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Sample records for advance-d trial results

  1. 2D vs. 3D imaging in laparoscopic surgery-results of a prospective randomized trial.

    Science.gov (United States)

    Buia, Alexander; Stockhausen, Florian; Filmann, Natalie; Hanisch, Ernst

    2017-12-01

    3D imaging is an upcoming technology in laparoscopic surgery, and recent studies have shown that the modern 3D technique is superior in an experimental setting. However, the first randomized controlled clinical trial in this context dates back to 1998 and showed no significant difference between 2D and 3D visualization using the first 3D generation technique, which is now more than 15 years old. Positive results measured in an experimental setting considering 3D imaging on surgical performance led us to initiate a randomized controlled pragmatic clinical trial to validate our findings in daily clinical routine. Standard laparoscopic operations (cholecystectomy, appendectomy) were preoperatively randomized to a 2D or 3D imaging system. We used a surgical comfort scale (Likert scale) and the Raw NASA Workload TLX for the subjective assessment of 2D and 3D imaging; the duration of surgery was also measured. The results of 3D imaging were statistically significant better than 2D imaging concerning the parameters "own felt safety" and "task efficiency"; the difficulty level of the procedures in the 2D and 3D groups did not differ. Overall, the Raw NASA Workload TLX showed no significance between the groups. 3D imaging could be a possible advantage in laparoscopic surgery. The results of our clinical trial show increased personal felt safety and efficiency of the surgeon using a 3D imaging system. Overall of the procedures, the findings assessed using Likert scales in terms of own felt safety and task efficiency were statistically significant for 3D imaging. The individually perceived workload assessed with the Raw NASA TLX shows no difference. Although these findings are subjective impressions of the performing surgeons without a clear benefit for 3D technology in clinical outcome, we think that these results show the capability that 3D laparoscopy can have a positive impact while performing laparoscopic procedures.

  2. PLANNING PHASE 2 MULTICENTER RANDOMIZED TRIAL OF NEOADJUVANT CHEMO-RADIOTHERAPY FOLLOWED BY D2 GASTRECTOMY AND ADJUVANT CHEMOTHERAPY FOR LOCALLY ADVANCED GASTRIC CANCER

    Directory of Open Access Journals (Sweden)

    V. Yu. Skoropad

    2016-01-01

    Full Text Available Introduction. The prognosis for surgical treatment of locally advanced gastric cancer remains disappointing. Neoadjuvant chemo-radiation therapy is relatively new and the least researched method of treatment, it is attracting more and more attention, mainly abroad in recent years. The aims of neoadjuvant therapy is the earliest start of systemic therapy, damage of the primary tumor and regional metastases, an increase in the percentage of radical operations, improving treatment outcome. Material and methods. The planning study is a multicenter, randomized clinical phase II trial. Patients of the first (experimental group will be treated as the followes: neoadjuvant chemo-radiotherapy (total tumor dose of 46 Gy in 23 fractions with the concurrent modified CapOX scheme followed by D2 gastrectomy and adjuvant chemotherapy. Patients of the second (control group will be treated with D2 gastrectomy and adjuvant chemotherapy. Adjuvant chemotherapy will be carried out under the following schemes (optional for the researchers: CapOX or FOLFOX. Toxicity evaluation of neoadjuvant chemo-radiotherapy and adjuvant chemotherapy will be conducted with NCI CTC Toxicity Scale Version 3.0. The main objectives of the trial are to assess the safety and immediate effectiveness of neoadjuvant chemo-radiotherapy according to the criteria of the frequency and severity of postoperative complications and mortality, and tumor response. We are planning to include 80 patients with morphologically confirmed gastric cancer сT2–4N1–3, сT3–4N0–3; М0. The proposed trial will be carried out in accordance with the principles of the Helsinki Declaration, it has been approved by local ethic committees of the participated institutions. Results. As a result of this multicenter randomized trial it is planned to show the reproducibility of obtained in MRRC and a number of foreign centers results – that is, the safety and high immediate effectiveness of neoadjuvant chemo

  3. The Effect of Treatment Advances on the Mortality Results of Breast Cancer Screening Trials: A Microsimulation Model.

    Science.gov (United States)

    Birnbaum, Jeanette; Gadi, Vijayakrishna K; Markowitz, Elan; Etzioni, Ruth

    2016-02-16

    Mammography trials, which are the primary sources of evidence for screening benefit, were conducted decades ago. Whether advances in systemic therapies have rendered previously observed benefits of screening less significant is unknown. To compare the outcomes of breast cancer screening trials had they been conducted using contemporary systemic treatments with outcomes of trials conducted with previously used treatments. Computer simulation model of 3 virtual screening trials with similar reductions in advanced-stage cancer cases but reflecting treatment patterns in 1975 (prechemotherapy era), 1999, or 2015 (treatment according to receptor status). Meta-analyses of screening and treatment trials; study of dissemination of primary systemic treatments; SEER (Surveillance, Epidemiology, and End Results) registry. U.S. women aged 50 to 74 years. 10 and 25 years. Population. Mammography, chemotherapy, tamoxifen, aromatase inhibitors, and trastuzumab. Breast cancer mortality rate ratio (MRR) and absolute risk reduction (ARR) obtained by the difference in cumulative breast cancer mortality between control and screening groups. At 10 years, screening in a 1975 trial yielded an MRR of 90% and an ARR of 5 deaths per 10,000 women. A 2015 screening trial yielded a 10-year MRR of 90% and an ARR of 3 deaths per 10,000 women. Greater reductions in advanced-stage disease yielded a greater screening effect, but MRRs remained similar across trials. However, ARRs were consistently lower under contemporary treatments. When contemporary treatments were available only for early-stage cases, the MRR was 88%. Disease models simplify reality and cannot capture all breast cancer subtypes. Advances in systemic therapies for breast cancer have not substantively reduced the relative benefits of screening but have likely reduced the absolute benefits because of their positive effect on breast cancer survival. University of Washington and National Cancer Institute.

  4. Heterogeneous FDG-guided dose-escalation for locally advanced NSCLC (the NARLAL2 trial): Design and early dosimetric results of a randomized, multi-centre phase-III study

    DEFF Research Database (Denmark)

    Møller, Ditte Sloth; Nielsen, Tine Bjørn; Brink, Carsten

    2017-01-01

    Background and purpose: Local recurrence is frequent in locally advanced NSCLC and is primarily located in FDG-avid parts of tumour and lymph nodes. Aiming at improving local control without increasing toxicity, we designed a multi-centre phase-III trial delivering inhomogeneous dose-escalation d......Background and purpose: Local recurrence is frequent in locally advanced NSCLC and is primarily located in FDG-avid parts of tumour and lymph nodes. Aiming at improving local control without increasing toxicity, we designed a multi-centre phase-III trial delivering inhomogeneous dose...

  5. Cabozantinib Versus Everolimus in Patients with Advanced Renal Cell Carcinoma: Results of a Randomised Phase III Trial (METEOR

    Directory of Open Access Journals (Sweden)

    Toni Choueiri

    2015-11-01

    Full Text Available The METEOR trial of cabozantinib versus everolimus in advanced renal cell carcinoma (RCC was reported by Prof Choueiri at the European Cancer Congress 2015. This presentation follows the publication in the New England Journal of Medicine of the METEOR trial back-to-back with the CheckMate 025 trial of nivolumab versus everolimus in the same patient setting. Excitingly, these trials demonstrated, for the first time, significant benefits over the standard of care for heavily pre-treated patients with advanced RCC. Cabozantinib, an oral multi-targeted tyrosine kinase inhibitor (TKI aims to address the challenge of resistance to targeted therapy with TKIs. While the METEOR trial has not yet reached its final analysis of overall survival (OS, the clear progression-free survival (PFS benefit, acceptable safety profile, and similar tolerability to other TKIs shown by cabozantinib indicate that this represents a promising new treatment option for second-line or subsequent therapy for patients with advanced RCC.

  6. Design, history and results of the Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) randomised controlled trial

    DEFF Research Database (Denmark)

    Punthakee, Z; Bosch, J; Dagenais, G

    2012-01-01

    AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit......AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs...

  7. Laparoscopy Assisted versus Open Distal Gastrectomy with D2 Lymph Node Dissection for Advanced Gastric Cancer: Design and Rationale of a Phase II Randomized Controlled Multicenter Trial (COACT 1001).

    Science.gov (United States)

    Nam, Byung Ho; Kim, Young-Woo; Reim, Daniel; Eom, Bang Wool; Yu, Wan Sik; Park, Young Kyu; Ryu, Keun Won; Lee, Young Joon; Yoon, Hong Man; Lee, Jun Ho; Jeong, Oh; Jeong, Sang Ho; Lee, Sang Eok; Lee, Sang Ho; Yoon, Ki Young; Seo, Kyung Won; Chung, Ho Young; Kwon, Oh Kyoung; Kim, Tae Bong; Lee, Woon Ki; Park, Seong Heum; Sul, Ji-Young; Yang, Dae Hyun; Lee, Jong Seok

    2013-09-01

    Laparoscopy-assisted distal gastrectomy for early gastric cancer has gained acceptance and popularity worldwide. However, laparoscopy-assisted distal gastrectomy for advanced gastric cancer is still controversial. Therefore, we propose this prospective randomized controlled multi-center trial in order to evaluate the safety and feasibility of laparoscopy assisted D2-gastrectomy for advanced stage gastric cancer. Patients undergoing distal gastrectomy for advanced gastric cancer staged cT2/3/4 cN0/1/2/3a cM0 by endoscopy and computed tomography are eligible for enrollment after giving their informed consent. Patients will be randomized either to laparoscopy-assisted distal gastrectomy or open distal gastrectomy. Sample size calculation revealed that 102 patients are to be included per treatment arm. The primary endpoint is the non-compliance rate of D2 dissection; relevant secondary endpoints are three-year disease free survival, surgical and postoperative complications, hospital stay and unanimity rate of D2 dissection evaluated by reviewing the intraoperative video documentation. Oncologic safety is the major concern regarding laparoscopy-assisted distal gastrectomy for advanced gastric cancer. Therefore, the non-compliance rate of clearing the N2 area was chosen as the most important parameter for the technical feasibility of the laparoscopic procedure. Furthermore, surgical quality will be carefully reviewed, that is, three independent experts will review the video records and score with a check list. For a long-term result, disease free survival is considered a secondary endpoint for this trial. This study will offer promising evidence of the feasibility and safety of Laparoscopy-assisted distal gastrectomy for advanced gastric cancer. NCT01088204 (international), NCCCTS-09-448 (Korea).

  8. Advanced resin systems and 3D textile preforms for low cost composite structures

    Science.gov (United States)

    Shukla, J. G.; Bayha, T. D.

    1993-01-01

    Advanced resin systems and 3D textile preforms are being evaluated at Lockheed Aeronautical Systems Company (LASC) under NASA's Advanced Composites Technology (ACT) Program. This work is aimed towards the development of low-cost, damage-tolerant composite fuselage structures. Resin systems for resin transfer molding and powder epoxy towpreg materials are being evaluated for processability, performance and cost. Three developmental epoxy resin systems for resin transfer molding (RTM) and three resin systems for powder towpregging are being investigated. Various 3D textile preform architectures using advanced weaving and braiding processes are also being evaluated. Trials are being conducted with powdered towpreg, in 2D weaving and 3D braiding processes for their textile processability and their potential for fabrication in 'net shape' fuselage structures. The progress in advanced resin screening and textile preform development is reviewed here.

  9. First results on fast wave current drive in advanced tokamak discharges in DIII-D

    International Nuclear Information System (INIS)

    Prater, R.; Cary, W.P.; Baity, F.W.

    1995-07-01

    Initial experiments have been performed on the DIII-D tokamak on coupling, direct electron heating, and current drive by fast waves in advanced tokamak discharges. These experiments showed efficient central heating and current drive in agreement with theory in magnitude and profile. Extrapolating these results to temperature characteristic of a power plant (25 keV) gives current drive efficiency of about 0.3 MA/m 2

  10. Efficacy of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer: the protocol of the KLASS-02 multicenter randomized controlled clinical trial

    International Nuclear Information System (INIS)

    Hur, Hoon; Lee, Hyun Yong; Lee, Hyuk-Joon; Kim, Min Chan; Hyung, Woo Jin; Park, Young Kyu; Kim, Wook; Han, Sang-Uk

    2015-01-01

    Despite the well-described benefits of laparoscopic surgery such as lower operative blood loss and enhanced postoperative recovery in gastric cancer surgery, the application of laparoscopic surgery in patients with locally advanced gastric cancer (AGC) remains elusive owing to a lack of clinical evidence. Recently, the Korean Laparoscopic Surgical Society Group launched a new multicenter randomized clinical trial (RCT) to compare laparoscopic and open D2 lymphadenectomy for patients with locally AGC. Here, we introduce the protocol of this clinical trial. This trial is an investigator-initiated, randomized, controlled, parallel group, non-inferiority trial. Gastric cancer patients diagnosed with primary tumors that have invaded into the muscle propria and not into an adjacent organ (cT2–cT4a) in preoperative studies are recruited. Another criterion for recruitment is no lymph node metastasis or limited perigastric lymph node (including lymph nodes around the left gastric artery) metastasis. A total 1,050 patients in both groups are required to statistically show non-inferiority of the laparoscopic approach with respect to the primary end-point, relapse-free survival of 3 years. Secondary outcomes include postoperative morbidity and mortality, postoperative recovery, quality of life, and overall survival. Surgeons who are validated through peer-review of their surgery videos can participate in this clinical trial. This clinical trial was designed to maintain the principles of a surgical clinical trial with internal validity for participating surgeons. Through the KLASS-02 RCT, we hope to show the efficacy of laparoscopic D2 lymphadenectomy in AGC patients compared with the open procedure. ClinicalTrial.gov, https://www.clinicaltrials.gov/ct2/show/NCT01456598?term

  11. Implications of HIV PrEP Trials Results

    Science.gov (United States)

    Anton, Peter; Fletcher, Courtney V.; DeGruttola, Victor; McGowan, Ian; Becker, Stephen; Zwerski, Sheryl; Burns, David

    2011-01-01

    Abstract Six randomized clinical trials have been implemented to examine the efficacy of tenofovir disoproxil fumarate (TDF) and/or TDF/emtricitabine (TDF/FTC) as preexposure prophylaxis for HIV-1 infection (PrEP). Although largely complementary, the six trials have many similar features. As the earliest results become available, an urgent question may arise regarding whether changes should be made in the conduct of the other trials. To consider this in advance, a Consultation on the Implications of HIV Pre-Exposure Prophylaxis (PrEP) Trials Results sponsored by the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), and the Bill and Melinda Gates Foundation (BMGF) was held on January 29, 2010, at the Natcher Conference Center, NIH, Bethesda, MD. Participants included basic scientists, clinical researchers (including investigators performing the current PrEP trials), and representatives from the U.S. Food and Drug Administration (FDA) and the agencies sponsoring the trials: the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Agency for International Development (USAID), the BMGF, and the U.S. NIH. We report here a summary of the presentations and highlights of salient discussion topics from this workshop. PMID:20969483

  12. Fifteen-year results of a randomized prospective trial of hyperfractionated chest wall irradiation versus once-daily chest wall irradiation after chemotherapy and mastectomy for patients with locally advanced noninflammatory breast cancer

    International Nuclear Information System (INIS)

    Buchholz, Thomas A.; Strom, Eric A.; Oswald, Mary Jane; Perkins, George H.; Oh, Julia; Domain, Delora; Yu, Tse-Kuan; Woodward, Wendy A.; Tereffe, Welela; Singletary, S. Eva; Thomas, Eva; Buzdar, Aman U.; Hortobagyi, Gabriel N.; McNeese, Marsha D.

    2006-01-01

    Purpose: To analyze the results of a Phase III clinical trial that investigated whether a hyperfractionated radiotherapy (RT) schedule could reduce the risk of locoregional recurrence in patients with locally advanced breast cancer treated with chemotherapy and mastectomy. Methods and Materials: Between 1985 and 1989, 200 patients with clinical Stage III noninflammatory breast cancer were enrolled in a prospective study investigating neoadjuvant and adjuvant chemotherapy. Of the 179 patients treated with mastectomy after neoadjuvant chemotherapy, 108 participated in a randomized component of the trial that compared a dose-escalated, hyperfractionated (twice-daily, b.i.d.) chest wall RT schedule (72 Gy in 1.2-Gy b.i.d. fractions) with a once-daily (q.d.) schedule (60 Gy in 2-Gy q.d. fractions). In both arms of the study, the supraclavicular fossa and axillary apex were treated once daily to 50 Gy. The median follow-up period was 15 years. Results: The 15-year actuarial locoregional recurrence rate was 7% for the q.d. arm and 12% for the b.i.d. arm (p = 0.36). The rates of severe acute toxicity were similar (4% for q.d. vs. 5% for b.i.d.), but moist desquamation developed in 42% of patients in the b.i.d. arm compared with 28% of the patients in the q.d. arm (p = 0.16). The 15-year actuarial rate of severe late RT complications did not differ between the two arms (6% for q.d. vs. 11% for b.i.d., p = 0.54). Conclusion: Although the sample size of this study was small, we found no evidence that this hyperfractionation schedule of postmastectomy RT offered a clinical advantage. Therefore, we have concluded that it should not be further studied in this cohort of patients

  13. Analysis of the PISC II trials results

    International Nuclear Information System (INIS)

    Haines, N.

    1988-01-01

    The paper presents the analysis scheme of the Programme for the Inspection of Steel Components PISC II trial results. The objective of the PISC II exercise is to evaluate the effectiveness of current and advanced NDT techniques for inspection of reactor pressure vessel components. The analysis scheme takes data from the Round Robin Trial (RRT) and Destructive Examination, then reduces it to a manageable form in order to present useful conclusions on the effectiveness of NDT. A description is given of the data provided by RRT, the data analysis scheme, the definition of analysis parameters, and the main methods of data presentation. (U.K.)

  14. Mandibular advancement appliance for obstructive sleep apnoea: results of a randomised placebo controlled trial using parallel group design

    DEFF Research Database (Denmark)

    Petri, N.; Svanholt, P.; Solow, B.

    2008-01-01

    The aim of this trial was to evaluate the efficacy of a mandibular advancement appliance (MAA) for obstructive sleep apnoea (OSA). Ninety-three patients with OSA and a mean apnoea-hypopnoea index (AHI) of 34.7 were centrally randomised into three, parallel groups: (a) MAA; (b) mandibular non......). Eighty-one patients (87%) completed the trial. The MAA group achieved mean AHI and Epworth scores significantly lower (P group and the no-intervention group. No significant differences were found between the MNA group and the no-intervention group. The MAA group had...

  15. Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

    Science.gov (United States)

    Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

    2015-01-01

    In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

  16. Morbidity and Mortality of Laparoscopic Versus Open D2 Distal Gastrectomy for Advanced Gastric Cancer: A Randomized Controlled Trial.

    Science.gov (United States)

    Hu, Yanfeng; Huang, Changming; Sun, Yihong; Su, Xiangqian; Cao, Hui; Hu, Jiankun; Xue, Yingwei; Suo, Jian; Tao, Kaixiong; He, Xianli; Wei, Hongbo; Ying, Mingang; Hu, Weiguo; Du, Xiaohui; Chen, Pingyan; Liu, Hao; Zheng, Chaohui; Liu, Fenglin; Yu, Jiang; Li, Ziyu; Zhao, Gang; Chen, Xinzu; Wang, Kuan; Li, Ping; Xing, Jiadi; Li, Guoxin

    2016-04-20

    The safety and efficacy of radical laparoscopic distal gastrectomy (LG) with D2 lymphadenectomy for the treatment of advanced gastric cancer (AGC) remain controversial. We conducted a randomized controlled trial to compare laparoscopic and conventional open distal gastrectomy with D2 lymph node dissections for AGC. Between September 2012 and December 2014, 1,056 patients with clinical stage T2-4aN0-3M0 gastric cancer were eligible for inclusion. They were randomly assigned to either the LG with D2 lymphadenectomy group (n = 528) or the open gastrectomy (OG) with D2 lymphadenectomy group (n = 528). Fifteen experienced surgeons from 14 institutions in China participated in the study. The morbidity and mortality within 30 days after surgery between the LG (n = 519) and the OG (n = 520) groups were compared on the basis of the modified intention-to-treat principle. Postoperative complications were stratified according to the Clavien-Dindo classification. The compliance rates of D2 lymphadenectomy were similar between the LG and OG groups (99.4% v 99.6%; P = .845). The postoperative morbidity was 15.2% in the LG group and 12.9% in OG group with no significant difference (difference, 2.3%; 95% CI, -1.9 to 6.6; P = .285). The mortality rate was 0.4% for the LG group and zero for the OG group (difference, 0.4%; 95% CI, -0.4 to 1.4; P = .249). The distribution of severity was similar between the two groups (P = .314). Experienced surgeons can safely perform LG with D2 lymphadenectomy for AGC. © 2016 by American Society of Clinical Oncology.

  17. First-in-Human Phase 1 Trial of Agarose Beads Containing Murine RENCA Cells in Advanced Solid Tumors

    Directory of Open Access Journals (Sweden)

    Barry H. Smith

    2016-01-01

    Full Text Available Purpose Agarose macrobeads containing mouse renal adenocarcinoma cells (RMBs release factors, suppressing the growth of cancer cells and prolonging survival in spontaneous or induced tumor animals, mediated, in part, by increased levels of myocyte-enhancing factor (MEF2D via EGFR-and AKT-signaling pathways. The primary objective of this study was to determine the safety of RMBs in advanced, treatment-resistant metastatic cancers, and then its efficacy (survival, which is the secondary objective. Methods Thirty-one patients underwent up to four intraperitoneal implantations of RMBs (8 or 16 macrobeads/kg via laparoscopy in this single-arm trial (FDA BB-IND 10091; NCT 00283075. Serial physical examinations, laboratory testing, and PET-CT imaging were performed before and three months after each implant. Results RMBs were well tolerated at both dose levels (mean 660.9 per implant. AEs were (Grade 1/2 with no treatment-related SAEs. Conclusion The data support the safety of RMB therapy in advanced-malignancy patients, and the preliminary evidence for their potential efficacy is encouraging. A Phase 2 efficacy trial is ongoing.

  18. Simvastatin Does Not Affect Vitamin D Status, but Low Vitamin D Levels Are Associated with Dyslipidemia: Results from a Randomised, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Lars Rejnmark

    2010-01-01

    Full Text Available Objectives. Statin drugs act as inhibitors of the 3-hydroxy-3methylglutaryl coenzyme A (HMG-CoA reductase enzyme early in the mevalonate pathway, thereby reducing the endogenous cholesterol synthesis. In recent studies, it has been suggested from epidemiological data that statins also may improve vitamin D status, as measured by increased plasma 25-hydroxyvitamin D (25OHD levels. We now report the results from a randomised controlled trial on effects of simvastatin on plasma 25OHD levels. Design and Methods. We randomised 82 healthy postmenopausal women to one year of treatment with either simvastatin 40 mg/d or placebo and performed measurement at baseline and after 26 and 52 weeks of treatment. The study was completed by 77 subjects. Results. Compared with placebo, plasma levels of cholesterol and low-density lipoproteins decreased in response to treatment with simvastatin, but our study showed no effect of simvastatin on vitamin D status. However, plasma levels of triglycerides were inversely associated with tertiles of plasma 25OHD levels and changes in plasma triglycerides levels correlated inversely with seasonal changes in vitamin D status. Conclusion. Our data do not support a pharmacological effect of statins on vitamin D status, but do suggest that vitamin D may influence plasma lipid profile and thus be of importance to cardiovascular health.

  19. WE-AB-BRA-07: Quantitative Evaluation of 2D-2D and 2D-3D Image Guided Radiation Therapy for Clinical Trial Credentialing, NRG Oncology/RTOG

    Energy Technology Data Exchange (ETDEWEB)

    Giaddui, T; Yu, J; Xiao, Y [Thomas Jefferson University, Philadelphia, PA (United States); Jacobs, P [MIM Software, Inc, Cleavland, Ohio (United States); Manfredi, D; Linnemann, N [IROC Philadelphia, RTQA Center, Philadelphia, PA (United States)

    2015-06-15

    Purpose: 2D-2D kV image guided radiation therapy (IGRT) credentialing evaluation for clinical trial qualification was historically qualitative through submitting screen captures of the fusion process. However, as quantitative DICOM 2D-2D and 2D-3D image registration tools are implemented in clinical practice for better precision, especially in centers that treat patients with protons, better IGRT credentialing techniques are needed. The aim of this work is to establish methodologies for quantitatively reviewing IGRT submissions based on DICOM 2D-2D and 2D-3D image registration and to test the methodologies in reviewing 2D-2D and 2D-3D IGRT submissions for RTOG/NRG Oncology clinical trials qualifications. Methods: DICOM 2D-2D and 2D-3D automated and manual image registration have been tested using the Harmony tool in MIM software. 2D kV orthogonal portal images are fused with the reference digital reconstructed radiographs (DRR) in the 2D-2D registration while the 2D portal images are fused with DICOM planning CT image in the 2D-3D registration. The Harmony tool allows alignment of the two images used in the registration process and also calculates the required shifts. Shifts calculated using MIM are compared with those submitted by institutions for IGRT credentialing. Reported shifts are considered to be acceptable if differences are less than 3mm. Results: Several tests have been performed on the 2D-2D and 2D-3D registration. The results indicated good agreement between submitted and calculated shifts. A workflow for reviewing these IGRT submissions has been developed and will eventually be used to review IGRT submissions. Conclusion: The IROC Philadelphia RTQA center has developed and tested a new workflow for reviewing DICOM 2D-2D and 2D-3D IGRT credentialing submissions made by different cancer clinical centers, especially proton centers. NRG Center for Innovation in Radiation Oncology (CIRO) and IROC RTQA center continue their collaborative efforts to enhance

  20. WE-AB-BRA-07: Quantitative Evaluation of 2D-2D and 2D-3D Image Guided Radiation Therapy for Clinical Trial Credentialing, NRG Oncology/RTOG

    International Nuclear Information System (INIS)

    Giaddui, T; Yu, J; Xiao, Y; Jacobs, P; Manfredi, D; Linnemann, N

    2015-01-01

    Purpose: 2D-2D kV image guided radiation therapy (IGRT) credentialing evaluation for clinical trial qualification was historically qualitative through submitting screen captures of the fusion process. However, as quantitative DICOM 2D-2D and 2D-3D image registration tools are implemented in clinical practice for better precision, especially in centers that treat patients with protons, better IGRT credentialing techniques are needed. The aim of this work is to establish methodologies for quantitatively reviewing IGRT submissions based on DICOM 2D-2D and 2D-3D image registration and to test the methodologies in reviewing 2D-2D and 2D-3D IGRT submissions for RTOG/NRG Oncology clinical trials qualifications. Methods: DICOM 2D-2D and 2D-3D automated and manual image registration have been tested using the Harmony tool in MIM software. 2D kV orthogonal portal images are fused with the reference digital reconstructed radiographs (DRR) in the 2D-2D registration while the 2D portal images are fused with DICOM planning CT image in the 2D-3D registration. The Harmony tool allows alignment of the two images used in the registration process and also calculates the required shifts. Shifts calculated using MIM are compared with those submitted by institutions for IGRT credentialing. Reported shifts are considered to be acceptable if differences are less than 3mm. Results: Several tests have been performed on the 2D-2D and 2D-3D registration. The results indicated good agreement between submitted and calculated shifts. A workflow for reviewing these IGRT submissions has been developed and will eventually be used to review IGRT submissions. Conclusion: The IROC Philadelphia RTQA center has developed and tested a new workflow for reviewing DICOM 2D-2D and 2D-3D IGRT credentialing submissions made by different cancer clinical centers, especially proton centers. NRG Center for Innovation in Radiation Oncology (CIRO) and IROC RTQA center continue their collaborative efforts to enhance

  1. Concurrent chemoradiotherapy for locally advanced lung carcinoma: present results and future prospects

    International Nuclear Information System (INIS)

    Reboul, F.; Vincent, P.; Brewer, Y.; Taulelle, M.

    1997-01-01

    The prognosis of locally advanced lung cancer is reportedly poor in all histologic types. In non-small cell lung cancer, radiation therapy alone results in disappointing long-term survival. Three recent randomized trials, however, have shown a limited but significant improvement of survival with induction chemotherapy, though local control remained poor in these studies as well as in small-cell lung cancer treated with chemotherapy and late radiotherapy. Tow randomized trials focusing on small-cell lung cancer have recently shown significant benefit due to the combination of early concurrent mediastinal irradiation and chemotherapy, with major improvement in local control and a more than 40% 2-year survival rate. The concept of concurrent chemoradiotherapy has also been studied in non-small cell carcinoma with several pilot studies leading to both encouraging results and improved survival rate (up to 40% at 2 years). Ongoing phase III trials are comparing sequential versus concurrent chemoradiotherapy and will define the role of radical surgery after chemoradiotherapy in locally advanced non-small cell lung cancer. (authors)

  2. Interim PET Response-adapted Strategy in Untreated Advanced Stage Hodgkin Lymphoma: Results of GOELAMS LH 2007 Phase 2 Multicentric Trial.

    Science.gov (United States)

    Carras, Sylvain; Dubois, Benjamin; Senecal, Delphine; Jais, Jean-Philippe; Peoc'h, Michel; Quittet, Philippe; Foussard, Charles; Bouabdallah, Krimo; Gastinne, Thomas; Jourdan, Eric; Sanhes, Laurence; Ertault, Marjan; Lamy, Thierry; Molina, Lysiane

    2018-03-01

    Patients with advanced stage Hodgkin lymphoma still present unsatisfactory outcomes. The Groupe d'étude des Leucémies Aigues et des Maladies du Sang (GOELAMS) group conducted a prospective multicentric trial (NCT00920153) for advanced stage Hodgkin lymphoma to evaluate a positron emission tomography (PET)-adapted strategy. Patients received an intensive regimen (VABEM [vindesine, doxorubicin, carmustine, etoposide, and methylprednisolone]) in front-line and interim 18F FDG-PET evaluation after 2 courses (PET-2). Patients with negative PET-2 findings received 1 additional course. Patients with positive PET-2 findings underwent early salvage therapy followed by high-dose therapy/autologous stem cell transplantation. Fifty-one patients were included. The final complete remission rate was 88%. With a median follow up of 5.3 years, 5-year event-free survival and overall survival rates were 75.3% and 85.3%, respectively, for the whole cohort. Patients who were PET-2-negative had 5-year event-free survival and overall survival rates of, respectively, 77.8% and 88.2% versus 85.1% and 91.7% for patients who were PET-2-positive. A PET-guided strategy with early salvage therapy and high-dose therapy/autologous stem cell transplantation for patients with interim PET-2-positive findings is safe and feasible and provide similar outcome as patients with a negative PET-2. Copyright © 2018 Elsevier Inc. All rights reserved.

  3. Bone mineral density during pregnancy in women participating in a randomized controlled trial of vitamin D supplementation.

    Science.gov (United States)

    Wei, Wei; Shary, Judith R; Garrett-Mayer, Elizabeth; Anderson, Betsy; Forestieri, Nina E; Hollis, Bruce W; Wagner, Carol L

    2017-12-01

    Background: Little is known about bone mineral density (BMD) during pregnancy. Advances in technology with lower radiation emissions by dual-energy X-ray absorptiometry instruments now permit the safe measurement of BMD during pregnancy. Objective: We evaluated maternal BMD during pregnancy as a function of vitamin D status in women of diverse racial/ethnic backgrounds. Design: A total of 301 women who underwent BMD measurements at 12-20 wk of gestation and again at 0-14 wk postpartum were included in this analysis. Women were a subset of subjects who were recruited for a randomized, controlled, double-blind trial of vitamin D supplementation in pregnancy (400, 2000, or 4000 IU/d). Results: Treatment had no significant effect on changes in BMD that occurred between 12-20 wk of gestation and 0-14 wk postpartum. Similarly, changes in spine and femoral neck bone mineral contents (BMCs) were not significantly different in the treatment groups. In addition, vitamin D inadequacy (serum 25-hydroxyvitamin D concentration, averaged across pregnancy, vitamin D supplementation on bone health and suggest that race/ethnicity and BMI play an important role in pregnancy bone health. This trial was registered at clinicaltrials.gov as NCT00292591. © 2017 American Society for Nutrition.

  4. Results of an Oncology Clinical Trial Nurse Role Delineation Study.

    Science.gov (United States)

    Purdom, Michelle A; Petersen, Sandra; Haas, Barbara K

    2017-09-01

    To evaluate the relevance of a five-dimensional model of clinical trial nursing practice in an oncology clinical trial nurse population. 
. Web-based cross-sectional survey.
. Online via Qualtrics.
. 167 oncology nurses throughout the United States, including 41 study coordinators, 35 direct care providers, and 91 dual-role nurses who provide direct patient care and trial coordination.
. Principal components analysis was used to determine the dimensions of oncology clinical trial nursing practice.
. Self-reported frequency of 59 activities.
. The results did not support the original five-dimensional model of nursing care but revealed a more multidimensional model.
. An analysis of frequency data revealed an eight-dimensional model of oncology research nursing, including care, manage study, expert, lead, prepare, data, advance science, and ethics.
. This evidence-based model expands understanding of the multidimensional roles of oncology nurses caring for patients with cancer enrolled in clinical trials.

  5. Comparison of long-term results between laparoscopy-assisted gastrectomy and open gastrectomy with D2 lymph node dissection for advanced gastric cancer.

    Science.gov (United States)

    Hamabe, Atsushi; Omori, Takeshi; Tanaka, Koji; Nishida, Toshirou

    2012-06-01

    Laparoscopy-assisted gastrectomy (LAG) has been established as a low-invasive surgery for early gastric cancer. However, it remains unknown whether it is applicable also for advanced gastric cancer, mainly because the long-term results of LAG with D2 lymph node dissection for advanced gastric cancer have not been well validated compared with open gastrectomy (OG). A retrospective cohort study was performed to compare LAG and OG with D2 lymph node dissection. For this study, 167 patients (66 LAG and 101 OG patients) who underwent gastrectomy with D2 lymph node dissection for advanced gastric cancer were reviewed. Recurrence-free survival and overall survival time were estimated using Kaplan-Meier curves. Stratified log-rank statistical evaluation was used to compare the difference between the LAG and OG groups stratified by histologic type, pathologic T status, N status, and postoperative adjuvant chemotherapy. The adjusted Cox proportional hazards regression models were used to calculate the hazard ratios (HRs) of LAG. The 5-year recurrence-free survival rate was 89.6% in the LAG group and 75.8% in the OG group (nonsignificant difference; stratified log-rank statistic, 3.11; P = 0.0777). The adjusted HR of recurrence for LAG compared with OG was 0.389 [95% confidence interval (CI) 0.131-1.151]. The 5-year overall survival rate was 94.4% in the LAG group and 78.5% in the OG group (nonsignificant difference; stratified log-rank statistic, 0.4817; P = 0.4877). The adjusted HR of death for LAG compared with OG was 0.633 (95% CI 0.172-2.325). The findings show that LAG with D2 lymph node dissection is acceptable in terms of long-term results for advanced gastric cancer cases and may be applicable for advanced gastric cancer treatment.

  6. 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.

  7. Does the Addition of Cetuximab to Radiochemotherapy Improve Outcome of Patients with Locally Advanced Rectal Cancer? Long-Term Results from Phase II Trials

    Directory of Open Access Journals (Sweden)

    M. Kripp

    2015-01-01

    Full Text Available Purpose. The addition of cetuximab to radiochemotherapy (RCT failed to improve complete response rates in locally advanced rectal cancer (LARC. We report the long-term results in patients treated within two sequential clinical trials. Methods. Patients receiving neoadjuvant RCT using capecitabine and irinotecan (CapIri within a phase I/II trial or CapIri + cetuximab within a phase II trial were evaluated for analysis of disease-free survival (DFS and overall survival (OS. KRAS exon 2 mutational status had been analyzed in patients receiving cetuximab. Results. 37 patients from the CapIri trial and 49 patients from the CapIri-cetuximab treatment group were evaluable. Median follow-up time was 75.2 months. The 5-year DFS rate was 82% (CapIri and 79% (CapIri-cetuximab (P=0.62. The median OS was 127.4 months. 5-year OS was 73% for both groups (CapIri and CapIri-cetuximab (P=0.61. No significant difference in DFS (P=0.86 or OS (P=0.39 was noticed between patients receiving CapIri and those receiving CapIri-cetuximab with KRAS wild-type tumors. Conclusions. As the addition of cetuximab did not improve neither DFS nor OS it should not play a role in the perioperative treatment of patients with LARC, not even of patients with (KRAS WT tumors.

  8. Quality Assurance Issues in Conducting Multi-Institutional Advanced Technology Clinical Trials

    International Nuclear Information System (INIS)

    Purdy, James A.

    2008-01-01

    The National Cancer Institute-sponsored Advanced Technology Quality Assurance (QA) Consortium, which consisted of the Image-Guided Therapy QA Center, Radiation Therapy Oncology Group, Radiological Physics Center, Quality Assurance Review Center, and Resource Center for Emerging Technologies, has pioneered the development of an infrastructure and QA method for advanced technology clinical trials that requires volumetric digital data submission of a protocol patient's treatment plan and verification data. In particular, the Image-Guided Therapy QA Center has nearly 15 years experience in facilitating QA review for Radiation Therapy Oncology Group advanced technology clinical trials. This QA process includes (1) a data integrity review for completeness of protocol required elements, the format of data, and possible data corruption, and recalculation of dose-volume histograms; (2) a review of compliance with target volume and organ-at-risk contours by study chairs; and (3) a review of dose prescription and dose heterogeneity compliance by the Radiation Therapy Oncology Group Headquarters Dosimetry Group or the Radiological Physics Center dosimetrists (for brachytherapy protocols). This report reviews the lessons learned and the QA challenges presented by the use of advanced treatment modalities in clinical trials requiring volumetric digital data submission

  9. Results of trial operation of the WWER advanced fuel assemblies

    International Nuclear Information System (INIS)

    Vasilchenko, I.; Dragunov, Y.; Mikhalchuk, A.

    2001-01-01

    The paper describes results from experimental operation of advanced WWER-1000 fuel assemblies (AFA) at five units in Balakovo NPP. Advanced fuel is developed according to the concept of standard WWER-1000 fuel assembly (jacket-free). The new features includes: 1) zirconium guiding channels (alloy E-635 and E-110) and spacer grids (alloy E-110); 2) integrated burnable absorber gadolinium; 3) extended service life of fuel assemblies (FA) and absorber rods (possibility of repair of FA); 4) improved adoption to reactor conditions. Some results of AFA pilot operation of a three year operation are presented and analyses of effectiveness of improvements are made concerning application of zirconium channels and grids; application of integrated burnable absorbers; extension of FA and absorbing rods service life and FA repairability. These new features of WWER-1000 fuel design allow: 1) to reduce the average fuel enrichment to the 3.77% instead of 4.31% in U-235; 2) to reduce the FA axial load in reactor hot state by 40%,; 3) increasing of fuel operation in reactor to the 30000 effective days with possibility to have a 5-year residence time in the reactor. The design of new generation FA for WWER-440 reactors involves few key changes. Fuel inventory in new fuel design is increased due to elongation of fuel stack and reducing the diameter of the central hole. Vibration stability is enhanced as a result of: no-play junction of the fuel rod with the lower grid; change of SG arrangements; strengthening of the lower grid unit; secure of the central tube in the gap. Water-uranium ration is increased. Introduction of all these kinds of modernization in a 5-year fuel cycle reduces fuel component in the energy cost to the 7%

  10. Effects of vitamin D supplementation on alveolar macrophage gene expression: preliminary results of a randomized, controlled trial.

    Science.gov (United States)

    Gerke, Alicia K; Pezzulo, Alejandro A; Tang, Fan; Cavanaugh, Joseph E; Bair, Thomas B; Phillips, Emily; Powers, Linda S; Monick, Martha M

    2014-03-26

    Vitamin D deficiency has been implicated as a factor in a number of infectious and inflammatory lung diseases. In the lung, alveolar macrophages play a key role in inflammation and defense of infection, but there are little data exploring the immunomodulatory effects of vitamin D on innate lung immunity in humans. The objective of this study was to determine the effects of vitamin D supplementation on gene expression of alveolar macrophages. We performed a parallel, double-blind, placebo-controlled, randomized trial to determine the effects of vitamin D on alveolar macrophage gene expression. Vitamin D3 (1000 international units/day) or placebo was administered to adults for three months. Bronchoscopy was performed pre- and post-intervention to obtain alveolar macrophages. Messenger RNA was isolated from the macrophages and subjected to whole genome exon array analysis. The primary outcome was differential gene expression of the alveolar macrophage in response to vitamin D supplementation. Specific genes underwent validation by polymerase chain reaction methods. Fifty-eight subjects were randomized to vitamin D (n = 28) or placebo (n = 30). There was a marginal overall difference between treatment group and placebo group in the change of 25-hydroxyvitaminD levels (4.43 ng/ml vs. 0.2 ng/ml, p = 0.10). Whole genome exon array analysis revealed differential gene expression associated with change in serum vitamin D levels in the treated group. CCL8/MCP-2 was the top-regulated cytokine gene and was further validated. Although only a non-significant increased trend was seen in serum vitamin D levels, subjects treated with vitamin D supplementation had immune-related differential gene expression in alveolar macrophages. ClinicalTrials.org: NCT01967628.

  11. Clinical, biochemical and histological results of a double-blind trial with 1,25-dihydroxyvitamin D3, estradiol and placebo in post-menopausal osteoporosis.

    Science.gov (United States)

    Caniggia, A; Delling, G; Nuti, R; Lorè, F; Vattimo, A

    1984-01-01

    Twenty-eight women with postmenopausal osteoporosis were studied in a double-blind trial aimed to compare the effects of a one-year treatment with 1,25-dihydroxyvitamin D3 (1,25(OH)2D3), estradiol valerate (E2) and placebo. Patients were divided into 4 groups: group 1 was given 1,25(OH)2D3 alone, group 2 was given E2 alone, group 3 was given 1,25(OH)2D3 + E2, group 4 received a placebo. The evaluation of the effects of the treatments included clinical examination of patients, the measurement of a number of biochemical parameters, such as plasma and urinary calcium and phosphate, urinary hydroxyproline, serum alkaline phosphatase, the measurement of intestinal calcium absorption and bone mineral content (BMC) and a histomorphometric study of bone biopsies from the iliac crest. The best clinical results were obtained in the patients who were given 1,25(OH)2D3 alone; appreciable results were also noticed in the patients who were given E2 alone or in combination with 1,25(OH)2D3, while patients in the placebo group worsened. BMC decreased in the placebo group and increased, although non significantly, in the patients treated with 1,25(OH)2D3 or E2 or both. The histomorphometric study showed a significant increase in the mean trabecular diameter in patients treated with 1,25(OH)2D3 alone or in combination with E2. Changes in the volume density of trabecular bone paralleled those in BMC. The results of the trial indicate that 1,25(OH)2D3 is an effective therapeutic agent in postmenopausal osteoporosis.

  12. Vitamin D and Testosterone in Healthy Men: A Randomized Controlled Trial

    NARCIS (Netherlands)

    Lerchbaum, Elisabeth; Pilz, Stefan; Trummer, Christian; Schwetz, Verena; Pachernegg, Oliver; Heijboer, Annemieke C.; Obermayer-Pietsch, Barbara

    2017-01-01

    Available evidence shows an association of vitamin D with androgen levels in men. However, results from preliminary randomized controlled trials (RCTs) are conflicting. To evaluate whether vitamin D supplementation increases total testosterone (TT) levels in healthy men. The Graz Vitamin D&TT-RCT is

  13. Treatment of Advanced Glaucoma Study: a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma-study protocol.

    Science.gov (United States)

    King, Anthony J; Fernie, Gordon; Azuara-Blanco, Augusto; Burr, Jennifer M; Garway-Heath, Ted; Sparrow, John M; Vale, Luke; Hudson, Jemma; MacLennan, Graeme; McDonald, Alison; Barton, Keith; Norrie, John

    2017-10-26

    Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients. To compare clinical and cost-effectiveness of primary medical management compared with primary surgery for people presenting with advanced open-angle glaucoma (OAG). Design : A prospective, pragmatic multicentre randomised controlled trial (RCT). Twenty-seven UK hospital eye services. Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss. Participants will be randomised to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes). The primary outcome is vision-related quality of life measured by the National Eye Institute-Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 and glaucoma-related health status (Glaucoma Utility Index), patient experience, visual field measured by mean deviation value, logarithm of the mean angle of resolution visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per quality-adjusted life-year (QALY) based on EQ-5D-5L and glaucoma profile instrument will be estimated. The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in patients presenting with advanced glaucoma in terms of patient-reported health and visual function, clinical outcomes and incremental cost per QALY at 2 years. Treatment of Advanced Glaucoma Study will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma. ISRCTN56878850, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial

  14. Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial

    Directory of Open Access Journals (Sweden)

    Rinaldo Massimo

    2011-02-01

    Full Text Available Abstract Background To evaluate whether weekly schedules of docetaxel-based chemotherapy were superior to 3-weekly ones in terms of quality of life in locally advanced or metastatic breast cancer. Methods Patients with locally advanced or metastatic breast cancer, aged ≤ 70 years, performance status 0-2, chemotherapy-naive for metastatic disease, were eligible. They were randomized to weekly or 3-weekly combination of docetaxel and epirubicin, if they were not treated with adjuvant anthracyclines, or docetaxel and capecitabine, if treated with adjuvant anthracyclines. Primary end-point was global quality of life change at 6-weeks, measured by EORTC QLQ-C30. With two-sided alpha 0.05 and 80% power for 35% effect size, 130 patients per arm were needed. Results From February 2004 to March 2008, 139 patients were randomized, 70 to weekly and 69 to 3-weekly arm; 129 and 89 patients filled baseline and 6-week questionnaires, respectively. Global quality of life was better in the 3-weekly arm (p = 0.03; patients treated with weekly schedules presented a significantly worsening in role functioning and financial scores (p = 0.02 and p Conclusions In this trial, the weekly schedules of docetaxel-based chemotherapy appear to be inferior to the 3-weekly one in terms of quality of life in patients with locally advanced or metastatic breast cancer. Trial registration ClinicalTrials.gov NCT00540800.

  15. Risk of discontinuation of Advanced Therapy Medicinal Products clinical trials.

    Science.gov (United States)

    Hanna, Eve; Rémuzat, Cecile; Auquier, Pascal; Toumi, Mondher

    2016-01-01

    Advanced therapy medicinal products (ATMPs) constitute a class of innovative products that encompasses gene therapy, somatic cell therapy, and tissue-engineered products (TEP). There is an increased investment of commercial and non-commercial sponsors in this field and a growing number of ATMPs randomized clinical trials (RCT) and patients enrolled in such trials. RCT generate data to prove the efficacy of a new therapy, but the discontinuation of RCTs wastes scarce resources. Our objective is to identify the number and characteristics of discontinued ATMPs trials in order to evaluate the rate of discontinuation. We searched for ATMPs trials conducted between 1999 to June 2015 using three databases, which are Clinicaltrials.gov, the International Clinical Trials Registry Platform (ICTRP), and the EU Drug Regulating Authorities Clinical Trials (EudraCT). We selected the ATMPs trials after elimination of the duplicates. We identified the disease areas and the sponsors as commercial or non-commercial organizations. We classified ATMPs by type and trial status, that is, ongoing, completed, terminated, discontinued, and prematurely ended. Then, we calculated the rate of discontinuation. Between 1999 and June 2015, 143 withdrawn, terminated, or prematurely ended ATMPs clinical trials were identified. Between 1999 and June 2013, 474 ongoing and completed clinical trials were identified. Therefore, the rate of discontinuation of ATMPs trials is 23.18%, similar to that for non-ATMPs drugs in development. The probability of discontinuation is, respectively, 27.35, 16.28, and 16.34% for cell therapies, gene therapies, and TEP. The highest discontinuation rate is for oncology (43%), followed by cardiology (19.2%). It is almost the same for commercial and non-commercial sponsors; therefore, the discontinuation reason may not be financially driven. No failure risk rate per development phase is available for ATMPs. The discontinuation rate may prove helpful when assessing the

  16. Advanced 3D Printers for Cellular Solids

    Science.gov (United States)

    2016-06-30

    06-2016 1-Aug-2014 31-Dec-2015 Final Report: Advanced 3D printers for Cellular Solids The views, opinions and/or findings contained in this report are...2211 3d printing, cellular solids REPORT DOCUMENTATION PAGE 11. SPONSOR/MONITOR’S REPORT NUMBER(S) 10. SPONSOR/MONITOR’S ACRONYM(S) ARO 8...Papers published in non peer-reviewed journals: Final Report: Advanced 3D printers for Cellular Solids Report Title Final Report for DURIP grant W911NF

  17. A Randomized Controlled Trial Comparing the Letter Project Advance Directive to Traditional Advance Directive.

    Science.gov (United States)

    Periyakoil, Vyjeyanthi S; Neri, Eric; Kraemer, Helena

    2017-09-01

    Simpler alternatives to traditional advance directives that are easy to understand and available in multiple formats and can be initiated by patients and families will help facilitate advance care planning. The goal of this study was to compare the acceptability of the letter advance directive (LAD) to the traditional advance directive (TAD) of the state of California. A web-based, randomized controlled trial was conducted, in which the participants were randomized to one of two types of advance directives (ADs): the LAD (intervention) or the TAD (control). Primary outcomes were participant ratings of the ease, value, and their level of comfort in the AD document they completed. A total of 400 participants completed the study, with 216 randomized to the LAD and 184 to the TAD by a computerized algorithm. Overall, participants preferred the LAD to the TAD (success rate difference [SRD] = 0.46, 95th percentile confidence interval [CI]: 0.36-0.56, p advance directive to be a better alternative to the traditional advance directive form.

  18. 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

  19. Features and Initial Results of the DIII-D Advanced Tokamak Radiative Divertor

    International Nuclear Information System (INIS)

    R.C. O'Neill; A.S. Bozek; M.E. Friend; C.B. Baxi; E.E. Reis; M.A. Mahdavi; D.G. Nilson; S.L. Allen; W.P. West

    1999-01-01

    The Radiative Divertor Program of DIII-D is in its final phase with the installation of the cryopump and baffle structure (Phase 1B Divertor) in the upper inner radius of the DIII-D vacuum vessel at the end of this calendar year. This divertor, in conjunction with the Advanced Divertor and the Phase 1A Divertor, located in the lower and upper outer radius of the DIII-D vacuum vessel respectively, provides pumping for density control of the plasma while minimizing the effects on the core confinement. Each divertor consists of a cryobelium cooling ring and a shielded protective structure. The cryo/helium-cooled pumps of all three diverters exhaust helium from the plasma. The protective shielded structure or baffle structure, in the case of the diverters located at the top of the vacuum vessel, provides baffling of neutral charged particles and minimize the flow of impurities back into the core of the plasma. The baffles, which consist of water-cooled panels that allow for the attachment of tiles of various sizes and shapes, house gas puff systems. The intent of the puffing systems is to inject gas in and around the divertor to minimize the heat flux on specific areas on the divertor and its components. The reduction of the heat flux on the divertor minimizes the impurities that are generated from excess heat on divertor components, specifically tiles. Experiments involving the gas puff systems and the divertor structures have shown the heat flux can be spread over a large area of the divertor, reducing the peak heat flux in specific areas. The three diverters also incorporate a variety of diagnostic tools such as halo current monitors, magnetic probes and thermocouples to monitor certain plasma characteristics as well as determine the effectiveness of the cryopumps and baffle configurations. The diverters were designed to optimize pumping performance and to withstand the electromagnetic loads from both halo currents and toroidal induced currents. Incorporated also

  20. Long-term results of a randomized trial in locally advanced rectal cancer: no benefit from adding a brachytherapy boost

    DEFF Research Database (Denmark)

    Appelt, Ane L; Vogelius, Ivan R; Pløen, John

    2014-01-01

    PURPOSE/OBJECTIVE(S): Mature data on tumor control and survival are presented from a randomized trial of the addition of a brachytherapy boost to long-course neoadjuvant chemoradiation therapy (CRT) for locally advanced rectal cancer. METHODS AND MATERIALS: Between March 2005 and November 2008, 248...... patients with T3-4N0-2M0 rectal cancer were prospectively randomized to either long-course preoperative CRT (50.4 Gy in 28 fractions, per oral tegafur-uracil and L-leucovorin) alone or the same CRT schedule plus a brachytherapy boost (10 Gy in 2 fractions). The primary trial endpoint was pathologic...... on stratification for tumor regression grade and resection margin status indicated the presence of response migration. CONCLUSIONS: Despite increased pathologic tumor regression at the time of surgery, we observed no benefit on late outcome. Improved tumor regression does not necessarily lead to a relevant clinical...

  1. Overview of recent experimental results from the DIII-D advanced tokamak program

    International Nuclear Information System (INIS)

    Burrell, K.H.

    2003-01-01

    The D III-D research program is developing the scientific basis for advanced tokamak (AT) modes of operation in order to enhance the attractiveness of the tokamak as an energy producing system. Since the last International Atomic Energy Agency (IAEA) meeting, we have made significant progress in developing the building blocks needed for AT operation: 1) We have doubled the magnetohydrodynamic (MHD) stable tokamak operating space through rotational stabilization of the resistive wall mode; 2) Using this rotational stabilization, we have achieved β N H 89 ≥ 10 for 4 τ E limited by the neoclassical tearing mode; 3) Using real-time feedback of the electron cyclotron current drive (ECCD) location, we have stabilized the (m,n) = (3,2) neoclassical tearing mode and then increased β T by 60%; 4) We have produced ECCD stabilization of the (2,1) neoclassical tearing mode in initial experiments; 5) We have made the first integrated AT demonstration discharges with current profile control using ECCD; 6) ECCD and electron cyclotron heating (ECH) have been used to control the pressure profile in high performance plasmas; and 7) We have demonstrated stationary tokamak operation for 6.5 s (36 τ E ) at the same fusion gain parameter of β N H 89 /q 95 2 ≅ 0.4 as ITER but at much higher q 95 = 4.2. We have developed general improvements applicable to conventional and advanced tokamak operating modes: 1) We have an existence proof of a mode of tokamak operation, quiescent H-mode, which has no pulsed, ELM heat load to the divertor and which can run for long periods of time (3.8 s or 25 τ E ) with constant density and constant radiated power; 2) We have demonstrated real-time disruption detection and mitigation for vertical disruption events using high pressure gas jet injection of noble gases; 3) We have found that the heat and particle fluxes to the inner strike points of balanced, double-null divertors are much smaller than to the outer strike points. (author)

  2. Long-Term Results of a Randomized Trial in Locally Advanced Rectal Cancer: No Benefit From Adding a Brachytherapy Boost

    International Nuclear Information System (INIS)

    Appelt, Ane L.; Vogelius, Ivan R.; Pløen, John; Rafaelsen, Søren R.; Lindebjerg, Jan; Havelund, Birgitte M.; Bentzen, Søren M.; Jakobsen, Anders

    2014-01-01

    Purpose/Objective(s): Mature data on tumor control and survival are presented from a randomized trial of the addition of a brachytherapy boost to long-course neoadjuvant chemoradiation therapy (CRT) for locally advanced rectal cancer. Methods and Materials: Between March 2005 and November 2008, 248 patients with T3-4N0-2M0 rectal cancer were prospectively randomized to either long-course preoperative CRT (50.4 Gy in 28 fractions, per oral tegafur-uracil and L-leucovorin) alone or the same CRT schedule plus a brachytherapy boost (10 Gy in 2 fractions). The primary trial endpoint was pathologic complete response (pCR) at the time of surgery; secondary endpoints included overall survival (OS), progression-free survival (PFS), and freedom from locoregional failure. Results: Results for the primary endpoint have previously been reported. This analysis presents survival data for the 224 patients in the Danish part of the trial. In all, 221 patients (111 control arm, 110 brachytherapy boost arm) had data available for analysis, with a median follow-up time of 5.4 years. Despite a significant increase in tumor response at the time of surgery, no differences in 5-year OS (70.6% vs 63.6%, hazard ratio [HR] = 1.24, P=.34) and PFS (63.9% vs 52.0%, HR=1.22, P=.32) were observed. Freedom from locoregional failure at 5 years were 93.9% and 85.7% (HR=2.60, P=.06) in the standard and in the brachytherapy arms, respectively. There was no difference in the prevalence of stoma. Explorative analysis based on stratification for tumor regression grade and resection margin status indicated the presence of response migration. Conclusions: Despite increased pathologic tumor regression at the time of surgery, we observed no benefit on late outcome. Improved tumor regression does not necessarily lead to a relevant clinical benefit when the neoadjuvant treatment is followed by high-quality surgery

  3. Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients (LapOvCa-trial): a multicentre randomized controlled study

    International Nuclear Information System (INIS)

    Rutten, Marianne J; Pijnenborg, Johanna MA; Schreuder, Henk WR; Schutter, Eltjo MJ; Spijkerboer, Anje M; Wensveen, Celesta WM; Zusterzeel, Petra; Mol, Ben Willem J; Kenter, Gemma G; Buist, Marrije R; Gaarenstroom, Katja N; Van Gorp, Toon; Meurs, Hannah S van; Arts, Henriette JG; Bossuyt, Patrick M; Ter Brugge, Henk G; Hermans, Ralph HM; Opmeer, Brent C

    2012-01-01

    Standard treatment of advanced ovarian cancer is surgery and chemotherapy. The goal of surgery is to remove all macroscopic tumour, as the amount of residual tumour is the most important prognostic factor for survival. When removal off all tumour is considered not feasible, neoadjuvant chemotherapy (NACT) in combination with interval debulking surgery (IDS) is performed. Current methods of staging are not always accurate in predicting surgical outcome, since approximately 40% of patients will have more than 1 cm residual tumour after primary debulking surgery (PDS). In this study we aim to assess whether adding laparoscopy to the diagnostic work-up of patients suspected of advanced ovarian carcinoma may prevent unsuccessful primary debulking surgery for ovarian cancer. Multicentre randomized controlled trial, including all gynaecologic oncologic centres in the Netherlands and their affiliated hospitals. Patients are eligible when they are planned for PDS after conventional staging. Participants are randomized between direct PDS or additional diagnostic laparoscopy. Depending on the result of laparoscopy patients are treated by PDS within three weeks, followed by six courses of platinum based chemotherapy or with NACT and IDS 3-4 weeks after three courses of chemotherapy, followed by another three courses of chemotherapy. Primary outcome measure is the proportion of PDS's leaving more than one centimetre tumour residual in each arm. In total 200 patients will be randomized. Data will be analysed according to intention to treat. Patients who have disease considered to be resectable to less than one centimetre should undergo PDS to improve prognosis. However, there is a need for better diagnostic procedures because the current number of debulking surgeries leaving more than one centimetre residual tumour is still high. Laparoscopy before starting treatment for ovarian cancer can be an additional diagnostic tool to predict the outcome of PDS. Despite the absence

  4. Advancing the educational and career pathway for clinical trials nurses.

    Science.gov (United States)

    Scott, Kathleen; White, Kathryn; Roydhouse, Jessica K

    2013-04-01

    Clinical trials nurses play a pivotal role in the conduct of clinical research, but the educational and career pathway for these nurses remains unclear. This article reports findings from a survey of nurses working in cancer clinical trials research in Australia. Most participants held postgraduate qualifications (42 of 61); however, clinical trials education was primarily attained through short professional development courses. Interest in pursuing trial-specific postgraduate education was high, but barriers were identified, including cost, time, and unclear benefit for career advancement. Job titles varied substantially, which is indicative of an unclear employment pathway. These findings suggest that initiatives to improve the educational and career pathway for clinical trials nurses are needed and should include the following: formal educational preparation, greater consistency in employment status, and clearer career progression. These strategies should be underpinned by broad professional recognition of the clinical trials nurse as a specialized nursing role. Copyright 2013, SLACK Incorporated.

  5. Estimation of the optimum dose of vitamin D for disease prevention in older people: rationale, design and baseline characteristics of the BEST-D trial.

    Science.gov (United States)

    Clarke, Robert; Newman, Connie; Tomson, Joseph; Hin, Harold; Kurien, Rijo; Cox, Jolyon; Lay, Michael; Sayer, Jenny; Hill, Michael; Emberson, Jonathan; Armitage, Jane

    2015-04-01

    Previous large trials of vitamin D for prevention of fractures and other disease outcomes have reported conflicting results, possibly because the doses tested were insufficient to maintain optimum blood levels of vitamin D (25[OH]D) predicted by the observational studies. This report describes the design and baseline characteristics of the BEST-D (Biochemical Efficacy and Safety Trial of vitamin D) trial which aims to establish the best dose of vitamin D to assess in a future large outcome trial. The BEST-D trial will compare the biochemical and other effects of daily dietary supplementation with 100 μg or 50 μg vitamin D3 or placebo, when administered for 12 months, in 305 ambulant community-dwelling older people living in Oxfordshire, England. The primary analyses will compare 12-month mean plasma concentrations of 25(OH)D as well as the proportion of participants with a 12-month concentration >90 nmol/L between participants allocated 100 μg and participants allocated 50 μg daily. Secondary analyses will compare the two active doses (both separately and when combined) with placebo. Additional end-points include biochemical assessments of safety, blood pressure, arterial stiffness, falls, fractures, heel and wrist bone density, grip strength and physical performance and echocardiographic assessments of cardiac function in a random sample of participants. About one-third of eligible participants agreed to participate in the trial. The mean age was 72 (SD 6) years with equal numbers of men and women. About one third reported a prior history of fracture or hypertension, one-fifth reported a prior cardiovascular event, and one tenth reported diabetes or a fall in the previous 6 months. The results of this trial will help determine the optimum dose of vitamin D to test in a larger trial investigating whether vitamin D supplementation can reduce the risk of fractures, cardiovascular disease or cancer. Crown Copyright © 2015. Published by Elsevier Ireland Ltd. All

  6. Vitamin D supplementation has no major effect on pain or pain behavior in bedridden geriatric patients with advanced dementia.

    Science.gov (United States)

    Björkman, Mikko; Sorva, Antti; Tilvis, Reijo

    2008-08-01

    In a few, earlier, uncontrolled trials, alleviation of chronic pain has been documented by vitamin D supplementation. This randomized double-blind placebo controlled trial addressed the association between pain and vitamin D deficiency and the effects of vitamin D supplementation on pain in institutionalized aged patients. 216 long-term care patients were enrolled in Helsinki, Finland. Pain was assessed by three tools: Resident Assessment Instrument (RAI), Discomfort Behavior Scale, and Pain Assessment in Advanced Dementia Scale. Scores for Cognitive Performance Scale (CPS) and other clinical assessments were also collected from the RAI-database. Levels of 25-hydroxyvitamin D (25- OHD) and parathyroid hormone were also determined. Patients in pain (n=202) were randomized into three treatment groups, each receiving 0, 400, or 1200 IU cholecalciferol per day, respectively. Assessments were repeated after six-month vitamin D supplementation. Patients were aged (84.5+/-7.5 yrs), demented (CPS= 4.9+/-1.4, range 1-6), and chronically bedridden. Pain was present in 38.4% to 83.8% of patients depending on assessment tool. Low 25-OHD levels (<50 nmol/L) were very common (98.1%). However, vitamin D deficiency was not associated with pain or pain behavior. The supplementation resulted in a marked increase in 25-OHD levels. However, neither prevalence of painlessness nor pain scores changed significantly after vitamin D supplementation. We were not able either to show an association between vitamin D deficiency and pain or to observe alleviation of pain by vitamin D supplementation. The independent role of vitamin D in the etiology of pain remains controversial.

  7. Advanced tokamak physics in DIII-D

    Energy Technology Data Exchange (ETDEWEB)

    Petty, C.C.; Luce, T.C.; Politzer, P.A.; Bray, B.; Burrell, K.H.; Chu, M.S.; Ferron, J.R.; Gohil, P.; Greenfield, C.M.; Hsieh, C.-L.; Hyatt, A.W.; La Haye, R.J.; Lao, L.L.; Leonard, A.W.; Lin-Liu, Y.R.; Lohr, J.; Mahdavi, M.A.; Petrie, T.W.; Pinsker, R.I.; Prater, R.; Scoville, J.T.; Staebler, G.M.; Strait, E.J.; Taylor, T.S.; West, W.P. [General Atomics, PO Box 85608, San Diego, CA (United States); Wade, M.R.; Lazarus, E.A.; Murakami, M. [Oak Ridge National Laboratory, Oak Ridge, TN (United States); Allen, S.L.; Casper, T.A.; Jayakumar, R.; Lasnier, C.J.; Makowski, M.A.; Rice, B.W.; Wolf, N.S. [Lawrence Livermore National Laboratory, Livermore, CA (United States); Austin, M.E. [University of Texas, Austin, TX (United States); Fredrickson, E.D.; Gorelov, I.; Johnson, L.C.; Okabayashi, M.; Wong, K.-L. [Princeton Plasma Physics Laboratory, Princeton, NJ (United States); Garofalo, A.M.; Navratil, G.A. [Columbia University, New York (United States); Heidbrink, W. [University of California, Irvine, CA (United States); Kinsey, J.E. [Leheigh University, Bethlehem, PA (United States); McKee, G.R. [University of Wisconsin, Madison, WI (United States); Rettig, C.L.; Rhodes, T.L. [University of California, Los Angeles, CA (United States); Watkins, J.G. [Sandia National Laboratories, Albuquerque, NM (United States)

    2000-12-01

    Advanced tokamaks seek to achieve a high bootstrap current fraction without sacrificing fusion power density or fusion gain. Good progress has been made towards the DIII-D research goal of demonstrating a high-{beta} advanced tokamak plasma in steady state with a relaxed, fully non-inductive current profile and a bootstrap current fraction greater than 50%. The limiting factors for transport, stability, and current profile control in advanced operating modes are discussed in this paper. (author)

  8. Results of antiretroviral treatment interruption and intensification in advanced multi-drug resistant HIV infection from the OPTIMA trial.

    Directory of Open Access Journals (Sweden)

    Mark Holodniy

    2011-03-01

    Full Text Available Guidance is needed on best medical management for advanced HIV disease with multidrug resistance (MDR and limited retreatment options. We assessed two novel antiretroviral (ARV treatment approaches in this setting.We conducted a 2×2 factorial randomized open label controlled trial in patients with a CD4 count≤300 cells/µl who had ARV treatment (ART failure requiring retreatment, to two options (a re-treatment with either standard (≤4 ARVs or intensive (≥5 ARVs ART and b either treatment starting immediately or after a 12-week monitored ART interruption. Primary outcome was time to developing a first AIDS-defining event (ADE or death from any cause. Analysis was by intention to treat. From 2001 to 2006, 368 patients were randomized. At baseline, mean age was 48 years, 2% were women, median CD4 count was 106/µl, mean viral load was 4.74 log(10 copies/ml, and 59% had a prior AIDS diagnosis. Median follow-up was 4.0 years in 1249 person-years of observation. There were no statistically significant differences in the primary composite outcome of ADE or death between re-treatment options of standard versus intensive ART (hazard ratio 1.17; CI 0.86-1.59, or between immediate retreatment initiation versus interruption before re-treatment (hazard ratio 0.93; CI 0.68-1.30, or in the rate of non-HIV associated serious adverse events between re-treatment options.We did not observe clinical benefit or harm assessed by the primary outcome in this largest and longest trial exploring both ART interruption and intensification in advanced MDR HIV infection with poor retreatment options.Clinicaltrials.gov NCT00050089.

  9. SU-D-17A-04: The Impact of Audiovisual Biofeedback On Image Quality During 4D Functional and Anatomic Imaging: Results of a Prospective Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Keall, P; Pollock, S [University of Sydney, Sydney (Australia); Yang, J; Diehn, M; Berger, J; Graves, E; Loo, B [Stanford University, Stanford, CA (United States); Yamamoto, T [UC Davis School of Medicine, Sacramento, CA (United States)

    2014-06-01

    Purpose: The ability of audiovisual (AV) biofeedback to improve breathing regularity has not previously been investigated for functional imaging studies. The purpose of this study was to investigate the impact of AV biofeedback on 4D-PET and 4D-CT image quality in a prospective clinical trial. We hypothesized that motion blurring in 4D-PET images and the number of artifacts in 4D-CT images are reduced using AV biofeedback. Methods: AV biofeedback is a real-time, interactive and personalized system designed to help a patient self-regulate his/her breathing using a patient-specific representative waveform and musical guides. In an IRB-approved prospective clinical trial, 4D-PET and 4D-CT images of 10 lung cancer patients were acquired with AV biofeedback (AV) and free breathing (FB). The 4D-PET images in 6 respiratory bins were analyzed for motion blurring by: (1) decrease of GTVPET and (2) increase of SUVmax in 4-DPET compared to 3D-PET. The 4D-CT images were analyzed for artifacts by: (1) comparing normalized cross correlation-based scores (NCCS); and (2) quantifying a visual assessment score (VAS). A two-tailed paired t-test was used to test the hypotheses. Results: The impact of AV biofeedback on 4D-PET and 4D-CT images varied widely between patients, suggesting inconsistent patient comprehension and capability. Overall, the 4D-PET decrease of GTVPET was 2.0±3.0cm3 with AV and 2.3±3.9cm{sup 3} for FB (p=0.61). The 4D-PET increase of SUVmax was 1.6±1.0 with AV and 1.1±0.8 with FB (p=0.002). The 4D-CT NCCS were 0.65±0.27 with AV and 0.60±0.32 for FB (p=0.32). The 4D-CT VAS was 0.0±2.7 (p=ns). Conclusion: A 10-patient study demonstrated a statistically significant reduction of motion blurring of AV over FB for 1/2 functional 4D-PET imaging metrics. No difference between AV and FB was found for 2 anatomic 4D-CT imaging metrics. Future studies will focus on optimizing the human-computer interface and including patient training sessions for improved

  10. SU-D-17A-04: The Impact of Audiovisual Biofeedback On Image Quality During 4D Functional and Anatomic Imaging: Results of a Prospective Clinical Trial

    International Nuclear Information System (INIS)

    Keall, P; Pollock, S; Yang, J; Diehn, M; Berger, J; Graves, E; Loo, B; Yamamoto, T

    2014-01-01

    Purpose: The ability of audiovisual (AV) biofeedback to improve breathing regularity has not previously been investigated for functional imaging studies. The purpose of this study was to investigate the impact of AV biofeedback on 4D-PET and 4D-CT image quality in a prospective clinical trial. We hypothesized that motion blurring in 4D-PET images and the number of artifacts in 4D-CT images are reduced using AV biofeedback. Methods: AV biofeedback is a real-time, interactive and personalized system designed to help a patient self-regulate his/her breathing using a patient-specific representative waveform and musical guides. In an IRB-approved prospective clinical trial, 4D-PET and 4D-CT images of 10 lung cancer patients were acquired with AV biofeedback (AV) and free breathing (FB). The 4D-PET images in 6 respiratory bins were analyzed for motion blurring by: (1) decrease of GTVPET and (2) increase of SUVmax in 4-DPET compared to 3D-PET. The 4D-CT images were analyzed for artifacts by: (1) comparing normalized cross correlation-based scores (NCCS); and (2) quantifying a visual assessment score (VAS). A two-tailed paired t-test was used to test the hypotheses. Results: The impact of AV biofeedback on 4D-PET and 4D-CT images varied widely between patients, suggesting inconsistent patient comprehension and capability. Overall, the 4D-PET decrease of GTVPET was 2.0±3.0cm3 with AV and 2.3±3.9cm 3 for FB (p=0.61). The 4D-PET increase of SUVmax was 1.6±1.0 with AV and 1.1±0.8 with FB (p=0.002). The 4D-CT NCCS were 0.65±0.27 with AV and 0.60±0.32 for FB (p=0.32). The 4D-CT VAS was 0.0±2.7 (p=ns). Conclusion: A 10-patient study demonstrated a statistically significant reduction of motion blurring of AV over FB for 1/2 functional 4D-PET imaging metrics. No difference between AV and FB was found for 2 anatomic 4D-CT imaging metrics. Future studies will focus on optimizing the human-computer interface and including patient training sessions for improved comprehension and

  11. Recent advances in 3D printing of biomaterials.

    Science.gov (United States)

    Chia, Helena N; Wu, Benjamin M

    2015-01-01

    3D Printing promises to produce complex biomedical devices according to computer design using patient-specific anatomical data. Since its initial use as pre-surgical visualization models and tooling molds, 3D Printing has slowly evolved to create one-of-a-kind devices, implants, scaffolds for tissue engineering, diagnostic platforms, and drug delivery systems. Fueled by the recent explosion in public interest and access to affordable printers, there is renewed interest to combine stem cells with custom 3D scaffolds for personalized regenerative medicine. Before 3D Printing can be used routinely for the regeneration of complex tissues (e.g. bone, cartilage, muscles, vessels, nerves in the craniomaxillofacial complex), and complex organs with intricate 3D microarchitecture (e.g. liver, lymphoid organs), several technological limitations must be addressed. In this review, the major materials and technology advances within the last five years for each of the common 3D Printing technologies (Three Dimensional Printing, Fused Deposition Modeling, Selective Laser Sintering, Stereolithography, and 3D Plotting/Direct-Write/Bioprinting) are described. Examples are highlighted to illustrate progress of each technology in tissue engineering, and key limitations are identified to motivate future research and advance this fascinating field of advanced manufacturing.

  12. SPIRIT trial: A phase III pragmatic trial of an advance care planning intervention in ESRD.

    Science.gov (United States)

    Song, Mi-Kyung; Unruh, Mark L; Manatunga, Amita; Plantinga, Laura C; Lea, Janice; Jhamb, Manisha; Kshirsagar, Abhijit V; Ward, Sandra E

    2018-01-01

    Advance care planning (ACP) is a central tenet of dialysis care, but the vast majority of dialysis patients report never engaging in ACP discussions with their care providers. Over the last decade, we have developed and iteratively tested SPIRIT (Sharing Patient's Illness Representation to Increase Trust), a theory-based, patient- and family-centered advance care planning intervention. SPIRIT is a six-step, two-session, face-to-face intervention to promote cognitive and emotional preparation for end-of-life decision making for patients with ESRD and their surrogates. In these explanatory trials, SPIRIT was delivered by trained research nurses. Findings consistently revealed that patients and surrogates in SPIRIT showed significant improvement in preparedness for end-of-life decision making, and surrogates in SPIRIT reported significantly improved post-bereavement psychological outcomes after the patient's death compared to a no treatment comparison condition. As a critical next step, we are conducting an effectiveness-implementation study. This study is a multicenter, clinic-level cluster randomized pragmatic trial to evaluate the effectiveness of SPIRIT delivered by dialysis care providers as part of routine care in free-standing outpatient dialysis clinics, compared to usual care plus delayed SPIRIT implementation. Simultaneously, we will evaluate the implementation of SPIRIT, including sustainability. We will recruit 400 dyads of patients at high risk of death in the next year and their surrogates from 30 dialysis clinics in four states. This trial of SPIRIT will generate novel, meaningful insights about improving ACP in dialysis care. ClinicalTrials.govNCT03138564, registered 05/01/2017. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Body Language Advanced 3D Character Rigging

    CERN Document Server

    Allen, Eric; Fong, Jared; Sidwell, Adam G

    2011-01-01

    Whether you're a professional Character TD or just like to create 3D characters, this detailed guide reveals the techniques you need to create sophisticated 3D character rigs that range from basic to breathtaking. Packed with step-by-step instructions and full-color illustrations, Body Language walks you through rigging techniques for all the body parts to help you create realistic and believable movements in every character you design. You'll learn advanced rigging concepts that involve MEL scripting and advanced deformation techniques and even how to set up a character pipeline.

  14. View Synthesis for Advanced 3D Video Systems

    Directory of Open Access Journals (Sweden)

    2009-02-01

    Full Text Available Interest in 3D video applications and systems is growing rapidly and technology is maturating. It is expected that multiview autostereoscopic displays will play an important role in home user environments, since they support multiuser 3D sensation and motion parallax impression. The tremendous data rate cannot be handled efficiently by representation and coding formats such as MVC or MPEG-C Part 3. Multiview video plus depth (MVD is a new format that efficiently supports such advanced 3DV systems, but this requires high-quality intermediate view synthesis. For this, a new approach is presented that separates unreliable image regions along depth discontinuities from reliable image regions, which are treated separately and fused to the final interpolated view. In contrast to previous layered approaches, our algorithm uses two boundary layers and one reliable layer, performs image-based 3D warping only, and was generically implemented, that is, does not necessarily rely on 3D graphics support. Furthermore, different hole-filling and filtering methods are added to provide high-quality intermediate views. As a result, high-quality intermediate views for an existing 9-view auto-stereoscopic display as well as other stereo- and multiscopic displays are presented, which prove the suitability of our approach for advanced 3DV systems.

  15. View Synthesis for Advanced 3D Video Systems

    Directory of Open Access Journals (Sweden)

    Müller Karsten

    2008-01-01

    Full Text Available Abstract Interest in 3D video applications and systems is growing rapidly and technology is maturating. It is expected that multiview autostereoscopic displays will play an important role in home user environments, since they support multiuser 3D sensation and motion parallax impression. The tremendous data rate cannot be handled efficiently by representation and coding formats such as MVC or MPEG-C Part 3. Multiview video plus depth (MVD is a new format that efficiently supports such advanced 3DV systems, but this requires high-quality intermediate view synthesis. For this, a new approach is presented that separates unreliable image regions along depth discontinuities from reliable image regions, which are treated separately and fused to the final interpolated view. In contrast to previous layered approaches, our algorithm uses two boundary layers and one reliable layer, performs image-based 3D warping only, and was generically implemented, that is, does not necessarily rely on 3D graphics support. Furthermore, different hole-filling and filtering methods are added to provide high-quality intermediate views. As a result, high-quality intermediate views for an existing 9-view auto-stereoscopic display as well as other stereo- and multiscopic displays are presented, which prove the suitability of our approach for advanced 3DV systems.

  16. F-18-FDG-PET Confined Radiotherapy of Locally Advanced NSCLC With Concomitant Chemotherapy: Results of the PET-PLAN Pilot Trial

    Energy Technology Data Exchange (ETDEWEB)

    Fleckenstein, Jochen [Department of Radiotherapy and Radiation Oncology, Saarland University Medical School, Homburg (Germany); Hellwig, Dirk [Department of Nuclear Medicine, Saarland University Medical School, Homburg (Germany); Kremp, Stephanie [Department of Radiotherapy and Radiation Oncology, Saarland University Medical School, Homburg (Germany); Grgic, Aleksandar [Department of Nuclear Medicine, Saarland University Medical School, Homburg (Germany); Groeschel, Andreas [Department of Internal Medicine V, Saarland University Medical School, Homburg (Germany); Kirsch, Carl-Martin [Department of Nuclear Medicine, Saarland University Medical School, Homburg (Germany); Nestle, Ursula [Department of Nuclear Medicine, Saarland University Medical School, Homburg (Germany); Clinic for Radiotherapy, University Hospital, Freiburg (Germany); Ruebe, Christian, E-mail: christian.ruebe@uks.eu [Department of Radiotherapy and Radiation Oncology, Saarland University Medical School, Homburg (Germany)

    2011-11-15

    Purpose: The integration of fluoro-deoxy-D-glucose positron emission tomography (FDG-PET) in the process of radiotherapy (RT) planning of locally advanced non-small-cell lung cancer (NSCLC) may improve diagnostic accuracy and minimize interobserver variability compared with target volume definition solely based on computed tomography. Furthermore, irradiating only FDG-PET-positive findings and omitting elective nodal regions may allow dose escalation by treating smaller volumes. The aim of this prospective pilot trial was to evaluate the therapeutic safety of FDG-PET-based RT treatment planning with an autocontour-derived delineation of the primary tumor. Methods and Materials: Eligible patients had Stages II-III inoperable NSCLC, and simultaneous, platinum-based radiochemotherapy was indicated. FDG-PET and computed tomography acquisitions in RT treatment planning position were coregistered. The clinical target volume (CTV) included the FDG-PET-defined primary tumor, which was autodelineated with a source-to-background algorithm, plus FDG-PET-positive lymph node stations. Limited by dose restrictions for normal tissues, prescribed total doses were in the range of 66.6 to 73.8 Gy. The primary endpoint was the rate of out-of-field isolated nodal recurrences (INR). Results: As per intent to treat, 32 patients received radiochemotherapy. In 15 of these patients, dose escalation above 66.6 Gy was achieved. No Grade 4 toxicities occurred. After a median follow-up time of 27.2 months, the estimated median survival time was 19.3 months. During the observation period, one INR was observed in 23 evaluable patients. Conclusions: FDG-PET-confined target volume definition in radiochemotherapy of NSCLC, based on a contrast-oriented source-to-background algorithm, was associated with a low risk of INR. It might provide improved tumor control because of dose escalation.

  17. Paired Phase II Studies of Erlotinib/Bevacizumab for Advanced Bronchioloalveolar Carcinoma or Never Smokers With Advanced Non-Small-cell Lung Cancer: SWOG S0635 and S0636 Trials.

    Science.gov (United States)

    West, Howard L; Moon, James; Wozniak, Antoinette J; Mack, Philip; Hirsch, Fred R; Bury, Martin J; Kwong, Myron; Nguyen, Dorothy D; Moore, Dennis F; Miao, Jieling; Redman, Mary; Kelly, Karen; Gandara, David R

    2018-01-01

    Before mutation testing of the epidermal growth factor receptor (EGFR) gene was recognized as highly associated with the activity of EGFR tyrosine kinase inhibitors (TKIs), clinically defined patient populations with bronchioloalveolar carcinoma (BAC) and never smokers were identified as likely to benefit from EGFR TKIs. From preclinical and clinical data suggesting potentially improved efficacy with a combination of an EGFR TKI and the antiangiogenic agent bevacizumab, the Southwestern Oncology Group (SWOG) initiated paired phase II trials to evaluate the combination of erlotinib/bevacizumab in patients with advanced BAC (SWOG S0635) or never smokers with advanced lung adenocarcinoma (SWOG S0636). Eligible patients with BAC or adenocarcinoma with BAC features (SWOG S0635) or never smokers with advanced lung adenocarcinoma (SWOG S0636) received erlotinib 150 mg/day with bevacizumab 15 mg/kg until progression or prohibitive toxicity. Never smokers with BAC were preferentially enrolled to SWOG S0636. The primary endpoint for both trials was overall survival. A total of 84 patients were enrolled in the SWOG S0635 trial and 85 in the SWOG S0636 trial. The objective response rate was 22% (3% complete response) in the SWOG S0635 trial and 50% (38% confirmed; 3% complete response) in the SWOG S0636 trial. The median progression-free survival was 5 and 7.4 months in the S0635 and S0636 trials, respectively. The median overall survival was 21 and 29.8 months, respectively. Toxicity consisted mainly of rash and diarrhea in both trials. Although the field has moved toward molecular, rather than clinical, selection of patients as optimal candidates for EGFR TKI therapy, these results support the hypothesis that a subset of patients in whom erlotinib is particularly active could receive an incremental benefit from the addition of bevacizumab. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Everolimus Plus Endocrine Therapy for Postmenopausal Women With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: A Clinical Trial.

    Science.gov (United States)

    Royce, Melanie; Bachelot, Thomas; Villanueva, Cristian; Özgüroglu, Mustafa; Azevedo, Sergio J; Cruz, Felipe Melo; Debled, Marc; Hegg, Roberto; Toyama, Tatsuya; Falkson, Carla; Jeong, Joon; Srimuninnimit, Vichien; Gradishar, William J; Arce, Christina; Ridolfi, Antonia; Lin, Chinjune; Cardoso, Fatima

    2018-03-22

    Cotargeting the mammalian target of rapamycin pathway and estrogen receptor may prevent or delay endocrine resistance in patients receiving first-line treatment for advanced breast cancer. To investigate the combination of everolimus plus endocrine therapy in first-line and second-line treatment settings for postmenopausal women with estrogen receptor-positive, human epidermal growth receptor 2-negative advanced breast cancer. In the multicenter, open-label, single-arm, phase 2 BOLERO-4 (Breast Cancer Trials of Oral Everolimus) clinical trial, 245 patients were screened for eligibility; 202 were enrolled between March 7, 2013, and December 17, 2014. A median follow-up of 29.5 months had been achieved by the data cutoff date (December 17, 2016). Patients received first-line treatment with everolimus, 10 mg/d, plus letrozole, 2.5 mg/d. Second-line treatment with everolimus, 10 mg/d, plus exemestane, 25 mg/d, was offered at the investigator's discretion upon initial disease progression. The primary end point was investigator-assessed progression-free survival in the first-line setting per Response Evaluation Criteria in Solid Tumors, version 1.0. Safety was assessed in patients who received at least 1 dose of study medication and at least 1 postbaseline safety assessment. A total of 202 women treated in the first-line setting had a median age of 64.0 years (interquartile range, 58.0-70.0 years) with metastatic (194 [96.0%]) or locally advanced (8 [4.0%]) breast cancer. Median progression-free survival was 22.0 months (95% CI, 18.1-25.1 months) with everolimus and letrozole. Median overall survival was not reached; 24-month estimated overall survival rate was 78.7% (95% CI, 72.1%-83.9%). Fifty patients started second-line treatment; median progression-free survival was 3.7 months (95% CI, 1.9-7.4 months). No new safety signals were observed. In the first-line setting, the most common all-grade adverse event was stomatitis (139 [68.8%]); the most common grade 3 to 4

  19. Innovation and the future of advanced dosimetry: 2D to 5D

    Science.gov (United States)

    Oldham, Mark

    2017-05-01

    Recent years have witnessed a remarkable evolution in the techniques, capabilities and applications of 3D dosimetry. Initially the goal was simple: to innovate new techniques capable of comprehensively measuring and verifying exquisitely intricate dose distributions from a paradigm changing emerging new therapy, IMRT. Basic questions emerged: how well were treatment planning systems modelling the complex delivery, and how could treatments be verified for safe use on patients? Since that time, equally significant leaps of innovation have continued in the technology of treatment delivery. In addition, clinical practice has been transformed by the addition of on-board imaging capabilities, which tend to hypo-fractionation strategies and margin reduction. The net result is a high stakes treatment setting where the clinical morbidity of any unintended treatment deviation is exacerbated by the combination of highly conformal dose distributions given with reduced margins with fractionation regimens unfriendly to healthy tissue. Not surprisingly this scenario is replete with challenges and opportunities for new and improved dosimetry systems. In particular tremendous interest exists in comprehensive 3D dosimetry systems, and systems that can resolve the dose in moving structures (4D) and even in deforming structures (5D). Despite significant progress in the capability of multi-dimensional dosimetry systems, it is striking that true 3D dosimetry systems are today largely found in academic institutions or specialist clinics. The reasons will be explored. We will highlight innovations occurring both in treatment delivery and in advanced dosimetry methods designed to verify them, and explore current and future opportunities for advanced dosimetry tools in clinical practice and translational research.

  20. Androgen suppression plus radiation vs. radiation alone for patients with D1 (pN+) adenocarcinoma of the prostate (results based on a national prospective randomized trial RTOG 85-31)

    International Nuclear Information System (INIS)

    Lawton, Colleen A.; Pajak, Thomas F.; Byhardt, Roger; Sause, William T.; Hanks, Gerald E.; Russell, Anthony H.; Rotman, Marvin; Porter, Arthur; McGowan, David G.; DelRowe, John D.; Pilepich, Miljenko V.

    1996-01-01

    Purpose/Objective: To evaluate the effect of immediate androgen suppression in conjunction with standard external beam irradiation versus radiation alone on a group of pathologically staged lymph node positive patients with adenocarcinoma of the prostate. Methods and Materials: A national prospective randomized trial of standard external beam irradiation plus immediate androgen suppression vs. external beam irradiation alone was initiated in 1985 for patients with locally advanced adenocarcinoma of the prostate. One hundred seventy two of the patients in this trial had biopsy proven pathologically involved lymph nodes. Ninety Eight of these patients received radiation plus the immediate androgen suppression (LHRH agonist) while 74 received radiation alone with hormonal manipulation instituted at the time of relapse. Results: With a median followup of 3.9 years actuarial progression free survival at five years was 56% for the patients who received radiation plus immediate LHRH agonist versus 33% patients who received radiation alone with hormonal manipulation at relapse (p = .0009). Since all of these patients had locally advanced disease (i.e. pathologically positive lymph nodes) stage does not explain this difference in outcome and gleason grade was not statistically different between the two groups. Although not statistically different at this point both overall survival and cause specific survival favor radiation and immediate LHRH agonist. Actuarial overall survival at five years for the radiation and LHRH group was 69% versus 59% for the radiation alone group who received androgen suppression at relapse. Actuarial cause specific survival at five years was 84% for the radiation and immediate LHRH agonist group and 73% for the radiation alone group. Conclusion: Patients with adenocarcinoma of the prostate and pathologically involved pelvic lymph nodes (pN+ or clinical stage D 1 ) should be seriously considered for external beam irradiation plus immediate

  1. Linking ClinicalTrials.gov and PubMed to track results of interventional human clinical trials.

    Directory of Open Access Journals (Sweden)

    Vojtech Huser

    Full Text Available OBJECTIVE: In an effort to understand how results of human clinical trials are made public, we analyze a large set of clinical trials registered at ClinicalTrials.gov, the world's largest clinical trial registry. MATERIALS AND METHODS: We considered two trial result artifacts: (1 existence of a trial result journal article that is formally linked to a registered trial or (2 the deposition of a trial's basic summary results within the registry. RESULTS: The study sample consisted of 8907 completed, interventional, phase 2-or-higher clinical trials that were completed in 2006-2009. The majority of trials (72.2% had no structured trial-article link present. A total of 2367 trials (26.6% deposited basic summary results within the registry. Of those, 969 trials (10.9% were classified as trials with extended results and 1398 trials (15.7% were classified as trials with only required basic results. The majority of the trials (54.8% had no evidence of results, based on either linked result articles or basic summary results (silent trials, while a minimal number (9.2% report results through both registry deposition and publication. DISCUSSION: Our study analyzes the body of linked knowledge around clinical trials (which we refer to as the "trialome". Our results show that most trials do not report results and, for those that do, there is minimal overlap in the types of reporting. We identify several mechanisms by which the linkages between trials and their published results can be increased. CONCLUSION: Our study shows that even when combining publications and registry results, and despite availability of several information channels, trial sponsors do not sufficiently meet the mandate to inform the public either via a linked result publication or basic results submission.

  2. Adjuvant radiochemotherapy in locally advanced gastric cancer. Treatment results and analysis of possible prognostic factors

    International Nuclear Information System (INIS)

    Martin Sanchez, Mercedes; Perez Escutia, Maria Angeles; Guardado Gonzales, Sandra; Cabezas Mendoza, Ana Maria; Campos Bonel, Arantxa; Perez Montero, Hector; Ambrosi, Rafael d'; Perez-Regadera Gomez, Jose Fermin; Lora Pablos, David

    2017-01-01

    The aim of this study was to report the clinical outcome and toxicity of radiochemotherapy in locally advanced gastric cancer (LAGC) patients treated according to the Intergroup 116 trial protocol in our institution. We retrospectively reviewed 105 patients with LAGC treated with radical surgery and adjuvant radiochemotherapy. We analyzed overall survival (OS), disease-free survival (DFS), locoregional failure-free survival (LFS), prognostic factors and toxicity. The mean follow-up was 96.48 months. The majority of tumors were T3-T4 (75%) and 86.6% had nodal metastases. The OS, DFS and LFS rates to 3 years were 53.48%, 52.75% and 81.65%, respectively and to 5 years 40%, 46.73% and 76.77% respectively. The univariate analysis showed that N stage < N2, TN stage < IIIA, R0 resection and N-ratio < 3 were statistically significant prognostic factors for OS and DFS, T stage < T4 for OS and N-ratio < 3 for LFS. The group with D2 lymphadenectomy had worse LFS than the D1 group (65.2% vs 88.1%, respectively, p = 0.039) probably due to a significant difference in the proportion node positive patients in the D2 group (94% vs. 78%; p = 0.027). In the multivariate analysis, only R0 resection was statistically significant factor for improved OS (p = 0.018). Acute grade III-IV gastrointestinal and hematologic toxicity rates were 8.5% and 15.2%, respectively and 89.5% completed treatment as planned. Our results are consistent with those of the Intergroup-0116 trial for LAGC in terms of survival. This regimen is well tolerated and with acceptable toxicity. An R0 resection was an independent prognostic factor for improved OS. (orig.) [de

  3. Vitamin D supplementation during pregnancy: state of the evidence from a systematic review of randomised trials.

    Science.gov (United States)

    Roth, Daniel E; Leung, Michael; Mesfin, Elnathan; Qamar, Huma; Watterworth, Jessica; Papp, Eszter

    2017-11-29

    Objectives  To estimate the effects of vitamin D supplementation during pregnancy on 11 maternal and 27 neonatal/infant outcomes; to determine frequencies at which trial outcome data were missing, unreported, or inconsistently reported; and to project the potential contributions of registered ongoing or planned trials. Design  Systematic review and meta-analysis of randomised controlled trials; systematic review of registered but unpublished trials. Data sources  Medline, Embase, PubMed, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials from inception to September 2017; manual searches of reference lists of systematic reviews identified in the electronic search; and online trial registries for unpublished, ongoing, or planned trials. Eligibility criteria for study selection  Trials of prenatal vitamin D supplementation with randomised allocation and control groups administered placebo, no vitamin D, or vitamin D ≤600 IU/day (or its equivalent), and published in a peer reviewed journal. Results  43 trials (8406 participants) were eligible for meta-analyses. Median sample size was 133 participants. Vitamin D increased maternal/cord serum concentration of 25-hydroxyvitamin D, but the dose-response effect was weak. Maternal clinical outcomes were rarely ascertained or reported, but available data did not provide evidence of benefits. Overall, vitamin D increased mean birth weight of 58.33 g (95% confidence interval 18.88 g to 97.78 g; 37 comparisons) and reduced the risk of small for gestational age births (risk ratio 0.60, 95% confidence interval 0.40 to 0.90; seven comparisons), but findings were not robust in sensitivity and subgroup analyses. There was no effect on preterm birth (1.0, 0.77 to 1.30; 15 comparisons). There was strong evidence that prenatal vitamin D reduced the risk of offspring wheeze by age 3 years (0.81, 0.67 to 0.98; two comparisons). For most outcomes, meta-analyses included data from a minority

  4. Fast Neutron Radiotherapy for Locally Advanced Prostate Cancer: Final Report of a Radiation Therapy Oncology Group Randomized Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Laramore, G. E.; Krall, J. M.; Thomas, F. J.; Russell, K. J.; Maor, M. H.; Hendrickson, F. R.; Martz, K. L.; Griffin, T. W.; Davis, L. W.

    1993-01-01

    Between June 1977 and April 1983 the Radiation Therapy Oncology Group (RTOG) sponsored a Phase III randomized trial investigating the use of fast neutron radiotherapy for patients with locally advanced (Stages C and D1) adenocarcinoma of the prostate gland. Patients were randomized to receive either conventional photon radiation or fast neutron radiation used in a mixed-beam (neutron/photon) treatment schedule. A total of 91 analyzable patients were entered into the study, and the two patient groups were balanced with respect to the major prognostic variables. Actuarial curves are presented for local/regional control and "overall" survival. Ten-year results for clinically assessed local control are 70% for the mixed-beam group versus 58% for the photon group (p = 0.03) and for survival are 46% for the mixed-beam group versus 29% for the photon group (p = 0.04). This study suggests that a regional method of treatment can influence both local tumor control and survival in patients with locally advanced adenocarcinoma of the prostate gland.

  5. RTOG: Updated results of randomized trials

    International Nuclear Information System (INIS)

    Curran, Walter J.

    1997-01-01

    Objective: To review the background, rationale and available results for recently completed randomized comparative clinical trials of the Radiation Therapy Oncology Group (RTOG), including inter group trials in which the RTOG has been the managing group or a major participant. When available, laboratory studies will be correlated with clinical results

  6. Post Landsat-D advanced concept evaluation /PLACE/

    Science.gov (United States)

    Alexander, L. D.; Alvarado, U. R.; Flatow, F. S.

    1979-01-01

    The aim of the Post Landsat-D Advanced Concept Evaluation (PLACE) program was to identify the key technology requirements of earth resources satellite systems for the 1985-2000 period. The program involved four efforts: (1) examination of future needs in the earth resources area, (2) creation of a space systems technology model capable of satisfying these needs, (3) identification of key technology requirements posed by this model, and (4) development of a methodology (PRISM) to assist in the priority structuring of the resulting technologies.

  7. Design of DIII-D advanced divertor

    International Nuclear Information System (INIS)

    Smith, J.P.; Baxi, C.B.; Reis, E.; Schaffer, M.; Thruston, G.

    1989-01-01

    The Advanced Divertor is a modification being designed for the plasma chamber of the DIII-D tokamak in order to optimize the divertor configuration and allow a broader range of experiments to be carried out. The Advanced Divertor will enable two classes of physics experiments to be run in DIII-D: Divertor biasing and Divertor baffing. The Advanced Divertor has two principal components: ( 1) a toroidally symmetric baffle; and (2) a continuous ring electrode. The tokamak can be run in baffle, bias, or standard DIII-D divertor modes by accurate positioning of the outer divertor strike point through the use of the DIII-D plasma control system. The baffle will contain approximately 50,000 l/s pumping for particle removal in the outer bottom corner of the vacuum vessel. The strike point will be positioned at the entrance aperture for the baffle mode. The aperture geometry is designed to facilitate a large particle influx plus a high probability that backstreaming particles will be reionized and redirected to the aperture. Where the baffling plates meet, gas sealing is required to prevent recycling of neutrals back into the plasma. The electrode is a continuous water-cooled ring, armored with graphite. The ring is electrically isolated from the vessel wall and is biasable to 1 kV and 20 kA. The outer leg of the divertor will be positioned on the graphite covered ring during biasing experiments. The supports for the ring are radially flexible to handle the differential thermal growth between the ring and the vessel wall but stiff in the vertical direction to restrain the ring against large disruption forces. The coolant and electrical feeds are designed in a similar manner. 2 refs., 4 figs

  8. Design of DIII-D Advanced Divertor

    International Nuclear Information System (INIS)

    Smith, J.P.; Baxi, C.B.; Reis, E.; Schaffer, M.; Thurston, G.

    1989-11-01

    The Advanced Divertor is a modification being designed for the plasma chamber of the DIII-D tokamak in order to optimize the divertor configuration and allow a broader range of experiments to be carried out. The Advanced Divertor will enable two classes of physics experiments to be run in DIII-D: Divertor biasing and Divertor baffling. The Advanced Divertor has two principal components: a toroidally symmetric baffle; and a continuous ring electrode. The tokamak can be run in baffle, bias, or standard DIII-D divertor modes by accurate positioning of the outer divertor strike point through the use of the DIII-D plasma control system. The baffle will contain approximately 50,000 l/s pumping for particle removal in the outer bottom corner of the vacuum vessel. The strike point will be positioned at the entrance aperture for the baffle mode. The aperture geometry is designed to facilitate a large particle influx plus a high probability that backstreaming particles will be reionized and redirected to the aperture. Where the baffling plates meet, gas sealing is required to prevent recycling of neutrals back into the plasma. The electrode is a continuous water-cooled ring, armored with graphite. The ring is electrically isolated from the vessel wall and is biasable to 1 kV and 20 kA. The outer leg of the divertor will be positioned on the graphite covered ring during biasing experiments. The supports for the ring are radially flexible to handle the differential thermal growth between the ring and the vessel wall but stiff in the vertical direction to restrain the ring against large disruption forces. The coolant and electrical feeds are designed in a similar manner. All the feeds are supported from and maintain a 5 kV isolation to the vessel wall. 2 refs., 4 figs

  9. Improving Decision Making for Feeding Options in Advanced Dementia: A Randomized, Controlled Trial

    Science.gov (United States)

    Hanson, Laura C.; Carey, Timothy S.; Caprio, Anthony J.; Lee, Tae Joon; Ersek, Mary; Garrett, Joanne; Jackman, Anne; Gilliam, Robin; Wessell, Kathryn; Mitchell, Susan L.

    2011-01-01

    Background Feeding problems are common in dementia, and decision-makers have limited understanding of treatment options. Objectives To test whether a decision aid improves quality of decision-making about feeding options in advanced dementia. Design Cluster randomized controlled trial. Setting 24 nursing homes in North Carolina Participants Residents with advanced dementia and feeding problems and their surrogates. Intervention Intervention surrogates received an audio or print decision aid on feeding options in advanced dementia. Controls received usual care. Measurements Primary outcome was the Decisional Conflict Scale (range 1–5) measured at 3 months; other main outcomes were surrogate knowledge, frequency of communication with providers, and feeding treatment use. Results 256 residents and surrogate decision-makers were recruited. Residents’ average age was 85; 67% were Caucasian and 79% were women. Surrogates’ average age was 59; 67% were Caucasian, and 70% were residents’ children. The intervention improved knowledge scores (16.8 vs 15.1, paid about feeding options in advanced dementia reduced decisional conflict for surrogates and increased their knowledge and communication about feeding options with providers. PMID:22091750

  10. Alzheimer's disease - input of vitamin D with mEmantine assay (AD-IDEA trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Gautier Jennifer

    2011-10-01

    Full Text Available Abstract Background Current treatments for Alzheimer's disease and related disorders (ADRD are symptomatic and can only temporarily slow down ADRD. Future possibilities of care rely on multi-target drugs therapies that address simultaneously several pathophysiological processes leading to neurodegeneration. We hypothesized that the combination of memantine with vitamin D could be neuroprotective in ADRD, thereby limiting neuronal loss and cognitive decline. The aim of this trial is to compare the effect after 24 weeks of the oral intake of vitamin D3 (cholecalciferol with the effect of a placebo on the change of cognitive performance in patients suffering from moderate ADRD and receiving memantine. Methods The AD-IDEA Trial is a unicentre, double-blind, randomized, placebo-controlled, intent-to-treat, superiority trial. Patients aged 60 years and older presenting with moderate ADRD (i.e., Mini-Mental State Examination [MMSE] score between 10-20, hypovitaminosis D (i.e., serum 25-hydroxyvitamin D [25OHD] Discussion The combination of memantine plus vitamin D may represent a new multi-target therapeutic class for the treatment of ADRD. The AD-IDEA Trial seeks to provide evidence on its efficacy in limiting cognitive and functional declines in ADRD. Trial Registration ClinicalTrials.gov number, NCT01409694

  11. Vitamin D Status in Patients With Stage IV Colorectal Cancer: Findings From Intergroup Trial N9741

    Science.gov (United States)

    Ng, Kimmie; Sargent, Daniel J.; Goldberg, Richard M.; Meyerhardt, Jeffrey A.; Green, Erin M.; Pitot, Henry C.; Hollis, Bruce W.; Pollak, Michael N.; Fuchs, Charles S.

    2011-01-01

    Purpose Previous studies have suggested that higher plasma 25-hydroxyvitamin D3 [25(OH)D] levels are associated with decreased colorectal cancer risk and improved survival, but the prevalence of vitamin D deficiency in advanced colorectal cancer and its influence on outcomes are unknown. Patients and Methods We prospectively measured plasma 25(OH)D levels in 515 patients with stage IV colorectal cancer participating in a randomized trial of chemotherapy. Vitamin D deficiency was defined as 25(OH)D lower than 20 ng/mL, insufficiency as 20 to 29 ng/mL, and sufficiency as ≥ 30 ng/mL. We examined the association between baseline 25(OH)D level and selected patient characteristics. Cox proportional hazards models were used to calculate hazard ratios (HR) for death, disease progression, and tumor response, adjusted for prognostic factors. Results Among 515 eligible patients, 50% of the study population was vitamin D deficient, and 82% were vitamin D insufficient. Plasma 25(OH)D levels were lower in black patients compared to white patients and patients of other race (median, 10.7 v 21.1 v 19.3 ng/mL, respectively; P < .001), and females compared to males (median, 18.3 v 21.7 ng/mL, respectively; P = .0005). Baseline plasma 25(OH)D levels were not associated with patient outcome, although given the distribution of plasma levels in this cohort, statistical power for survival analyses were limited. Conclusion Vitamin D deficiency is highly prevalent among patients with stage IV colorectal cancer receiving first-line chemotherapy, particularly in black and female patients. PMID:21422438

  12. Interpreting clinical trial results by deductive reasoning: In search of improved trial design.

    Science.gov (United States)

    Kurbel, Sven; Mihaljević, Slobodan

    2017-10-01

    Clinical trial results are often interpreted by inductive reasoning, in a trial design-limited manner, directed toward modifications of the current clinical practice. Deductive reasoning is an alternative in which results of relevant trials are combined in indisputable premises that lead to a conclusion easily testable in future trials. © 2017 WILEY Periodicals, Inc.

  13. A parallel-group randomized clinical trial of individually tailored, multidisciplinary, palliative rehabilitation for patients with newly diagnosed advanced cancer

    DEFF Research Database (Denmark)

    Nottelmann, Lise; Groenvold, Mogens; Vejlgaard, Tove Bahn

    2017-01-01

    BACKGROUND: The effect of early palliative care and rehabilitation on the quality of life of patients with advanced cancer has been only sparsely described and needs further investigation. In the present trial we combine elements of early, specialized palliative care with cancer rehabilitation...... in a 12-week individually tailored, palliative rehabilitation program initiated shortly after a diagnosis of advanced cancer. METHODS: This single center, randomized, controlled trial will include 300 patients with newly diagnosed advanced cancer recruited from the Department of Oncology, Vejle Hospital...... initiated shortly after an advanced cancer diagnosis. The study will contribute with evidence on the effectiveness of implementing early palliative care in standard oncology treatment and hopefully offer new knowledge and future directions as to the content of palliative rehabilitation programs. TRIAL...

  14. Summary of major radiation fractionation and chemotherapy trials for organ preservation therapy in locally advanced head and neck squamous cell carcinoma.

    Science.gov (United States)

    Parsons, James T; Greene, Bruce D

    2015-01-01

    To review radiation fractionation and chemotherapy trials for patients undergoing organ preservation therapy for locally advanced head and neck squamous cell carcinoma. Radiation therapy fractionation and chemotherapy trial results as well as historical evidence are systematically reviewed. Trial results, which involve nearly 30,000 patients, have been interpreted, compared, and presented in a structured manner to demonstrate the changing approaches in treatment over the years from the 1960s to the present. The review includes data from the split-course radiation therapy era, meta-analyses of chemotherapy and radiation therapy fractionation trials, cetuximab trials, "triple-drug trials," and modern trials of induction chemotherapy followed by concomitant chemotherapy and radiation therapy. This summary will be useful to clinicians making treatment decisions today and to investigators designing trials in the future. Copyright © 2015 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

  15. Associations Between Vitamin D Intake and Progression to Incident Advanced Age-Related Macular Degeneration.

    Science.gov (United States)

    Merle, Bénédicte M J; Silver, Rachel E; Rosner, Bernard; Seddon, Johanna M

    2017-09-01

    There is growing evidence of the importance of nutrition in age-related macular degeneration (AMD), but no prospective studies have explored the impact of vitamin D. We evaluated the association between vitamin D intake and progression to advanced AMD. Among 2146 participants (3965 eyes), 541 (777 eyes) progressed from early or intermediate AMD to advanced disease (mean follow-up: 9.4 years) based on ocular imaging. Nutrients were log transformed and calorie adjusted. Survival analysis was used to assess associations between incident advanced disease and vitamin D intake. Neovascular disease (NV) and geographic atrophy (GA) were evaluated separately. Combined effects of dietary vitamin D and calcium were assessed based on high or low consumption of each nutrient. There was a lower risk of progression to advanced AMD in the highest versus lowest quintile of dietary vitamin D intake after adjustment for demographic, behavioral, ocular, and nutritional factors (hazard ratio [HR]: 0.60; 95% confidence interval [CI]: 0.43-0.83; P trend = 0.0007). Similar results were observed for NV (HR: 0.59; 95% CI: 0.39-0.89; P trend = 0.005) but not GA (HR: 0.83; 95% CI: 0.53-1.30; P trend = 0.35). A protective effect was observed for advanced AMD among participants with high vitamin D and low calcium compared to the group with low levels for each nutrient (HR: 0.67; 95% CI: 0.50-0.88; P = 0.005). When supplement use was considered, the effect was in the protective direction but was not significant. A diet rich in vitamin D may prevent or delay progression to advanced AMD, especially NV. Additional exploration is needed to elucidate the potential protective role of vitamin D and its contribution to reducing visual loss.

  16. Results of the gas carrier reliquefaction plant trial

    Directory of Open Access Journals (Sweden)

    Y. Fatyhov

    2007-12-01

    Full Text Available In the paper results of the gas carrier reliquefaction plant trial are considered. Safe transportation of liquefied gases is explained. The construction of the ship on trial is described. Designed parameters of the reliquefaction plant are presented. Heat gain into cargo tanks is obtained. Volumetric capacity, cooling capacity, volumetric efficiency and power consumption of the compressors are determined. Results of the main engine trial, diesel generator trial, reliquefaction plant trial, and calculations performed after wards are represented in five tables. The results obtained may be used for optimisation calculations of gas carriers’ reliquefaction plants.

  17. ORNL R and D on advanced small and medium power reactors: selected topics

    International Nuclear Information System (INIS)

    White, J.D.; Trauger, D.B.

    1989-01-01

    From 1984-1985, ORNL studied several innovative small and medium power nuclear concepts with respect to viability. Criteria for assessment of market attractiveness were developed and are described here. Using these criteria and descriptions of selected advanced reactor concepts, an assessment of their projected market viability in the time period 2000-2010 was made. All of these selected concepts could be considered as having the potential for meeting the criteria but, in most cases, considerable R and D would be required to reduce uncertainties. This work and later studies of safety and licensing of advanced, passively safe reactor concepts by ORNL are described. The results of these studies are taken into account in most of the current (FY 1989) work at ORNL on advanced reactors. A brief outline of this current work is given. One of the current R and D efforts at ORNL which addresses the operability and safety of advanced reactors is the Advanced Controls Program. Selected topics from this Program are described

  18. ORNL R and D on advanced small and medium power reactors: Selected topics

    International Nuclear Information System (INIS)

    White, J.D.; Trauger, D.B.

    1988-01-01

    From 1984-1985, ORNL studied several innovative small and medium power nuclear concepts with respect to viability. Criteria for assessment of market attractiveness were developed and are described here. Using these criteria and descriptions of selected advanced reactor concepts, and assessment of their projected market viability in the time period 2000-2010 was made. All of these selected concepts could be considered as having the potential for meeting the criteria but, in most cases, considerable RandD would be required to reduce uncertainties. This work and later studies of safety and licensing of advanced, passively safe reactor concepts by ORNL are described. The results of these studies are taken into account in most of the current (FY 1989) work at ORNL on advanced reactors. A brief outline of this current work is given. One of the current RandD efforts at ORNL which addresses the operability and safety of advanced reactors is the Advanced Controls Program. Selected topics from this Program are described. 13 refs., 1 fig

  19. Metronomic treatment of advanced non-small-cell lung cancer with daily oral vinorelbine – a Phase I trial

    Directory of Open Access Journals (Sweden)

    Guetz S

    2017-02-01

    Full Text Available Sylvia Guetz,1,* Amanda Tufman,2,* Joachim von Pawel,3 Achim Rittmeyer,4 Astrid Borgmeier,2 Pierre Ferré,5 Birgit Edlich,6 Rudolf Maria Huber2 1Ev. Diakonissenkrankenhaus Leipzig, Leipzig, 2University Hospital Munich and Thoracic Oncology Centre Munich, Member of the German Center for Lung Research, Comprehensive Pneumology Center Munich (DZL CPC-M, Munich, 3Asklepios Fachkliniken Muenchen-Gauting, Gauting, 4Lungenfachklinik Immenhausen, Immenhausen, Germany; 5Pierre Fabre Pharmaceuticals, Oncology Research and Development Center, Toulouse, France; 6Pierre Fabre Pharma GmbH, Freiburg, Germany *These authors contributed equally to this work Micro-abstract: In a Phase I dose-finding study of metronomic daily oral vinorelbine in advanced non-small-cell lung cancer, a recommended dose was established for this therapeutic approach. In addition, this trial revealed promising efficacy data and an acceptable tolerability profile. The observed vinorelbine blood concentrations suggest continuous anti-angiogenic coverage. Introduction: We present a Phase I dose-finding study investigating metronomic daily oral vinorelbine (Navelbine® Oral, NVBo in advanced non-small-cell lung cancer (NSCLC. Patients and methods: Patients with stage III/IV NSCLC received daily NVBo at fixed dose levels of 20–50 mg/d for 21 days of each 4-week cycle. Primary end point was the maximum tolerated dose. Secondary end points included tumor response, time to progression (TTP, overall survival (OS and tolerability. Results: Twenty-seven patients with advanced NSCLC were enrolled. Most of them were extensively pretreated. Daily NVBo was well tolerated up to 30 mg/d. At 40 mg/d, two of five patients experienced dose-limiting toxicities (DLTs. Three of six patients had DLTs at the 50 mg/d level. The recommended dose was established at 30 mg/d in cycle 1, with escalation to 40 mg/d in cycle 2, if tolerated. Pharmacokinetic analyses showed continuous blood exposure over 21

  20. Advanced tokamak research in DIII-D

    International Nuclear Information System (INIS)

    Greenfield, C M; Murakami, M; Ferron, J R

    2004-01-01

    Advanced tokamak (AT) research in DIII-D seeks to provide a scientific basis for steady-state high performance operation in future devices. These regimes require high toroidal beta to maximize fusion output and high poloidal beta to maximize the self-driven bootstrap current. Achieving these conditions requires integrated, simultaneous control of the current and pressure profiles and active magnetohydrodynamic stability control. The building blocks for AT operation are in hand. Resistive wall mode stabilization by plasma rotation and active feedback with non-axisymmetric coils allows routine operation above the no-wall beta limit. Neoclassical tearing modes are stabilized by active feedback control of localized electron cyclotron current drive (ECCD). Plasma shaping and profile control provide further improvements. Under these conditions, bootstrap supplies most of the current. Steady-state operation requires replacing the remaining inductively driven current, mostly located near the half radius, with non-inductive external sources. In DIII-D this current is provided by ECCD, and nearly stationary AT discharges have been sustained with little remaining inductive current. Fast wave current drive is being developed to control the central magnetic shear. Density control, with divertor cryopumps, of AT discharges with ELMing H-mode edges facilitates high current drive efficiency at reactor relevant collisionalities. An advanced plasma control system allows integrated control of these elements. Close coupling between modelling and experiment is key to understanding the separate elements, their complex nonlinear interactions, and their integration into self-consistent high performance scenarios. This approach has resulted in fully non-inductively driven plasmas with β N ≤ 3.5 and β T ≤ 3.6% sustained for up to 1 s, which is approximately equal to one current relaxation time. Progress in this area, and its implications for next-step devices, will be illustrated by

  1. 3D data processing with advanced computer graphics tools

    Science.gov (United States)

    Zhang, Song; Ekstrand, Laura; Grieve, Taylor; Eisenmann, David J.; Chumbley, L. Scott

    2012-09-01

    Often, the 3-D raw data coming from an optical profilometer contains spiky noises and irregular grid, which make it difficult to analyze and difficult to store because of the enormously large size. This paper is to address these two issues for an optical profilometer by substantially reducing the spiky noise of the 3-D raw data from an optical profilometer, and by rapidly re-sampling the raw data into regular grids at any pixel size and any orientation with advanced computer graphics tools. Experimental results will be presented to demonstrate the effectiveness of the proposed approach.

  2. Clinical Trials

    Medline Plus

    Full Text Available ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ... All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical ...

  3. Advanced Bioinks for 3D Printing: A Materials Science Perspective.

    Science.gov (United States)

    Chimene, David; Lennox, Kimberly K; Kaunas, Roland R; Gaharwar, Akhilesh K

    2016-06-01

    Advanced bioinks for 3D printing are rationally designed materials intended to improve the functionality of printed scaffolds outside the traditional paradigm of the "biofabrication window". While the biofabrication window paradigm necessitates compromise between suitability for fabrication and ability to accommodate encapsulated cells, recent developments in advanced bioinks have resulted in improved designs for a range of biofabrication platforms without this tradeoff. This has resulted in a new generation of bioinks with high print fidelity, shear-thinning characteristics, and crosslinked scaffolds with high mechanical strength, high cytocompatibility, and the ability to modulate cellular functions. In this review, we describe some of the promising strategies being pursued to achieve these goals, including multimaterial, interpenetrating network, nanocomposite, and supramolecular bioinks. We also provide an overview of current and emerging trends in advanced bioink synthesis and biofabrication, and evaluate the potential applications of these novel biomaterials to clinical use.

  4. Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions.

    Directory of Open Access Journals (Sweden)

    Stephanie Coronado-Montoya

    Full Text Available A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified.CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses.108 (87% of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88% concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7. Of 21 trial registrations, 13 (62% remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases.The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

  5. Deep brain stimulation targeting the fornix for mild Alzheimer dementia: design of the ADvance randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Holroyd KB

    2015-07-01

    stimulation (DBS of memory circuits may improve symptoms and possibly slow disease progression. The ADvance trial was designed to examine DBS of the fornix as a treatment for mild AD. Methods: ADvance is a randomized, double-blind, placebo-controlled, delayed-start, multicenter clinical trial conducted at six sites in the US and one site in Canada. Eighty-five subjects initially consented to be screened for the trial. Of these, 42 subjects who met inclusion and exclusion criteria were implanted with DBS leads anterior to the columns of the fornix bilaterally. They were randomized 1:1 to DBS “off” or DBS “on” groups for the initial 12 months of follow-up. After 1 year, all subjects will have their devices turned “on” for the remainder of the study. Postimplantation, subjects will return for 13 follow-up visits over 48 months for cognitive and psychiatric assessments, brain imaging (up to 12 months, and safety monitoring. The primary outcome measures include Alzheimer's Disease Assessment Scale – cognitive component (ADAS-cog-13, Clinical Dementia Rating sum of boxes (CDR-SB, and cerebral glucose metabolism measured with positron emission tomography. This report details the study methods, baseline subject characteristics of screened and implanted participants, and screen-to-baseline test–retest reliability of the cognitive outcomes. Results: Implanted subjects had a mean age of 68.2 years, were mostly male (55%, and had baseline mean ADAS-cog-13 and CDR-SB scores of 28.9 (SD, 5.2 and 3.9 (SD, 1.6, respectively. There were no significant differences between screened and implanted or nonimplanted subjects on most demographic or clinical assessments. Implanted subjects had significantly lower (better ADAS-cog-11 (17.5 vs 21.1 scores, but did not differ on CDR-SB. Scores on the major outcome measures for the trial were consistent at screening and baseline. Conclusion: ADvance was successful in enrolling a substantial group of patients for this novel application of

  6. Advances in 3D neuronal cell culture

    NARCIS (Netherlands)

    Frimat, Jean Philippe; Xie, Sijia; Bastiaens, Alex; Schurink, Bart; Wolbers, Floor; Den Toonder, Jaap; Luttge, Regina

    2015-01-01

    In this contribution, the authors present our advances in three-dimensional (3D) neuronal cell culture platform technology contributing to controlled environments for microtissue engineering and analysis of cellular physiological and pathological responses. First, a micromachined silicon sieving

  7. Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

    Science.gov (United States)

    Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

    2017-12-01

    Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (ppublication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

  8. TIMP-1 and responsiveness to gemcitabine in advanced breast cancer

    DEFF Research Database (Denmark)

    Jørgensen, Charlotte Levin Tykjær; Bjerre, Christina Annette; Ejlertsen, Bent Laursen

    2014-01-01

    receiving GD. CONCLUSIONS: TIMP-1 status was an independent prognostic factor for OS but not TTP in patients with advanced breast cancer receiving either D or GD. There was no statistically significant interaction between TIMP-1 status and treatment, but a trend towards an incremental OS from the addition...... and predictive marker in advanced breast cancer patients receiving docetaxel (D) or gemcitabine plus docetaxel (GD). METHODS: Patients with locally advanced or metastatic breast cancer who were assigned to D or GD by participation in a randomized phase III trial were included in the study. Assessment of TIMP-1...

  9. Sunlight exposure or vitamin D supplementation for vitamin D-deficient non-western immigrants: a randomized clinical trial

    NARCIS (Netherlands)

    Wicherts, I.S.; Boeke, A.J.P.; van der Meer, I.M.; van Schoor, N.M.; Knol, D.L.; Lips, P.T.A.M.

    2011-01-01

    Summary: Vitamin D deficiency is very common in non-western immigrants. In this randomized clinical trial, vitamin D 800 IU/day or 100,000 IU/3 months were compared with advised sunlight exposure. Vitamin D supplementation was more effective than advised sunlight exposure in improving vitamin D

  10. Limited role of culture conversion for decision-making in individual patient care and for advancing novel regimens to confirmatory clinical trials.

    Science.gov (United States)

    Phillips, Patrick P J; Mendel, Carl M; Burger, Divan A; Crook, Angela M; Crook, Angela; Nunn, Andrew J; Dawson, Rodney; Diacon, Andreas H; Gillespie, Stephen H

    2016-02-04

    Despite recent increased clinical trials activity, no regimen has proved able to replace the standard 6-month regimen for drug-sensitive tuberculosis. Understanding the relationship between microbiological markers measured during treatment and long-term clinical outcomes is critical to evaluate their usefulness for decision-making for both individual patient care and for advancing novel regimens into time-consuming and expensive pivotal phase III trials. Using data from the randomized controlled phase III trial REMoxTB, we evaluated sputum-based markers of speed of clearance of bacilli: time to smear negative status; time to culture negative status on LJ or in MGIT; daily rate of change of log10(TTP) to day 56; and smear or culture results at weeks 6, 8 or 12; as individual- and trial-level surrogate endpoints for long-term clinical outcome. Time to culture negative status on LJ or in MGIT, time to smear negative status and daily rate of change in log10(TTP) were each independent predictors of clinical outcome, adjusted for treatment (p limited role in decision-making for advancing regimens into phase III trials or in predicting the outcome of treatment for individual patients. REMoxTB ClinicalTrials.gov number: NCT00864383.

  11. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial.

    Science.gov (United States)

    Wells, Samuel A; Robinson, Bruce G; Gagel, Robert F; Dralle, Henning; Fagin, James A; Santoro, Massimo; Baudin, Eric; Elisei, Rossella; Jarzab, Barbara; Vasselli, James R; Read, Jessica; Langmuir, Peter; Ryan, Anderson J; Schlumberger, Martin J

    2012-01-10

    There is no effective therapy for patients with advanced medullary thyroid carcinoma (MTC). Vandetanib, a once-daily oral inhibitor of RET kinase, vascular endothelial growth factor receptor, and epidermal growth factor receptor signaling, has previously shown antitumor activity in a phase II study of patients with advanced hereditary MTC. Patients with advanced MTC were randomly assigned in a 2:1 ratio to receive vandetanib 300 mg/d or placebo. On objective disease progression, patients could elect to receive open-label vandetanib. The primary end point was progression-free survival (PFS), determined by independent central Response Evaluation Criteria in Solid Tumors (RECIST) assessments. Between December 2006 and November 2007, 331 patients (mean age, 52 years; 90% sporadic; 95% metastatic) were randomly assigned to receive vandetanib (231) or placebo (100). At data cutoff (July 2009; median follow-up, 24 months), 37% of patients had progressed and 15% had died. The study met its primary objective of PFS prolongation with vandetanib versus placebo (hazard ratio [HR], 0.46; 95% CI, 0.31 to 0.69; P < .001). Statistically significant advantages for vandetanib were also seen for objective response rate (P < .001), disease control rate (P = .001), and biochemical response (P < .001). Overall survival data were immature at data cutoff (HR, 0.89; 95% CI, 0.48 to 1.65). A final survival analysis will take place when 50% of the patients have died. Common adverse events (any grade) occurred more frequently with vandetanib compared with placebo, including diarrhea (56% v 26%), rash (45% v 11%), nausea (33% v 16%), hypertension (32% v 5%), and headache (26% v 9%). Vandetanib demonstrated therapeutic efficacy in a phase III trial of patients with advanced MTC (ClinicalTrials.gov NCT00410761).

  12. Final Report for SERDP Project RC-1649: Advanced Chemical Measurements of Smoke from DoD-prescribed Burns

    Science.gov (United States)

    T.J. Johnson; R.J. Yokelson; S.K. Akagi; I.R. Burling; D.R. Weise; S.P. Urbanski; C.E. Stockwell; J. Reardon; E.N. Lincoln; L.T.M. Profeta; A. Mendoza; M.D.W. Schneider; R.L. Sams; S.D. Williams; C.E. Wold; D.W.T. Griffith; M. Cameron; J.B. Gilman; C. Warneke; J.M. Roberts; P. Veres; W.C. Kuster; J de Gouw

    2014-01-01

    Project RC-1649, "Advanced Chemical Measurement of Smoke from DoD-prescribed Burns" was undertaken to use advanced instrumental techniques to study in detail the particulate and vapor-phase chemical composition of the smoke that results from prescribed fires used as a land management tool on DoD bases, particularly bases in the southeastern U.S. The statement...

  13. Advancing community stakeholder engagement in biomedical HIV prevention trials: principles, practices and evidence.

    Science.gov (United States)

    Newman, Peter A; Rubincam, Clara

    2014-12-01

    Community stakeholder engagement is foundational to fair and ethically conducted biomedical HIV prevention trials. Concerns regarding the ethical engagement of community stakeholders in HIV vaccine trials and early terminations of several international pre-exposure prophylaxis trials have fueled the development of international guidelines, such as UNAIDS' good participatory practice (GPP). GPP aims to ensure that stakeholders are effectively involved in all phases of biomedical HIV prevention trials. We provide an overview of the six guiding principles in the GPP and critically examine them in relation to existing social and behavioral science research. In particular, we highlight the challenges involved in operationalizing these principles on the ground in various global contexts, with a focus on low-income country settings. Increasing integration of social science in biomedical HIV prevention trials will provide evidence to advance a science of community stakeholder engagement to support ethical and effective practices informed by local realities and sociocultural differences.

  14. ADVANCED TOKAMAK OPERATION USING THE DIII-D PLASMA CONTROL SYSTEM

    International Nuclear Information System (INIS)

    HUMPHREYS, DA; FERRON, JR; GAROFALO, AM; HYATT, AW; JERNIGAN, TC; JOHNSON, RD; LAHAYE, RJ; LEUER, JA; OKABAYASHI, M; PENAFLOR, BG; SCOVILLE, JT; STRAIT, EJ; WALKER, ML; WHYTE, DG

    2002-01-01

    A271 ADVANCED TOKAMAK OPERATION USING THE DIII-D PLASMA CONTROL SYSTEM. The principal focus of experimental operations in the DIII-D tokamak is the advanced tokamak (AT) regime to achieve, which requires highly integrated and flexible plasma control. In a high performance advanced tokamak, accurate regulation of the plasma boundary, internal profiles, pumping, fueling, and heating must be well coordinated with MHD control action to stabilize such instabilities as tearing modes and resistive wall modes. Sophisticated monitors of the operational regime must provide detection of off-normal conditions and trigger appropriate safety responses with acceptable levels of reliability. Many of these capabilities are presently implemented in the DIII-D plasma control system (PCS), and are now in frequent or routine operational use. The present work describes recent development, implementation, and operational experience with AT regime control elements for equilibrium control, MHD suppression, and off-normal event detection and response

  15. Vitamin D and health: the need for more randomized controlled trials.

    Science.gov (United States)

    Jorde, Rolf; Grimnes, Guri

    2015-04-01

    The importance of vitamin D for calcium absorption and bone health is undisputed. In addition, vitamin D may also be important for more than the skeleton as low serum levels of 25-hydroxyvitamin D (25(OH)D) have been associated with a number of diseases like cardiovascular disease, diabetes, cancer and infections. This is mainly based on observational studies and proof of causal relations from randomized controlled trials (RCTs) are lacking. At present several large RCTs including from 2152 to 25,000 subjects and with cardiovascular disease and cancer as endpoints are ongoing. Results are expected within 3-5 years, and hopefully these studies will give us a definite answer on need for vitamin D supplementation. However, since vitamin D deficiency (serum 25(OH)D vitamin D in truly vitamin D deficient subjects, studies that in retrospect obviously should have been the starting point for RCTs on vitamin D and health. This article is part of a Special Issue entitled '17th Vitamin D Workshop'. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. Clinical tests analysis; Analyses d'essai clinique

    Energy Technology Data Exchange (ETDEWEB)

    DeSilvio, M.; Valicenti, R.; Grignon, D.; O' Asbell, S.; Colleen Lawton, Ch.R.; Thomas, J.R.; William, S.; Abrious, S.; Lang, P.; Baujat, B.; Aufry, H.; Bourhis, J.; Chan, A.; Onat, H.; Chua, D.; Mazeron, R.; Gerard, J.P.; Conroy, T.; Bonnetain, F.; Bouche, O.; Chapet, O.; Closon-Dejardin, M.T.; Berges, O.; Bijker, N.; Meijnen, P.; Peterse, J.L.; Bogaerts, J.; Van Hoorebeeck, I.; Julien, J.P.; Ontkova, M.; Bosset, J.F.; Collette, L.; Calais, G.; Mineur, L.; Maingon, P.; Radosevic-Jelic, L.; Boostan, H.; Nielsen, H.M.; Overgaard, M.; Grau, C.; Jensen, A.R.; Overgaard, J.; Beneyton, V.; Noel, G

    2007-05-15

    The different subjects treated in this analysis are as follow: Whole-pelvis, 'mini-pelvis' or prostate only external beam radiotherapy after neo-adjuvant and concurrent hormonal therapy in patients treated in the radiation therapy oncology group 9413 trial; chemotherapy in locally advanced nasopharyngeal carcinoma: an individual patient data meta-analysis of eight randomized trials and 1753 patients; preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of F.F.C.D. 9203; breast-conservative treatment with or without radiotherapy in ductal carcinoma-in-situ: ten year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 1085. A study by the E.O.R.T.C. Breast Cancer Cooperative Group and E.O.R.T.C. Radiotherapy Group; chemotherapy with preoperative radiotherapy in rectal cancer; locoregional recurrence after mastectomy in high-risk breast cancer-risk and prognosis. An analysis of patients from the D.B.C.G. 82 b and c randomization trials. (N.C.)

  17. Advanced 3D Object Identification System, Phase I

    Data.gov (United States)

    National Aeronautics and Space Administration — Optra will build an Advanced 3D Object Identification System utilizing three or more high resolution imagers spaced around a launch platform. Data from each imager...

  18. JAEA key facilities for global advanced fuel cycle R and D

    Energy Technology Data Exchange (ETDEWEB)

    Nomura, Shigeo; Yamamoto, Ryuichi [Nuclear Fuel Cycle Engineering Labos, JAEA, 4-33 Tokai-mura, Ibaraki, 319-1194 (Japan)

    2008-07-01

    Advanced fuel cycle will be realized with the mid and long term R and D during the long-term transition period from LWR cycle to advanced reactor fuel cycle. Most of JAEA facilities have been utilized to establish the current LWR and FBR (Fast Breeder Reactor) fuel cycle by implementing evolutionary R and D. An assessment of today's state experimental facilities concerning the following research issues: reprocessing, Mox fuel fabrication, irradiation and post-irradiation examination, waste management and nuclear data measurement, is made. The revolutionary R and D requests new issues to be studied: the TRU multi-recycling, minor actinide recycling, the assessment of proliferation resistance and the assessment of cost reduction. To implement the revolutionary R and D for advanced fuel cycle, however, these facilities should be refurbished to install new machines and process equipment to provide more flexible testing parameters.

  19. Somatostatin receptor scintigraphy in advanced renal cell carcinoma. Results of a phase II-trial of somatostatine analogue therapy in patients with advanced RCC

    International Nuclear Information System (INIS)

    Freudenberg, L.S.; Goerges, R.; Stergar, H.; Bockisch, A.; Gauler, T.; Bauer, S.; Antoch, G.; Schuette, J.

    2008-01-01

    Aims: objective of this prospective study was to evaluate the role of somatostatin receptor scintigraphy (SRS) in advanced renal cell carcinoma (RCC) with respect to potential therapy with somatostatin analogue (SST-A) and to assess the response rate under therapy with SST-A. Patients, methods: 16 patients with documented progression of histologically confirmed advanced RCC were included. Planar whole-body SRS was performed 4, 24 and 48h post i.v. injection of 175-200 MBq 111 In-pentetreoide. 5 and 25 h p.i. SPECT of thorax and abdomen were performed. Documentation of somatostatin receptor expression via SRS in > 50% of known tumour lesions was the criteria for treatment start with SST-A (Sandostatin LAR registered -Depot 30mg i.m. every four weeks). Results: in 9/16 of the patients SRS showed at least one metastasis with moderate (n = 5) or intense (n = 4) tracer uptake. Lesion-based SRS evaluation showed only 12.1% (20/165) of all metastases. Most false-negative lesions were located in the lungs. In too patients, the majority of the known metastases was SRS positive and these patients received SST-A therapy. The first radiographic evaluation after a two-month interval showed progressive disease in both patients. Conclusions: we conclude that SRS is of limited value in staging of advanced RCC. In our patients SST-A did not result in a growth control of RCC. Consequently, the use of SST-A in advanced RCC seems to be no relevant therapeutic option. (orig.)

  20. Recent advances in 3D computed tomography techniques for simulation and navigation in hepatobiliary pancreatic surgery.

    Science.gov (United States)

    Uchida, Masafumi

    2014-04-01

    A few years ago it could take several hours to complete a 3D image using a 3D workstation. Thanks to advances in computer science, obtaining results of interest now requires only a few minutes. Many recent 3D workstations or multimedia computers are equipped with onboard 3D virtual patient modeling software, which enables patient-specific preoperative assessment and virtual planning, navigation, and tool positioning. Although medical 3D imaging can now be conducted using various modalities, including computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and ultrasonography (US) among others, the highest quality images are obtained using CT data, and CT images are now the most commonly used source of data for 3D simulation and navigation image. If the 2D source image is bad, no amount of 3D image manipulation in software will provide a quality 3D image. In this exhibition, the recent advances in CT imaging technique and 3D visualization of the hepatobiliary and pancreatic abnormalities are featured, including scan and image reconstruction technique, contrast-enhanced techniques, new application of advanced CT scan techniques, and new virtual reality simulation and navigation imaging. © 2014 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

  1. Results of a phase II trial of external beam radiation with etanidazole (SR 2508) for the treatment of locally advanced prostate cancer (RTOG protocol 90-20)

    International Nuclear Information System (INIS)

    Lawton, Colleen A.; Coleman, C. Norman; Buzydlowski, Jan W.; Forman, Jeffrey D.; Marcial, Victor A.; DelRowe, John D.; Rotman, Marvin

    1996-01-01

    Purpose: RTOG Protocol 90-20 was designed to evaluate the effect of the hypoxic cell sensitizer Etanidazole (SR-2508) on locally advanced adenocarcinoma of the prostate treated with concurrent external beam irradiation. Methods and Materials: Patients with biopsy-proven adenocarcinoma of the prostate with locally advanced T 2b , T 3 , and T 4 tumors were eligible for this study. No patients with disease beyond the pelvis were eligible. Serum prostate specific antigen (PSA) was mandatory. All patients received definitive external beam irradiation using standard four-field whole pelvis treatment to 45-50 Gy, followed by a cone down with a minimum total dose to the prostate of 66 Gy at 1.8-2.0 Gy/fraction over 6.5-7.5 weeks. Etanidazole was delivered 1.8 g/m 2 given 3 times a week to a total of 34.2 g/m 2 or 19 doses. Results: Thirty-nine patients were entered onto the study. Three patients refused treatment; therefore, 36 patients were eligible for further evaluation. Median follow-up was 36.9 months from treatment end. All patients had elevated initial PSA levels, and 18 patients had PSAs of > 20 ng/ml. Tumor classification was T 2 , 12 patients (33.3%); T 3 , 22 patients (61.1%); and T 4 , 2 patients (5.6%). Complete clinical response, defined as PSA < 4 ng/ml and complete clinical disappearance, was attained in 17.9% of ((5(28)) pts) with information at 90 days and 56% of patients by 12 months following treatment. Relapse-free survival was 13% at 3 years with PSA < 4 ng/ml. There were no Grade 4 or 5 toxicities, either acute (during treatment) or in follow-up. Conclusions: Results of this trial regarding PSA response and clinical disappearance of disease are similar to historical controls and do not warrant further investigation of etanidazole as was done in this trial. Drug toxicity that, in the past, has been unacceptably high with other hypoxic cell sensitizers does not appear to be a significant problem with this drug

  2. Preoperative chemotherapy versus chemoradiotherapy in locally advanced adenocarcinomas of the oesophagogastric junction (POET): Long-term results of a controlled randomised trial.

    Science.gov (United States)

    Stahl, Michael; Walz, Martin K; Riera-Knorrenschild, Jorge; Stuschke, Martin; Sandermann, Andreas; Bitzer, Michael; Wilke, Hansjochen; Budach, Wilfried

    2017-08-01

    Results of the PreOperative therapy in Esophagogastric adenocarcinoma Trial (POET) showed some benefits when including radiotherapy into the preoperative treatment. This article is reporting long-term results of this phase III study. Patients with locally advanced adenocarcinomas of the oesophagogastric junction (Siewert types I-III) were eligible. Randomisation was done to chemotherapy (group A) or induction chemotherapy and chemoradiotherapy (CRT; group B) followed by surgery. The primary end-point of the study was overall survival at 3 years. The study was closed early after 119 patients having been randomised and were eligible. Local progression-free survival after tumour resection was significantly improved by CRT (hazard ratio [HR] 0.37; 0.16-0.85, p = value 0.01) and 20 versus 12 patients were free of local tumour progression at 5 years (p = 0.03). Although the rate of postoperative in-hospital mortality was somewhat higher with CRT (10.2% versus 3.8%, p = 0.26), more patients were alive at 3 and 5 years after CRT (46.7% and 39.5%) compared with chemotherapy (26.1% and 24.4%). Thus, overall survival showed a trend in favour of preoperative CRT (HR 0.65, 95% confidence interval [CI] 0.42-1.01, p = 0.055). Although the primary end-point overall survival of the study was not met, our long-term follow-up data suggest a benefit in local progression-free survival when radiotherapy was added to preoperative chemotherapy in patients with locally advanced adenocarcinoma of the oesophagogastric junction. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. NHLBI's program for VAD therapy for moderately advanced heart failure: the REVIVE-IT pilot trial.

    Science.gov (United States)

    Baldwin, J Timothy; Mann, Douglas L

    2010-11-01

    Ventricular assist devices (VADs) are used to bridge heart failure patients to transplantation, to allow their own hearts to recover, or as permanent ("destination") therapy. To date, the use of VADs has been limited to late-stage heart failure patients because of the associated device risks. In 2008, a National Heart, Lung, and Blood Institute (NHLBI) working group met to evaluate the treatment of heart failure using VADs and to advise the institute on how therapy for heart failure may be best advanced by clinical trials involving the devices. Recognizing the improvements in VAD technology and in patient care and selection over the past decade, the working group recommended that a trial be performed to assess the use of chronic VAD therapy in patients who are less ill than those currently eligible for destination therapy. The hypothesis proposed for the trial is that VAD therapy may improve both survival and quality of life in moderately advanced heart failure patients who are neither inotrope-dependent nor exercise-intolerant and have not yet developed serious consequences such as malnourishment, end-organ damage, and immobility. Based on the group's recommendations, NHLBI issued an RFP in 2009 for the REVIVE-IT Pilot Trail, which will serve to test the hypothesis and inform the pivotal trial. Published by Elsevier Inc.

  4. Evaluation of the trial design studies for an advanced marine reactor, (2)

    International Nuclear Information System (INIS)

    Ambo, Noriaki; Yokomura, Takeyoshi.

    1988-03-01

    As for the CARAMEL fuel (plate-type fuel) that was the fuel of the integrated-type reactor which was one of the trial design studies for an Advanced Marine Reactor, its structure and its fuel specific characteristics were studied and compared with a fuel rod (cylindrical fuel), and the total characteristics of the caramel fuel was reviewed and evaluated. (author)

  5. The influence of innovation environments in R&D results

    Directory of Open Access Journals (Sweden)

    Serje Schmidt

    Full Text Available Abstract In Brazil, as well as worldwide, incubators and science and technology parks (ISTPs are continually used to foster regional development. However, the incongruence between the growing number of ISTPs and the inconclusiveness of their results raised preoccupations regarding their effectiveness and doubts on how they promote innovation. In spite of the growing possibility and need for quantitative research, few studies have adopted this methodological perspective. The objective of this study is to analyze the influence of resources promoted by ISTPs on the results of their tenant's R&D projects. A quantitative cross-sectional design was used in this study. A higher specificity in the observation and analysis of ISTPs contributed to the advance of literature, so that a taxonomy of resources promoted by ISTPs was proposed and the key resources associated to R&D results could be identified.

  6. Neural engineering from advanced biomaterials to 3D fabrication techniques

    CERN Document Server

    Kaplan, David

    2016-01-01

    This book covers the principles of advanced 3D fabrication techniques, stem cells and biomaterials for neural engineering. Renowned contributors cover topics such as neural tissue regeneration, peripheral and central nervous system repair, brain-machine interfaces and in vitro nervous system modeling. Within these areas, focus remains on exciting and emerging technologies such as highly developed neuroprostheses and the communication channels between the brain and prostheses, enabling technologies that are beneficial for development of therapeutic interventions, advanced fabrication techniques such as 3D bioprinting, photolithography, microfluidics, and subtractive fabrication, and the engineering of implantable neural grafts. There is a strong focus on stem cells and 3D bioprinting technologies throughout the book, including working with embryonic, fetal, neonatal, and adult stem cells and a variety of sophisticated 3D bioprinting methods for neural engineering applications. There is also a strong focus on b...

  7. Effects of Vitamin D Supplementation on Serum 25-Hydroxyvitamin D Concentrations in Cirrhotic Patients: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Stefan Pilz

    2016-05-01

    Full Text Available Background: The liver is crucial for 25-hydroxyvitamin D (25(OHD metabolism, and vitamin D deficiency is highly prevalent in patients with cirrhosis and predicts adverse outcomes. We aimed to evaluate whether vitamin D supplementation in patients with cirrhosis is effective in increasing 25(OHD serum concentrations. Secondary outcome measures included liver function tests (aspartate aminotransferase (AST, alanine aminotransferase (ALT, gamma glutamyltransferase (GGT, and alkaline phosphatase (AP, albumin, International Normalized Ratio (INR, bilirubin, the liver fibrosis marker hyaluronic acid, and parameters of mineral metabolism including parathyroid hormone (PTH. Methods: This is a double-center, double-blind, placebo-controlled study conducted from December 2013 to May 2014 at the Medical University of Graz, and the hospital Hoergas-Enzenbach, Austria. We enrolled 36 consecutive patients with cirrhosis and 25(OHD concentrations below 30 ng/mL. Study participants were randomly allocated to receive either 2800 International Units of vitamin D3 per day as oily drops (n = 18 or placebo (n = 18 for 8 weeks. Results: Thirty-three study participants (mean (SD age: 60 (9 years; 21% females; 25(OHD: 15.6 (7.4 ng/mL completed the trial. The mean treatment effect (95% CI for 25(OHD was 15.2 (8.0 to 22.4 ng/mL (p < 0.001. There was no significant effect on any secondary outcome. Conclusions: In this randomized controlled trial, vitamin D supplementation increases 25(OHD serum concentrations, even in cirrhotic patients.

  8. On reporting results from randomized controlled trials with recurrent events

    Directory of Open Access Journals (Sweden)

    Sobolev Boris G

    2008-05-01

    Full Text Available Abstract Background Evidence-based medicine has been advanced by the use of standards for reporting the design and methodology of randomized controlled trials (RCT. Indeed, without this information it is difficult to assess the quality of evidence from an RCT. Although a variety of statistical methods are available for the analysis of recurrent events, reporting the effect of an intervention on outcomes that recur is an area that remains poorly understood in clinical research. The purpose of this paper is to outline guidelines for reporting results from RCTs where the outcome of interest is a recurrent event. Methods We used a simulation study to relate an event process and results from analyses of the gamma-Poisson, independent-increment, conditional, and marginal Cox models. We reviewed the utility of regression models for the rate of a recurrent event by articulating the associated study questions, preenting the risk sets, and interpreting the regression coefficients. Results Based on a single data set produced by simulation, we reported and contrasted results from statistical methods for evaluating treatment effect from an RCT with a recurrent outcome. We showed that each model has different study questions, assumptions, risk sets, and rate ratio interpretation, and so inferences should consider the appropriateness of the model for the RCT. Conclusion Our guidelines for reporting results from an RCT involving a recurrent event suggest that the study question and the objectives of the trial, such as assessing comparable groups and estimating effect size, should determine the statistical methods. The guidelines should allow clinical researchers to report appropriate measures from an RCT for understanding the effect of intervention on the occurrence of a recurrent event.

  9. Printing, folding and assembly methods for forming 3D mesostructures in advanced materials

    Science.gov (United States)

    Zhang, Yihui; Zhang, Fan; Yan, Zheng; Ma, Qiang; Li, Xiuling; Huang, Yonggang; Rogers, John A.

    2017-03-01

    A rapidly expanding area of research in materials science involves the development of routes to complex 3D structures with feature sizes in the mesoscopic range (that is, between tens of nanometres and hundreds of micrometres). A goal is to establish methods for controlling the properties of materials systems and the function of devices constructed with them, not only through chemistry and morphology, but also through 3D architectures. The resulting systems, sometimes referred to as metamaterials, offer engineered behaviours with optical, thermal, acoustic, mechanical and electronic properties that do not occur in the natural world. Impressive advances in 3D printing techniques represent some of the most broadly recognized developments in this field, but recent successes with strategies based on concepts in origami, kirigami and deterministic assembly provide additional, unique options in 3D design and high-performance materials. In this Review, we highlight the latest progress and trends in methods for fabricating 3D mesostructures, beginning with the development of advanced material inks for nozzle-based approaches to 3D printing and new schemes for 3D optical patterning. In subsequent sections, we summarize more recent methods based on folding, rolling and mechanical assembly, including their application with materials such as designer hydrogels, monocrystalline inorganic semiconductors and graphene.

  10. Advances in 3D printing & additive manufacturing technologies

    CERN Document Server

    Pandey, Pulak; Kumar, L

    2017-01-01

    This edited volume comprises select chapters on advanced technologies for 3D printing and additive manufacturing and how these technologies have changed the face of direct, digital technologies for rapid production of models, prototypes and patterns. Because of its wide applications, 3D printing and additive manufacturing technology has become a powerful new industrial revolution in the field of manufacturing. The evolution of 3D printing and additive manufacturing technologies has changed design, engineering and manufacturing processes across industries such as consumer products, aerospace, medical devices and automotives. The objective of this book is to help designers, R&D personnel, and practicing engineers understand the state-of-the-art developments in the field of 3D Printing and Additive Manufacturing. .

  11. Publication and non-publication of drug trial results: a 10-year cohort of trials in Norwegian general practice.

    Science.gov (United States)

    Brænd, Anja Maria; Straand, Jørund; Jakobsen, Rune Bruhn; Klovning, Atle

    2016-04-11

    Previously, we identified a 10-year cohort of protocols from applications to the Norwegian Medicines Agency 1998-2007, consisting of 196 drug trials in general practice. The aim of this study was to examine whether trial results were published and whether trial funding and conflicts of interest were reported. Cohort study of trials with systematic searches for published results. Clinical drug trials in Norwegian general practice. We performed systematic literature searches of MEDLINE, Embase and CENTRAL to identify publications originating from each trial using characteristics such as test drug, comparator and patient groups as search terms. When no publication was identified, we contacted trial sponsors for information regarding trial completion and reference to any publications. We determined the frequency of publication of trial results and trial characteristics associated with publication of results. Of the 196 trials, 5 were never started. Of the remaining 191 trials, 71% had results published in a journal, 11% had results publicly available elsewhere and 18% of trials had no results available. Publication was more common among trials with an active comparator drug (χ(2) test, p=0.040), with a larger number of patients (total sample size≥median, p=0.010) and with a longer trial period (duration≥median, p=0.025). Trial funding was reported in 85% of publications and increased over time, as did reporting of conflicts of interest among authors. Among the 134 main journal articles from the trials, 60% presented statistically significant results for the investigational drug, and the conclusion of the article was favourable towards the test drug in 78% of papers. We did not identify any journal publication of results for 29% of the general practice drug trials. Trials with an active comparator, larger and longer trials were more likely to be published. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

  12. Chemotherapy in advanced ovarian cancer: four systematic meta-analyses of individual patient data from 37 randomized trials. Advanced Ovarian Cancer Trialists' Group.

    Science.gov (United States)

    Aabo, K.; Adams, M.; Adnitt, P.; Alberts, D. S.; Athanazziou, A.; Barley, V.; Bell, D. R.; Bianchi, U.; Bolis, G.; Brady, M. F.; Brodovsky, H. S.; Bruckner, H.; Buyse, M.; Canetta, R.; Chylak, V.; Cohen, C. J.; Colombo, N.; Conte, P. F.; Crowther, D.; Edmonson, J. H.; Gennatas, C.; Gilbey, E.; Gore, M.; Guthrie, D.; Yeap, B. Y.

    1998-01-01

    The purpose of this systematic study was to provide an up to date and reliable quantitative summary of the relative benefits of various types of chemotherapy (non-platinum vs platinum, single-agent vs combination and carboplatin vs cisplatin) in the treatment of advanced ovarian cancer. Also, to investigate whether well-defined patient subgroups benefit more or less from cisplatin- or carboplatin-based therapy. Meta-analyses were based on updated individual patient data from all available randomized controlled trials (published and unpublished), including 37 trials, 5667 patients and 4664 deaths. The results suggest that platinum-based chemotherapy is better than non-platinum therapy, show a trend in favour of platinum combinations over single-agent platinum, and suggest that cisplatin and carboplatin are equally effective. There is no good evidence that cisplatin is more or less effective than carboplatin in any particular subgroup of patients. Images Figure 1 Figure 2 Figure 3 PMID:9836481

  13. Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act.

    Science.gov (United States)

    Logvinov, Ilana

    2014-03-01

    Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Advanced divertor experiments on DIII-D

    International Nuclear Information System (INIS)

    Schaffer, M.J.; Mahdavi, M.A.; Osborne, T.; Petrie, T.W.; Stambaugh, R.D.; Buchenauer, D.; Hill, D.N.; Klepper, C.C.

    1991-01-01

    The poloidal divertor is presently favored for next-step, high-power tokamaks. The DIII-D Advanced Divertor Program (ADP) aims to gain increased control over the divertor plasma and tokamak boundary conditions. This paper reports experiments done in the first phase of the ADP. The DIII-D lower divertor was modified by the addition of a toroidally symmetric, graphite-armoured, water-cooled divertor-biasing ring electrode at the entrance to a gas plenum. (In the past DIII-D operated with an open divertor.) The plenum will eventually contain a He cryogenic loop for active divertor pumping. The separatrix 'strike' position is controlled by the lower poloidal field shaping coils and can be varied smoothly from the ring electrode upper surface to the divertor floor far from the entrance aperture. External power, at up to 550 V and 8 kA separately, has been applied to the electrode to date. (author) 5 refs., 5 figs

  15. Advances in research on 2D and 3D graphene-based supercapacitors

    Science.gov (United States)

    Mensing, Johannes Ph.; Poochai, Chatwarin; Kerdpocha, Sadanan; Sriprachuabwong, Chakrit; Wisitsoraat, Anurat; Tuantranont, Adisorn

    2017-09-01

    Graphene-based materials in two-dimensional (2D) and three-dimensional (3D) configurations are promising as electrode materials for supercapacitors due to their large surface area, excellent electrical conductivity, high electrochemical activity and high stability. In this article recent advances in research on 2D and 3D graphene-based materials for supercapacitor electrodes are reviewed extensively in aspects of fabrication methods and electrochemical performances. From the survey, the performance of 2D and 3D graphene-based materials could be significantly enhanced by employing nanostructures of metal oxides, metals and polymers as well as doping graphene with hetero atoms such as nitrogen and boron. In addition, the charge storage performances were found to depend greatly on materials, preparation method and structural configuration. With similar material components, 3D graphene-based networks tended to exhibit superior supercapacitive performances. Therefore, future research should be focusing on further development of 3D graphene-based materials for supercapacitor applications. Invited talk at 5th Thailand International Nanotechnology Conference (Nano Thailand-2016), 27-29 November 2016, Nakhon Ratchasima, Thailand.

  16. Guided Web-Based Cognitive Behavior Therapy for Perfectionism: Results From Two Different Randomized Controlled Trials.

    Science.gov (United States)

    Rozental, Alexander; Shafran, Roz; Wade, Tracey D; Kothari, Radha; Egan, Sarah J; Ekberg, Linda; Wiss, Maria; Carlbring, Per; Andersson, Gerhard

    2018-04-26

    Perfectionism can become a debilitating condition that may negatively affect functioning in multiple areas, including mental health. Prior research has indicated that internet-based cognitive behavioral therapy can be beneficial, but few studies have included follow-up data. The objective of this study was to explore the outcomes at follow-up of internet-based cognitive behavioral therapy with guided self-help, delivered as 2 separate randomized controlled trials conducted in Sweden and the United Kingdom. In total, 120 participants randomly assigned to internet-based cognitive behavioral therapy were included in both intention-to-treat and completer analyses: 78 in the Swedish trial and 62 in the UK trial. The primary outcome measure was the Frost Multidimensional Perfectionism Scale, Concern over Mistakes subscale (FMPS CM). Secondary outcome measures varied between the trials and consisted of the Clinical Perfectionism Questionnaire (CPQ; both trials), the 9-item Patient Health Questionnaire (PHQ-9; Swedish trial), the 7-item Generalized Anxiety Disorder scale (GAD-7; Swedish trial), and the 21-item Depression Anxiety Stress Scale (DASS-21; UK trial). Follow-up occurred after 6 months for the UK trial and after 12 months for the Swedish trial. Analysis of covariance revealed a significant difference between pretreatment and follow-up in both studies. Intention-to-treat within-group Cohen d effect sizes were 1.21 (Swedish trial; 95% CI 0.86-1.54) and 1.24 (UK trial; 95% CI 0.85-1.62) for the FMPS CM. Furthermore, 29 (59%; Swedish trial) and 15 (43%; UK trial) of the participants met the criteria for recovery on the FMPS CM. Improvements were also significant for the CPQ, with effect sizes of 1.32 (Swedish trial; 95% CI 0.97-1.66) and 1.49 (UK trial; 95% CI 1.09-1.88); the PHQ-9, effect size 0.60 (95% CI 0.28-0.92); the GAD-7, effect size 0.67 (95% CI 0.34-0.99); and the DASS-21, effect size 0.50 (95% CI 0.13-0.85). The results are promising for the use of

  17. Overview of recent experimental results from the DIII-D advanced tokamak program

    International Nuclear Information System (INIS)

    Allen, S.L.

    2001-01-01

    The goals of DIII-D Advanced Tokamak (AT) experiments are to investigate and optimize the upper limits of energy confinement and MHD stability in a tokamak plasma, and to simultaneously maximize the fraction of non-inductive current drive. Significant overall progress has been made in the past 2 years, as the performance figure of merit β N H 89P of 9 has been achieved in ELMing H-mode for over 16 τ E without sawteeth. We also operated at β N ∼7 for over 35 τ E or 3 τ R , with the duration limited by hardware. Real-time feedback control of β (at 95% of the stability boundary), optimizing the plasma shape (e.g., δ, divertor strike- and X-point, double/single null balance), and particle control (n e /n GW ∼0.3, Z eff N H 89P of 7. The QDB regime has been obtained to date only with counter neutral beam injection. Further modification and control of internal transport barriers (ITBs) has also been demonstrated with impurity injection (broader barrier), pellets, and ECH (strong electron barrier). The new Divertor-2000, a key ingredient in all these discharges, provides effective density, impurity and heat flux control in the high-triangularity plasma shapes. Discharges at n e /n GW ∼1.4 have been obtained with gas puffing by maintaining the edge pedestal pressure; this operation is easier with Divertor-2000. We are developing several other tools required for AT operation, including real-time feedback control of resistive wall modes (RWMs) with external coils, and control of neoclassical tearing modes (NTMs) with electron cyclotron current drive (ECCD). (author)

  18. Analysis of the influence of advanced materials for aerospace products R&D and manufacturing cost

    Science.gov (United States)

    Shen, A. W.; Guo, J. L.; Wang, Z. J.

    2015-12-01

    In this paper, we pointed out the deficiency of traditional cost estimation model about aerospace products Research & Development (R&D) and manufacturing based on analyzing the widely use of advanced materials in aviation products. Then we put up with the estimating formulas of cost factor, which representing the influences of advanced materials on the labor cost rate and manufacturing materials cost rate. The values ranges of the common advanced materials such as composite materials, titanium alloy are present in the labor and materials two aspects. Finally, we estimate the R&D and manufacturing cost of F/A-18, F/A- 22, B-1B and B-2 aircraft based on the common DAPCA IV model and the modified model proposed by this paper. The calculation results show that the calculation precision improved greatly by the proposed method which considering advanced materials. So we can know the proposed method is scientific and reasonable.

  19. NHLBI’s Program for VAD Therapy for Moderately Advanced Heart Failure: The REVIVE-IT Pilot Trial

    Science.gov (United States)

    Baldwin, J. Timothy; Mann, Douglas L.

    2010-01-01

    Background VADs are used to bridge heart failure patients to transplantation, to allow their own hearts to recover, or as permanent (“destination”) therapy. To date, the use of VADs has been limited to late-stage heart failure patients because of the associated device risks. In 2008, an NHLBI working group met to evaluate the treatment of heart failure using VADs and to advise the institute on how therapy for heart failure may be best advanced by clinical trials involving the devices. Discussion and Recommendations Recognizing the improvements in VAD technology and in patient care and selection over the past decade, the working group recommended that a trial be performed to assess the use of chronic VAD therapy in patients who are less ill than those currently eligible for destination therapy. The hypothesis proposed for the trial is that VAD therapy may improve both survival and quality of life in moderately advanced heart failure patients who are neither inotrope-dependent nor exercise-intolerant and have not yet developed serious consequences such as malnourishment, end-organ damage, and immobility. Based on the group’s recommendations, NHLBI issued an RFP in 2009 for the REVIVE-IT Pilot Trail which will serve to test the hypothesis and inform the pivotal trial. PMID:21055648

  20. [Maraviroc: clinical trials results].

    Science.gov (United States)

    Chidiac, C; Katlama, C; Yeni, P

    2008-03-01

    Just over a decade after identification of chemokine receptors CCR5 and CXCR4 as coreceptors for HIV, maraviroc (Celsentri), the first CCR5 antagonist, has recently obtained its Marketing Authorization in the United States and Europe, for treatment of treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable. CCR5 antagonists, after fusion inhibitor enfuvirtide available since 2003, also belong to entry inhibitors. These molecules, unlike previous antiretrovirals, do not target the virus but its target cell by blocking viral penetration. Maraviroc has shown its clinical efficacy in patients failing other antiretroviral classes. Its safety profile was similar to placebo in two large phase III trials. However, careful assessment of both hepatic and immunologic safety of this new therapeutic class is needed. Viral tropism testing has to be investigated before using maraviroc in the clinic, because CCR5 antagonists are not active against CXCR4 viruses. For the moment indicated for the treatment-experienced patient population, maraviroc could in the future benefit to other types of patients, depending on ongoing trials results.

  1. Vitamin D supplementation in pregnancy, prenatal 25(OH)D levels, race, and subsequent asthma or recurrent wheeze in offspring: Secondary analyses from the Vitamin D Antenatal Asthma Reduction Trial.

    Science.gov (United States)

    Wolsk, Helene M; Harshfield, Benjamin J; Laranjo, Nancy; Carey, Vincent J; O'Connor, George; Sandel, Megan; Strunk, Robert C; Bacharier, Leonard B; Zeiger, Robert S; Schatz, Michael; Hollis, Bruce W; Weiss, Scott T; Litonjua, Augusto A

    2017-11-01

    Nutrient trials differ from drug trials because participants have varying circulating levels at entry into the trial. We sought to study the effect of a vitamin D intervention in pregnancy between subjects of different races and the association between 25-hydroxyvitamin D 3 (25[OH]D) levels in pregnancy and the risk of asthma/recurrent wheeze in offspring. The Vitamin D Antenatal Asthma Reduction Trial is a randomized trial of pregnant women at risk of having children with asthma randomized to 4400 international units/d vitamin D or placebo plus 400 international units/d vitamin D. Asthma and recurrent wheezing until age 3 years were recorded. African American (AA) women (n = 312) had lower initial levels of 25(OH)D (mean [SD], 17.6 ng/mL [8.3 ng/mL]) compared with non-AA women (n = 400; 27.1 ng/mL [9.7 ng/mL], P asthma/recurrent wheezing in offspring (P for interaction = .77). Having an initial level of greater than 30 ng/mL and being randomized to the intervention group was associated with the lowest risk for asthma/recurrent wheeze by age 3 years compared with having an initial level of less than 20 ng/mL and receiving placebo (adjusted odds ratio, 0.42; 95% CI, 0.19-0.91). We did not find differences between AA and non-AA mothers in the effect of maternal vitamin D supplementation and asthma/recurrent wheeze in offspring at 3 years. Maternal supplementation of vitamin D, particularly in mothers with initial 25(OH)D levels of greater than 30 ng/mL, reduced asthma/recurrent wheeze in the offspring through age 3 years, suggesting that higher vitamin D status beginning in early pregnancy is necessary for asthma/recurrent wheeze prevention in early life. Copyright © 2017 American Academy of Allergy, Asthma & Immunology. All rights reserved.

  2. A phase I/II trial of beta-(1,3/(1,6 D-glucan in the treatment of patients with advanced malignancies receiving chemotherapy

    Directory of Open Access Journals (Sweden)

    Weitberg Alan B

    2008-09-01

    Full Text Available Abstract β-(1,3/(1,6 D-glucan, a component of the fungal cell wall, has been shown to stimulate the immune system, enhance hematopoiesis, amplify killing of opsonized tumor cells and increase neutrophil chemotaxis and adhesion. In view of these attributes, the β-glucans should be studied for both their therapeutic efficacy in patients with cancer as well as an adjunctive therapy in patients receiving chemotherapy as a maneuver to limit suppression of hematopoiesis. In this study, twenty patients with advanced malignancies receiving chemotherapy were given a β-(1,3/(1,6 D-glucan preparation (MacroForce plus IP6, ImmuDyne, Inc. and monitored for tolerability and effect on hematopoiesis. Our results lead us to conclude that β-glucan is well-tolerated in cancer patients receiving chemotherapy, may have a beneficial effect on hematopoiesis in these patients and should be studied further, especially in patients with chronic lymphocytic leukemia and lymphoma.

  3. 48 CFR 252.232-7005 - Reimbursement of subcontractor advance payments-DoD pilot mentor-protege program.

    Science.gov (United States)

    2010-10-01

    ... subcontractor advance payments-DoD pilot mentor-protege program. 252.232-7005 Section 252.232-7005 Federal... subcontractor advance payments—DoD pilot mentor-protege program. As prescribed in 232.412-70(c), use the following clause: Reimbursement of Subcontractor Advance Payments—DoD Pilot Mentor-Protege Program (SEP 2001...

  4. Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial.

    Science.gov (United States)

    Thacher, Tom D; Fischer, Philip R; Pettifor, John M

    2014-09-01

    To determine whether children with calcium-deficiency rickets have a better response to treatment with vitamin D and calcium than with calcium alone. Randomised controlled trial. Jos University Teaching Hospital, Jos, Nigeria. Nigerian children with active rickets treated with calcium carbonate as limestone (approximately 938 mg elemental calcium twice daily) were, in addition, randomised to receive either oral vitamin D2 50,000 IU (Ca+D, n=44) or placebo (Ca, n=28) monthly for 24 weeks. Achievement of a 10-point radiographic severity score ≤1.5 and serum alkaline phosphatase ≤350 U/L. The median (range) age of enrolled children was 46 (15-102) months, and baseline characteristics were similar in the two groups. Mean (±SD) 25-hydroxyvitamin D (25(OH)D) was 30.2±13.2 nmol/L at baseline, and 29 (43%) had values rickets, there is a trend for vitamin D to improve the response to treatment with calcium carbonate as limestone, independent of baseline 25(OH)D concentrations. ClinicalTrials.gov NCT00949832. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  5. FY2016 Advanced Batteries R&D Annual Progress Report

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    2017-08-31

    The Advanced Batteries research and development (R&D) subprogram within the DOE Vehicle Technologies Office (VTO) provides support and guidance for projects focusing on batteries for plug-in electric vehicles. Program targets focus on overcoming technical barriers to enable market success including: (1) significantly reducing battery cost, (2) increasing battery performance (power, energy, durability), (3) reducing battery weight & volume, and (4) increasing battery tolerance to abusive conditions such as short circuit, overcharge, and crush. This report describes the progress made on the research and development projects funded by the Battery subprogram in 2016. This section covers the Vehicle Technologies Office overview; the Battery subprogram R&D overview; Advanced Battery Development project summaries; and Battery Testing, Analysis, and Design project summaries. It also includes the cover and table of contents.

  6. Multi-dose vitamin d supplementation in stable very preterm infants: Prospective randomized trial response to three different vitamin D supplementation doses.

    Science.gov (United States)

    Bozkurt, Ozlem; Uras, Nurdan; Sari, Fatma Nur; Atay, Funda Yavanoglu; Sahin, Suzan; Alkan, Ayse Dogan; Canpolat, Fuat Emre; Oguz, Serife Suna

    2017-09-01

    Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is recommended there is no consensus regarding the adequate dose of supplementation for preterm infants. To assess the effect of three different doses of vitamin D supplementation (400, 800 and 1000IU/d) in preterm infants ≤32weeks gestation on the prevalence of vitamin D deficiency and 25(OH) D levels at 36weeks postmenstrual age (PMA). Prospective randomized trial. 121 preterm infants with gestational age of 24-32weeks were randomly allocated to receive 400, 800 or 1000IU/d vitamin D. Serum concentration of 25(OH) D and the prevalence of vitamin D deficiency at 36weeks PMA. Vitamin D deficiency was defined as serum 25(OH) D concentrations vitamin D levels before supplementation. The average 25(OH) vitamin D concentrations at 36weeks PMA were significantly higher in 800IU (40±21.4ng/ml) and 1000IU group (43±18.9ng/ml) when compared to 400IU group (29.4±13ng/ml). The prevalence of vitamin D deficiency (2.5 vs 22.5; RR: 0.09; CI:0.01-0.74) and insufficiency (30 vs 57.5; RR:0.32; CI:0.13-0.80) was significantly lower in 1000IU group when compared to 400IU group at 36weeks PMA. 1000IU/d of vitamin D supplementation in preterm infants ≤32weeks gestation age effectively decreases the prevalence of vitamin D deficiency and leads to higher concentrations of 25(OH) vitamin D at 36weeks PMA TRIAL REGISTRATION: Clinical Trials.gov: NCT02941185. Copyright © 2017. Published by Elsevier B.V.

  7. Evaluation of the trial design studies for an advanced marine reactor, (3)

    International Nuclear Information System (INIS)

    Ambo, Noriaki; Yokomura, Takeyoshi.

    1988-03-01

    JAERI have carried out four core designs for three different type reactors (Semi-Integrated, Integrated and Integrated (self-pressured) type reactors), as the trial designs of an Advanced Marine Reactor for three years (1983 ∼ 1985). This report describes the result of comparison and studies of the core specific characteristics of these four cores, which include core concept, specifications, core life, specific power density, burn-up, reactivity control and etc. In conclusion, it was found that the Integrated type reactor core and the Semi-Integrated type reactor core designs satisfy the conditions of long core life (four years), high specific power density (50 ∼ 61 kw/l) and high burn-up (30,000 ∼ 32,000 MWD/t), so these two cores will be optimum designs based on the present technologies. (author)

  8. Engineering, installation, testing, and initial operation of the DIII-D Advanced Divertor

    International Nuclear Information System (INIS)

    Andersen, P.M.; Baxi, C.B.; Reis, E.E.; Schaffer, M.J.; Smith, J.P.

    1990-09-01

    The Advanced Divertor (AD) for General Atomics tokamak, DIII-D, was installed in the summer of 1990. The AD has enabled two classes of physics experiments to be run: divertor biasing and divertor baffling. Both are new experiments for DIII-D. The AD has two principal components: (1) a continuous ring electrode; and (2) a toroidally symmetric baffle. The tokamak can be run in bias baffle or standard DIII-D divertor modes by accurate positioning of the outer divertor strike point through the use of the DIII-D control system. The paper covers design, analysis, fabrication, installation, instrumentation, testing, initial operation, and future plans for the Advanced Divertor from an engineering viewpoint. 2 refs., 5 figs

  9. Advances in Integrated Plasma Control on DIII-D

    International Nuclear Information System (INIS)

    Walker, M.L.; Ferron, J.R.; Humphreys, D.A.

    2006-01-01

    The DIII-D experimental program in advanced tokamak (AT) physics requires extremely high performance from the DIII-D plasma control system (PCS) [B.G.Penaflor, et al., 4 th IAEA Tech. Mtg on Control and Data Acq., San Diego, CA (2003)], including simultaneous and highly accurate regulation of plasma shape, stored energy, density, and divertor characteristics, as well as coordinated suppression of magnetohydrodynamic instabilities. To satisfy these demanding control requirements, we apply the integrated plasma control method, consisting of construction of physics-based plasma and system response models, validation of models against operating experiments, design of integrated controllers that operate in concert with one another as well as with supervisory modules, simulation of control action against off-line and actual machine control platforms, and optimization through iteration of the design-test loop. The present work describes progress in development of physics models and development and experimental application of several new model-based plasma controllers on DIII-D. We discuss experimental use of advanced shape control algorithms containing nonlinear techniques for improving control of steady state plasmas, model-based controllers for optimal rejection of edge localized mode disturbances during resistive wall mode stabilization, model-based controllers for neoclassical tearing mode stabilization, including methods for maximizing stabilization effectiveness with substantial constraints on available power, model-based integrated control of plasma rotation and beta, and initial experience in development of model-based controllers for advanced tokamak current profile modification. The experience gained from DIII-D has been applied to the development of control systems for the EAST and KSTAR tokamaks. We describe the development of the control software, hardware, and model-based control algorithms for these superconducting tokamaks, with emphasis on relevance of

  10. Advanced divertor experiments on DIII-D

    International Nuclear Information System (INIS)

    Schaffer, M.J.; Mahdavi, M.A.; Osborne, T.; Petrie, T.W.; Stambaugh, R.D.; Buchenauer, D.; Hill, D.N.; Klepper, C.C.

    1991-04-01

    The poloidal divertor is presently favored for next-step, high-power tokamaks. The DIII-D Advanced Divertor Program (ADP) aims to gain increased control over the divertor plasma and tokamak boundary conditions. This paper reports experiments done in the first phase of the ADP. The DIII-D lower divertor was modified by the addition of a toroidally symmetric, graphite-armoured, water-cooled divertor-biasing ring electrode at the entrance to a gas plenum. The plenum will eventually contain a He cryogenic loop for active divertor pumping. The separatrix ''strike'' position is controlled by the lower poloidal field shaping coils and can be varied smoothly from the ring electrode upper surface to the divertor floor far from the entrance aperture. External power, at up to 550 V and 8 kA separately, has been applied to the electrode to date. 5 refs., 5 figs

  11. Recent Treatment Advances and New Trials in Adult Nephrotic Syndrome

    Directory of Open Access Journals (Sweden)

    Eva Königshausen

    2017-01-01

    Full Text Available The etiology of nephrotic syndrome is complex and ranges from primary glomerulonephritis to secondary forms. Patients with nephrotic syndrome often need immunosuppressive treatment with its side effects and may progress to end stage renal disease. This review focuses on recent advances in the treatment of primary causes of nephrotic syndrome (idiopathic membranous nephropathy (iMN, minimal change disease (MCD, and focal segmental glomerulosclerosis (FSGS since the publication of the KDIGO guidelines in 2012. Current treatment recommendations are mostly based on randomized controlled trials (RCTs in children, small RCTs, or case series in adults. Recently, only a few new RCTs have been published, such as the Gemritux trial evaluating rituximab treatment versus supportive antiproteinuric and antihypertensive therapy in iMN. Many RCTs are ongoing for iMN, MCD, and FSGS that will provide further information on the effectiveness of different treatment options for the causative disease. In addition to reviewing recent clinical studies, we provide insight into potential new targets for the treatment of nephrotic syndrome from recent basic science publications.

  12. A randomized controlled trial of vitamin D supplementation on perinatal depression: in Iranian pregnant mothers

    OpenAIRE

    Vaziri, Farideh; Nasiri, Samira; Tavana, Zohreh; Dabbaghmanesh, Mohammad Hossein; Sharif, Farkhondeh; Jafari, Peyman

    2016-01-01

    Background Mood disorders in pregnancy and post-partum period are common and considered as a public health issue. Researchers have studied the relationship between low serum vitamin D concentration and perinatal depression, although no clinical trial has been conducted on vitamin D?s effects on depression related to childbirth. This study evaluated the effect of vitamin D3 supplementation on perinatal depression scores. Methods This randomized clinical trial was done in pregnant women who wer...

  13. PEGylated carboxyhemoglobin bovine (SANGUINATE): results of a phase I clinical trial.

    Science.gov (United States)

    Misra, Hemant; Lickliter, Jason; Kazo, Friedericke; Abuchowski, Abraham

    2014-08-01

    PEGylated carboxyhemoglobin bovine (SANGUINATE) is a dual action carbon monoxide releasing (CO)/oxygen (O2 ) transfer agent for the treatment of hypoxia. Its components inhibit vasoconstriction, decrease extravasation, limit reactive oxygen species production, enhance blood rheology, and deliver oxygen to the tissues. Animal models of cerebral ischemia, peripheral ischemia, and myocardial ischemia demonstrated SANGUINATE's efficacy in reducing myocardial infarct size, limiting necrosis from cerebral ischemia, and promoting more rapid recovery from hind limb ischemia. In a Phase I trial, three cohorts of eight healthy volunteers received single ascending doses of 80, 120, or 160 mg/kg of SANGUINATE. Two volunteers within each cohort served as a saline control. There were no serious adverse events. Serum haptoglobin decreased, but did not appear to be dose related. The T1/2 was dose dependent and ranged from 7.9 to 13.8 h. In addition to the Phase I trial, SANGUINATE was used under an expanded access emergency Investigational New Drug. SANGUINATE was found to be safe and well tolerated in a Phase I clinical trial, and therefore it will advance into further clinical trials in patients. © 2014 The Authors. Artificial Organs published by Wiley Periodicals, Inc. on behalf of International Center for Artificial Organs and Transplantation (ICAOT).

  14. Radiotherapy with or without hyperthermia in the treatment of superficial localized breast cancer: results from five randomized controlled trials

    International Nuclear Information System (INIS)

    Vernon, Clare C.; Hand, Jeffrey W.; Field, Stanley B.; Machin, David; Whaley, Jill B.; Zee, Jacoba van der; Putten, Wim L.J. van; Rhoon, Gerard C. van; Dijk, Jan D.P. van; Gonzalez, Dionisio Gonzalez; Liu, F.-F.; Goodman, Phyllis; Sherar, Michael

    1996-01-01

    Purpose: Claims for the value of hyperthermia as an adjunct to radiotherapy in the treatment of cancer have mostly been based on small Phase I or II trials. To test the benefit of this form of treatment, randomized Phase III trials were needed. Methods and Materials: Five randomized trials addressing this question were started between 1988 and 1991. In these trials, patients were eligible if they had advanced primary or recurrent breast cancer, and local radiotherapy was indicated in preference to surgery. In addition, heating of the lesions and treatment with a prescribed (re)irradiation schedule had to be feasible and informed consent was obtained. The primary endpoint of all trials was local complete response. Slow recruitment led to a decision to collaborate and combine the trial results in one analysis, and report them simultaneously in one publication. Interim analyses were carried out and the trials were closed to recruitment when a previously agreed statistically significant difference in complete response rate was observed in the two larger trials. Results: We report on pretreatment characteristics, the treatments received, the local response observed, duration of response, time to local failure, distant progression and survival, and treatment toxicity of the 306 patients randomized. The overall CR rate for RT alone was 41% and for the combined treatment arm was 59%, giving, after stratification by trial, an odds ratio of 2.3. Not all trials demonstrated an advantage for the combined treatment, although the 95% confidence intervals of the different trials all contain the pooled odds ratio. The greatest effect was observed in patients with recurrent lesions in previously irradiated areas, where further irradiation was limited to low doses. Conclusion: The combined result of the five trials has demonstrated the efficacy of hyperthermia as an adjunct to radiotherapy for treatment of recurrent breast cancer. The implication of these encouraging results is that

  15. Abnormal P-53 suppressor gene expression predicts for a poorer outcome in patients with locally advanced adenocarcinoma of the prostate treated by external beam radiation therapy with or without pre-radiation androgen ablation: results based on RTOG study 86-10

    International Nuclear Information System (INIS)

    Lawton, Colleen A.; Grignon, David; Caplan, Richard; Sarkar, Fazlul; Forman, Jeffrey; Mesic, John; Fu, Karen K.; Abrams, Ross

    1995-01-01

    Purpose/Objective: The purpose of this study is to establish the effect of the abnormal expression of the P-53 suppressor gene on the results of locally advanced adenocarcinoma of the prostate treated with radiation therapy with or without pre-radiation therapy androgen ablation. Materials and Methods: Patients evaluated were part of a RTOG phase III multi-institutional trial. This trial assessed the value of pre-radiation therapy androgen ablation on patients with locally advanced disease (bulky stage B and stage C). Of the 471 patients registered, pre-treatment pathological material was available for 129 patients. P-53 status was determined immunohistochemically utilizing a commercially available antibody (D07). Clinical endpoints evaluated were overall survival and development of metastases. Results: Twenty-three of the 129 patients had abnormal expression of the P-53 suppressor gene. Presence of this abnormal expression significantly correlated with lower overall survival (p=0.03) and the development of distant metastases (p=0.03). Abnormal expression of the P-53 gene was an independent prognostic indicator when evaluated against clinical stage and Gleason score. Conclusion: This data from patients entered on a phase III multi-institutional, randomized clinical trial shows that abnormal P-53 suppressor gene expression as determined immunohistochemically is an independent predictor of poorer survival and the development of distant metastases in patients with locally advanced adenocarcinoma of the prostate treated with radiation therapy with or without pre-radiation therapy androgen ablation

  16. Randomized controlled trial using vitamins E and D supplementation in atopic dermatitis.

    Science.gov (United States)

    Javanbakht, Mohammad Hassan; Keshavarz, Seyed Ali; Djalali, Mahmoud; Siassi, Fereydoun; Eshraghian, Mohammad Reza; Firooz, Alireza; Seirafi, Hassan; Ehsani, Amir Hooshang; Chamari, Maryam; Mirshafiey, Abbas

    2011-06-01

    Atopic dermatitis is a chronically relapsing, highly pruritic and inflammatory skin disease. This study was done to assess the effects of vitamins D and E supplementation on the clinical manifestation of atopic dermatitis. Forty-five atopic dermatitis patients were included in a randomized, double-blind, placebo-controlled trial. They were randomly divided into four groups and treated for 60 days: group P (n = 11), vitamins D and E placebos; group D (n = 12), 1600 IU vitamin D(3) plus vitamin E placebo; group E (n = 11), 600 IU synthetic all-rac-α-tocopherol plus vitamin D placebo; and group DE (n = 11), 1600 IU vitamin D(3) plus 600 IU synthetic all-rac-α-tocopherol. Serum 25(OH) vitamin D and plasma α-tocopherol were determined before and after the trial. The clinical improvement was evaluated with SCORing Atopic Dermatitis (SCORAD). Data were analyzed by analysis of variance (ANOVA) and Kruskal-Wallis tests. SCORAD was reduced after 60 days in groups D, E and DE by 34.8%, 35.7% and 64.3%, respectively (p = 0.004). Objective SCORAD also showed significant improvement. There was a positive correlation between SCORAD and intensity, objective, subjective and extent (p vitamins D and E in the treatment of atopic dermatitis.

  17. Field Trial of LANL On-Line Advanced Enrichment Monitor for UF6 GCEP

    Energy Technology Data Exchange (ETDEWEB)

    Ianakiev, Kiril D. [Los Alamos National Laboratory; Lombardi, Marcie [Los Alamos National Laboratory; MacArthur, Duncan W. [Los Alamos National Laboratory; Parker, Robert F. [Los Alamos National Laboratory; Smith, Morag K. [Los Alamos National Laboratory; Keller, Clifford [Los Alamos National Laboratory; Friend, Peter [URENCO; Dunford, Andrew [URENCO

    2012-07-13

    The outline of this presentation is: (1) Technology basis of on-line enrichment monitoring; (2) Timescale of trial; (3) Description of installed equipment; (4) Photographs; (5) Results; (6) Possible further development; and (7) Conclusions. Summary of the good things about the Advanced Enrichment Monitor (AEM) performance is: (1) High accuracy - normally better than 1% relative, (2) Active system as accurate as passive system, (3) Fast and accurate detection of enrichment changes, (4) Physics is well understood, (5) Elegant method for capturing pressure signal, and (6) Data capture is automatic, low cost and fast. A couple of negative things are: (1) Some jumps in measured passive enrichment - of around +2% relative (due to clock errors?); and (2) Data handling and evaluation is off-line, expensive and very slow. Conclusions are: (1) LANL AEM is being tested on E23 plant at Capenhurst; (2) The trial is going very well; (3) AEM could detect production of HEU at potentially much lower cost than existing CEMO; (4) AEM can measure {sup 235}U assay accurately; (5) Active system using X-Ray source would avoid need for pressure measurement; (6) Substantial work lies ahead to go from current prototype to a production instrument.

  18. Weekly oxaliplatin, 5-fluorouracil and folinic acid (OXALF as first-line chemotherapy for elderly patients with advanced gastric cancer: results of a phase II trial

    Directory of Open Access Journals (Sweden)

    Vincenzi B

    2006-05-01

    Full Text Available Abstract Background Elderly patients have been often excluded from or underrepresented in the study populations of combination chemotherapy trials. The primary end point of this study was to determine the response rate and the toxicity of the weekly oxaliplatin, 5-fluorouracil and folinic acid (OXALF regimen in elderly patients with advanced gastric cancer. The secondary objective was to measure the time to disease progression and the survival time. Methods Chemotherapy-naive patients with advanced gastric cancer aged 70 or older were considered eligible for study entry. Patients received weekly oxaliplatin 40 mg/m2, fluorouracil 500 mg/m2 and folinic acid 250 mg/m2. All drugs were given intravenously on a day-1 schedule. Results A total of 42 elderly patients were enrolled. Median age was 73 years and all patients had metastatic disease. The response rate according to RECIST criteria was 45.2% (95% CIs: 30%–56% with two complete responses, 17 partial responses, 13 stable diseases and 10 progressions, for an overall tumor rate control of 76.2% (32 patients. Toxicity was generally mild and only three patients discontinued treatment because of treatment related adverse events. The most common treatment-related grade 3/4 adverse events were fatigue (7.1%, diarrhoea (4.8%, mucositis (2.4%, neurotoxicity (2.4% and neutropenia (4.8%. The median response duration was 5.3 months (95% CIs: 2.13 – 7.34, the median time to disease progression was 5.0 months (95% CIs: 3.75 – 6.25 and the median survival time was 9.0 months (95% CIs: 6.18 – 11.82. Conclusion OXALF represents an active and well-tolerated treatment modality for elderly patients with locally advanced and metastatic gastric cancer.

  19. Default options in advance directives: study protocol for a randomised clinical trial

    Science.gov (United States)

    Gabler, Nicole B; Cooney, Elizabeth; Small, Dylan S; Troxel, Andrea B; Arnold, Robert M; White, Douglas B; Angus, Derek C; Loewenstein, George; Volpp, Kevin G; Bryce, Cindy L; Halpern, Scott D

    2016-01-01

    Introduction Although most seriously ill Americans wish to avoid burdensome and aggressive care at the end of life, such care is often provided unless patients or family members specifically request otherwise. Advance directives (ADs) were created to provide opportunities to set limits on aggressive care near life's end. This study tests the hypothesis that redesigning ADs such that comfort-oriented care is provided as the default, rather than requiring patients to actively choose it, will promote better patient-centred outcomes. Methods and analysis This multicentre trial randomises seriously ill adults to receive 1 of 3 different ADs: (1) a traditional AD that requires patients to actively choose their goals of care or preferences for specific interventions (eg, feeding tube insertion) or otherwise have their care guided by their surrogates and the prevailing societal default toward aggressive care; (2) an AD that defaults to life-extending care and receipt of life-sustaining interventions, enabling patients to opt out from such care; or (3) an AD that defaults to comfort care, enabling patients to opt into life-extending care. We seek to enrol 270 patients who return complete, legally valid ADs so as to generate sufficient power to detect differences in the primary outcome of hospital-free days (days alive and not in an acute care facility). Secondary outcomes include hospital and intensive care unit admissions, costs of care, hospice usage, decision conflict and satisfaction, quality of life, concordance of preferences with care received and bereavement outcomes for surrogates of patients who die. Ethics and dissemination This study has been approved by the Institutional Review Boards at all trial centres, and is guided by a data safety and monitoring board and an ethics advisory board. Study results will be disseminated using methods that describe the results in ways that key stakeholders can best understand and implement. Trial registration number NCT02017548

  20. Transparency in ovarian cancer clinical trial results: ClinicalTrials.gov versus PubMed, Embase and Google scholar.

    Science.gov (United States)

    Roberto, Anna; Radrezza, Silvia; Mosconi, Paola

    2018-04-10

    In recent years the question of the lack of transparency in clinical research has been debated by clinicians, researchers, citizens and their representatives, authors and publishers. This is particularly important for infrequent cancers such as ovarian cancer, where treatment still gives disappointing results in the majority of cases. Our aim was to assess the availability to the public of results in ClinicalTrials.gov, and the frequency of non-publication of results in ClinicalTrials.gov and in PubMed, Embase and Google Scholar. We collected all trials on ovarian cancer identified as "completed status" in the ClinicalTrials.gov registry on 17 January 2017. We checked the availability of the results in ClinicalTrials.gov and systematically identified published manuscripts on results. Out of 2725 trials on ovarian cancer identified, 752 were classified as "completed status". In those closed between 2008 and 2015, excluding phase I, the frequency of results in ClinicalTrials.gov was 35%. Of the 752 completed studies the frequency of published results in PubMed, Embase or Google Scholar ranged from 57.9% to 69.7% in the last years. These findings show a lack of transparency and credibility of research. Citizens or patients' representatives, with the medical community, should continuously support initiatives to improve the publication and dissemination of clinical study results.

  1. Recombinant factor VIIa for variceal bleeding in patients with advanced cirrhosis: A randomized, controlled trial

    DEFF Research Database (Denmark)

    Bosch, Jaime; Thabut, Dominique; Albillos, Agustín

    2008-01-01

    A beneficial effect of recombinant activated factor VII (rFVIIa) in Child-Pugh class B and C patients with cirrhosis who have variceal bleeding has been suggested. This randomized controlled trial assessed the efficacy and safety of rFVIIa in patients with advanced cirrhosis and active variceal...

  2. Vitamin D for the Treatment of Epilepsy: Basic Mechanisms, Animal Models and Clinical Trials

    Directory of Open Access Journals (Sweden)

    Kevin Pendo

    2016-12-01

    Full Text Available There is increasing evidence supporting dietary and alternative therapies for epilepsy, including the ketogenic diet, modified Atkins diet, and omega-3 fatty acids. Vitamin D is actively under investigation as a potential intervention for epilepsy. Vitamin D is fat soluble steroid which shows promise in animal models of epilepsy. Basic research has shed light on the possible mechanisms by which Vitamin D may reduce seizures, and animal data support the efficacy of Vitamin D in rat and mouse models of epilepsy. Very little clinical data exists to support the treatment of human epilepsy with Vitamin D, but positive findings from preliminary clinical trials warrant larger Phase I and II clinical trials in order to more rigorously determine the potential therapeutic value of Vitamin D as a treatment for human epilepsy.

  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. Report on 1982 research result on the R and D of environmental resistance reinforcing element; 1982 nendo taikankyo kyoka soshi no kenkyu kaihatsu

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1983-03-01

    This research was intended to establish technology for the substrate of an environmental resistance reinforcing element in which environmental resistance was enhanced against radiation, heat, mechanical shock, etc., for the purpose of realizing various kinds of equipment and devices for performing advanced information processing under severe environmental conditions of outer space, nuclear reactors, travelling objects such as automobiles and aircrafts, and plants. In the R and D of the technology of a MOS type silicon integrated circuit element, a technological improvement was conducted for the trial element of 1981 and the basic circuit structure. In the actual mounting technology, a radiation test for example was performed on a trial basic gate mounted on a package. with malfunction analysis started. In the R and D of the technology of a bipolar type silicon integrated circuit element, a preliminary investigation was carried out on the radiation resistance properties of the package materials, with basic data obtained for the evaluation test. In the R and D of the technology for a compound semiconductor integrated circuit element, development was performed for the element structure, which reinforced the radiation resistance of the basic integrated circuit element developed in 1981, as well as for its manufacturing technology. In the actual mounting technology, an environmental resistance test began for the basic integrated circuit of the 1981 trial production. (NEDO)

  5. Effects of Vitamin D Supplementation on Bone Turnover Markers: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Verena Schwetz

    2017-04-01

    Full Text Available Bone turnover markers (BTMs are used to evaluate bone health together with bone mineral density and fracture assessment. Vitamin D supplementation is widely used to prevent and treat musculoskeletal diseases but existing data on vitamin D effects on markers of bone resorption and formation are inconsistent. We therefore examined the effects of vitamin D supplementation on bone-specific alkaline phosphatase (bALP, osteocalcin (OC, C-terminal telopeptide (CTX, and procollagen type 1 N-terminal propeptide (P1NP. This is a post-hoc analysis of the Styrian Vitamin D Hypertension Trial, a single-center, double-blind, randomized, placebo-controlled trial (RCT performed at the Medical University of Graz, Austria (2011–2014. Two hundred individuals with arterial hypertension and 25-hydroxyvitamin D (25[OH]D levels <75 nmol/L were randomized to 2800 IU of vitamin D daily or placebo for eight weeks. One hundred ninety-seven participants (60.2 ± 11.1 years; 47% women were included in this analysis. Vitamin D had no significant effect on bALP (mean treatment effect (MTE 0.013, 95% CI −0.029 to 0.056 µg/L; p = 0.533, CTX (MTE 0.024, 95% CI −0.163 to 0.210 ng/mL, p = 0.802, OC (MTE 0.020, 95% CI −0.062 to 0.103 ng/mL, p = 0.626, or P1NP (MTE −0.021, 95% CI −0.099 to 0.057 ng/mL, p = 0.597. Analyzing patients with 25(OHD levels <50 nmol/L separately (n = 74 left results largely unchanged. In hypertensive patients with low 25(OHD levels, we observed no significant effect of vitamin D supplementation for eight weeks on BTMs.

  6. Analysis of the influence of advanced materials for aerospace products R and D and manufacturing cost

    International Nuclear Information System (INIS)

    Shen, A W; Guo, J L; Wang, Z J

    2015-01-01

    In this paper, we pointed out the deficiency of traditional cost estimation model about aerospace products Research and Development (R and D) and manufacturing based on analyzing the widely use of advanced materials in aviation products. Then we put up with the estimating formulas of cost factor, which representing the influences of advanced materials on the labor cost rate and manufacturing materials cost rate. The values ranges of the common advanced materials such as composite materials, titanium alloy are present in the labor and materials two aspects. Finally, we estimate the R and D and manufacturing cost of F/A-18, F/A- 22, B-1B and B-2 aircraft based on the common DAPCA IV model and the modified model proposed by this paper. The calculation results show that the calculation precision improved greatly by the proposed method which considering advanced materials. So we can know the proposed method is scientific and reasonable. (paper)

  7. Advanced Cardiac Resuscitation Evaluation (ACRE: A randomised single-blind controlled trial of peer-led vs. expert-led advanced resuscitation training

    Directory of Open Access Journals (Sweden)

    Hughes Thomas C

    2010-01-01

    Full Text Available Abstract Background Advanced resuscitation skills training is an important and enjoyable part of medical training, but requires small group instruction to ensure active participation of all students. Increases in student numbers have made this increasingly difficult to achieve. Methods A single-blind randomised controlled trial of peer-led vs. expert-led resuscitation training was performed using a group of sixth-year medical students as peer instructors. The expert instructors were a senior and a middle grade doctor, and a nurse who is an Advanced Life Support (ALS Instructor. A power calculation showed that the trial would have a greater than 90% chance of rejecting the null hypothesis (that expert-led groups performed 20% better than peer-led groups if that were the true situation. Secondary outcome measures were the proportion of High Pass grades in each groups and safety incidents. The peer instructors designed and delivered their own course material. To ensure safety, the peer-led groups used modified defibrillators that could deliver only low-energy shocks. Blinded assessment was conducted using an Objective Structured Clinical Examination (OSCE. The checklist items were based on International Liaison Committee on Resuscitation (ILCOR guidelines using Ebel standard-setting methods that emphasised patient and staff safety and clinical effectiveness. The results were analysed using Exact methods, chi-squared and t-test. Results A total of 132 students were randomised: 58 into the expert-led group, 74 into the peer-led group. 57/58 (98% of students from the expert-led group achieved a Pass compared to 72/74 (97% from the peer-led group: Exact statistics confirmed that it was very unlikely (p = 0.0001 that the expert-led group was 20% better than the peer-led group. There were no safety incidents, and High Pass grades were achieved by 64 (49% of students: 33/58 (57% from the expert-led group, 31/74 (42% from the peer-led group. Exact

  8. Effect of 3D radiotherapy planning compared to 2D planning within a conventional treatment schedule of advanced lung cancer

    International Nuclear Information System (INIS)

    Schraube, P.; Spahn, U.; Oetzel, D.; Wannenmacher, M.

    2000-01-01

    Background: The effect of 3D radiotherapy planning (3D RTP) in comparison to 2D radiotherapy planning (2D RTP) was evaluated in a usually practiced treatment schedule (starting by v./d. opposing portals, continued with computer-planned portals) for non-small-cell lung cancer. Patients and Methods: In 20 patients with locally advanced non-small-cell lung cancer the computer-planned part of the treatment schedule was calculated 2- and 3-dimensionally. Target volume were the primary tumor, the involved and the electively irradiated mediastinal lymph nodes. The results of the 2D RTP were recalculated 3-dimensionally and the mean doses to target volume and organs at risk were defined. Further, the normal tissue complications were calculated. Results: Under the prerequisite of 44 Gy maximally allowed to the spinal cord and a dose to the reference point of 50 Gy a small, but significant advantage with 2.1 Gy to the target (p=0.004) and a reduction of 3.6 Gy to the heart (p=0.05) was achievable for 3D RTP. The dose to the lungs did not differ significantly (19.7 Gy for 2D RTP, 20.3 Gy for 3D RTP). The dose to the heart was not estimated critical by NTCP (normal tissue complication probability). The NTCP for the ipsilateral lung was 16.1 and 18.7% for 2D RTP and 3D RTP, respectively. Regarding the simulator-planned ap/pa fields at the start of the radiotherapy the advantage of 3D RTP was further reduced but remained significant. Favorable with respect to the mean lung dose and the NTCP (18.7% NTCP ipsilateral lung for early onset of 3D planned radiotherapy vs 31.7% for late onset of 3D planned radiotherapy) but not significantly measurable is the early start of the treatment by computerized RTP. Conclusion: The main advantage of 3D RTP in treatment of advanced lung cancer is the better coverage of the target volume. A reduction of the mean lung dose cannot be expected. A dose escalation by 3D RTP to target volumes as described here seems not to be possible because of

  9. [Advanced accelerator R and D program]. Final report

    International Nuclear Information System (INIS)

    1997-01-01

    This proposal requests funding for a 3-year renewal of the DOE advanced accelerator R and D (AARD) program at Texas A and M University. The program to date has focused on the development of the gigatron, a compact high-efficiency microwave driver for future linear colliders. The author reports results and progress in that project, and plans to bring it to a milestone and conclusion by mid-1995. He proposes to initiate a second project, the development of a new technology for ultra-high field superconducting magnets for future hadron colliders. This project builds upon two magnet designs which he has introduced during the past year, which have the potential for a dramatic extension of the achievable field strength for both dipoles and quadrupoles

  10. Vitamin D supplementation has no effect on insulin sensitivity or secretion in vitamin D-deficient, overweight or obese adults: a randomized placebo-controlled trial.

    Science.gov (United States)

    Mousa, Aya; Naderpoor, Negar; de Courten, Maximilian Pj; Teede, Helena; Kellow, Nicole; Walker, Karen; Scragg, Robert; de Courten, Barbora

    2017-06-01

    Background: Vitamin D supplementation has been proposed as a potential strategy to prevent type 2 diabetes. Existing clinical trials have been limited by short duration, low doses of vitamin D, variability in participants' vitamin D-deficiency status, and the use of surrogate measures of body composition, insulin sensitivity, and insulin secretion. Objective: To address existing knowledge gaps, we conducted a double-blind, randomized, placebo-controlled trial to investigate whether vitamin D supplementation that is provided in a sufficient dose and duration to vitamin D-deficient individuals would improve insulin sensitivity or secretion as measured with the use of gold-standard methods. We hypothesized that vitamin D supplementation would improve insulin sensitivity and secretion compared with placebo. Design: Sixty-five overweight or obese, vitamin D-deficient (25-hydroxyvitamin D [25(OH)D] concentration ≤50 nmol/L) adults were randomly assigned to receive either a bolus oral dose of 100,000 IU cholecalciferol followed by 4000 IU cholecalciferol/d or a matching placebo for 16 wk. Before and after the intervention, participants received gold-standard assessments of body composition (via dual X-ray absorptiometry), insulin sensitivity (via hyperinsulinemic-euglycemic clamps), and insulin secretion [via intravenous-glucose-tolerance tests (IVGTTs)]. Results: Fifty-four participants completed the study [35 men and 19 women; mean ± SD age: 31.9 ± 8.5 y; body mass index (in kg/m 2 ): 30.9 ± 4.4]. 25(OH)D increased with vitamin D supplementation compared with placebo (57.0 ± 21.3 compared with 1.9 ± 15.1 nmol/L, respectively; P = 0.02). Vitamin D and placebo groups did not differ in change in insulin sensitivity (0.02 ± 2.0 compared with -0.03 ± 2.8 mg · kg -1 · min -1 , respectively; P = 0.9) or first-phase insulin secretion (-21 ± 212 compared with 24 ± 184 mU/L, respectively; P = 0.9). Results remained nonsignificant after adjustment for age, sex

  11. Decade of PV Industry R and D Advances in Silicon Module Manufacturing

    Energy Technology Data Exchange (ETDEWEB)

    Symko-Davis, M.; Mitchell, R.L.; Witt, C.E.; Thomas, H.P. [National Renewable Energy Laboratory; King, R.[U.S. Department of Energy; Ruby, D.S. [Sandia National Laboratories

    2001-01-18

    The US Photovoltaic (PV) industry has made significant technical advances in crystalline silicon (Si) module manufacturing through the PV Manufacturing R and D Project during the past decade. Funded Si technologies in this project have been Czochralski, cast polycrystalline, edge-defined film-fed growth (EFG) ribbon, string ribbon, and Si-film. Specific R and D Si module-manufacturing categories that have shown technical growth and will be discussed are in crystal growth and processing, wafering, cell fabrication, and module manufacturing. These R and D advancements since 1992 have contributed to a 30% decrease in PV manufacturing costs and stimulated a sevenfold increase in PV production capacity.

  12. Clinical Trials

    Medline Plus

    Full Text Available ... strict scientific standards. These standards protect patients and help produce reliable study results. Clinical trials are one ... are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding The National ...

  13. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ...

  14. Management of advanced pancreatic cancer with gemcitabine plus erlotinib: efficacy and safety results in clinical practice.

    Science.gov (United States)

    Diaz Beveridge, Robert; Alcolea, Vicent; Aparicio, Jorge; Segura, Ángel; García, Jose; Corbellas, Miguel; Fonfría, María; Giménez, Alejandra; Montalar, Joaquin

    2014-01-10

    The combination of gemcitabine and erlotinib is a standard first-line treatment for unresectable, locally advanced or metastatic pancreatic cancer. We reviewed our single centre experience to assess its efficacy and toxicity in clinical practice. Clinical records of patients with unresectable, locally advanced or metastatic pancreatic cancer who were treated with the combination of gemcitabine and erlotinib were reviewed. Univariate survival analysis and multivariate analysis were carried out to indentify independent predictors factors of overall survival. Our series included 55 patients. Overall disease control rate was 47%: 5% of patients presented complete response, 20% partial response and 22% stable disease. Median overall survival was 8.3 months). Cox regression analysis indicated that performance status and locally advanced versus metastatic disease were independent factors of overall survival. Patients who developed acne-like rash toxicity, related to erlotinib administration, presented a higher survival than those patients who did not develop this toxicity. Gemcitabine plus erlotinib doublet is active in our series of patients with advanced pancreatic cancer. This study provides efficacy and safety results similar to those of the pivotal phase III clinical trial that tested the same combination.

  15. Short- and long-term efficacy of a community-based COPD management programme in less advanced COPD: a randomised controlled trial

    NARCIS (Netherlands)

    C.R. van Wetering (Carel); M. Hoogendoorn (Martine); S.J.M. Mol; M.P.M.H. Rutten-van Mölken (Maureen); A.M.W.J. Schols (Annemie)

    2010-01-01

    textabstractBACKGROUND: The effectiveness of pulmonary rehabilitation in advanced COPD is well established, but few data are available in less advanced disease. METHODS: In a 2 year randomised controlled trial, 199 patients with an average moderate airflow obstruction but impaired exercise capacity

  16. Advancing CANDU Technology Through R and D

    International Nuclear Information System (INIS)

    Torgerson, David F.

    1993-01-01

    CANDU reactors are evolving to meet future requirements using incremental changes as opposed to revolutionary design changes. The main elements for advancing the technology reducing capital and operating, increasing capacity factors, increasing passive safety, and enhancing fuel/fuel cycle flexibility. These elements are being addressed by carrying out research and development in the areas of safety, plant systems and components, heavy water production, information technology, fuel channels, and fuel/fuel cycle technology. In safety, the focus is on using the inherent features of CANDU to enhance passive or natural safety concepts, such as the use of the moderator as an effective heat sink, and the development of advanced fuels to improve critical heat flux and to reduce source terms. Plant systems and components work includes improvements to plant systems such as steam generators, heat exchangers, pump seals, and advanced control room technology. Heavy water processes are being developed that can be used with existing hydrogen production plants, or that can be used in a stand-alone mode. Information technology is being developed to cover all aspects of CANDU design, construction, and operation. Fuel channel improvements include elucidation and application of basic materials science for life extension, and the development of advanced non-destructive examination methods. Fuel and fuel cycle work is focusing on LWR/CANDU synergy, such as the use of recovered uranium and the direct use of spent PWR fuel in CANDU reactor, advanced fuels to improve burnup and economics (e. g., the joint AECB/KAERI Conflux program), and low void reactivity fuel to enhance passive safety. This paper gives an overview of some of the R and D supporting these activities, with particular emphasis on Alice's vision for advancing CANDU technology over the next 10 years

  17. A Randomized Trial of Vitamin D Supplementation on Vascular Function in CKD.

    Science.gov (United States)

    Kumar, Vivek; Yadav, Ashok Kumar; Lal, Anupam; Kumar, Vinod; Singhal, Manphool; Billot, Laurent; Gupta, Krishan Lal; Banerjee, Debasish; Jha, Vivekanand

    2017-10-01

    Vitamin D deficiency associates with mortality in patients with CKD, and vitamin D supplementation might mitigate cardiovascular disease risk in CKD. In this randomized, double-blind, placebo-controlled trial, we investigated the effect of cholecalciferol supplementation on vascular function in 120 patients of either sex, aged 18-70 years, with nondiabetic CKD stage 3-4 and vitamin D deficiency (serum 25-hydroxyvitamin D ≤20 ng/ml). We randomized patients using a 1:1 ratio to receive either two directly observed oral doses of cholecalciferol (300,000 IU) or matching placebo at baseline and 8 weeks. The primary outcome was change in endothelium-dependent brachial artery flow-mediated dilation at 16 weeks. Secondary outcome measures included changes in pulse wave velocity and circulating biomarkers. Cholecalciferol supplementation significantly increased endothelium-dependent brachial artery flow-mediated dilation at 16 weeks, whereas placebo did not (between-group difference in mean change: 5.49%; 95% confidence interval, 4.34% to 6.64%; P vitamin D deficiency, vitamin D supplementation may improve vascular function. This study is registered with the Clinical Trials Registry of India (no.: CTRI/2013/05/003648). Copyright © 2017 by the American Society of Nephrology.

  18. Design of the advanced divertor pump cryogenic system for DIII-D

    International Nuclear Information System (INIS)

    Schaubel, K.M.; Baxi, C.B.; Campbell, G.L.; Gootgeld, A.M.; Langhorn, A.R.; Laughon, G.J.; Smith, J.P.; Anderson, P.M.; Menon, M.M.

    1991-11-01

    The design of the cryogenic system for the D3-D advanced divertor cryocondensation pump is presented. The advanced divertor incorporates a baffle chamber and bias ring located near the bottom of the D3-D vacuum vessel. A 50,000 l/s cryocondensation pump will be installed underneath the baffle for plasma particle exhaust. The pump consists of a liquid helium cooled tube operating at 4.3 degrees K and a liquid nitrogen cooled radiation shield. Liquid helium is fed by forced flow through the cryopump. Compressed helium gas flowing through the high pressure side of a heat exchanger is regeneratively cooled by the two-phase helium leaving the pump. The cooled high pressure gaseous helium is than liquefied by a Joule-Thomson expansion valve. The liquid is returned to a storage dewar. The liquid nitrogen for the radiation shield is supplied by forced flow from a bulk storage system. Control of the cryogenic system is accomplished by a programmable logic controller

  19. High-Dose Vitamin D3 during Tuberculosis Treatment in Mongolia. A Randomized Controlled Trial.

    Science.gov (United States)

    Ganmaa, Davaasambuu; Munkhzul, Baatar; Fawzi, Wafaie; Spiegelman, Donna; Willett, Walter C; Bayasgalan, Purev; Baasansuren, Erkhembayar; Buyankhishig, Burneebaatar; Oyun-Erdene, Sereeter; Jolliffe, David A; Xenakis, Theodoros; Bromage, Sabri; Bloom, Barry R; Martineau, Adrian R

    2017-09-01

    Existing trials of adjunctive vitamin D in the treatment of pulmonary tuberculosis (PTB) are variously limited by small sample sizes, inadequate dosing regimens, and high baseline vitamin D status among participants. Comprehensive analyses of the effects of genetic variation in the vitamin D pathway on response to vitamin D supplementation are lacking. To determine the effect of high-dose vitamin D 3 on response to antimicrobial therapy for PTB and to evaluate the influence of single-nucleotide polymorphisms (SNPs) in vitamin D pathway genes on response to adjunctive vitamin D 3 . We conducted a clinical trial in 390 adults with PTB in Ulaanbaatar, Mongolia, who were randomized to receive four biweekly doses of 3.5 mg (140,000 IU) vitamin D 3 (n = 190) or placebo (n = 200) during intensive-phase antituberculosis treatment. The intervention elevated 8-week serum 25-hydroxyvitamin D concentrations (154.5 nmol/L vs. 15.2 nmol/L in active vs. placebo arms, respectively; 95% confidence interval for difference, 125.9-154.7 nmol/L; P vitamin D 3 accelerated sputum culture conversion in patients with one or more minor alleles for SNPs in genes encoding the vitamin D receptor (rs4334089, rs11568820) and 25-hydroxyvitamin D 1α-hydroxylase (CYP27B1: rs4646536) (adjusted hazard ratio ≥ 1.47; P for interaction ≤ 0.02). Vitamin D 3 did not influence time to sputum culture conversion in the study population overall. Effects of the intervention were modified by SNPs in VDR and CYP27B1. Clinical trial registered with www.clinicaltrials.gov (NCT01657656).

  20. Latest advances in the manufacturing of 3D rechargeable lithium microbatteries

    Science.gov (United States)

    Ferrari, Stefania; Loveridge, Melanie; Beattie, Shane D.; Jahn, Marcus; Dashwood, Richard J.; Bhagat, Rohit

    2015-07-01

    Recent advances in micro- and nano-electromechanical systems (MEMS/NEMS) technology have led to a niche industry of diverse small-scale devices that include microsensors, micromachines and drug-delivery systems. For these devices, there is an urgent need to develop Micro Lithium Ion Batteries (MLIBs) with dimensions on the scale 1-10 mm3 enabling on-board power delivery. Unfortunately, power limitations are inherent in planar 2D cells and only the advent of 3D designs and microarchitectures will lead to a real breakthrough in the microbattery technology. During the last few years, many efforts to optimise MLIBs were discussed in literature, both in the planar and 3D configurations. This review highlights the importance of 3D microarchitectured electrodes to fabricate batteries that can be device-integrated with exceptionally high specific power density coupled with exquisite miniaturisation. A wide literature overview is provided and recent advances in manufacturing routes to 3D-MLIBs comprising materials synthesis, device formulation, device testing are herein discussed. The advent of simple, economic and easily scalable fabrication processes such as 3D printing will have a decisive role in the growing field of micropower sources and microdevices.

  1. Randomised clinical trial: alginate (Gaviscon Advance) vs. placebo as add-on therapy in reflux patients with inadequate response to a once daily proton pump inhibitor.

    Science.gov (United States)

    Reimer, C; Lødrup, A B; Smith, G; Wilkinson, J; Bytzer, P

    2016-04-01

    Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression. To assess the efficacy of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using the Heartburn Reflux Dyspepsia Questionnaire (HRDQ). Based on symptom score during run-in, eligible patients were randomised to Gaviscon Advance 10 mL four times a day or placebo in addition to a once daily PPI. The primary endpoint was change in HRDQ score post-treatment compared to baseline. One hundred and thirty-six patients were randomised. Change in HRDQ reflux score was significantly greater for Gaviscon Advance (mean: -5.0, s.d.: 4.7) than for placebo (mean: -3.5, s.d.: 5.5) with an LS mean difference of 1.6 [95% CI -3.1 to -0.1], P = 0.03. A decrease in the mean (s.d.) number of nights with symptoms was observed from 3.6 (2.8) to 3.0 (3.0) in the placebo group and from 3.9 (2.8) to 2.2 (2.7) for the Gaviscon Advance group. This reduction was significantly greater in the Gaviscon Advance group than in the placebo group [LS mean difference = -0.9, 95% CI (-1.6 to -0.2), P < 0.01]. In patients with residual reflux symptoms despite PPI treatment, adding an alginate offers additional decrease in the burden of reflux symptoms (EudraCT/IND Number: 2011-005486-21). © 2016 John Wiley & Sons Ltd.

  2. Evaluating the Accuracy of Results for Teacher Implemented Trial-Based Functional Analyses.

    Science.gov (United States)

    Rispoli, Mandy; Ninci, Jennifer; Burke, Mack D; Zaini, Samar; Hatton, Heather; Sanchez, Lisa

    2015-09-01

    Trial-based functional analysis (TBFA) allows for the systematic and experimental assessment of challenging behavior in applied settings. The purposes of this study were to evaluate a professional development package focused on training three Head Start teachers to conduct TBFAs with fidelity during ongoing classroom routines. To assess the accuracy of the TBFA results, the effects of a function-based intervention derived from the TBFA were compared with the effects of a non-function-based intervention. Data were collected on child challenging behavior and appropriate communication. An A-B-A-C-D design was utilized in which A represented baseline, and B and C consisted of either function-based or non-function-based interventions counterbalanced across participants, and D represented teacher implementation of the most effective intervention. Results showed that the function-based intervention produced greater decreases in challenging behavior and greater increases in appropriate communication than the non-function-based intervention for all three children. © The Author(s) 2015.

  3. Relevance of positive cardiovascular outcome trial results in clinical practice: perspectives from the Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes (ACROSS T2D

    Directory of Open Access Journals (Sweden)

    Schernthaner G

    2017-12-01

    Full Text Available Guntram Schernthaner,1 Kamlesh Khunti,2 Chaim Lotan,3 Michel Burnier,4 Heinz Drexel,5 Martin Prázný61Department of Medicine I, Rudolfstiftung Hospital, Vienna, Austria; 2Diabetes Research Centre, Leicester General Hospital, Leicester, UK; 3Cardiovascular Division, Hadassah Medical Centre, Jerusalem, Israel; 4Division of Nephrology and Hypertension Consultation, University Hospital of Lausanne, Lausanne, Switzerland; 5Vorarlberg Institute for Vascular Investigation and Treatment, Feldkirch, Austria; 6Charles University, Prague, Czech RepublicAbstract: Type 2 diabetes (T2D imposes a substantial disease burden, predominantly from cardiovascular disease (CVD, which accounts for >50% of deaths in this population and leads to a 12-year reduction in the life expectancy of a 60-year-old male patient with T2D and CVD compared with the general population. The results from mandatory cardiovascular outcome trials (CVOTs are therefore of great interest in the field. The Academy for Cardiovascular Risk, Outcomes and Safety Studies in Type 2 Diabetes meeting program aims to bring together experts from several associated disciplines to provide fair and balanced resources for those involved in the management of patients with T2D. This publication represents the opinions of the faculty on the key learnings from the meeting held in Vienna in the spring of 2017. In particular, we detail how data from the EMPA-REG OUTCOME® [cardiovascular outcomes trial of empagliflozin] and Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER® (liraglutide CVOTs can be practically interpreted across clinical specialities. It is hoped that this translation of CVOT data will achieve a dual treatment paradigm for the management of both raised glucose levels and CV risk in patients with T2D. Keywords: type 2 diabetes, cardiovascular disease, CVOT, SGLT2 inhibitors, GLP-1 agonists, DPP-4 inhibitors

  4. Study Protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease

    Directory of Open Access Journals (Sweden)

    Brafman-Kennedy Barbara

    2011-05-01

    Full Text Available Abstract Background Breathlessness in advanced disease causes significant distress to patients and carers and presents management challenges to health care professionals. The Breathlessness Intervention Service (BIS seeks to improve the care of breathless patients with advanced disease (regardless of cause through the use of evidence-based practice and working with other healthcare providers. BIS delivers a complex intervention (of non-pharmacological and pharmacological treatments via a multi-professional team. BIS is being continuously developed and its impact evaluated using the MRC's framework for complex interventions (PreClinical, Phase I and Phase II completed. This paper presents the protocol for Phase III. Methods/Design Phase III comprises a pragmatic, fast-track, single-blind randomised controlled trial of BIS versus standard care. Due to differing disease trajectories, the service uses two broad service models: one for patients with malignant disease (intervention delivered over two weeks and one for patients with non-malignant disease (intervention delivered over four weeks. The Phase III trial therefore consists of two sub-protocols: one for patients with malignant conditions (four week protocol and one for patients with non-malignant conditions (eight week protocol. Mixed method interviews are conducted with patients and their lay carers at three to five measurement points depending on randomisation and sub-protocol. Qualitative interviews are conducted with referring and non-referring health care professionals (malignant disease protocol only. The primary outcome measure is 'patient distress due to breathlessness' measured on a numerical rating scale (0-10. The trial includes economic evaluation. Analysis will be on an intention to treat basis. Discussion This is the first evaluation of a breathlessness intervention for advanced disease to have followed the MRC framework and one of the first palliative care trials to use fast

  5. Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study

    Directory of Open Access Journals (Sweden)

    Taylor Roderick

    2009-11-01

    Full Text Available Abstract Background Randomised, placebo-controlled trials are needed to provide evidence demonstrating safe, effective interventions that reduce falls and fractures in the elderly. The quality of a clinical trial is dependent on successful recruitment of the target participant group. This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration. The characteristics of study participants at baseline are also described for this study. Methods The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol or placebo every autumn for five consecutive years. A variety of recruitment strategies were employed to attract potential participants. Results Of the 2,317 participants randomised onto the study, 74% (n = 1716/2317 were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the 18 months of recruiting. A total of 70% of all participants were recruited as a result of targeted mail-out. The response rate from the letters increased from 2 to 7% following revision of the material by a public relations company. Participant demographic or risk factor profile did not differ between those recruited by targeted mail-outs compared with other methods. Conclusion The most successful recruitment strategy was the targeted mail-out and the response rate was no higher in the local region where the study had extensive exposure through other recruiting strategies. The strategies that were labour-intensive and did not result in successful recruitment include the activities directed towards the GP medical centres

  6. Modeling learning and memory using verbal learning tests: results from ACTIVE.

    Science.gov (United States)

    Gross, Alden L; Rebok, George W; Brandt, Jason; Tommet, Doug; Marsiske, Michael; Jones, Richard N

    2013-03-01

    To investigate the influence of memory training on initial recall and learning. The Advanced Cognitive Training for Independent and Vital Elderly study of community-dwelling adults older than age 65 (n = 1,401). We decomposed trial-level recall in the Auditory Verbal Learning Test (AVLT) and Hopkins Verbal Learning Test (HVLT) into initial recall and learning across trials using latent growth models. Trial-level increases in words recalled in the AVLT and HVLT at each follow-up visit followed an approximately logarithmic shape. Over the 5-year study period, memory training was associated with slower decline in Trial 1 AVLT recall (Cohen's d = 0.35, p = .03) and steep pre- and posttraining acceleration in learning (d = 1.56, p learning, d = 3.10, p memory-trained group had a higher level of recall than the control group through the end of the 5-year study period despite faster decline in learning. This study contributes to the understanding of the mechanisms by which training benefits memory and expands current knowledge by reporting long-term changes in initial recall and learning, as measured from growth models and by characterization of the impact of memory training on these components. Results reveal that memory training delays the worsening of memory span and boosts learning.

  7. The Effect of Vitamin D and Calcium plus Vitamin D during Pregnancy on Pregnancy and Birth Outcomes: a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Sakineh Mohammad-Alizadeh-Charandabi

    2015-03-01

    Full Text Available Introduction: Evidence suggests a high prevalence of calcium and vitamin D deficiencies exists in both pregnant women and babies. Adequate intake of micronutrients has great importance especially during pregnancy and lactation period. Thus, the present study aimed at assessing the effect of vitamin D and calcium-vitamin D on pregnancy and birth outcomes (including duration of pregnancy, type of delivery and infant anthropometric indicators. Methods: A randomized, controlled, clinical, triple-blind trial conducted on 126 pregnant women referring to Tabriz health centers in 2013-14. Subjects were allocated into three groups using block randomization. Interventional groups received vitamin D, calcium-vitamin D and placebo pills daily for 60 days. ANCOVA and Chi-square tests were used for data analysis. Results: By controlling BMI before and during pregnancy, there were no significant differences between the group in average neonatal weight, height and head circumference, duration of pregnancy, type of delivery and gestational age at the time of delivery. Conclusion: The results show that calcium-vitamin D and vitamin D have no effect on duration of pregnancy, type of delivery and infant anthropometric indicators.

  8. WE-G-BRB-04: Leveraging Innovation to Design Future Clinical Trials

    International Nuclear Information System (INIS)

    Michalski, J.

    2015-01-01

    Over the past 20 years the NIH has funded individual grants, program projects grants, and clinical trials which have been instrumental in advancing patient care. The ways that each grant mechanism lends itself to the different phases of translating research into clinical practice will be described. Major technological innovations, such as IMRT and proton therapy, have been advanced with R01-type and P01-type funding and will be discussed. Similarly, the role of program project grants in identifying and addressing key hypotheses on the potential of 3D conformal therapy, normal tissue-guided dose escalation and motion management will be described. An overview will be provided regarding how these technological innovations have been applied to multi-institutional NIH-sponsored trials. Finally, the panel will discuss regarding which research questions should be funded by the NIH to inspire the next advances in radiation therapy. Learning Objectives: Understand the different funding mechanisms of the NIH Learn about research advances that have led to innovation in delivery Review achievements due to NIH-funded program project grants in radiotherapy over the past 20 years Understand example advances achieved with multi-institutional clinical trials NIH

  9. Evaluation of the trial design studies for an advanced marine reactor, (1)

    International Nuclear Information System (INIS)

    1988-03-01

    The trial design of three type reactors, semi-integrated, integrated and integrated (self-pressurized) type, was carried out in order to clarify the reactor type for the advanced marine reactor that would be developed for its realization in future and in order to extract its research and development theme. The trial design was carried and finished as for the three type reactors in same specifications in order to improve the following characteristics, small in size, light in weight, high in safety and reliability, and economic. In this report, a comparison and review of the following items are described as for the above three type reactors, (1) specifications, (2) shielding, (3) refueling, (4) in-service inspection, (5) analysis of the transients and accidents, (6) piping systems, (7) control systems, (8) dynamic analysis, (9) overall comparison, (10) research and development theme and theme for study in future. (author)

  10. Fracture Surgery of the extremities with the intra-operative use of 3D-RX: A randomized multicenter trial (EF3X-trial

    Directory of Open Access Journals (Sweden)

    Marmor Meir

    2011-07-01

    Full Text Available Abstract Background Posttraumatic osteoarthritis can develop after an intra-articular extremity fracture, leading to pain and loss of function. According to international guidelines, anatomical reduction and fixation are the basis for an optimal functional result. In order to achieve this during fracture surgery, an optimal view on the position of the bone fragments and fixation material is a necessity. The currently used 2D-fluoroscopy does not provide sufficient insight, in particular in cases with complex anatomy or subtle injury, and even an 18-26% suboptimal fracture reduction is reported for the ankle and foot. More intra-operative information is therefore needed. Recently the 3D-RX-system was developed, which provides conventional 2D-fluoroscopic images as well as a 3D-reconstruction of bony structures. This modality provides more information, which consequently leads to extra corrections in 18-30% of the fracture operations. However, the effect of the extra corrections on the quality of the anatomical fracture reduction and fixation as well as on patient relevant outcomes has never been investigated. The objective of this study protocol is to investigate the effectiveness of the intra-operative use of the 3D-RX-system as compared to the conventional 2D-fluoroscopy in patients with traumatic intra-articular fractures of the wrist, ankle and calcaneus. The effectiveness will be assessed in two different areas: 1 the quality of fracture reduction and fixation, based on the current golden standard, Computed Tomography. 2 The patient-relevant outcomes like functional outcome range of motion and pain. In addition, the diagnostic accuracy of the 3D-RX-scan will be determined in a clinical setting and a cost-effectiveness as well as a cost-utility analysis will be performed. Methods/design In this protocol for an international multicenter randomized clinical trial, adult patients (age > 17 years with a traumatic intra-articular fracture of the

  11. Vitamin D as supplementary treatment for tuberculosis: a double-blind, randomized, placebo-controlled trial.

    Science.gov (United States)

    Wejse, Christian; Gomes, Victor F; Rabna, Paulo; Gustafson, Per; Aaby, Peter; Lisse, Ida M; Andersen, Paul L; Glerup, Henning; Sodemann, Morten

    2009-05-01

    Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis. To test whether vitamin D supplementation of patients with tuberculosis (TB) improved clinical outcome and reduced mortality. We conducted a randomized, double-blind, placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau. We included 365 adult patients with TB starting antituberculosis treatment; 281 completed the 12-month follow-up. The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment. The primary outcome was reduction in a clinical severity score (TBscore) for all patients with pulmonary TB. The secondary outcome was 12-month mortality. No serious adverse effects were reported; mild hypercalcemia was rare and present in both arms. Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo. Overall mortality was 15% (54 of 365) at 1 year of follow-up and similar in both arms (30 of 187 for vitamin D treated and 24 of 178 for placebo; relative risk, 1.19 [0.58-1.95]). HIV infection was seen in 36% (131 of 359): 21% (76 of 359) HIV-1, 10% (36 of 359) HIV-2, and 5% (19 of 357) HIV-1+2. Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB; it is possible that the dose used was insufficient. Clinical trial registered with www.controlled-trials.com/isrctn (ISRCTN35212132).

  12. Health related quality of life in locally advanced NSCLC treated with high dose radiotherapy and concurrent chemotherapy or cetuximab – Pooled results from two prospective clinical trials

    International Nuclear Information System (INIS)

    Hallqvist, Andreas; Bergman, Bengt; Nyman, Jan

    2012-01-01

    Background: In non-small cell lung cancer (NSCLC) stage III, data on patient reported health-related quality of life (HRQL) are scarce, especially regarding concurrent chemoradiotherapy. Aims: To evaluate HRQL in patients treated with high dose radiotherapy combined with concurrent chemotherapy or the antibody cetuximab. Methods: The study population comprised all patients enroled in either of two phase II trials in locally advanced NSCLC performed in Sweden 2002–2007. The RAKET trial investigated three different ways of increasing local control (accelerated hyperfractionated treatment or concurrent daily or weekly chemotherapy). The Satellite trial evaluated the addition of cetuximab to thoracic irradiation. HRQL was measured at four time points: At baseline, before radiotherapy, 4–6 weeks after radiotherapy and at 3 months follow-up, using the EORTC QLQ-C30 and LC14 set of questionnaires. Results: 154/220 patients (65%) who completed HRQL assessments at all time points were included in the longitudinal study. There was a significant decline over time regarding most functioning measures. Dyspnoea and fatigue gradually deteriorated without recovery after completed treatment. Chemotherapy related symptoms showed a transient deterioration, whereas radiotherapy related esophagitis had not fully recovered at 3 months. Patients with stage IIIA disease tended to recover better regarding global QL, fatigue and dyspnoea compared to patients with stage IIIB. Patients with WHO performance status (PS) 0 reported improved global QL and less fatigue over time compared with PS 1. Concurrent chemotherapy was associated with more pronounced fatigue and dysphagia, and worse global QL compared with concurrent cetuximab. Baseline physical functioning was an independent predictor of overall survival. Conclusion: Patients undergoing high dose thoracic radiotherapy combined with chemotherapy or cetuximab reported a gradual deterioration in functioning, dyspnoea and fatigue, while

  13. Pemetrexed plus platinum as the first-line treatment option for advanced non-small cell lung cancer: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Ming Li

    Full Text Available To compare the efficacy and toxicities of pemetrexed plus platinum with other platinum regimens in patients with previously untreated advanced non-small cell lung cancer (NSCLC.A meta-analysis was performed using trials identified through PubMed, EMBASE, and Cochrane databases. Two investigators independently assessed the quality of the trials and extracted data. The outcomes included overall survival (OS, progression-free survival (PFS, response rate (RR, and different types of toxicity. Hazard ratios (HRs, odds ratios (ORs and their 95% confidence intervals (CIs were pooled using RevMan software.Four trials involving 2,518 patients with previously untreated advanced NSCLC met the inclusion criteria. Pemetrexed plus platinum chemotherapy (PPC improved survival compared with other platinum-based regimens (PBR in patients with advanced NSCLC (HR = 0.91, 95% CI: 0.83-1.00, p = 0.04, especially in those with non-squamous histology (HR = 0.87, 95% CI: 0.77-0.98, p = 0.02. No statistically significant improvement in either PFS or RR was found in PPC group as compared with PBR group (HR = 1.03, 95% CI: 0.94-1.13, p = 0.57; OR = 1.15, 95% CI: 0.95-1.39, p = 0.15, respectively. Compared with PBR, PPC led to less grade 3-4 neutropenia and leukopenia but more grade 3-4 nausea. However, hematological toxicity analysis revealed significant heterogeneities.Our results suggest that PPC in the first-line setting leads to a significant survival advantage with acceptable toxicities for advanced NSCLC patients, especially those with non-squamous histology, as compared with other PRB. PPC could be considered as the first-line treatment option for advanced NSCLC patients, especially those with non-squamous histology.

  14. Influence of vitamin D status and vitamin D3 supplementation on genome wide expression of white blood cells: a randomized double-blind clinical trial.

    Directory of Open Access Journals (Sweden)

    Arash Hossein-nezhad

    Full Text Available Although there have been numerous observations of vitamin D deficiency and its links to chronic diseases, no studies have reported on how vitamin D status and vitamin D3 supplementation affects broad gene expression in humans. The objective of this study was to determine the effect of vitamin D status and subsequent vitamin D supplementation on broad gene expression in healthy adults. (Trial registration: ClinicalTrials.gov NCT01696409.A randomized, double-blind, single center pilot trial was conducted for comparing vitamin D supplementation with either 400 IUs (n = 3 or 2000 IUs (n = 5 vitamin D3 daily for 2 months on broad gene expression in the white blood cells collected from 8 healthy adults in the winter. Microarrays of the 16 buffy coats from eight subjects passed the quality control filters and normalized with the RMA method. Vitamin D3 supplementation that improved serum 25-hydroxyvitamin D concentrations was associated with at least a 1.5 fold alteration in the expression of 291 genes. There was a significant difference in the expression of 66 genes between subjects at baseline with vitamin D deficiency (25(OHD20 ng/ml. After vitamin D3 supplementation gene expression of these 66 genes was similar for both groups. Seventeen vitamin D-regulated genes with new candidate vitamin D response elements including TRIM27, CD83, COPB2, YRNA and CETN3 which have been shown to be important for transcriptional regulation, immune function, response to stress and DNA repair were identified.Our data suggest that any improvement in vitamin D status will significantly affect expression of genes that have a wide variety of biologic functions of more than 160 pathways linked to cancer, autoimmune disorders and cardiovascular disease with have been associated with vitamin D deficiency. This study reveals for the first time molecular finger prints that help explain the nonskeletal health benefits of vitamin D.ClinicalTrials.gov NCT01696409.

  15. Recruitment and Early Retention of Women with Advanced Breast Cancer in a Complementary and Alternative Medicine Trial

    Directory of Open Access Journals (Sweden)

    Alla Sikorskii

    2011-01-01

    Full Text Available More than 80% of women with breast cancer are now reported to be using complementary and alternative medicine (CAM therapies during conventional treatment. A randomized clinical trial (RCT of reflexology with late stage breast cancer patients serves as the data source for this article. The purposes were to investigate: (i reasons for refusal to participate in a RCT of reflexology; (ii the differences between those who completed the baseline interview and those who dropped out before baseline; and (iii the utility of the Palliative Prognostic Score (PPS as a prognostic screening tool in minimizing early attrition (before baseline from the trial. Eligible women (N = 400 approached at 12 cancer centers in the Midwest had advanced breast cancer, were on chemotherapy or hormonal therapy, and had a PPS of 11 or less. Comparisons of those who dropped out early (N = 33 to those who stayed in the trial (N = 240 were carried out using Wilcoxon rank, t-, chi-squared and Fisher's exact tests. The reasons of being “too sick” or “overwhelmed” were given by less than 12% of the women who refused to participate. There was a higher early dropout rate among black women compared to other (primarily white women (P = .01. Cancer recurrence and metastasis, age, and the PPS were not predictive of early retention of women. Specialized techniques may be needed to ensure black women remain in the trial once consented. Women with advanced disease were likely to enter and remain in the trial despite deterioration in health.

  16. Favorable effects of insulin sensitizers pertinent to peripheral arterial disease in type 2 diabetes: results from the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial.

    Science.gov (United States)

    Althouse, Andrew D; Abbott, J Dawn; Sutton-Tyrrell, Kim; Forker, Alan D; Lombardero, Manuel S; Buitrón, L Virginia; Pena-Sing, Ivan; Tardif, Jean-Claude; Brooks, Maria Mori

    2013-10-01

    The aim of this manuscript was to report the risk of incident peripheral arterial disease (PAD) in a large randomized clinical trial that enrolled participants with stable coronary artery disease and type 2 diabetes and compare the risk between assigned treatment arms. The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial randomly assigned participants to insulin sensitization (IS) therapy versus insulin-providing (IP) therapy for glycemic control. Results showed similar 5-year mortality in the two glycemic treatment arms. In secondary analyses reported here, we examine the effects of treatment assignment on the incidence of PAD. A total of 1,479 BARI 2D participants with normal ankle-brachial index (ABI) (0.91-1.30) were eligible for analysis. The following PAD-related outcomes are evaluated in this article: new low ABI≤0.9, a lower-extremity revascularization, lower-extremity amputation, and a composite of the three outcomes. During an average 4.6 years of follow-up, 303 participants experienced one or more of the outcomes listed above. Incidence of the composite outcome was significantly lower among participants assigned to IS therapy than those assigned to IP therapy (16.9 vs. 24.1%; Pdiabetes who are free from PAD, a glycemic control strategy of insulin sensitization may be the preferred therapeutic strategy to reduce the incidence of PAD and subsequent outcomes.

  17. Clinical factors of response in patients with advanced ovarian cancer participating in early phase clinical trials.

    Science.gov (United States)

    George, Angela; Kristeleit, Rebecca; Rafii, Saeed; Michie, Caroline O; Bowen, Rebecca; Michalarea, Vasiliki; van Hagen, Tom; Wong, Mabel; Rallis, Grigorios; Molife, L Rhoda; Lopez, Juanita; Banerji, Udai; Banerjee, Susana N; Gore, Martin E; de Bono, Johann S; Kaye, Stan B; Yap, Timothy A

    2017-05-01

    Drug resistance to conventional anticancer therapies is almost inevitable in patients with advanced ovarian cancer (AOC), limiting their available treatment options. Novel phase I trial therapies within a dedicated drug development unit may represent a viable alternative; however, there is currently little evidence for patient outcomes in such patients. To address this, we undertook a retrospective review of patients with AOC allocated to phase I trials in the Drug Development Unit at Royal Marsden Hospital (RMH) between June 1998 and October 2010. A total of 200 AOC patients with progressive disease were allocated to ≥1 trial each, with a total of 281 allocations. Of these, 135 (68%) patients commenced ≥1 trial (mean 1.4 [1-8]), totaling 216 allocated trials; 65 (32%) patients did not start due to deterioration resulting from rapidly progressive disease (63 patients) or patient choice (2 patients). Response Evaluation Criteria in Solid Tumours (RECIST) complete/partial responses (CR/PR) were observed in 43 (20%) of those starting trials, including those on poly(ADP-ribose) polymerase (PARP) inhibitors (18/79 [23%]), antiangiogenics (9/65 [14%]) and chemotherapy combinations (14/43 [33%]). Factors associated with CR/PR included: fewer prior treatments, platinum-sensitive disease, CR/PR with prior therapy, (the United States-based) Eastern Cooperative Oncology Group (ECOG) performance status score, fewer metastatic sites, higher albumin and haemoglobin levels, lower white cell counts and baseline CA125 levels, germline BRCA1/2 mutations and better RMH Prognostic Score. Mean survival was 32° months for patients who achieved CR/PR. Treatments were generally well tolerated. Most patients with AOC (134/200 [67%]) received ≥1 subsequent line of therapy after phase I trials. Our data suggest that phase I trial referrals should be considered earlier in the AOC treatment pathway and before the onset of rapid disease progression particularly with the emergence of

  18. Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial.

    Science.gov (United States)

    Nuzzo, Francesco; Morabito, Alessandro; Gravina, Adriano; Di Rella, Francesca; Landi, Gabriella; Pacilio, Carmen; Labonia, Vincenzo; Rossi, Emanuela; De Maio, Ermelinda; Piccirillo, Maria Carmela; D'Aiuto, Giuseppe; Thomas, Renato; Rinaldo, Massimo; Botti, Gerardo; Di Bonito, Maurizio; Di Maio, Massimo; Gallo, Ciro; Perrone, Francesco; de Matteis, Andrea

    2011-02-16

    To evaluate whether weekly schedules of docetaxel-based chemotherapy were superior to 3-weekly ones in terms of quality of life in locally advanced or metastatic breast cancer. Patients with locally advanced or metastatic breast cancer, aged ≤ 70 years, performance status 0-2, chemotherapy-naive for metastatic disease, were eligible. They were randomized to weekly or 3-weekly combination of docetaxel and epirubicin, if they were not treated with adjuvant anthracyclines, or docetaxel and capecitabine, if treated with adjuvant anthracyclines. Primary end-point was global quality of life change at 6-weeks, measured by EORTC QLQ-C30. With two-sided alpha 0.05 and 80% power for 35% effect size, 130 patients per arm were needed. From February 2004 to March 2008, 139 patients were randomized, 70 to weekly and 69 to 3-weekly arm; 129 and 89 patients filled baseline and 6-week questionnaires, respectively. Global quality of life was better in the 3-weekly arm (p = 0.03); patients treated with weekly schedules presented a significantly worsening in role functioning and financial scores (p = 0.02 and p < 0.001). Neutropenia and stomatitis were worse in the 3-weekly arm, where two toxic deaths were observed. Overall response rate was 39.1% and 33.3% in 3-weekly and weekly arms; hazard ratio of progression was 1.29 (95% CI: 0.84-1.97) and hazard ratio of death was 1.38 (95% CI: 0.82-2.30) in the weekly arm. In this trial, the weekly schedules of docetaxel-based chemotherapy appear to be inferior to the 3-weekly one in terms of quality of life in patients with locally advanced or metastatic breast cancer. ClinicalTrials.gov NCT00540800.

  19. Challenges in safety regulation of R and D activities for advanced technologies in DAE units

    International Nuclear Information System (INIS)

    Shukla, Dinesh Kumar

    2016-01-01

    DAE is engaged in intensive research and developmental activities, especially for advanced technologies such as accelerators, lasers, supercomputers, advanced materials and instrumentation. The starting point of an R and D project might be a hypothesis to be tested, problem to be solved, or the performance of an item to be improved, and there may be many possible solutions and technologies that could be used. R and D is quite different from designing, constructing, operating a plant. In these, precisely described result can be defined from the beginning and can be described in design specifications, process descriptions and procedures. However, while established procedures may be available to begin an R and D project, deviation from these procedures may occur often as a legitimate component of the conduct of R and D. Nevertheless, the R and D activities have to be performed in a manner which provides assurance that safety requirements are adequately addressed. Hence, the regulatory approach for enforcing the safety regulation in such facilities is also not as rigid as those for an operating industry. This paper is aimed to discuss some of the key challenges in regulating such R and D activities and also attempts to suggest a way forward. (author)

  20. A randomized controlled trial of vitamin D supplementation on perinatal depression: in Iranian pregnant mothers.

    Science.gov (United States)

    Vaziri, Farideh; Nasiri, Samira; Tavana, Zohreh; Dabbaghmanesh, Mohammad Hossein; Sharif, Farkhondeh; Jafari, Peyman

    2016-08-20

    Mood disorders in pregnancy and post-partum period are common and considered as a public health issue. Researchers have studied the relationship between low serum vitamin D concentration and perinatal depression, although no clinical trial has been conducted on vitamin D's effects on depression related to childbirth. This study evaluated the effect of vitamin D3 supplementation on perinatal depression scores. This randomized clinical trial was done in pregnant women who were under prenatal care in a teaching hospital in Shiraz, Iran. The inclusion criteria were: being 18 years or older, no history of mental illness and internal diseases, a singleton live fetus, without any pregnancy complications, gestational age of 26-28 weeks upon enrollment, and depression score of 0 to 13. The Edinburgh Postnatal Depression scale was used to evaluate depression scores. A total of 169 participants were assigned to the two groups of placebo and vitamin D through block randomization design. Vitamin D group received 2000 IU vitamin D3 daily from 26 to 28 weeks of gestation until childbirth. Maternal serum 25-hydroxyvitamin D concentrations were measured at baseline and childbirth. Besides, depression scores were evaluated four times: at 26-28 and 38-40 weeks of gestation, and finally at 4 and 8 weeks after birth. The two groups were similar in relation to baseline 25-hydroxyvitamin D concentrations. However, at childbirth, the vitamin D group had significantly higher 25-hydroxyvitamin D concentration in comparison to the control group (p depression score (r = 0.13, p = 0.09). There was no significant difference between the two study groups in relation to the baseline depression score. While, the vitamin D group had greater reduction in depression scores than the control group at 38-40 weeks of gestation (p = 0.01) also, at 4 and 8 weeks after birth (p depression levels. We suggest further clinical trial in pregnant mothers who are at risk for postnatal depression

  1. R and D limited partnerships (possible applications in advanced communications satellite technology experiment program)

    Science.gov (United States)

    1985-01-01

    Typical R&D limited partnership arrangements, advantages and disadvantages of R&D limited partnership (RDLPs) and antitrust and tax implications are described. A number of typical forms of RDLPs are described that may be applicable for use in stimulating R&D and experimental programs using the advanced communications technology satellite. The ultimate goal is to increase the rate of market penetration of goods and/or services based upon advanced satellite communications technology. The conditions necessary for these RDLP forms to be advantageous are outlined.

  2. Adjuvant radiochemotherapy in locally advanced gastric cancer. Treatment results and analysis of possible prognostic factors

    Energy Technology Data Exchange (ETDEWEB)

    Martin Sanchez, Mercedes [Hospital Universitario Ramon y Cajal, Department of Radiation Oncology, Madrid (Spain); Perez Escutia, Maria Angeles; Guardado Gonzales, Sandra; Cabezas Mendoza, Ana Maria; Campos Bonel, Arantxa; Perez Montero, Hector; Ambrosi, Rafael d' ; Perez-Regadera Gomez, Jose Fermin [Hospital Universitario 12 de Octubre, Department of Radiation Oncology, Madrid (Spain); Lora Pablos, David [Hospital Universitario 12 de Octubre, Department of Statistics, Madrid (Spain)

    2017-12-15

    The aim of this study was to report the clinical outcome and toxicity of radiochemotherapy in locally advanced gastric cancer (LAGC) patients treated according to the Intergroup 116 trial protocol in our institution. We retrospectively reviewed 105 patients with LAGC treated with radical surgery and adjuvant radiochemotherapy. We analyzed overall survival (OS), disease-free survival (DFS), locoregional failure-free survival (LFS), prognostic factors and toxicity. The mean follow-up was 96.48 months. The majority of tumors were T3-T4 (75%) and 86.6% had nodal metastases. The OS, DFS and LFS rates to 3 years were 53.48%, 52.75% and 81.65%, respectively and to 5 years 40%, 46.73% and 76.77% respectively. The univariate analysis showed that N stage < N2, TN stage < IIIA, R0 resection and N-ratio < 3 were statistically significant prognostic factors for OS and DFS, T stage < T4 for OS and N-ratio < 3 for LFS. The group with D2 lymphadenectomy had worse LFS than the D1 group (65.2% vs 88.1%, respectively, p = 0.039) probably due to a significant difference in the proportion node positive patients in the D2 group (94% vs. 78%; p = 0.027). In the multivariate analysis, only R0 resection was statistically significant factor for improved OS (p = 0.018). Acute grade III-IV gastrointestinal and hematologic toxicity rates were 8.5% and 15.2%, respectively and 89.5% completed treatment as planned. Our results are consistent with those of the Intergroup-0116 trial for LAGC in terms of survival. This regimen is well tolerated and with acceptable toxicity. An R0 resection was an independent prognostic factor for improved OS. (orig.) [German] Das Ziel dieser Studie ist es, ueber die klinischen Ergebnisse und die Toxizitaet der adjuvanten Radiochemotherapie bei lokal fortgeschrittenem Magenkarzinom (LFM) entsprechend der Intergroup-0116-Studie in unserem Krankenhaus zu berichten. Es erfolgte eine retrospektive Auswertung von 105 Patienten mit LFM, welche mittels Operation und

  3. Randomized Clinical Trial of the Effectiveness of a Home-Based Advanced Practice Psychiatric Nurse Intervention: Outcomes for Individuals with Serious Mental Illness and HIV

    Science.gov (United States)

    Hanrahan, Nancy P.; Wu, Evan; Kelly, Deena; Aiken, Linda H.; Blank, Michael B.

    2011-01-01

    Individuals with serious mental illness have greater risk for contracting HIV, multiple morbidities, and die 25 years younger than the general population. This high need and high cost subgroup face unique barriers to accessing required health care in the current health care system. The effectiveness of an advanced practice nurse model of care management was assessed in a four-year random controlled trial. Results are reported in this paper. In a four-year random controlled trial, a total of 238 community-dwelling individuals with HIV and serious mental illness (SMI) were randomly assigned to an intervention group (n=128) or to a control group (n=110). Over 12 months, the intervention group received care management from advanced practice psychiatric nurse, and the control group received usual care. The intervention group showed significant improvement in depression (P=.012) and the physical component of health-related quality of life (P=.03) from baseline to 12 months. The advanced practice psychiatric nurse intervention is a model of care that holds promise for a higher quality of care and outcomes for this vulnerable population. PMID:21935499

  4. Regorafenib for the Treatment of Advanced Gastric Cancer (INTEGRATE): A Multinational Placebo-Controlled Phase II Trial.

    Science.gov (United States)

    Pavlakis, Nick; Sjoquist, Katrin M; Martin, Andrew J; Tsobanis, Eric; Yip, Sonia; Kang, Yoon-Koo; Bang, Yung-Jue; Alcindor, Thierry; O'Callaghan, Christopher J; Burnell, Margot J; Tebbutt, Niall C; Rha, Sun Young; Lee, Jeeyun; Cho, Jae-Yong; Lipton, Lara R; Wong, Mark; Strickland, Andrew; Kim, Jin Won; Zalcberg, John R; Simes, John; Goldstein, David

    2016-08-10

    We evaluated the activity of regorafenib, an oral multikinase inhibitor, in advanced gastric adenocarcinoma. We conducted an international (Australia and New Zealand, South Korea, and Canada) randomized phase II trial in which patients were randomly assigned at a two-to-one ratio and stratified by lines of prior chemotherapy for advanced disease (one v two) and region. Eligible patients received best supportive care plus regorafenib 160 mg or matching placebo orally on days 1 to 21 of each 28-day cycle until disease progression or prohibitive adverse events occurred. The primary end point was progression-free survival (PFS). Final analysis included data to December 31, 2014. A total of 152 patients were randomly assigned from November 7, 2012, to February 25, 2014, yielding 147 evaluable patients (regorafenib, n = 97; placebo, n = 50). Baseline characteristics were balanced. Median PFS significantly differed between groups (regorafenib, 2.6 months; 95% CI, 1.8 to 3.1 and placebo, 0.9 months; 95% CI, 0.9 to 0.9; hazard ratio [HR], 0.40; 95% CI, 0.28 to 0.59; P regorafenib was seen (median, 5.8 months; 95% CI, 4.4 to 6.8 v 4.5 months; 95% CI, 3.4 to 5.2; HR, 0.74; P = .147). Twenty-nine patients assigned to placebo received open-label regorafenib after disease progression. Regorafenib toxicity was similar to that previously reported. In this phase II trial, regorafenib was effective in prolonging PFS in refractory advanced gastric adenocarcinoma. Regional differences were found, but regorafenib was effective in both regional groups. A phase III trial is planned. © 2016 by American Society of Clinical Oncology.

  5. 3D Printing of Scaffold for Cells Delivery: Advances in Skin Tissue Engineering

    Directory of Open Access Journals (Sweden)

    Deepti Singh

    2016-01-01

    Full Text Available Injury or damage to tissue and organs is a major health problem, resulting in about half of the world’s annual healthcare expenditure every year. Advances in the fields of stem cells (SCs and biomaterials processing have provided a tremendous leap for researchers to manipulate the dynamics between these two, and obtain a skin substitute that can completely heal the wounded areas. Although wound healing needs a coordinated interplay between cells, extracellular proteins and growth factors, the most important players in this process are the endogenous SCs, which activate the repair cascade by recruiting cells from different sites. Extra cellular matrix (ECM proteins are activated by these SCs, which in turn aid in cellular migrations and finally secretion of growth factors that can seal and heal the wounds. The interaction between ECM proteins and SCs helps the skin to sustain the rigors of everyday activity, and in an attempt to attain this level of functionality in artificial three-dimensional (3D constructs, tissue engineered biomaterials are fabricated using more advanced techniques such as bioprinting and laser assisted printing of the organs. This review provides a concise summary of the most recent advances that have been made in the area of polymer bio-fabrication using 3D bio printing used for encapsulating stem cells for skin regeneration. The focus of this review is to describe, in detail, the role of 3D architecture and arrangement of cells within this system that can heal wounds and aid in skin regeneration.

  6. Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial

    Science.gov (United States)

    Sudore, Rebecca L; Barnes, Deborah E; Le, Gem M; Ramos, Roberto; Osua, Stacy J; Richardson, Sarah A; Boscardin, John; Schillinger, Dean

    2016-01-01

    Introduction Advance care planning (ACP) is a process that allows patients to identify their goals for medical care. Traditionally, ACP has focused on completing advance directives; however, we have expanded the ACP paradigm to also prepare patients to communicate their wishes and make informed decisions. To this end, we created an ACP website called PREPARE (http://www.prepareforyourcare.org) to prepare diverse English-speaking and Spanish-speaking older adults for medical decision-making. Here, we describe the study protocol for a randomised controlled efficacy trial of PREPARE in a safety-net setting. The goal is to determine the efficacy of PREPARE to engage diverse English-speaking and Spanish-speaking older adults in a full spectrum of ACP behaviours. Methods and analysis We include English-speaking and Spanish-speaking adults from an urban public hospital who are ≥55 years old, have ≥2 chronic medical conditions and have seen a primary care physician ≥2 times in the last year. Participants are randomised to the PREPARE intervention (review PREPARE and an easy-to-read advance directive) or the control arm (only the easy-to-read advance directive). The primary outcome is documentation of an advance directive and/or ACP discussion. Secondary outcomes include ACP behaviour change processes measured with validated surveys (eg, self-efficacy, readiness) and a broad range of ACP actions (eg, choosing a surrogate, identifying goals for care, discussing ACP with clinicians and/or surrogates). Using blinded outcome ascertainment, outcomes will be measured at 1 week and at 3, 6 and 12 months, and compared between study arms using mixed-effects logistic regression and mixed-effects linear, Poisson or negative binomial regression. Ethics and dissemination This study has been approved by the appropriate Institutional Review Boards and is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of this study will

  7. Effects of vitamin D supplementation on insulin resistance and cardiometabolic risk factors in children with metabolic syndrome: a triple-masked controlled trial

    Directory of Open Access Journals (Sweden)

    Roya Kelishadi

    2014-01-01

    Full Text Available OBJECTIVE: this triple-masked controlled trial aimed to assess the effects of vitamin D supplementation on insulin resistance and cardiometabolic risk factors in obese children and adolescents. METHODS: the study comprised 50 participants, aged 10 to16 years, who were randomly assigned into two groups of equal number. In this 12-week trial, one group received oral vitamin D (300,000 IU and the other group received placebo. Cardiometabolic risk factors, insulin resistance, and a continuous value of metabolic syndrome (cMetS were determined. Statistical analysis was conducted after adjustment for covariate interactions. RESULTS: overall, 21 patients in the vitamin D group and 22 in the placebo group completed the trial. No significant difference was observed in the baseline characteristics of the two groups. After the trial, in the vitamin D group, serum insulin and triglyceride concentrations, as well as HOM -IR and C-MetS decreased significantly, both when compared with the baseline and with the placebo group. No significant difference was observed when comparing total cholesterol, LDL-C, HDL-C, fasting blood glucose, and blood pressure. CONCLUSION: the present findings support the favorable effects of vitamin D supplementation on reducing insulin resistance and cardiometabolic risk factors in obese children.

  8. Vismodegib in patients with advanced basal cell carcinoma: Primary analysis of STEVIE, an international, open-label trial.

    Science.gov (United States)

    Basset-Séguin, N; Hauschild, A; Kunstfeld, R; Grob, J; Dréno, B; Mortier, L; Ascierto, P A; Licitra, L; Dutriaux, C; Thomas, L; Meyer, N; Guillot, B; Dummer, R; Arenberger, P; Fife, K; Raimundo, A; Dika, E; Dimier, N; Fittipaldo, A; Xynos, I; Hansson, J

    2017-11-01

    The SafeTy Events in VIsmodEgib study (STEVIE, ClinicalTrials.gov, NCT01367665), assessed safety and efficacy of vismodegib-a first-in-class Hedgehog pathway inhibitor demonstrating clinical benefit in advanced basal cell carcinoma (BCC)-in a patient population representative of clinical practice. Primary analysis data are presented. Patients with locally advanced or metastatic BCC received oral vismodegib 150 mg/d until progressive disease, unacceptable toxicity, or withdrawal. Primary objective was safety. Efficacy variables were assessed as secondary end-points. Evaluable adult patients (N = 1215, 1119 locally advanced; 96 metastatic BCC) from 36 countries were treated; 147 patients (12%) remained on study at time of reporting. Median (range) treatment duration was 8.6 (0-44) months. Most patients (98%) had ≥1 treatment-emergent adverse event (TEAE). The incidence of the most common TEAEs was consistent with reports in previous analyses. No association between creatine phosphokinase (CPK) abnormalities and muscle spasm was observed. Serious TEAEs occurred in 289 patients (23.8%). Exposure ≥12 months did not lead to increased incidence or severity of new TEAEs. The majority of the most common TEAEs ongoing at time of treatment discontinuation resolved by 12 months afterwards, regardless of Gorlin syndrome status. Response rates (investigator-assessed) in patients with histologically confirmed measurable baseline disease were 68.5% (95% confidence interval (CI) 65.7-71.3) in patients with locally advanced BCC and 36.9% (95% CI 26.6-48.1) in patients with metastatic BCC. The primary analysis of STEVIE demonstrates that vismodegib is tolerable in typical patients in clinical practice; safety profile is consistent with that in previous reports. Long-term exposure was not associated with worsening severity/frequency of TEAEs. Investigator-assessed response rates showed high rate of tumour control. CLINICALTRIALS.GOV: NCT01367665. Copyright © 2017 The Authors

  9. Adaptive radiotherapy for head and neck cancer—Dosimetric results from a prospective clinical trial

    International Nuclear Information System (INIS)

    Schwartz, David L.; Garden, Adam S.; Shah, Shalin J.; Chronowski, Gregory; Sejpal, Samir; Rosenthal, David I.; Chen, Yipei; Zhang, Yongbin; Zhang, Lifei; Wong, Pei-Fong; Garcia, John A.; Kian Ang, K.; Dong, Lei

    2013-01-01

    Purpose: To conduct a clinical trial evaluating adaptive head and neck radiotherapy (ART). Methods: Patients with locally advanced oropharyngeal cancer were prospectively enrolled. Daily CT-guided setup and deformable image registration permitted mapping of dose to avoidance structures and CTVs. We compared four planning scenarios: (1) original IMRT plan aligned daily to marked isocenter (BB); (2) original plan aligned daily to bone (IGRT); (3) IGRT with one adaptive replan (ART1); and (4) actual treatment received by each study patient (IGRT with one or two adaptive replans, ART2). Results: All 22 study patients underwent one replan (ART1); eight patients had two replans (ART2). ART1 reduced mean dose to contralateral parotid by 0.6 Gy or 2.8% (paired t-test; p = 0.003) and ipsilateral parotid by 1.3 Gy (3.9%) (p = 0.002) over the IGRT alone. ART2 further reduced the mean contralateral parotid dose by 0.8 Gy or 3.8% (p = 0.026) and ipsilateral parotid by 4.1 Gy or 9% (p = 0.001). ART significantly reduced integral body dose. Conclusions: This pilot trial suggests that head and neck ART dosimetrically outperforms IMRT. IGRT that leverages conventional PTV margins does not improve dosimetry. One properly timed replan delivers the majority of achievable dosimetric improvement. The clinical impact of ART must be confirmed by future trials

  10. 3D straight-stick laparoscopy versus 3D robotics for task performance in novice surgeons: a randomised crossover trial.

    Science.gov (United States)

    Shakir, Fevzi; Jan, Haider; Kent, Andrew

    2016-12-01

    The advent of three-dimensional passive stereoscopic imaging has led to the development of 3D laparoscopy. In simulation tasks, a reduction in error rate and performance time is seen with 3D compared to two-dimensional (2D) laparoscopy with both novice and expert surgeons. Robotics utilises 3D and instrument articulation through a console interface. Robotic trials have demonstrated that tasks performed in 3D produced fewer errors and quicker performance times compared with those in 2D. It was therefore perceived that the main advantage of robotic surgery was in fact 3D. Our aim was to compare 3D straight-stick laparoscopic task performance (3D) with robotic 3D (Robot), to determine whether robotic surgery confers additional benefit over and above 3D visualisation. We randomised 20 novice surgeons to perform four validated surgical tasks, either with straight-stick 3D laparoscopy followed by 3D robotic surgery or in the reverse order. The trial was conducted in two fully functional operating theatres. The primary outcome of the study was the error rate as defined for each task, and the secondary outcome was the time taken to complete each task. The participants were asked to perform the tasks as quickly and as accurately as possible. Data were analysed using SPSS version 21. The median error rate for completion of all four tasks with the robot was 2.75 and 5.25 for 3D with a P value performance time for completion of all four tasks with the robot was 157.1 and 342.5 s for 3D with a P value 3D robotic systems over 3D straight-stick laparoscopy, in terms of reduced error rate and quicker task performance time.

  11. Hip fracture risk in relation to vitamin D supplementation and serum 25-hydroxyvitamin D levels: a systematic review and meta-analysis of randomised controlled trials and observational studies

    Directory of Open Access Journals (Sweden)

    Roddam Andrew W

    2010-06-01

    Full Text Available Abstract Background Vitamin D supplementation for fracture prevention is widespread despite conflicting interpretation of relevant randomised controlled trial (RCT evidence. This study summarises quantitatively the current evidence from RCTs and observational studies regarding vitamin D, parathyroid hormone (PTH and hip fracture risk. Methods We undertook separate meta-analyses of RCTs examining vitamin D supplementation and hip fracture, and observational studies of serum vitamin D status (25-hydroxyvitamin D (25(OHD level, PTH and hip fracture. Results from RCTs were combined using the reported hazard ratios/relative risks (RR. Results from case-control studies were combined using the ratio of 25(OHD and PTH measurements of hip fracture cases compared with controls. Original published studies of vitamin D, PTH and hip fracture were identified through PubMed and Web of Science databases, searches of reference lists and forward citations of key papers. Results The seven eligible RCTs identified showed no significant difference in hip fracture risk in those randomised to cholecalciferol or ergocalciferol supplementation versus placebo/control (RR = 1.13[95%CI 0.98-1.29]; 801 cases, with no significant difference between trials of 21 (heterogeneity = 51.02, p 216 (heterogeneity = 137.9, p 29 (heterogeneity = 149.68, p Conclusions Neither higher nor lower dose vitamin D supplementation prevented hip fracture. Randomised and observational data on vitamin D and hip fracture appear to differ. The reason for this is unclear; one possible explanation is uncontrolled confounding in observational studies. Post-fracture PTH levels are unrelated to hip fracture risk.

  12. Clinical Trials

    Medline Plus

    Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...

  13. Recent results of a seismically isolated optical table prototype designed for advanced LIGO

    International Nuclear Information System (INIS)

    Sannibale, V; Abbott, B; Boschi, V; Coyne, D; DeSalvo, R; Aso, Y; Marka, S; Ottaway, D; Stochino, A

    2008-01-01

    The Horizontal Access Module Seismic Attenuation System (HAM-SAS) is a mechanical device expressly designed to isolate a multipurpose optical table and fit in the tight space of the LIGO HAM Ultra-High-Vacuum chamber. Seismic attenuation in the detectors' sensitivity frequency band is achieved with state of the art passive mechanical attenuators. These devices should provide an attenuation factor of about 70dB above 10Hz at the suspension point of the Advanced LIGO triple pendulum suspension. Automatic control techniques are used to position the optical table and damp rigid body modes. Here, we report the main results obtained from the full scale prototype installed at the MIT LIGO Advanced System Test Interferometer (LASTI) facility. Seismic attenuation performance, control strategies, improvements and limitations are also discussed

  14. The TrialsTracker: Automated ongoing monitoring of failure to share clinical trial results by all major companies and research institutions.

    Science.gov (United States)

    Powell-Smith, Anna; Goldacre, Ben

    2016-01-01

    Background : Failure to publish trial results is a prevalent ethical breach with a negative impact on patient care. Audit is an important tool for quality improvement. We set out to produce an online resource that automatically identifies the sponsors with the best and worst record for failing to share trial results. Methods: A tool was produced that identifies all completed trials from clinicaltrials.gov, searches for results in the clinicaltrials.gov registry and on PubMed, and presents summary statistics for each sponsor online. Results : The TrialsTracker tool is now available. Results are consistent with previous publication bias cohort studies using manual searches. The prevalence of missing studies is presented for various classes of sponsor. All code and data is shared. Discussion: We have designed, built, and launched an easily accessible online service, the TrialsTracker, that identifies sponsors who have failed in their duty to make results of clinical trials available, and which can be maintained at low cost. Sponsors who wish to improve their performance metrics in this tool can do so by publishing the results of their trials.

  15. Advances in integrated plasma control on DIII-D

    International Nuclear Information System (INIS)

    Walker, M.L.; Ferron, J.R.; Hahn, S.H.; Humphreys, D.A.; In, Y.; Johnson, R.D.; Kim, J.S.; La Haye, R.J.; Leuer, J.A.; Penaflor, B.G.; Welander, A.S.; Xiao, B.

    2007-01-01

    The DIII-D advanced tokamak physics program requires extremely high performance from the DIII-D plasma control system, including simultaneous accurate regulation of plasma shape, stored energy, density and divertor characteristics, as well as coordinated suppression of magnetohydrodynamic instabilities. To satisfy these demanding control requirements, we apply the integrated plasma control method, consisting of construction of physics-based plasma and system response models, validation of models against operating experiments, design of integrated controllers that operate in concert with one another, simulation of control action against off-line and actual machine control platforms, and optimization through iteration of the design-test loop. The present work describes progress in development of physics models and development and experimental application of new model-based plasma controllers on DIII-D. We also describe the development of the control software, hardware, and model-based control algorithms for the superconducting EAST and KSTAR tokamaks

  16. Phase I clinical trial of fibronectin CH296-stimulated T cell therapy in patients with advanced cancer.

    Directory of Open Access Journals (Sweden)

    Takeshi Ishikawa

    Full Text Available BACKGROUND: Previous studies have demonstrated that less-differentiated T cells are ideal for adoptive T cell transfer therapy (ACT and that fibronectin CH296 (FN-CH296 together with anti-CD3 resulted in cultured cells that contain higher amounts of less-differentiated T cells. In this phase I clinical trial, we build on these prior results by assessing the safety and efficacy of FN-CH296 stimulated T cell therapy in patients with advanced cancer. METHODS: Patients underwent fibronectin CH296-stimulated T cell therapy up to six times every two weeks and the safety and antitumor activity of the ACT were assessed. In order to determine immune function, whole blood cytokine levels and the number of peripheral regulatory T cells were analyzed prior to ACT and during the follow up. RESULTS: Transferred cells contained numerous less-differentiated T cells greatly represented by CD27+CD45RA+ or CD28+CD45RA+ cell, which accounted for approximately 65% and 70% of the total, respectively. No ACT related severe or unexpected toxicities were observed. The response rate among patients was 22.2% and the disease control rate was 66.7%. CONCLUSIONS: The results obtained in this phase I trial, indicate that FN-CH296 stimulated T cell therapy was very well tolerated with a level of efficacy that is quite promising. We also surmise that expanding T cell using CH296 is a method that can be applied to other T- cell-based therapies. TRIAL REGISTRATION: UMIN UMIN000001835.

  17. A cross-validation trial of an Internet-based prevention program for alcohol and cannabis: Preliminary results from a cluster randomised controlled trial.

    Science.gov (United States)

    Champion, Katrina E; Newton, Nicola C; Stapinski, Lexine; Slade, Tim; Barrett, Emma L; Teesson, Maree

    2016-01-01

    Replication is an important step in evaluating evidence-based preventive interventions and is crucial for establishing the generalizability and wider impact of a program. Despite this, few replications have occurred in the prevention science field. This study aims to fill this gap by conducting a cross-validation trial of the Climate Schools: Alcohol and Cannabis course, an Internet-based prevention program, among a new cohort of Australian students. A cluster randomized controlled trial was conducted among 1103 students (Mage: 13.25 years) from 13 schools in Australia in 2012. Six schools received the Climate Schools course and 7 schools were randomized to a control group (health education as usual). All students completed a self-report survey at baseline and immediately post-intervention. Mixed-effects regressions were conducted for all outcome variables. Outcomes assessed included alcohol and cannabis use, knowledge and intentions to use these substances. Compared to the control group, immediately post-intervention the intervention group reported significantly greater alcohol (d = 0.67) and cannabis knowledge (d = 0.72), were less likely to have consumed any alcohol (even a sip or taste) in the past 6 months (odds ratio = 0.69) and were less likely to intend on using alcohol in the future (odds ratio = 0.62). However, there were no effects for binge drinking, cannabis use or intentions to use cannabis. These preliminary results provide some support for the Internet-based Climate Schools: Alcohol and Cannabis course as a feasible way of delivering alcohol and cannabis prevention. Intervention effects for alcohol and cannabis knowledge were consistent with results from the original trial; however, analyses of longer-term follow-up data are needed to provide a clearer indication of the efficacy of the intervention, particularly in relation to behavioral changes. © The Royal Australian and New Zealand College of Psychiatrists 2015.

  18. Weight changes and their predictors amongst 11 140 patients with type 2 diabetes in the ADVANCE trial.

    NARCIS (Netherlands)

    Dieren, S. van; Czernichow, S.; Chalmers, J.; Kengne, A.P.; Galan, B.E. de; Poulter, N.; Woodward, M.; Beulens, J.W.; Grobbee, D.E.; Schouw, Y.T. van der; Zoungas, S.

    2012-01-01

    AIMS: To determine the baseline characteristics and glucose-lowering therapies associated with weight change among patients with type 2 diabetes. METHODS: Eleven thousand one hundred and forty participants in the ADVANCE trial were randomly assigned to an intensive [aiming for a haemoglobin A1c

  19. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma

    NARCIS (Netherlands)

    Ribas, Antoni; Kefford, Richard; Marshall, Margaret A.; Punt, Cornelis J. A.; Haanen, John B.; Marmol, Maribel; Garbe, Claus; Gogas, Helen; Schachter, Jacob; Linette, Gerald; Lorigan, Paul; Kendra, Kari L.; Maio, Michele; Trefzer, Uwe; Smylie, Michael; McArthur, Grant A.; Dreno, Brigitte; Nathan, Paul D.; Mackiewicz, Jacek; Kirkwood, John M.; Gomez-Navarro, Jesus; Huang, Bo; Pavlov, Dmitri; Hauschild, Axel

    2013-01-01

    In phase I/II trials, the cytotoxic T lymphocyte-associated antigen-4-blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with

  20. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma.

    NARCIS (Netherlands)

    Ribas, A.; Kefford, R.; Marshall, Martin; Punt, C.J.A.; Haanen, J.B.; Marmol, M.; Garbe, C.; Gogas, H.; Schachter, J.; Linette, G.; Lorigan, P.; Kendra, K.L.; Maio, M.; Trefzer, U.; Smylie, M.; McArthur, G.A.; Dreno, B.; Nathan, P.D.; Mackiewicz, J.; Kirkwood, J.M.; Gomez-Navarro, J.; Huang, B.; Pavlov, D.; Hauschild, A.

    2013-01-01

    PURPOSE: In phase I/II trials, the cytotoxic T lymphocyte-associated antigen-4-blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients

  1. Randomized controlled trial of vitamin D supplementation in children with autism spectrum disorder.

    Science.gov (United States)

    Saad, Khaled; Abdel-Rahman, Ahmed A; Elserogy, Yasser M; Al-Atram, Abdulrahman A; El-Houfey, Amira A; Othman, Hisham A-K; Bjørklund, Geir; Jia, Feiyong; Urbina, Mauricio A; Abo-Elela, Mohamed Gamil M; Ahmad, Faisal-Alkhateeb; Abd El-Baseer, Khaled A; Ahmed, Ahmed E; Abdel-Salam, Ahmad M

    2018-01-01

    Autism spectrum disorder (ASD) is a frequent developmental disorder characterized by pervasive deficits in social interaction, impairment in verbal and nonverbal communication, and stereotyped patterns of interests and activities. It has been previously reported that there is vitamin D deficiency in autistic children; however, there is a lack of randomized controlled trials of vitamin D supplementation in ASD children. This study is a double-blinded, randomized clinical trial (RCT) that was conducted on 109 children with ASD (85 boys and 24 girls; aged 3-10 years). The aim of this study was to assess the effects of vitamin D supplementation on the core symptoms of autism in children. ASD patients were randomized to receive vitamin D3 or placebo for 4 months. The serum levels of 25-hydroxycholecalciferol (25 (OH)D) were measured at the beginning and at the end of the study. The autism severity and social maturity of the children were assessed by the Childhood Autism Rating Scale (CARS), Aberrant Behavior Checklist (ABC), Social Responsiveness Scale (SRS), and the Autism Treatment Evaluation Checklist (ATEC). UMIN-CTR Study Design: trial number: UMIN000020281. Supplementation of vitamin D was well tolerated by the ASD children. The daily doses used in the therapy group was 300 IU vitamin D3/kg/day, not to exceed 5,000 IU/day. The autism symptoms of the children improved significantly, following 4-month vitamin D3 supplementation, but not in the placebo group. This study demonstrates the efficacy and tolerability of high doses of vitamin D3 in children with ASD. This study is the first double-blinded RCT proving the efficacy of vitamin D3 in ASD patients. Depending on the parameters measured in the study, oral vitamin D supplementation may safely improve signs and symptoms of ASD and could be recommended for children with ASD. At this stage, this study is a single RCT with a small number of patients, and a great deal of additional wide-scale studies are needed to

  2. Effect of Amifostine on Response Rates in Locally Advanced Non-Small-Cell Lung Cancer Patients Treated on Randomized Controlled Trials: A Meta-Analysis

    International Nuclear Information System (INIS)

    Mell, Loren K.; Malik, Renuka; Komaki, Ritsuko; Movsas, Benjamin; Swann, R. Suzanne; Langer, Corey; Antonadou, Dosia; Koukourakis, Michael; Mundt, Arno J.

    2007-01-01

    Purpose: Amifostine can reduce the cytotoxic effects of chemotherapy and radiotherapy in patients with locally advanced non-small-cell lung cancer, but concerns remain regarding its possible tumor-protective effects. Studies with sufficient statistical power to address this question are lacking. Methods and Materials: We performed a meta-analysis of all published clinical trials involving locally advanced non-small-cell lung cancer patients treated with radiotherapy with or without chemotherapy, who had been randomized to treatment with amifostine vs. no amifostine or placebo. Random effects estimates of the relative risk of overall, partial, and complete response were obtained. Results: Seven randomized trials involving 601 patients were identified. Response rate data were available for six studies (552 patients). The pooled relative risk (RR) estimate was 1.07 (95% confidence interval, 0.97-1.18; p = 0.18), 1.21 (95% confidence interval, 0.83-1.78; p = 0.33), and 0.99 (95% confidence interval, 0.78-1.26; p = 0.95) for overall, complete, and partial response, respectively (a RR >1 indicates improvement in response with amifostine compared with the control arm). The results were similar after sensitivity analyses. No evidence was found of treatment effect heterogeneity across the studies. Conclusions: Amifostine has no effect on tumor response in patients with locally advanced non-small-cell lung cancer treated with radiotherapy with or without chemotherapy

  3. Advances and Best Practices in Airborne Gravimetry from the U.S. GRAV-D Project

    Science.gov (United States)

    Diehl, Theresa; Childers, Vicki; Preaux, Sandra; Holmes, Simon; Weil, Carly

    2013-04-01

    The Gravity for the Redefinition of the American Vertical Datum (GRAV-D) project, an official policy of the U.S. National Geodetic Survey as of 2007, is working to survey the entire U.S. and its holdings with high-altitude airborne gravimetry. The goal of the project is to provide a consistent, high-quality gravity dataset that will become the cornerstone of a new gravimetric geoid and national vertical datum in 2022. Over the last five years, the GRAV-D project has surveyed more than 25% of the country, accomplishing almost 500 flights on six different aircraft platforms and producing more than 3.7 Million square km of data thus far. This wealth of experience has led to advances in the collection, processing, and evaluation of high-altitude (20,000 - 35,000 ft) airborne gravity data. This presentation will highlight the most important practical and theoretical advances of the GRAV-D project, giving an introduction to each. Examples of innovation include: 1. Use of navigation grade inertial measurement unit data and precise lever arm measurements for positioning; 2. New quality control tests and software for near real-time analysis of data in the field; 3. Increased accuracy of gravity post-processing by reexamining assumptions and simplifications that were inconsistent with a goal of 1 mGal precision; and 4. Better final data evaluation through crossovers, additional statistics, and inclusion of airborne data into harmonic models that use EGM08 as a base model. The increases in data quality that resulted from implementation of the above advances (and others) will be shown with a case study of the GRAV-D 2008 southern Alaska survey near Anchorage, over Cook Inlet. The case study's statistics and comparisons to global models illustrate the impact that these advances have had on the final airborne gravity data quality. Finally, the presentation will summarize the best practices identified by the project from its last five years of experience.

  4. Prenatal vitamin d supplementation and child respiratory health: a randomised controlled trial.

    Science.gov (United States)

    Goldring, Stephen T; Griffiths, Chris J; Martineau, Adrian R; Robinson, Stephen; Yu, Christina; Poulton, Sheree; Kirkby, Jane C; Stocks, Janet; Hooper, Richard; Shaheen, Seif O; Warner, John O; Boyle, Robert J

    2013-01-01

    Observational studies suggest high prenatal vitamin D intake may be associated with reduced childhood wheezing. We examined the effect of prenatal vitamin D on childhood wheezing in an interventional study. We randomised 180 pregnant women at 27 weeks gestation to either no vitamin D, 800 IU ergocalciferol daily until delivery or single oral bolus of 200,000 IU cholecalciferol, in an ethnically stratified, randomised controlled trial. Supplementation improved but did not optimise vitamin D status. Researchers blind to allocation assessed offspring at 3 years. Primary outcome was any history of wheeze assessed by validated questionnaire. Secondary outcomes included atopy, respiratory infection, impulse oscillometry and exhaled nitric oxide. Primary analyses used logistic and linear regression. We evaluated 158 of 180 (88%) offspring at age 3 years for the primary outcome. Atopy was assessed by skin test for 95 children (53%), serum IgE for 86 (48%), exhaled nitric oxide for 62 (34%) and impulse oscillometry of acceptable quality for 51 (28%). We found no difference between supplemented and control groups in risk of wheeze [no vitamin D: 14/50 (28%); any vitamin D: 26/108 (24%) (risk ratio 0.86; 95% confidence interval 0.49, 1.50; P = 0.69)]. There was no significant difference in atopy, eczema risk, lung function or exhaled nitric oxide between supplemented groups and controls. Prenatal vitamin D supplementation in late pregnancy that had a modest effect on cord blood vitamin D level, was not associated with decreased wheezing in offspring at age three years. Controlled-Trials.com ISRCTN68645785.

  5. Developing novel 3D antennas using advanced additive manufacturing technology

    Science.gov (United States)

    Mirzaee, Milad

    In today's world of wireless communication systems, antenna engineering is rapidly advancing as the wireless services continue to expand in support of emerging commercial applications. Antennas play a key role in the performance of advanced transceiver systems where they serve to convert electric power to electromagnetic waves and vice versa. Researchers have held significant interest in developing this crucial component for wireless communication systems by employing a variety of design techniques. In the past few years, demands for electrically small antennas continues to increase, particularly among portable and mobile wireless devices, medical electronics and aerospace systems. This trend toward smaller electronic devices makes the three dimensional (3D) antennas very appealing, since they can be designed in a way to use every available space inside the devise. Additive Manufacturing (AM) method could help to find great solutions for the antennas design for next generation of wireless communication systems. In this thesis, the design and fabrication of 3D printed antennas using AM technology is studied. To demonstrate this application of AM, different types of antennas structures have been designed and fabricated using various manufacturing processes. This thesis studies, for the first time, embedded conductive 3D printed antennas using PolyLactic Acid (PLA) and Acrylonitrile Butadiene Styrene (ABS) for substrate parts and high temperature carbon paste for conductive parts which can be a good candidate to overcome the limitations of direct printing on 3D surfaces that is the most popular method to fabricate conductive parts of the antennas. This thesis also studies, for the first time, the fabrication of antennas with 3D printed conductive parts which can contribute to the new generation of 3D printed antennas.

  6. Effect of vitamin D replacement on maternal and neonatal outcomes: a randomised controlled trial in pregnant women with hypovitaminosis D. A protocol.

    Science.gov (United States)

    Chakhtoura, M; Nassar, A; Arabi, A; Cooper, C; Harvey, N; Mahfoud, Z; Nabulsi, M; El-Hajj Fuleihan, G

    2016-03-08

    The vitamin D recommended doses during pregnancy differ between societies. The WHO guidelines do not recommend routine prenatal supplementation, but they underscore the fact that women with the lowest levels may benefit most. The effects of routine supplementation during pregnancy on maternal and neonatal clinical outcomes have not been investigated in the Middle East, where hypovitaminosis D is prevalent. Our hypothesis is that in Middle Eastern pregnant women, a vitamin D dose of 3000 IU/day is required to reach a desirable maternal 25-hydroxyvitamin D [25(OH)D] level, and to positively impact infant bone mineral content (BMC). This is a multicentre blinded randomised controlled trial. Pregnant women presenting to the Obstetrics and Gynaecology clinics will be approached. Eligible women will be randomised to daily equivalent doses of cholecalciferol, 600 IU or 3000 IU, from 15 to 18 weeks gestation until delivery. Maternal 25(OH)D and chemistries will be assessed at study entry, during the third trimester and at delivery. Neonatal anthropometric variables and 25(OH)D level will be measured at birth, and bone and fat mass assessment by dual-energy X-ray absorptiometry scan at 1 month. A sample size of 280 pregnant women is needed to demonstrate a statistically significant difference in the proportion of women reaching a 25(OH)D level ≥ 50 nmol/L at delivery, and a difference in infant BMC of 6 (10)g, for a 90% power and a 2.5% level of significance. The proportions of women achieving a target 25(OH)D level will be compared between the two arms, using χ(2). An independent t test will be used to compare mean infant BMC between the two arms. The primary analysis is an intention-to-treat analysis of unadjusted results. The protocol has been approved by the Institutional Review Board at the American University of Beirut-Lebanon (IM.GEHF.22). The trial results will be published in peer-reviewed medical journals and presented at scientific conferences. NCT02434380

  7. True fir spacing trials: 10-year results.

    Science.gov (United States)

    Robert O. Curtis

    2008-01-01

    Eighteen precommercial thinning trials were established in true fir-hemlock stands in the Olympic Mountains and the west side of the Cascade Range during the period 1987 through 1994. This paper updates a previous report, with results for the first 10 years after establishment. Results are given for (1) all trees, (2) the largest 80 per acre of any species, and (3)...

  8. Disseminating results to clinical trial participants: a qualitative review of patient understanding in a post-trial population.

    Science.gov (United States)

    Darbyshire, Julie Lorraine; Price, Hermione Clare

    2012-01-01

    To identify the most appropriate format for results dissemination to maximise understanding of trial results. Qualitative. Of the original 58 4-T trial centres, 34 agreed to take part in this ancillary research. All participants from these centres were eligible. All 343 participants were sent questionnaires. The low response rate meant that we were unable to make any firm conclusions about the patients' preferred method of dissemination; however, we were able to comment on the level of understanding demonstrated by the trial participants. All 40 (12%) returned questionnaires were received from 15 centres. We received no questionnaires from over half of the centres. The questionnaires which were returned demonstrated broad satisfaction with the results letter, general enthusiasm for the trial and a variable level of understanding of the results; however, there was a high proportion of responders who were not clear on why the research was undertaken or what the results meant. The low response rate may be related to delays during the trial set-up process suggesting that interest in a study quickly wanes for both patients and centres. From this we deduce that rapid dissemination of results is needed if it is to have any impact at all. The responders are likely to reflect a biased cohort who were both enthusiastic about the research and who had a good experience during their 3 years in the 4-T trial. It is perhaps not surprising therefore that the overview is positive. That this population was still not fully informed about the purpose of the research would seem to confirm a low level of understanding among the general public which we suggest should be addressed during the consent process.

  9. Efficacy and safety outcomes in vitamin D supplement users in the fingolimod phase 3 trials.

    Science.gov (United States)

    Hongell, Kira; Silva, Diego G; Ritter, Shannon; Meier, Daniela Piani; Soilu-Hänninen, Merja

    2018-02-01

    Low serum levels of 25-hydroxyvitamin D have been associated with worse outcomes in multiple sclerosis (MS) patients treated with interferon-beta. Association of vitamin D nutrition on the outcomes of other MS therapies has been studied less. Whether patients in the phase 3 fingolimod trials using vitamin D supplements have better clinical, MRI and safety outcomes than non-users. Pooled data from phase 3 FREEDOMS trials was analyzed post hoc. Vitamin D use was defined as 'non-users' (n = 562), 'casual users' (n = 157) and 'daily users' (usage 100% time in the study, n = 110). Expanded Disability Status Scale change from baseline to month 24, and annual relapse rate and proportion of patients with relapses were similar across the vitamin D user groups. Proportion of patients free of new/enlarging T2 lesions significantly favored vitamin D 'daily users' versus 'non-users'. Mean number of lesions were lower and proportion of patients free of gadolinium-enhanced T1-lesions were higher in the 'daily users'. At month 12, percent brain volume change was significantly lower in the 'daily users' versus 'non-users' and remained low at month 24 (non-significant). Incidence of depression was lower for vitamin D 'daily users' (non-significant). We observed improved MRI outcomes on percent brain volume change and proportion of patients free of new/enlarging T2 lesions, and a trend of less depression in the 'daily users' of vitamin D supplement in patients in the FREEDOMS trials.

  10. Physiotherapy programme reduces fatigue in patients with advanced cancer receiving palliative care: randomized controlled trial.

    Science.gov (United States)

    Pyszora, Anna; Budzyński, Jacek; Wójcik, Agnieszka; Prokop, Anna; Krajnik, Małgorzata

    2017-09-01

    Cancer-related fatigue (CRF) is a common and relevant symptom in patients with advanced cancer that significantly decreases their quality of life. The aim of this study was to evaluate the effect of a physiotherapy programme on CRF and other symptoms in patients diagnosed with advanced cancer. The study was designed as a randomized controlled trial. Sixty patients diagnosed with advanced cancer receiving palliative care were randomized into two groups: the treatment group (n = 30) and the control group (n = 30). The therapy took place three times a week for 2 weeks. The 30-min physiotherapy session included active exercises, myofascial release and proprioceptive neuromuscular facilitation (PNF) techniques. The control group did not exercise. The outcomes included Brief Fatigue Inventory (BFI), Edmonton Symptom Assessment Scale (ESAS) and satisfaction scores. The exercise programme caused a significant reduction in fatigue scores (BFI) in terms of severity of fatigue and its impact on daily functioning. In the control group, no significant changes in the BFI were observed. Moreover, the physiotherapy programme improved patients' general well-being and reduced the intensity of coexisting symptoms such as pain, drowsiness, lack of appetite and depression. The analysis of satisfaction scores showed that it was also positively evaluated by patients. The physiotherapy programme, which included active exercises, myofascial release and PNF techniques, had beneficial effects on CRF and other symptoms in patients with advanced cancer who received palliative care. The results of the study suggest that physiotherapy is a safe and effective method of CRF management.

  11. High dose melphalan in the treatment of advanced neuroblastoma: results of a randomised trial (ENSG-1) by the European Neuroblastoma Study Group.

    Science.gov (United States)

    Pritchard, Jon; Cotterill, Simon J; Germond, Shirley M; Imeson, John; de Kraker, Jan; Jones, David R

    2005-04-01

    High dose myeloablative chemotherapy ("megatherapy"), with haematopoietic stem cell support, is now widely used to consolidate response to induction chemotherapy in patients with advanced neuroblastoma. In this study (European Neuroblastoma Study Group, ENSG1), the value of melphalan myeloablative "megatherapy" was evaluated in a randomised, multi-centre trial. Between 1982 and 1985, 167 children with stages IV and III neuroblastoma (123 stage IV > 1 year old at diagnosis and 44 stage III and stage IV from 6 to 12 months old at diagnosis) were treated with oncovin, cisplatin, epipodophyllotoxin, and cyclophosphamide (OPEC) induction chemotherapy every 3 weeks. After surgical excision of primary tumour, the 90 patients (69% of the total) who achieved complete response (CR) or good partial response (GPR) were eligible for randomisation either to high dose melphalan (180 mg per square meter) with autologous bone marrow support or to no further treatment. Sixty-five (72%) of eligible children were actually randomised and 21 of these patients were surviving at time of this analysis, with median follow-up from randomisation of 14.3 years. Five year event-free survival (EFS) was 38% (95% confidence interval (CI) 21-54%) in the melphalan-treated group and 27% (95% CI 12-42%) in the "no-melphalan" group. This difference was not statistically significant (P = 0.08, log rank test) but for the 48 randomised stage IV patients aged >1 year at diagnosis outcome was significantly better in the melphalan-treated group-5 year EFS 33% versus 17% (P = 0.01, log rank test). In this trial, high dose melphalan improved the length of EFS and overall survival of children with stage IV neuroblastoma >1 year of age who achieved CR or GPR after OPEC induction therapy and surgery. Multi-agent myeloablative regimens are now widely used as consolidation therapy for children with stage IV disease and in those with other disease stages when the MYCN gene copy number in tumour cells is amplified

  12. Vitamin D Supplementation in Elderly Black Women Does Not Prevent Bone Loss, a Randomized Controlled Trial.

    Science.gov (United States)

    Aloia, John F; Fazzari, Melissa; Islam, Shahidul; Mikhail, Mageda; Katumuluwa, Subhashini; Dhaliwal, Ruban; Stolberg, Alexandra; Usera, Gianina; Ragolia, Louis

    2018-06-15

    Black Americans have lower levels of serum 25(OH)D but superior bone health compared to white Americans. There is controversy over whether they should be screened for vitamin D deficiency and have higher vitamin D requirements than recommended by the Institute of Medicine (IOM). The purpose of this trial was to determine whether Vitamin D supplementation in elderly black women prevents bone loss. 260 healthy black American women, 60 years of age and older were recruited to take part in a two arm, double-dummy 3 year RCT of vitamin D 3 vs. placebo. The study was conducted in an ambulatory clinical research center. Vitamin D 3 dose was adjusted to maintain serum 25(OH)D above 75 nmol/L. Bone mineral density (BMD) and serum were measured for [parathyroid hormone (PTH), C-terminal crosslink telopeptide (CTX) and bone specific alkaline phosphatase (BSAP) every 6 months. Baseline serum 25(OH)D 3 was 54.8 ± 16.8 nmol/L. There was no group xtime interaction effect for any BMD measurement. For all BMD measurements, except for total body and spine, there was a statistically significant negative effect of time (P D above 75 nmol/L is comparable to the rate of loss with serum 25(OH)D at the RDA of 50 nmol/L. Black Americans should have the same exposure to vitamin D as white Americans. The trial was registered at clinical trials.gov: NCT01153568. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  13. A prospective evaluation of the impact of 18-F-fluoro-deoxy-D-glucose positron emission tomography staging on survival for patients with locally advanced esophageal cancer

    International Nuclear Information System (INIS)

    Blackstock, A. William; Farmer, Michael R.; Lovato, James; Mishra, Girish; Melin, Susan A.; Oaks, Timothy; Aklilu, Mabea; Clark, Paige B.; Levine, Edward A.

    2006-01-01

    Purpose: To determine the impact of 18-F-fluoro-deoxy-D-glucose positron emission tomography (FDG-PET) in the staging and prognosis of patients with locally advanced esophageal cancer (LAEC). Methods and Materials: Between January 2000 and October 2004, all patients with LAEC evaluated in the Department of Radiation Oncology were considered for enrollment into a Phase II trial of preoperative chemoradiation. Entry required a staging whole-body FDG-PET scan. Results: One hundred ten consecutive patients were evaluated; 38 were ineligible for reasons including treatment elsewhere, prior malignancy, or refusal of treatment. After conventional staging (clinical examination, endoscopic ultrasound, and chest/abdominal computerized tomography), 33 patients were ineligible because of metastatic disease or poor performance status. Of the remaining 39 patients, 23 were confirmed to have LAEC after FDG-PET staging and were treated in the Phase II trial (Cohort I). Sixteen patients, however, had FDG-PET findings consistent with occult metastatic disease and were deemed ineligible for the trial but were treated with curative intent (Cohort II). The 2-year survival rate for the 23 patients in Cohort I was 64%, compared with 17% (p = 0.003) for patients in Cohort II (FDG-PET positive). Conclusions: More than one-third of patients determined to have LAEC with conventional staging were upstaged with the use of FDG-PET. Despite comparable therapy, upstaging with FDG-PET predicts poor 2-year survival

  14. Recent DIII-D results

    International Nuclear Information System (INIS)

    Petersen, P.I.

    1994-07-01

    This paper summarizes the recent DIII-D experimental results and the development of the relevant hardware systems. The DIII-D program focuses on divertor solutions for next generation tokamaks such as International Thermo-nuclear Experimental Reactor (ITER) and Tokamak Physics Experiment (TPX), and on developing configurations with enhanced confinement and stability properties that will lead to a more compact and economical fusion reactor. The DIII-D program carries out this research in an integrated fashion

  15. A phase III trial of zoladex and flutamide versus orchiectomy in the treatment of patients with advanced carcinoma of the prostate

    DEFF Research Database (Denmark)

    Iversen, P; Christensen, M G; Friis, E

    1990-01-01

    In a multicenter Phase III trial 264 patients with advanced prostatic cancer were randomized to either bilateral orchiectomy or treatment with zoladex supplemented by flutamide. Presently, median follow-up time is 30 months. A small difference in objective response was recorded in favor of the co......In a multicenter Phase III trial 264 patients with advanced prostatic cancer were randomized to either bilateral orchiectomy or treatment with zoladex supplemented by flutamide. Presently, median follow-up time is 30 months. A small difference in objective response was recorded in favor...... of the combination therapy, whereas no statistically significant difference was found in subjective response to therapy, time to progression, and overall survival. Adverse effects were more commonly encountered in the pharmacologically treated patients. It is concluded that the combination of zoladex plus flutamide...... is not clinically superior to orchiectomy in the treatment of patients with advanced carcinoma of the prostate....

  16. Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study.

    Science.gov (United States)

    Sanders, Kerrie M; Stuart, Amanda L; Merriman, Elizabeth N; Read, Meaghan L; Kotowicz, Mark A; Young, Doris; Taylor, Roderick; Blair-Holt, Ian; Mander, Alistair G; Nicholson, Geoffrey C

    2009-11-25

    Randomised, placebo-controlled trials are needed to provide evidence demonstrating safe, effective interventions that reduce falls and fractures in the elderly. The quality of a clinical trial is dependent on successful recruitment of the target participant group. This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration. The characteristics of study participants at baseline are also described for this study. The Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol) or placebo every autumn for five consecutive years. A variety of recruitment strategies were employed to attract potential participants. Of the 2,317 participants randomised onto the study, 74% (n = 1716/2317) were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the 18 months of recruiting. A total of 70% of all participants were recruited as a result of targeted mail-out. The response rate from the letters increased from 2 to 7% following revision of the material by a public relations company. Participant demographic or risk factor profile did not differ between those recruited by targeted mail-outs compared with other methods. The most successful recruitment strategy was the targeted mail-out and the response rate was no higher in the local region where the study had extensive exposure through other recruiting strategies. The strategies that were labour-intensive and did not result in successful recruitment include the activities directed towards the GP medical centres. Comprehensive recruitment programs employ overlapping strategies

  17. Daily supplementation with 15 μg vitamin D2 compared with vitamin D3 to increase wintertime 25-hydroxyvitamin D status in healthy South Asian and white European women: a 12-wk randomized, placebo-controlled food-fortification trial.

    Science.gov (United States)

    Tripkovic, Laura; Wilson, Louise R; Hart, Kathryn; Johnsen, Sig; de Lusignan, Simon; Smith, Colin P; Bucca, Giselda; Penson, Simon; Chope, Gemma; Elliott, Ruan; Hyppönen, Elina; Berry, Jacqueline L; Lanham-New, Susan A

    2017-08-01

    Background: There are conflicting views in the literature as to whether vitamin D 2 and vitamin D 3 are equally effective in increasing and maintaining serum concentrations of 25-hydroxyvitamin D [25(OH)D], particularly at lower doses of vitamin D. Objective: We aimed to investigate whether vitamin D 2 or vitamin D 3 fortified in juice or food, at a relatively low dose of 15 μg/d, was effective in increasing serum total 25(OH)D and to compare their respective efficacy in South Asian and white European women over the winter months within the setting of a large randomized controlled trial. Design: A randomized, double-blind, placebo-controlled food-fortification trial was conducted in healthy South Asian and white European women aged 20-64 y ( n = 335; Surrey, United Kingdom) who consumed placebo, juice supplemented with 15 μg vitamin D 2 , biscuit supplemented with 15 μg vitamin D 2 , juice supplemented with 15 μg vitamin D 3 , or biscuit supplemented with 15 μg vitamin D 3 daily for 12 wk. Serum 25(OH)D was measured by liquid chromatography-tandem mass spectrometry at baseline and at weeks 6 and 12 of the study. Results: Postintervention in the 2 ethnic groups combined, both the vitamin D 3 biscuit and the vitamin D 3 juice groups showed a significantly greater absolute incremental change (Δ) in total 25(OH)D when compared with the vitamin D 2 biscuit group [Δ (95% CI): 15.3 nmol/L (7.4, 23.3 nmol/L) ( P < 0.0003) and 16.0 nmol/L (8.0, 23.9 nmol/L) ( P < 0.0001)], the vitamin D 2 juice group [Δ (95% CI): 16.3 nmol/L (8.4, 24.2 nmol/L) ( P < 0.0001) and 16.9 nmol/L (9.0, 24.8 nmol/L) ( P < 0.0001)], and the placebo group [Δ (95% CI): 42.3 nmol/L (34.4, 50.2 nmol/L) ( P < 0.0001) and 42.9 nmol/L (35.0, 50.8 nmol/L) ( P < 0.0002)]. Conclusions: With the use of a daily dose of vitamin D relevant to public health recommendations (15 μg) and in vehicles relevant to food-fortification strategies, vitamin D 3 was more effective than vitamin D 2 in increasing

  18. Irradiation with misonidazole and hyperbaric oxygen: final report on a randomized trial in advanced head and neck cancer

    International Nuclear Information System (INIS)

    Sealy, R.; Cridland, S.; Barry, L.; Norris, R.

    1986-01-01

    One hundred and thirty patients with locally advanced squamous carcinoma of the head and neck were treated in a prospective randomized trial to compare conventional irradiation (63.00 Gy in 30 fractions) with a combination sensitizer regimen of misonidazole and hyperbaric oxygen. The drug (2.0 gm/m2) was given with each of six fractions of 6.0 Gy in hyperbaric oxygen at 3 ATA. The results support a previous study and favor the combination at 1 year at better than the 10% level. This regimen could be useful for bulky primary or nodal disease

  19. KRAS Mutation Status and Clinical Outcome of Preoperative Chemoradiation With Cetuximab in Locally Advanced Rectal Cancer: A Pooled Analysis of 2 Phase II Trials

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Sun Young; Shim, Eun Kyung [Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of); Yeo, Hyun Yang [Division of Translational and Clinical Research I, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of); Baek, Ji Yeon [Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of); Hong, Yong Sang [Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Kim, Dae Yong [Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of); Division of Translational and Clinical Research I, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of); Kim, Tae Won [Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Kim, Jee Hyun [Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam (Korea, Republic of); Im, Seock-Ah [Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul (Korea, Republic of); Jung, Kyung Hae [Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul (Korea, Republic of); Chang, Hee Jin, E-mail: heejincmd@yahoo.com [Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of); Division of Translational and Clinical Research I, Research Institute and Hospital, National Cancer Center, Goyang (Korea, Republic of)

    2013-01-01

    Purpose: Cetuximab-containing chemotherapy is known to be effective for KRAS wild-type metastatic colorectal cancer; however, it is not clear whether cetuximab-based preoperative chemoradiation confers an additional benefit compared with chemoradiation without cetuximab in patients with locally advanced rectal cancer. Methods and Materials: We analyzed EGFR, KRAS, BRAF, and PIK3CA mutation status with direct sequencing and epidermal growth factor receptor (EGFR) and Phosphatase and tensin homolog (PTEN) expression status with immunohistochemistry in tumor samples of 82 patients with locally advanced rectal cancer who were enrolled in the IRIX trial (preoperative chemoradiation with irinotecan and capecitabine; n=44) or the ERBIRIX trial (preoperative chemoradiation with irinotecan and capecitabine plus cetuximab; n=38). Both trials were similarly designed except for the administration of cetuximab; radiation therapy was administered at a dose of 50.4 Gy/28 fractions and irinotecan and capecitabine were given at doses of 40 mg/m{sup 2} weekly and 1650 mg/m{sup 2}/day, respectively, for 5 days per week. In the ERBIRIX trial, cetuximab was additionally given with a loading dose of 400 mg/m{sup 2} on 1 week before radiation, and 250 mg/m{sup 2} weekly thereafter. Results: Baseline characteristics before chemoradiation were similar between the 2 trial cohorts. A KRAS mutation in codon 12, 13, and 61 was noted in 15 (34%) patients in the IRIX cohort and 5 (13%) in the ERBIRIX cohort (P=.028). Among 62 KRAS wild-type cancer patients, major pathologic response rate, disease-free survival and pathologic stage did not differ significantly between the 2 cohorts. No mutations were detected in BRAF exon 11 and 15, PIK3CA exon 9 and 20, or EGFR exon 18-24 in any of the 82 patients, and PTEN and EGFR expression were not predictive of clinical outcome. Conclusions: In patients with KRAS wild-type locally advanced rectal cancer, the addition of cetuximab to the chemoradiation with

  20. KRAS Mutation Status and Clinical Outcome of Preoperative Chemoradiation With Cetuximab in Locally Advanced Rectal Cancer: A Pooled Analysis of 2 Phase II Trials

    International Nuclear Information System (INIS)

    Kim, Sun Young; Shim, Eun Kyung; Yeo, Hyun Yang; Baek, Ji Yeon; Hong, Yong Sang; Kim, Dae Yong; Kim, Tae Won; Kim, Jee Hyun; Im, Seock-Ah; Jung, Kyung Hae; Chang, Hee Jin

    2013-01-01

    Purpose: Cetuximab-containing chemotherapy is known to be effective for KRAS wild-type metastatic colorectal cancer; however, it is not clear whether cetuximab-based preoperative chemoradiation confers an additional benefit compared with chemoradiation without cetuximab in patients with locally advanced rectal cancer. Methods and Materials: We analyzed EGFR, KRAS, BRAF, and PIK3CA mutation status with direct sequencing and epidermal growth factor receptor (EGFR) and Phosphatase and tensin homolog (PTEN) expression status with immunohistochemistry in tumor samples of 82 patients with locally advanced rectal cancer who were enrolled in the IRIX trial (preoperative chemoradiation with irinotecan and capecitabine; n=44) or the ERBIRIX trial (preoperative chemoradiation with irinotecan and capecitabine plus cetuximab; n=38). Both trials were similarly designed except for the administration of cetuximab; radiation therapy was administered at a dose of 50.4 Gy/28 fractions and irinotecan and capecitabine were given at doses of 40 mg/m 2 weekly and 1650 mg/m 2 /day, respectively, for 5 days per week. In the ERBIRIX trial, cetuximab was additionally given with a loading dose of 400 mg/m 2 on 1 week before radiation, and 250 mg/m 2 weekly thereafter. Results: Baseline characteristics before chemoradiation were similar between the 2 trial cohorts. A KRAS mutation in codon 12, 13, and 61 was noted in 15 (34%) patients in the IRIX cohort and 5 (13%) in the ERBIRIX cohort (P=.028). Among 62 KRAS wild-type cancer patients, major pathologic response rate, disease-free survival and pathologic stage did not differ significantly between the 2 cohorts. No mutations were detected in BRAF exon 11 and 15, PIK3CA exon 9 and 20, or EGFR exon 18-24 in any of the 82 patients, and PTEN and EGFR expression were not predictive of clinical outcome. Conclusions: In patients with KRAS wild-type locally advanced rectal cancer, the addition of cetuximab to the chemoradiation with irinotecan plus

  1. Radiotherapy for advanced breast cancer. Immediate results

    Energy Technology Data Exchange (ETDEWEB)

    Lederman, M V; Silveira Filho, L; Martorelli Filho, B [Sao Paulo Univ. (Brazil). Faculdade de Medicina

    1976-01-01

    Seventy-four patients with advanced breast cancer were submited to local radiotherapy of the affected regions. The response of 155 metastatic lesions are recorded. Early results are good, with objective and functional clinical improvement.

  2. Long-term results of PRRT in advanced bronchopulmonary carcinoid

    Energy Technology Data Exchange (ETDEWEB)

    Mariniello, Annapaola; Bodei, Lisa; Baio, Silvia Melania; Gilardi, Laura; Colandrea, Marzia; Papi, Stefano; Grana, Chiara Maria [European Institute of Oncology, Division of Nuclear Medicine, Milan (Italy); Tinelli, Carmine [IRCCS Foundation Policlinico San Matteo, Epidemiology and Biometric Unit, Pavia (Italy); Valmadre, Giuseppe [Presidio Ospedaliero E. Morelli AOVV, Sondalo (Italy); Fazio, Nicola [European Institute of Oncology, Unit of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, Milan (Italy); Galetta, Domenico [European Institute of Oncology, Thoracic Surgery Division, Milan (Italy); Paganelli, Giovanni [Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Nuclear Medicine and Radiometabolic Units, Meldola (Italy)

    2016-03-15

    Peptide receptor radionuclide therapy (PRRT) for the treatment of neuroendocrine tumours (NET) has been explored for almost two decades, but there are still few trials that have exclusively investigated well-differentiated and moderately differentiated NET arising from the respiratory tree. Thus, the aim of this study was to explore the outcome in patients affected by bronchopulmonary carcinoid (BPC) following PRRT. We retrospectively analysed 114 patients with advanced stage BPC consecutively treated with PRRT at the European Institute of Oncology, Milan, from 1997 to 2012 and followed until October 2014. The objective responses, overall survival (OS) and progression-free survival (PFS) were rated, and three different PRRT protocols ({sup 90}Y-DOTATOC vs. {sup 177}Lu-DOTATATE vs. {sup 90}Y-DOTATOC + {sup 177}Lu-DOTATATE) were compared with regard to their efficacy and tolerability. The median OS (evaluated in 94 of the 114 patients) was 58.8 months. The median PFS was 28.0 months. The {sup 177}Lu-DOTATATE protocol resulted in the highest 5-year OS (61.4 %). Morphological responses (partial responses + minor responses) were obtained in 26.5 % of the cohort and were associated with longer OS and PFS. The {sup 90}Y-DOTATOC + {sup 177}Lu-DOTATATE protocol provided the highest response rate (38.1 %). Adverse events were mild in the majority of patients. However, haematological toxicity negatively affected survival. No severe (grade 3/4) serum creatinine increase was observed. Patients treated with {sup 90}Y-DOTATOC alone more frequently showed a mild/moderate decrease in renal function. In patients treated with chemotherapy before PRRT had a shorter OS and PFS, and a higher risk of developing nephrotoxicity. In a large cohort of patients with advanced BPC treated in a ''real-world'' scenario and followed up for a median of 45.1 months (range 2 - 191 months), PRRT proved to be promising in prolonging survival and delaying disease progression. Despite

  3. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial.

    Science.gov (United States)

    Cheng, Ann-Lii; Kang, Yoon-Koo; Lin, Deng-Yn; Park, Joong-Won; Kudo, Masatoshi; Qin, Shukui; Chung, Hyun-Cheol; Song, Xiangqun; Xu, Jianming; Poggi, Guido; Omata, Masao; Pitman Lowenthal, Susan; Lanzalone, Silvana; Yang, Liqiang; Lechuga, Maria Jose; Raymond, Eric

    2013-11-10

    Open-label, phase III trial evaluating whether sunitinib was superior or equivalent to sorafenib in hepatocellular cancer. Patients were stratified and randomly assigned to receive sunitinib 37.5 mg once per day or sorafenib 400 mg twice per day. Primary end point was overall survival (OS). Early trial termination occurred for futility and safety reasons. A total of 1,074 patients were randomly assigned to the study (sunitinib arm, n = 530; sorafenib arm, n = 544). For sunitinib and sorafenib, respectively, median OS was 7.9 versus 10.2 months (hazard ratio [HR], 1.30; one-sided P = .9990; two-sided P = .0014); median progression-free survival (PFS; 3.6 v 3.0 months; HR, 1.13; one-sided P = .8785; two-sided P = .2286) and time to progression (TTP; 4.1 v 3.8 months; HR, 1.13; one-sided P = .8312; two-sided P = .3082) were comparable. Median OS was similar among Asian (7.7 v 8.8 months; HR, 1.21; one-sided P = .9829) and hepatitis B-infected patients (7.6 v 8.0 months; HR, 1.10; one-sided P = .8286), but was shorter with sunitinib in hepatitis C-infected patients (9.2 v 17.6 months; HR, 1.52; one-sided P = .9835). Sunitinib was associated with more frequent and severe adverse events (AEs) than sorafenib. Common grade 3/4 AEs were thrombocytopenia (29.7%) and neutropenia (25.7%) for sunitinib; hand-foot syndrome (21.2%) for sorafenib. Discontinuations owing to AEs were similar (sunitinib, 13.3%; sorafenib, 12.7%). OS with sunitinib was not superior or equivalent but was significantly inferior to sorafenib. OS was comparable in Asian and hepatitis B-infected patients. OS was superior in hepatitis C-infected patients who received sorafenib. Sunitinib-treated patients reported more frequent and severe toxicity.

  4. Weight changes and their predictors amongst 11 140 patients with type 2 diabetes in the ADVANCE trial

    NARCIS (Netherlands)

    van Dieren, S.; Czernichow, S.; Chalmers, J.; Kengne, A. P.; de Galan, B. E.; Poulter, N.; Woodward, M.; Beulens, J. W. J.; Grobbee, D. E.; van der Schouw, Y. T.; Zoungas, S.

    2012-01-01

    To determine the baseline characteristics and glucose-lowering therapies associated with weight change among patients with type 2 diabetes. Eleven thousand one hundred and forty participants in the ADVANCE trial were randomly assigned to an intensive [aiming for a haemoglobin A1c (HbA1c) ≤6.5%] or a

  5. Preoperative chemoradiotherapy with 5-fluorouracil and oxaliplatin for locally advanced rectal cancer: long-term results of a phase II trial.

    Science.gov (United States)

    Liu, Luying; Cao, Caineng; Zhu, Yuan; Li, Dechuan; Feng, Haiyang; Luo, Jialin; Tang, Zhongzhu; Liu, Peng; Lu, Ke; Ju, Haixing; Zhang, Na

    2015-03-01

    The aim of this study was to report long-term results of patients with locally advanced rectal cancer treated by neoadjuvant chemoradiotherapy with fluorouracil, leucovorin, and oxaliplatin. From February 2002 to November 2006, a total of 58 patients with locally advanced rectal cancer were recruited. Secondary endpoints included the cumulative incidence of local and distant recurrences, disease-free survival, and overall survival. The median follow-up time was 138 months (109-151 months). The cumulative incidence of local recurrence at 10 years was 12.1%. The cumulative incidence of distant recurrence at 10 years was 53.4%. The overall survival in the intention-to-treat population was 39.5% at 10 years. Disease-free survival in the intention-to-treat population was 41.8% at 10 years. Univariate analysis revealed that pathologic complete response was associated with local recurrence, distant recurrence, disease-free survival, and overall survival (p rectal cancer after preoperative chemoradiotherapy and total mesorectal excision. Pathologic complete response is an independent prognostic factor for locally advanced rectal cancer after preoperative chemoradiotherapy.

  6. Radiotherapy for advanced breast cancer. Immediate results

    International Nuclear Information System (INIS)

    Lederman, M.V.; Silveira Filho, L.; Martorelli Filho, B.

    1976-01-01

    Seventy-four patients with advanced breast cancer were submited to local radiotherapy of the affected regions. The response of 155 metastatic lesions are recorded. Early results are good, with objective and functional clinical improvement [pt

  7. Effect of an End-of-Life Planning Intervention on the completion of advance directives in homeless persons: a randomized trial.

    Science.gov (United States)

    Song, John; Ratner, Edward R; Wall, Melanie M; Bartels, Dianne M; Ulvestad, Nancy; Petroskas, Dawn; West, Melissa; Weber-Main, Anne Marie; Grengs, Leah; Gelberg, Lillian

    2010-07-20

    Few interventions have focused on improving end-of-life care for underserved populations, such as homeless persons. To determine whether homeless persons will complete a counseling session on advance care planning and fill out a legal advance directive designed to assess care preferences and preserve the dignity of marginalized persons. Prospective, single-blind, randomized trial comparing self-guided completion of an advance directive with professionally assisted advance care planning. (ClinicalTrials.gov registration number: NCT00546884) 8 sites serving homeless persons in Minneapolis, Minnesota. 262 homeless persons recruited between November 2007 and August 2008. Minimal, self-guided intervention consisting of advance directive forms and written educational information versus a one-on-one advance planning intervention consisting of counseling and completing an advance directive with a social worker. Rate of advance directive completion, assessed by inspection of completed documents. The overall completion rate for advance directives was 26.7% (95% CI, 21.5% to 32.5%), with a higher rate in the counselor-guided group (37.9%) than in the self-guided group (12.8%) (CI of adjusted difference, 15.3 to 34.3 percentage points). This difference persisted across all sites and most subgroups. The advance directive's 4 clinical scenarios found a preference for surrogate decision making in 29% to 34% of written responses. Sampling was limited to a more stable subset of the homeless population in Minneapolis and may have been subject to selection bias. Modest compensation to complete the preintervention survey could have influenced participants to complete advance directives. Both a simple and complex intervention successfully engaged a diverse sample of homeless persons in advance care planning. One-on-one assistance significantly increased the completion rate. Homeless persons can respond to an intervention to plan for end-of-life care and can express specific preferences

  8. The effect of vitamin D on primary dysmenorrhea with vitamin D deficiency: a randomized double-blind controlled clinical trial.

    Science.gov (United States)

    Moini, Ashraf; Ebrahimi, Tabandeh; Shirzad, Nooshin; Hosseini, Reihaneh; Radfar, Mania; Bandarian, Fatemeh; Jafari-Adli, Shahrzad; Qorbani, Mostafa; Hemmatabadi, Mahboobeh

    2016-06-01

    Dysmenorrhea is common among women of reproductive age. This study aim was to investigate the effect of vitamin D (vit D) supplementation in treatment of primary dysmenorrhea with vit D deficiency. A randomized double-blind placebo-controlled clinical trial was conducted on 60 women with primary dysmenorrhea and vit D deficiency referred to our clinic at Arash Women's Hospital from September 2013 to December 2014. Eligible women were randomly assigned into treatment and control groups (30 in each group). Individuals in the treatment group received 50 000 IU oral vit D and the control group received placebo weekly for eight weeks. After two months of treatment, there was a significant difference in serum vit D concentration between the two groups (p dysmenorrhea and vit D deficiency could improve pain intensity.

  9. Validation of a real-time PCR based method for detection of Clostridium botulinum types C, D and their mosaic variants C-D and D-C in a multicenter collaborative trial

    DEFF Research Database (Denmark)

    Woudstra, C.; Skarin, H.; Anniballi, F.

    2013-01-01

    Two real-time PCR arrays based on the GeneDisc® cycler platform (Pall-GeneDisc Technologies) were evaluated in a multicenter collaborative trial for their capacity to specifically detect and discriminate Clostridium botulinum types C, D and their mosaic variants C-D and D-C that are associated wi...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... they advance medical knowledge and help improve patient care. Sponsorship and Funding The National Heart, Lung, and ...

  11. Age of menopause and fracture risk in postmenopausal women randomized to calcium + vitamin D, hormone therapy, or the combination: results from the Women's Health Initiative Clinical Trials.

    Science.gov (United States)

    Sullivan, Shannon D; Lehman, Amy; Nathan, Nisha K; Thomson, Cynthia A; Howard, Barbara V

    2017-04-01

    We previously reported that in the absence of hormone therapy (HT) or calcium/vitamin D (Ca/D) supplementation, earlier menopause age was associated with decreased bone mineral density and increased fracture risk in healthy postmenopausal women. Treatment with HT and Ca/D is protective against fractures after menopause. In this analysis, we asked if the age of menopause onset alters fracture risk in healthy postmenopausal women receiving HT, Ca/D, or a combination. Hazard ratios (HRs) for any fracture among 21,711 healthy postmenopausal women enrolled in the Women's Health Initiative Clinical Trial, who were treated with HT, Ca/D, or HT + Ca/D, and who reported age of nonsurgical menopause of menopause menopause 40 to 49 or ≥50 years, regardless of treatment intervention (HR [95% CI]: menopause menopause menopause age (menopause ages. The effect of menopause age on fracture risk was not altered by any of the treatment interventions (HT, Ca/D, HT + Ca/D), suggesting that early age of menopause is an independent contributor to postmenopausal fracture risk.

  12. Effects of a Group-Mediated Exercise and Dietary Intervention in the Treatment of Prostate Cancer Patients Undergoing Androgen Deprivation Therapy: Results From the IDEA-P Trial.

    Science.gov (United States)

    Focht, Brian C; Lucas, Alexander R; Grainger, Elizabeth; Simpson, Christina; Fairman, Ciaran M; Thomas-Ahner, Jennifer M; Buell, Jackie; Monk, J Paul; Mortazavi, Amir; Clinton, Steven K

    2018-04-19

    Although androgen-deprivation therapy (ADT) is the foundation of treatment for prostate cancer, the physiological impacts of ADT result in functional decline and enhanced risk of chronic disease and metabolic syndrome. The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) is a single-blind, randomized, pilot trial comparing the effects of a group-mediated, cognitive-behavioral (GMCB) exercise and dietary intervention (EX+D) with those of a standard-of-care (SC) control during the treatment of prostate cancer patients undergoing ADT. A total of 32 prostate cancer patients (M age = 66.28, SD = 7.79) undergoing ADT were randomly assigned to the 12-week EX+D intervention (n = 16) or control (n = 16). The primary outcome in IDEA-P was change in mobility performance with secondary outcomes including body composition and muscular strength. Blinded assessment of outcomes were obtained at baseline and at 2- and 3-month follow-ups. Favorable adherence and retention rates were observed, and no serious intervention-related adverse events were documented. Intent-to-treat ANCOVA controlling for baseline value and ADT duration demonstrated that EX+D resulted in significantly greater improvements in mobility performance (p < .02), muscular strength (p < .01), body fat percentage (p < .05), and fat mass (p < .03) at 3-month follow-up, relative to control. Findings from the IDEA-P trial suggest that a GMCB-based EX+D intervention resulted in significant, clinically meaningful improvements in mobility performance, muscular strength, and body composition, relative to controls. Collectively, these results suggest that the EX+D was a safe and well-tolerated intervention for prostate cancer patients on ADT. The utility of implementing this approach in the treatment of prostate cancer patients on ADT should be evaluated in future large-scale efficacy trials. NCT02050906.

  13. Beam Optics Analysis - An Advanced 3D Trajectory Code

    International Nuclear Information System (INIS)

    Ives, R. Lawrence; Bui, Thuc; Vogler, William; Neilson, Jeff; Read, Mike; Shephard, Mark; Bauer, Andrew; Datta, Dibyendu; Beal, Mark

    2006-01-01

    Calabazas Creek Research, Inc. has completed initial development of an advanced, 3D program for modeling electron trajectories in electromagnetic fields. The code is being used to design complex guns and collectors. Beam Optics Analysis (BOA) is a fully relativistic, charged particle code using adaptive, finite element meshing. Geometrical input is imported from CAD programs generating ACIS-formatted files. Parametric data is inputted using an intuitive, graphical user interface (GUI), which also provides control of convergence, accuracy, and post processing. The program includes a magnetic field solver, and magnetic information can be imported from Maxwell 2D/3D and other programs. The program supports thermionic emission and injected beams. Secondary electron emission is also supported, including multiple generations. Work on field emission is in progress as well as implementation of computer optimization of both the geometry and operating parameters. The principle features of the program and its capabilities are presented

  14. Chemotherapy in locally advanced nasopharyngeal carcinoma: An individual patient data meta-analysis of eight randomized trials and 1753 patients

    International Nuclear Information System (INIS)

    Baujat, Bertrand; Audry, Helene; Bourhis, Jean; Chan, Anthony T.C.; Onat, Haluk; Chua, Daniel T.T.; Kwong, Dora L.W.; Al-Sarraf, Muhyi; Chi, K.-H.; Hareyama, Masato; Leung, Sing F.; Thephamongkhol, Kullathorn; Pignon, Jean-Pierre

    2006-01-01

    Objectives: To study the effect of adding chemotherapy to radiotherapy (RT) on overall survival and event-free survival for patients with nasopharyngeal carcinoma. Methods and Materials: This meta-analysis used updated individual patient data from randomized trials comparing chemotherapy plus RT with RT alone in locally advanced nasopharyngeal carcinoma. The log-rank test, stratified by trial, was used for comparisons, and the hazard ratios of death and failure were calculated. Results: Eight trials with 1753 patients were included. One trial with a 2 x 2 design was counted twice in the analysis. The analysis included 11 comparisons using the data from 1975 patients. The median follow-up was 6 years. The pooled hazard ratio of death was 0.82 (95% confidence interval, 0.71-0.94; p = 0.006), corresponding to an absolute survival benefit of 6% at 5 years from the addition of chemotherapy (from 56% to 62%). The pooled hazard ratio of tumor failure or death was 0.76 (95% confidence interval, 0.67-0.86; p < 0.0001), corresponding to an absolute event-free survival benefit of 10% at 5 years from the addition of chemotherapy (from 42% to 52%). A significant interaction was observed between the timing of chemotherapy and overall survival (p = 0.005), explaining the heterogeneity observed in the treatment effect (p = 0.03), with the highest benefit resulting from concomitant chemotherapy. Conclusion: Chemotherapy led to a small, but significant, benefit for overall survival and event-free survival. This benefit was essentially observed when chemotherapy was administered concomitantly with RT

  15. Vismodegib in patients with advanced basal cell carcinoma (STEVIE): a pre-planned interim analysis of an international, open-label trial.

    Science.gov (United States)

    Basset-Seguin, Nicole; Hauschild, Axel; Grob, Jean-Jacques; Kunstfeld, Rainer; Dréno, Brigitte; Mortier, Laurent; Ascierto, Paolo A; Licitra, Lisa; Dutriaux, Caroline; Thomas, Luc; Jouary, Thomas; Meyer, Nicolas; Guillot, Bernard; Dummer, Reinhard; Fife, Kate; Ernst, D Scott; Williams, Sarah; Fittipaldo, Alberto; Xynos, Ioannis; Hansson, Johan

    2015-06-01

    The Hedgehog pathway inhibitor vismodegib has shown clinical benefit in patients with advanced basal cell carcinoma and is approved for treatment of patients with advanced basal cell carcinoma for whom surgery is inappropriate. STEVIE was designed to assess the safety of vismodegib in a situation similar to routine practice, with a long follow-up. In this multicentre, open-label trial, adult patients with histologically confirmed locally advanced basal cell carcinoma or metastatic basal cell carcinoma were recruited from regional referral centres or specialist clinics. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, and adequate organ function. Patients with locally advanced basal cell carcinoma had to have been deemed ineligible for surgery. All patients received 150 mg oral vismodegib capsules once a day on a continuous basis in 28-day cycles. The primary objective was safety (incidence of adverse events until disease progression or unacceptable toxic effects), with assessments on day 1 of each treatment cycle (28 days) by principal investigator and coinvestigators at the site. Efficacy variables were assessed as secondary endpoints. The safety evaluable population included all patients who received at least one dose of study drug. Patients with histologically confirmed basal cell carcinoma who received at least one dose of study drug were included in the efficacy analysis. An interim analysis was pre-planned after 500 patients achieved 1 year of follow-up. This trial is registered with ClinicalTrials.gov, number NCT01367665. The study is still ongoing. Between June 30, 2011, and Nov 6, 2014, we enrolled 1227 patients. At clinical cutoff (Nov 6, 2013), 499 patients (468 with locally advanced basal cell carcinoma and 31 with metastatic basal cell carcinoma) had received study drug and had the potential to be followed up for 12 months or longer. Treatment was discontinued in 400 (80

  16. Effect of maternal vitamin D3 supplementation on maternal health, birth outcomes, and infant growth among HIV-infected Tanzanian pregnant women: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Sudfeld, Christopher R; Manji, Karim P; Duggan, Christopher P; Aboud, Said; Muhihi, Alfa; Sando, David M; Al-Beity, Fadhlun M Alwy; Wang, Molin; Fawzi, Wafaie W

    2017-09-04

    Vitamin D has significant immunomodulatory effects on both adaptive and innate immune responses. Observational studies indicate that adults infected with HIV with low vitamin D status may be at increased risk of mortality, pulmonary tuberculosis, and HIV disease progression. Growing observational evidence also suggests that low vitamin D status in pregnancy may increase the risk of adverse birth and infant health outcomes. As a result, antiretroviral therapy (ART) adjunct vitamin D 3 supplementation may improve the health of HIV-infected pregnant women and their children. The Trial of Vitamins-5 (ToV5) is an individually randomized, double-blind, placebo-controlled trial of maternal vitamin D 3 (cholecalciferol) supplementation conducted among 2300 HIV-infected pregnant women receiving triple-drug ART under Option B+ in Dar es Salaam, Tanzania. HIV-infected pregnant women of 12-27 weeks gestation are randomized to either: 1) 3000 IU vitamin D 3 taken daily from randomization in pregnancy until trial discharge at 12 months postpartum; or 2) a matching placebo regimen. Maternal participants are followed-up at monthly clinic visits during pregnancy, at delivery, and then with their children at monthly postpartum clinic visits. The primary efficacy outcomes of the trial are: 1) maternal HIV disease progression or death; 2) risk of small-for-gestational age (SGA) births; and 3) risk of infant stunting at 1 year of age. The primary safety outcome of the trial is incident maternal hypercalcemia. Secondary outcomes include a range of clinical and biological maternal and child health outcomes. The ToV5 will provide causal evidence on the effect of vitamin D 3 supplementation on HIV progression and death, SGA births, and infant stunting at 1 year of age. The results of the trial are likely generalizable to HIV-infected pregnant women and their children in similar resource-limited settings utilizing the Option B+ approach. ClinicalTrials.gov identifier: NCT02305927

  17. Risk of adverse events with bevacizumab addition to therapy in advanced non-small-cell lung cancer: a meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Lai XX

    2016-04-01

    Full Text Available Xi-Xi Lai, Ren-Ai Xu, Yu-Ping Li, Han Yang Department of Respiratory Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People’s Republic of China Background: Bevacizumab, a monoclonal antibody against vascular endothelial growth factor ligand, has shown survival benefits in the treatment of many types of malignant tumors, including non-small-cell lung cancer (NSCLC. We conducted this systematic review and meta-analysis to investigate the risk of the most clinically relevant adverse events related to bevacizumab in advanced NSCLC.Methods: Databases from PubMed, Web of Science, and Cochrane Library up to August 2015, were searched to identify relevant studies. We included prospective randomized controlled Phase II/III clinical trials that compared therapy with or without bevacizumab for advanced NSCLC. Summary relative risk (RR and 95% confidence intervals were calculated using random effects or fixed effects according to the heterogeneity among included trials.Results: A total of 3,745 patients from nine clinical trials were included in the meta-analysis. Summary RRs showed a statistically significant bevacizumab-associated increased risk in three of the adverse outcomes studied: proteinuria (RR =7.55, hypertension (RR =5.34, and hemorrhagic events (RR =2.61. No statistically significant differences were found for gastrointestinal perforation (P=0.60, arterial and venous thromboembolic events (P=0.35 and P=0.92, respectively, or fatal events (P=0.29.Conclusion: The addition of bevacizumab to therapy in advanced NSCLC did significantly increase the risk of proteinuria, hypertension, and hemorrhagic events but not arterial/venous thromboembolic events, gastrointestinal perforation, or fatal adverse events. Keywords: toxicities, angiogenesis inhibitors, non-small-cell lung carcinoma, meta-analysis, safety

  18. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial.

    Science.gov (United States)

    Maruani, Annabel; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe

    2014-09-19

    To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results. Cohort embedded pragmatic randomized controlled trial. Trials registered on ClinicalTrials.gov. 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails structured as a survey and sent by one of us to responsible parties of the trials, indirectly reminding them of the legal requirement and potential penalties for non-compliance). The primary outcome was the proportion of results posted on ClinicalTrials.gov at three months. The secondary outcome was the proportion posted at six months. In a second step, two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov. A post hoc sensitivity analysis excluding trials wrongly included was performed. Among 379 trials included, 190 were randomized to receive the email intervention. The rate of posting of results did not differ at three months between trials with or without the intervention: 36/190 (19%) v 24/189 (13%), respectively (relative risk 1.5, 95% confidence interval 0.9 to 2.4, P=0.096) but did at six months: 46/190 (24%) v 27/189 (14%), 1.7, 1.1 to 2.6, P=0.014. In the sensitivity analysis, which excluded 48/379 trials (13%), 26/190 (14%) and 22/189 (12%), respectively, results were significant at three months (relative risk 5.1, 1.1 to 22.9, P=0.02) and at six months (4.1, 1.3 to 10.6, P=0.001). Sending email reminders about the FDA's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT01658254. © Maruani et al 2014.

  19. 3D laparoscopic surgery: a prospective clinical trial.

    Science.gov (United States)

    Agrusa, Antonino; Di Buono, Giuseppe; Buscemi, Salvatore; Cucinella, Gaspare; Romano, Giorgio; Gulotta, Gaspare

    2018-04-03

    Since it's introduction, laparoscopic surgery represented a real revolution in clinical practice. The use of a new generation three-dimensional (3D) HD laparoscopic system can be considered a favorable "hybrid" made by combining two different elements: feasibility and diffusion of laparoscopy and improved quality of vision. In this study we report our clinical experience with use of three-dimensional (3D) HD vision system for laparoscopic surgery. Between 2013 and 2017 a prospective cohort study was conducted at the University Hospital of Palermo. We considered 163 patients underwent to laparoscopic three-dimensional (3D) HD surgery for various indications. This 3D-group was compared to a retrospective-prospective control group of patients who underwent the same surgical procedures. Considerating specific surgical procedures there is no significant difference in term of age and gender. The analysis of all the groups of diseases shows that the laparoscopic procedures performed with 3D technology have a shorter mean operative time than comparable 2D procedures when we consider surgery that require complex tasks. The use of 3D laparoscopic technology is an extraordinary innovation in clinical practice, but the instrumentation is still not widespread. Precisely for this reason the studies in literature are few and mainly limited to the evaluation of the surgical skills to the simulator. This study aims to evaluate the actual benefits of the 3D laparoscopic system integrating it in clinical practice. The three-dimensional view allows advanced performance in particular conditions, such as small and deep spaces and promotes performing complex surgical laparoscopic procedures.

  20. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... and advance medical care. They also can help health care decisionmakers direct resources to the strategies and treatments ...

  1. Sexual Function After Three-Dimensional Conformal Radiotherapy for Prostate Cancer: Results From a Dose-Escalation Trial

    International Nuclear Information System (INIS)

    Wielen, Gerard J. van der; Putten, Wim van; Incrocci, Luca

    2007-01-01

    Purpose: The purpose of this study is to provide information about sexual function (SF) after three-dimensional conformal radiotherapy (3D-CRT) for prostate cancer while taking important factors into account that influence SF. Methods and Materials: Between June 1997 and February 2003, a total of 268 patients from a randomized dose-escalation trial comparing 68 Gy and 78 Gy agreed to participate in an additional part of the trial that evaluated SF. Results: At baseline 28% of patients had erectile dysfunction (ED). After 1 year, 27% of the pretreatment potent patients had developed ED. After 2 years this percentage had increased to 36%. After 3 years it almost stabilized at 38%. Satisfaction with sexual life was significantly correlated with ED. After 2 years one third of the pre-treatment potent patients still had considerable to very much sexual desire and found sex (very) important. No significant differences were found between the two dose-arms. Potency aids were used on a regular base by 14% of the patients. Conclusion: By taking adjuvant hormonal therapy (HT), HT during follow-up and potency aids into account, we found a lower percentage of ED after 3D-CRT than reported in previous prospective studies. A large group of patients still had sexual desire, considered sex important and 14% used potency aids after 3D-CRT

  2. Preliminary results for avelumab plus axitinib as first-line therapy in patients with advanced clear-cell renal-cell carcinoma (JAVELIN Renal 100): an open-label, dose-finding and dose-expansion, phase 1b trial.

    Science.gov (United States)

    Choueiri, Toni K; Larkin, James; Oya, Mototsugu; Thistlethwaite, Fiona; Martignoni, Marcella; Nathan, Paul; Powles, Thomas; McDermott, David; Robbins, Paul B; Chism, David D; Cho, Daniel; Atkins, Michael B; Gordon, Michael S; Gupta, Sumati; Uemura, Hirotsugu; Tomita, Yoshihiko; Compagnoni, Anna; Fowst, Camilla; di Pietro, Alessandra; Rini, Brian I

    2018-04-01

    The combination of an immune checkpoint inhibitor and a VEGF pathway inhibitor to treat patients with advanced renal-cell carcinoma might increase the clinical benefit of these drugs compared with their use alone. Here, we report preliminary results for the combination of avelumab, an IgG1 monoclonal antibody against the programmed cell death protein ligand PD-L1, and axitinib, a VEGF receptor inhibitor approved for second-line treatment of advanced renal-cell carcinoma, in treatment-naive patients with advanced renal-cell carcinoma. The JAVELIN Renal 100 study is an ongoing open-label, multicentre, dose-finding, and dose-expansion, phase 1b study, done in 14 centres in the USA, UK, and Japan. Eligible patients were aged 18 years or older (≥20 years in Japan) and had histologically or cytologically confirmed advanced renal-cell carcinoma with clear-cell component, life expectancy of at least 3 months, an Eastern Cooperative Oncology Group performance status of 1 or less, received no previous systemic treatment for advanced renal cell carcinoma, and had a resected primary tumour. Patients enrolled into the dose-finding phase received 5 mg axitinib orally twice daily for 7 days, followed by combination therapy with 10 mg/kg avelumab intravenously every 2 weeks and 5 mg axitinib orally twice daily. Based on the pharmacokinetic data from the dose-finding phase, ten additional patients were enrolled into the dose-expansion phase and assigned to this regimen. The other patients in the dose-expansion phase started taking combination therapy directly. The primary endpoint was dose-limiting toxicities in the first 4 weeks (two cycles) of treatment with avelumab plus axitinib. Safety and antitumour activity analyses were done in all patients who received at least one dose of avelumab or axitinib. This trial is registered with ClinicalTrials.gov, number NCT02493751. Between Oct 30, 2015, and Sept 30, 2016, we enrolled six patients into the dose-finding phase and 49 into the

  3. Effects of vitamin D2-fortified bread v. supplementation with vitamin D2 or D3 on serum 25-hydroxyvitamin D metabolites: an 8-week randomised-controlled trial in young adult Finnish women

    DEFF Research Database (Denmark)

    Itkonen, Suvi T.; Skaffari, Essi; Saaristo, Pilvi

    2016-01-01

    -irradiated yeast present in bread in an 8-week randomised-controlled trial in healthy 20–37-year-old women (n 33) in Helsinki (60°N) during winter (February–April) 2014. Four study groups were given different study products (placebo pill and regular bread=0 µg D2 or D3/d; D2 supplement and regular bread=25 µg D2/d......; D3 supplement and regular bread=25 µg D3/d; and placebo pill and D2-biofortified bread=25 µg D2/d). Serum 25-hydroxyvitamin D2 (S-25(OH)D2) and serum 25-hydroxyvitamin D3 (S-25(OH)D3) concentrations were measured at baseline, midpoint and end point. The mean baseline total serum 25-hydroxyvitamin D...

  4. Use of vitamin D supplements during infancy in an international feeding trial

    DEFF Research Database (Denmark)

    Lehtonen, Eveliina; Ormisson, Anne; Nucci, Anita

    2014-01-01

    OBJECTIVE: To examine the use of vitamin D supplements during infancy among the participants in an international infant feeding trial. DESIGN: Longitudinal study. SETTING: Information about vitamin D supplementation was collected through a validated FFQ at the age of 2 weeks and monthly between...... supplements was common during the first 6 months of life in Northern and Central Europe (>80% of the infants), with somewhat lower rates observed in Southern Europe (> 60%). In Canada, vitamin D supplementation was more common among exclusively breast-fed than other infants (e.g., 71% v. 44% at 6 months...... of age). Less than 2% of infants in the U.S.A. and Australia received any vitamin D supplementation. Higher gestational age, older maternal age and longer maternal education were study-wide associated with greater use of vitamin D supplements. CONCLUSIONS: Most of the infants received vitamin D...

  5. Phase I trial of neoadjuvant concurrent chemoradiotherapy with S-1 and weekly irinotecan in locally advanced rectal cancer

    International Nuclear Information System (INIS)

    Choi, Hye Jin; Kim, Nam-Kyu; Keum, Ki Chang; Cheon, Seong Ha; Shin, Sang Jun; Baik, Seung Hyuk; Choen, Jae Hee; Rha, Sun Young; Roh, Jae Kyung; Jeung, Hei-Cheul; Chung, Hyun Cheol; Ahn, Joong Bae

    2008-01-01

    S-1 is a novel, oral fluoropyrimidine and a known radiosensitizer. We conducted a phase I trial to establish a schedule of S-1/irinotecan with standard pelvic radiotherapy as a preoperative treatment of locally advanced rectal cancer. Our findings suggest that this new combination is feasible and well tolerable

  6. A randomized trial comparing radical prostatectomy plus endocrine therapy versus external beam radiotherapy plus endocrine therapy for locally advanced prostate cancer. Results at median follow-up of 102 months

    International Nuclear Information System (INIS)

    Akakura, Koichiro; Suzuki, Hiroyoshi; Ichikawa, Tomohiko

    2006-01-01

    The background of this study was to investigate the optimal treatment of locally advanced prostate cancer, a prospective randomized trial was conducted to compare radical prostatectomy plus endocrine therapy versus external beam radiotherapy plus endocrine therapy. One hundred patients with T2b-3N0M0 prostate cancer were enrolled and 95 were evaluated. Of 95 cases, 46 underwent radical prostatectomy with pelvic lymph node dissection and 49 were treated with external beam radiation by linear accelerator with 40-50 Gy to the whole pelvis and 20-Gy boost to the prostatic area. For all patients, endocrine therapy was initiated 8 weeks before surgery or radiotherapy and continued thereafter. The long-term outcome and morbidity were examined. Median follow-up period was 102 months. At 10 years overall survival rates in the surgery group were better than the radiation group (76.2% versus 71.1% for biochemical progression-free rates; P=0.25, 83.5% versus 66.1% for clinical progression-free rates; P=0.14, 85.7% versus 77.1% for cause-specific survival rates; P=0.06, and 67.9% versus 60.9% for overall survival rates; P=0.30), although none of them reached statistical significance. Erectile dysfunction was recognized in almost all patients as a result of continuous endocrine therapy. Incontinence requiring more than one pad per day was observed more frequently in the surgery group than the radiation group (P<0.01). For the treatment of patients with locally advanced prostate cancer, when combined with endocrine therapy, either radical prostatectomy or external beam radiotherapy demonstrated favorable long-term outcomes. The radiation dose of 60-70 Gy might not be enough for the local treatment of locally advanced prostate cancer. (author)

  7. Advances in ultrasonic testing of austenitic stainless steel welds. Towards a 3D description of the material including attenuation and optimisation by inversion

    Science.gov (United States)

    Moysan, J.; Gueudré, C.; Ploix, M.-A.; Corneloup, G.; Guy, Ph.; Guerjouma, R. El; Chassignole, B.

    In the case of multi-pass welds, the material is very difficult to describe due to its anisotropic and heterogeneous properties. Anisotropy results from the metal solidification and is correlated with the grain orientation. A precise description of the material is one of the key points to obtain reliable results with wave propagation codes. A first advance is the model MINA which predicts the grain orientations in multi-pass 316-L steel welds. For flat position welding, good predictions of the grains orientations were obtained using 2D modelling. In case of welding in position the resulting grain structure may be 3D oriented. We indicate how the MINA model can be improved for 3D description. A second advance is a good quantification of the attenuation. Precise measurements are obtained using plane waves angular spectrum method together with the computation of the transmission coefficients for triclinic material. With these two first advances, the third one is now possible: developing an inverse method to obtain the material description through ultrasonic measurements at different positions.

  8. Nivolumab-Based Treatments for Advanced Melanoma

    Science.gov (United States)

    A summary of results from an international, double-blind, randomized phase III trial testing the combination of nivolumab (Opdivo®) and ipilimumab (Yervoy®) against nivolumab alone and ipilimumab alone in patients with advanced melanoma.

  9. Sculpting 3D worlds with music: advanced texturing techniques

    Science.gov (United States)

    Greuel, Christian; Bolas, Mark T.; Bolas, Niko; McDowall, Ian E.

    1996-04-01

    Sound within the virtual environment is often considered to be secondary to the graphics. In a typical scenario, either audio cues are locally associated with specific 3D objects or a general aural ambiance is supplied in order to alleviate the sterility of an artificial experience. This paper discusses a completely different approach, in which cues are extracted from live or recorded music in order to create geometry and control object behaviors within a computer- generated environment. Advanced texturing techniques used to generate complex stereoscopic images are also discussed. By analyzing music for standard audio characteristics such as rhythm and frequency, information is extracted and repackaged for processing. With the Soundsculpt Toolkit, this data is mapped onto individual objects within the virtual environment, along with one or more predetermined behaviors. Mapping decisions are implemented with a user definable schedule and are based on the aesthetic requirements of directors and designers. This provides for visually active, immersive environments in which virtual objects behave in real-time correlation with the music. The resulting music-driven virtual reality opens up several possibilities for new types of artistic and entertainment experiences, such as fully immersive 3D `music videos' and interactive landscapes for live performance.

  10. Use of 3D printed models in medical education: A randomized control trial comparing 3D prints versus cadaveric materials for learning external cardiac anatomy.

    Science.gov (United States)

    Lim, Kah Heng Alexander; Loo, Zhou Yaw; Goldie, Stephen J; Adams, Justin W; McMenamin, Paul G

    2016-05-06

    Three-dimensional (3D) printing is an emerging technology capable of readily producing accurate anatomical models, however, evidence for the use of 3D prints in medical education remains limited. A study was performed to assess their effectiveness against cadaveric materials for learning external cardiac anatomy. A double blind randomized controlled trial was undertaken on undergraduate medical students without prior formal cardiac anatomy teaching. Following a pre-test examining baseline external cardiac anatomy knowledge, participants were randomly assigned to three groups who underwent self-directed learning sessions using either cadaveric materials, 3D prints, or a combination of cadaveric materials/3D prints (combined materials). Participants were then subjected to a post-test written by a third party. Fifty-two participants completed the trial; 18 using cadaveric materials, 16 using 3D models, and 18 using combined materials. Age and time since completion of high school were equally distributed between groups. Pre-test scores were not significantly different (P = 0.231), however, post-test scores were significantly higher for 3D prints group compared to the cadaveric materials or combined materials groups (mean of 60.83% vs. 44.81% and 44.62%, P = 0.010, adjusted P = 0.012). A significant improvement in test scores was detected for the 3D prints group (P = 0.003) but not for the other two groups. The finding of this pilot study suggests that use of 3D prints do not disadvantage students relative to cadaveric materials; maximally, results suggest that 3D may confer certain benefits to anatomy learning and supports their use and ongoing evaluation as supplements to cadaver-based curriculums. Anat Sci Educ 9: 213-221. © 2015 American Association of Anatomists. © 2015 American Association of Anatomists.

  11. Primary HPV screening for cervical cancer prevention: results from European trials

    DEFF Research Database (Denmark)

    Lynge, Elsebeth; Rebolj, Matejka

    2009-01-01

    testing increased the detection of cervical intraepithelial neoplasia (CIN) grade 2+. Detection of CIN3+ was significantly increased in two trials (relative risks [RRs] 1.70 and 2.26), but not in three other trials (RRs 1.03, 1.09 and 1.31). In three trials, seven extra women had a false-positive test......Six European, randomized, controlled trials that will compare human papillomavirus (HPV) testing with cytological testing for cervical screening are under way. We reviewed the results published so far to compare the benefits and costs for participating women. At baseline screening, use of HPV...

  12. MAVIDOS Maternal Vitamin D Osteoporosis Study: study protocol for a randomized controlled trial. The MAVIDOS Study Group.

    Science.gov (United States)

    Harvey, Nicholas C; Javaid, Kassim; Bishop, Nicholas; Kennedy, Stephen; Papageorghiou, Aris T; Fraser, Robert; Gandhi, Saurabh V; Schoenmakers, Inez; Prentice, Ann; Cooper, Cyrus

    2012-02-07

    MAVIDOS is a randomised, double-blind, placebo-controlled trial (ISRCTN82927713, registered 2008 Apr 11), funded by Arthritis Research UK, MRC, Bupa Foundation and NIHR. Osteoporosis is a major public health problem as a result of associated fragility fractures. Skeletal strength increases from birth to a peak in early adulthood. This peak predicts osteoporosis risk in later life. Vitamin D insufficiency in pregnancy is common (31% in a recent Southampton cohort) and predicts reduced bone mass in the offspring. In this study we aim to test whether offspring of mothers supplemented with vitamin D in pregnancy have higher bone mass at birth than those whose mothers were not supplemented. Women have their vitamin D status assessed after ultrasound scanning in the twelfth week of pregnancy at 3 trial centres (Southampton, Sheffield, Oxford). Women with circulating 25(OH)-vitamin D levels 25-100 nmol/l are randomised in a double-blind design to either oral vitamin D supplement (1000 IU cholecalciferol/day, n = 477) or placebo at 14 weeks (n = 477). Questionnaire data include parity, sunlight exposure, dietary information, and cigarette and alcohol consumption. At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH)-vitamin D, PTH and biochemistry. At delivery venous umbilical cord blood is collected, together with umbilical cord and placental tissue. The babies undergo DXA assessment of bone mass within the first 14 days after birth, with the primary outcome being whole body bone mineral content adjusted for gestational age and age. Children are then followed up with yearly assessment of health, diet, physical activity and anthropometric measures, with repeat assessment of bone mass by DXA at age 4 years. As far as we are aware, this randomised trial is one of the first ever tests of the early life origins hypothesis in human participants and has the potential to inform public health policy regarding vitamin D supplementation in

  13. MAVIDOS Maternal Vitamin D Osteoporosis Study: study protocol for a randomized controlled trial. The MAVIDOS Study Group

    Directory of Open Access Journals (Sweden)

    Harvey Nicholas C

    2012-02-01

    Full Text Available Abstract MAVIDOS is a randomised, double-blind, placebo-controlled trial (ISRCTN82927713, registered 2008 Apr 11, funded by Arthritis Research UK, MRC, Bupa Foundation and NIHR. Background Osteoporosis is a major public health problem as a result of associated fragility fractures. Skeletal strength increases from birth to a peak in early adulthood. This peak predicts osteoporosis risk in later life. Vitamin D insufficiency in pregnancy is common (31% in a recent Southampton cohort and predicts reduced bone mass in the offspring. In this study we aim to test whether offspring of mothers supplemented with vitamin D in pregnancy have higher bone mass at birth than those whose mothers were not supplemented. Methods/Design Women have their vitamin D status assessed after ultrasound scanning in the twelfth week of pregnancy at 3 trial centres (Southampton, Sheffield, Oxford. Women with circulating 25(OH-vitamin D levels 25-100 nmol/l are randomised in a double-blind design to either oral vitamin D supplement (1000 IU cholecalciferol/day, n = 477 or placebo at 14 weeks (n = 477. Questionnaire data include parity, sunlight exposure, dietary information, and cigarette and alcohol consumption. At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH-vitamin D, PTH and biochemistry. At delivery venous umbilical cord blood is collected, together with umbilical cord and placental tissue. The babies undergo DXA assessment of bone mass within the first 14 days after birth, with the primary outcome being whole body bone mineral content adjusted for gestational age and age. Children are then followed up with yearly assessment of health, diet, physical activity and anthropometric measures, with repeat assessment of bone mass by DXA at age 4 years. Discussion As far as we are aware, this randomised trial is one of the first ever tests of the early life origins hypothesis in human participants and has the potential to inform

  14. Phase I study evaluating the treatment of patients with locally advanced pancreatic cancer with carbon ion radiotherapy: the PHOENIX-01 trial

    International Nuclear Information System (INIS)

    Combs, Stephanie E; Debus, Jürgen; Habermehl, Daniel; Kieser, Meinhard; Dreher, Constantin; Werner, Jens; Haselmann, Renate; Jäkel, Oliver; Jäger, Dirk; Büchler, Markus W

    2013-01-01

    Treatment options for patients with locally advanced pancreatic cancer include surgery, chemotherapy as well as radiotherapy. In many cases, surgical resection is not possible, and therefore treatment alternatives have to be performed. Chemoradiation has been established as a convincing treatment alternative for locally advanced pancreatic cancer. Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 1.16 and 2.46 depending on the pancreatic cancer cell line as well as the endpoint analyzed. Japanese Data on the evaluation of carbon ion radiation therapy showed promising results for patients with pancreatic cancer. The present PHOENIX-01 trial evaluates carbon ion radiotherapy using the active rasterscanning technique in patients with advanced pancreatic cancer in combination with weekly gemcitabine and adjuvant gemcitabine. Primary endpoint is toxicity, secondary endpoints are overall survival, progression-free survival and response. The physical and biological properties of the carbon ion beam promise to improve the therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg peak can be directed into the defined target volume, and the sharp dose fall-off thereafter again spares normal tissue behind the target volume. The higher RBE of carbon ions, which has been shown also for pancreatic cancer cell lines in the preclinical setting, is likely to contribute to an increase in local control, and perhaps in OS. Early data from Japanese centers have shown promising results. In conclusion, this is the first trial to evaluate actively delivered carbon

  15. Effect of monthly vitamin D3 supplementation in healthy adults on adverse effects of earthquakes: randomised controlled trial.

    Science.gov (United States)

    Slow, Sandy; Florkowski, Christopher M; Chambers, Stephen T; Priest, Patricia C; Stewart, Alistair W; Jennings, Lance C; Livesey, John H; Camargo, Carlos A; Scragg, Robert; Murdoch, David R

    2014-12-15

    To determine whether supplementation with vitamin D improves resilience to the adverse effects of earthquakes. Opportunistic addition to an established randomised double blind placebo controlled trial. Christchurch, New Zealand, where a prolonged series of catastrophic earthquakes beginning on 4 September 2010 occurred, which caused widespread destruction, fatalities, and extensive psychological damage. 322 healthy adults (241 women; 81 men) aged 18-67 who were already participating in the vitamin D and acute respiratory infections study (VIDARIS) between February 2010 and November 2011. Participants were randomised to receive an oral dose of either 200,000 IU vitamin D3 monthly for two months then 100,000 IU monthly (n=161) or placebo (n=161) for a total of 18 months. This is a post hoc analysis from the previously published VIDARIS trial. The primary endpoint in the current analysis was the self reported effects and overall adverse impact of the Christchurch earthquakes as assessed by questionnaire four months after the most destructive earthquake on 22 February 2011, which was used as the index event. The secondary end point was the number of "psychological" adverse events that participants reported at their usual monthly appointments as part of the original VIDARIS trial. 308 participants completed the earthquake impact questionnaire (n=152 in the vitamin D group and 156 in the placebo group). There was no significant difference in the number of self reported adverse effects between those receiving vitamin D supplementation and those receiving placebo. There was also no difference in the overall adverse impact score between treatment groups (χ(2) P=0.44). The exception was that those in the vitamin D group experienced more adverse effects on family relationships (22% v 13%; χ(2) P=0.03). The number of psychological adverse events-such as fatigue, stress, anxiety, and insomnia-that participants reported at their usual monthly appointments was significantly

  16. Tomo3D 2.0--exploitation of advanced vector extensions (AVX) for 3D reconstruction.

    Science.gov (United States)

    Agulleiro, Jose-Ignacio; Fernandez, Jose-Jesus

    2015-02-01

    Tomo3D is a program for fast tomographic reconstruction on multicore computers. Its high speed stems from code optimization, vectorization with Streaming SIMD Extensions (SSE), multithreading and optimization of disk access. Recently, Advanced Vector eXtensions (AVX) have been introduced in the x86 processor architecture. Compared to SSE, AVX double the number of simultaneous operations, thus pointing to a potential twofold gain in speed. However, in practice, achieving this potential is extremely difficult. Here, we provide a technical description and an assessment of the optimizations included in Tomo3D to take advantage of AVX instructions. Tomo3D 2.0 allows huge reconstructions to be calculated in standard computers in a matter of minutes. Thus, it will be a valuable tool for electron tomography studies with increasing resolution needs. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. The integrated code system CASCADE-3D for advanced core design and safety analysis

    International Nuclear Information System (INIS)

    Neufert, A.; Van de Velde, A.

    1999-01-01

    The new program system CASCADE-3D (Core Analysis and Safety Codes for Advanced Design Evaluation) links some of Siemens advanced code packages for in-core fuel management and accident analysis: SAV95, PANBOX/COBRA and RELAP5. Consequently by using CASCADE-3D the potential of modern fuel assemblies and in-core fuel management strategies can be much better utilized because safety margins which had been reduced due to conservative methods are now predicted more accurately. By this innovative code system the customers can now take full advantage of the recent progress in fuel assembly design and in-core fuel management.(author)

  18. Primary ICD-therapy in patients with advanced heart failure: selection strategies and future trials.

    Science.gov (United States)

    Frankenstein, Lutz; Zugck, Christian; Nelles, Manfred; Schellberg, Dieter; Remppis, Andrew; Katus, Hugo

    2008-09-01

    For allocation of primary ICD-therapy, a possible lower limit of inclusion criteria--defining overly advanced heart failure--is less well investigated. Also, a multi-variable approach to stratification beyond ejection fraction (LVEF) appears warranted. We examined whether adding a selection limit of peak VO(2) trials based on real-life data for this high risk cohort. In our prospective clinical registry 1,926 patients with systolic CHF were recruited consecutively since 1994. Of these patients, 292 met the selection criteria described above. The mean age was 57.6 +/- 9.5 years, 83% were male, 37% had ischemic cardiomyopathy and 28% received primary ICD-therapy. All cause mortality was considered as end point. Median follow-up was 45 (18-86) months. ICD was not a significant predictor of outcome either for the entire population, or grouped according to aetiology of CHF. Still, 3-year mortality was 15% (ICD-patients) Vs. 28% (non-ICD-patients); P = 0.05; under combination medical therapy. Inversely, in ICD-patients medical combination therapy conveyed a significant survival benefit (P < 0.001). Consequently, the number-needed-to-treat was eight under combination therapy and the size estimate amounts to 300 patients for a prospective trial in this cohort. A cut-off of LVEF results indicate the need for a specific randomized trial in this cohort. The according mortality data and a size estimate are provided.

  19. Serum 25-hydroxyvitamin D and mental health in young Australian women: Results from the Safe-D study.

    Science.gov (United States)

    Callegari, Emma T; Reavley, Nicola; Gorelik, Alexandra; Garland, Suzanne M; Wark, John D

    2017-12-15

    While there is evidence linking vitamin D status with mood, this association and its clinical significance remain uncertain. Moreover, few studies have focused on young, community-dwelling females. The Safe-D study examined the association between serum 25-hydroxyvitamin D (25OHD) levels and mental health in young women. Participants completed an online questionnaire, wore a UV dosimeter to measure personal sun exposure and underwent a comprehensive health assessment. Serum 25OHD was measured by liquid chromatography-tandem mass spectrometry in 353 healthy women aged 16-25 years, living in Victoria, Australia. Mental health measures included: Patient Health Questionnaire (PHQ-9), 7-item Generalized Anxiety Disorder Scale (GAD-7), Kessler psychological distress scale (K10) and 12-item short-form health survey (SF-12), plus any self-reported mental disorder diagnoses or medication use. The prevalence of self-reported mental disorder was 26% and of vitamin D deficiency 27%. The median (Q1, Q3) scores for the PHQ-9, GAD-7, K10 and SF-12 MCS were 6 (3, 9), 5 (2, 8), 19 (15, 25) and 43 (34, 49), respectively. Serum 25OHD levels were not associated with mental health scores. Vitamin D status was not associated with a reported diagnosis of depression or anxiety. There was a low prevalence of severe vitamin D deficiency and mental health symptoms, which may reduce study power. Our findings do not support an association between serum 25OHD levels and mental health status in young women. Longitudinal studies and randomized clinical trials investigating vitamin D and mood in young women are needed to confirm and extend these results. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. A cluster randomized controlled trial on the effects and costs of advance care planning in elderly care: study protocol

    NARCIS (Netherlands)

    I.J. Korfage; B.J. Hammes; J. Severijnen; S. Polinder; A. van der Heide; A. Overbeek; F.E. Witkamp; E. Hansen - van der Meer; L.J. Jabbarian; P. Billekens; S.J. Swart; J.A.C. Rietjens

    2015-01-01

    Abstract Background: Currently, health care and medical decision-making at the end of life for older people are often insufficiently patient-centred. In this trial we study the effects of Advance Care Planning (ACP), a formalised process of timely communication about care preferences at the end of

  1. A cluster randomized controlled trial on the effects and costs of advance care planning in elderly care: Study protocol

    NARCIS (Netherlands)

    I.J. Korfage (Ida); J.A.C. Rietjens (Judith); A. Overbeek (Anouk); L.J. Jabbarian (Lea J.); P. Billekens (Pascalle); B.J. Hammes (Bernard J.); E. Hansen-Van Der Meer (Ellen); S. Polinder (Suzanne); J. Severijnen (Johan); S.J. Swart (Siebe); F.E. Witkamp (Frederika); A. van der Heide (Agnes)

    2015-01-01

    textabstractBackground: Currently, health care and medical decision-making at the end of life for older people are often insufficiently patient-centred. In this trial we study the effects of Advance Care Planning (ACP), a formalised process of timely communication about care preferences at the end

  2. Weekly oxaliplatin, 5-fluorouracil and folinic acid (OXALF) as first-line chemotherapy for elderly patients with advanced gastric cancer: results of a phase II trial

    International Nuclear Information System (INIS)

    Santini, D; Vincenzi, B; Russo, A; Caraglia, M; Virzi, V; Cascinu, S; Tonini, G; Graziano, F; Catalano, V; Di Seri, M; Testa, E; Baldelli, AM; Giordani, P; La Cesa, A; Spalletta, B

    2006-01-01

    Elderly patients have been often excluded from or underrepresented in the study populations of combination chemotherapy trials. The primary end point of this study was to determine the response rate and the toxicity of the weekly oxaliplatin, 5-fluorouracil and folinic acid (OXALF) regimen in elderly patients with advanced gastric cancer. The secondary objective was to measure the time to disease progression and the survival time. Chemotherapy-naive patients with advanced gastric cancer aged 70 or older were considered eligible for study entry. Patients received weekly oxaliplatin 40 mg/m2, fluorouracil 500 mg/m2 and folinic acid 250 mg/m2. All drugs were given intravenously on a day-1 schedule. A total of 42 elderly patients were enrolled. Median age was 73 years and all patients had metastatic disease. The response rate according to RECIST criteria was 45.2% (95% CIs: 30%–56%) with two complete responses, 17 partial responses, 13 stable diseases and 10 progressions, for an overall tumor rate control of 76.2% (32 patients). Toxicity was generally mild and only three patients discontinued treatment because of treatment related adverse events. The most common treatment-related grade 3/4 adverse events were fatigue (7.1%), diarrhoea (4.8%), mucositis (2.4%), neurotoxicity (2.4%) and neutropenia (4.8%). The median response duration was 5.3 months (95% CIs: 2.13 – 7.34), the median time to disease progression was 5.0 months (95% CIs: 3.75 – 6.25) and the median survival time was 9.0 months (95% CIs: 6.18 – 11.82). OXALF represents an active and well-tolerated treatment modality for elderly patients with locally advanced and metastatic gastric cancer

  3. Health-Related Quality of Life in SCALOP, a Randomized Phase 2 Trial Comparing Chemoradiation Therapy Regimens in Locally Advanced Pancreatic Cancer

    International Nuclear Information System (INIS)

    Hurt, Christopher N.; Mukherjee, Somnath; Bridgewater, John; Falk, Stephen; Crosby, Tom; McDonald, Alec; Joseph, George; Staffurth, John; Abrams, Ross A.; Blazeby, Jane M.; Bridges, Sarah; Dutton, Peter; Griffiths, Gareth; Maughan, Tim; Johnson, Colin

    2015-01-01

    Purpose: Chemoradiation therapy (CRT) for patients with locally advanced pancreatic cancer (LAPC) provides survival benefits but may result in considerable toxicity. Health-related quality of life (HRQL) measurements during CRT have not been widely reported. This paper reports HRQL data from the Selective Chemoradiation in Advanced Localised Pancreatic Cancer (SCALOP) trial, including validation of the QLQ-PAN26 tool in CRT. Methods and Materials: Patients with locally advanced, inoperable, nonmetastatic carcinoma of the pancreas were eligible. Following 12 weeks of induction gemcitabine plus capecitabine (GEMCAP) chemotherapy, patients with stable and responding disease were randomized to a further cycle of GEMCAP followed by capecitabine- or gemcitabine-based CRT. HRQL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Pancreatic Cancer module (PAN26). Results: A total of 114 patients from 28 UK centers were registered and 74 patients randomized. There was improvement in the majority of HRQL scales during induction chemotherapy. Patients with significant deterioration in fatigue, appetite loss, and gastrointestinal symptoms during CRT recovered within 3 weeks following CRT. Differences in changes in HRQL scores between trial arms rarely reached statistical significance; however, where they did, they favored capecitabine therapy. PAN26 scales had good internal consistency and were able to distinguish between subgroups of patients experiencing toxicity. Conclusions: Although there is deterioration in HRQL following CRT, this resolves within 3 weeks. HRQL data support the use of capecitabine- over gemcitabine-based chemoradiation. The QLQ-PAN26 is a reliable and valid tool for use in patients receiving CRT.

  4. Health-Related Quality of Life in SCALOP, a Randomized Phase 2 Trial Comparing Chemoradiation Therapy Regimens in Locally Advanced Pancreatic Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Hurt, Christopher N., E-mail: hurtcn@cardiff.ac.uk [Wales Cancer Trials Unit, College of Biomedical and Life Sciences, Cardiff University, Cardiff, Wales (United Kingdom); Mukherjee, Somnath [Cancer Research UK/MRC Oxford Institute for Radiation Oncology, Oxford University, NIHR Biomedical Research, Oxford (United Kingdom); Bridgewater, John [UCL Cancer Institute, London (United Kingdom); Falk, Stephen [Bristol Haematology and Oncology Centre, Bristol (United Kingdom); Crosby, Tom [Velindre Cancer Centre, Velindre Hospital, Cardiff, Wales (United Kingdom); McDonald, Alec [Beatson West of Scotland Cancer Centre, Glasgow, Scotland (United Kingdom); Joseph, George [Velindre Cancer Centre, Velindre Hospital, Cardiff, Wales (United Kingdom); Staffurth, John [Institute of Cancer and Genetics, Cardiff University, Cardiff, Wales (United Kingdom); Abrams, Ross A. [Department of Radiation Oncology, Rush University Medical Center, Chicago, Illinois (United States); Blazeby, Jane M. [Division of Surgery, Head and Neck, University Hospitals Bristol National Health Service Foundation Trust, Bristol and School of Social and Community Medicine, University of Bristol, Bristol (United Kingdom); Bridges, Sarah [Wales Cancer Trials Unit, College of Biomedical and Life Sciences, Cardiff University, Cardiff, Wales (United Kingdom); Dutton, Peter [Centre for Statistics in Medicine, University of Oxford, Oxford (United Kingdom); Griffiths, Gareth [Southampton Clinical Trials Unit, Faculty of Medicine, Southampton University, Southampton General Hospital, Southampton (United Kingdom); Maughan, Tim [Cancer Research UK/MRC Oxford Institute for Radiation Oncology, Oxford University, NIHR Biomedical Research, Oxford (United Kingdom); Johnson, Colin [University Surgical Unit, Faculty of Medicine, University Hospital Southampton, Southampton (United Kingdom)

    2015-11-15

    Purpose: Chemoradiation therapy (CRT) for patients with locally advanced pancreatic cancer (LAPC) provides survival benefits but may result in considerable toxicity. Health-related quality of life (HRQL) measurements during CRT have not been widely reported. This paper reports HRQL data from the Selective Chemoradiation in Advanced Localised Pancreatic Cancer (SCALOP) trial, including validation of the QLQ-PAN26 tool in CRT. Methods and Materials: Patients with locally advanced, inoperable, nonmetastatic carcinoma of the pancreas were eligible. Following 12 weeks of induction gemcitabine plus capecitabine (GEMCAP) chemotherapy, patients with stable and responding disease were randomized to a further cycle of GEMCAP followed by capecitabine- or gemcitabine-based CRT. HRQL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Pancreatic Cancer module (PAN26). Results: A total of 114 patients from 28 UK centers were registered and 74 patients randomized. There was improvement in the majority of HRQL scales during induction chemotherapy. Patients with significant deterioration in fatigue, appetite loss, and gastrointestinal symptoms during CRT recovered within 3 weeks following CRT. Differences in changes in HRQL scores between trial arms rarely reached statistical significance; however, where they did, they favored capecitabine therapy. PAN26 scales had good internal consistency and were able to distinguish between subgroups of patients experiencing toxicity. Conclusions: Although there is deterioration in HRQL following CRT, this resolves within 3 weeks. HRQL data support the use of capecitabine- over gemcitabine-based chemoradiation. The QLQ-PAN26 is a reliable and valid tool for use in patients receiving CRT.

  5. TFTR D-T results

    International Nuclear Information System (INIS)

    Meade, D.M.

    1994-01-01

    Temperatures, densities and confinement of deuterium plasmas confined in tokamaks have been achieved within the last decade that are approaching those required for a D-T reactor. As a result, the unique phenomena present in a D-T reactor plasma (D-T plasma confinement, alpha confinement, alpha heating and possible alpha driven instabilities) can now be studied in the laboratory. Recent experiments on the Tokamak Fusion Test Reactor (TFTR) have been the first magnetic fusion experiments to study plasmas with reactor fuel concentrations of tritium. The injection of ∼ 20 MW of tritium and 14 MW of deuterium neutral beams into the TFTR produced a plasma with a T/D density ratio of ∼1 and yielded a maximum fusion power of ∼ 9.2 MW. The fusion power density in the core of the plasma was ∼ 1.8 MW m -3 approximating that expected in a D-T fusion reactor. A TFTR plasma with T/D density ratio of ∼ 1 was found to have ∼ 20% higher energy confinement time than a comparable D plasma, indicating a confinement scaling with average ion mass, A, of τ E ∼ A 0.6 . The core ion temperature increased from 30 keV to 37 keV due to a 35% improvement of ion thermal conductivity. Using the electron thermal conductivity from a comparable deuterium plasma, about 50% of the electron temperature increase from 9 keV to 10.6 keV can be attributed to electron heating by the alpha particles. The ∼ 5% loss of alpha particles, as observed on detectors near the bottom edge of the plasma, was consistent with classical first orbit loss without anomalous effects. Initial measurements have been made of the confined energetic alphas and the resultant alpha ash density. At fusion power levels of 7.5 MW, fluctuations at the Toroidal Alfven Eigenmode frequency were observed by the fluctuation diagnostics. However, no additional alpha loss due to the fluctuations was observed

  6. Advanced Rooftop Control (ARC) Retrofit: Field-Test Results

    Energy Technology Data Exchange (ETDEWEB)

    Wang, Weimin; Katipamula, Srinivas; Ngo, Hung; Underhill, Ronald M.; Taasevigen, Danny J.; Lutes, Robert G.

    2013-07-31

    The multi-year research study was initiated to find solutions to improve packaged equipment operating efficiency in the field. Pacific Northwest National Laboratory (PNNL), with funding from the U.S. Department of Energy’s (DOE’s) Building Technologies Office (BTO) and Bonneville Power Administration (BPA) conducted this research, development and demonstration (RD&D) study. Packaged equipment with constant speed supply fans is designed to provide ventilation at the design rate at all times when the fan is operating as required by building code. Although there are a number of hours during the day when a building may not be fully occupied or the need for ventilation is lower than designed, the ventilation rate cannot be adjusted easily with a constant speed fan. Therefore, modulating the supply fan in conjunction with demand controlled ventilation (DCV) will not only reduce the coil energy but also reduce the fan energy. The objective of this multi-year research, development and demonstration project was to determine the magnitude of energy savings achievable by retrofitting existing packaged rooftop air conditioners with advanced control strategies not ordinarily used for packaged units. First, through detailed simulation analysis, it was shown that significant energy (between 24% and 35%) and cost savings (38%) from fan, cooling and heating energy consumption could be realized when packaged air conditioning units with gas furnaces are retrofitted with advanced control packages (combining multi-speed fan control, integrated economizer controls and DCV). The simulation analysis also showed significant savings for heat pumps (between 20% and 60%). The simulation analysis was followed by an extensive field test of a retrofittable advanced rooftop unit (RTU) controller.

  7. Pharmaceutical companies' policies on access to trial data, results, and methods: audit study.

    Science.gov (United States)

    Goldacre, Ben; Lane, Síle; Mahtani, Kamal R; Heneghan, Carl; Onakpoya, Igho; Bushfield, Ian; Smeeth, Liam

    2017-07-26

    Objectives  To identify the policies of major pharmaceutical companies on transparency of trials, to extract structured data detailing each companies' commitments, and to assess concordance with ethical and professional guidance. Design  Structured audit. Setting  Pharmaceutical companies, worldwide. Participants  42 pharmaceutical companies. Main outcome measures  Companies' commitments on sharing summary results, clinical study reports (CSRs), individual patient data (IPD), and trial registration, for prospective and retrospective trials. Results  Policies were highly variable. Of 23 companies eligible from the top 25 companies by revenue, 21 (91%) committed to register all trials and 22 (96%) committed to share summary results; however, policies commonly lacked timelines for disclosure, and trials on unlicensed medicines and off-label uses were only included in six (26%). 17 companies (74%) committed to share the summary results of past trials. The median start date for this commitment was 2005. 22 companies (96%) had a policy on sharing CSRs, mostly on request: two committed to share only synopses and only two policies included unlicensed treatments. 22 companies (96%) had a policy to share IPD; 14 included phase IV trials (one included trials on unlicensed medicines and off-label uses). Policies in the exploratory group of smaller companies made fewer transparency commitments. Two companies fell short of industry body commitments on registration, three on summary results. Examples of contradictory and ambiguous language were documented and summarised by theme. 23/42 companies (55%) responded to feedback; 7/1806 scored policy elements were revised in light of feedback from companies (0.4%). Several companies committed to changing policy; some made changes immediately. Conclusions  The commitments made by companies to transparency of trials were highly variable. Other than journal submission for all trials within 12 months, all elements of best practice

  8. 26 CFR 1.149(d)-1A - Limitations on advance refundings.

    Science.gov (United States)

    2010-04-01

    ... savings test. If any separate issue in a multipurpose issue increases the aggregate present value debt service savings on the entire multipurpose issue or reduces the present value debt service losses on that... 26 Internal Revenue 2 2010-04-01 2010-04-01 false Limitations on advance refundings. 1.149(d)-1A...

  9. Airborne Lidar: Advances in Discrete Return Technology for 3D Vegetation Mapping

    Directory of Open Access Journals (Sweden)

    Valerie Ussyshkin

    2011-02-01

    Full Text Available Conventional discrete return airborne lidar systems, used in the commercial sector for efficient generation of high quality spatial data, have been considered for the past decade to be an ideal choice for various mapping applications. Unlike two-dimensional aerial imagery, the elevation component of airborne lidar data provides the ability to represent vertical structure details with very high precision, which is an advantage for many lidar applications focusing on the analysis of elevated features such as 3D vegetation mapping. However, the use of conventional airborne discrete return lidar systems for some of these applications has often been limited, mostly due to relatively coarse vertical resolution and insufficient number of multiple measurements in vertical domain. For this reason, full waveform airborne sensors providing more detailed representation of target vertical structure have often been considered as a preferable choice in some areas of 3D vegetation mapping application, such as forestry research. This paper presents an overview of the specific features of airborne lidar technology concerning 3D mapping applications, particularly vegetation mapping. Certain key performance characteristics of lidar sensors important for the quality of vegetation mapping are discussed and illustrated by the advanced capabilities of the ALTM-Orion, a new discrete return sensor manufactured by Optech Incorporated. It is demonstrated that advanced discrete return sensors with enhanced 3D mapping capabilities can produce data of enhanced quality, which can represent complex structures of vegetation targets at the level of details equivalent in some aspects to the content of full waveform data. It is also shown that recent advances in conventional airborne lidar technology bear the potential to create a new application niche, where high quality dense point clouds, enhanced by fully recorded intensity for multiple returns, may provide sufficient

  10. INTEGATED ADVANCED TOKAMAK OPERATION ON DIII-D

    International Nuclear Information System (INIS)

    WADE, M.R.; MURAKAMI, M.; LUCE, T.C.; FERRON, J.R.; PETTY, C.C.; BRENNEN, D.P.; GAROFALO, A.M.; GREENFIELD, C.M.; HYATT, A.W.; JAYAKUMAR, R.; KINSEY, J.E.; La HAYE, R.J.; LAO, L.L.; LOHR, J.; POLITZER, P.A.; PRATER, R.; STRAIT, E.J.; WATKINS, J.G.

    2002-01-01

    Recent experiments on DIII-D have demonstrated the ability to sustain plasma conditions that integrate and sustain the key ingredients of Advanced Tokamak (AT) operation: high β with 1.5 min min > 2.0, plasmas with β ∼ 2.9% and 90% of the plasma current driven non-inductively have been sustained for nearly 2 s (limited only by the duration of the ECCD pulse). Negative central magnetic shear is produced by the ECCD, leading to the formation of a weak internal transport barrier even in the presence of Type I ELMs. Separate experiments have demonstrated the ability to sustain a steady current density profile using ECCD for periods as long as 1 s with β = 3.3% and > 90% of the current driven non-inductively. In addition, stable operation well above the ideal no-wall β limit has been sustained for several energy confinement times with the duration only limited by resistive relaxation of the current profile to an unstable state. Stability analysis indicates that the experimental β limit depends on the degree to which the no-wall limit can be exceeded and weakly on the actual no-wall limit. Achieving the necessary density levels required for adequate ECCD efficiency requires active divertor exhaust and reducing the wall inventory buildup prior to the high performance phase. Simulation studies indicate that the successful integration of high β operation with current profile control consistent with these experimental results should result in high β, fully non-inductive plasma operation

  11. Advances in animal ecology from 3D ecosystem mapping with LiDAR

    Science.gov (United States)

    Davies, A.; Asner, G. P.

    2015-12-01

    The advent and recent advances of Light Detection and Ranging (LiDAR) have enabled accurate measurement of 3D ecosystem structure. Although the use of LiDAR data is widespread in vegetation science, it has only recently (3D ecosystem structure for animals. We reviewed the studies to date that have used LiDAR in animal ecology, synthesising the insights gained. Structural heterogeneity is most conducive to increased animal richness and abundance, and increased complexity of vertical vegetation structure is more positively influential than traditionally measured canopy cover, which produces mixed results. However, different taxonomic groups interact with a variety of 3D canopy traits and some groups with 3D topography. LiDAR technology can be applied to animal ecology studies in a wide variety of environments to answer an impressive array of questions. Drawing on case studies from vastly different groups, termites and lions, we further demonstrate the applicability of LiDAR and highlight new understanding, ranging from habitat preference to predator-prey interactions, that would not have been possible from studies restricted to field based methods. We conclude with discussion of how future studies will benefit by using LiDAR to consider 3D habitat effects in a wider variety of ecosystems and with more taxa to develop a better understanding of animal dynamics.

  12. WE-G-BRB-00: NIH-Funded Research: Instrumental in the Pursuit of Clinical Trials and Technological Innovations

    International Nuclear Information System (INIS)

    2015-01-01

    Over the past 20 years the NIH has funded individual grants, program projects grants, and clinical trials which have been instrumental in advancing patient care. The ways that each grant mechanism lends itself to the different phases of translating research into clinical practice will be described. Major technological innovations, such as IMRT and proton therapy, have been advanced with R01-type and P01-type funding and will be discussed. Similarly, the role of program project grants in identifying and addressing key hypotheses on the potential of 3D conformal therapy, normal tissue-guided dose escalation and motion management will be described. An overview will be provided regarding how these technological innovations have been applied to multi-institutional NIH-sponsored trials. Finally, the panel will discuss regarding which research questions should be funded by the NIH to inspire the next advances in radiation therapy. Learning Objectives: Understand the different funding mechanisms of the NIH Learn about research advances that have led to innovation in delivery Review achievements due to NIH-funded program project grants in radiotherapy over the past 20 years Understand example advances achieved with multi-institutional clinical trials NIH

  13. Local application of GM-CSF for treatment of chemoirradiation-induced mucositis in patients with advanced carcinoma of the head and neck: results of controlled clinical trial

    International Nuclear Information System (INIS)

    Reichtomann, K.A.

    2002-01-01

    Purpose: the study was designed to assess prospectively the efficacy of GM-CSF (granulocyte-macrophage colony-stimulating factor) mouthwash solution in the management of chemoirradiation induced oral mucositis for head and neck cancer patients. Methods and materials: thirty-five patients with advanced carcinoma of the head and neck were evaluated for mucositis during the first cycle of chemoirradiation therapy. GM-CSF 400 μg in 250 cc of water for 1 h of mouth washing was prescribed. Active comparator was a conventional mucositis therapy combination. The procedure started once mucositis grade 1 (using the WHO grading) was detected. Patients, examined twice a week, were evaluated for oral mucositis and oral infections. Assessment of subjective pain was provided using a visual analogue scale. Blood tests were taken weekly. Results: the results of statistical evaluation of mucositis using the WHO-grading showed no significant differences between the two treatment groups. Local application of GM-CSF significantly reduced subjective pain during the second week of chemoirradiation therapy. Statistical analysis of the leucocytes-, platelet count, haemoglobin level and development of oral infections revealed no significant differences between the two treatment groups. Conclusion: in combined chemoirradiation therapy schemes the RTOG/EORTC toxicity scale should be used. In selected cases of mucositis attended with severe pain, GM-CSF should be observed within the therapeutic considerations. Controlled clinical trials with larger patient population are required to evaluate the role of GM-CSF in this indication. (author)

  14. Randomized trial addressing risk features and time factors of surgery plus radiotherapy in advanced head-and-neck cancer

    International Nuclear Information System (INIS)

    Ang, K. Kian; Trotti, Andy; Brown, Barry W.; Garden, Adam S.; Foote, Robert L.; Morrison, William H.; Geara, Fady B.; Klotch, Douglas W.; Goepfert, Helmuth; Peters, Lester J.

    2001-01-01

    Purpose: A multi-institutional, prospective, randomized trial was undertaken in patients with advanced head-and-neck squamous cell carcinoma to address (1) the validity of using pathologic risk features, established from a previous study, to determine the need for, and dose of, postoperative radiotherapy (PORT); (2) the impact of accelerating PORT using a concomitant boost schedule; and (3) the importance of the overall combined treatment duration on the treatment outcome. Methods and Materials: Of 288 consecutive patients with advanced disease registered preoperatively, 213 fulfilled the trial criteria and went on to receive therapy predicated on a set of pathologic risk features: no PORT for the low-risk group (n=31); 57.6 Gy during 6.5 weeks for the intermediate-risk group (n=31); and, by random assignment, 63 Gy during 5 weeks (n=76) or 7 weeks (n=75) for the high-risk group. Patients were irradiated with standard techniques appropriate to the site of disease and likely areas of spread. The study end points were locoregional control (LRC), survival, and morbidity. Results: Patients with low or intermediate risks had significantly higher LRC and survival rates than those with high-risk features (p=0.003 and p=0.0001, respectively), despite receiving no PORT or lower dose PORT, respectively. For high-risk patients, a trend toward higher LRC and survival rates was noted when PORT was delivered in 5 rather than 7 weeks. A prolonged interval between surgery and PORT in the 7-week schedule was associated with significantly lower LRC (p=0.03) and survival (p=0.01) rates. Consequently, the cumulative duration of combined therapy had a significant impact on the LRC (p=0.005) and survival (p=0.03) rates. A 2-week reduction in the PORT duration by using the concomitant boost technique did not increase the late treatment toxicity. Conclusions: This Phase III trial established the power of risk assessment using pathologic features in determining the need for, and dose of

  15. A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency.

    Science.gov (United States)

    Carpentier, Patrick H; Blaise, Sophie; Satger, Bernadette; Genty, Céline; Rolland, Carole; Roques, Christian; Bosson, Jean-Luc

    2014-02-01

    Apart from compression therapy, physical therapy has scarcely been evaluated in the treatment of chronic venous disorders (CVDs). Spa treatment is a popular way to administer physical therapy for CVDs in France, but its efficacy has not yet been assessed in a large trial. The objective was to assess the efficacy of spa therapy for patients with advanced CVD (CEAP clinical classes C4-C5). This was a single-blind (treatment concealed to the investigators) randomized, multicenter, controlled trial (French spa resorts). Inclusion criteria were primary or post-thrombotic CVD with skin changes but no active ulcer (C4a, C4b, or C5). The treated group had the usual 3-week spa treatment course soon after randomization; the control group had spa treatment after the 1-year comparison period. All patients continued their usual medical care including wearing compression stockings. Treatment consisted of four balneotherapy sessions per day for 6 days a week. Follow-up was performed at 6, 12 and 18 months by independent blinded investigators. The main outcome criterion was the incidence of leg ulcers at 12 months. Secondary criteria were a modified version of the Venous Clinical Severity Score, a visual analog scale for leg symptoms, and the Chronic Venous Insufficiency Questionnaire 2 and EuroQol 5D quality-of-life autoquestionnaires. Four hundred twenty-five subjects were enrolled: 214 in the treatment group (Spa) and 211 in the control group (Ctr); they were similar at baseline regarding their demographic characteristics, the severity of the CVD, and the outcome variables. At 1 year, the incidence of leg ulcers was not statistically different (Spa: +9.3%; 95% confidence interval [CI], +5.6 - +14.3; Ctr: +6.1%; 95% CI, +3.2 - +10.4), whereas the Venous Clinical Severity Score improved significantly in the treatment group (Spa: -1.2; 95% CI, -1.6 - -0.8; Ctr: -0.6; 95% CI, -1.0 - -0.2; P = .04). A significant difference favoring spa treatment was found regarding symptoms after 1

  16. Three graduate students receive Virginia Tech's first AdvanceVT Ph.D. fellowships

    OpenAIRE

    Cox, Clara B.

    2004-01-01

    AdvanceVT, a comprehensive program that promotes and enhances the careers of women in science and engineering, has awarded its first three Ph.D. fellowships as part of an ongoing effort to increase the number of women electing to pursue academic careers.

  17. Report of the evaluation by the Ad Hoc Review Committee on advance science research. Result evaluation, interim evaluation, in-advance evaluation in fiscal year 2003

    International Nuclear Information System (INIS)

    2003-11-01

    The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Advanced Science Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the accomplishments of the research completed in Fiscal Year 2002, the accomplishments of the research started in Fiscal Year 2001, and the adequacy of the programs of the research to be started in Fiscal Year 2004 at Advanced Science Research Center of JAERI. The Ad Hoc Review Committee consisted of nine specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from May to July 2003. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 24, 2003, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on August 4, 2003. This report describes the result of the evaluation by the Ad Hoc Review Committee on Advanced Science Research. (author)

  18. Report of the evaluation by the Ad Hoc Review Committee on Advance Science Research. Result evaluation, interim evaluation, in-advance evaluation in fiscal year 2002

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-11-01

    The Research Evaluation Committee, which consisted of 13 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Advanced Science Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the accomplishments of the research completed in Fiscal Year 2001, the accomplishments of the research started in Fiscal Year 2000, and the adequacy of the programs of the research to be started in Fiscal Year 2003 at Advanced Science Research Center of JAERI. The Ad Hoc Review Committee consisted of eight specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from May to July 2002. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on June 4, 2002, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on August 5, 2002. This report describes the result of the evaluation by the Ad Hoc Review Committee on Advanced Science Research. (author)

  19. Advanced large airway CT imaging in children: evolution from axial to 4-D assessment

    International Nuclear Information System (INIS)

    Lee, Edward Y.; Zucker, Evan J.; Restrepo, Ricardo; Daltro, Pedro; Boiselle, Phillip M.

    2013-01-01

    Continuing advances in multidetector computed tomography (MDCT) technology are revolutionizing the non-invasive evaluation of congenital and acquired large airway disorders in children. For example, the faster scanning time and increased anatomical coverage that are afforded by MDCT are especially beneficial to children. MDCT also provides high-quality multiplanar 2-dimensional (2-D), internal and external volume-rendering 3-dimensional (3-D), and dynamic 4-dimensional (4-D) imaging. These advances have enabled CT to become the primary non-invasive imaging modality of choice for the diagnosis, treatment planning, and follow-up evaluation of various large airway disorders in infants and children. It is thus essential for radiologists to be familiar with safe and effective techniques for performing MDCT and to be able to recognize the characteristic imaging appearances of large airway disorders affecting children. (orig.)

  20. Effects of vitamin D2-fortified bread v. supplementation with vitamin D2 or D3 on serum 25-hydroxyvitamin D metabolites: an 8-week randomised-controlled trial in young adult Finnish women.

    Science.gov (United States)

    Itkonen, Suvi T; Skaffari, Essi; Saaristo, Pilvi; Saarnio, Elisa M; Erkkola, Maijaliisa; Jakobsen, Jette; Cashman, Kevin D; Lamberg-Allardt, Christel

    2016-04-14

    There is a need for food-based solutions for preventing vitamin D deficiency. Vitamin D3 (D3) is mainly used in fortified food products, although the production of vitamin D2 (D2) is more cost-effective, and thus may hold opportunities. We investigated the bioavailability of D2 from UV-irradiated yeast present in bread in an 8-week randomised-controlled trial in healthy 20-37-year-old women (n 33) in Helsinki (60°N) during winter (February-April) 2014. Four study groups were given different study products (placebo pill and regular bread=0 µg D2 or D3/d; D2 supplement and regular bread=25 µg D2/d; D3 supplement and regular bread=25 µg D3/d; and placebo pill and D2-biofortified bread=25 µg D2/d). Serum 25-hydroxyvitamin D2 (S-25(OH)D2) and serum 25-hydroxyvitamin D3 (S-25(OH)D3) concentrations were measured at baseline, midpoint and end point. The mean baseline total serum 25-hydroxyvitamin D (S-25(OH)D=S-25(OH)D2+S-25(OH)D3) concentration was 65·1 nmol/l. In repeated-measures ANCOVA (adjusted for baseline S-25(OH)D as total/D2/D3), D2-bread did not affect total S-25(OH)D (P=0·707) or S-25(OH)D3 (P=0·490), but increased S-25(OH)D2 compared with placebo (PD2 supplement was more effective than bread in increasing S-25(OH)D2 (PD2 and D3 supplementation increased total S-25(OH)D compared with placebo (P=0·030 and P=0·001, respectively), but D2 supplementation resulted in lower S-25(OH)D3 (PD2 from UV-irradiated yeast in bread was not bioavailable in humans. Our results support the evidence that D2 is less potent in increasing total S-25(OH)D concentrations than D3, also indicating a decrease in the percentage contribution of S-25(OH)D3 to the total vitamin D pool.

  1. Pooled analysis of phase II trials evaluating weekly or conventional cisplatin as first-line therapy for advanced urothelial carcinoma

    DEFF Research Database (Denmark)

    Maughan, Benjamin L; Agarwal, Neeraj; Hussain, Syed A

    2013-01-01

    Weekly gemcitabine with GC every 3-4 weeks is considered conventional first-line chemotherapy for advanced urothelial carcinoma (UC). Weekly split-dose cisplatin with wGC might be less toxic and have similar activity, but has not been compared with GC. We pooled published phase II trials of GC an...

  2. Long-Term Improvement in Treatment Outcome After Radiotherapy and Hyperthermia in Locoregionally Advanced Cervix Cancer: An Update of the Dutch Deep Hyperthermia Trial

    International Nuclear Information System (INIS)

    Franckena, Martine; Stalpers, Lukas J.A.; Koper, Peter C.M.; Wiggenraad, Ruud G.J.; Hoogenraad, Wim J.; Dijk, Jan D.P. van; Warlam-Rodenhuis, Carla C.; Jobsen, Jan J.; Rhoon, Gerard C. van; Zee, Jacoba van der

    2008-01-01

    Purpose: The local failure rate in patients with locoregionally advanced cervical cancer is 41-72% after radiotherapy (RT) alone, whereas local control is a prerequisite for cure. The Dutch Deep Hyperthermia Trial showed that combining RT with hyperthermia (HT) improved 3-year local control rates of 41-61%, as we reported earlier. In this study, we evaluate long-term results of the Dutch Deep Hyperthermia Trial after 12 years of follow-up. Methods and Materials: From 1990 to 1996, a total of 114 women with locoregionally advanced cervical carcinoma were randomly assigned to RT or RT + HT. The RT was applied to a median total dose of 68 Gy. The HT was given once weekly. The primary end point was local control. Secondary end points were overall survival and late toxicity. Results: At the 12-year follow-up, local control remained better in the RT + HT group (37% vs. 56%; p = 0.01). Survival was persistently better after 12 years: 20% (RT) and 37% (RT + HT; p = 0.03). World Health Organization (WHO) performance status was a significant prognostic factor for local control. The WHO performance status, International Federation of Gynaecology and Obstetrics (FIGO) stage, and tumor diameter were significant for survival. The benefit of HT remained significant after correction for these factors. European Organization for Research and Treatment of Cancer Grade 3 or higher radiation-induced late toxicities were similar in both groups. Conclusions: For locoregionally advanced cervical cancer, the addition of HT to RT resulted in long-term major improvement in local control and survival without increasing late toxicity. This combined treatment should be considered for patients who are unfit to receive chemotherapy. For other patients, the optimal treatment strategy is the subject of ongoing research

  3. Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results.

    Science.gov (United States)

    Zahnert, Thomas; Löwenheim, Hubert; Beutner, Dirk; Hagen, Rudolf; Ernst, Arneborg; Pau, Hans-Wilhelm; Zehlicke, Thorsten; Kühne, Hilke; Friese, Natascha; Tropitzsch, Anke; Lüers, Jan-Christoffer; Mlynski, Robert; Todt, Ingo; Hüttenbrink, Karl-Bernd

    2016-01-01

    To evaluate the safety and effectiveness of round window (RW), oval window (OW), CliP and Bell couplers for use with an active middle ear implant. This is a multicenter, long-term, prospective trial with consecutive enrollment, involving 6 university hospitals in Germany. Bone conduction, air conduction, implant-aided warble-tone thresholds and Freiburger monosyllable word recognition scores were compared with unaided preimplantation results in 28 moderate-to-profound hearing-impaired patients after 12 months of follow-up. All patients had previously undergone failed reconstruction surgeries (up to 5 or more). In a subset of patients, additional speech tests at 12 months postoperatively were used to compare the aided with the unaided condition after implantation with the processor switched off. An established quality-of-life questionnaire for hearing aids was used to determine patient satisfaction. Postoperative bone conduction remained stable. Mean functional gain for all couplers was 37 dB HL (RW = 42 dB, OW = 35 dB, Bell = 38 dB, CliP = 27 dB). The mean postoperative Freiburger monosyllable score was 71% at 65 dB SPL. The postimplantation mean SRT50 (speech reception in quiet for 50% understanding of words in sentences) improved on average by 23 dB over unaided testing and signal-to-noise ratios also improved in all patients. The International Outcome Inventory for Hearing Aids (IOI-HA)quality-of-life questionnaire was scored very positively by all patients. A significant improvement was seen with all couplers, and patients were satisfied with the device at 12 months postoperatively. These results demonstrate that an active implant is an advantage in achieving good hearing benefit in patients with prior failed reconstruction surgery. © 2016 S. Karger AG, Basel.

  4. A randomized clinical trial in vitamin D-deficient adults comparing replenishment with oral vitamin D3 with narrow-band UV type B light: effects on cholesterol and the transcriptional profiles of skin and blood.

    Science.gov (United States)

    Ponda, Manish P; Liang, Yupu; Kim, Jaehwan; Hutt, Richard; Dowd, Kathleen; Gilleaudeau, Patricia; Sullivan-Whalen, Mary M; Rodrick, Tori; Kim, Dong Joo; Barash, Irina; Lowes, Michelle A; Breslow, Jan L

    2017-05-01

    Background: Vitamin D deficiency, defined as a serum 25-hydroxyvitamin D [25(OH)D] concentration light. Objective: We tested the hypothesis that, in vitamin D-deficient adults, the replenishment of vitamin D with UVB exposure would lower LDL-cholesterol concentrations compared with the effect of oral vitamin D 3 supplementation. Design: We performed a randomized clinical trial in vitamin D-deficient adults and compared vitamin D replenishment between subjects who received oral vitamin D 3 ( n = 60) and those who received narrow-band UVB exposure ( n = 58) ≤6 mo. Results: There was no difference in the change from baseline LDL-cholesterol concentrations between oral vitamin D 3 and UVB groups (difference in median of oral vitamin D 3 minus that of UVB: 1.5 mg/dL; 95% CI: -5.0, 7.0 mg/dL). There were also no differences within groups or between groups for changes in total or HDL cholesterol or triglycerides. Transcriptional profiling of skin and blood, however, revealed significant upregulation of immune pathway signaling with oral vitamin D 3 but significant downregulation with UVB. Conclusions: Correcting vitamin D deficiency with either oral vitamin D 3 or UVB does not improve the lipid profile. Beyond cholesterol, these 2 modalities of raising 25(OH)D have disparate effects on gene transcription. This trial was registered at clinicaltrials.gov as NCT01688102. © 2017 American Society for Nutrition.

  5. Rationale and Design of Khuzestan Vitamin D Deficiency Screening Program in Pregnancy: A Stratified Randomized Vitamin D Supplementation Controlled Trial.

    Science.gov (United States)

    Rostami, Maryam; Ramezani Tehrani, Fahimeh; Simbar, Masoumeh; Hosseinpanah, Farhad; Alavi Majd, Hamid

    2017-04-07

    according to the intention-to-treat principle. Recruitment commenced in July, 2014, and as estimated, nearly 3.5 years is needed to complete the study. Results of this study will (1) provide reliable information regarding the prevalence of vitamin D deficiency during pregnancy using universal vitamin D screening approach and (2) determine the beneficial effects of universal screening and compare the various treatment protocols in terms of pregnancy outcomes. Since vitamin D deficiency is a prevalent disorder in pregnancy among Iranian population, this study will ensure creation of reliable evidence-based findings and will enable clinicians to better evaluate and treat vitamin D deficient pregnant women. International Standard Randomized Controlled Trial Number (ISRCTN): 2014102519660N1; http://www.irct.ir/searchresult.php?keyword=&id=19660&number=1&prt=7805&total=10&m=1 (Archived by WebCite at http://www.webcitation.org/6p3lkqFdV). ©Maryam Rostami, Fahimeh Ramezani Tehrani, Masoumeh Simbar, Farhad Hosseinpanah, Hamid Alavi Majd. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 07.04.2017.

  6. Effect of vitamin D supplementation on the level of circulating high-sensitivity C-reactive protein: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Chen, Neng; Wan, Zhongxiao; Han, Shu-Fen; Li, Bing-Yan; Zhang, Zeng-Li; Qin, Li-Qiang

    2014-06-10

    Vitamin D might elicit protective effects against cardiovascular disease by decreasing the level of circulating high-sensitivity C-reactive protein (hs-CRP), an inflammatory marker. Thus, we conducted a meta-analysis of randomized controlled trials to evaluate the association of vitamin D supplementation with circulating hs-CRP level. A systematic literature search was conducted in September 2013 (updated in February 2014) via PubMed, Web of Science, and Cochrane library to identify eligible studies. Either a fixed-effects or a random-effects model was used to calculate pooled effects. The results of the meta-analysis of 10 trials involving a total of 924 participants showed that vitamin D supplementation significantly decreased the circulating hs-CRP level by 1.08 mg/L (95% CI, -2.13, -0.03), with the evidence of heterogeneity. Subgroup analysis suggested a higher reduction of 2.21 mg/L (95% CI, -3.50, -0.92) among participants with baseline hs-CRP level ≥5 mg/L. Meta-regression analysis further revealed that baseline hs-CRP level, supplemental dose of vitamin D and intervention duration together may be attributed to the heterogeneity across studies. In summary, vitamin D supplementation is beneficial for the reduction of circulating hs-CRP. However, the result should be interpreted with caution because of the evidence of heterogeneity.

  7. Large volume unresectable locally advanced non-small cell lung cancer: acute toxicity and initial outcome results with rapid arc

    Directory of Open Access Journals (Sweden)

    Fogliata Antonella

    2010-10-01

    Full Text Available Abstract Background To report acute toxicity, initial outcome results and planning therapeutic parameters in radiation treatment of advanced lung cancer (stage III with volumetric modulated arcs using RapidArc (RA. Methods Twenty-four consecutive patients were treated with RA. All showed locally advanced non-small cell lung cancer with stage IIIA-IIIB and with large volumes (GTV:299 ± 175 cm3, PTV:818 ± 206 cm3. Dose prescription was 66Gy in 33 fractions to mean PTV. Delivery was performed with two partial arcs with a 6 MV photon beam. Results From a dosimetric point of view, RA allowed us to respect most planning objectives on target volumes and organs at risk. In particular: for GTV D1% = 105.6 ± 1.7%, D99% = 96.7 ± 1.8%, D5%-D95% = 6.3 ± 1.4%; contra-lateral lung mean dose resulted in 13.7 ± 3.9Gy, for spinal cord D1% = 39.5 ± 4.0Gy, for heart V45Gy = 9.0 ± 7.0Gy, for esophagus D1% = 67.4 ± 2.2Gy. Delivery time was 133 ± 7s. At three months partial remission > 50% was observed in 56% of patients. Acute toxicities at 3 months showed 91% with grade 1 and 9% with grade 2 esophageal toxicity; 18% presented grade 1 and 9% with grade 2 pneumonia; no grade 3 acute toxicity was observed. The short follow-up does not allow assessment of local control and progression free survival. Conclusions RA proved to be a safe and advantageous treatment modality for NSCLC with large volumes. Long term observation of patients is needed to assess outcome and late toxicity.

  8. Advances in 3D electromagnetic finite element modeling

    International Nuclear Information System (INIS)

    Nelson, E.M.

    1997-01-01

    Numerous advances in electromagnetic finite element analysis (FEA) have been made in recent years. The maturity of frequency domain and eigenmode calculations, and the growth of time domain applications is briefly reviewed. A high accuracy 3D electromagnetic finite element field solver employing quadratic hexahedral elements and quadratic mixed-order one-form basis functions will also be described. The solver is based on an object-oriented C++ class library. Test cases demonstrate that frequency errors less than 10 ppm can be achieved using modest workstations, and that the solutions have no contamination from spurious modes. The role of differential geometry and geometrical physics in finite element analysis is also discussed

  9. Utility of preoperative ferumoxtran-10 MRI to evaluate retroperitoneal lymph node metastasis in advanced cervical cancer: Results of ACRIN 6671/GOG 0233

    International Nuclear Information System (INIS)

    Atri, Mostafa; Zhang, Zheng; Marques, Helga; Gorelick, Jeremy; Harisinghani, Mukesh; Sohaib, Aslam; Koh, Dow-Mu; Raman, Steven; Gee, Michael; Choi, Haesun; Landrum, Lisa; Mannel, Robert; Chuang, Linus; Yu, Jian Qin; McCourt, Carolyn Kay; Gold, Michael

    2014-01-01

    •We evaluated the added value of a USPIO agent (Ferumoxtran-10) to MRI evaluation of LN metastasis in loco-regionally advanced cervical cancer in a multicenter trial.•There was no significant difference in the accuracy of f-10 MRI as compared to standard MRI to detect LN metastasis in advanced cervical cancer (P > 0.05).•F-10 MRI increased sensitivity of MRI to detect metastasis in small (<8 mm) LNs but at the expense of lower specificity.•Mean size of the largest metastatic focus in the LN on pathology was 13.7 mm in the abdomen and 18.8 mm in the pelvis (P = 0.018). We evaluated the added value of a USPIO agent (Ferumoxtran-10) to MRI evaluation of LN metastasis in loco-regionally advanced cervical cancer in a multicenter trial. There was no significant difference in the accuracy of f-10 MRI as compared to standard MRI to detect LN metastasis in advanced cervical cancer (P > 0.05). F-10 MRI increased sensitivity of MRI to detect metastasis in small (<8 mm) LNs but at the expense of lower specificity. Mean size of the largest metastatic focus in the LN on pathology was 13.7 mm in the abdomen and 18.8 mm in the pelvis (P = 0.018). To assess if ferumoxtran-10 (f-10) improves accuracy of MRI to detect lymph node (LN) metastasis in advanced cervical cancer. F-10 MRI component of an IRB approved HIPAA compliant ACRIN/GOG trial was analyzed. Patients underwent f-10 MRI followed by extra-peritoneal or laparoscopic pelvic and abdominal lymphadenectomy. F-10-sensitive sequences were T2* GRE sequences with TE of 12 and 21. Seven independent blinded readers reviewed f-10-insensitive sequences and all sequences in different sessions. Region correlations were performed between pathology and MRI for eight abdomen and pelvis regions. Sensitivity and specificity were calculated at participant level. Reference standard is based on pathology result of surgically removed LNs. Among 43 women enrolled in the trial between September 2007 and November 2009, 33 women (mean age 49

  10. Incentives to strengthen international co-operation in R and D for advanced nuclear power technology

    International Nuclear Information System (INIS)

    Balthesen, E.; Bakunyaev, A.D.; Gibson, I.H.; Hosemann, J.P.; Tavoni, R.; Versteegh, A.M.

    1993-01-01

    This paper is concerned with the need for International Co-operation in R and D for Advanced Reactors in order to maintain options for the future deployment of nuclear power against the current background of declining R and D capability in Europe

  11. Vitamin D-Fortified Bread Is as Effective as Supplement in Improving Vitamin D Status: A Randomized Clinical Trial.

    Science.gov (United States)

    Nikooyeh, Bahareh; Neyestani, Tirang R; Zahedirad, Maliheh; Mohammadi, Mehrdad; Hosseini, S Hedayat; Abdollahi, Zahra; Salehi, Foroozan; Mirzay Razaz, Jalaledin; Shariatzadeh, Nastaran; Kalayi, Ali; Lotfollahi, Neda; Maleki, Mohammad-Reza

    2016-06-01

    Bread can potentially be a suitable vehicle for fortification with vitamin D. This study was undertaken to evaluate the following: 1) the bioavailability of vitamin D from the fortified Iranian bread and 2) the possible effects of daily consumption of the fortified bread on certain health aspects. This was a randomized, double-blind, placebo-controlled trial conducted over 8 weeks in 90 healthy subjects aged 20-60 years. Subjects were randomly allocated to one of three groups: 1) fortified bread (FP; 50 g bread fortified with 25 μg vitamin D3 plus placebo daily; n = 30); 2) supplement (SP; 50 g plain bread plus 25 μg vitamin D supplement daily; n = 30); and 3) control (CP; 50 g plain bread plus placebo daily; n = 30). Initial and final anthropometric and biochemical assessments were performed. The within-group changes of serum 25-hydroxyvitamin D concentrations were 39.0 ± 22.6 (P bread could be potentially effective in raising circulating 25-hydroxyvitamin D levels of the population to nearly adequate levels.

  12. Supplemental vitamin D and physical performance in COPD: a pilot randomized trial

    Directory of Open Access Journals (Sweden)

    Bjerk SM

    2013-02-01

    Full Text Available Sonja M Bjerk,1 Bradley D Edgington,1 Thomas S Rector,1,2 Ken M Kunisaki1,21University of Minnesota, 2Minneapolis VA Health Care System, Minneapolis, MN, USABackground: Low 25-hydroxyvitamin D (25[OH]D levels, commonly observed in chronic obstructive pulmonary disease (COPD, are associated with muscle weakness in elderly populations, and vitamin D supplementation appears to improve muscle strength and decrease falls in older individuals. We tested the effect of vitamin D supplementation on physical performance in patients with COPD.Methods: Patients were randomized to daily cholecalciferol (2000 IU or placebo for 6 weeks. The primary outcome was the 6-week change in Short Physical Performance Battery (SPPB score. Secondary outcomes included changes in the St George’s Respiratory Questionnaire (SGRQ score, and serum 25(OHD.Results: Thirty-six participants (mean age 68 years, all Caucasian males, mean forced expiratory volume in one second 33% of predicted completed the study. Despite an increase in 25(OHD levels in the intervention arm to a mean of 32.6 ng/mL (versus 22.1 ng/mL in the placebo arm, there was no difference in improvements in either SPPB scores (0.3 point difference; 95% confidence interval -0.8 to 1.5; P = 0.56 or SGRQ scores (2.3 point difference; 95% confidence interval -2.3 to 6.9; P = 0.32.Conclusion: Among patients with severe COPD, 2000 IU of daily vitamin D for 6 weeks increased 25(OHD to a level widely considered as normal. However, compared with placebo, short-term vitamin D supplementation had no discernible effect on a simple measure of physical performance.Keywords: chronic obstructive pulmonary disease, randomized controlled trial, vitamin D, skeletal muscle strength

  13. Fast neutrons in the treatment of head and neck cancers: the results of a multi-centre randomly controlled trial

    International Nuclear Information System (INIS)

    Duncan, W.; Arnott, S.J.; Orr, J.A.; Kerr, G.R.; Schmitt, G.

    1984-01-01

    The results are presented of a multi-centre randomly controlled trial of fast neutron irradiation and mega-voltage X-rays in the treatment of patients with locally advanced squamous cell carcinoma of the head and neck region. No significant difference was observed in local tumour control rates. Salvage surgery was performed in a similar number of patients in the two groups. Late morbidity was also similar in the two treatment groups. Patients in a subgroup with cancer of the larynx treated by photons had a significantly better survival than those in the neutron treated group. (Auth.)

  14. Age of Menopause and Fracture Risk in Post-Menopausal Women Randomized to Calcium + Vitamin D, Hormone Therapy, or the combination: Results from the Women’s Health Initiative Clinical Trials

    Science.gov (United States)

    Sullivan, Shannon D.; Lehman, Amy; Nathan, Nisha K.; Thomson, Cynthia A.; Howard, Barbara V.

    2016-01-01

    OBJECTIVE We previously reported that in the absence of hormone therapy (HT) or calcium/vitamin D (Ca/D) supplementation, earlier menopause age was associated with decreased bone mineral density (BMD) and increased fracture risk in healthy post-menopausal women. Treatment with HT and Ca/D are protective against fractures after menopause. In this analysis, we asked if age of menopause onset alters fracture risk in healthy post-menopausal women receiving HT, Ca/Vit D, or the combination. METHODS Hazard ratios (HR) for any fracture among 21,711 healthy post-menopausal women enrolled in the Women’s Health Initiative Clinical Trial (WHI-CT), who were treated with HT, Ca/Vit D, or HT + Ca/D, and who reported age of non-surgical menopause of menopause menopause 40-49 or ≥50, regardless of treatment intervention [HR (95% CI): menopause menopause menopause age (menopause ages. The effect of menopause age on fracture risk was not altered by any of the treatment interventions (HT, Ca/D, HT+Ca/D), suggesting that early age of menopause is an independent contributor to postmenopausal fracture risk. PMID:27801706

  15. Metronomic chemotherapy in the neoadjuvant setting: results of two parallel feasibility trials (TraQme and TAME) in patients with HER2+ and HER2− locally advanced breast cancer

    International Nuclear Information System (INIS)

    Petry, V.; Gagliato, D.M.; Leal, A.I.C.; Arai, R.J.; Longo, E.; Andrade, F.; Ricci, M.D.; Piato, J.R.; Barroso-Sousa, R.; Hoff, P.M.; Mano, M.S.

    2015-01-01

    Neoadjuvant chemotherapy has practical and theoretical advantages over adjuvant chemotherapy strategy in breast cancer (BC) management. Moreover, metronomic delivery has a more favorable toxicity profile. The present study examined the feasibility of neoadjuvant metronomic chemotherapy in two cohorts [HER2+ (TraQme) and HER2− (TAME)] of locally advanced BC. Twenty patients were prospectively enrolled (TraQme, n=9; TAME, n=11). Both cohorts received weekly paclitaxel at 100 mg/m 2 during 8 weeks followed by weekly doxorubicin at 24 mg/m 2 for 9 weeks in combination with oral cyclophosphamide at 100 mg/day (fixed dose). The HER2+ cohort received weekly trastuzumab. The study was interrupted because of safety issues. Thirty-six percent of patients in the TAME cohort and all patients from the TraQme cohort had stage III BC. Of note, 33% from the TraQme cohort and 66% from the TAME cohort displayed hormone receptor positivity in tumor tissue. The pathological complete response rates were 55% and 18% among patients enrolled in the TraQme and TAME cohorts, respectively. Patients in the TraQme cohort had more advanced BC stages at diagnosis, higher-grade pathological classification, and more tumors lacking hormone receptor expression, compared to the TAME cohort. The toxicity profile was also different. Two patients in the TraQme cohort developed pneumonitis, and in the TAME cohort we observed more hematological toxicity and hand-foot syndrome. The neoadjuvant metronomic chemotherapy regimen evaluated in this trial was highly effective in achieving a tumor response, especially in the HER2+ cohort. Pneumonitis was a serious, unexpected adverse event observed in this group. Further larger and randomized trials are warranted to evaluate the association between metronomic chemotherapy and trastuzumab treatment

  16. Metronomic chemotherapy in the neoadjuvant setting: results of two parallel feasibility trials (TraQme and TAME) in patients with HER2+ and HER2− locally advanced breast cancer

    Energy Technology Data Exchange (ETDEWEB)

    Petry, V.; Gagliato, D.M.; Leal, A.I.C.; Arai, R.J.; Longo, E. [Divisão de Oncologia Médica, Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP (Brazil); Andrade, F. [Núcleo de Mastologia, Hospital Sírio Libanês, São Paulo, SP (Brazil); Ricci, M.D.; Piato, J.R.; Barroso-Sousa, R.; Hoff, P.M.; Mano, M.S. [Divisão de Oncologia Médica, Instituto do Câncer do Estado de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP (Brazil)

    2015-03-06

    Neoadjuvant chemotherapy has practical and theoretical advantages over adjuvant chemotherapy strategy in breast cancer (BC) management. Moreover, metronomic delivery has a more favorable toxicity profile. The present study examined the feasibility of neoadjuvant metronomic chemotherapy in two cohorts [HER2+ (TraQme) and HER2− (TAME)] of locally advanced BC. Twenty patients were prospectively enrolled (TraQme, n=9; TAME, n=11). Both cohorts received weekly paclitaxel at 100 mg/m{sup 2} during 8 weeks followed by weekly doxorubicin at 24 mg/m{sup 2} for 9 weeks in combination with oral cyclophosphamide at 100 mg/day (fixed dose). The HER2+ cohort received weekly trastuzumab. The study was interrupted because of safety issues. Thirty-six percent of patients in the TAME cohort and all patients from the TraQme cohort had stage III BC. Of note, 33% from the TraQme cohort and 66% from the TAME cohort displayed hormone receptor positivity in tumor tissue. The pathological complete response rates were 55% and 18% among patients enrolled in the TraQme and TAME cohorts, respectively. Patients in the TraQme cohort had more advanced BC stages at diagnosis, higher-grade pathological classification, and more tumors lacking hormone receptor expression, compared to the TAME cohort. The toxicity profile was also different. Two patients in the TraQme cohort developed pneumonitis, and in the TAME cohort we observed more hematological toxicity and hand-foot syndrome. The neoadjuvant metronomic chemotherapy regimen evaluated in this trial was highly effective in achieving a tumor response, especially in the HER2+ cohort. Pneumonitis was a serious, unexpected adverse event observed in this group. Further larger and randomized trials are warranted to evaluate the association between metronomic chemotherapy and trastuzumab treatment.

  17. Pomegranate (Punicagranatum juice decreases lipid peroxidation, but has no effect on plasma advanced glycated end-products in adults with type 2 diabetes: a randomized double-blind clinical trial

    Directory of Open Access Journals (Sweden)

    Golbon Sohrab

    2015-09-01

    Full Text Available Introduction: Diabetes mellitus characterized by hyperglycemia could increase oxidative stress and formation of advanced glycated end-products (AGEs, which contribute to diabetic complications. The purpose of this study was to assess the effect of pomegranate juice (PJ containing natural antioxidant on lipid peroxidation and plasma AGEs in patients with type 2 diabetes (T2D. Materials and methods: In a randomized, double-blind, placebo-controlled trial, 44 patients (age range 56±6.8 years, T2D were randomly assigned to one of two groups: group A (PJ, n=22 and group B (Placebo, n=22. At the baseline and the end of 12-week intervention, biochemical markers including fasting plasma glucose, insulin, oxidative stress, and AGE markers including carboxy methyl lysine (CML and pentosidine were assayed. Results: At baseline, there were no significant differences in plasma total antioxidant capacity (TAC levels between the two groups, but malondialdehyde (MDA decreased levels were significantly different (P<0.001. After 12 weeks of intervention, TAC increased (P<0.05 and MDA decreased (P<0.01 in the PJ group when compared with the placebo group. However, no significant differences were observed in plasma concentration of CML and pentosidine between the two groups. Conclusions: The study showed that PJ decreases lipid peroxidation. Therefore, PJ consumption may delay onset of T2D complications related to oxidative stress.

  18. Iterative oscillation results for second-order differential equations with advanced argument

    Directory of Open Access Journals (Sweden)

    Irena Jadlovska

    2017-07-01

    Full Text Available This article concerns the oscillation of solutions to a linear second-order differential equation with advanced argument. Sufficient oscillation conditions involving limit inferior are given which essentially improve known results. We base our technique on the iterative construction of solution estimates and some of the recent ideas developed for first-order advanced differential equations. We demonstrate the advantage of our results on Euler-type advanced equation. Using MATLAB software, a comparison of the effectiveness of newly obtained criteria as well as the necessary iteration length in particular cases are discussed.

  19. Serum Parathyroid Hormone Responses to Vitamin D Supplementation in Overweight/Obese Adults: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

    Directory of Open Access Journals (Sweden)

    Ashley Lotito

    2017-03-01

    Full Text Available Obesity is often associated with vitamin D deficiency and secondary hyperparathyroidism. Vitamin D supplementation typically leads to the reductions in serum parathyroid hormone (PTH levels, as shown in normal weight individuals. Meanwhile, the dose of vitamin D supplementation for the suppression of PTH may differ in overweight and obese adults. We conducted a systematic review and meta-analysis of randomized controlled trials to determine the dose of vitamin D supplementation required to suppress PTH levels in overweight/obese individuals. We identified 18 studies that examined overweight or obese healthy adults who were supplemented with varying doses of vitamin D3. The primary outcomes examined were changes in PTH and serum 25-hydroxyvitamin D (25OHD levels from baseline to post-treatment. The results of the meta-analysis showed that there was a significant treatment effect of vitamin D supplementation on PTH, total standardized mean difference (SMD (random effects = −0.38 (95% CI = −0.56 to −0.20, t = −4.08, p < 0.001. A significant treatment effect of vitamin D supplementation was also found on 25OHD, total SMD (random effects = 2.27 (95% CI = 1.48 to 3.06 t = 5.62, p < 0.001. Data from available clinical trials that supplemented adults with D3 ranging from 400 IU to 5714 IU, showed that 1000 IU of vitamin D supplementation best suppressed serum PTH levels, total SMD = −0.58, while vitamin D supplementation with 4000 IU showed the greatest increase in serum 25OH levels. Vitamin D and calcium supplementation of 700 IU and 500 mg, respectively, also showed a significant treatment effect on the suppression of PTH with a total SMD = −5.30 (95% CI = −9.72 to −0.88. In conclusion, the meta analysis of available clinical trials indicates that 1000 IU vitamin D supplementation can suppress serum PTH levels, while 4000 IU of vitamin D was associated with the largest increase in serum 25OHD levels in the overweight and obese

  20. Cetuximab in the treatment of head and neck cancer: preliminary results outside clinical trials

    Science.gov (United States)

    Dequanter, Didier; Shahla, Mohammad; Paulus, Pascal; Lothaire, Phillippe

    2010-01-01

    Introduction: The purpose of this study was to evaluate the clinical efficacy in our daily practice, outside clinical trials, of cetuximab plus radiotherapy in a majority of treatment-naive patients with locoregionally advanced head and neck squamous cell carcinomas. Methods: A retrospective study was performed to evaluate outcomes in patients who were treated definitively with cetuximab and radiotherapy (ExRT). Patients with stage III or IV, nonmetastatic, measurable squamous cell carcinoma of the head and neck (SCCHN) were eligible. Results: There were 18 males and two females. The median age was 61 years (range from 49 to 87 years old). Concurrent radiotherapy and cetuximab was used, in first line, in 17 patients with locally advanced disease; two patients with recurrent SCCHN, who were intolerant of Cisplatin-based regimens, were treated with radiotherapy combined with weekly cetuximab; and 1 patient received cetuximab and radiotherapy postoperatively. The median time of response was 10 months (range from 2 to 24 months). A partial response was observed in 11 cases; a complete response in nine cases. The occurrence of grade 2–3 skin toxicity was observed in 11 cases. Skin toxicity was clearly correlated with a better response and the duration of the response to the treatment. The use of cetuximab in combination with radiotherapy does not increase the side effects of radiotherapy. At the end of the follow-up, 17 patients died. Conclusion: Cetuximab, with its highly targeted mechanism of action and synergistic activity with current treatment modalities, is a valuable treatment option in head and neck patients. The effect of the epidermal growth factor receptor antagonist occurs without any change in the pattern and the severity of toxicity usually associated with head and neck radiation. Cetuximab seems not to provide the most benefit for patients with oropharyngeal cancers but will in patients with T4 tumors. However, the median duration of local control was

  1. [Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

    Science.gov (United States)

    Nakajima, Toshifusa

    2016-04-01

    Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media.

  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. EFFECTIVENESS OF GLYPHOSATE AND 2.4 D AMIN HERBICIDES TO CONTROL WEEDS UNDER Shorea selanica Bl. PLANTATION IN CARITA TRIAL GARDEN, BANTEN

    Directory of Open Access Journals (Sweden)

    Ari Wibowo

    2007-03-01

    Full Text Available A trial was carried out in Carita, West Java, to identify the effectiveness of Glyphosate and 2.4 D Amin Herbicide to control weeds under Shorea selanica Bl. plantation. The trial was conducted through the application of Glyphosate and 2.4 D Amin Herbicide with dosages of 5, 6, 7, 8 and 9 liter per ha and compared with Glyphosate herbicide 5 liter per ha, manual treatment, and control (no treatment. The result showed that Glyphosate and 2.4 D Amin Herbicide could be used to control weeds in order to maintaining S. selanica Bl. plantation. Minimum dosage of 6 liter/ha was effective to control weeds such as Chromolaena odorata DC, Mikania micrantha Will, Lantana camara L, Imperata cylindrica Beauv., Melastoma malabathricum L, and Boreria latifolia Bl. Furthermore, there was no symptom of poison on S. selanica Bl. plantation after herbicide application with all dosages applied.

  4. The ARCHER project (Advanced High-Temperature Reactors for Cogeneration of Heat and Electricity R&D)

    Energy Technology Data Exchange (ETDEWEB)

    Knol, S., E-mail: knol@nrg.eu [Nuclear Research and consultancy Group (NRG), PO Box 25, NL-1755 ZG Petten (Netherlands); Fütterer, M.A. [Joint Research Centre, Institute for Energy, Petten (Netherlands); Roelofs, F. [Nuclear Research and consultancy Group (NRG), PO Box 25, NL-1755 ZG Petten (Netherlands); Kohtz, N. [TÜV Rheinland, Köln (Germany); Laurie, M. [Joint Research Centre, Institute for Transuranium elements, Karlsruhe (Germany); Buckthorpe, D. [UMAN, University of Manchester, Manchester (United Kingdom); Scheuermann, W. [IKE, Stuttgart University, Stuttgart (Germany)

    2016-09-15

    The European HTR R&D project ARCHER (Advanced High-Temperature Reactors for Cogeneration of Heat and Electricity R&D) builds on a solid HTR technology foundation in Europe, established through former national UK and German HTR programs and in European framework programs. ARCHER runs from 2011 to 2015 and targets selected HTR R&D subjects that would specifically support demonstration, with a focus on experimental effort. In line with the R&D and deployment strategy of the European Sustainable Nuclear Energy Technology Platform (SNETP) ARCHER contributes to maintaining, strengthening and expanding the HTR knowledge base in Europe to lay the foundations for demonstration of nuclear cogeneration with HTR systems. The project consortium encompasses conventional and nuclear industry, utilities, Technical Support Organizations, R&D organizations and academia. ARCHER shares results with international partners in the Generation IV International Forum and collaborates directly with related projects in the US, China, Japan, the Republic of Korea and South Africa. The ARCHER project has finished, and the paper comprises an overview of the achievements of the project.

  5. Crizotinib for Advanced Non-Small Cell Lung Cancer

    Science.gov (United States)

    A summary of results from an international phase III clinical trial that compared crizotinib versus chemotherapy in previously treated patients with advanced lung cancer whose tumors have an EML4-ALK fusion gene.

  6. 75 FR 71463 - Dentek.Com, Inc. D/B/A Nsequence Center for Advanced Dentistry Reno, NV; Notice of Negative...

    Science.gov (United States)

    2010-11-23

    ... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-73,963] Dentek.Com, Inc. D/B/A Nsequence Center for Advanced Dentistry Reno, NV; Notice of Negative Determination on Reconsideration By... applicable to workers and former workers at Dentek.com , Inc., d/b/a nSequence Center for Advanced Dentistry...

  7. A blinded, randomized controlled trial of high-dose vitamin D supplementation to reduce recurrence of bacterial vaginosis.

    Science.gov (United States)

    Turner, Abigail Norris; Carr Reese, Patricia; Fields, Karen S; Anderson, Julie; Ervin, Melissa; Davis, John A; Fichorova, Raina N; Roberts, Mysheika Williams; Klebanoff, Mark A; Jackson, Rebecca D

    2014-11-01

    Low serum vitamin D levels have been associated with increased prevalence of the reproductive tract condition bacterial vaginosis (BV). The objective of this trial was to evaluate the effect of high-dose vitamin D supplementation on BV recurrence. This randomized, placebo-controlled, double-blinded trial enrolled 118 women with symptomatic BV from an urban sexually transmitted disease clinic (clinicaltrials.gov registration NCT01450462). All participants received 500 mg of oral metronidazole twice daily for 7 days. Intervention participants (n = 59) also received 9 doses of 50,000 IU of cholecalciferol (vitamin D3) over 24 weeks; control women (n = 59) received matching placebo. Recurrent BV was assessed via Nugent scoring after 4, 12, and 24 weeks. We assessed the effect of the intervention using an intention-to-treat approach, fitting Cox proportional hazards models to evaluate recurrent BV over the follow-up period. Most participants (74%) were black, with a median age of 26 years. Median presupplementation serum 25-hydroxyvitamin D [25(OH)D] was similar across randomization arms: 16.6 ng/mL in the vitamin D arm and 15.8 ng/mL in the control arm. At trial completion, median 25(OH)D among women receiving vitamin D was 30.5 ng/mL, vs 17.8 ng/mL in control women; 16% of women receiving vitamin D and 57% receiving placebo remained vitamin D deficient (<20 ng/mL). BV prevalence among women randomized to vitamin D was very similar to those randomized to placebo at the 4- and 12-week visits, but by the 24-week visit, BV prevalence was 65% among women in the vitamin D arm and 48% among control women. BV recurrence was not reduced by vitamin D supplementation (intention-to-treat hazard ratio, 1.11; 95% confidence interval, 0.68-1.81). Among women experiencing recurrent BV, median time to recurrence was 13.7 weeks in the vitamin D arm and 14.3 weeks in the control arm. Women receiving vitamin D experienced significant increases in serum 25(OH)D, but this increase was not

  8. SU-D-201-06: Remote Dosmetric Auditing of VMAT Deliveries for Clinical Trials Using EPID

    Energy Technology Data Exchange (ETDEWEB)

    Legge, K; Miri, N [University of Newcastle (Australia); Lehmann, J [Calvary Mater Newcastle (Australia); Vial, P [Liverpool Hospital (Australia); Greer, P [University of Newcastle (Australia); Calvary Mater Newcastle (Australia)

    2016-06-15

    Purpose: To develop a method for remote dosimetric auditing the delivery of VMAT using EPID which allows for simple, inexpensive and time efficient dosimetric credentialing for clinical trials. Methods: Remote centers are provided with CT datasets and planning guidelines to produce VMAT plans for a head and neck and a post-prostatectomy treatment. Plans are transferred in the planning system to two virtual water equivalent phantoms, one flat and one cylindrical. Cine images are acquired during VMAT delivery to the EPID in air with gantry angle recorded in image headers. Centers also deliver provided calibration plans to enable EPID signal to dose conversion, determination of the central axis, and correction of EPID sag prior to analysis. EPID images and planned doses are sent to the central site. EPID cine images are converted to dose in the virtual phantoms using an established backprojection method (King et al., Med.Phys. 2012) with EPID backscatter correction. Individual arcs (with gantry angles collapsed to zero) are evaluated at 10 cm depth in the flat phantom using 2D gamma, and total doses are evaluated in the cylindrical phantom using 3D gamma. Results are reported for criteria of 3%,3mm, 3%,2mm and 2%,2mm for all points greater than 10% of global maximum. Results: The pilot study for Varian centers has commenced, and three centers have been audited for head and neck plans and two for post-prostatectomy plans to date. The mean pass rate for arc-by-arc 2D analysis at 3%,3mm is 99.5% and for 3D analysis is 95.8%. A method for Elekta linacs using an inclinometer for gantry angle information is under development. Conclusion: Preliminary results for this new method are promising. The method takes advantage of EPID equipment available at most centers and clinically established software to provide a feasible, low cost solution to credentialing centers for clinical trials. Funding has been provided from Calvary Mater Newcastle Department of Radiation Oncology, TROG

  9. Advanced Sensors and Controls for Building Applications: Market Assessment and Potential R&D Pathways

    Energy Technology Data Exchange (ETDEWEB)

    Brambley, M. R. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Haves, P. [Lawrence Berkeley National Lab. (LBNL), Berkeley, CA (United States); McDonald, S. C. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Torcellini, P. [National Renewable Energy Lab. (NREL), Golden, CO (United States); Hansen, D. [U.S. Dept. of Energy, Washington, D.C. (United States); Holmberg, D. R. [National Institute of Science and Technology, Gaithersburg, MD (United States); Roth, K. W. [TIAX, LLC, Cambridge, MA (United States)

    2005-04-01

    This document provides a market assessment of existing building sensors and controls and presents a range of technology pathways (R&D options) for pursuing advanced sensors and building control strategies.

  10. A randomized controlled trial of Human Papillomavirus (HPV testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial

    Directory of Open Access Journals (Sweden)

    Smith Laurie W

    2010-03-01

    Full Text Available Abstract Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5% were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%. In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%. Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

  11. Results in the elderly with locally advanced rectal cancer from the ACCOR12/PRODIGE 2 phase III trial: Tolerance and efficacy

    International Nuclear Information System (INIS)

    François, Eric; Azria, David; Gourgou-Bourgade, Sophie; Jarlier, Marta; Martel-Laffay, Isabelle; Hennequin, Christophe; Etienne, Pierre-Luc; Vendrely, Véronique; Seitz, Jean-François; Conroy, Thierry; Juzyna, Beata; Gerard, Jean-Pierre

    2014-01-01

    Background: Rectal cancer predominantly affects the elderly. Unfortunately, this age category is under-represented in clinical trials because clinicians are loath to include patients with a high risk of comorbidity. Patients and methods: An exploratory analysis of the ACCORD12/PRODIGE 2 phase III trial was carried out to retrospectively compare the benefit of neoadjuvant chemotherapy between the elderly (⩾70 years; n = 142) and younger patients (<70 years; n = 442), this analysis was not preplanned in the study protocol. Patients with histologically confirmed resectable stage T3 or T4 rectal adenocarcinoma were eligible with an age limit of 80 years. Results: Overall, the two age categories did not statistically differ in terms of patient’s clinical and tumor baseline characteristics. Preoperative chemoradiotherapy leads to more severe grade 3/4 toxicities (25.6% vs. 15.8%, p = 0.01) and more permanent stomas (33.3% vs. 22.8%, p = 0.014) in elderly patients who were less often operated on than younger patients (95.8% vs. 99.0%, p = 0.008). The relative number of interventions per surgery type (p = 0.18), treatment efficacy in terms of R0 resection rate (88.6% vs. 90.6%; p = 0.54) and complete pathological response (14.7% vs. 16.9%; p = 0.55) were nearly identical between the two categories. Conclusion: Altogether these results warrant the development of specific optimal therapeutic strategies for the elderly

  12. Lung-MAP Launches: First Precision Medicine Trial From National Clinical Trials Network

    Science.gov (United States)

    A unique public-private collaboration today announced the initiation of the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with advanced squamous cell lung cancer. Squamous cell carcinom

  13. Looking into the Future: Toward Advanced 3D Biomaterials for Stem-Cell-Based Regenerative Medicine.

    Science.gov (United States)

    Liu, Zhongmin; Tang, Mingliang; Zhao, Jinping; Chai, Renjie; Kang, Jiuhong

    2018-04-01

    Stem-cell-based therapies have the potential to provide novel solutions for the treatment of a variety of diseases, but the main obstacles to such therapies lie in the uncontrolled differentiation and functional engraftment of implanted tissues. The physicochemical microenvironment controls the self-renewal and differentiation of stem cells, and the key step in mimicking the stem cell microenvironment is to construct a more physiologically relevant 3D culture system. Material-based 3D assemblies of stem cells facilitate the cellular interactions that promote morphogenesis and tissue organization in a similar manner to that which occurs during embryogenesis. Both natural and artificial materials can be used to create 3D scaffolds, and synthetic organic and inorganic porous materials are the two main kinds of artificial materials. Nanotechnology provides new opportunities to design novel advanced materials with special physicochemical properties for 3D stem cell culture and transplantation. Herein, the advances and advantages of 3D scaffold materials, especially with respect to stem-cell-based therapies, are first outlined. Second, the stem cell biology in 3D scaffold materials is reviewed. Third, the progress and basic principles of developing 3D scaffold materials for clinical applications in tissue engineering and regenerative medicine are reviewed. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  14. A randomized, double-blind, placebo-controlled trial of calcium acetate on serum phosphorus concentrations in patients with advanced non-dialysis-dependent chronic kidney disease

    Directory of Open Access Journals (Sweden)

    Ho Chiang-Hong

    2011-02-01

    Full Text Available Abstract Background Hyperphosphatemia in patients with chronic kidney disease (CKD contributes to secondary hyperparathyroidism, soft tissue calcification, and increased mortality risk. This trial was conducted to examine the efficacy and safety of calcium acetate in controlling serum phosphorus in pre-dialysis patients with CKD. Methods In this randomized, double-blind, placebo-controlled trial, 110 nondialyzed patients from 34 sites with estimated GFR 2 and serum phosphorus > 4.5 mg/dL were randomized to calcium acetate or placebo for 12 weeks. The dose of study drugs was titrated to achieve target serum phosphorus of 2.7-4.5 mg/dL. Serum phosphorus, calcium, iPTH, bicarbonate and serum albumin were measured at baseline and every 2 weeks for the 12 week study period. The primary efficacy endpoint was serum phosphorus at 12 weeks. Secondary endpoints were to measure serum calcium and intact parathyroid hormone (iPTH levels. Results At 12 weeks, serum phosphorus concentration was significantly lower in the calcium acetate group compared to the placebo group (4.4 ± 1.2 mg/dL vs. 5.1 ± 1.4 mg/dL; p = 0.04. The albumin-adjusted serum calcium concentration was significantly higher (9.5 ± 0.8 vs. 8.8 ± 0.8; p p Conclusions In CKD patients not yet on dialysis, calcium acetate was effective in reducing serum phosphorus and iPTH over a 12 week period. Trial Registration www.clinicaltrials.gov NCT00211978.

  15. 3D bioprinting for biomedical devices and tissue engineering: A review of recent trends and advances

    Directory of Open Access Journals (Sweden)

    Soroosh Derakhshanfar

    2018-06-01

    Full Text Available 3D printing, an additive manufacturing based technology for precise 3D construction, is currently widely employed to enhance applicability and function of cell laden scaffolds. Research on novel compatible biomaterials for bioprinting exhibiting fast crosslinking properties is an essential prerequisite toward advancing 3D printing applications in tissue engineering. Printability to improve fabrication process and cell encapsulation are two of the main factors to be considered in development of 3D bioprinting. Other important factors include but are not limited to printing fidelity, stability, crosslinking time, biocompatibility, cell encapsulation and proliferation, shear-thinning properties, and mechanical properties such as mechanical strength and elasticity. In this review, we recite recent promising advances in bioink development as well as bioprinting methods. Also, an effort has been made to include studies with diverse types of crosslinking methods such as photo, chemical and ultraviolet (UV. We also propose the challenges and future outlook of 3D bioprinting application in medical sciences and discuss the high performance bioinks.

  16. Ursodeoxycholic acid in advanced polycystic liver disease: A phase 2 multicenter randomized controlled trial.

    Science.gov (United States)

    D'Agnolo, Hedwig M A; Kievit, Wietske; Takkenberg, R Bart; Riaño, Ioana; Bujanda, Luis; Neijenhuis, Myrte K; Brunenberg, Ellen J L; Beuers, Ulrich; Banales, Jesus M; Drenth, Joost P H

    2016-09-01

    Ursodeoxycholic acid (UDCA) inhibits proliferation of polycystic human cholangiocytes in vitro and hepatic cystogenesis in a rat model of polycystic liver disease (PLD) in vivo. Our aim was to test whether UDCA may beneficially affect liver volume in patients with advanced PLD. We conducted an international, multicenter, randomized controlled trial in symptomatic PLD patients from three tertiary referral centers. Patients with PLD and total liver volume (TLV) ⩾2500ml were randomly assigned to UDCA treatment (15-20mg/kg/day) for 24weeks, or to no treatment. Primary endpoint was proportional change in TLV. Secondary endpoints were change in symptoms and health-related quality of life. We performed a post-hoc analysis of the effect of UDCA on liver cyst volume (LCV). We included 34 patients and were able to assess primary endpoint in 32 patients, 16 with autosomal dominant polycystic kidney disease (ADPKD) and 16 with autosomal dominant polycystic liver disease (ADPLD). Proportional TLV increased by 4.6±7.7% (mean TLV increased from 6697ml to 6954ml) after 24weeks of UDCA treatment compared to 3.1±3.8% (mean TLV increased from 5512ml to 5724ml) in the control group (p=0.493). LCV was not different after 24weeks between controls and UDCA treated patients (p=0.848). However, UDCA inhibited LCV growth in ADPKD patients compared to ADPKD controls (p=0.049). UDCA administration for 24weeks did not reduce TLV in advanced PLD, but UDCA reduced LCV growth in ADPKD patients. Future studies might explore whether ADPKD and ADPLD patients respond differently to UDCA treatment. Current therapies for polycystic liver disease are invasive and have high recurrence risks. Our trial showed that the drug, ursodeoxycholic acid, was not able to reduce liver volume in patients with polycystic liver disease. However, a subgroup analysis in patients that have kidney cysts as well showed that liver cyst volume growth was reduced in patients who received ursodeoxycholic acid in comparison

  17. Impact of Vitamin D on the Cardiovascular System in Advanced Chronic Kidney Disease (CKD) and Dialysis Patients.

    Science.gov (United States)

    Gluba-Brzózka, Anna; Franczyk, Beata; Ciałkowska-Rysz, Aleksandra; Olszewski, Robert; Rysz, Jacek

    2018-06-01

    In patients suffering from chronic kidney disease (CKD), the prevalence of cardiovascular disease is much more common than in the general population. The role of vitamin D deficiency had been underestimated until a significant association was found between vitamin D therapy and survival benefit in haemodialysis patients. Vitamin D deficiency is present even in the early stages of chronic kidney disease. The results of experimental studies have revealed the relationship between vitamin D deficiency and impairment of cardiac contractile function, higher cardiac mass and increased myocardial collagen content. Experimental models propose that intermediate end points for the relationship between vitamin D deficiency and higher risk of cardiovascular disease comprise diminished left ventricular hypertrophy (LVH), enhanced left ventricular diastolic function, and decreased frequency of heart failure. Multiple observational studies have demonstrated an association between the use of active vitamin D therapy in patients on dialysis and with CKD and improved survival. However, there are also many studies indicating important adverse effects of such treatment. Therefore, large randomized trials are required to analyze whether supplementation of vitamin D may affect outcomes and whether it is safe to be used in CKD patients.

  18. Advanced Exploration Systems Water Architecture Study Interim Results

    Science.gov (United States)

    Sargusingh, Miriam J.

    2013-01-01

    The mission of the Advanced Exploration System (AES) Water Recovery Project (WRP) is to develop advanced water recovery systems that enable NASA human exploration missions beyond low Earth orbit (LEO). The primary objective of the AES WRP is to develop water recovery technologies critical to near-term missions beyond LEO. The secondary objective is to continue to advance mid-readiness-level technologies to support future NASA missions. An effort is being undertaken to establish the architecture for the AES Water Recovery System (WRS) that meets both near- and long-term objectives. The resultant architecture will be used to guide future technical planning, establish a baseline development roadmap for technology infusion, and establish baseline assumptions for integrated ground and on-orbit Environmental Control and Life Support Systems definition. This study is being performed in three phases. Phase I established the scope of the study through definition of the mission requirements and constraints, as well as identifying all possible WRS configurations that meet the mission requirements. Phase II focused on the near-term space exploration objectives by establishing an International Space Station-derived reference schematic for long-duration (>180 day) in-space habitation. Phase III will focus on the long-term space exploration objectives, trading the viable WRS configurations identified in Phase I to identify the ideal exploration WRS. The results of Phases I and II are discussed in this paper.

  19. Chelation therapy after the Trial to Assess Chelation Therapy: results of a unique trial

    Science.gov (United States)

    Avila, Maria D.; Escolar, Esteban; Lamas, Gervasio A.

    2014-01-01

    Purpose of review EDTA chelation therapy has been in off-label use for the treatment of atherosclerosis. We review the results of the first large-scale randomized trial of this treatment. Recent findings The trial to assess chelation therapy was a $30 million National Institutes of Health-funded study of the safety and efficacy of EDTA-based chelation infusions in 1708 post-myocardial infarction (MI) patients. The trial to assess chelation therapy demonstrated a significant (P = 0.035) 18% reduction in a combined primary endpoint of death, MI, stroke, coronary revascularization, or hospitalization for angina. In diabetic patients the benefit was more extreme, with a 41% relative reduction in risk (P = 0.0002) and a 43% reduction in total mortality (P = 0.011). Safety data were favorable. A reduction of oxidative stress by chelation of toxic metals has been proposed as a possible mechanism of action. Summary Recent research suggests that EDTA chelation may be a well-tolerated and effective treatment for post-MI patients. Future replication and mechanistic studies are important prior to implementation in all post-MI patients. PMID:25023079

  20. EPIC Trial: education programme impact on serum phosphorous control in CKD 5D patients on hemodialysis

    Directory of Open Access Journals (Sweden)

    Carmen Tzanno Branco Martins

    Full Text Available Abstract Introduction: In stage 5D chronic kidney disease (CKD 5D patients, the encouragement of treatment adherence by health professionals is a significant clinical challenge. Objectives: This study evaluates the impact of a nutritional education programme on hyperphosphatemia, utilizing the transtheoretical model of behavior change (TMBC. Subjects and Methods: A prospective interventional study comprising 179 CKD 5D patients with hypophosphatemia. The 4-month educational programme took place during dialysis sessions. Demographic and laboratory data were evaluated, whilst the TMBC was utilized both pre- and post-intervention. Results: 132 patients showed a positive change and significant reduction in phosphate levels, whilst 47 patients showed a negative change and little reduction in phosphate levels. Positive changes were identified at different levels of literacy. 117/179 participants had ongoing treatment with sevelamer throughout the trial period. 61 patients with intact parathyroid hormone (iPTH 300 pg/ml also showed a decrease in phosphate levels. Conclusions: Nutritional education programmes can achieve excellent results when appropriately applied. An education programme may be effective across different literacy levels.

  1. Unilateral pallidotomy in Parkinson's disease : a randomised, single-blind, multicentre trial

    NARCIS (Netherlands)

    de Bie, RMA; de Haan, RJ; Nijssen, PCG; Rutgers, AWF; Beute, GN; Haaxma, R; Schmand, B; Staal, MJ; Speelman, J.D.

    1999-01-01

    Background The results of several cohort studies suggest that patients with advanced Parkinson's disease would benefit from unilateral pallidotomy. We have assessed the efficacy of unilateral pallidotomy in a randomised, single-blind, multicentre trial. Methods We enrolled 37 patients with advanced

  2. Advanced Transport Operating Systems Program

    Science.gov (United States)

    White, John J.

    1990-01-01

    NASA-Langley's Advanced Transport Operating Systems Program employs a heavily instrumented, B 737-100 as its Transport Systems Research Vehicle (TRSV). The TRSV has been used during the demonstration trials of the Time Reference Scanning Beam Microwave Landing System (TRSB MLS), the '4D flight-management' concept, ATC data links, and airborne windshear sensors. The credibility obtainable from successful flight test experiments is often a critical factor in the granting of substantial commitments for commercial implementation by the FAA and industry. In the case of the TRSB MLS, flight test demonstrations were decisive to its selection as the standard landing system by the ICAO.

  3. Comprehensive simulation-enhanced training curriculum for an advanced minimally invasive procedure: a randomized controlled trial.

    Science.gov (United States)

    Zevin, Boris; Dedy, Nicolas J; Bonrath, Esther M; Grantcharov, Teodor P

    2017-05-01

    There is no comprehensive simulation-enhanced training curriculum to address cognitive, psychomotor, and nontechnical skills for an advanced minimally invasive procedure. 1) To develop and provide evidence of validity for a comprehensive simulation-enhanced training (SET) curriculum for an advanced minimally invasive procedure; (2) to demonstrate transfer of acquired psychomotor skills from a simulation laboratory to live porcine model; and (3) to compare training outcomes of SET curriculum group and chief resident group. University. This prospective single-blinded, randomized, controlled trial allocated 20 intermediate-level surgery residents to receive either conventional training (control) or SET curriculum training (intervention). The SET curriculum consisted of cognitive, psychomotor, and nontechnical training modules. Psychomotor skills in a live anesthetized porcine model in the OR was the primary outcome. Knowledge of advanced minimally invasive and bariatric surgery and nontechnical skills in a simulated OR crisis scenario were the secondary outcomes. Residents in the SET curriculum group went on to perform a laparoscopic jejunojejunostomy in the OR. Cognitive, psychomotor, and nontechnical skills of SET curriculum group were also compared to a group of 12 chief surgery residents. SET curriculum group demonstrated superior psychomotor skills in a live porcine model (56 [47-62] versus 44 [38-53], Ppsychomotor skills in the live porcine model and in the OR in a human patient (56 [47-62] versus 63 [61-68]; P = .21). SET curriculum group demonstrated inferior knowledge (13 [11-15] versus 16 [14-16]; P<.05), equivalent psychomotor skill (63 [61-68] versus 68 [62-74]; P = .50), and superior nontechnical skills (41 [38-45] versus 34 [27-35], P<.01) compared with chief resident group. Completion of the SET curriculum resulted in superior training outcomes, compared with conventional surgery training. Implementation of the SET curriculum can standardize training

  4. Report of evaluation on socio-economic effects of R and D results in Japan Atomic Energy Research Institute (JAERI)

    International Nuclear Information System (INIS)

    2002-08-01

    Japan Atomic Energy Research Institute (JAERI), as a core organization devoted to comprehensive nuclear energy research, has steadily promoted nuclear energy research aiming at long-term and stable supply of energy supporting the basis of national existence, advanced nuclear science and engineering leading to increase in Japanese industrial competitive power, etc. Through these undertaking, JAERI has produced a lot of remarkable achievements to contribute the national requests mentioned above. In total, about 1.8 trillion-yen of national funds and over 60,000 person · years of researchers and technical staffs have been invested in the R and D's for the past 45 years. Recently it has been argued and recognized to evaluate how the profits of R and D results in public research institutes supported by national funds are returned to the Japanese people as taxpayers and society as part of an administrative and financial reform. Then, seeing its 45th anniversary, JAERI has tried to evaluate the effects of the R and D achievements on the Japanese society and economy apart from the reviews on the management of the organization and research results by the ex-house experts from the viewpoints of specialty and technical aspects. In order to execute the aforementioned evaluation, JAERI established the in-house Ad hoc Committee for Evaluation of R and D Achievements where decision of the evaluation plan is made, in July 2001, and executed the evaluation followed by assembling the necessary database collected from individual branches. Results obtained from these activities were finally summarized in the Ad hoc Committee. Because a methodology for quantitative evaluation of the economical effects, i.e. cost-benefit effects of R and D's was not established yet, the evaluation was prudently carried out with the assistance of three think tanks and under advices by three ex-house experts. R and D's in JAERI are not limited to the ones where benefits corresponding to profits can be

  5. Needs of Advanced Safeguards Technologies for Future Nuclear Fuel Cycle (FNFC) Facilities and a Trial Application of SBD Concept to Facility Design of a Hypothetical FNFC Facility

    International Nuclear Information System (INIS)

    Seya, M.; Hajima, R.; Nishimori, N.; Hayakawa, T.; Kikuzawa, N.; Shizuma, T.; Fujiwara, M.

    2010-01-01

    Some of future nuclear fuel cycle (FNFC) facilities are supposed to have the characteristic features of very large throughput of plutonium, low decontamination reprocessing (no purification process; existence of certain amount of fission products (FP) in all process material), full minor actinides (MA) recycle, and treatment of MOX with FP and MA in fuel fabrication. In addition, the following international safeguards requirements have to be taken into account for safeguards approaches of the FNFC facilities. -Application of integrated safeguards (IS) approach; -Remote (unattended) verification; - 'Safeguards by Design' (SBD) concept. These features and requirements compel us to develop advanced technologies, which are not emerged yet. In order to realize the SBD, facility designers have to know important parts of design information on advanced safeguards systems before starting the facility design. The SBD concept requires not only early start of R and D of advanced safeguards technologies (before starting preliminary design of the facility) but also interaction steps between researchers working on safeguards systems and nuclear facility designers. The interaction steps are follows. Step-1; researchers show images of advanced safeguards systems to facility designers based on their research. Step-2; facility designers take important design information on safeguards systems into process systems of demonstration (or test) facility. Step-3; demonstration and improvement of both systems based on the conceptual design. Step-4; Construction of a FNFC facility with the advanced safeguards systems We present a trial application of the SBD concept to a hypothetical FNFC facility with an advanced hybrid K-edge densitometer and a Pu NDA system for spent nuclear fuel assembly using laser Compton scattering (LCS) X-rays and γ-rays and other advanced safeguards systems. (author)

  6. Effect of Vitamin D Supplementation on the Level of Circulating High-Sensitivity C-Reactive Protein: A Meta-Analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Neng Chen

    2014-06-01

    Full Text Available Vitamin D might elicit protective effects against cardiovascular disease by decreasing the level of circulating high-sensitivity C-reactive protein (hs-CRP, an inflammatory marker. Thus, we conducted a meta-analysis of randomized controlled trials to evaluate the association of vitamin D supplementation with circulating hs-CRP level. A systematic literature search was conducted in September 2013 (updated in February 2014 via PubMed, Web of Science, and Cochrane library to identify eligible studies. Either a fixed-effects or a random-effects model was used to calculate pooled effects. The results of the meta-analysis of 10 trials involving a total of 924 participants showed that vitamin D supplementation significantly decreased the circulating hs-CRP level by 1.08 mg/L (95% CI, −2.13, −0.03, with the evidence of heterogeneity. Subgroup analysis suggested a higher reduction of 2.21 mg/L (95% CI, −3.50, −0.92 among participants with baseline hs-CRP level ≥5 mg/L. Meta-regression analysis further revealed that baseline hs-CRP level, supplemental dose of vitamin D and intervention duration together may be attributed to the heterogeneity across studies. In summary, vitamin D supplementation is beneficial for the reduction of circulating hs-CRP. However, the result should be interpreted with caution because of the evidence of heterogeneity.

  7. Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

    Science.gov (United States)

    Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

    2008-12-01

    Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

  8. Adjuvant radiotherapy for pathologically advanced prostate cancer a randomized clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Ian, M.; Thompson, J.R.; Catherine, M.; Tangen, P.H.; Paradelo, J.; Scott Lucia, M.; Miller, G.; Troyer, D.; Messing, E.; Forman, J.; Chin, J.; Swanson, G.; Canby-Hagino, E.; Crawford, E.D

    2008-01-15

    Context - Despite a stage-shift to earlier cancer stages and lower tumor volumes for prostate cancer, pathologically advanced disease is detected at radical prostatectomy in 38% to 52% of patients. However, the optimal management of these patients after radical prostatectomy is unknown. Objective - To determine whether adjuvant radiotherapy improves metastasis-free survival in patients with stage pT3 NO MO prostate cancer. Design, Setting, and Patients - Randomized, prospective, multi-institutional, US clinical trial with enrollment between August 15, 1988, and January 1, 1997 (with database frozen for statistical analysis on September 21, 2005). Patients were 425 men with pathologically advanced prostate cancer who had undergone radical prostatectomy. Intervention - Men were randomly assigned to receive 60 to 64 Gy of external beam radiotherapy delivered to the prostatic fossa (n = 214) or usual care plus observation (n = 211). Main Outcome Measures - Primary outcome was metastasis-free survival, defined as time to first occurrence of metastatic disease or death due to any cause. Secondary outcomes included prostate-specific antigen (PSA) relapse, recurrence-free survival, overall survival, freedom from hormonal therapy, and postoperative complications. Results - Among the 425 men, median follow-up was 10.6 years (inter-quartile range, 9.2-12.7 years). For metastasis-free survival,76 (35.5%) of 214 men in the adjuvant radiotherapy group were diagnosed with metastatic disease or died (median metastasis-free estimate, 14.7 years), compared with 91 (43.1%) of 211 (median metastasis-free estimate, 13.2 years) of those in the observation group (hazard ratio [HR], 0.75; 95% CI, 0.55-1.02; P = .06). There were no significant between-group differences for overall survival (71 deaths, median survival of 14.7 years for radiotherapy vs 83 deaths, median survival of 13.8 years for observation; HR, 0.80; 95% Cl, 0.58-1.09; P =.16). PSA relapse (median PSA relapse-free survival

  9. Adjuvant radiotherapy for pathologically advanced prostate cancer a randomized clinical trial

    International Nuclear Information System (INIS)

    Ian, M.; Thompson, J.R.; Catherine, M.; Tangen, P.H.; Paradelo, J.; Scott Lucia, M.; Miller, G.; Troyer, D.; Messing, E.; Forman, J.; Chin, J.; Swanson, G.; Canby-Hagino, E.; Crawford, E.D.

    2008-01-01

    Context - Despite a stage-shift to earlier cancer stages and lower tumor volumes for prostate cancer, pathologically advanced disease is detected at radical prostatectomy in 38% to 52% of patients. However, the optimal management of these patients after radical prostatectomy is unknown. Objective - To determine whether adjuvant radiotherapy improves metastasis-free survival in patients with stage pT3 NO MO prostate cancer. Design, Setting, and Patients - Randomized, prospective, multi-institutional, US clinical trial with enrollment between August 15, 1988, and January 1, 1997 (with database frozen for statistical analysis on September 21, 2005). Patients were 425 men with pathologically advanced prostate cancer who had undergone radical prostatectomy. Intervention - Men were randomly assigned to receive 60 to 64 Gy of external beam radiotherapy delivered to the prostatic fossa (n = 214) or usual care plus observation (n = 211). Main Outcome Measures - Primary outcome was metastasis-free survival, defined as time to first occurrence of metastatic disease or death due to any cause. Secondary outcomes included prostate-specific antigen (PSA) relapse, recurrence-free survival, overall survival, freedom from hormonal therapy, and postoperative complications. Results - Among the 425 men, median follow-up was 10.6 years (inter-quartile range, 9.2-12.7 years). For metastasis-free survival,76 (35.5%) of 214 men in the adjuvant radiotherapy group were diagnosed with metastatic disease or died (median metastasis-free estimate, 14.7 years), compared with 91 (43.1%) of 211 (median metastasis-free estimate, 13.2 years) of those in the observation group (hazard ratio [HR], 0.75; 95% CI, 0.55-1.02; P = .06). There were no significant between-group differences for overall survival (71 deaths, median survival of 14.7 years for radiotherapy vs 83 deaths, median survival of 13.8 years for observation; HR, 0.80; 95% Cl, 0.58-1.09; P =.16). PSA relapse (median PSA relapse-free survival

  10. BA DEMO R and D, activities on advanced tritium breeders in EU

    Energy Technology Data Exchange (ETDEWEB)

    Knitter, Regina; Kolb, Matthias H.H.; Leys, Oliver H.J.B. [Karlsruhe Institute of Technology (KIT), Eggenstein-Leopoldshafen (Germany). Inst. for Applied Materials (IAM-WPT)

    2013-07-01

    Within the Broader Approach (BA) activities on DEMO R and D, EU and Japan have launched a collaborative project on scalable and reliable production routes for advanced tritium breeders. Besides the development of the fabrication process, the reprocessing as well as the long-term stability of advanced breeder is to be investigated. In the EU, a modified melt-based process for the fabrication of lithium orthosilicate pebbles have been developed. Besides the optimization of process parameters, the chemical composition of the pebbles was altered by additions of titania in order to increase the mechanical properties by the formation of lithium metatitanate as a secondary, strengthening phase. (orig.)

  11. 1D and 2D graphdiynes. Recent advances on the synthesis at interfaces and potential nanotechnological applications

    Energy Technology Data Exchange (ETDEWEB)

    Chen, Zhi; Molina-Jiron, Concepcion; Klyatskaya, Svetlana [Institute of Nanotechnology (INT), Karlsruhe Institute of Technology (KIT), Eggenstein-Leopoldshafen (Germany); Klappenberger, Florian [Physik Department E20, Technische Universitaet Muenchen, Garching (Germany); Ruben, Mario [Institute of Nanotechnology (INT), Karlsruhe Institute of Technology (KIT), Eggenstein-Leopoldshafen (Germany); IPCMS-CNRS, Universite de Strasbourg (France)

    2017-11-15

    In solution-based chemistry butadiyne linkage through the homocoupling reaction of alkynes is a versatile tool for the synthesis of π-conjugated polymers, scaffolds and networks. To date this strategy was actively implemented towards chemical synthesis at interfaces. In this review paper we summarize recent advances in the syntheses of 1D wires, 2D single-layers and thin films of graphdiyne-related carbon materials at interfaces and their potential applications in nanotechnology. With a high degree of π-conjunction, uniformly distributed pores and tunable electronic properties such 2D all-carbon networks with butadiyne linkages also known as 'graphdiynes' have been successfully employed in the field-effected emission devices, solar cells, for Li ion storage and oil water separation, and as catalysis or chemical sensors. (copyright 2017 by WILEY-VCH Verlag GmbH and Co. KGaA, Weinheim)

  12. Longevity of daily oral vitamin D3 supplementation: differences in 25OHD and 24,25(OH)2D observed 2 years after cessation of a 1-year randomised controlled trial (VICtORy RECALL).

    Science.gov (United States)

    Macdonald, H M; Gryka, A; Tang, J C Y; Aucott, L S; Fraser, W D; Wood, A D

    2017-12-01

    To determine how long vitamin D lasts after supplementation ceases, the marker of status was measured 2 and 3 years after a 1-year trial. Compared to placebo, the proportion of vitamin D-deficient women was still lower, if they had taken daily vitamin D3, after 2 years, indicating its longevity. The purpose of this study was to determine longevity of vitamin D status following cessation of vitamin D3 supplementation, 2 and 3 years after a 1-year randomised, double-blind placebo controlled trial and to investigate possible predictive factors. Caucasian non-smoking postmenopausal women randomised to ViCtORY (2009-2010), who had not taken vitamin D supplements since the trial ended, were invited to attend follow-up visits. Total 25-hydroxyvitamin D (25OHD) and 24,25-dihydroxyvitamin D (24,25OH2D) were measured by dual tandem mass spectrometry of serum samples following removal of protein and de-lipidation; the original randomised controlled trial (RCT) samples were re-analysed simultaneously. Vitamin D-binding protein (VDBP) was measured by monoclonal immunoassay. In March 2012 and March 2013, 159 women (mean (SD) age 67.6 (2.1) years) re-attended, equally distributed between the original treatment groups: daily vitamin D3 (400 IU, 1000 IU) and placebo. One month after the RCT ended (March 2010), the proportion of women in placebo, 400 IU and 1000 IU vitamin D3 groups, respectively, with 25OHD  25 nmol/L.

  13. Results of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial by stroke subtypes

    DEFF Research Database (Denmark)

    Amarenco, Pierre; Benavente, Oscar; Goldstein, Larry B

    2009-01-01

    BACKGROUND AND PURPOSE: The SPARCL trial showed that atorvastatin 80 mg/d reduces the risk of stroke and other cardiovascular events in patients with recent stroke or transient ischemic attack (TIA). We tested the hypothesis that the benefit of treatment varies according to index event stroke...... subtype. METHODS: Subjects with stroke or TIA without known coronary heart disease were randomized to atorvastatin 80 mg/d or placebo. The SPARCL primary end point was fatal or nonfatal stroke. Secondary end points included major cardiovascular events (MCVE; stroke plus major coronary events). Cox...... regression models testing for an interaction with treatment assignment were used to explore potential differences in efficacy based on stroke subtype. RESULTS: For subjects randomized to atorvastatin versus placebo, a primary end point occurred in 13.1% versus 18.6% of those classified as having large vessel...

  14. Management of Locally Advanced Cancer Cervix an Indian Perspective.

    Science.gov (United States)

    Singh, J K; Chauhan, Richa

    2015-01-01

    Cervical cancer has a major impact on the lives of Indian women with an estimated 122, 844 new cases of cervical cancer in the year 2012. About 80% of these cases present in a locally advanced stage leading to high morbidity and mortality. Because of lack of public awareness and infrastructure for screening and early detection in developing countries, this late presentation is likely to continue in the coming years. Radiation therapy has been the treatment of choice for patients with locally advanced cancer cervix. Many clinical trials and meta-analyses have shown a significant improvement in overall and progression-free survival with decreased local and distant recurrences with the use of concurrent chemotherapy with radiation. Most of these trials have been done in women from developed countries where the patient and disease profile are entirely different from ours. Recently, few trials from India have also shown promising results in locally advanced cancer cervix with concurrent chemoradiotherapy but toxicities remain a major concern. Further exploration is required for the use of concurrent chemo radiation prior to incorporating it into routine clinical practice.

  15. 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.

  16. Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models

    Directory of Open Access Journals (Sweden)

    Singla NK

    2014-12-01

    Full Text Available Neil K Singla,1 Jacques E Chelly,2 David R Lionberger,3 Joseph Gimbel,4 Luis Sanin,5 Jonathan Sporn,5 Ruoyong Yang,5 Raymond Cheung,5 Lloyd Knapp,6 Bruce Parsons5 1Lotus Clinical Research, Pasadena, CA, USA; 2Division of Acute Interventional Perioperative Pain, Department of Anesthesiology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; 3Department of Orthopedic Surgery, Baylor College of Medicine, Houston, TX, USA; 4Arizona Research Center, Phoenix, AZ, USA; 5Pfizer Inc., New York, NY, USA; 6Pfizer Inc., New London, CT, USA Purpose: To evaluate the efficacy and safety of pregabalin (150 or 300 mg/d as an adjunctive therapy for the treatment of postoperative pain. Patients and methods: This study reports findings from three separate, multicenter, randomized, double-blind, placebo-controlled trials of adjunctive pregabalin for the treatment of postoperative pain. Patients underwent one of three categories of surgical procedures (one procedure per study: elective inguinal hernia repair (post-IHR; elective total knee arthroplasty (post-TKA; or total abdominal hysterectomy (posthysterectomy. The primary endpoint in each trial, mean worst pain over the past 24 hours, was assessed 24 hours post-IHR and posthysterectomy, and 48 hours post-TKA. Patients rated their pain on a scale from 0 to 10, with higher scores indicating greater pain severity. Results: In total, 425 (post-IHR, 307 (post-TKA, and 501 (posthysterectomy patients were randomized to treatment. There were no statistically significant differences between the pregabalin and placebo groups with respect to the primary endpoint in any of the three trials. The least squares mean difference in worst pain, between 300 mg/d pregabalin and placebo, was -0.7 (95% confidence interval [CI] =-1.4, -0.1; Hochberg adjusted P=0.067 post-IHR; -0.34 (95% CI =-1.07, 0.39; P=0.362 post-TKA; and -0.2 (95% CI =-0.66, 0.31; P=0.471 posthysterectomy. Conclusion: There were no significant differences

  17. Improving the care of children with advanced cancer by using an electronic patient-reported feedback intervention: results from the PediQUEST randomized controlled trial.

    Science.gov (United States)

    Wolfe, Joanne; Orellana, Liliana; Cook, E Francis; Ullrich, Christina; Kang, Tammy; Geyer, Jeffrey Russell; Feudtner, Chris; Weeks, Jane C; Dussel, Veronica

    2014-04-10

    This study aimed to determine whether feeding back patient-reported outcomes (PROs) to providers and families of children with advanced cancer improves symptom distress and health-related quality of life (HRQoL). This study was a parallel, multicentered pilot randomized controlled trial. At most once per week, children age ≥ 2 years old with advanced cancer or their parent completed the computer-based Pediatric Quality of Life and Evaluation of Symptoms Technology (PediQUEST) survey consisting of age- and respondent-adapted versions of the Memorial Symptom Assessment Scale (MSAS), Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL4.0), and an overall Sickness question. In the intervention group (n = 51), oncologists and families received printed reports summarizing PROs; e-mails were sent to oncologists and subspecialists when predetermined scores were exceeded. No feedback was provided in the control group (n = 53). Primary outcomes included linear trends of MSAS, PedsQL4.0 total and subscale scores, and Sickness scores during 20 weeks of follow-up, along with child, parent, and provider satisfaction with PediQUEST feedback. Feedback did not significantly affect average MSAS, PedsQL4.0, or Sickness score trends. Post hoc subgroup analyses among children age ≥ 8 years who survived 20 weeks showed that feedback improved PedsQL4.0 emotional (+8.1; 95% CI, 1.8 to 14.4) and Sickness (-8.2; 95% CI, -14.2 to -2.2) scores. PediQUEST reports were valued by children, parents, and providers and contributed at least sometimes to physician initiation of a psychosocial consult (56%). Although routine feedback of PROs did not significantly affect the child's symptoms or HRQoL, changes were in expected directions and improvements observed in emotional HRQoL through exploratory analyses were encouraging. Importantly, children, parents, and providers value PRO feedback.

  18. A pilot randomized controlled trial of D-cycloserine and distributed practice as adjuvants to constraint-induced movement therapy after stroke.

    Science.gov (United States)

    Nadeau, Stephen E; Davis, Sandra E; Wu, Samuel S; Dai, Yunfeng; Richards, Lorie G

    2014-01-01

    Background. Phase III trials of rehabilitation of paresis after stroke have proven the effectiveness of intensive and extended task practice, but they have also shown that many patients do not qualify, because of severity of impairment, and that many of those who are treated are left with clinically significant deficits. Objective. To test the value of 2 potential adjuvants to normal learning processes engaged in constraint-induced movement therapy (CIMT): greater distribution of treatment over time and the coadministration of d-cycloserine, a competitive agonist at the glycine site of the N-methyl-D-aspartate glutamate receptor. Methods. A prospective randomized single-blind parallel-group trial of more versus less condensed therapy (2 vs 10 weeks) and d-cycloserine (50 mg) each treatment day versus placebo (in a 2 × 2 design), as potential adjuvants to 60 hours of CIMT. Results. Twenty-four participants entered the study, and 22 completed it and were assessed at the completion of treatment and 3 months later. Neither greater distribution of treatment nor treatment with d-cycloserine significantly augmented retention of gains achieved with CIMT. Conclusions. Greater distribution of practice and treatment with d-cycloserine do not appear to augment retention of gains achieved with CIMT. However, concentration of CIMT over 2 weeks ("massed practice") appears to confer no advantage either. © The Author(s) 2014.

  19. Phase 2 Clinical Trials: D-Methionine to Reduce Noise-Induced Hearing Loss

    Science.gov (United States)

    2016-07-01

    Pharmaceuticals: Task completed. KP Pharmaceutical Technology, Indianapolis , Indiana is the drug manufacturer for this clinical trial. e. FDA/Regulatory...and Open House at Fort Jackson. j. June 8-9: Dr. Campbell interviewed with the Wall Street Journal at Fort Jackson. k. June 10-11, 2015: Dr...recommended by DoD Operational Medicine, Dr. Campbell, in conjunction with her business partner Jennifer Seibert, started a new biotech company, MetArmor

  20. A randomized controlled trial of vitamin D dosing strategies after acute hip fracture: No advantage of loading doses over daily supplementation

    Directory of Open Access Journals (Sweden)

    Farrauto Leonardo

    2011-06-01

    Full Text Available Abstract Background There remains uncertainty regarding the appropriate therapeutic management of hip fracture patients. The primary aim of our study was to examine whether large loading doses in addition to daily vitamin D offered any advantage over a simple daily low-dose vitamin D regimen for increasing vitamin D levels. Methods In this randomized controlled study, patients over age 50 with an acute fragility hip fracture were enrolled from two hospital sites in Ontario, Canada. Participants were randomized to one of three loading dose groups: placebo; 50,000 IU vitamin D2; or 100,000 IU D2. Following a placebo/loading dose, all patients received a daily tablet of 1,000 IU vitamin D3 for 90 days. Serum 25-hydroxy vitamin D (25-OHD was measured at baseline, discharge from acute care (approximately 4-weeks, and 3-months. Results Sixty-five patients were enrolled in the study (44% male. An immediate rise in 25-OHD occurred in the 100,000 group, however there were no significant differences in 25-OHD between the placebo, 50,000 and 100,000 loading dose groups after 4-weeks (69.3, 84.5, 75.6 nmol/L, p = 0.15 and 3-months (86.7, 84.2, 73.3 nmol/L, p = 0.09, respectively. At the end of the study, approximately 75% of the placebo and 50,000 groups had reached the target therapeutic range (75 nmol/L, and 44% of the 100,000 group. Conclusions In correcting vitamin D insufficiency/deficiency in elderly patients with hip fracture, our findings suggest that starting with a lower daily dose of Vitamin D3 achieved similar results as providing an additional large loading dose of Vitamin D2. At the end of the study, all three groups were equally effective in attaining improvement in 25-OHD levels. Given that a daily dose of 1,000 IU vitamin D3 (with or without a loading dose resulted in at least 25% of patients having suboptimal vitamin D status, patients with acute hip fracture may benefit from a higher daily dose of vitamin D. Trial registration Clinical

  1. Limited accessibility to designs and results of Japanese large-scale clinical trials for cardiovascular diseases

    Directory of Open Access Journals (Sweden)

    Tsutani Kiichiro

    2011-04-01

    Full Text Available Abstract Background Clinical evidence is important for improving the treatment of patients by health care providers. In the study of cardiovascular diseases, large-scale clinical trials involving thousands of participants are required to evaluate the risks of cardiac events and/or death. The problems encountered in conducting the Japanese Acute Myocardial Infarction Prospective (JAMP study highlighted the difficulties involved in obtaining the financial and infrastructural resources necessary for conducting large-scale clinical trials. The objectives of the current study were: 1 to clarify the current funding and infrastructural environment surrounding large-scale clinical trials in cardiovascular and metabolic diseases in Japan, and 2 to find ways to improve the environment surrounding clinical trials in Japan more generally. Methods We examined clinical trials examining cardiovascular diseases that evaluated true endpoints and involved 300 or more participants using Pub-Med, Ichushi (by the Japan Medical Abstracts Society, a non-profit organization, websites of related medical societies, the University Hospital Medical Information Network (UMIN Clinical Trials Registry, and clinicaltrials.gov at three points in time: 30 November, 2004, 25 February, 2007 and 25 July, 2009. Results We found a total of 152 trials that met our criteria for 'large-scale clinical trials' examining cardiovascular diseases in Japan. Of these, 72.4% were randomized controlled trials (RCTs. Of 152 trials, 9.2% of the trials examined more than 10,000 participants, and 42.8% examined between 1,000 and 10,000 participants. The number of large-scale clinical trials markedly increased from 2001 to 2004, but suddenly decreased in 2007, then began to increase again. Ischemic heart disease (39.5% was the most common target disease. Most of the larger-scale trials were funded by private organizations such as pharmaceutical companies. The designs and results of 13 trials were not

  2. An advanced strategy for wind speed forecasting using expert 2-D FIR filters

    Directory of Open Access Journals (Sweden)

    MOGHADDAM, A. A.

    2010-11-01

    Full Text Available Renewable energies such as wind and solar have become the most attractive means of electricity generation nowadays. Social and environmental benefits as well as economical issues result in further utilization of such these energy resources. In this regard, wind energy plays an important roll in operation of small-scale power systems like Micro Grid. On the other hand, wind stochastic nature in different time and place horizons, makes accurate forecasting of its behavior an inevitable task for market planners and energy management systems. In this paper an advanced strategy for wind speed estimation has been purposed and its superior performance is compared to that of conventional methods. The model is based on linear predictive filtering and image processing principles using 2-D FIR filters. To show the efficiency of purposed predictive model different FIR filters are designed and tested through similar data. Wind speed data have been collected during the period January 1, 2009 to December 31, 2009 from Casella automatic weather station at Plymouth. It is observed that 2-D FIR filters act more accurately in comparison with 1-D conventional representations; however, their prediction ability varies considerably through different filter sizing.

  3. C-reactive protein and fibrinogen of bedridden older patients in a six-month vitamin D supplementation trial.

    Science.gov (United States)

    Bjorkman, M P; Sorva, A J; Tilvis, R S

    2009-05-01

    To elucidate the association between vitamin D status, C-reactive protein (CRP) and fibrinogen. Secondary analysis of a randomised double-blind placebo controlled trial. Four longterm care hospitals (1215 beds) in Helsinki, Finland. 218 long-term inpatients aged over 65 years. Eligible patients (n = 218) were randomized to receive 0 IU/d, 400 IU/d, or 1200 IU/d cholecalciferol for six months. Plasma 25-hydroxyvitamin D (25-OHD), parathyroid hormone (PTH), high sensitive CRP, fibrinogen, amino-terminal propeptide of type I procollagen (PINP), and carboxy-terminal telopeptide of type I collagen (ICTP) were measured. The patients were aged (84.5 +/- 7.5 years), vitamin D deficient (25-OHD = 23 +/- 10 nmol/l), chronically bedridden and in stable general condition. The mean baseline CRP and fibrinogen were 10.86 mg/l (0.12 mg/l - 125.00 mg/l) and 4,7 g/l (2.3 g/l - 8.6 g/l), respectively. CRP correlated with ICTP (r = 0.217, p = 0.001), but not with vitamin D status. Supplementation significantly increased 25-OHD concentrations, but the changes in CRP and fibrinogen were insignificant and inconsistent. The post-trial CRP concentrations (0.23 mg/l -138.00 mg/l) correlated with ICTP (r = 0.156, p bedridden older patients.

  4. The role of 25-hydroxyvitamin D deficiency in promoting insulin resistance and inflammation in patients with Chronic Kidney Disease: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Johnson David W

    2009-12-01

    Full Text Available Abstract Background Approximately 50% of patients with stage 3 Chronic Kidney Disease are 25-hydroxyvitamin D insufficient, and this prevalence increases with falling glomerular filtration rate. Vitamin D is now recognised as having pleiotropic roles beyond bone and mineral homeostasis, with the vitamin D receptor and metabolising machinery identified in multiple tissues. Worryingly, recent observational data has highlighted an association between hypovitaminosis D and increased cardiovascular mortality, possibly mediated via vitamin D effects on insulin resistance and inflammation. The main hypothesis of this study is that oral Vitamin D supplementation will ameliorate insulin resistance in patients with Chronic Kidney Disease stage 3 when compared to placebo. Secondary hypotheses will test whether this is associated with decreased inflammation and bone/adipocyte-endocrine dysregulation. Methods/Design This study is a single-centre, double-blinded, randomised, placebo-controlled trial. Inclusion criteria include; estimated glomerular filtration rate 30-59 ml/min/1.73 m2; aged ≥18 on entry to study; and serum 25-hydroxyvitamin D levels Discussion To date, no randomised controlled trial has been performed in pre-dialysis CKD patients to study the correlation between vitamin D status with supplementation, insulin resistance and markers of adverse cardiovascular risk. We remain hopeful that cholecalciferol may be a safe intervention, with health benefits beyond those related to bone-mineral homeostasis. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12609000246280.

  5. A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D.

    Science.gov (United States)

    Eswaran, Shanti L; Chey, William D; Han-Markey, Theresa; Ball, Sarah; Jackson, Kenya

    2016-12-01

    There has been an increasing interest in the role of fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) in irritable bowel syndrome (IBS). We report results from the first randomized controlled trial of the low FODMAP diet in US adults with IBS and diarrhea (IBS-D). The objectives were to compare the efficacy of the low FODMAP diet vs. a diet based upon modified National Institute for Health and Care Excellence guidelines (mNICE) on overall and individual symptoms in IBS-D patients. This was a single-center, randomized-controlled trial of adult patients with IBS-D (Rome III) which compared 2 diet interventions. After a 2-week screening period, eligible patients were randomized to a low FODMAP or mNICE diet for 4 weeks. The primary end point was the proportion of patients reporting adequate relief of IBS-D symptoms ≥50% of intervention weeks 3-4. Secondary outcomes included a composite end point which required response in both abdominal pain (≥30% reduction in mean daily pain score compared with baseline) and stool consistency (decrease in mean daily Bristol Stool Form of ≥1 compared with baseline), abdominal pain and stool consistency responders, and other key individual IBS symptoms assessed using daily questionnaires. After screening, 92 subjects (65 women, median age 42.6 years) were randomized. Eighty-four patients completed the study (45 low FODMAP, 39 mNICE). Baseline demographics, symptom severity, and nutrient intake were similar between groups. Fifty-two percent of the low FODMAP vs. 41% of the mNICE group reported adequate relief of their IBS-D symptoms (P=0.31). Though there was no significant difference in the proportion of composite end point responders (P=0.13), the low FODMAP diet resulted in a higher proportion of abdominal pain responders compared with the mNICE group (51% vs. 23%, P=0.008). Compared with baseline scores, the low FODMAP diet led to greater reductions in average daily scores of abdominal pain, bloating

  6. Vitamin D supplementation and fracture incidence in elderly persons : A randomized, placebo-controlled clinical trial

    NARCIS (Netherlands)

    Lips, Paul; Graafmans, Wilco C.; Ooms, Marcel E.; Bezemer, P. Dick; Bouter, Lex M.

    1996-01-01

    Objective: To determine whether vitamin D supplementation decreases the incidence of hip fractures and other peripheral bone fractures. Design: Prospective, double-blind trial. Setting: Community setting (Amsterdam and surrounding area). Patients: 2578 persons (1916 women, 662 men) 70 years of age

  7. Radiochemotherapy of locally advanced anal canal carcinoma: Prospective assessment of early impact on the quality of life (randomized trial ACCORD 03)

    International Nuclear Information System (INIS)

    Tournier-Rangeard, Laetitia; Mercier, Mariette; Peiffert, Didier; Gerard, Jean-Pierre; Romestaing, Pascale; Lemanski, Claire; Mirabel, Xavier; Pommier, Pascal; Denis, Bernard

    2008-01-01

    Background and purpose: The aim of this study was to prospectively assess the quality of life (QOL) of patients treated by concomitant chemo radiation for locally advanced anal canal carcinoma. Materials and methods: We report on a subgroup of 119 patients enrolled in a 306-patient therapeutic intensification prospective trial (ACCORD 03). This trial evaluated the impact on colostomy-free survival of induction chemotherapy and/or high dose radiotherapy (factorial design 2 * 2 treatment arms). QOL was assessed both before and 2 months after treatment using the EORTC QLQ-C30 questionnaire as well as a questionnaire relating to anal sphincter conservative treatment (AS-CT). Results: Compared to pre-treatment scores, patients reported significant improvement in their emotional function (+8.4 points p = 0.002), global health status (+5.9 points p = 0.0007), as well as a decrease in insomnia (-13.8 points p < 0.0001), constipation (-12.0 points p < 0.0001), appetite loss (-10.3 points p < 0.0001) and pain (-9.6 points p = 0.0002). The AS-CT degree of satisfaction with intestinal functions score was increased (+11.2 points p < 0.0001). Conclusion: This is the first prospective study comparing QOL of patients with advanced anal canal carcinoma, before and 2 months after conservative treatment. Two months after treatment, QOL was improved. Induction chemotherapy and/or high dose radiotherapy did not provide a negative impact on QOL

  8. Bevacizumab plus capecitabine in patients with progressive advanced well-differentiated neuroendocrine tumors of the gastro-intestinal (GI-NETs) tract (BETTER trial)--a phase II non-randomised trial.

    Science.gov (United States)

    Mitry, Emmanuel; Walter, Thomas; Baudin, Eric; Kurtz, Jean-Emmanuel; Ruszniewski, Philippe; Dominguez-Tinajero, Sophie; Bengrine-Lefevre, Leïla; Cadiot, Guillaume; Dromain, Clarisse; Farace, Françoise; Rougier, Philippe; Ducreux, Michel

    2014-12-01

    Gastro-intestinal neuroendocrine tumours (GI-NETs) are chemotherapy-resistant tumours. Bevacizumab, an inhibitor of vascular endothelial growth factor (VEGF), has shown promising results in several phase II trials of gastro-entero-pancreatic-NETs. We assessed bevacizumab combined with capecitabine, specifically in GI-NET patients. BEvacizumab in The Treament of neuroEndocrine tumoRs (BETTER) was a multicentre, open-label, non-randomised, two-group phase II trial. Here we present the group of patients with progressive, metastatic, well-differentiated GI-NETs. Patients Eastern Cooperative Oncology Group-performance status (ECOG-PS)⩽2, Ki-67 proliferation rate <15% and no prior systemic chemotherapy were treated with bevacizumab (7.5 mg/kg/q3w) and capecitabine (1000 mg/m2 twice daily, orally d1-14, resumed on d22) for 6-24 months. The primary end-point was progression-free survival (PFS); secondary end-points included overall survival (OS), response rate, safety and quality of life. Of the 49 patients included, 53% were men, median age was 60 years (41-82), primary tumour site was ileal in 82% patients and Ki-67 was <15% in 48 patients and not available for one patient. After a maximum of 24 month follow-up per patient, the median PFS by investigator assessment was 23.4 months [95% confidence interval (CI): 13.2; not reached] and the overall disease control rate was 88% (18% partial response, 70% stable disease). The 2-year survival rate was 85%. Median OS was not reached. The most frequent grade 3-4 adverse events were hypertension (31%), diarrhoea (14%) and hand-foot syndrome (10%). The combination of bevacizumab and capecitabine showed clinical activity and a manageable safety profile in the treatment of GI-NETs that warrant confirmation in a randomised phase III trial. Copyright © 2014 Elsevier Ltd. All rights reserved.

  9. Results of Laboratory Testing of Advanced Power Strips: Preprint

    Energy Technology Data Exchange (ETDEWEB)

    Earle, L.; Sparn, B.

    2012-08-01

    This paper describes the results of a laboratory investigation to evaluate the technical performance of advanced power strip (APS) devices when subjected to a range of home entertainment center and home office usage scenarios.

  10. Root coverage with connective tissue graft associated with coronally advanced flap or tunnel technique: a randomized, double-blind, mono-centre clinical trial

    NARCIS (Netherlands)

    Azaripour, Adriano; Kissinger, Maren; Farina, Vittorio Siro Leone; van Noorden, Cornelis J. F.; Gerhold-Ay, Aslihan; Willershausen, Brita; Cortellini, Pierpaolo

    2016-01-01

    Aim: The aim of this randomized clinical trial was to compare the coronally advanced flap (CAF) with the modified microsurgical tunnel technique (MMTT) for treatment of Miller class I and II recessions. Material and Methods: Forty patients with 71 gingival recessions were recruited and randomly

  11. Results of the in vitro ring trial:. Thorium and uranium isotopes in urine

    International Nuclear Information System (INIS)

    Hartmann, M.; Dalheimer, A.; Haenisch, K.

    2006-08-01

    On 22 September 2004 a workshop was held at the Berlin branch of the Federal Radiation Protection Office (BfS) on the in vitro ring trial ''Th isotopes and U isotopes in urine'' organised by the BfS head office for incorporation monitoring. The workshop was attended by 11 experts from the German, Austrian and Swiss incorporation measurement stations participating in the ring trial. The main focus of this second workshop was on the presentation of the results of the ring trial concerning Th and U isotopes in urine. According to paragraph 41 (8) of the Federal Radiation Protection Ordinance (StrlSchV 2001) one of the responsibilities of the head office for incorporation monitoring in terms of quality assurance is to have ring trials performed by the excretion analysis laboratories designated by the competent authorities as measurement stations. Section 5.2 of the Guideline on Requirements for Incorporation Monitoring Stations still in force (referred to in the following as the ''Requirements Guideline''/Guideline 1996) stipulates that incorporation measurement stations whose scope includes this type of measurement are obliged to participate in such ring trials. Inofficial and foreign incorporation measurement stations are also entitled to participate in ring trials organised by the head office. Ring trials may comprise either data acquisition or the dosimetric interpretation of data or both. By participating in ring trials measurement stations are supposed to demonstrate that the analysis and measurement methods they use are capable of supplying correct results with sufficient precision within the required time frame and of providing dosimetrically correct interpretations of activity increases

  12. Accelerated partial breast irradiation with external beam radiotherapy. First results of the German phase 2 trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, Oliver J.; Strnad, Vratislav; Stillkrieg, Wilhelm; Fietkau, Rainer [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany); Uter, Wolfgang [University Erlangen-Nuremberg, Dept. of Medical Informatics, Biometry and Epidemiology, Erlangen (Germany); Beckmann, Matthias W. [University Hospital Erlangen, Dept. of Gynecology, Erlangen (Germany)

    2017-01-15

    To evaluate the feasibility and efficacy of external beam three-dimensional (3D) conformal accelerated partial breast irradiation (APBI) for selected patients with early breast cancer. Between 2011 and 2016, 72 patients were recruited for this prospective phase 2 trial. Patients were eligible for APBI if they had histologically confirmed breast cancer or pure ductal carcinoma in situ (DCIS), a tumor diameter ≤3 cm, clear resection margins ≥2 mm, no axillary lymph node involvement, no distant metastases, tumor bed clips, and were aged ≥50 years. Patients were excluded if mammography showed a multicentric invasive growth pattern, or if they had residual diffuse microcalcifications postoperatively, an extensive intraductal component, or vessel invasion. Patients received 3D conformal external beam APBI with a total dose of 38 Gy in 10 fractions in 1-2 weeks. The trial had been registered at the German Clinical Trials Register, DRKS-ID: DRKS00004417. Median follow-up was 25.5 months (range 1-61 months). Local control was maintained in 71 of 72 patients. The 3-year local recurrence rate was 2.1% (95% confidence interval, CI: 0-6.1%). Early toxicity (grade 1 radiodermatitis) was seen in 34.7% (25/72). Late side effects ≥ grade 3 did not occur. Cosmetic results were rated as excellent/good in 96.7% (59/61). APBI with external beam radiotherapy techniques is feasible with low toxicity and, according to the results of the present and other studies, on the way to becoming a standard treatment option for a selected subgroup of patients. (orig.) [German] Untersuchung der Vertraeglichkeit und Sicherheit der externen, 3-D-konformalen akzelerierten Teilbrustbestrahlung (APBI) fuer ausgewaehlte Patientinnen mit einem fruehen Mammakarzinom. Von 2011 bis 2016 wurden 72 Patientinnen in diese prospektive Phase-2-Studie eingebracht. Einschlusskriterien waren ein histologisch gesichertes Mammakarzinom oder DCIS, ein Tumordurchmesser ≤ 3 cm, tumorfreie Resektionsraender ≥ 2

  13. Relation between breast cancer mortality and screening effectiveness: systematic review of the mammography trials

    DEFF Research Database (Denmark)

    Gøtzsche, Peter C

    2011-01-01

    The mammography screening trials have shown varying results. This could be because screening was better in some trials than in others at advancing the time of diagnosis. If so, more cancers would be identified in such trials relative to the control group, and fewer of the cancers would have reach...

  14. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...

  15. FY2016 Advanced Batteries R&D Annual Progress Report - Part 4 of 5

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    2017-08-31

    The Advanced Batteries research and development (R&D) subprogram within the DOE Vehicle Technologies Office (VTO) provides support and guidance for projects focusing on batteries for plug-in electric vehicles. Program targets focus on overcoming technical barriers to enable market success including: (1) significantly reducing battery cost, (2) increasing battery performance (power, energy, durability), (3) reducing battery weight & volume, and (4) increasing battery tolerance to abusive conditions such as short circuit, overcharge, and crush. This report describes the progress made on the research and development projects funded by the Battery subprogram in 2016. This section covers Advanced Battery Materials Research (BMR) part 1.

  16. Effects of vitamin D supplementation on insulin resistance and cardiometabolic risk factors in children with metabolic syndrome: a triple-masked controlled trial.

    Science.gov (United States)

    Kelishadi, Roya; Salek, Shadi; Salek, Mehdi; Hashemipour, Mahin; Movahedian, Mahsa

    2014-01-01

    This triple-masked controlled trial aimed to assess the effects of vitamin D supplementation on insulin resistance and cardiometabolic risk factors in obese children and adolescents. The study comprised 50 participants, aged 10 to 16 years, who were randomly assigned into two groups of equal number. In this 12-week trial, one group received oral vitamin D (300,000 IU) and the other group received placebo. Cardiometabolic risk factors, insulin resistance, and a continuous value of metabolic syndrome (cMetS) were determined. Statistical analysis was conducted after adjustment for covariate interactions. Overall, 21 patients in the vitamin D group and 22 in the placebo group completed the trial. No significant difference was observed in the baseline characteristics of the two groups. After the trial, in the vitamin D group, serum insulin and triglyceride concentrations, as well as HOM -IR and C-MetS decreased significantly, both when compared with the baseline and with the placebo group. No significant difference was observed when comparing total cholesterol, LDL-C, HDL-C, fasting blood glucose, and blood pressure. The present findings support the favorable effects of vitamin D supplementation on reducing insulin resistance and cardiometabolic risk factors in obese children. Copyright © 2013 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.

  17. Randomized controlled trial of the effects of vitamin D–fortified milk and bread on serum 25-hydroxyvitamin D concentrations in families in Denmark during winter: the VitmaD study1-3

    DEFF Research Database (Denmark)

    Madsen, Katja Howarth; Rasmussen, Lone Banke; Andersen, Rikke

    2013-01-01

    starting in September. The milk and bread replaced the participants’ usual consumptions of products. Results: Median (IQR) vitamin D intakes (habitual diet plus fortified products) were 9.4 μg/d (6.5, 12.3 μg/d) and 2.2 μg/d (1.5, 3.0 μg/d) in fortification and control groups, respectively. Geometric mean......Background: Vitamin D intakes are lower than dietary recommendations in most populations, and thus, a low vitamin D status is widespread, especially during winter. Objective: We investigated the effects of increasing vitamin D intake to the recommended amount by fortification of milk and bread...... on serum 25-hydroxyvitamin D [25(OH)D] concentrations in families during winter in Denmark. Design: The study was a randomized controlled trial in 782 children and adults (4–60 y old) recruited as 201 families. Families were randomly assigned to vitamin D–fortified or nonfortified milk and bread for 6 mo...

  18. Landscape of early clinical trials for childhood and adolescence cancer in Spain.

    Science.gov (United States)

    Bautista, F; Gallego, S; Cañete, A; Mora, J; Diaz de Heredia, C; Cruz, O; Fernández, J M; Rives, S; Madero, L; Castel, V; Cela, M E; Ramírez, G; Sábado, C; Acha, T; Astigarraga, I; Sastre, A; Muñoz, A; Guibelalde, M; Moreno, L

    2016-07-01

    Despite numerous advances, survival remains dismal for children and adolescents with poor prognosis cancers or those who relapse or are refractory to first line treatment. There is, therefore, a major unmet need for new drugs. Recent advances in the knowledge of molecular tumor biology open the door to more adapted therapies according to individual alterations. Promising results in the adult anticancer drug development have not yet been translated into clinical practice. We report the activity in early pediatric oncology trials in Spain. All members of the Spanish Society of Pediatric Hematology Oncology (SEHOP) were contacted to obtain information about early trials open in each center. 22 phase I and II trials were open as of May 2015: 15 for solid tumors (68 %) and 7 for hematological malignancies (32 %). Fourteen (64 %) were industry sponsored. Since 2010, four centers have joined the Innovative Therapies For Children With Cancer, an international consortium whose aim is developing novel therapies for pediatric cancers. A substantial number of studies have opened in these 5 years, improving the portfolio of trials for children. Results of recently closed trials show the contribution of Spanish investigators, the introduction of molecularly targeted agents and their benefits. Clinical trials are the way to evaluate new drugs, avoiding the use of off-label drugs that carry significant risks. The Spanish pediatric oncology community through the SEHOP is committed to develop and participate in collaborative academic trials, to favor the advancement and optimization of existing therapies in pediatric cancer.

  19. Vitamin D and type 2 diabetes.

    Science.gov (United States)

    Lips, Paul; Eekhoff, Marelise; van Schoor, Natasja; Oosterwerff, Mirjam; de Jongh, Renate; Krul-Poel, Yvonne; Simsek, Suat

    2017-10-01

    Vitamin D deficiency is associated with a decreased insulin release, insulin resistance and type 2 diabetes in experimental and epidemiological studies. Animal studies show that 1α,25-dihydroxyvitamin D 3 (1,25(OH) 2 D 3 ) stimulates the pancreatic β-cell to secrete insulin. The relationship between vitamin D deficiency and insulin resistance could develop through inflammation, as vitamin D deficiency is associated with increased inflammatory markers. In addition, genetic polymorphisms of vitamin D -related genes may predispose to impaired glycemic control and type 2 diabetes. Epidemiologic studies showed an association between low serum 25-hydroxyvitamin D 3 (25(OH)D 3 ) concentration and an increased risk for the metabolic syndrome and type 2 diabetes. This may be partly explained by an increased fat mass. A possible causal relationship between vitamin D deficiency and type 2 diabetes should be proven by randomized clinical trials showing that either type 2 diabetes can be prevented or insulin release and insulin sensitivity can be improved by vitamin D supplements. The results of randomized clinical trials on the effect of vitamin D versus placebo, sometimes combined with calcium, in patients with impaired glucose tolerance ("prediabetes") or type 2 diabetes are inconsistent. Some studies showed a slight decrease of fasting plasma glucose or improvement of insulin resistance, but often only in posthoc analyses. These effects are mainly visible in patients with vitamin D deficiency and impaired glucose tolerance at baseline. Meta-analyses of randomized clinical trials in general did not show significant effects of vitamin D supplementation on glycemic control. Currently, several large scale randomized clinical trials with vitamin D supplementation in doses of 1600-4000IU/d are ongoing with glycemic control or incidence of diabetes mellitus as outcome. Vitamin D deficiency needs to be prevented or cured, but until the results of these trials are published, high

  20. Effectiveness of Vitamin D Supplement Therapy in Chronic Stable Schizophrenic Male Patients: A Randomized Controlled Trial.

    Science.gov (United States)

    Sheikhmoonesi, Fatemeh; Zarghami, Mehran; Mamashli, Shima; Yazdani Charati, Jamshid; Hamzehpour, Romina; Fattahi, Samineh; Azadbakht, Rahil; Kashi, Zahra; Ala, Shahram; Moshayedi, Mona; Alinia, Habibollah; Hendouei, Narjes

    2016-01-01

    In this study, the aim was to determine whether adding vitamin D to the standard therapeutic regimen of schizophrenic male patients with inadequate vitamin D status could improve some aspects of the symptom burden or not. This study was an open parallel label randomized clinical trial. Eighty patients with chronic stable schizophrenia with residual symptoms and Vitamin D deficiency were recruited randomly and then received either 600000 IU Vitamin D injection once along with their antipsychotic regimen or with their antipsychotic regimen only. Serum vitamin D was measured twice: first at the baseline and again on the fourth month. Positive and Negative Syndrome Scale (PANSS) was assessed at the baseline and on the fourth month. During the study, the vitamin D serum changes in vitamin group and control group were 22.1 ± 19.9(95%CI = 15.9-28.8) and 0.2 ± 1.7(95%CI = 0.2-0.8) (ng/mL) (pvitamin D and control group respectively (p=0.5). The changes of PANSS negative subscale score (N) were -0.1 ± 0.7 (95%CI = -0.3-0.05) and -0.1 ± 0.5 (95%CI = -0.2-0.04) in vitamin D and control group respectively (p = 0.7) and there was a negative but not significant correlation between serum vitamin D level changes and PANSS negative subscale score (r = -0.04, p = 0.7). We did not find a relationship between serum vitamin D level changes and the improvement of negative and positive symptoms in schizophrenic patients and more randomized clinical trials are required to confirm our findings.

  1. Effect of a life review program for Chinese patients with advanced cancer: a randomized controlled trial.

    Science.gov (United States)

    Xiao, Huimin; Kwong, Enid; Pang, Samantha; Mok, Esther

    2013-01-01

    Empirical data suggest that life review is an effective psychospiritual intervention. However, it has not been applied to Chinese patients with advanced cancer, and its effects on this population remain unknown. The aim of the study was to determine the effect of a life review program on quality of life among Chinese patients with advanced cancer. In this prospective randomized controlled trial, a total of 80 patients were randomly assigned to the life review program group and the control group. The 3-weekly life review program included reviewing a life and formulating a life review booklet. Outcome data were assessed by a collector who was blinded to group assignment before and immediately after the program and at a 3-week follow-up. Significantly better scores in overall quality of life, support, negative emotions, sense of alienation, existential distress, and value of life were found in the life review group immediately after the program and at the 3-week follow-up. This study provides additional data on the potential role of a life review in improving quality of life, particularly psychospiritual well being; it also indicates that the life review program could enable Chinese patients with advanced cancer to express their views on life and death. The life review program offers advanced cancer patients an opportunity to integrate their whole life experiences and discuss end-of-life issues, which lays the ground for further active intervention in their psychospiritual distress. The program could be integrated into daily home care to enhance the psychospiritual well-being of Chinese patients with advanced cancer.

  2. Acute pancreatitis: recent advances through randomised trials.

    Science.gov (United States)

    van Dijk, Sven M; Hallensleben, Nora D L; van Santvoort, Hjalmar C; Fockens, Paul; van Goor, Harry; Bruno, Marco J; Besselink, Marc G

    2017-11-01

    Acute pancreatitis is one of the most common GI conditions requiring acute hospitalisation and has a rising incidence. In recent years, important insights on the management of acute pancreatitis have been obtained through numerous randomised controlled trials. Based on this evidence, the treatment of acute pancreatitis has gradually developed towards a tailored, multidisciplinary effort, with distinctive roles for gastroenterologists, radiologists and surgeons. This review summarises how to diagnose, classify and manage patients with acute pancreatitis, emphasising the evidence obtained through randomised controlled trials. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  3. Results from the Xylitol for Adult Caries Trial (X-ACT)

    Science.gov (United States)

    Bader, James D.; Vollmer, William M.; Shugars, Daniel A.; Gilbert, Gregg H.; Amaechi, Bennett T.; Brown, John P.; Laws, Reesa L.; Funkhouser, Kimberly A.; Makhija, Sonia K.; Ritter, André V.; Leo, Michael C.

    2013-01-01

    Background Although caries is prevalent in adults, few preventive therapies have been tested in adult populations. This randomized clinical trial evaluated the effectiveness of xylitol lozenges in preventing caries in elevated caries-risk adults. Methods X-ACT was a three-site placebo-controlled randomized trial. Participants (n=691) ages 21–80 consumed five 1.0 g xylitol or placebo lozenges daily for 33 months. Clinical examinations occurred at baseline, 12, 24 and 33 months. Results Xylitol lozenges reduced the caries increment 11%. This reduction, which represented less than one-third of a surface per year, was not statistically significant. There was no indication of a dose-response effect. Conclusions Daily use of xylitol lozenges did not result in a statistically or clinically significant reduction in 33-month caries increment among elevated caries-risk adults. Clinical Implications These results suggest that xylitol used as a supplement in adults does not significantly reduce their caries experience. PMID:23283923

  4. Mechanical design of a precision linear flexural stage for 3D x-ray diffraction microscope at the Advanced Photon Source

    Science.gov (United States)

    Shu, D.; Liu, W.; Kearney, S.; Anton, J.; Tischler, J. Z.

    2015-09-01

    The 3-D X-ray diffraction microscope is a new nondestructive tool for the three-dimensional characterization of mesoscopic materials structure. A flexural-pivot-based precision linear stage has been designed to perform a wire scan as a differential aperture for the 3-D diffraction microscope at the Advanced Photon Source, Argonne National Laboratory. The mechanical design and finite element analyses of the flexural stage, as well as its initial mechanical test results with laser interferometer are described in this paper.

  5. Preoperative hyperfractionated radiotherapy for locally advanced rectal cancers: a phase I-II trial

    International Nuclear Information System (INIS)

    Allal, Abdelkarim S.; Bieri, Sabine; Bruendler, Marie-Anne; Soravia, Claudio; Gertsch, Philippe; Bernier, Jacques; Morel, Philippe; Roth, Arnaud D.

    2002-01-01

    Purpose: To assess the toxicity, pathologic response rates, type of surgery, and oncologic results in a prospective Phase I-II trial using pure hyperfractionated radiotherapy (RT) preoperatively in locally advanced rectal cancer. Methods and Materials: Between September 1997 and April 2000, 50 patients with T3-T4 or N1 rectal cancers were treated preoperatively with 50 Gy (45 Gy to the pelvis and a 5-Gy tumor boost) in 40 fractions of 1.25 Gy during 4 weeks. The pretreatment tumor stage as determined by CT and endorectal ultrasonography (80% of patients) included 1 Stage T2 (2%), 45 T3 (90%), and 4 T4 (8%). Nodal involvement (N1) was documented in 26 patients (52%). Surgery was performed at a median interval of 45 days (range 26-114 days) after RT completion. Seventeen patients who presented with pT4 or pN1 and/or pM1 received 5-fluorouracil-based chemotherapy postoperatively. Results: All patients completed the RT schedule as planned. Severe acute toxicities included two Grade 3 skin reactions (4%) that did not require a break. The other acute toxicities were Grade 2 or less (skin, diarrhea, urinary, rectal tenesmus, and fatigue). A complete pathologic response was observed in 7 patients (14%), and microscopic residual cancer was found in 10 (20%). Of the 20 patients presenting with tumor located ≤6 cm from the anal verge, sphincter-saving surgery was performed in 14 (70%). At 3 years, the actuarial locoregional control rate was 90.5%, and the disease-free survival rate was 74.6%. At a median follow-up of 32 months, 4 patients (8%) presented with severe late complications (Grade 3-4) that might have been RT related (one rectovaginal fistula, two chronic perineal fistulas, and one bilateral ureteral stenosis). Conclusion: In locally advanced rectal cancer, preoperative hyperfractionated RT to a total dose of 50 Gy is feasible, with acceptable acute and late toxicity and an objective downstaging effect. In view of these results, this schedule might be used as a

  6. Isoquercetin as an Adjunct Therapy in Patients With Kidney Cancer Receiving First-Line Sunitinib (QUASAR: Results of a Phase I Trial

    Directory of Open Access Journals (Sweden)

    Carlo Buonerba

    2018-03-01

    Full Text Available Sunitinib is the most commonly prescribed drug for advanced renal cell carcinoma in the first-line setting and has been associated with multiple adverse events related to its on–and off–target effects, including hand and foot syndrome and fatigue. It was hypothesized that sunitinib-induced fatigue may be related to off target inhibition of the AMPK enzyme, which results in impairment of energy-producing processes at a systemic level. Quercetin is a naturally occurring flavonol with established AMPK-stimulating activity. While clinical use of quercetin is limited by its poor bio-availability, quercetin-3-O-β-d-glucopyranoside, that is isoquercetin, has an improved pharmacokinetic profile. On the grounds of the in vitro stimulatory activity with respect to AMPk, we hypothesized that oral isoquercetin could improve fatigue in kidney cancer patients receiving sunitinib. Given the lack of data on the safety of isoquercetin given concomitantly with sunitinib, we conducted a phase I trial to assess the safety of GMP manufactured isoquercetin given at two dose levels (450 and 900 mg a day. In the 12-patient study cohort included in this study, isoquercetin was administered concomitantly with 50 mg sunitinib for a median 81 days (IQR, 75.5, 86.5. None of the 12 patients required isoquercetin suspension or isoquercetin dose reduction because of adverse events. No abnormalities in ECG, heart or lower limbs doppler ultrasound were detected. A statistically significant improvement was reported for the FACIT fatigue score (6.8 points; 95% CI: 2.8–10.8; p = 0.002 and for the FACIT Adverse Events score (18.9 points; 95% CI: 9.1–28.8; p < 0.001 after isoquercetin consumption vs. baseline. In this phase I trial, isoquercetin was remarkably safe, with a preliminary signal of activity in terms of improvement of sunitinib adverse events.

  7. Isoquercetin as an Adjunct Therapy in Patients With Kidney Cancer Receiving First-Line Sunitinib (QUASAR): Results of a Phase I Trial.

    Science.gov (United States)

    Buonerba, Carlo; De Placido, Pietro; Bruzzese, Dario; Pagliuca, Martina; Ungaro, Paola; Bosso, Davide; Ribera, Dario; Iaccarino, Simona; Scafuri, Luca; Liotti, Antonietta; Romeo, Valeria; Izzo, Michela; Perri, Francesco; Casale, Beniamino; Grimaldi, Giuseppe; Vitrone, Francesca; Brunetti, Arturo; Terracciano, Daniela; Marinelli, Alfredo; De Placido, Sabino; Di Lorenzo, Giuseppe

    2018-01-01

    Sunitinib is the most commonly prescribed drug for advanced renal cell carcinoma in the first-line setting and has been associated with multiple adverse events related to its on-and off-target effects, including hand and foot syndrome and fatigue. It was hypothesized that sunitinib-induced fatigue may be related to off target inhibition of the AMPK enzyme, which results in impairment of energy-producing processes at a systemic level. Quercetin is a naturally occurring flavonol with established AMPK-stimulating activity. While clinical use of quercetin is limited by its poor bio-availability, quercetin-3-O-β-d-glucopyranoside, that is isoquercetin, has an improved pharmacokinetic profile. On the grounds of the in vitro stimulatory activity with respect to AMPk, we hypothesized that oral isoquercetin could improve fatigue in kidney cancer patients receiving sunitinib. Given the lack of data on the safety of isoquercetin given concomitantly with sunitinib, we conducted a phase I trial to assess the safety of GMP manufactured isoquercetin given at two dose levels (450 and 900 mg a day). In the 12-patient study cohort included in this study, isoquercetin was administered concomitantly with 50 mg sunitinib for a median 81 days (IQR, 75.5, 86.5). None of the 12 patients required isoquercetin suspension or isoquercetin dose reduction because of adverse events. No abnormalities in ECG, heart or lower limbs doppler ultrasound were detected. A statistically significant improvement was reported for the FACIT fatigue score (6.8 points; 95% CI: 2.8-10.8; p = 0.002) and for the FACIT Adverse Events score (18.9 points; 95% CI: 9.1-28.8; p < 0.001) after isoquercetin consumption vs. baseline. In this phase I trial, isoquercetin was remarkably safe, with a preliminary signal of activity in terms of improvement of sunitinib adverse events.

  8. Maternal vitamin D supplementation during pregnancy prevents vitamin D deficiency in the newborn: an open-label randomized controlled trial.

    Science.gov (United States)

    Rodda, C P; Benson, J E; Vincent, A J; Whitehead, C L; Polykov, A; Vollenhoven, B

    2015-09-01

    To determine whether maternal vitamin D supplementation, in the vitamin D deficient mother, prevents neonatal vitamin D deficiency. Open-label randomized controlled trial. Metropolitan Melbourne, Australia, tertiary hospital routine antenatal outpatient clinic. Seventy-eight women with singleton pregnancies with vitamin D deficiency/insufficiency (serum 25-OH Vit D l) at their first antenatal appointment at 12-16-week gestation were recruited. Participants were randomized to vitamin D supplementation (2000-4000 IU cholecalciferol) orally daily until delivery or no supplementation. The primary outcome was neonatal serum 25-OH vit D concentration at delivery. The secondary outcome was maternal serum 25-OH vit D concentration at delivery. Baseline mean maternal serum 25-OH vit D concentrations were similar (P = 0·9) between treatment (32 nmol/l, 95% confidence interval 26-39 nmol/l) and control groups (33 nmol/l, 95% CI 26-39 nmol/l). Umbilical cord serum 25-OH vit D concentrations at delivery were higher (P l, 95% CI; 70-91 nmol/l) compared with neonates of control group mothers (42 nmol/l, 95% CI; 34-50 nmol/l) with a strongly positive correlation between maternal serum 25-OH Vit D and umbilical cord serum 25-OH vit D concentrations at delivery (Spearman rank correlation coefficient 0·88; P l, 95% CI; 62-81 nmol/l) compared with the control group (36 nmol/l, 95% CI; 29-42 nmol/l). Vitamin D supplementation of vitamin D deficient pregnant women prevents neonatal vitamin D deficiency. © 2015 John Wiley & Sons Ltd.

  9. Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2014.

    Science.gov (United States)

    Deane, Bryan R; Porkess, Sheuli

    2018-07-01

    The objective of this study was to assess the timely disclosure of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2014. This is the final extension of three previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012 and 2013. The original study found that over a three-year period over three-quarters of all trials were disclosed within 12 months and almost 90% were disclosed by the end of the study (31 January 2013). The extension studies (2012 and 2013 approvals) both showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% and 93% respectively by the end of the studies. The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2014, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2016. The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2016 (end of survey). Of the completed trials associated with 32 new medicines licensed to 22 different companies in 2014, results of 93% (505/542) had been disclosed within 12 months, and results of 96% (518/542) had been disclosed by 31 July 2016. The disclosure rate within 12 months of 93% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 96% indicates that the improvement in transparency

  10. Clinical Trial Results Summary for Laypersons: A User Testing Study.

    Science.gov (United States)

    Raynor, D K; Myers, L; Blackwell, K; Kress, B; Dubost, A; Joos, A

    2018-01-01

    To apply "user testing" to maximize readability and acceptability of a Clinical Trial Results Laypersons Summary-a new European requirement. "User testing" (using questionnaire and semistructured interview) assessed whether people could find and understand key points. Findings were used to improve content and design, prior to retesting. Participants had a range of levels of health literacy and there was a higher education group. Participants accessed the summary on screen. In round 1 we tested 12 points of information. In round 2 a revised summary addressing round 1 findings was tested, leading to a third final version. In round 1, 2 of 12 points of information did not reach the target and interviews raised further format and content issues (some distracting technical explanations and inability to find or understand the 2 main study purposes). These findings informed revisions for the version tested in round 2, with 2 different points not reaching the target (inclusion criteria relating to duration of seasonal allergies and how researchers found out about participants' symptoms). Identified problems in both rounds were addressed and reflected in the final version. Despite improvements, participants did not consistently understand that summaries were intended for the public, or to only interpret results of single trials in the context of additional trials. All readers, including those with higher education, found the clear and straightforward language acceptable. Applying "user testing" resulted in a largely health-literate summary suitable for people across a range of backgrounds.

  11. Advanced Monte Carlo procedure for the IFMIF d-Li neutron source term based on evaluated cross section data

    International Nuclear Information System (INIS)

    Simakov, S.P.; Fischer, U.; Moellendorff, U. von; Schmuck, I.; Konobeev, A.Yu.; Korovin, Yu.A.; Pereslavtsev, P.

    2002-01-01

    A newly developed computational procedure is presented for the generation of d-Li source neutrons in Monte Carlo transport calculations based on the use of evaluated double-differential d+ 6,7 Li cross section data. A new code M c DeLicious was developed as an extension to MCNP4C to enable neutronics design calculations for the d-Li based IFMIF neutron source making use of the evaluated deuteron data files. The M c DeLicious code was checked against available experimental data and calculation results of M c DeLi and MCNPX, both of which use built-in analytical models for the Li(d, xn) reaction. It is shown that M c DeLicious along with newly evaluated d+ 6,7 Li data is superior in predicting the characteristics of the d-Li neutron source. As this approach makes use of tabulated Li(d, xn) cross sections, the accuracy of the IFMIF d-Li neutron source term can be steadily improved with more advanced and validated data

  12. Advanced Monte Carlo procedure for the IFMIF d-Li neutron source term based on evaluated cross section data

    CERN Document Server

    Simakov, S P; Moellendorff, U V; Schmuck, I; Konobeev, A Y; Korovin, Y A; Pereslavtsev, P

    2002-01-01

    A newly developed computational procedure is presented for the generation of d-Li source neutrons in Monte Carlo transport calculations based on the use of evaluated double-differential d+ sup 6 sup , sup 7 Li cross section data. A new code M sup c DeLicious was developed as an extension to MCNP4C to enable neutronics design calculations for the d-Li based IFMIF neutron source making use of the evaluated deuteron data files. The M sup c DeLicious code was checked against available experimental data and calculation results of M sup c DeLi and MCNPX, both of which use built-in analytical models for the Li(d, xn) reaction. It is shown that M sup c DeLicious along with newly evaluated d+ sup 6 sup , sup 7 Li data is superior in predicting the characteristics of the d-Li neutron source. As this approach makes use of tabulated Li(d, xn) cross sections, the accuracy of the IFMIF d-Li neutron source term can be steadily improved with more advanced and validated data.

  13. Effect of vitamin D supplementation on cardiometabolic risks and health-related quality of life among urban premenopausal women in a tropical country--a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Mazliza Ramly

    Full Text Available BACKGROUND: Many observational studies linked vitamin D to cardiometabolic risks besides its pivotal role in musculoskeletal diseases, but evidence from trials is lacking and inconsistent. AIM: To determine whether Vitamin D supplementation in urban premenopausal women with vitamin D deficiency can improve cardiometabolic risks and health-related quality of life (HRQOL. DESIGN: A double-blind randomized controlled trial was conducted in Kuala Lumpur, Malaysia. A total of 192 vitamin D deficient (0.05 between two groups. There was a small but significant improvement in HRQOL in the components of vitality (mean difference: 5.041; 95% CI: 0.709 to 9.374 and mental component score (mean difference: 2.951; 95% CI: 0.573 to 5.329 in the intervention group compared to placebo group. CONCLUSION: Large and less frequent dosage vitamin D supplementation was safe and effective in the achievement of vitamin D sufficiency. However, there was no improvement in measured cardiometabolic risk factors in premenopausal women. Conversely vitamin D supplementation improves some components of HRQOL. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12612000452897.

  14. Randomized trials and quality assurance in gastric cancer surgery.

    Science.gov (United States)

    Dikken, Johan L; Cats, Annemieke; Verheij, Marcel; van de Velde, Cornelis J H

    2013-03-01

    A D2 lymphadenectomy can be considered standard of surgical care for advanced resectable gastric cancer. Currently, several multimodality strategies are used, including postoperative monochemotherapy in Asia, postoperative chemoradiotherapy in the United States, and perioperative chemotherapy in Europe. As the majority of gastric cancer patients are treated outside the framework of clinical trials, quality assurance programs, including referral to high-volume centers and clinical auditing are needed to improve gastric cancer care on a nationwide level. Copyright © 2012 Wiley Periodicals, Inc.

  15. Results of modeling advanced BWR fuel designs using CASMO-4

    International Nuclear Information System (INIS)

    Knott, D.; Edenius, M.

    1996-01-01

    Advanced BWR fuel designs from General Electric, Siemens and ABB-Atom have been analyzed using CASMO-4 and compared against fission rate distributions and control rod worths from MCNP. Included in the analysis were fuel storage rack configurations and proposed mixed oxide (MOX) designs. Results are also presented from several cycles of SIMULATE-3 core follow analysis, using nodal data generated by CASMO-4, for cycles in transition from 8x8 designs to advanced fuel designs. (author)

  16. Advanced worker protection system

    International Nuclear Information System (INIS)

    Caldwell, B.; Duncan, P.; Myers, J.

    1995-01-01

    The Department of Energy (DOE) is in the process of defining the magnitude and diversity of Decontamination and Decommissioning (D ampersand D) obligations at its numerous sites. The DOE believes that existing technologies are inadequate to solve many challenging problems such as how to decontaminate structures and equipment cost effectively, what to do with materials and wastes generated, and how to adequately protect workers and the environment. Preliminary estimates show a tremendous need for effective use of resources over a relatively long period (over 30 years). Several technologies are being investigated which can potentially reduce D ampersand D costs while providing appropriate protection to DOE workers. The DOE recognizes that traditional methods used by the EPA in hazardous waste site clean up activities are insufficient to provide the needed protection and worker productivity demanded by DOE D ampersand D programs. As a consequence, new clothing and equipment which can adequately protect workers while providing increases in worker productivity are being sought for implementation at DOE sites. This project will result in the development of an Advanced Worker Protection System (AWPS). The AWPS will be built around a life support backpack that uses liquid air to provide cooling as well as breathing gas to the worker. The backpack will be combined with advanced protective garments, advanced liquid cooling garment, respirator, communications, and support equipment to provide improved worker protection, simplified system maintenance, and dramatically improve worker productivity through longer duration work cycles. Phase I of the project has resulted in a full scale prototype Advanced Worker Protection Ensemble (AWPE, everything the worker will wear), with sub-scale support equipment, suitable for integrated testing and preliminary evaluation. Phase II will culminate in a full scale, certified, pre-production AWPS and a site demonstration

  17. Advanced worker protection system

    Energy Technology Data Exchange (ETDEWEB)

    Caldwell, B.; Duncan, P.; Myers, J.

    1995-12-01

    The Department of Energy (DOE) is in the process of defining the magnitude and diversity of Decontamination and Decommissioning (D&D) obligations at its numerous sites. The DOE believes that existing technologies are inadequate to solve many challenging problems such as how to decontaminate structures and equipment cost effectively, what to do with materials and wastes generated, and how to adequately protect workers and the environment. Preliminary estimates show a tremendous need for effective use of resources over a relatively long period (over 30 years). Several technologies are being investigated which can potentially reduce D&D costs while providing appropriate protection to DOE workers. The DOE recognizes that traditional methods used by the EPA in hazardous waste site clean up activities are insufficient to provide the needed protection and worker productivity demanded by DOE D&D programs. As a consequence, new clothing and equipment which can adequately protect workers while providing increases in worker productivity are being sought for implementation at DOE sites. This project will result in the development of an Advanced Worker Protection System (AWPS). The AWPS will be built around a life support backpack that uses liquid air to provide cooling as well as breathing gas to the worker. The backpack will be combined with advanced protective garments, advanced liquid cooling garment, respirator, communications, and support equipment to provide improved worker protection, simplified system maintenance, and dramatically improve worker productivity through longer duration work cycles. Phase I of the project has resulted in a full scale prototype Advanced Worker Protection Ensemble (AWPE, everything the worker will wear), with sub-scale support equipment, suitable for integrated testing and preliminary evaluation. Phase II will culminate in a full scale, certified, pre-production AWPS and a site demonstration.

  18. The trials methodological research agenda: results from a priority setting exercise

    Science.gov (United States)

    2014-01-01

    Background Research into the methods used in the design, conduct, analysis, and reporting of clinical trials is essential to ensure that effective methods are available and that clinical decisions made using results from trials are based on the best available evidence, which is reliable and robust. Methods An on-line Delphi survey of 48 UK Clinical Research Collaboration registered Clinical Trials Units (CTUs) was undertaken. During round one, CTU Directors were asked to identify important topics that require methodological research. During round two, their opinion about the level of importance of each topic was recorded, and during round three, they were asked to review the group’s average opinion and revise their previous opinion if appropriate. Direct reminders were sent to maximise the number of responses at each round. Results are summarised using descriptive methods. Results Forty one (85%) CTU Directors responded to at least one round of the Delphi process: 25 (52%) responded in round one, 32 (67%) responded in round two, 24 (50%) responded in round three. There were only 12 (25%) who responded to all three rounds and 18 (38%) who responded to both rounds two and three. Consensus was achieved amongst CTU Directors that the top three priorities for trials methodological research were ‘Research into methods to boost recruitment in trials’ (considered the highest priority), ‘Methods to minimise attrition’ and ‘Choosing appropriate outcomes to measure’. Fifty other topics were included in the list of priorities and consensus was reached that two topics, ‘Radiotherapy study designs’ and ‘Low carbon trials’, were not priorities. Conclusions This priority setting exercise has identified the research topics felt to be most important to the key stakeholder group of Directors of UKCRC registered CTUs. The use of robust methodology to identify these priorities will help ensure that this work informs the trials methodological research agenda, with

  19. Efficacy of targeted therapy for advanced renal cell carcinoma: A systematic review and meta-analysis of randomized controlled trials

    Directory of Open Access Journals (Sweden)

    Chao Wei

    Full Text Available ABSTRACT We conducted a systematic review and meta-analysis of the literature on the efficacy of the targeted therapies in the treatment of advanced RCC and, via an indirect comparison, to provide an optimal treatment among these agents. A systematic search of Medline, Scopus, Cochrane Library and Clinical Trials unpublished was performed up to Jan 1, 2015 to identify eligible randomized trials. Outcomes of interest assessing a targeted agent included progression free survival (PFS, overall survival (OS and objective response rate (ORR. Thirty eligible randomized controlled studies, total twentyfourth trails (5110 cases and 4626 controls were identified. Compared with placebo and IFN-α, single vascular epithelial growth factor (receptor tyrosine kinase inhibitor and mammalian target of rapamycin agent (VEGF(r-TKI & mTOR inhibitor were associated with improved PFS, improved OS and higher ORR, respectively. Comparing sorafenib combination vs sorafenib, there was no significant difference with regard to PFS and OS, but with a higher ORR. Comparing single or combination VEGF(r-TKI & mTOR inhibitor vs BEV + IFN-α, there was no significant difference with regard to PFS, OS, or ORR. Our network ITC meta-analysis also indicated a superior PFS of axitinib and everolimus compared to sorafenib. Our data suggest that targeted therapy with VEGF(r-TKI & mTOR inhibitor is associated with superior efficacy for treating advanced RCC with improved PFS, OS and higher ORR compared to placebo and IFN-α. In summary, here we give a comprehensive overview of current targeted therapies of advanced RCC that may provide evidence for the adequate targeted therapy selecting.

  20. Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

    Science.gov (United States)

    Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

    2016-01-28

    Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome

  1. Advanced mobile satellite communications system using Ka and MM-wave bands in Japan's R and D satellite project

    Science.gov (United States)

    Isobe, Shunkichi; Ohmori, Shingo; Hamamoto, Naokazu; Yamamoto, Minoru

    1991-01-01

    Communications Research Laboratory (CRL) studied an advanced mobile satellite communications system using Ka and millimeter-wave bands in the R&D Satellite project. The project started in 1990 and the satellite will be launched in 1997. On-board multi-beam interconnecting is one of basic functions to realize one-hop connection among Very Small Aperture Terminals (VSATs), mobile, and hand-held terminals in future mobile satellite communications system. An Intermediate Frequency (IF) filter bank and regenerative transponder are suitable for this function. The transponder configuration of an advanced mobile communications mission of the R&D Satellite for experiment is shown. High power transmitters of Ka and millimeter-wave bands, a 3x3 IF filter band and Single Channel Per Carrier/Time Division Multiplexing (SCPC/TDM) regenerative MODEMS, which will be boarded on the R&D Satellite, are being developed for the purpose of studying the feasibility of advanced mobile communications system.

  2. PAM50 breast cancer intrinsic subtypes and effect of gemcitabine in advanced breast cancer patients

    DEFF Research Database (Denmark)

    Jørgensen, Charlotte Levin Tykjær; Nielsen, Torsten O; Bjerre, Karsten D

    2014-01-01

    BACKGROUND: In vitro studies suggest basal breast cancers are more sensitive to gemcitabine relative to other intrinsic subtypes. The main objective of this study was to use specimens from a randomized clinical trial to evaluate whether the basal-like subtype identifies patients with advanced...... breast cancer who benefit from gemcitabine plus docetaxel (GD) compared to single agent docetaxel (D). MATERIAL AND METHODS: From patients randomly assigned to GD or D, RNA was isolated from archival formalin-fixed, paraffin-embedded primary breast tumor tissue and used for PAM50 intrinsic subtyping...... chemotherapy were analyzed by the Kaplan-Meier method, and Cox proportional hazards regression models. Data analysis was performed independently by the Danish Breast Cancer Cooperative Group (DBCG) statistical core and all statistical tests were two-sided. RESULTS: RNA from 270 patients was evaluable; 84...

  3. True fir-hemlock spacing trials: design and first results.

    Science.gov (United States)

    Robert O. Curtis; Gary W. Clendenen; Jan A. Henderson

    2000-01-01

    A series of 18 precommercial thinning trials was established in true fir-hemlock stands in the Olympic Mountains and along the west side of the Cascade Range in Washington and Oregon from 1987 through 1994. This paper documents establishment of these installations and presents some preliminary observations and results. Substantial differences in growth rates in height...

  4. Radiotherapy with concomitant chemotherapy superior to radiotherapy alone in the treatment of locally advanced anal cancer: results of a phase III randomized trial of the EORTC radiotherapy and gastrointestinal tract cooperative groups

    International Nuclear Information System (INIS)

    Bartelink, H.; Roelofsen, F.; Bosset, J.F.; Eschwege, F.; Rougier, Ph.; Peiffert, D.; Glabbeke, M. van; Pierart, M.

    1996-01-01

    Purpose: To investigate the potential gain of the concomitant use of radiotherapy and chemotherapy in improving local control and reducing the need for colostomy, a randomized phase-III trial was performed in patients with locally advanced anal cancer. Material and methods: In the period 1987-1994 110 patients were randomized between radiotherapy alone and a combination of radiotherapy and chemotherapy. The patients had tumors larger than 4 cm, or T 3-4 N 0-3 , or T 1-2 N 1-3 anal cancer. Radiotherapy consisted of 45 Gy given in 5 weeks, with a daily dose of 1.8 Gy. After a rest period of 6 weeks a boost of 15 Gy or 20 Gy was given in case of partial or complete response respectively. Chemotherapy was given during radiotherapy, 750 mg/m2 daily as continuous infusion on day 1-5 and 29-33, a single dose of Mitomycin C 15 mg/m 2 was administered on day 1. Results: The addition of chemotherapy to radiotherapy has resulted in an increase in the complete remission rate from 54% to 80%, and from 83% to 94% if results are considered after surgical resections. This has led to a significant improvement in loco-regional control and colostomy free survival (P=0.04, P=0.003 resp.) both in favor of the combined modality treatment. No significant difference was found when severe side effects were considered. The survival rate remained similar in both treatment arms. Skin ulceration, nodal involvement and sex were the most important prognostic factors for both local control and survival. These remained significant after multivariate analysis. The improvement seen in local control by adding chemotherapy to radiotherapy remained also significant after adjusting for prognostic factors in the multivariate analysis. Conclusions: The concomitant use of radiotherapy and chemotherapy resulted in an improved local control rate and a reduction in the need for colostomy in patients with locally advanced anal cancer

  5. Clinical Trials

    Medline Plus

    Full Text Available ... medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these ... trials are a key research tool for advancing medical knowledge and patient care. ...

  6. Abemaciclib: a CDK4/6 inhibitor for the treatment of HR+/HER2– advanced breast cancer

    Directory of Open Access Journals (Sweden)

    Corona SP

    2018-02-01

    Full Text Available Silvia Paola Corona,1 Daniele Generali2 1Radiation Oncology Department, Peter MacCallum Cancer Centre, Bentleigh East, VIC, Australia; 2Department of Medical, Surgery and Health Sciences, University of Trieste, Trieste, Italy Abstract: Although early breast cancer (BC is highly curable, advanced or metastatic disease poses numerous challenges in terms of medical management and treatment decisions and is associated with significantly worse prognosis. Among the new targeted agents, anticancer drugs exploiting the cell-cycle machinery have shown great potential in preclinical studies. CDK4/6 inhibitors target the cyclin D/CDK/retinoblastoma signaling pathway, inducing cell-cycle arrest, reduced cell viability and tumor shrinking. As the cyclin D/CDK complex is activated downstream of estrogen signaling, the combination of CDK4/6 inhibitors with standard endocrine therapies represents a rational approach to elicit synergic antitumor activity in hormone receptor-positive BC. The results of clinical trials have indeed confirmed the superiority of the combination of CDK4/6 inhibitors plus endocrine therapies over endocrine therapy alone. Currently approved are three compounds that exhibit similar structural characteristics as well as biological and clinical activities. Abemaciclib is the latest CDK4/6 inhibitor approved by the US Food and Drug Administration (FDA in view of the results of the MONARCH 1 and 2 trials. Further trials are ongoing as other important questions await response. In this review, we focus on abemaciclib to examine preclinical and clinical results, describing current therapeutic indications, open questions and ongoing clinical trials. Keywords: CDK4/6 inhibitor, abemaciclib, breast cancer, hormone receptor-positive BC, metastatic BC, mBC

  7. Field trials results of guided wave tomography

    International Nuclear Information System (INIS)

    Volker, Arno; Zon, Tim van; Leden, Edwin van der

    2015-01-01

    Corrosion is one of the industries major issues regarding the integrity of assets. Guided wave travel time tomography is a method capable of providing an absolute wall thickness map. This method is currently making the transition from the laboratory to the field. For this purpose a dedicated data acquisition system and special purpose EMAT sensor rings have been developed. The system can be deployed for permanent monitoring and inspections. Field trials have been conducted on various pipes with different diameters, containing either liquid or gas. The main focus has been on pipe supports. The results demonstrate the successful operation of the technology in the field. Expected corrosion damage was clearly visible on the produced results enabling asset owner to make calculated decisions on the pipelines safety, maintenance and operations

  8. Field trials results of guided wave tomography

    Science.gov (United States)

    Volker, Arno; van Zon, Tim; van der Leden, Edwin

    2015-03-01

    Corrosion is one of the industries major issues regarding the integrity of assets. Guided wave travel time tomography is a method capable of providing an absolute wall thickness map. This method is currently making the transition from the laboratory to the field. For this purpose a dedicated data acquisition system and special purpose EMAT sensor rings have been developed. The system can be deployed for permanent monitoring and inspections. Field trials have been conducted on various pipes with different diameters, containing either liquid or gas. The main focus has been on pipe supports. The results demonstrate the successful operation of the technology in the field. Expected corrosion damage was clearly visible on the produced results enabling asset owner to make calculated decisions on the pipelines safety, maintenance and operations.

  9. Trial-Based Cost-Utility Analysis of Icotinib versus Gefitinib as Second-Line Therapy for Advanced Non-Small Cell Lung Cancer in China.

    Science.gov (United States)

    Zhang, Chunxiang; Zhang, Hongmei; Shi, Jinning; Wang, Dong; Zhang, Xiuwei; Yang, Jian; Zhai, Qizhi; Ma, Aixia

    2016-01-01

    Our objective is to compare the cost-utility of icotinib and gefitinib for the second-line treatment of advanced non-small cell lung cancer (NSCLC) from the perspective of the Chinese healthcare system. Model technology was applied to assess the data of randomized clinical trials and the direct medical costs from the perspective of the Chinese healthcare system. Five-year quality-adjusted life years (QALYs) and incremental cost-utility ratios (ICURs) were calculated. One-way and probabilistic sensitivity analyses (PSA) were performed. Our model suggested that the median progression-free survival (PFS) was 4.2 months in the icotinib group and 3.5 months in the gefitinib group while they were 4.6 months and 3.4 months, respectively, in the trials. The 5-year QALYs was 0.279 in the icotinib group and 0.269 in the gefitinib group, and the according medical costs were $10662.82 and $13127.57. The ICUR/QALY of icotinib versus gefitinib presented negative in this study. The most sensitive parameter to the ICUR was utility of PFS, ranging from $-1,259,991.25 to $-182,296.61; accordingly the icotinib treatment consistently represented a dominant cost-utility strategy. The icotinib strategy, as a second-line therapy for advanced NSCLC patients in China, is the preferred strategy relative to gefitinib because of the dominant cost-utility. In addition, icotinib shows a good curative effect and safety, resulting in a strong demand for the Chinese market.

  10. Trial-Based Cost-Utility Analysis of Icotinib versus Gefitinib as Second-Line Therapy for Advanced Non-Small Cell Lung Cancer in China.

    Directory of Open Access Journals (Sweden)

    Chunxiang Zhang

    Full Text Available Our objective is to compare the cost-utility of icotinib and gefitinib for the second-line treatment of advanced non-small cell lung cancer (NSCLC from the perspective of the Chinese healthcare system.Model technology was applied to assess the data of randomized clinical trials and the direct medical costs from the perspective of the Chinese healthcare system. Five-year quality-adjusted life years (QALYs and incremental cost-utility ratios (ICURs were calculated. One-way and probabilistic sensitivity analyses (PSA were performed.Our model suggested that the median progression-free survival (PFS was 4.2 months in the icotinib group and 3.5 months in the gefitinib group while they were 4.6 months and 3.4 months, respectively, in the trials. The 5-year QALYs was 0.279 in the icotinib group and 0.269 in the gefitinib group, and the according medical costs were $10662.82 and $13127.57. The ICUR/QALY of icotinib versus gefitinib presented negative in this study. The most sensitive parameter to the ICUR was utility of PFS, ranging from $-1,259,991.25 to $-182,296.61; accordingly the icotinib treatment consistently represented a dominant cost-utility strategy.The icotinib strategy, as a second-line therapy for advanced NSCLC patients in China, is the preferred strategy relative to gefitinib because of the dominant cost-utility. In addition, icotinib shows a good curative effect and safety, resulting in a strong demand for the Chinese market.

  11. FY2016 Advanced Batteries R&D Annual Progress Report - Part 5 of 5

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    2017-08-31

    The Advanced Batteries research and development (R&D) subprogram within the DOE Vehicle Technologies Office (VTO) provides support and guidance for projects focusing on batteries for plug-in electric vehicles. Program targets focus on overcoming technical barriers to enable market success including: (1) significantly reducing battery cost, (2) increasing battery performance (power, energy, durability), (3) reducing battery weight & volume, and (4) increasing battery tolerance to abusive conditions such as short circuit, overcharge, and crush. This report describes the progress made on the research and development projects funded by the Battery subprogram in 2016. This section cover Advanced Battery Materials Research (BMR) part 2, Battery500 Innovation Centers project summaries, and appendices.

  12. Comparison of Analysis Results Between 2D/1D Synthesis and RAPTOR-M3G in the Korea Standard Nuclear Plant (KSNP

    Directory of Open Access Journals (Sweden)

    Lim Mi Joung

    2016-01-01

    Full Text Available The 2D/1D synthesis methodology has been used to calculate the fast neutron (E > 1.0 MeV exposure to the beltline region of the reactor pressure vessel. This method uses the DORT 3.1 discrete ordinates code and the BUGLE-96 cross-section library based on ENDF/B-VI. RAPTOR-M3G (RApid Parallel Transport Of Radiation-Multiple 3D Geometries which performs full 3D calculations was developed and is based on domain decomposition algorithms, where the spatial and angular domains are allocated and processed on multi-processor computer architecture. As compared to traditional single-processor applications, this approach reduces the computational load as well as the memory requirement per processor. Both methods are applied to surveillance test results for the Korea Standard Nuclear Plant (KSNP-OPR (Optimized Power Reactor 1000 MW. The objective of this paper is to compare the results of the KSNP surveillance program between 2D/1D synthesis and RAPTOR-M3G. Each operating KSNP has a reactor vessel surveillance program consisting of six surveillance capsules located between the core and the reactor vessel in the downcomer region near the reactor vessel wall. In addition to the In-Vessel surveillance program, an Ex-Vessel Neutron Dosimetry (EVND program has been implemented. In order to estimate surveillance test results, cycle-specific forward transport calculations were performed by 2D/1D synthesis and by RAPTOR-M3G. The ratio between measured and calculated (M/C reaction rates will be discussed. The current plan is to install an EVND system in all of the Korea PWRs including the new reactor type, APR (Advanced Power Reactor 1400 MW. This work will play an important role in establishing a KSNP-specific database of surveillance test results and will employ RAPTOR-M3G for surveillance dosimetry location as well as positions in the KSNP reactor vessel.

  13. Effects of induction docetaxel, platinum, and fluorouracil chemotherapy in patients with stage III or IVA/B nasopharyngeal cancer treated with concurrent chemoradiation therapy: Final results of 2 parallel phase 2 clinical trials.

    Science.gov (United States)

    Kong, Lin; Zhang, Youwang; Hu, Chaosu; Guo, Ye; Lu, Jiade J

    2017-06-15

    The effects of docetaxel, platinum, and fluorouracil (TPF) induction chemotherapy plus concurrent chemoradiotherapy (CCRT) on locoregionally advanced nasopharyngeal cancer (NPC) are unclear. This study examined the long-term outcomes of the addition of this regimen to CCRT for stage III and IVA/B NPC. Two parallel, single-arm phase 2 trials were performed synchronously to evaluate the efficacy and toxicity of TPF-based induction chemotherapy in patients with stage III or IVA/B NPC. The induction chemotherapy, which preceded standard intensity-modulated radiation therapy/platinum-based chemoradiation, consisted of 3 cycles of docetaxel (75 mg/m 2 on day 1), cisplatin (75 mg/m 2 on day 1), and a continuous infusion of fluorouracil (500 mg/m 2 /d on days 1-5) every 4 weeks. The primary endpoint for both trials was 5-year overall survival (OS). Between January 2007 and July 2010, 52 eligible patients with stage III NPC and 64 eligible patients with nonmetastatic stage IV NPC were accrued to the 2 trials. With a median follow-up of 67 months, the 5-year OS, progression-free survival, distant metastasis-free survival, and local progression-free survival (LPFS) rates were all improved in comparison with historical benchmarks for patients with stage III or IVA/IVB NPC. Multivariate analyses indicated that T and N classifications (T1/T2 vs T3/T4 and N3 vs N0-N2) were the only significant prognosticators for OS. The number of induction chemotherapy cycles was the only significant prognostic factor for predicting LPFS. TPF-based induction chemotherapy appears to significantly improve outcomes in comparison with historical data when it is administered before CCRT for locoregionally advanced NPC. A phase 3 trial is currently being performed to confirm this benefit. Cancer 2017;123:2258-2267. © 2017 American Cancer Society. © 2017 American Cancer Society.

  14. L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN - a randomized multicentre trial

    Directory of Open Access Journals (Sweden)

    Kraft Matthias

    2012-07-01

    Full Text Available Abstract Background Cachexia, a >10% loss of body-weight, is one factor determining the poor prognosis of pancreatic cancer. Deficiency of L-Carnitine has been proposed to cause cancer cachexia. Findings We screened 152 and enrolled 72 patients suffering from advanced pancreatic cancer in a prospective, multi-centre, placebo-controlled, randomized and double-blinded trial to receive oral L-Carnitine (4 g or placebo for 12 weeks. At entry patients reported a mean weight loss of 12 ± 2,5 (SEM kg. During treatment body-mass-index increased by 3,4 ± 1,4% under L-Carnitine and decreased (−1,5 ± 1,4% in controls (p  Conclusion While these data are preliminary and need confirmation they indicate that patients with pancreatic cancer may have a clinically relevant benefit from the inexpensive and well tolerated oral supplementation of L-Carnitine.

  15. Palbociclib Combined with Fulvestrant in Premenopausal Women with Advanced Breast Cancer and Prior Progression on Endocrine Therapy: PALOMA-3 Results.

    Science.gov (United States)

    Loibl, Sibylle; Turner, Nicholas C; Ro, Jungsil; Cristofanilli, Massimo; Iwata, Hiroji; Im, Seock-Ah; Masuda, Norikazu; Loi, Sherene; André, Fabrice; Harbeck, Nadia; Verma, Sunil; Folkerd, Elizabeth; Puyana Theall, Kathy; Hoffman, Justin; Zhang, Ke; Bartlett, Cynthia Huang; Dowsett, Mitchell

    2017-09-01

    The efficacy and safety of palbociclib, a cyclin-dependent kinase 4/6 inhibitor, combined with fulvestrant and goserelin was assessed in premenopausal women with advanced breast cancer (ABC) who had progressed on prior endocrine therapy (ET). One hundred eight premenopausal endocrine-refractory women ≥18 years with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) ABC were among 521 women randomized 2:1 (347:174) to fulvestrant (500 mg) ± goserelin with either palbociclib (125 mg/day orally, 3 weeks on, 1 week off) or placebo. This analysis assessed whether the overall tolerable safety profile and significant progression-free survival (PFS) improvement extended to premenopausal women. Potential drug-drug interactions (DDIs) and ovarian suppression with goserelin were assessed via plasma pharmacokinetics and biochemical analyses, respectively. (ClinicalTrials.gov identifier: NCT01942135) RESULTS: Median PFS for premenopausal women in the palbociclib ( n  = 72) versus placebo arm ( n  = 36) was 9.5 versus 5.6 months, respectively (hazard ratio, 0.50, 95% confidence interval: 0.29-0.87), and consistent with the significant PFS improvement in the same arms for postmenopausal women. Any-grade and grade ≤3 neutropenia, leukopenia, and infections were among the most frequent adverse events reported in the palbociclib arm with concurrent goserelin administration. Hormone concentrations were similar between treatment arms and confirmed sustained ovarian suppression. Clinically relevant DDIs were not observed. Palbociclib combined with fulvestrant and goserelin was an effective and well-tolerated treatment for premenopausal women with prior endocrine-resistant HR+/HER2- ABC. Inclusion of both premenopausal and postmenopausal women in pivotal combination ET trials facilitates access to novel drugs for young women and should be considered as a new standard for clinical trial design. PALOMA-3, the first registrational

  16. Clinical trials of medicinal cannabis for appetite-related symptoms from advanced cancer: a survey of preferences, attitudes and beliefs among patients willing to consider participation.

    Science.gov (United States)

    Luckett, T; Phillips, J; Lintzeris, N; Allsop, D; Lee, J; Solowij, N; Martin, J; Lam, L; Aggarwal, R; McCaffrey, N; Currow, D; Chye, R; Lovell, M; McGregor, I; Agar, M

    2016-11-01

    Australian clinical trials are planned to evaluate medicinal cannabis in a range of clinical contexts. To explore the preferences, attitudes and beliefs of patients eligible and willing to consider participation in a clinical trial of medicinal cannabis for poor appetite and appetite-related symptoms from advanced cancer. A cross-sectional anonymous survey was administered from July to December 2015 online and in eight adult outpatient palliative care and/or cancer services. Respondents were eligible if they were ≥18 years, had advanced cancer and poor appetite/taste problems/weight loss and might consider participating in a medicinal cannabis trial. Survey items focused on medicinal rather than recreational cannabis use and did not specify botanical or pharmaceutical products. Items asked about previous medicinal cannabis use and preferences for delivery route and invited comments and concerns. There were 204 survey respondents, of whom 26 (13%) reported prior medicinal cannabis use. Tablets/capsules were the preferred delivery mode (n = 144, 71%), followed by mouth spray (n = 84, 42%) and vaporiser (n = 83, 41%). Explanations for preferences (n = 134) most commonly cited convenience (n = 66; 49%). A total of 82% (n = 168) of respondents indicated that they had no trial-related concerns, but a small number volunteered concerns about adverse effects (n = 14) or wanted more information/advice (n = 8). Six respondents volunteered a belief that cannabis might cure cancer, while two wanted assurance of efficacy before participating in a trial. Justification of modes other than tablets/capsules and variable understanding about cannabis and trials will need addressing in trial-related information to optimise recruitment and ensure that consent is properly informed. © 2016 Royal Australasian College of Physicians.

  17. Health-related quality-of-life outcomes: a reflexology trial with patients with advanced-stage breast cancer.

    Science.gov (United States)

    Wyatt, Gwen; Sikorskii, Alla; Rahbar, Mohammad Hossein; Victorson, David; You, Mei

    2012-11-01

    To evaluate the safety and efficacy of reflexology, a complementary therapy that applies pressure to specific areas of the feet. Longitudinal, randomized clinical trial. Thirteen community-based medical oncology clinics across the midwestern United States. A convenience sample of 385 predominantly Caucasian women with advanced-stage breast cancer receiving chemotherapy and/or hormonal therapy. Following the baseline interview, women were randomized into three primary groups: reflexology (n = 95), lay foot manipulation (LFM) (n = 95), or conventional care (n = 96). Two preliminary reflexology (n = 51) and LFM (n = 48) test groups were used to establish the protocols. Participants were interviewed again postintervention at study weeks 5 and 11. Breast cancer-specific health-related quality of life (HRQOL), physical functioning, and symptoms. No adverse events were reported. A longitudinal comparison revealed significant improvements in physical functioning for the reflexology group compared to the control group (p = 0.04). Severity of dyspnea was reduced in the reflexology group compared to the control group (p Reflexology may be added to existing evidence-based supportive care to improve HRQOL for patients with advanced-stage breast cancer during chemotherapy and/or hormonal therapy. Reflexology can be recommended for safety and usefulness in relieving dyspnea and enhancing functional status among women with advanced-stage breast cancer.

  18. Limited accessibility to designs and results of Japanese large-scale clinical trials for cardiovascular diseases.

    Science.gov (United States)

    Sawata, Hiroshi; Ueshima, Kenji; Tsutani, Kiichiro

    2011-04-14

    Clinical evidence is important for improving the treatment of patients by health care providers. In the study of cardiovascular diseases, large-scale clinical trials involving thousands of participants are required to evaluate the risks of cardiac events and/or death. The problems encountered in conducting the Japanese Acute Myocardial Infarction Prospective (JAMP) study highlighted the difficulties involved in obtaining the financial and infrastructural resources necessary for conducting large-scale clinical trials. The objectives of the current study were: 1) to clarify the current funding and infrastructural environment surrounding large-scale clinical trials in cardiovascular and metabolic diseases in Japan, and 2) to find ways to improve the environment surrounding clinical trials in Japan more generally. We examined clinical trials examining cardiovascular diseases that evaluated true endpoints and involved 300 or more participants using Pub-Med, Ichushi (by the Japan Medical Abstracts Society, a non-profit organization), websites of related medical societies, the University Hospital Medical Information Network (UMIN) Clinical Trials Registry, and clinicaltrials.gov at three points in time: 30 November, 2004, 25 February, 2007 and 25 July, 2009. We found a total of 152 trials that met our criteria for 'large-scale clinical trials' examining cardiovascular diseases in Japan. Of these, 72.4% were randomized controlled trials (RCTs). Of 152 trials, 9.2% of the trials examined more than 10,000 participants, and 42.8% examined between 1,000 and 10,000 participants. The number of large-scale clinical trials markedly increased from 2001 to 2004, but suddenly decreased in 2007, then began to increase again. Ischemic heart disease (39.5%) was the most common target disease. Most of the larger-scale trials were funded by private organizations such as pharmaceutical companies. The designs and results of 13 trials were not disclosed. To improve the quality of clinical

  19. Treatment outcome of advanced pancreatic cancer patients who are ineligible for a clinical trial

    Directory of Open Access Journals (Sweden)

    Ueda A

    2013-05-01

    Full Text Available Akira Ueda, Ayumu Hosokawa, Kohei Ogawa, Hiroki Yoshita, Takayuki Ando, Shinya Kajiura, Haruka Fujinami, Kengo Kawai, Jun Nishikawa, Kazuto Tajiri, Masami Minemura, Toshiro SugiyamaDepartment of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, JapanObjective: The aim of this study was to evaluate the outcome of patients with advanced pancreatic cancer in clinical practice, and assess whether chemotherapy provided a clinical benefit for patients who did not meet the eligibility criteria of the clinical trial.Methods: We retrospectively analyzed the medical records of 75 patients who received first-line chemotherapy for pancreatic cancer between April 2006 and September 2011. Patients were treated with gemcitabine (GEM alone, S-1 (tegafur, gimeracil, and oteracil potassium alone, or GEM plus S-1. Patients were divided into the clinical trial eligible group (arm eligible or the ineligible group (arm ineligible. We evaluated the efficacy and the safety of the chemotherapy.Results: A total of 23 patients out of 75 (31% belonged to the ineligible group, for the following reasons: 20 patients had poor performance status, eight had massive ascites, one had synchronous malignancy, and one had icterus. The median progression-free survival (PFS was 3.5 months, and the median overall survival (OS was 6.7 months in all patients. In arm eligible, median PFS was 4.5 months, and median OS was 10.5 months. In arm ineligible, median PFS was 1.1 months, and median OS was 2.9 months.Conclusion: The outcome of the patients who did not meet the eligibility criteria was very poor. It is important to select the patients that could benefit from either chemotherapy or optimal supportive care.Keywords: gemcitabine, S-1, clinical practice

  20. Current Molecular Targeted Therapy in Advanced Gastric Cancer: A Comprehensive Review of Therapeutic Mechanism, Clinical Trials, and Practical Application

    Directory of Open Access Journals (Sweden)

    Kaichun Li

    2016-01-01

    Full Text Available Despite the great progress in the treatment of gastric cancer, it is still the third leading cause of cancer death worldwide. Patients often miss the opportunity for a surgical cure, because the cancer has already developed into advanced cancer when identified. Compared to best supportive care, chemotherapy can improve quality of life and prolong survival time, but the overall survival is often short. Due to the molecular study of gastric cancer, new molecular targeted drugs have entered the clinical use. Trastuzumab, an antibody targeting human epidermal growth factor receptor 2 (HER2, can significantly improve survival in advanced gastric cancer patients with HER2 overexpression. Second-line treatment of advanced gastric cancer with ramucirumab, an antibody targeting VEGFR-2, alone or in combination with paclitaxel, has been proved to provide a beneficial effect. The VEGFR-2 tyrosine kinase inhibitor, apatinib, can improve the survival of advanced gastric cancer patients after second-line chemotherapy failure. Unfortunately, none of the EGFR targeting antibodies (cetuximab or panitumumab, VEGF targeting monoclonal antibodies (bevacizumab, mTOR inhibitor (everolimus, or HGF/MET pathway targeting drugs has a significant survival benefit. Many other clinical trials based on molecular markers are underway. This review will summarize targeted therapies for advanced gastric cancer.

  1. Role of 3D animation in periodontal patient education: a randomized controlled trial.

    Science.gov (United States)

    Cleeren, Gertjan; Quirynen, Marc; Ozcelik, Onur; Teughels, Wim

    2014-01-01

    This randomized controlled parallel trial investigates the effect of 3D animation on the increase and recall of knowledge on periodontitis by patients with periodontitis. The effects of a 3D animation (3D animation group) were compared with narration and drawing (control group) for periodontal patient education. A total of 68 periodontitis patients were stratified according to educational level and then randomly allocated to control or 3D animation groups. All patients received: (1) a pre-test (baseline knowledge), (2) a patient education video (3D animation or control video), (3) a post-test (knowledge immediately after looking at the video), and (4) a follow-up test (knowledge recall after 2 weeks). Each test contained 10 multiple-choice questions. There was no significant difference in baseline knowledge. Patients receiving the 3D animations had significantly higher scores for both the post-test and the follow-up test, when compared with patients receiving sketch animations. 3D animations are more effective than real-time drawings for periodontal patient education in terms of knowledge recall. 3D animations may be a powerful tool for assisting in the information process. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. U.S. DOE Roundtable and Workshop on Advanced Steel Technologies: Emerging Global Technologies and R&D Opportunities

    Energy Technology Data Exchange (ETDEWEB)

    Pellegrino, Joan [Energetics, Inc., Columbia, MD (United States); Jamison, Keith [Energetics, Inc., Columbia, MD (United States)

    2015-12-01

    This report is based on the proceedings of the U.S. DOE Roundtable and Workshop on Advanced Steel Technologies Workshop hosted by Oak Ridge National Laboratory (ORNL) in cooperation with the U.S. Department of Energy s (DOE s) Advanced Manufacturing Office (AMO) on held on June 23, 2015. Representatives from industry, government, and academia met at the offices of the National Renewable Energy Laboratory in Washington, DC, to share information on emerging steel technologies, issues impacting technology investment and deployment, gaps in research and development (R&D), and opportunities for greater energy efficiency. The results of the workshop are summarized in this report. They reflect a snapshot of the perspectives and ideas generated by the individuals who attended and not all-inclusive of the steel industry and stakeholder community.

  3. The effects of vitamin D supplementation on maternal and neonatal outcome: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mahdieh Mojibian

    2015-11-01

    Full Text Available Background: Vitamin D supplementation during pregnancy has been supposed to defend against adverse gestational outcomes. Objective: This randomized clinical trial study was conducted to assess the effects of 50,000 IU of vitamin D every two weeks supplementation on the incidence of gestational diabetes (GDM, gestational hypertension, preeclampsia and preterm labor, vitamin D status at term and neonatal outcomes contrasted with pregnant women that received 400 IU vitamin D daily. Materials and Methods: 500 women with gestational age 12-16 weeks and serum 25 hydroxy vitamin D (25 (OH D less than 30 ng/ml randomly categorized in two groups. Group A received 400 IU vitamin D daily and group B 50,000 IU vitamin D every 2 weeks orally until delivery. Maternal and Neonatal outcomes were assessed in two groups. Results: The incidence of GDM in group B was significantly lower than group A (6.7% versus 13.4% and odds ratio (95% Confidence interval was 0.46 (0.24-0.87 (P=0.01. The mean ± SD level of 25 (OH D at the time of delivery in mothers in group B was significantly higher than A (37.9 ± 19.8 versus 27.2 ± 18.8 ng/ml, respectively (P=0.001. There were no differences in the incidence of preeclampsia, gestational hypertension, preterm labor, and low birth weight between two groups. The mean level of 25 (OH D in cord blood of group B was significantly higher than group A (37.9 ± 18 versus 29.7 ± 19ng/ml, respectively. Anthropometric measures between neonates were not significantly different. Conclusion: Our study showed 50,000 IU vitamin D every 2 weeks decreased the incidence of GDM.

  4. Utility of preoperative ferumoxtran-10 MRI to evaluate retroperitoneal lymph node metastasis in advanced cervical cancer: Results of ACRIN 6671/GOG 0233.

    Science.gov (United States)

    Atri, Mostafa; Zhang, Zheng; Marques, Helga; Gorelick, Jeremy; Harisinghani, Mukesh; Sohaib, Aslam; Koh, Dow-Mu; Raman, Steven; Gee, Michael; Choi, Haesun; Landrum, Lisa; Mannel, Robert; Chuang, Linus; Yu, Jian Qin Michael; McCourt, Carolyn Kay; Gold, Michael

    To assess if ferumoxtran-10 (f-10) improves accuracy of MRI to detect lymph node (LN) metastasis in advanced cervical cancer. F-10 MRI component of an IRB approved HIPAA compliant ACRIN/GOG trial was analyzed. Patients underwent f-10 MRI followed by extra-peritoneal or laparoscopic pelvic and abdominal lymphadenectomy. F-10-sensitive sequences were T2* GRE sequences with TE of 12 and 21. Seven independent blinded readers reviewed f-10-insensitive sequences and all sequences in different sessions. Region correlations were performed between pathology and MRI for eight abdomen and pelvis regions. Sensitivity and specificity were calculated at participant level. Reference standard is based on pathology result of surgically removed LNs. Among 43 women enrolled in the trial between September 2007 and November 2009, 33 women (mean age 49 ±11 years old) with advanced cervical cancer (12 IB2, 3 IIA, 15 IIB and 3 IIIB, 29 squamous cell carcinomas, 32 grade 2 or 3) were evaluable. Based on histopathology, LN metastasis was 39% in abdomen and 70% in pelvis. Sensitivity of all sequence review in pelvis, abdomen, and combined were 83%, 60%, and 86%, compared with 78%, 54%, and 80% for f-10 insensitive sequences ( P : 0.24, 0.44 and 0.14, respectively). Mean diameter of the largest positive focus on histopathology was 13.7 mm in abdomen and 18.8 mm in pelvis ( P = 0.018). Specificities of all sequence review in pelvis, abdomen, and combined were 48%, 75%, and 43%, compared with 75%, 83%, and 73% ( P : 0.003, 0.14, 0.002 respectively) for f-10 insensitive sequences. Addition of f-10 increased MRI sensitivity to detect LN metastasis in advanced cervical cancer. Increased sensitivity did not reach statistical significance and was at the expense of lower specificity.

  5. Results of a prospective randomised trial comparing conventional radiotherapy to split course bifractionated radiation therapy in patients with nasopharyngeal carcinoma

    International Nuclear Information System (INIS)

    Daoud, Jamel; Toumi, Nabil; Siala, Wissem; Ghorbel, Abdelmonem; Drira, Mohamed Mokthar; Frikha, Mounir

    2007-01-01

    Background and purpose: Nasopharyngeal carcinoma (NPC) is generally responsive to radiation therapy. However therapeutic results after conventional radiotherapy remain relatively poor especially for patients with locoregional advanced NPC. The aim of this study was to evaluate the impact of a split course bifractionated radiotherapy regimen in a phase III randomised trial. Patients and methods: From January 1997 to September 2003, 154 patients with M0 histologically proven NPC were treated in our institution. They were staged according to the American Joint Committee on Cancer - International Union Against Cancer (AJCC-UICC) 1986 TNM classification. Patients with locally advanced nodal disease (N2-N3) received induction chemotherapy. All patients were randomised to receive either conventional radiotherapy at 2 Gy/fraction/day, 5 days/week to 70 Gy/7 weeks or split course bifractionated radiotherapy at 1.6 Gy/fraction, twice daily, 5 days/week to 70.4 Gy/6 weeks. Response and toxicity were evaluated according to the WHO and RTOG criteria. Results: Patients were well balanced between the two arms. The complete remission rate was 91% in conventional radiotherapy arm and 93% in bifractionated radiotherapy arm (p = 0.3). There was more grade II-III skin fibrosis in experimental arm with a 5 year actuarial probability of 66% vs 52% (p = 0.04). Locoregional and distant relapses occurred in 34% of cases in conventional arm and 38% in experimental arm (p = 0.28). With a median follow-up of 56 months, the 5 year overall survival and the disease free survival rates were, respectively (71% and 61%), in conventional arm and (62% and 60%) in bifractionated arm, the difference being statistically non significant. Comments: The present trial comparing conventional radiotherapy to a split course bifractionated radiation therapy failed to demonstrate significant improvement in locoregional control and survival in experimental arm which was associated with more grade II-III skin

  6. Consent revisited: the impact of return of results on participants' views and expectations about trial participation.

    Science.gov (United States)

    Tarrant, Carolyn; Jackson, Clare; Dixon-Woods, Mary; McNicol, Sarah; Kenyon, Sara; Armstrong, Natalie

    2015-12-01

    Increasingly, the sharing of study results with participants is advocated as an element of good research practice. Yet little is known about how receiving the results of trials may impact on participants' perceptions of their original decision to consent. We explored participants' views of their decision to consent to a clinical trial after they received results showing adverse outcomes in some arms of the trial. Semi-structured interviews were conducted with a purposive sample of 38 women in the UK who participated in a trial of antibiotics in pregnancy. All had received results from a follow-up study that reported increased risk of adverse outcomes for children of participants in some of the trial intervention arms. Data analysis was based on the constant comparative method. Participants' original decisions to consent to the trial had been based on hope of personal benefit and assumptions of safety. On receiving the results, most made sense of their experience in ways that enabled them to remain content with their decision to take part. But for some, the results provoked recognition that their original expectations might have been mistaken or that they had not understood the implications of their decision to participate. These participants experienced guilt, a sense of betrayal by the maternity staff and researchers involved in the trial, and damage to trust. Sharing of study results is not a wholly benign practice, and requires careful development of suitable approaches for further evaluation before widespread adoption. © 2015 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  7. The Advanced Photon Source: Performance and results from early operation

    International Nuclear Information System (INIS)

    Moncton, D.E.

    1997-01-01

    The Advanced Photon Source at Argonne National Laboratory is now providing researchers with extreme-brilliance undulator radiation in the hard x-ray region of the spectrum. All technical facilities and components are operational and have met design specifications. Fourteen research teams, occupying 20 sectors on the APS experiment hall floor, are currently installing beamline instrumentation or actively taking data. An overview is presented for the first operational years of the Advanced Photon Source. Emphasis is on the performance of accelerators and insertion devices, as well as early scientific results and future plans

  8. The effects of fatty fish intake on adolescents' nutritional status and associations with attention performance: results from the FINS-TEENS randomized controlled trial.

    Science.gov (United States)

    Handeland, Katina; Skotheim, Siv; Baste, Valborg; Graff, Ingvild E; Frøyland, Livar; Lie, Øyvind; Kjellevold, Marian; Markhus, Maria W; Stormark, Kjell M; Øyen, Jannike; Dahl, Lisbeth

    2018-02-23

    Adolescence involves changes in dietary habits that may induce imbalances in the intake of different nutrients. Fish is an important dietary source of omega-3 (n-3) long-chain polyunsaturated fatty acids (LCPUFAs), vitamin D, several minerals and high-quality protein. By using secondary outcomes and exploratory analyses, the aims of this paper were to evaluate if nutritional biomarkers (red blood cell fatty acids, serum (s)-25(OH)D, s-ferritin and urinary iodine concentration (UIC)) were altered during a dietary intervention, and if they mediated previously reported changes in attention performance. In addition, to examine the status of the biomarkers and explore associations between dietary pattern, biomarkers and attention performance cross-sectionally at baseline. The Fish Intervention Studies-TEENS (FINS-TEENS) was a three-armed intervention trial, including adolescents from eight secondary schools (n = 415; age: 14-15y) in Bergen, Norway. Participants were individually randomized to receive either fish meals, meat meals or n-3 LCPUFA supplements, three times a week for a total of 12 weeks. Blood and urine samples were collected pre and post intervention and attention performance was assessed with the d2 test of attention. Analyses of covariance (ANCOVA) assessed differences between groups in changes of biomarkers and linear mixed models were applied in analyses of attention performance and biomarkers. The trial is registered in ClinicalTrials.gov (NCT02350322). At baseline, the mean omega-3 index was 5.8 ± 1.3% and deficient status were identified for s-25(OH)D (54%), s-ferritin (10%) and UIC (40%). The intervention resulted in an increase in DHA and the omega-3 index which was larger in the supplement group compared to the fish and meat group (P < 0.01), and in the fish group compared to the meat group (P < 0.01). No differences between the groups were observed for changes in 25(OH)D, s-ferritin or UIC. None of the biomarkers mediated

  9. ACHIEVING AND SUSTAINING STEADY-STATE ADVANCED TOKAMAK CONDITIONS ON DIII-D

    International Nuclear Information System (INIS)

    WADE, MR; MURAKAMI, M; BRENNAN, DP; CASPER, TA; FERRON, JR; GAROFALO, AM; GREENFIELD, CM; HYATT, AW; JAYAKUMAR, R; KINSEY, JE; LAHAYE, RJ; LAO, LL; LAZARUS, EA; LOHR, J; LUCE, TC; PETTY, CC; POLITZER, PA; PRATER, R; STRAIT, EJ; TURNBULL, AD; WATKINS, JG; WEST, WP

    2002-01-01

    Recent experiments on the DIII-D tokamak have demonstrated the feasibility of sustaining advanced tokamak conditions that combine high fusion power density (β > 4%), high bootstrap current fraction (f BS ∼ 65%), and high non-inductive current fractions (f NI ∼ 85%) for several energy confinement times. The duration of such conditions is limited only by resistive relaxation of the current density profile. Modeling studies indicate that the application of off-axis ECCD will be able to maintain a favorable current density profile for several seconds

  10. Achieving and sustaining steady-state advanced tokamak conditions on DIII-D

    International Nuclear Information System (INIS)

    Wade, M.R.; Murakami, M.; Brennan, D.P.

    2003-01-01

    Recent experiments on the DIII-D tokamak have demonstrated the feasibility of sustaining advanced tokamak conditions that combine high fusion power density (β > 4%), high bootstrap current fraction (f BS ∼ 65%), and high non-inductive current fractions (f NI ∼85%) for several energy confinement times. The duration of such conditions is limited only by resistive relaxation of the current density profile. Modeling studies indicate that the application of off-axis ECCD will be able to maintain a favorable current density profile for several seconds. (author)

  11. Effect of vitamin D replacement on indexes of insulin resistance in overweight elderly individuals: a randomized controlled trial.

    Science.gov (United States)

    El-Hajj Fuleihan, Ghada; Baddoura, Rafic; Habib, Robert H; Halaby, Georges; Arabi, Asma; Rahme, Maya; Singh, Ravinder J; Kassem, Moustapha; Mahfoud, Ziyad; Hoteit, Maha; Daher, Rose T; Kassir, Mohamed-Faisal

    2016-08-01

    It is unclear whether and at what dose vitamin D supplementation affects insulin resistance (IR). We sought to investigate whether vitamin D at doses higher than currently recommended decreases indexes of IR in an ambulatory population of overweight elderly subjects. This double-blind, randomized, controlled multicenter trial enrolled 257 elderly overweight individuals aged ≥65 y with baseline 25-hydroxyvitamin D [25(OH)D] concentrations between 10 and 30 ng/mL. All subjects received 1000 mg calcium citrate/d, with vitamin D administered weekly at an equivalent dose of 600 or 3750 IU/d. The homeostasis model assessment (HOMA) of IR index at 1 y was the primary outcome. We also assessed the McAuley index. In total, 222 subjects (55% women) with a mean ± SD age and body mass index (BMI; in kg/m(2)) of 71 ± 4 y and 30 ± 4, respectively, completed the study. Subjects' baseline characteristics, including IR indexes, were similar across groups: 69% had prediabetes, 54% had hypertension (47% were taking antihypertensive medications), and 60% had hyperlipidemia, nearly half of whom were receiving lipid-lowering drugs. At 1 y, mean ± SD serum 25(OH)D increased from 20 ± 7 to 26 ± 7 ng/mL in the low-dose arm (P vitamin D dose, baseline serum 25(OH)D, or change in 25(OH)D. Vitamin D3 at 3750 IU/d did not improve HOMA-IR compared with the Institute of Medicine Recommended Dietary Allowance of 600 IU/d in elderly overweight individuals. This trial was registered at clinicaltrials.gov as NCT01315366. © 2016 American Society for Nutrition.

  12. Hawaiian Electric Advanced Inverter Test Plan - Result Summary

    Energy Technology Data Exchange (ETDEWEB)

    Hoke, Anderson; Nelson, Austin; Prabakar, Kumaraguru; Nagarajan, Adarsh

    2016-10-14

    This presentation is intended to share the results of lab testing of five PV inverters with the Hawaiian Electric Companies and other stakeholders and interested parties. The tests included baseline testing of advanced inverter grid support functions, as well as distribution circuit-level tests to examine the impact of the PV inverters on simulated distribution feeders using power hardware-in-the-loop (PHIL) techniques. hardware-in-the-loop (PHIL) techniques.

  13. A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial)

    International Nuclear Information System (INIS)

    Ogilvie, Gina S; Cook, Darrel A; Mei, Wendy; Stuart, Gavin CE; Franco, Eduardo L; Coldman, Andrew J; Niekerk, Dirk J van; Krajden, Mel; Martin, Ruth E; Ehlen, Thomas G; Ceballos, Kathy; Peacock, Stuart J; Smith, Laurie W; Kan, Lisa

    2010-01-01

    In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm: hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm: hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. International Standard Randomised Controlled Trial Number Register, ISRCTN79347302

  14. Effectiveness of advance care planning with family carers in dementia nursing homes: A paired cluster randomized controlled trial.

    Science.gov (United States)

    Brazil, Kevin; Carter, Gillian; Cardwell, Chris; Clarke, Mike; Hudson, Peter; Froggatt, Katherine; McLaughlin, Dorry; Passmore, Peter; Kernohan, W George

    2018-03-01

    In dementia care, a large number of treatment decisions are made by family carers on behalf of their family member who lacks decisional capacity; advance care planning can support such carers in the decision-making of care goals. However, given the relative importance of advance care planning in dementia care, the prevalence of advance care planning in dementia care is poor. To evaluate the effectiveness of advance care planning with family carers in dementia care homes. Paired cluster randomized controlled trial. The intervention comprised a trained facilitator, family education, family meetings, documentation of advance care planning decisions and intervention orientation for general practitioners and nursing home staff. A total of 24 nursing homes with a dementia nursing category located in Northern Ireland, United Kingdom. Family carers of nursing home residents classified as having dementia and judged as not having decisional capacity to participate in advance care planning discussions. The primary outcome was family carer uncertainty in decision-making about the care of the resident (Decisional Conflict Scale). There was evidence of a reduction in total Decisional Conflict Scale score in the intervention group compared with the usual care group (-10.5, 95% confidence interval: -16.4 to -4.7; p planning was effective in reducing family carer uncertainty in decision-making concerning the care of their family member and improving perceptions of quality of care in nursing homes. Given the global significance of dementia, the implications for clinicians and policy makers include them recognizing the importance of family carer education and improving communication between family carers and formal care providers.

  15. Using regional broccoli trial data to select experimental hybrids for input into advanced yield trials

    Science.gov (United States)

    A large amount of phenotypic trait data are being generated in regional trials that are implemented as part of the Specialty Crop Research Initiative (SCRI) project entitled “Establishing an Eastern Broccoli Industry”. These data are used to identify the best entries in the trials for inclusion in ...

  16. R and D perspectives on the advanced nuclear safety regulation system

    International Nuclear Information System (INIS)

    Lee, Chang Ju; Ahn, Sang Kyu; Park, Jong Seuk; Chung, Dae Wook; Han, Sang Hoon; Lee, Jung Won

    2009-01-01

    As current licensing process is much desired to be optimized both plant safety and regulatory efficiency, an advanced safety regulation such as risk informed regulation has been come out. Also, there is a need to have a future oriented safety regulation since a lot of new reactors are conceptualized. Keeping pace with these needs, since early 2007, Korean government has launched a new project for preparing an advanced and future oriented nuclear safety regulation system. In order to get practical achievements, the project team sets up such specific research objectives for the development of: implementation program for graded regulation using risk and performance information; multi purpose PSA models for regulatory uses; a technology neutral regulatory framework for future innovative reactors; evaluation procedure of proliferation resistance; and, performance based fire hazard analysis method and evaluation system. This paper introduces major R and D outputs of this project, and provides some perspectives for achieving effectiveness and efficiency of the nuclear regulation system in Korea

  17. R and D perspectives on the advanced nuclear safety regulation system

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Chang Ju; Ahn, Sang Kyu; Park, Jong Seuk; Chung, Dae Wook [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of); Han, Sang Hoon; Lee, Jung Won [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2009-04-15

    As current licensing process is much desired to be optimized both plant safety and regulatory efficiency, an advanced safety regulation such as risk informed regulation has been come out. Also, there is a need to have a future oriented safety regulation since a lot of new reactors are conceptualized. Keeping pace with these needs, since early 2007, Korean government has launched a new project for preparing an advanced and future oriented nuclear safety regulation system. In order to get practical achievements, the project team sets up such specific research objectives for the development of: implementation program for graded regulation using risk and performance information; multi purpose PSA models for regulatory uses; a technology neutral regulatory framework for future innovative reactors; evaluation procedure of proliferation resistance; and, performance based fire hazard analysis method and evaluation system. This paper introduces major R and D outputs of this project, and provides some perspectives for achieving effectiveness and efficiency of the nuclear regulation system in Korea.

  18. Report on 1985 research result on the R and D of environmental resistance reinforcing element; 1985 nendo taikankyo kyoka soshi no kenkyu kaihatsu

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-03-01

    This research was intended to establish technology for the substrate of an environmental resistance reinforcing element in which environmental resistance was enhanced against radiation, heat, mechanical shock, etc., for the purpose of realizing various kinds of equipment and devices for performing advanced information processing under severe environmental conditions of outer space, nuclear reactors, travelling objects such as automobiles and aircrafts, and plants. In the R and D of the technology of a MOS type silicon integrated circuit element, a low temperature generalizing process technology was developed, with selection made for SOS and bulk silicon. In addition, strength of a wiring connecting part was examined, as was the heat dissipation of the package. In the R and D of the technology of a bipolar type silicon integrated circuit element, examined were the element design/integration-technology/materials, evaluation and optimization of the processing technology, reproducibility of the factor processing technology, environmentally resistant plastic packages, etc. In the R and D of the technology of a compound semiconductor integrated circuit element, analysis of a gate electrode structure and deteriorating mechanism was made, as was the influence of the element structure parameter on environmental resistance, with an improved trial manufacturing and an environmental test performed for the actually mounted bodies. (NEDO)

  19. Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3.

    Science.gov (United States)

    Takács, István; Tóth, Béla E; Szekeres, László; Szabó, Boglárka; Bakos, Bence; Lakatos, Péter

    2017-01-01

    The comparative efficacy and safety profiles of selected daily 1000 IU, weekly 7000 IU and monthly 30,000 IU vitamin D 3 -not previously investigated-will be evaluated. Here, a prospective, randomized clinical trial, comparing efficacy and safety of a daily single dose of 1000 IU (group A) to a once-weekly 7000 IU dose (group B), or monthly 30,000 IU dose (group C) of vitamin D 3 . The present study is a controlled, randomized, open-label, multicenter clinical trial, 3  months in duration. Sixty-four adult subjects with vitamin D deficiency (25OHD<20 ng/ml), were included according to the inclusion and exclusion criteria. Dose-responses for increases in serum vitamin 25OHD were statistically equivalent for each of the three groups: A, B and C. Outcomes were 13.0 ± 1.5; 12.6 ± 1.1 and 12.9 ± 0.9 ng/ml increases in serum 25OHD per 1000 IU, daily, weekly and monthly, respectively. The treatment of subjects with selected doses restored 25OHD values to levels above 20 ng/ml in all groups. Treatment with distinct administration frequency of vitamin D 3 did not exhibit any differences in safety parameters. The daily, weekly and monthly administrations of daily equivalent of 1000 IU of vitamin D 3 provide equal efficacy and safety profiles.

  20. Advances in the operation of the DIII-D neutral beam computer systems

    International Nuclear Information System (INIS)

    Phillips, J.C.; Busath, J.L.; Penaflor, B.G.; Piglowski, D.; Kellman, D.H.; Chiu, H.K.; Hong, R.M.

    1998-02-01

    The DIII-D neutral beam system routinely provides up to 20 MW of deuterium neutral beam heating in support of experiments on the DIII-D tokamak, and is a critical part of the DIII-D physics experimental program. The four computer systems previously used to control neutral beam operation and data acquisition were designed and implemented in the late 1970's and used on DIII and DIII-D from 1981--1996. By comparison to modern standards, they had become expensive to maintain, slow and cumbersome, making it difficult to implement improvements. Most critical of all, they were not networked computers. During the 1997 experimental campaign, these systems were replaced with new Unix compliant hardware and, for the most part, commercially available software. This paper describes operational experience with the new neutral beam computer systems, and new advances made possible by using features not previously available. These include retention and access to historical data, an asynchronously fired ''rules'' base, and a relatively straightforward programming interface. Methods and principles for extending the availability of data beyond the scope of the operator consoles will be discussed

  1. Individualised 3D printed vaginal template for MRI guided brachytherapy in locally advanced cervical cancer

    DEFF Research Database (Denmark)

    Lindegaard, Jacob Christian; Lænsø Madsen, Mads; Hansen, Anders Traberg

    2016-01-01

    Intracavitary–interstitial applicators for MRI guided brachytherapy are becoming increasingly important in locally advanced cervical cancer. The 3D printing technology enables a versatile method for obtaining a high degree of individualisation of the implant. Our clinical workflow is presented...

  2. Evolution of Serum 25OHD in Response to Vitamin D3–Fortified Yogurts Consumed by Healthy Menopausal Women: A 6-Month Randomized Controlled Trial Assessing the Interactions between Doses, Baseline Vitamin D Status, and Seasonality

    Science.gov (United States)

    Bonjour, Jean-Philippe; Dontot-Payen, Flore; Rouy, Emilien; Walrand, Stephane; Rousseau, Brigitte

    2018-01-01

    ABSTRACT Background: Adequate vitamin D status contributes to bone fragility risk reduction and possibly other pathological conditions that occur with aging. In response to pharmaceutical vitamin D3 supplements, several studies have documented the influence of doses, baseline status, and seasonality on serum 25-hydroyvitamin D (s25OHD). Objective: Using fortified yogurt, we investigated in one randomized controlled trial how both baseline status, as assessed by measuring s25OHD prior the onset of the trial, and the season of enrollment quantitatively influenced the response to the supplemented (Suppl.) of vitamin D3 (VitD3) in healthy community-dwelling women. Methods: A 24-week controlled trial was conducted in menopausal women (mean age: 61.5). Participants were randomized into 3 groups (Gr): Gr.Suppl.0, time controls maintaining dietary habits; Gr.Suppl.5 and Gr.Suppl.10 consuming one and two 125-g servings of VitD3-fortified yogurts with 5- and 10-µg daily doses, respectively. The 16 intervention weeks lasted from early January to mid-August, the 8 follow-up weeks, without product, from late August to mid-October. Before enrollment, subjects were randomized into 2 s25OHD strata: low stratum (LoStr): 25–50 nmol/L; high stratum (HiStr): >50–75 nmol/L. Results: All enrolled participants adhered to the protocol throughout the 24-week study: Gr.Suppl.0 (n = 45), Gr.Suppl.5 (n = 44), and Gr.Suppl.10 (n = 44). Over the 16 intervention and 8 follow-up weeks, s25OHD increased in both supplemented groups, more in Gr.Suppl.10 than in Gr.Suppl.5. At the end of the intervention, the subject proportion with s25OHD ≥ 50 nmol/L was 37.8, 54.5, and 63.6% in Gr.Suppl.0, Gr.Suppl.5, and Gr.Suppl.10, respectively. The constant rate of s25OHD per supplemental VitD3 microgram was greater in LoStr than HiStr. The s25OHD increase was greater with late (mid-March) than early (mid-January) inclusion. Conclusion: This randomized trial demonstrates (1) a dose-dependent s25OHD

  3. Advanced 3-D Ultrasound Imaging

    DEFF Research Database (Denmark)

    Rasmussen, Morten Fischer

    The main purpose of the PhD project was to develop methods that increase the 3-D ultrasound imaging quality available for the medical personnel in the clinic. Acquiring a 3-D volume gives the medical doctor the freedom to investigate the measured anatomy in any slice desirable after the scan has...... been completed. This allows for precise measurements of organs dimensions and makes the scan more operator independent. Real-time 3-D ultrasound imaging is still not as widespread in use in the clinics as 2-D imaging. A limiting factor has traditionally been the low image quality achievable using...... a channel limited 2-D transducer array and the conventional 3-D beamforming technique, Parallel Beamforming. The first part of the scientific contributions demonstrate that 3-D synthetic aperture imaging achieves a better image quality than the Parallel Beamforming technique. Data were obtained using both...

  4. Hyperfractionated conformal radiotherapy in locally advanced prostate cancer: results of a dose escalation study

    International Nuclear Information System (INIS)

    Forman, Jeffrey D.; Duclos, Marie; Shamsa, Falah; Porter, Arthur T.; Orton, Colin

    1996-01-01

    Purpose: This study was initiated to assess the incidence of chronic complications and histologic and biochemical control following hyperfractionated conformal radiotherapy in patients with locally advanced prostate cancer. Methods and Materials: Between October 1991 and October 1994, 49 patients with locally advanced prostate cancer were entered on the first two dose levels of a prospective dose-escalation study using hyperfractionated three dimensional conformal radiotherapy. The first 25 patients received a minimum tumor dose of 78 Gy to the prostate and seminal vesicles in 6 weeks at 1.3 Gy, b.i.d. No increase in chronic toxicity compared with conventional radiotherapy was noted; therefore, an additional 24 patients were treated to a minimum tumor dose of 82.8 Gy to the prostate and seminal vesicles in 7 weeks at 1.15 Gy, b.i.d. Toxicity was scored according to the Radiation Therapy Oncology Group morbidity grading scale. Efficacy was assessed through scheduled postradiation prostate specific antigen values and ultrasound-guided biopsies. The median follow-up for the entire group was 20 months. Results: The hyperfractionated external radiation was well tolerated with minimal acute morbidity. At 30 months, the actuarial probability of Grade 2 gastrointestinal toxicity was 17%. At 30 months, the actuarial probability of Grade 2 genitourinary toxicity was 16%. There was no statistically significant difference between the two dose levels. No Grade 3 or 4 gastrointestinal or genitourinary toxicity was noted. At 12 months, 84% of patients had a prostate specific antigen ≤ 4; and 53%; ≤ 1 ng/ml. At 12 months, 71% of patients had post radiation biopsies that were either negative (55%) or showed a marked therapeutic effect (16%). Conclusion: The use of hyperfractionated conformal radiotherapy facilitated dose escalation with no increase in chronic toxicity compared to standard doses. The initial tumor response based on prostate specific antigen measurements and

  5. Prospective trial of aggressive postoperative bowel stimulation following radical hysterectomy.

    Science.gov (United States)

    Fanning, J; Yu-Brekke, S

    1999-06-01

    Postoperative traditional feeding protocols are not based on scientific studies, but rather on anecdotal evidence. We present the first prospective trial of aggressive postoperative bowel stimulation following radical hysterectomy in an attempt to determine its effect on the length of hospital stay. Twenty consecutive patients undergoing radical hysterectomy were entered onto a prospective trial of aggressive postoperative bowel stimulation, which consisted of 30 cc milk of magnesia p.o. b.i.d. starting on postoperative day 1 and biscolic suppositories q.d. starting on day 2. A clear liquid diet was begun following flatus or bowel movement and patients were discharged 12 h after tolerating a clear liquid diet. Diet was slowly advanced at home. Median time to flatus was 3 days, bowel movement 3 days, and clear liquid diet 3 days. Median time to discharge was 4 days. No patients developed ileus or bowel obstructions and there were no readmissions for bowel complications. Our median time to discharge of 4 days represents a 50% reduction in hospital stay compared to our previous prospective study using traditional postoperative bowel management (8 days), which was statistically significant at P = 0.001. Aggressive bowel stimulation with milk of magnesia and biscolic suppositories resulted in early return of bowel function and early discharge with no noticeable complications. Copyright 1999 Academic Press.

  6. Money and morals: ending clinical trials for financial reasons.

    Science.gov (United States)

    Eaton, Margaret L; Kwon, Brian K; Scott, Christopher Thomas

    2015-01-01

    Too often, biopharmaceutical companies stop their clinical trials solely for financial reasons. In this chapter, we discuss this phenomenon against the backdrop of a 2011 decision by Geron Corporation to abandon its stem cell clinical trial for spinal cord injury (SCI), the preliminary results of which were released in May 2014. We argue that the resultant harms are widespread and are different in nature from the consequences of stopping trials for scientific or medical reasons. We examine the ethical and social effects that arise from such decisions and discuss them in light of ethical frameworks, including duties of individual stakeholders and corporate sponsors. We offer ways that sponsors and clinical sites can ensure that trials are responsibly started, and once started adequately protect the interests of participants. We conclude with recommendations that industry sponsors of clinical trials should adopt in order to advance a collective and patient-centered research ethic.

  7. SPIRIT advance care planning intervention in early stage dementias: An NIH stage I behavioral intervention development trial.

    Science.gov (United States)

    Song, Mi-Kyung; Ward, Sandra E; Hepburn, Kenneth; Paul, Sudeshna; Shah, Raj C; Morhardt, Darby J

    2018-06-02

    People in the early stages of Alzheimer's disease and related dementias (ADRD) are encouraged to engage in advance care planning (ACP) while they are still competent to appoint a surrogate decision maker and meaningfully participate in ACP discussions with the surrogate. In this NIH Stage I behavioral intervention development trial, we will adapt and test an efficacious ACP intervention, SPIRIT (Sharing Patient's Illness Representation to Increase Trust), with people with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible. We will first adapt SPIRIT (in person) to target people with mild dementia and their surrogates through a process of modification-pretesting-refinement using stakeholders (persons with mild dementia, family caregivers, and clinicians) and experts, including adapting the delivery mode to interactive web-based videoconference format (SPIRIT-remote). Then in a 3-group RCT with 120 patient-surrogate dyads, we will evaluate the feasibility and acceptability of SPIRIT in-person and SPIRIT remote, and preliminary efficacy of SPIRIT compared to usual care on preparedness outcomes for end-of-life decision making (dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence) shortly after the intervention. This Stage I research of SPIRIT will generate valuable insights regarding how to improve ACP for people with mild dementia who will progress to an advanced stage of the disease in the foreseeable future. ClinicalTrials.gov NCT03311711, Registered 10/12/2017. Copyright © 2018. Published by Elsevier Inc.

  8. The IROC Houston Quality Assurance Program: Potential benefits of 3D dosimetry

    International Nuclear Information System (INIS)

    Followill, D S; Molineu, H A; Lafratta, R; Ibbott, G S

    2017-01-01

    The IROC Houston QA Center has provided QA core support for NCI clinical trials by ensuring that radiation doses delivered to trial patients are accurate and comparable between participating institutions. Within its QA program, IROC Houston uses anthropomorphic QA phantoms to credential sites. It is these phantoms that have the highest potential to benefit from the use of 3D dosimeters. Credentialing is performed to verify that institutions that are using advanced technologies to deliver complex treatment plans that conform to targets. This makes it increasingly difficult to assure the intended calculated dose is being delivered correctly using current techniques that are 2D-based. A 3D dosimeter such as PRESAGE® is able to provide a complete 3D measured dosimetry dataset with one treatment plan delivery. In our preliminary studies, the 3D dosimeters in our H and N and spine phantoms were found to be appropriate for remote dosimetry for relative dose measurements. To implement 3D dosimetry in IROC Houston’s phantoms, the benefit of this significant change to its current infrastructure would have to be assess