versus Monetary Incentives on the Acceptance of and Adherence to a Pedometer-Based Health Intervention: Study Protocol and Baseline Characteristics of a Cluster-Randomized Controlled Trial

    PubMed Central

    Kramer, Jan-Niklas; Kehr, Flavius; Wahle, Fabian; Elser, Niklas; Fleisch, Elgar

    2016-01-01

    Background Research has so far benefited from the use of pedometers in physical activity interventions. However, when public health institutions (eg, insurance companies) implement pedometer-based interventions in practice, people may refrain from participating due to privacy concerns. This might greatly limit the applicability of such interventions. Financial incentives have been successfully used to influence both health behavior and privacy concerns, and may thus have a beneficial effect on the acceptance of pedometer-based interventions. Objective This paper presents the design and baseline characteristics of a cluster-randomized controlled trial that seeks to examine the effect of financial incentives on the acceptance of and adherence to a pedometer-based physical activity intervention offered by a health insurance company. Methods More than 18,000 customers of a large Swiss health insurance company were allocated to a financial incentive, a charitable incentive, or a control group and invited to participate in a health prevention program. Participants used a pedometer to track their daily physical activity over the course of 6 months. A Web-based questionnaire was administered at the beginning and at the end of the intervention and additional data was provided by the insurance company. The primary outcome of the study will be the participation rate, secondary outcomes will be adherence to the prevention program, physical activity, and health status of the participants among others. Results Baseline characteristics indicate that residence of participants, baseline physical activity, and subjective health should be used as covariates in the statistical analysis of the secondary outcomes of the study. Conclusions This is the first study in western cultures testing the effectiveness of financial incentives with regard to a pedometer-based health intervention offered by a large health insurer to their customers. Given that the incentives prove to be effective

  2. The Netherlands Obsessive Compulsive Disorder Association (NOCDA) study: design and rationale of a longitudinal naturalistic study of the course of OCD and clinical characteristics of the sample at baseline.

    PubMed

    Schuurmans, Josien; van Balkom, Anton J L M; van Megen, Harold J G M; Smit, Johannes H; Eikelenboom, Merijn; Cath, Danielle C; Kaarsemaker, Maarten; Oosterbaan, Desiree; Hendriks, Gert-Jan; Schruers, Koen R J; van der Wee, Nic J A; Glas, Gerrit; van Oppen, Patricia

    2012-12-01

    In half of Obsessive Compulsive Disorder (OCD) patients the disorder runs a chronic course despite treatment. The factors determining this unfavourable outcome remain unknown. The Netherlands Obsessive Compulsive Disorder Association (NOCDA) study is a multicentre naturalistic cohort study of the biological, psychological and social determinants of chronicity in a clinical sample. Recruitment of OCD patients took place in mental health organizations. Its design is a six-year longitudinal cohort study among a representative clinical sample of 419 OCD patients. All five measurements within this six-year period involved validated semi-structured interviews and self-report questionnaires which gathered information on the severity of OCD and its co-morbidity as well as information on general wellbeing, quality of life, daily activities, medical consumption and key psychological and social factors. The baseline measurements also include DNA and blood sampling and data on demographic and personality variables. The current paper presents the design and rationale of the study, as well as data on baseline sample characteristics. Demographic characteristics and co-morbidity ratings in the NOCDA sample closely resemble other OCD study samples. Lifetime co-morbid Axis I disorders are present in the majority of OCD patients, with high current and lifetime co-morbidity ratings for affective disorders (23.4% and 63.7%, respectively) and anxiety disorders other than OCD (36% current and 46.5% lifetime).

  3. Types of adult attention-deficit hyperactivity disorder (ADHD): baseline characteristics, initial response, and long-term response to treatment with methylphenidate.

    PubMed

    Reimherr, Fred W; Marchant, Barrie K; Gift, Thomas E; Steans, Tammy A; Wender, Paul H

    2015-06-01

    Much recent research describes the importance of emotional symptoms in ADHD. While there is no accepted system for including emotionality in diagnosing ADHD, the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) provides a tool to facilitate this. It assesses a range of adult ADHD symptoms which load on two factors: inattentive and emotional dysregulation. The consistently high inattentive factor was used to define significant elevation on the more variable emotional dysregulation factor (which contains four WRAADDS domains: hyperactivity/restlessness, temper, affective lability, and emotional over-reactivity) allowing the definition of two ADHD diagnostic types. We compared these two types on a broad range of adult subject characteristics, including response to methylphenidate (MPH) treatment assessed during two clinical trials. Marked impairment in three of the four emotional domains reflected a symptom severity level equivalent to that of the inattentive factor. 59 % met this threshold, defining them as ADHD emotion dysregulation presentation, as opposed to 41 % with ADHD inattentive presentation. Cluster analysis validated these groups by generating similar clusters with 85 % agreement regarding membership. ADHD emotional dysregulation presentation subjects showed more childhood ADHD symptoms, adult symptoms of oppositional defiant disorder, and evidence of personality disorder. Both types showed similar improvement during the double-blind MPH arm of the trials and during a 6-month open-label phase. Based on the presence of symptoms of emotional dysregulation, ADHD in adults can be conceptualized as two types. Impairment and comorbidity in adults with ADHD are largely concentrated in ADHD emotional dysregulation presentation patients.

  4. Characteristics, cycling patterns, and crash and injury experiences at baseline of a cohort of transport and recreational cyclists in New South Wales, Australia.

    PubMed

    Poulos, R G; Hatfield, J; Rissel, C; Flack, L K; Murphy, S; Grzebieta, R; McIntosh, A S

    2015-05-01

    This paper examines self-reported retrospective data for a 12 month period from 2038 adult cyclists from New South Wales (Australia), and compares cyclists according to whether they self-identify as riding mainly for transport or mainly for recreation. Statistically significant differences were found in the demographic characteristics, cycling patterns, and crash experiences between these two groups of cyclists. Transport cyclists tended to be younger, travel more days per week, and within morning and evening peak hours than recreational cyclists; recreational cyclists were more likely to identify fitness as a purpose for cycling. The proportion of cyclists experiencing a crash or crash-related injury in the previous 12 months was similar for transport and recreational cyclists, but there were differences in crash types and location which likely reflect different cycling environments. Heterogeneity within transport and recreational cyclists was also found, based on self-reported riding intensity. An understanding of the different cycling patterns and experiences of various types of cyclists is useful to inform road safety, transport and health promotion policy. Copyright © 2015 Elsevier Ltd. All rights reserved.

  5. The expanded Global Registry of Acute Coronary Events: baseline characteristics, management practices, and hospital outcomes of patients with acute coronary syndromes.

    PubMed

    Goodman, Shaun G; Huang, Wei; Yan, Andrew T; Budaj, Andrzej; Kennelly, Brian M; Gore, Joel M; Fox, Keith A A; Goldberg, Robert J; Anderson, Frederick A

    2009-08-01

    The Global Registry of Acute Coronary Events (GRACE)-a prospective, multinational study of patients hospitalized with acute coronary syndromes (ACSs)-was designed to improve the quality of care for patients with an ACS. Expanded GRACE aims to test the feasibility of a simplified data collection tool and provision of quarterly feedback to index individual hospital management practices to an international reference cohort. We describe the objectives; study design; study and data management; and the characteristics, management, and hospital outcomes of patients > or =18 years old enrolled with a presumptive diagnosis of ACS. From 2001 to 2007, 31,982 patients were enrolled at 184 hospitals in 25 countries; 30% were diagnosed with ST-segment elevation myocardial infarction, 31% with non-ST-segment myocardial infarction, 26% with unstable angina, and 12% with another cardiac/noncardiac final diagnosis. The median age was 65 (interquartile range 55-75) years; 24% were >75 years old, and 33% were women. In general, increases were observed over time across the spectrum of ACS (1) in the use in the first 24 hours and at discharge of aspirin, clopidogrel, beta-blockers, and angiotensin-converting enzyme inhibitors/receptor blockers; (2) in the use at discharge of statins; (3) in the early use of glycoprotein IIb/IIIa inhibitors and low-molecular-weight heparin; and (4) in the use of cardiac catheterization and percutaneous coronary intervention. An increase in the use of primary percutaneous coronary intervention and a similar decrease in the use of fibrinolysis in ST-segment elevation myocardial infarction were also seen. Over the course of 7 years, general increases in the use of evidence-based therapies for ACS patients were observed in the expanded GRACE.

  6. Polychlorinated Biphenyls, Glycaemia and Diabetes in a Population Living in a Highly Polychlorinated Biphenyls-Polluted Area in Northern Italy: a Cross-sectional and Cohort Study

    PubMed Central

    Zani, Claudia; Donato, Francesco; Magoni, Michele; Feretti, Donatella; Covolo, Loredana; Vassallo, Francesco; Speziani, Fabrizio; Scarcella, Carmelo; Bergonzi, Roberto; Apostoli, Pietro

    2013-01-01

    Conflicts of interests: the authors declare no potential conflict of interests. Background Polychlorinated biphenyls (PCBs) have been found to be associated with diabetes in some, but not all, studies performed so far. The aim of this study was to assess the association between PCB serum levels and glycaemia and diabetes in people living in Brescia, a highly industrialised PCB-polluted town in Northern Italy. Design and Methods 527 subjects were enrolled in a cross-sectional population-based study: they were interviewed face-to-face in 2003 and also provided a blood sample under fasting conditions. The concentration of 24 PCB congeners was determined using gas-chromatography (GC/MS). Subsequently, all subjects were included in a follow-up (cohort) study. According to the Local Health Authority health-care database, subjects were considered to be diabetic if they had diabetes at interview time (prevalent cases) or during a 7-year follow-up (incident cases). Results A total of 53 subjects (10.0%) were diabetics: 28 had diabetes at enrolment and other 25 developed the disease subsequently. Diabetes frequency increased according to the serum concentrations of total PCBs and single PCB congeners, but no association was found when estimates were adjusted for education, body mass index, age and gender by logistic regression analysis. Accordingly, glycaemia increased with PCB serum levels, but no association was observed when multiple regression analysis, including confounding factors, was performed. Conclusions This study does not support the hypothesis that PCB environmental exposure is strictly associated with diabetes or glycaemia. PMID:25170473

  7. Differences by sex in the prevalence of diabetes mellitus, impaired fasting glycaemia and impaired glucose tolerance in sub-Saharan Africa: a systematic review and meta-analysis

    PubMed Central

    Yatsuya, Hiroshi; Kawaguchi, Leo; Aoyama, Atsuko

    2013-01-01

    Abstract Objective To assess differences between men and women in the prevalence of diabetes mellitus, impaired fasting glycaemia and impaired glucose tolerance in sub-Saharan Africa. Methods In September 2011, the PubMed and Web of Science databases were searched for community-based, cross-sectional studies providing sex-specific prevalences of any of the three study conditions among adults living in parts of sub-Saharan Africa (i.e. in Eastern, Middle and Southern Africa according to the United Nations subregional classification for African countries). A random-effects model was then used to calculate and compare the odds of men and women having each condition. Findings In a meta-analysis of the 36 relevant, cross-sectional data sets that were identified, impaired fasting glycaemia was found to be more common in men than in women (OR: 1.56; 95% confidence interval, CI: 1.20–2.03), whereas impaired glucose tolerance was found to be less common in men than in women (OR: 0.84; 95% CI: 0.72–0.98). The prevalence of diabetes mellitus – which was generally similar in both sexes (OR: 1.01; 95% CI: 0.91–1.11) – was higher among the women in Southern Africa than among the men from the same subregion and lower among the women from Eastern and Middle Africa and from low-income countries of sub-Saharan Africa than among the corresponding men. Conclusion Compared with women in the same subregions, men in Eastern, Middle and Southern Africa were found to have a similar overall prevalence of diabetes mellitus but were more likely to have impaired fasting glycaemia and less likely to have impaired glucose tolerance. PMID:24101783

  8. Acute regulation of pancreatic islet microcirculation and glycaemia by telmisartan and ramipril: discordant effects between normal and type 2 diabetic rats.

    PubMed

    Olverling, Anna; Huang, Zhen; Nyström, Thomas; Sjöholm, Åke

    2013-11-01

    Diabetic patients are often treated with an ACEi (angiotensin-converting enzyme inhibitor) or angiotensin receptor antagonist against hypertension or albuminuria. These drugs also have a positive impact on glucose tolerance, but the mechanism for this remains elusive. Hypothesizing a positive non-additive effect, we studied whether the angiotensin receptor antagonist telmisartan or the ACEi ramipril acutely influence insulin secretion and glycaemia in vivo in healthy and Type 2 diabetic rats through effects on islet blood perfusion. Telmisartan and ramipril were injected intravenously into anaesthetized non-diabetic Wistar rats or Type 2 diabetic GK (Goto-Kakizaki) rats. In non-diabetic Wistar rats, neither whole PBF (pancreatic blood flow) nor IBF (islet blood flow) were significantly influenced by telmisartan and ramipril, alone or in combination. Renal blood flow was enhanced significantly by telmisartan and ramipril when used in combination, whereas ABF (adrenal blood flow) was not affected by any of the drugs. Telmisartan and ramipril both significantly increased serum insulin levels, but did not influence glycaemia. In Type 2 diabetic GK rats, both whole PBF and IBF were significantly decreased by telmisartan and ramipril, but only when used in combination. Renal blood flow was enhanced significantly by telmisartan and ramipril alone, but not when used in combination, whereas ABF was not affected by any of the drugs. Telmisartan and ramipril both significantly decreased serum insulin levels, and non-additively elevated blood glucose levels. In conclusion, the present study suggests that a local pancreatic RAS (renin-angiotensin system), sensitive to acute administration of telmisartan and ramipril, controls pancreatic IBF and insulin secretion and thereby has an impact on glucose tolerance. Our findings indicate unexpected significant differences in the effects of these agents on islet microcirculation, in vivo insulin secretion and glycaemia between healthy

  9. Rationale, design, and baseline characteristics of ARTS-DN: a randomized study to assess the safety and efficacy of finerenone in patients with type 2 diabetes mellitus and a clinical diagnosis of diabetic nephropathy.

    PubMed

    Ruilope, Luis M; Agarwal, Rajiv; Chan, Juliana C; Cooper, Mark E; Gansevoort, Ron T; Haller, Hermann; Remuzzi, Giuseppe; Rossing, Peter; Schmieder, Roland E; Nowack, Christina; Ferreira, Anna C; Pieper, Alexander; Kimmeskamp-Kirschbaum, Nina; Bakris, George L

    2014-01-01

    Finerenone decreases albuminuria in patients having heart failure with reduced ejection fraction and mild-to-moderate (stage 2-3) chronic kidney disease. The MinerAlocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN; NCT01874431) is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 2b study. ARTS-DN investigated whether the mineralocorticoid receptor antagonist finerenone reduces albuminuria without causing major alterations in serum potassium levels in patients with type 2 diabetes mellitus and a clinical diagnosis of DN who were receiving a renin-angiotensin-system (RAS) inhibitor. Patients were randomized to oral finerenone 1.25-20 mg or placebo once daily. The primary objectives were to assess the ratio of the urinary albumin-to-creatinine ratio at day 90 to that at baseline in patients receiving finerenone, and to compare it with that in the placebo group. Additional exploratory analyses included evaluating changes from baseline in serum potassium levels, efficacy and safety biomarkers, and health-related quality of life. Of 1,501 patients screened, 821 (the sample population) received at least one dose of finerenone/placebo. Baseline characteristics included: male, 77.8%; white, 84.2%; very high albuminuria (formerly macroalbuminuria), 38.4%; high albuminuria (formerly microalbuminuria), 60.3%; median (range) estimated glomerular filtration rate, 66.3 (24.5-130.7) ml/min/1.73 m(2); and systolic blood pressure (mean ± standard deviation), 138.1 ± 14.4 mm Hg. There was a history of cardiovascular disease in 39.6%, diabetic neuropathy in 20.0%, and diabetic retinopathy in 19.9% of patients. ARTS-DN is the first phase 2b trial of finerenone in combination with a RAS inhibitor in patients with type 2 diabetes mellitus and a clinical diagnosis of DN. © 2015 S. Karger AG, Basel.

  10. Effectiveness, safety and costs of thromboembolic prevention in patients with non-valvular atrial fibrillation: phase I ESC-FA protocol study and baseline characteristics of a cohort from a primary care electronic database

    PubMed Central

    Vedia Urgell, Cristina; Roso-Llorach, Albert; Morros, Rosa; Capellà, Dolors; Castells, Xavier; Ferreira-González, Ignacio; Troncoso Mariño, Amelia; Diògene, Eduard; Elorza, Josep Mª; Casajuana, Marc; Bolíbar, Bonaventura; Violan, Concepció

    2016-01-01

    Purpose Atrial fibrillation is the most common arrhythmia. Its management aims to reduce symptoms and to prevent complications through rate and rhythm control, management of concomitant cardiac diseases and prevention of related complications, mainly stroke. The main objective of Effectiveness, Safety and Costs in Atrial Fibrillation (ESC-FA) study is to analyse the drugs used for the management of the disease in real-use conditions, particularly the antithrombotic agents for stroke prevention. The aim of this work is to present the study protocol of phase I of the ESC-FA study and the baseline characteristics of newly diagnosed patients with atrial fibrillation in Catalonia, Spain. Participants The data source is System for the Improvement of Research in Primary Care (SIDIAP) database. The population included are all patients with non-valvular atrial fibrillation diagnosis registered in the electronic health records during 2007–2012. Findings to date A total of 22 585 patients with non-valvular atrial fibrillation were included in the baseline description. Their mean age was 72.8 years and 51.6% were men. The most commonly prescribed antithrombotics were vitamin K antagonists (40.1% of patients) and platelet aggregation inhibitors (32.9%); 25.3% had not been prescribed antithrombotic treatment. Age, gender, comorbidities and co-medication at baseline were similar to those reported for previous studies. Future plans The next phase in the ESC-FA study will involve assessing the effectiveness and safety of antithrombotic treatments, analysing stroke events and bleeding episodes’ rates in our patients (rest of phase I), describing the current management of the disease and its costs in our setting, and assessing how the introduction of new oral anticoagulants changes the stroke prevention in non-valvular atrial fibrillation. PMID:26823179

  11. Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) study: Methodology and baseline characteristics of a randomized controlled trial evaluating an occupation-based diabetes management intervention for young adults.

    PubMed

    Pyatak, Elizabeth A; Carandang, Kristine; Vigen, Cheryl; Blanchard, Jeanine; Sequeira, Paola A; Wood, Jamie R; Spruijt-Metz, Donna; Whittemore, Robin; Peters, Anne L

    2017-03-01

    This paper describes the study protocol used to evaluate the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) intervention and reports on baseline characteristics of recruited participants. REAL Diabetes is an activity-based intervention designed to address the needs of young adults diagnosed with type 1 (T1D) or type 2 diabetes (T2D) from low socioeconomic status or racial/ethnic minority backgrounds. The REAL intervention incorporates tailored delivery of seven content modules addressing various dimensions of health and well-being as they relate to diabetes, delivered by a licensed occupational therapist. In this pilot randomized controlled trial, participants are assigned to the REAL Diabetes intervention or an attention control condition. The study's primary recruitment strategies included in-person recruitment at diabetes clinics, mass mailings to clinic patients, and social media advertising. Data collection includes baseline and 6-month assessments of primary outcomes, secondary outcomes, and hypothesized mediators of intervention effects, as well as ongoing process evaluation assessment to ensure study protocol adherence and intervention fidelity. At baseline, participants (n=81) were 51% female, 78% Latino, and on average 22.6years old with an average HbA1c of 10.8%. A majority of participants (61.7%) demonstrated clinically significant diabetes distress and 27.2% reported symptoms consistent with major depressive disorder. Compared to participants with T1D, participants with T2D had lower diabetes-related self-efficacy and problem-solving skills. Compared to participants recruited at clinics, participants recruited through other strategies had greater diabetes knowledge but weaker medication adherence. Participants in the REAL study demonstrate clinically significant medical and psychosocial needs. Copyright © 2017 Elsevier Inc. All rights reserved.

  12. Design, methodology and baseline characteristics of Tai Chi and its protective effect against ischaemic stroke risk in an elderly community population with risk factors for ischaemic stroke: a randomised controlled trial

    PubMed Central

    Zheng, Guohua; Zheng, Xin; Li, Junzhe; Duan, Tingjin; Qi, Dalu; Ling, Kun; He, Jian; Chen, Lidian

    2015-01-01

    Introduction Controlling risk factors with regular exercise is effective and cost-effective for the primary prevention of ischaemic stroke. As a traditional Chinese form of exercise, Tai Chi might be beneficial in decreasing ischaemic stroke, but the evidence remains insufficient. We hypothesise that elderly community adults with risk factors for ischaemic stroke will decrease their ischaemic stroke risk by improving cerebral haemodynamic parameters, cardiopulmonary function, motor function, plasma risk indices, physical parameters or psychological outcomes after receiving 12 weeks of regular Tai Chi training compared with those who maintained their original physical activities. Therefore, we designed a randomised controlled trial that will systematically evaluate the protective effects of Tai Chi exercise on ischaemic stroke risk in an elderly community population with risk factors for ischaemic stroke. Methods and analysis A total of 170 eligible participants were randomly allocated into either the Tai Chi training group or the usual physical activity group. This paper reports on the design, intervention development and baseline characteristics of the participants. There were no significant differences between comparison groups in demographic characteristics or the baseline data of primary or secondary outcomes. Participants in the Tai Chi training group will receive 12 weeks of Tai Chi training with a frequency of 5 days/week and 60 min/day, while those in the usual physical activities group will maintain their original activities. Primary and secondary outcomes will be measured at the 12-week and 24-week follow-ups. Ethics and dissemination Ethical approval has been obtained from the Medical Ethics Committee of The Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine (number 2013-020-02). The findings of this study will be communicated to healthcare professionals, participants and the public through peer

  13. Design, methodology and baseline characteristics of Tai Chi and its protective effect against ischaemic stroke risk in an elderly community population with risk factors for ischaemic stroke: a randomised controlled trial.

    PubMed

    Zheng, Guohua; Zheng, Xin; Li, Junzhe; Duan, Tingjin; Qi, Dalu; Ling, Kun; He, Jian; Chen, Lidian

    2015-12-23

    Controlling risk factors with regular exercise is effective and cost-effective for the primary prevention of ischaemic stroke. As a traditional Chinese form of exercise, Tai Chi might be beneficial in decreasing ischaemic stroke, but the evidence remains insufficient. We hypothesise that elderly community adults with risk factors for ischaemic stroke will decrease their ischaemic stroke risk by improving cerebral haemodynamic parameters, cardiopulmonary function, motor function, plasma risk indices, physical parameters or psychological outcomes after receiving 12 weeks of regular Tai Chi training compared with those who maintained their original physical activities. Therefore, we designed a randomised controlled trial that will systematically evaluate the protective effects of Tai Chi exercise on ischaemic stroke risk in an elderly community population with risk factors for ischaemic stroke. A total of 170 eligible participants were randomly allocated into either the Tai Chi training group or the usual physical activity group. This paper reports on the design, intervention development and baseline characteristics of the participants. There were no significant differences between comparison groups in demographic characteristics or the baseline data of primary or secondary outcomes. Participants in the Tai Chi training group will receive 12 weeks of Tai Chi training with a frequency of 5 days/week and 60 min/day, while those in the usual physical activities group will maintain their original activities. Primary and secondary outcomes will be measured at the 12-week and 24-week follow-ups. Ethical approval has been obtained from the Medical Ethics Committee of The Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine (number 2013-020-02). The findings of this study will be communicated to healthcare professionals, participants and the public through peer-reviewed publications or scientific conferences. ChiCTR-TRC-13003601; Pre

  14. Baseline characteristics in the Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial.

    PubMed

    Lambers Heerspink, Hiddo J; Chertow, Glenn M; Akizawa, Tadao; Audhya, Paul; Bakris, George L; Goldsberry, Angie; Krauth, Melissa; Linde, Peter; McMurray, John J; Meyer, Colin J; Parving, Hans-Henrik; Remuzzi, Giuseppe; Christ-Schmidt, Heidi; Toto, Robert D; Vaziri, Nosratola D; Wanner, Christoph; Wittes, Janet; Wrolstad, Danielle; de Zeeuw, Dick

    2013-11-01

    Type 2 diabetes mellitus (T2DM) is the most important contributing cause of end-stage renal disease (ESRD) worldwide. Bardoxolone methyl, a nuclear factor-erythroid-2-related factor 2 activator, augments estimated glomerular filtration. The Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial was designed to establish whether bardoxolone methyl slows or prevents progression to ESRD. Herein, we describe baseline characteristics of the BEACON population. BEACON is a randomized double-blind placebo-controlled clinical trial in 2185 patients with T2DM and chronic kidney disease stage 4 (eGFR between 15 and 30 mL/min/1.73 m(2)) designed to test the hypothesis that bardoxolone methyl added to guideline-recommended treatment including inhibitors of the renin-angiotensin-aldosterone system slows or prevents progression to ESRD or cardiovascular death compared with placebo. Baseline characteristics (mean or percentage) of the population include age 68.5 years, female 43%, Caucasian 78%, eGFR 22.5 mL/min/1.73 m(2) and systolic/diastolic blood pressure 140/70 mmHg. The median urinary albumin:creatinine ratio was 320 mg/g and the frequency of micro- and macroalbuminuria was 30 and 51%, respectively. Anemia, abnormalities in markers of bone metabolism and elevations in cardiovascular biomarkers were frequently observed. A history of cardiovascular disease was present in 56%, neuropathy in 47% and retinopathy in 41% of patients. The BEACON trial enrolled a population heretofore unstudied in an international randomized controlled trial. Enrolled patients suffered with numerous co-morbid conditions and exhibited multiple laboratory abnormalities, highlighting the critical need for new therapies to optimize management of these conditions.

  15. Baseline Characteristics of Jordan Creek, Juneau, Alaska

    USGS Publications Warehouse

    Host, Randy H.; Neal, Edward G.

    2004-01-01

    Anadromous fish populations historically have found healthy habitat in Jordan Creek, Juneau, Alaska. Concern regarding potential degradation to the habitat by urban development within the Mendenhall Valley led to a cooperative study among the City and Borough of Juneau, Alaska Department of Environmental Conservation, and the U.S. Geological Survey, that assessed current hydrologic, water-quality, and physical-habitat conditions of the stream corridor. Periods of no streamflow were not uncommon at the Jordan Creek below Egan Drive near Auke Bay stream gaging station. Additional flow measurements indicate that periods of no flow are more frequent downstream of the gaging station. Although periods of no flow typically were in March and April, streamflow measurements collected prior to 1999 indicate similar periods in January, suggesting that no flow conditions may occur at any time during the winter months. This dewatering in the lower reaches likely limits fish rearing and spawning habitat as well as limiting the migration of juvenile salmon out to the ocean during some years. Dissolved-oxygen concentrations may not be suitable for fish survival during some winter periods in the Jordan Creek watershed. Dissolved-oxygen concentrations were measured as low as 2.8 mg/L at the gaging station and were measured as low as 0.85 mg/L in a tributary to Jordan Creek. Intermittent measurements of pH and dissolved-oxygen concentrations in the mid-reaches of Jordan Creek were all within acceptable limits for fish survival, however, few measurements of these parameters were made during winter-low-flow conditions. One set of water quality samples was collected at six different sites in the Jordan Creek watershed and analyzed for major ions and dissolved nutrients. Major-ion chemistry showed Jordan Creek is calcium bicarbonate type water with little variation between sampling sites.

  16. Internalisation and multiple phosphorylation of γ-Conglutin, the lupin seed glycaemia-lowering protein, in HepG2 cells

    SciTech Connect

    Capraro, Jessica; Magni, Chiara; Faoro, Franco; Maffi, Dario; Scarafoni, Alessio; Tedeschi, Gabriella; Maffioli, Elisa; Parolari, Anna; Manzoni, Cristina; Lovati, Maria Rosa; Duranti, Marcello

    2013-08-09

    Highlights: •A glycaemia-reducing lupin seed protein is internalized by HepG2 cells. •The protein accumulates in the cytosol in an intact form. •The internalized protein is multiply phosphorylated. -- Abstract: Lupin seed γ-Conglutin is a protein capable of reducing glycaemia in mammalians and increasing glucose uptake by model cells. This work investigated whether γ-Conglutin is internalised into the target cells and undergoes any covalent change during the process, as a first step to understanding its mechanism of action. To this purpose, γ-Conglutin-treated and untreated HepG2 cells were submitted to confocal and transmission electron microscopy. Immune-revelation of γ-Conglutin at various intervals revealed its accumulation inside the cytosol. In parallel, 2D-electrophoresis of the cell lysates and antibody reaction of the blotted maps showed the presence of the protein intact subunits inside the treated cells, whilest no trace of the protein was found in the control cells. However, γ-Conglutin-related spots with an unexpectedly low pI were also observed in the maps. These spots were excised, trypsin-treated and submitted to MS/MS spectrometric analysis. The presence of phosphorylated amino acids was detected. These findings, by showing that γ-Conglutin is internalised by HepG2 cells in an intact form and is modified by multiple phosphorylation, open the way to the understanding of the lupin γ-Conglutin insulin-mimetic activity.

  17. Instant coffee extract with high chlorogenic acids content inhibits hepatic G-6-Pase in vitro, but does not reduce the glycaemia.

    PubMed

    Bassoli, Bruna Kempfer; Cassolla, Priscila; Borba-Murad, Glaucia Regina; Constantin, Jorgete; Salgueiro-Pagadigorria, Clairce Luzia; Bazotte, Roberto Barbosa; de Souza, Helenir Medri

    2015-06-01

    Coffee is the main source of chlorogenic acid in the human diet, and it contains several chlorogenic acid isomers, of which the 5-caffeoylquinic acid (5-CQA) is the predominant isomer. Because there are no available data about the action of chlorogenic acids from instant coffee on hepatic glucose-6-phosphatase (G-6-Pase) activity and blood glucose levels, these effects were investigated in rats. The changes on G-6-Pase activity and liver glucose output induced by 5-CQA were also investigated. Instant coffee extract with high chlorogenic acids content (37.8%) inhibited (p < 0.05) the G-6-Pase activity of the hepatocyte microsomal fraction in a dose-dependent way (up to 53), but IV administration of this extract did not change the glycaemia (p > 0.05). Similarly, 5-CQA (1 mM) reduced (p < 0.05) the activity of microsomal G-6-Pase by about 40%, but had no effect (p > 0.05) on glucose output arising from glycogenolysis in liver perfusion. It was concluded that instant coffee extract with high content of chlorogenic acids inhibited hepatic G-6-Pase in vitro, but failed to reduce the glycaemia probably because the coffee chlorogenic acids did not reach enough levels within the hepatocytes to inhibit the G-6-Pase and reduce the liver glucose output. Copyright © 2015 John Wiley & Sons, Ltd.

  18. Optical Long Baseline Interferometry

    NASA Astrophysics Data System (ADS)

    Le Bouquin, Jean-Baptiste

    Optical Long Baseline Interferometry provides unrivalled angular resolution on bright and compact astrophysical sources. The link between the observables (interferometric phase and contrast) and the image of the source is a Fourier transform expressed first by van Cittert and Zernike. Depending on the source size and the amount of information collected, the analysis of these Fourier components allows a measurement of the typical source size, a parametric modelling of its spatial structures, or a model-independent image reconstruction to be carried. In the past decades, optical long baseline interferometry provided fundamental measurements for astronomy (ex. Cepheids distances, surface-brightness relations) as well as iconic results such as the first images of stellar surfaces other than the Sun. Optical long baseline interferometers exist in the Northern and Southern hemisphere and are open to the astronomical community with modern level of support. We provide in this chapter an introduction to the fundamental principles of optical interferometry and introduce the currently available facilities.

  19. West Virginia baseline

    NASA Astrophysics Data System (ADS)

    Cardi, V. P.; Baer, C.; Graham, A.; Hall, T.; Rankin, D.; Sweet, T. J.

    1981-04-01

    Baseline information on West Virginia is provided. The topics covered are terrestrial ecology, aquatic ecology, geology and climatology, socioeconomics, and a legal analysis of institutional accountability. The hydrology, water quality, endangered species, and clean streams of five river basins are described.

  20. First Grade Baseline Evaluation

    ERIC Educational Resources Information Center

    Center for Innovation in Assessment (NJ1), 2013

    2013-01-01

    The First Grade Baseline Evaluation is an optional tool that can be used at the beginning of the school year to help teachers get to know the reading and language skills of each student. The evaluation is composed of seven screenings. Teachers may use the entire evaluation or choose to use those individual screenings that they find most beneficial…

  1. Rationale, design and baseline characteristics of a large, simple, randomized trial of combined folic acid and vitamins B6 and B12 in high-risk patients: The Heart Outcomes Prevention Evaluation (HOPE)-2 trial

    PubMed Central

    2006-01-01

    BACKGROUND Epidemiological studies suggest that mild to moderate elevation in plasma homocysteine concentration is associated with increased risk of atherothrombotic cardiovascular (CV) disease. Simple, inexpensive and nontoxic therapy with folic acid and vitamins B6 and B12 reduces plasma homocysteine levels by approximately 25% to 30% and may reduce CV events. Therefore, a large, randomized clinical trial – the Heart Outcomes Prevention Evaluation (HOPE)-2 study – is being conducted to evaluate this therapy in patients at high risk for CV events. OBJECTIVES To evaluate whether long-term therapy with folic acid and vitamins B6 and B12 reduces the risk of major CV events in a high-risk population. The primary study outcome is the composite of death from CV causes, myocardial infarction and stroke. METHODS A total of 5522 patients aged 55 years or older with pre-existing CV disease or with diabetes and additional risk factor(s) at 145 centres in 13 countries were randomly assigned to daily therapy with combined folic acid 2.5 mg, vitamin B6 50 mg and vitamin B12 1 mg, or to placebo. Follow-up will average five years, to be completed by the end of 2005. RESULTS The patients’ baseline characteristics confirmed their high-risk status. Baseline homocysteine levels varied between countries and regions. HOPE-2 is one of the largest trials of folate and vitamins B6 and B12 and is expected to significantly contribute to the evaluation of the role of homocysteine lowering in CV prevention. PMID:16450017

  2. Regional differences in presentation and antithrombotic treatment of patients with atrial fibrillation: Baseline characteristics from a clustered randomized trial to IMProve treatment with AntiCoagulanTs in patients with atrial fibrillation (IMPACT-AF).

    PubMed

    Vinereanu, Dragos; Al-Khalidi, Hussein R; Rao, Meena P; He, Wensheng; Lopes, Renato D; Bahit, Cecilia M; Ciobanu, Andrea O; Fox, Kathleen A; Pokorney, Sean D; Xian, Ying; Jiang, Jie; Kamath, Deepak Y; Berwanger, Otavio; Tajer, Carlos; Huo, Yong; Xavier, Denis; Granger, Christopher B

    2017-10-01

    Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide. However, there are few contemporary comparative data on AF from middle-income countries. Baseline characteristics of the IMPACT-AF trial were analyzed to assess regional differences in presentation and antithrombotic treatment of AF from 5 middle-income countries (Argentina, Brazil, China, India, and Romania) and factors associated with antithrombotic treatment prescription. IMPACT-AF enrolled 2281 patients (69 ± 11 years, 47% women) at 48 sites. Overall, 66% of patients were on anticoagulation at baseline, ranging from 38% in China to 91% in Brazil. The top 3 reasons for not prescribing an anticoagulant were patient preference/refusal (26%); concomitant antiplatelet therapy (15%); and risks outweighing the benefits, as assessed by the physician (13%). In a multivariable model, the most significant factors associated with prescription of oral anticoagulants were no prior major bleeding (odds ratio [OR] = 4.34; 95% CI = 2.22-8.33), no alcohol abuse (OR = 2.27; 95% CI = 1.12-4.55), and history of rheumatic valvular heart disease (OR = 2.10; 95% CI = 1.36-3.26), with a strong predictive accuracy (c statistic = 0.85), whereas the most significant factors associated with prescription of a combination of oral anticoagulants and antiplatelet drugs were prior coronary revascularization (OR = 5.10; 95% CI = 2.88-9.05), prior myocardial infarction (OR = 2.24; 95% CI = 1.38-3.63), and no alcohol abuse (OR = 2.22; 95% CI = 1.11-4.55), with a good predictive accuracy (c statistic = 0.76). IMPACT-AF provides contemporary data from 5 middle-income countries regarding antithrombotic treatment of AF. Lack of prior major bleeding and coronary revascularization were the most important factors associated with prescription of oral anticoagulants and their combination with antiplatelet drugs, respectively. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. Subsets of symptomatic hand osteoarthritis in community-dwelling older adults in the United Kingdom: prevalence, inter-relationships, risk factor profiles and clinical characteristics at baseline and 3-years

    PubMed Central

    Marshall, M.; Peat, G.; Nicholls, E.; van der Windt, D.; Myers, H.; Dziedzic, K.

    2013-01-01

    Summary Objective To compare the population prevalence, inter-relationships, risk factor profiles and clinical characteristics of subsets of symptomatic hand osteoarthritis (OA) with a view to understanding their relative frequency and distinctiveness. Method 1076 community-dwelling adults with hand symptoms (60% women, mean age 64.7 years) were recruited and classified into pre-defined subsets using physical examination and standardised hand radiographs, scored with the Kellgren & Lawrence (K&L) and Verbruggen–Veys grading systems. Detailed information on selected risk factors was obtained from direct measurement (Body Mass Index (BMI)), self-complete questionnaires (excessive use of hands, previous hand injury) and medical record review (hypertension, dyslipidaemia, type 2 diabetes). Hand pain and disability were self-reported at baseline and 3-year follow-up using Australian/Canadian Osteoarthritis Hand Index (AUSCAN). Results Crude population prevalence estimates for symptomatic hand OA subsets in the adult population aged 50 years and over were: thumb base OA (22.4%), nodal interphalangeal joint (IPJ) OA (15.5%), generalised hand OA (10.4%), non-nodal IPJ OA (4.9%), erosive OA (1.0%). Apart from thumb base OA, there was considerable overlap between the subsets. Erosive OA appeared the most distinctive with the highest female: male ratio, and the most disability at baseline and 3-years. A higher frequency of obesity, hypertension, dyslipidaemia, and metabolic syndrome was observed in this subset. Conclusion Overlap in the occurrence of hand OA subsets poses conceptual and practical challenges to the pursuit of distinct phenotypes. Erosive OA may nevertheless provide particular insight into the role of metabolic and cardiovascular risk factors in the pathogenesis of OA. PMID:23954700

  4. Peer Support for Achieving Independence in Diabetes (Peer-AID): design, methods and baseline characteristics of a randomized controlled trial of community health worker assisted diabetes self-management support.

    PubMed

    Nelson, Karin; Drain, Nathan; Robinson, June; Kapp, Janet; Hebert, Paul; Taylor, Leslie; Silverman, Julie; Kiefer, Meghan; Lessler, Dan; Krieger, James

    2014-07-01

    Community health workers (CHWs) may be an important mechanism to provide diabetes self-management to disadvantaged populations. We describe the design and baseline results of a trial evaluating a home-based CHW intervention. Peer Support for Achieving Independence in Diabetes (Peer-AID) is a randomized, controlled trial evaluating a home-based CHW-delivered diabetes self-management intervention versus usual care. The study recruited participants from 3 health systems. Change in A1c measured at 12 months is the primary outcome. Changes in blood pressure, lipids, health care utilization, health-related quality of life, self-efficacy and diabetes self-management behaviors at 12 months are secondary outcomes. A total of 1438 patients were identified by a medical record review as potentially eligible, 445 patients were screened by telephone for eligibility and 287 were randomized. Groups were comparable at baseline on socio-demographic and clinical characteristics. All participants were low-income and were from diverse racial and ethnic backgrounds. The mean A1c was 8.9%, mean BMI was above the obese range, and non-adherence to diabetes medications was high. The cohort had high rates of co-morbid disease and low self-reported health status. Although one-third reported no health insurance, the mean number of visits to a physician in the past year was 5.7. Trial results are pending. Peer-AID recruited and enrolled a diverse group of low income participants with poorly controlled type 2 diabetes and delivered a home-based diabetes self-management program. If effective, replication of the Peer-AID intervention in community based settings could contribute to improved control of diabetes in vulnerable populations. Published by Elsevier Inc.

  5. STAR 3 Randomized Controlled Trial to Compare Sensor-Augmented Insulin Pump Therapy with Multiple Daily Injections in the Treatment of Type 1 Diabetes: Research Design, Methods, and Baseline Characteristics of Enrolled Subjects

    PubMed Central

    Horton, Edward S.; Battelino, Tadej; Rubin, Richard R.; Schulman, Kevin A.; Tamborlane, William V.

    2010-01-01

    Abstract Background Sensor-augmented pump therapy (SAPT) integrates real-time continuous glucose monitoring (RT-CGM) with continuous subcutaneous insulin infusion (CSII) and offers an alternative to multiple daily injections (MDI). Previous studies provide evidence that SAPT may improve clinical outcomes among people with type 1 diabetes. Sensor-Augmented Pump Therapy for A1c Reduction (STAR) 3 is a multicenter randomized controlled trial comparing the efficacy of SAPT to that of MDI in subjects with type 1 diabetes. Methods Subjects were randomized to either continue with MDI or transition to SAPT for 1 year. Subjects in the MDI cohort were allowed to transition to SAPT for 6 months after completion of the study. SAPT subjects who completed the study were also allowed to continue for 6 months. The primary end point was the difference between treatment groups in change in hemoglobin A1c (HbA1c) percentage from baseline to 1 year of treatment. Secondary end points included percentage of subjects with HbA1c ≤7% and without severe hypoglycemia, as well as area under the curve of time spent in normal glycemic ranges. Tertiary end points include percentage of subjects with HbA1c ≤7%, key safety end points, user satisfaction, and responses on standardized assessments. Results A total of 495 subjects were enrolled, and the baseline characteristics similar between the SAPT and MDI groups. Study completion is anticipated in June 2010. Conclusions Results of this randomized controlled trial should help establish whether an integrated RT-CGM and CSII system benefits patients with type 1 diabetes more than MDI. PMID:20210562

  6. Comparison of baseline characteristics and clinical course in Japanese patients with type 2 diabetes among whom different types of oral hypoglycemic agents were chosen by diabetes specialists as initial monotherapy (JDDM 42)

    PubMed Central

    Fujihara, Kazuya; Igarashi, Risa; Matsunaga, Satoshi; Matsubayashi, Yasuhiro; Yamada, Takaho; Yokoyama, Hiroki; Tanaka, Shiro; Shimano, Hitoshi; Maegawa, Hiroshi; Yamazaki, Katsuya; Kawai, Koichi; Sone, Hirohito

    2017-01-01

    Abstract Little is known about the relationships between patient factors and the antihyperglycemic agents that have been prescribed as initial therapy by diabetes specialists for patients with type 2 diabetes. Moreover, there has been little clarification of the subsequent usage patterns and related factors that influenced the continuation or discontinuation of the drug or the addition of another drug. To provide information on these issues, we evaluated the clinical characteristics of Japanese patients with type 2 diabetes for whom different types of oral hypoglycemic agents (i.e., either sulfonylureas, biguanides, or DPP-4 inhibitors (DPP-4Is)) were chosen as initial monotherapy by diabetes specialists and evaluated subsequent usage patterns. Prescription data on 3 different antidiabetic agents from December 2009 to March 2015 from diabetes specialists’ patient registries were used to identify variables at baseline related to initial prescriptions; also, the addition of another hypoglycemic drug or discontinuation of the initial therapy was evaluated 1 year after the initial prescription. Analyzed were data on 2666 patients who received initial monotherapy with either a sulfonylurea (305 patients), biguanide (951 patients), or DPP-4I (1410 patients). Patients administered sulfonylureas were older, had a lower body mass index (BMI), longer duration of diabetes, and worse glycemic control than recipients of biguanides. Use of biguanides was related to younger age, short duration of diabetes, and obesity but was negatively associated with poor glycemic control. Older age but neither obesity nor poor glycemic control was associated with DPP-4Is. In all 3 groups a high HbA1c value was related to adding another hypoglycemic agent to the initial therapy. Moreover, adding another drug to a DPP-4I was related to a younger age and higher BMI. Patients’ age, duration of diabetes, obesity, and glycemic control at baseline influenced the choice of hypoglycemic agents

  7. Bipolar II compared with bipolar I disorder: baseline characteristics and treatment response to quetiapine in a pooled analysis of five placebo-controlled clinical trials of acute bipolar depression.

    PubMed

    Datto, Catherine; Pottorf, William J; Feeley, Louisa; LaPorte, Scott; Liss, Charlie

    2016-01-01

    Bipolar I and II represent the most common and severe subtypes of bipolar disorder. Although bipolar I disorder is relatively well studied, the clinical characteristics and response to treatment of patients with bipolar II disorder are less well understood. To compare the severity and burden of illness of patients with bipolar II versus bipolar I disorder, baseline demographic, clinical, and quality of life data were examined in 1900 patients with bipolar I and 973 patients with bipolar II depression, who were enrolled in five similarly designed clinical placebo-controlled trials of quetiapine immediate-release and quetiapine extended-release. Acute (8 weeks) response to treatment was also compared by assessing rating scale scores, including Montgomery-Åsberg depression rating scale, Hamilton rating scale for anxiety, Young mania rating scale, and clinical global impression-severity scores, in the bipolar I and II populations in the same pooled database. Patients with bipolar I and bipolar II depression were similar in demographics, baseline rating scale scores (depression, anxiety, mania, and quality of life), and mood episode histories. Symptom improvements in response to quetiapine were greater versus comparators (lithium, paroxetine, and placebo) at 4 and 8 weeks in both bipolar I and II patients. Patients with the bipolar II subtype initially showed slower responses to all treatments, but, by 8 weeks, attained similar symptom improvement as patients with bipolar I depression. Pooled analysis of five clinical trials of quetiapine demonstrated that patients with bipolar II depression have a similar burden of illness and quality of life to patients with bipolar I. Bipolar II patients consistently showed a slower response to treatments than bipolar I patients, but, after 8 weeks of treatment with quetiapine, symptom improvements were similar between bipolar I and II disorder subtypes.

  8. Design and baseline characteristics of participants in the TRial of Economic Incentives to Promote Physical Activity (TRIPPA): a randomized controlled trial of a six month pedometer program with financial incentives.

    PubMed

    Finkelstein, Eric A; Sahasranaman, Aarti; John, Geraldine; Haaland, Benjamin A; Bilger, Marcel; Sloan, Robert A; Nang, Ei Ei Khaing; Evenson, Kelly R

    2015-03-01

    Non-communicable diseases (NCDs) are emerging as the predominant global health challenge of this century. Physical inactivity is one of the primary risk factors for NCDs. Therefore, increasing physical activity levels is a public health imperative. The arrival of affordable wearable technologies, such as wireless pedometers, provides one strategy for encouraging walking. However, the effectiveness of these technologies in promoting sustained behavior change has not been established. Insights from economics suggest that incentives may be a useful strategy for increasing maintenance and effectiveness of behavior change interventions, including physical activity interventions that rely on wearable technologies. The aim of this trial is to test the effectiveness of a common wireless pedometer with or without one of two types of incentives (cash or donations to charity) for reaching weekly physical activity goals. We present here the design and baseline characteristics of participants of this four arm randomized controlled trial. 800 full-time employees (desk-bound office workers) belonging to 15 different worksites (on average, 53 (sd: 37) employees at each worksite) were successfully randomized to one of four study arms. If shown to be effective, wearable technologies in concert with financial incentives may provide a scalable and affordable health promotion strategy for governments and employers seeking to increase the physical activity levels of their constituents. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. Baseline assessment of physical characteristics, aquatic biota, and selected water-quality properties at the reach and mesohabitat scale for three stream reaches in the Big Cypress Basin, northeastern Texas, 2010-11

    USGS Publications Warehouse

    Braun, Christopher L.; Moring, James B.

    2013-01-01

    The U.S. Geological Survey (USGS), in cooperation with the Northeast Texas Municipal Water District and the Texas Commission on Environmental Quality, did a baseline assessment in 2010-11 of physical characteristics and selected aquatic biota (fish and mussels) collected at the mesohabitat scale for three stream reaches in the Big Cypress Basin in northeastern Texas for which environmental flows have been prescribed. Mesohabitats are visually distinct units of habitat within the stream with unique depth, velocity, slope, substrate, and cover. Mesohabitats in reaches of Big Cypress, Black Cypress, and Little Cypress Bayous were evaluated to gain an understanding of how fish communities and mussel populations varied by habitat. Selected water-quality properties were also measured in isolated pools in Black Cypress and Little Cypress. All of the data were collected in the context of the prescribed environmental flows. The information acquired during the study will support the long-term monitoring of biota in relation to the prescribed environmental flows.

  10. Lower cardiorespiratory fitness contributes to increased insulin resistance and fasting glycaemia in middle-aged South Asian compared with European men living in the UK.

    PubMed

    Ghouri, N; Purves, D; McConnachie, A; Wilson, J; Gill, J M R; Sattar, N

    2013-10-01

    This study aimed to determine the extent to which increased insulin resistance and fasting glycaemia in South Asian men, compared with white European men, living in the UK, was due to lower cardiorespiratory fitness (maximal oxygen uptake [VO(2max)]) and physical activity. One hundred South Asian and 100 age- and BMI-matched European men without diagnosed diabetes, aged 40-70 years, had fasted blood taken for measurement of glucose concentration, HOMA-estimated insulin resistance (HOMA(IR)), plus other risk factors, and underwent assessment of physical activity (using accelerometry), VO(2max), body size and composition, and demographic and other lifestyle factors. For 13 South Asian and one European man, HbA1c levels were >6.5% (>48 mmol/mol), indicating potential undiagnosed diabetes; these men were excluded from the analyses. Linear regression models were used to determine the extent to which body size and composition, fitness and physical activity variables explained differences in HOMA(IR) and fasting glucose between South Asian and European men. HOMA(IR) and fasting glucose were 67% (p < 0.001) and 3% (p < 0.018) higher, respectively, in South Asians than Europeans. Lower VO(2max), lower physical activity and greater total adiposity in South Asians individually explained 68% (95% CI 45%, 91%), 29% (11%, 46%) and 52% (30%, 80%), respectively, and together explained 83% (50%, 119%) (all p < 0.001) of the ethnic difference in HOMA(IR). Lower VO(2max) and greater total adiposity, respectively, explained 61% (9%, 111%) and 39% (9%, 76%) (combined effect 63% [8%, 115%]; all p < 0.05) of the ethnic difference in fasting glucose. Lower cardiorespiratory fitness is a key factor associated with the excess insulin resistance and fasting glycaemia in middle-aged South Asian, compared with European, men living in the UK.

  11. FED baseline engineering studies report

    SciTech Connect

    Sager, P.H.

    1983-04-01

    Studies were carried out on the FED Baseline to improve design definition, establish feasibility, and reduce cost. Emphasis was placed on cost reduction, but significant feasibility concerns existed in several areas, and better design definition was required to establish feasibility and provide a better basis for cost estimates. Design definition and feasibility studies included the development of a labyrinth shield ring concept to prevent radiation streaming between the torus spool and the TF coil cryostat. The labyrinth shield concept which was developed reduced radiation streaming sufficiently to permit contact maintenance of the inboard EF coils. Various concepts of preventing arcing between adjacent shield sectors were also explored. It was concluded that installation of copper straps with molybdenum thermal radiation shields would provide the most reliable means of preventing arcing. Other design studies included torus spool electrical/structural concepts, test module shielding, torus seismic response, poloidal conditions in the magnets, disruption characteristics, and eddy current effects. These additional studies had no significant impact on cost but did confirm the feasibility of the basic FED Baseline concept.

  12. The PICASSO Cohort: baseline characteristics of a cohort of men who have sex with men and male-to-female transgender women at high risk for syphilis infection in Lima, Peru.

    PubMed

    Kojima, Noah; Park, Hayoung; Konda, Kelika A; Joseph Davey, Dvora L; Bristow, Claire C; Brown, Brandon; Leon, Segundo R; Vargas, Silver K; Calvo, Gino M; Caceres, Carlos F; Klausner, Jeffrey D

    2017-04-11

    Men who have sex with men (MSM) and male-to-female transgender women (transwomen) are disproportionately at risk of syphilis infection in Peru. From 2013 to 2014, MSM and transwomen seeking human immunodeficiency virus (HIV) or sexually transmitted infection (STI) testing and/or treatment were recruited into a 2-year observational cohort study to determine predictors of recently acquired syphilis infection (defined as a rapid plasma reagin [RPR] titer ≥1:16 and a reactive treponemal antibody test) in Lima, Peru. At baseline, interviewers collected sociodemographic, behavioral, and medical characteristics from participants. All cohort participants were tested for syphilis, HIV, Chlamydia trachomatis (CT), and Neisseria gonorrhoeae (NG) infection. Using cross-sectional analyses, bivariate and multivariate models were used to determine factors associated with recently acquired syphilis infection and calculate adjusted prevalence ratios. We recruited 401 participants, 312 MSM and 89 transwomen, with median ages of 29.0 and 32.5 years old (interquartile ranges: 23.3, 37.4 and 27.2, 39.5, respectively). The prevalence of recently acquired syphilis infection at baseline was 16.8% for MSM and 6.7% for transwomen. Among MSM and transwomen, 30.1 and 33.7% were infected with HIV, 18.6 and 24.7% were infected with CT, and 14.2 and 19.1% were infected with NG, respectively. Co-infection rates among MSM with recently acquired syphilis infection included: 44.2% with HIV, 40.4% with CT (32.7% with anal CT and 7.7% with pharyngeal CT), and 19.2% with NG (11.5% with anal NG and 7.7% with pharyngeal NG). Co-infection rates among transwomen with recently acquired syphilis infection included: 66.7% with HIV, 0% with CT, and 16.7% with anal NG. In multivariate analysis among the entire cohort, recently acquired syphilis infection was independently associated with younger age (adjusted prevalence ratio [aPR] = 0.96, 95% confidence interval [CI] = 0.93-0.99), receptive role

  13. Design, methods, and baseline characteristics of the Kids' Health Insurance by Educating Lots of Parents (Kids' HELP) trial: a randomized, controlled trial of the effectiveness of parent mentors in insuring uninsured minority children.

    PubMed

    Flores, Glenn; Walker, Candy; Lin, Hua; Lee, Michael; Fierro, Marco; Henry, Monica; Massey, Kenneth; Portillo, Alberto

    2015-01-01

    Six million US children have no health insurance, and substantial racial/ethnic disparities exist. The design, methods, and baseline characteristics are described for Kids' Health Insurance by Educating Lots of Parents (Kids' HELP), the first randomized, clinical trial of the effectiveness of Parent Mentors (PMs) in insuring uninsured minority children. Latino and African-American children eligible for but not enrolled in Medicaid/CHIP were randomized to PMs, or a control group receiving traditional Medicaid/CHIP outreach. PMs are experienced parents with ≥1 Medicaid/CHIP-covered children. PMs received two days of training, and provide intervention families with information on Medicaid/CHIP eligibility, assistance with application submission, and help maintaining coverage. Primary outcomes include obtaining health insurance, time interval to obtain coverage, and parental satisfaction. A blinded assessor contacts subjects monthly for one year to monitor outcomes. Of 49,361 candidates screened, 329 fulfilled eligibility criteria and were randomized. The mean age is seven years for children and 32 years for caregivers; 2/3 are Latino, 1/3 are African-American, and the mean annual family income is $21,857. Half of caregivers were unaware that their uninsured child is Medicaid/CHIP eligible, and 95% of uninsured children had prior insurance. Fifteen PMs completed two-day training sessions. All PMs are female and minority, 60% are unemployed, and the mean annual family income is $20,913. Post-PM-training, overall knowledge/skills test scores significantly increased, and 100% reported being very satisfied/satisfied with the training. Kids' HELP successfully reached target populations, met participant enrollment goals, and recruited and trained PMs. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Differences in Baseline Characteristics and Outcomes at One-and Two-Year Follow-up of Cancer Survivors Accrued via Self-Referral versus Cancer Registry in the FRESH START Diet and Exercise Trial

    PubMed Central

    Snyder, Denise Clutter; Sloane, Richard; Lobach, David; Lipkus, Isaac M.; Peterson, Bercedis; Kraus, William; Demark-Wahnefried, Wendy

    2013-01-01

    Participant accrual to research studies is a challenge, and oftentimes advertisements are used to supplement cases ascertained through clinic caseloads and cancer registries. It is unknown however, if cases ascertained through these two sources differ. In this study, we compare self-referred (n=209) versus cancer registry-ascertained participants (n=334) enrolled in FRESH START, a randomized controlled trial promoting a healthy diet and increased exercise among breast and prostate cancer survivors. The two groups were compared on baseline characteristics, adherence, attrition, and outcomes by study arm. Compared to participants enrolled from registries, self-referrals were significantly younger (54.1±10.4 vs. 58.7±10.7 years), more likely to have later-staged disease and to have received chemotherapy (40% vs. 19%), and more likely to report “fighting spirit” coping styles (50% vs. 30%), lower quality-of-life (88.2+15.1 vs. 92.0+12.9), fewer co-morbid conditions (1.87±1.60 vs. 2.24±1.78), and lower consumption of 5 or more daily servings of fruits and vegetables (35% vs. 45%)(p-values <.05). While no differences in behavior change were observed between self-referred and registry-ascertained cases assigned to the tailored intervention arm, this was not the case within the attention control arm. Among those who received the attention control intervention of standardized materials in the public domain, self-referred versus registry-ascertained participants demonstrated significantly greater increases in exercise at 1-year follow-up, and significantly greater increases in fruit and vegetable consumption at both 1- and 2-year follow-up (p-values <.05). Several differences exist between self-referred versus registry-ascertained participants, including motivation to respond to standardized educational materials which appears significantly greater in self-referred populations. PMID:18483353

  15. Design, methods, and baseline characteristics of the Kids’ Health Insurance by Educating Lots of Parents (Kids’ HELP) trial: A randomized, controlled trial of the effectiveness of parent mentors in insuring uninsured minority children✰

    PubMed Central

    Flores, Glenn; Walker, Candy; Lin, Hua; Lee, Michael; Fierro, Marco; Henry, Monica; Massey, Kenneth; Portillo, Alberto

    2014-01-01

    Background & objectives Six million US children have no health insurance, and substantial racial/ethnic disparities exist. The design, methods, and baseline characteristics are described for Kids’ Health Insurance by Educating Lots of Parents (Kids’ HELP), the first randomized, clinical trial of the effectiveness of Parent Mentors (PMs) in insuring uninsured minority children. Methods & research design Latino and African-American children eligible for but not enrolled in Medicaid/CHIP were randomized to PMs, or a control group receiving traditional Medicaid/CHIP outreach. PMs are experienced parents with ≥ 1 Medicaid/CHIP-covered children. PMs received two days of training, and provide intervention families with information on Medicaid/CHIP eligibility, assistance with application submission, and help maintaining coverage. Primary outcomes include obtaining health insurance, time interval to obtain coverage, and parental satisfaction. A blinded assessor contacts subjects monthly for one year to monitor outcomes. Results Of 49,361 candidates screened, 329 fulfilled eligibility criteria and were randomized. The mean age is seven years for children and 32 years for caregivers; 2/3 are Latino, 1/3 are African-American, and the mean annual family income is $21,857. Half of caregivers were unaware that their uninsured child is Medicaid/CHIP eligible, and 95% of uninsured children had prior insurance. Fifteen PMs completed two-day training sessions. All PMs are female and minority, 60% are unemployed, and the mean annual family income is $20,913. Post-PM-training, overall knowledge/skills test scores significantly increased, and 100% reported being very satisfied/satisfied with the training. Conclusions Kids’ HELP successfully reached target populations, met participant enrollment goals, and recruited and trained PMs. PMID:25476583

  16. Baseline Test Specimen Machining Report

    SciTech Connect

    mark Carroll

    2009-08-01

    The Next Generation Nuclear Plant (NGNP) Project is tasked with selecting a high temperature gas reactor technology that will be capable of generating electricity and supplying large amounts of process heat. The NGNP is presently being designed as a helium-cooled high temperature gas reactor (HTGR) with a large graphite core. The graphite baseline characterization project is conducting the research and development (R&D) activities deemed necessary to fully qualify nuclear-grade graphite for use in the NGNP reactor. Establishing nonirradiated thermomechanical and thermophysical properties by characterizing lot-to-lot and billet-to-billet variations (for probabilistic baseline data needs) through extensive data collection and statistical analysis is one of the major fundamental objectives of the project. The reactor core will be made up of stacks of graphite moderator blocks. In order to gain a more comprehensive understanding of the varying characteristics in a wide range of suitable graphites, any of which can be classified as “nuclear grade,” an experimental program has been initiated to develop an extensive database of the baseline characteristics of numerous candidate graphites. Various factors known to affect the properties of graphite will be investigated, including specimen size, spatial location within a graphite billet, specimen orientation within a billet (either parallel to [P] or transverse to [T] the long axis of the as-produced billet), and billet-to-billet variations within a lot or across different production lots. Because each data point is based on a certain position within a given billet of graphite, particular attention must be paid to the traceability of each specimen and its spatial location and orientation within each billet. The evaluation of these properties is discussed in the Graphite Technology Development Plan (Windes et. al, 2007). One of the key components in the evaluation of these graphite types will be mechanical testing on

  17. Is Glycaemia or Insulin Dose the Stronger Risk Factor for Coronory Artery Disease (CAD) in Type 1 Diabetes?

    PubMed Central

    Conway, Baqiyyah; Costacou, Tina; Orchard, Trevor

    2010-01-01

    Though Coronary Artery Disease (CAD) is the leading cause of death in Type 1 Diabetes (T1D), the mechanisms responsible for the greatly increased risk are poorly understood. In particular the role of glycaemic control is controversial with one study suggesting it predicts CAD mortality but not incidence. In this analysis, of the Pittsburgh Epidemiology of Diabetes Complications study cohort of T1D, we examine whether risk factors differ for CAD morbidity and mortality, with a specific focus on HbA1c and insulin dose. Participants (n=592) were followed for 18 years for incident non-fatal and fatal CAD. Cox stepwise regression was used to determine the independent risk factors for non-fatal and fatal CAD. Mean age and diabetes duration at study baseline were 29 and 20 years, respectively. There were 109 incident non-fatal and 48 fatal CAD events. Baseline HbA1c was an independent risk factor for fatal CAD, along with duration of diabetes and albuminuria. In contrast, baseline lower insulin dose was strongly predictive of non-fatal CAD, as was lower renal function, higher diastolic blood pressure, and lipids. HbA1c predicts CAD mortality while lower insulin dose and standard CAD risk factors predict CAD morbidity. PMID:20368215

  18. Long Baseline Neutrino Experiments

    NASA Astrophysics Data System (ADS)

    Mezzetto, Mauro

    2016-05-01

    Following the discovery of neutrino oscillations by the Super-Kamiokande collaboration, recently awarded with the Nobel Prize, two generations of long baseline experiments had been setup to further study neutrino oscillations. The first generation experiments, K2K in Japan, Minos in the States and Opera in Europe, focused in confirming the Super-Kamiokande result, improving the precision with which oscillation parameters had been measured and demonstrating the ντ appearance process. Second generation experiments, T2K in Japan and very recently NOνA in the States, went further, being optimized to look for genuine three neutrino phenomena like non-zero values of θ13 and first glimpses to leptonic CP violation (LCPV) and neutrino mass ordering (NMO). The discovery of leptonic CP violation will require third generation setups, at the moment two strong proposals are ongoing, Dune in the States and Hyper-Kamiokande in Japan. This review will focus a little more in these future initiatives.

  19. A baseline lunar mine

    NASA Technical Reports Server (NTRS)

    Gertsch, Richard E.

    1992-01-01

    A models lunar mining method is proposed that illustrates the problems to be expected in lunar mining and how they might be solved. While the method is quite feasible, it is, more importantly, a useful baseline system against which to test other, possible better, methods. Our study group proposed the slusher to stimulate discussion of how a lunar mining operation might be successfully accomplished. Critics of the slusher system were invited to propose better methods. The group noted that while nonterrestrial mining has been a vital part of past space manufacturing proposals, no one has proposed a lunar mining system in any real detail. The group considered it essential that the design of actual, workable, and specific lunar mining methods begin immediately. Based on an earlier proposal, the method is a three-drum slusher, also known as a cable-operated drag scraper. Its terrestrial application is quite limited, as it is relatively inefficient and inflexible. The method usually finds use in underwater mining from the shore and in moving small amounts of ore underground. When lunar mining scales up, the lunarized slusher will be replaced by more efficient, high-volume methods. Other aspects of lunar mining are discussed.

  20. A high-risk phenotype associates with reduced improvement in glycaemia during a lifestyle intervention in prediabetes.

    PubMed

    Stefan, Norbert; Staiger, Harald; Wagner, Robert; Machann, Jürgen; Schick, Fritz; Häring, Hans-Ulrich; Fritsche, Andreas

    2015-12-01

    Lack of reversal of prediabetes (impaired glucose tolerance and/or impaired fasting glucose) to normal glucose regulation (NGR) during a lifestyle intervention is strongly associated with a higher incidence of diabetes later in life. In the Tübingen Lifestyle Intervention Program (TULIP) we hypothesised that an at-risk phenotype may exist at baseline that associates with this nonresponse to the intervention. A total of 120 participants of TULIP with prediabetes at baseline were studied. Participants underwent 9 months of lifestyle intervention and had measurements of insulin secretion and insulin sensitivity during a 75 g OGTT, and measurements of liver fat content by proton magnetic resonance spectroscopy. During the lifestyle intervention, 55% of the participants did not revert to NGR. Even among participants with the largest body fat loss (upper quartile: -6.9 ± 3.3%, mean ± SD), 40% did not revert to NGR. In this regard, we identified at baseline a high-risk phenotype (n = 72) consisting of low disposition index or low insulin sensitivity + nonalcoholic fatty liver disease (NAFLD) and a low-risk phenotype (n = 48, all other traits). While the adjusted decrease in body fat was almost identical between these phenotypes (-5.7 ± 15.3% vs -7.7 ± 15.2%, p = 0.49), the high-risk phenotype had a smaller decrease in adjusted 2 h blood glucose levels (-3.7 ± 20.3% vs -18.5 ± 20.0%, p = 0.0009). In addition, only 31% of the participants with the high-risk phenotype, but 67% with the low-risk phenotype, reverted to NGR (p < 0.0001). The odds ratio for reaching the status NGR was 4.54 (95% CI 2.08, 9.94) for participants having the low-risk phenotype. Stratification of individuals with prediabetes at baseline into a high-risk and a low-risk phenotype, based on corrected insulin secretion and insulin-resistant NAFLD, may help to determine the effectiveness of a lifestyle intervention to revert individuals to NGR.

  1. Inequalities in socio-economic characteristics and health and wellbeing of men with and without disabilities: a cross-sectional analysis of the baseline wave of the Australian Longitudinal Study on Male Health.

    PubMed

    Kavanagh, Anne M; Aitken, Zoe; Emerson, Eric; Sahabandu, Sash; Milner, Allison; Bentley, Rebecca; LaMontagne, Anthony D; Pirkis, Jane; Studdert, David

    2016-10-31

    Internationally, men with disabilities have higher rates of social and economic disadvantage and poorer health and wellbeing than men without disabilities. No single study has provided comprehensive, population-level information about the magnitude of such differences among adult men using a well-validated instrument to measure disability. We analysed baseline data from Ten to Men - an Australian longitudinal study of male health. Ten to Men used a stratified multi-stage cluster random sample design to recruit a national sample of males aged 10 to 55 years residing in private dwellings. Data were collected between October 2013 and July 2014 from 15,988 males. This analysis was restricted to 18-55 year old participants with data available on age and disability (n = 13,569). We compared the demographic, socio-economic characteristics and health and wellbeing of men with and without disabilities using chi squared tests for proportions and t tests for continuous variables. Linear regression adjusted for age was used to assess the association between disability status and health and wellbeing, which were measured using the SF-12 mental and physical health component scores and the Personal Wellbeing Index. Men with disabilities were older and more likely to be born in Australia, speak English at home, be Aboriginal and Torres Strait Islander and were less likely to be married or de facto, or to live in urban areas. They were less likely to have completed secondary school, be employed and live in affordable housing, and were more likely to live on low incomes, in more socio-economically disadvantaged areas, and in rental accommodation and to experience shortages of money. Among employed men, those with disabilities were less likely to be in high skilled jobs, worked less hours on average, and were more likely to report that they would prefer to work more. Men with disabilities had lower levels of social support and community participation and poorer mental and

  2. Locomotor dysfunction and risk of cardiovascular disease, quality of life, and medical costs: design of the Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS) and baseline characteristics of the study population.

    PubMed

    Otani, Koji; Takegami, Misa; Fukumori, Norio; Sekiguchi, Miho; Onishi, Yoshihiro; Yamazaki, Shin; Ono, Rei; Otoshi, Kenichi; Hayashino, Yasuaki; Fukuhara, Shunichi; Kikuchi, Shin-Ichi; Konno, Shin-Ichi

    2012-05-01

    There is little evidence regarding long-term outcomes of locomotor dysfunction such as cardiovascular events, quality of life, and death. We are conducting a prospective cohort study to evaluate risk of cardiovascular disease, quality of life, medical costs, and mortality attributable to locomotor dysfunction. The present study determined baseline characteristics of participants in the Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS). Cohort participants were recruited from residents between 40 and 80 years old who received regular health check-ups conducted by local government each year between 2008 and 2010 in Minami-Aizu Town and Tadami Town in Fukushima Prefecture, Japan. Musculoskeletal examination included assessment of physical examination of the cervical and lumbar spine, and upper and lower extremities and of physical function, such as grasping power, one-leg standing time, and time for the 3-m timed up-and-go test. Cardiovascular risk factors, including blood pressure and biological parameters, were measured at annual health check-ups. We also conducted a self-administered questionnaire survey. LOHAS participants comprised 1,289 men (mean age 65.7 years) and 1,954 women (mean age 66.2 years) at the first year. The proportion of obese individuals (body mass index 25.0 kg/m(2)) was 31.9% in men and 34.3% in women, and 41.0% of participants reported being followed up for hypertension, 7.0% for diabetes, and 43.6% for hypercholesterolemia. Prevalence of lumbar spinal stenosis was 10.7% in men and 12.9% in women, while prevalence of low back pain was 15.8% in men and 17.6% in women. The LOHAS is a novel population-based prospective cohort study that will provide an opportunity to estimate the risk of cardiovascular disease, quality of life, medical costs, and mortality attributable to locomotor dysfunction, and to provide the epidemiological information required to develop policies for detection of locomotor dysfunction.

  3. The effect of ginger supplementation on serum C-reactive protein, lipid profile and glycaemia: a systematic review and meta-analysis

    PubMed Central

    Mazidi, Mohsen; Gao, Hong-Kai; Rezaie, Peyman; Ferns, Gordon A.

    2016-01-01

    Aim To undertake a systematic review and meta-analysis of prospective studies to determine the effect of ginger supplementation on serum C-reactive protein (CRP), lipid profile, and glycaemia. Method PubMed-MEDLINE, Web of Science, Cochrane Database, and Google Scholar databases were searched (up until July 2016) to identify prospective studies evaluating the impact of ginger supplementation on serum CRP. Random-effects model meta-analysis was used for quantitative data synthesis. Sensitivity analysis was conducted using the leave-one-out method. Heterogeneity was quantitatively assessed using the I2 index. Systematic review registration: CRD42016035973. Results From a total of 265 entries identified via searches, 9 studies were included in the final selection. The meta-analysis indicated a significant reduction in serum CRP concentrations following ginger supplementation [weighted mean difference (WMD)−0.84 mg/L (95% CI −1.38 to −0.31, I2 56.3%)]. The WMD for fasting blood glucose and HbA1c was −1.35 mg/dl (95% CI −2.04 to −0.58, I2 12.1%) and −1.01 (95% CI −1.28 to −0.72, I2 9.4%), respectively. Moreover, high-density lipoprotein and triglyceride significantly improved after ginger administration [1.16 mg/dl (95% CI 0.52 to 1.08, I2 12.3%) and −1.63 mg/dl (95% CI −3.10 to −0.17, I2 8.1%), respectively]. These findings were robust in sensitivity analyses. Random-effects meta-regression revealed that changes in serum CRP levels were independent of the dosage of ginger supplementation (slope −0.20; 95% CI −0.95 to 0.55; p=0.60). Conclusions This meta-analysis suggests that ginger supplementation significantly reduces serum CRP and improves glycaemia indexes and lipid profile. Randomized control trials with larger sample size and with a longer-term follow-up period should be considered for future investigations. PMID:27806832

  4. Baseline automotive gas turbine engine development program

    NASA Technical Reports Server (NTRS)

    Wagner, C. E. (Editor); Pampreen, R. C. (Editor)

    1979-01-01

    Tests results on a baseline engine are presented to document the automotive gas turbine state-of-the-art at the start of the program. The performance characteristics of the engine and of a vehicle powered by this engine are defined. Component improvement concepts in the baseline engine were evaluated on engine dynamometer tests in the complete vehicle on a chassis dynamometer and on road tests. The concepts included advanced combustors, ceramic regenerators, an integrated control system, low cost turbine material, a continuously variable transmission, power-turbine-driven accessories, power augmentation, and linerless insulation in the engine housing.

  5. Consumption of the Soluble Dietary Fibre Complex PolyGlycopleX(®) Reduces Glycaemia and Increases Satiety of a Standard Meal Postprandially.

    PubMed

    Solah, Vicky A; O'Mara-Wallace, Babette; Meng, Xingqiong; Gahler, Roland J; Kerr, Deborah A; James, Anthony P; Fenton, Haelee K; Johnson, Stuart K; Wood, Simon

    2016-05-06

    The effect of consumption of PolyGlycopleX(®) (PGX(®)) was compared to wheat dextrin (WD) in combination with a standard meal, on postprandial satiety and glycaemia in a double-blind, randomised crossover trial, of 14 healthy subjects trained as a satiety panel. At each of six two-hour satiety sessions, subjects consumed one of three different test meals on two separate occasions. The test meals were: a standard meal plus 5 g PGX; a standard meal plus 4.5 g of PGX as softgels; and a standard meal plus 5 g of WD. Subjects recorded fullness using a labelled magnitude scale at 0, 15, 30, 45, 60, 90, and 120 min and the total area under the curve (AUC), mean fullness vs. time was calculated. The meals with PGX (in granular and softgel form) gave higher satiety (AUC) (477 ± 121 and 454 ± 242 cm·min), than the meal with WD (215 ± 261 cm·min) (p < 0.001). Subjects had blood glucose levels measured after the meals with PGX (granules) and WD. Glucose response (AUC) was significantly lower (p < 0.001) after the PGX meal than for the WD meal.  The high viscosity reported for PGX is a likely mechanism behind the significant satiety and blood glucose modulating effects observed in this study.

  6. Consumption of the Soluble Dietary Fibre Complex PolyGlycopleX® Reduces Glycaemia and Increases Satiety of a Standard Meal Postprandially

    PubMed Central

    Solah, Vicky A.; O’Mara-Wallace, Babette; Meng, Xingqiong; Gahler, Roland J.; Kerr, Deborah A.; James, Anthony P.; Fenton, Haelee K.; Johnson, Stuart K.; Wood, Simon

    2016-01-01

    The effect of consumption of PolyGlycopleX® (PGX®) was compared to wheat dextrin (WD) in combination with a standard meal, on postprandial satiety and glycaemia in a double-blind, randomised crossover trial, of 14 healthy subjects trained as a satiety panel. At each of six two-hour satiety sessions, subjects consumed one of three different test meals on two separate occasions. The test meals were: a standard meal plus 5 g PGX; a standard meal plus 4.5 g of PGX as softgels; and a standard meal plus 5 g of WD. Subjects recorded fullness using a labelled magnitude scale at 0, 15, 30, 45, 60, 90, and 120 min and the total area under the curve (AUC), mean fullness vs. time was calculated. The meals with PGX (in granular and softgel form) gave higher satiety (AUC) (477 ± 121 and 454 ± 242 cm·min), than the meal with WD (215 ± 261 cm·min) (p < 0.001). Subjects had blood glucose levels measured after the meals with PGX (granules) and WD. Glucose response (AUC) was significantly lower (p < 0.001) after the PGX meal than for the WD meal.  The high viscosity reported for PGX is a likely mechanism behind the significant satiety and blood glucose modulating effects observed in this study. PMID:27164135

  7. Appetite control and glycaemia reduction in overweight subjects treated with a combination of two highly standardized extracts from Phaseolus vulgaris and Cynara scolymus.

    PubMed

    Rondanelli, Mariangela; Giacosa, Attilio; Orsini, Francesca; Opizzi, Annalisa; Villani, Simona

    2011-09-01

    The management of overweight may include the use of dietary supplements targeted to favour the increase of the satiation associated with a decrease in blood glucose and lipid levels. The aim of this study was to evaluate the efficacy of a dietary supplementation with an extract from Phaseolus vulgaris and Cynara scolymus, on satiation, the glucose and lipid pattern. A randomized, double-blind, placebo-controlled clinical trial was performed in 39 overweight subjects (20 supplemented group, 19 placebo group) for 2 months. The modification of satiation, by Haber's scale, was the primary end-point, and the variation of the glucose and lipid pattern, of the anthropometric parameters and of the psychodynamic tests score were the secondary end-points. At the end of treatment, the net change of the Haber's mean score increased significantly in the intervention group. The net change of the glycaemia and of the dietary restriction score of the three factor eating questionnaire (TFEQ), were reduced significantly only in the intervention group. Moreover, in the supplemented group, the homeostasis model assessment, the body mass index and the susceptibility-to-hunger score of the TFEQ, decreased significantly after intervention; these parameters did not change in the controls. This treatment appears potentially useful in the management of overweight and dysglycaemia.

  8. Sclerocarya birrea (Anacardiaceae) stem-bark extract corrects glycaemia in diabetic rats and acts on beta-cells by enhancing glucose-stimulated insulin secretion.

    PubMed

    Makom Ndifossap, Ivonne Gisèle; Frigerio, Francesca; Casimir, Marina; Ngueguim Tsofack, Florence; Dongo, Etienne; Kamtchouing, Pierre; Dimo, Théophile; Maechler, Pierre

    2010-04-01

    Sclerocarya birrea is a plant widely used as traditional medication for the treatment of diabetes in sub-Saharan regions. However, the mechanism of action is unknown and only hypoglycaemic effects of S. birrea extract (SBE) in diabetic rats have been reported to date. Here, we tested aqueous extracts of S. birrea on insulin-secreting INS-1E cells and isolated rat islets. Following 24 h of treatment at 5 microg/ml, the extract markedly potentiated glucose-stimulated insulin secretion. Neither basal insulin release nor non-nutrient stimulation was affected. The potentiation of the secretory response at stimulatory glucose appeared after 12 h of treatment. No acute effects were observed and, at the effective concentration, SBE was safe regarding cell integrity and differentiation. The mechanism of action of the SBE was related to glucose metabolism as both ATP generation and glucose oxidation were enhanced following the 24-h treatment. In streptozotocin-induced diabetic rats, SBE administration corrected glycaemia and restored plasma insulin levels after 2 weeks of treatment. These data show direct action of S. birrea on insulin-secreting cells and favour further delineation for use of the plant in the management of diabetes.

  9. Baseline Familiarity in Lie Detection.

    ERIC Educational Resources Information Center

    Feeley, Thomas H.; And Others

    1995-01-01

    Reports on a study in which subjects judged the veracity of truthful and deceptive communicators after viewing no, one, two, or four case-relevant baseline exposures (familiarity) of truthful communication. Finds a positive linear relationship between detection accuracy and amount of baseline familiarity. (SR)

  10. Hanford Site technical baseline database

    SciTech Connect

    Porter, P.E., Westinghouse Hanford

    1996-05-10

    This document includes a cassette tape that contains the Hanford specific files that make up the Hanford Site Technical Baseline Database as of May 10, 1996. The cassette tape also includes the delta files that delineate the differences between this revision and revision 3 (April 10, 1996) of the Hanford Site Technical Baseline Database.

  11. Baseline Familiarity in Lie Detection.

    ERIC Educational Resources Information Center

    Feeley, Thomas H.; And Others

    1995-01-01

    Reports on a study in which subjects judged the veracity of truthful and deceptive communicators after viewing no, one, two, or four case-relevant baseline exposures (familiarity) of truthful communication. Finds a positive linear relationship between detection accuracy and amount of baseline familiarity. (SR)

  12. Plutonium Immobilization Project Baseline Formulation

    SciTech Connect

    Ebbinghaus, B.

    1999-02-01

    A key milestone for the Immobilization Project (AOP Milestone 3.2a) in Fiscal Year 1998 (FY98) is the definition of the baseline composition or formulation for the plutonium ceramic form. The baseline formulation for the plutonium ceramic product must be finalized before the repository- and plant-related process specifications can be determined. The baseline formulation that is currently specified is given in Table 1.1. In addition to the baseline formulation specification, this report provides specifications for two alternative formulations, related compositional specifications (e.g., precursor compositions and mixing recipes), and other preliminary form and process specifications that are linked to the baseline formulation. The preliminary specifications, when finalized, are not expected to vary tremendously from the preliminary values given.

  13. Increased postprandial glycaemia, insulinemia, and lipidemia after 10 weeks’ sucrose-rich diet compared to an artificially sweetened diet: a randomised controlled trial

    PubMed Central

    Raben, Anne; Møller, Bente K.; Flint, Anne; Vasilaras, Tatjana H.; Christina Møller, A.; Juul Holst, Jens; Astrup, Arne

    2011-01-01

    Background The importance of exchanging sucrose for artificial sweeteners on risk factors for developing diabetes and cardiovascular diseases is not yet clear. Objective To investigate the effects of a diet high in sucrose versus a diet high in artificial sweeteners on fasting and postprandial metabolic profiles after 10 weeks. Design Healthy overweight subjects were randomised to consume drinks and foods sweetened with either sucrose (∼2 g/kg body weight) (n = 12) or artificial sweeteners (n = 11) as supplements to their usual diet. Supplements were similar on the two diets and consisted of beverages (∼80 weight%) and solid foods (yoghurts, marmalade, ice cream, stewed fruits). The rest of the diet was free of choice and ad libitum. Before (week 0) and after the intervention (week 10) fasting blood samples were drawn and in week 10, postprandial blood was sampled during an 8-hour meal test (breakfast and lunch). Results After 10 weeks postprandial glucose, insulin, lactate, triglyceride, leptin, glucagon, and GLP-1 were all significantly higher in the sucrose compared with the sweetener group. After adjusting for differences in body weight changes and fasting values (week 10), postprandial glucose, lactate, insulin, GIP, and GLP-1 were significantly higher and after further adjusting for differences in energy and sucrose intake, postprandial lactate, insulin, GIP, and GLP-1 levels were still significantly higher on the sucrose-rich diet. Conclusion A sucrose-rich diet consumed for 10 weeks resulted in significant elevations of postprandial glycaemia, insulinemia, and lipidemia compared to a diet rich in artificial sweeteners in slightly overweight healthy subjects. PMID:21799667

  14. Managing glycaemia in older people with type 2 diabetes: A retrospective, primary care-based cohort study, with economic assessment of patient outcomes.

    PubMed

    Gordon, Jason; McEwan, Phil; Evans, Marc; Puelles, Jorge; Sinclair, Alan

    2017-05-01

    To describe the relative health and economic outcomes associated with different second-line therapeutic approaches to manage glycaemia in older type 2 diabetes patients requiring escalation from metformin monotherapy. The Clinical Practice Research Datalink database was used to inform a retrospective observational cohort study of patients with type 2 diabetes treated with metformin monotherapy requiring escalation (addition or switch) to a second-line oral regimen from January 1, 2008 to December 31, 2014. Primary outcomes included time to first event (any event, myocardial infarction [MI], stroke, or composite of MI/stroke [major adverse cardiovascular event; MACE]) and total event rate. The health economic consequences associated with the choice of second-line treatment in older patients were assessed using the CORE Diabetes Model. A total of 10 484 patients were included; the majority escalated to second-line treatment with metformin + sulphonylurea (SU; 42%) or switched to SU monotherapy (28%). In multivariate adjusted analyses, total event rates for MACE with metformin + dipeptidyl peptidase-4 (DPP-4) inhibitor were significantly lower than with metformin + SU (0.61, 95% confidence interval [CI] 0.39-0.98), driven by a lower MI rate in the metformin + DPP-4 inhibitor group (0.52, 95% CI 0.27-0.99). Economic analyses estimated that metformin + DPP-4 inhibitor treatment was associated with the largest gain in health benefit, and cost-effectiveness ratios were favourable (<£30 000 per quality-adjusted life-year) for all second-line treatment scenarios. With respect to treatment choice, data from the present study support the notion of prescribing beyond metformin + SU, as alternative regimens have been shown to be associated with reduced outcomes risk and value for money. © 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  15. Taking Healthy Steps: rationale, design and baseline characteristics of a randomized trial of a pedometer-based Internet-mediated walking program in veterans with chronic obstructive pulmonary disease.

    PubMed

    Martinez, Carlos H; Moy, Marilyn L; Nguyen, Huong Q; Cohen, Miriam; Kadri, Reema; Roman, Pia; Holleman, Robert G; Kim, Hyungjin Myra; Goodrich, David E; Giardino, Nicholas D; Richardson, Caroline R

    2014-02-03

    Low levels of physical activity are common in patients with chronic obstructive pulmonary disease (COPD), and a sedentary lifestyle is associated with poor outcomes including increased mortality, frequent hospitalizations, and poor health-related quality of life. Internet-mediated physical activity interventions may increase physical activity and improve health outcomes in persons with COPD. This manuscript describes the design and rationale of a randomized controlled trial that tests the effectiveness of Taking Healthy Steps, an Internet-mediated walking program for Veterans with COPD. Taking Healthy Steps includes an uploading pedometer, a website, and an online community. Eligible and consented patients wear a pedometer to obtain one week of baseline data and then are randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control. The intervention arm receives iterative step-count feedback; individualized step-count goals, motivational and informational messages, and access to an online community. Wait list controls are notified that they are enrolled, but that their intervention will start in one year; however, they keep the pedometer and have access to a static webpage. Participants include 239 Veterans (mean age 66.7 years, 93.7% male) with 155 randomized to Taking Healthy Steps and 84 to the wait list control arm; rural-living (45.2%); ever-smokers (93.3%); and current smokers (25.1%). Baseline mean St. George's Respiratory Questionnaire Total Score was 46.0; 30.5% reported severe dyspnea; and the average number of comorbid conditions was 4.9. Mean baseline daily step counts was 3497 (+/- 2220).Veterans with COPD can be recruited to participate in an online walking program. We successfully recruited a cohort of older Veterans with a significant level of disability including Veterans who live in rural areas using a remote national recruitment strategy. Clinical Trials.gov NCT01102777.

  16. Rationale, Design, and Baseline Characteristics of Beijing Prediabetes Reversion Program: A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Lifestyle Intervention and/or Pioglitazone in Reversion to Normal Glucose Tolerance in Prediabetes

    PubMed Central

    Luo, Yingying; Paul, Sanjoy K.; Zhou, Xianghai; Chang, Cuiqing; Guo, Xiaohui; Yang, Jinkui

    2017-01-01

    Background. Patients with prediabetes are at high risk for diabetes and cardiovascular disease (CVD). No study has explored whether intervention could revert prediabetes to normal glycemic status as the primary outcome. Beijing Prediabetes Reversion Program (BPRP) would evaluate whether intensive lifestyle modification and/or pioglitazone could revert prediabetic state to normoglycemia and improve the risk factors of CVD as well. Methods. BPRP is a randomized, multicenter, 2 × 2 factorial design study. Participants diagnosed as prediabetes were randomized into four groups (conventional/intensive lifestyle intervention and 30 mg pioglitazone/placebo) with a three-year follow-up. The primary endpoint was conversion into normal glucose tolerance. The trial would recruit 2000 participants (500 in each arm). Results. Between March 2007 and March 2011, 1945 participants were randomized. At baseline, the individuals were 53 ± 10 years old, with median BMI 26.0 (23.9, 28.2) kg/m2 and HbA1c 5.8 (5.6, 6.1)%. 85% of the participants had IGT and 15% had IFG. Parameters relevant to glucose, lipids, blood pressure, lifestyle, and other metabolic markers were similar between conventional and intensive lifestyle intervention group at baseline. Conclusion. BPRP was the first study to determine if lifestyle modification and/or pioglitazone could revert prediabetic state to normoglycemia in Chinese population. Major baseline parameters were balanced between two lifestyle intervention groups. This trial is registered with www.chictr.org.cn: ChiCTR-PRC-06000005. PMID:28168204

  17. Rationale, Design, and Baseline Characteristics of Beijing Prediabetes Reversion Program: A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Lifestyle Intervention and/or Pioglitazone in Reversion to Normal Glucose Tolerance in Prediabetes.

    PubMed

    Luo, Yingying; Paul, Sanjoy K; Zhou, Xianghai; Chang, Cuiqing; Chen, Wei; Guo, Xiaohui; Yang, Jinkui; Ji, Linong; Wang, Hongyuan

    2017-01-01

    Background. Patients with prediabetes are at high risk for diabetes and cardiovascular disease (CVD). No study has explored whether intervention could revert prediabetes to normal glycemic status as the primary outcome. Beijing Prediabetes Reversion Program (BPRP) would evaluate whether intensive lifestyle modification and/or pioglitazone could revert prediabetic state to normoglycemia and improve the risk factors of CVD as well. Methods. BPRP is a randomized, multicenter, 2 × 2 factorial design study. Participants diagnosed as prediabetes were randomized into four groups (conventional/intensive lifestyle intervention and 30 mg pioglitazone/placebo) with a three-year follow-up. The primary endpoint was conversion into normal glucose tolerance. The trial would recruit 2000 participants (500 in each arm). Results. Between March 2007 and March 2011, 1945 participants were randomized. At baseline, the individuals were 53 ± 10 years old, with median BMI 26.0 (23.9, 28.2) kg/m(2) and HbA1c 5.8 (5.6, 6.1)%. 85% of the participants had IGT and 15% had IFG. Parameters relevant to glucose, lipids, blood pressure, lifestyle, and other metabolic markers were similar between conventional and intensive lifestyle intervention group at baseline. Conclusion. BPRP was the first study to determine if lifestyle modification and/or pioglitazone could revert prediabetic state to normoglycemia in Chinese population. Major baseline parameters were balanced between two lifestyle intervention groups. This trial is registered with www.chictr.org.cn: ChiCTR-PRC-06000005.

  18. Baseline characteristics and interim (3-month) efficacy and safety data from STELLA-LONG TERM, a long-term post-marketing surveillance study of ipragliflozin in Japanese patients with type 2 diabetes in real-world clinical practice.

    PubMed

    Maegawa, Hiroshi; Tobe, Kazuyuki; Tabuchi, Hiromi; Nakamura, Ichiro

    2016-10-01

    To evaluate the efficacy and safety of ipragliflozin in real-world clinical practice in Japanese patients with type 2 diabetes. We conducted interim analyses at 3 months of a 3-year prospective study of patients who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015, and whose data were locked by 16 January 2016. Changes in glycemic control, blood pressure, and laboratory variables from baseline, and incidence of adverse drug reactions (ADRs). Of 11,412 patients initially registered, efficacy and safety data were available for 3481 (30.5%) and 4360 (38.2%) patients, respectively. Hemoglobin A1c and fasting plasma glucose decreased by 0.67% and 28.8 mg/dL, respectively, at 3 months/last assessment (both P < .001) from baseline (8.00% and 166.4 mg/dL, respectively). Blood pressure and lipid levels also improved significantly. There were 258 ADRs in 194 patients. The ADRs included 'renal and urinary disorders' (system organ class) in 110 patients (2.5%). These 3-month interim results indicate that ipragliflozin improved glycemic control, lipids, and blood pressure with low rates of ADRs in Japanese patients with type 2 diabetes in real-world clinical practice. The results were consistent with those of placebo-controlled, randomized clinical trials. Clinicaltrials.gov identifier: NCT02479399.

  19. Treadmill Kinematics Baseline Data Collection

    NASA Image and Video Library

    2011-05-12

    PHOTO DATE: 5-12-11 LOCATION: Building 261 - Room 138 SUBJECT: Expedition 29 Preflight Training with Dan Burbank during Treadmill Kinematics Baseline Data Collection. WORK ORDER: 2011-1214 PHOTOGRAPHER: Lauren Harnett

  20. 324 Building Baseline Radiological Characterization

    SciTech Connect

    R.J. Reeder, J.C. Cooper

    2010-06-24

    This report documents the analysis of radiological data collected as part of the characterization study performed in 1998. The study was performed to create a baseline of the radiological conditions in the 324 Building.

  1. Coastal Surveillance Baseline Model Development

    DTIC Science & Technology

    2015-02-27

    These sensors were defined using basic unclassified information from several different sources [15] [16] [17]. DRDC CORA Task #185 Coastal ...unclassified information from several different sources [19] [20] [21]. DRDC CORA Task #185 Coastal Surveillance Baseline Model Development 27 February...Task #185 Coastal Surveillance Baseline Model Development 27 February 2015 – 27 – 5758-001 Version 01 platform from a couple of different perspectives

  2. Ask the experts: chromatographic baselines.

    PubMed

    Smith, Graeme; James, Christopher A; Scott, Rebecca; Woolf, Eric

    2014-05-01

    Bioanalysis invited a selection of leading researchers to express their views on chromatographic baseline assignment in the bioanalytical laboratory. The topics discussed include the challenges presented with ensuring automated baseline assignment is correct, when reintegration is necessary, regulation and consistency in terminology. Their enlightening responses provide a valuable insight into developing an industry consensus towards reintegration. An accompanying commentary article in this issue, authored by Howard Hill and colleagues (Huntingdon Life Sciences), provides background to this much debated topic.

  3. Comparison of non-radiographic axial spondyloarthritis and ankylosing spondylitis patients--baseline characteristics, treatment adherence, and development of clinical variables during three years of anti-TNF therapy in clinical practice.

    PubMed

    Wallman, Johan K; Kapetanovic, Meliha C; Petersson, Ingemar F; Geborek, Pierre; Kristensen, Lars Erik

    2015-12-24

    The relationship between non-radiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) is currently debated. Using observational data from the South Swedish Arthritis Treatment Group register, we thus aimed to compare clinical development and treatment adherence between nr-axSpA and AS patients during three years of anti-TNF (tumor necrosis factor) therapy in clinical practice, and to explore the impact of inflammatory activity measured by CRP (C-reactive protein) at treatment initiation. Nr-axSpA and AS patients (n = 86/238) in southern Sweden, commencing anti-TNF therapy 1999-2011, were followed during three years. Anti-TNF cessation was defined as stopping therapy, without restarting another anti-TNF agent within three months. Differences in the three year developments of patient's visual analogue scale (VAS) scores for global health and pain, EuroQol 5-Dimensions utility, evaluator's global disease activity assessment, CRP, and ESR (erythrocyte sedimentation rate) were assessed by repeated ANOVA. Anti-TNF adherence was compared by Log rank test and Cox regression. In a subanalysis, the same outcomes were studied after splitting both groups into patients with/without baseline CRP elevation. Nr-axSpA patients were more often female and had lower acute phase reactants at baseline. Apart from CRP, which remained lower in the nr-axSpA group throughout follow-up (p = 0.004), no between-group differences were detected regarding clinical developments (p >0.1 for all comparisons) or anti-TNF adherence (hazard ratio: 1.1 (95% CI 0.7 to 1.8) for the nr-axSpA vs. AS group) during three years. Elevated baseline CRP was similarly associated with superior clinical outcomes and treatment adherence in both groups. With the exception of constantly lower CRP levels in the nr-axSpA group, three years anti-TNF therapy resulted in similar clinical outcomes and treatment adherence in nr-axSpA and AS patients, thus strengthening the hypothesis that

  4. CASA Uno GPS orbit and baseline experiments

    NASA Technical Reports Server (NTRS)

    Schutz, B. E.; Ho, C. S.; Abusali, P. A. M.; Tapley, B. D.

    1990-01-01

    CASA Uno data from sites distributed in longitude from Australia to Europe have been used to determine orbits of the GPS satellites. The characteristics of the orbits determined from double difference phase have been evaluated through comparisons of two-week solutions with one-week solutions and by comparisons of predicted and estimated orbits. Evidence of unmodeled effects is demonstrated, particularly associated with the orbit planes that experience solar eclipse. The orbit accuracy has been assessed through the repeatability of unconstrained estimated baseline vectors ranging from 245 km to 5400 km. Both the baseline repeatability and the comparison with independent space geodetic methods give results at the level of 1-2 parts in 100,000,000. In addition, the Mojave/Owens Valley (245 km) and Kokee Park/Ft. Davis (5409 km) estimates agree with VLBI and SLR to better than 1 part in 100,000,000.

  5. CASA Uno GPS orbit and baseline experiments

    NASA Technical Reports Server (NTRS)

    Schutz, B. E.; Ho, C. S.; Abusali, P. A. M.; Tapley, B. D.

    1990-01-01

    CASA Uno data from sites distributed in longitude from Australia to Europe have been used to determine orbits of the GPS satellites. The characteristics of the orbits determined from double difference phase have been evaluated through comparisons of two-week solutions with one-week solutions and by comparisons of predicted and estimated orbits. Evidence of unmodeled effects is demonstrated, particularly associated with the orbit planes that experience solar eclipse. The orbit accuracy has been assessed through the repeatability of unconstrained estimated baseline vectors ranging from 245 km to 5400 km. Both the baseline repeatability and the comparison with independent space geodetic methods give results at the level of 1-2 parts in 100,000,000. In addition, the Mojave/Owens Valley (245 km) and Kokee Park/Ft. Davis (5409 km) estimates agree with VLBI and SLR to better than 1 part in 100,000,000.

  6. Population Study of Urban, Rural, and Semiurban Regions for the Detection of Endovascular Disease and Prevalence of Risk Factors and Holistic Intervention Study: Rationale, Study Design, and Baseline Characteristics of PURSE-HIS.

    PubMed

    Thanikachalam, Sadagopan; Harivanzan, Vijayakumar; Mahadevan, Murugappapillai V; Murthy, J S N; Anbarasi, Chandrasekar; Saravanababu, Chidambaram S; Must, Aviva; Baliga, Ragavendra R; Abraham, William T; Thanikachalam, Mohan

    2015-12-01

    We designed and implemented the PURSE-HIS (Population Study of Urban, Rural and Semiurban Regions for the Detection of Endovascular Disease and Prevalence of Risk Factors and Holistic Intervention Study) to understand the prevalence and progression of subclinical and overt endovascular disease (EVD) and its risk factors in urban, semiurban, and rural communities in South India. The study is also designed to generate clinical evidence for effective, affordable, and sustainable community-specific intervention strategies to control risks factors for EVD. As of June 2012, 8,080 (urban: 2,221; semiurban: 2,821; rural: 3,038) participants >20 years of age were recruited using 2-stage cluster sampling. Baseline measurements included standard cardiovascular disease risk factors, sociodemographic factors, lifestyle habits, psychosocial factors, and nutritional assessment. Fasting blood samples were assayed for putative biochemical risk factors and urine samples for microalbuminuria. All nondiabetic participants underwent oral glucose tolerance test with blood and urine samples collected every 30 min for 2 h. Additional baseline measurements included flow-mediated brachial artery endothelial vasodilation, assessment of carotid intimal medial wall thickness using ultrasonography, screening for peripheral vascular disease using ankle and brachial blood pressures, hemodynamic screening using a high-fidelity applanation tonometry to measure central blood pressure parameters, and aortic pulse wave velocity. To assess prevalence of coronary artery disease, all participants underwent surface electrocardiography and documentation of ventricular wall motion abnormality and function using echocardiography imaging. To detect subclinical lesions, all eligible participants completed an exercise treadmill test. Prospectively, the study will assess progression of subclinical and overt EVD, including risk factor-outcome relation differences across communities. The study will also evaluate

  7. Rationale, design, and baseline characteristics of the Acetylcystein for Contrast-Induced nephropaThy (ACT) Trial: a pragmatic randomized controlled trial to evaluate the efficacy of acetylcysteine for the prevention of contrast-induced nephropathy

    PubMed Central

    2009-01-01

    Background Aceltylcysteine has been evaluated in several small trials as a means of reducing the risk of contrast-induced nephropathy (CIN), however systematic reviews of these studies do not provide conclusive answers. Therefore, a large randomized controlled trial (RCT) is needed to provide a reliable answer as to whether acetylcysteine is effective in decreasing the risk of CIN in high-risk patients undergoing angiographic procedures. Methods ACT is a RCT of acetylcysteine versus placebo in 2,300 patients at-risk for CIN undergoing an intravascular angiographic procedure. The randomization list will be concealed. Participants, health care staff, investigators and outcome assessors will be blinded to whether patients receive acetylcysteine or placebo. All analysis will follow the intention-to-treat principle. The study drugs (acetylcysteine 1200 mg or placebo) will be administered orally twice daily for two doses before and two doses after the procedure. The primary outcome is the occurrence of CIN, defined as a 25% elevation of serum creatinine above baseline between 48 and 96 hours after angiography. Discussion The first patient entered the trial on September, 2008. Up to April 7, 2009, 810 patients had been included in 35 centers. The mean age was 69 (Standard deviation: 10), 18% had a baseline serum creatinine >1.5 mg/dL, 57% were diabetics and 13% had a history of heart failure. The ongoing ACT Trial is the largest multicentre RCT that will determine whether acetylcysteine is effective in decreasing the risk of CIN in patients at risk undergoing angiography. Trial registration Clinicaltrials.gov NCT00736866 PMID:19497091

  8. Rationale, design, and baseline characteristics of the Acetylcystein for Contrast-Induced nephropaThy (ACT) Trial: a pragmatic randomized controlled trial to evaluate the efficacy of acetylcysteine for the prevention of contrast-induced nephropathy.

    PubMed

    2009-06-04

    Aceltylcysteine has been evaluated in several small trials as a means of reducing the risk of contrast-induced nephropathy (CIN), however systematic reviews of these studies do not provide conclusive answers. Therefore, a large randomized controlled trial (RCT) is needed to provide a reliable answer as to whether acetylcysteine is effective in decreasing the risk of CIN in high-risk patients undergoing angiographic procedures. ACT is a RCT of acetylcysteine versus placebo in 2,300 patients at-risk for CIN undergoing an intravascular angiographic procedure. The randomization list will be concealed. Participants, health care staff, investigators and outcome assessors will be blinded to whether patients receive acetylcysteine or placebo. All analysis will follow the intention-to-treat principle. The study drugs (acetylcysteine 1200 mg or placebo) will be administered orally twice daily for two doses before and two doses after the procedure. The primary outcome is the occurrence of CIN, defined as a 25% elevation of serum creatinine above baseline between 48 and 96 hours after angiography. The first patient entered the trial on September, 2008. Up to April 7, 2009, 810 patients had been included in 35 centers. The mean age was 69 (Standard deviation: 10), 18% had a baseline serum creatinine >1.5 mg/dL, 57% were diabetics and 13% had a history of heart failure. The ongoing ACT Trial is the largest multicentre RCT that will determine whether acetylcysteine is effective in decreasing the risk of CIN in patients at risk undergoing angiography. Clinicaltrials.gov NCT00736866.

  9. Baseline Factors Predictive of SLT Response: A Prospective Study.

    PubMed

    Bruen, Robin; Lesk, Mark R; Harasymowycz, Paul

    2012-01-01

    Purpose. To study the response to Selective Laser Trabeculoplasty (SLT) according to baseline medical treatment, angle pigmentation, age, diagnosis (open-angle glaucoma or ocular hypertension), and baseline intraocular pressure (IOP). Methods. 74 eyes of 74 patients were enrolled in this study. Baseline characteristics were recorded for each patient. IOP in the treated and fellow eyes was measured at baseline, and 1 month, 6 months, and 12 months following SLT. IOP changes in the different groups were compared using two-way ANOVA and Pearson's correlation. Results. The mean age of our cohort was 71 ± 10 years. The mean baseline IOP was 21.5 ± 5 mmHg, and the mean change in IOP from baseline in the treated eye at one year was -4.67 ± 3.40 mmHg. Higher baseline IOP was highly correlated with greater absolute IOP decrease. Prostaglandin analogue use at baseline was shown to be associated with a statistically decreased IOP-lowering response following SLT when corrected for baseline IOP. No significant differences in IOP response were found when comparing groups stratified for age, angle pigmentation, phakic status, gender, or diagnosis. Discussion. The results of this study confirm the finding that higher baseline IOP is a predictor of greater IOP response following SLT, and that pretreatment with prostaglandin analogue therapy is associated with a decreased IOP-lowering response following SLT. The study is limited by the small number of eyes with data available for complete case analysis.

  10. Developing RESRAD-BASELINE for environmental baseline risk assessment

    SciTech Connect

    Cheng, Jing-Jy

    1995-12-31

    RESRAD-BASELINE is a computer code developed at Argonne developed at Argonne National Laboratory for the US Department of Energy (DOE) to perform both radiological and chemical risk assessments. The code implements the baseline risk assessment guidance of the US Environmental Protection Agency (EPA 1989). The computer code calculates (1) radiation doses and cancer risks from exposure to radioactive materials, and (2) hazard indexes and cancer risks from exposure to noncarcinogenic and carcinogenic chemicals, respectively. The user can enter measured or predicted environmental media concentrations from the graphic interface and can simulate different exposure scenarios by selecting the appropriate pathways and modifying the exposure parameters. The database used by PESRAD-BASELINE includes dose conversion factors and slope factors for radionuclides and toxicity information and properties for chemicals. The user can modify the database for use in the calculation. Sensitivity analysis can be performed while running the computer code to examine the influence of the input parameters. Use of RESRAD-BASELINE for risk analysis is easy, fast, and cost-saving. Furthermore, it ensures in consistency in methodology for both radiological and chemical risk analyses.

  11. CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (the CORDIOPREV study): Rationale, methods, and baseline characteristics: A clinical trial comparing the efficacy of a Mediterranean diet rich in olive oil versus a low-fat diet on cardiovascular disease in coronary patients.

    PubMed

    Delgado-Lista, Javier; Perez-Martinez, Pablo; Garcia-Rios, Antonio; Alcala-Diaz, Juan F; Perez-Caballero, Ana I; Gomez-Delgado, Francisco; Fuentes, Francisco; Quintana-Navarro, Gracia; Lopez-Segura, Fernando; Ortiz-Morales, Ana M; Delgado-Casado, Nieves; Yubero-Serrano, Elena M; Camargo, Antonio; Marin, Carmen; Rodriguez-Cantalejo, Fernando; Gomez-Luna, Purificacion; Ordovas, Jose M; Lopez-Miranda, Jose; Perez-Jimenez, Francisco

    2016-07-01

    Coronary heart disease (CHD) represents a major global health burden. However, despite the well-known influence that dietary habits exert over the progression of this disease, there are no well-established and scientifically sound dietary approaches to prevent the onset of clinical outcomes in secondary prevention. The objective of the CORonary Diet Intervention with Olive oil and cardiovascular PREVention study (CORDIOPREV study, clinical trials number NCT00924937) is to compare the ability of a Mediterranean diet rich in virgin olive oil versus a low-fat diet to influence the composite incidence of cardiovascular events after 7 years in subjects with documented CHD at baseline. For this purpose, we enrolled 1,002 coronary patients from Spain. Baseline assessment (2009-2012) included detailed interviews and measurements to assess dietary, social, and biological variables. Results of baseline characteristics: The CORDIOPREV study in Spain describes a population with a high body mass index (37.2% overweight and 56.3% obesity) and with a median of low-density lipoprotein cholesterol of 88.5 mg/dL (70.6% of the patients having <100 mg/dL and 20.3% patients <70 mg/dL). A total of 9.6% of the participants were active smokers, and 64.4% were former smokers. Metabolic syndrome was present in 58% of this population. To sum up, we describe here the rationale, methods, and baseline characteristics of the CORDIOPREV study, which will test for the first time the efficacy of a Mediterranean diet rich in extra virgin olive oil as compared with a low-fat diet on the incidence of CHD recurrence in a long-term follow-up study. Copyright © 2016 Elsevier, Inc. All rights reserved.

  12. Retinal characteristics during 1 year of insulin pump therapy in type 1 diabetes: a prospective, controlled, observational study.

    PubMed

    Klefter, Oliver Niels; Hommel, Eva; Munch, Inger Christine; Nørgaard, Kirsten; Madsbad, Sten; Larsen, Michael

    2016-09-01

    To investigate changes in retinal metabolism, function, structure and morphology in relation to initiation of insulin pump therapy (continuous subcutaneous insulin infusion, CSII). Visual acuity, retinopathy level, dark adaptation kinetics, retinal and subfoveal choroidal thickness, macular perfusion velocities, retinal vessel diameters and blood oxygen saturations were measured at baseline and after 1, 4, 16, 32 and 52 weeks in 31 patients with type 1 diabetes who started CSII and 20 patients who continued multiple daily insulin injections (MDI). One year of CSII reduced haemoglobin A1c (HbA1c ) by 1.6% (17.8 mmol/mol) compared with 0.3% (3.1 mmol/mol) in the MDI group (p < 0.0001). Central retinal thickness increased by 1.5% in the CSII group (within-group p = 0.0098; between-group p = 0.063) without producing macular oedema. No detectable change was found in any other primary outcome measure. The proportion of patients with retinopathy worsening did not differ between groups. At baseline, longer disease duration was associated with higher retinal artery oxygen saturation (p = 0.014) and lower macular venous perfusion velocity (p = 0.045). One year of CSII led to an HbA1c reduction relative to continued MDI and a small increase in retinal thickness but not to early retinopathy worsening or to changes in retinal vascular, structural or functional characteristics. Longer duration of type 1 diabetes appears to be associated with lower macular venous perfusion velocity and higher retinal artery oxygen saturation. The latter could potentially reflect cumulative glycaemia. © 2016 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  13. Integrated Baseline Review (IBR) Handbook

    NASA Technical Reports Server (NTRS)

    2013-01-01

    An Integrated Baseline Review (IBR) is a review of a supplier?s Performance Measurement Baseline (PMB). It is conducted by Program/Project Managers and their technical staffs on contracts and in-house work requiring compliance with NASA Earned Value Management System (EVMS) policy as defined in program/project policy, NPR 7120.5, or in NASA Federal Acquisition Regulations. The IBR Handbook may also be of use to those responsible for preparing the Terms of Reference for internal project reviews. While risks may be identified and actions tracked as a result of the IBR, it is important to note that an IBR cannot be failed.

  14. Project FIT: rationale, design and baseline characteristics of a school- and community-based intervention to address physical activity and healthy eating among low-income elementary school children.

    PubMed

    Eisenmann, Joey C; Alaimo, Katherine; Pfeiffer, Karin; Paek, Hye-Jin; Carlson, Joseph J; Hayes, Heather; Thompson, Tracy; Kelleher, Deanne; Oh, Hyun J; Orth, Julie; Randall, Sue; Mayfield, Kellie; Holmes, Denise

    2011-07-29

    This paper describes Project FIT, a collaboration between the public school system, local health systems, physicians, neighborhood associations, businesses, faith-based leaders, community agencies and university researchers to develop a multi-faceted approach to promote physical activity and healthy eating toward the general goal of preventing and reducing childhood obesity among children in Grand Rapids, MI, USA. There are four overall components to Project FIT: school, community, social marketing, and school staff wellness - all that focus on: 1) increasing access to safe and affordable physical activity and nutrition education opportunities in the schools and surrounding neighborhoods; 2) improving the affordability and availability of nutritious food in the neighborhoods surrounding the schools; 3) improving the knowledge, self-efficacy, attitudes and behaviors regarding nutrition and physical activity among school staff, parents and students; 4) impacting the 'culture' of the schools and neighborhoods to incorporate healthful values; and 5) encouraging dialogue among all community partners to leverage existing programs and introduce new ones. At baseline, there was generally low physical activity (70% do not meet recommendation of 60 minutes per day), excessive screen time (75% do not meet recommendation of < 2 hours per day), and low intake of vegetables and whole grains and high intake of sugar-sweetened beverages, French fries and chips and desserts as well as a high prevalence of overweight and obesity (48.5% including 6% with severe obesity) among low income, primarily Hispanic and African American 3rd-5th grade children (n = 403). ClinicalTrials.gov NCT01385046.

  15. SRP Baseline Hydrogeologic Investigation, Phase 3

    SciTech Connect

    Bledsoe, H.W.

    1988-08-01

    The SRP Baseline Hydrogeologic Investigation was implemented for the purpose of updating and improving the knowledge and understanding of the hydrogeologic systems underlying the SRP site. Phase III, which is discussed in this report, includes the drilling of 7 deep coreholes (sites P-24 through P-30) and the installation of 53 observation wells ranging in depth from approximately 50 ft to more than 970 ft below the ground surface. In addition to the collection of geologic cores for lithologic and stratigraphic study, samples were also collected for the determination of physical characteristics of the sediments and for the identification of microorganisms.

  16. Baseline Report on HB2320

    ERIC Educational Resources Information Center

    State Council of Higher Education for Virginia, 2015

    2015-01-01

    Staff provides this baseline report as a summary of its preliminary considerations and initial research in fulfillment of the requirements of HB2320 from the 2015 session of the General Assembly. Codified as § 23-7.4:7, this legislation compels the Education Secretary and the State Council of Higher Education for Virginia (SCHEV) Director, in…

  17. Baseline Removal From EMG Recordings

    DTIC Science & Technology

    2007-11-02

    registers in which the main spike of the MUAP occupies the central position) [1]; or else just give the BL a zero level (system ground). We regard...a time-varying baseline contamination. Acknowledgements: Work funded by the Departamento de Salud del Gobierno de Navarrra and by a Spanish MEC

  18. Project FIT: Rationale, design and baseline characteristics of a school- and community-based intervention to address physical activity and healthy eating among low-income elementary school children

    PubMed Central

    2011-01-01

    Background This paper describes Project FIT, a collaboration between the public school system, local health systems, physicians, neighborhood associations, businesses, faith-based leaders, community agencies and university researchers to develop a multi-faceted approach to promote physical activity and healthy eating toward the general goal of preventing and reducing childhood obesity among children in Grand Rapids, MI, USA. Methods/design There are four overall components to Project FIT: school, community, social marketing, and school staff wellness - all that focus on: 1) increasing access to safe and affordable physical activity and nutrition education opportunities in the schools and surrounding neighborhoods; 2) improving the affordability and availability of nutritious food in the neighborhoods surrounding the schools; 3) improving the knowledge, self-efficacy, attitudes and behaviors regarding nutrition and physical activity among school staff, parents and students; 4) impacting the 'culture' of the schools and neighborhoods to incorporate healthful values; and 5) encouraging dialogue among all community partners to leverage existing programs and introduce new ones. Discussion At baseline, there was generally low physical activity (70% do not meet recommendation of 60 minutes per day), excessive screen time (75% do not meet recommendation of < 2 hours per day), and low intake of vegetables and whole grains and high intake of sugar-sweetened beverages, French fries and chips and desserts as well as a high prevalence of overweight and obesity (48.5% including 6% with severe obesity) among low income, primarily Hispanic and African American 3rd-5th grade children (n = 403). Trial registration ClinicalTrials.gov NCT01385046 PMID:21801411

  19. Paricalcitol versus cinacalcet plus low-dose vitamin D for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: study design and baseline characteristics of the IMPACT SHPT study

    PubMed Central

    Martin, Kevin J.; Cozzolino, Mario; Goldsmith, David; Sharma, Amit; Khan, Samina; Dumas, Emily; Amdahl, Michael; Marx, Steven; Audhya, Paul

    2012-01-01

    Background. Paricalcitol and cinacalcet are common therapies for patients on haemodialysis with secondary hyperparathyroidism (SHPT). We conducted a multi-centre study in 12 countries to compare the safety and efficacy of paricalcitol and cinacalcet for the treatment of SHPT. Methods. Patients aged ≥18 years with Stage 5 chronic kidney disease receiving maintenance haemodialysis and with intact parathyroid hormone (iPTH) 300–800 pg/mL, calcium 8.4–10.0 mg/dL (2.09–2.49 mmol/L) and phosphorus ≤6.5 mg/dL (2.09 mmol/L) were randomized within two strata defined by the mode of paricalcitol administration to treatment with paricalcitol- (intra-venous, US and Russian sites, IV stratum; oral, non-US and non-Russian sites, oral stratum) or cinacalcet-centred therapy. The primary endpoint is the proportion of patients in each treatment group who achieve a mean iPTH value of 150–300 pg/mL during Weeks 21–28 of treatment. Assuming efficacy response rates of 36 and 66% for cinacalcet and paricalcitol, respectively, and a 20% discontinuation rate, 124 subjects in each stratum were estimated to provide 81% power to detect a 30% absolute difference in the primary endpoint. Results. Of 746 patients screened, 272 (mean age, 63 years; mean iPTH, 509 pg/mL) were randomized. Mean duration of haemodialysis at baseline was 3.7 years. Comorbidities included hypertension (90.4%), Type 2 diabetes (40.4%), congestive heart failure (17.3%), coronary artery disease (34.6%) and gastrointestinal disorders (75%). Conclusions. The study participants are representative of a multinational cohort of patients on haemodialysis with elevated iPTH. The study results will provide valuable information on the best available treatment of SHPT in patients on haemodialysis. PMID:21931122

  20. Comparison of Baseline Characteristics between Community-based and Hospital-based Suicidal Ideators and Its Implications for Tailoring Strategies for Suicide Prevention: Korean Cohort for the Model Predicting a Suicide and Suicide-related Behavior

    PubMed Central

    2017-01-01

    In this cross-sectional study, we aimed to identify distinguishing factors between populations with suicidal ideation recruited from hospitals and communities to make an efficient allocation of limited anti-suicidal resources according to group differences. We analyzed the baseline data from 120 individuals in a community-based cohort (CC) and 137 individuals in a hospital-based cohort (HC) with suicidal ideation obtained from the Korean Cohort for the Model Predicting a Suicide and Suicide-related Behavior (K-COMPASS) study. First, their sociodemographic factors, histories of medical and psychiatric illnesses, and suicidal behaviors were compared. Second, diagnosis by the Korean version of the Mini International Neuropsychiatric Interview, scores of psychometric scales were used to assess differences in clinical severity between the groups. The results revealed that the HC had more severe clinical features: more psychiatric diagnosis including current and recurrent major depressive episodes (odds ratio [OR], 4.054; P < 0.001 and OR, 11.432; P < 0.001, respectively), current suicide risk (OR, 4.817; P < 0.001), past manic episodes (OR, 9.500; P < 0.001), past hypomanic episodes (OR, 4.108; P = 0.008), current alcohol abuse (OR, 3.566; P = 0.020), and current mood disorder with psychotic features (OR, 20.342; P < 0.001) besides significantly higher scores in depression, anxiety, alcohol problems, impulsivity, and stress. By comparison, old age, single households, and low socioeconomic status were significantly associated with the CC. These findings indicate the necessity of more clinically oriented support for hospital visitors and more socioeconomic aid for community-dwellers with suicidality. PMID:28776350

  1. The Mexican-American Trial of Community Health workers (MATCH): Design and baseline characteristics of a randomized controlled trial testing a culturally tailored community diabetes self-management intervention

    PubMed Central

    Rothschild, Steven K.; Martin, Molly A.; Swider, Susan M.; Lynas, Carmen T.; Avery, Elizabeth F.; Janssen, Imke; Powell, Lynda H.

    2012-01-01

    Objectives Community Health Workers (CHWs) have been recommended to reduce diabetes disparities, but few robust trials of this approach have been conducted. Limitations of prior studies include: unspecified a priori outcomes; lack of blinded outcome assessments; high participant attrition rates; and lack of attention to intervention fidelity. These limitations reflect challenges in balancing methodologic rigor with the needs of vulnerable populations. The Mexican-American Trial of Community Health workers (MATCH) was a blinded randomized controlled trial testing CHW efficacy in improving physiologic outcomes and self-management behaviors among Mexican-Americans with type 2 diabetes. This paper describes methods used to overcome limitations of prior studies. Research Design and Methods The primary aim was to determine if a CHW intervention would result in significant reductions in Hemoglobin A1c and rates of uncontrolled blood pressure. 144 Mexican-Americans with diabetes were randomized. The intervention consisted of self-management training delivered by CHWs over a 24-month period; the comparison population received identical information via bilingual newsletter. Blinded research assistants completed assessments at baseline, 12 months, and 24 months post-randomization. Results The MATCH cohort was characterized by low acculturation and socioeconomic status. Study participants had low rates of medication adherence and glucose monitoring. 70% had poor glycemic control with A1c levels over 7.0, and 57.3% had blood pressures worse than ADA target levels (<130/80). Conclusions MATCH preserved community sensitivity and methodologic rigor. The study’s attention to intervention fidelity, behavioral attention control, blinded outcomes assessment, and strategies to enhance participant retention can be replicated by researchers testing culturally-tailored CHW interventions. PMID:22115970

  2. Use of behavioral economics and social psychology to improve treatment of acute respiratory infections (BEARI): rationale and design of a cluster randomized controlled trial [1RC4AG039115-01]--study protocol and baseline practice and provider characteristics.

    PubMed

    Persell, Stephen D; Friedberg, Mark W; Meeker, Daniella; Linder, Jeffrey A; Fox, Craig R; Goldstein, Noah J; Shah, Parth D; Knight, Tara K; Doctor, Jason N

    2013-06-27

    the provider periodically by email. We enrolled 269 clinicians (practicing attending physicians or advanced practice nurses) in 49 participating clinic sites and collected baseline data. The primary outcome is the antibiotic prescribing rate for office visits with non-antibiotic-appropriate ARI diagnoses. Secondary outcomes will examine antibiotic prescribing more broadly. The 18-month intervention period will be followed by a one year follow-up period to measure persistence of effects after interventions cease. The ongoing BEARI Trial will evaluate the effectiveness of behavioral economic strategies in reducing inappropriate prescribing of antibiotics. ClinicalTrials.gov: NCT01454947.

  3. Baseline Characteristics and Early Response at Week 1 Predict Treatment Outcome in Adolescents With Bipolar Manic or Mixed Episode Treated With Olanzapine: Results From a 3-Week, Randomized, Placebo-Controlled Trial.

    PubMed

    Xiao, Le; Ganocy, Stephen J; Findling, Robert L; Chang, Kiki; DelBello, Melissa P; Kane, John M; Tohen, Mauricio; Xiang, Yu-Tao; Correll, Christoph U

    2017-09-05

    Early predictors of response and remission in pediatric mania are lacking, requiring further study. This was a post hoc analysis of a 3-week, randomized, placebo-controlled trial of olanzapine conducted between November 2002 and May 2005 in 161 adolescents aged 13-17 years who were diagnosed with a DSM-IV acute manic or mixed episode of bipolar I disorder. Data from the olanzapine arm were analyzed to investigate the predictive power of early response or early nonresponse (≥25% or < 25% reduction in Young Mania Rating Scale [YMRS] score, respectively) at week 1 for ultimate response or nonresponse (≥ 50% or < 50% reduction in YMRS score, respectively) and for remission (YMRS total score ≤ 12 [standard definition] or ≤ 8 [stringent definition]) at week 3. Correlates of early response and ultimate response were examined in multivariable regression models. By week 1, 69.2% of olanzapine-treated adolescents (n = 104, 2.5-20.0 mg/d) achieved early response, and 49.0% reached ultimate response at week 3. Patients with early response and early nonresponse were similar regarding baseline variables except higher scores for sleep and thought content were found with early response (P < .05) and higher olanzapine doses with early nonresponse (P < .01). At week 3, early response was associated with significantly greater improvements in YMRS, Clinical Global Impressions-Severity of Illness scale (both P < .001), and Overt Aggression Scale scores (P = .024). Adverse events were similar in patients with early response and early nonresponse, except for higher AIMS scores for patients with early nonresponse (P = .036). Early response significantly predicted ultimate response (OR = 5.61, P < .001; sensitivity = 86.3, specificity = 47.2, positive predictive value = 61.1, negative predictive value = 78.1). Significantly more early response than early nonresponse patients achieved ultimate response (61.1% vs 21.9%, P < .001) and remission defined by YMRS score ≤ 12 (45.8% vs

  4. The effectiveness of medical assistant health coaching for low-income patients with uncontrolled diabetes, hypertension, and hyperlipidemia: protocol for a randomized controlled trial and baseline characteristics of the study population.

    PubMed

    Willard-Grace, Rachel; DeVore, Denise; Chen, Ellen H; Hessler, Danielle; Bodenheimer, Thomas; Thom, David H

    2013-02-23

    Many patients with chronic disease do not reach goals for management of their conditions. Self-management support provided by medical assistant health coaches within the clinical setting may help to improve clinical outcomes, but most studies to date lack statistical power or methodological rigor. Barriers to large scale implementation of the medical assistant coach model include lack of clinician buy-in and the absence of a business model that will make medical assistant health coaching sustainable. This study will add to the evidence base by determining the effectiveness of health coaching by medical assistants on clinical outcomes and patient self-management, by assessing the impact of health coaching on the clinician experience, and by examining the costs and potential savings of health coaching. This randomized controlled trial will evaluate the effectiveness of clinic-based medical assistant health coaches to improve clinical outcomes and self-management skills among low-income patients with uncontrolled type 2 diabetes, hypertension, or hyperlipidemia. A total of 441 patients from two San Francisco primary care clinics have been enrolled and randomized to receive a health coach (n = 224) or usual care (n = 217). Patients participating in the health coaching group will receive coaching for 12 months from medical assistants trained as health coaches. The primary outcome is a change in hemoglobin A1c, systolic blood pressure, or LDL cholesterol among patients with uncontrolled diabetes, hypertension and hyperlipidemia, respectively. Self-management behaviors, perceptions of the health care team and clinician, BMI, and chronic disease self-efficacy will be measured at baseline and after 12 months. Clinician experience is being assessed through surveys and qualitative interviews. Cost and utilization data will be analyzed through cost-predictive models. Medical assistants are an untapped resource to provide self-management support for patients with uncontrolled

  5. Use of behavioral economics and social psychology to improve treatment of acute respiratory infections (BEARI): rationale and design of a cluster randomized controlled trial [1RC4AG039115-01] - study protocol and baseline practice and provider characteristics

    PubMed Central

    2013-01-01

    -performing peers is reported back to the provider periodically by email. We enrolled 269 clinicians (practicing attending physicians or advanced practice nurses) in 49 participating clinic sites and collected baseline data. The primary outcome is the antibiotic prescribing rate for office visits with non-antibiotic-appropriate ARI diagnoses. Secondary outcomes will examine antibiotic prescribing more broadly. The 18-month intervention period will be followed by a one year follow-up period to measure persistence of effects after interventions cease. Discussion The ongoing BEARI Trial will evaluate the effectiveness of behavioral economic strategies in reducing inappropriate prescribing of antibiotics. Trials registration ClinicalTrials.gov: NCT01454947 PMID:23806017

  6. Optical Long Baseline Interferometry News

    NASA Astrophysics Data System (ADS)

    Lawson, P. R.; Malbet, F.

    2005-12-01

    The Optical Long Baseline Interferometry News is a website and forum for scientists, engineers, and students who share an interest in long baseline stellar interferometry. It was established in 1995 and is the focus of activity of the IAU Working Group on Optical/Infrared Interferometry. Here you will find links to projects devoted to stellar interferometry, news items, recent papers and preprints, and resources for further research. The email news forum was established in 2001 to complement the website and to facilitate exchanges and collaborations. The forum includes an email exploder and an archived list of discussions. You are invited to explore the forum and website at http://olbin.jpl.nasa.gov. Work by PRL was carried out at the Jet Propulsion Laboratory, California Institute of Technology, under contract with the National Aeronautics and Space Administration.

  7. Dilution and the elusive baseline.

    PubMed

    Likens, Gene E; Buso, Donald C

    2012-04-17

    Knowledge of baseline conditions is critical for evaluating quantitatively the effect of human activities on environmental conditions, such as the impact of acid deposition. Efforts to restore ecosystems to prior, "pristine" condition require restoration targets, often based on some presumed or unknown baseline condition. Here, we show that rapid and relentless dilution of surface water chemistry is occurring in the White Mountains of New Hampshire, following decades of acid deposition. Extrapolating measured linear trends using a unique data set of up to 47 years, suggest that both precipitation and streamwater chemistry (r(2) >0.84 since 1985) in the Hubbard Brook Experimental Forest (HBEF) will approximate demineralized water within one to three decades. Because such dilute chemistry is unrealistic for surface waters, theoretical baseline compositions have been calculated for precipitation and streamwater: electrical conductivity of 3 and 5 μS/cm, base cation concentrations of 7 and 39 μeq/liter, acid-neutralizing capacity values of <1 and 14 μeq/liter, respectively; and pH 5.5 for both. Significantly large and rapid dilution of surface waters to values even more dilute than proposed for Pre-Industrial Revolution (PIR) conditions has important ecological, biogeochemical and water resource management implications, such as for the success of early reproductive stages of aquatic organisms.

  8. Baseline Graphite Initial Mechanical Test Report

    SciTech Connect

    Mark Carroll; Randy Lloyd

    2009-09-01

    The Next Generation Nuclear Plant (NGNP) Project is tasked with selecting a high temperature gas reactor technology that will be capable of generating electricity and supplying large amounts of process heat. The NGNP is presently being designed as a helium-cooled high temperature gas reactor (HTGR) with a large graphite core. The graphite baseline characterization project is conducting the research and development (R&D) activities deemed necessary to fully qualify nuclear-grade graphite for use in the NGNP reactor. One of the major fundamental objectives of the project is establishing nonirradiated thermomechanical and thermophysical properties by characterizing lot-to-lot and billet-to-billet variations (for probabilistic baseline data needs) through extensive data collection and statistical analysis. The reactor core will be made up of stacks of graphite moderator blocks. In order to gain a more comprehensive understanding of the varying characteristics in a wide range of suitable graphites, any of which can be classified as “nuclear grade,” an experimental program has been initiated to develop an extensive database of the baseline characteristics of numerous candidate graphites. Various factors known to affect the properties of graphite will be investigated, including specimen size, spatial location within a graphite billet, specimen orientation within a billet (either parallel to [P] or transverse to [T] the long axis of the as-produced billet), and billet-to-billet variations within a lot or across different production lots. Because each data point is based on a certain position within a given billet of graphite, particular attention must be paid to the traceability of each specimen and its spatial location and orientation within each billet. The evaluation of these properties is discussed in the Graphite Technology Development Plan (Windes et. al 2007). One of the key components in the evaluation of these graphite types will be mechanical testing of

  9. A 19-SNP coronary heart disease gene score profile in subjects with type 2 diabetes: the coronary heart disease risk in type 2 diabetes (CoRDia study) study baseline characteristics.

    PubMed

    Beaney, Katherine E; Ward, Claire E; Bappa, Dauda A S; McGale, Nadine; Davies, Anna K; Hirani, Shashivadan P; Li, KaWah; Howard, Philip; Vance, Dwaine R; Crockard, Martin A; Lamont, John V; Newman, Stanton; Humphries, Steve E

    2016-10-03

    The coronary risk in diabetes (CoRDia) trial (n = 211) compares the effectiveness of usual diabetes care with a self-management intervention (SMI), with and without personalised risk information (including genetics), on clinical and behavioural outcomes. Here we present an assessment of randomisation, the cardiac risk genotyping assay, and the genetic characteristics of the recruits. Ten-year coronary heart disease (CHD) risk was calculated using the UKPDS score. Genetic CHD risk was determined by genotyping 19 single nucleotide polymorphisms (SNPs) using Randox's Cardiac Risk Prediction Array and calculating a gene score (GS). Accuracy of the array was assessed by genotyping a subset of pre-genotyped samples (n = 185). Overall, 10-year CHD risk ranged from 2-72 % but did not differ between the randomisation groups (p = 0.13). The array results were 99.8 % concordant with the pre-determined genotypes. The GS did not differ between the Caucasian participants in the CoRDia SMI plus risk group (n = 66) (p = 0.80) and a sample of UK healthy men (n = 1360). The GS was also associated with LDL-cholesterol (p = 0.05) and family history (p = 0.03) in a sample of UK healthy men (n = 1360). CHD risk is high in this group of T2D subjects. The risk array is an accurate genotyping assay, and is suitable for estimating an individual's genetic CHD risk. Trial registration This study has been registered at ClinicalTrials.gov; registration identifier NCT01891786.

  10. Baseline LAW Glass Formulation Testing

    SciTech Connect

    Kruger, Albert A.; Mooers, Cavin; Bazemore, Gina; Pegg, Ian L.; Hight, Kenneth; Lai, Shan Tao; Buechele, Andrew; Rielley, Elizabeth; Gan, Hao; Muller, Isabelle S.; Cecil, Richard

    2013-06-13

    The major objective of the baseline glass formulation work was to develop and select glass formulations that are compliant with contractual and processing requirements for each of the LAW waste streams. Other objectives of the work included preparation and characterization of glasses with respect to the properties of interest, optimization of sulfate loading in the glasses, evaluation of ability to achieve waste loading limits, testing to demonstrate compatibility of glass melts with melter materials of construction, development of glass formulations to support ILAW qualification activities, and identification of glass formulation issues with respect to contract specifications and processing requirements.

  11. Orbiter electrical equipment utilization baseline

    NASA Technical Reports Server (NTRS)

    1980-01-01

    The baseline for utilization of Orbiter electrical equipment in both electrical and Environmental Control and Life Support System (ECLSS) thermal analyses is established. It is a composite catalog of Space Shuttle equipment, as defined in the Shuttle Operational Data Book. The major functions and expected usage of each component type are described. Functional descriptions are designed to provide a fundamental understanding of the Orbiter electrical equipment, to insure correlation of equipment usage within nominal analyses, and to aid analysts in the formulation of off-nominal, contingency analyses.

  12. Long-Baseline Neutrino Experiments

    DOE PAGES

    Diwan, M. V.; Galymov, V.; Qian, X.; ...

    2016-10-19

    We review long-baseline neutrino experiments in which neutrinos are detected after traversing macroscopic distances. Over such distances neutrinos have been found to oscillate among flavor states. Experiments with solar, atmospheric, reactor, and accelerator neutrinos have resulted in a coherent picture of neutrino masses and mixing of the three known flavor states. We will summarize the current best knowledge of neutrino parameters and phenomenology with our focus on the evolution of the experimental technique. We will proceed from the rst evidence produced by astrophysical neutrino sources to the current open questions and the goals of future research

  13. Geotaxis baseline data for Drosophila

    NASA Technical Reports Server (NTRS)

    Schnebel, E. M.; Bhargava, R.; Grossfield, J.

    1987-01-01

    Geotaxis profiles for 20 Drosophila species and semispecies at different ages have been examined using a calibrated, adjustable slant board device. Measurements were taken at 5 deg intervals ranging from 0 deg to 85 deg. Clear strain and species differences are observed, with some groups tending to move upward (- geotaxis) with increasing angles, while others move downward (+ geotaxis). Geotactic responses change with age in some, but not all experimental groups. Sample geotaxis profiles are presented and their application to ecological and aging studies are discussed. Data provide a baseline for future evaluations of the biological effects of microgravity.

  14. Environmental Baseline File: National Transportation

    SciTech Connect

    1999-05-22

    This Environmental Baseline File summarizes and consolidates information related to the national-level transportation of commercial spent nuclear fuel. Topics address include: shipmnents of commercial spent nuclear fuel based on mostly truck and mostly rail shipping scenarios; transportation routing for commercial spent nuclear fuel sites and DOE sites; radionuclide inventories for various shipping container capacities; transportation routing; populations along transportation routes; urbanized area population densities; the impacts of historical, reasonably foreseeable, and general transportation; state-level food transfer factors; Federal Guidance Report No. 11 and 12 radionuclide dose conversion factors; and national average atmospheric conditions.

  15. Long-Baseline Neutrino Experiments

    NASA Astrophysics Data System (ADS)

    Diwan, M. V.; Galymov, V.; Qian, X.; Rubbia, A.

    2016-10-01

    We review long-baseline neutrino experiments in which neutrinos are detected after traversing macroscopic distances. Over such distances neutrinos have been found to oscillate among flavor states. Experiments with solar, atmospheric, reactor, and accelerator neutrinos have resulted in a coherent picture of neutrino masses and mixing of the three known flavor states. We summarize the current best knowledge of neutrino parameters and phenomenology, with a focus on the evolution of the experimental technique. We proceed from the first evidence produced by astrophysical neutrino sources to the current open questions and the goals of future research.

  16. Agricultural Baseline (BL0) scenario

    DOE Data Explorer

    Davis, Maggie R. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)] (ORCID:0000000181319328); Hellwinckel, Chad M [University of Tennessee] (ORCID:0000000173085058); Eaton, Laurence [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)] (ORCID:0000000312709626); Turhollow, Anthony [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)] (ORCID:0000000228159350); Brandt, Craig [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)] (ORCID:0000000214707379); Langholtz, Matthew H. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)] (ORCID:0000000281537154)

    2016-07-13

    Scientific reason for data generation: to serve as the reference case for the BT16 volume 1 agricultural scenarios. The agricultural baseline runs from 2015 through 2040; a starting year of 2014 is used. Date the data set was last modified: 02/12/2016 How each parameter was produced (methods), format, and relationship to other data in the data set: simulation was developed without offering a farmgate price to energy crops or residues (i.e., building on both the USDA 2015 baseline and the agricultural census data (USDA NASS 2014). Data generated are .txt output files by year, simulation identifier, county code (1-3109). Instruments used: POLYSYS (version POLYS2015_V10_alt_JAN22B) supplied by the University of Tennessee APAC The quality assurance and quality control that have been applied: • Check for negative planted area, harvested area, production, yield and cost values. • Check if harvested area exceeds planted area for annuals. • Check FIPS codes.

  17. Baseline experiments in teleoperator control

    NASA Technical Reports Server (NTRS)

    Hankins, W. W., III; Mixon, R. W.

    1986-01-01

    Studies have been conducted at the NASA Langley Research Center (LaRC) to establish baseline human teleoperator interface data and to assess the influence of some of the interface parameters on human performance in teleoperation. As baseline data, the results will be used to assess future interface improvements resulting from this research in basic teleoperator human factors. In addition, the data have been used to validate LaRC's basic teleoperator hardware setup and to compare initial teleoperator study results. Four subjects controlled a modified industrial manipulator to perform a simple task involving both high and low precision. Two different schemes for controlling the manipulator were studied along with both direct and indirect viewing of the task. Performance of the task was measured as the length of time required to complete the task along with the number of errors made in the process. Analyses of variance were computed to determine the significance of the influences of each of the independent variables. Comparisons were also made between the LaRC data and data taken earlier by Grumman Aerospace Corp. at their facilities.

  18. Analysis of baseline gene expression levels from ...

    EPA Pesticide Factsheets

    The use of gene expression profiling to predict chemical mode of action would be enhanced by better characterization of variance due to individual, environmental, and technical factors. Meta-analysis of microarray data from untreated or vehicle-treated animals within the control arm of toxicogenomics studies has yielded useful information on baseline fluctuations in gene expression. A dataset of control animal microarray expression data was assembled by a working group of the Health and Environmental Sciences Institute's Technical Committee on the Application of Genomics in Mechanism Based Risk Assessment in order to provide a public resource for assessments of variability in baseline gene expression. Data from over 500 Affymetrix microarrays from control rat liver and kidney were collected from 16 different institutions. Thirty-five biological and technical factors were obtained for each animal, describing a wide range of study characteristics, and a subset were evaluated in detail for their contribution to total variability using multivariate statistical and graphical techniques. The study factors that emerged as key sources of variability included gender, organ section, strain, and fasting state. These and other study factors were identified as key descriptors that should be included in the minimal information about a toxicogenomics study needed for interpretation of results by an independent source. Genes that are the most and least variable, gender-selectiv

  19. In-Space Manufacturing Baseline Property Development

    NASA Technical Reports Server (NTRS)

    Stockman, Tom; Schneider, Judith; Prater, Tracie; Bean, Quincy; Werkheiser, Nicki

    2016-01-01

    The In-Space Manufacturing (ISM) project at NASA Marshall Space Flight Center currently operates a 3D FDM (fused deposition modeling) printer onboard the International Space Station. In order to enable utilization of this capability by designer, the project needs to establish characteristic material properties for materials produced using the process. This is difficult for additive manufacturing since standards and specifications do not yet exist for these technologies. Due to availability of crew time, there are limitations to the sample size which in turn limits the application of the traditional design allowables approaches to develop a materials property database for designers. In this study, various approaches to development of material databases were evaluated for use by designers of space systems who wish to leverage in-space manufacturing capabilities. This study focuses on alternative statistical techniques for baseline property development to support in-space manufacturing.

  20. Integrated Baseline Review (IBR) Handbook

    NASA Technical Reports Server (NTRS)

    Fleming, Jon F.; Kehrer, Kristen C.

    2016-01-01

    The purpose of this handbook is intended to be a how-to guide to prepare for, conduct, and close-out an Integrated Baseline Review (IBR). It discusses the steps that should be considered, describes roles and responsibilities, tips for tailoring the IBR based on risk, cost, and need for management insight, and provides lessons learned from past IBRs. Appendices contain example documentation typically used in connection with an IBR. Note that these appendices are examples only, and should be tailored to meet the needs of individual projects and contracts. Following the guidance in this handbook will help customers and suppliers preparing for an IBR understand the expectations of the IBR, and ensure that the IBR meets the requirements for both in-house and contract efforts.

  1. Pinellas Plant Environmental Baseline Report

    SciTech Connect

    Not Available

    1997-06-01

    The Pinellas Plant has been part of the Department of Energy`s (DOE) nuclear weapons complex since the plant opened in 1957. In March 1995, the DOE sold the Pinellas Plant to the Pinellas County Industry Council (PCIC). DOE has leased back a large portion of the plant site to facilitate transition to alternate use and safe shutdown. The current mission is to achieve a safe transition of the facility from defense production and prepare the site for alternative uses as a community resource for economic development. Toward that effort, the Pinellas Plant Environmental Baseline Report (EBR) discusses the current and past environmental conditions of the plant site. Information for the EBR is obtained from plant records. Historical process and chemical usage information for each area is reviewed during area characterizations.

  2. Baseline characteristics of different strata of astronaut corps

    NASA Technical Reports Server (NTRS)

    Hamm, Peggy B.; Pepper, L. J.

    1993-01-01

    The Longitudinal Study of Astronaut Health (LSAH) is an epidemiological study designed to study the effects of the occupational exposures incurred by astronauts in health outcomes and changes in physiological variables. Between 1959 and 1991, 195 individuals were selected for the program. The medical standards for selection have remained essentially unchanged since the Mercury Program, but the range and stringency of these criteria have been modified. Demographic and physiological variables identified during the selection year are examined for various strata of the Astronaut Corps. Specifically, age, sex, race, education, usual occupation, military affiliation, medical history, family medical history, visual and hearing measurements, physical exam variables, and specific laboratory values are investigated. Differences are examined in astronauts for the following criteria: (1) were selected prior to 1970 (n = 73) versus those selected after 1970 (n = 122); (2) have flown multiple missions versus those who have flown less than two missions; (3) have walked in space versus all others; (4) have more than 500 hours of mission time versus all others; and (5) have gone to the Moon versus all others. Length of time served in the Astronaut Corps is examined for each of these strata.

  3. Baseline Characteristics of the Korean Registry of Pulmonary Arterial Hypertension.

    PubMed

    Chung, Wook-Jin; Park, Yong Bum; Jeon, Chan Hong; Jung, Jo Won; Ko, Kwang-Phil; Choi, Sung Jae; Seo, Hye Sun; Lee, Jae Seung; Jung, Hae Ok

    2015-10-01

    Despite recent advances in understanding of the pathobiology and targeted treatments of pulmonary arterial hypertension (PAH), epidemiologic data from large populations have been limited to western countries. The aim of the Korean Registry of Pulmonary Arterial Hypertension (KORPAH) was to examine the epidemiology and prognosis of Korean patients with PAH. KORPAH was designed as a nationwide, multicenter, prospective data collection using an internet webserver from September 2008 to December 2011. A total of 625 patients were enrolled. The patients' mean age was 47.6 ± 15.7 yr, and 503 (80.5%) were women. The diagnostic methods included right heart catheterization (n = 249, 39.8%) and Doppler echocardiography (n = 376, 60.2%). The etiologies, in order of frequency, were connective tissue disease (CTD), congenital heart disease, and idiopathic PAH (IPAH) (49.8%, 25.4%, and 23.2%, respectively). Patients with WHO functional class III or IV at diagnosis were 43.4%. In total, 380 (60.8%) patients received a single PAH-specific treatment at the time of enrollment, but only 72 (18.9%) patients received combination therapy. Incident cases during the registry represented 297 patients; therefore, the incidence rate of PAH was 1.9 patients/yr/million people. The 1st-, 2nd-, and 3rd-yr estimated survival rates were 90.8%, 87.8%, and 84.4%, respectively. Although Korean PAH patients exhibited similar age, gender, and survival rate compared with western registries, they showed relatively more CTD-PAH in the etiology and also systemic lupus erythematosus among CTD-PAH. The data suggest that earlier diagnosis and more specialized therapies should be needed to improve the survival of PAH patients.

  4. How to deal with cost differences at baseline.

    PubMed

    van Asselt, Antoinette D I; van Mastrigt, Ghislaine A P G; Dirksen, Carmen D; Arntz, Arnoud; Severens, Johan L; Kessels, Alfons G H

    2009-01-01

    To our knowledge, adjustment for baseline imbalances in costs has never been performed in trial-based cost-effectiveness analyses. We used data from a clinical trial performed in the Netherlands comparing two outpatient psychotherapies: schema-focused therapy (SFT) versus transference-focused psychotherapy (TFP). Costs were assessed with a cost interview. Outcome was the proportion of recovered patients measured with the Borderline Personality Disorder Severity Index (BPDSI-IV). We used three methods to adjust the costs for baseline differences: (i) mean difference adjustment, calculating total costs after baseline by adjusting the difference between groups with the difference of the mean baseline costs; (ii) delta adjustment, calculating the individual differences between patient baseline and the subsequent measurements (concerning incremental costs, this is the same as mean difference adjustment); and (iii) regression-based adjustment, adjusting total costs with a regression model, with total costs as the dependent variable and baseline costs as the independent variable. Mean baseline costs were 3339 euros for SFT and 4238 euros for TFP, a mean difference of 899 euros. Total unadjusted follow-up costs were 30822 euros for SFT and 36812 euros for TFP. The fraction of recovered patients was 45% for SFT and 24% for TFP. Cost-effectiveness acceptability curves show that mean difference and delta adjustments are different from the regression-based methods. Although the routine starting point of an analysis should always be an unadjusted analysis of the cost effectiveness, a baseline difference between treatment groups should be adjusted for. This should be done by reported patient characteristics or, when these are not sufficiently present, by baseline costs as a substitute. This adjustment should be carried out most preferably with a regression-based method.

  5. Baseline Graphite Characterization: First Billet

    SciTech Connect

    Mark C. Carroll; Joe Lords; David Rohrbaugh

    2010-09-01

    The Next Generation Nuclear Plant Project Graphite Research and Development program is currently establishing the safe operating envelope of graphite core components for a very high temperature reactor design. To meet this goal, the program is generating the extensive amount of quantitative data necessary for predicting the behavior and operating performance of the available nuclear graphite grades. In order determine the in-service behavior of the graphite for the latest proposed designs, two main programs are underway. The first, the Advanced Graphite Creep (AGC) program, is a set of experiments that are designed to evaluate the irradiated properties and behavior of nuclear grade graphite over a large spectrum of temperatures, neutron fluences, and compressive loads. Despite the aggressive experimental matrix that comprises the set of AGC test runs, a limited amount of data can be generated based upon the availability of space within the Advanced Test Reactor and the geometric constraints placed on the AGC specimens that will be inserted. In order to supplement the AGC data set, the Baseline Graphite Characterization program will endeavor to provide supplemental data that will characterize the inherent property variability in nuclear-grade graphite without the testing constraints of the AGC program. This variability in properties is a natural artifact of graphite due to the geologic raw materials that are utilized in its production. This variability will be quantified not only within a single billet of as-produced graphite, but also from billets within a single lot, billets from different lots of the same grade, and across different billets of the numerous grades of nuclear graphite that are presently available. The thorough understanding of this variability will provide added detail to the irradiated property data, and provide a more thorough understanding of the behavior of graphite that will be used in reactor design and licensing. This report covers the

  6. SUGV baseline autonomy using ROS

    NASA Astrophysics Data System (ADS)

    Stump, Ethan; Sadler, Laurel; Baran, David

    2011-05-01

    Currently, the 3000+ robotic systems fielded in theater are entirely teleoperated. This constant dependence on operator control introduces several problems, including a large cognitive load on the operator and a limited ability for the operator to maintain an appropriate level of situational awareness of his surroundings. One solution to reduce the dependence on teleoperation is to develop autonomous behaviors for the robot to reduce the strain on the operator. We consider mapping and navigation to be fundamental to the development of useful field autonomy for small unmanned ground vehicles (SUGVs). To this end, we have developed baseline autonomous capabilities for our SUGV platforms, making use of the open-source Robot Operating System (ROS) software from Willow Garage, Inc. Their implementations of mapping and navigation are drawn from the most successful published academic algorithms in robotics. In this paper, we describe how we bridged our previous work with the Packbot Explorer to incorporate a new processing payload, new sensors, and the ROS system configured to perform the high-level autonomy tasks of mapping and waypoint navigation. We document our most successful parameter selection for the ROS navigation software in an indoor environment and present results of a mapping experiment.

  7. Shifting Baselines, Science, and Society

    NASA Astrophysics Data System (ADS)

    Jackson, J. B.

    2006-12-01

    All of us have a deeply personal concept of nature based upon our childhood perceptions of the world around us, and of the subsequent degradation of nature by the experiences of our lifetimes. Yet even the most rudimentary knowledge of history clearly demonstrates that the modern rise of human population and consumption have wreaked havoc on global ecosystems to the extent that nowhere is close to natural or pristine and that most places have been increasingly degraded over many centuries. This disconnect between direct personal experience and abstract historical perspective is the problem of "shifting baselines" that is the fundamental impediment to basic scientific understanding and environmental policy, and affects scientists as much as the general public, business, and government. Scientists in particular suffer from the inability to directly observe and experimentally verify causes and effects of previous changes in ecosystems that now bear so little resemblance to their natural state. Under the circumstances, it is essential for scientists to draw scientific conclusions based on imperfect data and to publicly explain, defend, and discuss their conclusions as the best possible science given present information. The failure to do so makes science virtually irrelevant to social and environmental policy and government.

  8. 2016 Annual Technology Baseline (ATB)

    SciTech Connect

    Cole, Wesley; Kurup, Parthiv; Hand, Maureen; Feldman, David; Sigrin, Benjamin; Lantz, Eric; Stehly, Tyler; Augustine, Chad; Turchi, Craig; O'Connor, Patrick; Waldoch, Connor

    2016-09-01

    Consistent cost and performance data for various electricity generation technologies can be difficult to find and may change frequently for certain technologies. With the Annual Technology Baseline (ATB), National Renewable Energy Laboratory provides an organized and centralized dataset that was reviewed by internal and external experts. It uses the best information from the Department of Energy laboratory's renewable energy analysts and Energy Information Administration information for conventional technologies. The ATB will be updated annually in order to provide an up-to-date repository of current and future cost and performance data. Going forward, we plan to revise and refine the values using best available information. The ATB includes both a presentation with notes (PDF) and an associated Excel Workbook. The ATB includes the following electricity generation technologies: land-based wind; offshore wind; utility-scale solar PV; concentrating solar power; geothermal power; hydropower plants (upgrades to existing facilities, powering non-powered dams, and new stream-reach development); conventional coal; coal with carbon capture and sequestration; integrated gasification combined cycle coal; natural gas combustion turbines; natural gas combined cycle; conventional biopower. Nuclear laboratory's renewable energy analysts and Energy Information Administration information for conventional technologies. The ATB will be updated annually in order to provide an up-to-date repository of current and future cost and performance data. Going forward, we plan to revise and refine the values using best available information.

  9. Space Station-Baseline Configuration

    NASA Technical Reports Server (NTRS)

    1989-01-01

    In response to President Reagan's directive to NASA to develop a permanent marned Space Station within a decade, part of the State of the Union message to Congress on January 25, 1984, NASA and the Administration adopted a phased approach to Station development. This approach provided an initial capability at reduced costs, to be followed by an enhanced Space Station capability in the future. This illustration depicts the baseline configuration, which features a 110-meter-long horizontal boom with four pressurized modules attached in the middle. Located at each end are four photovoltaic arrays generating a total of 75-kW of power. Two attachment points for external payloads are provided along this boom. The four pressurized modules include the following: A laboratory and habitation module provided by the United States; two additional laboratories, one each provided by the European Space Agency (ESA) and Japan; and an ESA-provided Man-Tended Free Flyer, a pressurized module capable of operations both attached to and separate from the Space Station core. Canada was expected to provide the first increment of a Mobile Serving System.

  10. Light duty utility arm baseline system description

    SciTech Connect

    Kiebel, G.R.

    1996-02-01

    This document describes the configuration of the Light Duty Utility Arm (LDUA) Baseline System. The baseline system is the initial configuration of the LDUA system that will be qualified for hot deployment in Hanford single shell underground storage tanks.

  11. 2016 Annual Technology Baseline (ATB) - Webinar Presentation

    SciTech Connect

    Cole, Wesley; Kurup, Parthiv; Hand, Maureen; Feldman, David; Sigrin, Benjamin; Lantz, Eric; Stehly, Tyler; Augustine, Chad; Turchi, Craig; Porro, Gian; O'Connor, Patrick; Waldoch, Connor

    2016-09-13

    This deck was presented for the 2016 Annual Technology Baseline Webinar. The presentation describes the Annual Technology Baseline, which is a compilation of current and future cost and performance data for electricity generation technologies.

  12. Statistical testing against baseline was common in dental research.

    PubMed

    Koletsi, Despina; Madahar, Arun; Fleming, Padhraig S; Pandis, Nikolaos

    2015-07-01

    To assess the presence of within-group comparisons with baseline in a subset of leading dental journals and to explore possible associations with a range of study characteristics including journal and study design. Thirty consecutive issues of five leading dental journals were electronically searched. The conduct and reporting of statistical analysis in respect of comparisons against baseline or otherwise along with the manner of interpretation of the results were assessed. Descriptive statistics were obtained, and chi-square test and Fisher's exact were undertaken to test the association between trial characteristics and overall study interpretation. A total of 184 studies were included with the highest proportion published in Journal of Endodontics (n = 84, 46%) and most involving a single center (n = 157, 85%). Overall, 43 studies (23%) presented interpretation of their outcomes based solely on comparisons against baseline. Inappropriate use of baseline testing was found to be less likely in interventional studies (P < 0.001). Use of comparisons with baseline appears to be common among both observational and interventional research studies in dentistry. Enhanced conduct and reporting of statistical tests are required to ensure that inferences from research studies are appropriate and informative. Copyright © 2015 Elsevier Inc. All rights reserved.

  13. Shuttle mission simulator baseline definition report, volume 1

    NASA Technical Reports Server (NTRS)

    Burke, J. F.; Small, D. E.

    1973-01-01

    A baseline definition of the space shuttle mission simulator is presented. The subjects discussed are: (1) physical arrangement of the complete simulator system in the appropriate facility, with a definition of the required facility modifications, (2) functional descriptions of all hardware units, including the operational features, data demands, and facility interfaces, (3) hardware features necessary to integrate the items into a baseline simulator system to include the rationale for selecting the chosen implementation, and (4) operating, maintenance, and configuration updating characteristics of the simulator hardware.

  14. Lung VITAL: Rationale, design, and baseline characteristics of an ancillary study evaluating the effects of vitamin D and/or marine omega-3 fatty acid supplements on acute exacerbations of chronic respiratory disease, asthma control, pneumonia and lung function in adults.

    PubMed

    Gold, Diane R; Litonjua, Augusto A; Carey, Vincent J; Manson, JoAnn E; Buring, Julie E; Lee, I-Min; Gordon, David; Walter, Joseph; Friedenberg, Georgina; Hankinson, John L; Copeland, Trisha; Luttmann-Gibson, Heike

    2016-03-01

    Laboratory and observational research studies suggest that vitamin D and marine omega-3 fatty acids may reduce risk for pneumonia, acute exacerbations of respiratory diseases including chronic obstructive lung disease (COPD) or asthma, and decline of lung function, but prevention trials with adequate dosing, adequate power, and adequate time to follow-up are lacking. The ongoing Lung VITAL study is taking advantage of a large clinical trial-the VITamin D and OmegA-3 TriaL (VITAL)--to conduct the first major evaluation of the influences of vitamin D and marine omega-3 fatty acid supplementation on pneumonia risk, respiratory exacerbation episodes, asthma control and lung function in adults. VITAL is a 5-year U.S.-wide randomized, double-blind, placebo-controlled, 2 × 2 factorial trial of supplementation with vitamin D3 ([cholecalciferol], 2000 IU/day) and marine omega-3 FA (Omacor® fish oil, eicosapentaenoic acid [EPA]+docosahexaenoic acid [DHA], 1g/day) for primary prevention of CVD and cancer among men and women, at baseline aged ≥50 and ≥55, respectively, with 5107 African Americans. In a subset of 1973 participants from 11 urban U.S. centers, lung function is measured before and two years after randomization. Yearly follow-up questionnaires assess incident pneumonia in the entire randomized population, and exacerbations of respiratory disease, asthma control and dyspnea in a subpopulation of 4314 randomized participants enriched, as shown in presentation of baseline characteristics, for respiratory disease, respiratory symptoms, and history of cigarette smoking. Self-reported pneumonia hospitalization will be confirmed by medical record review, and exacerbations will be confirmed by Center for Medicare and Medicaid Services data review. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Lung VITAL: Rationale, design, and baseline characteristics of an ancillary study evaluating the effects of vitamin D and/or marine omega-3 fatty acid supplements on acute exacerbations of chronic respiratory disease, asthma control, pneumonia and lung function in adults

    PubMed Central

    Gold, Diane R; Litonjua, Augusto A.; Carey, Vincent J.; Manson, JoAnn E.; Buring, Julie E; Lee, I-Min; Gordon, David; Walter, Joseph; Friedenberg, Georgina; Hankinson, John L; Copeland, Trisha; Luttmann-Gibson, Heike

    2016-01-01

    Laboratory and observational research studies suggest that vitamin D and marine omega-3 fatty acids may reduce risk for pneumonia, acute exacerbations of respiratory diseases including chronic obstructive lung disease (COPD) or asthma, and decline of lung function, but prevention trials with adequate dosing, adequate power, and adequate time to follow-up are lacking. The ongoing Lung VITAL study is taking advantage of a large clinical trial—the VITamin D and OmegA-3 TriaL (VITAL)—to conduct the first major evaluation of the influences of vitamin D and marine omega-3 fatty acid supplementation on pneumonia risk, respiratory exacerbation episodes, asthma control and lung function in adults. VITAL is a 5-year U.S.-wide randomized, double-blind, placebo-controlled, 2×2 factorial trial of supplementation with vitamin D3 ([cholecalciferol], 2000 IU/day) and marine omega-3 FA (Omacor® fish oil, eicosapentaenoic acid [EPA] +docosahexaenoic acid [DHA], 1 g/day) for primary prevention of CVD and cancer among men and women, at baseline aged ≥50 and ≥55, respectively, with 5107 African Americans. In a subset of 1973 participants from 11 urban U.S. centers, lung function is measured before and two years after randomization. Yearly follow-up questionnaires assess incident pneumonia in the entire randomized population, and exacerbations of respiratory disease, asthma control and dyspnea in a subpopulation of 4314 randomized participants enriched, as shown in presentation of baseline characteristics, for respiratory disease, respiratory symptoms, and history of cigarette smoking. Self-reported pneumonia hospitalization will be confirmed by medical record review, and exacerbations will be confirmed by Center for Medicare and Medicaid Services data review. PMID:26784651

  16. Precision surveying using very long baseline interferometry

    NASA Technical Reports Server (NTRS)

    Ryan, J. W.; Clark, T. A.; Coates, R.; Ma, C.; Robertson, D. S.; Corey, B. E.; Counselman, C. C.; Shapiro, I. I.; Wittels, J. J.; Hinteregger, H. F.

    1977-01-01

    Radio interferometry measurements were used to measure the vector baselines between large microwave radio antennas. A 1.24 km baseline in Massachusetts between the 36 meter Haystack Observatory antenna and the 18 meter Westford antenna of Lincoln Laboratory was measured with 5 mm repeatability in 12 separate experiments. Preliminary results from measurements of the 3,928 km baseline between the Haystack antenna and the 40 meter antenna at the Owens Valley Radio Observatory in California are presented.

  17. Behind the (impedance) baseline in children.

    PubMed

    Salvatore, S; Salvatoni, A; Van Steen, K; Ummarino, D; Hauser, B; Vandenplas, Y

    2014-01-01

    Impedance baseline is a new parameter recently related to esophageal integrity. The aim of this study was to assess the effect of different factors on impedance baseline in pediatric patients. We analyzed the impedance baseline of 800 children with symptoms of gastroesophageal reflux. Mean impedance baseline was automatically calculated throughout 24-hour tracings. The presence of different age groups and of esophagitis was evaluated. Unpaired t-test, Spearman rank correlation, polynomial, and regression plot were used for statistical analysis. Age-related percentile curves were created. We considered a P-value<0.05 as statistically significant. Impedance baseline was significantly (P<0.001) lower in younger compared to older children up to 48 months. The mean increase of baseline per month was much higher in the first 36 months of life (47.5 vs. 2.9 Ohm in Channel 1 and 29.9 vs. 2.3 Ohm in Channel 6, respectively) than in older ages. Patients with esophagitis showed significantly decreased impedance baseline (P<0.05). Infants (especially in the first months of life) and young children present a significantly lower impedance baseline compared to older children both in proximal and distal esophagus. The presence of esophagitis may also determine a decreased impedance baseline regardless of the age of the patients.

  18. Design of experiment for earth rotation and baseline parameter determination from very long baseline interferometry

    NASA Technical Reports Server (NTRS)

    Dermanis, A.

    1977-01-01

    The possibility of recovering earth rotation and network geometry (baseline) parameters are emphasized. The numerical simulated experiments performed are set up in an environment where station coordinates vary with respect to inertial space according to a simulated earth rotation model similar to the actual but unknown rotation of the earth. The basic technique of VLBI and its mathematical model are presented. The parametrization of earth rotation chosen is described and the resulting model is linearized. A simple analysis of the geometry of the observations leads to some useful hints on achieving maximum sensitivity of the observations with respect to the parameters considered. The basic philosophy for the simulation of data and their analysis through standard least squares adjustment techniques is presented. A number of characteristic network designs based on present and candidate station locations are chosen. The results of the simulations for each design are presented together with a summary of the conclusions.

  19. Baseline correction of intraoperative electromyography using discrete wavelet transform.

    PubMed

    Rampp, Stefan; Prell, Julian; Thielemann, Henning; Posch, Stefan; Strauss, Christian; Romstöck, Johann

    2007-08-01

    In intraoperative analysis of electromygraphic signals (EMG) for monitoring purposes, baseline artefacts frequently pose considerable problems. Since artefact sources in the operating room can only be reduced to a limited degree, signal-processing methods are needed to correct the registered data online without major changes to the relevant data itself. We describe a method for baseline correction based on "discrete wavelet transform" (DWT) and evaluate its performance compared to commonly used digital filters. EMG data from 10 patients who underwent removal of acoustic neuromas were processed. Effectiveness, preservation of relevant EMG patterns and processing speed of a DWT based correction method was assessed and compared to a range of commonly used Butterworth, Resistor-Capacitor and Gaussian filters. Butterworth and DWT filters showed better performance regarding artefact correction and pattern preservation compared to Resistor-Capacitor and Gaussian filters. Assuming equal weighting of both characteristics, DWT outperformed the other methods: While Butterworth, Resistor-Capacitor and Gaussian provided good pattern preservation, the effectiveness was low and vice versa, while DWT baseline correction at level 6 performed well in both characteristics. The DWT method allows reliable and efficient intraoperative baseline correction in real-time. It is superior to commonly used methods and may be crucial for intraoperative analysis of EMG data, for example for intraoperative assessment of facial nerve function.

  20. TAPIR--Finnish national geochemical baseline database.

    PubMed

    Jarva, Jaana; Tarvainen, Timo; Reinikainen, Jussi; Eklund, Mikael

    2010-09-15

    In Finland, a Government Decree on the Assessment of Soil Contamination and Remediation Needs has generated a need for reliable and readily accessible data on geochemical baseline concentrations in Finnish soils. According to the Decree, baseline concentrations, referring both to the natural geological background concentrations and the diffuse anthropogenic input of substances, shall be taken into account in the soil contamination assessment process. This baseline information is provided in a national geochemical baseline database, TAPIR, that is publicly available via the Internet. Geochemical provinces with elevated baseline concentrations were delineated to provide regional geochemical baseline values. The nationwide geochemical datasets were used to divide Finland into geochemical provinces. Several metals (Co, Cr, Cu, Ni, V, and Zn) showed anomalous concentrations in seven regions that were defined as metal provinces. Arsenic did not follow a similar distribution to any other elements, and four arsenic provinces were separately determined. Nationwide geochemical datasets were not available for some other important elements such as Cd and Pb. Although these elements are included in the TAPIR system, their distribution does not necessarily follow the ones pre-defined for metal and arsenic provinces. Regional geochemical baseline values, presented as upper limit of geochemical variation within the region, can be used as trigger values to assess potential soil contamination. Baseline values have also been used to determine upper and lower guideline values that must be taken into account as a tool in basic risk assessment. If regional geochemical baseline values are available, the national guideline values prescribed in the Decree based on ecological risks can be modified accordingly. The national geochemical baseline database provides scientifically sound, easily accessible and generally accepted information on the baseline values, and it can be used in various

  1. The importance of archiving baseline wilderness data

    Treesearch

    David N. Cole

    2007-01-01

    Baseline wilderness data are of considerable importance for several reasons. One of the primary values of wilderness is as a reference that contrasts with those lands where humans dominate the landscape. Leopold (1941) called wilderness "a base-datum of normality, a picture of how healthy land maintains itself." To realize this value, baseline data on...

  2. The Very-Long-Baseline Array.

    ERIC Educational Resources Information Center

    Kellermann, Kenneth I.; Thompson, A. Richard

    1988-01-01

    Describes the very-long-baseline array (VLBA) system of radio telescopes that will be completed in the early 1990s. Explains how the VLBA system works and the advantages over present technology. Compares associated international telescopes and very-long-baseline interferometers (VLBI). Illustrates applications for the VLBA and VLBI. (CW)

  3. 40 CFR 1042.825 - Baseline determination.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... CONTROLS CONTROL OF EMISSIONS FROM NEW AND IN-USE MARINE COMPRESSION-IGNITION ENGINES AND VESSELS Special... adjust it differently, consistent with good engineering judgment. (d) Test the baseline engine four times according to the test procedures in subpart F of this part. The baseline emissions are the average of those...

  4. Longer-baseline telescopes using quantum repeaters.

    PubMed

    Gottesman, Daniel; Jennewein, Thomas; Croke, Sarah

    2012-08-17

    We present an approach to building interferometric telescopes using ideas of quantum information. Current optical interferometers have limited baseline lengths, and thus limited resolution, because of noise and loss of signal due to the transmission of photons between the telescopes. The technology of quantum repeaters has the potential to eliminate this limit, allowing in principle interferometers with arbitrarily long baselines.

  5. Error estimation for ORION baseline vector determination

    NASA Technical Reports Server (NTRS)

    Wu, S. C.

    1980-01-01

    Effects of error sources on Operational Radio Interferometry Observing Network (ORION) baseline vector determination are studied. Partial derivatives of delay observations with respect to each error source are formulated. Covariance analysis is performed to estimate the contribution of each error source to baseline vector error. System design parameters such as antenna sizes, system temperatures and provision for dual frequency operation are discussed.

  6. Multi-Baseline Stereo Using Surface Extraction.

    DTIC Science & Technology

    1996-11-24

    Nakahara, T. and Kanade, T. "Experiments in Multiple - Baseline Stereo" CMU-CS-93-102. 28 [16] Nakamura, Y., Matsuura, T., Satoh, K. and Ohta...of Computer Vision, 7:2, 1992:p. 143-162. [19] Okutomi, M. and Kanade, T. "A Multiple - Baseline Stereo" IEEE Trans, on PAMI, 1993. 15(4):p. 353-63

  7. The Very-Long-Baseline Array.

    ERIC Educational Resources Information Center

    Kellermann, Kenneth I.; Thompson, A. Richard

    1988-01-01

    Describes the very-long-baseline array (VLBA) system of radio telescopes that will be completed in the early 1990s. Explains how the VLBA system works and the advantages over present technology. Compares associated international telescopes and very-long-baseline interferometers (VLBI). Illustrates applications for the VLBA and VLBI. (CW)

  8. The role of niacin in raising high-density lipoprotein cholesterol to reduce cardiovascular events in patients with atherosclerotic cardiovascular disease and optimally treated low-density lipoprotein cholesterol: baseline characteristics of study participants. The Atherothrombosis Intervention in Metabolic syndrome with low HDL/high triglycerides: impact on Global Health outcomes (AIM-HIGH) trial.

    PubMed

    2011-03-01

    The study aims to report the baseline characteristics of the fully randomized AIM-HIGH study population. Residual risk persists despite aggressive low-density lipoprotein cholesterol (LDL-C) reduction in patients with atherosclerotic cardiovascular (CV) disease, many of whom have atherogenic dyslipidemia (low levels of high-density lipoprotein cholesterol (HDL-C), elevated triglycerides, and small dense LDL particles). All study participants had established CV disease and atherogenic dyslipidemia. Participants received simvastatin (or simvastatin plus ezetimibe) at a dose sufficient to maintain LDL-C at 40 - 80 mg/dL (1.03-2.07 mmol/L) and were randomized to receive extended-release niacin or matching placebo. The primary end point is time to the first occurrence of coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization with average follow-up of 4.1 years. Between 2006 and 2010, 8,162 individuals signed consent to be screened, 4,275 began study drug run-in, and 3,414 were randomized to treatment. Mean age at entry was 64 ± 9 years, 85% were men, and 92% were white. As expected, risk factors were prevalent with 34% having diabetes; 71%, hypertension; and 81%, metabolic syndrome. Most participants had coronary artery disease (92%), whereas 11% had peripheral arterial disease; and 12%, cerebrovascular disease. Previous coronary revascularization occurred in 82%, and 54% reported a prior myocardial infarction. Among participants on a statin at entry (94%), mean baseline LDL-C was 71 mg/dL (1.84 mmol/L); mean HDL-C, 34.9 mg/dL (0.90 mmol/L); and median triglycerides, 161 mg/dL (1.82 mmol/L). AIM-HIGH enrolled a high-risk group of patients with established atherosclerotic CV disease and atherogenic dyslipidemia. This study should determine whether there is incremental clinical benefit of niacin in reducing cardiovascular events in patients who

  9. Baseline Caries Risk Assessment as a Predictor of Caries Incidence

    PubMed Central

    Chaffee, Benjamin W.; Cheng, Jing; Featherstone, John D. B.

    2015-01-01

    Few studies have evaluated clinical outcomes following caries risk assessment in large datasets that reflect risk assessments performed during routine practice. OBJECTIVE From clinical records, compare 18-month caries incidence according to baseline caries risk designation. METHODS For this retrospective cohort study, data were collected from electronic records of non-edentulous adult patients who completed an oral examination and caries risk assessment (CRA) at a university instructional clinic from 2007 to 2012 (N=18,004 baseline patients). The prim