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Sample records for non-randomized prospective phase

  1. A prospective, non-randomized phase II trial of Trastuzumab and Capecitabine in patients with HER2 expressing metastasized pancreatic cancer

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    Endlicher Esther

    2009-01-01

    Full Text Available Abstract Background Pancreatic cancer is the fourth most common cause of cancer related death in Western countries. Advantages in surgical techniques, radiation and chemotherapy had almost no impact on the long term survival of affected patients. Therefore, the need for better treatment strategies is urgent. HER2, a receptor tyrosine kinase of the EGFR family, involved in signal transduction pathways leading to cell growth and differentiation is overexpressed in a number of cancers, including breast and pancreatic cancer. While in breast cancer HER2 has already been successfully used as a treatment target, there are only limited data evaluating the effects of inhibiting HER2 tyrosine kinases in patients with pancreatic cancer. Methods Here we report the design of a prospective, non-randomized multi-centered Phase II clinical study evaluating the effects of the Fluoropyrimidine-carbamate Capecitabine (Xeloda ® and the monoclonal anti-HER2 antibody Trastuzumab (Herceptin® in patients with non-resectable, HER2 overexpressing pancreatic cancer. Patients eligible for the study will receive Trastuzumab infusions on day 1, 8 and 15 concomitant to the oral intake of Capecitabine from day 1 to day 14 of each three week cylce. Cycles will be repeated until tumor progression. A total of 37 patients will be enrolled with an interim analysis after 23 patients. Discussion Primary end point of the study is to determine the progression free survival after 12 weeks of bimodal treatment with the chemotherapeutic agent Capecitabine and the anti-HER2 antibody Trastuzumab. Secondary end points include patient's survival, toxicity analysis, quality of life, the correlation of HER2 overexpression and clinical response to Trastuzumab treatment and, finally, the correlation of CA19-9 plasma levels and progression free intervals.

  2. Stereotactic body radiotherapy for medically inoperable patients with stage I non-small cell lung cancer - A first report of toxicity related to COPD/CVD in a non-randomized prospective phase II study

    International Nuclear Information System (INIS)

    Baumann, Pia; Nyman, Jan; Hoyer, Morten; Gagliardi, Giovanna; Lax, Ingmar; Wennberg, Berit; Drugge, Ninni; Ekberg, Lars; Friesland, Signe; Johansson, Karl-Axel; Lund, Jo-Asmund; Morhed, Elisabeth; Nilsson, Kristina; Levin, Nina; Paludan, Merete; Sederholm, Christer; Traberg, Anders; Wittgren, Lena; Lewensohn, Rolf

    2008-01-01

    Background and Aims: In a retrospective study using stereotactic body radiotherapy (SBRT) in medically inoperable patients with stage I NSCLC we previously reported a local control rate of 88% utilizing a median dose of 15 Gy x 3. This report records the toxicity encountered in a prospective phase II trial, and its relation to coexisting chronic obstructive pulmonary disease (COPD) and cardio vascular disease (CVD). Material and methods: Sixty patients were entered in the study between August 2003 and September 2005. Fifty-seven patients (T1 65%, T2 35%) with a median age of 75 years (59-87 years) were evaluable. The baseline mean FEV1% was 64% and median Karnofsky index was 80. A total dose of 45 Gy was delivered in three fractions at the 67% isodose of the PTV. Clinical, pulmonary and radiological evaluations were made at 6 weeks, 3, 6, 9, 12, 18, and 36 months post-SBRT. Toxicity was graded according to CTC v2.0 and performance status was graded according to the Karnofsky scale. Results: At a median follow-up of 23 months, 2 patients had relapsed locally. No grade 4 or 5 toxicity was reported. Grade 3 toxicity was seen in 12 patients (21%). There was no significant decline of FEV1% during follow-up. Low grade pneumonitis developed to the same extent in the CVD 3/17 (18%) and COPD 7/40 (18%) groups. The incidence of fibrosis was 9/17 (53%) and pleural effusions was 8/17 (47%) in the CVD group compared with 13/40 (33%) and 5/40 (13%) in the COPD group. Conclusion: SBRT for stage I NSCLC patients who are medically inoperable because of COPD and CVD results in a favourable local control rate with a low incidence of grade 3 and no grade 4 or 5 toxicity

  3. Multidisciplinary intervention reducing readmissions in medical inpatients: a prospective, non-randomized study

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    Torisson G

    2013-09-01

    Full Text Available Gustav Torisson,1 Lennart Minthon,1 Lars Stavenow,2 Elisabet Londos1 1Clinical Memory Research Unit, Department of Clinical Sciences, Lund University, 2Department of Internal Medicine, Skåne University Hospital, Malmö, Sweden Background: The purpose of this study was to examine whether a multidisciplinary intervention targeting drug-related problems, cognitive impairment, and discharge miscommunication could reduce readmissions in a general hospital population. Methods: This prospective, non-randomized intervention study was carried out at the department of general internal medicine at a tertiary university hospital. Two hundred medical inpatients living in the community and aged over 60 years were included. Ninety-nine patients received interventions and 101 received standard care. Control/intervention allocation was determined by geographic selection. Interventions consisted of a comprehensive medication review, improved discharge planning, post-discharge telephone follow-up, and liaison with the patient's general practitioner. The main outcome measures recorded were readmissions and hospital nights 12 months after discharge. Separate analyses were made for 12-month survivors and from an intention-to-treat perspective. Comparative analyses were made between groups as well as within groups over time. Results: After 12 months, survivors in the control group had 125 readmissions in total, compared with 58 in the intervention group (Mann–Whitney U test, P = 0.02. For hospital nights, the numbers were 1,228 and 492, respectively (P = 0.009. Yearly admissions had increased from the previous year in the control group from 77 to 125 (Wilcoxon signed-rank test, P = 0.002 and decreased from 75 to 58 in the intervention group (P = 0.25. From the intention-to-treat perspective, the same general pattern was observed but was not significant (1,827 versus 1,008 hospital nights, Mann–Whitney test, P = 0.054. Conclusion: A multidisciplinary approach

  4. Non-randomized controlled prospective study on perioperative levels of stress and dysautonomia during dental implant surgery.

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    Morino, Miyuki; Masaki, Chihiro; Seo, Yoshinori; Mukai, Chisato; Mukaibo, Taro; Kondo, Yusuke; Shiiba, Shunji; Nakamoto, Tetsuji; Hosokawa, Ryuji

    2014-07-01

    The purpose of this study was to compare pre- and postoperative autonomic activities and changes in salivary stress biomarkers between patients who received only local anesthesia and those who received local anesthesia together with intravenous sedation in dental implant surgery. A total of 21 patients were enrolled in this non-randomized controlled prospective study; 7 subjects underwent implant surgery under local anesthesia with intravenous sedation and 14 subjects underwent surgery under only local anesthesia. Stress was evaluated by measuring salivary levels of chromogranin A (CgA) and a spectral analysis of heart rate variability (HRV) at baseline (on a day other than the day of surgery), 1h preoperatively, and 1h postoperatively. HRV analysis yields low- (LF) and high-frequency (HF) components, the LF/HF ratio, and the component coefficient of variance (CCV[HF]), which provide indices of sympathetic and parasympathetic regulatory activity. CgA levels were significantly higher (p<0.05) at baseline in patients who received sedation than those who did not, but CgA levels did not differ prior to surgery. Also, the values of most parameters, including LF, HF, LF/HF (L/H), and CCV(HF), did not significantly differ between groups or among the three time points. Only ΔL/H and ΔCCV(HF) were significantly lower (p<0.05) at 1h preoperatively in patients who received sedation than those who received only local anesthesia. CgA levels were high in both groups immediately before surgery, and thus CgA values immediately before surgery may not be a reliable indicator of the need for intravenous sedation. Also, spectral analysis of HRV, especially ΔL/H and ΔCCV(HF), could be useful for assessing tension and anxiety. Copyright © 2014. Published by Elsevier Ltd.

  5. Maternal plasma viral load and neutralizing/enhancing antibodies in vertical transmission of HIV: A non-randomized prospective study

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    Weiss Heidi

    2005-02-01

    Full Text Available Abstract Background We examined the association and interaction between maternal viral load and antibodies in vertical transmission of HIV in a non-randomized prospective study of 43 HIV-1 infected pregnant women who attended the San Juan City Hospital, Puerto Rico, and their 45 newborn infants. The women and infants received antiretroviral therapy. Methods A nested PCR assay of the HIV-1 envelope V3 region and infant PBMC culture were performed to determine HIV status of the infants. Maternal and infant plasma were tested for HIV neutralization or enhancement in monocyte-derived macrophages. Results Twelve (26.7% infants were positive by the HIV V3 PCR assay and 3 of the 12 were also positive by culture. There was a trend of agreement between high maternal viral load and HIV transmission by multivariate analysis (OR = 2.5, CI = 0.92, p = 0.0681. Both maternal and infant plasma significantly (p = 0.001 for both reduced HIV replication at 10-1 dilution compared with HIV negative plasma. Infant plasma neutralized HIV (p = 0.001 at 10-2 dilution but maternal plasma lost neutralizing effect at this dilution. At 10-3 dilution both maternal and infant plasma increased virus replication above that obtained with HIV negative plasma but only the increase by maternal plasma was statistically significant (p = 0.005. There were good agreements in enhancing activity in plasma between mother-infant pairs, but there was no significant association between HIV enhancement by maternal plasma and vertical transmission. Conclusion Although not statistically significant, the trend of association between maternal viral load and maternal-infant transmission of HIV supports the finding that viral load is a predictor of maternal-infant transmission. Both maternal and infant plasma neutralized HIV at low dilution and enhanced virus replication at high dilution. The antiretroviral treatments that the women received and the small sample size may have contributed to the

  6. Natalizumab stabilizes physical, cognitive, MRI, and OCT markers of disease activity: A prospective, non-randomized pilot study.

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    Garrick D Talmage

    Full Text Available Natalizumab is an effective therapy for multiple sclerosis (MS. Its effectiveness has been demonstrated in several clinical and imaging studies. The objective of this study was to further demonstrate the efficacy of natalizumab using a comprehensive battery of clinical and imaging markers in the same cohort of patients followed longitudinally, hence capturing the multi-faceted nature of the MS disease process. A prospective, open-label, pilot study of 20 MS patients treated with natalizumab was conducted. High resolution MRI, Symbol-Digit Modalities Test (SDMT, and Optical Coherence Tomography (OCT scans were obtained at baseline, 48, and 96 weeks. 15 patients completed the study. Natalizumab treatment decreased Expanded Disability Status Scale score (EDSS and no change in SDMT, Brain Parenchymal Fraction (BPF, or any of the OCT markers of retinal degeneration was observed. Thalamic and whole brain volume as assessed by Percentage Brain Volume Change (PBVC showed continuous deterioration. Higher baseline T2 lesion load correlated with increased rate of PBVC at 96-weeks (r = 0.566, R2 = 0.320, p = 0.035 and thalamic volume loss (r = -0.586, R2 = 0.344, p = 0.027. Most patients, 93%, achieved no evidence of disease activity (NEDA at 2 years, likely due to early disease duration and lower initial baseline lesion load. This study further demonstrates stabilization of clinical and imaging markers of disease activity during natalizumab treatment.

  7. Laparoscopic Complete Mesocolic Excision versus Open Complete Mesocolic Excision for Transverse Colon Cancer: Long-Term Survival Results of a Prospective Single Centre Non-Randomized Study.

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    Storli, Kristian Eeg; Eide, Geir Egil

    2016-01-01

    Laparoscopic complete mesocolic excision (CME) used in the treatment of transverse colon cancer has been questioned on the basis of the technical challenges. The aim of this study was to evaluate the medium- and long-term clinical and survival outcomes after laparoscopic and open CME for transverse colon cancer and to compare the 2 approaches. This study was a retrospective non-randomized study of patients with prospectively registered data on open and laparoscopic CME for transverse colon cancer tumour-node-metastasis stages I-III operated on between 2007 and 2014. This was a single-centre study in a community teaching hospital. A total of 56 patients with transverse colon cancer were included, excluding those with tumours in the colonic flexures. The outcome aims were 4-year time to recurrence (TTR) and cancer-specific survival (CSS). Morbidity was also measured. The 4-year TTR was 93.9% in the laparoscopic group and 91.3% in the open group (p = 0.71). The 4-year CSS was 97.0% in the laparoscopic group and 91.3% in the open group (p = 0.42). This was a prospective single-institution study with a small sample size. Results of the study suggest that the laparoscopic CME approach might be the preferred approach for transverse colon cancer, especially regarding its benefits in terms of short-term morbidity, length of stay and oncological outcome. © 2016 S. Karger AG, Basel.

  8. Two-stage revision surgery with preformed spacers and cementless implants for septic hip arthritis: a prospective, non-randomized cohort study

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    Logoluso Nicola

    2011-05-01

    Full Text Available Abstract Background Outcome data on two-stage revision surgery for deep infection after septic hip arthritis are limited and inconsistent. This study presents the medium-term results of a new, standardized two-stage arthroplasty with preformed hip spacers and cementless implants in a consecutive series of adult patients with septic arthritis of the hip treated according to a same protocol. Methods Nineteen patients (20 hips were enrolled in this prospective, non-randomized cohort study between 2000 and 2008. The first stage comprised femoral head resection, debridement, and insertion of a preformed, commercially available, antibiotic-loaded cement hip spacer. After eradication of infection, a cementless total hip arthroplasty was implanted in the second stage. Patients were assessed for infection recurrence, pain (visual analog scale [VAS] and hip joint function (Harris Hip score. Results The mean time between first diagnosis of infection and revision surgery was 5.8 ± 9.0 months; the average duration of follow up was 56.6 (range, 24 - 104 months; all 20 hips were successfully converted to prosthesis an average 22 ± 5.1 weeks after spacer implantation. Reinfection after total hip joint replacement occurred in 1 patient. The mean VAS pain score improved from 48 (range, 35 - 84 pre-operatively to 18 (range, 0 - 38 prior to spacer removal and to 8 (range, 0 - 15 at the last follow-up assessment after prosthesis implantation. The average Harris Hip score improved from 27.5 before surgery to 61.8 between the two stages to 92.3 at the final follow-up assessment. Conclusions Satisfactory outcomes can be obtained with two-stage revision hip arthroplasty using preformed spacers and cementless implants for prosthetic hip joint infections of various etiologies.

  9. The treatment of snoring by radiofrequency-assisted uvulopalatoplasty and results after one-session protocol: a prospective, longitudinal, non-randomized study.

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    Chiesa Estomba, Carlos Miguel; Rivera Schmitz, Teresa; Ossa Echeverri, Carla Cristina; Betances Reinoso, Frank Alberto; Fariña Conde, José; Alonso Parraga, Dionisio

    2015-10-01

    Snoring is usually caused by the vibration of walls of the soft palate at the pharyngeal level. Its worldwide prevalence is estimated to range between 2 and 85% depending on age, gender or population group. The aim of this study is to determine the degree of improvement that can be subjectively evident in patients treated by snoring with radiofrequency-assisted uvulopalatoplasty based on a one-session protocol. This is a prospective, longitudinal, non-randomized study. Patients of both sexes, aged 18 years, who attended to the ENT consultation in a tertiary hospital with snoring during the period of July 2012-July 2013 were included. Age, body mass index, Epworth sleepiness scale were calculated. The volume of snoring of each subject was assessed using a visual analog scale. A total of 27 patients were included in the study; the average age of the sample was 49 years (±8.7; min 36/max 74); of these 22 (81.5%) were male and 5 (18.5%) females. The average BMI was 27.07 ± 2.5 (min 23.15/max 29.39) before the test and after 1 year was 26.75 ± 2.32 (min 23.11/max 29.56) with no statistically significant differences in BMI before and after surgery (p = 0.407). Preoperative snoring intensity was 8.10 ± 0.93 according to VAS. We found a statistically significant difference in the post-operative intensity at 3 months of 3.93 ± 0.88 (p ≤ 0.05) at 6 months of 4.41 ± 1.08 (p ≤ 0.05), and after 1 year 4.90 ± 0.77 (p ≤ 0.05). The average rate of ESS was significantly higher preoperatively than post-operative, being 8.76 ± 3.1 preoperative and 6.93 ± 1.68 post-operative (p ≤ 0.05). We conclude that the use of radiofrequency in simple snorers with an apnea/hypopnea index snoring is the soft palate, can be treated by one-session protocol, being possible to obtain an improvement of snoring up to 70% of cases by a short follow-up period.

  10. Validation of the k-filtering technique for a signal composed of random-phase plane waves and non-random coherent structures

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    O. W. Roberts

    2014-12-01

    Full Text Available Recent observations of astrophysical magnetic fields have shown the presence of fluctuations being wave-like (propagating in the plasma frame and those described as being structure-like (advected by the plasma bulk velocity. Typically with single-spacecraft missions it is impossible to differentiate between these two fluctuations, due to the inherent spatio-temporal ambiguity associated with a single point measurement. However missions such as Cluster which contain multiple spacecraft have allowed for temporal and spatial changes to be resolved, using techniques such as k filtering. While this technique does not assume Taylor's hypothesis it requires both weak stationarity of the time series and that the fluctuations can be described by a superposition of plane waves with random phases. In this paper we test whether the method can cope with a synthetic signal which is composed of a combination of non-random-phase coherent structures with a mean radius d and a mean separation λ, as well as plane waves with random phase.

  11. Is the alpha-beta ratio of prostate cancer really low? A prospective, non-randomized trial comparing standard and hyperfractionated conformal radiation therapy

    International Nuclear Information System (INIS)

    Valdagni, Riccardo; Italia, Corrado; Montanaro, Paolo; Lanceni, Angelo; Lattuada, Paola; Magnani, Tiziana; Fiorino, Claudio; Nahum, Alan

    2005-01-01

    Background and purpose: The objectives of the current study were to compare genito-urinary (GU) and gastro-intestinal (GI) toxicities as well as biochemical control (bRFS) in prostate cancer, utilizing conventional (2.0 Gy daily) (STD) or hyperfractionated (HFX) conformal irradiation (CRT). HFX (1.2 Gy BID) was chosen as a radiobiological method to try to reduce long term sequelae without compromising local control. Patients and methods: Three-hundred-and-seventy consecutive patients (pts) entered this prospective, non-randomized trial in the period January 1993-January 2003; 209 were treated with STD and 161 with HFX CRT. All were evaluable for acute toxicity analysis, 179 (STD) and 151 pts (HFX) being evaluable for late sequelae and bRFS analyses. Pt characteristics were not statistically different in the two groups. CRT consisted of a 4-field technique for prostate and/or pelvic nodes and a 5-field boost with rectal shielding. Median doses were 74 and 79.2 Gy for STD and HFX patients respectively, the latter dose being isoeffective for tumour control assuming α/β=10 (EQD 2 =73.9 Gy). Median follow-up was 29.4 months (25.2 mos for STD; 37.7 mos for HFX; P<0.01). The two regimens were compared in terms of acute and late GU and GI toxicities and 5-year bRFS by univariate and multivariate analyses. Results: Acute grade≥2 GU toxicity was higher in the STD group (48.6% versus 37.3% in HFX, P=0.03), while no significant difference was found for acute GI toxicity. Late grade≥2 GU and GI toxicities were lower in the HFX group (5-year actuarial rate: GU: 10.1% versus 20.3%, P=0.05; GI: 6.0% versus 10.6%, P=0.18). Five-year bRFS were 70% (±13.8%, 95% CI) and 82.6% (±7.2%) for STD and HFX, respectively (P=0.44); a trend favouring HFX was found in the subgroup of pts who did not receive hormonal therapy (5-year bRFS: 85.9%±12.4% versus 63.9%±23.8%, P=0.15). Multivariate analysis revealed only risk groups and age statistically related to bRFS but not fractionation

  12. A non-randomized, open-label, single-arm, Phase 2 study of emibetuzumab in Asian patients with MET diagnostic positive, advanced gastric cancer.

    Science.gov (United States)

    Sakai, Daisuke; Chung, Hyun Cheol; Oh, Do-Youn; Park, Se Hoon; Kadowaki, Shigenori; Kim, Yeul Hong; Tsuji, Akihito; Komatsu, Yoshito; Kang, Yoon-Koo; Uenaka, Kazunori; Wijayawardana, Sameera R; Wacheck, Volker; Wang, Xuejing; Yamamura, Ayuko; Doi, Toshihiko

    2017-12-01

    Mesenchymal-epithelial transition factor (MET) is expressed in gastric cancer and associated with poor clinical outcomes. We assessed activity, safety, and pharmacokinetics of emibetuzumab, a bivalent monoclonal anti-MET antibody that blocks ligand-dependent and ligand-independent MET signaling. This non-randomized, single-arm, Phase 2 study enrolled Asian patients with MET diagnostic positive advanced gastric adenocarcinoma. Emibetuzumab (2000 mg, intravenous) was given on days 1 and 15 (28-day cycle). The primary endpoint was 8-week progression-free survival rate. Secondary objectives included safety, pharmacokinetics, overall survival, and change in tumor size. Tumors from 65 patients were immunohistochemically screened to enroll 15 MET diagnostic positive patients (23% positivity; 8 Japanese, 7 Korean; 10 male). Eight-week progression-free survival rate was 0.47 (70% CI, 0.33-0.59). Disease control rate was 40% (target lesion decreases, three patients; no complete/partial responses according to RECIST). Median overall survival was 17.1 weeks (95% CI, 6.3-not achievable). No serious emibetuzumab-related adverse events or new safety signals emerged. Grade ≥ 3 possibly drug-related adverse events were hyperkalemia, hyponatremia, and hyperuricemia (one each). Emibetuzumab's pharmacokinetics profile was similar to that observed previously. MET expression and clinical outcomes were not obviously associated. Emibetuzumab was well tolerated with limited single-agent activity in advanced gastric adenocarcinoma.

  13. Effects of aerobic interval training on measures of anxiety, depression and quality of life in patients with ischaemic heart failure and an implantable cardioverter defibrillator: A prospective non-randomized trial.

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    Isaksen, Kjetil; Munk, Peter Scott; Giske, Rune; Larsen, Alf Inge

    2016-03-01

    To evaluate the short- and long-term effects of aerobic interval training on quality of life and on symptoms of anxiety and depression among patients with ischaemic heart failure and an implantable cardioverter defibrillator. Prospective, non-randomized controlled study. Patients with ischaemic heart failure and an implantable cardioverter defibrillator, willing to undergo an aerobic interval training programme. A total of 31 patients were enrolled (19 were assigned to the aerobic interval training group and 12 to the control group). The aerobic interval training group performed a 12-week exercise training programme. All patients were evaluated with the Short Form-36 (SF-36), the Hospital Anxiety and Depression Scale (HADS) and the International Physical Activity Questionnaire at baseline, after 12 weeks and at 2 years. The aerobic interval training group showed significant improvements in several SF-36 subscores at 12 weeks. There was an unadjusted significant reduction in the HADS depression (HADS-D) score. At follow-up, results in the aero-bic interval training group moved towards baseline or remained stable, whereas in the control group HADS-D scores and some SF-36 subscores deteriorated. Participation in a 12-week aerobic interval training programme resulted in significant improvements in several measures of quality of life and the unadjusted HADS-D score in patients with ischaemic heart failure with an implantable cardioverter defibrillator. At follow-up there was significantly less sedentary activity in the aerobic interval training group, while psychometric measures were no longer significantly different from baseline.

  14. Relationship of nocturnal concentrations of melatonin, gamma-aminobutyric acid and total antioxidants in peripheral blood with insomnia after stroke: study protocol for a prospective non-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Wei Zhang

    2017-01-01

    Full Text Available Melatonin and gamma-aminobutyric acid (GABA have been shown to regulate sleep. The nocturnal concentrations of melatonin, GABA and total antioxidants may relate to insomnia in stroke patients. In this prospective single-center non-randomized controlled clinical trial performed in the China Rehabilitation Research Center, we analyzed the relationship of nocturnal concentrations of melatonin, GABA and total antioxidants with insomnia after stroke. Patients during rehabilitation of stroke were recruited and assigned to the insomnia group or non-insomnia group. Simultaneously, persons without stroke or insomnia served as normal controls. Each group contained 25 cases. The primary outcome was nocturnal concentrations of melatonin, GABA and total antioxidants in peripheral blood. The secondary outcomes were Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale, Fatigue Severity Scale, Morningness-Eveningness Questionnaire (Chinese version, and National Institute of Health Stroke Scale. The relationship of nocturnal concentrations of melatonin, GABA and total antioxidants with insomnia after stroke was analyzed and showed that they were lower in the insomnia group than in the non-insomnia group. The severity of stroke was higher in the insomnia group than in the non-insomnia group. Correlation analysis demonstrated that the nocturnal concentrations of melatonin and GABA were associated with insomnia after stroke. This trial was registered at ClinicalTrials.gov, identifier: NCT03202121.

  15. Treatment of early AIDS-related Kaposi's sarcoma with oral all-trans-retinoic acid: results of a sequential non-randomized phase II trial. Kaposi's Sarcoma ANRS Study Group. Agence Nationale de Recherches sur le SIDA.

    Science.gov (United States)

    Saiag, P; Pavlovic, M; Clerici, T; Feauveau, V; Nicolas, J C; Emile, D; Chastang, C

    1998-11-12

    To assess the efficacy and safety of all-trans-retinoic acid (ATRA), a retinoid with antitumour activity that inhibits in vitro the growth of Kaposi's sarcoma cells, in patients with low-risk AIDS-associated Kaposi's sarcoma. Non-randomized phase II study, using a group sequential procedure to determine whether the response rate to ATRA was above 10%. Nine referral French centres. Twenty HIV-seropositive men with CD4 cells > or = 200 x 10(6)/l, low-risk Kaposi's sarcoma [T0I0S0 according to the classification of AIDS Clinical Trials Group (ACTG)] not previously treated with systemic anti-Kaposi's sarcoma agents, and with at least four measurable lesions were included. ATRA was given orally 45 mg/m2 daily for 12 weeks. Tumour response evaluated according to ACTG criteria. Nineteen patients were evaluated for response: partial response, stabilization and progression were found in eight (42%), seven (37%), and four (21%) patients, respectively. Gradual flattening and lightening of lesions was observed in responders after at least 2 months of ATRA. All patients with partial response at week 12 pursued ATRA for another 15+/-7 weeks. Further improvement was observed in six patients. Median duration of response was 332 days. Cheilitis, transient headaches and skin dryness were the main toxicities noted. No significant changes in HIV viral burden or serum interleukin-6 pathways were observed. ATRA is well tolerated and effective enough in Kaposi's sarcoma patients to warrant further evaluation.

  16. Subsurface Prospecting by Planetary Drones, Phase I

    Data.gov (United States)

    National Aeronautics and Space Administration — The proposed program innovates subsurface prospecting by planetary drones to seek a solution to the difficulty of robotic prospecting, sample acquisition, and sample...

  17. Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ≥ 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial.

    Science.gov (United States)

    Godeaux, Olivier; Kovac, Martina; Shu, Daniel; Grupping, Katrijn; Campora, Laura; Douha, Martine; Heineman, Thomas C; Lal, Himal

    2017-05-04

    This phase III, non-randomized, open-label, multi-center study (NCT01827839) evaluated the immunogenicity and safety of an adjuvanted recombinant subunit herpes zoster (HZ) vaccine (HZ/su) in adults aged ≥ 50 y with prior physician-documented history of HZ. Participants (stratified by age: 50-59, 60-69 and ≥ 70 y) received 2 doses of HZ/su 2 months apart and were followed-up for another 12 months. Anti-glycoprotein E (gE) antibodies were measured by enzyme-linked immunosorbent assay before vaccination and 1 month after the second dose (Month 3). Solicited local and general adverse events (AEs) were recorded for 7 d and unsolicited AEs for 30 d after each vaccination. Serious AEs were recorded until study end. The primary immunogenicity objective was met if the lower limit of the 95% confidence interval (CI) of the vaccine response rate (VRR), defined as a 4-fold increase in anti-gE over baseline, at Month 3 was ≥ 60%. 96 participants (32/age group) were enrolled. The primary immunogenicity objective was met, as the VRR at Month 3 was 90.2% (95% CI: 81.7-95.7). Geometric mean anti-gE antibody concentrations at Month 3 were similar across age groups. 77.9% and 71.6% of participants reported local and general solicited AEs, respectively. The most frequent solicited AEs were pain at injection site, fatigue, headache, myalgia and shivering. The HZ/su vaccine was immunogenic in adults aged ≥ 50 y with a physician-documented history of HZ, and no safety concerns were identified.

  18. A prospective non-randomized two-centre study of patients with passive faecal incontinence after birth trauma and patients with soiling after anal surgery, treated by elastomer implants versus rectal irrigation

    OpenAIRE

    van der Hagen, S. J.; van der Meer, W.; Soeters, P. B.; Baeten, C. G.; van Gemert, W. G.

    2012-01-01

    Aim This study is a prospective evaluation of patients with passive faecal incontinence and patients with soiling treated by elastomer implants and rectal irrigation. Patients and methods Patients with passive faecal incontinence after birth trauma resulting from a defect of the internal sphincter and patients with soiling after previous anal surgery were included. All patients underwent endo-anal ultrasound, magnetic resonance imaging, and anal manometry. The patients with passive faecal inc...

  19. Non-random patterns in viral diversity

    DEFF Research Database (Denmark)

    Anthony, Simon J.; Islam, Ariful; Johnson, Christine

    2015-01-01

    ) or stochastic (not predictable) processes. We sample macaque faeces across nine sites in Bangladesh and use consensus PCR and sequencing to discover 184 viruses from 14 viral families. We then use network modelling and statistical null-hypothesis testing to show the presence of non-random deterministic patterns...... at different scales, between sites and within individuals. We show that the effects of determinism are not absolute however, as stochastic patterns are also observed. In showing that determinism is an important process in viral community assembly we conclude that it should be possible to forecast changes...

  20. TTI Phase 2 Institutional Support: Initiative Prospective Agricole et ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Sound research, policy influence. TTI is a multi-funder program dedicated to strengthening independent policy research institutions, or think tanks, in developing countries. The program aims to enhance their ability to provide sound research that informs and influences policy. This second TTI phase (2014?2019) will fund 43 ...

  1. TTI Phase 2 Institutional Support: Initiative Prospective Agricole et ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Sound research, policy influence. TTI is a multi-funder program dedicated to ... The program aims to enhance their ability to provide sound research that informs and influences policy. This second TTI phase ... -improve its research quality and quantity with publications in peer-reviewed journals -strengthen researchers' ...

  2. Adjuvant treatment of resectable biliary tract cancer with cisplatin plus gemcitabine: A prospective single center phase II study.

    Science.gov (United States)

    Siebenhüner, Alexander R; Seifert, Heike; Bachmann, Helga; Seifert, Burkhardt; Winder, Thomas; Feilchenfeldt, Jonas; Breitenstein, Stefan; Clavien, Pierre-Alain; Stupp, Roger; Knuth, Alexander; Pestalozzi, Bernhard; Samaras, Panagiotis

    2018-01-11

    Biliary tract cancer (BTC) is a dismal disease, even after curative intent surgery. We conducted this prospective, non-randomized phase II study to evaluate the feasibility and efficacy of cisplatin and gemcitabine as adjuvant treatment in patients with resected BTC. Patients initially received gemcitabine 1000 mg/m 2 alone on days 1, 8 and 15 every 28-days for a total of six cycles (single agent cohort), and after protocol amendment a combination therapy with gemcitabine 1000 mg/m 2 and cisplatin 25 mg/m 2 on days 1 and 8 was administered every 21 days for a total of eight cycles (combined regimen cohort). Treatment was planned to start within eight weeks after curative intent resection. Adverse events, disease-free survival and overall survival were assessed. Overall 30 patients were enrolled in the study from August 2008 and last patient was enrolled at 2nd December 2014. The follow-up of the patients ended at 31st December 2016. The first 9 patients received single-agent gemcitabine. The interim analysis met the predefined feasibility criteria and, from September 2010 on, the second group of 21 patients received the combination of cisplatin plus gemcitabine. In the single-agent cohort with gemcitabine the median relative dose intensity (RDI) was 100% (IQR 88.3-100). Patients treated with the combination cisplatin-gemcitabine received an overall median RDI of 100% (IQR 50-100) for cisplatin and 100% (IQR 75-100) for gemcitabine respectively. The most significant non-hematological adverse events (grade 3 or 4) were fatigue (20%), infections during neutropenia (10%), and two cases of biliary sepsis (7%). Abnormal liver function was seen in 10% of the patients. One patient died due to infectious complications during treatment with cisplatin and gemcitabine. The median disease-free survival (DFS) was 14.9 months (95% CI 0-33.8) with a corresponding 3-year DFS of 43.1 ± 9.1%. The median overall survival (OS) was 40.6 months (95% CI 18.8-62.3) with a 3-year

  3. Migraine headache is present in the aura phase: a prospective study.

    Science.gov (United States)

    Hansen, Jakob M; Lipton, Richard B; Dodick, David W; Silberstein, Stephen D; Saper, Joel R; Aurora, Sheena K; Goadsby, Peter J; Charles, Andrew

    2012-11-13

    Migraine aura is commonly considered to be a distinct phase of a migraine attack that precedes headache. The objective of the study was to examine a large number of prospectively recorded attacks of migraine with aura and determine the timing of headache and other migraine symptoms relative to aura. As part of a clinical trial we collected prospective data on the time course of headache and other symptoms relative to the aura. Patients (n = 267) were enrolled from 16 centers, and asked to keep a headache diary for 1 month (phase I). They were asked to record headache symptoms as soon as possible after aura began and always within 1 hour of aura onset. A total of 456 attacks were reported during phase I by 201 patients. These patients were then randomized and included in phase II, during which a total of 405 attacks were reported in 164 patients. In total, we present data from 861 attacks of migraine with aura from 201 patients. During the aura phase, the majority of attacks (73%) were associated with headache. Other migraine symptoms were also frequently reported during the aura: nausea (51%), photophobia (88%), and photophobia (73%). During the first 15 minutes within the onset of aura, 54% of patients reported headache fulfilling the criteria for migraine. Our results indicate that headaches as well as associated migraine symptoms are present early, during the aura phase of the migraine attack in the majority of patients.

  4. Prospects and challenges of quantitative phase imaging in tumor cell biology

    Science.gov (United States)

    Kemper, Björn; Götte, Martin; Greve, Burkhard; Ketelhut, Steffi

    2016-03-01

    Quantitative phase imaging (QPI) techniques provide high resolution label-free quantitative live cell imaging. Here, prospects and challenges of QPI in tumor cell biology are presented, using the example of digital holographic microscopy (DHM). It is shown that the evaluation of quantitative DHM phase images allows the retrieval of different parameter sets for quantification of cellular motion changes in migration and motility assays that are caused by genetic modifications. Furthermore, we demonstrate simultaneously label-free imaging of cell growth and morphology properties.

  5. Radioembolisation for liver metastases: results from a prospective 151 patient multi-institutional phase II study.

    Science.gov (United States)

    Benson, Al B; Geschwind, Jean-Francois; Mulcahy, Mary F; Rilling, William; Siskin, Gary; Wiseman, Greg; Cunningham, James; Houghton, Bonny; Ross, Mason; Memon, Khairuddin; Andrews, James; Fleming, Chad J; Herman, Joseph; Nimeiri, Halla; Lewandowski, Robert J; Salem, Riad

    2013-10-01

    To investigate the safety, response rate, progression-free and overall survival of patients with liver metastases treated with (90)Y (glass) radioembolisation in a prospective, multicenter phase II study. 151 patients with liver metastases (colorectal n=61, neuroendocrine n=43 and other tumour types n=47) refractory to standard of care therapies were enrolled in this prospective, multicenter, phase II study under an investigational device exemption. Clinical/laboratory/imaging follow-up were obtained at 30 days followed by 3-month intervals for 1 year and every 6 months thereafter. The primary end-point was progression-free survival (PFS); secondary end-points included safety, hepatic progression-free survival (HPFS), response rate and overall survival. Median age was 66 (range 25-88). Grade 3/4 adverse events included pain (12.8%), elevated alkaline phospatase (8.1%), hyperbilirubinemia (5.3%), lymphopaenia (4.1%), ascites (3.4%) and vomiting (3.4%). Treatment parameters including dose delivery were reproducible among centers. Disease control rates were 59%, 93% and 63% for colorectal, neuroendocrine and other primaries, respectively. Median PFS was 2.9 and 2.8 months for colorectal and other primaries, respectively. PFS was not achieved in the neuroendocrine group. Median survival from (90)Y treatment was 8.8 months for colorectal and 10.4 months for other primaries. Median survival for neuroendocrine patients has not been reached. Patients with liver metastases can be safely treated with (90)Y microspheres. This study is the first to demonstrate technical and dose reproducibility of (90)Y glass microspheres between centers in a prospective setting. Based on these promising data, three international, multicenter, randomised phase III studies in colorectal and hepatocellular carcinoma have been initiated. Copyright © 2013 Elsevier Ltd. All rights reserved.

  6. Efficacy and safety of thalidomide for the treatment of severe recurrent epistaxis in hereditary hemorrhagic telangiectasia: results of a prospective phase II clinical trial

    Science.gov (United States)

    Invernizzi, Rosangela; Quaglia, Federica; Klersy, Caherine; Pagella, Fabio; Ornati, Federica; Chu, Francesco; Matti, Elina; Spinozzi, Giuseppe; Plumitallo, Sara; Grignani, Pierangela; Olivieri, Carla; Bastia, Raffaella; Bellistri, Francesca; Danesino, Cesare; Benazzo, Marco; Balduini, Carlo L

    2016-01-01

    Summary Background Hereditary hemorrhagic telangiectasia (HHT) is a genetic disease that leads to multiregional angiodysplasia. Severe recurrent epistaxis is the most common presentation, frequently leading to severe anemia. Multiple therapeutic approaches have been tried, but they are largely palliative with variable results.We aimed to assess the efficacy of thalidomide in reducing epistaxis in patients with HHT refractory to standard therapy. Methods HHT patients with severe recurrent epistaxis refractory to mini-invasive surgical procedures were included in an open label, phase II, prospective, non-randomized, single-centre study. Thalidomide was administered at a starting dose of 50 mg/day orally. In the event of no response, thalidomide dosage was increased by 50 mg/day every four weeks until response to a maximum dose of 200 mg/day. After response achievement, patients were treated for eight to16 additional weeks. Monthly follow-up was based on the epistaxis severity score and transfusion need, with adverse events being reported (ClinicalTrials.gov Identifier: NCT01485224). Findings Thirty-one patients, mean age 62∙6 (SD 11∙1) years, were enrolled (median follow-up 15∙9 months, 25th-75th 10∙1-22∙3). Treatment induced cessation of bleeding in three cases (9∙7%) and a significant decrease in all epistaxis parameters in 28 cases (90∙3%). Twenty-five patients (80∙7%) obtained remission with 50 mg/day of thalidomide, five (16∙1%) with 100 mg/day and one (3∙2%) with 150 mg/day. Treatment significantly increased hemoglobin levels (pepistaxis in HHT patients, allowing for a rapid, often durable clinical improvement. Funding Telethon Foundation PMID:26686256

  7. Reducing bias in survival under non-random temporary emigration

    Science.gov (United States)

    Peñaloza, Claudia L.; Kendall, William L.; Langtimm, Catherine Ann

    2014-01-01

    Despite intensive monitoring, temporary emigration from the sampling area can induce bias severe enough for managers to discard life-history parameter estimates toward the terminus of the times series (terminal bias). Under random temporary emigration unbiased parameters can be estimated with CJS models. However, unmodeled Markovian temporary emigration causes bias in parameter estimates and an unobservable state is required to model this type of emigration. The robust design is most flexible when modeling temporary emigration, and partial solutions to mitigate bias have been identified, nonetheless there are conditions were terminal bias prevails. Long-lived species with high adult survival and highly variable non-random temporary emigration present terminal bias in survival estimates, despite being modeled with the robust design and suggested constraints. Because this bias is due to uncertainty about the fate of individuals that are undetected toward the end of the time series, solutions should involve using additional information on survival status or location of these individuals at that time. Using simulation, we evaluated the performance of models that jointly analyze robust design data and an additional source of ancillary data (predictive covariate on temporary emigration, telemetry, dead recovery, or auxiliary resightings) in reducing terminal bias in survival estimates. The auxiliary resighting and predictive covariate models reduced terminal bias the most. Additional telemetry data was effective at reducing terminal bias only when individuals were tracked for a minimum of two years. High adult survival of long-lived species made the joint model with recovery data ineffective at reducing terminal bias because of small-sample bias. The naïve constraint model (last and penultimate temporary emigration parameters made equal), was the least efficient, though still able to reduce terminal bias when compared to an unconstrained model. Joint analysis of several

  8. Acute social stress before the planning phase improves memory performance in a complex real life-related prospective memory task.

    Science.gov (United States)

    Glienke, Katharina; Piefke, Martina

    2016-09-01

    Successful execution of intentions, but also the failure to recall are common phenomena in everyday life. The planning, retention, and realization of intentions are often framed as the scientific concept of prospective memory. The current study aimed to examine the influence of acute stress on key dimensions of complex "real life" prospective memory. To this end, we applied a prospective memory task that involved the planning, retention, and performance of intentions during a fictional holiday week. Forty healthy males participated in the study. Half of the subjects were stressed with the Socially Evaluated Cold Pressor Test (SECPT) before the planning of intentions, and the other half of the participants underwent a control procedure at the same time. Salivary cortisol was used to measure the effectiveness of the SECPT stress induction. Stressed participants did not differ from controls in planning accuracy. However, when we compared stressed participants with controls during prospective memory retrieval, we found statistically significant differences in PM across the performance phase. Participants treated with the SECPT procedure before the planning phase showed improved prospective memory retrieval over time, while performance of controls declined. Particularly, there was a significant difference between the stress and control group for the last two days of the holiday week. Interestingly, control participants showed significantly better performance for early than later learned items, which could be an indicator of a primacy effect. This differential effect of stress on performance was also found in time- and event-dependent prospective memory. Our results demonstrate for the first time, that acute stress induced before the planning phase may improve prospective memory over the time course of the performance phase in time- and event-dependent prospective memory. Our data thus indicate that prospective memory can be enhanced by acute stress. Copyright © 2016

  9. 42 CFR 421.505 - Termination and extension of non-random prepayment complex medical review.

    Science.gov (United States)

    2010-10-01

    ... prepayment complex medical review. If the reduction in the error rate is attributed to a 25 percent or... error are no longer suspended for non-random prepayment complex medical review. (d) Periodic re... that appears to have resumed a high level of payment error on non-random prepayment complex medical...

  10. Search for non-random features in arrival times of air showers

    International Nuclear Information System (INIS)

    Ochi, N.; Wada, T.; Yamashita, Y.; Ohashi, A.; Okada, T.; Yamamoto, I.; Nakatsuka, T.

    2001-01-01

    It was searched for non-random components in arrival times of air showers of mean energy of 1 PeV. By counting the number of air showers observed within time windows of 20-60 minutes, it was found small deviation of air shower data from the conventional view of uniformly random cosmic ray injection. The arrival directions of the non-random events concentrate at the direction of the Galactic plane. Though the significance of these events is not so high because of the lack of statistics, they may be induced by sporadic non-random injection of ultra-high energy γ-rays from the Galactic plane

  11. Prospective

    International Nuclear Information System (INIS)

    Wagner, H.N. Jr.

    1984-01-01

    All living systems are characterized by an S-shaped growth curve, representing a lag phase, a phase of exponential growth and a plateau. Nuclear medicine is no exception. In one sense, medical imaging modalities, such as plain film and contrast studies, computerized tomography (CT), ultrasound, digital subtraction angiography, conventional nuclear imaging, and PET, are competitive. They compete for space, funds, people, enthusiasm, and interest. For example, in the 1970s the use of radionuclide brain scans dropped sharply in hospitals when CT became available; ultrasound and nuclear medicine studies of the biliary system led to a significant decrease in the use of oral cholecystograpy and intravenous cholangiography. Some predict that nuclear magnetic resonance (NMR) and digital radiography may have a significant impact on CT scanning by 1990, because current NMR images are comparable in anatomic resolution to CT without bone artifacts and, especially important in the 1980s, without ionizing radiation. In the face of all this competition, the continued growth and well-being of the field of nuclear medicine will depend on the degree to which the field can adapt itself to the changing circumstances of medical practice and research in the 1980s. The forces that will shape the future of nuclear medicine will continue to come from both within and outside the field

  12. 3T phased array MRI improves the presurgical evaluation in focal epilepsies: a prospective study.

    Science.gov (United States)

    Knake, S; Triantafyllou, C; Wald, L L; Wiggins, G; Kirk, G P; Larsson, P G; Stufflebeam, S M; Foley, M T; Shiraishi, H; Dale, A M; Halgren, E; Grant, P E

    2005-10-11

    Although detection of concordant lesions on MRI significantly improves postsurgical outcomes in focal epilepsy (FE), many conventional MR studies remain negative. The authors evaluated the role of phased array surface coil studies performed at 3 Tesla (3T PA MRI). Forty patients with medically intractable focal epilepsies were prospectively imaged with 3T PA-MRI including high matrix TSE T2, fluid attenuated inversion recovery, and magnetization prepared rapid gradient echo. All patients were considered candidates for epilepsy surgery. 3T PA-MRIs were reviewed by a neuroradiologist experienced in epilepsy imaging with access to clinical information. Findings were compared to reports of prior standard 1.5T MRI epilepsy studies performed at tertiary care centers. Experienced, unblinded review of 3T PA-MRI studies yielded additional diagnostic information in 48% (19/40) compared to routine clinical reads at 1.5T. In 37.5% (15/40), this additional information motivated a change in clinical management. In the subgroup of patients with prior 1.5T MRIs interpreted as normal, 3T PA-MRI resulted in the detection of a new lesion in 65% (15/23). In the subgroup of 15 patients with known lesions, 3T PA-MRI better defined the lesion in 33% (5/15). Phased array surface coil studies performed at 3 Tesla read by an experienced unblinded neuroradiologist can improve the presurgical evaluation of patients with focal epilepsy when compared to routine clinical 1.5T studies read at tertiary care centers.

  13. Parametric Optimization and Prediction Tool for Excavation and Prospecting Tasks, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Honeybee Robotics therefore proposed to develop a software tool for facilitating prospecting and excavation system trades in support of selecting an optimal...

  14. AstroCube: An Asteroid Prospecting CubeSat Mission, Phase I

    Data.gov (United States)

    National Aeronautics and Space Administration — Busek, in partnership with Arizona State University (ASU), proposes to develop a robotic resource prospecting mission to a near-Earth asteroid using a 6U CubeSat,...

  15. Optimal scheme of postoperative chemoradiotherapy in rectal cancer: phase III prospective randomized trial

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Young Seok; Kim, Jong Hoon; Choi, Eun Kyung [College of Medicine, University of Ulsan, Seoul (Korea, Republic of)] (and others)

    2002-03-15

    To determine the optimal scheme of postoperative chemoradiotherapy in rectal cancer by comparing survival, patterns of failure, toxicities in early and late radiotherapy groups using a phase III randomized prospective clinical trial. From January 1996 to March 1999, 307 patients with curatively resected AJCC stage II and III rectal cancer were assigned randomly to an 'early (151 patients, arm I)' or a 'late (156 patients, arm II)' and were administered combined chemotherapy (5-FU 375 mg/m{sup 2}/day, leucovorin 20 mg/m{sup 2}, IV bolus daily, for 3 days with RT, 5 days without RT, 8 cycles with 4 weeks interval) and radiation therapy (whole pelvis with 45 Gy/25 fractions/5 weeks). Patients of arm I received radiation therapy from day 1 of the first cycle of chemotherapy and those of arm II from day 57 with a third cycle of chemotherapy. The median follow-up period of living patients was 40 months. Of the 307 patients enrolled, fifty patients did not receive scheduled radiation therapy or chemotherapy. The overall survival rate and disease free survival rate at 5 years were 78.3% and 68.7% in arm I, and 78.4% and 67.5% in arm II. The local recurrence rate was 6.6% and 6.4% ({rho} = 0.46) in arms I and II, respectively, no significant difference was observed between the distant metastasis rates of the two arms (23.8% and 29.5%, {rho} = 0.16). During radiation therapy, grade 3 diarrhea or more, by the NCI common toxicity criteria, was observed in 63.0% and 58.2% of the respective arms ({rho} = N.S.), but most were controlled with supportive care. Hematologic toxicity (leukopenia) greater than RTOG grade 2 was found in only 1.3% and 2.6% of patients in each respective arm. There was no significant difference in survival, patterns of failure or toxicities between the early and late radiation therapy arms. Postoperative adjuvant chemoradiation was found to be a relatively safe treatment but higher compliance is needed.

  16. Non-random autosome segregation : A stepping stone for the evolution of sex chromosome complexes?

    NARCIS (Netherlands)

    Schwander, Tanja; Beukeboom, Leo W.

    A new study in Caenorhabditis elegans shows that homologous autosomes segregate non-randomly with the sex chromosome in the heterogametic sex. Segregation occurs according to size, small autosomes segregating with, and large autosomes segregating away from the X-chromosome. Such sex-biased

  17. Prospective phase II trial of image-guided radiotherapy in Hodgkin lymphoma

    DEFF Research Database (Denmark)

    Petersen, Peter M; Aznar, Marianne C; Berthelsen, Anne K

    2015-01-01

    BACKGROUND: Long-term Hodgkin lymphoma (HL) survivors have an increased risk of late cardiac morbidity and secondary lung cancer after chemotherapy and mediastinal radiotherapy. In this prospective study we investigate whether radiotherapy with deep inspiration breath-hold (DIBH) can reduce...... in radiotherapy for patients with mediastinal HL....

  18. Prospects for versatile phase manipulation in the TEM: Beyond aberration correction

    International Nuclear Information System (INIS)

    Guzzinati, Giulio; Clark, Laura; Béché, Armand; Juchtmans, Roeland; Van Boxem, Ruben; Mazilu, Michael; Verbeeck, Jo

    2015-01-01

    In this paper we explore the desirability of a transmission electron microscope in which the phase of the electron wave can be freely controlled. We discuss different existing methods to manipulate the phase of the electron wave and their limitations. We show how with the help of current techniques the electron wave can already be crafted into specific classes of waves each having their own peculiar properties. Assuming a versatile phase modulation device is feasible, we explore possible benefits and methods that could come into existence borrowing from light optics where the so-called spatial light modulators provide programmable phase plates for quite some time now. We demonstrate that a fully controllable phase plate building on Harald Rose's legacy in aberration correction and electron optics in general would open an exciting field of research and applications. - Highlights: • We offer a review of available phase manipulation techniques. • We demonstrate a method for producing Airy waves through aberration manipulation. • We outline hypothetical applications of arbitrary phase manipulation methods

  19. Free-Flying Unmanned Robotic Spacecraft for Asteroid Resource Prospecting and Characterization, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In Phase 2 we will develop a fully integrated, autonomous free-flying robotic system based on a commercial SkyJib quadcopter, and demonstrate flying straight and...

  20. Towards a phase-locked superconducting integrated receiver: prospects and limitations

    DEFF Research Database (Denmark)

    Koshelets, V.P.; Shitov, S.V.; Dmitriev, P.N.

    2002-01-01

    Presently a Josephson flux flow oscillator (FFO) appears to be the most developed superconducting on-chip local oscillator for integrated submillimeter-wave SIS receivers. The feasibility of phase locking the FFO to an external reference oscillator at all frequencies of interest has to be proven...... compared to theory in order to optimize the FFO design. The influence of FFO parameters on radiation linewidth, particularly the effect of the differential resistances associated both with the bias current and the applied magnetic field, has been studied. Two integrated receiver concepts with phase...

  1. Impact of acute-phase complications and interventions on 6-month survival after stroke. A prospective observational study.

    Science.gov (United States)

    Di Carlo, Antonio; Lamassa, Maria; Franceschini, Marco; Bovis, Francesca; Cecconi, Lorenzo; Pournajaf, Sanaz; Paravati, Stefano; Biggeri, Annibale; Inzitari, Domenico; Ferro, Salvatore

    2018-01-01

    The outcome of stroke patients is complex and multidimensional. We evaluated the impact of acute-phase variables, including clinical state, complications, resource use and interventions, on 6-month survival after first-ever stroke, taking into account baseline conditions exerting a possible effect on outcome. As part of a National Research Program, we performed a prospective observational study of acute stroke patients in four Italian Regions. Consecutive patients admitted for a period of 3 months to the emergency rooms of participating hospitals were included. A total of 1030 patients were enrolled (median age 76.0 years, 52.1% males). At 6 months, 816 (79.2%) were alive, and 164 (15.9%) deceased. Survival status at the 6-month follow-up was missing for 50 (4.9%). Neurological state in the acute phase was significantly worse in patients deceased at 6 months, who showed also higher frequency of acute-phase complications. Cox regression analysis adjusted for demographics, pre-stroke function, baseline diseases and risk factors, indicated as significant predictors of 6-month death altered consciousness (HR, 1.70; 95% CI, 1.14-2.53), total anterior circulation infarct (HR, 2.13; 95% CI, 1.44-3.15), hyperthermia (HR, 1.70; 95% CI, 1.18-2.45), pneumonia (HR, 1.76; 95% CI, 1.18-2.61), heart failure (HR, 2.87; 95% CI, 1.34-6.13) and nasogastric feeding (HR, 2.35; 95% CI, 1.53-3.60), while antiplatelet therapy during acute phase (HR, 0.56; 95% CI, 0.39-0.79), and early mobilisation (HR, 0.55; 95% CI, 0.36-0.84) significantly increased 6-month survival. In a prospective observational study, stroke severity and some acute-phase complications, potentially modifiable, significantly increased the risk of 6-month death, independently of baseline variables. Early mobilisation positively affected survival, highlighting the role of early rehabilitation after stroke.

  2. Towards a phase-locked superconducting integrated receiver: prospects and limitations

    DEFF Research Database (Denmark)

    Koshelets, V.P.; Shitov, S.V.; Dmitriev, P.N.

    2002-01-01

    linewidth at higher voltages due to an abrupt increase of the internal damping considerably complicates phase locking of the FFO. Comprehensive measurements of the FFO radiation linewidth have been performed using an integrated harmonic SIS mixer. Results on FFO linewidth and spectral line profile have been...

  3. Non-random distribution of instability-associated chromosomal rearrangement breakpoints in human lymphoblastoid cells

    International Nuclear Information System (INIS)

    Moore, Stephen R.; Papworth, David; Grosovsky, Andrew J.

    2006-01-01

    Genomic instability is observed in tumors and in a large fraction of the progeny surviving irradiation. One of the best-characterized phenotypic manifestations of genomic instability is delayed chromosome aberrations. Our working hypothesis for the current study was that if genomic instability is in part attributable to cis mechanisms, we should observe a non-random distribution of chromosomes or sites involved in instability-associated rearrangements, regardless of radiation quality, dose, or trans factor expression. We report here the karyotypic examination of 296 instability-associated chromosomal rearrangement breaksites (IACRB) from 118 unstable TK6 human B lymphoblast, and isogenic derivative, clones. When we tested whether IACRB were distributed across the chromosomes based on target size, a significant non-random distribution was evident (p < 0.00001), and three IACRB hotspots (chromosomes 11, 12, and 22) and one IACRB coldspot (chromosome 2) were identified. Statistical analysis at the chromosomal band-level identified four IACRB hotspots accounting for 20% of all instability-associated breaks, two of which account for over 14% of all IACRB. Further, analysis of independent clones provided evidence within 14 individual clones of IACRB clustering at the chromosomal band level, suggesting a predisposition for further breaks after an initial break at some chromosomal bands. All of these events, independently, or when taken together, were highly unlikely to have occurred by chance (p < 0.000001). These IACRB band-level cluster hotspots were observed independent of radiation quality, dose, or cellular p53 status. The non-random distribution of instability-associated chromosomal rearrangements described here significantly differs from the distribution that was observed in a first-division post-irradiation metaphase analysis (p = 0.0004). Taken together, these results suggest that genomic instability may be in part driven by chromosomal cis mechanisms

  4. Non-random mating and convergence over time for mental health, life satisfaction, and personality: the Nord-Trøndelag Health Study.

    Science.gov (United States)

    Ask, Helga; Idstad, Mariann; Engdahl, Bo; Tambs, Kristian

    2013-03-01

    Earlier studies have shown evidence for various sources of observed spousal similarity regarding different traits and characteristics. We explored the relative contribution of non-random mating and convergence to spouse similarity with respect to global mental health, life satisfaction, optimism, and type A personality. We used population-based data collected for the Nord-Trøndelag Health Study (1984-1986) and prospective registry information about when and with whom people entered into marriage/cohabitation between 1970 and 2000 for 19,599 married/cohabitating couples and 1,551 future couples that entered into marriage/cohabitation during the 16 years after data collection. Couples were categorized by interval between data collection and entry into marriage/cohabitation. Age-adjusted polychoric correlations calculated for each group were used as the dependent variables in non-linear, segmented regression analysis, with time since or until marriage/cohabitation as the independent variable. Initial correlations between partners-to-be were low to moderate, typically around one-half of the values estimated in existing couples, indicating both non-random mating and early convergence. There appeared to be moderate divergence during the first 20 years of marriage/cohabitation and moderate convergence during the rest of life.

  5. Meta-analysis of non-randomized studies in interventional cardiology: a critical appraisal

    Directory of Open Access Journals (Sweden)

    Eliano Pio Navarese

    2009-12-01

    Full Text Available Utilisation of meta-analysis is becoming more and more common in interventional cardiology. The aim of this statistical approach is to collect a large number of patients from randomized clinical studies and nonrandomized registries in order to obtain a pooled estimate of the results. Nevertheless, simply pooling these results without a correct methodological approach can easily lead to biased conclusions. In this report we analyse the possible methodological drawbacks of such an approach and we suggest a simplified check-list of items to be considered in the effort of building-up a meta-analysis from non-randomized studies.

  6. Prospects and applications near ferroelectric quantum phase transitions: a key issues review

    Science.gov (United States)

    Chandra, P.; Lonzarich, G. G.; Rowley, S. E.; Scott, J. F.

    2017-11-01

    The emergence of complex and fascinating states of quantum matter in the neighborhood of zero temperature phase transitions suggests that such quantum phenomena should be studied in a variety of settings. Advanced technologies of the future may be fabricated from materials where the cooperative behavior of charge, spin and current can be manipulated at cryogenic temperatures. The progagating lattice dynamics of displacive ferroelectrics make them appealing for the study of quantum critical phenomena that is characterized by both space- and time-dependent quantities. In this key issues article we aim to provide a self-contained overview of ferroelectrics near quantum phase transitions. Unlike most magnetic cases, the ferroelectric quantum critical point can be tuned experimentally to reside at, above or below its upper critical dimension; this feature allows for detailed interplay between experiment and theory using both scaling and self-consistent field models. Empirically the sensitivity of the ferroelectric T c’s to external and to chemical pressure gives practical access to a broad range of temperature behavior over several hundreds of Kelvin. Additional degrees of freedom like charge and spin can be added and characterized systematically. Satellite memories, electrocaloric cooling and low-loss phased-array radar are among possible applications of low-temperature ferroelectrics. We end with open questions for future research that include textured polarization states and unusual forms of superconductivity that remain to be understood theoretically.

  7. Prospective 2-Year Study of Emergency Department Patients With Early-Phase Primary Psychosis or Substance-Induced Psychosis

    Science.gov (United States)

    Drake, Robert E.; Caton, Carol L.M.; Xie, Haiyi; Hsu, Eustace; Gorroochurn, Prakash; Samet, Sharon; Hasin, Deborah S.

    2013-01-01

    Objective The authors examined treatment utilization and outcomes over 2 years among patients admitted to emergency departments with early-phase primary or substance-induced psychosis. The main hypothesis was that patients with substance-induced psychosis would have a more benign course of illness than those with primary psychosis. Method Using a prospective naturalistic cohort study design, the authors compared 217 patients with early-phase primary psychosis plus substance use and 134 patients with early-phase substance-induced psychosis who presented to psychiatric emergency departments at hospitals in Upper Manhattan. Assessments at baseline and at 6, 12, 18, and 24 months included psychiatric diagnoses, service use, and institutional outcomes using the Psychiatric Research Interview for Substance and Mental Disorders; psychiatric symptoms using the Positive and Negative Syndrome Scale; social, vocational, and family functioning using the World Health Organization Psychiatric Disability Assessment Schedule; and life satisfaction using the Quality of Life Interview. Longitudinal analyses were conducted using generalized estimating equations. Results Participants with primary psychosis were more likely to receive antipsychotic and mood-stabilizing medications, undergo hospitalizations, and have out-patient psychiatric visits; those with substance-induced psychosis were more likely to receive addiction treatments. Only a minority of each group received minimally adequate treatments. Both groups improved significantly over time on substance dependence, psychotic symptoms, homelessness, and psychosocial outcomes, and few group-by-time interactions emerged. Conclusions Patients presenting to Upper Manhattan emergency departments with either early-phase primary psychosis or substance-induced psychosis improved steadily over 2 years despite minimal use of mental health and substance abuse services. PMID:21454918

  8. Effect of non-random mating on genomic and BLUP selection schemes

    Directory of Open Access Journals (Sweden)

    Nirea Kahsay G

    2012-04-01

    Full Text Available Abstract Background The risk of long-term unequal contribution of mating pairs to the gene pool is that deleterious recessive genes can be expressed. Such consequences could be alleviated by appropriately designing and optimizing breeding schemes i.e. by improving selection and mating procedures. Methods We studied the effect of mating designs, random, minimum coancestry and minimum covariance of ancestral contributions on rate of inbreeding and genetic gain for schemes with different information sources, i.e. sib test or own performance records, different genetic evaluation methods, i.e. BLUP or genomic selection, and different family structures, i.e. factorial or pair-wise. Results Results showed that substantial differences in rates of inbreeding due to mating design were present under schemes with a pair-wise family structure, for which minimum coancestry turned out to be more effective to generate lower rates of inbreeding. Specifically, substantial reductions in rates of inbreeding were observed in schemes using sib test records and BLUP evaluation. However, with a factorial family structure, differences in rates of inbreeding due mating designs were minor. Moreover, non-random mating had only a small effect in breeding schemes that used genomic evaluation, regardless of the information source. Conclusions It was concluded that minimum coancestry remains an efficient mating design when BLUP is used for genetic evaluation or when the size of the population is small, whereas the effect of non-random mating is smaller in schemes using genomic evaluation.

  9. Non-random biodiversity loss underlies predictable increases in viral disease prevalence.

    Science.gov (United States)

    Lacroix, Christelle; Jolles, Anna; Seabloom, Eric W; Power, Alison G; Mitchell, Charles E; Borer, Elizabeth T

    2014-03-06

    Disease dilution (reduced disease prevalence with increasing biodiversity) has been described for many different pathogens. Although the mechanisms causing this phenomenon remain unclear, the disassembly of communities to predictable subsets of species, which can be caused by changing climate, land use or invasive species, underlies one important hypothesis. In this case, infection prevalence could reflect the competence of the remaining hosts. To test this hypothesis, we measured local host species abundance and prevalence of four generalist aphid-vectored pathogens (barley and cereal yellow dwarf viruses) in a ubiquitous annual grass host at 10 sites spanning 2000 km along the North American West Coast. In laboratory and field trials, we measured viral infection as well as aphid fecundity and feeding preference on several host species. Virus prevalence increased as local host richness declined. Community disassembly was non-random: ubiquitous hosts dominating species-poor assemblages were among the most competent for vector production and virus transmission. This suggests that non-random biodiversity loss led to increased virus prevalence. Because diversity loss is occurring globally in response to anthropogenic changes, such work can inform medical, agricultural and veterinary disease research by providing insights into the dynamics of pathogens nested within a complex web of environmental forces.

  10. [Can venous iron and tranexamic acid reduce the transfusion need? Report on a non randomized, case control study].

    Science.gov (United States)

    Essola, L; Kouégnigan Rérambiah, L; Obame, R; Issembè, H; Sima Zué, A

    2017-06-01

    To evaluate if the association of injectable iron and tranexamic acid allows a significant saving in transfusion, in cases of myomectomies and hysterectomies. This is a prospective, non randomized study done over 8 months (from January 2013 to August 2013). Were included, patients undergoing hysterectomy or myomectomy who had a hemoglobin level greater than or equal to 8g/dl and less than 12g/dl. Two groups were compared: group A consisting of patients for whom a pack red cells was ordered and the group B which patients received intravenous iron preoperatively and tranexamic acid perioperatively. The level of hemoglobin, pre- and postoperative, the average number of blood units per patient and estimated blood loss was compared. The transfusion economy was evaluated. During this period, 87 patients with a mean age of 40±9 years (range: 23 and 70years) were included according to our criteria: 44 patients in group A and 43 patients in group B. Initial mean hemoglobin in both groups was 9.1±0.7g/dl. In group B, after iron administration, the mean hemoglobin was 11.3±0.7g/dl. The average number of red blood cells received intraoperative patient in group A was 1.54±0.51. The estimated blood loss was significant greater (P=0.0002) in group A (571.6±237.1ml) than in group B (213.7±131.7ml). No transfusion was performed in group B. The association intravenous iron and tranexamic acid resulted in the reduction of transfusion requirements in our setting. It could be integrated in the strategy for sparing blood transfusion in scheduled surgery with hemorrhagic risks. Copyright © 2017. Published by Elsevier SAS.

  11. The role of geochemical prospecting in phased uranium exploration. A case history

    International Nuclear Information System (INIS)

    Smith, A.Y.; Armour-Brown, A.; Olsen, H.; Lundberg, B.; Niesen, P.L.

    1976-01-01

    The commencement of a UNDP/IAEA uranium exploration project in Northern Greece in 1971 offered the opportunity to test and apply an exploration strategy based on a phased use of geochemical exploration methods. The paper reviews the exploration task, the strategy selected, and some results obtained. The project area (22000 km 2 ) was explored by car-borne survey, covering 15000 km of road and track. Concurrently, a stream sediment geochemical survey was begun which aimed at a nominal sample density of one sample per square kilometre. Samples were analysed for copper, lead, zinc, silver, cobalt, nickel, molybdenum, mercury and manganese, in addition to uranium. At each site, a general reading of radioactivity was made, and treated like another element analysis. The reconnaissance programme succeeded in delineating a number of important target areas, varying in size from a few to several hundred square kilometres with significant uranium potential. Follow-up and detailed surveys have been carried out over a number of these, including a sedimentary basin of continental deposits which have been found to contain occurrences of secondary uranium minerals, and two areas in which granitic bodies have been found to have fracture systems and secondary uranium mineralization of economic interest. In no case has sufficient work been yet done to prove economic deposits of uranium. The phased strategy used has, however, already been demonstrated to be effective in the environment of northern Greece. (author)

  12. Cortisol evaluation during the acute phase of traumatic brain injury-A prospective study.

    Science.gov (United States)

    Bensalah, Meriem; Donaldson, Malcolm; Aribi, Yamina; Iabassen, Malek; Cherfi, Lyes; Nebbal, Mustapha; Medjaher, Meriem; Haffaf, ElMehdi; Abdennebi, Benaissa; Guenane, Kamel; Djermane, Adel; Kemali, Zahra; OuldKablia, Samia

    2018-05-01

    Biochemical diagnosis of adrenal insufficiency (AI) is difficult in the context of traumatic brain injury (TBI). To assess the frequency and predictive factors of AI in victims of TBI from Algiers. Between November 2009 and December 2013, TBI victims had a single 8-9 am serum cortisol measurement during the acute postinjury period (0-7 days). AI was defined according to basal cortisol levels of 83, 276 and 414 nmol/L. Variables studied were TBI severity according to Glasgow coma scale, duration of intubation and coma, pupillary status, hypotension, anaemia, brain imaging findings, diabetes insipidus and medication. Insulin tolerance test was performed during the recovery phase, defining AI as peak cortisol 414 nmol/L. Hydrocortisone replacement is advised in TBI patients with morning cortisol <276 nmol/L or those <414 nmol/L with additional risk factors for AI. As acute and subsequent AI are poorly correlated, patients with moderate/severe TBI require adrenal re-evaluation during the recovery phase. © 2018 John Wiley & Sons Ltd.

  13. A search for non-random cosmic-ray time series by a cluster analysis

    International Nuclear Information System (INIS)

    Katayose, Y.; Inoue, Y.; Kawasaki, Y.; Miyoshi, H.; Murakami, S.; Nakagawa, M.; Nakakoji, T.; Nakano, E.; Takahashi, T.; Teramoto, Y.

    1998-01-01

    Non-random time series of cosmic rays were searched for in air shower data of mean energy 1.1 X 10 15 eV, collected by the air shower array at Mitsuishi, Japan, during the period from January 1989 to October 1996. By clustering the arrival time of air showers, five occasions of rate elevation phenomena were found with an expected probability ≤ 0.05 (varying from 0.18 X 10 -2 to 4.0 X 10 -2 ) from a random distribution in 3651358 air showers. The arrival directions of these events are grouped in two regions on the galactic plane within the latitude ±25 degrees, corresponding to a chance probability of 1.6% from a uniform distribution

  14. Non-random food-web assembly at habitat edges increases connectivity and functional redundancy.

    Science.gov (United States)

    Peralta, Guadalupe; Frost, Carol M; Didham, Raphael K; Rand, Tatyana A; Tylianakis, Jason M

    2017-04-01

    Habitat fragmentation dramatically alters the spatial configuration of landscapes, with the creation of artificial edges affecting community structure and dynamics. Despite this, it is not known how the different food webs in adjacent habitats assemble at their boundaries. Here we demonstrate that the composition and structure of herbivore-parasitoid food webs across edges between native and plantation forests are not randomly assembled from those of the adjacent communities. Rather, elevated proportions of abundant, interaction-generalist parasitoid species at habitat edges allowed considerable interaction rewiring, which led to higher linkage density and less modular networks, with higher parasitoid functional redundancy. This was despite high overlap in host composition between edges and interiors. We also provide testable hypotheses for how food webs may assemble between habitats with lower species overlap. In an increasingly fragmented world, non-random assembly of food webs at edges may increasingly affect community dynamics at the landscape level. © 2016 by the Ecological Society of America.

  15. Macroscopic Hematuria After Conventional or Hypofractionated Radiation Therapy: Results From a Prospective Phase 3 Study

    Energy Technology Data Exchange (ETDEWEB)

    Sanguineti, Giuseppe, E-mail: sanguineti@ifo.it [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Arcidiacono, Fabio [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Landoni, Valeria [Department of Physics, Regina Elena National Cancer Institute, Rome (Italy); Saracino, Bianca Maria; Farneti, Alessia; Arcangeli, Stefano; Petrongari, Maria Grazia; Gomellini, Sara [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Strigari, Lidia [Department of Physics, Regina Elena National Cancer Institute, Rome (Italy); Arcangeli, Giorgio [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy)

    2016-10-01

    Purpose: To assess the macroscopic hematuria rates within a single-institution randomized phase 3 trial comparing dose-escalated, conventionally fractionated radiation therapy (CFRT) and moderately hypofractionated radiation therapy (MHRT) for localized prostate cancer. Methods and Materials: Patients with intermediate- to high-risk localized prostate cancer were treated with conformal RT and short-course androgen deprivation. Both the prostate and the entire seminal vesicles were treated to 80 Gy in 40 fractions over 8 weeks (CFRT) or 62 Gy in 20 fractions over 5 weeks (MHRT). The endpoint of the present study was the development of any episode or grade of macroscopic hematuria. The median follow-up period was 93 months (range 6-143). Results: Macroscopic hematuria was reported by 25 of 168 patients (14.9%). The actuarial estimate of hematuria at 8 years was 17.0% (95% confidence interval [CI] 10.7%-23.3%). The number of patients with hematuria was 6 and 19 in the CFRT and MHRT arms, respectively, for an actuarial 8-year estimate of 9.7% and 24.3%, respectively (hazard ratio 3.468, 95% CI 1.385-8.684; P=.008). Overall, 8 of 25 patients were found to have biopsy-proven urothelial carcinoma (3 in the CFRT arm and 5 in the MHRT arm; P=.27). Thus, the 8-year actuarial incidence of macroscopic hematuria (after censoring urothelial cancer–related episodes) was 4.1% and 18.2% after CFRT and MHRT, respectively (hazard ratio 4.961, 95% CI 1.426-17.263; P=.012). The results were confirmed by multivariate analysis after accounting for several patient-, treatment-, and tumor-related covariates. Conclusions: MHRT was associated with a statistically significant increased risk of macroscopic hematuria compared with CFRT.

  16. Macroscopic Hematuria After Conventional or Hypofractionated Radiation Therapy: Results From a Prospective Phase 3 Study

    International Nuclear Information System (INIS)

    Sanguineti, Giuseppe; Arcidiacono, Fabio; Landoni, Valeria; Saracino, Bianca Maria; Farneti, Alessia; Arcangeli, Stefano; Petrongari, Maria Grazia; Gomellini, Sara; Strigari, Lidia; Arcangeli, Giorgio

    2016-01-01

    Purpose: To assess the macroscopic hematuria rates within a single-institution randomized phase 3 trial comparing dose-escalated, conventionally fractionated radiation therapy (CFRT) and moderately hypofractionated radiation therapy (MHRT) for localized prostate cancer. Methods and Materials: Patients with intermediate- to high-risk localized prostate cancer were treated with conformal RT and short-course androgen deprivation. Both the prostate and the entire seminal vesicles were treated to 80 Gy in 40 fractions over 8 weeks (CFRT) or 62 Gy in 20 fractions over 5 weeks (MHRT). The endpoint of the present study was the development of any episode or grade of macroscopic hematuria. The median follow-up period was 93 months (range 6-143). Results: Macroscopic hematuria was reported by 25 of 168 patients (14.9%). The actuarial estimate of hematuria at 8 years was 17.0% (95% confidence interval [CI] 10.7%-23.3%). The number of patients with hematuria was 6 and 19 in the CFRT and MHRT arms, respectively, for an actuarial 8-year estimate of 9.7% and 24.3%, respectively (hazard ratio 3.468, 95% CI 1.385-8.684; P=.008). Overall, 8 of 25 patients were found to have biopsy-proven urothelial carcinoma (3 in the CFRT arm and 5 in the MHRT arm; P=.27). Thus, the 8-year actuarial incidence of macroscopic hematuria (after censoring urothelial cancer–related episodes) was 4.1% and 18.2% after CFRT and MHRT, respectively (hazard ratio 4.961, 95% CI 1.426-17.263; P=.012). The results were confirmed by multivariate analysis after accounting for several patient-, treatment-, and tumor-related covariates. Conclusions: MHRT was associated with a statistically significant increased risk of macroscopic hematuria compared with CFRT.

  17. Single- versus multi-phase acquisition protocol for prospective-triggered sequential dual-source CT coronary angiography: comparison of image quality and radiation dose.

    Science.gov (United States)

    Huang, Wei; Xu, Yiming; Lu, Daoyan; Shi, Yuzhen; Lu, Guangming

    2015-01-01

    To investigate image quality and radiation dose of single- versus multi-phase acquisition protocol for prospective-triggered sequential dual-source computed tomography (CT) coronary angiography. A total of 140 patients were randomly assigned to single- or multi-phase group. Image quality and radiation dose were compared. No significant difference was found in image quality between the two groups. Effective dose of single-phase group was 21.6% lower than that of multi-phase group (Psource CT coronary angiography using single-phase protocol can reduce radiation dose without sacrifice of image quality in diastole compared with multi-phase protocol. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. Early symptoms in the prodromal phase of delirium: a prospective cohort study in elderly patients undergoing hip surgery.

    Science.gov (United States)

    de Jonghe, Jos F M; Kalisvaart, Kees J; Dijkstra, Marty; van Dis, Huib; Vreeswijk, Ralph; Kat, Martin G; Eikelenboom, Piet; van der Ploeg, Tjeerd; van Gool, Willem A

    2007-02-01

    The authors investigated prodromal delirium symptoms in elderly patients undergoing hip surgery. This was a prospective cohort study in the setting of a large medical school-affiliated general hospital in Alkmaar, The Netherlands. Participants were patients undergoing hip surgery aged 70 and older at risk for delirium. Before surgery, patients were randomized to low-dose prophylactic haloperidol treatment or placebo. Daily assessments were based on patient interviews with the Mini-Mental State Examination and Digit Span test. The Delirium Rating Scale-Revised (DRS-R-98) was used to measure early symptoms during the prodromal phase before the onset of delirium. Data of 66 patients with delirium were compared with those of 35 at-risk patients who did not develop delirium: 14 of 66 patients (21%) had delirium on the day of surgery or early the day after, 32 of 66 (48%) on the second day, 14 of 66 on the third, and six of 66 (9%) on the fourth. The average DRS-R-98 total scores on day -4 to day -1 before delirium were 1.9 for the comparison group patients and 5.0, 4.3, 5.8, and 10.7 for patients with postoperative delirium. Multivariate analysis showed that the early symptoms memory impairments, incoherence, disorientation, and underlying somatic illness predict delirium. Most elderly patients undergoing hip surgery with postoperative delirium already have early symptoms in the prodromal phase of delirium. These findings are potentially useful for screening purposes and for optimizing prevention strategies targeted at reducing the incidence of postoperative delirium.

  19. Phase change material for thermotherapy of Buruli ulcer: a prospective observational single centre proof-of-principle trial.

    Directory of Open Access Journals (Sweden)

    Thomas Junghanss

    Full Text Available BACKGROUND: Buruli ulcer (BU is an infection of the subcutaneous tissue leading to chronic necrotizing skin ulcers. The causative pathogen, Mycobacterium ulcerans, grows best at 30 degrees C-33 degrees C and not above 37 degrees C. We explored the safety, tolerability and efficacy of phase change material (PCM, a novel heat application system for thermotherapy of BU. METHODOLOGY/PRINCIPAL FINDINGS: In a prospective observational single centre proof-of-principle trial in Ayos/Cameroon, six laboratory reconfirmed patients with ulcerative Buruli lesions received 28-31 (ulcers 2 cm days of thermotherapy with the PCM sodium acetate trihydrate as heat application system. This PCM is widely used in commercial pocket heat pads, it is easy to apply, rechargeable in hot water, non-toxic and non-hazardous to the environment. All patients enrolled in the trial completed treatment. Being completely mobile during the well-tolerated heat application, acceptability of the PCM bandages was very high. In patients with smaller ulcers, wounds healed completely without further intervention. Patients with large defects had skin grafting after successful heat treatment. Heat treatment was not associated with marked increases in local inflammation or the development of ectopic lymphoid tissue. One and a half years after completion of treatment, all patients are relapse-free. CONCLUSIONS/SIGNIFICANCE: Our reusable PCM-based heat application device appears perfectly suited to treat BU in endemic countries with limited resources and infrastructure. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN88392614.

  20. Prospective phase II trial of regional hyperthermia and whole liver irradiation for numerous chemorefratory liver metastases from colerectal cancer

    Energy Technology Data Exchange (ETDEWEB)

    Yu, Jeong Il; Park, Hee Chul; Choi, Doo Ho [Dept. of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul (Korea, Republic of); and others

    2016-03-15

    A prospective phase II trial was conducted to evaluate the effectiveness and toxicity of regional hyperthermia and whole liver irradiation (WLI) for numerous chemorefractory liver metastases from colorectal cancer. Enrolled patients had numerous chemorefractory hepatic metastases from colorectal cancer. Five sessions of hyperthermia and seven fractions of 3-gray WLI were planned. Health-related quality of life (HRQoL) was determined using the Korean version of the European Organization for Research and Treatment of Cancer quality of life questionnaire C-30 and the Functional Assessment of Cancer Therapy-Hepatobiliary version 4.0. Objective and pain response was evaluated. A total of 12 patients consented to the study and the 10 who received WLI and hyperthermia were analyzed. WLI was completed as planned in nine patients and hyperthermia in eight. Pain response was partial in four patients and stable in four. Partial objective response was achieved in three patients (30.0%) and stable disease was seen in four patients at the 1-month follow-up. One patient died 1 month after treatment because of respiratory failure related to pleural metastasis progression. Other grade III or higher toxicities were detected in three patients; however, all severe toxicities were related to disease progression rather than treatment. No significant difference in HRQoL was noted at the time of assessment for patients who were available for questionnaires. Combined WLI and hyperthermia were well tolerated without severe treatment-related toxicity with a promising response from numerous chemorefractory hepatic metastases from colorectal cancer.

  1. Immunosuppressive therapy of LGL leukemia: prospective multicenter phase II study by the Eastern Cooperative Oncology Group (E5998).

    Science.gov (United States)

    Loughran, T P; Zickl, L; Olson, T L; Wang, V; Zhang, D; Rajala, H L M; Hasanali, Z; Bennett, J M; Lazarus, H M; Litzow, M R; Evens, A M; Mustjoki, S; Tallman, M S

    2015-04-01

    Failure to undergo activation-induced cell death due to global dysregulation of apoptosis is the pathogenic hallmark of large granular lymphocyte (LGL) leukemia. Consequently, immunosuppressive agents are rational choices for treatment. This first prospective trial in LGL leukemia was a multicenter, phase 2 clinical trial evaluating methotrexate (MTX) at 10 mg/m(2) orally weekly as initial therapy (step 1). Patients failing MTX were eligible for treatment with cyclophosphamide at 100 mg orally daily (step 2). The overall response in step 1 was 38% with 95% confidence interval (CI): 26 and 53%. The overall response in step 2 was 64% with 95% CI: 35 and 87%. The median overall survival for patients with anemia was 69 months with a 95% CI lower bound of 46 months and an upper bound not yet reached. The median overall survival for patients with neutropenia has not been reached 13 years from study activation. Serum biomarker studies confirmed the inflammatory milieu of LGL but were not a priori predictive of response. We identify a gene expression signature that correlates with response and may be STAT3 mutation driven. Immunosuppressive therapies have efficacy in LGL leukemia. Gene signature and mutational profiling may be an effective tool in determining whether MTX is an appropriate therapy.

  2. Synaptic signal streams generated by ex vivo neuronal networks contain non-random, complex patterns.

    Science.gov (United States)

    Lee, Sangmook; Zemianek, Jill M; Shultz, Abraham; Vo, Anh; Maron, Ben Y; Therrien, Mikaela; Courtright, Christina; Guaraldi, Mary; Yanco, Holly A; Shea, Thomas B

    2014-11-01

    Cultured embryonic neurons develop functional networks that transmit synaptic signals over multiple sequentially connected neurons as revealed by multi-electrode arrays (MEAs) embedded within the culture dish. Signal streams of ex vivo networks contain spikes and bursts of varying amplitude and duration. Despite the random interactions inherent in dissociated cultures, neurons are capable of establishing functional ex vivo networks that transmit signals among synaptically connected neurons, undergo developmental maturation, and respond to exogenous stimulation by alterations in signal patterns. These characteristics indicate that a considerable degree of organization is an inherent property of neurons. We demonstrate herein that (1) certain signal types occur more frequently than others, (2) the predominant signal types change during and following maturation, (3) signal predominance is dependent upon inhibitory activity, and (4) certain signals preferentially follow others in a non-reciprocal manner. These findings indicate that the elaboration of complex signal streams comprised of a non-random distribution of signal patterns is an emergent property of ex vivo neuronal networks. Copyright © 2014. Published by Elsevier Ltd.

  3. Non-random nectar unloading interactions between foragers and their receivers in the honeybee hive

    Science.gov (United States)

    Goyret, Joaquín; Farina, Walter M.

    2005-09-01

    Nectar acquisition in the honeybee Apis mellifera is a partitioned task in which foragers gather nectar and bring it to the hive, where nest mates unload via trophallaxis (i.e. mouth-to-mouth transfer) the collected food for further storage. Because forager mates exploit different feeding places simultaneously, this study addresses the question of whether nectar unloading interactions between foragers and hive-bees are established randomly, as it is commonly assumed. Two groups of foragers were trained to exploit a different scented food source for 5 days. We recorded their trophallaxes with hive-mates, marking the latter ones according to the forager group they were unloading. We found non-random probabilities for the occurrence of trophallaxes between experimental foragers and hive-bees, instead, we found that trophallactic interactions were more likely to involve groups of individuals which had formerly interacted orally. We propose that olfactory cues present in the transferred nectar promoted the observed bias, and we discuss this bias in the context of the organization of nectar acquisition: a partitioned task carried out in a decentralized insect society.

  4. Fluorescein-Guided Surgery for Resection of High-Grade Gliomas: A Multicentric Prospective Phase II Study (FLUOGLIO).

    Science.gov (United States)

    Acerbi, Francesco; Broggi, Morgan; Schebesch, Karl-Michael; Höhne, Julius; Cavallo, Claudio; De Laurentis, Camilla; Eoli, Marica; Anghileri, Elena; Servida, Maura; Boffano, Carlo; Pollo, Bianca; Schiariti, Marco; Visintini, Sergio; Montomoli, Cristina; Bosio, Lorenzo; La Corte, Emanuele; Broggi, Giovanni; Brawanski, Alexander; Ferroli, Paolo

    2018-01-01

    Purpose: Sodium fluorescein is a dye that, intravenously injected, selectively accumulates in high-grade glioma (HGG) tissue through a damaged blood-brain barrier. In this article, the final results of a multicentric prospective phase II trial (FLUOGLIO) on fluorescein-guided HGG resection through a dedicated filter on the surgical microscope were reported. Methods: Patients with suspected HGGs considered suitable for removal were eligible to participate in this trial. Fluorescein was intravenously injected at a dose of 5 to 10 mg/kg. The primary endpoint was the percentage of patients with histologically confirmed HGGs, without contrast-enhancing tumor at the immediate postoperative MRI. Secondary endpoints were PFS, residual tumor on postoperative MRI, overall survival, neurologic deficits, and fluorescein-related toxicity. The sensitivity and specificity of fluorescein in identifying tumor tissue were estimated by fluorescent and nonfluorescent biopsies at the tumor margin. The study was registered on the European Regulatory Authorities website (EudraCT 2011-002527-18). Results: Fifty-seven patients aged 45 to 75 years were screened for participation, and 46 were considered for primary and secondary endpoints. Mean preoperative tumor volume was 28.75 cm 3 (range, 1.3-87.8 cm 3 ). Thirty-eight patients (82.6%) underwent a complete tumor removal. Median follow-up was 11 months. PFS-6 and PFS-12 were 56.6% and 15.2%. Median survival was 12 months. No adverse reaction related to SF administration was recorded. The sensitivity and specificity of fluorescein in identifying tumor tissue were respectively 80.8% and 79.1%. Conclusions: Fluorescein-guided technique with a dedicated filter on the surgical microscope is safe and enables a high percentage of contrast-enhancing tumor in patients with HGGs. Clin Cancer Res; 24(1); 52-61. ©2017 AACR . ©2017 American Association for Cancer Research.

  5. Integrated boost IMRT with FET-PET-adapted local dose escalation in glioblastomas. Results of a prospective phase II study

    Energy Technology Data Exchange (ETDEWEB)

    Piroth, M.D.; Pinkawa, M.; Holy, R. [RWTH Aachen University Hospital (Germany). Dept. of Radiation Oncology; Forschungszentrum Juelich GmbH (DE). Juelich-Aachen Research Alliance (JARA) - Section JARA-Brain] (and others)

    2012-04-15

    Dose escalations above 60 Gy based on MRI have not led to prognostic benefits in glioblastoma patients yet. With positron emission tomography (PET) using [{sup 18}F]fluorethyl-L-tyrosine (FET), tumor coverage can be optimized with the option of regional dose escalation in the area of viable tumor tissue. In a prospective phase II study (January 2008 to December 2009), 22 patients (median age 55 years) received radiochemotherapy after surgery. The radiotherapy was performed as an MRI and FET-PET-based integrated-boost intensity-modulated radiotherapy (IMRT). The prescribed dose was 72 and 60 Gy (single dose 2.4 and 2.0 Gy, respectively) for the FET-PET- and MR-based PTV-FET{sub (72 Gy)} and PTV-MR{sub (60 Gy)}. FET-PET and MRI were performed routinely for follow-up. Quality of life and cognitive aspects were recorded by the EORTC-QLQ-C30/QLQ Brain20 and Mini-Mental Status Examination (MMSE), while the therapy-related toxicity was recorded using the CTC3.0 and RTOG scores. Median overall survival (OS) and disease-free survival (DFS) were 14.8 and 7.8 months, respectively. All local relapses were detected at least partly within the 95% dose volume of PTV-MR{sub (60 Gy)}. No relevant radiotherapy-related side effects were observed (excepted alopecia). In 2 patients, a pseudoprogression was observed in the MRI. Tumor progression could be excluded by FET-PET and was confirmed in further MRI and FET-PET imaging. No significant changes were observed in MMSE scores and in the EORTC QLQ-C30/QLQ-Brain20 questionnaires. Our dose escalation concept with a total dose of 72 Gy, based on FET-PET, did not lead to a survival benefit. Acute and late toxicity were not increased, compared with historical controls and published dose-escalation studies. (orig.)

  6. A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma

    Directory of Open Access Journals (Sweden)

    Hamid Omid

    2011-11-01

    Full Text Available Abstract Background Ipilimumab, a fully human monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4, has demonstrated an improvement in overall survival in two phase III trials of patients with advanced melanoma. The primary objective of the current trial was to prospectively explore candidate biomarkers from the tumor microenvironment for associations with clinical response to ipilimumab. Methods In this randomized, double-blind, phase II biomarker study (ClinicalTrials.gov NCT00261365, 82 pretreated or treatment-naïve patients with unresectable stage III/IV melanoma were induced with 3 or 10 mg/kg ipilimumab every 3 weeks for 4 doses; at Week 24, patients could receive maintenance doses every 12 weeks. Efficacy was evaluated per modified World Health Organization response criteria and safety was assessed continuously. Candidate biomarkers were evaluated in tumor biopsies collected pretreatment and 24 to 72 hours after the second ipilimumab dose. Polymorphisms in immune-related genes were also evaluated. Results Objective response rate, response patterns, and safety were consistent with previous trials of ipilimumab in melanoma. No associations between genetic polymorphisms and clinical activity were observed. Immunohistochemistry and histology on tumor biopsies revealed significant associations between clinical activity and high baseline expression of FoxP3 (p = 0.014 and indoleamine 2,3-dioxygenase (p = 0.012, and between clinical activity and increase in tumor-infiltrating lymphocytes (TILs between baseline and 3 weeks after start of treatment (p = 0.005. Microarray analysis of mRNA from tumor samples taken pretreatment and post-treatment demonstrated significant increases in expression of several immune-related genes, and decreases in expression of genes implicated in cancer and melanoma. Conclusions Baseline expression of immune-related tumor biomarkers and a post-treatment increase in TILs may be positively associated with

  7. Plasticity-Driven Self-Organization under Topological Constraints Accounts for Non-random Features of Cortical Synaptic Wiring.

    Science.gov (United States)

    Miner, Daniel; Triesch, Jochen

    2016-02-01

    Understanding the structure and dynamics of cortical connectivity is vital to understanding cortical function. Experimental data strongly suggest that local recurrent connectivity in the cortex is significantly non-random, exhibiting, for example, above-chance bidirectionality and an overrepresentation of certain triangular motifs. Additional evidence suggests a significant distance dependency to connectivity over a local scale of a few hundred microns, and particular patterns of synaptic turnover dynamics, including a heavy-tailed distribution of synaptic efficacies, a power law distribution of synaptic lifetimes, and a tendency for stronger synapses to be more stable over time. Understanding how many of these non-random features simultaneously arise would provide valuable insights into the development and function of the cortex. While previous work has modeled some of the individual features of local cortical wiring, there is no model that begins to comprehensively account for all of them. We present a spiking network model of a rodent Layer 5 cortical slice which, via the interactions of a few simple biologically motivated intrinsic, synaptic, and structural plasticity mechanisms, qualitatively reproduces these non-random effects when combined with simple topological constraints. Our model suggests that mechanisms of self-organization arising from a small number of plasticity rules provide a parsimonious explanation for numerous experimentally observed non-random features of recurrent cortical wiring. Interestingly, similar mechanisms have been shown to endow recurrent networks with powerful learning abilities, suggesting that these mechanism are central to understanding both structure and function of cortical synaptic wiring.

  8. No evidence for MHC class II-based non-random mating at the gametic haplotype in Atlantic salmon.

    Science.gov (United States)

    Promerová, M; Alavioon, G; Tusso, S; Burri, R; Immler, S

    2017-06-01

    Genes of the major histocompatibility complex (MHC) are a likely target of mate choice because of their role in inbreeding avoidance and potential benefits for offspring immunocompetence. Evidence for female choice for complementary MHC alleles among competing males exists both for the pre- and the postmating stages. However, it remains unclear whether the latter may involve non-random fusion of gametes depending on gametic haplotypes resulting in transmission ratio distortion or non-random sequence divergence among fused gametes. We tested whether non-random gametic fusion of MHC-II haplotypes occurs in Atlantic salmon Salmo salar. We performed in vitro fertilizations that excluded interindividual sperm competition using a split family design with large clutch sample sizes to test for a possible role of the gametic haplotype in mate choice. We sequenced two MHC-II loci in 50 embryos per clutch to assess allelic frequencies and sequence divergence. We found no evidence for transmission ratio distortion at two linked MHC-II loci, nor for non-random gamete fusion with respect to MHC-II alleles. Our findings suggest that the gametic MHC-II haplotypes play no role in gamete association in Atlantic salmon and that earlier findings of MHC-based mate choice most likely reflect choice among diploid genotypes. We discuss possible explanations for these findings and how they differ from findings in mammals.

  9. Effect of qigong training on fatigue in haemodialysis patients: A non-randomized controlled trial.

    Science.gov (United States)

    Wu, Chin-Yen; Han, Hui-Mei; Huang, Mmi-Chiung; Chen, Yu-Ming; Yu, Wen-Pin; Weng, Li-Chueh

    2014-04-01

    Fatigue is a debilitating symptom in haemodialysis patients. Qigong presents a potentially safe modality of treatment for chronic fatigue patients but has not yet been evaluated in haemodialysis patients. The aim of this study is to investigate whether qigong exercise affects fatigue in haemodialysis patients. A 6-month non-randomized control trial with six measurement periods was conducted. The qigong group was taught to practice qigong three times per week for six months. The control group received usual routine care. Main outcome measure Fatigue, as measured by the "Haemodialysis Patients Fatigue Scale". A total of 172 patients participated in this study, with 71 patients in the qigong group and 101 patients in the control group. The results indicated that all patients experienced mild to moderate fatigue. There was no difference between the qigong and control groups in fatigue at baseline. However, fatigue was lower in the qigong group than in the control group at 8 weeks (43.5 vs. 53.9), 12 weeks (44.7 vs. 53.6), 16 weeks (43.2 vs. 50.8), 20 weeks (42 vs. 50.2), and 24 weeks (41.4 vs. 48.4). The results, based on the generalized estimating equation method, showed that fatigue was significantly lower in the qigong group than in the control group (odds ratio=0.004, p=0.005). Fatigue in the qigong group showed a continuous decrease, which was maintained until the end of data collection at 24 weeks. Thus, qigong presents a potentially effective and safe method to reduce fatigue in haemodialysis patients. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. The nucleoid protein Dps binds genomic DNA of Escherichia coli in a non-random manner

    Science.gov (United States)

    Kondrashov, F. A.; Toshchakov, S. V.; Dominova, I.; Shvyreva, U. S.; Vrublevskaya, V. V.; Morenkov, O. S.; Panyukov, V. V.

    2017-01-01

    Dps is a multifunctional homododecameric protein that oxidizes Fe2+ ions accumulating them in the form of Fe2O3 within its protein cavity, interacts with DNA tightly condensing bacterial nucleoid upon starvation and performs some other functions. During the last two decades from discovery of this protein, its ferroxidase activity became rather well studied, but the mechanism of Dps interaction with DNA still remains enigmatic. The crucial role of lysine residues in the unstructured N-terminal tails led to the conventional point of view that Dps binds DNA without sequence or structural specificity. However, deletion of dps changed the profile of proteins in starved cells, SELEX screen revealed genomic regions preferentially bound in vitro and certain affinity of Dps for artificial branched molecules was detected by atomic force microscopy. Here we report a non-random distribution of Dps binding sites across the bacterial chromosome in exponentially growing cells and show their enrichment with inverted repeats prone to form secondary structures. We found that the Dps-bound regions overlap with sites occupied by other nucleoid proteins, and contain overrepresented motifs typical for their consensus sequences. Of the two types of genomic domains with extensive protein occupancy, which can be highly expressed or transcriptionally silent only those that are enriched with RNA polymerase molecules were preferentially occupied by Dps. In the dps-null mutant we, therefore, observed a differentially altered expression of several targeted genes and found suppressed transcription from the dps promoter. In most cases this can be explained by the relieved interference with Dps for nucleoid proteins exploiting sequence-specific modes of DNA binding. Thus, protecting bacterial cells from different stresses during exponential growth, Dps can modulate transcriptional integrity of the bacterial chromosome hampering RNA biosynthesis from some genes via competition with RNA polymerase

  11. Functional redundancy patterns reveal non-random assembly rules in a species-rich marine assemblage.

    Directory of Open Access Journals (Sweden)

    Nicolas Guillemot

    Full Text Available The relationship between species and the functional diversity of assemblages is fundamental in ecology because it contains key information on functional redundancy, and functionally redundant ecosystems are thought to be more resilient, resistant and stable. However, this relationship is poorly understood and undocumented for species-rich coastal marine ecosystems. Here, we used underwater visual censuses to examine the patterns of functional redundancy for one of the most diverse vertebrate assemblages, the coral reef fishes of New Caledonia, South Pacific. First, we found that the relationship between functional and species diversity displayed a non-asymptotic power-shaped curve, implying that rare functions and species mainly occur in highly diverse assemblages. Second, we showed that the distribution of species amongst possible functions was significantly different from a random distribution up to a threshold of ∼90 species/transect. Redundancy patterns for each function further revealed that some functions displayed fast rates of increase in redundancy at low species diversity, whereas others were only becoming redundant past a certain threshold. This suggested non-random assembly rules and the existence of some primordial functions that would need to be fulfilled in priority so that coral reef fish assemblages can gain a basic ecological structure. Last, we found little effect of habitat on the shape of the functional-species diversity relationship and on the redundancy of functions, although habitat is known to largely determine assemblage characteristics such as species composition, biomass, and abundance. Our study shows that low functional redundancy is characteristic of this highly diverse fish assemblage, and, therefore, that even species-rich ecosystems such as coral reefs may be vulnerable to the removal of a few keystone species.

  12. Non-random integration of the HPV genome in cervical cancer.

    Directory of Open Access Journals (Sweden)

    Martina Schmitz

    Full Text Available HPV DNA integration into the host genome is a characteristic but not an exclusive step during cervical carcinogenesis. It is still a matter of debate whether viral integration contributes to the transformation process beyond ensuring the constitutive expression of the viral oncogenes. There is mounting evidence for a non-random distribution of integration loci and the direct involvement of cellular cancer-related genes. In this study we addressed this topic by extending the existing data set by an additional 47 HPV16 and HPV18 positive cervical carcinoma. We provide supportive evidence for previously defined integration hotspots and have revealed another cluster of integration sites within the cytogenetic band 3q28. Moreover, in the vicinity of these hotspots numerous microRNAs (miRNAs are located and may be influenced by the integrated HPV DNA. By compiling our data and published reports 9 genes could be identified which were affected by HPV integration at least twice in independent tumors. In some tumors the viral-cellular fusion transcripts were even identical with respect to the viral donor and cellular acceptor sites used. However, the exact integration sites are likely to differ since none of the integration sites analysed thus far have shown more than a few nucleotides of homology between viral and host sequences. Therefore, DNA recombination involving large stretches of homology at the integration site can be ruled out. It is however intriguing that by sequence alignment several regions of the HPV16 genome were found to have highly homologous stretches of up to 50 nucleotides to the aforementioned genes and the integration hotspots. One common region of homologies with cellular sequences is between the viral gene E5 and L2 (nucleotides positions 4100 to 4240. We speculate that this and other regions of homology are involved in the integration process. Our observations suggest that targeted disruption, possibly also of critical cellular

  13. Acupuncture for moderate to severe allergic rhinitis: A non-randomized controlled trial.

    Science.gov (United States)

    Chen, Yi-Dan; Jin, Xiao-Qing; Yu, Mai-Hong; Fang, Ying; Huang, Li-Qin

    2016-07-01

    To evaluate the effect and safety of acupuncture therapy on patients with moderate to severe allergic rhinitis. A non-randomized controlled design was used to compare between the acupuncture group and the medication group. The acupuncture group received 8-week acupuncture therapy, and the medication group received budesonide nasal spray with cetirizine tablets for 8 weeks. The clinical symptoms and signs were analyzed before treatment, at 4 and 8 weeks after the start of treatment, and at 12 weeks after the end of treatment. Furthermore, the clinical efficacy and safety indicators were compared between the two groups. A total of 76 participants consisting of 38 in each of the two groups were enrolled. The scores of each clinical symptom and sign, including sneezing, runny nose, stuffy nose, nasal itching, and turbinate edema, and the total scores decreased over time in both groups (all P0.05). There was no statistically significant difference in the effective rates of the acupuncture group at 4 and 8 weeks after the start of treatment as well as at 12-week follow-up compared with those of the medication group (83.3% vs. 91.2%, and 94.4 % vs. 85.3%; and 80.6 % vs. 82.4%, all P>0.05). Experimental items including blood routine, urine routine, aspartate transaminase, alanine aminotransferase, urea nitrogen and creatinine were all in the normal reference ranges during the treatment in the acupuncture group. Acupuncture therapy has a comparable effect to the medication treatment on patients with moderate to severe allergic rhinitis, and it is safe with no severe adverse effects.

  14. Non-random correlation structures and dimensionality reduction in multivariate climate data

    Science.gov (United States)

    Vejmelka, Martin; Pokorná, Lucie; Hlinka, Jaroslav; Hartman, David; Jajcay, Nikola; Paluš, Milan

    2015-05-01

    It is well established that the global climate is a complex phenomenon with dynamics driven by the interaction of a multitude of identifiable but intertwined subsystems. The identification, at some level, of these subsystems is an important step towards understanding climate dynamics. We present a method to determine the number of principal components representing non-random correlation structures in climate data, or components that cannot be generated by a surrogate model of independent stochastic processes replicating the auto-correlation structure of each time series. The purpose of the method is to automatically reduce the dimensionality of large climate datasets into spatially localised components suitable for further interpretation or, for example, for use as nodes in a complex network analysis of large-scale climate dynamics. We apply the method to two 2.5° resolution NCEP/NCAR reanalysis global datasets of monthly means: the sea level pressure (SLP) and the surface air temperature (SAT), and extract 60 components explaining 87 % variance and 68 components explaining 72 % variance, respectively. The obtained components are in agreement with previous results in that they recover many well-known climate modes previously identified using other approaches including regionally constrained principal component analysis. Selected SLP components are discussed in more detail with respect to their correlation with important climate indices and their relationship to other SLP and SAT components. Finally, we consider a subset of the obtained components that have not yet been explicitly identified by other authors but seem plausible in the context of regional climate observations discussed in literature.

  15. Intrauterine synechiae after myomectomy; laparotomy versus laparoscopy: Non-randomized interventional trial

    Science.gov (United States)

    Asgari, Zahra; Hafizi, Leili; Hosseini, Rayhaneh; Javaheri, Atiyeh; Rastad, Hathis

    2015-01-01

    Background: Leiomyomata is the most frequent gynecological neoplasm. One of the major complications of myomectomy is intrauterine adhesion (synechiae). Objective: To evaluate and compare the rate and severity of synechiae formation after myomectomy by laparotomy and laparoscopy. Materials and Methods: In this non-randomized interventional trial, hysteroscopy was performed in all married fertile women who had undergone myomectomy (type 3-6 interamural and subserosal fibroids) via laparotomy and laparoscopy in Tehran’s Arash Hospital from 2010 to 2013. Three months after the operation, the occurrence rate and severity of intrauterine synechiae, and its relationship with type, number and location of myomas were investigated and compared in both groups. Results: Forty patients (19 laparoscopy and 21 laparotomy cases) were studied. Both groups were similar regarding the size, type (subserosal or intramural), number and location of myoma. The occurrence rate of synechiae in the laparoscopy and laparotomy group was 21% and 19%, respectively; showing no significant difference (p=0.99). Among all patients, no significant relationship was found between the endometrial opening (p=0.92), location (p=0.14) and type of myoma (p=0.08) with the occurrence rate of synechiae. However, a significant relationship was observed between myoma’s size (p=0.01) and the location of the largest myoma with the occurrence of synechiae (p=0.02). Conclusion: With favorable suturing methods, the outcome of intrauterine synechiae formation after myomectomy, either performed by laparotomy or laparoscopy, is similar. In all cases of myomectomy in reproductive-aged women, postoperative hysteroscopy is highly recommended to better screen intrauterine synechiae. PMID:26000007

  16. Fractionated Boron Neutron Capture Therapy in Locally Recurrent Head and Neck Cancer: A Prospective Phase I/II Trial.

    Science.gov (United States)

    Wang, Ling-Wei; Chen, Yi-Wei; Ho, Ching-Yin; Hsueh Liu, Yen-Wan; Chou, Fong-In; Liu, Yuan-Hao; Liu, Hong-Ming; Peir, Jinn-Jer; Jiang, Shiang-Huei; Chang, Chi-Wei; Liu, Ching-Sheng; Lin, Ko-Han; Wang, Shyh-Jen; Chu, Pen-Yuan; Lo, Wen-Liang; Kao, Shou-Yen; Yen, Sang-Hue

    2016-05-01

    To investigate the efficacy and safety of fractionated boron neutron capture therapy (BNCT) for recurrent head and neck (H&N) cancer after photon radiation therapy. In this prospective phase 1/2 trial, 2-fraction BNCT with intravenous L-boronophenylalanine (L-BPA, 400 mg/kg) was administered at a 28-day interval. Before each fraction, fluorine-18-labeled-BPA-positron emission tomography was conducted to determine the tumor/normal tissue ratio of an individual tumor. The prescription dose (D80) of 20 Gy-Eq per fraction was selected to cover 80% of the gross tumor volume by using a dose volume histogram, while minimizing the volume of oral mucosa receiving >10 Gy-Eq. Tumor responses and adverse effects were assessed using the Response Evaluation Criteria in Solid Tumors v1.1 and the Common Terminology Criteria for Adverse Events v3.0, respectively. Seventeen patients with a previous cumulative radiation dose of 63-165 Gy were enrolled. All but 2 participants received 2 fractions of BNCT. The median tumor/normal tissue ratio was 3.4 for the first fraction and 2.5 for the second, whereas the median D80 for the first and second fraction was 19.8 and 14.6 Gy-Eq, respectively. After a median follow-up period of 19.7 months (range, 5.2-52 mo), 6 participants exhibited a complete response and 6 exhibited a partial response. Regarding acute toxicity, 5 participants showed grade 3 mucositis and 1 participant showed grade 4 laryngeal edema and carotid hemorrhage. Regarding late toxicity, 2 participants exhibited grade 3 cranial neuropathy. Four of six participants (67%) receiving total D80 > 40 Gy-Eq had a complete response. Two-year overall survival was 47%. Two-year locoregional control was 28%. Our results suggested that 2-fraction BNCT with adaptive dose prescription was effective and safe in locally recurrent H&N cancer. Modifications to our protocol may yield more satisfactory results in the future. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. Changes in ceftriaxone pharmacokinetics/pharmacodynamics during the early phase of sepsis: a prospective, experimental study in the rat.

    Science.gov (United States)

    Selmi, Valentina; Loriga, Beatrice; Vitali, Luca; Carlucci, Martina; Di Filippo, Alessandro; Carta, Giulio; Sgambati, Eleonora; Tofani, Lorenzo; De Gaudio, Angelo Raffaele; Novelli, Andrea; Adembri, Chiara

    2016-11-15

    Sepsis is characterized by the loss of the perm-selectivity properties of the glomerular filtration barrier (GFB) with consequent albuminuria. We examined whether the pharmacokinetics-pharmacodynamics (PK/PD) of ceftriaxone (CTX), an extensively protein-bound 3rd generation cephalosporin, is altered during early sepsis and whether an increase in urinary loss of bound-CTX, due to GFB alteration, can occur in this condition. A prospective, experimental, randomized study was carried out in adult male Sprague-Dawley rats. Sepsis was induced by cecal ligation and puncture (CLP). Rats were divided into two groups: Sham-operated and CLP. CTX (100 mg i.p., equivalent to 1 g dose in humans) was administered in order to measure plasma and lung CTX concentrations at several time-points: baseline and 1, 2, 4 and 6 h after administration. CTX was measured by High Performance Liquid Chromatography (HPLC). The morphological status of the sialic components of the GFB barrier was assessed by lectin histo-chemistry. Monte Carlo simulation was performed to calculate the probability of target attainment (PTA >90%) for 80 and 100% of T free  > minimum inhibitory concentration (MIC) for 80 and 100% of dosing interval. After CLP, sepsis developed in rats as documented by the growth of polymicrobial flora in the peritoneal fluid (≤1 × 10 1 CFU in sham rats vs 5 × 10 4 -1 × 10 5  CFU in CLP rats). CTX plasma concentrations were higher in CLP than in sham rats at 2 and 4 h after administration (difference at 2 h was 47.3, p = 0.012; difference at 4 h was 24.94, p = 0.004), while lung penetration tended to be lower. An increased urinary elimination of protein-bound CTX occurred (553 ± 689 vs 149 ± 128 mg/L, p  90% for 100% of the dosing interval was reached neither for sham nor CLP rats using MIC = 1 mg/L, the clinical breakpoint for Enterobacteriacee. Sepsis causes changes in the PK of CTX and an alteration in the sialic components of the GFB, with

  18. Changes in ceftriaxone pharmacokinetics/pharmacodynamics during the early phase of sepsis: a prospective, experimental study in the rat

    Directory of Open Access Journals (Sweden)

    Valentina Selmi

    2016-11-01

    Full Text Available Abstract Background Sepsis is characterized by the loss of the perm-selectivity properties of the glomerular filtration barrier (GFB with consequent albuminuria. We examined whether the pharmacokinetics–pharmacodynamics (PK/PD of ceftriaxone (CTX, an extensively protein-bound 3rd generation cephalosporin, is altered during early sepsis and whether an increase in urinary loss of bound-CTX, due to GFB alteration, can occur in this condition. Methods A prospective, experimental, randomized study was carried out in adult male Sprague–Dawley rats. Sepsis was induced by cecal ligation and puncture (CLP. Rats were divided into two groups: Sham-operated and CLP. CTX (100 mg i.p., equivalent to 1 g dose in humans was administered in order to measure plasma and lung CTX concentrations at several time-points: baseline and 1, 2, 4 and 6 h after administration. CTX was measured by High Performance Liquid Chromatography (HPLC. The morphological status of the sialic components of the GFB barrier was assessed by lectin histo-chemistry. Monte Carlo simulation was performed to calculate the probability of target attainment (PTA >90% for 80 and 100% of Tfree > minimum inhibitory concentration (MIC for 80 and 100% of dosing interval. Measurements and main results After CLP, sepsis developed in rats as documented by the growth of polymicrobial flora in the peritoneal fluid (≤1 × 101 CFU in sham rats vs 5 × 104–1 × 105 CFU in CLP rats. CTX plasma concentrations were higher in CLP than in sham rats at 2 and 4 h after administration (difference at 2 h was 47.3, p = 0.012; difference at 4 h was 24.94, p = 0.004, while lung penetration tended to be lower. An increased urinary elimination of protein-bound CTX occurred (553 ± 689 vs 149 ± 128 mg/L, p  90% for 100% of the dosing interval was reached neither for sham nor CLP rats using MIC = 1 mg/L, the clinical breakpoint for Enterobacteriacee. Conclusions Sepsis causes changes in

  19. TARGIT-E(lderly)—Prospective phase II study of intraoperative radiotherapy (IORT) in elderly patients with small breast cancer

    International Nuclear Information System (INIS)

    Neumaier, Christian; Elena, Sperk; Grit, Welzel; Yasser, Abo-Madyan; Uta, Kraus-Tiefenbacher; Anke, Keller; Axel, Gerhardt; Marc, Sütterlin; Frederik, Wenz

    2012-01-01

    Patients ≥ 70 years with small, low-risk breast cancer who are operated but not irradiated how local relapse rates around 4% after 4 years. With adjuvant whole breast radiotherapy (WBRT) the local relapse rate drops to 1% after 4 years under Tamoxifen. It has been demonstrated that the efficacy of radiotherapy of the tumor bed only in a selected group can be non-inferior to WBRT. This prospective, multicentric single arm phase II study is based on the protocol of the international TARGIT-A study. The TARGIT-E study should confirm the efficacy of a single dose of intraoperative radiotherapy (IORT) in a well selected group of elderly patients with small breast cancer and absence of risk factors. Patients will receive IORT (20 Gy with Intrabeam system/Carl Zeiss) during breast conserving surgery. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines. Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral in breast relapse, cancer-specific and overall survival and contralateral breast cancer as well as documentation of quality of life and cosmetic outcome. The expected local relapse rates are 0.5/1/1.5% after 2.5/5/7.5 years, respectively. Discontinuation of the trial is scheduled if rates of local relapse rates rise to 3/4/6% after 2.5/5/7.5 years. Power calculations result in 540 patients with a calculated dropout rate of 20% and loss to follow-up of 20%, an alpha of 0.01 and a beta 0.05. There will be a pre- and a post-pathology stratum (n = 270 each). It is a pragmatic trial in which each participating centre has the option to modify entry criteria and criteria for WBRT according to this core protocol after consultation with the steering committee and local ethics committee (e.g. size, free margins). Only centers with access to the Intrabeam system (Carl Zeiss) can recruit patients into the trial. Its aim is to confirm the efficacy and toxicity of

  20. Cortical atrophy patterns in multiple sclerosis are non-random and clinically relevant.

    Science.gov (United States)

    Steenwijk, Martijn D; Geurts, Jeroen J G; Daams, Marita; Tijms, Betty M; Wink, Alle Meije; Balk, Lisanne J; Tewarie, Prejaas K; Uitdehaag, Bernard M J; Barkhof, Frederik; Vrenken, Hugo; Pouwels, Petra J W

    2016-01-01

    cortical atrophy in multiple sclerosis occurs largely in a non-random manner and develops (at least partly) according to distinct anatomical patterns. In addition, these cortical atrophy patterns showed stronger associations with clinical (especially cognitive) dysfunction than global cortical atrophy. © The Author (2015). Published by Oxford University Press on behalf of the Guarantors of Brain. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  1. Determination of prospective displacement-based gate threshold for respiratory-gated radiation delivery from retrospective phase-based gate threshold selected at 4D CT simulation

    International Nuclear Information System (INIS)

    Vedam, S.; Archambault, L.; Starkschall, G.; Mohan, R.; Beddar, S.

    2007-01-01

    Four-dimensional (4D) computed tomography (CT) imaging has found increasing importance in the localization of tumor and surrounding normal structures throughout the respiratory cycle. Based on such tumor motion information, it is possible to identify the appropriate phase interval for respiratory gated treatment planning and delivery. Such a gating phase interval is determined retrospectively based on tumor motion from internal tumor displacement. However, respiratory-gated treatment is delivered prospectively based on motion determined predominantly from an external monitor. Therefore, the simulation gate threshold determined from the retrospective phase interval selected for gating at 4D CT simulation may not correspond to the delivery gate threshold that is determined from the prospective external monitor displacement at treatment delivery. The purpose of the present work is to establish a relationship between the thresholds for respiratory gating determined at CT simulation and treatment delivery, respectively. One hundred fifty external respiratory motion traces, from 90 patients, with and without audio-visual biofeedback, are analyzed. Two respiratory phase intervals, 40%-60% and 30%-70%, are chosen for respiratory gating from the 4D CT-derived tumor motion trajectory. From residual tumor displacements within each such gating phase interval, a simulation gate threshold is defined based on (a) the average and (b) the maximum respiratory displacement within the phase interval. The duty cycle for prospective gated delivery is estimated from the proportion of external monitor displacement data points within both the selected phase interval and the simulation gate threshold. The delivery gate threshold is then determined iteratively to match the above determined duty cycle. The magnitude of the difference between such gate thresholds determined at simulation and treatment delivery is quantified in each case. Phantom motion tests yielded coincidence of simulation

  2. An open-label, non-randomized comparison of venlafaxine and gabapentin as monotherapy or adjuvant therapy in the management of neuropathic pain in patients with peripheral neuropathy

    Directory of Open Access Journals (Sweden)

    William Eardley

    2010-04-01

    Full Text Available William Eardley, Cory TothDepartment of Clinical Neurosciences and the University of Calgary, Calgary, AB, CanadaAbstract: Although many therapies are used in the management of neuropathic pain (NeP due to polyneuropathy (PN, few comparison studies exist. We performed a prospective, non-randomized, unblended, efficacy comparison of the serotonin-norepinephrine reuptake inhibitor venlafaxine, as either monotherapy or adjuvant therapy, with a first-line medication for NeP, gabapentin, in patients with PN-related NeP. VAS pain scores were assessed after 3 and 6 months in intervention groups and in a cohort of patients receiving no pharmacotherapy. In a total of 223 patients, we analyzed pain quantity and quality (visual analogue scale [VAS] score, Brief Pain Inventory [BPI], quality of life and health status measures [EuroQol 5 Domains, EQ-5D], Medical Outcomes Sleep Study Scale [MOSSS], Hospital Anxiety and Depression Scale [HADS] and Short Form 36 Health Survey [SF-36] after 6 months of therapy. Significant improvements in VAS pain scores occurred for all treatment groups after 6 months. Improvements in aspects of daily life and anxiety were identified in all treatment groups. Our data suggest that monotherapy or adjuvant therapy with venlafaxine is comparable to gabapentin for NeP management. We advocate for head-to-head, randomized, double-blinded studies of current NeP therapies.Keywords: peripheral neuropathy, neuropathic pain, pharmacotherapy, venlafaxine, gabapentin

  3. Concurrent chemoradiotherapy in locally advanced carcinoma of the uterine cervix: a phase I/II prospective study

    International Nuclear Information System (INIS)

    Kang, One Chul; Choi, Eun Kyung; Chung, Weon Kuu; Kim, Jong Hoon; Chang, Hye Sook; Kim, Yong Man; Kim, Young Tak; Nam, Joo Hyun; Mok, Jung Eun; Lee, Moo Song

    1998-01-01

    Prospective, single arm. Phase I/II clinical trial was performed to assess the efficacy and toxicity of the concurrent chemotherapy and definitive radiotherapy (RT) in patients with previously untreated locally advanced carcinoma of the uterine cervix. From May 1992 to January 1997, a total of 73 patients with advanced cervical carcinoma were entered on the protocol but 5 patients were excluded in analysis because of patients' refusal of treatment. Their ages ranged from 31 to 77 years, median 58 years. The international Federation of Gynecology and Obstetrics (FIGO) stage distribution was as follows: IIB 46, IIIA 2, IIIB 15 and IVA 5. RT consisted of external beam irradiation to 4, 140-5, 040 cGy/23-28 fractions plus high dose rate intracavitary treatments to deliver a dose of 30-35 Gy to point A in 6-7 fractions. During the intracavitary treatments parametrial boost was delivered for point B dose of 60 Gy in stage IIB and 65 Gy in stage IIIB. Two cycles of concurrent 5-fluorouracil and cisplatin (FP) chemotherapy (5-fluorouracil 1,000 mg/m 2 /day continuous infusion for 4 days, day 1-4, 29-32 and cisplatin 20 mg/m 2 /dy intravenous bolus for 3 days, day 1-3, 29-31) administered starting on day 1 of 1 of RT. The median follow-up was 24 months (range 4-68+). Sixty-four patients were evaluable for survival rate in this protocol: The 5-year actuarial and disease-free survival rate were 52% and 64%, respectively. The 5-year actuarial survival for stage IIB and II+IVA patients were 58% and 36%, respectively. The 5-year disease-free survival rate for stage IIB and III+IVA patients were 71% and 46%, respectively. Of the 68 patients evaluated for patterns of failure, overall recurrence rate was 27.9% (19/68): local failure in 5.9% (4/68), distant metastasis in 10.3% (7/68) and both in 11.8% (8/68). Of the 64 patients evaluated for response at one month after the completion of treatment, the complete response rate was 78% (50/64). Concurrent chemoradiation appear to be a

  4. Early symptoms in the prodromal phase of delirium: a prospective cohort study in elderly patients undergoing hip surgery

    NARCIS (Netherlands)

    de Jonghe, Jos F. M.; Kalisvaart, Kees J.; Dijkstra, Marty; van Dis, Huib; Vreeswijk, Ralph; Kat, Martin G.; Eikelenboom, Piet; van der Ploeg, Tjeerd; van Goo, Willem A.

    2007-01-01

    OBJECTIVES: The authors investigated prodromal delirium symptoms in elderly patients undergoing hip surgery. METHODS: This was a prospective cohort study in the setting of a large medical school-affiliated general hospital in Alkmaar, The Netherlands. Participants were patients undergoing hip

  5. Effectiveness of a 'Global Postural Reeducation' program for persistent Low Back Pain: a non-randomized controlled trial

    OpenAIRE

    Bonetti, Francesca; Curti, Stefania; Mattioli, Stefano; Mugnai, Raffaele; Vanti, Carla; Violante, Francesco S; Pillastrini, Paolo

    2010-01-01

    Abstract Background The aim of this non-randomized controlled trial was to evaluate the effectiveness of a Global Postural Reeducation (GPR) program as compared to a Stabilization Exercise (SE) program in subjects with persistent low back pain (LBP) at short- and mid-term follow-up (ie. 3 and 6 months). Methods According to inclusion and exclusion criteria, 100 patients with a primary complaint of persistent LBP were enrolled in the study: 50 were allocated to the GPR group and 50 to the SE g...

  6. Microstructural descriptors and cellular automata simulation of the effects of non-random nuclei location on recrystallization in two dimensions

    Directory of Open Access Journals (Sweden)

    Paulo Rangel Rios

    2006-06-01

    Full Text Available The effect of non-random nuclei location and the efficiency of microstructural descriptors in assessing such a situation are studied. Cellular automata simulation of recrystallization in two dimensions is carried out to simulate microstrutural evolution for nuclei distribution ranging from a periodic arrangement to clusters of nuclei. The simulation results are compared in detail with microstrutural descriptors normally used to follow transformation evolution. It is shown that the contiguity is particularly relevant to detect microstructural deviations from randomness. This work focuses on recrystallization but its results are applicable to any nucleation and growth transformation.

  7. Colloidal Dancers: Designing networks of DNA-functionalized colloids for non-random walks

    Science.gov (United States)

    Gehrels, Emily W.; Rogers, W. Benjamin; Zeravcic, Zorana; Manoharan, Vinothan N.

    2014-03-01

    We present experimental developments of a system of DNA-functionalized colloidal particles with the goal of creating directed motion (`dancing') along patterned substrates in response to temperature cycling. We take advantage of toehold exchange in the design of the DNA sequences that mediate the colloidal interactions to produce broadened, flat, or even re-entrant binding and unbinding transitions between the particles and substrate. Using this new freedom of design, we devise systems where, by thermal ratcheting, we can externally control the direction of motion and sequence of steps of the colloidal dancer. In comparison to DNA-based walkers, which move autonomously and whose motion is controlled by the substrate, our colloidal dancers respond to external driving, and their motion can be controlled in situ. Our use of DNA-functionalized colloidal particles instead of pure DNA systems also enables walking on the mesoscale in contrast to the molecular length scales previously demonstrated, allowing for the future prospect of directed transport over larger distances.

  8. Network meta-analysis incorporating randomized controlled trials and non-randomized comparative cohort studies for assessing the safety and effectiveness of medical treatments: challenges and opportunities

    OpenAIRE

    Cameron, Chris; Fireman, Bruce; Hutton, Brian; Clifford, Tammy; Coyle, Doug; Wells, George; Dormuth, Colin R.; Platt, Robert; Toh, Sengwee

    2015-01-01

    Network meta-analysis is increasingly used to allow comparison of multiple treatment alternatives simultaneously, some of which may not have been compared directly in primary research studies. The majority of network meta-analyses published to date have incorporated data from randomized controlled trials (RCTs) only; however, inclusion of non-randomized studies may sometimes be considered. Non-randomized studies can complement RCTs or address some of their limitations, such as short follow-up...

  9. The acute-phase response is not predictive for the development of arthritis in seropositive arthralgia - A prospective cohort study

    NARCIS (Netherlands)

    M. Limper (Maarten); L. van de Stadt (Lotte); W.H. Bos (Wouter); M.D. de Kruif (Martijn); A. van der Spek (Ashley); G.J. Wolbink (Gertjan); D. van Schaardenburg (Dirkjan); E.C.M. van Gorp (Eric)

    2012-01-01

    textabstractObjective. To evaluate whether markers of the acute-phase response in patients presenting with arthralgia and positive anticitrullinated protein antibodies (ACPA) and/or immunoglobulin M rheumatoid factor (IgM-RF) could be predictive for the development of arthritis. Methods. In total,

  10. The Acute-phase Response Is Not Predictive for the Development of Arthritis in Seropositive Arthralgia - A Prospective Cohort Study

    NARCIS (Netherlands)

    Limper, Maarten; van de Stadt, Lotte; Bos, Wouter; de Kruif, Martijn; Spek, Arnold; Wolbink, Gertjan; van Schaardenburg, Dirkjan; van Gorp, Eric

    2012-01-01

    To evaluate whether markers of the acute-phase response in patients presenting with arthralgia and positive anticitrullinated protein antibodies (ACPA) and/or immunoglobulin M rheumatoid factor (IgM-RF) could be predictive for the development of arthritis. In total, 137 ACPA- and/or IgM-RF-positive

  11. Energy expenditure at rest and during walking in patients with chronic respiratory failure: a prospective two-phase case-control study.

    Directory of Open Access Journals (Sweden)

    Ernesto Crisafulli

    Full Text Available BACKGROUND: Measurements of Energy Expenditure (EE at rest (REE and during physical activities are increasing in interest in chronic patients. In this study we aimed at evaluating the validity/reliability of the SenseWear®Armband (SWA device in terms of REE and EE during assisted walking in Chronic Respiratory Failure (CRF patients receiving long-term oxygen therapy (LTOT. METHODOLOGY/PRINCIPAL FINDINGS: In a two-phase prospective protocol we studied 40 severe patients and 35 age-matched healthy controls. In phase-1 we determined the validity and repeatability of REE measured by SWA (REEa in comparison with standard calorimetry (REEc. In phase-2 we then assessed EE and Metabolic Equivalents-METs by SWA during the 6-minute walking test while breathing oxygen in both assisted (Aid or unassisted (No-Aid modalities. When compared with REEc, REEa was slightly lower in patients (1351±169 vs 1413±194 kcal/day respectively, p<0.05, and less repeatable than in healthy controls (0.14 and 0.43 coefficient respectively. COPD patients with CRF patients reported a significant gain with Aid as compared with No-Aid modality in terms of meters walked, perceived symptoms and EE. CONCLUSIONS/SIGNIFICANCE: SWA provides a feasible and valid method to assess the energy expenditure in CRF patients on LTOT, and it shows that aided walking results in a substantial energy saving in this population.

  12. “Cancer 2015”: A Prospective, Population-Based Cancer Cohort—Phase 1: Feasibility of Genomics-Guided Precision Medicine in the Clinic

    Directory of Open Access Journals (Sweden)

    John P. Parisot

    2015-10-01

    Full Text Available “Cancer 2015” is a longitudinal and prospective cohort. It is a phased study whose aim was to pilot recruiting 1000 patients during phase 1 to establish the feasibility of providing a population-based genomics cohort. Newly diagnosed adult patients with solid cancers, with residual tumour material for molecular genomics testing, were recruited into the cohort for the collection of a dataset containing clinical, molecular pathology, health resource use and outcomes data. 1685 patients have been recruited over almost 3 years from five hospitals. Thirty-two percent are aged between 61–70 years old, with a median age of 63 years. Diagnostic tumour samples were obtained for 90% of these patients for multiple parallel sequencing. Patients identified with somatic mutations of potentially “actionable” variants represented almost 10% of those tumours sequenced, while 42% of the cohort had no mutations identified. These genomic data were annotated with information such as cancer site, stage, morphology, treatment and patient outcomes and health resource use and cost. This cohort has delivered its main objective of establishing an upscalable genomics cohort within a clinical setting and in phase 2 aims to develop a protocol for how genomics testing can be used in real-time clinical decision-making, providing evidence on the value of precision medicine to clinical practice.

  13. Prospective phase II trial of image-guided radiotherapy in Hodgkin lymphoma: benefit of deep inspiration breath-hold.

    Science.gov (United States)

    Petersen, Peter M; Aznar, Marianne C; Berthelsen, Anne K; Loft, Annika; Schut, Deborah A; Maraldo, Maja; Josipovic, Mirjana; Klausen, Thomas L; Andersen, Flemming L; Specht, Lena

    2015-01-01

    Long-term Hodgkin lymphoma (HL) survivors have an increased risk of late cardiac morbidity and secondary lung cancer after chemotherapy and mediastinal radiotherapy. In this prospective study we investigate whether radiotherapy with deep inspiration breath-hold (DIBH) can reduce radiation doses to the lungs, heart, and cardiac structures without compromising the target dose. Twenty-two patients (14 female, 8 male), median age 30 years (18-65 years), with supra-diaphragmatic HL were enrolled and had a thoracic PET/CT with DIBH in addition to staging FDG-PET/CT in free breathing (FB) and a planning CT in both FB and DIBH. For each patient an involved-node radiotherapy plan was done for both DIBH and FB, and the doses to the lungs, heart, and female breasts were recorded prospectively. Mean doses to the heart valves and coronary arteries were recorded retrospectively. Patients were treated with the technique yielding the lowest doses to normal structures. Nineteen patients were treated with DIBH and three with FB. DIBH reduced the mean estimated lung dose by 2.0 Gy (median: 8.5 Gy vs. 7.2 Gy) (p < 0.01) and the mean heart dose by 1.4 Gy (6.0 Gy vs. 3.9 Gy) (p < 0.01) compared to FB. The lung and heart V20Gy were reduced with a median of 5.3% and 6.3%. Mean doses to the female breasts were equal with FB and DIBH. DIBH can significantly decrease the estimated mean doses to the heart and lungs without lowering the dose to the target in radiotherapy for patients with mediastinal HL.

  14. Prospects for observation of neutrino-nuclear neutral current coherent scattering with two-phase Xenon emission detector

    Science.gov (United States)

    Akimov, D. Yu; Alexandrov, I. S.; Aleshin, V. I.; Belov, V. A.; Bolozdynya, A. I.; Burenkov, A. A.; Chepurnov, A. S.; Danilov, M. V.; Derbin, A. V.; Dmitrenko, V. V.; Dolgolenko, A. G.; Efremenko, Yu V.; Etenko, A. V.; Gromov, M. B.; Gulin, M. A.; Ivakhin, S. V.; Kantserov, V. A.; Kaplin, V. A.; Karelin, A. K.; Khromov, A. V.; Kirsanov, M. A.; Klimanov, S. G.; Kobyakin, A. S.; Konovalov, A. M.; Kovalenko, A. G.; Kopeikin, V. I.; Krakhmalova, T. D.; Kuchenkov, A. V.; Kumpan, A. V.; Litvinovich, E. A.; Lukyanchenko, G. A.; Machulin, I. N.; Martemyanov, V. P.; Nurakhov, N. N.; Rudik, D. G.; Saldikov, I. S.; Skorokhatov, M. D.; Sosnovtsev, V. V.; Stekhanov, V. N.; Sukhotin, S. V.; Tarasenkov, V. G.; Tikhomirov, G. V.; Zeldovich, O. Ya

    2013-10-01

    We propose to detect and to study neutrino neutral current coherent scattering off atomic nuclei with a two-phase emission detector using liquid xenon as a working medium. Expected signals and backgrounds are calculated for two possible experimental sites: the Kalinin Nuclear Power Plant in the Russian Federation and the Spallation Neutron Source at the Oak Ridge National Laboratory in the U.S.A. Both sites have advantages as well as limitations. The experiment looks feasible at either location.

  15. Rikkunshito for Preventing Chemotherapy-Induced Nausea and Vomiting in Lung Cancer Patients: Results from 2 Prospective, Randomized Phase 2 Trials

    Directory of Open Access Journals (Sweden)

    Toshiyuki Harada

    2018-01-01

    Full Text Available The herbal medicine rikkunshito has the potential to improve chemotherapy-induced nausea and vomiting (CINV by stimulating ghrelin secretion. We aimed to evaluate the efficacy and safety of rikkunshito in preventing CINV for patients with lung cancer. Two separate prospective, randomized, phase II parallel design studies were conducted in patients with lung cancer. Fifty-eight and sixty-two patients scheduled to receive highly emetogenic chemotherapy (HEC and moderately emetogenic chemotherapy (MEC, respectively, were randomized 1:1 to receive either standard antiemetic therapy in accordance with international guidelines (S group or standard antiemetic therapy plus oral rikkunshito (R group. The primary endpoint was overall complete response (CR—that is, no emesis and rescue medication in the first 120 h post-chemotherapy. Secondary endpoints included CR in the acute (0–24 h and delayed (>24–120 h phases and safety. Fifty-seven patients (S group, 28; R group, 29 receiving HEC and sixty-two patients (S group, 30; R group, 32 receiving MEC with comparable characteristics were evaluated. The CR rates were similar across the S and R groups for the HEC study in the overall (67.9% vs. 62.1%, acute (96.4% vs. 89.6%, and delayed (67.9% vs. 62.1% phases, respectively, and for the MEC study in the overall (83.3% vs. 84.4%, acute (100% vs. 100%, and delayed (83.3% vs. 84.4% phases, respectively. No severe adverse events were observed. Although rikkunshito was well tolerated, it did not demonstrate an additional preventative effect against CINV in lung cancer patients receiving HEC or MEC.Clinical Trial Registry Information: This study is registered with the University Hospital Medical Information Network (UMIN Clinical Trial Registry1, identification numbers UMIN 000014239 and UMIN 000014240.

  16. Preoperative Accelerated Partial Breast Irradiation for Early-Stage Breast Cancer: Preliminary Results of a Prospective, Phase 2 Trial

    International Nuclear Information System (INIS)

    Nichols, Elizabeth; Kesmodel, Susan B.; Bellavance, Emily; Drogula, Cynthia; Tkaczuk, Katherine; Cohen, Randi J.; Citron, Wendla; Morgan, Michelle; Staats, Paul; Feigenberg, Steven; Regine, William F.

    2017-01-01

    Purpose: To assess the feasibility of utilizing 3-dimensional conformal accelerated partial-breast irradiation (APBI) in the preoperative setting followed by standard breast-conserving therapy. Patients and Methods: This was a prospective trial testing the feasibility of preoperative APBI followed by lumpectomy for patients with early-stage invasive ductal breast cancer. Eligible patients had T1-T2 (<3 cm), N0 tumors. Patients received 38.5 Gy in 3.85-Gy fractions delivered twice daily. Surgery was performed >21 days after radiation therapy. Adjuvant therapy was given as per standard of care. Results: Twenty-seven patients completed treatment. With a median follow-up of 3.6 years (range, 0.5-5 years), there have been no local or regional failures. A complete pathologic response according to hematoxylin and eosin stains was seen in 4 patients (15%). There were 4 grade 3 seromas. Patient-reported cosmetic outcome was rated as good to excellent in 79% of patients after treatment. Conclusions: Preoperative 3-dimensional conformal radiation therapy−APBI is feasible and well tolerated in select patients with early-stage breast cancer, with no reported local recurrences and good to excellent cosmetic results. The pathologic response rates associated with this nonablative APBI dose regimen are particularly encouraging and support further exploration of this paradigm.

  17. Preoperative Accelerated Partial Breast Irradiation for Early-Stage Breast Cancer: Preliminary Results of a Prospective, Phase 2 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Nichols, Elizabeth, E-mail: Enichols1@umm.edu [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland (United States); Kesmodel, Susan B.; Bellavance, Emily; Drogula, Cynthia [Department of Surgical Oncology, University of Maryland School of Medicine, Baltimore, Maryland (United States); Tkaczuk, Katherine [Department of Medical Oncology, University of Maryland School of Medicine, Baltimore, Maryland (United States); Cohen, Randi J.; Citron, Wendla; Morgan, Michelle [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland (United States); Staats, Paul [Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland (United States); Feigenberg, Steven; Regine, William F. [Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Maryland (United States)

    2017-03-15

    Purpose: To assess the feasibility of utilizing 3-dimensional conformal accelerated partial-breast irradiation (APBI) in the preoperative setting followed by standard breast-conserving therapy. Patients and Methods: This was a prospective trial testing the feasibility of preoperative APBI followed by lumpectomy for patients with early-stage invasive ductal breast cancer. Eligible patients had T1-T2 (<3 cm), N0 tumors. Patients received 38.5 Gy in 3.85-Gy fractions delivered twice daily. Surgery was performed >21 days after radiation therapy. Adjuvant therapy was given as per standard of care. Results: Twenty-seven patients completed treatment. With a median follow-up of 3.6 years (range, 0.5-5 years), there have been no local or regional failures. A complete pathologic response according to hematoxylin and eosin stains was seen in 4 patients (15%). There were 4 grade 3 seromas. Patient-reported cosmetic outcome was rated as good to excellent in 79% of patients after treatment. Conclusions: Preoperative 3-dimensional conformal radiation therapy−APBI is feasible and well tolerated in select patients with early-stage breast cancer, with no reported local recurrences and good to excellent cosmetic results. The pathologic response rates associated with this nonablative APBI dose regimen are particularly encouraging and support further exploration of this paradigm.

  18. Three-phase bone scan and indium white blood cell scintigraphy following porous coated hip arthroplasty: A prospective study of the prosthetic tip

    International Nuclear Information System (INIS)

    Oswald, S.G.; Van Nostrand, D.; Savory, C.G.; Callaghan, J.J.

    1989-01-01

    Although few reports address the use of three-phase bone scanning (TPBS) and 111 In-labeled white blood cell (In-WBC) scintigraphy in hip arthroplasty utilizing a porous coated prosthesis, the literature suggests that scintigraphic patterns in the uncomplicated patient may differ from that seen in the cemented prosthesis. In an attempt to determine the scintigraphic natural history, 25 uncomplicated porous coated hip arthroplasties in 21 patients were prospectively studied with serial TPBS and In-WBC at approximately 7 days, and at 3, 6, 12, 18, and 24 mo postoperatively. This report deals with findings related to the prosthetic tip. Only one of 136 flow studies were abnormal and only two of 136 blood-pool images demonstrated focally increased activity. All 25 prostheses (120 of 143 scans) demonstrated increased uptake on the bone phase images. The area about the tip was divided into three segments; increased uptake at 24 mo was noted in the medial, distal, and lateral segments in 16%, 72%, and 56% of prostheses, respectively. Twenty of 25 prostheses (82 of 142 scans) showed uptake on In-WBC scintigraphy, being noted in 48% of prostheses at 24 mo. We conclude that scintigraphic patterns in the uncomplicated patient with a porous coated prosthesis appear to differ from patterns described in cemented prostheses

  19. The acetabulum: A prospective study of three-phase bone and indium white blood cell scintigraphy following porous-coated hip arthroplasty

    International Nuclear Information System (INIS)

    Oswald, S.G.; Van Nostrand, D.; Savory, C.G.; Anderson, J.H.; Callaghan, J.J.

    1990-01-01

    Although few studies address the use of three-phase bone scanning (TPBS) and indium-111-labeled white blood cell scintigraphy ( 111 In-WBC) in hip arthroplasty utilizing a porous-coated prosthesis, the literature suggests that scintigraphic patterns in the uncomplicated patient may differ from that seen with the cemented prosthesis. In an attempt to determine the scintigraphic natural history, 25 uncomplicated porous-coated hip arthroplasties in 21 patients were prospectively studied with serial TPBS and 111I n-WBC at approximately 7 days, and 3, 6, 12, 18, and 24 mo postoperatively. This report deals with findings related to the acetabulum. All 25 prostheses (144 of 144 scans) demonstrated increased uptake on the bone-phase images. Although this activity decreased with time, 76% had persistent uptake at 24 mo. Twenty-three of 25 prostheses (126 of 140 scans) showed increased uptake on 111 In-WBC scintigraphy, invariably decreasing with time, but with 37% having significant uptake at 24 mo. Scintigraphic patterns in the uncomplicated porous-coated hip arthroplasty patient appear to differ from patterns described in cemented prostheses

  20. Impact of more intensive written information in patients having radical radiation therapy: Results of a prospective randomized phase III trial

    International Nuclear Information System (INIS)

    Zissiadis, Yvonne; Harper, Emily; Kearney, Elizabeth

    2010-01-01

    Background and purpose: A diagnosis of malignancy and its treatment is a very stressful time for patients and their families. This study was conducted to determine the impact of more intensive written information on patients' anxiety levels. The secondary aim was to determine the impact of this information on patients' satisfaction levels. Materials and methods: This prospective randomized trial consisted of patients with a pathological diagnosis of cancer having radical radiotherapy (RT). Patients were randomized to receive the more intensive information (including written information and a telephone call from the research nurse) or not to receive the more intensive information at the time of their initial consultation with the radiation oncologist. Study questionnaires measuring anxiety (STAI form) were completed prior to their first consultation (baseline) at the time of simulation (pre-RT) and at the completion of radiotherapy. A second questionnaire assessing satisfaction with the information given (ISQ) was completed at the time of simulation prior to commencing RT. Results: One hundred and ninety-four patients were enrolled in the study. The mean age of the patients was 58.5 years and 70% of patients were female. Breast cancer (67%) was the commonest cancer. One hundred and two patients were randomized to receive the intensive information package and 92 patients received the standard consultation. There was no significant difference in mean State or Trait anxiety scores between any of the time intervals and no difference between the two information groups. There was no significant difference between the groups with regard to mean satisfaction scores with the overall information given, nor with any individual question. The satisfaction scores with lifestyle information given were lower than those for any other type of information in both randomization arms. Conclusion: More intensive information did not significantly change patients' anxiety scores or

  1. Prospective Phase I-II Trial of Helical Tomotherapy With or Without Chemotherapy for Postoperative Cervical Cancer Patients

    International Nuclear Information System (INIS)

    Schwarz, Julie K.; Wahab, Sasa; Grigsby, Perry W.

    2011-01-01

    Purpose: To investigate, in a prospective trial, the acute and chronic toxicity of patients with cervical cancer treated with surgery and postoperative intensity-modulated radiotherapy (RT) delivered using helical tomotherapy, with or without the administration of concurrent chemotherapy. Patients and Methods: A total of 24 evaluable patients entered the study between March 2006 and August 2009. The indications for postoperative RT were tumor size, lymphovascular space invasion, and the depth of cervical stromal invasion in 15 patients; 9 patients underwent postoperative RT because of surgically positive lymph nodes. All patients underwent pelvic RT delivered with helical tomotherapy and intracavitary high-dose-rate brachytherapy. Treatment consisted of concurrent weekly platinum in 17, sequential carboplatin/Taxol in 1, and RT alone in 6. The patients were monitored for acute and chronic toxicity using the Common Toxicity Criteria, version 3.0. Results: The median follow-up was 24 months (range, 4–49). At the last follow-up visit, 23 patients were alive and disease free. Of the 24 patients, 12 (50%) experienced acute Grade 3 gastrointestinal toxicity (anorexia in 5, diarrhea in 4, and nausea in 3). One patient developed acute Grade 4 genitourinary toxicity (vesicovaginal fistula). For patients treated with concurrent chemotherapy, the incidence of acute Grade 3 and 4 hematologic toxicity was 71% and 24%, respectively. For patients treated without concurrent chemotherapy, the incidence of acute Grade 3 and 4 hematologic toxicity was 29% and 14%, respectively. Two long-term toxicities occurred (vesicovaginal fistula at 25 months and small bowel obstruction at 30 months). The overall and progression-free survival rate at 3 years for all patients was 100% and 89%, respectively. Conclusion: The results of our study have shown that postoperative external RT for cervical cancer delivered with helical tomotherapy and high-dose-rate brachytherapy and with or without

  2. Prospective Phase I-II Trial of Helical Tomotherapy With or Without Chemotherapy for Postoperative Cervical Cancer Patients

    Energy Technology Data Exchange (ETDEWEB)

    Schwarz, Julie K., E-mail: jschwarz@radonc.wustl.edu [Department of Radiation Oncology, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO (United States); Department of Cell Biology and Physiology, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO (United States); Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO (United States); Wahab, Sasa [Cobb Center for Radiation Oncology Center, Austell, GA (United States); Grigsby, Perry W. [Department of Radiation Oncology, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO (United States); Alvin J. Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO (United States); Division of Nuclear Medicine, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO (United States); Department of Obstetrics and Gynecology, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, MO (United States)

    2011-12-01

    Purpose: To investigate, in a prospective trial, the acute and chronic toxicity of patients with cervical cancer treated with surgery and postoperative intensity-modulated radiotherapy (RT) delivered using helical tomotherapy, with or without the administration of concurrent chemotherapy. Patients and Methods: A total of 24 evaluable patients entered the study between March 2006 and August 2009. The indications for postoperative RT were tumor size, lymphovascular space invasion, and the depth of cervical stromal invasion in 15 patients; 9 patients underwent postoperative RT because of surgically positive lymph nodes. All patients underwent pelvic RT delivered with helical tomotherapy and intracavitary high-dose-rate brachytherapy. Treatment consisted of concurrent weekly platinum in 17, sequential carboplatin/Taxol in 1, and RT alone in 6. The patients were monitored for acute and chronic toxicity using the Common Toxicity Criteria, version 3.0. Results: The median follow-up was 24 months (range, 4-49). At the last follow-up visit, 23 patients were alive and disease free. Of the 24 patients, 12 (50%) experienced acute Grade 3 gastrointestinal toxicity (anorexia in 5, diarrhea in 4, and nausea in 3). One patient developed acute Grade 4 genitourinary toxicity (vesicovaginal fistula). For patients treated with concurrent chemotherapy, the incidence of acute Grade 3 and 4 hematologic toxicity was 71% and 24%, respectively. For patients treated without concurrent chemotherapy, the incidence of acute Grade 3 and 4 hematologic toxicity was 29% and 14%, respectively. Two long-term toxicities occurred (vesicovaginal fistula at 25 months and small bowel obstruction at 30 months). The overall and progression-free survival rate at 3 years for all patients was 100% and 89%, respectively. Conclusion: The results of our study have shown that postoperative external RT for cervical cancer delivered with helical tomotherapy and high-dose-rate brachytherapy and with or without

  3. Irreversible Electroporation (IRE) Fails to Demonstrate Efficacy in a Prospective Multicenter Phase II Trial on Lung Malignancies: The ALICE Trial

    Energy Technology Data Exchange (ETDEWEB)

    Ricke, Jens, E-mail: jens.ricke@med.ovgu.de; Jürgens, Julian H. W., E-mail: julian.juergens@med.ovgu.de [University of Magdeburg, Department of Radiology and Nuclear Medicine (Germany); Deschamps, Frederic; Tselikas, Lambros [Institut de Cancérologie Gustave Roussy, Department of Image Guided Therapy (France); Uhde, Katja; Kosiek, Ortrud [University of Magdeburg, Department of Radiology and Nuclear Medicine (Germany); Baere, Thierry De [Institut de Cancérologie Gustave Roussy, Department of Image Guided Therapy (France)

    2015-04-15

    PurposeTo assess safety and efficacy of irreversible electroporation (IRE) of lung malignancies.Materials and MethodsPatients with primary and secondary lung malignancies and preserved lung function were included in this prospective single arm trial. Primary and secondary endpoints were safety and efficacy. Recruitment goal was 36 subjects in 2 centers. Patients underwent IRE under general anesthesia with probe placement performed in Fluoroscopy-CT. The IRE system employed was NanoKnife{sup ®} (Angiodynamics). System settings for the ablation procedure followed the manufacturer’s recommendations. The Mann–Whitney U test was used to evaluate the correlation of nine technical parameters with local tumor control. Median follow up was 12 months.ResultsThe expected efficacy was not met at interim analysis and the trial was stopped prematurely after inclusion of 23 patients (13/10 between both centers). The dominant tumor entity was colorectal (n = 13). The median tumor diameter was 16 mm (8–27 mm). Pneumothoraces were observed in 11 of 23 patients with chest tubes required in 8 (35 %). Frequently observed alveolar hemorrhage never led to significant hemoptysis. 14/23 showed progressive disease (61 %). Stable disease was found in 1 (4 %), partial remission in 1 (4 %) and complete remission in 7 (30 %) patients. The relative increase of the current during ablation was significantly higher in the group treated successfully as compared to the group presenting local recurrence (p < 0.05). Needle tract seeding was found in three cases (13 %).ConclusionsIRE is not effective for the treatment of lung malignancies. We hypothesize that the energy deposition with current IRE probes is highly sensitive to air exposure.

  4. Prospective association of TV viewing with acute phase reactants and coagulation markers: English Longitudinal Study of Ageing.

    Science.gov (United States)

    Hamer, Mark; Smith, Lee; Stamatakis, Emmanuel

    2015-04-01

    Inflammatory processes are putative mechanisms underlying the detrimental health effects of sedentary behaviour but no long-term prospective data are available. We examined the longitudinal association between TV viewing, physical activity and inflammatory markers over a 4-year follow-up period. Participants were 3612 men and women (mean age 64.1 ± 8.2 years) from the English Longitudinal Study of Ageing. Self-reported daily TV viewing was measured at baseline and 2 years follow up. Inflammatory markers (serum high-sensitivity C-reactive protein [CRP], white blood cell count [WBC], and fibrinogen) were measured at baseline (2008/09) and 4 years follow-up (2012/13). On average, participants viewed TV for 5.1 ± 4.0 h/d, and there was an increase of 1.9 h/wk TV viewing over 2 years. In linear models adjusted for covariates including physical activity, TV viewing was not associated with logeCRP at follow-up (B = 0.004, 95% CI, -0.001, 0.009, p = 0.09) but was associated with WBC (B = 0.018, 95% CI, 0.005, 0.031, p = 0.006), and fibrinogen (B = 0.004, 95% CI, 0.00, 0.008, p = 0.035). In contrast, physical activity was inversely associated with CRP (p = 0.047) and WBC (p = 0.026), but not fibrinogen (p = 0.22). An increase in TV viewing (of at least 1 h/d) was associated with higher concentrations of CRP (p = 0.015) and WBC (p = 0.05) at follow up after adjustment for covariates and baseline TV viewing. Physical activity and sedentary behaviour have contrasting associations with markers of low grade inflammation over 4 years of follow-up. These behaviours may be important in influencing the pro-inflammatory state seen with ageing. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  5. [Changes in quality of life and work function during phase prophylactic lamotrigine treatment in bipolar patients: 6 month, prospective, observational study].

    Science.gov (United States)

    Gonda, Xenia; Kalman, Janos; Dome, Peter; Rihmer, Zoltan

    2016-03-01

    Bipolar disorder is a lifelong illness requiring lifelong pharmacotherapy. Therefore besides symptomatic remission, achievement of full work-related functioning and restoration of quality of life is a priority during successful treatment. The present prospective, observational, non-intervention study focused on investigating the effect of lamotrigine therapy on the quality of life and work-related function of bipolar patients in outpatient care. 969 bipolar or schizoaffective outpatients participated in the study who previously did not receive lamotrigine therapy. Our present phase-prophylactic study was a prospective, observational, non-intervention study with a six-month follow-up. Evaluations took place at baseline and at months 1, 2, 3 and 6. Patients were followed with a Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I). Changes in work-related function was evaluated using Social Adjustment Scale (SAS), while quality of life was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale. SAS scoreds showed a consistent decrease in the overall sample and in all CGI-S initial groups reflecting the improvement of work-related function during the six months of the follow-up. Q-LES-Q values in the whole sample and in all initial CGI-S groups showed a steady increase indicating a continuous increase in quality of life during the study. Our results indicate that during long-term prophylactic lamotrigine therapy the work function and quality of life of bipolar patients shows a significant improvement, therefore lamotrigine provides a possibility for full functional remission and restoration of quality of life.

  6. A non-randomized comparison of gemcitabine-based chemoradiation with or without induction chemotherapy for locally advanced squamous cell carcinoma of the head and neck

    International Nuclear Information System (INIS)

    Specenier, Pol M; Weyler, Joost; Van Laer, Carl; Weyngaert, Danielle Van den; Brande, Jan Van den; Huizing, Manon T; Altintas, Sevilay; Vermorken, Jan B

    2009-01-01

    Concomitant chemotherapy and radiotherapy (chemoradiation; CRT) is the standard treatment for locoregionally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). CRT improves local control and overall survival (OS) when compared to radiotherapy (RT) alone. Induction chemotherapy (IC) reduces the risk of distant metastases (DM) and improves OS by 5% with the use of cisplatin/infusional 5 fluorouracil (PF) in meta-analysis. Adding a taxane to PF in the IC regimen confers a better outcome. Sequential treatment (ST) of IC followed by CRT is therefore under active investigation in multiple phase III trials. We compared the outcome of two cohorts of patients (pts) with LA-SCCHN treated at our institution with CRT (n = 27) or ST (n = 31), respectively. CRT consisted of GEM 100 mg/m 2 weekly + conventional RT (70 Gy); ST consisted of the same CRT preceded by platinum-based IC. Response to IC: complete 8 (26%), partial 20 (65%), stable 1, progressive 1, not evaluable 1. Median follow up of the surviving pts: for CRT 73 months, for ST 51 months. Median time to distant metastasis (TDM) was for CRT 23.6 months, for ST not reached. Median OS was for CRT 20.2 months, for ST 40.2 months. Cox regression analysis, taking into account age, T and N stage and tumor site, showed a hazard ratio with ST of 1.190 for time to locoregional failure (p = 0.712), 0.162 for TDM (p = 0.002), and 0.441 for overall survival (OS) (p = 0.026). TDM and OS were found significantly longer in the ST cohort without a reduced locoregional control. Notwithstanding the limitations of a non-randomized single-center comparison, the results are in line with very preliminary data of randomized comparisons suggesting an improved outcome with ST

  7. Robot-assisted Versus Laparoscopic Surgery for Rectal Cancer: A Phase II Open Label Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Kim, Min Jung; Park, Sung Chan; Park, Ji Won; Chang, Hee Jin; Kim, Dae Yong; Nam, Byung-Ho; Sohn, Dae Kyung; Oh, Jae Hwan

    2018-02-01

    The phase II randomized controlled trial aimed to compare the outcomes of robot-assisted surgery with those of laparoscopic surgery in the patients with rectal cancer. The feasibility of robot-assisted surgery over laparoscopic surgery for rectal cancer has not been established yet. Between February 21, 2012 and March 11, 2015, patients with rectal cancer (cT1-3NxM0) were enrolled. Patients were randomized 1:1 to either robot-assisted or laparoscopic surgery, and stratified per sex and administration of preoperative chemoradiotherapy. The primary outcome was the quality of total mesorectal excision (TME) specimen. Secondary outcomes were the circumferential and distal resection margins, the number of harvested lymph nodes, morbidity, bowel function recovery, and quality of life. A total of 163 patients were randomly assigned to the robot-assisted (n = 81) and laparoscopic (n = 82) surgery groups, and 139 patients were eligible for the analyses (73 vs 66, respectively). One patient (1.2%) in the robot-assisted group was converted to open surgery. The TME quality did not differ between the robot-assisted and laparoscopic groups (80.3% vs 78.1% complete TME, respectively; 18.2% vs 21.9% nearly complete TME, respectively; P = 0.599). The resection margins, number of harvested lymph nodes, morbidity, and bowel function recovery also were not significantly different. On analyzing quality of life, scores of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ C30) and EORTC QLQ CR38 were similar in the 2 groups, but in the EORTC QLQ CR 38 questionnaire, sexual function 12 months postoperatively was better in the robot-assisted group than in the laparoscopic group (P = 0.03). Robot-assisted surgery in rectal cancer showed TME quality comparable with that of laparoscopic surgery, and it demonstrated similar postoperative morbidity, bowel function recovery, and quality of life.

  8. Chemoradiation of hepatic malignancies: prospective, phase 1 study of full-dose capecitabine with escalating doses of yttrium-90 radioembolization.

    Science.gov (United States)

    Hickey, Ryan; Mulcahy, Mary F; Lewandowski, Robert J; Gates, Vanessa L; Vouche, Michael; Habib, Ali; Kircher, Sheetal; Newman, Steven; Nimeiri, Halla; Benson, Al B; Salem, Riad

    2014-04-01

    Radiosensitizing chemotherapy improves the outcomes in comparison with radiation alone for gastrointestinal cancers. The delivery of radiation therapy with yttrium90 ((90)Y) radioembolization, in combination with the radiosensitizing chemotherapeutic agent capecitabine, provides the opportunity to enhance the effects of radiation on hepatic malignancies. This phase 1 study sought to determine the maximum tolerated dose (MTD) of (90)Y plus capecitabine in patients with cholangiocarcinoma or liver metastases confined to the liver. Patients were given initial treatment at full-dose capecitabine during days 1 to 14 of a 21-day cycle. At days 1 to 7 of the second cycle, whole-liver (90)Y was given at the test dose, after which time capecitabine was continued. Dose-limiting toxicity (DLT) was determined 6 weeks after (90)Y infusion. If a DLT was not observed, the (90)Y dose was escalated. The planned dose cohorts were 110, 130, 150, and 170 Gy. The primary endpoint was to determine the MTD of (90)Y with full-dose capecitabine. Sixteen patients were treated according to the study protocol. Two patients experienced DLTs. Nine patients required capecitabine dose reduction as a result of toxicities attributable to capecitabine alone. The criteria for establishing (90)Y MTD were not met, indicating an MTD of >170 Gy. The MTD of (90)Y delivered in conjunction with capecitabine in the setting of intrahepatic cholangiocarcinoma or metastatic disease confined to the liver exceeds 170 Gy. This is the highest (90)Y dose reported to date and has important implications on combined therapy with the radiosensitizing oral chemotherapeutic capecitabine. Further studies are under way. Copyright © 2014 Elsevier Inc. All rights reserved.

  9. Chemoradiation of Hepatic Malignancies: Prospective, Phase 1 Study of Full-Dose Capecitabine With Escalating Doses of Yttrium-90 Radioembolization

    Energy Technology Data Exchange (ETDEWEB)

    Hickey, Ryan [Department of Radiology, Section of Interventional Radiology, Northwestern Memorial Hospital, Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois (United States); Mulcahy, Mary F. [Division of Hematology and Oncology, Department of Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois (United States); Lewandowski, Robert J.; Gates, Vanessa L.; Vouche, Michael; Habib, Ali [Department of Radiology, Section of Interventional Radiology, Northwestern Memorial Hospital, Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois (United States); Kircher, Sheetal; Newman, Steven; Nimeiri, Halla; Benson, Al B. [Division of Hematology and Oncology, Department of Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois (United States); Salem, Riad, E-mail: r-salem@northwestern.edu [Department of Radiology, Section of Interventional Radiology, Northwestern Memorial Hospital, Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois (United States); Division of Hematology and Oncology, Department of Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois (United States)

    2014-04-01

    Purpose: Radiosensitizing chemotherapy improves the outcomes in comparison with radiation alone for gastrointestinal cancers. The delivery of radiation therapy with yttrium90 ({sup 90}Y) radioembolization, in combination with the radiosensitizing chemotherapeutic agent capecitabine, provides the opportunity to enhance the effects of radiation on hepatic malignancies. This phase 1 study sought to determine the maximum tolerated dose (MTD) of {sup 90}Y plus capecitabine in patients with cholangiocarcinoma or liver metastases confined to the liver. Methods and Materials: Patients were given initial treatment at full-dose capecitabine during days 1 to 14 of a 21-day cycle. At days 1 to 7 of the second cycle, whole-liver {sup 90}Y was given at the test dose, after which time capecitabine was continued. Dose-limiting toxicity (DLT) was determined 6 weeks after {sup 90}Y infusion. If a DLT was not observed, the {sup 90}Y dose was escalated. The planned dose cohorts were 110, 130, 150, and 170 Gy. The primary endpoint was to determine the MTD of {sup 90}Y with full-dose capecitabine. Results: Sixteen patients were treated according to the study protocol. Two patients experienced DLTs. Nine patients required capecitabine dose reduction as a result of toxicities attributable to capecitabine alone. The criteria for establishing {sup 90}Y MTD were not met, indicating an MTD of >170 Gy. Conclusion: The MTD of {sup 90}Y delivered in conjunction with capecitabine in the setting of intrahepatic cholangiocarcinoma or metastatic disease confined to the liver exceeds 170 Gy. This is the highest {sup 90}Y dose reported to date and has important implications on combined therapy with the radiosensitizing oral chemotherapeutic capecitabine. Further studies are under way.

  10. Evaluation of an advanced pressure ulcer management protocol followed by trained wound, ostomy, and continence nurses: a non-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kaitani T

    2015-02-01

    Full Text Available Toshiko Kaitani,1 Gojiro Nakagami,2 Junko Sugama,3 Masahiro Tachi,4 Yutaka Matsuyama,5 Yoshiki Miyachi,6 Takashi Nagase,2 Yukie Takemura,7 Hiromi Sanada2 1School of Nursing, Sapporo City University, Hokkaido, Japan; 2Department of Gerontological Nursing/Wound Care Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; 3Department of Clinical Nursing, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan; 4Department of Plastic Surgery, Tohoku University Graduate School of Medicine, Miyagi, Japan; 5Department of Biostatistics, School of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan; 6Department of Dermatology, Kyoto University Graduate School of Medicine, Kyoto, Japan; 7Department of Nursing, Research Hospital, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan Aims and objectives: We investigated the effectiveness and safety of an advanced pressure ulcer (PU management protocol comprising 1 ultrasonography to assess the deep tissue, 2 use of a non-contact thermometer to detect critical colonization, 3 conservative sharp debridement, 4 dressing selection, 5 negative pressure wound therapy, and 6 vibration therapy in comparison with those of a conventional approach. Each protocol was followed by trained wound, ostomy, and continence nurses (WOCNs. Background: At present, there is no systematic PU management protocol for nurses that includes appropriate assessment and intervention techniques for deep tissue injury and critical colonization. In Japan, there is no such protocol that the nurses can follow without a physician’s orders. Design and methods: This was a prospective non-randomized controlled trial. Over a 3-week period, we evaluated the effectiveness of an advanced protocol by comparing the PU severity and healing on the basis of the DESIGN-R scale and presence of patients' discomfort. We recruited ten WOCNs to follow

  11. A prospective phase II randomized study of deferasirox to prevent iatrogenic iron overload in patients undertaking induction/consolidation chemotherapy for acute myeloid leukaemia.

    Science.gov (United States)

    Kennedy, Glen A; Morris, Kirk L; Subramonpillai, Elango; Curley, Cameron; Butler, Jason; Durrant, Simon

    2013-06-01

    This prospective randomized phase II study aimed to determine the safety and efficacy of deferasirox in preventing iatrogenic iron overload in patients receiving induction/consolidation chemotherapy for acute myeloid leukaemia (AML) ize. Serum ferritin, transferrin saturation and CRP were measured pre-, mid- and post- each chemotherapy cycle. Patients were randomized to receive either therapy with deferasirox vs. no deferasirox therapy once serum ferritin increased to >500 μg/l. The trial was stopped prematurely due to excess gastrointestinal (GI) and infectious toxicity demonstrable in the deferasirox arm, after 10 patients had been randomized to deferasirox and 6 patients to the control arm. Overall, deferasirox was poorly tolerated, with median maximum tolerated dose only 13·8 mg/kg/d and no patient able to tolerate doses >20 mg/kg/d. Median duration of deferasirox therapy was only 72 d (range 19-130 d), with 9/10 patients requiring unplanned dose interruptions and 4/10 patients unable to continue the drug predominantly due to GI effects. Although all 3 treatment-related deaths occurred in the deferasirox arm (P = 0·25), median overall survival was similar between treatment arms. Use of deferasirox to prevent iatrogenic iron overload in AML patients undertaking induction/consolidation is poorly tolerated and appears to be associated with excess GI and infectious toxicity. © 2013 John Wiley & Sons Ltd.

  12. Pre-fracture nutritional status is predictive of functional status at discharge during the acute phase with hip fracture patients: A multicenter prospective cohort study.

    Science.gov (United States)

    Inoue, Tatsuro; Misu, Syogo; Tanaka, Toshiaki; Sakamoto, Hiroki; Iwata, Kentaro; Chuman, Yuki; Ono, Rei

    2017-10-01

    Malnutrition is common in patients with hip fractures, and elderly patients with hip fractures lose functional independence and often fail to recover previous functional status. The aim of this study was to determine whether pre-fracture nutritional status predicts functional status of patients with hip fracture at discharge from acute hospitals. In the present multicenter prospective cohort study, pre-fracture nutritional status was assessed using the Mini Nutritional Assessment Short-Form (MNA-SF). At discharge from acute hospitals, functional status was evaluated using a functional independent measurement instrument (FIM). Subsequently, multiple regression analyses were performed using FIM as the dependent variable and MNA-SF as the independent variable. Among the 204 patients analyzed in the present study, the mean length of hospital stay was 26.2 ± 12.6 days, and according to MNA-SF assessments, 51 (25.0%) patients were malnourished, 98 (48.0%) were at risk of malnutrition, and 55 (27.0%) were well-nourished before fracture. At discharge, FIM scores were higher in patients who were well-nourished than in those who were malnourished or were at risk of malnutrition (p nutritional status was a significant independent predictor for functional status at discharge during the acute phase, warranting early assessment of nutritional status and early intervention for successful postoperative rehabilitation. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  13. A dermatitis control program (DeCoP) for head and neck cancer patients receiving radiotherapy. A prospective phase II study

    International Nuclear Information System (INIS)

    Zenda, Sadamoto; Ishi, Shinobu; Kawashima, Mitsuhiko; Arahira, Satoko; Ichihashi, Tomiko; Tahara, Makoto; Hayashi, Ryuichi; Kishimoto, Seiji

    2013-01-01

    We speculated that a systematic program to manage radiation dermatitis might decrease the incidence of severe or fatal cases in head and neck cancer patients receiving radiotherapy. Here, we conducted a prospective phase II study to clarify the clinical benefit of a Dermatitis Control Program (DeCoP) that did not use corticosteroids. Head and neck cancer patients scheduled to receive definitive or postoperative radiotherapy were enrolled. Radiation dermatitis was managed with a DeCoP consisting of a three-step ladder: gentle washing; gentle washing and moistening of the wound-healing environment; prevention against infection, gentle washing and moistening of the wound-healing environment. The primary endpoint was the incidence of grade 4 dermatitis. A total of 113 patients were registered between January 2009 and February 2010. Eighty patients received radiotherapy as an initial approach, while the remaining 33 received radiotherapy postoperatively. Grade 3 and 4 dermatitis events occurred in 11 (9.7%) and 0 (0%, 95% confidence interval 0-3.2%) patients, respectively. Median radiation dose at the onset of grade 2 dermatitis was 61.5 Gy (range 36-70 Gy) and median period between onset and recovery was 14 days (range 1-46 days). The Dermatitis Control Program has promising clinical potential. Radiation dermatitis might be manageable if gentle washing and moistening of the wound-healing environment is done. (author)

  14. New Vision for Improving the Oral Health Education of Visually Impaired Children- A Non Randomized Control Trial.

    Science.gov (United States)

    Debnath, Arpan; Srivastava, B K; Shetty, Punith; Eshwar, Shruthi

    2017-07-01

    Visually impaired people have poorer oral hygiene when compared to others. Therefore, there is a necessity for individual training by making awareness in oral care and plaque control so as to improve their oral hygiene. The aim of the present study was to assess the effectiveness of oral health innovative educative method among visually impaired children of Bengaluru city of India. A non-randomized control trial was conducted among 40 visually impaired individuals attending special school for blind. The study was conducted for a duration of six months. Baseline data regarding oral health knowledge, attitude and practices was obtained through a questionnaire in Braille and oral plaque assessment was done using Silness and Loe plaque index (1964). Music based brushing technique, cast models and an oral health education talk and booklet in Braille was delivered stressing on importance of oral health. The results of Knowledge, Attitude and Practices (KAP) before and after health education were analysed using Chi-square test with SPSS version 22.0. The overall KAP was lower in the preintervention period among the visually impaired children with mean score of 6.98 while after the modified oral health education session, it was increased to a mean score of 14.68 which was statistically significant at poral plaque scores with 80% of the children having fair scores in the preintervention period to 30% in the postintervention period. This oral health education module showed good results which can be implemented to effectively increase the awareness about dental health.

  15. Randomly and Non-Randomly Missing Renal Function Data in the Strong Heart Study: A Comparison of Imputation Methods.

    Directory of Open Access Journals (Sweden)

    Nawar Shara

    Full Text Available Kidney and cardiovascular disease are widespread among populations with high prevalence of diabetes, such as American Indians participating in the Strong Heart Study (SHS. Studying these conditions simultaneously in longitudinal studies is challenging, because the morbidity and mortality associated with these diseases result in missing data, and these data are likely not missing at random. When such data are merely excluded, study findings may be compromised. In this article, a subset of 2264 participants with complete renal function data from Strong Heart Exams 1 (1989-1991, 2 (1993-1995, and 3 (1998-1999 was used to examine the performance of five methods used to impute missing data: listwise deletion, mean of serial measures, adjacent value, multiple imputation, and pattern-mixture. Three missing at random models and one non-missing at random model were used to compare the performance of the imputation techniques on randomly and non-randomly missing data. The pattern-mixture method was found to perform best for imputing renal function data that were not missing at random. Determining whether data are missing at random or not can help in choosing the imputation method that will provide the most accurate results.

  16. Treatment of age-related subfoveal neovascular membranes by teletherapy. Results of a non-randomized study

    Energy Technology Data Exchange (ETDEWEB)

    Subasi, M.; Akmansu, M.; Or, M. [Gazi Univ., Ankara (Turkey). Medical Faculty

    1999-03-01

    This investigation was designed to determine whether low-dose radiation to the macular region could influence the natural course of age-related subfoveal neovascularization. Thirty-one patients with subfoveal membranes due to age-related macular degeneration (ARMD) were treated with 12 Gy of 6 MV X-rays, and 72 patients who were untreated served as a control group. Both groups were followed-up. At six months of follow-up visual acuity was maintained in 54.8% and improved 25.8% of patients treated by radiotherapy. In the control group, visual acuity showed deterioration in 55.5%. There was a significant difference between the treated and untreated groups (p<0.01). Significant neovascular membrane regression or stabilization was recorded in 61.3% of treated patients at six months post-radiation, whereas the membranes in all. 72 control patients showed progressive enlargement. This non-randomized study suggested that low doses of radiation may be an alternative treatment for ARMD without an immediate drop in visual acuity or significant radiation morbidity. (author)

  17. School refusal and anxiety in adolescence: non-randomized trial of a developmentally sensitive cognitive behavioral therapy.

    Science.gov (United States)

    Heyne, David; Sauter, Floor M; Van Widenfelt, Brigit M; Vermeiren, Robert; Westenberg, P Michiel

    2011-10-01

    The main objectives were to evaluate efficacy and acceptability of a developmentally sensitive cognitive behavioral therapy for anxiety-based school refusal in adolescence. Twenty school-refusing adolescents meeting DSM-IV anxiety disorder criteria participated in a non-randomized trial, together with parents and school staff. Outcome was assessed at post-treatment and 2-month follow-up. Treated adolescents showed significant and maintained improvements across primary outcome variables (school attendance; school-related fear; anxiety), with medium to large effect sizes. Half of the adolescents were free of any anxiety disorder at follow-up. Additional improvements were observed across secondary outcome variables (depression; overall functioning; adolescent and parent self-efficacy). The treatment was rated as acceptable by adolescents, parents, and school staff, which may help explain the very low attrition rate. Social anxiety disorder was the most common disorder among adolescents still meeting anxiety disorder criteria at follow-up. Treatment modifications to improve efficacy for school-refusing adolescents presenting with social anxiety disorder are suggested. Copyright © 2011 Elsevier Ltd. All rights reserved.

  18. Does balneotherapy with low radon concentration in water influence the endocrine system? A controlled non-randomized pilot study.

    Science.gov (United States)

    Nagy, Katalin; Berhés, István; Kovács, Tibor; Kávási, Norbert; Somlai, János; Bender, Tamás

    2009-08-01

    Radon bath is a well-established modality of balneotherapy for the management of degenerative musculoskeletal disorders. The present study was conducted to ascertain whether baths of relatively low (80 Bq/l) radon concentration have any influence on the functioning of the endocrine system. In the study, a non-randomized pilot study, 27 patients with degenerative musculoskeletal disorders received 30-min radon baths (of 31-32 degrees C temperature and 80 Bq/l average radon concentration) daily, for 15 days. Twenty-five patients with matching pathologies were subjected to balneotherapy according to the same protocol, using thermal water with negligible radon content (6 Bq/l). Serum thyroid stimulating hormone, prolactin, cortisol, adrenocorticotropic hormone, and dehydroepiandrosterone levels were measured before and after a balneotherapy course of 15 sessions. Comparison of the accumulated data using the Wilcoxon test did not reveal any significant difference between pre- and post-treatment values or between the two patient groups. It is noted that while the beneficial effects of balneotherapy with radon-containing water on degenerative disorders is widely known, only few data have been published in the literature on its effect on endocrine functions. The present study failed to demonstrate any substantial effect of thermal water with relatively low radon content on the functioning of the endocrine system.

  19. Prospective phase II trial of trabectedin in BRCA-mutated and/or BRCAness phenotype recurrent ovarian cancer patients: the MITO 15 trial.

    Science.gov (United States)

    Lorusso, D; Scambia, G; Pignata, S; Sorio, R; Amadio, G; Lepori, S; Mosconi, A; Pisano, C; Mangili, G; Maltese, G; Sabbatini, R; Artioli, G; Gamucci, T; Di Napoli, M; Capoluongo, E; Ludovini, V; Raspagliesi, F; Ferrandina, G

    2016-03-01

    Current evidence suggest that trabectedin is particularly effective in cells lacking functional homologous recombination repair mechanisms. A prospective phase II trial was designed to evaluate the activity of trabectedin in the treatment of recurrent ovarian cancer patients presenting BRCA mutation and/or BRCAness phenotype. A total of 100 patients with recurrent BRCA-mutated ovarian cancer and/or BRCAness phenotype (≥2 previous responses to platinum) were treated with trabectedin 1.3 mg/mq i.v. q 3 weeks. The activity of the drug with respect to BRCA mutational status and to a series of polymorphisms [single-nucleotide polymorphisms (SNPs)] involved in DNA gene repair was analyzed. Ninety-four were evaluable for response; in the whole population, 4 complete and 33 partial responses were registered for an overall response rate (ORR) of 39.4. In the platinum-resistant (PR) and -sensitive (PS) population, an ORR of 31.2% and 47.8%, and an overall clinical benefit of 54.2% and 73.9%, respectively, were registered. In the whole series, the median progression-free survival (PFS) was 18 weeks and the median overall survival (OS) was 72 weeks; PS patients showed a more favorable PFS and OS compared with PR patients. BRCA gene mutational status was available in 69 patients. There was no difference in ORR, PFS and OS according to BRCA 1-2 status nor any association between SNPs of genes involved in DNA repair and NER machinery and response to trabectedin was reported. Our data prospectively confirmed that the signature of 'repeated platinum sensitivity' identifies patients highly responsive to trabectedin. In this setting, the activity of trabectedin seems comparable to what could be obtained using platinum compounds and the drug may represent a valuable alternative option in patients who present contraindication to receive platinum. 2011-001298-17. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights

  20. Treated Hypertension has No Influence on the Efficacy of Alendronate in the Therapy of Postmenopausal Osteoporosis: A Non-Randomized, Non-Blind, Controlled Prospective Study

    OpenAIRE

    Matziolis, Doerte; Drewke, Monika; Matziolis, Georg; Perka, Carsten

    2011-01-01

    Changes in hormone metabolism during menopause are involved in the development of osteoporosis and arterial hypertension. A mutual influence of these two clinical pictures is evident on the basis of pathophysiological factors. In this study, we investigated whether a drug therapy of hypertension influences the efficacy of a bisphosphonate (alendronate) in the treatment of postmenopausal osteoporosis. For this purpose, 60 female patients were enrolled in the study, 30 of them on drug treatment...

  1. GEMCYTABIN (CYTOGEM® AND CISPLATIN AS FIRST-LINE THERAPY FOR ADVANCED BLADDER CANCER: RESULTS OF A PROSPECTIVE OPEN-LABELED NON-COMPARATIVE NON-RANDOMIZED STUDY

    Directory of Open Access Journals (Sweden)

    V. B. Matveev

    2009-01-01

    Full Text Available Purpose.  The primary end-points of the study were overall response rate, progressive-free and overall survival in patients received Gemcytabin (Cytogem® and Cisplatin as first-line therapy for transitional-cell bladder cancer. Secondary end-points were toxicity and safty of the regimen. Material. From February 2005 to March 2007 25 patients with morphologically verified inoperable locally advanced and metastatic transitional-cell bladder cancer were recruited. Men-to-women ratio was 3:1. Median age of the patients was 66,5±6,8 years. All the patients received Cytogem® 1000 mg/m2 days 1, 8, 15, cisplatin 70 mg/m2 on day 2; every 28 days. No more than 6 cycles were allowed if the evidence of disease progression and unacceptable toxicity were not registered. Median follow-up was 36,2±12,1 months.  Results. Complete response was observed in 2 (8%, partial — in 11 (44%, stabilization — in 10 (40%, progression — in 2 (8% of 25 patients. Twelve- and 24-month overall survival was — 51,3% and 22,4% (median 13,4±3,5 (95% CI: 6,6—20,4 months, progressive- free survival — 26% and 13% respectively (median 8,8±1 (95% CI: 6,6—10,6 months. Toxicity was evaluated in 24 patients and occurred in all cases (grade I—II — 16 (67%, grade III—IV — 8 (33%. The main regimen-related toxicity was hematological (neutropenia — 16 (67% (grade I—II — 8 (33%, grade III—IV — 8 (33%, thrombocytopenia — 14 (58% (grade I—II — 10 (41,5%, grade III—IV — 4 (16,5%, anemia — 7 (29% (grade I—II — 5 (21%, grade III—IV — 2 (8%. Hematological toxicity was not associated with com- plications in any case. Non-hematological side-effects were nausea and vomiting in 21 (88% (grade I—II — 67%, grade III — 21%, alopecia — in 11 (44% patients. The regimen-related toxicity was considerable and reversible. No side-effect demanded blood transfusion, antibiotic and/or growth factors administration, and hospital admission.  Conclusion. Gemcytabin (Cytogem® and Cisplatin as first-line therapy for advanced transitional-cell bladder cancer have demonstrated satisfactory efficacy and acceptable toxicity. The regimen can be recommended for the clinical practice.  

  2. GEMCYTABIN (CYTOGEM® AND CISPLATIN AS FIRST-LINE THERAPY FOR ADVANCED BLADDER CANCER: RESULTS OF A PROSPECTIVE OPEN-LABELED NON-COMPARATIVE NON-RANDOMIZED STUDY

    Directory of Open Access Journals (Sweden)

    V. B. Matveev

    2014-08-01

    Full Text Available Purpose.  The primary end-points of the study were overall response rate, progressive-free and overall survival in patients received Gemcytabin (Cytogem® and Cisplatin as first-line therapy for transitional-cell bladder cancer. Secondary end-points were toxicity and safty of the regimen. Material. From February 2005 to March 2007 25 patients with morphologically verified inoperable locally advanced and metastatic transitional-cell bladder cancer were recruited. Men-to-women ratio was 3:1. Median age of the patients was 66,5±6,8 years. All the patients received Cytogem® 1000 mg/m2 days 1, 8, 15, cisplatin 70 mg/m2 on day 2; every 28 days. No more than 6 cycles were allowed if the evidence of disease progression and unacceptable toxicity were not registered. Median follow-up was 36,2±12,1 months.  Results. Complete response was observed in 2 (8%, partial — in 11 (44%, stabilization — in 10 (40%, progression — in 2 (8% of 25 patients. Twelve- and 24-month overall survival was — 51,3% and 22,4% (median 13,4±3,5 (95% CI: 6,6—20,4 months, progressive- free survival — 26% and 13% respectively (median 8,8±1 (95% CI: 6,6—10,6 months. Toxicity was evaluated in 24 patients and occurred in all cases (grade I—II — 16 (67%, grade III—IV — 8 (33%. The main regimen-related toxicity was hematological (neutropenia — 16 (67% (grade I—II — 8 (33%, grade III—IV — 8 (33%, thrombocytopenia — 14 (58% (grade I—II — 10 (41,5%, grade III—IV — 4 (16,5%, anemia — 7 (29% (grade I—II — 5 (21%, grade III—IV — 2 (8%. Hematological toxicity was not associated with com- plications in any case. Non-hematological side-effects were nausea and vomiting in 21 (88% (grade I—II — 67%, grade III — 21%, alopecia — in 11 (44% patients. The regimen-related toxicity was considerable and reversible. No side-effect demanded blood transfusion, antibiotic and/or growth factors administration, and hospital admission.  Conclusion. Gemcytabin (Cytogem® and Cisplatin as first-line therapy for advanced transitional-cell bladder cancer have demonstrated satisfactory efficacy and acceptable toxicity. The regimen can be recommended for the clinical practice.  

  3. Continuation of injectable contraception when self-injected v. administered by a facility-based health worker: A non-randomized, prospective cohort study in Uganda.

    Science.gov (United States)

    Cover, Jane; Namagembe, Allen; Tumusiime, Justine; Nsangi, Damalie; Lim, Jeanette; Nakiganda-Busiku, Dinah

    2018-04-10

    The purpose of this study was to compare 12-month continuation rates for DMPA-SC administered via self-injection and DMPA-IM administered by a health worker in Uganda. Women seeking injectable contraception at participating health facilities were offered the choice of self-injecting DMPA-SC or receiving an injection of DMPA-IM from a health worker. Those opting for self-injection were trained one-on-one. They self-injected under supervision and took home three units, a client instruction guide, and a reinjection calendar. Those opting for DMPA-IM received an injection and an appointment card for the next facility visit in three months. We interviewed participants at baseline (first injection) and after three (second injection), six (third injection), and nine (fourth injection) months, or upon discontinuation. We used Kaplan-Meier methods to estimate continuation probabilities, with a log-rank test to compare differences between groups. A multivariate Cox regression identified factors correlated with discontinuation. The twelve-month continuation rate for the 561 women self-injecting DMPA-SC was .81 (95% CI .78-.84) and for 600 women receiving DMPA-IM from a health worker, it was .65 (95% CI .61-.69), a significant difference at the 0.05 level. There were no differences in pregnancy rates or side-effects. The multivariate analysis revealed that, controlling for covariates, self-injecting reduced the hazard for discontinuing by 46%. A significant interaction between injection group and age suggests that self-injection may help younger women continue injectable use. The significant difference in 12-month continuation between women self-injecting DMPA-SC and women receiving DMPA-IM from a health worker-which remains significant in a multivariate analysis-suggests that self-injection may improve injectable contraceptive continuation. While injectable contraceptives are popular throughout much of sub-Saharan Africa, they have high rates of discontinuation. This study is the second from an African country to demonstrate that self-injection may improve injectable continuation rates and may do so without increasing the risk of pregnancy or adverse events. Copyright © 2018. Published by Elsevier Inc.

  4. A prospective phase II study

    DEFF Research Database (Denmark)

    Grønberg, Bjørn H; Bremnes, Roy M; Aasebø, Ulf

    2009-01-01

    , anemia was observed in 2 (6%) patients, leukopenia in 6 (18%), granulocytopenia in 9 (27%) and thrombocytopenia in 3 (9%). Febrile neutropenia occurred in 6 (18%) patients. There were no treatment related deaths. CONCLUSION: High-dose pemetrexed monotherapy to patients with recurrent SCLC yielded...

  5. Effectiveness of a 'Global Postural Reeducation' program for persistent low back pain: a non-randomized controlled trial.

    Science.gov (United States)

    Bonetti, Francesca; Curti, Stefania; Mattioli, Stefano; Mugnai, Raffaele; Vanti, Carla; Violante, Francesco S; Pillastrini, Paolo

    2010-12-16

    The aim of this non-randomized controlled trial was to evaluate the effectiveness of a Global Postural Reeducation (GPR) program as compared to a Stabilization Exercise (SE) program in subjects with persistent low back pain (LBP) at short- and mid-term follow-up (ie. 3 and 6 months). According to inclusion and exclusion criteria, 100 patients with a primary complaint of persistent LBP were enrolled in the study: 50 were allocated to the GPR group and 50 to the SE group. Primary outcome measures were Roland and Morris Disability Questionnaire (RMDQ) and Oswestry Disability Index (ODI). Secondary outcome measures were lumbar Visual Analogue Scale (VAS) and Fingertip-to-floor test (FFT). Data were collected at baseline and at 3/6 months by health care professionals unaware of the study. An intention to treat approach was used to analyze participants according to the group to which they were originally assigned. Of the 100 patients initially included in the study, 78 patients completed the study: 42 in the GPR group and 36 in the SE group. At baseline, the two groups did not differ significantly with respect to gender, age, BMI and outcome measures. Comparing the differences between groups at short- and mid-term follow-up, the GPR group revealed a significant reduction (from baseline) in all outcome measures with respect to the SE group.The ordered logistic regression model showed an increased likelihood of definitive improvement (reduction from baseline of at least 30% in RMDQ and VAS scores) for the GPR group compared to the SE group (OR 3.9, 95% CI 2.7 to 5.7). Our findings suggest that a GPR intervention in subjects with persistent LBP induces a greater improvement on pain and disability as compared to a SE program. These results must be confirmed by further studies with higher methodological standards, including randomization, larger sample size, longer follow-up and subgrouping of the LBP subjects. NCT00789204.

  6. A school intervention for mental health literacy in adolescents: effects of a non-randomized cluster controlled trial.

    Science.gov (United States)

    Skre, Ingunn; Friborg, Oddgeir; Breivik, Camilla; Johnsen, Lars Inge; Arnesen, Yngvild; Wang, Catharina Elisabeth Arfwedson

    2013-09-23

    "Mental health for everyone" is a school program for mental health literacy and prevention aimed at secondary schools (13-15 yrs). The main aim was to investigate whether mental health literacy, could be improved by a 3-days universal education programme by: a) improving naming of symptom profiles of mental disorder, b) reducing prejudiced beliefs, and c) improving knowledge about where to seek help for mental health problems. A secondary aim was to investigate whether adolescent sex and age influenced the above mentioned variables. A third aim was to investigate whether prejudiced beliefs influenced knowledge about available help. This non-randomized cluster controlled trial included 1070 adolescents (53.9% boys, M age 14 yrs) from three schools in a Norwegian town. One school (n = 520) received the intervention, and two schools (n = 550) formed the control group. Pre-test and follow-up were three months apart. Linear mixed models and generalized estimating equations models were employed for analysis. Mental health literacy improved contingent on the intervention, and there was a shift towards suggesting primary health care as a place to seek help. Those with more prejudiced beliefs did not suggest places to seek help for mental health problems. Generally, girls and older adolescents recognized symptom profiles better and had lower levels of prejudiced beliefs. A low cost general school program may improve mental health literacy in adolescents. Gender specific programs and attention to the age and maturity of the students should be considered when mental health literacy programmes are designed and tried out. Prejudice should be addressed before imparting information about mental health issues.

  7. Telomere disruption results in non-random formation of de novo dicentric chromosomes involving acrocentric human chromosomes.

    Directory of Open Access Journals (Sweden)

    Kaitlin M Stimpson

    2010-08-01

    Full Text Available Genome rearrangement often produces chromosomes with two centromeres (dicentrics that are inherently unstable because of bridge formation and breakage during cell division. However, mammalian dicentrics, and particularly those in humans, can be quite stable, usually because one centromere is functionally silenced. Molecular mechanisms of centromere inactivation are poorly understood since there are few systems to experimentally create dicentric human chromosomes. Here, we describe a human cell culture model that enriches for de novo dicentrics. We demonstrate that transient disruption of human telomere structure non-randomly produces dicentric fusions involving acrocentric chromosomes. The induced dicentrics vary in structure near fusion breakpoints and like naturally-occurring dicentrics, exhibit various inter-centromeric distances. Many functional dicentrics persist for months after formation. Even those with distantly spaced centromeres remain functionally dicentric for 20 cell generations. Other dicentrics within the population reflect centromere inactivation. In some cases, centromere inactivation occurs by an apparently epigenetic mechanism. In other dicentrics, the size of the alpha-satellite DNA array associated with CENP-A is reduced compared to the same array before dicentric formation. Extra-chromosomal fragments that contained CENP-A often appear in the same cells as dicentrics. Some of these fragments are derived from the same alpha-satellite DNA array as inactivated centromeres. Our results indicate that dicentric human chromosomes undergo alternative fates after formation. Many retain two active centromeres and are stable through multiple cell divisions. Others undergo centromere inactivation. This event occurs within a broad temporal window and can involve deletion of chromatin that marks the locus as a site for CENP-A maintenance/replenishment.

  8. Non Random Distribution of DMD Deletion Breakpoints and Implication of Double Strand Breaks Repair and Replication Error Repair Mechanisms.

    Science.gov (United States)

    Marey, Isabelle; Ben Yaou, Rabah; Deburgrave, Nathalie; Vasson, Aurélie; Nectoux, Juliette; Leturcq, France; Eymard, Bruno; Laforet, Pascal; Behin, Anthony; Stojkovic, Tanya; Mayer, Michèle; Tiffreau, Vincent; Desguerre, Isabelle; Boyer, François Constant; Nadaj-Pakleza, Aleksandra; Ferrer, Xavier; Wahbi, Karim; Becane, Henri-Marc; Claustres, Mireille; Chelly, Jamel; Cossee, Mireille

    2016-05-27

    Dystrophinopathies are mostly caused by copy number variations, especially deletions, in the dystrophin gene (DMD). Despite the large size of the gene, deletions do not occur randomly but mainly in two hot spots, the main one involving exons 45 to 55. The underlying mechanisms are complex and implicate two main mechanisms: Non-homologous end joining (NHEJ) and micro-homology mediated replication-dependent recombination (MMRDR). Our goals were to assess the distribution of intronic breakpoints (BPs) in the genomic sequence of the main hot spot of deletions within DMD gene and to search for specific sequences at or near to BPs that might promote BP occurrence or be associated with DNA break repair. Using comparative genomic hybridization microarray, 57 deletions within the intron 44 to 55 region were mapped. Moreover, 21 junction fragments were sequenced to search for specific sequences. Non-randomly distributed BPs were found in introns 44, 47, 48, 49 and 53 and 50% of BPs clustered within genomic regions of less than 700bp. Repeated elements (REs), known to promote gene rearrangement via several mechanisms, were present in the vicinity of 90% of clustered BPs and less frequently (72%) close to scattered BPs, illustrating the important role of such elements in the occurrence of DMD deletions. Palindromic and TTTAAA sequences, which also promote DNA instability, were identified at fragment junctions in 20% and 5% of cases, respectively. Micro-homologies (76%) and insertions or deletions of small sequences were frequently found at BP junctions. Our results illustrate, in a large series of patients, the important role of RE and other genomic features in DNA breaks, and the involvement of different mechanisms in DMD gene deletions: Mainly replication error repair mechanisms, but also NHEJ and potentially aberrant firing of replication origins. A combination of these mechanisms may also be possible.

  9. Large-area imaging reveals biologically driven non-random spatial patterns of corals at a remote reef

    Science.gov (United States)

    Edwards, Clinton B.; Eynaud, Yoan; Williams, Gareth J.; Pedersen, Nicole E.; Zgliczynski, Brian J.; Gleason, Arthur C. R.; Smith, Jennifer E.; Sandin, Stuart A.

    2017-12-01

    For sessile organisms such as reef-building corals, differences in the degree of dispersion of individuals across a landscape may result from important differences in life-history strategies or may reflect patterns of habitat availability. Descriptions of spatial patterns can thus be useful not only for the identification of key biological and physical mechanisms structuring an ecosystem, but also by providing the data necessary to generate and test ecological theory. Here, we used an in situ imaging technique to create large-area photomosaics of 16 plots at Palmyra Atoll, central Pacific, each covering 100 m2 of benthic habitat. We mapped the location of 44,008 coral colonies and identified each to the lowest taxonomic level possible. Using metrics of spatial dispersion, we tested for departures from spatial randomness. We also used targeted model fitting to explore candidate processes leading to differences in spatial patterns among taxa. Most taxa were clustered and the degree of clustering varied by taxon. A small number of taxa did not significantly depart from randomness and none revealed evidence of spatial uniformity. Importantly, taxa that readily fragment or tolerate stress through partial mortality were more clustered. With little exception, clustering patterns were consistent with models of fragmentation and dispersal limitation. In some taxa, dispersion was linearly related to abundance, suggesting density dependence of spatial patterning. The spatial patterns of stony corals are non-random and reflect fundamental life-history characteristics of the taxa, suggesting that the reef landscape may, in many cases, have important elements of spatial predictability.

  10. A phase II prospective, non-comparative assessment of a new silver sodium carboxymethylcellulose (AQUACEL(®) Ag BURN) glove in the management of partial thickness hand burns.

    Science.gov (United States)

    Duteille, Franck; Jeffery, Steven L A

    2012-11-01

    Nylon-reinforced silver sodium carboxymethylcellulose (AQUACEL(®) Ag BURN) dressings were developed to be pliable and conforming for the management of partial-thickness burns. This study evaluated the AQUACEL(®) Ag BURN glove for the management of hand burns. This 21-day, phase II, prospective, non-comparative study included 23 patients with partial-thickness hand burn of at least two fingers. The AQUACEL(®) Ag BURN glove was applied to one hand and could remain in place up to 21 days until clinically indicated to change the glove. Dressings were evaluated 1, 2, 4, 6, 8, 14, and 21 days after initial application. Safety was the primary study endpoint. Sixteen (70%) hand burns re-epithelialized fully over a mean of 15.6 days. Initial application was easy/very easy for 20 (87%) patients. Mean time for initial dressing application was 5.4 min. At final evaluation, most patients gave ratings of excellent/good for conformability (91%), overall glove performance (74%), and appropriateness of sizes (83%). Mean pain score from 0 (none) to 10 (worst imaginable) was 3.43 at baseline; during the study, mean scores were 1.15 at rest and 2.29 during movement. Of 61 glove removals, most (72%) were easy/very easy, and 12% had fallen off. Adverse events (wound site or elsewhere) occurred in 15 (65%) patients. Treatment-related adverse events were wound pain (17%), maceration (9%), and stiff fingers (4%). The AQUACEL(®) Ag BURN glove was well tolerated in the management of partial-thickness hand burn. Many patients used only one glove. When glove changes were required, they were usually quick and easy. Copyright © 2012 Elsevier Ltd and ISBI. All rights reserved.

  11. A prospective phase I/II trial of the cyclooxygenase-2 inhibitor celecoxib in patients with carcinoma of the cervix - acute toxicity and biomarker response analysis

    International Nuclear Information System (INIS)

    Chan, P.; Doll, C.; Oza, A.; Pintilie, M.; Levin, W.; Manchul, L.; Fyles, A.; Milosevic, M.

    2003-01-01

    To evaluate the toxicity and biomarker response of celecoxib (C) as a biologic modifier in combination with definitive chemoradiotherapy (CRT) in women with cervix cancer. Fifteen cervix patients were entered into the first phase of this prospective study between March 2001 and January 2002. FIGO stages included IB(2), IIB(8), IIIB(4), and IVA(1), and median age was 51 years (range 26-62). Celecoxib 400mg orally was given b.i.d. 2 weeks prior to, and during the CRT. Toxicity assessments were performed weekly up to 12 weeks following treatment prior to further accrual using the NCIC-CTC. Hypoxia (HP5) and interstitial fluid pressure (IFP) assays were performed at day 0 and 14. Eleven patients completed the prescribed therapy. Only 2 of 4 patients discontinued C due to GI toxicity. In total there were 6 (40%) with grade 3/4 acute toxicity. Four were related to GI, one to skin reaction while the other was haematological. Although it was difficult to distinguish CRT toxicity from C, the proportion of patients with severe acute toxicity was similar to what we previously reported with CRT alone (8/24 (33%), Rodrigues, IJROBP 2001:Vol 51:(3): (Supp 1): 334). GI toxicity was more common in this study whereas haematologic effects were more frequent in the previous study. Evaluating the most recent measurable data set, 6 of 16 patients showed a decrease in HP5, (3.8 - 89.7%) while 10 of 14 patients had a reduction in IFP, (1.3 - 16.2mmHg). Two grade 4 late GI toxicity developed. Celecoxib is tolerated by patients receiving CRT for cervix cancer. Response of microenvironmental biomarkers to C was seen in the majority, suggesting a role as early markers of treatment outcome. Further follow-up is needed to assess the risk of late toxicity. The trial has been re-opened with C reduced to 300 mg b.i.d

  12. Results of a prospective phase 2 clinical trial of induction gemcitabine/capecitabine followed by stereotactic ablative radiation therapy in borderline resectable or locally advanced pancreatic adenocarcinoma.

    Science.gov (United States)

    Quan, Kimmen; Sutera, Philip; Xu, Karen; Bernard, Mark E; Burton, Steven A; Wegner, Rodney E; Zeh, Herbert; Bahary, Nathan; Stoller, Ronald; Heron, Dwight E

    Stereotactic ablative radiation therapy's (SABR's) great conformity and short duration has become an attractive treatment modality. We report a phase 2 clinical trial to evaluate efficacy and safety of induction chemotherapy (ICT) followed by SABR in patient with borderline resectable (BR) and locally advanced (LA) pancreatic ductal adenocarcinoma (PDAC). Patients with biopsy-proven BR or LA PDAC were treated with four 21-day cycles of intravenous gemcitabine and oral capecitabine. Patients were restaged within 4 weeks after ICT by computed tomography and treated by 3-fraction SABR if no metastasis or progressive disease was identified. Patients were restaged 4 weeks following SABR to determine resectability. Tumor response was assessed with carbohydrate antigen 19-9. Thirty-five patients (19 BR/16 LA) were enrolled. The median age was 71.8 years (range, 50.6-81.1). ICT was completed in 91.4% (n = 32) of patients. All patients who completed ICT completed SABR. Of those 32 patients, 34.3% (n = 12: 10 BR, 2 LA) underwent pancreaticoduodenectomy and 11 of 12 (91.7%) received R0 resection. Median overall survival was 18.8, 28.3, and 14.3 months for the entire cohort, BR, and LA, respectively. The 2-year local progression-free survival (LPFS) was 44.9%, 40%, and 52% for the entire cohort, BR, and LA, respectively. For BR patients, multivariate analysis showed surgery was associated with better overall survival and LPFS. One-year LPFS for patients with surgery was 80% and 44% without surgery. Within the 15.4-month follow-up, no grade 3+ toxicity from SABR was observed. No significant quality of life change was observed before and after ICT, SABR, or surgery for BR or LA patients. This is the first prospective phase 2 study to investigate the feasibility and efficacy of a 12-week gemcitabine/capecitabine ICT followed by SABR for BR or LA PDAC. The results suggest excellent tolerability, high R0 resection rates, and acceptable posttreatment complications. Copyright © 2017

  13. Prospective Phase II Study of Brachytherapy Boost as a Component of Neo-Adjuvant Chemotherapy and External Beam Radiation Therapy in Locally Advanced Rectal Cancer

    International Nuclear Information System (INIS)

    EL-SAYED, M.E.; EL-TAHER, Z.H.

    2008-01-01

    The aim of the current study is to assess the response rate and toxicity profile in patients with locally advanced rectal cancer using brachytherapy (BT) boost following external beam radiotherapy (EBRT), concomitant with chemotherapy as a component of the neoadjuvant treatment. Patients and Methods: This is a prospective phase II study of neoadjuvant chemo-radiation therapy for patients with locally advanced rectal cancer who presented to the department of radiation oncology, King Abdul-Aziz University Hospital, Jeddah, Kingdom of Saudi Arabia. Seventeen patients had been included in the study. Radiation therapy was given as: phase I,45 Gy/25 fractions/5 weeks of EBRT, followed by brachytherapy boost (within one week after the end of EBRT) using high dose rate iridium 192 (Ir 192 ) aiming at 800 c Gy given in 2 fractions (each 400 c Gy) separated by 1 week. All patients received the same concomitant chemotherapy in the form of Capecitabine and Oxaliplatin. The clinical and pathological response rates, together with the toxicity profile were assessed. Results: Seventeen patients had been studied; the majority (14; 82%) were males, while 3 only (18%) were females, their mean age was 57.4 years. All patients had low anterior resection (LAR). The clinical response rate, assessed by digital rectal examination ± endoscopy examination 4 weeks after the end of EBRT and BT, revealed that complete clinical response (cCR) was noted in 3 patients (18%), clinical partial response (cPR) in 14 patients (82%); while the pathological response rate was: complete pathological response (pCR) in 8 patients (47%), pathological partial response (pPR) in 9 patients (53%). The toxicity profile showed that grade III radiation proctitis was seen in one patient (6%), grade III dermatitis in 2 (12%), while no patients developed grade III cystitis. For chemotherapy toxicities, three patients (18%) developed grade III nausea and/or vomiting, 2 (12%) developed grade III diarrhea. Conclusion

  14. Effectiveness of a 'Global Postural Reeducation' program for persistent Low Back Pain: a non-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Violante Francesco S

    2010-12-01

    Full Text Available Abstract Background The aim of this non-randomized controlled trial was to evaluate the effectiveness of a Global Postural Reeducation (GPR program as compared to a Stabilization Exercise (SE program in subjects with persistent low back pain (LBP at short- and mid-term follow-up (ie. 3 and 6 months. Methods According to inclusion and exclusion criteria, 100 patients with a primary complaint of persistent LBP were enrolled in the study: 50 were allocated to the GPR group and 50 to the SE group. Primary outcome measures were Roland and Morris Disability Questionnaire (RMDQ and Oswestry Disability Index (ODI. Secondary outcome measures were lumbar Visual Analogue Scale (VAS and Fingertip-to-floor test (FFT. Data were collected at baseline and at 3/6 months by health care professionals unaware of the study. An intention to treat approach was used to analyze participants according to the group to which they were originally assigned. Results Of the 100 patients initially included in the study, 78 patients completed the study: 42 in the GPR group and 36 in the SE group. At baseline, the two groups did not differ significantly with respect to gender, age, BMI and outcome measures. Comparing the differences between groups at short- and mid-term follow-up, the GPR group revealed a significant reduction (from baseline in all outcome measures with respect to the SE group. The ordered logistic regression model showed an increased likelihood of definitive improvement (reduction from baseline of at least 30% in RMDQ and VAS scores for the GPR group compared to the SE group (OR 3.9, 95% CI 2.7 to 5.7. Conclusions Our findings suggest that a GPR intervention in subjects with persistent LBP induces a greater improvement on pain and disability as compared to a SE program. These results must be confirmed by further studies with higher methodological standards, including randomization, larger sample size, longer follow-up and subgrouping of the LBP subjects. Trial

  15. Overweight and obesity in Slovak high school students and body composition indicators: a non-randomized cross-sectional study

    Directory of Open Access Journals (Sweden)

    Bibiana Vadasova

    2016-08-01

    Full Text Available Abstract Background Physical development can be considered as an indicator of the overall health status of the youth population. Currently, it appears that the increasing trend of the prevalence of obesity among children and youths has stopped in a number of countries worldwide. Studies point to the fact that adolescence is a critical period for the development of obesity. Body mass index (BMI seems to be an orientation parameter in the assessment of prevalence of obesity which is not sufficient for more accurate identification of at risk individuals. The purpose of this study was to evaluate association between BMI percentile zones as health-risk for being overweight and obese and body composition indicators in high-school students from the Prešov (Slovakia region. Methods A non-randomized cross-sectional study in high school students from the Prešov (Slovakia region was conducted. The research sample consisted of 1014 participants (boys n = 466, girls n = 549. Body composition was measured using direct segmental multi-frequency bioelectrical impedance analysis (DSM-BIA. To examine the association between obesity and selected body composition indicators, Kruskal-Wallis ANOVA and Eta2 were used. The relationship between selected body composition indicators and percentile BMI zones was determined using the Kendall tau correlation. Results In groups with different BMI percentile zones (normal weight, overweight, obese, ANOVA showed significant differences for girls and boys (p ˂.05 with high effect size (η2 ˂.26 in body weight, body fat mass index, body fat percentage, fat free mass index, fat-free mass percentage, visceral fat area, waist-to-hip ratio, waist circumference, protein mass and mineral mass. The highest degree of correlation among boys was between BMI values indicating overweight and obesity and fat free mass index and waist circumference, respectively (τ = .71, τ = .70, respectively. In girls, the highest

  16. Improvement of functional constipation with kiwifruit intake in a Mediterranean patient population: An open, non-randomized pilot study

    Directory of Open Access Journals (Sweden)

    Oriol Cunillera

    2015-07-01

    Full Text Available Introduction: Kiwifruit consumption has shown to improve functional constipation in healthy elderly population, according to studies in New Zealand and China. The aim of this study was to evaluate the effect of kiwifruit intake on functional constipation in a Mediterranean patient population characterized by its distinctive nutritional habits.Material and Methods: An open, non-controlled and non-randomized longitudinal study was conducted in 46 patients with constipation (Rome III criteria. Patients monitored for five weeks: weeks 1 and 2 no kiwifruit and weeks 3-5 three kiwifruit per day (Green kiwifruit, Actinidia deliciosa var Hayward. Bristol Scale, volume of stools, and ease of defecation was self- reported daily. The evolution of the categorical variables was tested using the Bhapkar test; functional data methodology was used for continuous variables, and Generalized Estimating Equation (GEE models were adjusted.Results: The percentage of patients with ≥3 stools per week increased from 82.61% (95% CI: 69–91.2 at week 1 to 97.78% (95% CI: 87.4–99.9 at week 2 of kiwifruit intake, with 76.09% (95% CI: 61.9–86.2 responding during the first week. The reporting of stable ideal stools increased from 17.39% (95% CI: 8.8–31 at week 2 to 33.33% (95% CI: 21.3–48 at week 5. According to GEE models, the number of depositions increased significantly (p-values<0.001 in 0.398 daily units at week 1 the first week of intake, up to 0.593 daily units at week 5; significant improvements on facility in evacuation and volume of evacuation were found from the firstweek of intake (all p-values<0.001.Conclusions: The intake of three kiwifruits per day significantly improves the quality of evacuation (number of depositions, volume, consistency and ease in a Mediterranean patient population suffering from functional constipation.

  17. PROSPECT: Optical Calibration System

    Science.gov (United States)

    Trinh, Ken; Prospect Collaboration

    2016-09-01

    The Precision Reactor Oscillation and SPECTrum Experiment (PROSPECT), is a short baseline, reactor neutrino experiment which focuses on measurements of the flux and energy spectrum of antineutrinos emitted from the High Flux Isotope Reactor (HFIR) at Oak Ridge National Laboratory. Using these measurements, PROSPECT will probe for eV-scale sterile neutrinos while making a high precision measurement of the U-235 antineutrino spectrum. PROSPECT contains two phases; the first phase consists of a mobile detector near the reactor core while the second phase adds a larger fixed detector further from the core. The PROSPECT Phase 1 detector consists of a 2ton optically segmented liquid scintillator with each segment read-out by two photomultiplier tubes (PMTs). The PMTs are calibrated with a photon source generated by a nanosecond pulsed laser. In this project, we developed a plan to determine the effectiveness of a 450nm fiber-pigtailed diode laser as it coupled with several modules including an optical fiber splitter, an optical diffuser, and an attenuator. The project tested for the system ability to deliver light uniformly to each of the cells in the detector. We will present the design and result of this project as well as discuss how it will be implemented in PROSPECT.

  18. Run charts revisited: a simulation study of run chart rules for detection of non-random variation in health care processes.

    Directory of Open Access Journals (Sweden)

    Jacob Anhøj

    Full Text Available A run chart is a line graph of a measure plotted over time with the median as a horizontal line. The main purpose of the run chart is to identify process improvement or degradation, which may be detected by statistical tests for non-random patterns in the data sequence.We studied the sensitivity to shifts and linear drifts in simulated processes using the shift, crossings and trend rules for detecting non-random variation in run charts.The shift and crossings rules are effective in detecting shifts and drifts in process centre over time while keeping the false signal rate constant around 5% and independent of the number of data points in the chart. The trend rule is virtually useless for detection of linear drift over time, the purpose it was intended for.

  19. Run charts revisited: a simulation study of run chart rules for detection of non-random variation in health care processes.

    Science.gov (United States)

    Anhøj, Jacob; Olesen, Anne Vingaard

    2014-01-01

    A run chart is a line graph of a measure plotted over time with the median as a horizontal line. The main purpose of the run chart is to identify process improvement or degradation, which may be detected by statistical tests for non-random patterns in the data sequence. We studied the sensitivity to shifts and linear drifts in simulated processes using the shift, crossings and trend rules for detecting non-random variation in run charts. The shift and crossings rules are effective in detecting shifts and drifts in process centre over time while keeping the false signal rate constant around 5% and independent of the number of data points in the chart. The trend rule is virtually useless for detection of linear drift over time, the purpose it was intended for.

  20. Chemoradiation With Concomitant Boosts Followed by Radical Surgery in Locally Advanced Cervical Cancer: Long-term Results of the ROMA-2 Prospective Phase 2 Study

    Energy Technology Data Exchange (ETDEWEB)

    Ferrandina, Gabriella, E-mail: gabriella.ferrandina@libero.it [Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome (Italy); Gambacorta, Antonietta [Division of Radiotherapy, Catholic University of the Sacred Heart, Rome (Italy); Gallotta, Valerio [Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome (Italy); Smaniotto, Daniela [Division of Radiotherapy, Catholic University of the Sacred Heart, Rome (Italy); Fagotti, Anna [Gynecologic Surgery, University of Perugia, Terni (Italy); Tagliaferri, Luca [Division of Radiotherapy, Catholic University of the Sacred Heart, Rome (Italy); Foti, Elvira; Fanfani, Francesco [Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome (Italy); Autorino, Rosa [Division of Radiotherapy, Catholic University of the Sacred Heart, Rome (Italy); Scambia, Giovanni [Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome (Italy); Valentini, Vincenzo [Division of Radiotherapy, Catholic University of the Sacred Heart, Rome (Italy)

    2014-11-15

    Purpose: This prospective, phase 2 study aimed at assessing the efficacy of accelerated fractionation radiation therapy by concomitant boosts (CBs) associated with chemoradiation therapy (CRT) of the whole pelvis, in improving the rate of pathological complete response (pCR) to treatment in patients with International Federation of Gynaecology and Obstetrics (FIGO) stage IB2-IVA locally advanced cervical cancer. Methods and Materials: Neoadjuvant CRT included conformal irradiation of the whole pelvis with a total dose of 39.6 Gy (1.8 cGy/fraction, 22 fractions), plus additional irradiation of primary tumor and parametria with 10.8 Gy administered with CBs (0.9 cGy/fraction, 12 fractions, every other day). Concomitant chemotherapy included cisplatin (20 mg/m{sup 2}, days 1-4 and 26-30 of treatment), and capecitabine (1300 mg/m{sup 2}/daily, orally) during the first 2 and the last 2 weeks of treatment. Radical hysterectomy plus pelvic with or without aortic lymphadenectomy was performed within 6 to 8 weeks from CRT. Toxicity was recorded according to Radiation Therapy Oncology Group toxicity criteria and Chassagne grading system. Based on the Simon design, 103 cases were required, and the regimen would be considered active if >45 pCR were registered (α error = 0.05; β error = 0.1). Results: pCR was documented in 51 cases (50.5%), and the regimen was considered active, according to the planned statistical assumptions. At median follow-up of 36 months (range: 7-85 months), the 3-year local failure rate was 7%, whereas the 3-year disease-free and overall survival rates were 73.0% and 86.1%, respectively. Grade 3 leukopenia and neutropenia were reported in only 1 and 2 cases, respectively. Gastrointestinal toxicity was always grade 1 or 2. Conclusions: Addition of CBs in the accelerated fractionation modality to the whole pelvis chemoradiation followed by radical surgery results in a high rate of pathologically assessed complete response to CRT and a very

  1. Acute Toxicity and Quality of Life in Patients With Prostate Cancer Treated With Protons or Carbon Ions in a Prospective Randomized Phase II Study--The IPI Trial.

    Science.gov (United States)

    Habl, Gregor; Uhl, Matthias; Katayama, Sonja; Kessel, Kerstin A; Hatiboglu, Gencay; Hadaschik, Boris; Edler, Lutz; Tichy, Diana; Ellerbrock, Malte; Haberer, Thomas; Wolf, Maja B; Schlemmer, Heinz-Peter; Debus, Jürgen; Herfarth, Klaus

    2016-05-01

    The purpose of this study was to compare safety and feasibility of proton therapy with that of carbon ion therapy in hypofractionated raster-scanned irradiation of the prostate, in a prospective randomized phase 2 trial. In this trial, 92 patients with localized prostate cancer were enrolled. Patients were randomized to receive either proton therapy (arm A) or carbon ion therapy (arm B) and treated with a total dose of 66 Gy(relative biological effectiveness [RBE]) administered in 20 fractions (single dose of 3.3 Gy[RBE]). Patients were stratified by the use of antihormone therapy. Primary endpoint was the combined assessment of safety and feasibility. Secondary endpoints were specific toxicities, prostate-specific antigen progression-free survival (PFS), overall survival (OS), and quality of life (QoL). Ninety-one patients completed therapy and have had a median follow-up of 22.3 months. Among acute genitourinary toxicities, grade 1 cystitis rates were 34.1% (39.1% in A; 28.9% in B) and 17.6% grade 2 (21.7% in A; 13.3% in B). Seven patients (8%) required urinary catheterization during treatment due to urinary retention, 5 of whom were in arm A. Regarding acute gastrointestinal toxicities, 2 patients treated with protons developed grade 3 rectal fistulas. Grade 1 radiation proctitis occurred in 12.1% (13.0% in A; 11.1% in B) and grade 2 in 5.5% (8.7% in A; 2.2% in B). No statistically significant differences in toxicity profiles between arms were found. Reduced QoL was evident mainly in fatigue, pain, and urinary symptoms during therapy and 6 weeks thereafter. All European Organization for Research and Treatment of Cancer QLQ-C30 and -PR25 scores improved during follow-up. Hypofractionated irradiation using either carbon ions or protons results in comparable acute toxicities and QoL parameters. We found that hypofractionated particle irradiation is feasible and may be safe. Due to the occurrence of gel in the rectal wall and the consecutive occurrence of 2 rectal

  2. Alopecia as surrogate marker for chemotherapy response in patients with primary epithelial ovarian cancer: a metaanalysis of four prospective randomised phase III trials with 5114 patients.

    Science.gov (United States)

    Sehouli, Jalid; Fotopoulou, Christina; Erol, Edibe; Richter, Rolf; Reuss, Alexander; Mahner, Sven; Lauraine, Eric Pujade; Kristensen, Gunnar; Herrstedt, Jörn; du Bois, Andreas; Pfisterer, Jacobus

    2015-05-01

    Alopecia is a common side-effect of chemotherapy and affects quality of life of cancer patients. Some patients and physicians believe that alopecia could be a surrogate marker for response to chemotherapy and impact on prognosis. However, this was never been tested in a sufficiently large cohort of ovarian cancer patients. We analysed retrospectively the meta-databank of four prospective randomised phase-III-trials with platinum- and taxane-based 1st-line-chemotherapy in patients with advanced epithelial ovarian cancer (EOC) regarding the impact of alopecia overall outcome. For 4705 (92.0%) of a total of 5114 EOC-patients alopecia was documented. They had received on median six cycle platinum-taxane chemotherapy (range 0-11) with 4186 (89.0%) having completed ⩾ 6 cycles. Worst alopecia grade was 0 in 2.4%, 1 in 2.9% and 2 in 94.7% of the patients. In a univariate analysis, including all patients, grade-0/1 alopecia was associated with significantly lower progression free survival (PFS) and overall survival (OS) compared to grade-2 alopecia. However when assessing only those patients who completed ⩾ 6 chemotherapy-cycles and hence eliminating the bias of lower total dose of treatment, alopecia failed to retain any significant impact on survival in the multivariate analysis. Merely the time point of alopecia onset was an independent prognostic factor of survival: patients who developed grade-2 alopecia up to cycle 3 had a significantly longer OS compared to patients who experienced alopecia later during therapy (hazard ratio (HR): 1.25; 95% confidence interval (CI): 1.04-1.50). Within a large EOC-patient cohort with 1st-line platinum- and taxane-based chemotherapy early onset alopecia appears to be significantly associated with a more favourable outcome in those patients who completed ⩾ 6 chemotherapy cycles. It remains to be elucidated if early onset alopecia is just a surrogate marker for higher sensitivity to chemotherapy or if other biological effects are

  3. User assessment of Norditropin NordiFlex®,a new prefilled growth hormone pen:a Phase IV multicenter prospective study

    Directory of Open Access Journals (Sweden)

    Tauber M

    2013-05-01

    Full Text Available Maithé Tauber,1 Delphine Jaquet,2 Monique Jesuran-Perelroizen,3 Marc Petrus,4 Anne Marie Bertrand,5 Regis Coutant6NordiFlex® French Study Group1Hôpital des Enfants, Toulouse, 2Novo Nordisk, La Défense Cédex, 3Cabinet d’Endocrinologie Pédiatrique, Toulouse, 4Centre Hospitalier de Bigorre, Tarbes, 5Centre Hospitalier Universitaire de Besançon, Besançon, 6Centre Hospitalier Universitaire Angers, Angers, FranceBackground/aim: In growth disorders, ensuring long-term growth hormone therapy (GHT remains a challenge that might compromise the clinical outcome. Consequently, strategies aiming at alleviating the burden of daily injection might improve the treatment benefit. The study reported here was performed to assess the ease of use of Norditropin NordiFlex® (Novo Nordisk, Princeton, NJ, USA compared with that of the devices previously used in children treated with GHT with recombinant somatropin.Methods: This Phase IV prospective, multicenter, open-label study was conducted in France. All patients received Norditropin NordiFlex for 6 weeks. Oral questionnaires were administered by the physician to the patients and/or the parents at inclusion and at the final visit.Results: This study included 103 patients aged between 6 and 17 years. The patients assessed Norditropin NordiFlex as significantly easier to use than their previous device (median value = 7.5, P < 0.001. Almost three-quarters of patients (64.4% preferred Norditropin NordiFlex to their previous device. Among physicians and nurses, 73% assessed Norditropin NordiFlex training as "very easy" and 26% as "easy." Norditropin NordiFlex improved patient autonomy, with 41% of patients able to self-inject the treatment.Conclusion: This study has shown that Norditropin NordiFlex is reliable, safe, and easy to use and most study patients preferred it to their previous device. These characteristics may improve the adherence to GHT.Keywords: growth hormone therapy, adherence, injection devices

  4. A Phase II prospective nonrandomized trial of magnetic resonance imaging-guided hematopoietic bone marrow-sparing radiotherapy for gastric cancer patients with concurrent chemotherapy

    Directory of Open Access Journals (Sweden)

    Wang J

    2016-05-01

    Full Text Available Jianyang Wang, Yuan Tian, Yuan Tangm, Xin Wang, Ning Li, Hua Ren, Hui Fang, Yanru Feng, Shulian Wang, Yongwen Song, Yueping Liu, Weihu Wang, Yexiong Li, Jing Jin Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People’s Republic of China Purpose: This study aimed to spare hematopoietical bone marrow (BM identified by magnetic resonance (MR radiation in order to alleviate acute hematologic toxicity (HT for gastric cancer patients treated with postoperative chemoradiotherapy (CRT.Methods: A prospective, open-label, single-arm Phase II study (Clinicaltrials.gov; NCT 01863420 was conducted in 25 patients with gastric cancer who were eligible for postoperative concurrent CRT. The MR images of vertebral body T8-L4 were fused with images of simulating computed tomography. Hematopoietical BM was contoured according to the MR and spared in radiotherapy plan. The CRT regimen consisted of daily capecitabine (1600 mg/m2/d and 45 Gy of radiation at 1.8 Gy per day. Primary endpoints were grade ≥3 HT that occurred within 2 months of initiation of CRT. The relationship between HT and dose–volume of BM was estimated by multivariable linear regression model.Results: Twenty four patients (96% had T3–4 disease and 22 (88% had disease with node positive. The median age was 53 years (range, 28–73 years. Before concurrent CRT, adjuvant chemotherapy was administered with a mean cycle of 4.3±0.5. Only five patients (20% developed grade 3–4 HT during treatment, among whom two (8.0% patients experienced grade 3–4 leucopenia, two (8.0% experienced neutropenia, and two (8.0% experienced thrombocytopenia, respectively. None of the patients showed grade 3–4 anemia. Multivariable linear regression revealed increased BM-V5 (P=0.03 and BM-V20 (P=0.002 were found to be significantly associated with decreased white blood cells nadirs in multivariable regression

  5. Fractionated Boron Neutron Capture Therapy in Locally Recurrent Head and Neck Cancer: A Prospective Phase I/II Trial

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Ling-Wei, E-mail: lwwang@vghtpe.gov.tw [Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan (China); National Yang-Ming University, Taiwan (China); Chen, Yi-Wei [Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan (China); National Yang-Ming University, Taiwan (China); Ho, Ching-Yin [National Yang-Ming University, Taiwan (China); Department of Otolaryngology, Taipei Veterans General Hospital, Taiwan (China); Hsueh Liu, Yen-Wan [Institute of Nuclear Engineering and Science, National Tsing Hua University, Taiwan (China); Chou, Fong-In [Institute of Nuclear Engineering and Science, National Tsing Hua University, Taiwan (China); Nuclear Science and Technology Development Center, National Tsing Hua University, Taiwan (China); Liu, Yuan-Hao [Nuclear Science and Engineering Department, Nanjing University of Aeronautics and Astronautics, Nanjing (China); Liu, Hong-Ming; Peir, Jinn-Jer [Nuclear Science and Technology Development Center, National Tsing Hua University, Taiwan (China); Jiang, Shiang-Huei [Institute of Nuclear Engineering and Science, National Tsing Hua University, Taiwan (China); Chang, Chi-Wei [National Yang-Ming University, Taiwan (China); Department of Nuclear Medicine, Taipei Veterans General Hospital, Taiwan (China); Liu, Ching-Sheng [Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan (China); National Yang-Ming University, Taiwan (China); Lin, Ko-Han [Taoyuan Veterans Hospital, Taiwan (China); Wang, Shyh-Jen [National Yang-Ming University, Taiwan (China); Department of Nuclear Medicine, Taipei Veterans General Hospital, Taiwan (China); Chu, Pen-Yuan [National Yang-Ming University, Taiwan (China); Department of Otolaryngology, Taipei Veterans General Hospital, Taiwan (China); Lo, Wen-Liang; Kao, Shou-Yen [National Yang-Ming University, Taiwan (China); Department of Stomatology, Taipei Veterans General Hospital, Taiwan (China); and others

    2016-05-01

    Purpose: To investigate the efficacy and safety of fractionated boron neutron capture therapy (BNCT) for recurrent head and neck (H&N) cancer after photon radiation therapy. Methods and Materials: In this prospective phase 1/2 trial, 2-fraction BNCT with intravenous L-boronophenylalanine (L-BPA, 400 mg/kg) was administered at a 28-day interval. Before each fraction, fluorine-18-labeled-BPA–positron emission tomography was conducted to determine the tumor/normal tissue ratio of an individual tumor. The prescription dose (D80) of 20 Gy-Eq per fraction was selected to cover 80% of the gross tumor volume by using a dose volume histogram, while minimizing the volume of oral mucosa receiving >10 Gy-Eq. Tumor responses and adverse effects were assessed using the Response Evaluation Criteria in Solid Tumors v1.1 and the Common Terminology Criteria for Adverse Events v3.0, respectively. Results: Seventeen patients with a previous cumulative radiation dose of 63-165 Gy were enrolled. All but 2 participants received 2 fractions of BNCT. The median tumor/normal tissue ratio was 3.4 for the first fraction and 2.5 for the second, whereas the median D80 for the first and second fraction was 19.8 and 14.6 Gy-Eq, respectively. After a median follow-up period of 19.7 months (range, 5.2-52 mo), 6 participants exhibited a complete response and 6 exhibited a partial response. Regarding acute toxicity, 5 participants showed grade 3 mucositis and 1 participant showed grade 4 laryngeal edema and carotid hemorrhage. Regarding late toxicity, 2 participants exhibited grade 3 cranial neuropathy. Four of six participants (67%) receiving total D80 > 40 Gy-Eq had a complete response. Two-year overall survival was 47%. Two-year locoregional control was 28%. Conclusions: Our results suggested that 2-fraction BNCT with adaptive dose prescription was effective and safe in locally recurrent H&N cancer. Modifications to our protocol may yield more satisfactory results in the future.

  6. An Approach to Distinguish between Plasticity and Non-random Distributions of Behavioral Types Along Urban Gradients in a Wild Passerine Bird

    Directory of Open Access Journals (Sweden)

    Philipp Sprau

    2017-08-01

    Full Text Available The impact of urbanization has been widely studied in the context of species diversity and life history evolution. Behavioral adaptation, by contrast, remains poorly understood because empirical studies rarely investigate the relative importance of two key mechanisms: plastic responses vs. non-random distributions of behavioral types. We propose here an approach that enables the simultaneous estimation of the respective roles of these distinct mechanisms. We investigated why risky behaviors are often associated with urbanization, using an urban nest box population of great tits (Parus major as a study system. We simultaneously and repeatedly quantified individual behavior (aggression and flight initiation distance as well as environmental factors characterizing level of urbanization (numbers of pedestrians, cars and cyclists. This enabled us to statistically distinguish plastic responses from patterns of non-random distributions of behavioral types. Data analyses revealed that individuals did not plastically adjust their behavior to the level of urbanization. Behavioral types were instead non-randomly distributed: bold birds occurred more frequently in areas with more cars and fewer pedestrians while shy individuals were predominantly found in areas with fewer cars and more pedestrians. These novel findings imply a major role for behavioral types in the evolutionary ecology of urban environments and call for the full integration of among- and within-individual variation in urban ecological studies.

  7. Mobilisation of hematopoietic CD34+ precursor cells in patients with acute stroke is safe--results of an open-labeled non randomized phase I/II trial.

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    Sandra Boy

    Full Text Available BACKGROUND: Regenerative strategies in the treatment of acute stroke may have great potential. Hematopoietic growth factors mobilize hematopoietic stem cells and may convey neuroprotective effects. We examined the safety, potential functional and structural changes, and CD34(+ cell-mobilization characteristics of G-CSF treatment in patients with acute ischemic stroke. METHODS AND RESULTS: Three cohorts of patients (8, 6, and 6 patients per cohort were treated subcutaneously with 2.5, 5, or 10 µg/kg body weight rhG-CSF for 5 consecutive days within 12 hrs of onset of acute stroke. Standard treatment included i.v. thrombolysis. Safety monitoring consisted of obtaining standardized clinical assessment scores, monitoring of CD34(+ stem cells, blood chemistry, serial neuroradiology, and neuropsychology. Voxel-guided morphometry (VGM enabled an assessment of changes in the patients' structural parenchyma. 20 patients (mean age 55 yrs were enrolled in this study, 5 of whom received routine thrombolytic therapy with r-tPA. G-CSF treatment was discontinued in 4 patients because of unrelated adverse events. Mobilization of CD34(+ cells was observed with no concomitant changes in blood chemistry, except for an increase in the leukocyte count up to 75,500/µl. Neuroradiological and neuropsychological follow-up studies did not disclose any specific G-CSF toxicity. VGM findings indicated substantial atrophy of related hemispheres, a substantial increase in the CSF space, and a localized increase in parenchyma within the ischemic area in 2 patients. CONCLUSIONS: We demonstrate a good safety profile for daily administration of G-CSF when begun within 12 hours after onset of ischemic stroke and, in part in combination with routine i.v. thrombolysis. Additional analyses using VGM and a battery of neuropsychological tests indicated a positive functional and potentially structural effect of G-CSF treatment in some of our patients. TRIAL REGISTRATION: German Clinical Trial Register DRKS 00000723.

  8. Research of predictive factors for cardiac resynchronization therapy: a prospective study comparing data from phase-analysis of gated myocardial perfusion single-photon computed tomography and echocardiography : Trying to anticipate response to CRT.

    Science.gov (United States)

    Gendre, Rémy; Lairez, O; Mondoly, P; Duparc, A; Carrié, D; Galinier, M; Berry, I; Cognet, T

    2017-04-01

    Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in chronic systolic heart failure. About 20% of implanted patients are considered as "non-responders". This study aimed to evaluate gated myocardial perfusion single-photon emission computed tomography (GMPS) phase parameters as compared to echocardiography in the assessment of predictors for response to CRT before and after CRT activation. Forty-two patients were prospectively included during 15 months. A single injection of 99m Tc-tetrofosmin was used to acquire GMPS phase pre- and post-CRT activation. Indicators of positive CRT response were improvement of functional status and 15% reduction in left ventricular end-systolic volume at 3 months. Phase parameters at baseline were similar in the two groups with no influence of perfusion data. Phase parameters after CRT activation were significantly improved in the responders' group (Δ Bandwidth -19° ± 24° vs. 13° ± 31°, p = 0.001; Δ SD -20° ± 30° vs. 26° ± 46°, p = 0.001; Δ Entropy -11 ± 12 vs. 2 ± 6%, p = 0.001). Feasibility and reproducibility were higher for GMPS. Acute phase modifications after CRT activation may predict response to CRT immediately after implantation, but not at baseline, even when adjusted to perfusion data.

  9. Lipid bilayers: clusters, domains and phases.

    Science.gov (United States)

    Ackerman, David G; Feigenson, Gerald W

    2015-01-01

    In the present chapter we discuss the complex mixing behaviour of plasma membrane lipids. To do so, we first introduce the plasma membrane and membrane mixtures often used to model its complexity. We then discuss the nature of lipid phase behaviour in bilayers and the distinction between these phases and other manifestations of non-random mixing found in one-phase mixtures, such as clusters, micelles and microemulsions. Finally, we demonstrate the applicability of Gibbs phase diagrams to the study of increasingly complex model membrane systems, with a focus on phase coexistence, morphology and their implications for the cell plasma membrane.

  10. Assessment of the therapeutic benefit of dexamethasone cyclophosphamide pulse versus only oral cyclophosphamide in phase II of the dexamethasone cyclophosphamide pulse therapy: A preliminary prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    Nisha V Parmar

    2013-01-01

    Full Text Available Background: Dexamethasone cyclophosphamide pulse (DCP therapy is an established mode of treatment for pemphigus in India. Aims: To assess the therapeutic benefit of additional DCPs (phase II, consolidation phase versus immediate oral cyclophosphamide, usually used in phase III (maintenance phase, after initial DCP therapy (phase I and to assess which laboratory test (DIF or ELISA will reflect the clinical relapse best. Methods: Nineteen newly recruited patients of pemphigus vulgaris (PV received monthly DCPs in phase I and were then randomized into two groups. Group A (10 patients received monthly DCPs for nine months and Group B (nine patients received only oral cyclophosphamide for nine months. Direct immunofluorescence (DIF and enzyme-linked immunosorbent assay (ELISA were tested before starting DCP regimen, and at 0,3,6,9 months after randomization. Results: Clinical relapse by the end of follow-up period occurred in only one patient in each group. In these cases, DIF became (again positive before the relapse. No statistically significant difference between the two groups was found at three, six and nine months by ELISA indices and DIF grading. Conclusion: Although the DCP regimen is the standard therapy for pemphigus in India, we found no difference in the clinical outcome between patients receiving nine DCPs in phase II and patients shifted directly from phase I to III. Periodic testing using DIF and Dsg ELISA were found to be useful to monitor disease activity and predict a relapse. Further large scale studies are required to assess if patients can be shifted directly from phase I to III and maintained only on oral cyclophosphamide.

  11. Unusual linkage patterns of ligands and their cognate receptors indicate a novel reason for non-random gene order in the human genome

    Directory of Open Access Journals (Sweden)

    Lercher Martin J

    2005-11-01

    Full Text Available Abstract Background Prior to the sequencing of the human genome it was typically assumed that, tandem duplication aside, gene order is for the most part random. Numerous observers, however, highlighted instances in which a ligand was linked to one of its cognate receptors, with some authors suggesting that this may be a general and/or functionally important pattern, possibly associated with recombination modification between epistatically interacting loci. Here we ask whether ligands are more closely linked to their receptors than expected by chance. Results We find no evidence that ligands are linked to their receptors more closely than expected by chance. However, in the human genome there are approximately twice as many co-occurrences of ligand and receptor on the same human chromosome as expected by chance. Although a weak effect, the latter might be consistent with a past history of block duplication. Successful duplication of some ligands, we hypothesise, is more likely if the cognate receptor is duplicated at the same time, so ensuring appropriate titres of the two products. Conclusion While there is an excess of ligands and their receptors on the same human chromosome, this cannot be accounted for by classical models of non-random gene order, as the linkage of ligands/receptors is no closer than expected by chance. Alternative hypotheses for non-random gene order are hence worth considering.

  12. DOT or SAT for Rifampicin-resistant tuberculosis? A non-randomized comparison in a high HIV-prevalence setting.

    Science.gov (United States)

    Mohr, Erika; Daniels, Johnny; Beko, Busisiwe; Isaakidis, Petros; Cox, Vivian; Steele, Sarah Jane; Muller, Odelia; Snyman, Leigh; De Azevedo, Virginia; Shroufi, Amir; Trivino Duran, Laura; Hughes, Jennifer

    2017-01-01

    Daily directly-observed therapy (DOT) is recommended for rifampicin-resistant tuberculosis (RR-TB) patients throughout treatment. We assessed the impact of self-administered treatment (SAT) in a South African township with high rates of RR-TB and HIV. Community-supported SAT for patients who completed the intensive phase was piloted in five primary care clinics in Khayelitsha. We compared final treatment outcomes among RR-TB patients initiating treatment before (standard-of-care (SOC)-cohort, January 2010-July 2013) and after the implementation of the pilot (SAT-cohort, January 2012-December 2014). All patients with outcomes before January 1, 2017 were considered in the analysis of outcomes. One-hundred-eighteen patients in the SOC-cohort and 174 patients in the SAT-cohort had final RR-TB treatment outcomes; 70% and 73% were HIV-co-infected, respectively. The proportion of patients with a final outcome of loss to follow-up (LTFU) did not differ whether treated in the SOC (25/118, 21.2%) or SAT-cohort (31/174, 17.8%) (P = 0.47). There were no significant differences in the time to 24-month LTFU among HIV-infected and uninfected patients (HR 0.90, 95% CI: 0.51-1.6, P = 0.71), or among patients enrolled in the SOC-cohort versus the SAT-cohort (HR 0.83, 95% CI: 0.49-1.4, P = 0.50) who received at least 6-months of RR-TB treatment. The introduction of SAT during the continuation phase of RR-TB treatment does not adversely affect final RR-TB treatment outcomes in a high TB and HIV-burden setting. This differentiated, patient-centred model of care could be considered in RR-TB programmes to decrease the burden of DOT on patients and health facilities.

  13. Theoretical insights into kesterite and stannite phases of Cu2(Sn1–XGeXZnSe4 based alloys: A prospective photovoltaic material

    Directory of Open Access Journals (Sweden)

    S. Kumar

    2016-12-01

    Full Text Available A comparative study of kesterite (KS and stannite (ST phases of Cu2(Sn1−xGexZnSe4 (CTGZSe alloys has been carried out using a hybrid functional within the framework of density functional theory (DFT. Our calculations suggest that KS phase is energetically more stable. We find that the total energy of the KS phase decreases with increasing concentration (x of Ge. The calculated positive binding energies suggest that the alloy systems are stable. The formation enthalpy clearly indicates that CTGZSe alloys are thermodynamically stable and its growth can be achieved by following the route of an exothermic reaction. The calculated energy band gaps of the alloys agree well with the experimental data for the KS phase. The band offsets of KS and ST phases as a function of Ge concentration (x can be explained on the basis of the calculated energy band gaps. We find a slight upshift in the conduction band edges while the valence band edges remain almost the same on varying the concentration (x of Ge. Our results could be useful for the development of CTGZSe alloys based solar cells.

  14. A randomized phase III prospective trial of bethanechol to prevent mucositis, candidiasis, and taste loss in patients with head and neck cancer undergoing radiotherapy. A secondary analysis

    International Nuclear Information System (INIS)

    Jham, B.C.; Chen, H.; Carvalho, A.L.; Freire, A.R.

    2009-01-01

    The aim of this study was to determine the impact of bethanechol administration concomitant to radiotherapy (RT) on oral mucositis, candidiasis and taste loss. We performed a secondary analysis of a previously conducted prospective randomized trial which evaluated the effect of bethanechol on salivary gland dysfunction before, during, and after RT for head and neck cancer (HNC), in comparison to artificial saliva. Mucositis, candidiasis and taste loss were analyzed in 36 patients. Mucositis was scored using the World Health Organization (WHO) method; candidiasis was diagnosed by means of clinical examination, whereas taste loss was assessed by the patients' subjective report of absence of taste. No significant differences were observed between groups in relation to frequency and severity of mucositis or frequency of candidiasis and taste loss. In conclusion, bethanechol does not appear to reduce the incidence of mucositis, candidiasis, and taste loss when administered during RT. (author)

  15. Probability calculus of fractional order and fractional Taylor's series application to Fokker-Planck equation and information of non-random functions

    International Nuclear Information System (INIS)

    Jumarie, Guy

    2009-01-01

    A probability distribution of fractional (or fractal) order is defined by the measure μ{dx} = p(x)(dx) α , 0 α (D x α h α )f(x) provided by the modified Riemann Liouville definition, one can expand a probability calculus parallel to the standard one. A Fourier's transform of fractional order using the Mittag-Leffler function is introduced, together with its inversion formula; and it provides a suitable generalization of the characteristic function of fractal random variables. It appears that the state moments of fractional order are more especially relevant. The main properties of this fractional probability calculus are outlined, it is shown that it provides a sound approach to Fokker-Planck equation which are fractional in both space and time, and it provides new results in the information theory of non-random functions.

  16. Relation between oculo-auriculo-vertebral (OAV) dysplasia and three other non-random associations of malformations (VATER, CHARGE, and OEIS).

    Science.gov (United States)

    Källén, Karin; Robert, Elisabeth; Castilla, Eduardo E; Mastroiacovo, Pierpaolo; Källén, Bengt

    2004-05-15

    Using a statistical methodology, we aimed to identify a group of probable cases of oculo-auriculo-vertebral (OAV) dysplasia and to investigate possible relationships between different patterns of congenital malformations. Among 5,260 infants with multiple malformations collected from 4 large registers of congenital malformations, we identified 312 probable OAV cases. With the same technique, we have earlier defined epidemiological delineations of three other well-known non-random associations of congenital malformations (CHARGE, VATER, and OEIS). We found convincing relationships between OAV and VATER or CHARGE but none between OAV and OEIS or between the three malformation complexes CHARGE, VATER, and OEIS. An association between two conditions indicates similarities in pathogenesis or in etiology. We suggest that the connection between OAV and CHARGE could be related to a common pathogenetic mechanism: disturbed neural crest development. Copyright 2003 Wiley-Liss, Inc.

  17. A 12-Month Prospective, Observational Study of Treatment Regimen and Quality of Life Associated with ADHD in Central and Eastern Europe and Eastern Asia

    Science.gov (United States)

    Goetz, Michal; Yeh, Chin-Bin; Ondrejka, Igor; Akay, Aynur; Herczeg, Ilona; Dobrescu, Iuliana; Kim, Boong Nyun; Jin, Xingming; Riley, Anne W.; Martenyi, Ferenc; Harrison, Gavan; Treuer, Tamas

    2012-01-01

    Objectives: This prospective, observational, non-randomized study aimed to describe the relationship between treatment regimen prescribed and the quality of life (QoL) of ADHD patients in countries of Central and Eastern Europe (CEE) and Eastern Asia over 12 months. Methods: 977 Male and female patients aged 6-17 years seeking treatment for…

  18. Rivaroxaban in antiphospholipid syndrome (RAPS) protocol: a prospective, randomized controlled phase II/III clinical trial of rivaroxaban versus warfarin in patients with thrombotic antiphospholipid syndrome, with or without SLE.

    Science.gov (United States)

    Cohen, H; Doré, C J; Clawson, S; Hunt, B J; Isenberg, D; Khamashta, M; Muirhead, N

    2015-09-01

    The current mainstay of the treatment of thrombotic antiphospholipid syndrome (APS) is long-term anticoagulation with vitamin K antagonists (VKAs) such as warfarin. Non-VKA oral anticoagulants (NOACs), which include rivaroxaban, have been shown to be effective and safe compared with warfarin for the treatment of venous thromboembolism (VTE) in major phase III prospective, randomized controlled trials (RCTs), but the results may not be directly generalizable to patients with APS. The primary aim is to demonstrate, in patients with APS and previous VTE, with or without systemic lupus erythematosus (SLE), that the intensity of anticoagulation achieved with rivaroxaban is not inferior to that of warfarin. Secondary aims are to compare rates of recurrent thrombosis, bleeding and the quality of life in patients on rivaroxaban with those on warfarin. Rivaroxaban in antiphospholipid syndrome (RAPS) is a phase II/III prospective non-inferiority RCT in which eligible patients with APS, with or without SLE, who are on warfarin, target international normalized ratio (INR) 2.5 for previous VTE, will be randomized either to continue warfarin (standard of care) or to switch to rivaroxaban. Intensity of anticoagulation will be assessed using thrombin generation (TG) testing, with the primary outcome the percentage change in endogenous thrombin potential (ETP) from randomization to day 42. Other TG parameters, markers of in vivo coagulation activation, prothrombin fragment 1.2, thrombin antithrombin complex and D-dimer, will also be assessed. If RAPS demonstrates i) that the anticoagulant effect of rivaroxaban is not inferior to that of warfarin and ii) the absence of any adverse effects that cause concern with regard to the use of rivaroxaban, this would provide sufficient supporting evidence to make rivaroxaban a standard of care for the treatment of APS patients with previous VTE, requiring a target INR of 2.5. © The Author(s) 2015.

  19. Hepatic and vascular enhancement at dual-phase helical CT: comparison of Iobitridol 300 and Iohexol 300 in a prospective randomized study

    International Nuclear Information System (INIS)

    Legmann, P.; Vignaux, O.; Bahurel, H.; Oudjit, A.; Coste, J.

    2001-01-01

    The purpose of this study was to determine hepatic and vascular enhancement, clinical tolerance, and iconographic quality of Iobitridol (300 mg/ml) at dual-phase helical CT and to compare it with Iohexol (300 mg/ml). One hundred forty-six patients were randomly divided into two groups. Each group received 120 ml of Iohexol (group A) or Iobitridol (group B). Mean enhancement of liver, aorta and portal vein was obtained at the arterial phase and at the portal-venous phase. Overall image quality was assessed by two independent blinded investigators. Adverse reactions were recorded. There were no significant differences in demographic characteristics and distribution of patient intrinsic parameters between the two groups, except for blood pressure but without statistical correlation between the difference in blood pressure and the impact on enhancement measurements. There was no significant difference in clinical tolerance and image quality. Mean liver as well as aortic and portal vein enhancement measurements did not show any significant difference. Iobitridol compares favorably with Iohexol. Both products have similar safety, tolerance, and efficacy. Both contrast media have equivalent blood pool concentration and interstitial compartment diffusion. (orig.)

  20. Evaluating the Effectiveness of an Antimicrobial Stewardship Program on Reducing the Incidence Rate of Healthcare-Associated Clostridium difficile Infection: A Non-Randomized, Stepped Wedge, Single-Site, Observational Study.

    Directory of Open Access Journals (Sweden)

    Giulio DiDiodato

    Full Text Available The incidence rate of healthcare-associated Clostridium difficile infection (HA-CDI is estimated at 1 in 100 patients. Antibiotic exposure is the most consistently reported risk factor for HA-CDI. Strategies to reduce the risk of HA-CDI have focused on reducing antibiotic utilization. Prospective audit and feedback is a commonly used antimicrobial stewardship intervention (ASi. The impact of this ASi on risk of HA-CDI is equivocal. This study examines the effectiveness of a prospective audit and feedback ASi on reducing the risk of HA-CDI.Single-site, 339 bed community-hospital in Barrie, Ontario, Canada. Primary outcome is HA-CDI incidence rate. Daily prospective and audit ASi is the exposure variable. ASi implemented across 6 wards in a non-randomized, stepped wedge design. Criteria for ASi; any intravenous antibiotic use for ≥ 48 hrs, any oral fluoroquinolone or oral second generation cephalosporin use for ≥ 48 hrs, or any antimicrobial use for ≥ 5 days. HA-CDI cases and model covariates were aggregated by ward, year and month starting September 2008 and ending February 2016. Multi-level mixed effect negative binomial regression analysis was used to model the primary outcome, with intercept and slope coefficients for ward-level random effects estimated. Other covariates tested for inclusion in the final model were derived from previously published risk factors. Deviance residuals were used to assess the model's goodness-of-fit.The dataset included 486 observation periods, of which 350 were control periods and 136 were intervention periods. After accounting for all other model covariates, the estimated overall ASi incidence rate ratio (IRR was 0.48 (95% 0.30, 0.79. The ASi effect was independent of antimicrobial utilization. The ASi did not seem to reduce the risk of Clostridium difficile infection on the surgery wards (IRR 0.87, 95% CI 0.45, 1.69 compared to the medicine wards (IRR 0.42, 95% CI 0.28, 0.63. The ward-level burden of

  1. Low-Dose Total Skin Electron Beam Therapy as a Debulking Agent for Cutaneous T-Cell Lymphoma: An open-label prospective phase II study

    DEFF Research Database (Denmark)

    Kamstrup, M R; Lindahl, Lise Maria; Gniadecki, R

    2012-01-01

    Background: Total skin electron beam therapy (TSEBT) is a powerful treatment for cutaneous T-cell lymphomas (CTCL). Based on the occurrence of relapses with low radiation doses, doses of 30-36 Gy are commonly used but most patients still eventually relapse and repeat treatment courses are limited...... due to the cumulative toxicity. Complete response rates are about 60-90% for T2-4 stages with a 5-year relapse-free survival of 10-25% for stages IB-III. Objectives: To evaluate prospectively the efficacy of low-dose TSEBT (10 Gy) in terms of complete cutaneous response rate, overall response rate...... and response duration in CTCL. Methods: Ten patients with stage IB-IV mycosis fungoides (MF) were treated in an open-label manner with 4 fractions of 1 Gy/week TSEB to a total skin dose of 10 Gy. Treatment responses were assessed at 1 and 3 months after treatment and subsequently at least every 6 months...

  2. Phase IV prospective clinical study to evaluate the effect of taurine on liver function in postsurgical adult patients requiring parenteral nutrition.

    Science.gov (United States)

    Arrieta, Francisco; Balsa, José Antonio; de la Puerta, Cristina; Botella, José Ignacio; Zamarrón, Isabel; Elías, Elena; Del Río, José Ignacio Pérez; Alonso, Paloma; Candela, Angel; Blanco-Colio, Luis Miguel; Egido, Jesús; Navarro, Pilar; Vázquez, Clotilde

    2014-10-01

    Taurine's role in bile acid metabolism and anti-inflammatory activity could exert a protective effect on hepatobiliary complications associated with parenteral nutrition (PN). In this study, the effects of 2 amino acid solutions, with and without taurine, on liver function administered to nonacutely ill postsurgical patients as part of a short-term PN regimen were prospectively compared. Adult patients randomly received (double-blind) Tauramin 10% or a standard PN solution without taurine as the control (1.5 g amino acid/kg body weight [bw]/d; infusion rate of ≤4 mg glucose/kg bw/d) for a period of 5-30 days. γ-Glutamyl transpeptidase (GGT) and other indicators of liver function, glucose metabolism, lipid profile, inflammation markers, and treatment safety data were collected. Thirty-five patients receiving taurine PN and 39 receiving control PN were enrolled (intention-to-treat [ITT] population). Most patients (n = 62) discontinued after day 7 of follow-up (per-protocol [PP] population: n = 24 and n = 27, respectively). ITT patients with high GGT values after 5 days of PN comprised 68.6% and 64.1%, respectively. The mean change in GGT values with respect to the baseline values was 167 ± 192 and 157 ± 185 IU/L, respectively. Low-density lipoprotein (LDL) cholesterol levels after 7 days of PN were significantly decreased in the taurine PN group of PP patients (-2.83 ± 30.9 vs 23.9 ± 27.0 mg/dL for control PN; P taurine PN: n = 6; control PN: n = 7) were treatment related. PN solutions with and without taurine had similar effects on liver function parameters, except for an LDL reduction in PN with taurine, when administered to nonacutely ill postsurgical patients in the short term (5-7 days). © 2014 American Society for Parenteral and Enteral Nutrition.

  3. Influence of Proton and Salt Concentration on the Chromonic Liquid Crystal Phase Diagram of Disodium Cromoglycate Solutions: Prospects and Limitations of a Host for DNA Nanostructures.

    Science.gov (United States)

    Zhang, Bingru; Kitzerow, Heinz-S

    2016-03-31

    Lyotropic chromonic liquid crystals have recently been suggested for use as a self-organized host for dispersing and aligning self-organized DNA origami nanostructures. However, an appropriate pH value and a suitable cation concentration are necessary to stabilize such nanostructures and to avoid unfolding of the DNA. The present study shows that the nematic and columnar liquid crystal phases appearing in aqueous solutions of disodium cromoglycate are robust against the replacement of deionized water by a neutral or alkaline buffer solution. However, disodium cromoglycate precipitates when an acidic buffer is used or when the concentration of magnesium cations exceeds a critical concentration of about 0.6-0.7 mmol/L.

  4. Predictive factors of survival after thalidomide therapy in advanced multiple myeloma: long-term follow-up of a prospective multicenter nonrandomized phase II study in 120 patients.

    Science.gov (United States)

    Decaux, Olivier; Renault, Alain; Sébille, Véronique; Moreau, Philippe; Attal, Michel; Voillat, Laurent; Pegourie, Brigitte; Tiab, Mourad; Facon, Thierry; Zerbib, Robert; Grosbois, Bernard; Bellissant, Eric

    2012-12-01

    Thalidomide monotherapy has demonstrated consistent results in the treatment of advanced multiple myeloma. We report a 9-year follow-up of a French multicenter nonrandomized phase II study that evaluated the effect of oral thalidomide in 120 patients with advanced multiple myeloma. Independent predictors of survival were response to last therapy, performance status, serum β(2)-microglobulin level, platelet count, and response at day 60 of treatment. Thalidomide monotherapy has demonstrated consistent results in the treatment of advanced multiple myeloma. We report the 9-year follow-up of a French multicenter, nonrandomized, phase II study that evaluated the effect of oral thalidomide in advanced multiple myeloma. Thalidomide was started at 200 mg/d and increased to 400 mg/d at day 15. One hundred twenty patients were enrolled in 2 months at 33 centers. The overall response rate was 31.7% (38/120) on day 60. Overall survival rates were 47.5% (95% confidence interval [CI], 38.6-56.4), 25.0% (95% CI, 17.3-32.7), 11.7% (95% CI, 5.9-17.4), and 7.5% (95% CI, 2.8-12.2) at 1, 3, 6, and 9 years, respectively. Independent predictors of short survival at 1, 3, 6, and 9 years were multiple myeloma refractory to last therapy, performance status ≥ 2, serum β(2)-microglobulin level ≥ 3.5 mg/L, platelet count < 152 × 10(9)/L, and nonresponse at day 60 (Cox proportional hazards regression model). Our study identified 5 independent unfavorable prognostic factors associated with short survival. These prognostic factors were very robust, allowing the prediction of patient survival not only during the first year but also during 3, 6, and even 9 years after the beginning of treatment. Copyright © 2012 Elsevier Inc. All rights reserved.

  5. Intraoperative stereotactic injection of Indigo Carmine dye to mark ill-defined tumor margins: a prospective phase I-II study.

    Science.gov (United States)

    Margetis, Konstantinos; Rajappa, Prajwal; Tsiouris, Apostolos John; Greenfield, Jeffrey P; Schwartz, Theodore H

    2015-01-01

    A critical goal in neurosurgical oncology is maximizing the extent of tumor resection while minimizing the risk to normal white matter tracts. Frameless stereotaxy and white matter mapping are indispensable tools in this effort, but deep tumor margins may not be accurately defined because of the "brain shift" at the end of the operation. The authors investigated the safety and efficacy of a technique for marking the deep margins of intraaxial tumors with stereotactic injection of Indigo Carmine dye. Investigational New Drug study approval for a prospective study in adult patients with gliomas was obtained from the FDA (Investigational New Drug no. 112680). At surgery, 1-3 stereotactic injections of 0.01 ml of Indigo Carmine dye were performed through the initial bur holes into the deep tumor margins before elevation of the bone flap. White light microscopic resection was conducted in standard fashion by using frameless stereotactic navigation until the injected margins were identified. The resection of the injected tumor margins and the extent of resection of the whole tumor volume were determined by using postoperative volumetric MRI. In total 17 injections were performed in 10 enrolled patients (6 male, 4 female), whose mean age was 49 years. For all patients, the injection points were identified intraoperatively and tumor was resected at these points. The staining pattern was reproducible; it was a sphere of stained tissue approximately 5 mm in diameter. A halo of stained tissue and a backflow of dye through the needle tract were also noted, but these were clearly distinct from the staining pattern of the injection point, which was vividly colored and demarcated. Postoperative MR images verified the resection of all injection points. The mean extent of resection of the tumor as a whole was 97.1%. For 1 patient, a brain abscess developed on postoperative Day 16 and needed additional surgical treatment. Stereotactic injection of Indigo Carmine dye can be used to

  6. The Short Breath-Hold Technique, Controlled Aliasing in Parallel Imaging Results in Higher Acceleration, Can Be the First Step to Overcoming a Degraded Hepatic Arterial Phase in Liver Magnetic Resonance Imaging: A Prospective Randomized Control Study.

    Science.gov (United States)

    Yoo, Jung Lim; Lee, Chang Hee; Park, Yang Shin; Kim, Jeong Woo; Lee, Jongmee; Kim, Kyeong Ah; Seol, Hae Young; Park, Cheol Min

    2016-07-01

    The aim of this study was to assess whether a short breath-hold technique can improve hepatic arterial phase (HAP) image quality in gadoxetic acid-enhanced magnetic resonance (MR) imaging compared with a conventional long breath-hold technique. Institutional review board approval and patient consent were obtained for this prospective randomized control study. One hundred nineteen patients undergoing gadoxetic acid-enhanced MR imaging were randomly assigned to groups A or B. Group A patients underwent an 18-second long breath-hold MR technique (conventional VIBE [volumetric interpolated breath-hold examination] technique with GRAPPA [generalized autocalibrating partially parallel acquisition]), and group B patients underwent a 13-second short breath-hold MR technique (VIBE technique with CAIPIRINHA [controlled aliasing in parallel imaging results in higher acceleration]). Respiratory-related graphs of the precontrast and HAP were acquired. The breath-hold degree was graded based on the standard deviation (SD) value of respiratory waveforms. Gadoxetic acid-related dyspnea was defined as when the SD value of the HAP was 200 greater than that of the precontrast phase without degraded image quality in the portal and transitional phases (SD value of the HAP - SD value of the precontrast phase). The overall image quality and motion artifacts of the precontrast and HAP images were evaluated. The groups were compared using the Student t or Fisher exact test, as appropriate. The incidence of breath-holding difficulty (breath-hold grades 3 and 4) during the HAP was 43.6% (27/62) and 36.8% (21/57) for group A and B, respectively. The SD value during the precontrast phase and the SD value difference between the precontrast and HAP were both significantly higher in group A than in group B (P = 0.047 and P = 0.023, respectively). Gadoxetic acid-related dyspnea was seen in 19.4% (12/62) of group A and 7.0% (4/57) of group B. Group B showed better precontrast and HAP image quality

  7. A Novel Form of Breast Intraoperative Radiation Therapy With CT-Guided High-Dose-Rate Brachytherapy: Results of a Prospective Phase 1 Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Showalter, Shayna L., E-mail: snl2t@virginia.edu [Division of Surgical Oncology, Department of Surgery, University of Virginia School of Medicine, Charlottesville, Virginia (United States); Petroni, Gina [Division of Translation Research and Applied Statistics, Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia (United States); Trifiletti, Daniel M.; Libby, Bruce [Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia (United States); Schroen, Anneke T.; Brenin, David R. [Division of Surgical Oncology, Department of Surgery, University of Virginia School of Medicine, Charlottesville, Virginia (United States); Dalal, Parchayi [Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia (United States); Smolkin, Mark [Division of Translation Research and Applied Statistics, Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia (United States); Reardon, Kelli A.; Showalter, Timothy N. [Department of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia (United States)

    2016-09-01

    Purpose: Existing intraoperative radiation therapy (IORT) techniques are criticized for the lack of image guided treatment planning and energy deposition with, at times, poor resultant dosimetry and low radiation dose. We pioneered a novel method of IORT that incorporates customized, computed tomography (CT)-based treatment planning and high-dose-rate (HDR) brachytherapy to overcome these drawbacks: CT-HDR-IORT. Methods and Materials: A phase 1 study was conducted to demonstrate the feasibility and safety of CT-HDR-IORT. Eligibility criteria included age ≥50 years, invasive or in situ breast cancer, tumor size <3 cm, and N0 disease. Patients were eligible before or within 30 days of breast-conserving surgery (BCS). BCS was performed, and a multilumen balloon catheter was placed. CT images were obtained, a customized HDR brachytherapy plan was created, and a dose of 12.5 Gy was delivered to 1-cm depth from the balloon surface. The catheter was removed, and the skin was closed. The primary endpoints were feasibility and acute toxicity. Feasibility was defined as IORT treatment interval (time from CT acquisition until IORT completion) ≤90 minutes. The secondary endpoints included dosimetry, cosmetic outcome, quality of life, and late toxicity. Results: Twenty-eight patients were enrolled. The 6-month follow-up assessments were completed by 93% of enrollees. The median IORT treatment interval was 67.2 minutes (range, 50-108 minutes). The treatment met feasibility criteria in 26 women (93%). The dosimetric goals were met in 22 patients (79%). There were no Radiation Therapy Oncology Group grade 3+ toxicities; 6 patients (21%) experienced grade 2 events. Most patients (93%) had good/excellent cosmetic outcomes at the last follow-up visit. Conclusions: CT-HDR-IORT is feasible and safe. This promising approach for a conformal, image-based, higher-dose breast IORT is being evaluated in a phase 2 trial.

  8. Dose-Reduced Versus Standard Conditioning Followed by Allogeneic Stem-Cell Transplantation for Patients With Myelodysplastic Syndrome: A Prospective Randomized Phase III Study of the EBMT (RICMAC Trial).

    Science.gov (United States)

    Kröger, Nicolaus; Iacobelli, Simona; Franke, Georg-Nikolaus; Platzbecker, Uwe; Uddin, Ruzena; Hübel, Kai; Scheid, Christof; Weber, Thomas; Robin, Marie; Stelljes, Matthias; Afanasyev, Boris; Heim, Dominik; Deliliers, Giorgio Lambertenghi; Onida, Francesco; Dreger, Peter; Pini, Massimo; Guidi, Stefano; Volin, Liisa; Günther, Andreas; Bethge, Wolfgang; Poiré, Xavier; Kobbe, Guido; van Os, Marleen; Brand, Ronald; de Witte, Theo

    2017-07-01

    Purpose To compare a reduced-intensity conditioning regimen (RIC) with a myeloablative conditioning regimen (MAC) before allogeneic transplantation in patients with myelodysplastic syndrome (MDS) within a randomized trial. Patients and Methods Within the European Society of Blood and Marrow Transplantation, we conducted a prospective, multicenter, open-label, randomized phase III trial that compared a busulfan-based RIC with MAC in patients with MDS or secondary acute myeloid leukemia. A total of 129 patients were enrolled from 18 centers. Patients were randomly assigned in a 1:1 ratio and were stratified according to donor, age, and blast count. Results Engraftment was comparable between both groups. The CI of acute graft-versus-host disease II to IV was 32.3% after RIC and 37.5% after MAC ( P = .35). The CI of chronic graft-versus-host disease was 61.6% after RIC and 64.7% after MAC ( P = .76). The CI of nonrelapse mortality after 1 year was 17% (95% CI, 8% to 26%) after RIC and 25% (95% CI, 15% to 36%) after MAC ( P = .29). The CI of relapse at 2 years was 17% (95% CI, 8% to 26%) after RIC and 15% (95% CI, 6% to 24%) after MAC ( P = .6), which resulted in a 2-year relapse-free survival and overall survival of 62% (95% CI, 50% to 74%) and 76% (95% CI, 66% to 87%), respectively, after RIC, and 58% (95% CI, 46% to 71%) and 63% (95% CI, 51% to 75%), respectively, after MAC ( P = .58 and P = .08, respectively). Conclusion This prospective, randomized trial of the European Society of Blood and Marrow Transplantation provides evidence that RIC resulted in at least a 2-year relapse-free survival and overall survival similar to MAC in patients with MDS or secondary acute myeloid leukemia.

  9. Estimating the treatment effect from non-randomized studies: The example of reduced intensity conditioning allogeneic stem cell transplantation in hematological diseases

    Directory of Open Access Journals (Sweden)

    Resche-Rigon Matthieu

    2012-08-01

    Full Text Available Abstract Background In some clinical situations, for which RCT are rare or impossible, the majority of the evidence comes from observational studies, but standard estimations could be biased because they ignore covariates that confound treatment decisions and outcomes. Methods Three observational studies were conducted to assess the benefit of Allo-SCT in hematological malignancies of multiple myeloma, follicular lymphoma and Hodgkin’s disease. Two statistical analyses were performed: the propensity score (PS matching approach and the inverse probability weighting (IPW approach. Results Based on PS-matched samples, a survival benefit in MM patients treated by Allo-SCT, as compared to similar non-allo treated patients, was observed with an HR of death at 0.35 (95%CI: 0.14-0.88. Similar results were observed in HD, 0.23 (0.07-0.80 but not in FL, 1.28 (0.43-3.77. Estimated benefits of Allo-SCT for the original population using IPW were erased in HR for death at 0.72 (0.37-1.39 for MM patients, 0.60 (0.19-1.89 for HD patients, and 2.02 (0.88-4.66 for FL patients. Conclusion Differences in estimated benefits rely on whether the underlying population to which they apply is an ideal randomized experimental population (PS or the original population (IPW. These useful methods should be employed when assessing the effects of innovative treatment in non-randomized experiments.

  10. Feasibility and effectiveness of a combined individual and psychoeducational group intervention in psychiatric residential facilities: A controlled, non-randomized study.

    Science.gov (United States)

    Magliano, Lorenza; Puviani, Marta; Rega, Sonia; Marchesini, Nadia; Rossetti, Marisa; Starace, Fabrizio

    2016-01-30

    This controlled, non-randomized study explored the feasibility of introducing a Combined Individual and Group Intervention (CIGI) for users with mental disorders in residential facilities, and tested whether users who received the CIGI had better functioning than users who received the Treatment-As-Usual (TAU), at two-year follow up. In the CIGI, a structured cognitivebehavioral approach called VADO (in English, Skills Assessment and Definition of Goals) was used to set specific goals with each user, while Falloon's psychoeducational treatment was applied with the users as a group. Thirty-one professionals attended a training course in CIGI, open to users' voluntary participation, and applied it for two years with all users living in 8 residential facilities of the Mental Health Department of Modena, Italy. In the same department, 5 other residential facilities providing TAU were used as controls. ANOVA for repeated measures showed a significant interaction effect between users' functioning at baseline and follow up assessments, and the intervention. In particular, change in global functioning was higher in the 55 CIGI users than in the 44 TAU users. These results suggest that CIGI can be successfully introduced in residential facilities and may be useful to improve functioning in users with severe mental disorders. Copyright © 2016. Published by Elsevier Ireland Ltd.

  11. Pre-hospital electrocardiogram triage with telemedicine near halves time to treatment in STEMI: A meta-analysis and meta-regression analysis of non-randomized studies.

    Science.gov (United States)

    Brunetti, Natale Daniele; De Gennaro, Luisa; Correale, Michele; Santoro, Francesco; Caldarola, Pasquale; Gaglione, Antonio; Di Biase, Matteo

    2017-04-01

    A shorter time to treatment has been shown to be associated with lower mortality rates in acute myocardial infarction (AMI). Several strategies have been adopted with the aim to reduce any delay in diagnosis of AMI: pre-hospital triage with telemedicine is one of such strategies. We therefore aimed to measure the real effect of pre-hospital triage with telemedicine in case of AMI in a meta-analysis study. We performed a meta-analysis of non-randomized studies with the aim to quantify the exact reduction of time to treatment achieved by pre-hospital triage with telemedicine. Data were pooled and compared by relative time reduction and 95% C.I.s. A meta-regression analysis was performed in order to find possible predictors of shorter time to treatment. Eleven studies were selected and finally evaluated in the study. The overall relative reduction of time to treatment with pre-hospital triage and telemedicine was -38/-40% (pPre-hospital triage with telemedicine is associated with a near halved time to treatment in AMI. The benefit is larger in terms of absolute time to treatment reduction in populations with larger delays to treatment. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. Bifidobacterium bifidum OLB6378 Simultaneously Enhances Systemic and Mucosal Humoral Immunity in Low Birth Weight Infants: A Non-Randomized Study

    Directory of Open Access Journals (Sweden)

    Katsunori Tanaka

    2017-02-01

    Full Text Available Probiotic supplementation has been part of the discussion on methods to enhance humoral immunity. Administration of Bifidobacterium bifidum OLB6378 (OLB6378 reduced the incidence of late-onset sepsis in infants. In this non-randomized study, we aimed to determine the effect of administration of live OLB6378 on infants’ humoral immunity. Secondly, we tried to elucidate whether similar effects would be observed with administration of non-live OLB6378. Low birth weight (LBW infants weighing 1500–2500 g were divided into three groups: Group N (no intervention, Group L (administered live OLB6378 concentrate, and Group H (administered non-live OLB6378 concentrate. The interventions were started within 48 h after birth and continued until six months of age. Serum immunoglobulin G (IgG levels (IgG at one month/IgG at birth were significantly higher in Group L than in Group N (p < 0.01. Group H exhibited significantly higher serum IgG levels (p < 0.01 at one month of age and significantly higher intestinal secretory immunoglobulin A (SIgA levels (p < 0.05 at one and two months of age than Group N. No difference was observed in the mortality or morbidity between groups. Thus, OLB6378 administration in LBW infants enhanced humoral immunity, and non-live OLB6378, which is more useful as a food ingredient, showed a more marked effect than the viable bacteria.

  13. Single-stage endoscopic treatment for mild to moderate acute cholangitis associated with choledocholithiasis: a multicenter, non-randomized, open-label and exploratory clinical trial.

    Science.gov (United States)

    Eto, Kazunori; Kawakami, Hiroshi; Haba, Shin; Yamato, Hiroaki; Okuda, Toshinori; Yane, Kei; Hayashi, Tsuyoshi; Ehira, Nobuyuki; Onodera, Manabu; Matsumoto, Ryusuke; Matsubara, Yu; Takagi, Tomofumi; Sakamoto, Naoya

    2015-12-01

    Two-stage treatment involving stone removal after drainage is recommended for mild to moderate acute cholangitis associated with choledocholithiasis. However, single-stage treatment has some advantages. We aimed to assess the efficacy and safety of single-stage endoscopic treatment for mild to moderate acute cholangitis associated with choledocholithiasis. A multicenter, non-randomized, open-label, exploratory clinical trial was performed in 12 institutions. A total of 50 patients with a naïve papilla and a body temperature ≥37 °C who were diagnosed with mild to moderate cholangitis associated with choledocholithiasis were enrolled between August 2012 and February 2014. Of the 50 patients, 15 had mild cholangitis and 35 had moderate cholangitis. The median number of common bile duct stones was 2 (range, 1-8), and the median diameter of the common bile duct stones was 7.5 mm (range, 1-18). The cure rate of acute cholangitis within 4 days after single-stage treatment was 90% (45/50) based on a body temperature choledocholithiasis (clinical trial registration number: UMIN000008494). © 2015 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

  14. An Ant Colony Optimization algorithm for solving the fixed destination multi-depot multiple traveling salesman problem with non-random parameters

    Science.gov (United States)

    Ramadhani, T.; Hertono, G. F.; Handari, B. D.

    2017-07-01

    The Multiple Traveling Salesman Problem (MTSP) is the extension of the Traveling Salesman Problem (TSP) in which the shortest routes of m salesmen all of which start and finish in a single city (depot) will be determined. If there is more than one depot and salesmen start from and return to the same depot, then the problem is called Fixed Destination Multi-depot Multiple Traveling Salesman Problem (MMTSP). In this paper, MMTSP will be solved using the Ant Colony Optimization (ACO) algorithm. ACO is a metaheuristic optimization algorithm which is derived from the behavior of ants in finding the shortest route(s) from the anthill to a form of nourishment. In solving the MMTSP, the algorithm is observed with respect to different chosen cities as depots and non-randomly three parameters of MMTSP: m, K, L, those represents the number of salesmen, the fewest cities that must be visited by a salesman, and the most number of cities that can be visited by a salesman, respectively. The implementation is observed with four dataset from TSPLIB. The results show that the different chosen cities as depots and the three parameters of MMTSP, in which m is the most important parameter, affect the solution.

  15. Does implementing a development plan for user participation in a mental hospital change patients' experience? A non-randomized controlled study.

    Science.gov (United States)

    Rise, Marit B; Steinsbekk, Aslak

    2015-10-01

    Governments in several countries attempt to strengthen user participation through instructing health-care organizations to implement user participation initiatives. There is, however, little knowledge on the effect on patients' experience from comprehensive plans for enhancing user participation in whole health service organizations. To investigate whether implementing a development plan intending to enhance user participation in a mental hospital had any effect on the patients' experience of user participation. A non-randomized controlled study including patients in three mental hospitals in Central Norway, one intervention hospital and two control hospitals. A development plan intended to enhance user participation was implemented in the intervention hospital as a part of a larger reorganizational process. The plan included establishment of a patient education centre and a user office, purchase of user expertise, appointment of contact professionals for next of kin and improvement of the centre's information and the professional culture. Perceptions of Care, Inpatient Treatment Alliance Scale and questions made for this study. A total of 1651 patients participated. Implementing a development plan in a mental hospital intending to enhance user participation had no significant effect on the patients' experience of user participation. The lack of effect can be due to inappropriate initiatives or challenges in implementation processes. Further research should ensure that initiatives and implementation processes are appropriate to impact the patients' experience. © 2013 John Wiley & Sons Ltd.

  16. Development, feasibility, and efficacy of a customized exercise device to deliver intradialytic resistance training in patients with end stage renal disease: Non-randomized controlled crossover trial.

    Science.gov (United States)

    Chan, Danwin; Green, Simon; Fiatarone Singh, Maria; Barnard, Robert; Cheema, Birinder S

    2016-10-01

    Introduction This study assessed the feasibility and efficacy of a novel resistance training device used within an intradialytic progressive resistance training (PRT) intervention. Methods Non-randomized, within-subjects crossover design with outcomes assessed at baseline (week 0), postcontrol (week 13) and post-PRT intervention (week 26). Twenty-two hemodialysis patients (59% men, 71 ± 11 years) performed PRT three sessions per week for 12 weeks. The resistance training device was developed to enable the performance of 2 upper body and 3 lower body exercises, unilaterally and bilaterally, both before and during dialysis, with loads of 2.5 to 59 kg. Feasibility outcomes included adverse events, adherence and training load progression. Changes in upper and lower body muscular strength, six-minute walk, aspects of health-related quality of life (HRQoL) and depression were evaluated. Findings The PRT intervention was delivered without serious adverse events, resulted in 71.2% ± 23.3% adherence and significant adaptation of all training loads from pre to mid to post training (83.8%-185.6%, all P Emotional) significantly increased (all P outcomes. Discussion PRT using the novel resistance training device was feasible and improved measures of physical and psychological health. This device can be utilized in most dialysis centers. Future studies are required to evaluate dose-response effects of PRT prescriptions in subpopulations, and the translation of PRT to standard dialysis practice. © 2016 International Society for Hemodialysis.

  17. Links between fear of humans, stress and survival support a non-random distribution of birds among urban and rural habitats.

    Science.gov (United States)

    Rebolo-Ifrán, Natalia; Carrete, Martina; Sanz-Aguilar, Ana; Rodríguez-Martínez, Sol; Cabezas, Sonia; Marchant, Tracy A; Bortolotti, Gary R; Tella, José L

    2015-09-08

    Urban endocrine ecology aims to understand how organisms cope with new sources of stress and maintain allostatic load to thrive in an increasingly urbanized world. Recent research efforts have yielded controversial results based on short-term measures of stress, without exploring its fitness effects. We measured feather corticosterone (CORTf, reflecting the duration and amplitude of glucocorticoid secretion over several weeks) and subsequent annual survival in urban and rural burrowing owls. This species shows high individual consistency in fear of humans (i.e., flight initiation distance, FID), allowing us to hypothesize that individuals distribute among habitats according to their tolerance to human disturbance. FIDs were shorter in urban than in rural birds, but CORTf levels did not differ, nor were correlated to FIDs. Survival was twice as high in urban as in rural birds and links with CORTf varied between habitats: while a quadratic relationship supports stabilizing selection in urban birds, high predation rates may have masked CORTf-survival relationship in rural ones. These results evidence that urban life does not constitute an additional source of stress for urban individuals, as shown by their near identical CORTf values compared with rural conspecifics supporting the non-random distribution of individuals among habitats according to their behavioural phenotypes.

  18. Non-randomized therapy trial to determine the safety and efficacy of heavy ion radiotherapy in patients with non-resectable osteosarcoma

    Directory of Open Access Journals (Sweden)

    Bischof Marc

    2010-03-01

    Full Text Available Abstract Background Osteosarcoma is the most common primary malignant bone tumor in children and adolescents. For effective treatment, local control of the tumor is absolutely critical, because the chances of long term survival are EURAMOS1. Local photon radiotherapy has previously been used in small series and in an uncontrolled, highly individualized fashion, which, however, documented that high dose radiotherapy can, in principle, be used to achieve local control. Generally the radiation dose that is necessary for a curative approach can hardly be achieved with conventional photon radiotherapy in patients with non-resectable tumors that are usually located near radiosensitive critical organs such as the brain, the spine or the pelvis. In these cases particle Radiotherapy (proton therapy (PT/heavy ion therapy (HIT may offer a promising new alternative. Moreover, compared with photons, heavy ion beams provide a higher physical selectivity because of their finite depth coverage in tissue. They achieve a higher relative biological effectiveness. Phase I/II dose escalation studies of HIT in adults with non-resectable bone and soft tissue sarcomas have already shown favorable results. Methods/Design This is a monocenter, single-arm study for patients ≥ 6 years of age with non-resectable osteosarcoma. Desired target dose is 60-66 Cobalt Gray Equivalent (Gy E with 45 Gy PT (proton therapy and a carbon ion boost of 15-21 GyE. Weekly fractionation of 5-6 × 3 Gy E is used. PT/HIT will be administered exclusively at the Ion Radiotherapy Center in Heidelberg. Furthermore, FDG-PET imaging characteristics of non-resectable osteosarcoma before and after PT/HIT will be investigated prospectively. Systemic disease before and after PT/HIT is targeted by standard chemotherapy protocols and is not part of this trial. Discussion The primary objectives of this trial are the determination of feasibility and toxicity of HIT. Secondary objectives are tumor response

  19. Non-randomized therapy trial to determine the safety and efficacy of heavy ion radiotherapy in patients with non-resectable osteosarcoma

    International Nuclear Information System (INIS)

    Blattmann, Claudia; Nikoghosyan, Anna; Bischof, Marc; Jäkel, Oliver; Huber, Peter; Kulozik, Andreas E; Debus, Jürgen; Oertel, Susanne; Schulz-Ertner, Daniela; Rieken, Stefan; Haufe, Sabine; Ewerbeck, Volker; Unterberg, Andreas; Karapanagiotou-Schenkel, Irini; Combs, Stephanie E

    2010-01-01

    Osteosarcoma is the most common primary malignant bone tumor in children and adolescents. For effective treatment, local control of the tumor is absolutely critical, because the chances of long term survival are <10% and might effectively approach zero if a complete surgical resection of the tumor is not possible. Up to date there is no curative treatment protocol for patients with non-resectable osteosarcomas, who are excluded from current osteosarcoma trials, e.g. EURAMOS1. Local photon radiotherapy has previously been used in small series and in an uncontrolled, highly individualized fashion, which, however, documented that high dose radiotherapy can, in principle, be used to achieve local control. Generally the radiation dose that is necessary for a curative approach can hardly be achieved with conventional photon radiotherapy in patients with non-resectable tumors that are usually located near radiosensitive critical organs such as the brain, the spine or the pelvis. In these cases particle Radiotherapy (proton therapy (PT)/heavy ion therapy (HIT) may offer a promising new alternative. Moreover, compared with photons, heavy ion beams provide a higher physical selectivity because of their finite depth coverage in tissue. They achieve a higher relative biological effectiveness. Phase I/II dose escalation studies of HIT in adults with non-resectable bone and soft tissue sarcomas have already shown favorable results. This is a monocenter, single-arm study for patients ≥ 6 years of age with non-resectable osteosarcoma. Desired target dose is 60-66 Cobalt Gray Equivalent (Gy E) with 45 Gy PT (proton therapy) and a carbon ion boost of 15-21 GyE. Weekly fractionation of 5-6 × 3 Gy E is used. PT/HIT will be administered exclusively at the Ion Radiotherapy Center in Heidelberg. Furthermore, FDG-PET imaging characteristics of non-resectable osteosarcoma before and after PT/HIT will be investigated prospectively. Systemic disease before and after PT/HIT is targeted by

  20. Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer. Results of the first prospective randomized phase II trial

    Energy Technology Data Exchange (ETDEWEB)

    Golcher, Henriette; Merkel, Susanne; Hohenberger, Werner [University Hospital Erlangen, Department of Surgery, Erlangen (Germany); Brunner, Thomas B. [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany); University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany); Witzigmann, Helmut [University Hospital Leipzig, Department of Surgery, Leipzig (Germany); Hospital Dresden-Friedrichstadt, General Surgery, Dresden (Germany); Marti, Lukas [Hospital of Kanton St. Gallen, General Surgery, St. Gallen (Switzerland); Bechstein, Wolf-Otto [University Hospital Frankfurt, Department of Surgery, Frankfurt/Main (Germany); Bruns, Christiane [University Hospital Munich, Department of Surgery - Hospital Campus Grosshadern, Munich (Germany); University Hospital Magdeburg, Department of Surgery, Magdeburg (Germany); Jungnickel, Henry [Hospital Dresden-Friedrichstadt, General Surgery, Dresden (Germany); Schreiber, Stefan [University Hospital Leipzig, Department of Surgery, Leipzig (Germany); Grabenbauer, Gerhard G. [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany); Hospital Coburg, Department of Radiation Oncology, Coburg (Germany); Meyer, Thomas [University Hospital Erlangen, Department of Surgery, Erlangen (Germany); Hospital Ansbach, General Surgery, Ansbach (Germany); Fietkau, Rainer [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany)

    2014-09-25

    In nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging. Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS). The trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48 % (A) and 52 % (B, P = 0.81) and (y)pN0 was 30 % (A) vs. 39 % (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79). This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543. (orig.) [German] Mehrere nichtrandomisierte Studien zeigten, dass eine neoadjuvante Therapie das Ueberleben bei Patienten mit Pankreaskarzinom verlaengert. Beim lokal fortgeschrittenen Rektumkarzinom gehoert die

  1. GOLD MINERAL PROSPECTING USING PHASED ARRAY TYPE L-BAND SYNTHETIC APERTURE RADAR (PALSAR SATELLITE REMOTE SENSING DATA, CENTRAL GOLD BELT, MALAYSIA

    Directory of Open Access Journals (Sweden)

    A. Beiranvand Pour

    2016-06-01

    Full Text Available The Bentong-Raub Suture Zone (BRSZ of Peninsular Malaysia is one of the significant structural zones in Sundaland, Southeast Asia. It forms the boundary between the Gondwana-derived Sibumasu terrane in the west and Sukhothai arc in the east. The BRSZ is also genetically related to the sediment-hosted/orogenic gold deposits associated with the major lineaments and form-lines in the central gold belt Central Gold Belt of Peninsular Malaysia. In tropical environments, heavy tropical rainforest and intense weathering makes it impossible to map geological structures over long distances. Advances in remote sensing technology allow the application of Synthetic Aperture Radar (SAR data in geological structural analysis for tropical environments. In this investigation, the Phased Array type L-band Synthetic Aperture Radar (PALSAR satellite remote sensing data were used to analyse major geological structures in Peninsular Malaysia and provide detailed characterization of lineaments and form-lines in the BRSZ, as well as its implication for sediment-hosted/orogenic gold exploration in tropical environments. The major geological structure directions of the BRSZ are N-S, NNE-SSW, NE-SW and NW-SE, which derived from directional filtering analysis to PALSAR data. The pervasive array of N-S faults in the study area and surrounding terrain is mainly linked to the N-S trending of the Suture Zone. N-S striking lineaments are often cut by younger NE-SW and NW-SE-trending lineaments. Gold mineralized trends lineaments are associated with the intersection of N-S, NE-SW, NNW-SSE and ESE-WNW faults and curvilinear features in shearing and alteration zones. Lineament analysis on PALSAR satellite remote sensing data is a useful tool for detecting the boundary between the Gondwana-derived terranes and major geological features associated with suture zone especially for large inaccessible regions in tropical environments.

  2. Concurrent hyperfractionated accelerated radiotherapy with 5-FU and once weekly cisplatin in locally advanced head and neck cancer. The 10-year results of a prospective phase II trial

    International Nuclear Information System (INIS)

    Budach, V.; Boehmer, D.; Badakhshi, H.; Jahn, U.; Stromberger, C.; Becker, E.T.; Wernecke, K.D.

    2014-01-01

    In this study, the acute toxicity and long-term outcome of a hyperfractionated accelerated chemoradiation regimen with cisplatin/5-fluorouracil (5-FU) in patients with locally advanced squamous cell carcinomas of head and neck were evaluated. From 2000-2002, 38 patients with stage III (5.3 %) and stage IV (94.7 %) head and neck cancer were enrolled in a phase II study. Patients received hyperfractionated-accelerated radiotherapy with 72 Gy in 15 fractions of 2 Gy followed by 1.4 Gy twice daily with concurrent, continuous infusion 5-FU of 600 mg/m 2 on days 1-5 and 6 cycles of weekly cisplatin (30 mg/m 2 ). Acute toxicities (CTCAEv2.0), locoregional control (LRC), metastases-free (MFS), and overall survival (OS) were analyzed and exploratively compared with the ARO 95-06 trial. Median follow-up was 11.4 years (95 % CI 8.6-14.2) and mean dose 71.6 Gy. Of the patients, 82 % had 6 (n = 15) or 5 (n = 16) cycles of cisplatin, 5 and 2 patients received 4 and 3 cycles, respectively. Grade 3 anemia, leukopenia, and thrombocytopenia were observed in 15.8, 15.8, and 2.6 %, respectively. Grade 3 mucositis in 50 %, grade 3 and 4 dysphagia in 55 and 13 %. The 2-, 5-, and 10-year LRC was 65, 53.6, and 48.2 %, the MFS was 77.5, 66.7, and 57.2 % and the OS 59.6, 29.2, and 15 %, respectively. Chemoradiation with 5-FU and cisplatin seems feasible and superior in terms of LRC and OS to the ARO 95-06C-HART arm at 2 years. However, this did not persist at the 5- and 10-year follow-ups. (orig.) [de

  3. Induction Chemotherapy and Cetuximab for Locally Advanced Squamous Cell Carcinoma of the Head and Neck: Results From a Phase II Prospective Trial

    Science.gov (United States)

    Kies, Merrill S.; Holsinger, Floyd Christopher; Lee, J. Jack; William, William N.; Glisson, Bonnie S.; Lin, Heather Y.; Lewin, Jan S.; Ginsberg, Lawrence E.; Gillaspy, Katharine A.; Massarelli, Erminia; Byers, Lauren; Lippman, Scott M.; Hong, Waun K.; El-Naggar, Adel K.; Garden, Adam S.; Papadimitrakopoulou, Vassiliki

    2010-01-01

    Purpose To determine the potential efficacy of combining cetuximab with chemotherapy in patients with advanced nodal disease, we conducted a phase II trial with induction chemotherapy (ICT) consisting of six weekly cycles of paclitaxel 135 mg/m2 and carboplatin (area under the curve = 2) with cetuximab 400 mg/m2 in week 1 and then 250 mg/m2 (PCC). Patients and Methods Forty-seven previously untreated patients (41 with oropharynx primaries; 33 men, 14 women; median age, 53 years; performance status of 0 or 1) with squamous cell carcinoma of the head and neck (SCCHN; T1-4, N2b/c/3) were treated and evaluated for clinical and radiographic response. After ICT, patients underwent risk-based local therapy, which consisted of either radiation, concomitant chemoradiotherapy, or surgery, based on tumor stage and site at diagnosis. Results After induction PCC, nine patients (19%) achieved a complete response, and 36 patients (77%) achieved a partial response. The most common grade 3 or 4 toxicity was skin rash (45%), followed by neutropenia (21%) without fever. At a median follow-up time of 33 months, locoregional or systemic disease progression was observed in six patients. The 3-year progression-free survival (PFS) and overall survival (OS) rates were 87% (95% CI, 78% to 97%) and 91% (95% CI, 84% to 99%), respectively. Human papillomavirus (HPV) 16, found in 12 (46%) of 26 biopsies, was associated with improved PFS (P = .012) and OS (P = .046). Conclusion ICT with weekly PCC followed by risk-based local therapy seems to be feasible, effective, and well tolerated. PFS is promising, and this sequential treatment strategy should be further investigated. Patients with HPV-positive tumors have an excellent prognosis. PMID:19917840

  4. A prospective phase I-II trial of the cyclooxygenase-2 inhibitor celecoxib in patients with carcinoma of the cervix with biomarker assessment of the tumor microenvironment

    International Nuclear Information System (INIS)

    Herrera, Fernanda G.; Chan, Philip; Doll, Corinne; Milosevic, Michael; Oza, Amit; Syed, Amy; Pintilie, Melania; Levin, Wilfred; Manchul, Lee; Fyles, Anthony

    2007-01-01

    Purpose: To evaluate the toxicity and effectiveness of celecoxib in combination with definitive chemoradiotherapy (CRT) in women with locally advanced cervical cancer. Methods and Materials: Thirty-one patients were accrued to a phase I-II trial of celecoxib 400 mg by mouth twice per day for 2 weeks before and during CRT. Tumor oxygenation (HP 5 ) and interstitial fluid pressure (IFP) were measured before and 2 weeks after celecoxib administration alone. The median follow-up time was 2.7 years (range, 1.1-4.4 years). Results: The most common acute G3/4 toxicities were hematologic (4/31, 12.9%) and gastrointestinal (5/31, 16.1%) largely attributed to chemotherapy. Late G3/4 toxicity was seen in 4 of 31 patients (13.7% actuarial risk at 2 yr), including fistulas in 3 patients (9.7%). Within the first year of follow-up, 25 of 31 patients (81%) achieved complete response (CR), of whom 20 remained in CR at last follow-up. After 2 weeks of celecoxib administration before CRT, the median IFP decreased slightly (median absolute, -4.6 mm Hg; p = 0.09; relative, -21%; p = 0.07), whereas HP 5 did not change significantly (absolute increase, 3.6%; p = 0.51; median relative increase, 11%; p = 0.27). No significant associations were seen between changes in HP 5 or IFP and response to treatment (p = 0.2, relative HP 5 change and p = 0.14, relative IFP change). Conclusions: Celecoxib in combination with definitive CRT is associated with acceptable acute toxicity, but higher than expected late complications. Celecoxib is associated with a modest reduction in the angiogenic biomarker IFP, but this does not correspond with tumor response

  5. Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer. Results of the first prospective randomized phase II trial

    International Nuclear Information System (INIS)

    Golcher, Henriette; Merkel, Susanne; Hohenberger, Werner; Brunner, Thomas B.; Witzigmann, Helmut; Marti, Lukas; Bechstein, Wolf-Otto; Bruns, Christiane; Jungnickel, Henry; Schreiber, Stefan; Grabenbauer, Gerhard G.; Meyer, Thomas; Fietkau, Rainer

    2015-01-01

    In nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging. Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS). The trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48 % (A) and 52 % (B, P = 0.81) and (y)pN0 was 30 % (A) vs. 39 % (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79). This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543. (orig.) [de

  6. Prospective Randomized Phase 2 Trial of Intensity Modulated Radiation Therapy With or Without Oncolytic Adenovirus-Mediated Cytotoxic Gene Therapy in Intermediate-Risk Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Freytag, Svend O., E-mail: sfreyta1@hfhs.org [Department of Radiation Oncology, Henry Ford Health System, Detroit, Michigan (United States); Stricker, Hans [Vattikuti Urology Institute, Henry Ford Health System, Detroit, Michigan (United States); Lu, Mei [Public Health Sciences, Henry Ford Health System, Detroit, Michigan (United States); Elshaikh, Mohamed; Aref, Ibrahim; Pradhan, Deepak; Levin, Kenneth; Kim, Jae Ho [Department of Radiation Oncology, Henry Ford Health System, Detroit, Michigan (United States); Peabody, James [Vattikuti Urology Institute, Henry Ford Health System, Detroit, Michigan (United States); Siddiqui, Farzan; Barton, Kenneth; Pegg, Jan; Zhang, Yingshu; Cheng, Jingfang [Department of Radiation Oncology, Henry Ford Health System, Detroit, Michigan (United States); Oja-Tebbe, Nancy; Bourgeois, Renee [Public Health Sciences, Henry Ford Health System, Detroit, Michigan (United States); Gupta, Nilesh; Lane, Zhaoli [Pathology, Henry Ford Health System, Detroit, Michigan (United States); Rodriguez, Ron [Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); DeWeese, Theodore [Department of Radiation Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); and others

    2014-06-01

    Purpose: To assess the safety and efficacy of combining oncolytic adenovirus-mediated cytotoxic gene therapy (OAMCGT) with intensity modulated radiation therapy (IMRT) in intermediate-risk prostate cancer. Methods and Materials: Forty-four men with intermediate-risk prostate cancer were randomly assigned to receive either OAMCGT plus IMRT (arm 1; n=21) or IMRT only (arm 2; n=23). The primary phase 2 endpoint was acute (≤90 days) toxicity. Secondary endpoints included quality of life (QOL), prostate biopsy (12-core) positivity at 2 years, freedom from biochemical/clinical failure (FFF), freedom from metastases, and survival. Results: Men in arm 1 exhibited a greater incidence of low-grade influenza-like symptoms, transaminitis, neutropenia, and thrombocytopenia than men in arm 2. There were no significant differences in gastrointestinal or genitourinary events or QOL between the 2 arms. Two-year prostate biopsies were obtained from 37 men (84%). Thirty-three percent of men in arm 1 were biopsy-positive versus 58% in arm 2, representing a 42% relative reduction in biopsy positivity in the investigational arm (P=.13). There was a 60% relative reduction in biopsy positivity in the investigational arm in men with <50% positive biopsy cores at baseline (P=.07). To date, 1 patient in each arm exhibited biochemical failure (arm 1, 4.8%; arm 2, 4.3%). No patient developed hormone-refractory or metastatic disease, and none has died from prostate cancer. Conclusions: Combining OAMCGT with IMRT does not exacerbate the most common side effects of prostate radiation therapy and suggests a clinically meaningful reduction in positive biopsy results at 2 years in men with intermediate-risk prostate cancer.

  7. A Prospective Phase 2 Trial of Reirradiation With Stereotactic Body Radiation Therapy Plus Cetuximab in Patients With Previously Irradiated Recurrent Squamous Cell Carcinoma of the Head and Neck

    Energy Technology Data Exchange (ETDEWEB)

    Vargo, John A. [Department of Radiation Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania (United States); Ferris, Robert L. [Department of Radiation Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania (United States); Department of Otolaryngology, Head and Neck Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (United States); Ohr, James [Division Medical Oncology, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania (United States); Clump, David A. [Department of Radiation Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania (United States); Davis, Kara S.; Duvvuri, Umamaheswar; Kim, Seungwon; Johnson, Jonas T. [Department of Otolaryngology, Head and Neck Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (United States); Bauman, Julie E.; Gibson, Michael K. [Division Medical Oncology, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania (United States); Branstetter, Barton F. [Department of Radiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (United States); Heron, Dwight E., E-mail: herond2@umpc.edu [Department of Radiation Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania (United States); Department of Otolaryngology, Head and Neck Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (United States)

    2015-03-01

    Purpose: Salvage options for unresectable locally recurrent, previously irradiated squamous cell carcinoma of the head and neck (rSCCHN) are limited. Although the addition of reirradiation may improve outcomes compared to chemotherapy alone, significant toxicities limit salvage reirradiation strategies, leading to suboptimal outcomes. We therefore designed a phase 2 protocol to evaluate the efficacy of stereotactic body radiation therapy (SBRT) plus cetuximab for rSCCHN. Methods and Materials: From July 2007 to March 2013, 50 patients >18 years of age with inoperable locoregionally confined rSCCHN within a previously irradiated field receiving ≥60 Gy, with a Zubrod performance status of 0 to 2, and normal hepatic and renal function were enrolled. Patients received concurrent cetuximab (400 mg/m{sup 2} on day −7 and then 250 mg/m{sup 2} on days 0 and +8) plus SBRT (40-44 Gy in 5 fractions on alternating days over 1-2 weeks). Primary endpoints were 1-year locoregional progression-free survival and National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 graded toxicity. Results: Median follow-up for surviving patients was 18 months (range: 10-70). The 1-year local PFS rate was 60% (95% confidence interval [CI]: 44%-75%), locoregional PFS was 37% (95% CI: 23%-53%), distant PFS was 71% (95% CI: 54%-85%), and PFS was 33% (95% CI: 20%-49%). The median overall survival was 10 months (95% CI: 7-16), with a 1-year overall survival of 40% (95% CI: 26%-54%). At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression. Acute and late grade 3 toxicity was observed in 6% of patients respectively. Conclusions: SBRT with concurrent cetuximab appears to be a safe salvage treatment for rSCCHN of short overall treatment time.

  8. Neoadjuvant Sandwich Treatment With Oxaliplatin and Capecitabine Administered Prior to, Concurrently With, and Following Radiation Therapy in Locally Advanced Rectal Cancer: A Prospective Phase 2 Trial

    International Nuclear Information System (INIS)

    Gao, Yuan-Hong; Lin, Jun-Zhong; An, Xin; Luo, Jie-Lin; Cai, Mu-Yan; Cai, Pei-Qiang; Kong, Ling-Heng; Liu, Guo-Chen; Tang, Jing-Hua; Chen, Gong; Pan, Zhi-Zhong; Ding, Pei-Rong

    2014-01-01

    Purpose: Systemic failure remains the major challenge in management of locally advanced rectal cancer (LARC). To optimize the timing of neoadjuvant treatment and enhance systemic control, we initiated a phase 2 trial to evaluate a new strategy of neoadjuvant sandwich treatment, integrating induction chemotherapy, concurrent chemoradiation therapy, and consolidation chemotherapy. Here, we present preliminary results of this trial, reporting the tumor response, toxicities, and surgical complications. Methods and Materials: Fifty-one patients with LARC were enrolled, among which were two patients who were ineligible because of distant metastases before treatment. Patients were treated first with one cycle of induction chemotherapy consisting of oxaliplatin, 130 mg/m² on day 1, with capecitabine, 1000 mg/m² twice daily for 14 days every 3 weeks (the XELOX regimen), followed by chemoradiation therapy, 50 Gy over 5 weeks, with the modified XELOX regimen (oxaliplatin 100 mg/m²), and then with another cycle of consolidation chemotherapy with the XELOX regimen. Surgery was performed 6 to 8 weeks after completion of radiation therapy. Tumor responses, toxicities, and surgical complications were recorded. Results: All but one patent completed the planned schedule of neoadjuvant sandwich treatment. Neither life-threatening blood count decrease nor febrile neutropenia were observed. Forty-five patents underwent optimal surgery with total mesorectal excision (TME). Four patients refused surgery because of clinically complete response. There was no perioperative mortality in this cohort. Five patients (11.1%) developed postoperative complications. Among the 45 patients who underwent TME, pathologic complete response (pCR), pCR or major regression, and at least moderate regression were achieved in 19 (42.2%), 37 (82.2%), and 44 patients (97.8%), respectively. Conclusions: Preliminary results suggest that the strategy of neoadjuvant sandwich treatment using XELOX regimen

  9. A Prospective Phase 2 Trial of Reirradiation With Stereotactic Body Radiation Therapy Plus Cetuximab in Patients With Previously Irradiated Recurrent Squamous Cell Carcinoma of the Head and Neck

    International Nuclear Information System (INIS)

    Vargo, John A.; Ferris, Robert L.; Ohr, James; Clump, David A.; Davis, Kara S.; Duvvuri, Umamaheswar; Kim, Seungwon; Johnson, Jonas T.; Bauman, Julie E.; Gibson, Michael K.; Branstetter, Barton F.; Heron, Dwight E.

    2015-01-01

    Purpose: Salvage options for unresectable locally recurrent, previously irradiated squamous cell carcinoma of the head and neck (rSCCHN) are limited. Although the addition of reirradiation may improve outcomes compared to chemotherapy alone, significant toxicities limit salvage reirradiation strategies, leading to suboptimal outcomes. We therefore designed a phase 2 protocol to evaluate the efficacy of stereotactic body radiation therapy (SBRT) plus cetuximab for rSCCHN. Methods and Materials: From July 2007 to March 2013, 50 patients >18 years of age with inoperable locoregionally confined rSCCHN within a previously irradiated field receiving ≥60 Gy, with a Zubrod performance status of 0 to 2, and normal hepatic and renal function were enrolled. Patients received concurrent cetuximab (400 mg/m 2 on day −7 and then 250 mg/m 2 on days 0 and +8) plus SBRT (40-44 Gy in 5 fractions on alternating days over 1-2 weeks). Primary endpoints were 1-year locoregional progression-free survival and National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 graded toxicity. Results: Median follow-up for surviving patients was 18 months (range: 10-70). The 1-year local PFS rate was 60% (95% confidence interval [CI]: 44%-75%), locoregional PFS was 37% (95% CI: 23%-53%), distant PFS was 71% (95% CI: 54%-85%), and PFS was 33% (95% CI: 20%-49%). The median overall survival was 10 months (95% CI: 7-16), with a 1-year overall survival of 40% (95% CI: 26%-54%). At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression. Acute and late grade 3 toxicity was observed in 6% of patients respectively. Conclusions: SBRT with concurrent cetuximab appears to be a safe salvage treatment for rSCCHN of short overall treatment time

  10. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib: an international, multicentre, prospective, randomised, placebo-controlled phase 3 trial (GRID)

    Science.gov (United States)

    Demetri, George D; Reichardt, Peter; Kang, Yoon-Koo; Blay, Jean-Yves; Rutkowski, Piotr; Gelderblom, Hans; Hohenberger, Peter; Leahy, Michael; von Mehren, Margaret; Joensuu, Heikki; Badalamenti, Giuseppe; Blackstein, Martin; Cesne, Axel Le; Schöffski, Patrick; Maki, Robert G; Bauer, Sebastian; Nguyen, Binh Bui; Xu, Jianming; Nishida, Toshirou; Chung, John; Kappeler, Christian; Kuss, Iris; Laurent, Dirk; Casali, Paolo

    2013-01-01

    Summary Background To date, only two agents, imatinib and sunitinib, have shown clinical benefit in patients with gastrointestinal stromal tumours (GISTs), but almost all metastatic GISTs eventually develop resistance to these agents, resulting in fatal disease progression. This phase 3 trial assessed efficacy and safety of regorafenib in patients with metastatic and/or unresectable GIST progressing after failure of at least imatinib and sunitinib. Methods Patients were randomised 2:1 to receive either regorafenib 160 mg orally daily or placebo, plus best supportive care in both arms, for the first 3 weeks of each 4-week cycle. The primary endpoint was progression-free survival (PFS). Upon disease progression, patients on placebo could cross over to regorafenib. Secondary endpoints included overall survival (OS), objective response rate, disease control rate (DCR: rate of durable stable disease lasting for ≥12 weeks plus complete or partial responses), and safety. This trial is registered at ClinicalTrials.gov (NCT01271712). Results From January to August 2011, 240 patients were screened at 57 centres in 17 countries, and 199 patients were randomised to receive regorafenib (n=133) or matching placebo (n=66). Median PFS per independent blinded central review was 4·8 months and 0·9 months, respectively (hazard ratio [HR] 0·27, 95% confidence interval [CI] 0·19–0·39; pregorafenib, resulting in no significant difference in OS between study arms (HR 0·77, 95% CI 0·42–1·41; p=0·199). A best response of partial response or stable disease was observed in 101/133 patients (75·9%) on regorafenib and 23/66 patients (34·8%) on placebo. DCR was 52·6% (70/133 patients) and 9·1% (6/66 patients), respectively. Drug-related adverse events were reported in 130 (98·5%) of 132 regorafenib patients and 45 (68·2%) of 66 placebo patients. The most common grade ≥3 regorafenib-related adverse events were hypertension (31/132, 23·5%), hand–foot skin reaction (26

  11. Neoadjuvant Sandwich Treatment With Oxaliplatin and Capecitabine Administered Prior to, Concurrently With, and Following Radiation Therapy in Locally Advanced Rectal Cancer: A Prospective Phase 2 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Gao, Yuan-Hong [State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou (China); Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou (China); Lin, Jun-Zhong [State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou (China); Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou (China); An, Xin [State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou (China); Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou (China); Luo, Jie-Lin [State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou (China); Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou (China); Cai, Mu-Yan [State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou (China); Department of Pathology, Sun Yat-sen University Cancer Center, Guangzhou (China); Cai, Pei-Qiang [State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou (China); Department of Medical Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center, Guangzhou (China); Kong, Ling-Heng; Liu, Guo-Chen; Tang, Jing-Hua; Chen, Gong; Pan, Zhi-Zhong [State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou (China); Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou (China); Ding, Pei-Rong, E-mail: dingpr@mail.sysu.edu.cn [State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou (China); Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou (China)

    2014-12-01

    Purpose: Systemic failure remains the major challenge in management of locally advanced rectal cancer (LARC). To optimize the timing of neoadjuvant treatment and enhance systemic control, we initiated a phase 2 trial to evaluate a new strategy of neoadjuvant sandwich treatment, integrating induction chemotherapy, concurrent chemoradiation therapy, and consolidation chemotherapy. Here, we present preliminary results of this trial, reporting the tumor response, toxicities, and surgical complications. Methods and Materials: Fifty-one patients with LARC were enrolled, among which were two patients who were ineligible because of distant metastases before treatment. Patients were treated first with one cycle of induction chemotherapy consisting of oxaliplatin, 130 mg/m² on day 1, with capecitabine, 1000 mg/m² twice daily for 14 days every 3 weeks (the XELOX regimen), followed by chemoradiation therapy, 50 Gy over 5 weeks, with the modified XELOX regimen (oxaliplatin 100 mg/m²), and then with another cycle of consolidation chemotherapy with the XELOX regimen. Surgery was performed 6 to 8 weeks after completion of radiation therapy. Tumor responses, toxicities, and surgical complications were recorded. Results: All but one patent completed the planned schedule of neoadjuvant sandwich treatment. Neither life-threatening blood count decrease nor febrile neutropenia were observed. Forty-five patents underwent optimal surgery with total mesorectal excision (TME). Four patients refused surgery because of clinically complete response. There was no perioperative mortality in this cohort. Five patients (11.1%) developed postoperative complications. Among the 45 patients who underwent TME, pathologic complete response (pCR), pCR or major regression, and at least moderate regression were achieved in 19 (42.2%), 37 (82.2%), and 44 patients (97.8%), respectively. Conclusions: Preliminary results suggest that the strategy of neoadjuvant sandwich treatment using XELOX regimen

  12. Functional imaging and circulating biomarkers of response to regorafenib in treatment-refractory metastatic colorectal cancer patients in a prospective phase II study.

    Science.gov (United States)

    Khan, Khurum; Rata, Mihaela; Cunningham, David; Koh, Dow-Mu; Tunariu, Nina; Hahne, Jens C; Vlachogiannis, George; Hedayat, Somaieh; Marchetti, Silvia; Lampis, Andrea; Damavandi, Mahnaz Darvish; Lote, Hazel; Rana, Isma; Williams, Anja; Eccles, Suzanne A; Fontana, Elisa; Collins, David; Eltahir, Zakaria; Rao, Sheela; Watkins, David; Starling, Naureen; Thomas, Jan; Kalaitzaki, Eleftheria; Fotiadis, Nicos; Begum, Ruwaida; Bali, Maria; Rugge, Massimo; Temple, Eleanor; Fassan, Matteo; Chau, Ian; Braconi, Chiara; Valeri, Nicola

    2017-08-08

    Regorafenib demonstrated efficacy in patients with metastatic colorectal cancer (mCRC). Lack of predictive biomarkers, potential toxicities and cost-effectiveness concerns highlight the unmet need for better patient selection. Patients with RAS mutant mCRC with biopsiable metastases were enrolled in this phase II trial. Dynamic contrast-enhanced (DCE) MRI was acquired pretreatment and at day 15 post-treatment. Median values of volume transfer constant (K trans ), enhancing fraction (EF) and their product KEF (summarised median values of K trans × EF) were generated. Circulating tumour (ct) DNA was collected monthly until progressive disease and tested for clonal RAS mutations by digital-droplet PCR. Tumour vasculature (CD-31) was scored by immunohistochemistry on 70 sequential tissue biopsies. Twenty-seven patients with paired DCE-MRI scans were analysed. Median KEF decrease was 58.2%. Of the 23 patients with outcome data, >70% drop in KEF (6/23) was associated with higher disease control rate (p=0.048) measured by RECIST V. 1.1 at 2 months, improved progression-free survival (PFS) (HR 0.16 (95% CI 0.04 to 0.72), p=0.02), 4-month PFS (66.7% vs 23.5%) and overall survival (OS) (HR 0.08 (95% CI 0.01 to 0.63), p=0.02). KEF drop correlated with CD-31 reduction in sequential tissue biopsies (p=0.04). RAS mutant clones decay in ctDNA after 8 weeks of treatment was associated with better PFS (HR 0.21 (95% CI 0.06 to 0.71), p=0.01) and OS (HR 0.28 (95% CI 0.07-1.04), p=0.06). Combining DCE-MRI and ctDNA predicts duration of anti-angiogenic response to regorafenib and may improve patient management with potential health/economic implications. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  13. Concurrent hyperfractionated accelerated radiotherapy with 5-FU and once weekly cisplatin in locally advanced head and neck cancer. The 10-year results of a prospective phase II trial

    Energy Technology Data Exchange (ETDEWEB)

    Budach, V.; Boehmer, D.; Badakhshi, H.; Jahn, U.; Stromberger, C. [Campus Virchow Klinikum, Charite Universitaetsmedizin Berlin, Department for Radiooncology, Clinic for Radiooncology, Berlin (Germany); Becker, E.T. [Charite Universitaetsmedizin, Department of Otorhinolaryngology, Berlin (Germany); Wernecke, K.D. [Sostana Statistics GmbH, Charite Universitaetsmedizin Berlin, Berlin (Germany)

    2014-03-15

    In this study, the acute toxicity and long-term outcome of a hyperfractionated accelerated chemoradiation regimen with cisplatin/5-fluorouracil (5-FU) in patients with locally advanced squamous cell carcinomas of head and neck were evaluated. From 2000-2002, 38 patients with stage III (5.3 %) and stage IV (94.7 %) head and neck cancer were enrolled in a phase II study. Patients received hyperfractionated-accelerated radiotherapy with 72 Gy in 15 fractions of 2 Gy followed by 1.4 Gy twice daily with concurrent, continuous infusion 5-FU of 600 mg/m{sup 2} on days 1-5 and 6 cycles of weekly cisplatin (30 mg/m{sup 2}). Acute toxicities (CTCAEv2.0), locoregional control (LRC), metastases-free (MFS), and overall survival (OS) were analyzed and exploratively compared with the ARO 95-06 trial. Median follow-up was 11.4 years (95 % CI 8.6-14.2) and mean dose 71.6 Gy. Of the patients, 82 % had 6 (n = 15) or 5 (n = 16) cycles of cisplatin, 5 and 2 patients received 4 and 3 cycles, respectively. Grade 3 anemia, leukopenia, and thrombocytopenia were observed in 15.8, 15.8, and 2.6 %, respectively. Grade 3 mucositis in 50 %, grade 3 and 4 dysphagia in 55 and 13 %. The 2-, 5-, and 10-year LRC was 65, 53.6, and 48.2 %, the MFS was 77.5, 66.7, and 57.2 % and the OS 59.6, 29.2, and 15 %, respectively. Chemoradiation with 5-FU and cisplatin seems feasible and superior in terms of LRC and OS to the ARO 95-06C-HART arm at 2 years. However, this did not persist at the 5- and 10-year follow-ups. (orig.) [German] Untersuchung der Akuttoxizitaet und des Langzeitueberlebens einer hyperfraktioniert-akzelerierten simultanen Radiochemotherapie mit Cisplatin/5-Fluorouracil (5-FU) bei Patienten mit lokal fortgeschrittenen Kopf-Hals-Tumoren. Von 2000 bis 2002 wurden 38 Patienten mit Plattenepithelkarzinomen der Kopf-Hals-Region im Stadium III (5,3 %) und IV (94,7 %) eingeschlossen. Es erfolgte eine simultane hyperfraktionierte akzelerierte Radiochemotherapie mit 72 Gy in 15 Fraktionen a 2 Gy

  14. Moderate risk-adapted dose escalation with 3D-conformal radiotherapy for prostate cancer from 70 to 74 Gy : long-term morbidity and survival from a prospective phase II trial

    International Nuclear Information System (INIS)

    Bombosch, V. B.

    2015-01-01

    Abstract English Background and Purpose: Evaluation of late side-effects and survival more than 60 months after 3-dimensional conformal radiotherapy with moderate, risk adapted dose escalation from 70 to 74 Gy in patients with localized prostate cancer within a prospective Austrian-German phase II multicenter trial. Material and Methods: Between 03/1999 and 07/2002 486 patients were registered in the prospective Austrian-German multicenter phase II trial. 441 (90.7%) patients were evaluated. Patients in the low and intermediate risk group were treated with 70Gy, patients in the high risk group received 74Gy. Additional hormonal-therapy was recommended for intermediate- and high-risk group patients. Gastrointestinal (GI) and genitourinary (GU) late toxicity according to EORTC/RTOG criteria, initial appearance, prevalence and duration of grade >=2 side-effects were investigated. Furthermore bNED (Phoenix/Nadir + 2), overall and disease specific survival were prospectively assessed. Results: Median follow-up was 90 (2-158) months in all 441 patients and 99 (18-158) months in living patients. 154 patients (35%) had a follow-up of longer or equal 120 months. Distribution among risk groups was 26% (low), 51% (intermediate) and 23% (high). HT was administered in 86% of patients prior to RT. Late gastrointestinal side-effects at 5- and 10 years were 29%/32% (70/74Gy) and 30%/35% (70/74Gy) as actuarial rates; p=0.67. Late genitourinary side-effects at 5- and 10 years were 17%/26% (70/74Gy) and 27%/34% (70/74Gy); p=0.12. No more than 15% (GI) and 15% (GU) of patients suffered from side-effects >=2 at any time after the end of therapy (prevalence). The proportion of patients suffering from severe toxicity was low (Grade 3 GI: 2%, GU: 10%). 10 year actuarial bNED rate was 65%, 70% and 58% in the low-, intermediate- and high risk group according to Phoenix (Nadir +2) criteria. Overall and disease specific survival were 67% and 91% in all patients. Conclusion: Dose escalation

  15. Efficacy of Wobe-Mugos {sup registered} E for reduction of oral mucositis after radiotherapy. Results of a prospective, randomized, placebo-controlled, triple-blind phase III multicenter study

    Energy Technology Data Exchange (ETDEWEB)

    Doerr, W.; Herrmann, T. [Univ. of Technology, Dresden (Germany). Dept. of Radiotherapy and Radiooncology, Medical Faculty Carl Gustav Carus

    2007-03-15

    Purpose: To investigate the efficacy and safety of Wobe-Mugos {sup registered} E (proteolytic enzymes) for amelioration of early side effects of radiotherapy for head-and-neck tumors, particularly oral mucositis. Patients and Methods: The study was a prospective, randomized, multicenter, placebo-controlled, triple-blind phase III study with parallel groups. 69 patients with carcinomas of the oropharynx or the oral cavity were enrolled between 1996 and 2000 in five centers; 54 of these were recruited in Dresden. Of the 69 patients, 61 (Dresden: 46) were available for analysis. The proteolytic enzymes tested (Wobe-Mugos {sup registered} E) comprised papain 100 mg, trypsin 40 mg, and chymotrypsin 40 mg. Results: Wobe-Mugos {sup registered} E was well tolerated. For the maximum mucositis scores, no statistically significant differences were found between the placebo and the verum group. The average mucositis score over weeks 1-6 revealed a significant difference in favor of the placebo arm, based on an earlier onset of mucositis in the Wobe-Mugos {sup registered} E group. Conclusion: The present study failed to demonstrate any effect of treatment with Wobe-Mugos {sup registered} E on radiotherapy side effects in patients treated for head-and-neck tumors. In particular, there was no beneficial effect on radiation-induced early oral mucositis. (orig.)

  16. Efficacy of Wobe-Mugos registered E for reduction of oral mucositis after radiotherapy. Results of a prospective, randomized, placebo-controlled, triple-blind phase III multicenter study

    International Nuclear Information System (INIS)

    Doerr, W.; Herrmann, T.

    2007-01-01

    Purpose: To investigate the efficacy and safety of Wobe-Mugos registered E (proteolytic enzymes) for amelioration of early side effects of radiotherapy for head-and-neck tumors, particularly oral mucositis. Patients and Methods: The study was a prospective, randomized, multicenter, placebo-controlled, triple-blind phase III study with parallel groups. 69 patients with carcinomas of the oropharynx or the oral cavity were enrolled between 1996 and 2000 in five centers; 54 of these were recruited in Dresden. Of the 69 patients, 61 (Dresden: 46) were available for analysis. The proteolytic enzymes tested (Wobe-Mugos registered E) comprised papain 100 mg, trypsin 40 mg, and chymotrypsin 40 mg. Results: Wobe-Mugos registered E was well tolerated. For the maximum mucositis scores, no statistically significant differences were found between the placebo and the verum group. The average mucositis score over weeks 1-6 revealed a significant difference in favor of the placebo arm, based on an earlier onset of mucositis in the Wobe-Mugos registered E group. Conclusion: The present study failed to demonstrate any effect of treatment with Wobe-Mugos registered E on radiotherapy side effects in patients treated for head-and-neck tumors. In particular, there was no beneficial effect on radiation-induced early oral mucositis. (orig.)

  17. Histologic Evidence of New Collagen Formulation Using Platelet Rich Plasma in Skin Rejuvenation: A Prospective Controlled Clinical Study

    OpenAIRE

    Abuaf, Ozlem Karabudak; Yildiz, Hamza; Baloglu, H?seyin; Bilgili, Memet Ersan; Simsek, Hasan Aktug; Dogan, Bilal

    2016-01-01

    Background Platelet-rich plasma (PRP) is an autologous concentration of human platelets contained in a small volume of plasma and has recently been shown to accelerate rejuvenate aging skin by various growth factors and cell adhesion molecules. Objective This study was conducted to evaluate the efficacy and safety of intradermal injection of PRP in the human facial rejuvenation. Methods This study was a prospective, single-center, single-dose, open-label, non-randomized controlled clinical st...

  18. An open-label, non-randomized study of the pharmacokinetics of the nutritional supplement nicotinamide riboside (NR and its effects on blood NAD+ levels in healthy volunteers.

    Directory of Open Access Journals (Sweden)

    Sophia E Airhart

    Full Text Available The co-primary objectives of this study were to determine the human pharmacokinetics (PK of oral NR and the effect of NR on whole blood nicotinamide adenine dinucleotide (NAD+ levels.Though mitochondrial dysfunction plays a critical role in the development and progression of heart failure, no mitochondria-targeted therapies have been translated into clinical practice. Recent murine studies have reported associations between imbalances in the NADH/NAD+ ratio with mitochondrial dysfunction in multiple tissues, including myocardium. Moreover, an NAD+ precursor, nicotinamide mononucleotide, improved cardiac function, while another NAD+ precursor, nicotinamide riboside (NR, improved mitochondrial function in muscle, liver and brown adipose. Thus, PK studies of NR in humans is critical for future clinical trials.In this non-randomized, open-label PK study of 8 healthy volunteers, 250 mg NR was orally administered on Days 1 and 2, then uptitrated to peak dose of 1000 mg twice daily on Days 7 and 8. On the morning of Day 9, subjects completed a 24-hour PK study after receiving 1000 mg NR at t = 0. Whole-blood levels of NR, clinical blood chemistry, and NAD+ levels were analyzed.Oral NR was well tolerated with no adverse events. Significant increases comparing baseline to mean concentrations at steady state (Cave,ss were observed for both NR (p = 0.03 and NAD+ (p = 0.001; the latter increased by 100%. Absolute changes from baseline to Day 9 in NR and NAD+ levels correlated highly (R2 = 0.72, p = 0.008.Because NR increases circulating NAD+ in humans, NR may have potential as a therapy in patients with mitochondrial dysfunction due to genetic and/or acquired diseases.

  19. An open-label, non-randomized study of the pharmacokinetics of the nutritional supplement nicotinamide riboside (NR) and its effects on blood NAD+ levels in healthy volunteers.

    Science.gov (United States)

    Airhart, Sophia E; Shireman, Laura M; Risler, Linda J; Anderson, Gail D; Nagana Gowda, G A; Raftery, Daniel; Tian, Rong; Shen, Danny D; O'Brien, Kevin D

    2017-01-01

    The co-primary objectives of this study were to determine the human pharmacokinetics (PK) of oral NR and the effect of NR on whole blood nicotinamide adenine dinucleotide (NAD+) levels. Though mitochondrial dysfunction plays a critical role in the development and progression of heart failure, no mitochondria-targeted therapies have been translated into clinical practice. Recent murine studies have reported associations between imbalances in the NADH/NAD+ ratio with mitochondrial dysfunction in multiple tissues, including myocardium. Moreover, an NAD+ precursor, nicotinamide mononucleotide, improved cardiac function, while another NAD+ precursor, nicotinamide riboside (NR), improved mitochondrial function in muscle, liver and brown adipose. Thus, PK studies of NR in humans is critical for future clinical trials. In this non-randomized, open-label PK study of 8 healthy volunteers, 250 mg NR was orally administered on Days 1 and 2, then uptitrated to peak dose of 1000 mg twice daily on Days 7 and 8. On the morning of Day 9, subjects completed a 24-hour PK study after receiving 1000 mg NR at t = 0. Whole-blood levels of NR, clinical blood chemistry, and NAD+ levels were analyzed. Oral NR was well tolerated with no adverse events. Significant increases comparing baseline to mean concentrations at steady state (Cave,ss) were observed for both NR (p = 0.03) and NAD+ (p = 0.001); the latter increased by 100%. Absolute changes from baseline to Day 9 in NR and NAD+ levels correlated highly (R2 = 0.72, p = 0.008). Because NR increases circulating NAD+ in humans, NR may have potential as a therapy in patients with mitochondrial dysfunction due to genetic and/or acquired diseases.

  20. Effect of cognitive behavioral group therapy for recovery of self-esteem on community-living individuals with mental illness: Non-randomized controlled trial.

    Science.gov (United States)

    Kunikata, Hiroko; Yoshinaga, Naoki; Nakajima, Kazuo

    2016-10-01

    The aim of this study was to examine over a 12-month post-intervention period whether the participation of community-living individuals with mental illness in cognitive behavioral group therapy for recovery of self-esteem (CBGTRS) resulted in improved outcomes. This was a non-randomized controlled trial. The participants were persons with mental illness who resided in communities in the Chugoku region of Japan. In total, 41 were assigned to an experimental group (CBGTRS intervention, 12 group sessions), and 21 to a control group. Outcome indices (self-esteem, moods, cognition, subjective well-being, psychiatric symptoms) were measured for the experimental group prior to intervention (T0), immediately post-intervention (T1), and at 3 (T2) and 12 (T3) months post-intervention. The control group was measured at the same intervals. For the experimental group, self-esteem scores at T1, T2, and T3 were significantly higher than at T0. Moods and cognition scores remained significantly low until T2. Scores for Inadequate Mental Mastery in the subjective well-being index had not decreased by T3. Confidence in Coping remained significantly high until T2. Psychiatric symptoms scores at T0, T1, T2, and T3 were significantly lower than at T0. The means and standard errors for self-esteem and Inadequate Mental Mastery increased until T3, and those for Tension-Anxiety, Depression-Dejection, and Confusion decreased until T2. From within-group trends and between-group differences in self-esteem, we conclude that CBGTRS may have a relatively long-term effect on self-esteem recovery. T2 is the turning point for moods and cognition; thus, follow-up is needed 3 months following the initial program. © 2016 The Authors. Psychiatry and Clinical Neurosciences © 2016 Japanese Society of Psychiatry and Neurology.

  1. Sustainability of motor performance after robotic-assisted treadmill therapy in children: an open, non-randomized baseline-treatment study.

    Science.gov (United States)

    Borggraefe, I; Kiwull, L; Schaefer, J S; Koerte, I; Blaschek, A; Meyer-Heim, A; Heinen, F

    2010-06-01

    The aim of the study was to investigate the sustainability of motor improvements achieved after a three week trial of robotic assisted treadmill therapy in children and adolescents with central gait disorders within a follow up period of about six months. Open, non-randomized, baseline-treatment study. Fourteen patients (mean age 8.2+/-5.4) underwent a trial of 12 sessions of robotic-assisted treadmill therapy using the Lokomat over a period of three weeks. Outcome measures were the dimensions D (standing) and E (walking) of the Gross Motor Function Measure, the ten meter walking test and the six minute walking test. Outcome variables were evaluated immediately before and after the trial and at a follow up of about six months. Improvements after the trial in the dimension D from 49.5% to 54.4% (P=0.008) and from 38.9% to 42.3% (P=0.012) in the dimension E of the GMFM were seen and are within the same range of previously published results. The mean score at the follow up after six months was 56.8% and 43.3% for dimension D and E, respectively. Gait speed improved from 0.80 m/s to 1.01 m/s (P=0.006) after the trial and was 1.11 m/s at the follow-up visit at six months. Similar results were obtained for endurance. The improvements of motor function after a three-week trial of robotic-assisted treadmill therapy appear to be sustained after a mean period of six months.

  2. Effectiveness of a peer-led HIV prevention intervention in secondary schools in Rwanda: results from a non-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Michielsen Kristien

    2012-09-01

    Full Text Available Abstract Background While the HIV epidemic is levelling off in sub-Saharan Africa, it remains at an unacceptably high level. Young people aged 15-24 years remain particularly vulnerable, resulting in a regional HIV prevalence of 1.4% in young men and 3.3% in young women. This study assesses the effectiveness of a peer-led HIV prevention intervention in secondary schools in Rwanda on young people’s sexual behavior, HIV knowledge and attitudes. Methods In a non-randomized longitudinal controlled trial, fourteen schools were selected in two neighboring districts in Rwanda Bugesera (intervention and Rwamagana (control. Students (n = 1950 in eight intervention and six control schools participated in three surveys (baseline, six and twelve months in the intervention. Analysis was done using linear and logistic regression using generalized estimation equations adjusted for propensity score. Results The overall retention rate was 72%. Time trends in sexual risk behavior (being sexually active, sex in last six months, condom use at last sex were not significantly different in students from intervention and control schools, nor was the intervention associated with increased knowledge, perceived severity or perceived susceptibility. It did significantly reduce reported stigma. Conclusions Analyzing this and other interventions, we identified several reasons for the observed limited effectiveness of peer education: 1 intervention activities (spreading information are not tuned to objectives (changing behavior; 2 young people prefer receiving HIV information from other sources than peers; 3 outcome indicators are not adequate and the context of the relationship in which sex occurs and the context in which sex occurs is ignored. Effectiveness of peer education may increase through integration in holistic interventions and redefining peer educators’ role as focal points for sensitization and referral to experts and services. Finally, we argue that a

  3. Effective group training for patients with unexplained physical symptoms: a randomized controlled trial with a non-randomized one-year follow-up.

    Directory of Open Access Journals (Sweden)

    Lyonne N L Zonneveld

    Full Text Available BACKGROUND: Although cognitive-behavioral therapy for Unexplained Physical Symptoms (UPS is effective in secondary care, studies done in primary care produced implementation problems and conflicting results. We evaluated the effectiveness of a cognitive-behavioral group training tailored to primary care patients and provided by a secondary community mental-health service reaching out into primary care. METHODOLOGY/PRINCIPAL FINDINGS: The effectiveness of this training was explored in a randomized controlled trial. In this trial, 162 patients with UPS classified as undifferentiated somatoform disorder or as chronic pain disorder were randomized either to the training or a waiting list. Both lasted 13 weeks. The preservation of the training's effect was analyzed in non-randomized follow-ups, for which the waiting group started the training after the waiting period. All patients attended the training were followed-up after three months and again after one year. The primary outcomes were the physical and the mental summary scales of the SF-36. Secondary outcomes were the other SF-36-scales and the SCL-90-R. The courses of the training's effects in the randomized controlled trial and the follow-ups were analyzed with linear mixed modeling. In the randomized controlled trial, the training had a significantly positive effect on the quality of life in the physical domain (Cohen's d = 0.38;p = .002, but this overall effect was not found in the mental domain. Regarding the secondary outcomes, the training resulted in reporting an improved physical (Cohen's d = 0.43;p = 0.01, emotional (Cohen's d = 0.44;p = 0.01, and social (Cohen's d = 0.36;p = 0.01 functioning, less pain and better functioning despite pain (Cohen's d = 0.51;p =

  4. Subsurface Prospecting by Planetary Drones, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Recurring slope linae (RSL), such as those in Newton Crater on Mars, methane plumes in hazardous Martian terrain, and water ice discovered during the LCROSS...

  5. A psycho-educational HIV/STI prevention intervention for internally displaced women in Leogane, Haiti: results from a non-randomized cohort pilot study.

    Science.gov (United States)

    Logie, Carmen H; Daniel, CarolAnn; Newman, Peter A; Weaver, James; Loutfy, Mona R

    2014-01-01

    Little evidence exists regarding efficacious HIV and sexually transmitted infections (STI) prevention interventions with internally displaced populations. Internally displaced women are at elevated risk for HIV/STI due to limited access to health services, heightened poverty and social network breakdown. The FASY (Famn an Aksyon Pou Sante' Yo) (Women Taking Action For Their Health) study examined the effectiveness of a peer health worker (PHW) delivered psycho-educational HIV/STI pilot study with internally displaced women in Leogane, Haiti. This was a non-randomized cohort pilot study. Participants completed a computer-assisted pre-test programmed on Android tablet PCs followed by an HIV/STI educational video-based session and a 6-week psycho-educational group program of weekly meetings. Participants completed a post-test upon completion of group sessions. The primary outcome was HIV knowledge; our pre-specified index of clinically significant change was an effect size of 0.30. Secondary outcomes included: STI knowledge, condom use, social support, resilient coping, depression and relationship control. We used mixed-effects regression to calculate mean outcome pre-post score change. This study was registered (clinicaltrials.gov, NCT01492829). Between January 1-April 30, 2012 we assigned 200 participants to the study. The majority of participants (n = 176, 88%) completed the study and were followed up at 8 weeks, finishing April 30, 2012. Adjusted for socio-demographic characteristics, HIV knowledge (β = 4.81; 95% CI 4.36-5.26), STI knowledge (β = 0.84; 95% CI 0.70-0.99), condom use (AOR = 4.05, 95% CI 1.86-8.83), and depression (β = -0.63, 95% CI -0.88--0.39) scores showed statistically significant change post-intervention (pHaiti. Pilot studies are an important approach to understand feasibility and scientific impacts of HIV prevention strategies in disaster contexts. Study results may inform HIV prevention interventions among internally displaced women in

  6. A psycho-educational HIV/STI prevention intervention for internally displaced women in Leogane, Haiti: results from a non-randomized cohort pilot study.

    Directory of Open Access Journals (Sweden)

    Carmen H Logie

    Full Text Available Little evidence exists regarding efficacious HIV and sexually transmitted infections (STI prevention interventions with internally displaced populations. Internally displaced women are at elevated risk for HIV/STI due to limited access to health services, heightened poverty and social network breakdown. The FASY (Famn an Aksyon Pou Sante' Yo (Women Taking Action For Their Health study examined the effectiveness of a peer health worker (PHW delivered psycho-educational HIV/STI pilot study with internally displaced women in Leogane, Haiti.This was a non-randomized cohort pilot study. Participants completed a computer-assisted pre-test programmed on Android tablet PCs followed by an HIV/STI educational video-based session and a 6-week psycho-educational group program of weekly meetings. Participants completed a post-test upon completion of group sessions. The primary outcome was HIV knowledge; our pre-specified index of clinically significant change was an effect size of 0.30. Secondary outcomes included: STI knowledge, condom use, social support, resilient coping, depression and relationship control. We used mixed-effects regression to calculate mean outcome pre-post score change. This study was registered (clinicaltrials.gov, NCT01492829.Between January 1-April 30, 2012 we assigned 200 participants to the study. The majority of participants (n = 176, 88% completed the study and were followed up at 8 weeks, finishing April 30, 2012. Adjusted for socio-demographic characteristics, HIV knowledge (β = 4.81; 95% CI 4.36-5.26, STI knowledge (β = 0.84; 95% CI 0.70-0.99, condom use (AOR = 4.05, 95% CI 1.86-8.83, and depression (β = -0.63, 95% CI -0.88--0.39 scores showed statistically significant change post-intervention (p<0.05.This pilot study evaluated a PHW psycho-educational HIV/STI prevention intervention among internally displaced women in post-earthquake Haiti. Pilot studies are an important approach to understand feasibility and scientific

  7. TP53 status and taxane-platinum versus platinum-based therapy in ovarian cancer patients: A non-randomized retrospective study

    Directory of Open Access Journals (Sweden)

    Markowska Janina

    2008-01-01

    Full Text Available Abstract Background Taxane-platinum therapy (TP has replaced platinum-based therapy (PC or PAC, DNA damaging chemotherapy in the postoperative treatment of ovarian cancer patients; however, it is not always effective. TP53 protein plays a differential role in response to DNA-damaging agents and taxanes. We sought to define profiles of patients who benefit the most from TP and also of those who can be treated with PC. Methods We compared the effectiveness of PC/PAC (n = 253 and TP (n = 199 with respect to tumor TP53 accumulation in ovarian cancer patients with FIGO stage IIB-IV disease; this was a non-randomized retrospective study. Immunohistochemical analysis was performed on 452 archival tumors; univariate and multivariate analysis by the Cox's and logistic regression models was performed in all patients and in subgroups with [TP53(+] and without TP53 accumulation [TP53(-]. Results The advantage of taxane-platinum therapy over platinum-based therapy was seen in the TP53(+, and not in the TP53(- group. In the TP53(+ group taxane-platinum therapy enhanced the probability of complete remission (p = .018, platinum sensitivity (p = .014, platinum highly sensitive response (p = .038 and longer survival (OS, p = .008. Poor tumor differentiation diminished the advantage from taxane-platinum therapy in the TP53(+ group. In the TP53(- group PC/PAC was at least equally efficient as taxane-platinum therapy and it enhanced the chance of platinum highly sensitive response (p = .010. However, in the TP53(- group taxane-platinum therapy possibly diminished the risk of death in patients over 53 yrs (p = .077. Among factors that positively interacted with taxane-platinum therapy in some analyses were endometrioid and clear cell type, FIGO III stage, bulky residual tumor, more advanced age of patient and moderate tumor differentiation. Conclusion Our results suggest that taxane-platinum therapy is particularly justified in patients with TP53(+ tumors or older

  8. A phase 1–2, prospective, double blind, randomized study of the safety and efficacy of Sulfasalazine for the treatment of progressing malignant gliomas: study protocol of [ISRCTN45828668

    International Nuclear Information System (INIS)

    Robe, Pierre A; Martin, Didier; Albert, Adelin; Deprez, Manuel; Chariot, Alain; Bours, Vincent

    2006-01-01

    The prognosis of patients suffering from WHO grade 3 and 4 astrocytic glioma remains poor despite surgery, radiation therapy and the use of current chemotherapy regimen. Indeed, the median survival of glioblastoma multiforme (WHO grade 4) patients is at best 14.6 month with only 26.5 percents of the patients still alive after 2 years and the median survival of anaplastic astrocytomas (WHO grade 3) is 19.2 month. Recent evidence suggests that the transcription factor NF-kappaB is constitutively expressed in malignant gliomas and that its inhibition by drugs like Sulfasalazine may block the growth of astrocytic tumors in vitro and in experimental models of malignant gliomas. ULg-GBM-04/1 is a prospective, randomized, double blind single-center phase 1–2 study. A total of twenty patients with progressive malignant glioma despite surgery, radiation therapy and a first line of chemotherapy will be recruited and assigned to four dosage regimen of Sulfasalazine. This medication will be taken orally t.i.d. at a daily dose of 1.5–3–4 or 6 g, continuously until complete remission, evidence of progression or drug intolerance. Primary endpoints are drug safety in the setting of malignant gliomas and tumor response as measured according to MacDonald's criteria. An interim analysis of drug safety will be conducted after the inclusion of ten patients. The complete evaluation of primary endpoints will be conducted two years after the enrolment of the last patient or after the death of the last patient should this occur prematurely. The aim of this study is to evaluate the safety and efficacy of Sulfasalazine as a treatment for recurring malignant gliomas. The safety and efficacy of this drug are analyzed as primary endpoints. Overall survival and progression-free survival are secondary endpoint

  9. A prospective, randomised, controlled, double-blind phase I-II clinical trial on the safety of A-Part® Gel as adhesion prophylaxis after major abdominal surgery versus non-treated group

    Directory of Open Access Journals (Sweden)

    Weis Christine

    2010-07-01

    Full Text Available Abstract Background Postoperative adhesions occur when fibrous strands of internal scar tissue bind anatomical structures to one another. The most common cause of intra-abdominal adhesions is previous intra-abdominal surgical intervention. Up to 74% of intestinal obstructions are caused by post surgical adhesions. Although a variety of methods and agents have been investigated to prevent post surgical adhesions, the problem of peritoneal adhesions remains largely unsolved. Materials serving as an adhesion barrier are much needed. Methods/Design This is a prospective, randomised, controlled, patient blinded and observer blinded, single centre phase I-II trial, which evaluates the safety of A-Part® Gel as an adhesion prophylaxis after major abdominal wall surgery, in comparison to an untreated control group. 60 patients undergoing an elective median laparotomy without prior abdominal surgery are randomly allocated into two groups of a 1:1- ratio. Safety parameter and primary endpoint of the study is the occurrence of wound healing impairment or peritonitis within 28 (+10 days after surgery. The frequency of anastomotic leakage within 28 days after operation, occurrence of adverse and serious adverse events during hospital stay up to 3 months and the rate of adhesions along the scar within 3 months are defined as secondary endpoints. After hospital discharge the investigator will examine the enrolled patients at 28 (+10 days and 3 months (±14 days after surgery. Discussion This trial aims to assess, whether the intra-peritoneal application of A-Part® Gel is safe and efficacious in the prevention of post-surgical adhesions after median laparotomy, in comparison to untreated controls. Trial registration NCT00646412

  10. Prognostic role of a comprehensive geriatric assessment on the management of elderly patients with advanced non-small cell lung cancer (NSCLC): a pooled analysis of two prospective phase II trials by the GFPC Group

    Science.gov (United States)

    Le Caer, Hervé; Borget, Isabelle; Corre, Romain; Locher, Chrystele; Raynaud, Christine; Decroisette, Chantal; Berard, Henri; Audigier-Valette, Clarisse; Dujon, Cecile; Auliac, Jean Bernard; Crequit, Jacquy; Monnet, Isabelle; Vergnenegre, Alain

    2017-01-01

    Background The prognostic role of a comprehensive geriatric assessment (CGA) on the management of elderly patients with advanced-stage non-small cell lung cancer (NSCLC) remains to be established. The objective of this analysis was to determine the prognostic role of each CGA domain on overall survival (OS) among elderly patients with advanced-stage NSCLC. Methods We pooled individual data from two prospective, randomized phases II trials in patients over 65 years old with advanced-stage NSCLC, who were considered fit (0405 trial) or no-fit (0505 trial) based on a CGA. Both trials compared first-line chemotherapy followed by second-line erlotinib with the reverse strategy in terms of progression-free survival (PFS) and OS. Factors prognostic of OS were sought by using the Kaplan-Meier method and the log rank test for univariate analysis, and a Cox model for multivariate analysis. Results Analysis performed on 194 patients (mean age: 77 years, male gender: 70%, never- or ex-smokers: 56%) showed, in univariate analysis that performance status (PS), smoking status, Charlson, simplified Charlson, nutritional scores, and a mobility score were prognostics of OS. In multivariate analysis, PS [HR: 1.4 (1.02–1.9), P=0.04] and the Charlson score [HR: 1.46 (1.07–1.99), P=0.02] were independently prognostic of OS, while the nutritional score [HR: 0.69 (0.46–1.04), P=0.07] and the mobility score [HR: 0.25 (0.06–1.01), P=0.06] were close to significance. Conclusions PS and comorbidities appear to be the main predictors of OS in elderly advanced NSCLC patients selected on the basis of CGA. PMID:29268382

  11. Quality of Life in a Prospective, Multicenter Phase 2 Trial of Neoadjuvant Full-Dose Gemcitabine, Oxaliplatin, and Radiation in Patients With Resectable or Borderline Resectable Pancreatic Adenocarcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Serrano, Pablo E. [Department of Surgery, University Health Network, University of Toronto, Toronto, ON (Canada); Herman, Joseph M. [Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Griffith, Kent A.; Zalupski, Mark M. [Center for Cancer Biostatistics, Biostatistics Unit, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan (United States); Kim, Edward J. [Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan (United States); University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan (United States); Bekaii-Saab, Tanios S. [Division of Medical Oncology, Department of Internal Medicine, The Ohio State University Medical Center, Columbus, Ohio (United States); Ben-Josef, Edgar [Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan (United States); University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan (United States); Dawson, Laura A. [Princess Margaret Cancer Center, University Health Network, Toronto, ON (Canada); Ringash, Jolie [Princess Margaret Cancer Center, University Health Network, Toronto, ON (Canada); Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON (Canada); Wei, Alice C., E-mail: alice.wei@uhn.ca [Department of Surgery, University Health Network, University of Toronto, Toronto, ON (Canada); Princess Margaret Cancer Center, University Health Network, Toronto, ON (Canada); Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON (Canada)

    2014-10-01

    Purpose: To determine the health-related quality of life (QOL) during and after neoadjuvant chemoradiation therapy and surgery for patients with pancreatic adenocarcinoma. Methods and Materials: Participants of a prospective, phase 2 multi-institutional trial treated with neoadjuvant chemoradiation followed by surgery completed QOL questionnaires (European Organization for Research and Treatment in Cancer Quality of Life Questionnaire version 3.0 [EORTC-QLQ C30], EORTC-Pancreatic Cancer module [EORTC-PAN 26], and Functional Assessment of Cancer Therapy Hepatobiliary and Pancreatic subscale [FACT-Hep]) at baseline, after 2 cycles of neoadjuvant therapy, after surgery, at 6 months from initiation of therapy, and at 6-month intervals for 2 years. Mean scores were compared with baseline. A change >10% was considered a minimal clinically important difference. Results: Of 71 participants in the trial, 55 were eligible for QOL analysis. Compliance ranged from 32% to 74%. The EORTC-QLQ C30 global QOL did not significantly decline after neoadjuvant therapy, whereas the Functional Assessment of Cancer Therapy global health measure showed a statistically, but not clinically significant decline (−8, P=.02). This was in parallel with deterioration in physical functioning (−14.1, P=.001), increase in diarrhea (+16.7, P=.044), and an improvement in pancreatic pain (−13, P=.01) as per EORTC-PAN 26. Because of poor patient compliance in the nonsurgical group, long-term analysis was performed only from surgically resected participants (n=36). Among those, global QOL returned to baseline levels after 6 months, remaining near baseline through the 24-month visit. Conclusions: The study regimen consisting of 2 cycles of neoadjuvant therapy was completed without a clinically significant QOL deterioration. A transient increase in gastrointestinal symptoms and a decrease in physical functioning were seen after neoadjuvant chemoradiation. In those patients who underwent surgical

  12. Safety and Efficacy of Botulinum Toxin to Preserve Gland Function after Radiotherapy in Patients with Head and Neck Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blinded Phase I Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Afshin Teymoortash

    Full Text Available This prospective, randomized, placebo-controlled, double-blinded phase I clinical trial investigates safety and efficacy of botulinum toxin (BoNT to preserve gland function after radiotherapy in patients with head and neck cancer. Twelve patients with advanced head and neck cancer were injected with BoNT into the submandibular glands prior to primary radiochemotherapy. Six patients received BoNT/A and 6 patients BoNT/A and B, half of each subgroup into their left and the other half into their right gland. As an internal control, sodium chloride was injected into the respective contralateral gland (placebo. For the evaluation of the salivary gland function, technetium pertechnetate salivary gland scintigraphy was performed before and after the end of radiotherapy. BoNT/A and B were well tolerated. Analysis of the scintigraphic data revealed no statistically significant difference between BoNT and placebo regarding the scintigraphic uptake difference (pBoNT/A = 0.84 and pBoNT/A-B = 0.56 for BoNT/A vs. placebo and BoNT/A-B vs. placebo, respectively. We also found no significant difference in treatment between BoNT and placebo in terms of salivary excretion fraction (pBoNT/A = 0.44; pBoNT/A-B = 0.44. This study demonstrates that BoNT can be safely combined with radiochemotherapy. Dosing and timing of BoNT injection should be further investigated for efficacy analysis. Trial Registration German Registry for Clinical Trails DRKS00004595.

  13. Safety and Efficacy of Botulinum Toxin to Preserve Gland Function after Radiotherapy in Patients with Head and Neck Cancer: A Prospective, Randomized, Placebo-Controlled, Double-Blinded Phase I Clinical Trial

    Science.gov (United States)

    Teymoortash, Afshin; Pfestroff, Andreas; Wittig, Andrea; Franke, Nora; Hoch, Stephan; Harnisch, Susanne; Schade-Brittinger, Carmen; Hoeffken, Helmut; Engenhart-Cabillic, Rita; Brugger, Markus; Strauch, Konstantin

    2016-01-01

    This prospective, randomized, placebo-controlled, double-blinded phase I clinical trial investigates safety and efficacy of botulinum toxin (BoNT) to preserve gland function after radiotherapy in patients with head and neck cancer. Twelve patients with advanced head and neck cancer were injected with BoNT into the submandibular glands prior to primary radiochemotherapy. Six patients received BoNT/A and 6 patients BoNT/A and B, half of each subgroup into their left and the other half into their right gland. As an internal control, sodium chloride was injected into the respective contralateral gland (placebo). For the evaluation of the salivary gland function, technetium pertechnetate salivary gland scintigraphy was performed before and after the end of radiotherapy. BoNT/A and B were well tolerated. Analysis of the scintigraphic data revealed no statistically significant difference between BoNT and placebo regarding the scintigraphic uptake difference (pBoNT/A = 0.84 and pBoNT/A-B = 0.56 for BoNT/A vs. placebo and BoNT/A-B vs. placebo, respectively). We also found no significant difference in treatment between BoNT and placebo in terms of salivary excretion fraction (pBoNT/A = 0.44; pBoNT/A-B = 0.44). This study demonstrates that BoNT can be safely combined with radiochemotherapy. Dosing and timing of BoNT injection should be further investigated for efficacy analysis. Trial Registration German Registry for Clinical Trails DRKS00004595 PMID:26991494

  14. A 3-year multicentre randomized controlled trial of etonogestrel- and levonorgestrel-releasing contraceptive implants, with non-randomized matched copper-intrauterine device controls.

    Science.gov (United States)

    Bahamondes, Luis; Brache, Vivian; Meirik, Olav; Ali, Moazzam; Habib, Ndema; Landoulsi, Sihem

    2015-11-01

    Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion, and between implant and intrauterine device (IUD) contraception, in particular complaints possibly related to hormonal contraceptives? The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants, but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken, and little information is available on comparisons of complaints of side effects of implant and copper IUD users. This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement, follow-ups were at 2 weeks, 3 and 6 months, and semi-annually thereafter for 3 years or until pregnancy, removal or expulsion of the implant/IUD occurred. The study took place in family planning clinics in Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent, and 2982 women were enrolled: 1003, 1005 and 974 in the ENG-implant, LNG-implant and IUD groups, respectively; 995, 997 and 971, respectively, were included in the per protocol analysis reported here. ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight

  15. Astronautics summary and prospects

    CERN Document Server

    Kiselev, Anatoly Ivanovich; Menshikov, Valery Alexandrovich

    2003-01-01

    The monograph by A.I.Kiselev, A.A. Medvedev and Y.A.Menshikov, Astronautics: Summary and Prospects, aroused enthusiasm both among experts and the public at large. This is due to the felicitous choice of presentation that combines a simple description of complex space matters with scientificsubstantiation of the sub­ jectmatter described. The wealth of color photos makes the book still more attractive, and it was nominated for an award at the 14th International Moscow Book Fair, being singled out as the "best publication of the book fair". The book's popularity led to a second edition, substantially revised and enlarged. Since the first edition did not sufficiently cover the issues of space impact on ecology and the prospective development of space systems, the authors revised the entire volume, including in it the chapter "Space activity and ecology" and the section "Multi-function space systems". Using the federal monitoring system, now in the phase of system engi­ neering, as an example, the authors consi...

  16. A multicentre, prospective, non-randomized, sequential, open-label trial to demonstrate the bioequivalence between intravenous immunoglobulin new generation (IGNG) and standard IV immunoglobulin (IVIG) in adult patients with primary immunodeficiency (PID).

    Science.gov (United States)

    Viallard, J-F; Brion, J-P; Malphettes, M; Durieu, I; Gardembas, M; Schleinitz, N; Hoarau, C; Lazaro, E; Puget, S

    2017-09-01

    To demonstrate the bioequivalence between 2 intravenous immunoglobulin (IVIG) preparations, TEGELINE ® and ClairYg ® , a ready-to-use 5% IVIG, in primary immunodeficiency (PID). Secondary objectives were to assess the efficacy, safety and pharmacokinetics of ClairYg ® . Twenty-two adult PID patients receiving stable doses of TEGELINE ® (5% lyophilized IVIG) were switched to ClairYg ® for 6 months. ClairYg ® was administered under the same conditions as TEGELINE ® , either every 3 or 4 weeks. The primary endpoint was mean average total IgG trough level at steady state with ClairYg ® versus TEGELINE ® . Clinical efficacy was also assessed in terms of infections and associated events. Bioequivalence was established with a mean average total IgG trough level at steady state being 8.05g/L with TEGELINE ® and 9.17g/L with ClairYg ® (i.e. geometric mean for the difference between ClairYg ® and TEGELINE ® was 1.136; [90% CI: 1.092-1.181] P4-6g/L) throughout the study. No patient was hospitalized for infection or had serious bacterial infections while receiving ClairYg ® . The median annualized infections rate per patient was similar for both products: 4.35 [0; 21.8] for TEGELINE ® and 4.30 [0; 15.1] for ClairYg ® . Infections were less common with higher IgG trough levels (>8.16g/L). ClairYg ® showed good safety, in particular good hepatic and renal tolerance, and did not induce hemolysis. ClairYg ® pharmacokinetics profile was comparable to that of TEGELINE ® . ClairYg ® is safe and effective in the treatment of adult PID. Copyright © 2017 Société Nationale Française de Médecine Interne (SNFMI). Published by Elsevier SAS. All rights reserved.

  17. Prospective evaluation of prognostic factors uPA/PAI-1 in node-negative breast cancer: Phase III NNBC3-Europe trial (AGO, GBG, EORTC-PBG comparing 6 × FEC versus 3 × FEC/3 × Docetaxel

    Directory of Open Access Journals (Sweden)

    von Minckwitz Gunter

    2011-04-01

    Full Text Available Abstract Background Today, more than 70% of patients with primary node-negative breast cancer are cured by local therapy alone. Many patients receive overtreatment by adjuvant chemotherapy due to inadequate risk assessment. So far, few clinical trials have prospectively evaluated tumor biology based prognostic factors. Risk assessment by a biological algorithm including invasion factors urokinase-type plasminogen activator (uPA and its inhibitor plasminogen activator inhibitor type 1 (PAI-1 will assess up to 35-55% of node-negative patients as low-risk and thus avoid chemotherapy. In contrast, a clinical-pathological algorithm will only classify 20-40% of patients as low-risk. High-risk node-negative patients should receive chemotherapy. Anthracycline-based regimens are accepted as a standard, the additional benefit of taxanes remains an open question. Methods/Design The international NNBC3 ("Node Negative Breast Cancer 3-Europe" trial compares biological risk assessment (UP using invasion factors uPA/PAI-1 with a clinical-pathological algorithm (CP. In this trial, the type of risk assessment (CP or UP was chosen upfront by each center for its patients. Fresh frozen tissue was obtained to determine uPA/PAI-1 using an enzyme-linked immunosorbent assay (ELISA. Patients assessed as high-risk were stratified by human epidermal growth factor receptor 2 (HER2 status and then randomised to receive anthracycline-containing chemotherapy 5-Fluorouracil (F/Epirubicin (E/Cyclophosphymide (C or an anthracycline-taxane sequence (FE100C*6 versus FE100C*3 followed by Docetaxel100*3. Discussion In this trial, 4,149 node-negative patients with operable breast cancer from 153 centers in Germany and France were included since 2002. Measurement of uPA/PAI-1 by ELISA was performed with standardised central quality assurance for 2,497 patients (60% from 56 "UP"-centers. The NNBC 3-Europe trial showed that inclusion of patients into a clinical phase III trial is

  18. Prognostic Significance of Carbohydrate Antigen 19-9 in Unresectable Locally Advanced Pancreatic Cancer Treated With Dose-Escalated Intensity Modulated Radiation Therapy and Concurrent Full-Dose Gemcitabine: Analysis of a Prospective Phase 1/2 Dose Escalation Study

    International Nuclear Information System (INIS)

    Vainshtein, Jeffrey M.; Schipper, Matthew; Zalupski, Mark M.; Lawrence, Theodore S.; Abrams, Ross; Francis, Isaac R.; Khan, Gazala; Leslie, William; Ben-Josef, Edgar

    2013-01-01

    Purpose: Although established in the postresection setting, the prognostic value of carbohydrate antigen 19-9 (CA19-9) in unresectable locally advanced pancreatic cancer (LAPC) is less clear. We examined the prognostic utility of CA19-9 in patients with unresectable LAPC treated on a prospective trial of intensity modulated radiation therapy (IMRT) dose escalation with concurrent gemcitabine. Methods and Materials: Forty-six patients with unresectable LAPC were treated at the University of Michigan on a phase 1/2 trial of IMRT dose escalation with concurrent gemcitabine. CA19-9 was obtained at baseline and during routine follow-up. Cox models were used to assess the effect of baseline factors on freedom from local progression (FFLP), distant progression (FFDP), progression-free survival (PFS), and overall survival (OS). Stepwise forward regression was used to build multivariate predictive models for each endpoint. Results: Thirty-eight patients were eligible for the present analysis. On univariate analysis, baseline CA19-9 and age predicted OS, CA19-9 at baseline and 3 months predicted PFS, gross tumor volume (GTV) and black race predicted FFLP, and CA19-9 at 3 months predicted FFDP. On stepwise multivariate regression modeling, baseline CA19-9, age, and female sex predicted OS; baseline CA19-9 and female sex predicted both PFS and FFDP; and GTV predicted FFLP. Patients with baseline CA19-9 ≤90 U/mL had improved OS (median 23.0 vs 11.1 months, HR 2.88, P<.01) and PFS (14.4 vs 7.0 months, HR 3.61, P=.001). CA19-9 progression over 90 U/mL was prognostic for both OS (HR 3.65, P=.001) and PFS (HR 3.04, P=.001), and it was a stronger predictor of death than either local progression (HR 1.46, P=.42) or distant progression (HR 3.31, P=.004). Conclusions: In patients with unresectable LAPC undergoing definitive chemoradiation therapy, baseline CA19-9 was independently prognostic even after established prognostic factors were controlled for, whereas CA19-9 progression

  19. COSMIC: A Regimen of Intensity Modulated Radiation Therapy Plus Dose-Escalated, Raster-Scanned Carbon Ion Boost for Malignant Salivary Gland Tumors: Results of the Prospective Phase 2 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Jensen, Alexandra D., E-mail: alexdjensen@gmx.de [Department of Radiation Oncology, University of Heidelberg, Heidelberg (Germany); Nikoghosyan, Anna V.; Lossner, Karen [Department of Radiation Oncology, University of Heidelberg, Heidelberg (Germany); Haberer, Thomas; Jäkel, Oliver [Heidelberg Ion Beam Therapy Centre, Heidelberg (Germany); Münter, Marc W.; Debus, Jürgen [Department of Radiation Oncology, University of Heidelberg, Heidelberg (Germany)

    2015-09-01

    Purpose: To investigate the effect of intensity modulated radiation therapy (IMRT) and dose-escalated carbon ion (C12) therapy in adenoid cystic carcinoma (ACC) and other malignant salivary gland tumors (MSGTs) of the head and neck. Patients and Methods: COSMIC (combined treatment of malignant salivary gland tumors with intensity modulated radiation therapy and carbon ions) is a prospective phase 2 trial of 24 Gy(RBE) C12 followed by 50 Gy IMRT in patients with pathologically confirmed MSGT. The primary endpoint is mucositis Common Terminology Criteria grade 3; the secondary endpoints are locoregional control (LC), progression-free survival (PFS), overall survival (OS), and toxicity. Toxicity was scored according to the Common Terminology Criteria for Adverse Events version 3; treatment response was scored according to Response Evaluation Criteria in Solid Tumors 1.1. Results: Between July 2010 and August 2011, 54 patients were accrued, and 53 were available for evaluation. The median follow-up time was 42 months; patients with microscopically incomplete resections (R1, n=20), gross residual disease (R2, n=17), and inoperable disease (n=16) were included. Eighty-nine percent of patients had ACC, and 57% had T4 tumors. The most common primary sites were paranasal sinus (34%), submandibular gland, and palate. At the completion of radiation therapy, 26% of patients experienced grade 3 mucositis, and 20 patients reported adverse events of the ear (38%). The most common observed late effects were grade 1 xerostomia (49%), hearing impairment (25%, 2% ipsilateral hearing loss), and adverse events of the eye (20%), but no visual impairment or loss of vision. Grade 1 central nervous system necrosis occurred in 6%, and 1 grade 4 ICA hemorrhage without neurologic sequelae. The best response was 54% (complete response/partial remission). At 3 years, the LC, PFS, and OS were 81.9%, 57.9%, and 78.4%, respectively. No difference was found regarding resection status. The

  20. Uranium project. Geochemistry prospection

    International Nuclear Information System (INIS)

    Lambert, J.

    1983-01-01

    Geochemistry studies the distribution of the chemicals elements in the terrestrial crust and its ways to migrate. The terminology used in this report is the following one: 1) Principles of the prospection geochemistry 2) Stages of the prospection geochemistry 3)utility of the prospection geochemistry 4) geochemistry of uranium 5) procedures used within the framework of uranium project 6) Average available 7) Selection of the zones of prospection geochemistry 8) Stages of the prospection, Sample preparation and analisis 9) Presentation of the results

  1. Safety, Biodistribution, and Radiation Dosimetry of68Ga-OPS202 (68Ga-NODAGA-JR11) in Patients with Gastroenteropancreatic Neuroendocrine Tumors: A Prospective Phase I Imaging Study.

    Science.gov (United States)

    Nicolas, Guillaume P; Beykan, Seval; Bouterfa, Hakim; Kaufmann, Jens; Bauman, Andreas; Lassmann, Michael; Reubi, Jean Claude; Rivier, Jean E F; Maecke, Helmut R; Fani, Melpomeni; Wild, Damian

    2017-10-12

    Preclinical and preliminary clinical evidence indicates that radiolabeled somatostatin receptor (sst) antagonists perform better than agonists in terms of detecting neuroendocrine tumors (NETs). This prospective phase I/II study is the first to evaluate an sst antagonist, 68 Ga-OPS202 ( 68 Ga-NODAGA-JR11; NODAGA=1,4,7-triazacyclononane,1-glutaric acid-4,7-acetic acid and JR11=Cpa-c(DCys-Aph(Hor)-DAph(Cbm)-Lys-Thr-Cys)-DTyr-NH 2 )) for PET imaging. Here, we report results of the phase I component of the study. Methods: Patients received two single intravenous injections of 150 MBq 68 Ga-OPS202 three to 4 weeks apart (15 µg peptide at visit 1 and 50 µg at visit 2). At visit 1, a dynamic PET/CT scan was performed over the kidney during the first 30 min post-injection and static whole-body scans at 0.5, 1, 2, and 4 h p.i; at visit 2, a static whole-body scan was performed at 1 h. Blood samples and urine were collected at regular intervals to determine 68 Ga-OPS202 pharmacokinetics. Safety, biodistribution, radiation dosimetry, and the most appropriate imaging time-point for 68 Ga-OPS202 were assessed. Results: Twelve patients with well-differentiated gastroenteropancreatic (GEP) NETs took part in the study. 68 Ga-OPS202 rapidly cleared from the blood; the mean residence time in the blood was 2.4 ± 1.1 min/L. The organs with the highest mean dose coefficients were the urinary bladder wall, kidneys, and spleen. The calculated effective dose was 2.4E-02 ± 0.2E-02 mSv/MBq, corresponding to 3.6 mSv for a reference activity of 150 MBq. Based on total numbers of detected malignant lesions, the optimal time window for the scan was between 1 and 2 h. For malignant liver lesions, the time point at which most patients had the highest mean tumor contrast was 1 h. 68 Ga-OPS202 was well tolerated; adverse events were grade 1 or 2 and there were no signals of concern for laboratory blood or urinalysis tests. Conclusion: 68 Ga-OPS202 shows favorable biodistribution and imaging

  2. Gemcitabine alone or with cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic carcinoma: a prospective, randomized phase III study of the Gruppo Oncologia dell'Italia Meridionale.

    Science.gov (United States)

    Colucci, Giuseppe; Giuliani, Francesco; Gebbia, Vittorio; Biglietto, Maria; Rabitti, Piergiorgio; Uomo, Generoso; Cigolari, Silvio; Testa, Antonio; Maiello, Evaristo; Lopez, Massimo

    2002-02-15

    A prospective, randomized Phase III trial was performed to determine whether, compared with gemcitabine (GEM) alone, the addition of cisplatin (CDDP) to GEM was able to improve the time to disease progression and the clinical benefit rate in patients with advanced pancreatic adenocarcinoma. The objective response rate, overall survival rate, and toxicity patterns of patients in the two treatment arms were evaluated as secondary end points. Patients with measurable, locally advanced and/or metastatic pancreatic adenocarcinoma were randomized to receive GEM (Arm A) or a combination of GEM and CDDP (Arm B). In Arm A, a dose of 1000 mg/m(2) GEM per week was administered for 7 consecutive weeks, and, after a 2-week rest, treatment was resumed on Days 1, 8, and 15 of a 28-day cycle for 2 cycles. In Arm B, CDDP was given at a dose of 25 mg/m(2) per week 1 hour before GEM at the same dose that was used in Arm A. On Day 22, only GEM was administered. Patients were restaged after the first 7 weeks of therapy and then again after the other 2 cycles. A total of 107 patients entered the trial: Fifty-four patients were randomized to Arm A, and 53 patients were randomized to Arm B. The median time to disease progression was 8 weeks in Arm A and 20 weeks in Arm B; this difference was statistically significant (P = 0.048). In Arm A, one complete response and four partial responses were recorded on the basis of an intent-to-treat analysis, with an overall response rate of 9.2% (95% confidence interval [95%CI], 3-20%). In Arm B, there were no complete responses, whereas 14 partial responses were achieved, with an overall response rate of 26.4% (95%CI, 15-40%). This difference in the overall response rates was statistically significant (P = 0.02). The tumor growth control rate (i.e., total number of patients who achieved complete responses, partial responses, and stable disease) was 42.6% (95%CI, 29-57%) in Arm A and 56.6% (95%CI, 42-70%) in Arm B. A clinical benefit was observed in

  3. AgroSun. Outline of the prospect of solar PV as a structural chance for the agricultural sector [in the Netherlands]. Phase 1. Inventory, cost effectiveness and benchmark; AgroSun. Verkenning van de kansrijkheid van zon PV als structurele kans voor de agrarische sector. Fase 1. Inventarisatie, rentabiliteit en benchmark

    Energy Technology Data Exchange (ETDEWEB)

    Lemmens, P. [Arvalis Projecten, Roermond (Netherlands); Buiter, W. [ZLTO Advies, Den Bosch (Netherlands); Veefkind, W. [Projecten LTO Noord, Zwolle (Netherlands)

    2011-12-15

    An overview is given of the opportunities of solar PV for the agricultural sector. Attention is paid to the technology, the market, technical indicators, economic aspects of solar panels, policy frameworks and subsidies, practical applications, future prospects, and alternative financing. Also conclusions and recommendations are given for the follow-up phase [Dutch] Dit rapport inventariseert de kansen die zon-pv biedt aan de agrarische sector. Achtereenvolgens: de technologie, de markt, technische kengetallen, economische aspecten van zonnepanelen, beleidsmatige kaders en subsidieregelingen, praktijktoepassingen, het toekomstperspectief en alternatieve financiering. Met conclusies en aanbevelingen voor een vervolgfase.

  4. Geochemical prospecting in Guiana

    International Nuclear Information System (INIS)

    Coulomb, R.

    1957-01-01

    During the last few years geochemical prospecting techniques have become common usage in the field of mineral deposit prospecting. The real scope of these methods lies in their use in the prospecting of large areas. The most promising use of the geochemistry and hydro-geochemistry of uranium is in heavily forested tropical territories, with few outcrops, where radiometry is strongly handicapped. (author) [fr

  5. Endogenous Prospect Theory

    OpenAIRE

    Schmidt, Ulrich; Zank, Horst

    2010-01-01

    In previous models of (cumulative) prospect theory reference-dependence of preferences is imposed beforehand and the location of the reference point is exogenously determined. This paper provides an axiomatization of a new specification of cumulative prospect theory, termed endogenous prospect theory, where reference-dependence is derived from preference conditions and a unique reference point arises endogenously.

  6. Effect of regulating airway pressure on intrathoracic pressure and vital organ perfusion pressure during cardiopulmonary resuscitation: a non-randomized interventional cross-over study.

    Science.gov (United States)

    Kwon, Younghoon; Debaty, Guillaume; Puertas, Laura; Metzger, Anja; Rees, Jennifer; McKnite, Scott; Yannopoulos, Demetris; Lurie, Keith

    2015-10-28

    The objective of this investigation was to evaluate changes in intrathoracic pressure (Ppl), airway pressure (Paw) and vital organ perfusion pressures during standard and intrathoracic pressure regulation (IPR)-assisted cardiopulmonary resuscitation (CPR). Multiple CPR interventions were assessed, including newer ones based upon IPR, a therapy that enhances negative intrathoracic pressure after each positive pressure breath. Eight anesthetized pigs underwent 4 min of untreated ventricular fibrillation followed by 2 min each of sequential interventions: (1) conventional standard CPR (STD), (2) automated active compression decompression (ACD) CPR, (3) ACD+ an impedance threshold device (ITD) CPR or (4) ACD+ an intrathoracic pressure regulator (ITPR) CPR, the latter two representing IPR-based CPR therapies. Intrapleural (Ppl), airway (Paw), right atrial, intracranial, and aortic pressures, along with carotid blood flow and end tidal CO2, were measured and compared during each CPR intervention. The lowest mean and decompression phase Ppl were observed with IPR-based therapies [Ppl mean (mean ± SE): STD (0.8 ± 1.1 mmHg); ACD (-1.6 ± 1.6); ACD-ITD (-3.7 ± 1.5, p ACD); ACD-ITPR (-7.0 ± 1.9, p ACD)] [Ppl decompression (mean ± SE): STD (-6.3 ± 2.2); ACD (-13.0 ± 3.8); ACD-ITD -16.9 ± 3.6, p ACD); ACD-ITPR -18.7 ± 3.5, p ACD)]. Interventions with the lower mean or decompression phase Ppl also demonstrated lower Paw and were associated with higher vital organ perfusion pressures. IPR-based CPR methods, specifically ACD-ITPR, yielded the most pronounced reduction in both Ppl and Paw and resulted in the most favorable augmentation of hemodynamics during CPR.

  7. Phase I/II trial of vorinostat (SAHA) and erlotinib for non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations after erlotinib progression.

    Science.gov (United States)

    Reguart, Noemi; Rosell, Rafael; Cardenal, Felipe; Cardona, Andres F; Isla, Dolores; Palmero, Ramon; Moran, Teresa; Rolfo, Christian; Pallarès, M Cinta; Insa, Amelia; Carcereny, Enric; Majem, Margarita; De Castro, Javier; Queralt, Cristina; Molina, Miguel A; Taron, Miquel

    2014-05-01

    Vorinostat or suberoylanilide hydroxamic acid (SAHA) is a novel histone deacetylase inhibitor with demonstrated antiproliferative effects due to drug-induced accumulation of acetylated proteins, including the heat shock protein 90. We prospectively studied the activity of vorinostat plus erlotinib in EGFR-mutated NSCLC patients with progression to tyrosine kinase inhibitors. We conducted this prospective, non-randomized, multicenter, phase I/II trial to evaluate the maximum tolerated dose, toxicity profile and efficacy of erlotinib and vorinostat. Patients with advanced NSCLC harboring EGFR mutations and progressive disease after a minimum of 12 weeks on erlotinib were included. The maximum tolerated dose of vorinostat plus erlotinib was used as recommended dose for the phase II (RDP2) to assess the efficacy of the combination. The primary end point was progression-free-survival rate at 12 weeks (PFSR12w). Pre-treatment plasma samples were required to assess T790M resistant mutation. A total of 33 patients were enrolled in the phase I-II trial. The maximum tolerated dose was erlotinib 150 mg p.o., QD, and 400mg p.o., QD, on days 1-7 and 15-21 in a 28-day cycle. Among the 25 patients treated at the RDP2, the most common toxicities included anemia, fatigue and diarrhea. No responses were observed. PFSR12w was 28% (IC 95%: 18.0-37.2); median progression-free survival (PFS) was 8 weeks (IC 95%: 7.43-8.45) and overall survival (OS) 10.3 months (95% CI: 2.4-18.1). Full dose of continuous erlotinib with vorinostat 400mg p.o., QD on alternative weeks can be safely administered. Still, the combination has no meaningful activity in EGFR-mutated NSCLC patients after TKI progression. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  8. A multicenter, non-randomized, phase II study of docetaxel and carboplatin administered every 3 weeks as second line chemotherapy in patients with first relapse of platinum sensitive epithelial ovarian, peritoneal or fallopian tube cancer

    DEFF Research Database (Denmark)

    Wang, Yun; Herrstedt, Jørn; Havsteen, Hanne

    2014-01-01

    of 398 cycles were given. Grade 3/4 neutropenia was seen in 80% (59 of 74) patients with an incidence of febrile neutropenia of 16%. Grade 2/3 sensory peripheral neuropathy occurred in 7% of patients, but no grade 4 sensory peripheral neuropathy was observed. Sixty patients were evaluable for response...... and repeated every 3 weeks for 6-9 courses. Primary endpoint was toxicity; secondary endpoints were response rate and the time to progression. RESULTS: A total of 74 patients were included. Of these, 50 patients received 6 or more cycles, 13 received 3-5 courses and 11 received less than 3 courses. A total...

  9. Psychophysiology of prospective memory.

    Science.gov (United States)

    Rothen, Nicolas; Meier, Beat

    2014-01-01

    Prospective memory involves the self-initiated retrieval of an intention upon an appropriate retrieval cue. Cue identification can be considered as an orienting reaction and may thus trigger a psychophysiological response. Here we present two experiments in which skin conductance responses (SCRs) elicited by prospective memory cues were compared to SCRs elicited by aversive stimuli to test whether a single prospective memory cue triggers a similar SCR as an aversive stimulus. In Experiment 2 we also assessed whether cue specificity had a differential influence on prospective memory performance and on SCRs. We found that detecting a single prospective memory cue is as likely to elicit a SCR as an aversive stimulus. Missed prospective memory cues also elicited SCRs. On a behavioural level, specific intentions led to better prospective memory performance. However, on a psychophysiological level specificity had no influence. More generally, the results indicate reliable SCRs for prospective memory cues and point to psychophysiological measures as valuable approach, which offers a new way to study one-off prospective memory tasks. Moreover, the findings are consistent with a theory that posits multiple prospective memory retrieval stages.

  10. A Non-randomized Comparison of Strategies for Consultation in a Community-Academic Training Program to Implement an Evidence-Based Psychotherapy.

    Science.gov (United States)

    Stirman, Shannon Wiltsey; Pontoski, Kristin; Creed, Torrey; Xhezo, Regina; Evans, Arthur C; Beck, Aaron T; Crits-Christoph, Paul

    2017-01-01

    Despite the central role of training and consultation in the implementation of evidence-based psychological interventions (EBPIs), comprehensive reviews of research on training have highlighted serious gaps in knowledge regarding best practices. Consultation after initial didactic training appears to be of critical importance, but there has been very little research to determine optimal consultation format or interventions. This observational study compared two consultation formats that included review of session audio and feedback in the context of a program to train clinicians (n = 85) in community mental health clinics to deliver cognitive therapy (CT). A "gold standard" condition in which clinicians received individual feedback after expert consultants reviewed full sessions was compared to a group consultation format in which short segments of session audio were reviewed by a group of clinicians and an expert consultant. After adjusting for potential baseline differences between individuals in the two consultation conditions, few differences were found in terms of successful completion of the consultation phase or in terms of competence in CT at the end of consultation or after a 2 year follow-up. However, analyses did not support hypotheses regarding non-inferiority of the group consultation condition. While both groups largely maintained competence, clinicians in the group consultation condition demonstrated increases in competence over the follow-up period, while a sub-group of those in the individual condition experienced decreases. These findings, if replicated, have important implications for EBP implementation programs, as they suggest that observation and feedback is feasible in community mental health setting, and that employing this method in a group format is an effective and efficient consultation strategy that may enhance the implementation and sustainability of evidence-based psychotherapies.

  11. Prospective tracking of a pediatric emergency department e-kiosk to deliver asthma education.

    Science.gov (United States)

    Joshi, Ashish; Weng, Wenjing; Lichenstein, Richard; Arora, Mohit; Sears, Andrew

    2009-12-01

    The study objective was to describe the prospective use of an interactive Patient Education and Motivation Tool (PEMT) placed within a pediatric emergency department (ED). A touch screen computer was utilized to deliver asthma education to children and their parents/guardians during their acute asthma visit between November 2006 and April 2007. Ninety-nine participants were enrolled in this prospective non-randomized pre-post study. PEMT comprised three key components: screening, learning and evaluation. The tool tracked the date the system was used, user characteristics, asthma knowledge, amount of time spent on each screen, and navigational patterns of individuals using the program. The results showed that baseline asthma knowledge had positive association with age and negative association with time spent in the learning module. There was negative association between age and time spent in the learning module. Thus PEMT was effective in improving the asthma knowledge of young patients and those having lower baseline knowledge.

  12. 1,500 IU human chorionic gonadotropin administered at oocyte retrieval rescues the luteal phase when gonadotropin-releasing hormone agonist is used for ovulation induction: a prospective, randomized, controlled study

    DEFF Research Database (Denmark)

    Al Humaidan, Peter Samir Heskjær; Ejdrup Bredkjaer, Helle; Westergaard, Lars Grabow

    2010-01-01

    OBJECTIVE: To prospectively assess the reproductive outcome with a small bolus of hCG administered on the day of oocyte retrieval after ovulation induction with a GnRH agonist (GnRHa). DESIGN: Prospective, randomized trial. SETTING: Three hospital-based IVF clinics. PATIENT(S): Three hundred five...... IVF/intracytoplasmic sperm injection patients after a GnRH antagonist protocol. INTERVENTION(S): Ovulation induction was performed with either 10,000 IU hCG or 0.5 mg GnRHa (buserelin) supplemented with 1,500 IU hCG on the day of oocyte retrieval. MAIN OUTCOME MEASURE(S): Reproductive outcome...... in the two groups. RESULT(S): No significant differences were seen regarding positive hCG/ET rate (48% and 48%), ongoing pregnancy rate (26% and 33%), delivery rate (24% and 31%), and rate of early pregnancy loss (21% and 17%) between the GnRHa and 10,000 IU hCG groups, respectively. CONCLUSION(S): A small...

  13. 'I-tese newsletter Number 15 Spring 2012: an assessment of the 'phasing-out-nuclear cost' in France; Prospective: a posture in the service of man to help him in shaping the future; Climate in UNO: heading for a new multilateral agreement?; Electric mobility with fuel cell: which target price(s) for hydrogen at the pump? Does the 'real production cost' of the present electronuclear fleet exist?

    International Nuclear Information System (INIS)

    Dautremont, Severine; Devezeaux de Lavergne, Jean-Guy; Colle, Francois Xavier; Popiolek, Nathalie; Thais, Francoise; Le Duigou, Alain; Duquesnoy, Thierry; Sabourin, Didier

    2011-01-01

    Based on the definition of two scenarios (a reference scenario with a steady power, and phasing out nuclear), a first article discusses the assessment of the cost of phasing out nuclear for France. A second article comments the importance given to prospective studies which more particularly emerged in the United States after World War II. This article is followed by another one which addresses the peculiar case of energetic prospective studies which can be perceived as a battle of scenarios. An article discusses the need of a new agreement on climate after the Durban conference. The next article discusses how to characterize the competitiveness of hydrogen used in fuel cells in the transport sector. Then, an author comments a report by the French Revenue Court about the initial investment costs of the electronuclear fleet, present operation expenses, maintenance costs and provisions for future expenses

  14. CANDU market prospects

    International Nuclear Information System (INIS)

    Kakaria, B.K.

    1994-01-01

    This 1994 survey of prospective markets for CANDU reactors discusses prospects in Turkey, Thailand, the Philippines, Korea, Indonesia, China and Egypt, and other opportunities, such as in fuel cycles and nuclear safety. It was concluded that foreign partners would be needed to help with financing

  15. Phase II trial of temozolomide for leptomeningeal metastases in patients with solid tumors.

    Science.gov (United States)

    Segura, Pedro Pérez; Gil, Miguel; Balañá, Carmen; Chacón, Ignacio; Langa, José Muñoz; Martín, María; Bruna, Jordi

    2012-08-01

    There is a current unmet medical need for treatment of leptomeningeal metastases (LMD). To analyze the efficacy and safety of systemic temozolomide (TMZ) for first-line treatment of patients with LMD associated with solid tumors, a phase II, non-randomized, multicenter, prospective study was conducted. The planned duration of treatment was a maximum of six cycles (24 weeks) or until unacceptable toxicity was reported. One cycle of oral TMZ (100 mg/m(2) daily) consisted of one week on treatment/one week off treatment for four weeks. The study was stopped early because of poor accrual. Nineteen patients (median age 51(33-72); 32 % male) were enrolled. The LMD source was breast cancer (53 %) and non-small-cell lung cancer (37 %). Previous treatment was chemotherapy (100 %), surgery 74 %, radiotherapy 79 %, and hormone therapy 42 %. The average last dose of TMZ received by patients was 171 mg and only one patient required dose reduction. Three of 19 patients (15.8 %) had clinical benefit and 16 of 19 patients (84.2 %) progressed. Of the two patients completing the study (six cycles, 24 weeks), one had a partial response and the other stable disease. Median survival was 43 days (95 % CI 28.7-57.3); there were 18 deaths. Median TTP was 28 days (95 % CI 14-42). The most common adverse event was vomiting (52.6 %); nine patients (47.4 %) reported at least one serious adverse event but only one episode of thrombocytopenia was drug related. Median Karnofsky score remained at or above 70 % throughout the study, and was 75 % at the end of the study. First-line TMZ was well tolerated, and did not adversely affect the quality of life of patients with LMD. Future studies are needed to verify the efficacy results of this pilot trial.

  16. Prospective memory in adults with traumatic brain injury: an analysis of perceived reasons for remembering and forgetting.

    Science.gov (United States)

    Roche, Nadine L; Moody, Anna; Szabo, Krisztina; Fleming, Jennifer M; Shum, David H K

    2007-06-01

    Reasons for prospective remembering and forgetting after traumatic brain injury (TBI) were investigated using Ellis' (1996) five phases of prospective memory as a framework. Participants were 38 individuals with severe TBI and 34 controls. Participants self-rated their perceived reasons for prospective remembering and forgetting using section C of the Comprehensive Assessment of Prospective Memory (CAPM). Significant others also rated participants using the same scale. Analyses were conducted to examine the effect of group membership (TBI or control) on reported reasons for prospective remembering and forgetting. Findings highlighted the TBI group's difficulties with encoding, performance interval, and execution phases of prospective remembering.

  17. Class separation of lipids and polycyclic aromatic hydrocarbons in normal phase high performance liquid chromatography - a prospect for analysis of aromatics in edible vegetable oils and biodiesel exhaust particulates.

    Science.gov (United States)

    Olsson, Petter; Sadiktsis, Ioannis; Holmbäck, Jan; Westerholm, Roger

    2014-09-19

    The retention characteristics of the major lipid components in biodiesels and edible oils as well as representative polycyclic aromatic compounds (PAHs) have been investigated on five different normal phase HPLC stationary phases, in order to optimize class separation for an automatized online HPLC cleanup of PAHs prior GC-MS analysis. By stepwise comparison of different hexane/MTBE compositions as mobile phases on cyano-, phenyl-, pentabromobenzyl-, nitrophenyl- and amino-modified silica columns, the capacity and selectivity factors for each analyte and column could be calculated. It was concluded that the most suitable column for backflush isolation of PAHs in biodiesel and edible oil matrices was the pentabromobenzyl-modified silica (PBB). A previously described online HPLC-GC-MS system using the PBB column was then evaluated by qualitative and quantitative analysis of a biodiesel exhaust particulate extract and a vegetable oil reference material. The GC-MS full scan analysis of the biodiesel particulate extract showed that the lipids had been removed from the sample and a fraction containing PAHs and oxygenated derivatives thereof had been isolated. Quantified mass fractions of PAHs of the reference material BCR-458 agreed well for most of the certified PAH mass fractions in the spiked coconut oil reference material. Copyright © 2014 Elsevier B.V. All rights reserved.

  18. Perceiving prospects properly

    Czech Academy of Sciences Publication Activity Database

    Steiner, Jakub; Stewart, C.

    2016-01-01

    Roč. 106, č. 7 (2016), s. 1601-1631 ISSN 0002-8282 Institutional support: RVO:67985998 Keywords : evolution * perception bias * prospect theory Subject RIV: AH - Economics Impact factor: 4.026, year: 2016

  19. Challenges and Prospects

    African Journals Online (AJOL)

    Erah

    Finally, the prospective areas for biopharmaceutical innovation in Africa include research and development, marketing, workforce development and contract manufacturing. Keywords: Small and Medium Sized Enterprises, SMEs, Biopharmaceuticals, Research and. Development, Contract manufacturing. Received: 30 May ...

  20. Safety and immunogenicity of an inactivated cell culture-derived H7N9 influenza vaccine in healthy adults: A phase I/II, prospective, randomized, open-label trial.

    Science.gov (United States)

    Wu, Un-In; Hsieh, Szu-Min; Lee, Wen-Sen; Wang, Ning-Chi; Kung, Hsiang-Chi; Ou, Tsong-Yih; Chen, Fu-Lun; Lin, Te-Yu; Chen, Yee-Chun; Chang, Shan-Chwen

    2017-07-24

    We conducted a phase I/II clinical trial to evaluate the safety and immunogenicity of a Madin-Darby canine kidney (MDCK) cell-grown inactivated H7N9 influenza vaccine for pandemic preparedness purposes. Between April 7, 2015 and May 27, 2016, healthy adults aged 20-60years were enrolled sequentially in phase I (n=40) and phase II (n=160) from three hospitals in Taiwan and randomized to receive 2 doses of whole-virus H7N9 vaccine (15 or 30μg hemagglutinin antigen (HA) with or without an aluminum hydroxide adjuvant) at 21-day intervals. Safety up to 180days and changes in hemagglutinin inhibition (HI) titers at 21days after each vaccination were determined. Of the 200 randomized subjects, 193 (96.5%) received 2 doses of the study vaccine and were included in the intention-to-treat analysis for safety, and 190 (95%) were included in the per-protocol analysis for immunogenicity. Most adverse events were mild and transient; no death or vaccine-related serious adverse events were reported. Overall, higher immune responses were observed in the groups administered with 30μgHA formulation than in the other two groups administered with 15μgHA formulation. The highest immune response was observed in subjects who received 2 doses of the adjuvanted vaccine containing 30μgHA with HI titer, seroprotection rate, seroconversion rate, and seroconversion factor of 36.2, 64.6%, 64.6% and 5.7, respectively. Our study demonstrated that the H7N9 influenza vaccine containing 30µgHA with aluminum hydroxide adjuvant was immunogenic and safe in adults aged 20-60years. CLINICALTRIALS.GOV identifier: NCT02436928. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. Interventions for physical activity promotion applied to the primary healthcare settings for people living in regions of low socioeconomic level: study protocol for a non-randomized controlled trial.

    Science.gov (United States)

    Salvador, Emanuel P; Ribeiro, Evelyn H; Garcia, Leandro Mt; Andrade, Douglas R; Guimaraes, Vanessa Mv; Aoki, Marcelo S; Florindo, Alex A

    2014-03-13

    Regular physical activity practice has been widely recommended for promoting health, but the physical activity levels remain low in the population. Therefore, the study of interventions to promote physical activity is essential. To present the methodology of two physical activity interventions from the "Ambiente Ativo" ("Active Environment") project. 12-month non-randomized controlled intervention trial. 157 healthy and physically inactive individuals were selected: health education (n = 54) supervised exercise (n = 54) and control (n = 49). Intervention based on health education: a multidisciplinary team of health professionals organized the intervention in group discussions, phone calls, SMS and educational material. Intervention based on supervised exercise program: consisted of offering an exercise program in groups supervised by physical education professionals involving strength, endurance and flexibility exercises. The physical activity level was assessed by the International Physical Activity Questionnaire (long version), physical activities recalls, pedometers and accelerometers over a seven-day period. This study described two different proposals for promoting physical activity that were applied to adults attended through the public healthcare settings. The participants were living in a region of low socioeconomic level, while respecting the characteristics and organization of the system and its professionals, and also adapting the interventions to the realities of the individuals attended. Both interventions are applicable in regions of low socioeconomic level, while respecting the social and economic characteristics of each region. ClinicalTrials.gov NCT01852981.

  2. RANDOMNESS of Numbers DEFINITION(QUERY:WHAT? V HOW?) ONLY Via MAXWELL-BOLTZMANN CLASSICAL-Statistics(MBCS) Hot-Plasma VS. Digits-Clumping Log-Law NON-Randomness Inversion ONLY BOSE-EINSTEIN QUANTUM-Statistics(BEQS) .

    Science.gov (United States)

    Siegel, Z.; Siegel, Edward Carl-Ludwig

    2011-03-01

    RANDOMNESS of Numbers cognitive-semantics DEFINITION VIA Cognition QUERY: WHAT???, NOT HOW?) VS. computer-``science" mindLESS number-crunching (Harrel-Sipser-...) algorithmics Goldreich "PSEUDO-randomness"[Not.AMS(02)] mea-culpa is ONLY via MAXWELL-BOLTZMANN CLASSICAL-STATISTICS(NOT FDQS!!!) "hot-plasma" REPULSION VERSUS Newcomb(1881)-Weyl(1914;1916)-Benford(1938) "NeWBe" logarithmic-law digit-CLUMPING/ CLUSTERING NON-Randomness simple Siegel[AMS Joint.Mtg.(02)-Abs. # 973-60-124] algebraic-inversion to THE QUANTUM and ONLY BEQS preferentially SEQUENTIALLY lower-DIGITS CLUMPING/CLUSTERING with d = 0 BEC, is ONLY VIA Siegel-Baez FUZZYICS=CATEGORYICS (SON OF TRIZ)/"Category-Semantics"(C-S), latter intersection/union of Lawvere(1964)-Siegel(1964)] category-theory (matrix: MORPHISMS V FUNCTORS) "+" cognitive-semantics'' (matrix: ANTONYMS V SYNONYMS) yields Siegel-Baez FUZZYICS=CATEGORYICS/C-S tabular list-format matrix truth-table analytics: MBCS RANDOMNESS TRUTH/EMET!!!

  3. A non-randomized confirmatory trial of segmentectomy for clinical T1N0 lung cancer with dominant ground glass opacity based on thin-section computed tomography (JCOG1211).

    Science.gov (United States)

    Aokage, Keiju; Saji, Hisashi; Suzuki, Kenji; Mizutani, Tomonori; Katayama, Hiroshi; Shibata, Taro; Watanabe, Syunichi; Asamura, Hisao

    2017-05-01

    Lobectomy has been the standard surgery for even stage I lung cancer since the validity of limited resection for stage I lung cancer was denied by the randomized study reported in 1995. The aim of this non-randomized confirmatory going on since September 2013 is to confirm the efficacy of a segmentectomy for clinical T1N0 lung cancer with dominant ground glass opacity based on thin-slice computed tomography. A total of 390 patients from 42 Japanese institutions are recruited within 4 years. The primary endpoint of this study is a 5-year relapse-free survival in all of the patients who undergo a segmentectomy for a lung nodule. The secondary endpoints are overall survival, annual relapse-free survival, disease-free survival, proportion of local relapse, postoperative pulmonary function, proportion of segmentectomy completion, proportion of R0 resection completion by segmentectomy, adverse events, and serious adverse events. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000011819 ( http://www.umin.ac.jp/ctr/ ). Patient's accrual has been already finished in November, 2015 and the primary analysis will be performed in 2021. This study is one of the pivotal trial of lung segmentectomy for early lung cancer. The result will provide a clear evidence for our daily clinics and will be possible contribution to preserving pulmonary function for lung cancer patients.

  4. Complex Systems Analysis of Cell Cycling Models in Carcinogenesis:II. Cell Genome and Interactome, Neoplastic Non-random Transformation Models in Topoi with Lukasiewicz-Logic and MV Algebras

    CERN Document Server

    Baianu, I C

    2004-01-01

    Quantitative Biology, abstract q-bio.OT/0406045 From: I.C. Baianu Dr. [view email] Date (v1): Thu, 24 Jun 2004 02:45:13 GMT (164kb) Date (revised v2): Fri, 2 Jul 2004 00:58:06 GMT (160kb) Complex Systems Analysis of Cell Cycling Models in Carcinogenesis: II. Authors: I.C. Baianu Comments: 23 pages, 1 Figure Report-no: CC04 Subj-class: Other Carcinogenesis is a complex process that involves dynamically inter-connected modular sub-networks that evolve under the influence of micro-environmentally induced perturbations, in non-random, pseudo-Markov chain processes. An appropriate n-stage model of carcinogenesis involves therefore n-valued Logic treatments of nonlinear dynamic transformations of complex functional genomes and cell interactomes. Lukasiewicz Algebraic Logic models of genetic networks and signaling pathways in cells are formulated in terms of nonlinear dynamic systems with n-state components that allow for the generalization of previous, Boolean or "fuzzy", logic models of genetic activities in vivo....

  5. The study protocol for a non-randomized controlled clinical trial using a genotype-guided strategy in a dataset of patients who undergone percutaneous coronary intervention with stent.

    Science.gov (United States)

    Dávila-Fajardo, Cristina Lucía; Sánchez-Ramos, Jesús; Villamarín, Xando Diaz-; Martínez-González, Luis Javier; Frías, Pablo Toledo; Huertas, Susana Martínez; Gómez, Francisco Burillo; Borrego, Juan Caballero; Pavés, Alicia Bautista; Guzmán, Mª Carmen Marín; Hernández, José Antonio Ramirez; Vilches, Concepción Correa; Barrera, Jose Cabeza

    2017-02-01

    This article contains data related to the research article entitled "Results of genotype-guided antiplatelet therapy in patients undergone percutaneous coronary intervention with stent" (J. Sánchez-Ramos, C.L. Dávila-Fajardo, P. Toledo Frías, X. Díaz Villamarín, L.J. Martínez-González, S. Martínez Huertas, F. Burillo Gómez, J. Caballero Borrego, A. Bautista Pavés, M.C. Marín Guzmán, J.A. Ramirez Hernández, C. Correa Vilches, J. Cabeza Barrera, 2016) (1). This data article reports, for the first time, about the non-randomized clinical trial protocol that check if CYP2C19/ABCB1 genotype-guided strategy in which the choice of antiplatelet therapy is based on the genetic test, reduces the rates of cardiovascular events and bleeding compared to a non-tailored strategy in patients undergone percutaneous coronary intervention (PCI) with stent. The data included in this article are: design and setting of the study, study population, inclusion and exclusion criteria, definition of the intervention, objectives, variables (baseline characteristics and during the follow-up), study procedures, collection and treatment of the biological sample, genotyping, withdrawal criteria, sample size, statistic analysis, ethical aspects, information sheet and consent form. The authors confirm that this study has been registered in Eudra CT (Eudra CT: 2016-001294-33).

  6. Competitive natural gas market situation and prospects

    International Nuclear Information System (INIS)

    Cazzola, C.; Grillo, M.

    1998-01-01

    This article evaluates the prospects for achieving a competitive market in the natural gas industry, according to the common rules for the internal market established by the Directive 98/30/CE of 22 June 1998. Firstly, for the organisation of the access to the system, the regulated, rather than the negotiated, procedure would ensure a better opportunity to promote competition in the market. Secondly, the establishment of a competitive market calls for the effective separation of the phases of production characterized by natural monopoly from the phases which may be developed in a competitive setting [it

  7. Late gastrointestinal and urogenital side-effects after radiotherapy – Incidence and prevalence. Subgroup-analysis within the prospective Austrian–German phase II multicenter trial for localized prostate cancer

    International Nuclear Information System (INIS)

    Schmid, Maximilian P.; Pötter, Richard; Bombosch, Valentin; Sljivic, Samir; Kirisits, Christian; Dörr, Wolfgang; Goldner, Gregor

    2012-01-01

    Purpose: In general late side-effects after prostate cancer radiotherapy are presented by the use of actuarial incidence rates. The aim of this analysis was to describe additional relevant aspects of late side effects after prostate cancer radiotherapy. Materials and methods: All 178 primary prostate-cancer patients were treated within the Austrian–German multicenter trial by three-dimensional radiotherapy up to a local dose of 70 Gy (low/intermediate-risk) or 74 Gy (high-risk), respectively. Late gastrointestinal/urogenital (GI/GU) side-effects were prospectively assessed by the use of EORTC/RTOG score. Maximum side-effects, actuarial incidence rate and prevalence rates, initial appearance and duration of ⩾grade 2 toxicity were evaluated. Results: Median follow-up was 74 months. Late GI/GU side-effects ⩾grade 2 were detected in 15% (27/178) and 22% (40/178). The corresponding 5-year actuarial incidence rates for GI/GU side-effects were 19% and 23%, whereas the prevalence was 1–2% and 2–7% after 5 years, respectively. Late side effects ⩾grade 2 appeared within 5 years after radiotherapy in all patients with GI side-effects (27/27) and in 85% (34/40) of the patients with GU side-effects, respectively and lasted for less than 3 years in 90% (GI) and 98% (GU). Conclusions: This study demonstrates that the majority of late GI and GU side effects after primary external beam radiotherapy for prostate cancer are transient. Using only actuarial incidence rates for reporting side effects may lead to misinterpretation or overestimation. The combination of incidence and prevalence rates provides a more comprehensive view on the complex issue of late side effects.

  8. Efficacy and safety of pasireotide-LAR for the treatment of refractory bleeding due to gastrointestinal angiodysplasias: results of the ANGIOPAS multicenter phase II noncomparative prospective double-blinded randomized study

    Science.gov (United States)

    Benamouzig, Robert; Benallaoua, Mourad; Saurin, Jean-Christophe; Boubaya, Marouane; Cellier, Christophe; Laugier, René; Vincent, Magalie; Boustière, Christian; Gincul, Rodica; Samaha, Elia; Grandval, Philippe; Aparicio, Thomas; Airinei, Gheorghe; Bejou, Bakhtiar; Bon, Cyriaque; Raynaud, Jean-Jacques; Levy, Vincent; Sautereau, Denis

    2018-01-01

    Background: Gastrointestinal angiodysplasias (GIADs) could be responsible for recurrent bleeding and severe anemia. Somatostatin analogs could reduce transfusion requirements in these patients but no randomized controlled study is available. The main objective of the ANGIOPAS phase II double-blinded randomized, noncomparative study was to assess the effectiveness of pasireotide-LAR in reducing transfusion requirements in patients with refractory GIADs bleeding. Methods: A total of 22 patients with transfusion requirements ⩾6 units of packed red blood cells (pRBCs) during the 6 months prior to inclusion were randomized to receive pasireotide-LAR 60 mg (n = 10) or placebo (n = 12) every 28 days for 6 months. Patients were then followed for an additional 6 months after stopping treatment. Results: The pasireotide-LAR and placebo groups were equivalent for age, sex, comorbidities and transfusion requirement during the reference period (median 13 and 9.5 pRBCs). A 50 and 83% success rate (success defined as a decrease of at least 30% of transfused pRBCs) was observed in the pasireotide-LAR arm in the Intent to Treat (ITT) and per protocol (PP) analysis respectively. The need for transfusion during the intervention period was 3 pRBC units in the pasireotide-LAR group (range 0–26) and 11.5 pRBC units in the placebo group (range 0–23). Overall, three cases with glycemic control impairment were observed in the pasireotide-LAR group including one de novo diabetes. Conclusion: This double-blinded noncomparative randomized phase II study suggests, for the first time, the effectiveness of pasireotide-LAR 60 mg every 28 days to decrease the transfusion requirement in patients with recurrent bleeding due to GIADs. PMID:29479375

  9. Hypofractionated image guided radiation therapy followed by prostate seed implant boost for men with newly diagnosed intermediate and high risk adenocarcinoma of the prostate: Preliminary results of a phase 2 prospective study.

    Science.gov (United States)

    Gresswell, Steven; Wegner, Rodney E; Werts, Day; Miller, Ralph; Fuhrer, Russell

    2016-01-01

    A phase 2 protocol was designed and implemented to assess the toxicity and efficacy of hypofractionated image guided intensity modulated radiation therapy (IG-IMRT) combined with low-dose rate 103 Pd prostate seed implant for treatment of localized intermediate- and high-risk adenocarcinoma of the prostate. This is a report of an interim analysis on 24 patients enrolled on an institutional review board-approved phase 2 single-institution study of patients with intermediate- and high-risk adenocarcinoma of the prostate. The median pretreatment prostate-specific antigen level was 8.15 ng/mL. The median Gleason score was 4 + 3 = 7 (range, 3 + 4 = 7 - 4 + 4 = 8), and the median T stage was T2a. Of the 24 patients, 4 (17%) were high-risk patients as defined by the National Comprehensive Cancer Network criteria, version 2016. The treatment consisted of 2465 cGy in 493 cGy/fraction of IG-IMRT to the prostate and seminal vesicles. This was followed by a 103 Pd transperineal prostate implant boost (prescribed dose to 90% of the prostate volume of 100 Gy) using intraoperative planning. Five patients received neoadjuvant, concurrent, and adjuvant androgen deprivation therapy. The median follow-up was 18 months (range, 1-42 months). The median nadir prostate-specific antigen was 0.5 ng/mL and time to nadir was 16 months. There was 1 biochemical failure associated with distant metastatic disease without local failure. Toxicity (acute or late) higher than grade 3 was not observed. There was a single instance of late grade 3 genitourinary toxicity secondary to hematuria 2 years and 7 months after radiation treatment. There were no other grade 3 gastrointestinal or genitourinary toxicities. Early results on the toxicity and efficacy of the combination of hypofractionated IG-IMRT and low-dose-rate brachytherapy boost are favorable. Longer follow-up is needed to confirm safety and effectiveness.

  10. Moon Phases

    Science.gov (United States)

    Riddle, Bob

    2010-01-01

    When teaching Moon phases, the focus seems to be on the sequence of Moon phases and, in some grade levels, how Moon phases occur. Either focus can sometimes be a challenge, especially without the use of models and observations of the Moon. In this month's column, the author describes some of the lessons that he uses to teach the phases of the Moon…

  11. Google Calendar Enhances Prospective Memory in Alzheimer's Disease: A Case Report.

    Science.gov (United States)

    El Haj, Mohamad; Gallouj, Karim; Antoine, Pascal

    2017-01-01

    We investigated whether an external memory aid (i.e., Google Calendar) would alleviate prospective memory compromise in a patient with mild Alzheimer's disease. The patient was asked in the baseline phase to perform three prospective targeted events (e.g., attending her weekly bridge game at the community club) and three prospective control events (e.g., buying her weekly magazine). The same six prospective events were assessed in the intervention phase but the targeted-events were cued by Google Calendar while the control-events were not. Results showed less omission of the targeted events in the training phase than in the baseline phase, suggesting a positive effect of Google Calendar. This case report offers a unique view into how smartphone calendars may alleviate prospective memory compromise in patients with mild Alzheimer's disease.

  12. Phase Field

    Science.gov (United States)

    Koyama, Toshiyuki

    The term phase field has recently become known across many fields of materials science. The meaning of phase field is the spatial and temporal order parameter field defined in a continuum-diffused interface model. By using the phase field order parameters, many types of complex microstructure changes observed in materials science are described effectively. This methodology has been referred to as the phase field method, phase field simulation, phase field modeling, phase field approach, etc. In this chapter, the basic concept and theoretical background for the phase field approach is explained in Sects. 21.1 and 21.2. The overview of recent applications of the phase field method is demonstrated in Sects. 21.3 to 21.6.

  13. Mindfulness Training for Health Profession Students-The Effect of Mindfulness Training on Psychological Well-Being, Learning and Clinical Performance of Health Professional Students: A Systematic Review of Randomized and Non-randomized Controlled Trials.

    Science.gov (United States)

    McConville, Janet; McAleer, Rachael; Hahne, Andrew

    High levels of stress have been identified in medical students and increasingly in other health profession student population groups. As stress can affect psychological well-being and interfere with learning and clinical performance, there is a clear argument for universities to include health professional student well-being as an outcome in core curriculum. Mindfulness training is a potential construct to manage stress and enhance academic success. The aims of this systematic review were to assess the effectiveness of mindfulness training in medical and other health professional student population groups and to compare the effectiveness of the different mindfulness-based programs. A literature search was completed using The Cochrane library, Medline, Cinahl, Embase, Psychinfo, and ERIC (proquest) electronic databases from inception to June 2016. Randomized and non-randomized controlled trials were included. Of the potential 5355 articles, 19 met the inclusion criteria. Studies focused on medical (n = 10), nursing (n = 4), social work (n = 1), psychology (n = 1), and medical plus other health (n = 3) students. Interventions were based on mindfulness. The 19 studies included 1815 participants. Meta-analysis was performed evaluating the effect of mindfulness training on mindfulness, anxiety, depression, stress, mood, self-efficacy, and empathy. The effect of mindfulness on academic performance was discussed. Mindfulness-based interventions decrease stress, anxiety, and depression and improve mindfulness, mood, self-efficacy, and empathy in health profession students. Due to the range of presentation options, mindfulness training can be relatively easily adapted and integrated into health professional training programs. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. Colchicine in the treatment of the inflammatory phase of Graves' ophthalmopathy: a prospective and randomized trial with prednisone Colchicina no tratamento da fase inflamatória da oftalmopatia de Graves: um estudo prospectivo e randomizado com prednisona

    Directory of Open Access Journals (Sweden)

    Francisco José da Cunha Stamato

    2006-12-01

    Full Text Available PURPOSE: To investigate if colchicine is valuable in the treatment of Graves' ophthalmopathy (GO, we compared its effect with prednisone in 22 patients during the inflammatory phase of GO. METHODS: All patients, similar in age, sex and smoking habits, were euthyroid for at least 3 months and randomly divided into two groups, one treated with colchicine (1.5 mg/day and the other treated with prednisone (0.75 mg/kg/day. They were monitored with ophthalmologic assessment (clinical activity score-CAS and magnetic resonance imaging, using a signal intensity ratio (SIR of the recti muscles in comparison to the cerebral substantia alba. RESULTS: Amelioration of CAS was seen in 68% of the orbits in both groups. SIR also had a significant reduction after treatment: the initial median of 1.14 in G1 and 1.27 in G2, evolved, after treatment, to 1.07 in G1 and 0.69 in G2. The variation between both groups after treatment was not significant (p=0.22. None of the patients treated with colchicine had side effects; on the other hand, side effects in G2 were weight gain, edema, gastric complaints, hirsutism, weakness, depression, and alterations in blood pressure. CONCLUSION: Colchicine had a beneficial effect on the inflammatory phase of GO without the side effects of prednisone.OBJETIVO: Investigar se a colchicina é eficaz no tratamento da oftalmopatia de Graves, nós comparamos o seu efeito com a prednisona em 22 pacientes tratados na fase inflamatória da doença. MÉTODOS: Todos os pacientes, similares quanto à idade, sexo e hábitos de tabagismo, estavam em eutiroidismo por pelo menos três meses e foram randomizados em dois grupos. O grupo 1 (G1 recebeu colchicina (1,5 mg/dia e o grupo 2 (G2 foi tratado com prednisona (0,75 mg/kg/dia. Os pacientes foram acompanhados com avaliação oftalmológica (escore de atividade clínica - CAS e de imagem por meio da ressonância magnética, usando a relação da intensidade de sinal (SIR dos músculos reto em

  15. Inefficacy of Kinesio-Taping(®) on early postoperative pain after ACL reconstruction: Prospective comparative study.

    Science.gov (United States)

    Laborie, M; Klouche, S; Herman, S; Gerometta, A; Lefevre, N; Bohu, Y

    2015-12-01

    Kinesio-Taping(®) (K-Tape) is used in sports traumatology with the aim of reducing pain and improving blood and lymph circulation. The main objective of the present study was to assess the efficacy of K-Tape on early postoperative pain after anterior cruciate ligament (ACL) reconstruction. The study hypothesis was that K-Tape significantly decreases pain. A prospective non-randomized comparative study was conducted in 2013-2014 and included all patients who underwent primary ACL reconstruction by hamstring graft. Analgesia was standardized. Two groups, "K-Tape" and "controls", were formed according to the days on which the study physiotherapist was present. The K-Tape compression/decompression assembly was applied immediately postoperatively and maintained for 3days. Patients filled out online questionnaires. The main assessment criterion was mean postoperative pain (D0-D3) on a 0-to-10 scale. Secondary criteria were analgesia intake on the three WHO levels, awakening during the night of D0 due to pain, signs of postoperative discomfort, and patient satisfaction. Sixty patients (30 per group) were included, 57 of whom could be assessed: 28 K-Tape, 29 controls; 44 male, 13 female; mean age, 30.9±8.9 years. At inclusion, the two groups were comparable. There was no significant difference in mean (D0-D3) knee pain intensity: 3.8±2.2 for K-Tape, and 3.9±2 for controls (P=0.93). Analysis of variance (ANOVA) found no significant intergroup difference in evolution of pain (P=0.34). There were no other significant differences on the other assessment criteria. K-Tape showed no efficacy on early postoperative pain following ACL reconstruction. III; prospective non-randomized comparative study. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  16. Final analysis of the prospective WSG-AGO EC-Doc versus FEC phase III trial in intermediate-risk (pN1) early breast cancer: efficacy and predictive value of Ki67 expression.

    Science.gov (United States)

    Nitz, U; Gluz, O; Huober, J; Kreipe, H H; Kates, R E; Hartmann, A; Erber, R; Moustafa, Z; Scholz, M; Lisboa, B; Mohrmann, S; Möbus, V; Augustin, D; Hoffmann, G; Weiss, E; Böhmer, S; Kreienberg, R; Du Bois, A; Sattler, D; Thomssen, C; Kiechle, M; Jänicke, F; Wallwiener, D; Harbeck, N; Kuhn, W

    2014-08-01

    Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. WSG-AGO epiribicine and cyclophosphamide (EC)-Doc is a large trial evaluating modern taxane-based chemotherapy in patients with 1-3 positive lymph nodes (LNs) only. A total of 2011 BC patients (18-65 years, pN1) were entered into a randomized phase III trial comparing 4 × E90C600 q3w followed by 4 × docetaxel 100 q3w (n = 1008) with the current standard: 6 × F500E100C500 q3w (n = 828) or C600M40F600 d1, 8× q4w (n = 175). Primary end point was event-free survival (EFS); secondary end points were overall survival (OS), toxicity, translational research, and quality of life. Central tumor bank samples were evaluable in a representative collective (n = 772; 40%). Ki-67 was assessed centrally in hormone receptor-positive disease as a surrogate marker for the distinction of luminal A/B-like tumors. Baseline characteristics were well balanced between study arms in both main study and central tumor bank subset. At 59-month median follow-up, superior efficacy of EC-Doc [versus FEC (a combination of 5-fluorouracil, epirubicin, and cyclophosphamide)] was seen in EFS and OS: 5-year EFS: 89.8% versus 87.3% (P = 0.038); 5-year OS: 94.5% versus 92.8% (P = 0.034); both tests one-tailed. EC-Doc caused more toxicity. In hormone receptor-positive (HR)+ disease, only high-Ki-67 tumors (≥ 20%) derived significant benefit from taxane-based therapy: hazard ratio = 0.39 (95% CI 0.18-0.82) for EC-Doc versus FEC (test for interaction; P = 0.01). EC-Doc significantly improved EFS and OS versus FEC in intermediate-risk BC (1-3 LNs) within all subgroups as defined by local pathology. In HR+ disease, patients with luminal A-like tumors may be potentially over-treated by taxane-based chemotherapy. ClinicalTrials.gov, NCT02115204. © The Author 2014. Published by Oxford University Press on behalf of the European Society for

  17. Perceiving prospects properly

    Czech Academy of Sciences Publication Activity Database

    Steiner, Jakub; Stewart, C.

    2016-01-01

    Roč. 106, č. 7 (2016), s. 1601-1631 ISSN 0002-8282 R&D Projects: GA ČR(CZ) GA13-34759S; GA ČR(CZ) GA16-00703S Institutional support: PRVOUK-P23 Keywords : evolution * perception bias * prospect theory Subject RIV: AH - Economics Impact factor: 4.026, year: 2016

  18. Nuclear power prospects

    International Nuclear Information System (INIS)

    Staebler, K.

    1994-01-01

    The technical, economic and political prospects of nuclear power are described with regard to ecological aspects. The consensus talks, which failed in spite of the fact that they were stripped of emotional elements and in spite of major concessions on the part of the power industry, are discussed with a view to the political and social conditions. (orig.) [de

  19. Prospects after Major Trauma

    NARCIS (Netherlands)

    Holtslag, H.R.

    2007-01-01

    Introduction. After patients survived major trauma, their prospects, in terms of the consequences for functioning, are uncertain, which may impact severely on patient, family and society. The studies in this thesis describes the long-term outcomes of severe injured patients after major trauma. In

  20. Study of effects of climate change in the Great South East. Stage 1. PACA report - Part I: Context and study summary, Part II: Climate simulations, Part III: Impact sector sheets, General report. Prospective study of effects of climate change in the Great South East (phase 2) - Mission of study of inter-regional and European collaborations

    International Nuclear Information System (INIS)

    Kornmann, Francois; Guiran, Ghislaine; Sadoux, Emmanuel; Weill, Frederic; Benkhelifa, Fouzi

    2008-01-01

    After a presentation of study objectives and scope, a first report outlines the actuality of climate change, describes predicted climate changes for the PACA region in terms of warming and decrease of precipitations. Regional social-economic challenges and sector impacts are also briefly described. The second report presents the adopted climate simulation parameters, and discusses results obtained in terms of temperature and of precipitations by 2030, 2050 and 2080 for the whole Great South East region. The third part proposes sector sheets which contain discussions of effects of climate change on the water resource, on biodiversity, on forest, on agriculture, on human health, on tourism, on energy, on building and transports, on natural risks. The next document is based on the previous ones. It discusses and comments the outcome of the first phase, the present situation of the region in terms of territorial dynamics and effects of climate change, and indicators of climate change. It also draws lessons from the prospective study which resulted in three scenarios for which a strategic assessment is proposed

  1. Clinical impact of NK-cell reconstitution after reduced intensity conditioned unrelated cord blood transplantation in patients with acute myeloid leukemia: analysis of a prospective phase II multicenter trial on behalf of the Société Française de Greffe de Moelle Osseuse et Thérapie Cellulaire and Eurocord.

    Science.gov (United States)

    Nguyen, S; Achour, A; Souchet, L; Vigouroux, S; Chevallier, P; Furst, S; Sirvent, A; Bay, J-O; Socié, G; Ceballos, P; Huynh, A; Cornillon, J; Francois, S; Legrand, F; Yakoub-Agha, I; Michel, G; Maillard, N; Margueritte, G; Maury, S; Uzunov, M; Bulabois, C-E; Michallet, M; Clement, L; Dauriac, C; Bilger, K; Lejeune, J; Béziat, V; Rocha, V; Rio, B; Chevret, S; Vieillard, V

    2017-10-01

    Unrelated cord blood transplantation (UCBT) after a reduced intensity conditioning regimen (RIC) has extended the use of UCB in elderly patients and those with co-morbidities without an HLA-identical donor, although post-transplant relapse remains a concern in high-risk acute myeloid leukemia (AML) patients. HLA incompatibilities between donor and recipient might enhance the alloreactivity of natural killer (NK) cells after allogeneic hematopoietic stem-cell transplantation (HSCT). We studied the reconstitution of NK cells and KIR-L mismatch in 54 patients who underwent a RIC-UCBT for AML in CR in a prospective phase II clinical trial. After RIC-UCBT, NK cells displayed phenotypic features of both activation and immaturity. Restoration of their polyfunctional capacities depended on the timing of their acquisition of phenotypic markers of maturity. The incidence of treatment-related mortality (TRM) was correlated with low CD16 expression (P=0.043) and high HLA-DR expression (P=0.0008), whereas overall survival was associated with increased frequency of NK-cell degranulation (P=0.001). These features reflect a general impairment of the NK licensing process in HLA-mismatched HSCT and may aid the development of future strategies for selecting optimal UCB units and enhancing immune recovery.

  2. Effectiveness of the “What’s Up!” Intervention to Reduce Stigma and Psychometric Properties of the Youth Program Questionnaire (YPQ: Results from a Cluster Non-randomized Controlled Trial Conducted in Catalan High Schools

    Directory of Open Access Journals (Sweden)

    Laura Andrés-Rodríguez

    2017-09-01

    Full Text Available Mental disorders are highly prevalent in the general population, and people who experience them are frequently stigmatized. Stigma has a very negative impact on social, academic/professional, and personal life. Considering the high rates of mental disorders among children and adolescents (13.4% and how critical this age is in the formation of nuclear beliefs, many campaigns to combat stigma have been developed in the last decade, with mixed results. The OBERTAMENT initiative has produced various anti-stigma campaigns in Catalonia (Spain. In the present study, the main objective was to report on the effectiveness of the OBERTAMENT “What’s up!” intervention, a curricular intervention including education and social contact conducted by the teachers in the classroom with teenagers aged between 14 and 18. Prior to this, we examined the psychometric properties of the Youth Program Questionnaire (YPQ, our main outcome measure, in terms of dimensionality, reliability, and validity. A cluster non-randomized controlled trial was conducted to assess this intervention, which was tested in nine high schools situated in the Barcelona region. A convenience sample of 261 students formed the intervention group and 132 the control group (52% women, mean age = 14, SD = 0.47. The assignment to study conditions was conducted by Departament d’Ensenyament (Department of Education, Generalitat de Catalunya (Catalan Government. Participants were evaluated at baseline, post-intervention, and 9-month follow-up. The main outcome measure of this study was the YPQ. The Reported and Intended Behavior Scale (RIBS was used as secondary outcome measure. The statistical analysis indicated that the YPQ possesses a two-factor structure (stereotypical attitudes and intended behavior and sound psychometric properties. The multilevel mixed-effects models revealed statistically significant interactions for both study measures and post hoc intragroup analyses revealed a

  3. Estudos dos padrões de não aleatoriedade dos gráficos de controle de Shewhart: um enfoque probabilístico Studies on non-random patterns in Shewhart control charts

    Directory of Open Access Journals (Sweden)

    Quintiliano Siqueira Schroden Nomelini

    2009-09-01

    Full Text Available Além de investimento em novas tecnologias e modernização do parque industrial, a competitividade dos produtos brasileiros está ligada ao aumento de produtividade. O Controle Estatístico de Processo (CEP, junto com os gráficos de controle, inseriu-se neste contexto no que diz respeito ao controle das características significativas do produto e do processo, em tempo real, garantindo níveis de qualidade, a um custo exigido pelo mercado. Um procedimento importante é a interpretação dos gráficos de controle. Um estudo foi feito para ilustrar e discutir padrões de não aleatoriedade, que auxiliam na interpretação de tais gráficos. Alguns padrões de não aleatoriedade foram ilustrados e, por meio de cálculo de probabilidade, mostrou-se quais deles rejeitaram a hipótese de controle estatístico, a um nível de significância pré-especificado. Concluiu-se que os padrões mencionados na literatura não eram tão informativos. No que diz respeito ao nível de significância, observou-se então que em alguns padrões a um certo nível de significância retornaram resultados diferentes dos mencionados na literatura.In the last two decades, the Brazilian consuming market was modified by the insertion of products of better quality and minor cost. Statistical Process Control (SPC and control charts look after significant characteristics products and processes, in real time, guaranteeing quality levels, in a cost demanded by the market. In that context, an important procedure is the interpretation of the control charts; this is made through non-random patters. A study was made illustrating and arguing such standards. Standards had been illustrated and one revealed which of them, rejected the nullity hypothesis, under a determined significance. One concluded that the standards mentioned in literature are not so informative and can be improved.

  4. The uranium market prospects

    International Nuclear Information System (INIS)

    Lloyd, R.

    1981-01-01

    A historical analysis of the uranium market points out the cyclical nature of the market and suggests that the spot price, exploration levels, and mill capacity utilization rate are dependent on economic factors. An examination of the current uranium market suggests that the effects of the forecasted surplus supply, the diminishing returns in exploration and the long lead times and high costs of development may mean that future production levels are uncertain. The general prospects for the uranium industry are also uncertain because of barriers to trade, environmental regulations and public opinion. The paper concludes that by the use of long term contracts, appropriate inventory policy and greater discussion between producers and consumers the prospects for the uranium market can be made more certain and further imbalances in demand and supply can be avoided. (author)

  5. Radimetric autotransported prospecting survey

    International Nuclear Information System (INIS)

    Coco, A.L.; Azamor, L.A.; Agost, E.J.

    1977-10-01

    A procedure of prospection of minerals (''carborne''). It is characterized to be rapid and low costly if a sufficiently dense highway network is available or if transit with a vehicle across the fields is possible. Instruments, methods and results that may be obtained are given. The detector, a scintillation counter, is mounted on the top of an appropiate car registering continuously the measured values. Subsequently data are put on cartography, obtaining thus the values of iso-radiactivity which determine the values of ''background'' and the favorable zones for pursuing prospection work by other methods. The application of the method to the zone of the Chihuidos, province of Neuquen, is described in details and the obtained conclusions are given. (author) [es

  6. Prospecting for lunar resources

    Science.gov (United States)

    Taylor, G.; Martel, L.

    Large space settlements on the Moon (thousands of people) will require use of indigenous resources to build and maintain the infrastructure and generate products for export. Prospecting for these resources is a crucial step in human migration to space and needs to begin before settlement and the establishment of industrial complexes. We are devising a multi-faceted approach to prospect for resources. A central part of this work is developing the methodology for prospecting the Moon and other planetary bodies. This involves a number of investigations: (1) It is essential to analyze the economics of planetary ore deposits. Ore deposits are planetary materials that we can mine, process, and deliver to customers at a profit. The planetary context tosses in some interesting twists to this definition. (2) We are also making a comprehensive theoretical assessment of potential lunar ore deposits. Our understanding of the compositions, geological histories, and geological processes on the Moon will lead to significant differences in how we assess wh a t types of ores could be present. For example, the bone-dry nature of the Moon (except at the poles) eliminates all ore deposits associated with hydrothermal fluids. (3) We intend to search for resources using existing data for the Moon. Thus, prospecting can begin immediately. We have a wealth of remote sensing data for the Moon. We also have a good sampling of the Moon by the Apollo and Luna missions, and from lunar meteorites. We can target specific types of deposits already identified (e.g. lunar pyroclastic deposits) and look for other geological settings that might have produced ores and other materials of economic value. Another approach we will take is to examine all data available to look for anomalies. Examples are unusual spectral properties, large disagreements between independent techniques that measure the same property, unusual elemental ratios, or simply exceptional properties such as elemental abundances much

  7. Characterizing and validating the PROSPECT segmented scintillator detector design

    Science.gov (United States)

    Norcini, Danielle; Prospect Collaboration

    2016-03-01

    The PROSPECT experiment will use two segmented liquid scintillator detectors positioned 7-20m from the High Flux Isotope Reactor (HFIR) core to perform a search for eV-scale sterile neutrinos and measure the antineutrino spectrum of uranium-235. A multi-year R&D program focused on background studies at the HFIR reactor, lithium-loaded liquid scintillator development, and characterization of multiple prototype detectors has culminated in the design of a segmented, 3-ton liquid scintillator detector for PROSPECT Phase I. This detector design is being validated with a 50 liter, 2-segment prototype detector, PROSPECT-50. We will report results of on-going performance and calibration studies and discuss implications for the PROSPECT physics program.

  8. Prospects for Tokamak Fusion Reactors

    International Nuclear Information System (INIS)

    Sheffield, J.; Galambos, J.

    1995-01-01

    This paper first reviews briefly the status and plans for research in magnetic fusion energy and discusses the prospects for the tokamak magnetic configuration to be the basis for a fusion power plant. Good progress has been made in achieving fusion reactor-level, deuterium-tritium (D-T) plasmas with the production of significant fusion power in the Joint European Torus (up to 2 MW) and the Tokamak Fusion Test Reactor (up to 10 MW) tokamaks. Advances on the technologies of heating, fueling, diagnostics, and materials supported these achievements. The successes have led to the initiation of the design phases of two tokamaks, the International Thermonuclear Experimental Reactor (ITER) and the US Toroidal Physics Experiment (TPX). ITER will demonstrate the controlled ignition and extended bum of D-T plasmas with steady state as an ultimate goal. ITER will further demonstrate technologies essential to a power plant in an integrated system and perform integrated testing of the high heat flux and nuclear components required to use fusion energy for practical purposes. TPX will complement ITER by testing advanced modes of steady-state plasma operation that, coupled with the developments in ITER, will lead to an optimized demonstration power plant

  9. Self-propelled prospection methodology: first results obtained in the northeast basin (Uruguay)

    International Nuclear Information System (INIS)

    Goso, H; Spoturno, J; Peciozzi, F.

    2008-01-01

    This report refers about uranium prospection methodology in Uruguay and its first results obtained in the northeast basin.The preliminary radiometric researching is carried out four works phases: material preparation, radiometric, statistics analysis, anomalies revision

  10. Comparison of escitalopram and citalopram in outpatients with severe major depressive disorder: a prospective, naturalistic, 8-week study.

    Science.gov (United States)

    Lançon, Christophe; Sapin, Christophe; Note, Ivan; Farisse, Jean

    2006-01-01

    Objective. Escitalopram is a new selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD). The objective of this study is to examine its efficacy in the treatment of severe MDD compared with that of citalopram in daily practice. Method. A prospective, naturalistic, 8-week study was conducted involving 127 patients fulfilling DSM-IV criteria for severe MDD and having a baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 30. A full non-parsimonious logistic model, called the propensity score, was first defined to reduce bias associated with non-randomization. The primary efficacy analysis was the mean change from baseline to week 8 in MADRS score between the escitalopram and citalopram groups, after stratification on the propensity score. Other efficacy measurements consisted of the Clinical Global Impression of Severity and Improvement scales (CGI-S and CGI-I, respectively), response (defined as a reduction of at least 50% on MADRS from baseline to week 8) and remission rates (defined as MADRS ≤ 12 at week 8), after adjustment on propensity score for escitalopram use. Results. A total of 67 escitalopram-treated patients and 60 citalopram-treated patients were enrolled in this study. Escitalopram reduced mean MADRS total score at week 8 compared with citalopram (-23.5 vs. -17.5; Pbiases due to non-randomization, this study indicates better efficacy and tolerability of escitalopram versus citalopram in severe MDD outpatients.

  11. Phase transitions

    CERN Document Server

    Sole, Ricard V; Solé, Ricard V; Solé, Ricard V; Sol, Ricard V; Solé, Ricard V

    2011-01-01

    Phase transitions--changes between different states of organization in a complex system--have long helped to explain physics concepts, such as why water freezes into a solid or boils to become a gas. How might phase transitions shed light on important problems in biological and ecological complex systems? Exploring the origins and implications of sudden changes in nature and society, Phase Transitions examines different dynamical behaviors in a broad range of complex systems. Using a compelling set of examples, from gene networks and ant colonies to human language and the degradation of diverse ecosystems, the book illustrates the power of simple models to reveal how phase transitions occur. Introductory chapters provide the critical concepts and the simplest mathematical techniques required to study phase transitions. In a series of example-driven chapters, Ricard Solé shows how such concepts and techniques can be applied to the analysis and prediction of complex system behavior, including the origins of ...

  12. Planning for Planetary Science Mission Including Resource Prospecting, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Advances in computer-aided mission planning can enhance mission operations and science return for surface missions to Mars, the Moon, and beyond. While the...

  13. Robotic Tool for Asteroid Resource Prospecting and Characterization, Phase I

    Data.gov (United States)

    National Aeronautics and Space Administration — Optical fibers are inherently tolerant of cosmic radiation and a wide temperature range, immune to electromagnetic noise and thus solar flares, etc. Embedded fiber...

  14. Remote sensing prospection

    Directory of Open Access Journals (Sweden)

    Jeremy Bennett

    2012-12-01

    Full Text Available During the Capo Mannu Project 2011 fieldwork season, three separate sites were selected for remote sensing prospection: Su Pallosu (Beachfront and Upper Platform, Sa Rocca Tunda (Beachfront and Serra Is Araus. These areas have in common the presence of buried structures and/or ceramic deposits, and represent the favourite candidates for future excavations in the area. The level of success attained across the sites was not very high, which awkward topography and/or unusual geological circumstances hindering the usually reliant magnetometer survey method.

  15. Predictors of clinical recovery from vestibular neuritis: a prospective study.

    Science.gov (United States)

    Cousins, Sian; Kaski, Diego; Cutfield, Nicholas; Arshad, Qadeer; Ahmad, Hena; Gresty, Michael A; Seemungal, Barry M; Golding, John; Bronstein, Adolfo M

    2017-05-01

    We sought to identify predictors of symptomatic recovery in vestibular neuritis. Forty VN patients were prospectively studied in the acute phase (median = 2 days) and 32 in the recovery phase (median = 10 weeks) with vestibulo-ocular reflex, vestibular-perceptual, and visual dependence tests and psychological questionnaires. Clinical outcome was Dizziness Handicap Inventory score at recovery phase. Acute visual dependency and autonomic arousal predicted outcome. Worse recovery was associated with a combination of increased visual dependence, autonomic arousal, anxiety/depression, and fear of bodily sensations, but not with vestibular variables. Findings highlight the importance of early identification of abnormal visual dependency and concurrent anxiety.

  16. Nuclear energy prospects

    International Nuclear Information System (INIS)

    Jones, P.M.S.

    1978-01-01

    This paper by the Head of the Economics and Programmes Branch of the United Kingdom Atomic Energy Authority discusses the UK and world prospects for nuclear energy and concludes that there is no technical obstacle to its becoming the 'workhorse' both for the UK and the world. If the fast reactor programme is continued there is no reason why this situation should not persist through the greater part of the next century, backed up where appropriate by coal, gas and other energy sources. There is no energy barrier to continued growth and to progressive improvement of living standards, and given the political will and international co-operation the world could become an even better place in which to live. The paper includes an appraisal of the well publicised opposition that has arisen in the world questioning the wisdom of the widespread adoption of nuclear power, and also surveys pronouncements made in its favour. (UK)

  17. Prospects at high energies

    International Nuclear Information System (INIS)

    Quigg, C.

    1988-11-01

    I discuss some possibilities for neutrino experiments in the fixed-target environment of the SPS, Tevatron, and UNK, with their primary proton beams of 0.4, 0.9, and 3.0 TeV. The emphasis is on unfinished business: issues that have been recognized for some time, but not yet resolved. Then I turn to prospects for proton-proton colliders to explore the 1-TeV scale. I review the motivation for new physics in the neighborhood of 1 TeV and mention some discovery possibilities for high-energy, high-luminosity hadron colliders and the implications they would have for neutrino physics. I raise the possibility of the direct study of neutrino interactions in hadron colliders. I close with a report on the status of the SSC project. 38 refs., 17 figs

  18. Prospects for future climate

    International Nuclear Information System (INIS)

    Anon.

    1990-01-01

    The different climates of the past and model simulations of future climates convincingly indicate that the continuing emissions of greenhouse gases will lead to significant global warming and to changes in precipitation and other climatic variables. The projected changes in atmospheric composition and, consequently, in climatic conditions will be unique and more rapid than at any time in the past. The developing understanding of the chemical cycles controlling atmospheric composition and of the processes and behavior controlling the climate system can provide significant guidance about how the future climate will change. This chapter first summarizes the many scientific advances described in the preceding chapters that can help one better understand and describe the climate system and the resulting agricultural and hydrological impacts of these changes in climate. The chapter then draws from this understanding to outline the prospects for future climate

  19. Prospective Ukrainian lunar orbiter mission

    Science.gov (United States)

    Shkuratov, Y.; Litvinenko, L.; Shulga, V.; Yatskiv, Y.; Kislyuk, V.

    Ukraine has launch vehicles that are able to deliver about 300 kg to the lunar orbit. Future Ukrainian lunar program may propose a polar orbiter. This orbiter should fill principal information gaps in our knowledge about the Moon after Clementine and Lunar Prospector missions and the future missions, like Smart-1, Lunar-A, and Selene. We consider that this can be provided by radar studies of the Moon with supporting optical polarimetric observations from lunar polar orbit. These experiments allow one to better understand global structure of the lunar surface in a wide range of scales, from microns to kilometers. We propose three instruments for the prospective lunar orbiter. They are: a synthetic aperture imaging radar (SAR), ground-penetrating radar (GPR), and imaging polarimeter (IP). The main purpose of SAR is to study with high resolution (50 m) the permanently shadowed sites in the lunar polar regions. These sites are cold traps for volatiles, and have a potential of resource utilization. Possible presence of water ice in the regolith in the sites makes them interesting for permanent manned bases on the Moon. Radar imaging and mapping of other interesting regions could be also planned. Multi-frequencies multi-polarization soun d ing of the lunar surface with GPR can provide information about internal structure of the lunar surface from meters to several hundred meters deep. GPR can be used for measuring the megaregolith layer properties, detection of cryptomaria, and studies of internal structure of the largest craters. IP will be a CCD camera with an additional suite of polarizers. Modest spatial resolution (100 m) should provide a total coverage or a large portion of the lunar surface in oblique viewing basically at large phase angles. Polarization degree at large (>90°) phase angles bears information about characteristic size of the regolith particles. Additional radiophysical experiments are considered with the use of the SAR system, e.g., bistatic radar

  20. prospective mathematics and physics teachers

    African Journals Online (AJOL)

    prospective mathematics and physics teachers. Claudio Fazio and Filippo Spagnolo spagnolo@math.unipa.it. We present a study on the conceptions of Italian prospective mathematics and physics teachers with respect to modelling activities. Common ground for both the mathematician and the physicist, these activities are ...

  1. Location-based prospective memory.

    Science.gov (United States)

    O'Rear, Andrea E; Radvansky, Gabriel A

    2018-02-01

    This study explores location-based prospective memory. People often have to remember to do things when in a particular location, such as buying tissues the next time they are in the supermarket. For event cognition theory, location is important for structuring events. However, because event cognition has not been used to examine prospective memory, the question remains of how multiple events will influence prospective memory performance. In our experiments, people delivered messages from store to store in a virtual shopping mall as an ongoing task. The prospective tasks were to do certain activities in certain stores. For Experiment 1, each trial involved one prospective memory task to be done in a single location at one of three delays. The virtual environment and location cues were effective for prospective memory, and performance was unaffected by delay. For Experiment 2, each trial involved two prospective memory tasks, given in either one or two instruction locations, and to be done in either one or two store locations. There was improved performance when people received instructions from two locations and did both tasks in one location relative to other combinations. This demonstrates that location-based event structure influences how well people perform on prospective memory tasks.

  2. Prospective evaluation of prognostic factors uPA/PAI-1 in node-negative breast cancer: phase III NNBC3-Europe trial (AGO, GBG, EORTC-PBG) comparing 6×FEC versus 3×FEC/3×Docetaxel.

    Science.gov (United States)

    Kantelhardt, Eva J; Vetter, Martina; Schmidt, Marcus; Veyret, Corinne; Augustin, Doris; Hanf, Volker; Meisner, Christoph; Paepke, Daniela; Schmitt, Manfred; Sweep, Fred; von Minckwitz, Gunter; Martin, Pierre-Marie; Jaenicke, Fritz; Thomssen, Christoph; Harbeck, Nadia

    2011-04-16

    Today, more than 70% of patients with primary node-negative breast cancer are cured by local therapy alone. Many patients receive overtreatment by adjuvant chemotherapy due to inadequate risk assessment. So far, few clinical trials have prospectively evaluated tumor biology based prognostic factors. Risk assessment by a biological algorithm including invasion factors urokinase-type plasminogen activator (uPA) and its inhibitor plasminogen activator inhibitor type 1 (PAI-1) will assess up to 35-55% of node-negative patients as low-risk and thus avoid chemotherapy. In contrast, a clinical-pathological algorithm will only classify 20-40% of patients as low-risk. High-risk node-negative patients should receive chemotherapy. Anthracycline-based regimens are accepted as a standard, the additional benefit of taxanes remains an open question. The international NNBC3 ("Node Negative Breast Cancer 3-Europe") trial compares biological risk assessment (UP) using invasion factors uPA/PAI-1 with a clinical-pathological algorithm (CP). In this trial, the type of risk assessment (CP or UP) was chosen upfront by each center for its patients. Fresh frozen tissue was obtained to determine uPA/PAI-1 using an enzyme-linked immunosorbent assay (ELISA). Patients assessed as high-risk were stratified by human epidermal growth factor receptor 2 (HER2) status and then randomised to receive anthracycline-containing chemotherapy 5-Fluorouracil (F)/Epirubicin (E)/Cyclophosphymide (C) or an anthracycline-taxane sequence (FE(100)C*6 versus FE(100)C*3 followed by Docetaxel(100)*3). In this trial, 4,149 node-negative patients with operable breast cancer from 153 centers in Germany and France were included since 2002. Measurement of uPA/PAI-1 by ELISA was performed with standardised central quality assurance for 2,497 patients (60%) from 56 "UP"-centers. The NNBC 3-Europe trial showed that inclusion of patients into a clinical phase III trial is feasible based on biological testing of fresh frozen

  3. DECIDER: prospective randomized multicenter phase II trial of low-dose decitabine (DAC) administered alone or in combination with the histone deacetylase inhibitor valproic acid (VPA) and all-trans retinoic acid (ATRA) in patients >60 years with acute myeloid leukemia who are ineligible for induction chemotherapy

    International Nuclear Information System (INIS)

    Grishina, Olga; Schmoor, Claudia; Döhner, Konstanze; Hackanson, Björn; Lubrich, Beate; May, Annette M.; Cieslik, Caroline; Müller, Michael J.; Lübbert, Michael

    2015-01-01

    Acute myeloid leukemia (AML) is predominantly a disease of older patients with a poor long-term survival. Approval of decitabine (DAC) in the European Union (EU) in 2012 for the treatment of patients with AML ≥65 years marks the potential for hypomethylating agents in elderly AML. Nevertheless the situation is dissatisfactory and the quest for novel treatment approaches, including combination epigenetic therapy is actively ongoing. The given randomized trial should be helpful in investigating the question whether combinations of DAC with the histone deacetylase (HDAC) inhibitor valproic acid (VPA) and/or all-trans retinoic acid (ATRA), which in vitro show a very promising synergism, are superior to the DAC monotherapy. The accompanying translational research project will contribute to find surrogate molecular end points for drug efficacy and better tailor epigenetic therapy. An additional aim of the study is to investigate the prognostic value of geriatric assessments for elderly AML patients treated non-intensively. DECIDER is a prospective, randomized, observer blind, parallel group, multicenter, Phase II study with a 2x2 factorial design. The primary endpoint is objective best overall response (complete remission (CR) and partial remission (PR)). The target population is AML patients aged 60 years or older and unfit for standard induction chemotherapy. Patients are randomized to one of the four treatment groups: DAC alone or in combination with VPA or ATRA or with both add-on drugs. One interim safety analysis was planned and carried out with the objective to stop early one or more of the treatment arms in case of an unacceptable death rate. This analysis showed that in all treatment arms the critical stopping rule was not reached. No important safety issues were observed. The Data Monitoring Committee (DMC) recommended continuing the study as planned. The first patient was included in December 2011. A total of 189 out of 200 planned patients were randomized

  4. Phase Vocoder

    Directory of Open Access Journals (Sweden)

    J.L. Flanagan

    2013-08-01

    Full Text Available A vocoder technique is described in which speech signals are represented by their short-time phase and amplitude spectra. A complete transmission system utilizing this approach is simulated on a digital computer. The encoding method leads to an economy in transmission bandwidth and to a means for time compression and expansion of speech signals.

  5. ATLAS Detector Upgrade Prospects

    International Nuclear Information System (INIS)

    Dobre, M

    2017-01-01

    After the successful operation at the centre-of-mass energies of 7 and 8 TeV in 2010-2012, the LHC was ramped up and successfully took data at the centre-of-mass energies of 13 TeV in 2015 and 2016. Meanwhile, plans are actively advancing for a series of upgrades of the accelerator, culminating roughly ten years from now in the high-luminosity LHC (HL-LHC) project, which will deliver of the order of five times the LHC nominal instantaneous luminosity along with luminosity levelling. The ultimate goal is to extend the dataset from about few hundred fb −1 expected for LHC running by the end of 2018 to 3000 fb −1 by around 2035 for ATLAS and CMS. The challenge of coping with the HL-LHC instantaneous and integrated luminosity, along with the associated radiation levels, requires further major changes to the ATLAS detector. The designs are developing rapidly for a new all-silicon tracker, significant upgrades of the calorimeter and muon systems, as well as improved triggers and data acquisition. ATLAS is also examining potential benefits of extensions to larger pseudorapidity, particularly in tracking and muon systems. This report summarizes various improvements to the ATLAS detector required to cope with the anticipated evolution of the LHC luminosity during this decade and the next. A brief overview is also given on physics prospects with a pp centre-of-mass energy of 14 TeV. (paper)

  6. ATLAS Detector Upgrade Prospects

    Science.gov (United States)

    Dobre, M.; ATLAS Collaboration

    2017-01-01

    After the successful operation at the centre-of-mass energies of 7 and 8 TeV in 2010-2012, the LHC was ramped up and successfully took data at the centre-of-mass energies of 13 TeV in 2015 and 2016. Meanwhile, plans are actively advancing for a series of upgrades of the accelerator, culminating roughly ten years from now in the high-luminosity LHC (HL-LHC) project, which will deliver of the order of five times the LHC nominal instantaneous luminosity along with luminosity levelling. The ultimate goal is to extend the dataset from about few hundred fb -1 expected for LHC running by the end of 2018 to 3000 fb -1 by around 2035 for ATLAS and CMS. The challenge of coping with the HL-LHC instantaneous and integrated luminosity, along with the associated radiation levels, requires further major changes to the ATLAS detector. The designs are developing rapidly for a new all-silicon tracker, significant upgrades of the calorimeter and muon systems, as well as improved triggers and data acquisition. ATLAS is also examining potential benefits of extensions to larger pseudorapidity, particularly in tracking and muon systems. This report summarizes various improvements to the ATLAS detector required to cope with the anticipated evolution of the LHC luminosity during this decade and the next. A brief overview is also given on physics prospects with a pp centre-of-mass energy of 14 TeV.

  7. Solid-phase spectrophotometry

    International Nuclear Information System (INIS)

    Brykina, G.D.; Marchenko, D.Yu.; Shpigun, O.A.

    1995-01-01

    Solid-phase spectrophotometry (SPS), which is based on the direct measurement of light absorption of an ion exchanger containing a substance of interest, was reviewed. Since 1976, it has been known that aborbance of an ion exchanger is directly proportional to the concentration of a particular ion in solution. A similar dependence can also be followed for other sorbents, as well as for foams, membranes, films, etc., which do not exhibit ion exchange properties. One can use absorption, diffuse reflection, and luminescence spectra parameters as an analytical signal. Thus, SPS of ion exchangers is among the analytical techniques that combine the sorption concentration and surface determination of the substance of interest. This review summarizes the advancements in SPS over the last six years and demonstrates the prospects for its development. Special attention is paid to experimental methods for measuring solid-phase absorption and to the basic procedures of sample preparation, including new ones. These two facets are of great importance for obtaining precise results and extending the capabilities of SPS

  8. Uranium prospecting; La prospection de l'uranium

    Energy Technology Data Exchange (ETDEWEB)

    Roubault, M. [Commissariat a l' Energie Atomique, Saclay (France). Centre d' Etudes Nucleaires

    1955-07-01

    This report is an instruction book for uranium prospecting. It appeals to private prospecting. As prospecting is now a scientific and technical research, it cannot be done without preliminary studies. First of all, general prospecting methods are given with a recall of fundamental geologic data and some general principles which are common with all type of prospecting. The peculiarities of uranium prospecting are also presented and in particular the radioactivity property of uranium as well as the special aspect of uranium ores and the aspect of neighbouring ores. In a third part, a description of the different uranium ores is given and separated in two different categories: primary and secondary ores, according to the place of transformation, deep or near the crust surface respectively. In the first category, the primary ores include pitchblende, thorianite and rare uranium oxides as euxenite and fergusonite for example. In the second category, the secondary ores contain autunite and chalcolite for example. An exhaustive presentation of the geiger-Mueller counter is given with the presentation of its different components, its functioning and utilization and its maintenance. The radioactivity interpretation method is showed as well as the elaboration of a topographic map of the measured radioactivity. A brief presentation of other detection methods than geiger-Mueller counters is given: the measurement of fluorescence and a chemical test using the fluorescence properties of uranium salts. Finally, the main characteristics of uranium deposits are discussed. (M.P.)

  9. Fuel cells: Problems and prospects

    OpenAIRE

    Shukla, AK; Ramesh, KV; Kannan, AM

    1986-01-01

    n recent years, fuel cell technology has advanced significantly. Field trials on certain types of fuel cells have shown promise for electrical use. This article reviews the electrochemistry, problems and prospects of fuel cell systems.

  10. Prospect of ultralight airplanes development

    Directory of Open Access Journals (Sweden)

    Adam KONICZEK

    2015-09-01

    Full Text Available The article presents characteristic of ultralight airplanes, rules and current interest of them. The purpose is to determine prospect of ultralight airplanes development on the basis of Civil Aviation Authority statistics analysis and trend of aviation market.

  11. Amino-acid PET versus MRI guided re-irradiation in patients with recurrent glioblastoma multiforme (GLIAA) - protocol of a randomized phase II trial (NOA 10/ARO 2013-1).

    Science.gov (United States)

    Oehlke, Oliver; Mix, Michael; Graf, Erika; Schimek-Jasch, Tanja; Nestle, Ursula; Götz, Irina; Schneider-Fuchs, Sabine; Weyerbrock, Astrid; Mader, Irina; Baumert, Brigitta G; Short, Susan C; Meyer, Philipp T; Weber, Wolfgang A; Grosu, Anca-Ligia

    2016-10-05

    The higher specificity of amino-acid positron emission tomography (AA-PET) in the diagnosis of gliomas, as well as in the differentiation between recurrence and treatment-related alterations, in comparison to contrast enhancement in T1-weighted MRI was demonstrated in many studies and is the rationale for their implementation into radiation oncology treatment planning. Several clinical trials have demonstrated the significant differences between AA-PET and standard MRI concerning the definition of the gross tumor volume (GTV). A small single-center non-randomized prospective study in patients with recurrent high grade gliomas treated with stereotactic fractionated radiotherapy (SFRT) showed a significant improvement in survival when AA-PET was integrated in target volume delineation, in comparison to patients treated based on CT/MRI alone. This protocol describes a prospective, open label, randomized, multi-center phase II trial designed to test if radiotherapy target volume delineation based on FET-PET leads to improvement in progression free survival (PFS) in patients with recurrent glioblastoma (GBM) treated with re-irradiation, compared to target volume delineation based on T1Gd-MRI. The target sample size is 200 randomized patients with a 1:1 allocation ratio to both arms. The primary endpoint (PFS) is determined by serial MRI scans, supplemented by AA-PET-scans and/or biopsy/surgery if suspicious of progression. Secondary endpoints include overall survival (OS), locally controlled survival (time to local progression or death), volumetric assessment of GTV delineated by either method, topography of progression in relation to MRI- or PET-derived target volumes, rate of long term survivors (>1 year), localization of necrosis after re-irradiation, quality of life (QoL) assessed by the EORTC QLQ-C15 PAL questionnaire, evaluation of safety of FET-application in AA-PET imaging and toxicity of re-irradiation. This is a protocol of a randomized phase II trial

  12. Amino-acid PET versus MRI guided re-irradiation in patients with recurrent glioblastoma multiforme (GLIAA) – protocol of a randomized phase II trial (NOA 10/ARO 2013-1)

    International Nuclear Information System (INIS)

    Oehlke, Oliver; Mix, Michael; Graf, Erika; Schimek-Jasch, Tanja; Nestle, Ursula; Götz, Irina; Schneider-Fuchs, Sabine; Weyerbrock, Astrid; Mader, Irina; Baumert, Brigitta G.; Short, Susan C.; Meyer, Philipp T.; Weber, Wolfgang A.; Grosu, Anca-Ligia

    2016-01-01

    The higher specificity of amino-acid positron emission tomography (AA-PET) in the diagnosis of gliomas, as well as in the differentiation between recurrence and treatment-related alterations, in comparison to contrast enhancement in T1-weighted MRI was demonstrated in many studies and is the rationale for their implementation into radiation oncology treatment planning. Several clinical trials have demonstrated the significant differences between AA-PET and standard MRI concerning the definition of the gross tumor volume (GTV). A small single-center non-randomized prospective study in patients with recurrent high grade gliomas treated with stereotactic fractionated radiotherapy (SFRT) showed a significant improvement in survival when AA-PET was integrated in target volume delineation, in comparison to patients treated based on CT/MRI alone. This protocol describes a prospective, open label, randomized, multi-center phase II trial designed to test if radiotherapy target volume delineation based on FET-PET leads to improvement in progression free survival (PFS) in patients with recurrent glioblastoma (GBM) treated with re-irradiation, compared to target volume delineation based on T1Gd-MRI. The target sample size is 200 randomized patients with a 1:1 allocation ratio to both arms. The primary endpoint (PFS) is determined by serial MRI scans, supplemented by AA-PET-scans and/or biopsy/surgery if suspicious of progression. Secondary endpoints include overall survival (OS), locally controlled survival (time to local progression or death), volumetric assessment of GTV delineated by either method, topography of progression in relation to MRI- or PET-derived target volumes, rate of long term survivors (>1 year), localization of necrosis after re-irradiation, quality of life (QoL) assessed by the EORTC QLQ-C15 PAL questionnaire, evaluation of safety of FET-application in AA-PET imaging and toxicity of re-irradiation. This is a protocol of a randomized phase II trial designed

  13. Efficacy and safety of combination therapy with latanoprost after a change in therapeutic regimen from timolol to brinzolamide in Japanese adult patients with primary open-angle glaucoma and ocular hypertension: open, non-randomized 12-week study

    Directory of Open Access Journals (Sweden)

    Shusaku Ishikawa

    2008-09-01

    Full Text Available Shusaku Ishikawa1, Yoshimi Nakamura1, Yuko Nakamura1, Hiroshi Sakai1, Shoichi Sawaguchi1, Kazuo Terashima2, Makoto Kanno2, Hidetoshi Yamashita21Department of Ophthalmology, University of the Ryukyus Faculty of Medicine, Okinawa, Japan; 2Department of Ophthalmology and Visual Science, Yamagata University Faculty of Medicine, Yamagata, JapanPurpose: To compare the efficacy of brinzolamide in Japanese patients with primary open-angle glaucoma (POAG or ocular hypertension (OH after a change from timolol in combination therapy with latanoprost.Methods: A 12-week, prospective, open-label, comparative study was performed in 20 patients [11 males and 9 females, mean age of 64.5 ± 11.0 (SDy] with POAG or OH treated with both latanoprost once daily and timolol 0.5% twice daily. During the study brinzolamide was substituted for timolol. Intraocular pressure (IOP was measured at baseline, 4, 8, and 12 weeks. Blood pressure (BP, pulse rate (PR, and adverse events were also recorded.Results: IOPs at baseline, 4, 8, and 12 weeks were 18.6 ± 2.1 mmHg, 17.8 ± 2.6 mmHg, 17.4 ± 2.5 mmHg, and 17.3 ± 3.5 mmHg, respectively. IOP reduction at 4 and 8 weeks was statistically significant (p < 0.05. The PR was significantly increased at 12 weeks (p < 0.01, but BP was not significantly affected. Four ocular adverse events were noted, but all were mild and transient.Conclusions: Substituting brinzolamide 1% for timolol 0.5% in combination therapy with latanoprost 0.005% demonstrated significant IOP reduction with improvement in PR with POAG or OH. Combination therapy using latanoprost and brinzolamide may be recommended for better IOP control with fewer systemic adverse events.Keywords: open-angle glaucoma, brinzolamide/latanprost combination therapy, timolol/latanoprost combination therapy, intraocular pressure

  14. Prospects in nuclear medicine

    International Nuclear Information System (INIS)

    Pink, V.; Johannsen, B.; Muenze, R.

    1990-01-01

    In nuclear medicine, a sequence of revolutioning research up to the simple and efficient application in routine has always then taken place when in an interdisciplinary teamwork new radiochemical tracers and/or new instrumentation had become available. At present we are at the beginning of a phase that means to be in-vivo-biochemistry, the targets of which are molecular interactions in the form of enzymatic reactions, ligand-receptor interactions or immunological reactions. The possibility to use positron-emitting radionuclides of bioelements in biomolecules or drugs to measure their distribution in the living organism by positron-emission tomography (PET) is gaining admittance into the pretentious themes of main directions of medical research. Diagnostic routine application of biochemically oriented nuclear medicine methods are predominantly expected from the transmission of knowledge in PET research to the larger appliable emission tomography with gamma-emitting tracers (SPECT). (author)

  15. Tale of three prospects

    Science.gov (United States)

    Duffield, Wendell A.; ,

    1992-01-01

    Most high-temperature, hydrothermal-convection systems probably are heated by bodies of magma (and/or hot plutons), whose presence is suggested by geologically young, if not active volcanism. Study of a young volcanic area provides information about the general thermal status of the underlying heat source, and detailed information about the time-space-volume-composition (TSVC) characteristics for a volcanic area can help define temperature at least semi-quantitatively when interpreted within the framework of published magma-cooling models. Thus, TSVC study is a fairly powerful and cost effective tool in the pre-drilling phase of an exploration program in young volcanic terrane. Examples are described for Coso, California; Agua de Pau, Azores; and Tecuamburro, Guatemala.

  16. Major prospects of micro-grids in modern power systems

    International Nuclear Information System (INIS)

    Raza, M.Q.; Rashid, A.; Ali, M.

    2011-01-01

    The paper under study presents the concept of major prospects of non autonomous micro grids installed in a certain locality. This paper is divided into three main phases. Phase one shows the basic background that is required for the installment of micro grid in a particular area. This section discusses the primary factors or prerequisites that are required for the existence and operation of micro grids. Phase two elaborates the major profitable applications and benefits that developing and developed states get by using micro grids in an area where utility grid is already functioning. Final phase explains the basic improvement in the quality of supply from micro grid after its installment. It also throws light on afterwards impact on society with this system; such impacts include reliability, tariff rates, economics etc. (author)

  17. Scalable WDM phase regeneration in a single phase-sensitive amplifier through optical time lenses

    DEFF Research Database (Denmark)

    Guan, Pengyu; Da Ros, Francesco; Lillieholm, Mads

    2018-01-01

    elusive, constituting a key challenge, which must be overcome for optical regeneration to have any prospect of being adapted in actual communication systems. Here we report a scalable wavelength-division multiplexing (WDM) regeneration scheme for phase only regeneration, which satisfies the multichannel...

  18. Phased array control using phase-locked-loop phase shifters

    Science.gov (United States)

    Houghton, A. W.; Brennan, P. V.

    1992-02-01

    The work investigates the use of phase-locked loops (PLLs) as phase shifters in the control of a phased antenna array. The phase error of a PLL can be altered by adding a dc offset voltage to the output of the phase detector. If a digital phase detector, with its inherently linear response, is used, then the phase error, and hence the relative phase shift, will vary linearly with applied control voltage. Such phase shifters can act on their own at VHF or they can provide an IF reference signal to a mixer to create a linear phase shifter at microwave frequencies. Four prototype phase shifters, fed in series, have been built, driving a linear array of four monopoles, in transmit mode at 1.5 GHz. By use of a single common control voltage, a single main beam can be swept through 180 deg with an accuracy of better than +/- 2 deg within the range +/- 70 deg.

  19. Prospects for Accelerator Technology

    Science.gov (United States)

    Todd, Alan

    2011-02-01

    Accelerator technology today is a greater than US$5 billion per annum business. Development of higher-performance technology with improved reliability that delivers reduced system size and life cycle cost is expected to significantly increase the total accelerator technology market and open up new application sales. Potential future directions are identified and pitfalls in new market penetration are considered. Both of the present big market segments, medical radiation therapy units and semiconductor ion implanters, are approaching the "maturity" phase of their product cycles, where incremental development rather than paradigm shifts is the norm, but they should continue to dominate commercial sales for some time. It is anticipated that large discovery-science accelerators will continue to provide a specialty market beset by the unpredictable cycles resulting from the scale of the projects themselves, coupled with external political and economic drivers. Although fraught with differing market entry difficulties, the security and environmental markets, together with new, as yet unrealized, industrial material processing applications, are expected to provide the bulk of future commercial accelerator technology growth.

  20. LUNA: Status and prospects

    Science.gov (United States)

    Broggini, C.; Bemmerer, D.; Caciolli, A.; Trezzi, D.

    2018-01-01

    The essential ingredients of nuclear astrophysics are the thermonuclear reactions which shape the life and death of stars and which are responsible for the synthesis of the chemical elements in the Universe. Deep underground in the Gran Sasso Laboratory the cross sections of the key reactions responsible for the hydrogen burning in stars have been measured with two accelerators of 50 and 400 kV voltage right down to the energies of astrophysical interest. As a matter of fact, the main advantage of the underground laboratory is the reduction of the background. Such a reduction has allowed, for the first time, to measure relevant cross sections at the Gamow energy. The qualifying features of underground nuclear astrophysics are exhaustively reviewed before discussing the current LUNA program which is mainly devoted to the study of the Big-Bang nucleosynthesis and of the synthesis of the light elements in AGB stars and classical novae. The main results obtained during the study of reactions relevant to the Sun are also reviewed and their influence on our understanding of the properties of the neutrino, of the Sun and of the Universe itself is discussed. Finally, the future of LUNA during the next decade is outlined. It will be mainly focused on the study of the nuclear burning stages after hydrogen burning: helium and carbon burning. All this will be accomplished thanks to a new 3.5 MV accelerator able to deliver high current beams of proton, helium and carbon which will start running under Gran Sasso in 2019. In particular, we will discuss the first phase of the scientific case of the 3.5 MV accelerator focused on the study of 12C+12C and of the two reactions which generate free neutrons inside stars: 13C(α,n)16O and 22Ne(α,n)25Mg.

  1. Domestic kraudfandinh: problems and prospects

    Directory of Open Access Journals (Sweden)

    L.V. Mihalchuk

    2015-03-01

    Full Text Available The description kraudfandinh as an innovative tool to attract private investment in promising business projects as a special type of financing over the Internet. Powered its classification and kraud lists of successful projects, clearly illustrated by comparison of the normal business process to create a product and a similar process using kraudfandinh, given the differences between them and the main advantages. Based on the summaries of the literature and current practices of foreign companies and kraud platforms, defined the prospects of its application by domestic enterprises in various industries, proved its positive impact on the economy of Ukraine. The main problem of the use of this instrument in the domestic business, according to national circumstances, given their explanations. Described the prospects for its implementation at Ukrainian enterprises in terms of economic instability. The characteristic of the first Ukrainian kraudfandinh platforms by their future prospects in this direction

  2. Geometric phases and quantum computation

    International Nuclear Information System (INIS)

    Vedral, V.

    2005-01-01

    Full text: In my lectures I will talk about the notion of the geometric phase and explain its relevance for both fundamental quantum mechanics as well as quantum computation. The phase will be at first introduced via the idea of Pancharatnam which involves interference of three or more light beams. This notion will then be generalized to the evolving quantum systems. I will discuss both pure and mixed states as well as unitary and non-unitary evolutions. I will also show how the concept of the vacuum induced geometric phase arises in quantum optics. A simple measurement scheme involving a Mach Zehnder interferometer will be presented and will be used to illustrate all the concepts in the lecture. Finally, I will expose a simple generalization of the geometric phase to evolving degenerate states. This will be seen to lead to the possibility of universal quantum computation using geometric effects only. Moreover, this contains a promise of intrinsically fault tolerant quantum information processing, whose prospects will be outlined at the end of the lecture. (author)

  3. Prospective observational study comparing traditional laparoscopy and three-dimensional laparoscopy in gynecologic surgery.

    Science.gov (United States)

    Lara-Domínguez, Maria D; López-Jiménez, Araceli; Grabowski, Jacek P; Arjona-Berral, Jose E; Zapardiel, Ignacio

    2017-03-01

    To compare perioperative details among patients who underwent gynecologic surgery between traditional laparoscopy and three-dimensional laparoscopy. The present prospective non-randomized study enrolled all consecutive patients diagnosed with gynecologic pathology who underwent laparoscopic surgery at Reina Sofia Hospital, Cordoba, Spain between January 1 and April 30, 2014. Perioperative data, adverse events, and patient satisfaction were compared between patients who underwent treatment with two-dimensional and three-dimensional laparoscopic surgery techniques. The study enrolled 60 consecutive patients; 31 (52%) patients who underwent three-dimensional surgery and 29 (48%) who underwent traditional two-dimensional surgery. No significant differences were observed in the adverse-event rate, operating time, or perioperative parameters. A higher use of sealing devices was recorded among patients who underwent three-dimensional laparoscopy (P=0.021). No difference was recorded in patient satisfaction between the two patient groups. Although there was no impact on surgical outcomes, three-dimensional surgery could give a more accurate view of the surgical field. Performing three-dimensional surgery could be beneficial for more complex procedures although further comparative studies are required to investigate this hypothesis. © 2016 International Federation of Gynecology and Obstetrics.

  4. Rose breeding: past, present, prospects

    NARCIS (Netherlands)

    Vries, de D.P.; Dubois, L.A.M.

    1996-01-01

    In this review the PAST, PRESENT and PROSPECT will be considered as three separate periods in the history of the breeding and development of rose cultivars. The recurring theme is the genetic variation. This theme was chosen because there is justified doubt as to sufficient genetic variation

  5. Machine Translation: Developments and Prospects.

    Science.gov (United States)

    Russell, Robert A.

    1985-01-01

    Examines the history and resurgence of machine translation, describing metalanguages and transfer languages as algorithms for transforming source languages into target languages and reviewing prospects for the future. Indicates that leadership in this field is held by Japan for both hardware and software development for Japanese/English…

  6. Scientific knowledge and modern prospecting

    Science.gov (United States)

    Neuerburg, G.J.

    1985-01-01

    Modern prospecting is the systematic search for specified and generally ill-exposed components of the Earth's crust known as ore. This prospecting depends entirely on reliable, or scientific knowledge for guidance and for recognition of the search objects. Improvement in prospecting results from additions and refinements to scientific knowledge. Scientific knowledge is an ordered distillation of observations too numerous and too complex in themselves for easy understanding and for effective management. The ordering of these observations is accomplished by an evolutionary hierarchy of abstractions. These abstractions employ simplified descriptions consisting of characterization by selected properties, sampling to represent much larger parts of a phenomenon, generalized mappings of patterns of geometrical and numerical relations among properties, and explanation (theory) of these patterns as functional relations among the selected properties. Each abstraction is predicated on the mode of abstraction anticipated for the next higher level, so that research is a deductive process in which the highest level, theory, is indispensible for the growth and refinement of scientific knowledge, and therefore of prospecting methodology. ?? 1985 Springer-Verlag.

  7. Saudi Arabia: Problems and prospects

    International Nuclear Information System (INIS)

    Granata, V.; Palermo, M.

    1993-01-01

    Saudi Arabia has a central role in the world oil market. After analyzing the country's political and economic situation with all its possible outgrowths, this article indicates the various development prospects relevant to Saudi oil production and its future impacts on the market

  8. Autism Research: Prospects and Priorities.

    Science.gov (United States)

    Rutter, Michael

    1996-01-01

    Research prospects and priorities in autism are discussed with respect to: (1) diagnosis, classification, and epidemiology; (2) clinical research; (3) neuropsychological research; (4) genetics; (5) structural and functional brain imaging; (6) postmortem studies; (7) other biological research; and (8) treatment research. Application of research…

  9. Questions for Your Prospective Massage Therapist

    Science.gov (United States)

    ... Your Prospective Massage Therapist Questions for Your Prospective Massage Therapist Searching for a massage therapist? Get the ... 1. Are you a member of the American Massage Therapy Association (AMTA)? AMTA members commit to the ...

  10. Mathematical geology studies of deposit prospect types

    International Nuclear Information System (INIS)

    Liu Guangping

    1998-08-01

    Exact certainty prospect type of uranium deposit, not only can assure the quality of deposit prospects, but also increase economic benefits. Based on the standard of geological prospect of uranium deposit, the author introduces a method of Fuzzy Synthetical Comment for dividing prospect type of uranium deposit. The practical applications demonstrate that the regression accuracy, discriminated by Zadeh operator, of 15 known deposits is 100%

  11. Strategy and Prospects for Nuclear Energy in Europe

    International Nuclear Information System (INIS)

    Upson, P. C.

    1998-01-01

    Nuclear power has, for many years, played a vital role in helping the European Union meet its energy and environmental objectives. Today, however, power station construction programmes are at a virtual standstill, with little or no prospect of a restart in the foreseeable future; some member states have, in fact, taken the decision to phase out nuclear when plants currently operating reach the end of their life, if not before. Against this unpromising background, the nuclear industry is taking vigorous steps to improve its competitiveness, ensure the safety of nuclear plants operating in parts of East Europe, win business in a challenging export market and develop new technology that will build on already high standards of plant performance and safety. In reviewing the situation, the author touches upon the factors and circumstances that are likely to impact favourably or unfavourably on the industry's efforts to secure its long-term future and ends by summing up the prospects for success. (author)

  12. Rush sublingual immunotherapy in canine atopic dermatitis: a prospective pilot study.

    Science.gov (United States)

    Fujimura, M; Ishimaru, H

    2016-01-01

    Twenty dogs with canine atopic dermatitis (CAD) were treated with rush sublingual immunotherapy (SLIT), with a 48 hour build-up phase and 6 months maintenance phase (treated by antigen once every 3-4 weeks). The canine atopic dermatitis extent and severity index (CADESI)-4 was evaluated before treatment (baseline) and after 6 months. An open, non-controlled, non-randomized pilot trial was conducted to assess the effectiveness and safety of rush SLIT for environmental allergen extracts (Dematophagoides pteronyssinus and D.farinae mix and other). Three dogs dropped out and 17 dogs finished the trial. CADESI-4 at baseline was 60.6±27.1 (range 17-107, n=17). After 6 months of SLIT treatment, CADESI-4 was 37.4±36.0 (range 5-152, n=17) (p30%, was observed in 13 out of 17 dogs (76%). A moderate improvement, defined as a CADESI-4 reduction of ≦30%, was observed in 2 dogs (12%). In the other 2 dogs (12%), CADESI-4 worsened or showed no change. However, no severe adverse effects were observed during the trial. Therefore, rush SLIT against environmental allergen extract for CAD showed effectiveness and safety as evidenced by the reduction of CADESI-4 after 6 months SLIT without severe adverse effects.

  13. Phase contrast image synthesis

    DEFF Research Database (Denmark)

    Glückstad, J.

    1996-01-01

    A new method is presented for synthesizing arbitrary intensity patterns based on phase contrast imaging. The concept is grounded on an extension of the Zernike phase contrast method into the domain of full range [0; 2 pi] phase modulation. By controlling the average value of the input phase funct...... function and by choosing appropriate phase retardation at the phase contrast filter, a pure phase to intensity imaging is accomplished. The method presented is also directly applicable in dark field image synthesis....

  14. Uranium prospecting and uranium supply

    International Nuclear Information System (INIS)

    Kegel, K.E.

    1975-01-01

    Following of short historical survey, estimations of the uranium resources of the western world made in the middle of 1975 are presented and interpreted. The most common methods of prospecting and exploration of the mines and of production and processing of the uranium eres are described. A short survey of the situation of supply and demand is supplemented by a description of the activities of the two German companies in the field of uranium supply. (UA/AK) [de

  15. The use of probiotics in different phases of diverticular disease.

    Science.gov (United States)

    Ojetti, Veronica; Petruzziello, Carmine; Cardone, Silvia; Saviano, Luisa; Migneco, Alessio; Santarelli, Luca; Gabrielli, Maurizio; Zaccaria, Raffaella; Lopetuso, Loris; Covino, Marcello; Candelli, Marcello; Gasbarrini, Antonio; Franceschi, Francesco

    2018-04-02

    Diverticular Disease (DD) is a common clinical condition with a dramatic increasing of the prevalence among industrialized countries. Based on the most used classification, DD may be divided into asymptomatic diverticulosis, symptomatic uncomplicated diverticular disease and complicated diverticular disease. Since recent studies pointed out the role of GUT microbiota imbalance in promoting diverticular formation and inflammation, we have designed a systematic review focusing on the possible role of probiotics in the management of this condition. According to PRISMA, we identified studies on DD patients treated with probiotics, by searching on Pubmed, Embase, Cochrane and ResearchGate Results: 13 studies were included in this review based on our selection criteria: 3 double-blind randomized placebo-controlled, 6 open randomized, and 4 non-randomized open studies. This is the first systematic review providing an updated measure of evidence on the efficacy of probiotics in different phase of DD. Even though the majority of studies are still preliminary, current data show a possible clinical application of certain probiotic strains in all stages of DD. Further investigation is then required to better understand when and how probiotics can be used in different phases of DD. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  16. Prospects for oil and gas

    International Nuclear Information System (INIS)

    Laherrere, J.

    2011-01-01

    It was five years ago, in January 2006, that Futuribles devoted a major special issue (no. 315) to energy prospects and the greenhouse effect. That was already a time of great concern about this question and several articles offered analyses of the gloomy prospects for the development of energy resources and the issues around climate change. Among these, an article by Jean Laherrere outlined the prospects for oil resources, showing the extent to which information in this area was disparate, unreliable and even questionable, being often highly political. As one of the more pessimistic writers on the question, Laherrere reminded us of the imminence of 'peak oil' (the prelude to a decline in global oil production) and the need to re-think our styles of consumption to adapt to a new age in which, as energy becomes scarcer, it will be increasingly expensive. Five years later, Jean Laherrere returns to the columns of Futuribles on the occasion of a new special issue on energy and the climate, to update us on the global prospects for oil and gas production. He begins by recalling how politically slanted and unreliable information in this area can be, depending on its source, the units of measurement employed etc. He stresses, too, that in the view of many experts peak oil was reached in 2006 and the situation is currently plateau-ing, just ahead of a decline in oil production (gradual or sudden, depending on whether measures of economic constraint are implemented). For its part, gas production should peak around 2025-2030. Jean Laherrere specifies what reserves remain, how these are currently exploited and marketed, and the prospects that ensue in the longer term (he also shows how wrong gas-price forecasts have been in the past). As he stresses, in conclusion, with both oil and gas we must be aware that the world does not have infinite resources and, since the alternatives do not allow us, at the moment, to make up for future energy-resource shortages, it is for

  17. PROSPECTS

    African Journals Online (AJOL)

    IOne of the most challenging issues in respect of. Nigerian creative writing in French is that of audience or readership for the finished product. Onyeanulam, cited by. Edung (t997:133), opines that Nigerian literature can and should be written for both internal and external audiences: This is reechoed in Ojo-Ade's comment on ...

  18. PROSPECT: A Short-baseline Reactor Precision Spectrum and Oscillation Experiment

    Science.gov (United States)

    Langford, Thomas; Prospect Collaboration

    2015-10-01

    PROSPECT is a phased experiment consisting of segmented Li-loaded liquid scintillator antineutrino detectors designed to probe short-baseline neutrino oscillations and precisely measure the reactor antineutrino spectrum. The experiment will be located at the High Flux Isotope Reactor (HFIR) at Oak Ridge National Lab. The first phase is a movable 2.5 tonne detector located 7-9 m from the compact, highly enriched uranium (HEU) core. Over the past two years, PROSPECT has deployed multiple prototype detectors at HFIR to understand the local background environment and demonstrate active and passive background rejection. Measuring the neutrino spectrum from 235U will give insight to the recent spectral discrepancies and provide an important benchmark for future reactor experiments. As a high statistics experiment, PROSPECT will probe the sterile neutrino best-fit region within one year of operation at HFIR.

  19. Distress in suspected lung cancer patients following rapid and standard diagnostic programs : a prospective observational study

    NARCIS (Netherlands)

    Brocken, Pepijn; van der Heijden, Erik H. F. M.; Oud, Karen T. M.; Bootsma, Gerben; Groen, Harry J. M.; Donders, A. Rogier T.; Dekhuijzen, P. N. Richard; Prins, Judith B.

    ObjectiveTimeliness may influence emotional distress during the diagnostic phase of suspected lung cancer patients. We performed a prospective observational study to compare distress and quality of life (QoL) in two medical centres with a Rapid Outpatient Diagnostic Program (RODP) and two using

  20. A Prospective Cohort Study on IRS Gene Polymorphisms in Type 2 ...

    African Journals Online (AJOL)

    http://dx.doi.org/10.4314/tjpr.v13i6.10. Original Research Article. A Prospective Cohort Study on IRS Gene Polymorphisms in Type 2 Diabetes Mellitus Patients during Severe/Acute. Hyperglycemia Phase 1: Association with Insulin. Resistance. Hasniza Zaman Huri1,2*, Mohd Makmor-Bakry3, Rosnani Hashim4, Norlaila.

  1. Non-Random Missingness in Categorical Data: Strengths and Limitations

    OpenAIRE

    Molenberghs, Geert; Goetghebeur, Els J.T.; Lipsitz, Stuart R.; Kenward, Michael G.

    1999-01-01

    There have recently been substantial developments in the analysis of incomplete data. Modeling tools are now available for nonrandom missingness and these methods are finding their way into the broad statistical community. The computational and interpretational issues that surround such models are less well known. This article provides an exposition of several of these issues in a categorical data setting. It is argued that the use of contextual information can aid the modeler in discriminati...

  2. A Non-Random Walk Down Hollywood Boulevard

    DEFF Research Database (Denmark)

    Lepori, Gabriele

    Media communication scholars document that the general public exhibits a psychological attachment to celebrities and may emotionally react to their death. In this paper, I take advantage of this insight and I adopt an event study approach to test the impact of exogenous and incidental negative...

  3. How a dependent's variable non-randomness affects taper equation ...

    African Journals Online (AJOL)

    In order to apply the least squares method in regression analysis, the values of the dependent variable Y should be random. In an example of regression analysis linear and nonlinear taper equations, which estimate the diameter of the tree dhi at any height of the tree hi, were compared. For each tree the diameter at the ...

  4. A Non-Random Walk Down Hollywood Boulevard

    DEFF Research Database (Denmark)

    Lepori, Gabriele

    affect (i.e. grief, proxied by the death of Hollywood Walk of Fame celebrities) on people’s willingness to invest in risky assets (proxied by the daily performance of the U.S. stock market). Using a sample of 1,374 celebrity deaths over the period 1926-2009 and controlling for seasonalities, economic...... is increasing in the popularity/media coverage of the celebrity in question, and is larger for stocks that are more affected by investor sentiment. Overall, my findings are consistent with the lab research on the affect management model, which maintains that incidental negative affect promotes risk....../environmental factors, and market liquidity, I find that the death of popular and beloved celebrities is immediately followed by a 16 basis point increase in stock returns, which is consistent with a rise in the net demand for risky instruments. I also find evidence that the size of this celebrity-death effect...

  5. EEG phase states at stimulus onset in a variable-ISI Go/NoGo task: Effects on ERP components.

    Science.gov (United States)

    Barry, Robert J; Fogarty, Jack S; De Blasio, Frances M; Karamacoska, Diana

    2018-04-01

    Previous EEG-ERP dynamics studies found non-random "preferred" EEG phases at stimulus onset in a fixed interstimulus interval (ISI) equiprobable auditory Go/NoGo paradigm, with substantial effects on ERP components. Here we changed to a variable ISI task to prevent/reduce preferential phase occurrence. Discrete Fourier transforms decomposed prestimulus EEG at Cz for each trial to calculate the phase of different frequencies at stimulus onset; we combined these into the delta, theta, alpha, and beta bands, and then sorted trials into phase quartiles for each. ERPs from the raw EEG, assessed using temporal Principal Components Analyses, were examined as a function of phase at stimulus onset. Preferential phase occurrence was reduced as predicted, but random phase substantially impacted component amplitudes. For example, negativity in delta enhanced Go and NoGo P3b; and in theta reduced NoGo but not Go P3b. Overall, EEG phases at stimulus onset support differential cognitive processing in this two-choice task. Copyright © 2018 Elsevier B.V. All rights reserved.

  6. Omega phase in materials

    International Nuclear Information System (INIS)

    Sikka, S.K.; Vohra, Y.K.; Chidambaram, R.

    1982-01-01

    The subject is reviewed under the headings: introduction; occurrence and some systematics of omega phase; crystallography; physical properties; kinetics of formation, synthesis and metastability of omega phase; electronic structure of omega phase; electronic basis for omega phase stability; omega phase formation under combined thermal and pressure treatment in alloys; transformation mechanisms and models for diffuse omega phase; conclusion. The following elements of nuclear interest (or their alloys) are included: Zr, Hf, Nb, V, Mo. (U.K.)

  7. Phase equilibrium engineering

    CERN Document Server

    Brignole, Esteban Alberto

    2013-01-01

    Traditionally, the teaching of phase equilibria emphasizes the relationships between the thermodynamic variables of each phase in equilibrium rather than its engineering applications. This book changes the focus from the use of thermodynamics relationships to compute phase equilibria to the design and control of the phase conditions that a process needs. Phase Equilibrium Engineering presents a systematic study and application of phase equilibrium tools to the development of chemical processes. The thermodynamic modeling of mixtures for process development, synthesis, simulation, design and

  8. Safety and efficacy of combination therapy of interferon-alpha2 + JAK1-2 Inhibitor in the philadelphia-negative chronic myeloproliferative neoplasms. Preliminary results from the danish combi-trial-an open label, single arm, non-randomized multicenter phase II study

    DEFF Research Database (Denmark)

    Mikkelsen, S. U.; Kjaer, L.; Skov, V.

    2015-01-01

    Background: The Philadelphia-negative, chronic myeloproliferative neoplasms (MPN) include essential thrombocythemia (ET), polycythemia vera (PV) and primary myelofibrosis (MF) (PMF). Chronic inflammation and a deregulated immune system are considered important for clonal evolution and disease pro...

  9. Prospective memory across the lifespan: investigating the contribution of retrospective and prospective processes.

    Science.gov (United States)

    Mattli, Florentina; Schnitzspahn, Katharina M; Studerus-Germann, Aline; Brehmer, Yvonne; Zöllig, Jacqueline

    2014-01-01

    Prospective memory performance follows an inverted U-shaped function across the lifespan. Findings on the relative contribution of purely prospective memory and retrospective memory processes within prospective memory to this trajectory are scarce and inconclusive. We analyzed age-related differences in prospective memory performance across the lifespan in a cross-sectional design including six age groups (N = 99, 7-83 years) and investigated possible mechanisms by experimentally disentangling the relative contributions of retrospective memory and purely prospective memory processes. Results confirmed the inverted U-shaped function of prospective memory performance across the lifespan. A significant interaction between process type and age group was observed indicating differential relative contributions of retrospective memory and purely prospective memory processes on the development of prospective memory performance. Our results showed that mainly the pure prospective memory processes within prospective memory lead to lower prospective memory performance in young children and old adults. Moreover, the relative contributions of the retrospective memory and purely prospective memory processes are not uniform at both ends of the lifespan, i.e., in later adulthood the purely prospective memory processes seem to determine performance to an even greater extent than in childhood. Nevertheless, age effects were also observed in the retrospective component which thus contributed to the prospective memory performance differences between the age groups.

  10. 'I-tese newsletter Number 15 Spring 2012: an assessment of the 'phasing-out-nuclear cost' in France; Prospective: a posture in the service of man to help him in shaping the future; Climate in UNO: heading for a new multilateral agreement?; Electric mobility with fuel cell: which target price(s) for hydrogen at the pump? Does the 'real production cost' of the present electronuclear fleet exist?; La lettre de l'I-tese Numero 15 Printemps 2012: Une evaluation du 'cout de sortie' du nucleaire en France; La prospective: une attitude au service de l'homme pour l'aider a faconner l'avenir; Climat a l'ONU: cap sur un nouvel accord multilateral?; Mobilite electrique a Pile a Combustible: quelle(s) cible(s) de prix pour l'hydrogene a la pompe? Le 'vrai cout de production' du parc electronucleaire actuel existe-t-il?

    Energy Technology Data Exchange (ETDEWEB)

    Dautremont, Severine; Devezeaux de Lavergne, Jean-Guy; Colle, Francois Xavier; Popiolek, Nathalie; Thais, Francoise; Le Duigou, Alain; Duquesnoy, Thierry; Sabourin, Didier

    2011-04-01

    Based on the definition of two scenarios (a reference scenario with a steady power, and phasing out nuclear), a first article discusses the assessment of the cost of phasing out nuclear for France. A second article comments the importance given to prospective studies which more particularly emerged in the United States after World War II. This article is followed by another one which addresses the peculiar case of energetic prospective studies which can be perceived as a battle of scenarios. An article discusses the need of a new agreement on climate after the Durban conference. The next article discusses how to characterize the competitiveness of hydrogen used in fuel cells in the transport sector. Then, an author comments a report by the French Revenue Court about the initial investment costs of the electronuclear fleet, present operation expenses, maintenance costs and provisions for future expenses

  11. Prospects for inherently safe reactors

    International Nuclear Information System (INIS)

    Barkenbus, J.N.

    1988-01-01

    Public fears over nuclear safety have led some within the nuclear community to investigate the possibility of producing inherently safe nuclear reactors; that is, reactors that are transparently incapable of producing a core melt. While several promising designs of such reactors have been produced, support for large-scale research and development efforts has not been forthcoming. The prospects for commercialization of inherently safe reactors, therefore, are problematic; possible events such as further nuclear reactor accidents and superpower summits, could alter the present situation significantly. (author)

  12. Renewable energy prospects for implementation

    CERN Document Server

    Jackson, Tim

    1993-01-01

    Renewable Energy: Prospects for Implementation contains papers that were originally commissioned by the journal Energy Policy for a series on renewable energy appearing between January 1991 to September 1992. In view of the fast-changing demands on conventional energy supply to meet environmental imperatives, it seemed timely to reproduce here a selection of those papers with a new introduction and a revised concluding chapter by the Editor of the series, Dr Tim Jackson, a research fellow with the Stockholm Environment Institute. The book is organized into four parts. The papers in Part I

  13. Usefulness of acute phase proteins for monitoring development of ...

    African Journals Online (AJOL)

    Background: Serum levels of acute phase proteins (APP) have been used to diagnose and follow up treatment of liver diseases. This study was carried out to determine the usefulness of APP to predict development of hepatocellular carcinoma (HCC) among Hepatitis B virus (HBV) carriers. Study design: In a prospective ...

  14. Solid-phase oligosaccharide and glycopeptide synthesis using glycosynthases

    DEFF Research Database (Denmark)

    Tolborg, Jakob Fjord; Petersen, Lars; Jensen, Knud Jørgen

    2002-01-01

    and the prospect of automatability. Here, we report the first application of glycosynthases to solid-phase oligosaccharide synthesis by use of the 51 kDa serine and glycine mutants of Agrobacterium sp. beta-glucosidase, Abg E358S and E358G. Acceptors were linked to PEGA resin through a backbone amide linker (BAL...

  15. Fourier phasing with phase-uncertain mask

    International Nuclear Information System (INIS)

    Fannjiang, Albert; Liao, Wenjing

    2013-01-01

    Fourier phasing is the problem of retrieving Fourier phase information from Fourier intensity data. The standard Fourier phase retrieval (without a mask) is known to have many solutions which cause the standard phasing algorithms to stagnate and produce wrong or inaccurate solutions. In this paper Fourier phase retrieval is carried out with the introduction of a randomly fabricated mask in measurement and reconstruction. Highly probable uniqueness of solution, up to a global phase, was previously proved with exact knowledge of the mask. Here the uniqueness result is extended to the case where only rough information about the mask’s phases is assumed. The exponential probability bound for uniqueness is given in terms of the uncertainty-to-diversity ratio of the unknown mask. New phasing algorithms alternating between the object update and the mask update are systematically tested and demonstrated to have the capability of recovering both the object and the mask (within the object support) simultaneously, consistent with the uniqueness result. Phasing with a phase-uncertain mask is shown to be robust with respect to the correlation in the mask as well as the Gaussian and Poisson noises. (paper)

  16. CrowdPhase: crowdsourcing the phase problem

    International Nuclear Information System (INIS)

    Jorda, Julien; Sawaya, Michael R.; Yeates, Todd O.

    2014-01-01

    The idea of attacking the phase problem by crowdsourcing is introduced. Using an interactive, multi-player, web-based system, participants work simultaneously to select phase sets that correspond to better electron-density maps in order to solve low-resolution phasing problems. The human mind innately excels at some complex tasks that are difficult to solve using computers alone. For complex problems amenable to parallelization, strategies can be developed to exploit human intelligence in a collective form: such approaches are sometimes referred to as ‘crowdsourcing’. Here, a first attempt at a crowdsourced approach for low-resolution ab initio phasing in macromolecular crystallography is proposed. A collaborative online game named CrowdPhase was designed, which relies on a human-powered genetic algorithm, where players control the selection mechanism during the evolutionary process. The algorithm starts from a population of ‘individuals’, each with a random genetic makeup, in this case a map prepared from a random set of phases, and tries to cause the population to evolve towards individuals with better phases based on Darwinian survival of the fittest. Players apply their pattern-recognition capabilities to evaluate the electron-density maps generated from these sets of phases and to select the fittest individuals. A user-friendly interface, a training stage and a competitive scoring system foster a network of well trained players who can guide the genetic algorithm towards better solutions from generation to generation via gameplay. CrowdPhase was applied to two synthetic low-resolution phasing puzzles and it was shown that players could successfully obtain phase sets in the 30° phase error range and corresponding molecular envelopes showing agreement with the low-resolution models. The successful preliminary studies suggest that with further development the crowdsourcing approach could fill a gap in current crystallographic methods by making it

  17. CrowdPhase: crowdsourcing the phase problem

    Energy Technology Data Exchange (ETDEWEB)

    Jorda, Julien; Sawaya, Michael R. [Institute for Genomics and Proteomics, 611 Charles Young Drive East, Los Angeles, CA 90095 (United States); Yeates, Todd O., E-mail: yeates@mbi.ucla.edu [Institute for Genomics and Proteomics, 611 Charles Young Drive East, Los Angeles, CA 90095 (United States); Molecular Biology Institute, 611 Charles Young Drive East, Los Angeles, CA 90095 (United States); University of California, 611 Charles Young Drive East, Los Angeles, CA 90095 (United States)

    2014-06-01

    The idea of attacking the phase problem by crowdsourcing is introduced. Using an interactive, multi-player, web-based system, participants work simultaneously to select phase sets that correspond to better electron-density maps in order to solve low-resolution phasing problems. The human mind innately excels at some complex tasks that are difficult to solve using computers alone. For complex problems amenable to parallelization, strategies can be developed to exploit human intelligence in a collective form: such approaches are sometimes referred to as ‘crowdsourcing’. Here, a first attempt at a crowdsourced approach for low-resolution ab initio phasing in macromolecular crystallography is proposed. A collaborative online game named CrowdPhase was designed, which relies on a human-powered genetic algorithm, where players control the selection mechanism during the evolutionary process. The algorithm starts from a population of ‘individuals’, each with a random genetic makeup, in this case a map prepared from a random set of phases, and tries to cause the population to evolve towards individuals with better phases based on Darwinian survival of the fittest. Players apply their pattern-recognition capabilities to evaluate the electron-density maps generated from these sets of phases and to select the fittest individuals. A user-friendly interface, a training stage and a competitive scoring system foster a network of well trained players who can guide the genetic algorithm towards better solutions from generation to generation via gameplay. CrowdPhase was applied to two synthetic low-resolution phasing puzzles and it was shown that players could successfully obtain phase sets in the 30° phase error range and corresponding molecular envelopes showing agreement with the low-resolution models. The successful preliminary studies suggest that with further development the crowdsourcing approach could fill a gap in current crystallographic methods by making it

  18. Uranium prospecting using radon (1963)

    International Nuclear Information System (INIS)

    Pradel, J.; Billard, F.; Miribel, J.; Gangloff, A.; Puybaraud, Y.; Tayeb, G.

    1963-01-01

    The radon which diffuses in the ground and which migrates in the atmosphere is a natural radioactive tracer. The study of its production can give useful information on the uranium content and structure of the rocks from which it comes. Numerous authors have therefore suggested that uranium deposits be prospected by means of this radon. Three analytic methods have been used successively by the C.E.A.: the method of accumulation in a hole, the method of instantaneous sampling in the ground, and the method of sampling by scanning. Only the last has proved interesting and has been the object of systematic studies. It consists in purging the measurement recipient with air drawn from the probe and in measuring the variations in activity with time and with the volume drawn up, using a portable apparatus producing scintillations in a sulphurated flask. The first series of measurements made it possible to develop an apparatus (flow rate, hole depth, scintillating probe) and to distinguish between tbe activities of the thoron and of the radon by making two measurements at an interval of 54 seconds. A campaign of systematic sampling was then carried out. It made It possible to show the good reproducibility of the results obtained and tbe good agreement with conventional methods. This method is the best one for areas having large overlap. In the appendix the detector and its mode of use are briefly described, and the first results of an emanometric prospecting test in the Vendee mining division are given. (authors) [fr

  19. Prospective Memory Development Through Childhood into Adolescence

    OpenAIRE

    Bialek, Anna Katarzyna

    2009-01-01

    The present study looked at prospective memory development between 7-15 years of age (N=57). Past research has draw no coherent picture of prospective memory development due to variations in prospective memory tasks employed, motivation not being suppressed, time-based and event-based memory not being distinguished and time delay between intention formation and intention execution not being controlled. The present study aimed to overcome these issues and draw a more coherent picture of prospe...

  20. Referenceless Phase Holography for 3D Imaging

    Science.gov (United States)

    Kreis, Thomas

    2017-12-01

    Referenceless phase holography generates the full (amplitude and phase) optical field if intensity and phase of this field are given as numerical data. It is based on the interference of two pure phase fields which are produced by reflection of two mutually coherent plane waves at two phase modulating spatial light modulators of the liquid crystal on silicon type. Thus any optical field of any real or artificial 3D scene can be displayed. This means that referenceless phase holography is a promising method for future 3D imaging, e. g. in 3D television. The paper introduces the theory of the method and presents three possible interferometer arrangements, for the first time the Mach-Zehnder and the grating interferometer adapted to this application. The possibilities and problems in calculating the diffraction fields of given 3D scenes are worked out, the best choice and modifications of the algorithms are given. Several novelty experimental examples are given proving the 3D cues depth of field, occlusion and parallax. The benefits and advantages over other holographic approaches are pointed out, open problems and necessary technological developments as well as possibilities and future prospects are discussed.

  1. A prospective, randomized, double blind controlled trial

    African Journals Online (AJOL)

    Effects of intravenous diclofenac on postoperative sore throat in patients undergoing laparoscopic surgery at Aga Khan University Hospital, Nairobi: A prospective, randomized, double blind controlled trial.

  2. Randomized, interventional, prospective, comparative study to ...

    African Journals Online (AJOL)

    Randomized, interventional, prospective, comparative study to evaluate the antihypertensive efficacy and tolerability of ramipril versus telmisartan in stage 1 hypertensive patients with diabetes mellitus.

  3. Low organisational justice and heavy drinking: a prospective cohort study.

    Science.gov (United States)

    Kouvonen, Anne; Kivimäki, Mika; Elovainio, Marko; Väänänen, Ari; De Vogli, Roberto; Heponiemi, Tarja; Linna, Anne; Pentti, Jaana; Vahtera, Jussi

    2008-01-01

    To investigate whether low perceived organisational injustice predicts heavy drinking among employees. Data from a prospective occupational cohort study, the 10-Town Study, on 15 290 Finnish public sector local government employees nested in 2432 work units, were used. Non-drinkers were excluded. Procedural, interactional and total organisational justice, heavy drinking (>/=210 g of absolute alcohol per week) and other psychosocial factors were determined by means of questionnaire in 2000-2001 (phase 1) and 2004 (phase 2). Multilevel logistic regression analyses taking into account the hierarchical structure of the data were conducted and adjustments were made for sex, age, socio-economic status, marital status, baseline heavy drinking, psychological distress and other psychosocial risk factors such as job strain and effort/reward imbalance. After adjustments, participants who reported low procedural justice at phase 1 were approximately 1.2 times more likely to be heavy drinkers at phase 2 compared with their counterparts reporting high justice. Low perceived justice in interpersonal treatment and low perceived total organisational justice were associated with increased prevalence of heavy drinking only in the model adjusted for sociodemographics. This is the first longitudinal study to show that low procedural justice is weakly associated with an increased likelihood of heavy drinking.

  4. Kenaf: its prospect in Indonesia

    Directory of Open Access Journals (Sweden)

    Estri Laras Arumingtyas

    2015-09-01

    Full Text Available Kenaf is a plant fibre with high potential as source of material industry. Originally, kenaf usage in Indonesia is still limited only for jute sacks material, which is then displaced by plastic sacks production. While at international scale, kenaf has been started to be developed as pulp material, polypropylene composite, fibreglass replacement, and particle board for automotive industry materials. Indonesia is a tropical country this condition which suitable for kenaf cultivation. However, research reports about kenaf potential usages are still few and limited in domestic level only. Whereas, Indonesian kenaf plant information is needed by international community to understand comprehensively about the potential of tropical plants. This article aims to provide an overview about kenaf cultivation potential and usages in Indonesia as well as the possibility of future development. Key words: kenaf, fibre, prospect, potential.

  5. Nuclear cooperation: challenges and prospects

    International Nuclear Information System (INIS)

    Ollapally, Deepa; Rajagopal, S.

    1997-01-01

    In this era of globalisation and technology flows, the nuclear field continues to retain strong barriers to international collaboration. From nuclear energy to non-proliferation however, the potential for concerted action exists. The International and Strategic Studies Unit of the National Institute of Advanced Studies (NIAS) held a two day seminar exploring the challenges and prospects for achieving mutual cooperation between states relating to all aspects of nuclear technology. This volume is based on the proceedings of the seminar. The broad themes that the seminar considered included disarmament and the security link; implementation and verification of nonproliferation regimes; transfer of technology and nuclear energy. The seminar culminated with a round table on confidence building

  6. Radioactive wastes. Management prospects. Appendixes

    International Nuclear Information System (INIS)

    Guillaumont, R.

    2003-01-01

    These appendixes complete the article BN3661 entitled 'Radioactive wastes. Management prospects'. They develop the principles of the different separation processes under study and make a status of the conditioning matrices that are envisaged: 1 - principles of advanced separation (separation of U, Np, Pu, Tc and I; separation of Am and Cm in two extraction steps (Diamex and Sanex processes); separation of Am and Cm in a single extraction step (Paladin process); separation of Am and Cm (Sesame process); separation of Cs (Calixarene process); 2 - principles of separation in pyro-chemistry: separation under inert atmosphere (non-oxidizing); separation in oxidizing conditions; 3 - conditioning matrices under study for separate elements: objectives and methodology, matrices for iodine, for cesium and for actinides. (J.S.)

  7. Prospective outcomes of injury study.

    Science.gov (United States)

    Derrett, S; Langley, J; Hokowhitu, B; Ameratunga, S; Hansen, P; Davie, G; Wyeth, E; Lilley, R

    2009-10-01

    In New Zealand (NZ), 20% of adults report a disability, of which one-third is caused by injury. No prospective epidemiological studies of predictors of disability following all-cause injury among New Zealanders have been undertaken. Internationally, studies have focused on a limited range of predictors or specific injuries. Although these studies provide useful insights, applicability to NZ is limited given the importance of NZ's unique macro-social factors, such as NZ's no-fault accident compensation and rehabilitation scheme, the Accident Compensation Corporation (ACC). (1) To quantitatively determine the injury, rehabilitation, personal, social and economic factors leading to disability outcomes following injury in NZ. (2) To qualitatively explore experiences and perceptions of injury-related outcomes in face-to-face interviews with 15 Māori and 15 other New Zealanders, 6 and 12 months after injury. Four geographical regions within NZ. Prospective cohort study with telephone interviews 1, 4 and 12 months after injury. 2500 people (including 460 Māori), aged 18-64 years, randomly selected from ACC's entitlement claims register (people likely to be off work for at least 1 week or equivalent). Telephone interviews, electronic hospital and ACC injury data. Exposures include demographic, social, economic, work-related, health status, participation and/or environmental factors. Primary: disability (including WHODAS II) and health-related quality of life (including EQ-5D). Secondary: participation (paid and unpaid activities), life satisfaction and costs. Separate regression models will be developed for each of the outcomes. Repeated measures outcomes will be modelled using general estimating equation models and generalised linear mixed models.

  8. Radiovirotherapy: principles and prospects in oncology.

    Science.gov (United States)

    Touchefeu, Y; Franken, P; Harrington, K J

    2012-01-01

    Radiovirotherapy is defined as the use of viruses to deliver radioisotopic treatment into infected cells. Oncolytic viruses are able to selectively target and kill cancer cells. The combination of oncolytic viruses and radiation therapies can have synergistic antitumour properties. Viruses may act as radiosensitizers, and radiations can increase viral oncolytic properties. The combination of oncolytic viruses with a virally-directed radioisotope therapy is an innovative method to combine viruses and radiation therapy, selectively within the tumour cells. The sodium/iodide symporter (NIS) is the main transgene that has been studied for this approach. NIS can mediate the uptake of isotopes of iodine and technetium 99m for in vivo gene expression imaging and therapy. This review highlights the principles of radiovirotherapy, and its recent progress. Better understanding of the regulation of NIS opens up pathways by which to potentiate the functional expression of NIS. In terms of the therapeutic isotope, Iodine-131 has been most frequently studied but other isotopes (astatine- 211, rhenium-188) are of growing interest. Oncolytic viruses are able to infect selectively and replicate in cancer cells and promising early phase clinical trials have been recently published. Their development allows a better selectivity of viral infection and adds a virus-specific cytotoxicity to the therapeutic approach. Active research into strategies such as immunosuppressive treatment and cell-based carrier systems is seeking to circumvent the host antiviral immune response and, thus, increase the potential for systemic delivery. Finally, other anticancer therapies such as chemotherapy and external beam radiotherapy may have a synergistic effect with radiovirotherapy and such combinatorial approaches offering the prospect of accelerated translation into clinical studies.

  9. Phase Field Approach

    Science.gov (United States)

    Koyama, Toshiyuki

    The term phase field has recently become known across many fields of materials science. The meaning of phase field is the spatial and temporal order parameter field defined in a continuum-diffused interface model. By using the phase field order parameters, many types of complex microstructure changes observed in materials science are described effectively. This methodology has been referred to as the phase field method, phase field simulation, phase field modeling, phase field approach, etc. In this chapter, the basic concept and theoretical background for the phase field approach is explained in Sects. 21.1 and 21.2. The overview of recent applications of the phase field method is demonstrated in Sects. 21.3 to 21.6.

  10. Iodine Status After Bariatric Surgery-a Prospective 10-Year Report from the Swedish Obese Subjects (SOS) Study.

    Science.gov (United States)

    Manousou, Sofia; Carlsson, Lena M S; Eggertsen, Robert; Hulthén, Lena; Jacobson, Peter; Landin-Wilhelmsen, Kerstin; Trimpou, Penelope; Svensson, Per-Arne; Nyström, Helena Filipsson

    2018-02-01

    Bariatric surgery can lead to nutrient deficiencies. Gastric by-pass (GBP) entails restriction and malabsorption, whereas, vertical banded gastroplasty (VBG) is only restrictive. The objective of this study is to study whether GBP-patients develop iodine deficiency from malabsorption, and if GBP- and VBG-patients develop lower 24-h urinary iodine excretion (24-UIE) than obese non-operated controls (OB-controls) due to lower iodine intake. The Swedish Obese Subjects (SOS) study is a prospective, non-randomized study of 4047 obese patients included 1987-2001, who chose bariatric surgery or non-surgical treatment. SOS-groups were compared at baseline, after 2 and 10 years and with population-based subsamples (MONICA-controls). One hundred eighty-eight GBP-patients were matched with 188 VBG-patients and 188 OB-controls and with three subgroups from 412 MONICA-controls. Primary outcome was 24-UIE. Secondary outcomes were iodine intake, iodine supplementation, TSH, FT4, and thyroid morbidity. At baseline, median 24-UIE was higher in GBP-patients, VBG-patients and OB-controls than in MONICA-controls (214, 201, 203 and 137 μg/day, p surgery, GBP- and VBG-patients did not suffer from iodine deficiency, but both groups had lower iodine status than OB-controls. Dietary supplements recommended after bariatric surgery do not need to include iodine, in iodine sufficient countries. clinicaltrials.gov : NCT01479452.

  11. Histologic Evidence of New Collagen Formulation Using Platelet Rich Plasma in Skin Rejuvenation: A Prospective Controlled Clinical Study.

    Science.gov (United States)

    Abuaf, Ozlem Karabudak; Yildiz, Hamza; Baloglu, Hüseyin; Bilgili, Memet Ersan; Simsek, Hasan Aktug; Dogan, Bilal

    2016-12-01

    Platelet-rich plasma (PRP) is an autologous concentration of human platelets contained in a small volume of plasma and has recently been shown to accelerate rejuvenate aging skin by various growth factors and cell adhesion molecules. This study was conducted to evaluate the efficacy and safety of intradermal injection of PRP in the human facial rejuvenation. This study was a prospective, single-center, single-dose, open-label, non-randomized controlled clinical study. PRP injected to the upper site of this right infra-auricular area and all face. Saline was injected to the left infra-auricular area. Histopathological examinations were performed before PRP treatment, 28 days after the PRP, and saline (control) treatments. Twenty women ranging in age from 40 to 49 years (mean age, 43.65±2.43 years) were enrolled in the study. The mean optical densities (MODs) of collagen in the pre-treatment, control, and PRP-treated area were measured. They were 539±93.2, 787±134.15, 1,019±178, respectively. In the MOD of PRP, 89.05 percent improvement was found when MOD of PRP was compared with MOD of pre-treatment. The mean MOD of collagen fibers was clearly highest on the PRP side ( p facial skin rejuvenation.

  12. Comparative effectiveness of medical and surgical therapy on olfaction in chronic rhinosinusitis: a prospective, multi-institutional study

    Science.gov (United States)

    DeConde, Adam S.; Mace, Jess C.; Alt, Jeremiah A.; Schlosser, Rodney J.; Smith, Timothy L.; Soler, Zachary M.

    2014-01-01

    Background Evidence comparing the impact of medical and surgical management of chronic rhinosinusitis on olfactory function is limited. This study evaluates olfactory outcomes in patients who failed initial medical management and elect either continued medical management or endoscopic sinus surgery (ESS) followed by medical management. Methods Adult subjects were prospectively enrolled into a non-randomized, multi-institutional cohort. Baseline characteristics, quality-of-life and objective clinical findings were collected along with two quality-of-life disease-specific measures, the Rhinosinusitis Disability Index (RSDI) and Sinonasal Outcome Test (SNOT-22). The primary outcome measure was the post-treatment change (≥6 months) in the Brief Smell Identification Test (B-SIT). Bivariate and multivariate analyses compared B-SIT changes by treatment type while controlling for baseline cofactors. Results Subjects (n=280) were enrolled between March, 2011 and May, 2013. Baseline B-SIT scores were comparable between medical and surgical treatment groups (8.8(3.2) vs 9.0(3.2); p=0.703). Subjects with baseline impaired olfaction (n=83; 29.6%) experienced mean B-SIT improvement in both the medical (n=17, 2.3(2.8), p=0.005) and surgical (n=66, 2.1(3.0), p0.050). Conclusion Subjects electing ESS experienced gains in olfaction comparable to subjects electing continued medical management. Further study with larger sample size and more sensitive measures of olfaction are needed to determine differences between treatment groups. PMID:25044658

  13. Association of cardiac development with assisted reproductive technology in childhood: a prospective single-blind pilot study.

    Science.gov (United States)

    Zhou, Jie; Liu, Hong; Gu, Hai-tao; Cui, Yu-gui; Zhao, Nan-nan; Chen, Juan; Gao, Li; Zhang, Yuan; Liu, Jia-yin

    2014-01-01

    To examine the pattern and extent of cardiovascular developmental alterations among children conceived by assisted reproductive technology (ART) and its association with potential confounders. The present study was a prospective single-blind pilot design lasting 15 months. The ART group was recruited by a non-random, consecutive sample on the basis of the unique personal identification number assigned to ART children, whereas spontaneous conception controls were recruited by a population-based random sample from the same hospital by age. Echocardiography was available for the measurement of 128 ART children and 100 controls with respect to cardiovascular geometric morphology and cardiac function. The majority of cardiac geometric morphology parameters were comparable among the study groups (P>0.05), except for significant increases in left ventricular (LV) relative wall thickness (P=0.038), LV mass index (P=0.005) and LV remodeling index (P=0.005) in ART children after adjustment for age, gender, body surface area and heart rate. The results showed similarity in LV systolic function characterized by ejection fraction (P=0.140) and shortening fraction (P=0.167) between the groups. However, ART children had a significant tendency toward a decrease in mitral A (P=0.008) and mitral E' (P=0.012) compared with controls after adjusting for confounders. Additionally, Cox analysis suggested an independent association (Pchildren compared with controls, which may be independently associated with the anthropometrics and perinatal outcomes in addition to the ART procedure. © 2014 S. Karger AG, Basel.

  14. Neurological outcome after emergency radiotherapy in MSCC of patients with non-small cell lung cancer - a prospective trial

    International Nuclear Information System (INIS)

    Rief, Harald; Heinhold, Rita C; Petersen, Lina C; Rieken, Stefan; Bruckner, Thomas; Moghaddam-Alvandi, Arash; Debus, Jürgen; Sterzing, Florian

    2013-01-01

    The aim of this trial was to investigate neurological outcome after emergency RT in MSCC of NSCLC patients with acute neurological deficit. This pilot trial was prospective, non-randomized, and monocentre, ten patients were treated from July 2012 until June 2013. After onset of neurological symptoms RT was started within 12 hours. The neurological outcome was assessed at baseline, and six weeks after RT using the ASIA Impairment Scale (AIS). The results showed an improved neurological outcome in one patient (10%), one patient (10%) had a decreased, and five patients (50%) a constant outcome after six weeks. Three patients (30%) died within the first six weeks following RT, additional 4 patients (40%) died within 4 month due to tumor progression. In this group of NSCLC patients we were able to show that emergency RT in MSCC with acute neurological deficit had no considerable benefit in neurological outcome. Therefore, short-course regime or best supportive care due to poor survival should be considered for these patients with additional distant metastases. Patients with favorable prognosis may be candidates for long-course RT

  15. Prospect theory and political decision-making

    NARCIS (Netherlands)

    Vis, B.

    2011-01-01

    Risk is a central feature of political decision making. Prospect theory, an empirically correct theory of choice under risk that deals precisely with this condition, therefore seems to have much to offer political science. Prospect theory's central finding is that individuals' attitude toward risk

  16. Nucleon decay experiments: status and prospects

    Energy Technology Data Exchange (ETDEWEB)

    Ayres, D.S.; Beier, E.W.; D' Ettorre Piazzoli, B.; Ernwein, J.; Gaisser, T.K.; Seidel, S.; Sulak, L.R.

    1986-01-01

    We survey the current status and future prospects of experiments to search for nucleon decay. Results from current experiments are summarized, and the background rejection capabilities of various techniques are described. We discuss the prospects for improved sensitivity in the new experiments that are now coming into operation, and the opportunities for the next generation of detectors. 33 refs., 2 figs., 4 tabs.

  17. Patterns of turnover and floristic similarity show a non-random distribution of naturalized flora in Chile, South America Patrones de recambio y similitud florística muestran una distribución no aleatoria de la flora naturalizada en Chile, Sudamérica

    Directory of Open Access Journals (Sweden)

    SERGIO A CASTRO

    2008-03-01

    Full Text Available The current geographical distribution of alien species could be informative of processes involved in the biological invasions facilitated by humans. Because environmental and anthropic factors affect the geographic distribution of alien plants, we hypothesize that naturalized plants have a non-random distribution along extensive geographical ranges. On the basis of a complete and updated database of naturalized plants in Chile, we analyzed their turnover and floristic similarities among regions that encompass a wide latitudinal gradient in South America. Using Moran's index and Mantel's test we characterized the spatial auto-correlation (regional aggregation and the effect of geographical distance on the index values. Additionally, we used clustering methods and resampling procedures to detect plant assemblages at regional level. Whittaker's index displayed a positive tilt, increasing according to geographical distance and reaching a plateau; conversely, Jaccard's index was negatively associated with geographical distance. Removing the effect of distance, both Whittaker's and Jaccard's values showed no significant trends. Multivariate analysis combined with resampling procedures revealed the existence of three distinctive plant clusters: Northernmost Chile, Central-southern Chile, and Southernmost Chile. These clusters are characterized by naturalized plants that are not present in the others. Based on this evidence, we conclude that the set of naturalized plants in Chile exhibits a non-random geographical distribution, displaying an ordered geographical pattern across regions (latitude. We discuss the role of the environmental variables (climate, latitude and land use post-European colonization as factors in the distributional patterns here documentedLa distribución geográfica actual de especies exóticas puede ser informativa de los procesos involucrados en las invasiones biológicas facilitadas por humanos. Debido a que los factores

  18. Status and development of uranium prospection methods

    International Nuclear Information System (INIS)

    Barthel, F.

    1978-01-01

    In radiometric prospection, gamma measuring equipment is widely used. Simple instruments, so-called scintillometers, can only measure total radiation while spectrometers permit separate measurements of uranium, thorium, or calcium via daughter products of their decay chains. Depending on the target investigated, airborne, carborne, or footborne methods are employed. In radon prospection the gaseous decay product radon is measured as a sign of hidden uranium enrichment in ground air or water from springs. Due to its high solubility, uranium is well suited for geochemical prospection where uranium concentrations in bodies of water, river sediments, soil and rock types are determined. There is a trend in uranium prospection towards the discovery of hidden orifications. Novel techniques, e.g. airborne geochemistry, isotope chemistry, tracer element measurement, etc. are being tested with a view to their suitability for uranium prospection. (orig./HP) 891 HP/orig.- 892 MKO [de

  19. Phase Coexistence in a Dynamic Phase Diagram.

    Science.gov (United States)

    Gentile, Luigi; Coppola, Luigi; Balog, Sandor; Mortensen, Kell; Ranieri, Giuseppe A; Olsson, Ulf

    2015-08-03

    Metastability and phase coexistence are important concepts in colloidal science. Typically, the phase diagram of colloidal systems is considered at the equilibrium without the presence of an external field. However, several studies have reported phase transition under mechanical deformation. The reason behind phase coexistence under shear flow is not fully understood. Here, multilamellar vesicle (MLV)-to-sponge (L3 ) and MLV-to-Lα transitions upon increasing temperature are detected using flow small-angle neutron scattering techniques. Coexistence of Lα and MLV phases at 40 °C under shear flow is detected by using flow NMR spectroscopy. The unusual rheological behavior observed by studying the lamellar phase of a non-ionic surfactant is explained using (2) H NMR and diffusion flow NMR spectroscopy with the coexistence of planar lamellar-multilamellar vesicles. Moreover, a dynamic phase diagram over a wide range of temperatures is proposed. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  20. Prospective dose selection and acceleration of paliperidone palmitate 3‐month formulation development using a pharmacometric bridging strategy

    Science.gov (United States)

    Nandy, Partha; Ravenstijn, Paulien; Remmerie, Bart; Vermeulen, An; Russu, Alberto; D'hoore, Peter; Baum, Ellen Z.; Savitz, Adam; Gopal, Srihari; Hough, David

    2016-01-01

    Aims To prospectively select the dose of the paliperidone palmitate 3‐month (PP3M) formulation, using a pharmacometric bridging strategy based on the paliperidone palmitate 1‐month (PP1M) formulation previously approved for schizophrenia treatment. Methods Pharmacokinetic (PK) data from a 6‐month interim analysis of a single dose PP3M Phase I clinical trial was integrated with a previously developed PP1M population‐PK model. The model was updated to incorporate formulation as a covariate on absorption parameters and to explore the most critical design element of the Phase III study: the PP1M‐to‐PP3M dose multiplier for patients switching formulations. Plasma paliperidone concentrations were measured at predetermined intervals during Phase III, enabling comparison of the multiple‐dose PK between PP1M and PP3M. Exposure matching was assessed graphically to determine whether paliperidone plasma concentrations from the two formulations overlapped. Results Prospective steady‐state PK simulations revealed that a 3.5 multiple of the PP1M dose would yield a corresponding PP3M dose with comparable exposure. The prospective pharmacometric simulation and observed Phase III PK data agreed closely. Phase III results confirmed the hypothesis that efficacy of PP3M was noninferior to that of PP1M. The similarity in exposures between the two formulations was likely a key determinant of the equivalent efficacy between the two products observed in the Phase III study. Conclusions Successful prospective PP3M Phase III clinical trial dose selection was achieved through the use of pharmacometric bridging, without conducting a Phase II study and using only limited Phase I data for PP3M. We estimate that this strategy reduced development time by 3–5 years and may be applicable to other drug development projects. PMID:27333588

  1. High temperature phase equilibria and phase diagrams

    CERN Document Server

    Kuo, Chu-Kun; Yan, Dong-Sheng

    2013-01-01

    High temperature phase equilibria studies play an increasingly important role in materials science and engineering. It is especially significant in the research into the properties of the material and the ways in which they can be improved. This is achieved by observing equilibrium and by examining the phase relationships at high temperature. The study of high temperature phase diagrams of nonmetallic systems began in the early 1900s when silica and mineral systems containing silica were focussed upon. Since then technical ceramics emerged and more emphasis has been placed on high temperature

  2. Digital quadrature phase detection

    Science.gov (United States)

    Smith, J.A.; Johnson, J.A.

    1992-05-26

    A system for detecting the phase of a frequency or phase modulated signal that includes digital quadrature sampling of the frequency or phase modulated signal at two times that are one quarter of a cycle of a reference signal apart, determination of the arctangent of the ratio of a first sampling of the frequency or phase modulated signal to the second sampling of the frequency or phase modulated signal, and a determination of quadrant in which the phase determination is increased by 2[pi] when the quadrant changes from the first quadrant to the fourth quadrant and decreased by 2[pi] when the quadrant changes from the fourth quadrant to the first quadrant whereby the absolute phase of the frequency or phase modulated signal can be determined using an arbitrary reference convention. 6 figs.

  3. Therapy Provider Phase Information

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Therapy Provider Phase Information dataset is a tool for providers to search by their National Provider Identifier (NPI) number to determine their phase for...

  4. Thermodynamic modeling of phase equilibria of semi-clathrate hydrates of CO2, CH4, or N2+tetra-n-butylammonium bromide aqueous solution

    DEFF Research Database (Denmark)

    Eslamimanesh, Ali; Mohammadi, Amir H.; Richon, Dominique

    2012-01-01

    ) aqueous solution. For modeling the hydrate phase, the van der Waals–Platteeuw (vdW–P) solid solution theory is used, revised with two modifications for evaluations of Langmuir constants and vapor pressure of water in the empty hydrate lattice, in which these values are supposed to be a function of TBAB......, the Non-Random Two-Liquid (NRTL) activity model is used. To calculate the mean activity coefficients of the electrolyte portion, a correlation on the basis of existing osmotic coefficient and activity coefficient values is employed. It is shown that the presented model results are in acceptable agreement...

  5. Antiaging therapy: a prospective hypothesis

    Directory of Open Access Journals (Sweden)

    Shahidi Bonjar MR

    2015-01-01

    Full Text Available Mohammad Rashid Shahidi Bonjar,1 Leyla Shahidi Bonjar2 1School of Dentistry, Kerman University of Medical Sciences, Kerman Iran; 2Department of Pharmacology, College of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran Abstract: This hypothesis proposes a new prospective approach to slow the aging process in older humans. The hypothesis could lead to developing new treatments for age-related illnesses and help humans to live longer. This hypothesis has no previous documentation in scientific media and has no protocol. Scientists have presented evidence that systemic aging is influenced by peculiar molecules in the blood. Researchers at Albert Einstein College of Medicine, New York, and Harvard University in Cambridge discovered elevated titer of aging-related molecules (ARMs in blood, which trigger cascade of aging process in mice; they also indicated that the process can be reduced or even reversed. By inhibiting the production of ARMs, they could reduce age-related cognitive and physical declines. The present hypothesis offers a new approach to translate these findings into medical treatment: extracorporeal adjustment of ARMs would lead to slower rates of aging. A prospective “antiaging blood filtration column” (AABFC is a nanotechnological device that would fulfill the central role in this approach. An AABFC would set a near-youth homeostatic titer of ARMs in the blood. In this regard, the AABFC immobilizes ARMs from the blood while blood passes through the column. The AABFC harbors antibodies against ARMs. ARM antibodies would be conjugated irreversibly to ARMs on contact surfaces of the reaction platforms inside the AABFC till near-youth homeostasis is attained. The treatment is performed with the aid of a blood-circulating pump. Similar to a renal dialysis machine, blood would circulate from the body to the AABFC and from there back to the body in a closed circuit until ARMs were sufficiently depleted from the blood. The

  6. Prospects for European labour demand.

    Science.gov (United States)

    Lindley, R M

    1988-07-01

    The impact of economic and technological trends upon the level and structure of labor demand is examined, exploring the methods used to model the labor market and making special reference to demography and technology. Evidence on recent and prospective changes in labor demand is reviewed for France, Germany, Italy, the Netherlands, and the UK. The models used to explore future employment scenarios usually fail to incorporate the linkages required to fully analyze the various demographic-economic interactions. Further, this is not generally viewed as a limitation, given the time frame of most employment projections and their preoccupation with changes in the structure of labor demand. Medium-term multisectoral models tend to pay more attention to both demographic and technical change, but the treatment of both aspects is limited. The projections provide a framework for considering how both socioeconomic behavior and policy might change to achieve different outcomes. The greater a model's behavioral content, as expressed in its relationships between different variables, the greater the insight obtainable from simulation exercises. The 1st half of the 1970s was characterized by a reduction in German employment, representing the severest of European reactions to the oil crisis. The 2nd half of the decade recorded rapid growth in Italy and the Netherlands. The 1980s started with marked declines in Germany and the UK. Overall, the net gains of the 1970s were lost in the recession following the 2nd oil crisis. In none of the 5 countries studied does any realistic prospect emerge of achieving full employment before 2000. The most optimistic outcome is that unemployment will decline only slowly, it at all. The growth of both new forms and areas of employment will not compensate sufficiently for the loss of jobs elsewhere and the growth of labor supply. The industrial sector will continue to experience change in favor of the service sector but at a slower rate than during

  7. Gas phase ion chemistry

    CERN Document Server

    Bowers, Michael T

    1979-01-01

    Gas Phase Ion Chemistry, Volume 2 covers the advances in gas phase ion chemistry. The book discusses the stabilities of positive ions from equilibrium gas-phase basicity measurements; the experimental methods used to determine molecular electron affinities, specifically photoelectron spectroscopy, photodetachment spectroscopy, charge transfer, and collisional ionization; and the gas-phase acidity scale. The text also describes the basis of the technique of chemical ionization mass spectrometry; the energetics and mechanisms of unimolecular reactions of positive ions; and the photodissociation

  8. Phased-array radars

    Science.gov (United States)

    Brookner, E.

    1985-02-01

    The operating principles, technology, and applications of phased-array radars are reviewed and illustrated with diagrams and photographs. Consideration is given to the antenna elements, circuitry for time delays, phase shifters, pulse coding and compression, and hybrid radars combining phased arrays with lenses to alter the beam characteristics. The capabilities and typical hardware of phased arrays are shown using the US military systems COBRA DANE and PAVE PAWS as examples.

  9. Is determination between complete and incomplete traumatic spinal cord injury clinically relevant? Validation of the ASIA sacral sparing criteria in a prospective cohort of 432 patients.

    NARCIS (Netherlands)

    Middendorp, J.J. van; Hosman, A.J.F.; Pouw, M.H.; Meent, H. van de

    2009-01-01

    STUDY DESIGN: Prospective multicenter longitudinal cohort study. OBJECTIVE: To validate the prognostic value of the acute phase sacral sparing measurements with regard to chronic phase-independent ambulation in patients with traumatic spinal cord injury (SCI). SETTING: European Multicenter Study of

  10. Phase Reconfigurable Nulling Interferometer, Phase I

    Data.gov (United States)

    National Aeronautics and Space Administration — We propose the use of a phase reconfigurable spatial light modulator (SLM) in place of a static computer generated hologram (CGH) in interferometric test systems for...

  11. Computation of Phase Equilibrium and Phase Envelopes

    DEFF Research Database (Denmark)

    Ritschel, Tobias Kasper Skovborg; Jørgensen, John Bagterp

    In this technical report, we describe the computation of phase equilibrium and phase envelopes based on expressions for the fugacity coefficients. We derive those expressions from the residual Gibbs energy. We consider 1) ideal gases and liquids modeled with correlations from the DIPPR database...... and 2) nonideal gases and liquids modeled with cubic equations of state. Next, we derive the equilibrium conditions for an isothermal-isobaric (constant temperature, constant pressure) vapor-liquid equilibrium process (PT flash), and we present a method for the computation of phase envelopes. We...... formulate the involved equations in terms of the fugacity coefficients. We present expressions for the first-order derivatives. Such derivatives are necessary in computationally efficient gradient-based methods for solving the vapor-liquid equilibrium equations and for computing phase envelopes. Finally, we...

  12. Omega phase in materials

    International Nuclear Information System (INIS)

    Sikka, S.K.; Vohra, Y.K.; Chidambaram, R.

    1982-01-01

    The subject is covered in sections, entitled: introduction; occurrence and some systematics of omega phase (omega phase in Ti, Zr and Hf under high pressures; omega phase in Group IV transition metal alloys; omega in other systems; omega embryos at high temperatures); crystallography (omega structure; relationship of ω-structure to bcc (β) and hcp (α) structures); physical properties; kinetics of formation, synthesis and metastability of omega phase (kinetics of α-ω transformation under high pressures; kinetics of β-ω transformation; synthesis and metastability studies); electronic structure of omega phase (electronic structure models; band structure calculations; theoretical results and experimental studies); electronic basis for omega phase stability (unified phase diagram; stability of omega phase); omega phase formation under combined thermal and pressure treatment in alloys (Ti-V alloys under pressure - a prototype case study; P-X phase diagrams for alloys; transformation mechanisms and models for diffuse omega phase (is omega structure a charge density distortion of the bcc phase; nature of incommensurate ω-structure and models for diffuse scattering); conclusion. (U.K.)

  13. Geochemical methodology for gold prospect ion in Uruguay

    International Nuclear Information System (INIS)

    Spangenber, J.

    1987-01-01

    This work is about the history of gold prospection in Uruguay. In this study there are considered the geochemical aspects, the gold performance, the applicability to mining prospection and the gold prospection aluvionar

  14. Gel phase formation in dilute triblock copolyelectrolyte complexes

    Energy Technology Data Exchange (ETDEWEB)

    Srivastava, Samanvaya; Andreev, Marat; Levi, Adam E.; Goldfeld, David J.; Mao, Jun; Heller, William T.; Prabhu, Vivek M.; de Pablo, Juan J.; Tirrell, Matthew V.

    2017-02-23

    Assembly of oppositely charged triblock copolyelectrolytes into phase-separated gels at low polymer concentrations (<1% by mass) has been observed in scattering experiments and molecular dynamics simulations. Here we show that in contrast to uncharged, amphiphilic block copolymers that form discrete micelles at low concentrations and enter a phase of strongly interacting micelles in a gradual manner with increasing concentration, the formation of a dilute phase of individual micelles is prevented in polyelectrolyte complexation-driven assembly of triblock copolyelectrolytes. Gel phases form and phase separate almost instantaneously on solvation of the copolymers. Furthermore, molecular models of self-assembly demonstrate the presence of oligo-chain aggregates in early stages of copolyelectrolyte assembly, at experimentally unobservable polymer concentrations. Our discoveries contribute to the fundamental understanding of the structure and pathways of complexation-driven assemblies, and raise intriguing prospects for gel formation at extraordinarily low concentrations, with applications in tissue engineering, agriculture, water purification and theranostics.

  15. Acute phase reaction and acute phase proteins*

    Science.gov (United States)

    Gruys, E.; Toussaint, M.J.M.; Niewold, T.A.; Koopmans, S.J.

    2005-01-01

    A review of the systemic acute phase reaction with major cytokines involved, and the hepatic metabolic changes, negative and positive acute phase proteins (APPs) with function and associated pathology is given. It appears that APPs represent appropriate analytes for assessment of animal health. Whereas they represent non-specific markers as biological effect reactants, they can be used for assessing nutritional deficits and reactive processes, especially when positive and negative acute phase variables are combined in an index. When such acute phase index is applied to separate healthy animals from animals with some disease, much better results are obtained than with single analytes and statistically acceptable results for culling individual animals may be reached. Unfortunately at present no cheap, comprehensive and easy to use system is available for assessing various acute phase proteins in serum or blood samples at the same time. Protein microarray or fluid phase microchip technology may satisfy this need; and permit simultaneous analysis of numerous analytes in the same small volume sample and enable integration of information derived from systemic reactivity and nutrition with disease specific variables. Applying such technology may help to solve health problems in various countries not only in animal husbandry but also in human populations. PMID:16252337

  16. Differential Phase Detector for Precise Phase Alignment

    CERN Document Server

    Olexa, Jakub

    2016-01-01

    This paper presents a differential phase detector circuit, whose phase-to-voltage characteristic has an extremum when its two input signals are exactly in phase. In this condition all its digital signals are of 50 % duty cycle so that the circuit characteristic does not have a dead zone. This feature allows a precise indication of the zero-phase condition, which is independent of the detector power supply and the offset of its ADC readout. Such a detector is used for a phase alignment of two reference clock signals with frequency about 11 kHz in front-ends processing signals from beam position monitors of the Large Hadron Collider (LHC) at CERN. The detector output voltage is digitized with a 24-bit ADC at the rate of the reference signals. The resulting samples are processed in the front-end FPGA and transmitted to the control system using an Ethernet data stream. After a detailed description of the differential phase detector its performance is demonstrated with laboratory measurements. The results show tha...

  17. Prospects of geothermal resource exploitation

    International Nuclear Information System (INIS)

    Bourrelier, P.H.; Cornet, F.; Fouillac, C.

    1994-01-01

    The use of geothermal energy to generate electricity has only occurred during the past 50 years by drilling wells in aquifers close to magmas and producing either dry steam or hot water. The world's production of electricity from geothermal energy is over 6000 MWe and is still growing. The direct use of geothermal energy for major urban communities has been developed recently by exploitation of aquifers in sedimentary basins under large towns. Scaling up the extraction of heat implies the exploitation of larger and better located fields requiring an appropriate method of extraction; the objective of present attempts in USA, Japan and Europe is to create heat exchangers by the circulation of water between several deep wells. Two field categories are considered: the extension of classical geothermal fields beyond the aquifer areas, and areas favoured by both a high geothermal gradient, fractures inducing a natural permeability at large scale, and good commercial prospects (such as in the Rhenan Graben). Hot dry rocks concept has gained a large interest. 1 fig., 5 tabs., 11 refs

  18. Experimental prospects of hadron colliders

    International Nuclear Information System (INIS)

    Iwasaki, Hiroyuki

    1984-01-01

    The main subject of this report is to take a general view on the experiment with several tens of TeV hadron colliders. Intensive studies have been carried out about the physics and the detectors for such hadron machines. The experimental prospect of hadron colliders based on the studies and the view of the author are presented. To obtain a fundamental knowledge on the experiment with hadron colliders, the general properties of hadron scattering should be investigated. First, the total cross sections and charged particle multiplicity are estimated, and hard scattering process is reviewed. The cross sections for some interesting hard scattering process are summarized. The most serious problem for the experiment with hadron colliders is to pick out useful signals from enormous QCD back-ground processes, and a possibility of finding heavy Higgs bosons is discussed in detail as an example. On the basis of these studies, the requirement which general purpose detectors should satisfy is considered. Also the important machine parameters from experimental viewpoint are discussed. High energy hadron colliders have a potentiality to reveal new physics in TeV region, but the preparation for unexpected physics is necessary. (Kako, I.)

  19. Prospects of Single Tax Payers

    Directory of Open Access Journals (Sweden)

    Tofan Ivan M.

    2014-03-01

    Full Text Available The article speaks about problem aspects of taxation, which were set by the state for the single tax administering due to permanent and system changes in the tax legislation. It shows the necessity of search for alternative methods of administering in the process of taxation of single tax payers by fiscal services. The goal of the article is the study of prospects of further taxation of entrepreneurs – single tax payers on the basis of analysis of conditions and principles created by the state for the business. The article used methods of system analysis, comparison, forecasting and modelling. It analyses the process of evolution of the simplified taxation system, accounting and reporting from the moment of its adoption until today. The article presents the structure of the quantitative composition of single tax payers depending on the selected groups. It marks out and characterises administrative and fiscal factors that do not facilitate further development of entrepreneurship in Ukraine. In the result of the conducted studies the article outlines problem aspects of organisation of taxation of the small business and offers specific and real ways of their overcoming or partial solution.

  20. Robert Galisson : histoire et prospective

    Directory of Open Access Journals (Sweden)

    Clara Ferrão Tavares

    2016-12-01

    Full Text Available Je dois le titre de cet article à Christian Puren qui, dans le numéro des ELA 123-124, qu’il a coordonné, en hommage à Robert Galisson, disait « (si je devais pour ma part retenir un mot, un seul, pour caractériser ce qui me paraît constituer la structure profonde de la pensée et de l’action de Robert Galisson, je ne retiendrais que ce mot de deux lettres, l’opérateur logique ET, que l’on utilise pour relier entre eux deux éléments en même temps qu’on en reconnaît paradoxalement la différence : chercheur ET généraliste, théorie ET pratique, langue ET culture, histoire ET prospective » (Puren, 2001 : 263-264. J’aurais pu, d’ailleurs, choisir les autres « couplages », notamment les couplages enseignant Et didacticien ou raison ET affectivité.

  1. Soap production: A green prospective.

    Science.gov (United States)

    Félix, Sandra; Araújo, Joana; Pires, Ana Maria; Sousa, Ana Cláudia

    2017-08-01

    A green prospective based on the reuse of waste materials such as almond shells, orange peel and used cooking oil to manufacture soap is presented. In Portugal, thousands of tons of waste are generated from used cooking oil and production of nut shells' residues is growing every year. In addition, the high consumption of citrus fruits, oranges in particular, generates large amounts of citrus peel. Therefore, it is necessary to diversify reuse mechanisms of these wastes, in order to make them back into raw materials. Complying with this trend, this work was carried out by processing and grinding almond shells, treating used oil, processing orange peels and extracting limonene, formulating and producing soap, and performing an acceptance study of the final product. Results validated a high potential of the idea in the field of environmental education, so it can be replicated in practical classes. It can also be useful for waste management, and it can support the development of community projects on an ecological approach. Copyright © 2017 Elsevier Ltd. All rights reserved.

  2. Status and prospects for reprocessing

    International Nuclear Information System (INIS)

    Rossney, G.K.

    1977-01-01

    Following the formation of United Reprocessors (U.R.G.) in 1976 by British Nuclear Fuels Limited (B.N.F.L.) in the United Kingdom, the Commissariat a l'Energie Atomique (C.E.A.) in France and K.E.W.A. Kernbrennstoff-Wiederaufarbeitungs-Gesellschaft MBH (K.E.W.A.) in Germany, collaboration is now well established for the marketing of their reprocessing services for irradiated oxide fuel from thermal reactors. In addition collaboration in the continued evolution of the technology has progressed and an extensive research and development programme has been established, the results of which are exchanged between the shareholders. During 1976 the U.K. Government has given approval to B.N.F.L. to sign further contracts with foreign customers, subject to certain conditions. In France, the fuel cycle activities of the C.E.A. have been vested in a new company (Compagnie Generale Des Matieres Nucleaires (C.O.G.E.M.A.)) and their La Hague plant has commenced reprocessing operations on irradiated oxide fuel. In Germany, an agreement has been signed between K.E.W.A. and P.W.K. for the pre-project study for the proposed German plant. Against this background this paper reviews the present status of reprocessing by the shareholders of U.R.G. and the prospects for reprocessing

  3. Accelerating dual cardiac phase images using undersampled radial phase encoding trajectories.

    Science.gov (United States)

    Letelier, Karis; Urbina, Jesus; Andía, Marcelo; Tejos, Cristián; Irarrazaval, Pablo; Prieto, Claudia; Uribe, Sergio

    2016-09-01

    A three-dimensional dual-cardiac-phase (3D-DCP) scan has been proposed to acquire two data sets of the whole heart and great vessels during the end-diastolic and end-systolic cardiac phases in a single free-breathing scan. This method has shown accurate assessment of cardiac anatomy and function but is limited by long acquisition times. This work proposes to accelerate the acquisition and reconstruction of 3D-DCP scans by exploiting redundant information of the outer k-space regions of both cardiac phases. This is achieved using a modified radial-phase-encoding trajectory and gridding reconstruction with uniform coil combination. The end-diastolic acquisition trajectory was angularly shifted with respect to the end-systolic phase. Initially, a fully-sampled 3D-DCP scan was acquired to determine the optimal percentage of the outer k-space data that can be combined between cardiac phases. Thereafter, prospectively undersampled data were reconstructed based on this percentage. As gold standard images, the undersampled data were also reconstructed using iterative SENSE. To validate the method, image quality assessments and a cardiac volume analysis were performed. The proposed method was tested in thirteen healthy volunteers (mean age, 30years). Prospectively undersampled data (R=4) reconstructed with 50% combination led high quality images. There were no significant differences in the image quality and in the cardiac volume analysis between our method and iterative SENSE. In addition, the proposed approach reduced the reconstruction time from 40min to 1min. In conclusion, the proposed method obtains 3D-DCP scans with an image quality comparable to those reconstructed with iterative SENSE, and within a clinically acceptable reconstruction time. Copyright © 2016 Elsevier Inc. All rights reserved.

  4. Application of phase-change materials in memory taxonomy.

    Science.gov (United States)

    Wang, Lei; Tu, Liang; Wen, Jing

    2017-01-01

    Phase-change materials are suitable for data storage because they exhibit reversible transitions between crystalline and amorphous states that have distinguishable electrical and optical properties. Consequently, these materials find applications in diverse memory devices ranging from conventional optical discs to emerging nanophotonic devices. Current research efforts are mostly devoted to phase-change random access memory, whereas the applications of phase-change materials in other types of memory devices are rarely reported. Here we review the physical principles of phase-change materials and devices aiming to help researchers understand the concept of phase-change memory. We classify phase-change memory devices into phase-change optical disc, phase-change scanning probe memory, phase-change random access memory, and phase-change nanophotonic device, according to their locations in memory hierarchy. For each device type we discuss the physical principles in conjunction with merits and weakness for data storage applications. We also outline state-of-the-art technologies and future prospects.

  5. PROSPECT Background Studies and Operation of Li-Loaded Liquid Scintillator Detectors at a Research Reactor

    Science.gov (United States)

    Langford, Thomas; Prospect Collaboration

    2015-04-01

    Segmented antineutrino detectors placed near compact research reactors provide an excellent opportunity to probe short-baseline neutrino oscillations and precisely measure the reactor antineutrino spectrum. PROSPECT is a phased experiment that will explore the favored reactor anomaly parameter space at the High Flux Isotope Reactor (HFIR) at Oak Ridge National Lab. Measurements of the reactor correlated and ambient backgrounds will be presented, as well as a discussion of active and passive mitigation plans. A lithium-loaded liquid scintillator test detector is currently in operation at HFIR within a prototype shielding cave. Results from recent operation will be presented along with a discussion of their impact on PROSPECT. on behalf of the PROSPECT collaboration.

  6. Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

    Science.gov (United States)

    Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

    2017-01-01

    Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015). All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Quality of reporting was assessed using the Key Methodological Score. 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles.

  7. Commission errors in delay-execute prospective memory tasks.

    Science.gov (United States)

    Schaper, Philipp; Grundgeiger, Tobias

    2017-08-01

    Individuals frequently retrieve an intention, but the execution of the task needs to be delayed due to ongoing task demands - so-called delay-execute prospective memory (PM) tasks. We investigated commission errors in the delay-execute paradigm. Participants were told that a PM task is finished (PM task has been executed and is now finished for a final phase) or cancelled (PM task has been cancelled immediately after introduction). We observed commission errors and ongoing task performance in the final phase which included several irrelevant PM cues. In two experiments, we observed significantly more commission errors for cancelled compared to the finished intentions. In Experiment 2, commission errors were eliminated if the final phase required divided attention, regardless of PM task status. In addition, we observed significantly more PM cue interference on the ongoing task in the cancelled compared to the finished group, indicating that the PM task was retrieved in the cancelled group but not in the finished group. As retrieval and execution of the PM task were separated by a delay, the results indicate that commission errors are not always the result of a quick, spontaneous retrieval-execution sequence and may also occur when retrieval and execution are temporally separated.

  8. Generalized Phase Contrast

    CERN Document Server

    Glückstad, Jesper

    2009-01-01

    Generalized Phase Contrast elevates the phase contrast technique not only to improve phase imaging but also to cross over and interface with diverse and seemingly disparate fields of contemporary optics and photonics. This book presents a comprehensive introduction to the Generalized Phase Contrast (GPC) method including an overview of the range of current and potential applications of GPC in wavefront sensing and phase imaging, structured laser illumination and image projection, optical trapping and manipulation, and optical encryption and decryption. The GPC method goes further than the restrictive assumptions of conventional Zernike phase contrast analysis and achieves an expanded range of validity beyond weak phase perturbations. The generalized analysis yields design criteria for tuning experimental parameters to achieve optimal performance in terms of accuracy, fidelity and light efficiency. Optimization can address practical issues, such as finding an optimal spatial filter for the chosen application, ...

  9. Solid phase radioimmunoassays

    International Nuclear Information System (INIS)

    Wide, L.

    1977-01-01

    Solid phase coupled antibodies were introduced to facilitate the separation of bound and free labelled ligand in the competitive inhibition radioimmunoassay. Originally, the solid matrix used was in the form of small particles and since then a number of different matrices have been used such as very fine powder particles, gels, paper and plastic discs, magnetic particles and the inside surface of plastic tubes. The coupling of antibodies may be that of a covalent chemical binding, a strong physical adsorbtion, or an immunological binding to a solid phase coupled antigen. New principles of radioimmunoassay such as the solid phase sandwich techniques and the immunoradiometric assay were developped from the use of solid phase coupled antigens and antibodies. The solid phase sandwich techniques are reagent excess methods with a very wide applicability. Several of the different variants of solid phase techniques are suitable for automation. Advantages and disadvantages of solid phase radioimmunoassays when compared with those using soluble reagents are discussed. (orig.) [de

  10. Generalized phase contrast:

    DEFF Research Database (Denmark)

    Glückstad, Jesper; Palima, Darwin

    (GPC) method including an overview of the range of current and potential applications of GPC in wavefront sensing and phase imaging, structured laser illumination and image projection, optical trapping and manipulation, and optical encryption and decryption. The GPC method goes further than......Generalized Phase Contrast elevates the phase contrast technique not only to improve phase imaging but also to cross over and interface with diverse and seemingly disparate fields of contemporary optics and photonics. This book presents a comprehensive introduction to the Generalized Phase Contrast...... efficiency. Optimization can address practical issues, such as finding an optimal spatial filter for the chosen application, and can even enable a Reverse Phase Contrast mode where intensity patterns are converted into a phase modulation....

  11. Quantum phase transitions

    International Nuclear Information System (INIS)

    Sachdev, S.

    1999-01-01

    Phase transitions are normally associated with changes of temperature but a new type of transition - caused by quantum fluctuations near absolute zero - is possible, and can tell us more about the properties of a wide range of systems in condensed-matter physics. Nature abounds with phase transitions. The boiling and freezing of water are everyday examples of phase transitions, as are more exotic processes such as superconductivity and superfluidity. The universe itself is thought to have passed through several phase transitions as the high-temperature plasma formed by the big bang cooled to form the world as we know it today. Phase transitions are traditionally classified as first or second order. In first-order transitions the two phases co-exist at the transition temperature - e.g. ice and water at 0 deg., or water and steam at 100 deg. In second-order transitions the two phases do not co-exist. In the last decade, attention has focused on phase transitions that are qualitatively different from the examples noted above: these are quantum phase transitions and they occur only at the absolute zero of temperature. The transition takes place at the ''quantum critical'' value of some other parameter such as pressure, composition or magnetic field strength. A quantum phase transition takes place when co-operative ordering of the system disappears, but this loss of order is driven solely by the quantum fluctuations demanded by Heisenberg's uncertainty principle. The physical properties of these quantum fluctuations are quite distinct from those of the thermal fluctuations responsible for traditional, finite-temperature phase transitions. In particular, the quantum system is described by a complex-valued wavefunction, and the dynamics of its phase near the quantum critical point requires novel theories that have no analogue in the traditional framework of phase transitions. In this article the author describes the history of quantum phase transitions. (UK)

  12. Jojoba: an assessment of prospects

    Energy Technology Data Exchange (ETDEWEB)

    Walters, P.R.; MacFarlane, W.; Spensley, P.C.

    1979-01-01

    Jojoba (Simmondsia chinensis) is a crop that might be cultivated profitably in the arid and semi-arid zones of certain cultivated profitably in the arid and semi-arid zones of certain developing countries. This report assesses the present state of research on the crop and gives an opinion as to its prospects of being of economic benefit to these areas. The report is divided into five sections. In Section 1 the plant and its natural habitats are described and current research and the problems to be overcome in cultivating the crop are outlined. In Section 2 the chemistry of jojoba and other waxes is discussed. In Section 3 consideration is given to the end-use potential of jojoba and an attempt is made to forecast the future market demand and price for jojoba oil, both as a liquid and as a solid wax. In Section 4 the economics of jojoba production are discussed in light of the findings in the earlier sections. Finally, in Section 5, the wider aspects of plant introductions are considered briefly and conclusions drawn regarding jojoba's potential and its future research needs. It will be essential to increase jojoba yield significantly before cultivation will be viable except on a small scale. A satisfactory mechanized harvesting system also needs to be developed. The market for jojoba oil at various levels of production is estimated at production of less than 1000 tons (pounds-sterling 5500- pounds-sterling 7700 per ton); production of 2000 to 5000 tons (pounds-sterling 900- pounds-sterling 950 per ton); and production up to 20,000 tons (pounds-sterling 500-pounds-sterling 600 per ton).

  13. Energy intensities: Prospects and potential

    International Nuclear Information System (INIS)

    Anon.

    1992-01-01

    In the previous chapter, the author described how rising activity levels and structural change are pushing toward higher energy use in many sectors and regions, especially in the developing countries. The extent to which more activity leads to greater energy use will depend on the energy intensity of end-use activities. In this chapter, the author presents an overview of the potential for intensity reductions in each sector over the next 10-20 years. It is not the author's intent to describe in detail the various technologies that could be employed to improve energy efficiency, which has been done by others (see, for example, Lovins ampersand Lovins, 1991; Goldembert et al., 1987). Rather, he discusses the key factors that will shape future energy intensities in different parts of the world, and gives a sense for the changes that could be attained if greater attention were given to accelerate efficiency improvement. The prospects for energy intensities, and the potential for reduction, vary among sectors and parts of the world. In the majority of cases, intensities are tending to decline as new equipment and facilities come into use and improvements are made on existing stocks. The effect of stock turnover will be especially strong in the developing countries, where stocks are growing at a rapid pace, and the Former East Bloc, where much of the existing industrial plant will eventually be retired and replaced with more modern facilities. While reductions in energy intensity are likely in most areas, there is a large divergence between the technical and economic potential for reducing energy intensities and the direction in which present trends are moving. In the next chapter, the author presents scenarios that illustrate where trends are pointing, and what could be achieved if improving energy efficiency were a focus of public policies. 53 refs., 4 figs., 2 tabs

  14. Prospective Coding by Spiking Neurons.

    Directory of Open Access Journals (Sweden)

    Johanni Brea

    2016-06-01

    Full Text Available Animals learn to make predictions, such as associating the sound of a bell with upcoming feeding or predicting a movement that a motor command is eliciting. How predictions are realized on the neuronal level and what plasticity rule underlies their learning is not well understood. Here we propose a biologically plausible synaptic plasticity rule to learn predictions on a single neuron level on a timescale of seconds. The learning rule allows a spiking two-compartment neuron to match its current firing rate to its own expected future discounted firing rate. For instance, if an originally neutral event is repeatedly followed by an event that elevates the firing rate of a neuron, the originally neutral event will eventually also elevate the neuron's firing rate. The plasticity rule is a form of spike timing dependent plasticity in which a presynaptic spike followed by a postsynaptic spike leads to potentiation. Even if the plasticity window has a width of 20 milliseconds, associations on the time scale of seconds can be learned. We illustrate prospective coding with three examples: learning to predict a time varying input, learning to predict the next stimulus in a delayed paired-associate task and learning with a recurrent network to reproduce a temporally compressed version of a sequence. We discuss the potential role of the learning mechanism in classical trace conditioning. In the special case that the signal to be predicted encodes reward, the neuron learns to predict the discounted future reward and learning is closely related to the temporal difference learning algorithm TD(λ.

  15. [Acute bronchiolitis: a prospective study].

    Science.gov (United States)

    Mação, Patrícia; Dias, Andrea; Azevedo, Lúcia; Jorge, Arminda; Rodrigues, Carlos

    2011-12-01

    Bronchiolitis is the most common lower respiratory infection in children under 2 years old. Respiratory syncytial virus (RSV) is the most frequently involved etiologic agent. To identify different viruses causing bronchiolitis and try to correlate them with demographic and clinical variables. To analyze diagnostic and therapeutic approache. We conducted a prospective study, between November 2008 and March 2009 (5 months), including children bronchiolitis. Screening for RSV, parainfluenza 1-3 and adenovirus used immunofluorescence tests and screening for influenza A and B, human metapneumovirus (MPvh), human bocavirus (hBoV) and RSV used polymerase chain reaction (PCR) techniques. Data were analysed by using SPSS®. We included 78 children with 8.5 months mean age (83% physiotherapy. Viral testing was positive in 59/75 children: RSV (69.3%), BoVh (22.7%), MPVh (4%), parainfluenza 3 (27%) and influenza A (2.6%). Co-infection with two viruses was detected in 23% of children. In 88% of children with positive samples for BoVh it has been detected RSV infection simultaneously. Children with co-infection (RSV + BoVh) required more often hospitalization compared with children infected with RSV alone (80% vs 60%, p=0.028), without significant differences in oxygen supplementation need and length of disease. RSV was the main etiologic agent and oxygen supplementation requirement justified the majority of hospitalizations. There was a high rate of co-infection with RSV and BoVh, but without longer disease. BoVh infection alone was uncommon.

  16. Cosmic Humanity: Utopia, Realities, Prospects

    Directory of Open Access Journals (Sweden)

    Sergey Krichevsky

    2017-07-01

    Full Text Available The philosophical foundations of the theory and practice of the creation of cosmic humanity as a process of the evolution of human civilization, the emergence into space, with the prospect of resettlement outside the Earth are considered. There is a connection between myths, fantasies, ideas, concepts and projects aimed at the exploration of outer space, the creation of cosmic humanity. A new and voluminous definition of cosmic humanity in the evolutionary paradigm is given. Cosmic humanity is (essence and 4 stages of evolution: 1. Humanity living on Earth, sensing, knowing, understanding its cosmic origin, relationship with the cosmos and cosmic destiny. 2. Humanity living on Earth, leading aerospace activity for the purposes of exploration and use of aerospace space (Heaven, Space for survival and development. 3. Humanity living on Earth and outside the Earth — in the solar system, preserving the Earth and mastering the Cosmos for survival and development. 4. Humanity, settled and living in the Cosmos. Now humanity is in the process of transition from the second to the third stage. In the process of this evolution, a complex transformation of man and society takes place. The problem-semantic field of cosmic humanity is described and its general model is presented. The meta-goal-setting is the justification of cosmic humanity with the application of the anthropic principle and its “active” super (post anthropic supplement: “Cosmic humanity has an evolutionary purpose to actively manage evolution: change man, humanity and the universe.” The evolution of the “cosmic dream”, goals and technologies of space activities is formalized in the form of a conceptual model. Challenges and negative trends are considered in connection with the crisis of space activity, criticism and attempts to limit the flights of people into space. The prototype of cosmic humanity, its basis and acting model is the cosmonauts’ community. The main

  17. Electrophysiological evidence during episodic prospection implicates medial prefrontal and bilateral middle temporal gyrus.

    Science.gov (United States)

    Hsu, Chia-Fen; Sonuga-Barke, Edmund J S

    2016-08-01

    fMRI studies have implicated the medial prefrontal cortex and medial temporal lobe, components of the default mode network (DMN), in episodic prospection. This study compared quantitative EEG localized to these DMN regions during prospection and during resting and while waiting for rewards. EEG was recorded in twenty-two adults while they were asked to (i) envision future monetary episodes; (ii) wait for rewards and (iii) rest. Activation sources were localized to core DMN regions. EEG power and phase coherence were compared across conditions. Prospection, compared to resting and waiting, was associated with reduced power in the medial prefrontal gyrus and increased power in the bilateral medial temporal gyrus across frequency bands as well as greater phase synchrony between these regions in the delta band. The current quantitative EEG analysis confirms prior fMRI research suggesting that medial prefrontal and medial temporal gyrus interactions are central to the capacity for episodic prospection. Copyright © 2016 Elsevier B.V. All rights reserved.

  18. Prospective teachers information and communication technology metaphors

    Directory of Open Access Journals (Sweden)

    Ömür Akdemir

    2015-04-01

    Full Text Available Determination of the perceptions of the prospective teachers for the Information and Communications Technology (ICT terms have a remarkable potential to provide input for technology integration plans and ICT trainings. Within this context, the purpose of this study is to discover the metaphors constructed by prospective teachers for the ICT terms. Data were gathered from 180 prospective teachers through survey. 977 valid metaphors constructed by the participants were grouped into conceptual categories for the six ICT terms. The most common conceptual categories are “developing and changing” for technology, “making life easy” for computers and search engines, “limitless and endless” for the Internet, “means of communication” for social networks, and “addictive items” for video games. Future research should concentrate on investigating the match and mismatches between intended use of the ICT tools and the perception of the prospective teachers.

  19. Effects of sleep deprivation on prospective memory.

    Science.gov (United States)

    Grundgeiger, Tobias; Bayen, Ute J; Horn, Sebastian S

    2014-01-01

    Sleep deprivation reduces cognitive performance; however, its effects on prospective memory (remembering to perform intended actions) are unknown. One view suggests that effects of sleep deprivation are limited to tasks associated with prefrontal functioning. An alternative view suggests a global, unspecific effect on human cognition, which should affect a variety of cognitive tasks. We investigated the impact of sleep deprivation (25 hours of sleep deprivation vs. no sleep deprivation) on prospective-memory performance in more resource-demanding and less resource-demanding prospective-memory tasks. Performance was lower after sleep deprivation and with a more resource-demanding prospective-memory task, but these factors did not interact. These results support the view that sleep deprivation affects cognition more globally and demonstrate that sleep deprivation increases failures to carry out intended actions, which may have severe consequences in safety-critical situations.

  20. Complex prospective memory in children with ADHD.

    Science.gov (United States)

    Kliegel, Matthias; Ropeter, Anna; Mackinlay, Rachael

    2006-12-01

    The ability to remember intentions (prospective memory) is fundamental to the organization of goal-directed actions in everyday life. Successful prospective remembering involves forming, retaining, initiating, and executing an intention. Although previous research has demonstrated prospective memory impairments in children with attention deficit/hyperactivity disorder (ADHD), this has largely focused on the intention initiation and execution stages. In this study, we investigate the performance of 20 children with ADHD and 20 matched controls at each of the four stages of prospective memory, using a computer multitask paradigm. Results suggest that children with ADHD may demonstrate difficulties forming delayed intentions, as indicated by impulsive planning, and that this may have further implications for the retention and implementation of these delayed intentions. While children with ADHD showed comparable multitask switching, this appeared to be at the expense of intention execution as they made more performance errors than controls. Implications for day-to-day functioning are discussed.

  1. Overview of the uranium prospecting in Uruguay

    International Nuclear Information System (INIS)

    Rossi, P; Vaz Chaves, N.; Pirelli, H.

    1985-01-01

    The report is about Uranium prospection in Uruguay by DINAMIGE experts. They were explained the radioactive properties elements in Uranium and its importance as a fuel oil for electric energy generation

  2. Hospital Outpatient Prospective Payment System (OPPS) Lim...

    Data.gov (United States)

    U.S. Department of Health & Human Services — Hospital Outpatient Prospective Payment System (OPPS) Limited Data Set This file contains select claim level data and is derived from 2010 hospital outpatient PPS...

  3. Physics prospects at a linear -collider

    Indian Academy of Sciences (India)

    The talk described the prospects of studying standard model parameters as well as scenarios beyond the standard model, like the minimal supersymmetric standard model, theories with extra dimensions and theories with extra neutral gauge bosons, at a future linear + - collider.

  4. Nuclear radiation cleanup and uranium prospecting

    Science.gov (United States)

    Mariella, Jr., Raymond P.; Dardenne, Yves M.

    2016-02-02

    Apparatus, systems, and methods for nuclear radiation cleanup and uranium prospecting include the steps of identifying an area; collecting samples; sample preparation; identification, assay, and analysis; and relating the samples to the area.

  5. Caolines Program. N1 area prospective soundings

    International Nuclear Information System (INIS)

    Coronel, N.; Mari, C.

    1984-01-01

    This work is about The Caolines program. After several stages was designed a network of drilling to be developed in prospective areas. The support of this network was a geological cartography performed in a devonian region.

  6. A prospective international Aspergillus terreus survey

    DEFF Research Database (Denmark)

    Risslegger, B; Zoran, T; Lackner, M

    2017-01-01

    OBJECTIVES: A prospective international multicentre surveillance study was conducted to investigate the prevalence and amphotericin B susceptibility of Aspergillus terreus species complex infections. METHODS: A total of 370 cases from 21 countries were evaluated. RESULTS: The overall prevalence o...

  7. Technical development of seismic imaging prospecting

    International Nuclear Information System (INIS)

    Xu Guilai

    2006-01-01

    Geophysical methods and apparatus for shallow engineering geophysical prospecting and mining related in-roadway geophysical prospecting are important research fields which has been studied for long time, unfortunately, little significant advancement has been made compared with the demand of engineering geology. The seismic imaging method and its corresponding equipment are viewed as the most hopeful choice for 0-50 m depth and are studied in this research systematically. The recording equipment CSA is made and the related in-situ data processing software is also developed. Field application experiment for shallow seismic prospecting has been finished, the results show that the CSA seismic imaging and its application technology are effective and practical for the engineering geophysical prospecting of 0-50 m depth, and can meet the demand of engineering geology investigation. Hence, the geophysical method and equipment, which can meet the demand for 0-50 m depth engineering geology investigation have been formed through this research. (authors)

  8. Current status and prospects for Chernobyl Ukritiye

    International Nuclear Information System (INIS)

    Jampsin, B.

    1996-01-01

    Current status and prospects for Chernobyl Ukritiye (sarcophagus) are described, including the following issues: the accident; the sarcophagus; the radioactive inventory; the design basis criteria; the analysis of the present state; a way forward

  9. Essence and prospects of internet banking

    OpenAIRE

    Popova I.; Fesenko Ya.

    2017-01-01

    The paper discussed the current state and prospects of development of internet banking. The aim of the article is to define the “Internet banking” concept of the disclosure of its essence, the study of the current state and prospects of development. The advantages and disadvantages of the system. In the following general research methods were used: analysis, to reveal the concept of “Internet Banking” analyzes the main advantages and disadvantages, comparison, generalization. A number of ...

  10. Training course on radiometric prospecting techniques

    International Nuclear Information System (INIS)

    1979-01-01

    A training course on radiometric prospecting techniques was presented by the Atomic Energy Board in collaboration with the South African Geophysical Association and the Geological Society of South Africa. Various aspects related to uranium prospecting were discussed e.g. the uranium supply and demand position, the basic physics of radioactivity, uranium geochemistry, mineralogy and mobility, the instrumentation and techniques used in uranium exploration, for example, borehole logging, radon emanometry and airborne radiometric surveys and also data processing and interpretation methods

  11. Uranium prospection methods illustrated with examples

    International Nuclear Information System (INIS)

    Valsardieu, C.

    1985-01-01

    Uranium exploration methods are briefly reviewed: aerial (radiometric, spectrometric), surface (mapping, radiometric, geophysical, geochemical), sub-surface (well logging, boring) and mining methods in the different steps of a mine project: preliminary studies, general prospecting, detailed prospecting deposit area and deposit estimation. Choice of methods depends strongly on geographic and geologic environment. Three examples are given concerning: an intragranitic deposit Limousin (France), a deposit spatially related to a discordance Athabasca (Canada) and a sedimentary deposit Manyingee (Western Australia) [fr

  12. Anisotropy effects during dwell-fatigue caused by δ-phase orientation in forged Inconel 718

    International Nuclear Information System (INIS)

    Saarimäki, Jonas; Colliander, Magnus Hörnqvist; Moverare, Johan J.

    2017-01-01

    Inconel 718 is a commonly used superalloy for turbine discs in the gas turbine industry. Turbine discs are often subjected to dwell-fatigue as a result of long constant load cycles. The effect of anisotropy on dwell-fatigue cracking in forged turbine discs have not yet been thoroughly investigated. Crack propagation behaviour was characterised using compact tension (CT) samples cut in different orientations from a real turbine disc forging. Samples were also cut in two different thicknesses in order to investigate the influence of plane strain and plane stress condition on the crack propagation rates. The samples were subjected to dwell-fatigue tests at 550 °C with 90 s or 2160 s dwell-times at maximum load. Microstructure characterisation was done using scanning electron microscopy (SEM) techniques such as electron channelling contrast imaging (ECCI), electron backscatter diffraction (EBSD), and light optical microscopy (LOM). The forged alloy exhibits strong anisotropic behaviour caused by the non-random δ-phase orientation. When δ-phases were oriented perpendicular compared to parallel to the loading direction, the crack growth rates were approximately ten times faster. Crack growth occurred preferably in the interface between the γ-matrix and the δ-phase.

  13. Evaluation of Thermodynamic Models for Predicting Phase Equilibria of CO2 + Impurity Binary Mixture

    Science.gov (United States)

    Shin, Byeong Soo; Rho, Won Gu; You, Seong-Sik; Kang, Jeong Won; Lee, Chul Soo

    2018-03-01

    For the design and operation of CO2 capture and storage (CCS) processes, equation of state (EoS) models are used for phase equilibrium calculations. Reliability of an EoS model plays a crucial role, and many variations of EoS models have been reported and continue to be published. The prediction of phase equilibria for CO2 mixtures containing SO2, N2, NO, H2, O2, CH4, H2S, Ar, and H2O is important for CO2 transportation because the captured gas normally contains small amounts of impurities even though it is purified in advance. For the design of pipelines in deep sea or arctic conditions, flow assurance and safety are considered priority issues, and highly reliable calculations are required. In this work, predictive Soave-Redlich-Kwong, cubic plus association, Groupe Européen de Recherches Gazières (GERG-2008), perturbed-chain statistical associating fluid theory, and non-random lattice fluids hydrogen bond EoS models were compared regarding performance in calculating phase equilibria of CO2-impurity binary mixtures and with the collected literature data. No single EoS could cover the entire range of systems considered in this study. Weaknesses and strong points of each EoS model were analyzed, and recommendations are given as guidelines for safe design and operation of CCS processes.

  14. Nanotechnology in agriculture: prospects and constraints

    Directory of Open Access Journals (Sweden)

    Mukhopadhyay SS

    2014-08-01

    Full Text Available Siddhartha S Mukhopadhyay Electron Microscopy and Nanoscience Laboratory, Punjab Agricultural University, Ludhiana, India Abstract: Attempts to apply nanotechnology in agriculture began with the growing realization that conventional farming technologies would neither be able to increase productivity any further nor restore ecosystems damaged by existing technologies back to their pristine state; in particular because the long-term effects of farming with “miracle seeds”, in conjunction with irrigation, fertilizers, and pesticides, have been questioned both at the scientific and policy levels, and must be gradually phased out. Nanotechnology in agriculture has gained momentum in the last decade with an abundance of public funding, but the pace of development is modest, even though many disciplines come under the umbrella of agriculture. This could be attributed to: a unique nature of farm production, which functions as an open system whereby energy and matter are exchanged freely; the scale of demand of input materials always being gigantic in contrast with industrial nanoproducts; an absence of control over the input nanomaterials in contrast with industrial nanoproducts (eg, the cell phone and because their fate has to be conceived on the geosphere (pedosphere-biosphere-hydrosphere-atmosphere continuum; the time lag of emerging technologies reaching the farmers' field, especially given that many emerging economies are unwilling to spend on innovation; and the lack of foresight resulting from agricultural education not having attracted a sufficient number of brilliant minds the world over, while personnel from kindred disciplines might lack an understanding of agricultural production systems. If these issues are taken care of, nanotechnologic intervention in farming has bright prospects for improving the efficiency of nutrient use through nanoformulations of fertilizers, breaking yield barriers through bionanotechnology, surveillance and

  15. Nanotechnology in agriculture: prospects and constraints.

    Science.gov (United States)

    Mukhopadhyay, Siddhartha S

    2014-01-01

    Attempts to apply nanotechnology in agriculture began with the growing realization that conventional farming technologies would neither be able to increase productivity any further nor restore ecosystems damaged by existing technologies back to their pristine state; in particular because the long-term effects of farming with "miracle seeds", in conjunction with irrigation, fertilizers, and pesticides, have been questioned both at the scientific and policy levels, and must be gradually phased out. Nanotechnology in agriculture has gained momentum in the last decade with an abundance of public funding, but the pace of development is modest, even though many disciplines come under the umbrella of agriculture. This could be attributed to: a unique nature of farm production, which functions as an open system whereby energy and matter are exchanged freely; the scale of demand of input materials always being gigantic in contrast with industrial nanoproducts; an absence of control over the input nanomaterials in contrast with industrial nanoproducts (eg, the cell phone) and because their fate has to be conceived on the geosphere (pedosphere)-biosphere-hydrosphere-atmosphere continuum; the time lag of emerging technologies reaching the farmers' field, especially given that many emerging economies are unwilling to spend on innovation; and the lack of foresight resulting from agricultural education not having attracted a sufficient number of brilliant minds the world over, while personnel from kindred disciplines might lack an understanding of agricultural production systems. If these issues are taken care of, nanotechnologic intervention in farming has bright prospects for improving the efficiency of nutrient use through nanoformulations of fertilizers, breaking yield barriers through bionanotechnology, surveillance and control of pests and diseases, understanding mechanisms of host-parasite interactions at the molecular level, development of new-generation pesticides and

  16. MOTIVATIONAL AND ADAPTATIVE ASPECT OF PROSPECTIVE MUSIC TEACHERS’ VOCAL TRAINING

    Directory of Open Access Journals (Sweden)

    Lin Ye

    2016-04-01

    Full Text Available The article deals with motivational and adaptive direction of vocal training of the Art Faculty students of the Pedagogical University. Motivational and adaptive phase consisted in identifying the real state of prospective music teachers’ readiness to work with educational vocal choirs. The criterion of formation of motivational and adaptive component is defined as personal motivation in acquiring high-quality vocal and choral training. The author developed an experimental technique that involves a number of empirical research methods: special and long-term monitoring of the content and progress of the educational process; analysis, control and objectivity of teaching methods; testing; perform creative tasks; test activities; conversations and interviews that were conducted among students, faculty and trainers professional disciplines teaching practice.The mentioned criterion implies that Chinese students have sustained professional focus on improving their own vocal and choral training, awareness of the importance and prospects of this profession in their practical activities in educational conditions in China. Motivation in learning vocal and choral activities, Chinese students made the so-called "immunity" to the difficulties related with the new learning environment in universities Ukraine increases the desire to intensify and optimize the process of conducting and choral training, there is awareness of the need for new development knowledge, skills, new experience and carry it into practice national music and teacher education.

  17. Physics prospects for the SLAC B-Factory

    Energy Technology Data Exchange (ETDEWEB)

    Coward, D.H.

    1996-11-01

    CP violation has been an enigma since its discovery in the decays of neutral kaons in 1964. The present version of the Standard Model can accommodate CP violation by means of a non-zero phase in the Cabibbo-Kobayashi-Maskawa (CKM) matrix. However, CP violation in the kaon system occurs at the part per mille level and the Standard Model`s predictions for CP violation have not been conclusively tested. In contrast to the kaon system, B-mesons decay into a variety of final states, many of which could exhibit CP violation and therefore offer multiple tests of the Standard Model. Several large efforts currently are in progress to create dedicated experiments or factories which will provide large quantities of B-mesons which, in turn, should give large numbers of CP-violating decays. Here, a very brief presentation of the physics prospects for the SLAC B-Factory, now under construction, is presented.

  18. Experiential Learning Model in Enhancing Prospective English Teachers` Teaching Competence

    Directory of Open Access Journals (Sweden)

    Heri Mudra

    2017-09-01

    Full Text Available This study aimed to describe the effectiveness of Experiential Learning (EL model in improving prospective EFL teachers’ (PETs teaching competence. The method of this study was Classroom Action Research (CAR consisting of planning, observing, acting, and reflecting phases. There were two cycles needed in implementing EL to the twenty one EFL learners as the participants. The results revealed that each subcompetence in cycle I and cycle II was achieved in the following score: planning & preparation for learning (Mean in cycle I=2,8; Mean in cycle II=3,38, classroom management (Mean in cycle I=2,5; Mean in cycle II=2,95, delivery of instruction (Mean in cycle I=2,6; Mean in cycle II=2,90, and monitoring, assessment, and follow-up (Mean in cycle I=2,4; Mean in cycle II=2,95. It can be concluded that EL is effective in improving PETs’ teaching competence.

  19. Prospects for Detecting Thermal Emission from Terrestrial Exoplanets with JWST

    Science.gov (United States)

    Kreidberg, Laura

    2018-01-01

    A plethora of nearby, terrestrial exoplanets has been discovered recently by ground-based surveys. Excitingly, some of these are in the habitable zones of their host stars, and may be hospitable for life. However, all the planets orbit small, cool stars and have considerably different irradiation environments from the Earth, making them vulnerable to atmospheric escape, erosion and collapse. Atmosphere characterization is therefore critical to assessing the planets' habitability. I will discuss possible JWST thermal emission measurements to determine the atmospheric properties of nearby terrestrial planets. I will focus on prospects for detecting physically motivated atmospheres for planets orbiting LHS 1140, GJ 1132, and TRAPPIST-1. I will also discuss the potential for using phase curve observations to determine whether an atmosphere has survived on the non-transiting planet Proxima b.

  20. Age differences in multiple outcome measures of time-based prospective memory.

    Science.gov (United States)

    Mäntylä, Timo; Missier, Fabio Del; Nilsson, Lars-Göran

    2009-11-01

    This study examined time-based prospective memory performance in relation to age, monitoring strategy, response accuracy, and dual-task demands. Young, middle-aged and older adults (N = 115) completed a prospective memory task, in which they indicated the passing of time every 5 min while listening to a short story (low task demands) or completing a series of cognitive tasks (high task demands). Young and older adults showed similar patterns of monitoring behavior, with low rates of clock checking during the early phase of each 5-min interval, followed by linearly accelerating monitoring functions. However, to obtain the same level of prospective memory performance older adults needed more frequent clock checks than young adults. Furthermore, older adults' compensatory monitoring strategy was associated with an additional cost in primary task performance. Finally, increased primary task demands shifted age differences in prospective memory from monitoring frequency to response accuracy. These findings suggest that goal-directed behavior requires efficient task coordination and resource allocation, and that age-related differences in time-based prospective memory should be evaluated by using multiple outcome measures.

  1. Prospective areas of the Valle Rio Santa Lucia sanstones (preliminar study)

    International Nuclear Information System (INIS)

    Coronel, N.; Spoturno, J.; Theune, C.

    1980-01-01

    This work was presented, in the second phase of sands prospecting for construction program.This project have been as purpose, to assure the supply of Montevideo with this long term material. The study was carried out in framework of the project of Geologic Collaboration Uruguayan-German. A detail cartography was made in an area of 435 km2 in the low course of the River Santa Lucia (from 20 to 50 km West of Montevideo).

  2. Prospecting for marine gas hydrate resources

    Science.gov (United States)

    Boswell, Ray; Shipp, Craig; Reichel, Thomas; Shelander, Dianna; Saeki, Tetsuo; Frye, Matthew; Shedd, William; Collett, Timothy S.; McConnell, Daniel R.

    2016-01-01

    As gas hydrate energy assessment matures worldwide, emphasis has evolved away from confirmation of the mere presence of gas hydrate to the more complex issue of prospecting for those specific accumulations that are viable resource targets. Gas hydrate exploration now integrates the unique pressure and temperature preconditions for gas hydrate occurrence with those concepts and practices that are the basis for conventional oil and gas exploration. We have aimed to assimilate the lessons learned to date in global gas hydrate exploration to outline a generalized prospecting approach as follows: (1) use existing well and geophysical data to delineate the gas hydrate stability zone (GHSZ), (2) identify and evaluate potential direct indications of hydrate occurrence through evaluation of interval of elevated acoustic velocity and/or seismic events of prospective amplitude and polarity, (3) mitigate geologic risk via regional seismic and stratigraphic facies analysis as well as seismic mapping of amplitude distribution along prospective horizons, and (4) mitigate further prospect risk through assessment of the evidence of gas presence and migration into the GHSZ. Although a wide range of occurrence types might ultimately become viable energy supply options, this approach, which has been tested in only a small number of locations worldwide, has directed prospect evaluation toward those sand-hosted, high-saturation occurrences that were presently considered to have the greatest future commercial potential.

  3. Prospect Theory for Online Financial Trading

    Science.gov (United States)

    Liu, Yang-Yu; Nacher, Jose C.; Ochiai, Tomoshiro; Martino, Mauro; Altshuler, Yaniv

    2014-03-01

    Prospect theory is widely viewed as the best available descriptive model of how people evaluate risk in experimental settings. According to prospect theory, people make decisions based on the potential value of losses and gains rather than the final outcome. People are risk-averse with respect to gains and risk-seeking with respect to losses, a phenomenon called ``loss aversion''. Despite of the fact that prospect theory has been well studied in behavioral economics at the theoretical level, there exist very few empirical research and most of them has been undertaken with micro-panel data. Here we analyze the trading activities of over 1.5 million members of an online financial trading community over 28 months, aiming to explore the large-scale empirical aspect of prospect theory. By analyzing and comparing the behaviour of ``winners'' and ``losers'', i.e., traders with positive or negative final net profit, we find clear evidence of the loss aversion phenomenon, an essence in prospect theory. This work demonstrates an unprecedented large-scale empirical evidence of prospect theory. It has immediate implication in financial trading, e.g., developing new trading strategies by minimizing the effect of loss aversion. It also provides opportunity to augment online social trading, where users are allowed to watch and follow the trading activity of others, by predicting potential winners based on their historical trading behaviour.

  4. Development of the PROSPECT Source Calibration System

    Science.gov (United States)

    Bykadorova, Arina; Prospect Collaboration

    2016-09-01

    PROSPECT, the Precision Reactor Oscillation and Spectrum Experiment, is a short-baseline antineutrino experiment consisting of a movable liquid scintillator detector operated near Oak Ridge National Laboratory's High Flux Isotope Reactor (HFIR). PROSPECT is designed to make a precise measurement of the antineutrino spectrum emitted from 235U fissions in a highly-enriched uranium reactor core, and to probe for eV-scale sterile neutrinos by examining neutrino oscillations at a distance of 7-12 m from the reactor. These measurements will address the observed reactor anomalies: the deficit in the reactor flux and the deviation in the spectral shape. PROSPECT consists of a 2-ton segmented liquid scintillator detector. Each segment is read out with two photomultipliers. Energy response and position reconstruction are calibrated using radioactive gamma and neutron sources. We have developed a retractable source deployment system that allows the placement of sources along the length of the detector segments and tested it using PROSPECT-50, a 50-liter detector prototype consisting of two segments. We will present the design of the PROSPECT source calibration system and results from PROSPECT-50. Wright Laboratory, Department of Physics, Yale University, New Haven, CT, USA.

  5. Diffusionless phase transformations

    International Nuclear Information System (INIS)

    Vejman, K.M.

    1987-01-01

    Diffusionless phase transformations in metals and alloys in the process of which atomic displacements occur at the distances lower than interatomic ones and relative correspondence of neighbour atoms is preserved, are considered. Special attention is paid to the mechanism of martensitic transformations. Phenomenologic crystallographical theory of martensitic transformations are presented. Two types of martensitic transformations different from the energy viewpoint are pointed out - thermoelastic and non-thermoelastic ones - which are characterized by transformation hysteresis and ways of martensite - initial phase reverse transformation realization. Mechanical effect in the martensitic transformations have been analyzed. The problem of diffusionless formation of ω-phases and the effect of impurities and vacancies on the process are briefly discussed. The role of charge density waves in phase transformations of the second type (transition of initial phase into noncommensurate one) and of the first type (transition of noncommensurate phase into commensurate one) is considered

  6. Phosphatidylcholine: cholesterol phase diagrams.

    Science.gov (United States)

    Thewalt, J L; Bloom, M

    1992-10-01

    Two mono-cis-unsaturated phosphatidylcholine (PC) lipid molecules, having very different gel-liquid crystalline phase transition temperatures as a consequence of the relative positions of the double bond, exhibit PC:cholesterol phase diagrams that are very similar to each other and to that obtained previously for a fully saturated PC:cholesterol mixture (Vist, M. R., and J. H. Davis. 1990. Biochemistry 29:451-464). This leads to the conjecture that PC:cholesterol membrane phase diagrams have a universal form which is relatively independent of the precise chemical structure of the PC molecule. One feature of this phase diagram is the observation over a wide temperature range of a fluid but highly conformationally ordered phase at bilayer concentrations of more than approximately 25 mol% cholesterol. This ;liquid ordered' phase is postulated to be the relevant physical state for many biological membranes, such as the plasma membrane of eukaryotic cells, that contain substantial amounts of cholesterol or equivalent sterols.

  7. Gymnastics in Phase Space

    Energy Technology Data Exchange (ETDEWEB)

    Chao, Alexander Wu; /SLAC

    2012-03-01

    As accelerator technology advances, the requirements on accelerator beam quality become increasingly demanding. Facing these new demands, the topic of phase space gymnastics is becoming a new focus of accelerator physics R&D. In a phase space gymnastics, the beam's phase space distribution is manipulated and precision tailored to meet the required beam qualities. On the other hand, all realization of such gymnastics will have to obey accelerator physics principles as well as technological limitations. Recent examples of phase space gymnastics include Emittance exchanges, Phase space exchanges, Emittance partitioning, Seeded FELs and Microbunched beams. The emittance related topics of this list are reviewed in this report. The accelerator physics basis, the optics design principles that provide these phase space manipulations, and the possible applications of these gymnastics, are discussed. This fascinating new field promises to be a powerful tool of the future.

  8. Single-Phase PLLs

    DEFF Research Database (Denmark)

    Golestan, Saeed; Guerrero, Josep M.; Quintero, Juan Carlos Vasquez

    2017-01-01

    Single-phase phase-locked loops (PLLs) are popular for the synchronization and control of single-phase gridconnected converters. They are also widely used for monitoring and diagnostic purposes in the power and energy areas. In recent years, a large number of single-phase PLLs with different...... structures and properties have been proposed in the literature. The main aim of this paper is to provide a review of these PLLs. To this end, the single-phase PLLs are first classified into two major categories: 1) power-based PLLs (pPLLs), and 2) quadrature signal generation-based PLLs (QSG......-PLLs). The members of each category are then described and their pros and cons are discussed. This work provides a deep insight into characteristics of different single-phase PLLs and, therefore, can be considered as a reference for researchers and engineers....

  9. Neurocognitive systems related to real-world prospective memory.

    Directory of Open Access Journals (Sweden)

    Grégoria Kalpouzos

    Full Text Available BACKGROUND: Prospective memory (PM denotes the ability to remember to perform actions in the future. It has been argued that standard laboratory paradigms fail to capture core aspects of PM. METHODOLOGY/PRINCIPAL FINDINGS: We combined functional MRI, virtual reality, eye-tracking and verbal reports to explore the dynamic allocation of neurocognitive processes during a naturalistic PM task where individuals performed errands in a realistic model of their residential town. Based on eye movement data and verbal reports, we modeled PM as an iterative loop of five sustained and transient phases: intention maintenance before target detection (TD, TD, intention maintenance after TD, action, and switching, the latter representing the activation of a new intention in mind. The fMRI analyses revealed continuous engagement of a top-down fronto-parietal network throughout the entire task, likely subserving goal maintenance in mind. In addition, a shift was observed from a perceptual (occipital system while searching for places to go, to a mnemonic (temporo-parietal, fronto-hippocampal system for remembering what actions to perform after TD. Updating of the top-down fronto-parietal network occurred at both TD and switching, the latter likely also being characterized by frontopolar activity. CONCLUSION/SIGNIFICANCE: Taken together, these findings show how brain systems complementary interact during real-world PM, and support a more complete model of PM that can be applied to naturalistic PM tasks and that we named PROspective MEmory DYnamic (PROMEDY model because of its dynamics on both multi-phase iteration and the interactions of distinct neurocognitive networks.

  10. Prospectivity Modeling of Karstic Groundwater Using a Sequential Exploration Approach in Tepal Area, Iran

    Science.gov (United States)

    Sharifi, Fereydoun; Arab-Amiri, Ali Reza; Kamkar-Rouhani, Abolghasem; Yousefi, Mahyar; Davoodabadi-Farahani, Meysam

    2017-09-01

    The purpose of this study is water prospectivity modeling (WPM) for recognizing karstic water-bearing zones by using analyses of geo-exploration data in Kal-Qorno valley, located in Tepal area, north of Iran. For this, a sequential exploration method applied on geo-evidential data to delineate target areas for further exploration. In this regard, two major exploration phases including regional and local scales were performed. In the first phase, indicator geological features, structures and lithological units, were used to model groundwater prospectivity as a regional scale. In this phase, for karstic WPM, fuzzy lithological and structural evidence layers were generated and combined using fuzzy operators. After generating target areas using WPM, in the second phase geophysical surveys including gravimetry and geoelectrical resistivity were carried out on the recognized high potential zones as a local scale exploration. Finally the results of geophysical analyses in the second phase were used to select suitable drilling locations to access and extract karstic groundwater in the study area.

  11. A prospective treatment for sepsis

    Directory of Open Access Journals (Sweden)

    Shahidi Bonjar MR

    2015-05-01

    Full Text Available Mohammad Rashid Shahidi Bonjar,1 Leyla Shahidi Bonjar2 1School of Dentistry, 2College of Pharmacy, Kerman University of Medical Sciences, Kerman, Iran Abstract: The present paper proposes a prospective auxiliary treatment for sepsis. There exists no record in the published media on the subject. As an auxiliary therapy, efficacious extracorporeal removal of sepsis-causing bacterial antigens and their toxins (BATs from the blood of septic patients is discussed. The principal component to this approach is a bacterial polyvalent antibody-column (BPVAC, which selectively traps wide spectrum of BATs from blood in an extracorporeal circuit, and detoxified blood returns back to the patient’s body. BPVAC treatment would be a device of targeted medicine. Detoxification is performed under supervision of trained personnel using simple blood-circulating machines in which blood circulates from the patient to BPVAC and back to the patient aseptically. BPVACs’ reactive sites consist of carbon nanotubes on which a vast spectra of polyvalent BATs-antibodies are bond to. The devise acts as a biological filter that selectively immobilizes harmful BATs from intoxicated blood; however, no dialysis is involved. For effective neutralization, BPVAC provides large contact surface area with blood. BPVAC approach would have advantages of: 1 urgent neutralization of notorious BATs from blood of septic patients; 2 applicability in parallel with conventional treatments; 3 potential to minimize side effects of the malady; 4 applicability for a vast range of BATs; 5 potential to eliminate contact of BATs with internal tissues and organs; 6 tolerability by patients sensitive to antiserum injections; 7 capability for universal application; 8 affectivity when antibiotic-resistant bacteria are involved and the physician has no or limited access to appropriate antibiotics; and 10 being a single-use, disposable, and stand-alone device. Before using it for clinical trials in

  12. Neurocutaneous syndrome: A prospective study

    Directory of Open Access Journals (Sweden)

    Radheshyam Purkait

    2011-01-01

    Full Text Available Background: Neurocutaneous syndromes (NCS are a group of genetic disorders that produce a variety of developmental abnormalities of the skin along with an increased risk of neurological complications. Cutaneous manifestations usually appear early in life and progress with time, but neurological features generally present at a later age. There is a paucity of data regarding the evolution of skin lesions and their correlation with the central nervous system involvement in children. Aim: The primary objective was to track the course of skin lesions in various forms of NCS in the pediatric age group. Our secondary aim was to assess whether there was any predictive value of the lesions in relation to the neurological manifestations. Materials and Methods: This prospective longitudinal study was conducted at a tertiary care pediatric dermatology referral clinic of the Institute of Child Health, Kolkata, West Bengal. Children between the age group 0 and 12 years were included in the study on the basis of standard diagnostic criteria for different NCS, during the period from March, 2000 to February, 2004, and each of the enrolled cases were followed up for a duration of six years. Results: The study population comprised of 67 children (35 boys, 32 girls.The mean age of presentation was 33.8±27.8 months (range 10 days to 111 months. The various forms of NCS observed was neurofibromatosis 1(NF1 (n=33, tuberous sclerosis complex (TSC (n=23, Sturge Weber syndrome (n=6, ataxia telangiectasia (n=2, PHACE syndrome (n=1, incontinentia pigmenti (n=1, and hypomelanosis of Ito (n=1. The presentations were varied, ranging from predominantly cutaneous to primarily neurological, depending on the disease entity and age group concerned. There was a significant increase in the number of café au lait macules (CALMs with time (P=0.0002 in NF1, unlike that of hypopigmented macules of TSC (P=0.15. Statistically, no relation was documented between the evolution of skin

  13. Phase behavior in diffraction

    International Nuclear Information System (INIS)

    Checon, A.

    1983-01-01

    Theoretical formulation of a straight edge diffraction shows a phase difference of π/2 between the incoming and diffracted waves. Experiments using two straight edges do not confirm the π/2 difference but suggest that the incoming wave is in phase with the wave diffracted into the shadowed region of the edge and out of phase by a factor of π with the wave diffracted into the illuminated region. (Author) [pt

  14. Phase 4B: Commissioning

    Science.gov (United States)

    1998-08-01

    Report 26-04-R-014 Revision: 0 Phase 3D , entitled "Integration" (Contract number N68171-94-C-9066), addressed the preliminary experiments being...a set of operating procedures were prepared for general use, Schofield and Steedman(1995). Phase 3D was followed by Phases 4 (Contract Number N68171...For example, the Druck pore pressure transducers which were recommended to the Army had already been used at 300g in the drum centrifuge. ANS&A

  15. Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials.

    Science.gov (United States)

    Mhlanga, Felix G; Noguchi, Lisa; Balkus, Jennifer E; Kabwigu, Samuel; Scheckter, Rachel; Piper, Jeanna; Watts, Heather; O'Rourke, Colin; Torjesen, Kristine; Brown, Elizabeth R; Hillier, Sharon L; Beigi, Richard

    2018-02-01

    Safety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials. The Microbicide Trials Network (MTN)-016 study is a multinational prospective pregnancy exposure registry designed to capture pregnancy and neonatal outcomes. Studies currently contributing data to this registry included phase I and II safety trials with planned exposures to candidate HIV prevention agents, as well as phase IIB and III efficacy trials capturing data on pregnancy and infant outcomes following inadvertent fetal exposure during study participation. To date, participants from two phase I studies and two effectiveness trials have participated in MTN-016, resulting in 420 pregnant women and 381 infants enrolled. Infant retention has been high, with 329 of 381 (86%) infants completing the 12-month follow-up visit. In a research setting context, it is feasible to establish and implement a prospective, multinational HIV chemoprophylaxis pregnancy registry that will generate pregnancy exposure data in a robust fashion.

  16. Dual phase evolution

    CERN Document Server

    Green, David G; Abbass, Hussein A

    2014-01-01

    This book explains how dual phase evolution operates in all these settings and provides a detailed treatment of the subject. The authors discuss the theoretical foundations for the theory, how it relates to other phase transition phenomena and its advantages in evolutionary computation and complex adaptive systems. The book provides methods and techniques to use this concept for problem solving. Dual phase evolution concerns systems that evolve via repeated phase shifts in the connectivity of their elements. It occurs in vast range of settings, including natural systems (species evolution, landscape ecology, geomorphology), socio-economic systems (social networks) and in artificial systems (annealing, evolutionary computing).

  17. Modeling of liquid phases

    CERN Document Server

    Soustelle, Michel

    2015-01-01

    This book is part of a set of books which offers advanced students successive characterization tool phases, the study of all types of phase (liquid, gas and solid, pure or multi-component), process engineering, chemical and electrochemical equilibria, and the properties of surfaces and phases of small sizes. Macroscopic and microscopic models are in turn covered with a constant correlation between the two scales. Particular attention has been given to the rigor of mathematical developments. This second volume in the set is devoted to the study of liquid phases.

  18. Photovoltaic Wire, Phase I

    Data.gov (United States)

    National Aeronautics and Space Administration — This Small Business Innovation Research Phase I project will investigate a new architecture for photovoltaic devices based on nanotechnology: photovoltaic wire. The...

  19. Thermodynamically stable blue phases.

    Science.gov (United States)

    Castles, F; Morris, S M; Terentjev, E M; Coles, H J

    2010-04-16

    We show theoretically that flexoelectricity stabilizes blue phases in chiral liquid crystals. Induced internal polarization reduces the elastic energy cost of splay and bend deformations surrounding singular lines in the director field. The energy of regions of double twist is unchanged. This in turn reduces the free energy of the blue phase with respect to that of the chiral nematic phase, leading to stability over a wider temperature range. The theory explains the discovery of large temperature range blue phases in highly flexoelectric "bimesogenic" and "bent-core" materials, and predicts how this range may be increased further.

  20. Original and cumulative prospect theory: a discussion of empirical differences

    NARCIS (Netherlands)

    Wakker, P.P.; Fennema, H.

    1997-01-01

    This note discusses differences between prospect theory and cumulative prospect theory. It shows that cumulative prospect theory is not merely a formal correction of some theoretical problems in prospect theory, but it also gives different predictions. Experiments are described that favor cumulative

  1. Phase Contrast Imaging

    International Nuclear Information System (INIS)

    Menk, Ralf Hendrik

    2008-01-01

    All standard (medical) x-ray imaging technologies, rely primarily on the amplitude properties of the incident radiation, and do not depend on its phase. This is unchanged since the discovery by Roentgen that the intensity of an x-ray beam, as measured by the exposure on a film, was related to the relative transmission properties of an object. However, recently various imaging techniques have emerged which depend on the phase of the x-rays as well as the amplitude. Phase becomes important when the beam is coherent and the imaging system is sensitive to interference phenomena. Significant new advances have been made in coherent optic theory and techniques, which now promise phase information in medical imaging. The development of perfect crystal optics and the increasing availability of synchrotron radiation facilities have contributed to a significant increase in the application of phase based imaging in materials and life sciences. Unique source characteristics such as high intensity, monochromaticity, coherence and high collimating provide an ideal source for advanced imaging. Phase contrast imaging has been applied in both projection and computed tomography modes, and recent applications have been made in the field of medical imaging. Due to the underlying principle of X-ray detection conventional image receptors register only intensities of wave fields and not their phases. During the last decade basically five different methods were developed that translate the phase information into intensity variations. These methods are based on measuring the phase shift φ directly (using interference phenomena), the gradient ∇ φ , or the Laplacian ∇ 2 φ. All three methods can be applied to polychromatic X-ray sources keeping in mind that the native source is synchrotron radiation, featuring monochromatic and reasonable coherent X-ray beams. Due to the vast difference in the coefficients that are driven absorption and phase effects (factor 1,000-10,000 in the energy

  2. Bushehr Elderly Health (BEH) Programme, phase I (cardiovascular system)

    OpenAIRE

    Ostovar, Afshin; Nabipour, Iraj; Larijani, Bagher; Heshmat, Ramin; Darabi, Hossein; Vahdat, Katayoun; Ravanipour, Maryam; Mehrdad, Neda; Raeisi, Alireza; Heidari, Gholamreza; Shafiee, Gita; Haeri, Mohammadjavad; Pourbehi, Mohammadreza; Sharifi, Farshad; Noroozi, Azita

    2015-01-01

    Purpose The main objective of the Bushehr Elderly Health Programme, in its first phase, is to investigate the prevalence of cardiovascular risk factors and their association with major adverse cardiovascular events. Participants Between March 2013 and October 2014, a total of 3000 men and women aged ?60?years, residing in Bushehr, Iran, participated in this prospective cohort study (participation rate=90.2%). Findings to date Baseline data on risk factors, including demographic and socioecono...

  3. Military nuclear activities. Strategic prospects

    International Nuclear Information System (INIS)

    Coldefy, Alain; Wodka-Gallien, Philippe; Tertrais, Bruno; Rouillard, Gwendal; Widemann, Thierry; Guillaume, Louis-Michel; Steininger, Philippe; Guillemette, Alain; Amabile, Jean-Christophe; Granger-Veyron, Nicolas; Carbonnieres, Hubert de; Roche, Nicolas; Guillou, Herve; Bouvier, Antoine; Pastre, Bertrand; Baconnet, Alexis; Monsonis, Guillem; Brisset, Jean-Vincent; Hemez, Remy; Tchernega, Vladimir; Wedin, Lars; Dumoulin, Andre; Razoux, Pierre; Migault, Philippe; Wilson, Ward; Maillard, Benjamin de; Aichi, Leila; Charvoz, Ivan; Rousset, Valery; Lespinois, Jerome de; Kempf, Olivier; Dufourcq, Jean; Gere, Francois; Mauro, Frederic; Delort Laval, Gabriel; Charaix, Patrick; Norlain, Bernard; Collin, Jean-Marie; Jourdier, Francois

    2015-01-01

    This special dossier aims at providing some key articles about France's deterrence doctrine. It provides a comprehensive overview of the challenges and questions about military nuclear activities and opens up some future prospects about this question. The dossier comprises 37 papers dealing with: 1 - Military nuclear activities: yesterday, today, tomorrow (Coldefy, A.); 2 - Deterrence according to French President Francois Hollande: continuation, precision and inflexions (Tertrais, B.); 3 - French deterrence warrantor of our independence in the 21. century (Rouillard, G.); 4 - The deterrence concept prior to the nuclear weapon era (Widemann, T.); 5 - France: the strategic marine force in operation (Guillaume, L.M.); 6 - Relevance of the airborne component in the nuclear deterrence strategy (Steininger, P.); 7 - Deterrence stakes for the Directorate General of Armaments (Guillemette, A.); 8 - The Charles-de-Gaulle aircraft carrier: the deterrence voice from the sea (Wodka-Gallien, P.); 9 - Deterrence: missions of the army's radiation protection department (Amabile, J.C.; Granger-Veyron, N.; Carbonnieres, H. de); 10 - The French Atomic Energy Commission (CEA) and the French defense strategy (Roche, N.); 11 - DCNS, general contractor in the service of deterrence (Guillou, H.); 12 - The airborne nuclear component for MBDA (Bouvier, A.); 13 - Ballistic missile of the marine nuclear component: industrial stakes (Pastre, B.); 14 - Beyond defense against missiles: a US anti-deterrence strategy (Baconnet, A.); 15 - Deterrence dynamics in South Asia (Monsonis, G.); 16 - Military nuclear activities in East Asia (Brisset, J.V.); 17 - North Korea would own nuclear weapons, so what? (Hemez, R.); 18 - About the risk of nuclear warfare in Europe (Tchernega, V.); 19 - Present day nuclear activities: deterrence and gesticulation (Wedin, L.); 20 - Belgian F-16 replacement: nuclear dimension (Dumoulin, A.); 21 - Israel and nuclear deterrence (Razoux, P.); 22 - Nuclear

  4. paraelectric phase transition

    Indian Academy of Sciences (India)

    at% of La, x = 3, 5, 6, 10 and 12] have been measured in the frequency range 1 Hz–1 MHz using the vector impedance ... The ferroelectric phase transition is diffuse in nature and broadening of the peak increases with La content. Keywords. PLZT ..... formation from rhombohedral–tetragonal–cubic phase with increase in ...

  5. Simulation of phase structures

    International Nuclear Information System (INIS)

    Lawson, J.

    1995-01-01

    This memo outlines a procedure developed by the author to extract information from phase measurements and produce a simulated phase structure for use in modeling optical systems, including characteristic optics for the Beamlet and NIF laser systems. The report includes an IDL program listing

  6. UPVG phase 2 report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-08-01

    The Utility PhotoVoltaic Group (UPVG), supported by member dues and a grant from the US Department of Energy, has as its mission the acceleration of the use of cost-effective small-scale and emerging large-scale applications of photovoltaics for the benefit of electric utilities and their customers. Formed in October, 1992, with the support of the American Public Power Association, Edison Electric Institute, and the National Rural Electric Cooperative Association, the UPVG currently has 90 members from all sectors of the electric utility industry. The UPVG`s efforts as conceived were divided into four phases: Phase 0--program plan; Phase 1--organization and strategy development; Phase 2--creating market assurance; and Phase 3--higher volume purchases. The Phase 0 effort developed the program plan and was completed early in 1993. The Phase 1 goal was to develop the necessary background information and analysis to lead to a decision as to which strategies could be undertaken by utilities to promote greater understanding of PV markets and achieve increased volumes of PV purchases. This report provides the details of the UPVG`s Phase 2 efforts to initiate TEAM-UP, its multiyear, 50-MW hardware initiative.

  7. UPVG phase 2 report

    International Nuclear Information System (INIS)

    1995-08-01

    The Utility PhotoVoltaic Group (UPVG), supported by member dues and a grant from the US Department of Energy, has as its mission the acceleration of the use of cost-effective small-scale and emerging large-scale applications of photovoltaics for the benefit of electric utilities and their customers. Formed in October, 1992, with the support of the American Public Power Association, Edison Electric Institute, and the National Rural Electric Cooperative Association, the UPVG currently has 90 members from all sectors of the electric utility industry. The UPVG's efforts as conceived were divided into four phases: Phase 0--program plan; Phase 1--organization and strategy development; Phase 2--creating market assurance; and Phase 3--higher volume purchases. The Phase 0 effort developed the program plan and was completed early in 1993. The Phase 1 goal was to develop the necessary background information and analysis to lead to a decision as to which strategies could be undertaken by utilities to promote greater understanding of PV markets and achieve increased volumes of PV purchases. This report provides the details of the UPVG's Phase 2 efforts to initiate TEAM-UP, its multiyear, 50-MW hardware initiative

  8. (Afrique francophone) - Phase III

    International Development Research Centre (IDRC) Digital Library (Canada)

    Programme de troisième cycle interuniversitaire en économie (Afrique francophone) - Phase III. Les deux premières phases du projet ... L'Initiative des conseils subventionnaires de la recherche scientifique en Afrique subsaharienne remporte le prix de la diplomatie scientifique. L'Initiative des conseils subventionnaires de ...

  9. The immune response during the luteal phase of the ovarian cycle : increasing sensitivity of human monocytes to endotoxin

    NARCIS (Netherlands)

    Bouman, Annechien; Moes, H; Heineman, MJ; de Leij, LFMH; Faas, MM

    Objective: To test the hypothesis that during the luteal phase of the human ovarian cycle, as compared with the follicular phase, the percentage of cytokines producing peripheral monocytes after in vitro stimulation with endotoxin is increased. Design: Prospective study. Setting: Academic research

  10. Smooth Phase Interpolated Keying

    Science.gov (United States)

    Borah, Deva K.

    2007-01-01

    Smooth phase interpolated keying (SPIK) is an improved method of computing smooth phase-modulation waveforms for radio communication systems that convey digital information. SPIK is applicable to a variety of phase-shift-keying (PSK) modulation schemes, including quaternary PSK (QPSK), octonary PSK (8PSK), and 16PSK. In comparison with a related prior method, SPIK offers advantages of better performance and less complexity of implementation. In a PSK scheme, the underlying information waveform that one seeks to convey consists of discrete rectangular steps, but the spectral width of such a waveform is excessive for practical radio communication. Therefore, the problem is to smooth the step phase waveform in such a manner as to maintain power and bandwidth efficiency without incurring an unacceptably large error rate and without introducing undesired variations in the amplitude of the affected radio signal. Although the ideal constellation of PSK phasor points does not cause amplitude variations, filtering of the modulation waveform (in which, typically, a rectangular pulse is converted to a square-root raised cosine pulse) causes amplitude fluctuations. If a power-efficient nonlinear amplifier is used in the radio communication system, the fluctuating-amplitude signal can undergo significant spectral regrowth, thus compromising the bandwidth efficiency of the system. In the related prior method, one seeks to solve the problem in a procedure that comprises two major steps: phase-value generation and phase interpolation. SPIK follows the two-step approach of the related prior method, but the details of the steps are different. In the phase-value-generation step, the phase values of symbols in the PSK constellation are determined by a phase function that is said to be maximally smooth and that is chosen to minimize the spectral spread of the modulated signal. In this step, the constellation is divided into two groups by assigning, to information symbols, phase values

  11. A phased translation function

    International Nuclear Information System (INIS)

    Read, R.J.; Schierbeek, A.J.

    1988-01-01

    A phased translation function, which takes advantage of prior phase information to determine the position of an oriented mulecular replacement model, is examined. The function is the coefficient of correlation between the electron density computed with the prior phases and the electron density of the translated model, evaluated in reciprocal space as a Fourier transform. The correlation coefficient used in this work is closely related to an overlap function devised by Colman, Fehlhammer and Bartels. Tests with two protein structures, one of which was solved with the help of the phased translation function, show that little phase information is required to resolve the translation problem, and that the function is relatively insensitive to misorientation of the model. (orig.)

  12. Developing Mathematical Resilience of Prospective Math Teachers

    Science.gov (United States)

    Ariyanto, L.; Herman, T.; Sumarmo, U.; Suryadi, D.

    2017-09-01

    Prospective math teachers need to develop positive adaptive attitudes toward mathematics that will enable them to continue learning despite having to deal with obstacles and difficulties. This research focuses on the resilience improvement of the prospective mathematic teachers after being treated using problem-based learning based on their basic knowledge on mathematic and their overall knowledge on math. This research used only one group for pre-test and post-test. The result of this research shows that there is improvement on prospective teachers’ resilience after they were given treatment using problem-based learning. One of the factors causing the resilience improvement of the prospective mathematic teachers is the instructions on students’ work sheet. In the instructions, stud ents were asked to write difficulties in solving math problems as well as write down the solution they take to overcome them. This research can be used as a reference for other researchers who want to do the same research related on students’ resiliency o n math and or math lecturers to improve the resilience of prospective teachers to be resilient teachers on math in the future.

  13. Basic data for uranium prospecting in Argentina

    International Nuclear Information System (INIS)

    Belluco, A.; Rodriguez, E.; Martinez, C.; Marinkeff, K.

    1977-01-01

    After dealing briefly with the geochemical cycle of uranium in the earth's crust, and indicating the principal conditions under which different types of deposits are formed, the paper goes on to determine the uraniferous are of mainland Argentina (approximately 900000 km 2 ). Since evidence for the presence of uranium and other radioactive elements in many parts of the country has long been available, an attempt was made to systemize the existing information and classify the uraniferous sites so as to determine their temporal, spatial and genetic relationships with the different containing rocks. In addition, a study was made of the factors which contribute to the concentration of uranium in rocks which are accessible to prospecting (litho-stratigraphy, geological history, mettallogenic cycles, etc.). On the basis of these studies and considering the regional geology of Argentina, 21 ''regional environments'' were defined with varying degrees of probability of containing uranium; these environments will be submitted to long-term regional prospecting studies. It was necessary, however, to make a further sub-division into more homogeneous units with more clearly graded levels of priority, with the result that there are 65 ''prospecting units''. Each of these units, in order of priority, will be subjected to systematic prospecting. Exploratory work on a suitable scale will be carried out in the ''uraniferous'' districts of the ''prospecting units''. The main features of Argentine geology relating to the likelihood of uranium occurrences are briefly described, and maps of the large geotechtonic areas and the ''regional environments'' are included. (author)

  14. Scenarios planning: the evolution of prospective thinking

    Directory of Open Access Journals (Sweden)

    Maurício Fernandes Pereira

    2005-01-01

    Full Text Available The world is changing even more than before. Around the world, the organizational stability is in face of threats unnoticed before, due to technologic innovations, uncontrolled financial markets, up to date customers, and an observant society and government, in order to control the organizations’ social and environmental responsibilities. To face this threats, organizations needs to worry even more, renew its long range planning systems, and use Prospective Scenaries to find out, in a better way, the dynamic forces that will preveil in the next years. This paper seeks to clarify the source of prospective thinking that has created and developed this tool. Prospective Thinking is considered, nowadays, one of most innovatives tools used by the strategic management in organizations.

  15. Prospect theory for online financial trading.

    Science.gov (United States)

    Liu, Yang-Yu; Nacher, Jose C; Ochiai, Tomoshiro; Martino, Mauro; Altshuler, Yaniv

    2014-01-01

    Prospect theory is widely viewed as the best available descriptive model of how people evaluate risk in experimental settings. According to prospect theory, people are typically risk-averse with respect to gains and risk-seeking with respect to losses, known as the "reflection effect". People are much more sensitive to losses than to gains of the same magnitude, a phenomenon called "loss aversion". Despite of the fact that prospect theory has been well developed in behavioral economics at the theoretical level, there exist very few large-scale empirical studies and most of the previous studies have been undertaken with micro-panel data. Here we analyze over 28.5 million trades made by 81.3 thousand traders of an online financial trading community over 28 months, aiming to explore the large-scale empirical aspect of prospect theory. By analyzing and comparing the behavior of winning and losing trades and traders, we find clear evidence of the reflection effect and the loss aversion phenomenon, which are essential in prospect theory. This work hence demonstrates an unprecedented large-scale empirical evidence of prospect theory, which has immediate implication in financial trading, e.g., developing new trading strategies by minimizing the impact of the reflection effect and the loss aversion phenomenon. Moreover, we introduce three novel behavioral metrics to differentiate winning and losing traders based on their historical trading behavior. This offers us potential opportunities to augment online social trading where traders are allowed to watch and follow the trading activities of others, by predicting potential winners based on their historical trading behavior.

  16. Prospect theory for online financial trading.

    Directory of Open Access Journals (Sweden)

    Yang-Yu Liu

    Full Text Available Prospect theory is widely viewed as the best available descriptive model of how people evaluate risk in experimental settings. According to prospect theory, people are typically risk-averse with respect to gains and risk-seeking with respect to losses, known as the "reflection effect". People are much more sensitive to losses than to gains of the same magnitude, a phenomenon called "loss aversion". Despite of the fact that prospect theory has been well developed in behavioral economics at the theoretical level, there exist very few large-scale empirical studies and most of the previous studies have been undertaken with micro-panel data. Here we analyze over 28.5 million trades made by 81.3 thousand traders of an online financial trading community over 28 months, aiming to explore the large-scale empirical aspect of prospect theory. By analyzing and comparing the behavior of winning and losing trades and traders, we find clear evidence of the reflection effect and the loss aversion phenomenon, which are essential in prospect theory. This work hence demonstrates an unprecedented large-scale empirical evidence of prospect theory, which has immediate implication in financial trading, e.g., developing new trading strategies by minimizing the impact of the reflection effect and the loss aversion phenomenon. Moreover, we introduce three novel behavioral metrics to differentiate winning and losing traders based on their historical trading behavior. This offers us potential opportunities to augment online social trading where traders are allowed to watch and follow the trading activities of others, by predicting potential winners based on their historical trading behavior.

  17. Circadian phase preference in college students: relationships with psychological functioning and academics.

    Science.gov (United States)

    Taylor, Daniel J; Clay, Kendra C; Bramoweth, Adam D; Sethi, Kevin; Roane, Brandy M

    2011-07-01

    The current study offers a comprehensive assessment of psychosocial functioning and academic performance in relation to circadian phase preference in a US sample of undergraduate college students (N = 838), aged 17-26 (M = 19.78, SD = 1.89). Women had greater morning preference than men, and seniors had greater morning preference than freshmen. Circadian phase preference, fatigue, perceived stress, depression, anxiety, and substance use were assessed cross-sectionally and grade point average (GPA) was assessed prospectively. Evening phase preference was related to higher levels of fatigue, alcohol and caffeine use, and worse academic performance than morning or intermediate phase preferences.

  18. Quantum spin Hall phases

    International Nuclear Information System (INIS)

    Murakami, Shuichi

    2009-01-01

    We review our recent theoretical works on the quantum spin Hall effect. First we compare edge states in various 2D systems, and see whether they are robust or fragile against perturbations. Through the comparisons we see the robust nature of edge states in 2D quantum spin Hall phases. We see how it is protected by the Z 2 topological number, and reveal the nature of the Z 2 topological number by studying the phase transition between the quantum spin Hall and insulator phases. We also review our theoretical proposal of the ultrathin bismuth film as a candidate to the 2D quantum spin Hall system. (author)

  19. Three-Phase PLLs

    DEFF Research Database (Denmark)

    Golestan, Saeed; Guerrero, Josep M.; Vasquez, Juan C.

    2017-01-01

    A phase-locked loop (PLL) is a nonlinear negativefeedback control system that synchronizes its output in frequency as well as in phase with its input. PLLs are now widely used for the synchronization of power electronics-based converters and also for monitoring and control purposes in different...... engineering fields. In recent years, there have been many attempts to design more advanced PLLs for three-phase applications. The aim of this paper is to provide overviews of these attempts, which can be very useful for engineers and academic researchers....

  20. Phase transformation and diffusion

    CERN Document Server

    Kale, G B; Dey, G K

    2008-01-01

    Given that the basic purpose of all research in materials science and technology is to tailor the properties of materials to suit specific applications, phase transformations are the natural key to the fine-tuning of the structural, mechanical and corrosion properties. A basic understanding of the kinetics and mechanisms of phase transformation is therefore of vital importance. Apart from a few cases involving crystallographic martensitic transformations, all phase transformations are mediated by diffusion. Thus, proper control and understanding of the process of diffusion during nucleation, g

  1. Martensitic phase transitions

    Energy Technology Data Exchange (ETDEWEB)

    Petry, W.; Neuhaus, J. [Techn. Universitaet Muenchen, Physik Department E13, Munich (Germany)

    1996-11-01

    Many elements transform from a high temperature bcc phase to a more dense packed temperature phase. The great majority of these transitions are of 1st order, displacive and reconstructive. The lattice potentials which govern these martensitic transitions can be probed by inelastic neutron scattering, thereby answering fundamental questions like : Will the transition be announced by dynamical or static fluctuations? What are the trajectories for the displacements needed for the transformation? Does the vibrational entropy stabilize the high temperature phase? Are the unusual transport properties in these materials related to their ability to transform? (author) 17 figs., 1 tab., 46 refs.

  2. SELF ESTEEM OF PROSPECTIVE SECONDARY TEACHERS

    OpenAIRE

    A. D. Jeyanthy Victoria; Dr. G. Subramonian

    2017-01-01

    Self-esteem is an important aspect in the happy and peaceful living of individuals. It is a feeling of ‘being good’ of one’s own self. The current study explored the level of self-esteem and significant difference in self-esteem among the prospective secondary teachers with regard to gender, locality and nature of the teacher training institute. The prospective secondary teachers (N=665) studying in the teacher training institutes were surveyed using Self Esteem Scale constructed and standard...

  3. The Boeing prospective study and beyond.

    Science.gov (United States)

    Volinn, E; Spratt, K F; Magnusson, M; Pope, M H

    2001-07-15

    The Boeing prospective study was reviewed. The Boeing prospective study, comprising two articles, was a large field study that explored why workers would or would not report occupational back pain problems. The most immediate objective was to determine the extent to which conclusions drawn from the Boeing prospective study withstand critical examination. The ultimate purpose of this review was to develop guidelines for field studies of back pain in industry. For more than a century, researchers have noted great variability among individuals in the reporting of back pain, but the explanations posed for this variability have been inconsistent. Because findings gain credibility roughly to the extent that they bear on the world outside the laboratory, field studies in particular hold great potential for clarifying the underlying explanation for individual variability in back pain reporting. The Boeing prospective study was a large and ambitious field study that examined this issue. The Boeing prospective study was examined through the lens of research conducted since it was published. The review used both the methodological and substantive literature. The Boeing prospective study, based on a minority of workers originally solicited to participate in it (33-41%), accounted for 7% of the variation in why workers would or would not report a back pain problem. A number of issues that may have biased its results toward the null are examined. The highlighting of the Boeing prospective study's limitations may be instructive not so much to criticize this one particular study but, rather, to anticipate problems that in general may be encountered in field studies of back pain in industry. Looking beyond the Boeing prospective study, the following guidelines for the conduct of such studies may be proposed: 1) Study designs should be based on explanations from which testable hypotheses may be derived; 2) Subgroups within the more general category of "back pain" should be

  4. Quality criteria for phase change materials selection

    International Nuclear Information System (INIS)

    Vitorino, Nuno; Abrantes, João C.C.; Frade, Jorge R.

    2016-01-01

    Highlights: • Selection criteria of phase change materials for representative applications. • Selection criteria based on reliable solutions for latent heat transfer. • Guidelines for the role of geometry and heat transfer mechanisms. • Performance maps based on PCM properties, operating conditions, size and time scales. - Abstract: Selection guidelines are primary criterion for optimization of materials for specific applications in order to meet simultaneous and often conflicting requirements. This is mostly true for technologies and products required to meet the main societal needs, such as energy. In this case, gaps between supply and demand require strategies for energy conversion and storage, including thermal storage mostly based on phase change materials. Latent heat storage is also very versatile for thermal management and thermal control by allowing high storage density within narrow temperature ranges without strict dependence between stored thermal energy and temperature. Thus, this work addressed the main issues of latent heat storage from a materials selection perspective, based on expected requirements of applications in thermal energy storage or thermal regulation. Representative solutions for the kinetics of latent heat charge/discharge were used to derive optimization guidelines for high energy density, high power, response time (from fast response to thermal inertia), etc. The corresponding property relations were presented in graphical forms for a wide variety of prospective phase change materials, and for wide ranges of operating conditions, and accounting for changes in geometry and mechanisms.

  5. Brane Craft Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This effort will further develop the active membrane spacecraft concept called "Brane Craft" initially studied in a NIAC Phase I grant. The Brane Craft is an...

  6. Phase transitions modern applications

    CERN Document Server

    Gitterman, Moshe

    2014-01-01

    This book provides a comprehensive review of the theory of phase transitions and its modern applications, based on the five pillars of the modern theory of phase transitions i.e. the Ising model, mean field, scaling, renormalization group and universality. This expanded second edition includes, along with a description of vortices and high temperature superconductivity, a discussion of phase transitions in chemical reaction and moving systems. The book covers a close connection between phase transitions and small world phenomena as well as scale-free systems such as the stock market and the Internet. Readership: Scientists working in different fields of physics, chemistry, biology and economics as well as teaching material for undergraduate and graduate courses.

  7. Coaxial phased array antenna

    Science.gov (United States)

    Ellis, H., Jr.

    1980-08-01

    A coaxial antenna array for communicating circularly polarized electromagnetic radiation is disclosed. A pair of open ended antenna cavities is coaxially constructed and operates by excitation of linear radiation elements arranged within each of the cavities. A pair of crossed dipole radiation devices is centered within the inner cavity and operated by means of a phase shifting network circuit to transmit as well as receive circularly polarized radiation. Four monopole radiation devices are symmetrically arranged to operate in the outer cavity in phase quadrature by means of the phase shifting network circuit to both transmit and receive circularly polarized electromagnetic radiation. Combined operation of the two antenna cavities with a 180 deg phase differential between the fields related to the two antenna cavities provides a broad beam, relatively wide frequency bandwidth communication capability. Particular embodiments disclosed feature a generally square cavity array as well as a circular cavity array.

  8. Theory of alloy phases

    International Nuclear Information System (INIS)

    Watson, R.E.; Ehrenreich, H.; Bennett, L.H.

    1977-01-01

    Various non-thermodynamic approaches to understanding and predicting phase diagrams are explored from the viewpoint of solid-state physics. The review is intended to indicate the scope of activity and some of the progress which has been made

  9. Disordered adsorbate phases

    Science.gov (United States)

    Rys, Franz S.

    1985-04-01

    The occurrence of disordered phases at low temperatures in adsorbed monolayers, as shown recently in a domain wall model, is discussed, the main results are summarized and some relevant experimental systems are mentionned.

  10. Now entering phase two...

    CERN Multimedia

    Katarina Anthony

    2012-01-01

    Building on the success of their feasibility phase, the CLIC test facility, CTF3, has just launched into a five-year project development phase. This will involve detailed performance optimisation studies, marking the project’s transition from pure research and development to prototyping and construction.   CLIC accelerator modules under construction at CERN. “With the feasibility phase now complete, we have established that CLIC can be built,” says Roberto Corsini, CLIC Collaboration spokesperson. “Now we want to be sure that it can provide the luminosity and energy performance needed. We will be looking at the engineering, performance and cost of a real CLIC machine also seeing if we can reduce it.” CTF3’s second phase will focus on selected performance-related research areas for further investigation. The largest of these involves the construction and testing of several authentic CLIC accelerator modules that are currently being ...

  11. On-Orbit Prospective Echocardiography on International Space Station Crew

    Science.gov (United States)

    Hamilton, Douglas R.; Sargsyan, Ashot E.; Martin, David S.; Garcia, Kathleen M.; Melton, Shannon L.; Feiveson, Alan; Dulchavsky, Scott A.

    2010-01-01

    Introduction A prospective trial of echocardiography was conducted on of six crewmembers onboard the International Space Station. The main objective was to determine the efficacy of remotely guided tele-echocardiography, including just-in-time e-training methods and determine what "space normal" echocardiographic data is. Methods Each crewmember operator (n=6) had 2-hour preflight training. Baseline echocardiographic data were collected 55 to 167days preflight. Similar equipment was used in each 60-minute in-flight session (mean microgravity exposure - 114 days (34 -- 190)). On Orbit ultrasound operators used an e-learning system within 24h of these sessions. Expert assistance was provided using ultrasound video downlink and two-way voice. Testing was repeated 5 to 16 days after landing. Separate ANOVA was used on each echocardiographic variable (n=33). Within each ANOVA, three tests were made: a) effect of mission phase (preflight, in-flight, post flight); b) effect of echo technician (two technicians independently analyzed the data); c) interaction between mission phase and technician. Results Nine rejections of the null hypothesis (mission phase or technician or both had no effect) were discovered and considered for follow up. Of these, six rejections were for significant technician effects, not as a result of space flight. Three rejections of the null hypothesis (Aortic Valve time velocity integral, Mitral E wave Velocity and heart rate) were attributable to space flight, however determined not to be clinically significant. No rejections were due to the interaction between technician and space flight. Conclusion No consistent clinically significant effects of long-duration space flight were seen in echocardiographic variables of the given group of subjects.

  12. Vapor Compressor Driven Hybrid Two-Phase Loop, Phase I

    Data.gov (United States)

    National Aeronautics and Space Administration — This Small Business Innovation Research Phase I project will demonstrate a vapor compressor driven hybrid two-phase loop technology. The hybrid two-phase loop...

  13. Cosmological phase transitions

    International Nuclear Information System (INIS)

    Kolb, E.W.

    1987-01-01

    If the universe stated from conditions of high temperature and density, there should have been a series of phase transitions associated with spontaneous symmetry breaking. The cosmological phase transitions could have observable consequences in the present Universe. Some of the consequences including the formation of topological defects and cosmological inflation are reviewed here. One of the most important tools in building particle physics models is the use of spontaneous symmetry breaking (SSB). The proposal that there are underlying symmetries of nature that are not manifest in the vacuum is a crucial link in the unification of forces. Of particular interest for cosmology is the expectation that are the high temperatures of the big bang symmetries broken today will be restored, and that there are phase transitions to the broken state. The possibility that topological defects will be produced in the transition is the subject of this section. The possibility that the Universe will undergo inflation in a phase transition will be the subject of the next section. Before discussing the creation of topological defects in the phase transition, some general aspects of high-temperature restoration of symmetry and the development of the phase transition will be reviewed. 29 references, 1 figure, 1 table

  14. Electron microscope phase enhancement

    Science.gov (United States)

    Jin, Jian; Glaeser, Robert M.

    2010-06-15

    A microfabricated electron phase shift element is used for modifying the phase characteristics of an electron beam passing though its center aperture, while not affecting the more divergent portion of an incident beam to selectively provide a ninety-degree phase shift to the unscattered beam in the back focal plan of the objective lens, in order to realize Zernike-type, in-focus phase contrast in an electron microscope. One application of the element is to increase the contrast of an electron microscope for viewing weakly scattering samples while in focus. Typical weakly scattering samples include biological samples such as macromolecules, or perhaps cells. Preliminary experimental images demonstrate that these devices do apply a ninety degree phase shift as expected. Electrostatic calculations have been used to determine that fringing fields in the region of the scattered electron beams will cause a negligible phase shift as long as the ratio of electrode length to the transverse feature-size aperture is about 5:1. Calculations are underway to determine the feasibility of aspect smaller aspect ratios of about 3:1 and about 2:1.

  15. Electron Holography: phases matter.

    Science.gov (United States)

    Lichte, Hannes

    2013-06-01

    Essentially, all optics is wave optics, be it with light, X-rays, neutrons or electrons. The information transfer from the object to the image can only be understood in terms of waves given by amplitude and phase. However, phases are difficult to measure: for slowly oscillating waves such as sound or low-frequency electromagnetic waves, phases can be measured directly; for high frequencies this has to be done by heterodyne detection, i.e. superposition with a reference and averaging over time. In optics, this is called interferometry. Because interference is mostly very difficult to achieve, phases have often been considered 'hidden variables' seemingly pulling the strings from backstage, only visible by their action on the image intensity. This was almost the case in conventional Electron Microscopy with the phase differences introduced by an object. However, in the face of the urgent questions from solid state physics and materials science, these phases have to be determined precisely, because they encode the most dominant object properties, such as charge distributions and electromagnetic fields. After more than six decades of very patient advancement, electron interferometry and holography offer unprecedented analytical facilities down to an atomic scale. Akira Tonomura has prominently contributed to the present state.

  16. Electrocardiographic-guided tip positioning technique for peripherally inserted central catheters in a Dutch teaching hospital: Feasibility and cost-effectiveness analysis in a prospective cohort study.

    Science.gov (United States)

    Bloemen, Arthur; Daniels, Anne M; Samyn, Martine G; Janssen, Roel Jl; Elshof, Jan-Willem

    2018-03-01

    Peripherally inserted central catheters are venous devices intended for short to medium periods of intravenous treatment. Positioning of the catheter tip at the cavoatrial junction is necessary for optimum performance of a peripherally inserted central catheter. In this study, safety, effectiveness and cost-effectiveness of electrocardiographic-guided peripherally inserted central catheter positioning in a Dutch teaching hospital were evaluated. All patients who received a peripherally inserted central catheter in 2016 using electrocardiographic guidance were compared to those where fluoroscopy guidance was used in a prospective non-randomized cohort study. Relevant data were extracted from electronic health records. Cost-effectiveness analysis was performed. A total of 162 patients received a peripherally inserted central catheter using fluoroscopy guidance and 103 patients using electrocardiographic guidance in 2016. No significant difference was found in malposition, infection or other complications between these groups. Due to personnel reduction and omission of fluoroscopy costs, cost reduction for each catheter insertion was €120 in the first year and, as a result of discounted acquisition costs, €190 in subsequent years. The positioning results and complication rate are comparable to the previously reported literature. The cost reduction may vary in different hospitals. Other benefits of the electrocardiographic-guided technique are omission of X-ray exposure and improved patient service. Implementation of electrocardiographic-guided tip positioning for peripherally inserted central catheter was safe and effective in this study and led to an improved high value and cost-conscious care.

  17. Rural renewable energy (prospects) in Estonia

    Energy Technology Data Exchange (ETDEWEB)

    Tomson, T. [Estonian Energy Research Institute, Tallinn (Estonia); Kaeaermann, L. [Estonian National Maritime Board, Tallinn (Estonia); Raesaar, P. [Tallinn Technological University, Tallinn (Estonia)

    1997-12-31

    Total potential share of renewables (biomass, wind, hydropower and solar) in Estonia is 35 %. Total real share (wood, wood chips) of renewables is only about 4.5 % (1995). The constrains and prospects of the development are discussed. The attention is focused on rural conditions

  18. A prospective study of gentamicin ototoxicity

    DEFF Research Database (Denmark)

    Winkel, O; Hansen, M M; Kaaber-Bühler, Søren

    2010-01-01

    of gentamicin did not rule out the possiblity of ototoxicity. These results urge the continuing of prospective studies and indicate that gentamicin should be used only as a link in the primary treatment of severe infection or in cases in which other, less toxic agents have failed....

  19. A prospective study of gentamicin ototoxicity

    DEFF Research Database (Denmark)

    Winkel, O; Hansen, M M; Kaaber-Bühler, Søren

    1978-01-01

    of gentamicin did not rule out the possiblity of ototoxicity. These results urge the continuing of prospective studies and indicate that gentamicin should be used only as a link in the primary treatment of severe infection or in cases in which other, less toxic agents have failed....

  20. Prospects of experimentally reachable beyond Standard Model ...

    Indian Academy of Sciences (India)

    2016-01-06

    Jan 6, 2016 ... Home; Journals; Pramana – Journal of Physics; Volume 86; Issue 2. Prospects of experimentally reachable beyond Standard Model physics in inverse see-saw motivated SO(10) GUT. Ram Lal Awasthi. Special: Supersymmetric Unified Theories and Higgs Physics Volume 86 Issue 2 February 2016 pp 223- ...

  1. Improving prospects for digitally enabled livelihoods among ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Improving prospects for digitally enabled livelihoods among marginalized communities in Egypt. Egypt's limited economic growth and high ... Specifically, the project will develop the first high quality, localized, and partially Arabized curriculum focused on creating digital and business skills. This curriculum could eventually ...

  2. Ecological value orientations of prospective secondary school ...

    African Journals Online (AJOL)

    A

    Key words: Dominant social paradigm, ecological value orientations, green development, new ecological paradigm, prospective teachers. .... pro-NEP view would be allied with the post-materialist values of frugality and conservation. ... possess accumulated practical knowledge of their environment through experience and ...

  3. Prospects and Constraints of Household Irrigation Practices ...

    African Journals Online (AJOL)

    Constraints and prospects of hand dug wells related to household irrigation were assessed in Hayelom watershed (~1045 ha), by evaluating groundwater suitability for irrigation, soil quality and impact of intervention. 181 hand dug wells have come into existence in the watershed due to intervention and benefiting about ...

  4. Exploring prospective language teachers' constructions of ...

    African Journals Online (AJOL)

    Teaching and learning in classrooms are discursively constructed in variations of the Initiation-Response-Feedback exchange pattern (Lee, 2007; Sinclair & Coulthard, 1991; ... At a more direct level, when we prompt prospective teachers to define the meanings they assign to key constructs in English Language Teaching,

  5. THE PROSPECTS, IMPACTS, AND RESEARCH CHALLENGES OF ...

    African Journals Online (AJOL)

    The benefits and impacts of enhanced cellulosic ethanol (CE) production, the major features of existing production processes, and some current research challenges of major pretreatment processes are presented. The prospects of enhanced CE production, especially in developing economies like Nigeria are highlighted.

  6. On the Prospects for Aristotelian Character Education

    Science.gov (United States)

    Lapsley, Daniel

    2016-01-01

    The prospects for Aristotelian character education (ACE) is considered. Seven important claims that should win wide acceptance are reviewed; and also two challenges that are impediments. I argue many of the assumptions of ACE turn out not to be distinctive. The conflation of realism and naturalism is ill-considered, and the account of…

  7. Prospective associations between loneliness and emotional intelligence

    NARCIS (Netherlands)

    Wols, A.C.; Scholte, R.H.J.; Qualter, P.

    2015-01-01

    Loneliness has been linked cross-sectionally to emotional skill deficits (e.g., Zysberg, 2012), but missing from the literature is a longitudinal examination of these relationships. The present study fills that gap by examining the prospective relationships between loneliness and emotional

  8. PROSPECTS AND CHALLENGES OF BIODIVERSITY IN

    African Journals Online (AJOL)

    losses due to pest and disease attack or unfavourable environmental conditions can be reduced. ... Prospects and challenges biodiversity in small—holder systems 53. It is thought that the subsequent dispersal of .... When measuring genetic diversity on-farm three important aspects should be considered. These.

  9. Recreation intervention with adolescent offenders: Prospects and ...

    African Journals Online (AJOL)

    International research provides contradicting results about the impact of recreation programmes on adolescent criminal behaviour. In addition, there is a dearth of South African data regarding the outcomes of recreation as therapeutic intervention with children in conflict with the law. This article investigates the prospects ...

  10. Future Prospects for Geographical Education in Slovenia

    Science.gov (United States)

    Resnic Planinc, Tatjana

    2011-01-01

    This paper deals with future prospects for geographical education in Slovenia, with special emphasis on the development and aims of the didactics of geography. The author discusses the past developm