Developing and piloting a peer mentoring intervention to reduce teenage pregnancy in looked-after children and care leavers: an exploratory randomised controlled trial.

PubMed

Mezey, Gillian; Meyer, Deborah; Robinson, Fiona; Bonell, Chris; Campbell, Rona; Gillard, Steve; Jordan, Peter; Mantovani, Nadia; Wellings, Kaye; White, Sarah

2015-10-01

Looked-after children (LAC) are at greater risk of teenage pregnancy than non-LAC, which is associated with adverse health and social consequences. Existing interventions have failed to reduce rates of teenage pregnancy in LAC. Peer mentoring is proposed as a means of addressing many of the factors associated with the increased risk of teenage pregnancy in this group. To develop a peer mentoring intervention to reduce teenage pregnancy in LAC. Phase I and II randomised controlled trial of a peer mentoring intervention for LAC; scoping exercise and literature search; national surveys of social care professionals and LAC; and focus groups and interviews with social care professionals, mentors and mentees. Three local authorities (LAs) in England. LAC aged 14-18 years (mentees/care as usual) and 19-25 years (mentors). Recruitment and training of mentors; randomisation and matching of mentors to mentees; and 1-year individual peer mentoring. pregnancy in LAC aged 14-18 years. sexual attitudes, behaviour and knowledge; psychological health; help-seeking behaviour; locus of control; and attachment style. A health economic evaluation was also carried out. In total, 54% of target recruitment was reached for the exploratory trial and 13 out of 20 mentors (65%) and 19 out of 30 LAC aged 14-18 years (63%) (recruited during Phases I and II) were retained in the research. The training programme was acceptable and could be manualised and replicated. Recruitment and retention difficulties were attributed to systemic problems and LA lack of research infrastructure and lack of additional funding to support and sustain such an intervention. Mentees appeared to value the intervention but had difficulty in meeting weekly as required. Only one in four of the relationships continued for the full year. A future Phase III trial would require the intervention to be modified to include provision of group and individual peer mentoring; internal management of the project, with support from an external agency such as a charity or the voluntary sector; funds to cover LA research costs, including the appointment of a dedicated project co-ordinator; a reduction in the lower age for mentee recruitment and an increase in the mentor recruitment age to 21 years; and the introduction of a more formal recruitment and support structure for mentors. Given the problems identified and described in mounting this intervention, a new development phase followed by a small-scale exploratory trial incorporating these changes would be necessary before proceeding to a Phase III trial. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 85. See the NIHR Journals Library website for further project information.

Fabrication of Natural Uranium UO 2 Disks (Phase II): Texas A&M Work for Others Summary Document

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gerczak, Tyler J.; Baldwin, Charles A.; Schmidlin, Joshua E.

The steps to fabricate natural UO 2 disks for an irradiation campaign led by Texas A&M University are outlined. The process was initiated with stoichiometry adjustment of parent, U 3O 8 powder. The next stage of sample preparation involved exploratory pellet pressing and sintering to achieve the desired natural UO 2 pellet densities. Ideal densities were achieved through the use of a bimodal powder size blend. The steps involved with disk fabrication are also presented, describing the coring and thinning process executed to achieve final dimensionality.

Consortium for Planning, Developing, and Implementing Exploratory Industrial Career Development Models (Phase I of Three Phases). Interim Report.

ERIC Educational Resources Information Center

Oregon State Univ., Corvallis.

The report describes the organizational phase of a project designed to create program models and supporting literature for exploratory industrial career development programs for grades seven to ten. The project was undertaken by Oregon State University in cooperation with the Oregon State Department of Education and involved the formation of a…

Exploratory Phase for Optimizing Lifetime Position 4 of the COS/FUV Detector

NASA Astrophysics Data System (ADS)

Roman-Duval, Julia; Indriolo, Nick; De Rosa, Gisella; Fox, Andrew; Oliveira, Cristina; Penton, Steve; Sahnow, David; Sonnentrucker, Paule; White, James

2018-05-01

The COS/FUV detector uses a microchannel plate, whose response (gain) decreases with usage, a process called gain-sag. To mitigate these gain-sag effects, COS/FUV science spectra are periodically moved to pristine locations of the detector, i.e. different lifetime positions (LP). Preparations for the move from LP3 to LP4 started with an exploratory phase between May and October 2016, while the LP4 move occurred on October 2, 2017. This ISR describes the LP4 exploratory phase, during which the feasibility of placing LP4 at -2.5'' below LP3 (-5'' below LP1) was examined, the effects of the LP4 move on the science quality and calibration accuracy of spectra were investigated, and the final location of LP4 (- 2.5'' below LP3) was determined. We describe in detail the strategy adopted for the LP4 exploratory phase to ensure that all potential issues were identified and resolved well in advance of the LP4 move.

Altered object exploration but not temporal order memory retrieval in an object recognition test following treatment of rats with the group II metabotropic glutamate receptor agonist LY379268.

PubMed

Lins, Brittney R; Ballendine, Stephanie A; Howland, John G

2014-02-07

Temporal order memory refers to the ability to distinguish past experiences in the order that they occurred. Temporal order memory for objects is often tested in rodents using spontaneous object recognition paradigms. The circuitry mediating memory in these tests is distributed and involves ionotropic glutamate receptors in the perirhinal cortex and medial prefrontal cortex. It is unknown what role, if any, metabotropic glutamate receptors have in temporal order memory for objects. The present experiment examined the role of metabotropic glutamate receptors in temporal memory retrieval using the group II metabotropic glutamate receptor selective agonist LY379268. Rats were trained on a temporal memory test with three phases: two sample phases (60 min between them) in which rats explored two novel objects and a test phase (60 min after the second sample phase) which included a copy of each object previously encountered. Under these conditions, we confirmed that rats showed a significant exploratory preference for the object presented during the first sample phase. In a second experiment, we found that LY379268 (0.3, 1.0, or 3.0mg/kg; i.p.; 30 min before the test phase) had no effect on temporal memory retrieval but dose-dependently reduced time spent exploring the objects. Our results show that enhancing mGluR2 activity under conditions when TM is intact does not influence memory retrieval. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Phase I/II evaluation of RV1001, a novel PI3Kδ inhibitor, in spontaneous canine lymphoma.

PubMed

Gardner, Heather L; Rippy, Sarah B; Bear, Misty D; Cronin, Kim L; Heeb, Heather; Burr, Holly; Cannon, Claire M; Penmetsa, Kumar V; Viswanadha, Srikant; Vakkalanka, Swaroop; London, Cheryl A

2018-01-01

RV1001 is a novel, potent, and selective PI3Kδ inhibitor. The purpose of this study was to evaluate the safety and efficacy of RV1001 in canine Non-Hodgkin lymphoma (NHL). Inhibition of endogenous pAKT by RV1001 in primary canine NHL cells was determined by Western blotting. A phase I study of RV1001 was performed in 21 dogs with naïve and drug resistant T and B-cell NHL to assess safety, pharmacokinetic profile, and response to therapy. The objective response rate was 62% (complete response (CR) n = 3; partial response (PR) n = 10), and responses were observed in both naïve and chemotherapy-resistant B and T cell NHL. This study provided the recommended starting dose for a phase II, non-pivotal, exploratory, open label multi-centered clinical trial in 35 dogs with naïve and drug resistant T and B-cell NHL, to further define the efficacy and safety profile of RV1001. The objective response rate in the phase II study was 77% (CR n = 1; PR n = 26). Clinical toxicities were primarily hepatobiliary and gastrointestinal, and were responsive to dose modifications and/or temporary drug discontinuation. Hepatotoxicity was the primary dose limiting toxicity. RV1001 exhibits good oral bioavailability, an acceptable safety profile, and biologic activity with associated inhibition of pAKT in dogs with B and T cell NHL. Data from these studies can be leveraged to help inform the design of future studies involving isoform-selective PI3K inhibitors in humans.

Development and validation of the Simulation Learning Effectiveness Inventory.

PubMed

Chen, Shiah-Lian; Huang, Tsai-Wei; Liao, I-Chen; Liu, Chienchi

2015-10-01

To develop and psychometrically test the Simulation Learning Effectiveness Inventory. High-fidelity simulation helps students develop clinical skills and competencies. Yet, reliable instruments measuring learning outcomes are scant. A descriptive cross-sectional survey was used to validate psychometric properties of the instrument measuring students' perception of stimulation learning effectiveness. A purposive sample of 505 nursing students who had taken simulation courses was recruited from a department of nursing of a university in central Taiwan from January 2010-June 2010. The study was conducted in two phases. In Phase I, question items were developed based on the literature review and the preliminary psychometric properties of the inventory were evaluated using exploratory factor analysis. Phase II was conducted to evaluate the reliability and validity of the finalized inventory using confirmatory factor analysis. The results of exploratory and confirmatory factor analyses revealed the instrument was composed of seven factors, named course arrangement, equipment resource, debriefing, clinical ability, problem-solving, confidence and collaboration. A further second-order analysis showed comparable fits between a three second-order factor (preparation, process and outcome) and the seven first-order factor models. Internal consistency was supported by adequate Cronbach's alphas and composite reliability. Convergent and discriminant validities were also supported by confirmatory factor analysis. The study provides evidence that the Simulation Learning Effectiveness Inventory is reliable and valid for measuring student perception of learning effectiveness. The instrument is helpful in building the evidence-based knowledge of the effect of simulation teaching on students' learning outcomes. © 2015 John Wiley & Sons Ltd.

The Drosophila Insulin Receptor Independently Modulates Lifespan and Locomotor Senescence

PubMed Central

Boylan, Michael; Achall, Rajesh; Shirras, Alan; Broughton, Susan J.

2015-01-01

The Insulin/IGF-like signalling (IIS) pathway plays an evolutionarily conserved role in ageing. In model organisms reduced IIS extends lifespan and ameliorates some forms of functional senescence. However, little is known about IIS in nervous system ageing and behavioural senescence. To investigate this role in Drosophila melanogaster, we measured the effect of reduced IIS on senescence of two locomotor behaviours, negative geotaxis and exploratory walking. Two long-lived fly models with systemic IIS reductions (daGAL4/UAS-InRDN (ubiquitous expression of a dominant negative insulin receptor) and d2GAL/UAS-rpr (ablation of insulin-like peptide producing cells)) showed an amelioration of negative geotaxis senescence similar to that previously reported for the long-lived IIS mutant chico. In contrast, exploratory walking in daGAL4/UAS-InRDN and d2GAL/UAS-rpr flies declined with age similarly to controls. To determine the contribution of IIS in the nervous system to these altered senescence patterns and lifespan, the InRDN was targeted to neurons (elavGAL4/UAS-InRDN), which resulted in extension of lifespan in females, normal negative geotaxis senescence in males and females, and detrimental effects on age-specific exploratory walking behaviour in males and females. These data indicate that the Drosophila insulin receptor independently modulates lifespan and age-specific function of different types of locomotor behaviour. The data suggest that ameliorated negative geotaxis senescence of long-lived flies with systemic IIS reductions is due to ageing related effects of reduced IIS outside the nervous system. The lifespan extension and coincident detrimental or neutral effects on locomotor function with a neuron specific reduction (elavGAL4/UAS-InRDN) indicates that reduced IIS is not beneficial to the neural circuitry underlying the behaviours despite increasing lifespan. PMID:26020640

Universe exploration vision

NASA Technical Reports Server (NTRS)

O'Handley, D.; Swan, P.; Sadeh, W.

1992-01-01

U.S. space policy is discussed in terms of present and planned activities in the solar system and beyond to develop a concept for expanding space travel. The history of space exploration is briefly reviewed with references to the Mariner II, Apollo, and Discoverer programs. Attention is given to the issues related to return trips to the moon, sprint vs repetitive missions to Mars, and the implications of propulsion needs. The concept of terraforming other bodies within the solar system so that they can support human activity is identified as the next major phase of exploration. The following phase is considered to be the use of robotic or manned missions that extend beyond the solar system. Reference is given to a proposed Thousand Astronomical Units mission as a precursor to exploratory expansion into the universe, and current robotic mission activities are mentioned.

Developing and piloting a peer mentoring intervention to reduce teenage pregnancy in looked-after children and care leavers: an exploratory randomised controlled trial.

PubMed Central

Mezey, Gillian; Meyer, Deborah; Robinson, Fiona; Bonell, Chris; Campbell, Rona; Gillard, Steve; Jordan, Peter; Mantovani, Nadia; Wellings, Kaye; White, Sarah

2015-01-01

BACKGROUND: Looked-after children (LAC) are at greater risk of teenage pregnancy than non-LAC, which is associated with adverse health and social consequences. Existing interventions have failed to reduce rates of teenage pregnancy in LAC. Peer mentoring is proposed as a means of addressing many of the factors associated with the increased risk of teenage pregnancy in this group. OBJECTIVE: To develop a peer mentoring intervention to reduce teenage pregnancy in LAC. DESIGN: Phase I and II randomised controlled trial of a peer mentoring intervention for LAC; scoping exercise and literature search; national surveys of social care professionals and LAC; and focus groups and interviews with social care professionals, mentors and mentees. SETTING: Three local authorities (LAs) in England. PARTICIPANTS: LAC aged 14-18 years (mentees/care as usual) and 19-25 years (mentors). INTERVENTION: Recruitment and training of mentors; randomisation and matching of mentors to mentees; and 1-year individual peer mentoring. MAIN OUTCOME MEASURES: PRIMARY OUTCOME: pregnancy in LAC aged 14-18 years. SECONDARY OUTCOMES: sexual attitudes, behaviour and knowledge; psychological health; help-seeking behaviour; locus of control; and attachment style. A health economic evaluation was also carried out. RESULTS: In total, 54% of target recruitment was reached for the exploratory trial and 13 out of 20 mentors (65%) and 19 out of 30 LAC aged 14-18 years (63%) (recruited during Phases I and II) were retained in the research. The training programme was acceptable and could be manualised and replicated. Recruitment and retention difficulties were attributed to systemic problems and LA lack of research infrastructure and lack of additional funding to support and sustain such an intervention. Mentees appeared to value the intervention but had difficulty in meeting weekly as required. Only one in four of the relationships continued for the full year. A future Phase III trial would require the intervention to be modified to include provision of group and individual peer mentoring; internal management of the project, with support from an external agency such as a charity or the voluntary sector; funds to cover LA research costs, including the appointment of a dedicated project co-ordinator; a reduction in the lower age for mentee recruitment and an increase in the mentor recruitment age to 21 years; and the introduction of a more formal recruitment and support structure for mentors. CONCLUSIONS: Given the problems identified and described in mounting this intervention, a new development phase followed by a small-scale exploratory trial incorporating these changes would be necessary before proceeding to a Phase III trial. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 85. See the NIHR Journals Library website for further project information. PMID:26497730

Psychometric evaluation of a new instrument in Spanish to measure the wellness of university nursing faculty.

PubMed

Hurtado-Pardos, Barbara; Casas, Irma; Lluch-Canut, Teresa; Moreno-Arroyo, Carmen; Nebot-Bergua, Carlos; Roldán-Merino, Juan

2018-01-02

The aim of this study was to design and validate an instrument to measure the wellness among university nursing faculty. The study was performed in two phases. Phase I consisted of the development of the instrument with discussion groups and participant consensus. We designed an instrument including the 21 items or psychosocial risk factors identified and estimated an index by evaluating the frequency and intensity of each item. The items were grouped into 3 dimensions: teaching work demands, curricular demands, and organizational difficulties. Phase II, we evaluated the psychometric properties of the tool in a sample of 263 participants. Exploratory factor analysis showed a 3-factor structure that explained 53% of the total variance. The internal consistency of the instrument was 0.91 for the whole instrument. The results indicate that the tool developed is valid and reliable and may be a good instrument to monitor the wellness of university nursing faculty.

Optimal cost-effective designs of Phase II proof of concept trials and associated go-no go decisions.

PubMed

Chen, Cong; Beckman, Robert A

2009-01-01

This manuscript discusses optimal cost-effective designs for Phase II proof of concept (PoC) trials. Unlike a confirmatory registration trial, a PoC trial is exploratory in nature, and sponsors of such trials have the liberty to choose the type I error rate and the power. The decision is largely driven by the perceived probability of having a truly active treatment per patient exposure (a surrogate measure to development cost), which is naturally captured in an efficiency score to be defined in this manuscript. Optimization of the score function leads to type I error rate and power (and therefore sample size) for the trial that is most cost-effective. This in turn leads to cost-effective go-no go criteria for development decisions. The idea is applied to derive optimal trial-level, program-level, and franchise-level design strategies. The study is not meant to provide any general conclusion because the settings used are largely simplified for illustrative purposes. However, through the examples provided herein, a reader should be able to gain useful insight into these design problems and apply them to the design of their own PoC trials.

Validation of post-operative residual contrast enhancing tumor volume as an independent prognostic factor for overall survival in newly diagnosed glioblastoma.

PubMed

Ellingson, Benjamin M; Abrey, Lauren E; Nelson, Sarah J; Kaufmann, Timothy J; Garcia, Josep; Chinot, Olivier; Saran, Frank; Nishikawa, Ryo; Henriksson, Roger; Mason, Warren P; Wick, Wolfgang; Butowski, Nicholas; Ligon, Keith L; Gerstner, Elizabeth R; Colman, Howard; de Groot, John; Chang, Susan; Mellinghoff, Ingo; Young, Robert J; Alexander, Brian M; Colen, Rivka; Taylor, Jennie W; Arrillaga-Romany, Isabel; Mehta, Arnav; Huang, Raymond Y; Pope, Whitney B; Reardon, David; Batchelor, Tracy; Prados, Michael; Galanis, Evanthia; Wen, Patrick Y; Cloughesy, Timothy F

2018-04-05

In the current study, we pooled imaging data in newly diagnosed GBM patients from international multicenter clinical trials, single institution databases, and multicenter clinical trial consortiums to identify the relationship between post-operative residual enhancing tumor volume and overall survival (OS). Data from 1,511 newly diagnosed GBM patients from 5 data sources were included in the current study: 1) a single institution database from UCLA (N=398; Discovery); 2) patients from the Ben and Cathy Ivy Foundation for Early Phase Clinical Trials Network Radiogenomics Database (N=262 from 8 centers; Confirmation); 3) the chemoradiation placebo arm from an international phase III trial (AVAglio; N=394 from 120 locations in 23 countries; Validation); 4) the experimental arm from AVAglio examining chemoradiation plus bevacizumab (N=404 from 120 locations in 23 countries; Exploratory Set 1); and 5) an Alliance (N0874) Phase I/II trial of vorinostat plus chemoradiation (N=53; Exploratory Set 2). Post-surgical, residual enhancing disease was quantified using T1 subtraction maps. Multivariate Cox regression models were used to determine influence of clinical variables, MGMT status, and residual tumor volume on OS. A log-linear relationship was observed between post-operative, residual enhancing tumor volume and OS in newly diagnosed GBM treated with standard chemoradiation. Post-operative tumor volume is a prognostic factor for OS (P<0.01), regardless of therapy, age, and MGMT promoter methylation status. Post-surgical, residual contrast-enhancing disease significantly negatively influences survival in patients with newly diagnosed glioblastoma treated with chemoradiation with or without concomitant experimental therapy.

Belatacept-based immunosuppression in de novo liver transplant recipients: 1-year experience from a phase II randomized study.

PubMed

Klintmalm, G B; Feng, S; Lake, J R; Vargas, H E; Wekerle, T; Agnes, S; Brown, K A; Nashan, B; Rostaing, L; Meadows-Shropshire, S; Agarwal, M; Harler, M B; Garcia-Valdecasas, J-C

2014-08-01

This exploratory phase II study evaluated the safety and efficacy of belatacept in de novo adult liver transplant recipients. Patients were randomized (N = 260) to one of the following immunosuppressive regimens: (i) basiliximab + belatacept high dose [HD] + mycophenolate mofetil (MMF), (ii) belatacept HD + MMF, (iii) belatacept low dose [LD] + MMF, (iv) tacrolimus + MMF, or (v) tacrolimus alone. All received corticosteroids. Demographic characteristics were similar among groups. The proportion of patients who met the primary end point (composite of acute rejection, graft loss, death by month 6) was higher in the belatacept groups (42–48%) versus tacrolimus groups (15–38%), with the highest number of deaths and grafts losses in the belatacept LD group. By month 12, the proportion surviving with a functioning graft was higher with tacrolimus + MMF (93%) and lower with belatacept LD (67%) versus other groups (90%: basiliximab + belatacept HD; 83%: belatacept HD; 88%: tacrolimus). Mean calculated GFR was 15–34 mL/min higher in belatacept-treated patients at 1 year. Two cases of posttransplant lymphoproliferative disease and one case of progressive multifocal leukoencephalopathy occurred in belatacept-treated patients. Follow-up beyond month 12 revealed an increase in death and graft loss in another belatacept group (belatacept HD), after which the study was terminated.

Correlation of cetuximab-induced skin rash and outcomes of solid tumor patients treated with cetuximab: a systematic review and meta-analysis.

PubMed

Abdel-Rahman, Omar; Fouad, Mona

2015-02-01

We performed a systematic review and meta-analysis of the correlation between cetuximab-induced skin rash and outcomes of solid tumor patients treated with cetuximab. Eligible studies included phase I, II and III trials of patients with solid tumors on cetuximab; describing events of skin rash and correlating skin rash with overall survival (OS), progression free survival (PFS) and/or overall response rate (ORR). Our search strategy yielded 409 potentially relevant citations on CETUXIMAB from Pubmed/Medline, CENTRAL Cochrane registry and ASCO meeting library. After exclusion of ineligible studies, a total of 13 clinical trials were considered eligible for the meta-analysis, including 4 phase III trials, 8 phase II trials and one phase I trial. The occurrence of cetuximab-induced rash in patients was highly associated with improvements in PFS (HR=0.74; 95% CI: 0.63-0.86, P<0.0002), OS (HR=0.60; 95% CI: 0.47-0.76, P<0.0001), and ORR (RR=1.51, 95% CI: 1.26-1.81, P<0.00001), as compared to patients without rash. Exploratory subgroup analysis showed no effect of tumor types on the RR of ORR. Our meta-analysis has demonstrated that cetuximab-induced rash is associated with a significantly improved OS, PFS and ORR. Cetuximab-induced skin rash may represent a prognostic factor in patients with advanced solid tumors. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Drilling, construction, and aquifer-test data from wells 3-3307-20 and -21, Thompson Corner exploratory wells I and II, Oahu, Hawaii

USGS Publications Warehouse

Presley, T.K.; Oki, D.S.

1996-01-01

The Thompson Corner exploratory wells I and II (State well numbers 3-3307-20 and -21) were drilled near Thompson Corner, about 2.2 miles south-southwest of the town of Haleiwa. The wells are located on agricultural land in the Waialua ground-water area. The wells are about 50 feet apart and penetrate about 90 feet into the ground water. Aquifer tests were conducted using well 3-3307-20 as a pumping well and well 3-3307-21 as an observation well. Well-construction data, logs of drilling notes, geologic descriptions for the samples, and aquifer-test data are presented for the wells. The wells are two of twelve exploratory wells drilled in the north-central Oahu area between July 1993 and May 1994 in cooperation with the Honolulu Board of Water Supply.

Modular Organization of Exploratory Force Development Under Isometric Conditions in the Human Arm.

PubMed

Roh, Jinsook; Lee, Sang Wook; Wilger, Kevin D

2018-01-31

Muscle coordination of isometric force production can be explained by a smaller number of modules. Variability in force output, however, is higher during exploratory/transient force development phases than force maintenance phase, and it is not clear whether the same modular structure underlies both phases. In this study, eight neurologically-intact adults isometrically performed target force matches in 54 directions at hands, and electromyographic (EMG) data from eight muscles were parsed into four sequential phases. Despite the varying degree of motor complexity across phases (significant between-phase differences in EMG-force correlation, angular errors, and between-force correlations), the number/composition of motor modules were found equivalent across phases, suggesting that the CNS systematically modulated activation of the same set of motor modules throughout sequential force development.

Exploratory Factor Analysis of the Beck Anxiety Inventory and the Beck Depression Inventory-II in a Psychiatric Outpatient Population

PubMed Central

2018-01-01

Background To further understand the relationship between anxiety and depression, this study examined the factor structure of the combined items from two validated measures for anxiety and depression. Methods The participants were 406 patients with mixed psychiatric diagnoses including anxiety and depressive disorders from a psychiatric outpatient unit at a university-affiliated medical center. Responses of the Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI)-II, and Symptom Checklist-90-Revised (SCL-90-R) were analyzed. We conducted an exploratory factor analysis of 42 items from the BAI and BDI-II. Correlational analyses were performed between subscale scores of the SCL-90-R and factors derived from the factor analysis. Scores of individual items of the BAI and BDI-II were also compared between groups of anxiety disorder (n = 185) and depressive disorder (n = 123). Results Exploratory factor analysis revealed the following five factors explaining 56.2% of the total variance: somatic anxiety (factor 1), cognitive depression (factor 2), somatic depression (factor 3), subjective anxiety (factor 4), and autonomic anxiety (factor 5). The depression group had significantly higher scores for 12 items on the BDI while the anxiety group demonstrated higher scores for six items on the BAI. Conclusion Our results suggest that anxiety and depressive symptoms as measured by the BAI and BDI-II can be empirically differentiated and that particularly items of the cognitive domain in depression and those of physical domain in anxiety are noteworthy. PMID:29651821

Exploratory Development Research Effectiveness: A Second Evaluation,

DTIC Science & Technology

1978-09-01

A12i 537 EXPLORATORY DEVELOPMENT RESERCH EFFECTIVENESS: A / SECOND EVRLUATfON(U) CALIFORNIA STATE UNIV SACRAMENTO T A BUCKLES ET AL. SEP 78 CSUS/NPS...Administration - CSUS-NPS J077091 ii TABLE OF CONTENTS ABSTRACT . OBJECTIVE.............. . .. .. .. .... 1 DISCUSSION............. .. .. .. .... 1... contention that Work Unit Cost influenced the degree of transition. The last postulate that was tested concerned work unit classification by dollar amount. It

FTY720 and everolimus in de novo renal transplant patients at risk for delayed graft function: results of an exploratory one-yr multicenter study.

PubMed

Tedesco-Silva, H; Lorber, M I; Foster, C E; Sollinger, H W; Mendez, R; Carvalho, D B; Shapiro, R; Rajagopalan, P R; Mayer, H; Slade, J; Kahan, B D

2009-01-01

This exploratory, multicenter, open-label study evaluated the efficacy and safety of FTY720, as a part of an immunosuppressive regimen, in combination with everolimus and steroids in de novo renal transplant recipients at increased risk of delayed graft function (DGF). Patients received FTY720 (5 mg) and everolimus (4 mg) 2-12 h pre-transplantation, followed by 2.5 mg/d FTY720 and concentration-controlled everolimus (4-8 ng/mL) post-transplant for 12 months. Induction therapy was prohibited. After enrollment of 56 of the planned 200 patients between 2000 and 2002, the recruitment was terminated. The primary endpoint, rate of graft loss, or death at three months was 15.4% and the biopsy-confirmed acute rejection was 42.3%. Death or graft loss at 12 months in the DGF and non-DGF arms was 36.0% and 25.9%, respectively. The mean estimated creatinine clearance at three months was 63 and 55 mL/min in the non-DGF and DGF groups, respectively, while at 12 months it was 56 mL/min in both the groups. Although there was no comparator arm, the results from this exploratory study (compared with data from other phases II and III trials) indicated no apparent benefits of FTY720-based regimens for prevention of acute rejection and preservation of renal function in renal transplant recipients at high risk of DGF.

Efficacy and Safety of Artemether in the Treatment of Chronic Fascioliasis in Egypt: Exploratory Phase-2 Trials

PubMed Central

Keiser, Jennifer; Sayed, Hanan; El-Ghanam, Maged; Sabry, Hoda; Anani, Saad; El-Wakeel, Aly; Hatz, Christoph; Utzinger, Jürg; el-Din, Sayed Seif; El-Maadawy, Walaa; Botros, Sanaa

2011-01-01

Background Fascioliasis is an emerging zoonotic disease of considerable veterinary and public health importance. Triclabendazole is the only available drug for treatment. Laboratory studies have documented promising fasciocidal properties of the artemisinins (e.g., artemether). Methodology We carried out two exploratory phase-2 trials to assess the efficacy and safety of oral artemether administered at (i) 6×80 mg over 3 consecutive days, and (ii) 3×200 mg within 24 h in 36 Fasciola-infected individuals in Egypt. Efficacy was determined by cure rate (CR) and egg reduction rate (ERR) based on multiple Kato-Katz thick smears before and after drug administration. Patients who remained Fasciola-positive following artemether dosing were treated with single 10 mg/kg oral triclabendazole. In case of treatment failure, triclabendazole was re-administered at 20 mg/kg in two divided doses. Principal Findings CRs achieved with 6×80 mg and 3×200 mg artemether were 35% and 6%, respectively. The corresponding ERRs were 63% and nil, respectively. Artemether was well tolerated. A high efficacy was observed with triclabendazole administered at 10 mg/kg (16 patients; CR: 67%, ERR: 94%) and 20 mg/kg (4 patients; CR: 75%, ERR: 96%). Conclusions/Significance Artemether, administered at malaria treatment regimens, shows no or only little effect against fascioliasis, and hence does not represent an alternative to triclabendazole. The role of artemether and other artemisinin derivatives as partner drug in combination chemotherapy remains to be elucidated. PMID:21909440

Development of the Sri Lankan early teenagers' violence inventory: an instrument to measure peer violence in schools.

PubMed

Wijeratne, Monika; Seneviratne, Rohini; Gunawardena, Nalika; Østbye, Truls; Lynch, Catherine; Sandøy, Ingvild Fossgard

2014-01-01

This study was designed to develop an inventory to measure peer violence among early teens (13-15 years of age) in schools in Sri Lanka. Development of SLETVI was carried out in two phases. In phase I, development of an operational definition for peer violence, identification, and finalizing violent acts for inventory was done by a combination of qualitative methods: a comprehensive literature review, focus group discussions among 13-15-year-old adolescents, their teachers and parents, and consultative meetings with experts in the field. Inventory was then pretested. In phase II, elaboration of SLETVI was carried out by administering it to a sample of 1700 adolescents (13-15 years old). Exploratory factor analysis using principal component analysis was performed separately for experiences of victimization and perpetration. Test-retest reliability of SLETVI was assessed. SLETVI included 37 items in three factors: "less severe violence," "severe physical," and "severe relational" violence. Combined use of qualitative and quantitative methods enabled development of a culturally valid and reliable operational inventory to assess early teenagers' peer violence in Sri Lankan and other South Asian schools.

Use of frit-disc crucibles for routine and exploratory solution growth of single crystalline samples

DOE PAGES

Canfield, Paul C.; Kong, Tai; Kaluarachchi, Udhara S.; ...

2016-01-05

Solution growth of single crystals from high temperature solutions often involves the separation of residual solution from the grown crystals. For many growths of intermetallic compounds, this separation has historically been achieved with the use of plugs of silica wool. Whereas this is generally efficient in a mechanical sense, it leads to a significant contamination of the decanted liquid with silica fibres. In this paper, we present a simple design for frit-disc alumina crucible sets that has made their use in the growth single crystals from high temperature solutions both simple and affordable. An alumina frit-disc allows for the cleanmore » separation of the residual liquid from the solid phase. This allows for the reuse of the decanted liquid, either for further growth of the same phase, or for subsequent growth of other, related phases. In this article, we provide examples of the growth of isotopically substituted TbCd 6 and icosahedral i-RCd quasicrystals, as well as the separation of (i) the closely related Bi 2Rh 3S 2 and Bi 2Rh 3.5S 2 phases and (ii) and PrZn 11 and PrZn 17.« less

Exploratory Study of RNA Polymerase II Using Dynamic Atomic Force Microscopy

NASA Astrophysics Data System (ADS)

Rhodin, Thor; Umemura, Kazuo; Gad, Mohammed; Jarvis, Suzanne; Ishikawa, Mitsuru; Fu, Jianhua

2002-03-01

An exploratory study of the microtopological dimensions and shape features of yeast RNA polymerase II (y-poly II) on freshly cleaved mica was made in phosphate aqueous buffer solution at room temperature following previous work by Hansma and others. The molecules were imaged by stabilization on freshly cleaved mica at a limiting resolution of 10 Å and scanned using dynamical atomic force microscopy with a 10 nm multi-wall carbon nanotube in the resonance frequency modulation mode. They indicated microtopological shape and dimensional features similar to those predicted by electron density plots derived from the X-ray crystallographic model. It is concluded that this is considered primarily a feasibility study with definitive conclusions subject to more detailed systematic measurements of the 3D microtopology. These measurements appear to establish validity of the noncontact atomic force microscopy (nc-AFM) approach into defining the primary microtopology and biochemical functionality of RNA polymerase II. Further nc-AFM studies at higher resolution using dynamical nc-AFM will be required to clearly define the detailed 3D microtopology of RNA polymerase II in anaerobic aqueous environments for both static and dynamic conditions.

Measuring Adolescent Science Motivation

ERIC Educational Resources Information Center

Schumm, Maximiliane F.; Bogner, Franz X.

2016-01-01

To monitor science motivation, 232 tenth graders of the college preparatory level ("Gymnasium") completed the Science Motivation Questionnaire II (SMQ-II). Additionally, personality data were collected using a 10-item version of the Big Five Inventory. A subsequent exploratory factor analysis based on the eigenvalue-greater-than-one…

Low creatinine clearance is a risk factor for D2 gastrectomy after neoadjuvant chemotherapy.

PubMed

Hayashi, Tsutomu; Aoyama, Toru; Tanabe, Kazuaki; Nishikawa, Kazuhiro; Ito, Yuichi; Ogata, Takashi; Cho, Haruhiko; Morita, Satoshi; Miyashita, Yumi; Tsuburaya, Akira; Sakamoto, Junichi; Yoshikawa, Takaki

2014-09-01

The feasibility and safety of D2 surgery following neoadjuvant chemotherapy (NAC) has not been fully evaluated in patients with gastric cancer. Moreover, risk factor for surgical complications after D2 gastrectomy following NAC is also unknown. The purpose of the present study was to identify risk factors of postoperative complications after D2 surgery following NAC. This study was conducted as an exploratory analysis of a prospective, randomized Phase II trial of NAC. The surgical complications were assessed and classified according to the Clavien-Dindo classification. A uni- and multivariate logistic regression analyses were performed to identify risk factors for morbidity. Among 83 patients who were registered to the Phase II trial, 69 patients received the NAC and D2 gastrectomy. Postoperative complications were identified in 18 patients and the overall morbidity rate was 26.1 %. The results of univariate and multivariate analyses of various factors for overall operative morbidity, creatinine clearance (CCr) ≤ 60 ml/min (P = 0.016) was identified as sole significant independent risk factor for overall morbidity. Occurrence of pancreatic fistula was significantly higher in the patients with a low CCr than in those with a high CCr. Low CCr was a significant risk factor for surgical complications in D2 gastrectomy after NAC. Careful attention is required for these patients.

Using Inquiry Effectively.

ERIC Educational Resources Information Center

Bibens, Robert F.

1980-01-01

The inquiry approach to learning is based on three phases. The exploratory phase encourages students to investigate a particular topic; the invention phase asks students to consider what they have learned; the final phase assists students in discovering the inadequacies of their inventions. (JN)

Exploratory analysis of textual data from the Mother and Child Handbook using a text mining method (II): Monthly changes in the words recorded by mothers.

PubMed

Tagawa, Miki; Matsuda, Yoshio; Manaka, Tomoko; Kobayashi, Makiko; Ohwada, Michitaka; Matsubara, Shigeki

2017-01-01

The aim of the study was to examine the possibility of converting subjective textual data written in the free column space of the Mother and Child Handbook (MCH) into objective information using text mining and to compare any monthly changes in the words written by the mothers. Pregnant women without complications (n = 60) were divided into two groups according to State-Trait Anxiety Inventory grade: low trait anxiety (group I, n = 39) and high trait anxiety (group II, n = 21). Exploratory analysis of the textual data from the MCH was conducted by text mining using the Word Miner software program. Using 1203 structural elements extracted after processing, a comparison of monthly changes in the words used in the mothers' comments was made between the two groups. The data was mainly analyzed by a correspondence analysis. The structural elements in groups I and II were divided into seven and six clusters, respectively, by cluster analysis. Correspondence analysis revealed clear monthly changes in the words used in the mothers' comments as the pregnancy progressed in group I, whereas the association was not clear in group II. The text mining method was useful for exploratory analysis of the textual data obtained from pregnant women, and the monthly change in the words used in the mothers' comments as pregnancy progressed differed according to their degree of unease. © 2016 Japan Society of Obstetrics and Gynecology.

Investigating the Reading-to-Write Processes and Source Use of L2 Postgraduate Students in Real-Life Academic Tasks: An Exploratory Study

ERIC Educational Resources Information Center

McCulloch, Sharon

2013-01-01

Existing studies of source use in academic student writing tend to i), focus more on the writing than the reading end of the reading-to-write continuum and ii), involve the use of insufficiently "naturalistic" writing tasks. Thus, in order to explore the potential of an alternative approach, this paper describes an exploratory case study…

Instructional authoring by direct manipulation of simulations: Exploratory applications of RAPIDS. RAPIDS 2 authoring manual

NASA Technical Reports Server (NTRS)

1990-01-01

RAPIDS II is a simulation-based intelligent tutoring system environment. It is a system for producing computer-based training courses that are built on the foundation of graphical simulations. RAPIDS II simulations can be animated and they can have continuously updating elements.

Psychometric Properties of the Acceptance and Action Questionnaire-II for Chinese College Students and Elite Chinese Athletes

ERIC Educational Resources Information Center

Zhang, Chun-Qing; Chung, Pak-Kwong; Si, Gangyan; Liu, Jing Dong

2014-01-01

The purpose of the present study was to examine the psychometric properties of the Chinese version of the Acceptance and Action Questionnaire-II (AAQ-II) across two samples of Chinese college students (n = 183 and n = 366) and a sample of elite Chinese athletes (n = 330). Exploratory and confirmatory factor analyses supported the existence of a…

Inter-subject phase synchronization for exploratory analysis of task-fMRI.

PubMed

Bolt, Taylor; Nomi, Jason S; Vij, Shruti G; Chang, Catie; Uddin, Lucina Q

2018-08-01

Analysis of task-based fMRI data is conventionally carried out using a hypothesis-driven approach, where blood-oxygen-level dependent (BOLD) time courses are correlated with a hypothesized temporal structure. In some experimental designs, this temporal structure can be difficult to define. In other cases, experimenters may wish to take a more exploratory, data-driven approach to detecting task-driven BOLD activity. In this study, we demonstrate the efficiency and power of an inter-subject synchronization approach for exploratory analysis of task-based fMRI data. Combining the tools of instantaneous phase synchronization and independent component analysis, we characterize whole-brain task-driven responses in terms of group-wise similarity in temporal signal dynamics of brain networks. We applied this framework to fMRI data collected during performance of a simple motor task and a social cognitive task. Analyses using an inter-subject phase synchronization approach revealed a large number of brain networks that dynamically synchronized to various features of the task, often not predicted by the hypothesized temporal structure of the task. We suggest that this methodological framework, along with readily available tools in the fMRI community, provides a powerful exploratory, data-driven approach for analysis of task-driven BOLD activity. Copyright © 2018 Elsevier Inc. All rights reserved.

CECs and IL-8 Have Prognostic and Predictive Utility in Patients with Recurrent Platinum-Sensitive Ovarian Cancer: Biomarker Correlates from the Randomized Phase-2 Trial of Olaparib and Cediranib Compared with Olaparib in Recurrent Platinum-Sensitive Ovarian Cancer.

PubMed

Lee, Jung-Min; Trepel, Jane B; Choyke, Peter; Cao, Liang; Sissung, Tristan; Houston, Nicole; Yu, Minshu; Figg, William D; Turkbey, Ismail Baris; Steinberg, Seth M; Lee, Min-Jung; Ivy, S Percy; Liu, Joyce F; Matulonis, Ursula A; Kohn, Elise C

2015-01-01

Olaparib (O), a polyADPribose polymerase (PARP) inhibitor, and cediranib (C), a VEGF receptor (VEGFR)1-3 inhibitor together had greater activity than O alone in women with recurrent platinum-sensitive ovarian cancer (OvCa). The objective of this study is to identify potential lead biomarker candidates for response to O + C in the setting of a multi-institutional phase II study of O with and without C in recurrent platinum-sensitive OvCa. A self-selected group of patients participated in a prospectively planned exploratory biomarker substudy of the randomized phase II study of O versus O + C. Whole blood for peripheral blood mononuclear cell (PBMC) and plasma isolation was collected prior to and on day 3 of treatment. Quantitation of circulating endothelial cells (CEC), IL-6, IL-8, VEGF, and soluble VEGFR-2 plasma concentrations, and polyADPribose (PAR) incorporation were performed. Single nucleotide polymorphism analysis of XRCC1 280H, R194W, and Q399R was done. Dynamic contrast-enhanced-magnetic resonance imaging (DCE-MRI) was performed at baseline and day 3 of treatment. Parameter changes were compared between the two arms using an exact Wilcoxon rank sum test. Kaplan-Meier and log-rank tests were used to examine survival outcome. Thirteen patients elected to participate in the translational substudy, seven patients on O and six patients on O + C. Patients on O + C had a greater decrease in IL-8 concentration and larger CEC fold increase compared with those on O alone (p = 0.026, p = 0.032). The fold increase in CEC on day 3 was associated with duration of progression-free survival (PFS) (R (2) = 0.77, 95% CI 0.55-0.97, p < 0.001). IL-8 post-pretreatment changes correlate with PFS (p = 0.028). XRCC1 DNA polymorphisms were not related to PFS. All patients had reduction in PAR incorporation, and all except one had reduction in vascular flow on DCE-MRI. Our exploratory correlative studies indicate that CEC and IL-8 changes may be predictive for response to O + C and prognostic in recurrent platinum-sensitive OvCa, requiring prospective validation.

A phase I study of muscadine grape skin extract in men with biochemically recurrent prostate cancer: Safety, tolerability, and dose determination.

PubMed

Paller, Channing J; Rudek, Michelle A; Zhou, Xian C; Wagner, William D; Hudson, Tamaro S; Anders, Nicole; Hammers, Hans J; Dowling, Donna; King, Serina; Antonarakis, Emmanuel S; Drake, Charles G; Eisenberger, Mario A; Denmeade, Samuel R; Rosner, Gary L; Carducci, Michael A

2015-10-01

New therapies are being explored as therapeutic options for men with biochemically recurrent prostate cancer (BRPC) who wish to defer androgen deprivation therapy. MPX is pulverized muscadine grape (Vitis rotundifolia) skin that contains ellagic acid, quercetin, and resveratrol and demonstrates preclinical activity against prostate cancer cells in vitro. In the phase I portion of this phase I/II study, non-metastatic BRPC patients were assigned to increasing doses of MPX (Muscadine Naturals. Inc., Clemmons, NC) in cohorts of two patients, with six patients at the highest dose, using a modified continual reassessment method. Initial dose selection was based on preclinical data showing the equivalent of 500 to 4,000 mg of MPX to be safe in mouse models. The primary endpoint was the recommended phase II dosing regimen. The cohort (n = 14, 71% Caucasian, 29% black) had a median follow-up of 19.2 (6.2-29.7) months, median age of 61 years, and median Gleason score of 7. Four patients had possibly related gastrointestinal symptoms, including grade 1 flatulence, grade 1 soft stools, and grade 1 eructation. No other related adverse events were reported and one patient reported improvement of chronic constipation. Six of 14 patients came off study for disease progression (five metastatic, one rising PSA) after exposure for a median of 15 months. One patient came off for myasthenia gravis that was unrelated to treatment. Seven patients remain on study. The lack of dose-limiting toxicities led to the selection of 4,000 mg/d as the highest dose for further study. Median within-patient PSADT increased by 5.3 months (non-significant, P = 0.17). No patients experienced a maintained decline in serum PSA from baseline. These data suggest that 4,000 mg of MPX is safe, and exploratory review of a lengthening in PSADT of a median of 5.3 months supports further exploration of MPX. Both low-dose (500 mg) and high-dose (4,000 mg) MPX are being further investigated in a randomized, multicenter, placebo-controlled, dose-evaluating phase II trial. © 2015 Wiley Periodicals, Inc.

US NDC Modernization Iteration E2 Prototyping Report: User Interface Framework

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lewis, Jennifer E.; Palmer, Melanie A.; Vickers, James Wallace

2014-12-01

During the second iteration of the US NDC Modernization Elaboration phase (E2), the SNL US NDC Modernization project team completed follow-on Rich Client Platform (RCP) exploratory prototyping related to the User Interface Framework (UIF). The team also developed a survey of browser-based User Interface solutions and completed exploratory prototyping for selected solutions. This report presents the results of the browser-based UI survey, summarizes the E2 browser-based UI and RCP prototyping work, and outlines a path forward for the third iteration of the Elaboration phase (E3).

Design innovations and baseline findings in a long-term Parkinson's trial: the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease Long-Term Study-1.

PubMed

Elm, Jordan J

2012-10-01

Based on the preclinical data and the results of a phase II futility study, creatine was selected for an efficacy trial in Parkinson's disease (PD). We present the design rationale and a description of the study cohort at baseline. A randomized, multicenter, double-blind, parallel-group, placebo-controlled phase III study of creatine (10 g daily) in participants with early, treated PD, the Long-term Study-1 (LS-1), is being conducted by the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease network. The study utilizes a global statistical test (GST) encompassing five clinical rating scales to provide a multidimensional assessment of disease progression. A total of 1,741 PD participants from 45 sites in the United States and Canada were randomized 1:1 to either 10 g of creatine/day or matching placebo. Participants are being evaluated for a minimum of 5 years. The LS-1 baseline cohort includes participants treated with dopaminergic therapy and generally mild PD. LS-1 represents the largest cohort of patients with early treated PD ever enrolled in a clinical trial. The GST approach should provide high power to test the hypothesis that daily administration of creatine (10 g/day) is more effective than placebo in slowing clinical decline in PD between baseline and the 5-year follow-up visit against the background of dopaminergic therapy and best PD care. Copyright © 2012 Movement Disorder Society.

Development of a Comprehensive Heart Disease Knowledge Questionnaire

PubMed Central

Bergman, Hannah E.; Reeve, Bryce B.; Moser, Richard P.; Scholl, Sarah; Klein, William M. P.

2011-01-01

Background Heart disease is the number one killer of both men and women in the United States, yet a comprehensive and evidence-based heart disease knowledge assessment is currently not available. Purpose This paper describes the 2 phase development of a novel heart disease knowledge questionnaire. Methods After review and critique of the existing literature, a questionnaire addressing 5 central domains of heart disease knowledge was constructed. In Phase I, 606 undergraduates completed a 82-item questionnaire. In Phase II, 248 undergraduates completed a revised 74-item questionnaire. In both phases, item clarity and difficulty were evaluated, along with the overall factor structure of the scale. Results Exploratory and confirmatory factor analyses were used to reduce the scale to 30 items with fit statistics, CFI = .82, TLI = .88, and RMSEA = .03. Scores were correlated moderately positively with an existing scale and weakly positively with a measure of health literacy, thereby establishing both convergent and divergent validity. Discussion The finalized 30-item questionnaire is a concise, yet discriminating instrument that reliably measures participants' heart disease knowledge levels. Translation to Health Education Practice Health professionals can use this scale to assess their patients' heart disease knowledge so that they can create a tailored program to help their patients reduce their heart disease risk. PMID:21720571

"Barriers to Cognitive Behavioral Therapy Homework Completion Scale- Depression Version": Development and Psychometric Evaluation.

PubMed

Callan, Judith A; Dunbar-Jacob, Jacqueline; Sereika, Susan M; Stone, Clement; Fasiczka, Amy; Jarrett, Robin B; Thase, Michael E

2012-01-01

We conducted a two-phase study to develop and evaluate the psychometric properties of an instrument to identify barriers to Cognitive Behavioral Therapy (CBT) homework completion in a depressed sample. In Phase I, we developed an item pool by interviewing 20 depressed patients and 20 CBT therapists. In Phase II, we created and administered a draft instrument to 56 people with depression. Exploratory Factor Analysis revealed a 2-factor oblique solution of "Patient Factors" and "Therapy/Task Factors." Internal consistency coefficients ranged from .80 to .95. Temporal stability was demonstrated through Pearson correlations of .72 (for the therapist/task subscale) to .95 (for the patient subscale) over periods of time that ranged from 2 days to 3 weeks. The patient subscale was able to satisfactorily classify patients (75 to 79 %) with low and high adherence at both sessions. Specificity was .66 at both time points. Sensitivity was .80 at sessions B and .77 at session C. There were no consistent predictors of assignment compliance when measured by the Assignment Compliance Rating Scale (Primakoff, Epstein, & Covi, 1986). The Rating Scale and subscale scores did, however, correlate significantly with assignment non-compliance (.32 to .46).

“Barriers to Cognitive Behavioral Therapy Homework Completion Scale- Depression Version”: Development and Psychometric Evaluation

PubMed Central

Callan, Judith A.; Dunbar-Jacob, Jacqueline; Sereika, Susan M.; Stone, Clement; Fasiczka, Amy; Jarrett, Robin B.; Thase, Michael E.

2013-01-01

We conducted a two-phase study to develop and evaluate the psychometric properties of an instrument to identify barriers to Cognitive Behavioral Therapy (CBT) homework completion in a depressed sample. In Phase I, we developed an item pool by interviewing 20 depressed patients and 20 CBT therapists. In Phase II, we created and administered a draft instrument to 56 people with depression. Exploratory Factor Analysis revealed a 2-factor oblique solution of “Patient Factors” and “Therapy/Task Factors.” Internal consistency coefficients ranged from .80 to .95. Temporal stability was demonstrated through Pearson correlations of .72 (for the therapist/task subscale) to .95 (for the patient subscale) over periods of time that ranged from 2 days to 3 weeks. The patient subscale was able to satisfactorily classify patients (75 to 79 %) with low and high adherence at both sessions. Specificity was .66 at both time points. Sensitivity was .80 at sessions B and .77 at session C. There were no consistent predictors of assignment compliance when measured by the Assignment Compliance Rating Scale (Primakoff, Epstein, & Covi, 1986). The Rating Scale and subscale scores did, however, correlate significantly with assignment non-compliance (.32 to .46). PMID:24049556

Development of the Sri Lankan Early Teenagers' Violence Inventory: An Instrument to Measure Peer Violence in Schools

PubMed Central

Seneviratne, Rohini; Østbye, Truls; Lynch, Catherine; Sandøy, Ingvild Fossgard

2014-01-01

This study was designed to develop an inventory to measure peer violence among early teens (13–15 years of age) in schools in Sri Lanka. Development of SLETVI was carried out in two phases. In phase I, development of an operational definition for peer violence, identification, and finalizing violent acts for inventory was done by a combination of qualitative methods: a comprehensive literature review, focus group discussions among 13–15-year-old adolescents, their teachers and parents, and consultative meetings with experts in the field. Inventory was then pretested. In phase II, elaboration of SLETVI was carried out by administering it to a sample of 1700 adolescents (13–15 years old). Exploratory factor analysis using principal component analysis was performed separately for experiences of victimization and perpetration. Test-retest reliability of SLETVI was assessed. SLETVI included 37 items in three factors: “less severe violence,” “severe physical,” and “severe relational” violence. Combined use of qualitative and quantitative methods enabled development of a culturally valid and reliable operational inventory to assess early teenagers' peer violence in Sri Lankan and other South Asian schools. PMID:25061607

Phase II study of biweekly plitidepsin as second-line therapy for advanced or metastatic transitional cell carcinoma of the urothelium.

PubMed

Dumez, Herlinde; Gallardo, Enrique; Culine, Stephane; Galceran, Joan Carles; Schöffski, Patrick; Droz, Jean P; Extremera, Sonia; Szyldergemajn, Sergio; Fléchon, Aude

2009-09-16

The objective of this exploratory, open-label, single-arm, phase II clinical trial was to evaluate plitidepsin (5 mg/m(2)) administered as a 3-hour continuous intravenous infusion every two weeks to patients with locally advanced/metastatic transitional cell carcinoma of the urothelium who relapsed/progressed after first-line chemotherapy. Treatment cycles were repeated for up to 12 cycles or until disease progression, unacceptable toxicity, patient refusal or treatment delay for >2 weeks. The primary efficacy endpoint was objective response rate according to RECIST. Secondary endpoints were the rate of SD lasting > or = 6 months and time-to-event variables. Toxicity was assessed using NCI-CTC v. 3.0. Twenty-one patients received 57 treatment cycles. No objective tumor responses occurred. SD lasting <6 months was observed in two of 18 evaluable patients. With a median follow-up of 4.6 months, the median PFR and the median OS were 1.4 months and 2.3 months, respectively. The most common AEs were mild to moderate nausea, fatigue, myalgia and anorexia. Anemia, lymphopenia, and increases in transaminases, alkaline phosphatase and creatinine were the most frequent laboratory abnormalities. No severe neutropenia occurred. Treatment was feasible and generally well tolerated in this patient population; however the lack of antitumor activity precludes further studies of plitidepsin in this setting.

Fixed dose darunavir boosted with cobicistat combined with emtricitabine and tenofovir alafenamide fumarate.

PubMed

Cevik, Muge; Orkin, Chloe

2018-07-01

In an era when virological efficacy approaches 100%, novel antiretroviral (ARV) therapies must deliver better tolerability, safety, and convenient coformulated regimens. We review the phase II and III clinical data on the fixed dose combination (FDC) darunavir (DRV) 800mg / cobicistat (COBI/C) 150 mg / emtricitabine (F/FTC) 200 mg / tenofovir alafenamide fumarate (TAF) 10mg (D/C/F/TAF) for the treatment of HIV-1 infection. In an exploratory phase II study, D/C/F/TAF FDC demonstrated similar virological efficacy to darunavir/cobicistat FDC + F /tenofovir disoproxil fumarate (TDF) FDC in treatment-naive HIV-1-infected individuals with favorable bone and renal outcomes. These findings led to two subsequent international phase III double-blind randomized controlled trials; AMBER and EMERALD. In the (treatment naïve) AMBER study, D/C/F/TAF FDC was noninferior to component regimen F/TDF + darunavir/cobicistat with favorable bone and renal outcomes at week 48. In the EMERALD study (switch study for virologically suppressed patients), D/C/F/TAF showed noninferior efficacy to F/TDF and boosted protease inhibitor (bPI) regimen at week 48 also with favorable renal and bone outcomes. No virological failure was observed, and no resistance to TDF or darunavir emerged in either study. In clinical trials, D/C/F/TAF FDC demonstrated excellent, noninferior virological efficacy, maintained a high genetic barrier and conferred the additional safety benefits of TAF. As the first one pill, once daily, protease inhibitor-based regimen, D/C/F/TAF FDC offers a new option for the treatment of HIV infection.

HUMEX, a study on the survivability and adaptation of humans to long-duration exploratory missions, part II: Missions to Mars

NASA Astrophysics Data System (ADS)

Horneck, G.; Facius, R.; Reichert, M.; Rettberg, P.; Seboldt, W.; Manzey, D.; Comet, B.; Maillet, A.; Preiss, H.; Schauer, L.; Dussap, C. G.; Poughon, L.; Belyavin, A.; Reitz, G.; Baumstark-Khan, C.; Gerzer, R.

2006-01-01

Space exploration programmes, currently under discussion in the US and in Europe, foresee human missions to Mars to happen within the first half of this century. In this context, the European Space Agency (ESA) has conducted a study on the human responses, limits and needs for such exploratory missions, the so-called HUMEX study (ESA SP-1264). Based on a critical assessment of the limiting factors for human health and performance and the definition of the life science and life support requirements performed in the frame of the HUMEX study, the following major critical items have been identified: (i) radiation health risks, mainly occurring during the interplanetary transfer phases and severely augmented in case of an eruption of a solar particle event; (ii) health risks caused by extended periods in microgravity with an unacceptable risk of bone fracture as a consequence of bone demineralisation; (iii) psychological risks as a consequence of long-term isolation and confinement in an environment so far not experienced by humans; (iv) the requirement of bioregenerative life support systems complementary to physico-chemical systems, and of in situ resource utilisation to reach a closure of the life support system to the highest degree possible. Considering these constraints, it has been concluded that substantial research and development activities are required in order to provide the basic information for appropriate integrated risk managements, including efficient countermeasures and tailored life support. Methodological approaches should include research on the ISS, on robotic precursors missions to Mars, in ground-based simulation facilities as well as in analogue natural environments on Earth.

Development and psychometric evaluation of the Premarital Sexual Behavior Assessment Scale for Young Women (PSAS-YW): an exploratory mixed method study.

PubMed

Rahmani, Azam; Merghati-Khoei, Effat; Moghadam-Banaem, Lida; Hajizadeh, Ebrahim; Hamdieh, Mostafa; Montazeri, Ali

2014-06-13

Premarital sexual behaviors are important issue for women's health. The present study was designed to develop and examine the psychometric properties of a scale in order to identify young women who are at greater risk of premarital sexual behavior. This was an exploratory mixed method investigation. Indeed, the study was conducted in two phases. In the first phase, qualitative methods (focus group discussion and individual interview) were applied to generate items and develop the questionnaire. In the second phase, psychometric properties (validity and reliability) of the questionnaire were assessed. In the first phase an item pool containing 53 statements related to premarital sexual behavior was generated. In the second phase item reduction was applied and the final version of the questionnaire containing 26 items was developed. The psychometric properties of this final version were assessed and the results showed that the instrument has a good structure, and reliability. The results from exploratory factory analysis indicated a 5-factor solution for the instrument that jointly accounted for the 57.4% of variance observed. The Cronbach's alpha coefficient for the instrument was found to be 0.87. This study provided a valid and reliable scale to identify premarital sexual behavior in young women. Assessment of premarital sexual behavior might help to improve women's sexual abstinence.

Development and psychometric evaluation of the Premarital Sexual Behavior Assessment Scale for Young Women (PSAS-YW): an exploratory mixed method study

PubMed Central

2014-01-01

Background Premarital sexual behaviors are important issue for women’s health. The present study was designed to develop and examine the psychometric properties of a scale in order to identify young women who are at greater risk of premarital sexual behavior. Method This was an exploratory mixed method investigation. Indeed, the study was conducted in two phases. In the first phase, qualitative methods (focus group discussion and individual interview) were applied to generate items and develop the questionnaire. In the second phase, psychometric properties (validity and reliability) of the questionnaire were assessed. Results In the first phase an item pool containing 53 statements related to premarital sexual behavior was generated. In the second phase item reduction was applied and the final version of the questionnaire containing 26 items was developed. The psychometric properties of this final version were assessed and the results showed that the instrument has a good structure, and reliability. The results from exploratory factory analysis indicated a 5-factor solution for the instrument that jointly accounted for the 57.4% of variance observed. The Cronbach’s alpha coefficient for the instrument was found to be 0.87. Conclusion This study provided a valid and reliable scale to identify premarital sexual behavior in young women. Assessment of premarital sexual behavior might help to improve women’s sexual abstinence. PMID:24924696

Life in the Middle: An Exploratory Study of California Community College Instructional Deans

ERIC Educational Resources Information Center

Sill, Nancy

2014-01-01

This two-phase sequential mixed methods exploratory study examined the perceived skill deficits of instructional deans at California community colleges to better understand the training and development needs that are necessary to support dean success and to prepare them for advancement in a timelier manner. This study is grounded in the…

Beowawe Geothermal Area evaluation program. Final report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Iovenitti, J. L

Several exploration programs were conducted at the Beowawe Geothermal Prospect, Lander and Eureka County, Nevada. Part I, consisting of a shallow temperature hole program, a mercury soil sampling survey, and a self-potential survey were conducted in order to select the optimum site for an exploratory well. Part II consisted of drilling a 5927-foot exploratory well, running geophysical logs, conducting a drill stem test (2937-3208 feet), and a short-term (3-day) flow test (1655-2188 feet). All basic data collected is summarized.

Osimertinib in Pretreated T790M-Positive Advanced Non-Small-Cell Lung Cancer: AURA Study Phase II Extension Component.

PubMed

Yang, James Chih-Hsin; Ahn, Myung-Ju; Kim, Dong-Wan; Ramalingam, Suresh S; Sequist, Lecia V; Su, Wu-Chou; Kim, Sang-We; Kim, Joo-Hang; Planchard, David; Felip, Enriqueta; Blackhall, Fiona; Haggstrom, Daniel; Yoh, Kiyotaka; Novello, Silvia; Gold, Kathryn; Hirashima, Tomonori; Lin, Chia-Chi; Mann, Helen; Cantarini, Mireille; Ghiorghiu, Serban; Jänne, Pasi A

2017-04-20

Purpose Osimertinib is an irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) selective for both EGFR-TKI sensitizing ( EGFRm) and T790M resistance mutations. AURA (NCT01802632) is a phase I/II clinical trial to determine the dose, safety, and efficacy of osimertinib. This article reports the results from the phase II extension component. Patients and Methods Patients with EGFR-TKI-pretreated EGFRm- and T790M-positive advanced non-small-cell lung cancer (NSCLC) received once-daily osimertinib 80 mg. T790M status was confirmed by central testing from a tumor sample taken after the most recent disease progression. Patients with asymptomatic, stable CNS metastases that did not require corticosteroids were allowed to enroll. The primary end point was objective response rate (ORR) by independent radiology assessment. Secondary end points were disease control rate, duration of response, progression-free survival (PFS), and safety. Patient-reported outcomes comprised an exploratory objective. Results In total, 201 patients received treatment, with a median treatment duration of 13.2 months at the time of data cutoff (November 1, 2015). In evaluable patients (n = 198), ORR was 62% (95% CI, 54% to 68%), and the disease control rate was 90% (95% CI, 85 to 94). Median duration of response in 122 responding patients was 15.2 months (95% CI, 11.3 to not calculable). Median PFS was 12.3 months (95% CI, 9.5 to 13.8). The most common possibly causally related adverse events (investigator assessed) were diarrhea (43%; grade ≥ 3, < 1%) and rash (grouped terms; 40%; grade ≥ 3, < 1%). Interstitial lung disease (grouped terms) was reported in eight patients (4%; grade 1, n = 2; grade 3, n = 3; grade 5, n = 3). Conclusion In patients with EGFRm T790M advanced NSCLC who progress after EGFR-TKI treatment, osimertinib provides a high ORR, encouraging PFS, and durable response.

Randomized Phase II, Double-Blind, Placebo-Controlled Study of Exemestane With or Without Entinostat in Postmenopausal Women With Locally Recurrent or Metastatic Estrogen Receptor-Positive Breast Cancer Progressing on Treatment With a Nonsteroidal Aromatase Inhibitor

PubMed Central

Yardley, Denise A.; Ismail-Khan, Roohi R.; Melichar, Bohuslav; Lichinitser, Mikhail; Munster, Pamela N.; Klein, Pamela M.; Cruickshank, Scott; Miller, Kathy D.; Lee, Min J.; Trepel, Jane B

2013-01-01

Purpose Entinostat is an oral isoform selective histone deacetylase inhibitor that targets resistance to hormonal therapies in estrogen receptor–positive (ER+) breast cancer. This randomized, placebo-controlled, phase II study evaluated entinostat combined with the aromatase inhibitor exemestane versus exemestane alone. Patients and Methods Postmenopausal women with ER+ advanced breast cancer progressing on a nonsteroidal aromatase inhibitor were randomly assigned to exemestane 25 mg daily plus entinostat 5 mg once per week (EE) or exemestane plus placebo (EP). The primary end point was progression-free survival (PFS). Blood was collected in a subset of patients for evaluation of protein lysine acetylation as a biomarker of entinostat activity. Results One hundred thirty patients were randomly assigned (EE group, n = 64; EP group, n = 66). Based on intent-to-treat analysis, treatment with EE improved median PFS to 4.3 months versus 2.3 months with EP (hazard ratio [HR], 0.73; 95% CI, 0.50 to 1.07; one-sided P = .055; two-sided P = .11 [predefined significance level of .10, one-sided]). Median overall survival was an exploratory end point and improved to 28.1 months with EE versus 19.8 months with EP (HR, 0.59; 95% CI, 0.36 to 0.97; P = .036). Fatigue and neutropenia were the most frequent grade 3/4 toxicities. Treatment discontinuation because of adverse events was higher in the EE group versus the EP group (11% v 2%). Protein lysine hyperacetylation in the EE biomarker subset was associated with prolonged PFS. Conclusion Entinostat added to exemestane is generally well tolerated and demonstrated activity in patients with ER+ advanced breast cancer in this signal-finding phase II study. Acetylation changes may provide an opportunity to maximize clinical benefit with entinostat. Plans for a confirmatory study are underway. PMID:23650416

Isotopic differentiation and sublattice melting in dense dynamic ice

NASA Astrophysics Data System (ADS)

Hermann, Andreas; Ashcroft, N. W.; Hoffmann, Roald

2013-12-01

The isotopes of hydrogen provide a unique exploratory laboratory for examining the role of zero point energy (ZPE) in determining the structural and dynamic features of the crystalline ices of water. There are two critical regions of high pressure: (i) near 1 TPa and (ii) near the predicted onset of metallization at around 5 TPa. At the lower pressure of the two, we see the expected small isotopic effects on phase transitions. Near metallization, however, the effects are much greater, leading to a situation where tritiated ice could skip almost entirely a phase available to the other isotopomers. For the higher pressure ices, we investigate in some detail the enthalpics of a dynamic proton sublattice, with the corresponding structures being quite ionic. The resistance toward diffusion of single protons in the ground state structures of high-pressure H2O is found to be large, in fact to the point that the ZPE reservoir cannot overcome these. However, the barriers toward a three-dimensional coherent or concerted motion of protons can be much lower, and the ensuing consequences are explored.

More than a Library?: Urban Poverty and an Exploratory Look at the Role of a Neighborhood Institution

ERIC Educational Resources Information Center

Ly, Carolyn

2010-01-01

Libraries have traditionally tended to be one of the few institutionally provided public resources for local residents in poor, urban, neighborhoods. This paper presents findings from the exploratory phase of an ongoing research project which examines, through participant observation, the "value" of a public library in a poor urban neighborhood.…

ADVANCED COMBUSTION SYSTEMS FOR STATIONARY GAS TURBINE ENGINES: VOLUME I. REVIEW AND PRELIMINARY EVALUATION

EPA Science Inventory

The reports describe an exploratory development program to identify, evaluate, and demonstrate dry techniques for significantly reducing NOx from thermal and fuel-bound sources in stationary gas turbine engines. Volume 1 covers Phase I of the four-phase effort. In Phase I, duty c...

Seven Deadly Sins of Childhood: Advising Parents about Difficult Developmental Phases.

ERIC Educational Resources Information Center

Schmitt, Barton D.

1987-01-01

Seven difficult developmental phases for parents are colic, awakening at night, separation anxiety, normal exploratory behavior, normal negativism, normal poor appetite, and toilet training resistance. Principles of behavior modification and alternatives to physical punishment are given for each phase as part of the treatment plan for the…

Phase 1 drilling operations at the Magma Energy Exploratory Well (LVF 51-20)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Finger, J.T.; Jacobson, R.D.

1990-12-01

This report describes the Phase 1 drilling operations for the Magma Energy Exploratory Well near Mammoth Lakes, California. An important part of the Department of Energy's Magma Energy Program, this well is designed to reach an ultimate depth of 20,000 feet or a bottomhole temperature of 500{degree}C, whichever comes first. There will be four drilling phases, at least a year apart, with scientific investigations in the borehole between the drilling intervals. Phase 1 of this project resulted in a 20 inch cased hole to 2558 feet, with 185 feet of coring beyond that. This document comprises a narrative of themore » daily activities, copies of the daily mud and lithologic reports, time breakdowns of rig activities, inventories of lost circulation materials, temperature logs of the cored hole, and a strip chart mud log. 2 figs.« less

A Gynecologic Oncology Group phase II trial of the protein kinase C-beta inhibitor, enzastaurin and evaluation of markers with potential predictive and prognostic value in persistent or recurrent epithelial ovarian and primary peritoneal malignancies

PubMed Central

Usha, Lydia; Sill, Michael W.; Darcy, Kathleen M.; Benbrook, Doris M.; Hurteau, Jean A; Michelin, David P.; Mannel, Robert S.; Hanjani, Parviz; De Geest, Koen; Godwin, Andrew K.

2011-01-01

Purpose Protein kinase C (PKC) activation contributes to proliferation and angiogenesis in epithelial ovarian or primary peritoneal carcinoma (EOC/PPC). A multi-institutional phase II trial was conducted to evaluate the efficacy and safety of PKCβ inhibitor enzastaurin in persistent or recurrent EOC/PPC and to explore potential prognostic and predictive biomarkers. Methods Eligible women with measurable platinum-sensitive and resistant EOC/PPC were treated with continuous administration of oral enzastaurin until disease progression or unacceptable toxicity. A two-stage sequential design was used to evaluate progression-free survival (PFS) ≥ 6-months, tumor response, and toxicity. Translational studies included sequencing of the TP53, PTEN, PIK3CA and PKCβII genes for somatic mutations, quantitative PCR assays for AKT2 and PTEN copy number alterations, and measurement of circulating VEGF-A plasma levels. Results Among 27 eligible and evaluable patients, 3 women with PFS ≥ 6-months (11%) and 2 women with partial responses (7%) were observed. One of them achieved a durable response and remains on the study. No grade 4 adverse events were observed. Most common grade 3 adverse events were constitutional (4) and gastrointestinal (3). Mutations in the TP53 gene and abnormal copy number in the PTEN gene were common (56% and 48% of cases, respectively). Conclusions Enzastaurin was tolerable but had insufficient activity to proceed with the second stage of accrual. However, 1 patient has been progression-free for 44 months. No association between a biomarker and response to enzastaurin has been found. Exploratory analysis suggested an association between survival and PTEN copy number losses. PMID:21414654

Healthy subjects volunteering for Phase I studies: influence of curiosity, exploratory tendencies and perceived self-efficacy.

PubMed

Almeida, L; Kashdan, T B; Coelho, R; Albino-Teixeira, A; Soares-da-Silva, P

2008-03-01

To test the hypothesis that trait-curiosity and perceived self-efficacy influence the willingness of healthy subjects to volunteer for participation in Phase I studies. A group of healthy subjects who had never participated in clinical studies ("index group") were invited to participate in a Phase I study. They were assessed with regard to trait curiosity (Curiosity and Exploration Inventory; CEI-T) and perceived self-efficacy (Self-Efficacy Scale; SES) and subjects who accepted the invitation to participate were compared with those who refused and with a group of healthy subjects who had previously participated in clinical studies ("validation group"). A significant positive correlation was found between the willingness to participate and the CEI-T total score (R=0.28; p<0.01), exploratory tendencies (R=0.34; p<0.001), SES total score (R=0.30, p<0.01), initiative and persistence (R=0.29, p<0.01), planning/goal setting (R=0.19, p<0.05) and social self-efficacy (R=0.29; p<0.01). The "index group" subjects who accepted the invitation to participate showed significantly greater CEI-T exploratory tendencies (Z=-3.334, p = 0.001, Mann-Whitney test) and total scores (Z=-2.703, p<0.01) and greater SES total score (Z=-3.131, p<0.01), initiative and persistence (Z=-3.065, p<0.01), planning/goal setting (Z=-2.173, p<0.05) and social self-efficacy (Z=-2.954, p<0.01) than subjects who refused. No differences were found between the subjects in the "index group" who accepted the invitation and subjects in the "validation group". Using a logistic regression model, both CEI-T exploratory tendencies and SES initiative/persistence were significant predictors of participation. Subjects higher in curiosity/exploration and in perceived initiative/persistence are more willing to volunteer for Phase I studies. The impact of these self-selection biases on Phase I study results is unknown but deserves further evaluation.

Gastric dilatation and volvulus in a brachycephalic dog with hiatal hernia.

PubMed

Aslanian, M E; Sharp, C R; Garneau, M S

2014-10-01

A brachycephalic dog was presented with an acute onset of retching and abdominal discomfort. The dog had a chronic history of stertor and exercise intolerance suggestive of brachycephalic airway obstructive syndrome. Radiographs were consistent with a Type II hiatal hernia. The dog was referred and within hours of admission became acutely painful and developed tympanic abdominal distension. A right lateral abdominal radiograph confirmed gastric dilatation and volvulus with herniation of the pylorus through the hiatus. An emergency exploratory coeliotomy was performed, during which the stomach was derotated, and an incisional gastropexy, herniorrhaphy and splenectomy were performed. A staphylectomy was performed immediately following the exploratory coeliotomy. The dog recovered uneventfully. Gastric dilatation and volvulus is a potentially life-threatening complication that can occur in dogs with Type II hiatal hernia and should be considered a surgical emergency. © 2014 British Small Animal Veterinary Association.

An Exploratory Study of Specific Factors in a Prison Environment That Affect a Manpower Training Project.

ERIC Educational Resources Information Center

Barton, Marlin C.; And Others

An exploratory study of a prison community is presented. The study employed a three-phase design: (1) a pre-survey of the prison community, (2) limited intervention, based on findings of the pre-survey, and (3) a post-survey to determine effects of intervention and to validate findings of the pre-survey for which no intervention had been designed.…

Focusing on What Counts: Using Exploratory Focus Groups to Enhance the Development of an Electronic Survey in a Mixed-Methods Research Design

ERIC Educational Resources Information Center

Galliott, Natal'ya; Graham, Linda J.

2016-01-01

This paper illustrates the use of exploratory focus groups to inform the development of a survey instrument in a sequential phase mixed-methods study investigating differences in secondary students' career choice capability. Five focus groups were conducted with 23 Year 10 students in the state of New South Wales, Australia. Analysis of the focus…

An Exploratory Study of Informal Learning and Team Performance in the Pre-Consulting Phase

ERIC Educational Resources Information Center

Sibarani, Roza Marsaulina

2014-01-01

This paper reports the process of informal learning in the pre-consulting phase in management-consulting firms in Indonesia. As the consulting industry significantly grows in Indonesia, more organisations use consultant services to improve their business. Pre-consulting is an important phase to define the right solutions, which involves a lot of…

ROC curves in clinical chemistry: uses, misuses, and possible solutions.

PubMed

Obuchowski, Nancy A; Lieber, Michael L; Wians, Frank H

2004-07-01

ROC curves have become the standard for describing and comparing the accuracy of diagnostic tests. Not surprisingly, ROC curves are used often by clinical chemists. Our aims were to observe how the accuracy of clinical laboratory diagnostic tests is assessed, compared, and reported in the literature; to identify common problems with the use of ROC curves; and to offer some possible solutions. We reviewed every original work using ROC curves and published in Clinical Chemistry in 2001 or 2002. For each article we recorded phase of the research, prospective or retrospective design, sample size, presence/absence of confidence intervals (CIs), nature of the statistical analysis, and major analysis problems. Of 58 articles, 31% were phase I (exploratory), 50% were phase II (challenge), and 19% were phase III (advanced) studies. The studies increased in sample size from phase I to III and showed a progression in the use of prospective designs. Most phase I studies were powered to assess diagnostic tests with ROC areas >/=0.70. Thirty-eight percent of studies failed to include CIs for diagnostic test accuracy or the CIs were constructed inappropriately. Thirty-three percent of studies provided insufficient analysis for comparing diagnostic tests. Other problems included dichotomization of the gold standard scale and inappropriate analysis of the equivalence of two diagnostic tests. We identify available software and make some suggestions for sample size determination, testing for equivalence in diagnostic accuracy, and alternatives to a dichotomous classification of a continuous-scale gold standard. More methodologic research is needed in areas specific to clinical chemistry.

Patient-Centered Communication: Exploring the Dentist's Role in the Era of e-Patients and Health 2.0.

PubMed

Seymour, Brittany; Yang, Helen; Getman, Rebekah; Barrow, Jane; Kalenderian, Elsbeth

2016-06-01

In today's digital era, people are increasingly relying on the Internet-including social media-to access health information and inform their health decisions. This article describes an exploratory initiative to better understand and define the role of dentists in patient education in the context of e-patients and Health 2.0. This initiative consisted of four phases. In Phase I, an interdisciplinary expert advisory committee was assembled for a roundtable discussion about patients' health information-seeking behaviors online. In Phase II, a pilot case study was conducted, with methods and analysis informed by Phase I recommendations. Phase III consisted of a debriefing conference to outline future areas of research on modernizing health communication strategies. In Phase IV, the findings and working theories were presented to 75 dental students, who then took a survey regarding their perspectives with the objective of guiding potential curriculum design for predoctoral courses. The results of the survey showed that the validity of online content was often secondary to the strength of the network sharing it and that advocacy online could be more effective if it allowed for emotional connections with peers rather than preserving accuracy of the information. Students expressed high interest in learning how to harness modern health communications in their clinical care since the role of the dentist is evolving from giving information to giving personalized guidance against the backdrop of an often contradictory modern information environment. The authors recommend that the dental profession develop patient-centered health communication training for predoctoral students and professional development and continuing education for practicing professionals.

An exploratory sequential design to validate measures of moral emotions.

PubMed

Márquez, Margarita G; Delgado, Ana R

2017-05-01

This paper presents an exploratory and sequential mixed methods approach in validating measures of knowledge of the moral emotions of contempt, anger and disgust. The sample comprised 60 participants in the qualitative phase when a measurement instrument was designed. Item stems, response options and correction keys were planned following the results obtained in a descriptive phenomenological analysis of the interviews. In the quantitative phase, the scale was used with a sample of 102 Spanish participants, and the results were analysed with the Rasch model. In the qualitative phase, salient themes included reasons, objects and action tendencies. In the quantitative phase, good psychometric properties were obtained. The model fit was adequate. However, some changes had to be made to the scale in order to improve the proportion of variance explained. Substantive and methodological im-plications of this mixed-methods study are discussed. Had the study used a single re-search method in isolation, aspects of the global understanding of contempt, anger and disgust would have been lost.

Further development of the talent development environment questionnaire for sport.

PubMed

Li, Chunxiao; Wang, Chee Keng John; Pyun, Do Young; Martindale, Russell

2015-01-01

Given the significance of monitoring the critical environmental factors that facilitate athlete performance, this two-phase research aimed to validate and refine the revised talent development environment questionnaire (TDEQ). The TDEQ is a multidimensional self-report scale that assesses talented athletes' environmental experiences. Study 1 (the first phase) involved the examination of the revised TDEQ through an exploratory factor analysis (n = 363). This exploratory investigation identified a 28-item five-factor structure (i.e., TDEQ-5) with adequate internal consistency. Study 2 (the second phase) examined the factorial structure of the TDEQ-5, including convergent validity, discriminant validity, and group invariance (i.e., gender and sports type). The second phase was carried out with 496 talented athletes through the application of confirmatory factor analyses and multigroup invariance tests. The results supported the convergent validity, discriminant validity, and group invariance of the TDEQ-5. In conclusion, the TDEQ-5 with 25 items appears to be a reliable and valid scale for use in talent development environments.

The dynamics of migration-related stress and coping of female domestic workers from the Philippines: an exploratory study.

PubMed

van der Ham, Alida Joanna; Ujano-Batangan, Maria Theresa; Ignacio, Raquel; Wolffers, Ivan

2015-01-01

Female domestic workers face many migration-related stressors that affect their mental health, but we know little about the dynamics of stress and coping in different migration phases. This exploratory study aims to assess stress and coping of female migrant domestic workers from the Philippines in different phases of the migration process; prior to migration, in the country of destination and upon return to the Philippines. Data were collected in 2010 using questionnaires (N = 500). Validation of findings took place in a work shop (23 participants) and two focus groups (13 and 8 participants). Stress levels of women were significantly higher abroad than in the Philippines. Stress and coping in the Philippines was primarily related to financial issues, while stress and coping abroad related more strongly loneliness, working conditions and employers. Findings from this study provide insight in the phase-specific and transnational dimensions of stress and coping.

Influence of environmental enrichment vs. time-of-day on behavioral repertoire of male albino Swiss mice.

PubMed

Loss, Cássio Morais; Binder, Luisa Bandeira; Muccini, Eduarda; Martins, Wagner Carbolin; de Oliveira, Paulo Alexandre; Vandresen-Filho, Samuel; Prediger, Rui Daniel; Tasca, Carla Inês; Zimmer, Eduardo R; Costa-Schmidt, Luiz Ernesto; de Oliveira, Diogo Losch; Viola, Giordano Gubert

2015-11-01

Environmental enrichment (EE) is a non-pharmacological manipulation that promotes diverse forms of benefits in the central nervous system of captive animals. It is thought that EE influences animal behavior in a specie-(strain)-specific manner. Since rodents in general present different behaviors during distinct periods of the day, in this study we aimed to investigate the influence of time-of-day on behavioral repertoire of Swiss mice that reared in EE. Forty male Swiss mice (21days old) were housed in standard (SC) or enriched conditions (EC) for 60days. Behavioral assessments were conducted during the light phase (in presence of light) or dark phase (in absence of light) in the following tasks: open field, object recognition and elevated plus maze. First, we observed that the locomotor and exploratory activities are distinct between SC and EC groups only during the light phase. Second, we observed that "self-protective behaviors" were increased in EC group only when mice were tested during the light phase. However, "less defensive behaviors" were not affected by both housing conditions and time-of-day. Third, we showed that the performance of EE animals in object recognition task was improved in both light and dark conditions. Our findings highlight that EE-induced alterations in exploratory and emotional behaviors are just evident during light conditions. However, EE-induced cognitive benefits are remarkable even during dark conditions, when exploratory and emotional behaviors were similar between groups. Copyright © 2015 Elsevier Inc. All rights reserved.

Small Business Innovation Research GRC Phase I, Phase II, and Post-Phase II Opportunity Assessment for 2015

NASA Technical Reports Server (NTRS)

Nguyen, Hung D.; Steele, Gynelle C.

2016-01-01

This report outlines the 2015 Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) Phase I, Phase II, and Post-Phase II opportunity contract award results associated with NASA's Aeronautics Research Mission Directorate (ARMD), Human Exploration and Operations Mission Directorate (HEOMD), Science Mission Directorate (SMD), and Space Technology Mission Directorate (STMD) for NASA Glenn Research Center. The report also highlights the number of Phase I, Phase II, and Post-Phase II contracts awarded by mission directorate. The 2015 Phase I contract awards to companies in Ohio and their corresponding technologies are also discussed.

Validation of the World Health Organization Disability Assessment Schedule (WHO-DAS II) in Greek and its added value to the Short Form 36 (SF-36) in a sample of people with or without disabilities.

PubMed

Xenouli, Georgia; Xenoulis, Kostis; Sarafis, Pavlos; Niakas, Dimitris; Alexopoulos, Evangelos C

2016-07-01

There is controversy and ongoing interest on the measurement of functionality in the personal and social level. (1) to validate the Greek version of the World Health Organization Disability Assessment Schedule (WHO DAS II) and (2) to determine its added value to the physical and psychological health subscales of the Short Form 36 (SF-36). In a cross-sectional design, data were collected between December 2014 and March 2015 by using three questionnaires (WHO DAS II, SF-36, PSS-14) in a sample of people with disabilities (n = 101) and without disabilities (n = 109) in Athens, Greece. WHO DAS II internal consistency, construct and criterion-related validity were assessed by Cronbach alpha, exploratory factor analysis and correlations; its added value by multivariable linear regression. Cronbach Alpha's were satisfactory for the WHO DAS II, PSS-14 and SF-36 (0.85, 0.88 and 0.96 respectively). Exploratory factor analysis confirmed the existence of one or two factors in people with or without disabilities, respectively. WHO DAS II score showed significant negative correlation with the physical and mental health scale of SF-36 score, especially strong for physical health while was positively related to PSS-14 score. In multivariate analysis mental health appraisal was related to perceived stress in both groups. This study support the validity of the Greek version of WHO DAS II and warranted its use in assessment and follow up of people with disabilities, contributing to the development of suitable policies to cover their needs and providing comparable data with other surveys using the same instrument. Copyright © 2016 Elsevier Inc. All rights reserved.

A phase II study of axitinib (AG-013736) in patients with incurable adenoid cystic carcinoma.

PubMed

Ho, A L; Dunn, L; Sherman, E J; Fury, M G; Baxi, S S; Chandramohan, R; Dogan, S; Morris, L G T; Cullen, G D; Haque, S; Sima, C S; Ni, A; Antonescu, C R; Katabi, N; Pfister, D G

2016-10-01

Recurrent/metastatic adenoid cystic carcinoma (ACC) is an incurable disease with no standard treatments. The majority of ACCs express the oncogenic transcription factor MYB (also c-myb), often in the context of a MYB gene rearrangement. This phase II trial of the tyrosine kinase inhibitor (TKI) axitinib (Pfizer) tested the hypothesis that targeting pathways activated by MYB can be therapeutically effective for ACC. This is a minimax two-stage, phase II trial that enrolled patients with incurable ACC of any primary site. Progressive or symptomatic disease was required. Patients were treated with axitinib 5 mg oral twice daily; dose escalation was allowed. The primary end point was best overall response (BOR). An exploratory analysis correlating biomarkers to drug benefit was conducted, including next-generation sequencing (NGS) in 11 patients. Thirty-three patients were registered and evaluable for response. Fifteen patients had the axitinib dose increased. Tumor shrinkage was achieved in 22 (66.7%); 3 (9.1%) had confirmed partial responses. Twenty-five (75.8%) patients had stable disease, 10 of whom had disease stability for >6 months. The median progression-free survival (PFS) was 5.7 months (range 0.92-21.8 months). Grade 3 axitinib-related toxicities included hypertension, oral pain and fatigue. A trend toward superior PFS was noted with the MYB/NFIB rearrangement, although this was not statistically significant. NGS revealed three tumors with 4q12 amplification, producing increased copies of axitinib-targeted genes PDGFR/KDR/KIT. Two 4q12 amplified patients achieved stable disease for >6 months, including one with significant tumor reduction and the longest PFS on study (21.8 months). Although the primary end point was not met, axitinib exhibited clinical activity with tumor shrinkage achieved in the majority of patients with progressive disease before trial enrollment. Analysis of MYB biomarkers and genomic profiling suggests the hypothesis that 4q12 amplified ACCs are a disease subset that benefit from TKI therapy. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Analysis of phase II studies on targeted agents and subsequent phase III trials: what are the predictors for success?

PubMed

Chan, John K; Ueda, Stefanie M; Sugiyama, Valerie E; Stave, Christopher D; Shin, Jacob Y; Monk, Bradley J; Sikic, Branimir I; Osann, Kathryn; Kapp, Daniel S

2008-03-20

To identify the characteristics of phase II studies that predict for subsequent "positive" phase III trials (those that reached the proposed primary end points of study or those wherein the study drug was superior to the standard regimen investigating targeted agents in advanced tumors. We identified all phase III clinical trials of targeted therapies against advanced cancers published from 1985 to 2005. Characteristics of the preceding phase II studies were reviewed to identify predictive factors for success of the subsequent phase III trial. Data were analyzed using the chi(2) test and logistic regression models. Of 351 phase II studies, 167 (47.6%) subsequent phase III trials were positive and 184 (52.4%) negative. Phase II studies from multiple rather than single institutions were more likely to precede a successful trial (60.4% v 39.4%; P < .001). Positive phase II results were more likely to lead to a successful phase III trial (50.8% v 22.5%; P = .003). The percentage of successful trials from pharmaceutical companies was significantly higher compared with academic, cooperative groups, and research institutes (89.5% v 44.2%, 45.2%, and 46.3%, respectively; P = .002). On multivariate analysis, these factors and shorter time interval between publication of phase II results and III study publication were independent predictive factors for a positive phase III trial. In phase II studies of targeted agents, multiple- versus single-institution participation, positive phase II trial, pharmaceutical company-based trials, and shorter time period between publication of phase II to phase III trial were independent predictive factors of success in a phase III trial. Investigators should be cognizant of these factors in phase II studies before designing phase III trials.

A protocol for an exploratory phase I mixed-methods study of enhanced integrated care for care home residents with advanced dementia: the Compassion Intervention.

PubMed

Elliott, Margaret; Harrington, Jane; Moore, Kirsten; Davis, Sarah; Kupeli, Nuriye; Vickerstaff, Victoria; Gola, Anna; Candy, Bridget; Sampson, Elizabeth L; Jones, Louise

2014-06-17

In the UK approximately 700,000 people are living with, and a third of people aged over 65 will die with, dementia. People with dementia may receive poor quality care towards the end of life. We applied a realist approach and used mixed methods to develop a complex intervention to improve care for people with advanced dementia and their family carers. Consensus on intervention content was achieved using the RAND UCLA appropriateness method and mapped to sociological theories of process and impact. Core components are: (1) facilitation of integrated care, (2) education, training and support, (3) investment from commissioners and care providers. We present the protocol for an exploratory phase I study to implement components 1 and 2 in order to understand how the intervention operates in practice and to assess feasibility and acceptability. An 'Interdisciplinary Care Leader (ICL)' will work within two care homes, alongside staff and associated professionals to facilitate service integration, encourage structured needs assessment, develop the use of personal and advance care plans and support staff training. We will use qualitative and quantitative methods to collect data for a range of outcome and process measures to detect effects on individual residents, family carers, care home staff, the intervention team, the interdisciplinary team and wider systems. Analysis will include descriptive statistics summarising process and care home level data, individual demographic and clinical characteristics and data on symptom burden, clinical events and quality of care. Qualitative data will be explored using thematic analysis. Findings will inform a future phase II trial. Ethical approval was granted (REC reference 14/LO/0370). We shall publish findings at conferences, in peer-reviewed journals, on the Marie Curie Cancer Care website and prepare reports for dissemination by organisations involved with end-of-life care and dementia. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Oral ELND005 (scyllo-Inositol) in Young Adults with Down Syndrome without Dementia.

PubMed

Rafii, Michael S; Skotko, Brian G; McDonough, Mary Ellen; Pulsifer, Margaret; Evans, Casey; Doran, Eric; Muranevici, Gabriela; Kesslak, Patrick; Abushakra, Susan; Lott, Ira T

2017-01-01

ELND005 (scyllo-Inositol; cyclohexane-1,2,3,4,5,6-hexol) has been evaluated as a potential disease-modifying treatment for Alzheimer's disease (AD). Individuals with Down syndrome (DS) have an increased risk for developing AD dementia. To evaluate the safety and tolerability of ELND005 and to determine its pharmacokinetics (PK) and relationship between PK parameters, safety outcome measures, and exploratory efficacy outcome measures in young adults with DS without dementia. This was a prospective, randomized, double-blind, placebo-controlled, parallel-group, three-arm, multicenter Phase II study of the safety and pharmacokinetics of ELND005 administered orally for 4 weeks (ClinicalTrials.gov NCT01791725). Participants who met study eligibility criteria were randomly assigned in a 2 : 1:1 ratio to receive ELND005 at either 250 mg twice daily (BID) or 250 mg once daily (QD) or matching placebo for 4 weeks. There were no apparent treatment group-related trends on cognitive or behavioral measures and there were no SAEs and no deaths in the study. Overall, mean changes from baseline in clinical laboratory parameters, vital sign measurements, electrocardiogram results, and other physical findings were unremarkable. ELND005 accumulation averaged approximately 2-fold with QD dosing, and 3- to 4-fold with BID dosing. Overall, treatment of adults with DS with ELND005 at both doses was well tolerated, achieved measurable blood levels and demonstrated no safety findings. Further studies will be needed to test efficacy.

Forebrain-Specific Loss of BMPRII in Mice Reduces Anxiety and Increases Object Exploration.

PubMed

McBrayer, Zofeyah L; Dimova, Jiva; Pisansky, Marc T; Sun, Mu; Beppu, Hideyuki; Gewirtz, Jonathan C; O'Connor, Michael B

2015-01-01

To investigate the role of Bone Morphogenic Protein Receptor Type II (BMPRII) in learning, memory, and exploratory behavior in mice, a tissue-specific knockout of BMPRII in the post-natal hippocampus and forebrain was generated. We found that BMPRII mutant mice had normal spatial learning and memory in the Morris water maze, but showed significantly reduced swimming speeds with increased floating behavior. Further analysis using the Porsolt Swim Test to investigate behavioral despair did not reveal any differences in immobility between mutants and controls. In the Elevated Plus Maze, BMPRII mutants and Smad4 mutants showed reduced anxiety, while in exploratory tests, BMPRII mutants showed more interest in object exploration. These results suggest that loss of BMPRII in the mouse hippocampus and forebrain does not disrupt spatial learning and memory encoding, but instead impacts exploratory and anxiety-related behaviors.

Forebrain-Specific Loss of BMPRII in Mice Reduces Anxiety and Increases Object Exploration

PubMed Central

McBrayer, Zofeyah L.; Dimova, Jiva; Pisansky, Marc T.; Sun, Mu; Beppu, Hideyuki; Gewirtz, Jonathan C.; O’Connor, Michael B.

2015-01-01

To investigate the role of Bone Morphogenic Protein Receptor Type II (BMPRII) in learning, memory, and exploratory behavior in mice, a tissue-specific knockout of BMPRII in the post-natal hippocampus and forebrain was generated. We found that BMPRII mutant mice had normal spatial learning and memory in the Morris water maze, but showed significantly reduced swimming speeds with increased floating behavior. Further analysis using the Porsolt Swim Test to investigate behavioral despair did not reveal any differences in immobility between mutants and controls. In the Elevated Plus Maze, BMPRII mutants and Smad4 mutants showed reduced anxiety, while in exploratory tests, BMPRII mutants showed more interest in object exploration. These results suggest that loss of BMPRII in the mouse hippocampus and forebrain does not disrupt spatial learning and memory encoding, but instead impacts exploratory and anxiety-related behaviors. PMID:26444546

Development and validation of a five-factor sexual satisfaction and distress scale for women: the Sexual Satisfaction Scale for Women (SSS-W).

PubMed

Meston, Cindy; Trapnell, Paul

2005-01-01

This article presents data based on the responses of over 800 women who contributed to the development of the Sexual Satisfaction Scale for Women (SSS-W). The aim of this study was to develop a comprehensive, multifaceted, valid, and reliable self-report measure of women's sexual satisfaction and distress. Phase I involved the initial selection of items based on past literature and on interviews of women diagnosed with sexual dysfunction and an exploratory factor analysis. Phase II involved an additional administration of the questionnaire, factor analyses, and refinement of the questionnaire items. Phase III involved administration of the final questionnaire to a sample of women with clinically diagnosed sexual dysfunction and controls. Psychometric evaluation of the SSS-W conducted in a sample of women meeting DSM-IV-TR criteria for female sexual dysfunction and in a control sample provided preliminary evidence of reliability and validity. The ability of the SSS-W to discriminate between sexually functional and dysfunctional women was demonstrated for each of the SSS-W domain scores and total score. The SSS-W is a brief, 30-item measure of sexual satisfaction and sexual distress, composed of five domains supported by factor analyses: contentment, communication, compatibility, relational concern, and personal concern. It exhibits sound psychometric properties and has a demonstrated ability to discriminate between clinical and nonclinical samples.

Psychometric properties of the Dutch version of the London Measure of Unplanned Pregnancy in women with pregnancies ending in birth.

PubMed

Goossens, Joline; Verhaeghe, Sofie; Van Hecke, Ann; Barrett, Geraldine; Delbaere, Ilse; Beeckman, Dimitri

2018-01-01

To evaluate the psychometric properties of the Dutch version of the London Measure of Unplanned Pregnancy in women with pregnancies ending in birth. A two-phase psychometric evaluation design was set-up. Phase I comprised the translation from English into Dutch and pretesting with 6 women using cognitive interviews. In phase II, the reliability and validity of the Dutch version of the LMUP was assessed in 517 women giving birth recently. Reliability (internal consistency) was assessed using Cronbach's alpha, inter-item correlations, and corrected item-total correlations. Construct validity was assessed using principal components analysis and hypothesis testing. Exploratory Mokken scale analysis was carried out. 517 women aged 15-45 completed the Dutch version of the LMUP. Reliability testing showed acceptable internal consistency (alpha = 0.74, positive inter-item correlations between all items, all corrected item-total correlations >0.20). Validity testing confirmed the unidimensional structure of the scale and all hypotheses were confirmed. The overall Loevinger's H coefficient was 0.57, representing a 'strong' scale. The Dutch version of the LMUP is a reliable and valid measure that can be used in the Dutch-speaking population in Belgium to assess pregnancy planning. Future research is necessary to assess the stability of the Dutch version of the LMUP, and to evaluate its psychometric properties in women with abortions.

77 FR 3771 - Notice of Issuance of Final Outer Continental Shelf Air Permit for Shell Offshore, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-25

... drilling vessels (the Transocean Deepwater Nautilus, the Noble Bully I or the Noble Bully II) and support vessels to conduct exploratory drilling for up to 150 days per year over five to ten years in multiple...

Exploratory study of hot-in-place recycling of asphalt pavements, volume II : appendices.

DOT National Transportation Integrated Search

1994-11-01

Hot-in-place recycling (HIR) is a method for rehabilitation of asphalt pavements. Potential for cost savings and resource preservation are high because existing pavement materials are processed on-site, with only the addition of small amounts of recy...

Nrf2-related gene expression and exposure to traffic-related air pollution in elderly subjects with cardiovascular disease: An exploratory panel study

PubMed Central

Wittkopp, Sharine; Staimer, Norbert; Tjoa, Thomas; Stinchcombe, Timothy; Daher, Nancy; Schauer, James J.; Shafer, Martin M.; Sioutas, Constantinos; Gillen, Daniel L.; Delfino, Ralph J.

2015-01-01

Gene expression changes are linked to air pollutant exposures in in vitro and animal experiments. However, limited data are available on how these outcomes relate to ambient air pollutant exposures in humans. We performed an exploratory analysis testing whether gene expression levels were associated with air pollution exposures in a Los Angeles area cohort of elderly subjects with coronary artery disease. Candidate genes (35) were selected from published studies of gene expression-pollutant associations. Expression levels were measured weekly in 43 subjects (≤12 weeks) using quantitative PCR. Exposures included gaseous pollutants O3, nitrogen oxides (NOx), and CO; particulate matter (PM) pollutants elemental and black carbon (EC, BC); and size-fractionated PM mass. We measured organic compounds from PM filter extracts, including polycyclic aromatic hydrocarbons (PAHs), and determined the in vitro oxidative potential of particle extracts. Associations between exposures and gene expression levels were analyzed using mixed-effects regression models. We found positive associations of traffic-related pollutants (EC, BC, primary organic carbon, PM0.25-2.5 PAH and/or PM0.25 PAH, and NOx) with NFE2L2, Nrf2-mediated genes (HMOX1, NQO1, and SOD2), CYP1B1, IL1B, and SELP. Findings suggest that NFE2L2 gene expression links associations of traffic-related air pollution with phase I and II enzyme genes at the promoter transcription level. PMID:25564368

Nrf2-related gene expression and exposure to traffic-related air pollution in elderly subjects with cardiovascular disease: An exploratory panel study.

PubMed

Wittkopp, Sharine; Staimer, Norbert; Tjoa, Thomas; Stinchcombe, Timothy; Daher, Nancy; Schauer, James J; Shafer, Martin M; Sioutas, Constantinos; Gillen, Daniel L; Delfino, Ralph J

2016-01-01

Gene expression changes are linked to air pollutant exposures in in vitro and animal experiments. However, limited data are available on how these outcomes relate to ambient air pollutant exposures in humans. We performed an exploratory analysis testing whether gene expression levels were associated with air pollution exposures in a Los Angeles area cohort of elderly subjects with coronary artery disease. Candidate genes (35) were selected from published studies of gene expression-pollutant associations. Expression levels were measured weekly in 43 subjects (≤ 12 weeks) using quantitative PCR. Exposures included gaseous pollutants O3, nitrogen oxides (NOx), and CO; particulate matter (PM) pollutants elemental and black carbon (EC, BC); and size-fractionated PM mass. We measured organic compounds from PM filter extracts, including polycyclic aromatic hydrocarbons (PAHs), and determined the in vitro oxidative potential of particle extracts. Associations between exposures and gene expression levels were analyzed using mixed-effects regression models. We found positive associations of traffic-related pollutants (EC, BC, primary organic carbon, PM 0.25-2.5 PAH and/or PM 0.25 PAH, and NOx) with NFE2L2, Nrf2-mediated genes (HMOX1, NQO1, and SOD2), CYP1B1, IL1B, and SELP. Findings suggest that NFE2L2 gene expression links associations of traffic-related air pollution with phase I and II enzyme genes at the promoter transcription level.

Development and Preliminary Validation of the Collective Efficacy Questionnaire for Sports

ERIC Educational Resources Information Center

Short, Sandra E.; Sullivan, Philip; Feltz, Deborah L.

2005-01-01

This study presents the development and preliminary validation of the Collective Efficacy Questionnaire for Sports (CEQS). The study was conducted in 3 phases. In Phase 1, a 42-item questionnaire was developed and tested with 271 college-aged student-athletes. An exploratory factor analysis revealed 5 collective efficacy factors with 27 items…

Study of CETA Plans and Reservation Economic Development. Executive Summary.

ERIC Educational Resources Information Center

Fazio, Ernest J., Jr.; Kelly, Patricia F.

Field study and analysis of program documents were undertaken in the first phase of a multi-phased research effort to improve and strengthen the relationships between CETA programs and economic development activities on Indian reservations. Exploratory in nature, the study examined the approaches developed by 24 Indian reservations and Native…

The Obstacles for the Teaching of 8th Grade TR History of Revolution and Kemalism Course According to the Constructivist Approach (An Example of Exploratory Sequential Mixed Method Design)

ERIC Educational Resources Information Center

Karademir, Yavuz; Demir, Selcuk Besir

2015-01-01

The aim of this study is to ascertain the problems social studies teachers face in the teaching of topics covered in 8th grade TRHRK Course. The study was conducted in line with explanatory sequential mixed method design, which is one of the mixed research method, was used. The study involves three phases. In the first step, exploratory process…

Electric power generation using geothermal brine resources for a proof of concept facility

NASA Technical Reports Server (NTRS)

Hankin, J. W.

1974-01-01

An exploratory systems study of a geothermal proof-of-concept facility is being conducted. This study is the initial phase (Phase 0) of a project to establish the technical and economic feasibility of using hot brine resources for electric power production and other industrial applications. Phase 0 includes the conceptual design of an experimental test-bed facility and a 10-MWe power generating facility.

A phase 2 trial of dasatinib in patients with locally advanced or stage IV mucosal, acral, or vulvovaginal melanoma: A trial of the ECOG-ACRIN Cancer Research Group (E2607).

PubMed

Kalinsky, Kevin; Lee, Sandra; Rubin, Krista M; Lawrence, Donald P; Iafrarte, Anthony J; Borger, Darell R; Margolin, Kim A; Leitao, Mario M; Tarhini, Ahmad A; Koon, Henry B; Pecora, Andrew L; Jaslowski, Anthony J; Cohen, Gary I; Kuzel, Timothy M; Lao, Christopher D; Kirkwood, John M

2017-07-15

KIT-directed tyrosine kinase inhibitors such as imatinib have demonstrated benefits in KIT-mutant (KIT+) mucosal, acral, vulvovaginal, and chronically sun-damaged (CSD) melanoma. Dasatinib has superior preclinical activity in comparison with other tyrosine kinase inhibitors against cells with the most common KIT mutation, exon 11 L576P . The ECOG-ACRIN E2607 trial assessed dasatinib in patients with these melanoma subtypes. Patients received 70 mg of oral dasatinib twice daily. The primary objective for this 2-stage phase 2 trial was response rate. Stage I was open to KIT+ and wild-type KIT (KIT-) mucosal, acral, and CSD melanoma (n = 57). Stage II accrued only KIT+ tumors (n = 30). To enrich the trial for KIT+ tumors, vulvovaginal melanoma was added, and CSD melanoma was removed from eligibility. Secondary objectives included progression-free survival (PFS), overall survival (OS), and safety. From May 2009 to December 2010, the first stage enrolled 57 patients. Among the evaluable patients, 3 of 51 (5.9%) achieved a partial response: all were KIT-. Stage II closed early because of slow accrual (November 2011 to December 2015). In stage II, 4 of 22 evaluable patients (18.2%) had a partial response; the median duration was 4.2 months. The median PFS was 2.1 months (n = 73; 95% confidence interval [CI], 1.5-2.9 months). The median OS was 7.5 months (95% CI, 6.0-11.9 months). In exploratory analyses, no differences were seen in PFS or OS with the KIT status or subtype. Dasatinib was discontinued because of adverse events in 9 of 75 patients (12%). The dasatinib response rate among KIT+ melanoma patients was low. In view of its clinical activity, it is recommended that imatinib remain the KIT tyrosine kinase inhibitor of choice for unresectable KIT+ melanoma. Cancer 2017;123:2688-97. © 2017 American Cancer Society. © 2017 American Cancer Society.

[Design and validation of a scale to assess Latin American medical students' perception on the labour of the first level of health care].

PubMed

Mayta-Tristán, Percy; Mezones-Holguín, Edward; Pereyra-Elías, Reneé; Montenegro-Idrogo, Juan J; Mejia, Christian R; Dulanto-Pizzorni, Andrés; Muñoz, Sergio R

2013-04-01

To design and validate a scale to assess Latin American medical students' perception on first level of health care (FLHC). An observational, analytic and multicentre study was carried out in two phases: i) A self-administered questionnaire regarding perceptions on FLHClabor was designed. ii) This questionnaire was applied to to medical students from 18 universities of eight Spanish-speaking Latin American countries. An exploratory factor analysis (EFA) was performed through a principal components analysis with orthogonal varimax rotation. Sample adequacy was evaluated. Factor extraction was based on Kaiser's criteria, Cattell's Scree test and the explained variance (>5%). Internal consistency was measured with Cronbach's alpha. 423 students were included in the analysis; 53.4% were from Peruvian universities. After the EFA, the questionnaire conserved 11 items, which were distributed in three domains, that explaining together 55.47% of the total variance: i) Perceptions concerning the FLHC physician; ii) Perceptions concerning the FiLC labor and iii) Perceptions about the economic consequences of working in FLHC. The scale is composed by three domains and can be used to assess the perceptions of the medical work on first level of health care of Spanish-speaking Latin American medical students.

Further Refinements in the Measurement of Exercise Imagery: The Exercise Imagery Inventory

ERIC Educational Resources Information Center

Giacobbi, Peter R., Jr.; Hausenblas, Heather A.; Penfield, Randall D.

2005-01-01

The factorial and construct validity of the Exercise Imagery Inventory (EII) were assessed with 3 separate samples of participants. In Phase 1, a 41-item measure was administered to 504 undergraduate students. Exploratory factor analysis supported a 4-factor model that explained 65% of the variance. In Phase 2, a 19-item measure was administered…

Establishment of a New School and an Innovative School: Lessons from Two Israeli Case Studies

ERIC Educational Resources Information Center

Tubin, Dorit

2008-01-01

Purpose: The paper aims to explore the stages involved in the school establishment phase and detect differences between new and innovative schools startup. Design/methodology/approach: The exploratory study was conducted on the creation phase of two Israeli elementary schools: one new and one innovative. The data were collected through interviews…

"Sounds of Intent", Phase 2: Gauging the Music Development of Children with Complex Needs

ERIC Educational Resources Information Center

Ockelford, A.; Welch, G.; Jewell-Gore, L.; Cheng, E.; Vogiatzoglou, A.; Himonides, E.

2011-01-01

This article reports the latest phase of research in the "Sounds of intent" project, which is seeking, as a long-term goal, to map musical development in children and young people with severe, or profound and multiple learning difficulties (SLD or PMLD). Previous exploratory work had resulted in a framework of six putative…

The Use of Published Clinical Study Reports to Support U.S. Food and Drug Administration Approval of Imaging Agents.

PubMed

Rieves, Dwaine; Jacobs, Paula

2016-12-01

Pharmaceutical companies typically perform prospective, multicenter phase 3 clinical studies to support approval of a new imaging agent by the U.S. Food and Drug Administration (FDA). In uncommon situations, the FDA has approved imaging agents based solely, or in large part, on the clinical study experience described in published reports, including reports of exploratory (i.e., phase 1 or 2) studies performed at a single clinical site. We performed a survey of published reports to assess the potential of the reported information to support FDA approval of a commonly cited investigational imaging agent. Our survey revealed critical data limitations in most publications, all of which reported exploratory clinical studies. Here we summarize the precedent for FDA approval of imaging agents using effectiveness data from publications, FDA guidance, and our experience in reviewing publications. We also present a key-data checklist for investigators to consider in the design, conduct, and reporting of exploratory clinical studies for publication. We encourage editors and peer reviewers to consider requiring these key data when reviewing these reports for publication. © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Advancing and Sustaining a Clinical Teacher Preparation Partnership: An Exploratory Qualitative Case Study

ERIC Educational Resources Information Center

Garrido, Melissa Downey

2012-01-01

The national call to "turn [teacher education] upside down" (National Council for Accreditation of Teacher Education, Report of the Blue Ribbon Panel on Clinical Preparation and Partnerships for Improved Student Learning [NCATE], 2010, p. ii) and states' subsequent commitments to pilot recommendations necessitates study of successful…

Physics Metacognition Inventory Part Ii: Confirmatory Factor Analysis and Rasch Analysis

ERIC Educational Resources Information Center

Taasoobshirazi, Gita; Bailey, MarLynn; Farley, John

2015-01-01

The Physics Metacognition Inventory was developed to measure physics students' metacognition for problem solving. In one of our earlier studies, an exploratory factor analysis provided evidence of preliminary construct validity, revealing six components of students' metacognition when solving physics problems including knowledge of cognition,…

Academic Women in Protest.

ERIC Educational Resources Information Center

Theodore, Athena

This paper is an exploratory inquiry into some aspects of protest for sex equality by academic women. The analysis is based on published and unpublished information on sex discrimination in academia, as well as a sample of 65 cases of academic women obtained from a pilot survey. Following introductory material, Part II emphasizes patterns of…

The Tendril Plot-a novel visual summary of the incidence, significance and temporal aspects of adverse events in clinical trials.

PubMed

Karpefors, Martin; Weatherall, James

2018-03-21

In contrast to efficacy, safety hypotheses of clinical trials are not always pre-specified, and therefore, the safety interpretation work of a trial tends to be more exploratory, often reactive, and the analysis more statistically and graphically challenging. We introduce a new means of visualizing the adverse event data across an entire clinical trial. The approach overcomes some of the current limitations of adverse event analysis and streamlines the way safety data can be explored, interpreted and analyzed. Using a phase II study, we describe and exemplify how the tendril plot effectively summarizes the time-resolved safety profile of two treatment arms in a single plot and how that can provide scientists with a trial safety overview that can support medical decision making. To our knowledge, the tendril plot is the only way to graphically show important treatment differences with preserved temporal information, across an entire clinical trial, in a single view.

Using phase II data for the analysis of phase III studies: An application in rare diseases.

PubMed

Wandel, Simon; Neuenschwander, Beat; Röver, Christian; Friede, Tim

2017-06-01

Clinical research and drug development in orphan diseases are challenging, since large-scale randomized studies are difficult to conduct. Formally synthesizing the evidence is therefore of great value, yet this is rarely done in the drug-approval process. Phase III designs that make better use of phase II data can facilitate drug development in orphan diseases. A Bayesian meta-analytic approach is used to inform the phase III study with phase II data. It is particularly attractive, since uncertainty of between-trial heterogeneity can be dealt with probabilistically, which is critical if the number of studies is small. Furthermore, it allows quantifying and discounting the phase II data through the predictive distribution relevant for phase III. A phase III design is proposed which uses the phase II data and considers approval based on a phase III interim analysis. The design is illustrated with a non-inferiority case study from a Food and Drug Administration approval in herpetic keratitis (an orphan disease). Design operating characteristics are compared to those of a traditional design, which ignores the phase II data. An analysis of the phase II data reveals good but insufficient evidence for non-inferiority, highlighting the need for a phase III study. For the phase III study supported by phase II data, the interim analysis is based on half of the patients. For this design, the meta-analytic interim results are conclusive and would justify approval. In contrast, based on the phase III data only, interim results are inconclusive and require further evidence. To accelerate drug development for orphan diseases, innovative study designs and appropriate methodology are needed. Taking advantage of randomized phase II data when analyzing phase III studies looks promising because the evidence from phase II supports informed decision-making. The implementation of the Bayesian design is straightforward with public software such as R.

Optimising text messaging to improve adherence to web-based smoking cessation treatment: a randomised control trial protocol

PubMed Central

Graham, Amanda L; Jacobs, Megan A; Cohn, Amy M; Cha, Sarah; Abroms, Lorien C; Papandonatos, George D; Whittaker, Robyn

2016-01-01

Introduction Millions of smokers use the Internet for smoking cessation assistance each year; however, most smokers engage minimally with even the best designed websites. The ubiquity of mobile devices and their effectiveness in promoting adherence in other areas of health behaviour change make them a promising tool to address adherence in Internet smoking cessation interventions. Text messaging is used by most adults, and messages can proactively encourage use of a web-based intervention. Text messaging can also be integrated with an Internet intervention to facilitate the use of core Internet intervention components. Methods and analysis We identified four aspects of a text message intervention that may enhance its effectiveness in promoting adherence to a web-based smoking cessation programme: personalisation, integration, dynamic tailoring and message intensity. Phase I will use a two-level full factorial design to test the impact of these four experimental features on adherence to a web-based intervention. The primary outcome is a composite metric of adherence that incorporates general utilisation metrics (eg, logins, page views) and specific feature utilisation shown to predict abstinence. Participants will be N=860 adult smokers who register on an established Internet cessation programme and enrol in its text message programme. Phase II will be a two-arm randomised trial to compare the efficacy of the web-based cessation programme alone and in conjunction with the optimised text messaging intervention on 30-day point prevalence abstinence at 9 months. Phase II participants will be N=600 adult smokers who register to use an established Internet cessation programme and enrol in text messaging. Secondary analyses will explore whether adherence mediates the effect of treatment condition on outcome. Ethics and dissemination This protocol was approved by Chesapeake IRB. We will disseminate study results through peer-reviewed manuscripts and conference presentations related to the methods and design, outcomes and exploratory analyses. Trial registration number NCT02585206. PMID:27029775

Better self-management and meaningful activities thanks to tablets? Development of a person-centered program to support people with mild dementia and their carers through use of hand-held touch screen devices.

PubMed

Kerkhof, Yvonne J F; Graff, Maud J L; Bergsma, Ad; de Vocht, Hilde H M; Dröes, Rose-Marie

2016-11-01

To offer good support to people with dementia and their carers in an aging and Internet society the deployment of hand-held touch screen devices, better known as tablets, and its applications (apps) can be viable and desirable. However, at the moment it is not clear which apps are usable for supporting people with dementia in daily life. Also, little is known about how people with dementia can be coached to learn to use a tablet and its apps. A person-centered program, with tools and training, will be developed that aims to support people with mild dementia and their (in)formal carers in how to use the tablet for self-management and meaningful activities. The program will be developed in accordance with the Medical Research Council's (MRC) framework for developing and evaluating complex interventions and the study will cover the following phases: a preclinical or theoretical (0) phase; a modeling phase (I) and the exploratory trial phase (II). The users (people with dementia and their carers) will be involved intensively during all these phases, by means of individual interviews, workshops, focus groups, and case studies. The iterative process inherent to this framework makes it possible to develop a user-oriented intervention, in this case a person-centered program, for the use of tablets in dementia care. Preparatory work will be done to perform a methodologically sound randomized controlled trial (RCT) in the near future, which aims to investigate the contribution of this person-centered program for tablet use to the quality of life of people with dementia and their carers.

Stop Stroke: development of an innovative intervention to improve risk factor management after stroke.

PubMed

Redfern, Judith; Rudd, Anthony D; Wolfe, Charles D A; McKevitt, Christopher

2008-08-01

Stroke survivors are at high risk of stroke recurrence yet current strategies to reduce recurrence risk are sub-optimal. The UK Medical Research Council (MRC) have proposed a framework for developing and evaluating complex interventions, such as community management of stroke secondary prevention. The Framework outlines a five-phased approach from theory through to implementation of effective interventions. This paper reports Phases I-III of the development of a novel intervention to improve risk factor management after stroke. The pre-clinical/theoretical phase entailed reviewing the literature and undertaking quantitative and qualitative studies to identify current practices and barriers to secondary prevention. In Phase I (modelling), findings were used to design an intervention with the potential to overcome barriers to effective stroke secondary prevention management. The feasibility of delivering the intervention and its acceptability were tested in the Phase II exploratory trial involving 25 stroke survivors and their general practitioners. This led to the development of the definitive risk factor management intervention. This comprises multiple components and involves using an on-going population stroke register to target patients, carers and health care professionals with tailored secondary prevention advice. Clinical, socio-demographic and service use data collected by the stroke register are transformed to provide an individualised secondary prevention package for patients, carers and health care professionals at three time points: within 10 weeks, 3 and 6 months post-stroke. The intervention is currently being evaluated in a randomised controlled trial. Further research is needed to test generalisability to other aspects of stroke management and for other chronic diseases. The MRC Framework for complex interventions provides a structured approach to guide the development of novel interventions in public health. Implications for practice in stroke secondary prevention will emerge when the results of our randomised controlled trial are published.

47 CFR 54.309 - Connect America Fund Phase II Public Interest Obligations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 3 2014-10-01 2014-10-01 false Connect America Fund Phase II Public Interest Obligations. 54.309 Section 54.309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) COMMON... Connect America Fund Phase II Public Interest Obligations. (a) A price cap carrier electing Phase II model...

Applying organization science to assess the management performance of Marine Protected Areas: An exploratory study.

PubMed

Scianna, Claudia; Niccolini, Federico; Bianchi, Carlo Nike; Guidetti, Paolo

2018-06-18

Marine Protected Areas (MPAs) are important tools to achieve marine conservation and resources management goals. The management effectiveness of MPAs (the degree to which MPAs achieve their goals) is highly variable and can be affected by many MPA attributes, for example their design, enforcement and age. Another key factor possibly affecting MPA management effectiveness is the management performance, here conceived according to Horigue et al. definition (2014) as the "level of effort exerted to enhance and sustain management of MPAs". Organization Science (OS), the discipline that studies organizations, can offer a useful framework to assess and interpret MPA management performance. Using an exploratory multiple case study approach, we applied OS principles to 11 Mediterranean MPAs in order to: i) characterize several MPA organizational features; ii) assess MPA management performance (evaluated as the effort deployed in, for example, planning the future, formalizing measurable goals, and implementing specific strategies). Results show that a number of organizational features and networking attributes are highly variable among the MPAs we have studied. For instance, goals are seldom measurable and the strategy to achieve goals is not systematically pursued. Two relevant outcomes emerge from this exploratory study: i) the management performance of the MPAs considered needs considerable improvements; ii) the methods and the approach proposed could help MPAs' managers and policy makers to understand how to improve their management performance and, consequently, their effectiveness. Copyright © 2018. Published by Elsevier Ltd.

Seroprevalence for Coxiella burnetii, Francisella tularensis, Brucella abortus and Brucella melitensis in Austrian adults: a cross-sectional survey among military personnel and civilians.

PubMed

Tobudic, Selma; Nedomansky, Klara; Poeppl, Wolfgang; Müller, Maria; Faas, Angelus; Mooseder, Gerhard; Allerberger, Franz; Stanek, Gerold; Burgmann, Heinz

2014-04-01

The prevalence of Coxiella burnetii, Francisella tularensis, Brucella abortus, and Brucella melitensis infections in Austria and the exposure risk of military personnel were assessed in an exploratory nationwide cross-sectional seroprevalence survey in 526 healthy adult individuals, 222 of which were soldiers and 304 were civilians. Screening for IgA/IgG antibodies to C. burnetii (Phase I) and IgG/IgM antibodies to C. burnetii (Phase II), and to F. tularensis was done with commercial enzyme-linked immunosorbent assays. To detect antibodies against B. abortus and B. melitensis, an in-house complement fixation test was used. Overall, 11 individuals (2.0%) showed antibodies to C. burnetii, 3 individuals (0.5%) were seropositive for F. tularensis, and one (0.3%) individual was borderline positive. All individuals positive or borderline for F. tularensis tested negative for antibodies against C. burnetii. All individuals tested negative for antibodies against B. melitensis/B. abortus. There were no significant differences between the seroprevalence of C. burnetii and F. tularensis among military personnel and civilians. Our data demonstrate serological evidence of a low rate of exposure to C. burnetii and F. tularensis among the Austrian adult population and military personnel. Copyright © 2014 Elsevier GmbH. All rights reserved.

Phase I/II Study of Pre-operative Docetaxel and Mitoxantrone for High-risk Prostate Cancer

PubMed Central

Garzotto, Mark; Higano, Celestia S.; O’Brien, Catherine; Rademacher, Brooks L.S.; Janeba, Nicole; Fazli, Ladan; Lange, Paul H.; Lieberman, Stephen; Beer, Tomasz M.

2009-01-01

Background To determine the 5-year recurrence-free survival in patients with high-risk prostate cancer after neoadjuvant combination chemotherapy followed by surgery. Secondary endpoints included safety, pathologic effects of chemotherapy and predictors of disease recurrence. Patients and Methods Fifty seven patients were enrolled in a Phase I/II study of weekly docetaxel 35 mg/m2 and escalating mitoxantrone to 4 mg/m2 prior to prostatectomy. Patients were treated with 16 weeks of chemotherapy administered weekly on a 3 of every 4 week schedule. A tissue micro-array, constructed from the prostatectomy specimens served to facilitate the exploratory evaluation of biomarkers. The primary end point was relapse-free survival. Relapse was defined as a confirmed serum prostate-specific antigen (PSA) > 0.4 ng/ml. Results Of the 57 patients, 54 received 4 cycles of docetaxel and mitoxantrone prior to radical prostatectomy. Grade 4 toxicities were limited to leucopenia, neutropenia and hyperglycemia. Serum testosterone levels remained stable after chemotherapy. Negative surgical margins were attained in 67% of cases. Lymph node involvement was detected in 18.5% of cases. With a median follow-up of 63 months, 27 of 57 (47.4%) patients recurred. The Kaplan-Meier relapse-free survival at 2 years was 65.5% (95%CI 53.0% to 78.0%) and 49.8% at 5 years (95%CI 35.5% to 64.1%). Pretreatment serum PSA, lymph node involvement, and post-chemotherapy tissue VEGF expression were independent predictors of early relapse. Conclusions Preoperative chemotherapy with docetaxel and mitoxantrone is feasible. Approximately half of the high risk patients remain relapse free at 5 years and clinical and molecular predictors of early relapse were identified. PMID:20143429

A phase II trial of tideglusib in Alzheimer's disease.

PubMed

Lovestone, Simon; Boada, Mercè; Dubois, Bruno; Hüll, Michael; Rinne, Juha O; Huppertz, Hans-Jürgen; Calero, Miguel; Andrés, María V; Gómez-Carrillo, Belén; León, Teresa; del Ser, Teodoro

2015-01-01

The ARGO study was a phase II, double-blind, placebo controlled, four parallel arm trial of tideglusib in Alzheimer's disease (AD). To prove the clinical efficacy of an inhibitor of glycogen synthase kinase-3 (GSK-3), in AD. Mild to moderate (Mini-Mental State Examination (MMSE) score, 14-26) AD patients on cholinesterase inhibitor and/or memantine treatment were administered tideglusib or placebo for 26 weeks. The ADAS-cog15 was the primary efficacy measure; function, cognition, behavior, and quality of life were assessed as secondary measures; cerebral atrophy in MRI and the levels of tau, amyloid-β, and BACE1 in cerebrospinal fluid (CSF) were exploratory endpoints. 306 AD patients were randomized to active (1000 mg QD: n = 86, 1000 mg QOD: n = 90, and 500 mg QD: n = 50) or placebo (n = 85) in 55 sites in four European countries. There were no statistically significant differences between either active and placebo arms in the efficacy variables. However, BACE1 in CSF significantly decreased with treatment in a small subgroup of patients. Participants with mild AD in the 500 mg QD group showed significant responses on ADAS-cog15, MMSE, and word fluency. Diarrhea (14-18% in active, 11% placebo) and dose-dependent, mild to moderate, and fully reversible transaminase increase (9-16% in active, 3.5% placebo) were the most frequent adverse events. Short term (26 weeks) tideglusib was acceptably safe but produced no clinical benefit in this trial. However, given the non-linear dose response, especially in mildly affected patients, further dose finding studies in early disease stages and for longer duration are warranted to examine GSK-3 inhibition in AD patients.

FemZone trial: a randomized phase II trial comparing neoadjuvant letrozole and zoledronic acid with letrozole in primary breast cancer patients

PubMed Central

2014-01-01

Background The objective of this prospectively randomized phase II trial (Trial registration: EUCTR2004-004007-37-DE) was to compare the clinical response of primary breast cancer patients to neoadjuvant therapy with letrozole alone (LET) or letrozole and zoledronic acid (LET + ZOL). Methods Patients were randomly assigned to receive either LET 2.5 mg/day (n = 79) or the combination of LET 2.5 mg/day and a total of seven infusions of ZOL 4 mg every 4 weeks (n = 89) for 6 months. Primary endpoint was clinical response rate as assessed by mammogram readings. The study was terminated prematurely due to insufficient recruitment. We report here on an exploratory analysis of this data. Results Central assessment of tumor sizes during the treatment period was available for 131 patients (66 LET, 65 LET + ZOL). Clinical responses (complete or partial) were seen in 54.5% (95% CI: 41.8-66.9) of the patients in the LET arm and 69.2% (95% CI: 56.6-80.1) of those in the LET + ZOL arm (P = 0.106). A multivariate model showed an OR of 1.72 (95% CI: 0.83-3.59) for the experimental arm. Conclusion No increase in the clinical response rate was observed with the addition of ZOL to a neoadjuvant treatment regimen with LET. However a trend towards a better reponse in the LET + ZOL arm could be observed. This trend is consistent with previous studies that have investigated the addition of ZOL to chemotherapy, and it may support the evidence for a direct antitumor action of zoledronic acid. PMID:24499441

Isac Sc-Linac Phase-II Helium Refrigerator Commissioning and First Operational Experience at Triumf

NASA Astrophysics Data System (ADS)

Sekachev, I.; Kishi, D.; Laxdal, R. E.

2010-04-01

ISAC Phase-II is an upgrade of the radioactive isotope superconducting linear accelerator, SC-linac, at TRIUMF. The Phase-I section of the accelerator, medium-beta, is operational and is cooled with a 600 W helium refrigerator, commissioned in March 2005. An identical refrigerator is being used with the Phase-II segment of the accelerator; which is now under construction. The second refrigerator has been commissioned and tested with the Phase-I section of the linac and is used for Phase-II linac development, including new SC-cavity performance tests. The commissioning of the Phase-II refrigeration system and recent operational experience is presented.

Design of Phase II Non-inferiority Trials.

PubMed

Jung, Sin-Ho

2017-09-01

With the development of inexpensive treatment regimens and less invasive surgical procedures, we are confronted with non-inferiority study objectives. A non-inferiority phase III trial requires a roughly four times larger sample size than that of a similar standard superiority trial. Because of the large required sample size, we often face feasibility issues to open a non-inferiority trial. Furthermore, due to lack of phase II non-inferiority trial design methods, we do not have an opportunity to investigate the efficacy of the experimental therapy through a phase II trial. As a result, we often fail to open a non-inferiority phase III trial and a large number of non-inferiority clinical questions still remain unanswered. In this paper, we want to develop some designs for non-inferiority randomized phase II trials with feasible sample sizes. At first, we review a design method for non-inferiority phase III trials. Subsequently, we propose three different designs for non-inferiority phase II trials that can be used under different settings. Each method is demonstrated with examples. Each of the proposed design methods is shown to require a reasonable sample size for non-inferiority phase II trials. The three different non-inferiority phase II trial designs are used under different settings, but require similar sample sizes that are typical for phase II trials.

Sources of Self-Efficacy in Mathematics: A Validation Study

ERIC Educational Resources Information Center

Usher, Ellen L.; Pajares, Frank

2009-01-01

The purpose of this study was to develop and validate items with which to assess A. Bandura's (1997) theorized sources of self-efficacy among middle school mathematics students. Results from Phase 1 (N=1111) were used to develop and refine items for subsequent use. In Phase 2 of the study (N=824), a 39-item, four-factor exploratory model fit best.…

An exploratory case study of the impact of ambient biographical displays on identity in a patient with Alzheimer's disease.

PubMed

Massimi, Michael; Berry, Emma; Browne, Georgina; Smyth, Gavin; Watson, Peter; Baecker, Ronald M

2008-01-01

One of the most troubling symptoms of Alzheimer's disease is the loss of the patient's sense of identity. This loss complicates relationships, increases apathy, and generally impedes quality of life for the patient. We describe a novel in-home ambient display called Biography Theatre that cycles through music, photographs, movies, and narratives drawn from the patient's past and current life. We conducted an exploratory case study with an 84-year-old male with moderate-stage Alzheimer's disease (Mr H). The study consisted of three phases: a baseline phase, a phase wherein autobiographical materials were collected and discussed, and a phase wherein the display was deployed in the home. The patient demonstrated improvement on standardised tests of apathy and positive self-identity, but did not improve on tests of autobiographical memory, anxiety, depression, and general cognition. We also report on caregiver reactions to the intervention and how the display helped them cope with and reinterpret their loved one's condition. This work suggests that interdisciplinary work involving "off the desktop" computing technologies may be a fruitful way to provide rehabilitative benefit for individuals with Alzheimer's disease.

Realist explanatory theory building method for social epidemiology: a protocol for a mixed method multilevel study of neighbourhood context and postnatal depression.

PubMed

Eastwood, John G; Jalaludin, Bin B; Kemp, Lynn A

2014-01-01

A recent criticism of social epidemiological studies, and multi-level studies in particular has been a paucity of theory. We will present here the protocol for a study that aims to build a theory of the social epidemiology of maternal depression. We use a critical realist approach which is trans-disciplinary, encompassing both quantitative and qualitative traditions, and that assumes both ontological and hierarchical stratification of reality. We describe a critical realist Explanatory Theory Building Method comprising of an: 1) emergent phase, 2) construction phase, and 3) confirmatory phase. A concurrent triangulated mixed method multilevel cross-sectional study design is described. The Emergent Phase uses: interviews, focus groups, exploratory data analysis, exploratory factor analysis, regression, and multilevel Bayesian spatial data analysis to detect and describe phenomena. Abductive and retroductive reasoning will be applied to: categorical principal component analysis, exploratory factor analysis, regression, coding of concepts and categories, constant comparative analysis, drawing of conceptual networks, and situational analysis to generate theoretical concepts. The Theory Construction Phase will include: 1) defining stratified levels; 2) analytic resolution; 3) abductive reasoning; 4) comparative analysis (triangulation); 5) retroduction; 6) postulate and proposition development; 7) comparison and assessment of theories; and 8) conceptual frameworks and model development. The strength of the critical realist methodology described is the extent to which this paradigm is able to support the epistemological, ontological, axiological, methodological and rhetorical positions of both quantitative and qualitative research in the field of social epidemiology. The extensive multilevel Bayesian studies, intensive qualitative studies, latent variable theory, abductive triangulation, and Inference to Best Explanation provide a strong foundation for Theory Construction. The study will contribute to defining the role that realism and mixed methods can play in explaining the social determinants and developmental origins of health and disease.

78 FR 76789 - Additional Connect America Fund Phase II Issues

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-19

... inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445... Phase I to Phase II. 2. Timing of Phase II Support Disbursements. In the USF/ICC Transformation Order... language in paragraph 180 of the USF/ICC Transformation Order. We now seek to more fully develop the record...

48 CFR 1852.219-81 - Limitation on subcontracting-SBIR Phase II program.

Code of Federal Regulations, 2014 CFR

2014-10-01

... subcontracting-SBIR Phase II program. 1852.219-81 Section 1852.219-81 Federal Acquisition Regulations System... CLAUSES Texts of Provisions and Clauses 1852.219-81 Limitation on subcontracting—SBIR Phase II program. As prescribed in 1819.7302(b), insert the following clause: Limitation on Subcontracting—SBIR Phase II Program...

48 CFR 1852.219-81 - Limitation on subcontracting-SBIR Phase II program.

Code of Federal Regulations, 2013 CFR

2013-10-01

... subcontracting-SBIR Phase II program. 1852.219-81 Section 1852.219-81 Federal Acquisition Regulations System... CLAUSES Texts of Provisions and Clauses 1852.219-81 Limitation on subcontracting—SBIR Phase II program. As prescribed in 1819.7302(b), insert the following clause: Limitation on Subcontracting—SBIR Phase II Program...

48 CFR 1852.219-81 - Limitation on subcontracting-SBIR Phase II program.

Code of Federal Regulations, 2012 CFR

2012-10-01

... subcontracting-SBIR Phase II program. 1852.219-81 Section 1852.219-81 Federal Acquisition Regulations System... CLAUSES Texts of Provisions and Clauses 1852.219-81 Limitation on subcontracting—SBIR Phase II program. As prescribed in 1819.7302(b), insert the following clause: Limitation on Subcontracting—SBIR Phase II Program...

Effect of the Level of Inquiry on Student Interactions in Chemistry Laboratories

ERIC Educational Resources Information Center

Xu, Haozhi; Talanquer, Vicente

2013-01-01

The central goal of our exploratory study was to investigate differences in college chemistry students' interactions during lab experiments with different levels of inquiry. This analysis was approached from three major analytic dimensions: (i) functional analysis; (ii) cognitive processing; and (iii) social processing. According to our results,…

Career Pathways of Athletic Directors: Consideration of the Impact of Diversity

ERIC Educational Resources Information Center

Armstrong, Lenora E.

2011-01-01

This study explored career pathways for becoming an athletic director (AD) at National Collegiate Athletic Association (NCAA) Divisions I, II, and, III member institutions with consideration of gender and race/ethnicity. The study employed an exploratory, descriptive research design using a quantitative electronic survey tapping a census of all…

Twenty Years In: An Essay in Two Parts

ERIC Educational Resources Information Center

Heilker, Paul

2006-01-01

Part I of this essay traces the evolution of my understanding of the exploratory essay as a discursive form and a genre for teaching writing. Part II explores my motivations for advocating a polarized definition of the essay and then concludes with a call to expand the purview of composition beyond first-year courses.

Inheriting Failure: An Exploratory Study of Post-Colonial Somalia

DTIC Science & Technology

2014-12-01

12b. DISTRIBUTION CODE A 13. ABSTRACT (maximum 200 words) ] Throughout its history , Somalia has experienced varying degrees of instability that has...Defense Analysis iii THIS PAGE INTENTIONALLY LEFT BLANK iv ABSTRACT Throughout its history , Somalia has experienced varying degrees of...1 A. STATE-SOCIETY RELATIONS...................................................................3 II. THE COLONIAL HISTORY OF SOMALIA

Rational Clinical Experiment: Assessing Prior Probability and Its Impact on the Success of Phase II Clinical Trials

PubMed Central

Halperin, Daniel M.; Lee, J. Jack; Dagohoy, Cecile Gonzales; Yao, James C.

2015-01-01

Purpose Despite a robust clinical trial enterprise and encouraging phase II results, the vast minority of oncologic drugs in development receive regulatory approval. In addition, clinicians occasionally make therapeutic decisions based on phase II data. Therefore, clinicians, investigators, and regulatory agencies require improved understanding of the implications of positive phase II studies. We hypothesized that prior probability of eventual drug approval was significantly different across GI cancers, with substantial ramifications for the predictive value of phase II studies. Methods We conducted a systematic search of phase II studies conducted between 1999 and 2004 and compared studies against US Food and Drug Administration and National Cancer Institute databases of approved indications for drugs tested in those studies. Results In all, 317 phase II trials were identified and followed for a median of 12.5 years. Following completion of phase III studies, eventual new drug application approval rates varied from 0% (zero of 45) in pancreatic adenocarcinoma to 34.8% (24 of 69) for colon adenocarcinoma. The proportion of drugs eventually approved was correlated with the disease under study (P < .001). The median type I error for all published trials was 0.05, and the median type II error was 0.1, with minimal variation. By using the observed median type I error for each disease, phase II studies have positive predictive values ranging from less than 1% to 90%, depending on primary site of the cancer. Conclusion Phase II trials in different GI malignancies have distinct prior probabilities of drug approval, yielding quantitatively and qualitatively different predictive values with similar statistical designs. Incorporation of prior probability into trial design may allow for more effective design and interpretation of phase II studies. PMID:26261263

Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual.

PubMed

Massett, Holly A; Mishkin, Grace; Rubinstein, Larry; Ivy, S Percy; Denicoff, Andrea; Godwin, Elizabeth; DiPiazza, Kate; Bolognese, Jennifer; Zwiebel, James A; Abrams, Jeffrey S

2016-11-15

Accruing patients in a timely manner represents a significant challenge to early phase cancer clinical trials. The NCI Cancer Therapy Evaluation Program analyzed 19 months of corrective action plans (CAP) received for slow-accruing phase I and II trials to identify slow accrual reasons, evaluate whether proposed corrective actions matched these reasons, and assess the CAP impact on trial accrual, duration, and likelihood of meeting primary scientific objectives. Of the 135 CAPs analyzed, 69 were for phase I trials and 66 for phase II trials. Primary reasons cited for slow accrual were safety/toxicity (phase I: 48%), design/protocol concerns (phase I: 42%, phase II: 33%), and eligibility criteria (phase I: 41%, phase II: 35%). The most commonly proposed corrective actions were adding institutions (phase I: 43%, phase II: 85%) and amending the trial to change eligibility or design (phase I: 55%, phase II: 44%). Only 40% of CAPs provided proposed corrective actions that matched the reasons given for slow accrual. Seventy percent of trials were closed to accrual at time of analysis (phase I = 48; phase II = 46). Of these, 67% of phase I and 70% of phase II trials met their primary objectives, but they were active three times longer than projected. Among closed trials, 24% had an accrual rate increase associated with a greater likelihood of meeting their primary scientific objectives. Ultimately, trials receiving CAPs saw improved accrual rates. Future trials may benefit from implementing CAPs early in trial life cycles, but it may be more beneficial to invest in earlier accrual planning. Clin Cancer Res; 22(22); 5408-16. ©2016 AACRSee related commentary by Mileham and Kim, p. 5397. ©2016 American Association for Cancer Research.

Measuring adolescent science motivation

NASA Astrophysics Data System (ADS)

Schumm, Maximiliane F.; Bogner, Franz X.

2016-02-01

To monitor science motivation, 232 tenth graders of the college preparatory level ('Gymnasium') completed the Science Motivation Questionnaire II (SMQ-II). Additionally, personality data were collected using a 10-item version of the Big Five Inventory. A subsequent exploratory factor analysis based on the eigenvalue-greater-than-one criterion, extracted a loading pattern, which in principle, followed the SMQ-II frame. Two items were dropped due to inappropriate loadings. The remaining SMQ-II seems to provide a consistent scale matching the findings in literature. Nevertheless, also possible shortcomings of the scale are discussed. Data showed a higher perceived self-determination in girls which seems compensated by their lower self-efficacy beliefs leading to equality of females and males in overall science motivation scores. Additionally, the Big Five personality traits and science motivation components show little relationship.

Enhanced Night Visibility Series, Volume XII : Overview of Phase II and Development of Phase III Experimental Plan

DOT National Transportation Integrated Search

2005-12-01

This volume provides an overview of the six studies that compose Phase II of the Enhanced Night Visibility project and the experimental plan for its third and final portion, Phase III. The Phase II studies evaluated up to 12 vision enhancement system...

Shipboard Crew Fatigue, Safety and Reduced Manning

DOT National Transportation Integrated Search

1990-11-01

This report describes an exploratory first phase of an investigation of human stress and : fatigue in the merchant marine. Its principal purposes were to: survey the effects of : fatigue on human performance in the transportation industries; describe...

Needs of family caregivers in home care for older adults 1

PubMed Central

Bierhals, Carla Cristiane Becker Kottwitz; dos Santos, Naiana Oliveira; Fengler, Fernanda Laís; Raubustt, Kamila Dellamora; Forbes, Dorothy Anne; Paskulin, Lisiane Manganelli Girardi

2017-01-01

ABSTRACT Objective: to reveal the felt and normative needs of primary family caregivers when providing instrumental support to older adults enrolled in a Home Care Program in a Primary Health Service in the South of Brazil. Methods: using Bradshaw's taxonomy of needs to explore the caregiver's felt needs (stated needs) and normative needs (defined by professionals), a mixed exploratory study was conducted in three steps: Descriptive quantitative phase with 39 older adults and their caregiver, using a data sheet based on patient records; Qualitative exploratory phase that included 21 caregiver interviews, analyzed by content analysis; Systematic observation, using an observation guide with 16 caregivers, analyzed by descriptive statistics. Results: the felt needs were related to information about instrumental support activities and subjective aspects of care. Caregivers presented more normative needs related to medications care. Conclusion: understanding caregivers' needs allows nurses to plan interventions based on their particularities. PMID:28403338

An Exploratory Analysis of Economic Factors in the Navy Total Force Strength Model (NTFSM)

DTIC Science & Technology

2015-12-01

NTFSM is still in the testing phase and its overall behavior is largely unknown. In particular, the analysts that NTFSM was designed to help are...NTFSM is still in the testing phase and its overall behavior is largely unknown. In particular, the analysts that NTFSM was designed to help are...7 B. NTFSM VERIFICATION AND TESTING ......................................... 8 C

Development and validation of a new knowledge, attitude, belief and practice questionnaire on leptospirosis in Malaysia.

PubMed

Zahiruddin, Wan Mohd; Arifin, Wan Nor; Mohd-Nazri, Shafei; Sukeri, Surianti; Zawaha, Idris; Bakar, Rahman Abu; Hamat, Rukman Awang; Malina, Osman; Jamaludin, Tengku Zetty Maztura Tengku; Pathman, Arumugam; Mas-Harithulfadhli-Agus, Ab Rahman; Norazlin, Idris; Suhailah, Binti Samsudin; Saudi, Siti Nor Sakinah; Abdullah, Nurul Munirah; Nozmi, Noramira; Zainuddin, Abdul Wahab; Aziah, Daud

2018-03-07

In Malaysia, leptospirosis is considered an endemic disease, with sporadic outbreaks following rainy or flood seasons. The objective of this study was to develop and validate a new knowledge, attitude, belief and practice (KABP) questionnaire on leptospirosis for use in urban and rural populations in Malaysia. The questionnaire comprised development and validation stages. The development phase encompassed a literature review, expert panel review, focus-group testing, and evaluation. The validation phase consisted of exploratory and confirmatory parts to verify the psychometric properties of the questionnaire. A total of 214 and 759 participants were recruited from two Malaysian states, Kelantan and Selangor respectively, for the validation phase. The participants comprised urban and rural communities with a high reported incidence of leptospirosis. The knowledge section of the validation phase utilized item response theory (IRT) analysis. The attitude and belief sections utilized exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). The development phase resulted in a questionnaire that included four main sections: knowledge, attitude, belief, and practice. In the exploratory phase, as shown by the IRT analysis of knowledge about leptospirosis, the difficulty and discrimination values of the items were acceptable, with the exception of two items. Based on the EFA, the psychometric properties of the attitude, belief, and practice sections were poor. Thus, these sections were revised, and no further factor analysis of the practice section was conducted. In the confirmatory stage, the difficulty and discrimination values of the items in the knowledge section remained within the acceptable range. The CFA of the attitude section resulted in a good-fitting two-factor model. The CFA of the belief section retained low number of items, although the analysis resulted in a good fit in the final three-factor model. Based on the IRT analysis and factor analytic evidence, the knowledge and attitude sections of the KABP questionnaire on leptospirosis were psychometrically valid. However, the psychometric properties of the belief section were unsatisfactory, despite being revised after the initial validation study. Further development of this section is warranted in future studies.

Change of motion and localization of cholesterol molecule during L(alpha)-H(II) transition.

PubMed Central

Hayakawa, E; Naganuma, M; Mukasa, K; Shimozawa, T; Araiso, T

1998-01-01

Formation of the inverted hexagonal (H(II)) phase from the lamellar (L(alpha)) phase of bovine brain-extracted phosphatidylcholine (BBPC) and phosphatidylethanolamine (BBPE) was investigated using 31P-NMR with or without cholesterol. When the ratio of BBPC to BBPE was 1:1, the H(II) formation was observed in the presence of 33 mol% cholesterol (i.e., BBPC:BBPE:cholesterol = 1:1:1) at 47 degrees C. The fraction of the H(II) phase in the BBPC/BBPE/cholesterol system could be controlled by the addition of dioleoylglycerol. The change of molecular motion of cholesterol affected by the H(II) formation was measured at various ratios of the L(alpha) to H(II) phase with the time-resolved fluorescence depolarization method, using dehydroergosterol as a fluorescent probe. It is observed that the motion of cholesterol became vigorous in the mixture state of the L(alpha) and the H(II) phases compared to that in the L(alpha) or the H(II) phase only. These facts show that cholesterol has the strong ability to induce the H(II) phase, probably by special molecular motion, which includes change of its location from the headgroup area to the acyl-chain area. PMID:9533700

Shared communication processes within healthcare teams for rare diseases and their influence on healthcare professionals' innovative behavior and patient satisfaction

PubMed Central

2011-01-01

Background A rare disease is a pattern of symptoms that afflicts less than five in 10,000 patients. However, as about 6,000 different rare disease patterns exist, they still have significant epidemiological relevance. We focus on rare diseases that affect multiple organs and thus demand that multidisciplinary healthcare professionals (HCPs) work together. In this context, standardized healthcare processes and concepts are mainly lacking, and a deficit of knowledge induces uncertainty and ambiguity. As such, individualized solutions for each patient are needed. This necessitates an intensive level of innovative individual behavior and thus, adequate idea generation. The final implementation of new healthcare concepts requires the integration of the expertise of all healthcare team members, including that of the patients. Therefore, knowledge sharing between HCPs and shared decision making between HCPs and patients are important. The objective of this study is to assess the contribution of shared communication and decision-making processes in patient-centered healthcare teams to the generation of innovative concepts and consequently to improvements in patient satisfaction. Methods A theoretical framework covering interaction processes and explorative outcomes, and using patient satisfaction as a measure for operational performance, was developed based on healthcare management, innovation, and social science literature. This theoretical framework forms the basis for a three-phase, mixed-method study. Exploratory phase I will first involve collecting qualitative data to detect central interaction barriers within healthcare teams. The results are related back to theory, and testable hypotheses will be derived. Phase II then comprises the testing of hypotheses through a quantitative survey of patients and their HCPs in six different rare disease patterns. For each of the six diseases, the sample should comprise an average of 30 patients with six HCP per patient-centered healthcare team. Finally, in phase III, qualitative data will be generated via semi-structured telephone interviews with patients to gain a deeper understanding of the communication processes and initiatives that generate innovative solutions. Discussion The findings of this proposed study will help to elucidate the necessity of individualized innovative solutions for patients with rare diseases. Therefore, this study will pinpoint the primary interaction and communication processes in multidisciplinary teams, as well as the required interplay between exploratory outcomes and operational performance. Hence, this study will provide healthcare institutions and HCPs with results and information essential for elaborating and implementing individual care solutions through the establishment of appropriate interaction and communication structures and processes within patient-centered healthcare teams. PMID:21510848

Shared communication processes within healthcare teams for rare diseases and their influence on healthcare professionals' innovative behavior and patient satisfaction.

PubMed

Hannemann-Weber, Henrike; Kessel, Maura; Budych, Karolina; Schultz, Carsten

2011-04-21

A rare disease is a pattern of symptoms that afflicts less than five in 10,000 patients. However, as about 6,000 different rare disease patterns exist, they still have significant epidemiological relevance. We focus on rare diseases that affect multiple organs and thus demand that multidisciplinary healthcare professionals (HCPs) work together. In this context, standardized healthcare processes and concepts are mainly lacking, and a deficit of knowledge induces uncertainty and ambiguity. As such, individualized solutions for each patient are needed. This necessitates an intensive level of innovative individual behavior and thus, adequate idea generation. The final implementation of new healthcare concepts requires the integration of the expertise of all healthcare team members, including that of the patients. Therefore, knowledge sharing between HCPs and shared decision making between HCPs and patients are important. The objective of this study is to assess the contribution of shared communication and decision-making processes in patient-centered healthcare teams to the generation of innovative concepts and consequently to improvements in patient satisfaction. A theoretical framework covering interaction processes and explorative outcomes, and using patient satisfaction as a measure for operational performance, was developed based on healthcare management, innovation, and social science literature. This theoretical framework forms the basis for a three-phase, mixed-method study. Exploratory phase I will first involve collecting qualitative data to detect central interaction barriers within healthcare teams. The results are related back to theory, and testable hypotheses will be derived. Phase II then comprises the testing of hypotheses through a quantitative survey of patients and their HCPs in six different rare disease patterns. For each of the six diseases, the sample should comprise an average of 30 patients with six HCP per patient-centered healthcare team. Finally, in phase III, qualitative data will be generated via semi-structured telephone interviews with patients to gain a deeper understanding of the communication processes and initiatives that generate innovative solutions. The findings of this proposed study will help to elucidate the necessity of individualized innovative solutions for patients with rare diseases. Therefore, this study will pinpoint the primary interaction and communication processes in multidisciplinary teams, as well as the required interplay between exploratory outcomes and operational performance. Hence, this study will provide healthcare institutions and HCPs with results and information essential for elaborating and implementing individual care solutions through the establishment of appropriate interaction and communication structures and processes within patient-centered healthcare teams.

Flight Test of the F/A-18 Active Aeroelastic Wing Airplane

NASA Technical Reports Server (NTRS)

Voracek, David

2007-01-01

A viewgraph presentation of flight tests performed on the F/A active aeroelastic wing airplane is shown. The topics include: 1) F/A-18 AAW Airplane; 2) F/A-18 AAW Control Surfaces; 3) Flight Test Background; 4) Roll Control Effectiveness Regions; 5) AAW Design Test Points; 6) AAW Phase I Test Maneuvers; 7) OBES Pitch Doublets; 8) OBES Roll Doublets; 9) AAW Aileron Flexibility; 10) Phase I - Lessons Learned; 11) Control Law Development and Verification & Validation Testing; 12) AAW Phase II RFCS Envelopes; 13) AAW 1-g Phase II Flight Test; 14) Region I - Subsonic 1-g Rolls; 15) Region I - Subsonic 1-g 360 Roll; 16) Region II - Supersonic 1-g Rolls; 17) Region II - Supersonic 1-g 360 Roll; 18) Region III - Subsonic 1-g Rolls; 19) Roll Axis HOS/LOS Comparison Region II - Supersonic (open-loop); 20) Roll Axis HOS/LOS Comparison Region II - Supersonic (closed-loop); 21) AAW Phase II Elevated-g Flight Test; 22) Region I - Subsonic 4-g RPO; and 23) Phase II - Lessons Learned

The expression of cytokines and chemokines in the blood of patients with severe weight loss from anorexia nervosa: an exploratory study.

PubMed

Pisetsky, D S; Trace, S E; Brownley, K A; Hamer, R M; Zucker, N L; Roux-Lombard, P; Dayer, J-M; Bulik, C M

2014-09-01

Anorexia nervosa (AN) is a serious, potentially life-threatening disorder characterized by severe weight loss, dysregulated eating, and often excessive exercise. While psychiatric illnesses such as depression are associated with increased levels of pro-inflammatory mediators, evidence for such disturbances in patients with AN has been less clear. In an exploratory study of possible disturbances in immune responses in AN, we assayed a panel of cytokines and chemokines in the blood of patients undergoing inpatient treatment, testing the hypothesis that metabolic disturbances in this disease would lead to a pattern of immune disturbances distinct from that of other psychiatric diseases. For this purpose, we evaluated patients by the Beck Depression Inventory-II (BDI-II) and the Eating Disorders Examination-Questionnaire and assessed cytokines and chemokines by enzyme-linked immunosorbent assays. Patients reported a moderate level of depression (mean BDI-II = 22.6) but exhibited few immunologic abnormalities of the kind associated with major depressive disorder [e.g., increased interleukin (IL)-6]; RANTES showed the most frequent elevations and was increased in 4 of the patients studied. Together, these findings suggest that features of AN such as loss of adipose tissue and excessive exercise may attenuate cytokine production and thus modulate the experience of illness that impacts on core features of disease. Copyright © 2014 Elsevier Ltd. All rights reserved.

Installation Restoration Program. Phase II--Confirmation/Quantification. Stage 1.

DTIC Science & Technology

1985-03-01

four phases. Phase I, Initial Assessment/ Records Search, is designed to identify possible hazardous waste contami- nated sites and potential...7 71 -. - - IL’ -, 1% 33 AihlIII Is 33 n~iL t iiC UII! ii CL C LU 1-3, Phase II, Confirmation and Quantification, is designed to confirm the...additional monitoring data upon which design of mitigative actions are based. In Phase III, Technology Base Development, appropriate technology is selected and

Installation Restoration Program. Phase II: Stage 1 Problem Confirmation Study, Duluth International Airport, Duluth, Minnesota.

DTIC Science & Technology

1984-10-01

8 iii "i t-. Table of Contents (cont.) Section Title Page -APPENDIX A Acronyms, Definitions, Nomenclature and Units of Measure B Scope of Work, Task...Identification/Records Search Phase II - Problem Confirmation and Quantification Phase III - Technology Base Development Phase IV - Corrective Action Only...Problem Identification/Records Search Phase II - Problem Confirmation and Quantification Phase III - Technology Base Development Phase IV - Corrective

Attentional Preference and Experience: II. An Exploratory Longitudinal Study of the Effects of Visual Familiarity and Responsiveness.

ERIC Educational Resources Information Center

Uzgiris, Ina C.; Hunt, J. McV.

The human infant is now considered capable of active informational interaction with the environment. This study tested certain hypotheses concerning the nature of that interaction. These hypotheses, developed partly from Piaget's work, are (1) that repeated visual encounters with a stimulus pattern leads first to attentional preference for that…

Young People and Newspapers: An Exploratory Study. Part II.

ERIC Educational Resources Information Center

Yankelovich, Skelly and White, Inc., New York, NY.

This second part of a two-part report is based on preliminary findings of an investigation into the recent decline in newspaper reading among young adults approximately 18 to 24 years old. It presents more then 50 hypotheses for the decline, derived from the findings of the investigation, documents them with verbatim quotes from members of the…

The Afro-American Work/Family Nexus: An Exploratory Analysis.

ERIC Educational Resources Information Center

Collins, Patricia Hill

1986-01-01

Sketches out a framework linking black labor market trends in the post World War II era to actual and potential changes in black family patterns. Summarizes selected scholarship and then provides a gender-specific analysis of the changing employment status of black Americans. Urgres that links be made between black family life and the political…

Oral Sulforaphane increases Phase II antioxidant enzymes in the human upper airway

PubMed Central

Riedl, Marc A.; Saxon, Andrew; Diaz-Sanchez, David

2009-01-01

Background Cellular oxidative stress is an important factor in asthma and is thought to be the principle mechanism by which oxidant pollutants such as ozone and particulates mediate their pro-inflammatory effects. Endogenous Phase II enzymes abrogate oxidative stress through the scavenging of reactive oxygen species and metabolism of reactive chemicals. Objective We conducted a placebo-controlled dose escalation trial to investigate the in vivo effects of sulforaphane, a naturally occurring potent inducer of Phase II enzymes, on the expression of glutathione-s-transferase M1 (GSTM1), glutathione-s-transferase P1 (GSTP1), NADPH quinone oxidoreductase (NQO1), and hemoxygenase-1 (HO-1) in the upper airway of human subjects. Methods Study subjects consumed oral sulforaphane doses contained in a standardized broccoli sprout homogenate (BSH). RNA expression for selected Phase II enzymes was measured in nasal lavage cells by RT-PCR before and after sulforaphane dosing. Results All subjects tolerated oral sulforaphane dosing without significant adverse events. Increased Phase II enzyme expression in nasal lavage cells occurred in a dose-dependent manner with maximal enzyme induction observed at the highest dose of 200 grams broccoli sprouts prepared as BSH. Significant increases were seen in all sentinel Phase II enzymes RNA expression compared to baseline. Phase II enzyme induction was not seen with ingestion of non-sulforaphane containing alfalfa sprouts. Conclusion Oral sulforaphane safely and effectively induces mucosal Phase II enzyme expression in the upper airway of human subjects. This study demonstrates the potential of antioxidant Phase II enzymes induction in the human airway as a strategy to reduce the inflammatory effects of oxidative stress. Clinical Implications This study demonstrates the potential of enhancement of Phase II enzyme expression as a novel therapeutic strategy for oxidant induced airway disease. Capsule Summary A placebo-controlled dose escalation trial demonstrated that naturally occurring sulforaphane from broccoli sprouts can induce a potent increase in antioxidant Phase II enzymes in airway cells. PMID:19028145

Centrifuge workers study. Phase II, completion report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wooten, H.D.

1994-09-01

Phase II of the Centrifuge Workers Study was a follow-up to the Phase I efforts. The Phase I results had indicated a higher risk than expected among centrifuge workers for developing bladder cancer when compared with the risk in the general population for developing this same type of cancer. However, no specific agent could be identified as the causative agent for these bladder cancers. As the Phase II Report states, Phase I had been limited to workers who had the greatest potential for exposure to substances used in the centrifuge process. Phase II was designed to expand the survey tomore » evaluate the health of all employees who had ever worked in Centrifuge Program Departments 1330-1339 but who had not been interviewed in Phase I. Employees in analytical laboratories and maintenance departments who provided support services for the Centrifuge Program were also included in Phase II. In December 1989, the Oak Ridge Associated Universities (ORAU), now known as Oak Ridge Institute for Science and Education (ORISE), was contracted to conduct a follow-up study (Phase II). Phase H of the Centrifuge Workers Study expanded the survey to include all former centrifuge workers who were not included in Phase I. ORISE was chosen because they had performed the Phase I tasks and summarized the corresponding survey data therefrom.« less

Development and Initial Validation of the Five-Factor Model Adolescent Personality Questionnaire (FFM-APQ).

PubMed

Rogers, Mary E; Glendon, A Ian

2018-01-01

This research reports on the 4-phase development of the 25-item Five-Factor Model Adolescent Personality Questionnaire (FFM-APQ). The purpose was to develop and determine initial evidence for validity of a brief adolescent personality inventory using a vocabulary that could be understood by adolescents up to 18 years old. Phase 1 (N = 48) consisted of item generation and expert (N = 5) review of items; Phase 2 (N = 179) involved item analyses; in Phase 3 (N = 496) exploratory factor analysis assessed the underlying structure; in Phase 4 (N = 405) confirmatory factor analyses resulted in a 25-item inventory with 5 subscales.

Exploratory studies to decide whether and how to proceed with full-scale evaluations of public health interventions: a systematic review of guidance.

PubMed

Hallingberg, Britt; Turley, Ruth; Segrott, Jeremy; Wight, Daniel; Craig, Peter; Moore, Laurence; Murphy, Simon; Robling, Michael; Simpson, Sharon Anne; Moore, Graham

2018-01-01

Evaluations of complex interventions in public health are frequently undermined by problems that can be identified before the effectiveness study stage. Exploratory studies, often termed pilot and feasibility studies, are a key step in assessing the feasibility and value of progressing to an effectiveness study. Such studies can provide vital information to support more robust evaluations, thereby reducing costs and minimising potential harms of the intervention. This systematic review forms the first phase of a wider project to address the need for stand-alone guidance for public health researchers on designing and conducting exploratory studies. The review objectives were to identify and examine existing recommendations concerning when such studies should be undertaken, questions they should answer, suitable methods, criteria for deciding whether to progress to an effectiveness study and appropriate reporting. We searched for published and unpublished guidance reported between January 2000 and November 2016 via bibliographic databases, websites, citation tracking and expert recommendations. Included papers were thematically synthesized. The search retrieved 4095 unique records. Thirty papers were included, representing 25 unique sources of guidance/recommendations. Eight themes were identified: pre-requisites for conducting an exploratory study, nomenclature, guidance for intervention assessment, guidance surrounding any future evaluation study design, flexible versus fixed design, progression criteria to a future evaluation study, stakeholder involvement and reporting of exploratory studies. Exploratory studies were described as being concerned with the intervention content, the future evaluation design or both. However, the nomenclature and endorsed methods underpinning these aims were inconsistent across papers. There was little guidance on what should precede or follow an exploratory study and decision-making surrounding this. Existing recommendations are inconsistent concerning the aims, designs and conduct of exploratory studies, and guidance is lacking on the evidence needed to inform when to proceed to an effectiveness study. PROSPERO 2016, CRD42016047843.

Examination of the Beck Depression Inventory-II Factor Structure Among Bariatric Surgery Candidates.

PubMed

Hayes, Sharon; Stoeckel, Nina; Napolitano, Melissa A; Collins, Charlotte; Wood, G Craig; Seiler, Jamie; Grunwald, Heidi E; Foster, Gary D; Still, Christopher D

2015-07-01

The Beck Depression Inventory-II (BDI-II) is frequently used to evaluate bariatric patients in clinical and research settings; yet, there are limited data regarding the factor structure of the BDI-II with a bariatric surgery population. Exploratory factor analysis (EFA) using principal axis factoring with oblimin rotation was employed with data from 1228 consecutive presurgical bariatric candidates. Independent t tests were used to examine potential differences between sexes. Confirmatory factor analysis (CFA) was conducted with the next 383 consecutive presurgical patients to evaluate the proposed model based on EFA results. EFA revealed three factors: negative perceptions, diminished vigor, and cognitive dysregulation, each with adequate internal consistency. Six BDI-II items did not load significantly on any of the three factors. CFA results largely supported the proposed model. Results suggest that dimensions of depression for presurgical bariatric candidates vary from other populations and raise important caveats regarding the utility of the BDI-II in bariatric research.

Validation of the Parental Facilitation of Mastery Scale-II.

PubMed

Zalta, Alyson K; Allred, Kelly M; Jayawickreme, Eranda; Blackie, Laura E R; Chambless, Dianne L

2017-10-01

To develop a more reliable and comprehensive version of the Parental Facilitation of Mastery Scale (PFMS) METHOD: In Study 1, 387 undergraduates completed an expanded PFMS (PFMS-II) and measures of parenting, perceived control, responses to early life challenges, and psychopathology. In Study 2, 182 trauma-exposed community participants completed the PFMS-II and measures of perceived control, psychopathology, and well-being RESULTS: In Study 1, exploratory factor analysis of the PFMS-II revealed two factors. These factors replicated in Study 2; one item was removed to achieve measurement invariance across race. The final PFMS-II comprised a 10-item overprotection scale and a 7-item challenge scale. In both samples, this measure demonstrated good convergent and discriminant validity and was more reliable than the original PFMS. Parental challenge was a unique predictor of perceived control in both samples CONCLUSION: The PFMS-II is a valid measure of important parenting behaviors not fully captured in other measures. © 2016 Wiley Periodicals, Inc.

A Phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-α) in patients with systemic lupus erythematosus (ROSE).

PubMed

Kalunian, Kenneth C; Merrill, Joan T; Maciuca, Romeo; McBride, Jacqueline M; Townsend, Michael J; Wei, Xiaohui; Davis, John C; Kennedy, William P

2016-01-01

To examine the safety and efficacy of rontalizumab, a humanised IgG1 anti-interferon α (anti-IFN-α) monoclonal antibody, in patients with moderate-to-severe systemic lupus erythematosus (SLE). Patients with active SLE were randomised (2:1) to 750 mg intravenous rontalizumab every 4 weeks or placebo (Part 1), and 300 mg subcutaneous rontalizumab every 2 weeks or placebo (Part 2). Hydroxychloroquine and corticosteroids were allowed. Patients taking immunosuppressants at baseline were required per protocol to discontinue. Efficacy end points included reduction in disease activity by British Isles Lupus Disease Activity Group (BILAG)-2004 (primary), and SLE response index (SRI, secondary) at Week 24. Efficacy was also examined by an exploratory measure of IFN-regulated gene expression (interferon signature metric, ISM). Patients (n=238) received rontalizumab (n=159) or placebo (n=79). At baseline, the mean Safety of Estrogens in Lupus Erythematosus National Assessment version of the SLE Disease Activity Index (SELENA-SLEDAI) score in all cohorts was ~10, and 75.6% of patients had a high ISM (ISM-High). Efficacy response rates by BILAG and SRI were similar between rontalizumab and placebo groups. However, in the exploratory subgroup of ISM-Low patients, SRI response was higher and steroid use was lower in the rontalizumab-treated patients. There was also a reduction in SELENA-SLEDAI flare index rates (HR 0.61, 0.46 to 0.81, p=0.004) in this subgroup. Adverse events were similar between placebo and rontalizumab groups. The primary and secondary end points of this trial were not met in all patients or in patients with high ISM scores. In an exploratory analysis, rontalizumab treatment was associated with improvements in disease activity, reduced flares and decreased steroid use in patients with SLE with low ISM scores. NCT00962832. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Palbociclib as single agent or in combination with the endocrine therapy received before disease progression for estrogen receptor-positive, HER2-negative metastatic breast cancer: TREnd trial.

PubMed

Malorni, L; Curigliano, G; Minisini, A M; Cinieri, S; Tondini, C A; D'Hollander, K; Arpino, G; Bernardo, A; Martignetti, A; Criscitiello, C; Puglisi, F; Pestrin, M; Sanna, G; Moretti, E; Risi, E; Biagioni, C; McCartney, A; Boni, L; Buyse, M; Migliaccio, I; Biganzoli, L; Di Leo, A

2018-06-11

The activity of palbociclib as a single agent in advanced breast cancer has not been extensively studied, with the only available clinical data limited to heavily pre-treated patients. Pre-clinical data suggests palbociclib may partially reverse endocrine resistance, though this hypothesis has not been evaluated in previous clinical studies. This phase II, open-label, multi-center study examined the activity of palbociclib monotherapy, as well as palbociclib given in combination with the same endocrine therapy (ET) that was received prior to disease progression, in post-menopausal women with moderately pre-treated, estrogen receptor-positive, HER2 negative advanced breast cancer. Eligible women with advanced disease which had progressed on one or two prior ETs were randomized 1:1 to receive either palbociclib alone, or palbociclib in combination with the ET as previously received. Primary endpoint was clinical benefit rate (CBR); secondary endpoints included progression-free survival (PFS). Between October 2012 and July 2016, a total of 115 patients were randomized. The CBR was 54% (95% CI 41.5 - 63.7) for combination therapy, and 60% (95% CI 47.8 - 72.9) for monotherapy. Median PFS was 10.8 months (95% CI 5.6 - 12.7) for combination therapy, and 6.5 months (95% CI, 5.4 to 8.5) for monotherapy (hazard ratio [HR] 0.69; 95% CI 0.4 - 1.1, exploratory P-value = 0.12). Exploratory analyses revealed the PFS advantage for combination therapy was seen in the subgroup of patients who received prior ET for >6 months (HR 0.53; 95% CI 0.3 - 0.9, exploratory P-value = 0.02), but not in those who received prior ET for ≤6 months. Palbociclib has clinical activity as a single agent in women with moderately pre-treated, oestrogen receptor-positive, HER2-negative advanced breast cancer. Palbociclib may have potential to reverse endocrine resistance in patients with a history of previous durable response to ET. NCT02549430.

Software Reviews.

ERIC Educational Resources Information Center

Teles, Elizabeth, Ed.; And Others

1990-01-01

Reviewed are two computer software packages for Macintosh microcomputers including "Phase Portraits," an exploratory graphics tool for studying first-order planar systems; and "MacMath," a set of programs for exploring differential equations, linear algebra, and other mathematical topics. Features, ease of use, cost, availability, and hardware…

DOE Office of Scientific and Technical Information (OSTI.GOV)

Prescott, Ryan; Marger, Bernard L.; Chiu, Ailsa

During the second iteration of the US NDC Modernization Elaboration phase (E2), the SNL US NDC Modernization project team completed follow-on COTS surveys & exploratory prototyping related to the Object Storage & Distribution (OSD) mechanism, and the processing control software infrastructure. This report summarizes the E2 prototyping work.

Predicted continuum spectra of type II supernovae - LTE results

NASA Technical Reports Server (NTRS)

Shaviv, G.; Wehrse, R.; Wagoner, R. V.

1985-01-01

The continuum spectral energy distribution of the flux emerging from type II supernovae is calculated from quasi-static radiative transfer through a power-law density gradient, assuming radiative equilibrium and LTE. It is found that the Balmer jump disappears at high effective temperatures and low densities, while the spectrum resembles that of a dilute blackbody but is flatter with a sharper cutoff at the short-wavelength end. A significant UV excess is found in all models calculated. The calculation should be considered exploratory because of significant effects which are anticipated to arise from departure from LTE.

An economic and financial exploratory

NASA Astrophysics Data System (ADS)

Cincotti, S.; Sornette, D.; Treleaven, P.; Battiston, S.; Caldarelli, G.; Hommes, C.; Kirman, A.

2012-11-01

This paper describes the vision of a European Exploratory for economics and finance using an interdisciplinary consortium of economists, natural scientists, computer scientists and engineers, who will combine their expertise to address the enormous challenges of the 21st century. This Academic Public facility is intended for economic modelling, investigating all aspects of risk and stability, improving financial technology, and evaluating proposed regulatory and taxation changes. The European Exploratory for economics and finance will be constituted as a network of infrastructure, observatories, data repositories, services and facilities and will foster the creation of a new cross-disciplinary research community of social scientists, complexity scientists and computing (ICT) scientists to collaborate in investigating major issues in economics and finance. It is also considered a cradle for training and collaboration with the private sector to spur spin-offs and job creations in Europe in the finance and economic sectors. The Exploratory will allow Social Scientists and Regulators as well as Policy Makers and the private sector to conduct realistic investigations with real economic, financial and social data. The Exploratory will (i) continuously monitor and evaluate the status of the economies of countries in their various components, (ii) use, extend and develop a large variety of methods including data mining, process mining, computational and artificial intelligence and every other computer and complex science techniques coupled with economic theory and econometric, and (iii) provide the framework and infrastructure to perform what-if analysis, scenario evaluations and computational, laboratory, field and web experiments to inform decision makers and help develop innovative policy, market and regulation designs.

Rotigotine in Combination with the MAO-B Inhibitor Selegiline in Early Parkinson's Disease: A Post Hoc Analysis.

PubMed

Giladi, Nir; Asgharnejad, Mahnaz; Bauer, Lars; Grieger, Frank; Boroojerdi, Babak

2016-04-02

Monoamine oxidase B (MAO-B) inhibitors and dopamine receptor agonists are common first-line treatment options in early Parkinson's disease (PD). To evaluate the efficacy and safety of rotigotine transdermal patch as an add-on therapy to an MAO-B inhibitor in patients with early-PD. In two Phase III, randomized, double-blind, placebo-controlled studies in early-PD (SP512, SP513), patients were randomized to rotigotine (titrated to optimal dose ≤8 mg/24 h) or placebo, and maintained for 24 (SP512) or 33 (SP513) weeks. Post hoc analyses were performed on pooled data for patients receiving an MAO-B inhibitor (selegiline) at a stable dose at randomization and throughout the studies, with groups defined as "Selegiline+Rotigotine" and "Selegiline+Placebo". Outcome measures included change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS) II (activities of daily living), III (motor), UPDRS II+III and responders (patients achieving ≥20%, ≥25% or ≥30% decrease in UPDRS II+III). As post hoc analyses, p-values are exploratory. 130 patients were evaluable for efficacy analyses ("Selegiline+Rotigotine": 84, "Selegiline+Placebo": 46). Combined treatment with rotigotine and selegiline improved UPDRS III and UPDRS II+III scores versus selegiline alone (LS-mean [95% CI] treatment difference for UPDRS III: -4.89 [-7.87 to -1.91], p = 0.0015; for UPDRS II+III: -5.76 [-9.71 to -1.82], p = 0.0045). Higher proportion of patients in the "Selegiline+Rotigotine" group were classified as ≥20%, ≥25% or ≥30% responders (all p < 0.001). Combined treatment appeared more effective in patients aged ≤65 years versus > 65 years (although patient numbers in the subgroups were low). Adverse event profile was consistent with the known safety profile of rotigotine. In these post hoc analyses, adjunctive treatment with rotigotine in patients already receiving an MAO-B inhibitor improved UPDRS II+III score; this appeared to be largely driven by improvements in the motor aspects of PD.

Rotigotine in Combination with the MAO-B Inhibitor Selegiline in Early Parkinson’s Disease: A Post Hoc Analysis

PubMed Central

Giladi, Nir; Asgharnejad, Mahnaz; Bauer, Lars; Grieger, Frank; Boroojerdi, Babak

2016-01-01

Background: Monoamine oxidase B (MAO-B) inhibitors and dopamine receptor agonists are common first-line treatment options in early Parkinson’s disease (PD). Objective: To evaluate the efficacy and safety of rotigotine transdermal patch as an add-on therapy to an MAO-B inhibitor in patients with early-PD. Methods: In two Phase III, randomized, double-blind, placebo-controlled studies in early-PD (SP512, SP513), patients were randomized to rotigotine (titrated to optimal dose ≤8 mg/24 h) or placebo, and maintained for 24 (SP512) or 33 (SP513) weeks. Post hoc analyses were performed on pooled data for patients receiving an MAO-B inhibitor (selegiline) at a stable dose at randomization and throughout the studies, with groups defined as “Selegiline+Rotigotine” and “Selegiline+Placebo”. Outcome measures included change from baseline in Unified Parkinson’s Disease Rating Scale (UPDRS) II (activities of daily living), III (motor), UPDRS II+III and responders (patients achieving ≥20%, ≥25% or ≥30% decrease in UPDRS II+III). As post hoc analyses, p-values are exploratory. Results: 130 patients were evaluable for efficacy analyses (“Selegiline+Rotigotine”: 84, “Selegiline+Placebo”: 46). Combined treatment with rotigotine and selegiline improved UPDRS III and UPDRS II+III scores versus selegiline alone (LS-mean [95% CI] treatment difference for UPDRS III: –4.89 [–7.87 to –1.91], p = 0.0015; for UPDRS II+III: –5.76 [–9.71 to –1.82], p = 0.0045). Higher proportion of patients in the “Selegiline+Rotigotine” group were classified as ≥20%, ≥25% or ≥30% responders (all p < 0.001). Combined treatment appeared more effective in patients aged ≤65 years versus > 65 years (although patient numbers in the subgroups were low). Adverse event profile was consistent with the known safety profile of rotigotine. Conclusions: In these post hoc analyses, adjunctive treatment with rotigotine in patients already receiving an MAO-B inhibitor improved UPDRS II+III score; this appeared to be largely driven by improvements in the motor aspects of PD. PMID:27061066

47 CFR 69.727 - Regulatory relief.

Code of Federal Regulations, 2010 CFR

2010-10-01

... customer. (b) Phase II relief. Upon satisfaction of the Phase II triggers specified in §§ 69.709(c) or 69... Pricing Flexibility § 69.727 Regulatory relief. (a) Phase I relief. Upon satisfaction of the Phase I... similarly situated customers; and (ii) The price cap LEC excludes all contract tariff offerings from price...

47 CFR 90.769 - Construction and implementation of Phase II nationwide licenses.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Use of Frequencies in the 220-222 MHz Band Policies Governing the Licensing and Use of Phase II Ea, Regional and Nationwide Systems § 90.769 Construction and implementation of Phase II nationwide licenses...

Barriers to participation in a phase II cardiac rehabilitation programme.

PubMed

Mak, Y M W; Chan, W K; Yue, C S S

2005-12-01

To identify barriers to participation in a phase II cardiac rehabilitation programme and measures that may enhance participation. Prospective study. Regional hospital, Hong Kong. Cardiac patients recruited for a phase I cardiac rehabilitation programme from July 2002 to January 2003. Reasons for not participating in a phase II cardiac rehabilitation programme. Of the 193 patients recruited for a phase I cardiac rehabilitation programme, 152 (79%) patients, with a mean age of 70.3 years (standard deviation, 11.9 years), did not proceed to phase II programme. Eleven (7%) deaths occurred before commencement of phase II and 74 (49%) patients were considered physically unfit. Reasons for the latter included fractures, pain, or degenerative changes in the lower limbs (24%), and co-morbidities such as cerebrovascular accident (19%), chronic renal failure (11%), congestive heart failure (9%), and unstable angina (8%). Phase II rehabilitation was postponed until after completion of scheduled cardiac interventions in 13% of patients. Failure of physicians to arrange the pre-phase II exercise stress test as per protocol was reported in 7% of patients. Other reasons were reported: work or time conflicts (16%), non-compliance with cardiac treatment (5%), financial constraints (4%), self-exercise (3%), fear after exercise stress testing (3%), and patients returning to their original cardiologists for treatment (3%). A significant (79%) proportion of patients did not proceed to a phase II cardiac rehabilitation programme for a variety of reasons. These included physical unfitness, work or time conflicts, and need to attend scheduled cardiac interventions. Further studies are required to determine how to overcome obstacles to cardiac rehabilitation.

Sundstrand’s Precision Metal Forming Cell. Industrial Modernization Incentive Program (IMIP). Phase 2

DTIC Science & Technology

1991-03-01

1-2 1.4 CONCLUSIONS AND RECOMMENDATIONS ....................... 1-2 20. PHASE II MANAGEMENT PLAN...2-1 2.1 PROGRAM MANAGEMENT ................................... 2-1 2.2 IM IP TEAM...Barbier, reference Section 2.0 (Phase II Management Plan), is complete and this report provides the results of the Phase II study. 1.2 OBJECTIVES The

What Works in Oklahoma Schools: A Comprehensive Needs Assessment of Oklahoma Schools. Phase II State Report

ERIC Educational Resources Information Center

Marzano Research Laboratory, 2010

2010-01-01

Phase II provides a more detailed examination of classroom variables important to achievement in Oklahoma schools. Where Phase I addressed all nine of the Oklahoma essential elements using survey data, Phase II focuses on what occurs in Oklahoma classrooms primarily using data from principal interviews, classroom observations (on-site), and video…

Protecting children from secondhand smoke: a mixed-methods feasibility study of a novel smoke-free home intervention.

PubMed

Marsh, John; McNeill, Ann; Lewis, Sarah; Coleman, Tim; Bains, Manpreet; Larwood, Alexandra; Purdy, Jacqueline; Jones, Laura L

2016-01-01

Globally, 40 % of children under 14 years are regularly exposed to secondhand smoke (SHS), typically in their homes. There is limited evidence of the effectiveness of interventions to reduce children's SHS exposure, and so the aim of this study was to test the feasibility and acceptability of a novel intervention to help parents and carers (caregivers) to reduce their children's exposure to SHS at home. A novel multi-component intervention to support caregivers to reduce their children's SHS exposure at home was tested in a two-phase feasibility study. The 12-week intensive intervention delivered in the home consisted of three components: behavioural support, nicotine replacement therapy (NRT) for temporary abstinence and feedback on levels of SHS exposure in the form of children's salivary cotinine (phase 1) or home air quality (PM 2.5 ) (phase 2). Participants were caregivers who smoked inside their homes and had at least one child under the age of 5 years living with them the majority of the time. Mixed-methods were used to explore the acceptability and feasibility of the intervention as well as processes, particularly around recruitment and retention, for an exploratory efficacy trial. Twelve caregivers completed the study, all received personalised feedback on SHS exposure and behavioural support to help them to make their homes smoke-free and the majority at least tried NRT. Saliva cotinine results were variable in phase 1, and therefore, measures of PM 2.5 were used for feedback in phase 2. Behavioural support was well received with personalised feedback reported as being the key motivator for initiating and maintaining behaviour change. Recruiting disadvantaged caregivers was labour intensive, but once recruited, this novel intervention was both feasible and acceptable in supporting caregivers to reduce their children's exposure to SHS at home. It is appropriate to test the efficacy of this novel intervention in an exploratory randomised controlled trial. This is not applicable for the current study; however, a registered exploratory randomised controlled trial linked to this manuscript is currently ongoing (ISRCTN81701383).

Perceiving the future news: Evidence for retrocausation

NASA Astrophysics Data System (ADS)

Graff, Dale E.; Cyrus, Patricia S.

2017-05-01

Thirty-three exploratory psi investigations were recently performed using Conscious State Psi and Dream State Psi protocols for photographic material that did not exist at the time of the psi sessions. Results would provide evidence for retrocausation if the future photographs had influenced the sessions' data. The psi targets were Associated Press (AP) news photographs published in a Reading, PA area newspaper on a specific page three days in the future. These photographs were taken one day after the psi sessions. Following each psi session, and prior to the photograph's existence, perceptions were recorded in project records and email transmitted for date validation. Feedback was provided when the photograph was published. There were two phases: Phase I was an informal investigation performed by the principle author to evaluate project feasibility. Phase II was a formal investigation with a colleague 1,000 miles from the principle author and the area newspaper location. All data were evaluated by direct comparison to the intended photographs using numerical assessment scales and noting unique features. Data from 21 of the 33 sessions (64%) yielded sketches and narratives with medium and high degrees of correlations with the future news photographs. A subsequent binary analysis using control photographs yielded p = 0.040. Visual informational content of these future newspaper photographs had interacted with the brain's cognitive processes in a retrocausal sense. The future photographs affected the sessions' data. A subconscious interaction between the future and the present or past may be an on-going feature of the mental and physical universe. Suggestions for follow-on investigations into retrocausation are provided.

Exploring the validity and statistical utility of a racism scale among Black men who have sex with men: a pilot study.

PubMed

Smith, William Pastor

2013-09-01

The primary purpose of this two-phased study was to examine the structural validity and statistical utility of a racism scale specific to Black men who have sex with men (MSM) who resided in the Washington, DC, metropolitan area and Baltimore, Maryland. Phase I involved pretesting a 10-item racism measure with 20 Black MSM. Based on pretest findings, the scale was adapted into a 21-item racism scale for use in collecting data on 166 respondents in Phase II. Exploratory factor analysis of the 21-item racism scale resulted in a 19-item, two-factor solution. The two factors or subscales were the following: General Racism and Relationships and Racism. Confirmatory factor analysis was used in testing construct validity of the factored racism scale. Specifically, the two racism factors were combined with three homophobia factors into a confirmatory factor analysis model. Based on a summary of the fit indices, both comparative and incremental were equal to .90, suggesting an adequate convergence of the racism and homophobia dimensions into a single social oppression construct. Statistical utility of the two racism subscales was demonstrated when regression analysis revealed that the gay-identified men versus bisexual-identified men in the sample were more likely to experience increased racism within the context of intimate relationships and less likely to be exposed to repeated experiences of general racism. Overall, the findings in this study highlight the importance of continuing to explore the psychometric properties of a racism scale that accounts for the unique psychosocial concerns experienced by Black MSM.

An Open-label, Phase II Study of the Safety and Tolerability of Pirfenidone in Patients with Scleroderma-associated Interstitial Lung Disease: the LOTUSS Trial.

PubMed

Khanna, Dinesh; Albera, Carlo; Fischer, Aryeh; Khalidi, Nader; Raghu, Ganesh; Chung, Lorinda; Chen, Dan; Schiopu, Elena; Tagliaferri, Margit; Seibold, James R; Gorina, Eduard

2016-09-01

Systemic sclerosis-associated interstitial lung disease (SSc-ILD) shares a number of clinical features and pathogenic mechanisms with idiopathic pulmonary fibrosis (IPF). This study was designed to evaluate the tolerability of the IPF treatment pirfenidone in SSc-ILD. The known gastrointestinal, skin, and liver adverse events (AE) of pirfenidone are of importance given the involvement of these organs in SSc. All patients received pirfenidone and were randomized 1:1 to either a 2- or 4-week titration starting at 801 mg/day and finishing at a maintenance dose of 2403 mg/day. Patients received pirfenidone for 16 weeks in total. Assessments included treatment-emergent AE (TEAE) and exploratory disease outcomes. Sixty-three patients were randomized; 96.8% experienced a TEAE and more patients reported TEAE during the titration versus the maintenance period. The most commonly reported TEAE were consistent with those observed for pirfenidone in IPF (nausea, headache, fatigue) and were similar regardless of titration schedule. More patients discontinued treatment because of TEAE in the 2- versus 4-week titration group (5 vs 1, respectively); all discontinuation events occurred > 3 weeks after reaching the full dose of pirfenidone. Mycophenolate mofetil (MMF), taken by 63.5% of patients in addition to pirfenidone, did not appear to affect tolerability. Exploratory disease outcomes remained largely unchanged. Pirfenidone showed an acceptable tolerability profile in SSc-ILD, although a longer titration may be associated with better tolerability. Tolerability was not affected by concomitant MMF. The present findings support further investigation of pirfenidone in future clinical trials in patients with SSc-ILD. ClinicalTrials.gov; www.clinicaltrials.gov NCT01933334.

Alabama Coronary Artery Bypass Grafting Project

PubMed Central

Holman, William L.; Sansom, Monique; Kiefe, Catarina I.; Peterson, Eric D.; Hubbard, Steve G.; Delong, James F.; Allman, Richard M.

2004-01-01

Objective/Background: This report describes the first round of results for Phase II of the Alabama CABG Project, a regional quality improvement initiative. Methods: Charts submitted by all hospitals in Alabama performing CABG (ICD-9 codes 36.10–36.20) were reviewed by a Clinical Data Abstraction Center (CDAC) (preintervention 1999–2000; postintervention 2000–2001). Variables that described quality in Phase I were abstracted for Phase II and data describing the new variables of β-blocker use and lipid management were collected. Data samples collected onsite by participating hospitals were used for rapid cycle improvement in Phase II. Results: CDAC data (n = 1927 cases in 1999; n = 2001 cases in 2000) showed that improvements from Phase I in aspirin prescription, internal mammary artery use, and duration of intubation persisted in Phase II. During Phase II, use of β-blockers before, during, or after CABG increased from 65% to 76% of patients (P < 0.05). Appropriate lipid management, an aggregate variable, occurred in 91% of patients before and 91% after the educational intervention. However, there were improvements in 3 of 5 subcategories for lipid management (documenting a lipid disorder [52%–57%], initiating drug therapy [45%–53%], and dietary counseling [74%–91%]; P < 0.05). Conclusions: In Phase II, this statewide process-oriented quality improvement program added two new measures of quality. Achievements of quality improvement from Phase I persisted in Phase II, and improvements were seen in the new variables of lipid management and perioperative use of β-blockers. PMID:14685107

Electric Utility Phase I Acid Rain Compliance Strategies for the Clean Air Act Amendments of 1990

EIA Publications

1994-01-01

The Acid Rain Program is divided into two time periods; Phase I, from 1995 through 1999, and Phase II, starting in 2000. Phase I mostly affects power plants that are the largest sources of SO2 and NOx . Phase II affects virtually all electric power producers, including utilities and nonutilities. This report is a study of the effects of compliance with Phase I regulations on the costs and operations of electric utilities, but does not address any Phase II impacts.

Durability of lightweight concrete : Phase II : wetting and drying tests, Phase III : freezing and thawing tests.

DOT National Transportation Integrated Search

1966-12-01

This report describes a laboratory research program on the durability of lightweight concrete. Two phases of a three phase study are covered by this report, while the remaining phase is still under study. The two phases being reported are Phase II - ...

Ion Conduction Path and Low-Temperature Form:. Argyrodite-Type Superionic Conductors

NASA Astrophysics Data System (ADS)

Onoda, M.; Wada, H.; Sato, A.; Ishii, M.

2007-01-01

The structures of the orthorhombic room-temperature phase of Cu8GeS6 (phase II) and the monoclinic low-temperature phase of Ag7TaS6 (phase II) have been successfully refined based on X-ray diffraction data from 12-fold twinned (Cu8GeS6 II) and 24-fold twinned (Ag7TaS6 II) crystals. Respectively among 6 major and 6 minor twin domains of Cu8GeS6 II, or among 12 major and 12 minor twin domains of Ag7TaS6 II, the argyrodite-type frameworks, GeS6 or TaS6, can be superposed to each other in principle, and only Cu-Cu or Ag-Ag network directions differ. At higher temperature, the crystals were considered to be 2-fold twinned crystals of superionic-conductor phase I with a space group F 43m. On cooling, each domain transforms into 6 domains of orthorhombic Cu8GeS6 II or 12 domains of monoclinic Ag7TaS6 II. Superposed projections along 6 directions of the structure of Cu8GeS6 II and along 12 directions of the structure of Ag7TaS6 II seem to show approximate expressions for Cu-ion and Ag-ion conduction paths in superionic-conductor phases, Cu8GeS6 I and Ag7TaS6I.

Estimates of general combining ability in Hevea breeding at the Rubber Research Institute of Malaysia : I. Phases II and III A.

PubMed

Tan, H

1977-01-01

Estimates of general combining ability of parents for yield and girth obtained separately from seedlings and their corresponding clonal families in Phases II and IIIA of the RRIM breeding programme are compared. A highly significant positive correlation (r = 0.71***) is found between GCA estimates from seedling and clonal families for yield in Phase IIIA, but not in Phase II (r = -0.03(NS)) nor for girth (r= -0.27(NS)) in Phase IIIA. The correlations for Phase II yield and Phase IIIA girth, however, improve when the GCA estimates based on small sample size or reversed rankings are excluded.When the best selections (based on present clonal and seedling information) are compared, all five of the parents top-ranking for yield are common in Phase IIIA but only two parents are common for yield and girth in Phases II and IIIA respectively. However, only one parent for yield in Phase II and two parents for girth in Phase IIIA would, if selected on clonal performance, have been omitted from the top ranking selections made by previous workers using seedling information.These findings, therefore, justify the choice of parents based on GCA estimates for yield obtained from seedling performance. Similar justification cannot be offered for girth, for which analysis is confounded by uninterpretable site and seasonal effects.

Benzocaine polymorphism: pressure-temperature phase diagram involving forms II and III.

PubMed

Gana, Inès; Barrio, Maria; Do, Bernard; Tamarit, Josep-Lluís; Céolin, René; Rietveld, Ivo B

2013-11-18

Understanding the phase behavior of an active pharmaceutical ingredient in a drug formulation is required to avoid the occurrence of sudden phase changes resulting in decrease of bioavailability in a marketed product. Benzocaine is known to possess three crystalline polymorphs, but their stability hierarchy has so far not been determined. A topological method and direct calorimetric measurements under pressure have been used to construct the topological pressure-temperature diagram of the phase relationships between the solid phases II and III, the liquid, and the vapor phase. In the process, the transition temperature between solid phases III and II and its enthalpy change have been determined. Solid phase II, which has the highest melting point, is the more stable phase under ambient conditions in this phase diagram. Surprisingly, solid phase I has not been observed during the study, even though the scarce literature data on its thermal behavior appear to indicate that it might be the most stable one of the three solid phases. Copyright © 2013 Elsevier B.V. All rights reserved.

ASR-9 processor augmentation card (9-PAC) phase II scan-scan correlator algorithms

DOT National Transportation Integrated Search

2001-04-26

The report documents the scan-scan correlator (tracker) algorithm developed for Phase II of the ASR-9 Processor Augmentation Card (9-PAC) project. The improved correlation and tracking algorithms in 9-PAC Phase II decrease the incidence of false-alar...

Optimising text messaging to improve adherence to web-based smoking cessation treatment: a randomised control trial protocol.

PubMed

Graham, Amanda L; Jacobs, Megan A; Cohn, Amy M; Cha, Sarah; Abroms, Lorien C; Papandonatos, George D; Whittaker, Robyn

2016-03-30

Millions of smokers use the Internet for smoking cessation assistance each year; however, most smokers engage minimally with even the best designed websites. The ubiquity of mobile devices and their effectiveness in promoting adherence in other areas of health behaviour change make them a promising tool to address adherence in Internet smoking cessation interventions. Text messaging is used by most adults, and messages can proactively encourage use of a web-based intervention. Text messaging can also be integrated with an Internet intervention to facilitate the use of core Internet intervention components. We identified four aspects of a text message intervention that may enhance its effectiveness in promoting adherence to a web-based smoking cessation programme: personalisation, integration, dynamic tailoring and message intensity. Phase I will use a two-level full factorial design to test the impact of these four experimental features on adherence to a web-based intervention. The primary outcome is a composite metric of adherence that incorporates general utilisation metrics (eg, logins, page views) and specific feature utilisation shown to predict abstinence. Participants will be N=860 adult smokers who register on an established Internet cessation programme and enrol in its text message programme. Phase II will be a two-arm randomised trial to compare the efficacy of the web-based cessation programme alone and in conjunction with the optimised text messaging intervention on 30-day point prevalence abstinence at 9 months. Phase II participants will be N=600 adult smokers who register to use an established Internet cessation programme and enrol in text messaging. Secondary analyses will explore whether adherence mediates the effect of treatment condition on outcome. This protocol was approved by Chesapeake IRB. We will disseminate study results through peer-reviewed manuscripts and conference presentations related to the methods and design, outcomes and exploratory analyses. NCT02585206. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of dignity therapy for older people in care homes: study protocol.

PubMed

Hall, Sue; Chochinov, Harvey; Harding, Richard; Murray, Scott; Richardson, Alison; Higginson, Irene J

2009-03-24

Although most older people living in nursing homes die there, there is a dearth of robust evaluations of interventions to improve their end-of-life care. Residents usually have multiple health problems making them heavily reliant on staff for their care, which can erode their sense of dignity. Dignity Therapy has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting has suggested that Dignity Therapy is beneficial to people dying of cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people reaching the end of life in care homes, and to pilot the methods for a Phase III RCT. A randomised controlled open-label trial. Sixty-four residents of care homes for older people are randomly allocated to one of two groups: (i) Intervention (Dignity Therapy offered in addition to any standard care), and (ii) Control group (standard care). Recipients of the "generativity" documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and eight weeks after the intervention (equivalent in the control group). The primary outcome is residents' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory. Secondary outcomes for residents include depression, hopefulness and quality of life. In view of the relatively small sample size, quantitative analysis is mainly descriptive. The qualitative analysis uses the Framework method. Dignity Therapy is brief, can be done at the bedside and could help both patients and their families. This detailed exploratory research shows if it is feasible to offer Dignity Therapy to residents of care homes, whether it is acceptable to them, their families and care home staff, if it is likely to be effective, and determine whether a Phase III RCT is desirable. Current Controlled Clinical Trials: ISRCTN37589515.

PROMETHEE II: A knowledge-driven method for copper exploration

NASA Astrophysics Data System (ADS)

Abedi, Maysam; Ali Torabi, S.; Norouzi, Gholam-Hossain; Hamzeh, Mohammad; Elyasi, Gholam-Reza

2012-09-01

This paper describes the application of a well-known Multi Criteria Decision Making (MCDM) technique called Preference Ranking Organization METHod for Enrichment Evaluation (PROMETHEE II) to explore porphyry copper deposits. Various raster-based evidential layers involving geological, geophysical, and geochemical geo-datasets are integrated to prepare a mineral prospectivity mapping (MPM). In a case study, thirteen layers of the Now Chun copper deposit located in the Kerman province of Iran are used to explore the region of interest. The PROMETHEE II technique is applied to produce the desired MPM, and the outputs are validated using twenty-one boreholes that have been classified into five classes. This proposed method shows a high performance when providing the MPM while reducing the cost of exploratory drilling in the study area.

Mechanisms of blood pressure alterations in response to the Valsalva maneuver in postural tachycardia syndrome

NASA Technical Reports Server (NTRS)

Sandroni, P.; Novak, V.; Opfer-Gehrking, T. L.; Huck, C. A.; Low, P. A.

2000-01-01

The postural tachycardia syndrome (POTS) is characterized clinically by orthostatic lightheadedness and tachycardia. When these patients perform a Valsalva maneuver, there is an excessive blood pressure increment after cessation of the maneuver (phase IV) that is sometimes associated with headaches. It is not known whether excessive phase IV is due to excessive peripheral vascular tone (an alpha-adrenergic mechanism) or is a manifestation of increased beta-adrenergic tone (hyperadrenergic state). The authors undertook a pharmacologic study evaluating the effect of intravenous phentolamine (alpha-adrenergic antagonist) and propranolol (beta-adrenergic antagonist) on the different phases of the Valsalva maneuver in a group of patients with POTS and age-matched normal control subjects. Patients with POTS had mean phases, when compared with controls, that were characterized by more negative II_E (p = 0.07), smaller II_L (p = 0.04), and significantly larger phase IV (p = 0.001). The effect of phentolamine was qualitatively and quantitatively different in POTS when compared with controls. Ten mg phentolamine in controls resulted in a significant accentuation of phase II_E (p = 0.001), attenuation of phase II_L (p = 0.002), and increase of phase IV (57.6 vs 30.7 mm Hg; p = 0.025). These changes resembled those of patients with POTS at baseline. In patients with POTS, the phase II abnormalities, already present, were further accentuated (p <0.001), and phase IV became smaller (50.6 vs 73.8 mm Hg; p = 0.09). Propranolol had no significant effect on phases II_E and II_L, but significantly reduced phase IV in both controls (p <0.05) and in patients with POTS (p <0.001) and improved the headache symptoms, when present, during and after phase IV. The authors conclude that phase IV is mainly under beta-adrenergic regulation and that the exaggerated phase IV in POTS is a result of a hyperadrenergic state.

Measurement of Loneliness Among Clients Representing Four Stages of Cancer: An Exploratory Study.

DTIC Science & Technology

1985-03-01

status, and membership in organizations for each client were entered into a SPSS program in a mainframe computer . The means and a one-way analysis of...Study 6. PERFORMING ORG. REPORT NUMBER 7. AUTHOR(e) S. CONTRACT OR GRANT NUMBER(&) Suanne Smith 9. PERFORMING ORGANIZATION NAME AND ADDRESS 10. PROGRAM ...27 Definitions of Terms .......... . . . . 28 II. MErODOLOGY . . . . . . . . . . ......... 30 Overviev of Design

Teaching Robust Methods for Exploratory Data Analysis.

DTIC Science & Technology

1980-10-01

of adding a new point x to a sample x1*9...sX n* The Influence Function of the estimate 0 at the value x is defined to be For example, if 0 is the...mean (Ex )/n, we can calculate II+(x,iZ) x-ix Plotting I+, ’I- -9- we see that the mean has an unbounded Influence Function , and is therefore not robust

TNX GeoSiphon Cell (TGSC-1) Phase II Single Cell Deployment/Demonstration Final Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Phifer, M.A.

1999-04-15

This Phase II final report documents the Phase II testing conducted from June 18, 1998 through November 13, 1998, and it focuses on the application of the siphon technology as a sub-component of the overall GeoSiphon Cell technology. [Q-TPL-T-00004

40 CFR 72.44 - Phase II repowering extensions.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Compliance Plan and Compliance Options § 72.44 Phase II repowering... the requirements of paragraph (a)(1)(i) of this section may include in the unit's Phase II Acid Rain... authority shall issue the Acid Rain portion of the operating permit including: (A) The approved repowering...

40 CFR 72.44 - Phase II repowering extensions.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Compliance Plan and Compliance Options § 72.44 Phase II repowering... the requirements of paragraph (a)(1)(i) of this section may include in the unit's Phase II Acid Rain... authority shall issue the Acid Rain portion of the operating permit including: (A) The approved repowering...

40 CFR 72.44 - Phase II repowering extensions.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Compliance Plan and Compliance Options § 72.44 Phase II repowering... the requirements of paragraph (a)(1)(i) of this section may include in the unit's Phase II Acid Rain... authority shall issue the Acid Rain portion of the operating permit including: (A) The approved repowering...

40 CFR 72.44 - Phase II repowering extensions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Compliance Plan and Compliance Options § 72.44 Phase II repowering... the requirements of paragraph (a)(1)(i) of this section may include in the unit's Phase II Acid Rain... authority shall issue the Acid Rain portion of the operating permit including: (A) The approved repowering...

40 CFR 72.44 - Phase II repowering extensions.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Compliance Plan and Compliance Options § 72.44 Phase II repowering... the requirements of paragraph (a)(1)(i) of this section may include in the unit's Phase II Acid Rain... authority shall issue the Acid Rain portion of the operating permit including: (A) The approved repowering...

First results of GERDA Phase II and consistency with background models

NASA Astrophysics Data System (ADS)

Agostini, M.; Allardt, M.; Bakalyarov, A. M.; Balata, M.; Barabanov, I.; Baudis, L.; Bauer, C.; Bellotti, E.; Belogurov, S.; Belyaev, S. T.; Benato, G.; Bettini, A.; Bezrukov, L.; Bode1, T.; Borowicz, D.; Brudanin, V.; Brugnera, R.; Caldwell, A.; Cattadori, C.; Chernogorov, A.; D'Andrea, V.; Demidova, E. V.; Di Marco, N.; Domula, A.; Doroshkevich, E.; Egorov, V.; Falkenstein, R.; Frodyma, N.; Gangapshev, A.; Garfagnini, A.; Gooch, C.; Grabmayr, P.; Gurentsov, V.; Gusev, K.; Hakenmüller, J.; Hegai, A.; Heisel, M.; Hemmer, S.; Hofmann, W.; Hult, M.; Inzhechik, L. V.; Janicskó Csáthy, J.; Jochum, J.; Junker, M.; Kazalov, V.; Kihm, T.; Kirpichnikov, I. V.; Kirsch, A.; Kish, A.; Klimenko, A.; Kneißl, R.; Knöpfle, K. T.; Kochetov, O.; Kornoukhov, V. N.; Kuzminov, V. V.; Laubenstein, M.; Lazzaro, A.; Lebedev, V. I.; Lehnert, B.; Liao, H. Y.; Lindner, M.; Lippi, I.; Lubashevskiy, A.; Lubsandorzhiev, B.; Lutter, G.; Macolino, C.; Majorovits, B.; Maneschg, W.; Medinaceli, E.; Miloradovic, M.; Mingazheva, R.; Misiaszek, M.; Moseev, P.; Nemchenok, I.; Palioselitis, D.; Panas, K.; Pandola, L.; Pelczar, K.; Pullia, A.; Riboldi, S.; Rumyantseva, N.; Sada, C.; Salamida, F.; Salathe, M.; Schmitt, C.; Schneider, B.; Schönert, S.; Schreiner, J.; Schulz, O.; Schütz, A.-K.; Schwingenheuer, B.; Selivanenko, O.; Shevzik, E.; Shirchenko, M.; Simgen, H.; Smolnikov, A.; Stanco, L.; Vanhoefer, L.; Vasenko, A. A.; Veresnikova, A.; von Sturm, K.; Wagner, V.; Wegmann, A.; Wester, T.; Wiesinger, C.; Wojcik, M.; Yanovich, E.; Zhitnikov, I.; Zhukov, S. V.; Zinatulina, D.; Zuber, K.; Zuzel, G.

2017-01-01

The GERDA (GERmanium Detector Array) is an experiment for the search of neutrinoless double beta decay (0νββ) in 76Ge, located at Laboratori Nazionali del Gran Sasso of INFN (Italy). GERDA operates bare high purity germanium detectors submersed in liquid Argon (LAr). Phase II of data-taking started in Dec 2015 and is currently ongoing. In Phase II 35 kg of germanium detectors enriched in 76Ge including thirty newly produced Broad Energy Germanium (BEGe) detectors is operating to reach an exposure of 100 kg·yr within about 3 years data taking. The design goal of Phase II is to reduce the background by one order of magnitude to get the sensitivity for T1/20ν = O≤ft( {{{10}26}} \\right){{ yr}}. To achieve the necessary background reduction, the setup was complemented with LAr veto. Analysis of the background spectrum of Phase II demonstrates consistency with the background models. Furthermore 226Ra and 232Th contamination levels consistent with screening results. In the first Phase II data release we found no hint for a 0νββ decay signal and place a limit of this process T1/20ν > 5.3 \\cdot {1025} yr (90% C.L., sensitivity 4.0·1025 yr). First results of GERDA Phase II will be presented.

Phase-0/microdosing studies using PET, AMS, and LC-MS/MS: a range of study methodologies and conduct considerations. Accelerating development of novel pharmaceuticals through safe testing in humans - a practical guide.

PubMed

Burt, Tal; John, Christy S; Ruckle, Jon L; Vuong, Le T

2017-05-01

Phase-0 studies, including microdosing, also called Exploratory Investigational New Drug (eIND) or exploratory clinical trials, are a regulatory framework for first-in-human (FIH) trials. Common to these approaches is the use and implied safety of limited exposures to test articles. Use of sub-pharmacological doses in phase-0/microdose studies requires sensitive analytic tools such as accelerator mass spectrometer (AMS), Positron Emission Tomography (PET), and Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) to determine drug disposition. Areas covered: Here we present a practical guide to the range of methodologies, design options, and conduct strategies that can be used to increase the efficiency of drug development. We provide detailed examples of relevant developmental scenarios. Expert opinion: Validation studies over the past decade demonstrated the reliability of extrapolation of sub-pharmacological to therapeutic-level exposures in more than 80% of cases, an improvement over traditional allometric approaches. Applications of phase-0/microdosing approaches include study of pharmacokinetic and pharmacodynamic properties, target tissue localization, drug-drug interactions, effects in vulnerable populations (e.g. pediatric), and intra-target microdosing (ITM). Study design should take into account the advantages and disadvantages of each analytic tool. Utilization of combinations of these analytic techniques increases the versatility of study designs and the power of data obtained.

Disorganized Symptoms Predicted Worse Functioning Outcome in Schizophrenia Patients with Established Illness.

PubMed

Ortiz, Bruno Bertolucci; Gadelha, Ary; Higuchi, Cinthia Hiroko; Noto, Cristiano; Medeiros, Daiane; Pitta, José Cássio do Nascimento; de Araújo Filho, Gerardo Maria; Hallak, Jaime Eduardo Cecílio; Bressan, Rodrigo Affonseca

Most patients with schizophrenia will have subsequent relapses of the disorder, with continuous impairments in functioning. However, evidence is lacking on how symptoms influence functioning at different phases of the disease. This study aims to investigate the relationship between symptom dimensions and functioning at different phases: acute exacerbation, nonremission and remission. Patients with schizophrenia were grouped into acutely ill (n=89), not remitted (n=89), and remitted (n=69). Three exploratory stepwise linear regression analyses were performed for each phase of schizophrenia, in which the five PANSS factors and demographic variables were entered as the independent variables and the total Global Assessment of Functioning Scale (GAF) score was entered as the dependent variable. An additional exploratory stepwise logistic regression analysis was performed to predict subsequent remission at discharge in the inpatient population. The Disorganized factor was the most significant predictor for acutely ill patients (p<0.001), while the Hostility factor was the most significant for not-remitted patients and the Negative factor was the most significant for remitted patients (p=0.001 and p<0.001, respectively). In the logistic regression, the Disorganized factor score presented a significant negative association with remission (p=0.007). Higher disorganization symptoms showed the greatest impact in functioning at acute phase, and prevented patients from achieving remission, suggesting it may be a marker of symptom severity and worse outcome in schizophrenia.

Cross-cultural validation of instruments measuring health beliefs about colorectal cancer screening among Korean Americans.

PubMed

Lee, Shin-Young; Lee, Eunice E

2015-02-01

The purpose of this study was to report the instrument modification and validation processes to make existing health belief model scales culturally appropriate for Korean Americans (KAs) regarding colorectal cancer (CRC) screening utilization. Instrument translation, individual interviews using cognitive interviewing, and expert reviews were conducted during the instrument modification phase, and a pilot test and a cross-sectional survey were conducted during the instrument validation phase. Data analyses of the cross-sectional survey included internal consistency and construct validity using exploratory and confirmatory factor analysis. The main issues identified during the instrument modification phase were (a) cultural and linguistic translation issues and (b) newly developed items reflecting Korean cultural barriers. Cross-sectional survey analyses during the instrument validation phase revealed that all scales demonstrate good internal consistency reliability (Cronbach's alpha=.72~.88). Exploratory factor analysis showed that susceptibility and severity loaded on the same factor, which may indicate a threat variable. Items with low factor loadings in the confirmatory factor analysis may relate to (a) lack of knowledge about fecal occult blood testing and (b) multiple dimensions of the subscales. Methodological, sequential processes of instrument modification and validation, including translation, individual interviews, expert reviews, pilot testing and a cross-sectional survey, were provided in this study. The findings indicate that existing instruments need to be examined for CRC screening research involving KAs.

The Development and Psychometric Properties of the Immigration Law Concerns Scale (ILCS) for HIV Testing.

PubMed

Lechuga, Julia; Galletly, Carol L; Broaddus, Michelle R; Dickson-Gomez, Julia B; Glasman, Laura R; McAuliffe, Timothy L; Vega, Miriam Y; LeGrand, Sarah; Mena, Carla A; Barlow, Morgan L; Valera, Erik; Montenegro, Judith I

2017-11-08

To develop, pilot test, and conduct psychometric analyses of an innovative scale measuring the influence of perceived immigration laws on Latino migrants' HIV-testing behavior. The Immigration Law Concerns Scale (ILCS) was developed in three phases: Phase 1 involved a review of law and literature, generation of scale items, consultation with project advisors, and subsequent revision of the scale. Phase 2 involved systematic translation- back translation and consensus-based editorial processes conducted by members of a bilingual and multi-national study team. In Phase 3, 339 sexually active, HIV-negative Spanish-speaking, non-citizen Latino migrant adults (both documented and undocumented) completed the scale via audio computer-assisted self-interview. The psychometric properties of the scale were tested with exploratory factor analysis and estimates of reliability coefficients were generated. Bivariate correlations were conducted to test the discriminant and predictive validity of identified factors. Exploratory factor analysis revealed a three-factor, 17-item scale. subscale reliability ranged from 0.72 to 0.79. There were significant associations between the ILCS and the HIV-testing behaviors of participants. Results of the pilot test and psychometric analysis of the ILCS are promising. The scale is reliable and significantly associated with the HIV-testing behaviors of participants. Subscales related to unwanted government attention and concerns about meeting moral character requirements should be refined.

A modified Delphi study towards developing a guideline to inform policy on fetal alcohol spectrum disorders in South Africa: a study protocol

PubMed Central

Mukumbang, Ferdinand C; Okop, Kufre J; Beytell, Anna-Marie

2018-01-01

Introduction Maternal alcohol consumption during pregnancy can result in mental and physical birth defects in individuals. These birth defects are usually described as fetal alcohol spectrum disorders (FASDs). With an estimated 183–259 per 1000 children born with FASDs, South Africa is identified to have the highest prevalence of FASDs in the world. Nevertheless, there is a lack of appropriate policies, guidelines and interventions addressing the issues around FASDs. This protocol outlines a proposed process for developing a guideline to inform policies on FASDs. Methods and analysis This process will have three phases. Phase I will be carried out in three steps; we plan to conduct a document review of available policies on the prevention and management of FASDs and update the existing systematic review on FASDs interventions. The aim of the two reviews is to explore the availability and content of existing policies and global interventions on FASDs. In addition, we will conduct two exploratory qualitative studies to obtain the perspectives of various stakeholders on the existing or possible guidelines and policies for the management of FASDs and available interventions and services. In phase II, we will aggregate the findings of the previous phase to develop a prototype guideline. In phase III, using the developed prototype, we will apply the Delphi approach with experts on FASDs, soliciting their opinions on the nature and content of the proposed guidelines for policies. The information gathered will be used to modify the prototype to formulate a policy guideline on FASDs. The data will be analysed using thematic analysis and narrative synthesis. Ethics and dissemination Ethical clearance has been obtained from the ethics committee of the university and governmental departments. The findings will be disseminated through publications and the guideline will be submitted to relevant departments. PMID:29703853

Efficacy and safety of rifaximin in Japanese patients with hepatic encephalopathy: A phase II/III, multicenter, randomized, evaluator-blinded, active-controlled trial and a phase III, multicenter, open trial.

PubMed

Suzuki, Kazuyuki; Endo, Ryujin; Takikawa, Yasuhiro; Moriyasu, Fuminori; Aoyagi, Yutaka; Moriwaki, Hisataka; Terai, Shuji; Sakaida, Isao; Sakai, Yoshiyuki; Nishiguchi, Shuhei; Ishikawa, Toru; Takagi, Hitoshi; Naganuma, Atsushi; Genda, Takuya; Ichida, Takafumi; Takaguchi, Koichi; Miyazawa, Katsuhiko; Okita, Kiwamu

2018-05-01

The efficacy and safety of rifaximin in the treatment of hepatic encephalopathy (HE) are widely known, but they have not been confirmed in Japanese patients with HE. Thus, two prospective, randomized studies (a phase II/III study and a phase III study) were carried out. Subjects with grade I or II HE and hyperammonemia were enrolled. The phase II/III study, which was a randomized, evaluator-blinded, active-comparator, parallel-group study, was undertaken at 37 institutions in Japan. Treatment periods were 14 days. Eligible patients were randomized to the rifaximin group (1200 mg/day) or the lactitol group (18-36 g/day). The phase III study was carried out in the same patients previously enrolled in the phase II/III study, and they were all treated with rifaximin (1200 mg/day) for 10 weeks. In the phase II/III study, 172 patients were enrolled. Blood ammonia (B-NH 3 ) concentration was significantly improved in the rifaximin group, but the difference between the two groups was not significant. The portal systemic encephalopathy index (PSE index), including HE grade, was significantly improved in both groups. In the phase III study, 87.3% of enrolled patients completed the treatment. The improved B-NH 3 concentration and PSE index were well maintained from the phase II/III study during the treatment period of the phase III study. Adverse drug reactions (ADRs) were seen in 13.4% of patients who received rifaximin, but there were no severe ADRs leading to death. The efficacy of rifaximin is sufficient and treatment is well tolerated in Japanese patients with HE and hyperammonemia. © 2017 The Japan Society of Hepatology.

Phenomenology of Polymorphism, III: p, TDiagram and Stability of Piracetam Polymorphs

NASA Astrophysics Data System (ADS)

Céolin, R.; Agafonov, V.; Louër, D.; Dzyabchenko, V. A.; Toscani, S.; Cense, J. M.

1996-02-01

The nootropic drug Piracetam is known to crystallize in three phases. In order to obtain their stability hierarchy from sublimation pressure inequalities, the drawing of a topologicalp,Tdiagram was attempted. For such a purpose and also for quality control, crystallographic and thermodynamic data were required. Powder X-ray diffractometry (XRD) and differential scanning calorimetry (DSC) were used. Molecular energy calculations were performed. Phase I melts at 426 K (ΔfusH(I) = +180 J·g-1). Phase II transforms into Phase I at 399 K (Δ(II→I)H= +24 J·g-1). Phase III transforms into phase I at 392 K (Δ(III→I)H= +28 J·g-1) or melts at 412 K (ΔfusH(III) = +210 J·g-1). Thep,Tdiagram shows that phase I is stable at higher temperature and phase II at lower temperature, like phase III, which is stable under high pressure. At room temperature, phase II is the more stable form, and phase I the less stable one. This agrees with the spontaneous I → II transformation observed at 298 K within a few hours, and with lattice energies, calculated previously. Molecular energy calculations and crystal structure comparison show how intermolecular hydrogen bonds and H-bonded dimers, in phases II and III, may stabilize conformations higher in energy than those of the isolated molecule and of phase I.

Benefits and Sustainability of a Learning Collaborative for Implementation of Treat to Target in Rheumatoid Arthritis: Results of the TRACTION Trial Phase II.

PubMed

Solomon, Daniel H; Lu, Bing; Yu, Zhi; Corrigan, Cassandra; Harrold, Leslie R; Smolen, Josef S; Fraenkel, Liana; Katz, Jeffrey N; Losina, Elena

2018-01-05

We conducted a two-phase randomized controlled trial of a Learning Collaborative (LC) to facilitate implementation of treat to target (TTT) to manage rheumatoid arthritis (RA). We found substantial improvement in implementation of TTT in Phase I. Herein, we report on a second 9 months (Phase II) where we examined maintenance of response in Phase I and predictors of greater improvement in TTT adherence. We recruited 11 rheumatology sites and randomized them to either receive the LC during Phase I or to a wait-list control group that received the LC intervention during Phase II. The outcome was change in TTT implementation score (0 to 100, 100 is best) from pre- to post-intervention. TTT implementation score is defined as a percent of components documented in visit notes. Analyses examined: 1) the extent that the Phase I intervention teams sustained improvement in TTT; and, 2) predictors of TTT improvement. The analysis included 636 RA patients. At baseline, mean TTT implementation score was 11% in Phase I intervention sites and 13% in Phase II sites. After the intervention, TTT implementation score improved to 57% in the Phase I intervention sites and to 58% in the Phase II sites. Intervention sites from Phase I sustained the improvement during the Phase II (52%). Predictors of greater TTT improvement included only having rheumatologist providers at the site, academic affiliation of the site, fewer providers per site, and the rheumatologist provider being a trainee. Improvement in TTT remained relatively stable over a post-intervention period. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Cellulose-lanthanum hydroxide nanocomposite as a selective marker for detection of toxic copper

PubMed Central

2014-01-01

In this current report, a simple, reliable, and rapid method based on modifying the cellulose surface by doping it with different percentages of lanthanum hydroxide (i.e., 1% La(OH)3-cellulose (LC), 5% La(OH)3-cellulose (LC2), and 10% La(OH)3-cellulose (LC3)) was proposed as a selective marker for detection of copper (Cu(II)) in aqueous medium. Surface properties of the newly modified cellulose phases were confirmed by Fourier transform infrared spectroscopy, field emission scanning electron microscope, energy dispersive X-ray spectroscopy, X-ray diffraction, and X-ray photoelectron spectroscopic analysis. The effect of pH on the adsorption of modified cellulose phases for Cu(II) was evaluated, and LC3 was found to be the most selective for Cu(II) at pH 6.0. Other parameters, influencing the maximum uptake of Cu(II) on LC3, were also investigated for a deeper mechanistic understanding of the adsorption phenomena. Results showed that the adsorption capacity for Cu(II) was improved by 211% on the LC3 phase as compared to diethylaminoethyl cellulose phase after only 2 h contact time. Adsorption isotherm data established that the adsorption process nature was monolayer with a homogeneous adsorbent surface. Results displayed that the adsorption of Cu(II) onto the LC3 phase obeyed a pseudo-second-order kinetic model. Selectivity studies toward eight metal ions, i.e., Cd(II), Co(II), Cr(III), Cr(VI), Cu(II), Fe(III), Ni(II), and Zn(II), were further performed at the optimized pH value. Based on the selectivity study, it was found that Cu(II) is highly selective toward the LC3 phase. Moreover, the efficiency of the proposed method was supported by implementing it to real environmental water samples with adequate results. PMID:25258599

MECHANISM AND KINETICS OF THE FORMATION OF NOX AND OTHER COMBUSTION POLLUTANTS. PHASE II. MODIFIED COMBUSTION

EPA Science Inventory

The report gives Phase II results of a combined experimental/theoretical study to define the mechanisms and kinetics of the formation of NOx and other combustion pollutants. Two experimental devices were used in Phase II. A special flat-flame burner with a controlled-temperature ...

76 FR 3624 - Milford Wind Corridor Phase II, LLC; Supplemental Notice That Initial Market-Based Rate Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-20

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER11-2657-000] Milford Wind Corridor Phase II, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for... proceeding Milford Wind Corridor Phase II, LLC's application for market-based rate authority, with an...

40 CFR 72.73 - State issuance of Phase II permits.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.73 State issuance of Phase II permits... permit program under part 70 of this chapter and that has a State Acid Rain program accepted by the Administrator under § 72.71 shall be responsible for administering and enforcing Acid Rain permits effective in...

40 CFR 72.73 - State issuance of Phase II permits.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.73 State issuance of Phase II permits... permit program under part 70 of this chapter and that has a State Acid Rain program accepted by the Administrator under § 72.71 shall be responsible for administering and enforcing Acid Rain permits effective in...

40 CFR 72.73 - State issuance of Phase II permits.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.73 State issuance of Phase II permits... permit program under part 70 of this chapter and that has a State Acid Rain program accepted by the Administrator under § 72.71 shall be responsible for administering and enforcing Acid Rain permits effective in...

40 CFR 72.73 - State issuance of Phase II permits.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.73 State issuance of Phase II permits... permit program under part 70 of this chapter and that has a State Acid Rain program accepted by the Administrator under § 72.71 shall be responsible for administering and enforcing Acid Rain permits effective in...

40 CFR 72.74 - Federal issuance of Phase II permits.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROGRAMS (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.74 Federal issuance of Phase II permits. (a)(1) The Administrator will be responsible for administering and enforcing Acid Rain... and enforcing Acid Rain permits for such sources under § 72.73(a). (2) After and to the extent the...

40 CFR 72.74 - Federal issuance of Phase II permits.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PROGRAMS (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.74 Federal issuance of Phase II permits. (a)(1) The Administrator will be responsible for administering and enforcing Acid Rain... and enforcing Acid Rain permits for such sources under § 72.73(a). (2) After and to the extent the...

40 CFR 72.74 - Federal issuance of Phase II permits.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PROGRAMS (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.74 Federal issuance of Phase II permits. (a)(1) The Administrator will be responsible for administering and enforcing Acid Rain... and enforcing Acid Rain permits for such sources under § 72.73(a). (2) After and to the extent the...

40 CFR 72.74 - Federal issuance of Phase II permits.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PROGRAMS (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.74 Federal issuance of Phase II permits. (a)(1) The Administrator will be responsible for administering and enforcing Acid Rain... and enforcing Acid Rain permits for such sources under § 72.73(a). (2) After and to the extent the...

40 CFR 72.73 - State issuance of Phase II permits.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.73 State issuance of Phase II permits... permit program under part 70 of this chapter and that has a State Acid Rain program accepted by the Administrator under § 72.71 shall be responsible for administering and enforcing Acid Rain permits effective in...

40 CFR 72.74 - Federal issuance of Phase II permits.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROGRAMS (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.74 Federal issuance of Phase II permits. (a)(1) The Administrator will be responsible for administering and enforcing Acid Rain... and enforcing Acid Rain permits for such sources under § 72.73(a). (2) After and to the extent the...

Doping-induced disappearance of ice II from water's phase diagram

NASA Astrophysics Data System (ADS)

Shephard, Jacob J.; Slater, Ben; Harvey, Peter; Hart, Martin; Bull, Craig L.; Bramwell, Steven T.; Salzmann, Christoph G.

2018-06-01

Water and the many phases of ice display a plethora of complex physical properties and phase relationships1-4 that are of paramount importance in a range of settings including processes in Earth's hydrosphere, the geology of icy moons, industry and even the evolution of life. Well-known examples include the unusual behaviour of supercooled water2, the emergent ferroelectric ordering in ice films4 and the fact that the `ordinary' ice Ih floats on water. We report the intriguing observation that ice II, one of the high-pressure phases of ice, disappears in a selective fashion from water's phase diagram following the addition of small amounts of ammonium fluoride. This finding exposes the strict topologically constrained nature of the ice II hydrogen-bond network, which is not found for the competing phases. In analogy to the behaviour of frustrated magnets5, the presence of the exceptional ice II is argued to have a wider impact on water's phase diagram, potentially explaining its general tendency to display anomalous behaviour. Furthermore, the impurity-induced disappearance of ice II raises the prospect that specific dopants may not only be able to suppress certain phases but also induce the formation of new phases of ice in future studies.

Assessment of Operational Automated Guideway Systems - Airtrans (Phase II)

DOT National Transportation Integrated Search

1980-01-01

This study, Phase II, completes the assessment of AIRTRANS, the automated guideway system located at the Dallas-Fort Worth Airport. The Phase I assessment report: "Assessment of Operational Automated Guideway Systems--AIRTRANS (Phase I)" (PB-261 339)...

Efficacy and safety of luseogliflozin monotherapy in Japanese patients with type 2 diabetes mellitus: a 12-week, randomized, placebo-controlled, phase II study.

PubMed

Seino, Yutaka; Sasaki, Takashi; Fukatsu, Atsushi; Sakai, Soichi; Samukawa, Yoshishige

2014-07-01

Luseogliflozin is a novel sodium glucose cotransporter 2 inhibitor for type 2 diabetes mellitus (T2DM) treatment. An exploratory Phase II study was conducted to assess the efficacy and safety of several doses of luseogliflozin in Japanese T2DM patients. Japanese T2DM patients aged 20-74 years with hemoglobin A1c (HbA1c) of 6.9-10.5%, fasting plasma glucose (FPG) ≥126 mg/dL and on diet therapy were randomized in a double-blind manner to receive luseogliflozin (0.5, 2.5, or 5 mg) or placebo once daily for 12 weeks (n = 61, 61, 61, and 56, respectively). The primary endpoint was the change in HbA1c from baseline to end of treatment. Other endpoints included FPG, 2 h postprandial plasma glucose (PPG) in a meal tolerance test (MTT), and body weight. Drug safety was also assessed. Japan Pharmaceutical Information Center (identifier: JapicCTI-090908). Changes in HbA1c from baseline to end of treatment were -0.36, -0.62, and -0.75% in the 0.5, 2.5, and 5 mg luseogliflozin groups, respectively, versus +0.06% in the placebo group (all P < 0.001). The reductions in FPG and 2 h-PPG in the MTT were also significantly greater in the luseogliflozin groups (all P < 0.01) without increases in insulin levels from baseline. Luseogliflozin reduced body weight at all doses. There were no significant differences in the incidences of adverse events among groups. Most adverse events were mild in severity. There were no serious adverse events. Although this was a small-scale study with a short duration, all tested doses of luseogliflozin significantly improved glycemic control, reduced body weight, and were well tolerated in Japanese T2DM patients over the 12-week treatment period.

TBCRC 019: A Phase II Trial of Nanoparticle Albumin-Bound Paclitaxel with or without the Anti-Death Receptor 5 Monoclonal Antibody Tigatuzumab in Patients with Triple-Negative Breast Cancer.

PubMed

Forero-Torres, Andres; Varley, Katherine E; Abramson, Vandana G; Li, Yufeng; Vaklavas, Christos; Lin, Nancy U; Liu, Minetta C; Rugo, Hope S; Nanda, Rita; Storniolo, Anna M; Traina, Tiffany A; Patil, Sujata; Van Poznak, Catherine H; Nangia, Julie R; Irvin, William J; Krontiras, Helen; De Los Santos, Jennifer F; Haluska, Paul; Grizzle, William; Myers, Richard M; Wolff, Antonio C

2015-06-15

Tigatuzumab (TIG), an agonistic anti-DR5 antibody, triggers apoptosis in DR5(+) human tumor cells without crosslinking. TIG has strong in vitro/in vivo activity against basal-like breast cancer cells enhanced by chemotherapy agents. This study evaluates activity of TIG and chemotherapy in patients with metastatic triple-negative breast cancer (TNBC). Randomized 2:1 phase II trial of albumin-bound paclitaxel (nab-PAC) ± TIG in patients with TNBC stratified by prior chemotherapy. Patients received nab-PAC weekly × 3 ± TIG every other week, every 28 days. Primary objective was within-arm objective response rate (ORR). Secondary objectives were safety, progression-free survival (PFS), clinical benefit, and TIG immunogenicity. Metastatic research biopsies were required. Among 64 patients (60 treated; TIG/nab-PAC n = 39 and nab-PAC n = 21), there were 3 complete remissions (CR), 8 partial remissions (PR; 1 almost CR), 11 stable diseases (SD), and 17 progressive diseases (PD) in the TIG/nab-PAC arm (ORR, 28%), and no CRs, 8 PRs, 4 SDs, and 9 PDs in the nab-PAC arm (ORR, 38%). There was a numerical increase in CRs and several patients had prolonged PFS (1,025+, 781, 672, 460, 334) in the TIG/nab-PAC arm. Grade 3 toxicities were 28% and 29%, respectively, with no grade 4-5. Exploratory analysis suggests an association of ROCK1 gene pathway activation with efficacy in the TIG/nab-PAC arm. ORR and PFS were similar in both. Preclinical activity of TIG in basal-like breast cancer and prolonged PFS in few patients in the combination arm support further investigation of anti-DR5 agents. ROCK pathway activation merits further evaluation. ©2015 American Association for Cancer Research.

Dynamic molecular analysis and clinical correlates of tumor evolution within a phase II trial of panitumumab-based therapy in metastatic colorectal cancer.

PubMed

Siena, S; Sartore-Bianchi, A; Garcia-Carbonero, R; Karthaus, M; Smith, D; Tabernero, J; Van Cutsem, E; Guan, X; Boedigheimer, M; Ang, A; Twomey, B; Bach, B A; Jung, A S; Bardelli, A

2018-01-01

Mutations in rat sarcoma (RAS) genes may be a mechanism of secondary resistance in epidermal growth factor receptor inhibitor-treated patients. Tumor-tissue biopsy testing has been the standard for evaluating mutational status; however, plasma testing of cell-free DNA has been shown to be a more sensitive method for detecting clonal evolution. Archival pre- and post-treatment tumor biopsy samples from a phase II study of panitumumab in combination with irinotecan in patients with metastatic colorectal cancer (mCRC) that also collected plasma samples before, during, and after treatment were analyzed for emergence of mutations during/post-treatment by next-generation sequencing and BEAMing. The rate of emergence of tumor tissue RAS mutations was 9.5% by next-generation sequencing (n = 21) and 6.3% by BEAMing (n = 16). Plasma testing of cell-free DNA by BEAMing revealed a mutant RAS emergence rate of 36.7% (n = 39). Exploratory outcomes analysis of plasma samples indicated that patients who had emergent RAS mutations at progression had similar median progression-free survival to those patients who remained wild-type at progression. Serial analysis of plasma samples showed that the first detected emergence of RAS mutations preceded progression by a median of 3.6 months (range, -0.3 to 7.5 months) and that there did not appear to be a mutant RAS allele frequency threshold that could predict near-term outcomes. This first prospective analysis in mCRC showed that serial plasma biopsies are more inclusive than tissue biopsies for evaluating global tumor heterogeneity; however, the clinical utility of plasma testing in mCRC remains to be further explored. NCT00891930. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Secondary Professional Socialization through Professional Organizations: An Exploratory Study

ERIC Educational Resources Information Center

Richards, K. Andrew; Eberline, Andrew D.; Templin, Thomas J.

2016-01-01

Secondary professional socialization is a phase of occupational socialization theory that focuses on graduate education in preparation for a career in academia. Due to the need to present and publish research and make professional contacts, professional organizations likely serve an important socializing function during graduate education. The…

Twitter Use in Libraries: An Exploratory Analysis

ERIC Educational Resources Information Center

Aharony, Noa

2010-01-01

Microblogging is a relatively new phenomenon in online social networking that has become increasingly prevalent in the last few years. This study explores the use of Twitter in public and academic libraries to understand microblogging patterns. Analysis of the tweets was conducted in two phases: (1) statistical descriptive analysis and (2) content…

Attendance at specialist hepatitis clinics and initiation of antiviral treatment among persons chronically infected with hepatitis C: examining the early impact of Scotland's Hepatitis C Action Plan.

PubMed

McDonald, S A; Hutchinson, S J; Innes, H A; Allen, S; Bramley, P; Bhattacharyya, D; Carman, W; Dillon, J F; Fox, R; Fraser, A; Goldberg, D J; Kennedy, N; Mills, P R; Morris, J; Stanley, A J; Wilks, D; Hayes, P C

2014-05-01

Primary goals of the Hepatitis C Action Plan for Scotland Phase II (May 2008-March 2011) were to increase, among persons chronically infected with the hepatitis C (HCV) virus, attendance at specialist outpatient clinics and initiation on antiviral therapy. We evaluated progress towards these goals by comparing the odds, across time, of (a) first clinic attendance within 12 months of HCV diagnosis (n = 9747) and (b) initiation on antiviral treatment within 12 months of first attendance (n = 5736). Record linkage between the national HCV diagnosis (1996-2009) and HCV clinical (1996-2010) databases and logistic regression analyses were conducted for both outcomes. For outcome (a), 32% and 45% in the respective pre-Phase II (before 1 May 2008) and Phase II periods attended a specialist clinic within 12 months of diagnosis; the odds of attendance within 12 months increased over time (OR = 1.05 per year, 95% CI: 1.04-1.07), but was not significantly greater for persons diagnosed with HCV in the Phase II era, compared with the pre-Phase II era (OR = 1.1, 95% CI: 0.9-1.3), after adjustment for temporal trend. For outcome (b), 13% and 28% were initiated on treatment within 12 months of their first clinic attendance in the pre-Phase II and Phase II periods, respectively. Higher odds of treatment initiation were associated with first clinic attendance in the Phase II (OR = 1.9, 95% CI: 1.5-2.4), compared with the pre-Phase II era. Results were consistent with a positive impact of the Hepatitis C Action Plan on the treatment of chronically infected individuals, but further monitoring is required to confirm a sustained effect. © 2013 John Wiley & Sons Ltd.

Maximizing return on socioeconomic investment in phase II proof-of-concept trials.

PubMed

Chen, Cong; Beckman, Robert A

2014-04-01

Phase II proof-of-concept (POC) trials play a key role in oncology drug development, determining which therapeutic hypotheses will undergo definitive phase III testing according to predefined Go-No Go (GNG) criteria. The number of possible POC hypotheses likely far exceeds available public or private resources. We propose a design strategy for maximizing return on socioeconomic investment in phase II trials that obtains the greatest knowledge with the minimum patient exposure. We compare efficiency using the benefit-cost ratio, defined to be the risk-adjusted number of truly active drugs correctly identified for phase III development divided by the risk-adjusted total sample size in phase II and III development, for different POC trial sizes, powering schemes, and associated GNG criteria. It is most cost-effective to conduct small POC trials and set the corresponding GNG bars high, so that more POC trials can be conducted under socioeconomic constraints. If δ is the minimum treatment effect size of clinical interest in phase II, the study design with the highest benefit-cost ratio has approximately 5% type I error rate and approximately 20% type II error rate (80% power) for detecting an effect size of approximately 1.5δ. A Go decision to phase III is made when the observed effect size is close to δ. With the phenomenal expansion of our knowledge in molecular biology leading to an unprecedented number of new oncology drug targets, conducting more small POC trials and setting high GNG bars maximize the return on socioeconomic investment in phase II POC trials. ©2014 AACR.

Development of advanced blanket performance under irradiation and system integration through JUPITER-II project

DOE Office of Scientific and Technical Information (OSTI.GOV)

Abe, Katsunori; Kohyama, Akira; Tanaka, Satoru

This report describes an outline of the activities of the JUPITER-II collaboration (japan-USA program of Irradiation/Integration test for Fusion Research-II), Which has bee carried out through six years (2001-2006) under Phase 4 of the collabroation implemented by Amendment 4 of Annex 1 to the DOE (United States Department of Energy)-MEXT (Ministry of Education ,Culture,Sports,Science and Technology) Cooperation. This program followed the RTNS-II Program (Phase1:1982-4986), the FFTF/MOTA Program (Phase2:1987-1994) and the JUPITER Program (Phase 3: 1995-2000) [1].

Upgrade for Phase II of the Gerda experiment

NASA Astrophysics Data System (ADS)

Agostini, M.; Bakalyarov, A. M.; Balata, M.; Barabanov, I.; Baudis, L.; Bauer, C.; Bellotti, E.; Belogurov, S.; Belyaev, S. T.; Benato, G.; Bettini, A.; Bezrukov, L.; Bode, T.; Borowicz, D.; Brudanin, V.; Brugnera, R.; Caldwell, A.; Cattadori, C.; Chernogorov, A.; D'Andrea, V.; Demidova, E. V.; Di Marco, N.; Domula, A.; Doroshkevich, E.; Egorov, V.; Falkenstein, R.; Frodyma, N.; Gangapshev, A.; Garfagnini, A.; Grabmayr, P.; Gurentsov, V.; Gusev, K.; Hakenmüller, J.; Hegai, A.; Heisel, M.; Hemmer, S.; Hiller, R.; Hofmann, W.; Hult, M.; Inzhechik, L. V.; Ioannucci, L.; Janicskó Csáthy, J.; Jochum, J.; Junker, M.; Kazalov, V.; Kermaïdic, Y.; Kihm, T.; Kirpichnikov, I. V.; Kirsch, A.; Kish, A.; Klimenko, A.; Kneißl, R.; Knöpfle, K. T.; Kochetov, O.; Kornoukhov, V. N.; Kuzminov, V. V.; Laubenstein, M.; Lazzaro, A.; Lebedev, V. I.; Lehnert, B.; Lindner, M.; Lippi, I.; Lubashevskiy, A.; Lubsandorzhiev, B.; Lutter, G.; Macolino, C.; Majorovits, B.; Maneschg, W.; Medinaceli, E.; Miloradovic, M.; Mingazheva, R.; Misiaszek, M.; Moseev, P.; Nemchenok, I.; Nisi, S.; Panas, K.; Pandola, L.; Pelczar, K.; Pullia, A.; Ransom, C.; Riboldi, S.; Rumyantseva, N.; Sada, C.; Salamida, F.; Salathe, M.; Schmitt, C.; Schneider, B.; Schönert, S.; Schreiner, J.; Schütz, A.-K.; Schulz, O.; Schwingenheuer, B.; Selivanenko, O.; Shevchik, E.; Shirchenko, M.; Simgen, H.; Smolnikov, A.; Stanco, L.; Vanhoefer, L.; Vasenko, A. A.; Veresnikova, A.; von Sturm, K.; Wagner, V.; Wegmann, A.; Wester, T.; Wiesinger, C.; Wojcik, M.; Yanovich, E.; Zhitnikov, I.; Zhukov, S. V.; Zinatulina, D.; Zsigmond, A. J.; Zuber, K.; Zuzel, G.

2018-05-01

The Gerda collaboration is performing a sensitive search for neutrinoless double beta decay of ^{76}Ge at the INFN Laboratori Nazionali del Gran Sasso, Italy. The upgrade of the Gerda experiment from Phase I to Phase II has been concluded in December 2015. The first Phase II data release shows that the goal to suppress the background by one order of magnitude compared to Phase I has been achieved. Gerda is thus the first experiment that will remain "background-free" up to its design exposure (100 kg year). It will reach thereby a half-life sensitivity of more than 10^{26} year within 3 years of data collection. This paper describes in detail the modifications and improvements of the experimental setup for Phase II and discusses the performance of individual detector components.

40 CFR 80.45 - Complex emissions model.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) VOCW% = Percentage change in winter VOC emissions from baseline levels (8) Phase II total VOC emissions... its domain Phase I = The years 1995-1999 Phase II = Year 2000 and beyond (b) Weightings and baselines... appropriate pollutant and Phase: Table 1—Normal and Higher Emitter Weightings for Exhaust Emissions Phase I...

Learning new gait patterns: Exploratory muscle activity during motor learning is not predicted by motor modules

PubMed Central

Ranganathan, Rajiv; Krishnan, Chandramouli; Dhaher, Yasin Y.; Rymer, William Z.

2018-01-01

The motor module hypothesis in motor control proposes that the nervous system can simplify the problem of controlling a large number of muscles in human movement by grouping muscles into a smaller number of modules. Here, we tested one prediction of the modular organization hypothesis by examining whether there is preferential exploration along these motor modules during the learning of a new gait pattern. Healthy college-aged participants learned a new gait pattern which required increased hip and knee flexion during the swing phase while walking in a lower-extremity robot (Lokomat). The new gait pattern was displayed as a foot trajectory in the sagittal plane and participants attempted to match their foot trajectory to this template. We recorded EMG from 8 lower-extremity muscles and we extracted motor modules during both baseline walking and target-tracking using non-negative matrix factorization (NMF). Results showed increased trajectory variability in the first block of learning, indicating that participants were engaged in exploratory behavior. Critically, when we examined the muscle activity during this exploratory phase, we found that the composition of motor modules changed significantly within the first few strides of attempting the new gait pattern. The lack of persistence of the motor modules under even short time scales suggests that motor modules extracted during locomotion may be more indicative of correlated muscle activity induced by the task constraints of walking, rather than reflecting a modular control strategy. PMID:26916510

Defense Small Business Innovation Research (SBIR) Program. Program Solicitation 90.1. FY-1990

DTIC Science & Technology

1989-10-01

Electronics Assemble and Test A90-125 Guided-Wave TeO2 Optical Devices A90-126 Acceleration Sensing Module for Munition Safety Systems A90-127 Electromagnetic...package containing all drawings and process information, complete operating manuals. A90-125 Guided-Wave TeO2 Optical Devices OBJECTIVE: This exploratory...bandwidth and efficiency of these devices. PHASE I: Phase one would consist of the design of several breadboard TeO2 AO devices each having TBWP of

Chesapeake Bay Low Freshwater Inflow Study. Phase II. MAP FOLIO. Biota Assessment.

DTIC Science & Technology

1982-05-01

conditions. These were: 1) Base Average -- average freshwater inflow conditions. by increased water consumption projected for the year 2020. 3) Base Drought...RESOLUTION TEST CHART NATIONAL BUREAU OF STANDARDS. 1963- A TAI m - ii J May 1982 Chesapeake Bay Low Freshwater Inflow Study Phase II Biota Assessment Map...A PERIOD ZOVERED change was found to CIESAPEAKE BAY LOW FRESHWATER INFLOW STUDY FINAL BIOTA ASSESSMENT PHASE II: FINAL REPORT MAP FOLIO s PERFORMING

Effects of Combined Phase III and Phase II Cardiac Exercise Therapy for Middle-aged Male Patients with Acute Myocardial Infarction

PubMed Central

Lee, Chih-Wei; Wang, Ji-Hung; Hsieh, Jen-Che; Hsieh, Tsung-Cheng; Huang, Chien-Hui

2013-01-01

[Purpose] To investigate the effects of cardiac exercise therapy (CET) on exercise capacity and coronary risk factors (CRFs) of patients with acute myocardial infarction (AMI). [Methods] Patients who participated in an 8-week supervised, hospital-based phase II and 6-month home-based phase III CET with monthly telephone and/or home visits were defined as the exercise group (EG) (n=20), while those who did not receive phase II or phase III CET were defined as the no-exercise group (NEG) (n=10). CRFs were evaluated pre- and post-phase II and eight months after discharge. One and two-way repeated measures ANOVA were used to perform intra- and inter-group comparisons. [Results] Thirty men with AMI aged 49.3 ± 8.3 years were studied. EG increased their exercise capacity (METs) (6.8 ± 1.6 vs.10.0 ± 1.9) after phase II CET and was able to maintain it at 8-month follow-up. Both groups had significantly fewer persons who kept on smoking compared to the first examination. High density lipoprotein cholesterol (HDL-C) increased from 38.1 ± 11.0 to 43.7 ± 8.7 mg/dl at follow-up in EG while no significant difference was noted in NEG. [Conclusion] After phase III CET subjects had maintained the therapeutic effects of smoking cessation, and increasing exercise capacity obtained in phase II CET. HDL-C in EG continued to improve during phase III CET. PMID:24396201

47 CFR 54.310 - Connect America Fund for Price Cap Territories-Phase II

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 3 2014-10-01 2014-10-01 false Connect America Fund for Price Cap Territories... Connect America Fund for Price Cap Territories—Phase II (a) Geographic areas eligible for support. Connect America Phase II support may be made available for census blocks or other areas identified as eligible by...

Phase I/II adaptive design for drug combination oncology trials

PubMed Central

Wages, Nolan A.; Conaway, Mark R.

2014-01-01

Existing statistical methodology on dose finding for combination chemotherapies has focused on toxicity considerations alone in finding a maximum tolerated dose combination to recommend for further testing of efficacy in a phase II setting. Recently, there has been increasing interest in integrating phase I and phase II trials in order to facilitate drug development. In this article, we propose a new adaptive phase I/II method for dual-agent combinations that takes into account both toxicity and efficacy after each cohort inclusion. The primary objective, both within and at the conclusion of the trial, becomes finding a single dose combination with an acceptable level of toxicity that maximizes efficacious response. We assume that there exist monotone dose–toxicity and dose–efficacy relationships among doses of one agent when the dose of other agent is fixed. We perform extensive simulation studies that demonstrate the operating characteristics of our proposed approach, and we compare simulated results to existing methodology in phase I/II design for combinations of agents. PMID:24470329

Raman Frequencies Calculated from the Volume Data as a Function of Temperature at High Pressures for the Disordered Phase II of NH4I

NASA Astrophysics Data System (ADS)

Yurtseven, H.; Kavruk, D.

In this study, we calculate the Raman frequencies as a function of temperature for the fixed pressures of 706, 1080 and 6355 bars using the volume data for phase II of ammonium iodide. The Raman frequencies calculated here are for the translational optic ν5 TOM (125 cm-1) lattice mode that is located at the zone boundary (M point) of the Brillouin zone of phase II for NH4I. For this calculation the volume data obtained at zero pressure, is used through the mode Grüneisen parameter for the disordered phase II (β phase) which has the CsCl structure of NH4I. Our predicted frequencies of the ν5 TOM (125 cm-1) mode can be compared when the Raman data for this lattice mode is available at various temperatures for fixed pressures of 706, 1080 and 6355 bars in the disordered phase II of ammonium iodide.

Work-related experiences of head and neck cancer survivors: an exploratory and descriptive qualitative study.

PubMed

Dewa, Carolyn S; Trojanowski, Lucy; Tamminga, Sietske J; Ringash, Jolie; McQuestion, Maurene; Hoch, Jeffrey S

2018-06-01

This exploratory and descriptive study contributes to the growing knowledge about the return-to-work (RTW) experience of head and neck cancer (HNC) survivors. Viewing RTW as a process, participants were asked to consider the work-related experience with HNC at different phases: (1) at diagnosis/pre-treatment, (2) working during treatment (if the respondent did not take a work disability leave), and (3) post-treatment/RTW (if the respondent took a work disability leave). Data were gathered in nine individual semi-structured in-depth interviews with patients receiving treatment at a quaternary cancer center's HNC clinic in Ontario, Canada. Using a constant comparative method of theme development, codes were identified in and derived from the data. Codes with similar characteristics were grouped, used to develop overarching themes, and were organized according to the RTW factors identified in the literature. Each phase has different barriers that are in turn addressed by different facilitators. As reflected in the literature, we found that RTW or the process of work continuation is complex. Many players and interactions contribute to the worker's experience. By recognizing that work-related experiences differ by phases, clinicians and employers can better support HNC survivors depending on the phase of the RTW process. Implications for Rehabilitation Our findings suggest that when rehabilitation specialists are working with survivors to develop interventions, the return-to-work phase and work context rather than diagnosis should be considered as a starting point. At every phase, supportive and empathetic managers are a key to successful work experiences for people who have been diagnosed and are being treated for head and neck cancer. Rehabilitation specialists should help survivors to seek supportive interactions with the environment that are essential to enable the ability to work.

Tecemotide in unresectable stage III non-small-cell lung cancer in the phase III START study: updated overall survival and biomarker analyses.

PubMed

Mitchell, P; Thatcher, N; Socinski, M A; Wasilewska-Tesluk, E; Horwood, K; Szczesna, A; Martín, C; Ragulin, Y; Zukin, M; Helwig, C; Falk, M; Butts, C; Shepherd, F A

2015-06-01

Tecemotide is a MUC1-antigen-specific cancer immunotherapy. The phase III START study did not meet its primary end point but reported notable survival benefit with tecemotide versus placebo in an exploratory analysis of the predefined patient subgroup treated with concurrent chemoradiotherapy. Here, we attempted to gain further insight into the effects of tecemotide in START. START recruited patients who did not progress following frontline chemoradiotherapy for unresectable stage III non-small-cell lung cancer. We present updated overall survival (OS) data and exploratory analyses of OS for baseline biomarkers: soluble MUC1 (sMUC1), antinuclear antibodies (ANA), neutrophil/lymphocyte ratio (NLR), lymphocyte count, and HLA type. Updated OS data are consistent with the primary analysis: median 25.8 months (tecemotide) versus 22.4 months (placebo) (HR 0.89, 95% CI 0.77-1.03, P = 0.111), with ∼20 months additional median follow-up time compared with the primary analysis. Exploratory analysis of the predefined subgroup treated with concurrent chemoradiotherapy revealed clinically relevant prolonged OS with tecemotide versus placebo (29.4 versus 20.8 months; HR 0.81, 95% CI 0.68-0.98, P = 0.026). No improvement was seen with sequential chemoradiotherapy. High sMUC1 and ANA correlated with a possible survival benefit with tecemotide (interaction P = 0.0085 and 0.0022) and might have future value as biomarkers. Interactions between lymphocyte count, NLR, or prespecified HLA alleles and treatment effect were not observed. Updated OS data support potential treatment benefit with tecemotide in patients treated with concurrent chemoradiotherapy. Exploratory biomarker analyses suggest that elevated sMUC1 or ANA levels correlate with tecemotide benefit. NCT00409188. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

A Physics Exploratory Experiment on Plasma Liner Formation

NASA Technical Reports Server (NTRS)

Thio, Y. C. Francis; Knapp, Charles E.; Kirkpatrick, Ronald C.; Siemon, Richard E.; Turchi, Peter

2002-01-01

Momentum flux for imploding a target plasma in magnetized target fusion (MTF) may be delivered by an array of plasma guns launching plasma jets that would merge to form an imploding plasma shell (liner). In this paper, we examine what would be a worthwhile experiment to do in order to explore the dynamics of merging plasma jets to form a plasma liner as a first step in establishing an experimental database for plasma-jets driven magnetized target fusion (PJETS-MTF). Using past experience in fusion energy research as a model, we envisage a four-phase program to advance the art of PJETS-MTF to fusion breakeven Q is approximately 1). The experiment (PLX (Plasma Liner Physics Exploratory Experiment)) described in this paper serves as Phase I of this four-phase program. The logic underlying the selection of the experimental parameters is presented. The experiment consists of using twelve plasma guns arranged in a circle, launching plasma jets towards the center of a vacuum chamber. The velocity of the plasma jets chosen is 200 km/s, and each jet is to carry a mass of 0.2 mg - 0.4 mg. A candidate plasma accelerator for launching these jets consists of a coaxial plasma gun of the Marshall type.

Neonicotinoids Interfere with Specific Components of Navigation in Honeybees

PubMed Central

Fischer, Johannes; Müller, Teresa; Spatz, Anne-Kathrin; Greggers, Uwe; Grünewald, Bernd; Menzel, Randolf

2014-01-01

Three neonicotinoids, imidacloprid, clothianidin and thiacloprid, agonists of the nicotinic acetylcholine receptor in the central brain of insects, were applied at non-lethal doses in order to test their effects on honeybee navigation. A catch-and-release experimental design was applied in which feeder trained bees were caught when arriving at the feeder, treated with one of the neonicotinoids, and released 1.5 hours later at a remote site. The flight paths of individual bees were tracked with harmonic radar. The initial flight phase controlled by the recently acquired navigation memory (vector memory) was less compromised than the second phase that leads the animal back to the hive (homing flight). The rate of successful return was significantly lower in treated bees, the probability of a correct turn at a salient landscape structure was reduced, and less directed flights during homing flights were performed. Since the homing phase in catch-and-release experiments documents the ability of a foraging honeybee to activate a remote memory acquired during its exploratory orientation flights, we conclude that non-lethal doses of the three neonicotinoids tested either block the retrieval of exploratory navigation memory or alter this form of navigation memory. These findings are discussed in the context of the application of neonicotinoids in plant protection. PMID:24646521

Development and psychometric evaluation of a women shift workers' reproductive health questionnaire: study protocol for a sequential exploratory mixed-method study.

PubMed

Nikpour, Maryam; Tirgar, Aram; Ebadi, Abbas; Ghaffari, Fatemeh; Firouzbakht, Mojgan; Hajiahmadi, Mahmod

2018-02-06

Although shift works is a certain treat for female reproductive health, but currently, there is no standardized instrument for measuring reproductive health among female shift workers. This study aims to develop and evaluate the psychometric properties of a Women Shift Workers' Reproductive Health Questionnaire (WSW-RHQ). This is a sequential exploratory mixed-method study with a qualitative and a quantitative phase. In the qualitative phase, semi-structured interviews will be held with female shift workers who live in Mazandaran Province, Iran, additionally, the literature review will be performed by searching electronic databases. Sampling will be done in different workplaces and with maximum variation respecting female shift workers' age and job and educational and different economic situation. Interview data will be analyzed using conventional content analysis and then, the primary item pool for the questionnaire will be developed. In the quantitative phase, we will evaluate the psychometric properties of the questionnaire, i.e. its face, content, construct as well as reliability via the internal consistency, stability. Finally, a scoring system will be developed for the questionnaire. The development of WSW-RHQ will facilitate the promotion and implementation of reproductive health interventions and assessment of their effectiveness. Other scholars can cross-culturally adapt and use the questionnaire according to their immediate contexts.

The National Geographic Names Data Base: Phase II instructions

USGS Publications Warehouse

Orth, Donald J.; Payne, Roger L.

1987-01-01

not recorded on topographic maps be added. The systematic collection of names from other sources, including maps, charts, and texts, is termed Phase II. In addition, specific types of features not compiled during Phase I are encoded and added to the data base. Other names of importance to researchers and users, such as historical and variant names, are also included. The rules and procedures for Phase II research, compilation, and encoding are contained in this publication.

Effects of Heat Generation on Nuclear Waste Disposal in Salt

NASA Astrophysics Data System (ADS)

Clayton, D. J.

2008-12-01

Disposal of nuclear waste in salt is an established technology, as evidenced by the successful operations of the Waste Isolation Pilot Plant (WIPP) since 1999. The WIPP is located in bedded salt in southeastern New Mexico and is a deep underground facility for transuranic (TRU) nuclear waste disposal. There are many advantages for placing radioactive wastes in a geologic bedded-salt environment. One desirable mechanical characteristic of salt is that it flows plastically with time ("creeps"). The rate of salt creep is a strong function of temperature and stress differences. Higher temperatures and deviatoric stresses increase the creep rate. As the salt creeps, induced fractures may be closed and eventually healed, which then effectively seals the waste in place. With a backfill of crushed salt emplaced around the waste, the salt creep can cause the crushed salt to reconsolidate and heal to a state similar to intact salt, serving as an efficient seal. Experiments in the WIPP were conducted to investigate the effects of heat generation on the important phenomena and processes in and around the repository (Munson et al. 1987; 1990; 1992a; 1992b). Brine migration towards the heaters was induced from the thermal gradient, while salt creep rates showed an exponential dependence on temperature. The project "Backfill and Material Behavior in Underground Salt Repositories, Phase II" (BAMBUS II) studied the crushed salt backfill and material behavior with heat generation at the Asse mine located near Remlingen, Germany (Bechthold et al. 2004). Increased salt creep rates and significant reconsolidation of the crushed salt were observed at the termination of the experiment. Using the data provided from both projects, exploratory modeling of the thermal-mechanical response of salt has been conducted with varying thermal loading and waste spacing. Increased thermal loading and decreased waste spacing drive the system to higher temperatures, while both factors are desired to reduce costs, as well as decrease the overall footprint of the repository. Higher temperatures increase the rate of salt creep which then effectively seals the waste quicker. Data of the thermal-mechanical response of salt at these higher temperatures is needed to further validate the exploratory modeling and provide meaningful constraints on the repository design. Sandia is a multi program laboratory operated by Sandia Corporation, a Lockheed Martin Company, for the United States Department of Energy's National Nuclear Security Administration under Contract DE-AC04- 94AL85000.

Mixed response and time-to-event endpoints for multistage single-arm phase II design.

PubMed

Lai, Xin; Zee, Benny Chung-Ying

2015-06-04

The objective of phase II cancer clinical trials is to determine if a treatment has sufficient activity to warrant further study. The efficiency of a conventional phase II trial design has been the object of considerable debate, particularly when the study regimen is characteristically cytostatic. At the time of development of a phase II cancer trial, we accumulated clinical experience regarding the time to progression (TTP) for similar classes of drugs and for standard therapy. By considering the time to event (TTE) in addition to the tumor response endpoint, a mixed-endpoint phase II design may increase the efficiency and ability of selecting promising cytotoxic and cytostatic agents for further development. We proposed a single-arm phase II trial design by extending the Zee multinomial method to fully use mixed endpoints with tumor response and the TTE. In this design, the dependence between the probability of response and the TTE outcome is modeled through a Gaussian copula. Given the type I and type II errors and the hypothesis as defined by the response rate (RR) and median TTE, such as median TTP, the decision rules for a two-stage phase II trial design can be generated. We demonstrated through simulation that the proposed design has a smaller expected sample size and higher early stopping probability under the null hypothesis than designs based on a single-response endpoint or a single TTE endpoint. The proposed design is more efficient for screening new cytotoxic or cytostatic agents and less likely to miss an effective agent than the alternative single-arm design.

Outcome assessment of patients undergoing maxillofacial procedures for the treatment of sleep apnea: comparison of subjective and objective results.

PubMed

Dattilo, David J; Drooger, Scott A

2004-02-01

The purpose of this study was to compare the subjective findings of the Epworth Sleepiness Scale (ESS) to the objective findings of the overnight sleep study (OSS) in 57 patients who underwent phase I and phase II surgery for the correction of obstructive sleep apnea (OSA). Forty-two patients in phase I category (hyoid suspension, palatal surgery, and/or genioglossus advancement) and 15 patients in phase II category (maxillomandibular advancement) were examined. All patients had an OSS and completion of an ESS preoperatively and at a minimum of 8 weeks postoperatively. The results of each test were evaluated to examine any relationship between the improvements of the findings of the OSS to the changes in the ESS. Using accepted criteria, phase I surgery produced an 80% success rate and phase II surgery produced a greater than 95% success rate in both the respiratory disturbance index and the ESS. 1) Both phase I and phase II procedures are effective in treating OSA. 2) Phase II appears to be more effective in treating OSA using both objective and subjective evaluations. 3) Improvement in ESS scores and excessive daytime sleepiness seems to parallel the improvement in OSS scores in patients undergoing surgical correction of OSA.

The 11-item Medication Adherence Reasons Scale: reliability and factorial validity among patients with hypertension in Malaysian primary healthcare settings

PubMed Central

Shima, Razatul; Farizah, Hairi; Majid, Hazreen Abdul

2015-01-01

INTRODUCTION The aim of this study was to assess the reliability and validity of a modified Malaysian version of the Medication Adherence Reasons Scale (MAR-Scale). METHODS In this cross-sectional study, the 15-item MAR-Scale was administered to 665 patients with hypertension who attended one of the four government primary healthcare clinics in the Hulu Langat and Klang districts of Selangor, Malaysia, between early December 2012 and end-March 2013. The construct validity was examined in two phases. Phase I consisted of translation of the MAR-Scale from English to Malay, a content validity check by an expert panel, a face validity check via a small preliminary test among patients with hypertension, and exploratory factor analysis (EFA). Phase II involved internal consistency reliability calculations and confirmatory factor analysis (CFA). RESULTS EFA verified five existing factors that were previously identified (i.e. issues with medication management, multiple medications, belief in medication, medication availability, and the patient’s forgetfulness and convenience), while CFA extracted four factors (medication availability issues were not extracted). The final modified MAR-Scale model, which had 11 items and a four-factor structure, provided good evidence of convergent and discriminant validities. Cronbach’s alpha coefficient was > 0.7, indicating good internal consistency of the items in the construct. The results suggest that the modified MAR-Scale has good internal consistencies and construct validity. CONCLUSION The validated modified MAR-Scale (Malaysian version) was found to be suitable for use among patients with hypertension receiving treatment in primary healthcare settings. However, the comprehensive measurement of other factors that can also lead to non-adherence requires further exploration. PMID:25902719

The 11-item Medication Adherence Reasons Scale: reliability and factorial validity among patients with hypertension in Malaysian primary healthcare settings.

PubMed

Shima, Razatul; Farizah, Hairi; Majid, Hazreen Abdul

2015-08-01

The aim of this study was to assess the reliability and validity of a modified Malaysian version of the Medication Adherence Reasons Scale (MAR-Scale). In this cross-sectional study, the 15-item MAR-Scale was administered to 665 patients with hypertension who attended one of the four government primary healthcare clinics in the Hulu Langat and Klang districts of Selangor, Malaysia, between early December 2012 and end-March 2013. The construct validity was examined in two phases. Phase I consisted of translation of the MAR-Scale from English to Malay, a content validity check by an expert panel, a face validity check via a small preliminary test among patients with hypertension, and exploratory factor analysis (EFA). Phase II involved internal consistency reliability calculations and confirmatory factor analysis (CFA). EFA verified five existing factors that were previously identified (i.e. issues with medication management, multiple medications, belief in medication, medication availability, and the patient's forgetfulness and convenience), while CFA extracted four factors (medication availability issues were not extracted). The final modified MAR-Scale model, which had 11 items and a four-factor structure, provided good evidence of convergent and discriminant validities. Cronbach's alpha coefficient was > 0.7, indicating good internal consistency of the items in the construct. The results suggest that the modified MAR-Scale has good internal consistencies and construct validity. The validated modified MAR-Scale (Malaysian version) was found to be suitable for use among patients with hypertension receiving treatment in primary healthcare settings. However, the comprehensive measurement of other factors that can also lead to non-adherence requires further exploration.

A Fire Safety Certification System for Board and Care Operators and Staff. SBIR Phase II: Final Report.

ERIC Educational Resources Information Center

Walker, Bonnie L.

This report describes Phase II of a project which developed a system for delivering fire safety training to board and care providers who serve adults with developmental disabilities. Phase II focused on developing and pilot testing a "train the trainers" workshop for instructors and field testing the provider's workshop. Evaluation of…

Single-arm phase II trial design under parametric cure models.

PubMed

Wu, Jianrong

2015-01-01

The current practice of designing single-arm phase II survival trials is limited under the exponential model. Trial design under the exponential model may not be appropriate when a portion of patients are cured. There is no literature available for designing single-arm phase II trials under the parametric cure model. In this paper, a test statistic is proposed, and a sample size formula is derived for designing single-arm phase II trials under a class of parametric cure models. Extensive simulations showed that the proposed test and sample size formula perform very well under different scenarios. Copyright © 2015 John Wiley & Sons, Ltd.

Wellness-Promoting Practices Through Girl Scouts: A Pragmatic Superiority Randomized Controlled Trial With Additional Dissemination.

PubMed

Cull, Brooke J; Dzewaltowski, David A; Guagliano, Justin M; Rosenkranz, Sara K; Knutson, Cassandra K; Rosenkranz, Richard R

2018-01-01

To evaluate the effectiveness of in-person versus online Girl Scout leader wellness training for implementation of wellness-promoting practices during troop meetings (phase I) and to assess training adoption and current practices across the council (phase II). Pragmatic superiority trial (phase 1) followed by serial cross-sectional study (phase II). Girl Scout troop meetings in Northeast Kansas. Eighteen troop leaders from 3 counties (phase 1); 113 troop leaders from 7 counties (phase II). Phase I: Troop leaders attended 2 wellness training sessions (first in groups, second individually), wherein leaders set wellness-promoting practice implementation goals, self-monitored progress, and received guidance and resources for implementation. Leaders received the intervention in person or online. Phase I: At baseline and postintervention, leaders completed a wellness-promoting practice implementation questionnaire assessing practices during troop meetings (max score = 11). Phase II: Leaders completed a survey about typical troop practices and interest in further training. Phase I: Generalized linear mixed modeling. Phase I: In-person training increased wellness-promoting practice implementation more than online training (in person = 2.1 ± 1.8; online = 0.2 ± 1.2; P = .022). Phase II: Fifty-six percent of leaders adopted the training. For 8 of 11 wellness categories, greater than 50% of leaders employed wellness-promoting practices. In-person training was superior to online training for improvements in wellness-promoting practices. Wellness training was adopted by the majority of leaders across the council.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Starcher, Autumn N.; Elzinga, Evert J.; Sparks, Donald L.

Previous research demonstrated the formation of single divalent metal (Co, Ni, and ZnAl) and mixed divalent metal (NiZnAl) layered double hydroxide (LDH) phases from reactions of the divalent metal with Al-bearing substrates and soils in both laboratory experiments and in the natural environment. Recently Fe(II)-Al-LDH phases have been found in laboratory batch reaction studies, and although they have yet to be found in the natural environment. Potential locations of Fe(II)-Al-LDH phases in nature include areas with suboxic and anoxic conditions. Because these areas can be environments of significant contaminant accumulation, it is important to understand the possible interactions and impactsmore » of contaminant elements on LDH phase formation. One such contaminant, Zn, can also form as an LDH and has been found to form as a mixed divalent layered hydroxide phase. To understand how Zn impacts the formation of Fe(II)-Al-LDH phase formation and kinetics, 3 mM or 0.8 mM Fe(II) and 0.8 mM Zn were batch reacted with either 10 g/L pyrophyllite or 7.5 g/L γ-Al2O3 for up to three months under anoxic conditions. Aqueous samples were analyzed by inductively coupled plasma optical emission spectrometry (ICP-OES) and solid samples were analyzed with X-ray absorption spectroscopy (XAS). Shell-by-shell fits of Fe(II) and co-sorption samples with pyrophyllite show the formation of a mixed divalent metal (Fe(II)-Zn-Al) layered hydroxide phase, while Fe(II) and Zn co-sorption samples with γ-Al2O3 produce Fe(II)-Al-LDH phases and Zn in inner-sphere complexation with the γ-Al2O3. This study demonstrates the formation of a mixed divalent metal layered hydroxide and further iterates the importance of sorbent reactivity on LDH phase formation.« less

Evaluation of Usability Utilizing Markov Models

ERIC Educational Resources Information Center

Penedo, Janaina Rodrigues; Diniz, Morganna; Ferreira, Simone Bacellar Leal; Silveira, Denis S.; Capra, Eliane

2012-01-01

Purpose: The purpose of this paper is to analyze the usability of a remote learning system in its initial development phase, using a quantitative usability evaluation method through Markov models. Design/methodology/approach: The paper opted for an exploratory study. The data of interest of the research correspond to the possible accesses of users…

An Exploratory Study of a Gender Equity Program for Secondary School Students.

ERIC Educational Resources Information Center

Freeman, John G.

1996-01-01

The effectiveness of a program designed to make secondary school students in Canada more aware of barriers to women in the workplace was studied in a preliminary development phase and a pilot test with 13 students and 23 comparisons. Results indicate that the instruction is effective in increasing student knowledge. (SLD)

Asking to Listen: Towards a Youth Perspective on Sexual Health Education and Needs

ERIC Educational Resources Information Center

MacDonald, Jo-Ann; Gagnon, Anita J.; Mitchell, Claudia; Di Meglio, Giuseppina; Rennick, Janet E.; Cox, Joseph

2011-01-01

In this three-phase exploratory study, we used participatory approaches with youth in a small Canadian province. Through iterative focus groups in school settings, we examined young men and women's perspectives regarding factors important to taking control of their sexual health behaviour. Youth aged 15-17 discussed sexual health through…

Help Wanted: Exploring the Value of Entrepreneurial Mentoring at Start-Up

ERIC Educational Resources Information Center

Brodie, Jacqueline; Van Saane, Sebastiaan Huib; Osowska, Renata

2017-01-01

The purpose of the research presented in this article was to investigate the added value of mentoring for entrepreneurs during the start-up phase. This small-scale exploratory research focused on five start-up entrepreneurs in Scotland to determine the entrepreneurs' perceptions regarding the "added" value of their mentoring support. To…

Relationships between Telecommuting Workers and Their Managers: An Exploratory Study.

ERIC Educational Resources Information Center

Reinsch, N. Lamar, Jr.

1997-01-01

Finds that telecommuters, in interviews, consistently reported that telecommuting had been a success with few disadvantages, whereas questionnaire results suggest that the relationship between the telecommuter and his or her manager may deteriorate after an initial "honeymoon" phase has passed. Suggests that age and sex may affect a telecommuter's…

Auditory Processing Disorder and Auditory/Language Interventions: An Evidence-Based Systematic Review

ERIC Educational Resources Information Center

Fey, Marc E.; Richard, Gail J.; Geffner, Donna; Kamhi, Alan G.; Medwetsky, Larry; Paul, Diane; Ross-Swain, Deborah; Wallach, Geraldine P.; Frymark, Tobi; Schooling, Tracy

2011-01-01

Purpose: In this systematic review, the peer-reviewed literature on the efficacy of interventions for school-age children with auditory processing disorder (APD) is critically evaluated. Method: Searches of 28 electronic databases yielded 25 studies for analysis. These studies were categorized by research phase (e.g., exploratory, efficacy) and…

Understanding the Impacts of Quality Assessment: An Exploratory Use of Cultural Theory

ERIC Educational Resources Information Center

Veiga, Amelia; Rosa, Maria Joao; Amaral, Alberto

2011-01-01

Cultural theory is tentatively used to understand how far quality assessment affects institutions by influencing the group and grid dimensions. This paper argues that the self-assessment phase of the Portuguese system, in use until recently, promoted the egalitarian (logic of mistrusting power and expertise) and the individualist (logic of freedom…

Evaluators' Decision Making: The Relationship between Theory, Practice, and Experience

ERIC Educational Resources Information Center

Tourmen, Claire

2009-01-01

How do evaluation practitioners make choices when they evaluate a program? What function do evaluation theories play in practice? In this article, I report on an exploratory study that examined evaluation practices in France. The research began with observations of practitioners' activities, with a particular focus on the phases of evaluation…

Creative Endeavors: Inspiring Creativity in a First Grade Classroom

ERIC Educational Resources Information Center

Cress, Susan W.; Holm, Daniel T.

2016-01-01

With an emphasis on high-stakes testing and a focused curriculum, it would seem at times, the joy of creativity is missing from the classroom. This article describes a curricular approach the children named "Creative Endeavors", as implemented by a first grade teacher. The approach is described in three phases. In the exploratory stage…

Social Tagging in a Scholarly Digital Library Environment: Users' Perspectives

ERIC Educational Resources Information Center

Noorhidawati, A.; Hanum, N. Fariza; Zohoorian-Fooladi, N.

2013-01-01

Introduction: This paper reports an exploratory study examining how users participate in social tagging activities in a scholarly digital library environment to learn about their motivations, behaviour, and practices. Method: This study was conducted in two phases: a survey to investigate usage and attitudes of social tagging tool, and a…

An Emic, Mixed-Methods Approach to Defining and Measuring Positive Parenting among Low-Income Black Families

ERIC Educational Resources Information Center

McWayne, Christine M.; Mattis, Jacqueline S.; Green Wright, Linnie E.; Limlingan, Maria Cristina; Harris, Elise

2017-01-01

Research Findings: This within-group exploratory sequential mixed-methods investigation sought to identify how ethnically diverse, urban-residing, low-income Black families conceptualize positive parenting. During the item development phase 119 primary caregivers from Head Start programs participated in focus groups and interviews. These…

Anti-MRSA agents: under investigation, in the exploratory phase and clinically available.

PubMed

Bryskier, André

2005-08-01

Staphylococcal infections are difficult to treat due to the rapid emergence of methicillin-resistant staphylococci and, unfortunately, vancomycin-intermediate or -resistant staphylococci. Numerous alternative treatments are urgently required. In this special report, intensive research of new molecules is highlighted--in known antibacterial families and new medicinal chemical entities.

Exploratory modeling and simulation to support development of motesanib in Asian patients with non-small cell lung cancer based on MONET1 study results.

PubMed

Claret, L; Bruno, R; Lu, J-F; Sun, Y-N; Hsu, C-P

2014-04-01

The motesanib phase III MONET1 study failed to show improvement in overall survival (OS) in non-small cell lung cancer, but a subpopulation of Asian patients had a favorable outcome. We performed exploratory modeling and simulations based on MONET1 data to support further development of motesanib in Asian patients. A model-based estimate of time to tumor growth was the best of tested tumor size response metrics in a multivariate OS model (P < 0.00001) to capture treatment effect (hazard ratio, HR) in Asian patients. Significant independent prognostic factors for OS were baseline tumor size (P < 0.0001), smoking history (P < 0.0001), and ethnicity (P < 0.00001). The model successfully predicted OS distributions and HR in the full population and in Asian patients. Simulations indicated that a phase III study in 500 Asian patients would exceed 80% power to confirm superior efficacy of motesanib combination therapy (expected HR: 0.74), suggesting that motesanib combination therapy may benefit Asian patients.

Genome-wide expression profiling in pediatric septic shock

PubMed Central

Wong, Hector R.

2013-01-01

For nearly a decade, our research group has had the privilege of developing and mining a multi-center, microarray-based, genome-wide expression database of critically ill children (≤ 10 years of age) with septic shock. Using bioinformatic and systems biology approaches, the expression data generated through this discovery-oriented, exploratory approach have been leveraged for a variety of objectives, which will be reviewed. Fundamental observations include wide spread repression of gene programs corresponding to the adaptive immune system, and biologically significant differential patterns of gene expression across developmental age groups. The data have also identified gene expression-based subclasses of pediatric septic shock having clinically relevant phenotypic differences. The data have also been leveraged for the discovery of novel therapeutic targets, and for the discovery and development of novel stratification and diagnostic biomarkers. Almost a decade of genome-wide expression profiling in pediatric septic shock is now demonstrating tangible results. The studies have progressed from an initial discovery-oriented and exploratory phase, to a new phase where the data are being translated and applied to address several areas of clinical need. PMID:23329198

Electronic monitoring and voice prompts improve hand hygiene and decrease nosocomial infections in an intermediate care unit.

PubMed

Swoboda, Sandra M; Earsing, Karen; Strauss, Kevin; Lane, Stephen; Lipsett, Pamela A

2004-02-01

To determine whether electronic monitoring of hand hygiene and voice prompts can improve hand hygiene and decrease nosocomial infection rates in a surgical intermediate care unit. Three-phase quasi-experimental design. Phase I was electronic monitoring and direct observation; phase II was electronic monitoring and computerized voice prompts for failure to perform hand hygiene on room exit; and phase III was electronic monitoring only. Nine-room, 14-bed intermediate care unit in a university, tertiary-care institution. All patient rooms, utility room, and staff lavatory were monitored electronically. All healthcare personnel including physicians, nurses, nursing support personnel, ancillary staff, all visitors and family members, and any other personnel interacting with patients on the intermediate care unit. All patients with an intermediate care unit length of stay >48 hrs were followed for nosocomial infection. Electronic monitoring during all phases, computerized voice prompts during phase II only. We evaluated a total of 283,488 electronically monitored entries into a patient room with 251,526 exits for 420 days (10,080 hrs and 3,549 patient days). Compared with phase I, hand hygiene compliance in patient rooms improved 37% during phase II (odds ratio, 1.38; 95% confidence interval, 1.04-1.83) and 41% in phase III (odds ratio, 1.41; 95% confidence interval, 1.07-1.84). When adjusting for patient admissions during each phase, point estimates of nosocomial infections decreased by 22% during phase II and 48% during phase III; when adjusting for patient days, the number of infections decreased by 10% during phase II and 40% during phase III. Although the overall rate of nosocomial infections significantly decreased when combining phases II and III, the association between nosocomial infection and individual phase was not significant. Electronic monitoring provided effective ongoing feedback about hand hygiene compliance. During both the voice prompt phase and post-intervention phase, hand hygiene compliance and nosocomial infection rates improved suggesting that ongoing monitoring and feedback had both a short-term and, perhaps, a longer-term effect.

Grief and bereavement of Israeli dog owners: exploring short-term phases pre- and post-euthanization.

PubMed

Tzivian, Lilian; Friger, Michael; Kushnir, Talma

2014-01-01

Several studies have investigated the grief that owners experience after they euthanized their pets. However, research has not explored the cognitive and emotional processes those dog owners experience. The authors chose an exploratory approach and conducted a content analysis of 29 semistructured interviews of owners in the 2-week period after the death of their dogs. They found 5 main phases in the initial parting process: the decision to euthanize; anticipation and mental preparation; burial; mourning; and thinking about a new pet. All participants experienced these 5 common behavioral and emotional phases. There were only small individual differences among owners' reactions.

CMIF ECLS system test findings

NASA Technical Reports Server (NTRS)

Schunk, Richard G.; Carrasquillo, Robyn L.; Ogle, Kathyrn Y.; Wieland, Paul O.; Bagdigian, Robert M.

1989-01-01

During 1987 three Space Station integrated Environmental Control and Life Support System (ECLSS) tests were conducted at the Marshall Space Flight Center (MSFC) Core Module Integration Facility (CMIF) as part of the MSFC ECLSS Phase II test program. The three tests ranged in duration from 50 to 150 hours and were conducted inside of the CMIF module simulator. The Phase II partial integrated system test configuration consisted of four regenerative air revitalization subsystems and one regenerative water reclamation subsystem. This paper contains a discussion of results and lessons learned from the Phase II test program. The design of the Phase II test configuration and improvements made throughout the program are detailed. Future plans for the MSFC CMIF test program are provided, including an overview of planned improvements for the Phase III program.

Investing in Our Nation's Youth. National Youth Anti-Drug Media Campaign: Phase II (Final Report).

ERIC Educational Resources Information Center

Office of National Drug Control Policy, Washington, DC.

This publication presents the findings from an evaluation of Phase II of the National Youth Anti-Drug Media Campaign. The number one goal of the campaign was to educate youth to reject illegal drugs. This report evaluates Phase II and focuses on the effect of paid television advertising on awareness of anti-drug messages among youth, teens, and…

Labeled carbon dioxide (C18O2): an indicator gas for phase II in expirograms.

PubMed

Schulz, Holger; Schulz, Anne; Eder, Gunter; Heyder, Joachim

2004-11-01

Carbon dioxide labeled with 18O (C18O2) was used as a tracer gas for single-breath measurements in six anesthetized, mechanically ventilated beagle dogs. C18O2 is taken up quasi-instantaneously in the gas-exchanging region of the lungs but much less so in the conducting airways. Its use allows a clear separation of phase II in an expirogram even from diseased individuals and excludes the influence of alveolar concentration differences. Phase II of a C18O2 expirogram mathematically corresponds to the cumulative distribution of bronchial pathways to be traversed completely in the course of exhalation. The derivative of this cumulative distribution with respect to respired volume was submitted to a power moment analysis to characterize volumetric mean (position), standard deviation (broadness), and skewness (asymmetry) of phase II. Position is an estimate of dead space volume, whereas broadness and skewness are measures of the range and asymmetry of functional airway pathway lengths. The effects of changing ventilatory patterns and of changes in airway size (via carbachol-induced bronchoconstriction) were studied. Increasing inspiratory or expiratory flow rates or tidal volume had only minor influence on position and shape of phase II. With the introduction of a postinspiratory breath hold, phase II was continually shifted toward the airway opening (maximum 45% at 16 s) and became steeper by up to 16%, whereas skewness showed a biphasic response with a moderate decrease at short breath holding and a significant increase at longer breath holds. Stepwise bronchoconstriction decreased position up to 45 +/- 2% and broadness of phase II up to 43 +/- 4%, whereas skewness was increased up to twofold at high-carbachol concentrations. Under all circumstances, position of phase II by power moment analysis and dead space volume by the Fowler technique agreed closely in our healthy dogs. Overall, power moment analysis provides a more comprehensive view on phase II of single-breath expirograms than conventional dead space volume determinations and may be useful for respiratory physiology studies as well as for the study of diseased lungs.

Generation of phase II in vitro metabolites using homogenized horse liver.

PubMed

Wong, Jenny K Y; Chan, George H M; Leung, David K K; Tang, Francis P W; Wan, Terence S M

2016-02-01

The successful use of homogenized horse liver for the generation of phase I in vitro metabolites has been previously reported by the authors' laboratory. Prior to the use of homogenized liver, the authors' laboratory had been using mainly horse liver microsomes for carrying out equine in vitro metabolism studies. Homogenized horse liver has shown significant advantages over liver microsomes for in vitro metabolism studies as the procedures are much quicker and have higher capability for generating more in vitro metabolites. In this study, the use of homogenized liver has been extended to the generation of phase II in vitro metabolites (glucuronide and/or sulfate conjugates) using 17β-estradiol, morphine, and boldenone undecylenate as model substrates. It was observed that phase II metabolites could also be generated even without the addition of cofactors. To the authors' knowledge, this is the first report of the successful use of homogenized horse liver for the generation of phase II metabolites. It also demonstrates the ease with which both phase I and phase II metabolites can now be generated in vitro simply by using homogenized liver without the need for ultracentrifuges or tedious preparation steps. Copyright © 2015 John Wiley & Sons, Ltd.

A NEW LOOK AT THE EFFECTS OF ANXIETY AND STRESS ON THE PERFORMANCE OF COMPLEX INTELLECTUAL TASKS, STUDY II. SCHOOL ANXIETY AND COGNITIVE FUNCTIONING--EXPLORATORY STUDIES.

ERIC Educational Resources Information Center

DUNN, JAMES A.

THE EFFECTS OF TEST ANXIETY AND TEST STRESS ON THE PERFORMANCE OF TWO DIFFERENT INTELLECTUAL TASKS WERE STUDIED. IT WAS HYPOTHESIZED THAT THE DESCRIPTIVE EFFECTS OF ANXIETY WOULD BE GREATER FOR DIFFICULT BUT SIMPLE TASKS THAN FOR COMPLEX BUT EASY TASKS, AND THAT SITUATIONAL STRESS WOULD BE MORE DISRUPTIVE FOR COMPLEX TASKS THAN FOR SIMPLE TASKS. A…

Wavevector-Frequency Analysis with Applications to Acoustics

DTIC Science & Technology

1988-06-13

Investigator W . A. Strawderman (code 213). The funding for this work was provided by the NUSC In-House Independent Research and Exploratory Development...Wavevector-Frequency .. Response of a Damped, Infinite Plate .. ........... .... 3-53 3-11 Locus of the Maximum Magnitude of G(k, w ) for a Damped, Infinite...Simply Supported Plate .4.... ....... 4-18 d.... i ii . .’ . • IW"’,,’ .’,j,,,.,,.+,,,’- ’- w " % - % ’N, ". ". % .% .’ w V

Phenotypic variation of Pseudomonas brassicacearum as a plant root-colonization strategy.

PubMed

Achouak, Wafa; Conrod, Sandrine; Cohen, Valérie; Heulin, Thierry

2004-08-01

Pseudomonas brassicacearum was isolated as a major root-colonizing population from Arabidopsis thaliana. The strain NFM421 of P. brassicacearum undergoes phenotypic variation during A. thaliana and Brassica napus root colonization in vitro as well as in soil, resulting in different colony appearance on agar surfaces. Bacteria forming translucent colonies (phase II cells) essentially were localized at the surface of young roots and root tips, whereas wild-type cells (phase I cells) were localized at the basal part of roots. The ability of phase II cells to spread and colonize new sites on root surface correlates with over-production of flagellin as evidenced by sodium dodecyl sulfate-polyacrylamide gel electrophoresis analysis of surface proteins and microsequencing. Moreover, phase II cells showed a higher ability to swim and to swarm on semisolid agar medium. Phase I and phase II cells of P. brassicacearum NFM421 were tagged genetically with green fluorescent protein and red fluorescent protein. Confocal scanning laser microscopy was used to localize phase II cells on secondary roots and root tips of A. thaliana, whereas phase I cells essentially were localized at the basal part of roots. These experiments were conducted in vitro and in soil. Phenotypic variation on plant roots is likely to be a colonization strategy that may explain the high colonization power of P. brassicacearum.

Spiral chain structure of high pressure selenium-II{sup '} and sulfur-II from powder x-ray diffraction

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fujihisa, Hiroshi; Yamawaki, Hiroshi; Sakashita, Mami

2004-10-01

The structure of high pressure phases, selenium-II{sup '} (Se-II{sup '}) and sulfur-II (S-II), for {alpha}-Se{sub 8} (monoclinic Se-I) and {alpha}-S{sub 8} (orthorhombic S-I) was studied by powder x-ray diffraction experiments. Se-II{sup '} and S-II were found to be isostructural and to belong to the tetragonal space group I4{sub 1}/acd, which is made up of 16 atoms in the unit cell. The structure consisted of unique spiral chains with both 4{sub 1} and 4{sub 3} screws. The results confirmed that the structure sequence of the pressure-induced phase transitions for the group VIb elements depended on the initial molecular form. The chemicalmore » bonds of the phases are also discussed from the interatomic distances that were obtained.« less

Large Area Crop Inventory Experiment (LACIE). Phase 2 evaluation report

NASA Technical Reports Server (NTRS)

1977-01-01

Documentation of the activities of the Large Area Crop Inventory Experiment during the 1976 Northern Hemisphere crop year is presented. A brief overview of the experiment is included as well as phase two area, yield, and production estimates for the United States Great Plains, Canada, and the Union of Soviet Socialist Republics spring winter wheat regions. The accuracies of these estimates are compared with independent government estimates. Accuracy assessment of the United States Great Plains yardstick region based on a through blind sight analysis is given, and reasons for variations in estimating performance are discussed. Other phase two technical activities including operations, exploratory analysis, reporting, methods of assessment, phase three and advanced system design, technical issues, and developmental activities are also included.

The Origins of [C ii] Emission in Local Star-forming Galaxies

DOE Office of Scientific and Technical Information (OSTI.GOV)

Croxall, K. V.; Smith, J. D.; Pellegrini, E.

The [C ii] 158 μ m fine-structure line is the brightest emission line observed in local star-forming galaxies. As a major coolant of the gas-phase interstellar medium, [C ii] balances the heating, including that due to far-ultraviolet photons, which heat the gas via the photoelectric effect. However, the origin of [C ii] emission remains unclear because C{sup +} can be found in multiple phases of the interstellar medium. Here we measure the fractions of [C ii] emission originating in the ionized and neutral gas phases of a sample of nearby galaxies. We use the [N ii] 205 μ m fine-structuremore » line to trace the ionized medium, thereby eliminating the strong density dependence that exists in the ratio of [C ii]/[N ii] 122 μ m. Using the FIR [C ii] and [N ii] emission detected by the KINGFISH (Key Insights on Nearby Galaxies: a Far- Infrared Survey with Herschel ) and Beyond the Peak Herschel programs, we show that 60%–80% of [C ii] emission originates from neutral gas. We find that the fraction of [C ii] originating in the neutral medium has a weak dependence on dust temperature and the surface density of star formation, and has a stronger dependence on the gas-phase metallicity. In metal-rich environments, the relatively cooler ionized gas makes substantially larger contributions to total [C ii] emission than at low abundance, contrary to prior expectations. Approximate calibrations of this metallicity trend are provided.« less

Studies of Environmental Risk Factors in Amyotrophic Lateral Sclerosis (ALS) and a Phase I Clinical Trial of L-Serine.

PubMed

Bradley, Walter G; Miller, R X; Levine, T D; Stommel, E W; Cox, P A

2018-01-01

β-N-Methylamino-L-alanine (BMAA) has been linked to Guam ALS/PDC and shown to produce neurodegeneration in vitro and in vivo (Drosophila, mice, rats, primates). BMAA misincorporation into neuroproteins produces protein misfolding and is inhibited by L-serine. Case-control studies in Northern New England indicate that living near to water-bodies with cyanobacterial blooms increases the risk of developing amyotrophic lateral sclerosis (ALS). The distribution of addresses of ALS cases in New Hampshire, Vermont, and Florida was compared to that of controls. Areas of statistically significantly increased numbers of ALS cases were examined for sources of environmental toxins. A phase I trial of oral L-serine was performed in 20 ALS patients (0.5 to 15 g twice daily). Safety and tolerability were assessed by comparing the rate of deterioration with 430 matched placebo controls. The distribution of residential addresses of ALS cases in New England and Florida revealed many areas where the age- and gender-adjusted frequency of ALS was greater than expected (P < 0.01). GIS studies of these "hot spots" in relation to sources of environmental pollutants, like cyanobacterial blooms, Superfund and Brownfield sites, and landfills, are ongoing. In the phase I trial of L-serine, two patients withdrew from because of gastrointestinal side effects. Three patients died during the study, which was about the expected number. The ALSFRS-R in the L-serine-treated patients showed a dose-related decrease in the rate of progression (34% reduction in slope, P = 0.044). The non-random distribution of addresses of ALS patients suggests that residential exposure to environmental pollutants may play an important role in the etiology of ALS. L-Serine in doses up to 15 g twice daily appears to be safe in patients with ALS. Exploratory studies of efficacy suggested that L-serine might slow disease progression. A phase II trial is planned.

Beginning Teacher Evaluation Study: Phase II, 1973-74, Final Report: Volume III.2. Reading and Mathematics Observation System: Description and Analysis of Time Expenditures.

ERIC Educational Resources Information Center

Calfee, Robert; Calfee, Kathryn Hoover

The Beginning Teacher Evaluation Study (BTES), Phase II, was a research project on effective teaching behavior--what teachers do that significantly affects what and how pupils learn. The purposes of Phase II were to (1) develop an assessment system for measuring teacher and pupil behaviors and other factors which could influence each of them and…

Fractionation of Spatial Memory in GRM2/3 (mGlu2/mGlu3) Double Knockout Mice Reveals a Role for Group II Metabotropic Glutamate Receptors at the Interface Between Arousal and Cognition

PubMed Central

Lyon, Louisa; Burnet, Philip WJ; Kew, James NC; Corti, Corrado; Rawlins, J Nicholas P; Lane, Tracy; De Filippis, Bianca; Harrison, Paul J; Bannerman, David M

2011-01-01

Group II metabotropic glutamate receptors (mGluR2 and mGluR3, encoded by GRM2 and GRM3) are implicated in hippocampal function and cognition, and in the pathophysiology and treatment of schizophrenia and other psychiatric disorders. However, pharmacological and behavioral studies with group II mGluR agonists and antagonists have produced complex results. Here, we studied hippocampus-dependent memory in GRM2/3 double knockout (GRM2/3−/−) mice in an iterative sequence of experiments. We found that they were impaired on appetitively motivated spatial reference and working memory tasks, and on a spatial novelty preference task that relies on animals' exploratory drive, but were unimpaired on aversively motivated spatial memory paradigms. GRM2/3−/− mice also performed normally on an appetitively motivated, non-spatial, visual discrimination task. These results likely reflect an interaction between GRM2/3 genotype and the arousal-inducing properties of the experimental paradigm. The deficit seen on appetitive and exploratory spatial memory tasks may be absent in aversive tasks because the latter induce higher levels of arousal, which rescue spatial learning. Consistent with an altered arousal–cognition relationship in GRM2/3−/− mice, injection stress worsened appetitively motivated, spatial working memory in wild-types, but enhanced performance in GRM2/3−/− mice. GRM2/3−/− mice were also hypoactive in response to amphetamine. This fractionation of hippocampus-dependent memory depending on the appetitive-aversive context is to our knowledge unique, and suggests a role for group II mGluRs at the interface of arousal and cognition. These arousal-dependent effects may explain apparently conflicting data from previous studies, and have translational relevance for the involvement of these receptors in schizophrenia and other disorders. PMID:21832989

Model Transformation for a System of Systems Dependability Safety Case

NASA Technical Reports Server (NTRS)

Murphy, Judy; Driskell, Steve

2011-01-01

The presentation reviews the dependability and safety effort of NASA's Independent Verification and Validation Facility. Topics include: safety engineering process, applications to non-space environment, Phase I overview, process creation, sample SRM artifact, Phase I end result, Phase II model transformation, fault management, and applying Phase II to individual projects.

Early Restoration | NOAA Gulf Spill Restoration

Science.gov Websites

Early Restoration Plan. On April 20, 2011 we reached an agreement with BP to start restoration planning draft plan for the third phase of early restoration in December 2013. We are considering your comments : All Phase III information and documents Phase II Useful Links: Phase II Early Restoration Plan &

A framework to support human factors of automation in railway intelligent infrastructure.

PubMed

Dadashi, Nastaran; Wilson, John R; Golightly, David; Sharples, Sarah

2014-01-01

Technological and organisational advances have increased the potential for remote access and proactive monitoring of the infrastructure in various domains and sectors - water and sewage, oil and gas and transport. Intelligent Infrastructure (II) is an architecture that potentially enables the generation of timely and relevant information about the state of any type of infrastructure asset, providing a basis for reliable decision-making. This paper reports an exploratory study to understand the concepts and human factors associated with II in the railway, largely drawing from structured interviews with key industry decision-makers and attachment to pilot projects. Outputs from the study include a data-processing framework defining the key human factors at different levels of the data structure within a railway II system and a system-level representation. The framework and other study findings will form a basis for human factors contributions to systems design elements such as information interfaces and role specifications.

Effectiveness of safety belt warning and interlock systems

DOT National Transportation Integrated Search

1973-04-01

Rental cars in Fayetteville, N.C., were equipped with four seat belt and warning systems: (Phase I) detachable shoulder and lap belt, no warning system; (Phase II) detachable shoulder and lap belt, warning system (January 1, 1972 standard); (Phase II...

Recent Advances in Understanding of Kinetic Interplay Between Phase II Metabolism and Efflux Transport.

PubMed

Wang, Shuai; Xing, Huijie; Zhao, Mengjing; Lu, Danyi; Li, Zhijie; Dong, Dong; Wu, Baojian

2016-01-01

Mechanistic understanding of the metabolism-transport interplay assumes great importance in pharmaceutical fields because the knowledge can help to interpret drug/xenobiotic metabolism and disposition studies as well as the drug-drug interactions in vivo. About 10 years ago, it started to recognize that cellular phase II metabolism is strongly influenced by the excretion (efflux transport) of generated metabolites, a kinetic phenomenon termed "phase II metabolism-transport interplay". This interplay is believed to have significant effects on the pharmacokinetics (bioavailability) of drugs/chemicals undergoing phase II metabolism. In this article, we review the studies investigating the phase II metabolism-transport interplay using cell models, perfused rat intestine, and intact rats. The potential confounding factors in exploring such interplay is also summarized. Moreover, the mechanism underlying the phase II metabolism-transport interplay is discussed. Various studies with engineered cells and rodents have demonstrated that there is an interaction (interplay) between phase II enzymes and efflux transporters. This type of interplay mainly refers to the dependence of phase II (conjugative) metabolism on the activities of efflux transporters. In general, inhibiting efflux transporters or decreasing their expression causes the reductions in metabolite excretion, apparent excretion clearance (CLapp) and total metabolism (fmet), as well as an increase in the intracellular level of metabolite (Ci). The deconjugation mediated by hydrolase (acting as a "bridge") is essential for the interplay to play out based on pharmacokinetic modeling/simulations, cell and animal studies. The hydrolases bridge the two processes (i.e., metabolite formation and excretion) and enable the interplay thereof (a bridging effect). Without the bridge, metabolite formation is independent on its downstream process excretion, thus impact of metabolite excretion on its formation is impossible. Deconjugation (mediated by hydrolases) plays an essential role in the conjugation-transport interplay. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Phase-II trials in osteosarcoma recurrences: A systematic review of past experience.

PubMed

Omer, Natacha; Le Deley, Marie-Cécile; Piperno-Neumann, Sophie; Marec-Berard, Perrine; Italiano, Antoine; Corradini, Nadège; Bellera, Carine; Brugières, Laurence; Gaspar, Nathalie

2017-04-01

The most appropriate design of Phase-II trials evaluating new therapies in osteosarcoma remains poorly defined. To study consistency in phase-II clinical trials evaluating new therapies for osteosarcoma recurrences with respect to eligibility criteria, response assessment, end-points, statistical design and reported results. Systematic review of clinical trials registered on clinicaltrials.gov, clinicaltrialsregister.eu and French National Cancer Institute website or referenced in PubMed and American Society of Clinical Oncology websites, between 2003 and 2016, using the following criteria: (osteosarcoma OR bone sarcoma) AND (Phase-II). Among the 99 trials identified, 80 were Phase-II, 17 I/II and 2 II/III, evaluating mostly targeted therapy (n = 40), and chemotherapy alone (n = 26). Results were fully (n = 28) or partially (abstract, n = 6) published. Twenty-four trials were dedicated to osteosarcoma, 22 had an osteosarcoma stratum. Twenty-eight out of 99 trials refer to the age range observed at recurrence (28%). Overall, 65 trials were run in multicentre settings, including 17 international trials. Only 9 trials were randomised. The primary end-point was tumour response in 71 trials (response rate, n = 40 or best response, n = 31), with various definitions (complete + partial ± minor response and stable disease), mainly evaluated with RECIST criteria (n = 69); it was progression-free survival in 24 trials and OS in 3. In single-arm trials evaluating response rate, the null hypothesis tested (when available, n = 12) varied from 5% to 25%. No robust historical data can currently be derived from past efficacy Phase-II trials. There is an urgent need to develop international randomised Phase-II trials across all age ranges with standardised primary end-point. Copyright © 2017 Elsevier Ltd. All rights reserved.

Teaching mindfulness meditation to adults with severe speech and physical impairments: An exploratory study.

PubMed

Goodrich, Elena; Wahbeh, Helané; Mooney, Aimee; Miller, Meghan; Oken, Barry S

2015-01-01

People with severe speech and physical impairments may benefit from mindfulness meditation training because it has the potential to enhance their ability to cope with anxiety, depression and pain and improve their attentional capacity to use brain-computer interface systems. Seven adults with severe speech and physical impairments (SSPI) - defined as speech that is understood less than 25% of the time and/or severely reduced hand function for writing/typing - participated in this exploratory, uncontrolled intervention study. The objectives were to describe the development and implementation of a six-week mindfulness meditation intervention and to identify feasible outcome measures in this population. The weekly intervention was delivered by an instructor in the participant's home, and participants were encouraged to practise daily using audio recordings. The objective adherence to home practice was 10.2 minutes per day. Exploratory outcome measures were an n-back working memory task, the Attention Process Training-II Attention Questionnaire, the Pittsburgh Sleep Quality Index, the Perceived Stress Scale, the Positive and Negative Affect Schedule, and a qualitative feedback survey. There were no statistically significant pre-post results in this small sample, yet administration of the measures proved feasible, and qualitative reports were overall positive. Obstacles to teaching mindfulness meditation to persons with SSPI are reported, and solutions are proposed.

critcial human health issues in connection with future human missions to mMars: the HUMEX study of ESA

NASA Astrophysics Data System (ADS)

Horneck, G.; Humex Team

ESA has recently initiated a study of the human responses, limits and needs with regard to the stress environments of interplanetary and planetary missions. Emphasis was laid on human health and performance care as well as Advanced Life Support Developments including Bioregenerative Life Support Systems and environmental monitoring. The overall study goals were as follows: (i) to define reference scenarios for a European participation in human exploration and to estimate their influence on the Life Sciences and Life Support requirements; (ii) for selected mission scenarios, to critically assess the limiting factors for human health, wellbeing, and performance and to recommend relevant countermeasures; (iii) for selected mission scenarios, to critically assess the potential of Advanced Life Support Developments and to pro-pose a European strategy including terrestrial applications; (iv) to critically assess the feasibility of existing facilities and technologies on ground and in space as test-beds in preparation for human exploratory missions and to develop a test plan for ground and ISS campaigns; (v) to develop a roadmap for a future European strategy towards human exploratory missions, including preparatory activities and terrestrial applications and benefits. Two scenarios for a Mars mission were selected: (i) with a 30 days stay on Mars, and (ii) with about 500 days stay on Mars. The impact on human health, perform-ance and well being has been investigated from the view point of (i) the effects of microgravity (during space travel), reduced gravity (on Mars) and abrupt gravity changes (during launch and landing), (ii) the effects of cosmic radiation including solar particle events, (iii) psychological issues as well as general health care. Coun-termeasures as well as necessary research using ground-based testbeds and/or the ISS have been defined. The need for highly intelligent autonomous diagnostic and therapy systems was emphasized. Advanced life support systems with a high degree of autonomy and regenerative capacity and synergy effects were considered where bioregenerative life support systems and biodiagnostic systems become essential especially for the long-term Mars scenario. The considerations have been incorpo-rated into a roadmap for a future European strategy in human health issues for a potential European participation in a cooperative international exploration of our solar system by humans. Ref. Horneck et al, 2003, HUMEX, study on the Survivability and Adaptation of Humans to Long-Duration Exploratory Missions, ESA SP 1264

Reflective Cracking of Flexible Pavements Phase I and II Final Recommendations

DOT National Transportation Integrated Search

2008-02-02

This report summarizes all the findings and recommendations from the Phase I and Phase II of the Nevada Department of Transportation (NDOT) study initiated in 2006 to mitigate reflective cracking in hot mix asphalt (HMA) overlays. Based on the analys...

Evaluation Framework Based on Fuzzy Measured Method in Adaptive Learning Systems

ERIC Educational Resources Information Center

Ounaies, Houda Zouari; Jamoussi, Yassine; Ben Ghezala, Henda Hajjami

2008-01-01

Currently, e-learning systems are mainly web-based applications and tackle a wide range of users all over the world. Fitting learners' needs is considered as a key issue to guaranty the success of these systems. Many researches work on providing adaptive systems. Nevertheless, evaluation of the adaptivity is still in an exploratory phase.…

Students' Approaches to the Evaluation of Digital Information: Insights from Their Trust Judgments

ERIC Educational Resources Information Center

Johnson, Frances; Sbaffi, Laura; Rowley, Jennifer

2016-01-01

This study contributes to an understanding of the role of experience in the evaluation phase of the information search process. A questionnaire-based survey collected data from 1st and 3rd-year undergraduate students regarding the factors that influence their judgment of the trustworthiness of online health information. Exploratory and…

The Application of a Resilience Assessment Approach to Promote Campus Environmental Management: A South African Case Study

ERIC Educational Resources Information Center

Muller, Irene; Tempelhoff, Johann

2016-01-01

Purpose: This paper aims to outline the benefits of using resilience assessment instead of command and control mechanisms to evaluate sustainable campus environments. Design/Methodology/Approach: An exploratory mixed-method design was followed for the purposes of the project. During the first qualitative phase, a historical timeline of the focal…

US NDC Modernization Iteration E1 Prototyping Report: User Interface Framework

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lober, Randall R.

2014-12-01

During the first iteration of the US NDC Modernization Elaboration phase (E1), the SNL US NDC modernization project team completed an initial survey of applicable COTS solutions, and established exploratory prototyping related to the User Interface Framework (UIF) in support of system architecture definition. This report summarizes these activities and discusses planned follow-on work.

US NDC Modernization Iteration E1 Prototyping Report: Common Object Interface

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lewis, Jennifer E.; Hess, Michael M.

2014-12-01

During the first iteration of the US NDC Modernization Elaboration phase (E1), the SNL US NDC modernization project team completed an initial survey of applicable COTS solutions, and established exploratory prototyping related to the Common Object Interface (COI) in support of system architecture definition. This report summarizes these activities and discusses planned follow-on work.

US NDC Modernization Iteration E1 Prototyping Report: Processing Control Framework

DOE Office of Scientific and Technical Information (OSTI.GOV)

Prescott, Ryan; Hamlet, Benjamin R.

2014-12-01

During the first iteration of the US NDC Modernization Elaboration phase (E1), the SNL US NDC modernization project team developed an initial survey of applicable COTS solutions, and established exploratory prototyping related to the processing control framework in support of system architecture definition. This report summarizes these activities and discusses planned follow-on work.

NHEXAS PHASE I MARYLAND STUDY--STANDARD OPERATING PROCEDURE FOR EXPLORATORY DATA ANALYSIS AND SUMMARY STATISTICS (D05)

EPA Science Inventory

This SOP describes the methods and procedures for two types of QA procedures: spot checks of hand entered data, and QA procedures for co-located and split samples. The spot checks were used to determine whether the error rate goal for the input of hand entered data was being att...

Exploring Links between Empowerment and Community-Based Arts and Cultural Practices: Perspectives from Barcelona Practitioners

ERIC Educational Resources Information Center

Carrasco, Ruben David Fernández; Monferrer, Moisés Carmona; Tarditi, Andrés Di Masso

2016-01-01

In this paper, we reflect on the development of community-based arts and cultural (CBAC) practices to promote psychosocial, group/organisational and community changes from the perspective of empowerment. We draw on findings from an initial exploratory phase of an ongoing action-research project in Spain about creative tools that empower artists…

Focus on Process Skills. Learning in Science Project. Working Paper No. 7.

ERIC Educational Resources Information Center

Tasker, Ross; And Others

The first (exploratory) phase of the Learning in Science Project focused on science teaching/learning in the Form 1 to 4 level (ages 10 to 14) and sought to identify problems and difficulties in several areas. Provided in this paper are comments obtained during structured/unstructured interviews (from students, ex-students, teachers, headmasters,…

Focus on Attitudes. Learning in Science Project. Working Paper No. 9.

ERIC Educational Resources Information Center

Stead, Keith; And Others

The first (exploratory) phase of the Learning in Science Project focused on science teaching/learning in the Form 1 to 4 level (ages 10 to 14) and sought to identify problems and difficulties in several areas. Provided in this paper are comments obtained during structured/unstructured interviews (from students, ex-students, teachers, headmasters,…

Research in Progress--Update April 1990. Occasional Paper InTER/14/90.

ERIC Educational Resources Information Center

Boots, Maureen, Comp.

This document contains abstracts of 29 research projects in progress in Great Britain divided into six sections: (1) the current phase of Information Technology in Education Research (InTER) programs on groupwork with computers, tools for exploratory learning, conceptual change in science, and bubble dialogue as an ethnographic research tool; (2)…

Course of Study: Occupational, Vocational, and Technical Education: Phase 3--8th Grade. Exploratory Education.

ERIC Educational Resources Information Center

Pittsburgh Board of Public Education, PA.

The curriculum guide outlines learning patterns which may be adapted or adopted by the creative teacher in occupational education. Emphasis is placed on processes basic to specific job activities found within the areas of: (1) business education, (2) home economics, and (3) industrial arts. Students are able to associate, integrate, and catalog…

Reconsidering the Framework. Learning in Science Project. Working Paper No. 14.

ERIC Educational Resources Information Center

Osborne, Roger; And Others

The first working paper of the Learning in Science Project, "An Initial Framework," outlined what was then seen as the major aims of the project and suggested how these aims might be achieved by three phases of research: exploratory (to observe teaching/learning in Form 1 to 4 science classrooms and to identify difficulties perceived by…

Perceptions of Kentucky High School Principals and Superintendents on the Role of the Superintendent Influencing Principal Instructional Leadership

ERIC Educational Resources Information Center

Hamilton, Charles L., Jr.

2011-01-01

This exploratory study surveyed the promotion of instructional leadership of high school principals by superintendents, as perceived by self and the principals they supervise. The two-phased study included an initial questionnaire administered to both study groups and comparisons of responses analyzed. All superintendents (N = 173), except the…

Prostate Cancer Clinical Trials Group: The University of Michigan Site

DTIC Science & Technology

2012-04-01

and fusion-negative strata. UM will be the lead site for this trial with the Univ. of Chicago N01 Phase II consortium as the coordinating center. Ten...sensitive prostate cancer: a University of Chicago Phase II Consortium/Department of Defense Prostate Cancer Clinical Trials Consortium study. JE Ward, T...N01 contract with CTEP (University of Chicago – Early Therapeutics Development with Phase II emphasis group). The Program is committed to creating

The effect of high-, moderate-, and low-fat diets on weight loss and cardiovascular disease risk factors.

PubMed

Fleming, Richard M

2002-01-01

Over 60% of Americans are overweight and a number of popular diets have been advocated, often without evidence, to alleviate this public health hazard. This study was designed to investigate the effects of several diets on weight loss, serum lipids, and other cardiovascular disease risk factors. One hundred men and women followed one of four dietary programs for 1 year: a moderate-fat (MF) program without calorie restriction (28 patients); a low-fat (LF) diet (phase I) (16) ; a MF, calorie-controlled (phase II) diet (38 patients); and a high-fat (HF) diet (18 subjects) [corrected]. Weight, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), homocysteine (Ho), and lipoprotein(a) [Lp(a)], were measured every 4th month. The TC/HDL-C ratio was calculated and fibrinogen levels were measured at baseline and after one year. The MF diet resulted in a 2.6% (NS) decrease in weight compared with 18.4% (p=0.045) decrease in patients on phase I, 12.6% (p=0.0085) decrease in patients on phase II, and 13.7% (p=0.025) decrease in those on the HF diet. TC was reduced by 5% (NS) in the MF group, 39.1% (p=0.0005) in the phase I group, and 30.4% (p=0.0001) in the phase II group. HF group had a 4.3% (NS) increase in TC. LDL-C was reduced by 6.1% (NS) on MF, 52.0% (p=0.0001) on phase I, and 38.8% (p=0.0001) on phase II. Patients on HF had a 6.0% (NS) increase in LDL-C. There were nonsignificant reductions in HDL-C in those on MF (-1.5%) and HF (-5.8%). Patients on phase I showed an increase in HDL-C of 9.0% (NS), while those on phase II diet had a 3.6% increase (NS) in HDL-C. TC/HDL-C increased (9.8%) only in patients following the high-fat diets (NS). Patients on MF had a 5.3% (NS) reduction in TC/HDL-C, while those on LF had significant reductions on the phase I ( -45.8%; p=0.0001) diet and phase II diet (-34.7%; p=0.0001). TG levels increased on both the MF (1.0%) and HF (5.5%) diets, although neither was statistically significant. People following the phase I and II diets showed reductions of 37.3% and 36.9%, respectively. Ho levels increased by 9.7% when people followed the MF diet and by 12.4% when they followed the HF diet. Patients following the phase I and phase II diets showed reductions of 13.6% and 14.6%, respectively. Only those following phase II diets showed a tendency toward significant improvement (p=0.061). Lp(a) levels increased by 4.7% following the MF (NS) diet and by 31.0% (NS) on the HF diet. Patients following phase I showed a 7.4% (NS) reduction and a 10.8% reduction (NS) following phase II. Fibrinogen levels increased only in individuals following HF diets (11.9%), while patients following MF (-0.6%), phase I (-11.0%), and phase II (-6.3%) diets showed nonsignificant reductions in fibrinogen. Patients on MF demonstrated nonsignificant reductions in weight, LDL-C, TC, HDL-C, TC/HDL-C ratios, and fibrinogen and nonsignificant increases in TGs, Lp(a), and homocysteine. There was significant weight loss in patients on phase I and II and HF diets after 1 year. Reductions in TC, LDL-C, TGs, and TC/HDL ratios were significant only in patients either following a LF diet or a MF, calorically reduced diet. Only patients following HF diets showed a worsening of each cardiovascular disease risk factor (LDL-C, TG, TC, HDL-C, TC/HDL ratio, Ho, Lp(a), and fibrinogen), despite achieving statistically significant weight loss. Copyright 2002 CHF, Inc.

Research safety vehicle, Phase II. Volume I. Executive summary. Final report jul 75-dec 76

DOE Office of Scientific and Technical Information (OSTI.GOV)

Struble, D.

1976-12-01

Volume I summarizes the results of the Minicars Research Safety Vehicle Phase II program, as detailed in Volumes II and III. Phase I identified trends leading to the desired national social goals of the mid-1980's in vehicle crashworthiness, crash avoidance, damageability, pedestrian safety, fuel economy, emissions and cost, and characterized an RSV to satisfy them. In Phase II an RSV prototype was designed, developed and tested to demonstrate the feasibility of meeting these goals simultaneously. Although further refinement is necessary to assure operational validity, in all categories the results meet or exceed the most advanced performance specified by The Presidentialmore » Task Force on Motor Vehicle Goals beyond 1980.« less

The use of dihexyldithiocarbamate in reverse-phase HPLC of metal chelates

NASA Astrophysics Data System (ADS)

Fatimah, S. S.; Bahti, H. H.; Hastiawan, I.; Permanasari, A.

2018-05-01

Dialkyldithiocarbamates have long been used as chelating agents in reverse-phase HPLC of transition metals. In the previous study, an alkyl homolog of this type of ligand, namely dihexyldithiocarbamate (DHDTC), was synthesized and characterized. The use of this particular ligand in the revese-phase HPLC of some selected transition metal ions is now reported for the first time. The mobile phase comprising of the flow rate and of the detection, in the separation of the metal chelates of Cd (II), Fe (III), Cu (II), and Co (III), were investigated on a C-18 column. The results showed that dihexylditiocarbamate could be used for separating Cd (II), Fe(III), Cu(II), and Co(III). Therefore, it could be used in simultaneous analysis.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nichols, Ralph L.; Seitz, Roger R.; Dixon, Kenneth L.

The Waste Treatment and Immobilization Plant (WTP) at Hanford is being constructed to treat 56 million gallons of radioactive waste currently stored in underground tanks at the Hanford site. Operation of the WTP will generate several solid secondary waste (SSW) streams including used process equipment, contaminated tools and instruments, decontamination wastes, high-efficiency particulate air filters (HEPA), carbon adsorption beds, silver mordenite iodine sorbent beds, and spent ion exchange resins (IXr) all of which are to be disposed in the Integrated Disposal Facility (IDF). An applied research and development program was developed using a phased approach to incrementally develop the informationmore » necessary to support the IDF PA with each phase of the testing building on results from the previous set of tests and considering new information from the IDF PA calculations. This report contains the results from the exploratory phase, Phase 1 and preliminary results from Phase 2. Phase 3 is expected to begin in the fourth quarter of FY17.« less

Impact Assessment and Forecasts of Information and Telecommunications Technologies Applied to Education and Training: Volume II--Main Report and Issues Analyses. Analysis for the Orientation of the Work of Sector Actors in the Framework of DELTA.

ERIC Educational Resources Information Center

Commission of the European Communities, Brussels (Belgium).

This report, the second volume in a three volume set, summarizes the results of a study performed by the DELTA (Developing European Learning through Technological Advance) unit in parallel with the projects underway in the research and development Exploratory Action. The report identifies the key issues, associated requirements and options, and…

A two-stage patient enrichment adaptive design in phase II oncology trials.

PubMed

Song, James X

2014-01-01

Illustrated is the use of a patient enrichment adaptive design in a randomized phase II trial which allows the evaluation of treatment benefits by the biomarker expression level and makes interim adjustment according to the pre-specified rules. The design was applied to an actual phase II metastatic hepatocellular carcinoma (HCC) trial in which progression-free survival (PFS) in two biomarker-defined populations is evaluated at both interim and final analyses. As an extension, a short-term biomarker is used to predict the long-term PFS in a Bayesian model in order to improve the precision of hazard ratio (HR) estimate at the interim analysis. The characteristics of the extended design are examined in a number of scenarios via simulations. The recommended adaptive design is shown to be useful in a phase II setting. When a short-term maker which correlates with the long-term PFS is available, the design can be applied in smaller early phase trials in which PFS requires longer follow-up. In summary, the adaptive design offers flexibility in randomized phase II patient enrichment trials and should be considered in an overall personalized healthcare (PHC) strategy. Copyright © 2013 Elsevier Inc. All rights reserved.

U10 : Trusted Truck(R) II (phase B).

DOT National Transportation Integrated Search

2009-01-01

Phase B of the Trusted Truck II project built on the system developed in Phase A (or Year 1). For the implementation portion of the project, systems were added to the trailer to provide additional diagnostic trailer data that can be sent to the TTM...

Movement Analysis Applied to the Basketball Jump Shot--Part II.

ERIC Educational Resources Information Center

Martin, Thomas P.

1981-01-01

The jump shot is one of the most important shots in the game of basketball. The movement analysis of the jump shot designates four phases: (1) preparatory position; (2) movement phase I (crouch); (3) movement phase II (jump); and (4) follow-through. (JN)

A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of Dignity Therapy for older people in care homes: Study protocol

PubMed Central

Hall, Sue; Chochinov, Harvey; Harding, Richard; Murray, Scott; Richardson, Alison; Higginson, Irene J

2009-01-01

Background Although most older people living in nursing homes die there, there is a dearth of robust evaluations of interventions to improve their end-of-life care. Residents usually have multiple health problems making them heavily reliant on staff for their care, which can erode their sense of dignity. Dignity Therapy has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting has suggested that Dignity Therapy is beneficial to people dying of cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people reaching the end of life in care homes, and to pilot the methods for a Phase III RCT. Methods/design A randomised controlled open-label trial. Sixty-four residents of care homes for older people are randomly allocated to one of two groups: (i) Intervention (Dignity Therapy offered in addition to any standard care), and (ii) Control group (standard care). Recipients of the "generativity" documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and eight weeks after the intervention (equivalent in the control group). The primary outcome is residents' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory. Secondary outcomes for residents include depression, hopefulness and quality of life. In view of the relatively small sample size, quantitative analysis is mainly descriptive. The qualitative analysis uses the Framework method. Discussion Dignity Therapy is brief, can be done at the bedside and could help both patients and their families. This detailed exploratory research shows if it is feasible to offer Dignity Therapy to residents of care homes, whether it is acceptable to them, their families and care home staff, if it is likely to be effective, and determine whether a Phase III RCT is desirable. Trial registration Current Controlled Clinical Trials: ISRCTN37589515 PMID:19317898

Quantitation of anacetrapib, stable-isotope labeled-anacetrapib (microdose), and four metabolites in human plasma using liquid chromatography tandem mass spectrometry.

PubMed

Chavez-Eng, C M; Lutz, R W; Li, H; Goykhman, D; Bateman, K P; Woolf, E

2016-02-01

An ultra-high performance liquid chromatography/tandem mass spectrometry (UPLC-MS/MS) method for the simultaneous determination of (4S,5R)-5-[3,5-bis (trifluoromethyl)phenyl]-3-{[4'-fluoro-5'-isopropyl-2'-methoxy-4-(trifluoromethyl)biphenyl-2-yl] methyl}-4-methyl-1,3-oxazolidin-2-one (anacetrapib, I) and [(13)C5(15)N]-anacetrapib, II in human plasma has been developed to support a clinical study to determine the absolute bioavailability of I. The analytes and the stable-isotope labeled internal standard ([(13)C7(15)N(2)H7]-anacetrapib, III) were extracted from 100μL of human plasma by liquid-liquid extraction using 20/80 isopropyl alcohol/hexane (v/v). The chromatographic separation of the analytes was achieved using Waters BEH Shield RP 18 (50×2.1mm×1.7μm) column and mobile phase gradient of 0.1% formic acid in water (Solvent A) and 0.1% formic acid in acetonitrile (Solvent B) at 0.6mL/min flow rate. The MS/MS detection was performed on AB Sciex 5000 or AB 5500 in positive electrospray ionization mode, operated in selected reaction monitoring mode. The assay was validated in the concentration range 1-2000ng/mL for I; and a lower curve range, 0.025-50ng/mL for II. In addition to the absolute bioavailability determination, it was desired to better elucidate the pharmacokinetic behavior of several hydroxylated metabolites of I. Toward this end, two exploratory assays for the hydroxy metabolites of I were qualified in the concentration range 0.5-500ng/mL. All metabolites were separated on a Supelco Ascentis Express Phenyl-Hexyl (50×2.1mm, 2.7μm) column. Metabolite M4 was analyzed in the negative mode with a mobile phase consisting of a gradient mixture of water (A) and acetonitrile (B). The other three metabolites, M1-M3 were analyzed in the positive mode using a mobile phase gradient of water with 0.1% formic acid (A) and acetonitrile with 0.1% formic acid (B). The assays were utilized to support a clinical study in which a microdosing approach was used to determine the pharmacokinetics of anacetrapib and its metabolites. Copyright © 2016 Elsevier B.V. All rights reserved.

A Web-Based Intervention to Reduce Distress After Prostate Cancer Treatment: Development and Feasibility of the Getting Down to Coping Program in Two Different Clinical Settings.

PubMed

Cockle-Hearne, Jane; Barnett, Deborah; Hicks, James; Simpson, Mhairi; White, Isabel; Faithfull, Sara

2018-04-30

Distress after prostate cancer treatment is a substantial burden for up to one-third of men diagnosed. Physical and emotional symptoms and health service use can intensify, yet men are reticent to accept support. To provide accessible support that can be cost effectively integrated into care pathways, we developed a unique, Web-based, self-guided, cognitive-behavior program incorporating filmed and interactive peer support. To assess feasibility of the intervention among men experiencing distress after prostate cancer treatment. Demand, acceptability, change in distress and self-efficacy, and challenges for implementation in clinical practice were measured. A pre-post, within-participant comparison, mixed-methods research design was followed. Phase I and II were conducted in primary care psychological service and secondary care cancer service, respectively. Men received clinician-generated postal invitations: phase I, 432 men diagnosed <5 years; phase II, 606 men diagnosed <3.5 years. Consent was Web-based. Men with mild and moderate distress were enrolled. Web-based assessment included demographic, disease, treatment characteristics; distress (General Health Questionnaire-28); depression (Patient Health Questionnaire-9); anxiety (General Anxiety Disorder Scale-7); self-efficacy (Self-Efficacy for Symptom Control Inventory); satisfaction (author-generated, Likert-type questionnaire). Uptake and adherence were assessed with reference to the persuasive systems design model. Telephone interviews explored participant experience (phase II, n=10); interviews with health care professionals (n=3) explored implementation issues. A total of 135 men consented (phase I, 61/432, 14.1%; phase II, 74/606, 12.2%); from 96 eligible men screened for distress, 32% (30/96) entered the intervention (phase I, n=10; phase II, n=20). Twenty-four completed the Web-based program and assessments (phase I, n=8; phase II, n=16). Adherence for phase I and II was module completion rate 63% (mean 2.5, SD 1.9) versus 92% (mean 3.7, SD 1.0); rate of completing cognitive behavior therapy exercises 77% (mean 16.1, SD 6.2) versus 88% (mean 18.6, SD 3.9). Chat room activity occurred among 63% (5/8) and 75% (12/16) of men, respectively. In phase I, 75% (6/8) of men viewed all the films; in phase II, the total number of unique views weekly was 16, 11, 11, and 10, respectively. The phase II mood diary was completed by 100% (16/16) of men. Satisfaction was high for the program and films. Limited efficacy testing indicated improvement in distress baseline to post intervention: phase I, P=.03, r=-.55; phase II, P=.001, r=-.59. Self-efficacy improved for coping P=.02, r=-.41. Service assessment confirmed ease of assimilation into clinical practice and clarified health care practitioner roles. The Web-based program is acceptable and innovative in clinical practice. It was endorsed by patients and has potential to positively impact the experience of men with distress after prostate cancer treatment. It can potentially be delivered in a stepped model of psychological support in primary or secondary care. Feasibility evidence is compelling, supporting further evaluative research to determine clinical and cost effectiveness. ©Jane Cockle-Hearne, Deborah Barnett, James Hicks, Mhairi Simpson, Isabel White, Sara Faithfull. Originally published in JMIR Cancer (http://cancer.jmir.org), 30.04.2018.

A Web-Based Intervention to Reduce Distress After Prostate Cancer Treatment: Development and Feasibility of the Getting Down to Coping Program in Two Different Clinical Settings

PubMed Central

Barnett, Deborah; Hicks, James; Simpson, Mhairi; White, Isabel; Faithfull, Sara

2018-01-01

Background Distress after prostate cancer treatment is a substantial burden for up to one-third of men diagnosed. Physical and emotional symptoms and health service use can intensify, yet men are reticent to accept support. To provide accessible support that can be cost effectively integrated into care pathways, we developed a unique, Web-based, self-guided, cognitive-behavior program incorporating filmed and interactive peer support. Objective To assess feasibility of the intervention among men experiencing distress after prostate cancer treatment. Demand, acceptability, change in distress and self-efficacy, and challenges for implementation in clinical practice were measured. Methods A pre-post, within-participant comparison, mixed-methods research design was followed. Phase I and II were conducted in primary care psychological service and secondary care cancer service, respectively. Men received clinician-generated postal invitations: phase I, 432 men diagnosed <5 years; phase II, 606 men diagnosed <3.5 years. Consent was Web-based. Men with mild and moderate distress were enrolled. Web-based assessment included demographic, disease, treatment characteristics; distress (General Health Questionnaire-28); depression (Patient Health Questionnaire-9); anxiety (General Anxiety Disorder Scale-7); self-efficacy (Self-Efficacy for Symptom Control Inventory); satisfaction (author-generated, Likert-type questionnaire). Uptake and adherence were assessed with reference to the persuasive systems design model. Telephone interviews explored participant experience (phase II, n=10); interviews with health care professionals (n=3) explored implementation issues. Results A total of 135 men consented (phase I, 61/432, 14.1%; phase II, 74/606, 12.2%); from 96 eligible men screened for distress, 32% (30/96) entered the intervention (phase I, n=10; phase II, n=20). Twenty-four completed the Web-based program and assessments (phase I, n=8; phase II, n=16). Adherence for phase I and II was module completion rate 63% (mean 2.5, SD 1.9) versus 92% (mean 3.7, SD 1.0); rate of completing cognitive behavior therapy exercises 77% (mean 16.1, SD 6.2) versus 88% (mean 18.6, SD 3.9). Chat room activity occurred among 63% (5/8) and 75% (12/16) of men, respectively. In phase I, 75% (6/8) of men viewed all the films; in phase II, the total number of unique views weekly was 16, 11, 11, and 10, respectively. The phase II mood diary was completed by 100% (16/16) of men. Satisfaction was high for the program and films. Limited efficacy testing indicated improvement in distress baseline to post intervention: phase I, P=.03, r=−.55; phase II, P=.001, r=−.59. Self-efficacy improved for coping P=.02, r=−.41. Service assessment confirmed ease of assimilation into clinical practice and clarified health care practitioner roles. Conclusions The Web-based program is acceptable and innovative in clinical practice. It was endorsed by patients and has potential to positively impact the experience of men with distress after prostate cancer treatment. It can potentially be delivered in a stepped model of psychological support in primary or secondary care. Feasibility evidence is compelling, supporting further evaluative research to determine clinical and cost effectiveness. PMID:29712628

Deep Bore Storage of Nuclear Waste Using MMW (Millimeter Wave) Technology, STTR Fast Track Project, Phase I Final Report-Revised

DOE Office of Scientific and Technical Information (OSTI.GOV)

Oglesby, Kenneth D.; Woskov, Paul; Einstein, Herbert

This report covers the technical work in Phase I of this DOE-Nuclear Program STTR Fast Track project. All key tasks were successfully performed, new tasks were added to utilize DOD-AFRL’s 95 GigaHertz (GHz) gyrotron in Phase II, while other lesser tasks were left for Phase II efforts or were requested to be made optional. This research adds to our understanding of using MMW power to melt and vaporize rocks and steel/ metals and laid plans for future testing in Phase II. This work built upon a prior DOE project DE-EE0005504 that developed the basic waveguide setup, process and instruments. Inmore » this project we were investigating the use of MMW to form rock melt and steel plugs in deep wells to further isolate highly radioactive nuclear waste in ultra-deep basement rocks for long term storage. This technology also has potential for deep well drilling for nuclear storage, geothermal and oil and gas industries. It also has the potential for simultaneously sealing and securing the wellbore with a thick rock melt liner as the wellbore is drilled. This allows for higher levels of safety and protection of the environment during deep drilling operations. The larger purpose of this project was to find answers to key questions in progressing MMW technology for these applications. Phase I of this project continued bench testing using the MIT 10 kilo-Watt (kW), 28 GHz frequency laboratory gyrotron, literature searches, planning and design of equipment for Phase II efforts. Furnace melting and rock testing (Tasks 4 and 5) were deferred to Phase II due to lack of concurrent availability of the furnace and personnel at MIT. That delay and lower temperature furnace (limited to 1650oC) caused rethinking of Task 4 to utilize coordinated rock selection with the DOD testing in Phase II. The high pressure and high power window design work (moved to Phase I Task 3 from Phase II Task 20) and Additive materials and methods (Tasks 7 & 8) performed in Phase I may become patentable and thus little detail can be provided in this public report. A version of that new high pressure, high MMW power window may be built for possible Phase II testing at the DOD site. Most significantly, additional tasks were added for planning the use of the Department of Defense, Air Force Research Laboratory’s (DOD-AFRL’s) System 0 gyrotron in Phase II. Specifically added and accomplished were multiple discussions on DOD and DOE-MIT-Impact goals, timing between ongoing DOD testing, outlining the required equipment and instruments for rock testing, and terms for an agreement. That addition required a visit to Kirtland AFB in Albuquerque, New Mexico to talk to key DOD-AFRL personnel and management. A DOD-Impact-MIT charter (i.e., contract) is now being circulated for signatures. Also added task to Phase I, MIT designed the critical path reflected power isolator screen for Phase II testing. To ensure compatibility, that design was computer simulated for the expected heat load distribution and the resulting temperature increase. Advancing the MMW testing up to the optimum 95 GHz and 100kW (5X higher) power levels was stated in the original proposal to be a key required development step for this technology to achieve prototype drilling, lining, and rock melting/ vaporization for creating sealing plugs.« less

Sulforaphane-stimulated phase II enzyme induction inhibits cytokine production by airway epithelial cells stimulated with diesel extract.

PubMed

Ritz, Stacey A; Wan, Junxiang; Diaz-Sanchez, David

2007-01-01

Airborne particulate pollutants, such as diesel exhaust particles, are thought to exacerbate lung and cardiovascular diseases through induction of oxidative stress. Sulforaphane, derived from cruciferous vegetables, is the most potent known inducer of phase II enzymes involved in the detoxification of xenobiotics. We postulated that sulforaphane may be able to ameliorate the adverse effects of pollutants by upregulating expression of endogenous antioxidant enzymes. Stimulation of bronchial epithelial cells with the chemical constituents of diesel particles result in the production of proinflammatory cytokines. We first demonstrated a role for phase II enzymes in regulating diesel effects by transfecting the airway epithelial cell line (BEAS-2B) with the sentinel phase II enzyme NAD(P)H: quinine oxidoreductase 1 (NQO1). IL-8 production in response to diesel extract was significantly reduced in these compared with untransfected cells. We then examined whether sulforaphane would stimulate phase II induction and whether this would thereby ablate the effect of diesel extracts on cytokine production. We verified that sulforaphane significantly augmented expression of the phase II enzyme genes GSTM1 and NQO1 and confirmed that sulforaphane treatment increased glutathione S-transferase activity in epithelial cells without inducing cell death or apoptosis. Sulforaphane pretreatment inhibited IL-8 production by BEAS-2B cells upon stimulation with diesel extract. Similarly, whereas diesel extract stimulated production of IL-8, granulocyte-macrophage colony-stimulating factor, and IL-1beta from primary human bronchial epithelial cells, sulforaphane pretreatment inhibited diesel-induced production of all of these cytokines. Our studies show that sulforaphane can mitigate the effect of diesel in respiratory epithelial cells and demonstrate the chemopreventative potential of phase II enzyme enhancement.

Three steps to writing adaptive study protocols in the early phase clinical development of new medicines

PubMed Central

2014-01-01

This article attempts to define terminology and to describe a process for writing adaptive, early phase study protocols which are transparent, self-intuitive and uniform. It provides a step by step guide, giving templates from projects which received regulatory authorisation and were successfully performed in the UK. During adaptive studies evolving data is used to modify the trial design and conduct within the protocol-defined remit. Adaptations within that remit are documented using non-substantial protocol amendments which do not require regulatory or ethical review. This concept is efficient in gathering relevant data in exploratory early phase studies, ethical and time- and cost-effective. PMID:24980283

Installation Restoration Program. Remedial Investigation Report. Minnesota Air National Guard Base Duluth International Airport, Duluth, Minnesota. Volume 5

DTIC Science & Technology

1990-01-01

1-20 1-6 Sites Defined and Ranked During IRP Phase I Study. 1-29 1-7 Aerial Photograph of Site 2, April 1988. 1-32 1-8 Site 2 Sampling Locations...Utilized During Phase II Investigations. 1-35 1-9 Aerial Photograph of Site 3, April 1988. 1-38 1-10 Site 3 Sampling Locations Utilized During Phase II...Investigations. 1-47 1-11 Aerial Photograph of Site 4, April 1988. 1-54 1-12 Site 4 Sampling Locations Utilized During Phase II Investigations. 1-57 1-13

Exploratory analysis of a phase III trial of pirfenidone identifies a subpopulation of patients with idiopathic pulmonary fibrosis as benefiting from treatment

PubMed Central

2011-01-01

Background A phase III trial in Japan showed that pirfenidone is effective for idiopathic pulmonary fibrosis (IPF). To find out which patients specifically benefit from pirfenidone, we analyzed in an exploratory manner the data from the phase III trial. Methods The patients in the phase III trial were stratified by baseline percentage predicted vital capacity (%VC), arterial oxygen partial pressure (PaO2), and the lowest oxygen saturation by pulse oximetry (SpO2) during the 6-minute steady-state exercise test (6MET). In the subpopulations, changes in VC and subjective symptoms (cough and dyspnea on the Fletcher, Hugh-Jones [F, H-J] Classification scale) were evaluated in patients treated with high-dose (1800 mg/day) pirfenidone, low-dose (1200 mg/day) pirfenidone, and placebo at week 52. Results Significant efficacy of pirfenidone in reducing the decline in VC could be seen in a subpopulation having %VC ≥ 70% and SpO2 < 90% at baseline. This favorable effect was accompanied by categorical change in VC and progression-free survival time. In the subpopulation, pirfenidone significantly suppressed cough and dyspnea. Conclusions IPF patients having %VC ≥ 70% and SpO2 < 90% at baseline will most likely benefit from pirfenidone when evaluated using changes in VC (and %VC), and cough and dyspnea symptoms. This subpopulation could expect to benefit most from pirfenidone treatment. Trial Registration This clinical trial was registered with the Japan Pharmaceutical Information Center (JAPIC) on September 13th, 2005 (Registration Number: JAPICCTI-050121). PMID:22035508

Piper betle Induced Cytoprotective Genes and Proteins via the Nrf2/ARE Pathway in Aging Mice.

PubMed

Aliahmat, Nor Syahida; Abdul Sani, Nur Fathiah; Wan Hasan, Wan Nuraini; Makpol, Suzana; Wan Ngah, Wan Zurinah; Mohd Yusof, Yasmin Anum

2016-01-01

The objective of this study was to elucidate the underlying antioxidant mechanism of aqueous extract of Piper betle (PB) in aging rats. The nuclear factor erythroid 2-related factor 2 (Nrf2)/ARE pathway involving phase II detoxifying and antioxidant enzymes plays an important role in the antioxidant system by reducing electrophiles and reactive oxygen species through induction of phase II enzymes and proteins. Genes and proteins of phase II detoxifying antioxidant enzymes were analyzed by QuantiGenePlex 2.0 Assay and Western blot analysis. PB significantly induced genes and proteins of phase II and antioxidant enzymes, NAD(P)H quinone oxidoreductase 1, and catalase in aging mice (p < 0.05). The expression of these enzymes were stimulated via translocation of Nrf2 into the nucleus, indicating the involvement of ARE, a cis-acting motif located in the promoter region of nearly all phase II genes. PB was testified for the first time to induce cytoprotective genes through the Nrf2/ARE signaling pathway, thus unraveling the antioxidant mechanism of PB during the aging process. © 2016 S. Karger AG, Basel.

Summary - National Dissemination and the Five Target States, Part 3, Final Report for Phase II--Dissemination, Rural Shared Services.

ERIC Educational Resources Information Center

Northern Montana Coll., Havre.

The dissemination phase (Phase II) of the Rural Shared Services Project is reported in this document. Efforts of the dissemination phase were concentrated in 5 target states: Vermont, Georgia, Wyoming, Montana, and New Mexico; national dissemination was limited to attendance at national conferences, the U. S. Office of Education PREP materials for…

Site preference of alloying elements in DO22-Ni3V phase: Phase-field and first-principles study

NASA Astrophysics Data System (ADS)

Zhang, Ding-Ni; Shangguan, Qian-Qian; Liu, Fu; Zhang, Ming-Yi

2015-07-01

Site preference of alloying elements in DO22-Ni3V phase was investigated using phase-field and first-principles method. The concentrations of alloying elements on sublattices of DO22-Ni3V phase were quantitatively studied using phase-field model based on microscopic diffusion equations. The phase-field computation results demonstrate that the concentration differences of alloying elements on the NiI and NiII site are attributed to the coordination environment difference. Host atoms Ni and substitutional ternary additions Al prefer to occupy NiI site. Antisite atoms V show site preference on the NiII site. Further reason of site preference of alloying elements on the two different Ni sites were studied using first-principles method to calculate the electronic structure of DO22-Ni3V phase. Calculation of density of states, orbitals population and charge population of the optimized Ni3V structure found that the electronic structures of NiI and NiII sites are different. Electronic structure difference, which is caused by coordination environment difference, is the essential reason for site selectivity behaviors of alloying elements on NiI and NiII sites.

Use of responder threshold criteria to evaluate the response to treatment in the phase III CHEST-1 study.

PubMed

D'Armini, Andrea M; Ghofrani, Hossein-Ardeschir; Kim, Nick H; Mayer, Eckhard; Morsolini, Marco; Pulido-Zamudio, Tomás; Simonneau, Gerald; Wilkins, Martin R; Curram, John; Davie, Neil; Hoeper, Marius M

2015-03-01

In the Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase - Stimulator Trial 1 (CHEST-1) study, riociguat improved 6-minute walking distance (6MWD) vs placebo in patients with inoperable chronic thromboembolic pulmonary hypertension or persistent/recurrent pulmonary hypertension after pulmonary endarterectomy. In this study, the proportion of patients who achieved responder thresholds that correlate with improved outcome in patients with pulmonary arterial hypertension was determined at baseline and at the end of CHEST-1. Patients received placebo or riociguat individually adjusted up to 2.5 mg 3 times a day for 16 weeks. Response criteria were defined as follows: 6MWD increase ≥40 m, 6MWD ≥380 m, cardiac index ≥2.5 liters/min/m(2), pulmonary vascular resistance <500 dyn∙sec∙cm(-5), mixed venous oxygen saturation ≥65%, World Health Organization functional class I/II, N-terminal pro-brain natriuretic peptide <1,800 pg/ml, and right atrial pressure <8 mm Hg. Riociguat increased the proportion of patients with 6MWD ≥380 m, World Health Organization functional class I/II, and pulmonary vascular resistance <500 dyn∙sec∙cm(-5) from 37%, 34%, and 25% at baseline to 58%, 57%, and 50% at Week 16, whereas there was little change in placebo-treated patients (6MWD ≥380 m, 43% vs 44%; World Health Organization functional class I/II, 29% vs 38%; pulmonary vascular resistance <500 dyn∙sec∙cm(-5), 27% vs 26%). Similar changes were observed for thresholds for cardiac index, mixed venous oxygen saturation, N-terminal pro-brain natriuretic peptide, and right atrial pressure. In this exploratory analysis, riociguat increased the proportion of patients with inoperable chronic thromboembolic pulmonary hypertension or persistent/recurrent pulmonary hypertension after pulmonary endarterectomy achieving criteria defining a positive response to therapy. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Computer Simulations of Polytetrafluoroethylene in the Solid State

NASA Astrophysics Data System (ADS)

Holt, D. B.; Farmer, B. L.; Eby, R. K.; Macturk, K. S.

1996-03-01

Force field parameters (Set I) for fluoropolymers were previously derived from MOPAC AM1 semiempirical data on model molecules. A second set (Set II) was derived from the AM1 results augmented by ab initio calculations. Both sets yield reasonable helical and phase II packing structures for polytetrafluoroethylene (PTFE) chains. However, Set I and Set II differ in the strength of van der Waals interactions, with Set II having deeper potential wells (order of magnitude). To differentiate which parameter set provides a better description of PTFE behavior, molecular dynamics simulations have been performed with Biosym Discover on clusters of PTFE chains which begin in a phase II packing environment. Added to the model are artificial constraints which allow the simulation of thermal expansion without having to define periodic boundary conditions for each specific temperature of interest. The preliminary dynamics simulations indicate that the intra- and intermolecular interactions provided by Set I are too weak. The degree of helical disorder and chain motion are high even at temperatures well below the phase II-phase IV transition temperature (19 C). Set II appears to yield a better description of PTFE in the solid state.

Instrument translation and initial psychometric evaluation of the Danish Body Image Quality of Life Inventory.

PubMed

Rasmussen, Trine Bernholdt; Berg, Selina Kikkenborg; Dixon, Jane; Moons, Philip; Konradsen, Hanne

2016-12-01

Negative body perception has been reported in a number of patient populations. No instrument in Danish for measuring body image-related concerns has been available. Without such an instrument, understanding of the phenomenon in Danish-speaking populations is limited. The purpose of the study was thus to translate and validate a Danish version of the Body Image Quality of Life Inventory (BIQLI), in order to obtain a valid instrument applicable for healthcare research. The study consisted of two phases: (i) instrument adaptation, including forward and back translation, expert committee comparisons and cognitive interviewing, and (ii) empirical testing of the Danish version (BIQLI-DA) with subsequent psychometric evaluation. Hypothesised correlations to other measures, including body mass index (BMI), Medical Outcome Short Form-8 (SF-8), Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder-7 and Symptom Check List-90-Revised (SCL-90-R ® ) were tested. In addition, exploratory factor structure analysis (EFA) and internal consistency on item and scale level were performed. The adapted instrument was found to be semantically sound, yet concerns about face validity did arise through cognitive interviews. Danish college students (n = 189, 65 men, M age = 21.1 years) participated in the piloting of the BIQLI-DA. Convergent construct validity was demonstrated through associations to related constructs. Exploratory factor analysis revealed a potential subscale structure. Finally, results showed a high internal consistency (Cronbach's alpha = 0.92). Support for the validity of the BIQLI-DA might have been strengthened by repeating cognitive interviews after layout alterations, by piloting the instrument on a larger sample. This study demonstrated tentative support for the validity of the Danish Body Image Quality of Life (BIQLI-DA) and found the measure to be reliable in terms of internal consistency. Further exploration of response processes and construct validity is needed. © 2016 Nordic College of Caring Science.

Design, analysis, and test verification of advanced encapsulation systems

NASA Technical Reports Server (NTRS)

Mardesich, N.; Minning, C.

1982-01-01

Design sensitivities are established for the development of photovoltaic module criteria and the definition of needed research tasks. The program consists of three phases. In Phase I, analytical models were developed to perform optical, thermal, electrical, and structural analyses on candidate encapsulation systems. From these analyses several candidate systems will be selected for qualification testing during Phase II. Additionally, during Phase II, test specimens of various types will be constructed and tested to determine the validity of the analysis methodology developed in Phase I. In Phse III, a finalized optimum design based on knowledge gained in Phase I and II will be developed. All verification testing was completed during this period. Preliminary results and observations are discussed. Descriptions of the thermal, thermal structural, and structural deflection test setups are included.

Technology Demonstration of the Zero Emissions Chromium Electroplating System

DTIC Science & Technology

2008-02-01

Phase I trivalent chromium results ................................................................... 23 18 Phase II total chromium in PRD fluid results...0 xa B D F H J L Sam pies Figure 16. Phase II iron results. ERDC/CERL TR-05-35, Vol. 1 23 Trivalent Chromium Phase I Analysis for Phase I was...with the samples. Each sample was analyzed twice, and an average was computed. Figure 17 shows the results. ANAD has specified that Trivalent Chromium

Laboratory modeling of energy dissipation in broken-back culverts - phase II.

DOT National Transportation Integrated Search

2011-05-01

This report represents Phase II of broken-back culverts with a drop of 6 feet. The first phase of this research was performed for a drop of 24 feet. This research investigates the reduction in scour downstream of a broken-back culvert by forming a hy...

DEVELOPMENT OF A SCALABLE, LOW-COST, ULTRANANOCRYSTALLINE DIAMOND ELECTROCHEMICAL PROCESS FOR THE DESTRUCTION OF CONTAMINANTS OF EMERGING CONCERN (CECS) - PHASE II

EPA Science Inventory

This Small Business Innovation Research (SBIR) Phase II project will employ the large scale; highly reliable boron-doped ultrananocrystalline diamond (BD-UNCD®) electrodes developed during Phase I project to build and test Electrochemical Anodic Oxidation process (EAOP)...

78 FR 18305 - Notice of Request for Extension of a Currently Approved Information Collection

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-26

... Identity Verification (PIV) Request for Credential, the USDA Homeland Security Presidential Directive 12... consists of two phases of implementation: Personal Identity Verification phase I (PIV I) and Personal Identity Verification phase II (PIV II). The information requested must be provided by Federal employees...

A two-step spin crossover mononuclear iron(II) complex with a [HS-LS-LS] intermediate phase.

PubMed

Bonnet, Sylvestre; Siegler, Maxime A; Costa, José Sánchez; Molnár, Gábor; Bousseksou, Azzedine; Spek, Anthony L; Gamez, Patrick; Reedijk, Jan

2008-11-21

The two-step spin crossover of a new mononuclear iron(ii) complex is studied by magnetic, crystallographic and calorimetric methods revealing two successive first-order phase transitions and an ordered intermediate phase built by the repetition of the unprecedented [HS-LS-LS] motif.

The effectiveness and safety of traffic and non-traffic related messages presented on changeable message signs : phase II.

DOT National Transportation Integrated Search

2008-08-01

In Phase II of this investigation, we used a fully interactive PC-based STISIM driving simulator, to conduct two : experiments which were similar to experiments in Phase I. The participants were 120 licensed drivers from three : age groups18-24, 3...

Tipster Text Phase 2 Architecture Design

DTIC Science & Technology

1996-06-19

TIPSTER Text Phase II Architecture Design Version 2.1p 19 June 1996 Ralph Grishman New York University grishman @cs.nyu.edu and the TIPSTER...1996 2. REPORT TYPE 3. DATES COVERED 00-00-1996 to 00-00-1996 4. TITLE AND SUBTITLE TIPSTER Text Phase II Architecture Design 5a. CONTRACT

Phase I/II trial of 2-weekly docetaxel combined with cisplatin plus fluorouracil in metastatic esophageal cancer (JCOG0807)

PubMed Central

Hironaka, Shuichi; Tsubosa, Yasuhiro; Mizusawa, Junki; Kii, Takayuki; Kato, Ken; Tsushima, Takahiro; Chin, Keisho; Tomori, Akihisa; Okuno, Tatsuya; Taniki, Toshikatsu; Ura, Takashi; Matsushita, Hisayuki; Kojima, Takashi; Doki, Yuichiro; Kusaba, Hitoshi; Fujitani, Kazumasa; Taira, Koichi; Seki, Shiko; Nakamura, Tsutomu; Kitagawa, Yuko

2014-01-01

We carried out a phase I/II trial of adding 2-weekly docetaxel to cisplatin plus fluorouracil (CF) therapy (2-weekly DCF regimen) in esophageal cancer patients to investigate its safety and antimetastatic activity. Patients received 2-weekly docetaxel (30 mg/m2 [dose level (DL)1] or 40 mg/m2 [DL2] with a 3 + 3 design in phase I, on days 1 and 15) in combination with fixed-dose CF (80 mg/m2 cisplatin, day 1; 800 mg/m2 fluorouracil, days 1–5) repeated every 4 weeks. The primary endpoint was dose-limiting toxicity (DLT) in phase I and central peer review-based response rate in phase II. At least 22 responders among 50 patients were required to satisfy the primary endpoint with a threshold of 35%. Sixty-two patients were enrolled in phase I and II. In phase I, 10 patients were enrolled with DLT of 0/3 at DL1 and 2/7 in DL2. Considering DLT and treatment compliance, the recommended phase II dose was determined as DL1. In phase II, the response rate was 62% (P < 0.0001; 95% confidence interval, 48–75%); median overall survival and progression-free survival were 11.1 and 5.8 months, respectively. Common grade 3/4 adverse events were neutropenia (25%), anemia (36%), hyponatremia (29%), anorexia (24%), and nausea (11%). No febrile neutropenia was observed. Pneumonitis caused treatment-related death in one patient. The 2-weekly DCF regimen showed promising antimetastatic activity and tolerability. A phase III study comparing this regimen with CF therapy is planned by the Japan Clinical Oncology Group. This study was registered at the UMIN Clinical Trials Registry as UMIN 000001737. PMID:25041052

Unusual Enhancement of Magnetization by Pressure in the Antiferro-Quadrupole-Ordered Phase in CeB6

NASA Astrophysics Data System (ADS)

Ikeda, Suguru; Sera, Masafumi; Hane, Shingo; Uwatoko, Yoshiya; Kosaka, Masashi; Kunii, Satoru

2007-06-01

The effect of pressure on CeB6 was investigated by the measurement of the magnetization (M) under pressure, and we obtained the following results. The effect of pressure on M in phase I is very small. By applying pressure, TQ is enhanced, but TN and the critical field from the antiferromagnetic (AFM) phase III to the antiferro-quadrupole (AFQ) phase II (HcIII--II) are suppressed, as previously reported. The magnetization curve in phase III shows the characteristic shoulder at H˜ HcIII--II/2 at ambient pressure. This shoulder becomes much more pronounced by applying pressure. Both HcIII--II and the magnetic field, where a shoulder is seen in the magnetization curve in phase III, are largely suppressed by pressure. In phase II, the M-T curve at a low magnetic field exhibits an unusual concave temperature dependence below TQ down to TN. Thus, we found that the lower the magnetic field, the larger the enhancement of M in both phases III and II. To clarify the origin of the unusual pressure effect of M, we performed a mean-field calculation for the 4-sublattice model using the experimental results of dTQ/dP>0 and dTN/dP<0 and assuming the positive pressure dependence of the Txyz-antiferro-octupole (AFO) interaction. The characteristic features of the pressure effect of M obtained by the experiments could be reproduced well by the mean-field calculation. We found that the origin of the characteristic effect of pressure on CeB6 is the change in the subtle balance between the AFM interaction and the magnetic field-induced-effective FM interaction induced by the coexistence of the Oxy-AFQ and Txyz-AFO interactions under pressure.

The A-Framework: The Role of Access, Attributes, and Affordance in the Adoption of Distance Education Technology for Lifestyle Change

ERIC Educational Resources Information Center

Tierney, Patrick J.; Moisey, Susan

2014-01-01

This exploratory mixed methods case study examined the use of distance education technology for lifestyle change within the context of obesity treatment and weight management. In the quantitative phase of the study, 19 adults involved in an obesity-related lifestyle change program or change process completed a questionnaire that determined their…

White Teenage Girls and Affirmative Action in Higher Education in South Africa

ERIC Educational Resources Information Center

Botsis, H.

2010-01-01

This is an initial and exploratory comment on the pilot phase of a study into adolescent female white identity and socio-sexual desire in post-apartheid South Africa. In the course of this pilot it became apparent that historical issues of race and racism are openly discussed in these girls' classrooms. Yet, despite these everyday interactions the…

Approach to Mathematical Problem Solving and Students' Belief Systems: Two Case Studies

ERIC Educational Resources Information Center

Callejo, Maria Luz; Vila, Antoni

2009-01-01

The goal of the study reported here is to gain a better understanding of the role of belief systems in the approach phase to mathematical problem solving. Two students of high academic performance were selected based on a previous exploratory study of 61 students 12-13 years old. In this study we identified different types of approaches to…

The Composition of Consideration and Choice Sets in Undergraduate University Choice: An Exploratory Study

ERIC Educational Resources Information Center

Dawes, Philip L.; Brown, Jennifer

2004-01-01

We examine university choice as a case of consumer decision making and adopt a brand elimination framework. This approach is predicated on the grounds that a large amount of research in consumer behavior has shown that in markets where there are many alternative brands, consumers use phased-decision strategies. In these research studies, the…

A Resource Guide for an Exploratory Curriculum for Three-Year Old Migrant Children.

ERIC Educational Resources Information Center

Hoffman, Stevie; Mottola, Niel

The rational for the curriculum design for three-year-old migrant children in an expanded-day educational program is presented. Consideration is given for each of the program phases, the learning environment, the rationale for a pre-service workshop and on-going in-service consultancy. This curriculum is based on the premise that, because of the…

Integration, acceptance testing, and clinical operation of the Medical Information, Communication and Archive System, phase II.

PubMed

Smith, E M; Wandtke, J; Robinson, A

1999-05-01

The Medical Information, Communication and Archive System (MICAS) is a multivendor incremental approach to picture archiving and communications system (PACS). It is a multimodality integrated image management system that is seamlessly integrated with the radiology information system (RIS). Phase II enhancements of MICAS include a permanent archive, automated workflow, study caches, Microsoft (Redmond, WA) Windows NT diagnostic workstations with all components adhering to Digital Information Communications in Medicine (DICOM) standards. MICAS is designed as an enterprise-wide PACS to provide images and reports throughout the Strong Health healthcare network. Phase II includes the addition of a Cemax-Icon (Fremont, CA) archive, PACS broker (Mitra, Waterloo, Canada), an interface (IDX PACSlink, Burlington, VT) to the RIS (IDXrad) plus the conversion of the UNIX-based redundant array of inexpensive disks (RAID) 5 temporary archives in phase I to NT-based RAID 0 DICOM modality-specific study caches (ImageLabs, Bedford, MA). The phase I acquisition engines and workflow management software was uninstalled and the Cemax archive manager (AM) assumed these functions. The existing ImageLabs UNIX-based viewing software was enhanced and converted to an NT-based DICOM viewer. Installation of phase II hardware and software and integration with existing components began in July 1998. Phase II of MICAS demonstrates that a multivendor open-system incremental approach to PACS is feasible, cost-effective, and has significant advantages over a single-vendor implementation.

Chemoradiation in elderly esophageal cancer patients: rationale and design of a phase I/II multicenter study (OSAGE).

PubMed

Servagi-Vernat, Stéphanie; Créhange, Gilles; Bonnetain, Franck; Mertens, Cécile; Brain, Etienne; Bosset, Jean François

2017-07-13

The management of elderly patients with cancer is a therapeutic challenge and a public health problem. Definitive chemoradiotherapy (CRT) is an accepted standard treatment for patients with locally advanced esophageal cancer who cannot undergo surgery. However, there are few reports regarding tolerance to CRT in elderly patients. We previously reported results for CRT in patients aged ≥75 years. Following this first phase II trial, we propose to conduct a phase I/II study to evaluate the combination of carboplatin and paclitaxel, with concurrent RT in unresectable esophageal cancer patients aged 75 years or older. This prospective multicenter phase I/II study will include esophageal cancer in patients aged 75 years or older. Study procedures will consist to determinate the tolerated dose of chemotherapy (Carboplatin, paclitaxel) and of radiotherapy (41.4-45 and 50.4 Gy) in the phase I. Efficacy will be assessed using a co-primary endpoint encompassing health related quality of life and the progression-free survival in the phase II with the dose recommended of CRT in the phase I. This geriatric evaluation was defined by the French geriatric oncology group (GERICO). This trial has been designed to assess the tolerated dose of CRT in selected patient aged 75 years or older. Clinicaltrials.gov ID: NCT02735057 . Registered on 18 March 2016.

Geraniol modulates tongue and hepatic phase I and phase II conjugation activities and may contribute directly to the chemopreventive activity against experimental oral carcinogenesis.

PubMed

Madankumar, Arumugam; Jayakumar, Subramaniyan; Gokuladhas, Krishnan; Rajan, Balan; Raghunandhakumar, Subramanian; Asokkumar, Selvamani; Devaki, Thiruvengadam

2013-04-05

Xenobiotic metabolizing enzymes are chief determinants in both the susceptibility to mutagenic effect of chemical carcinogens and in the response of tumors to chemotherapy. The present study was aimed to analyze the effect of geraniol administration on the activity of phase I and phase II carcinogen metabolizing enzymes through the nuclear factor erythroid 2-related factor-2 (Nrf2) activation against 4-niroquinoline-1-oxide (4NQO) induced oral carcinogenesis. The well-known chemical carcinogen 4NQO (50 ppm) was used to induce oral carcinogenesis through drinking water for 4, 12, and 20 weeks. The degree of cancer progression at each stage was confirmed by histological examination. At the end of the experimental period, 100% tumor formation was observed in the oral cavity of 4NQO induced animals with significant (P<0.05) alteration in the status of tumor markers, tongue and liver phase I and phase II drug metabolizing enzymes indicating progression of disease. Oral administration of geraniol at the dose of 200 mg/kg b.wt., thrice a week to 4NQO induced animals was able to inhibit tumor formation and thereby delayed the progression of oral carcinogenesis by modulating tongue and liver phase I and phase II drug metabolizing enzymes, as substantiated further by the histological and transmission electron microscopic studies. Our results demonstrate that geraniol exerts its chemopreventive potential by altering activities of phases I and II drug metabolizing enzymes to achieve minimum bioactivation of carcinogen and maximum detoxification. Copyright © 2013 Elsevier B.V. All rights reserved.

High Energy Laser Technology Assessment: Volume 1. The Technology Assessment: An Initial Study

DTIC Science & Technology

1975-01-01

technically feasible and economically cost effective Such an analysis is beyord the capability of this exploratory study Therefore, to proceed with... Analysis R&D Management fffft jygJfQ JQ Q^^ 20 ABSTRACT fConllnu* im r«»«ra« •!«#• II ifcmmnmrr mt4 Idtmllty hf Heck A technology assessment ha...by an abreviated impact analysis whose intent is to be illustrative of the methodology, rather than be a comprehensive treatment of the subject. 00

A comparison of three approaches for simulating fine-scale surface winds in support of wildland fire management. Part II. An exploratory study of the effect of simulated winds on fire growth simulations

Treesearch

Jason M. Forthofer; Bret W. Butler; Charles W. McHugh; Mark A. Finney; Larry S. Bradshaw; Richard D. Stratton; Kyle S. Shannon; Natalie S. Wagenbrenner

2014-01-01

The effect of fine-resolution wind simulations on fire growth simulations is explored. The wind models are (1) a wind field consisting of constant speed and direction applied everywhere over the area of interest; (2) a tool based on the solution of the conservation of mass only (termed mass-conserving model) and (3) a tool based on a solution of conservation of mass...

Bioengineered Temporomandibular Joint Disk Implants: Study Protocol for a Two-Phase Exploratory Randomized Preclinical Pilot Trial in 18 Black Merino Sheep (TEMPOJIMS)

PubMed Central

Monje, Florencio Gil; González-García, Raúl; Little, Christopher B; Mónico, Lisete; Pinho, Mário; Santos, Fábio Abade; Carrapiço, Belmira; Gonçalves, Sandra Cavaco; Morouço, Pedro; Alves, Nuno; Moura, Carla; Wang, Yadong; Jeffries, Eric; Gao, Jin; Sousa, Rita; Neto, Lia Lucas; Caldeira, Daniel; Salvado, Francisco

2017-01-01

Background Preclinical trials are essential to test efficacious options to substitute the temporomandibular joint (TMJ) disk. The contemporary absence of an ideal treatment for patients with severe TMJ disorders can be related to difficulties concerning the appropriate study design to conduct preclinical trials in the TMJ field. These difficulties can be associated with the use of heterogeneous animal models, the use of the contralateral TMJ as control, the absence of rigorous randomized controlled preclinical trials with blinded outcomes assessors, and difficulties involving multidisciplinary teams. Objective This study aims to develop a new, reproducible, and effective study design for preclinical research in the TMJ domain, obtaining rigorous data related to (1) identify the impact of bilateral discectomy in black Merino sheep, (2) identify the impact of bilateral discopexy in black Merino sheep, and (3) identify the impact of three different bioengineering TMJ discs in black Merino sheep. Methods A two-phase exploratory randomized controlled preclinical trial with blinded outcomes is proposed. In the first phase, nine sheep are randomized into three different surgical bilateral procedures: bilateral discectomy, bilateral discopexy, and sham surgery. In the second phase, nine sheep are randomized to bilaterally test three different TMJ bioengineering disk implants. The primary outcome is the histological gradation of TMJ. Secondary outcomes are imaging changes, absolute masticatory time, ruminant time per cycle, ruminant kinetics, ruminant area, and sheep weight. Results Previous preclinical studies in this field have used the contralateral unoperated side as a control, different animal models ranging from mice to a canine model, with nonrandomized, nonblinded and uncontrolled study designs and limited outcomes measures. The main goal of this exploratory preclinical protocol is to set a new standard for future preclinical trials in oromaxillofacial surgery, particularly in the TMJ field, by proposing a rigorous design in black Merino sheep. The authors also intend to test the feasibility of pilot outcomes. The authors expect to increase the quality of further studies in this field and to progress in future treatment options for patients undergoing surgery for TMJ disk replacement. Conclusions The study has commenced, but it is too early to provide results or conclusions. PMID:28254733

Polymorphism of paracetamol: relative stabilities of the monoclinic and orthorhombic phases inferred from topological pressure-temperature and temperature-volume phase diagrams.

PubMed

Espeau, Philippe; Céolin, René; Tamarit, Josep-Lluis; Perrin, Marc-Antoine; Gauchi, Jean-Pierre; Leveiller, Franck

2005-03-01

The thermodynamic relationships between the two known polymorphs of paracetamol have been investigated, and the subsequent pressure-temperature and temperature-volume phase diagrams were constructed using data from crystallographic and calorimetric measurements as a function of the temperature. Irrespective of temperature, monoclinic Form I and orthorhombic Form II are stable phases at ordinary and high pressures, respectively. The I and II phase regions in the pressure-temperature diagram are bordered by the I-II equilibrium curve, for which a negative slope (dp/dT approximately -0.3 MPa x K(-1)) was determined although it was not observed experimentally. This curve goes through the I-II-liquid triple point whose coordinates (p approximately 234 MPa, T approximately 505 K) correspond to the crossing point of the melting curves, for which dp/dT values of +3.75 MPa x K(-1) (I) and +3.14 MPa x K(-1) (II) were calculated from enthalpy and volume changes upon fusion. More generally, this case exemplifies how the stability hierarchy of polymorphs may be inferred from the difference in their sublimation curves, as topologically positioned with respect to each other, using the phase rule and simple inferences resorting to Gibbs equilibrium thermodynamics. Copyright 2004 Wiley-Liss, Inc. and the American Pharmacists Association.

Randomized Phase III Placebo-Controlled Trial of Letrozole Plus Oral Temsirolimus As First-Line Endocrine Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

PubMed Central

Wolff, Antonio C.; Lazar, Ann A.; Bondarenko, Igor; Garin, August M.; Brincat, Stephen; Chow, Louis; Sun, Yan; Neskovic-Konstantinovic, Zora; Guimaraes, Rodrigo C.; Fumoleau, Pierre; Chan, Arlene; Hachemi, Soulef; Strahs, Andrew; Cincotta, Maria; Berkenblit, Anna; Krygowski, Mizue; Kang, Lih Lisa; Moore, Laurence; Hayes, Daniel F.

2013-01-01

Purpose Recent data showed improvement in progression-free survival (PFS) when adding everolimus to exemestane in patients with advanced breast cancer experiencing recurrence/progression after nonsteroidal aromatase inhibitor (AI) therapy. Here, we report clinical outcomes of combining the mammalian target of rapamycin (mTOR) inhibitor temsirolimus with letrozole in AI-naive patients. Patients and Methods This phase III randomized placebo-controlled study tested efficacy/safety of first-line oral letrozole 2.5 mg daily/temsirolimus 30 mg daily (5 days every 2 weeks) versus letrozole/placebo in 1,112 patients with AI-naive, hormone receptor–positive advanced disease. An independent data monitoring committee recommended study termination for futility at the second preplanned interim analysis (382 PFS events). Results Patients were balanced (median age, 63 years; 10% stage III, 40% had received adjuvant endocrine therapy). Those on letrozole/temsirolimus experienced more grade 3 to 4 events (37% v 24%). There was no overall improvement in primary end point PFS (median, 9 months; hazard ratio [HR], 0.90; 95% CI, 0.76 to 1.07; P = .25) nor in the 40% patient subset with prior adjuvant endocrine therapy. An exploratory analysis showed improved PFS favoring letrozole/temsirolimus in patients ≤ age 65 years (9.0 v 5.6 months; HR, 0.75; 95% CI, 0.60 to 0.93; P = .009), which was separately examined by an exploratory analysis of 5-month PFS using subpopulation treatment effect pattern plot methodology (P = .003). Conclusion Adding temsirolimus to letrozole did not improve PFS as first-line therapy in patients with AI-naive advanced breast cancer. Exploratory analyses of benefit in younger postmenopausal patients require external confirmation. PMID:23233719

Development of scales to assess patients' perception of physicians' cultural competence in health care interactions.

PubMed

Ahmed, Rukhsana; Bates, Benjamin R

2012-07-01

This study describes the development of scales to measure patients' perception of physicians' cultural competence in health care interactions and thus contributes to promoting awareness of physician-patient intercultural interaction processes. Surveys were administrated to a total of 682 participants. Exploratory factor analyses were employed to assess emergent scales and subscales to develop reliable instruments. The first two phases were devoted to formative research and pilot study. The third phase was devoted to scale development, which resulted in a five-factor solution to measure patient perception of physicians' cultural competence for patient satisfaction.

GeoGIS : phase II.

DOT National Transportation Integrated Search

2009-12-01

A new web-based geotechnical Geographic Information System (GeoGIS) was developed and tested for the Alabama Department of Transportation (ALDOT) during Phase II of this research project. This web-based system stores geotechnical information about tr...

Hazardous Materials Routing Study Phase II: Analysis of Hazardous Materials Truck Routes in Proximity to the Dallas Central Business District

DOT National Transportation Integrated Search

1985-10-01

This report summarizes the findings from the second phase of a two-part analysis of hazardous materials truck routes in the Dallas-Fort Worth area. Phase II of this study analyzes the risk of transporting hazardous materials on freeways and arterial ...

75 FR 4894 - Self-Regulatory Organizations; National Securities Clearing Corporation; Notice of Filing and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-29

... activity.\\5\\ There will also be an increase in the monthly fee for the mutual fund Profile Phase II Service.... Profile Phase I transmits mutual fund price and rate information. Profile Phase II stores data elements such as accumulation, breakpoints, and commission eligibility that relate to mutual fund processing...

DEMONSTRATION OF FUEL CELLS TO RECOVER ENERGY FROM LANDFILL GAS: PHASE II. PRETREATMENT SYSTEM PERFORMANCE MEASUREMENT

EPA Science Inventory

The report describes Phase II of a demonstration of the utilization of commercial phosphoric acid fuel cells to recover energy from landfill gas. This phase consisted primarily of the construction and testing of a Gas Pretreatment Unit (GPU) whose function is to remove those impu...

Characterization of unpaved road condition through the use of remote sensing project - phase II, deliverable 8-D: final report.

DOT National Transportation Integrated Search

2016-03-07

Building on the success of developing a UAV based unpaved road assessment system in Phase I, the project team was awarded a Phase II project by the USDOT to focus on outreach and implementation. The project team added Valerie Lefler of Integrated Glo...

A Reliability Simulator for Radiation-Hard Microelectronics Development

DTIC Science & Technology

1991-07-01

1 3.0 PHASE II WORK PLANS ................................................................ 2... plan . The correlation experimental details including the devices utilized, the hot-carrier stressing and the wafer-level radiation correlation procedure...channel devices, and a new lifetime extrapolation method is demonstrated for p-channel devices. 3.0 PHASE II WORK PLANS The Phase 1I program consisted of

New York State Educational Information System (NYSEIS) Systems Design. Volume I, Phase II. Final Report.

ERIC Educational Resources Information Center

Price Waterhouse and Co., New York, NY.

This volume on Phase II of the New York State Educational Information System (NYSEIS) describes the Gross Systems Analysis and Design, which includes the general flow diagram and processing chart for each of the student, personnel, and financial subsystems. Volume II, Functional Specifications, includes input/output requirements and file…

Objective Lightning Probability Forecasting for Kennedy Space Center and Cape Canaveral Air Force Station, Phase III

NASA Technical Reports Server (NTRS)

Crawford, Winifred C.

2010-01-01

The AMU created new logistic regression equations in an effort to increase the skill of the Objective Lightning Forecast Tool developed in Phase II (Lambert 2007). One equation was created for each of five sub-seasons based on the daily lightning climatology instead of by month as was done in Phase II. The assumption was that these equations would capture the physical attributes that contribute to thunderstorm formation more so than monthly equations. However, the SS values in Section 5.3.2 showed that the Phase III equations had worse skill than the Phase II equations and, therefore, will not be transitioned into operations. The current Objective Lightning Forecast Tool developed in Phase II will continue to be used operationally in MIDDS. Three warm seasons were added to the Phase II dataset to increase the POR from 17 to 20 years (1989-2008), and data for October were included since the daily climatology showed lightning occurrence extending into that month. None of the three methods tested to determine the start of the subseason in each individual year were able to discern the start dates with consistent accuracy. Therefore, the start dates were determined by the daily climatology shown in Figure 10 and were the same in every year. The procedures used to create the predictors and develop the equations were identical to those in Phase II. The equations were made up of one to three predictors. TI and the flow regime probabilities were the top predictors followed by 1-day persistence, then VT and Ll. Each equation outperformed four other forecast methods by 7-57% using the verification dataset, but the new equations were outperformed by the Phase II equations in every sub-season. The reason for the degradation may be due to the fact that the same sub-season start dates were used in every year. It is likely there was overlap of sub-season days at the beginning and end of each defined sub-season in each individual year, which could very well affect equation performance.

A randomized phase II/III study of cabazitaxel versus vinflunine in metastatic or locally advanced transitional cell carcinoma of the urothelium (SECAVIN).

PubMed

Bellmunt, J; Kerst, J M; Vázquez, F; Morales-Barrera, R; Grande, E; Medina, A; González Graguera, M B; Rubio, G; Anido, U; Fernández Calvo, O; González-Billalabeitia, E; Van den Eertwegh, A J M; Pujol, E; Perez-Gracia, J L; González Larriba, J L; Collado, R; Los, M; Maciá, S; De Wit, R

2017-07-01

Despite the advent of immunotherapy in urothelial cancer, there is still a need to find effective cytotoxic agents beyond first and second lines. Vinflunine is the only treatment approved in this setting by the European Medicines Agency and taxanes are also widely used in second line. Cabazitaxel is a taxane with activity in docetaxel-refractory cancers. A randomized study was conducted to compare its efficacy versus vinflunine. This is a multicenter, randomized, open-label, phase II/III study, following a Simon's optimal method with stopping rules based on an interim futility analysis and a formal efficacy analysis at the end of the phase II. ECOG Performance Status, anaemia and liver metastases were stratification factors. Primary objectives were overall response rate for the phase II and overall survival for the phase III. Seventy patients were included in the phase II across 19 institutions in Europe. Baseline characteristics were well balanced between the two arms. Three patients (13%) obtained a partial response on cabazitaxel (95% CI 2.7-32.4) and six patients (30%) in the vinflunine arm (95% CI 11.9-54.3). Median progression-free survival for cabazitaxel was 1.9 versus 2.9 months for vinflunine (P = 0.039). The study did not proceed to phase III since the futility analysis showed a lack of efficacy of cabazitaxel. A trend for overall survival benefit was found favouring vinflunine (median 7.6 versus 5.5 months). Grade 3- to 4-related adverse events were seen in 41% patients with no difference between the two arms. This phase II/III second line bladder study comparing cabazitaxel with vinflunine was closed when the phase II showed a lack of efficacy of the cabazitaxel arm. Vinflunine results were consistent with those known previously. NCT01830231. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Phase I to II cross-induction of xenobiotic metabolizing enzymes: a feedforward control mechanism for potential hormetic responses.

PubMed

Zhang, Qiang; Pi, Jingbo; Woods, Courtney G; Andersen, Melvin E

2009-06-15

Hormetic responses to xenobiotic exposure likely occur as a result of overcompensation by the homeostatic control systems operating in biological organisms. However, the mechanisms underlying overcompensation that leads to hormesis are still unclear. A well-known homeostatic circuit in the cell is the gene induction network comprising phase I, II and III metabolizing enzymes, which are responsible for xenobiotic detoxification, and in many cases, bioactivation. By formulating a differential equation-based computational model, we investigated in this study whether hormesis can arise from the operation of this gene/enzyme network. The model consists of two feedback and one feedforward controls. With the phase I negative feedback control, xenobiotic X activates nuclear receptors to induce cytochrome P450 enzyme, which bioactivates X into a reactive metabolite X'. With the phase II negative feedback control, X' activates transcription factor Nrf2 to induce phase II enzymes such as glutathione S-transferase and glutamate cysteine ligase, etc., which participate in a set of reactions that lead to the metabolism of X' into a less toxic conjugate X''. The feedforward control involves phase I to II cross-induction, in which the parent chemical X can also induce phase II enzymes directly through the nuclear receptor and indirectly through transcriptionally upregulating Nrf2. As a result of the active feedforward control, a steady-state hormetic relationship readily arises between the concentrations of the reactive metabolite X' and the extracellular parent chemical X to which the cell is exposed. The shape of dose-response evolves over time from initially monotonically increasing to J-shaped at the final steady state-a temporal sequence consistent with adaptation-mediated hormesis. The magnitude of the hormetic response is enhanced by increases in the feedforward gain, but attenuated by increases in the bioactivation or phase II feedback loop gains. Our study suggests a possibly common mechanism for the hormetic responses observed with many mutagens/carcinogens whose activities require bioactivation by phase I enzymes. Feedforward control, often operating in combination with negative feedback regulation in a homeostatic system, may be a general control theme responsible for steady-state hormesis.

Physics Metacognition Inventory Part II: Confirmatory factor analysis and Rasch analysis

NASA Astrophysics Data System (ADS)

Taasoobshirazi, Gita; Bailey, MarLynn; Farley, John

2015-11-01

The Physics Metacognition Inventory was developed to measure physics students' metacognition for problem solving. In one of our earlier studies, an exploratory factor analysis provided evidence of preliminary construct validity, revealing six components of students' metacognition when solving physics problems including knowledge of cognition, planning, monitoring, evaluation, debugging, and information management. The college students' scores on the inventory were found to be reliable and related to students' physics motivation and physics grade. However, the results of the exploratory factor analysis indicated that the questionnaire could be revised to improve its construct validity. The goal of this study was to revise the questionnaire and establish its construct validity through a confirmatory factor analysis. In addition, a Rasch analysis was applied to the data to better understand the psychometric properties of the inventory and to further evaluate the construct validity. Results indicated that the final, revised inventory is a valid, reliable, and efficient tool for assessing student metacognition for physics problem solving.

Fe(II) sorption on pyrophyllite: Effect of structural Fe(III) (impurity) in pyrophyllite on nature of layered double hydroxide (LDH) secondary mineral formation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Starcher, Autumn N.; Li, Wei; Kukkadapu, Ravi K.

Fe(II)-Al(III)-LDH (layered double hydroxide) phases have been shown to form from reactions of aqueous Fe(II) with Fe-free Al-bearing minerals (phyllosilicate/clays and Al-oxides). To our knowledge, the effect of small amounts of structural Fe(III) impurities in “neutral” clays on such reactions, however, were not studied. In this study to understand the role of structural Fe(III) impurity in clays, laboratory batch studies with pyrophyllite (10 g/L), an Al-bearing phyllosilicate, containing small amounts of structural Fe(III) impurities and 0.8 mM and 3 mM Fe(II) (both natural and enriched in 57Fe) were carried out at pH 7.5 under anaerobic conditions (4% H2 – 96%more » N2 atmosphere). Samples were taken up to 4 weeks for analysis by Fe-X-ray absorption spectroscopy and 57Fe Mössbauer spectroscopy. In addition to the precipitation of Fe(II)-Al(III)-LDH phases as observed in earlier studies with pure minerals (no Fe(III) impurities in the minerals), the analyses indicated formation of small amounts of Fe(III) containing solid(s), most probably hybrid a Fe(II)-Al(III)/Fe(III)-LDH phase. The mechanism of Fe(II) oxidation was not apparent but most likely was due to interfacial electron transfer from the sorbed Fe(II) to the structural Fe(III) and/or surface-sorption-induced electron-transfer from the sorbed Fe(II) to the clay lattice. Increase in the Fe(II)/Al ratio of the LDH with reaction time further indicated the complex nature of the samples. This research provides evidence for the formation of both Fe(II)-Al(III)-LDH and Fe(II)-Fe(III)/Al(III)-LDH-like phases during reactions of Fe(II) in systems that mimic the natural environments. Better understanding Fe phase formation in complex laboratory studies will improve models of natural redox systems.« less

Anal Cancer: An Examination of Radiotherapy Strategies

DOE Office of Scientific and Technical Information (OSTI.GOV)

Glynne-Jones, Rob; Lim, Faye

2011-04-01

The Radiation Therapy Oncology Group 9811, ACCORD-03, and ACT II Phase III trials in anal cancer showed no benefit for cisplatin-based induction and maintenance chemotherapy, or radiation dose-escalation >59 Gy. This review examines the efficacy and toxicity of chemoradiation (CRT) in anal cancer, and discusses potential alternative radiotherapy strategies. The evidence for the review was compiled from randomized and nonrandomized trials of radiation therapy and CRT. A total of 103 retrospective/observational studies, 4 Phase I/II studies, 16 Phase II prospective studies, 2 randomized Phase II studies, and 6 Phase III trials of radiotherapy or chemoradiation were identified. There are nomore » meta-analyses based on individual patient data. A 'one-size-fits-all' approach for all stages of anal cancer is inappropriate. Early T1 tumors are probably currently overtreated, whereas T3/T4 lesions might merit escalation of treatment. Intensity-modulated radiotherapy or the integration of biological therapy may play a role in future.« less

Structures and phase transitions in a new ferroelectric -- pyridinium chlorochromate -- studied by X-ray diffraction, DSC and dielectric methods.

PubMed

Małuszyńska, Hanna; Czarnecki, Piotr; Czarnecka, Anna; Pająk, Zdzisław

2012-04-01

Pyridinium chlorochromate, [C(5)H(5)NH](+)[ClCrO(3)](-) (hereafter referred to as PyClCrO(3)), was studied by X-ray diffraction, differential scanning calorimetry (DSC) and dielectric methods. Studies reveal three reversible phase transitions at 346, 316 and 170 K with the following phase sequence: R ̅3m (I) → R3m (II) → Cm (III) → Cc (IV), c' = 2c. PyClCrO(3) is the first pyridinium salt in which all four phases have been successfully characterized by a single-crystal X-ray diffraction method. Structural results together with dielectric and calorimetric studies allow the classification of the two intermediate phases (II) and (III) as ferroelectric with the Curie point at 346 K, and the lowest phase (IV) as most probably ferroelectric. The ferroelectric hysteresis loop was observed only in phase (III). The high ionic conductivity hindered its observation in phase (II).

Statistical aspects of the TNK-S2B trial of tenecteplase versus alteplase in acute ischemic stroke: an efficient, dose-adaptive, seamless phase II/III design.

PubMed

Levin, Bruce; Thompson, John L P; Chakraborty, Bibhas; Levy, Gilberto; MacArthur, Robert; Haley, E Clarke

2011-08-01

TNK-S2B, an innovative, randomized, seamless phase II/III trial of tenecteplase versus rt-PA for acute ischemic stroke, terminated for slow enrollment before regulatory approval of use of phase II patients in phase III. (1) To review the trial design and comprehensive type I error rate simulations and (2) to discuss issues raised during regulatory review, to facilitate future approval of similar designs. In phase II, an early (24-h) outcome and adaptive sequential procedure selected one of three tenecteplase doses for phase III comparison with rt-PA. Decision rules comparing this dose to rt-PA would cause stopping for futility at phase II end, or continuation to phase III. Phase III incorporated two co-primary hypotheses, allowing for a treatment effect at either end of the trichotomized Rankin scale. Assuming no early termination, four interim analyses and one final analysis of 1908 patients provided an experiment-wise type I error rate of <0.05. Over 1,000 distribution scenarios, each involving 40,000 replications, the maximum type I error in phase III was 0.038. Inflation from the dose selection was more than offset by the one-half continuity correction in the test statistics. Inflation from repeated interim analyses was more than offset by the reduction from the clinical stopping rules for futility at the first interim analysis. Design complexity and evolving regulatory requirements lengthened the review process. (1) The design was innovative and efficient. Per protocol, type I error was well controlled for the co-primary phase III hypothesis tests, and experiment-wise. (2a) Time must be allowed for communications with regulatory reviewers from first design stages. (2b) Adequate type I error control must be demonstrated. (2c) Greater clarity is needed on (i) whether this includes demonstration of type I error control if the protocol is violated and (ii) whether simulations of type I error control are acceptable. (2d) Regulatory agency concerns that protocols for futility stopping may not be followed may be allayed by submitting interim analysis results to them as these analyses occur.

The Systems Approach to Functional Job Analysis. Task Analysis of the Physician's Assistant: Volume II--Curriculum and Phase I Basic Core Courses and Volume III--Phases II and III--Clinical Clerkships and Assignments.

ERIC Educational Resources Information Center

Wake Forest Univ., Winston Salem, NC. Bowman Gray School of Medicine.

This publication contains a curriculum developed through functional job analyses for a 24-month physician's assistant training program. Phase 1 of the 3-phase program is a 6-month basic course program in clinical and bioscience principles and is required of all students regardless of their specialty interest. Phase 2 is a 6 to 10 month period of…

Exploratory factor analysis of borderline personality disorder criteria in hospitalized adolescents.

PubMed

Becker, Daniel F; McGlashan, Thomas H; Grilo, Carlos M

2006-01-01

The authors examined the factor structure of borderline personality disorder (BPD) in hospitalized adolescents and also sought to add to the theoretical and clinical understanding of any homogeneous components by determining whether they may be related to specific forms of Axis I pathology. Subjects were 123 adolescent inpatients, who were reliably assessed with structured diagnostic interviews for Diagnostic and Statistical Manual of Mental Disorders, Revised Third Edition Axes I and II disorders. Exploratory factor analysis identified BPD components, and logistic regression analyses tested whether these components were predictive of specific Axis I disorders. Factor analysis revealed a 4-factor solution that accounted for 67.0% of the variance. Factor 1 ("suicidal threats or gestures" and "emptiness or boredom") predicted depressive disorders and alcohol use disorders. Factor 2 ("affective instability," "uncontrolled anger," and "identity disturbance") predicted anxiety disorders and oppositional defiant disorder. Factor 3 ("unstable relationships" and "abandonment fears") predicted only anxiety disorders. Factor 4 ("impulsiveness" and "identity disturbance") predicted conduct disorder and substance use disorders. Exploratory factor analysis of BPD criteria in adolescent inpatients revealed 4 BPD factors that appear to differ from those reported for similar studies of adults. The factors represent components of self-negation, irritability, poorly modulated relationships, and impulsivity--each of which is associated with characteristic Axis I pathology. These findings shed light on the nature of BPD in adolescents and may also have implications for treatment.

Understanding Pasifika youth and the obesogenic environment, Auckland and Wellington, New Zealand.

PubMed

Tupai-Firestone, Ridvan; Tuisano, Hana; Manukia, Moana; Kaholokula, Keawe'aimoku; Foliaki, Sunia; Kingi, Te Kani; Kruger, Rozanne; Breier, Bernhard; O'Connell, Angelique; Kruger, Rozanne; Borman, Barry; Ellison-Loschmann, Lis

2016-05-06

In New Zealand, the burden of obesity is greatest among Pacific people, especially in children and adolescents. We investigated the factors of the obesogenic environment that were indigenous to Pasifika youths' social-cultural context, their food purchasing behaviours, and associated anthropometric measures. An exploratory study of 30 Pasifika youth aged 16-24 years in Wellington and Auckland, New Zealand. A large proportion of the participants were obese (mean body mass index: 31.0kg/m2; waistto-hip ratio: 0.84; waist-to-height ratio: 0.6), suggesting that the future health and wellbeing trajectory of the studied Pasifika youth is poor. Purchasing behaviours of food and snacks over a 7-day period provided meaningful insights that could be a useful future research tool to examine the role of their physical environment on food access and availability. From this exploratory study, we highlight the following: (i) the future health trajectory of Pasifika youth is poor. Developing the youths' healthy lifestyle knowledge may lend itself to developing culturally relevant intervention programmes; (ii) identifying the enablers and barriers within the Pasifika ontext of an obesogenic environment can provide very useful information; (iii) use of spatial analysis using purchased food receipts adds to the current knowledge base of obesity-related research, although this was an exploratory investigation. We need to address these highlights if we are to reverse the trend of obesity for this population.

47 CFR 90.765 - Licenses term for Phase II licenses.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 220-222 MHz Band Policies Governing the Licensing and Use of Phase II Ea, Regional and Nationwide...(a), EA and Regional licenses authorized pursuant to § 90.761, and non-nationwide licenses authorized...

47 CFR 90.765 - Licenses term for Phase II licenses.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 220-222 MHz Band Policies Governing the Licensing and Use of Phase II Ea, Regional and Nationwide...(a), EA and Regional licenses authorized pursuant to § 90.761, and non-nationwide licenses authorized...

Planning Targets for Phase II Watershed Implementation Plans

EPA Pesticide Factsheets

On August 1, 2011, EPA provided planning targets for nitrogen, phosphorus and sediment for the Phase II Watershed Implementation Plans (WIPs) of the Chesapeake Bay TMDL. This page provides the letters containing those planning targets.

Sears Point Tidal Marsh Restoration Project: Phase II

EPA Pesticide Factsheets

Information about the SFBWQP Sears Point Tidal Marsh Restoration Project: Phase II, part of an EPA competitive grant program to improve SF Bay water quality focused on restoring impaired waters and enhancing aquatic resources.

Randomized Phase II Trial of Seribantumab in Combination With Paclitaxel in Patients With Advanced Platinum-Resistant or -Refractory Ovarian Cancer

PubMed Central

Ray-Coquard, Isabelle; Selle, Frederic; Poveda, Andrés M.; Cibula, David; Hirte, Hal; Hilpert, Felix; Raspagliesi, Francesco; Gladieff, Laurence; Harter, Philipp; Siena, Salvatore; del Campo, Josep Maria; Tabah-Fisch, Isabelle; Pearlberg, Joseph; Moyo, Victor; Riahi, Kaveh; Nering, Rachel; Kubasek, William; Adiwijaya, Bambang; Czibere, Akos; Naumann, R. Wendel; Coleman, Robert L.; Vergote, Ignace; MacBeath, Gavin; Pujade-Lauraine, Eric

2016-01-01

Purpose Seribantumab is a fully human immunoglobulin G2 monoclonal antibody that binds to human epidermal growth factor receptor (HER) 3 (ErbB3), blocking heregulin (HRG) –mediated ErbB3 signaling and inducing ErbB3 receptor downregulation. This open-label randomized phase II study evaluated progression-free survival (PFS) with seribantumab in combination with once-per-week paclitaxel compared with paclitaxel alone in patients with platinum-resistant or -refractory ovarian cancer. A key secondary objective was to determine if any of five prespecified biomarkers predicted benefit from seribantumab. Patients and Methods Patients with platinum-resistant or -refractory epithelial ovarian, fallopian tube, or primary peritoneal cancer were randomly assigned at a ratio of two to one to receive seribantumab plus paclitaxel or paclitaxel alone. Patients underwent pretreatment core needle biopsy; archival tumor samples were also obtained to support biomarker analyses. Results A total of 223 patients were randomly assigned (seribantumab plus paclitaxel, n = 140; paclitaxel alone, n = 83). Median PFS in the unselected intent-to-treat population was 3.75 months with seribantumab plus paclitaxel compared with 3.68 months with paclitaxel alone (hazard ratio [HR], 1.027; 95% CI, 0.741 to 1.425; P = .864). Among patients whose tumors had detectable HRG mRNA and low HER2 (n = 57 [38%] of 151 with available biomarker data), increased treatment benefit was observed in those receiving seribantumab plus paclitaxel compared with paclitaxel alone (PFS HR, 0.37; 95% CI, 0.18 to 0.76; P = .007). The HR in patients not meeting these criteria was 1.80 (95% CI, 1.08 to 2.98; P = .023). Conclusion The addition of seribantumab to paclitaxel did not result in improved PFS in unselected patients. Exploratory analyses suggest that detectable HRG and low HER2, biomarkers that link directly to the mechanism of action of seribantumab, identified patients who might benefit from this combination. Future clinical trials are needed to validate this finding and should preselect for HRG expression and focus on cancers with low HER2 levels. PMID:27998236

Randomized Phase II Trial of Seribantumab in Combination With Paclitaxel in Patients With Advanced Platinum-Resistant or -Refractory Ovarian Cancer.

PubMed

Liu, Joyce F; Ray-Coquard, Isabelle; Selle, Frederic; Poveda, Andrés M; Cibula, David; Hirte, Hal; Hilpert, Felix; Raspagliesi, Francesco; Gladieff, Laurence; Harter, Philipp; Siena, Salvatore; Del Campo, Josep Maria; Tabah-Fisch, Isabelle; Pearlberg, Joseph; Moyo, Victor; Riahi, Kaveh; Nering, Rachel; Kubasek, William; Adiwijaya, Bambang; Czibere, Akos; Naumann, R Wendel; Coleman, Robert L; Vergote, Ignace; MacBeath, Gavin; Pujade-Lauraine, Eric

2016-12-20

Purpose Seribantumab is a fully human immunoglobulin G2 monoclonal antibody that binds to human epidermal growth factor receptor (HER) 3 (ErbB3), blocking heregulin (HRG) -mediated ErbB3 signaling and inducing ErbB3 receptor downregulation. This open-label randomized phase II study evaluated progression-free survival (PFS) with seribantumab in combination with once-per-week paclitaxel compared with paclitaxel alone in patients with platinum-resistant or -refractory ovarian cancer. A key secondary objective was to determine if any of five prespecified biomarkers predicted benefit from seribantumab. Patients and Methods Patients with platinum-resistant or -refractory epithelial ovarian, fallopian tube, or primary peritoneal cancer were randomly assigned at a ratio of two to one to receive seribantumab plus paclitaxel or paclitaxel alone. Patients underwent pretreatment core needle biopsy; archival tumor samples were also obtained to support biomarker analyses. Results A total of 223 patients were randomly assigned (seribantumab plus paclitaxel, n = 140; paclitaxel alone, n = 83). Median PFS in the unselected intent-to-treat population was 3.75 months with seribantumab plus paclitaxel compared with 3.68 months with paclitaxel alone (hazard ratio [HR], 1.027; 95% CI, 0.741 to 1.425; P = .864). Among patients whose tumors had detectable HRG mRNA and low HER2 (n = 57 [38%] of 151 with available biomarker data), increased treatment benefit was observed in those receiving seribantumab plus paclitaxel compared with paclitaxel alone (PFS HR, 0.37; 95% CI, 0.18 to 0.76; P = .007). The HR in patients not meeting these criteria was 1.80 (95% CI, 1.08 to 2.98; P = .023). Conclusion The addition of seribantumab to paclitaxel did not result in improved PFS in unselected patients. Exploratory analyses suggest that detectable HRG and low HER2, biomarkers that link directly to the mechanism of action of seribantumab, identified patients who might benefit from this combination. Future clinical trials are needed to validate this finding and should preselect for HRG expression and focus on cancers with low HER2 levels.

Ibrutinib as Treatment for Patients With Relapsed/Refractory Follicular Lymphoma: Results From the Open-Label, Multicenter, Phase II DAWN Study.

PubMed

Gopal, Ajay K; Schuster, Stephen J; Fowler, Nathan H; Trotman, Judith; Hess, Georg; Hou, Jing-Zhou; Yacoub, Abdulraheem; Lill, Michael; Martin, Peter; Vitolo, Umberto; Spencer, Andrew; Radford, John; Jurczak, Wojciech; Morton, James; Caballero, Dolores; Deshpande, Sanjay; Gartenberg, Gary J; Wang, Shean-Sheng; Damle, Rajendra N; Schaffer, Michael; Balasubramanian, Sriram; Vermeulen, Jessica; Cheson, Bruce D; Salles, Gilles

2018-05-31

Purpose The Bruton's tyrosine kinase inhibitor ibrutinib has demonstrated clinical activity in B-cell malignancies. The DAWN study assessed the efficacy and safety of single-agent ibrutinib in chemoimmunotherapy relapsed/refractory follicular lymphoma (FL) patients. Methods DAWN was an open-label, single-arm, phase II study of ibrutinib in patients with FL with two or more prior lines of therapy. Patients received ibrutinib 560 mg daily until progressive disease/unacceptable toxicity. The primary objective was independent review committee-assessed overall response rate (ORR; complete response plus partial response). Exploratory analyses of T-cell subsets in peripheral blood (baseline/cycle 3) and cytokines/chemokines (baseline/cycle 2) were performed for available samples. Results Between March 2013 and May 2016, 110 patients with a median of three prior lines of therapy were enrolled. At median follow-up of 27.7 months, ORR was 20.9% (95% CI, 13.7% to 29.7%, which did not meet the 18% lower-bound threshold for the primary end point). Twelve patients achieved a complete response (11%; 95% CI, 5.8% to 18.3%). Median duration of response was 19.4 months (range, 1 to ≥ 33 months), with a median progression-free survival of 4.6 months and a 30-month overall survival of 61% (95% CI, 0.51% to 0.70%). Lymphoma symptoms resolved in 67%. Seven of 32 patients who experienced initial radiologic progression responded upon continuing therapy (pseudoprogression). The most common adverse events were diarrhea, fatigue, cough, and muscle spasms; 48.2% of patients reported serious adverse events. In patients who experienced a response, regulatory T cells were downregulated at C3D1 ( P = .02), and Th1-promoting (antitumor) cytokines interferon-γ and interleukin-12 increased ( P ≤ .035). Conclusion With an ORR of 20.9%, ibrutinib failed to meet its primary efficacy end point in chemoimmunotherapy in patients with relapsed/refractory FL, although responses were durable and associated with a reduction in regulatory T cells and increases in proinflammatory cytokines.

Phase II study of metformin for reduction of obesity-associated breast cancer risk: a randomized controlled trial protocol.

PubMed

Martinez, Jessica A; Chalasani, Pavani; Thomson, Cynthia A; Roe, Denise; Altbach, Maria; Galons, Jean-Philippe; Stopeck, Alison; Thompson, Patricia A; Villa-Guillen, Diana Evelyn; Chow, H-H Sherry

2016-07-19

Two-thirds of U.S. adult women are overweight or obese. High body mass index (BMI) and adult weight gain are risk factors for a number of chronic diseases, including postmenopausal breast cancer. The higher postmenopausal breast cancer risk in women with elevated BMI is likely to be attributable to related metabolic disturbances including altered circulating sex steroid hormones and adipokines, elevated pro-inflammatory cytokines, and insulin resistance. Metformin is a widely used antidiabetic drug that has demonstrated favorable effects on metabolic disturbances and as such may lead to lower breast cancer risk in obese women. Further, the anti-proliferative effects of metformin suggest it may decrease breast density, an accepted biomarker of breast cancer risk. This is a Phase II randomized, double-blind, placebo-controlled trial of metformin in overweight/obese premenopausal women who have elements of metabolic syndrome. Eligible participants will be randomized to receive metformin 850 mg BID (n = 75) or placebo (n = 75) for 12 months. The primary endpoint is change in breast density, based on magnetic resonance imaging (MRI) acquired fat-water features. Secondary outcomes include changes in serum insulin levels, serum insulin-like growth factor (IGF)-1 to insulin-like growth factor binding protein (IGFBP)-3 ratio, serum IGF-2 levels, serum testosterone levels, serum leptin to adiponectin ratio, body weight, and waist circumference. Exploratory outcomes include changes in metabolomic profiles in plasma and nipple aspirate fluid. Changes in tissue architecture as well as cellular and molecular targets in breast tissue collected in a subgroup of participants will also be explored. The study will evaluate whether metformin can result in favorable changes in breast density, select proteins and hormones, products of body metabolism, and body weight and composition. The study should help determine the potential breast cancer preventive activity of metformin in a growing population at risk for multiple diseases. ClinicalTrials.gov Identifier: NCT02028221 . Registered on January 2, 2014. Grant #: 1R01CA172444-01A1 awarded on Sept 11, 2013.

Phase II randomized study of PM01183 versus topotecan in patients with platinum-resistant/refractory advanced ovarian cancer

PubMed Central

Poveda, A.; del Campo, J. M.; Ray-Coquard, I.; Alexandre, J.; Provansal, M.; Guerra Alía, E. M.; Casado, A.; Gonzalez-Martin, A.; Fernández, C.; Rodriguez, I.; Soto, A.; Kahatt, C.; Fernández Teruel, C.; Galmarini, C. M.; Pérez de la Haza, A.; Bohan, P.; Berton-Rigaud, D.

2017-01-01

Background PM01183 is a new compound that blocks active transcription, produces DNA breaks and apoptosis, and affects the inflammatory microenvironment. PM01183 showed strong antitumor activity in preclinical models of cisplatin-resistant epithelial ovarian cancer. Patients and methods Patients with platinum-resistant/refractory ovarian cancer were included in a two-stage, controlled, randomized (in a second stage), multicenter, phase II study. Primary endpoint was overall response rate (ORR) by RECIST and/or GCIG criteria. The exploratory first stage (n = 22) confirmed the activity of PM01183 as a single agent at 7.0 mg flat dose every 3 weeks (q3wk). The second stage (n = 59) was randomized and controlled with topotecan on days 1–5 q3wk or weekly (every 4 weeks, q4wk). Results ORR was 23% (95% CI, 13%–37%) for 52 PM01183-treated patients. Median duration of response was 4.6 months (95% CI, 2.5–6.9 months), and 23% (95% CI, 0%–51%) of responses lasted 6 months or more. Ten of the 12 confirmed responses were reported for 33 patients with platinum-resistant disease [ORR = 30% (95% CI, 16%–49%)]; for the 29 patients treated with topotecan in the second stage, no responses were found. Median PFS for all PM01183-treated patients was 4.0 months (95% CI, 2.7–5.6 months), and 5.0 months (95% CI, 2.7–6.9 months) for patients with platinum-resistant disease. Grade 3/4 neutropenia in 85% of patients; febrile neutropenia in 21% and fatigue (grade 3 in 35%) were the principal safety findings for PM01183. Conclusion PM01183 is an active drug in platinum-resistant/refractory ovarian cancer and warrants further development. The highest activity was observed in platinum-resistant disease. Its safety profile indicates the dose should be adjusted to body surface area (mg/m2). Trial code EudraCT 2011-002172-16. PMID:28368437

Phase II randomized study of PM01183 versus topotecan in patients with platinum-resistant/refractory advanced ovarian cancer.

PubMed

Poveda, A; Del Campo, J M; Ray-Coquard, I; Alexandre, J; Provansal, M; Guerra Alía, E M; Casado, A; Gonzalez-Martin, A; Fernández, C; Rodriguez, I; Soto, A; Kahatt, C; Fernández Teruel, C; Galmarini, C M; Pérez de la Haza, A; Bohan, P; Berton-Rigaud, D

2017-06-01

PM01183 is a new compound that blocks active transcription, produces DNA breaks and apoptosis, and affects the inflammatory microenvironment. PM01183 showed strong antitumor activity in preclinical models of cisplatin-resistant epithelial ovarian cancer. Patients with platinum-resistant/refractory ovarian cancer were included in a two-stage, controlled, randomized (in a second stage), multicenter, phase II study. Primary endpoint was overall response rate (ORR) by RECIST and/or GCIG criteria. The exploratory first stage (n = 22) confirmed the activity of PM01183 as a single agent at 7.0 mg flat dose every 3 weeks (q3wk). The second stage (n = 59) was randomized and controlled with topotecan on days 1-5 q3wk or weekly (every 4 weeks, q4wk). ORR was 23% (95% CI, 13%-37%) for 52 PM01183-treated patients. Median duration of response was 4.6 months (95% CI, 2.5-6.9 months), and 23% (95% CI, 0%-51%) of responses lasted 6 months or more. Ten of the 12 confirmed responses were reported for 33 patients with platinum-resistant disease [ORR = 30% (95% CI, 16%-49%)]; for the 29 patients treated with topotecan in the second stage, no responses were found. Median PFS for all PM01183-treated patients was 4.0 months (95% CI, 2.7-5.6 months), and 5.0 months (95% CI, 2.7-6.9 months) for patients with platinum-resistant disease. Grade 3/4 neutropenia in 85% of patients; febrile neutropenia in 21% and fatigue (grade 3 in 35%) were the principal safety findings for PM01183. PM01183 is an active drug in platinum-resistant/refractory ovarian cancer and warrants further development. The highest activity was observed in platinum-resistant disease. Its safety profile indicates the dose should be adjusted to body surface area (mg/m2). EudraCT 2011-002172-16. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Nursing diagnosis in older adults with chronic kidney disease on hemodialysis.

PubMed

Debone, Mayara Cristina; Pedruncci, Elisângela da Silva Nunes; Candido, Maristela do Carmo Peterossi; Marques, Sueli; Kusumota, Luciana

2017-01-01

To identify the main nursing diagnoses (NSs) in older adult patients under hemodialysis treatment. Exploratory research using case studies in data collection performed by interview and physical examination of older adults, in the first semester of 2016. Were included twenty-eight older adults undergoing chronic hemodialysis treatment who met the selection criteria. The analysis followed two steps (RISNER, 1990): Phase I - Data analysis and synthesis; and Phase II - Establishment of nursing diagnoses using the taxonomy of NANDA-I (2015). The total of NSs was 110, averaging 3.9 per patient. It was listed seven different NSs, and both the Risk of infection and the Volume of excessive liquids appeared on all patients (28; 100%), and risk of electrolyte imbalance, in 26 (96.8%) older adults, being considered as main NSs. Such results can help systematize the care of older people who are undergoing hemodialysis treatment. Identificar os principais diagnósticos de enfermagem (DEs) em pacientes idosos em tratamento hemodialítico. Pesquisa exploratória utilizando estudos de casos na coleta de dados realizada por entrevista e exame físico dos idosos, no primeiro semestre de 2016. Foram incluídos 28 idosos em tratamento crônico por hemodiálise que atenderam aos critérios de seleção. A análise seguiu duas etapas (RISNER, 1990): Fase I - Análise e síntese dos dados; e Fase II - Estabelecimento dos diagnósticos de enfermagem utilizando a taxonomia da NANDA-I (2015). O total de DEs foi de 110, com média de 3,9 por paciente. Foram elencados sete DEs diferentes, sendo que tanto o Risco de infecção quanto o Volume de líquidos excessivo apareceram em todos os pacientes (28; 100%), e Risco de desequilíbrio eletrolítico, em 26 (96,8%) idosos, sendo considerados como principais DEs. Tais resultados podem colaborar na sistematização da assistência do idoso em tratamento hemodialítico.

Pemetrexed-Erlotinib, Pemetrexed Alone, or Erlotinib Alone as Second-Line Treatment for East Asian and Non-East Asian Never-Smokers with Locally Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer: Exploratory Subgroup Analysis of a Phase II Trial

PubMed Central

Lee, Dae Ho; Lee, Jung Shin; Wang, Jie; Hsia, Te-Chun; Wang, Xin; Kim, Jongseok; Orlando, Mauro

2015-01-01

Purpose This subgroup analysis of a phase II trial was conducted to assess possible ethnicity-based trends in efficacy and safety in East Asian (EA) and non-EA populations with nonsquamous non-small cell lung cancer (NSCLC). Materials and Methods Never-smoker patients (n=240) with locally advanced or metastatic nonsquamous NSCLC included 133 EA patients randomized to pemetrexed supplemented with dexamethasone, folic acid, and vitamin B12 plus erlotinib (pemetrexed-erlotinib) (n=41), erlotinib (n=49), or pemetrexed (n=43), and 107 non-EA patients randomized to pemetrexed-erlotinib (n=37), erlotinib (n=33), or pemetrexed (n=37). The primary endpoint, progression-free survival (PFS), was analyzed using a multivariate Cox model. Results Consistent with the results of the overall study, a statistically significant difference in PFS among the three arms was noted in the EA population favoring pemetrexed-erlotinib (overall p=0.003) as compared with either single-agent arm (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.29 to 0.79; p=0.004 vs. erlotinib; HR, 0.40; 95% CI, 0.23 to 0.70; p=0.001 vs. pemetrexed). The EA patients treated with pemetrexed-erlotinib achieved a longer median PFS (7.4 months) compared with erlotinib (4.5 months) and pemetrexed (4.0 months). The PFS results also numerically favored pemetrexed-erlotinib in the non-EA population (overall p=0.210) (HR, 0.62; 95% CI, 0.37 to 1.05; p=0.078 vs. erlotinib; HR, 0.75; 95% CI, 0.42 to 1.32; p=0.320 vs. pemetrexed) (median PFS: pemetrexed-erlotinib, 6.7 months; erlotinib, 3.0 months; pemetrexed, 4.4 months). Conclusion The PFS results from this subset analysis in both EA and non-EA populations are consistent with the results in the overall population. The PFS advantage for pemetrexed-erlotinib is significant compared with the single agents in EA patients. PMID:25672577

mFOLFOX6 Plus Panitumumab Versus 5-FU/LV Plus Panitumumab After Six Cycles of Frontline mFOLFOX6 Plus Panitumumab: A Randomized Phase II Study of Patients With Unresectable or Advanced/Recurrent, RAS Wild-type Colorectal Carcinoma (SAPPHIRE)-Study Design and Rationale.

PubMed

Nagata, Naoki; Mishima, Hideyuki; Kurosawa, Shuichi; Oba, Koji; Sakamoto, Junichi

2017-06-01

In Japan, oxaliplatin (OXA)/5-fluorouracil (5-FU)/leucovorin (LV)-the mFOLFOX6 regimen-is the most frequently used first-line chemotherapy backbone for metastatic colorectal cancer. However, peripheral nerve disorders caused by OXA during mFOLFOX6 therapy can decrease patients' quality of life. OXA can be safely discontinued from a FOLFOX regimen after 6 cycles during first-line therapy. Also, for patients who discontinue OXA without having experienced peripheral nerve disorders, reintroducing OXA in the later stages of treatment could remain an option. The study is a phase II, multicenter, open-label, parallel-group, randomized, controlled exploratory study comparing the efficacy and safety of mFOLFOX6 plus panitumumab and 5-FU/LV plus panitumumab in patients with chemotherapy-naïve, unresectable, advanced or recurrent colorectal carcinoma of RAS wild-type (SAPPHIRE; ClinicalTrials.gov identifier, NCT02337946). Eligible patients will receive 6 cycles of mFOLFOX6 plus panitumumab combination therapy, followed by 1:1 randomization to either further treatment with mFOLFOX6 plus panitumumab or discontinuation of OXA and treatment with 5-FU/LV plus panitumumab. Up to 100 randomized patients will receive treatment for approximately 12 months or until any of the criteria for treatment discontinuation have been met. The primary endpoint is progression-free survival rate at 9 months after the day of randomization. The secondary endpoints are progression-free survival, overall survival, response rate, and interval to treatment failure. Safety will be evaluated according to the incidence and severity of adverse events, including the incidence of peripheral nerve and skin disorders. Additional endpoints will include maintenance of performance status, continuation of OXA in the mFOLFOX6 plus panitumumab group, and continuation of panitumumab in both groups. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Phase II randomized trial of radiation therapy, cetuximab, and pemetrexed with or without bevacizumab in patients with locally advanced head and neck cancer.

PubMed

Argiris, A; Bauman, J E; Ohr, J; Gooding, W E; Heron, D E; Duvvuri, U; Kubicek, G J; Posluszny, D M; Vassilakopoulou, M; Kim, S; Grandis, J R; Johnson, J T; Gibson, M K; Clump, D A; Flaherty, J T; Chiosea, S I; Branstetter, B; Ferris, R L

2016-08-01

We previously reported the safety of concurrent cetuximab, an antibody against epidermal growth factor receptor (EGFR), pemetrexed, and radiation therapy (RT) in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). In this non-comparative phase II randomized trial, we evaluated this non-platinum combination with or without bevacizumab, an inhibitor of vascular endothelial growth factor (VEGF). Patients with previously untreated stage III-IVB SCCHN were randomized to receive: conventionally fractionated radiation (70 Gy), concurrent cetuximab, and concurrent pemetrexed (arm A); or the identical regimen plus concurrent bevacizumab followed by bevacizumab maintenance for 24 weeks (arm B). The primary end point was 2-year progression-free survival (PFS), with each arm compared with historical control. Exploratory analyses included the relationship of established prognostic factors to PFS and quality of life (QoL). Seventy-eight patients were randomized: 66 oropharynx (42 HPV-positive, 15 HPV-negative, 9 unknown) and 12 larynx; 38 (49%) had heavy tobacco exposure. Two-year PFS was 79% [90% confidence interval (CI) 0.69-0.92; P < 0.0001] for arm A and 75% (90% CI 0.64-0.88; P < 0.0001) for arm B, both higher than historical control. No differences in PFS were observed for stage, tobacco history, HPV status, or type of center (community versus academic). A significantly increased rate of hemorrhage occurred in arm B. SCCHN-specific QoL declined acutely, with marked improvement but residual symptom burden 1 year post-treatment. RT with a concurrent non-platinum regimen of cetuximab and pemetrexed is feasible in academic and community settings, demonstrating expected toxicities and promising efficacy. Adding bevacizumab increased toxicity without apparent improvement in efficacy, countering the hypothesis that dual EGFR-VEGF targeting would overcome radiation resistance, and enhance clinical benefit. Further development of cetuximab, pemetrexed, and RT will require additional prospective study in defined, high-risk populations where treatment intensification is justified. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Liquid Phase Deposition of Single-Phase Alpha-Copper-Indium-Diselenide

NASA Technical Reports Server (NTRS)

Hepp, Aloysius F.; Bailey, S.; Cowen, Jonathan; Lucas, L.; Ernst, Frank; Pirouz, P.

2004-01-01

The success of exploratory missions in outer space often depends on a highly efficient renewable energy supply, as provided by solar cells. Since future missions will demand large aggregates of solar cells, and space flight is expensive, the solar cells must furthermore be available at low costs and have a long lifetime and high resistance against structural damage introduced by irradiation with high energy electrons and protons. The photovoltaic materials that are presently available only partly fulfill all these requirements. Therefore, we propose to explore a new method for fabricating thin-films for cost-efficient solar cells with very high specific power,high irradiation resistance and long lifetime based on the alpha-phase of the Cu-In-Se system "alpha-CIS."

Dental and skeletal changes in patients with mandibular retrognathism following treatment with Herbst and pre-adjusted fixed appliance

PubMed Central

Vigorito, Fabio de Abreu; Dominguez, Gladys Cristina; Aidar, Luís Antônio de Arruda

2014-01-01

Objective To assess the dentoskeletal changes observed in treatment of Class II, division 1 malocclusion patients with mandibular retrognathism. Treatment was performed with the Herbst orthopedic appliance during 13 months (phase I) and pre-adjusted orthodontic fixed appliance (phase II). Methods Lateral cephalograms of 17 adolescents were taken in phase I onset (T1) and completion (T2); in the first thirteen months of phase II (T3) and in phase II completion (T4). Differences among the cephalometric variables were statistically analyzed (Bonferroni variance and multiple comparisons). Results From T1 to T4, 42% of overall maxillary growth was observed between T1 and T2 (P < 0.01), 40.3% between T2 and T3 (P < 0.05) and 17.7% between T3 and T4 (n.s.). As for overall mandibular movement, 48.2% was observed between T1 and T2 (P < 0.001) and 51.8% between T2 and T4 (P < 0.01) of which 15.1% was observed between T2 and T3 (n.s.) and 36.7% between T3 and T4 (P < 0.01). Class II molar relationship and overjet were properly corrected. The occlusal plane which rotated clockwise between T1 and T2, returned to its initial position between T2 and T3 remaining stable until T4. The mandibular plane inclination did not change at any time during treatment. Conclusion Mandibular growth was significantly greater in comparison to maxillary, allowing sagittal maxillomandibular adjustment. The dentoalveolar changes (upper molar) that overcorrected the malocclusion in phase I, partially recurred in phase II, but did not hinder correction of the malocclusion. Facial type was preserved. PMID:24713559

Preconcentration of trace lead and iron on activated carbon functionalized by o-Anisic acid derivatives prior to their determination in environmental samples.

PubMed

Tian, Hua; Hu, Zheng; He, Qun; Liu, Xueliang; Zhang, Li; Chang, Xijun

2012-07-01

Two solid-phase adsorbents (phase I and phase II) were synthesized successfully that o-Anisic acid derivatives were evenly functionalized on the surface of activated carbon. It was certified that the two adsorbents were applied to preconcentrate and separate trace levels of Pb(II) and Fe(III) from natural liquid samples with satisfactory results. It can be found that the adsorption capacity of the ions adsorbed on phase I and phase II was 48.3 and 85.7 mg g(-1) for Pb(II), 39.5 and 72.5 mg g(-1) for Fe(III), respectively. The detection limit (3σ) of the method separated on phase I and phase II was 0.12 and 0.09 ng mL(-1) for Pb(II), 0.23 and 0.17 ng mL(-1) for Fe(III), respectively. The relative standard deviation (R.S.D.) of the method was lower than 3.0%. The adsorption and desorption property of two kinds of adsorbents was comparatively studied, respectively. The adsorption selectivity of heavy metal ions at certain pH, the adsorption kinetics, the condition of complete elution, the effect of coexisting ions, the adsorption capacity and adsorption isotherm modes were examined. Based on the experimental datum determined by inductively coupled plasma optical emission spectrometry (ICP-OES), it was certified that the adsorption on the surface of adsorbents was in strict accordance with the monolayer adsorption principle. The structural features of series of multidentate ligand modified on adsorption matrix had been obtained. These conclusions can provide reference for synthesizing an efficient adsorbent which is specific to remove a particular kind of contaminant. Copyright © 2012 Elsevier B.V. All rights reserved.

Research safety vehicle program (Phase II) specification review. Volume II. Final technical report, Jul 1975--Nov 1976

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pugliese, S.M.

1977-02-01

In Phase I of the Research Safety Vehicle Program (RSV), preliminary design and performance specifications were developed for a mid-1980's vehicle that integrates crashworthiness and occupant safety features with material resource conservation, economy, and producibility. Phase II of the program focused on development of the total vehicle design via systems engineering and integration analyses. As part of this effort, it was necessary to continuously review the Phase I recommended performance specification in relation to ongoing design/test activities. This document contains the results of analyses of the Phase I specifications. The RSV is expected to satisfy all of the producibility andmore » safety related specifications, i.e., handling and stability systems, crashworthiness, occupant protection, pedestrian/cyclist protection, etc.« less

Validation of the phase II feasibility study in a palliative care setting: gastrografin in malignant bowel obstruction.

PubMed

Lee, Cindy; Vather, Ryash; O'Callaghan, Anne; Robinson, Jackie; McLeod, Briar; Findlay, Michael; Bissett, Ian

2013-12-01

Malignant bowel obstruction (MBO) is common in patients with advanced cancer. To perform a phase II study to assess the feasibility of conducting a phase III trial investigating the therapeutic value of gastrografin in MBO. Randomized double-blinded placebo-controlled feasibility study. Participants received 100 mL of either gastrografin or placebo. Over 8 months, 57 patients were screened and 9 enrolled (15.8% recruitment rate). Of the 9 enrolled, 4 received gastrografin (with 2 completing assessment) and 5 received placebo (with 4 completing assessment). It is not feasible to conduct a phase III trial using the same study protocol. This study validates the use of the phase II feasibility study to assess protocol viability in a palliative population prior to embarking on a larger trial.

Chronic Iron Limitation Confers Transient Resistance to Oxidative Stress in Marine Diatoms.

PubMed

Graff van Creveld, Shiri; Rosenwasser, Shilo; Levin, Yishai; Vardi, Assaf

2016-10-01

Diatoms are single-celled, photosynthetic, bloom-forming algae that are responsible for at least 20% of global primary production. Nevertheless, more than 30% of the oceans are considered "ocean deserts" due to iron limitation. We used the diatom Phaeodactylum tricornutum as a model system to explore diatom's response to iron limitation and its interplay with susceptibility to oxidative stress. By analyzing physiological parameters and proteome profiling, we defined two distinct phases: short-term (<3 d, phase I) and chronic (>5 d, phase II) iron limitation. While at phase I no significant changes in physiological parameters were observed, molecular markers for iron starvation, such as Iron Starvation Induced Protein and flavodoxin, were highly up-regulated. At phase II, down-regulation of numerous iron-containing proteins was detected in parallel to reduction in growth rate, chlorophyll content, photosynthetic activity, respiration rate, and antioxidant capacity. Intriguingly, while application of oxidative stress to phase I and II iron-limited cells similarly oxidized the reduced glutathione (GSH) pool, phase II iron limitation exhibited transient resistance to oxidative stress, despite the down regulation of many antioxidant proteins. By comparing proteomic profiles of P. tricornutum under iron limitation and metatranscriptomic data of an iron enrichment experiment conducted in the Pacific Ocean, we propose that iron-limited cells in the natural environment resemble the phase II metabolic state. These results provide insights into the trade-off between optimal growth rate and susceptibility to oxidative stress in the response of diatoms to iron quota in the marine environment. © 2016 American Society of Plant Biologists. All Rights Reserved.

Evaluation of phase II toxicity identification evaluation methods for freshwater whole sediment and interstitial water.

PubMed

Phillips, Bryn M; Anderson, Brian S; Hunt, John W; Clark, Sara L; Voorhees, Jennifer P; Tjeerdema, Ron S; Casteline, Jane; Stewart, Margaret

2009-02-01

Phase I whole sediment toxicity identification evaluation (TIE) methods have been developed to characterize the cause of toxicity as organic chemicals, metals, or ammonia. In Phase II identification treatments, resins added to whole sediment to reduce toxicity caused by metals and organics can be separated and eluted much like solid-phase extraction (SPE) columns are eluted for interstitial water. In this study, formulated reference sediments spiked with toxic concentrations of copper, fluoranthene, and nonylphenol were subjected to whole sediment and interstitial water TIE treatments to evaluate Phase I and II TIE procedures for identifying the cause of toxicity to Hyalella azteca. Phase I TIE treatments consisted of adding adsorbent resins to whole sediment, and using SPE columns to remove spiked chemicals from interstitial water. Phase II treatments consisted of eluting resins and SPE columns and the preparation and testing of eluates for toxicity and chemistry. Whole sediment resins and SPE columns significantly reduced toxicity, and the eluates from all treatments contained toxic concentrations of the spiked chemical except for interstitial water fluoranthene. Toxic unit analysis based on median lethal concentrations (LC50s) allowed for the comparison of chemical concentrations among treatments, and demonstrated that the bioavailability of some chemicals was reduced in some samples and treatments. The concentration of fluoranthene in the resin eluate closely approximated the original interstitial water concentration, but the resin eluate concentrations of copper and nonylphenol were much higher than the original interstitial water concentrations. Phase II whole sediment TIE treatments provided complementary lines of evidence to the interstitial water TIE results.

Chronic Iron Limitation Confers Transient Resistance to Oxidative Stress in Marine Diatoms1

PubMed Central

Graff van Creveld, Shiri; Rosenwasser, Shilo; Vardi, Assaf

2016-01-01

Diatoms are single-celled, photosynthetic, bloom-forming algae that are responsible for at least 20% of global primary production. Nevertheless, more than 30% of the oceans are considered “ocean deserts” due to iron limitation. We used the diatom Phaeodactylum tricornutum as a model system to explore diatom’s response to iron limitation and its interplay with susceptibility to oxidative stress. By analyzing physiological parameters and proteome profiling, we defined two distinct phases: short-term (<3 d, phase I) and chronic (>5 d, phase II) iron limitation. While at phase I no significant changes in physiological parameters were observed, molecular markers for iron starvation, such as Iron Starvation Induced Protein and flavodoxin, were highly up-regulated. At phase II, down-regulation of numerous iron-containing proteins was detected in parallel to reduction in growth rate, chlorophyll content, photosynthetic activity, respiration rate, and antioxidant capacity. Intriguingly, while application of oxidative stress to phase I and II iron-limited cells similarly oxidized the reduced glutathione (GSH) pool, phase II iron limitation exhibited transient resistance to oxidative stress, despite the down regulation of many antioxidant proteins. By comparing proteomic profiles of P. tricornutum under iron limitation and metatranscriptomic data of an iron enrichment experiment conducted in the Pacific Ocean, we propose that iron-limited cells in the natural environment resemble the phase II metabolic state. These results provide insights into the trade-off between optimal growth rate and susceptibility to oxidative stress in the response of diatoms to iron quota in the marine environment. PMID:27503604

SH-2F LAMPS Instructional Systems Development: Phase II. Final Report.

ERIC Educational Resources Information Center

Gibbons, Andrew S.; Hymes, Jonah P.

This project was one of four aircrew training development projects in a continuing study of the methodology, effectiveness, and resource requirements of the Instructional Systems Development (ISD) process. This report covers the Phase II activities of a two-phase project for the development of aircrew training for SH-2F anti-submarine warfare…

40 CFR 63.163 - Standards: Pumps in light liquid service.

Code of Federal Regulations, 2013 CFR

2013-07-01

... later than 1 year after the compliance date; and (C) Phase III, beginning no later than 21/2 years after... requirements; and (B) Beginning no later than 1 year after initial start-up, comply with the Phase III... parts per million or greater. (ii) For Phase II, an instrument reading of 5,000 parts per million or...

40 CFR 63.163 - Standards: Pumps in light liquid service.

Code of Federal Regulations, 2012 CFR

2012-07-01

... later than 1 year after the compliance date; and (C) Phase III, beginning no later than 21/2 years after... requirements; and (B) Beginning no later than 1 year after initial start-up, comply with the Phase III... parts per million or greater. (ii) For Phase II, an instrument reading of 5,000 parts per million or...

40 CFR 63.163 - Standards: Pumps in light liquid service.

Code of Federal Regulations, 2014 CFR

2014-07-01

... later than 1 year after the compliance date; and (C) Phase III, beginning no later than 21/2 years after... requirements; and (B) Beginning no later than 1 year after initial start-up, comply with the Phase III... parts per million or greater. (ii) For Phase II, an instrument reading of 5,000 parts per million or...

An Experimental Evaluation of Hyperactivity and Food Additives. 1977-Phase II.

ERIC Educational Resources Information Center

Harley, J. Preston; And Others

Phase II of a study on the effectiveness of B. Feingold's recommended diet for hyperactive children involved the nine children (mean age 9 years) who had shown the "best" response to diet manipulation in Phase I. Each child served as his own control and was challenged with specified amounts of placebo and artificial color containing food…

Job Aids: Descriptive Authoring Flowcharts for Phase II--DESIGN of the Instructional Systems Development Model.

ERIC Educational Resources Information Center

Schulz, Russel E.; Farrell, Jean R.

This resource guide for the use of job aids ("how-to-do-it" guidance) for activities identified in the second phase of the Instructional Systems Development Model (ISD) contains an introduction to the use of job aids, as well as descriptive authoring flowcharts for Blocks II.1 through II.4. The introduction includes definitions;…

Thermal, spectroscopic and structural characterization of isostructural phase transition in 4-hydroxybenzaldehyde

NASA Astrophysics Data System (ADS)

Panicker, Lata

2018-05-01

Polycrystalline samples of 4-hydroxybenzaldehyde (4-HOBAL) were investigated using differential scanning calorimeter (DSC), Raman spectroscopy and X-ray powder diffraction. The DSC data indicated that 4-HOBAL on heating undergoes a polymorphic transformation from polymorph I to polymorph II. The polymorph II formed remains metastable at ambient condition and transforms to polymorph I when annealed at ambient temperature for more than seven days. The structural information of polymorphs I and II obtained using its X-ray powder diffraction patterns indicated that 4-HOBAL undergoes an isostructural phase transition from polymorph I (monoclinic, P21/c) to polymorph II (monoclinic, P21/c). Raman data suggest that this structural change is associated with some change in its molecular interactions. Thus, in 4-HOBAL the polymorphic phase transformation (II to I) even though energetically favoured is kinetically hindered.

Phase I/II Study of Erlotinib Combined With Cisplatin and Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

DOE Office of Scientific and Technical Information (OSTI.GOV)

Herchenhorn, Daniel, E-mail: herchenhorn@hotmail.co; Dias, Fernando L.; Viegas, Celia M.P.

Purpose: Erlotinib, an oral tyrosine kinase inhibitor, is active against head-and-neck squamous cell carcinoma (HNSCC) and possibly has a synergistic interaction with chemotherapy and radiotherapy. We investigated the safety and efficacy of erlotinib added to cisplatin and radiotherapy in locally advanced HNSCC. Methods and Materials: In this Phase I/II trial 100 mg/m{sup 2} of cisplatin was administered on Days 8, 29, and 50, and radiotherapy at 70 Gy was started on Day 8. During Phase I, the erlotinib dose was escalated (50 mg, 100 mg, and 150 mg) in consecutive cohorts of 3 patients, starting on Day 1 and continuingmore » during radiotherapy. Dose-limiting toxicity was defined as any Grade 4 event requiring radiotherapy interruptions. Phase II was initiated 8 weeks after the last Phase I enrollment. Results: The study accrued 9 patients in Phase I and 28 in Phase II; all were evaluable for efficacy and safety. No dose-limiting toxicity occurred in Phase I, and the recommended Phase II dose was 150 mg. The most frequent nonhematologic toxicities were nausea/vomiting, dysphagia, stomatitis, xerostomia and in-field dermatitis, acneiform rash, and diarrhea. Of the 31 patients receiving a 150-mg daily dose of erlotinib, 23 (74%; 95% confidence interval, 56.8%-86.3%) had a complete response, 3 were disease free after salvage surgery, 4 had inoperable residual disease, and 1 died of sepsis during treatment. With a median 37 months' follow-up, the 3-year progression-free and overall survival rates were 61% and 72%, respectively. Conclusions: This combination appears safe, has encouraging activity, and deserves further studies in locally advanced HNSCC.« less

Preparation and characterization of magnetic nanocomposite of Schiff base/silica/magnetite as a preconcentration phase for the trace determination of heavy metal ions in water, food and biological samples using atomic absorption spectrometry.

PubMed

Bagheri, Hasan; Afkhami, Abbas; Saber-Tehrani, Mohammad; Khoshsafar, Hosein

2012-08-15

A versatile and robust solid phase with both magnetic property and a very high adsorption capacity is presented on the basis of modification of iron oxide-silica magnetic particles with a newly synthesized Schiff base (Fe(3)O(4)/SiO(2)/L). The structure of the resulting product was confirmed by Fourier transform infrared (FT-IR) spectra, X-ray diffraction (XRD) spectrometry and transmission electron microscopy (TEM). We developed an efficient and cost-effective method for the preconcentration of trace amounts of Pb(II), Cd(II) and Cu(II) in environmental and biological samples using this novel magnetic solid phase. Prepared magnetic solid phase is an ideal support because it has a large surface area, good selectivity and can be easily retrieved from large volumes of aqueous solutions. The possible parameters affecting the enrichment were optimized. Under the optimal conditions, the method detection limit was 0.14, 0.19 and 0.12 μg L(-1) for Pb(II), Cd(II) and Cu(II) ions, respectively. The established method has been successfully applied to analyze real samples, and satisfactory results were obtained. All these indicated that this magnetic phase had a great potential in environmental and biological fields. Copyright © 2012 Elsevier B.V. All rights reserved.

Online Screening and Referral for Postpartum Depression: An Exploratory Study

PubMed Central

Drake, Emily; Gustavson, Erica; Kinsey, Emily

2013-01-01

The fear and stigma associated with Postpartum Depression (PPD) is a major challenge in the treatment of this disease. Our goal is to develop innovative methods of screening women for the symptoms of PPD to facilitate referral and treatment. This study explores the efficacy of the Internet in reaching out to postpartum women in the convenience and privacy of their own homes, particularly those in rural and underserved areas. An exploratory study design was used to explore the feasibility and acceptability of online screening for PPD with postpartum women in the first 2–3 months after delivery (N=18). In the first phase, a focus group was conducted with a small group of postpartum women; the second phase consisted of individual interviews of postpartum women in their homes; and in phase three, 10 women participated in the on-line screening intervention. Postpartum depression was measured using an online version of the Edinburgh Postnatal Depression Scale (EPDS) a well-established instrument with reported alpha reliabilities (0.81–0.88) across studies and concurrent validity demonstrated using the gold standard, DSM IV criteria for depression interview. Qualitative data collected from all the participants were also analyzed. The sample included women age 18–29; 70% White/Caucasian, 50% low income, and the majority living in rural areas. The EPDS scores ranged from 0–13 (mean 8.0; SD 4.76). Participants described the online PPD screening process as easy, straightforward and personalized and provided additional suggestions for improvement. PMID:23283485

Phase I/II Study of Weekly Oraxol for the Second-Line Treatment of Patients With Metastatic or Recurrent Gastric Cancer.

PubMed

Lee, Keun-Wook; Lee, Kyung Hee; Zang, Dae Young; Park, Young Iee; Shin, Dong Bok; Kim, Jin Won; Im, Seock-Ah; Koh, Sung Ae; Yu, Kyung-Sang; Cho, Joo-Youn; Jung, Jin-A; Bang, Yung-Jue

2015-08-01

Oraxol consists of paclitaxel and HM30181A, a P-glycoprotein inhibitor, to increase the oral bioavailability of paclitaxel. This phase I/II study (HM-OXL-201) was conducted to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Oraxol. In addition, we investigated the efficacy and safety of Oraxol as second-line chemotherapy for metastatic or recurrent gastric cancer (GC). In the phase I component, paclitaxel was orally administered at escalating doses (90, 120, or 150 mg/m(2) per day) with a fixed dose (15 mg/day) of HM30181A. Oraxol was administrated 6 times per cycle (days 1, 2, 8, 9, 15, and 16) every 4 weeks. In the phase II component, the efficacy and safety of Oraxol were evaluated. In the phase I component, the MTD could not be determined. Based on toxicity and pharmacokinetic data, the RP2D of oral paclitaxel was determined to be 150 mg/m(2). In the phase II component, 4 of 43 patients (9.3%) achieved partial responses. Median progression-free survival and overall survival were 2.6 and 10.7 months, respectively. Toxicity profiles were favorable, and the most common drug-related adverse events (grade ≥3) were neutropenia and diarrhea. Oraxol exhibited modest efficacy and favorable toxicity profiles as second-line chemotherapy for GC. ©AlphaMed Press; the data published online to support this summary is the property of the authors.

Growth-differentiation factor-15, endoglin and N-terminal pro-brain natriuretic peptide induction in athletes participating in an ultramarathon foot race.

PubMed

Tchou, Isabelle; Margeli, Alexandra; Tsironi, Maria; Skenderi, Katerina; Barnet, Marc; Kanaka-Gantenbein, Christina; Papassotiriou, Ioannis; Beris, Photis

2009-09-01

We investigated the actions of growth-differentiation factor (GDF)-15, endoglin and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) in 15 male athletes who participated in the ultradistance foot race of the 246 km 'Sparthathlon'. Measurements were performed before (phase I), at the end of the race (phase II) and 48 h post-race (phase III). GDF-15 and endoglin serum concentrations were determined with enzyme-linked immunosorbent assay and NT-pro-BNP plasma levels by electrochemiluminescence. GDF-15 levels were increased from phase I (563.9 +/- 57.1 pg ml(-1)) to phase II (2311.1 +/- 462.3 pg ml(-1)) and decreased at phase III (862.0 +/- 158.0 pg ml(-1)) (p < 0.0002). NT-pro-BNP levels followed a similar pattern to that of GDF-15 from 38.1 +/- 4.8 pg ml(-1) at phase I to 1280.6 +/- 259.0 pg ml(-1) at phase II and 89.8 +/- 13.6 pg ml(-1) at phase III (p < 0.0001) and at the same time points, endoglin levels were 4.7 +/- 0.2 ng ml(-1) at phase I, 5.8 +/- 0.2 ng ml(-1) at phase II and 4.3 +/- 0.2 ng ml(-1) at phase III (p < 0.002). These findings indicate that circulating GDF-15, endoglin and NT-pro-BNP levels reflect a transient endothelial dysfunction in these athletes who participated in a foot race consisting of continuous, prolonged and brisk exercise.

South Bay Salt Pond Restoration, Phase II at Ravenswood

EPA Pesticide Factsheets

Information about the South Bay Salt Pond Restoration Project: Phase II Construction at Ravenswood, part of an EPA competitive grant program to improve SF Bay water quality focused on restoring impaired waters and enhancing aquatic resources.

Carbon footprint estimator, phase II : volume II - technical appendices.

DOT National Transportation Integrated Search

2014-03-01

The GASCAP model was developed to provide a software tool for analysis of the life-cycle GHG : emissions associated with the construction and maintenance of transportation projects. This phase : of development included techniques for estimating emiss...

Morristown Alternative Transportation Study Phase II.

DOT National Transportation Integrated Search

2005-10-14

This report summarizes the Phase II planning effort conducted by the park and the US Department of Transportation's Volpe Center (the Volpe Center) to articulate a viable park-community pilot transit service for Morristown National Historical Park. M...

The topological pressure-temperature phase diagram of ritonavir, an extraordinary case of crystalline dimorphism.

PubMed

Céolin, R; Rietveld, I B

2015-01-01

A topological pressure-temperature phase diagram involving the phase relationships of ritonavir forms I and II has been constructed using experimental calorimetric and volumetric data available from the literature. The triple point I-II-liquid is located at a temperature of about 407 K and a pressure as extraordinarily small as 17.5 MPa (175 bar). Thus, the less soluble solid phase (form II) will become metastable on increasing pressure. At room temperature, form I becomes stable around 100 MPa indicating that form II may turn into form I at a relatively low pressure of 1000 bar, which may occur under processing conditions such as mixing or grinding. This case is a good example for which a proper thermodynamic evaluation trumps "rules of thumb" such as the density rule. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Detailed validation of the bidirectional effect in various Case I and Case II waters.

PubMed

Gleason, Arthur C R; Voss, Kenneth J; Gordon, Howard R; Twardowski, Michael; Sullivan, James; Trees, Charles; Weidemann, Alan; Berthon, Jean-François; Clark, Dennis; Lee, Zhong-Ping

2012-03-26

Simulated bidirectional reflectance distribution functions (BRDF) were compared with measurements made just beneath the water's surface. In Case I water, the set of simulations that varied the particle scattering phase function depending on chlorophyll concentration agreed more closely with the data than other models. In Case II water, however, the simulations using fixed phase functions agreed well with the data and were nearly indistinguishable from each other, on average. The results suggest that BRDF corrections in Case II water are feasible using single, average, particle scattering phase functions, but that the existing approach using variable particle scattering phase functions is still warranted in Case I water.

Mechanochemical induced structural changes in sucrose using the rotational diamond anvil cell

NASA Astrophysics Data System (ADS)

Ciezak-Jenkins, Jennifer A.; Jenkins, Timothy A.

2018-02-01

The response of sucrose to high-pressure and shear conditions has been studied in a rotational diamond anvil cell. Previous experiments conducted by Bridgman and Teller showed divergent behavior in regard to the existence of a rheological explosion under mechanochemical stimuli. Raman spectroscopy confirmed the existence of the isostructural Phase I to Phase II transition near 5 GPa. When subjected to high-pressure and shear, Raman spectra of Phase I showed evidence that while the sucrose molecule underwent significant molecular deformation, there was no evidence of a complete chemical reaction. In contrast, Phase II showed a near-total loss of the in-situ Raman signal in response to shear, suggesting the onset of amorphization or decomposition. The divergent behaviors of Phase I and Phase II are examined in light of the differences in the hydrogen bonding and plasticity of the material.

Safety profile and clinical activity of sifalimumab, a fully human anti-interferon α monoclonal antibody, in systemic lupus erythematosus: a phase I, multicentre, double-blind randomised study.

PubMed

Merrill, Joan T; Wallace, Daniel J; Petri, Michelle; Kirou, Kyriakos A; Yao, Yihong; White, Wendy I; Robbie, Gabriel; Levin, Robert; Berney, Seth M; Chindalore, Vishala; Olsen, Nancy; Richman, Laura; Le, Chenxiong; Jallal, Bahija; White, Barbara

2011-11-01

Type I interferons (IFNs) appear to play a central role in disease pathogenesis in systemic lupus erythematosus (SLE), making them potential therapeutic targets. Safety profile, pharmacokinetics, immunogenicity, pharmacodynamics and clinical activity of sifalimumab, an anti-IFNα monoclonal antibody, were assessed in a phase I, multicentre, randomised, double-blind, dose-escalation study with an open-label extension in adults with moderately active SLE. received one intravenous dose of sifalimumab (n=33 blinded phase, 0.3, 1, 3, 10 or 30 mg/kg; n=17 open-label, 1, 3, 10 or 30 mg/kg) or placebo (n=17). Each phase lasted 84 days. Adverse events (AEs) were similar between groups; about 97% of AEs were grade 1 or 2. All grade 3 and 4 AEs and all serious AEs (2 placebo, 1 sifalimumab) were deemed unrelated to the study drug. No increase in viral infections or reactivation was observed. Sifalimumab caused dose-dependent inhibition of type I IFN-induced mRNAs (type I IFN signature) in whole blood and corresponding changes in related proteins in affected skin. Exploratory analyses showed consistent trends toward improvement in disease activity in sifalimumab-treated versus placebo-treated subjects. A lower proportion of sifalimumab-treated subjects required new or increased immunosuppressive treatments (12% vs 41%; p=0.03) and had fewer Systemic Lupus Erythematosus Disease Activity Index flares (3% vs 29%; p=0.014). Sifalimumab had a safety profile that supports further clinical development. This trial demonstrated that overexpression of type I IFN signature in SLE is at least partly driven by IFNα, and exploratory analyses suggest that IFNα inhibition may be associated with clinical benefit in SLE. Trial registration number NCT00299819.

Saw Palmetto for Symptom Management During Radiation Therapy for Prostate Cancer.

PubMed

Wyatt, Gwen K; Sikorskii, Alla; Safikhani, Abolfazl; McVary, Kevin T; Herman, James

2016-06-01

Lower urinary tract symptoms (LUTSs) affect 75%-80% of men undergoing radiation therapy (RT) for prostate cancer. To determine the safety, maximum tolerated dose (MTD), and preliminary efficacy of Serenoa repens commonly known as saw palmetto (SP) for management of LUTS during RT for prostate cancer. The dose finding phase used the time-to-event continual reassessment method to evaluate safety of three doses (320, 640, and 960 mg) of SP. Dose-limiting toxicities were assessed for 22 weeks using the Common Terminology Criteria for Adverse Events for nausea, gastritis, and anorexia. The exploratory randomized controlled trial phase assessed preliminary efficacy of the MTD against placebo. The primary outcome of LUTS was measured over 22 weeks using the International Prostate Symptom Score. Additional longitudinal assessments included quality of life measured with the Functional Assessment of Cancer Therapy-Prostate. The dose finding phase was completed by 27 men who reported no dose-limiting toxicities and with 20 participants at the MTD of 960 mg daily. The exploratory randomized controlled trial phase included 21 men, and no statistically significant differences in the International Prostate Symptom Score were observed. The prostate-specific concerns score of the Functional Assessment of Cancer Therapy-Prostate improved in the SP group (P = 0.03). Of 11 men in the placebo group, two received physician-prescribed medications to manage LUTS compared with none of the 10 men in the SP group. SP at 960 mg may be a safe herbal supplement, but its efficacy in managing LUTS during RT needs further investigation. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Predicting response to primary chemotherapy: gene expression profiling of paraffin-embedded core biopsy tissue.

PubMed

Mina, Lida; Soule, Sharon E; Badve, Sunil; Baehner, Fredrick L; Baker, Joffre; Cronin, Maureen; Watson, Drew; Liu, Mei-Lan; Sledge, George W; Shak, Steve; Miller, Kathy D

2007-06-01

Primary chemotherapy provides an ideal opportunity to correlate gene expression with response to treatment. We used paraffin-embedded core biopsies from a completed phase II trial to identify genes that correlate with response to primary chemotherapy. Patients with newly diagnosed stage II or III breast cancer were treated with sequential doxorubicin 75 mg/M2 q2 wks x 3 and docetaxel 40 mg/M2 weekly x 6; treatment order was randomly assigned. Pretreatment core biopsy samples were interrogated for genes that might correlate with pathologic complete response (pCR). In addition to the individual genes, the correlation of the Oncotype DX Recurrence Score with pCR was examined. Of 70 patients enrolled in the parent trial, core biopsies samples with sufficient RNA for gene analyses were available from 45 patients; 9 (20%) had inflammatory breast cancer (IBC). Six (14%) patients achieved a pCR. Twenty-two of the 274 candidate genes assessed correlated with pCR (p < 0.05). Genes correlating with pCR could be grouped into three large clusters: angiogenesis-related genes, proliferation related genes, and invasion-related genes. Expression of estrogen receptor (ER)-related genes and Recurrence Score did not correlate with pCR. In an exploratory analysis we compared gene expression in IBC to non-inflammatory breast cancer; twenty-four (9%) of the genes were differentially expressed (p < 0.05), 5 were upregulated and 19 were downregulated in IBC. Gene expression analysis on core biopsy samples is feasible and identifies candidate genes that correlate with pCR to primary chemotherapy. Gene expression in IBC differs significantly from noninflammatory breast cancer.

Examination of Org 26576, an AMPA receptor positive allosteric modulator, in patients diagnosed with major depressive disorder: an exploratory, randomized, double-blind, placebo-controlled trial.

PubMed

Nations, Kari R; Dogterom, Peter; Bursi, Roberta; Schipper, Jacques; Greenwald, Scott; Zraket, David; Gertsik, Lev; Johnstone, Jack; Lee, Allen; Pande, Yogesh; Ruigt, Ge; Ereshefsky, Larry

2012-12-01

Org 26576 acts by modulating ionotropic AMPA-type glutamate receptors to enhance glutamatergic neurotransmission. The aim of this Phase 1b study (N=54) was to explore safety, tolerability, pharmacokinetics, and pharmacodynamics of Org 26576 in depressed patients. Part I (N=24) evaluated the maximum tolerated dose (MTD) and optimal titration schedule in a multiple rising dose paradigm (range 100 mg BID to 600 mg BID); Part II (N=30) utilized a parallel groups design (100 mg BID, 400 mg BID, placebo) to examine all endpoints over a 28-day dosing period. Based on the number of moderate intensity adverse events reported at the 600 mg BID dose level, the MTD established in Part I was 450 mg BID. Symptomatic improvement as measured by the Montgomery-Asberg Depression Rating Scale was numerically greater in the Org 26576 groups than in the placebo group in both study parts. In Part II, the 400 mg BID dose was associated with improvements in executive functioning and speed of processing cognitive tests. Org 26576 was also associated with growth hormone increases and cortisol decreases at the end of treatment but did not influence prolactin or brain-derived neurotrophic factor. The quantitative electroencephalogram index Antidepressant Treatment Response at Week 1 was able to significantly predict symptomatic response at endpoint in the active treatment group, as was early improvement in social acuity. Overall, Org 26576 demonstrated good tolerability and pharmacokinetic properties in depressed patients, and pharmacodynamic endpoints suggested that it may show promise in future well-controlled, adequately powered proof of concept trials.

The James Supportive Care Screening: integrating science and practice to meet the NCCN guidelines for distress management at a Comprehensive Cancer Center.

PubMed

Wells-Di Gregorio, Sharla; Porensky, Emily K; Minotti, Matthew; Brown, Susan; Snapp, Janet; Taylor, Robert M; Adolph, Michael D; Everett, Sherman; Lowther, Kenneth; Callahan, Kelly; Streva, Devita; Heinke, Vicki; Leno, Debra; Flower, Courtney; McVey, Anne; Andersen, Barbara Lee

2013-09-01

Selecting a measure for oncology distress screening can be challenging. The measure must be brief, but comprehensive, capturing patients' most distressing concerns. The measure must provide meaningful coverage of multiple domains, assess symptom and problem-related distress, and ideally be suited for both clinical and research purposes. From March 2006 to August 2012, the James Supportive Care Screening (SCS) was developed and validated in three phases including content validation, factor analysis, and measure validation. Exploratory factor analyses were completed with 596 oncology patients followed by a confirmatory factor analysis with 477 patients. Six factors were identified and confirmed including (i) emotional concerns; (ii) physical symptoms; (iii) social/practical problems; (iv) spiritual problems; (v) cognitive concerns; and (vi) healthcare decision making/communication issues. Subscale evaluation reveals good to excellent internal consistency, test-retest reliability, and convergent, divergent, and predictive validity. Specificity of individual items was 0.90 and 0.87, respectively, for identifying patients with DSM-IV-TR diagnoses of major depression and generalized anxiety disorder. Results support use of the James SCS to quickly detect the most frequent and distressing symptoms and concerns of cancer patients. The James SCS is an efficient, reliable, and valid clinical and research outcomes measure. Copyright © 2013 John Wiley & Sons, Ltd.

Construct Validation of Three Nutrition Questions Using Health and Diet Ratings in Older Canadian Males Living in the Community.

PubMed

Akhtar, Usman; Keller, Heather H; Tate, Robert B; Lengyel, Christina O

2015-12-01

Brief nutrition screening tools are desired for research and practice. Seniors in the Community: Risk Evaluation for Eating and Nutrition (SCREEN-II, 14 items) and the abbreviated version SCREEN-II-AB (8 items) are valid and reliable nutrition screening tools for older adults. This exploratory study used a retrospective cross-sectional design to determine the construct validity of a subset of 3 items (weight loss, appetite, and swallowing difficulty) currently on the SCREEN-II and SCREEN-II-AB tools. Secondary data on community-dwelling senior males (n = 522, mean ± SD age = 86.7 ± 3.0 years) in the Manitoba Follow-up Study (MFUS) study were available for analysis. Participants completed the mailed MFUS Nutrition Survey that included SCREEN-II items and questions pertaining to self-rated health, diet healthiness, and rating of the importance of nutrition towards successful aging as the constructs for comparison. Self-perceived health status (F = 14.7, P < 0.001), diet healthiness (ρ = 0.17, P = 0.002) and the rating of nutrition's importance to aging (ρ = 0.10, P = 0.03) were correlated with the 3-item score. Inferences were consistent with associations between these construct variables and the full SCREEN-II. Three items from SCREEN-II and SCREEN-II-AB demonstrate initial construct validity with self-perceived health status and diet healthiness ratings by older males; further exploration for criterion and predictive validity in more diverse samples is needed.

Pavement performance evaluation, phase II : data collection.

DOT National Transportation Integrated Search

2008-12-01

Phase I and II of this study tested approximately 1500 rehabilitated pavements (asphalt and PCC) : throughout the State. These pavements ranged from 5 to 15 years old and were intended to develop a : snapshot of how various rehabilitations were perfo...

Improving traffic safety culture in Iowa : phase II.

DOT National Transportation Integrated Search

2013-07-01

Phase II of Improving Traffic Safety Culture in Iowa focuses on producing actions that will improve the traffic safety culture across the state, and involves collaboration among the three large public universities in Iowa: Iowa State University, Univ...

South Bay Salt Pond Tidal Wetland Restoration Phase II Planning

EPA Pesticide Factsheets

Information about the SFBWQP South Bay Salt Pond Tidal Wetland Restoration Phase II Planning project, part of an EPA competitive grant program to improve SF Bay water quality focused on restoring impaired waters and enhancing aquatic re

Perceived Breastfeeding Support Assessment Tool (PBSAT): development and testing of psychometric properties with Pakistani urban working mothers.

PubMed

Hirani, Shela Akbar Ali; Karmaliani, Rozina; Christie, Thomas; Parpio, Yasmin; Rafique, Ghazala

2013-06-01

breast feeding is an essential source of nutrition among young babies; however, in Pakistan a gradual decline in prevalence of breast feeding, especially among urban working mothers, has been reported. Previous studies among Pakistani urban working mothers have revealed that ensuring exclusivity and continuation of breast feeding is challenging if social and/or workplace environmental support is minimal or absent. This problem indicated a crucial need to assess availability of breast-feeding support for Pakistani urban working mothers by using a comprehensive, reliable, and validated tool in their national language (Urdu). to develop and test the psychometric properties of the 'Perceived Breastfeeding Support Assessment Tool' (PBSAT) that can gauge Pakistani urban working mothers' perceptions about breast-feeding support. this methodological research was undertaken in five phases. During phase I, a preliminary draft of the PBSAT was developed by using the Socio-ecological model, reviewing literature, and referring to two United States based tools. In Phase II, the instrument was evaluated by seven different experts, and, in Phase III, the instrument was revised, translated, and back translated. In Phase IV, the tool was pilot tested among 20 participants and then modified on the basis of statistical analysis. In Phase V, the refined instrument was tested on 200 breast-feeding working mothers recruited through purposive sampling from the government and private health-care settings in Karachi, Pakistan. Approvals were received from the Ethical Review Committees of the identified settings. the 29-item based PBSAT revealed an acceptable inter-rater reliability of 0.95, and an internal consistency reliability coefficient (Cronbach's alpha) of 0.85. A construct validity assessment through Exploratory Factor Analysis revealed that the PBSAT has two dimensions, 'workplace environmental support' (12 items; α=0.86) and 'social environmental support' (17 items; α=0.77). the study developed a 29-item based two-dimensional tool (in Urdu) that has acceptable psychometric properties. The PBSAT is context specific, comprehensive, and user-friendly, so it can be administered by health-care workers, employers, policy makers, and researchers to improve the quality of services of breast-feeding urban working mothers, and could ultimately improve child health in Pakistan. Copyright © 2012 Elsevier Ltd. All rights reserved.

Thermodynamic, crystallographic, and dielectric study of the nature of glass transitions in cyclo-octanol

NASA Astrophysics Data System (ADS)

Puertas, Ricardo; Rute, Maria A.; Salud, Josep; López, David O.; Diez, Sergio; van Miltenburg, J. Kees; Pardo, Luis C.; Tamarit, Josep Ll.; Barrio, Maria; Pérez-Jubindo, Miguel A.; de La Fuente, Maria R.

2004-06-01

The stable solid polymorphism of cyclooctanol (C8H16O, for short C8 OH) is revealed to be a complex problem and only two stable solid phases, denoted on cooling from the liquid as phases I and II, are found using static (thermodynamic and x-ray diffraction) as well as dynamic (dielectric spectroscopy) experimental techniques. Both solid phases are known to exhibit glass transitions if they are cooled down fast enough to prevent transition to ordered crystalline states. Although glass transitions corresponding to both phases had been well documented by means of specific heat measurements, x-ray measurements constitute, as far as we know, the first evidence from the structural point of view. In addition, a great amount of dielectric works devoted to phase I and its glass transition, were published in the past but next to nothing relating to the dielectric properties of phase II and its glass transition. The nature of the disorder of phase II will be discussed.

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

PubMed

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.

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review

PubMed Central

Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

2017-01-01

Background 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. Data sources A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010–2015). Study eligibility criteria 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. Intervention Quality of reporting was assessed using the Key Methodological Score. Results 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). Limitations Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. Conclusions & implications of key findings 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. PMID:29216190

Characterization of pH dependent Mn(II) oxidation strategies and formation of a bixbyite-like phase by Mesorhizobium australicum T-G1

USGS Publications Warehouse

Bohu, Tsing; Santelli, Cara M; Akob, Denise M.; Neu, Thomas R; Ciobota, Valerian; Rösch, Petra; Popp, Jürgen; Nietzsche, Sándor; Küsel, Kirsten

2015-01-01

Despite the ubiquity of Mn oxides in natural environments, there are only a few observations of biological Mn(II) oxidation at pH < 6. The lack of low pH Mn-oxidizing bacteria (MOB) isolates limits our understanding of how pH influences biological Mn(II) oxidation in extreme environments. Here, we report that a novel MOB isolate, Mesorhizobium australicum strain T-G1, isolated from an acidic and metalliferous uranium mining area, can oxidize Mn(II) at both acidic and neutral pH using different enzymatic pathways. X-ray diffraction, Raman spectroscopy, and scanning electron microscopy with energy dispersive X-ray spectroscopy revealed that T-G1 initiated bixbyite-like Mn oxide formation at pH 5.5 which coincided with multi-copper oxidase expression from early exponential phase to late stationary phase. In contrast, reactive oxygen species (ROS), particularly superoxide, appeared to be more important for T-G1 mediated Mn(II) oxidation at neutral pH. ROS was produced in parallel with the occurrence of Mn(II) oxidation at pH 7.2 from early stationary phase. Solid phase Mn oxides did not precipitate, which is consistent with the presence of a high amount of H2O2 and lower activity of catalase in the liquid culture at pH 7.2. Our results show that M. australicum T-G1, an acid tolerant MOB, can initiate Mn(II) oxidation by varying its oxidation mechanisms depending on the pH and may play an important role in low pH manganese biogeochemical cycling.

Characterization of pH dependent Mn(II) oxidation strategies and formation of a bixbyite-like phase by Mesorhizobium australicum T-G1.

PubMed

Bohu, Tsing; Santelli, Cara M; Akob, Denise M; Neu, Thomas R; Ciobota, Valerian; Rösch, Petra; Popp, Jürgen; Nietzsche, Sándor; Küsel, Kirsten

2015-01-01

Despite the ubiquity of Mn oxides in natural environments, there are only a few observations of biological Mn(II) oxidation at pH < 6. The lack of low pH Mn-oxidizing bacteria (MOB) isolates limits our understanding of how pH influences biological Mn(II) oxidation in extreme environments. Here, we report that a novel MOB isolate, Mesorhizobium australicum strain T-G1, isolated from an acidic and metalliferous uranium mining area, can oxidize Mn(II) at both acidic and neutral pH using different enzymatic pathways. X-ray diffraction, Raman spectroscopy, and scanning electron microscopy with energy dispersive X-ray spectroscopy revealed that T-G1 initiated bixbyite-like Mn oxide formation at pH 5.5 which coincided with multi-copper oxidase expression from early exponential phase to late stationary phase. In contrast, reactive oxygen species (ROS), particularly superoxide, appeared to be more important for T-G1 mediated Mn(II) oxidation at neutral pH. ROS was produced in parallel with the occurrence of Mn(II) oxidation at pH 7.2 from early stationary phase. Solid phase Mn oxides did not precipitate, which is consistent with the presence of a high amount of H2O2 and lower activity of catalase in the liquid culture at pH 7.2. Our results show that M. australicum T-G1, an acid tolerant MOB, can initiate Mn(II) oxidation by varying its oxidation mechanisms depending on the pH and may play an important role in low pH manganese biogeochemical cycling.

Specific threonine-4 phosphorylation and function of RNA polymerase II CTD during M phase progression

PubMed Central

Hintermair, Corinna; Voß, Kirsten; Forné, Ignasi; Heidemann, Martin; Flatley, Andrew; Kremmer, Elisabeth; Imhof, Axel; Eick, Dirk

2016-01-01

Dynamic phosphorylation of Tyr1-Ser2-Pro3-Thr4-Ser5-Pro6-Ser7 heptad-repeats in the C-terminal domain (CTD) of the large subunit coordinates progression of RNA polymerase (Pol) II through the transcription cycle. Here, we describe an M phase-specific form of Pol II phosphorylated at Thr4, but not at Tyr1, Ser2, Ser5, and Ser7 residues. Thr4 phosphorylated Pol II binds to centrosomes and midbody and interacts with the Thr4-specific Polo-like kinase 1. Binding of Pol II to centrosomes does not require the CTD but may involve subunits of the non-canonical R2TP-Prefoldin-like complex, which bind to and co-localize with Pol II at centrosomes. CTD Thr4 mutants, but not Ser2 and Ser5 mutants, display severe mitosis and cytokinesis defects characterized by multipolar spindles and polyploid cells. We conclude that proper M phase progression of cells requires binding of Pol II to centrosomes to facilitate regulation of mitosis and cytokinesis in a CTD Thr4-P dependent manner. PMID:27264542

Specific threonine-4 phosphorylation and function of RNA polymerase II CTD during M phase progression.

PubMed

Hintermair, Corinna; Voß, Kirsten; Forné, Ignasi; Heidemann, Martin; Flatley, Andrew; Kremmer, Elisabeth; Imhof, Axel; Eick, Dirk

2016-06-06

Dynamic phosphorylation of Tyr1-Ser2-Pro3-Thr4-Ser5-Pro6-Ser7 heptad-repeats in the C-terminal domain (CTD) of the large subunit coordinates progression of RNA polymerase (Pol) II through the transcription cycle. Here, we describe an M phase-specific form of Pol II phosphorylated at Thr4, but not at Tyr1, Ser2, Ser5, and Ser7 residues. Thr4 phosphorylated Pol II binds to centrosomes and midbody and interacts with the Thr4-specific Polo-like kinase 1. Binding of Pol II to centrosomes does not require the CTD but may involve subunits of the non-canonical R2TP-Prefoldin-like complex, which bind to and co-localize with Pol II at centrosomes. CTD Thr4 mutants, but not Ser2 and Ser5 mutants, display severe mitosis and cytokinesis defects characterized by multipolar spindles and polyploid cells. We conclude that proper M phase progression of cells requires binding of Pol II to centrosomes to facilitate regulation of mitosis and cytokinesis in a CTD Thr4-P dependent manner.

Implementation of a Proficiency-Based Diploma System in Maine: Phase II--District Level Analysis

ERIC Educational Resources Information Center

Silvernail, David L.; Stump, Erika K.; McCafferty, Anita Stewart; Hawes, Kathryn M.

2014-01-01

This report describes the findings from Phase II of a study of Maine's implementation of a proficiency-based diploma system. At the request of the Joint Standing Committee on Education and Cultural Affairs of the Maine Legislature, the Maine Policy Research Institute (MEPRI) has conducted a two-phased study of the implementation of Maine law…

40 CFR 76.8 - Early election for Group 1, Phase II boilers.

Code of Federal Regulations, 2010 CFR

2010-07-01

... PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.8 Early election for Group 1... plan and: (i) If a Phase I Acid Rain permit governing the source at which the unit is located has been... chapter to include the early election plan; or (ii) If a Phase I Acid Rain permit governing the source at...

40 CFR 76.8 - Early election for Group 1, Phase II boilers.

Code of Federal Regulations, 2014 CFR

2014-07-01

... PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.8 Early election for Group 1... plan and: (i) If a Phase I Acid Rain permit governing the source at which the unit is located has been... chapter to include the early election plan; or (ii) If a Phase I Acid Rain permit governing the source at...

40 CFR 76.8 - Early election for Group 1, Phase II boilers.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.8 Early election for Group 1... plan and: (i) If a Phase I Acid Rain permit governing the source at which the unit is located has been... chapter to include the early election plan; or (ii) If a Phase I Acid Rain permit governing the source at...

40 CFR 76.8 - Early election for Group 1, Phase II boilers.

Code of Federal Regulations, 2012 CFR

2012-07-01

... PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.8 Early election for Group 1... plan and: (i) If a Phase I Acid Rain permit governing the source at which the unit is located has been... chapter to include the early election plan; or (ii) If a Phase I Acid Rain permit governing the source at...

40 CFR 76.8 - Early election for Group 1, Phase II boilers.

Code of Federal Regulations, 2013 CFR

2013-07-01

... PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.8 Early election for Group 1... plan and: (i) If a Phase I Acid Rain permit governing the source at which the unit is located has been... chapter to include the early election plan; or (ii) If a Phase I Acid Rain permit governing the source at...

Extension and Public Service in the University of Illinois. Phase II Report.

ERIC Educational Resources Information Center

Illinois Univ., Urbana.

Phase II of the report on the problem outlined in Phase I deals with specific recommendations for expanding and improving the extension and public service functions of the University of Illinois. To be effective, the university needs a master plan in which the four essential ingredients must be (1) broad, strong and explicit policy commitments by…

A Report on the Navy SBIR Program: Best Practices, Roadblocks and Recommendations for Technology Transition

DTIC Science & Technology

2008-04-01

a recommendation to the Phase I Sponsor, the NAVSEA SBIR Program Manager, and the PCO between 90 and 180 days after Phase I contract execution...determine eligibility for Phase II and send recommendations to sponsor Between 90 and 180 days after contract execution PCO Invites Phase II Proposals...manning study to evaluate the claim of inadequate numbers of contracting personnel. Although there were symptoms that contract delays were in part

Comparison between the phase I and phase II 6 m coke oven batteries of C. Still type in China Steel Corporation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Chiao-Hwa, H.; Tai-Heng, C.; Cheng-Hwa, L.

1983-01-01

The 98 ovens built for phase II batteries at China Steel Corporation show significant improvements over those of phase I, although they are operated in series with these. Improvements discussed in this paper include those associated with the single collection main, water sealing for the ascension pipe, aspiration by high pressure flushing liquor, self-sealing doors, wall head armour structures, waste gas flues and thermal efficiency.

Removal and recovery of mercury(II) from hazardous wastes using 1-(2-thiazolylazo)-2-naphthol functionalized activated carbon as solid phase extractant.

PubMed

Starvin, A M; Rao, T Prasada

2004-09-10

As a part of removal of toxic heavy metals from hazardous wastes, solid phase extraction (SPE) of mercury(II) at trace and ultra trace levels was studied using 1-(2-thiazolylazo)-2-naphthol (TAN) functionalized activated carbon (AC). The SPE material removes traces of mercury(II) quantitatively in the pH range 6.0 +/- 0.2. Other parameters that influence quantitative recovery of mercury(II), viz. percent concentration of TAN in AC, amount of TAN-AC, preconcentration time and volume of aqueous phase were varied and optimized. The possible means of removal of Hg(II) from other metal ions that are likely to be present in the wastes of the chloroalkali industry is discussed. The potential of TAN-functionalized AC SPE material for decontaminating mercury from the brine sludge and cell house effluent of a chloralkali plant has been evaluated.

Caltrans WeatherShare Phase II System: An Application of Systems and Software Engineering Process to Project Development

DOT National Transportation Integrated Search

2009-08-25

In cooperation with the California Department of Transportation, Montana State University's Western Transportation Institute has developed the WeatherShare Phase II system by applying Systems Engineering and Software Engineering processes. The system...

Roadway lighting and safety : phase II--monitoring quality, durability and efficiency.

DOT National Transportation Integrated Search

2011-10-01

This Phase II project follows a previous project titled Strategies to Address Nighttime Crashes at Rural, Unsignalized Intersections. Based on the results of the previous study, the Iowa Highway Research Board (IHRB) indicated interest in pursuing fu...

North Carolina "Sealed Corridor" Phase I, II, and III Assessment

DOT National Transportation Integrated Search

2009-10-01

The Federal Railroad Administration (FRA) tasked the John A. Volpe National Transportation Systems Center to document the further success of the North Carolina DOT "Sealed Corridor" project through Phases I, II, and III. The Sealed Corridor is the se...

Final report of evaluation of masonry coatings : phase II.

DOT National Transportation Integrated Search

1972-11-01

This research project was undertaken to evaluate several coating systems for concrete masonry to replace the presently used Class 2 rubbed finish. This is the report of Phase II, the field evaluation, of that project. : In early October 1970, applica...

Evaluation of Phase II of the SmarTraveler advanced traveler information system : operational test

DOT National Transportation Integrated Search

1994-07-31

Under contract to the Massachusetts Highway Department, the Central Transportation : Planning Staff (technical staff to the Boston MPO) chose Multisystems, Inc. of : Cambridge, Massachusetts, to perform an evaluation of Phase II of the SmarTraveler :...

System design and architecture for the IDTO prototype : phase II demonstration site (central Florida).

DOT National Transportation Integrated Search

2015-05-01

This report documents the System Design and Architecture for the Phase II implementation of the Integrated Dynamic Transit Operations (IDTO) Prototype bundle within the Dynamic Mobility Applications (DMA) portion of the Connected Vehicle Program. Thi...

Research safety vehicle. Phase II. Volume II. comprehensive technical results. Final report July 1975--December 1976

DOE Office of Scientific and Technical Information (OSTI.GOV)

DiNapoli, N.; Fitzpatrick, M.; Strother, C.

1977-11-01

Phase I identified trends leading to the desired national social goals of the mid-1980's in vehicle crashworthiness, crash avoidance, damageability, pedestrian safety, fuel economy, emissions and cost, and characterized an RSV to satisfy them. In Phase II an RSV prototype was designed, developed and tested to demonstrate the feasibility of meeting these goals simultaneously. Although further refinement is necessary to assure operational validity, in all categories the results meet or exceed the most advanced performance specified by The Presidential Task Force on Motor Vehicle Goals beyond 1980.

Portable microfluidic platform for real-time, high sensitive detection and identification of trichloroethylene and other organochloride compounds

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jensen, Erik

In this successful SBIR Phase II effort, HJ Science & Technology, Inc. has designed and built a novel portable instrument capable of performing automated aqueous organochloride (chlorinated solvent) speciation analysis for environmental monitoring at DoE sites. Our technique employs performing organochloride conjugation, labeling the conjugate with an efficient fluorophore, and performing on-chip capillary electrophoresis separation with laser induced fluorescence detection. The key component of the portable instrument is a novel microfluidic chip capable of complete “end-to-end” automation of sample preparation, conjugation, labeling, and μCE separation and detection. In addition, the Phase II prototype includes key supporting instrumentation such as themore » optical module, pneumatic manifold, electronics, software, etc. As such, we have achieved all of the following 4 Phase II technical objectives: 1) Further refine and optimize the “on-chip” automation of the organochloride conjugation and labeling protocol, 2) Further improve the microfluidic chip fabrication process and the pneumatic manifold design in order to address issues related to performance consistency, product yield, performance reliability, and user friendliness, 3) Design and build the supporting components of the Phase II prototype including optical module, electronics, and software, and 4) Assemble the Phase II prototype hardware.« less

Phase I and II feasibility study report for the 300-FF-5 operable unit

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

1993-12-31

The purpose of this Phase I/II feasibility study is to assemble and screen a list of alternatives for remediation of the 300-FF-5 operable site on the Hanford Reservation. This screening is based on information gathered in the Phase I Remedial Investigation (RI) and on currently available information on remediation technologies. The alternatives remaining after screening provide a range of response actions for remediation. In addition, key data needs are identified for collection during a Phase II RI (if necessary). This Phase I/II FS represents a primary document as defined by the Tri-Party Agreement, but will be followed by a Phasemore » III FS that will further develop the alternatives and provide a detailed evaluation of them. The following remedial action objectives were identified for the 300-FF-5 operable unit: Limit current human exposure to contaminated groundwater in the unit; Limit discharge of contaminated groundwater to the Columbia River; Reduce contaminant concentrations in groundwater below acceptable levels by the year 2018.« less

Brominated flame retardants in Chinese air before and after the phase out of polybrominated diphenyl ethers

NASA Astrophysics Data System (ADS)

Li, Wen-Long; Qi, Hong; Ma, Wan-Li; Liu, Li-Yan; Zhang, Zhi; Mohammed, Mohammed O. A.; Song, Wei-Wei; Zhang, Zifeng; Li, Yi-Fan

2015-09-01

Brominated flame retardants (BFRs), including polybrominated diphenyl ethers (PBDEs) and novel non-BDE flame retardants (NBFRs), were analyzed in Chinese air during China's POPs Soil and Air Monitoring Program Phase I (SAMP-I) and Phase II (SAMP-II). The levels of Σ12PBDEs and Σ6NBFRs in urban sites were significantly higher than those in rural sites and background sites. The higher detection rate and concentrations of high molecular weight PBDEs and NBFRs in Phase II indicated the changing of the commercial pattern of BFRs after the phase out of PBDEs in China. Temperature was the major factor affecting the seasonal variations of molecular weight BFRs in atmosphere. A significant correlation between BFRs concentration and gross domestic product (GDP) was observed, with the GDP parameter explained 59.4% and 72.7% of the total variability for Octa-BDEs and low molecular weight NBFRs, respectively. Our findings indicated an evolving commercial usage of BFRs from SAMP-I to SAMP-II, i.e. shifting from lower molecular weight to higher molecular weight congeners in China.

Understanding decomposition and encapsulation energies of structure I and II clathrate hydrates

NASA Astrophysics Data System (ADS)

Alavi, Saman; Ohmura, Ryo

2016-10-01

When compressed with water or ice under high pressure and low temperature conditions, some gases form solid gas hydrate inclusion compounds which have higher melting points than ice under those pressures. In this work, we study the balance of the guest-water and water-water interaction energies that lead to the formation of the clathrate hydrate phases. In particular, molecular dynamics simulations with accurate water potentials are used to study the energetics of the formation of structure I (sI) and II (sII) clathrate hydrates of methane, ethane, and propane. The dissociation enthalpy of the clathrate hydrate phases, the encapsulation enthalpy of methane, ethane, and propane guests in the corresponding phases, and the average bonding enthalpy of water molecules are calculated and compared with accurate calorimetric measurements and previous classical and quantum mechanical calculations, when available. The encapsulation energies of methane, ethane, and propane guests stabilize the small and large sI and sII hydrate cages, with the larger molecules giving larger encapsulation energies. The average water-water interactions are weakened in the sI and sII phases compared to ice. The relative magnitudes of the van der Waals potential energy in ice and the hydrate phases are similar, but in the ice phase, the electrostatic interactions are stronger. The stabilizing guest-water "hydrophobic" interactions compensate for the weaker water-water interactions and stabilize the hydrate phases. A number of common assumptions regarding the guest-cage water interactions are used in the van der Waals-Platteeuw statistical mechanical theory to predict the clathrate hydrate phase stability under different pressure-temperature conditions. The present calculations show that some of these assumptions may not accurately reflect the physical nature of the interactions between guest molecules and the lattice waters.

Understanding decomposition and encapsulation energies of structure I and II clathrate hydrates.

PubMed

Alavi, Saman; Ohmura, Ryo

2016-10-21

When compressed with water or ice under high pressure and low temperature conditions, some gases form solid gas hydrate inclusion compounds which have higher melting points than ice under those pressures. In this work, we study the balance of the guest-water and water-water interaction energies that lead to the formation of the clathrate hydrate phases. In particular, molecular dynamics simulations with accurate water potentials are used to study the energetics of the formation of structure I (sI) and II (sII) clathrate hydrates of methane, ethane, and propane. The dissociation enthalpy of the clathrate hydrate phases, the encapsulation enthalpy of methane, ethane, and propane guests in the corresponding phases, and the average bonding enthalpy of water molecules are calculated and compared with accurate calorimetric measurements and previous classical and quantum mechanical calculations, when available. The encapsulation energies of methane, ethane, and propane guests stabilize the small and large sI and sII hydrate cages, with the larger molecules giving larger encapsulation energies. The average water-water interactions are weakened in the sI and sII phases compared to ice. The relative magnitudes of the van der Waals potential energy in ice and the hydrate phases are similar, but in the ice phase, the electrostatic interactions are stronger. The stabilizing guest-water "hydrophobic" interactions compensate for the weaker water-water interactions and stabilize the hydrate phases. A number of common assumptions regarding the guest-cage water interactions are used in the van der Waals-Platteeuw statistical mechanical theory to predict the clathrate hydrate phase stability under different pressure-temperature conditions. The present calculations show that some of these assumptions may not accurately reflect the physical nature of the interactions between guest molecules and the lattice waters.

Evaluation of hydrothermal resources of North Dakota. Phase II. Final technical report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Harris, K.L.; Howell, F.L.; Winczewski, L.M.

1981-06-01

This evaluation of the hydrothermal resources of North Dakota is based on existing data on file with the North Dakota Geological Survey (NDGS) and other state and federal agencies, and field and laboratory studies conducted. The principal sources of data used during the Phase II study were WELLFILE, the computer library of oil and gas well data developed during the Phase I study, and WATERCAT, a computer library system of water well data assembled during the Phase II study. A field survey of the shallow geothermal gradients present in selected groundwater observation holes was conducted. Laboratory determinations of the thermalmore » conductivity of core samples is being done to facilitate heat-flow calculations on those hole-of-convenience cased.« less

Proposing evidence-based strategies to strengthen implementation of healthcare reform in resource-limited settings: a summative analysis

PubMed Central

Manyazewal, Tsegahun; Oosthuizen, Martha J; Matlakala, Mokgadi C

2016-01-01

Objectives Many resource-limited countries have adopted and implemented healthcare reform to improve the quality of healthcare, but few have had much impact and strategies in support of these efforts remain limited. We aimed to explore and propose evidence-based strategies to strengthen implementation of healthcare reform in resource-limited settings. Design Descriptive and exploratory designs in two phases. Phase I involved assessing the effectiveness of the healthcare reform implemented in Ethiopia in the form of business process reengineering, with evidence compiled from healthcare professionals through a self-administered questionnaire; and phase II involved proposing strategies and seeking consensus from experts using Delphi method. Setting Public hospitals in central Ethiopia. Participants 406 healthcare professionals and 10 senior health policy experts. Findings The healthcare reform that we evaluated was able to restructure hospital departments into case teams, with the goal of adopting a ‘one-stop shopping’ approach. However, shortages of critical infrastructure, furniture and supplies and job dissatisfaction continued to hamper the system. The most important predictors that influenced implementation of the reform were financial resources, top management commitment and support, collaborative working environment and information technology (IT). Five strategies with 14 operational objectives and 67 potential interventions that could strengthen the reform are proposed based on their strategic priority, which are as follows: reinforce patient-centred quality of care services; foster a healthy and respectful workforce environment; efficient and accountable leadership and governance; efficient use of hospital financing and maximise innovations and the use of health technologies. Conclusions Effective implementation of healthcare reform remained a challenge for governments in resource-limited settings. Resilient operational, clinical and governance functions of health systems, as well as a motivated and committed health workforce, are important to move healthcare reform processes forward. Political commitments at this juncture might be critical though there need to be a clear demarcation between political and technical engagements. PMID:27650769

An update on enzalutamide in the treatment of prostate cancer

PubMed Central

Haas, Gabriel P.; von Klot, Christoph-A.

2015-01-01

Enzalutamide is an oral androgen receptor inhibitor that targets multiple steps in the androgen receptor signaling pathway. In the randomized phase III AFFIRM study, significant improvements in survival versus placebo were observed when enzalutamide was used as a treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) following prior treatment with docetaxel. Additional benefits included significant delay in time to first skeletal-related event, and improvement in several measures of pain and health-related quality of life. Treatment effects were consistent across all prespecified subgroups. The phase III PREVAIL study evaluated enzalutamide versus placebo in patients with mCRPC who had not received chemotherapy. Enzalutamide significantly decreased the risk of radiographic progression and death. There were also significant improvements in all secondary and prespecified exploratory endpoints, including delayed initiation of chemotherapy, reduction in risk of first skeletal-related event and a high percentage of patients with objective response compared with placebo. Enzalutamide was also studied in hormone naïve patients (as monotherapy) in a small, open-label phase II study in patients with prostate cancer who were eligible for androgen-deprivation therapy. A prostate-specific antigen (PSA) response, defined as ⩾80% decline in PSA level from baseline at week 25, was achieved in 92.5% of patients. Long-term follow up is ongoing. Despite differences between these three trials, enzalutamide displayed a favorable safety profile in all three patient populations. Similar rates of adverse events between the enzalutamide and placebo groups were observed in AFFIRM and PREVAIL, with fatigue, diarrhea, back pain and hot flashes being more common with enzalutamide than with placebo. Hypertension was reported at a higher rate in the enzalutamide group than in the placebo group in PREVAIL. Breast-related disorders associated with enzalutamide treatment were also reported in the Monotherapy trial. Few seizures were reported in any trial. Enzalutamide is being studied in several early disease state populations. PMID:25642291

Limits of 'patient-centredness': valuing contextually specific communication patterns.

PubMed

Mole, Tom B; Begum, Hasna; Cooper-Moss, Nicola; Wheelhouse, Rebecca; MacKeith, Pieter; Sanders, Tom; Wass, Valerie

2016-03-01

Globally, doctor-patient communication is becoming synonymous with high-quality health care in the 21st century. However, what is meant by 'good communication' and whether there is consensus internationally remain unclear. Here, we characterise understandings of 'good communication' in future doctors from medical schools in three contextually contrasting continents. Given locally specific socio-cultural influences, we hypothesised that there would be a lack of global consensus on what constitutes 'good communication'. A standardised two-phase methodology was applied in turn to each of three medical schools in the UK, Egypt and India (n = 107 subjects), respectively, in which students were asked: 'What is good communication?' Phase I involved exploratory focus groups to define preliminary themes (mean number of participants per site: 17). Phase II involved thematic confirmation and expansion in one-to-one semi-structured interviews (mean number of participants per site: 18; mean hours of dialogue captured per site: 55). Findings were triangulated and analysed using grounded theory. The overarching theme that emerged from medical students was that 'good communication' requires adherence to certain 'rules of communication'. A shared rule that doctors must communicate effectively despite perceived disempowerment emerged across all sites. However, contradictory culturally specific rules about communication were identified in relation to three major domains: family; gender, and emotional expression. Egyptian students perceived emotional aspects of Western doctors' communication strikingly negatively, viewing these doctors as problematically cold and unresponsive. Contradictory perceptions of 'good communication' in future doctors are found cross-continentally and may contribute to prevalent cultural misunderstandings in medicine. The lack of global consensus on what defines good communication challenges prescriptively taught Western 'patient-centredness' and questions assumptions about international transferability. Health care professionals must be educated openly about flexible, context-specific communication patterns so that they can avoid cultural incompetence and tailor behaviours in ways that optimise therapeutic outcomes wherever they work around the globe. © 2016 John Wiley & Sons Ltd.

Effects of extracellular polymeric substances on the bioaccumulation of mercury and its toxicity toward the cyanobacterium Microcystis aeruginosa.

PubMed

Chen, Ho-Wen; Huang, Winn-Jung; Wu, Ting-Hsiang; Hon, Chen-Lin

2014-01-01

This investigation examines how extracellular polymeric substances (EPSs) and environmental factors affect the bioaccumulation and toxicity of inorganic mercury (+2 oxidation state, Hg(II)) using a culture of Microcystis aeruginosa, which dominates eutrophic reservoir populations. The identified EPSs were classified as carbohydrates and proteins. Evaluation of the bioaccumulation of Hg(II) in cells by multiple regression analysis reveals that the concentration of EPSs in filtrate, the initial concentration of Hg(II) in medium, and the culture age significantly affected the amount of Hg(II) accumulated. Composition profiles revealed that the concentrations of soluble carbohydrates were significantly higher in Hg(II)-accumulated cells than in the control ones. Preliminary results based on scanning electron microscopic (SEM) map investigations suggest that most of the Hg(II) was accumulated in the cytoplasm (intracellular). Additionally, the effective concentrations (EC50) of Hg(II) that inhibit the growth of M. aeruginosa were 38.6 μg L(-1) in the logarithmic phase and 17.5 μg L(-1) in the stationary phase. As expected, the production of more EPSs in the logarithmic phase typically implies higher EC50 values because EPSs may be regarded as a protective barrier of cells against an external Hg(II) load, enabling them to be less influenced by Hg(II).

Review article: novel oral-targeted therapies in inflammatory bowel disease.

PubMed

White, J R; Phillips, F; Monaghan, T; Fateen, W; Samuel, S; Ghosh, S; Moran, G W

2018-06-01

There is a great unmet clinical need for efficacious, tolerable, economical and orally administrated drugs for the treatment of inflammatory bowel disease (IBD). New therapeutic avenues have become possible including the development of medications that target specific genetic pathways found to be relevant in other immune mediated diseases. To provide an overview of recent clinical trials for new generation oral targeted medications that may have a future role in IBD management. Pubmed and Medline searches were performed up to 1 March 2018 using keywords: "IBD", "UC", "CD", "inflammatory bowel disease" "ulcerative colitis", "Crohn's disease" in combination with "phase", "study", "trial" and "oral". A manual search of the clinical trial register, article reference lists, abstracts from meetings of Digestive Disease Week, United European Gastroenterology Week and ECCO congress were also conducted. In randomised controlled trials primary efficacy endpoints were met for tofacitinib (JAK 1/3 inhibitor-phase III), upadacitinib (JAK 1 inhibitor-phase II) and AJM300 (α4-integrin antagonist-phase II) in ulcerative colitis. Ozanimod (S1P receptor agonist-phase II) also demonstrated clinical remission. For Crohn's disease, filgotinib (JAK1 inhibitor-phase II) met primary endpoints and laquinimod (quinolone-3-carboxide small molecule-phase II) was also efficacious. Trials using mongersen (SMAD7 inhibitor) and vidofludimus (dihydroorotate dehydrogenase inhibitor) have been halted. This is potentially the start of an exciting new era in which multiple therapeutic options are at the disposal of physicians to treat IBD on an individualised basis. Head-to-head studies with existing treatments and longer term safety data are needed for this to be possible. © 2018 John Wiley & Sons Ltd.

Variance of foot biomechanical parameters across age groups for the elderly people in Romania

NASA Astrophysics Data System (ADS)

Deselnicu, D. C.; Vasilescu, A. M.; Militaru, G.

2017-10-01

The paper presents the results of a fieldwork study conducted in order to analyze major causal factors that influence the foot deformities and pathologies of elderly women in Romania. The study has an exploratory and descriptive nature and uses quantitative methodology. The sample consisted of 100 elderly women from Romania, ranging from 55 to over 75 years of age. The collected data was analyzed on multiple dimensions using a statistic analysis software program. The analysis of variance demonstrated significant differences across age groups in terms of several biomechanical parameters such as travel speed, toe off phase and support phase in the case of elderly women.

The case for introducing pre-registered confirmatory pharmacological pre-clinical studies.

PubMed

Kiwanuka, Olivia; Bellander, Bo-Michael; Hånell, Anders

2018-05-01

When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

Ethical, legal, and social implications (ELSI) of microdose clinical trials.

PubMed

Kurihara, Chieko

2011-06-19

A "microdose clinical trial" (microdosing) is one kind of early phase exploratory clinical trial, administering the compound at doses estimated to have no pharmacological or toxicological effects, aimed at screening candidates for further clinical development. This article's objective is to clarify the ethical, legal, and social implications (ELSI) of such an exploratory minimum-risk human trial. The definition and non-clinical study requirements for microdosing have been harmonized among the European Union (EU), United States (US), and Japan. Being conducted according to these regulations, microdosing seems to be ethically well justified in terms of respect for persons, beneficence, justice, human dignity, and animal welfare. Three big projects have been demonstrating the predictability of therapeutic dose pharmacokinetics from microdosing. The article offers suggestions as how microdosing can become a more useful and socially accepted strategy. Copyright © 2011 Elsevier B.V. All rights reserved.

DSM-5 section III personality traits and section II personality disorders in a Flemish community sample.

PubMed

Bastiaens, Tim; Smits, Dirk; De Hert, Marc; Vanwalleghem, Dominique; Claes, Laurence

2016-04-30

The Personality Inventory for DSM-5 (PID-5; Krueger et al., 2012) is a dimensional self-report questionnaire designed to measure personality pathology according to the criterion B of the DSM-5 Section III personality model. In the current issue of DSM, this dimensional Section III personality model co-exists with the Section II categorical personality model derived from DSM-IV-TR. Therefore, investigation of the inter-relatedness of both models across populations and languages is warranted. In this study, we first examined the factor structure and reliability of the PID-5 in a Flemish community sample (N=509) by means of exploratory structural equation modeling and alpha coefficients. Next, we investigated the predictive ability of section III personality traits in relation to section II personality disorders through correlations and stepwise regression analyses. Results revealed a five factor solution for the PID-5, with adequate reliability of the facet scales. The variance in Section II personality disorders could be predicted by their theoretically comprising Section III personality traits, but additional Section III personality traits augmented this prediction. Based on current results, we discuss the Section II personality disorder conceptualization and the Section III personality disorder operationalization. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Efficacy of repetitive transcranial magnetic stimulation with quetiapine in treating bipolar II depression: a randomized, double-blinded, control study.

PubMed

Hu, Shao-Hua; Lai, Jian-Bo; Xu, Dong-Rong; Qi, Hong-Li; Peterson, Bradley S; Bao, Ai-Min; Hu, Chan-Chan; Huang, Man-Li; Chen, Jing-Kai; Wei, Ning; Hu, Jian-Bo; Li, Shu-Lan; Zhou, Wei-Hua; Xu, Wei-Juan; Xu, Yi

2016-07-27

The clinical and cognitive responses to repetitive transcranial magnetic stimulation (rTMS) in bipolar II depressed patients remain unclear. In this study, thirty-eight bipolar II depressed patients were randomly assigned into three groups: (i) left high-frequency (n = 12), (ii) right low-frequency (n = 13), (iii) sham stimulation (n = 13), and underwent four-week rTMS with quetiapine concomitantly. Clinical efficacy was evaluated at baseline and weekly intervals using the 17-item Hamilton Depression Rating Scale (HDRS-17) and Montgomery-Asberg Depression Rating Scale (MADRS). Cognitive functioning was assessed before and after the study with the Wisconsin Card Sorting Test (WCST), Stroop Word-Color Interference Test (Stroop), and Trail Making Test (TMT). Thirty-five patients were included in the final analysis. Overall, the mean scores of both the HDRS-17 and the MADRS significantly decreased over the 4-week trial, which did not differ among the three groups. Exploratory analyses revealed no differences in factor scores of HDRS-17s, or in response or remission rates. Scores of WCST, Stroop, or TMT did not differ across the three groups. These findings indicated active rTMS combined with quetiapine was not superior to quetiapine monotherapy in improving depressive symptoms or cognitive performance in patients with bipolar II depression.

75 FR 62530 - Eagle Creek Hydro Power, LLC; Laredo Ridge Wind, LLC; RRI Energy West, Inc.; Goshen Phase II LLC...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-12

...; EG10-52-000; EG10-53-000; EG10- 54-000; EG10-55-000; EG10-56-000] Eagle Creek Hydro Power, LLC; Laredo Ridge Wind, LLC; RRI Energy West, Inc.; Goshen Phase II LLC; Solar Partners I, LLC; Solar Partners II, LLC; Solar Partners VIII, LLC; Notice of Effectiveness of Exempt Wholesale Generator Status October 1...

Project 1946: Phase II

DTIC Science & Technology

2010-07-01

History (Project 1946 - Phase II),” for the National Intelligence Council. The views, opinions, and findings should not be construed as representing...29 Section 1: Senior Leadership  Foreign Assistance  Officer Corps  Saddam‘s Personality ...45 Section 3: Personal Interactions with Saddam  Senior Leadership

Magnetic sensor for nondestructive evaluation of deteriorated prestressing strand : phase II.

DOT National Transportation Integrated Search

2011-08-01

This report gives an account of the execution and achievements in Phase II of the project completed through August 2011. The main objective of this project is to advance the practical development of a nondestructive testing and evaluation method usin...

New Round of Studies Begin in Phase 0/I/II Cancer Prevention Clinical Trials Program | Division of Cancer Prevention

Cancer.gov

The NCI Division of Cancer Prevention’s Phase 0/I/II Cancer Prevention Clinical Trials Program, also known as the Consortia for Early Phase Prevention Trials, is beginning a new round of studies in the effort toward systematic early clinical development of promising preventive agents for people at increased risk of developing cancer. |

Chronology and pyroclastic stratigraphy of the May 18, 1980, eruption of Mount St. Helens, Washington

NASA Technical Reports Server (NTRS)

Criswell, C. William

1987-01-01

The eruption of Mount St. Helens on May 18, 1980 can be subdivided into six phases: the paroxysmal phase I, the early Plinian phase II, the early ash flow phase III, the climactic phase IV, the late ash flow phase V, and phase VI, the activity of which consisted of a low-energy ash plume. These phases are correlated with stratigraphic subunits of ash-fall tephra and pyroclastic flow deposits. Sustained vertical discharge of phase II produced evolved dacite with high S/Cl ratios. Ash flow activity of phase III is attributed to decreases in gas content, indicated by reduced S/Cl ratios and increased clast density of the less evolved gray pumice. Climactic events are attributed to vent clearing and exhaustion of the evolved dacite.

Expendable Air Vehicles/High Altitude Balloon Technology. Phase 1.

DTIC Science & Technology

1991-08-02

CHR/91 -2750 I I I I I THIS PAGE INTENTIONALLY LEFT BLANK 3 I I U I I I I I I I I I CHR/91 -2750 PREFACE The work described in this Phase II SBIR...Final Technical Report is the implementation of a capability which Coleman Research Corporation demon- strated during a Phase I SBIR (contract number...CRC) has developed a Balloon Drift Pattern Simulation 1BDPS). CRC developed this simulation software for digital computers as a product of a Phase II

Application of a Network Perspective to DoD Weapon System Acquisition: An Exploratory Study

DTIC Science & Technology

2007-04-30

the course of action, and prepare for the Technology Development phase. As one could guess based on the description of...include allocating requirements and developing a design, testing the design, and preparing for production and fielding of the system. This analysis...Management and Budget (OMB) prepare the defense portion of the President’s Budget. Even though Congress normally appropriates money for only

NATO Standardization and Licensing Policy - Exploratory Phase. Volume 2. Main Report

DTIC Science & Technology

1976-11-30

issued under this section, every person who engages in the business of manufacturing, exporting, or importing arms, ammunition, or implements of... Wiliiam C. Pettijohn, Consultant Arthur Tyler Port, Consultant George M. Sr.ead, Jr. and Hoagland, MacLachlan & Co., Inc., Subcontractor 8...support in obtaining interviews with busy officials. The views and judgments expressed in this report are those of the authors and do not

A FUEL-RICH PRECOMBUSTOR. FIELD EVALUATION OF LOW-EMISSION COAL BURNER TECHNOLOGY ON UTILITY BOILERS - VOLUME IV. ALTERNATE CON- CEPTS FOR SOX, NOX, AND PARTICULATE EMISSIONS CONTROL FROM

EPA Science Inventory

The report gives results a study of the use of precombustors for the simultaneous control of S02, NOx, and ash emissions from coal combustion. In Phase 1, exploratory testing was conducted on a small pilot scale--293 kW (million Btu/hr)-pulverized-coal-fired precombustor to ident...

NATO Standardization and Licensing Policy-Exploratory Phase. Volume 3. Supplement

DTIC Science & Technology

1976-11-30

Aerospatiale will perform at least half the production of this aircraft.* The concept involves a relatively light- weight advanced interceptor with...a ratio of total thrust to takeoff gross weight of about unity. The technology of the aircraft calls for the use of carbon fiber in selected...presenting a system with operating temperatures, pressure ratios, and thrust-to- weight ratios roughly comparable to U.S. technology. The

Probiotic helminth administration in relapsing-remitting multiple sclerosis: a phase 1 study.

PubMed

Fleming, J O; Isaak, A; Lee, J E; Luzzio, C C; Carrithers, M D; Cook, T D; Field, A S; Boland, J; Fabry, Z

2011-06-01

Probiotic treatment strategy based on the hygiene hypothesis, such as administration of ova from the non-pathogenic helminth, Trichuris suis, (TSO) has proven safe and effective in autoimmune inflammatory bowel disease. To study the safety and effects of TSO in a second autoimmune disease, multiple sclerosis (MS), we conducted the phase 1 Helminth-induced Immunomodulatory Therapy (HINT 1) study. Five subjects with newly diagnosed, treatment-naive relapsing-remitting multiple sclerosis (RRMS) were given 2500 TSO orally every 2 weeks for 3 months in a baseline versus treatment control exploratory trial. The mean number of new gadolinium-enhancing magnetic resonance imaging (MRI) lesions (n-Gd+) fell from 6.6 at baseline to 2.0 at the end of TSO administration, and 2 months after TSO was discontinued, the mean number of n-Gd+ rose to 5.8. No significant adverse effects were observed. In preliminary immunological investigations, increases in the serum level of the cytokines IL-4 and IL-10 were noted in four of the five subjects. TSO was well tolerated in the first human study of this novel probiotic in RRMS, and favorable trends were observed in exploratory MRI and immunological assessments. Further investigations will be required to fully explore the safety, effects, and mechanism of action of this immunomodulatory treatment.

Healthcare managers' decision making: findings of a small scale exploratory study.

PubMed

Macdonald, Jackie; Bath, Peter A; Booth, Andrew

2008-12-01

Managers who work in publicly funded healthcare organizations are an understudied group. Some of the influences on their decisions may be unique to healthcare. This study considers how to integrate research knowledge effectively into healthcare managers' decision making, and how to manage and integrate information that will include community data. This first phase in a two-phase mixed methods research study used a qualitative, multiple case studies design. Nineteen semi-structured interviews were undertaken using the critical incident technique. Interview transcripts were analysed using the NatCen Framework. One theme represented ;information and decisions'. Cases were determined to involve complex multi-level, multi-situational decisions with participants in practical rather than ceremonial work roles. Most considered organizational knowledge in the first two decision phases and external knowledge, including research, in the third phase. All participants engaged in satisficing to some degree.

[Cotard's syndrome. Different treatment strategies according to subclassification].

PubMed

Madani, Y; Sabbe, B G C

2007-01-01

After performing an exploratory factor analysis, Berrios & Luque (1995) identified three subcategories in the Cotard's syndrome: Cotard type I, Cotard type II and Cotard type psychotic depression. The article, which is based on two case studies and an examination of the relevant literature since 1995, explores whether there are different treatment strategies for Cotard type I and the Cotard type psychotic depression. For the Cotard type psychotic depression, electroconvulsive therapy proves to be an effective method of treatment. For Cotard type I, antipsychotic therapy seems to be sufficient.

Can pets function as family members?

PubMed

Cohen, Susan Phillips

2002-10-01

This exploratory study investigated how clients of a large urban veterinary center viewed the role of their pet in the famil and how they compared this role to that of humans. In Phase 1, randomly selected clients (N = 201) completed a questionnaire containing scales delineating family relationships and pet attachment. Being either a man or a college graduate was associated with lesser feelings of psychological kinship and intimacy, both with pets and people. Neither living with a partner norhaving a child affected the strength of pet relationships. In Phase 2, 16 participants from Phase I completed a social network instrument and answered questions about family roles and boundaries. Thirteen of the 16 respondents said that there were circumstances in which they would give a scarce drug to their pet in preference to a person outside the family.

A green separation strategy for neodymium (III) from cobalt (II) and nickel (II) using an ionic liquid-based aqueous two-phase system.

PubMed

Chen, Yuehua; Wang, Huiyong; Pei, Yuanchao; Wang, Jianji

2018-05-15

It is significant to develop sustainable strategies for the selective separation of rare earth from transition metals from fundamental and practical viewpoint. In this work, an environmentally friendly solvent extraction approach has been developed to selectively separate neodymium (III) from cobalt (II) and nickel (II) by using an ionic liquid-based aqueous two phase system (IL-ATPS). For this purpose, a hydrophilic ionic liquid (IL) tetrabutylphosphonate nitrate ([P 4444 ][NO 3 ]) was prepared and used for the formation of an ATPS with NaNO 3 . Binodal curves of the ATPSs have been determined for the design of extraction process. The extraction parameters such as contact time, aqueous phase pH, content of phase-formation components of NaNO 3 and the ionic liquid have been investigated systematically. It is shown that under optimal conditions, the extraction efficiency of neodymium (III) is as high as 99.7%, and neodymium (III) can be selectively separated from cobalt (II) and nickel (II) with a separation factor of 10 3 . After extraction, neodymium (III) can be stripped from the IL-rich phase by using dilute aqueous sodium oxalate, and the ILs can be quantitatively recovered and reused in the next extraction process. Since [P 4444 ][NO 3 ] works as one of the components of the ATPS and the extractant for the neodymium, no organic diluent, extra etractant and fluorinated ILs are used in the separation process. Thus, the strategy described here shows potential in green separation of neodymium from cobalt and nickel by using simple IL-based aqueous two-phase system. Copyright © 2018 Elsevier B.V. All rights reserved.

The Design of Phase II Clinical Trials Testing Cancer Therapeutics: Consensus Recommendations from the Clinical Trial Design Task Force of the National Cancer Institute Investigational Drug Steering Committee

PubMed Central

Seymour, Lesley; Ivy, S. Percy; Sargent, Daniel; Spriggs, David; Baker, Laurence; Rubinstein, Larry; Ratain, Mark J; Le Blanc, Michael; Stewart, David; Crowley, John; Groshen, Susan; Humphrey, Jeffrey S; West, Pamela; Berry, Donald

2010-01-01

The optimal design of phase II studies continues to be the subject of vigorous debate, especially with regards to studies of newer molecularly targeted agents. The observations that many new therapeutics ‘fail’ in definitive phase III studies, coupled with the numbers of new agents to be tested as well as the increasing costs and complexity of clinical trials further emphasizes the critical importance of robust and efficient phase II design. The Clinical Trial Design Task Force(CTD-TF)of the NCI Investigational Drug Steering Committee (IDSC) has published a series of discussion papers on Phase II trial design in Clinical Cancer Research. The IDSC has developed formal recommendations regarding aspects of phase II trial design which are the subject of frequent debate such as endpoints(response vs. progression free survival), randomization(single arm designs vs. randomization), inclusion of biomarkers, biomarker based patient enrichment strategies, and statistical design(e.g. two stage designs vs. multiple-group adaptive designs). While these recommendations in general encourage the use of progression-free survival as the primary endpoint, the use of randomization, the inclusion of biomarkers and the incorporation of newer designs, we acknowledge that objective response as an endpoint, and single arm designs, remain relevant in certain situations. The design of any clinical trial should always be carefully evaluated and justified based on the characteristic specific to the situation. PMID:20215557

Effects of phase II cardiac rehabilitation on job stress and health-related quality of life after return to work in middle-aged patients with acute myocardial infarction.

PubMed

Yonezawa, Ryusuke; Masuda, Takashi; Matsunaga, Atsuhiko; Takahashi, Yumi; Saitoh, Masakazu; Ishii, Akira; Kutsuna, Toshiki; Matsumoto, Takuya; Yamamoto, Kazuya; Aiba, Naoko; Hara, Miyako; Izumi, Tohru

2009-05-01

The aim of the present study was to clarify the effects of phase II cardiac rehabilitation (CR) on job stress and health-related quality of life (HRQOL) after return to work in middle-aged patients with acute myocardial infarction (AMI). A total of 109 middle-aged outpatients (57 +/- 7 years) who completed a phase I CR program after AMI were enrolled, 72 of whom participated in a phase II CR program for 5 months after hospital discharge (CR group) and 37 who discontinued the phase II CR program after the discharge (non-CR group). Job stress was assessed at 6 months after the AMI using a brief job stress questionnaire containing questions related to job stressors, worksite support, level of satisfaction with work or daily life, and psychological distress. HRQOL was assessed using the short-form 36-item health survey (SF-36) at hospital discharge and at 3 and 6 months after the AMI. There were no significant differences in clinical and occupational characteristics between the CR and non-CR groups. The CR group patients exhibited significantly better results for job stressors and psychological distress and higher SF-36 scores at 6 months after the AMI, as compared with those in the non-CR group. These findings suggest that discontinuing a phase II CR program induced chronic psychosocial stress after return to work in these middle-aged post-AMI patients.

Community shift of biofilms developed in a full-scale drinking water distribution system switching from different water sources.

PubMed

Li, Weiying; Wang, Feng; Zhang, Junpeng; Qiao, Yu; Xu, Chen; Liu, Yao; Qian, Lin; Li, Wenming; Dong, Bingzhi

2016-02-15

The bacterial community of biofilms in drinking water distribution systems (DWDS) with various water sources has been rarely reported. In this research, biofilms were sampled at three points (A, B, and C) during the river water source phase (phase I), the interim period (phase II) and the reservoir water source phase (phase III), and the biofilm community was determined using the 454-pyrosequencing method. Results showed that microbial diversity declined in phase II but increased in phase III. The primary phylum was Proteobacteria during three phases, while the dominant class at points A and B was Betaproteobacteria (>49%) during all phases, but that changed to Holophagae in phase II (62.7%) and Actinobacteria in phase III (35.6%) for point C, which was closely related to its water quality. More remarkable community shift was found at the genus level. In addition, analysis results showed that water quality could significantly affect microbial diversity together, while the nutrient composition (e.g. C/N ration) of the water environment might determine the microbial community. Furthermore, Mycobacterium spp. and Pseudomonas spp. were detected in the biofilm, which should give rise to attention. This study revealed that water source switching produced substantial impact on the biofilm community. Copyright © 2015 Elsevier B.V. All rights reserved.

Elastic properties of crystalline and liquid gallium at high pressures

NASA Astrophysics Data System (ADS)

Lyapin, A. G.; Gromnitskaya, E. L.; Yagafarov, O. F.; Stal'Gorova, O. V.; Brazhkin, V. V.

2008-11-01

The elastic properties of gallium, such as the bulk modulus B, the shear modulus G, and the Poisson’s ratio σ, are investigated and the relative change in the volume is determined in the stability regions of the Ga I, Ga II, and liquid phases at pressures of up to 1.7 GPa. The observed lines of the Ga I-Ga II phase transition and the melting curves of the Ga I and Ga II phases are in good agreement with the known phase diagram of gallium; in this case, the coordinates of the Ga I-Ga II-melt triple point are determined to be 1.24 ± 0.40 GPa and 277 ± 2 K. It is shown that the Ga I-Ga II phase transition is accompanied by a considerable decrease in the moduli B (by 30%) and G (by 55%) and an increase in the density by 5.7%. The Poisson’s ratio exhibits a jump from typically covalent values of approximately 0.22-0.25 to values of approximately 0.32-0.33, which are characteristic of metals. The observed behavior of the elastic characteristics is described in the framework of the model of the phase transition from a “quasi-molecular” (partially covalent) metal state to a “normal” metal state. An increase in the Poisson’s ratio in the Ga I phase from 0.22 to 0.25 with an increase in the pressure can be interpreted as a decrease in the degree of covalence, i.e., the degree of spatial anisotropy of the electron density along the bonds, whereas the large value of the pressure derivative of the bulk modulus (equal to approximately 8) observed up to the transition to the Ga II phase or the melt is associated not only with the quasicovalent nature of the Ga I phase but also with the structural features. In view of the presence of seven neighbors for each gallium atom in the Ga I phase, the gallium lattice can be treated as a structure intermediate between typical open-packed and close-packed structures. Premelting effects, such as a flattening of the isothermal dependence of the shear modulus G( p) with increasing pressure and an increase in the slope of the isobaric dependences G( T) with increasing temperature, are revealed in the vicinity of the melting curve. The bulk modulus of liquid gallium near the melting curve proves to be rather close to the corresponding values for the normal metal Ga II.

Measuring sport experiences in children and youth to better understand the impact of sport on health and positive youth development: designing a brief measure for population health surveys.

PubMed

Cairney, John; Clark, Heather J; Kwan, Matthew Y W; Bruner, Mark; Tamminen, Katherine

2018-04-03

Despite the proliferation of studies examining youth sport participation, there are significant gaps in knowledge regarding the impact of youth sport participation on health and development. These gaps are not new, but have persisted due to limitations with how sport participation is measured. Much of the research to date has measured sport participation as binary (yes/no) or count measures. This has been especially true in survey-based research. Yet, at the same time, research has investigated youths' experiences in sport such as the influence of coaches, teammates, and parents. The ability to measure these experiences is constrained by the need to use a number of measures along with gaps in the content covered in existing measures. We propose to develop and test the Sport Experiences Measure: Children and Youth (SEM:CY) as a population survey-based measure that captures the salient aspects of youths' experience in sport. The SEM:CY will be developed and tested across three phases. Phase I includes qualitative research with members of the sport community and engagement with an expert group to generate and obtain feedback on the initial item pool. In Phase II will recruit two consecutive samples of students from schools to complete the draft measure. Analysis will focus on assessing the items and factor structure of the measure. Factor structure will be assessed first with exploratory factor analysis and then confirmatory factor analysis. In phase III we will test the association between the SEM:CY with a measure of perceived competence, sport anxiety, and positive youth development to assess construct validity. We will also examine whether the structure of the measure varies by age or gender. The SEM:CY measure will provide a meaningful contribution to the measurement and understanding of youth sport participation. The SEM:CY can be used as a stand-alone measure to understand youth experiences in sport programs, or in combination with other health and development measures to better understand how youth sport can contribute to both positive and negative outcomes.

Development and psychometric evaluation of the Personal Growth Initiative Scale-II.

PubMed

Robitschek, Christine; Ashton, Matthew W; Spering, Cynthia C; Geiger, Nathaniel; Byers, Danielle; Schotts, G Christian; Thoen, Megan A

2012-04-01

The original Personal Growth Initiative Scale (PGIS; Robitschek, 1998) was unidimensional, despite theory identifying multiple components (e.g., cognition and behavior) of personal growth initiative (PGI). The present research developed a multidimensional measure of the complex process of PGI, while retaining the brief and psychometrically sound properties of the original scale. Study 1 focused on scale development, including theoretical derivation of items, assessing factor structure, reducing number of items, and refining the scale length using samples of college students. Study 2 consisted of confirmatory factor analysis with 3 independent samples of college students and community members. Lastly, Study 3 assessed test-retest reliability over 1-, 2-, 4-, and 6-week periods and tests of concurrent and discriminant validity using samples of college students. The final measure, the Personal Growth Initiative Scale-II (PGIS-II), includes 4 subscales: Readiness for Change, Planfulness, Using Resources, and Intentional Behavior. These studies provide exploratory and confirmatory evidence for the 4-factor structure, strong internal consistency for the subscales and overall score across samples, acceptable temporal stability at all assessed intervals, and concurrent and discriminant validity of the PGIS-II. Future directions for research and clinical practice are discussed.

Project NOAH: Regulating modern sea-level rise. Phase II: Jerusalem Underground

NASA Astrophysics Data System (ADS)

Newman, Walter S.; Fairbridge, Rhodes W.

This proposal builds a high-speed inter-urban express between Jerusalem and Tel Aviv, generates 1500 megawatts of hydroelectric energy, curtails littoral erosion, builds a port along the Israeli Mediterranean coast and demands peaceful cooperation on both sides of the Jordan River. Phase II represents a pilot project demonstrating the feasibility of continuing to regulate world sea-level by a new series of water regulation schemes. Phase I previously described all those projects already completed or underway which have inadvertently and/or unintentionally served the purpose of sea-level regulation. These forms of Phase I sea-level regulation include large and small reservoirs, irrigation projects, water infiltration schemes, farm ponds, and swimming and reflecting pools. All these water storage projects have already exercised a very appreciable brake on 20th century sea-level rise. Phase II outlines a high-visibility proposal which will serve to illustrate the viability of “Project NOAH”.

Characterization of pH dependent Mn(II) oxidation strategies and formation of a bixbyite-like phase by Mesorhizobium australicum T-G1

PubMed Central

Bohu, Tsing; Santelli, Cara M.; Akob, Denise M.; Neu, Thomas R.; Ciobota, Valerian; Rösch, Petra; Popp, Jürgen; Nietzsche, Sándor; Küsel, Kirsten

2015-01-01

Despite the ubiquity of Mn oxides in natural environments, there are only a few observations of biological Mn(II) oxidation at pH < 6. The lack of low pH Mn-oxidizing bacteria (MOB) isolates limits our understanding of how pH influences biological Mn(II) oxidation in extreme environments. Here, we report that a novel MOB isolate, Mesorhizobium australicum strain T-G1, isolated from an acidic and metalliferous uranium mining area, can oxidize Mn(II) at both acidic and neutral pH using different enzymatic pathways. X-ray diffraction, Raman spectroscopy, and scanning electron microscopy with energy dispersive X-ray spectroscopy revealed that T-G1 initiated bixbyite-like Mn oxide formation at pH 5.5 which coincided with multi-copper oxidase expression from early exponential phase to late stationary phase. In contrast, reactive oxygen species (ROS), particularly superoxide, appeared to be more important for T-G1 mediated Mn(II) oxidation at neutral pH. ROS was produced in parallel with the occurrence of Mn(II) oxidation at pH 7.2 from early stationary phase. Solid phase Mn oxides did not precipitate, which is consistent with the presence of a high amount of H2O2 and lower activity of catalase in the liquid culture at pH 7.2. Our results show that M. australicum T-G1, an acid tolerant MOB, can initiate Mn(II) oxidation by varying its oxidation mechanisms depending on the pH and may play an important role in low pH manganese biogeochemical cycling. PMID:26236307

Life cycle and economic efficiency analysis phase II : durable pavement markings.

DOT National Transportation Integrated Search

2011-04-01

This report details the Phase II analysis of the life cycle and economic efficiency of inlaid tape : and thermoplastic. Waterborne paint was included as a non-durable for comparison purposes : only. In order to find the most economical product for sp...

77 FR 19660 - Combined Notice of Filings #1

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-02

.... Applicants: Goshen Phase II LLC, Ridgeline Alternative Energy, LLC. Description: Joint Application for Authorization under Section 203 of the Federal Power Act of Goshen Phase II and Ridgeline Alternative Energy... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings 1 Take notice...

Field testing of hand-held infrared thermography, phase II TPF-5(247) : final report.

DOT National Transportation Integrated Search

2016-05-01

This report is the second of two volumes that document results from the pooled fund study TPF-5 (247), Development of : Handheld Infrared Thermography, Phase II. The interim report (volume I) studied the implementation of handheld thermography : by p...

Reassessing Phase II Heart Failure Clinical Trials: Consensus Recommendations

PubMed Central

Butler, Javed; Hamo, Carine E.; Udelson, James E.; O’Connor, Christopher; Sabbah, Hani N.; Metra, Marco; Shah, Sanjiv J.; Kitzman, Dalane W.; Teerlink, John; Bernstein, Harold S.; Brooks, Gabriel; Depre, Christophe; DeSouza, Mary M.; Dinh, Wilfried; Donovan, Mark; Frische-Danielson, Regina; Frost, Robert J.; Garza, Dahlia; Gohring, Udo-Michael; Hellawell, Jennifer; Hsia, Judith; Ishihara, Shiro; Kay-Mugford, Patricia; Koglin, Joerg; Kozinn, Marc; Larson, Christopher J.; Mayo, Martha; Gan, Li-Ming; Mugnier, Pierrre; Mushonga, Sekayi; Roessig, Lothar; Russo, Cesare; Salsali, Afshin; Satler, Carol; Shi, Victor; Ticho, Barry; van der Laan, Michael; Yancy, Clyde; Stockbridge, Norman; Gheorghiade, Mihai

2017-01-01

The increasing burden and the continued suboptimal outcomes for patients with heart failure underlines the importance of continued research to develop novel therapeutics for this disorder. This can only be accomplished with successful translation of basic science discoveries into direct human application through effective clinical trial design and execution that results in a substantially improved clinical course and outcomes. In this respect, phase II clinical trials play a pivotal role in determining which of the multitude of potential basic science discoveries should move to the large and expansive registration trials in humans. A critical examination of the phase II trials in heart failure reveals multiple shortcomings in their concept, design, execution, and interpretation. To further a dialogue regarding the challenges and potential for improvement and the role of phase II trials in patients with heart failure, the Food and Drug Administration facilitated a meeting on October 17th 2016 represented by clinicians, researchers, industry members, and regulators. This document summarizes the discussion from this meeting and provides key recommendations for future directions. PMID:28356300

Malignant pleural mesothelioma: a phase II trial with docetaxel.

PubMed

Vorobiof, D A; Rapoport, B L; Chasen, M R; Abratt, R P; Cronje, N; Fourie, L; McMichael, G; Hacking, D

2002-03-01

Current cytotoxic therapy has been of limited benefit to patients with malignant pleural mesothelioma. Single agent chemotherapy has been extensively evaluated in small series of phase II clinical trials, with disappointing responses. Docetaxel, an effective taxane in the treatment of advanced breast cancer and non-small-cell lung cancer, was administered intravenously at a dose of 100 mg/m2 every 3 weeks to 30 chemotherapy naive patients with malignant pleural mesothelioma in a prospective multi-institutional phase II clinical trial. An objective response rate (partial responses) of 10% was documented. Additionally, 21% of the patients had minor responses (intention-to-treat analysis). Three patients died within 2 weeks post-first cycle of therapy, although only one patient's death was directly attributed to the investigational drug, whilst in the majority of the patients, manageable and treatable toxicities were encountered. In this phase II clinical trial, docetaxel proved to be mildly effective in the treatment of patients with malignant pleural mesothelioma.

Soluble Mesothelin Related Peptide (SMRP) and Osteopontin (OPN) as Early Detection Markers for Malignant Mesothelioma (MM) — EDRN Public Portal

Cancer.gov

Phase I: - Identification and assemblage of representative cohorts of individuals with MM, no malignancies but increased risk for MM due to asbestos exposure, and (optionally) lung malignancies other than MM Phase II (A) - Determine the sensitivity and specificity of SMRP and OPN in distinguishing individuals with a clinical diagnosis of malignant mesothelioma from individuals who are asbestos-exposed but without a clinical diagnosis of malignant mesothelioma. Phase II (B) – Determine the comparability of analyte values across contributing centers and determine covariates that influence analyte levels Phase II (C) – Determine the sensitivity and specificity of SMRP and OPN, alone and in combination, in distinguishing individuals with MM from those without. Phase III. Determine the sensitivity and specificity of SMRP and OPN in distinguishing individuals who would subsequently develop malignant mesothelioma from matched individuals who did not subsequently develop malignant mesothelioma. Phase IV. Determine the sensitivity and specificity of SMRP and OPN in other populations of interest.

Optical constants of solid methane and ethane from 10,000 to 450/cm. [in outer planets atmospheres

NASA Technical Reports Server (NTRS)

Pearl, J.; Ngoh, M.; Ospina, M.; Khanna, R.

1991-01-01

Near- and mid-IR spectra of thin films of crystalling phase I and phase II C2H6 are presented using a combined least squares and Kramers-Kronig analysis. Complex refractive indices derived from these data are also presented. To obtain material in phase I, samples are annealed at 33 K for about 30 min; phase II is obtained by recooling below the transition temperature of 20.4 K. The derived optical parameters are shown. The infrared spectrum of phase I CH4 exhibits broad structureless absorptions at about 1300 and 2600/cm. On cooling the sample below 20.4 K (phase II), the absorptions are sharpened, and each band develops fine structure. The present results and those of Roux et al. (1979) are compared. The agreement with the real parts is found to be excellent; given the difference in resolution, the agreement with the imaginary parts is also good.

Nitrous oxide emissions in a membrane bioreactor treating saline wastewater contaminated by hydrocarbons.

PubMed

Mannina, Giorgio; Cosenza, Alida; Di Trapani, Daniele; Laudicina, Vito Armando; Morici, Claudia; Ødegaard, Hallvard

2016-11-01

The joint effect of wastewater salinity and hydrocarbons on nitrous oxide emission was investigated. The membrane bioreactor pilot plant was operated with two phases: i. biomass acclimation by increasing salinity from 10gNaClL(-1) to 20gNaClL(-1) (Phase I); ii. hydrocarbons dosing at 20mgL(-1) with a constant salt concentration of 20gNaClL(-1) (Phase II). The Phase I revealed a relationship between nitrous oxide emissions and salinity. During the end of the Phase I, the activity of nitrifiers started to recover, indicating a partial acclimatization. During the Phase II, the hydrocarbon shock induced a temporary inhibition of the biomass with the suppression of nitrous oxide emissions. The results revealed that the oxic tank was the major source of nitrous oxide emission, likely due to the gas stripping by aeration. The joint effect of salinity and hydrocarbons was found to be crucial for the production of nitrous oxide. Copyright © 2016 Elsevier Ltd. All rights reserved.

The history of couple therapy: a millennial review.

PubMed

Gurman, Alan S; Fraenkel, Peter

2002-01-01

In this article, we review the major conceptual and clinical influences and trends in the history of couple therapy to date, and also chronicle the history of research on couple therapy. The evolving patterns in theory and practice are reviewed as having progressed through four distinctive phases: Phase I--Atheoretical Marriage Counseling Formation (1930-1963); Phase II--Psychoanalytic Experimentation (1931-1966); Phase III--Family Therapy Incorporation (1963-1985); and Phase IV--Refinement, Extension, Diversification, and Integration (1986-present). The history of research in the field is described as having passed through three phases: Phase I--A Technique in Search of Some Data (1930-1974), Phase II--Irrational(?) Exuberance (1975-1992), and Phase III--Caution and Extension (1993-present). The article concludes with the identification of Four Great Historical Ironies in the History of Couple Therapy.

Exploratory analysis of textual data from the Mother and Child Handbook using the text-mining method: Relationships with maternal traits and post-partum depression.

PubMed

Matsuda, Yoshio; Manaka, Tomoko; Kobayashi, Makiko; Sato, Shuhei; Ohwada, Michitaka

2016-06-01

The aim of the present study was to examine the possibility of screening apprehensive pregnant women and mothers at risk for post-partum depression from an analysis of the textual data in the Mother and Child Handbook by using the text-mining method. Uncomplicated pregnant women (n = 58) were divided into two groups according to State-Trait Anxiety Inventory grade (high trait [group I, n = 21] and low trait [group II, n = 37]) or Edinburgh Postnatal Depression Scale score (high score [group III, n = 15] and low score [group IV, n = 43]). An exploratory analysis of the textual data from the Maternal and Child Handbook was conducted using the text-mining method with the Word Miner software program. A comparison of the 'structure elements' was made between the two groups. The number of structure elements extracted by separated words from text data was 20 004 and the number of structure elements with a threshold of 2 or more as an initial value was 1168. Fifteen key words related to maternal anxiety, and six key words related to post-partum depression were extracted. The text-mining method is useful for the exploratory analysis of textual data obtained from pregnant woman, and this screening method has been suggested to be useful for apprehensive pregnant women and mothers at risk for post-partum depression. © 2016 Japan Society of Obstetrics and Gynecology.

NOx Emissions Characteristics and Correlation Equations of Two P and W's Axially Staged Sector Combustors Developed Under NASA Environmentally Responsible Aviation (ERA) Project

NASA Technical Reports Server (NTRS)

He, Zhuohui J.

2017-01-01

Two P&W (Pratt & Whitney)'s axially staged sector combustors have been developed under NASA's Environmentally Responsible Aviation (ERA) project. One combustor was developed under ERA Phase I, and the other was developed under ERA Phase II. Nitrogen oxides (NOx) emissions characteristics and correlation equations for these two sector combustors are reported in this article. The Phase I design was to optimize the NOx emissions reduction potential, while the Phase II design was more practical and robust. Multiple injection points and fuel staging strategies are used in the combustor design. Pilot-stage injectors are located on the front dome plate of the combustor, and main-stage injectors are positioned on the top and bottom (Phase I) or on the top only (Phase II) of the combustor liners downstream. Low power configuration uses only pilot-stage injectors. Main-stage injectors are added to high power configuration to help distribute fuel more evenly and achieve lean burn throughout the combustor yielding very low NOx emissions. The ICAO (International Civil Aviation Organization) landing-takeoff NOx emissions are verified to be 88 percent (Phase I) and 76 percent (Phase II) under the ICAO CAEP/6 (Committee on Aviation Environmental Protection 6th Meeting) standard, exceeding the ERA project goal of 75 percent reduction, and the combustors proved to have stable combustion with room to maneuver on fuel flow splits for operability.

Paradigms for adaptive statistical information designs: practical experiences and strategies.

PubMed

Wang, Sue-Jane; Hung, H M James; O'Neill, Robert

2012-11-10

In the last decade or so, interest in adaptive design clinical trials has gradually been directed towards their use in regulatory submissions by pharmaceutical drug sponsors to evaluate investigational new drugs. Methodological advances of adaptive designs are abundant in the statistical literature since the 1970s. The adaptive design paradigm has been enthusiastically perceived to increase the efficiency and to be more cost-effective than the fixed design paradigm for drug development. Much interest in adaptive designs is in those studies with two-stages, where stage 1 is exploratory and stage 2 depends upon stage 1 results, but where the data of both stages will be combined to yield statistical evidence for use as that of a pivotal registration trial. It was not until the recent release of the US Food and Drug Administration Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics (2010) that the boundaries of flexibility for adaptive designs were specifically considered for regulatory purposes, including what are exploratory goals, and what are the goals of adequate and well-controlled (A&WC) trials (2002). The guidance carefully described these distinctions in an attempt to minimize the confusion between the goals of preliminary learning phases of drug development, which are inherently substantially uncertain, and the definitive inference-based phases of drug development. In this paper, in addition to discussing some aspects of adaptive designs in a confirmatory study setting, we underscore the value of adaptive designs when used in exploratory trials to improve planning of subsequent A&WC trials. One type of adaptation that is receiving attention is the re-estimation of the sample size during the course of the trial. We refer to this type of adaptation as an adaptive statistical information design. Specifically, a case example is used to illustrate how challenging it is to plan a confirmatory adaptive statistical information design. We highlight the substantial risk of planning the sample size for confirmatory trials when information is very uninformative and stipulate the advantages of adaptive statistical information designs for planning exploratory trials. Practical experiences and strategies as lessons learned from more recent adaptive design proposals will be discussed to pinpoint the improved utilities of adaptive design clinical trials and their potential to increase the chance of a successful drug development. Published 2012. This article is a US Government work and is in the public domain in the USA.

Lithium Treatment for Agitation in Alzheimer's disease (Lit-AD): Clinical rationale and study design.

PubMed

Devanand, D P; Strickler, Jesse G; Huey, Edward D; Crocco, Elizabeth; Forester, Brent P; Husain, Mustafa M; Vahia, Ipsit V; Andrews, Howard; Wall, Melanie M; Pelton, Gregory H

2018-05-31

Symptoms of agitation, aggression, and psychosis frequently occur in patients with Alzheimer's disease (AD). These symptoms are distressing to patients and caregivers, often lead to institutionalization, are associated with increased mortality, and are very difficult to treat. Lithium is an established treatment for bipolar and other psychotic disorders in which agitation can occur. The Lit-AD study is the first randomized, double-blind, placebo-controlled trial to assess the efficacy of lithium treatment for symptoms of agitation or aggression, with or without psychosis, in older adults diagnosed with AD. Patients are randomly assigned to low dose (150-600 mg) lithium or placebo, targeting a blood level of 0.2-0.6 mmol/L, stratified by the presence/absence of psychotic symptoms. The study duration for each patient is 12 weeks. The primary study outcome is change in the agitation/aggression domain score on the Neuropsychiatric Inventory (NPI) over the study period. The secondary outcome is improvement in neuropsychiatric symptoms defined as a 30% decrease in a NPI core score that combines agitation/aggression and psychosis domain scores. The Treatment Emergent Symptom Scale (TESS) is used to assess somatic side effects. Other exploratory analyses examine the associations between improvement on lithium and indices shown to be associated with response to lithium in bipolar disorder: serum brain-derived neurotrophic factor (BDNF) levels, a SNP in intron 1 of the ACCN1 gene, and variation at the 7q11.2 gene locus. If lithium demonstrates efficacy in this Phase II pilot trial, a Phase III study will be developed to establish its clinical utility in these patients. ClinicalTrials.gov Identifier NCT02129348. Copyright © 2018. Published by Elsevier Inc.

Cyclooxygenase-2 inhibitors for non-small-cell lung cancer: A phase II trial and literature review.

PubMed

Yokouchi, Hiroshi; Kanazawa, Kenya; Ishida, Takashi; Oizumi, Satoshi; Shinagawa, Naofumi; Sukoh, Noriaki; Harada, Masao; Ogura, Shigeaki; Munakata, Mitsuru; Dosaka-Akita, Hirotoshi; Isobe, Hiroshi; Nishimura, Masaharu

2014-09-01

Several preclinical and clinical studies have demonstrated that cyclooxygenase-2 (COX-2) inhibitors are efficient for the treatment of non-small-cell lung cancer (NSCLC). However, two recent phase III clinical trials using COX-2 inhibitors in combination with platinum-based chemotherapy failed to demonstrate a survival benefit. Thus, validation and discussion regarding the usefulness of COX-2 inhibitors for patients with NSCLC are required. We conducted a prospective trial using COX-2 inhibitors for the treatment of 50 NSCLC patients accrued between April, 2005 and July, 2006. Patients with untreated advanced NSCLC received oral meloxicam (150 mg daily), carboplatin (area under the curve = 5 mg/ml × min on day 1) and docetaxel (60 mg/m 2 on day 1) every 3 weeks. The primary endpoint was response rate. The response and disease control rates were 36.0 and 76.0%, respectively. The time-to-progression (TTP) and overall survival (OS) were 5.7 months [95% confidence interval (CI): 4.6-6.7] and 13.7 months (95% CI: 11.4-15.9), respectively. The 1-year survival ratio was 56.0%. Grade 3 neuropathy was observed in only 1 patient. We performed tumor immunohistochemistry for COX-2 and p27 and investigated the correlation between their expression and clinical outcome. COX-2 expression in the tumor tended to correlate with a higher response rate (50.0% in the high- and 18.2% in the low-COX-2 group; P=0.092). Based on our results and previous reports, various trial designs, such as the prospective use of COX-2 inhibitors only for patients with COX-2-positive NSCLC, including the exploratory analysis of biomarkers associated with the COX-2 pathway, may be worth further consideration.

Exploratory analysis of glyburide as a novel therapy for preventing brain swelling.

PubMed

Sheth, Kevin N; Kimberly, W Taylor; Elm, Jordan J; Kent, Thomas A; Yoo, Albert J; Thomalla, Götz; Campbell, Bruce; Donnan, Geoffrey A; Davis, Stephen M; Albers, Gregory W; Jacobson, Sven; del Zoppo, Gregory; Simard, J Marc; Stern, Barney J; Mandava, Pitchaiah

2014-08-01

Malignant infarction is characterized by the formation of cerebral edema, and medical treatment is limited. Preclinical data suggest that glyburide, an inhibitor of SUR1-TRPM4, is effective in preventing edema. We previously reported feasibility of the GAMES-Pilot study, a two-center prospective, open label, phase IIa trial of 10 subjects at high risk for malignant infarction based on diffusion weighted imaging (DWI) threshold of 82 cm(3) treated with RP-1127 (glyburide for injection). In this secondary analysis, we tested the hypothesis that RP-1127 may be efficacious in preventing poor outcome when compared to controls. Controls suffering large hemispheric infarction were obtained from the EPITHET and MMI-MRI studies. We first screened subjects for controls with the same DWI threshold used for enrollment into GAMES-Pilot, 82 cm(3). Next, to address imbalances, we applied a weighted Euclidean matching. Ninety day mRS 0-4, rate of decompressive craniectomy, and mortality were the primary clinical outcomes of interest. The mean age of the GAMES cohort was 51 years and initial DWI volume was 102 ± 23 cm(3). After Euclidean matching, GAMES subjects showed similar NIHSS, higher DWI volume, younger age and had mRS 0-4-90% versus 50% in controls p = 0.049; with a similar trend in mRS 0-3 (40 vs. 25%; p = 0.43) and trend toward lower mortality (10 vs. 35%; p = 0.21). In this pilot study, RP-1127-treated subjects showed better clinical outcomes when compared to historical controls. An adequately powered and randomized phase II trial of patients at risk for malignant infarction is needed to evaluate the potential efficacy of RP-1127.

Development of a Low Cost Molded Plastic Missile/RPV Control Surface Actuator

DTIC Science & Technology

1975-10-01

Glass Fiber 3 2.1.2.2 Nylon/30% Glaso Fiber 7 2.2 Phase I Testing Of Polyimide/Glass 8 j/ Burst Testsl 11tig 2.2.2atgu TechShatset S.2. Phse Cliner oldng...Dimensional and Hard- 23 a >~ ness Change Results19 2.2.4.2.3 Weight Changes 23 2.2.5 Phase II Environmental Testing 27 II I -ii TALIO ONET TABLE OF...CONTENTS (CONT’D) SECTION PAGE 2.3 Phase I Analysis and Design 27 2.3.1 Sizing and Optimizing AR 27 2.3.2 Valve Sizing 36 2.3.3 Pistons Side Load and Rocker