WorldWideScience

Sample records for andalusian multicenter cohort

  1. Riyadh Mother and Baby Multicenter Cohort Study: The Cohort Profile

    Science.gov (United States)

    Esmaeil, Samia; Alzeidan, Rasmieh; Elawad, Mamoun; Tabassum, Rabeena; Hansoti, Shehnaz; Magzoup, Mohie Edein; Al-Kadri, Hanan; Elsherif, Elham; Al-Mandil, Hazim; Al-Shaikh, Ghadeer; Zakaria, Nasria

    2016-01-01

    Objectives To assess the effects of non-communicable diseases, such as diabetes, hypertension and obesity, on the mother and the infant. Methods A multicentre cohort study was conducted in three hospitals in the city of Riyadh in Saudi Arabia. All Saudi women and their babies who delivered in participating hospitals were eligible for recruitment. Data on socio-demographic characteristics in addition to the maternal and neonatal outcomes of pregnancy were collected. The cohort demographic profile was recorded and the prevalence of maternal conditions including gestational diabetes, pre-gestational diabetes, hypertensive disorders in pregnancy and obesity were estimated. Findings The total number of women who delivered in participating hospitals during the study period was 16,012 of which 14,568 women participated in the study. The mean age of the participants was 29 ± 5.9 years and over 40% were university graduates. Most of the participants were housewives, 70% were high or middle income and 22% were exposed to secondhand smoke. Of the total cohort, 24% were married to a first cousin. More than 68% of the participants were either overweight or obese. The preterm delivery rate was 9%, while 1.5% of the deliveries were postdate. The stillbirth rate was 13/1000 live birth. The prevalence of gestational diabetes was 24% and that of pre-gestational diabetes was 4.3%. The preeclampsia prevalence was 1.1%. The labour induction rate was 15.5% and the cesarean section rate was 25%. Conclusion Pregnant women in Saudi Arabia have a unique demographic profile. The prevalence of obesity and diabetes in pregnancy are among the highest in the world. PMID:26937965

  2. Riyadh Mother and Baby Multicenter Cohort Study: The Cohort Profile.

    Directory of Open Access Journals (Sweden)

    Hayfaa Wahabi

    Full Text Available To assess the effects of non-communicable diseases, such as diabetes, hypertension and obesity, on the mother and the infant.A multicentre cohort study was conducted in three hospitals in the city of Riyadh in Saudi Arabia. All Saudi women and their babies who delivered in participating hospitals were eligible for recruitment. Data on socio-demographic characteristics in addition to the maternal and neonatal outcomes of pregnancy were collected. The cohort demographic profile was recorded and the prevalence of maternal conditions including gestational diabetes, pre-gestational diabetes, hypertensive disorders in pregnancy and obesity were estimated.The total number of women who delivered in participating hospitals during the study period was 16,012 of which 14,568 women participated in the study. The mean age of the participants was 29 ± 5.9 years and over 40% were university graduates. Most of the participants were housewives, 70% were high or middle income and 22% were exposed to secondhand smoke. Of the total cohort, 24% were married to a first cousin. More than 68% of the participants were either overweight or obese. The preterm delivery rate was 9%, while 1.5% of the deliveries were postdate. The stillbirth rate was 13/1000 live birth. The prevalence of gestational diabetes was 24% and that of pre-gestational diabetes was 4.3%. The preeclampsia prevalence was 1.1%. The labour induction rate was 15.5% and the cesarean section rate was 25%.Pregnant women in Saudi Arabia have a unique demographic profile. The prevalence of obesity and diabetes in pregnancy are among the highest in the world.

  3. Virologic Response to Lopinavir-Ritonavir-Based Antiretroviral Regimens in a Multicenter International Clinical Cohort: Comparison of Genotypic Interpretation Scores▿

    OpenAIRE

    Grant, Philip; Eric C Wong; Rode, Richard; Shafer, Robert; De Luca, Andrea; Nadler, Jeffrey; Hawkins, Trevor; Cohen, Calvin; Harrington, Robert; Kempf, Dale; Zolopa, Andrew

    2008-01-01

    Several genotypic interpretation scores have been proposed for the evaluation of susceptibility to lopinavir/ritonavir (LPV/r) but have not been compared using an independent data set. This study was a retrospective multicenter cohort of patients initiating LPV/r-based therapy. The virologic response (VR) was defined as a viral load of

  4. Association Between Nighttime Discharge from the Intensive Care Unit and Hospital Mortality: A Multi-Center Retrospective Cohort Study

    OpenAIRE

    Azevedo, Luciano CP; de Souza, Ivens A.; Zygun, David A; Stelfox, Henry T; Bagshaw, Sean M.

    2015-01-01

    Background We aimed to determine the impact of nighttime discharge from the intensive care unit (ICU) to the ward on hospital mortality and readmission rates in consecutive critically ill patients admitted to five Canadian ICUs. We hypothesized that hospital mortality and readmission rates would be higher for patients discharged after hours compared with discharge during the day. Methods A multi-center retrospective cohort study was carried out at five hospitals in Edmonton, Canada, between J...

  5. Mixed Membership Trajectory Models of Cognitive Impairment in the Multicenter AIDS Cohort Study

    Science.gov (United States)

    Molsberry, Samantha A.; Lecci, Fabrizio; Kingsley, Lawrence; Junker, Brian; Reynolds, Sandra; Goodkin, Karl; Levine, Andrew J.; Martin, Eileen; Miller, Eric N.; Munro, Cynthia A.; Ragin, Ann; Sacktor, Ned; Becker, James T.

    2016-01-01

    Objective The longitudinal trajectories that individuals may take from a state of normal cognition to HIV-associated dementia are unknown. We applied a novel statistical methodology to identify trajectories to cognitive impairment, and factors that affected the “closeness” of an individual to one of the canonical trajectories. Design The Multicenter AIDS Cohort Study (MACS) is a four-site longitudinal study of the natural and treated history of HIV Disease among gay and bisexual men. Methods Using data from 3,892 men (both HIV-infected and uninfected) enrolled in the neuropsychology substudy of the MACS, a Mixed Membership Trajectory Model (MMTM) was applied to capture the pathways from normal cognitive function to mild impairment to severe impairment. MMTMs allow the data to identify canonical pathways and to model the effects of risk factors on an individual’s “closeness” to these trajectories. Results We identified three distinct trajectories to cognitive impairment – one “normal aging” (low probability of mild impairment until age 60), one “premature aging” (mild impairment starting at age 45–50), and one “unhealthy” (mild impairment in 20s and 30s) profile. Second, clinically defined AIDS and not simply HIV Disease, was associated with closeness to the premature aging trajectory. And, third, Hepatitis-C infection, Depression, Race, Recruitment Cohort and Confounding Conditions all affected individual’s closeness to these trajectories. Conclusions These results provide new insight into the natural history of cognitive dysfunction in HIV disease and provide evidence for a potential difference in the pathophysiology of the development of cognitive impairment based on trajectories to impairment. PMID:25565498

  6. Pressure ulcer incidence in Dutch and German nursing homes: design of a prospective multicenter cohort study

    Directory of Open Access Journals (Sweden)

    Lohrmann Christa

    2011-04-01

    Full Text Available Abstract Background Pressure ulcers are a common and serious health care problem in all health care settings. Results from annual national pressure ulcer prevalence surveys in the Netherlands and Germany reveal large differences in prevalence rates between both countries over the past ten years, especially in nursing homes. When examining differences in prevalence and incidence rates, it is important to take into account all factors associated with the development of pressure ulcers. Numerous studies have identified patient related factors, as well as nursing related interventions as risk factors for the development of pressure ulcers. Next to these more process oriented factors, also structural factors such as staffing levels and staff quality play a role in the development of pressure ulcers. This study has been designed to investigate the incidence of pressure ulcers in nursing homes in the Netherlands and Germany and to identify patient related factors, nursing related factors and structural factors associated with pressure ulcer development. The present article describes the protocol for this study. Methods/design A prospective multicenter study is designed in which a cohort of newly admitted nursing home residents in 10 Dutch and 11 German nursing homes will be followed for a period of 12 weeks. Data will be collected by research assistants using questionnaires on four different levels: resident, staff, ward, and nursing home. Discussion The results of the study will provide information on the incidence of pressure ulcers in Dutch and German nursing homes. Furthermore, information will be gathered on the influence of patient related factors, nursing related factors and structural factors on the incidence of pressure ulcers. The present article describes the study design and addresses the study's strengths and weaknesses.

  7. "Burnout in Medical Oncology Fellows: a Prospective Multicenter Cohort Study in Brazilian Institutions".

    Science.gov (United States)

    Cubero, Daniel I G; Fumis, Renata Rego Lins; de Sá, Thiago Hérick; Dettino, Aldo; Costa, Felipe Osório; Van Eyll, Brigitte M R H Adam; Beato, Carlos; Peria, Fernanda Maris; Mota, Augusto; Altino, José; Azevedo, Sérgio Jobim; da Rocha Filho, Duílio Reis; Moura, Melba; Lessa, Álvaro Edson Ramos; Del Giglio, Auro

    2016-09-01

    Burnout syndrome is a common occurrence among oncologists. Doctors enrolled in residency programs in clinical oncology are exposed to similar risk factors; however, few data are available in this population. This study assessed the occurrence of burnout and associated factors among first-year residents at Brazilian institutions. The present prospective, multicenter, cohort study was conducted with doctors enrolled in residency programs in clinical oncology at Brazilian institutions affiliated with the public health system. The participants answered a sociodemographic questionnaire, the Maslach Burnout Inventory (MBI), Lipp's Stress Inventory, and the Beck Depression Inventory (BDI), upon admission to the program and 6 and 12 months later. Of 37 eligible residency programs in 2009, 11 (30.6 %) agreed to participate in the study. Fifty-four residents, representing 100 % of new admissions to the participating institutions, were included. Most of the participants met the criteria for severe burnout upon admission to the residency programs (emotional exhaustion in 49.0 % and depersonalization in 64.7 %). The scores on MBI domains emotional exhaustion and depersonalization increased significantly (p < 0.01) during the first year of residency, and the prevalence of burnout increased to 88 % at the end of that first year. The present study found a high prevalence of burnout among doctors enrolled in residency programs in clinical oncology at Brazilian institutions. A large fraction of the participants met the criteria for burnout syndrome upon admission to the program, which suggests that the problem began during the course of the previous residency program in internal medicine. PMID:25952940

  8. A hinged external fixator for complex elbow dislocations: A multicenter prospective cohort study

    Directory of Open Access Journals (Sweden)

    Verleisdonk Egbert JMM

    2011-06-01

    Full Text Available Abstract Background Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures of the radial head, olecranon, or coronoid process. The majority of patients with these complex dislocations are treated with open reduction and internal fixation (ORIF, or arthroplasty in case of a non-reconstructable radial head fracture. If the elbow joint remains unstable after fracture fixation, a hinged elbow fixator can be applied. The fixator provides stability to the elbow joint, and allows for early mobilization. The latter may be important for preventing stiffness of the joint. The aim of this study is to determine the effect of early mobilization with a hinged external elbow fixator on clinical outcome in patients with complex elbow dislocations with residual instability following fracture fixation. Methods/Design The design of the study will be a multicenter prospective cohort study of 30 patients who have sustained a complex elbow dislocation and are treated with a hinged elbow fixator following fracture fixation because of residual instability. Early active motion exercises within the limits of pain will be started immediately after surgery under supervision of a physical therapist. Outcome will be evaluated at regular intervals over the subsequent 12 months. The primary outcome is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford Elbow Score, pain level at both sides, range of motion of the elbow joint at both sides, radiographic healing of the fractures and formation of periarticular ossifications, rate of secondary interventions and complications, and health-related quality of life (Short-Form 36. Discussion The outcome of this study will yield quantitative data on the functional outcome in patients with a complex elbow dislocation and who are

  9. Multicenter trial of motion analysis for injury risk prediction: lessons learned from prospective longitudinal large cohort combined biomechanical - epidemiological studies

    Directory of Open Access Journals (Sweden)

    Timothy E. Hewett

    2015-10-01

    Full Text Available ABSTRACTOur biodynamics laboratory group has conducted large cohort biomechanical-epidemiological studies targeted at identifying the complex interactions among biomechanical, biological, hormonal, and psychosocial factors that lead to increased risk of anterior cruciate ligament (ACL injuries. The findings from our studies have revealed highly sensitive and specific predictors for ACL injury. Despite the high incidence of ACL injuries among young athletes, larger cohorts are needed to reveal the underlying mechanistic causes of increased risk for ACL injury. In the current study, we have outlined key factors that contribute to the overall success of multicenter, biomechanical-epidemiological investigations designed to test a larger number of athletes who otherwise could not be recruited, screened, or tested at a single institution. Twenty-five female volleyball players were recruited from a single high school team and tested at three biodynamics laboratories. All athletes underwent three-dimensional motion capture analysis of a drop vertical jump task. Kinematic and kinetic variables were compared within and among laboratories. Reliability of peak kinematic variables was consistently rated good-to-excellent. Reliability of peak kinetic variables was consistently rated goodto-excellent within sites, but greater variability was observed between sites. Variables measured in the sagittal plane were typically more reliable than variables measured in the coronal and transverse planes. This study documents the reliability of biomechanical variables that are key to identification of ACL injury mechanisms and of athletes at high risk. These findings indicate the feasibility of executing multicenter, biomechanical investigations that can yield more robust, reliable, and generalizable findings across larger cohorts of athletes.

  10. Short-Term Outcomes of Endoscopic Submucosal Dissection in Patients with Early Gastric Cancer: A Prospective Multicenter Cohort Study

    Science.gov (United States)

    Choi, Il Ju; Lee, Na Rae; Kim, Sang Gyun; Lee, Wan Sik; Park, Seun Ja; Kim, Jae J.; Lee, Jun Haeng; Kwon, Jin-Won; Park, Seung-Hee; You, Ji Hye; Kim, Ji Hyun; Lim, Chul-Hyun; Cho, Joo Young; Kim, Gwang Ha; Lee, Yong Chan; Jung, Hwoon-Yong; Kim, Ji Young; Chun, Hoon Jai; Seol, Sang-Yong

    2016-01-01

    Background/Aims Endoscopic submucosal dissection (ESD) is an effective treatment for early gastric cancer (EGC) that has demonstrated a minimal risk of lymph node metastasis in retrospective studies. We sought to prospectively evaluate the short-term outcomes of ESD treatment in EGCs. Methods A prospective multicenter cohort study of neoplasms 3 cm or less in diameter at endoscopic size evaluation was performed in 12 Korean ESD study group-related university hospitals and the National Cancer Center. Resected specimens were evaluated by the central pathologic review board. Results A patient cohort (n=712) with a total of 737 EGCs was analyzed. The margin-freeen bloc resection rate was 97.3%, and curative resection of 640 lesions (86.8%) was achieved. Lower curative resection rates were associated with lesions 2 to 3 cm in size prior to ESD compared with lesions 2 cm or less in size (78.6% vs 88.1%, respectively, p=0.009). Significant factors associated with noncurative resection were moderately or poorly differentiated histological type, posterior wall tumor location, tumor size larger than 3 cm, ulceration, and submucosal invasion. Delayed bleeding occurred in 49 patients (6.9%), and 12 patients (1.7%) exhibited perforations. Conclusions ESD is an effective treatment with a high curative resection rate for EGCs that meets relatively conservative pre-ESD indications. Long-term survival outcomes should be evaluated in follow-up studies. PMID:27172929

  11. Factors that Predict Negative Results of QuantiFERON-TB Gold In-Tube Test in Patients with Culture-Confirmed Tuberculosis: A Multicenter Retrospective Cohort Study

    OpenAIRE

    Kwon, Yong-Soo; Kim, Yee Hyung; Jeon, Kyeongman; Jeong, Byeong-Ho; Ryu, Yon Ju; Choi, Jae Chol; Kim, Ho Cheol; Koh, Won-Jung

    2015-01-01

    Background Interferon-γ release assays such as the QuantiFERON-TB Gold In-Tube Test (QFT-GIT) are designed to detect Mycobacterium tuberculosis infections, whether latent or manifesting as disease. However, a substantial number of persons with culture-confirmed tuberculosis (TB) have negative QFT-GITs. Information on host factors contributing to false-negative and indeterminate results are limited. Methods A multicenter retrospective cohort study was performed with 1,264 culture-confirmed TB ...

  12. Cumulative exposure to stimulants and immune function outcomes among HIV-positive and HIV-negative men in the Multicenter AIDS Cohort Study

    OpenAIRE

    Shoptaw, Steven; Stall, Ron; Bordon, Jose; Kao, Uyen; Cox, Christopher; Li, Xiuhong; Ostrow, David G.; Michael W. Plankey

    2012-01-01

    We examined associations between stimulant use (methamphetamine and cocaine) and other substances (nicotine, marijuana, alcohol, inhaled nitrites) with immune function biomarkers among HIV-seropositive (HIV+) men using highly active antiretroviral therapy (ART) and -seronegative (HIV−) men in the Multicenter AIDS Cohort Study (MACS). Among HIV+ men, cumulative adherence to ART (4.07, 95% CI: 3.52, 4.71, per 10 years of adherent HAART use), and recent cohort enrollment (1.38; 95% CI: 1.24, 1.5...

  13. Long-Term Cigarette Smoking Trajectories Among HIV-Seropositive and Seronegative MSM in the Multicenter AIDS Cohort Study.

    Science.gov (United States)

    Akhtar-Khaleel, Wajiha Z; Cook, Robert L; Shoptaw, Steve; Surkan, Pamela J; Teplin, Linda A; Stall, Ronald; Beyth, Rebecca J; Manini, Todd M; Plankey, Michael

    2016-08-01

    To examine the association between demographic characteristics and long-term smoking trajectory group membership among HIV-seropositive and HIV-seronegative men who have sex with men (MSM). A cohort of 6552 MSM from the Multicenter AIDS Cohort Study were asked detailed information about their smoking history since their last follow-up. Group-based trajectory modeling was used to examine smoking behavior and identify trajectory group membership. Because participants enrolled after 2001 were more likely to be younger, HIV-seronegative, non-Hispanic black, and have a high school diploma or less, we also assessed time of enrollment in our analysis. Participants were grouped into 4 distinct smoking trajectory groups: persistent nonsmoker (n = 3737 [55.9 %]), persistent light smoker (n = 663 [11.0 %]), heavy smoker to nonsmoker (n = 531 [10.0 %]), and persistent heavy smoker (n = 1604 [23.1 %]). Compared with persistent nonsmokers, persistent heavy smokers were associated with being enrolled in 2001 and later (adjusted odds ratio [aOR] 2.35; 95 % CI 2.12-2.58), having a high school diploma or less (aOR 3.22; 95 % CI 3.05-3.39), and being HIV-seropositive (aOR 1.17; 95 % CI 1.01-1.34). These associations were statistically significant across all trajectory groups for time of enrollment and education but not for HIV serostatus. The overall decrease of smoking as shown by our trajectory groups is consistent with the national trend. Characteristics associated with smoking group trajectory membership should be considered in the development of targeted smoking cessation interventions among MSM and people living with HIV. PMID:26922718

  14. Home Non-Invasive Ventilation Fails to Improve Quality of Life in the Elderly: Results from a Multicenter Cohort Study

    Science.gov (United States)

    Tissot, Adrien; Jaffre, Sandrine; Gagnadoux, Frédéric; Levaillant, Marc; Corne, Frédéric; Chollet, Sylvaine; Blanc, François-Xavier; Goupil, François; Priou, Pascaline; Trzepizur, Wojciech; Magnan, Antoine

    2015-01-01

    Background Home non-invasive ventilation (NIV) is a widely used treatment for chronic hypoventilation but little is known on its impact in the elderly. In a multicenter prospective cohort study, we studied tolerance and efficacy of domiciliary NIV in patients aged 75 or more compared to younger ones. Methods and Results 264 patients with at least a six-month follow-up were analyzed. Among them, 82 were elderly. In the elderly and the younger, we found an improvement of arterial blood gas, the Epworth sleepiness scale and the Pittsburgh sleep quality index at 6 months. Mean daily use of NIV at 6 months was 7 hours and the rate of non-adherent patients was similar in both group. Health-related quality of life (HRQL) assessed by SF-36 questionnaires did not change significantly after NIV initiation in the elderly whereas HRQL improved in the less than 75. On univariate analysis, we found that diabetes was a predictive factor for non-adherence in the elderly (Odds ratio: 3.95% confidence interval: 1.06–8.52). Conclusion NIV was efficient in the elderly while evaluation at 6 months showed a good adherence but failed to improve HRQL. PMID:26489014

  15. Home Non-Invasive Ventilation Fails to Improve Quality of Life in the Elderly: Results from a Multicenter Cohort Study.

    Directory of Open Access Journals (Sweden)

    Adrien Tissot

    Full Text Available Home non-invasive ventilation (NIV is a widely used treatment for chronic hypoventilation but little is known on its impact in the elderly. In a multicenter prospective cohort study, we studied tolerance and efficacy of domiciliary NIV in patients aged 75 or more compared to younger ones.264 patients with at least a six-month follow-up were analyzed. Among them, 82 were elderly. In the elderly and the younger, we found an improvement of arterial blood gas, the Epworth sleepiness scale and the Pittsburgh sleep quality index at 6 months. Mean daily use of NIV at 6 months was 7 hours and the rate of non-adherent patients was similar in both group. Health-related quality of life (HRQL assessed by SF-36 questionnaires did not change significantly after NIV initiation in the elderly whereas HRQL improved in the less than 75. On univariate analysis, we found that diabetes was a predictive factor for non-adherence in the elderly (Odds ratio: 3.95% confidence interval: 1.06-8.52.NIV was efficient in the elderly while evaluation at 6 months showed a good adherence but failed to improve HRQL.

  16. Trends and Predictors of Cigarette Smoking Among HIV Seropositive and Seronegative Men: The Multicenter Aids Cohort Study.

    Science.gov (United States)

    Akhtar-Khaleel, Wajiha Z; Cook, Robert L; Shoptaw, Steven; Surkan, Pamela; Stall, Ronald; Beyth, Rebecca J; Teplin, Linda A; Plankey, Michael

    2016-03-01

    We measured the trend of cigarette smoking among HIV-seropositive and seronegative men over time from 1984 to 2012. Additionally, we examined the demographic correlates of smoking and smoking consumption. Six thousand and five hundred and seventy seven men who have sex with men (MSM) from the Multicenter AIDS Cohort Study (MACS) were asked detailed information about their smoking history since their visit. Prevalence of smoking and quantity smoked was calculated yearly from 1984 to 2012. Poisson regression with robust error variance was used to estimate prevalence ratios of smoking in univariate and multivariate models. In 2012, 11.8 and 36.9 % of men who were enrolled in the MACS before 2001 or during or after 2001 smoked cigarettes, respectively. In the multivariate analysis, black, non-Hispanic, lower education, enrollment wave, alcohol use, and marijuana use were positively associated with current smoking in MSM. HIV serostatus was not significant in the multivariate analysis. However, HIV variables, such as detectable viral load, were positively associated. Though cigarette smoking has declined over time, the prevalence still remains high among subgroups. There is still a need for tailored smoking cessation programs to decrease the risk of smoking in HIV-seropositive MSM. PMID:26093780

  17. Pericardial effusion of HIV-infected patients - results of a prospective multicenter cohort study in the era of antiretroviral therapy

    Directory of Open Access Journals (Sweden)

    Lind A

    2011-11-01

    Full Text Available Abstract Background Patients with human immunodeficiency virus (HIV infection have an increased risk of cardiovascular diseases. Previous publications described pericardial effusion as one of the most common HlV-associated cardiac affiliations. The aim of the current study was to investigate if pericardial effusion still has a relevant meaning of HIV-infected patients in the era of antiretroviral therapy. Methods The HIV-HEART (HIV-infection and HEART disease study is a cardiology driven, prospective and multicenter cohort study. Outpatients with a known HIV-infection were recruited during a 20 month period in a consecutive manner from September 2004 to May 2006. The study comprehends classic parameters of HIV-infection, comprising CD4-cell count (cluster of differentiation and virus load, as well as non-invasive tests of cardiac diseases, including a thorough transthoracic echocardiography. Results 802 HIV-infected patients (female: 16.6% with a mean age of 44.2 ± 10.3 years, were included. Duration of HIV-infection since initial diagnosis was 7.6 ± 5.8 years. Of all participants, 85.2% received antiretroviral therapy. Virus load was detectable in 34.4% and CD4 - cell count was in 12.4% less than 200 cells/μL. Pericardial effusions were present in only two patients of the analysed population. None of the participants had signs of a relevant cardiovascular impairment by pericardial effusion. Conclusions Our results demonstrate that the era of antiretroviral therapy goes along with low rates of pericardial effusions in HIV-infected outpatients. Our findings are in contrast to the results of publications, performed before the common use of antiretroviral therapy.

  18. Risk factors for shunt malfunction in pediatric hydrocephalus: a multicenter prospective cohort study.

    Science.gov (United States)

    Riva-Cambrin, Jay; Kestle, John R W; Holubkov, Richard; Butler, Jerry; Kulkarni, Abhaya V; Drake, James; Whitehead, William E; Wellons, John C; Shannon, Chevis N; Tamber, Mandeep S; Limbrick, David D; Rozzelle, Curtis; Browd, Samuel R; Simon, Tamara D

    2016-04-01

    OBJECT The rate of CSF shunt failure remains unacceptably high. The Hydrocephalus Clinical Research Network (HCRN) conducted a comprehensive prospective observational study of hydrocephalus management, the aim of which was to isolate specific risk factors for shunt failure. METHODS The study followed all first-time shunt insertions in children younger than 19 years at 6 HCRN centers. The HCRN Investigator Committee selected, a priori, 21 variables to be examined, including clinical, radiographic, and shunt design variables. Shunt failure was defined as shunt revision, subsequent endoscopic third ventriculostomy, or shunt infection. Important a priori-defined risk factors as well as those significant in univariate analyses were then tested for independence using multivariate Cox proportional hazard modeling. RESULTS A total of 1036 children underwent initial CSF shunt placement between April 2008 and December 2011. Of these, 344 patients experienced shunt failure, including 265 malfunctions and 79 infections. The mean and median length of follow-up for the entire cohort was 400 days and 264 days, respectively. The Cox model found that age younger than 6 months at first shunt placement (HR 1.6 [95% CI 1.1-2.1]), a cardiac comorbidity (HR 1.4 [95% CI 1.0-2.1]), and endoscopic placement (HR 1.9 [95% CI 1.2-2.9]) were independently associated with reduced shunt survival. The following had no independent associations with shunt survival: etiology, payer, center, valve design, valve programmability, the use of ultrasound or stereotactic guidance, and surgeon experience and volume. CONCLUSIONS This is the largest prospective study reported on children with CSF shunts for hydrocephalus. It confirms that a young age and the use of the endoscope are risk factors for first shunt failure and that valve type has no impact. A new risk factor-an existing cardiac comorbidity-was also associated with shunt failure. PMID:26636251

  19. Screening for vulnerability in older cancer patients: the ONCODAGE Prospective Multicenter Cohort Study.

    Directory of Open Access Journals (Sweden)

    Pierre Soubeyran

    Full Text Available Geriatric Assessment is an appropriate method for identifying older cancer patients at risk of life-threatening events during therapy. Yet, it is underused in practice, mainly because it is time- and resource-consuming. This study aims to identify the best screening tool to identify older cancer patients requiring geriatric assessment by comparing the performance of two short assessment tools the G8 and the Vulnerable Elders Survey (VES-13.The diagnostic accuracy of the G8 and the (VES-13 were evaluated in a prospective cohort study of 1674 cancer patients accrued before treatment in 23 health care facilities. 1435 were eligible and evaluable. Outcome measures were multidimensional geriatric assessment (MGA, sensitivity (primary, specificity, negative and positive predictive values and likelihood ratios of the G8 and VES-13, and predictive factors of 1-year survival rate.Patient median age was 78.2 years (70-98 with a majority of females (69.8%, various types of cancer including 53.9% breast, and 75.8% Performance Status 0-1. Impaired MGA, G8, and VES-13 were 80.2%, 68.4%, and 60.2%, respectively. Mean time to complete G8 or VES-13 was about five minutes. Reproducibility of the two questionnaires was good. G8 appeared more sensitive (76.5% versus 68.7%, P =  0.0046 whereas VES-13 was more specific (74.3% versus 64.4%, P<0.0001. Abnormal G8 score (HR = 2.72, advanced stage (HR = 3.30, male sex (HR = 2.69 and poor Performance Status (HR = 3.28 were independent prognostic factors of 1-year survival.With good sensitivity and independent prognostic value on 1-year survival, the G8 questionnaire is currently one of the best screening tools available to identify older cancer patients requiring geriatric assessment, and we believe it should be implemented broadly in daily practice. Continuous research efforts should be pursued to refine the selection process of older cancer patients before potentially life-threatening therapy.

  20. East Mediterranean region sickle cell disease mortality trial: retrospective multicenter cohort analysis of 735 patients.

    Science.gov (United States)

    Karacaoglu, Pelin Kardaş; Asma, Suheyl; Korur, Aslı; Solmaz, Soner; Buyukkurt, Nurhilal Turgut; Gereklioglu, Cigdem; Kasar, Mutlu; Ozbalcı, Demircan; Unal, Selma; Kaya, Hasan; Gurkan, Emel; Yeral, Mahmut; Sariturk, Çagla; Boga, Can; Ozdogu, Hakan

    2016-05-01

    Sickle cell disease (SCD), one of the most common genetic disorders worldwide, is characterized by hemolytic anemia and tissue damage from the rigid red blood cells. Although hydroxyurea and transfusion therapy are administered to treat the accompanying tissue injury, whether either one prolongs the lifespan of patients with SCD is unknown. SCD-related mortality data are available, but there are few studies on mortality-related factors based on evaluations of surviving patients. In addition, ethnic variability in patient registries has complicated detailed analyses. The aim of this study was to investigate mortality and mortality-related factors among an ethnically homogeneous population of patients with SCD. The 735 patients (102 children and 633 adults) included in this retrospective cohort study were of Eti-Turk origin and selected from 1367 patients seen at 5 regional hospitals. A central population management system was used to control for records of patient mortality. Data reliability was checked by a data supervision group. Mortality-related factors and predictors were identified in univariate and multivariate analyses using a Cox regression model with stepwise forward selection. The study group included patients with homozygous hemoglobin S (Hgb S) disease (67 %), Hb S-β(0) thalassemia (17 %), Hgb S-β(+) thalassemia (15 %), and Hb S-α thalassemia (1 %). They were followed for a median of 66 ± 44 (3-148) months. Overall mortality at 5 years was 6.1 %. Of the 45 patients who died, 44 (6 %) were adults and 1 (0.1 %) was a child. The mean age at death was 34.1 ± 10 (18-54) years for males, 40.1 ± 15 (17-64) years for females, and 36.6 ± 13 (17-64) years overall. Hydroxyurea was found to have a notable positive effect on mortality (p = 0.009). Mortality was also significantly related to hypertension and renal damage in a univariate analysis (p = 0.015 and p = 0.000, respectively). Acute chest syndrome

  1. Risk factors for medial meniscal pathology on knee MRI in older U.S. adults: A multicenter prospective cohort study

    Science.gov (United States)

    Englund, Martin; Felson, David T.; Guermazi, Ali; Roemer, Frank W.; Wang, Ke; Crema, Michel D.; Lynch, John A.; Sharma, Leena; Segal, Neil A; Lewis, Cora E.; Nevitt, Michael C.

    2016-01-01

    Objectives Knee trauma is a known cause of meniscal tear. However, meniscal pathology where the aetiology is often unclear is a frequent finding on knee magnetic resonance imaging (MRI).Our objective was to investigate potential risk factors for medial meniscal lesions or extrusion in middle-aged and elderly persons. Methods Prospective cohort study using population-based subjects from Birmingham, Alabama and Iowa City, Iowa, United States (the Multicenter Osteoarthritis Study (MOST)). We studied 644 men and women aged 50 to 79 years with or at high risk of knee osteoarthritis (Kellgren and Lawrence grade 0 to 2) but with normal medial meniscal status at baseline. We scored paired baseline and 30-month 1.0T knee MRIs for meniscal lesions and extrusion (pathology) and evaluated the following systemic, knee-specific, and compartment-specific potential risk factors: age, sex, body mass index, bony enlargement of finger joints, knee trauma, leg-length inequality, and knee alignment. Results Of 791 knees, 77 (9.7%) had medial meniscal pathology at 30-months follow-up. Sixty-one of these 77 knees (81%) had no report of trauma during follow-up. Including all potential risk factors in the multivariable model, the adjusted odds ratio (OR) for medial meniscal pathology was 4.14 (95% confidence interval 2.06, 8.31) for knee trauma during follow-up, 1.64 (1.00, 2.70) for ≥5 bony enlargements of finger joints (vs. ≤4), and 2.00 (1.18, 3.40) for varus alignment (vs. not varus) at baseline exam. Further, obesity was a risk factor for the development of meniscal extrusion, OR 3.04 (1.04, 8.93) but not for meniscal lesions, OR 1.15 (0.52, 2.54). Conclusions Apart from knee trauma, possible generalised osteoarthritis, expressed as multiple bony enlargements of finger joints, varus alignment, and obesity are risk factors for medial meniscal pathology. PMID:21646417

  2. The prevalence of sacroilitis in psoriatic arthritis: new perspectives from a large, multicenter cohort. A Department of Veterans Affairs Cooperative Study

    International Nuclear Information System (INIS)

    Objective. To determine the prevalence of radiographic evidence of sacroiliitis in a large population of patients with psoriatic arthritis. Patients and design. Patients were recruited from 15 clinical centers. This was part of a large, multicenter study of patients with an established diagnosis of ankylosing spondylitis, psoriatic arthritis, or reactive arthritis. For this cohort, an established diagnosis of psoriatic arthritis was required, with cutaneous manifestations and involvement of at least three appendicular joints. At entry, patients were not selected for the presence of axial involvement. Radiographs - one anteroposterior view of the pelvis and one oblique view of each sacroiliac joint - were graded using the New York classification scale by a musculoskeletal radiologist masked to the specific diagnosis and clinical symptoms. Re-evaluation of 10% of the films 3 years later quantified intraobserver variability. Results. Two hundred and two patients with psoriatic arthritis were studied. Duration of the disease averaged 12 years; all patients had psoriasis and peripheral arthritis. The prevalence of radiographic evidence of sacroiliitis (grade 2 or higher) was 78%; 71% of these had grade 3 disease. Conclusions. Previously reported prevalence of sacroiliitis in patients with psoriatic arthritis ranges from 30% to 50%. The prevalence of radiographic evidence of sacroiliitis in this large multicenter cohort of patients with appendicular psoriatic arthritis was substantially higher. (orig.)

  3. The prevalence of sacroilitis in psoriatic arthritis: new perspectives from a large, multicenter cohort. A Department of Veterans Affairs Cooperative Study

    Energy Technology Data Exchange (ETDEWEB)

    Battistone, M.J.; Clegg, D.O. [Division of Rheumatology, University of Utah Medical Center, Salt Lake City, UT (United States)]|[Department of Medicine, Division of Rheumatology, Veterans Affairs Medical Center, Salt Lake City, UT (United States); Manaster, B.J. [Department of Radiology, Division of Musculoskeletal Imaging, Medical College of Virginia/Virginia Commonwealth University, Richmond, VA (United States); Reda, D.J. [Cooperative Studies Program Coordinating Center, VA Hospital, Hines, IL (United States)

    1999-04-01

    Objective. To determine the prevalence of radiographic evidence of sacroiliitis in a large population of patients with psoriatic arthritis. Patients and design. Patients were recruited from 15 clinical centers. This was part of a large, multicenter study of patients with an established diagnosis of ankylosing spondylitis, psoriatic arthritis, or reactive arthritis. For this cohort, an established diagnosis of psoriatic arthritis was required, with cutaneous manifestations and involvement of at least three appendicular joints. At entry, patients were not selected for the presence of axial involvement. Radiographs - one anteroposterior view of the pelvis and one oblique view of each sacroiliac joint - were graded using the New York classification scale by a musculoskeletal radiologist masked to the specific diagnosis and clinical symptoms. Re-evaluation of 10% of the films 3 years later quantified intraobserver variability. Results. Two hundred and two patients with psoriatic arthritis were studied. Duration of the disease averaged 12 years; all patients had psoriasis and peripheral arthritis. The prevalence of radiographic evidence of sacroiliitis (grade 2 or higher) was 78%; 71% of these had grade 3 disease. Conclusions. Previously reported prevalence of sacroiliitis in patients with psoriatic arthritis ranges from 30% to 50%. The prevalence of radiographic evidence of sacroiliitis in this large multicenter cohort of patients with appendicular psoriatic arthritis was substantially higher. (orig.) With 3 figs., 4 tabs., 29 refs.

  4. An Integrated System for Managing the Andalusian Parliament's Digital Library

    Science.gov (United States)

    de Campos, Luis M.; Fernandez-Luna, Juan M.; Huete, Juan F.; Martin-Dancausa, Carlos J.; Tagua-Jimenez, Antonio; Tur-Vigil, Carmen

    2009-01-01

    Purpose: The purpose of this paper is to present an overview of the reorganisation of the Andalusian Parliament's digital library to improve the electronic representation and access of its official corpus by taking advantage of a document's internal organisation. Video recordings of the parliamentary sessions have also been integrated with their…

  5. Radiation protection instrumentation at the Andalusian health service

    International Nuclear Information System (INIS)

    In Andalusia the contributions of radiological risks in the nuclear industry and of natural radiation are small and the same holds for medical applications of individuals and research. The performance models in radiation protection is monitored by the Andalusian Health Service through the public health institutions. This short communication describes the model and results obtained

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

    Science.gov (United States)

    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

  7. Mycoplasma genitalium Prevalence, Coinfection, and Macrolide Antibiotic Resistance Frequency in a Multicenter Clinical Study Cohort in the United States.

    Science.gov (United States)

    Getman, Damon; Jiang, Alice; O'Donnell, Meghan; Cohen, Seth

    2016-09-01

    The prevalence rates of Mycoplasma genitalium infections and coinfections with other sexually transmitted organisms and the frequency of a macrolide antibiotic resistance phenotype were determined in urogenital specimens collected from female and male subjects enrolled in a multicenter clinical study in the United States. Specimens from 946 subjects seeking care from seven geographically diverse clinical sites were tested for M. genitalium and for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis Sequencing was used to assess macrolide antibiotic resistance among M. genitalium-positive subjects. M. genitalium prevalence rates were 16.1% for females and 17.2% for males. Significant risk factors for M. genitalium infections were black race, younger age, non-Hispanic ethnicity, and female symptomatic status. Female M. genitalium infections were significantly more prevalent than C. trachomatis and N. gonorrhoeae infections, while the M. genitalium infection rate in males was significantly higher than the N. gonorrhoeae and T. vaginalis infection rates. The macrolide-resistant phenotype was found in 50.8% of females and 42% of males. These results show a high prevalence of M. genitalium single infections, a lower prevalence of coinfections with other sexually transmitted organisms, and high rates of macrolide antibiotic resistance in a diverse sample of subjects seeking care across a wide geographic area of the United States. PMID:27307460

  8. Cumulative exposure to stimulants and immune function outcomes among HIV-positive and HIV-negative men in the Multicenter AIDS Cohort Study

    Science.gov (United States)

    Shoptaw, Steven; Stall, Ron; Bordon, Jose; Kao, Uyen; Cox, Christopher; Li, Xiuhong; Ostrow, David G.; Plankey, Michael W.

    2013-01-01

    SUMMARY We examined associations between stimulant use (methamphetamine and cocaine) and other substances (nicotine, marijuana, alcohol, inhaled nitrites) with immune function biomarkers among HIV-seropositive (HIV+) men using highly active antiretroviral therapy (ART) and -seronegative (HIV−) men in the Multicenter AIDS Cohort Study (MACS). Among HIV+ men, cumulative adherence to ART (4.07, 95% CI: 3.52, 4.71, per 10 years of adherent HAART use), and recent cohort enrollment (1.38; 95% CI: 1.24, 1.55) were multiplicatively associated with increases in CD4+/CD8+ ratios. Cumulative use of methamphetamine (0.93; 95% CI: 0.88, 0.98, per 10 use years), cocaine (0.93; 95% CI: 0.89, 0.96, per 10 use years), and cumulative medical visits (0.99; 95% CI: 0.98, 0.99, per 10 visit years), each showed small negative associations with CD4+/CD8+ ratios. Among HIV- men, cumulative medical visits (0.996; 95% CI: 0.993, 0.999), cumulative number of male sexual partners (0.999; 95% CI: 0.998, 0.9998, per 10 partner years) and cigarette pack years (1.10; 95% CI: 1.02, 1.18, per 10 pack years) were associated with CD4+/CD8+ ratios over the same period. ART adherence is associated with a positive immune function independent of stimulant use, underscoring the influence of ART on immune health for HIV+ men who engage in stimulant use. PMID:22930295

  9. Recurrent Thrombotic Events after Discontinuation of Vitamin K Antagonist Treatment for Splanchnic Vein Thrombosis: A Multicenter Retrospective Cohort Study

    OpenAIRE

    Nicoletta Riva; Walter Ageno; Daniela Poli; Sophie Testa; Serena Rupoli; Rita Santoro; Teresa Lerede; Antonietta Piana; Monica Carpenedo; Alberto Nicolini; Piera Maria Ferrini; Giuliana Martini; Catello Mangione; Laura Contino; Carlo Bonfanti

    2015-01-01

    It is generally recommended that patients with splanchnic vein thrombosis (SVT) should receive a minimum of 3 months of anticoagulant treatment. However, little information is available on the long-term risk of recurrent thrombotic events. The aim of this study was to evaluate the risk of venous and arterial thrombosis after discontinuation of vitamin K antagonist (VKA) in SVT patients. Retrospective information from a cohort of SVT patients treated with VKA and followed by 37 Italian Anticoa...

  10. Study protocol of the B-CAST study: a multicenter, prospective cohort study investigating the tumor biomarkers in adjuvant chemotherapy for stage III colon cancer

    International Nuclear Information System (INIS)

    Adjuvant chemotherapy for stage III colon cancer is internationally accepted as standard treatment with established efficacy. Several oral fluorouracil (5-FU) derivatives with different properties are available in Japan, but which drug is the most appropriate for each patient has not been established. Although efficacy prediction of 5-FU derivatives using expression of 5-FU activation/metabolism enzymes in tumors has been studied, it has not been clinically applied. The B-CAST study is a multicenter, prospective cohort study aimed to identify the patients who benefit from adjuvant chemotherapy with each 5-FU regimen, through evaluating the relationship between tumor biomarker expression and treatment outcome. The frozen tumor specimens of patients with stage III colon cancer who receives postoperative adjuvant chemotherapy are examined. Protein expression of thymidine phosphorylase (TP), dihydropyrimidine dehydrogenase (DPD), epidermal growth factor receptor (EGFR), and vascular endothelial growth factor (VEGF) are evaluated using enzyme-linked immunosorbent assay (ELISA). mRNA expression of TP, DPD, thymidylate synthase (TS) and orotate phosphoribosyl transferase (OPRT) are evaluated using reverse transcription polymerase chain reaction (RT-PCR). The patients’ clinical data reviewed are as follow: demographic and pathological characteristics, regimen, drug doses and treatment duration of adjuvant therapy, types and severity of adverse events, disease free survival, relapse free survival and overall survival. Then, relationships among the protein/mRNA expression, clinicopathological characteristics and the treatment outcomes are analyzed for each 5-FU derivative. A total of 2,128 patients from the 217 institutions were enrolled between April 2009 and March 2012. The B-CAST study demonstrated that large-scale, multicenter translational research using frozen samples was feasible when the sample shipment and Web-based data collection were well organized. The results

  11. Effectiveness and tolerability of abacavir-lamivudine-nevirapine (ABC/3TC/NVP in a multicenter cohort of HIV-infected ARV-experienced patients

    Directory of Open Access Journals (Sweden)

    D Podzamczer

    2012-11-01

    Full Text Available Purpose of the study: Very scarce information has been published to date with the combination of ABC/3TC/NVP but it is currently being used in clinical practice in many centers in Spain. Our aim was to present the clinical experience with this regimen in a cohort of adult HIV-infected pts. Methods: Retrospective, multicenter, cohort study. Consecutive adult HIV-infected ARV-experienced pts, HLA-B*5701-negative, who started ABC/3TC/NVP between 2005–2010, with at least one follow-up visit, were included. Demographic, clinical and laboratory variables were assessed at baseline, month 1, and every 3–4 months thereafter. The primary end point was HIV-1 viral load (VL <40 c/mL at 48 weeks. Data were analyzed by intent-to-treat (ITT (non-completer=failure and on treatment (OT. Summary of results: 227 pts were included and followed up for a median of 30 (0.5–76 months. 75% male, 47 (24–83 years, 21% AIDS, 13% HCV+, baseline CD4 570 (32–1404 cells/µL and VL undetectable in 90% with a median of <1.59 (<1.59–5.1 log. Most pts were receiving NVP (63%, ABC (25% or both (4% in the previous regimen. ABC/3TC/NVP was initiated due to toxicity (42%, simplification (35% or other reasons (22% including to reduce drug cost. After 48 weeks, VL was <40 c/mL in 82% (ITT and 94% (OT, and in 94% (OT after 96 weeks. CD4 increased +63 (p<0.001 and +77 (p<0.001 cells/µL after 48 and 96 weeks, respectively. One or more drugs of the regimen were discontinued in 18% of pts during follow up: toxicity (7%, virologic failure (3%, lost to follow-up (3%, unrelated death (0.4% or other reasons (4%. No significant differences were observed in ALT, AST, or triglyceride changes during follow up. A significant increase of 7%, 10% and 14% was observed in total cholesterol, LDLc and HDLc, and a significant decrease in TC/HDL ratio (−5%, p=0.004 after 96 weeks, respectively. Conclusions: In this particular cohort of ARV-experienced pts previously receiving NVP or ABC, a

  12. Retrospective benzene exposure assessment for a multi-center case-cohort study of benzene-exposed workers in China.

    Science.gov (United States)

    Portengen, Lützen; Linet, Martha S; Li, Gui-Lan; Lan, Qing; Dores, Graça M; Ji, Bu-Tian; Hayes, Richard B; Yin, Song-Nian; Rothman, Nathaniel; Vermeulen, Roel

    2016-05-01

    Quality of exposure assessment has been shown to be related to the ability to detect risk of lymphohematopoietic disorders in epidemiological investigations of benzene, especially at low levels of exposure. We set out to build a statistical model for reconstructing exposure levels for 2898 subjects from 501 factories that were part of a nested case-cohort study within the NCI-CAPM cohort of more than 110,000 workers. We used a hierarchical model to allow for clustering of measurements by factory, workshop, job, and date. To calibrate the model we used historical routine monitoring data. Measurements below the limit of detection were accommodated by constructing a censored data likelihood. Potential non-linear and industry-specific time-trends and predictor effects were incorporated using regression splines and random effects. A partial validation of predicted exposures in 2004/2005 was performed through comparison with full-shift measurements from an exposure survey in facilities that were still open. Median cumulative exposure to benzene at age 50 for subjects that ever held an exposed job (n=1175) was 509 mg/m(3) years. Direct comparison of model estimates with measured full-shift personal exposure in the 2004/2005 survey showed moderate correlation and a potential downward bias at low (<1 mg/m(3)) exposure estimates. The modeling framework enabled us to deal with the data complexities generally found in studies using historical exposure data in a comprehensive way and we therefore expect to be able to investigate effects at relatively low exposure levels. PMID:26264985

  13. Factors that Predict Negative Results of QuantiFERON-TB Gold In-Tube Test in Patients with Culture-Confirmed Tuberculosis: A Multicenter Retrospective Cohort Study.

    Directory of Open Access Journals (Sweden)

    Yong-Soo Kwon

    Full Text Available Interferon-γ release assays such as the QuantiFERON-TB Gold In-Tube Test (QFT-GIT are designed to detect Mycobacterium tuberculosis infections, whether latent or manifesting as disease. However, a substantial number of persons with culture-confirmed tuberculosis (TB have negative QFT-GITs. Information on host factors contributing to false-negative and indeterminate results are limited.A multicenter retrospective cohort study was performed with 1,264 culture-confirmed TB patients older than 18 years who were subjected to the QFT-GIT at one of the six hospitals between May 2007 and February 2014. Patients with human immunodeficiency virus infection were excluded. Clinical and laboratory data were collected in South Korea.Of all patients, 87.6% (1,107/1,264 were diagnosed with pulmonary TB and 12.4% (157/1,264 with extrapulmonary TB. The rate of negative results was 14.4% (182/1,264. The following factors were highly correlated with false-negative results in the QFT-GIT: advanced age (age ≥ 65 years, odds ratio [OR] 1.57, 95% confidence interval [CI] 1.03-2.39, bilateral disease as determined by chest radiography (OR 1.75, 95% CI 1.13-2.72, malignancy (OR 2.42, 95% CI 1.30-4.49, and lymphocytopenia (total lymphocyte count < 1.0 × 109/L, OR 1.86, 95% CI 1.21-2.87.Consequently, QFT-GIT results need to be interpreted with caution in patients with these host risk factors such as the elderly, bilateral disease on chest radiography, or malignancy, or lymphocytopenia.

  14. De novo CD5+ diffuse large B-cell lymphoma: Adverse outcomes with and without stem cell transplantation in a large, multicenter, rituximab treated cohort.

    Science.gov (United States)

    Alinari, Lapo; Gru, Alejandro; Quinion, Carl; Huang, Ying; Lozanski, Arletta; Lozanski, Gerard; Poston, Jacqueline; Venkataraman, Girish; Oak, Eunhye; Kreisel, Friederike; Park, Steven I; Matthews, Stephanie; Abramson, Jeremy S; Iris Lim, Hana; Martin, Peter; Cohen, Jonathon B; Evens, Andrew; Al-Mansour, Zeina; Singavi, Arun; Fenske, Timothy S; Blum, Kristie A

    2016-06-01

    De novo CD5+ diffuse large B-cell lymphomas (DLBCL) are a distinct subgroup of DLBCL with poor prognosis. However the role of rituximab-containing therapy and salvage stem cell transplantation in this patients' population remain to be defined. We retrospectively reviewed clinical features and outcomes of 102 patients with de novo CD5+ DLBCL treated with rituximab-containing therapy at nine different institutions. By Hans' criteria, 64 patients had activated B-cell (ABC) subtype, 24 germinal center B-cell (GCB) subtype, and 14 were not evaluated. No patients had a myc translocation. Eighty-three patients were treated with rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP), 7 with rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine, prednisone (R-EPOCH), and 6 with R-CHOP with methotrexate, 3 g/m(2) . The overall response rate to front-line therapy was 85%. The 3-year progression free survival (PFS) and overall survival (OS) for all patients were 40 and 65%, respectively. The 3-year PFS for ABC- and GCB-subtypes was 34 and 45%, respectively. The 3-year OS for ABC- and GCB-subtypes was 62 and 67%, respectively. The median time to second treatment failure was 3 months and 1 month for ABC- and GCB-subtypes, respectively. Twenty of 28 (71%) transplanted patients with autologous, allogeneic, or both, relapsed. This study confirms the poor prognosis of de novo CD5+ DLBCL in a large multi-center cohort despite initial rituximab-containing chemotherapy and suggests that stem cell transplantation fails to salvage the majority of these patients. Approaches to prevent recurrence and/or novel therapies for relapsed disease are needed for this subgroup of DLBCL patients. Am. J. Hematol. 91:395-399, 2016. © 2016 Wiley Periodicals, Inc. PMID:26800311

  15. Improved safety of biologic therapy for rheumatoid arthritis over the 8-year period since implementation in Japan: long-term results from a multicenter observational cohort study.

    Science.gov (United States)

    Kojima, Toshihisa; Takahashi, Nobunori; Funahashi, Koji; Asai, Shuji; Terabe, Kenya; Kaneko, Atsushi; Hirano, Yuji; Hayashi, Masatoshi; Miyake, Hiroyuki; Oguchi, Takeshi; Takagi, Hideki; Kanayama, Yasuhide; Yabe, Yuichiro; Watanabe, Tsuyoshi; Fujibayashi, Takayoshi; Shioura, Tomone; Ito, Takayasu; Yoshioka, Yutaka; Ishikawa, Hisato; Asai, Nobuyuki; Takemoto, Toki; Kojima, Masayo; Ishiguro, Naoki

    2016-04-01

    This study aimed to compare the long-term safety of biologics by initiation year of treatment in patients with rheumatoid arthritis (RA) in Japan. RA patients who started their first biologics including infliximab, etanercept, adalimumab, and tocilizumab between 2003 and 2008 were identified in the Tsurumai Biologics Communication Registry (TBCR), multicenter observational cohort, and followed for 2 years or until discontinuation of the drugs. We identified baseline predictors for adverse events (AEs) resulting in discontinuation of the first TNFI using Cox proportional hazards regression analysis. A total of 874 cases (1,340 person-years) were observed. During the observation period, 96 AEs (4.7 events/100 person-years) occurred. From 2003 to 2008, there were significant changes in disease duration, Steinbrocker stage, and disease activity in those aged ≤64 years with no increase of incidence of AEs, whereas those aged >64 years had no significant changes in these variables. In the later initiation year of treatment with biologics, the fewer AEs were observed (log-rank, p = 0.017, 2008 vs. 2003-2005). Multivariate analysis showed that the initiation year significantly impacted the incidence of AEs 6 months into the observation period [initiation at 2008 (vs. 2003-2005): OR: 0.30, 95 % CI: (0.14-0.68)] after adjusting for variables at baseline. The decrease of AEs in the later initiation year was evident in those aged >64 years. The safety of biologic therapy improved over the course of the 8 years from its implementation in Japan. PMID:26846135

  16. Comparison of Insulin Resistance to Coronary Atherosclerosis in Human Immunodeficiency Virus Infected and Uninfected Men (from the Multicenter AIDS Cohort Study).

    Science.gov (United States)

    Brener, Michael I; Post, Wendy S; Haberlen, Sabina A; Zhang, Long; Palella, Frank J; Jacobson, Lisa P; Dobs, Adrian S; George, Richard T; Witt, Mallory D; Budoff, Matthew; Kingsley, Lawrence A; Brown, Todd T

    2016-03-15

    The relation between insulin resistance (IR) and coronary artery disease in patients with human immunodeficiency virus (HIV) infection remains incompletely defined. Fasting serum insulin and glucose measurements from 448 HIV-infected and 306 uninfected men enrolled in the Multicenter AIDS Cohort Study were collected at semiannual visits from 2003 to 2013 and used to compute the homeostatic model assessment of IR (HOMA-IR). Coronary computed tomographic angiography (CTA) was performed at the end of the study period to characterize coronary pathology. Associations between HOMA-IR (categorized into tertiles and assessed near the time of the CTA and over the 10-year study period) and the prevalence of coronary plaque or stenosis ≥50% were assessed with multivariate logistic regression. HOMA-IR was higher in HIV-infected men than HIV-uninfected men when measured near the time of CTA (3.2 vs 2.7, p = 0.002) and when averaged over the study period (3.4 vs 3.0, p <0.001). The prevalence of coronary stenosis ≥50% was similar between both groups (17% vs 15%, p = 0.41). Both measurements of HOMA-IR were associated with greater odds of coronary stenosis ≥50% in models comparing men with values in the highest versus the lowest tertiles, although the effect of mean HOMA-IR was stronger than the single measurement of HOMA-IR before CTA (odds ratio 2.46, 95% CI 1.95 to 3.11, vs odds ratio 1.43, 1.20 to 1.70). This effect was not significantly modified by HIV serostatus. In conclusion, IR over nearly a decade was greater in HIV-infected men than HIV-uninfected men, and in both groups, was associated with significant coronary artery stenosis. PMID:26830260

  17. Recurrent Thrombotic Events after Discontinuation of Vitamin K Antagonist Treatment for Splanchnic Vein Thrombosis: A Multicenter Retrospective Cohort Study

    Science.gov (United States)

    Riva, Nicoletta; Ageno, Walter; Poli, Daniela; Testa, Sophie; Rupoli, Serena; Santoro, Rita; Lerede, Teresa; Piana, Antonietta; Carpenedo, Monica; Nicolini, Alberto; Ferrini, Piera Maria; Martini, Giuliana; Mangione, Catello; Contino, Laura; Bonfanti, Carlo; Gresele, Paolo; Tosetto, Alberto

    2015-01-01

    It is generally recommended that patients with splanchnic vein thrombosis (SVT) should receive a minimum of 3 months of anticoagulant treatment. However, little information is available on the long-term risk of recurrent thrombotic events. The aim of this study was to evaluate the risk of venous and arterial thrombosis after discontinuation of vitamin K antagonist (VKA) in SVT patients. Retrospective information from a cohort of SVT patients treated with VKA and followed by 37 Italian Anticoagulation Clinics, up to June 2013, was collected. Only patients who discontinued VKA and did not receive any other anticoagulant drug were enrolled in this study. Thrombotic events during follow-up were centrally adjudicated. Ninety patients were included: 33 unprovoked SVT, 27 SVT secondary to transient risk factors, and 30 with permanent risk factors. During a median follow-up of 1.6 years, 6 venous and 1 arterial thrombosis were documented, for an incidence of 3.3/100 patient-years (pt-y). The recurrence rate was highest in the first year after VKA discontinuation (8.2/100'pt-y) and in patients with permanent risk factors (10.2/100'pt-y). Liver cirrhosis significantly increased the risk of recurrence. In conclusion, the rate of recurrent vascular complications after SVT is not negligible, at least in some patient subgroups. PMID:26508913

  18. Recurrent Thrombotic Events after Discontinuation of Vitamin K Antagonist Treatment for Splanchnic Vein Thrombosis: A Multicenter Retrospective Cohort Study

    Directory of Open Access Journals (Sweden)

    Nicoletta Riva

    2015-01-01

    Full Text Available It is generally recommended that patients with splanchnic vein thrombosis (SVT should receive a minimum of 3 months of anticoagulant treatment. However, little information is available on the long-term risk of recurrent thrombotic events. The aim of this study was to evaluate the risk of venous and arterial thrombosis after discontinuation of vitamin K antagonist (VKA in SVT patients. Retrospective information from a cohort of SVT patients treated with VKA and followed by 37 Italian Anticoagulation Clinics, up to June 2013, was collected. Only patients who discontinued VKA and did not receive any other anticoagulant drug were enrolled in this study. Thrombotic events during follow-up were centrally adjudicated. Ninety patients were included: 33 unprovoked SVT, 27 SVT secondary to transient risk factors, and 30 with permanent risk factors. During a median follow-up of 1.6 years, 6 venous and 1 arterial thrombosis were documented, for an incidence of 3.3/100 patient-years (pt-y. The recurrence rate was highest in the first year after VKA discontinuation (8.2/100’pt-y and in patients with permanent risk factors (10.2/100’pt-y. Liver cirrhosis significantly increased the risk of recurrence. In conclusion, the rate of recurrent vascular complications after SVT is not negligible, at least in some patient subgroups.

  19. Recurrent differentiated thyroid cancer: towards personalized treatment based on evaluation of tumor characteristics with PET (THYROPET Study): study protocol of a multicenter observational cohort study

    International Nuclear Information System (INIS)

    After initial treatment of differentiated thyroid carcinoma (DTC) patients are followed with thyroglobulin (Tg) measurements to detect recurrences. In case of elevated levels of Tg and negative neck ultrasonography, patients are treated 'blindly' with Iodine-131 (131I). However, in up to 50% of patients, the post-therapy scan reveals no 131I-targeting of tumor lesions. Such patients derive no benefit from the blind therapy but are exposed to its toxicity. Alternatively, iodine-124 (124I) Positron Emission Tomography/Computed Tomography (PET/CT) has become available to visualize DTC lesions and without toxicity. In addition to this, 18F-fluorodeoxyglucose (18F-FDG) PET/CT detects the recurrent DTC phenotype, which lost the capacity to accumulate iodine. Taken together, the combination of 124I and 18F-FDG PET/CT has potential to stratify patients for treatment with 131I. In a multicenter prospective observational cohort study the hypothesis that the combination of 124I and 18F-FDG PET/CT can avoid futile 131I treatments in patients planned for ‘blind’ therapy with 131I, is tested. One hundred patients planned for 131I undergo both 124I and 18F-FDG PET/CT after rhTSH stimulation. Independent of the outcome of the scans, all patients will subsequently receive, after thyroid hormone withdrawal, the 131I therapy. The post 131I therapeutic scintigraphy is compared with the outcome of the 124I and 18F-FDG PET/CT in order to evaluate the diagnostic value of the combined PET modalities. This study primary aims to reduce the number of futile 131I therapies. Secondary aims are the nationwide introduction of 124I PET/CT by a quality assurance and quality control (QA/QC) program, to correlate imaging outcome with histopathological features, to compare 124I PET/CT after rhTSH and after withdrawal of thyroid hormone, and to compare 124I and 131I dosimetry. This study aims to evaluate the potential value of the combination of 124I and 18F-FDG PET/CT in the prevention

  20. Mortality among critically ill patients with methicillin-resistant Staphylococcus aureus bacteremia: a multicenter cohort study in Colombia Mortalidad en pacientes gravemente enfermos con bacteriemia por Staphylococcus aureus resistente a la meticilina: un estudio multicéntrico de cohortes en Colombia

    OpenAIRE

    Juan S. Castillo; Aura L Leal; Jorge A. Cortes; Alvarez, Carlos A; Ricardo Sanchez; Giancarlo Buitrago; Liliana I. Barrero; Andrés L. Gonzalez; Daibeth H. Henriquez

    2012-01-01

    OBJECTIVE: To evaluate risk factors associated with methicillin-resistant Staphylococcus aureus (MRSA) bacteremia emergence, its prognosis, and mortality-determining factors in critically ill patients in Colombia. METHODS: A multicenter, retrospective cohort study conducted in 2005-2008 at 16 public and private reference health care institutions in Bogotá, Colombia, that form part of a national epidemiological surveillance network and a hospital network with 4 469 beds. Methicillin-resistant ...

  1. Observational Study of a French and Belgian Multicenter Cohort of 23 Patients Diagnosed in Adulthood With Mevalonate Kinase Deficiency.

    Science.gov (United States)

    Durel, Cécile-Audrey; Aouba, Achille; Bienvenu, Boris; Deshayes, Samuel; Coppéré, Brigitte; Gombert, Bruno; Acquaviva-Bourdain, Cécile; Hachulla, Eric; Lecomte, Frédéric; Touitou, Isabelle; Ninet, Jacques; Philit, Jean-Baptiste; Messer, Laurent; Brouillard, Marc; Girard-Madoux, Marie-Hélène; Moutschen, Michel; Raison-Peyron, Nadia; Hutin, Pascal; Duffau, Pierre; Trolliet, Pierre; Hatron, Pierre-Yves; Heudier, Philippe; Cevallos, Ramiro; Lequerré, Thierry; Brousse, Valentine; Lesire, Vincent; Audia, Sylvain; Maucort-Boulch, Delphine; Cuisset, Laurence; Hot, Arnaud

    2016-03-01

    The aim of this study was to describe the clinical and biological features of Mevalonate kinase deficiency (MKD) in patients diagnosed in adulthood. This is a French and Belgian observational retrospective study from 2000 to 2014. To constitute the cohort, we cross-check the genetic and biochemical databases. The clinical, enzymatic, and genetic data were gathered from medical records. Twenty-three patients were analyzed. The mean age at diagnosis was 40 years, with a mean age at onset of symptoms of 3 years. All symptomatic patients had fever. Febrile attacks were mostly associated with arthralgia (90.9%); lymphadenopathy, abdominal pain, and skin lesions (86.4%); pharyngitis (63.6%); cough (59.1%); diarrhea, and hepatosplenomegaly (50.0%). Seven patients had psychiatric symptoms (31.8%). One patient developed recurrent seizures. Three patients experienced renal involvement (13.6%). Two patients had angiomyolipoma (9.1%). All but one tested patients had elevated serum immunoglobulin (Ig) D level. Twenty-one patients had genetic diagnosis; most of them were compound heterozygote (76.2%). p.Val377Ile was the most prevalent mutation. Structural articular damages and systemic AA amyloidosis were the 2 most serious complications. More than 65% of patients displayed decrease in severity and frequency of attacks with increasing age, but only 35% achieved remission. MKD diagnosed in adulthood shared clinical and genetic features with classical pediatric disease. An elevated IgD concentration is a good marker for MKD in adults. Despite a decrease of severity and frequency of attacks with age, only one-third of patients achieved spontaneous remission. PMID:26986117

  2. Stakeholder analysis: theAndalusian Agency For Healthcare Quality case.

    Science.gov (United States)

    Reyes-Alcázar, Víctor; Casas-Delgado, Marta; Herrera-Usagre, Manuel; Torres-Olivera, Antonio

    2012-01-01

    The aim of this study was to identify the different groups that can affect or be affected by an agency charged with the promoting and guaranteeing of health care quality in Andalusian region (Spain) and to provide a framework with the stakeholders included in different categories. The study adopted a cross-sectional research design. A case study with structured interviews among Andalusian Agency for Healthcare Quality Steering Committee members was carried out in 2010 to define stakeholders' categories and map the interest groups using 5 attributes: influence, importance, legitimacy, power, and urgency. After identification and categorization, stakeholders were weighted qualitatively according to the attributes of importance and influence using 4 possible levels. A matrix was made with the collected data relating both attributes. Furthermore, 8 different types of stakeholders were identified according to attributes power, legitimacy, and urgency. The study concludes that identifying and classifying stakeholders are fundamental to ensuring the success of an organization that must respond to needs and expectations, especially those of its clients. Moreover, knowing stakeholder linkages can contribute to increase organizational worth. This is essential for organizations basically directed to the provision of services in the scope of health care. PMID:23111489

  3. Predicting the outcome of chronic kidney disease by the estimated nephron number: The rationale and design of PRONEP, a prospective, multicenter, observational cohort study

    Directory of Open Access Journals (Sweden)

    Imasawa Toshiyuki

    2012-03-01

    Full Text Available Abstract Background The nephron number is thought to be associated with the outcome of chronic kidney disease (CKD. If the nephron number can be estimated in the clinical setting, it could become a strong tool to predict renal outcome. This study was designed to estimate the nephron number in CKD patients and to establish a method to predict the outcome by using the estimated nephron number. Methods/Design The hypothesis of this study is that the estimated nephron number can predict the outcome of a CKD patient. This will be a multicenter, prospective (minimum 3 and maximum 5 years follow-up study. The subjects will comprise CKD patients aged over 14 years who have undergone a kidney biopsy. From January 2011 to March 2013, we will recruit 600 CKD patients from 10 hospitals belonging to the National Hospital Organization of Japan. The primary parameter for assessment is the composite of total mortality, renal death, cerebro-cardiovascular events, and a 50% reduction in the eGFR. The secondary parameter is the rate of eGFR decline per year. The nephron number will be estimated by the glomerular density in biopsy specimens and the renal cortex volume. This study includes one sub-cohort study to establish the equation to calculate the renal cortex volume. Enrollment will be performed at the time of the kidney biopsy, and the data will consist of a medical interview, ultrasound for measurement of the kidney size, blood or urine test, and the pathological findings of the kidney biopsy. Patients will continue to have medical consultations and receive examinations and/or treatment as usual. The data from the patients will be collected once a year after the kidney biopsy until March 2016. All data using this study are easily obtained in routine clinical practice. Discussion This study includes the first trials to estimate the renal cortex volume and nephron number in the general clinical setting. Furthermore, this is the first prospective study to

  4. Diagnostic accuracy of early urinary index changes in differentiating transient from persistent acute kidney injury in critically ill patients: multicenter cohort study

    OpenAIRE

    Pons, Bertrand; Lautrette, Alexandre; Oziel, Johanna; Dellamonica, Jean; Vermesch, Régine; Ezingeard, Eric; Mariat, Christophe; Bernardin, Gilles; Zeni, Fabrice; Cohen, Yves; Tardy, Bernard; Souweine, Bertrand; Vincent, François; Darmon, Michael

    2013-01-01

    Introduction Urinary indices have limited effectiveness in separating transient acute kidney injury (AKI) from persistent AKI in ICU patients. Their time-course may vary with the mechanism of AKI. The primary objective of this study was to evaluate the diagnostic value of changes over time of the usual urinary indices in separating transient AKI from persistent AKI. Methods An observational prospective multicenter study was performed in six ICUs involving 244 consecutive patients, including 9...

  5. The impact of breast cancer biological subtyping on tumor size assessment by ultrasound and mammography - a retrospective multicenter cohort study of 6543 primary breast cancer patients

    OpenAIRE

    Stein, Roland Gregor; Wollschläger, Daniel; Kreienberg, Rolf; Janni, Wolfgang; Wischnewsky, Manfred; Diessner, Joachim; Stüber, Tanja; Bartmann, Catharina; Krockenberger, Mathias; Wischhusen, Jörg; Wöckel, Achim; Blettner, Maria; Schwentner, Lukas; ,

    2016-01-01

    Background Mammography and ultrasound are the gold standard imaging techniques for preoperative assessment and for monitoring the efficacy of neoadjuvant chemotherapy in breast cancer. Maximum accuracy in predicting pathological tumor size non-invasively is critical for individualized therapy and surgical planning. We therefore aimed to assess the accuracy of tumor size measurement by ultrasound and mammography in a multicentered health services research study. Methods We retrospectively anal...

  6. Andalusian contribution to the creation of a cross-border in the Spanish-Moroccan border

    Directory of Open Access Journals (Sweden)

    Rosa Jordá Borrel

    2002-01-01

    Full Text Available This article will be centered in the way of evolving flow of the exterior trade between Andalusia and Morocco, and the strategies of the economic Andalusian agents to penetrate within the Morocco market taking advantage of the growing demand and the low prices of labor, all of these without forgetting that the free exchange zone started in 1996, and is too early to make a deep analysis of this matter. Secondly, we want to measure the level of participation of the Andalusian Autonomous Community to build infrastructure (ports, electric stations, thermoelectric, airports, telecommunications, health and equipping local, regional and national Moroccan communities, due to it constitutes another way to penetrate in the Andalusian market, and can be considered another way of Andalusia sharing in the development process of the Moroccan free trade zone, since it is twice inserted in said process as a region of the European Union and as a door of Europe.

  7. Ethical attitudes of Andalusian journalists to deal with especially sensitive issues

    Directory of Open Access Journals (Sweden)

    JC Suárez Villegas

    2013-04-01

    Full Text Available Introduction. This research article analyses the positions of Andalusian journalists in relation to especially sensitive issues. Methods. The study combines qualitative and quantitative techniques: in-depth interviews and a questionnaire-based survey, respectively. Results. The professional work of Andalusian journalists is based more on the predominant values of their communities than on the deontological codes of the profession, which are unknown by the vast majority. Conclusions. Journalists exhibit a liberal spirit, which is characteristic of a secular society, and believe that the freedom of expression should be respected when dealing with especially sensitive issues, which must be resolved according to the particular circumstances of each case.

  8. LINEAR GENERAL EQUILIBRIUM MODEL OF ENERGY DEMAND AND CO2 EMISSIONS GENERATED BY THE ANDALUSIAN PRODUCTIVE SYSTEM

    Directory of Open Access Journals (Sweden)

    Manuel Alejandro Cardenete

    2012-01-01

    Full Text Available In this study we apply a multiplier decomposition methodology of a linear general equilibrium model based on the regional social accounting matrix to the Andalusian economy. The aim of this methodology is to separate the size of the different effects in terms of energy expenditure and total emissions generated by the whole productive system to satisfy the final demand of each branch of the Andalusian economy and the direct emissions generated to produce energy for each subsystem.

  9. T20QoL: an observational multicenter cohort study to evaluate the quality of life in HIV-patients treated with enfuvirtide (ENF, T-20 in combination with an optimized background therapy

    Directory of Open Access Journals (Sweden)

    R Bucciardini

    2008-09-01

    Full Text Available R Bucciardini1, M Massella1, A Corpolongo2, P Narciso2, V Fragola1, M Mirra1, S Donnini1, O Viganò3, S Costarelli4, V Tozzi21Istituto Superiore di Sanità, Rome, Italy; 2IRCCS L. Spallanzani, Rome, Italy; 3Ospedale L. Sacco, Milan, Italy; 4Spedali Civili di Brescia, Brescia, ItalyAim: To evaluate the impact of health-related quality of life (HRQoL enfuvirtide-based (ENF-based salvage regimens of treatment-experienced HIV patients, in an observational multicenter cohort study.Methods: HRQoL was measured in a cohort of 16 patients over a 6-month follow-up using 2 instruments: the ISSQoL (Istituto Superiore di Sanità Quality of Life, a recently validated HIV-specific questionnaire; the EQ-5D (EuroQol, a generic widely used instrument. ENF was given at standard dosage along with an optimized background regimen.Results: Most of HRQoL dimensions showed improvement in ENF-treated patients at the post-baseline time points. Social functioning was the only dimension showing a negative effect. Monthly care costs of antiretroviral drugs for HIV patients taking ENF plus an optimized background regimen were approximately €2,348 per patient-month (range €382– €2,940.Conclusion: Our results show that the addition of ENF to an optimized background salvage-HAART may positively affect HRQoL not only in clinical trials but also in a sample population of patients used in a routine clinical practice.Keywords: enfuvirtide, HRQoL, HIV

  10. Prognostic value of myocardial perfusion and ventricular function in a Japanese multicenter cohort study (J-ACCESS): the first-year total events and hard events

    OpenAIRE

    Nakajima, Kenichi; Kusuoka, Hideo; Nishimura, Shigeyuki; Yamashina, Akira; Nishimura, Tsunehiko

    2009-01-01

    Objective: To determine the prognostic value of myocardial ischemia, function and coronary risk factors on total and hard cardiac events using myocardial perfusion imaging in a Japanese population. Methods: A prospective cohort study was performed in 117 Japanese hospitals, each with a nuclear cardiology facility. A total of 4,031 patients with suspected or confirmed ischemic heart disease were registered. The patients were followed up for a year to investigate total and hard events, and thos...

  11. Multi-center feasibility study evaluating recruitment, variability in risk factors and biomarkers for a diet and cancer cohort in India

    OpenAIRE

    McAdams Mary J; Reddy K; Kapur Kavita; Graubard Barry I; Ramakrishnan Lakshmy; Morrissey Kerry; George Preethi S; Ferrucci Leah M; Shetty Hemali; Yurgalevitch Susan; Devasenapathy Niveditha; Daniel Carrie R; Sinha Rashmi; Rastogi Tanuja; Chatterjee Nilanjan

    2011-01-01

    Abstract Background India's population exhibits diverse dietary habits and chronic disease patterns. Nutritional epidemiologic studies in India are primarily of cross-sectional or case-control design and subject to biases, including differential recall of past diet. The aim of this feasibility study was to evaluate whether a diet-focused cohort study of cancer could be established in India, providing insight into potentially unique diet and lifestyle exposures. Methods Field staff contacted 7...

  12. Systematic evaluation of the clinical effects of supportive mistletoe treatment within chemo- and/or radiotherapy protocols and long-term mistletoe application in nonmetastatic colorectal carcinoma: multicenter, controlled, observational cohort study.

    Science.gov (United States)

    Friedel, Walter E; Matthes, Harald; Bock, Paul R; Zänker, Kurt S

    2009-01-01

    In Europe, patients with colorectal carcinoma (CRC) frequently receive mistletoe extracts to improve quality of life and survival. This study was designed to evaluate supportive treatment with mistletoe extract Iscador (ISC) in nonmetastatic CRC patients under routine clinical conditions and to create well-founded hypotheses for future prospective clinical studies. The design of a multicenter, controlled, retrospective, observational cohort study with parallel groups met the Good Epidemiological Practice rules. Anonymous unselected standardized data from eligible patients with surgically treated stage I-III CRC and adjuvant therapy (AT) or conventional aftercare were included. End points were adjuvant therapy-related adverse reactions (AT-ADRs), symptoms, and disease-free survival (DFS). The results were adjusted for confounder effects. Eight hundred four (429 ISC vs 375 control) CRC patients from 26 centers were observed for a median of 58 versus 51 months; the median ISC therapy lasted 52 months. ISC patients showed fewer AT-ADRs (19% vs 48%, p controls. ISC was well tolerated without life-threatening ADRs, drug interactions, or tumor enhancement. These results suggest a beneficial effect of supportive care ISC therapy within AT protocols and long-term ISC treatment in stage I-III CRC patients, particularly improvement in AT-ADRs and symptoms and possible extension of DFS. PMID:19883529

  13. Validation of Single Nucleotide Polymorphisms (SNPs) Associated with Acute Rejection in Kidney Transplant Recipients Using a Large Multi-Center Cohort

    Science.gov (United States)

    Oetting, William S.; Schladt, David P.; Leduc, Robert E.; Jacobson, Pamala A.; Guan, Weihua; Matas, Arthur J.; Israni, Ajay

    2011-01-01

    There have been numerous reports proposing a statistically significant association between a genetic variant, usually in the form of a single nucleotide polymorphism (SNP), and acute rejection (AR). Unfortunately, there are additional publications reporting a lack of association with AR when a different cohort of recipients was analyzed for the same SNP. The objective of this report was to attempt replication of these published finding in our own kidney allograft recipient cohort. We analyzed 23 genetic variants, previously reported to have a significant association with AR, using a cohort of 969 clinically well defined kidney transplant recipients. Only one SNP, rs6025 (Leiden mutation), within the coagulation factor V gene, showed a significant association with a p-value of 0.011 in a race adjusted analysis and 0.0003 in multiple variable analysis. An additional SNP, rs11706052 in IMPDH2, gave a modest p-value of 0.044 using multiple variable analysis which is not significant when multiple testing is taken into consideration. Our results suggest that careful validation of previously reported associations with AR is necessary and different strategies other than candidate gene studies can help to identify causative genetic variants associated with AR. PMID:21955043

  14. A retrospective, multi-center cohort study evaluating the severity- related effects of cerebrolysin treatment on clinical outcomes in traumatic brain injury.

    Science.gov (United States)

    Muresanu, Dafin F; Ciurea, Alexandru V; Gorgan, Radu M; Gheorghita, Eva; Florian, Stefan I; Stan, Horatiu; Blaga, Alin; Ianovici, Nicolai; Iencean, Stefan M; Turliuc, Dana; Davidescu, Horia B; Mihalache, Cornel; Brehar, Felix M; Mihaescu, Anca S; Mardare, Dinu C; Anghelescu, Aurelian; Chiparus, Carmen; Lapadat, Magdalena; Pruna, Viorel; Mohan, Dumitru; Costea, Constantin; Costea, Daniel; Palade, Claudiu; Bucur, Narcisa; Figueroa, Jesus; Alvarez, Anton

    2015-01-01

    Traumatic brain injury (TBI) is a leading cause of death and disability for which there is currently no effective drug therapy available. Because drugs targeting a single TBI pathological pathway have failed to show clinical efficacy to date, pleiotropic agents with effects on multiple mechanisms of secondary brain damage could represent an effective option to improve brain recovery and clinical outcome in TBI patients. In this multicenter retrospective study, we investigated severity-related efficacy and safety of the add-on therapy with two concentrations (20 ml/day or 30 ml/day) of Cerebrolysin (EVER Neuro Pharma, Austria) in TBI patients. Adjunctive treatment with Cerrebrolysin started within 48 hours after TBI and clinical outcomes were ranked according to the Glasgow Outcome Scale and the Modified Rankin Disability Score at 10 and 30 days post-TBI. Analyses of efficacy were performed separately for subgroups of patients with mild, moderate or severe TBI according to Glasgow Coma Scale scores at admission. Compared to standard medical care alone (control group), both doses of Cerebrolysin were associated with improved clinical outcome scores at 10 days post-TBI in mild patients and at 10 and 30 days in moderate and severe cases. A dose-dependent effect of Cerebrolysin on TBI recovery was supported by the dose-related differences and the significant correlations with treatment duration observed for outcome measures. The safety and tolerability of Cerebrolysin in TBI patients was very good. In conclusion, the results of this large retrospective study revealed that early Cerebrolysin treatment is safe and is associated to improved TBI outcome. PMID:25924999

  15. Peritonsillar abscess (PTA): clinical characteristics, microbiology, drug exposures and outcomes of a large multicenter cohort survey of 412 patients hospitalized in 13 French university hospitals.

    Science.gov (United States)

    Lepelletier, D; Pinaud, V; Le Conte, P; Bourigault, C; Asseray, N; Ballereau, F; Caillon, J; Ferron, C; Righini, C; Batard, E; Potel, G

    2016-05-01

    The aim of this study was to describe the epidemiology of hospitalized patients with peritonsillar abscess (PTA). We conducted a multicenter survey in 13 French university hospitals in 2009-2012 describing 412 patients. Median age was 29 year (range, 2-84) and current smoking habit was reported by 177 (43 %) patients. Most of the patients (92 %) had consulted a physician for sore throat within 10 days before admission for PTA diagnosis. Additional symptoms such as visible tonsil abnormalities (83 %), tender cervical adenopathy (57 %) and fever ≥ 38.5 °C (53 %) were also reported. A total of 65 % patients (269/412) reported recent systemic anti-inflammatory agents (AIAs) exposure by medical prescription (70 %), self-medication (22 %), or both (8 %); 61 % and 27 % reported recent exposure to antibiotic and topical treatments for sore throat, respectively. Non-steroidal AIAs were used most often (45 %), particularly arylpropionic derivatives. A rapid diagnosis antigen test (RDT) for Streptococcus pyogenes was performed in 70 (17 %) patients and was positive in 17 (24 %), of whom 9 (53 %) were exposed to AIAs and 14 (82 %) to antibiotics. To treat PTA, antibiotic therapy was given to 392 (95 %) patients. Of 333 antibiotic prescriptions, amoxicillin-clavulanic acid and metronidazole were the most prescribed antibiotics (42 and 17 %, respectively). Surgical drainage of the abscess was performed in 119 (29 %) cases and tonsillectomy in 75 (18 %) cases. The clinical outcome was favorable during the hospital stay in 404 (98 %) patients. In conclusion, patients with sore throat are often exposed to AIAs before PTA diagnosis, and antibiotic prescription was not often based on the RDT positivity. PMID:26942743

  16. Locomotor, cardiocirculatory and metabolic adaptations to training in Andalusian and Anglo-Arabian horses.

    Science.gov (United States)

    Muñoz, A; Santisteban, R; Rubio, M D; Agüera, E I; Escribano, B M; Castejón, F M

    1999-02-01

    The effects of two training programmes in 20 Andalusian and 12 Anglo-Arabian horses were evaluated by an increasing intensity work test at velocities of 4, 5, 6, 7 and 8 m sec(-1). Heart rate was monitored and blood samples were drawn at rest and after each velocity to analyse packed cell volume, haemoglobin concentration, plasma lactate and potassium levels. Furthermore, the programmes were video-taped and stride length, duration and frequency, stance (restraint and propulsion), swing phase durations and stride vertical component were measured. The training protocol of the Andalusian horses produced significant decreases in the cardiovascular, haematological and metabolic responses to exercise. Locomotory training adaptation consisted of an increased stride frequency and a reduced stride length and vertical stride component. The last variable was the limiting factor of stride length both before and after training in the Andalusian horses. A different training protocol for show-jumping competition in Anglo-Arabian horses failed to show significant differences in the studied parameters to the work test, although an increase in stride length at velocities of over 6 m sec(-1) was observed. Stride vertical component did not have an effect on the physiological response to exercise, either before or after training. PMID:10088708

  17. Multi-center feasibility study evaluating recruitment, variability in risk factors and biomarkers for a diet and cancer cohort in India

    Directory of Open Access Journals (Sweden)

    McAdams Mary J

    2011-05-01

    Full Text Available Abstract Background India's population exhibits diverse dietary habits and chronic disease patterns. Nutritional epidemiologic studies in India are primarily of cross-sectional or case-control design and subject to biases, including differential recall of past diet. The aim of this feasibility study was to evaluate whether a diet-focused cohort study of cancer could be established in India, providing insight into potentially unique diet and lifestyle exposures. Methods Field staff contacted 7,064 households within three regions of India (New Delhi, Mumbai, and Trivandrum and found 4,671 eligible adults aged 35-69 years. Participants completed interviewer-administered questionnaires (demographic, diet history, physical activity, medical/reproductive history, tobacco/alcohol use, and occupational history, and staff collected biological samples (blood, urine, and toenail clippings, anthropometric measurements (weight, standing and sitting height; waist, hip, and thigh circumference; triceps, sub-scapula and supra-patella skin fold, and blood pressure measurements. Results Eighty-eight percent of eligible subjects completed all questionnaires and 67% provided biological samples. Unique protein sources by region were fish in Trivandrum, dairy in New Delhi, and pulses (legumes in Mumbai. Consumption of meat, alcohol, fast food, and soft drinks was scarce in all three regions. A large percentage of the participants were centrally obese and had elevated blood glucose levels. New Delhi participants were also the least physically active and had elevated lipids levels, suggesting a high prevalence of metabolic syndrome. Conclusions A high percentage of participants complied with study procedures including biological sample collection. Epidemiologic expertise and sufficient infrastructure exists at these three sites in India to successfully carry out a modest sized population-based study; however, we identified some potential problems in conducting a cohort

  18. Clinical outcome of HIV-infected patients with sustained virologic response to antiretroviral therapy: long-term follow-up of a multicenter cohort.

    Directory of Open Access Journals (Sweden)

    Félix Gutierrez

    Full Text Available BACKGROUND: Limited information exists on long-term prognosis of patients with sustained virologic response to antiretroviral therapy. We aimed to assess predictors of unfavorable clinical outcome in patients who maintain viral suppression with HAART. METHODS: Using data collected from ten clinic-based cohorts in Spain, we selected all antiretroviral-naive adults who initiated HAART and maintained plasma HIV-1 RNA levels <500 copies/mL throughout follow-up. Factors associated with disease progression were determined by Cox proportional-hazards models. RESULTS: Of 2,613 patients who started HAART, 757 fulfilled the inclusion criteria. 61% of them initiated a protease inhibitor-based HAART regimen, 29.7% a nonnucleoside reverse-transcriptase inhibitor-based regimen, and 7.8% a triple-nucleoside regimen. During 2,556 person-years of follow-up, 22 (2.9% patients died (mortality rate 0.86 per 100 person-years, and 40 (5.3% died or developed a new AIDS-defining event. The most common causes of death were neoplasias and liver failure. Mortality was independently associated with a CD4-T cell response <50 cells/L after 12 months of HAART (adjusted hazard ratio [AHR], 4.26 [95% confidence interval {CI}, 1.68-10.83]; P = .002, and age at initiation of HAART (AHR, 1.06 per year; 95% CI, 1.02-1.09; P = .001. Initial antiretroviral regimen chosen was not associated with different risk of clinical progression. CONCLUSIONS: Patients with sustained virologic response on HAART have a low mortality rate over time. Long-term outcome of these patients is driven by immunologic response at the end of the first year of therapy and age at the time of HAART initiation, but not by the initial antiretroviral regimen selected.

  19. Motivation for Substance Use, Venue of Sexual Encounter, and Sexual Risk Behavior among Men who Have Sex with Men (MSM) in the Multicenter AIDS Cohort Study (MACS): Factor Analysis, and Global vs. Event-Level Generalized Linear Mixed Model (GLMM) Assessment Approach

    OpenAIRE

    Burrell, Earl Ryan

    2014-01-01

    We use factor analysis to explore motivations for substance use before and/or during sexual activity in order to identify underlying structure in response types. The sample included 1º, 2º, and 3º motivation responses of 1,012 seropositive and 1,084 seronegative participants enrolled in the Multicenter AIDS Cohort Study (MACS) seen between 2006 and 2010. We found a single common factor for all alcohol and substance use combinations that combines the social and sexual domains. We also identifi...

  20. Training needs assessment of andalusian teachers in educational digital resources authoring for virtual learning environments

    Directory of Open Access Journals (Sweden)

    José Javier Romero Díaz de la Guardia

    2012-12-01

    Full Text Available This research work has been conducted within the teacher training plan known as “Escuela TIC 2.0”, implemented by the Spanish Junta de Andalucía. The main aim is to obtain objective data regarding training needs for teachers in the autonomous region of Andalusia in terms of educational digital content authoring. To that end, we carried out a descriptive survey study on Andalusian teachers participating in teacher training courses on e-learning strategies that took place during the 2011- 2012 academic year.

  1. Opinions of Students Enrolled in an Andalusian Bilingual Program on Bilingualism and the Program Itself

    Directory of Open Access Journals (Sweden)

    Francisco Ramos Calvo

    2007-05-01

    Full Text Available The Regional Ministry of Education of the Autonomous Government of Andalusia, an autonomous community in the South of Spain, has established several bilingual programs to improve language proficiency of its student population. The programs, which undertake second languages as vehicular languages at the classroom, encourage student’s bilingualism, academic development and positive attitudes toward other groups. The following paper examines opinions given by a group of students enrolled in an Andalusian bilingual program about those matters. Students had different positive opinions on bilingualism as well as the program in general; however, they had some doubts over the intellectual and cognitive benefits of learning languages.

  2. Fat distribution and longitudinal anthropometric changes in HIV-infected men with and without clinical evidence of lipodystrophy and HIV-uninfected controls: A substudy of the Multicenter AIDS Cohort Study

    Directory of Open Access Journals (Sweden)

    Palella Frank J

    2009-05-01

    Full Text Available Abstract Background Fat abnormalities are common among HIV-infected persons, but few studies have compared regional body fat distribution, including visceral fat, in HIV-infected and HIV-uninfected persons and their subsequent trajectories in body composition over time. Methods Between 1999 and 2002, 33 men with clinical evidence of lipodystrophy (LIPO+, 23 HIV-infected men without clinical evidence of lipodytrophy (LIPO-, and 33 HIV-uninfected men were recruited from the four sites of the Multicenter AIDS Cohort Study (MACS. Participants underwent dual-energy x-ray absorptiometry, quantitative computerized tomography of the abdomen and thigh, and circumference measurements of the waist, hip and thigh. Circumference measurements at each semi-annual MACS visit between recruitment and 2008 were used to compare average annual anthropometric changes in the 3 groups. Results Body mass index (BMI was lower in LIPO+ men than in the LIPO- men and the HIV- uninfected controls (BMI: 23.6 ± 0.4 vs 26.8 ± 1.5 vs 28.7 ± 0.9 kg/m2, respectively, p 2 compared to the LIPO- men (129 ± 12 cm2, p = 0.03 and the HIV-uninfected group (133 ± 11 cm2, p = 0.07. Subcutaneous adipose tissue (thigh, abdomen and total extremity fat were less in the HIV-infected men (LIPO+ and LIPO- than in the HIV-uninfected men. Over an average of 6 years of follow-up, waist circumference increased at a faster rate in LIPO+ group, compared to the LIPO- men (0.51 cm/year vs 0.08 cm/year, p = 0.02 and HIV-uninfected control men (0.21 cm/year, p = 0.06. The annual changes in hip and thigh circumferences were similar in all three groups Conclusion Subcutaneous lipoatrophy was observed in HIV-infected patients, even those without clinical evidence of lipodystrophy, compared to age-matched HIV-uninfected men. Despite markedly lower BMI, HIV-infected men with lipodystrophy had a similar amount of VAT as HIV-uninfected men and tended to have more rapid increases in waist circumference over 6

  3. Y-STR genetic diversity in autochthonous Andalusians from Huelva and Granada provinces (Spain).

    Science.gov (United States)

    Ambrosio, Beatriz; Novelletto, Andrea; Hernandez, Candela; Dugoujon, Jean Michel; Fortes-Lima, César; Rodriguez, Juan Nicolás; Calderon, Rosario

    2012-03-01

    Seventeen Y-chromosomal short tandem repeats (STRs) were analyzed in 347 healthy, unrelated, autochthonous males from the Andalusian provinces of Huelva (N=167) and Granada (N=180). AmpFlSTR Y-filer PCR Amplification kit (Applied Biosystems) was used to type the Y-STR markers. A total of 156 and 166 different haplotypes for the 17 Y-STR set were detected in Huelva, and Granada, respectively. The same haplotype diversity was found for both samples (0.998±0.001), and the overall discrimination capacity was 0.904. The most common minimal haplotype (DYS19, DYS389 I, DYS389 II, DYS390, DYS391, DYS392, DYS393) in both subpopulations was 14-13-16-24-11-13-13, which is also the most frequent haplotype among Atlantic European populations. Comparison analysis using pairwise R(ST) values and Analysis of Molecular Variance (AMOVA) revealed a significant genetic distance between our Andalusian samples and other ones from the northern Iberian fringe (including Basque and Pyrenean populations). However, results from the multi-dimensional scaling analysis (MDS) yielded a well-defined group of Iberian populations separated from the other Mediterranean clusters observed. PMID:21664894

  4. Multicenter dizygotic twin cohort study confirms two linkage susceptibility loci for body mass index at 3q29 and 7q36 and identifies three further potential novel loci

    DEFF Research Database (Denmark)

    Kettunen, J; Perola, M; Martin, N G;

    2009-01-01

    odds score (MLOD) 2.6 and 2.4, respectively). Two individual cohorts showed strong evidence independently for three additional loci: 16q23 (MLOD=3.7) and 2p24 (MLOD=3.4) in the Dutch cohort and 20q13 (MLOD=3.2) in the Finnish cohort. CONCLUSION: Linkage analysis of the combined data in this large twin...

  5. The future of environmental health in Andalusian Region: suitability of improvement El futuro de la sanidad ambiental en Andalucía: oportunidades de mejora

    OpenAIRE

    Joaquín Jesús Gámez de la Hoz; Alicia Martínez Martínez; José Antonio Ferreras Iglesias

    2008-01-01

    In the present article is presented a portrait of the situation of the environmental health in the administration of Andalusian Goverment; are analyzed implanted management formulations and we believe a reflection space on the professional exercise and the course begun with the organizational process in the Andalusian public health. The public health system has not undergone reconstruction from the process of transferences from the State towards the autonomous Communities. We identified the ...

  6. ANALYSIS OF "BEST PRACTICES" OF E-LEARNING IN ANDALUSIAN UNIVERSITIES

    Directory of Open Access Journals (Sweden)

    Julio Cabero Almenara

    2010-02-01

    Full Text Available This article provides the results of the analysis of "best practices" of thirty teachers of different Andalusian Universities. For the collection of data we have been used three instruments: biogram, individualized interviews and observation of materials. These teachers have a positive attitude towards e-learning, working in groups and carry more than 2 years teaching with (together the face to face. They consider this training as a high help to students because of the high volume of available material, application flexibility, the possibility of consultation and the treatment is more personal. Moreover, these teachers pointed out the amount of time and effort required for the preparation and updating of materials, and also here poor training for teaching and educational use, that is remedied by themselves. The materials used are is adecuated in the technical, teaching and in the communication way.

  7. Management and outcomes in digestive cancer surgery: design and initial results of a multicenter cohort study Proceso asistencial y resultados en la cirugía de cáncer digestivo: diseño y resultados iniciales de un estudio de cohortes multicéntrico

    Directory of Open Access Journals (Sweden)

    M. Espallargues

    2009-10-01

    Full Text Available Background: most studies that analyze the influence of structure factors on clinical outcomes are retrospective, based on clinical-administrative databases, and mainly focusing on surgical volume. Objective: to study variations in the process and outcomes of oncologic surgery for esophagus, stomach, pancreas, liver metastases and rectum cancers in Catalonia, as well as the factors associated with these variations. Patients and method: a retrospective (2002 and prospective (2003-05 multicenter cohort study. Data forms were designed to collect patient, process, and care outcome characteristics before surgery, at hospital discharge, and at 3 and 6 months after discharge. Main outcome measures were hospital and follow-up mortality, complications, re-interventions, and relapse rates. Results: 49 hospitals (80% participated in the retrospective phase, 44 of which (90% also participated in the prospective phase: 3,038 patients (98% were included. No differences were observed in the profile of operated patients according to hospital level of complexity, but clinical-pathological staging and other functional status variables could not be assessed because of over 20% of missing values. There was significant variability in the volume of interventions as well as in certain aspects of the healthcare process depending on type of cancer and center complexity. High rates of esophageal cancer mortality (18.2% at discharge, 27.3% at 6 months and of complications and re-interventions for all cancers assessed, especially rectal cancer (18.4% re-interventions at 6 months, were identified. Conclusions: the study of the variability identified will require adequate risk-adjustment and should take into account different structure factors. It is necessary that information included in medical records be improved.Antecedentes: la mayoría de estudios que analizan la influencia de factores de estructura sobre los resultados son retrospectivos, realizados con bases de datos

  8. Performance of the classification criteria for early rheumatoid arthritis in a multi-center cohort%早期类风湿关节炎分类标准的全国多中心临床验证

    Institute of Scientific and Technical Information of China (English)

    叶华; 苏茵; 李茹; 赵金霞; 刘湘源; 梅轶芳; 张志毅; 郭嘉隆; 毕黎琦

    2014-01-01

    目的 多中心验证并比较早期RA (ERA)分类标准与1987年ACR和2010年ACR/EULAR分类标准在病程≤1年的ERA诊断中的敏感性和特异性.方法 按照国际通用的标准验证方法,入选病程≤1年,年龄>18岁,至少有1个以上部位关节炎的患者,详细记录发病情况,包括关节肿胀部位、持续时间、对称性、晨僵时间、皮下结节以及伴随症状等,检测其血清中抗CCP抗体、RF、ESR以及CRP等指标,并记录关节影像学改变的特点,经2名风湿科专科医师进行临床诊断,未确诊的患者每3个,月随访1次,共随访1年.比较ERA标准和1987年ACR以及2010年ACR/EULAR标准在ERA分类诊断中的敏感性和特异性.组间比较采用X2检验,敏感性和特异性比较采用Mc Nemar检验,阳性预测值比较采用Score检验.结果 ①共入组患者271例,1年随访结束时确诊病例256例,其中RA 120例,非RA136例;未确诊病例15例.②ERA标准的敏感性(76.7%)略高于2010年标准(70.0%),差异无统计学意义(P=0.115);但2010年标准(70.0%)和ERA标准(76.7%)的敏感性均明显高于1987年标准(51.7%),差异有统计学意义(x2=11.524,P<0.01;x2=26.471,P<0.01).ERA标准、2010年标准和1987年标准的特异性相似,分别为83.8%、83.8%和86.8%.结论 ERA分类标准在ERA诊断中的敏感性稍高于2010年ACR/EULAR分类标准,明显高于1987年ACR分类标准;3个标准在ERA诊断中的特异性相当,但ERA标准更为简单实用,可用于ERA的临床诊断.%Objective To evaluate the classification criteria for early rheumatoid arthritis (ERA) in a multi-center cohort,and compare the specificity and sensitivity among ERA criteria,1987 ACR criteria and 2010 ACR/EULAR criteria.Methods Patients who had arthritic complaints with disease duration no more than 1 year,and age more than 18 years were enrolled.The clinical and laboratory parameters were recorded.The patients were diagnosed by 2 experienced rheumatologists based

  9. Chemometric study of Andalusian extra virgin olive oils Raman spectra: Qualitative and quantitative information.

    Science.gov (United States)

    Sánchez-López, E; Sánchez-Rodríguez, M I; Marinas, A; Marinas, J M; Urbano, F J; Caridad, J M; Moalem, M

    2016-08-15

    Authentication of extra virgin olive oil (EVOO) is an important topic for olive oil industry. The fraudulent practices in this sector are a major problem affecting both producers and consumers. This study analyzes the capability of FT-Raman combined with chemometric treatments of prediction of the fatty acid contents (quantitative information), using gas chromatography as the reference technique, and classification of diverse EVOOs as a function of the harvest year, olive variety, geographical origin and Andalusian PDO (qualitative information). The optimal number of PLS components that summarizes the spectral information was introduced progressively. For the estimation of the fatty acid composition, the lowest error (both in fitting and prediction) corresponded to MUFA, followed by SAFA and PUFA though such errors were close to zero in all cases. As regards the qualitative variables, discriminant analysis allowed a correct classification of 94.3%, 84.0%, 89.0% and 86.6% of samples for harvest year, olive variety, geographical origin and PDO, respectively. PMID:27260451

  10. Staged Memories: Spanish Drama and Cinema, Andalusian Identity and Flamenco Music in Argentina and Mexico

    Directory of Open Access Journals (Sweden)

    Emilio J. Gallardo-Saborido

    2015-09-01

    Full Text Available Culture, particularly cinema, drama and music, played a key role in order to keep and reinforce the identity of Spanish migrants in Argentina and Mexico during the first part of the 20th century. For decades, these countries had received thousands of migrants from Spain, and by the period following the Spanish Civil War (1936-1939 a notable colony of them settled in Buenos Aires and Mexico City. At the same time, several artists arrived to these places escaping from the war, political repression or, simply, looking for new work opportunities. For instance, famous singers, actors and flamenco players and dancers (v.g. Miguel de Molina, Angelillo, Niño de Utrera, or Sabicas achieved overwhelming successes in Buenos Aires and Mexico City’s theatres. Even more, they created a parallel Spanish stardom abroad. Hence, this proposal summarizes the contribution of some of these artists and the fusion between theatre and cinema, and typical Andalusian music as flamenco to preserve and evoke the collective memory of such a faraway motherland. Since Andalusia (the Southern region of Spain and its culture acted as a metonymic resource to represent that country during that period, migrants from different regions could recognize a common notion of the Spanish identity in them. In this sense, ‘home’ could be staged, remembered, fictionalized and, obviously, idealized.

  11. Academic spin-offs incubation strategies: the case of the Andalusian region

    Directory of Open Access Journals (Sweden)

    F. Rafael Cáceres Carrasco

    2015-10-01

    Full Text Available The objective of this paper is to analyze the incubation strategies developed in the universities of Andalusia, a relatively low-income region of Spain, to promote the creation of university spin-offs. These strategies are also compared to the incubation models noted in the literature. The performance of the university spin-offs created and its relation to the incubation strategies developed by the university are also analysed. The analysis is based on data from a survey of nine public universities that carry out strategies for the promotion of university spin-offs. The result of the analysis shows that university spin-off incubation strategies in Andalusia present specific characteristics not covered by certain models that are well-known in the literature on innovation. Then, a new stage in the process of the university spin-off incubation is proposed. We consider it to be a pre-strategic stage to the academic spin-off incubation strategies. The analysis also finds certain environmental factors associated to those spin-offs promoted by Andalusian universities that achieve the highest level of performance. This result suggests that previous to making any decision involving investment into developing incubation strategies, universities should gauge whether they have sufficient resources and the possibilities of connecting with a Technology Park.

  12. Macroscopical morphology of accelerated deterioration of same petreous materials in Andalusian-Spain monuments

    Directory of Open Access Journals (Sweden)

    Alcalde, M.

    1990-06-01

    Full Text Available Several lithotypes used in diverse Andalusian monuments have undergone laboratory experiments of salt crystallization and within controlled environments. The indicators of deterioration that appear are justified from the point of view of the type of experiment and the lithotype, and compared with those found in the monuments. The capillarity with forced ventilation experiment, with an original and simple design, is of special signification. With wich the typical desquamations in the marbles of the Cathedral of Cádiz are reproduced.

    Varios litotipos utilizados en diversos monumentos andaluces han sido sometidos a experiencias de laboratorio de cristalización de sales y en atmósferas controladas. Los indicadores de alteración que aparecen son justificados desde el punto de vista del tipo de experiencia y del litotipo, y comparados con aquéllos encontrados en los monumentos. De especial significación es la experiencia de capilaridad con ventilación forzada, de diseño sencillo y original, con la que se reproducen las tipleas descamaciones de los mármoles de la Catedral de Cádiz.

  13. Multicenter data acquisition made easy

    DEFF Research Database (Denmark)

    Rosenberg, Jacob; Henriksen, Nadia Abdelaal; Jørgensen, Lars Nannestad

    2010-01-01

    The process for data collection in multicenter trials may be troublesome and expensive. We report our experience with the spreadsheet function in Googledocs for this purpose.......The process for data collection in multicenter trials may be troublesome and expensive. We report our experience with the spreadsheet function in Googledocs for this purpose....

  14. Education and planetary citizenship. Conceptions of the students participants in educational Andalusian programs

    Directory of Open Access Journals (Sweden)

    Olga Moreno Fernández

    2015-05-01

    Full Text Available Society and Education seem closer ties in recent decades due to various social factors that are now changing the world order and the emerging new educational approaches for this century. Changes that make us reflect on the need to address citizenship not center don the local, but addressing a broader spectrum, forming a planetary citizenship review relevant, participatory, dialogical, holistic and equitable where every living being and play a key role. This planetary citizenship must be approached from the school with the intention that perceptible changes in the social fabric. Conclusions lead us to consider the need for education for a "global citizenship" or "global citizenship" as a challenge to address. This research aims to provide information and ideas on the importance of educational programs that promote citizen participation in our students have the skills to promote active citizenship derived. On the other hand, is a first approach to some of the educational programs offered from different Andalusian (Spain government and incorporated into the educational context in school. The results for educational programs “Eco-School”, “Youth Parliament” and “Sure you move” from the point of view of the student presents particular. As we set goals detecting conceptions of the sample with respect to the study topics that concern us as well as check if education for planetary citizenship is present in these programs. Data collection, which has its focus on a qualitative methodology, was carried out from open-ended questionnaire, semi-structured interviews and focus groups. Data were subsequently treated with analysis software Atlas.ti (version 6.2. Processing and analysis have finalized how these educational programs encourage student participation in their daily lives and in the community where they live, and the vision of "planetary citizenship" they have and their ability to relate local issues relevant to global problems. And is

  15. Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state - A prospective multicenter randomized controlled clinical trial using a comprehensive cohort design

    Directory of Open Access Journals (Sweden)

    Wendt Thomas G

    2009-12-01

    Full Text Available Abstract Background Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2 and concomitant ipsilateral metastasis of a single lymph node (pN1, which would provide a basis for a general treatment recommendation. Methods/Design The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT. As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation. Since patients with small tumor (T1/T2 but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread, Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module, and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve

  16. The Andalusian elections of 2012 in the national press: Analysis of the coverage of Abc, El Mundo and El País

    Directory of Open Access Journals (Sweden)

    P Farias Batlle

    2013-04-01

    Full Text Available Introduction. This article analyses the coverage of the Andalusian elections campaign of 25 March, 2012, by the Andalusian editions of three Spanish national newspapers: Abc, El Mundo and El País. Objectives.To determine the similarities and differences in the treatment given to the electionsby thesenewspapers;to establish the degree of convergence between the agenda of these newspapers and the agenda of the contending parties; to characterise the presence of the political leaders; and to identify the predominant frames. Methods.Content analysis focused on sixteen items related to the location, production features and content of the 497 electionnews items published by the sample of newspapers. Conclusions.There wasa predominance of regional issues in the coverage of the elections campaign; there was a low presence of interpretive and analytical elements; and there was a predominance of strategic and game frames in the coverage of the elections campaign.

  17. The role of ancillary benefits on the value of agricultural soils carbon sequestration programmes: Evidence from a latent class approach to Andalusian olive groves

    OpenAIRE

    Rodriguez, Macario; ESPINOSA GODED MARIA; BARREIRO-HURLÉ Jesús

    2014-01-01

    Agriculture is a key sector for climate change mitigation strategies due to its CO2 sequestration potential. However, in order to increase mitigation changes in current crop and land management are required, which in many cases imply additional costs to farmers. Thus, this research assesses society's willingness to pay using a discrete choice analysis for a soil management programme in Andalusian olive groves identifying different groups based on preference heterogeneity. We identify thre...

  18. Virologic and immunologic effectiveness of darunavir-based salvage therapy in HIV-1-infected adults in a Brazilian clinical practice setting: results of a multicenter and retrospective cohort study

    Directory of Open Access Journals (Sweden)

    Karina Mota Ribeiro

    2014-01-01

    Full Text Available Background: Darunavir has been proven efficacious for antiretroviral-experienced HIV-1-infected patients in randomized trials. However, effectiveness of darunavir-based salvage therapy is understudied in routine care in Brazil. Methods: Retrospective cohort study of HIV-1-infected patients from three public referral centers in Belo Horizonte, who received a darunavir-based therapy between 2008 and 2010, after virologic failure. Primary endpoint was the proportion of patients with viral load <50 copies/mL at week 48. Change in CD4 cell count was also evaluated. Outcome measures were analyzed on an intent-to-treat basis applied to observational studies. Sensitivity analysis was conducted to evaluate the impact of missing data at week 48. Predictors of virologic failure were examined using rare-event, finite sample, bias-corrected logistic regression. Results: Among 108 patients, the median age was 44.2 years, and 72.2% were male. They had long-standing HIV-1 infection (median 11.6 years and advanced disease (76.9% had an AIDS-defining event. All patients had previously received protease inhibitors and nucleoside reverse transcriptase inhibitors, 75% nonnucleoside reverse transcriptase inhibitors, and 4.6% enfuvirtide. The median length of protease inhibitor use was 8.9 years, and 90.8% of patients had prior exposure to unboosted protease inhibitor. Genotypic resistance profile showed a median of three primary protease inhibitor mutations and 10.2% had three or more darunavir resistance-associated mutations. Virologic success at week 48 was achieved by 78.7% (95% CI = 69.7–86% of patients and mean CD4 cell count increase from baseline was 131.5 cells/μL (95% CI = 103.4–159.6. In multiple logistic regression analysis, higher baseline viral load (RR = 1.04 per 10,000 copies/mL increase; 95% CI = 1.01–1.09 and higher number of darunavir resistance-associated mutations (RR = 1.23 per each; 95% CI = 0.95–1.48 were independently associated with

  19. Rationale and design of a multicenter prospective cohort study for the eVALuation and monitoring of HPV infections and relATEd cervical diseases in high-risk women (VALHIDATE study

    Directory of Open Access Journals (Sweden)

    Orlando Giovanna

    2012-05-01

    Full Text Available Abstract Background Pap screening, an effective method for cervical cancer prevention, is now supported by molecular human papillomavirus (HPV testing. Recently commercialised preventive vaccines also provide new tools for the primary prevention of cervical cancer. To determine appropriate prevention strategies, the Health General Direction, Lombardy Region, funded a project that aims to characterize and monitor HPV infections and related cervical diseases in high-risk women. Methods/design VALHIDATE is a 5-year multicentre open prospective cohort study. It will recruit 7000 consenting women aged 13–65 years to provide information about the local biomolecular epidemiology of HPV infection and cervical diseases in high-risk women recruited from nine clinical centres and one faith-based organisation. The study will estimate the overall and type-specific prevalence of HPV infection and cervical abnormalities. It also aims to compare standard Pap screening with biomolecular screening, and to assist in the design of targeted regional prevention programs directed specifically at high-risk groups. Three groups of high-risk women: 1000 HIV-infected women (aged 26–65 years, 1000 recent migrant women (aged 26–65 years and 3000 young women (aged 13–26 years and 1 control group: 2000 women (aged 26–45 years attending a spontaneous screening program, will be recruited. Sample sizes will be revised after the first year. Adult participants will undergo conventional cervical cytology, HPV DNA screening and genotyping. Paediatric participants will undergo HPV DNA testing and genotyping of urine samples. HPV DNA, cytological abnormalities and HPV types will be analysed according to demographic, epidemiological, behavioural, and clinical data collected in an electronic case report form. Overall and stratified prevalences will be estimated to analyse the associations between HPV infection and selected characteristics. Logistic regression models

  20. Rationale and design of a multicenter prospective cohort study for the eVALuation and monitoring of HPV infections and relATEd cervical diseases in high-risk women (VALHIDATE study)

    International Nuclear Information System (INIS)

    Pap screening, an effective method for cervical cancer prevention, is now supported by molecular human papillomavirus (HPV) testing. Recently commercialised preventive vaccines also provide new tools for the primary prevention of cervical cancer. To determine appropriate prevention strategies, the Health General Direction, Lombardy Region, funded a project that aims to characterize and monitor HPV infections and related cervical diseases in high-risk women. VALHIDATE is a 5-year multicentre open prospective cohort study. It will recruit 7000 consenting women aged 13–65 years to provide information about the local biomolecular epidemiology of HPV infection and cervical diseases in high-risk women recruited from nine clinical centres and one faith-based organisation. The study will estimate the overall and type-specific prevalence of HPV infection and cervical abnormalities. It also aims to compare standard Pap screening with biomolecular screening, and to assist in the design of targeted regional prevention programs directed specifically at high-risk groups. Three groups of high-risk women: 1000 HIV-infected women (aged 26–65 years), 1000 recent migrant women (aged 26–65 years) and 3000 young women (aged 13–26 years) and 1 control group: 2000 women (aged 26–45 years) attending a spontaneous screening program, will be recruited. Sample sizes will be revised after the first year. Adult participants will undergo conventional cervical cytology, HPV DNA screening and genotyping. Paediatric participants will undergo HPV DNA testing and genotyping of urine samples. HPV DNA, cytological abnormalities and HPV types will be analysed according to demographic, epidemiological, behavioural, and clinical data collected in an electronic case report form. Overall and stratified prevalences will be estimated to analyse the associations between HPV infection and selected characteristics. Logistic regression models will be used to estimate crude and adjusted odds ratios. Cox

  1. The MANGUA Project: A Population-Based HIV Cohort in Guatemala

    OpenAIRE

    Juan Ignacio García; Blanca Samayoa; Meritxell Sabidó; Luis Alberto Prieto; Mikhail Nikiforov; Rodolfo Pinzón; Luis Roberto Santa Marina de León; José Fernando Ortiz; Ernesto Ponce; Carlos Rodolfo Mejía; Eduardo Arathoon; Jordi Casabona; The Mangua Cohort Study Group

    2015-01-01

    Introduction. The MANGUA cohort is an ongoing multicenter, observational study of people living with HIV/AIDS in Guatemala. The cohort is based on the MANGUA application which is an electronic database to capture essential data from the medical records of HIV patients in care. Methods. The cohort enrolls HIV-positive adults ≥16 years of age. A predefined set of sociodemographic, behavioral, clinical, and laboratory data are registered at entry to the cohort study. Results. As of October 1st, ...

  2. Lymphoma Immune Reconstitution Inflammatory Syndrome in the Center for AIDS Research Network of Integrated Clinical Systems Cohort

    OpenAIRE

    Gopal, Satish; Patel, Monita R.; Achenbach, Chad J; Yanik, Elizabeth L.; Cole, Stephen R.; Napravnik, Sonia; Burkholder, Greer A.; Mathews, W. Christopher; Rodriguez, Benigno; Deeks, Steven G.; Mayer, Kenneth H.; Moore, Richard D.; Kitahata, Mari M.; Richards, Kristy L.; Eron, Joseph J.

    2014-01-01

    In a multicenter cohort, unmasking immune reconstitution inflammatory syndrome (IRIS) was observed in 12% of HIV-associated lymphomas. Presentation and survival for lymphoma IRIS were similar to non-IRIS, with possibly increased early mortality among IRIS cases.

  3. Nested Cohort

    Science.gov (United States)

    NestedCohort is an R software package for fitting Kaplan-Meier and Cox Models to estimate standardized survival and attributable risks for studies where covariates of interest are observed on only a sample of the cohort.

  4. [Use of customer relationship management to improve healthcare for citizens. The 24h Andalusian Health Service: Healthline].

    Science.gov (United States)

    Quero, Manuel; Ramos, María Belén; López, Wilfredo; Cubillas, Juan José; González, José María; Castillo, José Luis

    2016-01-01

    Salud Responde (in English: Healthline) is a Health Service and Information Centre of the taxpayer-funded Andalusian Health System (AHS) that offers a Telephone Health Advisory Service called SA24h, among other services. The main objective of SA24h is to inform and advise citizens on health issues and the available health resources of the AHS. SA24h has a Customer Relationship Management information technology tool that organises information at various levels of specialization. Depending on the difficulty of the query, the citizen is attended by professionals with distinct profiles, providing a consensual response within the professionals working within Salud Responde or within other healthcare levels of the AHS. SA24h provided responses to 757,168 patient queries from late 2008 to the end of 01/12/2015. A total of 9.38% of the consultations were resolved by the non-health professionals working at Salud Responde. The remaining 84.07% were resolved by health staff. A total of 6.5% of users were referred to accident and emergency facilities while 88.77% did not need to attend their general practitioner within the next 24hours, thus avoiding unnecessary visits to health care facilities. PMID:26900101

  5. Inter-rater reliability of healthcare professional skills' portfolio assessments: The Andalusian Agency for Healthcare Quality model

    Directory of Open Access Journals (Sweden)

    Antonio Almuedo-Paz

    2014-07-01

    Full Text Available This study aims to determine the reliability of assessment criteria used for a portfolio at the Andalusian Agency for Healthcare Quality (ACSA. Data: all competences certification processes, regardless of their discipline. Period: 2010-2011. Three types of tests are used: 368 certificates, 17,895 reports and 22,642 clinical practice reports (N = 3,010 candidates. The tests were evaluated in pairs by the ACSA team of raters using two categories: valid and invalid. Results: The percentage agreement in assessments of certificates was 89,9%, while for the reports of clinical practice was 85,1 % and for clinical practice reports was 81,7%. The inter-rater agreement coefficients (kappa ranged from 0,468 to 0,711. Discussion: The results of this study show that the inter-rater reliability of assessments varies from fair to good. Compared with other similar studies, the results put the reliability of the model in a comfortable position. Among the improvements incorporated, progressive automation of evaluations must be highlighted.

  6. First results from Be-7 soil erosion tracer application on cultivated field plots in the Andalusian Marl landscape

    Science.gov (United States)

    Baumgart, Philipp

    2014-05-01

    Within the last 25 years the cosmogenic nuclide Beryllium-7 was successfully established as a suitable tracer element to detect fine scaled surface changes in a very precise way. Particularly soil erosion rates from single precipitation events were in the focus of different studies due to the short radioactive half-life of the Be-7 isotope. High sorption at topmost soil particles and immobility at given pH-values enable fine-scaled erosion modelling down to 2 mm increments. But coming up to the scale of reality, which loss of material (due to single precipitation events) can we expect in the interill sector on cultivated field plots? Further in such a highly sensitive landscape like the Andalusian Marl? First Be-7 results from two differently cultivated slope plots (1.000 m2 each) with different geological background were presented due to a single precipitation event in march 2013. Moreover, challenging limitations of the fine increment, site-dependent soil collection were discussed.

  7. Cohort Coefficients

    DEFF Research Database (Denmark)

    Kristensen, Gustav

    2013-01-01

    Cohorts are the aggregate of individuals who experience the same event within the same time interval. Cohorts can be based on people born in a given year, for example in 1940 or within a span of years, e.g. born in 1940-1944. The year of birth is here the defining event for cohorts. The health di...

  8. Early Holocenic and Historic mtDNA African Signatures in the Iberian Peninsula: The Andalusian Region as a Paradigm.

    Directory of Open Access Journals (Sweden)

    Candela L Hernández

    Full Text Available Determining the timing, identity and direction of migrations in the Mediterranean Basin, the role of "migratory routes" in and among regions of Africa, Europe and Asia, and the effects of sex-specific behaviors of population movements have important implications for our understanding of the present human genetic diversity. A crucial component of the Mediterranean world is its westernmost region. Clear features of transcontinental ancient contacts between North African and Iberian populations surrounding the maritime region of Gibraltar Strait have been identified from archeological data. The attempt to discern origin and dates of migration between close geographically related regions has been a challenge in the field of uniparental-based population genetics. Mitochondrial DNA (mtDNA studies have been focused on surveying the H1, H3 and V lineages when trying to ascertain north-south migrations, and U6 and L in the opposite direction, assuming that those lineages are good proxies for the ancestry of each side of the Mediterranean. To this end, in the present work we have screened entire mtDNA sequences belonging to U6, M1 and L haplogroups in Andalusians--from Huelva and Granada provinces--and Moroccan Berbers. We present here pioneer data and interpretations on the role of NW Africa and the Iberian Peninsula regarding the time of origin, number of founders and expansion directions of these specific markers. The estimated entrance of the North African U6 lineages into Iberia at 10 ky correlates well with other L African clades, indicating that U6 and some L lineages moved together from Africa to Iberia in the Early Holocene. Still, founder analysis highlights that the high sharing of lineages between North Africa and Iberia results from a complex process continued through time, impairing simplistic interpretations. In particular, our work supports the existence of an ancient, frequently denied, bridge connecting the Maghreb and Andalusia.

  9. Mixed connective tissue disease: Results from a nation-wide multicenter survey of Norwegian patients.

    OpenAIRE

    2013-01-01

    The Norwegian mixed connective tissue disease (MCTD) cohort study was the first nationwide study of this rare autoimmune, systemic connective tissue disease (CTD), which was first defined only four decades ago (3). This nation-wide, multicenter study involved the Departments of Rheumatology in Norway. The inclusion criteria were: age = 18 years; a clinical diagnosis of MCTD; documented high titer serum anti-ribonucleoprotein antibody test; fulfillment of at least one of the three most used di...

  10. Delays in Appropriate Antibiotic Therapy for Gram-Negative Bloodstream Infections: A Multicenter, Community Hospital Study

    OpenAIRE

    Moehring, Rebekah W.; Richard Sloane; Chen, Luke F.; Smathers, Emily C.; Schmader, Kenneth E.; Fowler, Vance G.; Weber, David J.; Sexton, Daniel J.; Anderson, Deverick J.

    2013-01-01

    BACKGROUND: Gram-negative bacterial bloodstream infection (BSI) is a serious condition with estimated 30% mortality. Clinical outcomes for patients with severe infections improve when antibiotics are appropriately chosen and given early. The objective of this study was to estimate the association of prior healthcare exposure on time to appropriate antibiotic therapy in patients with gram-negative BSI. METHOD: We performed a multicenter cohort study of adult, hospitalized patients with gram-ne...

  11. Regional Gray Matter Atrophy in Relapsing Remitting Multiple Sclerosis: Baseline Analysis of Multi-Center Data

    OpenAIRE

    Datta, Sushmita; Staewen, Terrell D.; Cofield, Stacy S.; Cutter, Gary R.; Lublin, Fred D; Wolinsky, Jerry S.; Narayana, Ponnada A.; ,

    2015-01-01

    Regional gray matter (GM) atrophy in multiple sclerosis (MS) at disease onset and its temporal variation can provide objective information regarding disease evolution. An automated pipeline for estimating atrophy of various GM structures was developed using tensor based morphometry (TBM) and implemented on a multi-center sub-cohort of 1008 relapsing remitting MS (RRMS) patients enrolled in a Phase 3 clinical trial. Four hundred age and gender matched healthy controls were used for comparison....

  12. Multicenter Study of High-Dose Daptomycin for Treatment of Enterococcal Infections

    OpenAIRE

    Casapao, Anthony M.; Kullar, Ravina; Davis, Susan L.; Levine, Donald P.; Zhao, Jing J.; Potoski, Brian A.; Goff, Debra A.; Crank, Christopher W.; Segreti, John; Sakoulas, George; Cosgrove, Sara E.; Rybak, Michael J.

    2013-01-01

    Enterococci are among the leading pathogens isolated in hospital-acquired infections. Current antimicrobial options for vancomycin-resistant enterococci (VRE) are limited. Prior data suggest that daptomycin at >6 mg/kg of body weight/day may be used to treat enterococcal infections. We retrospectively evaluated the effectiveness and safety of high-dose daptomycin (HD-daptomycin) therapy (>6 mg/kg) in a multicenter cohort of adult patients with enterococcal infections to describe the character...

  13. Process for development of multicenter urodynamic studies

    OpenAIRE

    NAGER, Charles W.; Albo, Michael E.; FitzGerald, Mary P; McDermott, Susan M.; Kraus, Stephen; Holly E. Richter; Zimmern, Philippe

    2007-01-01

    OBJECTIVES To describe our experiences with a continuous quality improvement process for the standardization of multicenter urodynamic studies (UDSs) in a multi-institutional network. Multicenter UDSs can have considerable variations in testing procedures, training, equipment, and reviewer biases. METHODS A quality control process was developed that included protocol development, certification of modynamic testers, central review to assess compliance with protocol and ...

  14. Birth cohorts

    DEFF Research Database (Denmark)

    Andersen, Anne-Marie Nybo; Madsen, Mia

    2009-01-01

    ; provides practical guidance on how to set-up and maintain birth cohorts for completing family-based studies in life course epidemiology; describes how to undertake appropriate statistical analyses of family-based studies and correctly interpret results from these analyses; and provides examples that...

  15. A Global Perspective on the Outcomes of Surgical Decompression in Patients With Cervical Spondylotic Myelopathy: Results From the Prospective Multicenter AOSpine International Study on 479 Patients

    NARCIS (Netherlands)

    Fehlings, M.G.; Ibrahim, A.; Tetreault, L.; Albanese, V.; Alvarado, M.; Arnold, P.; Barbagallo, G.; Bartels, R.H.; Bolger, C.; Defino, H.; Kale, S.; Massicotte, E.; Moraes, O.; Scerrati, M.; Tan, G.; Tanaka, M.; Toyone, T.; Yukawa, Y.; Zhou, Q.; Zileli, M.; Kopjar, B.

    2015-01-01

    STUDY DESIGN: Prospective, multicenter international cohort. OBJECTIVE: To evaluate outcomes of surgical decompression for cervical spondylotic myelopathy (CSM) at a global level. SUMMARY OF BACKGROUND DATA: CSM is a degenerative spine disease and the most common cause of spinal cord dysfunction wor

  16. 第23次"营养风险、不良、支持、结局与成本效益比"及"鱼油干预对结局与成本效益比的影响"工作坊纪要%The 23rd "Nutritional risk, malnutrition, nutritional support, outcome and cost/effective cohort study"and "Impact of fish oil for postoperative patients on outcome and cost/effectiveness: multi-center randomized clinical trial" workshop report

    Institute of Scientific and Technical Information of China (English)

    于康; 蒋朱明; 许静涌; 李海龙

    2010-01-01

    中华医学会肠外肠内营养学分会的"营养风险、不良、支持、结局与费用"协作组第23次工作坊于2010年8月6日至8日在北京举行.本次工作坊由来自北京、天津、重庆、成都、昆明、贵阳、广州、松原、潍坊、桂林、乌鲁木齐、青岛、岳阳和秦皇岛14个中心的共30名代表参加.工作坊的内容主要分为两大部分.第一部分:学习与本协作组研究内容有关的已发表的3篇SCI论文,以及"如何评价论文质量"和"临床医学研究设计"专题报告;第二部分:研讨本协作组目前正进行的两个研究计划,并分别领取工作任务,其中"营养风险、不良、支持、结局与成本效益比"研究计划继续目前的炎症性肠病方面的研究,"鱼油干预对结局与成本效益比"研究计划从随机对照临床试验开始进行.工作坊是高度互动和交流的平台,收效显著.第24次工作坊定于2010年12月17至19日在北京举行.%From August 6 to 8, 2010, the 23 rd "Nutritional risk, malnutrition, nutritional support, outcome, and cost-effective" workshop was held in Beijing. There were 30 participants from Beijing, Tianjin,Chongqing, Chengdu, Kunming, Guiyang, Guangzhou, Songyuan, Weifang, Guilin, Urumqi, Qingdao, Yueyang, and Qinhuangdao. The workshop has 2 sections. Section 1: Learn the published papers from ( 1 ) Jie B,Jiang ZM, Nolan MT, et al. Impact of nutritional support on clinical outcome in patients at nutritional risk: a multicenter, prospective cohort study in Baltimore and Beijing teaching hospitals. Nutrition, 2010, (9); (2)Braga M, Gianotti L. Preoperative immunonutrition: cost-benefit analysis. JPEN J Parenter Enteral Nutr,2005, 29 ( 1 Suppl): S57-S61; and ( 3 ) Jiang ZM, Wilmore DW, Wang XR, et al. Randomized clinical trial of intravenous soybean oil alone versus soybean oil plus fish oil emulsion after gastrointestinal cancer surgery. Br J Surg, 2010, 97 (6): 804-809. Section 2: Discuss two protocols for

  17. Cohort Profile

    DEFF Research Database (Denmark)

    Jespersen, Sanne; Hønge, Bo Langhoff; Oliveira, Inés;

    2014-01-01

    The West African country Guinea-Bissau is home to the world’s highest prevalence of HIV-2, and its HIV-1 prevalence is rising. Other chronic viral infections like human T-lymphotropic virus type 1 (HTLV-1) and hepatitis B virus are common as well. The Bissau HIV Cohort was started in 2007 to gain...... new insights into the overall effect of introducing antiretroviral treatment in a treatment-naı ̈ve population with concomitant infection with three retroviruses (HIV-1, HIV-2 and HTLV-1) and tuberculosis. The cohort includes patients from the HIV clinic at Hospital Nacional Sima ̃ o Mendes, the main...... hos- pital in Bissau, the capital of the country. From July 2007 to June 2013, 3762 HIV-infected patients (69% HIV-1, 18% HIV-2, 11% HIV-1/2 and 2% HIV type unknown) were included in the world’s largest single-centre HIV-2 cohort. Demographic and clinical data are col- lected at baseline and every 6...

  18. The WISTAH hand study: A prospective cohort study of distal upper extremity musculoskeletal disorders

    OpenAIRE

    Garg Arun; Hegmann Kurt T; Wertsch Jacqueline J; Kapellusch Jay; Thiese Matthew S; Bloswick Donald; Merryweather Andrew; Sesek Richard; Deckow-Schaefer Gwen; Foster James; Wood Eric; Kendall Richard; Sheng Xiaoming; Holubkov Richard

    2012-01-01

    Abstract Background Few prospective cohort studies of distal upper extremity musculoskeletal disorders have been performed. Past studies have provided somewhat conflicting evidence for occupational risk factors and have largely reported data without adjustments for many personal and psychosocial factors. Methods/design A multi-center prospective cohort study was incepted to quantify risk factors for distal upper extremity musculoskeletal disorders and potentially develop improved methods for ...

  19. Multicenter breast cancer collaborative registry.

    Science.gov (United States)

    Sherman, Simon; Shats, Oleg; Fleissner, Elizabeth; Bascom, George; Yiee, Kevin; Copur, Mehmet; Crow, Kate; Rooney, James; Mateen, Zubeena; Ketcham, Marsha A; Feng, Jianmin; Sherman, Alexander; Gleason, Michael; Kinarsky, Leo; Silva-Lopez, Edibaldo; Edney, James; Reed, Elizabeth; Berger, Ann; Cowan, Kenneth

    2011-01-01

    The Breast Cancer Collaborative Registry (BCCR) is a multicenter web-based system that efficiently collects and manages a variety of data on breast cancer (BC) patients and BC survivors. This registry is designed as a multi-tier web application that utilizes Java Servlet/JSP technology and has an Oracle 11g database as a back-end. The BCCR questionnaire has accommodated standards accepted in breast cancer research and healthcare. By harmonizing the controlled vocabulary with the NCI Thesaurus (NCIt) or Systematized Nomenclature of Medicine-Clinical Terms (SNOMED-CT), the BCCR provides a standardized approach to data collection and reporting. The BCCR has been recently certified by the National Cancer Institute's Center for Biomedical Informatics and Information Technology (NCI CBIIT) as a cancer Biomedical Informatics Grid (caBIG(®)) Bronze Compatible product.The BCCR is aimed at facilitating rapid and uniform collection of critical information and biological samples to be used in developing diagnostic, prevention, treatment, and survivorship strategies against breast cancer. Currently, seven cancer institutions are participating in the BCCR that contains data on almost 900 subjects (BC patients and survivors, as well as individuals at high risk of getting BC). PMID:21918596

  20. Study Design and Cohort Description of DEFIB-WOMEN

    DEFF Research Database (Denmark)

    Pedersen, Susanne S; Nielsen, Jens Cosedis; Riahi, Sam;

    2016-01-01

    BACKGROUND: Little systematic evidence is available on potential gender differences in patients with an implantable cardioverter defibrillator (ICD) from a real-world cohort. We designed the DEFIB-WOMEN study to examine gender differences on (i) patient reported outcomes (PROs), (ii) procedure- and...... device-related complications, and (iii) ventricular tachyarrhythmia and mortality. This presents the study design and baseline characteristics of the cohort. METHODS: DEFIB-WOMEN is a national, multi-center, prospective, observational study. First-time implanted patients are asked to complete PROs at...... several time points. Information on baseline and follow-up characteristics are captured from patients' medical records, purpose-designed questions, and the Danish national registers. The DEFIB-WOMEN cohort is comprised of 1790 (19% women; 343/1790) patients implanted between June 2010 and April 2013...

  1. The future of environmental health in Andalusian Region: suitability of improvement El futuro de la sanidad ambiental en Andalucía: oportunidades de mejora

    Directory of Open Access Journals (Sweden)

    Joaquín Jesús Gámez de la Hoz

    2008-12-01

    Full Text Available In the present article is presented a portrait of the situation of the environmental health in the administration of Andalusian Goverment; are analyzed implanted management formulations and we believe a reflection space on the professional exercise and the course begun with the organizational process in the Andalusian public health. The public health system has not undergone reconstruction from the process of transferences from the State towards the autonomous Communities. We identified the extrapolation of the model clinical-assistance management to the public health structures without delving what is sufficient in their organization and objectives. Setting of business process management (BMP has got worse the administrative bureaucracy and the teamwork has not been preceded of alliances and agreements that generate feeling of ownership the same organization to avoid professional conflicts. We bet on strengthening the paper of the environmental health technicians as referring in the identification of this performances within public health system. For this propose we need the implication of all the professionals in the reform of the organization and management of the health public, to evolve in the professional exercise creating a regulated academic specialty and to define the competences maps in their different capabilites areas.En el presente artículo se muestra un retrato de la situación de la sanidad ambiental en la Administración de la Junta de Andalucía; se analizan las fórmulas de gestión implantadas y creamos un espacio de reflexión sobre el ejercicio profesional y el rumbo iniciado con el proceso organizativo en la salud pública andaluza. La Salud Pública no ha sufrido reestructuración desde el proceso de transferencias desde el Estado hacia las comunidades autónomas. Identificamos la extrapolación del modelo de gestión clínico-asistencial a las estructuras de salud pública sin ahondar lo suficiente en su organización y

  2. Severe septic patients with mitochondrial DNA haplogroup JT show higher survival rates: a prospective, multicenter, observational study.

    Directory of Open Access Journals (Sweden)

    Leonardo Lorente

    Full Text Available OBJECTIVE: In a previous cohort study (n=96, we found an association between mitochondrial (mt DNA haplogroup JT and increased survival of severe septic patients, after controlling for age and serum lactic acid levels. The aim of this research was to increase the predictive accuracy and to control for more confounder variables in a larger cohort (n=196 of severe septic patients, to confirm whether mtDNA haplogroup JT influences short and medium-term survival in these patients. METHODS: We conducted a prospective, multicenter, observational study in six Spanish Intensive Care Units. We determined 30-day and 6-month survival and mtDNA haplogroup in this second cohort of 196 patients and in the global cohort (first and second cohorts combined with 292 severe septic patients. Multiple logistic regression and Cox regression analyses were used to test for the association of mtDNA haplogroups JT with survival at 30-days and 6-months, controlling for age, sex, serum interleukin-6 levels and SOFA score. RESULTS: Logistic and Cox regression analyses showed no differences in 30-day and 6-month survival between patients with mtDNA haplogroup JT and other haplogroups in the first cohort (n=96. In the second cohort (n=196, these analyses showed a trend to higher 30-day and 6-month survival in those with haplogroup JT. In the global cohort (n=292, logistic and Cox regression analyses showed higher 30-day and 6-month survival for haplogroup JT. There were no significant differences between J and T sub-haplogroups in 30-day and 6-month survival. CONCLUSIONS: The global cohort study (first and second cohorts combined, the largest to date reporting on mtDNA haplogroups in septic patients, confirmed that haplogroup JT patients showed increased 30-day and 6-month survival. This finding may be due to single nucleotide polymorphism defining the whole haplogroup JT and not separately for J or T sub-haplogroups.

  3. NCI Cohort Consortium Membership

    Science.gov (United States)

    The NCI Cohort Consortium membership is international and includes investigators responsible for more than 40 high-quality cohorts who are studying large and diverse populations in more than 15 different countries.

  4. Variability in modified rankin scoring across a large cohort of observers

    OpenAIRE

    Quinn, T J; Dawson, J; Walters, M; Lees, K R

    2008-01-01

    Background and Purpose— The modified Rankin scale (mRS) is the most commonly used outcome measure in stroke trials. However, substantial interobserver variability in mRS scoring has been reported. These studies likely underestimate the variability present in multicenter clinical trials, because exploratory work has only been undertaken in single centers by a few observers, all of similar training. We examined mRS variability across a large cohort of international observers using data from a v...

  5. Multi-Centered Invariants, Plethysm and Grassmannians

    OpenAIRE

    Cacciatori, S. L.; Marrani, A.; van Geemen, B.

    2013-01-01

    Motivated by multi-centered black hole solutions of Maxwell-Einstein theories of (super)gravity in D=4 space-time dimensions, we develop some general methods, that can be used to determine all homogeneous invariant polynomials on the irreducible (SL_h(p,R) x G4)-representation (p,R), where p denotes the number of centers, and SL_h(p,R) is the "horizontal" symmetry of the system, acting upon the indices labelling the centers. The black hole electric and magnetic charges sit in the symplectic r...

  6. Neurophysiology versus clinical genetics in Rett syndrome: A multicenter study.

    Science.gov (United States)

    Halbach, Nicky; Smeets, Eric E; Julu, Peter; Witt-Engerström, Ingegerd; Pini, Giorgio; Bigoni, Stefania; Hansen, Stig; Apartopoulos, Flora; Delamont, Robert; van Roozendaal, Kees; Scusa, Maria F; Borelli, Paolo; Candel, Math; Curfs, Leopold

    2016-09-01

    Many studies have attempted to establish the genotype-phenotype correlation in Rett syndrome (RTT). Cardiorespiratory measurements provide robust objective data, to correlate with each of the different clinical phenotypes. It has important implications for the management and treatment of this syndrome. The aim of this study was to correlate the genotype with the quantitative cardiorespiratory data obtained by neurophysiological measurement combined with a clinical severity score. This international multicenter study was conducted in four European countries from 1999 to 2012. The study cohort consisted of a group of 132 well-defined RTT females aged between 2 and 43 years with extended clinical, molecular, and neurophysiological assessments. Diagnosis of RTT was based on the consensus criteria for RTT and molecular confirmation. Genotype-phenotype analyses of clinical features and cardiorespiratory data were performed after grouping mutations by the same type and localization or having the same putative biological effect on the MeCP2 protein, and subsequently on eight single recurrent mutations. A less severe phenotype was seen in females with CTS, p.R133C, and p.R294X mutations. Autonomic disturbances were present in all females, and not restricted to nor influenced by one specific group or any single recurrent mutation. The objective information from non-invasive neurophysiological evaluation of the disturbed central autonomic control is of great importance in helping to organize the lifelong care for females with RTT. Further research is needed to provide insights into the pathogenesis of autonomic dysfunction, and to develop evidence-based management in RTT. © 2016 Wiley Periodicals, Inc. PMID:27354166

  7. The Global Enteric Multicenter Study (GEMS): impetus, rationale, and genesis.

    Science.gov (United States)

    Levine, Myron M; Kotloff, Karen L; Nataro, James P; Muhsen, Khitam

    2012-12-01

    Diarrheal disease remains one of the top 2 causes of young child mortality in the developing world. Whereas improvements in water/sanitation infrastructure and hygiene can diminish transmission of enteric pathogens, vaccines can also hasten the decline of diarrheal disease morbidity and mortality. From 1980 through approximately 2004, various case/control and small cohort studies were undertaken to address the etiology of pediatric diarrhea in developing countries. Many studies had methodological limitations and came to divergent conclusions, making it difficult to prioritize the relative importance of different pathogens. Consequently, in the first years of the millennium there was no consensus on what diarrheal disease vaccines should be developed or implemented; however, there was consensus on the need for a well-designed study to obtain information on the etiology and burden of more severe forms of diarrheal disease to guide global investment and implementation decisions. Accordingly, the Global Enteric Multicenter Study (GEMS) was designed to overcome drawbacks of earlier studies and determine the etiology and population-based burden of pediatric diarrheal disease. GEMS, which includes one of the largest case/control studies of an infectious disease syndrome ever undertaken (target approximately 12,600 analyzable cases and 12,600 controls), was rolled out in 4 sites in sub-Saharan Africa (Gambia, Kenya, Mali, Mozambique) and 3 in South Asia (Bangladesh, India, Pakistan), with each site linked to a population under demographic surveillance (total approximately 467,000 child years of observation among children <5 years of age). GEMS data will guide investment and help prioritize strategies to mitigate the morbidity and mortality of pediatric diarrheal disease. PMID:23169934

  8. A Multicenter Trial Defining a Serum Protein Signature Associated with Pancreatic Ductal Adenocarcinoma

    Directory of Open Access Journals (Sweden)

    Anna S. Gerdtsson

    2015-01-01

    Full Text Available Background. Pancreatic ductal adenocarcinoma (PDAC is an aggressive disease with rapid tumor progression and poor prognosis. This study was motivated by the lack of sensitive and specific PDAC biomarkers and aimed to identify a diagnostic, serum protein signature for PDAC. Methods. To mimic a real life test situation, a multicenter trial comprising a serum sample cohort, including 338 patients with either PDAC or other pancreatic diseases (OPD and controls with nonpancreatic conditions (NPC, was analyzed on 293-plex recombinant antibody microarrays targeting immunoregulatory and cancer-associated antigens. Results. Serum samples collected from different hospitals were analyzed and showed that (i sampling from five different hospitals could not be identified as a preanalytical variable and (ii a multiplexed biomarker signature could be identified, utilizing up to 10 serum markers that could discriminate PDAC from controls, with sensitivities and specificities in the 91–100% range. The first protein profiles associated with the location of the primary tumor in the pancreas could also be identified. Conclusions. The results demonstrate that robust enough serum signatures could be identified in a multicenter trial, potentially contributing to the development of a multiplexed biomarker immunoassay for improved PDAC diagnosis.

  9. Determinants of Depression in the ECLIPSE COPD Cohort

    DEFF Research Database (Denmark)

    Hanania, Nicola A; Müllerova, Hana; Locantore, Nicholas W; Vestbo, Jørgen; Watkins, Michael L; Wouters, Emiel F M; Rennard, Stephen I; Sharafkhaneh, Amir; NN, NN

    2010-01-01

    RATIONALE: Depression is prevalent in patients with chronic obstructive pulmonary disease (COPD); however, its etiology and relationship to the clinical features of COPD are not well understood. Using data from a large cohort, we explored prevalence and determinants of depression in subjects with...... COPD. METHODS: The Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study is an observational three-year multicenter study that enrolled smokers with and without COPD and non-smoker controls. At baseline, several patient-reported outcomes were measured including...... study cohort consisted of 2118 subjects with COPD, 335 smokers without COPD (smokers) and 243 non-smokers without COPD (non-smokers). Twenty-six percent, 12% and 7% of COPD, smokers and non-smokers, respectively, suffered from depression. In subjects with COPD, higher depression prevalence was seen in...

  10. Andalusian Registry for Familial Adenomatous Polyposis: Analysis of patients included Registro Andaluz de la Poliposis Adenomatosa Familiar: Análisis de los pacientes incluidos

    Directory of Open Access Journals (Sweden)

    M. Garzón Benavides

    2010-11-01

    Full Text Available Objective: To evaluate the phenotype and genotype characteristic of patients included in the Andalusian Registry for familial adenomatous polyposis, the genotype/phenotype correlation and the impact of Registry in the frequency of colorectal cancer of registered. Material and methods: A descriptive study of 77 patients with FAP belonging to 33 families, included in a centralized database visited by the physicians of the hospitals taking part in the present study, on prior signing of confidentiality letters. All genetic studies were carried out in the Immunology Service of our institution. Results: We have included in our study 77 patients of 33 families; 31 probands with a mean age of 32 years (13-51 and 46 relatives at risk with a mean age of 21.8 years (6-55. Genetic study informed in 68/77 with positive result in 92.6%. Ten probands showed colorectal cancer (CRC at the time of diagnosis (32.2%. Only two affected relatives showed CRC at diagnosis (4.3%, a statistically significant difference (p Objetivos: Valorar las características fenotípicas y genotípicas de los pacientes incluidos en el Registro Andaluz de la poliposis adenomatosa familiar, la relación genotipo/fenotipo y el impacto del Registro en la frecuencia de cáncer colorrectal de los familiares registrados. Material y métodos: Estudio descriptivo de 77 pacientes con PAF, pertenecientes a 33 familias, incluidos en una base de datos centralizada a la que tienen acceso los responsables de los hospitales participantes, previa firma de cartas de confidencialidad. Todos los estudios genéticos se realizan en el Servicio de Inmunología de nuestro Hospital. Resultados: 77 pacientes registrados (50,6% varones: 31 probandos, edad media: 32 años (13-51 y 46 familiares afectos, edad media 21,8 años (6-55. Estudio genético informado en 68/77 con resultado positivo en 92,6%. Cáncer colorrectal al diagnóstico en diez probandos (32,2% y 2 familiares afectos (4,3%, diferencia estad

  11. Cohort Profile Update

    DEFF Research Database (Denmark)

    Omland, Lars Haukali; Ahlström, Magnus Glindvad; Obel, Niels

    2014-01-01

    of Causes of Death, the Danish National Prescription Registry, the Attainment Register and the Integrated Database for Labour Market Research to get information on vital status, migration, cancer, hospital contacts, causes of death, dispensed prescriptions, education and employment. Using this design, rates...... to extract an age- and sex-matched comparison cohort from the general population, as well as cohorts of family members of the HIV-infected patients and of the comparison cohort. The combined cohort is linked with CRS, the Danish Cancer Registry, the Danish National Hospital Registry, the Danish Registry...

  12. Invasive aspergillosis: results of multicenter study

    Directory of Open Access Journals (Sweden)

    N. N. Klimko

    2014-01-01

    Full Text Available We present the results of a multicenter study of 445 patients with “proven” and “probable” invasive aspergillosis (EORTC/MSG, 2008. Invasive aspergillosis usually occurs in patients with hematological malignancies (88 %, main underlying diseases were acute myeloid and acute lymphoblastic leukemia. The risk factors: prolonged agranulocytosis (64 %, cytostatic chemotherapy (57 %, corticosteroid treatment (45 %, and allogeneic hematopoietic stem cells transplantation (29 %. The pathogens – A. fumigatus (42 %, A. niger (33 %, and A. flavus (21 %. The main site of infection were lungs (86 %. 12 week overall survival was 83 %. Bronchoscopy use for the early diagnosis (p = 0.01, adequatetherapy with voriconazole (p = 0.002 and secondary antifungal prophylaxis (p = 0.0003 were positive prognostic factors for survival of patients with invasive aspergillosis.

  13. Invasive aspergillosis: results of multicenter study

    Directory of Open Access Journals (Sweden)

    N. N. Klimko

    2014-09-01

    Full Text Available We present the results of a multicenter study of 445 patients with “proven” and “probable” invasive aspergillosis (EORTC/MSG, 2008. Invasive aspergillosis usually occurs in patients with hematological malignancies (88 %, main underlying diseases were acute myeloid and acute lymphoblastic leukemia. The risk factors: prolonged agranulocytosis (64 %, cytostatic chemotherapy (57 %, corticosteroid treatment (45 %, and allogeneic hematopoietic stem cells transplantation (29 %. The pathogens – A. fumigatus (42 %, A. niger (33 %, and A. flavus (21 %. The main site of infection were lungs (86 %. 12 week overall survival was 83 %. Bronchoscopy use for the early diagnosis (p = 0.01, adequatetherapy with voriconazole (p = 0.002 and secondary antifungal prophylaxis (p = 0.0003 were positive prognostic factors for survival of patients with invasive aspergillosis.

  14. Reliability of Semiautomated Computational Methods for Estimating Tibiofemoral Contact Stress in the Multicenter Osteoarthritis Study

    Directory of Open Access Journals (Sweden)

    Donald D. Anderson

    2012-01-01

    Full Text Available Recent findings suggest that contact stress is a potent predictor of subsequent symptomatic osteoarthritis development in the knee. However, much larger numbers of knees (likely on the order of hundreds, if not thousands need to be reliably analyzed to achieve the statistical power necessary to clarify this relationship. This study assessed the reliability of new semiautomated computational methods for estimating contact stress in knees from large population-based cohorts. Ten knees of subjects from the Multicenter Osteoarthritis Study were included. Bone surfaces were manually segmented from sequential 1.0 Tesla magnetic resonance imaging slices by three individuals on two nonconsecutive days. Four individuals then registered the resulting bone surfaces to corresponding bone edges on weight-bearing radiographs, using a semi-automated algorithm. Discrete element analysis methods were used to estimate contact stress distributions for each knee. Segmentation and registration reliabilities (day-to-day and interrater for peak and mean medial and lateral tibiofemoral contact stress were assessed with Shrout-Fleiss intraclass correlation coefficients (ICCs. The segmentation and registration steps of the modeling approach were found to have excellent day-to-day (ICC 0.93–0.99 and good inter-rater reliability (0.84–0.97. This approach for estimating compartment-specific tibiofemoral contact stress appears to be sufficiently reliable for use in large population-based cohorts.

  15. Quality Control Measures over 30 Years in a Multicenter Clinical Study: Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study

    OpenAIRE

    Lorenzi, Gayle M.; Braffett, Barbara H.; Arends, Valerie L.; Danis, Ronald P.; Diminick, Lisa; Klumpp, Kandace A.; Morrison, Anthony D.; Soliman, Elsayed Z.; Steffes, Michael W.; Cleary, Patricia A.; ,

    2015-01-01

    Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time. The Diabetes Control and Complications Trial (DCCT) and the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC) study represent over 30 years of data collection among a cohort of participants across 27 clinical centers. The quality assurance plan is overseen by the Data Coordinatin...

  16. Risk factors for self-reported arm lymphedema among female breast cancer survivors: a prospective cohort study

    OpenAIRE

    Togawa, Kayo; Ma, Huiyan; Sullivan-Halley, Jane; Neuhouser, Marian L.; Imayama, Ikuyo; Baumgartner, Kathy B.; Smith, Ashley Wilder; Alfano, Catherine M.; McTiernan, Anne; Ballard-Barbash, Rachel; Bernstein, Leslie

    2014-01-01

    Introduction Lymphedema is a potentially debilitating condition that occurs among breast cancer survivors. This study examines the incidence of self-reported lymphedema, timing of lymphedema onset, and associations between sociodemographic, clinical and lifestyle factors and lymphedema risk across racial-ethnic groups using data from a multicenter, multiethnic prospective cohort study of breast cancer survivors, the Health, Eating, Activity and Lifestyle Study. Methods A total of 666 women di...

  17. Marijuana Smoking Does Not Accelerate Progression of Liver Disease in HIV–Hepatitis C Coinfection: A Longitudinal Cohort Analysis

    OpenAIRE

    Brunet, Laurence; Moodie, Erica E M; Rollet, Kathleen; Cooper, Curtis; Walmsley, Sharon; Potter, Martin; Klein, Marina B; ,

    2013-01-01

    Background.  Marijuana smoking is common and believed to relieve many symptoms, but daily use has been associated with liver fibrosis in cross-sectional studies. We aimed to estimate the effect of marijuana smoking on liver disease progression in a Canadian prospective multicenter cohort of human immunodeficiency virus/hepatitis C virus (HIV/HCV) coinfected persons. Methods.  Data were analyzed for 690 HCV polymerase chain reaction positive (PCR-positive) individuals without significant fibro...

  18. A hinged external fixator for complex elbow dislocations: A multicenter prospective cohort study

    OpenAIRE

    Verleisdonk Egbert JMM; Van Vugt Arie B; Van Thiel Tom PH; Van der Meulen Hub GWM; Sintenie Jan; Schipper Inger B; Roukema Gert R; Rhemrev Steven; Ham S John; Goslings J Carel; De Vries Mark R; Bronkhorst Maarten WGA; Tuinebreijer Wim E; Iordens Gijs IT; de Haan Jeroen

    2011-01-01

    Abstract Background Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures of the radial head, olecranon, or coronoid process. The majority of patients with these complex dislocations are treated with open reduction and internal fixation (ORIF), or arthroplasty in case of a non-reconstructable radial head fracture. If the elbow joint remains unstable after fracture f...

  19. Community- and healthcare-associated infections in critically ill patients: a multicenter cohort study

    Directory of Open Access Journals (Sweden)

    George Dabar

    2015-08-01

    Conclusions: Severe sepsis and septic shock had a high mortality rate, especially in the HAI group. Patients with risk factors for increased mortality should be monitored and aggressive treatment should be administered.

  20. A hinged external fixator for complex elbow dislocations: A multicenter prospective cohort study

    NARCIS (Netherlands)

    N.W.L. Schep (Niels); J. de Haan (Jeroen); G.I.T. Iordens (Gijs); W.E. Tuinebreijer (Wim); M.W.G.A. Bronkhorst (Maarten); M.R. de Vries (Mark); J.C. Goslings (Carel); S.J. Ham (John); S. Rhemrev (Steven); G.R. Roukema (Gert); I.B. Schipper (Inger); J.B. Sintenie (Jan Bernard); H.G.W.M. Meulen (Hub); T.P.H. Thiel (Tom); A.B. van Vugt (Arie); E.J.M.M. Verleisdonk (Egbert); J.P.A.M. Vroemen (Jos); P. Wittich (Philippe); P. Patka (Peter); E.M.M. van Lieshout (Esther); D. den Hartog (Dennis)

    2011-01-01

    textabstractBackground: Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures of the radial head, olecranon, or coronoid process. The majority of patients with these compl

  1. A hinged external fixator for complex elbow dislocations: a multicenter prospective cohort study

    NARCIS (Netherlands)

    N.W.L. Schep; J. den Haan; G.I.T. Iordens; W.E. Tuinebreijer; M.W.G.A. Bronkhorst; M.R. de Vries; J.C. Goslings; S.J. Ham; S. Rhemrev; G.R. Roukema; I.B. Schipper; J.B. Sintenie; H.G.W.M. van der Meulen; T.P.H. van Thiel; A.B. van Vugt; E.J.M.M. Verleisdonk; J.P.A.M. Vroemen; P. Wittich; P. Patka; E.M.M. van Lieshout; D. den Hartog

    2011-01-01

    Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures of the radial head, olecranon, or coronoid process. The majority of patients with these complex dislocations are trea

  2. Computed tomography in children: multicenter cohort study design for the evaluation of cancer risk

    International Nuclear Information System (INIS)

    Exposure to ionizing radiation is a known risk factor for cancer. Cancer risk is highest after exposure in childhood. The computed tomography is the major contributor to the average, individual radiation exposure. Until now the association has been addressed only in statistical modeling. We present the first feasible study design on childhood cancer risk after exposure to computed tomography.

  3. Cohort Profile: Mysore Parthenon Birth Cohort

    OpenAIRE

    Krishnaveni, Ghattu V.; Veena, Sargoor R; Hill, Jacqueline C.; Karat, Samuel C.; Fall, Caroline HD

    2014-01-01

    The Mysore Parthenon Birth Cohort was established to examine the long-term effects of maternal glucose tolerance and nutritional status on cardiovascular disease risk factors in the offspring. During 1997-1998, 830 of 1233 women recruited from the antenatal clinics of the Holdsworth Memorial Hospital (HMH), Mysore, India underwent an oral glucose tolerance test. Of these, 667 women delivered live babies at HMH. Four babies with major congenital anomalies were excluded, and the remaining 663 w...

  4. Cancer Epidemiology Cohorts

    Science.gov (United States)

    Cohort studies are fundamental for epidemiological research by helping researchers better understand the etiology of cancer and provide insights into the key determinants of this disease and its outcomes.

  5. Multi-Centered Invariants, Plethysm and Grassmannians

    CERN Document Server

    Cacciatori, Sergio L; van Geemen, Bert

    2013-01-01

    Motivated by multi-centered black hole solutions of Maxwell-Einstein theories of (super)gravity in D=4 space-time dimensions, we develop some general methods, that can be used to determine all homogeneous invariant polynomials on the irreducible (SL_h(p,R) x G4)-representation (p,R), where p denotes the number of centers, and SL_h(p,R) is the "horizontal" symmetry of the system, acting upon the indices labelling the centers. The black hole electric and magnetic charges sit in the symplectic representation R of the generalized electric-magnetic (U-)duality group G4. We start with an algebraic approach based on classical invariant theory, using Schur polynomials and the Cauchy formula. Then, we perform a geometric analysis, involving Grassmannians, Pluecker coordinates, and exploiting Bott's Theorem. We focus on non-degenerate groups G4 "of type E7" relevant for (super)gravities whose (vector multiplets') scalar manifold is a symmetric space. In the triality-symmetric stu model of N=2 supergravity, we explicitl...

  6. Occupational Cohort Time Scales

    OpenAIRE

    Deubner, David C.; Roth, H. Daniel

    2015-01-01

    Purpose: This study explores how highly correlated time variables (occupational cohort time scales) contribute to confounding and ambiguity of interpretation. Methods: Occupational cohort time scales were identified and organized through simple equations of three time scales (relational triads) and the connections between these triads (time scale web). The behavior of the time scales was examined when constraints were imposed on variable ranges and interrelationships. Results: Constraints on ...

  7. 1970 British Cohort Study

    Directory of Open Access Journals (Sweden)

    Matt Brown

    2014-10-01

    Full Text Available The 1970 British Cohort Study (BCS70 is one of Britain’s world famous national longitudinal birth cohort studies, three of which are run by the Centre for Longitudinal Studies at the Institute of Education, University of London. BCS70 follows the lives of more than 17,000 people born in England, Scotland and Wales in a single week of 1970. Over the course of cohort members lives, the BCS70 has collected information on health, physical, educational and social development, and economic circumstances among other factors. Since the birth survey in 1970, there have been nine ‘sweeps’ of all cohort members at ages 5, 10, 16, 26, 30, 34, 38 and most recently at 42. Data has been collected from a number of different sources (the midwife present at birth, parents of the cohort members, head and class teachers, school health service personnel and the cohort members themselves. The data has been collected in a variety of ways including via paper and electronic questionnaires, clinical records, medical examinations, physical measurements, tests of ability, educational assessments and diaries. The majority of can be accessed by bona fide researchers through the a href="http://discover.ukdataservice.ac.uk/series/?sn=200001" UK Data Service at the University of Essex.

  8. 1970 British Cohort Study

    Directory of Open Access Journals (Sweden)

    Matt Brown

    2014-10-01

    Full Text Available The 1970 British Cohort Study (BCS70 is one of Britain’s world famous national longitudinal birth cohort studies, three of which are run by the Centre for Longitudinal Studies at the Institute of Education, University of London.  BCS70 follows the lives of more than 17,000 people born in England, Scotland and Wales in a single week of 1970. Over the course of cohort members lives, the BCS70 has collected information on health, physical, educational and social development, and economic circumstances among other factors. Since the birth survey in 1970, there have been nine ‘sweeps’ of all cohort members at ages 5, 10, 16, 26, 30, 34, 38 and most recently at 42. Data has been collected from a number of different sources (the midwife present at birth, parents of the cohort members, head and class teachers, school health service personnel and the cohort members themselves. The data has been collected in a variety of ways including via paper and electronic questionnaires, clinical records, medical examinations, physical measurements, tests of ability, educational assessments and diaries. The majority of BCS70 survey data can be accessed by bona fide researchers through the UK Data Service at the University of Essex.

  9. Opiniones y experiencias en el desempeño de la dirección escolar de las mujeres directoras en Andalucía. [Andalusian women principals’ opinions and experiences about their school management performance

    Directory of Open Access Journals (Sweden)

    Padilla Carmona, M. Teresa

    2008-06-01

    Full Text Available This paper aims to identify the opinions and experiences in school management held by women principals in Andalusian early and elementary public schools. Using the survey method, data were collected through a questionnaire from a sample of 206 principals selected through a several-stages procedure. Results show that most women principals were middle-aged, have an extensive professional experience and have no children or other people under their care. They occupied the headship due to altruistic and personal reasons, and they considered the lack of support from Educational Administration as the main problem they have to cope. Also, they conceived their work as a team effort with a facilitator function. Este trabajo persigue identificar las opiniones y experiencias ante la dirección escolar de las directoras de centros públicos de Educación Infantil y Primaria en Andalucía. Se realizó un estudio tipo encuesta con una muestra de 206 directoras seleccionada mediante un muestreo polietápico, utilizando el cuestionario para la recogida de información. Los resultados muestran que las directoras tienen mediana edad, una dilatada experiencia profesional y, en su mayoría, están relativamente libres de cargas familiares. Accedieron al cargo por razones altruistas y personales, y señalan la falta de apoyo de la Administración como su principal problema. Conciben su función como una labor de equipo eminentemente facilitadora.

  10. The Danish Youth Cohort

    DEFF Research Database (Denmark)

    Vinther-Larsen, Mathilde; Riegels, Mette; Rod, Morten Hulvej;

    2010-01-01

    income. Loss to follow-up was only associated with adolescents' higher probability of drinking and use of tobacco, and none of the other factors were associated with attrition. CONCLUSIONS: The participants in the Danish Youth Cohort represent a great variety of different groups of socio......AIMS: The aim of this paper is to describe the design and methods used in the Danish Youth Cohort and to give a description of the study participants with special attention to a comparison between participants and non-participants regarding sociodemographic characteristics. METHODS: A total of 1......,945 schools were invited, out of which 506 participated. The participating 7th grades comprised a total of 12,498 responding adolescents. The response rate for the Danish Youth Cohort established in 2005 was 63%. The sample of 12,498 adolescents represents 18.2% of all pupils (n = 68,764) in the 7th grade...

  11. The MANGUA Project: A Population-Based HIV Cohort in Guatemala

    Science.gov (United States)

    García, Juan Ignacio; Samayoa, Blanca; Sabidó, Meritxell; Prieto, Luis Alberto; Nikiforov, Mikhail; Pinzón, Rodolfo; Santa Marina de León, Luis Roberto; Ortiz, José Fernando; Ponce, Ernesto; Mejía, Carlos Rodolfo; Arathoon, Eduardo; Casabona, Jordi; Study Group, The Mangua Cohort

    2015-01-01

    Introduction. The MANGUA cohort is an ongoing multicenter, observational study of people living with HIV/AIDS in Guatemala. The cohort is based on the MANGUA application which is an electronic database to capture essential data from the medical records of HIV patients in care. Methods. The cohort enrolls HIV-positive adults ≥16 years of age. A predefined set of sociodemographic, behavioral, clinical, and laboratory data are registered at entry to the cohort study. Results. As of October 1st, 2012, 21 697 patients had been included in the MANGUA cohort (median age: 33 years, 40.3% female). At enrollment 74.1% had signs of advanced HIV infection and only 56.3% had baseline CD4 cell counts. In the first 12 months after starting antiretroviral treatment 26.9% (n = 3938) of the patients were lost to the program. Conclusions. The implementation of a cohort of HIV-positive patients in care in Guatemala is feasible and has provided national HIV indicators to monitor and evaluate the HIV epidemic. The identified percentages of late presenters and high rates of LTFU will help the Ministry to target their current efforts in improving access to diagnosis and care. PMID:26425365

  12. Czech multicenter research database of severe COPD

    Directory of Open Access Journals (Sweden)

    Novotna B

    2014-11-01

    Full Text Available Barbora Novotna,1 Vladimir Koblizek,1 Jaromir Zatloukal,2 Marek Plutinsky,3 Karel Hejduk,4 Zuzana Zbozinkova,4 Jiri Jarkovsky,4 Ondrej Sobotik,5 Tomas Dvorak,6 Petr Safranek71Department of Pneumology, University Hospital Hradec Kralove, Charles University in Prague, Faculty of Medicine in Hradec Kralove, Hradec Kralove, 2Department of Pulmonology, University Hospital, Palacky University, Olomouc, 3Department of Pulmonology, University Hospital, Masaryk University, Brno, 4Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, 5Department of Pulmonology, University Hospital Motol, Charles University, Praha, 6Department of Pulmonology, Hospital Bulovka, Praha, 7Department of Pulmonology, University Hospital, Charles University, Plzen, the Czech RepublicPurpose: Chronic obstructive pulmonary disease (COPD has been recognized as a heterogeneous, multiple organ system-affecting disorder. The Global Initiative for Chronic Obstructive Lung Disease (GOLD places emphasis on symptom and exacerbation management. The aim of this study is examine the course of COPD and its impact on morbidity and all-cause mortality of patients, with respect to individual phenotypes and GOLD categories. This study will also evaluate COPD real-life patient care in the Czech Republic.Patients and methods: The Czech Multicentre Research Database of COPD is projected to last for 5 years, with the aim of enrolling 1,000 patients. This is a multicenter, observational, and prospective study of patients with severe COPD (post-bronchodilator forced expiratory volume in 1 second ≤60%. Every consecutive patient, who fulfils the inclusion criteria, is asked to participate in the study. Patient recruitment is done on the basis of signed informed consent. The study was approved by the Multicentre Ethical Committee in Brno, Czech Republic.Results: The objective of this paper was to outline the methodology of this study.Conclusion: The establishment of the

  13. Infliximab-induced autoantibodies: a multicenter study.

    Science.gov (United States)

    Vaz, João Luiz Pereira; Fernandes, Vander; Nogueira, Felipe; Arnóbio, Adriano; Levy, Roger A

    2016-02-01

    The purpose of this study was to assess autoantibody incidence in patients treated with infliximab for various diseases, and the development of autoimmune diseases using a multicenter, longitudinal, open-label, phase IV observational study. All patients received anti-tumor necrosis factor (anti-TNF) according to local treatment guidelines. The autoantibodies assessed before and after infliximab treatment were ANA, anti-Sm, anti-dsDNA, anticardiolipin IgM/IgG, anti-Scl70, anti-centromere B, anti-chromatin, anti-ribosomal P, anti-Sm-RNP, anti-RNP A, anti-RNP 68 kD, anti-La/SSB, anti-Ro/SSA 52 kD and 60 kD, and anti-Jo1. ANA was determined by indirect immunofluorescence on HEp-2 cells (INOVA); the remaining was assessed using BioPlexTM 2200. The Fisher exact test, Wilcoxon test, and the McNemar were used when appropriate.Two hundred eighty-six patients were included (139 with rheumatoid arthritis, 77 with ankylosing spondylitis, 29 with inflammatory bowel disease, 27 with psoriatic arthritis, and 14 with psoriasis), 167 females and 119 males, with mean age of 46.3 years. Subjects received at least five infusions of infliximab (6-month treatment). A significant difference was observed in antinuclear antibody (ANA) detection between samplings (p = 0.001). Among patients that had ANA before treatment (n = 92), six became ANA-negative, 48 had increased titers, 29 maintained, and nine decreased titers after treatment; a total of 186 patients had a positive ANA after treatment. Fine speckled nuclear pattern was most commonly observed (both before and after infliximab treatment). The number of patients with anti-dsDNA had a statistically significant increase (p = 0.003). No significant differences were noted for anticardiolipin and the remaining autoantibodies tested. Among the 286 patients included in the study, only one (0.35 %) showed clinical signs of drug-induced lupus, presenting elevated ANA and anti-dsDNA titers that normalized once treatment was

  14. Chronic nonbacterial osteomyelitis in children: a retrospective multicenter study

    OpenAIRE

    Kaiser, Daniela; Bolt, Isabel; Hofer, Michael; Relly, Christa; Berthet, Gerald; Bolz, Dieter; Saurenmann, Traudel

    2015-01-01

    Background To determine the clinical presentation, current treatment and outcome of children with nonbacterial inflammatory bone disease. Methods Retrospective multicenter study of patients entered into the Swiss Pediatric Rheumatology Working Group registry with a diagnosis of chronic nonbacterial osteomyelitis (CNO) and synovitis acne pustulosis hyperostosis osteitis (SAPHO) syndrome. The charts were reviewed for informations about disease presentation, treatment, course and outcome. Result...

  15. Chronic nonbacterial osteomyelitis in children: a retrospective multicenter study

    OpenAIRE

    Kaiser, Daniela; Bolt, Isabel; Hofer, Michael; Relly, Christa; Berthet, Gerald; Bolz, Dieter; Saurenmann, Traudel

    2015-01-01

    BACKGROUND: To determine the clinical presentation, current treatment and outcome of children with nonbacterial inflammatory bone disease. METHODS: Retrospective multicenter study of patients entered into the Swiss Pediatric Rheumatology Working Group registry with a diagnosis of chronic nonbacterial osteomyelitis (CNO) and synovitis acne pustulosis hyperostosis osteitis (SAPHO) syndrome. The charts were reviewed for informations about disease presentation, treatment, course and outcome. ...

  16. NCI Cohort Consortium

    Science.gov (United States)

    The NCI Cohort Consortium is an extramural-intramural partnership formed by the National Cancer Institute to address the need for large-scale collaborations to pool the large quantity of data and biospecimens necessary to conduct a wide range of cancer studies.

  17. International Childhood Cancer Cohort Consortium

    Science.gov (United States)

    An alliance of several large-scale prospective cohort studies of children to pool data and biospecimens from individual cohorts to study various modifiable and genetic factors in relation to cancer risk

  18. Cohort postponement and period measures

    OpenAIRE

    Joshua R. Goldstein; Thomas Cassidy

    2010-01-01

    We introduce a new class of models in which demographic behavior such as fertility is postponed by differing amounts depending only on cohort membership. We show how this model fits into a general framework of period and cohort postponement that includes the existing models in the literature, notably those of Bongaarts and Feeney and Kohler and Philipov. The cohort-based model shows the effects of cohort shifts on period fertility measures and provides an accompanying tempo-adjusted measure o...

  19. Design, implementation, and quality control in the Pathways American-Indian multicenter trial

    Science.gov (United States)

    Stone, Elaine J.; Norman, James E.; Davis, Sally M.; Stewart, Dawn; Clay, Theresa E.; Caballero, Ben; Lohman, Timothy G.; Murray, David M.

    2016-01-01

    Background Pathways was the first multicenter American-Indian school-based study to test the effectiveness of an obesity prevention program promoting healthy eating and physical activity. Methods Pathways employed a nested cohort design in which 41 schools were randomized to intervention or control conditions and students within these schools were followed as a cohort (1,704 third graders at baseline). The study’s primary endpoint was percent body fat. Secondary endpoints were levels of fat in school lunches; time spent in physical activity; and knowledge, attitudes, and behaviors regarding diet and exercise. Quality control (QC) included design of data management systems which provided standardization and quality assurance of data collection and processing. Data QC procedures at study centers included manuals of operation, training and certification, and monitoring of performance. Process evaluation was conducted to monitor dose and fidelity of the interventions. Registration and tracking systems were used for students and schools. Results No difference in mean percent body fat at fifth grade was found between the intervention and control schools. Percent of calories from fat and saturated fat in school lunches was significantly reduced in the intervention schools as was total energy intake from 24-hour recalls. Significant increases in self-reported physical activity levels and knowledge of healthy behaviors were found for the intervention school students. Conclusions The Pathways study results provide evidence demonstrating the role schools can play in public health promotion. Its study design and QC systems and procedures provide useful models for other similar school based multi- or single-site studies. PMID:14636805

  20. Assessment of asthma control and asthma exacerbations in the epidemiology and natural history of asthma: outcomes and treatment regimens (TENOR) observational cohort

    OpenAIRE

    Chipps, Bradley E.; Zeiger, Robert S.; Dorenbaum, Alejandro; Borish, Larry; Wenzel, Sally E.; Miller, Dave P.; Hayden, Mary Lou; Bleecker, Eugene R.; Simons, F. Estelle R.; Szefler, Stanley J.; Weiss, Scott Tillman; Haselkorn, Tmirah

    2012-01-01

    Patients with severe or difficult-to-treat asthma account for substantial asthma morbidity, mortality, and healthcare burden despite comprising only a small proportion of the total asthma population. TENOR, a multicenter, observational, prospective cohort study was initiated in 2001. It enrolled 4,756 adults, adolescents and children with severe or difficult-to-treat asthma who were followed semi-annually and annually for three years, enabling insight to be gained into this understudied popul...

  1. Early and Late Retrieval of the ALN Removable Vena Cava Filter: Results from a Multicenter Study

    International Nuclear Information System (INIS)

    Retrieval of removable inferior vena cava (IVC) filters in selected patients is widely practiced. The purpose of this multicenter study was to evaluate the feasibility and results of percutaneous removal of the ALN removable filter in a large patient cohort. Between November 2003 and June 2006, 123 consecutive patients were referred for percutaneous extraction of the ALN filter at three centers. The ALN filter is a removable filter that can be implanted through a femoral/jugular vein approach and extracted by the jugular vein approach. Filter removal was attempted after an implantation period of 93 ± 15 days (range, 6-722 days) through the right internal jugular vein approach using the dedicated extraction kit after control inferior vena cavography. Following filter removal, vena cavograms were obtained in all patients. Successful extraction was achieved in all but one case. Among these successful retrievals, additional manipulation using a femoral approach was needed when the apex of the filter was close to the IVC wall in two patients. No immediate IVC complications were observed according to the postimplantation cavography. Neither technical nor clinical differences between early and late filter retrieval were noticed. Our data confirm the safety of ALN filter retrieval up to 722 days after implantation. In infrequent cases, additional endovenous filter manipulation is needed to facilitate extraction.

  2. Confirmed adult dengue deaths in Singapore: 5-year multi-center retrospective study

    Directory of Open Access Journals (Sweden)

    Narayanan Rajmohan L

    2011-05-01

    Full Text Available Abstract Background Dengue re-emerges in Singapore despite decades of effective vector control; the infection predominantly afflicts adults. Severe dengue not fulfilling dengue hemorrhagic fever (DHF criteria according to World Health Organization (WHO 1997 guideline was increasingly reported. A new WHO 2009 guideline emphasized warning signs and a wider range of severe dengue manifestations. We aim to evaluate the utility of these two guidelines in confirmed adult dengue fatalities. Methods We conducted a multi-center retrospective chart review of all confirmed adult dengue deaths in Singapore from 1 January 2004 to 31 December 2008. Results Of 28 adult dengue deaths, median age was 59 years. Male gender comprised 67.9% and co-morbidities existed in 75%. From illness onset, patients presented for admission at a median of 4 days and death occurred at a median of 12 days. Intensive care admission was required in 71.4%. Probable dengue was diagnosed in 32.1% by WHO 1997 criteria and 78.6% by WHO 2009. The earliest warning sign was persistent vomiting at a median of 1.5 days. Hematocrit change ≥20% concurrent with platelet count Conclusions In our adult fatal dengue cohort, WHO 2009 criteria had higher sensitivity in diagnosing probable dengue and severe dengue compared with WHO 1997. As warning signs, persistent vomiting occurred early and hematocrit change ≥20% concurrent with platelet count

  3. Cohort profile: Mysore parthenon birth cohort.

    Science.gov (United States)

    Krishnaveni, Ghattu V; Veena, Sargoor R; Hill, Jacqueline C; Karat, Samuel C; Fall, Caroline H D

    2015-02-01

    The Mysore Parthenon Birth Cohort was established to examine the long-term effects of maternal glucose tolerance and nutritional status on cardiovascular disease risk factors in the offspring. During 1997-98, 830 of 1233 women recruited from the antenatal clinics of the Holdsworth Memorial Hospital (HMH), Mysore, India, underwent an oral glucose tolerance test. Of these, 667 women delivered live babies at HMH. Four babies with major congenital anomalies were excluded, and the remaining 663 were included for further follow-up. The babies had detailed anthropometry at birth and at 6-12-monthly intervals subsequently. Detailed cardiovascular investigations were done at ages 5, 9.5 and 13.5 years in the children, and in the parents at the 5-year and 9.5-year follow-ups. This ongoing study provides extensive data on serial anthropometry and body composition, physiological and biochemical measures, dietary intake, nutritional status, physical activity measures, stress reactivity measures and cognitive function, and socio-demographic parameters for the offspring. Data on anthropometry, cardiovascular risk factors and nutritional status are available for mothers during pregnancy. Anthropometry and risk factor measures are available for both parents at follow-up. PMID:24609067

  4. El Uso de las Redes Sociales en las Universidades Andaluzas: El Caso de Facebook y Twitter/ The Use of Social Media in the Andalusian Universities: The Case of Facebook and Twitter

    Directory of Open Access Journals (Sweden)

    Jesús Reina Estevez

    2012-12-01

    Full Text Available ResumenLa Universidad es una institución al servicio de la sociedad. Con su actividad y conocimientos se avanza en el desarrollo social, económico y cultural. La Web 2.0 permite que la organización interactúe con sus públicos y con los usuarios, comunicándose a un nivel nuevo, sin limitaciones temporales o espaciales. La siguiente investigación se lleva a cabo sobre las Universidades Públicas Andaluzas, para estudiar su presencia en las redes sociales, y el uso que están haciendo de las mismas; concretamente, sobre Facebook y Twitter, por ser las redes sociales más destacadas y populares. La metodología utilizada es de carácter empírico-analítico, y se apoya en el uso de la técnica del análisis de contenido.AbstractUniversity is an institution at the service of society. With its knowledge and activity it is advanced in social, economic and cultural development. Web 2.0 allows to the institution to interact with their audiences and users, communicating to a new level, with no temporal or spatial limitations. The following research was conducted on Andalusian Public Universities to study their social media presence, and how are making use of them, specifically, on Facebook and Twitter, being the most prominent and popular social media. The methodology used is empirical-analytic, and relies on the use of the technique of content analysis.

  5. A pragmatic discussion on establishing a multicenter digital imaging network.

    Science.gov (United States)

    Ingeholm, Mary Lou; Levine, Betty A; Fatemi, Seyed Ali; Moser, And Hugo W

    2002-01-01

    Multicenter clinical trials for therapy evaluation of rare diseases are necessary. A digital imaging network improves the ability to share information between collaborating institutions for adrenoleukodystrophy. The DICOM 3.0 standard is used to move images over the Internet from contributing sites to the central clinical database and on to the reviewing physicians' workstations. Patient confidentiality and data integrity are ensured during transmission using virtual private network technology. Fifteen sites are participating in the network. Of these sites, 6 use the proposed protocol. The other 9 sites have either security policy issues or technical considerations that dictate alternative protocols. Network infrastructure, Internet access, image management practices, and security policies vary significantly between sites. Successful implementation of a multicenter digital imaging network requires flexibility in the implementation of network connectivity. Flexibility increases participation as well as complexity of the network. PMID:12105723

  6. Multicenter Study of Voriconazole Pharmacokinetics and Therapeutic Drug Monitoring

    OpenAIRE

    Dolton, Michael J.; Ray, John E; Chen, Sharon C.-A.; Ng, Kingsley; Pont, Lisa G.; McLachlan, Andrew J.

    2012-01-01

    Voriconazole is a first-line agent in the treatment of many invasive fungal infections and is known to display highly variable pharmacokinetics. Previous studies of voriconazole therapeutic drug monitoring (TDM) have suggested concentration monitoring to be clinically useful but have been limited by small patient samples at a single institution. This multicenter retrospective study aimed to investigate relationships between voriconazole concentration and clinical outcomes and adverse events a...

  7. Management of Pneumothorax in Emergency Medicine Departments: Multicenter Trial

    OpenAIRE

    Ince, Abdulkadir; Ozucelik, Dogac Niyazi; Avci, Akkan; Nizam, Ozgur; Dogan, Halil; Topal, Mehmet Ali

    2013-01-01

    Background: Pneumothorax is common and life-threatening clinical condition which may require emergency treatment in Emergency Medicine Departments. Objectives: We aimed to reveal the epidemiological analysis of the patients admitted to the Emergency Department with pneumothorax. Material and Methods: This case-control and multi-center study was conducted in the patients treated with the diagnosis of pneumothorax between 01.01.2010-31.12.2010. Patient data were collected from hospital automati...

  8. Surgical site infections in Italian Hospitals: a prospective multicenter study

    OpenAIRE

    Ippolito Giuseppe; Martini Lorena; Nicastri Emanuele; Drapeau Cecilia MJ; Petrosillo Nicola; Moro Maria

    2008-01-01

    Abstract Background Surgical site infections (SSI) remain a major clinical problem in terms of morbidity, mortality, and hospital costs. Nearly 60% of SSI diagnosis occur in the postdischarge period. However, literature provides little information on risk factors associated to in-hospital and postdischarge SSI occurrence. A national prospective multicenter study was conducted with the aim of assessing the incidence of both in-hospital and postdisharge SSI, and the associated risk factors. Met...

  9. Chronic gastritis in China: a national multi-center survey

    OpenAIRE

    Du, Yiqi; Bai, Yu; Xie, Pei; Fang, Jingyuan; Wang, Xiaozhong; Hou, Xiaohua; TIAN, DEAN; Wang, Chengdang; Liu, Yandi; Sha, Weihong; Wang, Bangmao; Li, Yanqing; Zhang, Guoliang; Li, Yan; Shi, Ruihua

    2014-01-01

    Background Chronic gastritis is one of the most common findings at upper endoscopy in the general population, and chronic atrophic gastritis is epidemiologically associated with the occurrence of gastric cancer. However, the current status of diagnosis and treatment of chronic gastritis in China is unclear. Methods A multi-center national study was performed; all patients who underwent diagnostic upper endoscopy for evaluation of gastrointestinal symptoms from 33 centers were enrolled. Data i...

  10. Vitamin D and tuberculosis: a multicenter study in children

    OpenAIRE

    Venturini, Elisabetta; Facchini, Ludovica; Martinez-Alier, Nuria; Novelli, Vas; Galli, Luisa; Martino, Maurizio; Chiappini, Elena

    2014-01-01

    Background The aim of this study is to evaluate vitamin D levels in children with latent and active TB compared to healthy controls of the same age and ethnical background. Methods A multicenter observational study has been conducted in three tertiary care paediatric centres: Anna Meyer Children's University Hospital, Florence, Italy; Evelina London Children's Hospital, London, United Kingdom and Great Ormond Street Hospital, London, United Kingdom. Vitamin D was considered deficient if the s...

  11. Constitutional multicenter bank linked to Sasang constitutional phenotypic data

    OpenAIRE

    Jin, Hee-Jeong; Baek, Younghwa; Kim, Ho-Seok; Ryu, Jonghyang; Lee, Siwoo

    2015-01-01

    Background Biobanks are more important in medical area because they can give researchers data for demonstrating and validating their research. In this study, we developed a biobank called the Korea Constitutional Multicenter Bank (KCMB) based on Sasang Constitutional Medicine (SCM). The aim of the KCMB was a foundation to providing the scientific basis of SCM. Methods The KCMB has been constructed since 2006 in 24 Korean medical clinics with collection of questionnaire data, physical measurem...

  12. Stratified case-cohort analysis of general cohort sampling designs

    OpenAIRE

    2006-01-01

    We first point out that variance estimates for regression coefficients in exposure stratified case-cohort studies (Borgan et al., 2000) can easily be obtained from influence terms routinely calculated in standard software for Cox regression. We also place the estimators proposed by Chen (2001) for a general class of cohort sampling designs within the Borgan et al. framework by allowing for post-stratification on outcome. This facilitates simple variance estimation for this class of cohort sam...

  13. Prognosis and predictors of ACL reconstructions using the MOON cohort: a model for comparative effectiveness studies.

    Science.gov (United States)

    Spindler, Kurt P; Parker, Richard D; Andrish, Jack T; Kaeding, Christopher C; Wright, Rick W; Marx, Robert G; McCarty, Eric C; Amendola, Annunziato; Dunn, Warren R; Huston, Laura J; Harrell, Frank E

    2013-01-01

    Injury to the anterior cruciate ligament (ACL) threatens an active lifestyle and exposes the patient to risk of early osteoarthritis (OA). ACL reconstruction is typically chosen by individuals to allow a return to their previous work and sports activities. Primary ACL reconstruction (ACLR) has in general been effective at restoring functional stability, but patients' modifiable predictors of both short- and long-term validated outcomes and OA are largely unknown. The Multicenter Orthopaedic Outcomes Network (MOON) consortium was established in 2002 to enroll and longitudinally follow a population cohort of ACL reconstructed patients. The objective was to establish patient-specific predictive models of clinically important outcomes. Over the past 10 years, the overarching aims of this NIAMS-funded prospective multicenter cohort of ACL reconstructions has been threefold: (1) to identify both short- and long-term prognosis and predictors of sports function, activity level, and general health through validated patient-reported outcomes, (2) to identify the symptoms and signs of OA, and (3) to quantify the incidence of ACL reconstruction graft and/or contralateral ACL failures and additional surgical procedures. This manuscript summarizes the Kappa Delta Ann Doner Vaughan Award paper and presentation at the 2012 ORS/AAOS Annual Meeting. PMID:22912340

  14. Pre-Transplant Cardiovascular Risk Factors Affect Kidney Allograft Survival: A Multi-Center Study in Korea

    Science.gov (United States)

    Lee, Jung Pyo; Bae, Eunjin; Kang, Eunjeong; Kim, Hack-Lyoung; Kim, Yong-Jin; Oh, Yun Kyu; Kim, Yon Su; Kim, Young Hoon; Lim, Chun Soo

    2016-01-01

    Background Pre-transplant cardiovascular (CV) risk factors affect the development of CV events even after successful kidney transplantation (KT). However, the impact of pre-transplant CV risk factors on allograft failure (GF) has not been reported. Methods and Findings We analyzed the graft outcomes of 2,902 KT recipients who were enrolled in a multi-center cohort from 1997 to 2012. We calculated the pre-transplant CV risk scores based on the Framingham risk model using age, gender, total cholesterol level, smoking status, and history of hypertension. Vascular disease (a composite of ischemic heart disease, peripheral vascular disease, and cerebrovascular disease) was noted in 6.5% of the patients. During the median follow-up of 6.4 years, 286 (9.9%) patients had developed GF. In the multivariable-adjusted Cox proportional hazard model, pre-transplant vascular disease was associated with an increased risk of GF (HR 2.51; 95% CI 1.66–3.80). The HR for GF (comparing the highest with the lowest tertile regarding the pre-transplant CV risk scores) was 1.65 (95% CI 1.22–2.23). In the competing risk model, both pre-transplant vascular disease and CV risk score were independent risk factors for GF. Moreover, the addition of the CV risk score, the pre-transplant vascular disease, or both had a better predictability for GF compared to the traditional GF risk factors. Conclusions In conclusion, both vascular disease and pre-transplant CV risk score were independently associated with GF in this multi-center study. Pre-transplant CV risk assessments could be useful in predicting GF in KT recipients. PMID:27501048

  15. ANÁLISIS DE “BUENAS PRÁCTICAS” DEL E-LEARNING EN LAS UNIVERSIDADES ANDALUZAS ANALYSIS OF "BEST PRACTICES" OF E-LEARNING IN ANDALUSIAN UNIVERSITIES

    Directory of Open Access Journals (Sweden)

    Julio Cabero Almenara

    2010-02-01

    Full Text Available Este artículo ofrece los resultados obtenidos del analisis de “buenas prácticas” de treinta profesores de las diferentes Universidades Andaluzas. Para la recogida de datos se han utilizado tres instrumentos: biograma, entrevistas individualizadas y observación de materiales. Estos profesores tienen una actitud positiva hacia la formación e-learning, trabajan en grupo y llevan más de 2 años impartiéndolas junto a la presencial. Consideran esta formación como una gran ayuda para los alumnos por el volumen de material disponible, la flexibilización en su uso, la posibilidad de consulta y el trato es más personal. Por otro lado, estos profesores señalan la cantidad de tiempo y esfuerzo que requiere la elaboración y actualización de los materiales. Así como la escasa formación para su utilización didáctica y educativa, subsanada por su autoformación. Los materiales utilizados son considerados como buenos en lo técnico, didáctico y comunicativo.This article provides the results of the analysis of "best practices" of thirty teachers of different Andalusian Universities. For the collection of data we have been used three instruments: biogram, individualized interviews and observation of materials. These teachers have a positive attitude towards e-learning, working in groups and carry more than 2 years teaching with (together the face to face. They consider this training as a high help to students because of the high volume of available material, application flexibility, the possibility of consultation and the treatment is more personal. Moreover, these teachers pointed out the amount of time and effort required for the preparation and updating of materials, and also here poor training for teaching and educational use, that is remedied by themselves. The materials used are is adecuated in the technical, teaching and in the communication way.

  16. The IDEFICS Cohort

    DEFF Research Database (Denmark)

    Ahrens, Wolfgang; Bammann, Karin; Siani, Alfonso;

    2011-01-01

    tests. The proportion of children donating venous blood, urine and saliva was 57, 86 and 88%, respectively. Conclusion: The IDEFICS cohort provides valuable data to investigate the interplay of social, environmental, genetic, physiological and behavioural factors in the development of major diet- and...... children included anthropometry, blood pressure, fitness, accelerometry, DNA from saliva and physiological markers in blood and urine. The built environment, sensory taste perception and other mechanisms of children's food choices and consumer behaviour were studied in subgroups. Results: Between 1507 and....... At least one 24-h dietary recall was obtained for two-thirds of the children. Blood pressure and anthropometry were assessed in more than 90%. A 3-day accelerometry was performed in 46%, motor fitness was assessed in 41%, cardiorespiratory fitness in 35% and ~11% participated in taste perception...

  17. Unique features of HLA-mediated HIV evolution in a Mexican cohort: a comparative study

    Directory of Open Access Journals (Sweden)

    Brumme Zabrina L

    2009-08-01

    Full Text Available Abstract Background Mounting evidence indicates that HLA-mediated HIV evolution follows highly stereotypic pathways that result in HLA-associated footprints in HIV at the population level. However, it is not known whether characteristic HLA frequency distributions in different populations have resulted in additional unique footprints. Methods The phylogenetic dependency network model was applied to assess HLA-mediated evolution in datasets of HIV pol sequences from free plasma viruses and peripheral blood mononuclear cell (PBMC-integrated proviruses in an immunogenetically unique cohort of Mexican individuals. Our data were compared with data from the IHAC cohort, a large multi-center cohort of individuals from Canada, Australia and the USA. Results Forty three different HLA-HIV codon associations representing 30 HLA-HIV codon pairs were observed in the Mexican cohort (q Conclusion Our data support universal HLA-mediated HIV evolution at the population level, resulting in detectable HLA-associated footprints in the circulating virus. However, it also strongly suggests that unique genetic backgrounds in different HIV-infected populations may influence HIV evolution in a particular direction as particular HLA-HIV codon associations are determined by specific HLA frequency distributions. Our analysis also suggests a dynamic HLA-associated evolution in HIV with fewer HLA-HIV codon associations observed in the proviral compartment, which is likely enriched in early archived HIV sequences, compared to the plasma virus compartment. These results highlight the importance of comparative HIV evolutionary studies in immunologically different populations worldwide.

  18. Advancing the evidence base in cancer: psychosocial multicenter trials

    Directory of Open Access Journals (Sweden)

    Sanson-Fisher Robert

    2012-09-01

    Full Text Available Abstract Background The diagnosis and treatment of cancer is associated with significant distress and psychosocial morbidity. Although psychosocial interventions have been developed in an attempt to improve psychosocial outcomes in cancer patients and survivors, there is continued debate about whether there is adequate high-level evidence to establish the effectiveness of these interventions. The evidence base is limited as a result of numerous challenges faced by those attempting to conduct psychosocial intervention trials within the health system. Barriers include insufficient participant recruitment, difficulty generalizing from single-trial studies, difficulty in building and managing research teams with multidisciplinary expertise, lack of research design expertise and a lack of incentives for researchers conducting intervention research. To strengthen the evidence base, more intervention studies employing methodologically rigorous research designs are necessary. Methods In order to advance the evidence base of interventions designed to improve psychosocial outcomes for cancer patients and survivors, we propose the formation of a collaborative trials group that conducts multicenter trials to test the effectiveness of such interventions. Results Establishment of such a group would improve the quality of the evidence base in psychosocial research in cancer patients, by increasing support for conducting intervention research and providing intervention research training opportunities. A multidisciplinary collaborative group conducting multicenter trials would have the capacity to overcome many of the barriers that currently exist. Conclusions A stronger evidence base is necessary to identify effective psychosocial interventions for cancer patients. The proposed formation of a psycho-oncology collaborative trials group that conducts multicenter trials to test the effectiveness of psychosocial interventions would assist in achieving this outcome.

  19. Multicenter R2* mapping in the healthy brain

    DEFF Research Database (Denmark)

    Ropele, Stefan; Wattjes, Mike P; Langkammer, Christian; Kilsdonk, Iris D; de Graaf, Wolter L; Frederiksen, Jette L; Fuglø, Dan; Yiannakas, Marios; Wheeler-Kingshott, Claudia A M; Enzinger, Christian; Rocca, Maria A; Sprenger, Till; Amman, Michael; Kappos, Ludwig; Filippi, Massimo; Rovira, Alex; Ciccarelli, Olga; Barkhof, Frederik; Fazekas, Franz

    2014-01-01

    PURPOSE: The R2* relaxation rate constant has been suggested as a sensitive measure for iron accumulation. The aim of this multi-center study was to assess the inter-scanner and inter-subject variability of R2* mapping and to investigate the relationship between brain volume and R2* in specific...... structures. METHODS: R2* mapping was performed in 81 healthy subjects in seven centers using different 3 T systems. R2* was calculated from a dual-echo gradient echo sequence and was assessed in several deep gray matter structures. The inter-scanner and inter-subject variability of R2* was calculated by...

  20. Initial experiences of a multicenter transluminal revascularization registry

    International Nuclear Information System (INIS)

    This paper establishes a multicenter registry for collection and analysis of data from a large series of patients undergoing percutaneous transluminal revascularization of peripheral vascular lesions. The registry began as a joint collaboration between the radiology departments of Thomas Jefferson University Hospital and the University of Pennsylvania, through the Philadelphia Society of Angiography/Interventional Radiology. The American College of Radiology research office in Philadelphia is used as the data collection center. A detailed data form has been developed. It includes information about patient history, procedure indications, lesion location and morphology, techniques used, immediate angiographic and clinical outcome, and clinical follow-up at intervals up to 5 years

  1. A multicenter evaluation of the Biotest legionella urinary antigen EIA

    DEFF Research Database (Denmark)

    Harrison, Timothy; Uldum, Søren; Alexiou-Daniel, Stella;

    1998-01-01

    OBJECTIVES: To undertake a multicenter study to evaluate the Biotest legionella urinary antigen enzyme immunoassay (EIA) performance against those EIAs already in use in 14 European laboratories. METHODS: Each laboratory examined urine specimens from appropriate patients using both their current...... laboratories' current EIAs, and in 94.6% of those specimens which were positive for Legionella pneumophila serogroup 1. CONCLUSION: The Biotest EIA is simple to use and specific and the results obtained in different laboratories show excellent agreement. The assay compares well existing EIAs, at least for L...

  2. SOD1 mutations in amyotrophic lateral sclerosis. Results from a multicenter Italian study.

    Science.gov (United States)

    Battistini, Stefania; Giannini, Fabio; Greco, Giuseppe; Bibbò, Giuseppe; Ferrera, Loreta; Marini, Valeria; Causarano, Renzo; Casula, Michela; Lando, Giuliana; Patrosso, Maria Cristina; Caponnetto, Claudia; Origone, Paola; Marocchi, Alessandro; Del Corona, Alberto; Siciliano, Gabriele; Carrera, Paola; Mascia, Vincenzo; Giagheddu, Marcello; Carcassi, Carlo; Orrù, Sandro; Garrè, Cecilia; Penco, Silvana

    2005-07-01

    Amyotrophic Lateral Sclerosis (ALS), the most common form among motoneuron diseases, is characterized by a progressive neurodegenerative process involving motor neurons in the motor cortex, brain stem and spinal cord. Sporadic (SALS) accounts for the majority of patients but in about 10% of ALS cases the disease is inherited (FALS), usually as an autosomal dominant trait. In the present study we show the results of a referred based multicenter study on the distribution of SOD1 gene mutations in the largest cohort of Italian ALS patients described so far. Two hundred and sixty-four patients (39 FALS and 225 SALS) of Italian origin were studied. In 7 out of 39 FALS patients we found the following SOD1 gene mutations: i) a new G12R missense mutation in exon 1, found in a patient with a slowly progressive disease course; ii) the G41S mutation, in four unrelated patients with rapidly progressive course complicated with cognitive decline in two of them; iii) the L114F mutation, in a patient with a slowly progressive phenotype; iv) the D90A mutation, in a heterozygous patient with atypical phenotype. In addition, in one SALS patient a previously reported synonymous variant S59S was identified. In 17 (3 FALS and 14 SALS) out of 264 patients (6.4 %) the polymorphism A-->C at position 34 of intron 3 (IVS3: + 34 A-->C) was found, and in one FALS patient a novel variant IVS3 + 62 T-->C was identified. The frequency of SOD1 gene mutations (17.9 %) in FALS cases was comparable with that found in other surveys with a similar sample size of ALS cases. No SOD1 gene mutations have been identified in SALS cases. Within FALS cases, The most frequent mutation was the G41S identified in four FALS. PMID:15789135

  3. Mastocytosis among elderly patients: A multicenter retrospective French study on 53 patients.

    Science.gov (United States)

    Rouet, Audrey; Aouba, Achille; Damaj, Gandhi; Soucié, Erinn; Hanssens, Katia; Chandesris, Marie-Olivia; Livideanu, Cristina Bulai; Dutertre, Marine; Durieu, Isabelle; Grandpeix-Guyodo, Catherine; Barète, Stéphane; Bachmeyer, Claude; Soria, Angèle; Frenzel, Laurent; Fain, Olivier; Grosbois, Bernard; de Gennes, Christian; Hamidou, Mohamed; Arlet, Jean-Benoit; Launay, David; Lavigne, Christian; Arock, Michel; Lortholary, Olivier; Dubreuil, Patrice; Hermine, Olivier; Georgin-Lavialle, Sophie

    2016-06-01

    Mastocytosis is a heterogeneous group of diseases with a young median age at diagnosis. Usually indolent and self-limited in childhood, the disease can exhibit aggressive progression in mid-adulthood. Our objectives were to describe the characteristics of the disease when diagnosed among elderly patients, for which rare data are available.The French Reference Center conducted a retrospective multicenter study on 53 patients with mastocytosis >69 years of age, to describe their clinical, biological, and genetic features.The median age of our cohort of patients was 75 years. Mastocytosis variants included were cutaneous (n = 1), indolent systemic (n = 5), aggressive systemic (n = 11), associated with a hematological non-mast cell disease (n = 34), and mast cell leukemia (n = 2). Clinical manifestations were predominantly mast cell activation symptoms (75.5%), poor performance status (50.9%), hepatosplenomegaly (50.9%), skin involvement (49.1%), osteoporosis (47.2%), and portal hypertension and ascites (26.4%). The main biological features were anemia (79.2%), thrombocytopenia (50.9%), leucopenia (20.8%), and liver enzyme abnormalities (32.1%). Of the 40 patients tested, 34 (85%), 2 (5%), and 4 (10%) exhibited the KIT D816V mutant, other KIT mutations and the wild-type form of the KIT gene, respectively. Additional sequencing detected significant genetic defects in 17 of 26 (65.3%) of the patients with associated hematological non-mast cell disease, including TET2, SRSF2, IDH2, and ASLX1 mutations. Death occurred in 19 (35.8%) patients, within a median delay of 9 months, despite the different treatment options available.Mastocytosis among elderly patients has a challenging early detection, rare skin involvement, and/or limited skin disease; it is heterogeneous and has often an aggressive presentation with nonfortuitous associated myeloid lineage malignant clones, and thus a poor overall prognosis. PMID:27310990

  4. Multicenter study of high-dose daptomycin for treatment of enterococcal infections.

    Science.gov (United States)

    Casapao, Anthony M; Kullar, Ravina; Davis, Susan L; Levine, Donald P; Zhao, Jing J; Potoski, Brian A; Goff, Debra A; Crank, Christopher W; Segreti, John; Sakoulas, George; Cosgrove, Sara E; Rybak, Michael J

    2013-09-01

    Enterococci are among the leading pathogens isolated in hospital-acquired infections. Current antimicrobial options for vancomycin-resistant enterococci (VRE) are limited. Prior data suggest that daptomycin at >6 mg/kg of body weight/day may be used to treat enterococcal infections. We retrospectively evaluated the effectiveness and safety of high-dose daptomycin (HD-daptomycin) therapy (>6 mg/kg) in a multicenter cohort of adult patients with enterococcal infections to describe the characteristics and outcomes. Two hundred forty-five patients were evaluated. Enterococcus faecium was identified in 175 (71%), followed by Enterococcus faecalis in 49 (20%) and Enterococcus spp. in 21 (9%); overall, 204 (83%) isolates were VRE. Enterococcal infections included bacteremia (173, 71%) and intra-abdominal (35, 14%) and bone and joint (25, 10%) infections. The median dosage and duration of HD-daptomycin were 8.2 mg/kg/day (interquartile range [IQR], 7.7 to 9.7) and 10 days (IQR, 6 to 15), respectively. The overall clinical success rate was 89% (193/218), and microbiological eradication was observed in 93% (177/191) of patients. The median time to clearance of blood cultures on HD-daptomycin was 3 days (IQR, 2 to 5). The 30-day all-cause mortality rate was 27%, and 5 (2%) patients developed daptomycin-nonsusceptible enterococcal strains while on HD-daptomycin. Seven patients (3%) had creatine phosphokinase (CPK) elevation, yet no HD-daptomycin regimen was discontinued due to an elevated CPK and all patients were asymptomatic. Overall, there was a high frequency of clinical success and microbiological eradication in patients treated with HD-daptomycin for enterococcal infections, even in patients with complicated and difficult-to-treat infections. No adverse event-related discontinuation of HD-daptomycin was noted. HD-daptomycin may be an option for the treatment of enterococcal infections. PMID:23774437

  5. Immune checkpoint blockade with concurrent electrochemotherapy in advanced melanoma: a retrospective multicenter analysis.

    Science.gov (United States)

    Heppt, Markus V; Eigentler, Thomas K; Kähler, Katharina C; Herbst, Rudolf A; Göppner, Daniela; Gambichler, Thilo; Ulrich, Jens; Dippel, Edgar; Loquai, Carmen; Schell, Beatrice; Schilling, Bastian; Schäd, Susanne G; Schultz, Erwin S; Matheis, Fanny; Tietze, Julia K; Berking, Carola

    2016-08-01

    Growing evidence suggests that concurrent loco-regional and systemic treatment modalities may lead to synergistic anti-tumor effects in advanced melanoma. In this retrospective multicenter study, we evaluate the use of electrochemotherapy (ECT) combined with ipilimumab or PD-1 inhibition. We investigated patients with unresectable or metastatic melanoma who received the combination of ECT and immune checkpoint blockade for distant or cutaneous metastases within 4 weeks. Clinical and laboratory data were collected and analyzed with respect to safety and efficacy. A total of 33 patients from 13 centers were identified with a median follow-up time of 9 months. Twenty-eight patients received ipilimumab, while five patients were treated with a PD-1 inhibitor (pembrolizumab n = 3, nivolumab n = 2). The local overall response rate (ORR) was 66.7 %. The systemic ORR was 19.2 and 40.0 % in the ipilimumab and PD-1 cohort, respectively. The median duration of response was not reached in either group. The median time to disease progression was 2.5 months for the entire population with 2 months for ipilimumab and 5 months for PD-1 blockade. The median overall survival was not reached in patients with ipilimumab and 15 months in the PD-1 group. Severe systemic adverse events were detected in 25.0 % in the ipilimumab group. No treatment-related deaths were observed. This is the first reported evaluation of ECT and simultaneous PD-1 inhibition and the largest published dataset on ECT with concurrent ipilimumab. The local response was lower than reported for ECT only. Ipilimumab combined with ECT was feasible, tolerable and showed a high systemic response rate. PMID:27294607

  6. Review of rank-based procedures for multicenter clinical trials.

    Science.gov (United States)

    Rashid, M Mushfiqur; McKean, Joseph W; Kloke, John D

    2013-01-01

    This article reviews nonparametric alternatives to the mixed model normal theory analysis for the analyses of multicenter clinical trials. Under a mixed model, the traditional analysis is based on maximum likelihood theory under normal errors. This analysis, though, is not robust to outliers. Robust, rank-based, Wilcoxon-type procedures are reviewed for a multicenter clinical trial for the mixed model but without the assumption of normality. These procedures retain the high efficiency of Wilcoxon methods for simple location problems and are based on a fitting criterion which is robust to outliers in response space. A simple weighting scheme can be employed so that the procedures are robust to outliers in factor (design) space as well as response space. These rank-based analyses offer a complete analysis, including estimation of fixed effects and their standard errors, and tests of linear hypotheses. Both rank-based estimates of contrasts and individual treatment effects are reviewed. We illustrate the analyses using real data from a clinical trial. PMID:24138428

  7. Chest radiographic data acquisition and quality assurance in multicenter studies

    International Nuclear Information System (INIS)

    Background. Multicenter studies rely on data derived from different institutions. Forms can be designed to standardize the reporting process allowing reliable comparison of data. Objective. The purpose of the report is to provide a standardized method, developed as a part of a multicenter study of vertically transmitted HIV, for assessing chest radiographic results. Materials and methods. Eight hundred and five infants and children were studied at five centers; 3057 chest radiographs were scored. Data were entered using a forced-choice, graded response for 12 findings. Quality assurance measures and inter-rater agreement statistics are reported. Results. The form used for reporting chest radiographic results is presented. Inter-rater agreement was moderate to high for most findings, with the best correlation reported for the presence of bronchovascular markings and/or reticular densities addressed as a composite question (kappa = 0.71). The presence of nodular densities (kappa 0.56) and parenchymal consolidation (kappa = 0.57) had moderate agreement. Agreement for lung volume was low. Conclusion. The current tool, developed for use in the pediatric population, is applicable to any study involving the assessment of pediatric chest radiographs for a large population, whether at one or many centers. (orig.)

  8. Cohort Profile Update: The China Jintan Child Cohort Study.

    Science.gov (United States)

    Liu, Jianghong; Cao, Siyuan; Chen, Zehang; Raine, Adrian; Hanlon, Alexandra; Ai, Yuexian; Zhou, Guoping; Yan, Chonghuai; Leung, Patrick W; McCauley, Linda; Pinto-Martin, Jennifer

    2015-10-01

    The China Jintan Child Cohort study began in 2004 with 1656 pre-school participants and a research focus on studying the impact of environmental exposures, such as lead, on children's neurobehavioural outcomes. This population cohort now includes around 1000 of the original participants, who have been assessed three times over a period of 10 years. Since the original IJE cohort profile publication in 2010, participants have experienced a critical developmental transition from pre-school to school age and then adolescence. The study has also witnessed an increase in breadth and depth of data collection from the original aim of risk assessment. This cohort has added new directions to investigate the mechanisms and protective factors for the relationship between early health factors and child physical and mental health outcomes, with an emphasis on neurobehavioural consequences. The study now encompasses 11 domains, composed of repeated measures of the original variables and new domains of biomarkers, sleep, psychophysiology, neurocognition, personality, peer relationship, mindfulness and family dynamics. Depth of evaluation has increased from parent/teacher report to self/peer report and intergenerational family report. Consequently, the cohort has additional directions to include: (i) classmates of the original cohort participants for peer relationship assessment; and (ii) parental and grandparental measures to assess personality and dynamics within families. We welcome interest in our study and ask investigators to contact the corresponding author for additional information on data acquisition. PMID:26323725

  9. Imputation of the Date of HIV Seroconversion in a Cohort of Seroprevalent Subjects: Implications for Analysis of Late HIV Diagnosis

    Directory of Open Access Journals (Sweden)

    Paz Sobrino-Vegas

    2012-01-01

    Full Text Available Objectives. Since subjects may have been diagnosed before cohort entry, analysis of late HIV diagnosis (LD is usually restricted to the newly diagnosed. We estimate the magnitude and risk factors of LD in a cohort of seroprevalent individuals by imputing seroconversion dates. Methods. Multicenter cohort of HIV-positive subjects who were treatment naive at entry, in Spain, 2004–2008. Multiple-imputation techniques were used. Subjects with times to HIV diagnosis longer than 4.19 years were considered LD. Results. Median time to HIV diagnosis was 2.8 years in the whole cohort of 3,667 subjects. Factors significantly associated with LD were: male sex; Sub-Saharan African, Latin-American origin compared to Spaniards; and older age. In 2,928 newly diagnosed subjects, median time to diagnosis was 3.3 years, and LD was more common in injecting drug users. Conclusions. Estimates of the magnitude and risk factors of LD for the whole cohort differ from those obtained for new HIV diagnoses.

  10. Cerebral palsy and placental infection: a case-cohort study

    Directory of Open Access Journals (Sweden)

    Khong T Yee

    2004-01-01

    Full Text Available Abstract Background The association between cerebral palsy in very preterm infants and clinical, histopathologic and microbiological indicators of chorioamnionitis, including the identification of specific micro-organisms in the placenta, was evaluated in a case-cohort study. Methods Children with a diagnosis of cerebral palsy at five years of age were identified from amongst participants in a long-term follow-up program of preterm infants. The comparison group was a subcohort of infants randomly selected from all infants enrolled in the program. The placentas were examined histopathologically for chorioamnionitis and funisitis, and the chorioamnionic interface was aseptically swabbed and comprehensively cultured for aerobic and anaerobic bacteria, yeast and genital mycoplasmas. Associations between obstetric and demographic variables, indicators of chorioamnionitis and cerebral palsy status were examined by univariate analysis. Results Eighty-two infants with cerebral palsy were compared with the subcohort of 207 infants. Threatened preterm labor was nearly twice as common among the cases as in the subcohort (p E. coli was cultured from the placenta in 6/30 (20% of cases as compared with 4/85 (5% of subcohort (p = 0.01. Group B Streptococcus was more frequent among the cases, but the difference was not statistically significant. Conclusions The association between E. coli in the chorioamnion and cerebral palsy in preterm infants identified in this study requires confirmation in larger multicenter studies which include microbiological study of placentas.

  11. Should we use laparoscopic adrenalectomy for metastases? Scandinavian multicenter study

    DEFF Research Database (Denmark)

    Marangos, Irina Pavlik; Kazaryan, Airazat M; Rosseland, Arne R;

    2009-01-01

    INTRODUCTION: Laparoscopic adrenalectomy for metastases is considered controversial. Multicenter retrospective study was performed to gain new knowledge in this issue. MATERIALS AND METHODS: From January 1997 till November 2008, 41 adrenalectomies were performed during follow-up of the patients...... operated for malignant tumors. The median age was 64 (52-77) years. Metastases were confirmed in 31/41 cases. Metastatic lesions were further studied and to define factors influencing on survival, patients were divided to sub-groups of metachronous/synchronous, tumor origin and tumor size. RESULTS: The...... carcinoma, 5 lung carcinoma, 4 melanoma, and 1 hepatocellular metastases. The resection margin was not free in one case (3.7%). The median hospital stay was 2 (1-21) days. The median length of survival was 29 +/- 2.1 months for all patients. CONCLUSION: Laparoscopic adrenalectomy for metastases is feasible...

  12. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P;

    2000-01-01

    OBJECTIVE: The goals for maintenance dialysis treatment are to improve patient survival, reduce patient morbidity, and improve patient quality of life. This is the first randomized prospective study comparing automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD......) treatment with respect to quality of life and clinical outcomes in relation to therapy costs. DESIGN: A prospective, randomized multicenter study. SETTING: Three Danish CAPD units. PATIENTS: Thirty-four adequately dialyzed patients with high or high-average peritoneal transport characteristics were included...... in the study.Twenty-five patients completed the study. INTERVENTIONS: After randomization, 17 patients were allocated to APD treatment and 17 patients to CAPD treatment for a period of 6 months. Medical and biochemical parameters were evaluated at monthly controls in the CAPD units. Quality-of-life parameters...

  13. Congenital cholesteatoma of mastoid origin: A multicenter case series

    Directory of Open Access Journals (Sweden)

    Čvorović Ljiljana

    2014-01-01

    Full Text Available Background/Aim. The mastoid is the rarest site for the onset of congenital cholesteatoma (CC. The symptoms are atypical and minimal. The aim of this multicenter retrospective descriptive study was to define this extremely rare condition and its clinical presentation, diagnosis and management. Methods. We analyzed data files for a 15- year period in 4 tertiary otology centers and discovered 6 patients with the diagnosis of CC of the mastoid. Results. The clinical presentation of CC varied from incidental findings in patient to patient with otogenic meningitis. The most common findings during surgical procedures were mastoid cortex erosion, sigmoid plate dehiscence, dural exposure and external canal wall destruction. Conclusion. CC of mastoid origin tends to occur in adult patients probably because of minimal symptoms and the delayed diagnosis. It can exist for years in a nonaggressive state and develop to giant sizes. In children it is almost incidentally diagnosed. Early imaging is necessary in order to prevent serious complication.

  14. A Canadian multicenter, double-blind study of paroxetine and fluoxetine in major depressive disorder

    NARCIS (Netherlands)

    Chouinard, G; Saxena, B; Belanger, MC; Ravindran, A; Bakish, D; Beauclair, L; Morris, P; Nair, NPV; Manchanda, R; Reesal, R; Remick, R; O'Neill, MC

    1999-01-01

    Background: Recent studies have suggested clinical differences among selective serotonin reuptake inhibitors. In a 12-week randomized, multicenter, double-blind trial, the antidepressant and anxiolytic efficacy of the selective serotonin reuptake inhibitors paroxetine and fluoxetine was compared in

  15. The filtering, clear-cornea diathermal keratostomy: a minor Danish multicenter study

    DEFF Research Database (Denmark)

    Kessing, S.V.; Nissen, O.I.; Thygesen, J.; Flesner, P.; Otland, N.; Riise, P.

    2008-01-01

    PURPOSE: Is the new micropenetrating, clear-cornea procedure, intrastromal diathermal keratostomy (IDK), an alternative to the intricate "modern trabeculectomy"? METHODS: Prospective multicenter study. Four surgeons from 4 Danish eye departments attended an IDK course and subsequently decided whe...

  16. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study

    Directory of Open Access Journals (Sweden)

    Kristen Meldi Plasseraud

    2016-01-01

    Full Text Available Uveal melanoma management is challenging due to its metastatic propensity. DecisionDx-UM is a prospectively validated molecular test that interrogates primary tumor biology to provide objective information about metastatic potential that can be used in determining appropriate patient care. To evaluate the continued clinical validity and utility of DecisionDx-UM, beginning March 2010, 70 patients were enrolled in a prospective, multicenter, IRB-approved study to document patient management differences and clinical outcomes associated with low-risk Class 1 and high-risk Class 2 results indicated by DecisionDx-UM testing. Thirty-seven patients in the prospective study were Class 1 and 33 were Class 2. Class 1 patients had 100% 3-year metastasis-free survival compared to 63% for Class 2 (log rank test p=0.003 with 27.3 median follow-up months in this interim analysis. Class 2 patients received significantly higher-intensity monitoring and more oncology/clinical trial referrals compared to Class 1 patients (Fisher’s exact test p=2.1×10-13 and p=0.04, resp.. The results of this study provide additional, prospective evidence in an independent cohort of patients that Class 1 and Class 2 patients are managed according to the differential metastatic risk indicated by DecisionDx-UM. The trial is registered with Clinical Application of DecisionDx-UM Gene Expression Assay Results (NCT02376920.

  17. Trabecular bone strength is not an independent predictive factor for dynamic hip screw migration--A prospective multicenter cohort study.

    Science.gov (United States)

    Müller, Marc A; Hengg, Clemens; Krettek, Christian; van der Velde, Detlef; Eberdorfer, Siegfried; Stange, Richard; Hofmann, Gunther O; Platz, Andreas; Suhm, Norbert

    2015-11-01

    This study assessed whether mechanically measured trabecular bone strength is an independent predictor of dynamic hip screw (DHS) stability, i.e., DHS migration (DHSM) after the fixation of proximal femoral fractures. One-hundred and seven patients older than 50 years with proximal femoral fractures were included. During fracture fixation, a mechanical probe (DensiProbe™ Hip) was inserted at the site where the DHS tip would ultimately be positioned. Peak torque to breakaway the trabecular bone was measured. Fracture reduction, primary implant position and postoperative DHSM were assessed by radiographs taken postoperatively, at 6 and 12 weeks after surgery. Univariate regression analysis revealed no association between peak torque and DHSM (R(2) = 0.025, p = 0.135). DHSM correlated with the primary DHS position, i.e., the distance between the DHS and (i) the central femoral neck axis (CNFAD, R(2) = 0.230; p screw migration. The primary implant position measured by the CFNAD, rather than DensiProbe™ Hip measured bone strength, is an independent predictor of DHSM. PMID:25929756

  18. Symptomatic reactions, clinical outcomes and patient satisfaction associated with upper cervical chiropractic care: A prospective, multicenter, cohort study

    Directory of Open Access Journals (Sweden)

    Hurwitz Eric L

    2011-10-01

    Full Text Available Abstract Background Observational studies have previously shown that adverse events following manipulation to the neck and/or back are relatively common, although these reactions tend to be mild in intensity and self-limiting. However, no prospective study has examined the incidence of adverse reactions following spinal adjustments using upper cervical techniques, and the impact of this care on clinical outcomes. Methods Consecutive new patients from the offices of 83 chiropractors were recruited for this practice-based study. Clinical outcome measures included 1 Neck pain disability index (100-point scale, 2 Oswestry back pain index (100-point scale, 3 11-point numerical rating scale (NRS for neck, headache, midback, and low back pain, 4 treatment satisfaction, and 5 Symptomatic Reactions (SR. Data were collected at baseline, and after approximately 2 weeks of care. A patient reaching sub-clinical status for pain and disability was defined as a follow-up score 30% based on an 11-point numeric rating scale occurring Results A total of 1,090 patients completed the study having 4,920 (4.5 per patient office visits requiring 2,653 (2.4 per patient upper cervical adjustments over 17 days. Three hundred thirty- eight (31.0% patients had SRs meeting the accepted definition. Intense SR (NRS ≥8 occurred in 56 patients (5.1%. Outcome assessments were significantly improved for neck pain and disability, headache, mid-back pain, as well as lower back pain and disability (p 5 million career upper cervical adjustments without a reported incidence of serious adverse event. Conclusions Upper cervical chiropractic care may have a fairly common occurrence of mild intensity SRs short in duration (

  19. Sex differences in substance use, health, and social functioning among opioid users receiving methadone treatment: a multicenter cohort study

    OpenAIRE

    Bawor, Monica; Brittany B. Dennis; Varenbut, Michael; Daiter, Jeff; David C. Marsh; Plater, Carolyn; Worster, Andrew; Steiner, Meir; Anglin, Rebecca; Pare, Guillaume; Desai, Dipika; Thabane, Lehana; Samaan, Zainab

    2015-01-01

    Background Despite the growing numbers of men and women with opioid use disorder in Canada, sex-specific issues in treatment have not been re-examined in the current population of patients with opioid addiction. We aimed to evaluate sex differences in substance use, health, and social functioning among men and women currently receiving methadone treatment for opioid use disorder in Ontario, Canada. Methods We recruited 503 participants with opioid dependence disorder receiving methadone maint...

  20. Macrolide use and the risk of vascular disease in HIV-infected men in the Multicenter AIDS Cohort Study

    DEFF Research Database (Denmark)

    Woolley, Ian J; Li, Xiuhong; Jacobson, Lisa P;

    2007-01-01

    event in the HAART era was also significant (0.10 [0.01-0.75]). CONCLUSIONS: Traditional risk factors are important in the pathogenesis of vascular events in HIV-infected individuals. Macrolide antibiotics may have a protective effect in the HIV-infected individuals in the HAART era. Udgivelsesdato......BACKGROUND: There has been increasing concern that HIV-infected individuals may be more at risk for cardiovascular events in the highly-active antiretroviral therapy (HAART) era. This study examined the risk of thromboembolic events in HIV-infected and non-infected individuals and the effect of...... scale with time varying cofactors obtained at each semi-annual visit were used to assess the independent effect of macrolide use. RESULTS: Controlling for other significant effects including race and smoking, HIV-infection was not independently associated with vascular events. Increased risk was...

  1. Multicenter Evaluation of a Nonweekend Reading Schedule for Radiometric Pyrazinamide Susceptibility Testing of Mycobacterium tuberculosis

    OpenAIRE

    Madison, B.; Gross, W.; George, I.; Sloutsky, A.; Washabaugh, G.; Robinson-Dunn, B.; Lipman, H; Metchock, B; Mazurek, G; Ridderhof, J.

    2002-01-01

    Pyrazinamide (PZA) is an integral component of the short-course chemotherapy regimen for tuberculosis. The BACTEC 460TB PZA susceptibility test for Mycobacterium tuberculosis with a daily (D) reading schedule has been available for more than 10 years, but weekend laboratory staffing is necessary. A nonweekend (NW) reading schedule has not been validated in a multicenter study. This prospective multicenter study compares the interlaboratory reproducibility of PZA susceptibility results by foll...

  2. Multi-Center Electronic Structure Calculations for Plasma Equation of State

    Energy Technology Data Exchange (ETDEWEB)

    Wilson, B G; Johnson, D D; Alam, A

    2010-12-14

    We report on an approach for computing electronic structure utilizing solid-state multi-center scattering techniques, but generalized to finite temperatures to model plasmas. This approach has the advantage of handling mixtures at a fundamental level without the imposition of ad hoc continuum lowering models, and incorporates bonding and charge exchange, as well as multi-center effects in the calculation of the continuum density of states.

  3. Multicenter study differentiated thyroid carcinoma (MSDS). Diminished acceptance of adjuvant external beam radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Biermann, M.; Pixberg, M.K.; Schober, O. [Muenster Univ. (Germany). Dept. of Nuclear Medicine; Schuck, A.; Willich, N. [Muenster Univ. (Germany). Dept. of Radiooncology; Heinecke, A.; Koepke, W. [Muenster Univ. (Germany). Dept. of Medical Informatics and Biomathematics; Schmid, K.W. [Essen Univ. (Germany). Dept. of Pathology; Dralle, H. [Halle-Wittenberg Univ., Halle (Germany). Dept. of Surgery

    2003-12-01

    Aim: The Multicenter Study Differentiated Thyroid Carcinoma (MSDS) is an ongoing study in Germany, Austria, and Switzerland on the clinical benefit of adjuvant external beam radiotherapy (RTx) for locally invasive differentiated thyroid carcinoma (DTC) in TNM stages pT4 pNO/1/xMO/x (5th ed. 1997). Methods: MSDS was designed as a prospective randomized trial. Patients receive thyroidectomy, radioiodine therapy (RIT) to ablate the thyroid remnant, and TSH-suppressive L-thyroxine therapy with or without RTx after documented elimination of cervical iodine-131 uptake (http://msds-studie.uni-muenster.de). Results: 311 patients were enrolled between January 2000 and March 2003. 279 patients met the trial's inclusion criteria. 45 consented to randomization, of whom 17 were randomized into treatment arm A (RTx) and 18 into arm B (no RTx). Advised by the trial's independent Data Monitoring and Safety Committee, the MSDS steering committee decided to terminate randomization in April 2003 and continue MSDS as a prospective cohort study. 23 of the 234 patients in the observation arm of the trial were prescribed RTx by their physicians. Thus, 14% of the trial cohort were randomized or assigned to receive RTx (intention-to-treat analysis). In contrast, at least 44% of all patients with pT4 papillary DTC in Germany in the nationwide PCES study underwent RTx in 1996 (p<0.001, {chi}{sup 2}-test). Conclusions: Acceptance of external beam RTx as a treatment modality for DTC has receded to a degree that accrual of a sufficient number of patients for a randomized trial has been impossible. Observation of the trial cohort is continued in order to assess clinical event rates with and without RTx and chronic RTx toxicity. (orig.) [German] Ziel: Die Multizentrische Studie Differenziertes Schilddruesenkarzinom (MSDS) ist eine laufende Studie in Deutschland, Oesterreich und der Schweiz zum klinischen Nutzen der adjuvanten perkutanen Strahlentherapie (RTx) bei lokal invasivem

  4. Methodology Series Module 1: Cohort Studies

    OpenAIRE

    Maninder Singh Setia

    2016-01-01

    Cohort design is a type of nonexperimental or observational study design. In a cohort study, the participants do not have the outcome of interest to begin with. They are selected based on the exposure status of the individual. They are then followed over time to evaluate for the occurrence of the outcome of interest. Some examples of cohort studies are (1) Framingham Cohort study, (2) Swiss HIV Cohort study, and (3) The Danish Cohort study of psoriasis and depression. These studies may be pro...

  5. Joint and Independent Associations of Gestational Weight Gain and Pre-Pregnancy Body Mass Index with Outcomes of Pregnancy in Chinese Women: A Retrospective Cohort Study

    OpenAIRE

    Li, Chunming; LIU, YAJUN; Zhang, Weiyuan

    2015-01-01

    Objective To explore the joint and independent effects of gestational weight gain (GWG) and pre-pregnancy body mass index (BMI) on pregnancy outcomes in a population of Chinese Han women and to evaluate pregnant women’s adherence to the 2009 Institute of Medicine (IOM) gestational weight gain guidelines. Methods This was a multicenter, retrospective cohort study of 48,867 primiparous women from mainland China who had a full-term singleton birth between January 1, 2011 and December 30, 2011. T...

  6. Biliary strictures and recurrence after liver transplantation for primary sclerosing cholangitis: A retrospective multicenter analysis.

    Science.gov (United States)

    Hildebrand, Tatiana; Pannicke, Nadine; Dechene, Alexander; Gotthardt, Daniel N; Kirchner, Gabriele; Reiter, Florian P; Sterneck, Martina; Herzer, Kerstin; Lenzen, Henrike; Rupp, Christian; Barg-Hock, Hannelore; de Leuw, Philipp; Teufel, Andreas; Zimmer, Vincent; Lammert, Frank; Sarrazin, Christoph; Spengler, Ulrich; Rust, Christian; Manns, Michael P; Strassburg, Christian P; Schramm, Christoph; Weismüller, Tobias J

    2016-01-01

    Liver transplantation (LT) is the only definitive treatment for patients with end-stage liver disease due to primary sclerosing cholangitis (PSC), but a high rate of biliary strictures (BSs) and of recurrent primary sclerosing cholangitis (recPSC) has been reported. In this multicenter study, we analyzed a large patient cohort with a long follow-up in order to evaluate the incidence of BS and recPSC, to assess the impact on survival after LT, and to identify risk factors. We collected clinical, surgical, and laboratory data and records on inflammatory bowel disease (IBD), immunosuppression, recipient and graft outcome, and biliary complications (based on cholangiography and histology) of all patients who underwent LT for PSC in 10 German transplant centers between January 1990 and December 2006; 335 patients (68.4% men; mean age, 38.9 years; 73.5% with IBD) underwent transplantation 8.8 years after PSC diagnosis with follow-up for 98.8 months. The 1-, 5-, and 10-year recipient and graft survival was 90.7%, 84.8%, 79.4% and 79.1%, 69.0%, 62.4%, respectively. BS was diagnosed in 36.1% after a mean time of 3.9 years, and recPSC was diagnosed in 20.3% after 4.6 years. Both entities had a significant impact on longterm graft and recipient survival. Independent risk factors for BS were donor age, ulcerative colitis, chronic ductopenic rejection, bilirubin, and international normalized ratio (INR) at LT. Independent risk factors for recPSC were donor age, IBD, and INR at LT. These variables were able to categorize patients into risk groups for BS and recPSC. In conclusion, BS and recPSC affect longterm graft and patient survival after LT for PSC. Donor age, IBD, and INR at LT are independent risk factors for BS and recPSC and allow for risk estimation depending on the recipient-donor constellation. PMID:26438008

  7. Surgical site infections in Italian Hospitals: a prospective multicenter study

    Directory of Open Access Journals (Sweden)

    Ippolito Giuseppe

    2008-03-01

    Full Text Available Abstract Background Surgical site infections (SSI remain a major clinical problem in terms of morbidity, mortality, and hospital costs. Nearly 60% of SSI diagnosis occur in the postdischarge period. However, literature provides little information on risk factors associated to in-hospital and postdischarge SSI occurrence. A national prospective multicenter study was conducted with the aim of assessing the incidence of both in-hospital and postdisharge SSI, and the associated risk factors. Methods In 2002, a one-month, prospective national multicenter surveillance study was conducted in General and Gynecological units of 48 Italian hospitals. Case ascertainment of SSI was carried out using standardized surveillance methodology. To assess potential risk factors for SSI we used a conditional logistic regression model. We also reported the odds ratios of in-hospital and postdischarge SSI. Results SSI occurred in 241 (5.2% of 4,665 patients, of which 148 (61.4% during in-hospital, and 93 (38.6% during postdischarge period. Of 93 postdischarge SSI, sixty-two (66.7% and 31 (33.3% were detected through telephone interview and questionnaire survey, respectively. Higher SSI incidence rates were observed in colon surgery (18.9%, gastric surgery (13.6%, and appendectomy (8.6%. If considering risk factors for SSI, at multivariate analysis we found that emergency interventions, NNIS risk score, pre-operative hospital stay, and use of drains were significantly associated with SSI occurrence. Moreover, risk factors for total SSI were also associated to in-hospital SSI. Additionally, only NNIS, pre-operative hospital stay, use of drains, and antibiotic prophylaxis were associated with postdischarge SSI. Conclusion Our study provided information on risk factors for SSI in a large population in general surgery setting in Italy. Standardized postdischarge surveillance detected 38.6% of all SSI. We also compared risk factors for in-hospital and postdischarge SSI

  8. Generational cohorts and their attitudes toward advertising

    OpenAIRE

    Ernest Cyril De Run; Hiram Ting

    2013-01-01

    This research is aimed at determining the attitudes with regard to advertising from the perspective of generational cohorts in Sarawak. A two-phase of study was conducted to firstly identify generational cohorts in the state and, secondly, to investigate the attitude of each cohort to advertising. Utilizing theories of generations, a qualitative approach by means of personal interviews was used at the outset to identify external events which bring about the formation of cohorts. Accordingly, ...

  9. A Cohort Model of Fertility Postponement

    OpenAIRE

    Joshua R. Goldstein; Cassidy, Thomas

    2014-01-01

    We introduce a new formal model in which demographic behavior such as fertility is postponed by differing amounts depending only on cohort membership. The cohort-based model shows the effects of cohort shifts on period fertility measures and provides an accompanying tempo adjustment to determine the period fertility that would have occurred without postponement. Cohort-based postponement spans multiple periods and produces “fertility momentum,” with implications for future fertility rates. We...

  10. A Study of Group Dynamics in Educational Leadership Cohort and Non-Cohort Groups

    Science.gov (United States)

    Greenlee, Bobbie J.; Karanxha, Zorka

    2010-01-01

    The purpose of this study was to examine group dynamics of educational leadership students in cohorts and make comparisons with the group dynamics characteristics of non-cohort students. Cohorts have emerged as dynamic and adaptive entities with attendant group dynamic processes that shape collective learning and action. Cohort (n=42) and…

  11. Moving the mandible in orthognathic surgery - A multicenter analysis.

    Science.gov (United States)

    Thiele, Oliver C; Kreppel, Matthias; Bittermann, Gido; Bonitz, Lars; Desmedt, Maria; Dittes, Carsten; Dörre, Annegret; Dunsche, Anton; Eckert, Alexander W; Ehrenfeld, Michael; Fleiner, Bernd; Frerich, Bernhard; Gaggl, Alexander; Gerressen, Marcus; Gmelin, Leonore; Hammacher, Andreas; Haßfeld, Stefan; Heiland, Max; Hemprich, Alexander; Hidding, Johannes; Hölzle, Frank; Howaldt, Hans-Peter; Iizuka, Tateyuki; Kater, Wolfgang; Klein, Cornelius; Klein, Martin; Köhnke, Robert H; Kolk, Andreas; Kübler, Alexander C; Kübler, Norbert R; Kunkel, Martin; Kuttenberger, Johannes J; Kreusch, Thomas; Landes, Constantin; Lehner, Bernhard; Mischkowski, Robert A; Mokros, Steffen; Neff, Andreas; Nkenke, Emeka; Palm, Frank; Paulus, Gerhard W; Piesold, Jörn U; Rasse, Michael; Rodemer, Herbert; Rothamel, Daniel; Rustemeyer, Jan; Sader, Robert; Scheer, Martin; Scheffler, Birgit; Schippers, Christian; Schliephake, Henning; Schmelzeisen, Rainer; Schramm, Alexander; Spitzer, Wolfgang J; Stoll, Christian; Terheyden, Hendrik; Weingart, Dieter; Wiltfang, Jörg; Wolff, Klaus D; Ziegler, Christoph M; Zöller, Joachim E

    2016-05-01

    Orthognathic surgery has always been a classical focus of maxillofacial surgery. Since more than 100 years, various surgical techniques for mandibular repositioning have been developed and clinically tested. Since the establishment of plate and screw osteosynthesis, orthognathic surgery became more stable and safe. Nowadays, different surgical methods for mobilising the mandible are existing. This international multicenter analysis (n = 51 hospitals) is providing first evidence based data for the current use of different surgical methods. The dominating techniques were Obwegeser/dal Pont (61%) followed by Hunsuck/Epker (37%) and Perthes/Schlössmann (29%). The main osteosynthesis materials were plates (82%), bicortical screws (23.5%), or a combination of both (5.9%). 47% of all centers reported to use several surgical methods at the same time, depending on the anatomical problem and the surgeon's preference. This shows that different surgical methods seem to work as comparable, safe, and reliable procedures in everydays clinical practise. On this basis, further prospective studies could evaluate possible advantages for our patients. PMID:27017103

  12. The Multi-Center Airborne Coherent Atmospheric Wind Sensor, MACAWS

    Science.gov (United States)

    Rothermel, Jeffry; Cutten, Dean R.; Hardesty, R. Michael; Menzies, Robert T.; Howell, James; Johnson, Steven C.; Tratt, David M.; Olivier, Lisa D.; Banta, Robert M.

    1997-01-01

    In 1992 the atmospheric lidar remote sensing groups of the NASA Marshall Space Flight Center, NOAA Environmental Technology Laboratory, and Jet Propulsion Laboratory began a joint collaboration to develop an airborne high-energy Doppler laser radar (lidar) system for atmospheric research and satellite validation and simulation studies. The result is the Multi-center Airborne Coherent Atmospheric Wind Sensor, MACAWS, which has the capability to remotely sense the distribution of wind and absolute aerosol backscatter in the troposphere and lower stratosphere. A factor critical to the programmatic feasibility and technical success of this collaboration has been the utilization of existing components and expertise which were developed for previous atmospheric research by the respective institutions. The motivation for the MACAWS program Is three-fold: to obtain fundamental measurements of sub-synoptic scale processes and features which may be used as a basis to improve sub-grid scale parameterizations in large-scale models; to obtain similar datasets in order to improve the understanding and predictive capabilities on the mesoscale; and to validate (simulate) the performance of existing (planned) satellite-borne sensors. Examples of the latter include participation in the validation of the NASA Scatterometer and the assessment of prospective satellite Doppler lidar for global tropospheric wind measurement. Initial flight tests were made in September 1995; subsequent flights were made in June 1996 following improvements. This paper describes the MACAWS instrument, principles of operation, examples of measurements over the eastern Pacific Ocean and western United States, and future applications.

  13. Multi-center airborne coherent atmospheric wind sensor (MACAWS)

    Energy Technology Data Exchange (ETDEWEB)

    Rothermel, J. [NASA Global Hydrology and Climate Center, Huntsville, AL (United States); Menzies, R.T.; Tratt, D.M. [California Inst. of Technology, Pasadena, CA (United States)

    1996-11-01

    The Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS) is an airborne scanning coherent Doppler lidar designed to acquire remote multi-dimensional measurements of winds and absolute aerosol backscatter in the troposphere and lower stratosphere. These measurements enable study of atmospheric dynamic processes and features at scales of motion that may be undersampled by, or may be beyond the capability of, existing or planned sensors. MACAWS capabilities enable more realistic assessments of concepts in global tropospheric wind measurement with satellite Doppler lidar, as well as a unique capability to validate the NASA Scatterometer currently scheduled for launch in late 1996. MACAWS consists of a Joule-class CO{sub 2} coherent Doppler lidar on a ruggedized optical table, a programmable scanner to direct the lidar beam in the desired direction, and a dedicated inertial navigation system to account for variable aircraft attitude and speed. MACAWS was flown for the first time in September 1995, over the eastern Pacific Ocean and western US. 33 refs., 2 figs.

  14. Prospective multicenter assessment of perioperative and minimum 2-year postoperative complication rates associated with adult spinal deformity surgery.

    Science.gov (United States)

    Smith, Justin S; Klineberg, Eric; Lafage, Virginie; Shaffrey, Christopher I; Schwab, Frank; Lafage, Renaud; Hostin, Richard; Mundis, Gregory M; Errico, Thomas J; Kim, Han Jo; Protopsaltis, Themistocles S; Hamilton, D Kojo; Scheer, Justin K; Soroceanu, Alex; Kelly, Michael P; Line, Breton; Gupta, Munish; Deviren, Vedat; Hart, Robert; Burton, Douglas C; Bess, Shay; Ames, Christopher P

    2016-07-01

    OBJECTIVE Although multiple reports have documented significant benefit from surgical treatment of adult spinal deformity (ASD), these procedures can have high complication rates. Previously reported complications rates associated with ASD surgery are limited by retrospective design, single-surgeon or single-center cohorts, lack of rigorous data on complications, and/or limited follow-up. Accurate definition of complications associated with ASD surgery is important and may serve as a resource for patient counseling and efforts to improve the safety of patient care. The authors conducted a study to prospectively assess the rates of complications associated with ASD surgery with a minimum 2-year follow-up based on a multicenter study design that incorporated standardized data-collection forms, on-site study coordinators, and regular auditing of data to help ensure complete and accurate reporting of complications. In addition, they report age stratification of complication rates and provide a general assessment of factors that may be associated with the occurrence of complications. METHODS As part of a prospective, multicenter ASD database, standardized forms were used to collect data on surgery-related complications. On-site coordinators and central auditing helped ensure complete capture of complication data. Inclusion criteria were age older than 18 years, ASD, and plan for operative treatment. Complications were classified as perioperative (within 6 weeks of surgery) or delayed (between 6 weeks after surgery and time of last follow-up), and as minor or major. The primary focus for analyses was on patients who reached a minimum follow-up of 2 years. RESULTS Of 346 patients who met the inclusion criteria, 291 (84%) had a minimum 2-year follow-up (mean 2.1 years); their mean age was 56.2 years. The vast majority (99%) had treatment including a posterior procedure, 25% had an anterior procedure, and 19% had a 3-column osteotomy. At least 1 revision was required in 82

  15. The Global Enteric Multicenter Study (GEMS): Impetus, Rationale, and Genesis

    OpenAIRE

    Myron M. Levine; Kotloff, Karen L.; Nataro, James P.; Muhsen, Khitam

    2012-01-01

    Diarrheal disease remains one of the top 2 causes of young child mortality in the developing world. Whereas improvements in water/sanitation infrastructure and hygiene can diminish transmission of enteric pathogens, vaccines can also hasten the decline of diarrheal disease morbidity and mortality. From 1980 through approximately 2004, various case/control and small cohort studies were undertaken to address the etiology of pediatric diarrhea in developing countries. Many studies had methodolog...

  16. Pregnancy and birth cohort resources in europe

    DEFF Research Database (Denmark)

    Larsen, Pernille Stemann; Kamper-Jørgensen, Mads; Adamson, Ashley;

    2013-01-01

    During the past 25 years, many pregnancy and birth cohorts have been established. Each cohort provides unique opportunities for examining associations of early-life exposures with child development and health. However, to fully exploit the large amount of available resources and to facilitate cross-cohort...... collaboration, it is necessary to have accessible information on each cohort and its individual characteristics. The aim of this work was to provide an overview of European pregnancy and birth cohorts registered in a freely accessible database located at http://www.birthcohorts.net....

  17. Consumer Cohorts and Milk Purchases

    OpenAIRE

    Gustavsen, Geir Waehler; Rickertsen, Kyrre

    2008-01-01

    Fluid milk is the most important product of Norwegian agriculture, and the decline in milk purchase has impact in many rural communities. By decomposing the milk purchase into cohort effects, age effects and year effects we show that the reason for the decline is that older generations purchase more milk than younger generations, and during lifetime consumption decline with age. Consequently, as younger generations replace older generations milk purchase decline. We show that towards 2021 the...

  18. The Multi-center Airborne Coherent Atmospheric Wind Sensor.

    Science.gov (United States)

    Rothermel, Jeffry; Cutten, Dean R.; Hardesty, R. Michael; Menzies, Robert T.; Howell, James N.; Johnson, Steven C.; Tratt, David M.; Olivier, Lisa D.; Banta, Robert M.

    1998-04-01

    In 1992 the atmospheric lidar remote sensing groups of the National Aeronautics and Space Administration Marshall Space Flight Center, the National Oceanic and Atmospheric Administration/Environmental Technology Laboratory (NOAA/ETL), and the Jet Propulsion Laboratory began a joint collaboration to develop an airborne high-energy Doppler laser radar (lidar) system for atmospheric research and satellite validation and simulation studies. The result is the Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS), which has the capability to remotely sense the distribution of wind and absolute aerosol backscatter in three-dimensional volumes in the troposphere and lower stratosphere.A factor critical to the programmatic feasibility and technical success of this collaboration has been the utilization of existing components and expertise that were developed for previous atmospheric research by the respective institutions. For example, the laser transmitter is that of the mobile ground-based Doppler lidar system developed and used in atmospheric research for more than a decade at NOAA/ETL.The motivation for MACAWS is threefold: 1) to obtain fundamental measurements of subsynoptic-scale processes and features to improve subgrid-scale parameterizations in large-scale models, 2) to obtain datasets in order to improve the understanding of and predictive capabilities for meteorological systems on subsynoptic scales, and 3) to validate (simulate) the performance of existing (planned) satellite-borne sensors.Initial flight tests were made in September 1995; subsequent flights were made in June 1996 following system improvements. This paper describes the MACAWS instrument, principles of operation, examples of measurements over the eastern Pacific Ocean and western United States, and future applications.

  19. Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS)

    Science.gov (United States)

    Rhothermel, Jeffry; Jones, W. D.; Dunkin, J. A.; McCaul, E. W., Jr.

    1993-01-01

    This effort involves development of a calibrated, pulsed coherent CO2 Doppler lidar, followed by a carefully-planned and -executed program of multi-dimensional wind velocity and aerosol backscatter measurements from the NASA DC-8 research aircraft. The lidar, designated as the Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS), will be applicable to two research areas. First, MACAWS will enable specialized measurements of atmospheric dynamical processes in the planetary boundary layer and free troposphere in geographic locations and over scales of motion not routinely or easily accessible to conventional sensors. The proposed observations will contribute fundamentally to a greater understanding of the role of the mesoscale, helping to improve predictive capabilities for mesoscale phenomena and to provide insights into improving model parameterizations of sub-grid scale processes within large-scale circulation models. As such, it has the potential to contribute uniquely to major, multi-institutional field programs planned for the mid 1990's. Second, MACAWS measurements can be used to reduce the degree of uncertainty in performance assessments and algorithm development for NASA's prospective Laser Atmospheric Wind Sounder (LAWS), which has no space-based instrument heritage. Ground-based lidar measurements alone are insufficient to address all of the key issues. To minimize costs, MACAWS is being developed cooperatively by the lidar remote sensing groups of the Jet Propulsion Laboratory, NOAA Wave Propagation Laboratory, and MSFC using existing lidar hardware and manpower resources. Several lidar components have already been exercised in previous airborne lidar programs (for example, MSFC Airborne Doppler Lidar System (ADLS) used in 1981,4 Severe Storms Wind Measurement Program; JPL Airborne Backscatter Lidar Experiment (ABLE) used in 1989,90 Global Backscatter Experiment Survey Missions). MSFC has been given responsibility for directing the overall

  20. Cohort

    Czech Academy of Sciences Publication Activity Database

    Eben, Kryštof; Malý, Marek

    Chichester : John Wiley & Sons, 2004 - (Teugels, J.; Sundt, B.), s. 283-286 ISBN 0-470-84676-3 Institutional research plan: CEZ:AV0Z1030915 Keywords : bayesian statistics * censoring * competing risks * occurence/exposure rate * Wilkie investment model Subject RIV: AO - Sociology, Demography

  1. Creencias del profesorado sobre el significado de la tecnología en la enseñanza: influencia para su inserción en los centros docentes andaluces. [Teacher beliefs on the significance of technology in education: the influence for inclusion in the andalusian teaching centers].

    Directory of Open Access Journals (Sweden)

    Boza, Ángel

    2010-06-01

    Full Text Available This work shows results of an R & D Project of MCYT in Andalusian ICT Centers and its impact on teaching and learning processes. We conducted a survey to investigate the teachers´ beliefs about technology in education and its influence in the classroom. The data obtained provide evidence that we are close to the initial hypothesis, partially confirming that teacher beliefs about technology’s significance in education is related to its frequency and use as well as perceptions of organizational and curricular integration, and technological education and training. Este trabajo muestra resultados parciales de un Proyecto I+D de Ministerio de Ciencia y Tecnología español sobre centros TICs andaluces y sus repercusiones en los procesos de enseñanza-aprendizaje. Nos planteamos mediante encuesta indagar en las creencias del profesorado sobre la tecnología en la educación, su influencia en los procesos de aula. Los datos obtenidos nos aportan indicios que nos aproximan a la hipótesis inicial, confirmando parcialmente que las creencias que el profesorado tiene sobre el significado de las tecnologías en la educación se encuentran relacionadas con su frecuencia y uso, sus percepciones sobre la integración organizativa y curricular, y con su formación y capacitación tecnológica.

  2. The Danish National Birth Cohort

    DEFF Research Database (Denmark)

    Olsen, J; Melbye, M; Olsen, S F;

    2001-01-01

    component causes that act early in life. Exposures in this period, which influence fetal growth, cell divisions, and organ functioning, may have long-lasting impact on health and disease susceptibility. METHODS: To investigate these issues the Danish National Birth Cohort (Better health for mother and child......-pregnancy. Furthermore, a biological bank has been set up with blood taken from the mother twice during pregnancy and blood from the umbilical cord taken shortly after birth. Data collection started in 1996 and the project covered all regions in Denmark in 1999. By August 2000. a total of 60,000 pregnant women had been...

  3. The Significance of Tumoral ERCC1 Status in Patients With Locally Advanced Cervical Cancer Treated With Chemoradiation Therapy: A Multicenter Clinicopathologic Analysis

    International Nuclear Information System (INIS)

    Purpose: ERCC1 (excision repair cross-complementation group 1) expression has been shown to be a molecular marker of cisplatin resistance in many tumor sites, but has not been well studied in cervical cancer patients. The purpose of this study was to measure tumoral ERCC1 in patients with locally advanced cervical cancer treated with chemoradiation therapy (CRT) in a large multicenter cohort, and to correlate expression with clinical outcome parameters. Methods and Materials: A total of 264 patients with locally advanced cervical cancer, treated with curative-intent radical CRT from 3 major Canadian cancer centers were evaluated. Pretreatment formalin-fixed, paraffin-embedded tumor specimens were retrieved, and tissue microarrays were constructed. Tumoral ERCC1 (FL297 antibody) was measured using AQUA (R) technology. Statistical analysis was performed to determine the significance of clinical factors and ERCC1 status with progression-free survival (PFS) and overall survival (OS) at 5 years. Results: The majority of patients had International Federation of Gynecology and Obstetrics (FIGO) stage II disease (n=119, 45%); median tumor size was 5 cm. OS was associated with tumor size (HR 1.16, P=.018), pretreatment hemoglobin status (HR 2.33, P=.00027), and FIGO stage. In addition, tumoral ERCC1 status (nuclear to cytoplasmic ratio) was associated with PFS (HR 2.33 [1.05-5.18], P=.038) and OS (HR 3.13 [1.27-7.71], P=.013). ERCC1 status was not significant on multivariate analysis when the model was adjusted for the clinical factors: for PFS (HR 1.49 [0.61-3.6], P=.38); for OS (HR 2.42 [0.94-6.24] P=.067). Conclusions: In this large multicenter cohort of locally advanced cervical cancer patients treated with radical CRT, stage, tumor size, and pretreatment hemoglobin status were significantly associated with PFS and OS. ERCC1 status appears to have prognostic impact on univariate analysis in these patients, but was not independently associated with outcome on

  4. A cohort model of fertility postponement.

    Science.gov (United States)

    Goldstein, Joshua R; Cassidy, Thomas

    2014-10-01

    We introduce a new formal model in which demographic behavior such as fertility is postponed by differing amounts depending only on cohort membership. The cohort-based model shows the effects of cohort shifts on period fertility measures and provides an accompanying tempo adjustment to determine the period fertility that would have occurred without postponement. Cohort-based postponement spans multiple periods and produces "fertility momentum," with implications for future fertility rates. We illustrate several methods for model estimation and apply the model to fertility in several countries. We also compare the fit of period-based and cohort-based shift models to the recent Dutch fertility surface, showing how cohort- and period-based postponement can occur simultaneously. PMID:25233957

  5. Cohort Fertility Patterns in the Nordic Countries

    DEFF Research Database (Denmark)

    Andersson, Gunnar; Rønsen, Marit; Knudsen, Lisbeth B.;

    2009-01-01

    Previous analyses of period fertility suggest that the trends of the Nordic countries are sufficiently similar to speak of a common "Nordic fertility regime". We investigate whether this assumption can be corroborated by comparing cohort fertility patterns in the Nordic countries. We study...... cumulated and completed fertility of Nordic birth cohorts based on the childbearing histories of women born in 1935 and later derived from the population registers of Denmark, Finland, Norway, and Sweden. We further explore childbearing behaviour by women's educational attainment. The results show...... remarkable similarities in postponement and recuperation between the countries. Median childbearing age is about 2-3 years higher in the 1960-64 cohort than in the 1950-54 cohort, but the younger cohort recuperates the fertility level of the older cohort at ages 30 and above. A similar pattern of...

  6. Multicenter follow-up study of ankle fracture surgery

    Institute of Scientific and Technical Information of China (English)

    XU Hai-lin; WANG Gang; WANG Guang-lin; WU Xin-bao; LIU Li-min; LI Xuan; ZHANG Dian-ying; FU Zhong-guo; WANG Tian-bing; ZHANG Pei-xun; JIANG Bao-guo; SHEN Hui-liang

    2012-01-01

    Background Few data on ankle fractures in China from large multicenter epidemiological and clinical studies are available.The aim of this research was to evaluate the epidemiological features and surgical outcomes of ankle fractures by reviewing 235 patients who underwent ankle fracture surgery at five hospitals in China.Methods This study included patients who underwent ankle fracture surgery at five Chinese hospitals from January 2000 to July 2009.Age,gender,mechanism of injury,Arbeitsgemeinschaft für Osteosynthesefragen (AO) fracture type,fracture pattern,length of hospital stay and treatment outcome were recorded.Statistical analyses were conducted using SPSS software.The American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale,visual analogue scale (VAS),and arthritis scale were used to evaluate outcome.Results Of 235 patients with ankle fractures,105 were male with an average age of 37.8 years and 130 were female with an average age of 47.3 years.The average follow-up period was 55.7 months.There were significant differences in the ratios of patients in different age groups between males and females,and in mechanisms of injury among different age groups.There were also significant differences in the length of hospital stay among different fracture types and mechanisms of injury.In healed fractures,the average AOFAS ankle-hindfoot score was 95.5,with an excellence rate of 99.6%,the average VAS score was 0.17,and the average arthritis score was 0.18.Movement of the injured ankle was significantly different to that of the uninjured ankle.There were no significant differences between AO fracture types,fracture patterns or follow-up periods and AOFAS score,but there were some significant differences between these parameters and ankle joint movements,pain VAS score and arthritis score.Conclusions Ankle fractures occur most commonly in middle-aged and young males aged 20-39 years and in elderly females aged 50-69 years.The most common mechanisms of

  7. Hemodialysis Arteriovenous Fistula Patency Revisited: Results of a Prospective, Multicenter Initiative

    OpenAIRE

    Huijbregts, Henricus J.T.; Bots, Michiel L; Wittens, Cees H.A.; Schrama, Yvonne C.; Moll, Frans L.; Blankestijn, Peter J.

    2008-01-01

    Background and objectives: Vascular access standards are predominantly based on older, single-center reports; however, the hemodialysis population has changed dramatically and primary arteriovenous fistula failure is a huge problem. This prospective, multicenter study used standardized definitions to analyze patency rates and potential risk factors that affect functional patency and late arteriovenous fistula functionality.

  8. Simplified Therapeutic Intervention Scoring System : The TISS-28 items - Results from a multicenter study

    NARCIS (Netherlands)

    Miranda, DR; deRijk, A; Schaufeli, W

    1996-01-01

    Objectives: To validate a simplified version of the Therapeutic Intervention Scoring System, the TISS-28, and to determine the association of TISS-28 with the time spent on scored and nonscored nursing activities. Design: Prospective, multicenter study. Setting: Twenty-two adult medical, surgical, a

  9. Adjunctive corticosteroid therapy for Pneumocystis carinii pneumonia in AIDS: a randomized European multicenter open label study

    DEFF Research Database (Denmark)

    Nielsen, T L; Eeftinck Schattenkerk, J K; Jensen, B N;

    1992-01-01

    Fifty-nine human immunodeficiency virus type-1-infected patients with a microscopically proven first episode of moderate to severe Pneumocystis carinii pneumonia (PCP) were enrolled into a randomized European multicenter study. The effect of adjunctive corticosteroid (CS) therapy was assessed on ...

  10. Prospective Multicenter Study of Pneumocystis jirovecii Colonization among Cystic Fibrosis Patients in France

    OpenAIRE

    Hernández-Hernández, Francisca; Fréalle, Emilie; Caneiro, Patrick; Salleron, Julia; Durand-Joly, Isabelle; Accoceberry, Isabelle; Bouchara, Jean-Philippe; Wallaert, Benoit; Dei-Cas, Eduardo; Delhaes, Laurence

    2012-01-01

    Pneumocystis carriage was detected in 12.5% of 104 cystic fibrosis (CF) patients during a prospective multicenter French study, with a prevalence of genotype 85C/248C and geographic variations. It was significantly associated with the absence of Pseudomonas aeruginosa colonization and a greater forced expiratory volume in 1 s. Results are discussed considering the natural history of CF.

  11. Who Donates Their Body to Science? An International, Multicenter, Prospective Study

    Science.gov (United States)

    Cornwall, Jon; Perry, Gary F.; Louw, Graham; Stringer, Mark D.

    2012-01-01

    The altruistic act of body donation provides a precious resource for both teaching and researching human anatomy. However, relatively little is known about individuals who donate their bodies to science (donors), and in particular whether donors in different geographical locations share similar characteristics. A multicenter prospective survey of…

  12. Optimizing the definition of intrauterine growth restriction: the multicenter prospective PORTO Study.

    LENUS (Irish Health Repository)

    Unterscheider, Julia

    2013-04-01

    The objective of the Prospective Observational Trial to Optimize Pediatric Health in Intrauterine Growth Restriction (IUGR) (PORTO Study), a national prospective observational multicenter study, was to evaluate which sonographic findings were associated with perinatal morbidity and mortality in pregnancies affected by growth restriction, originally defined as estimated fetal weight (EFW) <10th centile.

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

    Directory of Open Access Journals (Sweden)

    Montes Rafael

    2011-10-01

    Full Text Available Abstract 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 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 Conclusion This study provides an overview of key clinical parameters in patients with CKD Stages 3 and 4 where delivery or care was largely by nephrologists working in a network of hospital-based clinics of the Spanish National Healthcare System.

  14. Graduate Cohort Approach in Teacher Education

    Science.gov (United States)

    Mattson-Gearhart, Jeanine

    2012-01-01

    The use of the cohorts in teacher education has steadily increased over the last decade. Research indicates both beneficial and negative aspects to this approach, with the field undecided. This study focuses on a Midwestern university's accelerated graduate program for special educators. The program uses a mixed cohort approach to model…

  15. Cohort Crowding and Nonresident College Enrollment

    Science.gov (United States)

    Winters, John V.

    2012-01-01

    This study uses a fixed effects panel data framework to examine the effects of cohort crowding and other variables on nonresident enrollment at four-year public colleges and universities. The results suggest that larger cohorts of resident students crowd out nonresident students at flagship universities, but there is inconsistent evidence of crowd…

  16. 2011 Cohort Graduation and Dropout Rate Report

    Science.gov (United States)

    Utah State Office of Education, 2011

    2011-01-01

    To align with new federal No Child Left Behind (NCLB) regulations for graduation rate calculations, the Utah State Office of Education (USOE) is reporting a new graduation rate beginning with the 2011 graduating class (also known as the 2011 cohort). The four-year cohort rate (includes all students who started 9th grade in 2007-2008 plus…

  17. Cohort Fertility Patterns in the Nordic Countries

    DEFF Research Database (Denmark)

    Andersson, Gunnar; Rønsen, Marit; Knudsen, Lisbeth B.;

    Previous analyses of period fertility suggest that the trends of the Nordic countries are sufficiently similar to speak of a common "Nordic fertility regime". We investigate whether this assumption can be corroborated by comparing cohort fertility patterns in the Nordic countries. We study...... cumulated and completed fertility of Nordic birth cohorts based on the childbearing histories of women born in 1935 and later derived from the population registers of Denmark, Finland, Norway and Sweden. We further explore childbearing behaviour by women’s educational attainment. The results show remarkable...... similarities in postponement and recuperation between the countries and very small differences in completed fertility across educational groups. Median childbearing age is about 2-3 years higher in the 1960-64-cohort than in the 1950-54-cohort, but the younger cohort recuperates the fertility level of the...

  18. Pooling birth cohorts in allergy and asthma

    DEFF Research Database (Denmark)

    Bousquet, Jean; Anto, Josep; Sunyer, Jordi;

    2013-01-01

    Long-term birth cohort studies are essential to understanding the life course and childhood predictors of allergy and the complex interplay between genes and the environment (including lifestyle and socioeconomic determinants). Over 100 cohorts focusing on asthma and allergy have been initiated in...... the world over the past 30 years. Since 2004, several research initiatives funded under the EU Framework Program for Research and Technological Development FP6-FP7 have attempted to identify, compare, and evaluate pooling data from existing European birth cohorts (GA(2)LEN: Global Allergy and European...... Network, FP6; ENRIECO: Environmental Health Risks in European Birth Cohorts, FP7; CHICOS: Developing a Child Cohort Research Strategy for Europe, FP7; MeDALL: Mechanisms of the Development of ALLergy, FP7). However, there is a general lack of knowledge about these initiatives and their potentials. The aim...

  19. MRI, PET/CT and ultrasound in the preoperative staging of endometrial cancer - a multicenter prospective comparative study

    DEFF Research Database (Denmark)

    Antonsen, Sofie Leisby; Jensen, Lisa Neerup; Tabor, Ann;

    The aim of this prospective multicenter study was to evaluate and compare the diagnostic performance of PET/CT, MRI and transvaginal two-dimensional ultrasound (2DUS) in the preoperative assessment of endometrial cancer (EC)....

  20. An open multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and mixed urinary incontinence

    DEFF Research Database (Denmark)

    Lose, Gunnar; Sørensen, Helle Christina; Axelsen, Susanne Maigaard;

    2010-01-01

    Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence.......Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This multicenter study was carried out to evaluate safety and efficacy of Bulkamid® for female stress and mixed urinary incontinence....

  1. Cohort Learning for Graduate Students at the Dissertation Stage

    Science.gov (United States)

    Holmes, Barbara D.; Birds, Kimberly; Seay, Angela D.; Smith, Debra B.; Wilson, Kimberly N.

    2010-01-01

    Doctoral students discuss the power of collaborative cohort learning in transforming the dissertation phase of doctoral study. Innovative components of doctoral cohort learning and dissertation preparation are detailed.

  2. Generational cohorts and their attitudes toward advertising

    Directory of Open Access Journals (Sweden)

    Ernest Cyril de Run

    2013-12-01

    Full Text Available This research is aimed at determining the attitudes with regard to advertising from the perspective of generational cohorts in Sarawak. A two-phase of study was conducted to firstly identify generational cohorts in the state and, secondly, to investigate the attitude of each cohort to advertising. Utilizing theories of generations, a qualitative approach by means of personal interviews was used at the outset to identify external events which bring about the formation of cohorts. Accordingly, 48 interviews were conducted and data were content-analyzed. The findings were then incorporated into the second phase of study to investigate cohorts’ views about advertising, using theory of reasoned action. A quantitative approach via questionnaire-based survey was administered, and 1,410 copies were collected for analysis. Five distinct cohorts are proposed in the initial findings. They are labeled as Neoteric Inheritors, Prospective Pursuers, Social Strivers, Idealistic Strugglers and Battling Lifers on the basis of their respective engagement with events during the coming-of-age years. The subsequent findings show that beliefs about advertising are significant predictors of the attitudes to advertising, and so are the attitudes with regard to the intention of every cohort. However, their beliefs and attitudes to advertising are found to differ significantly, especially in the older cohort. The study thus highlights the implication of generational differences on the attitudes to advertising.

  3. Cohort Fertility Patterns in the Nordic Countries

    Directory of Open Access Journals (Sweden)

    Gunnar Andersson

    2009-04-01

    Full Text Available Previous analyses of period fertility suggest that the trends of the Nordic countries are sufficiently similar to speak of a common "Nordic fertility regime". We investigate whether this assumption can be corroborated by comparing cohort fertility patterns in the Nordic countries. We study cumulated and completed fertility of Nordic birth cohorts based on the childbearing histories of women born in 1935 and later derived from the population registers of Denmark, Finland, Norway, and Sweden. We further explore childbearing behaviour by women's educational attainment. The results show remarkable similarities in postponement and recuperation between the countries and very small differences in completed fertility across educational groups. Median childbearing age is about 2-3 years higher in the 1960-64 cohort than in the 1950-54 cohort, but the younger cohort recuperates the fertility level of the older cohort at ages 30 and above. A similar pattern of recuperation can be observed for highly educated women as compared to women with less education. An interesting finding is that of a positive relationship between educational level and the final number of children when women who become mothers at similar ages are compared. Country differences in fertility outcome are generally rather low. Childlessness is highest in Finland and lowest in Norway, and the educational differentials are largest in Norway. Despite such differences, the cohort analyses in many ways support the notion of a common Nordic fertility regime.

  4. Changing mortality and average cohort life expectancy

    DEFF Research Database (Denmark)

    Schoen, Robert; Canudas-Romo, Vladimir

    2005-01-01

    Period life expectancy varies with changes in mortality, and should not be confused with the life expectancy of those alive during that period. Given past and likely future mortality changes, a recent debate has arisen on the usefulness of the period life expectancy as the leading measure of......, the average cohort life expectancy (ACLE), to provide a precise measure of the average length of life of cohorts alive at a given time. To compare the performance of ACLE with CAL and with period and cohort life expectancy, we first use population models with changing mortality. Then the four...

  5. A multicenter study confirms CD226 gene association with systemic sclerosis-related pulmonary fibrosis

    OpenAIRE

    Bossini-Castillo, L.; Simeon, C. P.; Beretta, L; Broen, J.C.A.; Vonk, M.C.; Rios-Fernandez, R.; Espinosa, G.; Carreira, P; Camps, M T; Castillo, M.J.; Gonzalez-Gay, M A; Beltran, E.; Carmen Freire, M.; Narvaez, J; Tolosa, C

    2012-01-01

    Abstract Introduction CD226 genetic variants have been associated with a number of autoimmune diseases and recently with systemic sclerosis (SSc). The aim of this study was to test the influence of CD226 loci in SSc susceptibility, clinical phenotypes and autoantibody status in a large multicenter European population. Methods A total of seven European populations of Caucasian ancestry were included, comprising 2,131 patients with SSc and 3,966 healthy controls. Three CD226 single nucleotide p...

  6. A multi-center comparison of diagnostic methods for the biochemical evaluation of suspected mitochondrial disorders

    OpenAIRE

    Rodenburg, R.J.T.; Schoonderwoerd, G.C.; Tiranti, V.; Taylor, R. W.; Rötig, A; Valente, L.; Invernizzi, F.; CHRETIEN, D.; He, L.; Backx, G.P.B.M.; Janssen, K.J.G.M.; Chinnery, P. F.; Smeets, H.J.; De Coo, I F; L. P. van den Heuvel

    2013-01-01

    A multicenter comparison of mitochondrial respiratory chain and complex V enzyme activity tests was performed. The average reproducibility of the enzyme assays is 16% in human muscle samples. In a blinded diagnostic accuracy test in patient fibroblasts and SURF1 knock-out mouse muscle, each lab made the correct diagnosis except for two complex I results. We recommend that enzyme activities be evaluated based on ratios, e.g. with complex IV or citrate synthase activity. In spite of large varia...

  7. Clinical and functional outcomes of the PCCP study : a multi-center prospective study in Italy

    OpenAIRE

    Antonini, G.; Giancola, R.; D. Berruti; E. Blanchietti; Pecchia, P.; Francione, V.; Greco, P.; T.C. Russo; L. Pietrogrande

    2013-01-01

    The standard surgical management of hip fractures is associated with tissue trauma and bleeding which are added to the fracture injury. The percutaneous compression plate (PCCP) is a minimally invasive device that has been demonstrated in previous studies to reduce postoperative complications and blood loss. This prospective, multi-center, observational study assessed clinical and functional outcomes with PCCP as treatment for trochanteric fractures. Patients with a stable or unstable proxima...

  8. Maternal near miss and death among women with severe hypertensive disorders: a Brazilian multicenter surveillance study

    OpenAIRE

    Zanette, Elvira; Parpinelli, Mary Angela; Surita, Fernanda Garanhani; Costa, Maria Laura; Haddad, Samira Maerrawi; de Sousa, Maria Helena; e Silva, Joao Luiz Pinto; Souza, Joao Paulo; Cecatti, Jose Guilherme

    2014-01-01

    Background Hypertensive disorders represent the major cause of maternal morbidity in middle income countries. The main objective of this study was to identify the prevalence and factors associated with severe maternal outcomes in women with severe hypertensive disorders. Methods This was a cross-sectional, multicenter study, including 6706 women with severe hypertensive disorder from 27 maternity hospitals in Brazil. A prospective surveillance of severe maternal morbidity with data collected ...

  9. Prevalence of iron deficiency on ICU discharge and its relation with fatigue: a multicenter prospective study

    OpenAIRE

    Lasocki, Sigismond; Chudeau, Nicolas; Papet, Thibaut; Tartiere, Deborah; Roquilly, Antoine; Carlier, Laurence; Mimoz, Olivier; Seguin, Philippe; Malledant, Yannick; Asehnoune, Karim; Hamel, Jean François; ,

    2014-01-01

    Introduction Prevalence of iron deficiency (ID) at intensive care (ICU) admission is around 25 to 40%. Blood losses are important during ICU stay, leading to iron losses, but prevalence of ID at ICU discharge is unknown. ID has been associated with fatigue and muscular weakness, and may thus impair post-ICU rehabilitation. This study assessed ID prevalence at ICU discharge, day 28 (D28) and six months (M6) after and its relation with fatigue. Methods We conducted this prospective, multicenter...

  10. Dose to patients and professionals in cardiology interventional: Progress of multicenter group Doccaci

    International Nuclear Information System (INIS)

    The multidisciplinary group and multicenter DOCCACI (dosimetry and quality assurance in interventional cardiology), sponsored by the section of haemodynamics of the Spanish society of Cardiology, is intended to propose reference levels to doses received by patients in interventional cardiology procedures such as recommended by the International Commission on radiological protection It also investigates the doses received by professionals, in particular dose in Crystallyne whose recommended limit dose has been reduced recently from 150 to 20 mSv/year. (Author)

  11. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial

    OpenAIRE

    Usman Anju; Logerquist Sally; Schneider Cindy; Smith Scott; Rossignol Lanier W; Rossignol Daniel A; Neubrander Jim; Madren Eric M; Hintz Gregg; Grushkin Barry; Mumper Elizabeth A

    2009-01-01

    Abstract Background Several uncontrolled studies of hyperbaric treatment in children with autism have reported clinical improvements; however, this treatment has not been evaluated to date with a controlled study. We performed a multicenter, randomized, double-blind, controlled trial to assess the efficacy of hyperbaric treatment in children with autism. Methods 62 children with autism recruited from 6 centers, ages 2–7 years (mean 4.92 ± 1.21), were randomly assigned to 40 hourly treatments ...

  12. THE RATE OF METABOLIC SYNDROME AND COMORBIDITIES IN PATIENTS WITH GOUT: DATA OF A MULTICENTER TRIAL

    OpenAIRE

    V G Barskova; Maksim Sergeyevich Eliseyev; I S Denisov; M E Eliseyeva; O A Belikov; G R Fadiyenko; F S Zharskaya; O P Polkovnikova; A. N. Kalyagin; M V Sklyanova; E A Shvetsova; L A Knyazeva; I M Marusenko; S E Myasoedova; E A Kozhevnikova

    2012-01-01

    Objective: to study the rate of metabolic syndrome (MS) and its components among gout patients in different regions of the Russian Federation. Subjects and methods. This cross-sectional multicenter study enrolled 2277 gout patients, including 1963 (86.2%) men and 314 (13.8%) women, from 12 independent medical centers in different regions of the Russian Federation. The patients over 18 years of age who met the classification criteria for gout, elaborated by S. Wallace et al., were included. Th...

  13. Epidemiology of acute kidney injury in Hungarian intensive care units: a multicenter, prospective, observational study

    OpenAIRE

    Bencsik Gabor; Marjanek Zsuzsanna; Gartner Bela; Kocsi Szilvia; Paloczi Balazs; Antek Csaba (1967-) (aneszteziológus); Medve Laszlo; Kanizsai Peter; Gondos Tibor

    2011-01-01

    Abstract Background Despite the substantial progress in the quality of critical care, the incidence and mortality of acute kidney injury (AKI) continues to rise during hospital admissions. We conducted a national, multicenter, prospective, epidemiological survey to evaluate the importance of AKI in intensive care units (ICUs) in Hungary. The objectives of this study were to determine the incidence of AKI in ICU patients; to characterize the differences in aetiology, illness severity and clini...

  14. Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B

    OpenAIRE

    Reinaldo de Menezes Martins; Gilberta Bensabath; Luiz Claudio Arraes; Maria de Lourdes Aguiar Oliveira; Juliana Custódio Miguel; Glayse Glayde Barbosa; Luiz Antonio Bastos Camacho

    2004-01-01

    The immunogenicity and safety of a new recombinant hepatitis B vaccine from the Instituto Butantan (Butang®) were evaluated in a multicenter, double-blind, prospective equivalence study in three centers in Brazil. Engerix B® was the standard vaccine. A total of 3937 subjects were recruited and 2754 (70%) met all protocol criteria at the end of the study. All the subjects were considered healthy and denied having received hepatitis B vaccine before the study. Study subjects who adhered to the ...

  15. Diagnosis of Tetanus Immunization Status: Multicenter Assessment of a Rapid Biological Test

    OpenAIRE

    Colombet, Isabelle; Saguez, Colette; Sanson-le Pors, Marie-José; Coudert, Benoît; Chatellier, Gilles; Espinoza, Pierre

    2005-01-01

    Diagnosis of tetanus immunization status by medical interview of patients with wounds is poor. Many protected patients receive unnecessary vaccine or immunoglobulin, and unprotected patients may receive nothing. The aim of this study is to evaluate the feasibility and accuracy of the Tetanos Quick Stick (TQS) rapid finger prick stick test in the emergency department for determining immunization status. We designed a prospective multicenter study for blinded comparison of TQS with an enzyme-li...

  16. Blastic plasmacytoid dendritic cell neoplasm with leukemic presentation: an Italian multicenter study

    OpenAIRE

    Pagano, Livio; Valentini, Caterina Giovanna; Pulsoni, Alessandro; Fisogni, Simona; Carluccio, Paola; Mannelli, Francesco; Lunghi, Monia; Pica, Gianmatteo; Onida, Francesco; Cattaneo, Chiara; Piccaluga, Pier Paolo; Di Bona, Eros; Todisco, Elisabetta; Musto, Pellegrino; Spadea, Antonio

    2013-01-01

    The objective of this study was to evaluate the clinical features, prognostic factors, and efficacy of treatments in patients with blastic plasmacytoid dendritic cell neoplasm with a leukemic presentation at onset of the disease. In order to do this, a retrospective multicenter study was performed from 2005-2011 in 28 Italian hematology divisions in which 43 cases were collected. Forty-one patients received an induction therapy, consisting of an acute myeloid leukemia-type regimen in 26 patie...

  17. Survival Nomogram for Curatively Resected Korean Gastric Cancer Patients: Multicenter Retrospective Analysis with External Validation

    OpenAIRE

    Bang Wool Eom; Keun Won Ryu; Byung-Ho Nam; Yunjin Park; Hyuk-Joon Lee; Min Chan Kim; Gyu Seok Cho; Chan Young Kim; Seung Wan Ryu; Dong Woo Shin; Woo Jin Hyung; Jun Ho Lee

    2015-01-01

    Background A small number of nomograms have been previously developed to predict the individual survival of patients who undergo curative resection for gastric cancer. However, all were derived from single high-volume centers. The aim of this study was to develop and validate a nomogram for gastric cancer patients using a multicenter database. Methods We reviewed the clinicopathological and survival data of 2012 patients who underwent curative resection for gastric cancer between 2001 and 200...

  18. Multicenter airborne coherent atmospheric wind sensor (MACAWS) instrument: recent upgrades and results

    Science.gov (United States)

    Howell, James N.; Rothermel, Jeffrey; Tratt, David M.; Cutten, Dean; Darby, Lisa S.; Hardesty, R. Michael

    1999-10-01

    The Multicenter Airborne Coherent Atmospheric Wind Sensor instrument is an airborne coherent Doppler laser radar (Lidar) capable of measuring atmospheric wind fields and aerosol structure. Since the first demonstration flights onboard the NASA DC-8 research aircraft in September 1995, two additional science flights have been completed. Several system upgrades have also bee implemented. In this paper we discuss the system upgrades and present several case studies which demonstrate the various capabilities of the system.

  19. Multicenter Study of Brain Volume Abnormalities in Children and Adolescent-Onset Psychosis

    OpenAIRE

    Reig, S. (Santiago); Parellada, M.; Castro-Fornieles, J.; Janssen, J.; Moreno, D.; Baeza, I.; Bargallo, N.; Gonzalez-Pinto, A.; Graell, M. (Montserrat); Ortuño-Sánchez-Pedreño, F. (Felipe); Otero, S.; C. Arango; Desco, M

    2010-01-01

    The goal of the study is to determine the extent of structural brain abnormalities in a multicenter sample of children and adolescents with a recent-onset first episode of psychosis (FEP), compared with a sample of healthy controls. Total brain and lobar volumes and those of gray matter (GM), white matter, and cerebrospinal fluid (CSF) were measured in 92 patients with a FEP and in 94 controls, matched for age, gender, and years of education. Male patients (n = 64) showed several significant ...

  20. Multistate cohort models with proportional transfer rates

    DEFF Research Database (Denmark)

    Schoen, Robert; Canudas-Romo, Vladimir

    2006-01-01

    We present a new, broadly applicable approach to summarizing the behavior of a cohort as it moves through a variety of statuses (or states). The approach is based on the assumption that all rates of transfer maintain a constant ratio to one another over age. We present closed-form expressions for...... the size and state composition of the cohort at every age and provide expressions for other useful summary measures. The state trajectories, or life course schematics, depict all the possible size and state configurations that the cohort can exhibit over its life course under the specified pattern of.......61. Increases in parity progression rates to parities 4 and above have little effect on a cohort's TFR, while changes in childlessness have a substantial impact....

  1. Does Quality of Radiation Therapy Predict Outcomes of Multicenter Cooperative Group Trials? A Literature Review

    International Nuclear Information System (INIS)

    Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question

  2. Expanding the Use of Time-Based Metering: Multi-Center Traffic Management Advisor

    Science.gov (United States)

    Landry, Steven J.; Farley, Todd; Hoang, Ty

    2005-01-01

    Time-based metering is an efficient air traffic management alternative to the more common practice of distance-based metering (or "miles-in-trail spacing"). Despite having demonstrated significant operational benefit to airspace users and service providers, time-based metering is used in the United States for arrivals to just nine airports and is not used at all for non-arrival traffic flows. The Multi-Center Traffic Management Advisor promises to bring time-based metering into the mainstream of air traffic management techniques. Not constrained to operate solely on arrival traffic, Multi-Center Traffic Management Advisor is flexible enough to work in highly congested or heavily partitioned airspace for any and all traffic flows in a region. This broader and more general application of time-based metering is expected to bring the operational benefits of time-based metering to a much wider pool of beneficiaries than is possible with existing technology. It also promises to facilitate more collaborative traffic management on a regional basis. This paper focuses on the operational concept of the Multi-Center Traffic Management Advisor, touching also on its system architecture, field test results, and prospects for near-term deployment to the United States National Airspace System.

  3. Validation of the pooled cohort risk score in an Asian population – a retrospective cohort study

    OpenAIRE

    Chia, Yook Chin; Lim, Hooi Min; Ching, Siew Mooi

    2014-01-01

    Background The Pooled Cohort Risk Equation was introduced by the American College of Cardiology (ACC) and American Heart Association (AHA) 2013 in their Blood Cholesterol Guideline to estimate the 10-year atherosclerotic cardiovascular disease (ASCVD) risk. However, absence of Asian ethnicity in the contemporary cohorts and limited studies to examine the use of the risk score limit the applicability of the equation in an Asian population. This study examines the validity of the pooled cohort ...

  4. European birth cohorts for environmental health research

    DEFF Research Database (Denmark)

    Vrijheid, Martine; Casas, Maribel; Bergström, Anna;

    2012-01-01

    Many pregnancy and birth cohort studies investigate the health effects of early-life environmental contaminant exposure. An overview of existing studies and their data is needed to improve collaboration, harmonization, and future project planning.......Many pregnancy and birth cohort studies investigate the health effects of early-life environmental contaminant exposure. An overview of existing studies and their data is needed to improve collaboration, harmonization, and future project planning....

  5. High mortality in the Thule cohort

    DEFF Research Database (Denmark)

    Juel, K

    1994-01-01

    The objective was to study mortality in the Thule cohort in order to clarify whether it is a selected population and to ascertain the possibility of misinterpretation when national mortality rates are used as reference in the analysis of occupational mortality.......The objective was to study mortality in the Thule cohort in order to clarify whether it is a selected population and to ascertain the possibility of misinterpretation when national mortality rates are used as reference in the analysis of occupational mortality....

  6. Clinical Spectrum Time Course in Anti Jo-1 Positive Antisynthetase Syndrome: Results From an International Retrospective Multicenter Study.

    Science.gov (United States)

    Cavagna, Lorenzo; Nuño, Laura; Scirè, Carlo Alberto; Govoni, Marcello; Longo, Francisco Javier Lopez; Franceschini, Franco; Neri, Rossella; Castañeda, Santos; Sifuentes Giraldo, Walter Alberto; Caporali, Roberto; Iannone, Florenzo; Fusaro, Enrico; Paolazzi, Giuseppe; Pellerito, Raffaele; Schwarting, Andreas; Saketkoo, Lesley Ann; Ortego-Centeno, Norberto; Quartuccio, Luca; Bartoloni, Elena; Specker, Christof; Murcia, Trinitario Pina; La Corte, Renato; Furini, Federica; Foschi, Valentina; Corral, Javier Bachiller; Airò, Paolo; Cavazzana, Ilaria; Martínez-Barrio, Julia; Hinojosa, Michelle; Giannini, Margherita; Barsotti, Simone; Menke, Julia; Triantafyllias, Kostantinos; Vitetta, Rosetta; Russo, Alessandra; Bajocchi, Gianluigi; Bravi, Elena; Barausse, Giovanni; Bortolotti, Roberto; Selmi, Carlo; Parisi, Simone; Montecucco, Carlomaurizio; González-Gay, Miguel Angel

    2015-08-01

    Anti Jo-1 antibodies are the main markers of the antisynthetase syndrome (ASSD), an autoimmune disease clinically characterized by the occurrence of arthritis, myositis, and interstitial lung disease (ILD). These manifestations usually co-occur (for practical purpose complete forms) in the same patient, but cases with only 1 or 2 of these findings (for practical purpose incomplete forms) have been described. In incomplete forms, the ex novo occurrence of further manifestations is possible, although with frequencies and timing not still defined. The aim of this international, multicenter, retrospective study was to characterize the clinical time course of anti Jo-1 positive ASSD in a large cohort of patients. Included patients should be anti Jo-1 positive and with at least 1 feature between arthritis, myositis, and ILD. We evaluated the differences between complete and incomplete forms, timing of clinical picture appearance and analyzed factors predicting the appearance of further manifestations in incomplete ASSD. Finally, we collected 225 patients (58 males and 167 females) with a median follow-up of 80 months. At the onset, complete ASSD were 44 and incomplete 181. Patients with incomplete ASSD had frequently only 1 of the classic triad findings (110 cases), in particular, isolated arthritis in 54 cases, isolated myositis in 28 cases, and isolated ILD in 28 cases. At the end of follow-up, complete ASSD were 113, incomplete 112. Only 5 patients had an isolated arthritis, only 5 an isolated myositis, and 15 an isolated ILD. During the follow-up, 108 patients with incomplete forms developed further manifestations. Single main feature onset was the main risk factor for the ex novo appearance of further manifestation. ILD was the prevalent ex novo manifestation (74 cases). In conclusion, ASSD is a condition that should be carefully considered in all patients presenting with arthritis, myositis, and ILD, even when isolated. The ex novo appearance of further

  7. Effect of in-painting on cortical thickness measurements in multiple sclerosis: A large cohort study.

    Science.gov (United States)

    Govindarajan, Koushik A; Datta, Sushmita; Hasan, Khader M; Choi, Sangbum; Rahbar, Mohammad H; Cofield, Stacey S; Cutter, Gary R; Lublin, Fred D; Wolinsky, Jerry S; Narayana, Ponnada A

    2015-10-01

    A comprehensive analysis of the effect of lesion in-painting on the estimation of cortical thickness using magnetic resonance imaging was performed on a large cohort of 918 relapsing-remitting multiple sclerosis patients who participated in a phase III multicenter clinical trial. An automatic lesion in-painting algorithm was developed and implemented. Cortical thickness was measured using the FreeSurfer pipeline with and without in-painting. The effect of in-painting was evaluated using FreeSurfer's paired analysis pipeline. Multivariate regression analysis was also performed with field strength and lesion load as additional factors. Overall, the estimated cortical thickness was different with in-painting than without. The effect of in-painting was observed to be region dependent, more significant in the left hemisphere compared to the right, was more prominent at 1.5 T relative to 3 T, and was greater at higher lesion volumes. Our results show that even for data acquired at 1.5 T in patients with high lesion load, the mean cortical thickness difference with and without in-painting is ∼2%. Based on these results, it appears that in-painting has only a small effect on the estimated regional and global cortical thickness. Hum Brain Mapp 36:3749-3760, 2015. © 2015 Wiley Periodicals, Inc. PMID:26096844

  8. Opportunistic illnesses in Brazilian children with AIDS: results from two national cohort studies, 1983-2007

    Directory of Open Access Journals (Sweden)

    Heukelbach Jorg

    2011-07-01

    Full Text Available Abstract Background HAART has significantly reduced AIDS-related morbidity in children. However, limited evidence is available from developing countries regarding patterns of opportunistic illnesses. We describe these events and their associated factors in children with AIDS in Brazil. Methods This study is based on two representative retrospective multi-center cohorts including a total 1,859 children with AIDS, infected via mother-to-child transmission (MTCT, between 1983-2002. Opportunistic illnesses were described and analyzed over time. The association of demographic, clinical and operational data with the occurrence of opportunistic diseases was assessed. Results In total, 1,218 (65.5% had at least one event of an opportunistic disease. Variables significantly associated with occurrence of these events included: region of residence (OR 2.68-11.33, as compared to the Northern region, age Pneumocystis jirovecii pneumonia (21.9 vs. 13.2%; p Conclusions Despite the significant reduction in recent years, opportunistic illnesses are still common in Brazilian children with AIDS in the HAART era, especially bacterial diseases. The data reinforce the need for scaling up prevention of MTCT, early diagnosis of infection, and improvement of comprehensive pediatric care.

  9. Micronutrient levels and supplement intake in pregnancy after bariatric surgery: a prospective cohort study.

    Directory of Open Access Journals (Sweden)

    Roland Devlieger

    Full Text Available Studies report frequent micronutrient deficiencies after bariatric surgery, but less is known about micronutrient levels of pregnant women after bariatric surgery.To prospectively evaluate micronutrient levels and supplement intake in pregnancy following bariatric surgery.A multicenter prospective cohort study including women with restrictive or malabsorptive types of bariatric surgery. Nutritional deficiencies, together with supplement intake, were screened during pregnancy.The total population included 18 women in the restrictive and 31 in the malabsorptive group. Most micronutrients were depleted and declined significantly during pregnancy. The proportion of women with low vitamin A and B-1 levels increased to respectively 58 and 17% at delivery (P = 0.005 and 0.002. The proportion of women with vitamin D deficiency decreased from 14% at trimester 1 to 6% at delivery (P = 0.030. Mild anemia was found in respectively 22 and 40% of the women at trimester 1 and delivery. In the first trimester, most women took a multivitamin (57.1%. In the second and third trimester, the majority took additional supplements (69.4 and 73.5%. No associations were found between supplement intake and micronutrient deficiencies.Pregnant women with bariatric surgery show frequent low micronutrient levels. Supplementation partially normalizes low levels of micronutrients.

  10. Racial/Ethnic Patterns in Prostate Cancer Outcomes in an Active Surveillance Cohort

    Directory of Open Access Journals (Sweden)

    Jennifer Cullen

    2011-01-01

    Full Text Available Introduction. Concern regarding overtreatment of prostate cancer (CaP is leading to increased attention on active surveillance (AS. This study examined CaP survivors on AS and compared secondary treatment patterns and overall survival by race/ethnicity. Methods. The study population consisted of CaP patients self-classified as black or white followed on AS in the Center for Prostate Disease Research (CPDR multicenter national database between 1989 and 2008. Secondary treatment included radical prostatectomy (RP, external beam radiation therapy or brachytherapy (EBRT-Br, and hormone therapy (HT. Secondary treatment patterns and overall survival were compared by race/ethnicity. Results. Among 886 eligible patients, 21% were black. Despite racial differences in risk characteristics and secondary treatment patterns, overall survival was comparable across race. RP following AS was associated with the longest overall survival. Conclusion. Racial disparity in overall survival was not observed in this military health care beneficiary cohort with an equal access to health care.

  11. Epidemiological composition, clinical and treatment characteristics of the patient cohort of the german competence network for HIV/AIDS

    Directory of Open Access Journals (Sweden)

    Jansen K

    2009-09-01

    Full Text Available Abstract Objective As its central basis for research, the Competence Network for HIV/AIDS (KompNet established a nationwide cohort study on HIV-positive patients being in medical care in Germany. In this paper, we describe the epidemiological composition, and clinical as well as treatment characteristics of the KompNet cohort over time. Methods The KompNet cohort is an open, retrospective and prospective, multi-center, disease-specific and nationwide cohort study that started gathering data in June 2004. Semiannually, follow up visits of the patients are documented, covering a wide range of clinical and sociodemographic data. At enrolment and three years afterwards, an EDTA-sample is taken; a serum-sample is taken at every follow up. Results As of 20.10.2008, a total of 15,541 patients were enrolled by 44 documenting sites. In September 2007, the cohort size was reduced to ten outpatient clinics and fifteen private practitioners, covering a total of 9,410 patients. The documentation of these patients comprised 24,117 years of follow up-time since enrolment (mean: 2.6 years, 62,862 person years inclusive data documented retrospectively on course of HIV-infection and antiretroviral therapy (ART, mean: 6.7 years. Due to the short period of recruitment till now, rates of death (0.3%-0.8% and losses to follow up (1.1%-5.5% were low. 84.9% of patients were men. Main risk of transmission was sex between men (MSM: 62.9%. Mean age was 45 years. About two third of patients were classified as CDC-stage B or C. Therapy regimens of currently treated patients complied with recent guidelines. Trends of mean CD4 cell count/μl regarding the initial therapy and concerning the population under treatment reflected the developments and the changing standards of antiretroviral therapy over time. Conclusion The KompNet cohort covers about a quarter of all patients estimated as being under treatment in Germany. Its composition can be accounted approximately

  12. Cohort Profile : LifeLines, a three-generation cohort study and biobank

    NARCIS (Netherlands)

    Scholtens, Salome; Smidt, Nynke; Swertz, Morris A.; Bakker, Stephan J. L.; Dotinga, Aafje; Vonk, Judith M.; van Dijk, Freerk; van Zon, Sander K. R.; Wijmenga, Cisca; Wolffenbuttel, Bruce H. R.; Stolk, Ronald P.

    2015-01-01

    The LifeLines Cohort Study is a large population-based cohort study and biobank that was established as a resource for research on complex interactions between environmental, phenotypic and genomic factors in the development of chronic diseases and healthy ageing. Between 2006 and 2013, inhabitants

  13. Cohort versus Non-Cohort High School Students' Math Performance: Achievement Test Scores and Coursework

    Science.gov (United States)

    Parke, Carol S.; Keener, Dana

    2011-01-01

    The purpose of this study is to compare multiple measures of mathematics achievement for 1,378 cohort students who attended the same high school in a district from 9th to 12th grade with non-cohort students in each grade level. Results show that mobility had an impact on math achievement. After accounting for gender, ethnicity, and SES, adjusted…

  14. Regulation of Viable and Optimal Cohorts

    Energy Technology Data Exchange (ETDEWEB)

    Aubin, Jean-Pierre, E-mail: aubin.jp@gmail.com [VIMADES (Viabilité, Marchés, Automatique, Décisions) (France)

    2015-10-15

    This study deals with the evolution of (scalar) attributes (resources or income in evolutionary demography or economics, position in traffic management, etc.) of a population of “mobiles” (economic agents, vehicles, etc.). The set of mobiles sharing the same attributes is regarded as an instantaneous cohort described by the number of its elements. The union of instantaneous cohorts during a mobile window between two attributes is a cohort. Given a measure defining the number of instantaneous cohorts, the accumulation of the mobile attributes on a evolving mobile window is the measure of the cohort on this temporal mobile window. Imposing accumulation constraints and departure conditions, this study is devoted to the regulation of the evolutions of the attributes which are1.viable in the sense that the accumulations constraints are satisfied at each instant;2.and, among them, optimal, in the sense that both the duration of the temporal mobile window is maximum and that the accumulation on this temporal mobile window is the largest viable one. This value is the “accumulation valuation” function. Viable and optimal evolutions under accumulation constraints are regulated by an “implicit Volterra integro-differential inclusion” built from the accumulation valuation function, solution to an Hamilton–Jacobi–Bellman partial differential equation under constraints which is constructed for this purpose.

  15. Regulation of Viable and Optimal Cohorts

    International Nuclear Information System (INIS)

    This study deals with the evolution of (scalar) attributes (resources or income in evolutionary demography or economics, position in traffic management, etc.) of a population of “mobiles” (economic agents, vehicles, etc.). The set of mobiles sharing the same attributes is regarded as an instantaneous cohort described by the number of its elements. The union of instantaneous cohorts during a mobile window between two attributes is a cohort. Given a measure defining the number of instantaneous cohorts, the accumulation of the mobile attributes on a evolving mobile window is the measure of the cohort on this temporal mobile window. Imposing accumulation constraints and departure conditions, this study is devoted to the regulation of the evolutions of the attributes which are1.viable in the sense that the accumulations constraints are satisfied at each instant;2.and, among them, optimal, in the sense that both the duration of the temporal mobile window is maximum and that the accumulation on this temporal mobile window is the largest viable one. This value is the “accumulation valuation” function. Viable and optimal evolutions under accumulation constraints are regulated by an “implicit Volterra integro-differential inclusion” built from the accumulation valuation function, solution to an Hamilton–Jacobi–Bellman partial differential equation under constraints which is constructed for this purpose

  16. Review of Cohort Studies for Mood Disorders.

    Science.gov (United States)

    Jeon, Hong Jin; Baek, Ji Hyun; Ahn, Yong-Min; Kim, Se Joo; Ha, Tae Hyun; Cha, Boseok; Moon, Eunsoo; Kang, Hee-Ju; Ryu, Vin; Cho, Chul-Hyun; Heo, Jung-Yoon; Kim, Kiwon; Lee, Heon-Jeong

    2016-05-01

    This paper aimed to review currently available cohort studies of subjects with mood disorders such as major depressive disorder (MDD) and bipolar disorder (BD). Using the PubMed and KoreaMed databases, we reviewed eight major cohort studies. Most studies recruited participants with MDD and BD separately, so direct comparison of factors associated with diagnostic changes was difficult. Regular and frequent follow-up evaluations utilizing objective mood ratings and standardized evaluation methods in a naturalistic fashion are necessary to determine detailed clinical courses of mood disorders. Further, biological samples should also be collected to incorporate clinical findings in the development of new diagnostic and therapeutic approaches. An innovative cohort study that can serve as a platform for translational research for treatment and prevention of mood disorders is critical in determining clinical, psychosocial, neurobiological and genetic factors associated with long-term courses and consequences of mood disorders in Korean patients. PMID:27247592

  17. Environmental exposure assessment in European birth cohorts

    DEFF Research Database (Denmark)

    Gehring, Ulrike; Casas, Maribel; Brunekreef, Bert;

    2013-01-01

    hand tobacco smoke (SHS), persistent organic pollutants (POPs), noise, radiation, and occupational exposures. The review lists methods and data on environmental exposures in 37 European birth cohort studies. Most data is currently available for smoking and SHS (N=37 cohorts), occupational exposures (N...... of the environmental exposure and health data in these studies was made as part of the ENRIECO (Environmental Health Risks in European Birth Cohorts) project. The focus with regard to exposure was on outdoor air pollution, water contamination, allergens and biological organisms, metals, pesticides, smoking and second......=33), outdoor air pollution, and allergens and microbial agents (N=27). Exposure modeling is increasingly used for long-term air pollution exposure assessment; biomonitoring is used for assessment of exposure to metals, POPs and other chemicals; and environmental monitoring for house dust mite...

  18. The new pooled cohort equations risk calculator

    DEFF Research Database (Denmark)

    Preiss, David; Kristensen, Søren L

    2015-01-01

    total cardiovascular risk score. During development of joint guidelines released in 2013 by the American College of Cardiology (ACC) and American Heart Association (AHA), the decision was taken to develop a new risk score. This resulted in the ACC/AHA Pooled Cohort Equations Risk Calculator. This risk...... calculator, based on major National Heart, Lung, and Blood Institute-funded cohort studies, is designed to predict 10-year risk of 'hard' atherosclerotic cardiovascular disease (ASCVD) events, namely, nonfatal myocardial infarction, fatal coronary heart disease, nonfatal, or fatal stroke. Considerable...... disease and any measure of social deprivation. An early criticism of the Pooled Cohort Equations Risk Calculator has been its alleged overestimation of ASCVD risk which, if confirmed in the general population, is likely to result in statin therapy being prescribed to many individuals at lower risk than...

  19. The Danish National Cohort Study (DANCOS)

    DEFF Research Database (Denmark)

    Davidsen, Michael; Kjøller, Mette; Helweg-Larsen, Karin

    2011-01-01

    INTRODUCTION: The Danish National Cohort Study (DANCOS) is a nationally representative public health survey based on linkage of information in the repeated Danish Health Interview surveys, 1986-2005, to the national Danish registers on health and welfare. It facilitates studies of self-reported h......INTRODUCTION: The Danish National Cohort Study (DANCOS) is a nationally representative public health survey based on linkage of information in the repeated Danish Health Interview surveys, 1986-2005, to the national Danish registers on health and welfare. It facilitates studies of self...

  20. A cohort of novice Danish science teachers

    DEFF Research Database (Denmark)

    Nielsen, Birgitte Lund

    2011-01-01

    A survey on science background and argumentation about science teaching was conducted on a local cohort of newly qualified Danish science teachers. The survey was administered before the novice teachers began their first jobs in primary and lower secondary schools and focused on their reflections...... on students' activities as a goal in themselves, few considered what the students learned through the activities. Results furthermore suggest that the teachers' own assessment of their subject matter knowledge in the physics field may, for a large subgroup in the cohort, affect their approach to...

  1. Quantitative analysis of stress thallium-201 myocardial scintigrams: a multicenter trial

    International Nuclear Information System (INIS)

    Previously we validated a method for quantification of 201TI myocardial stress distribution and washout in which the patient's stress and washout circumferential profiles are compared with observed normal limits. The present study reports the results of a multicenter trial in which this method, utilizing normal limits from our institution, was employed to evaluate the presence, location, and extent of coronary artery disease (CAD). The normal limits utilized were generated from 49 patients having a low likelihood of CAD. The study population included 157 patients from four centers in the United States and Canada as well as a comparative prospective population from Cedars-Sinai Medical Center (CSMC) of 51 patients with CAD, 30 patients with normal coronary arteriograms, and 30 additional low-likelihood normals. The results in the combined centers regarding overall detection of CAD revealed a sensitivity of 84% and a frequency of test normality in the patients with low likelihood of CAD of 88%, compared to a sensitivity of 82% and true normalcy rate of 83% obtained in the prospective CSMC population. The sensitivity for detecting disease increased according to the extent of angiographic CAD in both the multicenter sites and the prospective CSMC group. Regarding localization of disease, similar sensitivities and specificities for detecting disease in individual coronary arteries were found in the multicenter sites and the prospective CSMC population. The results indicate that our method for quantifying 201TI stress-redistribution scintigrams utilizing standard normal limits can be applied at other institutions using a variety of scintillation cameras with similar accuracy to that currently obtained at our institution

  2. Mass Spectrometry Imaging of Biological Tissue: An Approach for Multicenter Studies

    Energy Technology Data Exchange (ETDEWEB)

    Rompp, Andreas; Both, Jean-Pierre; Brunelle, Alain; Heeren, Ronald M.; Laprevote, Olivier; Prideaux, Brendan; Seyer, Alexandre; Spengler, Bernhard; Stoeckli, Markus; Smith, Donald F.

    2015-03-01

    Mass spectrometry imaging has become a popular tool for probing the chemical complexity of biological surfaces. This led to the development of a wide range of instrumentation and preparation protocols. It is thus desirable to evaluate and compare the data output from different methodologies and mass spectrometers. Here, we present an approach for the comparison of mass spectrometry imaging data from different laboratories (often referred to as multicenter studies). This is exemplified by the analysis of mouse brain sections in five laboratories in Europe and the USA. The instrumentation includes matrix-assisted laser desorption/ionization (MALDI)-time-of-flight (TOF), MALDI-QTOF, MALDIFourier transform ion cyclotron resonance (FTICR), atmospheric-pressure (AP)-MALDI-Orbitrap, and cluster TOF-secondary ion mass spectrometry (SIMS). Experimental parameters such as measurement speed, imaging bin width, and mass spectrometric parameters are discussed. All datasets were converted to the standard data format imzML and displayed in a common open-source software with identical parameters for visualization, which facilitates direct comparison of MS images. The imzML conversion also allowed exchange of fully functional MS imaging datasets between the different laboratories. The experiments ranged from overview measurements of the full mouse brain to detailed analysis of smaller features (depending on spatial resolution settings), but common histological features such as the corpus callosum were visible in all measurements. High spatial resolution measurements of AP-MALDI-Orbitrap and TOF-SIMS showed comparable structures in the low-micrometer range. We discuss general considerations for planning and performing multicenter studies in mass spectrometry imaging. This includes details on the selection, distribution, and preparation of tissue samples as well as on data handling. Such multicenter studies in combination with ongoing activities for reporting guidelines, a common

  3. Extremal multicenter black holes: nilpotent orbits and Tits Satake universality classes

    Science.gov (United States)

    Fré, Pietro; Sorin, Alexander S.

    2013-01-01

    Four dimensional supergravity theories whose scalar manifold is a symmetric coset manifold UD=4/Hc are arranged into a finite list of Tits Satake universality classes. Stationary solutions of these theories, spherically symmetric or not, are identified with those of an euclidian three-dimensional σ-model, whose target manifold is a Lorentzian coset UD=3/H* and the extremal ones are associated with H* nilpotent orbits in the K* representation emerging from the orthogonal decomposition of the algebra {U} D=3 with respect to H*. It is shown that the classification of such orbits can always be reduced to the Tits-Satake projection and it is a class property of the Tits Satake universality classes. The construction procedure of Bossard et al of extremal multicenter solutions by means of a triangular hierarchy of integrable equations is completed and converted into a closed algorithm by means of a general formula that provides the transition from the symmetric to the solvable gauge. The question of the relation between H* orbits and charge orbits W of the corresponding black holes is addressed and also reduced to the corresponding question within the Tits Satake projection. It is conjectured that on the vanishing locus of the Taub-NUT current the relation between H*-orbit and W-orbit is rigid and one-to-one. All black holes emerging from multicenter solutions associated with a given H* orbit have the same W-type. For the S 3 model we provide a complete survey of its multicenter solutions associated with all of the previously classified nilpotent orbits of {s}{l}(2)× {s}{l}(2) within {{{g}}_{2,2 }} . We find a new intrinsic classification of the W-orbits of this model that might provide a paradigm for the analogous classification in all the other Tits Satake universality classes.

  4. Open, multicenter study to evaluate the tolerability and efficacy of Echinaforce Forte tablets in athletes.

    Science.gov (United States)

    Schoop, Ronald; Büechi, Samuel; Suter, Andy

    2006-01-01

    This open, multicenter study investigated the tolerability and efficacy of a new tablet formulation of Echinacea purpurea extract (Echinaforce Forte; A. Vogel, Bioforce AG, Roggwil, Switzerland) in 80 subjects actively involved in sports. Most investigators (97.5%) rated the treatment as having "very good" or "good" tolerability. About 75% of patients and investigators rated its efficacy during a common cold as "very good" or "good," and 71% of subjects were free of cold episodes. This study is the first to suggest that Echinaforce is effective in the prophylaxis, as well as the treatment, of the common cold in persons who actively participate in sports. PMID:17142219

  5. A multi-center comparison of diagnostic methods for the biochemical evaluation of suspected mitochondrial disorders.

    Science.gov (United States)

    Rodenburg, R J T; Schoonderwoerd, G C; Tiranti, V; Taylor, R W; Rötig, A; Valente, L; Invernizzi, F; Chretien, D; He, L; Backx, G P B M; Janssen, K J G M; Chinnery, P F; Smeets, H J; de Coo, I F; van den Heuvel, L P

    2013-01-01

    A multicenter comparison of mitochondrial respiratory chain and complex V enzyme activity tests was performed. The average reproducibility of the enzyme assays is 16% in human muscle samples. In a blinded diagnostic accuracy test in patient fibroblasts and SURF1 knock-out mouse muscle, each lab made the correct diagnosis except for two complex I results. We recommend that enzyme activities be evaluated based on ratios, e.g. with complex IV or citrate synthase activity. In spite of large variations in observed enzyme activities, we show that inter-laboratory comparison of patient sample test results is possible by using normalization against a control sample. PMID:23164799

  6. Multicenter evaluation of the nitrate reductase assay for drug resistance detection of Mycobacterium tuberculosis.

    Science.gov (United States)

    Martin, Anandi; Montoro, Ernesto; Lemus, Dihadenys; Simboli, Norberto; Morcillo, Nora; Velasco, Maritza; Chauca, José; Barrera, Lucía; Ritacco, Viviana; Portaels, Françoise; Palomino, Juan Carlos

    2005-11-01

    The performance of the nitrate reductase assay was evaluated in a multicenter laboratory study to detect resistance of Mycobacterium tuberculosis to the first-line anti-tuberculosis drugs rifampicin, isoniazid, ethambutol and streptomycin using a set of coded isolates. Compared with the gold standard proportion method on Löwenstein-Jensen medium, the assay was highly accurate in detecting resistance to rifampicin, isoniazid and ethambutol with an accuracy of 98%, 96.6% and 97.9%, respectively. For streptomycin, discrepant results were obtained with an overall accuracy of 85.3%. The assay proved easy to be implemented in countries with limited laboratory facilities. PMID:15893391

  7. Multicenter molecular integrals for Slater orbitals of higher principal quantum numbers

    Science.gov (United States)

    Tai, H.

    1989-01-01

    As was shown earlier by Tai (1979), by using the Fourier-transform technique and properly coupling a pair of two-center exchange integrals, the multicenter molecular integrals can be cast into a simple expression upon which numerical procedures can be directly applied. In this paper, the procedure of Tai is extended to integrals involving orbitals with arbitrarily higher principal quantum number. The derivation is outlined, and the explicit expressions are presented for a three-center nuclear attraction integral and a four-center two-electron Coulomb repulsion integral of arbitrary higher states.

  8. A Multi-center Study for Birth Defect Monitoring Systems in Korea

    OpenAIRE

    Yang, Jae-Hyug; Kim, Yon-Ju; Chung, Jin-Hoon; Kim, Moon-Young; Ryu, Hyun-Mee; Ahn, Hyun-Kyong; Han, Jung-Yul; Yang, Soon-Ha; Kim, Ahm; Kim, Hyun-Se; Lee, Pyo-Jong; Kim, Sung-Soo; Kim, Young-Ju; Koh, Kyung-Sim; Shin, Jong-Chul

    2004-01-01

    The aim of this study was to establish a multi-center birth defects monitoring system to evaluate the prevalence and the serial occurrence of birth defects in Korea. Ten medical centers participated in this program. A trained nurse collected relevant records from delivery units and pediatric clinics in participating hospitals on a monthly basis. We observed 1,537 cases of birth defects among 86,622 deliveries, which included live births and stillbirths. The prevalence of birth defects was 1.8...

  9. Cohort profile: the Spanish WORKing life Social Security (WORKss) cohort study

    Science.gov (United States)

    López Gómez, María Andrée; Durán, Xavier; Zaballa, Elena; Sanchez-Niubo, Albert; Delclos, George L; Benavides, Fernando G

    2016-01-01

    Purpose The global economy is changing the labour market and social protection systems in Europe. The effect of both changes on health needs to be monitored in view of an ageing population and the resulting increase in prevalence of chronic health conditions. The Spanish WORKing life Social Security (WORKss) cohort study provides unique longitudinal data to study the impact of labour trajectories and employment conditions on health, in terms of sickness absence, permanent disability and death. Participants The WORKss cohort originated from the Continuous Working Life Sample (CWLS) generated by the General Directorate for the Organization of the Social Security in Spain. The CWLS contains a 4% representative sample of all individuals in contact with the Social Security system. The WORKss cohort exclusively includes individuals with a labour trajectory from 1981 or later. In 2004, the cohort was initiated with 1 022 779 Social Security members: 840 770 (82.2%) contributors and 182 009 (17.8%) beneficiaries aged 16 and older. Findings to date The WORKss cohort includes demographic characteristics, chronological data about employment history, retirement, permanent disability and death. These data make possible the measurement of incidence of permanent disability, the number of potential years of working life lost, and the number of contracts and inactive periods with the Social Security system. The WORKss cohort was linked to temporary sickness absence registries to study medical diagnoses that lead to permanent disability and consequently to an earlier exit from the labour market in unhealthy conditions. Future plans Thanks to its administrative source, the WORKss cohort study will continue follow-up in the coming years, keeping the representativeness of the Spanish population affiliated to the Social Security system. The linkage between the WORKss cohort and temporary sickness absence registries is envisioned to continue. Future plans include the linkage of

  10. Brain-Science Based Cohort Studies

    Science.gov (United States)

    Koizumi, Hideaki

    2011-01-01

    This article describes a number of human cohort studies based on the concept of brain-science and education. These studies assess the potential effects of new technologies on babies, children and adolescents, and test hypotheses drawn from animal and genetic case studies to see if they apply to people. A flood of information, virtual media,…

  11. Cohort Size and the Academic Labor Market.

    Science.gov (United States)

    Stapleton, David C.

    1989-01-01

    Argues that policymakers should be skeptical of forecasts that predict faculty shortages and surpluses according to population trends and analyzes an economic model of the academic labor market. Concludes that forecasts from such models do not support policies designed to offset the impact of cohort size on the academic labor market. (Author/CH)

  12. European Birth Cohorts for Environmental Health Research

    Czech Academy of Sciences Publication Activity Database

    Vrijheid, M.; Casas, M.; Bergström, A.; Carmichael, A.; Cordier, S.; Eggesbø, M.; Eller, E.; Fantini, M. P.; Fernández, M. F.; Fernández-Somoano, A.; Gehring, U.; Grazuleviciene, R.; Hohmann, C.; Karvonen, A. M.; Keil, T.; Kogevinas, M.; Koppen, G.; Krämer, U.; Kuehni, C. E.; Magnus, P.; Majewska, R.; Andersen, A. M. N.; Patelarou, E.; Petersen, M. S.; Pierik, F. H.; Polanska, K.; Porta, D.; Richiardi, L.; Santos, A. C.; Slama, R.; Šrám, Radim; Thijs, C.; Tischer, C.; Toft, G.; Trnovec, T.; Vandentorren, S.; Vrijkotte, T. G. M.; Wilhelm, M.; Wright, J.; Nieuwenhuijsen, M.

    2012-01-01

    Roč. 120, č. 1 (2012), s. 29-37. ISSN 0091-6765 Institutional research plan: CEZ:AV0Z50390703 Keywords : environment pollution * child health * European birth cohorts Subject RIV: DN - Health Impact of the Environment Quality Impact factor: 7.260, year: 2012

  13. Familial aggregation of hypospadias: a cohort study

    DEFF Research Database (Denmark)

    Schnack, Tine H; Zdravkovic, Slobodan; Myrup, Charlotte;

    2008-01-01

    hypospadias in a cohort of 1,201,790 boys born in 1973-2005. Using binomial log-linear regression, they estimated recurrence risk ratios of hypospadias for male twin pairs and first-, second-, and third-degree relatives of a hypospadias case, which were 50.8 (95% confidence interval [CI]: 34.2, 75.5), 11...

  14. Constrictive pericarditis in a contemporary Danish cohort

    DEFF Research Database (Denmark)

    Landex, Nadia Lander; Ihlemann, Nikolaj; Olsen, Peter Skov;

    2015-01-01

    OBJECTIVES: The aetiology and outcome of constrictive pericarditis vary between geographic regions and has changed over time. We describe the diagnostic work-up and outcome in a contemporary cohort of Danish patients with constrictive pericarditis. DESIGN: Hospital databases were searched for...

  15. Knee Arthroscopy Cohort Southern Denmark (KACS)

    DEFF Research Database (Denmark)

    Thorlund, Jonas Bloch; Christensen, Robin; Nissen, Nis;

    2013-01-01

    pain, function and quality of life after meniscus surgery and factors affecting these outcomes. The aim of this prospective cohort study is to investigate the natural time course of patient-reported outcomes in patients undergoing meniscus surgery, with particular emphasis on the role of type of...

  16. Survival in HIV-infected patients after a cancer diagnosis in the cART Era: results of an italian multicenter study.

    Directory of Open Access Journals (Sweden)

    Daria Gotti

    Full Text Available OBJECTIVES: We studied survival and associated risk factors in an Italian nationwide cohort of HIV-infected individuals after an AIDS-defining cancer (ADC or non-AIDS-defining cancer (NADC diagnosis in the modern cART era. METHODS: Multi-center, retrospective, observational study of HIV patients included in the MASTER Italian Cohort with a cancer diagnosis from January 1998 to September 2012. Malignancies were divided into ADC or NADC on the basis of the Centre for Disease Control-1993 classification. Recurrence of cancer and metastases were excluded. Survivals were estimated according to the Kaplan-Meier method and compared according to the log-rank test. Statistically significant variables at univariate analysis were entered in a multivariate Cox regression model. RESULTS: Eight hundred and sixty-six cancer diagnoses were recorded among 13,388 subjects in the MASTER Database after 1998: 435 (51% were ADCs and 431 (49% were NADCs. Survival was more favorable after an ADC diagnosis than a NADC diagnosis (10-year survival: 62.7%±2.9% vs. 46%±4.2%; p = 0.017. Non-Hodgkin lymphoma had lower survival rates than patients with Kaposi sarcoma or cervical cancer (10-year survival: 48.2%±4.3% vs. 72.8%±4.0% vs. 78.5%±9.9%; p<0.001. Regarding NADCs, breast cancer showed better survival (10-year survival: 65.1%±14% than lung cancer (1-year survival: 28%±8.7%, liver cancer (5-year survival: 31.9%±6.4% or Hodgkin lymphoma (10-year survival: 24.8%±11.2%. Lower CD4+ count and intravenous drug use were significantly associated with decreased survival after ADCs or NADCs diagnosis. Exposure to cART was found to be associated with prolonged survival only in the case of ADCs. CONCLUSIONS: cART has improved survival in patients with an ADC diagnosis, whereas the prognosis after a diagnosis of NADCs is poor. Low CD4+ counts and intravenous drug use are risk factors for survival following a diagnosis of ADCs and Hodgkin lymphoma in the NADC group.

  17. Therapy of CF-Patients with Amitriptyline and Placebo - a Randomised, Double-Blind, Placebo-Controlled Phase IIb Multicenter, Cohort-Study

    Directory of Open Access Journals (Sweden)

    Lutz Nährlich

    2013-04-01

    Full Text Available Background/Aims: Several recent studies revealed an accumulation of ceramide in bronchial, tracheal and intestinal epithelial cells of mice and patients with cystic fibrosis (CF. Normalization of ceramide concentrations in lungs of CF mice employing the functional acid sphingomyelinase inhibitor amitriptyline also normalized mucociliary clearance, chronic inflammation and infection susceptibility to pulmonary P. aeruginosa in these mice. Methods: To test for a beneficial effect of amitriptyline in vivo, we performed a phase IIb randomised, double-blind, placebo-controlled study. Twenty-one CF patients were treated with 25 mg/d amitriptyline twice daily for 28 days. The placebo consisted of 19 patients and was also treated twice per day. The primary endpoint was the change in lung function in the intention-to-treat (ITT population. Secondary endpoints were ceramide levels in epithelial cells and safety. Results: After treatment, forced expiratory volume in 1 sec predicted (FEV1 increased 6.3±11.5% (p=0.08 in the ITT population (36 of 40 CF patients and 8.5±10% (p=0.013 in the per protocol (PP population (29 of 40 patients. Ceramide levels decreased in nasal epithelial cells after amitriptyline treatment. Amitriptyline had no severe and only mild and mostly transient adverse effects, i.e. xerostomia and tiredness. Conclusion: Amitriptyline is safe in CF-patients, increases FEV1 and reduces ceramide in lung cells of CF patients.

  18. Influence of the Deqi Sensation by Suspended Moxibustion Stimulation in Lumbar Disc Herniation: Study for a Multicenter Prospective Two Arms Cohort Study

    Directory of Open Access Journals (Sweden)

    Rixin Chen

    2013-01-01

    Full Text Available Moxibustion stimulates the Deqi (Qi arrival phenomenon. Many clinical observations have documented that the character of the Deqi was a composite heat-sensitive moxibustion sensation. In this prospective multicentre comparative observational nonrandomized study, 92 patients with moderate to severe LDH were included. This study consisted of two parallel arms (A: heat-sensitive moxibustion sensation group; B: nonheat-sensitive moxibustion sensation group. Moxibustion was applied in the following three acupuncture points simultaneously: Da Changshu (BL25, Wei Zhong (BL40, and A-Shi acupuncture point (tenderness. The adjusted mean total Modified-JOA score showed significant differences between the groups in the first week (10.32 ± 4.27 95% CI [9.23~11.40] versus control group 12.42 ± 5.02 [11.62~13.69], P=0.03. The outcome in the second week also presented significant differences in both groups (7.62 ± 4.80 [6.46~8.77] versus 10.56 ± 4.75 [9.35~11.76], P=0.005. Significant differences were also manifested in the follow-up period (P=0.007. It can be inferred that the existence of the Deqi (heat-sensitive moxibustion sensation phenomenon in the process of suspended moxibustion is closely related to the curative effect, and arrival of heat-sensitive moxibustion sensation could improve the clinical curative effect of moxibustion.

  19. Predicting cardiovascular disease morbidity and mortality in chronic kidney disease in Spain. The rationale and design of NEFRONA: a prospective, multicenter, observational cohort study

    Directory of Open Access Journals (Sweden)

    Roig Jordi

    2010-07-01

    Full Text Available Abstract Background Cardiovascular disease (CVD is the leading cause of morbidity and mortality in patients with chronic kidney disease (CKD. Cardiovascular risk assessment in this population is hampered by the failure of traditional risk factors to fully account for the elevated CVD risk (reverse epidemiology effect and the presence of emerging risk factors specifically related to kidney failure. Therefore, diagnostic tools capable of improving cardiovascular risk assessment beyond traditional risk factors are currently warranted. We present the protocol of a 4-year prospective study aimed to assess the predictive value of non-invasive imaging techniques and biomarkers for CVD events and mortality in patients with CKD. Methods From November 2009 to October 2010, 4137 asymptomatic adult patients with stages 2 to 5 CKD will be recruited from nephrology services and dialysis units throughout Spain. During the same period, 843 participants without CKD (control group will be recruited from lists of primary care physicians, only at baseline. During the follow-up, CVD events and mortality will be recorded from all CKD patients. Clinical and laboratory characteristics will be collected in a medical documentation sheet. Three trained itinerant teams will carry out a carotid ultrasound to assess intima-media thickness and presence of plaques. A composite atherosclerosis score will be constructed based on carotid ultrasound data and measurement of ankle-brachial index. In CKD patients, presence and type of calcifications will be assessed in the wall of carotid, femoral and brachial arteries, and in cardiac valves, by ultrasound. From all participants, blood samples will be collected and stored in a biobank to study novel biomarkers. Conclusions The NEFRONA study is the first large, prospective study to examine the predictive value of several non-invasive imaging techniques and novel biomarkers in CKD patients throughout Spain. Hereby, we present the protocol of this study aimed to explore the most effective way in which these tests can be integrated with traditional risk factors to maximize CVD detection in this population.

  20. Predicting cardiovascular disease morbidity and mortality in chronic kidney disease in Spain. The rationale and design of NEFRONA: a prospective, multicenter, observational cohort study

    OpenAIRE

    Roig Jordi; Sarró Felipe; Vidal Teresa; Valdivielso Jose; Coll Blai; Borràs Mercè; Martínez Montserrat; Junyent Mireia; Craver Lourdes; Fernández Elvira

    2010-01-01

    Abstract Background Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in patients with chronic kidney disease (CKD). Cardiovascular risk assessment in this population is hampered by the failure of traditional risk factors to fully account for the elevated CVD risk (reverse epidemiology effect) and the presence of emerging risk factors specifically related to kidney failure. Therefore, diagnostic tools capable of improving cardiovascular risk assessment beyond tradit...

  1. N=2 SUGRA BPS Multi-center solutions, quadratic prepotentials and Freudenthal transformations

    CERN Document Server

    Fernandez-Melgarejo, J J

    2013-01-01

    We present a detailed description of N=2 stationary BPS multicenter black hole solutions for quadratic prepotentials with an arbitrary number of centers and scalar fields making a systematic use of the algebraic properties of the matrix of second derivatives of the prepotential, $\\mathcal{S}$, which in this case is a scalar-independent matrix. In particular we obtain bounds on the physical parameter of the multicenter solution such as horizon areas and ADM mass. We discuss the possibility and convenience of setting up a basis of the symplectic vector space built from charge eigenvectors of the $\\ssigma$, the set of vectors $(\\Ppm q_a)$ with $\\Ppm$ $\\ssigma$-eigenspace proyectors. The anti-involution matrix $\\mathcal{S}$ can be understood as a Freudenthal duality $\\tilde{x}=\\ssigma x$. We show that this duality can be generalized to "Freudenthal transformations" $$x\\to \\lambda\\exp(\\theta \\ssigma) x= a x+b\\tilde{x}$$ under which the horizon area, ADM mass and intercenter distances scale up leaving constant the ...

  2. Quantitative analysis of tomographic stress thallium-201 myocardial scintigrams: A multicenter trial

    International Nuclear Information System (INIS)

    The accuracy of the previously developed and validated Cedars-Sinai Medical Center (CSMC) computer program for quantitative analysis of thallium-201 (201TI) stress myocardial tomograms was assessed in a multicenter trial consisting of 242 patients with coronary angiography and 76 with a low likelihood (LL) of coronary artery disease (CAD) involving various cameras, computers, and operators. The program utilized gender-matched normal limits developed from 35 LL patients at CSMC. The multicenter results as compared to those of 168 patients from CSMC were not significantly different with respect to the overall sensitivities (94% versus 95%) and specificities (44% versus 56%) for identification of CAD and normalcy rates which were determined in LL patients (82% for both) and with respect to identification of individual diseased arteries. The results indicate that our method for quantifying tomographic 201TI stress scintigrams utilizing standard normal limits can be applied at other institutions by different operators, using a variety of cameras and computers, with similar accuracy to that currently obtained at our institution

  3. A Pilot Feasibility Multicenter Study of Patients After Excision of Endometriosis

    Science.gov (United States)

    Tu, Frank; Bajzak, Krisztina; Lamvu, Georgine; Guzovsky, Olga; Agnelli, Rob; Peavey, Mary; Winer, Wendy; Albee, Robert; Sinervo, Ken

    2013-01-01

    Objective: To serve as a pilot feasibility study for a randomized study of excision versus ablation in the treatment of endometriosis by (1) estimating the magnitude of change in symptoms after excision only at multiple referral centers and (2) determining the proportion of women willing to participate in a randomized trial. Methods: We performed a multicenter prospective study of women undergoing excision for endometriosis (Canadian Task Force class II-3) at Duke University Center for Endometriosis Research & Treatment (currently the Saint Louis University Center for Endometriosis), Center for Endometriosis Care, Northshore University Health System, Memorial University (Canada), and Florida Hospital. The study comprised 100 female patients, aged 18 to 55 years, with endometriosis-suspected pelvic pain. The intervention was laparoscopic excision only of the abnormal peritoneum suspicious for endometriosis. The main outcome measures were quality of life, pelvic pain, dysmenorrhea, dyspareunia, and bowel and bladder symptoms. Results: The mean follow-up period was 8.5 months. Excision of endometriosis showed a significant reduction in all pain scores except bowel symptoms, as well as significant improvement in quality of life. Of the patients, 84% were willing to participate in a randomized study. Conclusions: Quality of life is a needed primary outcome for any randomized study comparing excision versus ablation. A multicenter comparative trial is feasible, although quality assurance would have to be addressed. Patients were willing to be randomized even at surgical referral centers. PMID:23743377

  4. Survival nomogram for curatively resected Korean gastric cancer patients: multicenter retrospective analysis with external validation.

    Directory of Open Access Journals (Sweden)

    Bang Wool Eom

    Full Text Available A small number of nomograms have been previously developed to predict the individual survival of patients who undergo curative resection for gastric cancer. However, all were derived from single high-volume centers. The aim of this study was to develop and validate a nomogram for gastric cancer patients using a multicenter database.We reviewed the clinicopathological and survival data of 2012 patients who underwent curative resection for gastric cancer between 2001 and 2006 at eight centers. Among these centers, six institutions were randomly assigned to the development set, and the other two centers were assigned to the validation set. Multivariate analysis using the Cox proportional hazard regression model was performed, and discrimination and calibration were evaluated by external validation.Multivariate analyses revealed that age, tumor size, lymphovascular invasion, depth of invasion, and metastatic lymph nodes were significant prognostic factors for overall survival. In the external validation, the concordance index was 0.831 (95% confidence interval, 0.784-0.878, and Hosmer-Lemeshow chi-square statistic was 3.92 (P = 0.917.We developed and validated a nomogram to predict 5-year overall survival after curative resection for gastric cancer based on a multicenter database. This nomogram can be broadly applied even in general hospitals and is useful for counseling patients, and scheduling follow-up.

  5. Multicenter evaluation of single-photon emission computed tomography quantification with third-party reconstruction software.

    Science.gov (United States)

    Kangasmaa, Tuija S; Constable, Chris; Hippeläinen, Eero; Sohlberg, Antti O

    2016-09-01

    Reliable and reproducible quantification is essential in many clinical situations. Previously, single-photon emission computed tomography (SPECT) has not been considered a quantitative imaging modality, but recent advances in reconstruction algorithm development have made SPECT quantitative. In this study, we investigate the reproducibility of SPECT quantification with phantoms in a multicenter setting using novel third-party reconstruction software. A total of five hospitals and eight scanners (three GE scanners and five Siemens scanners) participated in the study. A Jaszczak phantom without inserts was used to calculate counts to activity concentration conversion factors. The quantitative accuracy was tested using the NEMA-IEC phantom with six spherical inserts (diameters from 10 to 37 mm) filled to an 8 : 1 insert-background concentration ratio. Phantom studies were reconstructed at one central location using HERMES HybridRecon applying corrections for attenuation, collimator-detector response, and scatter. Spherical volumes of interest with the same diameter as the inserts were drawn on the images and recovery coefficients for the spheres were calculated. The coefficient of variation (CoV) of the NEMA-IEC phantom recovery coefficients ranged from ∼19 to 5% depending on the insert diameter so that the lowest CoV was obtained with the largest spheres. The intersite CoV was almost equal to intrasite CoV. In conclusion, quantitative SPECT is reproducible in a multicenter setting with third-party reconstruction software. PMID:27128824

  6. Development of monoclonal gammopathy under biotherapy in psoriasis: a French multicenter retrospective study.

    Science.gov (United States)

    Liegeon, Anne-Laure; Mahe, Emmanuel; Begon, Edouard; Poreaux, Claire; Barbaud, Annick; Esteve, Eric; Quiles-Tsimaratos, Nathalie; Avenel-Audran, Martine; Schoeffler, Amélie; Mery-Bossard, Laure; Pauwels, Christine; Girard, Céline; Maillard, Hervé; Barthelme, Dominique; Bernier, Claire; Chaby, Guillaume; Reguiai, Ziad; Nguyen-Thi, Phi Linh; Maccari, François; Schmutz, Jean-Luc

    2016-02-01

    Biotherapies or targeted therapies are fairly new treatments indicated for moderate to severe psoriasis. The side effects appear to be mainly infectious or cancerous. The role of biotherapies in the development of a pre-cancerous condition, monoclonal gammopathy of undetermined significance (MGUS), has recently been debated in the literature. To evaluate the incidence of MGUS in psoriasis patients treated with biotherapy. This study was a French multicenter retrospective study carried out through the French multicenter study group RESOPSO. Data on the results of serum protein electrophoreses performed before and within at least six months after the start of the biotherapy were collected. Demographic data, medical history, and psoriasis treatment history were specified. Four hundred and forty three patients were eligible for inclusion. Of these, three presented with monoclonal gammopathy for which the assessment was in favor of MGUS. The average treatment period was 19.7 months. Six patients presented with MGUS prior to the treatment. These patients' immunoglobulin levels remained stable, with an average remission of 24 months. Only psoriatic rheumatism appeared to be statistically linked to MGUS. The incidence and frequency of MGUS in psoriasis patients treated with biotherapy do not appear to increase relative to the general population. PMID:26878712

  7. Cohort profile: systemic lupus erythematosus in Sweden: the Swedish Lupus Linkage (SLINK) cohort

    OpenAIRE

    Arkema, Elizabeth V; Simard, Julia F

    2015-01-01

    Purpose A cohort of individuals with systemic lupus erythematosus (SLE) was identified through linkage of several national registers to investigate important epidemiological questions using not only population-based data to minimise selection bias, but also to identify matched comparators from the general population to serve as controls. This cohort was established to overcome the general dearth of data in SLE epidemiology. Participants All individuals registered in Sweden with a personal ide...

  8. A diminishing population whose every cohort more than replaces itself

    OpenAIRE

    Robert Schoen; JONSSON, STEFAN H.

    2003-01-01

    We observe that a dynamic population model can have period fertility that is always below replacement and cohort fertility that is always above replacement. We ask whether such a paradoxical population will get larger or smaller, and show that it must become smaller. Cohort replacement does not imply population replacement, and emphasizing fertility timing and cohort fertility ignores the issue of relative cohort size. The resolution of this apparent paradox reinforces the importance of the l...

  9. Within-Cohort Age-Related Differences in Cognitive Functioning

    OpenAIRE

    Salthouse, Timothy A.

    2013-01-01

    It is widely accepted that the level of cognitive functioning can be influenced by characteristics of the environment that change over time. Many developmental researchers have referred to these influences as cohort effects, and have used year of birth as the basis for determining cohort membership. Furthermore, age-related differences in cognitive functioning are sometimes assumed to be primarily attributable to cohort differences, which implies that differences between birth cohorts should ...

  10. Case–Cohort Analysis with Accelerated Failure Time Model

    OpenAIRE

    Kong, Lan; Cai, Jianwen

    2008-01-01

    In a case–cohort design, covariates are assembled only for a subcohort that is randomly selected from the entire cohort and any additional cases outside the subcohort. This design is appealing for large cohort studies of rare disease, especially when the exposures of interest are expensive to ascertain for all the subjects. We propose statistical methods for analyzing the case–cohort data with a semiparametric accelerated failure time model that interprets the covariates effects as to acceler...

  11. Establishment of Elevated Serum Levels of IL-10, IL-8 and TNF-β as Potential Peripheral Blood Biomarkers in Tubercular Lymphadenitis: A Prospective Observational Cohort Study

    Science.gov (United States)

    Abhimanyu; Bose, Mridula; Varma-Basil, Mandira; Jain, Ashima; Sethi, Tavpritesh; Tiwari, Pradeep Kumar; Agrawal, Anurag; Banavaliker, Jayant Nagesh; Bhowmick, Kumar Tapas

    2016-01-01

    Background Tubercular lymphadenitis (TL) is the most common form of extra-pulmonary tuberculosis (TB) consisting about 15–20% of all TB cases. The currently available diagnostic modalities for (TL), are invasive and involve a high index of suspicion, having limited accuracy. We hypothesized that TL would have a distinct cytokine signature that would distinguish it from pulmonary TB (PTB), peripheral tubercular lymphadenopathy (LNTB), healthy controls (HC), other lymphadenopathies (LAP) and cancerous LAP. To assess this twelve cytokines (Tumor Necrosis Factor (TNF)—α, Interferon (IFN) -γ, Interleukin (IL)-2, IL-12, IL-18, IL-1β, IL-10, IL-6, IL-4, IL-1Receptor antagonist (IL-1Ra), IL-8 and TNF-β, which have a role in pathogenesis of tuberculosis, were tested as potential peripheral blood biomarkers to aid the diagnosis of TL when routine investigations prove to be of limited value. Methods and Findings A prospective observational cohort study carried out during 2010–2013. This was a multi-center study with three participating hospitals in Delhi, India where through random sampling cohorts were established. The subjects were above 15 years of age, HIV-negative with no predisposing ailments to TB (n = 338). The discovery cohort (n = 218) had LNTB (n = 50), PTB (n = 84) and HC (n = 84). The independent validation cohort (n = 120) composed of patients with cancerous LAP (n = 35), other LAP (n = 20) as well as with independent PTB (n = 30), LNTB (n = 15) and HC (n = 20). Eight out of twelve cytokines achieved statistical relevance upon evaluation by pairwise and ROC analysis. Further, variable selection using random forest backward elimination revealed six serum biosignatures including IL-12, IL-4, IL-6, IL-10, IL-8 and TNF-β as optimal for classifying the LNTB status of an individual. For the sake of clinical applicability we further selected a three analyte panel (IL-8, IL-10 and TNF-β) which was subjected to multinomial modeling in the independent

  12. A Synthetic Cohort Analysis of Canadian Housing Careers

    OpenAIRE

    Thomas F. Crossley; Yuri Ostrovsky

    2003-01-01

    This paper uses a time-series of cross-sections drawn from three different surveys to explore life-cycle profiles of housing arrangements in Canada. Synthetic cohort (quasi-panel) methods are employed to disentangle age profiles from cohort effects. The results suggest limited "downsizing" in later life. Potential biases arising from changes in cohort composition are also explored.

  13. MRI, PET/CT and ultrasound in the preoperative staging of endometrial cancer - A multicenter prospective comparative study

    DEFF Research Database (Denmark)

    Antonsen, Sofie Leisby; Jensen, Lisa Neerup; Loft, Annika;

    2013-01-01

    OBJECTIVES: The aim of this prospective multicenter study was to evaluate and compare the diagnostic performance of PET/CT, MRI and transvaginal two-dimensional ultrasound (2DUS) in the preoperative assessment of endometrial cancer (EC). METHODS: 318 consecutive women with EC were included when r...

  14. An international multicenter study on the effectiveness of a denture adhesive in maxillary dentures using disposable gnathometers

    NARCIS (Netherlands)

    de Baat, Cees; van 't Hof, Martin; van Zeghbroeck, Lieve; Ozcan, Mutlu; Kalk, Warner

    2007-01-01

    No consensus has been achieved on whether denture adhesives are beneficial adjuncts in denture-wearers management. The purpose of this international multicenter study was to determine objectively the effect of a denture adhesive (Kukident) on the retention of complete maxillary dentures using dispos

  15. An international multicenter study on the effectiveness of a denture adhesive in maxillary dentures using disposable gnathometers.

    NARCIS (Netherlands)

    Baat, C. de; Hof, M.A. van 't; Zeghbroeck, L. van; Ozcan, M.; Kalk, W.

    2007-01-01

    No consensus has been achieved on whether denture adhesives are beneficial adjuncts in denture-wearers management. The purpose of this international multicenter study was to determine objectively the effect of a denture adhesive (Kukident) on the retention of complete maxillary dentures using dispos

  16. “Remotion” Total Wrist Arthroplasty: Preliminary Results of a Prospective International Multicenter Study of 215 Cases

    DEFF Research Database (Denmark)

    Herzberg, Guillaume; Boeckstyns, Michel Ernest Henri; Sorensen, Allan Ibsen;

    2012-01-01

    This study reports the current results of an international multicenter study of one last generation total wrist arthroplasty (TWA) ("ReMotion," Small Bone Innovation, Morristown, PA). The two first authors (G.H. and M.B.) built a Web-based prospective database including clinical and radiological ...

  17. ICA-based artifact removal diminishes scan site differences in multi-center resting-state fMRI

    NARCIS (Netherlands)

    R.A. Feis (Rogier A.); S.M. Smith (Stephen); N. Filippini (Nicola); G. Douaud (Gwenaëlle); E.G.P. Dopper (Elise); V. Heise (Verena); A.J. Trachtenberg (Aaron J.); J.C. van Swieten (John); M.A. van Buchem (Mark); S.A.R.B. Rombouts (Serge); C.E. Mackay (Clare E.)

    2015-01-01

    textabstractResting-state fMRI (R-fMRI) has shown considerable promise in providing potential biomarkers for diagnosis, prognosis and drug response across a range of diseases. Incorporating R-fMRI into multi-center studies is becoming increasingly popular, imposing technical challenges on data acqui

  18. Standardization of measuring power output during wheelchair propulsion on a treadmill Pitfalls in a multi-center study

    NARCIS (Netherlands)

    de Groot, S; Zuidgeest, M; van der Woude, L H V

    2006-01-01

    OBJECTIVE: In a multi-center study the power output of wheelchair propulsion, attained by a wheelchair drag test, differed among rehabilitation centers. The purpose of this study was to investigate what causes the differences in drag force among centers. METHODS: A set of standardized drag tests was

  19. Multicenter assessment of the reproducibility of volumetric radiofrequency-based intravascular ultrasound measurements in coronary lesions that were consecutively stented

    DEFF Research Database (Denmark)

    Huisman, Jennifer; Egede, Rasmus; Rdzanek, Adam;

    2012-01-01

    To assess in a multicenter design the between-center reproducibility of volumetric virtual histology intravascular ultrasound (VH-IVUS) measurements with a semi-automated, computer-assisted contour detection system in coronary lesions that were consecutively stented. To evaluate the reproducibility...

  20. Alcohol Consumption among University Students in North Rhine-Westphalia, Germany--Results from a Multicenter Cross-Sectional Study

    Science.gov (United States)

    Akmatov, Manas K.; Mikolajczyk, Rafael T.; Meier, Sabine; Kramer, Alexander

    2011-01-01

    Objective: To assess alcohol use and problem drinking among university students in the German Federal State of North Rhine-Westphalia (NRW) and to examine the associated factors. Method: A multicenter cross-sectional study was conducted in 16 universities in 2006-2007 in NRW by a standardized questionnaire and 3,306 students provided information…

  1. Weight and body mass index in relation to irradiated volume and to overall survival in patients with oropharyngeal cancer: a retrospective cohort study

    International Nuclear Information System (INIS)

    Weight loss is a common problem in patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN) treated with radiotherapy (RT). The aims of the present study were to determine if treated volume (TV), as a measure of the radiation dose burden, can predict weight loss in patients with oropharyngeal cancer and to analyze weight loss and body mass index (BMI) in the same patient group in relation to 5-year overall survival. The ARTSCAN trial is a prospective, randomized, multicenter trial in patients with SCCHN. Nutritional data from the ARTSCAN trial were analyzed retrospectively using univariate and multivariate statistical methods based on information on percentage weight loss from the start of RT up to five months after the termination of RT (study cohort 1, n = 232) and information on patients’ BMI at the start of RT (study cohort 2, n = 203). TV was defined as the volume of the patient receiving at least 95% of the prescribed dose. TV64.6Gy encompasses macroscopic tumor and TV43.7Gy elective lymph nodes of the neck. TV64.6Gy and TV43.7Gy were both significantly correlated with higher weight loss up to five months after the termination of RT in study cohort 1 (p < 0.001 for both). BMI at the start of RT was shown to be a prognostic factor for 5-year overall survival in study cohort 2 but weight loss was not. The hazard ratios and 95% confidence intervals were 3.78 (1.46–9.75) and 2.57 (1.43–4.62) in patients with underweight and normal weight, respectively. TV can predict weight loss during RT in patients with oropharyngeal cancer regardless of clinical stage. A high BMI (>25 kg/m2) at the start of RT is positively associated with survival in patients with oropharyngeal cancer

  2. The CONSTANCES cohort: an open epidemiological laboratory

    Directory of Open Access Journals (Sweden)

    Zins Marie

    2010-08-01

    Full Text Available Abstract Background Prospective cohorts represent an essential design for epidemiological studies and allow for the study of the combined effects of lifestyle, environment, genetic predisposition, and other risk factors on a large variety of disease endpoints. The CONSTANCES cohort is intended to provide public health information and to serve as an "open epidemiologic laboratory" accessible to the epidemiologic research community. Although designed as a "general-purpose" cohort with very broad coverage, it will particularly focus on occupational and social determinants of health, and on aging. Methods/Design The CONSTANCES cohort is designed as a randomly selected representative sample of French adults aged 18-69 years at inception; 200,000 subjects will be included over a five-year period. At inclusion, the selected subjects will be invited to fill a questionnaire and to attend a Health Screening Center (HSC for a comprehensive health examination: weight, height, blood pressure, electrocardiogram, vision, auditory, spirometry, and biological parameters; for those aged 45 years and older, a specific work-up of functional, physical, and cognitive capacities will be performed. A biobank will be set up. The follow-up includes a yearly self-administered questionnaire, and a periodic visit to an HSC. Social and work-related events and health data will be collected from the French national retirement, health and death databases. The data that will be collected include social and demographic characteristics, socioeconomic status, life events, behaviors, and occupational factors. The health data will cover a wide spectrum: self-reported health scales, reported prevalent and incident diseases, long-term chronic diseases and hospitalizations, sick-leaves, handicaps, limitations, disabilities and injuries, healthcare utilization and services provided, and causes of death. To take into account non-participation at inclusion and attrition throughout the

  3. Multicenter Orthopaedic Outcome Network Early Anti-inflammatory Treatment in Patients with Acute ACL Tear” (MOON-AAA) Clinical Trial

    Science.gov (United States)

    Lattermann, Christian; Proffitt, Mary; Huston, Laura J.; Gammon, Lee; Johnson, Darren L.; Kraus, Virginia B.; Spindler, Kurt P.

    2016-01-01

    Objectives: We present the early results from the “Multicenter Orthopaedic Outcome Network Early Anti-inflammatory Treatment in Patients with Acute ACL Tear and Painful Effusions” (MOON-AAA) clinical trial (figure 1). This trial allows for a well controlled prospective cohort of patients with isolated ACL injury at risk for OA. We compared the effect of a single versus a repeated dosage of Kenalog within the first two weeks after ACL injury and its effect on chondral degradation in the first 4 weeks prior to surgical reconstruction of the ACL. Methods: 49 patients with isolated ACL tears were enrolled. Knee joints were aspirated and patients received an injection with 40 mg Kenalog either within 4 days, 10 days, both time points or not at all (saline injection control). Serum, synovial fluid and urine were collected at 3 time points. Permutated block randomization, triple blinding, independent monitoring and standardized x-ray was performed to comply with GCP standards. Patient reported outcomes were collected at 6 time points up to 6 months post-ACL reconstruction(IKDC, KOOS and Marx activity level). A standardized synovial fluid biomarker panel was analyzed according to OARSI guidelines. Statistical analysis were performed using SAS mixed models analysis. Results: Serum analysis shows significant change after injury. Chondrodegradatory markers such as CTX-II, MMP-1 and MMP-3 as well as COMP indicate a progressive destruction of chondral matrix and collagen breakdown . There is a dramatic (250%) increase of CTX-II in the first 4 weeks. Matrix proteins such as MMP-1 and 3 as well as COMP show an initial increase and then a steep decline (see figure 1). Inflammatory markers (IL-1 alpha, IL-1beta, IRAP) show a decline from the time of injury. IL-1 alpha, however shows a dramatic uptake after week 2. This longitudinal data confirms a dramatic onset of early osteoarthritic biomarker profiles immediately after ACL injury as measured in synovial fluid

  4. Case -cohort design in practice - experiences from the MORGAM Project

    OpenAIRE

    Kulathinal, S.; Karvanen, J.; Saareka, O.; K. Kuulasmaa; Evans, Alun; Yarnell, John

    2007-01-01

    When carefully planned and analysed, the case-cohort design is a powerful choice for follow-up studies with multiple event types of interest. While the literature is rich with analysis methods for case-cohort data, little is written about the designing of a case-cohort study. Our experiences in designing, coordinating and analysing the MORGAM case-cohort study are potentially useful for other studies with similar characteristics. The motivation for using the case-cohort design in the MORGAM g...

  5. The Danish National Cohort Study (DANCOS)

    DEFF Research Database (Denmark)

    Helweg-Larsen, Karin; Kjøller, Mette; Davidsen, Michael;

    2003-01-01

    -interview survey. As part of the national health interview survey programme, three nation-wide surveys were conducted in 1986/1987, 1991 and 1994. The samples in the three cohorts consisted of 23,096 adult Danes ages 16 years and older, and 18,296 (79.2%) were personally interviewed on socio-economic status...... Service Register recorded 980,043 contacts with general practitioners and specialist physicians. For 1943-1996, the Danish cancer Registry contained information about one or more cancer diseases among 1,432 people. A total of 4,334 people in the 1994 cohort were re-interview in 2000. DANCOS allows...... for a wide range of analysis in a historical prospective design of determinants of morbidity and mortality, of health care utilization and of the social effects of ill health. DANCOS also allows studies of methodological issues, including analyzing the characteristics of non-respondents. Udgivelsesdato: 2003...

  6. Risk set sampling in epidemiologic cohort studies

    OpenAIRE

    Langholz, Bryan; Goldstein, Larry

    1996-01-01

    Recent work has extended the methods for the analysis of nested case-control studies to accomodate a broad variety of risk set sampling designs. These results have implications for the design of sampled epidemiologic cohort studies. We describe a model which is a natural extension of the Cox proportional hazards model and may be used to estimate parameters from sampled risk set data. We illustrate how these techniques may be used to solve three diverse design and analysis problems from epidem...

  7. Race, Ethnicity, Psychosocial Factors, and Telomere Length in a Multicenter Setting.

    Directory of Open Access Journals (Sweden)

    Shannon M Lynch

    Full Text Available Leukocyte telomere length(LTL has been associated with age, self-reported race/ethnicity, gender, education, and psychosocial factors, including perceived stress, and depression. However, inconsistencies in associations of LTL with disease and other phenotypes exist across studies. Population characteristics, including race/ethnicity, laboratory methods, and statistical approaches in LTL have not been comprehensively studied and could explain inconsistent LTL associations.LTL was measured using Southern Blot in 1510 participants from a multi-ethnic, multi-center study combining data from 3 centers with different population characteristics and laboratory processing methods. Main associations between LTL and psychosocial factors and LTL and race/ethnicity were evaluated and then compared across generalized estimating equations(GEE and linear regression models. Statistical models were adjusted for factors typically associated with LTL(age, gender, cancer status and also accounted for factors related to center differences, including laboratory methods(i.e., DNA extraction. Associations between LTL and psychosocial factors were also evaluated within race/ethnicity subgroups (Non-hispanic Whites, African Americans, and Hispanics.Beyond adjustment for age, gender, and cancer status, additional adjustments for DNA extraction and clustering by center were needed given their effects on LTL measurements. In adjusted GEE models, longer LTL was associated with African American race (Beta(β(standard error(SE = 0.09(0.04, p-value = 0.04 and Hispanic ethnicity (β(SE = 0.06(0.01, p-value = 0.02 compared to Non-Hispanic Whites. Longer LTL was also associated with less than a high school education compared to having greater than a high school education (β(SE = 0.06(0.02, p-value = 0.04. LTL was inversely related to perceived stress (β(SE = -0.02(0.003, p<0.001. In subgroup analyses, there was a negative association with LTL in African Americans with a high

  8. Incidence and risk factors of chronic renal disease in a cohort of Greek HIV-1-infected adults

    Directory of Open Access Journals (Sweden)

    V Sakka

    2012-11-01

    Full Text Available Background Chronic kidney disease (CKD in HIV-infected patients is associated with both HIV and non-HIV-related factors. Initial renal dysfunction is silent and detectable only by laboratory tests such as the glomerular filtration rate (GFR estimated by the Cockcroft-Gault equation. Our objective was to assess possible risk factors for CKD in a cohort of Greek HIV-1-infected adults. Methods Patients in the AMACS (Athens Multicenter AIDS Cohort Study cohort with at least two available creatinine values were enrolled in the study. Renal dysfunction was defined as eGFR below 90 mL/min/1.73 m2. The Kaplan-Meier estimator and the Cox proportional hazards model were used to analyze the occurrence and predictors of renal dysfunction. Results A total of 1073 patients were enrolled in the study; 255 (23.76% had baseline eGFR below 90 mL/min/1.73 m2 and were excluded. Characteristics of the study population: men 88.4%, MSM 62.6%, median baseline age, CD4+count and viral load were 32.6 years, 413 cells/µL and 3.77 log10 copies/mL, respectively. 240 (29.3% patients experienced an eGFR decrease below 90 mL/min/1.73 m2 during follow-up period. Older age, female gender, heterosexual mode of transmission, lower baseline eGFR (all p<0.001, lower baseline CD4+(p=0.001, stage C (p=0.023, administration of cART (p<0.001 or other nephrotoxic agent (p=0.035 were the major risk factors in univariable analysis. Multivariable analysis identified older age [hazard ratio (HR 1.289 per 10 years, p<0.001] and female gender (HR vs male: 1.899, p<0.001, as the major factors associated with increased hazard of developing CRD, whereas baseline eGFR <110 (HR vs eGFR <110: 0.245, p<0.001 and current CD4+count ≥350 cells/µL (HR 0.564, p=0.003 were significant protective factors. Conclusion In this large cohort of HIV-infected Greek patients, almost one-third (29.3% experienced some degree of renal dysfunction during HIV infection. Older age and female gender were major

  9. Poststroke depression and risk of recurrent stroke at 1 year in a Chinese cohort study.

    Directory of Open Access Journals (Sweden)

    Huai Wu Yuan

    Full Text Available BACKGROUND: Studies show that poststroke depression (PSD increases mortality risk at 1 year. However, whether PSD increases the risk of recurrent stroke at 1 year remains unclear. This study was to investigate whether PSD at 2 weeks following a stroke could increase risk of recurrent stroke at 1 year. METHODS AND RESULTS: This was a multi-centered prospective cohort study. A total of 2306 patients with acute stroke were enrolled in our study. PSD was diagnosed according to the criteria set by the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV. The outcomes of recurrent stroke were followed up via face-to-face or phone interview. A total of 1713 patients had complete follow-up data, with 481 (28.1% cases of PSD and 158 (9.2% cases of cumulative recurrent stroke at 1 year. Multivariate logistic regression analysis showed a 49% increase of OR of recurrent stroke at 1 year in patients with PSD, compared to patients without PSD following a stroke (OR=1.49, 95%CI: 1.03-2.15. There was no significant correlation between anti-depressant drugs and the risk of recurrent stroke at 1 year following a stroke (OR=1.96, 95%: CI 0.95-4.04. CONCLUSIONS: Based on the DSM-IV diagnostic criteria, nearly 3 out of 10 hospitalized stroke patients in China were diagnosed with PSD at 2 weeks following a stroke. PSD is associated with a higher risk of recurrent stroke at 1 year. Our study did not find benefit of anti-depressant drugs in reducing such risk.

  10. Archaeometry of ceramic materials: an evaluation of the andalusian experience

    Directory of Open Access Journals (Sweden)

    Cordero Ruiz, Tomás

    2006-06-01

    Full Text Available This paper assesses the impact that the introduction of scientific methods for materials characterisation (conventionally grouped under the label of Archaeometry has had in the methodological configuration of Spanish archaeology over the last two decades. This is achieved through a bibliometric study of publications dealing with characterisation of archaeological ceramics from Andalucía (southern Spain. The variables handled in this study include aspects such as the number of sampled sites and items, their geographical provenance, the chronological and functional dimensions of the archaeological contexts they were taken from as well as the analytical techniques employed in their study.

    Este artículo intenta valorar el impacto que la introducción de métodos de caracterización de materiales procedentes de la física y la química (y agrupados habitualmente bajo la denominación genérica de Arqueometría ha tenido en la configuración metodológica de la investigación arqueológica de nuestro país durante las últimas dos décadas. Para ello se realiza un análisis bibliométrico de un ámbito específico de la aplicación de las técnicas arqueométricas, cual es el de la caracterización de materiales cerámicos dentro de la Arqueología andaluza. Las variables tenidas en cuenta incluyen aspectos tales como la cantidad de sitios arqueológicos muestreados y de muestras analizadas, su procedencia geográfica, los contextos cronológicos y funcionales de los que las muestras fueron tomadas y las técnicas analíticas empleadas.

  11. Environmental pressures in Andalusian golf courses: a factorial analysis

    OpenAIRE

    Riquel Ligero, Francisco; Vargas Sánchez, Alfonso

    2012-01-01

    El presente trabajo se marca como objetivo principal la tipificación del entorno institucional de carácter medioambiental en el que operan los campos de golf andaluces. Para ello se ha realizado un análisis factorial que ha permitido identificar las presiones propuestas por la Teoría Institucional y que son fuentes de isomorfismo en las organizaciones. En concreto, hemos vinculado este tipo de presiones al comportamiento medioambiental de los campos de golf andaluces, contribuy...

  12. Sierra Elvira limestone: petrophysical characteristics of an Andalusian heritage stone

    Directory of Open Access Journals (Sweden)

    Valverde, I.

    2008-06-01

    Full Text Available “Sierra Elvira stone” is one of the ornamental building stones most widely used in the historical monuments of eastern Andalusia. A Liassic age limestone, it appears in the central section of the Baetic Mountains and more specifically in the Middle Subbaetic domain. While the most common variety is a crinoid limestone, a micritic limestone of the same age has also been quarried, albeit in much smaller quantities. These stones form very thick beds, up to nearly 5 m deep, that run in consistently parallel lines and have a dip angle that facilitates quarrying.With petrographic, physical and mechanical properties that ensure stone strength and durability, it is a high quality building material suitable for both structural and ornamental purposes. These properties can be attributed to the minimal open porosity and concomitant excellent water resistance that characterize the stone, as well as to its high mechanical strength and low textural anisotropy, both elastic and mechanical. With such attributes, the stone can be successfully used for any number of purposes, including decorative stonework (portals, fountains, plinths, structural members (column shafts and bases or urban curbing and paving. Intervention on Sierra de Elvira limestone structures should be limited to cleaning or repair, for consolidating or protective materials are scantly effective.La “Piedra de Sierra Elvira” constituye una de las piedras ornamentales más significativas del Patrimonio Arquitectónico de Andalucía Oriental. Es una roca caliza del Lias que aflora en el Subbético Medio del sector central de las Cordilleras Béticas. El litotipo más explotado es una caliza con crinoides, en bastante menor importancia se ha extraído también otra caliza micrítica de la misma edad. Los bancos son muy potentes, en algunos casos de más de 5 m, con un paralelismo constante y un buzamiento que favorece su explotación en los frentes de cantera.Sus características petrográfica y físico-mecánica le confieren una calidad técnica y durabilidad muy notables para su utilización como material de construcción estructural y ornamental. Los principales parámetros que determinan estas cualidades son su mínima porosidad eficaz y asociado a ello sus excelentes propiedades hídricas, así como sus elevadas resistencias mecánicas y el bajo coeficiente de anisotropía textural, tanto elástico como mecánico. Este conjunto de características ha permitido su utilización en muy diversas funciones constructivas: en elementos decorativos (portadas, fuentes, zócalos, estructurales (columnas, basas o en piezas del mobiliario urbano: bordillos, losas, casi siempre presentando un estado de conservación bastante aceptable. La intervención en elementos constructivos de esta piedra debe limitarse a su limpieza o reintegración, ya que no resulta suficientemente efectiva la aplicación de productos de consolidación o de protección.

  13. Chasing the Effects of Pre-Analytical Confounders - A Multicenter Study on CSF-AD Biomarkers

    DEFF Research Database (Denmark)

    Leitão, Maria João; Baldeiras, Inês; Herukka, Sanna-Kaisa;

    2015-01-01

    INTRODUCTION: Core cerebrospinal fluid (CSF) biomarkers - Aβ42, Tau, and phosphorylated Tau (pTau) - have been recently incorporated in the revised criteria for Alzheimer's disease (AD). However, their widespread clinical application lacks standardization. Pre-analytical sample handling and storage...... play an important role in the reliable measurement of these biomarkers across laboratories. AIM: In this study, we aim to surpass the efforts from previous studies, by employing a multicenter approach to assess the impact of less studied CSF pre-analytical confounders in AD-biomarkers quantification....... METHODS: Four different centers participated in this study and followed the same established protocol. CSF samples were analyzed for three biomarkers (Aβ42, Tau, and pTau) and tested for different spinning conditions [temperature: room temperature (RT) vs. 4°C; speed: 500 vs. 2000 vs. 3000 g], storage...

  14. Multicenter study of nursing role complexity on environmental stressors and emotional exhaustion.

    Science.gov (United States)

    Solomon, Deborah; Singleton, Kathleen A; Sun, Zhiyuan; Zell, Katrina; Vriezen, Kathryn; Albert, Nancy M

    2016-05-01

    Among nurses, work and cognitive complexity patterns of care were previously associated with environmental stressors, but it is unknown if complexity patterns are also associated with emotional exhaustion. A multicenter sample of hospital nurses (N=281) completed valid, reliable questionnaires. Data were analyzed using multivariable modeling. Registered nurse characteristics did not vary by work setting. Overall mean (standard deviation [SD]) standardized complexity of care score was 45.82 (13.73), reflecting moderate complexity during 3-hour work periods. Nurses experienced greater cognitive complexity patterns than work complexity patterns (pemotional exhaustion. Higher work complexity pattern score was associated with more environmental stressors (p=0.009), but there was no association between overall complexity of care or cognitive complexity pattern and environmental stressors. Interventions that reduce environmental stressors might reduce work complexity of care. PMID:27091253

  15. A prospective multicenter study evaluating skin tolerance to standard hand hygiene techniques.

    Science.gov (United States)

    Chamorey, Emmanuel; Marcy, Pierre-Yves; Dandine, Marc; Veyres, Patricia; Negrin, Nadine; Vandenbos, Frederic; Duval, Marie-Josée; Lambert, Sylvain; Mazzoni, Laëtitia; Chapuis, Viviane; Bodokh, Isaac; Sacleux, Paul

    2011-02-01

    We performed a prospective multicenter study to assess the dryness and irritation of the hands in health care facilities, and to evaluate whether that disinfection with an alcohol-based hand rub (ABHR) is better tolerated than classic handwashing with mild soap and water. Our study was conducted in 9 sites in the summer and winter. A team of investigators evaluated dryness and irritation. This study takes into account most of the individual and environmental risk factors (age, sex, use of a protective agent, constitutional factors, personal factors, external factors, institution, function, and number of consecutive working days). The results from the 1932 assessments collected show that traditional handwashing is a risk factor for dryness and irritation, whereas the use of ABHR causes no skin deterioration and might have a protective effect, particularly in intensive use. These results provide a strong argument to counter the rear-guard resistance to the use of ABHRs. PMID:20650547

  16. Invariant exchange perturbation theory for multicenter systems: Time-dependent perturbations

    International Nuclear Information System (INIS)

    A formalism of exchange perturbation theory (EPT) is developed for the case of interactions that explicitly depend on time. Corrections to the wave function obtained in any order of perturbation theory and represented in an invariant form include exchange contributions due to intercenter electron permutations in complex multicenter systems. For collisions of atomic systems with an arbitrary type of interaction, general expressions are obtained for the transfer (T) and scattering (S) matrices in which intercenter electron permutations between overlapping nonorthogonal states belonging to different centers (atoms) are consistently taken into account. The problem of collision of alpha particles with lithium atoms accompanied by the redistribution of electrons between centers is considered. The differential and total charge-exchange cross sections of lithium are calculated

  17. [Optimized interval treatment of eczema with fluprednidene. A multicenter double-blind study].

    Science.gov (United States)

    Mahrle, G; Wemmer, U; Matthies, C

    1989-09-15

    In a multicenter double-blind study, 44 patients suffering from eczema were bilaterally treated with 0.1% fluprednidene-21-acetate over 21 days. Continuous application twice a day was compared with intermittent therapy, i.e. 1 day intermission (15 patients), 2 days intermission (16 patients) and 3 days intermission (13 patients) using the cream base. Final evaluation was based on 11 criteria. All regimens, continuous and intermittent, proved effective (at least 90% reduction of the lesions). Treatment with 3 days intermission showed the same favorable results as continuous application, although the amount of glucocorticoids applied was 75% less. Measurements of the skin fold thickness (SFT) in healthy controls did not indicate any atrophy after treatment with fluprednidene under the same conditions as the eczema patients or under occlusion for up to 21 days. Clobetasol-17-propionate, in contrast, significantly reduced the SFT already after application of only 1 week. PMID:2683439

  18. Endoscopic ultrasound elastography for evaluation of lymph nodes and pancreatic masses: a multicenter study

    DEFF Research Database (Denmark)

    Giovannini, Marc; Thomas, Botelberge; Erwan, Bories;

    2009-01-01

    AIM: To evaluate the ability of endoscopic ultrasound (EUS) elastography to distinguish benign from malignant pancreatic masses and lymph nodes. METHODS: A multicenter study was conducted and included 222 patients who underwent EUS examination with assessment of a pancreatic mass (n = 121) or lymph...... study was performed. RESULTS: The sensitivity and specificity of EUS elastography to differentiate benign from malignant pancreatic lesions are 92.3% and 80.0%, respectively, compared to 92.3% and 68.9%, respectively, for the conventional B-mode images. The sensitivity and specificity of EUS...... elastography to differentiate benign from malignant lymph nodes was 91.8% and 82.5%, respectively, compared to 78.6% and 50.0%, respectively, for the B-mode images. The kappa coefficient was 0.785 for the pancreatic masses and 0.657 for the lymph nodes. CONCLUSION: EUS elastography is superior compared to...

  19. Multicenter Safety and Immunogenicity Trial of an Attenuated Measles Vaccine for NHP.

    Science.gov (United States)

    Yee, Joann L; McChesney, Michael B; Christe, Kari L

    2015-10-01

    Measles is a highly contagious viral disease in NHP. The infection can range from asymptomatic to rapidly fatal, resulting in significant morbidity and mortality in captive populations. In addition to appropriate quarantine practices, restricted access, the immunization of all personnel in contact with NHP, and the wearing of protective clothing including face masks, measles immunization further reduces the infection risk. Commercially available measles vaccines are effective for use in NHP, but interruptions in their availability have prevented the implementation of ongoing, consistent vaccination programs. This need for a readily available vaccine led us to perform a broad, multicenter safety and immunogenicity study of another candidate vaccine, MVac (Serum Institute of India), a monovalent measles vaccine derived from live Edmonston-Zagreb strain virus that had been attenuated after 22 passages on human diploid cells. PMID:26473350

  20. Reporting and evaluation of HIV-related clinical endpoints in two multicenter international clinical trials

    DEFF Research Database (Denmark)

    Lifson, A; Rahme, FS; Belloso, WH; Dragsted, Ulrik Bak; El-Sadr, WM; Gatell, JM; Hoy, JF; Krum, EA; Nelson, R; Pedersen, C; Pett, SL; Davey, RT

    2006-01-01

    adjudication between reviewers before diagnostic certainty was assigned. CONCLUSION: Important requirements for HIV trials using clinical endpoints include objective definitions of "confirmed" and "probable," a formal reporting process with adequate information and supporting source documentation, evaluation......PURPOSE: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. METHOD: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression and...... death in HIV-infected patients receiving antiretroviral therapy. We report definitions used for HIV progression of disease endpoints, procedures for site reporting of such events, processes for independent review of reported events by an Endpoint Review Committee (ERC), and the procedure for...

  1. Two-year follow-up of an open-label multicenter study of polyacrylamide hydrogel (Bulkamid®) for female stress and stress-predominant mixed incontinence

    DEFF Research Database (Denmark)

    Toozs-Hobson, Philip; Al-Singary, Waleed; Fynes, Michelle;

    2012-01-01

    Polyacrylamide hydrogel (PAHG, Bulkamid®) is a promising urethral bulking agent. This article presents the 2-year follow-up results of a multicenter study of PAHG injections for treating stress and stress-predominant mixed urinary incontinence....

  2. An open multicenter study to compare the efficacy of intraperitoneal insemination and intrauterine insemination following multiple follicular development as treatment for unexplained infertility

    OpenAIRE

    Ajossa, Silvia; Melis, Gian Benedetto; Cianci, Antonio; Coccia, Maria Elisabetta; Fulghesu, Anna Maria; Giuffrida, Giuseppe; Guerriero, Stefano; Lanzone, Antonio; Francoscarselli, Gian

    1997-01-01

    Purpose: This multicenter study was carried out to compare the efficacy of intrauterine insemination (IUI) and intraperitoneal insemination (IPI) associated with multiple follicular development as treatment for unexplained infertility.

  3. Quality Control Measures over 30 Years in a Multicenter Clinical Study: Results from the Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC Study.

    Directory of Open Access Journals (Sweden)

    Gayle M Lorenzi

    Full Text Available Implementation of multicenter and/or longitudinal studies requires an effective quality assurance program to identify trends, data inconsistencies and process variability of results over time. The Diabetes Control and Complications Trial (DCCT and the follow-up Epidemiology of Diabetes Interventions and Complications (EDIC study represent over 30 years of data collection among a cohort of participants across 27 clinical centers. The quality assurance plan is overseen by the Data Coordinating Center and is implemented across the clinical centers and central reading units. Each central unit incorporates specific DCCT/EDIC quality monitoring activities into their routine quality assurance plan. The results are reviewed by a data quality assurance committee whose function is to identify variances in quality that may impact study results from the central units as well as within and across clinical centers, and to recommend implementation of corrective procedures when necessary. Over the 30-year period, changes to the methods, equipment, or clinical procedures have been required to keep procedures current and ensure continued collection of scientifically valid and clinically relevant results. Pilot testing to compare historic processes with contemporary alternatives is performed and comparability is validated prior to incorporation of new procedures into the study. Details of the quality assurance plan across and within the clinical and central reading units are described, and quality outcomes for core measures analyzed by the central reading units (e.g. biochemical samples, fundus photographs, ECGs are presented.

  4. Efficacy and safety of treatment with human insulin analogues in daily management of insulin naive patients with type 2 diabetes mellitus: results of multicenter 52-week observational study A1chive

    Directory of Open Access Journals (Sweden)

    Marina Vladimirovna Shestakova

    2012-12-01

    Full Text Available Modern insulin analogues allow safe improvement of glycemic control (not accompanied with increase in body mass or rate of severe hypoglycemic events and its efficient maintenance during long period of time. In this paper we present results of multicenter 52-week prospective observational study A1chive (Russian cohort, n=9342, designed to assess safety and efficacy of treatment with human insulin analogues (Levemir®, NovoMix® 30 and NovoRapid® (Novo Nordisk in daily management of insulin naive patients with type 2 diabetes mellitus. Prescription of human insulin analogues resulted in clinically and statistically significant improvement of glycemic control irrespective of initial insulin regimen. Therapy by various regimens (Levemir®, NovoMix® 30 or Levemir® + NovoRapid® under conditions of daily clinical practice leads to marked improvement in glycemic control as measured by HbA1c (-2.9% in 12 month with no evidence for negative influence on tolerability and short-term safety of the treatment. Furthermore, decrease in HbA1c levels was associated with pronounced and stable decrease in fasting and postprandial glucose levels (-5.0 mmol/L and -5.7 mmol/L, respectively. By the end of the follow-up all regimen groups reported improvement of QoL by treatment satisfaction criterion.

  5. Establishment of a regional multicenter traumatic spine fracture/dislocation registry

    Institute of Scientific and Technical Information of China (English)

    Vafa Rahimi-Movaghar; Soheil Saadat; Saba Jafarpour

    2014-01-01

    Objective:Trauma is one of the leading causes of mortality and morbidity in adults and a major contributor to health care expenditures.Although spine-related injuries constitute a small proportion of trauma cases,they need special consideration due to poor functional outcomes and substantial burden.Despite relatively extensive previous studies on traumatic spinal injuries,there is still obscurity in some aspects of the issue.The purpose of this study is to establish a regional multicenter traumatic spine fracture/dislocation registry.Methods:This is a prospective case series study,including all patients with acute traumatic spine lesions admitted to a regional multicenter since 2014.Data is extracted based upon a form developed by Sina Trauma and Surgery Research Center,Tehran University of Medical Sciences,Tehran,Iran.Novel electronic data entry software is initiated and data will be entered to the software.Information remains confidential and security considerations will be taken based on standards of data entry systems.Results:The results of this study will include age and gender distribution of the patients,causes of injury,location of pain and neurological deficit,the American Spinal Injury Association score and Frankel grade on admission,at discharge,after 6 and 12 months and at the latest annual follow-up,radiologic findings,details of operative procedures and methods of external fixation.Conclusion:This study will identify prognostic factors that influence the ultimate fate of spine fracture patients and determine short and long-term outcome of different treatment methods.It can lead to a considerable improvement in patient care and will have a great national and transnational impact.

  6. Prospective cohort study of febrile neutropenia in breast cancer patients with neoadjuvant and adjuvant chemotherapy: CSPOR-BC FN study.

    Science.gov (United States)

    Ishikawa, Takashi; Sakamaki, Kentaro; Narui, Kazutaka; Kaise, Hiroshi; Tsugawa, Koichiro; Ichikawa, Yasushi; Mukai, Hirofumi

    2016-07-01

    With the increasing use of adjuvant chemotherapy for treating early breast cancer, febrile neutropenia management has become crucial. Guidelines for febrile neutropenia management are mostly based on a Caucasian population survey although ethnic differences are reported in terms of adverse events. We survey the current status of febrile neutropenia and risk factors in Japanese female breast cancer patients receiving neoadjuvant and adjuvant chemotherapy regimens potential for febrile neutropenia. Subsequently, we plan to conduct a multicenter prospective cohort study involving 1000 patients with operable breast cancer. With the current state of oral antibiotics being routinely prescribed without hematology tests, we survey febrile neutropenia based on two different definitions, namely, true febrile neutropenia: ≥37.5°C and Grade 4 neutropenia, and surrogate febrile neutropenia: ≥37.5°C and oral antibiotic and antipyretic intake. The comparison of true febrile neutropenia and surrogate febrile neutropenia incidences is anticipated to provide information on the safety and feasibility of chemotherapy management without performing blood tests. PMID:27162322

  7. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

    OpenAIRE

    Eisenstein, Eric L.; Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2010-01-01

    New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators ...

  8. The use of new technologies in Cohort studies

    Directory of Open Access Journals (Sweden)

    Carlos Antonio Bruno da Silva

    2010-03-01

    estudosepidemiológicos: conceitos básicos e aplicaçõesna área do envelhecimento. Epidemiol Serv Saúde.2003;12(3:189-201.10. Muñoz A, Schrager LK, Bacellar H, et al. Trendsin the incidence of outcomes defining acquiredimmunodeficiency syndrome (AIDS in the MulticenterAIDS Cohort Study: 1985-1991. Am J Epidemiol.1993;137:423-38.11. Tager IB. Outcomes in cohort studies. Epidemiol Rev.1998;20(1:15-28.12. Moura KS, Bessa OAACB, Nuto SAS, Sá HLC, VerasFMF, Braga JU. Projeto Coorte dendê: diagnosticodemográfico e condições de moradia de umacomunidade de baixa renda em Fortaleza- Ceará. RevBras Promoção Saúde. 2010;23(1:17-23.13. Preis SR, Massaro JM, Hoffmann U, D’Agostino RBSr, Levy D, Robins SJ, et al. Neck Circumferenceas a Novel Measure of Cardiometabolic Risk: TheFramingham Heart Study. J Clin Endocrinol Metab.2010 May 19. [Epub ahead of print].14. Zomer E, Owen A, Magliano DJ, Liew D, Reid C.Validation of two Framingham cardiovascular riskprediction algorithms in an Australian population: the‘old’ versus the ‘new’ Framingham equation. Eur JCardiovasc Prev Rehabil. 2010 May 13. [Epub aheadof print

  9. Period effects, cohort effects, and the narrowing gender wage gap.

    Science.gov (United States)

    Campbell, Colin; Pearlman, Jessica

    2013-11-01

    Despite the abundance of sociological research on the gender wage gap, questions remain. In particular, the role of cohorts is under investigated. Using data from the Current Population Survey, we use age-period-cohort analysis to uniquely estimate age, period, and cohort effects on the gender wage gap. The narrowing of the gender wage gap that occurred between 1975 and 2009 is largely due to cohort effects. Since the mid-1990s, the gender wage gap has continued to close absent of period effects. While gains in female wages contributed to declines in the gender wage gap for cohorts born before 1950, for later cohorts the narrowing of the gender wage gap is primarily a result of declines in male wages. PMID:24090861

  10. On the correspondence between CAL and lagged cohort life expectancy

    OpenAIRE

    Michel Guillot; Hyun Sik Kim

    2011-01-01

    It has been established that under certain mortality assumptions, the current value of the Cross-sectional Average length of Life (CAL) is equal to the life expectancy for the cohort currently reaching its life expectancy. This correspondence is important, because the life expectancy for the cohort currently reaching its life expectancy, or lagged cohort life expectancy (LCLE), has been discussed in the tempo literature as a summary mortality measure of substantive interest. In this paper, we...

  11. Tinned Fruit Consumption and Mortality in Three Prospective Cohorts

    OpenAIRE

    Aasheim, Erlend T.; Sharp, Stephen J.; Appleby, Paul N.; Shipley, Martin J.; Lentjes, Marleen A.H.; Kay-Tee Khaw; Eric Brunner; Key, Tim J.; Wareham, Nicholas J

    2015-01-01

    Dietary recommendations to promote health include fresh, frozen and tinned fruit, but few studies have examined the health benefits of tinned fruit. We therefore studied the association between tinned fruit consumption and mortality. We followed up participants from three prospective cohorts in the United Kingdom: 22,421 participants from the European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk cohort (1993-2012), 52,625 participants from the EPIC-Oxford cohort (1993-20...

  12. Cohort Effects and Returns to Seniority in France

    OpenAIRE

    Margolis, David N.

    1995-01-01

    We examine empirically returns to seniority in France and estimate cohort effects in both firm specific compensation policies and returns to job seniority. We demonstrate the biases in several estimators of returns to seniority and show that allowing firm specific compensation policies and returns to seniority to vary by entry cohort uncovers patterns of variance within firm and within cohort in estimated intercepts and slopes that can be explained by no single theory.

  13. Distribution of guidance models for cardiac resynchronization therapy in the setting of multi-center clinical trials

    Science.gov (United States)

    Rajchl, Martin; Abhari, Kamyar; Stirrat, John; Ukwatta, Eranga; Cantor, Diego; Li, Feng P.; Peters, Terry M.; White, James A.

    2014-03-01

    Multi-center trials provide the unique ability to investigate novel techniques across a range of geographical sites with sufficient statistical power, the inclusion of multiple operators determining feasibility under a wider array of clinical environments and work-flows. For this purpose, we introduce a new means of distributing pre-procedural cardiac models for image-guided interventions across a large scale multi-center trial. In this method, a single core facility is responsible for image processing, employing a novel web-based interface for model visualization and distribution. The requirements for such an interface, being WebGL-based, are minimal and well within the realms of accessibility for participating centers. We then demonstrate the accuracy of our approach using a single-center pacemaker lead implantation trial with generic planning models.

  14. AGRICOH: A Consortium of Agricultural Cohorts

    Directory of Open Access Journals (Sweden)

    Shelia H. Zahm

    2011-04-01

    Full Text Available AGRICOH is a recently formed consortium of agricultural cohort studies involving 22 cohorts from nine countries in five continents: South Africa (1, Canada (3, Costa Rica (2, USA (6, Republic of Korea (1, New Zealand (2, Denmark (1, France (3 and Norway (3. The aim of AGRICOH, initiated by the US National Cancer Institute (NCI and coordinated by the International Agency for Research on Cancer (IARC, is to promote and sustain collaboration and pooling of data to investigate the association between a wide range of agricultural exposures and a wide range of health outcomes, with a particular focus on associations that cannot easily be addressed in individual studies because of rare exposures (e.g., use of infrequently applied chemicals or relatively rare outcomes (e.g., certain types of cancer, neurologic and auto-immune diseases. To facilitate future projects the need for data harmonization of selected variables is required and is underway. Altogether, AGRICOH provides excellent opportunities for studying cancer, respiratory, neurologic, and auto-immune diseases as well as reproductive and allergic disorders, injuries and overall mortality in association with a wide array of exposures, prominent among these the application of pesticides.

  15. Cohort study of atypical pressure ulcers development.

    Science.gov (United States)

    Jaul, Efraim

    2014-12-01

    Atypical pressure ulcers (APU) are distinguished from common pressure ulcers (PU) with both unusual location and different aetiology. The occurrence and attempts to characterise APU remain unrecognised. The purpose of this cohort study was to analyse the occurrence of atypical location and the circumstances of the causation, and draw attention to the prevention and treatment by a multidisciplinary team. The cohort study spanned three and a half years totalling 174 patients. The unit incorporates two weekly combined staff meetings. One concentrates on wound assessment with treatment decisions made by the physician and nurse, and the other, a multidisciplinary team reviewing all patients and coordinating treatment. The main finding of this study identified APU occurrence rate of 21% within acquired PU over a three and a half year period. Severe spasticity constituted the largest group in this study and the most difficult to cure wounds, located in medial aspects of knees, elbows and palms. Medical devices caused the second largest occurrence of atypical wounds, located in the nape of the neck, penis and nostrils. Bony deformities were the third recognisable atypical wound group located in shoulder blades and upper spine. These three categories are definable and time observable. APU are important to be recognisable, and can be healed as well as being prevented. The prominent role of the multidisciplinary team is primary in identification, prevention and treatment. PMID:23374746

  16. Adult outcomes of teen mothers across birth cohorts

    Directory of Open Access Journals (Sweden)

    Anne Driscoll

    2014-04-01

    Full Text Available Background: Teen and young adult mothers have lower socioeconomic status than older mothers. Objective: This study analyzes the socioeconomic status (SES of teen, young adult, and older adult mothers across four five-year birth cohorts from 1956 to 1975 who were teens from 1971 to 1994. Methods: Data were pooled from the 1995, 2002, and 2006-2010 National Survey of Family Growth (NSFG. Mothers were categorized by age at first birth and by their birth cohorts. The SES (education, single motherhood, poverty, employment of teen, young adult, and older mothers was compared across cohorts and within cohorts. Results: Among teen mothers, the odds of fulltime employment improved across birth cohorts and the odds of educational attainment beyond high school did not vary. Their odds of single motherhood and living in poverty increased across cohorts. The odds of higher education and single motherhood increased across birth cohorts for young adult mothers as did the odds of living in poverty, even if working fulltime. Among older adult mothers, educational attainment and the odds of single motherhood rose for recent cohorts. Conclusions: Comparisons between teen mothers and both young adult and all adult mothers within cohorts suggest that gaps in single motherhood and poverty between teen and adult mothers have widened over time, to the detriment of teen mothers. Teen mothers have become more likely to be single and poor than in the past and compared to older mothers.

  17. Period Effects, Cohort Effects, and the Narrowing Gender Wage Gap

    OpenAIRE

    Campbell, Colin; Pearlman, Jessica

    2013-01-01

    Despite the abundance of sociological research on the gender wage gap, questions remain. In particular, the role of cohorts is under investigated. Using data from the Current Population Survey, we use Age-Period-Cohort analysis to uniquely estimate age, period, and cohort effects on the gender wage gap. The narrowing of the gender wage gap that occurred between 1975 and 2009 is largely due to cohort effects. Since the mid-1990s, the gender wage gap has continued to close absent of period effe...

  18. Prevalence and type distribution of human papillomavirus among women older than 18 years in Egypt: a multicenter, observational study

    OpenAIRE

    Mohamed Fadel Shaltout; Sallam, Hassan N.; Maged AbouSeeda; Fady Moiety; Hossam Hemeda; Ahmed Ibrahim; Moutaz E.L. Sherbini; Helmy Rady; Kusuma Gopala; Rodrigo DeAntonio

    2014-01-01

    Objectives: Persistent infection with high-risk (HR) human papillomavirus (HPV) is associated with premalignant lesions and cervical cancer, the third most common cancer amongst women globally and the second most frequent in Egypt. We studied the prevalence and type distribution of HPV and documented HPV infection awareness and health-related behaviours for HPV infection. Methods: This was a multicenter, hospital-based observational study of women ≥18 years of age who attended for a gynaec...

  19. A multicenter evaluation of a new antibody test kit for lymphatic filariasis employing recombinant Brugia malayi antigen Bm-14

    OpenAIRE

    Weil, Gary J; Curtis, Kurt C.; Fischer, Peter U.; Kimberly Y Won; Lammie, Patrick J; Joseph, Hayley; Melrose, Wayne D; Brattig, Norbert W.

    2010-01-01

    Antibody tests are useful for mapping the distribution of lymphatic filariasis (LF) in countries and regions and for monitoring progress in elimination programs based on mass drug administration (MDA). Prior antibody tests have suffered from poor sensitivity and/or specificity or from a lack of standardization. We conducted a multicenter evaluation of a new commercial ELISA that detects IgG4 antibodies to the recombinant filarial antigen Bm14. Four laboratories tested a shared panel of coded ...

  20. An international multicenter study on the effectiveness of a denture adhesive in maxillary dentures using disposable gnathometers

    OpenAIRE

    de Baat, Cees; van 't Hof, Martin; Van Zeghbroeck, Lieve; Özcan, Mutlu; Kalk, Warner

    2007-01-01

    No consensus has been achieved on whether denture adhesives are beneficial adjuncts in denture-wearers management. The purpose of this international multicenter study was to determine objectively the effect of a denture adhesive (Kukident) on the retention of complete maxillary dentures using disposable gnathometers. The disposable gnathometers have a decimal scale for measuring the incisal force before dislodgement (= maximum incisal force) of maxillary dentures. The intra-observer reliabili...

  1. Validation of a PCR-Oligochromatography Test for Detection of Trypanozoon Parasites in a Multicenter Collaborative Trial▿

    OpenAIRE

    Claes, F.; Deborggraeve, S.; Verloo, D.; Mertens, P.; Crowther, J. R.; Leclipteux, T.; Büscher, P.

    2007-01-01

    A PCR-oligochromatography test for diagnosis of human and animal trypanosomiasis was evaluated through a multicenter ring trial with six laboratories testing a set of 21 blinded samples, resulting in qualitative data (positive or negative). Results showed an intralaboratory repeatability (accordance) of 88.7% (credible interval [CI], 84.4 to 92.5%) and an interlaboratory repeatability (concordance) of 88.1% (CI, 84.3 to 92.3%).

  2. Levels of Protein C and Soluble Thrombomodulin in Critically Ill Patients with Acute Kidney Injury: A Multicenter Prospective Observational Study

    OpenAIRE

    Josée Bouchard; Rakesh Malhotra; Shamik Shah; Yu-Ting Kao; Florin Vaida; Akanksha Gupta; Berg, David T.; Grinnell, Brian W.; Brenda Stofan; Tolwani, Ashita J.; Mehta, Ravindra L

    2015-01-01

    Endothelial dysfunction contributes to the development of acute kidney injury (AKI) in animal models of ischemia reperfusion injury and sepsis. There are limited data on markers of endothelial dysfunction in human AKI. We hypothesized that Protein C (PC) and soluble thrombomodulin (sTM) levels could predict AKI. We conducted a multicenter prospective study in 80 patients to assess the relationship of PC and sTM levels to AKI, defined by the AKIN creatinine (AKI Scr) and urine output criteria ...

  3. Correlates of HIV, HBV, HCV and syphilis infections among prison inmates and officers in Ghana: A national multicenter study

    OpenAIRE

    Asare Isaac; Adu-Gyamfi Clement; Boamah Isaac; Ampofo William K; Gbagbo Foster; Armah Henry B; Adjei Andrew A; Hesse Ian FA; Mensah George

    2008-01-01

    Abstract Background Prisons are known to be high-risk environments for the spread of bloodborne and sexually transmitted infections. Prison officers are considered to have an intermittent exposure potential to bloodborne infectious diseases on the job, however there has been no studies on the prevalence of these infections in prison officers in Ghana. Methods A national multicenter cross-sectional study was undertaken on correlates of human immunodeficiency virus (HIV), hepatitis B virus (HBV...

  4. Multicenter Evaluation of the Mycobacteria Growth Indicator Tube for Testing Susceptibility of Mycobacterium tuberculosis to First-Line Drugs

    OpenAIRE

    Rüsch-Gerdes, Sabine; Domehl, Cornelia; Nardi, Giampietro; Gismondo, Maria Rita; Welscher, Hans-Martin; Pfyffer, Gaby E.

    1999-01-01

    In a multicenter study involving three reference centers for mycobacteria, the reliability of the Mycobacteria Growth Indicator Tube (MGIT) for rapid antimicrobial susceptibility testing (AST) of Mycobacterium tuberculosis was evaluated and compared to the radiometric method (BACTEC 460TB). Test cultures for which the results of the MGIT and BACTEC 460TB tests were discordant were checked by the conventional proportion method on solid medium. Four hundred forty-one isolates have been tested f...

  5. Topical Administration of a Connexin43-based peptide Augments Healing of Chronic Neuropathic Diabetic Foot Ulcers: A Multicenter, Randomized Trial

    OpenAIRE

    Grek, Christina L.; Prasad, G.M.; Viswanathan, Vijay; Armstrong, David G.; Gourdie, Robert G.; Ghatnekar, Gautam S.

    2015-01-01

    Nonhealing neuropathic foot ulcers remain a significant problem in individuals with diabetes. The gap-junctional protein connexin43 (Cx43) has roles in dermal wound healing and targeting Cx43 signaling accelerates wound reepithelialization. In a prospective, randomized, multi-center clinical trial we evaluated the efficacy and safety of a peptide mimetic of the C-terminus of Cx43, ACT1, in accelerating the healing of chronic diabetic foot ulcers (DFUs) when incorporated into standard of care ...

  6. ICA-based artifact removal diminishes scan site differences in multi-center resting-state fMRI.

    OpenAIRE

    Rogier Alexander Feis; Smith, Stephen M.; Nicola eFilippini; Gwenaëlle eDouaud; Dopper, Elise G. P.; Verena eHeise; Trachtenberg, Aaron J.; van Swieten, John C.; van Buchem, Mark A; Rombouts, Serge A.R.B.; Mackay, Clare E.

    2015-01-01

    Resting-state fMRI (R-fMRI) has shown considerable promise in providing potential biomarkers for diagnosis, prognosis and drug response across a range of diseases. Incorporating R-fMRI into multi-center studies is becoming increasingly popular, imposing technical challenges on data acquisition and analysis, as fMRI data is particularly sensitive to structured noise resulting from hardware, software and environmental differences. Here, we investigated whether a novel clean up tool for structur...

  7. ICA-based artifact removal diminishes scan site differences in multi-center resting-state fMRI

    OpenAIRE

    Feis, Rogier A.; Smith, Stephen M.; Filippini, Nicola; Douaud, Gwenaëlle; Dopper, Elise G. P.; Heise, Verena; Trachtenberg, Aaron J.; van Swieten, John C.; van Buchem, Mark A; Rombouts, Serge A.R.B.; Mackay, Clare E.

    2015-01-01

    Resting-state fMRI (R-fMRI) has shown considerable promise in providing potential biomarkers for diagnosis, prognosis and drug response across a range of diseases. Incorporating R-fMRI into multi-center studies is becoming increasingly popular, imposing technical challenges on data acquisition and analysis, as fMRI data is particularly sensitive to structured noise resulting from hardware, software, and environmental differences. Here, we investigated whether a novel clean up tool for structu...

  8. Lifestyle INtervention for Diabetes prevention After pregnancy (LINDA-Brasil): study protocol for a multicenter randomized controlled trial

    OpenAIRE

    Schmidt, Maria Inês; Bruce B. Duncan; Castilhos, Cristina; Wendland, Eliana Márcia; Hallal, Pedro C; Schaan, Beatriz D’Agord; Drehmer, Michele; Costa e Forti, Adriana; Façanha, Cristina; Nunes, Maria Angélica

    2016-01-01

    Background Gestational diabetes mellitus (GDM), a hyperglycemic state detected during pregnancy, is an established risk factor for diabetes. However, treatment during pregnancy in and of itself is not able to eliminate this risk, and a considerable fraction of women with GDM will develop frank diabetes in the decade following pregnancy. Our aim is to conduct a multicenter randomized controlled trial to investigate the effectiveness of a lifestyle intervention program implemented after a pregn...

  9. The Burden of Eclampsia: Results from a Multicenter Study on Surveillance of Severe Maternal Morbidity in Brazil

    OpenAIRE

    Giordano, Juliana C.; Parpinelli, Mary A; Cecatti, Jose G.; Haddad, Samira M; Costa, Maria L; Fernanda G Surita; Joao L Pinto E Silva; Sousa, Maria H

    2014-01-01

    OBJECTIVE: Maternal mortality (MM) is a core indicator of disparities in women's rights. The study of Near Miss cases is strategic to identifying the breakdowns in obstetrical care. In absolute numbers, both MM and occurrence of eclampsia are rare events. We aim to assess the obstetric care indicators and main predictors for severe maternal outcome from eclampsia (SMO: maternal death plus maternal near miss). METHODS: Secondary analysis of a multicenter, cross-sectional study, including 27 ce...

  10. MiDas: automatic extraction of a common domain of discourse in sleep medicine for multi-center data integration.

    Science.gov (United States)

    Sahoo, Satya S; Ogbuji, Chimezie; Luo, Lingyun; Dong, Xiao; Cui, Licong; Redline, Susan S; Zhang, Guo-Qiang

    2011-01-01

    Clinical studies often use data dictionaries with controlled sets of terms to facilitate data collection, limited interoperability and sharing at a local site. Multi-center retrospective clinical studies require that these data dictionaries, originating from individual participating centers, be harmonized in preparation for the integration of the corresponding clinical research data. Domain ontologies are often used to facilitate multi-center data integration by modeling terms from data dictionaries in a logic-based language, but interoperability among domain ontologies (using automated techniques) is an unresolved issue. Although many upper-level reference ontologies have been proposed to address this challenge, our experience in integrating multi-center sleep medicine data highlights the need for an upper level ontology that models a common set of terms at multiple-levels of abstraction, which is not covered by the existing upper-level ontologies. We introduce a methodology underpinned by a Minimal Domain of Discourse (MiDas) algorithm to automatically extract a minimal common domain of discourse (upper-domain ontology) from an existing domain ontology. Using the Multi-Modality, Multi-Resource Environment for Physiological and Clinical Research (Physio-MIMI) multi-center project in sleep medicine as a use case, we demonstrate the use of MiDas in extracting a minimal domain of discourse for sleep medicine, from Physio-MIMI's Sleep Domain Ontology (SDO). We then extend the resulting domain of discourse with terms from the data dictionary of the Sleep Heart and Health Study (SHHS) to validate MiDas. To illustrate the wider applicability of MiDas, we automatically extract the respective domains of discourse from 6 sample domain ontologies from the National Center for Biomedical Ontologies (NCBO) and the OBO Foundry. PMID:22195180

  11. High protein intake is associated with low prevalence of frailty among old Japanese women: a multicenter cross-sectional study

    OpenAIRE

    Kobayashi, Satomi; Asakura, Keiko; Suga, Hitomi; Sasaki, Satoshi

    2013-01-01

    Background Protein intake has been inversely associated with frailty. However, no study has examined the effect of the difference of protein sources (animal or plant) or the amino acid composing the protein on frailty. Therefore, we examined the association of protein and amino acid intakes with frailty among elderly Japanese women. Methods A total of 2108 grandmothers or acquaintances of dietetic students aged 65 years and older participated in this cross-sectional multicenter study, which w...

  12. Assessment of mRNA and microRNA Stabilization in Peripheral Human Blood for Multicenter Studies and Biobanks

    OpenAIRE

    Beate Pesch; Heinz Otten; Michaela Kreuzer; Maria Gomolka; Dirk Taeger; Oleksandr Bryk; Sandra Zilch- Schöneweis; Peter Rozynek; Martin Lehnert; Swaantje Casjens; Daniel Gilbert Weber; Georg Johnen; Thomas Brüning

    2010-01-01

    In this study we evaluate the suitability of two methods of RNA conservation in blood samples, PAXgene and RNAlater, in combination with variable shipping conditions for their application in multicenter studies and biobanking. RNA yield, integrity, and purity as well as levels of selected mRNA and microRNA species were analyzed in peripheral human blood samples stabilized by PAXgene or RNAlater and shipped on dry ice or at ambient temperatures from the study centers to the central analysis la...

  13. Acute Kidney Injury in Severe Sepsis and Septic Shock in Patients with and without Diabetes Mellitus: A Multicenter Study

    OpenAIRE

    Venot, Marion; Weis, Lise; Clec’h, Christophe; Darmon, Michael; Allaouchiche, Bernard; Goldgran-Tolédano, Dany; Garrouste-Orgeas, Maité; Adrie, Christophe; Timsit, Jean-François; Azoulay, Elie

    2015-01-01

    Introduction Whether diabetes mellitus increases the risk of acute kidney injury (AKI) during sepsis is controversial. Materials and Methods We used a case-control design to compare the frequency of AKI, use of renal replacement therapy (RRT), and renal recovery in patients who had severe sepsis or septic shock with or without diabetes. The data were from the Outcomerea prospective multicenter database, in which 12 French ICUs enrolled patients admitted between January 1997 and June 2009. Res...

  14. Clostridium difficile infection after adult autologous stem cell transplantation: A multicenter study of epidemiology and risk factors

    OpenAIRE

    Alonso, Carolyn D.; Dufresne, Simon F.; Hanna, David B.; Labbé, Annie-Claude; Treadway, Suzanne B.; Neofytos, Dionissios; Bélanger, Sylvie; Huff, Carol Ann; Laverdière, Michel; Marr, Kieren A.

    2013-01-01

    We sought to describe the epidemiology of Clostridium difficile infection (CDI) among adult recipients of autologous hematopoietic stem cell transplantation (auto HSCT) within the first year after HSCT in centers with variable epidemiology of hyper-toxigenic strains. A multicenter, retrospective nested case-control study was conducted among 873 auto HSCT recipients at Johns Hopkins Hospital (JHH, Baltimore, MD) and Hôpital Maisonneuve-Rosemont (HMR, Montreal, Canada) between 1/2003-12/2008. D...

  15. Sentinel node biopsy in head and neck squamous cell cancer: 5-year follow-up of a European multicenter trial

    DEFF Research Database (Denmark)

    Alkureishi, Lee W T; Ross, Gary L; Shoaib, Taimur; Soutar, David S; Robertson, A Gerry; Thompson, Richard; Hunter, Keith D; Sørensen, Jens Ahm; Thomsen, Jørn Bo; Krogdahl, Annelise; Alvarez, Julio; Barbier, Luis; Santamaria, Joseba; Poli, Tito; Sesenna, Enrico; Kovács, Adorjan F; Grünwald, Frank; Barzan, Luigi; Sulfaro, Sandro; Alberti, Franco

    2010-01-01

    Sentinel node biopsy (SNB) may represent an alternative to elective neck dissection for the staging of patients with early head and neck squamous cell carcinoma (HNSCC). To date, the technique has been successfully described in a number of small single-institution studies. This report describes t...... long-term follow-up of a large European multicenter trial evaluating the accuracy of the technique....

  16. [Snow board accidents. Multicenter Swiss snow board study 1992/93 with the cooperation of the bfu].

    Science.gov (United States)

    Campell, L; Soklic, P; Ziegler, W; Matter, P; Fenner, A; Noesberger, B; Rigo, M

    1993-01-01

    Snowboarding has become increasingly popular in recent years. A prospective multicenter study was therefore performed during the winter 1992/93. 345 injuries were analysed and compared with 305 healthy snowboarders on the slopes. Preliminary results show predominantly injuries of the upper extremity comparative to those suffered from alpine skiing. Protection of the hand and wrist is recommended as well as an instruction for a special technique for falling as measurements for accident prevention. PMID:8123341

  17. Ocular Adnexal Diffuse Large B-cell LymphomaA Multicenter International Study

    DEFF Research Database (Denmark)

    Munch-Petersen, Helga D; Rasmussen, Peter K; Coupland, Sarah E;

    2015-01-01

    IMPORTANCE: The clinical features of diffuse large B-cell lymphoma (DLBCL) subtype of ocular adnexal lymphoma have not previously been evaluated in a large cohort to our knowledge. OBJECTIVE: To investigate the clinical features of ocular adnexal DLBCL (OA-DLBCL). DESIGN, SETTING, AND PARTICIPANT...

  18. Ganirelix for luteolysis in poor responder patients undergoing IVF treatment: a Scandinavian multicenter 'extended pilot study'

    DEFF Research Database (Denmark)

    Nilsson, Lena; Andersen, A.N.; Lindenberg, Svend; Hausken, J.; Andersen, C.Y.; Kahn, J.A.

    2010-01-01

    To enhance oocyte yield and pregnancy outcome in poor responder women undergoing IVF treatment, daily low dose GnRH antagonist administration was given during the late luteal phase to induce luteolysis and possibly secure a more synchronous cohort of recruitable follicles. An open extended pilot...

  19. Comparison of comorbidities of the Egyptian rheumatoid arthritis patients to the global cohort of the COMORA study: a post-hoc analysis.

    Science.gov (United States)

    El-Zorkany, Bassel; Mokbel, Abir; Gamal, Sherif M; Mousa, Maha; Youssef, Mohamed; Hmamouchi, Ihsane

    2016-05-01

    The aims of this study are to present the results of Egyptian RA patients included in COMORA cohort and compare it to general COMORA cohort, concerning prevalence of comorbidities, and level of application of recommendations related to detection/prevention of comorbidities. Three-hundred eight Egyptian RA patients included in the cross-sectional, observational, multi-center, international study "COMORA", were compared to the total number of 3612 RA patients. The CRF of COMORA was used in all patients. CRF collects demographic and disease characteristics, comorbidities, risk factors, and compliance with recommendations regarding management of comorbidities. Data were analyzed according to COMORA protocol. Egyptian RA patients were significantly younger, had more active disease, and were more functionally disabled. They showed more frequent use of NSAIDs, methotrexate and steroids and significantly lower use of bDMARDs when compared to non-Egyptians. Egyptian patients had the highest ever HCV prevalence, while depression, hypertension, smoking and dyslipidemia were less prevalent in Egyptians. Prevalence of malignancy risk factors was highly deficient among Egyptians; primarily due to lack of screening. Further, following recommendations for monitoring comorbidities is significantly deficient among Egyptian patients. Egyptian patients had more active disease and more functional impairment than the rest of the COMORA cohort; with lower use of bDMARDs, that is possibly related to the economic situation. Also, there is a clear gap in screening and monitoring comorbidities. Awareness among Egyptian healthcare providers (and possibly similar third-world countries) to detect and manage RA-related comorbidities is required. PMID:26670453

  20. Nosocomial acquisition of methicillin-resistant Staphyloccocus aureus (MRSA and extended-spectrum beta-lactamase (ESBL Enterobacteriaceae in hospitalised patients: a prospective multicenter study

    Directory of Open Access Journals (Sweden)

    De Angelis Giulia

    2012-03-01

    Full Text Available Abstract Background The risk of acquisition of antibiotic resistant-bacteria during or shortly after antibiotic therapy is still unclear and it is often confounded by scarce data on antibiotic usage. Primary objective of the study is to compare rates of acquisition of methicillin-resistant Staphylococcus aureus and extended spectrum beta-lactamase-producing Enterobacteriaceae in hospitalised patients, after starting antibiotic therapy. Methods/Design The study, running in three European hospitals, is a multicenter, prospective, longitudinal, observational cohort study funded from the European Community's Seventh Framework Programme [FP7/2007-2013] within the project 'Impact of Specific Antibiotic Therapies on the prevalence of hUman host ResistaNt bacteria' (acronym SATURN. Nasal and rectal screening for methicillin-resistant Staphylococcus aureus and extended spectrum beta-lactamase-producing Enterobacteriaceae will be obtained at hospital admission, discharge, at antibiotic start (t0, within one hour and at the following intervals: day 3 (t1, 7 (t2, 15 (t3, and 30 (t4. Two nested case-control studies will be performed. The objective of the first study will be to define individual level of risk related to specific antibiotics. Patients acquiring methicillin-resistant Staphylococcus aureus and extended spectrum beta-lactamase-producing Enterobacteriaceae (cases will be compared with patients not acquiring antibiotic-resistant strains after starting antibiotic therapy (controls; ratio 1:4. To define the impact of antibiotics on new acquisition of target antibiotic-resistant bacteria, a second nested case-control study will be done (ratio 1:4. Control group will be selected among patients not receiving antibiotics, admitted in the same ward on the day of the corresponding case, with negative cultures at admission. Epidemiological, clinical and microbiological data will be prospective collected. Discussion The rationale of this study is to better

  1. The Efficacy and Safety of Wenxin Keli in Patients with Frequent Premature Ventricular Contractions: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial

    Institute of Scientific and Technical Information of China (English)

    Wei Hua; Run-Lin Gao; Bu-Chang Zhao; Jing Wang; Xu-Hua Chen; Chi Cai; Shu Zhang

    2015-01-01

    Background:Premature ventricular contractions (PVCs) are common in the general population,and frequent PVCs may result in the poor quality of life or even the damage of cardiac function.We examined the efficacy and safety of a traditional Chinese medicine Wenxin Keli for the treatment of frequent PVCs among a relatively large Chinese cohort.Methods:We performed a randomized,double-blind,placebo-controlled,parallel-group,multicenter trial.A total of 1200 eligible participants were randomly assigned in a ratio of 1:1 to receive Wenxin Keli or the placebo for 4 weeks.The primary and secondary endpoint was the change of PVC numbers and PVC-related symptoms after a 4-week treatment compared with baseline,respectively.In addition,vital signs,laboratory values,and electrocardiographic parameters were assessed in a safety analysis.Results:At the initial evaluation,no significant differences in the baseline characteristics were observed between the Wenxin Keli group and the placebo group.A smaller number of PVCs was observed after the 4-week treatment than at baseline,in both the Wenxin Keli group (5686 ± 5940 vs.15,138 ± 7597 beats/d,P < 0.001) and the placebo group (10,592 ± 8009 vs.14,529 ± 5929 beats/d,P < 0.001);moreover,the Wenxin Keli group demonstrated a significantly greater reduction in the frequency of PVCs than the placebo group (P < 0.001).In a full analysis set,patients in the Wenxin Keli group exhibited significantly higher total effective responses in the reduction of PVCs compared to those in the placebo group (83.8% vs.43.5%,P < 0.001).The per-protocol analysis yielded similar results (83.0% vs.39.3%,P < 0.001).Treatment with Wenxin Keli also demonstrated superior performance compared to the placebo with respect to PVC-related symptoms.No severe adverse effects attributable to Wenxin Keli were reported.Conclusions:Wenxin Keli treatment effectively reduced the overall number of PVCs and alleviated PVC-related symptoms in patients

  2. Paclitaxel injection concentrate for nanodispersion versus nab-paclitaxel in women with metastatic breast cancer: a multicenter, randomized, comparative phase II/III study.

    Science.gov (United States)

    Jain, Minish M; Gupte, Smita U; Patil, Shekhar G; Pathak, Anand B; Deshmukh, Chetan D; Bhatt, Niraj; Haritha, Chiramana; Govind Babu, K; Bondarde, Shailesh A; Digumarti, Raghunadharao; Bajpai, Jyoti; Kumar, Ravi; Bakshi, Ashish V; Bhattacharya, Gouri Sankar; Patil, Poonam; Subramanian, Sundaram; Vaid, Ashok K; Desai, Chirag J; Khopade, Ajay; Chimote, Geetanjali; Bapsy, Poonamalle P; Bhowmik, Shravanti

    2016-02-01

    Paclitaxel is widely used in the treatment of patients with metastatic breast cancer (MBC). Formulations of paclitaxel contain surfactants and solvents or albumin derived from human blood. The use of co-solvents such as polyoxyethylated castor oil is thought to contribute to toxicity profile and hypersensitivity reactions as well as leaching of plasticizers from polyvinyl chloride bags and infusion sets. Currently, nab-paclitaxel, an albumin-bound paclitaxel in nanometer range continues to be the preferred taxane formulation used in clinic. This study (CTRI/2010/091/001116) investigated the efficacy and tolerability of a polyoxyethylated castor oil- and albumin-free formulation of paclitaxel [paclitaxel injection concentrate for nanodispersion (PICN)] compared with nab-paclitaxel in women with refractory MBC. The current study was a multicenter, open-label, parallel-group, randomized, comparative phase II/III trial evaluating the efficacy and safety of PICN (260 mg/m(2) [n = 64] and 295 mg/m(2) [n = 58] every 3 weeks) compared with nab-paclitaxel (260 mg/m(2) every 3 weeks [n = 58]) in women 18 and 70 years old with confirmed MBC. Overall response rate (ORR) was assessed with imaging every 2 cycles. An independent analysis of radiologic data was performed for evaluable patients. Progression-free survival (PFS) was a secondary efficacy measure. Independent radiologist-assessed ORRs in the evaluable population of women aged ≥70 years were 35, 49, and 43 % in the PICN 260 mg/m(2), PICN 295 mg/m(2), and nab-paclitaxel 260 mg/m(2) arms, respectively. Median PFS in the evaluable population was 23, 35, and 34 weeks in the PICN 260 mg/m(2), PICN 295 mg/m(2), and nab-paclitaxel 260 mg/m(2) arms, respectively. Adverse events occurred in similar proportions of patients across treatment arms. Hypersensitivity reactions were not frequently observed with the clinical use of PICN across the treatment cohorts. In women with metastatic breast cancer, PICN at 260 and 295 mg/m(2

  3. Traditional invasive vs. minimally invasive esophagectomy: a multi-center, randomized trial (TIME-trial

    Directory of Open Access Journals (Sweden)

    de Lange Elly SM

    2011-01-01

    Full Text Available Abstract Background There is a rise in incidence of esophageal carcinoma due to increasing incidence of adenocarcinoma. Probably the only curative option to date is the use of neoadjuvant therapy followed by surgical resection. Traditional open esophageal resection is associated with a high morbidity and mortality rate. Furthermore, this approach involves long intensive care unit stay, in-hospital stay and long recovery period. Minimally invasive esophagectomy could reduce the morbidity and accelerate the post-operative recovery. Methods/Design Comparison between traditional open and minimally invasive esophagectomy in a multi-center, randomized trial. Patients with a resectable intrathoracic esophageal carcinoma, including the gastro-esophageal junction tumors (Siewert I are eligible for inclusion. Prior thoracic surgery and cervical esophageal carcinoma are indications for exclusion. The surgical technique involves a right thoracotomy with lung blockade and laparotomy either with a cervical or thoracic anastomosis for the traditional group. The minimally invasive procedure involves a right thoracoscopy in prone position with a single lumen tube and laparoscopy either with a cervical or thoracic anastomosis. All patients in both groups will undergo identical pre-operative and post-operative protocol. Primary endpoint of this study are post-operative respiratory complications within the first two post-operative weeks confirmed by clinical, radiological and sputum culture data. Secondary endpoints are the operative data, the post-operative data and oncological data such as quality of the specimen and survival. Operative data include duration of the operation, blood loss and conversion to open procedure. Post-operative data include morbidity (major and minor, quality of life tests and hospital stay. Based on current literature and the experience of all participating centers, an incidence of pulmonary complications for 57% in the traditional arm

  4. Outcome and patterns of failure in testicular lymphoma: a multicenter rare cancer network study

    International Nuclear Information System (INIS)

    Purpose: To assess the outcome and patterns of failure in patients with testicular lymphoma treated by chemotherapy (CT) and/or radiation therapy (RT). Methods and Materials: Data from a series of 36 adult patients with Ann Arbor Stage I (n=21), II (n=9), III (n=3), or IV (n=3) primary testicular lymphoma, consecutively treated between 1980 and 1999, were collected in a retrospective multicenter study by the Rare Cancer Network. Median age was 64 years (range: 21-91 years). Full staging workup (chest X-ray, testicular ultrasound, abdominal ultrasound, and/or thoracoabdominal computer tomography, bone marrow assessment, full blood count, lactate dehydrogenase, and cerebrospinal fluid evaluation) was completed in 18 (50%) patients. All but one patient underwent orchidectomy, and spermatic cord infiltration was found in 9 patients. Most patients (n=29) had CT, consisting in most cases of cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) with (n=17) or without intrathecal CT. External RT was delivered to scrotum alone (n=12) or testicular, iliac, and para-aortic regions (n=8). The median RT dose was 31 Gy (range: 20-44 Gy) in a median of 17 fractions (10-24), using a median of 1.8 Gy (range: 1.5-2.5 Gy) per fraction. The median follow-up period was 42 months (range: 6-138 months). Results: After a median period of 11 months (range: 1-76 months), 14 patients presented lymphoma progression, mostly in the central nervous system (CNS) (n=8). Among the 17 patients who received intrathecal CT, 4 had a CNS relapse (p=NS). No testicular, iliac, or para-aortic relapse was observed in patients receiving RT to these regions. The 5-year overall, lymphoma-specific, and disease-free survival was 47%, 66%, and 43%, respectively. In univariate analyses, statistically significant factors favorably influencing the outcome were early-stage and combined modality treatment. Neither RT technique nor total dose influenced the outcome. Multivariate analysis revealed that the

  5. DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative Treatment. A MULTICENTER RANDOMISED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    van de Wall Bryan JM

    2010-08-01

    Full Text Available Abstract Background Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses. Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management. We, therefore, constructed a randomised clinical trial comparing these two treatment strategies. Methods/design The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management. Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used. The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years. Discussion Considering the high incidence and the

  6. On Aggregating Human Capital Across Heterogeneous Cohorts

    DEFF Research Database (Denmark)

    Growiec, Jakub; Groth, Christian

    Based on a general framework for computing the aggregate human capital stock under heterogeneity across population cohorts, the paper derives aggregate human capital stocks in the whole population and in the labor force, and relates these variables to average years of schooling and average work...... experience. Under the scenarios considered here, the "macro-Mincer" (log-linear) relationship between aggregate human capital and average years of schooling is obtained only in cases which are inconsistent with heterogeneity in years of schooling and based on empirically implausible demographic survival laws....... Our numerical results indicate that the macro-Mincer equation can be a reasonable approximation of the true relationship only if returns to schooling and work experience are roughly constant across countries...

  7. Building the Future with Cohorts: Communities of Inquiry

    Science.gov (United States)

    Rausch, David W.; Crawford, Elizabeth

    2012-01-01

    With recent interest in communities of practice, learning communities, and critical inquiry theory, the University of Tennessee at Chattanooga (UTC) developed, implemented, and studied the relationship of community and the cohort model. This paper shares information about successes and opportunities for improvement. Cohort-based learners across a…

  8. The natural history of asthma in a primary care cohort

    NARCIS (Netherlands)

    Winkler Prins, V.; Nieuwenhof, L.J.L. van den; Hoogen, H.J.M. van den; Bor, J.H.J.; Weel, C. van

    2004-01-01

    BACKGROUND: We examined the natural history of asthma in a primary care cohort of patients 10 years after the cohort was stratified for asthma risk by responses to a questionnaire and bronchial hyperresponsiveness (BHR) testing. METHODS: Children and young adults who were born between 1967 and 1979

  9. What Drives Teacher Engagement: A Study of Different Age Cohorts

    Science.gov (United States)

    Guglielmi, Dina; Bruni, Ilaria; Simbula, Silvia; Fraccaroli, Franco; Depolo, Marco

    2016-01-01

    Despite the growing body of research on work engagement, little is known about what drives work engagement among different age cohorts. This study aims to investigate whether engagement varies across age cohorts and examines the job resources that foster teacher engagement. A questionnaire was distributed to 537 teachers who were employed in…

  10. Subclinical Hyperthyroidism-A Cohort Study

    International Nuclear Information System (INIS)

    Objective: To compare the development of overt hyperthyroidism in a cohort of patients of subclinical hyperthyroidism (SCR) and in subjects with normal thyroid function tests. Study Design: A cohort study. Place and Duration of study: The study was conducted in the department of Chemical Pathology and Endocrinology, Armed Forces Institute of Pathology, Rawalpindi from Sept 2006 to Sept 2007. Patients and Methods: Fifty patients of SCR and almost equal number of age and sex-matched subjects with normal Thyroid function test (TFT) were included in the study as controls. Subclinical hyperthyroid patients and controls were followed for a period of one year on a six monthly basis. The patients were examined for signs and symptoms of hyperthyroidism and serum TSH, total T3 and free T4 were estimated. The clinical history, physical examination and TFT results were recorded. Five ml of blood was collected for serum thyroid profile in plain tube. Hormonal analysis(TSH, T4 and T3) was done for the patients and the controls enrolled in the study. The TFTs was analyzed using Chemiluminescence Immunoassay technique on Immulite 2000 an automated, random access, immunoassay analyzer. Results: Six (12%) out of 50 cases of the SCR patients and 2 (4%) out of 50 controls developed overt hyperthyroidism. SCR had no significant risk for conversion to overt hyperthyroidism as compared to healthy controls in this study. In addition to initial levels of serum TSH were one of important predictor for conversion of SCR to overt hyperthyroidism. Conclusion: Patients with SCR have no significant risk but showed an increase in frequency of conversion to overt hyperthyroidism (12% in this study) as compared to controls. (author)

  11. HIV cohort collaborations: proposal for harmonization of data exchange

    DEFF Research Database (Denmark)

    Kjær, Jesper; Ledergerber, Bruno

    2004-01-01

    HIV cohort studies have provided useful information on the natural history of HIV infection and the effects of antiretroviral therapy. It has become increasingly common to combine data from several cohorts into one dataset in order to address certain specific questions with more statistical power...... than can be achieved with the individual studies. This requires each cohort to map data into a standard format before merging. Until recently, this standard format has differed for each such collaborative analysis. We have therefore developed the HIV Cohort Data Exchange Protocol (HICDEP), which is...... freely available at http://www.cphiv.dk/HICDEP.pdf. Once individual cohorts have set up a means of transfering data into this format, as and when required, this should greatly facilitate data merging for future joint analyses. The HICDEP incorporates data from HIV drug resistance tests, which have been...

  12. Cohort profile: the Spanish WORKing life Social Security (WORKss) cohort study

    OpenAIRE

    L??pez G??mez, Mar??a Andr??e; Duran Jord??, Xavier, 1974-; Zaballa, Elena; S??nchez Niub??, Albert; Delclos, George L; Benavides, Fernando G.

    2016-01-01

    PURPOSE: The global economy is changing the labour market and social protection systems in Europe. The effect of both changes on health needs to be monitored in view of an ageing population and the resulting increase in prevalence of chronic health conditions. The Spanish WORKing life Social Security (WORKss) cohort study provides unique longitudinal data to study the impact of labour trajectories and employment conditions on health, in terms of sickness absence, permanent disability and deat...

  13. Cohort Profile: Golestan Hepatitis B Cohort Study- A Prospective Long Term Study in Northern Iran ​

    OpenAIRE

    Poustchi, Hossein; Katoonizadeh, Aezam; Ostovaneh, Mohammad Reza; Moossavi, Shirin; Sharafkhah, Maryam; Esmaili, Saeed; Pourshams, Akram; Mohamadkhani, Ashraf; Besharat, Sima; Merat, Shahin; Mohamadnejad, Mehdi; George, Jacob; Malekzadeh, Reza

    2014-01-01

    Hepatitis B virus (HBV) infection is the most common cause of end stage liver disease in Iran and in Golestan province. Large-scale population-based prospective cohort studies with long term follow-up are the method of choice to accurately understand the natural course of HBV infection. To date, several studies of HBV epidemiology, natural history, progression to cirrhosis and association with HCC have been reported from other countries. However, few of these are prospective and fewer still a...

  14. Cohort profile: golestan hepatitis B cohort study- a prospective long term study in northern iran ​.

    Science.gov (United States)

    Poustchi, Hossein; Katoonizadeh, Aezam; Ostovaneh, Mohammad Reza; Moossavi, Shirin; Sharafkhah, Maryam; Esmaili, Saeed; Pourshams, Akram; Mohamadkhani, Ashraf; Besharat, Sima; Merat, Shahin; Mohamadnejad, Mehdi; George, Jacob; Malekzadeh, Reza

    2014-10-01

    Hepatitis B virus (HBV) infection is the most common cause of end stage liver disease in Iran and in Golestan province. Large-scale population-based prospective cohort studies with long term follow-up are the method of choice to accurately understand the natural course of HBV infection. To date, several studies of HBV epidemiology, natural history, progression to cirrhosis and association with HCC have been reported from other countries. However, few of these are prospective and fewer still are population-based. Moreover, the underlying molecular mechanisms and immunogenetic determinants of the outcome of HBV infection especially in low and middle income countries remains largely unknown. Therefore, the hepatitis B cohort study (HBCS), nested as part of the Golestan Cohort Study (GCS), Golestan, Iran was established in 2008 with the objective to prospectively investigate the natural course of chronic hepatitis B with reference to its epidemiology, viral/host genetic interactions, clinical features and outcome in the Middle East where genotype D HBV accounts for >90% of infections. In 2008, a baseline measurement of HBV surface antigen (HBsAg) was performed on stored serum samples of all GCS participants. A sub-cohort of 3,505 individuals were found to be HBsAg positive and were enrolled in the Golestan HBCS. In 2011, all first degree relatives of HBsAg positive subjects including their children and spouses were invited for HBV serology screening and those who were positive for HBsAg were also included in the Golestan HBCS. PMID:25349681

  15. Cohort Amplification: An Associative Classification Framework for Identification of Disease Cohorts in the Electronic Health Record

    OpenAIRE

    Welch, Susan Rea; Huff, Stanley M.

    2010-01-01

    With the growing national dissemination of the electronic health record (EHR), there are expectations that algorithms to identify disease-based cohorts for health services research will be deployable across health care organizations. Toward that goal, a novel associative classification framework was designed to generate prediction rules to identify cases similar to the exemplar cases on which it was trained. It processes exemplars for any medical condition without modification. The framework ...

  16. Treatment of venous malformations: First experience with a new sclerosing agent – A multicenter study

    International Nuclear Information System (INIS)

    Purpose: To study the efficacy and safety of a new sclerosing gel of absolute ethanol in the percutaneous treatment of venous malformations (VM). Materials and methods: In this prospective, non-randomized multicenter study patients with clinically and by magnetic resonance imaging diagnosed VM were treated. Efficacy and safety of the gel was evaluated. Therapeutic outcome was judged at day 56 after the last sclerosing therapy. Blood ethanol levels of ethanol were measured after each infusion. Local and systemic adverse events were recorded. Results: Seventy-five (75) patients (age 4–46 y, mean 26 y) were treated in 172 sessions. Compared to no treatment, ethanol gel showed a complete cure rate of about 15% per session (p −1), with only one patient above the legal 0.5 g L−1 intoxication limit (0.6 g L−1). Forty-six (46) product-related adverse events (all local, none systemic) were reported. They included temporary mild isolated pain (N = 21), inflammatory reactions (N = 4), and local complications (7 skin necroses, 7compressive neuropathies, 4 product leakage/fistula, 2 intralesional fibrous or granulomatous tissue, 1 dense node; 12.2% of the infusions). All local complications resolved spontaneously, except for 2 skin necroses requesting surgical paring. Conclusion: Ethanol gel is an embosclerosing substance that provides high efficiency and improves safety of ethanol in the treatment of VM lesions.

  17. Rheumatic fever: a multicenter study in the State of São Paulo

    Directory of Open Access Journals (Sweden)

    Silva Carlos Henrique Martins da

    1999-01-01

    Full Text Available Rheumatic fever is still the most commonly seen rheumatic disease in Brazilian pediatric rheumatology clinics. It remains a significant health problem since subsequent cardiac sequelae represent one of the most important causes of chronic heart disease in children. We reviewed the clinical manifestations of rheumatic fever in 786 patients, followed at seven pediatric rheumatology clinics in the state of São Paulo, Brazil. All patients were diagnosed according to revised Jones' criteria. Regarding major criteria, 396 (50.4% children exhibited carditis, 453 (57.6% polyarthritis, 274 (34.8% chorea, 13 (1.6% erythema marginatum, and 12 (1.5% subcutaneous nodules. Valvular lesions documented by echocardiography in the absence of accompanying auscultatory findings were found in 144 (18.3% patients. Migratory polyarthritis was observed in 290 (64.0% patients with articular involvement. Documented previous streptococcal infection assessed by serum antistreptolysin (ASO titers occurred in 531 (67.5% patients. Even though prophylaxis with benzathine penicillin was recommended to all patients, recurrent attacks were observed in 147 (18.7%. We emphasize the high frequency of chorea, silent carditis and recurrences in our series as well as the variable clinical presentation of arthritis in rheumatic fever. Multicenter studies should be encouraged to improve our understanding of the clinical features of rheumatic diseases in children and adolescents.

  18. The Anti-Osteoporotic Drug Preferences of Physiatrists: A Multicenter Descriptive Study

    Directory of Open Access Journals (Sweden)

    Yeşim Gökçe Kutsal

    2012-08-01

    Full Text Available Aim: The purpose of this multicenter descriptive study is to determine the preferences of physiatrists in our country for anti-osteoporotic drugs in patients with primary and secondary osteoporosis. Materials and Methods: This study was carried out in 10 provinces of Turkey. The diagnosis of osteoporosis was based on World Health Organization criteria using dual-energy x-ray absorptiometry. Patients with a spine and/or hip T-score ≤-2.5 were considered as osteoporotic. 714 patients over 18 years old with primary or secondary osteoporosis were included in the study. In addition to socio-demographic characteristics and chronic use of medications and/or additional systemic diseases that cause secondary osteoporosis were questioned and antiosteoporotic drugs that are recommended by their physicians were recorded.Results: The physicians’ preferred vitamin D and calcium as the prior treatment both in primary and secondary osteoporosis. The most commonly used anti-osteoporotic agent was alendronate from the biphosphonate group. It was followed by ibandronate, risedronate, strontium ranelate, calcitonin, zoledronate, raloxifene, parathyroid hormone (PTH and hormone replacement therapy (HRT in the primary osteoporosis and risedronate, ibandronate, calcitonin, strontium ranelate, zoledronate, PTH, HRT and raloxifene in the secondary osteoporosis, respectively. Conclusion: The physician should choose the most suitable treatment for the patient based on fracture risk, medical history, previous treatments for osteoporosis, concomitant diseases, treatment-induced risks and benefits, and the relation between financial cost and potential benefit. (Turkish Journal of Osteoporosis 2012;18: 42-6

  19. Multicenter external quality assessment program for PCR detection of Mycobacterium ulcerans in clinical and environmental specimens.

    Directory of Open Access Journals (Sweden)

    Miriam Eddyani

    Full Text Available BACKGROUND: Mycobacterium ulcerans is the causative agent of Buruli ulcer (BU, a necrotizing disease of the skin, soft tissue and bone. PCR is increasingly used in the diagnosis of BU and in research on the mode of transmission and environmental reservoir of M. ulcerans. METHODOLOGY/PRINCIPAL FINDINGS: The aim of this study was to evaluate the performance of laboratories in detecting M. ulcerans using molecular tests in clinical and environmental samples by implementing sequential multicenter external quality assessment (EQA programs. The second round of the clinical EQA program revealed somewhat improved performance. CONCLUSIONS/SIGNIFICANCE: Ongoing EQA programs remain essential and continued participation in future EQA programs by laboratories involved in the molecular testing of clinical and environmental samples for M. ulcerans for diagnostic and research purposes is strongly encouraged. Broad participation in such EQA programs also benefits the harmonization of quality in the BU research community and enhances the credibility of advances made in solving the transmission enigma of M. ulcerans.

  20. N=2 SUGRA BPS multi-center black holes and freudenthal triple systems

    Directory of Open Access Journals (Sweden)

    Torrente-Lujan E.

    2015-01-01

    Full Text Available We present a detailed description of N = 2 stationary BPS multicenter black hole solutions for quadratic prepotentials with an arbitrary number of centers and scalar fields making a systematic use of the algebraic properties of the matrix of second derivatives of the prepotential, S, which in this case is a scalar-independent matrix. The anti-involution matrix S can be understood as a Freudenthal duality x̃ = Sx. We show that this duality can be generalized to “Freudenthal transformations” x→λexp(θSx=ax+bx˜$x \\to \\lambda \\exp \\left( {\\theta S} \\rightx = ax + b\\tilde x$ under which the horizon area, ADM mass and intercenter distances scale up leaving constant the scalars at the fixed points. In the special case λ = 1, “S-rotations”, the transformations leave invariant the solution. The standard Freudenthal duality can be written as x˜=exp (π2S x$\\tilde x = {\\rm{exp }}\\left( {{\\pi \\over 2}S} \\right{\\rm{ }}x$. We argue that these generalized transformations leave invariant not only the quadratic preotential theories but also the general stringy extremal quartic form Δ4, Δ4(x = Δ4(cos θx + sin θx̃ and therefore its entropy at lowest order.

  1. Prospective multi-center trial utilizing electronic brachytherapy for the treatment of endometrial cancer

    International Nuclear Information System (INIS)

    A modified form of high dose rate (HDR) brachytherapy has been developed called Axxent Electronic Brachytherapy (EBT). EBT uses a kilovolt X-ray source and does not require treatment in a shielded vault or a HDR afterloader unit. A multi-center clinical study was carried out to evaluate the success of treatment delivery, safety and toxicity of EBT in patients with endometrial cancer. A total of 15 patients with stage I or II endometrial cancer were enrolled at 5 sites. Patients were treated with vaginal EBT alone or in combination with external beam radiation. The prescribed doses of EBT were successfully delivered in all 15 patients. From the first fraction through 3 months follow-up, there were 4 CTC Grade 1 adverse events and 2 CTC Grade II adverse events reported that were EBT related. The mild events reported were dysuria, vaginal dryness, mucosal atrophy, and rectal bleeding. The moderate treatment related adverse events included dysuria, and vaginal pain. No Grade III or IV adverse events were reported. The EBT system performed well and was associated with limited acute toxicities. EBT shows acute results similar to HDR brachytherapy. Additional research is needed to further assess the clinical efficacy and safety of EBT in the treatment of endometrial cancer

  2. Response to Statin Therapy in Obstructive Sleep Apnea Syndrome: A Multicenter Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Marie Joyeux-Faure

    2014-01-01

    Full Text Available Rationale. Accumulated evidence implicates sympathetic activation as inducing oxidative stress and systemic inflammation, which in turn lead to hypertension, endothelial dysfunction, and atherosclerosis in obstructive sleep apnea (OSA. Statins through their pleiotropic properties may modify inflammation, lipid profile, and cardiovascular outcomes in OSA. Methods. This multicenter, randomized, double-blind study compared the effects of atorvastatin 40 mg/day versus placebo over 12 weeks on endothelial function (the primary endpoint measured by peripheral arterial tone (PAT. Secondary endpoints included office blood pressure (BP, early carotid atherosclerosis, arterial stiffness measured by pulse wave velocity (PWV, and metabolic parameters. Results. 51 severe OSA patients were randomized. Key demographics for the study population were age 54 ± 11 years, 21.6% female, and BMI 28.5 ± 4.5 kg/m2. In intention to treat analysis, mean PAT difference between atorvastatin and placebo groups was 0.008 (−0.29; 0.28, P=0.979. Total and LDL cholesterol significantly improved with atorvastatin. Systolic BP significantly decreased with atorvastatin (mean difference: −6.34 mmHg (−12.68; −0.01, P=0.050 whereas carotid atherosclerosis and PWV were unchanged compared to the placebo group. Conclusion. In OSA patients, 3 months of atorvastatin neither improved endothelial function nor reduced early signs of atherosclerosis although it lowered blood pressure and improved lipid profile. This trial is registered with NCT00669695.

  3. The design and protocol of acupuncture for migraine prophylaxis: A multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Li Jingdao

    2009-04-01

    Full Text Available Abstract Background Many studies have already reported encouraging results in the prophylactic therapy of migraine by acupuncture, but there seems to be a lack of high quality randomized controlled trials from China. We design and perform a randomized controlled clinical trial to evaluate the efficacy of acupuncture compared with flunarizine in the prophylactic therapy of patients with migraine without aura in China. Methods This trial is a multicenter, prospective, randomized controlled clinical trial. The 140 migraine patients are randomly allocated to two different groups. The acupuncture groups (n = 70 is treated with acupuncture and placebo medicine; while the control group (n = 70 is treated with sham acupuncture and medicine (Flunarizine. Both Flunarizine and placebo are taken 10 mg once per night for the first 2 weeks and then 5 mg once per night for the next 2 weeks. Patients in both groups receive 12 sessions of verum/sham acupuncture in 4 weeks. Discussion The study design and the long term clinical practice of acupuncturists guarantee a high external validity for the results. The results of our trial will be helpful to supply the evidence on the efficacy of acupuncture for migraine prophylaxis in China. Trial Registration The trial is registered at Controlled Clinical Trials: ISRCTN49839714.

  4. Mirtazapine in the treatment of adolescents with major depression: an open-label, multicenter pilot study.

    Science.gov (United States)

    Haapasalo-Pesu, Kirsi-Maria; Vuola, Tapani; Lahelma, Liisa; Marttunen, Mauri

    2004-01-01

    This multicenter, open-label study with a duration of 85 days was performed to evaluate the antidepressant efficacy and safety of mirtazapine (dose range, 30-45 mg) in 12-18-year-old adolescents diagnosed with major depression. Twenty-four (24) patients (15 female patients and 9 male patients) meeting the DSM-IV criteria for major depression and the Hamilton Rating Scale for Depression (HAM-D-17) score of 18 at baseline were enrolled in the study. The primary outcome measures were HAM-D-17, Beck Depression Inventory (BDI), and Clinical Global Impression (CGI) scales. Any changes in symptoms of anxiety were measured using the Hamilton Anxiety Rating Scale (HAM-A). The average age of the 23 subjects, who were eligible for analysis, was 16.3 years (standard deviation (SD) 6.11, median 17.3). The mean daily dose of mirtazapine was 32.9 mg. Mirtazapine showed a marked efficacy on all rating scales and was well tolerated. Mirtazapine had a beneficial effect on sleep. A rapid onset of sleep and pattern of action was seen. No dropouts due to adverse events were recorded. The most common treatment-emergent adverse events were tiredness, increased appetite, and dizziness. The results of this study suggest that mirtazapine may be an effective treatment for major depression in adolescents. PMID:15319015

  5. THE RATE OF METABOLIC SYNDROME AND COMORBIDITIES IN PATIENTS WITH GOUT: DATA OF A MULTICENTER TRIAL

    Directory of Open Access Journals (Sweden)

    V G Barskova

    2012-01-01

    Full Text Available Objective: to study the rate of metabolic syndrome (MS and its components among gout patients in different regions of the Russian Federation. Subjects and methods. This cross-sectional multicenter study enrolled 2277 gout patients, including 1963 (86.2% men and 314 (13.8% women, from 12 independent medical centers in different regions of the Russian Federation. The patients over 18 years of age who met the classification criteria for gout, elaborated by S. Wallace et al., were included. The diagnosis of MS was established on the basis of Adult Treatment Panel III (ATP III criteria. The presence of MS, its individual components and comorbidities were recorded. Results. The total rate of MS in the patients with gout was 57%; however, it varied substantially (from 15 to 77% in different centers. Among the comorbidities, arterial hypertension was most common (in three fourths of the patients, coronary heart disease (CHD and type 2 diabetes mellitus were less common (43 and 25%, respectively; 15% of the patients had sustained myocardial infarction, renal and cardiac failure was also observed in 15%. In the gout patients, MS was associated with the presence of CHD. Conclusion. The patients with gout were observed to have a high rate of MS (57%, its components, and cardiovascular diseases. The findings suggest that there is a relationship between the presence of MS and the development of CHD.

  6. Control chart analysis of data from a multicenter monitor unit verification study

    International Nuclear Information System (INIS)

    Background and purpose: This study aims to investigate the process of monitor unit verification using control charts. Control charts is a key tool within statistical process control (SPC), through which process characteristics can be visualized, usually chronologically with statistically determined limits. Material and methods: Our group has developed a monitor unit verification software that has been adopted at several Swedish institutions for pre-treatment verification of radiotherapy treatments. Deviations between point dose calculations using the treatment planning systems and using the independent monitor unit verification software from 9219 treatment plans and five different institutions were included in this multicenter study. The process of monitor unit verification was divided into subprocesses. Each subprocess was analyzed using probability plots and control charts. Results: Differences in control chart parameters for the investigated subprocesses were found between different treatment sites and different institutions, as well as between different treatment techniques. 19 of 37 subprocesses met the clinical specification (±5%), i.e. process capability index was equal to or above one. Conclusions: Control charts were found to be a useful tool for continuous analysis of data from the monitor unit verification software for patient specific quality control, as well as for comparisons between different institutions and treatment sites. The derived control chart limits were in agreement with AAPM TG114 guidelines on action levels.

  7. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial

    Directory of Open Access Journals (Sweden)

    Usman Anju

    2009-03-01

    Full Text Available Abstract Background Several uncontrolled studies of hyperbaric treatment in children with autism have reported clinical improvements; however, this treatment has not been evaluated to date with a controlled study. We performed a multicenter, randomized, double-blind, controlled trial to assess the efficacy of hyperbaric treatment in children with autism. Methods 62 children with autism recruited from 6 centers, ages 2–7 years (mean 4.92 ± 1.21, were randomly assigned to 40 hourly treatments of either hyperbaric treatment at 1.3 atmosphere (atm and 24% oxygen ("treatment group", n = 33 or slightly pressurized room air at 1.03 atm and 21% oxygen ("control group", n = 29. Outcome measures included Clinical Global Impression (CGI scale, Aberrant Behavior Checklist (ABC, and Autism Treatment Evaluation Checklist (ATEC. Results After 40 sessions, mean physician CGI scores significantly improved in the treatment group compared to controls in overall functioning (p = 0.0008, receptive language (p Conclusion Children with autism who received hyperbaric treatment at 1.3 atm and 24% oxygen for 40 hourly sessions had significant improvements in overall functioning, receptive language, social interaction, eye contact, and sensory/cognitive awareness compared to children who received slightly pressurized room air. Trial Registration clinicaltrials.gov NCT00335790

  8. Photorejuvenation with intense pulsed light: results of a multi-center study.

    Science.gov (United States)

    Sadick, Neil S; Weiss, Robert; Kilmer, Suzanne; Bitter, Patrick

    2004-01-01

    This multi-center study evaluating the role of Intense Pulsed Light (IPL) in the non-ablative rejuvenation of Type I and Type II photoaged skin study was conducted in order to evaluate the clinical efficacy and safety of using IPL in treating clinical indications associated with photoaged skin. Ninety-three patients of Fitzpatrick skin phenotypes I-III, Fitzpatrick Wrinkle Classes I-II, and Elastosis Scores 1-6 were enrolled in the study. Up to five treatments were performed at 4-week intervals with follow-up visits at 4 and 6 months after the last treatment. Patients received full-face treatments using the recommended parameters of the Quantum SR/HR (Lumenis Ltd.) with the 560 or 640 nm cutoff filter. Parameters of elastometry, physicians' evaluation of the Elastosis Score ('W/ES'), and global improvement as well as patient satisfaction were analyzed. Results showed that the average Fitzpatrick W/ES improved significantly (pIPL treatment is an effective non-invasive, non-ablative method for rejuvenating photoaged skin with minimal adverse events, no downtime, excellent long-term results, and a very high measure of patient satisfaction. PMID:14964745

  9. Multicenter survey on the use of device-assisted enteroscopy in Portugal

    Science.gov (United States)

    Mascarenhas-Saraiva, Miguel; Mão-de-Ferro, Susana; Ferreira, Sara; Almeida, Nuno; Figueiredo, Pedro; Rodrigues, Adélia; Cardoso, Hélder; Marques, Margarida; Rosa, Bruno; Cotter, José; Vilas-Boas, Germano; Cardoso, Carla; Salgado, Marta; Marcos-Pinto, Ricardo

    2015-01-01

    Background Device-assisted enteroscopies (DAEs) are recent endoscopic techniques that enable direct endoscopic small-bowel evaluation. Objective The objective of this article is to evaluate the implementation of DAEs in Portugal and assess the main indications, diagnoses, diagnostic yield, therapeutic yield and complication rate. Methods We conducted a multicenter retrospective series using a national Web-based survey on behalf of the Portuguese Small-Bowel Study Group. Participants were asked to fill out two online databases regarding procedural data, indications, diagnoses, endoscopic therapy and complications using prospectively collected institutional data records. Results A total of eight centers were enrolled in the survey, corresponding to 1411 DAEs. The most frequent indications were obscure gastrointestinal bleeding (OGIB), inflammatory bowel disease and small-bowel tumors. The pooled diagnostic yield was 63%. A relation between the diagnostic yield and the indications was clear, with a diagnostic yield for OGIB of 69% (p = 0.02) with a 52% therapeutic yield. Complications occurred in 1.2%, with a major complication rate of 0.57%. Perforations occurred in four patients (0.28%). Conclusion DAEs are safe and effective procedures, with complication rates of 1.2%, the most serious of which is perforation. Most procedures are performed in the setting of OGIB. Diagnostic and therapeutic yields are dependent on the indication, hence appropriate patient selection is crucial. PMID:27087956

  10. Incidence of Malignancy after Living Kidney Transplantation: A Multicenter Study from Iran

    Science.gov (United States)

    Einollahi, Behzad; Rostami, Zohreh; Nourbala, Mohammad Hossein; Lessan-Pezeshki, Mahboob; Simforoosh, Naser; Nemati, Eghlim; Pourfarziani, Vahid; Beiraghdar, Fatemeh; Nafar, Mohsen; Pour-Reza-Gholi, Fatemeh; Mazdeh, Mitra Mahdavi; Amini, Manochehr; Ahmadpour, Pedram; Makhdoomi, Khadijeh; Ghafari, Ali; Ardalan, Mohammad Reza; Khosroshahi, Hamid Taebi; Oliaei, Farshid; Shahidi, Shahrzad; Abbaszadeh, Shahin; Fatahi, Mohammad Reza; Hiedari, Fatemeh; Makhlogh, Atehieh; Azmandian, Jalal; Samimagham, Hamid Reza; Shahbazian, Heshmatollah; Nazemian, Fatemeh; Naghibi, Massih; Khosravi, Masoud; Monfared, Ali; Mosavi, Seyed Majid; Ahmadi, Javad; Jalalzadeh, Mojgan

    2012-01-01

    Malignancy is a common complication after renal transplantation. However, limited data are available on post-transplant malignancy in living kidney transplantation. Therefore, we made a plan to evaluate the incidence and types of malignancies, association with the main risk factors and patient survival in a large population of living kidney transplantation. We conducted a large retrospective multicenter study on 12525 renal recipients, accounting for up to 59% of all kidney transplantation in Iran during 22 years follow up period. All information was collected from observation of individual notes or computerized records for transplant patients. Two hundred and sixty-six biopsy-proven malignancies were collected from 16 Transplant Centers in Iran; 26 different type of malignancy categorized in 5 groups were detected. The mean age of patients was 46.2±12.9 years, mean age at tumor diagnosis was 50.8±13.2 years and average time between transplantation and detection of malignancy was 50.0±48.4 months. Overall tumor incidence in recipients was 2%. Kaposis' sarcoma was the most common type of tumor. The overall mean survival time was 117.1 months (95% CI: 104.9-129.3). In multivariate analysis, the only independent risk factor associated with mortality was type of malignancy. This study revealed the lowest malignancy incidence in living unrelated kidney transplantation. PMID:22712025

  11. Clinical application of {sup 99m}Tc-tetrofosmin myocardial SPECT. A multicenter trial

    Energy Technology Data Exchange (ETDEWEB)

    Nishimura, Tsunehiko [Osaka Univ. (Japan). Faculty of Medicine; Nobuyoshi, Masakiyo

    1995-09-01

    We performed a multicenter trial of {sup 99m}Tc-tetrofosmin myocardial SPECT for the assessment of acute thrombolysis, pre and post elective PTCA and myocardial viability in comparison with {sup 201}Tl myocardial SPECT. The participants consisted of 212 patients at 44 institutions and the study lasted for 10 months. In assessing acute thrombolysis, the perfusion defect from the acute to subacute phase was reduced by 25% and that from the subacute to chronic phase by 10%. The mean perfusion defect score at subacute and chronic phase was well correlated with regional wall motion. The mean defect score during the subacute phase could predict future wall motion abnormalities. In assessing pre and post PTCA, {sup 99m}Tc-tetrofosmin stress/rest myocardial SPECT could identify the changes of perfusion as in the case with successful PTCA and/or restenosis. In assessing the myocardial viability, {sup 99m}Tc-tetrofosmin rest myocardial SPECT was superior to {sup 201}Tl redistribution, and equal to {sup 201}Tl reinjection method. In summary, we concluded that {sup 99m}Tc-tetrofosmin is a powerful tool, with which to diagnose and manage patients with coronary artery diseases. (author).

  12. Association between tumor size and Breslow's thickness in malignant melanoma: a cross-sectional, multicenter study.

    Science.gov (United States)

    Moreno-Ramírez, David; Ojeda-Vila, Teresa; Ríos-Martín, Juan J; Nieto-García, Adoración; Ferrándiz, Lara

    2015-10-01

    The aim of this study was to assess the potential role of tumor diameter in explaining variations in tumoral invasion and in the initial prognosis for patients with malignant melanoma (MM). This was a multicenter, cross-sectional study that recruited between 2000 and 2009 patients with primary in-situ MM (Tis) and invasive cutaneous MM. Tis and MMs with a Breslow's thickness less than 1 mm (T1) were grouped (Tis-T1) and tumors with a Breslow's thickness 1 mm or more were also analyzed in combination (T2-T4). The tumor size was measured after routine formalin tissue fixation. Primary outcomes were the correlation between Breslow's thickness and tumor size, and the role of tumor size in explaining variations in Breslow's thickness, as assessed by the Pearson correlation test and logistic binary regression with calculation of the odds ratios. A total of 1610 MM patients were included and analyzed. The Pearson correlation between tumor size and Breslow's thickness was 0.42, with a determination coefficient of R2=0.18 (P>0.01). Correlations between tumor size and thickness were stronger in patients aged 30-60 years (r=0.42, R2=0.1764, Pstrength of this association has been moderate. Tumor size explains a low burden of the variation observed in the Breslow's thickness. PMID:26237766

  13. Complications of Microwave Ablation for Liver Tumors: Results of a Multicenter Study

    Energy Technology Data Exchange (ETDEWEB)

    Livraghi, Tito, E-mail: lalivra@tin.it [IRCCS Istituto Clinico Humanitas, Department of Interventional Radiology (Italy); Meloni, Franca, E-mail: meloni@yahoo.it [San Gerardo Hospital, Department of Radiology (Italy); Solbiati, Luigi, E-mail: lusolbia@tin.it [Azienda Ospedaliera di Busto Arsizio, Department of Interventional Radiology (Italy); Zanus, Giorgio, E-mail: zanus@unipd.it [Azienda Universita di Padova, General Surgery and Organ Transplantation (Italy); Collaboration: For the Collaborative Italian Group using AMICA system

    2012-08-15

    Purpose: New technologies for microwave ablation (MWA) have been conceived, designed to achieve larger areas of necrosis compared with radiofrequency ablation (RFA). The purpose of this study was to report complications by using this technique in patients with focal liver cancer. Methods: Members of 14 Italian centers used a 2.45-GMHz generator delivering energy through a cooled miniature-choke MW antenna and a standardized protocol for follow-up. They completed a questionnaire regarding number and type of deaths, major and minor complications and side effects, and likelihood of their relationship to the procedure. Enrollment included 736 patients with 1.037 lesions: 522 had hepatocellular carcinoma with cirrhosis, 187 had metastases predominantly from colorectal cancer, and 27 had cholangiocellular carcinoma. Tumor size ranged from 0.5 to 10 cm. In 13 centers, the approach used was percutaneous, in 4 videolaparoscopic, and in 3 laparotomic. Results: No deaths were reported. Major complications occurred in 22 cases (2.9%), and minor complications in 54 patients (7.3%). Complications of MWA do not differ from those RFA, both being based on the heat damage. Conclusion: Results of this multicenter study confirmed those of single-center experiences, indicating that MWA is a safe procedure, with no mortality and a low rate of major complications. The low rate of complications was probably due to precautions adopted, knowing in advance possible risk conditions, on the basis of prior RFA experience.

  14. Comprehensive rehabilitation with integrative medicine for subacute stroke: A multicenter randomized controlled trial.

    Science.gov (United States)

    Fang, Jianqiao; Chen, Lifang; Ma, Ruijie; Keeler, Crystal Lynn; Shen, Laihua; Bao, Yehua; Xu, Shouyu

    2016-01-01

    To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton's Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation. PMID:27174221

  15. Prospective multi-center trial utilizing electronic brachytherapy for the treatment of endometrial cancer

    Directory of Open Access Journals (Sweden)

    Thropay John P

    2010-07-01

    Full Text Available Abstract Background A modified form of high dose rate (HDR brachytherapy has been developed called Axxent Electronic Brachytherapy (EBT. EBT uses a kilovolt X-ray source and does not require treatment in a shielded vault or a HDR afterloader unit. A multi-center clinical study was carried out to evaluate the success of treatment delivery, safety and toxicity of EBT in patients with endometrial cancer. Methods A total of 15 patients with stage I or II endometrial cancer were enrolled at 5 sites. Patients were treated with vaginal EBT alone or in combination with external beam radiation. Results The prescribed doses of EBT were successfully delivered in all 15 patients. From the first fraction through 3 months follow-up, there were 4 CTC Grade 1 adverse events and 2 CTC Grade II adverse events reported that were EBT related. The mild events reported were dysuria, vaginal dryness, mucosal atrophy, and rectal bleeding. The moderate treatment related adverse events included dysuria, and vaginal pain. No Grade III or IV adverse events were reported. The EBT system performed well and was associated with limited acute toxicities. Conclusions EBT shows acute results similar to HDR brachytherapy. Additional research is needed to further assess the clinical efficacy and safety of EBT in the treatment of endometrial cancer.

  16. Extremal Multicenter Black Holes: Nilpotent Orbits and Tits Satake Universality Classes

    CERN Document Server

    Fre, Pietro

    2012-01-01

    Four dimensional supergravity theories whose scalar manifold is a symmetric coset manifold U[D=4]/Hc are arranged into a finite list of Tits Satake universality classes. Stationary solutions of these theories, spherically symmetric or not, are identified with those of an euclidian three-dimensional sigma-model, whose target manifold is a Lorentzian coset U[D=3]/H* and the extremal ones are associated with H* nilpotent orbits in the K* representation emerging from the orthogonal decomposition of the algebra U[D=3] with respect to H*. It is shown that the classification of such orbits can always be reduced to the Tits-Satake projection and it is a class property of the Tits Satake universality classes. The construction procedure of Bossard et al of extremal multicenter solutions by means of a triangular hierarchy of integrable equations is completed and converted into a closed algorithm by means of a general formula that provides the transition from the symmetric to the solvable gauge. The question of the relat...

  17. Cohort Profile: Sympathetic activity and Ambulatory Blood Pressure in Africans (SABPA) prospective cohort study.

    Science.gov (United States)

    Malan, Leoné; Hamer, Mark; Frasure-Smith, Nancy; Steyn, Hendrik S; Malan, Nicolaas T

    2015-12-01

    Adapting to an over-demanding stressful urban environment may exhaust the psychophysiological resources to cope with these demands, and lead to sympathetic nervous system dysfunction. The evidence that an urban-dwelling lifestyle may be detrimental to the cardiometabolic health of Africans motivated the design of the Sympathetic activity and Ambulatory Blood Pressure in African Prospective cohort study. We aimed to determine neural mechanistic pathways involved in emotional distress and vascular remodelling. The baseline sample included 409 teachers representing a bi-ethnic sex cohort from South Africa. The study was conducted in 2008-09 and repeated after 3-year follow-up in 2011-12, with an 87.8% successful follow-up rate. Seasonal changes were avoided and extensive clinical assessments were performed in a well-controlled setting. Data collection included sociodemographics, lifestyle habits, psychosocial battery and genetic analysis, mental stress responses mimicking daily life stress (blood pressure and haemostatic, cardiometabolic, endothelial and stress hormones). Target organ damage was assessed in the brain, heart, kidney, blood vessels and retina. A unique highly phenotyped cohort is presented that can address the role of a hyperactive sympathetic nervous system and neural response pathways contributing to the burden of cardiometabolic diseases in Africans. PMID:25344943

  18. Comparative efficacy of fingolimod vs natalizumab: A French multicenter observational study

    OpenAIRE

    Barbin, Laetitia; Rousseau, Chloé; Jousset, Natacha; Casey, Romain; Debouverie, Marc; Vukusic, Sandra; De Sèze, Jerome; Brassat, David; Wiertlewski, Sandrine; Brochet, Bruno; Pelletier, Jean; Vermersch, Patrick; Edan, Gilles; Lebrun-Frenay, Christine; Clavelou, Pierre

    2016-01-01

    OBJECTIVE: To compare natalizumab and fingolimod on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) from 27 multiple sclerosis centers participating in the French follow-up cohort Observatoire of Multiple Sclerosis. METHODS: Patients with RRMS included in the study were aged from 18 to 65 years with an Expanded Disability Status Scale score of 0-5.5 and an available brain MRI performed within the year before treatment initiation. The data were col...

  19. PanScan, the Pancreatic Cancer Cohort Consortium, and the Pancreatic Cancer Case-Control Consortium

    Science.gov (United States)

    The Pancreatic Cancer Cohort Consortium consists of more than a dozen prospective epidemiologic cohort studies within the NCI Cohort Consortium, whose leaders work together to investigate the etiology and natural history of pancreatic cancer.

  20. Cohort Working Life Tables for Older Canadians

    Directory of Open Access Journals (Sweden)

    Spencer, Byron G.

    2010-01-01

    Full Text Available AbstractWe construct cohort working life tables for Canadian men and women aged 50and older and, for comparison, corresponding period tables. The tables arederived using annual single-age time series of participation rates for 1976-2006from the master files of the Statistics Canada Labour Force Survey. The cohortcalculations are based on stochastic projections of mortality coupled withalternative assumptions about future participation rates. Separate tables areprovided for the years 1976, 1991, and 2006, thus spanning a period ofsubstantial gains in life expectancy and strong upward trends in femaleparticipation. Life expectancies based on the cohort tables are greater thanthose based on the period tables, for both men and women, and that is reflectedin increased retirement expectancies. For example, a male aged 50 in 1976could have expected to live three years longer and to have almost four moreyears in retirement, based on the male cohort table under medium assumptions,as compared with the corresponding period table.RésuméNous avons établis des tables de vie active par génération pour les Canadiens etCanadiennes âgés de 50 ans ou plus ainsi que des tables du momentcorrespondantes pour servir de comparaison. Les tables sont dérivées à l'aidede séries chronologiques annuelles d'un seul âge pour le taux d'activité pour lesannées 1976 à 2006 provenant des fichiers maîtres de l'Enquête sur lapopulation active de Statistique Canada. Les calculs par génération sont baséessur des projections stochastiques de mortalité et sur des suppositions quant àde futurs taux d'activité possibles. Des tables séparées ont été établies pour lesannées 1976, 1991 et 2006 ; ce qui représente une période qui a vu des gainssubstantiels en ce qui concerne l'espérance de vie et une forte hausse d'activitéchez les femmes. Les espérance de vie basées sur les tables par génération sontplus élevées que celles basées sur les tables du

  1. Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

    Science.gov (United States)

    Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

    2013-01-01

    New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies. PMID:20703765

  2. HIV cohort collaborations: proposal for harmonization of data exchange

    DEFF Research Database (Denmark)

    Kjær, Jesper; Ledergerber, Bruno

    2004-01-01

    than can be achieved with the individual studies. This requires each cohort to map data into a standard format before merging. Until recently, this standard format has differed for each such collaborative analysis. We have therefore developed the HIV Cohort Data Exchange Protocol (HICDEP), which is...... freely available at http://www.cphiv.dk/HICDEP.pdf. Once individual cohorts have set up a means of transfering data into this format, as and when required, this should greatly facilitate data merging for future joint analyses. The HICDEP incorporates data from HIV drug resistance tests, which have been...

  3. Cohort profile: the Young Lives study.

    Science.gov (United States)

    Barnett, Inka; Ariana, Proochista; Petrou, Stavros; Penny, Mary E; Duc, Le Thuc; Galab, S; Woldehanna, Tassew; Escobal, Javier A; Plugge, Emma; Boyden, Jo

    2013-06-01

    Young Lives is an international longitudinal study investigating the changing nature of childhood poverty in four low-income countries [Ethiopia, India (Andhra Pradesh), Peru and Vietnam] over a 15-year period. In each country, the cohort is comprised of ≈ 2000 children aged between 6 and 18 months and up to 1000 children aged between 7 and 8 years, recruited in 2002 and sampled from 20 sentinel sites. The first survey data collection from primary caregivers and older children took place in 2002, the second in 2006-07 and the third in 2009-10. Data on the community contexts were collected to complement the household surveys. To elaborate and extend the quantitative data, longitudinal qualitative research with a subgroup of the children was carried out in 2007, 2008 and 2010-11. Topic areas covered included nutrition, health and well-being, cognitive and physical development, health behaviours and education, as well as the social, demographic and economic status of the household. Survey data from the study are archived in the International Section of the UK Public Data Archive. PMID:22617687

  4. Sex effects on short-term complications after hip fracture: a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Ekström W

    2015-08-01

    Full Text Available Wilhelmina Ekström,1 Bodil Samuelsson,2 Sari Ponzer,3 Tommy Cederholm,4,5 Karl-Göran Thorngren,6 Margareta Hedström7 1Department of Molecular Medicine and Surgery, Section of Orthopaedics and Sports Medicine, Karolinska Institutet, Karolinska University Hospital, Solna, 2Department of Clinical Sciences, Karolinska Institutet, Danderyd Hospital, 3Department of Clinical Science and Education, Section of Orthopaedics, Karolinska Institutet, Södersjukhuset, Stockholm, 4Department of Public Health and Caring Sciences, 5Department of Geriatrics, Uppsala University, Uppsala University Hospital, Uppsala, 6Department of Clinical Sciences, Lund, Orthopaedics, Lund University, Lund, 7Department of Orthopaedics, Institute of Clinical Science, Intervention and Technology (CLINTEC, Karolinska University Hospital, Huddinge, Stockholm, Sweden Objectives: To evaluate potential sex differences and other factors associated with complications within 4 months after a hip fracture.Methods: A total of 1,915 patients ≥65 years (480 men with hip fracture were consecutively included in a prospective multicenter cohort study. A review of medical records and patient interviews according to a study protocol based on the Standardized Audit of Hip Fractures in Europe (SAHFE, RIKSHÖFT was performed. Sex differences in comorbidity according to the American Society of Anesthesiologists score and complications 4 months after a hip fracture were registered. Multivariate logistic regression analysis was performed to identify factors related to complications.Results: Male sex was associated with worse general health according to the American Society of Anesthesiologists classification (P=0.005 and with more comorbidities (P<0.001. Male sex emerged as a risk factor for developing pneumonia (P<0.001, and additionally, 18% of the men suffered from cardiac complications compared with 13% of the females (P=0.018. Female sex was predisposed for urinary tract infections, 30% vs 23

  5. Diet and lifestyle interventions in postpartum women in China: study design and rationale of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Fu Juan

    2010-02-01

    Full Text Available Abstract Background "Doing the month", or "sitting month", is a traditional practice for postpartum women in China and other Asian countries, which includes some taboos against well-accepted healthy diet and lifestyles in general population. Previous studies have shown this practice may be associated with higher prevalence of postpartum problems. The current multicenter randomized controlled trial (RCT aims to evaluate outcomes of diet and lifestyle interventions in Chinese postpartum women. Methods/Design The current multicenter RCT will be conducted in three representative areas in China, Shandong province, Hubei province and Guangdong province, which locate in northern, central and southern parts of China, respectively. Women who attend routine pregnancy diagnosis in hospitals or maternal healthcare centers will be invited to take part in this study. At least 800 women who meet our eligibility criteria will be recruited and randomly assigned to the intervention group (n > = 400 and the control group (n > = 400. A three-dimension comprehensive intervention strategy, which incorporates intervention measures simultaneously to individual postpartum woman, their family members and community environment, will be utilized to maximize the effectiveness of intervention. Regular visiting and follow-up will be done in both group; nutrition and health-related measurements will be assessed both before and after the intervention. Discussion To our knowledge, this current study is the first and largest multicenter RCT which focus on the effectiveness of diet and lifestyle intervention on reducing the incidence rate of postpartum diseases and improving health status in postpartum women. We hypothesize that the intervention will reduce the incidence rates of postpartum diseases and improve nutrition and health status due to a balanced diet and reasonable lifestyle in comparison with the control condition. If so, the results of our study will provide

  6. Do Clinicians Know Which of Their Patients Have Central Venous Catheters? A Multicenter Observational Study

    Science.gov (United States)

    Chopra, Vineet; Govindan, Sushant; Kuhn, Latoya; Ratz, David; Sweis, Randy F.; Melin, Natalie; Thompson, Rachel; Tolan, Aaron; Barron, James; Saint, Sanjay

    2016-01-01

    Background Complications associated with central venous catheters (CVCs) increase over time. Although early removal of unnecessary CVCs is important to prevent complications, the extent to which clinicians are aware that their patients have a CVC is unknown. Objective To assess how often clinicians were aware of the presence of triple-lumen or peripherally inserted central catheters (PICCs) in hospitalized patients. Design Multicenter, cross-sectional study. Setting Three academic medical centers in the United States. Patients Hospitalized medical patients in intensive care unit (ICU) and non-ICU settings. Measurements To ascertain awareness of CVCs, we first determined whether a PICC or triple-lumen catheter was present; clinicians were then queried about device presence. Differences in device awareness among clinicians were assessed by chi-square tests. Results 990 patients were evaluated, and 1881 clinician assessments were done. The overall prevalence of CVCs was 21.1% (n = 209), of which 60.3% (126 of 209) were PICCs. A total of 21.2% (90 of 425) of clinicians interviewed were unaware of the presence of a CVC. Unawareness was greatest among patients with PICCs, where 25.1% (60 of 239) of clinicians were unaware of PICC presence. Teaching attendings and hospitalists were more frequently unaware of the presence of CVCs than interns and residents (25.8% and 30.5%, respectively, vs. 16.4%). Critical care physicians were more likely to be aware of CVC presence than general medicine physicians (12.6% vs. 26.2%; P = 0.003). Limitations Awareness was determined at 1 point in time and not linked to outcomes. Patient length of stay and indication for CVC were not recorded. Conclusion Clinicians are frequently unaware of the presence of PICCs and triple-lumen catheters in hospitalized patients. Further study of mechanisms that ensure that clinicians are aware of these devices so that they may assess their necessity seems warranted. Primary Funding Source None. PMID

  7. Multi-Center MRI Carotid Plaque Component Segmentation Using Feature Normalization and Transfer Learning.

    Science.gov (United States)

    van Engelen, Arna; van Dijk, Anouk C; Truijman, Martine T B; Van't Klooster, Ronald; van Opbroek, Annegreet; van der Lugt, Aad; Niessen, Wiro J; Kooi, M Eline; de Bruijne, Marleen

    2015-06-01

    Automated segmentation of plaque components in carotid artery magnetic resonance imaging (MRI) is important to enable large studies on plaque vulnerability, and for incorporating plaque composition as an imaging biomarker in clinical practice. Especially supervised classification techniques, which learn from labeled examples, have shown good performance. However, a disadvantage of supervised methods is their reduced performance on data different from the training data, for example on images acquired with different scanners. Reducing the amount of manual annotations required for each new dataset will facilitate widespread implementation of supervised methods. In this paper we segment carotid plaque components of clinical interest (fibrous tissue, lipid tissue, calcification and intraplaque hemorrhage) in a multi-center MRI study. We perform voxelwise tissue classification by traditional same-center training, and compare results with two approaches that use little or no annotated same-center data. These approaches additionally use an annotated set of different-center data. We evaluate 1) a nonlinear feature normalization approach, and 2) two transfer-learning algorithms that use same and different-center data with different weights. Results showed that the best results were obtained for a combination of feature normalization and transfer learning. While for the other approaches significant differences in voxelwise or mean volume errors were found compared with the reference same-center training, the proposed approach did not yield significant differences from that reference. We conclude that both extensive feature normalization and transfer learning can be valuable for the development of supervised methods that perform well on different types of datasets. PMID:25532205

  8. Clinical impact of whole body FDG-PET for recurrent biliary cancer. A multicenter study

    International Nuclear Information System (INIS)

    The objective of this study was to evaluate the clinical usefulness of positron emission tomography (PET) using 18F-fluorodeoxyglucose (FDG) in patients with follow-up or suspected recurrent biliary cancer in a multicenter study. We performed a retrospective review of 50 patients who underwent FDG-PET (either integrated PET/CT or manual fusion of dedicated PET and CT) scans for post-treatment surveillance of biliary cancer. Recurrence was suspected in 40 of these patients on the basis of tumor marker levels, and/or findings of conventional imaging (group A). Clinical findings in the remaining 10 patients showed them to be disease-free (group B). The diagnostic performance and clinical impact of PET were analyzed. Recurrence was confirmed in 28 out of the 40 patients in group A, and 1 of the 10 patients in group B. Patient-based analysis showed that the sensitivity, specificity, and accuracy of PET for detecting recurrence were 86% (25/29), 91% (19/21), and 88% (44/50), respectively. The one patient with recurrence in group B was correctly interpreted by PET. Positive test likelihood ratio and negative test likelihood ratio were increased from 1.69 to 9.05, and 0.08 to 0.32, respectively, after PET study. The findings of PET resulted in a change of management for 10 out of the 50 patients (20%) by initiating an unplanned treatment strategy (n=7), by obviating the need for planned diagnostic procedures (n=2), or by changing the treatment plan (n=1). FDG-PET/CT or PET with CT yielded helpful information in patients with suspected recurrent biliary cancer. (author)

  9. Epidemiology of acute kidney injury in Hungarian intensive care units: a multicenter, prospective, observational study

    Directory of Open Access Journals (Sweden)

    Bencsik Gabor

    2011-09-01

    Full Text Available Abstract Background Despite the substantial progress in the quality of critical care, the incidence and mortality of acute kidney injury (AKI continues to rise during hospital admissions. We conducted a national, multicenter, prospective, epidemiological survey to evaluate the importance of AKI in intensive care units (ICUs in Hungary. The objectives of this study were to determine the incidence of AKI in ICU patients; to characterize the differences in aetiology, illness severity and clinical practice; and to determine the influencing factors of the development of AKI and the patients' outcomes. Methods We analysed the demographic, morbidity, treatment modality and outcome data of patients (n = 459 admitted to ICUs between October 1st, 2009 and November 30th, 2009 using a prospectively filled in electronic survey form in 7 representative ICUs. Results The major reason for ICU admission was surgical in 64.3% of patients and medical in the remaining 35.7%. One-hundred-twelve patients (24.4% had AKI. By AKIN criteria 11.5% had Stage 1, 5.4% had Stage 2 and 7.4% had Stage 3. In 44.0% of patients, AKI was associated with septic shock. Vasopressor treatment, SAPS II score, serum creatinine on ICU admission and sepsis were the independent risk factors for development of any stage of AKI. Among the Stage 3 patients (34 50% received renal replacement therapy. The overall utilization of intermittent renal replacement therapy was high (64.8%. The overall in-hospital mortality rate of AKI was 49% (55/112. The ICU mortality rate was 39.3% (44/112. The independent risk factors for ICU mortality were age, mechanical ventilation, SOFA score and AKI Stage 3. Conclusions For the first time we have established the incidence of AKI using the AKIN criteria in Hungarian ICUs. Results of the present study confirm that AKI has a high incidence and is associated with high ICU and in-hospital mortality.

  10. Multicenter results of stereotactic body radiotherapy (SBRT) for non-resectable primary liver tumors

    International Nuclear Information System (INIS)

    Background. An excess of 100 000 individuals are diagnosed with primary liver tumors every year in USA but less than 20% of those patients are amenable to definitive surgical management due to advanced local disease or comorbidities. Local therapies to arrest tumor growth have limited response and have shown no improvement on patient survival. Stereotactic body radiotherapy (SBRT) has emerged as an alternative local ablative therapy. The purpose of this study was to evaluate the tumor response to SBRT in a combined multicenter database. Study design. Patients with advanced hepatocellular carcinoma (HCC, n = 21) or intrahepatic cholangiocarcinoma (ICC, n = 11) treated with SBRT from four Academic Medical Centers were entered into a common database. Statistical analyses were performed for freedom from local progression (FFLP) and patient survival. Results. The overall FFLP for advanced HCC was 63% at a median follow-up of 12.9 months. Median tumor volume decreased from 334.2 to 135 cm3 (p < 0.004). The median time to local progression was 6.3 months. The 1- and 2-years overall survival rates were 87% and 55%, respectively. Patients with ICC had an overall FFLP of 55.5% at a median follow-up of 7.8 months. The median time to local progression was 4.2 months and the six-month and one-year overall survival rates were 75% and 45%, respectively. The incidence of grade 1-2 toxicities, mostly nausea and fatigue, was 39.5%. Grade 3 and 4 toxicities were present in two and one patients, respectively. Conclusion. Higher rates of FFLP were achieved by SBRT in the treatment of primary liver malignancies with low toxicity

  11. Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chen Yuan-Fang

    2013-01-01

    Full Text Available Abstract Background More than 70% of patients with depression who see their doctors experience insomnia. Insomnia treatment is a very important link for depression treatment. Furthermore, antidepression treatment is also important for depression insomnia. In acupuncture, LU-7 (Lie Que and KID-6 (Zhao Hai, which are two of the eight confluence points in meridian theory, are used as main points. An embedded needle technique is used, alternately, at two groups of points to consolidate the treatment effect. These two groups of points are BL-15 (Xin Shu with BL-23 (Shen Shu and BL-19 (Dan Shu with N-HN-54 (An Mian. The effectiveness of these optimized acupuncture formulas is well proven in the practice by our senior acupuncturists in Guangdong Provincial Hospital of TCM. This study has been designed to examine whether this set of optimized clinical formulas is able to increase the clinical efficacy of depression insomnia treatment. Methods/design In this randomized controlled multicenter trial, all the eligible participants are diagnosed with depression insomnia. All participants are randomly assigned to one of two groups in a ratio of 1:1 and receive either conventional acupuncture treatment or optimized acupuncture treatment. Patients are evaluated using the Pittsburgh Sleep Quality Index(PSQIand the Hamilton rating scale(HAMD for depression. The use of antidepression and hypnotics drugs is also considered. Results are obtained at the start of treatment, 1 and 2 months after treatment has begun, and at the end of treatment. The entire duration of the study will be approximately 36 months. Discussion A high quality of trial methodologies is utilized in the study, and the results may provide better evidence for the effectiveness of acupuncture as a treatment for depression insomnia. The optimized acupuncture formula has potential benefits in increasing the efficacy of treating depression insomnia. Trial registration The trial was registered in

  12. Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease—A Prospective, Multicenter Noninterventional Study

    Science.gov (United States)

    Scherer, Dieter; Krösser, Sonja; Beckert, Michael; Cursiefen, Claus; Kaercher, Thomas

    2015-01-01

    Abstract Purpose: Evaporation of the tear film is heavily discussed as one core reason for dry eye disease (DED). Subsequently, new artificial tear products are developed that specifically target this pathomechanism. Perfluorohexyloctane (F6H8, NovaTears®) from the family of semifluorinated alkanes is a novel substance that has been approved as a medical device, as a nonblurring wetting agent for the ocular surface. Methods: Thirty patients with hyperevaporative dry eye received F6H8 during a prospective, multicenter, observational 6-week study. Patients were advised to apply 1 drop 4 times daily in both eyes. Parameters assessed included best corrected visual acuity, intraocular pressure, Schirmer I test, tear fluid, tear film breakup time (TFBUT), corneal staining, meibum secretion, and Ocular Surface Disease Index (OSDI©). Results: From the 30 patients recruited, 25 completed the trial per protocol. Four patients discontinued F6H8 and 1 patient did not present for follow-up. F6H8 treatment led to significant reduction of corneal staining and significant increase of Schirmer I and TFBUT. In addition, OSDI score dropped significantly from a mean of 55 (±23.0) to 34 (±22.4). Visual acuity and ocular pressure did not change. Conclusions: This prospective observational study shows significant beneficial effects in patients suffering from evaporative DED, using F6H8 in all the relevant parameters tested. The decrease of the OSDI by a mean of 21 points was particularly remarkable and clearly exceeds minimal, clinical important differences for mild or moderate and severe disease. Overall, F6H8 (NovaTears) seems to be safe and effective in treating mild to moderate hyperevaporative DED. PMID:26296040

  13. Early-Stage Primary Bone Lymphoma: A Retrospective, Multicenter Rare Cancer Network (RCN) Study

    International Nuclear Information System (INIS)

    Purpose: Primary bone lymphoma (PBL) represents less than 1% of all malignant lymphomas. In this study, we assessed the disease profile, outcome, and prognostic factors in patients with Stages I and II PBL. Patients and Methods: Thirteen Rare Cancer Network (RCN) institutions enrolled 116 consecutive patients with PBL treated between 1987 and 2008 in this study. Eighty-seven patients underwent chemoradiotherapy (CXRT) without (78) or with (9) surgery, 15 radiotherapy (RT) without (13) or with (2) surgery, and 14 chemotherapy (CXT) without (9) or with (5) surgery. Median RT dose was 40 Gy (range, 4–60). The median number of CXT cycles was six (range, 2–8). Median follow-up was 41 months (range, 6–242). Results: The overall response rate at the end of treatment was 91% (complete response [CR] 74%, partial response [PR] 17%). Local recurrence or progression was observed in 12 (10%) patients and systemic recurrence in 17 (15%). The 5-year overall survival (OS), lymphoma-specific survival (LSS), and local control (LC) were 76%, 78%, and 92%, respectively. In univariate analyses (log–rank test), favorable prognostic factors for OS and LSS were International Prognostic Index (IPI) score ≤1 (p = 0.009), high-grade histology (p = 0.04), CXRT (p = 0.05), CXT (p = 0.0004), CR (p 40 Gy (p = 0.005). For LC, only CR and Stage I were favorable factors. In multivariate analysis, IPI score, RT dose, CR, and CXT were independently influencing the outcome (OS and LSS). CR was the only predicting factor for LC. Conclusion: This large multicenter retrospective study confirms the good prognosis of early-stage PBL treated with combined CXRT. An adequate dose of RT and complete CXT regime were associated with better outcome.

  14. Early-Stage Primary Bone Lymphoma: A Retrospective, Multicenter Rare Cancer Network (RCN) Study

    Energy Technology Data Exchange (ETDEWEB)

    Cai Ling [Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, VD (Switzerland); Sun Yat-sen University Cancer Center, Guangzhou, Guangdong (China); Stauder, Michael C. [Mayo Clinic, Rochester, MN (United States); Zhang Yujing [Sun Yat-sen University Cancer Center, Guangzhou, Guangdong (China); Poortmans, Philip [Verbeeten Institute, Tilburg (Netherlands); Li Yexiong [Cancer Hospital, Chinese Academy of Medical Sciences, Beijing (China); Constantinou, Nicolaos [Theagenio Cancer Hospital, Thessaloniki, Macedonia (Greece); Thariat, Juliette [Centre Anti-Cancereux Antoine-Lacassagne, Nice, Cote d' Azur (France); Kadish, Sidney P. [University of Massachusetts Medical School, Worcester, MA (United States); Nguyen, Tan Dat [Institut Jean-Godinot, Reims, Champagne-Ardenne (France); Kirova, Youlia M. [Institut Curie, Paris (France); Ghadjar, Pirus [Inselspital, Bern University Hospital, and University of Bern (Switzerland); Weber, Damien C. [Hopitaux Universitaires de Geneve (Switzerland); Bertran, Victoria Tuset [Hospital Universitari Germans Trias i Pujol, Barcelona (Spain); Ozsahin, Mahmut [Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, VD (Switzerland); Mirimanoff, Rene-Olivier, E-mail: Rene-Olivier.Mirimanoff@chuv.ch [Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, VD (Switzerland)

    2012-05-01

    Purpose: Primary bone lymphoma (PBL) represents less than 1% of all malignant lymphomas. In this study, we assessed the disease profile, outcome, and prognostic factors in patients with Stages I and II PBL. Patients and Methods: Thirteen Rare Cancer Network (RCN) institutions enrolled 116 consecutive patients with PBL treated between 1987 and 2008 in this study. Eighty-seven patients underwent chemoradiotherapy (CXRT) without (78) or with (9) surgery, 15 radiotherapy (RT) without (13) or with (2) surgery, and 14 chemotherapy (CXT) without (9) or with (5) surgery. Median RT dose was 40 Gy (range, 4-60). The median number of CXT cycles was six (range, 2-8). Median follow-up was 41 months (range, 6-242). Results: The overall response rate at the end of treatment was 91% (complete response [CR] 74%, partial response [PR] 17%). Local recurrence or progression was observed in 12 (10%) patients and systemic recurrence in 17 (15%). The 5-year overall survival (OS), lymphoma-specific survival (LSS), and local control (LC) were 76%, 78%, and 92%, respectively. In univariate analyses (log-rank test), favorable prognostic factors for OS and LSS were International Prognostic Index (IPI) score {<=}1 (p = 0.009), high-grade histology (p = 0.04), CXRT (p = 0.05), CXT (p = 0.0004), CR (p < 0.0001), and RT dose >40 Gy (p = 0.005). For LC, only CR and Stage I were favorable factors. In multivariate analysis, IPI score, RT dose, CR, and CXT were independently influencing the outcome (OS and LSS). CR was the only predicting factor for LC. Conclusion: This large multicenter retrospective study confirms the good prognosis of early-stage PBL treated with combined CXRT. An adequate dose of RT and complete CXT regime were associated with better outcome.

  15. Multicenter randomized trial of cell therapy in cardiopathies – MiHeart Study

    Directory of Open Access Journals (Sweden)

    Oliveira Sérgio A

    2007-01-01

    Full Text Available Abstract Background Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and more recently in clinical trials. Method/Design We have designed clinical trials to test for the efficacy of autologous bone marrow derived mononuclear cell therapies in four different cardiopathies: acute and chronic ischemic heart disease, and Chagasic and dilated cardiomyopathy. All trials are multicenter, randomized, double-blind and placebo controlled. In each trial 300 patients will be enrolled and receive optimized therapy for their specific condition. Additionally, half of the patients will receive the autologous bone marrow cells while the other half will receive placebo (saline with 5% autologous serum. For each trial there are specific inclusion and exclusion criteria and the method for cell delivery is intramyocardial for the chronic ischemic heart disease and intracoronary for all others. Primary endpoint for all studies will be the difference in ejection fraction (determined by Simpson's rule six and twelve months after intervention in relation to the basal ejection fraction. The main hypothesis of this study is that the patients who receive the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean increase of 5% in absolute left ventricular ejection fraction in comparison with the control group. Discussion Many phase I clinical trials using cell therapy for cardiac diseases have already been performed. The few randomized studies have yielded conflicting results, rendering necessary larger well controlled trials to test for efficacy of cell therapies in cardiopathies. The trials registration numbers at the NIH registry are the following: Chagasic cardiomyopathy (NCT00349271

  16. Written pain neuroscience education in fibromyalgia: a multicenter randomized controlled trial.

    Science.gov (United States)

    van Ittersum, Miriam W; van Wilgen, C Paul; van der Schans, Cees P; Lambrecht, Luc; Groothoff, Johan W; Nijs, Jo

    2014-11-01

    Mounting evidence supports the use of face-to-face pain neuroscience education for the treatment of chronic pain patients. This study aimed at examining whether written education about pain neuroscience improves illness perceptions, catastrophizing, and health status in patients with fibromyalgia. A double-blind, multicenter randomized controlled clinical trial with 6-month follow-up was conducted. Patients with FM (n = 114) that consented to participate were randomly allocated to receive either written pain neuroscience education or written relaxation training. Written pain neuroscience education comprised of a booklet with pain neuroscience education plus a telephone call to clarify any difficulties; the relaxation group received a booklet with relaxation education and a telephone call. The revised illness perception questionnaire, Pain Catastrophizing Scale, and fibromyalgia impact questionnaire were used as outcome measures. Both patients and assessors were blinded. Repeated-measures analyses with last observation carried forward principle were performed. Cohen's d effect sizes (ES) were calculated for all within-group changes and between-group differences. The results reveal that written pain neuroscience education does not change the impact of FM on daily life, catastrophizing, or perceived symptoms of patients with FM. Compared with written relaxation training, written pain neuroscience education improved beliefs in a chronic timeline of FM (P = 0.03; ES = 0.50), but it does not impact upon other domains of illness perceptions. Compared with written relaxation training, written pain neuroscience education slightly improved illness perceptions of patients with FM, but it did not impart clinically meaningful effects on pain, catastrophizing, or the impact of FM on daily life. Face-to-face sessions of pain neuroscience education are required to change inappropriate cognitions and perceived health in patients with FM. PMID:24251724

  17. Multicenter randomized trial of cell therapy in cardiopathies – MiHeart Study

    Science.gov (United States)

    Tura, Bernardo R; Martino, Helena F; Gowdak, Luis H; dos Santos, Ricardo Ribeiro; Dohmann, Hans F; Krieger, José E; Feitosa, Gilson; Vilas-Boas, Fábio; Oliveira, Sérgio A; Silva, Suzana A; Bozza, Augusto Z; Borojevic, Radovan; de Carvalho, Antonio C Campos

    2007-01-01

    Background Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and more recently in clinical trials. Method/Design We have designed clinical trials to test for the efficacy of autologous bone marrow derived mononuclear cell therapies in four different cardiopathies: acute and chronic ischemic heart disease, and Chagasic and dilated cardiomyopathy. All trials are multicenter, randomized, double-blind and placebo controlled. In each trial 300 patients will be enrolled and receive optimized therapy for their specific condition. Additionally, half of the patients will receive the autologous bone marrow cells while the other half will receive placebo (saline with 5% autologous serum). For each trial there are specific inclusion and exclusion criteria and the method for cell delivery is intramyocardial for the chronic ischemic heart disease and intracoronary for all others. Primary endpoint for all studies will be the difference in ejection fraction (determined by Simpson's rule) six and twelve months after intervention in relation to the basal ejection fraction. The main hypothesis of this study is that the patients who receive the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean increase of 5% in absolute left ventricular ejection fraction in comparison with the control group. Discussion Many phase I clinical trials using cell therapy for cardiac diseases have already been performed. The few randomized studies have yielded conflicting results, rendering necessary larger well controlled trials to test for efficacy of cell therapies in cardiopathies. The trials registration numbers at the NIH registry are the following: Chagasic cardiomyopathy (NCT00349271), dilated cardiomyopathy (NCT

  18. Estimating cardiovascular risk in patients with type 2 diabetes: a national multicenter study in Brazil

    Directory of Open Access Journals (Sweden)

    Gomes Marilia B

    2009-10-01

    Full Text Available Abstract According to Brazilian National Data Survey diabetes is the fifth cause for hospitalization and is one of the ten major causes of mortality in this country. Aims to stratify the estimated cardiovascular risk (eCVR in a population of type 2 diabetics (T2DM according to the Framingham prediction equations as well as to determine the association between eCVR with metabolic and clinical control of the disease. Methods From 2000 to 2001 a cross-sectional multicenter study was conducted in 13 public out-patients diabetes/endocrinology clinics from 8 Brazilian cities. The 10-year risk of developing coronary heart disease (CHD was estimated by the prediction equations described by Wilson et al (Circulation 1998. LDL equations were preferably used; when patients missed LDL data we used total cholesterol equations instead. Results Data from 1382 patients (59.0% female were analyzed. Median and inter-quartile range (IQ of age and duration of diabetes were 57.4 (51-65 and 8.8 (3-13 years, respectively without differences according to the gender. Forty-two percent of these patients were overweight and 35.4% were obese (the prevalence of higher BMI and obesity in this T2DM group was significantly higher in women than in men; p 20% in 738 (53.4%, intermediate in 202 (14.6% and low in 442 (32% patients. Men [25.1(15.4-37.3] showed a higher eCVR than women [18.8 (12.4-27.9 p

  19. Resection of spinal column tumors utilizing image-guided navigation: a multicenter analysis.

    Science.gov (United States)

    Nasser, Rani; Drazin, Doniel; Nakhla, Jonathan; Al-Khouja, Lutfi; Brien, Earl; Baron, Eli M; Kim, Terrence T; Patrick Johnson, J; Yassari, Reza

    2016-08-01

    OBJECTIVE The use of intraoperative stereotactic navigation has become more available in spine surgery. The authors undertook this study to assess the utility of intraoperative CT navigation in the localization of spinal lesions and as an intraoperative tool to guide resection in patients with spinal lesions. METHODS This was a retrospective multicenter study including 50 patients from 2 different institutions who underwent biopsy and/or resection of spinal column tumors using image-guided navigation. Of the 50 cases reviewed, 4 illustrative cases are presented. In addition, the authors provide a description of surgical technique with image guidance. RESULTS The patient group included 27 male patients and 23 female patients. Their average age was 61 ± 17 years (range 14-87 years). The average operative time (incision to closure) was 311 ± 188 minutes (range 62-865 minutes). The average intraoperative blood loss was 882 ± 1194 ml (range 5-7000 ml). The average length of hospitalization was 10 ± 8.9 days (range 1-36 days). The postoperative complications included 2 deaths (4.0%) and 4 radiculopathies (8%) secondary to tumor burden. CONCLUSIONS O-arm 3D imaging with stereotactic navigation may be used to localize lesions intraoperatively with real-time dynamic feedback of tumor resection. Stereotactic guidance may augment resection or biopsy of primary and metastatic spinal tumors. It offers reduced radiation exposure to operating room personnel and the ability to use minimally invasive approaches that limit tissue injury. In addition, acquisition of intraoperative CT scans with real-time tracking allows for precise targeting of spinal lesions with minimal dissection. PMID:27476839

  20. Transmission Assessment Surveys (TAS) to Define Endpoints for Lymphatic Filariasis Mass Drug Administration: A Multicenter Evaluation

    Science.gov (United States)

    Chu, Brian K.; Deming, Michael; Biritwum, Nana-Kwadwo; Bougma, Windtaré R.; Dorkenoo, Améyo M.; El-Setouhy, Maged; Fischer, Peter U.; Gass, Katherine; Gonzalez de Peña, Manuel; Mercado-Hernandez, Leda; Kyelem, Dominique; Lammie, Patrick J.; Flueckiger, Rebecca M.; Mwingira, Upendo J.; Noordin, Rahmah; Offei Owusu, Irene; Ottesen, Eric A.; Pavluck, Alexandre; Pilotte, Nils; Rao, Ramakrishna U.; Samarasekera, Dilhani; Schmaedick, Mark A.; Settinayake, Sunil; Simonsen, Paul E.; Supali, Taniawati; Taleo, Fasihah; Torres, Melissa; Weil, Gary J.; Won, Kimberly Y.

    2013-01-01

    Background Lymphatic filariasis (LF) is targeted for global elimination through treatment of entire at-risk populations with repeated annual mass drug administration (MDA). Essential for program success is defining and confirming the appropriate endpoint for MDA when transmission is presumed to have reached a level low enough that it cannot be sustained even in the absence of drug intervention. Guidelines advanced by WHO call for a transmission assessment survey (TAS) to determine if MDA can be stopped within an LF evaluation unit (EU) after at least five effective rounds of annual treatment. To test the value and practicality of these guidelines, a multicenter operational research trial was undertaken in 11 countries covering various geographic and epidemiological settings. Methodology The TAS was conducted twice in each EU with TAS-1 and TAS-2 approximately 24 months apart. Lot quality assurance sampling (LQAS) formed the basis of the TAS survey design but specific EU characteristics defined the survey site (school or community), eligible population (6–7 year olds or 1st–2nd graders), survey type (systematic or cluster-sampling), target sample size, and critical cutoff (a statistically powered threshold below which transmission is expected to be no longer sustainable). The primary diagnostic tools were the immunochromatographic (ICT) test for W. bancrofti EUs and the BmR1 test (Brugia Rapid or PanLF) for Brugia spp. EUs. Principal Findings/Conclusions In 10 of 11 EUs, the number of TAS-1 positive cases was below the critical cutoff, indicating that MDA could be stopped. The same results were found in the follow-up TAS-2, therefore, confirming the previous decision outcome. Sample sizes were highly sex and age-representative and closely matched the target value after factoring in estimates of non-participation. The TAS was determined to be a practical and effective evaluation tool for stopping MDA although its validity for longer-term post-MDA surveillance

  1. Effects of different weight loss intervention programmes in health clubs - an observational multicenter study.

    Science.gov (United States)

    Wanjek, Markus; Senner, Veit; Scharhag-Rosenberger, Friederike; Halle, Martin

    2016-10-01

    This study aimed at comparing the effectiveness of three lifestyle intervention programmes in health clubs "exercise only" (E), "exercise plus nutritional counselling" (E + NC), and "exercise plus weight loss program" (E + WLP) on weight loss under real-life conditions. An observational multicenter study including 788 overweight/obese new customers of 95 health clubs in Germany was performed. Participants chose E (n = 512, 38 ± 14 year, BMI 30.4 ± 4.7 kg/m(2)), E + NC (n = 179, 42 ± 14 year, BMI 31.7 ± 4.5 kg/m(2)), or E + WLP (n = 97, 40 ± 11 year, BMI 31.6 ± 5.1 kg/m(2)). Anthropometric data, energy expenditure, and energy intake were assessed at baseline and after 3 months. All groups significantly reduced body weight (E: -1.5 ± 2.9 kg, E + NC: -3.4 ± 3.6 kg, E + WLP: -5.5 ± 4.3 kg, p Exercise energy expenditure increased and energy intake decreased significantly in all groups (p exercise plus dietary interventions are more effective for weight loss than exercise alone. The benefits of E + WLP emphasize that interventions even performed by health clubs may elicit clinically relevant weight loss in overweight and obese new customers and can therefore be recommended. PMID:26835870

  2. DICOM for Clinical Research: PACS-Integrated Electronic Data Capture in Multi-Center Trials.

    Science.gov (United States)

    Haak, Daniel; Page, Charles-E; Reinartz, Sebastian; Krüger, Thilo; Deserno, Thomas M

    2015-10-01

    Providing surrogate endpoints in clinical trials, medical imaging has become increasingly important in human-centered research. Nowadays, electronic data capture systems (EDCS) are used but binary image data is integrated insufficiently. There exists no structured way, neither to manage digital imaging and communications in medicine (DICOM) data in EDCS nor to interconnect EDCS with picture archiving and communication systems (PACS). Manual detours in the trial workflow yield errors, delays, and costs. In this paper, requirements for a DICOM-based system interconnection of EDCS and research PACS are analysed. Several workflow architectures are compared. Optimized for multi-center trials, we propose an entirely web-based solution integrating EDCS, PACS, and DICOM viewer, which has been implemented using the open source projects OpenClinica, DCM4CHEE, and Weasis, respectively. The EDCS forms the primary access point. EDCS to PACS interchange is integrated seamlessly on the data and the context levels. DICOM data is viewed directly from the electronic case report form (eCRF), while PACS-based management is hidden from the user. Data privacy is ensured by automatic de-identification and re-labelling with study identifiers. Our concept is evaluated on a variety of 13 DICOM modalities and transfer syntaxes. We have implemented the system in an ongoing investigator-initiated trial (IIT), where five centers have recruited 24 patients so far, performing decentralized computed tomography (CT) screening. Using our system, the chief radiologist is reading DICOM data directly from the eCRF. Errors and workflow processing time are reduced. Furthermore, an imaging database is built that may support future research. PMID:26001521

  3. Factors influencing survival outcome for radiotherapy for biliary tract cancer: A multicenter retrospective study

    International Nuclear Information System (INIS)

    Purpose: To seek for the possible factors influencing overall survival (OS) with radiotherapy (RT) for biliary tract cancer. Materials and methods: Data were collected retrospectively from RT database of 31 institutions in Japan. All patients underwent at least external beam RT. The factors influencing OS were investigated. Results: Data of 498 patients were analyzed. Median OS of the 212 patients who underwent surgery was significantly better than that of the 286 patients without surgery (31 vs. 15 months, p < 0.001). The OS for the R0 or R1 resection group was significantly longer than that for the R2 or non-surgery group, as well as for n0 compared to n1 (all p < 0.001). Chemoradiotherapy (CRT), both sequential and concurrent, resulted in a better OS than RT alone for the n1 group (31 vs. 13 months, p < 0.001), and marginally better for the R0/R1 group (p = 0.065; p = 0.054 for concurrent CRT). However, no such benefit was observed for the R2/non-surgical patients. Multivariate analysis identified performance status, clinical stage, and surgery as significant factors. Conclusion: Surgery, especially R0/R1 resection, seemed as the gold standard for treatment of biliary tract cancer including RT, even in the highly heterogeneous population obtained from the multicenter retrospective study. The possibility was shown that CRT yielded better survival benefit especially for n1 patients. We recommend that future prospective trials include an arm of adjuvant CRT at least for n1 and possibly R0/R1 patients

  4. Noncutaneous malignant melanoma: a prognostic model from a retrospective multicenter study

    Directory of Open Access Journals (Sweden)

    Kim Jung Han

    2010-04-01

    Full Text Available Abstract Background We performed multicenter study to define clinical characteristics of noncutaneous melanomas and to establish prognostic factors patients who received curative resection. Methods Of the 141 patients who were diagnosed of non-cutaneous melanoma at 4 institutions in Korea between June 1992 and May 2005, 129 (91.5% satisfied the selection criteria. Results Of the 129 noncutaneous melanoma patients, 14 patients had ocular melanoma and 115 patients had mucosal melanoma. For mucosal melanoma, anorectum was the most common anatomic site (n = 39, 30.2% which was followed by nasal cavity (n = 30, 23.3%, genitourinary (n = 21, 16.3%, oral cavity (n = 14, 10.9%, upper gastrointestinal tract (n = 6, 4.7% and maxillary sinus (n = 5, 3.9% in the order of frequency. With the median 64.5 (range 4.3-213.0 months follow-up, the median overall survival were 24.4 months (95% CI 13.2-35.5 for all patients, and 34.6 (95% CI 24.5-44.7 months for curatively resected mucosal melanoma patients. Adverse prognostic factors of survival for 87 curatively resected mucosal melanoma patients were complete resection (R1 resection margin, and age > 50 years. For 14 ocular melanoma, Survival outcome was much better than mucosal melanoma with 73.3% of 2 year OS and 51.2 months of median OS (P = .04. Conclusion Prognosis differed according to primary sites of noncutaneous melanoma. Based on our study, noncutaneous melanoma patients should be treated differently to improve survival outcome.

  5. Prospective Multicenter Trial Evaluating Balloon-Catheter Partial-Breast Irradiation for Ductal Carcinoma in Situ

    International Nuclear Information System (INIS)

    Purpose: To determine outcomes of accelerated partial-breast irradiation (APBI) with MammoSite in the treatment of ductal carcinoma in situ (DCIS) after breast-conserving surgery. Methods and Materials: We conducted a prospective, multicenter trial between 2003 and 2009. Inclusion criteria included age >18 years, core needle biopsy diagnosis of DCIS, and no prior breast cancer history. Patients underwent breast-conserving surgery plus MammoSite placement. Radiation was given twice daily for 5 days for a total of 34 Gy. Patients were evaluated for development of toxicities, cosmetic outcome, and ipsilateral breast tumor recurrence (IBTR). Results: A total of 41 patients (42 breasts) completed treatment in the study, with a median follow up of 5.3 years. Overall, 28 patients (68.3%) experienced an adverse event. Skin changes and pain were the most common adverse events. Cosmetic outcome at 6 months was judged excellent/good by 100% of physicians and by 96.8% of patients. At 12 months, 86.7% of physicians and 92.3% of patients rated the cosmetic outcome as excellent/good. Overall, 4 patients (9.8%) developed an IBTR (all DCIS), with a 5-year actuarial rate of 11.3%. All IBTRs were outside the treatment field. Among patients with IBTRs, the mean time to recurrence was 3.2 years. Conclusions: Accelerated partial-breast irradiation using MammoSite seems to provide a safe and cosmetically acceptable outcome; however, the 9.8% IBTR rate with median follow-up of 5.3 years is concerning. Prospective randomized trials are necessary before routine use of APBI for DCIS can be recommended

  6. Prospective Multicenter Trial Evaluating Balloon-Catheter Partial-Breast Irradiation for Ductal Carcinoma in Situ

    Energy Technology Data Exchange (ETDEWEB)

    Abbott, Andrea M.; Portschy, Pamela R. [Division of Surgical Oncology, University of Minnesota, Minneapolis, Minnesota (United States); Lee, Chung [Department of Radiation Oncology, University of Minnesota, Minneapolis, Minnesota (United States); Le, Chap T. [Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota (United States); Han, Linda K. [Department of Surgery, Indiana University, Indianapolis, Indiana (United States); Washington, Tara [Vantage Oncology, Redhawk and Wildomar Centers California, Wildomar, California (United States); Kinney, Michael [Center for Advanced Breast Care, Arlington Heights, Illinois (United States); Bretzke, Margit [Surgical Specialists of Minnesota, Minneapolis, Minnesota (United States); Tuttle, Todd M., E-mail: tuttl006@umn.edu [Division of Surgical Oncology, University of Minnesota, Minneapolis, Minnesota (United States)

    2013-11-01

    Purpose: To determine outcomes of accelerated partial-breast irradiation (APBI) with MammoSite in the treatment of ductal carcinoma in situ (DCIS) after breast-conserving surgery. Methods and Materials: We conducted a prospective, multicenter trial between 2003 and 2009. Inclusion criteria included age >18 years, core needle biopsy diagnosis of DCIS, and no prior breast cancer history. Patients underwent breast-conserving surgery plus MammoSite placement. Radiation was given twice daily for 5 days for a total of 34 Gy. Patients were evaluated for development of toxicities, cosmetic outcome, and ipsilateral breast tumor recurrence (IBTR). Results: A total of 41 patients (42 breasts) completed treatment in the study, with a median follow up of 5.3 years. Overall, 28 patients (68.3%) experienced an adverse event. Skin changes and pain were the most common adverse events. Cosmetic outcome at 6 months was judged excellent/good by 100% of physicians and by 96.8% of patients. At 12 months, 86.7% of physicians and 92.3% of patients rated the cosmetic outcome as excellent/good. Overall, 4 patients (9.8%) developed an IBTR (all DCIS), with a 5-year actuarial rate of 11.3%. All IBTRs were outside the treatment field. Among patients with IBTRs, the mean time to recurrence was 3.2 years. Conclusions: Accelerated partial-breast irradiation using MammoSite seems to provide a safe and cosmetically acceptable outcome; however, the 9.8% IBTR rate with median follow-up of 5.3 years is concerning. Prospective randomized trials are necessary before routine use of APBI for DCIS can be recommended.

  7. Healthcare-associated infections and Shanghai clinicians: a multicenter cross-sectional study.

    Directory of Open Access Journals (Sweden)

    Yunfang Zhou

    Full Text Available Literature about healthcare-associated infection (HCAI in China is scarce. A cross-sectional anonymous survey was conducted on 647 clinicians (199 physicians and 448 nurses from six Shanghai hospitals (grades A-C to investigate their cognizance, knowledge, attitude, self-reported practice, and risks regarding HCAI with emphasis on precautions. The mean overall score of HCAI knowledge was 40.89±11.4 (mean±SD; range, 13∼72 out of 100 for physicians and 43.48±9.9 (10∼70 for nurses. The respondents generally received high scores in hand hygiene, HCAI core concept, and healthcare worker safety but low scores in HCAI pathogen identification and isolation precautions. There were substantial variations in the knowledge scores of various demographic groups across individual hospitals and within hospital grades (ps<0.05. Within-hospital comparisons showed that the nurses were better than physicians particularly in hand hygiene knowledge in 4 hospitals (ps<0.05. Multiple linear regression analysis showed that longer work experience was inversely and independently associated with the overall and categorical knowledge of nurses, whereas independent associations between older age or higher education and categorical knowledge were noted for physicians. The respondents' self-reported practices and adherence to standard precautions were less than satisfactory. This multi-center study reports a high level of cognizance, patchy knowledge, suboptimal adherence to infection control precautions, and self-protective attitudes among the practicing clinicians regarding HCAI, with potential safety risk to patients and healthcare providers. Providing quality learning resources, enforcing knowledge-informed practice, and promoting a healthcare safety culture are recommended as interventions. Future studies are warranted for social and behavioral aspects of healthcare safety with emphasis on infection control.

  8. Diagnostic accuracy of the Eurotest for dementia: a naturalistic, multicenter phase II study

    Directory of Open Access Journals (Sweden)

    Frank Ana

    2006-04-01

    Full Text Available Abstract Background Available screening tests for dementia are of limited usefulness because they are influenced by the patient's culture and educational level. The Eurotest, an instrument based on the knowledge and handling of money, was designed to overcome these limitations. The objective of this study was to evaluate the diagnostic accuracy of the Eurotest in identifying dementia in customary clinical practice. Methods A cross-sectional, multi-center, naturalistic phase II study was conducted. The Eurotest was administered to consecutive patients, older than 60 years, in general neurology clinics. The patients' condition was classified as dementia or no dementia according to DSM-IV diagnostic criteria. We calculated sensitivity (Sn, specificity (Sp and area under the ROC curves (aROC with 95% confidence intervals. The influence of social and educational factors on scores was evaluated with multiple linear regression analysis, and the influence of these factors on diagnostic accuracy was evaluated with logistic regression. Results Sixteen neurologists recruited a total of 516 participants: 101 with dementia, 380 without dementia, and 35 who were excluded. Of the 481 participants who took the Eurotest, 38.7% were totally or functionally illiterate and 45.5% had received no formal education. Mean time needed to administer the test was 8.2+/-2.0 minutes. The best cut-off point was 20/21, with Sn = 0.91 (0.84–0.96, Sp = 0.82 (0.77–0.85, and aROC = 0.93 (0.91–0.95. Neither the scores on the Eurotest nor its diagnostic accuracy were influenced by social or educational factors. Conclusion This naturalistic and pragmatic study shows that the Eurotest is a rapid, simple and useful screening instrument, which is free from educational influences, and has appropriate internal and external validity.

  9. Albumin Administration in Acute Ischemic Stroke: Safety Analysis of the ALIAS Part 2 Multicenter Trial.

    Directory of Open Access Journals (Sweden)

    Michael D Hill

    Full Text Available Albumin treatment of ischemic stroke was associated with cardiopulmonary adverse events in previous studies and a low incidence of intracranial hemorrhage. We sought to describe the neurological and cardiopulmonary adverse events in the ALIAS Part 2 Multicenter Trial.Ischemic stroke patients, aged 18-83 and a baseline NIHSS ≥ 6, were randomized to treatment with ALB or saline control within 5 hours of stroke onset. Neurological adverse events included symptomatic intracranial hemorrhage, hemicraniectomy, neurological deterioration and neurological death. Cardiopulmonary adverse events included pulmonary edema/congestive heart failure, acute coronary syndromes, atrial fibrillation, pneumonia and pulmonary thromboembolism.Among 830 patients, neurological and cardiopulmonary adverse events were not differentially associated with poor outcome between ALB and saline control subjects. The rate of symptomatic intracranial hemorrhage in the first 24h was low overall (2.9%, 24/830 but more common in the ALB treated subjects (RR = 2.4, CI95 1.01-5.8. The rate of pulmonary edema/CHF in the first 48h was 7.9% (59/830 and was more common among ALB treated subjects (RR = 10.7, CI95 4.3-26.6; this complication was expected and was satisfactorily managed with mandated diuretic administration and intravenous fluid guidelines. Troponin elevations in the first 48h were common, occurring without ECG change or cardiac symptoms in 52 subjects (12.5%.ALB therapy was associated with an increase in symptomatic ICH and pulmonary edema/congestive heart failure but this did not affect final outcomes. Troponin elevation occurs routinely in the first 48 hours after acute ischemic stroke.ClincalTrials.gov NCT00235495.

  10. Endoscopic ultrasound elastography for evaluation of lymph nodes and pancreatic masses: A multicenter study

    Institute of Scientific and Technical Information of China (English)

    Marc Giovannini; Botelberge Thomas; Bories Erwan; Pesenti Christian; Caillol Fabrice; Esterni Benjamin; Monges Geneviève; Arcidiacono Paolo; Deprez Pierre; Yeung Robert; Schimdt Walter; Schrader Hanz; Szymanski Carl; Dietrich Christoph; Eisendrath Pierre; Van Laethem Jean-Luc; Devière Jacques; Vilmann Peter; Saftoiu Andrian

    2009-01-01

    AIM: To evaluate the ability of endoscopic ultrasound (EUS) elastography to distinguish benign from malignant pancreatic masses and lymph nodes. METHODS: A multicenter study was conducted and included 222 patients who underwent EUS examination with assessment of a pancreatic mass ( n = 121) or lymph node ( n = 101). The classification as benign or malignant, based on the real time elastography pattern, was compared with the classification based on the B-mode EUS images and with the final diagnosis obtained by EUS-guided fine needle aspiration (EUSFNA) and/or by surgical pathology. An interobserver study was performed. RESULTS: The sensitivity and specificity of EUS elastography to differentiate benign from malignant pancreatic lesions are 92.3% and 80.0%, respectively, compared to 92.3% and 68.9%, respectively, for the conventional B-mode images. The sensitivity and specificity of EUS elastography to differentiate benign from malignant lymph nodes was 91.8% and 82.5%, respectively, compared to 78.6% and 50.0%, respectively, for the B-mode images. The kappa coefficient was 0.785 for the pancreatic masses and 0.657 for the lymph nodes. CONCLUSION: EUS elastography is superior compared to conventional B-mode imaging and appears to be able to distinguish benign from malignant pancreatic masses and lymph nodes with a high sensitivity, specificity and accuracy. It might be reserved as a second line examination to help characterise pancreatic masses after negative EUS-FNA and might increase the yield of EUS-FNA for lymph nodes.

  11. Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B

    Directory of Open Access Journals (Sweden)

    Reinaldo Menezes Martins

    2004-12-01

    Full Text Available The immunogenicity and safety of a new recombinant hepatitis B vaccine from the Instituto Butantan (Butang® were evaluated in a multicenter, double-blind, prospective equivalence study in three centers in Brazil. Engerix B® was the standard vaccine. A total of 3937 subjects were recruited and 2754 (70% met all protocol criteria at the end of the study. All the subjects were considered healthy and denied having received hepatitis B vaccine before the study. Study subjects who adhered to the protocol were newborn infants (566, children 1 to 10 years old (484, adolescents from 11 to 19 years (740, adults from 20 to 30 years (568, and adults from 31 to 40 years (396. Vaccine was administered in three doses on the schedule 0, 1, and 6 months (newborn infants, adolescents, and adults or 0, 1, and 7 months (children. Vaccine dose was intramuscular 10 µg (infants, children, and adolescents or 20 µg (adults. Percent seroprotection (assumed when anti-HBs titers were > 10mIU/ml and geometric mean titer (mIU/ml were: newborn infants, 93.7% and 351.1 (Butang® and 97.5% and 1530.6 (Engerix B®; children, 100% and 3600.0 (Butang® and 97.7% and 2753.1 (Engerix B®; adolescents, 95.1% and 746.3 (Butang® and 96% and 1284.3 (Engerix B®; adults 20-30 years old, 91.8% and 453.5 (Butang® and 95.5% and 1369.0 (Engerix B®; and adults 31-40 years old, 79.8% and 122.7 (Butang® and 92.4% and 686.2 (Engerix B®. There were no severe adverse events following either vaccine. The study concluded that Butang® was equivalent to Engerix B® in children, and less immunogenic but acceptable for use in newborn infants, adolescents, and young adults.

  12. A multicenter, cross-platform clinical validation study of cancer cytogenomic arrays.

    Science.gov (United States)

    Li, Marilyn M; Monzon, Federico A; Biegel, Jaclyn A; Jobanputra, Vaidehi; Laffin, Jennifer J; Levy, Brynn; Leon, Annette; Miron, Patricia; Rossi, Michael R; Toruner, Gokce; Alvarez, Karla; Doho, Gregory; Dougherty, Margaret J; Hu, Xiaofeng; Kash, Shera; Streck, Deanna; Znoyko, Iya; Hagenkord, Jill M; Wolff, Daynna J

    2015-11-01

    Cytogenomic microarray analysis (CMA) offers high resolution, genome-wide copy number information and is widely used in clinical laboratories for diagnosis of constitutional abnormalities. The Cancer Genomics Consortium (CGC) conducted a multiplatform, multicenter clinical validation project to compare the reliability and inter- and intralaboratory reproducibility of this technology for clinical oncology applications. Four specimen types were processed on three different microarray platforms-from Affymetrix, Agilent, and Illumina. Each microarray platform was employed at two independent test sites. The results were compared in a blinded manner with current standard methods, including karyotype, FISH, or morphology. Twenty-nine chronic lymphocytic leukemia blood, 34 myelodysplastic syndrome bone marrow, and 30 fresh frozen renal epithelial tumor samples were assessed by all six laboratories. Thirty formalin fixed paraffin embedded renal tumor samples were analyzed at the Affymetrix and Agilent test sites only. All study samples were initial diagnostic samples. Array data were analyzed at each participating site and were submitted to caArray for central analysis. Laboratory interpretive results were submitted to the central analysis team for comparison with the standard-of-care assays and for calculation of intraplatform reproducibility and cross-platform concordance. The results demonstrated that the three microarray platforms 1) detect clinically actionable genomic changes in cancer compatible to standard-of-care methods; 2) further define cytogenetic aberrations; 3) identify submicroscopic alterations and loss of heterozygosity (LOH); and 4) yield consistent results within and between laboratories. Based on this study, the CGC concludes that CMA is a sensitive and reliable technique for copy number and LOH assessment that may be used for clinical oncology genomic analysis. PMID:26454669

  13. Common Strategy for Adult and Pediatric Medulloblastoma: A Multicenter Series of 253 Adults

    International Nuclear Information System (INIS)

    Purpose: To assess prognostic factors for adults with medulloblastoma in a multicenter, retrospective study. Methods and Materials: Data were collected by file review or mail inquiry for 253 adults treated between 1975 to 2004. Radiologists or surgeons assessed disease characteristics, such as volume and extension. Patients were classified as having either high- or standard-risk disease. Prognostic factors were analyzed. Results: Median patient age was 29 years. Median follow-up was 7 years. Radiotherapy was delivered in 246 patients and radiochemotherapy in 142. Seventy-four patients relapsed. Respective 5- and 10-year overall survival rates were 72% and 55%. Univariate analysis showed that survival significantly correlated with metastasis, postsurgical performance status, brainstem involvement, involvement of the floor of the fourth ventricle (V4), and radiation dose to the spine and to the posterior cerebral fossa (PCF). By multivariate analysis, brainstem, V4 involvement, and dose to the PCF were negative prognostic factors. In the standard-risk subgroup there was no overall survival difference between patients treated with axial doses of ≥34 Gy and patients treated with craniospinal doses <34 Gy plus chemotherapy. Conclusion: We report the largest series of medulloblastoma in adults. Prognostic factors were similar to those observed in children. Results suggest that patients with standard-risk disease could be treated with radiochemotherapy, reducing doses to the craniospinal area, maintaining at least 50 Gy to the PCF. The role of chemotherapy for this group is still unclear. A randomized study should be performed to confirm these results, but because frequency is very low, such a study would be difficult

  14. Association of Fetal Abdominal–Head Circumference Size Difference With Shoulder Dystocia: A Multicenter Study

    Directory of Open Access Journals (Sweden)

    Loraine Endres

    2015-10-01

    Full Text Available Objective - This study aims to determine if shoulder dystocia is associated with a difference in the fetal abdominal (AC to head circumference (HC of 50 mm or more noted on antenatal ultrasound. Study Design - A multicenter matched case–control study was performed comparing women who had shoulder dystocia to controls who did not. Women with vaginal births of live born nonanomalous singletons ≥ 36 weeks of gestation with an antenatal ultrasound within 4 weeks of delivery were included. Controls were matched for gestational age, route of delivery, and diabetes status. Results - We identified 181 matched pairs. Only 5% of the fetuses had an AC to HC of ≥ 50 mm. The proportion of AC to HC difference of ≥ 50 mm was significantly higher in shoulder dystocia cases (8% than controls (1%, p = 0.002. With multivariate regression, the three significant factors associated with shoulder dystocia were AC to HC ≥ 50 mm (odds ratio [OR], 7.3; confidence interval [CI], 1.6–33.3; p = 0.010, femur length (OR, 1.1; CI, 1.0–1.2; p = 0.002, and induced labor (OR, 1.8; CI, 1.1–3.1; p = 0.027. Conclusion - A prenatal ultrasound finding of a difference in AC to HC of ≥ 50 mm while uncommon is associated with shoulder dystocia.

  15. The Multi-Center Airborne Coherent Atmospheric Wind Sensor: Recent Measurements and Future Applications

    Science.gov (United States)

    Rothermel, Jeffry; Cutten, Dean R.; Hardesty, R. Michael; Howell, James N.; Darby, Lisa S.; Tratt, David M.; Menzies, Robert T.

    1999-01-01

    The coherent Doppler lidar, when operated from an airborne platform, offers a unique measurement capability for study of atmospheric dynamical and physical properties. This is especially true for scientific objectives requiring measurements in optically-clear air, where other remote sensing technologies such as Doppler radar are at a disadvantage in terms of spatial resolution and coverage. Recent experience suggests airborne coherent Doppler lidar can yield unique wind measurements of--and during operation within--extreme weather phenomena. This paper presents the first airborne coherent Doppler lidar measurements of hurricane wind fields. The lidar atmospheric remote sensing groups of National Aeronautics and Space Administration (NASA) Marshall Space Flight Center, National Oceanic and Atmospheric Administration (NOAA) Environmental Technology Laboratory, and Jet Propulsion Laboratory jointly developed an airborne lidar system, the Multi-center Airborne Coherent Atmospheric Wind Sensor (MACAWS). The centerpiece of MACAWS is the lidar transmitter from the highly successful NOAA Windvan. Other field-tested lidar components have also been used, when feasible, to reduce costs and development time. The methodology for remotely sensing atmospheric wind fields with scanning coherent Doppler lidar was demonstrated in 1981; enhancements were made and the system was reflown in 1984. MACAWS has potentially greater scientific utility, compared to the original airborne scanning lidar system, owing to a factor of approx. 60 greater energy-per-pulse from the NOAA transmitter. MACAWS development was completed and the system was first flown in 1995. Following enhancements to improve performance, the system was re-flown in 1996 and 1998. The scientific motivation for MACAWS is three-fold: obtain fundamental measurements of subgrid scale (i.e., approx. 2-200 km) processes and features which may be used to improve parameterizations in hydrological, climate, and general

  16. Multicenter Evaluation of Clinical Diagnostic Methods for Detection and Isolation of Campylobacter spp. from Stool.

    Science.gov (United States)

    Fitzgerald, Collette; Patrick, Mary; Gonzalez, Anthony; Akin, Joshua; Polage, Christopher R; Wymore, Kate; Gillim-Ross, Laura; Xavier, Karen; Sadlowski, Jennifer; Monahan, Jan; Hurd, Sharon; Dahlberg, Suzanne; Jerris, Robert; Watson, Renee; Santovenia, Monica; Mitchell, David; Harrison, Cassandra; Tobin-D'Angelo, Melissa; DeMartino, Mary; Pentella, Michael; Razeq, Jafar; Leonard, Celere; Jung, Carrianne; Achong-Bowe, Ria; Evans, Yaaqobah; Jain, Damini; Juni, Billie; Leano, Fe; Robinson, Trisha; Smith, Kirk; Gittelman, Rachel M; Garrigan, Charles; Nachamkin, Irving

    2016-05-01

    The use of culture-independent diagnostic tests (CIDTs), such as stool antigen tests, as standalone tests for the detection of Campylobacter in stool is increasing. We conducted a prospective, multicenter study to evaluate the performance of stool antigen CIDTs compared to culture and PCR for Campylobacter detection. Between July and October 2010, we tested 2,767 stool specimens from patients with gastrointestinal illness with the following methods: four types of Campylobacter selective media, four commercial stool antigen assays, and a commercial PCR assay. Illnesses from which specimens were positive by one or more culture media or at least one CIDT and PCR were designated "cases." A total of 95 specimens (3.4%) met the case definition. The stool antigen CIDTs ranged from 79.6% to 87.6% in sensitivity, 95.9 to 99.5% in specificity, and 41.3 to 84.3% in positive predictive value. Culture alone detected 80/89 (89.9% sensitivity) Campylobacter jejuni/Campylobacter coli-positive cases. Of the 209 noncases that were positive by at least one CIDT, only one (0.48%) was positive by all four stool antigen tests, and 73% were positive by just one stool antigen test. The questionable relevance of unconfirmed positive stool antigen CIDT results was supported by the finding that noncases were less likely than cases to have gastrointestinal symptoms. Thus, while the tests were convenient to use, the sensitivity, specificity, and positive predictive value of Campylobacter stool antigen tests were highly variable. Given the relatively low incidence of Campylobacter disease and the generally poor diagnostic test characteristics, this study calls into question the use of commercially available stool antigen CIDTs as standalone tests for direct detection of Campylobacter in stool. PMID:26962088

  17. Vitamin D Deficiency in Iran: A Multi-center Study among Different Urban Areas

    Directory of Open Access Journals (Sweden)

    R Heshmat

    2008-11-01

    Full Text Available "nBackground: Recent studies have reported different prevalence of vitamin D deficiency in different sex and age groups in de­veloping countries. In the present survey, we elucidated the prevalence of vitamin D deficiency in a multi-center study among Iranian population. "nMethods: In a random cluster sample of healthy men and women (ranged 20 to 69 years old, a number of 5232 subjects from five urban metropolitans' cities (Tehran, Tabriz, Mashhad, Shiraz and Booshehr were recruited in 2001. Fasting blood sam­ple was taken from participants and sent to the laboratory for measurement of 25-hydroxy vitamin D level. Meta-analy­sis was performed using fixed effect method for estimation of vitamin D deficiency prevalence in a national level.      "nResults: Moderate to severe vitamin D deficiency was estimated in urban areas (except for Booshehr because of its heterogene­ity equal to 47.2, 45.7 and 44.2% in age groups of <50, 50-60 and 60≤ years, respectively among men and 54.2, 41.2 and 37.5 percent among women in the same age groups. The highest prevalence of moderate to severe vitamin D defi­ciency in men was observed in Tehran. Mashhad and Booshehr had also the lowest prevalence of moderate to severe vita­min D deficiency among men and women."nConclusion: Iran is a country with high prevalence of moderate to severe vitamin D deficiency and the prevalence of this defi­ciency is more evident in Tehran, capital of Iran. Therefore, consideration of main predictors for vitamin D deficiency in all age groups especially in Tehran is recommended.   

  18. Application of continuous positive airway pressure in the delivery room: a multicenter randomized clinical trial

    Directory of Open Access Journals (Sweden)

    W.A. Goncalves-Ferri

    2014-03-01

    Full Text Available This study evaluated whether the use of continuous positive airway pressure (CPAP in the delivery room alters the need for mechanical ventilation and surfactant during the first 5 days of life and modifies the incidence of respiratory morbidity and mortality during the hospital stay. The study was a multicenter randomized clinical trial conducted in five public university hospitals in Brazil, from June 2008 to December 2009. Participants were 197 infants with birth weight of 1000-1500 g and without major birth defects. They were treated according to the guidelines of the American Academy of Pediatrics (APP. Infants not intubated or extubated less than 15 min after birth were randomized for two treatments, routine or CPAP, and were followed until hospital discharge. The routine (n=99 and CPAP (n=98 infants studied presented no statistically significant differences regarding birth characteristics, complications during the prenatal period, the need for mechanical ventilation during the first 5 days of life (19.2 vs 23.4%, P=0.50, use of surfactant (18.2 vs 17.3% P=0.92, or respiratory morbidity and mortality until discharge. The CPAP group required a greater number of doses of surfactant (1.5 vs 1.0, P=0.02. When CPAP was applied to the routine group, it was installed within a median time of 30 min. We found that CPAP applied less than 15 min after birth was not able to reduce the need for ventilator support and was associated with a higher number of doses of surfactant when compared to CPAP applied as clinically indicated within a median time of 30 min.

  19. Multicenter Clinical Study on the Treatment of Children's Tic Disorder with Qufeng Zhidong Recipe(祛风止动方)

    Institute of Scientific and Technical Information of China (English)

    吴敏; 肖光华; 姚敏; 张建明; 张欣; 周亚兵; 张婧延; 王树霞; 马博; 陈燕萍

    2009-01-01

    Objective:To assess the effect and adverse reaction of Qufeng Zhidong Recipe(袪风止动方, QZR)in treating children's tic disorder(TD).Methods:With multicenter randomized parallel open-controlled method adopted,the patients enrolled were assigned to two groups,41 cases in the Chinese medicine (CM)group and 40 in the Western medicine(WM)group.They were treated by QZR and haloperidol plus trihexyphenidyl respectively for 12 weeks as one course.In total,two courses of treatment were given.The curative effect and a...

  20. In vivo field dependence of proton relaxation times in human brain, liver and skeletal muscle: a multicenter study

    DEFF Research Database (Denmark)

    Henriksen, O; de Certaines, J D; Spisni, A; Cortsen, M; Muller, R N; Ring, P B

    1993-01-01

    T1 and T2 relaxation times are fundamental parameters for signal contrast behaviour in MRI. A number of ex vivo relaxometry studies have dealt with the magnetic field dispersion of T1. By means of multicenter study within the frame of the COMAC BME Concerted Action on Tissue Characterization by MRI...... and MRS, the in vivo field dispersion of T1 and T2 has been measured in order to evaluate whether ex vivo data are representative for the in vivo situation. Brain, skeletal muscle, and liver of healthy human volunteers were studied. Fifteen MR units with a field strength ranging from 0.08 T to 1.5 T...

  1. Multicenter Phase 2 Trial of Sirolimus for Tuberous Sclerosis: Kidney Angiomyolipomas and Other Tumors Regress and VEGF- D Levels Decrease

    OpenAIRE

    Dabora, Sandra L; Franz, David Neal; Ashwal, Stephen; Sagalowsky, Arthur; DiMario, Francis J.; Miles, Daniel; Cutler, Drew; Krueger, Darcy; Uppot, Raul N.; Rabenou, Rahmin; Camposano, Susana; Paolini, Jan; Fennessy, Fiona; Lee, Nancy; Woodrum, Chelsey

    2011-01-01

    Background Tuberous sclerosis (TSC) related tumors are characterized by constitutively activated mTOR signaling due to mutations in TSC1 or TSC2. Methods We completed a phase 2 multicenter trial to evaluate the efficacy and tolerability of the mTOR inhibitor, sirolimus, for the treatment of kidney angiomyolipomas. Results 36 adults with TSC or TSC/LAM were enrolled and started on daily sirolimus. The overall response rate was 44.4% (95% confidence intervals [CI] 28 to 61); 16/36 had a partial...

  2. Multicenter study comparing 0.05% gel formulations of desoximetasone and fluocinonide in patients with scalp psoriasis.

    Science.gov (United States)

    Willis, I; Cornell, R C; Penneys, N S; Zaias, N

    1986-01-01

    A double-blind, multicenter study was conducted to evaluate and compare the safety and efficacy of desoximetasone gel 0.05% and fluocinonide gel 0.05% in patients with scalp psoriasis. One hundred twenty-five patients were enrolled in this randomized, parallel-group trial. Responses based on clinical assessment in 123 patients showed that the desoximetasone gel formulation is a safe and effective treatment for psoriasis of the scalp. Although efficacy appears equivalent to that of fluocinonide gel 0.05% in treating psoriasis of the scalp, desoximetasone appears to be slightly better tolerated and better accepted cosmetically. PMID:3521856

  3. Virtual histology assessment of cardiac allograft vasculopathy following introduction of everolimus--results of a multicenter trial

    DEFF Research Database (Denmark)

    Arora, Stina Jørgensen; Erikstad, I; Ueland, T;

    2012-01-01

    In this 12-month multicenter Scandinavian study, 78 maintenance heart transplant (HTx) recipients randomized to everolimus with reduced calcineurin inhibitor (CNI) exposure or continued standard CNI-therapy underwent matched virtual histology (VH) examination to evaluate morphological progression...... of cardiac allograft vasculopathy (CAV). Parallel measurement of a range of inflammatory markers was also performed. A similar rate of quantitative CAV progression was observed in the everolimus (n = 30) and standard CNI group (n = 48) (plaque index 1.9 ± 3.8% and 1.6 ± 3.9%, respectively; p = 0...

  4. Graphical linking of MO multicenter bond index and VB structures. II-5-c rings and 6-c heterocyclic rings

    CERN Document Server

    Bollini, C G; Giambiagi, M

    2001-01-01

    Through the graphical method proposed it is possible to set a link between an MO multicenter bond index and VB structures. The value of the index depends on the order of the atoms involved if they are more than three. For 5-c rings three basic structures are required; the eventually different values are 12. Unlike the 6-c case it may happen that different pairs of basic structures are used to build the same polygon. For the 6-c rings including heteroatoms the original degeneracy of benzene splits leading eventually to 60 different I sub r sub i sub n sub g values.

  5. The QUASAR reproducibility study, Part II: Results from a multi-center Arterial Spin Labeling test-retest study

    DEFF Research Database (Denmark)

    Petersen, Esben Thade; Mouridsen, Kim; Golay, Xavier;

    2010-01-01

    metabolism. So far, ASL has been restricted mostly to specialist centers due to a generally low SNR of the method and potential issues with user-dependent analysis needed to obtain quantitative measurement of cerebral blood flow (CBF). Here, we evaluated a particular implementation of ASL (called...... total of 284 healthy volunteers were scanned. Minimal operator dependence was assured by using an automatic planning tool and its accuracy and potential usefulness in multi-center trials was evaluated as well. Accurate repositioning between sessions was achieved with the automatic planning tool showing...

  6. Effect of caffeine on SPECT myocardial perfusion imaging during regadenoson pharmacologic stress: a prospective, randomized, multicenter study

    OpenAIRE

    Tejani, Furqan H.; Thompson, Randall C.; Kristy, Rita; Bukofzer, Stan

    2014-01-01

    A multicenter, double-blind, randomized study was conducted to assess the effect of caffeine on regadenoson stress myocardial perfusion imaging (MPI). Subjects with a high likelihood of coronary artery disease underwent a rest single-photon emission computed tomography MPI on day 1 (MPI-1) and a stress MPI with regadenoson on day 3 (MPI-2). Individuals with ≥1 segment with a reversible defect received double-blind caffeine tablets (200 or 400 mg) or placebo 90 min before a repeat regadenoson ...

  7. Prognostic value of myocardial perfusion single photon emission computed tomography for major adverse cardiac cerebrovascular and renal events in patients with chronic kidney disease: results from first year of follow-up of the Gunma-CKD SPECT multicenter study

    International Nuclear Information System (INIS)

    Patients with chronic kidney disease (CKD) have an increased risk of adverse cardio-cerebrovascular events. We examined whether stress myocardial perfusion single photon emission computed tomography (SPECT) provides reliable prognostic markers for these patients. In this multicenter, prospective cohort trial from the Gunma-CKD SPECT study protocol, patients with CKD [estimated glomerular filtration rate (eGFR) < 60 min/ml per 1.73 m2] undergoing stress 99mTc-tetrofosmin SPECT for suspected or possible ischemic heart disease were initially followed for 1 year, with the following study endpoints: primary, the occurrence of cardiac deaths (CDs), and secondary, major adverse cardiac, cerebrovascular, and renal events (MACCREs). The summed stress score (SSS), summed rest score, and summed difference score (SDS) were estimated with the standard 17-segment, 5-point scoring model. Left ventricular end-diastolic volume, end-systolic volume (ESV), and ejection fraction were measured using electrocardiogram-gated SPECT. During the first year of follow-up, 69 of 299 patients experienced MACCREs (CD, n = 7; non-fatal myocardial infarction, n = 3; hospitalization for heart failure, n = 13; cerebrovascular accident, n = 1; need for revascularization, n = 38; and renal failure, i.e., hemodialysis initiation, n = 7). ESV and SSS were associated with CDs (p < 0.05), and eGFR and SDS were associated with MACCREs (p < 0.05), in multivariate logistic analysis. Patients with high ESV and high SSS had a significantly higher CD rate during the first year than the other CKD patient subgroups (p < 0.05). Patients with low eGFR and high SDS had a significantly higher MACCRE rate than the other subgroups (p < 0.05). Myocardial perfusion SPECT can provide reliable prognostic markers for patients with CKD. (orig.)

  8. Different thresholds for detecting osteophytes and joint space narrowing exist between the site investigators and the centralized reader in a multicenter knee osteoarthritis study - data from the Osteoarthritis Initiative

    International Nuclear Information System (INIS)

    To evaluate how the reading of knee radiographs by site investigators differs from that by an expert musculoskeletal radiologist who trained and validated them in a multicenter knee osteoarthritis (OA) study. A subset of participants from the Osteoarthritis Initiative progression cohort was studied. Osteophytes and joint space narrowing (JSN) were evaluated using Kellgren-Lawrence (KL) and Osteoarthritis Research Society International (OARSI) grading. Radiographs were read by site investigators, who received training and validation of their competence by an expert musculoskeletal radiologist. Radiographs were re-read by this radiologist, who acted as a central reader. For KL and OARSI grading of osteophytes, discrepancies between two readings were adjudicated by another expert reader. Radiographs from 96 subjects (49 women) and 192 knees (138 KL grade ≥ 2) were included. The site reading showed moderate agreement for KL grading overall (kappa=0.52) and for KL ≥ 2 (i.e., radiographic diagnosis of ''definite OA''; kappa=0.41). For OARSI grading, the site reading showed substantial agreement for lateral and medial JSN (kappa=0.65 and 0.71), but only fair agreement for osteophytes (kappa=0.37). For KL grading, the adjudicator's reading showed substantial agreement with the centralized reading (kappa=0.62), but only slight agreement with the site reading (kappa = 0.10). Site investigators over-graded osteophytes compared to the central reader and the adjudicator. Different thresholds for scoring of JSN exist even between experts. Our results suggest that research studies using radiographic grading of OA should use a centralized reader for all grading. (orig.)

  9. Combination of bendamustine and rituximab as front-line therapy for patients with chronic lymphocytic leukaemia: multicenter, retrospective clinical practice experience with 279 cases outside of controlled clinical trials.

    Science.gov (United States)

    Gentile, Massimo; Zirlik, Katja; Ciolli, Stefania; Mauro, Francesca R; Di Renzo, Nicola; Mastrullo, Lucia; Angrilli, Francesco; Molica, Stefano; Tripepi, Giovanni; Giordano, Annamaria; Di Raimondo, Francesco; Selleri, Carmine; Coscia, Marta; Musso, Maurizio; Orsucci, Lorella; Mannina, Donato; Rago, Angela; Giannotta, Angela; Ferrara, Felicetto; Herishanu, Yair; Shvidel, Lev; Tadmor, Tamar; Scortechini, Ilaria; Ilariucci, Fiorella; Murru, Roberta; Guarini, Attilio; Musuraca, Gerardo; Mineo, Giuseppe; Vincelli, Iolanda; Arcari, Annalisa; Tarantini, Giuseppe; Caparrotti, Giuseppe; Chiarenza, Annalisa; Levato, Luciano; Villa, Maria Rosaria; De Paolis, Maria Rosaria; Zinzani, Pier Luigi; Polliack, Aaron; Morabito, Fortunato

    2016-06-01

    Recently, encouraging results in terms of safety and efficacy have been obtained using bendamustine-rituximab (BR) in untreated chronic lymphocytic leukaemia (CLL) patients enrolled in a phase II study. Here, we report a retrospective international multicenter study of CLL patients treated with BR as front-line therapy. The cohort included 279 patients with progressive CLL from 33 centers (29 Italian, 3 Israeli and 1 German) who received at least 1 cycle of BR as first-line treatment during the 2008-2014 period. The primary objective of this study was to evaluate the efficacy and safety of BR administered as front-line therapy, outside of controlled clinical trials. Median age was 70 years (range, 43-86 years); 62.4% were males and 35.8% had Binet stage C. Forty-two patients (15.2%) were unfit (cumulative illness rating scale [CIRS] score ≥7), and 140 (50.2%) had creatinine clearance ≤70 ml/min. Fluorescent in situ hybridisation analysis, available for 192 cases, showed that 21 (10.9%) had del11q and 18 (9.4%) del17p. The overall response rate (ORR) was 86.4%, with a complete remission rate of 28%. Patients with del17p had an ORR of 66.7%. After median follow-up of 24 months, the 2-year progression-free survival (PFS) was 69.9%; CIRS ≥7, immunoglobulin heavy-chain variable-region (IGHV) unmutated status, del17p and BR dose intensity <80% were independently associated with shorter PFS. Grade III or IV neutropenia, thrombocytopenia, and anaemia were observed in 25.9%, 15.4%, and 15.1% of patients, respectively. Twenty-four patients (8.6%) had severe infections. BR is also an effective and safe regimen for untreated CLL patients, outside of controlled clinical trials. PMID:27127905

  10. Prognostic value of myocardial perfusion single photon emission computed tomography for major adverse cardiac cerebrovascular and renal events in patients with chronic kidney disease: results from first year of follow-up of the Gunma-CKD SPECT multicenter study

    Energy Technology Data Exchange (ETDEWEB)

    Kasama, Shu [Gunma University Graduate School of Medicine, Department of Medicine and Biological Science (Cardiovascular Medicine), Maebashi, Gunma (Japan); Cardiovascular Hospital of Central Japan (Kitakanto Cardiovascular Hospital), Department of Cardiovascular Medicine, Gunma (Japan); Toyama, Takuji [Department of Cardiovascular Medicine, Gunma Prefectural Cardiovascular Center, Maebashi (Japan); Sato, Makito [Gunma University Graduate School of Medicine, Department of Medicine and Biological Science (Cardiovascular Medicine), Maebashi, Gunma (Japan); Tatebayashi Kosei Hospital, Department of Internal Medicine, Gunma (Japan); Sano, Hirokazu [Gunma University Graduate School of Medicine, Department of Medicine and Biological Science (Cardiovascular Medicine), Maebashi, Gunma (Japan); Isesaki Municipal Hospital, Department of Cardiovascular Medicine, Isesaki (Japan); Ueda, Tetsuya [Fujioka General Hospital, Division of Cardiology, Fujioka (Japan); Sasaki, Toyoshi [Takasaki General Medical Center, Division of Cardiology, Takasaki (Japan); Nakahara, Takehiro; Kurabayashi, Masahiko [Gunma University Graduate School of Medicine, Department of Medicine and Biological Science (Cardiovascular Medicine), Maebashi, Gunma (Japan); Higuchi, Tetsuya; Tsushima, Yoshito [Gunma University Graduate School of Medicine, Department of Diagnostic Radiology and Nuclear Medicine, Maebashi (Japan)

    2016-02-15

    Patients with chronic kidney disease (CKD) have an increased risk of adverse cardio-cerebrovascular events. We examined whether stress myocardial perfusion single photon emission computed tomography (SPECT) provides reliable prognostic markers for these patients. In this multicenter, prospective cohort trial from the Gunma-CKD SPECT study protocol, patients with CKD [estimated glomerular filtration rate (eGFR) < 60 min/ml per 1.73 m{sup 2}] undergoing stress {sup 99m}Tc-tetrofosmin SPECT for suspected or possible ischemic heart disease were initially followed for 1 year, with the following study endpoints: primary, the occurrence of cardiac deaths (CDs), and secondary, major adverse cardiac, cerebrovascular, and renal events (MACCREs). The summed stress score (SSS), summed rest score, and summed difference score (SDS) were estimated with the standard 17-segment, 5-point scoring model. Left ventricular end-diastolic volume, end-systolic volume (ESV), and ejection fraction were measured using electrocardiogram-gated SPECT. During the first year of follow-up, 69 of 299 patients experienced MACCREs (CD, n = 7; non-fatal myocardial infarction, n = 3; hospitalization for heart failure, n = 13; cerebrovascular accident, n = 1; need for revascularization, n = 38; and renal failure, i.e., hemodialysis initiation, n = 7). ESV and SSS were associated with CDs (p < 0.05), and eGFR and SDS were associated with MACCREs (p < 0.05), in multivariate logistic analysis. Patients with high ESV and high SSS had a significantly higher CD rate during the first year than the other CKD patient subgroups (p < 0.05). Patients with low eGFR and high SDS had a significantly higher MACCRE rate than the other subgroups (p < 0.05). Myocardial perfusion SPECT can provide reliable prognostic markers for patients with CKD. (orig.)

  11. Does Low Participation in Cohort Studies Induce Bias?

    DEFF Research Database (Denmark)

    Nøhr, Ellen Aagaard; Frydenberg, Morten; Henriksen, Tine Brink; Olsen, Jørn

    2006-01-01

    confidence intervals gave very similar results and a small simulation study showed that the coverage probabilities were close to the 95% nominal level Conclusion: For the three chosen associations the odds ratios were not biased by non-participation. The results are reassuring for studies based on the Danish...... cohort and similar cohorts of pregnant women. The methodology used to compute confidence intervals for the relative odds ratios performed well in the scenarios considered.......Background: Participation rates in large cohort studies have dropped during the last two decades. The consequences of this trend for relative risk estimation are unknown. Methods: The impact of a low participation rate (30%) on the Danish National Birth Cohort was examined among 49,751 women from...

  12. Anxiety disorders and inflammation in a large adult cohort

    NARCIS (Netherlands)

    Vogelzangs, N.; Beekman, A. T. F.; de Jonge, P.; Penninx, Brenda

    2013-01-01

    Although anxiety disorders, like depression, are increasingly being associated with metabolic and cardiovascular burden, in contrast with depression, the role of inflammation in anxiety has sparsely been examined. This large cohort study examines the association between anxiety disorders and anxiety

  13. Breast and Prostate Cancer Cohort Consortium (BPC3)

    Science.gov (United States)

    Breast and Prostate Cancer Cohort Consortium collaborates with three genomic facilities, epidemiologists, population geneticists, and biostatisticians from multiple institutions to study hormone-related gene variants and environmental factors in breast and prostate cancers.

  14. European birth cohort studies on asthma and atopic diseases

    DEFF Research Database (Denmark)

    Keil, T; Kulig, M; Simpson, A;

    2006-01-01

    BACKGROUND: The reasons for the rise in asthma and allergies remain unclear. To identify risk or protective factors, it is essential to carry out longitudinal epidemiological studies, preferably birth cohort studies. In Europe, several birth cohort studies on asthma and atopic diseases have been...... initiated over the last two decades. AIM: One of the work packages within the Global Allergy and Asthma European Network (GA(2)LEN) project was designed to identify and compare European birth cohorts on asthma and atopic diseases. The present review (part I) describes their objectives, study settings......, recruitment process and follow-up rates. A subsequent review (part II) will compare outcome and exposure parameters. METHODS: For each birth cohort, we collected detailed information regarding recruitment process, study setting, baseline data (pregnancy, birth, parents/siblings) as well as follow-up rates...

  15. Impact of pediatric inflammatory bowel disease on linear growth: Data from a national cohort study in Saudi Arabia

    Directory of Open Access Journals (Sweden)

    Mohammad I El Mouzan

    2016-01-01

    Full Text Available Background/Aim: Linear growth impairment (LGI is one of the most important features peculiar to children with inflammatory bowel disease (IBD. The aim of this report is to define the impact of IBD on the linear growth of children in the Kingdom of Saudi Arabia (KSA. Setting and Design: Multicenter retrospective study. Patients and Methods: Data from a cohort of newly- diagnosed children with IBD from 2003 to 2012 were analyzed retrospectively. The diagnosis of IBD was confirmed in accordance with the published criteria. Length/height for age was measured at diagnosis. The World Health Organization (WHO reference was used and LGI was defined by length/height for age <-2 standard deviation. Chi-square test was used to test the significance of estimates and a P < 0.05 was considered significant. Results: There were 374 children from 0.33 to 16 years of age, including 119 ulcerative colitis (UC (32%, and 255 Crohn's disease (CD (68% patients. The prevalence of LGI was 26%, 28%, and 21% in IBD, CD, and UC, respectively. In children below 10 years, LGI was significantly more common in CD (P = 0.010, while in UC children, it was more common in older children (P = 0.011. Conclusion: This study demonstrates a prevalence of LGI consistent with that reported in the literature, but higher in CD children with early onset (<10 years and in older children with UC, underscoring the importance of monitoring growth in children with IBD in the Saudi population. Prospective studies are needed to define the impact of IBD on growth velocity, puberty, and final adult stature.

  16. Postponement and childlessness - Evidence from two British cohorts

    OpenAIRE

    Heather Joshi; Dylan Kneale

    2008-01-01

    This paper starts by reviewing existing projections of childlessness among British men and women. Low current fertility implies high eventual childlessness unless the postponement of parenthood is taken into account. Such re-timing of first births appears to be occurring differentially across social groups. Exploiting the disaggregated evidence of two British cohort studies, the 1958 National Child Development Study and the 1970 British Cohort Survey, this paper investigates the extent of pos...

  17. Work engagement and meaningful work across generational cohorts

    OpenAIRE

    Crystal Hoole; Jackie Bonnema

    2015-01-01

    Orientation: Engaging employees and providing employees with a sense of meaning at work is not a one-size-fits-all approach. Although research has shown that differences between work engagement and meaningful work amongst generational cohorts exist, results are still inconclusive. With age becoming increasingly more important as a diversity factor, a better understanding of the dynamics between work engagement and meaningful work across different generational cohorts is necessary to design t...

  18. Exposure Assessment in Cohort Studies of Childhood Asthma

    OpenAIRE

    Arrandale, Victoria H.; Brauer, Michael; Brook, Jeffrey R.; Brunekreef, Bert; Gold, Diane R.; London, Stephanie J.; Miller, J. David; Özkaynak, Halûk; Ries, Nola M.; Sears, Malcolm R; Silverman, Frances S.; Takaro, Tim K

    2010-01-01

    Background The environment is suspected to play an important role in the development of childhood asthma. Cohort studies are a powerful observational design for studying exposure–response relationships, but their power depends in part upon the accuracy of the exposure assessment. Objective The purpose of this paper is to summarize and discuss issues that make accurate exposure assessment a challenge and to suggest strategies for improving exposure assessment in longitudinal cohort studies of ...

  19. Survival Among Belgian Centenarians (1870-1894 Cohorts)

    OpenAIRE

    Liu Yuzhi; Zhang Chunyuan; Foulon, M.; D. Chambre; Poulain, M.

    2001-01-01

    Poulain Michel, Chambre Dany, Foulon Michel.- Survival Among Belgian Centenarians (1870-1894 Cohorts) Calculating the probability of dying among post-centenarians is problematic and often flawed by a high risk of error. This is partly due to the unreliability of statistical data on centenarians, and partly to the small populations concerned. The Belgian centenarian database of over 4,000 centenarians in the 1870 to 1894 birth cohorts used here endeavours to compensate for these two failings. ...

  20. The Natural History of Asthma in a Primary Care Cohort

    OpenAIRE

    Winkler Prins, V.; Nieuwenhof, L.J.L. van den; Hoogen, H.J.M. van den; Bor, J.H.J.; van Weel, C

    2004-01-01

    BACKGROUND: We examined the natural history of asthma in a primary care cohort of patients 10 years after the cohort was stratified for asthma risk by responses to a questionnaire and bronchial hyperresponsiveness (BHR) testing. METHODS: Children and young adults who were born between 1967 and 1979 within 1 of 4 affiliated family practices of the Nijmegen Department of Family Medicine, The Netherlands, were asked to participate in an asthma study in 1989. Of 926 patients available, 581 (63%) ...

  1. A Cohort Analysis of Household Saving in Norway

    OpenAIRE

    2003-01-01

    Are there generational differences in saving behavior? On the basis of new micro data for household saving in Norway I find that differences between birth cohorts are small and statistically insignificant. In particular, cohort effects are small compared to the strong positive effect of aging on saving. Furthermore, within the framework of a life-cycle model, a generation that is characterized as being particularly patient or prudent will save more while young and less while old, a result tha...

  2. Practical survival analysis tools for heterogeneous cohorts and informative censoring

    OpenAIRE

    Rowley, M; Garmo, H; Van Hemelrijck, M; Wulaningsih, W.; Grundmark, B.; Zethelius, B.; Hammar, N.; Walldius, G; M. Inoue; Holmberg, L; Coolen, A. C. C.

    2015-01-01

    In heterogeneous cohorts and those where censoring by non-primary risks is informative many conventional survival analysis methods are not applicable; the proportional hazards assumption is usually violated at population level and the observed crude hazard rates are no longer estimators of what they would have been in the absence of other risks. In this paper, we develop a fully Bayesian survival analysis to determine the probabilistically optimal description of a heterogeneous cohort and we ...

  3. Adult outcomes of teen mothers across birth cohorts

    OpenAIRE

    Anne Driscoll

    2014-01-01

    Background: Teen and young adult mothers have lower socioeconomic status than older mothers. Objective: This study analyzes the socioeconomic status (SES) of teen, young adult, and older adult mothers across four five-year birth cohorts from 1956 to 1975 who were teens from 1971 to 1994. Methods: Data were pooled from the 1995, 2002, and 2006-2010 National Survey of Family Growth (NSFG). Mothers were categorized by age at first birth and by their birth cohorts. The SES (education, singl...

  4. Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol.

    Science.gov (United States)

    Heatley, Gerald; Sood, Poornima; Goldstein, Daniel; Uriel, Nir; Cleveland, Joseph; Middlebrook, Don; Mehra, Mandeep R

    2016-04-01

    The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous-flow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transplant (BTT) and destination therapy (DT) are established dichotomous indications for durable left ventricular assist device (LVAD) support, clinical practice has challenged the appropriateness of these designations. The introduction of novel LVAD technology allows for the development of clinical trial designs to keep pace with current practices. The prospective, randomized Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) clinical trial aims to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS (also St. Jude Medical, Inc.). The innovative trial design includes patients enrolled under a single inclusion and exclusion criteria , regardless of the intended use of the device, with outcomes ascertained in the short term (ST, at 6 months) and long term (LT, at 2 years). This adaptive trial design includes a pre-specified safety phase (n = 30) analysis. The ST cohort includes the first 294 patients and the LT cohort includes the first 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD support free of debilitating stroke (modified Rankin score >3), or re-operation to replace the pump. As part of the adaptive design, an analysis by an independent statistician will determine whether sample size adjustment is required at pre-specified times during the study. A further 662

  5. Comparing Three South African Student Cohorts on Their Attitudes to the Rights of Working Women

    Science.gov (United States)

    Patel, Cynthia Joan

    2016-01-01

    This study compares three cohorts (1998-1999, 2005-2006 and 2010) of undergraduate psychology students at a South African university on the level of support for working women (women in paid employment) on various issues considered to be feminist. Cohort 1 (n?=?244), cohort 2 (n?=?311) and cohort 3 (n?=?266) completed an adapted version of a…

  6. 34 CFR 694.3 - What are the requirements for a cohort?

    Science.gov (United States)

    2010-07-01

    ... 34 Education 3 2010-07-01 2010-07-01 false What are the requirements for a cohort? 694.3 Section... PROGRAMS (GEAR UP) § 694.3 What are the requirements for a cohort? (a) In general. Each cohort to be served... promote program effectiveness, a cohort may consist of all of the students in a particular grade level...

  7. Factors associated with inadequate diagnosis of COPD: On-Sint cohort analysis

    Directory of Open Access Journals (Sweden)

    Fernández-Villar A

    2015-05-01

    Full Text Available Alberto Fernández-Villar,1 José Luis López-Campos,2,3 Cristina Represas Represas,1 Lucía Marín Barrera,3 Virginia Leiro Fernández,1 Cecilia López Ramírez,3 Ricard Casamor4 1Department of Pneumology, Complexo Hospitalario de Vigo, Instituto de Investigación Biomédica de Vigo, Vigo, 2Medical-Surgical Unit of Respiratory Diseases, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío/Universidad de Sevilla, Seville, 3Centro de Investigación Biomédica en Red de Respiratorio, Instituto de Salud Carlos III, Madrid, 4Medical Department, Novartis Farmacéutica, Barcelona, Spain Background: The purpose of this study was to evaluate the frequency of inadequate diagnosis and factors predictive of this in patients with chronic obstructive pulmonary disease (COPD participating in the On-Sint study. Methods: The On-Sint cohort was recruited for a multicenter observational study in which 356 physicians (71.6% from primary care included adult patients who had been diagnosed with COPD. Patients’ clinical and functional information since diagnosis and details for the recruiting physicians were collected from patient files and at the inclusion visit. We performed a multivariate analysis to evaluate the influence of these variables on diagnostic inadequacy (absence of postbronchodilator forced expiratory volume in one second/forced vital capacity [FEV1/FVC] <0.70 or, if this value was missing, prebronchodilator FEV1/FVC <0.70. Results: In total, 1,214 patients were included in the study. The patients had a mean age of 66.4±9.7 years and 78.8% were male. In total, 51.3% of patients did not have an obstructive spirometry performed, and 21.4% had a normal or non-obstructive spirometry pattern. Patient-related factors associated with inadequate diagnosis were: years since diagnosis (odds ratio [OR] 1.03, 95% confidence interval [CI] 1.01–1.05, number of exacerbations in the previous year (OR 1.01, 95% CI 1.01–1

  8. Comparative analysis of MR imaging, Ictal SPECT and EEG in temporal lobe epilepsy: a prospective IAEA multi-center study

    Energy Technology Data Exchange (ETDEWEB)

    Zaknun, John J. [University Hospital of Innsbruck, Department of Nuclear Medicine, Innsbruck (Austria); International Atomic Energy Agency (IAEA), Nuclear Medicine Section, Division of Human Health, Vienna (Austria); IAEA, Nuclear Medicine Section, Division of Human Health, Wagramer Strasse 5, P.O. Box 100, Wien (Austria); Bal, Chandrasekhar [All India Institute of Medical Sciences, Department of Nuclear Medicine, New Delhi (India); Maes, Alex [Katholieke Universiteit Leuven, Leuven (Belgium); AZ Groeninge, Department of Nuclear Medicine, Kortrijk (Belgium); Tepmongkol, Supatporn [Chulalongkorn University, Nuclear Medicine Division, Department of Radiology, Bangkok (Thailand); Vazquez, Silvia [Instituto de Investigaciones Neurologicas, FLENI, Department of Radiology, Buenos Aires (Argentina); Dupont, Patrick [Katholieke Universiteit Leuven, Leuven (Belgium); Dondi, Maurizio [Ospedale Maggiore, Department of Nuclear Medicine, Bologna (Italy); International Atomic Energy Agency (IAEA), Nuclear Medicine Section, Division of Human Health, Vienna (Austria)

    2008-01-15

    MR imaging, ictal single-photon emission CT (SPECT) and ictal EEG play important roles in the presurgical localization of epileptic foci. This multi-center study was established to investigate whether the complementary role of perfusion SPECT, MRI and EEG for presurgical localization of temporal lobe epilepsy could be confirmed in a prospective setting involving centers from India, Thailand, Italy and Argentina. We studied 74 patients who underwent interictal and ictal EEG, interictal and ictal SPECT and MRI before surgery of the temporal lobe. In all but three patients, histology was reported. The clinical outcome was assessed using Engel's classification. Sensitivity values of all imaging modalities were calculated, and the add-on value of SPECT was assessed. Outcome (Engel's classification) in 74 patients was class I, 89%; class II, 7%; class III, 3%; and IV, 1%. Regarding the localization of seizure origin, sensitivity was 84% for ictal SPECT, 70% for ictal EEG, 86% for MRI, 55% for interictal SPECT and 40% for interictal EEG. Add-on value of ictal SPECT was shown by its ability to correctly localize 17/22 (77%) of the seizure foci missed by ictal EEG and 8/10 (80%) of the seizure foci not detected by MRI. This prospective multi-center trial, involving centers from different parts of the world, confirms that ictal perfusion SPECT is an effective diagnostic modality for correctly identifying seizure origin in temporal lobe epilepsy, providing complementary information to ictal EEG and MRI. (orig.)

  9. Therapy response evaluation of malignant lymphoma in a multicenter study. Comparison of manual and semiautomatic measurements in CT

    Energy Technology Data Exchange (ETDEWEB)

    Wessling, J.; Schuelke, C. [Muenster Univ. (Germany). Dept. of Clinical Radiology; Koch, R. [Muenster Univ. (Germany). Dept. of Medical Informatics and Biomathematics; and others

    2014-08-15

    Purpose: Comparison of manual one-/bi-dimensional measurements versus semi-automatically derived one-/bi-dimensional and volumetric measurements for therapy response evaluation of malignant lymphoma during CT follow-up examinations in a multicenter setting. Materials and Methods: MSCT data sets of patients with malignant lymphoma were evaluated before (baseline) and after two cycles of chemotherapy (follow-up) at radiological centers of five university hospitals. The long axis diameter (LAD), the short axis diameter (SAD) and the bi-dimensional WHO of 307 target lymph nodes were measured manually and semi-automatically using dedicated software. Lymph node volumetry was performed semi-automatically only. The therapeutic response was evaluated according to lymphoma-adapted RECIST. Results: Based on a single lymph node, semi-automatically derived multidimensional parameters allowed for significantly more accurate therapy response classification than the manual or the semi-automatic unidimensional parameters. Incorrect classifications were reduced by up to 9.6%. Compared to the manual approach, the influence of the study center on correct therapy classification is significantly less relevant when using semi-automatic measurements. Conclusion: Semi-automatic volumetry and bi-dimensional WHO significantly reduce the number of incorrectly classified lymphoma patients by approximately 9.6% in the multicenter setting in comparison to linear parameters. Semi-automatic quantitative software tools may help to significantly reduce wrong classifications that are associated with the manual assessment approach. (orig.)

  10. Therapy response evaluation of malignant lymphoma in a multicenter study. Comparison of manual and semiautomatic measurements in CT

    International Nuclear Information System (INIS)

    Purpose: Comparison of manual one-/bi-dimensional measurements versus semi-automatically derived one-/bi-dimensional and volumetric measurements for therapy response evaluation of malignant lymphoma during CT follow-up examinations in a multicenter setting. Materials and Methods: MSCT data sets of patients with malignant lymphoma were evaluated before (baseline) and after two cycles of chemotherapy (follow-up) at radiological centers of five university hospitals. The long axis diameter (LAD), the short axis diameter (SAD) and the bi-dimensional WHO of 307 target lymph nodes were measured manually and semi-automatically using dedicated software. Lymph node volumetry was performed semi-automatically only. The therapeutic response was evaluated according to lymphoma-adapted RECIST. Results: Based on a single lymph node, semi-automatically derived multidimensional parameters allowed for significantly more accurate therapy response classification than the manual or the semi-automatic unidimensional parameters. Incorrect classifications were reduced by up to 9.6%. Compared to the manual approach, the influence of the study center on correct therapy classification is significantly less relevant when using semi-automatic measurements. Conclusion: Semi-automatic volumetry and bi-dimensional WHO significantly reduce the number of incorrectly classified lymphoma patients by approximately 9.6% in the multicenter setting in comparison to linear parameters. Semi-automatic quantitative software tools may help to significantly reduce wrong classifications that are associated with the manual assessment approach. (orig.)

  11. Comparative analysis of MR imaging, Ictal SPECT and EEG in temporal lobe epilepsy: a prospective IAEA multi-center study

    International Nuclear Information System (INIS)

    MR imaging, ictal single-photon emission CT (SPECT) and ictal EEG play important roles in the presurgical localization of epileptic foci. This multi-center study was established to investigate whether the complementary role of perfusion SPECT, MRI and EEG for presurgical localization of temporal lobe epilepsy could be confirmed in a prospective setting involving centers from India, Thailand, Italy and Argentina. We studied 74 patients who underwent interictal and ictal EEG, interictal and ictal SPECT and MRI before surgery of the temporal lobe. In all but three patients, histology was reported. The clinical outcome was assessed using Engel's classification. Sensitivity values of all imaging modalities were calculated, and the add-on value of SPECT was assessed. Outcome (Engel's classification) in 74 patients was class I, 89%; class II, 7%; class III, 3%; and IV, 1%. Regarding the localization of seizure origin, sensitivity was 84% for ictal SPECT, 70% for ictal EEG, 86% for MRI, 55% for interictal SPECT and 40% for interictal EEG. Add-on value of ictal SPECT was shown by its ability to correctly localize 17/22 (77%) of the seizure foci missed by ictal EEG and 8/10 (80%) of the seizure foci not detected by MRI. This prospective multi-center trial, involving centers from different parts of the world, confirms that ictal perfusion SPECT is an effective diagnostic modality for correctly identifying seizure origin in temporal lobe epilepsy, providing complementary information to ictal EEG and MRI. (orig.)

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

    OpenAIRE

    Tigchelaar, E.F.; Zhernakova, A; Dekens, J.A.M.; Hermes, G.D.A.; Baranska, A.; Mujagic, Z.; M.A. Swertz; Munoz, A.M.; Deelen, P.; Cenit, M. C.; Franke, L; Scholtens, S.; Stolk, R.P.; Wijmenga, C; Feskens, E.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 part...

  13. Opium use and mortality in Golestan Cohort Study: prospective cohort study of 50 000 adults in Iran

    OpenAIRE

    Khademi, Hooman; Malekzadeh, Reza; Pourshams, Akram; Jafari, Elham; Salahi, Rasool; Semnani, Shahryar; Abaie, Behrooz; Islami, Farhad; Nasseri-Moghaddam, Siavosh; Etemadi, Arash; Byrnes, Graham; Abnet, Christian C.; Dawsey, Sanford M.; Day, Nicholas E; Pharoah, Paul D

    2012-01-01

    Objectives To investigate the association between opium use and subsequent risk of death. Design Prospective cohort study. Setting The Golestan Cohort Study in north-eastern Iran collected detailed validated data on opium use and other exposures at baseline. Participants were enrolled between January 2004 and June 2008 and were followed to May 2011, with a follow-up success rate of over 99%. Participants 50 045 participants aged 40-75 at baseline. Main outcomes Mortality, all cause and major ...

  14. Clinical disorders in a post war British cohort reaching retirement: evidence from the First National Birth Cohort Study

    OpenAIRE

    Pierce , MB; Silverwood, RJ; Nitsch, D.; Adams, JE; Stephen, AM; Nip, W; Macfarlane, P; Wong, A.; Richards, M.; Hardy, R; Kuh, D.; on behalf of the NSHD Scientific and Data Collection Teams

    2012-01-01

    Background The medical needs of older people are growing because the proportion of the older population is increasing and disease boundaries are widening. This study describes the distribution and clustering of 15 common clinical disorders requiring medical treatment or supervision in a representative British cohort approaching retirement, and how health tracked across adulthood. Methods and Findings The data come from a cohort of 2661 men and women, 84% of the target sample, fo...

  15. Cohort shifts in the timing of births in Ghana.

    Science.gov (United States)

    Oheneba-sakyi, Y

    1989-01-01

    A comparison of cohorts of ever-married Chanaian women suggests evidence of a fertility transition beginning among younger women and select subgroups. Ghana's crude birth rate declined from a high of 50/1000 population in 1970 to 38.8/1000 in 1985. To ascertain whether marital fertility is now being controlled through conscious attempts to lengthen birth intervals, World Fertility Survey data from 1979-80 on the timing of births among different birth cohorts were analyzed. It was hypothesized that, as a result of the influence of Western values that stress independence from parents and the introduction of compulsory education, cohorts of the mid-1950s and 1960s would be more likely to postpone childbearing, more active in the modern sector of the economy, and more accepting of modern contraceptive usage for birth spacing than women in the 1930-39, 1940-49, and 1950-59 cohorts. For the 1940-49 cohort, it took 10.8 months for 25% to have a birth following 1st marriage, 18.7 months for 50% to have a 1st birth, and 27.4 months for 75% to complete this step. By comparison, these figures for the 1955-64 birth cohort were 9.9, 16.7, and 20.5 months, respectively. The significantly shorter (p 0.01) interval between marriage and 1st birth found among younger women in part reflects rising age at marriage; mean age at 1st marriage was 17.9 years for the 1940 cohort and 21.6 years for the most recent cohort. After the birth of the 1st child, recent cohorts were more likely to wait longer for the 2nd birth. For women born in 1950-64, it took 21.8, 36.7, and 44.6 months for 25%, 50%, and 75%, respectively, to reach parity 2. This pattern of lengthened birth interval beyond the 1st birth was apparent at all parities in the youngest cohort and indicates increasing acceptance of contraception among those who have come of age during a period of rapid social change. PMID:12342944

  16. Gemcitabine and irinotecan as first-line therapy for carcinoma of unknown primary: results of a multicenter phase II trial.

    Directory of Open Access Journals (Sweden)

    Shernan G Holtan

    Full Text Available Metastatic carcinoma of unknown primary (CUP has a very poor prognosis, and no standard first-line therapy currently exists. Here, we report the results of a phase II study utilizing a combination of gemcitabine and irinotecan as first-line therapy. Treatment was with gemcitabine 1000 mg/m(2 and irinotecan 75 mg/m(2 weekly times four on a six week cycle (Cohort I. Due to excessive toxicity, the dose and schedule were modified as follows: gemcitabine 750 mg/m(2 and irinotecan 75 mg/m(2 given weekly times three on a four week cycle (Cohort II. The primary endpoint was the confirmed response rate (CR + PR. Secondary endpoints consisted of adverse events based upon the presence or absence of the UDP glucuronosyltransferase 1 family, polypeptide A1*28 (UGT1A1*28 polymorphism, time to progression, and overall survival. Thirty-one patients were enrolled with a median age of 63 (range: 38-94, and 26 patients were evaluable for efficacy. Significant toxicity was observed in Cohort 1, characterized by 50% (7/14 patients experiencing a grade 4+ adverse event, but not in cohort II. The confirmed response rate including patients from both cohorts was 12% (95% CI: 2-30%, which did not meet the criteria for continued enrollment. Overall median survival was 7.2 months (95% CI: 4.0 to 11.6 for the entire cohort but notably longer in cohort II than in cohort I (9.3 months (95% CI: 4.1 to 12.1 versus 4.0 months (95% CI: 2.2 to 15.6. Gemcitabine and irinotecan is not an active combination when used as first line therapy in patients with metastatic carcinoma of unknown primary. Efforts into developing novel diagnostic and therapeutic approaches remain important for improving the outlook for this heterogeneous group of patients.ClinicalTrials.gov NCT00066781.

  17. Severe Septic Patients with Mitochondrial DNA Haplogroup JT Show Higher Survival Rates: A Prospective, Multicenter, Observational Study

    OpenAIRE

    Lorente, Leonardo; Iceta, Ruth; Martín, María M.; López-Gallardo, Esther; Solé-Violán, Jordi; Blanquer, José; Labarta, Lorenzo; Díaz, César; Borreguero-León, Juan María; Jiménez, Alejandro; Montoya, Julio; Ruiz-Pesini, Eduardo

    2013-01-01

    Objective In a previous cohort study (n=96), we found an association between mitochondrial (mt) DNA haplogroup JT and increased survival of severe septic patients, after controlling for age and serum lactic acid levels. The aim of this research was to increase the predictive accuracy and to control for more confounder variables in a larger cohort (n=196) of severe septic patients, to confirm whether mtDNA haplogroup JT influences short and medium-term survival in these patients. Methods We co...

  18. A Prospective, Multicentered Study to Assess Social Adjustment in Patients With an Intestinal Stoma in Turkey.

    Science.gov (United States)

    Karadağ, Ayişe; Karabulut, Hatice; Baykara, Zehra G; Harputlu, Deniz; Toyluk, Eylem; Ulusoy, Birgül; Karadağ, Sercan; Kahraman, Aysel; Hin, Aysel Ören; Altinsoy, Meral; Akıl, Yasemin; Leventoğlu, Sezai

    2015-10-01

    with planned stoma operations and persons with permanent stomas increased significantly (P less than 0.05) between assessments. Significant increases in OAI-23 scores also were noted among persons who did not receive information before the operation, patients whose stoma site was not marked, and patients who had experienced a complication (P less than 0.05). Postoperatively, it is important to consider sociodemographic and stoma characteristics as well as preoperative variables that may influence adaptation to stoma. Additional larger, multicentered studies with extended patient follow-up are warranted. PMID:26479123

  19. Early loading of plalatal implants (ortho-type II a prospective multicenter randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Gedrange Tomasz

    2007-09-01

    Full Text Available Abstract Background In orthodontic treatment, anchorage control is a fundamental aspect. Usually conventional mechanism for orthodontic anchorage control can be either extraoral or intraoral that is headgear or intermaxillary elastics. Their use are combined with various side effects such as tipping of occlusal plane or undesirable movements of teeth. Especially in cases, where key-teeth are missing, conventional anchorage defined as tooth-borne anchorage will meet limitations. Therefore, the use of endosseous implants for anchorage purposes are increasingly used to achieve positional stability and maximum anchorage. Methods/Design The intended study is designed as a prospective, multicenter randomized controlled trial (RCT, comparing and contrasting the effect of early loading of palatal implant therapy versus implant loading after 12 weeks post implantation using the new ortho-implant type II anchor system device (Orthosystem Straumann, Basel, Switzerland. 124 participants, mainly adult males or females, whose diagnoses require temporary stationary implant-based anchorage treatment will be randomized 1:1 to one of two treatment groups: group 1 will receive a loading of implant standard therapy after a healing period of 12 week (gold standard, whereas group 2 will receive an early loading of orthodontic implants within 1 week after implant insertion. Participants will be at least followed for 12 months after implant placement. The primary endpoint is to investigate the behavior of early loaded palatal implants in order to find out if shorter healing periods might be justified to accelerate active orthodontic treatment. Secondary outcomes will focus e.g. on achievement of orthodontic treatment goals and quantity of direct implant-bone interface of removed bone specimens. As tertiary objective, a histologic and microtomography evaluation of all retrieved implants will be performed to obtain data on the performance of the SLA surface in human bone

  20. The effectiveness of video interaction guidance in parents of premature infants: A multicenter randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Tooten Anneke

    2012-06-01

    Full Text Available Abstract Background Studies have consistently found a high incidence of neonatal medical problems, premature births and low birth weights in abused and neglected children. One of the explanations proposed for the relation between neonatal problems and adverse parenting is a possible delay or disturbance in the bonding process between the parent and infant. This hypothesis suggests that due to neonatal problems, the development of an affectionate bond between the parent and the infant is impeded. The disruption of an optimal parent-infant bond -on its turn- may predispose to distorted parent-infant interactions and thus facilitate abusive or neglectful behaviours. Video Interaction Guidance (VIG is expected to promote the bond between parents and newborns and is expected to diminish non-optimal parenting behaviour. Methods/design This study is a multi-center randomised controlled trial to evaluate the effectiveness of Video Interaction Guidance in parents of premature infants. In this study 210 newborn infants with their parents will be included: n = 70 healthy term infants (>37 weeks GA, n = 70 moderate term infants (32–37 weeks GA which are recruited from maternity wards of 6 general hospitals and n = 70 extremely preterm infants or very low birth weight infants (i.e. full term infants and their parents, receiving care as usual, a control group (i.e. premature infants and their parents, receiving care as usual and an intervention group (i.e. premature infants and their parents, receiving VIG. The data will be collected during the first six months after birth using observations of parent-infant interactions, questionnaires and semi-structured interviews. Primary outcomes are the quality of parental bonding and parent-infant interactive behaviour. Parental secondary outcomes are (posttraumatic stress symptoms, depression, anxiety and feelings of anger and hostility. Infant secondary outcomes are behavioral aspects such as crying

  1. Prognostic power of abnormal cytogenetics for multiple myeloma:a multicenter study in China

    Institute of Scientific and Technical Information of China (English)

    LAI Yue-yun; FU Wei-ling; GUO Hai-ying; HOU Ming; HOU Jian; HU Yu; HU Xiao-tong; HU Xiao-mei; HUANG Li-qiang; JIN Jie; LI Jian-yong; HUANG Xiao-jun; LI Juan; Li Wei; LIANG Ying-min; LIU Ting; LIU Qi-fa; LIU Yan-hui; MAO Ping; OUYANG Jian; QIU Lu-gui; QIU Lin; CAI Zhen; SHAO Chun-kui; SHI Bin; SONG Yong-ping; SUN Zi-min; WANG Qi-shan; WANG Chun; WANG Jian-ming; WANG Yun-shan; WANG Zhao; WU Jian-bo; CAO Xiang-shan; WU Yin-xia; XIA Rui-xiang; XUE Yong-quan; YANG Bao-zhen; YANG Guang; YANG Zheng-lin; YU Li; YUAN Zhong; ZHANG Sheng; ZHANG Yin; CHEN Fang-ping; ZHAO Hong-guo; ZHAO Li; ZHOU Dao-bin; ZOU Shan-hua; ZHU Yun-feng; CHEN Xie-qun; CHEN Bao-an; FANG Mei-yun; FENG Jia-fu

    2012-01-01

    Background Chromosomal abnormalities have been shown to play an important prognostic role in multiple myeloma (MM).tnterphase fluorescence in situ hybridization (i-FISH) has been much more effective to identify cytogenetic aberrations in MM than conventional cytogenetic technique (CC).To clearly determine the cytogenetic features of Chinese MM patients and identify their prognostic implications,we designed a multicenter study based on i-FISH including 672 patients from 52 hospitals in China.Methods All 672 patients were systematically screened for the following genomic aberrations:del(13q).lgHrearrangement,del(p53) and 1q21 amplifications.Results The analysis showed that the chromosomal changes were detected in 22.1% patients by CC and in 82.3%patients by i-FISH.The most common abnormalities by CC were chromosome 1 aberrations (48.4%),-13/13q- (37.6%),hyperdiploidy (36.6%),hypodiploidy (30.1%) and lgH rearrangements (23.7%).The most frequent abnormalities by FISH was del(13q),which was found in 60.4% patients.whereas IgH rearrangement,1q21 amplification and p53 deletions were detected in 57.6%,49.0% and 34.7% cases.respectively.By statistical analysis.-13/13q- by CC was associated with low level of platelet (P=0.015).hyperdiploidy was associated with low level of serum albumin (P=0.028),and lgH rearrangement by FISH was associated with high level of β32 microglobulin (P=0.019).Moreover,1q21 amplification and del(p53) by FlSH conferred a high incidence of progressive disease (PD) after initial therapy.Metaphase detection of lgH rearrangements and chromosome 1 aberrations concurrently was associated with a short progression free survival (PFS)(P=0.036).No significant prognostic implications of other cytogenetic abnormalities were found associated with overall survival and PFS.Conclusions Chinese MM patients had similar cytogenetic abnormalities compared with the previous reported studies.However,the prognostic significance of FISH aberrations

  2. Application of a nanotechnology antimicrobial spray to prevent lower urinary tract infection: a multicenter urology trial

    Science.gov (United States)

    2012-01-01

    Background Catheter-associated urinary tract infection (CAUTI) is a common nosocomial device-associated infection. It is now recognized that the high infection rates were caused by the formation of biofilm on the surface of the catheters that decreases the susceptibility to antibiotics and results in anti-microbial resistance. In this study, we performed an in vitro test to explore the mechanism of biofilm formation and subsequently conducted a multi-center clinical trial to investigate the efficacy of CAUTI prevention with the application of JUC, a nanotechnology antimicrobial spray. Methods Siliconized latex urinary catheters were cut into fragments and sterilized by autoclaving. The sterilized sample fragments were randomly divided into the therapy and control group, whereby they were sprayed with JUC and distilled water respectively and dried before use. The experimental standard strains of Escherichia coli (E. coli) were isolated from the urine samples of patients. At 16 hours and 7 days of incubation, the samples were extracted for confocal laser scanning microscopy. A total of 1,150 patients were accrued in the clinical study. Patients were randomized according to the order of surgical treatment. The odd array of patients was assigned as the therapy group (JUC), and the even array of patients was assigned as the control group (normal saline). Results After 16 hours of culture, bacterial biofilm formed on the surface of sample fragments from the control group. In the therapy group, no bacterial biofilm formation was observed on the sample fragments. No significant increase in bacterial colony count was observed in the therapy group after 7 days of incubation. On the 7th day of catheterization, urine samples were collected for bacterial culture before extubation. Significant difference was observed in the incidence of bacteriuria between the therapy group and control group (4.52% vs. 13.04%, p < 0.001). Conclusions In this study, the effectiveness of JUC in

  3. Pharmacotherapy of elderly patients in everyday anthroposophic medical practice: a prospective, multicenter observational study

    Directory of Open Access Journals (Sweden)

    Bockelbrink Angelina

    2010-07-01

    Full Text Available Abstract Background Pharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care. Methods Twenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. Results In 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female were included. The most frequent diagnoses were hypertension (11.1%, breast cancer (3.5%, and heart failure (3.0%. In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic. The adjusted odds ratio (AOR for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79, treatment by an internist (AOR = 1.49; CI: 1.40-1.58, female patients (AOR = 1.35; CI: 1.27-1.43, cancer (AOR = 4.54; CI: 4.12-4.99, arthropathies (AOR = 1.36; CI: 1.19-1.55, or dorsopathies (AOR = 1.34; CI: 1.16-1.55 and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98. The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39, diabetes mellitus (AOR = 0.17; CI: 0

  4. Clinical and functional outcomes of the PCCP study: a multi-center prospective study in Italy.

    Science.gov (United States)

    Antonini, G; Giancola, R; Berruti, D; Blanchietti, E; Pecchia, P; Francione, V; Greco, P; Russo, T C; Pietrogrande, L

    2013-04-01

    The standard surgical management of hip fractures is associated with tissue trauma and bleeding which are added to the fracture injury. The percutaneous compression plate (PCCP) is a minimally invasive device that has been demonstrated in previous studies to reduce postoperative complications and blood loss. This prospective, multi-center, observational study assessed clinical and functional outcomes with PCCP as treatment for trochanteric fractures. Patients with a stable or unstable proximal femoral fracture of type AO 31.A1 or 31.A2 were enrolled in eight hospitals in Italy. The primary outcome of interest was the recovery of the pre-fracture functional status at 1-year follow-up; secondary outcomes of interest included blood transfusions, surgical time, complications, and mortality. A total of 273 patients were enrolled. The ASA score was 3 or 4 in 72.5 % of patients. The mean surgical time was 44.1 min; the mean post-surgery blood transfusions was 0.9 units. At 1 year, 48 patients (17.6 %) died, 28 (10.2 %) were lost to follow-up, 4 patients (1.5 %) were excluded, hence 193 patients (70.3 %) were available for final evaluation. At the 1-year follow-up visit, 51.9 % of patients recovered or improved their pre-fracture modified Harris Hip Score, 49.1 % of patients improved or maintained their walking abilities, and 66.6 % of patients residing at home pre-surgery maintained their domicile. The overall mortality rate was 17.6 %. Major complications included two fracture collapses, one excessive sliding of the cephalic screw leading to a partial fracture collapse and one back-out of the diaphyseal screw. This study demonstrates that treatment of trochanteric fractures with PCCP gives good outcomes and significant advantages such as low blood loss, short surgical time, low risk of complications, and good functional recovery in the majority of the patients. PMID:23543403

  5. Intraoperative photodynamic therapy of bladder cancer with alasens (results of multicenter trial

    Directory of Open Access Journals (Sweden)

    E. V. Filonenko

    2014-01-01

    Full Text Available The results of multicenter prospective trial for efficacy of combined modality treatment: transurethral resection (TUR + photodynamic therapy (PDT with alasens for bladder cancer are represented in the article. Trials were organized by Research Institute of Organic Intermediates and Dyes and conducted according to clinical protocol approved by Ministry of Health of Russia, at the sites of leading Russian cancer clinical centers. The trial included 45 subjects with verified diagnosis of non-muscle-invasive bladder cancer. Patients underwent TUR of bladder with simultaneous PDT as anti-relapse treatment. Alasens was administered to patients as intravesicular instillation of 3% solution in volume of 50 ml with 1.5–2h exposure (prior to TUR. TUR was performed after instillation. PDT session was conducted immediately after the completion of TUR on a single occasion by means of combined local irradiation on tumor bed with diffuse irradiation on whole urinary bladder mucosa (light dose of local irradiation – 100 J/cm2, diffuse irradiation – 20 J/cm2. Good tolerance of the treatment was noticed, there were no complications. Among 45 patients included in the trial, 35 (78% completed 12 month protocol follow-up without relapse. The recurrence of bladder tumor was registered in 10 (22% cases 6–12 months after TUR+PDT including 3 patients with recurrence 6 months after treatment, 3–9 months and 4–12 months. These patients underwent repeated TUR, whereafter their follow-up in the settings of the clinical trial was disposed. Thus, PDT with alasens after TUR allowed to decrease the recurrence rate of non-muscle-invasive bladder cancer for 1st year after treatment to 22% versus 40–80% for TUR as monotherapy according to literature data. The obtained results were comparable by efficiency with TUR combined with methods of adjuvant treatment for bladder tumors (the recurrence rates for 1-year follow-up after TUR+chemotherapy – 36–44%, after TUR

  6. Profile of Nigerians with diabetes mellitus - Diabcare Nigeria study group (2008: Results of a multicenter study

    Directory of Open Access Journals (Sweden)

    Sunday Chinenye

    2012-01-01

    Full Text Available Background: Diabetes Mellitus is the commonest endocrine-metabolic disorder in Nigeria similar to the experience in other parts of the world. The aim was to assess the clinical and laboratory profile, and evaluate the quality of care of Nigerian diabetics with a view to planning improved diabetes care. Materials and Methods: In a multicenter study across seven tertiary health centers in Nigeria, the clinical and laboratory parameters of diabetic out-patients were evaluated. Clinical parameters studied include type of diabetes, anthropometry, and blood pressure (BP status, chronic complications of diabetes, and treatment types. Laboratory data assessed included fasting plasma glucose (FPG, 2-h post-prandial (2-HrPP glucose, glycated hemoglobin (HbA1c, urinalysis, serum lipids, electrolytes, urea, and creatinine. Results: A total of 531 patients, 209 (39.4% males and 322 (60.6% females enrolled. The mean age of the patients was 57.1 ± 12.3 years with the mean duration of diabetes of 8.8 ± 6.6 years. Majority (95.4% had type 2 diabetes mellitus (DM compared to type 1 DM (4.6%, with P < 0.001. The mean FPG, 2-HrPP glucose, and HbA1c were 8.1 ± 3.9 mmol/L, 10.6 ± 4.6 mmol/L, and 8.3 ± 2.2%, respectively. Only 170 (32.4% and 100 (20.4% patients achieved the ADA and IDF glycemic targets, respectively. Most patients (72.8% did not practice self-monitoring of blood glucose. Hypertension was found in 322 (60.9%, with mean systolic BP 142.0 ± 23.7 mmHg, and mean diastolic BP 80.7 ± 12.7 mmHg. Diabetic complications found were peripheral neuropathy (59.2%, retinopathy (35.5%, cataracts (25.2%, cerebrovascular disease (4.7%, diabetic foot ulcers (16.0%, and nephropathy (3.2%. Conclusion: Most Nigerian diabetics have suboptimal glycemic control, are hypertensives, and have chronic complications of DM. Improved quality of care and treatment to target is recommended to reduce diabetes-related morbidity and mortality.

  7. Contribution of subtraction ictal SPECT coregistered to MRI to epilepsy surgery. A multicenter study

    International Nuclear Information System (INIS)

    A multicenter prospective study was performed to assess the additional value of a subtraction ictal single photon emission computed tomography (SPECT) coregistered to MRI (SISCOM) technique to traditional side-by-side comparison of ictal- and interictal SPECT images in epilepsy surgery. One hundred and twenty-three patients with temporal and extratemporal lobe epilepsy who had undergone epilepsy surgery after evaluation of scalp ictal and interictal electroencephalogram (EEG), MRI, and ictal and interictal SPECT scans were followed up in terms of postsurgical outcome for a period of at least 1 year. Three reviewers localized the epileptogenic focus using ictal and interictal SPECT images first by side-by-side comparison and subsequently by SISCOM. Concordance of the localization of the epileptogenic focus by SPECT diagnosis with the surgical site and inter-observer agreement between reviewers was compared between side-by-side comparison and SISCOM. Logistic regression analysis was performed in predicting the surgical outcome with the dependent variable being the achievement of a good postsurgical outcome and the independent variables using the SISCOM, side-by-side comparison of ictal and interictal SPECT images, MRI, and scalp ictal EEG. The SISCOM presented better concordance in extratemporal lobe epilepsy and less concordance in temporal lobe epilepsy than side-by-side comparison. Inter-observer concordance was higher in SISCOM than in side-by-side comparison. Much higher concordance of the epileptogenic focus by SPECT diagnosis with the surgical site was obtained in patients with good surgical outcome than in those with poor surgical outcome. These differences in concordance between good and poor surgical outcomes were greater in SISCOM than in side-by-side comparison. Logistic regression analysis showed the highest odds ratio of 12.391 (95% confidence interval; 3.319, 46.254) by SISCOM evaluation for concordance of the epileptogenic focus with the surgical site

  8. Multicenter prospective study of magnetic resonance imaging prior to breast-conserving surgery for breast cancer

    Institute of Scientific and Technical Information of China (English)

    Liu Qian; Liu Yinhua; Xu Ling; Duan Xuening; Li Ting; Qin Naishan; Kang Hua

    2014-01-01

    Background This multicenter prospective study aimed to assess the utility of dynamic enhanced magnetic resonance imaging (MRI) prior to breast-conserving surgery for breast cancer.Methods The research subjects were drawn from patients with primary early resectable breast cancer treated in the breast disease centers of six three-level hospitals in Beijing from 1 January 2010 to 31 December 2012.The participants were allocated to a breast-conserving surgery group (breast-conserving group) or a total mastectomy group (total mastectomy group).Enhanced MRI was used to measure breast volume,longest diameter of tumor and tumor volume.The correlations between these measurements and those derived from histopathologic findings were assessed.The relationships between the success rate of breast-conserving surgery and MRI-and pathology-based measurement results were statistically analyzed in the breast-conserving group.Results The study included 461 cases in the total mastectomy group and 195 in the breast-conserving group.Allocation to these groups was based on clinical indications and patient preferences.The cut-off for concurrence between MRI-and pathology-based measurements of the longest diameter of tumor was set at 0.3 cm.In the total mastectomy group,the confidence interval for 95% concurrence of these measurements was 35.41%-44.63%.Correlation coefficients for MRI and histopathology-based measurements of breast volume,tumor volume and tumor volume/breast volume ratio were r=0.861,0.569,and 0.600,respectively (all P <0.001).In the breast-conserving group,with 0.30 cm taken as the cut-off for concurrence,the 95% confidence interval for MRI and pathology-based measurements of the longest diameter of tumor was 29.98%-44.01%.The subjective and objective success rates for breast-conserving surgery were 100% and 88.54%,respectively.Conclusions There were significant correlations between dynamic enhanced MRI-and histopathology-based measurements of the longest

  9. An international multicenter study on HIV-1 drug resistance testing by 454 ultra-deep pyrosequencing.

    Science.gov (United States)

    Simen, Birgitte B; Braverman, Michael S; Abbate, Isabella; Aerssens, Jeroen; Bidet, Yannick; Bouchez, Olivier; Gabriel, Christian; Izopet, Jacques; Kessler, Harald H; Stelzl, Evelyn; Di Giallonardo, Francesca; Schlapbach, Ralph; Radonic, Aleksander; Paredes, Roger; Recordon-Pinson, Patricia; Sakwa, James; St John, Elizabeth P; Schmitz-Agheguian, Gudrun G; Metzner, Karin J; Däumer, Martin P

    2014-08-01

    The detection of mutant spectra within the viral quasispecies is critical for therapeutic management of HIV-1 infections. Routine clinical application of ultrasensitive genotyping requires reproducibility and concordance within and between laboratories. The goal of the study was to evaluate a new protocol on HIV-1 drug resistance testing by 454 ultra-deep pyrosequencing (454-UDS) in an international multicenter study. Sixteen blinded HIV-1 subtype B samples were provided for 454-UDS as both RNA and cDNA with viral titers of 88,600-573,000 HIV-1 RNA copies/ml. Eight overlapping amplicons spanning protease (PR) codons 10-99 and reverse transcriptase (RT) codons 1-251 were generated using molecular barcoded primers. 454-UDS was performed using the 454 Life Sciences/Roche GS FLX platform. PR and RT sequences were analyzed using 454 Life Sciences Amplicon Variant Analyzer (AVA) software. Quantified variation data were analyzed for intra-laboratory reproducibility and inter-laboratory concordance. Routine population sequencing was performed using the ViroSeq HIV-1 genotyping system. Eleven laboratories and the reference laboratory 454 Life Sciences sequenced the HIV-1 sample set. Data presented are derived from seven laboratories and the reference laboratory since severe study protocol execution errors occurred in four laboratories leading to exclusion. The median sequencing depth across all sites was 1364 reads per position (IQR=809-2065). 100% of the ViroSeq-reported mutations were also detected by 454-UDS. Minority HIV-1 drug resistance mutations, defined as HIV-1 drug resistance mutations identified at frequencies of 1-25%, were only detected by 454-UDS. Analysis of 10 preselected majority and minority mutations were consistently found across sites. The analysis of drug-resistance mutations detected between 1 and 10% demonstrated high intra- and inter-laboratory consistency in frequency estimates for both RNA and prepared cDNA samples, indicating robustness of the

  10. Spanish multicenter study of the epidemiology and mechanisms of amoxicillin-clavulanate resistance in Escherichia coli.

    Science.gov (United States)

    Ortega, Adriana; Oteo, Jesús; Aranzamendi-Zaldumbide, Maitane; Bartolomé, Rosa M; Bou, Germán; Cercenado, Emilia; Conejo, M Carmen; González-López, Juan José; Marín, Mercedes; Martínez-Martínez, Luis; Merino, María; Navarro, Ferran; Oliver, Antonio; Pascual, Alvaro; Rivera, Alba; Rodríguez-Baño, Jesús; Weber, Irene; Aracil, Belén; Campos, José

    2012-07-01

    We conducted a prospective multicenter study in Spain to characterize the mechanisms of resistance to amoxicillin-clavulanate (AMC) in Escherichia coli. Up to 44 AMC-resistant E. coli isolates (MIC ≥ 32/16 μg/ml) were collected at each of the seven participant hospitals. Resistance mechanisms were characterized by PCR and sequencing. Molecular epidemiology was studied by pulsed-field gel electrophoresis (PFGE) and by multilocus sequence typing. Overall AMC resistance was 9.3%. The resistance mechanisms detected in the 257 AMC-resistant isolates were OXA-1 production (26.1%), hyperproduction of penicillinase (22.6%), production of plasmidic AmpC (19.5%), hyperproduction of chromosomic AmpC (18.3%), and production of inhibitor-resistant TEM (IRT) (17.5%). The IRTs identified were TEM-40 (33.3%), TEM-30 (28.9%), TEM-33 (11.1%), TEM-32 (4.4%), TEM-34 (4.4%), TEM-35 (2.2%), TEM-54 (2.2%), TEM-76 (2.2%), TEM-79 (2.2%), and the new TEM-185 (8.8%). By PFGE, a high degree of genetic diversity was observed although two well-defined clusters were detected in the OXA-1-producing isolates: the C1 cluster consisting of 19 phylogroup A/sequence type 88 [ST88] isolates and the C2 cluster consisting of 19 phylogroup B2/ST131 isolates (16 of them producing CTX-M-15). Each of the clusters was detected in six different hospitals. In total, 21.8% of the isolates were serotype O25b/phylogroup B2 (O25b/B2). AMC resistance in E. coli is widespread in Spain at the hospital and community levels. A high prevalence of OXA-1 was found. Although resistant isolates were genetically diverse, clonality was linked to OXA-1-producing isolates of the STs 88 and 131. Dissemination of IRTs was frequent, and the epidemic O25b/B2/ST131 clone carried many different mechanisms of AMC resistance. PMID:22491692

  11. Radiotherapy in stage IIA and IIB testicular seminoma with reduced portals: a prospective multicenter study

    International Nuclear Information System (INIS)

    Purpose: A prospective multicenter study was carried out to estimate the treatment outcome of radiotherapy in Stage II seminoma after the application of modern staging and radiotherapy techniques. The lower margin of the iliac field was positioned on the upper rim of the acetabulum to reduce the amount of scattered irradiation to the remaining testicle. Methods and Materials: The study was carried out in 25 centers in Germany. Patients with pure seminoma, negative AFP-values, and retroperitoneal lymph node metastases of less than 5 cm in diameter were entered into the study. All patients received a ventrodorsal opposed field irradiation of the para-aortic and the ipsilateral iliac lymph nodes. The fields extended from the top of the 11th thoracic vertebra to the top of the acetabulum. Patients in Stage IIA (lymph nodes <2 cm) received 30 Gy, and patients with Stage IIB (lymph nodes between 2 and 5 cm) 36 Gy total dose. Results: 39 patients in Stage IIA and 19 patients in Stage IIB were evaluated. After a median observation time of 37 months all patients are alive and disease free. Recurrence free survival in stage IIA was 100%. Two patients in Stage IIB experienced a recurrence 10 and 17 months after the end of radiotherapy. The actuarial recurrence free survival estimate in Stage IIB was 94.1% for 1 year and 87.4% for 2 years. One recurrence in Stage IIB occurred in the mediastinum, one in the mediastinum, and one the lung. Both patients could be salvaged by chemotherapy. There were no pelvic recurrences. The treatment was well tolerated, with nausea being the most common side effect (56.9% Grade 1, 15.5% Grade 2, and 8.6% Grade 3). Diarrhea occurred in 15.5% (Grade 1), 15.5% (Grade 2), and 5.2% (Grade 3) of the patients. Conclusions: The outcome of para-aortic and ipsilateral iliac irration in Stage IIA/B testicular seminoma is excellent with the currently available staging methods and treatment facilities. The treatment is well tolerated. The lower margin of the

  12. Analysis of β-Lactamase Resistance Determinants in Enterobacteriaceae from Chicago Children: a Multicenter Survey.

    Science.gov (United States)

    Logan, Latania K; Hujer, Andrea M; Marshall, Steven H; Domitrovic, T Nicholas; Rudin, Susan D; Zheng, Xiaotian; Qureshi, Nadia K; Hayden, Mary K; Scaggs, Felicia A; Karadkhele, Anand; Bonomo, Robert A

    2016-06-01

    Multidrug-resistant (MDR) Enterobacteriaceae infections are increasing in U.S. children; however, there is a paucity of multicentered analyses of antibiotic resistance genes responsible for MDR phenotypes among pediatric Enterobacteriaceae isolates. In this study, 225 isolates phenotypically identified as extended-spectrum β-lactamase (ESBL) or carbapenemase producers, recovered from children ages 0 to 18 years hospitalized between January 2011 and April 2015 at three Chicago area hospitals, were analyzed. We used DNA microarray platforms to detect ESBL, plasmid-mediated AmpC (pAmpC), and carbapenemase type β-lactamase (bla) genes. Repetitive-sequence-based PCR and multilocus sequence typing (MLST) were performed to assess isolate similarity. Plasmid replicon typing was conducted to classify plasmids. The median patient age was 4.2 years, 56% were female, and 44% presented in the outpatient setting. The majority (60.9%) of isolates were Escherichia coli and from urinary sources (69.8%). Of 225 isolates exhibiting ESBL- or carbapenemase-producing phenotypes, 90.7% contained a bla gene. The most common genotype was the blaCTX-M-1 group (49.8%); 1.8% were carbapenem-resistant Enterobacteriaceae (three blaKPC and one blaIMP). Overall, pAmpC (blaACT/MIR and blaCMY) were present in 14.2%. The predominant E. coli phylogenetic group was the virulent B2 group (67.6%) associated with ST43/ST131 (Pasteur/Achtman MLST scheme) containing the blaCTX-M-1 group (84%), and plasmid replicon types FIA, FII, and FIB. K. pneumoniae harboring blaKPC were non-ST258 with replicon types I1 and A/C. Enterobacter spp. carrying blaACT/MIR contained plasmid replicon FIIA. We found that β-lactam resistance in children is diverse and that certain resistance mechanisms differ from known circulating genotypes in adults in an endemic area. The potential impact of complex molecular types and the silent dissemination of MDR Enterobacteriaceae in a vulnerable population needs to be studied further

  13. Brazilian multicenter study on prevalence of preterm birth and associated factors

    Directory of Open Access Journals (Sweden)

    Guinsburg Ruth

    2010-05-01

    Full Text Available Abstract Background The occurrence of preterm birth remains a complex public health condition. It is considered the main cause of neonatal morbidity and mortality, resulting in a high likelihood of sequelae in surviving children. With variable incidence in several countries, it has grown markedly in the last decades. In Brazil, however, there are still difficulties to estimate its real occurrence. Therefore, it is essential to establish the prevalence and causes of this condition in order to propose prevention actions. This study intend to collect information from hospitals nationwide on the prevalence of preterm births, their associated socioeconomic and environmental factors, diagnostic and treatment methods resulting from causes such as spontaneous preterm labor, prelabor rupture of membranes, and therapeutic preterm birth, as well as neonatal results. Methods/Design This proposal is a multicenter cross-sectional study plus a nested case-control study, to be implemented in 27 reference obstetric centers in several regions of Brazil (North: 1; Northeast: 10; Central-west: 1; Southeast: 13; South: 2. For the cross sectional component, the participating centers should perform, during a period of six months, a prospective surveillance of all patients hospitalized to give birth, in order to identify preterm birth cases and their main causes. In the first three months of the study, an analysis of the factors associated with preterm birth will also be carried out, comparing women who have preterm birth with those who deliver at term. For the prevalence study, 37,000 births will be evaluated (at term and preterm, corresponding to approximately half the deliveries of all participating centers in 12 months. For the case-control study component, the estimated sample size is 1,055 women in each group (cases and controls. The total number of preterm births estimated to be followed in both components of the study is around 3,600. Data will be collected

  14. The effectiveness of video interaction guidance in parents of premature infants: A multicenter randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Studies have consistently found a high incidence of neonatal medical problems, premature births and low birth weights in abused and neglected children. One of the explanations proposed for the relation between neonatal problems and adverse parenting is a possible delay or disturbance in the bonding process between the parent and infant. This hypothesis suggests that due to neonatal problems, the development of an affectionate bond between the parent and the infant is impeded. The disruption of an optimal parent-infant bond -on its turn- may predispose to distorted parent-infant interactions and thus facilitate abusive or neglectful behaviours. Video Interaction Guidance (VIG) is expected to promote the bond between parents and newborns and is expected to diminish non-optimal parenting behaviour. Methods/design This study is a multi-center randomised controlled trial to evaluate the effectiveness of Video Interaction Guidance in parents of premature infants. In this study 210 newborn infants with their parents will be included: n = 70 healthy term infants (>37 weeks GA), n = 70 moderate term infants (32–37 weeks GA) which are recruited from maternity wards of 6 general hospitals and n = 70 extremely preterm infants or very low birth weight infants (<32 weeks GA) recruited by the NICU of 2 specialized hospitals. The participating families will be divided into 3 groups: a reference group (i.e. full term infants and their parents, receiving care as usual), a control group (i.e. premature infants and their parents, receiving care as usual) and an intervention group (i.e. premature infants and their parents, receiving VIG). The data will be collected during the first six months after birth using observations of parent-infant interactions, questionnaires and semi-structured interviews. Primary outcomes are the quality of parental bonding and parent-infant interactive behaviour. Parental secondary outcomes are (posttraumatic) stress symptoms

  15. Diagnosis of tetanus immunization status: multicenter assessment of a rapid biological test.

    Science.gov (United States)

    Colombet, Isabelle; Saguez, Colette; Sanson-Le Pors, Marie-José; Coudert, Benoît; Chatellier, Gilles; Espinoza, Pierre

    2005-09-01

    Diagnosis of tetanus immunization status by medical interview of patients with wounds is poor. Many protected patients receive unnecessary vaccine or immunoglobulin, and unprotected patients may receive nothing. The aim of this study is to evaluate the feasibility and accuracy of the Tetanos Quick Stick (TQS) rapid finger prick stick test in the emergency department for determining immunization status. We designed a prospective multicenter study for blinded comparison of TQS with an enzyme-linked immunosorbent assay (ELISA). Adults referred for open wounds in 37 French hospital emergency departments had the TQS after receiving standard care (emergency-TQS). TQS was also performed in the hospital laboratory on total blood (blood/lab-TQS) and serum (serum/lab-TQS). ELISA was performed with the same blood sample at a central laboratory. We assessed concordance between emergency-TQS and blood/lab-TQS by the kappa test and the diagnostic accuracy (likelihood ratios) of medical interview, emergency-TQS, and lab-TQS. ELISA was positive in 94.6% of the 988 patients included. Concordance between blood/emergency-TQS and blood/lab-TQS results was moderate (kappa=0.6), with a high proportion of inconclusive blood/emergency-TQS tests (9.8%). Likelihood ratios for immunization were 3.0 (95% confidence interval [CI], 1.8 to 5.1), 36.6 (95% CI, 5.3 to 255.3), 89.1 (95% CI, 5.6 to 1,405.0), and 92.7 (95% CI, 5.9 to 1,462.0) for medical interview, blood/emergency-TQS, blood/lab-TQS, and serum/lab-TQS, respectively. The sensitivity of the blood/emergency-TQS was 76.7%, and the specificity was 98% by reference to the ELISA. TQS use in the emergency room could make tetanus prevention more accurate if its technical feasibility were improved, and our assessment will be supplemented by a cost effectiveness study. PMID:16148171

  16. The costs in provision of haemodialysis in a developing country: A multi-centered study

    Directory of Open Access Journals (Sweden)

    Wijesinghe Aruna

    2011-09-01

    % reduction. Conclusions This multi-centered study demonstrated that the costs of haemodialysis in a developing country remained significantly lower compared to developed countries. However, it still places a significant burden on the health care sector, whilst possibility of further cost reduction exists.

  17. A 1-year multicenter randomized double-blind comparison of repaglinide and glyburide for the treatment of type 2 diabetes. Dutch and German Repaglinide Study Group

    NARCIS (Netherlands)

    Wolffenbuttel, B H; Landgraf, R

    1999-01-01

    OBJECTIVE: Repaglinide is a newly developed oral blood glucose-lowering agent that exerts its effect by stimulating insulin secretion. This multicenter study was designed to compare the efficacy and safety of this drug with glyburide in a 1-year randomized double-blind study of outpatients with type

  18. Use of the University of California Los Angeles integrated staging system to predict survival in renal cell carcinoma: an international multicenter study.

    NARCIS (Netherlands)

    Patard, J.J.; Kim, H.L.; Lam, J.; Dorey, F.J.; Pantuck, A.J.; Zisman, A.; Ficarra, V.; Han, K.R.; Cindolo, L.; Taille, A. De La; Tostain, J.; Artibani, W.; Dinney, C.P.; Wood, C.G.; Swanson, D.A.; Abbou, C.C.; Lobel, B.; Mulders, P.F.A.; Chopin, D.K.; Figlin, R.A.; Belldegrun, A.S.

    2004-01-01

    PURPOSE: To evaluate ability of the University of California Los Angeles Integrated Staging System (UISS) to stratify patients with localized and metastatic renal cell carcinoma (RCC) into risk groups in an international multicenter study. PATIENTS AND METHODS: 4,202 patients from eight internationa

  19. OPTIMIZATION OF SKIN TESTING .2. EVALUATION OF CONCENTRATION AND CUTOFF VALUES, AS COMPARED WITH RAST AND CLINICAL HISTORY, IN A MULTICENTER STUDY

    NARCIS (Netherlands)

    NIEMEIJER, NR; FLUKS, AF; DEMONCHY, JGR

    1993-01-01

    In this multicenter study we evaluated the results of a previous study (part I) in a relatively large Dutch patient population, using the two previously tested allergens (house-dust mite and grass pollen) and two other standardized allergens (tree pollen and cat dander). The obtained skin test resul

  20. No important influence of limited steroid exposure on bone mass during the first year after renal transplantation: a prospective, randomized, multicenter study.

    NARCIS (Netherlands)

    Meulen, C.G. ter; Riemsdijk, I.C. van; Hene, R.J.; Christiaans, M.H.; Borm, G.F.; Corstens, F.H.M.; Gelder, T. van; Hilbrands, L.B.; Weimar, W.; Hoitsma, A.J.

    2004-01-01

    BACKGROUND: Steroid-related bone loss is a recognized complication after renal transplantation. In a prospective, randomized, multicenter study we compared the influence of a steroid-free immunosuppressive regimen with a regimen with limited steroid exposure on the changes in bone mass after renal t