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Sample records for phase ii efficacy

  1. Radiosensitizing efficacy of iso-metronidazole after intravesical application in bladder cancer. A clinical phase II study

    International Nuclear Information System (INIS)

    Kob, D.; Lilienthal, A.; Bauhardt, H.; Merkle, K.; Schroeder, E.; Schroeder, E.; Hentschel, M.

    1991-01-01

    The radiosensitizing efficacy of iso-Metronidazole, a 4-Nitroimidazole derivative, was evaluated in a prospective clinical phase II study. The results of combined radiotherapy of 25 patients with bladder cancer were compared with those of a control group of 25 patients treated with radiotherapy only. Tumor regression six months after radiotherapy was used as an endpoint. The surgical procedure was performed as double TUR. Evaluating the local tumor control after additional application of iso-Metronidazole a gain factor of 1.2 is obtained. (orig.) [de

  2. Phase II study of safety and efficacy of motesanib in patients with progressive or symptomatic, advanced or metastatic medullary thyroid cancer

    DEFF Research Database (Denmark)

    Schlumberger, Martin J; Elisei, Rossella; Bastholt, Lars

    2009-01-01

    PURPOSE: This phase II study investigated the efficacy and tolerability of motesanib, an investigational, highly selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3; platelet-derived growth factor receptor; and Kit in advanced medullary thyroid cancer (MTC). PATIENTS A...

  3. Efficacy and safety of bevacizumab for the treatment of advanced hepatocellular carcinoma: a systematic review of phase II trials.

    Directory of Open Access Journals (Sweden)

    Ping Fang

    Full Text Available BACKGROUND: Hepatocellular carcinoma (HCC is a common cancer associated with a poor prognosis. Bevacizumab is a monoclonal antibody that binds vascular endothelial growth factor, a mediator of tumor angiogenesis. Bevacizumab is currently under investigation as treatment for HCC. We performed a systematic review of the efficacy and safety of bevacizumab for the treatment of advanced HCC. METHODS: PubMed, the Cochrane Library, and Google Scholar were searched using the terms "bevacizumab AND hepatocellular carcinoma AND (advanced OR unresectable". Phase II trials of bevacizumab for the treatment of advanced HCC were included. Outcomes of interest included progression-free and overall survival (PFS and OS, tumor response, and toxicities. RESULTS: A total of 26 records were identified. Of these, 18 were excluded. Hence, eight trials involving 300 patients were included. Bevacizumab was given as monotherapy (n = 1 trial or in combination with erlotinib (n = 4 trials, capecitabine (n = 1 trial, capecitabine+oxaliplatin (n = 1 trial, or gemcitabine+oxaliplatin (n = 1 trial. Most trials (five of eight reported median PFS and OS between 5.3 months and 9.0 months and 5.9 and 13.7 months, respectively. The disease control rate was consistent in five of eight trials, ranging from 51.1% to 76.9%. The response and partial response rates ranged from 0 to 23.7%, but were around 20% in four trials. Only one patient had a complete response. Frequently reported Grade 3/4 toxicities were increased aspartate transaminase/alanine transaminase (13%, fatigue (12%, hypertension (10%, diarrhea (8%, and neutropenia (5%. Thirty patients experienced gastrointestinal bleeding (grade 1/2 = 18, grade 3/4 = 12, typically due to esophageal varices. CONCLUSIONS: Bevacizumab shows promise as an effective and tolerable treatment for advanced HCC. The reported efficacy of bevacizumab appears to compare favorably with that of sorafenib, the only currently

  4. Preoperative chemoradiotherapy in locally advanced gastric cancer, a phase I/II feasibility and efficacy study

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    Trip, Anouk K. [Department of Radiation Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Poppema, Boelo J. [Department of Medical Oncology, University Medical Centre Groningen (Netherlands); Berge Henegouwen, Mark I. van [Department of Surgical Oncology, Academic Medical Centre – University of Amsterdam (Netherlands); Siemerink, Ester [Department of Internal Medicine, Ziekenhuisgroep Twente, Hengelo (Netherlands); Beukema, Jannet C. [Department of Radiation Oncology, University Medical Centre Groningen (Netherlands); Verheij, Marcel [Department of Radiation Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Plukker, John T.M. [Department of Surgical Oncology, University Medical Centre Groningen (Netherlands); Richel, Dick J. [Department of Medical Oncology, Academic Medical Centre – University of Amsterdam (Netherlands); Hulshof, Maarten C.C.M. [Department of Radiation Oncology, Academic Medical Centre – University of Amsterdam (Netherlands); Sandick, Johanna W. van [Department of Surgical Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Cats, Annemieke [Department of Gastroenterology and Hepatology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Jansen, Edwin P.M. [Department of Radiation Oncology, Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Hospers, Geke A.P., E-mail: g.a.p.hospers@umcg.nl [Department of Medical Oncology, University Medical Centre Groningen (Netherlands)

    2014-08-15

    Objectives: This study was initiated to investigate the feasibility and efficacy of preoperative radiotherapy with weekly paclitaxel and carboplatin in locally advanced gastric cancer. Methods: In a prospective study, patients with locally advanced gastric cancer stage IB-IV(M0) were treated with chemoradiotherapy followed by surgery 4–6 weeks after the last irradiation. Chemoradiotherapy consisted of radiation to a total dose of 45 Gy given in 25 fractions of 1.8 Gy, combined with concurrent weekly carboplatin and paclitaxel. Results: Between December 2007 and January 2012, 25 patients with cT3 (64%) or cT4 (36%) gastric cancer were included. One patient discontinued concurrent chemotherapy in the 4th week due to toxicity, but completed radiotherapy. Another patient discontinued chemoradiotherapy after the 3rd week due to progressive disease. Grade III adverse events of chemoradiotherapy were: gastrointestinal 12%, haematological 12% and other 8%. All patients, except one who developed progressive disease, were operated. Surgical complications were: general/infectious 48%, anastomotic leakage 12%, and bowel perforation 8%. Postoperative mortality was 4%. Microscopically radical resection rate was 72%. Pathological complete response rate was 16% and near complete response rate 24%. Conclusions: In this study, preoperative chemoradiotherapy for patients with locally advanced gastric cancer was associated with manageable toxicity and encouraging pathological response rates.

  5. Preoperative chemoradiotherapy in locally advanced gastric cancer, a phase I/II feasibility and efficacy study

    International Nuclear Information System (INIS)

    Trip, Anouk K.; Poppema, Boelo J.; Berge Henegouwen, Mark I. van; Siemerink, Ester; Beukema, Jannet C.; Verheij, Marcel; Plukker, John T.M.; Richel, Dick J.; Hulshof, Maarten C.C.M.; Sandick, Johanna W. van; Cats, Annemieke; Jansen, Edwin P.M.; Hospers, Geke A.P.

    2014-01-01

    Objectives: This study was initiated to investigate the feasibility and efficacy of preoperative radiotherapy with weekly paclitaxel and carboplatin in locally advanced gastric cancer. Methods: In a prospective study, patients with locally advanced gastric cancer stage IB-IV(M0) were treated with chemoradiotherapy followed by surgery 4–6 weeks after the last irradiation. Chemoradiotherapy consisted of radiation to a total dose of 45 Gy given in 25 fractions of 1.8 Gy, combined with concurrent weekly carboplatin and paclitaxel. Results: Between December 2007 and January 2012, 25 patients with cT3 (64%) or cT4 (36%) gastric cancer were included. One patient discontinued concurrent chemotherapy in the 4th week due to toxicity, but completed radiotherapy. Another patient discontinued chemoradiotherapy after the 3rd week due to progressive disease. Grade III adverse events of chemoradiotherapy were: gastrointestinal 12%, haematological 12% and other 8%. All patients, except one who developed progressive disease, were operated. Surgical complications were: general/infectious 48%, anastomotic leakage 12%, and bowel perforation 8%. Postoperative mortality was 4%. Microscopically radical resection rate was 72%. Pathological complete response rate was 16% and near complete response rate 24%. Conclusions: In this study, preoperative chemoradiotherapy for patients with locally advanced gastric cancer was associated with manageable toxicity and encouraging pathological response rates

  6. Efficacy and tolerability of lodenafil carbonate for oral therapy in erectile dysfunction: a phase II clinical trial.

    Science.gov (United States)

    Glina, Sidney; Toscano, Iderpol; Gomatzky, Celso; de Góes, Plínio Moreira; Júnior, Archimedes Nardozza; Claro, Joaquim Francisco de Almeida; Pagani, Eduardo

    2009-02-01

    Oral treatment with phosphodiesterase type 5 inhibitor (PDE5) is considered the first-line treatment for patients with erectile dysfunction (ED). Lodenafil carbonate (LC) is a novel PDE5. This is a phase II, prospective, randomized, double-blind, and placebo controlled clinical trial of LC. Efficacy end points were International Index of Sexual Function (IIEF) erectile domain, IIEF questions 3 and 4, and Sexual Encounter Profile (SEP) questions 2 and 3, before and after the use of LC or placebo. Seventy-two men older than 18 years, with ED for at least 6 months with stable sexual relationship were enrolled. Patients were randomized to placebo or LC 80 mg, 40 mg, or 20 mg and followed for 4 weeks. IIEF erectile domain scores before and after the use of medications were (mean +/- standard deviation [SD]): placebo: 11.9 +/- 3.4 and 12.6 +/- 5.5; LC 20 mg: 15.8 +/- 4.1 and 18.9 +/- 6.6; LC 40 mg: 11.9 +/- 4.4 and 15.4 +/- 8.1; LC 80 mg: 14.2 +/- 4.7 and 22.8 +/- 6.0 (ANOVA P < 0.01). The SEP-2 scores before and after the use of medications were (Mean +/- SD): placebo: 71.0 +/- 33.1 and 51.2 +/- 43.1; LC 20 mg 70.3 +/- 34.2 and 75.5 +/- 31.5; LC 40 mg: 48.4 +/- 42.1 and 60.8 +/- 42.5; LC 80 mg: 68.6 +/- 33.5 and 89.6 +/- 26.0. The SEP-3 scores were: placebo 23.3 +/- 27.6 and 33.6 +/- 42.3; LC 20 mg: 32.3 +/- 38.9 and 51.2 +/- 41.7; LC 40 mg: 39.7 +/- 44.7 and 46.7 +/- 41.1; LC 80 mg* 17.2 +/- 29.5 and 74.3 +/- 36.4 (*P < 0.05 for difference to placebo). The drug was well tolerated. Adverse reactions were mild and self-limited and included headache, rhinitis, flushing, color visual disorders, and dyspepsia. This study showed that the dosage of 80 mg of LC was significantly more efficacious than placebo and well tolerated.

  7. Phase II open-label study to assess efficacy and safety of lenalidomide in combination with cetuximab in KRAS-mutant metastatic colorectal cancer.

    Directory of Open Access Journals (Sweden)

    Salvatore Siena

    Full Text Available This study aimed to assess the efficacy and safety of combination treatment with lenalidomide and cetuximab in KRAS-mutant metastatic colorectal cancer patients. This was a phase II multicenter, open-label trial comprising a safety lead-in phase (phase IIa to determine the maximum tolerated dose, and a randomized proof of concept phase (phase IIb to determine the response rate of lenalidomide plus cetuximab combination therapy. Phase IIa treatment comprised oral lenalidomide (starting dose 25 mg/day and intravenous cetuximab (400 mg/m(2 followed by weekly 250 mg/m(2 in 28-day cycles. In phase IIb patients were randomized to either the phase IIa treatment schedule of lenalidomide plus cetuximab combination therapy or lenalidomide 25 mg/day monotherapy. Eight patients were enrolled into phase IIa. One patient developed a dose-limiting toxicity and the maximum tolerated dose of lenalidomide was determined at 25 mg/day. Forty-three patients were enrolled into phase IIb proof of concept. Best response was stable disease in 9 patients and study enrollment was terminated prematurely due to lack of efficacy in both treatment arms and failure to achieve the planned response objective. The majority of adverse events were grade 1 and 2. In both phases, the adverse events most commonly attributed to any study drugs were fatigue, rash and other skin disorders, diarrhea, nausea, and stomatitis. Thirty-nine deaths occurred; none was related to study drug. The combination of lenalidomide and cetuximab appeared to be well tolerated but did not have clinically meaningful activity in KRAS-mutant metastatic colorectal cancer patients.Clinicaltrials.gov NCT01032291.

  8. Results of a phase I/II open-label, safety and efficacy trial of coagulation factor IX (recombinant), albumin fusion protein in haemophilia B patients.

    Science.gov (United States)

    Martinowitz, U; Lissitchkov, T; Lubetsky, A; Jotov, G; Barazani-Brutman, T; Voigt, C; Jacobs, I; Wuerfel, T; Santagostino, E

    2015-11-01

    rIX-FP is a coagulation factor IX (recombinant), albumin fusion protein with more than fivefold half-life prolongation over other standard factor IX (FIX) products available on the market. This prospective phase II, open-label study evaluated the safety and efficacy of rIX-FP for the prevention of bleeding episodes during weekly prophylaxis and assessed the haemostatic efficacy for on-demand treatment of bleeding episodes in previously treated patients with haemophilia B. The study consisted of a 10-14 day evaluation of rIX-FP pharmacokinetics (PK), and an 11 month safety and efficacy evaluation period with subjects receiving weekly prophylaxis treatment. Safety was evaluated by the occurrence of related adverse events, and immunogenic events, including development of inhibitors. Efficacy was evaluated by annualized spontaneous bleeding rate (AsBR), and the number of injections to achieve haemostasis. Seventeen subjects participated in the study, 13 received weekly prophylaxis and 4 received episodic treatment only. No inhibitors were detected in any subject. The mean and median AsBR were 1.25, and 1.13 respectively in the weekly prophylaxis arm. All bleeding episodes were treated with 1 or 2 injections of rIX-FP. Three prophylaxis subjects who were treated on demand prior to study entry had >85% reduction in AsBR compared to the bleeding rate prior to study entry. This study demonstrated the efficacy for weekly routine prophylaxis of rIX-FP to prevent spontaneous bleeding episodes and for the treatment of bleeding episodes. In addition no safety issues were detected during the study and an improved PK profile was demonstrated. © 2015 CSL Behring. Haemophilia published by John Wiley & Sons Ltd.

  9. Aerospace Systems Monitor, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Proposal Title: Aerospace Systems Monitor PHASE 1 Technical Abstract: This Phase II STTR project will continue development and commercialization of the Aerospace...

  10. Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: Results of an open-label Phase I and a randomized, standard-of-care-controlled Phase I/II study

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    Nativ Ofer

    2012-11-01

    Full Text Available Abstract Background Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH are useful hemostatic adjuvants, each TAH has associated disadvantages. Methods We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product―fibrin pad―to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N = 10, and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC-controlled Phase I/II study (N = 7 in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10 min following randomization, analyzed by Fisher exact tests at 5% significance level. Results Phase I (N = 10: All patients completed the study. Hemostasis was achieved within 3–4 min (average = 3.1 min of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N = 7: Hemostatic success at 10 min (primary endpoint was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial

  11. Phase II Final Report

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    Schuknecht, Nate [Project Manager; White, David [Principle Investigator; Hoste, Graeme [Research Engineer

    2014-09-11

    The SkyTrough DSP will advance the state-of-the-art in parabolic troughs for utility applications, with a larger aperture, higher operating temperature, and lower cost. The goal of this project was to develop a parabolic trough collector that enables solar electricity generation in the 2020 marketplace for a 216MWe nameplate baseload power plant. This plant requires an LCOE of 9¢/kWhe, given a capacity factor of 75%, a fossil fuel limit of 15%, a fossil fuel cost of $6.75/MMBtu, $25.00/kWht thermal storage cost, and a domestic installation corresponding to Daggett, CA. The result of our optimization was a trough design of larger aperture and operating temperature than has been fielded in large, utility scale parabolic trough applications: 7.6m width x 150m SCA length (1,118m2 aperture), with four 90mm diameter × 4.7m receivers per mirror module and an operating temperature of 500°C. The results from physical modeling in the System Advisory Model indicate that, for a capacity factor of 75%: The LCOE will be 8.87¢/kWhe. SkyFuel examined the design of almost every parabolic trough component from a perspective of load and performance at aperture areas from 500 to 2,900m2. Aperture-dependent design was combined with fixed quotations for similar parts from the commercialized SkyTrough product, and established an installed cost of $130/m2 in 2020. This project was conducted in two phases. Phase I was a preliminary design, culminating in an optimum trough size and further improvement of an advanced polymeric reflective material. This phase was completed in October of 2011. Phase II has been the detailed engineering design and component testing, which culminated in the fabrication and testing of a single mirror module. Phase II is complete, and this document presents a summary of the comprehensive work.

  12. Pharmacokinetics, safety, and efficacy of APF530 (extended-release granisetron) in patients receiving moderately or highly emetogenic chemotherapy: results of two Phase II trials

    International Nuclear Information System (INIS)

    Gabrail, Nashat; Yanagihara, Ronald; Spaczyński, Marek; Cooper, William; O’Boyle, Erin; Smith, Carrie; Boccia, Ralph

    2015-01-01

    Despite advances with new therapies, a significant proportion of patients (>30%) suffer delayed-onset chemotherapy-induced nausea and vomiting (CINV) despite use of antiemetics. APF530 is a sustained-release subcutaneous (SC) formulation of granisetron for preventing CINV. APF530 pharmacokinetics, safety, and efficacy were studied in two open-label, single-dose Phase II trials (C2005-01 and C2007-01, respectively) in patients receiving moderately emetogenic chemotherapy or highly emetogenic chemotherapy. In C2005-01, 45 patients received APF530 250, 500, or 750 mg SC (granisetron 5, 10, or 15 mg, respectively). In C2007-01, 35 patients were randomized to APF530 250 or 500 mg SC. Injections were given 30 to 60 minutes before single-day moderately emetogenic chemotherapy or highly emetogenic chemotherapy. Plasma granisetron was measured from predose to 168 hours after study drug administration. Safety and efficacy were also evaluated. APF530 pharmacokinetics were dose proportional, with slow absorption and elimination of granisetron after a single SC dose. Median time to maximum plasma concentration and half-life were similar for APF530 250 and 500 mg in both trials, with no differences between the groups receiving moderately and highly emetogenic chemotherapy. Exposure to granisetron was maintained at a therapeutic level over the delayed-onset phase, at least 168 hours. Adverse events in both trials were as expected for granisetron; injection site reactions (eg, erythema and induration) were predominantly mild and seen in ≤20% of patients. Complete responses (no emesis, with no rescue medication) were obtained in the acute, delayed, and overall phases in ≥80% and ≥75% of patients in both trials with the 250 and 500 mg doses, respectively. After a single injection of APF530, there were dose-proportional pharmacokinetics and sustained concentrations of granisetron over 168 hours. The 250 and 500 mg doses were well tolerated and maintained therapeutic granisetron

  13. Efficacy and safety of retinol palmitate ophthalmic solution in the treatment of dry eye: a Japanese Phase II clinical trial.

    Science.gov (United States)

    Toshida, Hiroshi; Funaki, Toshinari; Ono, Koichi; Tabuchi, Nobuhito; Watanabe, Sota; Seki, Tamotsu; Otake, Hiroshi; Kato, Takuji; Ebihara, Nobuyuki; Murakami, Akira

    2017-01-01

    The purpose of this study was to investigate the efficacy and safety of the administration of retinol palmitate (VApal) ophthalmic solution (500 IU/mL) for the treatment of patients with dry eye. This study included 66 patients with dry eye. After a 2-week washout period, patients were randomized (1:1) into either a VApal ophthalmic solution or a placebo group, and a single drop of either solution was administered six times daily for 4 weeks. Efficacy measures were 12 subjective symptoms, rose bengal (RB) and fluorescein staining scores, tear film breakup time, and tear secretion. Safety measures included clinical blood and urine analyses and adverse event recordings. In comparisons of the two groups, the mean change in RB staining score from baseline was significantly lower in the VApal group at 2 and 4 weeks ( P ophthalmic solution (500 IU/mL) is safe and effective for the treatment of patients with dry eye.

  14. Efficacy and safety of belimumab in patients with rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled, dose-ranging Study.

    Science.gov (United States)

    Stohl, William; Merrill, Joan T; McKay, James D; Lisse, Jeffrey R; Zhong, Z John; Freimuth, William W; Genovese, Mark C

    2013-05-01

    To evaluate the efficacy/safety of belimumab in patients with rheumatoid arthritis (RA). Patients fulfilling American College of Rheumatology (ACR) criteria for RA for ≥ 1 year who had at least moderate disease activity while receiving stable disease-modifying antirheumatic drug (DMARD) therapy and failed ≥ 1 DMARD were randomly assigned to placebo or belimumab 1, 4, or 10 mg/kg, administered intravenously on Days 1, 14, and 28, and then every 4 weeks for 24 weeks (n = 283). This was followed by an optional 24-week extension (n = 237) in which all patients received belimumab. Primary efficacy endpoint was the Week 24 ACR20 response. Week 24 ACR20 responses with placebo and belimumab 1, 4, and 10 mg/kg were 15.9%, 34.7% (p = 0.010), 25.4% (p = 0.168), and 28.2% (p = 0.080), respectively. Patients taking any belimumab dose who continued with belimumab in the open-label extension had an ACR20 response of 41% at 48 weeks. A similar ACR20 response (42%) at 48 weeks was seen in patients taking placebo who switched in the extension to belimumab 10 mg/kg. Greater response rates were observed in patients who at baseline were rheumatoid factor-positive, anticitrullinated protein antibody-positive, or tumor necrosis factor inhibitor-naive, or had elevated C-reactive protein levels, Disease Activity Score 28 > 5.1, or low B lymphocyte stimulator levels (< 0.858 ng/ml). Adverse event rates were similar across treatment groups. In this phase II trial, belimumab demonstrated efficacy and was generally well tolerated in patients with RA who had failed previous therapies. [ClinicalTrials.gov identifier NCT00071812].

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

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

    2015-04-15

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

  16. Efficacy and Safety of AmBisome in Combination with Sodium Stibogluconate or Miltefosine and Miltefosine Monotherapy for African Visceral Leishmaniasis: Phase II Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Monique Wasunna

    2016-09-01

    Full Text Available SSG&PM over 17 days is recommended as first line treatment for visceral leishmaniasis in eastern Africa, but is painful and requires hospitalization. Combination regimens including AmBisome and miltefosine are safe and effective in India, but there are no published data from trials of combination therapies including these drugs from Africa.A phase II open-label, non-comparative randomized trial was conducted in Sudan and Kenya to evaluate the efficacy and safety of three treatment regimens: 10 mg/kg single dose AmBisome plus 10 days of SSG (20 mg/kg/day, 10 mg/kg single dose AmBisome plus 10 days of miltefosine (2.5mg/kg/day and miltefosine alone (2.5 mg/kg/day for 28 days. The primary endpoint was initial parasitological cure at Day 28, and secondary endpoints included definitive cure at Day 210, and pharmacokinetic (miltefosine and pharmacodynamic assessments.In sequential analyses with 49-51 patients per arm, initial cure was 85% (95% CI: 73-92 in all arms. At D210, definitive cure was 87% (95% CI: 77-97 for AmBisome + SSG, 77% (95% CI 64-90 for AmBisome + miltefosine and 72% (95% CI 60-85 for miltefosine alone, with lower efficacy in younger patients, who weigh less. Miltefosine pharmacokinetic data indicated under-exposure in children compared to adults.No major safety concerns were identified, but point estimates of definitive cure were less than 90% for each regimen so none will be evaluated in Phase III trials in their current form. Allometric dosing of miltefosine in children needs to be evaluated.The study was registered with ClinicalTrials.gov, number NCT01067443.

  17. Efficacy and safety of retinol palmitate ophthalmic solution in the treatment of dry eye: a Japanese Phase II clinical trial

    Directory of Open Access Journals (Sweden)

    Toshida H

    2017-06-01

    Full Text Available Hiroshi Toshida,1 Toshinari Funaki,2 Koichi Ono,3 Nobuhito Tabuchi,4 Sota Watanabe,4 Tamotsu Seki,5 Hiroshi Otake,6 Takuji Kato,7 Nobuyuki Ebihara,8 Akira Murakami2 1Department of Ophthalmology, Juntendo University Shizuoka Hospital, Shizuoka, 2Department of Ophthalmology, Juntendo University Graduate School of Medicine, 3Department of Ophthalmology, Juntendo Tokyo Koto Geriatric Medical Center, Tokyo, 4Pharmaceutical Research Laboratories, Lion Corporation, Kanagawa, 5Tamagawa Eye Clinic, Tokyo, 6Otake Eye Clinic, Kanagawa, 7Kato Eye Clinic, Tokyo, 8Department of Ophthalmology, Juntendo University Urayasu Hospital, Chiba, Japan Purpose: The purpose of this study was to investigate the efficacy and safety of the administration of retinol palmitate (VApal ophthalmic solution (500 IU/mL for the treatment of patients with dry eye. Patients and methods: This study included 66 patients with dry eye. After a 2-week washout period, patients were randomized (1:1 into either a VApal ophthalmic solution or a placebo group, and a single drop of either solution was administered six times daily for 4 weeks. Efficacy measures were 12 subjective symptoms, rose bengal (RB and fluorescein staining scores, tear film breakup time, and tear secretion. Safety measures included clinical blood and urine analyses and adverse event recordings. Results: In comparisons of the two groups, the mean change in RB staining score from baseline was significantly lower in the VApal group at 2 and 4 weeks (P<0.05 and P<0.01, respectively. Furthermore, the fluorescein clearance rate (fluorescein staining score was significantly higher in the VApal group at 4 weeks (P<0.05. The VApal group showed a significant improvement in blurred vision at 1 and 2 weeks (P<0.01 and P<0.05, respectively, and the mean change in the total score for subjective symptoms from baseline was significantly lower in the VApal group at 1 week (P<0.05. In before- and after-intervention comparisons, the

  18. A randomized, double-blind, multicenter Phase II study comparing the efficacy and safety of oral nemonoxacin with oral levofloxacin in the treatment of community-acquired pneumonia.

    Science.gov (United States)

    Liu, Yang; Zhang, Yingyuan; Wu, Jufang; Zhu, Demei; Sun, Shenghua; Zhao, Li; Wang, Xuefeng; Liu, Hua; Ren, Zhenyi; Wang, Changzheng; Xiu, Qingyu; Xiao, Zuke; Cao, Zhaolong; Cui, Shehuai; Yang, Heping; Liang, Yongjie; Chen, Ping; Lv, Yuan; Hu, Chengping; Lv, Xiaoju; Liu, Shuang; Kuang, Jiulong; Li, Jianguo; Wang, Dexi; Chang, Liwen

    2017-12-01

    To compare the clinical efficacy and safety of nemonoxacin with levofloxacin in treating community-acquired pneumonia (CAP) in a Phase II clinical trial. One hundred ninety-two patients with CAP were randomized to receive oral nemonoxacin (500 mg or 750 mg) or levofloxacin (500 mg) once daily for 7-10 days. Clinical and bacteriological responses were determined at the test of cure (TOC) visit in the full analysis set (FAS). The clinical cure rate of nemonoxacin (500 mg), nemonoxacin (750 mg), and levofloxacin (500 mg) was 93.3%, 87.3%, and 88.5%, respectively, in the FAS (n = 168), and 93.0%, 93.9%, and 88.9%, respectively in the per protocol set (n = 152). At the TOC visit, nemonoxacin at 500 mg and 750 mg was proven to be noninferior to levofloxacin at 500 mg in the FAS in terms of clinical efficacy. The overall bacteriological success rate was 83.3% in both nemonoxacin groups and 80.0% in the levofloxacin 500 mg group in the bacteriological FAS. The comprehensive efficacy rate was comparable among the three groups (87.5% for the nemonoxacin 500 mg group, 93.8% for the nemonoxacin 750 mg group, and 81.3% for the levofloxacin 500 mg group). Most drug-related adverse events were mild and transient, mainly gastrointestinal symptoms such as nausea and vomiting, transient neutropenia, and elevated liver enzymes. No drug-related serious adverse events occurred. Either 500 mg or 750 mg of oral nemonoxacin taken once daily for 7-10 days demonstrated high clinical and bacteriological success rates in Chinese adult patients with CAP. Nemonoxacin at 500 mg once daily for 7-10 days is recommended for future Phase III clinical trials. ClinicalTrials.gov identifier: NCT01537250. Copyright © 2015. Published by Elsevier B.V.

  19. Pharmacokinetics, safety, and efficacy of APF530 (extended-release granisetron in patients receiving moderately or highly emetogenic chemotherapy: results of two Phase II trials

    Directory of Open Access Journals (Sweden)

    Gabrail N

    2015-03-01

    Full Text Available Nashat Gabrail,1 Ronald Yanagihara,2 Marek Spaczyński,3 William Cooper,4 Erin O'Boyle,5 Carrie Smith,1 Ralph Boccia6 1Gabrail Cancer Center, Canton, OH, USA; 2St Louise Regional Hospital, Gilroy, CA, USA; 3Department of Gynecology, Obstetrics and Gynecologic Oncology, University of Medical Sciences, Poznan, Poland; 4TFS International, Flemington, NJ, USA; 5FibroGen, Inc., San Francisco, CA, USA; 6Center for Cancer and Blood Disorders, Bethesda, MD, USA Background: Despite advances with new therapies, a significant proportion of patients (>30% suffer delayed-onset chemotherapy-induced nausea and vomiting (CINV despite use of antiemetics. APF530 is a sustained-release subcutaneous (SC formulation of granisetron for preventing CINV. APF530 pharmacokinetics, safety, and efficacy were studied in two open-label, single-dose Phase II trials (C2005-01 and C2007-01, respectively in patients receiving moderately emetogenic chemotherapy or highly emetogenic chemotherapy. Methods: In C2005-01, 45 patients received APF530 250, 500, or 750 mg SC (granisetron 5, 10, or 15 mg, respectively. In C2007-01, 35 patients were randomized to APF530 250 or 500 mg SC. Injections were given 30 to 60 minutes before single-day moderately emetogenic chemotherapy or highly emetogenic chemotherapy. Plasma granisetron was measured from predose to 168 hours after study drug administration. Safety and efficacy were also evaluated. Results: APF530 pharmacokinetics were dose proportional, with slow absorption and elimination of granisetron after a single SC dose. Median time to maximum plasma concentration and half-life were similar for APF530 250 and 500 mg in both trials, with no differences between the groups receiving moderately and highly emetogenic chemotherapy. Exposure to granisetron was maintained at a therapeutic level over the delayed-onset phase, at least 168 hours. Adverse events in both trials were as expected for granisetron; injection site reactions (eg, erythema

  20. Options Study - Phase II

    Energy Technology Data Exchange (ETDEWEB)

    R. Wigeland; T. Taiwo; M. Todosow; W. Halsey; J. Gehin

    2010-09-01

    The Options Study has been conducted for the purpose of evaluating the potential of alternative integrated nuclear fuel cycle options to favorably address the issues associated with a continuing or expanding use of nuclear power in the United States. The study produced information that can be used to inform decisions identifying potential directions for research and development on such fuel cycle options. An integrated nuclear fuel cycle option is defined in this study as including all aspects of the entire nuclear fuel cycle, from obtaining natural resources for fuel to the ultimate disposal of used nuclear fuel (UNF) or radioactive wastes. Issues such as nuclear waste management, especially the increasing inventory of used nuclear fuel, the current uncertainty about used fuel disposal, and the risk of nuclear weapons proliferation have contributed to the reluctance to expand the use of nuclear power, even though it is recognized that nuclear power is a safe and reliable method of producing electricity. In this Options Study, current, evolutionary, and revolutionary nuclear energy options were all considered, including the use of uranium and thorium, and both once-through and recycle approaches. Available information has been collected and reviewed in order to evaluate the ability of an option to clearly address the challenges associated with the current implementation and potential expansion of commercial nuclear power in the United States. This Options Study is a comprehensive consideration and review of fuel cycle and technology options, including those for disposal, and is not constrained by any limitations that may be imposed by economics, technical maturity, past policy, or speculated future conditions. This Phase II report is intended to be used in conjunction with the Phase I report, and much information in that report is not repeated here, although some information has been updated to reflect recent developments. The focus in this Options Study was to

  1. Prospective phase II study evaluating the efficacy of swallow ability screening tests and pneumonia prevention using a team approach for elderly patients with gastric cancer.

    Science.gov (United States)

    Miki, Yuichiro; Makuuchi, Rie; Honda, Shinsaku; Tokunaga, Masanori; Tanizawa, Yutaka; Bando, Etsuro; Kawamura, Taiichi; Yurikusa, Takashi; Tanuma, Akira; Terashima, Masanori

    2018-03-01

    Aging partly impairs swallowing function, which is considered a risk factor for postoperative pneumonia (PP). We evaluated the efficacy of a new team-based strategy to reduce the incidence of PP in elderly patients with gastric cancer. This single-center, prospective phase II study included elderly patients (≥75 years old) with gastric cancer undergoing gastric surgery. The primary endpoint was the incidence of Clavien-Dindo grade II or higher PP. Patients were initially screened using three swallowing function screening tests: a symptom questionnaire, the modified water swallow test (MSWT), and the repetitive saliva swallowing test (RSST). All patients were provided standard preoperative oral checks and care and simple neck muscle training. For patients who screened positive, a videofluorographic swallowing study was performed; if an abnormality was found, the patient was given intensive swallowing rehabilitation both pre- and postoperatively. Of 86 eligible patients enrolled, PP developed in 3 (3.5%). The 60% confidence interval of 1.8-6.3% had an upper limit below the prespecified threshold of 7.8%. Positive screening results were found for 19 patients (22.1%) on the symptom questionnaire, 3 (3.5%) on the MSWT, and 1 (1.2%) on the RSST. PP was not observed in any patients who screened positive. In conclusion, although the screening tests we adopted here were not sufficient to identify patients at high risk of aspiration pneumonia, perioperative interventions using a team approach might be effective in reducing the incidence of PP in elderly patients with gastric cancer.

  2. A phase II open label trial evaluating safety and efficacy of a telomerase peptide vaccination in patients with advanced hepatocellular carcinoma

    International Nuclear Information System (INIS)

    Greten, Tim F; Bruix, Jordi; Forner, Alejandro; Korangy, Firouzeh; N'Kontchou, Gisele; Barget, Nathalie; Ayuso, Carmen; Ormandy, Lars A; Manns, Michael P; Beaugrand, Michel

    2010-01-01

    The sole effective option for patients with advanced HCC is sorafenib and there is an urgent need to develop new therapeutic approaches. Immunotherapy is a promising option that deserves major investigation. In this open label, single arm clinical trial, we analyzed the effect of a low dose cyclophosphamide treatment in combination with a telomerase peptide (GV1001) vaccination in patients with advanced HCC. 40 patients with advanced HCC were treated with 300 mg/m 2 cyclophosphamide on day -3 followed by GM-CSF + GV1001 vaccinations on days 1, 3, 5, 8, 15, 22, 36 followed by 4-weekly injections. Primary endpoint of this phase II trial was tumor response; secondary endpoints evaluated were TTP, TTSP, PFS, OS, safety and immune responses. None of the patients had a complete or partial response to treatment, 17 patients (45.9%) demonstrated a stable disease six months after initiation of treatment. The median TTP was 57.0 days; the median TTSP was estimated to be 358.0 days. Cyclophosphamide, GV1001 and GM-CSF treatment were well tolerated and most adverse events, which were of grade 1 or 2, were generally related to the injection procedure and injection site reactions. GV1001 treatment resulted in a decrease in CD4 + CD25 + Foxp3 + regulatory T cells; however, no GV1001 specific immune responses were detected after vaccination. Low dose cyclophosphamide treatment followed by GV1001 vaccinations did not show antitumor efficacy as per tumor response and time to progression. Further studies are needed to analyze the effect of a combined chemo-immunotherapy to treat patients with HCC. NCT00444782

  3. A phase II open label trial evaluating safety and efficacy of a telomerase peptide vaccination in patients with advanced hepatocellular carcinoma

    Directory of Open Access Journals (Sweden)

    Ayuso Carmen

    2010-05-01

    Full Text Available Abstract Background The sole effective option for patients with advanced HCC is sorafenib and there is an urgent need to develop new therapeutic approaches. Immunotherapy is a promising option that deserves major investigation. In this open label, single arm clinical trial, we analyzed the effect of a low dose cyclophosphamide treatment in combination with a telomerase peptide (GV1001 vaccination in patients with advanced HCC. Methods 40 patients with advanced HCC were treated with 300 mg/m2 cyclophosphamide on day -3 followed by GM-CSF + GV1001 vaccinations on days 1, 3, 5, 8, 15, 22, 36 followed by 4-weekly injections. Primary endpoint of this phase II trial was tumor response; secondary endpoints evaluated were TTP, TTSP, PFS, OS, safety and immune responses. Results None of the patients had a complete or partial response to treatment, 17 patients (45.9% demonstrated a stable disease six months after initiation of treatment. The median TTP was 57.0 days; the median TTSP was estimated to be 358.0 days. Cyclophosphamide, GV1001 and GM-CSF treatment were well tolerated and most adverse events, which were of grade 1 or 2, were generally related to the injection procedure and injection site reactions. GV1001 treatment resulted in a decrease in CD4+CD25+Foxp3+ regulatory T cells; however, no GV1001 specific immune responses were detected after vaccination. Conclusions Low dose cyclophosphamide treatment followed by GV1001 vaccinations did not show antitumor efficacy as per tumor response and time to progression. Further studies are needed to analyze the effect of a combined chemo-immunotherapy to treat patients with HCC. Trial registration NCT00444782

  4. Efficacy of Rituximab in Refractory Inflammatory Myopathies Associated with Anti- Synthetase Auto-Antibodies: An Open-Label, Phase II Trial.

    Directory of Open Access Journals (Sweden)

    Yves Allenbach

    Full Text Available Anti-synthetase syndrome (anti-SS is frequently associated with myositis and interstitial lung disease (ILD. We evaluated prospectively, in a multicenter, open-label, phase II study, the efficacy of rituximab on muscle and lung outcomes.Patients were enrolled if they were refractory to conventional treatments (prednisone and at least 2 immunosuppressants. They received 1 g of rituximab at D0, D15, and M6. The primary endpoint was muscular improvement based on manual muscular testing (MMT10, Kendall score in 10 muscles at M12. Secondary endpoints were normalization of creatine kinase (CK level, ILD improvement based on forced vital capacity and/or diffuse capacity for carbon monoxide, and number and/or doses of associated immunosuppressants.Twelve patients were enrolled, and 10 completed the study. Only 2 patients presented an improvement of at least 4 points on at least two muscle groups (primary end-point. Overall, seven patients had an increase of at least 4 points on MMT10. CK level decreased from 399 IU/L (range, 48-11,718 to 74.5 IU/L (range, 40-47,857. Corticosteroid doses decreased from 52.5 mg/d (range, 10-70 to 9 mg/d (range, 7-65 and six patients had a decrease in the burden of their associated immunosuppressants. At baseline, all 10 patients presented with ILD. At M12, improvement of ILD was observed in 5 out of the 10 patients, stabilization in 4, and worsening in 1.This pilot study of rituximab treatment in patients with refractory anti-SS provided data on evolution of muscular and pulmonary parameters. Rituximab should now be evaluated in a larger, controlled study for this homogenous group of patients.Clinicaltrials.gov NCT00774462.

  5. Efficacy of gamification-based smartphone application for weight loss in overweight and obese adolescents: study protocol for a phase II randomized controlled trial.

    Science.gov (United States)

    Timpel, Patrick; Cesena, Fernando Henpin Yue; da Silva Costa, Christiane; Soldatelli, Matheus Dorigatti; Gois, Emanuel; Castrillon, Eduardo; Díaz, Lina Johana Jaime; Repetto, Gabriela M; Hagos, Fanah; Castillo Yermenos, Raul E; Pacheco-Barrios, Kevin; Musallam, Wafaa; Braid, Zilda; Khidir, Nesreen; Romo Guardado, Marcela; Roepke, Roberta Muriel Longo

    2018-06-01

    Overweight and obesity are significant public health concerns that are prevalent in younger age cohorts. Preventive or therapeutic interventions are difficult to implement and maintain over time. On the other hand, the majority of adolescents in the United States have a smartphone, representing a huge potential for innovative digitized interventions, such as weight loss programs delivered via smartphone applications. Although the number of available smartphone applications is increasing, evidence for their effectiveness in weight loss is insufficient. Therefore, the proposed study aims to assess the efficacy of a gamification-based smartphone application for weight loss in overweight and obese adolescents. The trial is designed to be a phase II, single-centre, two-arm, triple-blinded, randomized controlled trial (RCT) with a duration of 6 months. The intervention consists of a smartphone application that provides both tracking and gamification elements, while the control arm consists of an identically designed application solely with tracking features of health information. The proposed trial will be conducted in an urban primary care clinic of an academic centre in the United States of America, with expertise in the management of overweight and obese adolescents. Eligible adolescents will be followed for 6 months. Changes in body mass index z score from baseline to 6 months will be the primary outcome. Secondary objectives will explore the effects of the gamification-based application on adherence, as well as anthropometric, metabolic and behavioural changes. A required sample size of 108 participants (54 participants per group) was calculated. The benefits of the proposed study include mid-term effects in weight reduction for overweight and obese adolescents. The current proposal will contribute to fill a gap in the literature on the mid-term effects of gamification-based interventions to control weight in adolescents. This trial is a well-designed RCT that is in

  6. Safety and efficacy of high-dose tamoxifen and sulindac for desmoid tumor in children: results of a Children's Oncology Group (COG) phase II study.

    Science.gov (United States)

    Skapek, Stephen X; Anderson, James R; Hill, D Ashley; Henry, David; Spunt, Sheri L; Meyer, William; Kao, Simon; Hoffer, Fredric A; Grier, Holcombe E; Hawkins, Douglas S; Raney, R Beverly

    2013-07-01

    Desmoid fibromatosis (desmoid tumor, DT) is a soft tissue neoplasm prone to recurrence despite complete surgical resection. Numerous small retrospective reports suggest that non-cytotoxic chemotherapy using tamoxifen and sulindac may be effective for DT. We evaluated the safety and efficacy of tamoxifen and sulindac in a prospective phase II study within the Children's Oncology Group. Eligible patients were <19 years of age who had measurable DT that was recurrent or not amenable to surgery or radiation. The primary objective was to estimate progression-free survival (PFS). Patients received tamoxifen and sulindac daily for 12 months or until disease progression or intolerable toxicity occurred. Response was assessed by magnetic resonance imaging. Fifty-nine eligible patients were enrolled from 2004 to 2009; 78% were 10-18 years old. Twenty-two (38%) were previously untreated; 15 (41%) of the remaining 37 enrolling with recurrent DT had prior systemic chemotherapy and six (16%) had prior radiation. No life-threatening toxicity was reported. Twelve (40%) of 30 females developed ovarian cysts, which were asymptomatic in 11 cases. Ten patients completed therapy without disease progression or discontinuing treatment. Responses included four partial and one complete (5/59, 8%). The estimated 2-year PFS and survival rates were 36% (95% confidence interval: 0.23-0.48) and 96%, respectively. All three deaths were due to progressive DT. Tamoxifen and sulindac caused few serious side effects in children with DT, although ovarian cysts were common. However, the combination showed relatively little activity as measured by response and PFS rates. Copyright © 2012 Wiley Periodicals, Inc.

  7. Safety and Efficacy of High-Dose Tamoxifen and Sulindac for Desmoid Tumor in Children: Results of a Children’s Oncology Group (COG) Phase II Study

    Science.gov (United States)

    Skapek, Stephen X.; Anderson, James R.; Hill, D. Ashley; Henry, David; Spunt, Sheri L.; Meyer, William; Kao, Simon; Hoffer, Fredric A.; Grier, Holcombe E.; Hawkins, Douglas S.; Raney, R. Beverly

    2015-01-01

    Background Desmoid fibromatosis (desmoid tumor, DT) is a soft tissue neoplasm prone to recurrence despite complete surgical resection. Numerous small retrospective reports suggest that non-cytotoxic chemotherapy using tamoxifen and sulindac may be effective for DT. We evaluated the safety and efficacy of tamoxifen and sulindac in a prospective phase II study within the Children’s Oncology Group. Procedures Eligible patients were <19 years of age who had measurable DT that was recurrent or not amenable to surgery or radiation. The primary objective was to estimate progression-free survival (PFS). Patients received tamoxifen and sulindac daily for 12 months or until disease progression or intolerable toxicity occurred. Response was assessed by magnetic resonance imaging. Results Fifty-nine eligible patients were enrolled from 2004 to 2009; 78% were 10–18 years old. Twenty-two (38%) were previously untreated; 15 (41%) of the remaining 37 enrolling with recurrent DT had prior systemic chemotherapy and six (16%) had prior radiation. No life-threatening toxicity was reported. Twelve (40%) of 30 females developed ovarian cysts, which were asymptomatic in 11 cases. Ten patients completed therapy without disease progression or discontinuing treatment. Responses included four partial and one complete (5/59, 8%). The estimated 2-year PFS and survival rates were 36% (95% confidence interval: 0.23–0.48) and 96%, respectively. All three deaths were due to progressive DT. Conclusions Tamoxifen and sulindac caused few serious side effects in children with DT, although ovarian cysts were common. However, the combination showed relatively little activity as measured by response and PFS rates. PMID:23281268

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

    Science.gov (United States)

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

    2016-01-01

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

  9. Efficacy and Safety of Multiple Doses of Exenatide Once-Monthly Suspension in Patients With Type 2 Diabetes: A Phase II Randomized Clinical Trial.

    Science.gov (United States)

    Wysham, Carol H; MacConell, Leigh; Hardy, Elise

    2016-10-01

    This study investigated the efficacy and safety of multiple exenatide once-monthly suspension (QMS) doses of exenatide-containing microspheres in Miglyol referenced against the clinical dose of exenatide once-weekly (QW) microspheres in aqueous solution. In this phase II, randomized, controlled, single-blind study, 121 adults (∼30/arm) with type 2 diabetes and HbA1c 7.1-11.0% (54-97 mmol/mol) were randomized 1:1:1:1 to subcutaneous exenatide QW 2 mg (self-administered) or exenatide QMS 5, 8, or 11 mg (caregiver-administered) for 20 weeks. The primary end point was change in HbA1c. At baseline, mean age was 50 years, HbA1c was 8.5% (69 mmol/mol), fasting plasma glucose (FPG) was 184 mg/dL, and body weight was 98 kg. At week 20, mean ± SD HbA1c reductions were -1.54% ± 1.26% with exenatide QW and -1.29% ± 1.07%, -1.31% ± 1.66%, and -1.45% ± 0.93% with exenatide QMS 5, 8, and 11 mg, respectively (evaluable population: n = 110). There were no significant differences in HbA1c reductions among the exenatide QMS doses. FPG reductions were -34 ± 48 mg/dL with exenatide QW and -25 ± 43, -30 ± 52, and -49 ± 49 mg/dL with exenatide QMS 5, 8, and 11 mg, respectively. Weight decreased with all treatments. For exenatide QMS, nausea (16.7-23.3%) and headache (16.7-26.7%) were the most common adverse events. No major or minor hypoglycemia occurred. All doses of exenatide QMS resulted in efficacy and tolerability profiles consistent with exenatide QW. These results combined with pharmacokinetic and pharmacodynamic modeling could inform dose selection for further development. © 2016 by the American Diabetes Association.

  10. Lunar Health Monitor, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — During the Phase II Lunar Health Monitor program, Orbital Research will develop a second generation wearable sensor suite for astronaut physiologic monitoring. The...

  11. Feasibility and Efficacy of the Nintendo Wii Gaming System to Improve Balance Performance Post-Stroke: Protocol of a Phase II Randomized Controlled Trial in an Inpatient Rehabilitation Setting.

    Science.gov (United States)

    Bower, Kelly J; Clark, Ross A; McGinley, Jennifer L; Martin, Clarissa L; Miller, Kimberly J

    2013-04-01

    Balance deficits following stroke are common and debilitating. Commercially available gaming systems, such as the Nintendo(®) (Kyoto, Japan) Wii™, have been widely adopted clinically; however, there is limited evidence supporting their feasibility and efficacy for improving balance performance following stroke. The aim of this trial is to investigate the clinical feasibility and efficacy of using the Nintendo Wii gaming system as an adjunct to standard care to improve balance performance following stroke in an inpatient rehabilitation setting. Thirty participants undergoing inpatient stroke rehabilitation will be recruited into this Phase II, single-blind, randomized controlled trial. Participants will be allocated into a Balance or Upper Limb Group, and both groups will perform activities using the Nintendo Wii in addition to their standard care. Participants will attend three 45-minute sessions per week, for a minimum of 2 and a maximum of 4 weeks. The main focus of the study is to investigate the feasibility of the intervention protocol. This will be evaluated through recruitment, retention, adherence, acceptability, and safety. The Step Test and Functional Reach Test will be the primary efficacy outcomes. Secondary outcomes will include force platform, mobility, and upper limb measures. Assessments will occur at baseline, 2 weeks, and 4 weeks after study entry. To the authors' knowledge, this will be the largest randomized clinical trial to investigate the feasibility and efficacy of the Nintendo Wii gaming system for improving balance performance in a stroke population. The results will inform the design of a Phase III multicenter trial.

  12. Status of Gerda Phase II

    Energy Technology Data Exchange (ETDEWEB)

    Wagner, Victoria [Max-Planck-Institut fuer Kernphysik, Heidelberg (Germany); Collaboration: GERDA-Collaboration

    2016-07-01

    The GERDA experiment is designed to search for neutrinoless double beta (0νββ) decay of {sup 76}Ge. In Phase I of the experiment a background index (BI) of 10{sup -2} cts/(keV.kg.yr) was reached. No signal has been found and a lower limit on the half-life of 2.1.10{sup 25} yr (at 90% C.L.) is extracted. The aim of Phase II is to double the Ge mass and further reduce the BI by an order of magnitude to explore half-lives of about 10{sup 26} yr. Thirty new Broad Energy Germanium (BEGe) detectors have been produced. These detectors are distinct for their improved energy resolution and enhanced pulse shape discrimination of signal from background events. Further background reduction will be reached by an active veto to read out argon scintillation light. The Phase II commissioning showed that two of the major background components, external γ-rays from {sup 214}Bi and {sup 208}Tl decays, can be suppressed up to two orders of magnitude. This talk presents the current status of the GERDA Phase II upgrade.

  13. Efficacy and Safety Outcomes in Patients With Advanced Melanoma Who Discontinued Treatment With Nivolumab and Ipilimumab Because of Adverse Events: A Pooled Analysis of Randomized Phase II and III Trials.

    Science.gov (United States)

    Schadendorf, Dirk; Wolchok, Jedd D; Hodi, F Stephen; Chiarion-Sileni, Vanna; Gonzalez, Rene; Rutkowski, Piotr; Grob, Jean-Jacques; Cowey, C Lance; Lao, Christopher D; Chesney, Jason; Robert, Caroline; Grossmann, Kenneth; McDermott, David; Walker, Dana; Bhore, Rafia; Larkin, James; Postow, Michael A

    2017-12-01

    Purpose Approximately 40% of patients with advanced melanoma who received nivolumab combined with ipilimumab in clinical trials discontinued treatment because of adverse events (AEs). We conducted a retrospective analysis to assess the efficacy and safety of nivolumab plus ipilimumab in patients who discontinued treatment because of AEs. Methods Data were pooled from phase II and III trials of patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks for four doses, followed by nivolumab monotherapy 3 mg/kg every 2 weeks (N = 409). Efficacy was assessed in all randomly assigned patients who discontinued because of AEs during the induction phase (n = 96) and in those who did not discontinue because of AEs (n = 233). Safety was assessed in treated patients who discontinued because of AEs (n = 176) at any time and in those who did not discontinue because of AEs (n = 231). Results At a minimum follow-up of 18 months, median progression-free survival was 8.4 months for patients who discontinued treatment because of AEs during the induction phase and 10.8 months for patients who did not discontinue because of AEs ( P = .97). Median overall survival had not been reached in either group ( P = .23). The objective response rate was 58.3% for patients who discontinued because of AEs during the induction phase and 50.2% for patients who did not discontinue. The vast majority of grade 3 or 4 AEs occurred during the induction phase, with most resolving after appropriate management. Conclusion Efficacy outcomes seemed similar between patients who discontinued nivolumab plus ipilimumab treatment because of AEs during the induction phase and those who did not discontinue because of AEs. Therefore, even after discontinuation, many patients may continue to derive benefit from combination therapy.

  14. Assessment of Correlation Between Early and Late Efficacy Endpoints to Identify Potential Surrogacy Relationships in Non-Hodgkin Lymphoma: a Literature-Based Meta-analysis of 108 Phase II and Phase III Studies.

    Science.gov (United States)

    Zhu, Rui; Lu, Dan; Chu, Yu-Waye; Chai, Akiko; Green, Michelle; Zhang, Nancy; Jin, Jin Yan

    2017-05-01

    Correlations between early and late efficacy endpoints were assessed to identify potential surrogate endpoints for overall survival (OS) or progression-free survival (PFS) with clinical trial-level data in three non-Hodgkin lymphoma (NHL) subtypes: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). One hundred and eight phase II-III trials (129 trial arms) in DLBCL, FL, and MCL were identified and included in the database. Correlations between efficacy endpoints were analyzed using weighted linear regression and Pearson's coefficient of determination (R 2 ). In newly diagnosed DLBCL, 6-month PFS was strongly correlated with 2-year OS (R 2  = 0.81, 95% confidence interval [CI] 0.51-0.96). Six-month PFS was strongly correlated with 3-year PFS (R 2  = 0.89, 95% CI 0.62-0.96) in FL and was moderately correlated with 2-year OS (R 2  = 0.69, 95% CI 0.40-0.91) in MCL trials. Linear regression determined that a 10% increase in 6-month PFS would yield a 13% ± 1.2% increase in 2-year OS in DLBCL, a 23% ± 1.1% increase in 3-year PFS in FL, or a 6.7% ± 1.0% increase in 2-year OS in MCL. Both 6-month PFS and complete response (CR) rate were moderately correlated with median PFS in FL trials with R 2  = 0.66 (95% CI 0.52-0.98) and R 2  = 0.69 (95% CI 0.22-0.89), respectively. Six-month PFS is a potential surrogate endpoint for 2-year OS in newly diagnosed DLBCL and MCL and for 3-year PFS in FL. Both 6-month PFS and CR rate are potential surrogate endpoints for median PFS in FL patients. Confirmation and validation of these correlations may facilitate early interpretation of NHL trials.

  15. A Phase II Safety and Efficacy Study of the Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor Pazopanib in Patients With Metastatic Urothelial Cancer

    Science.gov (United States)

    Pili, Roberto; Qin, Rui; Flynn, P.J.; Picus, Joel; Millward, Michael; Ho, Wing Ming; Pitot, Henry; Tan, Winston; Miles, Kiersten M.; Erlichman, Charles; Vaishampayan, Ulka

    2013-01-01

    Vascular endothelial growth factor (VEGF) is expressed in human bladder tumors. A phase II study was conducted to assess the VEGF inhibitor pazopanib in patients with metastatic, urothelial carcinoma. Nineteen patients with one prior systemic therapy were enrolled. No objective responses were observed and median progression-free survival was 1.9 months. The role of anti-VEGF therapies in urothelial carcinoma remains to be determined. Background Vascular endothelial growth factor (VEGF) is produced by bladder cancer cell lines in vitro and expressed in human bladder tumor tissues. Pazopanib is a vascular endothelial receptor tyrosine kinase inhibitor with anti-angiogenesis and anti-tumor activity in several preclinical models. A 2-stage phase II study was conducted to assess the activity and toxicity profile of pazopanib in patients with metastatic, urothelial carcinoma. Methods Patients with one prior systemic therapy for metastatic urothelial carcinoma were eligible. Patients received pazopanib at a dose of 800 mg orally for a 4-week cycle. Results Nineteen patients were enrolled. No grade 4 or 5 events were experienced. Nine patients experienced 11 grade 3 adverse events. Most common toxicities were anemia, thrombocytopenia, leucopenia, and fatigue. For stage I, none of the first 16 evaluable patients were deemed a success (complete response or partial response) by the Response Evaluation Criteria In Solid Tumors criteria during the first four 4-week cycles of treatment. Median progression-free survival was 1.9 months. This met the futility stopping rule of interim analysis, and therefore the trial was recommended to be permanently closed. Conclusions Pazopanib did not show significant activity in patients with urothelial carcinoma. The role of anti-VEGF therapies in urothelial carcinoma may need further evaluation in rational combination strategies. PMID:23891158

  16. Design of clinical trials Phase I and II with radiopharmaceuticals

    International Nuclear Information System (INIS)

    Giannone, C.A.; Soroa, V.E.

    2015-01-01

    We presented some usual designs for clinical studies in Phase I and Phase II. For Phase I we considered the 3 + 3 Classic design, designs with accelerated titration and those with dose escalation schemes with overdose control (EWOC). For Phase II designs with efficacy outcomes are presented. The design proposed by Fleming is discussed as well as those with inclusion of patients in two stages: Gehan’s design and the Optimal two–stage Simon’s design. We also discussed the design of combined endpoints of efficacy and safety of Bryant and Day with an application example of therapeutically Lu-177. Finally some proposals for phase II trials with control group are considered. (authors) [es

  17. Sample Exchange Evaluation (SEE) Report - Phase II

    International Nuclear Information System (INIS)

    Winters, W.I.

    1994-01-01

    This report describes the results from Phase II of the Sample Exchange Evaluation (SEE) Program, a joint effort to compare analytical laboratory performance on samples from the Hanford Site's high-level waste tanks. In Phase II, the program has been expanded to include inorganic constituents in addition to radionuclides. Results from Phase II that exceeded 20% relative percent difference criteria are identified

  18. Design of Phase II Non-inferiority Trials.

    Science.gov (United States)

    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.

  19. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study

    DEFF Research Database (Denmark)

    Massin, Pascale; Bandello, Francesco; Garweg, Justus G

    2010-01-01

    The expression of vascular endothelial growth factor (VEGF) is elevated in diabetic macular edema (DME). Ranibizumab binds to and inhibits multiple VEGF variants. We investigated the safety and efficacy of ranibizumab in DME involving the foveal center.......The expression of vascular endothelial growth factor (VEGF) is elevated in diabetic macular edema (DME). Ranibizumab binds to and inhibits multiple VEGF variants. We investigated the safety and efficacy of ranibizumab in DME involving the foveal center....

  20. Sample Exchange Evaluation (SEE) Report - Phase II

    Energy Technology Data Exchange (ETDEWEB)

    Winters, W.I.

    1994-09-28

    This report describes the results from Phase II of the Sample Exchange Evaluation (SEE) Program, a joint effort to compare analytical laboratory performance on samples from the Hanford Site`s high-level waste tanks. In Phase II, the program has been expanded to include inorganic constituents in addition to radionuclides. Results from Phase II that exceeded 20% relative percent difference criteria are identified.

  1. Limited clinical efficacy of azacitidine in transfusion-dependent, growth factor-resistant, low- and Int-1-risk MDS: Results from the nordic NMDSG08A phase II trial

    International Nuclear Information System (INIS)

    Tobiasson, M; Dybedahl, I; Holm, M S; Karimi, M; Brandefors, L; Garelius, H; Grövdal, M; Högh-Dufva, I; Grønbæk, K; Jansson, M; Marcher, C; Nilsson, L; Kittang, A O; Porwit, A; Saft, L; Möllgård, L; Hellström-Lindberg, E

    2014-01-01

    This prospective phase II study evaluated the efficacy of azacitidine (Aza)+erythropoietin (Epo) in transfusion-dependent patients with lower-risk myelodysplastic syndrome (MDS). Patients ineligible for or refractory to full-dose Epo+granulocyte colony stimulation factors for >8 weeks and a transfusion need of ⩾4 units over 8 weeks were included. Aza 75 mg m −2 d −1 , 5/28 days, was given for six cycles; non-responding patients received another three cycles combined with Epo 60 000 units per week. Primary end point was transfusion independence (TI). All patients underwent targeted mutational screen for 42 candidate genes. Thirty enrolled patients received ⩾one cycle of Aza. Ten patients discontinued the study early, 7 due to adverse events including 2 deaths. Thirty-eight serious adverse events were reported, the most common being infection. Five patients achieved TI after six cycles and one after Aza+Epo, giving a total response rate of 20%. Mutational screening revealed a high frequency of recurrent mutations. Although no single mutation predicted for response, SF3A1 (n=3) and DNMT3A (n=4) were only observed in non-responders. We conclude that Aza can induce TI in severely anemic MDS patients, but efficacy is limited, toxicity substantial and most responses of short duration. This treatment cannot be generally recommended in lower-risk MDS. Mutational screening revealed a high frequency of mutations

  2. Efficacy and Tolerability Outcomes of a Phase II, Randomized, Open-Label, Multicenter Study of a New Water-Dispersible Pediatric Formulation of Dihydroartemisinin-Piperaquine for the Treatment of Uncomplicated Plasmodium falciparum Malaria in African Infants.

    Science.gov (United States)

    Gargano, Nicola; Madrid, Lola; Valentini, Giovanni; D'Alessandro, Umberto; Halidou, Tinto; Sirima, Sodiomon; Tshefu, Antoinette; Mtoro, Ali; Gesase, Samwel; Bassat, Quique

    2018-01-01

    Artemisinin combination therapies are considered the mainstay of malaria treatment, but pediatric-friendly formulations for the treatment of infants are scarce. We sought to evaluate the efficacy and safety of a new dispersible-tablet formulation of dihydroartemisinin/piperaquine phosphate (DHA/PQP) in comparison to the marketed tablet (Eurartesim) in the treatment of infants with uncomplicated Plasmodium falciparum malaria. Reported here are the results of a large phase II, randomized, open-label, multicenter trial conducted in African infants (6 to 12 months of age) from Mozambique, Burkina Faso, The Gambia, the Democratic Republic of the Congo, and Tanzania. Primary efficacy endpoint was the PCR-corrected adequate clinical and parasitological response (ACPR) at day 28. Analysis was performed for the intention-to-treat (ITT) and per-protocol (PP) populations. A total of 201 patients received the dispersible-tablet formulation, and 99 received the conventional one administered as crushed tablets. At day 28, the PCR-corrected ACPRs were 86.9% (ITT) and 98.3% (PP) in the dispersible-tablet group and 84.9% (ITT) and 100% (PP) in the crushed-tablet group. At day 42, these values were 85.9% (ITT) and 96.5% (PP) in the dispersible-tablet group and 82.8% (ITT) and 96.4% (PP) in the crushed-tablet group. The comparison between survival curves for time to new infections showed no statistically significant differences ( P = 0.409). The safety and tolerability profile for the two groups was similar in terms of type and frequency of adverse events and was consistent with that expected in African infants with malaria. A standard 3-day treatment with the new dispersible DHA/PQP formulation is as efficacious as the currently used tablet in African infants and has a comparable safety profile. (This trial was registered at ClinicalTrials.gov under registration no. NCT01992900.). Copyright © 2017 Gargano et al.

  3. Phase II clinical development of new drugs

    CERN Document Server

    Ting, Naitee; Ho, Shuyen; Cappelleri, Joseph C

    2017-01-01

    This book focuses on how to appropriately plan and develop a Phase II program, and how to design Phase II clinical trials and analyze their data. It provides a comprehensive overview of the entire drug development process and highlights key questions that need to be addressed for the successful execution of Phase II, so as to increase its success in Phase III and for drug approval. Lastly it warns project team members of the common potential pitfalls and offers tips on how to avoid them.

  4. Centrifuge workers study. Phase II, completion report

    Energy Technology Data Exchange (ETDEWEB)

    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 to 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.

  5. Centrifuge workers study. Phase II, completion report

    International Nuclear Information System (INIS)

    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 to 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

  6. Phase II study to assess the efficacy of conventionally fractionated radiotherapy followed by a stereotactic radiosurgery boost in patients with locally advanced pancreatic cancer

    International Nuclear Information System (INIS)

    Koong, Albert C.; Christofferson, Erin; Le, Quynh-Thu; Goodman, Karyn A.; Ho, Anthony; Kuo, Timothy; Ford, James M.; Fisher, George A.; Greco, Ralph; Norton, Jeffrey; Yang, George P.

    2005-01-01

    Purpose: To determine the efficacy of concurrent 5-fluorouracil (5-FU) and intensity-modulated radiotherapy (IMRT) followed by body stereotactic radiosurgery (SRS) in patients with locally advanced pancreatic cancer. Methods and Materials: In this prospective study, all patients (19) had pathologically confirmed adenocarcinoma and were uniformly staged. Our treatment protocol consisted of 45 Gy IMRT with concurrent 5-FU followed by a 25 Gy SRS boost to the primary tumor. Results: Sixteen patients completed the planned therapy. Two patients experienced Grade 3 toxicity (none had more than Grade 3 toxicity). Fifteen of these 16 patients were free from local progression until death. Median overall survival was 33 weeks. Conclusions: Concurrent IMRT and 5-FU followed by SRS in patients with locally advanced pancreatic cancer results in excellent local control, but does not improve overall survival and is associated with more toxicity than SRS, alone

  7. Efficacy and safety of sorafenib in combination with gemcitabine in patients with advanced hepatocellular carcinoma: a multicenter, open-label, single-arm phase II study.

    Science.gov (United States)

    Srimuninnimit, Vichien; Sriuranpong, Virote; Suwanvecho, Suthida

    2014-09-01

    Currently, the only standard systemic treatment for advanced hepatocellular carcinoma is sorafenib monotherapy. The study was conducted to assess the efficacy and safety of the novel combination of sorafenib and gemcitabine in the treatment of advanced hepatocellular carcinoma. Between March 2008 and October 2010, patients with advanced pathologically proven hepatocellular carcinoma who had not received previous systemic therapy and had Child-Pugh liver function class A or B received sorafenib plus gemcitabine. Treatment included 4-week cycle of gemcitabine (1000 mg/m(2) days 1, 8, 15) to the maximum of six cycles together with sorafenib (400 mg twice daily). Patient continued sorafenib until disease progression or withdrawal from other reasons. The primary end point is progression-free survival. Forty-five patients were enrolled in this study. The median progression-free survival was 3.7 months (95% CI 3.5-3.8). The overall response rate was 4% with no complete responses and the disease control rate was 66%. The median overall survival (OS) was 11.6 months (95% CI 7.4-15.9). The median time to progression was 3.6 months (95% CI 3.4-3.7). The most frequently reported grade 3/4 treatment-related adverse events included thrombocytopenia 33%, neutropenia 16% and hand-foot skin reaction 13%. The study regimen was well tolerated. The combination of sorafenib and gemcitabine in advanced hepatocellular carcinoma is generally well tolerated and has modest clinical efficacy. The median OS is up to 1 year. However, well-designed randomized controlled trials with a sorafenib alone comparator arm are needed to confirm this finding. © 2014 Wiley Publishing Asia Pty Ltd.

  8. Correlation between the Efficacy of Lamotrigine and the Serum Lamotrigine Level during the Remission Phase of Acute Bipolar II Depression: A Naturalistic and Unblinded Prospective Pilot Study.

    Science.gov (United States)

    Kikkawa, Akiyoshi; Kitamura, Yoshihisa; Aiba, Tetsuya; Hiraki, Koichi; Sendo, Toshiaki

    2017-01-01

    Lamotrigine has acute antidepressant effects in patients with bipolar disorder. However, there is little information regarding appropriate serum levels of lamotrigine and the time until remission after the start of lamotrigine therapy in patients with bipolar II depression. This was a naturalistic and unblinded prospective pilot study. Twelve patients' depressive symptoms were evaluated using the Montgomery-Åsberg Depression Rating Scale (MADRS) at the start of treatment and at the time of remission, and blood samples were obtained at the time of remission. Mahalanobis distance was used to analyze the relationship between the MADRS improvement rate and the serum lamotrigine level. Furthermore, we calculated the Spearman's rank correlation coefficient for the relationship between the MADRS improvement rate and the serum lamotrigine level, and produced box plots of the serum lamotrigine level at remission and the time until remission. The Mahalanobis distance for the patient that was co-administered lamotrigine and valproic acid differed significantly from those of the other patients (p<0.001). There was no linear relationship between the serum lamotrigine level and the MADRS improvement rate among the patients that did not receive valproic acid. The median time from the start of lamotrigine therapy until remission was 6 weeks. The serum lamotrigine level does not have an important impact on the acute therapeutic effects of lamotrigine on bipolar II depression. In addition, we consider that different treatment options should be considered for non-responders who do not exhibit any improvement after the administration of lamotrigine for approximately 6 weeks.

  9. Military Family Coping Project - Phase II

    Science.gov (United States)

    2015-05-01

    Anxiety, Life Satisfaction , Addiction, Trauma 4 The Military Family Coping Project reflects two phases. The first consisted of a series of focus...need for and guided the work of the Military Family Coping Project Phase II funded by TATRC. The Military Family Coping Project Phase II was...solidarity. For the purposes of family functioning analyses, married and unmarried soldiers were analyzed separately because marital status affects

  10. Kursk Operation Simulation and Validation Exercise - Phase II (KOSAVE II)

    National Research Council Canada - National Science Library

    Bauman, Walter

    1998-01-01

    ... (KOSAVE) Study (KOSAVE II) documents, in this report a statistical record of the Kursk battle, as represented in the KDB, for use as both a standalone descriptive record for historians, and as a baseline for a subsequent Phase...

  11. Libertas: rationale and study design of a multicentre, Phase II, double-blind, randomised, placebo-controlled investigation to evaluate the efficacy, safety and tolerability of locally applied NRL001 in patients with faecal incontinence.

    Science.gov (United States)

    Siproudhis, L; Jones, D; Shing, R Ng Kwet; Walker, D; Scholefield, J H

    2014-03-01

    Faecal incontinence affects up to 8% of adults. Associated social isolation and subsequent depression can have devastating effects on quality of life (QoL). Faecal incontinence is an underreported health problem as the social isolation and stigma that patients experience makes it difficult for sufferers to discuss their condition with a physician. There have been few well-designed, placebo-controlled clinical trials of treatment for faecal incontinence and little clinical evidence is available to inform the most appropriate management strategies. Libertas, a robustly designed study will investigate the efficacy and safety of NRL001 (1R,2S-methoxamine), an α1 -adrenoceptor agonist, in the treatment of faecal incontinence. Libertas is a multicentre, Phase II, double-blind, randomised, placebo-controlled, parallel group study. Patient recruitment took place across 55 study centres in Europe. Patients suffering with faecal incontinence were randomised into four groups (approximately 110 each) to receive once daily self-administered doses of NRL001 (5, 7.5 or 10 mg or placebo in a suppository formulation) for 8 weeks. The primary objective of Libertas is to assess the impact of once daily administration of NRL001 on the severity and frequency of incontinence episodes as assessed by the Wexner score at 4 weeks, compared with placebo. Secondary outcomes include measures of efficacy of NRL001 compared with placebo following 8 weeks treatment; safety and tolerability; evaluation of plasma pharmacokinetics; establishment of any pharmacokinetic/pharmacodynamic relationship to adverse events; dose-response relationship; the efficacy of NRL001 therapy at 4 and 8 weeks assessed by the Vaizey score; and QoL using the Faecal Incontinence Quality of Life and the EQ-5D-5L Healthcare Questionnaires following 4 and 8 weeks NRL001 therapy. Overall patient satisfaction with the treatment will also be evaluated. This is the first randomised controlled study to investigate the efficacy

  12. Multicentre, open, noncomparative Phase II trial to evaluate the efficacy and tolerability of fotemustine, cisplatin, alpha-interferon and interleukin-2 in advanced melanoma patients.

    Science.gov (United States)

    Ridolfi, Laura; Fiorentini, Giammaria; Guida, Michele; Michiara, Maria; Freschi, Andrea; Aitini, Enrico; Ballardini, Michela; Bichisao, Ettore; Ridolfi, Ruggero

    2009-04-01

    The efficacy and tolerability of fotemustine, cisplatin, alpha-interferon and interleukin-2 biochemotherapy were evaluated in advanced melanoma patients. The schedule consisted of fotemustine (100 mg/m) and cisplatin (75 mg/m) intravenous on day 1, followed by subcutaneous interleukin-2 at a dose of 4.5 MIU on days 3-5 and 8-12 and alpha-interferon at a dose of 3 MU three times/week, every 3 weeks for six cycles. Sixty patients were evaluated for tumour response, 12 of whom had brain metastases (BM). One patient (1.7%) with BM achieved a complete response and partial responses were observed in 10 patients (16.7%), including one BM patient. Overall response rate was 18.4 and 16.6% in BM patients (median response duration 8.2 months). Disease control, defined as overall response and stable disease, was 58.4% in all patients and 75% in patients with BM. Median time to progression was 3.2 months (4.2 months in BM patients). Median overall survival was 8.9 months (7.6 months in BM patients). Toxic events were mild to moderate. This combination was well tolerated and showed acceptable clinical activity, especially in BM patients.

  13. Efficacy and safety of concurrent chemoradiation with weekly cisplatin ± low-dose celecoxib in locally advanced undifferentiated nasopharyngeal carcinoma: a phase II-III clinical trial.

    Science.gov (United States)

    Mohammadianpanah, Mohammad; Razmjou-Ghalaei, Sasan; Shafizad, Amin; Ashouri-Taziani, Yaghoub; Khademi, Bijan; Ahmadloo, Niloofar; Ansari, Mansour; Omidvari, Shapour; Mosalaei, Ahmad; Mosleh-Shirazi, Mohammad Amin

    2011-01-01

    This is the first study that aimed to determine the efficacy and safety of concurrent chemoradiation with weekly cisplatin ± celecoxib 100 mg twice daily in locally advanced undifferentiated nasopharyngeal carcinoma. Eligible patients had newly diagnosed locally advanced (T3-T4, and/or N2-N3, M0) undifferentiated nasopharyngeal carcinoma, no prior therapy, Karnofsky performance status ≥ 70, and normal organ function. The patients were assigned to receive 7 weeks concurrent chemoradiation (70 Gy) with weekly cisplatin 30 mg/m 2 with either celecoxib 100 mg twice daily, (study group, n = 26) or placebo (control group, n = 27) followed by adjuvant combined chemotherapy with cisplatin 70 mg/m 2 on day 1 plus 5-fluorouracil 750 mg/m 2 /d with 8-h infusion on days 1-3, 3-weekly for 3 cycles. Overall clinical response rate was 100% in both groups. Complete and partial clinical response rates were 64% and 36% in the study group and 44% and 56% in the control group, respectively (P > 0.25). The addition of celecoxib to concurrent chemoradiation was associated with improved 2-year locoregional control rate from 84% to 100% (P = 0.039). The addition of celecoxib 100 mg twice daily to concurrent chemoradiation improved 2-year locoregional control rate.

  14. Efficacy and safety of liraglutide 3.0 mg for weight management are similar across races: subgroup analysis across the SCALE and phase II randomized trials.

    Science.gov (United States)

    Ard, J; Cannon, A; Lewis, C E; Lofton, H; Vang Skjøth, T; Stevenin, B; Pi-Sunyer, X

    2016-04-01

    The efficacy and safety of liraglutide 3.0 mg versus placebo, as adjunct to diet and exercise, was evaluated in racial subgroups. This post hoc analysis of pooled data from five double-blind randomized, placebo-controlled trials was conducted in 5325 adults with either a body mass index (BMI) ≥27 kg/m(2) plus ≥1 comorbidity or a BMI ≥30 kg/m(2). Statistical interaction tests evaluated possible treatment effect differences between racial subgroups: white (4496, 84.4%), black/African-American (550, 10.3%), Asian (168, 3.2%) and other (111, 2.1%). Effects of liraglutide 3.0 mg on weight loss, associated metabolic effects and safety profile were generally consistent across racial subgroups. All achieved statistically significant mean weight loss at end-of-treatment with liraglutide 3.0 mg versus placebo: white 7.7% versus 2.3%, black/African-American 6.3% versus 1.4%, Asian 6.3% versus 2.5%, other 7.3% versus 0.49%. Treatment effects on weight and cardiovascular risk markers generally showed no dependence on race (interaction test p > 0.05). Adverse events were similar across racial subgroups. © 2016 John Wiley & Sons Ltd.

  15. Application of the coaxial smart drain in patients with a large air leak following anatomic lung resection: a prospective multicenter phase II analysis of efficacy and safety.

    Science.gov (United States)

    Guerrera, Francesco; Filosso, Pier Luigi; Pompili, Cecilia; Olivetti, Stefania; Roffinella, Matteo; Imperatori, Andrea; Brunelli, Alessandro

    2018-01-01

    The presence of air leak following lung resection remains a frequent problem, which may prolong hospital stay and increase hospital costs. In the past, some studies documented the efficacy of soft and flexible chest tube in patients who underwent thoracic surgery. Nevertheless, safety in case of post-operative large air or liquid leak remains questionable. The objective of this study was to verify through a multicentre study the safety and the effectiveness of the coaxial chest tube in a consecutive series of selected patients who underwent anatomical pulmonary resection and with an active and large air leak. Between October 2016 and September 2017, data from patients submitted to anatomical lung resection with curative intent and operated in two Department of Thoracic Surgery of two different were prospectively collected. The inclusion criteria consisted in the presence of an air leak greater than 50 mL/min measured with a digital drainage system during the 3 postoperative hours. A descriptive statistic was used to report the incidence of complications assumed to be associated with the use of the coaxial drain. Forty-eight consecutive patients (27 males) submitted to lobectomy (37 patients: 77%) or anatomic segmentectomies (11 patients) were included in the analyses. Thirty-four operations (71%) were performed by video-assisted thoracic surgery (VATS). The median duration of chest tubes was 13 days [interquartile range (IQR), 4-19] and the median duration of air leak was 9 days (IQR, 2-17.5). No patient had undrained postoperative pleural effusion judged to require an additional chest tube placement. There were 12 (25%) cases of clinically or radiologically significant surgical emphysema; in none of these patients any additional procedure or re-operation was required, and they were treated conservatively by increasing the level of suction. Our experience with this novel Coaxial Drain was satisfactory with no clinically relevant complication caused using this drain

  16. Application of the coaxial smart drain in patients with a large air leak following anatomic lung resection: a prospective multicenter phase II analysis of efficacy and safety

    Science.gov (United States)

    Filosso, Pier Luigi; Pompili, Cecilia; Olivetti, Stefania; Roffinella, Matteo; Imperatori, Andrea; Brunelli, Alessandro

    2018-01-01

    Background The presence of air leak following lung resection remains a frequent problem, which may prolong hospital stay and increase hospital costs. In the past, some studies documented the efficacy of soft and flexible chest tube in patients who underwent thoracic surgery. Nevertheless, safety in case of post-operative large air or liquid leak remains questionable. The objective of this study was to verify through a multicentre study the safety and the effectiveness of the coaxial chest tube in a consecutive series of selected patients who underwent anatomical pulmonary resection and with an active and large air leak. Methods Between October 2016 and September 2017, data from patients submitted to anatomical lung resection with curative intent and operated in two Department of Thoracic Surgery of two different were prospectively collected. The inclusion criteria consisted in the presence of an air leak greater than 50 mL/min measured with a digital drainage system during the 3 postoperative hours. A descriptive statistic was used to report the incidence of complications assumed to be associated with the use of the coaxial drain. Results Forty-eight consecutive patients (27 males) submitted to lobectomy (37 patients: 77%) or anatomic segmentectomies (11 patients) were included in the analyses. Thirty-four operations (71%) were performed by video-assisted thoracic surgery (VATS). The median duration of chest tubes was 13 days [interquartile range (IQR), 4–19] and the median duration of air leak was 9 days (IQR, 2–17.5). No patient had undrained postoperative pleural effusion judged to require an additional chest tube placement. There were 12 (25%) cases of clinically or radiologically significant surgical emphysema; in none of these patients any additional procedure or re-operation was required, and they were treated conservatively by increasing the level of suction. Conclusions Our experience with this novel Coaxial Drain was satisfactory with no clinically

  17. Phase II Final Scientific/Technical Report

    Energy Technology Data Exchange (ETDEWEB)

    Grigg, Reid; McPherson, Brian; Lee, Rober

    2011-08-01

    The Southwest Regional Partnership on Carbon Sequestration (SWP) one of seven regional partnerships sponsored by the U.S. Department of Energy (USDOE) carried out five field pilot tests in its Phase II Carbon Sequestration Demonstration effort, to validate the most promising sequestration technologies and infrastructure concepts, including three geologic pilot tests and two terrestrial pilot programs. This field testing demonstrated the efficacy of proposed sequestration technologies to reduce or offset greenhouse gas emissions in the region. Risk mitigation, optimization of monitoring, verification, and accounting (MVA) protocols, and effective outreach and communication were additional critical goals of these field validation tests. The program included geologic pilot tests located in Utah, New Mexico, Texas, and a region-wide terrestrial analysis. Each geologic sequestration test site was intended to include injection of a minimum of ~75,000 tons/year CO{sub 2}, with minimum injection duration of one year. These pilots represent medium- scale validation tests in sinks that host capacity for possible larger-scale sequestration operations in the future. These validation tests also demonstrated a broad variety of carbon sink targets and multiple value-added benefits, including testing of enhanced oil recovery and sequestration, enhanced coalbed methane production and a geologic sequestration test combined with a local terrestrial sequestration pilot. A regional terrestrial sequestration demonstration was also carried out, with a focus on improved terrestrial MVA methods and reporting approaches specific for the Southwest region.

  18. HPC Benchmark Suite NMx, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In the phase II effort, Intelligent Automation Inc., (IAI) and University of Central Florida (UCF) propose to develop a comprehensive numerical test suite for...

  19. Murine Automated Urine Sampler (MAUS), Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This SBIR Phase II effort involves the development of a novel rodent spaceflight habitat, focusing on care and monitoring of mice for gravitational physiology...

  20. High Resolution Autostereoscopic Cockpit Display, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — During this Phase II program Dimension Technologies Inc. (DTI) proposes to design and build an autostereoscopic (glasses-free 3D) LCD based aircraft cockpit display...

  1. Pavement performance evaluation, phase II : data collection.

    Science.gov (United States)

    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...

  2. Titanium Heat Pipe Thermal Plane, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The objective of the Phase II program is to complete the development of the titanium heat pipe thermal plane and establish all necessary steps for production of this...

  3. Oxygen-Methane Thruster, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Two main innovations will be developed in the Phase II effort that are fundamentally associated with our gaseous oxygen/gaseous methane RCS thruster. The first...

  4. Innovation in the Sky, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This Phase II proposal presents a scope of work to develop reliable Sense and Avoid for BVLOS Unmanned Aerial Vehicle [UAV] operations. We first analyze a) the...

  5. Crew Cerebral Oxygen Monitor, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This Phase II SBIR proposal is aimed at developing a non-invasive, optical method for monitoring crew member state of awareness in operational environments. All...

  6. Silver Biocide Analysis & Control Device, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Rapid, accurate measurement and process control of silver ion biocide concentrations in future space missions is needed. The purpose of the Phase II program is to...

  7. Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Sandra Hummel

    2018-03-01

    Full Text Available Objective: Women with insulin-requiring gestational diabetes mellitus (GDM are at high risk of developing diabetes within a few years postpartum. We implemented this phase II study to test the hypothesis that vildagliptin, a dipeptidyl peptidase-4 inhibitor, is superior to placebo in terms of reducing the risk of postpartum diabetes. Methods: Women with insulin-requiring GDM were randomized to either placebo or 50 mg vildagliptin twice daily for 24 months followed by a 12-month observation period (EudraCT: 2007-000634-39. Both groups received lifestyle counseling. The primary efficacy outcomes were the diagnosis of diabetes (American Diabetes Association (ADA criteria or impaired fasting glucose (IFG/impaired glucose tolerance (IGT. Results: Between 2008 and 2015, 113 patients (58 vildagliptin, 55 placebo were randomized within 2.2–10.4 (median 8.6 months after delivery. At the interim analysis, nine diabetic events and 28 IFG/IGT events had occurred. Fifty-two women withdrew before completing the treatment phase. Because of the low diabetes rate, the study was terminated. Lifestyle adherence was similar in both groups. At 24 months, the cumulative probability of postpartum diabetes was 3% and 5% (hazard ratio: 1.03; 95% confidence interval: 0.15–7.36 and IFG/IGT was 43% and 22% (hazard ratio: 0.55; 95% confidence interval: 0.26–1.19 in the placebo and vildagliptin groups, respectively. Vildagliptin was well tolerated with no unexpected adverse events. Conclusions: The study did not show significant superiority of vildagliptin over placebo in terms of reducing the risk of postpartum diabetes. However, treatment was safe and suggested some improvements in glycemic control, insulin resistance, and β-cell function. The study identified critical issues in performing clinical trials in the early postpartum period in women with GDM hampering efficacy assessments. With this knowledge, we have set a basis for which properly powered trials could

  8. A phase II study with antioxidants, both in the diet and supplemented, pharmaconutritional support, progestagen, and anti-cyclooxygenase-2 showing efficacy and safety in patients with cancer-related anorexia/cachexia and oxidative stress.

    Science.gov (United States)

    Mantovani, Giovanni; Macciò, Antonio; Madeddu, Clelia; Gramignano, Giulia; Lusso, Maria Rita; Serpe, Roberto; Massa, Elena; Astara, Giorgio; Deiana, Laura

    2006-05-01

    To test the efficacy and safety of an integrated treatment based on a pharmaconutritional support, antioxidants, and drugs, all given orally, in a population of advanced cancer patients with cancer-related anorexia/cachexia and oxidative stress. An open early-phase II study was designed according to the Simon two-stage design. The integrated treatment consisted of diet with high polyphenols content (400 mg), antioxidant treatment (300 mg/d alpha-lipoic acid + 2.7 g/d carbocysteine lysine salt + 400 mg/d vitamin E + 30,000 IU/d vitamin A + 500 mg/d vitamin C), and pharmaconutritional support enriched with 2 cans per day (n-3)-PUFA (eicosapentaenoic acid and docosahexaenoic acid), 500 mg/d medroxyprogesterone acetate, and 200 mg/d selective cyclooxygenase-2 inhibitor celecoxib. The treatment duration was 4 months. The following variables were evaluated: (a) clinical (Eastern Cooperative Oncology Group performance status); (b) nutritional [lean body mass (LBM), appetite, and resting energy expenditure]; (c) laboratory [proinflammatory cytokines and leptin, reactive oxygen species (ROS) and antioxidant enzymes]; (d) quality of life (European Organization for Research and Treatment of Cancer QLQ-C30, Euro QL-5D, and MFSI-SF). From July 2002 to January 2005, 44 patients were enrolled. Of these, 39 completed the treatment and were assessable. Body weight increased significantly from baseline as did LBM and appetite. There was an important decrease of proinflammatory cytokines interleukin-6 (IL-6) and tumor necrosis factor-alpha, and a negative relationship worthy of note was only found between LBM and IL-6 changes. As for quality of life evaluation, there was a marked improvement in the European Organization for Research and Treatment of Cancer QLQ-C30, Euro QL-5D(VAS), and multidimensional fatigue symptom inventory-short form scores. At the end of the study, 22 of the 39 patients were "responders" or "high responders." The minimum required was 21; therefore, the

  9. Efficacy of vildagliptin for prevention of postpartum diabetes in women with a recent history of insulin-requiring gestational diabetes: A phase II, randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Hummel, Sandra; Beyerlein, Andreas; Pfirrmann, Markus; Hofelich, Anna; Much, Daniela; Hivner, Susanne; Bunk, Melanie; Herbst, Melanie; Peplow, Claudia; Walter, Markus; Kohn, Denise; Hummel, Nadine; Kratzsch, Jürgen; Hummel, Michael; Füchtenbusch, Martin; Hasford, Joerg; Ziegler, Anette-G

    2018-03-01

    Women with insulin-requiring gestational diabetes mellitus (GDM) are at high risk of developing diabetes within a few years postpartum. We implemented this phase II study to test the hypothesis that vildagliptin, a dipeptidyl peptidase-4 inhibitor, is superior to placebo in terms of reducing the risk of postpartum diabetes. Women with insulin-requiring GDM were randomized to either placebo or 50 mg vildagliptin twice daily for 24 months followed by a 12-month observation period (EudraCT: 2007-000634-39). Both groups received lifestyle counseling. The primary efficacy outcomes were the diagnosis of diabetes (American Diabetes Association (ADA) criteria) or impaired fasting glucose (IFG)/impaired glucose tolerance (IGT). Between 2008 and 2015, 113 patients (58 vildagliptin, 55 placebo) were randomized within 2.2-10.4 (median 8.6) months after delivery. At the interim analysis, nine diabetic events and 28 IFG/IGT events had occurred. Fifty-two women withdrew before completing the treatment phase. Because of the low diabetes rate, the study was terminated. Lifestyle adherence was similar in both groups. At 24 months, the cumulative probability of postpartum diabetes was 3% and 5% (hazard ratio: 1.03; 95% confidence interval: 0.15-7.36) and IFG/IGT was 43% and 22% (hazard ratio: 0.55; 95% confidence interval: 0.26-1.19) in the placebo and vildagliptin groups, respectively. Vildagliptin was well tolerated with no unexpected adverse events. The study did not show significant superiority of vildagliptin over placebo in terms of reducing the risk of postpartum diabetes. However, treatment was safe and suggested some improvements in glycemic control, insulin resistance, and β-cell function. The study identified critical issues in performing clinical trials in the early postpartum period in women with GDM hampering efficacy assessments. With this knowledge, we have set a basis for which properly powered trials could be performed in women with recent GDM. TRIAL REGISTRATION

  10. Licensee Performance Evaluation: Phase II

    International Nuclear Information System (INIS)

    Chakoff, H.E.; Speaker, D.M.; Thompson, S.R.; Cohen, S.C.

    1979-08-01

    This report details work performed during the second phase of a two-phase contract to develop methodology for Licensee Performance Evaluation. The Phase I report, NUREG/CR-0110 details initial efforts on the contract. The model developed in Phase I was used to evaluate nine additional facilities for this report. Performance indicators from noncompliance data were also evaluated. Methodology was developed employing the noncompliance indicators and used for 12 case studies. It was found that licensee event report indicators could be more easily identified and utilized than noncompliance indicators based on presently available data systems. However, noncompliance data, appropriately related to cause, could provide real insight into why performance was what it was

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

    Science.gov (United States)

    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.

  12. Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II: A Phase II Randomized Trial.

    Science.gov (United States)

    Okonkwo, David O; Shutter, Lori A; Moore, Carol; Temkin, Nancy R; Puccio, Ava M; Madden, Christopher J; Andaluz, Norberto; Chesnut, Randall M; Bullock, M Ross; Grant, Gerald A; McGregor, John; Weaver, Michael; Jallo, Jack; LeRoux, Peter D; Moberg, Dick; Barber, Jason; Lazaridis, Christos; Diaz-Arrastia, Ramon R

    2017-11-01

    A relationship between reduced brain tissue oxygenation and poor outcome following severe traumatic brain injury has been reported in observational studies. We designed a Phase II trial to assess whether a neurocritical care management protocol could improve brain tissue oxygenation levels in patients with severe traumatic brain injury and the feasibility of a Phase III efficacy study. Randomized prospective clinical trial. Ten ICUs in the United States. One hundred nineteen severe traumatic brain injury patients. Patients were randomized to treatment protocol based on intracranial pressure plus brain tissue oxygenation monitoring versus intracranial pressure monitoring alone. Brain tissue oxygenation data were recorded in the intracranial pressure -only group in blinded fashion. Tiered interventions in each arm were specified and impact on intracranial pressure and brain tissue oxygenation measured. Monitors were removed if values were normal for 48 hours consecutively, or after 5 days. Outcome was measured at 6 months using the Glasgow Outcome Scale-Extended. A management protocol based on brain tissue oxygenation and intracranial pressure monitoring reduced the proportion of time with brain tissue hypoxia after severe traumatic brain injury (0.45 in intracranial pressure-only group and 0.16 in intracranial pressure plus brain tissue oxygenation group; p injury after severe traumatic brain injury based on brain tissue oxygenation and intracranial pressure values was consistent with reduced mortality and increased proportions of patients with good recovery compared with intracranial pressure-only management; however, the study was not powered for clinical efficacy. Management of severe traumatic brain injury informed by multimodal intracranial pressure and brain tissue oxygenation monitoring reduced brain tissue hypoxia with a trend toward lower mortality and more favorable outcomes than intracranial pressure-only treatment. A Phase III randomized trial to assess

  13. Test of GERDA Phase II detector assembly

    Energy Technology Data Exchange (ETDEWEB)

    Bode, Tobias; Gusev, Konstantin [Technische Universitaet Muenchen (Germany); Schwingenheuer, Bernhard; Wagner, Victoria [Max-Planck Institut fuer Kernphysik, Heidelberg (Germany); Collaboration: GERDA-Collaboration

    2014-07-01

    The GERDA experiment searches for the lepton number violating neutrinoless double beta decay (0νββ) of {sup 76}Ge. The experiment uses HPGe detectors enriched in {sup 76}Ge as source and detection material. In GERDA Phase I five BEGe detectors were operated successfully. These detectors are distinguished for improved energy resolution and enhanced pulse shape discrimination (PSD) against background events. In Phase II additional 25 BEGe detectors will be installed. New electronics and radio-pure low-mass holders were specially designed for Phase II. Prior to the installation in GERDA all BEGe detectors are tested in their final assembly in the LNGS underground laboratory. This talk presents the mechanics and performance of the GERDA Phase II detector assembly.

  14. Upgrades for GERDA Phase II

    Science.gov (United States)

    Heisel, Mark

    2014-09-01

    The Germanium Detector Array (GERDA) experiment is searching for the neutrinoless double beta decay (0 νββ) of 76Ge. It is a process that violates lepton number conservation and is predicted to occur in extensions of the standard model of particle physics. GERDA is located underground in the Gran Sasso National Laboratory (LNGS), Italy. An array of bare high-purity germanium detectors enriched in 76Ge is operated in a cryostat with 64 m3 of liquid argon supplemented by a 3 m thick shield of water. The experiment aims at exploring the 0 νββ decay up to a half life of 2 .1026 yr in two phases: Phase I of the experiment has been concluded last year. No signal is observed and the so far best limit is derived for the half life of the 0 νββ decay of 76Ge, T1/20ν GERDA) experiment is searching for the neutrinoless double beta decay (0 νββ) of 76Ge. It is a process that violates lepton number conservation and is predicted to occur in extensions of the standard model of particle physics. GERDA is located underground in the Gran Sasso National Laboratory (LNGS), Italy. An array of bare high-purity germanium detectors enriched in 76Ge is operated in a cryostat with 64 m3 of liquid argon supplemented by a 3 m thick shield of water. The experiment aims at exploring the 0 νββ decay up to a half life of 2 .1026 yr in two phases: Phase I of the experiment has been concluded last year. No signal is observed and the so far best limit is derived for the half life of the 0 νββ decay of 76Ge, T1/20 ν GERDA Collaboration.

  15. Efficacy and Safety of Low-Dose-Rate Endorectal Brachytherapy as a Boost to Neoadjuvant Chemoradiation in the Treatment of Locally Advanced Distal Rectal Cancer: A Phase-II Clinical Trial.

    Science.gov (United States)

    Omidvari, Shapour; Zohourinia, Shadi; Ansari, Mansour; Ghahramani, Leila; Zare-Bandamiri, Mohammad; Mosalaei, Ahmad; Ahmadloo, Niloofar; Pourahmad, Saeedeh; Nasrolahi, Hamid; Hamedi, Sayed Hasan; Mohammadianpanah, Mohammad

    2015-08-01

    Despite advances in rectal cancer treatment over the last decade, local control and risk of late side effects due to external beam radiation therapy (EBRT) remain as concerns. The present study aimed to investigate the efficacy and the safety of low-dose-rate endorectal brachytherapy (LDRBT) as a boost to neoadjuvant chemoradiation for use in treating locally advanced distal rectal adenocarcinomas. This phase-II clinical trial included 34 patients (as the study arm) with newly diagnosed, locally advanced (clinical T3-T4 and/or N1/N2, M0) lower rectal cancer. For comparative analysis, 102 matched patients (as the historical control arm) with rectal cancer were also selected. All the patients were treated with LDRBT (15 Gy in 3 fractions) and concurrent chemoradiation (45-50.4 Gy). Concurrent chemotherapy consisted of oxaliplatin 130 mg/m(2) intravenously on day 1 plus oral capecitabine 825 mg/m(2) twice daily during LDRBT and EBRT. The study results revealed a significant differences between the study arm and the control arm in terms in the pathologic tumor size (2.1 cm vs. 3.6 cm, P = 0.001), the pathologic tumor stage (35% T3-4 vs. 65% T3-4, P = 0.003), and the pathologic complete response (29.4% vs. 11.7%, P < 0.028). Moreover, a significantly higher dose of EBRT (P = 0.041) was found in the control arm, and a longer time to surgery was observed in the study arm (P < 0.001). The higher rate of treatment-related toxicities, such as mild proctitis and anemia, in the study arm was tolerable and easily manageable. A boost of LDRBT can optimize the pathologic complete response, with acceptable toxicities, in patients with distal rectal cancer.

  16. A phase II, randomized, single-blinded, placebo-controlled clinical trial on the efficacy of Curcumina and Calendula suppositories for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome type III.

    Science.gov (United States)

    Morgia, Giuseppe; Russo, Giorgio Ivan; Urzì, Daniele; Privitera, Salvatore; Castelli, Tommaso; Favilla, Vincenzo; Cimino, Sebastiano

    2017-06-30

    The management of chronic prostatitis/ chronic pelvic pain syndrome type III (CP/CPPS) has been always considered complex due to several biopsychological factors underling the disease. In this clinical study, we aimed to evaluate the efficacy of the treatment with Curcumin and Calendula extract in patients with CP/CPPS III. From June 2015 to January 2016 we enrolled 60 consecutive patients affected by CP/CPPS III in our institution. Patients between 20 and 50 year of age with symptoms of pelvic pain for 3 months or more before study, a total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score ≥ 15 point and diagnosed with NIH category III. Patients were then allocated to receive placebo (Group A) or treatment (Group B). Treatment consisted of rectal suppositories of Curcumin extract 350 mg (95%) and Calendula extract 80 mg (1 suppository/die for 1 month). Patients of Group B received 1 suppository/die for 1 month of placebo. The primary endpoint of the study was the reduction of NIH-CPSI. The secondary outcomes were the change of peak flow, IIEF-5, VAS score and of premature ejaculation diagnostic tool (PEDT). A total of 48 patients concluded the study protocol. The median age of the all cohort was 32.0 years, the median NIH-CPSI was 20.5, the median IIEF-5 was 18.5, the median PEDT was 11.0, the median VAS score was 7.5 and the median peak flow was 14.0. After 3 months of therapy in group A we observed a significant improvement of NIH-CPSI (-5.5; p < 0.01), IIEF-5 (+ 3.5; p < 0.01), PEDT (-6.5; p < 0.01), peak flow (+2.8; p < 0.01) and VAS (-6.5; p < 0.01) with significant differences over placebo group (all p-value significant). In this phase II clinical trial we showed the clinical efficacy of the treatment with Curcumin and Calendula in patients with CP/CPPS III. The benefits of this treatment could be related to the reduction of inflammatory cytokines and of inflammatory cells. These results should be confirmed in further studies

  17. A phase II, randomized, single-blinded, placebo-controlled clinical trial on the efficacy of Curcumina and Calendula suppositories for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome type III

    Directory of Open Access Journals (Sweden)

    Giuseppe Morgia

    2017-06-01

    Full Text Available Objective: The management of chronic prostatitis/ chronic pelvic pain syndrome type III (CP/CPPS has been always considered complex due to several biopsychological factors underling the disease. In this clinical study, we aimed to evaluate the efficacy of the treatment with Curcumin and Calendula extract in patients with CP/CPPS III. Material and methods: From June 2015 to January 2016 we enrolled 60 consecutive patients affected by CP/CPPS III in our institution. Patients between 20 and 50 year of age with symptoms of pelvic pain for 3 months or more before study, a total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI score ≥ 15 point and diagnosed with NIH category III. Patients were then allocated to receive placebo (Group A or treatment (Group B. Treatment consisted of rectal suppositories of Curcumin extract 350 mg (95% and Calendula extract 80 mg (1 suppository/die for 1 month. Patients of Group B received 1 suppository/die for 1 month of placebo. The primary endpoint of the study was the reduction of NIH-CPSI. The secondary outcomes were the change of peak flow, IIEF-5, VAS score and of premature ejaculation diagnostic tool (PEDT. Results: A total of 48 patients concluded the study protocol. The median age of the all cohort was 32.0 years, the median NIH-CPSI was 20.5, the median IIEF-5 was 18.5, the median PEDT was 11.0, the median VAS score was 7.5 and the median peak flow was 14.0. After 3 months of therapy in group A we observed a significant improvement of NIH-CPSI (-5.5; p < 0.01, IIEF-5 (+ 3.5; p < 0.01, PEDT (-6.5; p < 0.01, peak flow (+2.8; p < 0.01 and VAS (-6.5; p < 0.01 with significant differences over placebo group (all p-value significant. Conclusions: In this phase II clinical trial we showed the clinical efficacy of the treatment with Curcumin and Calendula in patients with CP/CPPS III. The benefits of this treatment could be related to the reduction of inflammatory cytokines and of

  18. Phase II study of tolerance and efficacy of hyperfractionated radiotherapy and 5-fluorouracil, cisplatin, and paclitaxel (Taxol) in stage III and IV inoperable and/or unresectable head-and-neck squamous cell carcinoma: A-2 protocol

    International Nuclear Information System (INIS)

    Abitbol, Andre; Abdel-Wahab, May; Lewin, Alan; Troner, Michael; Rodrigues, Maria-Amelia; Hamilton-Nelson, Kara L.; Markoe, Arnold

    2002-01-01

    Purpose: To determine the toxicity and efficacy of concurrent 5-fluorouracil (5-FU), cisplatin, and paclitaxel (Taxol) and hyperfractionated radiotherapy in locally advanced squamous cell carcinoma of the head and neck. Methods and Materials: Twenty-seven patients were entered into this Phase II trial. Eligible patients had Stage III or IV head-and-neck squamous cell carcinoma arising from the oral cavity, hypopharynx, oropharynx, nasopharynx, or larynx. The plan of treatment consisted of hyperfractionated radiotherapy (74.4 Gy at twice daily fractions of 1.2 Gy). Chemotherapy was given on Weeks 1, 5, and 8 as follows: 5-FU at 750 mg/m 2 as a constant infusion for 24 h for 3 days; cisplatin at 50 mg/m 2 in 250-500 mL D5 0.5 NS or NS infusion during 2-4 h, and paclitaxel at 70 mg/m 2 infused in 500 mL NS during 3 h. Results: The overall survival rate of the entire group was 81.5%, 66.7%, and 63% at 1, 2, and 3 years, respectively. The median follow-up was 40.2 months (range 30-62). Of the 27 patients, 19 (70%) had a complete response and an overall survival rate of 100% at 1 year and 94% at 2 and 3 years. The disease-free survival rate of the latter group was 95% at 1 year and 84% at 2 and 3 years. Of the 27 patients, 18 (67%) maintained the complete response until the last follow-up visit or death. Percutaneous endoscopic gastrostomy dependency occurred for a median of 7.1 months. Grade 3 and 4 mucositis occurred in 20 and 3 patients, respectively. Six patients were hospitalized for leukopenic fever. Late toxicities included L'Hermitte syndrome (n=3), osteoradionecrosis (n=1), hypothyroidism (n=4), paresthesias (n=1), aspiration pneumonia (n=3), and esophageal strictures (8 patients underwent dilation). Conclusion: Combining hyperfractionated radiotherapy concurrently with 5-FU, cisplatin, and paclitaxel results in acceptable efficacy and toxicity. However, although a locoregional control benefit is suggested by the preliminary results of this trial, it needs to be

  19. Status of the Gerda phase II experiment

    Energy Technology Data Exchange (ETDEWEB)

    Lazzaro, Andrea [Physik-Department and Excellence Cluster Universe, Technische Universitaet Muenchen (Germany); Collaboration: GERDA-Collaboration

    2016-07-01

    The Gerda experiment searches for the neutrinoless double beta decay (0νββ) in {sup 76}Ge. The first phase of the experiment collected 21.6 kg. yr of exposure with a background index (BI) of 0.01 cts/(keV . kg . yr). No signal was observed and a lower limit for the 0νββ half-life was set to T{sup 0νββ}{sub 1/2} < 2.1 . 10{sup 25} yr (90% C.L). The apparatus has now been upgraded to the Phase II configuration. In Phase II 38 kg of HPGe detectors will be operated to reach an exposure of 100 kg . yr. The goal of Gerda Phase II is to lower the BI to 10{sup -3} cts/(keV . kg . y), in order to reach the sensitivity for T{sup 0νββ}{sub 1/2} = O(10{sup 26}) yr. The additional target mass is constituted of 30 custom made BEGe detectors with higher energy resolution and better pulse shape discrimination performance. The detectors are operated in new radio-pure low-mass holders. The liquid argon surrounding the detectors has been instrumented to veto the background events which produce scintillation light. In this talk the current status and the performance of the Gerda Phase II are presented.

  20. Toward an Integrated Psychological Approach - Phase II

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

    Trauma, Development and Peacebuilding : Toward an Integrated Psychological Approach - Phase II. Over the past decade, the peace, conflict and development community has begun to question the value of medicalized approaches such as post-traumatic stress disorder (PTSD) in dealing with aftermath of political violence ...

  1. LHC Experiments Phase II - TDRs Approval Process

    CERN Document Server

    Forti, F

    2017-01-01

    The overall review process and steps of Phase II were described in CERN-LHCC-2015-077. As experiments submit detailed technical design reports (TDRs), the LHCC and UCG work in close connection to ensure a timely review of the scientific and technical feasibility as well as of the budget and schedule of the upgrade programme.

  2. Feasibility of protein-sparing modified fast by tube (ProMoFasT) in obesity treatment: a phase II pilot trial on clinical safety and efficacy (appetite control, body composition, muscular strength, metabolic pattern, pulmonary function test).

    Science.gov (United States)

    Sukkar, S G; Signori, A; Borrini, C; Barisione, G; Ivaldi, C; Romeo, C; Gradaschi, R; Machello, N; Nanetti, E; Vaccaro, A L

    2013-01-01

    Anecdotal data in the last few years suggest that protein-sparing modified diet (PSMF) delivered by naso-gastric tube enteral (with continuous feeding) could attain an significant weight loss and control of appetite oral feeding, but no phase II studies on safety and efficacy have been done up to now. To verify the safety and efficacy of a protein-sparing modified fast administered by naso-gastric tube (ProMoFasT) for 10 days followed by 20 days of a low-calorie diet, in patients with morbid obesity (appetite control, fat free mass maintenance, pulmonary function tests and metabolic pattern, side effects), 26 patients with a BMI ≥30 kg/m 2 have been selected. The patients had to follow a protein-sparing fast by enteral nutrition (ProMoFasT) for 24 h/day, for 10 days followed by 20 days of low-calorie diet (LCD). The endpoint was represented by body weight, BMI, abdominal circumference, Haber's appetite test, body composition by body impedance assessment (BIA), handgrip strength test, metabolic pattern, pulmonary function test. Safety was assessed by evaluation of complications and side effects of PSMF and/or enteral nutrition. In this report the results on safety and efficacy are described after 10 and 30 days of treatment. After the recruiting phase, a total of 22 patients out of 26 enrolled [14 (63.6 %) females] were evaluated in this study. Globally almost all clinical parameters changed significantly during first 10 days. Total body weight significantly decreased after 10 days (∆-6.1 ± 2; p  < 0.001) and this decrease is maintained in the following 20 days of LCD (∆ = -5.88 ± 1.79; p  < 0.001). Also the abdominal circumference significantly decreased after 10 days [median (range): -4.5 (-30 to 0); p  < 0.001] maintained then in the following 20 days of LCD [median (range) = -7 (-23.5 to -2); p  < 0.001]. All BIA parameters significantly changed after 10 and 30 days from baseline. All parameters except BF had a significant

  3. First results from GERDA Phase II

    Science.gov (United States)

    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.; 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.; 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.; 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.; Zuber, K.; Zuzel, G.

    2017-09-01

    Gerda is designed for a background-free search of 76Ge neutrinoless double-β decay, using bare Ge detectors in liquid Ar. The experiment was upgraded after the successful completion of Phase I to double the target mass and further reduce the background. Newly-designed Ge detectors were installed along with LAr scintillation sensors. Phase II of data-taking started in Dec 2015 with approximately 36 kg of Ge detectors and is currently ongoing. The first results based on 10.8 kg· yr of exposure are presented. The background goal of 10-3 cts/(keV· kg· yr) is achieved and a search for neutrinoless double-β decay is performed by combining Phase I and II data. No signal is found and a new limit is set at T1/20ν > 5.3 \\cdot {1025} yr (90% C.L.).

  4. 129I Interlaboratory comparison: phase I and phase II

    International Nuclear Information System (INIS)

    Caffee, M. W.; Roberts, M. L.

    1999-01-01

    An interlaboratory comparison exercise for 129 I was organized and conducted. Nine laboratories participated in the exercise to either a full or limited extent. In Phase I of the comparison, 11 samples were measured. The suite of samples contained both synthetic ''standard type'' materials (i.e., AgI) and environmental materials. The isotopic 129 I/ 127 I ratios of the samples varied from 10 -8 to 10 -14 . In this phase, each laboratory was responsible for its own chemical preparation of the samples. In Phase I, the 129 I AMS measurements for prepared AgI were in good agreement. However, large discrepancies were seen in 129 I AMS measurements of environmental samples. Because of the large discrepancies seen in the Phase I 129 I intercomparison, a subsequent study was conducted. In Phase II of the 129 I intercomparison, three separate laboratories prepared AgI from two environmental samples (IAEA 375 soil and maples leaves). Each laboratory used its own chemical preparation method with each of the methods being distinctly different. The resulting six samples (two sets of three) were then re-distributed to the participating 129 I AMS facilities and 129 I/ 127 I ratios measured. Results and discussion of both the Phase I and Phase II interlaboratory comparison are presented

  5. The Gerda Phase II detector assembly

    Energy Technology Data Exchange (ETDEWEB)

    Bode, Tobias; Schoenert, Stefan [Physik-Department E15, Technische Universitaet Muenchen (Germany); Schwingenheuer, Bernhard [Max-Planck-Institut fuer Kernphysik, Heidelberg (Germany); Collaboration: GERDA-Collaboration

    2013-07-01

    Phase II of the Gerda (Germanium Detector Array) experiment will continue the search for the neutrinoless double beta decay (0νββ) of {sup 76}Ge. Prerequisites for Phase II are an increased target mass and a reduced background index of < 10 {sup -3} cts/(keV.kg.yr). Major hardware upgrades to achieve these requirements are scheduled for 2013. They include the deployment of a new radio pure low mass detector assembly. The structural properties of available radio-pure materials and reduction of mass necessitate a change of the electrical contacting used to bias and read-out the detectors. The detector assembly design and the favored contacting solution are presented.

  6. 78 FR 76789 - Additional Connect America Fund Phase II Issues

    Science.gov (United States)

    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...

  7. Status of the GERDA Phase II upgrade

    Energy Technology Data Exchange (ETDEWEB)

    Wagner, Victoria [Max-Planck-Insitut für Kernphysik, Heidelberg (Germany)

    2016-06-21

    The GERDA experiment is designed to search for neutrinoless double beta (0νββ) decay of {sup 76}Ge. In Phase I of the experiment a background index of 10{sup −2} cts/(keV·kg·yr) was reached. A lower limit on the half-life of the 0νββ decay of {sup 76}Ge was set to 2.1·10{sup 25} yr (at 90% C.L.). The aim of Phase II is to reach a sensitivity of the half-life of about 10{sup 26} yr. To increase the exposure thirty new Broad Energy Germanium (BEGe) detectors have been produced. These detectors are distinct for their improved energy resolution and enhanced pulse shape discrimination of signal from background events. Further background reduction will be reached by a light instrumentation to read out argon scintillation light. In April 2015 the light instrumentation together with eight BEGe detectors has been successfully deployed in the GERDA cryostat. In a commissioning run it was shown that two of the major background components, external γ-rays from {sup 214}Bi and {sup 208}Tl decays, were suppressed up to two orders of magnitude. We are confident to reach a background index of 10{sup −3} cts/(keV·kg·yr) which is the design goal for GERDA Phase II.

  8. Status of the GERDA Phase II upgrade

    Science.gov (United States)

    Wagner, Victoria

    2016-06-01

    The GERDA experiment is designed to search for neutrinoless double beta (0νββ) decay of 76Ge. In Phase I of the experiment a background index of 10-2 cts/(keV.kg.yr) was reached. A lower limit on the half-life of the 0νββ decay of 76Ge was set to 2.1.1025 yr (at 90% C.L.). The aim of Phase II is to reach a sensitivity of the half-life of about 1026 yr. To increase the exposure thirty new Broad Energy Germanium (BEGe) detectors have been produced. These detectors are distinct for their improved energy resolution and enhanced pulse shape discrimination of signal from background events. Further background reduction will be reached by a light instrumentation to read out argon scintillation light. In April 2015 the light instrumentation together with eight BEGe detectors has been successfully deployed in the GERDA cryostat. In a commissioning run it was shown that two of the major background components, external γ-rays from 214Bi and 208Tl decays, were suppressed up to two orders of magnitude. We are confident to reach a background index of 10-3 cts/(keV.kg.yr) which is the design goal for GERDA Phase II.

  9. Status of the GERDA Phase II upgrade

    International Nuclear Information System (INIS)

    Wagner, Victoria

    2016-01-01

    The GERDA experiment is designed to search for neutrinoless double beta (0νββ) decay of "7"6Ge. In Phase I of the experiment a background index of 10"−"2 cts/(keV·kg·yr) was reached. A lower limit on the half-life of the 0νββ decay of "7"6Ge was set to 2.1·10"2"5 yr (at 90% C.L.). The aim of Phase II is to reach a sensitivity of the half-life of about 10"2"6 yr. To increase the exposure thirty new Broad Energy Germanium (BEGe) detectors have been produced. These detectors are distinct for their improved energy resolution and enhanced pulse shape discrimination of signal from background events. Further background reduction will be reached by a light instrumentation to read out argon scintillation light. In April 2015 the light instrumentation together with eight BEGe detectors has been successfully deployed in the GERDA cryostat. In a commissioning run it was shown that two of the major background components, external γ-rays from "2"1"4Bi and "2"0"8Tl decays, were suppressed up to two orders of magnitude. We are confident to reach a background index of 10"−"3 cts/(keV·kg·yr) which is the design goal for GERDA Phase II.

  10. LAr instrumentation for Gerda phase II

    Energy Technology Data Exchange (ETDEWEB)

    Wegmann, Anne [Max-Planck-Institut fuer Kernphysik, Heidelberg (Germany); Collaboration: GERDA-Collaboration

    2015-07-01

    Gerda is an experiment to search for the neutrinoless double beta decay of {sup 76}Ge. Results of Phase I have been published in summer 2013. Currently the commissioning of Gerda Phase II is ongoing. To reach the aspired background index of ≤10{sup -3} cts/(keV.kg.yr) active background-suppression techniques will be applied, including an active liquid argon veto (LAr veto). It has been demonstrated by the LArGe test facility that the detection of argon scintillation light can be used to effectively suppress background events in the germanium, which simultaneously deposit energy in LAr. The light instrumentation consisting of photomultiplier tubes (PMT) and wavelength-shifting fibers connected to silicon multipliers (SiPM) has been installed in Gerda. In this talk the low background design of the LAr veto and its performance during the commissioning runs are reported.

  11. Performance of GERDA phase II BEGe detectors

    Energy Technology Data Exchange (ETDEWEB)

    Wagner, Victoria [Max-Planck Institut fuer Kernphysik (Germany); Collaboration: GERDA-Collaboration

    2015-07-01

    The GERDA experiment searches for the lepton number violating neutrinoless double beta (0νββ) decay of {sup 76}Ge. GERDA uses HPGe detectors enriched in {sup 76}Ge as source and detection material. The experiment proceeds in two phases. In Phase I a background index of 10{sup -2} cts/(keV.kg.yr) was reached and a new lower limit on the half-life of the 0νββ decay of {sup 76}Ge was set to 2.1.10{sup 25} yr (at 95% C.L.). In Phase II the background index will be lowered by an order of magnitude and a sensitivity of 10{sup 26} yr will be reached. In order to achieve this goal 30 new custom-made broad energy germanium (BEGe) detectors and a liquid argon scintillation light veto will be deployed. Five BEGe detectors have been operated successfully in Phase I and demonstrated their improved energy resolution and enhanced pulse shape discrimination (PSD) against background events. Special designed electronics will further improve energy resolution and PSD performance. The first results from commissioning of the new BEGe detectors are presented in this talk.

  12. Pretest Predictions for Phase II Ventilation Tests

    International Nuclear Information System (INIS)

    Yiming Sun

    2001-01-01

    The objective of this calculation is to predict the temperatures of the ventilating air, waste package surface, and concrete pipe walls that will be developed during the Phase II ventilation tests involving various test conditions. The results will be used as inputs to validating numerical approach for modeling continuous ventilation, and be used to support the repository subsurface design. The scope of the calculation is to identify the physical mechanisms and parameters related to thermal response in the Phase II ventilation tests, and describe numerical methods that are used to calculate the effects of continuous ventilation. The calculation is limited to thermal effect only. This engineering work activity is conducted in accordance with the ''Technical Work Plan for: Subsurface Performance Testing for License Application (LA) for Fiscal Year 2001'' (CRWMS M and O 2000d). This technical work plan (TWP) includes an AP-2.21Q, ''Quality Determinations and Planning for Scientific, Engineering, and Regulatory Compliance Activities'', activity evaluation (CRWMS M and O 2000d, Addendum A) that has determined this activity is subject to the YMP quality assurance (QA) program. The calculation is developed in accordance with the AP-3.12Q procedure, ''Calculations''. Additional background information regarding this activity is contained in the ''Development Plan for Ventilation Pretest Predictive Calculation'' (DP) (CRWMS M and O 2000a)

  13. Spray Forming Aluminum - Final Report (Phase II)

    Energy Technology Data Exchange (ETDEWEB)

    D. D. Leon

    1999-07-08

    The U.S. Department of Energy - Office of Industrial Technology (DOE) has an objective to increase energy efficient and enhance competitiveness of American metals industries. To support this objective, ALCOA Inc. entered into a cooperative program to develop spray forming technology for aluminum. This Phase II of the DOE Spray Forming Program would translate bench scale spray forming technology into a cost effective world class process for commercialization. Developments under DOE Cooperative Agreement No. DE-FC07-94ID13238 occurred during two time periods due to budgetary constraints; April 1994 through September 1996 and October 1997 and December 1998. During these periods, ALCOA Inc developed a linear spray forming nozzle and specific support processes capable of scale-up for commercial production of aluminum sheet alloy products. Emphasis was given to alloys 3003 and 6111, both being commercially significant alloys used in the automotive industry. The report reviews research performed in the following areas: Nozzel Development, Fabrication, Deposition, Metal Characterization, Computer Simulation and Economics. With the formation of a Holding Company, all intellectual property developed in Phases I and II of the Project have been documented under separate cover for licensing to domestic producers.

  14. Phase II study of biweekly cetuximab in combination with irinotecan as second-line treatment in patients with platinum-resistant gastro-oesophageal cancer

    DEFF Research Database (Denmark)

    Schønnemann, K R; Yilmaz, Mette Karen; Bjerregaard, J K

    2012-01-01

    The purpose of this phase II trial was to evaluate the efficacy and safety of cetuximab and irinotecan as second-line treatment in patients with gastro-oesophageal adenocarcinoma.......The purpose of this phase II trial was to evaluate the efficacy and safety of cetuximab and irinotecan as second-line treatment in patients with gastro-oesophageal adenocarcinoma....

  15. Efficacy and tolerability of concurrent weekly low dose cisplatin during radiation treatment of localised muscle invasive bladder transitional cell carcinoma: A report of two sequential Phase II studies from the Trans Tasman Radiation Oncology Group

    International Nuclear Information System (INIS)

    Gogna, Nirdosh Kumar; Matthews, John H.L.; Turner, Sandra L.; Mameghan, Heidi; Duchesne, Gillian M.; Spry, Nigel; Berry, Martin P.; Keller, Jacqui; Tripcony, Lee

    2006-01-01

    Background and purpose: To determine the feasibility, toxicity, and clinical effectiveness of concurrent weekly cisplatin chemotherapy in conjunction with definitive radiation in the treatment of localised muscle invasive bladder cancer. Patients and methods: In January 1997 the Trans Tasman Radiation Oncology Group embarked on a Phase II study (TROG 97.01) of weekly cisplatin (35 mg/m 2 x 7 doses) plus radiation to a dose of 63 Gy over 7 weeks. Following an interim toxicity analysis, the dose intensity of cisplatin was reduced to 6 cycles and the radiation schedule changed to 64 Gy over 6.5 weeks leading to the second study (TROG 99.06). A total of 113 patients were enrolled. Results: Acute grade 3 urinary toxicity occurred in 23% of the patients. Acute grade 4 pelvic toxicity was not seen. Thirty-eight patients (33%) experienced grade 3 or 4 cisplatin related toxicities with 15 patients (12%) requiring significant dose modification. The reduced dose intensity in Study 99.06 improved tolerability. Incidence of significant late morbidity was low (6%). Seventy-nine patients (70%) achieved complete remission at the 6 month cystoscopic assessment. Local invasive recurrence was seen in 11 of the 79 patients (14%). In 18 patients (16%) isolated superficial TCC/CIS were detected (6 months and beyond).The local control rate was 45% with a functional bladder being retained in 69 of the 113 patients (61%). RFS and DSS at 5 years were 33% and 50%, respectively. Conclusion: Our two sequential Phase II studies have shown that concurrent chemoradiation using weekly cisplatin in the management of localised invasive bladder TCC is feasible and reasonably well tolerated. This approach is currently being investigated further in a randomised study

  16. Phase-II Associative Memory ASIC Specifications

    CERN Document Server

    Stabile, Alberto; Warren, Matthew; Green, Barry; Konstantinidis, Nikolaos; Motuk, Halil Erdem; Frontini, Luca; Liberali, Valentino; Crescioli, Francesco; Fedi, Giacomo; Sotiropoulou, Calliope-louisa; De Canio, Francesco; Traversi, Gianluca; Shojaii, Seyed Ruhollah; Kubota, Takashi; Calderini, Giovanni; Palla, Fabrizio; Checcucci, Bruno; Spiller, Laurence Anthony; Mcnamara, Peter Charles

    2018-01-01

    This documents defines the specifications for the Associative Memory ASIC for Phase-II. The work-flow toward the final ASIC is organized in the following three steps • AM08 prototype: small area MPW prototype to test all the full custom features, the VHDL logic and the I/O. This chip must be fully functional with smaller memory area than the final ASIC; • AM09pre pre-production: full area ASIC to be fabricated with a full-mask set pilot run. Production corner wafers will be created; • AM09 production: full area ASIC with refinements for the mass production. The AM09 will be developed built on the AM08 extending the memory area, therefore the specification of both versions must be compatible.

  17. Holifield Heavy Ion Research Facility. Phase II

    International Nuclear Information System (INIS)

    Ball, J.B.; Hudson, E.D.; Lord, R.S.; Johnson, J.W.; Martin, J.A.; McNeilly, G.S.; Milner, W.T.; Mosko, S.W.; Sayer, R.O.; Robinson, R.L.

    1979-01-01

    The Holifield Heavy Ion Research Facility, with the completion of Phase I in late 1979, will include the Oak Ridge Isochronous Cyclotron (ORIC) and associated research areas, the new 25 MV tandem accelerator with new research areas for tandem beams, and modifications to utilize the ORIC as a booster accelerator. The combination of the tandem and ORIC will provide beam energies of 25 MeV/A for light heavy ions and 6 MeV/A up to A = 160. This paper discusses plans for a Phase II expansion of the facility to include an isochronous cyclotron with superconducting magnet and reconfiguration of the existing research areas and the ORIC vault to handle the higher energy beams from the new cyclotron. The new booster cyclotron is a low-flutter high-spiral design patterned after the MSU K = 800 design, with a central magnetic field of about 5 tesla and an extraction radius of 1 meter. The new beam transport system will incorporate an rf beam-splitter system that will be able to deliver successive beam pulses to two or three experiment areas

  18. High Performance Wafer-Based Capillary Electrochromatography, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The Phase II research comprises designing, constructing, and testing a chip-based capillary electrochromatography (CEC) prototype for separation and analysis of...

  19. Ultraflat Tip-Tilt-Piston MEMS Deformable Mirror, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This proposal describes a Phase II SBIR project to develop high-resolution, ultraflat micromirror array devices using advanced silicon surface micromachining...

  20. Post Process Characterization of Friction Stir Welded Components, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Luna Innovations Incorporated proposes in this STTR Phase II project to continue development and validation of Luna's amplitude-dependent, nonlinear ultrasonic...

  1. Efficacy of a Community-Based Physical Activity Program KM2H2 for Stroke and Heart Attack Prevention among Senior Hypertensive Patients: A Cluster Randomized Controlled Phase-II Trial.

    Directory of Open Access Journals (Sweden)

    Jie Gong

    Full Text Available To evaluate the efficacy of the program Keep Moving toward Healthy Heart and Healthy Brain (KM2H2 in encouraging physical activities for the prevention of heart attack and stroke among hypertensive patients enrolled in the Community-Based Hypertension Control Program (CBHCP.Cluster randomized controlled trial with three waves of longitudinal assessments at baseline, 3 and 6 months post intervention.Community-based and patient-centered self-care for behavioral intervention in urban settings of China.A total of 450 participants diagnosed with hypertension from 12 community health centers in Wuhan, China were recruited, and were randomly assigned by center to receive either KM2H2 plus standard CBHCP care (6 centers and 232 patients or the standard care only (6 centers and 218 patients.KM2H2 is a behavioral intervention guided by the Transtheoretical Model, the Model of Personalized Medicine and Social Capital Theory. It consists of six intervention sessions and two booster sessions engineered in a progressive manner. The purpose is to motivate and maintain physical activities for the prevention of heart attack and stroke.Heart attack and stroke (clinically diagnosed, primary outcome, blood pressure (measured, secondary outcome, and physical activity (self-report, tertiary outcome were assessed at the individual level during the baseline, 3- and 6-month post-intervention.Relative to the standard care, receiving KM2H2 was associated with significant reductions in the incidence of heart attack (3.60% vs. 7.03%, p < .05 and stroke (5.11% vs. 9.90%, p<0.05, and moderate reduction in blood pressure (-3.72 mmHg in DBP and -2.92 mmHg in DBP at 6-month post-intervention; and significant increases in physical activity at 3- (d = 0.53, 95% CI: 0.21, 0.85 and 6-month (d = 0.45, 95% CI: 0.04, 0.85 post-intervention, respectively.The program KM2H2 is efficacious to reduce the risk of heart attack and stroke among senior patients who are on anti

  2. Tolerance and efficacy of conformal radiotherapy for hepatocellular carcinoma in cirrhotic patients. Results of the French RTF1 phase 2 trial; Tolerance et efficacite de la radiotherapie de conformation en cas de carcinome hepatocellulaire chez le patient cirrhotique. Resultats de l'essai de phase II RTF1

    Energy Technology Data Exchange (ETDEWEB)

    Mornex, F.; Girard, N.; Wautot, V.; Khodri, M. [Centre Hospitalier Lyon-Sud, Dept. de Radiotherapie-Oncologie, 69 - Pierre-Benite (France); Merle, P.; Kubas, A.; Trepo, C. [Hopital de l' Hotel-Dieu, Service d' hepatogastroenterologie, 69 - Lyon (France); Beziat, C. [Hopital de l' Hotel-Dieu, Dept. de Radiologie, 69 - Lyon (France)

    2005-11-15

    Purpose. - While some patients presenting with hepatocellular carcinoma (HCC) benefit from curative therapies (transplantation, surgery, percutaneous ablation), others are only candidates for palliative options such as chemo-embolization or symptomatic care. Although conventional external-beam radiotherapy of the liver is regarded as little efficient and potentially toxic in cirrhotic patients, 3-dimensional conformal radiotherapy (CRT), by decreasing the amount of normal liver included in the radiation portal, allows dose escalation to occur without increasing the risk of radiation-induced hepatitis. This trial was designed to assess the efficacy and tolerance of CRT for small-size HCC in cirrhotic patients. Patients and methods. - Prospective phase II trial including stage A/B cirrhotic patients with small-size HCC not suitable for curative treatments; CRT consisted in a standard fractionation radiation, with a total dose of 66 Gy. Results. - Twenty-seven patients were included, 15 of whom had previously been treated for HCC; mean age was 68. Among the 23 assessable patients, 18 (78%) presented with complete response, 3 (13%) with partial response, and 2 with no response. Acute complications occurred in 24 patients, and were mainly acceptable (grade 1/2: 22 patients, grade 3/4: 11 patients, 4 (15%) of whom had clinical and/or hematological toxicities). Only 2 (9%) grade 3/4 clinical and/or hematological late toxicities are reported. Conclusion. - CRT is a non-invasive curative technique highly suitable for small-size HCC in cirrhotic patients; further investigations are needed to compare it to the other available treatments, and to integrate it into the curative therapeutic algorithm of HCC. (author)

  3. Improved Metal-Polymeric Laminate Radiation Shielding, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In this proposed Phase II program, builds on the phase I feaibility where a multifunctional lightweight radiation shield composite was developed and fabricated. This...

  4. Reclaimable Thermally Reversible Polymers for AM Feedstock, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — CRG proposes to continue efforts from the 2016 NASA SBIR Phase I topic H5.04 Reclaimable Thermally Reversible Polymers for AM Feedstock. In Phase II, CRG will refine...

  5. Single Electron Transistor Platform for Microgravity Proteomics, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This Phase II program builds from the successful Phase I efforts to demonstrate that Quantum Logic Devices' nanoelectronic platform for biological detection could...

  6. Pressure Controlled Heat Pipe for Precise Temperature Control, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The principal Phase II objective is to refine and further develop the prototype PCHP into a useful thermal management tool. The Phase I program established the...

  7. Compact 2-Micron Transmitter for Remote Sensing Applications, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In this Phase II effort we propose to work with NASA to extend the Phase I achievements, which focused on design and development of very compact master and...

  8. Rationale and design of the allogeneiC human mesenchymal stem cells (hMSC) in patients with aging fRAilTy via intravenoUS delivery (CRATUS) study: A phase I/II, randomized, blinded and placebo controlled trial to evaluate the safety and potential efficacy of allogeneic human mesenchymal stem cell infusion in patients with aging frailty.

    Science.gov (United States)

    Golpanian, Samuel; DiFede, Darcy L; Pujol, Marietsy V; Lowery, Maureen H; Levis-Dusseau, Silvina; Goldstein, Bradley J; Schulman, Ivonne H; Longsomboon, Bangon; Wolf, Ariel; Khan, Aisha; Heldman, Alan W; Goldschmidt-Clermont, Pascal J; Hare, Joshua M

    2016-03-15

    Frailty is a syndrome associated with reduced physiological reserves that increases an individual's vulnerability for developing increased morbidity and/or mortality. While most clinical trials have focused on exercise, nutrition, pharmacologic agents, or a multifactorial approach for the prevention and attenuation of frailty, none have studied the use of cell-based therapies. We hypothesize that the application of allogeneic human mesenchymal stem cells (allo-hMSCs) as a therapeutic agent for individuals with frailty is safe and efficacious. The CRATUS trial comprises an initial non-blinded phase I study, followed by a blinded, randomized phase I/II study (with an optional follow-up phase) that will address the safety and pre-specified beneficial effects in patients with the aging frailty syndrome. In the initial phase I protocol, allo-hMSCs will be administered in escalating doses via peripheral intravenous infusion (n=15) to patients allocated to three treatment groups: Group 1 (n=5, 20 million allo-hMSCs), Group 2 (n=5, 100 million allo-hMSCs), and Group 3 (n=5, 200 million allo-hMSCs). Subsequently, in the randomized phase, allo-hMSCs or matched placebo will be administered to patients (n=30) randomly allocated in a 1:1:1 ratio to one of two doses of MSCs versus placebo: Group A (n=10, 100 million allo-hMSCs), Group B (n=10, 200 million allo-hMSCs), and Group C (n=10, placebo). Primary and secondary objectives are, respectively, to demonstrate the safety and efficacy of allo-hMSCs administered in frail older individuals. This study will determine the safety of intravenous infusion of stem cells and compare phenotypic outcomes in patients with aging frailty.

  9. The Phase II ATLAS ITk Pixel Upgrade

    CERN Document Server

    Terzo, Stefano; The ATLAS collaboration

    2017-01-01

    The entire tracking system of the ATLAS experiment will be replaced during the LHC Phase II shutdown (foreseen to take place around 2025) by an all-silicon detector called the "ITk" (Inner Tracker). The innermost portion of ITk will consist of a pixel detector with five layers in the barrel region and and ring-shaped supports in the endcap regions. It will be instrumented with new sensor and readout electronics technologies to improve the tracking performance and cope with the HL-LHC environment, which will be severe in terms of occupancy and radiation. The total surface area of silicon in the new pixel system could measure up to 14 m$^2$ , depending on the final layout choice, which is expected to take place in early 2017. Several layout options are being investigated at the moment, including some with novel inclined support structures in the barrel-endcap overlap region and others with very long innermost barrel layers. Forward coverage could be as high as $|\\eta| < 4$. Supporting structures will be ...

  10. 40 CFR 73.20 - Phase II early reduction credits.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Phase II early reduction credits. 73.20 Section 73.20 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) SULFUR DIOXIDE ALLOWANCE SYSTEM Allowance Allocations § 73.20 Phase II early reduction credits...

  11. Aging of snubbers in nuclear service: Phase I study results and Phase II plans

    International Nuclear Information System (INIS)

    Goodman, R.L.; Bush, S.H.; Page, R.E.

    1988-01-01

    Two major research areas were investigated in the Phase I snubber aging studies. The first area involved a preliminary evaluation of the effects of various aging mechanisms on snubber operation; failure modes of mechanisms were identified and their contributions to aging degradation were assessed relative to other failure modes. The second area involved estimating the efficacy of existing tests and examinations that are intended to determine the effects of aging and degradation. Available data on snubber behavior and operating experience were reviewed, using licensee event reports and other historical data for the 10-year period from 1973 through 1983. Value-impact was considered in terms of (1) exposure of workers to radioactive environments for examination/testing and (2) the cost for expansion of the snubber testing program due to failed snubbers. Results from the Phase I studies identified the need to modify or improve examination and testing procedures to enhance snubber reliability. Based on the results of the Phase I snubber studies, the seals and fluids were identified as the two principal elements affected by aging degradation in hydraulic snubbers. Phase II work, which was initiated in FY 1987, will develop cooperative activities between PNL and operating utilities through the Snubber Utility Group (SNUG), who will work to establish a strong data and experience base for both hydraulic and mechanical snubbers based on actual operating and maintenance history at nuclear power plants. Application guidelines for snubbers will be recommended based on the study results

  12. Kilowatt isotope power system. Phase II plan. Volume I. Phase II program plan

    International Nuclear Information System (INIS)

    1978-01-01

    The development of a Kilowatt Isotope Power System (KIPS) was begun in 1975 for the purpose of satisfying the power requirements of satellites in the 1980's. The KIPS is a 238 PuO 2 -fueled organic Rankine cycle turbine power system to provide a design output of 500 to 2000 W. Phase II of the overall 3-phase KIPS program is described. This volume presents a program plan for qualifying the organic Rankine power system for flight test in 1982. The program plan calls for the design and fabrication of the proposed flight power system; conducting a development and a qualification program including both environmental and endurance testing, using an electrical and a radioisotope heat source; planning for flight test and spacecraft integration; and continuing ground demonstration system testing to act as a flight system breadboard and to accumulate life data

  13. Efficacy and tolerability of chemotherapy with modified dose-dense TCF regimen (TCF-dd) in locally advanced or metastatic gastric cancer: final results of a phase II trial.

    Science.gov (United States)

    Tomasello, Gianluca; Liguigli, Wanda; Poli, Rossana; Lazzarelli, Silvia; Brighenti, Matteo; Negri, Federica; Curti, Alessandra; Martinotti, Mario; Olivetti, Lucio; Rovatti, Massimo; Donati, Gianvito; Passalacqua, Rodolfo

    2014-10-01

    We previously studied a dose-dense TCF (TCF-dd) regimen demonstrating its feasibility and an activity comparable to epirubicin-based chemotherapy and TCF q3w in terms of overall survival and time to progression (TTP). We report here the final results of a phase II study of chemotherapy with a modified TCF-dd regimen in locally advanced or metastatic gastric cancer (MGC). Patients with histologically confirmed measurable MGC, not previously treated for advanced disease, received docetaxel 70 mg/m(2) day 1, cisplatin 60 mg/m(2) day 1, l-folinic acid 100 mg/m(2) days 1 and 2, followed by 5-fluorouracil (5-FU) 400 mg/m(2) bolus days 1 and 2, and then 600 mg/m(2) as a 22-h continuous infusion days 1 and 2, every 14 days, plus pegfilgrastim 6 mg on day 3. Patients aged ≥65 years received the same schedule with a dose reduction of 30 %. Study duration: December 2007-November 2010. Forty-six consecutive patients were enrolled (78 % male, 22 % female; median age, 66 years, range, 38-76 years; ECOG PS: 0, 48 %, 1, 46 %). Primary endpoint was overall response rate (ORR). A median of four cycles (range, one to six) was administered. Forty-three patients were evaluated for response (93.5 %) and all for toxicity: 3 complete response (CR), 25 partial response (PR), 10 stable disease (SD), and 5 progressive disease (PD) were observed, for an ORR by intention to treat (ITT) of 61 % (95 % CI 47-75). Median overall survival (OS) was 17.63 months (95 % CI, 13.67-20.67); median progression-free survival was 8.9 months (95 % CI, 6.5-13.4). Twenty-one patients (46.0 %) were treated at full doses without any delay, thus respecting the dose-dense criterion. Most frequent grade 3-4 toxicities were neutropenia (20 %), leukopenia (4 %), thrombocytopenia (2 %), anemia (2 %), febrile neutropenia (6 %), asthenia (22 %), diarrhea (4 %), nausea/vomiting (11 %), and hypokalemia (6 %). Overall, TCF-dd was shown to be safe. The TCF-dd regimen in locally advanced or MGC

  14. Randomized double-blind placebo-controlled multicenter evaluation of efficacy and dose finding of midodrine hydrochloride in women with mild to moderate stress urinary incontinence: a phase II study.

    Science.gov (United States)

    Weil, E H; Eerdmans, P H; Dijkman, G A; Tamussino, K; Feyereisl, J; Vierhout, M E; Schmidbauer, C; Egarter, C; Kölle, D; Plasman, J E; Heidler, H; Abbühl, B E; Wein, W

    1998-01-01

    Midodrine is a potent and selective alpha1-receptor agonist and its potential to increase urethral closure pressure could be useful in the treatment of female stress incontinence. The aim of this randomized double-blind placebo-controlled multicenter study was to evaluate the efficacy and safety of midodrine for the treatment of stress urinary incontinence. The primary criterion of efficacy was the maximum urethral closure pressure at rest. Voiding diaries, symptom and incontinence questionnaires and patient/investigator global assessment were also used to evaluate its efficacy. After 4 weeks of treatment no significant changes in MUCP were found. The global assessment by the patient and investigator did indicate that patients on active treatment had a more positive assessment than the placebo group. In conclusion, midodrine did not cause significant improvements in urodynamic parameters, but there were subjective improvements in some of the patients in the treated groups. Furthermore midodrine was well tolerated.

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

    Science.gov (United States)

    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 - ...

  16. Nano-Phase Powder Based Exothermic Braze Repair Technology For RCC Materials, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The Phase II project will advance innovative, cost effective and reliable nano-phase exothermic RCC joining processes (ExoBrazeTM) in order to be able to reinforce...

  17. Thymostimulin in advanced hepatocellular carcinoma: A phase II trial

    Directory of Open Access Journals (Sweden)

    Behl Susanne

    2008-03-01

    Full Text Available Abstract Background Thymostimulin is a thymic peptide fraction with immune-mediated cytotoxicity against hepatocellular carcinoma in vitro. In a phase II trial, we investigated safety and efficacy including selection criteria for best response in advanced or metastasised hepatocellular carcinoma. Methods 44 patients (84 % male, median age 69 years not suitable or refractory to conventional therapy received thymostimulin 75 mg subcutaneously five times per week for a median of 8.2 months until progression or complete response. 3/44 patients were secondarily accessible to local ablation or chemoembolisation. Primary endpoint was overall survival, secondary endpoint tumor response or progression-free survival. A multivariate Cox's regression model was used to identify variables affecting survival. Results Median survival was 11.5 months (95% CI 7.9–15.0 with a 1-, 2- and 3-year survival of 50%, 23% and 9%. In the univariate analysis, a low Child-Pugh-score (p = 0.01, a low score in the Okuda- and CLIP-classification (p Conclusion Outcome in our study rather depended on liver function and intrahepatic tumor growth (presence of liver cirrhosis and Okuda stage in addition to response to thymostimulin, while an invasive HCC phenotype had no influence in the multivariate analysis. Thymostimulin could therefore be considered a safe and promising candidate for palliative treatment in a selected target population with advanced hepatocellular carcinoma, in particular as component of a multimodal therapy concept. Trial registration Current Controlled Trials ISRCTN29319366.

  18. Composite Structure Monitoring using Direct Write Sensors, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This NASA SBIR Phase II project seeks to develop and demonstrate a suite of sensor products to monitor the health of composite structures. Sensors will be made using...

  19. Instrument for Airborne Measurement of Carbonyl Sulfide, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In this Phase II SBIR program, Southwest Sciences will continue the development of small, low power instrumentation for real-time direct measurement of carbonyl...

  20. Advanced Technology Cloud Particle Probe for UAS, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In Phase II SPEC will design, fabricate and flight test a state-of-the-art combined cloud particle probe called the Hawkeye. Hawkeye is the culmination of two...

  1. Novel Instrumentation for Rocket Propulsion Systems, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The objective of the proposed SBIR Phase II program is to develop, deploy and deliver novel laser-based instruments that provide rapid, in situ, simultaneous...

  2. Space-Ready Advanced Imaging System, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In this Phase II effort Toyon will increase the state-of-the-art for video/image systems. This will include digital image compression algorithms as well as system...

  3. Lightweight Metal RubberTM Sensors and Interconnects, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The objective of this NASA Phase II program is to develop and increase the Technology Readiness Level of multifunctional Metal RubberTM (MRTM) materials that can be...

  4. Shape Memory Alloy-Based Periodic Cellular Structures, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This SBIR Phase II effort will continue to develop and demonstrate an innovative shape memory alloy (SMA) periodic cellular structural technology. Periodic cellular...

  5. InGaN High Temperature Photovoltaic Cells, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The objectives of this Phase II project are to develop InGaN photovoltaic cells for high temperature and/or high radiation environments to TRL 4 and to define the...

  6. High Radiation Resistance Inverted Metamorphic Solar Cell, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The innovation in this SBIR Phase II project is the development of a unique triple junction inverted metamorphic technology (IMM), which will enable the...

  7. Ground Processing Optimization Using Artificial Intelligence Techniques, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The ultimate goal is the automation of a large amount of KSC's planning, scheduling, and execution decision making. Phase II will result in a complete full-scale...

  8. Sears Point Tidal Marsh Restoration Project: Phase II

    Science.gov (United States)

    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.

  9. Diagnosis-Driven Prognosis for Decision Making, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In Phase II, the QSI-Vanderbilt team seeks to develop a system-level diagnostics and prognostic process that incorporates a "sense and respond capability," which...

  10. Compact, High Accuracy CO2 Monitor, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This Small Business Innovative Research Phase II proposal seeks to develop a low cost, robust, highly precise and accurate CO2 monitoring system. This system will...

  11. Multifunctional Aerogel Thermal Protection Systems for Hypersonic Vehicles, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The overall objective of the Phase II project is to develop lightweight reinforced aerogel materials for use as the core structural insulation material in...

  12. UltraSail Solar Sail Flight Experiment, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — A team of CU Aerospace, the University of Illinois, and ManTech SRS Technologies proposes Phase II development of a 3 kg CubeSat spacecraft for initial flight test...

  13. South Bay Salt Pond Tidal Wetland Restoration Phase II Planning

    Science.gov (United States)

    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

  14. South Bay Salt Pond Restoration, Phase II at Ravenswood

    Science.gov (United States)

    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.

  15. Recession-Tolerant Sensors for Thermal Protection Systems, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The Phase II project will develop a suite of diagnostic sensors using Direct Write technology to measure temperature, surface recession depth, and heat flux of an...

  16. Improved Lunar and Martian Regolith Simulant Production, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The technical objective of the Phase II project is to provide a more complete investigation of the long-term needs of the simulant community based on the updated...

  17. A Nanodroplet Processor for Advanced Microencapsulated Drug Formulations, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — During this Phase II program we propose to build on the key aspects of the nanodroplet encapsulation technology to demonstrate optimized formulation and...

  18. Multi-Channel Tunable Source for Atomic Sensors, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This Phase II SBIR will seek to develop a prototype laser source suitable for atomic interferometry from compact, robust, integrated components. AdvR's design is...

  19. Cash Impact of the Consumable Item Transfer, Phase II

    National Research Council Canada - National Science Library

    1998-01-01

    ...). This report is the third in a series of reports regarding the consumable item transfer (CIT), phase II. The Deputy Secretary of Defense directed the transfer of the management of consumable items to Defense Logistics Agency...

  20. Savanna ecosystem project: phase I summary and phase II progress

    CSIR Research Space (South Africa)

    Huntely, BJ

    1978-07-01

    Full Text Available A summary of the results of the first phase (mid 1974 to mid 1976) of the South African Savanna Ecosystem Project being undertaken at Nylsvley in the northern Transvaal is presented. Phase I of this ten year study of the structure and functioning...

  1. Barriers to participation in a phase II cardiac rehabilitation programme.

    Science.gov (United States)

    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.

  2. Miniature Active Space Radiation Dosimeter, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Space Micro will extend our Phase I R&D to develop a family of miniature, active space radiation dosimeters/particle counters, with a focus on biological/manned...

  3. Longwave Imaging for Astronomical Applications, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — We propose to develop a compact portable longwave camera for astronomical applications. In Phase 1, we successfully developed the eye of the camera, i.e. the focal...

  4. On-Demand Urine Analyzer, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The overall goal of this program (through Phase III) is to develop an analyzer that can be integrated into International Space Station (ISS) toilets to measure key...

  5. Optical Landing Hazard Sensor, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Visidyne's Phase I effort has established through modeling and analysis that a unique concept for an active optical 3-D Imager (or Imaging LADAR) has high potential...

  6. Integrated Multidisciplinary Optimization Objects, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — During Phase I, M4 Engineering integrated a prototype system into OpenMDAO, a NASA GRC open-source framework. This prototype system was a proof-of-concept that M4...

  7. Virtual Sensor Test Instrumentation, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Mobitrum has started the development of virtual sensor test instrumentation in Phase I for characterization and measurement of ground testing of propulsion systems....

  8. Software Defined Multiband EVA Radio, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The objective of Phase 2 is to build a reliable, lightweight, programmable, multi-mode, miniaturized EVA Software Defined Radio (SDR) that supports data telemetry,...

  9. Tactile Data Entry System, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Building on our successful Phase I Tactile Data Entry program, Barron Associates proposes development of a Glove-Enabled Computer Operations (GECO) system to permit...

  10. Upgrade for Phase II of the Gerda experiment

    Science.gov (United States)

    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.

  11. Caspian energy phase II: Beyond 2005

    International Nuclear Information System (INIS)

    Shaffer, Brenda

    2010-01-01

    This article examines the major factors that will shape the second phase of Caspian oil and natural gas export. The article compares the prospects of the post-2005 period with the Caspian energy developments in the first decade and a half after independence. This article claims: One, political considerations will continue to play an important role in the decisions on export routes for and participants in Caspian energy production and export projects. However, those political considerations will produce different policies in phase two of Caspian energy production than they did in the first phase. Second, the relative influence and interest in the Caspian region of various global and regional powers have changed significantly from Caspian energy phase one to phase two. Third, the producers in the region are not as anxious for foreign investment as they were earlier. The major resources that will be developed in Caspian phase two are: new production of Azerbaijan's natural gas, extension to new markets and expansion of capacity of existing gas export routes; new production projects for Turkmenistan's natural gas and new pipelines; and additional Kazakhstani oil production and natural gas increased production and initiation of export.

  12. The efficacy and safety of palonosetron compared with granisetron in preventing highly emetogenic chemotherapy-induced vomiting in the Chinese cancer patients: a phase II, multicenter, randomized, double-blind, parallel, comparative clinical trial.

    Science.gov (United States)

    Yu, Zhaocai; Liu, Wenchao; Wang, Ling; Liang, Houjie; Huang, Ying; Si, Xiaoming; Zhang, Helong; Liu, Duhu; Zhang, Hongmei

    2009-01-01

    This clinical trial was conducted to evaluate the efficacy and safety of Palonosetron in preventing chemotherapy-induced vomiting (CIV) among the Chinese cancer patients. Two hundred and forty patients were scheduled to be enrolled and randomized to receive a single intravenous dose of palonosetron 0.25 mg, or granisetron 3 mg, 30 min before receiving highly emetogenic chemotherapy. The primary efficacy endpoint was the complete response (CR) rate for acute CIV (during the 0-24-h interval after chemotherapy). Secondary endpoints included the CR rates for delayed CIV (more than 24 h after chemotherapy). Two hundred and eight patients were accrued and received study medication. CR rates for acute CIV were 82.69% for palonosetron and 72.12% for granisetron, which demonstrated that palonosetron was not inferior to granisetron in preventing acute CIV. Comparisons of CR rates for delayed CIV yielded no statistical difference between palonosetron and granisetron groups and did not reveal non-inferiority of palonosetron to granisetron. Adverse events were mostly mild to moderate, with quite low rates among the two groups. A single dose (0.25 mg) of palonosetron is not inferior to a single dose (3 mg) of granisetron in preventing CIV and possesses an acceptable safety profile in the Chinese population.

  13. Phase I (or phase II) dose-ranging clinical trials: proposal of a two-stage Bayesian design.

    Science.gov (United States)

    Zohar, Sarah; Chevret, Sylvie

    2003-02-01

    We propose a new design for phase I (or phase II) dose-ranging clinical trials aiming at determining a dose of an experimental treatment to satisfy safety (respectively efficacy) requirements, at treating a sufficiently large number of patients to estimate the toxicity (respectively failure) probability of the dose level with a given reliability, and at stopping the trial early if it is likely that no dose is safe (respectively efficacious). A two-stage design was derived from the Continual Reassessment Method (CRM), with implementation of Bayesian criteria to generate stopping rules. A simulation study was conducted to compare the operating characteristics of the proposed two-stage design to those reached by the traditional CRM. Finally, two applications to real data sets are provided.

  14. The efficacy and safety of S-flurbiprofen plaster in the treatment of knee osteoarthritis: a phase II, randomized, double-blind, placebo-controlled, dose-finding study

    Directory of Open Access Journals (Sweden)

    Yataba I

    2017-04-01

    Full Text Available Ikuko Yataba,1 Noboru Otsuka,1 Isao Matsushita,1 Hideo Matsumoto,2 Yuichi Hoshino3 1Taisho Pharmaceutical Co, Ltd, 2Institute for Integrated Sports Medicine, School of Medicine, Keio University, Tokyo, 3Department of Orthopedics Surgery, School of Medicine, Jichi Medical University, Tochigi, Japan Background: Nonsteroidal anti-inflammatory drug (NSAID patches are convenient for use and show much less gastrointestinal side effects than oral NSAIDs, whereas its percutaneous absorption is not sufficient for the expression of clinical efficacy at satisfactory level. S-flurbiprofen plaster (SFPP has shown dramatic improvement in percutaneous absorption results from animal and clinical studies. In this study, the efficacy and safety of SFPP were compared with placebo in patients with knee osteoarthritis (OA to determine its optimal dose. This was a multicenter, randomized, double-blind, parallel-group comparative study. Patients and methods: Enrolled 509 knee OA patients were treated with placebo or SFPP at 10, 20, or 40 mg applied on the affected site once daily for 2 weeks. The primary endpoint for efficacy was improvement in knee pain on rising from the chair assessed by visual analog scale (VAS. The other endpoints were clinical symptoms, pain on walking, and global assessment by both investigator and patient. Safety was evaluated by observing adverse events (AEs. Results: VAS change in knee pain from baseline to trial end was dose-dependent, least squares mean was 29.5, 31.5, 32.0, and 35.6 mm in placebo and SFPP 10, 20, and 40 mg, respectively. A significant difference was observed between placebo and SFPP 40 mg (P=0.001. In contrast, the effect of SFPP at a dose ≤20 mg was not significantly different from that of placebo. The proportion of the patients who achieved 50% pain relief was 72.4% in 40 mg and 51.2% in placebo (P<0.001. In all other endpoints, SFPP 40 mg showed significant improvement compared with placebo. The incidence of AEs was

  15. Brazilian Decimetric Array (BDA) project - Phase II

    Science.gov (United States)

    Faria, C.; Stephany, S.; Sawant, H. S.; Cecatto, J. R.; Fernandes, F. C. R.

    2010-02-01

    The configuration of the second phase of the Brazilian Decimetric Array (BDA), installed at Cachoeira Paulista, Brazil (Longitude 45° 0‧ 20″ W and Latitude 22° 41‧ 19″ S), is a T-shaped array where 21 antennas are being added to existing 5 antennas of the first phase. In the third phase, in each arm of the T array, four more antennas will be added and baselines will be increased to 2.5 × 1.25 km in east-west and south directions, respectively. The antennas will be equally spaced at the distances of 250 meters from the central antenna of the T-array. Also, the frequency range will be increased to 1.2-1.7, 2.8 and 5.6 GHz. The Second phase of the BDA should be operational by the middle of 2010 and will operate in the frequency range of (1.2-1.7) GHz for solar and non solar observations. Here, we present the characteristics of the second phase of the BDA project, details of the array configuration, the u-v coverage, the synthesized beam obtained for the proposed configuration.

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

    Science.gov (United States)

    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...

  17. Performance of the LAr scintillation veto of Gerda Phase II

    Energy Technology Data Exchange (ETDEWEB)

    Wiesinger, Christoph [Physik-Department and Excellence Cluster Universe, Technische Universitaet Muenchen, James-Franck-Strasse, 85748 Garching (Germany); Collaboration: GERDA-Collaboration

    2016-07-01

    Gerda is an experiment to search for the neutrinoless double beta decay in {sup 76}Ge. Results of Phase I have been published in summer 2013 and Gerda has been upgraded to Phase II. To reach the aspired background index of ∝10{sup -3} cts/(keV.kg.yr) for Phase II active background-suppression techniques are applied, including an active liquid argon (LAr) veto. It has been demonstrated with the LArGe test facility that the detection of argon scintillation light can be used to effectively suppress background events in the germanium detectors, which simultaneously deposit energy in the LAr. The light instrumentation consisting of photomultiplier tubes (PMT) and wavelength-shifting fibers connected to silicon photomultipliers (SiPM) has been installed in Gerda. In this talk the low background design of the LAr veto and its performance during Phase II start-up is reported.

  18. Methodology of phase II clinical trials in metastatic elderly breast cancer: a literature review.

    Science.gov (United States)

    Cabarrou, B; Mourey, L; Dalenc, F; Balardy, L; Kanoun, D; Roché, H; Boher, J M; Rougé-Bugat, M E; Filleron, Thomas

    2017-08-01

    As the incidence of invasive breast cancer will increase with age, the number of elderly patients with a diagnosis metastatic breast cancer will also rise. But the use of cytotoxic drugs in elderly metastatic breast cancer patients is not systematic and is dreaded by medical oncologists. The need for prospective oncologic data from this population seems increasingly obvious. The main objective of this review is to investigate design and characteristics of phase II trials that assess activity and feasibility of chemotherapies in elderly advanced/metastatic breast cancer patients. An electronic search in PUBMED allowed us to retrieve articles published in English language on phase II trials in elderly metastatic breast cancer between January 2002 and May 2016. Sixteen publications were finally included in this review. The primary endpoint was a simple, a composite, and a co-primary endpoints in 11, three, and two studies, respectively. Efficacy was the primary objective in 15 studies: simple (n = 10), composite (n = 3), co-primary endpoints (n = 2). Composite or co-primary endpoints combined efficacy and toxicity. Thirteen studies used multistage designs. Only five studies evaluated the feasibility, i.e., to jointly assess efficacy and tolerance to treatment (toxicity, quality of life, etc) as primary endpoint. Development of elderly specific phase III clinical trials might be challenging, it therefore seems essential to conduct phase II clinical trials evaluating jointly efficacy and toxicity in a well-defined geriatric population. Use of multistage designs that take into account heterogeneity would allow to identify a subpopulation at interim analysis and to reduce the number of patients exposed to an inefficient or a toxic treatment regimen. It is crucial to evaluate new therapies (targeted therapies, immunotherapies) using adequate methodologies (Study design, endpoint).

  19. Randomised Phase I/II trial assessing the safety and efficacy of radiolabelled anti-carcinoembryonic antigen I131 KAb201 antibodies given intra-arterially or intravenously in patients with unresectable pancreatic adenocarcinoma

    International Nuclear Information System (INIS)

    Sultana, Asma; Garvey, Conall; Sutton, Robert; Neoptolemos, John P; Ghaneh, Paula; Shore, Susannah; Raraty, Michael GT; Vinjamuri, Sobhan; Evans, Jonathan E; Smith, Catrin Tudur; Lane, Steven; Chauhan, Seema; Bosonnet, Lorraine

    2009-01-01

    Advanced pancreatic cancer has a poor prognosis, and the current standard of care (gemcitabine based chemotherapy) provides a small survival advantage. However the drawback is the accompanying systemic toxicity, which targeted treatments may overcome. This study aimed to evaluate the safety and tolerability of KAb201, an anti-carcinoembryonic antigen monoclonal antibody, labelled with I 131 in pancreatic cancer (ISRCTN 16857581). Patients with histological/cytological proven inoperable adenocarcinoma of the head of pancreas were randomised to receive KAb 201 via either the intra-arterial or intravenous delivery route. The dose limiting toxicities within each group were determined. Patients were assessed for safety and efficacy and followed up until death. Between February 2003 and July 2005, 25 patients were enrolled. Nineteen patients were randomised, 9 to the intravenous and 10 to the intra-arterial arms. In the intra-arterial arm, dose limiting toxicity was seen in 2/6 (33%) patients at 50 mCi whereas in the intravenous arm, dose limiting toxicity was noted in 1/6 patients at 50 mCi, but did not occur at 75 mCi (0/3). The overall response rate was 6% (1/18). Median overall survival was 5.2 months (95% confidence interval = 3.3 to 9 months), with no significant difference between the intravenous and intra-arterial arms (log rank test p = 0.79). One patient was still alive at the time of this analysis. Dose limiting toxicity for KAb201 with I 131 by the intra-arterial route was 50 mCi, while dose limiting toxicity was not reached in the intravenous arm

  20. A randomized, double-blind, placebo-controlled, phase II clinical trial to investigate the efficacy and safety of oral DA-1229 in patients with type 2 diabetes mellitus who have inadequate glycaemic control with diet and exercise.

    Science.gov (United States)

    Jung, Chang Hee; Park, Cheol-Young; Ahn, Kyu-Joeng; Kim, Nan-Hee; Jang, Hak-Chul; Lee, Moon-Kyu; Park, Joong-Yeol; Chung, Choon-Hee; Min, Kyung-Wan; Sung, Yeon-Ah; Park, Jeong-Hyun; Kim, Sung Jin; Lee, Hyo Jung; Park, Sung-Woo

    2015-03-01

    DA-1229 is a novel, potent and selective dipeptidyl peptidase-4 (DPP-IV) inhibitor that is orally bioavailable. We aimed to evaluate the optimal dose, efficacy and safety of DA-1229, in Korean subjects with type 2 diabetes mellitus suboptimally controlled with diet and exercise. We enrolled 158 patients (mean age, 53 years and a mean BMI, 25.6 kg/m(2) ). The mean baseline fasting plasma glucose level, HbA1c and duration of diabetes were 8.28 mmol/L, 7.6% (60 mmol/mol) and 3.9 years, respectively. After 2 or 6 weeks of an exercise and diet program followed by 2 weeks of a placebo period, the subjects were randomized into one of four groups for a 12-week active treatment period: placebo, 2.5, 5 or 10 mg of DA-1229. All three doses of DA-1229 significantly reduced HbA1c from baseline compared to the placebo group (-0.09 in the placebo group vs. -0.56, -0.66 and -0.61% in 2.5, 5 and 10-mg groups, respectively) but without any significant differences between the doses. Insulin secretory function, as assessed by homeostasis model assessment β-cell, the insulinogenic index, 2-h oral glucose tolerance test (OGTT) C-peptide and post-OGTT C-peptide area under the curve (AUC)0-2h, significantly improved with DA-1229 treatment. The incidence of adverse events was similar between the treatment groups and DA-1229 did not affect body weight or induce hypoglycaemic events. DA-1229 monotherapy (5 mg for 12 weeks) improved HbA1c, fasting plasma glucose level, OGTT results and β-cell function. This drug was well tolerated in Korean subjects with type 2 diabetes mellitus. © 2014 The Authors. Diabetes/Metabolism Research and Reviews published by John Wiley & Sons, Ltd.

  1. Configuration management: Phase II implementation guidance

    Energy Technology Data Exchange (ETDEWEB)

    1994-03-01

    Configuration management (CM) is essential to maintaining an acceptable level of risk to the public, workers, environment, or mission success. It is a set of activities and techniques used to maintain consistency among physical and functional configuration, applicable requirements, and key documents. This document provides guidance for continuing the implementation of CM in a phased and graded manner. It describes a cost-effective approach to documented consistency with requirements, with early emphasis on items most important to safety and environmental protection. It is intended to help responsible line managers and configuration management staff personnel in meeting the Energy Systems configuration management policy standard.

  2. SIMMER-II analysis of transition-phase experiments

    International Nuclear Information System (INIS)

    Wehner, T.R.; Bell, C.R.

    1985-01-01

    Analyses of Los Alamos transition-phase experiments with the SIMMER-II computer code are reported. These transient boilup experiments simulated the recriticality-induced transient motion of a boiling pool of molten fuel, molten steel and steel vapor, within a subassembly duct in a liquid-metal fast breeder reactor during the transition phase of a core-disruptive accident. The two purposes of these experiments were to explore and reach a better understanding of fast reactor safety issues, and to provide data for SIMMER-II verification. Experimental data, consisting of four pressure traces and a high-speed movie, were recorded for four sets of initial conditions. For three of the four cases, SIMMER-II-calculated pressures compared reasonably well with the experimental pressures. After a modification to SIMMER-II's liquid-vapor drag correlation, the comparison for the fourth case was reasonable also. 12 refs., 4 figs

  3. A phase II trial with bevacizumab and irinotecan for patients with primary brain tumors and progression after standard therapy

    DEFF Research Database (Denmark)

    Møller, Søren; Grunnet, Kirsten; Hansen, Steinbjørn

    2012-01-01

    The combination of irinotecan and bevacizumab has shown efficacy in the treatment of recurrent glioblastoma multiforme (GBM). A prospective, phase II study of 85 patients with various recurrent brain tumors was carried out. Primary endpoints were progression free survival (PFS) and response rate....

  4. Oral fingolimod (FTY720) in multiple sclerosis: two-year results of a phase II extension study

    DEFF Research Database (Denmark)

    O'Connor, P; Comi, G; Montalban, X

    2009-01-01

    OBJECTIVE: To report the results of a 24-month extension of a phase II trial assessing the efficacy, safety, and tolerability of the once-daily oral sphingosine-1-phosphate receptor modulator, fingolimod (FTY720), in relapsing multiple sclerosis (MS). METHODS: In the randomized, double-blind, pla...

  5. Phase II beam lines at the National Synchrotron Light Source

    International Nuclear Information System (INIS)

    Thomlinson, W.

    1984-06-01

    The expansion of the National Synchrotron Light Source has been funded by the US Department of Energy. The Phase II program consists of both increased conventional facilities and six new beam lines. In this paper, an overview of the six beam lines which will be constructed during Phase II is presented. For five of the lines special radiation sources are necessary and the designs of four of the devices are complete. The relevant parameters of the insertion devices under construction and development are presented

  6. A Tool for Predicting Regulatory Approval After Phase II Testing of New Oncology Compounds.

    Science.gov (United States)

    DiMasi, J A; Hermann, J C; Twyman, K; Kondru, R K; Stergiopoulos, S; Getz, K A; Rackoff, W

    2015-11-01

    We developed an algorithm (ANDI) for predicting regulatory marketing approval for new cancer drugs after phase II testing has been conducted, with the objective of providing a tool to improve drug portfolio decision-making. We examined 98 oncology drugs from the top 50 pharmaceutical companies (2006 sales) that first entered clinical development from 1999 to 2007, had been taken to at least phase II development, and had a known final outcome (research abandonment or regulatory marketing approval). Data on safety, efficacy, operational, market, and company characteristics were obtained from public sources. Logistic regression and machine-learning methods were used to provide an unbiased approach to assess overall predictability and to identify the most important individual predictors. We found that a simple four-factor model (activity, number of patients in the pivotal phase II trial, phase II duration, and a prevalence-related measure) had high sensitivity and specificity for predicting regulatory marketing approval. © 2015 American Society for Clinical Pharmacology and Therapeutics.

  7. Performance of BEGe detectors for GERDA Phase II

    Energy Technology Data Exchange (ETDEWEB)

    Lazzaro, Andrea [Physik-Department E15, Technische Universitaet Muenchen (Germany); Collaboration: GERDA-Collaboration

    2015-07-01

    After the end of the data-taking for GERDA Phase I, the apparatus has been upgraded to fulfill the requirements of the second phase. Phase II sensitivity will be driven by 30 custom made BEGe detectors. This detectors are now available and can be operated in phaseII configuration in the GERDA cryostat together with the liquid argon scintillation veto. The performances of BEGe detectors in liquid argon are presented in this talk. Besides the spectroscopy capability, the focus will be placed on the expectations in terms of background rejection via pulse shape discrimination (PSD). In particular the main goal the BEGe's pulse shape analysis is to discriminate surface events produced by beta emitters (e.g. {sup 42}K) present in the liquid Ar.

  8. The SafeBoosC Phase II Randomised Clinical Trial

    DEFF Research Database (Denmark)

    Pellicer, Adelina; Greisen, Gorm; Benders, Manon

    2013-01-01

    Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin (rStO2) reflects venous oxygen saturation. If cerebral metabolism is stable, rStO2 can be used as an estimate of cerebral oxygen delivery. The SafeBoosC phase II randomised clinical trial hypothesises that the bur...

  9. The SafeBoosC phase II clinical trial

    DEFF Research Database (Denmark)

    Riera, Joan; Hyttel-Sorensen, Simon; Bravo, María Carmen

    2016-01-01

    BACKGROUND: The SafeBoosC phase II randomised clinical trial recently demonstrated the benefits of a combination of cerebral regional tissue oxygen saturation (rStO2) by near-infrared spectroscopy (NIRS) and a treatment guideline to reduce the oxygen imbalance in extremely preterm infants. AIMS: ...

  10. Caelyx (TM) in malignant mesothelioma : A phase II EORTC study

    NARCIS (Netherlands)

    Baas, P; van Meerbeeck, J; Groen, H; Schouwink, H; Burgers, S; Daamen, S; Giaccone, G

    Background: The use of doxorubicin has shown some activity in malignant mesothelioma but prolonged administration is hampered by cardiotoxicity. Caelyx(TM), a new liposomal and pegylated form of doxorubicin has shown a better pharmacokinetic and toxic profile then doxorubicin. In a phase II study,

  11. Anti-irritants II: Efficacy against cumulative irritation

    DEFF Research Database (Denmark)

    Andersen, Flemming; Hedegaard, Kathryn; Petersen, Thomas Kongstad

    2006-01-01

    window of opportunity in which to demonstrate efficacy. Therefore, the effect of AI was studied in a cumulative irritation model by inducing irritant dermatitis with 10 min daily exposures for 5+4 days (no irritation on weekend) to 1% sodium lauryl sulfate on the right and 20% nonanoic acid on the left...

  12. Mechanical Engineering and Design of the LHC Phase II Collimators

    CERN Document Server

    Bertarelli, A; Gentini, L; Mariani, N; Perret, R; Timmins, M A

    2010-01-01

    Phase II collimators will complement the existing system to improve the expected high RF impedance and limited efficiency of Phase I jaws. An international collaborative effort has been launched to identify novel advanced materials responding to the very challenging requirements of the new collimators. Complex numerical calculations simulating extreme conditions and experimental tests are in progress. In parallel, an innovative modular design concept of the jaw assembly is being developed to allow fitting in alternative materials, minimizing the thermally induced deformations, withstanding accidents and accepting high radiation doses. Phase II jaw assembly is made up of a molybdenum back-stiffener ensuring high geometrical stability and a modular jaw split in threes sectors. Each sector is equipped with a high-efficiency independent cooling circuit. Beam position monitors (BPM) are embedded in the jaws to fasten setup time and improve beam monitoring. An adjustment system will permit to fine-tune the jaw flat...

  13. Performance of the LAr scintillation veto of GERDA Phase II

    Energy Technology Data Exchange (ETDEWEB)

    Wiesinger, Christoph [Technische Universitaet Muenchen, Physik Dept. E15, James-Franck-Strasse, 85748 Garching (Germany); Collaboration: GERDA-Collaboration

    2015-07-01

    Gerda is an experiment to search for the neutrinoless double beta decay in {sup 76}Ge. Results of Phase I have been published in summer 2013 and Gerda is upgraded to Phase II. To reach the aspired background index of ≤ 10{sup -3} cts/(keV.kg.yr) for Phase II active background-suppression techniques are applied, including an active liquid argon (LAr) veto. It has been demonstrated with the LArGe test facility that the detection of argon scintillation light can be used to effectively suppress background events in the germanium, which simultaneously deposit energy in the LAr. The light instrumentation consisting of photomultiplier tubes (PMT) and wavelength-shifting fibers connected to silicon multipliers (SiPM) has been installed in Gerda. In this talk the low background design of the LAr veto and its performance during the commissioning runs are reported.

  14. Phase II Trials for Heterogeneous Patient Populations with a Time-to-Event Endpoint.

    Science.gov (United States)

    Jung, Sin-Ho

    2017-07-01

    In this paper, we consider a single-arm phase II trial with a time-to-event end-point. We assume that the study population has multiple subpopulations with different prognosis, but the study treatment is expected to be similarly efficacious across the subpopulations. We review a stratified one-sample log-rank test and present its sample size calculation method under some practical design settings. Our sample size method requires specification of the prevalence of subpopulations. We observe that the power of the resulting sample size is not very sensitive to misspecification of the prevalence.

  15. Steam generator tube integrity program: Phase II, Final report

    Energy Technology Data Exchange (ETDEWEB)

    Kurtz, R.J.; Bickford, R.L.; Clark, R.A.; Morris, C.J.; Simonen, F.A.; Wheeler, K.R.

    1988-08-01

    The Steam Generator Tube Integrity Program (SGTIP) was a three phase program conducted for the US Nuclear Regulatory Commission (NRC) by Pacific Northwest Laboratory (PNL). The first phase involved burst and collapse testing of typical steam generator tubing with machined defects. The second phase of the SGTIP continued the integrity testing work of Phase I, but tube specimens were degraded by chemical means rather than machining methods. The third phase of the program used a removed-from-service steam generator as a test bed for investigating the reliability and effectiveness of in-service nondestructive eddy-current inspection methods and as a source of service degraded tubes for validating the Phase I and Phase II data on tube integrity. This report describes the results of Phase II of the SGTIP. The object of this effort included burst and collapse testing of chemically defected pressurized water reactor (PWR) steam generator tubing to validate empirical equations of remaining tube integrity developed during Phase I. Three types of defect geometries were investigated: stress corrosion cracking (SCC), uniform thinning and elliptical wastage. In addition, a review of the publicly available leak rate data for steam generator tubes with axial and circumferential SCC and a comparison with an analytical leak rate model is presented. Lastly, nondestructive eddy-current (EC) measurements to determine accuracy of defect depth sizing using conventional and alternate standards is described. To supplement the laboratory EC data and obtain an estimate of EC capability to detect and size SCC, a mini-round robin test utilizing several firms that routinely perform in-service inspections was conducted.

  16. Steam generator tube integrity program: Phase II, Final report

    International Nuclear Information System (INIS)

    Kurtz, R.J.; Bickford, R.L.; Clark, R.A.; Morris, C.J.; Simonen, F.A.; Wheeler, K.R.

    1988-08-01

    The Steam Generator Tube Integrity Program (SGTIP) was a three phase program conducted for the US Nuclear Regulatory Commission (NRC) by Pacific Northwest Laboratory (PNL). The first phase involved burst and collapse testing of typical steam generator tubing with machined defects. The second phase of the SGTIP continued the integrity testing work of Phase I, but tube specimens were degraded by chemical means rather than machining methods. The third phase of the program used a removed-from-service steam generator as a test bed for investigating the reliability and effectiveness of in-service nondestructive eddy-current inspection methods and as a source of service degraded tubes for validating the Phase I and Phase II data on tube integrity. This report describes the results of Phase II of the SGTIP. The object of this effort included burst and collapse testing of chemically defected pressurized water reactor (PWR) steam generator tubing to validate empirical equations of remaining tube integrity developed during Phase I. Three types of defect geometries were investigated: stress corrosion cracking (SCC), uniform thinning and elliptical wastage. In addition, a review of the publicly available leak rate data for steam generator tubes with axial and circumferential SCC and a comparison with an analytical leak rate model is presented. Lastly, nondestructive eddy-current (EC) measurements to determine accuracy of defect depth sizing using conventional and alternate standards is described. To supplement the laboratory EC data and obtain an estimate of EC capability to detect and size SCC, a mini-round robin test utilizing several firms that routinely perform in-service inspections was conducted

  17. Optimal dose selection accounting for patient subpopulations in a randomized Phase II trial to maximize the success probability of a subsequent Phase III trial.

    Science.gov (United States)

    Takahashi, Fumihiro; Morita, Satoshi

    2018-02-08

    Phase II clinical trials are conducted to determine the optimal dose of the study drug for use in Phase III clinical trials while also balancing efficacy and safety. In conducting these trials, it may be important to consider subpopulations of patients grouped by background factors such as drug metabolism and kidney and liver function. Determining the optimal dose, as well as maximizing the effectiveness of the study drug by analyzing patient subpopulations, requires a complex decision-making process. In extreme cases, drug development has to be terminated due to inadequate efficacy or severe toxicity. Such a decision may be based on a particular subpopulation. We propose a Bayesian utility approach (BUART) to randomized Phase II clinical trials which uses a first-order bivariate normal dynamic linear model for efficacy and safety in order to determine the optimal dose and study population in a subsequent Phase III clinical trial. We carried out a simulation study under a wide range of clinical scenarios to evaluate the performance of the proposed method in comparison with a conventional method separately analyzing efficacy and safety in each patient population. The proposed method showed more favorable operating characteristics in determining the optimal population and dose.

  18. Development of ceramics based fuel, Phase II; Razvoj goriva na bazi keramike, II faza

    Energy Technology Data Exchange (ETDEWEB)

    Ristic, M M [Institute of Nuclear Sciences Vinca, Laboratorija za reaktorske materijale, Beograd (Serbia and Montenegro)

    1962-12-15

    Phase II of this task covers the following: testing the changes of UO{sub 2} properties during sintering; interpretation of results obtained from the analysis of the sintering process kinetics; fabrication of UO{sub 2} samples with cladding by vibrational compacting.

  19. Status report of the Gerda Phase II startup

    International Nuclear Information System (INIS)

    D’Andrea, Valerio

    2017-01-01

    The GERmanium Detector Array (Gerda) experiment, located at the Laboratori Nazionali del Gran Sasso (LNGS) of INFN, searches for 0νββ of "7"6Ge. Germanium diodes enriched to ∼ 86 % in the double beta emitter "7"6Ge ("e"n"rGe) are exposed being both source and detector of 0νββ decay. This process is considered a powerful probe to address still open issues in the neutrino sector of the (beyond) Standard Model of particle Physics. Since 2013, at the completion of the first experimental phase (Phase I), the Gerda setup has been upgraded to perform its next step (Phase II). The aim is to reach a sensitivity to the 0νββ decay half life larger than 10"2"6 yr in about 3 years of physics data taking, exposing a detector mass of about 35 kg of "e"n"rGe with a background index of about 10"−"3cts/(keV·kg·yr). One of the main new implementations is the liquid argon (LAr) scintillation light read-out, to veto those events that only partially deposit their energy both in Ge and in the surrounding LAr. In this paper the Gerda Phase II expected goals, the upgraded items and few selected features from the first 2016 physics and calibration runs will be presented. The main Phase I achievements will be also reviewed.

  20. Status report of the Gerda Phase II startup

    Science.gov (United States)

    D'Andrea, Valerio; Gerda Collaboration

    2017-01-01

    The GERmanium Detector Array (GERDA) experiment, located at the Laboratori Nazionali del Gran Sasso (LNGS) of INFN, searches for 0νββ of 76Ge . Germanium diodes enriched to ˜ 86 % in the double beta emitter 76Ge ( enrGe are exposed being both source and detector of 0νββ decay. This process is considered a powerful probe to address still open issues in the neutrino sector of the (beyond) Standard Model of particle Physics. Since 2013, at the completion of the first experimental phase (Phase I), the GERDA setup has been upgraded to perform its next step (Phase II). The aim is to reach a sensitivity to the 0νββ decay half-life larger than 10^{26} yr in about 3 years of physics data taking, exposing a detector mass of about 35 kg of enrGe with a background index of about 10^{-3} cts/(keV . kg . yr). One of the main new implementations is the liquid argon (LAr) scintillation light read-out, to veto those events that only partially deposit their energy both in Ge and in the surrounding LAr. In this paper the GERDA Phase II expected goals, the upgraded items and few selected features from the first 2016 physics and calibration runs will be presented. The main Phase I achievements will be also reviewed.

  1. Phase II cancer clinical trials for biomarker-guided treatments.

    Science.gov (United States)

    Jung, Sin-Ho

    2018-01-01

    The design and analysis of cancer clinical trials with biomarker depend on various factors, such as the phase of trials, the type of biomarker, whether the used biomarker is validated or not, and the study objectives. In this article, we demonstrate the design and analysis of two Phase II cancer clinical trials, one with a predictive biomarker and the other with an imaging prognostic biomarker. Statistical testing methods and their sample size calculation methods are presented for each trial. We assume that the primary endpoint of these trials is a time to event variable, but this concept can be used for any type of endpoint.

  2. Microbial Dark Matter Phase II: Stepping deeper into unknown territory

    Energy Technology Data Exchange (ETDEWEB)

    Jarett, Jessica; Dunfield, Peter; Peura, Sari; Wielen, Paul van der; Hedlund, Brian; Elshahed, Mostafa; Kormas, Konstantinos; Stott, Andreas Teske8, Matt; Birkeland, Nils-Kare; Zhang, Chuanlun; Rengefors, Karin; Lindemann, Stephen; Ravin, Nikolai V.; Spear, John; Hallam, Steven; Crowe, Sean; Steele, Jillian; Goudeau, Danielle; Malmstrom, Rex; Kyrpides, Nikos; Stepanauskas, Ramunas; Woyke, Tanja

    2014-10-27

    Currently available microbial genomes are of limited phylogenetic breadth due to our historical inability to cultivate most microorganisms in the laboratory. The first phase of the Microbial Dark Matter project used single-cell genomics to sequence 201 single cells from uncultivated lineages, and was able to resolve new superphyla and reveal novel metabolic features in bacteria and archaea. However, many fundamental questions about the evolution and function of microbes remain unanswered, and many candidate phyla remain uncharacterized. Phase II of the Microbial Dark Matter project will target candidate phyla with no sequenced representatives at a variety of new sites using a combination of single-cell sequencing and shotgun metagenomics approaches.

  3. PWR steam generator chemical cleaning. Phase II. Final report

    International Nuclear Information System (INIS)

    1980-01-01

    Two techniques believed capable of chemically dissolving the corrosion products in the annuli between tubes and support plates were developed in laboratory work in Phase I of this project and were pilot tested in Indian Point Unit No. 1 steam generators. In Phase II, one of the techniques was shown to be inadequate on an actual sample taken from an Indian Point Unit No. 2 steam generator. The other technique was modified slightly, and it was demonstrated that the tube/support plate annulus could be chemically cleaned effectively

  4. OSAS Surgery and Postoperative Discomfort: Phase I Surgery versus Phase II Surgery

    Directory of Open Access Journals (Sweden)

    Giulio Gasparini

    2015-01-01

    Full Text Available Introduction. This study aims to investigate the reasons that discourage the patients affected by OSAS to undergo orthognathic surgery and compares the postoperative discomfort of phase I (soft tissue surgery and phase II (orthognathic surgery procedures for treatment of OSAS. Material and Methods. A pool of 46 patients affected by OSAS was divided into two groups: “surgery patients” who accepted surgical treatments of their condition and “no surgery patients” who refused surgical procedures. The “surgery patients” group was further subdivided into two arms: patients who accepted phase I procedures (IP and those who accepted phase II (IIP. To better understand the motivations behind the refusal of II phase procedures, we asked the patients belonging to both the IP group and “no surgery” group to indicate the main reason that influenced their decision to avoid II phase procedures. We also monitored and compared five parameters of postoperative discomfort: pain, painkiller assumption, length of hospitalization, foreign body sensation, and diet assumption following IP and IIP procedures. Results. The main reason to avoid IIP procedures was the concern of a more severe postoperative discomfort. Comparison of the postoperative discomfort following IP versus IIP procedures showed that the former scored worse in 4 out of 5 parameters analyzed. Conclusion. IIP procedures produce less postoperative discomfort. IIP procedures, namely, orthognathic surgery, should be the first choice intervention in patients affected by OSAS and dentoskeletal malformation.

  5. Study of the GERDA Phase II background spectrum

    Science.gov (United States)

    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.; 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.; 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.

    2017-09-01

    The Gerda experiment, located at the Laboratori Nazionali del Gran Sasso (LNGS) of INFN in Italy, searches for the neutrinoless double beta (0νββ) decay of 76Ge. Gerda Phase II is aiming to reach a sensitivity for the 0νββ half life of 1026 yr in ˜ 3 years of physics data taking with 100 kg·yr of exposure and a background index of ˜ 10-3 cts/(keV·kg·yr). After 6 months of acquisition a first data release with 10.8 kg·yr of exposure is performed, showing that the design background is achieved. In this work a study of the Phase II background spectrum, the main spectral structures and the background sources will be presented and discussed.

  6. Urban Integrated Industrial Cogeneration Systems Analysis. Phase II final report

    Energy Technology Data Exchange (ETDEWEB)

    1984-01-01

    Through the Urban Integrated Industrial Cogeneration Systems Analysis (UIICSA), the City of Chicago embarked upon an ambitious effort to identify the measure the overall industrial cogeneration market in the city and to evaluate in detail the most promising market opportunities. This report discusses the background of the work completed during Phase II of the UIICSA and presents the results of economic feasibility studies conducted for three potential cogeneration sites in Chicago. Phase II focused on the feasibility of cogeneration at the three most promising sites: the Stockyards and Calumet industrial areas, and the Ford City commercial/industrial complex. Each feasibility case study considered the energy load requirements of the existing facilities at the site and the potential for attracting and serving new growth in the area. Alternative fuels and technologies, and ownership and financing options were also incorporated into the case studies. Finally, site specific considerations such as development incentives, zoning and building code restrictions and environmental requirements were investigated.

  7. Small Business Innovation Research, Post-Phase II Opportunity Assessment

    Science.gov (United States)

    Nguyen, Hung D.; Steele, Gynelle C.

    2015-01-01

    This report outlines current Small Business Innovation Research (SBIR) Post-Phase II opportunity contract award results for the SBIR technology program from 2007 to 2011 for NASA's Aeronautics Research Mission Directorate (ARMD), Human Exploration and Operations Mission Directorate (HEOMD), Science Mission Directorate (SMD), and Space Technology Mission Directorate (STMD). The report provides guidelines for incorporating SBIR technology into NASA programs and projects and provides a quantitative overview of the post-Phase II award patterns that correspond with each mission directorate at NASA Glenn Research Center (GRC). In recent years, one of NASA's goals has been to not only transfer SBIR technologies to commercial industries, but to ensure that NASA mission directorates incorporate SBIR technologies into their program and project activities. Before incorporating technologies into MD programs, it is important to understand each mission directorate structure because each directorate has different objectives and needs. The directorate program structures follow.

  8. Phase I/Phase II Study of Blinatumomab in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia.

    Science.gov (United States)

    von Stackelberg, Arend; Locatelli, Franco; Zugmaier, Gerhard; Handgretinger, Rupert; Trippett, Tanya M; Rizzari, Carmelo; Bader, Peter; O'Brien, Maureen M; Brethon, Benoît; Bhojwani, Deepa; Schlegel, Paul Gerhardt; Borkhardt, Arndt; Rheingold, Susan R; Cooper, Todd Michael; Zwaan, Christian M; Barnette, Phillip; Messina, Chiara; Michel, Gérard; DuBois, Steven G; Hu, Kuolung; Zhu, Min; Whitlock, James A; Gore, Lia

    2016-12-20

    Purpose Blinatumomab is a bispecific T-cell engager antibody construct targeting CD19 on B-cell lymphoblasts. We evaluated the safety, pharmacokinetics, recommended dosage, and potential for efficacy of blinatumomab in children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL). Methods This open-label study enrolled children treatment cycles. Primary end points were maximum-tolerated dosage (phase I) and complete remission rate within the first two cycles (phase II). Results We treated 49 patients in phase I and 44 patients in phase II. Four patients had dose-limiting toxicities in cycle 1 (phase I). Three experienced grade 4 cytokine-release syndrome (one attributed to grade 5 cardiac failure); one had fatal respiratory failure. The maximum-tolerated dosage was 15 µg/m 2 /d. Blinatumomab pharmacokinetics was linear across dosage levels and consistent among age groups. On the basis of the phase I data, the recommended blinatumomab dosage for children with relapsed/refractory ALL was 5 µg/m 2 /d for the first 7 days, followed by 15 µg/m 2 /d thereafter. Among the 70 patients who received the recommended dosage, 27 (39%; 95% CI, 27% to 51%) achieved complete remission within the first two cycles, 14 (52%) of whom achieved complete minimal residual disease response. The most frequent grade ≥ 3 adverse events were anemia (36%), thrombocytopenia (21%), and hypokalemia (17%). Three patients (4%) and one patient (1%) had cytokine-release syndrome of grade 3 and 4, respectively. Two patients (3%) interrupted treatment after grade 2 seizures. Conclusion This trial, which to the best of our knowledge was the first such trial in pediatrics, demonstrated antileukemic activity of single-agent blinatumomab with complete minimal residual disease response in children with relapsed/refractory BCP-ALL. Blinatumomab may represent an important new treatment option in this setting, requiring further investigation in curative indications.

  9. The STAR beam energy scan phase II physics and upgrades

    Czech Academy of Sciences Publication Activity Database

    Yang, C.; Adamczyk, L.; Adkins, J. K.; Agakishiev, G.; Bielčík, J.; Bielčíková, Jana; Chaloupka, P.; Federič, Pavol; Rusňák, Jan; Rusňáková, O.; Šimko, Miroslav; Šumbera, Michal; Vértési, Robert

    2017-01-01

    Roč. 967, č. 11 (2017), s. 800-803 ISSN 0375-9474 R&D Projects: GA MŠk LG15001; GA MŠk LM2015054 Institutional support: RVO:61389005 Keywords : STAR collaboration * BES-II * detector upgrade * QCD phase diagram * physics oppotrunity Subject RIV: BG - Nuclear, Atomic and Molecular Physics, Colliders OBOR OECD: Nuclear physics Impact factor: 1.916, year: 2016

  10. Malignant pleural mesothelioma: a phase II trial with docetaxel.

    Science.gov (United States)

    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.

  11. Reassessing Phase II Heart Failure Clinical Trials: Consensus Recommendations

    Science.gov (United States)

    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

  12. Probability of success for phase III after exploratory biomarker analysis in phase II.

    Science.gov (United States)

    Götte, Heiko; Kirchner, Marietta; Sailer, Martin Oliver

    2017-05-01

    The probability of success or average power describes the potential of a future trial by weighting the power with a probability distribution of the treatment effect. The treatment effect estimate from a previous trial can be used to define such a distribution. During the development of targeted therapies, it is common practice to look for predictive biomarkers. The consequence is that the trial population for phase III is often selected on the basis of the most extreme result from phase II biomarker subgroup analyses. In such a case, there is a tendency to overestimate the treatment effect. We investigate whether the overestimation of the treatment effect estimate from phase II is transformed into a positive bias for the probability of success for phase III. We simulate a phase II/III development program for targeted therapies. This simulation allows to investigate selection probabilities and allows to compare the estimated with the true probability of success. We consider the estimated probability of success with and without subgroup selection. Depending on the true treatment effects, there is a negative bias without selection because of the weighting by the phase II distribution. In comparison, selection increases the estimated probability of success. Thus, selection does not lead to a bias in probability of success if underestimation due to the phase II distribution and overestimation due to selection cancel each other out. We recommend to perform similar simulations in practice to get the necessary information about the risk and chances associated with such subgroup selection designs. Copyright © 2017 John Wiley & Sons, Ltd.

  13. Neutrinoless double beta decay in GERDA Phase II

    International Nuclear Information System (INIS)

    Macolino, C.

    2014-01-01

    The GERmanium Detector Array, GERDA, is designed to search for neutrinoless double beta (0νββ) decay of 76 Ge and it is installed in the Laboratori Nazionali del Gran Sasso (LNGS) of INFN, Italy. The GERDA experiment has completed the Phase I with a total collected exposure of 21.6 kg yr and a background index (BI) of the order of BI ≃ 10 −2 cts/(keVkg yr). No excess of events from 0νββ decay has been observed and a lower limit on the half-life on the 0νββ decay for 76 Ge has been estimated: T 0ν 1 /2 > 2.1·10 25 yr at 90% CL. The goal of GERDA Phase II is to reach the target sensitivity of T 0ν 1 /2 ≃ 1.4 · 10 26 yr, with an increased total mass of the enriched material and a reduced background level. In this paper the results from GERDA Phase I and the major improvements planned for Phase II are discussed.

  14. Mercury Oxidation via Catalytic Barrier Filters Phase II

    Energy Technology Data Exchange (ETDEWEB)

    Wayne Seames; Michael Mann; Darrin Muggli; Jason Hrdlicka; Carol Horabik

    2007-09-30

    In 2004, the Department of Energy National Energy Technology Laboratory awarded the University of North Dakota a Phase II University Coal Research grant to explore the feasibility of using barrier filters coated with a catalyst to oxidize elemental mercury in coal combustion flue gas streams. Oxidized mercury is substantially easier to remove than elemental mercury. If successful, this technique has the potential to substantially reduce mercury control costs for those installations that already utilize baghouse barrier filters for particulate removal. Completed in 2004, Phase I of this project successfully met its objectives of screening and assessing the possible feasibility of using catalyst coated barrier filters for the oxidation of vapor phase elemental mercury in coal combustion generated flue gas streams. Completed in September 2007, Phase II of this project successfully met its three objectives. First, an effective coating method for a catalytic barrier filter was found. Second, the effects of a simulated flue gas on the catalysts in a bench-scale reactor were determined. Finally, the performance of the best catalyst was assessed using real flue gas generated by a 19 kW research combustor firing each of three separate coal types.

  15. Advanced materials for future Phase II LHC collimators

    CERN Document Server

    Dallocchio, A; Arnau Izquierdo, G; Artoos, K

    2009-01-01

    Phase I collimators, equipped with Carbon-Carbon jaws, effectively met specifications for the early phase of LHC operation. However, the choice of carbon-based materials is expected to limit the nominal beam intensity mainly because of the high RF impedance and limited efficiency of the collimators. Moreover, C/C may be degraded by high radiation doses. To overcome these limitations, new Phase II secondary collimators will complement the existing system. Their extremely challenging requirements impose a thorough material investigation effort aiming at identifying novel materials combining very diverse properties. Relevant figures of merit have been identified to classify materials: Metal-diamonds composites look a promising choice as they combine good thermal, structural and stability properties. Molybdenum is interesting for its good thermal stability. Ceramics with non-conventional RF performances are also being evaluated. The challenges posed by the development and industrialization of these materials are ...

  16. 40 CFR 72.73 - State issuance of Phase II permits.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false State issuance of Phase II permits. 72.73 Section 72.73 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PERMITS REGULATION Acid Rain Phase II Implementation § 72.73 State issuance of Phase II permits...

  17. Search for neutrinoless double beta decay with GERDA phase II

    Science.gov (United States)

    Agostini, M.; Bakalyarov, A. M.; Balata, M.; Barabanov, I.; Baudis, L.; Bauer, C.; Bellotti, E.; Belogurov, S.; 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.; 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.; Csáthy, J. Janicskó; Jochum, J.; Junker, M.; Kazalov, V.; Kihm, T.; Kirpichnikov, I. V.; Kirsch, A.; Kish, A.; Klimenko, A.; Kneißl, R.; Knies, J.; Knöpfle, K. T.; Kochetov, O.; Kornoukhov, V. N.; Kuzminov, V. V.; Laubenstein, M.; Lazzaro, A.; Lebedev, V. I.; Liao, H. Y.; Lindner, M.; Lippi, I.; Lubashevskiy, A.; Lubsandorzhiev, B.; Lutter, G.; Majorovits, B.; Maneschg, W.; Marissens, G.; Miloradovic, M.; Mingazheva, R.; Misiaszek, M.; Moseev, P.; Nemchenok, I.; Panas, K.; Pandola, L.; Pelczar, K.; Pullia, A.; Ransom, C.; Reissfelder, M.; Riboldi, S.; Rumyantseva, N.; Sada, C.; Salamida, F.; Schmitt, C.; Schneider, B.; Schönert, S.; Schreiner, J.; Schulz, O.; Schütz, A.-K.; Schwingenheuer, B.; Seitz, H.; 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.; Zuber, K.; Zuzel, G.

    2017-10-01

    The GERmanium Detector Array (gerda) experiment, located at the Gran Sasso underground laboratory in Italy, is one of the leading experiments for the search of 0νββ decay. In Phase II of the experiment 35.6 kg of enriched germanium detectors are operated. The application of active background rejection methods, such as a liquid argon scintillation light read-out and pulse shape discrimination of germanium detector signals, allowed to reduce the background index to the intended level of 10-3 cts/(keV.kg.yr). In the first five month of data taking 10.8 kg yr of exposure were accumulated. No signal has been found and together with data from Phase I a new limit for the neutrinoless double beta decay half-life of 76Ge of 5.3 . 1025 yr at 90% C.L. was established in June 2016. Phase II data taking is ongoing and will allow the exploration of half-lifes in the 1026 yr regime. The current status of data taking and an update on the background index are presented.

  18. Searching Neutrinoless Double Beta Decay with GERDA Phase II

    Science.gov (United States)

    Agostini, M.; Bakalyarov, A. M.; Balata, M.; Barabanov, I.; Baudis, L.; Bauer, C.; Bellotti, E.; Belogurov, S.; Bettini, A.; Bezrukov, L.; Bode, T.; Brudanin, V.; Brugnera, R.; Caldwell, A.; Cattadori, C.; Chernogorov, A.; Comellato, T.; D’Andrea, V.; Demidova, E. V.; di Marco, N.; Domula, A.; Doroshkevich, E.; Egorov, V.; Falkenstein, R.; Gangapshev, A.; Garfagnini, A.; Giordano, M.; Gooch, C.; Grabmayr, P.; Gurentsov, V.; Gusev, K.; Hahne, C.; Hakenmüller, J.; Hegai, A.; Heisel, M.; Hemmer, S.; Hiller, R.; Hofmann, W.; Holl, P.; Hult, M.; Inzhechik, L. V.; Ioannucci, L.; Csáthy, J. Janicskó; Jochum, J.; Junker, M.; Kazalov, V.; Kermaidic, 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.; Lindner, M.; Lippi, I.; Lubashevskiy, A.; Lubsandorzhiev, B.; Lutter, G.; Macolino, C.; Majorovits, B.; Maneschg, W.; Marissens, G.; Miloradovic, M.; Mingazheva, R.; Misiaszek, M.; Moseev, P.; Nemchenok, I.; Nisi, S.; Panas, K.; Pandola, L.; Pelczar, K.; Pullia, A.; Ransom, C.; Reissfelder, M.; Riboldi, S.; Rumyantseva, N.; Sada, C.; Sala, E.; Salamida, F.; Schmitt, C.; Schneider, B.; Schreiner, J.; Schulz, O.; Schweisshelm, B.; Schwingenheuer, B.; Schönert, S.; Schütz, A.-K.; Seitz, H.; 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.; Zschocke, A.; Zsigmond, A. J.; Zuber, K.; Zuzel, G.

    An observation of neutrinoless double beta (0νββ) decay would allow to shed light onto the nature of neutrinos. GERDA (GERmanium Detector Array) aims to discover this process in a background-free search using 76Ge. The experiment is located at the Laboratori Nazionali del Gran Sasso (LNGS) of the Istituto Nazionale di Fisica Nucleare (INFN) in Italy. Bare, isotopically enriched, high purity germanium detectors are operated in liquid argon. GERDA follows a staged approach. In Phase II 35.6 kg of enriched germanium detectors are operated since December 2015. The application of active background rejection methods, such as a liquid argon scintillation light read-out and pulse shape discrimination of germanium detector signals, allows to reduce the background index to the intended level of 10‑3 cts/(keVṡkgṡyr). No evidence for the 0νββ decay has been found in 23.2 kgṡyr of Phase II data, and together with data from Phase I the up-to-date most stringent half-life limit for this process in 76Ge has been established, at a median sensitivity of 5.8ṡ1025yr the 90% C.L. lower limit is 8.0ṡ1025yr.

  19. Reduction in chlorhexidine efficacy against multi-drug-resistant Acinetobacter baumannii international clone II.

    Science.gov (United States)

    Hayashi, M; Kawamura, K; Matsui, M; Suzuki, M; Suzuki, S; Shibayama, K; Arakawa, Y

    2017-03-01

    Nosocomial infections caused by Acinetobacter baumannii international clone II (IC II) can cause severe clinical outcomes. Differential evaluation of bactericidal efficacy of chlorhexidine gluconate (CHX) and benzethonium chloride (BZT) disinfectants against IC II and non-IC II isolates. Minimum inhibitory concentrations (MICs) of CHX and BZT were determined for 137 A. baumannii IC II, 99 non-IC II and 69 non-baumannii isolates, further classified according to MIC values into disinfectant-reduced susceptible (DRS) and disinfectant-susceptible (DS) groups. Time-kill curves and minimum bactericidal concentrations (MBCs) were evaluated for representative isolates in each group. CHX and BZT MIC 90 s for IC II isolates were 100 and 175mg/L, respectively, but those for non-IC II and non-baumannii isolates were <100mg/L. Nevertheless, time-kill curves indicated that CHX and BZT reduced live bacterial cell number by 5 log 10 for IC II and non-IC II isolates within 30s when used at 1000mg/L, comparable to practical use concentrations. CHX MBC at 30s was 1000mg/L for IC II and non-IC II isolates, and was not influenced by addition of 3% bovine serum albumin (BSA); BZT MBC at 30s was 100mg/L without BSA and increased up to 500mg/L upon addition of BSA. No significant differences in BSA were found between DRS and DS isolates. CHX and BZT were effective against Acinetobacter spp. including IC II at a concentration of 1000mg/L and exposure for at least 30s, but their concentrations should be considered carefully to ensure sufficient effects in both clinical and healthcare settings. Copyright © 2016 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

  20. NNWSI Phase II materials interaction test procedure and preliminary results

    International Nuclear Information System (INIS)

    Bates, J.K.; Gerding, T.J.

    1985-01-01

    The Nevada Nuclear Waste Storage Investigations (NNWSI) project is investigating the volcanic tuff beds of Yucca Mountain, Nevada, as a potential location for a high-level radioactive waste repository. This report describes a test method (Phase II) that has been developed to measure the release of radionuclides from the waste package under simulated repository conditions, and provides information on materials interactions that may occur in the repository. The results of 13 weeks of testing using the method are presented, and an analog test is described that investigates the relationship between the test method and expected repository conditions. 9 references, 10 figures, 11 tables

  1. ATCA - thermal management study for the ATLAS phase II upgrades

    CERN Document Server

    Bortolin, Claudio; Kalinowski, Michal; Koziol, Piotr; Mendez, Julian; Walerianczyk, Jan; Zwalinski, Lukasz

    2017-01-01

    The AdvancedTCA (ATCA) telecom industry standard has been selected as the hardware platform for the “Phase-II Upgrade” of ATLAS at the Large Hadron Collider (LHC) at CERN. In November 2014 a project dedicated to the study of the impact of the ATCA integration in the actual counting rooms was launched analysing the impact on the cooling infrastructures. A spare rack equipped with two ATCA shelves, high power dissipating load blades, temperature and air velocity sensors were installed in a lab. Vertical and horizontal cooling performance were checked and some crtitical aspects identified.

  2. Improved nuclear gage development - phase i and ii. Interim report

    International Nuclear Information System (INIS)

    Chan, E.L.; Champion, F.C.; Castanon, D.R.; Chang, J.C.; Hannon, J.B.

    1976-09-01

    This report contains Phase I and II of an investigation covering the design and construction of a prototype nuclear-moisture-density backscatter gage. Gage development was based upon the analysis of several factors which affect gage performance. This research indicated that the prototype gage measurements are approximately equivalent to measurements obtained by a commercial transmission gage. The implication of this research finding concerns the qualification of the backscatter test method as a valid, reliable, and expedient procedure for determining in-situ soil conditions

  3. ATCA - thermal management study for the ATLAS phase II upgrades

    OpenAIRE

    Bortolin, Claudio; Dyngosz, Damian; Kalinowski, Michal; Koziol, Piotr; Mendez, Julian; Walerianczyk, Jan; Zwalinski, Lukasz

    2017-01-01

    The AdvancedTCA (ATCA) telecom industry standard has been selected as the hardware platform for the “Phase-II Upgrade” of ATLAS at the Large Hadron Collider (LHC) at CERN. In November 2014 a project dedicated to the study of the impact of the ATCA integration in the actual counting rooms was launched analysing the impact on the cooling infrastructures. A spare rack equipped with two ATCA shelves, high power dissipating load blades, temperature and air velocity sensors were installed in a lab....

  4. Physics Detector Simulation Facility Phase II system software description

    International Nuclear Information System (INIS)

    Scipioni, B.; Allen, J.; Chang, C.; Huang, J.; Liu, J.; Mestad, S.; Pan, J.; Marquez, M.; Estep, P.

    1993-05-01

    This paper presents the Physics Detector Simulation Facility (PDSF) Phase II system software. A key element in the design of a distributed computing environment for the PDSF has been the separation and distribution of the major functions. The facility has been designed to support batch and interactive processing, and to incorporate the file and tape storage systems. By distributing these functions, it is often possible to provide higher throughput and resource availability. Similarly, the design is intended to exploit event-level parallelism in an open distributed environment

  5. FALSIRE Phase II. CSNI project for Fracture Analyses of Large-Scale International Reference Experiments (Phase II). Comparison report

    International Nuclear Information System (INIS)

    Sievers, J.; Schulz, H.; Bass, R.; Pugh, C.; Keeney, J.

    1996-11-01

    A summary of Phase II of the Project for Fracture Analysis of Large-Scale International Reference Experiments (FALSIRE) is presented. A FALSIRE II Workshop focused on analyses of reference fracture experiments. More than 30 participants representing 22 organizations from 12 countries took part in the workshop. Final results for 45 analyses of the reference experiments were received from the participating analysts. For each experiment, analysis results provided estimates of variables that include temperature, crack-mouth-opening displacement, stress, strain, and applied K and J values. The data were sent electronically to the Organizing Committee, who assembled the results into a comparative data base using a special-purpose computer program. A comparative assessment and discussion of the analysis results are presented in the report. Generally, structural responses of the test specimens were predicted with tolerable scatter bands. (orig./DG)

  6. The Relationship Between Self-Efficacy and Sexual Function in Patients with Type II Diabetes

    Directory of Open Access Journals (Sweden)

    Samira Haddadi

    2016-09-01

    Full Text Available Background: Diabetes is a common chronic disease that is increasingly observed in almost all countries of the world. The treatment and prevention of diabetes largely depend on patients’ self-efficacy in performing self-care behaviors. Accordingly, the present study was conducted to examine the relationship between self-efficacy and sexual performance in patients with type II diabetes. Methods: In the present correlational study, 200 patients with type II diabetes (based on physicians’ diagnosis participated. Using convenience sampling method, the samples were selected out of the whole population of diabetic patients who referred to Shahid Bahonar and Rajaei Hospitals in the city of Karaj (Iran. The data were collected through a multi-faceted questionnaire covering demographic characteristics of the participants, the Diabetes Management Self-Efficacy Scale (DMSES, the Female Sexual Function Index (FSFI and the Male Sexual Function Index (MSFI. Then, the collected data were analyzed through Pearson correlation test, multiple linear regression analysis, independent t-test and ANOVA. Results: The results showed a positive significant relationship between self-efficacy and sexual function (p<0.001; regression coefficient of the predictor variable ‘self-efficacy’ was 0.217 (p<0.017. Conclusion:  Self-efficacy plays an important role in the lives of diabetic patients; it is also important in sexual performance of diabetic patients. Therefore, based on the results of this study, the significant relationship between self-efficacy and sexual function must be considered in the treatment of patients with type II diabetes.

  7. [Fungal community structure in phase II composting of Volvariella volvacea].

    Science.gov (United States)

    Chen, Changqing; Li, Tong; Jiang, Yun; Li, Yu

    2014-12-04

    To understand the fungal community succession during the phase II of Volvariella volvacea compost and clarify the predominant fungi in different fermentation stages, to monitor the dynamic compost at the molecular level accurately and quickly, and reveal the mechanism. The 18S rDNA-denaturing gradient gel electrophoresis (DGGE) and sequencing methods were used to analyze the fungal community structure during the course of compost. The DGGE profile shows that there were differences in the diversity of fungal community with the fermentation progress. The diversity was higher in the stages of high temperature. And the dynamic changes of predominant community and relative intensity was observed. Among the 20 predominant clone strains, 9 were unknown eukaryote and fungi, the others were Eurotiales, Aspergillus sp., Melanocarpus albomyces, Colletotrichum sp., Rhizomucor sp., Verticillium sp., Penicillium commune, Microascus trigonosporus and Trichosporon lactis. The 14 clone strains were detected in the stages of high and durative temperature. The fungal community structure and predominant community have taken dynamic succession during the phase II of Volvariella volvacea compost.

  8. Test Plan for Hydrogen Getters Project - Phase II

    International Nuclear Information System (INIS)

    Mroz, G.

    1999-01-01

    Hydrogen levels in many transuranic (TRU) waste drums are above the compliance threshold, therefore deeming the drums non-shippable to the Waste Isolation Pilot Plant (WIPP). Hydrogen getters (alkynes and dialkynes) are known to react irreversibly with hydrogen in the presence of certain catalysts. The primary purpose of this investigation is to ascertain the effectiveness of a hydrogen getter in an environment that contains gaseous compounds commonly found in the headspace of drums containing TRU waste. It is not known whether the volatile organic compounds (VOCs) commonly found in the headspace of TRU waste drums will inhibit (''poison'') the effectiveness of the hydrogen getter. The result of this study will be used to assess the feasibility of a hydrogen-getter system, which is capable of removing hydrogen from the payload containers or the Transuranic Package Transporter-II (TRUPACT-II) inner containment vessel to increase the quantity of TRU waste that can be shipped to the WIPP. Phase II for the Hydrogen Getters Project will focus on four primary objectives: Conduct measurements of the relative permeability of hydrogen and chlorinated VOCs through Tedlar (and possibly other candidate packaging materials) Test alternative getter systems as alternatives to semi-permeable packaging materials. Candidates include DEB/Pd/Al2O3 and DEB/Cu-Pd/C. Develop, test, and deploy kinetic optimization model Perform drum-scale test experiments to demonstrate getter effectiveness

  9. Single Photon Sensitive HgCdTe Avalanche Photodiode Detector (APD), Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Leveraging Phase I SBIR successes, in Phase II, a single photon sensitive LIDAR receiver will be fabricated and delivered to NASA. In Phase I, high-gain,...

  10. Pipe Overpack Container Fire Testing: Phase I II & III.

    Energy Technology Data Exchange (ETDEWEB)

    Figueroa, Victor G. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Ammerman, Douglas J. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Lopez, Carlos [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Gill, Walter [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2018-02-01

    The Pipe Overpack Container (POC) was developed at Rocky Flats to transport plutonium residues with higher levels of plutonium than standard transuranic (TRU) waste to the Waste Isolation Pilot Plant (WIPP) for disposal. In 1996 Sandia National Laboratories (SNL) conducted a series of tests to determine the degree of protection POCs provided during storage accident events. One of these tests exposed four of the POCs to a 30-minute engulfing pool fire, resulting in one of the 7A drum overpacks generating sufficient internal pressure to pop off its lid and expose the top of the pipe container (PC) to the fire environment. The initial contents of the POCs were inert materials, which would not generate large internal pressure within the PC if heated. POCs are now being used to store combustible TRU waste at Department of Energy (DOE) sites. At the request of DOE’s Office of Environmental Management (EM) and National Nuclear Security Administration (NNSA), starting in 2015 SNL conducted a series of fire tests to examine whether PCs with combustibles would reach a temperature that would result in (1) decomposition of inner contents and (2) subsequent generation of sufficient gas to cause the PC to over-pressurize and release its inner content. Tests conducted during 2015 and 2016 were done in three phases. The goal of the first phase was to see if the PC would reach high enough temperatures to decompose typical combustible materials inside the PC. The goal of the second test phase was to determine under what heating loads (i.e., incident heat fluxes) the 7A drum lid pops off from the POC drum. The goal of the third phase was to see if surrogate aerosol gets released from the PC when the drum lid is off. This report will describe the various tests conducted in phase I, II, and III, present preliminary results from these tests, and discuss implications for the POCs.

  11. Efficacy of MTA and CEM Cement with Collagen Membranes for Treatment of Class II Furcation Defects.

    Directory of Open Access Journals (Sweden)

    Habib Ollah Ghanbari

    2014-06-01

    Full Text Available This study aimed to compare the efficacy of MTA and CEM cement in Class II furcation defects in human mandibular molars.Forty furcation defects were treated in 16 patients with chronic periodontitis. The clinical parameters of probing depth (PD, vertical and horizontal clinical attachment levels (VCAL and HCAL, open vertical and horizontal furcation depths (OVFD and OHFD, and gingival margin level (GML were measured at baseline and at 3- and 6-month (re-entry surgery postoperatively. Data were analyzed at a significance level of P<0.05.Use of MTA and CEM caused significant decreases in PD, VCAL, HCAL, OVFD and OHFD at re-entry, with no statistically significant differences between the two treatment options in soft and hard tissue parameters.Both treatment modalities caused significant gains in attachment levels and bone fills, proving efficacy for treatment of Class II furcation involvements.

  12. The potential of SGLT2 inhibitors in phase II clinical development for treating type 2 diabetes.

    Science.gov (United States)

    Pafili, K; Maltezos, E; Papanas, N

    2016-10-01

    There is now an abundance of anti-diabetic agents. However, only few patients achieve glycemic targets. Moreover, current glucose-lowering agents mainly depend upon insulin secretion or function. Sodium glucose co-transporter type 2 (SGLT2) inhibitors present a novel glucose-lowering therapy, inducing glycosuria in an insulin-independent fashion. In this review, the authors discuss the key efficacy and safety data from phase II clinical trials in type 2 diabetes mellitus (T2DM) of the main SGLT2 inhibitors approved or currently in development, and provide a rationale for their use in T2DM. Despite the very promising characteristics of this new therapeutic class, a number of issues await consideration. One important question is what to expect from head-to-head comparison data. We also need to know if dual inhibition of SGLT1/SGLT2 is more efficacious in reducing HbA1c and how this therapy affects metabolic and cardiovascular parameters. Additionally, several SGLT2 agents that have not yet come to market have hitherto been evaluated in Asian populations, whereas approved SGLT2 inhibitors have been frequently studied in other populations, including Caucasian subjects. Thus, we need more information on the potential role of ethnicity on their efficacy and safety.

  13. A phase I/II clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced cervical cancer.

    Science.gov (United States)

    Murakami, Naoya; Kato, Shingo; Nakano, Takashi; Uno, Takashi; Yamanaka, Takeharu; Sakurai, Hideyuki; Yoshimura, Ryoichi; Hiratsuka, Junichi; Kuroda, Yuki; Yoshio, Kotaro; Itami, Jun

    2016-08-17

    This paper describes about a study protocol of phase I/II multicenter prospective clinical trial evaluating the feasibility and efficacy of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced uterine cervical cancer patients. Patients with histologically confirmed FIGO stage IB2, IIA2, IIB, and IIIB uterine cervical carcinoma width of which is larger than 5 cm assessed by MRI will be entered to this clinical trial. Protocol therapy is 30-30.6 Gy in 15-17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP (40 mg/m(2)), followed by 24 Gy in 4 fractions of HBT and central shield EBRT up to 50-50.4 Gy in 25-28 fractions. Tumor width is assessed again within one week before the first HBT and if the tumor width is larger than 4 cm, patients proceed to the secondary registration. In phase I section, feasibility of this will be investigated. If less than 10 % out of 20 patients experienced greater than grade 3 acute non-hematologic adverse effects, the study proceeds to phase II part. In phase II part a total of 55 patients will be accrued and the efficacy of the HBT will be investigated comparing with historical control data. If the lower margin of 90 % confidence interval of the 2-year pelvic progression-free survival of the HBT trial is higher than 64 %, the HBT is considered to be more effective than conventional ICBT. The aim of this study is to demonstrate the feasibility and efficacy of the HBT for locally advanced cervical cancer. This trial will clarify the indication, feasibility, and efficacy of this new technique. UMIN000019081 ; Registration date: 2015/9/30.

  14. Implementation of neutron phase contrast imaging at FRM-II

    Energy Technology Data Exchange (ETDEWEB)

    Lorenz, Klaus

    2008-11-12

    At ANTARES, the beam line for neutron imaging at the Forschungsneutronenquelle Heinz Maier-Leibnitz (FRM-II) in Garching, the option to do phase contrast imaging besides conventional absorption based neutron imaging was implemented and successfully used for the non-destructive testing of various types of objects. The used propagation-based technique is based on the interference of neutron waves in the detector plane that were differently strong diffracted by the sample. A comparison with other phase-sensitive neutron imaging techniques highlights assets and drawbacks of the different methods. In preliminary measurements at ANTARES and the spallation source SINQ at PSI in Villigen, the influence of the beam geometry, the neutron spectrum and the detector on the quality of the phase contrast measurements were investigated systematically. It was demonstrated that gamma radiation and epithermal neutrons in the beam contribute severely to background noise in measurements, which motivated the installation of a remotely controlled filter wheel for a quick and precise positioning of different crystal filters in the beam. By the installation of a similar aperture wheel, a quick change between eight different beam geometries was made possible. Besides pinhole and slit apertures, coded apertures based on non redundant arrays were investigated. The possibilities, which arise by the exploitation of the real part of the refractive index in neutron imaging, were demonstrated in experiments with especially designed test samples and in measurements with ordinary, industrial components. (orig.)

  15. Implementation of neutron phase contrast imaging at FRM-II

    International Nuclear Information System (INIS)

    Lorenz, Klaus

    2008-01-01

    At ANTARES, the beam line for neutron imaging at the Forschungsneutronenquelle Heinz Maier-Leibnitz (FRM-II) in Garching, the option to do phase contrast imaging besides conventional absorption based neutron imaging was implemented and successfully used for the non-destructive testing of various types of objects. The used propagation-based technique is based on the interference of neutron waves in the detector plane that were differently strong diffracted by the sample. A comparison with other phase-sensitive neutron imaging techniques highlights assets and drawbacks of the different methods. In preliminary measurements at ANTARES and the spallation source SINQ at PSI in Villigen, the influence of the beam geometry, the neutron spectrum and the detector on the quality of the phase contrast measurements were investigated systematically. It was demonstrated that gamma radiation and epithermal neutrons in the beam contribute severely to background noise in measurements, which motivated the installation of a remotely controlled filter wheel for a quick and precise positioning of different crystal filters in the beam. By the installation of a similar aperture wheel, a quick change between eight different beam geometries was made possible. Besides pinhole and slit apertures, coded apertures based on non redundant arrays were investigated. The possibilities, which arise by the exploitation of the real part of the refractive index in neutron imaging, were demonstrated in experiments with especially designed test samples and in measurements with ordinary, industrial components. (orig.)

  16. Advanced Simulation Capability for Environmental Management (ASCEM) Phase II Demonstration

    Energy Technology Data Exchange (ETDEWEB)

    Freshley, M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Hubbard, S. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Flach, G. [Savannah River National Lab. (SRNL), Aiken, SC (United States); Freedman, V. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Agarwal, D. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Andre, B. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Bott, Y. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Chen, X. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Davis, J. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Faybishenko, B. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Gorton, I. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Murray, C. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Moulton, D. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States); Meyer, J. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Rockhold, M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Shoshani, A. [LBNL; Steefel, C. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Wainwright, H. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); Waichler, S. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2012-09-28

    quality assurance. The Platform and HPC capabilities are being tested and evaluated for EM applications through a suite of demonstrations being conducted by the Site Applications Thrust. In 2010, the Phase I Demonstration focused on testing initial ASCEM capabilities. The Phase II Demonstration, completed in September 2012, focused on showcasing integrated ASCEM capabilities. For Phase II, the Hanford Site Deep Vadose Zone (BC Cribs) served as an application site for an end-to-end demonstration of ASCEM capabilities on a site with relatively sparse data, with emphasis on integration and linkages between the Platform and HPC components. Other demonstrations included in this Phase II report included addressing attenuation-based remedies at the Savannah River Site F-Area, to exercise linked ASCEM components under data-dense and complex geochemical conditions, and conducting detailed simulations of a representative waste tank. This report includes descriptive examples developed by the Hanford Site Deep Vadose Zone, the SRS F-Area Attenuation-Based Remedies for the Subsurface, and the Waste Tank Performance Assessment working groups. The integrated Phase II Demonstration provides test cases to accompany distribution of the initial user release (Version 1.0) of the ASCEM software tools to a limited set of users in 2013. These test cases will be expanded with each new release, leading up to the release of a version that is qualified for regulatory applications in the 2015 time frame.

  17. Phase II Vault Testing of the Argonne RFID System

    International Nuclear Information System (INIS)

    Willoner, T.; Turlington, R.; Koenig, R.

    2012-01-01

    The U.S. Department of Energy (DOE) (Environmental Management (EM), Office of Packaging and Transportation (EM-45)) Packaging and Certification Program (DOE PCP) has developed a Radio Frequency Identification (RFID) tracking and monitoring system, called ARG-US, for the management of nuclear materials packages during transportation and storage. The performance of the ARG-US RFID equipment and system has been fully tested in two demonstration projects in April 2008 and August 2009. With the strong support of DOE-SR and DOE PCP, a field testing program was completed in Savannah River Site's K-Area Material Storage (KAMS) Facility, an active Category I Plutonium Storage Facility, in 2010. As the next step (Phase II) of continued vault testing for the ARG-US system, the Savannah River Site K Area Material Storage facility has placed the ARG-US RFIDs into the 910B storage vault for operational testing. This latest version (Mark III) of the Argonne RFID system now has the capability to measure radiation dose and dose rate. This paper will report field testing progress of the ARG-US RFID equipment in KAMS, the operability and reliability trend results associated with the applications of the system, and discuss the potential benefits in enhancing safety, security and materials accountability. The purpose of this Phase II K Area test is to verify the accuracy of the radiation monitoring and proper functionality of the ARG-US RFID equipment and system under a realistic environment in the KAMS facility. Deploying the ARG-US RFID system leads to a reduced need for manned surveillance and increased inventory periods by providing real-time access to status and event history traceability, including environmental condition monitoring and radiation monitoring. The successful completion of the testing program will provide field data to support a future development and testing. This will increase Operation efficiency and cost effectiveness for vault operation. As the next step (Phase

  18. PHASE II VAULT TESTING OF THE ARGONNE RFID SYSTEM

    Energy Technology Data Exchange (ETDEWEB)

    Willoner, T.; Turlington, R.; Koenig, R.

    2012-06-25

    The U.S. Department of Energy (DOE) (Environmental Management [EM], Office of Packaging and Transportation [EM-45]) Packaging and Certification Program (DOE PCP) has developed a Radio Frequency Identification (RFID) tracking and monitoring system, called ARG-US, for the management of nuclear materials packages during transportation and storage. The performance of the ARG-US RFID equipment and system has been fully tested in two demonstration projects in April 2008 and August 2009. With the strong support of DOE-SR and DOE PCP, a field testing program was completed in Savannah River Site's K-Area Material Storage (KAMS) Facility, an active Category I Plutonium Storage Facility, in 2010. As the next step (Phase II) of continued vault testing for the ARG-US system, the Savannah River Site K Area Material Storage facility has placed the ARG-US RFIDs into the 910B storage vault for operational testing. This latest version (Mark III) of the Argonne RFID system now has the capability to measure radiation dose and dose rate. This paper will report field testing progress of the ARG-US RFID equipment in KAMS, the operability and reliability trend results associated with the applications of the system, and discuss the potential benefits in enhancing safety, security and materials accountability. The purpose of this Phase II K Area test is to verify the accuracy of the radiation monitoring and proper functionality of the ARG-US RFID equipment and system under a realistic environment in the KAMS facility. Deploying the ARG-US RFID system leads to a reduced need for manned surveillance and increased inventory periods by providing real-time access to status and event history traceability, including environmental condition monitoring and radiation monitoring. The successful completion of the testing program will provide field data to support a future development and testing. This will increase Operation efficiency and cost effectiveness for vault operation. As the next step

  19. Pipe Overpack Container Fire Testing: Phase I & II

    Energy Technology Data Exchange (ETDEWEB)

    Figueroa, Victor G. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Ammerman, Douglas J. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Lopez, Carlos [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Gill, Walter [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2017-05-01

    The Pipe Overpack Container (POC) was developed at Rocky Flats to transport plutonium residues with higher levels of plutonium than standard transuranic (TRU) waste to the Waste Isolation Pilot Plant (WIPP) for disposal. In 1996 Sandia National Laboratories (SNL) conducted a series of tests to determine the degree of protection POCs provided during storage accident events. One of these tests exposed four of the POCs to a 30-minute engulfing pool fire, resulting in one of the 7A drum overpacks generating sufficient internal pressure to pop off its lid and expose the top of the pipe container (PC) to the fire environment. The initial contents of the POCs were inert materials, which would not generate large internal pressure within the PC if heated. However, POCs are now being used to store combustible TRU waste at Department of Energy (DOE) sites. At the request of DOE’s Office of Environmental Management (EM) and National Nuclear Security Administration (NNSA), starting in 2015 SNL conducted a new series of fire tests to examine whether PCs with combustibles would reach a temperature that would result in (1) decomposition of inner contents and (2) subsequent generation of sufficient gas to cause the PC to over-pressurize and release its inner content. Tests conducted during 2015 and 2016, and described herein, were done in two phases. The goal of the first phase was to see if the PC would reach high enough temperatures to decompose typical combustible materials inside the PC. The goal of the second test phase was to determine under what heating loads (i.e., incident heat fluxes) the 7A drum lid pops off from the POC drum. This report will describe the various tests conducted in phase I and II, present preliminary results from these tests, and discuss implications for the POCs.

  20. Lunar Quest in Second Life, Lunar Exploration Island, Phase II

    Science.gov (United States)

    Ireton, F. M.; Day, B. H.; Mitchell, B.; Hsu, B. C.

    2010-12-01

    Linden Lab’s Second Life is a virtual 3D metaverse created by users. At any one time there may be 40,000-50,000 users on line. Users develop a persona and are seen on screen as a human figure or avatar. Avatars move through Second Life by walking, flying, or teleporting. Users form communities or groups of mutual interest such as music, computer graphics, and education. These groups communicate via e-mail, voice, and text within Second Life. Information on downloading the Second Life browser and joining can be found on the Second Life website: www.secondlife.com. This poster details Phase II in the development of Lunar Exploration Island (LEI) located in Second Life. Phase I LEI highlighted NASA’s LRO/LCROSS mission. Avatars enter LEI via teleportation arriving at a hall of flight housing interactive exhibits on the LRO/ LCROSS missions including full size models of the two spacecraft and launch vehicle. Storyboards with information about the missions interpret the exhibits while links to external websites provide further information on the mission, both spacecraft’s instrument suites, and related EPO. Other lunar related activities such as My Moon and NLSI EPO programs. A special exhibit was designed for International Observe the Moon Night activities with links to websites for further information. The sim includes several sites for meetings, a conference stage to host talks, and a screen for viewing NASATV coverage of mission and other televised events. In Phase II exhibits are updated to reflect on-going lunar exploration highlights, discoveries, and future missions. A new section of LEI has been developed to showcase NASA’s Lunar Quest program. A new exhibit hall with Lunar Quest information has been designed and is being populated with Lunar Quest information, spacecraft models (LADEE is in place) and kiosks. A two stage interactive demonstration illustrates lunar phases with static and 3-D stations. As NASA’s Lunar Quest program matures further

  1. Small Business Innovation Research. Abstracts of Phase II awards, 2000

    Energy Technology Data Exchange (ETDEWEB)

    None

    2000-12-01

    The SBIR program enables DOE to obtain effective, innovative solutions to important problems through the private sector, which has a commercial incentive to pursue the resulting technology and bring it to the marketplace. The growing number of awardees, many of them started in business in response to SBIR solicitations, is becoming a significant resource for the solution of high risk, high technology problems for the Department. As detailed below, this publication describes the technical efforts and commercialization possibilities for SBIR Phase II awards in Fiscal Year (FY) 2000. It is intended for the educated layman, and maybe of particular interest to potential investors who wish to get in on the ground floor of exciting opportunities.

  2. The NEA Forum on Stakeholder Confidence - Phase I Lessons and Phase II Activities

    Energy Technology Data Exchange (ETDEWEB)

    Brown, Peter [Natural Resources Canada, Ottawa (Canada). Uranium and Radioactive Waste Div.; Pescatore, Claudio [Nuclear Energy Agency, Paris (France)

    2006-09-15

    The Forum on Stakeholder Confidence (FSC) was created under a mandate from the OECD Nuclear Energy Agency (NEA) Radioactive Waste Management Committee (RWMC) to facilitate the sharing of international experience in addressing the societal dimension of radioactive waste management. It explores means of ensuring an effective dialogue with the public, and considers ways to strengthen confidence in decision-making processes. The Forum was launched in August 2000 and completed its first phase in 00 . Major findings and principles for action were published under the title of 'Learning and Adapting to Societal Requirements'. Activities of the FSC were also reported at Valdor 2003. In the second mandate of the FSC, there is continued use of a variety of tools and formats to allow dialogue among stakeholders in an atmosphere of mutual trust: national workshops and community visits, topical sessions, and desk and interview studies. In Phase II, the FSC is exploring: the link between research, development and demonstration and stakeholder confidence; cultural and organisational changes in RWM institutions; the role of media relations and outreach opportunities; tools and processes to help society prepare and manage decisions through stakeholder involvement; and increasing the value of waste management facilities to local communities. Workshops have been held in Germany and Spain. A large set of publications makes both Phase I and Phase II findings widely available.

  3. The NEA Forum on Stakeholder Confidence - Phase I Lessons and Phase II Activities

    International Nuclear Information System (INIS)

    Brown, Peter

    2006-01-01

    The Forum on Stakeholder Confidence (FSC) was created under a mandate from the OECD Nuclear Energy Agency (NEA) Radioactive Waste Management Committee (RWMC) to facilitate the sharing of international experience in addressing the societal dimension of radioactive waste management. It explores means of ensuring an effective dialogue with the public, and considers ways to strengthen confidence in decision-making processes. The Forum was launched in August 2000 and completed its first phase in 00 . Major findings and principles for action were published under the title of 'Learning and Adapting to Societal Requirements'. Activities of the FSC were also reported at Valdor 2003. In the second mandate of the FSC, there is continued use of a variety of tools and formats to allow dialogue among stakeholders in an atmosphere of mutual trust: national workshops and community visits, topical sessions, and desk and interview studies. In Phase II, the FSC is exploring: the link between research, development and demonstration and stakeholder confidence; cultural and organisational changes in RWM institutions; the role of media relations and outreach opportunities; tools and processes to help society prepare and manage decisions through stakeholder involvement; and increasing the value of waste management facilities to local communities. Workshops have been held in Germany and Spain. A large set of publications makes both Phase I and Phase II findings widely available

  4. Phase I Report, US DOE GRED II Program

    Energy Technology Data Exchange (ETDEWEB)

    Fairbank Engineering Ltd.

    2003-04-23

    Noramex Corporation Inc, a Nevada company, owns a 100% interest in geothermal leases at the Blue Mountain Geothermal Area, Humboldt County, Nevada. The company is exploring the site for a geothermal resource suitable for development for electric power generation or In the spring of 2002, Noramex drilled the first geothermal observation hole at Blue Mountain, under a cost-share program with the U.S Department of Energy (DOE), under the DOE's Geothermal Exploration and Resource Definition (GRED) program, (Cooperative Agreement No. DE-FC04-00AL66972). DEEP BLUE No.1 was drilled to a total depth of 672.1 meters (2205 feet) and recorded a maximum temperature of 144.7 C (292.5 F). Noramex Corporation will now drill a second slim geothermal observation test hole at Blue Mountain, designated DEEP BLUE No.2. The hole will be drilled under a cost-share program with the DOE, under the DOE's Geothermal Exploration and Resource Definition II (GRED II) program, (Cooperative Agreement No. DE-FC04-2002AL68297). This report comprises Phase I of Cooperative Agreement No. DE-FC04-2002AL68297 of the GRED II program. The report provides an update on the status of resource confirmation at the Blue Mountain Geothermal Area, incorporating the results from DEEP BLUE No.1, and provides the technical background for a second test hole. The report also outlines the proposed drilling program for slim geothermal observation test hole DEEP BLUE No.2.

  5. Phase II drugs currently being investigated for the treatment of hypogonadism.

    Science.gov (United States)

    Udedibia, Emeka; Kaminetsky, Jed

    2014-12-01

    Hypogonadism is the most common endocrine disorder, which affects men of all age groups. Recent shifts in public awareness, increased screening and recognition of symptoms and updated diagnostic criteria have led to an increase in men diagnosed as hypogonadal, including middle-aged and older men who previously would have been considered eugonadal. The increase in testosterone replacement therapy (TRT) has paralleled an increase in advancements of treatment options. Although current therapies are highly efficacious for many men, there remains a need for newer therapies that are more cost-effective, preserve ease of use and administration, mitigate undesirable effects and closely mimic physiological levels of testosterone. In this review, the authors discuss current TRTs and therapies in development for the treatment of hypogonadism. The focus is on therapies under Phase II investigation or those who have recently completed Phase II study. With several new therapies in development, the authors expect advancements in achieving treatment benchmarks that meet the needs of the individual symptomatic hypogonadal male. Increased public awareness of hypogonadism and TRT has led to a welcomed expansion in the choice of TRT options. These include new delivery systems, formulations, routes of administration and non-testosterone modalities.

  6. Phase II study of oral platinum drug JM216 as first-line treatment in patients with small-cell long cancer

    NARCIS (Netherlands)

    Fokkema, E; Groen, HJM; Uges, DRA; Weil, C; Smith, IE

    1999-01-01

    Purpose: This multicenter phase II trial wets performed to determine tumor efficacy and tolerance of the oral platinum drug JM216 in patients with small-cell lung cancer (SCLC). Patients and Methods: patients with SCLC limited disease unfit for intensive chemotherapy or those with extensive disease

  7. Phase II Trial of Metronomic Chemotherapy as Salvage Therapy for Patients with Metastatic Breast Cancer

    International Nuclear Information System (INIS)

    SALEM, D.A.; GADO, N.M.; ABDELAZIZ, N.N.; ESSA, A.E.; ABDELHAFEEZ, Z.M.; KAMEL, T.H.

    2008-01-01

    Aim of Work: To evaluate the efficacy and tolerability of metronomic chemotherapy (which is the continuous administration of chemotherapy at relatively low minimally toxic doses on a frequent schedule of administration at close regular intervals with no prolonged drug-free breaks) in metastatic breast cancer patients as salvage therapy. Patients and Methods: In this phase II study we evaluated the clinical efficacy and tolerability of low dose, oral Methotrexate (MTX) and Cyclophosphamide (CTX) in patients with metastatic breast cancer. Between January 2004 and December 2005, 42 patients received MTX 2.5 mg bid on day 1 and 2 each week and CTX 50 mg/day administered continuously. Results: Forty two patients were evaluable. The overall clinical benefit was 31% complete response, partial response and stable disease (CR+PR+SD ³24 weeks), while the overall response rate was 16.7% (none of the patients attained CR). Toxicity was generally mild. The most common non hematological toxicity was elevation in transaminases level, it was reported in 40.4% of patients and was reversible, while mild grade 1 or 2 neutropenia was the most common hematological toxicity, (28.5% of patients). Median time to response was 3±0.18 while progression free survival (PFS) among patients with clinical benefit was 10 months (95% CI 6.65-13.44). Conclusions: This phase II study shows that, the combination of continuously low dose MTX and CTX is an active minimally toxic and significantly cost effective regimen for the treatment of metastatic breast cancer patients.

  8. Investigation of the explosion hazards of hydrogen sulphide. (Phase II)

    International Nuclear Information System (INIS)

    Moen, I.O.

    1986-01-01

    The results of Phase II of an investigation directed towards quantifying the explosive hazards of hydrogen sulphide in air are described. This second and final phase is focussed on flame acceleration until detonation in obstacle environments simulating a heavy water plant. The results of previous experimental tests, both small and large scale, are compiled and summarized and the results of a series of flame acceleration tests are reported. These tests were performed in order to assess the potential for damaging explosions in simulated industrial environments with repeated obstacles. The experimented apparatus consisted of a channel 1.8 m x 1.8 m in cross-section and 15.5 m long. Two obstacle configurations were tested, corresponding to 500 mm or 220 mm diameter tubes mounted across the channel at regular intervals. Tests were performed with acetylene, propane and hydrogen sulphide fuels. The results of numerical simulation are also reported and compared with the observed results. Scaling predictions are also made. The key results are summarized in the main text, and detailed reports covering the various aspects are included in three annexes

  9. Investigation of the explosion hazards of hydrogen sulphide. Phase II

    International Nuclear Information System (INIS)

    Moen, I.O.

    1986-01-01

    The results of Phase II of an investigation directed towards quantifying the explosive hazards of hydrogen sulphide in air are described. This second and final phase is focussed on flame acceleration until detonation in obstacle environments simulating a heavy water plant. The results of previous experimental tests, both small and large scale, are compiled and summarized and the results of a series of flame acceleration tests are reported. These tests were performed in order to assess the potential for damaging explosions in simulated industrial environments with repeated obstacles. The experimented apparatus consisted of a channel 1.8 m x 1.8 m in cross-section and 15.5 m long. Two obstacle configurations were tested, corresponding to 500 mm or 220 mm diameter tubes mounted across the channel at regular intervals. Tests were performed with acetylene, propane and hydrogen sulphide fuels. The results of numerical simulation are also reported and compared with the observed results. Scaling predictions are also made. The key results are summarized in the main text, and detailed reports covering the various aspects are included in three annexes

  10. Rooftop PV system. Final technical progress report, Phase II

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-08-01

    Under this four-year PV:BONUS Program, ECD and United Solar are developing and demonstrating two new lightweight flexible building integrated Photovoltaic (BIPV) modules specifically designed as exact replacements for conventional asphalt shingles and standing seam metal roofing. These modules can be economically and aesthetically integrated into new residential and commercial buildings, and address the even larger roofing replacement market. The modules are designed to be installed by roofing contractors without special training which minimizes the installation and balance of system costs. The modules will be fabricated from high-efficiency, multiple-junction a-Si alloy solar cells developed by ECD and United Solar. Under the Phase I Program, which ended in March 1994, we developed two different concept designs for rooftop PV modules: (1) the United Solar overlapping (asphalt shingle replacement) shingle-type modules and (2) the ECD metal roof-type modules. We also developed a plan for fabricating, testing and demonstrating these modules. Candidate demonstration sites for our rooftop PV modules were identified and preliminary engineering designs for these demonstrations were developed; a marketing study plan was also developed. The major objectives of the Phase II Program, which started in June 1994 was (1) to develop, test, and qualify these new rooftop modules; (2) to develop mechanical and electrical engineering specifications for the demonstration projects; and (3) to develop a marketing/commercialization plan.

  11. Alternate Reductant Cold Cap Evaluation Furnace Phase II Testing

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, F. C. [Savannah River Site (SRS), Aiken, SC (United States). Savannah River National Lab. (SRNL); Stone, M. E. [Savannah River Site (SRS), Aiken, SC (United States). Savannah River National Lab. (SRNL); Miller, D. H. [Savannah River Site (SRS), Aiken, SC (United States). Savannah River National Lab. (SRNL)

    2014-09-03

    Savannah River Remediation (SRR) conducted a Systems Engineering Evaluation (SEE) to determine the optimum alternate reductant flowsheet for the Defense Waste Processing Facility (DWPF). Specifically, two proposed flowsheets (nitric–formic–glycolic and nitric–formic–sugar) were evaluated based upon results from preliminary testing. Comparison of the two flowsheets among evaluation criteria indicated a preference towards the nitric–formic–glycolic flowsheet. Further research and development of this flowsheet eliminated the formic acid, and as a result, the nitric–glycolic flowsheet was recommended for further testing. Based on the development of a roadmap for the nitric–glycolic acid flowsheet, Waste Solidification Engineering (WS-E) issued a Technical Task Request (TTR) to address flammability issues that may impact the implementation of this flowsheet. Melter testing was requested in order to define the DWPF flammability envelope for the nitric-glycolic acid flowsheet. The Savannah River National Laboratory (SRNL) Cold Cap Evaluation Furnace (CEF), a 1/12th scale DWPF melter, was selected by the SRR Alternate Reductant project team as the melter platform for this testing. The overall scope was divided into the following sub-tasks as discussed in the Task Technical and Quality Assurance Plan (TTQAP): Phase I - A nitric–formic acid flowsheet melter test (unbubbled) to baseline the CEF cold cap and vapor space data to the benchmark melter flammability models; Phase II - A nitric–glycolic acid flowsheet melter test (unbubbled and bubbled) to: Define new cold cap reactions and global kinetic parameters in support of the melter flammability model development; Quantify off-gas surging potential of the feed; Characterize off-gas condensate for complete organic and inorganic carbon species. After charging the CEF with cullet from Phase I CEF testing, the melter was slurry-fed with glycolic flowsheet based SB6-Frit 418 melter feed at 36% waste

  12. MHD seed recovery and regeneration, Phase II. Final report

    Energy Technology Data Exchange (ETDEWEB)

    1994-10-01

    This final report summarizes the work performed by the Space and Technology Division of the TRW Space and Electronics Group for the U.S. Department of Energy, Pittsburgh Energy Technology Center for the Econoseed process. This process involves the economical recovery and regeneration of potassium seed used in the MHD channel. The contract period of performance extended from 1987 through 1994 and was divided into two phases. The Phase II test results are the subject of this Final Report. However, the Phase I test results are presented in summary form in Section 2.3 of this Final Report. The Econoseed process involves the treatment of the potassium sulfate in spent MHD seed with an aqueous calcium formate solution in a continuously stirred reactor system to solubilize, as potassium formate, the potassium content of the seed and to precipitate and recover the sulfate as calcium sulfate. The slurry product from this reaction is centrifuged to separate the calcium sulfate and insoluble seed constituents from the potassium formate solution. The dilute solids-free potassium formate solution is then concentrated in an evaporator. The concentrated potassium formate product is a liquid which can be recycled as a spray into the MHD channel. Calcium formate is the seed regenerant used in the Econoseed process. Since calcium formate is produced in the United States in relatively small quantities, a new route to the continuous production of large quantities of calcium formate needed to support an MHD power industry was investigated. This route involves the reaction of carbon monoxide gas with lime solids in an aqueous medium.

  13. Phased Retrofits in Existing Homes in Florida Phase II: Shallow Plus Retrofits

    Energy Technology Data Exchange (ETDEWEB)

    Sutherland, K. [Building America Partnership for Improved Residential Construction, Cocoa, FL (United States); Parker, D. [Building America Partnership for Improved Residential Construction, Cocoa, FL (United States); Martin, E. [Building America Partnership for Improved Residential Construction, Cocoa, FL (United States); Chasar, D. [Building America Partnership for Improved Residential Construction, Cocoa, FL (United States); Amos, B. [Building America Partnership for Improved Residential Construction, Cocoa, FL (United States)

    2016-02-03

    The BAPIRC team and Florida Power and Light (FPL) electric utility pursued a pilot phased energy-efficiency retrofit program in Florida by creating detailed data on the energy and economic performance of two levels of retrofit - simple and deep. For this Phased Deep Retrofit (PDR) project, a total of 56 homes spread across the utility partner's territory in east central Florida, southeast Florida, and southwest Florida were instrumented between August 2012 and January 2013, and received simple pass-through retrofit measures during the period of March 2013 - June 2013. Ten of these homes received a deeper package of retrofits during August 2013 - December 2013. A full account of Phase I of this project, including detailed home details and characterization, is found in Parker et al, 2015 (currently in draft). Phase II of this project, which is the focus of this report, applied the following additional retrofit measures to select homes that received a shallow retrofit in Phase I: a) Supplemental mini-split heat pump (MSHP) (6 homes); b) Ducted and space coupled Heat Pump Water Heater (8 homes); c) Exterior insulation finish system (EIFS) (1 homes); d) Window retrofit (3 homes); e) Smart thermostat (21 homes: 19 NESTs; 2 Lyrics); f) Heat pump clothes dryer (8 homes); g) Variable speed pool pump (5 homes).

  14. Multifunctional Metal/Polymer Composite Fiber for Space Applications, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In this Small Business Innovation Research Phase II Program, Syscom Technology, Inc. will implement an integrated processing scheme to fabricate a conductive...

  15. Spiral CT during pharmacoangiography with angiotensin II in patients with pancreatic disease. Technique and diagnostic efficacy

    Energy Technology Data Exchange (ETDEWEB)

    Kuroda, C.; Mihara, N.; Hosomi, N.; Inoue, E.; Fujita, M. [Osaka Medical Center for Cancer and Cardiovascular Diseases (Japan). Dept. of Diagnostic Radiology; Ohigashi, H.; Ishikawa, O. [Osaka Medical Center for Cancer and Cardiovascular Diseases (Japan). Dept. of Surgery; Nakaizumi, A. [Osaka Medical Center for Cancer and Cardiovascular Deseases (Japan). Dept. of Internal Medicine; Ishiguro, S. [Osaka Medical Center for Cancer and Cardiovascular Diseases (Japan). Dept. of Pathology

    1998-03-01

    Purpose: To compare the diagnostic efficacy of pancreatic pharmacoangiographic CT using angiotensin II with conventional angiographic CT. Material and Methods: Eighteen patients with space-occupying pancreatic disease were examined in this study. Pharmacoangiographic CT was performed with a 1-3-{mu}/6-ml solution of angiotensin II injected through a catheter into the celiac artery during spiral CT. Results: In 17 of the 18 (94%) patients, the area of pancreatic parenchymal enhancement was the same or larger at pharmacoangiographic CT than at conventional angiographic CT. The attenuation value of the pancreatic parenchyma was significantly increased at pharmacoangiographic CT (p=0.0010). Although the attenuation value of tumors was also increased on images obtained after the injection of angiotensin II, the tumor-to-pancreas contrast was significantly greater at pharmacoangiographic CT (p=0.0479). The mean differences in attenuation between tumor and pancreas at angiographic CT with and without angiotensin II were respectively 182 HU and 115 HU. Conclusion: Pharmacoangiographic CT with angiotensin II proved superior to conventional angiographic CT in the diagnosis of pancreatic disease. We therefore recommend it as a supplementary technique at the angiographic examination of patients with suspected pancreatic tumor. (orig.).

  16. Mercury Phase II Study - Mercury Behavior in Salt Processing Flowsheet

    International Nuclear Information System (INIS)

    Jain, V.; Shah, H.; Wilmarth, W. R.

    2016-01-01

    Mercury (Hg) in the Savannah River Site Liquid Waste System (LWS) originated from decades of canyon processing where it was used as a catalyst for dissolving the aluminum cladding of reactor fuel. Approximately 60 metric tons of mercury is currently present throughout the LWS. Mercury has long been a consideration in the LWS, from both hazard and processing perspectives. In February 2015, a Mercury Program Team was established at the request of the Department of Energy to develop a comprehensive action plan for long-term management and removal of mercury. Evaluation was focused in two Phases. Phase I activities assessed the Liquid Waste inventory and chemical processing behavior using a system-by-system review methodology, and determined the speciation of the different mercury forms (Hg+, Hg++, elemental Hg, organomercury, and soluble versus insoluble mercury) within the LWS. Phase II activities are building on the Phase I activities, and results of the LWS flowsheet evaluations will be summarized in three reports: Mercury Behavior in the Salt Processing Flowsheet (i.e. this report); Mercury Behavior in the Defense Waste Processing Facility (DWPF) Flowsheet; and Mercury behavior in the Tank Farm Flowsheet (Evaporator Operations). The evaluation of the mercury behavior in the salt processing flowsheet indicates, inter alia, the following: (1) In the assembled Salt Batches 7, 8 and 9 in Tank 21, the total mercury is mostly soluble with methylmercury (MHg) contributing over 50% of the total mercury. Based on the analyses of samples from 2H Evaporator feed and drop tanks (Tanks 38/43), the source of MHg in Salt Batches 7, 8 and 9 can be attributed to the 2H evaporator concentrate used in assembling the salt batches. The 2H Evaporator is used to evaporate DWPF recycle water. (2) Comparison of data between Tank 21/49, Salt Solution Feed Tank (SSFT), Decontaminated Salt Solution Hold Tank (DSSHT), and Tank 50 samples suggests that the total mercury as well as speciated

  17. Space Qualified Non-Destructive Evaluation and Structural Health Monitoring Technology, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Encouraged by Phase I accomplishments, the proposed Phase II program will significantly mature and align the development of a Space Qualified Non-Destructive...

  18. Lightweight Thermally Stable Multi-Meter Aperture Submillimeter Reflectors, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The objective of the Phase II effort will be an affordable demonstrated full-scale design for a thermally stable multi-meter submillimeter reflector. The Phase I...

  19. Reconfigurable L-band Radar Transceiver using Digital Signal Synthesis, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This Phase II proposal, builds upon the extensive research and digital radar design that has been successfully completed during the Phase I contract. Key innovations...

  20. MULTIFUNCTIONAL, SELF-HEALING HYBRIDSIL MATERIALS FOR EVA SPACE SUIT PRESSURE GARMENT SYSTEMS, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — A Phase II SBIR transition of NanoSonic's high flex HybridSil space suit bladder and glove materials will provide a pivotal funding bridge toward Phase III...

  1. The role of technology in reducing health care costs. Phase II and phase III.

    Energy Technology Data Exchange (ETDEWEB)

    Cilke, John F.; Parks, Raymond C.; Funkhouser, Donald Ray; Tebo, Michael A.; Murphy, Martin D.; Hightower, Marion Michael; Gallagher, Linda K.; Craft, Richard Layne, II; Garcia, Rudy John

    2004-04-01

    In Phase I of this project, reported in SAND97-1922, Sandia National Laboratories applied a systems approach to identifying innovative biomedical technologies with the potential to reduce U.S. health care delivery costs while maintaining care quality. The effort provided roadmaps for the development and integration of technology to meet perceived care delivery requirements and an economic analysis model for development of care pathway costs for two conditions: coronary artery disease (CAD) and benign prostatic hypertrophy (BPH). Phases II and III of this project, which are presented in this report, were directed at detailing the parameters of telemedicine that influence care delivery costs and quality. These results were used to identify and field test the communication, interoperability, and security capabilities needed for cost-effective, secure, and reliable health care via telemedicine.

  2. An Overview of 2014 SBIR Phase I and Phase II Materials Structures for Extreme Environments

    Science.gov (United States)

    Nguyen, Hung D.; Steele, Gynelle C.; Morris, Jessica R.

    2015-01-01

    NASA's Small Business Innovation Research (SBIR) program focuses on technological innovation by investing in development of innovative concepts and technologies to help NASA mission directorates address critical research needs for Agency programs. This report highlights nine of the innovative SBIR 2014 Phase I and Phase II projects that emphasize one of NASA Glenn Research Center's six core competencies-Materials and Structures for Extreme Environments. The technologies cover a wide spectrum of applications such as high temperature environmental barrier coating systems, deployable space structures, solid oxide fuel cells, and self-lubricating hard coatings for extreme temperatures. Each featured technology describes an innovation, technical objective, and highlights NASA commercial and industrial applications. This report provides an opportunity for NASA engineers, researchers, and program managers to learn how NASA SBIR technologies could help their programs and projects, and lead to collaborations and partnerships between the small SBIR companies and NASA that would benefit both.

  3. X-ray diffraction study of phase transitions in iron(II) trisnioximate hexadecylboronate clathrochelate complex

    International Nuclear Information System (INIS)

    Vorontsov, I.I.; Antipin, M.Yu.; Dubovik, I.I.; Papkov, V.S.; Potekhin, K.A.; Voloshin, Ya.Z.; Stash, A.I.; Belsky, V.K.

    2001-01-01

    Crystals of the iron(II) nioximate hexadecylboronate clathrochelate complex-FeNx 3 (BHd ) 2 [tris(μ-1,2-cyclohexanedionedioximato-O:O ' )di-n-hexadecyldiborato(2-) - N,'''N''',N''',N''',N''',N ' ]iron(II) - are investigated by differential scanning calorimetry and X-ray diffraction. Two structural phase transitions are revealed at T cr1 = 290(3) K and T cr2 = 190(3) K. The crystal structures of phases I, II, and III are determined by X-ray diffraction analysis at 303, 243, and 153 K, respectively. It is demonstrated that the I ↔ II phase transition is due to a change in the system of translations, and the II ↔ III phase transition is accompanied only by a jumpwise change in the unit cell parameters. The possible mechanisms of phase transitions are discussed in terms of geometry and molecular packing of FeNx 3 (BHd) 2 in all three phases

  4. Background rejection of n+ surface events in GERDA Phase II

    Science.gov (United States)

    Lehnert, Björn

    2016-05-01

    The GERDA experiment searches for neutrinoless double beta (0vββ) decay in 76Ge using an array of high purity germanium (HPGe) detectors immersed in liquid argon (LAr). Phase II of the experiment uses 30 new broad energy germanium (BEGe) detectors with superior pulse shape discrimination capabilities compared to the previously used semi-coaxial detector design. By far the largest background component for BEGe detectors in GERDA are n+-surface events from 42K β decays which are intrinsic in LAr. The β particles with up to 3.5 MeV can traverse the 0.5 to 0.9 mm thick electrode and deposit energy within the region of interest for the 0vββ decay. However, those events have particular pulse shape features allowing for a strong discrimination. The understanding and simulation of this background, showing a reduction by up to a factor 145 with pulse shape discrimination alone, is presented in this work.

  5. The Phase II ATLAS Pixel Upgrade: The Inner Tracker (ITk)

    CERN Document Server

    Flick, Tobias; The ATLAS collaboration

    2016-01-01

    The entire tracking system of the ATLAS experiment will be replaced during the LHC Phase II shutdown (foreseen to take place around 2025) by an all-silicon detector called the ITk (Inner Tracker). The pixel detector will comprise the five innermost layers, and will be instrumented with new sensor and readout electronics technologies to improve the tracking performance and cope with the HL-LHC environment, which will be severe in terms of occupancy and radiation. The total surface area of silicon in the new pixel system could measure up to 14 m^2, depending on the final layout choice, which is expected to take place in early 2017. Four layout options are being investigated at the moment, two with forward coverage to eta < 3.2 and two to eta < 4. For each coverage option, a layout with long barrel staves and a layout with novel inclined support structures in the barrel-endcap overlap region are considered. All potential layouts include modules mounted on ring-shaped supports in the endcap regions. Support...

  6. Micromegas R&D for ATLAS MUON PHASE II Upgrade

    CERN Document Server

    Farina, Edoardo Maria; The ATLAS collaboration

    2017-01-01

    In the framework of the ATLAS Phase II Upgrade, a proposal to extend the detector acceptance of the muon system to high η has been put forward (namely up to | η| ~ 4). Extension of the muon coverage has been demonstrated to enhance physics performance. The proposed location for the new detector is in between the end-cap calorimeter cryostat and the JD shielding; in this region there is no magnetic field applied, the aim of the new detector is therefore to only tag muons without performing any momentum measurement. The new η tagger should cope with extremely high particle rate, that has been calculated, by means of simulations, to be 9 MHz at R = 25 cm and 0.4 MHz at R = 60 cm for μ = 200, where μ stands for the number of pp collisions per bunch crossing. The required spatial resolution at the inner edge of the detector has been estimated in few hundreds micrometres. One of the most promising candidate technology for the new detector is the MicroMegaS one, which has already been adopted for the NSW upgrad...

  7. Validation of KENOREST with LWR-PROTEUS phase II samples

    Energy Technology Data Exchange (ETDEWEB)

    Wagner, M.; Kilger, R.; Pautz, A.; Zwermann, W. [GRS, Garching (Germany); Grimm, P.; Vasiliev, A.; Ferroukhi, H. [Paul Scherrer Institut, Villigen (Switzerland)

    2012-11-01

    In order to broaden the validation basis of the reactivity and nuclide inventory code KENOREST two samples of the LWR-PROTEUS phase II program have been calculated and compared to the experimental results. In general most nuclides are reproduced very well and agree within about ten percent with the experiment. Some already known problems, the overprediction of metallic fission products and the underprediction of the higher curium isotopes, have been confirmed. One of the largest uncertainties in the calculation was the burnup of the samples due to differences between a core simulation of the fuel vendor and the burnup determined from the measured values of the burnup indicator Nd-148. Two different models taking into account the environment for a peripheral fuel rod have been studied. The more detailed model included the three direct neighbor fuel assemblies depleted along with the fuel rod of interest. The influence on the results has been found to be very small. Compared to the uncertainties from the burnup, this effect can be considered negligible. The reason for the low influence was basically that the spectrum did not get considerably harder with increasing burnup beyond about 20GWd/tHM. Since the sample reached burnups far beyond that value, an effect could not be seen. In the near future an update of the used libraries is planned and it will be very interesting to study the effect on the results, especially for Curium. (orig.)

  8. Characterization of ToxCast Phase II compounds disruption of ...

    Science.gov (United States)

    The development of multi-well microelectrode array (mwMEA) systems has increased in vitro screening throughput making them an effective method to screen and prioritize large sets of compounds for potential neurotoxicity. In the present experiments, a multiplexed approach was used to determine compound effects on both neural function and cell health in primary cortical networks grown on mwMEA plates following exposure to ~1100 compounds from EPA’s Phase II ToxCast libraries. On DIV 13, baseline activity (40 min) was recorded prior to exposure to each compound at 40 µM. DMSO and the GABAA antagonist bicuculline (BIC) were included as controls on each mwMEA plate. Changes in spontaneous network activity (mean firing rate; MFR) and cell viability (lactate dehydrogenase; LDH and CellTiter Blue; CTB) were assessed within the same well following compound exposure. Activity calls (“hits”) were established using the 90th and 20th percentiles of the compound-induced change in MFR (medians of triplicates) across all tested compounds; compounds above (top 10% of compounds increasing MFR), and below (bottom 20% of compounds decreasing MFR) these thresholds, respectively were considered hits. MFR was altered beyond one of these thresholds by 322 compounds. Four compound categories accounted for 66% of the hits, including: insecticides (e.g. abamectin, lindane, prallethrin), pharmaceuticals (e.g. haloperidol, reserpine), fungicides (e.g. hexaconazole, fenamidone), and h

  9. Postirradiation examination of BEATRIX-II, Phase 1

    International Nuclear Information System (INIS)

    Slagle, O.D.; Hobbs, F.D.; Baldwin, D.L.; Hollenberg, G.W.; Takahashi, T.; Noda, K.; Verrall, R.A.

    1993-09-01

    BEATRIX-II is an in situ tritium recovery experiment that was designed to characterize the behavior of lithium ceramics irradiated to high burnup in a fast neutron flux. Postirradiation examination was carried out on the Phase 1 vented canisters: one containing a Li 2 O ring capable of temperature changes and the other a Li 2 O solid specimen with a center temperature of 1,000 degrees C. The tritium inventory of the ring specimen at 650 degrees C was determined to be in the range from 0.2--0.6 wppm while for the solid specimen the inventory varied from 1.4 wppm at the surface to 0.06 wppm at the inner surface. Downstream transport of the Li 2 O by the sweep gas was determined to be insignificant from analyses of acid rinses of selected canister surfaces. Densification and restructuring of the solid specimen during irradiation resulted in the development of a central annulus. Ceramography was used to characterize the columnar grain structure and the mechanisms involved in its evolution

  10. Horonobe Underground Research Laboratory project. Synthesis of phase II (construction phase) investigations to a depth of 350 m

    International Nuclear Information System (INIS)

    Sato, Toshinori; Sasamoto, Hiroshi; Ishii, Eiichi; Matsuoka, Toshiyuki; Hayano, Akira; Miyakawa, Kazuya; Fujita, Tomoo; Tanai, Kenji; Nakayama, Masashi; Takeda, Masaki; Yokota, Hideharu; Aoyagi, Kazuhei; Ohno, Hirokazu; Shigeta, Naotaka; Hanamuro, Takahiro; Ito, Hiroaki

    2017-03-01

    The Horonobe Underground Research Laboratory (URL) Project is being pursued by the Japan Atomic Energy Agency (JAEA) to enhance the reliability of relevant disposal technologies through investigations of the deep geological environment within the host sedimentary formations at Horonobe, northern Hokkaido. The project consists of two major research areas, 'Geoscientific Research' and 'R and D on Geological Disposal', and proceeds in three overlapping phases, 'Phase I: Surface-based investigation', 'Phase II: Construction' and 'Phase III: Operation', over a period of 20 years. This report summarizes the results of the Phase II investigations carried out from April 2005 to June 2014 to a depth of 350 m. Integration of work from different disciplines into a 'geosynthesis' ensures that the Phase II goals have been successfully achieved and identifies key issues that need to be addressed in the Phase II investigations. Efforts are made to summarize as many lessons learnt from the Phase II investigations and other technical achievements as possible to form a 'knowledge base' that will reinforce the technical basis for both implementation and the formulation of safety regulations. (author)

  11. A steerable/distance enhanced penetrometer delivery system: Phase II. Topical report

    International Nuclear Information System (INIS)

    Amini, A.; Shenhar, J.; Lum, K.D.

    1996-05-01

    This report summarizes the phase II work on the Position Location Device (POLO) for penetrometers. Phase II was carried out to generate an integrated design of a full-scale steerable/distance enhanced penetrometer delivery system. Steering provides for the controlled and directional use of the penetrometer, while vibratory thrusting can provide greater penetration ability

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

    Energy Technology Data Exchange (ETDEWEB)

    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

  13. Two randomised phase II trials of subcutaneous interleukin-2 and histamine dihydrochloride in patients with metastatic renal cell carcinoma

    DEFF Research Database (Denmark)

    Donskov, F; Middleton, M; Fode, K

    2005-01-01

    Histamine inhibits formation and release of phagocyte-derived reactive oxygen species, and thereby protects natural killer and T cells against oxidative damage. Thus, the addition of histamine may potentially improve the efficacy of interleukin-2 (IL-2). Two randomised phase II trials of IL-2...... per week for 3 weeks followed by 2 weeks rest. Histamine dihydrochloride was added twice daily, 1.0 mg s.c., concomitantly with IL-2. A maximum of four cycles were given. The Danish study showed a statistically significant 1-year survival benefit (76 vs 47%, P = 0.03), a trend towards benefit in both...

  14. Phase II study of Gleevec® plus hydroxyurea (HU) in adults with progressive or recurrent meningioma

    OpenAIRE

    Reardon, David A.; Norden, Andrew D.; Desjardins, Annick; Vredenburgh, James J.; Herndon, James E.; Coan, April; Sampson, John H.; Gururangan, Sridharan; Peters, Katherine B.; McLendon, Roger E.; Norfleet, Julie A.; Lipp, Eric S.; Drappatz, Jan; Wen, Patrick Y.; Friedman, Henry S.

    2011-01-01

    We prospectively evaluated the efficacy and safety of imatinib plus hydroxyurea in patients with progressive/recurrent meningioma. A total of 21 patients with progressive/recurrent meningioma were enrolled in this dual center, single-arm, phase II trial. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 400 mg/day for patients not on CYP3A enzyme inducing anti-epileptic drugs (EIAEDs) and at 500 mg twice a day for patients on EIAEDs. The primary endpoint wa...

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

    Science.gov (United States)

    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

  16. Phase I/II trial of vorinostat combined with temozolomide and radiation therapy for newly diagnosed glioblastoma: results of Alliance N0874/ABTC 02.

    Science.gov (United States)

    Galanis, Evanthia; Anderson, S Keith; Miller, C Ryan; Sarkaria, Jann N; Jaeckle, Kurt; Buckner, Jan C; Ligon, Keith L; Ballman, Karla V; Moore, Dennis F; Nebozhyn, Michael; Loboda, Andrey; Schiff, David; Ahluwalia, Manmeet Singh; Lee, Eudocia Q; Gerstner, Elizabeth R; Lesser, Glenn J; Prados, Michael; Grossman, Stuart A; Cerhan, Jane; Giannini, Caterina; Wen, Patrick Y

    2018-03-27

    Vorinostat, a histone deacetylase (HDAC) inhibitor, has shown radiosensitizing properties in preclinical studies. This open-label, single-arm trial evaluated the maximum tolerated dose (MTD; phase I) and efficacy (phase II) of vorinostat combined with standard chemoradiation in newly diagnosed glioblastoma. Patients received oral vorinostat (300 or 400 mg/day) on days 1-5 weekly during temozolomide chemoradiation. Following a 4- to 6-week rest, patients received up to 12 cycles of standard adjuvant temozolomide and vorinostat (400 mg/day) on days 1-7 and 15-21 of each 28-day cycle. Association between vorinostat response signatures and progression-free survival (PFS) and overall survival (OS) was assessed based on RNA sequencing of baseline tumor tissue. Phase I and phase II enrolled 15 and 107 patients, respectively. The combination therapy MTD was vorinostat 300 mg/day and temozolomide 75 mg/m2/day. Dose-limiting toxicities were grade 4 neutropenia and thrombocytopenia and grade 3 aspartate aminotransferase elevation, hyperglycemia, fatigue, and wound dehiscence. The primary efficacy endpoint in the phase II cohort, OS rate at 15 months, was 55.1% (median OS 16.1 mo), and consequently, the study did not meet its efficacy objective. Most common treatment-related grade 3/4 toxicities in the phase II component were lymphopenia (32.7%), thrombocytopenia (28.0%), and neutropenia (21.5%). RNA expression profiling of baseline tumors (N = 76) demonstrated that vorinostat resistance (sig-79) and sensitivity (sig-139) signatures had a reverse and positive association with OS/PFS, respectively. Vorinostat combined with standard chemoradiation had acceptable tolerability in newly diagnosed glioblastoma. Although the primary efficacy endpoint was not met, vorinostat sensitivity and resistance signatures could facilitate patient selection in future trials.

  17. Solid phase selective separation and preconcentration of Cu(II) by Cu(II)-imprinted polymethacrylic microbeads.

    Science.gov (United States)

    Dakova, Ivanka; Karadjova, Irina; Ivanov, Ivo; Georgieva, Ventsislava; Evtimova, Bisera; Georgiev, George

    2007-02-12

    Ion-imprinted polymer (IIP) particles are prepared by copolymerization of methacrylic acid as monomer, trimethylolpropane trimethacrylate as crosslinking agent and 2,2'-azo-bis-isobutyronitrile as initiator in the presence of Cu(II), a Cu(II)-4-(2-pyridylazo)resorcinol (Cu(II)-PAR) complex, and PAR only. A batch procedure is used for the determination of the characteristics of the Cu(II) solid phase extraction from the IIP produced. The results obtained show that the Cu(II)-PAR IIP has the greatest adsorption capacity (37.4 micromol g(-1) of dry copolymer) among the IIPs investigated. The optimal pH value for the quantitative preconcentration is 7, and full desorption is achieved by 1 M HNO(3). The selectivity coefficients (S(Cu/Me)) for Me=Ni(II), Co(II) are 45.0 and 38.5, respectively. It is established that Cu(II)-PAR IIPs can be used repeatedly without a considerable adsorption capacity loss. The determination of Cu(II) ions in seawater shows that the interfering matrix does not influence the preconcentration and selectivity values of the Cu(II)-PAR IIPs. The detection and quantification limits are 0.001 micromol L(-1) (3sigma) and 0.003 micromol L(-1) (6sigma), respectively.

  18. Rituximab in relapsing Graves' disease, a phase II study

    NARCIS (Netherlands)

    Heemstra, Karen A.; Toes, Rene E.; Sepers, Jan; Pereira, Alberto M.; Corssmit, Eleonora P.; Huizinga, Tom W. J.; Romijn, Johannes A.; Smit, Johannes W.

    2008-01-01

    Conventional therapies for Graves' disease, consisting of medical therapy or radioiodine are unsatisfactory, because of limited efficacy and adverse events. Interventions aimed at the underlying autoimmune pathogenesis of Graves' disease may be worthwhile to explore. We therefore performed a

  19. Clinical efficacy of terlipressin in treatment of type II hepatorenal syndrome

    Directory of Open Access Journals (Sweden)

    DING Xiaohong

    2015-05-01

    Full Text Available ObjectiveTo investigate the clinical efficacy of domestic terlipressin in the treatment of type II hepatorenal syndrome (HRS-II. MethodsA total of 25 HRS-II patients admitted to our hospital from November 2011 to June 2014 were recruited into the treatment group, and 28 HRS-II patients treated with dopamine before 2011 were recruited into the control group. Patients in the treatment group were randomly divided into two subgroups: one subgroup (n=12 was given terlipressin once every 8 h, and the other subgroup (n=13 was given terlipressin once every 12 h. Both groups received albumin (Alb infusion to expand the blood volume before treatment with terlipressin or dopamine, and the course of treatment was 7 days. The improvement in clinical symptoms, levels of blood urea nitrogen (BUN, serum creatinine and electrolytes, urine volume, changes in liver function, and ascites disappearance in the two groups before and after treatment were compared. Comparison of categorical data between the two groups was made by χ2 test, and comparison of continuous data was made by t test. ResultsPatients in the control group showed no obvious symptom relief, but those in the treatment group had varying degrees of improvement in clinical symptoms. Neither group had significant changes in liver function and serum sodium level after treatment. The treatment group had significantly more patients whose ascites volume had decreased from large to medium than the control group (χ2=5.705, P<0.05. There was a slight but not significant decrease in the levels of BUN and serum creatinine in the control group after treatment with dopamine (all P>0.05, whereas the urine volume showed significant difference after the treatment (t=15.534, P<0.01. The treatment group showed significant differences in the levels of BUN and serum creatinine and urine volume after terlipressin treatment (t=11.535, 9.941, and 19.685, respectively; all P<0.01, and significant differences in

  20. Physical Improvements in Exciter/Igniter Units, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The proposed Phase 2 project consists of the physical integration of our Phase 1 small, compact exciter with a "flight like" igniter or spark plug capable of...

  1. Microgrid Design, Development and Demonstration - Final Report for Phase I and Phase II

    Energy Technology Data Exchange (ETDEWEB)

    Bose, Sumit [GE Global Research Center, Niskayuna, NY (United States); Krok, Michael [GE Global Research Center, Niskayuna, NY (United States)

    2011-02-08

    This document constitutes GE’s final report for the Microgrid Design, Development and Demonstration program for DOE’s Office of Electricity Delivery and Energy Reliability, Award DE-FC02-05CH11349. It contains the final report for Phase I in Appendix I, and the results the work performed in Phase II. The program goal was to develop and demonstrate a Microgrid Energy Management (MEM) framework for a broad set of Microgrid applications that provides unified controls, protection, and energy management. This project contributed to the achievement of the U.S. Department of Energy’s Renewable and Distributed Systems Integration Program goals by developing a fully automated power delivery microgrid network that: - Reduces carbon emissions and emissions of other air pollutants through increased use of optimally dispatched renewable energy, - Increases asset use through integration of distributed systems, - Enhances reliability, security, and resiliency from microgrid applications in critical infrastructure protection, constrained areas of the electric grid, etc. - Improves system efficiency with on-site, distributed generation and improved economic efficiency through demand-side management.

  2. Solid-phase extraction of Mn(II), Co(II), Ni(II), Cu(II), Cd(II) and Pb(II) ions from environmental samples by flame atomic absorption spectrometry (FAAS)

    Energy Technology Data Exchange (ETDEWEB)

    Duran, Celal [Department of Chemistry, Faculty of Art and Science, Karadeniz Technical University, 61080 Trabzon (Turkey); Gundogdu, Ali [Department of Chemistry, Faculty of Art and Science, Karadeniz Technical University, 61080 Trabzon (Turkey); Bulut, Volkan Numan [Department of Chemistry, Giresun Faculty of Art and Science, Karadeniz Technical University, 28049 Giresun (Turkey); Soylak, Mustafa [Department of Chemistry, Faculty of Art and Science, Erciyes University, 38039 Kayseri (Turkey)]. E-mail: soylak@erciyes.edu.tr; Elci, Latif [Department of Chemistry, Faculty of Art and Science, Pamukkale University, 20020 Denizli (Turkey); Sentuerk, Hasan Basri [Department of Chemistry, Faculty of Art and Science, Karadeniz Technical University, 61080 Trabzon (Turkey); Tuefekci, Mehmet [Department of Chemistry, Faculty of Art and Science, Karadeniz Technical University, 61080 Trabzon (Turkey)

    2007-07-19

    A new method using a column packed with Amberlite XAD-2010 resin as a solid-phase extractant has been developed for the multi-element preconcentration of Mn(II), Co(II), Ni(II), Cu(II), Cd(II), and Pb(II) ions based on their complex formation with the sodium diethyldithiocarbamate (Na-DDTC) prior to flame atomic absorption spectrometric (FAAS) determinations. Metal complexes sorbed on the resin were eluted by 1 mol L{sup -1} HNO{sub 3} in acetone. Effects of the analytical conditions over the preconcentration yields of the metal ions, such as pH, quantity of Na-DDTC, eluent type, sample volume and flow rate, foreign ions etc. have been investigated. The limits of detection (LOD) of the analytes were found in the range 0.08-0.26 {mu}g L{sup -1}. The method was validated by analyzing three certified reference materials. The method has been applied for the determination of trace elements in some environmental samples.

  3. High Transparent Metal Oxide / Polyimide Antistatic Coatings, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Through this Phase I program, Agiltron has successfully produced an innovative transparent conductive nanocomposite paint that holds the promise of meeting space...

  4. Fiber Optic Temperature Sensors for Thermal Protection Systems, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In Phase 1, Intelligent Fiber Optic Systems Corporation (IFOS), in collaboration with North Carolina State University, successfully demonstrated a Fiber Bragg...

  5. Multicenter phase II study of sequential radioembolization-sorafenib therapy for inoperable hepatocellular carcinoma.

    Directory of Open Access Journals (Sweden)

    Pierce K H Chow

    Full Text Available The safety and tolerability of sequential radioembolization-sorafenib therapy is unknown. An open-label, single arm, investigator-initiated Phase II study (NCT0071279 was conducted at four Asia-Pacific centers to evaluate the safety and efficacy of sequential radioembolization-sorafenib in patients with hepatocellular carcinoma (HCC not amenable to curative therapies.Sorafenib (400 mg twice-daily was initiated 14 days post-radioembolization with yttrium-90 (90Y resin microspheres given as a single procedure. The primary endpoints were safety and tolerability and best overall response rate (ORR using RECIST v1.0.Secondary endpoints included: disease control rate (complete [CR] plus partial responses [PR] and stable disease [SD] and overall survival (OS.Twenty-nine patients with Barcelona Clinic Liver Cancer (BCLC stage B (38% or C (62% HCC received a median of 3.0 GBq (interquartile range, 1.0 90Y-microspheres followed by sorafenib (median dose/day, 600.0 mg; median duration, 4.1 months. Twenty eight patients experienced ≥1 toxicity; 15 (52% grade ≥3. Best ORR was 25%, including 2 (7% CR and 5 (18% PR, and 15 (54% SD. Disease control was 100% and 65% in BCLC stage B and C, respectively. Two patients (7% had sufficient response to enable radical therapy. Median survivals for BCLC stage B and C were 20.3 and 8.6 months, respectively.This study shows the potential efficacy and manageable toxicity of sequential radioembolization-sorafenib.ClinicalTrials.gov NCT00712790.

  6. Biomarker-Based Phase II Trial of Savolitinib in Patients With Advanced Papillary Renal Cell Cancer.

    Science.gov (United States)

    Choueiri, Toni K; Plimack, Elizabeth; Arkenau, Hendrik-Tobias; Jonasch, Eric; Heng, Daniel Y C; Powles, Thomas; Frigault, Melanie M; Clark, Edwin A; Handzel, Amir A; Gardner, Humphrey; Morgan, Shethah; Albiges, Laurence; Pal, Sumanta Kumar

    2017-09-10

    Purpose Patients with advanced papillary renal cell carcinoma (PRCC) have limited therapeutic options. PRCC may involve activation of the MET pathway, for example, through gene amplification or mutations. Savolitinib (AZD6094, HMPL-504, volitinib) is a highly selective MET tyrosine kinase inhibitor. We report results of a single-arm, multicenter, phase II study evaluating the safety and efficacy of savolitinib in patients with PRCC according to MET status. Patients and Methods Patients with histologically confirmed locally advanced or metastatic PRCC were enrolled and received savolitinib 600 mg orally once daily. MET-driven PRCC was defined as any of the following: chromosome 7 copy gain, focal MET or HGF gene amplification, or MET kinase domain mutations. Efficacy was assessed according to MET status. Safety, toxicity, and patient-reported health-related quality-of-life outcomes were assessed in all patients. Results Of 109 patients treated, PRCC was MET driven in 44 (40%) and MET independent in 46 (42%); MET status was unknown in 19 (17%). MET-driven PRCC was strongly associated with response; there were eight confirmed partial responders with MET-driven disease (18%), but none with MET-independent disease ( P = .002). Median progression-free survival for patients with MET-driven and MET-independent PRCC was 6.2 months (95% CI, 4.1 to 7.0 months) and 1.4 months (95% CI, 1.4 to 2.7 months), respectively (hazard ratio, 0.33; 95% CI, 0.20 to 0.52; log-rank P < .001). The most frequent adverse events associated with savolitinib were nausea, fatigue, vomiting, and peripheral edema. Conclusion These data show activity and tolerability of savolitinib in the subgroup of patients with MET-driven PRCC. Furthermore, molecular characterization of MET status was more predictive of response to savolitinib than a classification based on pathology. These findings justify investigating savolitinib in MET-driven PRCC.

  7. Phase I-II study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer

    International Nuclear Information System (INIS)

    Huijts, Charlotte M; Santegoets, Saskia J; Eertwegh, Alfons J van den; Pijpers, Laura S; Haanen, John B; Gruijl, Tanja D de; Verheul, Henk M; Vliet, Hans J van der

    2011-01-01

    For patients with metastatic renal cell cancer (mRCC) who progressed on vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor therapy, the orally administered mammalian target of rapamycin (mTOR) inhibitor everolimus has been shown to prolong progression free survival. Intriguingly, inhibition of mTOR also promotes expansion of immunosuppressive regulatory T cells (Tregs) that can inhibit anti-tumor immune responses in a clinically relevant way in various tumor types including RCC. This study intends to investigate whether the antitumor efficacy of everolimus can be increased by preventing the detrimental everolimus induced expansion of Tregs using a metronomic schedule of cyclophosphamide. This phase I-II trial is a national multi-center study of different doses and schedules of low-dose oral cyclophosphamide in combination with a fixed dose of everolimus in patients with mRCC not amenable to or progressive after a VEGF-receptor tyrosine kinase inhibitor containing treatment regimen. In the phase I part of the study the optimal Treg-depleting dose and schedule of metronomic oral cyclophosphamide when given in combination with everolimus will be determined. In the phase II part of the study we will evaluate whether the percentage of patients progression free at 4 months of everolimus treatment can be increased from 50% to 70% by adding metronomic cyclophosphamide (in the dose and schedule determined in the phase I part). In addition to efficacy, we will perform extensive immune monitoring with a focus on the number, phenotype and function of Tregs, evaluate the safety and feasibility of the combination of everolimus and cyclophosphamide, perform monitoring of selected angiogenesis parameters and analyze everolimus and cyclophosphamide drug levels. This phase I-II study is designed to determine whether metronomic cyclophosphamide can be used to counter the mTOR inhibitor everolimus induced Treg expansion in patients with metastatic renal cell

  8. Phase I-II study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer

    Directory of Open Access Journals (Sweden)

    Huijts Charlotte M

    2011-11-01

    Full Text Available Abstract Background For patients with metastatic renal cell cancer (mRCC who progressed on vascular endothelial growth factor (VEGF receptor tyrosine kinase inhibitor therapy, the orally administered mammalian target of rapamycin (mTOR inhibitor everolimus has been shown to prolong progression free survival. Intriguingly, inhibition of mTOR also promotes expansion of immunosuppressive regulatory T cells (Tregs that can inhibit anti-tumor immune responses in a clinically relevant way in various tumor types including RCC. This study intends to investigate whether the antitumor efficacy of everolimus can be increased by preventing the detrimental everolimus induced expansion of Tregs using a metronomic schedule of cyclophosphamide. Methods/design This phase I-II trial is a national multi-center study of different doses and schedules of low-dose oral cyclophosphamide in combination with a fixed dose of everolimus in patients with mRCC not amenable to or progressive after a VEGF-receptor tyrosine kinase inhibitor containing treatment regimen. In the phase I part of the study the optimal Treg-depleting dose and schedule of metronomic oral cyclophosphamide when given in combination with everolimus will be determined. In the phase II part of the study we will evaluate whether the percentage of patients progression free at 4 months of everolimus treatment can be increased from 50% to 70% by adding metronomic cyclophosphamide (in the dose and schedule determined in the phase I part. In addition to efficacy, we will perform extensive immune monitoring with a focus on the number, phenotype and function of Tregs, evaluate the safety and feasibility of the combination of everolimus and cyclophosphamide, perform monitoring of selected angiogenesis parameters and analyze everolimus and cyclophosphamide drug levels. Discussion This phase I-II study is designed to determine whether metronomic cyclophosphamide can be used to counter the mTOR inhibitor everolimus

  9. SmartPark Technology Demonstration Project, Phase II: Final Report

    Science.gov (United States)

    2018-05-01

    The purpose of FMCSA's SmartPark project was to determine the feasibility of a technology for providing truck parking space availability information in real time to truckers on the road. SmartPark consisted of two phases. Phase I was a field operatio...

  10. The active phasing experiment: Part II. Design and developments

    Science.gov (United States)

    Gonte, F.; Yaitskova, N.; Derie, F.; Araujo, C.; Brast, R.; Delabre, B.; Dierickx, P.; Dupuy, C.; Frank, C.; Guisard, S.; Karban, R.; Noethe, L.; Sedghi, B.; Surdej, I.; Wilhelm, R.; Reyes, M.; Esposito, S.; Langlois, M.

    2006-06-01

    The purpose of the Active Phasing Experiment, designed under the lead of ESO, is to validate wavefront control concepts for ELT class telescopes. This instrument includes an Active Segmented Mirror, located in a pupil image. It will be mounted at a Nasmyth focus of one of the Unit Telescopes of the ESO VLT. APE contains four different types of phasing sensors, which are developed by Istituto Nazionale di Astrofisica in Arcetri, Instituto Astrofisica Canarias, Laboratoire d'Astrophysique de Marseille and ESO. These phasing sensors can be compared simultaneously under identical optical and environmental conditions. All sensors receive telecentric F/15 beams with identical optical quality and intensity. Each phasing sensor can measure segmentation errors of the active segmented mirror and correct them in closed loop. The phasing process is supervised by an Internal Metrology system developed by FOGALE Nanotech and capable of measuring piston steps with an accuracy of a few nanometers. The Active Phasing Experiment is equipped with a turbulence generator to simulate atmospheric seeing between 0.45 and 0.85 arcsec in the laboratory. In addition, the Active Phasing Experiment is designed to control simultaneously with the phasing corrections the guiding and the active optics of one of the VLT Unit Telescopes. This activity is supported by the European Community (Framework Programme 6, ELT Design Study, contract No 011863).

  11. Phase II Study of Temozolomide and Thalidomide in Patients with Unresectable or Metastatic Leiomyosarcoma

    Directory of Open Access Journals (Sweden)

    Michelle S. Boyar

    2008-01-01

    Full Text Available We assessed the efficacy of combined temozolomide and thalidomide in patients with unresectable or metastatic leiomyosarcoma in a phase II single-institution trial. Twenty-four patients were enrolled. Temozolomide (150 mg/m2/day for 7 days every other week was administered with concomitant thalidomide (200 mg/day, and continued until unacceptable toxicity or disease progression. There were no complete responses and two (10% partial responses. Five patients (24% had stable disease for at least six months. Fourteen patients (67% progressed after a median of two-month treatment. The median overall survival (twenty-two assessable patients was 9.5 months [95% CI 7–28 months]. There were no treatment-related deaths or CTC grade 4 toxicities. Thirteen patients were dose-reduced or discontinued thalidomide due to toxicity. In conclusion, this combination of temozolomide and thalidomide provided disease stabilization in a subset of patients with advanced leiomyosarcoma. We hypothesize that temozolomide is the active agent in this regimen, and should be further studied.

  12. Phase II trial of SOM230 (pasireotide LAR) in patients with unresectable hepatocellular carcinoma.

    Science.gov (United States)

    Feun, Lynn G; Wangpaichitr, Medhi; Li, Ying-Ying; Kwon, Deukwoo; Richman, Stephen P; Hosein, Peter J; Savaraj, Niramol

    2018-01-01

    A phase II trial of pasireotide was performed to assess its efficacy and safety in advanced or metastatic hepatocellular carcinoma (HCC). Patients with advanced HCC and Child-Pugh score ≤7 received pasireotide LAR 60 mg intramuscularly every 28 days. Primary endpoint was disease control rate. Secondary endpoints were time to tumor progression, response rate, treatment-related adverse events, and overall survival. Serum insulin growth factor-1 was measured before and after pasireotide. Twenty patients were treated and evaluable. Eighteen patients (90%) had prior therapy; 16 patients (80%) had multiple therapies. Median age was 65, 75% had Barcelona Clinic Liver Cancer stage C, and 55% had metastatic disease. The main toxicity was hyperglycemia. Rare adverse effects included reversible grade 4 elevation in alanina transaminase/aspartate transaminase in one patient. The best response was stable disease in 9 patients (45%). Median time to tumor progression for the 20 patients was 3 months, and median survival was 9 months. Pasireotide had limited clinical benefit as second-line or third-line treatment in patients with advanced or metastatic HCC. Low baseline insulin growth factor-1 level may be indicative when SOM230 treatment may be ineffective, and decreasing levels after treatment may be indicative of disease control.

  13. F/H Area Effluent Treatment Facility. Phase II. CAC basic data

    International Nuclear Information System (INIS)

    Collins, W.W.; O'Leary, C.D.

    1984-01-01

    Project objectives and requirements are listed for both Phase I and II. Schedule is listed with startup targeted for 1989. Storage facilities will be provided for both chemical and radioactive effluents. 8 figs., 19 tabs

  14. Advanced 3D Human Simulation Components with Thermal/Haptic Feedback and Tissue Deformation, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In integrating the following three significant components for its research/research and development (R/R&D) effort, the power of this candidate Phase II project...

  15. Dynamic Flight Simulation Utilizing High Fidelity CFD-Based Nonlinear Reduced Order Model, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The Nonlinear Dynamic Flight Simulation (NL-DFS) system will be developed in the Phase II project by combining the classical nonlinear rigid-body flight dynamics...

  16. Finite Element Models for Electron Beam Freeform Fabrication Process, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This Small Business Innovation Research Phase II proposal offers to develop a comprehensive computer simulation methodology based on the finite element method for...

  17. An Instrument for Inspecting Aspheric Optical Surfaces and Components, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This is a Phase II SBIR proposal to develop an extremely versatile optical inspection tool for aspheric optical components and optics that are not easily inspected...

  18. A High Energy and High Efficiency Spectral Shaping Single Frequency Fiber Laser, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This SBIR phase II project proposes a single frequency high energy fiber laser system for coherent Lidar systems for remote sensing. Current state-of-art...

  19. Expanded Operational Temperature Range for Space Rated Li-Ion Batteries, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Quallion's Phase II proposal calls for expanding the nominal operation range of its space rated lithium ion cells, while maintaining their long life capabilities. To...

  20. Lunar Navigator - A Miniature, Fully Autonomous, Lunar Navigation, Surveyor, and Range Finder System, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Microcosm will use existing hardware and software from related programs to create a prototype Lunar Navigation Sensor (LNS) early in Phase II, such that most of the...

  1. Scaled Model Technology for Flight Research of General Aviation Aircraft, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Our proposed future Phase II activities are aimed at developing a scientifically based "tool box" for flight research using scaled models. These tools will be of...

  2. Solid State Transmitters for Water Vapor and Ozone DIAL Systems, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The focus of this Select Phase II program is to build and deliver laser components both for airborne water vapor and ozone DIAL systems. Specifically, Fibertek...

  3. Magnetic sensor for nondestructive evaluation of deteriorated prestressing strand : phase II.

    Science.gov (United States)

    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...

  4. Large Format LW Type-II SLS FPAs for Space Applications, Phase I

    Data.gov (United States)

    National Aeronautics and Space Administration — This Phase I SBIR proposes to develop high performance (low dark current, high quantum efficiency, and low NEdT) infrared epitaxy materials based on Type II Strained...

  5. Extreme Environment Damage Index and Accumulation Model for CMC Laminate Fatigue Life Prediction, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Materials Research & Design (MR&D) is proposing in the SBIR Phase II an effort to develop a tool for predicting the fatigue life of C/SiC composite...

  6. Monolithic, High-Speed Fiber-Optic Switching Array for Lidar, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This NASA SBIR Phase II effort will develop a 1 x 10 prototype non-mechanical fiber optic switch for use with high power lasers. The proposed optical device is a...

  7. Trimodality therapy for malignant pleural mesothelioma: Results from an EORTC phase II multicentre trial

    NARCIS (Netherlands)

    P.E.Y. van Schil (Paul); P. Baas (Paul); R.M. Gaafar (Rabab); A.W.P.M. Maat (Alex); F. Van De Pol (Francien); B. Hasane (B.); H.M. Klomp (Houke); A.M. Abdelrahman (A.); J. Welche (J.); J.P. van Meerbeeck (Jan)

    2010-01-01

    textabstractThe European Organisation for Research and Treatment of Cancer (EORTC; protocol 08031) phase II trial investigated the feasibility of trimodality therapy consisting of induction chemotherapy followed by extrapleural pneumonectomy and post-operative radiotherapy in patients with malignant

  8. Lightweight Design of an HTS Coil for the VASIMR Experiment, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In this Phase II SBIR contract Tai-Yang Research Company of Tennessee proposes to design, fabricate, and test an ultra-lightweight High Temperature Superconducting...

  9. Coordinated Control of Multi-Agent Systems in Rapidly Varying Environments, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The main objective of this Phase II STTR project is to develop advanced control algorithms that enable multiple autonomous agents to perform complex tasks in rapidly...

  10. Deployable Engine Air-Brake for Drag Management Applications, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — ATA Engineering, Inc., (ATA) proposes a Phase II SBIR program to demonstrate an innovative engine air-brake (EAB) technology that uses a deployable swirl vane...

  11. OrFPGA: An Empirical Performance Tuning Tool for FPGA Designs, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In this Phase II STTR project, RNET and its subcontractors are proposing to fully develop an empirical performance optimization tool called OrFPGA that efficiently...

  12. Advanced Nongray Radiation Module in the LOCI Framework for Combustion CFD, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Radiative heat fluxes are important in the design of launch vehicles for Project Constellation. In this Phase II STTR, CFDRC and its partner Mississippi State...

  13. Generic FMS Platform for Evaluation of Autonomous Trajectory-Based Operation Concepts, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The objective of the Phase II work is to develop a generic, advanced Flight Management System (FMS) for the evaluation of autonomous 4D-trajectory based operations...

  14. Battery Separator Membrane Having a Selectable Thermal Shut-Down Temperature, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This Small Business Innovation Research Phase II proposal to NASA requests $596,750.96 support for Policell Technologies, Inc. to develop a series of separator...

  15. Efficient Integration, Validation and Troubleshooting in Multimodal Distributed Diagnostic Schemes, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In general, development and validation of diagnostic models for complex safety critical systems are time and cost intensive jobs. The proposed Phase-II effort will...

  16. Polymer-Reinforced, Nonbrittle, Lightweight Cryogenic Insulation for Reduced Life-Cycle Costs, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This Phase II SBIR project focuses to continue developing cryogenic insulation foams that are flexible, deforming under compression. InnoSense LLC (ISL) demonstrated...

  17. Development of Diamond Vacuum Differential Amplifier for Harsh Environment Power Electronics, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In this proposed Phase II, Scientic and Vanderbilt University will develop a novel vacuum field emission differential amplifier (VFEDA) using low electron affinity...

  18. Fiber Coupled Pulse Shaper for Sub-Nanosecond Pulse Lidar, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This Small Business Innovation Research Phase II effort will develop an all-diode laser and fiber optic based, single frequency, sub-nanosecond pulsed laser source...

  19. Functional design criteria for project W-252, phase II liquid effluent treatment and disposal. Revision 2

    International Nuclear Information System (INIS)

    Hatch, C.E.

    1995-05-01

    This document is the Functional Design Criteria for Project W-252. Project W-252 provides the scope to provide BAT/AKART (best available technology...) to 200 Liquid Effluent Phase II streams (B-Plant). This revision (Rev. 2) incorporates a major descoping of the project. The descoping was done to reflect a combination of budget cutting measures allowed by a less stringent regulatory posture toward the Phase II streams

  20. Viet Nam Economic Research Network (VERN) - Phase II | CRDI ...

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

    VERN I (101273) constituted the first network for young economic researchers in Viet Nam, where previously there had been no modality for cooperation or peer review. Guided by the philosophy of "understanding and managing globalization" that underpinned the earlier project, VERN II proposes to expand the network, ...

  1. First results of GERDA Phase II and consistency with background models

    Science.gov (United States)

    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.

  2. Semantic Summarization for Context Aware Manipulation of Data, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — NASA's exploration and scientific missions will produce terabytes of information. As NASA enters a new phase of space exploration, managing large amounts of...

  3. Thermo-Acoustic Convertor for Space Power, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In Phase Sunpower looked at Thermoacoustic Stirling Heat Engines (TASHEs). These ranged from a TASHE which was sized for the heat from a single General Purpose Heat...

  4. Sputter-Resistant Materials for Electric Propulsion, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This SBIR Phase 2 project shall develop sputter-resistant materials for use in electric propulsion test facilities and for plume shields on spacecraft using electric...

  5. Advanced Filtering Techniques Applied to Spaceflight, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — IST-Rolla developed two nonlinear filters for spacecraft orbit determination during the Phase I contract. The theta-D filter and the cost based filter, CBF, were...

  6. Propellant Flow Actuated Piezoelectric Rocket Engine Igniter, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Under a Phase 1 effort, IES successfully developed and demonstrated a spark ignition concept where propellant flow drives a very simple fluid mechanical oscillator...

  7. Surface Modification of Exfoliated Graphite Nano-Reinforcements, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Phase I results showed that two surface treatments, oxidative plasma and reactive finishes, are effective means of modifying the surface chemistry of exfoliated...

  8. SMALL MAIN-BELT ASTEROID SPECTROSCOPIC SURVEY, PHASE II

    Data.gov (United States)

    National Aeronautics and Space Administration — This data set contains visible-wavelength (0.435-0.925 micron) spectra for 1341 main-belt asteroids observed during the second phase of the Small Main-belt Asteroid...

  9. Scalable Lunar Surface Networks and Adaptive Orbit Access, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Based on our proposed innovations and accomplished work in Phase I, we will focus on developing the new MAC protocol and hybrid routing protocol for lunar surface...

  10. MOIDSS?- Mobile Online Intelligent Decision Support System, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — GRID has had a successfully completed Phase I 'Mobile Online Intelligent Decision Support System' (MOIDSS). The system developed into a total solution that supports...

  11. Passive Wireless SAW Humidity Sensors and System, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Phase I demonstrated the technical feasibility of creating surface acoustic wave (SAW) based humidity sensors that respond rapidly (under 0.5 second) and reversibly...

  12. Identification and Reduction of Turbomachinery Noise, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Communities near airports are often exposed to high noise levels due to low flying aircraft in the takeoff and landing phases of flight. Propulsion source noise is...

  13. High-Fidelity Aerodynamic Design with Transition Prediction, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — To enhance aerodynamic design capabilities, Desktop Aeronautics proposes to significantly improve upon the integration (performed in Phase 1) of a new sweep/taper...

  14. Structural Integrity Inspection and Visualization System, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Based on the successful feasibility demonstration in Phase I, Physical Optics Corporation (POC) proposes to continue the development of a novel Structural Integrity...

  15. Distributed Rocket Engine Testing Health Monitoring System, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Leveraging the Phase I achievements of the Distributed Rocket Engine Testing Health Monitoring System (DiRETHMS) including its software toolsets and system building...

  16. Aerodynamic Efficiency Enhancements for Air Vehicles, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The need for aerodynamics-based efficiency enhancements for air vehicles is presented. The results of the Phase I investigation of concepts for morphing aircraft are...

  17. No-Oven, No-Autoclave, Composite Processing, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Cornerstone Research Group Inc. (CRG) proposes to continue the efforts from the 2010 NASA SBIR Phase I topic X5.03, "No-Oven, No-Autoclave (NONA) Composite...

  18. Modular Ultra-High Power Solar Array Architecture, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Deployable Space Systems (DSS) will focus the proposed Phase 2 SBIR program on the hardware-based development and TRL advance of a highly-modularized and...

  19. Laser Femto-Tesla Magnetic Gradiometer (LFMG), Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The LFMG instrument is used to make extremely high resolution scalar magnetic field and difference measurements at the Earthfs surface. The Phase 1 effort included...

  20. Open System of Agile Ground Stations, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The Phase I effort demonstrated, through actual development and tests with a spacecraft system, the technical and programmatic feasibility of developing, within the...

  1. Multipurpose Electric Potential Sensor for Spacecraft Applications, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The original goal of Phase I was to study the feasibility of developing an electric sensor that can be used for as many NASA sensing applications as possible. During...

  2. Heliopause Electrostatic Rapid Transit System (HERTS) (Phase II)

    Data.gov (United States)

    National Aeronautics and Space Administration — Our proposal builds upon our teams technical findings in Phase 1 - that an E-Sail propelled spacecraft can travel 100 AU in less than 10 years or to the Heliopause...

  3. Transportation Life Cycle Assessment (LCA) Synthesis, Phase II

    Science.gov (United States)

    2018-04-24

    The Transportation Life Cycle Assessment (LCA) Synthesis includes an LCA Learning Module Series, case studies, and analytics on the use of the modules. The module series is a set of narrated slideshows on topics related to environmental LCA. Phase I ...

  4. Digital Conically Scanned L-Band Radar, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The proposed effort seeks to develop a digitally steered polarimetric phased array L-Band radar utilizing a novel, high performance architecture leveraging recent...

  5. Outcome Mapping Virtual Learning Community - Phase II | IDRC ...

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

    The first phase of the project (103520) focused on developing the Outcome ... as distance learning) and strategically communicating Outcome Mapping to key ... an organization based in India with South Asian reach, to facilitate exchange ...

  6. Contact Stress Design Parameters for Titanium Bearings, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Air-Lock's Phase I effort tested the effects of ball induced contact stresses on Titanium bearing races. The contact stress design limit that would achieve a...

  7. Fiber Optic Shape Sensing for Tethered Marsupial Rovers, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Building upon the successful proof of concept work in Phase I, Luna Innovations Incorporated is proposing to design, build, and test a sensing tether for marsupial...

  8. Low Cost, Light Weight Materials for Mirrors, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — During the phase I program Northwestern and APS, Inc., have manufactured several different materials systems that are lighter than Beryllium and stiffer than...

  9. In-Process Monitoring of Additive Manufacturing, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In Phase I of this project MLPC, WSU, and AFIT were successfully able to identify several optical data features that are indicative of the quality of components...

  10. Fine Water Mist Fire Extinguisher for Spacecraft, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — This three phase SBIR project from ADA Technologies Inc. (ADA) builds upon the experience of ADA in development of fine water mist (FWM) fire suppression technology....

  11. High Performance Low Mass Nanowire Enabled Heatpipe, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Heat pipes are widely used for passive, two-phase electronics cooling. As advanced high power, high performance electronics in space based and terrestrial...

  12. Three-phase Bone Scintigraphy Can Predict the Analgesic Efficacy of Ketamine Therapy in CRPS.

    Science.gov (United States)

    Sorel, Marc; Beatrix, Jacques-Christian; Locko, Blanche; Armessen, Catherine; Domec, Anne-Marie; Lecompte, Otilia; Boucheneb, Sofiane; Harache, Benoit; Robert, Jacques; Lefaucheur, Jean-Pascal

    2018-03-13

    The efficacy of ketamine in relieving complex regional pain syndrome (CRPS) lacks predictive factors. The value of three-phase bone scintigraphy (TPBS) was assessed or this purpose. TPBS was performed in 105 patients with unilateral, focal CRPS of type 1 before 5 days of ketamine infusions. Tracer uptake was measured in the region of interest concerned by CRPS and the contralateral homologous region. For the three scintigraphic phases (vascular, tissular, and bone phases), an asymmetry ratio of fixation was calculated between the affected and the unaffected sides (VPr, TPr, and BPr). Ketamine efficacy was assessed on pain intensity scores. Ketamine-induced pain relief did not correlate with VPr, TPr, and BPr, but with the ratios of these ratios: BPr/TPr (r=0.32, P=0.009), BPr/VPr (r=0.34, P=0.005), and TPr/VPr (r=0.23, P=0.02). The optimum cut-off value for predicting the response to ketamine therapy was >1.125 for BPr/TPr, >1.075 for BPr/VPr, and >0.935 for TPr/VPr. The combination of increased values of BPr/TPr, BPr/VPr, and TPr/VPr was extremely significantly associated with ketamine therapy outcome. The relative hyperfixation of the radioactive tracer in the limb region concerned by CRPS in phases 2 and 3 versus phase 1 of TPBS correlated positively to the analgesic efficacy of ketamine. This study shows for the first time the potential predictive value of TPBS regarding ketamine therapy outcome. In addition, these results suggest that the analgesic action of ketamine is not restricted to "central" mechanisms, but may also involve "peripheral" mechanisms related to tissue inflammation and bone remodeling.

  13. Conversion of Phase II Unsteady Aerodynamics Experiment Data to Common Format; TOPICAL

    International Nuclear Information System (INIS)

    Hand, M. M.

    1999-01-01

    A vast amount of aerodynamic, structural, and turbine performance data were collected during three phases of the National Renewable Energy Laboratory's Unsteady Aerodynamics Experiment (UAE). To compare data from the three phases, a similar format of engineering unit data is required. The process of converting Phase II data from a previous engineering unit format to raw integer counts is discussed. The integer count files can then be input to the new post-processing software, MUNCH. The resulting Phase II engineering unit files are in a common format with current and future UAE engineering unit files. An additional objective for changing the file format was to convert the Phase II data from English units to SI units of measurement

  14. PBFA [Particle Beam Fusion Accelerator] II: The pulsed power characterization phase

    International Nuclear Information System (INIS)

    Martin, T.H.; Turman, B.N.; Goldstein, S.A.

    1987-01-01

    The Particle Beam Fusion Accelerator II, PBFA II, is now the largest pulsed power device in operation. This paper summarizes its first year and a half of operation for the Department of Energy (DOE) Inertial Confinement Fusion (ICF) program. Thirty-six separate modules provide 72 output pulses that combine to form a 100 TW output pulse at the accelerator center. PBFA II was successfully test fired for the first time on December 11, 1985. This test completed the construction phase (Phase 1) within the expected schedule and budget. The accelerator checkout phase then started (Phase 2). The first priority during checkout was to bring the Phase 1 subsystems into full operation. The accelerator was first tested to determine overall system performance. Next, subsystems that were not performing adequately were modified. The accelerator is now being used for ion diode studies. 32 refs

  15. Phase II Clinical Trial of Robotic Stereotactic Body Radiosurgery for Metastatic Gynecologic Malignancies

    International Nuclear Information System (INIS)

    Kunos, Charles A.; Brindle, James; Waggoner, Steven; Zanotti, Kristine; Resnick, Kimberly; Fusco, Nancy; Adams, Ramon; Debernardo, Robert

    2012-01-01

    Background: Recurrent gynecologic cancers are often difficult to manage without significant morbidity. We conducted a phase II study to assess the safety and the efficacy of ablative robotic stereotactic body radiosurgery (SBRT) in women with metastatic gynecologic cancers. Methods: A total of 50 patients with recurrent gynecologic cancer who had single or multiple (≤4) metastases underwent robotic-armed Cyberknife SBRT (24Gy/3 daily doses). Toxicities were graded prospectively by common toxicity criteria for adverse events (version 4.0). SBRT target responses were recorded following RECIST criteria (version 1.0). Rates of clinical benefit for SBRT and non-radiosurgical disease relapse were calculated. Disease-free and overall survivals were estimated by the Kaplan–Meier method and the Cox proportional hazards model was used to control for prognostic variables. Findings: SBRT was safely delivered, with 49 (98%) of 50 patients completing three prescribed fractions. The most frequent grade 2 or higher adverse events attributed to SBRT included fatigue (16%), nausea (8%), and diarrhea (4%). One (2%) grade four hyperbilirubinemia occurred. SBRT target response was 96% (48 of 50 patients). A 6-month clinical benefit was recorded in 34 [68% (95% CI, 53.2, 80.1)] patients. No SBRT targeted disease progressed. Non-radiosurgical disease relapse occurred in 31 (62%) patients. Median disease-free survival was 7.8 months (95% CI, 4.0, 11.6). Median overall survival was 20.2 months (95% CI, 10.9, 29.5). Interpretation: SBRT safely controlled metastatic gynecologic cancer targets. Given an observed high rate of non-radiosurgical disease relapse, a phase I trial assessing co-administration of SBRT and cytotoxic chemotherapy is underway. Funding: Case Comprehensive Cancer Center.

  16. Phase II clinical trial of robotic stereotactic body radiosurgery for metastatic gynecologic malignancies

    Directory of Open Access Journals (Sweden)

    Charles eKunos

    2012-12-01

    Full Text Available Background Recurrent gynecologic cancers are often difficult to manage without significant morbidity. We conducted a phase II study to assess the safety and the efficacy of ablative robotic stereotactic body radiosurgery (SBRT in women with metastatic gynecologic cancers. Methods A total of 50 patients with recurrent gynecologic cancer who had single or multiple (≤4 metastases underwent robotic-armed Cyberknife SBRT (24Gy/3 daily doses. Toxicities were graded prospectively by common toxicity criteria for adverse events (version 4.0. SBRT target responses were recorded following RECIST criteria (version 1.0. Rates of clinical benefit for SBRT and non-radiosurgical disease relapse were calculated. Disease-free and overall survivals were estimated by the Kaplan-Meier method and the Cox proportional hazards model was used to control for prognostic variables.Findings SBRT was safely delivered, with 49 (98% of 50 patients completing three prescribed fractions. The most frequent grade 2 or higher adverse events attributed to SBRT included fatigue (16%, nausea (8% and diarrhea (4%. One (2% grade 4 hyperbilirubinemia occurred. SBRT target response was 96% (48 of 50 patients. A 6-month clinical benefit was recorded in 34 (68% [95% CI, 53.2, 80.1] patients. No SBRT-targeted disease progressed. Non-radiosurgical disease relapse occurred in 31 (62% patients. Median disease-free survival was 7.8 months (95% CI, 4.0, 11.6. Median overall survival was 20.2 months (95% CI, 10.9, 29.5.Interpretation SBRT safely controlled metastatic gynecologic cancer targets. Given an observed high rate of non-radiosurgical disease relapse, a phase I trial assessing co-administration of SBRT and cytotoxic chemotherapy is underway.Funding Case Comprehensive Cancer Center

  17. Phase II Clinical Trial of Robotic Stereotactic Body Radiosurgery for Metastatic Gynecologic Malignancies

    Energy Technology Data Exchange (ETDEWEB)

    Kunos, Charles A.; Brindle, James [Department of Radiation Oncology, University Hospitals Case Medical Center and Case Western Reserve University, School of Medicine, Cleveland, OH (United States); Waggoner, Steven; Zanotti, Kristine; Resnick, Kimberly; Fusco, Nancy; Adams, Ramon; Debernardo, Robert, E-mail: charles.kunos@uhhospitals.org [Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University Hospitals Case Medical Center and Case Western Reserve University, School of Medicine, Cleveland, OH (United States)

    2012-12-05

    Background: Recurrent gynecologic cancers are often difficult to manage without significant morbidity. We conducted a phase II study to assess the safety and the efficacy of ablative robotic stereotactic body radiosurgery (SBRT) in women with metastatic gynecologic cancers. Methods: A total of 50 patients with recurrent gynecologic cancer who had single or multiple (≤4) metastases underwent robotic-armed Cyberknife SBRT (24Gy/3 daily doses). Toxicities were graded prospectively by common toxicity criteria for adverse events (version 4.0). SBRT target responses were recorded following RECIST criteria (version 1.0). Rates of clinical benefit for SBRT and non-radiosurgical disease relapse were calculated. Disease-free and overall survivals were estimated by the Kaplan–Meier method and the Cox proportional hazards model was used to control for prognostic variables. Findings: SBRT was safely delivered, with 49 (98%) of 50 patients completing three prescribed fractions. The most frequent grade 2 or higher adverse events attributed to SBRT included fatigue (16%), nausea (8%), and diarrhea (4%). One (2%) grade four hyperbilirubinemia occurred. SBRT target response was 96% (48 of 50 patients). A 6-month clinical benefit was recorded in 34 [68% (95% CI, 53.2, 80.1)] patients. No SBRT targeted disease progressed. Non-radiosurgical disease relapse occurred in 31 (62%) patients. Median disease-free survival was 7.8 months (95% CI, 4.0, 11.6). Median overall survival was 20.2 months (95% CI, 10.9, 29.5). Interpretation: SBRT safely controlled metastatic gynecologic cancer targets. Given an observed high rate of non-radiosurgical disease relapse, a phase I trial assessing co-administration of SBRT and cytotoxic chemotherapy is underway. Funding: Case Comprehensive Cancer Center.

  18. Donepezil improves gait performance in older adults with mild Alzheimer's disease: a phase II clinical trial.

    Science.gov (United States)

    Montero-Odasso, Manuel; Muir-Hunter, Susan W; Oteng-Amoako, Afua; Gopaul, Karen; Islam, Anam; Borrie, Michael; Wells, Jennie; Speechley, Mark

    2015-01-01

    Gait deficits are prevalent in people with dementia and increase their fall risk and future disability. Few treatments exist for gait impairment in Alzheimer's disease (AD) but preliminary studies have shown that cognitive enhancers may improve gait in this population. To determine the efficacy of donepezil, a cognitive enhancer that improves cholinergic activity, on gait in older adults newly diagnosed with AD. Phase II clinical trial in 43 seniors with mild AD who received donepezil. Participants had not previously received treatment with cognitive enhancers. Primary outcome variables were gait velocity (GV) and stride time variability (STV) under single and dual-task conditions measured using an electronic walkway. Secondary outcomes included attention and executive function. After four months of treatment, participants with mild AD improved their GV from 108.4 ± 18.6 to 113.3 ± 19.5 cm/s, p = 0.010; dual-task GV from 80.6 ± 23.0 to 85.3 ± 22.3 cm/s, p = 0.028. Changes in STV were in the expected direction although not statistically significant. Participants also showed improvements in Trail Making Tests A (p = 0.030), B (p = 0.001), and B-A (p = 0.042). Donepezil improved gait in participants with mild AD. The enhancement of dual-task gait suggests the positive changes achieved in executive function as a possible causal mechanism. This study yielded a clinically significant estimate of effect size; as well, the findings are relevant to the feasibility and ethics considerations for the design of a Phase III clinical trial.

  19. Grassmann phase space methods for fermions. II. Field theory

    Energy Technology Data Exchange (ETDEWEB)

    Dalton, B.J., E-mail: bdalton@swin.edu.au [Centre for Quantum and Optical Science, Swinburne University of Technology, Melbourne, Victoria 3122 (Australia); Jeffers, J. [Department of Physics, University of Strathclyde, Glasgow G4ONG (United Kingdom); Barnett, S.M. [School of Physics and Astronomy, University of Glasgow, Glasgow G12 8QQ (United Kingdom)

    2017-02-15

    In both quantum optics and cold atom physics, the behaviour of bosonic photons and atoms is often treated using phase space methods, where mode annihilation and creation operators are represented by c-number phase space variables, with the density operator equivalent to a distribution function of these variables. The anti-commutation rules for fermion annihilation, creation operators suggests the possibility of using anti-commuting Grassmann variables to represent these operators. However, in spite of the seminal work by Cahill and Glauber and a few applications, the use of Grassmann phase space methods in quantum-atom optics to treat fermionic systems is rather rare, though fermion coherent states using Grassmann variables are widely used in particle physics. This paper presents a phase space theory for fermion systems based on distribution functionals, which replace the density operator and involve Grassmann fields representing anti-commuting fermion field annihilation, creation operators. It is an extension of a previous phase space theory paper for fermions (Paper I) based on separate modes, in which the density operator is replaced by a distribution function depending on Grassmann phase space variables which represent the mode annihilation and creation operators. This further development of the theory is important for the situation when large numbers of fermions are involved, resulting in too many modes to treat separately. Here Grassmann fields, distribution functionals, functional Fokker–Planck equations and Ito stochastic field equations are involved. Typical applications to a trapped Fermi gas of interacting spin 1/2 fermionic atoms and to multi-component Fermi gases with non-zero range interactions are presented, showing that the Ito stochastic field equations are local in these cases. For the spin 1/2 case we also show how simple solutions can be obtained both for the untrapped case and for an optical lattice trapping potential.

  20. Grassmann phase space methods for fermions. II. Field theory

    International Nuclear Information System (INIS)

    Dalton, B.J.; Jeffers, J.; Barnett, S.M.

    2017-01-01

    In both quantum optics and cold atom physics, the behaviour of bosonic photons and atoms is often treated using phase space methods, where mode annihilation and creation operators are represented by c-number phase space variables, with the density operator equivalent to a distribution function of these variables. The anti-commutation rules for fermion annihilation, creation operators suggests the possibility of using anti-commuting Grassmann variables to represent these operators. However, in spite of the seminal work by Cahill and Glauber and a few applications, the use of Grassmann phase space methods in quantum-atom optics to treat fermionic systems is rather rare, though fermion coherent states using Grassmann variables are widely used in particle physics. This paper presents a phase space theory for fermion systems based on distribution functionals, which replace the density operator and involve Grassmann fields representing anti-commuting fermion field annihilation, creation operators. It is an extension of a previous phase space theory paper for fermions (Paper I) based on separate modes, in which the density operator is replaced by a distribution function depending on Grassmann phase space variables which represent the mode annihilation and creation operators. This further development of the theory is important for the situation when large numbers of fermions are involved, resulting in too many modes to treat separately. Here Grassmann fields, distribution functionals, functional Fokker–Planck equations and Ito stochastic field equations are involved. Typical applications to a trapped Fermi gas of interacting spin 1/2 fermionic atoms and to multi-component Fermi gases with non-zero range interactions are presented, showing that the Ito stochastic field equations are local in these cases. For the spin 1/2 case we also show how simple solutions can be obtained both for the untrapped case and for an optical lattice trapping potential.

  1. Forensic relevance of glucuronidation in phase-II-metabolism of alcohols and drugs.

    Science.gov (United States)

    Kaeferstein, Herbert

    2009-04-01

    Forensic toxicology means detecting toxic or pharmacologically active substances in body fluids and organs and the evaluation and judgement of the respective results. In the legal judgement, not only the taken in active drugs, but also their metabolites are to be included. Regarding metabolism one distinguishes phase-I- and phase-II-metabolism. In the phase-I-metabolism, active substances are converted by oxidation, reduction or hydrolysis, but influencing the polarity of more lipophilic substances often not decisively. The pharmacological activity is often preserved or even increased. In phase-II-metabolism a highly hydrophilic substance--mostly glucuronic acid--is coupled to the active substances or the respective phase-I-metabolites. This reaction step decisively increases hydrophilicity of lipophilic substances, thus enhancing renal elimination and often also abolishing pharmacologically and/or toxicologically effects. Nevertheless the interaction of different drugs and alcohols in glucuronidation and the glucuronides of phase-II-metabolism still do not play a substantial role in the forensic-toxicological analysis and interpretation of results so far. However, in vitro investigations since 1999 in our lab show that such interactions are not unlikely. For valid interpretation of complex cases in the future it may become necessary not only to quantify drugs and the phase-I-metabolites but also the phase-II-metabolites and discuss possible interactions in the metabolism.

  2. An Experimental Evaluation of Hyperactivity and Food Additives. 1977-Phase II.

    Science.gov (United States)

    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…

  3. Targeting radioimmunotherapy of hepatocellular carcinoma with iodine (131I) metuximab injection: Clinical Phase I/II trials

    International Nuclear Information System (INIS)

    Chen Zhinan; Mi Li; Xu Jing

    2006-01-01

    Purpose: HAb18G/CD147 is a hepatocellular carcinoma (HCC)-associated antigen. We developed iodine ( 131 I) metuximab injection (Licartin), a novel 131 I-labeled HAb18G/CD147-specific monoclonal antibody F(ab') 2 fragment, and evaluated its safety, pharmacokinetics, and clinical efficacy on HCC in Phase I/II trials. Methods and Materials: In a Phase I trial, 28 patients were randomly assigned to receive the injection in 9.25-, 18.5-, 27.75-, or 37-MBq/kg doses by hepatic artery infusion. In a multicenter Phase II trial, 106 patients received the injection (27.75 MBq/kg) on Day 1 of a 28-day cycle. Response rate and survival rate were the endpoints. Results: No life-threatening toxic effects were found. The safe dosage was 27.75 MBq/kg. The blood clearance fitted a biphasic model, and its half-life was 90.56-63.93 h. In the Phase II trial, the injection was found to be targeted and concentrated to tumor tissues. Of the 73 patients completing two cycles, 6 (8.22%) had a partial response, 14 (19.18%) minor response, and 43 (58.90%) stable disease. The 21-month survival rate was 44.54%. The survival rate of progression-free patients was significantly higher than that of patients with progressive disease after either one or two cycles (p 131 I) metuximab injection is safe and active for HCC patients

  4. Differential roles of phase I and phase II enzymes in 3,4-methylendioxymethamphetamine-induced cytotoxicity.

    NARCIS (Netherlands)

    Antolino Lobo, I.; Meulenbelt, J.; Nijmeijer, S.M.; Scherpenisse, P.; van den Berg, M.; van Duursen, M.B.M.

    2010-01-01

    Metabolism plays an important role in the toxic effects caused by 3,4-methylenedioxymethamphetamine (MDMA). Most research has focused on the involvement of CYP2D6 enzyme in MDMA bioactivation, and less is known about the contribution of other cytochrome P450 (P450) and phase II metabolism. In this

  5. China Public Budget Reform Program (CPBR) - Phase II | IDRC ...

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

    The Government of China has adopted a national reform program aimed at making budgeting more transparent and accountable through public involvement and enhanced oversight. Building on work carried out under Phase I (102965), the China Development Research Foundation (CDRF) will analyze China's current ...

  6. African Transitional Justice Research Network - Phase II | CRDI ...

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

    The African Transitional Justice Research Network (ATJRN) aims to strengthen the capacity of African researchers and civil society institutions to conduct effective human rights advocacy through the production of high-quality, locally based and targeted empirical research. Phase I of the project (102862) focused on creating ...

  7. Lebanese Palestinian Dialogue Committee (LPDC) - Phase II | IDRC ...

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

    During Phase I (100971), LPDC set up a website and commissioned papers from Lebanese and Palestinian researchers on such subjects as "non-Ids" - Palestinians with no official documents - and employment issues in Lebanon. LPDC was instrumental in coordinating the efforts of Lebanese stakeholders during the Nahr ...

  8. Public Report on Health (India) - Phase II | IDRC - International ...

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

    The Public Report on Health aims to draw federal and state attention to the health needs of ordinary people, so as to develop evidence-based solutions for meeting those needs. The Intensive Village Study carried out during the first phase of ... Outputs. Reports. Public report on health : final technical report. Download PDF ...

  9. African Transitional Justice Research Network - Phase II | IDRC ...

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

    The African Transitional Justice Research Network (ATJRN) aims to strengthen the capacity of African researchers and civil society institutions to conduct effective human rights advocacy through the production of high-quality, locally based and targeted empirical research. Phase I of the project (102862) focused on creating ...

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

    Science.gov (United States)

    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

  11. Technical Analysis of the Hydrogen Energy Station Concept, Phase I and Phase II

    Energy Technology Data Exchange (ETDEWEB)

    TIAX, LLC

    2005-05-04

    patterns would be most viable for an energy station, TIAX developed several criteria for selecting a representative set of technology configurations. TIAX applied these criteria to all possible technology configurations to determine an optimized set for further analysis, as shown in Table ES-1. This analysis also considered potential energy station operational scenarios and their impact upon hydrogen and power production. For example, an energy station with a 50-kWe reformer could generate enough hydrogen to serve up to 12 vehicles/day (at 5 kg/fill) or generate up to 1,200 kWh/day, as shown in Figure ES-1. Buildings that would be well suited for an energy station would utilize both the thermal and electrical output of the station. Optimizing the generation and utilization of thermal energy, hydrogen, and electricity requires a detailed look at the energy transfer within the energy station and the transfer between the station and nearby facilities. TIAX selected the Baseline configuration given in Table ES-1 for an initial analysis of the energy and mass transfer expected from an operating energy station. Phase II The purpose of this technical analysis was to analyze the development of a hydrogen-dispensing infrastructure for transportation applications through the installation of a 50-75 kW stationary fuel cell-based energy station at federal building sites. The various scenarios, costs, designs and impacts of such a station were quantified for a hypothetical cost-shared program that utilizes a natural gas reformer to provide hydrogen fuel for both the stack(s) and a limited number of fuel cell powered vehicles, with the possibility of using cogeneration to support the building heat load.

  12. De-Escalation Strategies in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer (BC): Final Analysis of the West German Study Group Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early BC HER2- and Hormone Receptor-Positive Phase II Randomized Trial-Efficacy, Safety, and Predictive Markers for 12 Weeks of Neoadjuvant Trastuzumab Emtansine With or Without Endocrine Therapy (ET) Versus Trastuzumab Plus ET.

    Science.gov (United States)

    Harbeck, Nadia; Gluz, Oleg; Christgen, Matthias; Kates, Ronald Ernest; Braun, Michael; Küemmel, Sherko; Schumacher, Claudia; Potenberg, Jochem; Kraemer, Stefan; Kleine-Tebbe, Anke; Augustin, Doris; Aktas, Bahriye; Forstbauer, Helmut; Tio, Joke; von Schumann, Raquel; Liedtke, Cornelia; Grischke, Eva-Maria; Schumacher, Johannes; Wuerstlein, Rachel; Kreipe, Hans Heinrich; Nitz, Ulrike Anneliese

    2017-09-10

    Purpose Human epidermal growth factor receptor 2 (HER2)-positive/hormone receptor (HR)-positive breast cancer is a distinct subgroup associated with lower chemotherapy sensitivity and slightly better outcome than HER2-positive/HR-negative disease. Little is known about the efficacy of the combination of endocrine therapy (ET) with trastuzumab or with the potent antibody-cytotoxic, anti-HER2 compound trastuzumab emtansine (T-DM1) with or without ET for this subgroup. The West German Study Group trial, ADAPT (Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer) compares pathologic complete response (pCR) rates of T-DM1 versus trastuzumab with ET in early HER2-positive/HR-positive breast cancer. Patients and Methods In this prospective, neoadjuvant, phase II trial, 375 patients with early breast cancer with HER2-positive and HR-positive status (n = 463 screened) were randomly assigned to 12 weeks of T-DM1 with or without ET or to trastuzumab with ET. The primary end point was pCR (ypT0/is/ypN0). Early response was assessed in 3-week post-therapeutic core biopsies (proliferation decrease ≥ 30% Ki-67 or cellularity response). Secondary end points included safety and predictive impact of early response on pCR. Adjuvant therapy followed national standards. Results Baseline characteristics were well balanced among the arms. More than 90% of patients completed the therapy per protocol. pCR was observed in 41.0% of patients treated with T-DM1, 41.5% of patients treated with T-DM1 and ET, and 15.1% with trastuzumab and ET ( P < .001). Early responders (67% of patients with assessable response) achieved pCR in 35.7% compared with 19.8% in nonresponders (odds ratio, 2.2; 95% CI, 1.24 to 4.19). T-DM1 was associated with a significantly higher prevalence of grade 1 to 2 toxicities, especially thrombocytopenia, nausea, and elevation of liver enzymes. Overall toxicity was low; seventeen

  13. Phase I/II study of azacitidine and capecitabine/oxaliplatin (CAPOX) in refractory CIMP-high metastatic colorectal cancer: evaluation of circulating methylated vimentin.

    Science.gov (United States)

    Overman, Michael J; Morris, Van; Moinova, Helen; Manyam, Ganiraju; Ensor, Joe; Lee, Michael S; Eng, Cathy; Kee, Bryan; Fogelman, David; Shroff, Rachna T; LaFramboise, Thomas; Mazard, Thibault; Feng, Tian; Hamilton, Stanley; Broom, Bradley; Lutterbaugh, James; Issa, Jean-Pierre; Markowitz, Sanford D; Kopetz, Scott

    2016-10-11

    Hypermethylation of promoter CpG islands (CIMP) has been strongly implicated in chemotherapy resistance and is implicated in the pathogenesis of a subset of colorectal cancers (CRCs) termed CIMP-high. This phase I/II study in CRC (phase II portion restricted to CIMP-high CRC), treated fluoropyrimidine/oxaliplatin refractory patients with azacitidine (75 mg/m2/day subcutaneously D1-5) and CAPOX (capecitibine and oxaliplatin) every three weeks. Twenty-six patients (pts) were enrolled in this study: 15 pts (12 treated at MTD) in phase I and 11 pts in phase II. No dose limiting toxicities were observed. A total of 14 pts were CIMP-high. No responses were seen. CIMP-high status did not correlate with efficacy endpoints [stable disease (SD) or progression-free survival (PFS)] or baseline vimentin methylation level. Changes in vimentin methylation over time did not correlate with efficacy outcomes. Baseline methylated vimentin correlated with tumor volume (PCIMP-high pts, but no objective responses. Serum methylated vimentin may be associated with benefit from a regimen including a hypomethylation agent, although this study is not able to separate a potential prognostic or predictive role for the biomarker.

  14. Self-regulation following prostatectomy : Phase-specific self-efficacy beliefs in implementing pelvic-floor exercise

    OpenAIRE

    Burkert, Silke; Knoll, Nina; Scholz, Urte; Roigas, Jan; Gralla, Oliver

    2012-01-01

    Beliefs in one's ability to perform a task or behaviour successfully are described as self-efficacy beliefs (Bandura, 1977). Since individuals have to deal with differing demands during a behaviour-change process, they form phase-specific self-efficacy beliefs directed at these respective challenges. The present study, based on the Health Action Process Approach (Schwarzer, 2001), examines the theoretical differentiation, relative importance, and differential effects of four phase-specific se...

  15. Explaining European Emission Allowance Price Dynamics: Evidence from Phase II

    OpenAIRE

    Wilfried Rickels; Dennis Görlich; Gerrit Oberst

    2010-01-01

    In 2005, the European Emission Trading Scheme (EU-ETS) established a new commodity: the right to emit a ton of CO2 (EUA). Since its launch, the corresponding price has shown rather turbulent dynamics, including nervous reactions to policy announcements and a price collapse after a visible over-allocation in Phase I. As a consequence, the question whether fundamental factors (fossil fuel prices, economic activity, weather) affect the EUA price remained partially unresolved. Today, being halfwa...

  16. Efficacy of the organic-certified insecticide Diatect II against the boll weevil (Anthonomus grandis) in cotton.

    Science.gov (United States)

    Sappington, Thomas W

    2002-10-01

    The efficacy of the organic insecticide Diatect II against boll weevil (Anthonomus grandis Boheman) in cotton (Gossypium hirsutum L) in the Lower Rio Grande Valley of Texas were assessed in small-plot field trials and greenhouse cage tests using azinphos-methyl treatments as a standard for comparison. Plastic sheets were placed in the furrows of the treated plots to retrieve boll weevils which dropped from the plants after being killed by the insecticides. Samples of live weevils taken by a tractor-mounted vacuum sampler revealed a modest, but significant, reduction in boll weevil populations in Diatect II plots. However, samples of dead weevils indicated that this reduction was due to movement of weevils out of the plots rather than to mortality. This interpretation is supported by greenhouse cage studies, where mortality in Diatect II treated cages was no greater than that in untreated control cages. The effects of insecticide treatments in small plots can be confounded easily and quickly by interplot movement of target insects. Although the relative effects of various compounds can usually be assessed by sampling the populations in plots soon after treatment, the best measure of efficacy is obtained by directly sampling insects that have died in the plot. This parameter is insulated from the effects of interplot movement, unless the toxicant is slow to immobilize the target insect. Taken together, our results indicate little efficacy by Diatect II against boll weevil under our test conditions.

  17. Comparing two tetraalkylammonium ionic liquids. II. Phase transitions

    Energy Technology Data Exchange (ETDEWEB)

    Lima, Thamires A.; Paschoal, Vitor H.; Faria, Luiz F. O.; Ribeiro, Mauro C. C., E-mail: mccribei@iq.usp.br [Laboratório de Espectroscopia Molecular, Departamento de Química Fundamental, Instituto de Química, Universidade de São Paulo, CP 26077, CEP 05513-970 São Paulo, SP (Brazil); Ferreira, Fabio F.; Costa, Fanny N. [Centro de Ciências Naturais e Humanas, Universidade Federal do ABC, Santo André, SP (Brazil); Giles, Carlos [Depto. de Física da Matéria Condensada, Instituto de Física Gleb Wataghin, Universidade Estadual de Campinas, 13083-859 Campinas, SP (Brazil)

    2016-06-14

    Phase transitions of the ionic liquids n-butyl-trimethylammonium bis(trifluoromethanesulfonyl)imide, [N{sub 1114}][NTf{sub 2}], and methyl-tributylammonium bis(trifluoromethanesulfonyl)imide, [N{sub 1444}][NTf{sub 2}], were investigated by differential scanning calorimetry (DSC), X-ray diffraction (XRD) measurements, and Raman spectroscopy. XRD and Raman spectra were obtained as a function of temperature at atmospheric pressure, and also under high pressure at room temperature using a diamond anvil cell (DAC). [N{sub 1444}][NTf{sub 2}] experiences glass transition at low temperature, whereas [N{sub 1114}][NTf{sub 2}] crystallizes or not depending on the cooling rate. Both the ionic liquids exhibit glass transition under high pressure. XRD and low-frequency Raman spectra provide a consistent physical picture of structural ordering-disordering accompanying the thermal events of crystallization, glass transition, cold crystallization, pre-melting, and melting. Raman spectra in the high-frequency range of some specific cation and anion normal modes reveal conformational changes of the molecular structures along phase transitions.

  18. Dead layer and active volume determination for GERDA Phase II detectors

    Energy Technology Data Exchange (ETDEWEB)

    Lehnert, Bjoern [TU Dresden (Germany); Collaboration: GERDA-Collaboration

    2013-07-01

    The GERDA experiment investigates the neutrinoless double beta decay of {sup 76}Ge and is currently running Phase I of its physics program. Using the same isotope as the Heidelberg Moscow (HDM) experiment, GERDA aims to directly test the claim of observation by a subset of the HDM collaboration. For the update to Phase II of the experiment in 2013, the collaboration organized the production of 30 new Broad Energy Germanium (BEGe) type detectors from original 35 kg enriched material and tested their performance in the low background laboratory HADES in SCK.CEN, Belgium. With additional 20 kg of detectors, GERDA aims to probe the degenerated hierarchy scenario. One of the crucial detector parameters is the active volume (AV) fraction which directly enters into all physics analysis. This talk presents the methodology of dead layer and AV determination with different calibration sources such as {sup 241}Am, {sup 133}Ba, {sup 60}Co and {sup 228}Th and the results obtained for the new Phase II detectors. Furthermore, the AV fraction turned out to be the largest systematic uncertainty in the analysis of Phase I data which makes it imperative to reduce its uncertainty for Phase II. This talk addresses the major contributions to the AV uncertainty and gives an outlook for improvements in Phase II analysis.

  19. A multicenter phase II study of carboplatin in advanced ovarian carcinoma: final report.

    Science.gov (United States)

    Kjorstad, K; Harris, A; Bertelsen, K; Slevin, M; Schultz, H; Hellman, K; Janssens, N; Martin, A; Canetta, R

    1992-03-01

    A phase II trial of single-agent carboplatin in advanced ovarian cancer was performed by 19 institutions from 10 European countries. A total of 260 patients were treated, with a median age of 55 (range: 20-79) years. Karnofsky performance status was 80-100 in about two-thirds of the patients. Prior therapy consisted of surgery only in 31 patients, irradiation in 9, chemotherapy without cisplatin in 45, and with cisplatin in 175. Carboplatin was administered as second-line therapy in about one-half and as third-line or more in one additional third of the study population. Initial dose was 400 mg/m2 in 90, 360 mg/m2 in 152, and 320 mg/m2 or less in 18 patients. A total of 971 courses (mean 3.7, median 2, range: 1-13) of therapy were administered. A total of 16 complete and 46 partial responses were observed in 226 evaluable patients, for an objective response rate of 27%. Efficacy was greater in chemotherapy-untreated patients (51% vs. 23%, p = 0.002). In cisplatin-pretreated patients activity was significantly higher in non-refractory patients (26% vs. 4%, p = 0.015). Myelosuppression was the most significant side effect. However, low hematologic counts seldom translated into clinically significant complications. Patients with impaired baseline creatinine clearance and poor performance status were at higher risk of developing severe myelosuppression during the initial course of treatment. Non hematologic side effects were rare and mild, except for emesis. Carboplatin has a definite role in the treatment of ovarian cancer, but almost complete cross-resistance with the parent compound was observed clinically.

  20. Phase II trial of SOM230 (pasireotide LAR in patients with unresectable hepatocellular carcinoma

    Directory of Open Access Journals (Sweden)

    Feun LG

    2018-01-01

    Full Text Available Lynn G Feun,¹ Medhi Wangpaichitr,² Ying-Ying Li,¹ Deukwoo Kwon,³ Stephen P Richman,¹ Peter J Hosein,¹ Niramol Savaraj¹,² ¹Department of Medicine, Medical Oncology, Sylvester Comprehensive Cancer Center, University of Miami, ²Department of Surgery, Miami VA Healthcare System, Research Service, ³Biostatistics and Bioinformatics Core, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA Background: A phase II trial of pasireotide was performed to assess its efficacy and safety in advanced or metastatic hepatocellular carcinoma (HCC.Patients and methods: Patients with advanced HCC and Child–Pugh score ≤7 received pasireotide LAR 60 mg intramuscularly every 28 days. Primary endpoint was disease control rate. Secondary endpoints were time to tumor progression, response rate, treatment-related adverse events, and overall survival. Serum insulin growth factor-1 was measured before and after pasireotide.Results: Twenty patients were treated and evaluable. Eighteen patients (90% had prior therapy; 16 patients (80% had multiple therapies. Median age was 65, 75% had Barcelona Clinic Liver Cancer stage C, and 55% had metastatic disease. The main toxicity was hyperglycemia. Rare adverse effects included reversible grade 4 elevation in alanina transaminase/aspartate transaminase in one patient. The best response was stable disease in 9 patients (45%. Median time to tumor progression for the 20 patients was 3 months, and median survival was 9 months.Conclusion: Pasireotide had limited clinical benefit as second-line or third-line treatment in patients with advanced or metastatic HCC. Low baseline insulin growth factor-1 level may be indicative when SOM230 treatment may be ineffective, and decreasing levels after treatment may be indicative of disease control. Keywords: pasireotide, hepatocellular carcinoma, insulin growth factor-1 

  1. Phase II trial of epidermal growth factor ointment for patients with Erlotinib-related skin effects.

    Science.gov (United States)

    Hwang, In Gyu; Kang, Jung Hun; Oh, Sung Yong; Lee, Suee; Kim, Sung-Hyun; Song, Ki-Hoon; Son, Choonhee; Park, Min Jae; Kang, Myung Hee; Kim, Hoon Gu; Lee, Jeeyun; Park, Young Suk; Sun, Jong Mu; Kim, Hyun Jung; Kim, Chan Kyu; Yi, Seong Yoon; Jang, Joung-Soon; Park, Keunchil; Kim, Hyo-Jin

    2016-01-01

    The efficacy of erlotinib, the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, has been demonstrated in patients with non-small cell lung cancer (NSCLC) and pancreatic cancer (PC). In the present study, we evaluated the effect of epidermal growth factor (EGF) ointment on erlotinib-related skin effects (ERSEs). This was an open-label, non-comparative, multicenter, phase II trial. The patients included those diagnosed with NSCLC or PC who were treated with erlotinib. The effectiveness of the ointment was defined as follows: (1) grade 2, 3, or 4 ERSEs downgraded to ≤ grade 1 or (2) grade 3 or 4 ERSEs downgraded to grade 2 and persisted for at least 2 weeks. Fifty-two patients from seven institutes in Korea were enrolled with informed consent. The final assessment included 46 patients (30 males, 16 females). According to the definition of effectiveness, the EGF ointment was effective in 36 (69.2%) intention to treat patients. There were no statistically significant differences in the effectiveness of the EGF ointment by gender (p = 0.465), age (p = 0.547), tumor type (p = 0.085), erlotinib dosage (p = 0.117), and number of prior chemotherapy sessions (p = 0.547). The grading for the average National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) rating of rash/acne and itching improved from 2.02 ± 0.83 to 1.13 ± 0.89 and 1.52 ± 0.84 to 0.67 ± 0.90, respectively (p reason for discontinuing the study was progression of cancer (37%). Based on the results, the EGF ointment is effective for ERSEs, regardless of gender, age, type of tumor, and dosage of erlotinib. The EGF ointment evenly improved all kinds of symptoms of ERSEs. ClinicalTrials.gov identifier: NCT01593995.

  2. Treatment of geographic atrophy with subconjunctival sirolimus: results of a phase I/II clinical trial.

    Science.gov (United States)

    Wong, Wai T; Dresner, Samuel; Forooghian, Farzin; Glaser, Tanya; Doss, Lauren; Zhou, Mei; Cunningham, Denise; Shimel, Katherine; Harrington, Molly; Hammel, Keri; Cukras, Catherine A; Ferris, Frederick L; Chew, Emily Y

    2013-04-26

    To investigate the safety and effects of subconjunctival sirolimus, an mTOR inhibitor and immunosuppressive agent, for the treatment of geographic atrophy (GA). The study was a single-center, open-label phase II trial, enrolling 11 participants with bilateral GA; eight participants completed 24 months of follow-up. Sirolimus (440 μg) was administered every 3 months as a subconjunctival injection in only one randomly assigned eye in each participant for 24 months. Fellow eyes served as untreated controls. The primary efficacy outcome measure was the change in the total GA area at 24 months. Secondary outcomes included changes in visual acuity, macular sensitivity, central retinal thickness, and total drusen area. The study drug was well tolerated with few symptoms and related adverse events. Study treatment in study eyes was not associated with structural or functional benefits relative to the control fellow eyes. At month 24, mean GA area increased by 54.5% and 39.7% in study and fellow eyes, respectively (P = 0.41), whereas mean visual acuity decreased by 21.0 letters and 3.0 letters in study and fellow eyes, respectively (P = 0.03). Substantial differences in mean changes in drusen area, central retinal thickness, and macular sensitivity were not detected for all analysis time points up to 24 months. Repeated subconjunctival sirolimus was well-tolerated in patients with GA, although no positive anatomic or functional effects were identified. Subconjunctival sirolimus may not be beneficial in the prevention of GA progression, and may potentially be associated with effects detrimental to visual acuity. (ClinicalTrials.gov number, NCT00766649.).

  3. Hyperfractionated radiation therapy for incompletely resected supratentorial low-grade glioma. A phase II study

    International Nuclear Information System (INIS)

    Jeremic, B.; Milicic, B.; Stojanovic, M.; Nikolic, N.; Dagovic, A.; Shibamoto, Y.; Grujicic, D.

    1998-01-01

    Background and purpose: In order to investigate the feasibility, toxicity and antitumor efficacy of hyperfractionated radiation therapy, 37 adult patients with incompletely resected supratentorial low-grade glioma were entered into a phase II study. Materials and methods: The radiation therapy dose was 55 Gy in 50 fractions in 25 treatment days over 5 weeks to the tumor plus a 2-cm margin, with an additional 17.6 Gy given in 16 fractions in 8 treatment days over 1.5 weeks to the tumor plus a 1-cm margin, using 1.1 Gy b.i.d. fractionation with a 6 h interfraction interval. The total tumor dose was 72.6 Gy in 66 fractions in 33 treatment days over 6.5 weeks. Results: The median survival time (MST) for all 37 patients has not yet been attained, while 5- and 7-year survival rates were 75% and 69%, respectively. The median time to tumor progression (MTP) has also not yet been attained, while 5- and 7-year progression-free survival (PFS) rates were both 70%. There was no difference in survival or PFS regarding histology, although patients with oligodendroglioma and mixed glioma had similar survival, both being higher than that of ordinary astrocytoma. On univariate analysis of potential prognostic factors, age, Karnofsky performance status (KPS), neurologic status and extent of surgery were found to influence survival. The toxicity of HFX RT was generally assessed as mild to moderate. Conclusion: HFX RT is feasible with mild to moderate toxicity. Further studies are warranted with more patients and longer follow-up before testing it against standard fractionation RT in this patient population. (Copyright (c) 1998 Elsevier Science B.V., Amsterdam. All rights reserved.)

  4. Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis.

    Directory of Open Access Journals (Sweden)

    Sara Llufriu

    Full Text Available Uncontrolled studies of mesenchymal stem cells (MSCs in multiple sclerosis suggested some beneficial effect. In this randomized, double-blind, placebo-controlled, crossover phase II study we investigated their safety and efficacy in relapsing-remitting multiple sclerosis patients. Efficacy was evaluated in terms of cumulative number of gadolinium-enhancing lesions (GEL on magnetic resonance imaging (MRI at 6 months and at the end of the study.Patients unresponsive to conventional therapy, defined by at least 1 relapse and/or GEL on MRI scan in past 12 months, disease duration 2 to 10 years and Expanded Disability Status Scale (EDSS 3.0-6.5 were randomized to receive IV 1-2×10(6 bone-marrow-derived-MSCs/Kg or placebo. After 6 months, the treatment was reversed and patients were followed-up for another 6 months. Secondary endpoints were clinical outcomes (relapses and disability by EDSS and MS Functional Composite, and several brain MRI and optical coherence tomography measures. Immunological tests were explored to assess the immunomodulatory effects.At baseline 9 patients were randomized to receive MSCs (n = 5 or placebo (n = 4. One patient on placebo withdrew after having 3 relapses in the first 5 months. We did not identify any serious adverse events. At 6 months, patients treated with MSCs had a trend to lower mean cumulative number of GEL (3.1, 95% CI = 1.1-8.8 vs 12.3, 95% CI = 4.4-34.5, p = 0.064, and at the end of study to reduced mean GEL (-2.8±5.9 vs 3±5.4, p = 0.075. No significant treatment differences were detected in the secondary endpoints. We observed a non-significant decrease of the frequency of Th1 (CD4+ IFN-γ+ cells in blood of MSCs treated patients.Bone-marrow-MSCs are safe and may reduce inflammatory MRI parameters supporting their immunomodulatory properties. ClinicalTrials.gov NCT01228266.

  5. Fractionated radiosurgery for painful spinal metastases: DOSIS - a phase II trial

    Directory of Open Access Journals (Sweden)

    Guckenberger Matthias

    2012-11-01

    vertebral site on the 0 to 10 Visual Analogue Scale. 60 patients will be included into this two-centre phase II trial. Conclusions Results of this study will refine the methods of patient selection, target volume definition, treatment planning and delivery as well as quality assurance for radiosurgery. It is the intention of this study to form the basis for a future randomized controlled trial comparing conventional radiotherapy with fractionated radiosurgery for palliation of painful vertebral metastases. Trial registration ClinicalTrials.gov Identifier: NCT01594892

  6. Fractionated radiosurgery for painful spinal metastases: DOSIS - a phase II trial

    International Nuclear Information System (INIS)

    Guckenberger, Matthias; Hawkins, Maria; Flentje, Michael; Sweeney, Reinhart A

    2012-01-01

    will be included into this two-centre phase II trial. Results of this study will refine the methods of patient selection, target volume definition, treatment planning and delivery as well as quality assurance for radiosurgery. It is the intention of this study to form the basis for a future randomized controlled trial comparing conventional radiotherapy with fractionated radiosurgery for palliation of painful vertebral metastases. ClinicalTrials.gov Identifier: NCT01594892

  7. Phase II trial of isotonic fluid resuscitation in Kenyan children with severe malnutrition and hypovolaemia

    Directory of Open Access Journals (Sweden)

    Boga Mwanamvua

    2010-10-01

    Full Text Available Abstract Background Children with severe malnutrition who develop shock have a high mortality. Contrary to contemporaneous paediatric practice, current guidelines recommend use of low dose hypotonic fluid resuscitation (half-strength Darrows/5% dextrose (HSD/5D. We evaluated the safety and efficacy of this guideline compared to resuscitation with a standard isotonic solution. Methods A Phase II randomised controlled, safety and efficacy trial in Kenyan children aged over 6 months with severe malnutrition and shock including children with severe dehydration/shock and presumptive septic shock (non-diarrhoeal shock. Eligible children were randomised to HSD/5D or Ringer's Lactate (RL. A maximum of two boluses of 15 ml/kg of HSD/5D were given over two hours (as recommended by guidelines while those randomised to RL received 10 ml/kg aliquots half hourly (maximum 40 ml/kg. Primary endpoint was resolution of shock at 8 and 24 hours. Secondary outcomes included resolution of acidosis, adverse events and mortality. Results 61 children were enrolled: 41 had shock and severe dehydrating diarrhoea, 20 had presumptive septic shock; 69% had decompensated shock. By 8 hours response to volume resuscitation was poor with shock persisting in most children:-HSD/5D 15/22 (68% and RL14/25 (52%, p = 0.39. Oliguria was more prevalent at 8 hours in the HSD/5D group, 9/22 (41%, compared to RL-3/25 (12%, p = 0.02. Mortality was high, HSD/5D-15/26(58% and RL 13/29(45%; p = 0.42. Most deaths occurred within 48 hours of admission. Neither pulmonary oedema nor cardiogenic failure was detected. Conclusions Outcome was universally poor characterised by persistence of shock, oliguria and high case fatality. Isotonic fluid was associated with modest improvement in shock and survival when compared to HSD/5D but inconclusive due to the limitations of design and effectiveness of either resuscitation strategy. Although isotonic fluid resuscitation did not result in cardiogenic heart

  8. A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II)

    International Nuclear Information System (INIS)

    Siva, Shankar; Kron, Tomas; Bressel, Mathias; Haas, Marion; Mai, Tao; Vinod, Shalini; Sasso, Giuseppe; Wong, Wenchang; Le, Hien; Eade, Thomas; Hardcastle, Nicholas; Chesson, Brent; Pham, Daniel; Høyer, Morten; Montgomery, Rebecca; Ball, David

    2016-01-01

    Stereotactic ablative body radiotherapy (SABR) is emerging as a non-invasive method for precision irradiation of lung tumours. However, the ideal dose/fractionation schedule is not yet known. The primary purpose of this study is to assess safety and efficacy profile of single and multi-fraction SABR in the context of pulmonary oligometastases. The TROG 13.01/ALTG 13.001 clinical trial is a multicentre unblinded randomised phase II study. Eligible patients have up to three metastases to the lung from any non-haematological malignancy, each < 5 cm in size, non-central targets, and have all primary and extrathoracic disease controlled with local therapies. Patients are randomised 1:1 to a single fraction of 28Gy versus 48Gy in four fractions of SABR. The primary objective is to assess the safety of each treatment arm, with secondary objectives including assessment of quality of life, local efficacy, resource use and costs, overall and disease free survival and time to distant failure. Outcomes will be stratified by number of metastases and origin of the primary disease (colorectal versus non-colorectal primary). Planned substudies include an assessment of the impact of online e-Learning platforms for lung SABR and assessment of the effect of SABR fractionation on the immune responses. A total of 84 patients are required to complete the study. Fractionation schedules have not yet been investigated in a randomised fashion in the setting of oligometastatic disease. Assuming the likelihood of similar clinical efficacy in both arms, the present study design allows for exploration of the hypothesis that cost implications of managing potentially increased toxicities from single fraction SABR will be outweighed by costs associated with delivering multiple-fraction SABR

  9. 2-Phase NSGA II: An Optimized Reward and Risk Measurements Algorithm in Portfolio Optimization

    Directory of Open Access Journals (Sweden)

    Seyedeh Elham Eftekharian

    2017-11-01

    Full Text Available Portfolio optimization is a serious challenge for financial engineering and has pulled down special attention among investors. It has two objectives: to maximize the reward that is calculated by expected return and to minimize the risk. Variance has been considered as a risk measure. There are many constraints in the world that ultimately lead to a non–convex search space such as cardinality constraint. In conclusion, parametric quadratic programming could not be applied and it seems essential to apply multi-objective evolutionary algorithm (MOEA. In this paper, a new efficient multi-objective portfolio optimization algorithm called 2-phase NSGA II algorithm is developed and the results of this algorithm are compared with the NSGA II algorithm. It was found that 2-phase NSGA II significantly outperformed NSGA II algorithm.

  10. The National Geographic Names Data Base: Phase II instructions

    Science.gov (United States)

    Orth, Donald J.; Payne, Roger L.

    1987-01-01

    The Geographic Names Information System is a computer-based information system developed to meet major national needs by providing information for named entities in the United States, its territories, and outlying areas. The National Geographic Names Data Base, a component of the Geographic Names Information System, currently contains most names and associated information recorded on the 1:24,000-scale (or largest scale available) topographic maps of the U.S. Geological Survey. The work involved in this initial compilation of names shown on the topographic-map series, and the development and editing of the National Geographic Names Data Base, is referred to as Phase I. Optimal use and effectiveness of an automated names system require that the names of features

  11. Phase II study of Gleevec® plus hydroxyurea (HU) in adults with progressive or recurrent meningioma.

    Science.gov (United States)

    Reardon, David A; Norden, Andrew D; Desjardins, Annick; Vredenburgh, James J; Herndon, James E; Coan, April; Sampson, John H; Gururangan, Sridharan; Peters, Katherine B; McLendon, Roger E; Norfleet, Julie A; Lipp, Eric S; Drappatz, Jan; Wen, Patrick Y; Friedman, Henry S

    2012-01-01

    We prospectively evaluated the efficacy and safety of imatinib plus hydroxyurea in patients with progressive/recurrent meningioma. A total of 21 patients with progressive/recurrent meningioma were enrolled in this dual center, single-arm, phase II trial. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 400 mg/day for patients not on CYP3A enzyme inducing anti-epileptic drugs (EIAEDs) and at 500 mg twice a day for patients on EIAEDs. The primary endpoint was progression-free survival at 6 months (PFS-6) and secondary endpoints were safety, radiographic response rate, and overall survival (OS). Best radiographic response was stable disease and was observed in 14 patients (67%). PFS-6 for all patients, those with grade I tumors (n = 8) and those with grade II or III tumors (n = 13) was 61.9, 87.5 and 46.2%, respectively. Patients with grade II or III tumors had poorer PFS and OS than those with grade I tumors, (P = 0.025 and P = 0.018) respectively. The only grade 3 or greater adverse event occurring in ≥ 10% of patients was anemia (10%). Imatinib plus hydroxyurea is well tolerated among patients with meningioma but has modest anti-tumor activity for this indication.

  12. An Open-Label, Multicenter, Randomized, Phase II Study of Pazopanib in Combination with Pemetrexed in First-Line Treatment of Patients with Advanced-Stage Non-Small-Cell Lung Cancer

    DEFF Research Database (Denmark)

    Scagliotti, Giorgio V; Felip, Enriqueta; Besse, Benjamin

    2013-01-01

    This randomized open-label phase II study evaluated the efficacy, safety, and tolerability of pazopanib in combination with pemetrexed compared with the standard cisplatin/pemetrexed doublet in patients with previously untreated, advanced, nonsquamous non-small-cell lung cancer....

  13. Plasma resistance behavior during the linear decay phase of RFPs in ETA BETA II

    International Nuclear Information System (INIS)

    Nalesso, G.F.

    1982-01-01

    In the aided-reversal mode RFP discharges produced in ETA BETA II, the plasma current is characterized by a linear decay phase, which follows an approximately exponential phase. During the same period the measured toroidal voltage is negative and initially increasing in absolute value (exponential phase) and then decreasing to almost zero during the linear phase before the current termination. The same behavior of the current has been observed in the quiescent phase in Zeta where a negative toroidal electric field was also observed. In this note we present a model that can explain the linear decay phase and fits with the experimental parameters and allows us to estimate the plasma resistance behavior during the linear phase of slow reversed field pinch discharges

  14. Cyprus natural analogue project (CNAP). Phase II Final Report

    International Nuclear Information System (INIS)

    Alexander, W.R.; Milodowski, A.E.

    2011-02-01

    Due to the extremely slow kinetics of bentonite reaction in low alkali cement leachates, natural analogues would appear to be the only viable method of studying bentonite reaction. As a result of a review of the available literature, several sites in Cyprus were selected as particularly promising for this purpose. This report presents the results of two short field campaigns in Cyprus in November/December, 2008 and February, 2009. The main aim of these campaigns was to establish if appropriate sites existed for a natural analogue study of bentonite-low alkali cement leachate reaction. Focus is on mineralogical changes and not changes in physical properties (such as porosity and permeability) of bentonite as the industrially-processed bentonite used in a repository will be completely different in terms of its engineering and hydrogeological properties to the unprocessed natural bentonite or analogue smectite-rich materials. The first campaign was in the form of a reconnaissance study to identify sites of likely interest and the second, follow-up, campaign focussed on obtaining preliminary groundwater and solid phase (bentonites/clay-rich sediments/altered igneous rocks/soils) samples which would allow a more detailed assessment of several of the potential sites. A large amount of information was collected during these short field campaigns and subsequent laboratory analysis of the collected samples so, to keep the main report down to a digestible size, much of the supporting information has been collated in seven appendices. These include full details of all 30 sites visited during both campaigns along with sample details, information on the analytical techniques, the analytical raw data and numerous photographs of the sites. The intention is that this report will provide full supporting information for a potential Phase III and a detailed database for our colleagues at the Geological Survey Department (GSD) in Cyprus. Consequently, all the information acquired

  15. RadSTraM: Radiological Source Tracking and Monitoring, Phase II Final Report

    Energy Technology Data Exchange (ETDEWEB)

    Warren, Tracy A [ORNL; Walker, Randy M [ORNL; Hill, David E [ORNL; Gross, Ian G [ORNL; Smith, Cyrus M [ORNL; Abercrombie, Robert K [ORNL

    2008-12-01

    This report focuses on the technical information gained from the Radiological Source Tracking and Monitoring (RadSTraM) Phase II investigation and its implications. The intent of the RadSTraM project was to determine the feasibility of tracking radioactive materials in commerce, particularly International Atomic Energy Agency (IAEA) Category 3 and 4 materials. Specifically, Phase II of the project addressed tracking radiological medical isotopes in commerce. These categories of materials are susceptible to loss or theft but the problem is not being addressed by other agencies.

  16. RadSTraM: Radiological Source Tracking and Monitoring, Phase II Final Report

    International Nuclear Information System (INIS)

    Warren, Tracy A.; Walker, Randy M.; Hill, David E.; Gross, Ian G.; Smith, Cyrus M.; Abercrombie, Robert K.

    2008-01-01

    This report focuses on the technical information gained from the Radiological Source Tracking and Monitoring (RadSTraM) Phase II investigation and its implications. The intent of the RadSTraM project was to determine the feasibility of tracking radioactive materials in commerce, particularly International Atomic Energy Agency (IAEA) Category 3 and 4 materials. Specifically, Phase II of the project addressed tracking radiological medical isotopes in commerce. These categories of materials are susceptible to loss or theft but the problem is not being addressed by other agencies

  17. Plasma-wall Interaction Studies in the Start-up Phase of TJ-II

    International Nuclear Information System (INIS)

    De la Cal, E.; Tabares, F.L.; Tafalla, D.

    1998-01-01

    The aim of this work is to present some first plasma-wall interaction studies made during the first experimental campaign of TJ-II. The different sections contain independent contributions presented orally in the fusion division of the Euratom-Ciemat association during 1998: I. Density limit during the start-up phase of TJ-II : are we limited by radiation?. II. Temporal evolution of oxygen in the plasma during an experimental day. III. The contribution of helium to the plasma electron density IV. First studies of the S.O.L. diffusion coefficient and its dependence with the boundary plasma parameters. (Author) 3 refs

  18. Phase I/II Multi-Institutional Study of Percutaneous Radiofrequency Ablation for Painful Osteoid Osteoma (JIVROSG-0704)

    Energy Technology Data Exchange (ETDEWEB)

    Miyazaki, Masaya, E-mail: mmiyazak@gunma-u.ac.jp [Gunma University Hospital, Department of Interventional Radiology and Clinical Ultrasound Center (Japan); Arai, Yasuaki [National Center Hospital, Division of Diagnostic Radiology (Japan); Myoui, Akira [Osaka University Hospital, Medical Center for Translational Research (Japan); Gobara, Hideo [Okayama University Medical School, Department of Radiology (Japan); Sone, Miyuki [National Center Hospital, Division of Diagnostic Radiology (Japan); Rosenthal, Daniel I. [Harvard Medical School, Department of Radiology, Massachusetts General Hospital (United States); Tsushima, Yoshito [Gunma University Hospital, Department of Interventional Radiology and Clinical Ultrasound Center (Japan); Kanazawa, Susumu [Okayama University Medical School, Department of Radiology (Japan); Ehara, Shigeru [Iwate Medical University School of Medicine, Department of Radiology (Japan); Endo, Keigo [Gunma University Hospital, Department of Interventional Radiology and Clinical Ultrasound Center (Japan)

    2016-10-15

    PurposeThis multicenter prospective study was conducted to evaluate the safety and efficacy of percutaneous radiofrequency ablation (RFA) for painful osteoid osteoma (OO).Materials and MethodsPatients with OO (femur: n = 17, tibia: n = 2, humerus: n = 1, rib: n = 1) were enrolled and treated with RFA. In phase I, nine patients were evaluated for safety. In phase II, 12 patients were accrued, and an intent-to-treat analysis was performed on all patients. The primary endpoint was to evaluate the treatment safety. The secondary endpoint was to evaluate the efficacy for pain relief by the visual analogue scale (VAS) at 4 weeks after RFA. Treatment efficacy was classified as significantly effective (SE) when VAS score decreased by ≥5 or score was <2, moderately effective when VAS score decreased by <5–≥2 and score was ≥2, and not effective (NE) when VAS score decreased by <2 or score was increased. Cases where the need for analgesics increased after treatment were also NE.ResultsRFA procedures were completed in all patients. Minor adverse effects (AEs) were observed as 4.8–14.3 % in 12 patients, and no major AEs were observed. Mean VAS score was 7.1 before treatment, 1.6 at 1 week, 0.3 at 4 weeks, and 0.2 at 3 months. All procedures were classified as SE. Pain recurrence was not noted in any patient during follow-up (mean: 15.1 months).ConclusionRFA is a safe, highly effective, and fast-acting treatment for painful extraspinal OO. Future studies with a greater number of patients are needed.

  19. ATLAS calorimeters: Run-2 performances and Phase-II upgrades

    CERN Document Server

    Boumediene, Djamel Eddine; The ATLAS collaboration

    2017-01-01

    The ATLAS detector was designed and built to study proton-proton collisions produced at the LHC at centre-of-mass energies up to 14 TeV and instantaneous luminosities up to $10^{34} cm^{-2} s^{-1}$. A Liquid Argon-lead sampling (LAr) calorimeter is employed as electromagnetic and hadronic calorimeters, except in the barrel region, where a scintillator-steel sampling calorimeter (TileCal) is used as hadronic calorimeter. This presentation gives first an overview of the detector operation and data quality, as well as of the achieved performances of the ATLAS calorimetry system. Additionally the upgrade projects of the ATLAS calorimeter system for the high luminosity phase of the LHC (HL-LHC) are presented. For the HL-LHC, the instantaneous luminosity is expected to increase up to $L \\simeq 7.5 × 10^{34} cm^{-2} s^{-1}$ and the average pile-up up to 200 interactions per bunch crossing. The major R&D item is the upgrade of the electronics for both LAr and Tile calorimeters in order to cope with longer latenc...

  20. The Phase II Upgrade of the ATLAS Calorimeter

    CERN Document Server

    Tartarelli, Giuseppe Francesco; The ATLAS collaboration

    2017-01-01

    This presentation will show the status of the upgrade projects of the ATLAS calorimeter system for the high luminosity phase of the LHC (HL-LHC). For the HL-LHC, the instantaneous luminosity is expected to increase up to L ≃ 7.5 × 1034 cm−2 s−1 and the average pile-up up to 200 interactions per bunch crossing. The Liquid Argon (LAr) calorimeter electronics will need to be replaced to cope with these challenging conditions: the expected radiation doses will indeed exceed the qualification range of the current readout system, and the upgraded trigger system will require much longer data storage in the electronics (up to 60 us), that the current system cannot sustain. The status of the R&D of the low-power ASICs (pre-amplifier, shaper, ADC, serializer and transmitters) and of the readout electronics design will be discussed. Moreover, a High Granularity Timing Detector (HGTD) is proposed to be added in front of the LAr calorimeters in the end-cap region (2.4 <|eta|< 4.2) for pile-up mitigation a...

  1. The Phase-II ATLAS ITk Pixel Upgrade

    CERN Document Server

    AUTHOR|(INSPIRE)INSPIRE-00349918; The ATLAS collaboration

    2017-01-01

    The entire tracking system of the ATLAS experiment will be replaced during the LHC Phase~2 shutdown (foreseen to take place around 2025) by an all-silicon detector called the ``ITk'' (Inner Tracker). The innermost portion of ITk will consist of a pixel detector with five layers in the barrel region and ring-shaped supports in the end-cap regions. It will be instrumented with new sensor and readout electronics technologies to improve the tracking performance and cope with the HL-LHC environment, which will be severe in terms of occupancy and radiation levels. The new pixel system could include up to 14 $\\mathrm{m^2}$ of silicon, depending on the final layout, which is expected to be decided in 2017. Several layout options are being investigated at the moment, including some with novel inclined support structures in the barrel end-cap overlap region and others with very long innermost barrel layers. Forward coverage could be as high as |eta| $<4$. Supporting structures will be based on low mass, highly stabl...

  2. ATLAS Calorimeters: Run-2 performance and Phase-II upgrade

    CERN Document Server

    Boumediene, Djamel Eddine; The ATLAS collaboration

    2017-01-01

    The ATLAS detector was designed and built to study proton-proton collisions produced at the LHC at centre-of-mass energies up to 14 TeV and instantaneous luminosities up to 10^{34} cm^{−2} s^{−1}. A liquid argon (LAr)-lead sampling calorimeter is employed as electromagnetic calorimeter and hadronic calorimter, except in the barrel region, where a scintillator-steel sampling calorimeter (TileCal) is used as hadronic calorimter. This presentation will give first an overview of the detector operation and data quality, as well as the achieved performance of the ATLAS calorimetry system. Additionally, the upgrade projects of the ATLAS calorimeter system for the high luminosity phase of the LHC (HL-LHC) will be presented. For the HL-LHC, the instantaneous luminosity is expected to increase up to L ≃ 7.5 × 10^{34} cm^{−2} s^{−1} and the average pile-up up to 200 interactions per bunch crossing. The major R&D item is the upgrade of the electronics for both LAr and Tile calorimeters in order to cope wit...

  3. Treatment of geographic atrophy by the topical administration of OT-551: results of a phase II clinical trial.

    Science.gov (United States)

    Wong, Wai T; Kam, Waynekid; Cunningham, Denise; Harrington, Molly; Hammel, Keri; Meyerle, Catherine B; Cukras, Catherine; Chew, Emily Y; Sadda, Srinivas R; Ferris, Frederick L

    2010-12-01

    To investigate the safety and preliminary efficacy of OT-551, a disubstituted hydroxylamine with antioxidant properties, for the treatment of geographic atrophy (GA), the advanced atrophic form of age-related macular degeneration (AMD). The study was a single-center, open-label phase II trial, enrolling 10 participants with bilateral GA. Topical 0.45% OT-551 was administered in one randomly assigned eye three times daily for 2 years. Safety measures were assessed by complete ophthalmic examination, fundus photography, and review of symptoms. The primary efficacy outcome measure was the change in best corrected visual acuity at 24 months. Secondary efficacy measures included changes in area of GA, contrast sensitivity, microperimetry measurements, and total drusen area from baseline. Study drug was well tolerated and was associated with few adverse events. The mean change in BCVA at 2 years was +0.2 ± 13.3 letters in the study eyes and -11.3 ± 7.6 letters in fellow eyes (P = 0.0259). However, no statistically significant differences were found between the study and fellow eyes for all other secondary outcome measures. OT-551 was well tolerated by study participants and was not associated with any serious adverse effects. Efficacy measurements in this small study indicate a possible effect in maintaining visual acuity. However, the absence of significant effects on other outcomes measures in this study suggests that OT-551, in the current concentration and mode of delivery, may have limited or no benefit as a treatment for GA (ClinicalTrials.gov number, NCT00306488).

  4. Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

    Science.gov (United States)

    Langrand-Escure, Julien; Rivoirard, Romain; Oriol, Mathieu; Tinquaut, Fabien; Rancoule, Chloé; Chauvin, Frank; Magné, Nicolas; Bourmaud, Aurélie

    2017-01-01

    Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials. A literature review was conducted among all phase II and phase II/III clinical trials published during a 5-year period (2010-2015). All articles electronically published by three randomly-selected oncology journals with Impact-Factors>4 were included: Journal of Clinical Oncology, Annals of Oncology and British Journal of Cancer. Quality of reporting was assessed using the Key Methodological Score. 557 articles were included. 315 trials were single-arm studies (56.6%), 193 (34.6%) were randomized and 49 (8.8%) were non-randomized multiple-arm studies. The Methodological Score was equal to 0 (lowest level), 1, 2, 3 (highest level) respectively for 22 (3.9%), 119 (21.4%), 270 (48.5%) and 146 (26.2%) articles. The primary end point is almost systematically reported (90.5%), while sample size calculation is missing in 66% of the articles. 3 variables were independently associated with reporting of a high standard: presence of statistical design (p-value <0.001), multicenter trial (p-value = 0.012), per-protocol analysis (p-value <0.001). Screening was mainly performed by a sole author. The Key Methodological Score was based on only 3 items, making grey zones difficult to translate. This literature review highlights the existence of gaps concerning the quality of reporting. It therefore raised the question of the suitability of the methodology as well as the quality of these trials, reporting being incomplete in the corresponding articles.

  5. Development of methods for measuring materials nuclear characteristics, Phases, I, II, II and IV

    International Nuclear Information System (INIS)

    Maglic, R.

    1963-04-01

    This report contains the following phases of the project 'measurement of nuclear characteristics of reactor materials': nuclear performances of the neutron chopper; method for measuring total effective cross sections by transmission method on the chopper; review of methods for measuring activation cross sections; measurement of neutron spectra of the RA reactor and measurement of total effective cross section of gold by using the chopper

  6. Stable Low Cloud Phase II: Nocturnal Event Study

    Science.gov (United States)

    Bauman, William H., III; Barrett, Joe, III

    2007-01-01

    This report describes the work done by the Applied Meteorology Unit (AMU) in developing a database of nights that experienced rapid (formation in a stable atmosphere, resulting in ceilings at the Shuttle Landing Facility (TTS) that violated Space Shuttle Flight Rules (FR). This work is the second phase of a similar AMU task that examined the same phenomena during the day. In the first phase of this work, the meteorological conditions favoring the rapid formation of low ceilings include the presence of any inversion below 8000 ft, high relative humidity (RH) beneath the inversion and a clockwise turning of the winds from the surface to the middle troposphere (-15000 ft). The AMU compared and contrasted the atmospheric and thermodynamic conditions between nights with rapid low ceiling formation and nights with low ceilings resulting from other mechanisms. The AMU found that there was little to discern between the rapidly-forming ceiling nights and other low ceiling nights at TTS. When a rapid development occurred, the average RH below the inversions was 87% while non-events had an average RH of 79%. One key parameter appeared to be the vertical wind profile in the Cape Canaveral, FL radiosonde (XMR) sounding. Eighty-three percent of the rapid development events had veering winds with height from the surface to the middle troposphere (-15,000 ft) while 61% of the non-events had veering winds with height. Veering winds indicate a warm-advection regime, which supports large-scale rising motion and ultimately cloud formation in a moist environment. However, only six of the nights (out of 86 events examined) with low cloud ceilings had an occurrence of rapidly developing ceilings. Since only 7% rapid development events were observed in this dataset, it is likely that rapid low cloud development is not a common occurrence during the night, or at least not as common as during the day. In the AMU work on the daytime rapid low cloud development (Case and Wheeler 2005), nearly

  7. Purification and H-1 NMR spectroscopic characterization of phase II metabolites of tolfenamic acid

    DEFF Research Database (Denmark)

    Sidelmann, U. G.; Christiansen, E.; Krogh, L.

    1997-01-01

    samples obtained on days 7 to 10 from a human volunteer after oral administration of 200 mg of the drug three times per day (steady-state plasma concentration). The metabolites of tolfenamic acid were initially concentrated by preparative solid phase extraction (PSPE) chromatography, thereby removing...... the endogenous polar compounds that are present in the urine. The individual metabolites were purified by preparative high performance liquid chromatography (HPLC) and then identified using H-1 NMR, Both one- and two-dimensional NMR experiments were performed to identify the phase II metabolites of tolfenamic......), and N-(2-methyl-4-hydroxyphenyl)-anthranilic acid (11) were identified. The phase II metabolites (5-11) had not previously been identified in urine from humans administered tolfenamic acid. The phase I metabolites of the glucuronides 7, 8, 10, and 11 were identified here for the first time. An HPLC...

  8. An FPGA-based trigger for the phase II of the MEG experiment

    Energy Technology Data Exchange (ETDEWEB)

    Baldini, A. [Istituto Nazionale di Fisica Nucleare, Pisa (Italy); Bemporad, C.; Cei, F. [Istituto Nazionale di Fisica Nucleare, Pisa (Italy); Dipartimento di Fisica, Università di Pisa (Italy); Galli, L.; Grassi, M.; Morsani, F. [Istituto Nazionale di Fisica Nucleare, Pisa (Italy); Nicolò, D., E-mail: donato.nicolo@pi.infn.it [Istituto Nazionale di Fisica Nucleare, Pisa (Italy); Dipartimento di Fisica, Università di Pisa (Italy); Ritt, S. [Paul Scherrer Institut, Villigen AG (Switzerland); Venturini, M. [Istituto Nazionale di Fisica Nucleare, Pisa (Italy); Scuola Normale Superiore, Pisa (Italy)

    2016-07-11

    For the phase II of MEG, we are going to develop a combined trigger and DAQ system. Here we focus on the former side, which operates an on-line reconstruction of detector signals and event selection within 450 μs from event occurrence. Trigger concentrator boards (TCB) are under development to gather data from different crates, each connected to a set of detector channels, to accomplish higher-level algorithms to issue a trigger in the case of a candidate signal event. We describe the major features of the new system, in comparison with phase I, as well as its performances in terms of selection efficiency and background rejection. - Highlights: • A new, two-level trigger scheme for the phase-II of the MEG experiment is presented. • Improvements with respect to phase-I are underlined. • The role of detector upgrades and the use of a new generation of FPGA as well are emphasized.

  9. Project NOAH: Regulating modern sea-level rise. Phase II: Jerusalem Underground

    Science.gov (United States)

    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”.

  10. Long-term safety and efficacy of dasatinib in the treatment of chronic-phase chronic myeloid leukemia patients resistant or intolerant to imatinib

    Directory of Open Access Journals (Sweden)

    Shoumariyeh K

    2014-09-01

    Full Text Available Khalid Shoumariyeh, Nikolas von BubnoffDepartment of Hematology, Oncology and Stem Cell Transplantation, University Hospital Freiburg, Freiburg, Germany Abstract: Treatment of chronic myeloid leukemia (CML has undergone dramatic changes in the last decade. Dissecting the molecular pathways that lead to the development of this disease resulted in the development of targeted therapy against the molecular driver of CML, namely the aberrantly activated tyrosine kinase BCR-ABL1. By introducing the tyrosine kinase inhibitor imatinib to the treatment repertoire, the natural course of the disease has been dramatically altered and overall survival of patients with CML prolonged substantially. Nevertheless, a significant number of patients are primarily resistant, acquire resistance during the course of their disease, or do not tolerate the intake of imatinib due to adverse effects. Second-generation tyrosine kinase inhibitors were developed in an attempt to overcome these problems. Dasatinib is a potent oral kinase inhibitor that was originally developed as an Src-kinase inhibitor but exhibited promising potency against BCR-ABL1 as well. Phase I and II trials demonstrated efficacy in patients failing imatinib, and thus dasatanib was approved in 2006 for the treatment of imatinib-resistant or -intolerant patients with chronic-phase CML harboring the BCR-ABL1 fusion protein. It has since shown promising efficacy and good overall tolerability in subsequent clinical trials, including the Phase III first-line DASISION trial that led to the extension of its approval for first-line treatment of chronic-phase CML. The following review summarizes the available data on the long-term efficacy and safety of dasatinib as a second-line therapy in chronic-phase CML. Keywords: BCR-ABL1, TKI, CML-CP, second-line treatment

  11. Nonlinear Aerodynamic and Nonlinear Structures Interations (NANSI) Methodology for Ballute/Inflatable Aeroelasticity in Hypersonic Atmospheric Entry, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — ZONA proposes a phase II effort to fully develop a comprehensive methodology for aeroelastic predictions of the nonlinear aerodynamic/aerothermodynamic - structure...

  12. Forum of stakeholder confidence - Phase II of program of work

    International Nuclear Information System (INIS)

    Le Bars, Yves

    2006-01-01

    The author welcomed the Forum for Stakeholder Confidence (FSC) participants and introduced the day's meetings that would investigate the possible contributions and conditions for RD and D to support stakeholder confidence. In his introductory remarks, Mr. Le Bars reviewed the intent of this topical discussion and its contribution to the Phase 2 Programme of Work for FSC. Observations were drawn from previous FSC work concerning the evolving requirements for stakeholder involvement that require a new culture within the organizations. It is recognized that each actor must respect certain values and abilities, and have the capacity to communicate, to learn from the public and to adapt. In particular, it was suggested that the role of the expert in the decision-making process has changed, and there is a need to restore credibility to the voice of experts to support the processes relating to radioactive waste management. Mr. Le Bars spoke about the changing role of the 'expert' and increasing demands from the public to be informed, active participants in decision-making processes. As societal expectations have evolved over the years, there is less willingness to give the expert the legitimacy to decide, or the expert working solely with the decision-maker. Rather, there are growing demands for public policies to be defined and implemented through decision-making processes that also invite stakeholder participation, as another important category of actors. Thus, the decision-making process can be viewed as now involving three parties: the public, the experts and decision-makers. Research must be positioned in this context. Research must be part of the process, structure, behaviour and debate. It is meant to be introduced in the process as contributor to the project definition, by providing scientific background. Further, it is best undertaken through an adaptive behaviour, carried out by institutions with a clearly defined and communicated role. In setting

  13. Phase II Results of RTOG 0537: A Phase II/III Study Comparing Acupuncture-like Transcutaneous Electrical Nerve Stimulation Versus Pilocarpine in Treating Early Radiation-Induced Xerostomia

    Science.gov (United States)

    Wong, Raimond K. W.; James, Jennifer L.; Sagar, Stephen; Wyatt, Gwen; Nguyen-Tân, Phuc Felix; Singh, Anurag K.; Lukaszczyk, Barbara; Cardinale, Francis; Yeh, Alexander M.; Berk, Lawrence

    2011-01-01

    Purpose This phase II component of a multi-institutional phase II/III randomized trial assessed the feasibility and preliminary efficacy of acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) in reducing radiation-induced xerostomia. Methods Head and neck cancer patients who were 3–24 months from completing radiotherapy ± chemotherapy (RT±C) and experiencing xerostomia symptoms with basal whole saliva production ≥0.1 ml/min and without recurrence were eligible. Patients received twice weekly ALTENS sessions (24 over 12 weeks) using a Codetron™ unit. The primary objective assessed the feasibility of ALTENS treatment. A patient was considered compliant if 19/24 ALTENS were delivered, with a targeted 85% compliance rate. Secondary objectives measured treatment-related toxicities and ALTENS effect on overall radiation-induced xerostomia burden using the University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS). Results Of 48 accrued patients, 47 were evaluable. Median age was 60 years; 84% were male, 70% completed RT±C for > 12 months and 21% had received prior pilocarpine. All ALTENS sessions were completed in 34 patients, but 9 and 1 completed 20–23 and 19 sessions respectively, representing a 94% total compliance rate. 6-month XeQOLS scores were available for 35 patients; 30 (86%) achieved a positive treatment response with a mean reduction of 35.9% (SD 36.1). Five patients developed grade 1–2 gastrointestinal toxicity and one had grade 1 pain event. Conclusions ALTENS treatment for radiation-induced xerostomia can be uniformly delivered in a cooperative multicenter setting and has possible beneficial treatment response. Given these results, the phase III component of this study was initiated. PMID:22252927

  14. Treatment of nonneovascular idiopathic macular telangiectasia type 2 with intravitreal ranibizumab: results of a phase II clinical trial.

    Science.gov (United States)

    Toy, Brian C; Koo, Euna; Cukras, Catherine; Meyerle, Catherine B; Chew, Emily Y; Wong, Wai T

    2012-05-01

    To evaluate the safety and preliminary efficacy of intravitreal ranibizumab for nonneovascular idiopathic macular telangiectasia Type 2. Single-center, open-label Phase II clinical trial enrolling five participants with bilateral nonneovascular idiopathic macular telangiectasia Type 2. Intravitreal ranibizumab (0.5 mg) was administered every 4 weeks in the study eye for 12 months with the contralateral eye observed. Outcome measures included changes in best-corrected visual acuity, area of late-phase leakage on fluorescein angiography, and retinal thickness on optical coherence tomography. The study treatment was well tolerated and associated with few adverse events. Change in best-corrected visual acuity at 12 months was not significantly different between treated study eyes (0.0 ± 7.5 letters) and control fellow eyes (+2.2 ± 1.9 letters). However, decreases in the area of late-phase fluorescein angiography leakage (-33 ± 20% for study eyes, +1 ± 8% for fellow eyes) and in optical coherence tomography central subfield retinal thickness (-11.7 ± 7.0% for study eyes and -2.9 ± 3.5% for fellow eyes) were greater in study eyes compared with fellow eyes. Despite significant anatomical responses to treatment, functional improvement in visual acuity was not detected. Intravitreal ranibizumab administered monthly over a time course of 12 months is unlikely to provide a general and significant benefit to patients with nonneovascular idiopathic macular telangiectasia Type 2.

  15. Treatment of Non-neovascular Idiopathic Macular Telangiectasia Type 2 with Intravitreal Ranibizumab: Results of a Phase II Clinical Trial

    Science.gov (United States)

    Toy, Brian C.; Koo, Euna; Cukras, Catherine; Meyerle, Catherine B.; Chew, Emily Y.; Wong, Wai T.

    2015-01-01

    Purpose To evaluate the safety and preliminary efficacy of intravitreal ranibizumab for non-neovascular idiopathic macular telangiectasia, type 2 (IMT2). Methods Single-center, open-label phase II clinical trial enrolling 5 participants with bilateral non-neovascular IMT2. Intravitreal ranibizumab (0.5mg) was administered every 4 weeks in the study eye for 12 months with the contralateral eye observed. Outcome measures included changes in: best corrected visual acuity (BCVA), area of late-phase leakage on fluorescein angiography (FA), and retinal thickness on optical coherence tomography (OCT). Results The study treatment was well-tolerated and associated with few adverse events. Change in BCVA at 12 months was not significantly different between treated study eyes (0.0±7.5 letters) and control fellow eyes (+2.2±1.9 letters). However, decreases in the area of late-phase FA leakage (−33±20% for study eyes, +1±8% for fellow eyes) and in OCT central subfield retinal thickness (−11.7±7.0% for study eyes and −2.9±3.5% for fellow eyes) were greater in study eyes compared to fellow eyes. Conclusions Despite significant anatomical responses to treatment, functional improvement in visual acuity was not detected. Intravitreal ranibizumab administered monthly over a time course of 12 months is unlikely to provide a general and significant benefit to patients with non-neovascular IMT2. PMID:22266930

  16. A randomized phase II dose-response exercise trial among colon cancer survivors: Purpose, study design, methods, and recruitment results.

    Science.gov (United States)

    Brown, Justin C; Troxel, Andrea B; Ky, Bonnie; Damjanov, Nevena; Zemel, Babette S; Rickels, Michael R; Rhim, Andrew D; Rustgi, Anil K; Courneya, Kerry S; Schmitz, Kathryn H

    2016-03-01

    Observational studies indicate that higher volumes of physical activity are associated with improved disease outcomes among colon cancer survivors. The aim of this report is to describe the purpose, study design, methods, and recruitment results of the courage trial, a National Cancer Institute (NCI) sponsored, phase II, randomized, dose-response exercise trial among colon cancer survivors. The primary objective of the courage trial is to quantify the feasibility, safety, and physiologic effects of low-dose (150 min·week(-1)) and high-dose (300 min·week(-1)) moderate-intensity aerobic exercise compared to usual-care control group over six months. The exercise groups are provided with in-home treadmills and heart rate monitors. Between January and July 2015, 1433 letters were mailed using a population-based state cancer registry; 126 colon cancer survivors inquired about participation, and 39 were randomized onto the study protocol. Age was associated with inquiry about study participation (Pclinical, or geographic characteristics were associated with study inquiry or randomization. The final trial participant was randomized in August 2015. Six month endpoint data collection was completed in February 2016. The recruitment of colon cancer survivors into an exercise trial is feasible. The findings from this trial will inform key design aspects for future phase 2 and phase 3 randomized controlled trials to examine the efficacy of exercise to improve clinical outcomes among colon cancer survivors. Copyright © 2016 Elsevier Inc. All rights reserved.

  17. A Multi-Band Photonic Phased Array Antenna for High-Data Rate Communication, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Multi-band phased array antenna (PAA) can reduce the number of antennas on shipboard platforms while offering significantly improved performance. In order to steer...

  18. Impact of Dengue Vaccination on Serological Diagnosis: Insights From Phase III Dengue Vaccine Efficacy Trials.

    Science.gov (United States)

    Plennevaux, Eric; Moureau, Annick; Arredondo-García, José L; Villar, Luis; Pitisuttithum, Punnee; Tran, Ngoc H; Bonaparte, Matthew; Chansinghakul, Danaya; Coronel, Diana L; L'Azou, Maïna; Ochiai, R Leon; Toh, Myew-Ling; Noriega, Fernando; Bouckenooghe, Alain

    2018-04-03

    We previously reported that vaccination with the tetravalent dengue vaccine (CYD-TDV; Dengvaxia) may bias the diagnosis of dengue based on immunoglobulin M (IgM) and immunoglobulin G (IgG) assessments. We undertook a post hoc pooled analysis of febrile episodes that occurred during the active surveillance phase (the 25 months after the first study injection) of 2 pivotal phase III, placebo-controlled CYD-TDV efficacy studies that involved ≥31000 children aged 2-16 years across 10 countries in Asia and Latin America. Virologically confirmed dengue (VCD) episode was defined with a positive test for dengue nonstructural protein 1 antigen or dengue polymerase chain reaction. Probable dengue episode was serologically defined as (1) IgM-positive acute- or convalescent-phase sample, or (2) IgG-positive acute-phase sample and ≥4-fold IgG increase between acute- and convalescent-phase samples. There were 1284 VCD episodes (575 and 709 in the CYD-TDV and placebo groups, respectively) and 17673 other febrile episodes (11668 and 6005, respectively). Compared with VCD, the sensitivity and specificity of probable dengue definition were 93.1% and 77.2%, respectively. Overall positive and negative predictive values were 22.9% and 99.5%, respectively, reflecting the much lower probability of correctly confirming probable dengue in a population including a vaccinated cohort. Vaccination-induced bias toward false-positive diagnosis was more pronounced among individuals seronegative at baseline. Caution will be required when interpreting IgM and IgG data obtained during routine surveillance in those vaccinated with CYD-TDV. There is an urgent need for new practical, dengue-specific diagnostic algorithms now that CYD-TDV is approved in a number of dengue-endemic countries. NCT01373281 and NCT01374516.

  19. Causalities between CO2, electricity, and other energy variables during phase I and phase II of the EU ETS

    International Nuclear Information System (INIS)

    Keppler, Jan Horst; Mansanet-Bataller, Maria

    2010-01-01

    The topic of this article is the analysis of the interplay between daily carbon, electricity and gas price data with the European Union Emission Trading System (EU ETS) for CO 2 emissions. In a first step we have performed Granger causality tests for Phase I of the EU ETS (January 2005 until December 2007) and the first year of Phase II of the EU ETS (2008). The analysis includes both spot and forward markets - given the close interactions between the two sets of markets. The results show that during Phase I coal and gas prices, through the clean dark and spark spread, impacted CO 2 futures prices, which in return Granger caused electricity prices. During the first year of the Phase II, the short-run rent capture theory (in which electricity prices Granger cause CO 2 prices) prevailed. On the basis of the qualitative results of the Granger causality tests we obtained the formulation testable equations for quantitative analysis. Standard OLS regressions yielded statistically robust and theoretically coherent results. (author)

  20. Developing maintainability for tokamak fusion power systems. Phase II report. Volume II: study results

    International Nuclear Information System (INIS)

    Fuller, G.M.; Zahn, H.S.; Mantz, H.C.; Kaletta, G.R.; Waganer, L.M.; Carosella, L.A.; Conlee, J.L.

    1978-11-01

    In this second phase the impact of unscheduled maintenance, several vacuum wall arrangements, and maintenance of other reactor interfacing subsystems and maintenance equipment are added to the evaluation of the maintainability of the fusion power reactor concepts. Four concepts are normalized to common performance parameters and evaluated for their capability to achieve availability and cost of electricity goals considering both scheduled and unscheduled maintenance. The results of this evaluation are used to generate a series of maintainability design guidelines and to select the more desirable features and design options which are used to configure a preliminary reactor concept having improved maintainability

  1. Major therapeutic effect of pentoxifylline-tocopherol association in the superficial radioinduced fibrosis: phase II test

    International Nuclear Information System (INIS)

    Delanian, S.; Balla-Mekias, S.; Maylin, C.; Lefaix, J.L.

    1997-01-01

    The association of pentoxifylline-tocopherol seems efficient in the reduction of the superficial human radioinduced fibrosis. This phase II invites to realize a randomized test and to a comparison with the results got with the dismutase superoxide. (N.C.)

  2. Prospera Digital Phase II: Financial inclusion for low-income women ...

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

    Prospera Digital Phase II: Financial inclusion for low-income women in Mexico ... a research network in Latin America, to identify barriers and opportunities to scale up ... Call for new OWSD Fellowships for Early Career Women Scientists now open ... conference of McGill's Institute for the Study of International Development.

  3. TA 55 Reinvestment Project II Phase C Update Project Status May 23, 2017

    Energy Technology Data Exchange (ETDEWEB)

    Giordano, Anthony P. [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-05-25

    The TA-55 Reinvestment Project (TRP) II Phase C is a critical infrastructure project focused on improving safety and reliability of the Los Alamos National Laboratory (LANL) TA-55 Complex. The Project recapitalizes and revitalizes aging and obsolete facility and safety systems providing a sustainable nuclear facility for National Security Missions.

  4. Kilowatt isotope power system, Phase II Plan. Volume IV. Teledyne FSCD vs GDS

    Energy Technology Data Exchange (ETDEWEB)

    1978-03-15

    This Volume contains Teledyne's input to the Kilowatt Isotope Power System Phase II Plan. Included is a description of the Flight System Heat Generation System, Flight System Radiator, Thermal Insulation Stability, GDS Heat Generation System and GDS Radiator.

  5. Social Security in Zimbabwe : Phase II: Zunde raMambo and Burial ...

    African Journals Online (AJOL)

    In Phase II of this study the Zimbabwean team selected the Zunde raMambo and burial societies for an in-depth study. Four provinces were selected and key informants were interviewed from senior officials to members of these organizations at the grassroots. Zunde raMambo, which provide for the contingency of famine ...

  6. 76 FR 55947 - Industrial Relations Promotion Project, Phase II in Vietnam

    Science.gov (United States)

    2011-09-09

    ... DEPARTMENT OF LABOR Office of the Secretary Industrial Relations Promotion Project, Phase II in... to perform the type of activity to be funded.. DAI, through its Industrial Relations Promotion... provided a letter in support of continued funding of DAI/IRRP based, on part, on the importance of the...

  7. VTAE Equity Staff Development Workshops and Services--Phase II. Final Report.

    Science.gov (United States)

    Baldus, Lorayne; Nelson, Orville

    The Phase II Equity Staff Development project was revised in response to a need to develop an equity strategic planning model with a vision statement, goals, and objectives. The Equity Strategic Planning Model was presented to administrators of Wisconsin Vocational, Technical, and Adult Education (VTAE) colleges for their use in district strategic…

  8. Human Rights and Peace Audit on Partition in South Asia - Phase II ...

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

    3 févr. 2009 ... Human Rights and Peace Audit on Partition in South Asia - Phase II. In South Asia, people's social, political and cultural aspirations often get articulated as movements for territorially defined political change. Very often, these movements find resolution in partition or in an ethnic group/nationality getting ...

  9. A phase II study of gemcitabine in the treatment of non small cell lung cancer

    NARCIS (Netherlands)

    LeChevalier, T; Gottfried, M; Gatzemeier, U; Shepherd, F; Weynants, P; Cottier, B; Groen, HJM; Rosso, R; Mattson, K; CortesFunes, H; Tonato, M; Burkes, RL; Voi, M; Ponzio, A

    Gemcitabine is a novel pyrimidine nucleoside whose activity has been demonstrated on solid tumors. We report here the results of a multicentre phase II trial of gemcitabine in chemonaive patients with inoperable non small cell lung cancer (NSCLC). Gemcitabine was given weekly at a dose of 1,250

  10. Studies of Inner Detector Layouts with 5 Pixel layers for the Phase-II Upgrade

    CERN Document Server

    Ludwig, A; The ATLAS collaboration; Garcia-Sciveres, M

    2013-01-01

    This note describes a study of Inner Detector layouts for the phase-II upgrade. Starting from the LOI layout the impact of adding a 5th pixel layer, and shortening the pixel and/or SCT barrel layers is studied.

  11. 40 CFR 300.305 - Phase II-Preliminary assessment and initiation of action.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 27 2010-07-01 2010-07-01 false Phase II-Preliminary assessment and initiation of action. 300.305 Section 300.305 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... the OSC is informed of their activities in natural resource damage assessment that may affect response...

  12. 77 FR 73586 - Further Inquiry Into Issues Related to Mobility Fund Phase II

    Science.gov (United States)

    2012-12-11

    ... highest cost areas. 17. Small business participation. In the USF/ICC Transformation Order and FNPRM, the... Phase II of the Mobility Fund. As established in the USF/ICC Transformation Order and FNPRM, 76 FC 78383... previously filed in response to the USF/ICC Transformation Order and FNPRM and the Bureaus' experience in...

  13. A phase II study of gemcitabine in patients with malignant pleural mesothelioma

    NARCIS (Netherlands)

    van Meerbeeck, JP; Bass, P; Debruyne, C; Groen, HJ; Manegold, C; Ardizzoni, A; Gridelli, C; van Marck, EA; Lentz, M; Giaccone, G

    1999-01-01

    BACKGROUND, Gemcitabine has shown activity in patients with less chemosensitive solid tumors. Phase II screening of novel drugs is an accepted method with which to investigate new therapies in malignant mesothelioma. The European Organization for Research and Treatment of Cancer-Lung Cancer

  14. Life cycle and economic efficiency analysis phase II : durable pavement markings.

    Science.gov (United States)

    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...

  15. 40 CFR 76.7 - Revised NOX emission limitations for Group 1, Phase II boilers.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Revised NOX emission limitations for Group 1, Phase II boilers. 76.7 Section 76.7 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.7 Revised NOX...

  16. 40 CFR 76.8 - Early election for Group 1, Phase II boilers.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Early election for Group 1, Phase II boilers. 76.8 Section 76.8 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) ACID RAIN NITROGEN OXIDES EMISSION REDUCTION PROGRAM § 76.8 Early election for Group 1...

  17. Cerebral near infrared spectroscopy oximetry in extremely preterm infants : Phase II randomised clinical trial

    NARCIS (Netherlands)

    Hyttel-Sorensen, Simon; Pellicer, Adelina; Alderliesten, Thomas; Austin, Topun; Van Bel, Frank; Benders, Manon; Claris, Olivier; Dempsey, Eugene; Franz, Axel R.; Fumagalli, Monica; Gluud, Christian; Grevstad, Berit; Hagmann, Cornelia; Lemmers, Petra; Van Oeveren, Wim; Pichler, Gerhard; Plomgaard, Anne Mette; Riera, Joan; Sanchez, Laura; Winkel, Per; Wolf, Martin; Greisen, Gorm

    2015-01-01

    Objective: To determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy (NIRS) oximetry. Design: Phase II randomised, single blinded, parallel clinical trial. Setting Eight tertiary neonatal intensive care units in

  18. Enzalutamide monotherapy: Phase II study results in patients with hormone-naive prostate cancer

    DEFF Research Database (Denmark)

    Tombal, Bertrand; Borre, Michael; Rathenborg, Per Zier

    2013-01-01

    al, N Engl J Med 2012;367:1187). Compared with bicalutamide in nonclinical studies, enzalutamide had higher androgen receptor– binding affinity, prevented nuclear translocation, showed no DNA binding, and induced apoptosis (Tran et al, Science 2009;324:787). In contrast to previous phase II and III...

  19. Gefitinib plus cisplatin and radiotherapy in previously untreated head and neck squamous cell carcinoma: A phase II, randomized, double-blind, placebo-controlled study

    International Nuclear Information System (INIS)

    Gregoire, Vincent; Hamoir, Marc; Chen Changhu; Kane, Madeleine; Kawecki, Andrzej; Julka, Pramod K.; Wang, Hung-Ming; Prasad, Srihari; D'Cruz, Anil K.; Radosevic-Jelic, Ljiljana; Kumar, Rejnish R.; Korzeniowski, Stanislaw; Fijuth, Jacek; Machiels, Jean-Pascal; Sellers, Mark V.; Tchakov, Ilian; Raben, David

    2011-01-01

    Background and purpose: To assess the efficacy and safety of gefitinib given concomitantly and/or as maintenance therapy to standard cisplatin/radiotherapy for previously untreated, unresected, stage III/IV non-metastatic SCCHN. Materials and methods: In this phase II, double-blind, study, 226 patients were randomized to gefitinib 250 mg/day, 500 mg/day or placebo in two phases: a concomitant phase (gefitinib or placebo with chemoradiotherapy), followed by a maintenance phase (gefitinib or placebo alone). Primary endpoint was local disease control rate (LDCR) at 2 years; secondary endpoints were LDCR at 1 year, objective response rate, progression-free survival, overall survival, and safety and tolerability. Results: Gefitinib (250 and 500 mg/day) did not improve 2-year LDCR compared with placebo either when given concomitantly with chemoradiotherapy (32.7% vs. 33.6%, respectively; OR 0.921, 95% CI 0.508, 1.670 [1-sided p = 0.607]) or as maintenance therapy (28.8% vs. 37.4%, respectively; OR 0.684, 95% CI 0.377, 1.241 [1-sided p = 0.894]). Secondary efficacy outcomes were broadly consistent with the 2-year LDCR results. In both doses, gefitinib was well-tolerated and did not adversely affect the safety and tolerability of concomitant chemoradiotherapy. Conclusion: Gefitinib was well-tolerated, but did not improve efficacy compared with placebo when given concomitantly with chemoradiotherapy, or as maintenance therapy alone.

  20. Resource Use and Costs of Dengue: Analysis of Data from Phase III Efficacy Studies of a Tetravalent Dengue Vaccine.

    Science.gov (United States)

    El Fezzazi, Hanna; Branchu, Marie; Carrasquilla, Gabriel; Pitisuttithum, Punnee; Perroud, Ana Paula; Frago, Carina; Coudeville, Laurent

    2017-12-01

    A tetravalent dengue vaccine (CYD-TDV) has recently been approved in 12 countries in southeast Asia and Latin America for individuals aged 9-45 years or 9-60 years (age indication approvals vary by country) living in endemic areas. Data on utilization of medical and nonmedical resources as well as time lost from school and work were collected during the active phase of two phase III efficacy studies performed in 10 countries in the Asia-Pacific region and Latin America (NCT01373281; NCT01374516). We compared dengue-related resource utilization and costs among vaccinated and nonvaccinated participants. Country-specific unit costs were derived from available literature. There were 901 virologically confirmed dengue episodes among participants aged ≥ 9 years ( N = 25,826): corresponding to 373 episodes in the CYD-TDV group ( N = 17,230) and 528 episodes in the control group ( N = 8,596). Fewer episodes in the CYD-TDV group resulted in hospitalization than in the control group (7.0% versus 13.3%; P = 0.002), but both had a similar average length of stay of 4 days. Overall, a two-thirds reduction in resource consumption and missed school/work days was observed in the CYD-TDV group relative to the control group. The estimated direct and indirect cost (2014 I$) associated with dengue episodes per participant in the CYD-TDV group was 73% lower than in the control group (I$6.72 versus I$25.08); representing a saving of I$I8.36 (95% confidence interval [CI]:17.05-19.78) per participant with vaccination. This is the first study providing information on dengue costs among vaccinated individuals and direct confirmation that vaccination has the potential to reduce dengue illness costs.

  1. Gemcitabine and irinotecan as first-line therapy for carcinoma of unknown primary: results of a multicenter phase II trial.

    Directory of Open Access Journals (Sweden)

    Shernan G Holtan

    Full Text Available Metastatic carcinoma of unknown primary (CUP has a very poor prognosis, and no standard first-line therapy currently exists. Here, we report the results of a phase II study utilizing a combination of gemcitabine and irinotecan as first-line therapy. Treatment was with gemcitabine 1000 mg/m(2 and irinotecan 75 mg/m(2 weekly times four on a six week cycle (Cohort I. Due to excessive toxicity, the dose and schedule were modified as follows: gemcitabine 750 mg/m(2 and irinotecan 75 mg/m(2 given weekly times three on a four week cycle (Cohort II. The primary endpoint was the confirmed response rate (CR + PR. Secondary endpoints consisted of adverse events based upon the presence or absence of the UDP glucuronosyltransferase 1 family, polypeptide A1*28 (UGT1A1*28 polymorphism, time to progression, and overall survival. Thirty-one patients were enrolled with a median age of 63 (range: 38-94, and 26 patients were evaluable for efficacy. Significant toxicity was observed in Cohort 1, characterized by 50% (7/14 patients experiencing a grade 4+ adverse event, but not in cohort II. The confirmed response rate including patients from both cohorts was 12% (95% CI: 2-30%, which did not meet the criteria for continued enrollment. Overall median survival was 7.2 months (95% CI: 4.0 to 11.6 for the entire cohort but notably longer in cohort II than in cohort I (9.3 months (95% CI: 4.1 to 12.1 versus 4.0 months (95% CI: 2.2 to 15.6. Gemcitabine and irinotecan is not an active combination when used as first line therapy in patients with metastatic carcinoma of unknown primary. Efforts into developing novel diagnostic and therapeutic approaches remain important for improving the outlook for this heterogeneous group of patients.ClinicalTrials.gov NCT00066781.

  2. Development and Validation of Methodology to Model Flow in Ventilation Systems Commonly Found in Nuclear Facilities - Phase II

    Energy Technology Data Exchange (ETDEWEB)

    Strons, Philip [Argonne National Lab. (ANL), Argonne, IL (United States); Bailey, James L. [Argonne National Lab. (ANL), Argonne, IL (United States); Davis, John [Argonne National Lab. (ANL), Argonne, IL (United States); Grudzinski, James [Argonne National Lab. (ANL), Argonne, IL (United States); Hlotke, John [Argonne National Lab. (ANL), Argonne, IL (United States)

    2016-03-01

    In this report we present the results of the Phase II analysis and testing of the flow patterns encountered in the Alpha Gamma Hot Cell Facility (AGHCF), as well as the results from an opportunity to expand upon field test work from Phase I by the use of a Class IIIb laser. The addition to the Phase I work is covered before proceeding to the results of the Phase II work, followed by a summary of findings.

  3. Phase I and II feasibility study report for the 300-FF-5 operable unit

    Energy Technology Data Exchange (ETDEWEB)

    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 Phase 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.

  4. Phase I and II feasibility study report for the 300-FF-5 operable unit

    International Nuclear Information System (INIS)

    1993-01-01

    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 Phase 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

  5. Radiation therapy for ocular choroidal neovascularization (phase I/II study): preliminary report

    International Nuclear Information System (INIS)

    Sasai, Keisuke; Murata, Rumi; Mandai, Michiko; Takahashi, Masayo; Ogura, Yuichiro; Ngata, Yasushi; Nishimura, Yasumasa; Hiraoka, Masahiro

    1997-01-01

    Purpose/Objective: Choroidal neovascularization (CNV) is a major cause of severe loss of visual acuity in some ocular diseases such as age-related macular degeneration (ARMD) and angioid streaks. Laser photocoagulation has been used to treat patients with subfoveal neovascular lesions with well-demarcated boundaries. However, the treatment method is usually associated with a large decrease in visual acuity. Therefore, indications for this treatment are very limited. Recently, some investigators reported the effect of low dose irradiation on the sub retinal neovascular membranes in CNV. We conducted a Phase I/II study to determine the toxicity and efficacy of external photon beam radiotherapy in patients with CNV. Methods and Materials: Between April, 1994 and July, 1995, 36 patients with choroidal neovascularization (34 with ARMD and 2 with angioid streaks) were treated with radiation therapy. Treatment planning was performed using a CT simulator that enables real-time treatment planning from multiple CT slices. The clinical target volume that included the macula and optic disc received a dose of 10 Gy/5 fractions/1 week (first 18 eyes) or 20 Gy/10 fractions/2 weeks (last 18 eyes). All eyes were irradiated with a single lateral 6 MV photon beam, angled 10 degrees posteriorly to exclude the ipsilateral lens and the contralateral eye from the radiation field. The ipsilateral lens was irradiated with less than 10% of the total reference dose. The field size averaged 3.0 x 2.5 cm. Records of the 17 eyes with CNV referred to our hospital in 1993, which satisfied the eligibility criteria for this study, were retrospectively analyzed for comparison. Results: There was no significant acute morbidity. All patients were followed regularly by both ophthalmologists and radiation oncologists. Cataract formation after 1 year of the treatment was observed in one patient who had received a dose of 20 Gy. One patient who had received 20 Gy complained of transient dry-eye sensation

  6. Nimotuzumab combined with radiotherapy for esophageal cancer: preliminary study of a Phase II clinical trial

    Directory of Open Access Journals (Sweden)

    Liang J

    2013-11-01

    Full Text Available Jun Liang,1 Mingyan E,2 Gang Wu,3 Lujun Zhao,4 Xia Li,5 Xia Xiu,6 Ning Li,1 Bo Chen,1 Zhouguang Hui,1 Jima Lv,1 Hui Fang,1 Yu Tang,1 Nan Bi,1 Wenqing Wang,1 Yirui Zhai,1 Tao Li,1 Dongfu Chen,1 Shuangmei Zou,7 Ning Lu,7 Rolando Perez-Rodríguez,8 Junqi Zheng,9 Luhua Wang11Department of Radiotherapy, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China; 2Department of Radiotherapy, Cancer Hospital of Harbin Medical University, Harbin, People's Republic of China; 3Department of Radiotherapy, Tongji Cancer Center Hospital, Wuhan, People's Republic of China; 4Department of Radiotherapy, Cancer Hospital of Tianjin Medical University, Tianjin, People's Republic of China; 5Department of Radiotherapy, LiaoNing Province Cancer Hospital, Shenyang, People's Republic of China; 6Department of Radiotherapy, Beijing Hospital, Beijing, People's Republic of China; 7Department of Pathology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China; 8Center of Molecular Immunology, Havana, Cuba; 9School of Medicine, Tongji University, Shanghai, People's Republic of ChinaObjective: To determine the safety and therapeutic effects of nimotuzumab (h-R3 combined with radiotherapy in esophageal cancer.Methods: This Phase II clinical trial involved 42 patients with stage II (inoperable or refused surgery to stage IV (supraclavicular lymph node metastasis only esophageal cancers treated between November 2008 and July 2010. All patients had squamous cell carcinomas, and all received three-dimensional conformal radiotherapy and 200 mg nimotuzumab per week during radiotherapy.Results: There were 9, 25, and 8 patients with stage II, III and IV disease, respectively. All except two patients received 50–70 Gy radiation; 37 patients (88.1% received more than five nimotuzumab doses. Grade III toxicities (21.4% of all adverse events included esophagitis and gastrointestinal, dermatological and hematological

  7. Phase II Upgrade of the GERDA Experiment for the Search of Neutrinoless Double Beta Decay

    Science.gov (United States)

    Majorovits, B.

    Observation of neutrinoless double beta decay could answer the question regarding the Majorana or Dirac nature of neutrinos. The GERDA experiment utilizes HPGe detectors enriched with the isotope 76Ge to search for this process. Recently the GERDA collaboration has unblinded data of Phase I of the experiment. In order to further improve the sensitivity of the experiment, additionally to the coaxial detectors used, 30 BEGe detectors made from germanium enriched in 76Ge will be deployed in GERDA Phase II. BEGe detectors have superior PSD capability, thus the background can be further reduced. The liquid argon surrounding the detector array will be instrumented in order to reject background by detecting scintillation light induced in the liquid argon by radiation. After a short introduction the hardware preparations for GERDA Phase II as well as the processing and characterization of the 30 BEGe detectors are discussed.

  8. Phased Retrofits in Existing Homes in Florida Phase II. Shallow Plus Retrofits

    Energy Technology Data Exchange (ETDEWEB)

    Sutherland, K. [Building America Partnership for Improved Residential Construction, Cocoa, FL (United States); Parker, D. [Building America Partnership for Improved Residential Construction, Cocoa, FL (United States); Martin, E. [Building America Partnership for Improved Residential Construction, Cocoa, FL (United States); Chasar, D. [Building America Partnership for Improved Residential Construction, Cocoa, FL (United States); Amos, B. [Building America Partnership for Improved Residential Construction, Cocoa, FL (United States)

    2016-02-01

    The BAPIRC team and Florida Power and Light (FPL) electric utility pursued a pilot phased energy-efficiency retrofit program in Florida by creating detailed data on the energy and economic performance of two levels of retrofit - simple and deep. For this Phased Deep Retrofit (PDR) project, a total of 56 homes spread across the utility partner's territory in east central Florida, southeast Florida, and southwest Florida were instrumented between August 2012 and January 2013, and received simple pass-through retrofit measures during the period of March 2013 - June 2013. Ten of these homes received a deeper package of retrofits during August 2013 - December 2013.

  9. Medical information, communication, and archiving system (MICAS): Phase II integration and acceptance testing

    Science.gov (United States)

    Smith, Edward M.; Wandtke, John; Robinson, Arvin E.

    1999-07-01

    The Medical Information, Communication and Archive System (MICAS) is a multi-modality integrated image management system that is seamlessly integrated with the Radiology Information System (RIS). This project was initiated in the summer of 1995 with the first phase being installed during the first half of 1997 and the second phase installed during the summer of 1998. Phase II enhancements include a permanent archive, automated workflow including modality worklist, study caches, NT diagnostic workstations with all components adhering to Digital Imaging and Communications in Medicine (DICOM) standards. This multi-vendor phased approach to PACS implementation is designed as an enterprise-wide PACS to provide images and reports throughout our healthcare network. MICAS demonstrates that aa multi-vendor open system phased approach to PACS is feasible, cost-effective, and has significant advantages over a single vendor implementation.

  10. Fluorouracil and high-dose leucovorin with radiotherapy as adjuvant therapy for rectal cancer. Results of a phase II study

    Energy Technology Data Exchange (ETDEWEB)

    Giralt, J. [Radiation Oncology Service, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Rubio, D. [Medical Oncology Service, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Maldonado, X. [Radiation Oncology Service, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Naval, J. [Dept. of Surgery, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Casado, S. [Medical Oncology Service, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Lara, F. [Dept. of Surgery, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Rosello, J.M. [Dept. of Preventive Medicine, Hospital General Universitari Vall d`Hebron, Barcelona (Spain); Armengol, M. [Dept. of Surgery, Hospital General Universitari Vall d`Hebron, Barcelona (Spain)

    1997-07-01

    The purpose of this phase II study was to evaluate the efficacy and toxicity of fluorouracil and high-dose leucovorin (5-FU/LV) with pelvic irradiation as adjuvant therapy for patients with macroscopical resected rectal or recto-sigmoid cancer. Following surgery for stages II-III primary (52) or recurrent rectal cancer (4), 56 patients received 8 cycles of 5-FU/LV and pelvic irradiation. 5-FU doses were 200 mgr/m{sup 2} for cycles 2-3 and 300 mgr/m{sup 2} for cycles 1 and 4-8. LV doses remained fixed at 200 mgr/m{sup 2}. Pelvic radiation was started in the third week, between the first and second cycle. The total dose was 50.4 Gy. No serve complications had been recorded. The incidence of grade 3 diarrhea was 19%. Three patients presented leukopenia grade 3 (5%). In 44 patients (78%) the planned treatment could be administered. The median follow-up was 40 months (range 22-66). Seven patients had a local relapse (13%) and 6 developed distant metastasis (10%). The 3-year disease-free survival was 72% and the overall survival was 76%. These preliminary results show that combined post-operative 5-FU/LV and pelvic radiotherapy are well tolerated and present a reasonable local control and survival rates. This adjuvant treatment should be evaluated in randomized trials. (orig.).

  11. Phase I/II Study of Radiofrequency Ablation for Malignant Renal Tumors: Japan Interventional Radiology in Oncology Study Group 0701

    Energy Technology Data Exchange (ETDEWEB)

    Mimura, Hidefumi, E-mail: mimura@marianna-u.ac.jp [St. Marianna University School of Medicine, Department of Radiology (Japan); Arai, Yasuaki, E-mail: arai-y3111@mvh.biglobe.ne.jp [National Cancer Center Hospital, Department of Diagnostic Radiology (Japan); Yamakado, Koichiro, E-mail: yama@clin.medic.mie-u.ac.jp [Mie University School of Medicine, Department of Interventional Radiology (Japan); Sone, Miyuki, E-mail: msone@me.com; Takeuchi, Yoshito, E-mail: yotake62@qg8.so-net.ne.jp [National Cancer Center Hospital, Department of Diagnostic Radiology (Japan); Miki, Tsuneharu, E-mail: tmiki@koto.kpu-m.ac.jp [Kyoto Prefectural University of Medicine, Department of Urology (Japan); Gobara, Hideo, E-mail: gobara@cc.okayama-u.ac.jp [Okayama University Medical School, Department of Radiology (Japan); Sakuhara, Yusuke, E-mail: yusaku@med.hokudai.ac.jp [Hokkaido University School of Medicine, Department of Diagnostic and Interventional Radiology (Japan); Yamamoto, Takanobu, E-mail: tyamamot@tcc.pref.tochigi.lg.jp [Tochigi Cancer Center, Department of Radiology (Japan); Sato, Yozo, E-mail: ysato@aichi-cc.jp [Aichi Cancer Center Hospital, Department of Diagnostic and Interventional Radiology (Japan); Kanazawa, Susumu, E-mail: susumu@cc.okayama-u.ac.jp [Okayama University Medical School, Department of Radiology (Japan)

    2016-05-15

    PurposeThis multicenter phase I/II study evaluated the safety, feasibility, and initial efficacy of radiofrequency ablation (RFA) for small malignant renal tumors.MethodsThirty-three patients were enrolled in the study. A single session of RFA was performed in patients with a renal tumor of 1–3 cm in greatest diameter, with the exception of lesions adjacent to the renal hilum. The primary endpoint was the safety of renal RFA, and the secondary endpoints were its feasibility and initial efficacy for local control, as well as the incidence and grade of adverse events. Clinical efficacy was evaluated by CT scans within 1 week and at a further 4 weeks after the procedure using the criteria adapted from the Response Evaluation Criteria in Solid Tumors.ResultsThe RFA procedure was completed in 100 % (95 % confidence interval [CI] 89–100 %) of all 33 patients. There were no severe adverse events (0 % [95 % CI 0–11 %]). Among the 33 patients, a complete response, partial response, progressive disease, and stable disease were seen in 28 (85 %), 0 (0 %), one (3 %), and one (3 %) patient(s), respectively, with a tumor response rate of 85 % [95 % CI 68–95 %]). Three patients (9 %), including one ineligible patient (3 %), were not evaluable. Out of 30 evaluable patients, a complete response was achieved in 28 (93 %).ConclusionThe current multicenter trial revealed that RFA is a safe, feasible, and effective treatment for small malignant renal tumors in patients who are not candidates for surgery.

  12. Phase I/II Study of Radiofrequency Ablation for Malignant Renal Tumors: Japan Interventional Radiology in Oncology Study Group 0701

    International Nuclear Information System (INIS)

    Mimura, Hidefumi; Arai, Yasuaki; Yamakado, Koichiro; Sone, Miyuki; Takeuchi, Yoshito; Miki, Tsuneharu; Gobara, Hideo; Sakuhara, Yusuke; Yamamoto, Takanobu; Sato, Yozo; Kanazawa, Susumu

    2016-01-01

    PurposeThis multicenter phase I/II study evaluated the safety, feasibility, and initial efficacy of radiofrequency ablation (RFA) for small malignant renal tumors.MethodsThirty-three patients were enrolled in the study. A single session of RFA was performed in patients with a renal tumor of 1–3 cm in greatest diameter, with the exception of lesions adjacent to the renal hilum. The primary endpoint was the safety of renal RFA, and the secondary endpoints were its feasibility and initial efficacy for local control, as well as the incidence and grade of adverse events. Clinical efficacy was evaluated by CT scans within 1 week and at a further 4 weeks after the procedure using the criteria adapted from the Response Evaluation Criteria in Solid Tumors.ResultsThe RFA procedure was completed in 100 % (95 % confidence interval [CI] 89–100 %) of all 33 patients. There were no severe adverse events (0 % [95 % CI 0–11 %]). Among the 33 patients, a complete response, partial response, progressive disease, and stable disease were seen in 28 (85 %), 0 (0 %), one (3 %), and one (3 %) patient(s), respectively, with a tumor response rate of 85 % [95 % CI 68–95 %]). Three patients (9 %), including one ineligible patient (3 %), were not evaluable. Out of 30 evaluable patients, a complete response was achieved in 28 (93 %).ConclusionThe current multicenter trial revealed that RFA is a safe, feasible, and effective treatment for small malignant renal tumors in patients who are not candidates for surgery.

  13. Tofacitinib in patients with ankylosing spondylitis: a phase II, 16-week, randomised, placebo-controlled, dose-ranging study.

    Science.gov (United States)

    van der Heijde, Désirée; Deodhar, Atul; Wei, James C; Drescher, Edit; Fleishaker, Dona; Hendrikx, Thijs; Li, David; Menon, Sujatha; Kanik, Keith S

    2017-08-01

    To compare efficacy and safety of various doses of tofacitinib, an oral Janus kinase inhibitor, with placebo in patients with active ankylosing spondylitis (AS, radiographic axial spondyloarthritis). In this 16-week (12-week treatment, 4-week washout), phase II, multicentre, dose-ranging trial, adult patients with active AS were randomised (N=51, 52, 52, 52, respectively) to placebo or tofacitinib 2, 5 or 10 mg twice daily. The primary efficacy endpoint was Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response rate at week 12. Secondary endpoints included objective measures of disease activity, patient-reported outcomes and MRI of sacroiliac joints and spine. Safety was monitored. Emax model analysis of the primary endpoint predicted a tofacitinib 10 mg twice daily ASAS20 response rate of 67.4%, 27.3% higher than placebo. Supportive normal approximation analysis demonstrated tofacitinib 5 mg twice daily ASAS20 response rate significantly higher than placebo (80.8% vs 41.2%; ptofacitinib 2 and 10 mg twice daily demonstrated greater response rate than placebo (51.9% and 55.8%, respectively; not significant). Secondary endpoints generally demonstrated greater improvements with tofacitinib 5 and 10 mg twice daily than placebo. Objective (including MRI) endpoints demonstrated clear dose response. Adverse events were similar across treatment groups with no unexpected safety findings. Dose-dependent laboratory outcome changes returned close to baseline by week 16. Tofacitinib 5 and 10 mg twice daily demonstrated greater clinical efficacy versus placebo in reducing signs, symptoms and objective endpoints of active AS in adult patients with a similar 12-week safety profile as reported in other indications. NCT01786668. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

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

    Science.gov (United States)

    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…

  15. A Phase II dose titration study of thalidomide for cancer-associated anorexia.

    Science.gov (United States)

    Davis, Mellar; Lasheen, Wael; Walsh, Declan; Mahmoud, Fade; Bicanovsky, Leslie; Lagman, Ruth

    2012-01-01

    Sixty-five percent of people with advanced cancer suffers from loss of appetite. Several inflammatory cytokines appear to cause appetite loss in animal models. Thalidomide is an immunomodulatory drug that has been associated with improved appetite in those with HIV infections and cancer. We completed a two-stage Phase II dose titration study of thalidomide, the primary purpose of which was to assess appetite response to thalidomide in cancer-associated anorexia. Individuals older than 18 years of age with active cancer, loss of appetite by numerical rating scale (NRS), life expectancy of at least four weeks, and Eastern Cooperative Oncology Group performance status of 0-3 were entered into the study. Pretreatment screening included medical history, neurologic examination, and symptoms by NRS and categorical scale (CAT). Patients received 50mg of thalidomide by mouth at bedtime for two weeks. Individuals who did not respond were dose escalated to 100mg at night for two weeks. Assessment of appetite, early satiety, fatigue, insomnia, night sweats, pain, and quality of life (QOL) occurred at two-week intervals. Toxicity also was assessed. The primary outcome was appetite response defined as a two-point reduction in the NRS or a one-point improvement in the CAT. Thirty-five patients entered the study; 33 completed 14 days of therapy and were analyzed for efficacy and toxicity. Sixty-four percent who completed at least two weeks of thalidomide had improved appetite. The CAT scores for appetite, insomnia, and QOL improved significantly. The 95% confidence intervals did not overlap. Five participants dropped out because of toxicity: two before two weeks and three later. Thalidomide reduced multiple symptoms commonly associated with cancer-related anorexia and improved QOL. Our findings confirmed and validated a previously published single-arm trial. A recent randomized trial demonstrated greater benefits when thalidomide is used combined with other agents to treat cancer

  16. Phase-II Clinical Validation of a Powered Exoskeleton for the Treatment of Elbow Spasticity.

    Science.gov (United States)

    Crea, Simona; Cempini, Marco; Mazzoleni, Stefano; Carrozza, Maria Chiara; Posteraro, Federico; Vitiello, Nicola

    2017-01-01

    Introduction: Spasticity is a typical motor disorder in patients affected by stroke. Typically post-stroke rehabilitation consists of repetition of mobilization exercises on impaired limbs, aimed to reduce muscle hypertonia and mitigate spastic reflexes. It is currently strongly debated if the treatment's effectiveness improves with the timeliness of its adoption; in particular, starting intensive rehabilitation as close as possible to the stroke event may counteract the growth and postpone the onset of spasticity. In this paper we present a phase-II clinical validation of a robotic exoskeleton in treating subacute post-stroke patients. Methods: Seventeen post-stroke patients participated in 10 daily rehabilitation sessions using the NEUROExos Elbow Module exoskeleton, each one lasting 45 min: the exercises consisted of isokinetic passive mobilization of the elbow, with torque threshold to detect excessive user's resistance to the movement. We investigated the safety by reporting possible adverse events, such as mechanical, electrical or software failures of the device or injuries or pain experienced by the patient. As regards the efficacy , the Modified Ashworth Scale, was identified as primary outcome measure and the NEEM metrics describing elbow joint resistance to passive extension (i.e., maximum extension torque and zero-torque angle) as secondary outcomes. Results: During the entire duration of the treatments no failures or adverse events for the patients were reported. No statistically significant differences were found in the Modified Ashworth Scale scores, between pre-treatment and post-treatment and between post-treatment and follow-up sessions, indicating the absence of spasticity increase throughout (14 days) and after (3-4 months follow-up) the treatment. Exoskeleton metrics confirmed the absence of significant difference in between pre- and post-treatment data, whereas intra-session data highlighted significant differences in the secondary outcomes

  17. Phase-II Clinical Validation of a Powered Exoskeleton for the Treatment of Elbow Spasticity

    Directory of Open Access Journals (Sweden)

    Simona Crea

    2017-05-01

    Full Text Available Introduction: Spasticity is a typical motor disorder in patients affected by stroke. Typically post-stroke rehabilitation consists of repetition of mobilization exercises on impaired limbs, aimed to reduce muscle hypertonia and mitigate spastic reflexes. It is currently strongly debated if the treatment's effectiveness improves with the timeliness of its adoption; in particular, starting intensive rehabilitation as close as possible to the stroke event may counteract the growth and postpone the onset of spasticity. In this paper we present a phase-II clinical validation of a robotic exoskeleton in treating subacute post-stroke patients.Methods: Seventeen post-stroke patients participated in 10 daily rehabilitation sessions using the NEUROExos Elbow Module exoskeleton, each one lasting 45 min: the exercises consisted of isokinetic passive mobilization of the elbow, with torque threshold to detect excessive user's resistance to the movement. We investigated the safety by reporting possible adverse events, such as mechanical, electrical or software failures of the device or injuries or pain experienced by the patient. As regards the efficacy, the Modified Ashworth Scale, was identified as primary outcome measure and the NEEM metrics describing elbow joint resistance to passive extension (i.e., maximum extension torque and zero-torque angle as secondary outcomes.Results: During the entire duration of the treatments no failures or adverse events for the patients were reported. No statistically significant differences were found in the Modified Ashworth Scale scores, between pre-treatment and post-treatment and between post-treatment and follow-up sessions, indicating the absence of spasticity increase throughout (14 days and after (3–4 months follow-up the treatment. Exoskeleton metrics confirmed the absence of significant difference in between pre- and post-treatment data, whereas intra-session data highlighted significant differences in the

  18. Phase equilibrium measurements and the tuning behavior of new sII clathrate hydrates

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Woongchul; Park, Seongmin; Ro, Hyeyoon; Koh, Dong-Yeun; Seol, Jiwoong [Department of Chemical and Biomolecular Engineering (BK21 Program), KAIST, Daejeon 305-701 (Korea, Republic of); Lee, Huen, E-mail: h_lee@kaist.ac.kr [Department of Chemical and Biomolecular Engineering (BK21 Program), KAIST, Daejeon 305-701 (Korea, Republic of); Graduate School of EEWS, KAIST, Daejeon 305-701 (Korea, Republic of)

    2012-01-15

    Graphical abstract: Pyrrolidine and piperidine act as sII clathrate hydrate formers under methane gas. Highlights: > New sII clathrate hydrate formers were proposed: pyrrolidine and piperidine. > Formation of gas hydrate with methane as help gas was confirmed. > NMR, Raman, and XRD patterns were analyzed to identify the hydrate structures. > We measured (L + H + V) phase equilibrium with proposed hydrate formers. > Tuning phenomena increase gas storage in (pyrrolidine + CH{sub 4}) clathrate hydrates. - Abstract: We suggest two types of new amine-type sII formers: pyrrolidine and piperidine. These guest compounds fail to form clathrate hydrate structures with host water, but instead have to combine with light gaseous guest molecules (methane) for enclathration. First, two binary clathrate hydrates of (pyrrolidine + methane) and (piperidine + methane) were synthesized at various amine concentrations. {sup 13}C NMR and Raman analysis were done to identify the clathrate hydrate structure and guest distribution over sII-S and sII-L cages. XRD was also used to find the exact structure and corresponding cell parameters. At a dilute pyrrolidine concentration of less than 5.56 mol%, the tuning phenomenon is observed such that methane molecules surprisingly occupy sII-L cages. At the critical guest concentration of about 0.1 mol%, the cage occupancy ratio reaches the maximum of approximately 0.5. At very dilute guest concentration below 0.1 mol%, the methane molecules fail to occupy large cages on account of their rarefied distribution in the network. Direct-release experiments were performed to determine the actual guest compositions in the clathrate hydrate phases. Finally, we measured the clathrate hydrate phase equilibria of (pyrrolidine + methane) and (piperidine + methane).

  19. Phase equilibrium measurements and the tuning behavior of new sII clathrate hydrates

    International Nuclear Information System (INIS)

    Shin, Woongchul; Park, Seongmin; Ro, Hyeyoon; Koh, Dong-Yeun; Seol, Jiwoong; Lee, Huen

    2012-01-01

    Graphical abstract: Pyrrolidine and piperidine act as sII clathrate hydrate formers under methane gas. Highlights: → New sII clathrate hydrate formers were proposed: pyrrolidine and piperidine. → Formation of gas hydrate with methane as help gas was confirmed. → NMR, Raman, and XRD patterns were analyzed to identify the hydrate structures. → We measured (L + H + V) phase equilibrium with proposed hydrate formers. → Tuning phenomena increase gas storage in (pyrrolidine + CH 4 ) clathrate hydrates. - Abstract: We suggest two types of new amine-type sII formers: pyrrolidine and piperidine. These guest compounds fail to form clathrate hydrate structures with host water, but instead have to combine with light gaseous guest molecules (methane) for enclathration. First, two binary clathrate hydrates of (pyrrolidine + methane) and (piperidine + methane) were synthesized at various amine concentrations. 13 C NMR and Raman analysis were done to identify the clathrate hydrate structure and guest distribution over sII-S and sII-L cages. XRD was also used to find the exact structure and corresponding cell parameters. At a dilute pyrrolidine concentration of less than 5.56 mol%, the tuning phenomenon is observed such that methane molecules surprisingly occupy sII-L cages. At the critical guest concentration of about 0.1 mol%, the cage occupancy ratio reaches the maximum of approximately 0.5. At very dilute guest concentration below 0.1 mol%, the methane molecules fail to occupy large cages on account of their rarefied distribution in the network. Direct-release experiments were performed to determine the actual guest compositions in the clathrate hydrate phases. Finally, we measured the clathrate hydrate phase equilibria of (pyrrolidine + methane) and (piperidine + methane).

  20. Efficacy and safety of tofacitinib in patients with active rheumatoid arthritis: review of key Phase 2 studies.

    Science.gov (United States)

    Fleischmann, Roy; Kremer, Joel; Tanaka, Yoshiya; Gruben, David; Kanik, Keith; Koncz, Tamas; Krishnaswami, Sriram; Wallenstein, Gene; Wilkinson, Bethanie; Zwillich, Samuel H; Keystone, Edward

    2016-12-01

    Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here, the safety and efficacy data from five Phase 2 studies of tofacitinib in patients with RA are summarized. Tofacitinib 1-30 mg twice daily was investigated, as monotherapy and in combination with methotrexate, in patients with RA. Tofacitinib 20 mg once daily was investigated in one study. Tofacitinib 5 and 10 mg twice daily were selected for investigation in Phase 3 studies; therefore, the efficacy and safety of tofacitinib 5 and 10 mg twice daily in Phase 2 studies are the focus of this review. Tofacitinib ≥ 5 mg twice daily was efficacious in a dose-dependent manner, with statistically significant and clinically meaningful reductions in the signs and symptoms of RA and patient-reported outcomes. The safety profile was consistent across studies. The efficacy and safety profile of tofacitinib in Phase 2 studies supported its further investigation and the selection of tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily for evaluation in Phase 3 studies. © 2016 The Authors. International Journal of Rheumatic Diseases published by Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

  1. Effect of timing on the outcomes of 1-phase nonextraction therapy of Class II malocclusion.

    Science.gov (United States)

    Baccetti, Tiziano; Franchi, Lorenzo; Kim, Ludia H

    2009-10-01

    The aim of this cephalometric study was to evaluate the role of timing in relation to skeletal maturity on the outcomes of nonextraction comprehensive Class II therapy. Three samples of patients with Class II Division 1 malocclusion were treated with headgear combined with fixed appliances and Class II elastics. Lateral cephalograms were taken of all subjects before therapy (T1) and at an average interval of 6 months after therapy (T2). The first sample (23 subjects) was treated before the pubertal growth spurt, the second sample (24 subjects) received therapy during the pubertal growth spurt, and the third sample (13 subjects) was treated at a postpubertal stage of development. The average T1 to T2 interval was approximately 30 months for all patients, with an average treatment duration of 24 months. Longitudinal observations of a group of 17 subjects with untreated Class II malocclusions were compared with the treated groups at the 3 skeletal maturation intervals with nonparametric statistics. Class II treatment before or during the pubertal growth spurt induced significant favorable skeletal changes (restricted maxillary advancement in prepubertal patients and enhanced mandibular growth in pubertal patients). Patients treated after the pubertal growth spurt had only significant dentoalveolar changes. The greatest amount of dentoskeletal correction of Class II malocclusion with 1-phase nonextraction treatment occurred in patients treated during the pubertal growth spurt.

  2. Stimulated phase-shift acoustic nanodroplets enhance vancomycin efficacy against methicillin-resistant Staphylococcus aureus biofilms

    Directory of Open Access Journals (Sweden)

    Guo H

    2017-06-01

    Full Text Available Hao Guo,1 Ziming Wang,1 Quanyin Du,1 Pan Li,2 Zhigang Wang,2 Aimin Wang1 1Department of Orthopedics, Institute of Surgery Research, Daping Hospital, Third Military Medical University, Chongqing, China; 2Chongqing Key Laboratory of Ultrasound Molecular Imaging, Institute of Ultrasound Imaging, Second Affiliated Hospital of Chongqing Medical University, Chongqing, China Purpose: Bacterial biofilms on the surface of prostheses are becoming a rising concern in managing prosthetic joint infections. The inherent resistant features of biofilms render traditional antimicrobial therapy unproductive and revision surgery outcomes uncertain. This situation has prompted the exploration of novel antimicrobial strategies. The synergy of ultrasound microbubbles and vancomycin has been proposed as an efficient alternative for biofilm eradication. The purpose of this study was to evaluate the anti-biofilm effect of stimulated phase-shift acoustic nanodroplets (NDs combined with vancomycin.Materials and methods: We fabricated lipid phase-shift NDs with a core of liquid perfluoropentane. A new phase change mode for NDs incorporating an initial unfocused low-intensity pulsed ultrasound for 5 minutes and a subsequent incubation at 37°C into a 24-hour duration was developed. Methicillin-resistant Staphylococcus aureus (MRSA biofilms were incubated with vancomycin and NDs under the hybrid stimulation. Biofilm morphology following treatment was determined using confocal laser scanning microscopy and scanning electron microscopy. Resazurin assay was used to quantify bactericidal efficacy against MRSA biofilm bacteria.Results: NDs treated sequentially with ultrasound and heating at 37°C achieved gradual and substantial ND vaporization and cavitation in a successive process. NDs after stimulation were capable of generating stronger destruction on biofilm structure which was best characterized by residual circular arc margins and more dead bacteria. Furthermore, NDs

  3. Efficacy and safety of tofacitinib in patients with active rheumatoid arthritis: review of key Phase 2 studies

    OpenAIRE

    Fleischmann, Roy; Kremer, Joel; Tanaka, Yoshiya; Gruben, David; Kanik, Keith; Koncz, Tamas; Krishnaswami, Sriram; Wallenstein, Gene; Wilkinson, Bethanie; Zwillich, Samuel H.; Keystone, Edward

    2016-01-01

    Abstract Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Here, the safety and efficacy data from five Phase 2 studies of tofacitinib in patients with RA are summarized. Tofacitinib 1?30 mg twice daily was investigated, as monotherapy and in combination with methotrexate, in patients with RA. Tofacitinib 20 mg once daily was investigated in one study. Tofacitinib 5 and 10 mg twice daily were selected for investigation in Phase 3 studies; therefore,...

  4. [Relationship between HLA-DRB1 genotypes and efficacy of oral type II collagen treatment using chicken cartilage soup in rheumatoid arthritis].

    Science.gov (United States)

    Toda, Y; Takemura, S; Morimoto, T; Ogawa, R

    1997-02-01

    The correlation between the efficacy of type II collagen (C II) treatment of the rheumatoid arthritis (RA) and the existence of HLA-DRB 1 * 0405 allele was investigated in two groups of patients; the first group had HLA-DRB 1 * 0405 allele (the 0405 group) and the second had no such allele (the non-0405 group). Thirty-eight RA patients were given a chicken cartilage soup containing heat degenerated C II (the CII group) or a placebo soup (the placebo group) for three months. The 38 cases were composed of 11 cases in the 0405/C II group, 9 in the 0405/placebo group, 11 in the non-0405/C II group, 9 cases in the non-0405/placebo group. In the C II group, there was a significant increase in the anti-human C II IgA antibody serum titers (p = 0.003) and significant decrease in the anti-human C II IgG titer (p II and 0405/placebo groups (p of the swollen joints = 0.03, and p of the tender joints = 0.03), and between the 0405/C II and non-0405/C II groups (p = 0.006 and 0.01, respectively). We concluded that oral C II could have a therapeutic efficacy in RA patients with HLA-DRB 1 * 0405 allele.

  5. Intravitreal sirolimus for the treatment of geographic atrophy: results of a phase I/II clinical trial.

    Science.gov (United States)

    Petrou, Philip A; Cunningham, Denise; Shimel, Katherine; Harrington, Molly; Hammel, Keri; Cukras, Catherine A; Ferris, Frederick L; Chew, Emily Y; Wong, Wai T

    2014-12-18

    To investigate the safety and effects of intravitreal sirolimus for the potential treatment of geographic atrophy (GA). The study was a single-center, open-label, phase I/II trial enrolling six participants with bilateral GA treated with intravitreal sirolimus in only one randomly assigned eye, with the fellow eye as control. The primary efficacy outcome measure was the change in total GA area from baseline on color fundus photography (CFP); secondary outcomes included changes in GA area on fundus autofluorescence (FAF), visual acuity, central retinal thickness (CRT), and macular sensitivity from baseline. Although no systemic adverse events were attributed to treatment, two of six participants had ocular adverse events that were possibly associated. The treated eye of one participant developed abnormal paralesional changes on FAF that were associated with accelerated retinal thinning. This accelerated retinal thinning was also seen in the treated eye of a second participant. Because of concern that these events were associated with treatment, treatment was suspended. Comparisons of treated and fellow eyes for change in visual acuity, change in GA area, and change in CRT showed no evidence of treatment benefit and generally favored the untreated fellow eye. While paralesional FAF changes and rapid retinal thinning observed are potentially part of the natural course of GA, they may possibly be related to treatment. No general evidence of anatomical or functional benefit was detected in treated eyes. Further data on intravitreal sirolimus for GA treatment will be available from a larger phase II trial. (ClinicalTrials.gov number, NCT01445548.). Copyright 2015 The Association for Research in Vision and Ophthalmology, Inc.

  6. Phase transitions in solid Kr-CH4 solutions and rotational excitations in phase II

    International Nuclear Information System (INIS)

    Bagatskii, M.I.; Mashchenko, D.A.; Dudkin, V.V.

    2007-01-01

    The heat capacity C p of solid Kr-n CH 4 solutions with the CH 4 concentrations n=0.82, 0.86, 0.90 as well as solutions with n=0.90, 0.95 doped with 0.002 O 2 impurity has been investigated under equilibrium vapor pressure over the internal 1-24 K. The (T,n)-phase diagram was refined and the region of two-phase states was determined for Kr-n CH 4 solid solutions. The contribution of the rotational subsystem, C r ot, to the heat capacity of the solutions has been separated. Analysis of C r ot(T) at T 1 and E 2 between the tunnel levels of the A-, T- and A-, E--nuclear-spin species of CH 4 molecules in the orientationally ordered subsystem, and to determine the effective energy gaps E 1 between lowest levels of the A- and T- species. The relations τ(n) and E 1 (n) stem from changes of the effective potential field caused as the replacement of CH 4 molecules by Kr atoms at sites of the ordered sublattices. The effective gaps E L between a group of tunnel levels of the ground-state liberation state and the nearest group of excited levels of the liberation state of the ordered CH 4 molecules in the solutions with n=0.90 (E L =52 K) and 0.95 (E L =55 K) has been estimated

  7. Enginnering development of coal-fired high performance power systems phase II and III

    International Nuclear Information System (INIS)

    1998-01-01

    This report presents work carried out under contract DE-AC22-95PC95144 ''Engineering Development of Coal-Fired High Performance Systems Phase II and III.'' The goals of the program are to develop a coal-fired high performance power generation system (HIPPS) that is capable of: thermal efficiency (HHV) >47%; NOx, SOx, and particulates 65% of heat input; all solid wastes benign; cost of electricity <90% of present plants. Phase I, which began in 1992, focused on the analysis of various configurations of indirectly fired cycles and on technical assessments of alternative plant subsystems and components, including performance requirements, developmental status, design options, complexity and reliability, and capital and operating costs. Phase I also included preliminary R ampersand D and the preparation of designs for HIPPS commercial plants approximately 300 MWe in size. This phase, Phase II, involves the development and testing of plant subsystems, refinement and updating of the HIPPS commercial plant design, and the site selection and engineering design of a HIPPS prototype plant. Work reported herein is from: Task 2.2 HITAF Air Heaters; Task 6 HIPPS Commercial Plant Design Update

  8. 200-ZP-1 phase II and III IRM groundwater pump and treat site safety plan

    International Nuclear Information System (INIS)

    St. John, C.H.

    1996-07-01

    This safety plan covers operations, maintenance, and support activities related to the 200-ZP-1 Phase II and III Ground Water Pump- and-Treat Facility. The purpose of the facility is to extract carbon tetrachloride contaminated groundwater underlying the ZP-1 Operable Unit; separate the contaminant from the groundwater; and reintroduce the treated water to the aquifer. An air stripping methodology is employed to convert volatile organics to a vapor phase for absorption onto granular activated carbon. The automated process incorporates a variety of process and safety features that shut down the process system in the event that process or safety parameters are exceeded or compromised

  9. Rigid Polyurethane Foam (RPF) Technology for Countermines (Sea) Program Phase II

    Energy Technology Data Exchange (ETDEWEB)

    WOODFIN,RONALD L.; FAUCETT,DAVID L.; HANCE,BRADLEY G.; LATHAM,AMY E.; SCHMIDT,C.O.

    1999-10-01

    This Phase II report documents the results of one subtask initiated under the joint Department of Energy (DOE)/Department of Defense (DoD) Memorandum of Understanding (MOU) for Countermine Warfare. The development of Rigid Polyurethane Foams for neutralization of mines and barriers in amphibious assault was the objective of the tasking. This phase of the program concentrated on formation of RPF in water, explosive mine simulations, and development of foam and fabric pontoons. Field experimentation was done primarily at the Energetic Materials Research and Testing Center (EMRTC) of the New Mexico Institute of Mining and Technology, Socorro, NM between February 1996 and September 1998.

  10. Free-Piston Stirling Power Conversion Unit for Fission Power System, Phase II Final Report

    Science.gov (United States)

    Wood, J. Gary; Stanley, John

    2016-01-01

    In Phase II, the manufacture and testing of two 6-kW(sub e)Stirling engines was completed. The engines were delivered in an opposed 12-kW(sub e) arrangement with a common expansion space heater head. As described in the Phase I report, the engines were designed to be sealed both hermetically and with a bolted O-ring seal. The completed Phase II convertor is in the bolted configuration to allow future disassembly. By the end of Phase II, the convertor had passed all of the final testing requirements in preparation for delivery to the NASA Glenn Research Center. The electronic controller also was fabricated and tested during Phase II. The controller sets both piston amplitudes and maintains the phasing between them. It also sets the operating frequency of the machine. Details of the controller are described in the Phase I final report. Fabrication of the direct-current to direct-current (DC-DC) output stage, which would have stepped down the main controller output voltage from 700 to 120 V(sub DC), was omitted from this phase of the project for budgetary reasons. However, the main controller was successfully built, tested with the engines, and delivered. We experienced very few development issues with this high-power controller. The project extended significantly longer than originally planned because of yearly funding delays. The team also experienced several hardware difficulties along the development path. Most of these were related to the different thermal expansions of adjacent parts constructed of different materials. This issue was made worse by the large size of the machine. Thermal expansion problems also caused difficulties in the brazing of the opposed stainless steel sodium-potassium (NaK) heater head. Despite repeated attempts Sunpower was not able to successfully braze the opposed head under this project. Near the end of the project, Glenn fabricated an opposed Inconel NaK head, which was installed prior to delivery for testing at Glenn. Engine

  11. A phase I/II trial of hydroxychloroquine in conjunction with radiation therapy and concurrent and adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme.

    Science.gov (United States)

    Rosenfeld, Myrna R; Ye, Xiaobu; Supko, Jeffrey G; Desideri, Serena; Grossman, Stuart A; Brem, Steven; Mikkelson, Tom; Wang, Daniel; Chang, Yunyoung C; Hu, Janice; McAfee, Quentin; Fisher, Joy; Troxel, Andrea B; Piao, Shengfu; Heitjan, Daniel F; Tan, Kay-See; Pontiggia, Laura; O'Dwyer, Peter J; Davis, Lisa E; Amaravadi, Ravi K

    2014-08-01

    Preclinical studies indicate autophagy inhibition with hydroxychloroquine (HCQ) can augment the efficacy of DNA-damaging therapy. The primary objective of this trial was to determine the maximum tolerated dose (MTD) and efficacy of HCQ in combination with radiation therapy (RT) and temozolomide (TMZ) for newly diagnosed glioblastoma (GB). A 3 + 3 phase I trial design followed by a noncomparative phase II study was conducted in GB patients after initial resection. Patients received HCQ (200 to 800 mg oral daily) with RT and concurrent and adjuvant TMZ. Quantitative electron microscopy and immunoblotting were used to assess changes in autophagic vacuoles (AVs) in peripheral blood mononuclear cells (PBMC). Population pharmacokinetic (PK) modeling enabled PK-pharmacodynamic correlations. Sixteen phase I subjects were evaluable for dose-limiting toxicities. At 800 mg HCQ/d, 3/3 subjects experienced Grade 3 and 4 neutropenia and thrombocytopenia, 1 with sepsis. HCQ 600 mg/d was found to be the MTD in this combination. The phase II cohort (n = 76) had a median survival of 15.6 mos with survival rates at 12, 18, and 24 mo of 70%, 36%, and 25%. PK analysis indicated dose-proportional exposure for HCQ. Significant therapy-associated increases in AV and LC3-II were observed in PBMC and correlated with higher HCQ exposure. These data establish that autophagy inhibition is achievable with HCQ, but dose-limiting toxicity prevented escalation to higher doses of HCQ. At HCQ 600 mg/d, autophagy inhibition was not consistently achieved in patients treated with this regimen, and no significant improvement in overall survival was observed. Therefore, a definitive test of the role of autophagy inhibition in the adjuvant setting for glioma patients awaits the development of lower-toxicity compounds that can achieve more consistent inhibition of autophagy than HCQ.

  12. The first preparative solution phase synthesis of melanotan II

    Directory of Open Access Journals (Sweden)

    2008-10-01

    Full Text Available Melanotan II is a synthetic cyclic heptapeptide used to prevent a sunlight-induced skin cancer by stimulating the skin tanning process. In this paper we report the first solution phase synthesis of the title compound. The hexapeptide sequence has been assembled by [(2+2+1+1] scheme. After removing the orthogonal protection, a carbodiimide mediated lactamization, involving the ε-amino group of lysine and γ-carboxy group of aspartic acid, led to a cyclic intermediate. Appending N-acetylnorleucine concluded the assembly of melanotan II molecule. Protection of the lateral groups in arginine and tryptophan was omitted for atom and step economy reasons. The total synthesis of melanotan II was accomplished in 12 steps with 2.6% overall yield, affording >90% pure peptide without using preparative chromatography.

  13. Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate) : a phase 2, randomised, controlled trial

    NARCIS (Netherlands)

    Khanna, Dinesh; Denton, Christopher P.; Jahreis, Angelika; van Laar, Jacob M.; Frech, Tracy M.; Anderson, Marina E.; Baron, Murray; Chung, Lorinda; Fierlbeck, Gerhard; Lakshminarayanan, Santhanam; Allanore, Yannick; Pope, Janet E.; Riemekasten, Gabriela; Steen, Virginia; Müller-Ladner, Ulf; Lafyatis, Robert; Stifano, Giuseppina; Spotswood, Helen; Chen-Harris, Haiyin; Dziadek, Sebastian; Morimoto, Alyssa; Sornasse, Thierry; Siegel, Jeffrey; Furst, Daniel E.

    2016-01-01

    Background Systemic sclerosis is a rare disabling autoimmune disease with few treatment options. The efficacy and safety of tocilizumab, an interleukin 6 receptor-α inhibitor, was assessed in the faSScinate phase 2 trial in patients with systemic sclerosis. Methods We did this double-blind,

  14. Data Quality Objective Summary Report for Phase II of the 105-F and DR Reactor Buildings

    International Nuclear Information System (INIS)

    Bauer, R.G.

    1998-01-01

    This data quality objective (DQO) process is to support planning and decision-making activities of Phase II decontamination and decommissioning (D and D) activities for the 105-F and 105-DR Reactor Buildings.The objective of this DQO is to determine the survey and characterization requirements for these rooms to provide the necessary information for worker safety, waste designation, recycle, reuse, and clean landfill disposal decisions during D and D

  15. How competitive are EU electricity markets? An assessment of ETS Phase II

    International Nuclear Information System (INIS)

    Castagneto-Gissey, Giorgio

    2014-01-01

    This paper studies the interactions between electricity and carbon allowance prices in the year-ahead energy markets of France, Germany, United Kingdom and the Nordic countries, during Phase II of the EU ETS. VAR and Granger-causality methods are used to analyze causal interfaces, whereas the volatility of electricity prices is studied with basic and asymmetric AR-GARCH models. Among the main results, the marginal rate at which carbon prices feed into electricity prices is shown to be ca. 135% in the EEX and Nord Pool markets, where electricity and carbon prices display bidirectional causality, and 109% in the UK. Therefore, generators in these markets internalized the cost of freely allotted emission allowances into their electricity prices considerably more than the proportionate increase in costs justified by effective carbon intensity. Moreover, electricity prices in France are found to Granger-cause the carbon price. This study also shows how European electricity prices are deeply linked to coal prices among other factors, both in terms of levels and volatility, regardless of the underlying fuel mix, and that coal was marginally more profitable than gas for electricity generation. EU policies aimed at increasing the carbon price are likely to be crucial in limiting the externalities involved in the transition to a low-carbon system. - Highlights: • The interactions between electricity and carbon prices during Phase II are investigated. • This work also studies the determinants of EU electricity price levels and volatilities. • Nord Pool, APX UK and EEX carbon cost pass-through rates emphasize low electricity market competitiveness. • Powernext electricity prices Granger-cause the Phase II carbon price. • Coal was marginally more profitable than gas during Phase II

  16. Phase II study of 4'-(9-acridinylamino) methanesulfon-m- anisidide (AMSA) in metastatic melanoma.

    Science.gov (United States)

    Legha, S S; Hall, S W; Powell, K C; Burgess, M A; Benjamin, R S; Gutterman, J U; Bodey, G P

    1980-01-01

    A phase II study of AMSA in previously treated patients with metastatic malignant melanoma was conducted. The dose schedule of AMSA was 40 mg/m2/day for 3 days repeated at 3-week intervals. Among the 30 evaluable patients, one achieved a complete response, one a partial response, and four had minor responses. Side effects included mild nausea and vomiting and moderate degree of myelosuppression. AMSA has poor activity against previously treated metastatic melanoma.

  17. Column Chromatography Of Co(II), Zn(II) And Eu(III) Using Pistachio Shell And Different Mobile Phases

    International Nuclear Information System (INIS)

    Abdel-Fattah, A.A.

    2009-01-01

    Pistachio shell particles (0.5-1 mm) have been applied as the stationary phase for studying the column chromatography of Co(II), Zn(II) and Eu(III) at room temperature; 26 + - 1 oC. This solid sorbent has been characterized by thermogravimetric analysis, infra-red spectroscopy and X-ray diffraction. Its surface area and percent of swelling have been also determined. Different eluting agents have been used for eluting the sorbed elements. The elution curves have been done from which the distribution coefficients (K d ), number of theoretical plates (N) and heights equivalent to theoretical plates (H) have been determined. Column performance studies have been conducted for a representative system under certain experimented conditions and Van Deemter equation has been applied. Thermodynamic studies have been applied and thermodynamic functions ( δG 0 ,δH 0 andδ S 0 ) have been calculated for this representative system by determining K d at three different room temperatures (18, 26 and 37 + - 1o C).

  18. Column Chromatography Of Co(II), Zn(II) And Eu(III) Using Pistachio Shell And Different Mobile Phases

    Energy Technology Data Exchange (ETDEWEB)

    Abdel-Fattah, A A [Nuclear Chemistry Department, Radioisotopes Production Division, Hot Laboratories Centre, Atomic Energy Authority, Cairo (Egypt)

    2009-07-01

    Pistachio shell particles (0.5-1 mm) have been applied as the stationary phase for studying the column chromatography of Co(II), Zn(II) and Eu(III) at room temperature; 26{sup +}-{sup 1}oC. This solid sorbent has been characterized by thermogravimetric analysis, infra-red spectroscopy and X-ray diffraction. Its surface area and percent of swelling have been also determined. Different eluting agents have been used for eluting the sorbed elements. The elution curves have been done from which the distribution coefficients (K{sub d}), number of theoretical plates (N) and heights equivalent to theoretical plates (H) have been determined. Column performance studies have been conducted for a representative system under certain experimented conditions and Van Deemter equation has been applied. Thermodynamic studies have been applied and thermodynamic functions ( {delta}G{sup 0} ,{delta}H{sup 0} and{delta} S{sup 0}) have been calculated for this representative system by determining K{sub d} at three different room temperatures (18, 26 and 37{sup +}-{sup 1o}C)

  19. Ginseng Berry Extract Prevents Atherogenesis via Anti-Inflammatory Action by Upregulating Phase II Gene Expression

    Directory of Open Access Journals (Sweden)

    Chun-Ki Kim

    2012-01-01

    Full Text Available Ginseng berry possesses higher ginsenoside content than its root, which has been traditionally used in herbal medicine for many human diseases, including atherosclerosis. We here examined the antiatherogenic effects of the Korean ginseng berry extract (KGBE and investigated its underlying mechanism of action in vitro and in vivo. Administration of KGBE decreased atherosclerotic lesions, which was inversely correlated with the expression levels of phase II genes to include heme oxygenase-1 (HO-1 and glutamine-cysteine ligase (GCL. Furthermore, KGBE administration suppressed NF-κB-mediated expression of atherogenic inflammatory genes (TNF-α, IL-1β, iNOS, COX-2, ICAM-1, and VCAM-1, without altering serum cholesterol levels, in ApoE-/- mice fed a high fat-diet. Treatment with KGBE increased phase II gene expression and suppressed lipopolysaccharide-induced reactive oxygen species production, NF-κB activation, and inflammatory gene expression in primary macrophages. Importantly, these cellular events were blocked by selective inhibitors of HO-1 and GCL. In addition, these inhibitors reversed the suppressive effect of KGBE on TNF-α-mediated induction of ICAM-1 and VCAM-1, resulting in decreased interaction between endothelial cells and monocytes. These results suggest that KGBE ameliorates atherosclerosis by inhibiting NF-κB-mediated expression of atherogenic genes via upregulation of phase II enzymes and thus has therapeutic or preventive potential for atherosclerosis.

  20. Evaluation of Beam Loss and Energy Depositions for a Possible Phase II Design for LHC Collimation

    International Nuclear Information System (INIS)

    Lari, L.; Assmann, R.; Bracco, C.; Brugger, M.; Cerutti, F.; Doyle, E.; Ferrari, A.; Keller, L.; Lundgren, S.; Markiewicz, Thomas W.; Mauri, M.; Redaelli, S.; Sarchiapone, L.; Smith, J.; Vlachoudis, V.; Weiler, T.

    2011-01-01

    The LHC beams are designed to have high stability and to be stored for many hours. The nominal beam intensity lifetime is expected to be of the order of 20h. The Phase II collimation system has to be able to handle particle losses in stable physics conditions at 7 TeV in order to avoid beam aborts and to allow correction of parameters and restoration to nominal conditions. Monte Carlo simulations are needed in order to evaluate the behavior of metallic high-Z collimators during operation scenarios using a realistic distribution of losses, which is a mix of the three limiting halo cases. Moreover, the consequences in the IR7 insertion of the worst (case) abnormal beam loss are evaluated. The case refers to a spontaneous trigger of the horizontal extraction kicker at top energy, when Phase II collimators are used. These studies are an important input for engineering design of the collimation Phase II system and for the evaluation of their effect on adjacent components. The goal is to build collimators that can survive the expected conditions during LHC stable physics runs, in order to avoid quenches of the SC magnets and to protect other LHC equipments.

  1. Evaluation of Beam Losses And Energy Deposition for a Possible Phase II Design for LHC Collimation

    International Nuclear Information System (INIS)

    Lari, L.; Bracco, C.; Assmann, R.W.; Brugger, M.; Cerutti, F.; Ferrari, A.; Mauri, M.; Redaelli, S.; Sarchiapone, L.; Vlachoudis, V.; Weiler, T.; Doyle, J.E.; Keller, L.; Lundgren, S.A.; Markiewicz, T.W.; Smith, J.C.

    2011-01-01

    The Large Hadron Collider (LHC) beams are designed to have high stability and to be stored for many hours. The nominal beam intensity lifetime is expected to be of the order of 20h. The Phase II collimation system has to be able to handle particle losses in stable physics conditions at 7 TeV in order to avoid beam aborts and to allow correction of parameters and restoration to nominal conditions. Monte Carlo simulations are needed in order to evaluate the behavior of metallic high-Z collimators during operation scenarios using a realistic distribution of losses, which is a mix of the three limiting halo cases. Moreover, the consequences in the IR7 insertion of the worst (case) abnormal beam loss are evaluated. The case refers to a spontaneous trigger of the horizontal extraction kicker at top energy, when Phase II collimators are used. These studies are an important input for engineering design of the collimation Phase II system and for the evaluation of their effect on adjacent components. The goal is to build collimators that can survive the expected conditions during LHC stable physics runs, in order to avoid quenches of the SC magnets and to protect other LHC equipments.

  2. Relationship between trust in God and self – efficacy With mental health in type II diabetics

    Directory of Open Access Journals (Sweden)

    Susan Behdani

    2012-12-01

    Conclusion: Regarding the increase in the prevalence of diabetes mellitus, the disease is one of the notorious health problems in the world. Thus, intervention aimed at increasing religious faith and self-efficacy in order to do self-care activities will be useful in decreasing diabetic complications.

  3. Clinical effects of Angelica dahurica dressing on patients with I-II phase pressure sores.

    Science.gov (United States)

    Gong, Fen; Niu, Junzhi; Pei, Xing

    2016-11-02

    Angelica dahurica is a well-known traditional Chinese Medicine (TCM), while little information is available about its effects on pressure sores. We aimed to investigate the clinical effect of Angelica dahurica on patients with I-II phase pressure sores, as well as the underlying mechanism. Patients (n = 98) with phase I and phase II pressure sores were enrolled and randomly assigned to control and treated groups. In addition to holistic nursing, patients in the control group received compound clotrimazole cream, while patients in the treated group received continuous 4 weeks of external application of Angelica dahurica dressing. Therapeutic effect was recorded, along with the levels of interleukin-8 (IL-8), epidermal growth factor (EGF), transforming growth factor (TGF)-β, and vascular endothelial growth factor (VEGF). Besides, HaCaT cells were cultured with different concentrations of Angelica dahurica, and then cell viability, clone formation numbers, cell cycle, and levels of cyclin D1 and cyclin-dependent kinase (CDK) 2 were determined. The total effective rate in the treated group was significantly higher than in the control group. Levels of IL-8, EGF, TGF-β, and VEGF were statistically increased by Angelica dahurica. In addition, the cell viability and clone formation numbers were significantly upregulated by Angelica dahurica in a dose-dependent manner. Also, the percentage of cells in G0/G1 phase, and levels of cyclin D1 and CDK2 were significantly elevated. Our results suggest that Angelica dahurica may provide an effective clinical treatment for I-II phase pressure sores.

  4. National Geoscience Data Repository System, Phase II. Final report, January 30, 1995--January 28, 1997

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1998-04-01

    The American Geological Institute (AGI) has completed Phase II of a project to establish a National Geoscience Data Repository System (NGDRS). The project`s primary objectives are to preserve geoscience data in jeopardy of being destroyed and to make that data available to those who have a need to use it in future investigations. These data are available for donation to the public as a result of the downsizing that has occurred in the major petroleum and mining companies in the United States for the past decade. In recent years, these companies have consolidated domestic operations, sold many of their domestic properties and relinquished many of their leases. The scientific data associated with those properties are no longer considered to be useful assets and are consequently in danger of being lost forever. The national repository project will make many of these data available to the geoscience community for the first time. To address this opportunity, AGI sought support from the Department of Energy (DOE) in 1994 to initiate the NGDRS Phase I feasibility study to determine the types and quantity of data that companies would be willing to donate. The petroleum and mining companies surveyed indicated that they were willing to donate approximately five million well logs, one hundred million miles of seismic reflection data, millions of linear feet of core and cuttings, and a variety of other types of scientific data. Based on the positive results of the Phase I study, AGI undertook Phase II of the program in 1995. Funded jointly by DOE and industry, Phase II encompasses the establishment of standards for indexing and cataloging of geoscience data and determination of the costs of transferring data from the private sector to public-sector data repositories. Pilot projects evaluated the feasibility of the project for transfer of different data types and creation of a Web-based metadata supercatalog and browser.

  5. A phase II randomized trial of Observation versus stereotactic ablative RadiatIon for OLigometastatic prostate CancEr (ORIOLE).

    Science.gov (United States)

    Radwan, Noura; Phillips, Ryan; Ross, Ashley; Rowe, Steven P; Gorin, Michael A; Antonarakis, Emmanuel S; Deville, Curtiland; Greco, Stephen; Denmeade, Samuel; Paller, Channing; Song, Daniel Y; Diehn, Maximilian; Wang, Hao; Carducci, Michael; Pienta, Kenneth J; Pomper, Martin G; DeWeese, Theodore L; Dicker, Adam; Eisenberger, Mario; Tran, Phuoc T

    2017-06-29

    We describe a randomized, non-blinded Phase II interventional study to assess the safety and efficacy of stereotactic ablative radiotherapy (SABR) for hormone-sensitive oligometastatic prostate adenocarcinoma, and to describe the biology of the oligometastatic state using immunologic, cellular, molecular, and functional imaging correlates. 54 men with oligometastatic prostate adenocarcinoma will be accrued. The primary clinical endpoint will be progression at 6 months from randomization with the hypothesis that SABR to all metastases will forestall progression by disrupting the metastatic process. Secondary clinical endpoints will include local control at 6 months post-SABR, toxicity and quality of life, and androgen deprivation therapy (ADT)-free survival (ADT-FS). Further fundamental analysis of the oligometastatic state with be achieved through correlation with investigational 18 F-DCFPyL PET/CT imaging and measurement of circulating tumor cells, circulating tumor DNA, and circulating T-cell receptor repertoires, facilitating an unprecedented opportunity to characterize, in isolation, the effects of SABR on the dynamics of and immunologic response to oligometastatic disease. Patients will be randomized 2:1 to SABR or observation with minimization to balance assignment by primary intervention, prior hormonal therapy, and PSA doubling time. Progression after 6 months will be compared using Fisher's exact test. Hazard ratios and Kaplan-Meier estimates of progression free survival (PFS), ADT free survival (ADT-FS), time to locoregional progression (TTLP) and time to distant progression (TTDP) will be calculated based on an intention-to-treat. Local control will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Withdrawal from the study prior to 6 months will be counted as progression. Adverse events will be summarized by type and grade. Quality of life pre- and post- SABR will be measured by Brief Pain Inventory. The ORIOLE

  6. A Phase II Study of Weekly Docetaxel as Second-Line Chemotherapy in Patients With Metastatic Urothelial Carcinoma.

    Science.gov (United States)

    Kim, Young Saing; Lee, Soon Il; Park, Se Hoon; Park, Silvia; Hwang, In Gyu; Lee, Sang-Cheol; Sun, Jong-Mu; Lee, Jeeyun; Lim, Ho Yeong

    2016-02-01

    The present multicenter phase II study evaluated the efficacy and safety of weekly docetaxel as second-line chemotherapy for metastatic urothelial carcinoma. Weekly docetaxel was well tolerated but demonstrated modest activity, with a response rate of 6%, a median progression-free survival (PFS) of 1.4 months, and a median overall survival (OS) of 8.3 months. The dichotomy between PFS and OS was likely associated with subsequent platinum-based chemotherapy received by 58% of the patients. Docetaxel is commonly used for second-line therapy for metastatic urothelial carcinoma (UC). However, myelosuppression is a substantial concern when the traditional 3-week docetaxel cycle is used. The present multicenter phase II study evaluated the efficacy and safety of weekly docetaxel as second-line chemotherapy for metastatic UC. Patients with progression after previous platinum-based chemotherapy for advanced or metastatic disease were treated with docetaxel 30 mg/m(2) on days 1 and 8 every 21 days. The primary endpoint was the response rate. The study enrolled 31 patients. Their median age was 64 years (range, 40-79 years). An Eastern Cooperative Oncology Group performance status of 1, liver metastasis, and a hemoglobin level chemotherapy had been administered for metastatic disease in 29 patients (94%). Although fatigue (13%) and anorexia (6%) were the most frequently observed grade 3 to 4 toxicities, the safety profiles were generally mild and manageable. Two patients (6%) achieved an objective response, which was maintained for 3.0 to 7.8 months. Eight patients experienced disease stabilization (disease control rate, 32%). The median progression-free survival (PFS) and overall survival (OS) were 1.4 months (95% confidence interval [CI], 1.3-1.6) and 8.3 months (95% CI, 5.9-10.6), respectively. A relatively long OS was associated with further salvage platinum-based chemotherapy (n = 18, 58%) showing an encouraging activity (response rate, 44%; median PFS, 4.0 months

  7. In vivo induction of phase II detoxifying enzymes, glutathione transferase and quinone reductase by citrus triterpenoids

    Directory of Open Access Journals (Sweden)

    Ahmad Hassan

    2010-09-01

    Full Text Available Abstract Background Several cell culture and animal studies demonstrated that citrus bioactive compounds have protective effects against certain types of cancer. Among several classes of citrus bioactive compounds, limonoids were reported to prevent different types of cancer. Furthermore, the structures of citrus limonoids were reported to influence the activity of phase II detoxifying enzymes. The purpose of the study was to evaluate how variations in the structures of citrus limonoids (namely nomilin, deacetyl nomilin, and isoobacunoic acid and a mixture of limonoids would influence phase II enzyme activity in excised tissues from a mouse model. Methods In the current study, defatted sour orange seed powder was extracted with ethyl acetate and subjected to silica gel chromatography. The HPLC, NMR and mass spectra were used to elucidate the purity and structure of compounds. Female A/J mice were treated with three limonoids and a mixture in order to evaluate their effect on phase II enzymes in four different tissues. Assays for glutathione S-transferase and NAD(PH: quinone reductase (QR were used to evaluate induction of phase II enzymatic activity. Results The highest induction of GST against 1-chloro-2,4-dinitrobenzene (CDNB was observed in stomach (whole, 58% by nomilin, followed by 25% isoobacunoic acid and 19% deacetyl nomilin. Deacetyl nomilin in intestine (small as well as liver significantly reduced GST activity against CDNB. Additionally isoobacunoic acid and the limonoid mixture in liver demonstrated a significant reduction of GST activity against CDNB. Nomilin significantly induced GST activity against 4-nitroquinoline 1-oxide (4NQO, intestine (280% and stomach (75% while deacetyl nomilin showed significant induction only in intestine (73%. Induction of GST activity was also observed in intestine (93% and stomach (45% treated with the limonoid mixture. Finally, a significant induction of NAD(PH: quinone reductase (QR activity was

  8. Highly selective solid-phase extraction of trace Pd(II) by murexide functionalized halloysite nanotubes

    Energy Technology Data Exchange (ETDEWEB)

    Li Ruijun; He Qun; Hu Zheng; Zhang Shengrui [Department of Chemistry, Lanzhou University, Lanzhou 730000 (China); Key Laboratory of Nonferrous Metal Chemistry and Resources Utilization of Gansu Province, Lanzhou 730000 (China); Zhang Lijun [Faculty of Science and Engineer, Curtin University, Perth, WA 6845 (Australia); Chang Xijun, E-mail: lirj2010@lzu.edu.cn [Department of Chemistry, Lanzhou University, Lanzhou 730000 (China); Key Laboratory of Nonferrous Metal Chemistry and Resources Utilization of Gansu Province, Lanzhou 730000 (China)

    2012-02-03

    Graphical abstract: Murexide functionalized halloysite nanotubes have been developed to separate and concentrate trace Pd(II) from aqueous samples. Parameters that affected the sorption and elution efficiency were studied in column mode, and the new adsorbent presented high selectivity and adsorption capacity for the solid phase extraction of trace Pd(II). Highlights: Black-Right-Pointing-Pointer Murexide modified halloysite nanotubes as adsorbent has been reported originally. Black-Right-Pointing-Pointer This adsorbent has a unique selectivity for Pd(II) at pH 1.0. Black-Right-Pointing-Pointer This adsorbent had high adsorption capacity for Pd(II). Black-Right-Pointing-Pointer The precision and accuracy of the method are satisfactory. - Abstract: The originality on the high efficiency of murexide modified halloysite nanotubes as a new adsorbent of solid phase extraction has been reported to preconcentrate and separate Pd(II) in solution samples. The new adsorbent was confirmed by Fourier transformed infrared spectra, X-ray diffraction, scanning electron microscope, transmission electron microscope and N{sub 2} adsorption-desorption isotherms. Effective preconcentration conditions of analyte were examined using column procedures prior to detection by inductively coupled plasma-optical emission spectrometry (ICP-OES). The effects of pH, the amount of adsorbent, the sample flow rate and volume, the elution condition and the interfering ions were optimized in detail. Under the optimized conditions, Pd(II) could be retained on the column at pH 1.0 and quantitatively eluted by 2.5 mL of 0.01 mol L{sup -1} HCl-3% thiourea solution at a flow rate of 2.0 mL min{sup -1}. The analysis time was 5 min. An enrichment factor of 120 was accomplished. Common interfering ions did not interfere in both separation and determination. The maximum adsorption capacity of the adsorbent at optimum conditions was found to be 42.86 mg g{sup -1} for Pd(II). The detection limit (3{sigma}) of

  9. Highly selective solid-phase extraction of trace Pd(II) by murexide functionalized halloysite nanotubes

    International Nuclear Information System (INIS)

    Li Ruijun; He Qun; Hu Zheng; Zhang Shengrui; Zhang Lijun; Chang Xijun

    2012-01-01

    Graphical abstract: Murexide functionalized halloysite nanotubes have been developed to separate and concentrate trace Pd(II) from aqueous samples. Parameters that affected the sorption and elution efficiency were studied in column mode, and the new adsorbent presented high selectivity and adsorption capacity for the solid phase extraction of trace Pd(II). Highlights: ► Murexide modified halloysite nanotubes as adsorbent has been reported originally. ► This adsorbent has a unique selectivity for Pd(II) at pH 1.0. ► This adsorbent had high adsorption capacity for Pd(II). ► The precision and accuracy of the method are satisfactory. - Abstract: The originality on the high efficiency of murexide modified halloysite nanotubes as a new adsorbent of solid phase extraction has been reported to preconcentrate and separate Pd(II) in solution samples. The new adsorbent was confirmed by Fourier transformed infrared spectra, X-ray diffraction, scanning electron microscope, transmission electron microscope and N 2 adsorption–desorption isotherms. Effective preconcentration conditions of analyte were examined using column procedures prior to detection by inductively coupled plasma-optical emission spectrometry (ICP-OES). The effects of pH, the amount of adsorbent, the sample flow rate and volume, the elution condition and the interfering ions were optimized in detail. Under the optimized conditions, Pd(II) could be retained on the column at pH 1.0 and quantitatively eluted by 2.5 mL of 0.01 mol L −1 HCl–3% thiourea solution at a flow rate of 2.0 mL min −1 . The analysis time was 5 min. An enrichment factor of 120 was accomplished. Common interfering ions did not interfere in both separation and determination. The maximum adsorption capacity of the adsorbent at optimum conditions was found to be 42.86 mg g −1 for Pd(II). The detection limit (3σ) of the method was 0.29 ng mL −1 , and the relative standard deviation (RSD) was 3.1% (n = 11). The method was

  10. Phase II and III the next generation of CLS beamline control and data acquisition systems

    International Nuclear Information System (INIS)

    Matias, E.; Beauregard, D.; Berg, R.; Black, G.; Boots, M.J.; Dolton, W.; Hunter, D.; Igarashi, R.; Liu, D.; Maxwell, D.; Miller, C.D.; Wilson, T.; Wright, G.

    2012-01-01

    The Canadian Light Source (CLS) is nearing the completion of its suite of Phase II Beamlines and in detailed design of its Phase III Beamlines. The paper presents an overview of the overall approach adopted by CLS in the development of beamline control and data acquisition systems. Building on the experience of our first phase of beamlines the CLS has continued to make extensive use of EPICS with EDM and QT based user interfaces. Increasing interpretive languages such as Python are finding a place in the beamline control systems. Web based environment such as ScienceStudio have also found a prominent place in the control system architecture as we move to tighter integration between data acquisition, visualization and data analysis. (authors)

  11. NASA's GeneLab Phase II: Federated Search and Data Discovery

    Science.gov (United States)

    Berrios, Daniel C.; Costes, Sylvain V.; Tran, Peter B.

    2017-01-01

    GeneLab is currently being developed by NASA to accelerate 'open science' biomedical research in support of the human exploration of space and the improvement of life on earth. Phase I of the four-phase GeneLab Data Systems (GLDS) project emphasized capabilities for submission, curation, search, and retrieval of genomics, transcriptomics and proteomics ('omics') data from biomedical research of space environments. The focus of development of the GLDS for Phase II has been federated data search for and retrieval of these kinds of data across other open-access systems, so that users are able to conduct biological meta-investigations using data from a variety of sources. Such meta-investigations are key to corroborating findings from many kinds of assays and translating them into systems biology knowledge and, eventually, therapeutics.

  12. NASAs GeneLab Phase II: Federated Search and Data Discovery

    Science.gov (United States)

    Berrios, Daniel C.; Costes, Sylvain; Tran, Peter

    2017-01-01

    GeneLab is currently being developed by NASA to accelerate open science biomedical research in support of the human exploration of space and the improvement of life on earth. Phase I of the four-phase GeneLab Data Systems (GLDS) project emphasized capabilities for submission, curation, search, and retrieval of genomics, transcriptomics and proteomics (omics) data from biomedical research of space environments. The focus of development of the GLDS for Phase II has been federated data search for and retrieval of these kinds of data across other open-access systems, so that users are able to conduct biological meta-investigations using data from a variety of sources. Such meta-investigations are key to corroborating findings from many kinds of assays and translating them into systems biology knowledge and, eventually, therapeutics.

  13. Chromospheric oscillations observed with OSO 8. III. Average phase spectra for Si II

    International Nuclear Information System (INIS)

    White, O.R.; Athay, R.G.

    1979-01-01

    Time series of intensity and Doppler-shift fluctuations in the Si II emission lines lambda816.93 and lambda817.45 are Fourier analyzed to determine the frequency variation of phase differences between intensity and velocity and between these two lines formed 300 km apart in the middle chromosphere. Average phase spectra show that oscillations between 2 and 9 mHz in the two lines have time delays from 35 to 40 s, which is consistent with the upward propagation of sound wave at 8.6-7.5 km s -1 . In this same frequency band near 3 mHz, maximum brightness leads maximum blueshift by 60 0 . At frequencies above 11 mHz where the power spectrum is flat, the phase differences are uncertain, but approximately 65% of the cases indicate upward propagation. At these higher frequencies, the phase lead between intensity and blue Doppler shift ranges from 0 0 to 180 0 with an average value of 90 0 . However, the phase estimates in this upper band are corrupted by both aliasing and randomness inherent to the measured signals. Phase differences in the two narrow spectral features seen at 10.5 and 27 mHz in the power spectra are shown to be consistent with properties expected for aliases of the wheel rotation rate of the spacecraft wheel section

  14. Ternary copper(II) complex: NCI60 screening, toxicity studies, and evaluation of efficacy in xenograft models of nasopharyngeal carcinoma

    Science.gov (United States)

    Chu, Tai-Lin; Abdul Aziz, Norazlin; Mohd Kornain, Noor-Kaslina; Samiulla, D. S.; Lo, Kwok-Wai; Ng, Chew-Hee

    2018-01-01

    Copper(II) ternary complex, [Cu(phen)(C-dmg)(H2O)]NO3 was evaluated against a panel of cell lines, tested for in vivo efficacy in nasopharyngeal carcinoma xenograft models as well as for toxicity in NOD scid gamma mice. The Cu(II) complex displayed broad spectrum cytotoxicity against multiple cancer types, including lung, colon, central nervous system, melanoma, ovarian, and prostate cancer cell lines in the NCI-60 panel. The Cu(II) complex did not cause significant induction of cytochrome P450 (CYP) 3A and 1A enzymes but moderately inhibited CYP isoforms 1A2, 2C9, 2C19, 2D6, 2B6, 2C8 and 3A4. The complex significantly inhibited tumor growth in nasopharyngeal carcinoma xenograft bearing mice models at doses which were well tolerated without causing significant or permanent toxic side effects. However, higher doses which resulted in better inhibition of tumor growth also resulted in toxicity. PMID:29329342

  15. Screened selection design for randomised phase II oncology trials: an example in chronic lymphocytic leukaemia.

    Science.gov (United States)

    Yap, Christina; Pettitt, Andrew; Billingham, Lucinda

    2013-07-03

    As there are limited patients for chronic lymphocytic leukaemia trials, it is important that statistical methodologies in Phase II efficiently select regimens for subsequent evaluation in larger-scale Phase III trials. We propose the screened selection design (SSD), which is a practical multi-stage, randomised Phase II design for two experimental arms. Activity is first evaluated by applying Simon's two-stage design (1989) on each arm. If both are active, the play-the-winner selection strategy proposed by Simon, Wittes and Ellenberg (SWE) (1985) is applied to select the superior arm. A variant of the design, Modified SSD, also allows the arm with the higher response rates to be recommended only if its activity rate is greater by a clinically-relevant value. The operating characteristics are explored via a simulation study and compared to a Bayesian Selection approach. Simulations showed that with the proposed SSD, it is possible to retain the sample size as required in SWE and obtain similar probabilities of selecting the correct superior arm of at least 90%; with the additional attractive benefit of reducing the probability of selecting ineffective arms. This approach is comparable to a Bayesian Selection Strategy. The Modified SSD performs substantially better than the other designs in selecting neither arm if the underlying rates for both arms are desirable but equivalent, allowing for other factors to be considered in the decision making process. Though its probability of correctly selecting a superior arm might be reduced, it still performs reasonably well. It also reduces the probability of selecting an inferior arm. SSD provides an easy to implement randomised Phase II design that selects the most promising treatment that has shown sufficient evidence of activity, with available R codes to evaluate its operating characteristics.

  16. A Phase I-II dose escalation study of fixed-dose rate gemcitabine, oxaliplatin and capecitabine every two weeks in advanced cholangiocarcinomas

    DEFF Research Database (Denmark)

    Lassen, Ulrik V; Jensen, Lars Henrik; Sorensen, Morten

    2011-01-01

    (O) and capecitabine (C), and evaluate the safety and efficacy of this regimen in patients with advanced cholangiocarcinoma (CC). Methods. In the Phase I part of the study a dose-escalation schedule of FDR G, O and C, administered every two weeks, was performed in patients with solid tumours...... and no other treatments or advanced CC. In the Phase II part response rate, toxicity, progression-free survival (PFS) and overall survival was evaluated in patients with newly diagnosed advanced CC. Results. Thirty-six patients entered the Phase I part and G 1 000 mg/m(2) day 1 and 15, O 60 mg/m(2) day 1...... and 15, and C 1 000 mg/m(2) BID day 1-7 and day 15-21 were established as MTD. In the Phase II part, 41 patients with advanced CC were included. Overall response rate was 34% and 51% had stable disease, resulting in a clinical benefit rate of 85%. Grade III and IV adverse events were rare. Median...

  17. Phase I/II study of gefitinib (Iressa(®)) and vorinostat (IVORI) in previously treated patients with advanced non-small cell lung cancer.

    Science.gov (United States)

    Han, Ji-Youn; Lee, Soo Hyun; Lee, Geon Kook; Yun, Tak; Lee, Young Joo; Hwang, Kum Hui; Kim, Jin Young; Kim, Heung Tae

    2015-03-01

    Vorinostat has been shown to overcome resistance to gefitinib. We performed a phase I/II study combining gefitinib with vorinostat in previously treated non-small cell lung cancer (NSCLC). A 3 + 3 dose-escalation design was used to determine maximum tolerated dose (MTD) and recommended phase II dose (RP2D). Three dose levels were tested: 250 mg/day gefitinib on days 1-28 and 200, 300 or 400 mg/day vorinostat on days 1-7, and 15-21 out of every 28 days. The primary endpoint was median progression-free survival (PFS). Fifty-two patients were enrolled and treated (43 in phase II). The median age was 59 years, 28 patients were male, 44 had adenocarcinoma, 29 had never smoked, and 36 had undergone one prior treatment. Twenty-two patients exhibited sensitive EGFR mutations. Planned dose escalation was completed without reaching the MTD. The RP2D was 250 mg gefitinib and 400 mg vorinostat. In 43 assessable patients in phase II, the median PFS was 3.2 months; the overall survival (OS) was 19.0 months. There were 16 partial responses and six cases of stable disease. In EGFR-mutant NSCLC, response rate was 77 %, median PFS was 9.1 months, and median OS was 24.1 months. The most common adverse events were anorexia and diarrhea. Treatment with 250 mg gefitinib daily with biweekly 400 mg/day vorinostat was feasible and well tolerated. In an unselected patient population, this combination dose did not improve PFS. However, this combination showed a potential for improving efficacy of gefitinib in EGFR-mutant NSCLC (NCT01027676).

  18. Phase II Study of Short-Course Radiotherapy Plus Concomitant and Adjuvant Temozolomide in Elderly Patients With Glioblastoma

    Energy Technology Data Exchange (ETDEWEB)

    Minniti, Giuseppe, E-mail: Giuseppe.Minniti@ospedalesantandrea.it [Department of Radiation Oncology, Sant' Andrea Hospital, University ' La Sapienza,' Rome (Italy); Department of Neurological Sciences, Neuromed Institute, Pozzilli (Italy); Lanzetta, Gaetano [Department of Neurological Sciences, Neuromed Institute, Pozzilli (Italy); Scaringi, Claudia [Department of Radiation Oncology, Sant' Andrea Hospital, University ' La Sapienza,' Rome (Italy); Caporello, Paola [Department of Medical Oncology, Sant' Andrea Hospital, University ' La Sapienza,' Rome (Italy); Salvati, Maurizio [Department of Neurosurgery, Umberto I Hospital, University ' La Sapienza,' Rome (Italy); Arcella, Antonella [Department of Neurological Sciences, Neuromed Institute, Pozzilli (Italy); De Sanctis, Vitaliana [Department of Radiation Oncology, Sant' Andrea Hospital, University ' La Sapienza,' Rome (Italy); Giangaspero, Felice [Department of Neurological Sciences, Neuromed Institute, Pozzilli (Italy); Department of Pathology, Umberto I Hospital, University ' La Sapienza,' Rome (Italy); Enrici, Riccardo Maurizi [Department of Radiation Oncology, Sant' Andrea Hospital, University ' La Sapienza,' Rome (Italy)

    2012-05-01

    Purpose: Radiotherapy (RT) and chemotherapy may prolong survival in older patients (age {>=}70 years) with glioblastoma multiforme (GBM), although the survival benefits remain poor. This Phase II multicenter study was designed to evaluate the efficacy and safety of an abbreviated course of RT plus concomitant and adjuvant temozolomide (TMZ) in older patients with GBM. Patients and Methods: Seventy-one eligible patients 70 years of age or older with newly diagnosed GBM and a Karnofsky performance status {>=}60 were treated with a short course of RT (40 Gy in 15 fractions over 3 weeks) plus TMZ at the dosage of 75 mg/m{sup 2} per day followed by 12 cycles of adjuvant TMZ (150-200 mg/m{sup 2} for 5 days during each 28-day cycle). The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival and toxicity. Results: The Median OS was 12.4 months, and the 1-year and 2-year OS rates were 58% and 20%, respectively. The median and 1-year rates of progression-free survival were 6 months and 20%, respectively. All patients completed the planned programme of RT. Grade 3 or 4 adverse events occurred in 16 patients (22%). Grade 3 and 4 neutropenia and/or thrombocytopenia occurred in 10 patients (15%), leading to the interruption of treatment in 6 patients (8%). Nonhematologic Grade 3 toxicity was rare, and included fatigue in 4 patients and cognitive disability in 1 patient. Conclusions: A combination of an abbreviated course of RT plus concomitant and adjuvant TMZ is well tolerated and may prolong survival in elderly patients with GBM. Future randomized studies need to evaluate the efficacy and toxicity of different schedules of RT in association with chemotherapy.

  19. Phase II/III Study of Radiofrequency Ablation Combined with Cytokine-Induced Killer Cells Treating Colorectal Liver Metastases

    Directory of Open Access Journals (Sweden)

    Xiaodong Li

    2016-11-01

    Full Text Available Purpose: This phase II/III, non-randomized clinical trial aimed to determine the efficacy and safety of the combination of radiofrequency ablation (RFA and cytokine-induced killer (CIK cells transfusion for patients with colorectal liver metastases (CRLMs. Experimental Design: A total of 60 eligible patients with CRLMs were enrolled and divided into Group A (RFA alone, n = 30 and Group B (RFA plus CIK, n = 30, and following enzyme-linked immunosorbent spot assay was performed in 8 patients with CEA > 50 ng/mL pre-RFA and 7 days post-RFA and CIK treatment, respectively. Results: The median progression-free survival (PFS times of Group A and Group B were 18.5 months and 23 months, respectively (P = 0.0336. The 3-year progression-free rates were 13.3% in Group A and 20.3% in Group B, respectively. The median overall survival time was 43 months in Group A, and not reached in Group B. The 3-year survival rates were 64.6% in Group A and 81.0% in Group B, respectively (P = 0.1187. Among the 8 patients with CEA > 50ng/mL, 6 had increase of circulating CEA-specific T cells after RFA (P = 0.010. After CIK cell therapy, the number of CEA-specific T cells increased in all the 8 patients comparing with that pre-treatment (P = 0.001 and in 7 patients comparing with that post-RFA (P = 0.028. Conclusions: We firstly confirm that the combination of RFA and CIK cells boosts CEA-specific T cell response and shows to be an efficacious and safe treatment modality for patients with CRLMs.

  20. Selective solid-phase extraction of Ni(II) by an ion-imprinted polymer from water samples

    International Nuclear Information System (INIS)

    Saraji, Mohammad; Yousefi, Hamideh

    2009-01-01

    A new ion-imprinted polymer (IIP) material was synthesized by copolymerization of 4-vinylpyridine as monomer, ethyleneglycoldimethacrylate as crosslinking agent and 2,2'-azobis-sobutyronitrile as initiator in the presence of Ni-dithizone complex. The IIP was used as sorbent in a solid-phase extraction column. The effects of sampling volume, elution conditions, sample pH and sample flow rate on the extraction of Ni ions form water samples were studied. The maximum adsorption capacity and the relative selectivity coefficients of imprinted polymer for Ni(II)/Co(II), Ni(II)/Cu(II) and Ni(II)/Cd(II) were calculated. Compared with non-imprinted polymer particles, the IIP had higher selectivity for Ni(II). The relative selectivity factor (α r ) values of Ni(II)/Co(II), Ni(II)/Cu(II) and Ni(II)/Cd(II) were 21.6, 54.3, and 22.7, respectively, which are greater than 1. The relative standard deviation of the five replicate determinations of Ni(II) was 3.4%. The detection limit for 150 mL of sample was 1.6 μg L -1 using flame atomic absorption spectrometry. The developed method was successfully applied to the determination of trace nickel in water samples with satisfactory results.

  1. Development of methods for measuring materials nuclear characteristics, Phases, I, II, II and IV; Razvijanje metoda merenja nuklearnih karakteristika materijala, I, II, II i VI faza

    Energy Technology Data Exchange (ETDEWEB)

    Maglic, R [Boris Kidric Institute of Nuclear Sciences Vinca, Belgrade (Yugoslavia)

    1963-04-15

    This report contains the following phases of the project 'measurement of nuclear characteristics of reactor materials': nuclear performances of the neutron chopper; method for measuring total effective cross sections by transmission method on the chopper; review of methods for measuring activation cross sections; measurement of neutron spectra of the RA reactor and measurement of total effective cross section of gold by using the chopper.

  2. Exatecan in pretreated adult patients with advanced soft tissue sarcoma: results of a phase II--study of the EORTC Soft Tissue and Bone Sarcoma Group

    DEFF Research Database (Denmark)

    Reichardt, P; Nielsen, Ole Steen; Bauer, S

    2007-01-01

    No standard treatment is established for patients with advanced soft tissue sarcoma after previous chemotherapy with anthracyclines and ifosfamide, given either in combination or sequentially. Exatecan (DX-8951f) is a totally synthetic analogue of the topoisomerase I-inhibitor camptothecin, which...... was synthesised to impart increased aqueous solubility, greater tumour efficacy, and less toxicity than camptothecin itself, topotecan or irinotecan. Since some activity against soft tissue sarcomas, especially leiomyosarcomas, has been reported for topoisomerase I-inhibitors, a study with a new and more potent...... agent seemed justified. We report on a prospective multicentre phase II study of Exatecan in adult soft tissue sarcomas failing 1 or 2 lines of chemotherapy in advanced phase, performed within the STBSG of EORTC. Thirty-nine patients (16 leiomyosarcomas and 23 other histologies) were included in two...

  3. Casein Kinase 1 Coordinates Cohesin Cleavage, Gametogenesis, and Exit from M Phase in Meiosis II.

    Science.gov (United States)

    Argüello-Miranda, Orlando; Zagoriy, Ievgeniia; Mengoli, Valentina; Rojas, Julie; Jonak, Katarzyna; Oz, Tugce; Graf, Peter; Zachariae, Wolfgang

    2017-01-09

    Meiosis consists of DNA replication followed by two consecutive nuclear divisions and gametogenesis or spore formation. While meiosis I has been studied extensively, less is known about the regulation of meiosis II. Here we show that Hrr25, the conserved casein kinase 1δ of budding yeast, links three mutually independent key processes of meiosis II. First, Hrr25 induces nuclear division by priming centromeric cohesin for cleavage by separase. Hrr25 simultaneously phosphorylates Rec8, the cleavable subunit of cohesin, and removes from centromeres the cohesin protector composed of shugoshin and the phosphatase PP2A. Second, Hrr25 initiates the sporulation program by inducing the synthesis of membranes that engulf the emerging nuclei at anaphase II. Third, Hrr25 mediates exit from meiosis II by activating pathways that trigger the destruction of M-phase-promoting kinases. Thus, Hrr25 synchronizes formation of the single-copy genome with gamete differentiation and termination of meiosis. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. 37 GHz METHANOL MASERS : HORSEMEN OF THE APOCALYPSE FOR THE CLASS II METHANOL MASER PHASE?

    International Nuclear Information System (INIS)

    Ellingsen, S. P.; Breen, S. L.; Sobolev, A. M.; Voronkov, M. A.; Caswell, J. L.; Lo, N.

    2011-01-01

    We report the results of a search for class II methanol masers at 37.7, 38.3, and 38.5 GHz toward a sample of 70 high-mass star formation regions. We primarily searched toward regions known to show emission either from the 107 GHz class II methanol maser transition, or from the 6.035 GHz excited OH transition. We detected maser emission from 13 sources in the 37.7 GHz transition, eight of these being new detections. We detected maser emission from three sources in the 38 GHz transitions, one of which is a new detection. We find that 37.7 GHz methanol masers are only associated with the most luminous 6.7 and 12.2 GHz methanol maser sources, which in turn are hypothesized to be the oldest class II methanol sources. We suggest that the 37.7 GHz methanol masers are associated with a brief evolutionary phase (of 1000-4000 years) prior to the cessation of class II methanol maser activity in the associated high-mass star formation region.

  5. Radiation therapy for ocular choroidal neovascularization (phase I/II study)

    International Nuclear Information System (INIS)

    Sasai, Keisuke; Murata, Rumi; Mandai, Michiko; Takahashi, Masayo; Hiraoka, Masahiro

    1996-01-01

    Purpose/Objective: Choroidal neovascularization (CNV) is a major cause of severe loss of visual acuity in some ocular diseases such as age-related macular degeneration (ARMD) and angio-streaks. Laser photocoagulation has been used to treat patients with subfoveal neovascular lesions with well demarcated boundaries. However, the treatment method is usually associated with a large decrease in visual acuity. Therefore, indications for this treatment are very limited. Recently, some investigators reported the effect of low dose irradiation on the subretinal neovascular membranes in CNV. We conducted a phase I/II study to determine the toxicity and efficacy of external photon beam radiotherapy in patients with CNV. Materials and Methods: Between April 1994 and July 1995, 36 patients with choroidal neovascularization (34 with ARMD; 2 with angiostreaks) were treated with radiation therapy. Eligibility criteria for this study were as follows: the eyes had subretinal neovascular membranes in the avascular area of the fovea; the neovascular membranes had grown in size in the last 6 months; the best pretreatment corrected visual acuity was worse than (20(25)); there were no large subretinal hemorrhages causing decrease in visual acuity; patients were 50 years or older and had not received laser photocoagulation nor other treatment for this condition. Written informed consent was obtained from all patients. The patients underwent fluorescein angiographic evaluation and documentation of their neovascular disease prior to irradiation. Fluorescein angiography, measurement of the best corrected visual acuity, ophthalmoscopic and biomicroscopic examinations were performed at 1, 3, 6, and 12 months after treatment. Treatment planning was performed using a CT simulator which enables real-time treatment planning from multiple CT slices. The clinical target volume included the macula and optic disc, which received a dose of 10 Gy/5 fractions/1 week (first 18 eyes) or 20 Gy/10 fractions

  6. Search for the neutrinoless double beta decay (0νββ) of {sup 76}Ge: GERDA Phase II commissioning

    Energy Technology Data Exchange (ETDEWEB)

    Bode, Tobias [Physik-Department E15, Technische Universitaet Muenchen (Germany); Collaboration: GERDA-Collaboration

    2015-07-01

    After successful completion of Phase I the Gerda (Germanium Detector Array) experiment underwent a major upgrade of the experimental apparatus. These upgrades include additional 20 kg of custom-made detectors with improved background rejection capabilities, accompanied by improved front-end electronics and an active liquid argon scintillation light veto. A sensitivity on the neutrinoless double beta decay half-life (T{sub 1/2}{sup 0ν}) of 10{sup 26} yr should be reached after a few years of data taking (Phase II). First results of Phase II commissioning and latest results from Phase I analyses are presented in this talk.

  7. BWR Full Integral Simulation Test (FIST) Phase II test results and TRAC-BWR model qualification

    International Nuclear Information System (INIS)

    Sutherland, W.A.; Alamgir, M.; Findlay, J.A.; Hwang, W.S.

    1985-10-01

    Eight matrix tests were conducted in the FIST Phase I. These tests investigated the large break, small break and steamline break LOCA's, as well as natural circulation and power transients. There are nine tests in Phase II of the FIST program. They include the following LOCA tests: BWR/6 LPCI line break, BWR/6 intermediate size recirculation break, and a BWR/4 large break. Steady state natural circulation tests with feedwater makeup performed at high and low pressure, and at high pressure with HPCS makeup, are included. Simulation of a transient without rod insertion, and with controlled depressurization, was performed. Also included is a simulation of the Peach Bottom turbine trip test. The final two tests simulated a failure to maintain water level during a postulated accident. A FIST program objective is to assess the TRAC code by comparisons with test data. Two post-test predictions made with TRACB04 are compared with Phase II test data in this report. These are for the BWR/6 LPCI line break LOCA, and the Peach Bottom turbine trip test simulation

  8. Predicted Geology of the Pahute Mesa-Oasis Valley Phase II Drilling Initiative

    International Nuclear Information System (INIS)

    2009-01-01

    Pahute Mesa-Oasis Valley (PM-OV) Phase II drilling will occur within an area that encompasses approximately 117 square kilometers (45 square miles) near the center of the Phase I PM-OV hydrostratigraphic framework model area. The majority of the investigation area lies within dissected volcanic terrain between Pahute Mesa on the north and Timber Mountain on the south. This area consists of a complex distribution of volcanic tuff and lava of generally rhyolitic composition erupted from nearby calderas and related vents. Several large buried volcanic structural features control the distribution of volcanic units in the investigation area. The Area 20 caldera, including its structural margin and associated caldera collapse collar, underlies the northeastern portion of the investigation area. The southern half of the investigation area lies within the northwestern portion of the Timber Mountain caldera complex, including portions of the caldera moat and resurgent dome. Another significant structural feature in the area is the west-northwest-trending Northern Timber Mountain moat structural zone, which bisects the northern portion of the investigation area and forms a structural bench. The proposed wells of the UGTA Phase II drilling initiative can be grouped into four generalized volcanic structural domains based on the stratigraphic distribution and structural position of the volcanic rocks in the upper 1,000 meters (3,300 feet) of the crust, a depth that represents the approximate planned total depths of the proposed wells

  9. Turnable Semiconductor Laser Spectroscopy in Hollow Optical Waveguides, Phase II SBIR

    Energy Technology Data Exchange (ETDEWEB)

    Gregory J. Fetzer, Ph.D.

    2001-12-24

    In this study a novel optical trace gas sensor based on a perforated hollow waveguide (PHW) was proposed. The sensor has been given the acronym ESHOW for Environmental Sensor using Hollow Optical Waveguides. Realizations of the sensor have demonstrated rapid response time (<2s), low minimum detection limits (typically around 3 x 10-5 absorbance). Operation of the PHW technology has been demonstrated in the near-infrared (NIR) and mid0infrared (MIR) regions of the spectrum. Simulation of sensor performance provided in depth understanding of the signals and signal processing required to provide high sensitivity yet retain rapid response to gas changes. A dedicated sensor electronics and software foundation were developed during the course of the Phase II effort. Commercial applications of the sensor are ambient air and continuous emissions monitoring, industrial process control and hazardous waste site monitoring. There are numerous other applications for such a sensor including medical diagnosis and treatment, breath analysis for legal purposes, water quality assessment, combustion diagnostics, and chemical process control. The successful completion of Phase II resulted in additional funding of instrument development by the Nations Institute of Heath through a Phase I SBIR grant and a strategic teaming relationship with a commercial manufacture of medical instrumentation. The purpose of the NIH grant and teaming relationship is to further develop the sensor to monitor NO in exhaled breath for the purposes of asthma diagnosis.

  10. Temozolomide and interferon-alpha in metastatic melanoma: a phase II study of the Italian Melanoma Intergroup.

    Science.gov (United States)

    Ridolfi, Ruggero; Romanini, Antonella; Sileni, Vanna Chiarion; Michiara, Maria; Guida, Michele; Biasco, Guido; Poletti, Paola; Amaducci, Laura; Leoni, Maurizio; Ravaioli, Alessandra

    2004-08-01

    Temozolomide (TMZ) is a new oral alkylating agent which has proven to be as active as dacarbazine (DTIC) in the treatment of melanoma, but with a lower toxicity. A multicentric phase II trial was conducted in an out-patient setting to determine the therapeutic activity and safety of TMZ in combination with interferon-alpha (IFN-alpha). From June 2000 to July 2001, 41 patients were recruited to receive TMZ 200 mg/m orally on days 1-5 every 28 days and with 5 MU IFN-alpha subcutaneously three times a week, continuously for eight cycles or until disease progression occurred. Of the 40 treated patients, two complete responses (5%) and three partial responses (7.5%) were observed, with a median duration of 4 months (range, 1.5-13.5 months). Thirteen patients (32.5%) had stable disease for a median of 2.5 months. Time to progression was 2.6 months and the median overall survival was 11.8 months. Nine patients (22.5%) developed brain metastases. The grade 4 toxicity observed in seven patients was of a transient haematological nature. This combination therapy is well tolerated but does not appear to increase the response rate or overall survival with respect to TMZ alone or to chemotherapeutic regimens. Further and more complex associations of these two drugs could be investigated in specific subsets of patients, in particular to evaluate its real efficacy in preventing brain metastases. Copyright 2004 Lippincott Williams & Wilkins

  11. A multicentre phase-II feasibility study evaluating gemcitabine /vinorelbine / prednisolone combination chemotherapy in relapsed / refractory hodgkin's lymphoma

    International Nuclear Information System (INIS)

    Naqi, N.; Ahmad, S.; Shah, I.; Khattak, J.

    2013-01-01

    Objective: To determine the efficacy and toxicity of Gemcitabine, Vinorelbine and Prednisolone (GVP) salvage chemotherapy in relapsed / refractory Hodgkin's Lymphoma (HL). Study Design: A phase-II non-randomized single arm study. Place and Duration of Study: This study was conducted at Combined Military Hospital and Medical College Lahore, Mayo Hospital, King Edward Medical University, Lahore, Allied Hospital, Punjab Medical College, Faisalabad and Combined Military Hospital, Rawalpindi, from January 2007 to December 2007. Methodology: Fifty adult patients with relapsed/refractory HL, adequate marrow reserve, hepatorenal and pulmonary functions, with radiological measurable disease and Karnofsky performance status of 0 - 2 non-candidates for stem cell transplantation, were enrolled. Four 28 days cycles of GVP (Gemcitabine 1000 mg/m2, Vinorelbine 30 mg/m2 on day 1 and 8 intravenously with oral Prednisolone 100 mg/day on day 1 - 5) were given. Response evaluation done according to Cotswolds meeting recommendations and toxicity was evaluated with NCI-CTC (National Cancer Institute - Common Terminology Criteria for adverse events v 3.0). Results: Forty patients completing 4 cycles of GVP, 14 refractory/early relapse and 26 late relapsed (one year postprimary treatment with ABVD) were available for evaluation. The overall response (CRu+PR) rate was 77.5% with better response 85% in late relapsed patients. Haematological toxicity was most common and seen in 70% of cases. Conclusion: GVP is well-tolerated regimen with high response rate and needs to be tested in late relapsed HL. (author)

  12. Phase II trial of 3D-conformal accelerated partial breast irradiation: Lessons learned from patients and physicians’ evaluation

    International Nuclear Information System (INIS)

    Azoury, Fares; Heymann, Steve; Acevedo, Catalina; Spielmann, Marc; Vielh, Philippe; Garbay, Jean-Rémi; Taghian, Alphonse G.; Marsiglia, Hugo; Bourgier, Céline

    2012-01-01

    Introduction: The present study prospectively reported both physicians’ and patients’ assessment for toxicities, cosmetic assessment and patients’ satisfaction after 3D-conformal accelerated partial breast irradiation (APBI). Materials and Methods: From October 2007 to September 2009, 30 early breast cancer patients were enrolled in a 3D-conformal APBI Phase II trial (40 Gy/10 fractions/5 days). Treatment related toxicities and cosmetic results were assessed by both patients and physicians at each visit (at 1, 2, 6 months, and then every 6 months). Patient satisfaction was also scored. Results: After a median follow-up of 27.7 months, all patients were satisfied with APBI treatment, regardless of cosmetic results or late adverse events. Good/excellent cosmetic results were noticed by 80% of patients versus 92% of cases by radiation oncologists. Breast pain was systematically underestimated by physicians (8–20% vs. 16.6–26.2%; Kappa coefficient KC = 0.16–0.44). Grade 1 and 2 fibrosis and/or breast retraction occurred in 7–12% of patients and were overestimated by patients (KC = 0.14–0.27). Conclusions: Present results have shown discrepancies between patient and physician assessments. In addition to the assessment of efficacy and toxicity after 3D-conformal APBI, patients’ cosmetic results consideration and satisfaction should be also evaluated.

  13. A phase II study of V-BEAM as conditioning regimen before second auto-SCT for multiple myeloma.

    Science.gov (United States)

    Wang, T-F; Fiala, M A; Cashen, A F; Uy, G L; Abboud, C N; Fletcher, T; Wu, N; Westervelt, P; DiPersio, J F; Stockerl-Goldstein, K E; Vij, R

    2014-11-01

    High-dose melphalan has been the standard conditioning regimen for auto-SCT in multiple myeloma (MM) for decades. A more effective conditioning regimen may induce deeper responses and longer remission duration. It is especially needed in the setting of second auto-SCT, which rarely achieves comparable results with the first auto-SCT using the same conditioning regimen. Here we conducted a phase II study to investigate the efficacy and safety of a conditioning regimen V-BEAM (bortezomib-BEAM) before second auto-SCT for multiple myeloma. Ten patients were enrolled from September 2012 to May 2013. The CR rate at day +100 after auto-SCT was 75%; all except for one patient remained in remission after a median follow-up of 6 months. Three patients developed Clostridium difficile infection. Two patients died within the first 30 days of auto-SCT from neutropenic colitis and overwhelming sepsis, respectively. Due to the high rate of morbidity and mortality, the study was terminated after 10 patients. In summary, although the conditioning regimen V-BEAM before second auto-SCT for MM provided promising responses, it was associated with unexpected treatment-related toxicity and should not be investigated further without modifications.

  14. Phase II trial of Uracil/Tegafur plus leucovorin and celecoxib combined with radiotherapy in locally advanced pancreatic cancer

    International Nuclear Information System (INIS)

    Morak, Marjolein J.M.; Richel, Dick J.; Eijck, Casper H.J. van; Nuyttens, Joost J.M.E.; Gaast, Ate van der; Vervenne, Walter L.; Padmos, Esther E.; Schaake, Eva E.; Busch, Olivier R.C.; Tienhoven, Geertjan van

    2011-01-01

    Background and purpose: To investigate the efficacy and toxicity of a short intensive Uracil/Tegafur (UFT) based chemoradiotherapy scheme combined with celecoxib in locally advanced pancreatic cancer. Material and methods: The Academic Medical Centre, Amsterdam and the Erasmus Medical Centre, Rotterdam enrolled 83 eligible patients with unresectable pancreatic cancer in a prospective multicentre phase II study. Median age was 62 years, median tumour size 40 mm and the majority of the patients (85%) had pancreatic head cancers. Treatment consisted of 20 x 2.5 Gy radiotherapy combined with UFT 300 mg/m 2 per day, leucovorin (folinic acid) 30 mg and celecoxib 800 mg for 28 days concomitant with radiotherapy. Four patients were lost to follow-up. Results: Full treatment compliance was achieved in 55% of patients, 80% received at least 3 weeks of treatment. No partial or complete response was observed. Median survival was 10.6 months and median time to progression 6.9 months. Toxicity was substantial with 28% grades III and IV gastro-intestinal toxicity and two early toxic deaths. Conclusions: Based on the lack of response, the substantial toxicity of mainly gastro-intestinal origin and the reported mediocre overall and progression free survival, we cannot advise our short intensive chemoradiotherapy schedule combined with celecoxib as the standard treatment.

  15. A phase II study of concomitant boost radiation plus concurrent weekly cisplatin for locally advanced unresectable head and neck carcinomas

    International Nuclear Information System (INIS)

    Medina, Jose Antonio; Rueda, Antonio; Sacchetti de Pasos, Antonio; Contreras, Jorge; Cobo, Manuel; Moreno, Paloma; Benavides, Manuel; Villanueva, Asuncion; Alba, Emilio

    2006-01-01

    Background and purpose: This phase II study evaluated the efficacy and toxicity of weekly cisplatin along with concomitant boost accelerated radiation regimen in patients with locally advanced unresectable head and neck carcinoma. Material and methods: A total of 94 patients (median age, 58 years) with UICC stage III (n=19) and IV (n=75) cancer of the oropharynx, larynx, hypopharynx and oral cavity were included. Patients received radiotherapy with a concomitant boost scheme (1.8 Gy on days 1-40 and 1.5 Gy boost on days 25-40 with a total dose of 72 Gy) and concurrent cisplatin, 40 mg/m 2 weekly, for the first 4 weeks. Results: Most patients (95%) received both radiation and chemotherapy according to protocol. Toxicity was manageable with grade III mucositis and pharyngeal-oesophageal toxicity in 85 and 50% of patients, respectively. Haematological toxicity was mild. Four patients (4%) died due to complications. With a median follow of 41 months, median overall survival and time to progression were 27 and 25 months, respectively. The estimated overall survival at 4 years was 41%. Conclusions: Concomitant boost accelerated radiation plus concurrent weekly cisplatin is a feasible schedule in patients with locally advanced unresectable head and neck carcinoma, with acceptable toxicity and survival data

  16. High Fidelity Down-Conversion Source for Secure Communications using On-Demand Single Photons, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In this NASA SBIR Phase II effort, AdvR will design and build an efficient, fully integrated, waveguide based, source of spectrally uncorrelated photon pairs that...

  17. Process-Hardened, Multi-Analyte Sensor for Characterizing Rocket Plum Constituents Under Test Environment, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — The objective of the Phase II STTR project is to develop a prototype multi-analyte sensor system to detect gaseous analytes present in the test stands during...

  18. Large-Area, Multi-Junction, Epitaxial Lift-Off Solar Cells with Backside Contacts, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — In this Phase II program we propose to develop a manufacturable production process to introduce backside contacts to MicroLink Devices? large-area, multi-junction...

  19. Caltrans WeatherShare Phase II System: An Application of Systems and Software Engineering Process to Project Development

    Science.gov (United States)

    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...

  20. Dualband MW/LW Strained Layer Superlattice Focal Plane Arrays for Satellite-Based Wildfire Detection, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Infrared focal plane arrays (FPAs) based on Type-II strained layer superlattice (SLS) photodiodes have recently experienced significant advances. In Phase I we...