WorldWideScience

Sample records for advance-d trial results

  1. National Lung Screening Trial Results: Fast Facts

    Science.gov (United States)

    On November 4, 2010, the NLST reported initial trial results, showing 20 percent fewer lung cancer deaths among trial participants screened with low-dose helical CT (also known as spiral CT) compared to those who got screened with chest X-rays.

  2. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study

    OpenAIRE

    Prayle, A.P.; Hurley, M.N.; Smyth, Alan R

    2012-01-01

    Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation. Design Registry based study of clinical trial summaries. Data sources ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one...

  3. Implications of HIV PrEP Trials Results

    OpenAIRE

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

    2011-01-01

    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 H...

  4. Evaluation of the PISC trials results

    International Nuclear Information System (INIS)

    This report gives the results of the analysis carried out in the manner described in PISC report no.4, to compare the defects indicated by ultrasonic examination with those discovered by a destructive examination. The analysis was repeated three times; once for ultrasonic examination using the PISC procedure but with as much as possible subjective interpretation from the teams removed, once for ultrasonic examination using the PISC procedure incorporating the subjective interpretation of the teams, and once for ultrasonic examination using a variety of alternative techniques. Results are given in the form of tables and figures for each reference defect (i.e. those found by the destructive examination) in turn. Correlations, when they exist, are presented between the parameters describing the performance of the ultrasonic examination procedures and the parameters describing the reference defects. From the global set of results conclusions are drawn concerning the efficiency of the ultrasonic procedures for detecting, sizing, locating and correct rejection of defects

  5. Clinical Trials Registration and Results Information Submission. Final rule.

    Science.gov (United States)

    2016-09-21

    This final rule details the requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drug products (including biological products) and device products and for pediatric postmarket surveillances of a device product to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM) of the National Institutes of Health (NIH). This rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to help patients find trials for which they might be eligible, enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, improve the evidence base that informs clinical care, increase the efficiency of drug and device development processes, improve clinical research practice, and build public trust in clinical research. The requirements apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drug products (including biological products) and device products that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device product that are ordered by FDA. PMID:27658315

  6. Are clinical trial results transferable in the real life?

    Science.gov (United States)

    Natale, Enrico; Marsocci, Alfiera

    2016-06-22

    Generally in the clinical practice patients are more complex in comparison with those included in the clinical trials. In this article, we discuss three relevant items, which may implement the transferability of the clinical trial results in the real world. The observational studies have fewer restrictions on the number of patients included, due to more relaxed inclusion and exlusion criteria than in randomized clinical trials. The absence of randomization however may lead to potential for bias. The recurrent event analysis may extend the positive results of clinical trials regarding the reductions of the first primary endpoint event to total events, including those beyond the first event. This analysis is of great interest in the clinical practice, where recurrent events are common. Finally the reliability of subgroup analysis is discussed. Pre-specified subgroup analyses are more credible and valuable than post-hoc analyses.

  7. Clinical Trial Results Vary Widely, But Always Advance Research | NIH MedlinePlus the Magazine

    Science.gov (United States)

    ... of this page please turn Javascript on. Feature: Clinical Trials Clinical Trial Results Vary Widely, But Always Advance Research Past ... very emotional." Should You Be Interested in a Clinical Trial People volunteer to take part in clinical trials ...

  8. Multi-optical mine detection: results from a field trial

    Science.gov (United States)

    Letalick, Dietmar; Tolt, Gustav; Sjökvist, Stefan K.; Nyberg, Sten; Grönwall, Christina; Andersson, Pierre; Linderhed, Anna; Forssell, Göran; Larsson, Håkan; Uppsäll, Magnus

    2006-05-01

    As a part of the Swedish mine detection project MOMS, an initial field trial was conducted at the Swedish EOD and Demining Centre (SWEDEC). The purpose was to collect data on surface-laid mines, UXO, submunitions, IED's, and background with a variety of optical sensors, for further use in the project. Three terrain types were covered: forest, gravel road, and an area which had recovered after total removal of all vegetation some years before. The sensors used in the field trial included UV, VIS, and NIR sensors as well as thermal, multi-spectral, and hyper-spectral sensors, 3-D laser radar and polarization sensors. Some of the sensors were mounted on an aerial work platform, while others were placed on tripods on the ground. This paper describes the field trial and the presents some initial results obtained from the subsequent analysis.

  9. Implications of the results of community intervention trials.

    Science.gov (United States)

    Sorensen, G; Emmons, K; Hunt, M K; Johnston, D

    1998-01-01

    This paper examines the results of population-level interventions conducted in three settings: entire communities, worksites, and schools. Four major conclusions are discussed: (a) Directions for the next generation of community-based interventions include targeting multiple levels of influence; addressing social inequalities in disease risk; involving communities in program planning and implementation; incorporating approaches for "tailoring" interventions; and utilizing rigorous process evaluation. (b) In addition to randomized controlled trials, it is time to use the full range of research phases available, from hypothesis generation and methods development to dissemination research. (c) The public health research agenda may have contributed to observed secular trends by placing behavioral risk factors on the social and media agendas. (d) The magnitude of the results of community intervention trials must be judged according to their potential public health or population-level effects. Small changes at the individual level may result in large benefits at the population level. PMID:9611625

  10. What CATIE Found: Results From the Schizophrenia Trial

    Science.gov (United States)

    Swartz, Marvin S.; Stroup, T. Scott; McEvoy, Joseph P.; Davis, Sonia M.; Rosenheck, Robert A.; Keefe, Richard S. E.; Hsiao, John K.; Lieberman, Jeffrey A.

    2016-01-01

    The authors provide an overview of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) sponsored by the National Institute of Mental Health. CATIE was designed to compare a proxy first-generation antipsychotic, perphenazine, to several newer drugs. In phase 1 of the trial, consenting patients were randomly assigned to receive olanzapine, perphenazine, quetiapine, risperidone, or ziprasidone for up to 18 months on a double-blind basis. Patients with tardive dyskinesia were excluded from being randomly assigned to perphenazine and were assigned to one of the four second-generation antipsychotics in phase 1A. Clozapine was included in phase 2 of the study. Overall, olanzapine had the longest time to discontinuation in phase 1, but it was associated with significant weight and metabolic concerns. Perphenazine was not significantly different in overall effectiveness, compared with quetiapine, risperidone, and ziprasidone. Also, perphenazine was found to be the most cost-effective drug. Clozapine was confirmed as the most effective drug for individuals with a poor symptom response to previous antipsychotic drug trials, although clozapine was also associated with troublesome adverse effects. There were no differences in neurocognitive or psychosocial functioning in response to medications. Subsequent randomizations suggest that a poor response to an initial medication may mean that a different medication will be more effective or better tolerated. Although the CATIE results are controversial, they are broadly consistent with most previous antipsychotic drug trials and meta-analyses; however, the results may not generalize well to patients at high risk of tardive dyskinesia. Patient characteristics and clinical circumstances affected drug effectiveness; these patient factors are important in making treatment choices. PMID:18451005

  11. -ctgov-: A suite of Stata commands for reporting trial results to ClinicalTrials.gov

    OpenAIRE

    Phil Schumm; Theodore Karrison

    2014-01-01

    In response to the 1997 Food and Drug Administration Modernization Act (FDAMA), the National Institutes of Health (NIH) established ClinicalTrials.gov, an online, publicly-accessible registry for clinical trials. The 2007 Food and Drug Administration Amendments Act (FDAAA) broadened the scope of eligible trials, added outcomes reporting as a requirement, and established penalties for non-compliance. Although ClinicalTrials.gov increased the transparency with which clinical trials are conducte...

  12. Improving Osteoporosis Screening: Results from a Randomized Cluster Trial

    Science.gov (United States)

    Kolk, Deneil; Peterson, Edward L.; McCarthy, Bruce D.; Weiss, Thomas W.; Chen, Ya-Ting; Muma, Bruce K.

    2007-01-01

    Background Despite recommendations, osteoporosis screening rates among women aged 65 years and older remain low. We present results from a clustered, randomized trial evaluating patient mailed reminders, alone and in combination with physician prompts, to improve osteoporosis screening and treatment. Methods Primary care clinics (n = 15) were randomized to usual care, mailed reminders alone, or mailed reminders with physician prompts. Study patients were females aged 65–89 years (N = 10,354). Using automated clinical and pharmacy data, information was collected on bone mineral density testing, pharmacy dispensings, and other patient characteristics. Unadjusted/adjusted differences in testing and treatment were assessed using generalized estimating equation approaches. Results Osteoporosis screening rates were 10.8% in usual care, 24.1% in mailed reminder, and 28.9% in mailed reminder with physician prompt. Results adjusted for differences at baseline indicated that mailed reminders significantly improved testing rates compared to usual care, and that the addition of prompts further improved testing. This effect increased with patient age. Treatment rates were 5.2% in usual care, 8.4% in mailed reminders, and 9.1% in mailed reminders with prompt. No significant differences were found in treatment rates between those receiving mailed reminders alone or in combination with physician prompts. However, women receiving usual care were significantly less likely to be treated. Conclusions The use of mailed reminders, either alone or with physician prompts, can significantly improve osteoporosis screening and treatment rates among insured primary care patients (Clinical Trials.gov number NCT00139425). PMID:17356966

  13. Dispersant trial at ANO-2: Results from a short-term trial prior to SG replacement

    Energy Technology Data Exchange (ETDEWEB)

    Fruzzetti, K.; Frattini, P. [Electric Power Research Inst., Palo Alto, CA (United States); Robbins, P. [Entergy Operations, Arkansas Nuclear One, Russellville, AR (United States); Miller, A. [Pedro Point Technology, Inc., Pacifica, CA (United States); Varrin, R.; Kreider, M. [Dominion Engineering Inc., McLean, VA (United States)

    2002-07-01

    Corrosion products in the secondary side of pressurized water reactor (PWR) steam generators (SGs) primarily deposit on the SG tubes. These deposits can inhibit heat transfer, lead to thermal-hydraulic instabilities through blockage of tube supports, and create occluded regions where corrosive species can concentrate along tubes and in tube-to-tube support plate crevices. The performance of the SGs is compromised not only by formation of an insulating scale, but by the removal of tubes from service due to corrosion. A potential strategy for minimizing deposition of corrosion products on SG internal surfaces is to use an online dispersant to help prevent the corrosion products from adhering to the steam generator surfaces. By inhibiting the deposition of the corrosion products, the dispersant can facilitate more effective removal from the SGs via blowdown. This type of strategy has been employed at fossil boilers for many decades. However, due to the use of inorganic (sulfur and other impurities) polymerization initiators, polymeric dispersants had not been utilized in the nuclear industry. Only recently has a poly-acrylic acid dispersant, developed by BetzDearborn (PAA), been available that meets the criteria for nuclear application. This paper summarizes the results of the short-term PAA dispersant trial in Winter/Spring 2000, lasting approximately 3 months, performed at Arkansas nuclear one unit 2 (ANO-2)-including the chronology of the trial, the increase in blowdown iron removal efficiency with use of the dispersant, and observed effects on SG performance. (authors)

  14. Cardiometabolic results from an armband-based weight loss trial

    Directory of Open Access Journals (Sweden)

    Sieverdes JC

    2011-05-01

    Full Text Available John C Sieverdes, Xuemei Sui, Gregory A Hand, Vaughn W Barry, Sara Wilcox, Rebecca A Meriwether, James W Hardin, Amanda C McClain, Steven N BlairDepartment of Exercise Science, University of South Carolina, Columbia, SC, USAPurpose: This report examines the blood chemistry and blood pressure (BP results from the Lifestyle Education for Activity and Nutrition (LEAN study, a randomized weight loss trial. A primary purpose of the study was to evaluate the effects of real-time self-monitoring of energy balance (using the SenseWearTM Armband, BodyMedia, Inc Pittsburgh, PA on these health factors.Methods: 164 sedentary overweight or obese adults (46.8 ± 10.8 years; BMI 33.3 ± 5.2 kg/m2; 80% women took part in the 9-month study. Participants were randomized into 4 conditions: a standard care condition with an evidence-based weight loss manual (n = 40, a group-based behavioral weight loss program (n = 44, an armband alone condition (n = 41, and a group plus armband (n = 39 condition. BP, fasting blood lipids and glucose were measured at baseline and 9 months.Results: 99 participants (60% completed both baseline and follow-up measurements for BP and blood chemistry analysis. Missing data were handled by baseline carried forward. None of the intervention groups had significant changes in blood lipids or BP when compared to standard care after adjustment for covariates, though within-group lowering was found for systolic BP in group and group + armband conditions, a rise in total cholesterol and LDL were found in standard care and group conditions, and a lowering of triglycerides was found in the two armband conditions. Compared with the standard care condition, fasting glucose decreased significantly for participants in the group, armband, and group + armband conditions (all P < 0.05, respectively.Conclusion: Our results suggest that using an armband program is an effective strategy to decrease fasting blood glucose. This indicates that devices, such as

  15. Premium performance heating oil - Part 2, Field trial results

    Energy Technology Data Exchange (ETDEWEB)

    Jetter, S.M.; Hoskin, D.; McClintock, W.R. [Mobil Oil Corp., Paulsboro, NJ (United States)] [and others

    1996-07-01

    Limited field trial results of a heating oil additive package developed to minimize unscheduled maintenance indicate that it achieves its goal of keeping heating oil systems cleaner. The multifunctional additive package was developed to provide improved fuel oxidation stability, improved corrosion protection, and dispersency. This combination of performance benefits was chosen because we believed it would retard the formation of sludge, as well as allow sludge already present to be carried through the system without fouling the fuel system components (dispersency should keep sludge particles small so they pass through the filtering system). Since many unscheduled maintenance calls are linked to fouling of the fuel filtering system, the overall goal of this technology is to reduce these maintenance calls. Photographic evidence shows that the additive package not only reduces the amount of sludge formed, but even removes existing sludge from filters and pump strainers. This {open_quotes}clean-up{close_quotes} performance is provided trouble free: we found no indication that nozzle/burner performance was impaired by dispersing sludge from filters and pump strainers. Qualitative assessments from specific accounts that used the premium heating oil also show marked reductions in unscheduled maintenance.

  16. Tooth-surface-specific Effects of Xylitol: Randomized Trial Results

    OpenAIRE

    Ritter, A.V.; Bader, J.D.; Leo, M. C.; Preisser, J.S.; Shugars, D.A.; Vollmer, W.M.; Amaechi, B.T.; Holland, J.C.

    2013-01-01

    The Xylitol for Adult Caries Trial was a three-year, double-blind, multi-center, randomized clinical trial that evaluated the effectiveness of xylitol vs. placebo lozenges in the prevention of dental caries in caries-active adults. The purpose of this secondary analysis was to investigate whether xylitol lozenges had a differential effect on cumulative caries increments on different tooth surfaces. Participants (ages 21-80 yrs) with at least one follow-up visit (n = 620) were examined at base...

  17. BRAVISSIMO: 12-month results from a large scale prospective trial.

    Science.gov (United States)

    Bosiers, M; Deloose, K; Callaert, J; Maene, L; Beelen, R; Keirse, K; Verbist, J; Peeters, P; Schroë, H; Lauwers, G; Lansink, W; Vanslembroeck, K; D'archambeau, O; Hendriks, J; Lauwers, P; Vermassen, F; Randon, C; Van Herzeele, I; De Ryck, F; De Letter, J; Lanckneus, M; Van Betsbrugge, M; Thomas, B; Deleersnijder, R; Vandekerkhof, J; Baeyens, I; Berghmans, T; Buttiens, J; Van Den Brande, P; Debing, E; Rabbia, C; Ruffino, A; Tealdi, D; Nano, G; Stegher, S; Gasparini, D; Piccoli, G; Coppi, G; Silingardi, R; Cataldi, V; Paroni, G; Palazzo, V; Stella, A; Gargiulo, M; Muccini, N; Nessi, F; Ferrero, E; Pratesi, C; Fargion, A; Chiesa, R; Marone, E; Bertoglio, L; Cremonesi, A; Dozza, L; Galzerano, G; De Donato, G; Setacci, C

    2013-04-01

    The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery. PMID:23558659

  18. The chronic kidney disease Water Intake Trial (WIT): results from the pilot randomised controlled trial

    Science.gov (United States)

    Clark, William F; Sontrop, Jessica M; Huang, Shih-Han; Gallo, Kerri; Moist, Louise; House, Andrew A; Weir, Matthew A; Garg, Amit X

    2013-01-01

    Background and objectives Increased water intake may benefit kidney function. Prior to initiating a larger randomised controlled trial (RCT), we examined the safety and feasibility of asking adults with chronic kidney disease (CKD) to increase their water intake. Design, setting, participants and measurements Beginning in October 2012, we randomly assigned 29 adults with stage 3 CKD (estimated glomerular filtration rate (eGFR) 30–60 mL/min/1.73 m2 and albuminuria) to one of the two groups of water intake: hydration (n=18) or standard (n=11). We asked the hydration group to increase their water intake by 1.0–1.5 L/day (in addition to usual intake, depending on sex and weight) for 6 weeks, while the control group carried on with their usual intake. Participants collected a 24 h urine sample at baseline and at 2 and 6 weeks after randomisation. Our primary outcome was the between-group difference in change in 24 h urine volume from baseline to 6 weeks. Results (63%)of participants were men, 81% were Caucasians and the average age was 61 years (SD 14 years). The average baseline eGFR was 40 mL/min/1.73 m2 (SD 11 mL/min/1.73 m2); the median albumin to creatinine ratio was 19 mg/mmol (IQR 6–74 mg/mmol). Between baseline and 6-week follow-up, the hydration group's average 24 h urine volume increased by 0.7 L/day (from 2.3 to 3.0 L/day) and the control group's 24 h urine decreased by 0.3 L/day (from 2.0 to 1.7 L/day; between-group difference in change: 0.9 L/day (95% CI 0.4 to 1.5; p=0.002)). We found no significant changes in urine, serum osmolality or electrolyte concentrations, or eGFR. No serious adverse events or changes in quality of life were reported. Conclusions A pilot RCT indicates adults with stage 3 CKD can successfully and safely increase water intake by up to 0.7 L/day in addition to usual fluid intake. Trial registration Registered with Clinical Trials—government identifier NCT01753466. PMID:24362012

  19. Some Results on Two-stage Clinical Trials

    Institute of Scientific and Technical Information of China (English)

    Yu-ming Chen; Gui-jing Chen; Zhi-dong Bai; Fei-fang Hu

    2003-01-01

    Among a variety of adaptive designs, stage-wise design, especially, two-stage design is an important one because patient responses are not available immediately but are available in batches or intermittently in some situations. In this paper, by Bayesian method, the general formula of asymptotical optimal worth is given,meanwhile the length of some optimal designs at first stage concerning two-stage trials in several important cases has been obtained.

  20. Bias from industry trial funding? A framework, a suggested approach, and a negative result.

    Science.gov (United States)

    Barden, Jodie; Derry, Sheena; McQuay, Henry J; Moore, R Andrew

    2006-04-01

    Bias from funding sources of trials would threaten their validity. Meta-analyses of high quality acute pain and migraine trials were used to explore the hypothesis that industry funding of clinical trials produced more favourable results than non-profit sponsorship. Analyses were planned to evaluate whether industry-sponsored trials had different results from trials funded by academic or other non-profit sources, but of 176 trials, only two were supported by non-profit sources, while 31 provided no statement of support. An alternative method is proposed within industry-sponsored trials, looking at conflicting industry interests for the same drug, used either as test or comparator treatment. Fifty-three trials used an analgesic as test and 90 as comparator, allowing comparisons to be made for aspirin 600/650 mg, ibuprofen 400 mg, paracetamol (acetaminophen) 1000 mg, rofecoxib 50 mg and sumatriptan 50 and 100 mg. Only for sumatriptan 50 and 100 mg, with the outcome of headache response at 2 h, was there any significant difference between the drug used as a test or as a comparator. The direction was for higher (worse) NNTs with sumatriptan as comparator. Investigating potential industry bias through the funding source of trials is unlikely to be adequate because of a dearth of trials funded by non-profit organisations. We propose a method based on potential conflict of interest within industry-sponsored trials. Using this method, established clinical trial results in acute pain and migraine appear to be unbiased. PMID:16495012

  1. Results and outcome reporting In ClinicalTrials.gov, what makes it happen?

    Directory of Open Access Journals (Sweden)

    Olga Kirillova

    Full Text Available BACKGROUND: At the end of the past century there were multiple concerns regarding lack of transparency in the conduct of clinical trials as well as some ethical and scientific issues affecting the trials' design and reporting. In 2000 ClinicalTrials.gov data repository was developed and deployed to serve public and scientific communities with valid data on clinical trials. Later in order to increase deposited data completeness and transparency of medical research a set of restrains had been imposed making the results deposition compulsory for multiple cases. METHODS: We investigated efficiency of the results deposition and outcome reporting as well as what factors make positive impact on providing information of interest and what makes it more difficult, whether efficiency depends on what kind of institution was a trial sponsor. Data from the ClinicalTrials.gov repository has been classified based on what kind of institution a trial sponsor was. The odds ratio was calculated for results and outcome reporting by different sponsors' class. RESULTS: As of 01/01/2012 118,602 clinical trials data deposits were made to the depository. They came from 9068 different sources. 35344 (29.8% of them are assigned as FDA regulated and 25151 (21.2% as Section 801 controlled substances. Despite multiple regulatory requirements, only about 35% of trials had clinical study results deposited, the maximum 55.56% of trials with the results, was observed for trials completed in 2008. CONCLUSIONS: The most positive impact on depositing results, the imposed restrains made for hospitals and clinics. Health care companies showed much higher efficiency than other investigated classes both in higher fraction of trials with results and in providing at least one outcome for their trials. They also more often than others deposit results when it is not strictly required, particularly, in the case of non-interventional studies.

  2. Timing and completeness of trial results posted at ClinicalTrials.gov and published in journals.

    OpenAIRE

    Carolina Riveros; Agnes Dechartres; Elodie Perrodeau; Romana Haneef; Isabelle Boutron; Philippe Ravaud

    2013-01-01

    Editors' Summary Background When patients consult a doctor, they expect to be recommended what their doctor believes is the most effective treatment with the fewest adverse effects. To determine which treatment to recommend, clinicians rely on sources that include research studies. Among studies, the best evidence is generally agreed to come from systematic reviews and randomized controlled clinical trials (RCTs), studies that test the efficacy and safety of medical interventions by comparing...

  3. Timing and Completeness of Trial Results Posted at ClinicalTrials.gov and Published in Journals

    OpenAIRE

    Riveros, Carolina; Dechartres, Agnes; Perrodeau, Elodie; Haneef, Romana; Boutron, Isabelle; Ravaud, Philippe

    2013-01-01

    Editors' Summary Background When patients consult a doctor, they expect to be recommended what their doctor believes is the most effective treatment with the fewest adverse effects. To determine which treatment to recommend, clinicians rely on sources that include research studies. Among studies, the best evidence is generally agreed to come from systematic reviews and randomized controlled clinical trials (RCTs), studies that test the efficacy and safety of medical interventions by comparing...

  4. In vivo trial results of a novel ultrasonic cough stimulator

    Directory of Open Access Journals (Sweden)

    Jennifer C. Nitz, PhD, MPhty, BPhty

    2012-12-01

    Full Text Available The aims of these double-blind in-vivo trials of a prototype ultrasonic cough stimulator (CoughStim™ were to establish (1 whether ultrasound (US stimulation can be safely used to stimulate a cough, (2 the most efficient US frequency and power parameters to reliably stimulate a cough, (3 whether single- or dual-sided stimulation is more effective, and (4 whether a cough can be stimulated in adults unable to cough on demand. Fifteen nondisabled volunteers (18–59 yr and seven volunteers unable to cough on demand (85–102 yr were recruited. Stimulation was applied to the neck unilaterally at eight frequencies and two power levels and bilaterally at two frequencies and three power levels. Vital signs were monitored during testing with no adverse responses. CoughStim stimulated a cough in all nondisabled subjects, 80% of subjects at 0.58 MHz and 9 W unilaterally and 75% of subjects at 0.58 MHz and 6 W bilaterally. Of the subjects unable to cough, 71 percent responded to bilateral stimuli (0.54 MHz and 6 W with a strong cough. The CoughStim regularly and safely produced a moderately strong cough response in subjects with or without ability to cough and produced this effect without causing undue discomfort.

  5. The impact of radiologists' expertise on screen results decisions in a CT lung cancer screening trial

    NARCIS (Netherlands)

    Heuvelmans, Marjolein A.; Oudkerk, Matthijs; de Jong, Pim A.; Mali, Willem P.; Groen, Harry J. M.; Vliegenthart, Rozemarijn

    2015-01-01

    OBJECTIVE: To evaluate the impact of radiological expertise on screen result decisions in a CT lung cancer screening trial. METHODS: In the NELSON lung cancer screening trial, the baseline CT result was based on the largest lung nodule's volume. The protocol allowed radiologists to manually adjust s

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

    OpenAIRE

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

    2014-01-01

    Objective 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. Design Cohort embedded pragmatic randomized controlled trial. Setting Trials registered on ClinicalTrials.gov. Participants 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails s...

  7. Generalizability of results from the National Lung Screening Trial

    International Nuclear Information System (INIS)

    Lung cancer is the major cause of cancer-related death worldwide, with a 5-year survival of only 16 %. Most lung cancer cases are diagnosed at an advanced incurable stage. As earlier stages have a better prognosis, the key to reducing mortality could be early diagnosis of the disease. At present, low-dose computed tomographic (CT) screening has shown promising data. Lung cancer death rates were reduced by 20 % when CT screening is compared to chest radiography in a high-risk group. There are many advantages of CT screening in lung cancer, however there are also some important issues that should be taken into account. Therefore, the applicability of the results to clinical practice is not clear yet. In this Commentary we discuss different aspects that play important roles in the balance between harms and benefits of screening, including overdiagnosis, availability of treatment options worldwide, ethical considerations, costs, and prolonged life expectancy. We conclude that clinicians should be cautious in generalizing findings to the total population of smokers and take into account that the use of lung cancer screening in clinical practice may have limitations.

  8. Current clinical results of the Tsukuba BNCT trial

    Energy Technology Data Exchange (ETDEWEB)

    Yamamoto, T.; Matsumura, A. E-mail: matsumur@md.tsukuba.ac.jp; Nakai, K.; Shibata, Y.; Endo, K.; Sakurai, F.; Kishi, T.; Kumada, H.; Yamamoto, K.; Torii, Y

    2004-11-01

    Nine high grade gliomas (5 glioblastomas and 4 anaplastic astrocytomas) were treated with BSH-based intaoperative boron neutron capture therapy (IOBNCT). BSH (100 mg/kg body weight) was intravenously injected, followed by single fraction irradiation using the mixed thermal/epithermal beam of Japan Research Reactor 4. The blood boron level at the time of irradiation averaged 29.9 (18.8-39.5) {mu}g/g. The peak thermal neutron flux as determined by post-irradiation measurements varied from 1.99 to 2.77x10{sup 9} n cm{sup -2} s{sup -1}. No serious BSH-related toxicity was observed in this series. The interim survival data in this study showed median survival times of 23.2 months for glioblastoma and 25.9 months for anaplastic astrocytoma, results which are consistent with the current conventional radiotherapy with/without boost radiation. Of the 4 residual tumors, 2 showed complete response (CR) and 2 showed partial response (PR) within 6 months following BNCT. No linear correlation was proved between the dose and the occurrence of early neurological events. The maximum boron dose of 11.7-12.2 Gy in the brain related to the occurrence of radiation necrosis. The clinical application of a mixed thermal/epithermal beam and JRR-4 facilities on BSH-based IOBNCT proved to be safe and effective in this series.

  9. Is prostate cancer screening responsible for the negative results of prostate cancer treatment trials?

    Science.gov (United States)

    Prasad, Vinay

    2016-08-01

    Clinical guidelines continue to move away from routine prostate specific antigen screening (PSA), once a widespread medical practice. A curious difference exists between early prostate cancer and early breast cancer. While randomized trials of therapy in early breast cancer continue to show overall survival benefit, this is not the case in prostate cancer, where prostatectomy was no better than observation in a recent trial, and where early androgen deprivation is no better than late androgen deprivation. Here, I make the case that prostate cancer screening contributes so greatly to over diagnosis that even treatment trials yield null results due to contamination with non-life threatening disease. PMID:27372859

  10. No difference found in time to publication by statistical significance of trial results: a methodological review

    Science.gov (United States)

    Jefferson, L; Cooper, E; Hewitt, C; Torgerson, T; Cook, L; Tharmanathan, P; Cockayne, S; Torgerson, D

    2016-01-01

    Objective Time-lag from study completion to publication is a potential source of publication bias in randomised controlled trials. This study sought to update the evidence base by identifying the effect of the statistical significance of research findings on time to publication of trial results. Design Literature searches were carried out in four general medical journals from June 2013 to June 2014 inclusive (BMJ, JAMA, the Lancet and the New England Journal of Medicine). Setting Methodological review of four general medical journals. Participants Original research articles presenting the primary analyses from phase 2, 3 and 4 parallel-group randomised controlled trials were included. Main outcome measures Time from trial completion to publication. Results The median time from trial completion to publication was 431 days (n = 208, interquartile range 278–618). A multivariable adjusted Cox model found no statistically significant difference in time to publication for trials reporting positive or negative results (hazard ratio: 0.86, 95% CI 0.64 to 1.16, p = 0.32). Conclusion In contrast to previous studies, this review did not demonstrate the presence of time-lag bias in time to publication. This may be a result of these articles being published in four high-impact general medical journals that may be more inclined to publish rapidly, whatever the findings. Further research is needed to explore the presence of time-lag bias in lower quality studies and lower impact journals. PMID:27757242

  11. Normal tissue complication probability (NTCP) parameters for breast fibrosis: Pooled results from two randomised trials

    International Nuclear Information System (INIS)

    Introduction: The dose–volume effect of radiation therapy on breast tissue is poorly understood. We estimate NTCP parameters for breast fibrosis after external beam radiotherapy. Materials and methods: We pooled individual patient data of 5856 patients from 2 trials including whole breast irradiation followed with or without a boost. A two-compartment dose volume histogram model was used with boost volume as the first compartment and the remaining breast volume as second compartment. Results from START-pilot trial (n = 1410) were used to test the predicted models. Results: 26.8% patients in the Cambridge trial (5 years) and 20.7% patients in the EORTC trial (10 years) developed moderate-severe breast fibrosis. The best fit NTCP parameters were BEUD3(50) = 136.4 Gy, γ50 = 0.9 and n = 0.011 for the Niemierko model and BEUD3(50) = 132 Gy, m = 0.35 and n = 0.012 for the Lyman Kutcher Burman model. The observed rates of fibrosis in the START-pilot trial agreed well with the predicted rates. Conclusions: This large multi-centre pooled study suggests that the effect of volume parameter is small and the maximum RT dose is the most important parameter to influence breast fibrosis. A small value of volume parameter ‘n’ does not fit with the hypothesis that breast tissue is a parallel organ. However, this may reflect limitations in our current scoring system of fibrosis

  12. Environmental life cycle information management and acquisition - first experiences and results from field trials

    Energy Technology Data Exchange (ETDEWEB)

    Bodenhoefer, K.; Schneider, A. [Sony International (Europe) GmbH (SIE), Stuttgart (Germany); Cock, T.; Brooks, A.; Sands, G. [Merloni Elletrodomestici, Stoke-on-Trent (United Kingdom); Allman, L.; Simon, M. [Sheffield Hallam Univ., Sheffield (United Kingdom); Chong, S.K.; Yang, K. [De Montfort Univ., Leicester (United Kingdom); Delannoy, O.; Catanese, B. [Cybernetix, Rousset (France); Mueller, K. [Motorola GmbH, Taunusstein (Germany)

    2004-07-01

    An improved control of product life cycles enables a more sustainable use of resources. In the EU co-funded project ELIMA (Environmental Life Cycle Information Management and Acquisition for Consumer Products) both hard- and software tools are developed to record and manage reliable product life cycle data to improve service/repair and recycling/reuse as well as product design. Field trials with demonstrator products from two categories - consumer electronics and large household appliances - are running until August 2004. Data collection and general analysis is performed with the help of the internet-based ELIMA information management system. This paper describes the applied data acquisition and data management technologies and the field trials in which they are tested. First field trial results are presented both as a general data interpretation and as subsequent customer oriented analysis. Linked to this, user acceptance survey results from UK and Germany and the conclusions drawn are discussed. (orig.)

  13. Perceptions and Referral Trends into Phase I Oncology Trials: Results of a Clinical Survey

    Directory of Open Access Journals (Sweden)

    Andre Brunetto

    2011-01-01

    Full Text Available Introduction. A survey was sent to referring oncologists (ROs to explore the reasons behind their referral patterns and perceptions of Phase I studies before and after being provided with outcome data from advanced colorectal cancer (ACRC patients who participated in Phase I trials at the Royal Marsden Hospital (RMH. Results. The response rate was 32/50 (64%. The most common reason for referral was exhaustion of standard treatments (31%, and the main reason for referring to the RMH was proximity to patients (28%. The most frequent clinical parameter assessed prior to referral was performance status (93%. ROs spent a median of 15 min (range: 5–45 min discussing general aspects of Phase I trials. In the second part of the questionnaire, after reviewing clinical outcome data of ACRC patients who participated in Phase I trials, 47% would change their approach, specifically, spend more time to discuss risks and benefits of Phase I trials (9%, consider prognostic factors before referral (13%, and increase the number of referrals (25%. Conclusion. This is the first report focusing on communication between ROs and a specialist Phase I unit. Outcome reporting can improve communication with ROs and importantly has the potential for better patient selection considered for Phase I oncology trials.

  14. Beyond PubMed: Searching the "Grey Literature" for Clinical Trial Results.

    Science.gov (United States)

    Citrome, Leslie

    2014-07-01

    Clinical trial results have been traditionally communicated through the publication of scholarly reports and reviews in biomedical journals. However, this dissemination of information can be delayed or incomplete, making it difficult to appraise new treatments, or in the case of missing data, evaluate older interventions. Going beyond the routine search of PubMed, it is possible to discover additional information in the "grey literature." Examples of the grey literature include clinical trial registries, patent databases, company and industrywide repositories, regulatory agency digital archives, abstracts of paper and poster presentations on meeting/congress websites, industry investor reports and press releases, and institutional and personal websites.

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

    DEFF Research Database (Denmark)

    Lynge, Elsebeth; Rebolj, Matejka

    2009-01-01

    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 tes...

  16. A Parent-Adolescent Intervention to Increase Sexual Risk Communication: Results of a Randomized Controlled Trial

    Science.gov (United States)

    Villarruel, Antonia M.; Cherry, Carol Loveland; Cabriales, Esther Gallegos; Ronis, David L.; Zhou, Yan

    2008-01-01

    This article reports results of a randomized controlled trial designed to test an intervention to increase parent-adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HIV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6-…

  17. Competitive Employment for Youth with Autism Spectrum Disorders: Early Results from a Randomized Clinical Trial

    Science.gov (United States)

    Wehman, Paul H.; Schall, Carol M.; McDonough, Jennifer; Kregel, John; Brooke, Valerie; Molinelli, Alissa; Ham, Whitney; Graham, Carolyn W.; Riehle, J. Erin; Collins, Holly T.; Thiss, Weston

    2014-01-01

    For most youth with autism spectrum disorders (ASD), employment upon graduation from high school or college is elusive. Employment rates are reported in many studies to be very low despite many years of intensive special education services. This paper presented the preliminary results of a randomized clinical trial of Project SEARCH plus ASD…

  18. Acupuncture is a feasible treatment for post-thoracotomy pain: results of a prospective pilot trial

    Directory of Open Access Journals (Sweden)

    Malhotra Vivek T

    2006-05-01

    Full Text Available Abstract Background Thoracotomy is associated with severe pain that may persist for years. Acupuncture is a complementary therapy with a proven role in pain control. A randomized trial showed that acupuncture was effective in controlling pain after abdominal surgery, but the efficacy of this technique for the treatment of thoracotomy pain has not been established. We developed a novel technique for convenient application of acupuncture to patients undergoing thoracotomy, and in a Phase II trial evaluated the safety of this intervention and the feasibility of doing a randomized trial. Methods Adult patients scheduled for unilateral thoracotomy with preoperative epidural catheter placement received acupuncture immediately prior to surgery. Eighteen semi-permanent intradermal needles were inserted on either side of the spine, and four were inserted in the legs and auricles. Needles were removed after four weeks. Using a numerical rating scale, pain was measured on the first five postoperative days. After discharge, pain was assessed using the Brief Pain Inventory at 7, 30, 60 and 90 days. Results Thirty-six patients were treated with acupuncture. Of these, 25, 23, and 22 patients provided data at 30, 60, and 90 days, respectively. The intervention was well tolerated by patients with only one minor and transient adverse event of skin ulceration. Conclusion The rate of data completion met our predefined criterion for determining a randomized trial to be feasible (at least 75% of patients tolerated the intervention and provided evaluable data. This novel intervention is acceptable to patients undergoing thoracotomy and does not interfere with standard preoperative care. There was no evidence of important adverse events. We are now testing the hypothesis that acupuncture significantly adds to standard perioperative pain management in a randomized trial.

  19. Return of individual research results and incidental findings in the clinical trials cooperative group setting.

    Science.gov (United States)

    Ferriere, Michael; Van Ness, Brian

    2012-04-01

    The National Cancer Institute (NCI)-funded cooperative group cancer clinical trial system develops experimental therapies and often collects samples from patients for correlative research. The cooperative group bank (CGB) system maintains biobanks with a current policy not to return research results to individuals. An online survey was created, and 10 directors of CGBs completed the surveys asking about understanding and attitudes in changing policies to consider return of incidental findings (IFs) and individual research results (IRRs) of health significance. The potential impact of the 10 consensus recommendations of Wolf et al. presented in this issue are examined. Reidentification of samples is often not problematic; however, changes to the current banking and clinical trial systems would require significant effort to fulfill an obligation of recontact of subjects. Additional resources, as well as a national advisory board would be required to standardize implementation.

  20. Negative results in phase III trials of complex interventions: cause for concern or just good science?

    Science.gov (United States)

    Crawford, Mike J; Barnicot, Kirsten; Patterson, Sue; Gold, Christian

    2016-07-01

    Not all interventions that show promise in exploratory trials will be supported in phase III studies. But the high failure rate in recent trials of complex mental health interventions is a concern. Proper consideration of trial processes and greater use of adaptive trial designs could ensure better use of available resources. PMID:27369475

  1. Gestational Weight Gain: Results from the Delta Healthy Sprouts Comparative Impact Trial

    Directory of Open Access Journals (Sweden)

    Jessica L. Thomson

    2016-01-01

    Full Text Available Introduction. Delta Healthy Sprouts trial was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of Southern African American women and their infants. Results pertaining to the primary outcome, gestational weight gain, are reported. Methods. Participants (n=82, enrolled early in their second trimester of pregnancy, were randomly assigned to one of two treatment arms. Gestational weight gain, measured at six monthly home visits, was calculated by subtracting measured weight at each visit from self-reported prepregnancy weight. Weight gain was classified as under, within, or exceeding the Institute of Medicine recommendations based on prepregnancy body mass index. Chi-square tests and generalized linear mixed models were used to test for significant differences in percentages of participants within recommended weight gain ranges. Results. Differences in percentages of participants within the gestational weight gain guidelines were not significant between treatment arms across all visits. Conclusions. Enhancing the gestational nutrition and physical activity components of an existing home visiting program is feasible in a high risk population of primarily low income African American women. The impact of these enhancements on appropriate gestational weight gain is questionable given the more basic living needs of such women. This trial is registered with ClinicalTrials.gov NCT01746394, registered 4 December 2012.

  2. Gestational Weight Gain: Results from the Delta Healthy Sprouts Comparative Impact Trial

    Science.gov (United States)

    Olender, Sarah E.

    2016-01-01

    Introduction. Delta Healthy Sprouts trial was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of Southern African American women and their infants. Results pertaining to the primary outcome, gestational weight gain, are reported. Methods. Participants (n = 82), enrolled early in their second trimester of pregnancy, were randomly assigned to one of two treatment arms. Gestational weight gain, measured at six monthly home visits, was calculated by subtracting measured weight at each visit from self-reported prepregnancy weight. Weight gain was classified as under, within, or exceeding the Institute of Medicine recommendations based on prepregnancy body mass index. Chi-square tests and generalized linear mixed models were used to test for significant differences in percentages of participants within recommended weight gain ranges. Results. Differences in percentages of participants within the gestational weight gain guidelines were not significant between treatment arms across all visits. Conclusions. Enhancing the gestational nutrition and physical activity components of an existing home visiting program is feasible in a high risk population of primarily low income African American women. The impact of these enhancements on appropriate gestational weight gain is questionable given the more basic living needs of such women. This trial is registered with ClinicalTrials.gov NCT01746394, registered 4 December 2012. PMID:27595023

  3. Infant feeding bottle design, growth and behaviour: results from a randomised trial

    Directory of Open Access Journals (Sweden)

    Fewtrell MS

    2012-03-01

    Full Text Available Abstract Background Whether the design of an anti-vacuum infant feeding bottle influences infant milk intake, growth or behavior is unknown, and was the subject of this randomized trial. Methods Subjects 63 (36 male healthy, exclusively formula-fed term infants. Intervention Randomisation to use Bottle A (n = 31, one-way air valve: Philips Avent versus Bottle B (n = 32, internal venting system: Dr Browns. 74 breast-fed reference infants were recruited, with randomisation (n = 24 to bottle A (n = 11 or B (n = 13 if bottle-feeding was subsequently introduced. Randomisation stratified by gender and parity; computer-based telephone randomisation by independent clinical trials unit. Setting Infant home. Primary outcome measure infant weight gain to 4 weeks. Secondary outcomes (i milk intake (ii infant behaviour measured at 2 weeks (validated 3-day diary; (iii risk of infection; (iv continuation of breastfeeding following introduction of mixed feeding. Results Number analysed for primary outcome Bottle A n = 29, Bottle B n = 25. Primary outcome There was no significant difference in weight gain between randomised groups (0-4 weeks Bottle A 0.74 (SD 1.2 SDS versus bottle B 0.51 (0.39, mean difference 0.23 (95% CI -0.31 to 0.77. Secondary outcomes Infants using bottle A had significantly less reported fussing (mean 46 versus 74 minutes/day, p Breast-fed reference group There were no significant differences in primary or secondary outcomes between breast-fed and formula fed infants. The likelyhood of breastfeeding at 3 months was not significantly different in infants subsequently randomised to bottle A or B. Conclusion Bottle design may have short-term effects on infant behaviour which merit further investigation. No significant effects were seen on milk intake or growth; confidence in these findings is limited by the small sample size and this needs confirmation in a larger study. Trial registration Clinical Trials.gov NCT00325208.

  4. Results of the Randomized Danish Lung Cancer Screening Trial with Focus on High-Risk Profiling

    DEFF Research Database (Denmark)

    M. W. Wille, Mathilde; Dirksen, Asger; Ashraf, Haseem;

    2016-01-01

    RATIONALE: As of April 2015, participants in the Danish Lung Cancer Screening Trial had been followed for at least 5 years since their last screening. OBJECTIVES: Mortality, causes of death, and lung cancer findings are reported to explore the effect of computed tomography (CT) screening. METHODS...... fewer deaths in the screening group. CONCLUSIONS: No statistically significant effects of CT screening on lung cancer mortality were found, but the results of post hoc high-risk subgroup analyses showed nonsignificant trends that seem to be in good agreement with the results of the National Lung...

  5. Intraoperative photodynamic therapy of bladder cancer with alasens (results of multicenter trial

    Directory of Open Access Journals (Sweden)

    E. V. Filonenko

    2014-01-01

    Full Text Available The results of multicenter prospective trial for efficacy of combined modality treatment: transurethral resection (TUR + photodynamic therapy (PDT with alasens for bladder cancer are represented in the article. Trials were organized by Research Institute of Organic Intermediates and Dyes and conducted according to clinical protocol approved by Ministry of Health of Russia, at the sites of leading Russian cancer clinical centers. The trial included 45 subjects with verified diagnosis of non-muscle-invasive bladder cancer. Patients underwent TUR of bladder with simultaneous PDT as anti-relapse treatment. Alasens was administered to patients as intravesicular instillation of 3% solution in volume of 50 ml with 1.5–2h exposure (prior to TUR. TUR was performed after instillation. PDT session was conducted immediately after the completion of TUR on a single occasion by means of combined local irradiation on tumor bed with diffuse irradiation on whole urinary bladder mucosa (light dose of local irradiation – 100 J/cm2, diffuse irradiation – 20 J/cm2. Good tolerance of the treatment was noticed, there were no complications. Among 45 patients included in the trial, 35 (78% completed 12 month protocol follow-up without relapse. The recurrence of bladder tumor was registered in 10 (22% cases 6–12 months after TUR+PDT including 3 patients with recurrence 6 months after treatment, 3–9 months and 4–12 months. These patients underwent repeated TUR, whereafter their follow-up in the settings of the clinical trial was disposed. Thus, PDT with alasens after TUR allowed to decrease the recurrence rate of non-muscle-invasive bladder cancer for 1st year after treatment to 22% versus 40–80% for TUR as monotherapy according to literature data. The obtained results were comparable by efficiency with TUR combined with methods of adjuvant treatment for bladder tumors (the recurrence rates for 1-year follow-up after TUR+chemotherapy – 36–44%, after TUR

  6. Mavoglurant in fragile X syndrome: Results of two randomized, double-blind, placebo-controlled trials.

    Science.gov (United States)

    Berry-Kravis, Elizabeth; Des Portes, Vincent; Hagerman, Randi; Jacquemont, Sébastien; Charles, Perrine; Visootsak, Jeannie; Brinkman, Marc; Rerat, Karin; Koumaras, Barbara; Zhu, Liansheng; Barth, Gottfried Maria; Jaecklin, Thomas; Apostol, George; von Raison, Florian

    2016-01-13

    Fragile X syndrome (FXS), the most common cause of inherited intellectual disability and autistic spectrum disorder, is typically caused by transcriptional silencing of the X-linked FMR1 gene. Work in animal models has described altered synaptic plasticity, a result of the up-regulation of metabotropic glutamate receptor 5 (mGluR5)-mediated signaling, as a putative downstream effect. Post hoc analysis of a randomized, placebo-controlled, crossover phase 2 trial suggested that the selective mGluR5 antagonist mavoglurant improved behavioral symptoms in FXS patients with completely methylated FMR1 genes. We present the results of two phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of mavoglurant in FXS, designed to confirm this result in adults (n = 175, aged 18 to 45 years) and adolescents (n = 139, aged 12 to 17 years). In both trials, participants were stratified by methylation status and randomized to receive mavoglurant (25, 50, or 100 mg twice daily) or placebo over 12 weeks. Neither of the studies achieved the primary efficacy end point of improvement on behavioral symptoms measured by the Aberrant Behavior Checklist-Community Edition using the FXS-specific algorithm (ABC-C(FX)) after 12 weeks of treatment with mavoglurant. The safety and tolerability profile of mavoglurant was as previously described, with few adverse events. Therefore, under the conditions of our study, we could not confirm the mGluR theory of FXS nor the ability of the methylation state of the FMR1 promoter to predict mavoglurant efficacy. Preclinical results suggest that future clinical trials might profitably explore initiating treatment in a younger population with longer treatment duration and longer placebo run-ins and identifying new markers to better assess behavioral and cognitive benefits.

  7. Final results from the large sunitinib global expanded-access trial in metastatic renal cell carcinoma

    Science.gov (United States)

    Gore, M E; Szczylik, C; Porta, C; Bracarda, S; Bjarnason, G A; Oudard, S; Lee, S-H; Haanen, J; Castellano, D; Vrdoljak, E; Schöffski, P; Mainwaring, P; Hawkins, R E; Crinò, L; Kim, T M; Carteni, G; Eberhardt, W E E; Zhang, K; Fly, K; Matczak, E; Lechuga, M J; Hariharan, S; Bukowski, R

    2015-01-01

    Background: We report final results with extended follow-up from a global, expanded-access trial that pre-regulatory approval provided sunitinib to metastatic renal cell carcinoma (mRCC) patients, ineligible for registration-directed trials. Methods: Patients ⩾18 years received oral sunitinib 50 mg per day on a 4-weeks-on–2-weeks-off schedule. Safety was assessed regularly. Tumour measurements were scheduled per local practice. Results: A total of 4543 patients received sunitinib. Median treatment duration and follow-up were 7.5 and 13.6 months. Objective response rate was 16% (95% confidence interval (CI): 15–17). Median progression-free survival (PFS) and overall survival (OS) were 9.4 months (95% CI: 8.8–10.0) and 18.7 months (95% CI: 17.5–19.5). Median PFS in subgroups of interest: aged ⩾65 years (33%), 10.1 months; Eastern Cooperative Oncology Group performance status ⩾2 (14%), 3.5 months; non-clear cell histology (12%), 6.0 months; and brain metastases (7%), 5.3 months. OS was strongly associated with the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model (n=4065). The most common grade 3/4 treatment-related adverse events were thrombocytopenia (10%), fatigue (9%), and asthenia, neutropenia, and hand–foot syndrome (each 7%). Conclusion: Final analysis of the sunitinib expanded-access trial provided a good opportunity to evaluate the long-term side effects of a tyrosine kinase inhibitor used worldwide in mRCC. Efficacy and safety findings were consistent with previous results. PMID:26086878

  8. New oral anticoagulants in atrial fibrillation: a reappraisal of trial results looking at absolute figures.

    Science.gov (United States)

    Coccheri, Sergio; Orlando, Donatella

    2013-03-01

    Three new oral anticoagulant agents were tested versus warfarin in separate, large phase III randomized clinical trials for prevention of any stroke and systemic embolism in atrial fibrillation. Dabigatran, a direct thrombin inhibitor, is at 110 mg bid non-inferior and at 150 mg bid superior to warfarin; rivaroxaban, a factor X inhibitor, is also non-inferior, and apixaban, also a factor X inhibitor, is superior to warfarin on the same efficacy end point. Statistical analysis of subgroups does not suggest, for any of the tested drugs, major differences in relation to different risk levels and history of previous stroke/TIA. This re-appraisal of data was undertaken in search for possible additional information, by considering the absolute differences in efficacy and safety events versus warfarin and the corresponding efficiency and number needed to treat, also with regard to secondary versus primary prevention. By this approach, it appears that for all drugs, equivalence or advantage versus warfarin on the efficacy end point is largely driven by a reduction in hemorrhagic rather than ischemic strokes. Dabigatran shows a balanced effect on ischemic and hemorrhagic strokes, and apixaban is most effective in sparing intracranial bleeding versus warfarin. In secondary prevention, better efficiency is shown by dabigatran 150 and apixaban, versus rivaroxaban, despite the higher proportion of post-stroke/TIA patients (55 %) in the ROCKET AF trial of rivaroxaban seemed to favor better results of this drug in secondary prevention. These and other results of our approach should not be directly translated into clinical practice. They may supply useful suggestions to be subsequently tested in specific trials, although head-to-head comparative studies of the three drugs remain unlikely. PMID:23247681

  9. 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

  10. PREVALENCE OF COCCIDIOSIS IN DOGS ALONG WITH HAEMATOLOGICAL ALTERATIONS AS A RESULT OF CHEMOTHERAPEUTIC TRIAL

    Directory of Open Access Journals (Sweden)

    M. NISAR, J. A. KHAN1, M. S. KHAN1 AND I. A. KHAN

    2009-07-01

    Full Text Available A case control study was conducted on 200 dogs to ascertain the prevalence of coccidiosis (Isosporiosis. A chemotherapeutic trial was also conducted to compare the efficacy of Co-trimoxazole and Furazolidone along with the effect of Isosporiosis and medication on various haematological parameters. The prevalence of Isospriosis was 18%. In chemotherapeutic trial, 30 naturally infected dogs were randomly divided into three equal groups A, B and C. Group A was treated with Co-trimoxazole (15 mg/kg orally, Group B with Furazolidone (8 mg/kg orally, while Group C was kept as infected non-medicated control. Group D consisting of 10 non infected dogs was kept as non infected non medicated control. The efficacies of these chemotherapeutic agents were evaluated by counting oocysts per gram (OPG of faeces on day 0, 3, 7 and 10 post medication. The results revealed that Co-trimoxazloe and Furazolidone had 97 and 95% efficacy, respectively. As a result of treatment in groups A and B, the values of haemoglobin and packed cell volume significantly increased on day 3, 7 and 10 post-medication. It was concluded that Co-trimoxazole and Furazolidone both were effective against coccidiosis in dogs but Co-trimoxazole was better than Furazolidone.

  11. The "Healthy Habits, Healthy Girls" randomized controlled trial for girls: study design, protocol, and baseline results.

    Science.gov (United States)

    Leme, Ana Carolina Barco; Philippi, Sonia Tucunduva

    2015-07-01

    The purpose of this article is to describe the study design, protocol, and baseline results of the "Healthy Habits, Healthy Girls" program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field. PMID:26248094

  12. Method for evaluating prediction models that apply the results of randomized trials to individual patients

    Directory of Open Access Journals (Sweden)

    Kattan Michael W

    2007-06-01

    Full Text Available Abstract Introduction The clinical significance of a treatment effect demonstrated in a randomized trial is typically assessed by reference to differences in event rates at the group level. An alternative is to make individualized predictions for each patient based on a prediction model. This approach is growing in popularity, particularly for cancer. Despite its intuitive advantages, it remains plausible that some prediction models may do more harm than good. Here we present a novel method for determining whether predictions from a model should be used to apply the results of a randomized trial to individual patients, as opposed to using group level results. Methods We propose applying the prediction model to a data set from a randomized trial and examining the results of patients for whom the treatment arm recommended by a prediction model is congruent with allocation. These results are compared with the strategy of treating all patients through use of a net benefit function that incorporates both the number of patients treated and the outcome. We examined models developed using data sets regarding adjuvant chemotherapy for colorectal cancer and Dutasteride for benign prostatic hypertrophy. Results For adjuvant chemotherapy, we found that patients who would opt for chemotherapy even for small risk reductions, and, conversely, those who would require a very large risk reduction, would on average be harmed by using a prediction model; those with intermediate preferences would on average benefit by allowing such information to help their decision making. Use of prediction could, at worst, lead to the equivalent of an additional death or recurrence per 143 patients; at best it could lead to the equivalent of a reduction in the number of treatments of 25% without an increase in event rates. In the Dutasteride case, where the average benefit of treatment is more modest, there is a small benefit of prediction modelling, equivalent to a reduction of

  13. Production trials involving use of the FAMACHA© system for haemonchosis in sheep : preliminary results

    Directory of Open Access Journals (Sweden)

    J.A. Van Wyk

    2008-09-01

    Full Text Available In three trials conducted on two separate farms the production of sheep treated for naturally acquired haemonchosis using the FAMACHA© system of targeted selective treatment (TST (i.e. to treat only those animals unable to manage unaided in the face of heavy Haemonchus challenge was compared to that of suppressively drenched sheep in the same flock. As expected by the research team who developed and evaluated the FAMACHA© system, TST did result in some loss in production. However, despite high levels of worm challenge in two of the trials and the fact that the comparison was with suppressive drenching which is not sustainable, the total effect was relatively small in relation to the important advantage of using the TST as regards reduced selection for anthelmintic resistance (AR. Concerning the sustainability of worm control, it is concluded that the development of drug resistance to anthelmintics leaves sheep and goat farmers in South Africa no choice but to use methods of TST such as FAMACHA©. The FAMACHA© system can also be a useful clinical aid for early on-farm detection of AR by farmers; the degree of improvement in the colour of the ocular mucous membrane from pale to red in individually drenched anaemic animals over a period of 7-14 days can give a good indication of the efficacy of the compound(s used.

  14. Recruiting young adults into a weight loss trial: report of protocol development and recruitment results.

    Science.gov (United States)

    Corsino, Leonor; Lin, Pao-Hwa; Batch, Bryan C; Intille, Stephen; Grambow, Steven C; Bosworth, Hayden B; Bennett, Gary G; Tyson, Crystal; Svetkey, Laura P; Voils, Corrine I

    2013-07-01

    Obesity has spread to all segments of the U.S. population. Young adults, aged 18-35 years, are rarely represented in clinical weight loss trials. We conducted a qualitative study to identify factors that may facilitate recruitment of young adults into a weight loss intervention trial. Participants were 33 adults aged 18-35 years with BMI ≥25 kg/m(2). Six group discussions were conducted using the nominal group technique. Health, social image, and "self" factors such as emotions, self-esteem, and confidence were reported as reasons to pursue weight loss. Physical activity, dietary intake, social support, medical intervention, and taking control (e.g. being motivated) were perceived as the best weight loss strategies. Incentives, positive outcomes, education, convenience, and social support were endorsed as reasons young adults would consider participating in a weight loss study. Incentives, advertisement, emphasizing benefits, and convenience were endorsed as ways to recruit young adults. These results informed the Cellphone Intervention for You (CITY) marketing and advertising, including message framing and advertising avenues. Implications for recruitment methods are discussed. PMID:23591327

  15. Diet, Supplement Use, and Prostate Cancer Risk: Results From the Prostate Cancer Prevention Trial

    OpenAIRE

    Kristal, Alan R.; Arnold, Kathryn B.; Neuhouser, Marian L; Goodman, Phyllis; Platz, Elizabeth A.; Albanes, Demetrius; Thompson, Ian M

    2010-01-01

    The authors examined nutritional risk factors for prostate cancer among 9,559 participants in the Prostate Cancer Prevention Trial (United States and Canada, 1994–2003). The presence or absence of cancer was determined by prostate biopsy, which was recommended during the trial because of an elevated prostate-specific antigen level or an abnormal digital rectal examination and was offered to all men at the trial's end. Nutrient intake was assessed using a food frequency questionnaire and a str...

  16. Why are clinicians not embracing the results from pivotal clinical trials in severe sepsis? A bayesian analysis.

    Directory of Open Access Journals (Sweden)

    Andre C Kalil

    Full Text Available BACKGROUND: Five pivotal clinical trials (Intensive Insulin Therapy; Recombinant Human Activated Protein C [rhAPC]; Low-Tidal Volume; Low-Dose Steroid; Early Goal-Directed Therapy [EGDT] demonstrated mortality reduction in patients with severe sepsis and expert guidelines have recommended them to clinical practice. Yet, the adoption of these therapies remains low among clinicians. OBJECTIVES: We selected these five trials and asked: Question 1--What is the current probability that the new therapy is not better than the standard of care in my patient with severe sepsis? Question 2--What is the current probability of reducing the relative risk of death (RRR of my patient with severe sepsis by meaningful clinical thresholds (RRR >15%; >20%; >25%? METHODS: Bayesian methodologies were applied to this study. Odds ratio (OR was considered for Question 1, and RRR was used for Question 2. We constructed prior distributions (enthusiastic; mild, moderate, and severe skeptic based on various effective sample sizes of other relevant clinical trials (unfavorable evidence. Posterior distributions were calculated by combining the prior distributions and the data from pivotal trials (favorable evidence. MAIN FINDINGS: Answer 1--The analysis based on mild skeptic prior shows beneficial results with the Intensive Insulin, rhAPC, and Low-Tidal Volume trials, but not with the Low-Dose Steroid and EGDT trials. All trials' results become unacceptable by the analyses using moderate or severe skeptic priors. Answer 2--If we aim for a RRR>15%, the mild skeptic analysis shows that the current probability of reducing death by this clinical threshold is 88% for the Intensive Insulin, 62-65% for the Low-Tidal Volume, rhAPC, EGDT trials, and 17% for the Low-Dose Steroid trial. The moderate and severe skeptic analyses show no clinically meaningful reduction in the risk of death for all trials. If we aim for a RRR >20% or >25%, all probabilities of benefits become lower

  17. 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...

  18. Bright Light for Weight Loss: Results of a Controlled Crossover Trial

    Directory of Open Access Journals (Sweden)

    Konstantin V. Danilenko

    2013-02-01

    Full Text Available Objective: To investigate whether bright light treatment can reduce body mass in overweight subjects irrespective of their seasonal (= light dependence. Methods: A crossover, placebo-controlled, randomized clinical trial was performed between November and April in Novosibirsk, Russia (55° N. The trial comprised a 3-week in-home session of morning bright light treatment using a device of light-emitting diodes and a 3-week placebo session by means of a deactivated ion generator, separated by an off-protocol period of at least 23 days. The number of placebo and light sessions was matched with respect to season. Data were obtained from 34 overweight women, aged 20-54 years, 10 were seasonal-dependent according to the Seasonal Pattern Assessment Questionnaire. Weekly measures included body weight, percentage body fat by bioimpedancemetry, and subjective scores (appetite, mood, energy levels. Results: Motivation and expectation towards weight loss were similar for the two intervention sessions. With light, compared to the placebo session, weight did not reduce significantly, but percentage fat, fat mass, and appetite were significantly lower (average fat reduction 0.35 kg. The latter two results remained significant after excluding seasonal-dependent subjects from the analysis. Irrespective of the type of intervention, seasonal-dependent subjects had greater weight and fat mass changes during treatment (decline p 0.036 or between sessions (regain p 0.003. Photoperiod (p = 0.0041, air temperature to a lesser extent (p = 0.012, but not sunshine (p = 0.29 was associated with the weight change (greater weight reduction if the second session was in spring. Conclusion: Morning bright light treatment reduces body fat and appetite in overweight women and may be included in weight control programs.

  19. Determinants of rapid weight gain during infancy: baseline results from the NOURISH randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Mihrshahi Seema

    2011-11-01

    Full Text Available Abstract Background Rapid weight gain in infancy is an important predictor of obesity in later childhood. Our aim was to determine which modifiable variables are associated with rapid weight gain in early life. Methods Subjects were healthy infants enrolled in NOURISH, a randomised, controlled trial evaluating an intervention to promote positive early feeding practices. This analysis used the birth and baseline data for NOURISH. Birthweight was collected from hospital records and infants were also weighed at baseline assessment when they were aged 4-7 months and before randomisation. Infant feeding practices and demographic variables were collected from the mother using a self administered questionnaire. Rapid weight gain was defined as an increase in weight-for-age Z-score (using WHO standards above 0.67 SD from birth to baseline assessment, which is interpreted clinically as crossing centile lines on a growth chart. Variables associated with rapid weight gain were evaluated using a multivariable logistic regression model. Results Complete data were available for 612 infants (88% of the total sample recruited with a mean (SD age of 4.3 (1.0 months at baseline assessment. After adjusting for mother's age, smoking in pregnancy, BMI, and education and infant birthweight, age, gender and introduction of solid foods, the only two modifiable factors associated with rapid weight gain to attain statistical significance were formula feeding [OR = 1.72 (95%CI 1.01-2.94, P = 0.047] and feeding on schedule [OR = 2.29 (95%CI 1.14-4.61, P = 0.020]. Male gender and lower birthweight were non-modifiable factors associated with rapid weight gain. Conclusions This analysis supports the contention that there is an association between formula feeding, feeding to schedule and weight gain in the first months of life. Mechanisms may include the actual content of formula milk (e.g. higher protein intake or differences in feeding styles, such as feeding to schedule

  20. 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...

  1. Finasteride concentrations and prostate cancer risk: results from the Prostate Cancer Prevention Trial.

    Directory of Open Access Journals (Sweden)

    Cindy H Chau

    Full Text Available In the Prostate Cancer Prevention Trial (PCPT, finasteride reduced the risk of prostate cancer by 25%, even though high-grade prostate cancer was more common in the finasteride group. However, it remains to be determined whether finasteride concentrations may affect prostate cancer risk. In this study, we examined the association between serum finasteride concentrations and the risk of prostate cancer in the treatment arm of the PCPT and determined factors involved in modifying drug concentrations.Data for this nested case-control study are from the PCPT. Cases were drawn from men with biopsy-proven prostate cancer and matched controls. Finasteride concentrations were measured using a liquid chromatography-mass spectrometry validated assay. The association of serum finasteride concentrations with prostate cancer risk was determined by logistic regression. We also examine whether polymorphisms in the enzyme target and metabolism genes of finasteride are related to drug concentrations using linear regression.Among men with detectable finasteride concentrations, there was no association between finasteride concentrations and prostate cancer risk, low-grade or high-grade, when finasteride concentration was analyzed as a continuous variable or categorized by cutoff points. Since there was no concentration-dependent effect on prostate cancer, any exposure to finasteride intake may reduce prostate cancer risk. Of the twenty-seven SNPs assessed in the enzyme target and metabolism pathway, five SNPs in two genes, CYP3A4 (rs2242480; rs4646437; rs4986910, and CYP3A5 (rs15524; rs776746 were significantly associated with modifying finasteride concentrations. These results suggest that finasteride exposure may reduce prostate cancer risk and finasteride concentrations are affected by genetic variations in genes responsible for altering its metabolism pathway.ClinicalTrials.gov NCT00288106.

  2. Diaphragm Used with Replens Gel and Risk of Bacterial Vaginosis: Results from a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Craig R. Cohen

    2012-01-01

    Full Text Available Background. Bacterial vaginosis (BV has been linked to female HIV acquisition and transmission. We investigated the effect of providing a latex diaphragm with Replens and condoms compared to condom only on BV prevalence among participants enrolled in an HIV prevention trial. Methods. We enrolled HIV-seronegative women and obtained a vaginal swab for diagnosis of BV using Nugent’s criteria; women with BV (score 7–10 were compared to those with intermediate (score 4–6 and normal flora (score 0–3. During quarterly follow-up visits over 12–24 months a vaginal Gram stain was obtained. The primary outcome was serial point prevalence of BV during followup. Results. 528 participants were enrolled; 213 (40% had BV at enrollment. Overall, BV prevalence declined after enrollment in women with BV at baseline (OR=0.4, 95% CI 0.29–.56 but did not differ by intervention group. In the intention-to-treat analysis BV prevalence did not differ between the intervention and control groups for women who had BV (OR=1.01, 95% CI 0.52–1.94 or for those who did not have BV (OR=1.21, 95% CI 0.65–2.27 at enrollment. Only 2.1% of participants were treated for symptomatic BV and few women (5–16% were reported using anything else but water to cleanse the vagina over the course of the trial. Conclusions. Provision of the diaphragm, Replens, and condoms did not change the risk of BV in comparison to the provision of condoms alone.

  3. Neoadjuvant radiochemotherapy for locally advanced gastric cancer: Long-term results of a phase I trial

    International Nuclear Information System (INIS)

    Purpose: To assess the long-term results of radiation therapy (RT) when added preoperatively to systemic chemotherapy in patients with locally advanced gastric cancer. Methods and Materials: Patients presenting with T3-4 or N+ gastric cancer received two cycles of cisplatin 100 mg/m2 d1, 5FU 800 mg/m2 d1-4, and Leucovorin 60 mg twice daily d1-4; one cycle before and one concomitantly with hyperfractionated RT (median dose, 38.4; range, 31.2-45.6 Gy). All patients underwent a total or subtotal gastrectomy with D2 lymph node resection. Results: Nineteen patients were accrued and 18 completed the neoadjuvant therapeutic program. All patients were subsequently operated and no fatality occurred. At a mean follow-up of 8 years for the surviving patients, no severe late toxicity was observed. The 5-year locoregional control, disease-free, and overall survival were of 85%, 41%, and 35%, respectively. The peritoneum was the most frequent site of relapse. Among long terms survivors, no severe (Radiation Therapy Oncology Group Grade 3-4) late complication was reported. Conclusions: The present neoadjuvant treatment does not seem to increase the operative risk, nor the late side effects. The encouraging locoregional control rate suggests that the neoadjuvant approach should be considered for future trials in locally advanced gastric cancer. Also, the frequency of peritoneal recurrence stresses the need for a more efficient systemic or intraperitoneal treatment

  4. Potentiality and Boundaries of Use of Sorafenib in Patients with Hepatocellular Carcinoma: Awaiting the Results of Ongoing Clinical Trials

    Directory of Open Access Journals (Sweden)

    Bruno Daniele

    2012-06-01

    Full Text Available No systemic therapy had been proven effective in patients with advanced hepatocellular carcinoma (HCC until 2007, when a large randomized trial with sorafenib demonstrated a clinically relevant prolongation of survival. Currently, sorafenib represents standard treatment for patients with advanced HCC and well-preserved liver function, whilst the evidence about its effectiveness in patients with more severe liver impairment is less robust. A randomized trial to demonstrate the efficacy of sorafenib in Child-Pugh B patients with advanced HCC is currently ongoing. In the meantime, several trials are testing the role of sorafenib in early HCC (as adjuvant treatment after potentially curative loco-regional therapies and in intermediate stage (exploring different modalities of integration of sorafenib with trans-arterial chemo-embolization. The results of all these trials will better define the potentiality and the boundaries of use of sorafenib in HCC patients.

  5. Potentiality and Boundaries of Use of Sorafenib in Patients with Hepatocellular Carcinoma: Awaiting the Results of Ongoing Clinical Trials

    Energy Technology Data Exchange (ETDEWEB)

    Di Maio, Massimo; Daniele, Gennaro; Piccirillo, Maria Carmela; Giordano, Pasqualina [Clinical Trials Unit, National Cancer Institute-“G. Pascale” Foundation, via Mariano Semmola, Napoli 80131 (Italy); Signoriello, Giuseppe [Medical Statistics, Second University, v. L. Armanni 5, Napoli 80138 (Italy); Daniele, Bruno [Medical Oncology Unit, “G.Rummo” Hospital, Benevento 82100 (Italy); Perrone, Francesco, E-mail: fr.perrone@agora.it [Clinical Trials Unit, National Cancer Institute-“G. Pascale” Foundation, via Mariano Semmola, Napoli 80131 (Italy)

    2012-06-05

    No systemic therapy had been proven effective in patients with advanced hepatocellular carcinoma (HCC) until 2007, when a large randomized trial with sorafenib demonstrated a clinically relevant prolongation of survival. Currently, sorafenib represents standard treatment for patients with advanced HCC and well-preserved liver function, whilst the evidence about its effectiveness in patients with more severe liver impairment is less robust. A randomized trial to demonstrate the efficacy of sorafenib in Child-Pugh B patients with advanced HCC is currently ongoing. In the meantime, several trials are testing the role of sorafenib in early HCC (as adjuvant treatment after potentially curative loco-regional therapies) and in intermediate stage (exploring different modalities of integration of sorafenib with trans-arterial chemo-embolization). The results of all these trials will better define the potentiality and the boundaries of use of sorafenib in HCC patients.

  6. Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses

    DEFF Research Database (Denmark)

    Brok, J.; Thorlund, K.; Gluud, C.;

    2008-01-01

    OBJECTIVES: To evaluate meta-analyses with trial sequential analysis (TSA). TSA adjusts for random error risk and provides the required number of participants (information size) in a meta-analysis. Meta-analyses not reaching information size are analyzed with trial sequential monitoring boundaries...... analogous to interim monitoring boundaries in a single trial. STUDY DESIGN AND SETTING: We applied TSA on meta-analyses performed in Cochrane Neonatal reviews. We calculated information sizes and monitoring boundaries with three different anticipated intervention effects of 30% relative risk reduction (TSA......(30%)), 15% (TSA(15%)), or a risk reduction suggested by low-bias risk trials of the meta-analysis corrected for heterogeneity (TSA(LBHIS)). RESULTS: A total of 174 meta-analyses were eligible; 79 out of 174 (45%) meta-analyses were statistically significant (P

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

    NARCIS (Netherlands)

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

    2010-01-01

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

  8. Rituximab versus cyclophosphamide in ANCA-associated renal vasculitis : 2-year results of a randomised trial

    NARCIS (Netherlands)

    Jones, Rachel B.; Furuta, Shunsuke; Tervaert, Jan Willem Cohen; Hauser, Thomas; Luqmani, Raashid; Morgan, Matthew D.; Peh, Chen Au; Savage, Caroline O.; Segelmark, Marten; Tesar, Vladimir; van Paassen, Pieter; Walsh, Michael; Westman, Kerstin; Jayne, David R. W.; Stegeman, C. A.

    2015-01-01

    Objectives The RITUXVAS trial reported similar remission induction rates and safety between rituximab and cyclophosphamide based regimens for antineutrophil cytoplasm antibody (ANCA)-associated vasculitis at 12months; however, immunosuppression maintenance requirements and longer-term outcomes after

  9. Modified intention-to-treat analysis did not bias trial results

    DEFF Research Database (Denmark)

    Dossing, Anna; Tarp, Simon; Furst, Daniel E;

    2016-01-01

    AND SETTING: Placebo-controlled, blinded randomized trials on biological or targeted interventions for rheumatoid arthritis were identified through a systematic search. Two authors independently extracted data. A random-effects meta-analysis was used to combine odds ratios as an expression of treatment effect....... This suggests that the mITT approach in rheumatoid arthritis trials investigating biological or targeted interventions does not introduce bias compared to ITT....

  10. A review of blood substitutes: examining the history, clinical trial results, and ethics of hemoglobin-based oxygen carriers

    Directory of Open Access Journals (Sweden)

    Jiin-Yu Chen

    2009-01-01

    Full Text Available The complications associated with acquiring and storing whole blood for transfusions have launched substantial efforts to develop a blood substitute. The history of these efforts involves a complicated mixture of science, ethics, and business. This review focuses on clinical trials of the three hemoglobin-based oxygen carriers (HBOC that have progressed to Phase II or III clinical trials: HemAssist (Baxter; Deerfield, IL, US, PolyHeme (Northfield; Evanston, IL, US, and Hemopure (Biopure; Cambridge, MA, US. Published animal studies and clinical trials carried out in a perioperative setting have demonstrated that these products successfully transport and deliver oxygen, but all may induce hypertension and lead to unexpectedly low cardiac outputs. Overall, these studies suggest that HBOCs resulted in only modest blood saving during and after surgery, no improvement in mortality and an increased incidence of adverse reactions. To date, the results from these perioperative studies have not led to regulatory approval. All three companies instead chose to focus their efforts on large trials of trauma patients in the pre-hospital setting. Baxter abandoned the development of HemAssist after a trial in the U.S. was prematurely halted when the first 100 patients showed significantly increased mortality rates as compared to patients treated with blood products. Northfield's PolyHeme trial demonstrated a non-significant trend towards increased mortality and a very modest reduction in the subsequent need for blood. The testing of Biopure's Hemopure for trauma patients has been halted for several years because of FDA concerns over trial design and study justification. Ethical concerns have also been raised regarding the design and implementation of all HBOC clinical trials. Thus, the available evidence suggests that HemAssist, Polyheme, and Hemopure are associated with a significant level of cardiovascular dysfunction. The next generation of HBOCs remains

  11. Radiotherapy for achillodynia. Results of a single-center prospective randomized dose-optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Jeremias, C.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2013-02-15

    Background and purpose: The aim of this study was to compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with achillodynia. Patients and methods: Between February 2006 and February 2010, 112 consecutive evaluable patients were recruited for this prospective randomized trial. All patients underwent radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions over 3 weeks. In case of insufficient remission of pain after 6 weeks, a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after radiotherapy with a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 84% directly after and 88% 6 weeks after radiotherapy. The mean VAS values before, directly after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 55.7 {+-} 21.0 and 58.2 {+-} 23.5 (p = 0.526), 38.0 {+-} 23.2 and 30.4 {+-} 22.6 (p = 0.076), and 35.4 {+-} 25.9 and 30.9 {+-} 25.4 (p = 0.521), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 8.2 {+-} 3.0 and 8.9 {+-} 3.3 (p = 0.239), 5.6 {+-} 3.1 and 5.4 {+-} 3.3 (p = 0.756), 4.4 {+-} 2.6 and 5.3 {+-} 3.8 (p = 0.577), respectively. No statistically significant differences were found between the two single-dose trial arms for early (p = 0.366) and delayed response (p = 0.287). Conclusion: Radiotherapy is an effective treatment option for the management of achillodynia. For radiation protection, the dose of a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  12. Benign painful elbow syndrome. First results of a single center prospective randomized radiotherapy dose optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2012-10-15

    Background and purpose: The goal of the present study was to evaluate the efficacy of two different dose-fractionation schedules for radiotherapy (RT) of patients with painful elbow syndrome. Patients and methods: Between February 2006 and February 2010, 199 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received RT in orthovoltage technique. One RT course consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after RT by a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 80% direct after and 91% 6 weeks after RT. The mean VAS values before, after and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 59.6 {+-} 20.2 and 55.7 {+-} 18.0 (p = 0.463), 32.1 {+-} 24.5 and 34.4 {+-} 22.5 (p = 0.256), and 27.0 {+-} 27.7 and 23.5 {+-} 21.6 (p = 0.818). The mean CPS before, after, and 6 weeks after treatment was 8.7 {+-} 2.9 and 8.1 {+-} 3.1 (p = 0.207), 4.5 {+-} 3.2 and 5.0 {+-} 3.4 (p = 0.507), 3.9 {+-} 3.6 and 2.8 {+-} 2.8 (p = 0.186), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.103) and delayed response (p = 0.246) were found. Conclusion: RT is an effective treatment option for the management of benign painful elbow syndrome. For radiation protection reasons the dose for a RT series is recommended not to exceed 3.0 Gy. (orig.)

  13. Levo-α-acetylmethadol (LAAM induced QTc-prolongation - results from a controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Wieneke H

    2009-01-01

    Full Text Available Abstract Background Due to potential proarrhythmic side-effects levo-α-Acetylmethadol (LAAM is currently not available in EU countries as maintenance drug in the treatment of opiate addiction. However, recent studies and meta-analyses underline the clinical advantages of LAAM with respect to the reduction of heroin use. Thus a reappraisal of LAAM has been demanded. The aim of the present study was to evaluate the relative impact of LAAM on QTc-interval, as a measure of pro-arrhythmic risk, in comparison to methadone, the current standard in substitution therapy. Methods ECG recordings were analysed within a randomized, controlled clinical trial evaluating the efficacy and tolerability of maintenance treatment with LAAM compared with racemic methadone. Recordings were done at two points: 1 during a run-in period with all patients on methadone and 2 24 weeks after randomisation into methadone or LAAM treatment group. These ECG recordings were analysed with respect to QTc-values and QTc-dispersion. Mean values as well as individual changes compared to baseline parameters were evaluated. QTc-intervals were classified according to CPMP-guidelines. Results Complete ECG data sets could be obtained in 53 patients (31 LAAM-group, 22 methadone-group. No clinical cardiac complications were observed in either group. After 24 weeks, patients receiving LAAM showed a significant increase in QTc-interval (0.409 s ± 0.022 s versus 0.418 s ± 0.028 s, p = 0.046, whereas no significant changes could be observed in patients remaining on methadone. There was no statistically significant change in QTc-dispersion in either group. More patients with borderline prolonged and prolonged QTc-intervals were observed in the LAAM than in the methadone treatment group (n = 7 vs. n = 1; p = 0.1. Conclusions In this controlled trial LAAM induced QTc-prolongation in a higher degree than methadone. Given reports of severe arrhythmic events, careful ECG-monitoring is recommended

  14. EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ceren Acarturk

    2015-05-01

    Full Text Available Background: The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD. Eye movement desensitization and reprocessing (EMDR is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT has been published on treating PTSD symptoms in a refugee camp population. Objective: Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method: Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15 or wait-list control (n=14. The main outcome measures were Impact of Event Scale-Revised (IES-R and Beck Depression Inventory (BDI-II at posttreatment and 4-week follow-up. Results: Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64. The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92. Conclusion: The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost- effectiveness of EMDR in similar populations are needed.

  15. Routine assessment of psychosocial problems after cancer genetic counseling: results from a randomized controlled trial.

    Science.gov (United States)

    Eijzenga, W; Bleiker, E M A; Ausems, M G E M; Sidharta, G N; Van der Kolk, L E; Velthuizen, M E; Hahn, D E E; Aaronson, N K

    2015-05-01

    Approximately 70% of counselees undergoing cancer genetic counseling and testing (CGCT) experience some degree of CGCT-related psychosocial problems. We evaluated the efficacy of an intervention designed to increase detection and management of problems 4 weeks after completion of CGCT. In this randomized, controlled trial, 118 participants completed a CGCT-related problem questionnaire prior to an - audiotaped - telephone session with their counselor 1 month after DNA-test disclosure. For those randomized to the intervention group (n = 63), a summary of the questionnaire results was provided to the counselor prior to the telephone session. Primary outcomes were discussion of the problems, counselors' awareness of problems, and problem management. Secondary outcomes included self-reported distress, cancer worries, CGCT-related problems, and satisfaction. Counselors who received a summary of the questionnaire were more aware of counselees' problems in only one psychosocial domain (practical issues). No significant differences in the number of problems discussed, in problem management, or on any of the secondary outcomes were observed. The prevalence of problems was generally low. The telephone session, combined with feedback on psychosocial problems, has minimal impact. The low prevalence of psychosocial problems 1 month post-CGCT recommends against its use as a routine extension of the CGCT procedure. PMID:25130962

  16. Pro-inflammatory cytokines and psychotherapy in depression: Results from a randomized clinical trial.

    Science.gov (United States)

    Del Grande da Silva, Giovanna; Wiener, Carolina David; Barbosa, Luana Porto; Gonçalves Araujo, Jaciana Marlova; Molina, Mariane Lopez; San Martin, Pedro; Oses, Jean Pierre; Jansen, Karen; Dias de Mattos Souza, Luciano; Azevedo da Silva, Ricardo

    2016-04-01

    Depression is a serious condition that is associated with great psychic suffering and major impairments on the patient's general health, quality of life, and social and occupational activities. In some cases, it may lead to suicide. Regardless of the innumerous research works that have already addressed depression in wide and specific facets, there is still a lot to grasp in order to effectively help preventing and treating depression. This work presents data from a randomized clinical trial that sought to evaluate the effectiveness of two brief psychotherapeutic for Depression: Cognitive Behavioral Therapy (CBT) and Supportive-Expressive Dynamic Psychotherapy (SEDP). This was a convenience sample composed of 46 individuals that were evaluated using a structured diagnostic interview and then randomly allocated to the SEDP group. We examined baseline and post-intervention serum levels of the Interleukin-6 (IL-6) and the Tumor Necrosis Factor (TNF-α) in addition to the severity of depressive symptoms according to the Outcome Questionnaire - 45.2 (OQ-45.2) and the Beck Depression Inventory (BDI). Results show that serum IL-6 and TNF-α levels, as well as the scores from the OQ-45.2 and the BDI significantly decreased after 16 sessions of SEDP (p brief psychodynamic psychotherapy in the reduction of depressive symptoms and serum inflammatory levels that are associated with depression. PMID:26802811

  17. SAFARI - RANDOMISED TRIAL ON COMPLEX THERAPY OF ARTERIAL HYPERTENSION AND DISLIPIDEMY. THE MAIN RESULTS

    Directory of Open Access Journals (Sweden)

    S. Y. Martsevich

    2016-01-01

    Full Text Available Aim. To evaluate possibility of complex pharmaceutical effect simultaneously on 2 risk factors – arterial hypertension (HT and hypercholesterolemia (HH in patients with high risk of cardiovascular complications (CVC.Material and methods. 101 patients with HT of 1-2 stage, HH and high risk of CVC (SCORE>5 were included in the study. Patients were randomized in 2 groups: active therapy group (ATG and control group (CG. ATG patients were actively treated for HT and HH control. The long-acting nifedipine (Nifecard XL, LEK 30 mg once daily (OD was prescribed as start antihypertensive drug. Hydrochlorothiazide 12,5 mg/day OD and bisiprolol 5 mg OD was added if antihypertensive effect was insufficient. Atorvastatin (Tulip, LEK 20-40 mg OD was prescribed for HH control. Management of CG patients was performed by doctors of out-patient clinics. The study duration was 12 weeks.Results. Systolic and diastolic blood pressure (BP levels in ATG patients were lower than these in CG patients. Target BP level was reached in 88,4% of ATG patients and only in 48,9% of CG patients. Cholesterol of low density lipoprotein (CH LPLD level was also lower in ATG patients than this in CG patients. Target CH LPLD level was reached in 37,2 % of ATG patients and in 8,3 % of CG patients. Relative risk of CVC was significantly lower in ATG patients than this in CG patients.Conclusion. SAFARI trial shows that effective pharmaceutical simultaneous control of 2 key risk factors, HT and HH, results in risk reduction of CVC.

  18. Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey

    Directory of Open Access Journals (Sweden)

    Houston Helen

    2010-12-01

    Full Text Available Abstract Background Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. This study aims to determine participants' preferences for type of leaflet (short versus long used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants' preferences. Methods 553 participants in a randomised trial about General Practitioners' access to Magnetic Resonance Imaging for patients presenting with suspected internal derangement of the knee were asked in the final follow-up questionnaire whether they would like to be fed back the results of the trial. Participants who agreed to this were included in a postal questionnaire survey asking about their preference, if any, between a short and a long leaflet and what it was about the leaflet that they preferred. Multinomial logistic regression was used to test whether certain demographics of responding participants along with treatment group explained whether a participant had a preference for type of leaflet or no preference. Results Of the participants who returned the final follow-up questionnaire, 416 (88% agreed to receive the results of the trial. Subsequently 132 (32% participants responded to the survey. Most participants preferred the longer leaflet (55% and the main reasons for this were the use of technical information (94% and diagrams (89%. There was weak evidence to suggest that gender might explain whether participants have a preference for type of leaflet or not (P = 0.084. Conclusions Trial participants want to receive feed back about the results and appear to prefer a longer leaflet. Males and females might require information to be communicated to them differently and should

  19. A randomised controlled trial of forward-planned radiotherapy (IMRT) for early breast cancer: Baseline characteristics and dosimetry results

    International Nuclear Information System (INIS)

    Background and purpose: This large trial was designed to investigate whether correction of dose inhomogeneities using intensity-modulated radiotherapy (IMRT) reduces late toxicity and improves quality of life in patients with early breast cancer. This paper reports baseline characteristics of trial participants and dosimetry results. Materials and methods: Standard tangential plans of 1145 trials were analysed. Patients with inhomogeneous plans, defined by ICRU recommendations, were randomised to forward-planned IMRT or standard radiotherapy. Results: Twenty-nine percentage of patients had adequate dosimetry with standard 2D radiotherapy. In the randomised patients, the decreases in mean volumes receiving greater than 107% (Vol > 107) and less than 95% (Vol 3 (95% CI 26.4-41.6; P 3 (95% CI 34.4-61.9; P 107 > 2 cm3 on standard radiotherapy plans. Conclusion: This large trial, in which patients with all breast sizes were eligible, confirmed that breast dosimetry can be significantly improved with a simple method of forward-planned IMRT and has little impact on radiotherapy resources. It is shown that patients with larger breasts are more likely to have dose inhomogeneities and breast separation gives some indication of this likelihood. Photographic assessment of patients at 2 years after radiotherapy, as the next part of this randomised controlled trial, will show whether these results for IMRT translate into improved cosmetic outcome in patients with early breast cancer. This would provide impetus for the widespread adoption of 3D planning and IMRT.

  20. Interpreting trial results following use of different intention-to-treat approaches for preventing attrition bias

    DEFF Research Database (Denmark)

    Dossing, Anna; Tarp, Simon; Furst, Daniel E;

    2014-01-01

    concerns when executing different mITT approaches in meta-analyses. METHODS AND ANALYSIS: Using meta-epidemiology on randomised trials considered less prone to bias (ie, good internal validity) and assessing biological or targeted agents in patients with rheumatoid arthritis, we will meta-analyse data from...... 10 biological and targeted drugs based on collections of trials that would correspond to 10 individual meta-analyses. ETHICS AND DISSEMINATION: This study will enhance transparency for evaluating mITT treatment effects described in meta-analyses. The intended audience will include healthcare...

  1. Albuminuria and tolvaptan in autosomal-dominant polycystic kidney disease : results of the TEMPO 3:4 Trial

    NARCIS (Netherlands)

    Gansevoort, Ron T; Meijer, Esther; Chapman, Arlene B; Czerwiec, Frank S; Devuyst, Olivier; Grantham, Jared J; Higashihara, Eiji; Krasa, Holly B; Ouyang, John; Perrone, Ronald D; Torres, Vicente E

    2015-01-01

    BACKGROUND: The TEMPO 3:4 Trial results suggested that tolvaptan had no effect compared with placebo on albuminuria in autosomal-dominant polycystic kidney disease (ADPKD) patients. However, the use of categorical 'albuminuria events' may have resulted in a loss of sensitivity to detect changes. The

  2. Treatment of Accommodative Dysfunction in Children: Results from an Random Clinical Trial

    Science.gov (United States)

    Scheiman, Mitchell; Cotter, Susan; Kulp, Marjean Taylor; Mitchell, G. Lynn; Cooper, Jeffrey; Gallaway, Michael; Hopkins, Kristine B.; Bartuccio, Mary; Chung, Ida

    2011-01-01

    Purpose To report the effectiveness of various forms of vision therapy/orthoptics in improving accommodative amplitude and facility in children with symptomatic convergence insufficiency (CI) and co-existing accommodative dysfunction. Methods In a randomized clinical trial, 221 children 9 to 17 years with symptomatic CI were assigned to one of four treatments. Of the enrolled children, 164 (74%) had accommodative dysfunction; 63 (29%) had a decreased amplitude of accommodation with respect to age, 43 (19%) had decreased accommodative facility, and 58 (26%) had both. Analysis of variance models were used to compare mean accommodative amplitude and accommodative facility for each treatment group after 4, 8, and 12 weeks of treatment. Results After 12 weeks of treatment, the increases in amplitude of accommodation [office-based vergence/accommodative therapy with home reinforcement group (OBVAT) 9.9D, home-based computer vergence/accommodative therapy group (HBCVAT+) 6.7D, home-based pencil push-up therapy group (HBPP) 5.8D] were significantly greater than in the office-based placebo therapy group (2.2D) (p-values ≤ 0.010). Significant increases in accommodative facility were found in all groups (OBVAT: 9cpm, HBCVAT+: 7cpm, HBPP: 5cpm, OBPT: 5.5cpm); only the improvement in the OBVAT group was significantly greater than that found in the OBPT group (p = 0.016). One year after completion of therapy, reoccurrence of decreased accommodative amplitude was present in only 12.5% and accommodative facility in only 11%. Conclusions Vision therapy/orthoptics is effective in improving accommodative amplitude and accommodative facility in school-age children with symptomatic CI and accommodative dysfunction. PMID:21873922

  3. Effectiveness of cellulose sulfate vaginal gel for the prevention of HIV infection: results of a Phase III trial in Nigeria.

    Directory of Open Access Journals (Sweden)

    Vera Halpern

    Full Text Available BACKGROUND: This trial evaluated the safety and effectiveness of 6% cellulose sulfate vaginal gel in preventing male-to-female vaginal transmission of HIV, gonorrhea and chlamydial infection. METHODS: This Phase III, double-blind, randomized, placebo-controlled trial was conducted between November 2004 and March 2007 in Lagos and Port Harcourt, Nigeria. We enrolled 1644 HIV-antibody negative women at high risk of HIV acquisition. Study participants were randomized 1:1 to cellulose sulfate or placebo and asked to use gel plus a condom for each act of vaginal intercourse over one year of follow-up. The participants were evaluated monthly for HIV, gonorrhea and chlamydial infection, and for adverse events. RESULTS: The trial was stopped prematurely after the data safety monitoring board of a parallel trial concluded that cellulose sulfate might be increasing the risk of HIV. In contrast, we observed fewer infections in the active arm (10 than on placebo (13, a difference that was nonetheless not statistically significant (HR = 0.8, 95% CI 0.3-1.8; p = 0.56. Rates of gonorrhea and chlamydial infection were lower in the CS group but the difference was likewise not statistically significant (HR = 0.8, 95% CI 0.5-1.1; p = 0.19 for the combined STI outcome. Rates of adverse events were similar across study arms. No serious adverse events related to cellulose sulfate use were reported. CONCLUSIONS: Cellulose sulfate gel appeared to be safe in the evaluated study population but we found insufficient evidence that it prevented male-to-female vaginal transmission of HIV, gonorrhea or chlamydial infection. The early closure of the trial compromised the ability to draw definitive conclusions about the effectiveness of cellulose sulfate against HIV. TRIAL REGISTRATION: ClinicalTrials.gov NCT00120770.

  4. Efficacy of the "Responsive Classroom" Approach: Results from a 3-Year, Longitudinal Randomized Controlled Trial

    Science.gov (United States)

    Rimm-Kaufman, Sara E.; Larsen, Ross A. A.; Baroody, Alison E.; Curby, Timothy W.; Ko, Michelle; Thomas, Julia B.; Merritt, Eileen G.; Abry, Tashia; DeCoster, Jamie

    2014-01-01

    This randomized controlled field trial examined the efficacy of the Responsive Classroom (RC) approach on student achievement. Schools (n = 24) were randomized into intervention and control conditions; 2,904 children were studied from end of second to fifth grade. Students at schools assigned to the RC condition did not outperform students at…

  5. Mainstreaming Remedial Mathematics Students in Introductory Statistics: Results Using a Randomized Controlled Trial

    Science.gov (United States)

    Logue, Alexandra W.; Watanabe-Rose, Mari

    2014-01-01

    This study used a randomized controlled trial to determine whether students, assessed by their community colleges as needing an elementary algebra (remedial) mathematics course, could instead succeed at least as well in a college-level, credit-bearing introductory statistics course with extra support (a weekly workshop). Researchers randomly…

  6. Genetic susceptibility testing and readiness to control weight: Results from a randomized controlled trial

    NARCIS (Netherlands)

    Meisel, S.F.; Beeken, R.J.; Jaarsveld, C.H.M. van; Wardle, J.

    2015-01-01

    OBJECTIVE: To test the hypothesis that adding obesity gene feedback (FTO) to simple weight control advice at a life stage with raised risk of weight gain (university) increases readiness to control weight. METHODS: Individually randomized controlled trial comparing the effect of: (i) simple weight c

  7. Cancer Screening Knowledge Changes: Results from a Randomized Control Trial of Women with Developmental Disabilities

    Science.gov (United States)

    Parish, Susan L.; Rose, Roderick A.; Luken, Karen; Swaine, Jamie G.; O'Hare, Lindsey

    2012-01-01

    Background: Women with developmental disabilities are much less likely than nondisabled women to receive cervical and breast cancer screening according to clinical guidelines. One barrier to receipt of screenings is a lack of knowledge about preventive screenings. Method: To address this barrier, we used a randomized control trial (n = 175 women)…

  8. Youth Can! Results of a Pilot Trial to Improve the School Food Environment

    Science.gov (United States)

    Jones, Sonya; Spence, Marsha; Hardin, Sonia; Clemente, Nicolle; Schoch, Ashlee

    2011-01-01

    Objective: This study evaluated the potential of youth partnerships to improve the school environment and child nutrition. Methods: A quasi-experimental trial was conducted with 2 intervention and 3 control schools. Intervention schools selected student leaders to participate in youth-led interventions in their schools. Students (n = 104) were…

  9. Quality of life endovascular and open AAA repair. Results of a randomised trial.

    NARCIS (Netherlands)

    Prinssen, M.; Buskens, E.; Blankensteijn, J.D.

    2004-01-01

    AIM: To compare the quality of life (QoL) in the first postoperative year after elective endovascular abdominal aortic aneurysm repair (EVAR) and open repair (OR) in a randomised study. METHODS: In the Dutch Randomised Endovascular Aneurysm Management (DREAM) trial, patients are randomly allocated t

  10. Sexual Dysfunction After Conventional and Endovascular AAA Repair: Results of the DREAM Trial.

    NARCIS (Netherlands)

    Prinssen, M.; Buskens, E.; Nolthenius, R.P.T.; Sterkenburg, S. van; Teijink, J.A.; Blankensteijn, J.D.

    2004-01-01

    Purpose: To assess sexual function in the first postoperative year after elective endovascular aneurysm repair (EVAR) and open repair (OR) of abdominal aortic aneurysm (AAA).Methods: In the Dutch Randomized Endovascular Aneurysm Management (DREAM) trial, 153 patients (141 men; mean age 71 years, ran

  11. The effectiveness of integrated care for patients with hand eczema: Results of a randomized, controlled trial

    NARCIS (Netherlands)

    Gils, R.F. van; Boot, C.R.L.; Knol, D.L.; Rustemeyer, T.; Mechelen, W. van; Valk, P.G.M. van der; Anema, J.R.

    2012-01-01

    Objectives. To evaluate the effectiveness of integrated, multidisciplinary care as compared with usual care for patients with moderate to severe, chronic hand eczema after 26 weeks of follow-up. Background. This study was designed as a randomized, controlled trial. Methods. Patients who visited one

  12. Variability of Spirometry in Chronic Obstructive Pulmonary Disease: Results from Two Clinical Trials

    OpenAIRE

    Herpel, Laura B.; Kanner, Richard E.; Lee, Shing M.; Fessler, Henry E.; Sciurba, Frank C.; Connett, John E.; Wise, Robert A.

    2006-01-01

    Objective: Our goal is to determine short-term intraindividual biologic and measurement variability in spirometry of patients with a wide range of stable chronic obstructive pulmonary disease severity, using datasets from the National Emphysema Treatment Trial (NETT) and the Lung Health Study (LHS). This may be applied to determine criteria that can be used to assess a clinically meaningful change in spirometry.

  13. Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) trial

    NARCIS (Netherlands)

    D.R. Holmes Jr (David); J.R. Granett (Jeffrey); J.J. Popma (Jeffrey); P.J. Fitzgerald (Peter); D. Fischman (David); J.J. Ferguson (James); A.M. Lincoff (Michael); S. Goldberg (Sheldon); J.A. Brinker; R. Chan; B.R. Davis (Barry); M. Poland; A.M. Zeiher (Andreas); J.T. Willerson (James); S.B. King 3rd (Spencer); L.M. Shapiro; M. Savage (Michael); J.M. Lablanche (Jean Marc); J.E. Tcheng (James); L. Grip (Lars); P.W.J.C. Serruys (Patrick)

    2002-01-01

    textabstractBACKGROUND: Restenosis after percutaneous coronary intervention (PCI) is a major problem affecting 15% to 30% of patients after stent placement. No oral agent has shown a beneficial effect on restenosis or on associated major adverse cardiovascular events. In limited trials, the oral age

  14. Enhancing Attachment Organization among Maltreated Children: Results of a Randomized Clinical Trial

    Science.gov (United States)

    Bernard, Kristin; Dozier, Mary; Bick, Johanna; Lewis-Morrarty, Erin; Lindhiem, Oliver; Carlson, Elizabeth

    2012-01-01

    Young children who have experienced early adversity are at risk for developing disorganized attachments. The efficacy of Attachment and Biobehavioral Catch-up (ABC), an intervention targeting nurturing care among parents identified as being at risk for neglecting their young children, was evaluated through a randomized clinical trial. Attachment…

  15. Publication Trend of Clinical Trials with Negative Results Funded by Pharmaceutical Industries for the 2007-2012 Period

    Directory of Open Access Journals (Sweden)

    Evert A. Jiménez-Cotes

    2015-01-01

    Full Text Available Abstract: Objective: To evaluate the results of clinical trials financed by the pharmaceutical industries during the period 2007-2012 in a general medical journal. Materials and methods: We performed an observational cross sectional study where originals clinical trials financed by the pharmaceutical industry published between 2007 and 2012 in the journal The New England Journal of Medicine (http://www.nejm.org were reviewed. Trend Chi2 test was used to evaluate the results of studies over the years. A database was created with different variables, identifying the number of publications and the period of greater publishing negatives studies, as well as the medical specialty and pharmaceutical industry funding. Results: 321 clinical trials were analyzed. The Odds Ratio was calculated for each year evaluated, finding a Chi2 of linear trend in negatives studies of 2.91 with value p 0.08 and positive studies of 1.16 with value p 0.28. It was found that in the period 2007-2009 123 studies were published, 40 % of which presented negative results; unlike the 2010-2012 period in which 198 clinical trials where published, 142 of them, showed positive results, OR 1.68, 95 % CI (1.02-2.78 value p 0.03. The highest figures of negative results were published in 2007: 44.7 %. Conclusions: A progressive decrease in the number of publications with annual general negative results has been observed. A statistically significant difference in the publication of negative studies per year was not found between the periods 2007-2012. The medical specialty that showed the largest number of total and negative publications in both periods was cardiology. The pharmaceutical industry that sponsored most total clinical trials with negative results in both periods did so through Merck, Glaxo SmithKline, and Sanofi-Aventis. 50% of neurology publications showed negative results.

  16. Confirmation of the protective effect of Ascaris lumbricoides on Plasmodium falciparum infection: results of a randomized trial in Madagascar.

    Science.gov (United States)

    Brutus, Laurent; Watier, Laurence; Hanitrasoamampionona, Virginie; Razanatsoarilala, Hélène; Cot, Michel

    2007-12-01

    A controlled randomized trial of anti-helminthic treatment was undertaken in 1996-1997 in a rural area of Madagascar where populations were simultaneously infected with Ascaris lumbricoides, Plasmodium falciparum, and Schistosoma mansoni. Levamisole was administered bimonthly to 107 subjects, whereas 105 were controls. Levamisole was highly effective in reducing Ascaris egg loads in the treated group (P 15 years of age. This study confirms the results of a randomized trial, which showed a negative interaction in those > 5 years of age between Ascaris and malaria parasite density in another Malagasy population, submitted to a higher malaria transmission.

  17. Dutch iliac stent trial : Long-term results in patients randomized for primary or selective stent placement

    NARCIS (Netherlands)

    Klein, W.M.; van der Graaf, Y.; Seegers, J.; Spithoven, J.H.; Buskens, E.; van Baal, J.G.; Buth, J.; Moll, F.L.; Overtoom, T.T.C.; van Sambeek, M.R.H.M.; Mali, W.P.T.M.

    2006-01-01

    Purpose: To determine long-term results of the prospective Dutch Iliac Stent Trial. Materials and Methods: The study protocol was approved by local institutional review boards. All patients gave written informed consent. Two hundred seventy-nine patients (201 men, 78 women; mean age, 58 years) with

  18. Efficacy of metronidazole versus placebo in pain control after hemorrhoidectomy: results of a controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Sergio Solorio-López

    2015-11-01

    Full Text Available Introduction: Hemorrhoidal disease occurs in 50% of people aged > 40 years and is the most common reason for anorectal surgery. Pain is the main complication. Multiple topical and systemic drugs have been investigated for pain control, but there is no ideal treatment. Metronidazole has been shown to decrease postoperative pain but is not used widely. Objective: To evaluate the effect of oral metronidazole versus placebo and to assess postoperative pain following hemorrhoidectomy. Material and methods: Controlled clinical trial in adult patients who underwent elective hemorrhoidectomy for grade III/IV hemorrhoids. Patients were assigned to receive metronidazole (500 mg q8 h orally; study group, SG or placebo (control group, CG for 7 days after surgery. Pain was assessed using a visual analog scale after surgery. Analgesic administration (time and use of analgesics and resumption of daily life activities were also assessed. Results: Forty-four patients were included, 22 in each group. Postoperative pain differed significantly between the SG and CG at 6 h (3.86 ± 0.56, 6.64 ± 1.49, 12 h (5.59 ± 1.33, 8.82 ± 0.79, 24 h (6.86 ± 1.49, 9.73 ± 0.45, day 4 (5.32 ± 2.10, 9.50 ± 0.59, day 7 (3.14 ± 1.03, 7.36 ± 1.39, and day 14 (2.14 ± 0.46, 5.45 ± 1.29. The first analgesia dose was required at 21.27 ± 5.47 h in the CG and 7.09 ± 2.36 h in the SG (p < 0.05, the time of analgesic use was 6.86 ± 1.61 days in the CG and 13.09 ± 2.48 days in the SG (p < 0.05, and resumption of daily activities occurred at 7.59 ± 1.56 days in the CG and 14.73 ± 3.76 days in the SG (p < 0.05. Conclusion: Oral administration of metronidazole is effective in pain management after hemorrhoidectomy.

  19. Towards a rational screening strategy for albuminuria: results from the unreferred renal insufficiency trial.

    Directory of Open Access Journals (Sweden)

    Arjan van der Tol

    Full Text Available BACKGROUND: There remains debate about the screening strategies for albuminuria. This study evaluated whether a screening strategy in an apparently healthy population based on basic clinical and biochemical parameters could be more effective than a strategy where screening for albuminuria is performed unselectively. METHODOLOGY/PRINCIPAL FINDINGS: The Unreferred Renal Insufficiency (URI Study is a cross-sectional study on the prevalence of metabolic risk factors in Belgian workers, volunteering to be screened during a routine yearly occupational check-up. Subjects (n = 295 with treated hypertension, known diabetes, treated dyslipidaemia, cardiovascular and renal disease were excluded. Among 1,191 apparently healthy subjects, 23% had unknown hypertension, 13% had impaired glucose tolerance, 15.4% had normoalbuminuria, 4.2% had microalbuminuria and 0.4% had macroalbuminuria. Subjects with resting heart rate ≥85 bpm, plasma glucose ≥5.6 mmol/L and blood pressure ≥140/90 mmHg were associated with albuminuria of any degree. A strategy where only subjects with at least one of these risk factors (n = 431 were screened for albuminuria, would identify all subjects with macroalbuminuria (5/5, 64% of those with microalbuminuria (32/50, and less than half of those with normoalbuminuria (81/183. An alternative strategy whereby subjects were first screened for presence of albuminuria, and additional cardiovascular risk factors were only measured in subjects positive for albuminuria (n = 238, would identify only 27% (118/431 of the subjects with additional and potentially modifiable cardiovascular risk factors. On the other hand, half of the subjects in this study with albuminuria (120/238, of which 102 had normoalbuminuria, had no additional cardiovascular risk factor at all. CONCLUSIONS: Screening an apparently healthy population directly for albuminuria will result in a high percentage of false positives, mostly measured in the normal

  20. Long-Term Results From the Contura Multilumen Balloon Breast Brachytherapy Catheter Phase 4 Registry Trial

    Energy Technology Data Exchange (ETDEWEB)

    Cuttino, Laurie W., E-mail: lcuttino@mcvh-vcu.edu [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States); Arthur, Douglas W. [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States); Vicini, Frank [Michigan Healthcare Professionals/21st Century Onoclogy, Farmington Hills, Michigan (United States); Todor, Dorin [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States); Julian, Thomas [Allegheny Hospital, Temple School of Medicine, Pittsburgh, Pennsylvania (United States); Mukhopadhyay, Nitai [Department of Radiation Oncology, Virginia Commonwealth University, Richmond, Virginia (United States)

    2014-12-01

    Purpose: To describe the long-term outcomes from a completed, multi-institutional phase 4 registry trial using the Contura multilumen balloon (CMLB) breast brachytherapy catheter to deliver accelerated partial breast irradiation (APBI) in patients with early-stage breast cancer. Methods and Materials: Three hundred forty-two evaluable patients were enrolled by 23 institutions between January 2008 and February 2011. All patients received 34 Gy in 10 fractions, delivered twice daily. Rigorous target coverage and normal tissue dose constraints were observed. Results: The median follow-up time was 36 months (range, 1-54 months). For the entire patient cohort of 342 patients, 10 patients experienced an ipsilateral breast tumor recurrence (IBTR). Eight of these IBTR were classified as true recurrences/marginal miss (TRMM), and 2 were elsewhere failures (EF). Local recurrence-free survival was 97.8% at 3 years. For the entire cohort, 88% of patients had good to excellent overall cosmesis. The overall incidence of infection was 8.5%. Symptomatic seroma was reported in only 4.4% of patients. A separate analysis was performed to determine whether improved outcomes would be observed for patients treated at high-volume centers with extensive brachytherapy experience. Three IBTR were observed in this cohort, only 1 of which was classified as a TRMM. Local recurrence-free survival at high-volume centers was 98.1% at 3 years. Overall cosmetic outcome and toxicity were superior in patients treated at high-volume centers. In these patients, 95% had good to excellent overall cosmesis. Infection was observed in only 2.9% of patients, and symptomatic seroma was reported in only 1.9%. Conclusion: Use of the CMLB for APBI delivery is associated with acceptable long-term local control and toxicity. Local recurrence-free survival was 97.8% at 3 years. Significant (grade 3) toxicity was uncommon, and no grade 4 toxicity was observed. Treatment at high-volume centers was associated

  1. Results of the Ticlid or Plavix Post-Stents (TOPPS) trial: do they justify the switch from ticlopidine to clopidogrel after coronary stent placement?

    Science.gov (United States)

    Berger, Peter B

    2000-01-01

    In the Ticlid or Plavix Post-Stents (TOPPS) trial, 1016 patients undergoing successful coronary stent placement were randomized to receive aspirin and either ticlopidine or clopidogrel. In this trial, the dosages and regimens of ticlopidine and clopidogrel resembled more closely those used in most catheterization laboratories than did the two previous randomized trials comparing ticlopidine and clopidogrel. The results of the TOPPS trial support the current practice of substituting ticlopidine for clopidogrel in stent patients.

  2. Results of the Ticlid or Plavix Post-Stents (TOPPS trial: do they justify the switch from ticlopidine to clopidogrel after coronary stent placement?

    Directory of Open Access Journals (Sweden)

    Berger Peter B

    2000-10-01

    Full Text Available Abstract In the Ticlid or Plavix Post-Stents (TOPPS trial, 1016 patients undergoing successful coronary stent placement were randomized to receive aspirin and either ticlopidine or clopidogrel. In this trial, the dosages and regimens of ticlopidine and clopidogrel resembled more closely those used in most catheterization laboratories than did the two previous randomized trials comparing ticlopidine and clopidogrel. The results of the TOPPS trial support the current practice of substituting ticlopidine for clopidogrel in stent patients.

  3. A theory-based online health behaviour intervention for new university students (U@Uni:LifeGuide): results from a repeat randomized controlled trial

    OpenAIRE

    Cameron, David; Epton, Tracy; Norman, Paul; Sheeran, Paschal; Harris, Peter R; Webb, Thomas L.; Julious, Steven A.; Brennan, Alan; Thomas, Chloe; Petroczi, Andrea; Naughton, Declan; Shah, Iltaf

    2015-01-01

    Background This paper reports the results of a repeat trial assessing the effectiveness of an online theory-based intervention to promote healthy lifestyle behaviours in new university students. The original trial found that the intervention reduced the number of smokers at 6-month follow-up compared with the control condition, but had non-significant effects on the other targeted health behaviours. However, the original trial suffered from low levels of engagement, which the repeat trial sou...

  4. EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

    OpenAIRE

    Ceren Acarturk; Emre Konuk; Mustafa Cetinkaya; Ibrahim Senay; Marit Sijbrandij; Pim Cuijpers; Tamer Aker

    2015-01-01

    Background: The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT) has been published on treating PTSD symptoms in a refugee camp population. Objective: Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method: Twenty-...

  5. EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

    OpenAIRE

    Acarturk, Ceren; Konuk, Emre; Cetinkaya, Mustafa; Senay, Ibrahim; Sijbrandij, Marit; Cuijpers, Pim; Aker, Tamer

    2015-01-01

    Background: The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT) has been published on treating PTSD symptoms in a refugee camp population.Objective: Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees.Method: Twenty-ni...

  6. Correlates of Protection against Influenza in the Elderly: Results from an Influenza Vaccine Efficacy Trial

    OpenAIRE

    Dunning, Andrew J; Carlos A. DiazGranados; Voloshen, Timothy; Hu, Branda; Landolfi, Victoria A.; Talbot, H Keipp

    2016-01-01

    Although a number of studies have investigated and quantified immune correlates of protection against influenza in adults and children, data on immune protection in the elderly are sparse. A recent vaccine efficacy trial comparing standard-dose with high-dose inactivated influenza vaccine in persons 65 years of age and older provided the opportunity to examine the relationship between values of three immunologic assays and protection against community-acquired A/H3N2 influenza illness. The hi...

  7. Oral Doxycycline Reduces Pterygium Lesions; Results from a Double Blind, Randomized, Placebo Controlled Clinical Trial

    OpenAIRE

    Oscar Rúa; Larráyoz, Ignacio M; Barajas, María T.; Sara Velilla; Alfredo Martínez

    2012-01-01

    PURPOSE: To determine whether oral doxycycline treatment reduces pterygium lesions. DESIGN: Double blind, randomized, placebo controlled clinical trial. PARTICIPANTS: 98 adult patients with primary pterygium. METHODS: Patients were randomly assigned to receive 100 mg oral doxycycline twice a day (49 subjects), or placebo (49 subjects), for 30 days. Photographs of the lesion were taken at the time of recruitment and at the end of the treatment. Follow-up sessions were performed 6 and 12 months...

  8. Finasteride Concentrations and Prostate Cancer Risk: Results from the Prostate Cancer Prevention Trial

    OpenAIRE

    Chau, Cindy H.; Price, Douglas K.; Cathee Till; Goodman, Phyllis J.; Xiaohong Chen; Leach, Robin J; Johnson-Pais, Teresa L.; Hsing, Ann W.; Ashraful Hoque; Tangen, Catherine M.; Lisa Chu; Parnes, Howard L.; Schenk, Jeannette M.; Reichardt, Juergen K. V.; Thompson, Ian M

    2015-01-01

    Objective In the Prostate Cancer Prevention Trial (PCPT), finasteride reduced the risk of prostate cancer by 25%, even though high-grade prostate cancer was more common in the finasteride group. However, it remains to be determined whether finasteride concentrations may affect prostate cancer risk. In this study, we examined the association between serum finasteride concentrations and the risk of prostate cancer in the treatment arm of the PCPT and determined factors involved in modifying dru...

  9. Serum Phospholipid Fatty Acids and Prostate Cancer Risk: Results From the Prostate Cancer Prevention Trial

    OpenAIRE

    Brasky, Theodore M.; Till, Cathee; White, Emily; Neuhouser, Marian L; Song, Xiaoling; Goodman, Phyllis; Thompson, Ian M; King, Irena B.; Albanes, Demetrius; Kristal, Alan R.

    2011-01-01

    Inflammation may be involved in prostate cancer development and progression. This study examined the associations between inflammation-related phospholipid fatty acids and the 7-year-period prevalence of prostate cancer in a nested case-control analysis of participants, aged 55–84 years, in the Prostate Cancer Prevention Trial during 1994–2003. Cases (n = 1,658) were frequency matched to controls (n = 1,803) on age, treatment, and prostate cancer family history. Phospholipid fatty acids were ...

  10. Acupuncture is a feasible treatment for post-thoracotomy pain: results of a prospective pilot trial

    OpenAIRE

    Malhotra Vivek T; Rusch Valerie W; Vickers Andrew J; Downey Robert J; Cassileth Barrie R

    2006-01-01

    Abstract Background Thoracotomy is associated with severe pain that may persist for years. Acupuncture is a complementary therapy with a proven role in pain control. A randomized trial showed that acupuncture was effective in controlling pain after abdominal surgery, but the efficacy of this technique for the treatment of thoracotomy pain has not been established. We developed a novel technique for convenient application of acupuncture to patients undergoing thoracotomy, and in a Phase II tri...

  11. Genetic susceptibility testing and readiness to control weight: results from a randomized controlled trial

    OpenAIRE

    S. Meisel; Beeken, R. J.; van Jaarsveld, C H M; Wardle, J

    2015-01-01

    Objective To test the hypothesis that adding obesity gene feedback (FTO) to simple weight control advice at a life stage with raised risk of weight gain (university) increases readiness to control weight. Methods Individually randomized controlled trial comparing the effect of: (i) simple weight control advice plus FTO feedback (FA) and (ii) simple weight control advice only (AO) on readiness to engage with weight control. Differences in stage of change by genotype and differential weight con...

  12. The effect of the synthetic retinoid etretinate on sputum cytology: results from a randomised trial.

    OpenAIRE

    Arnold, A.M.; Browman, G.P.; Levine, M. N.; D'Souza, T.; Johnstone, B.; Skingley, P.; Turner-Smith, L.; Cayco, R.; Booker, L.; Newhouse, M

    1992-01-01

    Laboratory studies, and one previous uncontrolled trial, have suggested that retinoids may reverse bronchial atypia, a putatively premalignant condition. Sputum sampling is a simple, non-invasive method of assessing atypia. Smokers with at least a 15 pack-year history were screened for sputum atypia. One hundred and fifty subjects' were randomised to receive the synthetic retinoid etretinate 25 mg orally or identical placebo daily for 6 months. Compliance was measured by performing pill count...

  13. Dissemination of the published results of an important clinical trial: an analysis of the citing literature.

    OpenAIRE

    Dunn, D R

    1981-01-01

    The definitive clinical trial which demonstrated the beneficial effects of photocoagulation in treating diabetic retinopathy was reported in 1976 in the American Journal of Ophthalmology by the Diabetic Retinopathy Study (DRS) Research Group. Despite the importance of this report, eighteen months after it appeared in print the photocoagulation technique was still not widely known to a population of physicians whose practice included an appreciable number of diabetic patients. As part of a stu...

  14. Defining a COPD composite safety endpoint for demonstrating efficacy in clinical trials: results from the randomized, placebo-controlled UPLIFT® trial

    OpenAIRE

    Celli, Bartolomé R; Decramer, Marc; Liu, Dacheng; Metzdorf, Norbert; Asijee, Guus M; Tashkin, Donald P.

    2016-01-01

    Background Chronic obstructive pulmonary disease (COPD) clinical trials evaluating hard endpoints (mortality, hospitalized exacerbations) require a large number of subjects and prolonged observational periods. We hypothesized that a composite endpoint of respiratory outcomes (CERO) can help evaluate safety and benefit in COPD trials. Methods Retrospective analysis of 5992 patients enrolled in the 4-year UPLIFT® trial, a randomized trial of tiotropium versus placebo in patients with moderate-t...

  15. Alternative Calculations of Individual Patient Time in Therapeutic Range While Taking Warfarin: Results From the ROCKET AF Trial

    Science.gov (United States)

    Singer, Daniel E.; Hellkamp, Anne S.; Yuan, Zhong; Lokhnygina, Yuliya; Patel, Manesh R.; Piccini, Jonathan P.; Hankey, Graeme J.; Breithardt, Günter; Halperin, Jonathan L.; Becker, Richard C.; Hacke, Werner; Nessel, Christopher C.; Mahaffey, Kenneth W.; Fox, Keith A. A.; Califf, Robert M.

    2015-01-01

    Background In the ROCKET AF (Rivaroxaban–Once‐daily, oral, direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) trial, marked regional differences in control of warfarin anticoagulation, measured as the average individual patient time in the therapeutic range (iTTR) of the international normalized ratio (INR), were associated with longer inter‐INR test intervals. The standard Rosendaal approach can produce biased low estimates of TTR after an appropriate dose change if the follow‐up INR test interval is prolonged. We explored the effect of alternative calculations of TTR that more immediately account for dose changes on regional differences in mean iTTR in the ROCKET AF trial. Methods and Results We used an INR imputation method that accounts for dose change. We compared group mean iTTR values between our dose change–based method with the standard Rosendaal method and determined that the differences between approaches depended on the balance of dose changes that produced in‐range INRs (“corrections”) versus INRs that were out of range in the opposite direction (“overshoots”). In ROCKET AF, the overall mean iTTR of 55.2% (Rosendaal) increased up to 3.1% by using the dose change–based approach, depending on assumptions. However, large inter‐regional differences in anticoagulation control persisted. Conclusions TTR, the standard measure of control of warfarin anticoagulation, depends on imputing daily INR values for the vast majority of follow‐up days. Our TTR calculation method may better reflect the impact of warfarin dose changes than the Rosendaal approach. In the ROCKET AF trial, this dose change–based approach led to a modest increase in overall mean iTTR but did not materially affect the large inter‐regional differences previously reported. Clinical Trial Registration URL: ClinicalTrials.gov. Unique identifier: NCT00403767. PMID:25736441

  16. Botulinum toxin to improve results in cleft lip repair: a double-blinded, randomized, vehicle-controlled clinical trial.

    Directory of Open Access Journals (Sweden)

    Chun-Shin Chang

    Full Text Available BACKGROUND: Most patients with facial scarring would value even a slight improvement in scar quality. Botulinum toxin A is widely used to alleviate facial dynamic rhytides but is also believed to improve scar quality by reducing wound tension during healing. The main objective was to assess the effect of Botulinum toxin on scars resultant from standardized upper lip wounds. METHODS: In this double-blinded, randomized, vehicle-controlled, prospective clinical trial, 60 consecutive consenting adults undergoing cleft lip scar revision (CLSR surgery between July 2010 and March 2012 were randomized to receive botulinum toxin A (n = 30 or vehicle (normal saline; n = 30 injections into the subjacent orbicularis oris muscle immediately after wound closure. Scars were independently assessed at 6-months follow-up in blinded fashion using: Vancouver Scar Scale (VSS, Visual Analogue Scale (VAS and photographic plus ultrasound measurements of scar widths. RESULTS: 58 patients completed the trial. All scar assessment modalities revealed statistically significantly better scars in the experimental than the vehicle-control group. CONCLUSION: Quality of surgical upper lip scars, which are oriented perpendicular to the direction of pull of the underlying orbicularis oris muscle, is significantly improved by its temporary paralysis during wound healing. TRIAL REGISTRATION: ClinicalTrials.gov NCT01429402.

  17. Association of Symptomatic Benign Prostatic Hyperplasia and Prostate Cancer: Results from the Prostate Cancer Prevention Trial

    OpenAIRE

    Schenk, Jeannette M.; Kristal, Alan R.; Arnold, Kathryn B.; Tangen, Catherine M.; Neuhouser, Marian L; Lin, Daniel W; White, Emily; Thompson, Ian M

    2011-01-01

    This study examined the association between symptomatic benign prostatic hyperplasia (BPH) and prostate cancer risk in 5,068 placebo-arm participants enrolled in the Prostate Cancer Prevention Trial (1993–2003). These data include 1,225 men whose cancer was detected during the 7-year trial—556 detected for cause (following abnormal prostate-specific antigen or digital rectal examination) and 669 detected not for cause (without indication), as well as 3,843 men who had biopsy-proven absence of...

  18. Preliminary ten year results from a randomised single centre mass screening trial for abdominal aortic aneurysm

    DEFF Research Database (Denmark)

    Lindholt, Jes S.; Juul, Svend; Fasting, Helge;

    2006-01-01

    BACKGROUND: At present, several regions and countries are considering screening for abdominal aortic aneurysm (AAA). However, The Chichester Aneurysms Screening Trial has reported poor long term benefit of screening for AAA. We therefore supplement previously published data with a preliminary......,333 were invited to an abdominal ultrasound scan at their district hospital. Information on all deaths until 15.3.2005 was obtained from the Office of Civil Registration. Information on AAA related deaths was obtained from the national registry of Causes of Deaths from 1.4.1994 to 31...

  19. Choice of study endpoint significantly impacts the results of breast cancer trials evaluating chemotherapy-induced nausea and vomiting.

    Science.gov (United States)

    Ng, Terry; Mazzarello, Sasha; Wang, Zhou; Hutton, Brian; Dranitsaris, George; Vandermeer, Lisa; Smith, Stephanie; Clemons, Mark

    2016-01-01

    Multiple endpoints can be used to evaluate chemotherapy-induced nausea and vomiting (CINV). These endpoints reflect the various combinations of vomiting, nausea and rescue antiemetic use in the acute (0-24 h), delayed (>24-120 h) and overall (0-120 h) periods after chemotherapy. As the choice of outcome measure could potentially change the interpretation of clinical trial results, we evaluated CINV rates using different endpoints on a single dataset from a prospective cohort. Data from 177 breast cancer patients receiving anthracycline and cyclophosphamide-based chemotherapy was used to calculate CINV control rates using the 15 most commonly reported CINV endpoints. As nausea remains such a significant symptom, we explored the frequency at which pharmaceutical and non-pharmaceutical company-funded studies included measures of nausea in their primary study endpoint. CINV control rates ranged from 12.5 %, 95 % (CI 7.6-17.4 %) for total control (no vomiting, no nausea and no rescue medication) in the overall period to 77.4 %, 95 % (CI 71.2-83.6 %) for no vomiting in the overall period. Similar differences were found in the acute and delayed periods. Non-pharmaceutical company-funded trials were more likely to include a measure of nausea in the primary study outcome (9/18, 50 %) than pharmaceutical-funded trials (1/12, 8.3 %). The choice of trial endpoint has an important impact on reported CINV control rates and could significantly impact on interpretation of the results. Primary endpoints of studies, including those mandated by regulatory bodies, should account for nausea to reflect patient experience. Reporting of endpoints should be more comprehensive to allow for cross-trial comparisons.

  20. Assessment of the consistency and robustness of results from a multicenter trial of remission maintenance therapy for acute myeloid leukemia

    Directory of Open Access Journals (Sweden)

    Brune Mats L

    2011-03-01

    Full Text Available Abstract Background Data from a randomized multinational phase 3 trial of 320 adults with acute myeloid leukemia (AML demonstrated that maintenance therapy with 3-week cycles of histamine dihydrochloride plus low-dose interleukin-2 (HDC/IL-2 for up to 18 months significantly improved leukemia-free survival (LFS but lacked power to detect an overall survival (OS difference. Purpose To assess the consistency of treatment benefit across patient subsets and the robustness of data with respect to trial centers and endpoints. Methods Forest plots were constructed with hazard ratios (HRs of HDC/IL-2 treatment effects versus no treatment (control for prospectively defined patient subsets. Inconsistency coefficients (I2 and interaction tests (X2 were used to detect any differences in benefit among subsets. Robustness of results to the elimination of individual study centers was performed using "leave-one-center-out" analyses. Associations between treatment effects on the endpoints were evaluated using weighted linear regression between HRs for LFS and OS estimated within countries. Results The benefit of HDC/IL-2 over controls was statistically consistent across all subsets defined by baseline prognostic variables. I2 and P-values of X2 ranged from 0.00 to 0.51 and 0.14 to 0.91, respectively. Treatment effects were statistically significant in 14 of 28 subsets analyzed. The "leave-one-center-out" analysis confirmed that no single center dominated (P-values ranged from 0.004 to 0.020 [mean 0.009]. The HRs representing the HDC/IL-2 effects on LFS and OS were strongly correlated at the country level (R2 = 0.84. Limitations Small sample sizes in some of the subsets analyzed. Conclusions These analyses confirm the consistency and robustness of the HDC/IL-2 effect as compared with no treatment. LFS may be an acceptable surrogate for OS in future AML trials. Analyses of consistency and robustness may aid interpretation of data from multicenter trials

  1. The International Remote Monitoring Project -- First results of the Argentina nuclear power station field trial

    Energy Technology Data Exchange (ETDEWEB)

    Bonino, A.; Pizarro, L.; Perez, A. [Ente Nacional Regulador Nuclear, Buenos Aires (Argentina); Schoeneman, J.L.; Dupree, S.A.; Martinez, R.L. [Sandia National Labs., Albuquerque, NM (United States); Maxey, C. [Oak Ridge National Lab., TN (United States)

    1995-12-31

    As part of the International Remote Monitoring Project field trials, during the month of March, 1995 a Remote Monitoring System (RMS) was installed at the Embalse Nuclear Power Station in Embalse, Argentina. This system monitors the status of four typical Candu spent fuel dry storage silos. The monitoring equipment for each silo consists of analog temperature and gamma radiation sensors and digital motion and electronic fiber-optic seals connected to a wireless Authenticate Item Monitoring System (AIMS). All sensor data are authenticated and transmitted via RF link to Receiver Processor Units (RPU) coupled to Remote Monitoring System equipment located in a nearby IAEA/ENREN inspector office. One of these RPUs is connected to Remote Monitoring equipment capable of information transmission (via commercial telephone links) to Data Review Stations (DRS) at ENREN laboratories in Buenos Aires, Argentina, and at Sandia National Laboratories, Albuquerque, New Mexico. The other RPU is used for on-site data storage and analysis. It is anticipated that this information will soon be transmitted to a DRS at the ABACC facility in Rio de Janeiro, Brazil. During these trials site data will be collected and analyzed periodically from Buenos Aires, Albuquerque, and Rio de Janeiro. Installation detail and data analysis will be presented in this paper.

  2. Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres

    Directory of Open Access Journals (Sweden)

    Doran Peter

    2010-07-01

    Full Text Available Abstract Background The use of Clinical Data Management Systems (CDMS has become essential in clinical trials to handle the increasing amount of data that must be collected and analyzed. With a CDMS trial data are captured at investigator sites with "electronic Case Report Forms". Although more and more of these electronic data management systems are used in academic research centres an overview of CDMS products and of available data management and quality management resources for academic clinical trials in Europe is missing. Methods The ECRIN (European Clinical Research Infrastructure Network data management working group conducted a two-part standardized survey on data management, software tools, and quality management for clinical trials. The questionnaires were answered by nearly 80 centres/units (with an overall response rate of 47% and 43% from 12 European countries and EORTC. Results Our survey shows that about 90% of centres have a CDMS in routine use. Of these CDMS nearly 50% are commercial systems; Open Source solutions don't play a major role. In general, solutions used for clinical data management are very heterogeneous: 20 different commercial CDMS products (7 Open Source solutions in addition to 17/18 proprietary systems are in use. The most widely employed CDMS products are MACRO™ and Capture System™, followed by solutions that are used in at least 3 centres: eResearch Network™, CleanWeb™, GCP Base™ and SAS™. Although quality management systems for data management are in place in most centres/units, there exist some deficits in the area of system validation. Conclusions Because the considerable heterogeneity of data management software solutions may be a hindrance to cooperation based on trial data exchange, standards like CDISC (Clinical Data Interchange Standard Consortium should be implemented more widely. In a heterogeneous environment the use of data standards can simplify data exchange, increase the quality of

  3. Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: Results of a survey

    Directory of Open Access Journals (Sweden)

    Vale Claire L

    2012-01-01

    Full Text Available Abstract Background We aimed to establish levels of consumer involvement in randomised controlled trials (RCTs, meta-analyses and other studies carried out by the UK Medical Research Council (MRC Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV. Methods Staff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009 were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research. Results Between October 2009 and April 2010, 138 completed questionnaires (86% were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31% had some consumer involvement, most commonly as members of trial management groups (TMG [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers. Conclusions Whilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development

  4. Largemouth bass (Micropterus salmoides Lacépède: results of farming trials

    Directory of Open Access Journals (Sweden)

    R. Vicenzi

    2010-01-01

    Full Text Available In the last years in the United States, the demand of largemouth bass (Micropterus salmoides larger than the size usually produced for sport fishing purposes has increased. The growth phase is carried on in ponds, after having evaluated different strains (Williamson and Carmichael, 1990 using feeds for salmonids (Tidwell et al., 1996 supplemented with amino acids (Coyle et al., 2000. Also in Italy, the market currently requires largemouth bass of 300-500 g. This situation has induced one farmer to cooperate with our research centre and carried out trials to verify the possibility of rearing this fish, from the fingerling stage up to the size suitable for food, using the same farming techniques as those currently being applied in the United States (Davis and Lock, 1997.

  5. Treating fibromyalgia with mindfulness-based stress reduction: results from a 3-armed randomized controlled trial.

    Science.gov (United States)

    Schmidt, Stefan; Grossman, Paul; Schwarzer, Barbara; Jena, Susanne; Naumann, Johannes; Walach, Harald

    2011-02-01

    Mindfulness-based stress reduction (MBSR) is a structured 8-week group program teaching mindfulness meditation and mindful yoga exercises. MBSR aims to help participants develop nonjudgmental awareness of moment-to-moment experience. Fibromyalgia is a clinical syndrome with chronic pain, fatigue, and insomnia as major symptoms. Efficacy of MBSR for enhanced well-being of fibromyalgia patients was investigated in a 3-armed trial, which was a follow-up to an earlier quasi-randomized investigation. A total of 177 female patients were randomized to one of the following: (1) MBSR, (2) an active control procedure controlling for nonspecific effects of MBSR, or (3) a wait list. The major outcome was health-related quality of life (HRQoL) 2 months post-treatment. Secondary outcomes were disorder-specific quality of life, depression, pain, anxiety, somatic complaints, and a proposed index of mindfulness. Of the patients, 82% completed the study. There were no significant differences between groups on primary outcome, but patients overall improved in HRQoL at short-term follow-up (P=0.004). Post hoc analyses showed that only MBSR manifested a significant pre-to-post-intervention improvement in HRQoL (P=0.02). Furthermore, multivariate analysis of secondary measures indicated modest benefits for MBSR patients. MBSR yielded significant pre-to-post-intervention improvements in 6 of 8 secondary outcome variables, the active control in 3, and the wait list in 2. In conclusion, primary outcome analyses did not support the efficacy of MBSR in fibromyalgia, although patients in the MBSR arm appeared to benefit most. Effect sizes were small compared to the earlier, quasi-randomized investigation. Several methodological aspects are discussed, e.g., patient burden, treatment preference and motivation, that may provide explanations for differences. In a 3-armed randomized controlled trial in female patients suffering from fibromyalgia, patients benefited modestly from a mindfulness

  6. Radiotherapy for calcaneodynia. Results of a single center prospective randomized dose optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Jeremias, C.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Dept. of Radiation Oncology

    2013-04-15

    The aim of this work was to compare the efficacy of two different dose fractionation schedules for radiotherapy of patients with calcaneodynia. Between February 2006 and April 2010, 457 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy using the orthovoltage technique. One radiotherapy series consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, immediately after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 87 % directly after and 88 % 6 weeks after radiotherapy. The mean VAS values before, immediately after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 65.5 {+-} 22.1 and 64.0 {+-} 20.5 (p = 0.188), 34.8 {+-} 24.7 and 39.0 {+-} 26.3 (p = 0.122), and 25.1 {+-} 26.8 and 28.9 {+-} 26.8 (p = 0.156), respectively. The mean CPS before, immediately after, and 6 weeks after treatment was 10.1 {+-} 2.7 and 10.0 {+-} 3.0 (p = 0.783), 5.6 {+-} 3.7 and 6.0 {+-} 3.9 (p = 0.336), 4.0 {+-} 4.1 and 4.3 {+-} 3.6 (p = 0.257), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.216) and delayed response (p = 0.080) were found. Radiotherapy is an effective treatment option for the management of calcaneodynia. For radiation protection reasons, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  7. Long-term results of Troidl's technique of endoscopic pneumatic dilatation for achalasia of the esophagus. A prospective clinical trial.

    Science.gov (United States)

    Eypasch, E; Troidl, H; Sommer, H; Vestweber, K H

    1987-01-01

    In a prospective clinical trial, 26 consecutive patients underwent endoscopic pneumatic dilatation over a 10-year period. Dilatation was achieved by means of a balloon attached to a normal gastrointestinal fiberscope. With the endoscope in an inverse position, the device was placed in the cardia and the dilatation process was monitored macroscopically. Before dilatation, patients suffered from dysphagia (92%), reduced speed of swallowing (100%), symptom aggravation under stress (73%), weight loss (50%), aspiration, pain, regurgitation, and vomiting. After dilatation and long-term follow-up (mean of 5 years), symptoms could be markedly reduced, especially the speed of eating and symptom aggravation under stress. Excellent and good results (Visick scale) were achieved in 76%. Fair results were achieved in 20%. To date, perforation and other complications have not occurred. Mortality was zero. Our series was an uncontrolled trial, so the results are hardly comparable to other studies. Furthermore, the small number of patients in our study represents a weak point with regard to complications. We conclude that the main advantages of the procedure are its simplicity and practicability. The simple procedure may be the method of choice in elderly patients. Of course, no final decision can be made until a well-designed controlled trial has been carried out.

  8. To whom do the results of the multicenter, randomized, controlled INSECT trial (ISRCTN 24023541 apply? - assessment of external validity

    Directory of Open Access Journals (Sweden)

    Fischer Lars

    2012-02-01

    Full Text Available Abstract A response to Seiler et al: Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicenter randomized trial (INSECT: ISRCTN24023541. Ann Surg 2009, 249(4:576-582. Background Existing evidence suggests that the transfer of results of randomized controlled trials into clinical practice may be limited. Potential reasons can be attributed to aspects of external validity. The aim of this study is to investigate issues related to the external validity of the INSECT trial. Methods All participating surgical departments were categorized and the clinical and baseline characteristics of randomized patients were evaluated. In addition, demographic and clinical data of all screened and randomized patients at the Departments of Surgery in Heidelberg and Erlangen were analyzed. Results Twenty-five centers enrolled a total of 625 patients. These centers included eight primary, 11 secondary, and six tertiary care centers. The tertiary care centers enrolled the most patients (n = 237, 38% followed by the primary care centers (n = 199, 32% and the secondary care centers (n = 189 patients; 30%. The mean number and baseline data of randomized patients did not differ between the three types of care centers (p = 0.09. Overall, the treatment according to protocol was at least 92%. At the Department of Surgery, University of Heidelberg, 307 patients were screened and 60 out of 130 eligible patients were randomized. There were no differences in demographic and clinical baseline data between included and non-included patients. In Erlangen, 351 patients were screened and 57 out of 106 eligible patients randomized. Conclusions Results of the INSECT trial are applicable to a broad spectrum of patients treated at different hospital levels.

  9. Novel nonpharmacologic approaches for stroke prevention in atrial fibrillation: results from clinical trials

    Directory of Open Access Journals (Sweden)

    Proietti R

    2015-01-01

    Full Text Available Riccardo Proietti,1,2 Jacqueline Joza,1 Andrea Arensi,2 Michael Levi,1 Vincenzo Russo,3 Apostolos Tzikas,4 Paolo Danna,2 Antonio Sagone,2 Maurizio Viecca,2 Vidal Essebag1,5 1McGill University Health Center, Montreal, QC, Canada; 2Cardiology Department, Luigi Sacco Hospital, Milano, Italy; 3Cardiology Department, Second University of Naples, Monaldi Hospital, Naples, Italy; 4Interbalkan European Medical Centre, Thessaloniki, Greece; 5Hôpital Sacré-Coeur de Montréal, Montreal, QC, Canada Abstract: Atrial fibrillation (AF, the most common cardiac arrhythmia, confers a 5-fold risk of stroke that increases to 17-fold when associated with mitral stenosis. At this time, the most effective long-term solution to protect patients from stroke and thromboembolism is oral anticoagulation, either with vitamin K antagonists (VKAs or a novel oral anticoagulant (NOAC. Despite the significant benefits they confer, both VKAs and NOACs are underused because of their increased potential for bleeding, and VKAs are underused because of their narrow therapeutic range, need for regular international normalized ratio checks, and interactions with food or medications. In patients with nonvalvular AF, approximately 90% of strokes originate from the left atrial appendage (LAA; in patients with rheumatic mitral valve disease, many patients (60% have strokes that originate from the left atrium itself. Surgical LAA amputation or closure, although widely used to reduce stroke risk in association with cardiac surgery, is not currently performed as a stand-alone operation for stroke risk reduction because of its invasiveness. Percutaneous LAA closure, as an alternative to anticoagulation, has been increasingly used during the last decade in an effort to reduce stroke risk in nonvalvular AF. Several devices have been introduced during this time, of which one has demonstrated noninferiority compared with warfarin in a randomized controlled trial. This review describes the

  10. Do Instructional Videos on Sputum Submission Result in Increased Tuberculosis Case Detection? A Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Grace Mhalu

    Full Text Available We examined the effect of an instructional video about the production of diagnostic sputum on case detection of tuberculosis (TB, and evaluated the acceptance of the video.Randomized controlled trial.We prepared a culturally adapted instructional video for sputum submission. We analyzed 200 presumptive TB cases coughing for more than two weeks who attended the outpatient department of the governmental Municipal Hospital in Mwananyamala (Dar es Salaam, Tanzania. They were randomly assigned to either receive instructions on sputum submission using the video before submission (intervention group, n = 100 or standard of care (control group, n = 100. Sputum samples were examined for volume, quality and presence of acid-fast bacilli by experienced laboratory technicians blinded to study groups.Median age was 39.1 years (interquartile range 37.0-50.0; 94 (47% were females, 106 (53% were males, and 49 (24.5% were HIV-infected. We found that the instructional video intervention was associated with detection of a higher proportion of microscopically confirmed cases (56%, 95% confidence interval [95% CI] 45.7-65.9%, sputum smear positive patients in the intervention group versus 23%, 95% CI 15.2-32.5%, in the control group, p <0.0001, an increase in volume of specimen defined as a volume ≥3ml (78%, 95% CI 68.6-85.7%, versus 45%, 95% CI 35.0-55.3%, p <0.0001, and specimens less likely to be salivary (14%, 95% CI 7.9-22.4%, versus 39%, 95% CI 29.4-49.3%, p = 0.0001. Older age, but not the HIV status or sex, modified the effectiveness of the intervention by improving it positively. When asked how well the video instructions were understood, the majority of patients in the intervention group reported to have understood the video instructions well (97%. Most of the patients thought the video would be useful in the cultural setting of Tanzania (92%.Sputum submission instructional videos increased the yield of tuberculosis cases through better quality of sputum

  11. Adolescents' impressions of antismoking media literacy education: qualitative results from a randomized controlled trial.

    Science.gov (United States)

    Primack, Brian A; Fine, Danielle; Yang, Christopher K; Wickett, Dustin; Zickmund, Susan

    2009-08-01

    Although media literacy represents an innovative venue for school-based antismoking programming, studies have not systematically compared student impressions of these and traditional programs. This study utilized data from a randomized trial comparing these two types of programs. After each program, students responded to three open-ended questions related to their assigned curriculum. Two coders, blinded to student assignments, independently coded these data. Coders had strong inter-rater agreement (kappa = 0.77). Our primary measures were spontaneously noted overall assessment, enjoyment/interest and the likelihood of changing smoking behavior. Of the 531 participants, 255 (48.0%) were randomized to the intervention (media literacy) group. Intervention participants had more net positive responses [rate ratio (RR) = 1.27, 95% confidence interval (CI) = 1.05, 1.54], more responses rating the program as compelling (RR = 1.63, 95% CI = 1.16, 2.29) and fewer responses rating the program as non-compelling (RR = 0.62, 95% CI = 0.39, 0.97). However, the intervention group was not more likely to suggest that the curriculum was likely to change behavior positively (RR = 0.57, 95% CI = 0.30, 1.06). Findings suggest that although media literacy provides a compelling format for the delivery of anti-tobacco programming, integration of components of traditional programming may help media literacy programs achieve maximal efficacy.

  12. Changes in symptoms of depression with weight loss: results of a randomized trial.

    Science.gov (United States)

    Faulconbridge, Lucy F; Wadden, Thomas A; Berkowitz, Robert I; Sarwer, David B; Womble, Leslie G; Hesson, Louise A; Stunkard, Albert J; Fabricatore, Anthony N

    2009-05-01

    Recent studies of rimonabant have re-awakened interest in the possible adverse psychiatric effects of weight loss, as well as of weight loss medications. This study examined changes in symptoms of depression in 194 obese participants (age = 43.7 +/- 10.2 years; BMI = 37.6 +/- 4.1 kg/m(2)) in a 1-year randomized trial of lifestyle modification and medication. Participants were assigned to (i) sibutramine alone; (ii) lifestyle modification alone; (iii) sibutramine plus lifestyle modification (i.e., combined therapy); or (iv) sibutramine plus brief therapy. Participants completed the Beck Depression Inventory-II (BDI-II) at baseline and weeks 6, 10, 18, 26, 40, and 52. At 1 year, participants in combined therapy lost the most weight and those in sibutramine alone the least (12.1 +/- 8.8% vs. 5.5 +/- 6.5%; P or= 5 points on the BDI-II) in symptoms of depression at week 52. They lost significantly less weight than participants in the rest of the sample (5.4 +/- 7.8% vs. 9.0 +/- 7.8%, respectively; P < 0.03). The baseline prevalence of suicidal ideation was 3.6%. Seven new cases of suicidal ideation were observed during the year, with three in lifestyle modification alone. Further research is needed to identify characteristics of obese patients at risk of negative mood changes (and suicidal ideation) in response to behavioral and pharmacologic therapies. PMID:19197266

  13. Combination treatment in Alzheimer's disease: results of a randomized, controlled trial with cerebrolysin and donepezil.

    Science.gov (United States)

    Alvarez, X Antón; Cacabelos, R; Sampedro, C; Couceiro, V; Aleixandre, M; Vargas, M; Linares, C; Granizo, E; García-Fantini, M; Baurecht, W; Doppler, E; Moessler, H

    2011-08-01

    Treatment with neurotrophic agents might enhance and/or prolong the effects of cholinesterase inhibitors (ChEIs) in Alzheimer's disease (AD). We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial. Primary endpoints were global outcome (Clinician's Interview-Based Impression of Change plus caregiver input; CIBIC+) and cognition (change from baseline in AD Assessment Scale-cognitive subscale+; ADAS-cog+) at week 28. Changes in functioning (AD Cooperative Study-Activities of Daily Living scale, ADCS-ADL) and behaviour (Neuropsychiatric Inventory, NPI) were secondary endpoints. Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy. Cognitive performance improved in all treatment groups (mean±SD for Cerebrolysin: -1.7±7.5; donepezil: -1.2±6.1; combination: -2.3±6.0) with best scores in the combined therapy group at all study visits. Cerebrolysin was as effective as donepezil, and the combination of neurotrophic (Cerebrolysin) and cholinergic (donepezil) treatment was safe in mild-to-moderate AD. The convenience of exploring long-term synergistic effects of this combined therapy is suggested.

  14. Gender Differences in Borderline Personality Disorder: Results From a Multinational, Clinical Trial Sample.

    Science.gov (United States)

    Silberschmidt, Amy; Lee, Susanne; Zanarini, Mary; Schulz, S Charles

    2015-12-01

    This study aims to extend previous research by considering gender differences in borderline personality (BPD) using both dimensional self-reported and clinical measures of symptomatology. Drawing from a cross-cultural, clinical trial sample, the authors compared female and male BPD subjects (N = 770; 211 male) between the ages of 18 and 65 using diagnostic and self-report data. The authors found that women with BPD have greater hostility and relationship disruption than men. Gender differences in eating disorders, particularly bulimia, are more divergent than in the general population. Generally, gender differences in BPD in this sample are consistent with known general population differences. Women show greater overall symptomatology, including depressive, anxious, and somatic symptoms. Men have higher rates of antisocial personality disorder and a trend toward higher rates of narcissistic personality disorder. However, several gender differences consistently found in the general population are not present in this BPD sample. There are no differences in aggression, suicidality, substance abuse, panic disorder, or obsessive-compulsive disorder. Gender differences in major depression and posttraumatic stress disorder are attenuated. These findings support the conclusion that BPD may diminish normal gender differences. PMID:25562535

  15. Irrefutable evidence for the use of docetaxel in newly diagnosed metastatic prostate cancer: results from the STAMPEDE and CHAARTED trials.

    Science.gov (United States)

    van Soest, Robert J; de Wit, Ronald

    2015-01-01

    Androgen deprivation therapy (ADT) has been used in the treatment of metastatic prostate cancer since the first description of its hormonal dependence in 1941. In 2004, docetaxel chemotherapy became the mainstay of treatment in metastatic castration-resistant prostate cancer (mCRPC), following robust, albeit modest, survival benefit in two randomized phase 3 trials. The recently published CHAARTED trial was the first to show that combining ADT with docetaxel in men with hormone-naïve (hormone-sensitive) metastatic prostate cancer (mHSPC) yielded a remarkable overall survival benefit of 13.6 months as compared with ADT alone. In the current issue of The Lancet, James et al. report results of the STAMPEDE trial in men with high-risk locally advanced or metastatic prostate cancer initiating long-term hormone therapy. The combination of six cycles of docetaxel with ADT in men commencing long-term ADT demonstrated a similar OS benefit compared with standard of care (SOC) by a median of 10 months. Based on the consistency of the data and the firmness of the benefit provided, docetaxel in addition to ADT should be considered SOC for men with newly diagnosed mHSPC. PMID:26695172

  16. [Results of Russian multicenter trial of immunogenicity, reactogenicity and safety of new combination vaccine against hepatitis A and B (Twinrix)].

    Science.gov (United States)

    Tatochenko, V K; Il'ina, N I; Romanenko, V V; Alikova, O A; Fassakhov, R S; Miasnikova, T N; Patlusova, V V; Zima, Iu Iu; Reshetnikova, I D; Frolova, G S; Smolenov, I V

    2006-01-01

    Results of registration trial of combination vaccine for prevention of hepatitis A and B are presented. The trial was conducted in 5 centers of Russia in 2004-2005 with full accordance to good clinical practice requirements and standards for multicenter open randomized trials. Immunogenicity of studied combination vaccine Twinrix was evaluated in comparison with two simultaneously administered monovalent vaccines against hepatitis A and B (Havrix and Engerix-B) in 200 healthy subjects aged 18-40, which were seronegative to hepatitis A and B. Reactogenicity based on interviewed and non-interviewed symptoms ranged on intensity was assessed also. 1 month after completion of primary vaccination all subjects in both groups were seropositive to hepatitis A. Sero-protection level of antibodies to hepatitis B virus was detected in 98.9% of participants vaccinated with Twinrix and in 95.6% of participants vaccinated with Engerix-B and Havrix. Overall, reactogenicity of vaccines was minor, marked adverse events caused by vaccination were rare (approximately 1%). Study shows that combination vaccine against hepatitis A and B (Twinrix) at least non inferior in terms of immunogenicity, safety and tolerability to monovalent vaccines (Havrix and Engerix-B), were registered in Russia.

  17. Helicobacter pylori, cyclooxygenase-2 and evolution of gastric lesions: results from an intervention trial in China.

    Science.gov (United States)

    Zhang, Yang; Pan, Kai-Feng; Zhang, Lian; Ma, Jun-Ling; Zhou, Tong; Li, Ji-You; Shen, Lin; You, Wei-Cheng

    2015-12-01

    To investigate the role of cyclooxygenase (COX)-2/prostaglandin E2 (PGE2) in the process of Helicobacter pylori-induced gastric carcinogenesis, a prospective study based on an intervention trial was conducted in Linqu County, China. A total of 1401 subjects with histopathologic diagnosis were investigated at baseline, among those, 919 completed subsequent interventions (anti-H.pylori and/or celecoxib treatment). Expressions of COX-2 and Ki-67 were assessed by immunohistochemistry, and PGE2 levels were measured by enzyme immunoassay before and after interventions, respectively. We found a grade-response relationship between COX-2 expression level and risk of advanced gastric lesions at baseline. Stratified analysis indicated an additive interaction between COX-2 expression and H.pylori infection on the elevated risk of advanced gastric lesions. The odds ratios (ORs) for both factors combined were 9.31 [95% confidence interval (CI): 4.13-20.95] for chronic atrophic gastritis, 16.26 (95% CI: 7.29-36.24) for intestinal metaplasia and 21.13 (95% CI: 7.87-56.75) for dysplasia, respectively. After interventions, COX-2 expression and Ki-67 labeling index (LI) were decreased in anti-H.pylori group (OR: 1.65, 95% CI: 1.36-1.99 for COX-2; OR: 1.78, 95% CI: 1.49-2.12 for Ki-67) or anti-H.pylori followed by celecoxib group (OR: 1.41, 95% CI: 1.17-1.70 for COX-2; OR: 1.63, 95% CI: 1.37-1.94 for Ki-67). PGE2 levels were decreased in all treatment groups. Furthermore, the regression of gastric lesions was associated with the decrease of COX-2 expression or Ki-67 LI after interventions. Our findings indicate that H.pylori-induced COX-2/PGE2 pathways play an important role on the progression of precancerous gastric lesions in a Chinese population. PMID:26449252

  18. Tumor induction following intraoperative radiotherapy: Late results of the National Cancer Institute canine trials

    Energy Technology Data Exchange (ETDEWEB)

    Barnes, M.; Duray, P.; DeLuca, A.; Anderson, W.; Sindelar, W.; Kinsella, T. (Fox Chase Cancer Center, Philadelphia, PA (USA))

    1990-09-01

    Intraoperative radiotherapy has been employed in human cancer research for over a decade. Since 1979, trials to assess the acute and late toxicity of IORT have been carried out at the National Cancer Institute in an adult dog model in an attempt to establish dose tolerance guidelines for a variety of organs. Of the 170 animals entered on 12 studies with a minimum follow-up of 2 years, 148 dogs received IORT; 22 control animals received only surgery. Animals were sacrificed at designated intervals following IORT, usually at 1, 6, 12, 24, and 60 month intervals. 102 of 148 irradiated dogs were sacrificed less than 24 months; 46 dogs were followed greater than or equal to 24 months after IORT. To date, 34 of the 46 animals have been sacrificed; the 12 remaining animals are to be followed to 5 years. These 12 animals have minimum follow-up of 30 months. In the irradiated group followed for greater than or equal to 24 months, 10 tumors have arisen in 9 animals. One animal developed an incidental spontaneous breast carcinoma outside the IORT port, discovered only at scheduled post-mortem exam. The remaining nine tumors arose within IORT ports. Two tumors were benign neural tumors--a neuroma and a neurofibroma. One animal had a collision tumor comprised of grade I chondrosarcoma adjacent to grade III osteosarcoma arising in lumbar vertebrae. Two other grade III osteosarcomas, one grade III fibrosarcoma, and one grade III malignant fibrous histiocytoma arose in retroperitoneal/paravertebral sites. An embryonal rhabdomyosarcoma (sarcoma botryoides) arose within the irradiated urinary bladder of one animal. No sham irradiated controls nor IORT animals sacrificed less than 24 months have developed any spontaneous or radiation-induced tumors. The time range of diagnoses of tumors was 24-58 months. The IORT dose range associated with tumor development was 20-35 Gy.

  19. Analyses of Results From Cardiovascular Safety Trials With DPP-4 Inhibitors: Cardiovascular Outcomes, Predefined Safety Outcomes, and Pooled Analysis and Meta-analysis.

    Science.gov (United States)

    Mannucci, Edoardo; Mosenzon, Ofri; Avogaro, Angelo

    2016-08-01

    The U.S. Food and Drug Administration requires that the cardiovascular (CV) safety of all new drugs for diabetes be demonstrated through pooled analyses of phase III studies or specifically designed trials. This requirement prompted several placebo-controlled, noninferiority CV safety trials in high-risk patients; to date, all completed trials showed that dipeptidyl peptidase (DPP)-4 inhibitors do not increase or reduce the risk of major CV events. These results apparently contrast with those of pooled analyses and meta-analyses of previous, smaller trials with metabolic end points, which had suggested a reduction of risk. However, the design of CV trials, which were required to demonstrate safety, is not adequate (for duration, management of concurrent therapies, etc.) for the assessment of potential therapeutic benefits. In addition, CV safety trials enroll patients at high risk of CV events, who are different from those included in earlier trials with metabolic end points. Differences in characteristics of patients enrolled probably account for most of the discrepancy in CV outcomes between CV safety studies and earlier trials. The availability of several large-scale trials with longer duration provides the unique opportunity for assessment of the safety of DPP-4 inhibitors not only with respect to major CV events but also with reference to other safety issues. For example, CV safety trials can be a source of information for pancreatitis, cancer, or hypoglycemia. PMID:27440833

  20. Long term effectiveness on prescribing of two multifaceted educational interventions: results of two large scale randomized cluster trials.

    Directory of Open Access Journals (Sweden)

    Nicola Magrini

    Full Text Available INTRODUCTION: Information on benefits and risks of drugs is a key element affecting doctors' prescribing decisions. Outreach visits promoting independent information have proved moderately effective in changing prescribing behaviours. OBJECTIVES: Testing the short and long-term effectiveness on general practitioners' prescribing of small groups meetings led by pharmacists. METHODS: Two cluster open randomised controlled trials (RCTs were carried out in a large scale NHS setting. Ad hoc prepared evidence based material were used considering a therapeutic area approach--TEA, with information materials on osteoporosis or prostatic hyperplasia--and a single drug oriented approach--SIDRO, with information materials on me-too drugs of 2 different classes: barnidipine or prulifloxacin. In each study, all 115 Primary Care Groups in a Northern Italy area (2.2 million inhabitants, 1737 general practitioners were randomised to educational small groups meetings, in which available evidence was provided together with drug utilization data and clinical scenarios. Main outcomes were changes in the six-months prescription of targeted drugs. Longer term results (24 and 48 months were also evaluated. RESULTS: In the TEA trial, one of the four primary outcomes showed a reduction (prescription of alfuzosin compared to tamsulosin and terazosin in benign prostatic hyperplasia: prescribing ratio -8.5%, p = 0.03. Another primary outcome (prescription of risedronate showed a reduction at 24 and 48 months (-7.6%, p = 0.02; and -9,8%, p = 0.03, but not at six months (-5.1%, p = 0.36. In the SIDRO trial both primary outcomes showed a statistically significant reduction (prescription of barnidipine -9.8%, p = 0.02; prescription of prulifloxacin -11.1%, p = 0.04, which persisted or increased over time. INTERPRETATION: These two cluster RCTs showed the large scale feasibility of a complex educational program in a NHS setting, and its potentially

  1. The Erlangen Dose Optimization Trial for radiotherapy of benign painful shoulder syndrome. Long-term results

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany)

    2014-04-15

    To evaluate the long-term efficacy of pain reduction by two dose-fractionation schedules for radiotherapy of painful shoulder syndrome. Between February 2006 and February 2010, 312 evaluable patients were recruited for this prospective trial. All patients received low-dose orthovoltage radiotherapy. One course consisted of 6 fractions in 3 weeks. In the case of insufficient pain remission after 6 weeks, a second course was administered. Patients were randomly assigned to one of two groups to receive single doses of either 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before radiotherapy, as well as immediately after (early response), 6 weeks after (delayed response) and approximately 3 years after (long-term response) completion of radiotherapy using a questionnaire-based visual analogue scale (VAS) and a comprehensive pain score (CPS). Median follow-up was 35 months (range 11-57). The overall early, delayed and long-term response rates for all patients were 83, 85 and 82%, respectively. The mean VAS scores before treatment and those for early, delayed and long-term response in the 0.5- and 1.0-Gy groups were 56.8±23.7 and 53.2±21.8 (p=0.16); 38.2±36.1 and 34.0±24.5 (p=0.19); 33.0±27.2 and 23.7±22.7 (p=0.04) and 27.9±25.8 and 32.1±26.9 (p=0.25), respectively. The mean CPS values before treatment and those for early, delayed and long-term response were 9.7±3.0 and 9.5±2.7 (p=0.31); 6.1±3.6 and 5.4±3.6 (p=0.10); 5.3±3.7 and 4.1±3.7 (p=0.05) and 4.0±3.9 and 5.3±4.4 (p=0.05), respectively. No significant differences in the quality of the long-term response were found between the 0.5- and 1.0-Gy arms (p=0.28). Radiotherapy is an effective treatment for the management of benign painful shoulder syndrome. For radiation protection reasons, the dose for a radiotherapy series should not exceed 3.0 Gy. (orig.)

  2. The Erlangen Dose Optimization Trial for radiotherapy of benign painful shoulder syndrome. Long-term results

    International Nuclear Information System (INIS)

    To evaluate the long-term efficacy of pain reduction by two dose-fractionation schedules for radiotherapy of painful shoulder syndrome. Between February 2006 and February 2010, 312 evaluable patients were recruited for this prospective trial. All patients received low-dose orthovoltage radiotherapy. One course consisted of 6 fractions in 3 weeks. In the case of insufficient pain remission after 6 weeks, a second course was administered. Patients were randomly assigned to one of two groups to receive single doses of either 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before radiotherapy, as well as immediately after (early response), 6 weeks after (delayed response) and approximately 3 years after (long-term response) completion of radiotherapy using a questionnaire-based visual analogue scale (VAS) and a comprehensive pain score (CPS). Median follow-up was 35 months (range 11-57). The overall early, delayed and long-term response rates for all patients were 83, 85 and 82%, respectively. The mean VAS scores before treatment and those for early, delayed and long-term response in the 0.5- and 1.0-Gy groups were 56.8±23.7 and 53.2±21.8 (p=0.16); 38.2±36.1 and 34.0±24.5 (p=0.19); 33.0±27.2 and 23.7±22.7 (p=0.04) and 27.9±25.8 and 32.1±26.9 (p=0.25), respectively. The mean CPS values before treatment and those for early, delayed and long-term response were 9.7±3.0 and 9.5±2.7 (p=0.31); 6.1±3.6 and 5.4±3.6 (p=0.10); 5.3±3.7 and 4.1±3.7 (p=0.05) and 4.0±3.9 and 5.3±4.4 (p=0.05), respectively. No significant differences in the quality of the long-term response were found between the 0.5- and 1.0-Gy arms (p=0.28). Radiotherapy is an effective treatment for the management of benign painful shoulder syndrome. For radiation protection reasons, the dose for a radiotherapy series should not exceed 3.0 Gy. (orig.)

  3. Improved clinical outcome after invasive management of patients with recent myocardial infarction and proven myocardial viability: primary results of a randomized controlled trial (VIAMI-trial

    Directory of Open Access Journals (Sweden)

    van Loon Ramon B

    2012-01-01

    Full Text Available Abstract Background Patients with ST-elevation myocardial infarction (STEMI not treated with primary or rescue percutaneous coronary intervention (PCI are at risk for recurrent ischemia, especially when viability in the infarct-area is present. Therefore, an invasive strategy with PCI of the infarct-related coronary artery in patients with viability would reduce the occurrence of a composite end point of death, reinfarction, or unstable angina (UA. Methods Patients admitted with an (subacute myocardial infarction, who were not treated by primary or rescue PCI, and who were stable during the first 48 hours after the acute event, were screened for the study. Eventually, we randomly assigned 216 patients with viability (demonstrated with low-dose dobutamine echocardiography to an invasive or a conservative strategy. In the invasive strategy stenting of the infarct-related coronary artery was intended with abciximab as adjunct treatment. Seventy-five (75 patients without viability served as registry group. The primary endpoint was the composite of death from any cause, recurrent myocardial infarction (MI and unstable angina at one year. As secondary endpoint the need for (repeat revascularization procedures and anginal status were recorded. Results The primary combined endpoint of death, recurrent MI and unstable angina was 7.5% (8/106 in the invasive group and 17.3% (19/110 in the conservative group (Hazard ratio 0.42; 95% confidence interval [CI] 0.18-0.96; p = 0.032. During follow up revascularization-procedures were performed in 6.6% (7/106 in the invasive group and 31.8% (35/110 in the conservative group (Hazard ratio 0.18; 95% CI 0.13-0.43; p Conclusion We demonstrated that after acute MI (treated with thrombolysis or without reperfusion therapy patients with viability in the infarct-area benefit from a strategy of early in-hospital stenting of the infarct-related coronary artery. This treatment results in a long-term uneventful clinical

  4. Amyloid-β 11C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials

    Science.gov (United States)

    Schmidt, Mark E.; Margolin, Richard; Sperling, Reisa; Koeppe, Robert; Mason, Neale S.; Klunk, William E.; Mathis, Chester A.; Salloway, Stephen; Fox, Nick C.; Hill, Derek L.; Les, Andrea S.; Collins, Peter; Gregg, Keith M.; Di, Jianing; Lu, Yuan; Tudor, I. Cristina; Wyman, Bradley T.; Booth, Kevin; Broome, Stephanie; Yuen, Eric; Grundman, Michael; Brashear, H. Robert

    2015-01-01

    Objective: To evaluate the effects of bapineuzumab on brain β-amyloid (Aβ) burden using 11C-Pittsburgh compound B (11C-PiB)-PET. Methods: Two phase 3 clinical trials, 1 each in apolipoprotein APOE ε4 carriers and noncarriers, were conducted in patients with mild to moderate Alzheimer disease dementia. Bapineuzumab, an anti-Aβ monoclonal antibody, or placebo, was administered by IV infusion every 13 weeks for 78 weeks. PET substudies assessed change in brain fibrillar Aβ over 71 weeks using an 11C-PiB-PET standardized uptake value ratio (SUVr) global cortical average (GCA) comprising the average SUVr from 5 cortical regions of interest with cerebellar gray matter as the reference region. Results: A total of 115 carriers and 39 noncarriers were analyzed. The difference (δ) in mean baseline to 71 week change in 11C-PiB-PET GCA between bapineuzumab and placebo was significant in carriers (0.5 mg/kg vs placebo δ = −0.101; p = 0.004) and in pooled analyses of both carriers and noncarriers (0.5 mg/kg vs placebo δ = −0.068; p = 0.027; 1.0 mg/kg vs placebo δ = −0.133; p = 0.028) but not in the noncarrier trial separately. Analyses by individual region of interest and in mild disease yielded findings similar to the main trial results. Conclusions: The 11C-PiB-PET imaging results demonstrated reduction of fibrillar Aβ accumulation in patients with Alzheimer disease treated with bapineuzumab; however, as no clinical benefit was observed, the findings are consistent with the hypotheses that bapineuzumab may not have been initiated early enough in the disease course, the doses were insufficient, or the most critical Aβ species were inadequately targeted. PMID:26208959

  5. The European Ultrasonic Planetary Core Drill: Preliminary Results from Field Trials at the Haughton Mars Project

    Science.gov (United States)

    Worrall, K.; Timoney, R.; Li, X.; Harkness, P.; Lucas, M.

    2016-09-01

    This paper presents the findings of a recent field trip by the Ultrasonic Planetary Core Drill team to the Mars analog site at the Haughton Mars Project. Results of this trip are compared to results obtained drilling permafrost simulant in the lab.

  6. Radiotherapy for benign achillodynia. Long-term results of the Erlangen Dose Optimization Trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, Oliver J.; Jeremias, Carolin; Gaipl, Udo S.; Frey, Benjamin; Schmidt, Manfred; Fietkau, Rainer [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany)

    2015-12-15

    The aim of this study was to evaluate the long-term efficacy of two dose-fractionation schedules for radiotherapy of achillodynia. Between February 2006 and February 2010, 112 evaluable patients were recruited for this prospective trial. All patients received orthovoltage radiotherapy. One course consisted of 6 fractions/3 weeks. In the case of insufficient remission of pain after 6 weeks, a second series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after (early response), 6 weeks after (delayed response), and approximately 2 years after radiotherapy (long-term response) with a questionnaire-based visual analogue scale (VAS) and a comprehensive pain score (CPS). The median follow-up was 24 months (range, 11-56). The overall early, delayed, and long-term response rates for all patients were 84 %, 88 %, and 95 %, respectively. The mean VAS values before treatment for early, delayed, and long-term responses for the 0.5-Gy and 1.0-Gy groups were 55.7 ± 21.0 and 58.2 ± 23.5 (p = 0.53), 38.0 ± 23.2 and 30.4 ± 22.6 (p = 0.08), 35.5 ± 25.9 and 30.9 ± 25.4 (p = 0.52), and 11.2 ± 16.4 and 15.3 ± 18.9 (p = 0.16), respectively. The mean CPS values before treatment for early, delayed, and long-term responses were 8.2 ± 3.0 and 8.9 ± 3.3 (p = 0.24), 5.6 ± 3.1 and 5.4 ± 3.3 (p = 0.76), 4.4 ± 2.6 and 5.3 ± 3.8 (p = 0.58), and 2.2 ± 2.9 and 2.8 ± 3.3 (p = 0.51), respectively. No significant differences in long-term response quality between the two arms was found (p = 0.73). Radiotherapy is a very effective treatment for the management of benign achillodynia. For radiation protection, the dose for a radiotherapy series should not exceed 3.0 Gy. (orig.) [German] Ziel war die Untersuchung der Langzeiteffektivitaet zweier Dosisfraktionierungskonzepte bei der Strahlentherapie von Patienten mit Achillodynie. Zwischen 2006 und 2010 wurden 112 auswertbare

  7. Radiotherapy for benign calcaneodynia. Long-term results of the Erlangen Dose Optimization (EDO) trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, Oliver J.; Jeremias, Carolin; Gaipl, Udo S.; Frey, Benjamin; Schmidt, Manfred; Fietkau, Rainer [University Hospital Erlangen, Dept. of Radiation Oncology, Erlangen (Germany)

    2014-07-15

    The goal of this work was to evaluate the long-term efficacy of two dose-fractionation schedules for radiotherapy of calcaneodynia. Between February 2006 and February 2010, 457 evaluable patients were recruited for this prospective trial. All patients received orthovoltage radiotherapy. One course consisted of 6 fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, right after (early response), 6 weeks (delayed response), and approximately 2.5 years after radiotherapy (long-term response) with a questionnaire-based visual analogue scale (VAS) and a comprehensive pain score (CPS). The median follow-up was 32 months (range 9-57 months). The overall early, delayed, and long-term response rates for all patients were 87, 88, and 95 %. The mean VAS values before treatment, for early, delayed, and long-term response for the 0.5 and 1.0 Gy groups were 65.5 ± 22.1 and 64.0 ± 20.5 (p = 0.19), 34.8 ± 24.7 and 39.0 ± 26.3 (p = 0.12), 25.1 ± 26.8 and 28.9 ± 26.8 (p = 0.16), and 16.3 ± 24.3 and 14.1 ± 19.7 (p = 0.68). The mean CPS values before treatment, for early, delayed, and log-term response were 10.1 ± 2.7 and 10.0 ± 3.0 (p = 0.78), 5.6 ± 3.7 and 6.0 ± 3.9 (p = 0.34), 4.0 ± 4.1 and 4.3 ± 3.6 (p = 0.26), and 2.1 ± 3.3 and 2.3 ± 3.2 (p = 0.34), respectively. No significant differences in long-term response quality between the two arms were found (p = 0.50). Radiotherapy is a very effective treatment for the management of benign calcaneodynia. For radiation protection reasons, the dose for a RT series should not exceed 3.0 Gy. (orig.) [German] Untersuchung der Langzeiteffektivitaet zweier Dosisfraktionierungskonzepte bei der Strahlentherapie von Patienten mit Calcaneodynie. Zwischen 2006 und 2010 wurden 457 auswertbare Patienten in diese prospektive und randomisierte Phase

  8. The effect of educational intervention on intercultural communication: results of a randomised controlled trial

    NARCIS (Netherlands)

    H. Harmsen; L. Meeuwesen; S. Thomas (Siep); G. Dorrenboom; D. Pinto; M.A. Bruijnzeels (Marc); R.M.D. Bernsen (Roos)

    2005-01-01

    textabstractBACKGROUND: Due to worldwide migration to Western countries, physicians are increasingly encountering patients with different ethnic backgrounds. Communication problems can arise as a result of differences in cultural backgrounds and poor language proficiency. AIMS: To

  9. Assessing adherence in the CAPRISA 004 tenofovir gel HIV prevention trial: results of a nested case-control study.

    Science.gov (United States)

    MacQueen, Kathleen M; Weaver, Mark A; van Loggerenberg, Francois; Succop, Stacey; Majola, Nelisle; Taylor, Doug; Karim, Quarraisha Abdool; Karim, Salim Abdool

    2014-05-01

    Adherence undeniably impacts product effectiveness in microbicide trials, but the connection has proven challenging to quantify using routinely collected behavioral data. We explored this relationship using a nested case-control study in the CAPRISA 004 Tenofovir (TFV) gel HIV prevention trial. Detailed 3-month recall data on sex events, condom and gel use were collected from 72 incident cases and 205 uninfected controls. We then assessed how the relationship between self-reported adherence and HIV acquisition differed between the TFV and placebo gel groups, an interaction effect that should exist if effectiveness increases with adherence. The CAPRISA 004 trial determined that randomization to TFV gel was associated with a significant reduction in risk of HIV acquisition. In our nested case-control study, however, we did not observe a meaningful decrease in the relative odds of infection-TFV versus placebo-as self-reported adherence increased. To the contrary, exploratory sub-group analysis of the case-control data identified greater evidence for a protective effect of TFV gel among participants reporting less than 80 % adherence to the protocol-defined regimen (odds ratio (OR) 0.30; 95 % CI 0.11-0.78) than among those reporting ≥ 80 % adherence (Odds Ratio 0.81; 95 % CI 0.34-1.92). The small number of cases may have inhibited our ability to detect the hypothesized interaction between adherence and effectiveness. Nonetheless, our results re-emphasize the challenges faced by investigators when adherence may be miss-measured, miss-reported, or confounded with the risk of HIV. PMID:24647763

  10. Design and initial results of a multi-phase randomized trial of ceftriaxone in amyotrophic lateral sclerosis.

    Directory of Open Access Journals (Sweden)

    James D Berry

    Full Text Available Ceftriaxone increases expression of the astrocytic glutamate transporter, EAAT2, which might protect from glutamate-mediated excitotoxicity. A trial using a novel three stage nonstop design, incorporating Phases I-III, tested ceftriaxone in ALS. Stage 1 determined the cerebrospinal fluid pharmacokinetics of ceftriaxone in subjects with ALS. Stage 2 evaluated safety and tolerability for 20-weeks. Analysis of the pharmacokinetics, tolerability, and safety was used to determine the ceftriaxone dosage for Stage 3 efficacy testing.In Stage 1, 66 subjects at ten clinical sites were enrolled and randomized equally into three study groups receiving intravenous placebo, ceftriaxone 2 grams daily or ceftriaxone 4 grams daily divided BID. Participants provided serum and cerebrospinal fluid for pharmacokinetic analysis on study day 7. Participants continued their assigned treatment in Stage 2. The Data and Safety Monitoring Board (DSMB reviewed the data after the last participants completed 20 weeks on study drug.Stage 1 analysis revealed linear pharmacokinetics, and CSF trough levels for both dosage levels exceeding the pre-specified target trough level of 1 µM (0.55 µg/mL. Tolerability (Stages 1 and 2 results showed that ceftriaxone at dosages up to 4 grams/day was well tolerated at 20 weeks. Biliary adverse events were more common with ceftriaxone but not dose-dependent and improved with ursodeoxycholic (ursodiol therapy.The goals of Stages 1 and 2 of the ceftriaxone trial were successfully achieved. Based on the pre-specified decision rules, the DSMB recommended the use of ceftriaxone 4 g/d (divided BID for Stage 3, which recently closed.ClinicalTrials.gov NCT00349622.

  11. A randomised controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with bacterial vaginosis: preliminary results

    Directory of Open Access Journals (Sweden)

    Krauss-Silva Leticia

    2011-11-01

    Full Text Available Abstract Background Bacterial vaginosis increases the risk of spontaneous preterm delivery at less than 34 weeks of gestation. Objective The purpose of this study was to evaluate the efficacy of the early administration of selected lactobacilli strains (probiotics to pregnant women with asymptomatic bacterial vaginosis/intermediate-degree infections to prevent spontaneous premature delivery and associated neonatal morbidity. Methods/Design Asymptomatic pregnant women at less than 20 weeks of gestation, with no indication of elective preterm delivery, with a vaginal pH ≥ 4.5 and Nugent score > 3 were randomly assigned to the placebo or intervention group (oral administration of selected lactobacilli up to the 24th to 26th week of gestation. The randomisation was stratified for the history of premature delivery (HPD and blocked. The allocation was concealed, and the participating health professionals and patients were blinded. The primary outcome was preterm delivery ( Results In total, 4,204 pregnant women were screened; 320 and 324 individuals were respectively randomly assigned to the placebo and intervention groups, and 62% finished the trial. None of the randomised patients were lost to follow-up. For the non-HPD stratum, the intent-to-treat relative risks of spontaneous premature birth at Conclusions The efficacy of the tested probiotics to prevent preterm delivery among women without a history of preterm delivery was not determined because the study sample was insufficient to estimate statistically significant intent-to-treat effects; additional studies are needed to evaluate this intervention among these women. Trial registration Trial registration at NIH register: NCT00303082. Sources of funding: the Brazilian Health Ministry and the State of Rio de Janeiro Research Foundation.

  12. The “Healthy Habits, Healthy Girls” randomized controlled trial for girls: study design, protocol, and baseline results

    Directory of Open Access Journals (Sweden)

    Ana Carolina Barco Leme

    2015-07-01

    Full Text Available The purpose of this article is to describe the study design, protocol, and baseline results of the “Healthy Habits, Healthy Girls” program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices. There were no significant differences between the groups for most of the variables, except age (p = 0.000 and waist circumference (p = 0.014. The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

  13. Late sodium current block for drug-induced long QT syndrome: Results from a prospective clinical trial.

    Science.gov (United States)

    Johannesen, L; Vicente, J; Mason, J W; Erato, C; Sanabria, C; Waite-Labott, K; Hong, M; Lin, J; Guo, P; Mutlib, A; Wang, J; Crumb, W J; Blinova, K; Chan, D; Stohlman, J; Florian, J; Ugander, M; Stockbridge, N; Strauss, D G

    2016-02-01

    Drug-induced long QT syndrome has resulted in many drugs being withdrawn from the market. At the same time, the current regulatory paradigm for screening new drugs causing long QT syndrome is preventing drugs from reaching the market, sometimes inappropriately. In this study, we report the results of a first-of-a-kind clinical trial studying late sodium (mexiletine and lidocaine) and calcium (diltiazem) current blocking drugs to counteract the effects of hERG potassium channel blocking drugs (dofetilide and moxifloxacin). We demonstrate that both mexiletine and lidocaine substantially reduce heart-rate corrected QT (QTc) prolongation from dofetilide by 20 ms. Furthermore, all QTc shortening occurs in the heart-rate corrected J-Tpeak (J-Tpeak c) interval, the biomarker we identified as a sign of late sodium current block. This clinical trial demonstrates that late sodium blocking drugs can substantially reduce QTc prolongation from hERG potassium channel block and assessment of J-Tpeak c may add value beyond only assessing QTc. PMID:26259627

  14. Knowledge of Results after Good Trials Enhances Learning in Older Adults

    Science.gov (United States)

    Chiviacowsky, Suzete; Wulf, Gabriele; Wally, Raquel; Borges, Thiago

    2009-01-01

    In recent years, some researchers have examined motor learning in older adults. Some of these studies have specifically looked at the effectiveness of different manipulations of extrinsic feedback, or knowledge of results (KR). Given that many motor tasks may already be more challenging for older adults compared to younger adults, making KR more…

  15. Gestational weight gain: results from the Delta Healthy Sprouts comparative impact trial

    Science.gov (United States)

    Introduction. Delta Healthy Sprouts was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of Southern African American women and their infants. Results pertaining to the primary outcome, gestational weight gain, are reporte...

  16. Web-enabled Conversational Interactions as a Means to Improve Cognitive Functions: Results of a 6-Week Randomized Controlled Trial

    Science.gov (United States)

    Dodge, Hiroko H.; Zhu, Jian; Mattek, Nora; Bowman, Molly; Ybarra, Oscar; Wild, Katherine; Loewenstein, David A.; Kaye, Jeffrey A.

    2015-01-01

    INTRODUCTION Increasing social interaction could be a promising intervention for improving cognitive function. We examined the feasibility of a randomized controlled trial to assess whether conversation-based cognitive stimulation, through personal computers, webcams, and a user-friendly interactive Internet interface had high adherence and a positive effect on cognitive functions among older adults without dementia. METHODS Daily 30 minute face-to-face communications were conducted over a 6-week trial period in the intervention group. The control group had only a weekly telephone interview. Cognitive status of normal and MCI subjects was operationally defined as Global Clinical Dementia Rating (CDR) = 0 and 0.5, respectively. Age, sex, education, Mini-Mental State Exam and CDR score were balancing factors in randomization. Subjects were recruited using mass-mailing invitations. Pre-post differences in cognitive test scores and loneliness scores were compared between control and intervention groups using linear regression models. RESULTS Eighty-three subjects participated (intervention: n=41, control: n=42). Their mean (std) age was 80.5 (6.8) years. Adherence to the protocol was high; there was no dropout and mean % of days completed out of the targeted trial days among the intervention group was 89% (range: 77%–100%). Among the cognitively intact participants, the intervention group improved more than the control group on a semantic fluency test (p=0.003) at the post-trial assessment and a phonemic fluency test (p=0.004) at the 18th week assessments. Among those with MCI, a trend (p=0.04) of improved psychomotor speed was observed in the intervention group. DISCUSSION Daily conversations via user-friendly Internet communication programs demonstrated high adherence. Among cognitively intact, the intervention group showed greater improvement in tests of language-based executive functions. Increasing daily social contacts through communication technologies could

  17. Intelligent speed assistance for serious speeders: the results of the Dutch Speedlock trial.

    Science.gov (United States)

    van der Pas, J W G M; Kessels, J; Veroude, B D G; van Wee, B

    2014-11-01

    One of the most important policy questions regarding Intelligent Speed Assistance (ISA) is whether or not it should be implemented, and if so how. In 2010 the Dutch Ministry of Infrastructure and the Environment decided to perform a field operational test to investigate the possibility of using ISA as a penalty system for serious speed offenders. This paper presents the results of this research, focusing on the effects on road safety. The results show that the two types of ISA systems that were tested have a huge effect on driver behavior and have the potential to improve road safety by reducing the level of speeding, mean speed, as well as the standard deviation of speed. However, the users show little sign of learning after the systems are turned off. Moreover, the serious offenders frequently use the emergency button to override the system which might seriously affect the efficacy of the system. PMID:25016458

  18. Effect of Acupressure on Non-stress Test (NST Results: A Randomized-Controlled Trial Study

    Directory of Open Access Journals (Sweden)

    Masoume Pirhadi

    2015-10-01

    Full Text Available BackgroundPregnancy and delivery are among the most stressful events in women’s life . Breech presentation is defined as a fetus in a longitudinal lie with the buttocks or feet closest to the cervix. This occurs in 3-4% of all deliveries.The risk for perinatal mortality was 1 in 300 for planned breech deliveries.Some conventional non-surgical therapies for breech presentation are available. acupoint (BL67 stimulations are commonly used for the correction of breech presentation. The present study aimed to evaluate the effect of acupressure on fetal wellbeing test results.MethodThis study is a clinical trialthat was conducted in one group and the two-steps.Participantswere pregnant women (primigravida who were 35 to 18 years that refer to Shahid Beheshti hospital in Isfahan in 2013 to receive routine prenatal care.The 32 pregnant women (32-36 weeks were randomly selected.They were stimulated immediately after the first Non stress test and before the second test.The researchers’ evaluated and analyzed variables using SPSS software version 20.FindingsMean (SD age of the subjects was 24/7±2/8 and 93/8% of them was housekeeper. The frequency of reactive Non Stress Test (NST was same before and after stimulation. The mean time of the tests’ result was decreased after stimulation significantly ( p-value=0.048. ConclusionsAlthough fetal non-stress test result wasn’t influenced by acupressure but this intervention led to shorter testing time to achieve results. In other words, after the intervention, the time it takes to reach a reactive fetal non-stress test is about 2/7 minutes less than the time without intervention.

  19. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial

    OpenAIRE

    Siminiak, Tomasz; Wu, Justina C.; Haude, Michael; Hoppe, Uta C.; Sadowski, Jerzy; Lipiecki, Janusz; Fajadet, Jean; Shah, Amil M.; Feldman, Ted; Kaye, David M; Goldberg, Steven L.; Levy, Wayne C.; Solomon, Scott D.; Reuter, David G.

    2012-01-01

    Aims Functional mitral regurgitation (FMR) contributes to morbidity and mortality in heart failure (HF) patients. The aim of this study was to determine whether percutaneous mitral annuloplasty could safely and effectively reduce FMR and yield durable long-term clinical benefit. Methods and results The impact of mitral annuloplasty (Carillon Mitral Contour System) was evaluated in HF patients with at least moderate FMR. Patients in whom the device was placed then acutely recaptured for clinic...

  20. Results from a trial of an unsupported internet intervention for depressive symptoms

    Directory of Open Access Journals (Sweden)

    Yan Leykin

    2014-10-01

    Full Text Available Internet interventions provide an option for those who either cannot or choose not to engage with traditional treatments. Most research on internet interventions involves guided or supported interventions. However, unsupported interventions offer considerably more scalability and cost-effectiveness, which makes them attractive for large-scale implementation. In this study, 309 participants recruited via Google AdWords entered an unsupported cognitive–behavioral internet intervention for depressive symptoms. To maximize the ecological validity of the study, participants received no incentives or live contact with study personnel. Furthermore, the study was open to individuals at any level of depressive symptoms, and all participants received the active intervention. The main outcome measures were depressive symptom level and self-efficacy in managing depressive symptoms. At follow-up, depression scores were significantly lower than baseline scores at each follow-up point (1, 2, 4, and 7 months, with pre–post effect sizes ranging from medium to large. Follow-up depression self-efficacy scores were significantly higher than baseline scores at each follow-up point, with pre–post effect sizes in the medium range. The results remained significant when analyzing only participants with depression scores indicative of a presence of a major depressive episode; results likewise remained significant when employing the conservative last observation carried forward convention, even in the presence of high attrition observed in this study. The results illustrate the potential of unsupported internet intervention to address the health needs of the global community.

  1. Trial protocol and preliminary results for a cluster randomised trial of behavioural support versus brief advice for smoking cessation in adolescents

    Directory of Open Access Journals (Sweden)

    Stanton Alan

    2010-12-01

    Full Text Available Abstract Background Many young people report they want to stop smoking and have tried to do so, but most of their quit attempts fail. For adult smokers, there is strong evidence that group behavioural support enhances quit rates. However, it is uncertain whether group behavioural support enhances abstinence in young smokers trying to quit. Findings A cluster randomised trial for young people trying to stop smoking to compare the efficacy of a school-based 9 week intensive group behavioural support course versus a school-based 7 week brief advice only course. Participants were assessed for evidence of tobacco addiction and nicotine replacement therapy (NRT was used if it was deemed appropriate by the therapist. Both types of course aimed to recruit approximately one hundred participants from approximately ten schools. The primary outcome was successful quitting at 4 weeks after quit day judged according to the Russell standard. Had the trial been completed, abstinence at 6 months after quit day and the relationships between successful quit attempts and 1 psychological assessments of dependence prior to quitting 2 salivary cotinine concentration prior to quitting and 3 sociodemographic characteristics would also have been assessed. The proportion of participants who stopped smoking in each arm of the trial were compared using Chi square tests. The trial was stopped shortly after it had started because funding to support the therapists running the stop smoking group behavioural support programme was withdrawn. Only three stop smoking courses were completed (two group support courses and one brief advice pharmacotherapy course. Seventeen participants in total entered the trial. At the end of the courses, one participant (10% attending the group support programme had stopped smoking and no participant attending the brief advice programme had stopped smoking. Discussion The trial was stopped so we were unable to determine whether group support helped

  2. Looking inside the black box: results of a theory-based process evaluation exploring the results of a randomized controlled trial of printed educational messages to increase primary care physicians' diabetic retinopathy referrals [Trial registration number ISRCTN72772651

    OpenAIRE

    J.M. Grimshaw; Presseau, J.; Tetroe, J.; Eccles, M. P.; Francis, J.; Godin, G; Graham, I.D.; Hux, J E; Johnston, M.; Legare, F.; Lemyre, L; Robinson, N; Zwarenstein, M

    2014-01-01

    Background Theory-based process evaluations conducted alongside randomized controlled trials provide the opportunity to investigate hypothesized mechanisms of action of interventions, helping to build a cumulative knowledge base and to inform the interpretation of individual trial outcomes. Our objective was to identify the underlying causal mechanisms in a cluster randomized trial of the effectiveness of printed educational materials (PEMs) to increase referral for diabetic retinopathy scree...

  3. Angiographic findings after supplementation with Heracleum persicum extract: Results of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Yunes Panahi

    2015-01-01

    Full Text Available Background: Heracleum persicum is a common dietary spice with several traditional medicinal properties important for cardiovascular health including antioxidant, hypolipidemic, and anti-inflammatory effects. This study explored the effects of supplementation with H. persicum fruit on the angiographic findings of patients with minimal coronary artery disease (CAD. Methods: Subjects who were diagnosed with 0.05. Similarly, there was no significant difference between the study groups in terms of disease progression and chest pain score (P > 0.05. Conclusions: The present results do not support any clinically significant benefit of supplementation with H. persicum extract on the angiographic findings of in patients with minimal CAD.

  4. The efficacy of duloxetine: A comprehensive summary of results from MMRM and LOCF_ANCOVA in eight clinical trials

    Directory of Open Access Journals (Sweden)

    Watkin John G

    2004-09-01

    Full Text Available Abstract Background A mixed-effects model repeated measures approach (MMRM was specified as the primary analysis in the Phase III clinical trials of duloxetine for the treatment of major depressive disorder (MDD. Analysis of covariance using the last observation carried forward approach to impute missing values (LOCF_ANCOVA was specified as a secondary analysis. Previous research has shown that MMRM and LOCF_ANCOVA yield identical endpoint results when no data are missing, while MMRM is more robust to biases from missing data and thereby provides superior control of Type I and Type II error compared with LOCF_ANCOVA. We compared results from MMRM and LOCF_ANCOVA analyses across eight clinical trials of duloxetine in order to investigate how the choice of primary analysis may influence interpretations of efficacy. Methods Results were obtained from the eight acute-phase clinical trials that formed the basis of duloxetine's New Drug Application for the treatment of MDD. All 202 mean change analyses from the 20 rating scale total scores and subscales specified a priori in the various protocols were included in the comparisons. Results In 166/202 comparisons (82.2%, MMRM and LOCF_ANCOVA agreed with regard to the statistical significance of the differences between duloxetine and placebo. In 25/202 cases (12.4%, MMRM yielded a significant difference when LOCF_ANCOVA did not, while in 11/202 cases (5.4%, LOCF_ANCOVA produced a significant difference when MMRM did not. In 110/202 comparisons (54.4% the p-value from MMRM was lower than that from LOCF_ANCOVA, while in 69/202 comparisons (34.2%, the p-value from LOCF_ANCOVA was lower than that from MMRM. In the remaining 23 comparisons (11.4%, the p-values from LOCF_ANCOVA and MMRM were equal when rounded to the 3rd decimal place (usually as a result of both p-values being 17 total score, the primary outcome in all studies, MMRM yielded 9/12 (75% significant contrasts, compared with 6/12 (50% for LOCF

  5. Characterization of a Test for Invasive Breast Cancer Using X-ray Diffraction of Hair - Results of a Clinical Trial

    Directory of Open Access Journals (Sweden)

    Gary L. Corino

    2009-11-01

    Full Text Available Objective: To assess the performance of a test for breast cancer utilizing synchrotron x-ray diffraction analysis of scalp hair from women undergoing diagnostic radiology assessment. Design and Setting: A double-blinded clinical trial of women who attended diagnostic radiology clinics in Australia. Patients: 1796 women referred for diagnostic radiology, with no previous history of cancer. Main Outcome Measures: Sensitivity, specificity and accuracy of the hair test analysis compared to the gold standard of imaging followed by biopsy where indicated. Results: The hair-based assay had an overall accuracy of >77% and a negative predictive value of 99%. For all women, the sensitivity of both mammography and x-ray diffraction alone was 64%, but when used together the sensitivity rose to 86%. The sensitivity of the hair test for women under the age of 70 was 74%. Conclusion: In this large population trial the association between the presence of breast cancer and an altered hair fibre X-ray diffraction pattern previously reported has been confirmed. It appears that mammography and X-ray diffraction of hair detect different populations of breast cancers, and are synergistic when used together.

  6. A 20-week program of resistance or concurrent exercise improves symptoms of schizophrenia: results of a blind, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bruna Andrade e Silva

    2015-01-01

    Full Text Available Objective:To evaluate the effects of 20 weeks of resistance and concurrent training on psychotic and depressive symptoms, quality of life outcomes, and serum IGF-1, IGFBP-3, and brain-derived neurotrophic factor (BDNF concentrations in patients with schizophrenia.Methods:In this blind, randomized controlled clinical trial, 34 patients with schizophrenia were assigned to one of three groups: control (CTRL, n=13, resistance exercise (RESEX, n=12, or concurrent exercise (CONCEX, n=9. Symptoms, quality of life, strength, and other variables were assessed.Results:A significant time-by-group interaction was found for the RESEX and CONCEX groups on the Positive and Negative Syndrome Scale (PANSS total score for disease symptoms (p = 0.007, positive symptoms (p = 0.003, and on the arm extension one-repetition maximum (1RM test (p = 0.016. In addition, significant improvements on negative symptoms (p = 0.027, on the role-physical domain of the Short Form-36 Health Survey (p = 0.019, and on the chest press 1RM test (p = 0.040 were observed in the RESEX group. No changes were observed for the other variables investigated.Conclusions:In this sample of patients with schizophrenia, 20 weeks of resistance or concurrent exercise program improved disease symptoms, strength, and quality of life. ClinicalTrials.gov: NCT01674543.

  7. Can multiple lifestyle behaviours be improved in people with familial hypercholesterolemia? Results of a parallel randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Karen Broekhuizen

    Full Text Available OBJECTIVE: To evaluate the efficacy of an individualised tailored lifestyle intervention on physical activity, dietary intake, smoking and compliance to statin therapy in people with Familial Hypercholesterolemia (FH. METHODS: Adults with FH (n = 340 were randomly assigned to a usual care control group or an intervention group. The intervention consisted of web-based tailored lifestyle advice and face-to-face counselling. Physical activity, fat, fruit and vegetable intake, smoking and compliance to statin therapy were self-reported at baseline and after 12 months. Regression analyses were conducted to examine between-group differences. Intervention reach, dose and fidelity were assessed. RESULTS: In both groups, non-significant improvements in all lifestyle behaviours were found. Post-hoc analyses showed a significant decrease in saturated fat intake among women in the intervention group (β = -1.03; CI -1.98/-0.03. In the intervention group, 95% received a log on account, of which 49% logged on and completed one module. Nearly all participants received face-to-face counselling and on average, 4.2 telephone booster calls. Intervention fidelity was low. CONCLUSIONS: Individually tailored feedback is not superior to no intervention regarding changes in multiple lifestyle behaviours in people with FH. A higher received dose of computer-tailored interventions should be achieved by uplifting the website and reducing the burden of screening questionnaires. Counsellor training should be more extensive. TRIAL REGISTRATION: Dutch Trial Register NTR1899.

  8. Different gene expression profiles in normo- and dyslipidemic men after fish oil supplementation: results from a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Schmidt Simone

    2012-08-01

    Full Text Available Abstract Background Epidemiological studies have suggested the benefits of omega-3 polyunsaturated fatty acids (n-3 PUFAs on cardiovascular health, but only limited data are available describing n-3 PUFA regulated pathways in humans. The aim of this study was to investigate the effects of n-3 PUFA administration on whole genome expression profiles in the blood of normo- and dyslipidemic subjects. Methods Differentially expressed genes were detected after four hours, one week and twelve weeks of supplementation with either fish oil (FO or corn oil in normo- and dyslipidemic men using whole genome microarrays. Results Independent of the oil, a significantly higher number of genes was regulated in dyslipidemic subjects compared to normolipidemic subjects. Pathway analyses discovered metabolisms dominantly affected by FO after twelve weeks of supplementation, including the lipid metabolism, immune system and cardiovascular diseases. Several pro-inflammatory genes, in particular, were down-regulated in dyslipidemic subjects, indicating the immune-modulatory and anti-inflammatory capability of FO and its bioactive FAs, eicosapentaenoic acid and docosahexaenoic acid. Conclusions This is the first study showing significant differences in gene expression profiles between normo- and dyslipidemic men after FO supplementation. Further studies need to clarify the exact role of n-3 PUFAs in pathways and metabolisms which were identified as being regulated after FO supplementation in this study. Trial registration ClinicalTrials.gov (ID: NCT01089231

  9. Electrokinetic remediation of plutonium-contaminated nuclear site wastes: results from a pilot-scale on-site trial.

    Science.gov (United States)

    Agnew, Kieran; Cundy, Andrew B; Hopkinson, Laurence; Croudace, Ian W; Warwick, Phillip E; Purdie, Philip

    2011-02-28

    This paper examines the field-scale application of a novel low-energy electrokinetic technique for the remediation of plutonium-contaminated nuclear site soils, using soil wastes from the Atomic Weapons Establishment (AWE) Aldermaston site, Berkshire, UK as a test medium. Soils and sediments with varying composition, contaminated with Pu through historical site operations, were electrokinetically treated at laboratory-scale with and without various soil pre-conditioning agents. Results from these bench-scale trials were used to inform a larger on-site remediation trial, using an adapted containment pack with battery power supply. 2.4 m(3) (ca. 4t onnes) of Pu-contaminated soil was treated for 60 days at a power consumption of 33 kWh/m(3), and then destructively sampled. Radiochemical data indicate mobilisation of Pu in the treated soil, and migration (probably as a negatively charged Pu-citrate complex) towards the anodic compartment of the treatment cell. Soil in the cathodic zone of the treatment unit was remediated to a level below free-release disposal thresholds (1.7 Bq/g, or remediation of radioactively contaminated soils and wastes which can be operated remotely on working sites, with minimal disruption to site infrastructure or operations. PMID:21227583

  10. Electrokinetic remediation of plutonium-contaminated nuclear site wastes: Results from a pilot-scale on-site trial

    Energy Technology Data Exchange (ETDEWEB)

    Agnew, Kieran [AWE PLC, Aldermaston, Berks RG7 4PR (United Kingdom); Cundy, Andrew B., E-mail: A.Cundy@brighton.ac.uk [School of Environment and Technology, University of Brighton, Lewes Road, Brighton BN2 4GJ (United Kingdom); Hopkinson, Laurence [School of Environment and Technology, University of Brighton, Lewes Road, Brighton BN2 4GJ (United Kingdom); Croudace, Ian W.; Warwick, Phillip E. [GAU-Radioanalytical Laboratories, School of Ocean and Earth Science, National Oceanography Centre, European Way, Southampton SO14 3ZH (United Kingdom); Purdie, Philip [AWE PLC, Aldermaston, Berks RG7 4PR (United Kingdom)

    2011-02-28

    This paper examines the field-scale application of a novel low-energy electrokinetic technique for the remediation of plutonium-contaminated nuclear site soils, using soil wastes from the Atomic Weapons Establishment (AWE) Aldermaston site, Berkshire, UK as a test medium. Soils and sediments with varying composition, contaminated with Pu through historical site operations, were electrokinetically treated at laboratory-scale with and without various soil pre-conditioning agents. Results from these bench-scale trials were used to inform a larger on-site remediation trial, using an adapted containment pack with battery power supply. 2.4 m{sup 3} (ca. 4 tonnes) of Pu-contaminated soil was treated for 60 days at a power consumption of 33 kW h/m{sup 3}, and then destructively sampled. Radiochemical data indicate mobilisation of Pu in the treated soil, and migration (probably as a negatively charged Pu-citrate complex) towards the anodic compartment of the treatment cell. Soil in the cathodic zone of the treatment unit was remediated to a level below free-release disposal thresholds (1.7 Bq/g, or <0.4 Bq/g above background activities). The data show the potential of this method as a low-cost, on-site tool for remediation of radioactively contaminated soils and wastes which can be operated remotely on working sites, with minimal disruption to site infrastructure or operations.

  11. The role of long-term doxycycline in patients of idiopathic pulmonaryfibrosis: The results of an open prospective trial

    Directory of Open Access Journals (Sweden)

    Bhattacharyya Parthasarathi

    2009-01-01

    Full Text Available Objective: To evaluate the effect of long term use of doxycycline in IPF patients. Materials and Methods: Patients of IPF, selected randomly from out patient services and diagnosed on the basis of HRCT chest, were put on doxycycline in an open prospective trial. They were followed up with monitoring of subjective well being along with measurement of pulse rate and arterial oxygen saturation at rest and after a fixed and certain exercise, forced vital capacity, six minutes walk test, St Georges Respiratory questionnaire, and serial chest X-rays. Results: Out of seven patients put on doxycycline, six of them continued the drug for a mean period of 531.43 (± 328.88 days. All the patients tolerated the drug well and had shown uniform subjective and overall objective improvement in all the parameters concerned; the change in the radiological parameter being statistically significant. Conclusion: Doxycycline merits an appropriate clinical trial in the management of idiopathic pulmonary fibrosis. This widely used and relatively safe drug can add a new dimension to the therapeutic regimen. However, further in-depth studies will be required to evaluate its role in the management of IPF.

  12. Sucralfate for radiation mucositis: results of a double-blind randomized trial

    International Nuclear Information System (INIS)

    Purpose: To determine if addition of the ulcer-coating polysaccharide sucralfate could improve symptomatic relief of radiation mucositis over a popular combination of antacid, diphenhydramine, and viscous lidocaine alone. Methods and Materials: A double-blind study was conducted in which nurses and pharmacists coded patient groups and distributed medication in a manner blinded to both the patients and physicians. Eligible patients receiving radiation to the head and neck and/or chest sites that included the esophagus were randomized to a standard combination of antacid, diphenhydramine, and viscous lidocaine vs. the same solution plus sucralfate. Eligible patients were those receiving >40 Gy at 1.8 Gy/fraction, one fraction/day, five fractions/week. Participating patients were stratified between chest, small field head and neck, and large field head and neck. The observations and smears for Candidiasis screening. Medication was prescribed when the patient became symptomatic and concomitant use of other locally effective nonstudy agents was not allowed. The ability to eat various consistency of foods was graded 0-5, with 5 indicating no compromise of ability to ingest a food compared to baseline. Statistical analysis included mean + SD for food and soreness scores, paired t-test, and two-way analyses of variance to evaluate effects of site and treatment group on the changes in scores. Results: Over 2 years, 111 patients were entered. Because some withdrew and others did not require medication, results are presented for evaluable patients in each category. Mild adverse effects from the medication solution (usually mouth discomfort) were reported by <10% of patients in each treatment group among 106 patients evaluable for toxicity. There was a comparable incidence of mild-moderate mucositis for the two treatment groups. Severe mucositis was noted in two patients of the standard medication group and none among patients receiving sucralfate. The groups were comparable

  13. A web application for moderation training: initial results of a randomized clinical trial.

    Science.gov (United States)

    Hester, Reid K; Delaney, Harold D; Campbell, William; Handmaker, Nancy

    2009-10-01

    Eighty-four heavy drinkers who responded to a newspaper recruitment advertisement were randomly assigned to receive either (a) training in a Moderate Drinking protocol via an Internet-based program (www.moderatedrinking.com) and use of the online resources of Moderation Management (MM; www.moderation.org) or (b) use of the online resources of MM alone. Follow-ups are being conducted at 3, 6, and 12 months. Results of the recently completed 3-month follow-up (86% follow-up) indicated both groups significantly reduced their drinking based on these variables: standard drinks per week, percent days abstinent, and mean estimated blood alcohol concentration (BAC) per drinking day. Both groups also significantly reduced their alcohol-related problems. Relative to the control group, the experimental group had better outcomes on percent days abstinent and log drinks per drinking day. These short-term outcome data provide evidence for the effectiveness of both the Moderate Drinking Web application and of the resources available online at MM in helping heavy drinkers reduce their drinking and alcohol-related problems. PMID:19339137

  14. Simple radiographic parameter predicts fracturing in metastatic femoral bone lesions: results from a randomised trial

    International Nuclear Information System (INIS)

    Background and purpose: In the randomised Dutch Bone Metastasis Study on the palliative effect of a single fraction (SF) of 8 Gy versus six fractions of 4 Gy on painful bone metastases, 14 fractures occurred in 102 patients with femoral metastases. Purpose of the present study was to identify lesional risk factors for fracturing and to evaluate the influence of the treatment schedule. Material and methods: Pretreatment radiographs of femoral metastases were collected. Three observers separately measured the lesions and scored radiographic characteristics. Results: Ten fractures occurred after median 7 weeks in 44 SF patients (23%) and four after median 20 weeks in 58 multiple fraction patients (7%) (UV, P=0.02). In 110 femoral metastases, an axial cortical involvement >30 mm significantly predicted fracturing (MV, P=0.02). Twelve out of 14 fractured lesions and 40 out of 96 non-fractured metastases had an axial cortical involvement >30 mm (negative predictive value, 97%). When correcting for the axial cortical involvement, the treatment schedule was not predictive anymore (MV, P=0.07). Conclusions: Fracturing of the femur mostly depended on the amount of axial cortical involvement of the metastasis. We recommend to treat femoral metastases with an axial cortical involvement ≤30 mm with an SF of 8 Gy for relief of pain. If the axial cortical involvement is >30 mm, prophylactic surgery should be performed to minimize the risk of pathological fracturing or, if the patient's condition is limited, irradiation to a higher total dose

  15. Sucralfate for radiation mucositis: results of a double-blind randomized trial

    International Nuclear Information System (INIS)

    Purpose: To determine if addition of the ulcer-coating polysaccharide sucralfate could improve symptomatic relief of radiation mucositis over a popular combination of Maalox, diphenhyrdramine and viscous lidocaine alone. Methods: A double-blind study was conducted in which nurses/pharmacists coded patient groups and distributed medication in a manner blinded to both the patients and physicians. Eligible patients receiving radiation to the head and neck and/or chest sites that included the esophagus were randomized to a standard combination of Maalox, diphenhydramime and viscous lidocaine verses the same solution plus sucralfate. Eligible patients were those receiving > 40 Gy at 1.8 Gy/fraction, 1 fraction/day, 5 fractions/week. Participating patients were stratified between chest, small field head and neck, and large field head and neck. Baseline information regarding use of tobacco, alcohol, and food intake was obtained prior to symptomatic mucositis. This was compared with similar information obtained weekly once symptoms occurred. The patients subjected evaluation of throat soreness and relief with medication was elicited as well as physician observations and smears for Candidiasis screening. Medication was prescribed when the patient became symptomatic and concomitant use of other locally effective non-study agents was not allowed. Subjective soreness was graded on a scale of 0-20 with 0 indicating no soreness and 20 designating severe soreness that compromised ability to swallow secretions. The ability to eat various consistency of foods was graded 0-5 with 5 indicating no compromise of ability to ingest a food compared to baseline. Statistical analysis included mean + S.D. for food and soreness scores, paired t-test and two-way analyses of variance to evaluate effects of site and treatment group on the changes in scores. Results: Over 2 years, 110 patients were entered. Since some withdrew and others did not require medication, results are presented for

  16. Risk stratification of patients with locally aggressive differentiated thyroid cancer. Results of the MSDS trial

    Energy Technology Data Exchange (ETDEWEB)

    Riemann, B.; Kraemer, J.A.; Schober, O. [Dept. of Nuclear Medicine, Univ. Hospital, Muenster (Germany); Schmid, K.W. [Inst. of Pathology and Neuropathology, Univ. Hospital of Essen, Univ. of Duisburg-Essen (Germany); Dralle, H. [Dept. of General Surgery, Univ. Halle-Wittenberg (Germany); Dietlein, M.; Schicha, H. [Dept. of Nuclear Medicine, Univ. Cologne (Germany); Sauerland, C. [Dept. of Medical Informatics and Biomathematics, Univ. Muenster (Germany); Frankewitsch, T. [IT-Center - Research and Education, Univ. Muenster (Germany)

    2010-07-01

    The Multicentre Study Differentiated Thyroid Cancer (MSDS) collective represents a well defined group of patients with locally aggressive thyroid carcinomas (pT4; AJCC/UICC 1997). The aim of the present study was to compare the survival of patients with minimum and extensive extrathyroidal growth according to the new AJCC/UICC TNM staging system 2009. Patients, methods: The follow-up data of 347 patients were analysed. Patients were reclassified according to the current AJCC/UICC 2009 classification. The event-free and overall survival was evaluated using Kaplan-Meier analysis. In addition, postoperative complications and status of disease were documented. Results: 327 patients were assigned to stage pT3 and 20 patients to stage pT4a, respectively. Median follow-up was 6.1 years (range 0.04-9.8 years). 92.5% of patients reached complete remission. There were 7.8% recurrences in the thyroid bed, in locoregional lymph nodes and/or in distant sites. The overall survival was >98% both in pT3 and pT4a patients (p = n. s.). In contrast, the event-free survival was significantly less favourable in pT4a patients (p < 0.001). Using multivariate analysis the following parameters were significant predictors of event-free survival: histological tumour type, degree of extrathyroidal extension and nodal metastasis (p < 0.05). Conclusions: The MSDS patients with locally aggressive differentiated thyroid cancer showed an excellent overall survival during a median follow-up of 6.1 years. According to the current AJCC/UICC 2009 classification, pT3 patients with minimal extrathyroidal extension revealed a significantly better event-free survival than pT4a patients with extensive extrathyroidal growth. (orig.)

  17. Healthy dietary interventions and lipoprotein (a plasma levels: results from the Omni Heart Trial.

    Directory of Open Access Journals (Sweden)

    Bernhard Haring

    Full Text Available Increased lipoprotein(a [Lp(a] levels are associated with atherosclerotic cardiovascular disease. Studies of dietary interventions on changes in Lp(a are sparse. We aimed to compare the effects of three healthy dietary interventions differing in macronutrient content on Lp(a concentration.Secondary analysis of a randomized, 3-period crossover feeding study including 155 (89 blacks; 66 whites individuals. Participants were given DASH-type healthy diets rich in carbohydrates [Carb], in protein [Prot] or in unsaturated fat [Unsat Fat] for 6 weeks each. Plasma Lp(a concentration was assessed at baseline and after each diet.Compared to baseline, all interventional diets increased mean Lp(a by 2 to 5 mg/dl. Unsat Fat increased Lp(a less than Prot with a difference of 1.0 mg/dl (95% CI, -0.5, 2.5; p = 0.196 in whites and 3.7 mg/dl (95% CI, 2.4, 5.0; p < 0.001 in blacks (p-value between races = 0.008; Unsat Fat increased Lp(a less than Carb with a difference of -0.6 mg/dl, 95% CI, -2.1, 0.9; p = 0.441 in whites and -1.5 mg/dl (95% CI, -0.2, -2.8; p = 0.021 in blacks (p-value between races = 0.354. Prot increased Lp(a more than Carb with a difference of 0.4 mg/dl (95% CI, -1.1, 1.9; p = 0.597 in whites and 2.2 mg/dl (95%CI, 0.9, 3.5; p = 0.001 in blacks (p-value between races = 0.082.Diets high in unsaturated fat increased Lp(a levels less than diets rich in carbohydrate or protein with greater changes in blacks than whites. Our results suggest that substitutions with dietary mono- and polyunsaturated fatty acids in healthy diets may be preferable over protein or carbohydrates with regards to Lp(a.Clinicaltrials.gov NCT00051350.

  18. RESULTS OF A PILOT CLINICAL TRIAL OF DENDRITICCELL BASED VACCINES FOR TREATMENT OF RECURRENT HERPESVIRUS INFECTION

    Directory of Open Access Journals (Sweden)

    O. Yu. Leplina

    2016-01-01

    Full Text Available Chronic recurrent infections caused by herpes simplex virus (HSV types 1 and 2 represent a serious medical and social challenge. Given an important role of immune system in surveillance of viral infections, an induced enhancement of antigen-specific immune response seems to be a promising approach to treatment of recurrent HSV infections, in particular, using dendritic cell (DCs vaccines. The present paper contains results of an open pilot study evaluating efficacy and safety of dendritic-cell vaccines in the patients with recurrent HSV infections. Twenty-nine patients including 14 persons with labial herpes, and 15, with genital herpes have been enrolled in this study. DCs were generated in presence of GM-CSF and IFNα and then loaded with recombinant viral proteins (HSV1gD or HSV2gD. These cells were applied in 2 rounds of vaccination performed within 9 months. Immunotherapy with DCs did not induce sufficient side effects, and was accompanied by more than two-fold decrease in relapse rate and increased length of remissions during the 9-month period of treatment. Later on, we revealed a reduced frequency of relapses, and a 3-fold increase in remission duration over the subsequent 6-month follow up. The clinical effect during the treatment and at later terms (a half-year observation was noted with both labial and genital herpes, as registered in the majority of patients, being associated with induction of antigen-specific proliferative response and normalization of reduced mitogenic responsiveness of mononuclear cells towards ConA. The patients’ survey at longer terms (more than 24 months has shown that the beneficial effect of immunotherapy, in terms of reduced relapse rates, was maintained in 77.8% of the respondents by 48 months (a median follow-up term. At this time, the antigen specific proliferative response was maintained in 66.7% of patients. The data obtained suggest that the dendritic-cell vaccines may be a promising approach to the

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

    Energy Technology Data Exchange (ETDEWEB)

    Appelt, Ane L., E-mail: ane.lindegaard.appelt@rsyd.dk [Department of Oncology, Vejle Hospital, Vejle (Denmark); Faculty of Health Sciences, University of Southern Denmark, Odense (Denmark); Vogelius, Ivan R. [Department of Radiation Oncology, Rigshospitalet, University of Copenhagen, Copenhagen (Denmark); Pløen, John; Rafaelsen, Søren R.; Lindebjerg, Jan; Havelund, Birgitte M. [Danish Colorectal Cancer Group South, Vejle Hospital, Vejle (Denmark); Bentzen, Søren M. [Division of Biostatistics and Bioinformatics, University of Maryland Greenebaum Cancer Center, and Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland (United States); Jakobsen, Anders [Faculty of Health Sciences, University of Southern Denmark, Odense (Denmark); Danish Colorectal Cancer Group South, Vejle Hospital, Vejle (Denmark)

    2014-09-01

    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.

  20. Ten year results of a randomised trial comparing two conservative treatment strategies for small size breast cancer

    Energy Technology Data Exchange (ETDEWEB)

    Mariani, L. [Istituto Nazionale per lo Studio e la Cura dei Tumori (INT), Biometry, Via Venezian 1, I-20133 Milan (Italy); Salvadori, B. [INT, Surgical Oncology C, Via Venezian 1, I-20133 Milan (Italy); Marubini, E. [Istituto Nazionale per lo Studio e la Cura dei Tumori (INT), Biometry, Via Venezian 1, I-20133 Milan (Italy); Conti, A.R.; Rovini, D.; Cusumano, F. [INT, Surgical Oncology C, Via Venezian 1, I-20133 Milan (Italy); Rosolin, T. [Istituto Nazionale per lo Studio e la Cura dei Tumori (INT), Biometry, Via Venezian 1, I-20133 Milan (Italy); Andreola, S. [INT, Pathology, Via Venezian 1, I-20133 Milan (Italy); Zucali, R. [INT, Radiotherapy A, Via Venezian 1, I-20133 Milan (Italy); Rilke, F. [Istituto Nazionale per lo Studio e la Cura dei Tumori (INT), Biometry, Via Venezian 1, I-20133 Milan (Italy); Veronesi, U. [European Institute of Oncology, Milan (Italy)

    1998-07-01

    We report the 10-year results of a randomised clinical trial in which two different breast conservation treatment strategies were compared in women with small, non-metastatic primary breast cancer: quadrantectomy, axillary dissection and radiotherapy (QUART) versus tumorectomy and axillary dissection followed by external radiotherapy and a boost with {sup 192}Ir implantation (TART). No second surgery was given to women with affected surgical margins. Axillary node positive women received adjuvant medical therapy. From 1985-1987, this trial accrued 705 patients, 360 in the QUART and 345 in the TART arm. Crude cumulative incidence curves for intrabreast tumour recurrence (IBTR) and metastases as first events and mortality curves in each of the two treatment arms were computed. A crude cumulative incidence curve of IBTR as a second event (in women who had already had a local recurrence) was also computed. The two groups were compared in terms of hazard for IBTR, metastases or death occurrence by using Cox regression models, both with and without adjustment for patient age, tumour size, number of metastatic axillary nodes and histology. Possible interactions between the aforementioned prognostic factors and the type of surgery were also investigated. The two groups were well matched for baseline patient and tumour characteristics, the only exception being resection margins, which were more often positive in the TART group. At the Cox model, a significant difference between groups was detected for IBTR (P<0.0001), but not for distant metastases and overall survival. In particular, 5- and 10-year estimates of crude cumulative incidence of IBTR were 4.7 and 7.4% in the QUART group, and 11.6 and 18.6% in the TART group. The difference was not substantially affected by patient or disease characteristics. Likewise, the status of resection margins in women who underwent TART treatment did not significantly influence the risk of occurrence of IBTRs. Finally, the rate of second

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

    International Nuclear Information System (INIS)

    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

  2. Endovascular therapy in acute ischemic stroke: The way forward after results from the IMS 3, SYNTHESIS and MR Rescue trials

    Directory of Open Access Journals (Sweden)

    Bijoy K Menon

    2013-01-01

    Full Text Available Endovascular therapy (EVT has gained vogue in the management of patients with acute stroke. Newer stent-retriever devices have led to better recanalization rates. In many centers, EVT is slowly being used as an add on to or in some instances, even as an alternative to intravenous tissue plasminogen activator (IV tPA. The publication of the results of the SYNTHESIS expansion, Interventional Management of Stroke III and Mechanical Retrieval Recanalization of Stroke Clots Using Embolectomy trials in 2013 has questioned the enthusiastic use of EVT in acute stroke. They demonstrate that EVT (using a variety of devices is no superior to IV tPA in the management of acute stroke. In the light of these controversial findings, we review the current status of EVT in the management of acute stroke.

  3. Preoperative radio-chemotherapy in early breast cancer patients: Long-term results of a phase II trial

    International Nuclear Information System (INIS)

    Purpose: This phase II trial aimed to investigate the efficacy of concurrent radio- (RT) and chemotherapy (CT) in the preoperative setting for operable, non-metastatic breast cancer (BC) not amenable to initial breast-conserving surgery (BCS). Patients and methods: From 2001 to 2003, 59 women were included. CT consisted of four cycles of 5-FU, 500 mg/m2/d, continuous infusion (d1–d5) and vinorelbine, 25 mg/m2 (d1 and d6). Starting concurrently with the second cycle, RT delivered 50 Gy to the breast and 46 Gy to the internal mammary and supra/infra-clavicular areas. Breast surgery and lymph node dissection were then performed. Adjuvant treatment consisted of a 16 Gy boost to the tumor bed after BCS, FEC (four cycles of fluorouracil 500 mg/m2, cyclophosphamide 500 mg/m2, and epirubicin 100 mg/m2, d1; d21) for pN1-3 and hormone-therapy for positive hormone receptors BC. Results: The in-breast pathological complete response rate was 27%. BCS was performed in 41 (69%) pts. Overall and distant-disease free survivals at 5 years were respectively 88% [95% CI 80–98] and 83% [95% CI 74–93] whereas locoregional and local controls were 90% [95% CI 82–97] and 97% [95% CI 92–100]. Late toxicity (CTCAE-V3) was assessed in 51 pts (86%) with a median follow-up of 7 years [5–8]. Four (8%) experienced at least one grade III toxicities (one telangectasia and three fibroses). Cosmetic results, assessed in 35 of the 41 pts (85%) who retained their breasts, were poor in four pts (11%). Conclusion: Preoperative concurrent administration of RT and CT is an effective regimen. Long-term toxicity is moderate. This association deserves further evaluations in prospective trials.

  4. Use and Outcomes of Antiarrhythmic Therapy in Patients with Atrial Fibrillation Receiving Oral Anticoagulation: Results from the ROCKET AF Trial

    Science.gov (United States)

    Steinberg, Benjamin A.; Hellkamp, Anne S.; Lokhnygina, Yuliya; Halperin, Jonathan L.; Breithardt, Günter; Passman, Rod; Hankey, Graeme J.; Patel, Manesh R.; Becker, Richard C.; Singer, Daniel E.; Hacke, Werner; Berkowitz, Scott D.; Nessel, Christopher C.; Mahaffey, Kenneth W.; Fox, Keith A.A.; Califf, Robert M.; Piccini, Jonathan P.

    2014-01-01

    Background Antiarrhythmic drugs (AAD) and anticoagulation are mainstays of atrial fibrillation (AF) treatment. Objective We aimed to study the use and outcomes of AAD therapy in anticoagulated AF patients. Methods Patients in the ROCKET AF trial (n=14,264) were grouped by AAD use at baseline: amiodarone, other AAD, or no AAD. Multivariable adjustment was performed to compare stroke, bleeding, and death across groups, as well as across treatment assignment (rivaroxaban or warfarin). Results Of 14,264 patients randomized, 1681 (11.8%) were treated with an AAD (1144 [8%] with amiodarone, 537 [3.8%] with other AADs). Amiodarone-treated patients were less-often female (38% vs. 48%), had more persistent AF (64% vs. 40%), and more concomitant heart failure (71% vs. 41%) than patients receiving other AADs. Patients receiving no AAD more closely-resembled amiodarone-treated patients. Time in therapeutic range was significantly lower in warfarin-treated patients receiving amiodarone versus no AAD (50% vs. 58%, p<0.0001). Compared with no AAD, neither amiodarone (adjusted HR 0.98, 95% CI 0.74–1.31, p=0.9) nor other AADs (adjusted HR 0.66, 95% CI 0.37–1.17, p=0.15) were associated with increased mortality. Similar results were observed for embolic and bleeding outcomes. Rivaroxaban treatment effects in patients not on an AAD were consistent with the overall trial (primary endpoint adjusted HR 0.82, 95% CI 0.68–0.98, pinteraction=0.06; safety endpoint adjusted HR 1.12, 95% CI 0.90–1.24, pinteraction=0.33). Conclusion Treatment with AADs was not associated with increased morbidity or mortality in anticoagulated patients with AF. The influence of amiodarone on outcomes in patients receiving rivaroxaban requires further study. PMID:24833235

  5. Implementing a guideline for the treatment of type 2 diabetics: results of a Cluster- Randomized Controlled Trial (C-RCT

    Directory of Open Access Journals (Sweden)

    Grasso Giuseppe

    2007-06-01

    Full Text Available Abstract Background In Italy many diabetics still lack adequate care in general practice. We assessed the effectiveness of different strategies for the implementation of an evidence-based guideline for the management of non-complicated type 2 diabetes among General Practitioners (GPs of Lazio region. Methods Three-arm cluster-randomised controlled trial with GPs as units of randomisation (clusters. 252 GPs were randomised either to an active strategy (training module with administration of the guideline, or to a passive dissemination (administration of the guideline only, or to usual care (control. Data on prescriptions of tests and drugs were collected by existing information systems, whereas patients' data came from GPs' databases. Process outcomes were measured at the cluster level one year after the intervention. Primary outcomes concerned the measurement of glycosilated haemoglobin and the commissioning of micro- and macrovascular complications assessment tests. In order to assess the physicians' drug prescribing behaviour secondary outcomes were also calculated. Results GPs identified 6395 uncomplicated type 2 patients with a high prevalence of cardiovascular risk factors. Data on GPs baseline performance show low proportions of glycosilated haemoglobin assessments. Results of the C-RCT analysis indicate that the active implementation strategy was ineffective relating to all primary outcomes (respectively, OR 1.06 [95% IC: 0.76–1.46]; OR 1.07 [95% IC: 0.80–1.43]; OR 1.4 [95% IC:0.91–2.16]. Similarly, passive dissemination of the guideline showed no effect. Conclusion In our region compliance of GPs with guidelines was not enhanced by a structured learning programme. Implementation through organizational measures appears to be essential to induce behavioural changes. Trial registration ISRCTN80116232

  6. Brief Report: Social Disability in Autism Spectrum Disorder--Results from Research Units on Pediatric Psychopharmacology (RUPP) Autism Network Trials

    Science.gov (United States)

    Scahill, Lawrence; Hallett, Victoria; Aman, Michael G.; McDougle, Christopher J.; Arnold, L. Eugene; McCracken, James T.; Tierney, Elaine; Deng, Yanhong; Dziura, James; Vitiello, Benedetto

    2013-01-01

    There is growing interest in measuring social disability as a core element of autism spectrum disorders in medication trials. We conducted a secondary analysis on the Aberrant Behavior Checklist Social Withdrawal subscale using data from two federally-funded, multi-site, randomized trials with risperidone. Study 1 included 52 subjects assigned to…

  7. Trial sequential analysis reveals insufficient information size and potentially false positive results in many meta-analyses

    DEFF Research Database (Denmark)

    Brok, Jesper; Thorlund, Kristian; Gluud, Christian;

    2008-01-01

    To evaluate meta-analyses with trial sequential analysis (TSA). TSA adjusts for random error risk and provides the required number of participants (information size) in a meta-analysis. Meta-analyses not reaching information size are analyzed with trial sequential monitoring boundaries analogous...

  8. Caloric restriction alters the metabolic response to a mixed-meal: results from a randomized, controlled trial.

    Directory of Open Access Journals (Sweden)

    Kim M Huffman

    Full Text Available OBJECTIVES: To determine if caloric restriction (CR would cause changes in plasma metabolic intermediates in response to a mixed meal, suggestive of changes in the capacity to adapt fuel oxidation to fuel availability or metabolic flexibility, and to determine how any such changes relate to insulin sensitivity (S(I. METHODS: Forty-six volunteers were randomized to a weight maintenance diet (Control, 25% CR, or 12.5% CR plus 12.5% energy deficit from structured aerobic exercise (CR+EX, or a liquid calorie diet (890 kcal/d until 15% reduction in body weightfor six months. Fasting and postprandial plasma samples were obtained at baseline, three, and six months. A targeted mass spectrometry-based platform was used to measure concentrations of individual free fatty acids (FFA, amino acids (AA, and acylcarnitines (AC. S(I was measured with an intravenous glucose tolerance test. RESULTS: Over three and six months, there were significantly larger differences in fasting-to-postprandial (FPP concentrations of medium and long chain AC (byproducts of FA oxidation in the CR relative to Control and a tendency for the same in CR+EX (CR-3 month P = 0.02; CR-6 month P = 0.002; CR+EX-3 month P = 0.09; CR+EX-6 month P = 0.08. After three months of CR, there was a trend towards a larger difference in FPP FFA concentrations (P = 0.07; CR-3 month P = 0.08. Time-varying differences in FPP concentrations of AC and AA were independently related to time-varying S(I (P<0.05 for both. CONCLUSIONS: Based on changes in intermediates of FA oxidation following a food challenge, CR imparted improvements in metabolic flexibility that correlated with improvements in S(I. TRIAL REGISTRATION: ClinicalTrials.gov NCT00099151.

  9. Phase 2 clinical trial of a recombinant adeno-associated viral vector expressing α1-antitrypsin: interim results.

    LENUS (Irish Health Repository)

    Flotte, Terence R

    2011-10-01

    Recombinant adeno-associated virus (rAAV) vectors offer promise for the gene therapy of α(1)-antitrypsin (AAT) deficiency. In our prior trial, an rAAV vector expressing human AAT (rAAV1-CB-hAAT) provided sustained, vector-derived AAT expression for >1 year. In the current phase 2 clinical trial, this same vector, produced by a herpes simplex virus complementation method, was administered to nine AAT-deficient individuals by intramuscular injection at doses of 6.0×10(11), 1.9×10(12), and 6.0×10(12) vector genomes\\/kg (n=3 subjects\\/dose). Vector-derived expression of normal (M-type) AAT in serum was dose dependent, peaked on day 30, and persisted for at least 90 days. Vector administration was well tolerated, with only mild injection site reactions and no serious adverse events. Serum creatine kinase was transiently elevated on day 30 in five of six subjects in the two higher dose groups and normalized by day 45. As expected, all subjects developed anti-AAV antibodies and interferon-γ enzyme-linked immunospot responses to AAV peptides, and no subjects developed antibodies to AAT. One subject in the mid-dose group developed T cell responses to a single AAT peptide unassociated with any clinical effects. Muscle biopsies obtained on day 90 showed strong immunostaining for AAT and moderate to marked inflammatory cell infiltrates composed primarily of CD3-reactive T lymphocytes that were primarily of the CD8(+) subtype. These results support the feasibility and safety of AAV gene therapy for AAT deficiency, and indicate that serum levels of vector-derived normal human AAT >20 μg\\/ml can be achieved. However, further improvements in the design or delivery of rAAV-AAT vectors will be required to achieve therapeutic target serum AAT concentrations.

  10. Carbon Dioxide Insufflation in Routine Colonoscopy Is Safe and More Comfortable: Results of a Randomized Controlled Double-Blinded Trial

    Directory of Open Access Journals (Sweden)

    M. Geyer

    2011-01-01

    Full Text Available Many patients experience pain and discomfort after colonoscopy. Carbon dioxide (CO2 can reduce periprocedural pain although air insufflation remained the standard procedure. The objective of this double-blinded, randomized controlled trial was to evaluate whether CO2 insufflation does decrease pain and bloating during and after colonoscopy compared to room air. Methods. 219 consecutive patients undergoing colonoscopy were randomized to either CO2 or air insufflation. Propofol was used in all patients for sedation. Transcutaneous CO2 was continuously measured with a capnograph as a safety parameter. Pain, bloating, and overall satisfaction were assessed at regular intervals before and after the procedure. Results(data are mean ±SD. 110 patients were randomized to CO2 and 109 to room air. The baseline characteristics were similar in both groups. The mean propofol dose was not different between the treatments, as were the time to reach the ileum and the withdrawal time. pCO2 at the end of the procedure was 35.2±4.3 mmHg (CO2 group versus 35.6±6.0 mmHg in the room air group (>.05. No relevant complication occurred in either group. There was significantly less bloating for the CO2 group during the postprocedural recovery period (<.001 and over the 24-hour period (<.001. Also, patients with CO2 insufflation experienced significantly less pain (=.014. Finally, a higher overall satisfaction (=.04 was found in the CO2 group. Conclusions. This trial provides compelling evidence that CO2 insufflation significantly reduces bloating and pain after routine colonoscopy in propofol-sedated patients. The procedure is safe with no significant differences in CO2 between the two groups.

  11. Carbon dioxide insufflation in routine colonoscopy is safe and more comfortable: results of a randomized controlled double-blinded trial.

    Science.gov (United States)

    Geyer, M; Guller, U; Beglinger, C

    2011-01-01

    Many patients experience pain and discomfort after colonoscopy. Carbon dioxide (CO(2)) can reduce periprocedural pain although air insufflation remained the standard procedure. The objective of this double-blinded, randomized controlled trial was to evaluate whether CO(2) insufflation does decrease pain and bloating during and after colonoscopy compared to room air. Methods. 219 consecutive patients undergoing colonoscopy were randomized to either CO(2) or air insufflation. Propofol was used in all patients for sedation. Transcutaneous CO(2) was continuously measured with a capnograph as a safety parameter. Pain, bloating, and overall satisfaction were assessed at regular intervals before and after the procedure. Results(data are mean ±SD). 110 patients were randomized to CO(2) and 109 to room air. The baseline characteristics were similar in both groups. The mean propofol dose was not different between the treatments, as were the time to reach the ileum and the withdrawal time. pCO(2) at the end of the procedure was 35.2 ± 4.3 mmHg (CO(2) group) versus 35.6 ± 6.0 mmHg in the room air group (P > .05). No relevant complication occurred in either group. There was significantly less bloating for the CO(2) group during the postprocedural recovery period (P < .001) and over the 24-hour period (P < .001). Also, patients with CO(2) insufflation experienced significantly less pain (P = .014). Finally, a higher overall satisfaction (P = .04 ) was found in the CO(2) group. Conclusions. This trial provides compelling evidence that CO(2) insufflation significantly reduces bloating and pain after routine colonoscopy in propofol-sedated patients. The procedure is safe with no significant differences in CO(2) between the two groups. PMID:21747649

  12. Is selective prenatal iron prophylaxis better than routine prophylaxis: final results of a trial (PROFEG) in Maputo, Mozambique

    Science.gov (United States)

    Hemminki, Elina; Nwaru, Bright I; Salomé, Graca; Parkkali, Saara; Abacassamo, Fatima; Augusto, Orvalho; Cliff, Julie; Regushevskaya, Elena; Dgedge, Martinho; Sousa, Cesar; Chilundo, Baltazar

    2016-01-01

    Objective To compare routine versus selective (ie, screening and treatment for anaemia) prenatal iron prophylaxis in a malaria-endemic and HIV-prevalent setting, an extended analysis including previously missing data. Design A pragmatic randomised controlled clinical trial. Setting 2 health centres in Maputo, Mozambique. Participants Pregnant women (≥18 years old; non-high-risk pregnancy) were randomly allocated to routine iron (n=2184) and selective iron (n=2142) groups. Interventions In the routine group, women received 60 mg ferrous sulfate plus 400 μg folic acid daily. In the selective group, women received 1 mg of folic acid daily and haemoglobin (Hb) screening at each visit; with low Hb (cut-off 9 g/dL) treatment (120 mg+800 μg of folic acid daily) for a month. Outcome measures Primary outcomes: preterm birth, low birth weight; secondary outcomes: self-reported malaria, labour complications, caesarean section, perinatal death, woman's death. Nurses collected pregnancy data. Birth data were abstracted from hospital records for 52% of women and traced using various methods and linked with probabilistic matching for 24%. Women's deaths were collected from death registers. Results Birth data were available for 3301 (76%) of the women. Outcomes were similar in the two groups: preterm births (27.1% in the selective vs 25.3% in the routine group), low birthweight infants (11.0% vs 11.7%), perinatal deaths (2.4% vs 2.4%) and caesarean sections (4.0% vs 4.5%). Women's deaths during pregnancy or iron groups. There might have been more women's deaths in the selective iron group, but it is unclear whether this was due to the intervention, other factors or chance finding. Trial registration number NCT00488579. PMID:27297013

  13. Safety Events in Kidney Transplant Recipients: Results from the Folic Acid for Vascular Outcome Reduction in Transplant (FAVORIT) Trial

    Science.gov (United States)

    Weir, Matthew R.; Gravens-Muller, Lisa; Costa, Nadiesda; Ivanova, Anastasia; Manitpisitkul, Wana; Bostom, Andrew G.; Diamantidis, Clarissa J.

    2015-01-01

    Background Kidney transplant recipients are at increased risk for adverse safety events related to their reduced renal function and many medications. Methods We determined the incidence of adverse safety events based on previously defined Agency for Healthcare and Research Quality (AHRQ) ICD-9 code-derived patient safety indicators (PSI) in the Folic Acid for Vascular Outcome Reduction in Transplant (FAVORIT) trial participants who had a hospitalization stratified by tertiles of estimated glomerular filtration rate. We also examined the frequency of Micromedex defined two precautionary drug-drug interactions, and two medications whose use may be contraindicated due to reduced GFR from the FAVORIT trial Medication Thesaurus at baseline, and annually among 4110 participants. Logistic regression was used to examine the relationship between patient safety events and baseline demographic and clinical variables at a participant level. Event rates were estimated at participant and visit levels. Results Of the 2514 patients with a hospitalization, 978 (38.9%) experienced an AHRQ PSI. Factors which were associated with more common AHRQ PSI included: US location, history of cardiovascular disease or diabetes, and lower tertile of estimated GFR. At a participant level, 2524 of the 4110 participants (61.4%) were taking a CNI and a statin, 378 (9.2%) were taking azathioprine and an ACE inhibitor, 171 (12.9%) were taking a sulfonylurea ), 45 (3.4%) were taking metformin despite a baseline GFR below 40 ml/min/1.73m2. Conclusions We conclude that patient safety events are not uncommon in kidney transplant recipients. Careful monitoring is necessary to prevent adverse outcomes. PMID:25393158

  14. Housing first reduces re-offending among formerly homeless adults with mental disorders: results of a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Julian M Somers

    Full Text Available BACKGROUND: Homelessness and mental illness have a strong association with public disorder and criminality. Experimental evidence indicates that Housing First (HF increases housing stability and perceived choice among those experiencing chronic homelessness and mental disorders. HF is also associated with lower residential costs than common alternative approaches. Few studies have examined the effect of HF on criminal behavior. METHODS: Individuals meeting criteria for homelessness and a current mental disorder were randomized to one of three conditions treatment as usual (reference; scattered site HF; and congregate HF. Administrative data concerning justice system events were linked in order to study prior histories of offending and to test the relationship between housing status and offending following randomization for up to two years. RESULTS: The majority of the sample (67% was involved with the justice system, with a mean of 8.07 convictions per person in the ten years prior to recruitment. The most common category of crime was "property offences" (mean=4.09. Following randomization, the scattered site HF condition was associated with significantly lower numbers of sentences than treatment as usual (Adjusted IRR=0.29; 95% CI 0.12-0.72. Congregate HF was associated with a marginally significant reduction in sentences compared to treatment as usual (Adjusted IRR=0.55; 95% CI: 0.26-1.14. CONCLUSIONS: This study is the first randomized controlled trial to demonstrate benefits of HF among a homeless sample with mental illness in the domain of public safety and crime. Our sample was frequently involved with the justice system, with great personal and societal costs. Further implementation of HF is strongly indicated, particularly in the scattered site format. Research examining interdependencies between housing, health, and the justice system is indicated. TRIAL REGISTRATION: ISRCTN57595077.

  15. Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres

    DEFF Research Database (Denmark)

    Kuchinke, Wolfgang; Ohmann, Christian; Yang, Qin;

    2010-01-01

    The use of Clinical Data Management Systems (CDMS) has become essential in clinical trials to handle the increasing amount of data that must be collected and analyzed. With a CDMS trial data are captured at investigator sites with "electronic Case Report Forms". Although more and more of these el...... of these electronic data management systems are used in academic research centres an overview of CDMS products and of available data management and quality management resources for academic clinical trials in Europe is missing.......The use of Clinical Data Management Systems (CDMS) has become essential in clinical trials to handle the increasing amount of data that must be collected and analyzed. With a CDMS trial data are captured at investigator sites with "electronic Case Report Forms". Although more and more...

  16. Long-term results of a randomized phase III trial of TPF induction chemotherapy followed by surgery and radiation in locally advanced oral squamous cell carcinoma

    OpenAIRE

    Zhong, Lai-ping; Zhang, Chen-Ping; Ren, Guo-xin; Guo, Wei; William, William N.; Hong, Christopher S.; Sun, Jian; ZHU, HAN-GUANG; Tu, Wen-yong; Li, Jiang; Cai, Yi-li; Yin, Qiu-ming; WANG, LI-ZHEN; Wang, Zhong-he; Hu, Yong-jie

    2015-01-01

    Previously, we conducted a randomized phase III trial of TPF (docetaxel, cisplatin, and 5-fluorouracil) induction chemotherapy in surgically managed locally advanced oral squamous cell carcinoma (OSCC) and found no improvement in overall survival. This study reports long-term follow-up results from our initial trial. All patients had clinical stage III or IVA locally advanced OSCC. In the experimental group, patients received two cycles of TPF induction chemotherapy (75mg/m2 docetaxel d1, 75m...

  17. Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and Patient Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT)

    OpenAIRE

    Haloua, Max H; Volders, José H.; Krekel, Nicole M. A.; Lopes Cardozo, Alexander M. F.; de Roos, Wifred K.; de Widt-Levert, Louise M.; van der Veen, Henk; Rijna, Herman; Bergers, Elisabeth; Jóźwiak, Katarzyna; Meijer, Sybren; van den Tol, M. Petrousjka

    2015-01-01

    Background Ultrasound-guided breast-conserving surgery (USS) results in a significant reduction in both margin involvement and excision volumes (COBALT trial). Objective The aim of the present study was to determine whether USS also leads to improvements in cosmetic outcome and patient satisfaction when compared with standard palpation-guided surgery (PGS). Methods A total of 134 patients with T1–T2 invasive breast cancer were included in the COBALT trial (NTR2579) and randomized to either US...

  18. Partial breast irradiation for early breast cancer: 3-year results of the German-Austrian phase II-trial

    International Nuclear Information System (INIS)

    Purpose: to evaluate perioperative morbidity, toxicity and cosmetic outcome in patients treated with interstitial brachytherapy to the tumor bed as the sole radiation modality after breast conserving surgery. Materials and methods: from 11/2000 to 11/2004, 240 women with early stage breast cancer participated in a protocol of tumor bed irradiation alone using pulsed dose rate (PDR) or high dose rate (HDR) interstitial multi-catheter implants (partial breast irradiation). Perioperative morbidity, acute and late toxicity as well as cosmetic outcome were assessed. Of the first 51 patients treated in this multicenter trial, we present interim findings after a median follow-up of 36 months. Results: perioperative Morbidity: Bacterial infection of the implant: 2% (1/51). Acute toxicity: radiodermatitis grade 1: 4% (2/51). Late toxicity: breast pain grade 1: 8% (4/51), grade 2: 2% (1/51); dyspigmentation grade 1: 8% (4/51); fibrosis grade 1: 4% (2/51), grade 2: 8% (4/51); telangiectasia grade 1: 10% (5/51), grade 2: 4% (2/51). Cosmetic results: Excellent and good in 94% (48/51) of the patients. Conclusion: this analysis indicates that accelerated partial breast irradiation with 192-iridium interstitial multicatheter PDR-/HDR-implants (partial breast irradiation) is feasible with low perioperative morbidity, low acute and mild late toxicity at a median follow-up of 36 months. The cosmetic result is not significantly affected. (orig.)

  19. Resource Utilisation and Costs of Depressive Patients in Germany: Results from the Primary Care Monitoring for Depressive Patients Trial

    Directory of Open Access Journals (Sweden)

    Christian Krauth

    2014-01-01

    Full Text Available Background. Depression is the most common type of mental disorder in Germany. It is associated with a high level of suffering for individuals and imposes a significant burden on society. The aim of this study was to estimate the depression related costs in Germany taking a societal perspective. Materials and Methods. Data were collected from the primary care monitoring for depressive patients trial (PRoMPT of patients with major depressive disorder who were treated in a primary care setting. Resource utilisation and days of sick leave were observed and analysed over a 1-year period. Results. Average depression related costs of €3813 were calculated. Significant differences in total costs due to sex were demonstrated. Male patients had considerable higher total costs than female patients, whereas single cost categories did not differ significantly. Further, differences in costs according to severity of disease and age were observed. The economic burden to society was estimated at €15.6 billion per year. Conclusion. The study results show that depression poses a significant economic burden to society. There is a high potential for prevention, treatment, and patient management innovations to identify and treat patients at an early stage.

  20. Effects of lifestyle intervention in persons at risk for type 2 diabetes mellitus - results from a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Nilsen Vegard

    2011-11-01

    the proportion of participants with unhealthy diet (almost 50% absolute reduction. Conclusion It is possible to achieve important lifestyle changes in persons at risk for type 2 diabetes with modest clinical efforts. Group intervention yields no additional effects. The design of the study, with high inclusion and low dropout rates, should make the results applicable to ordinary clinical settings. Trial registration ClinicalTrials.gov: NCT00202748

  1. Multileaf Collimator Tracking Improves Dose Delivery for Prostate Cancer Radiation Therapy: Results of the First Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Colvill, Emma [Radiation Physics Laboratory, University of Sydney, Sydney, NSW (Australia); Northern Sydney Cancer Centre, Royal North Shore Hospital, St. Leonards, NSW (Australia); Booth, Jeremy T. [Northern Sydney Cancer Centre, Royal North Shore Hospital, St. Leonards, NSW (Australia); School of Physics, University of Sydney, Sydney, NSW (Australia); O' Brien, Ricky T. [Radiation Physics Laboratory, University of Sydney, Sydney, NSW (Australia); Eade, Thomas N.; Kneebone, Andrew B. [Northern Sydney Cancer Centre, Royal North Shore Hospital, St. Leonards, NSW (Australia); Poulsen, Per R. [Aarhus University Hospital, Aarhus (Denmark); Keall, Paul J., E-mail: paul.keall@sydney.edu.au [Radiation Physics Laboratory, University of Sydney, Sydney, NSW (Australia)

    2015-08-01

    Purpose: To test the hypothesis that multileaf collimator (MLC) tracking improves the consistency between the planned and delivered dose compared with the dose without MLC tracking, in the setting of a prostate cancer volumetric modulated arc therapy trial. Methods and Materials: Multileaf collimator tracking was implemented for 15 patients in a prostate cancer radiation therapy trial; in total, 513 treatment fractions were delivered. During each treatment fraction, the prostate trajectory and treatment MLC positions were collected. These data were used as input for dose reconstruction (multiple isocenter shift method) to calculate the treated dose (with MLC tracking) and the dose that would have been delivered had MLC tracking not been applied (without MLC tracking). The percentage difference from planned for target and normal tissue dose-volume points were calculated. The hypothesis was tested for each dose-volume value via analysis of variance using the F test. Results: Of the 513 fractions delivered, 475 (93%) were suitable for analysis. The mean difference and standard deviation between the planned and treated MLC tracking doses and the planned and without-MLC tracking doses for all 475 fractions were, respectively, PTV D{sub 99%} −0.8% ± 1.1% versus −2.1% ± 2.7%; CTV D{sub 99%} −0.6% ± 0.8% versus −0.6% ± 1.1%; rectum V{sub 65%} 1.6% ± 7.9% versus −1.2% ± 18%; and bladder V{sub 65%} 0.5% ± 4.4% versus −0.0% ± 9.2% (P<.001 for all dose-volume results). Conclusion: This study shows that MLC tracking improves the consistency between the planned and delivered doses compared with the modeled doses without MLC tracking. The implications of this finding are potentially improved patient outcomes, as well as more reliable dose-volume data for radiobiological parameter determination.

  2. Treating adolescents with cannabis use disorder with Multidimensional Family Therapy (MDFT): Main results of a Randomized Controlled Trial (RCT)

    NARCIS (Netherlands)

    P. Tossmann (Peter); B. Jonas (Benjamin); H. Rigter (Henk); A. Gantner (Andreas)

    2012-01-01

    textabstractAims: To determine the effectiveness of Multidimensional Family Therapy (MDFT) among adolescents with cannabis use disorder in Germany. Methods: In a randomized controlled trial (RCT), MDFT was compared with Youth Psychotherapy (JUP), an individual intervention including Cognitive Behavi

  3. Results of a multicenter randomized controlled trial of the clinical effectiveness of schema therapy for personality disorders

    NARCIS (Netherlands)

    L.L.M. Bamelis; S.M.A.A. Evers; P. Spinhoven; A. Arntz

    2014-01-01

    Objective: The authors compared the effectiveness of 50 sessions of schema therapy with clarification-oriented psychotherapy and with treatment as usual among patients with cluster C, paranoid, histrionic, or narcissistic personality disorder. Method: A multicenter randomized controlled trial, with

  4. Electrons for intraoperative radiotherapy in selected breast-cancer patients: late results of the Montpellier phase II trial

    International Nuclear Information System (INIS)

    The Montpellier cancer institute phase II trial started in 2004 and evaluated the feasibility of intraoperative radiotherapy (IORT) technique given as a sole radiation treatment for patients with an excellent prognostic and very low recurrence risk. Forty-two patients were included between 2004 and 2007. Inclusion criteria were patients ≥ 65 years old, T0-T1, N0, ductal invasive unifocal carcinoma, free-margin > 2 mm. IORT was delivered using dedicated linear accelerator. One fraction of 21 Gy was prescribed and specified at the 90% isodose using electrons. In vivo dosimetry was performed for all patients. Primary end-point was the quality index. Secondary endpoints were quality of life, local recurrences, cosmetic results, specific and overall survival. At inclusion, median age was 72 years (range, 66–80). Median tumor diameter was 10 mm. All patients received the total prescribed dose. No acute grade 3 toxicities were observed. Late cosmetic results were good at 5 years despite the poor agreement of accuracy assessment between patients and physicians. Four patients (9.5%) experienced a local failure and underwent salvage mastectomy. The 5 year-disease free survival is 92.7% (range 79.1−97.6). All patients are still alive with a median follow-up of 72 months (range 66–74). Our results confirm with a long-term follow-up that exclusive partial breast IORT is feasible for early-breast cancer in selected patients. IORT provides good late cosmetics results and should be considered as a safe and very comfortable “one-step” treatment procedure. Nevertheless, patient assessments are essential for long-term quality results

  5. Irrefutable evidence for the use of docetaxel in newly diagnosed metastatic prostate cancer: results from the STAMPEDE and CHAARTED trials

    OpenAIRE

    Soest, Robert Jan; de Wit, Ronald

    2015-01-01

    textabstractAndrogen deprivation therapy (ADT) has been used in the treatment of metastatic prostate cancer since the first description of its hormonal dependence in 1941. In 2004, docetaxel chemotherapy became the mainstay of treatment in metastatic castration-resistant prostate cancer (mCRPC), following robust, albeit modest, survival benefit in two randomized phase 3 trials. The recently published CHAARTED trial was the first to show that combining ADT with docetaxel in men with hormone-na...

  6. Why Are Clinicians Not Embracing the Results from Pivotal Clinical Trials in Severe Sepsis? A Bayesian Analysis

    OpenAIRE

    Kalil, Andre C.; Sun, Junfeng

    2008-01-01

    Background Five pivotal clinical trials (Intensive Insulin Therapy; Recombinant Human Activated Protein C [rhAPC]; Low-Tidal Volume; Low-Dose Steroid; Early Goal-Directed Therapy [EGDT]) demonstrated mortality reduction in patients with severe sepsis and expert guidelines have recommended them to clinical practice. Yet, the adoption of these therapies remains low among clinicians. Objectives We selected these five trials and asked: Question 1-What is the current probability that the new thera...

  7. A review of blood substitutes: examining the history, clinical trial results, and ethics of hemoglobin-based oxygen carriers

    OpenAIRE

    Jiin-Yu Chen; Michelle Scerbo; George Kramer

    2009-01-01

    The complications associated with acquiring and storing whole blood for transfusions have launched substantial efforts to develop a blood substitute. The history of these efforts involves a complicated mixture of science, ethics, and business. This review focuses on clinical trials of the three hemoglobin-based oxygen carriers (HBOC) that have progressed to Phase II or III clinical trials: He-mAssist (Baxter; Deerfield, IL, US), PolyHeme (Northfield; Evanston, IL, US), and Hemopure (Biopure; ...

  8. Positive Outcomes Influence the Rate and Time to Publication, but Not the Impact Factor of Publications of Clinical Trial Results

    OpenAIRE

    Suñé, Pilar; Suñé, Josep Maria; Montoro, J. Bruno

    2013-01-01

    Objectives: Publication bias may affect the validity of evidence based medical decisions. The aim of this study is to assess whether research outcomes affect the dissemination of clinical trial findings, in terms of rate, time to publication, and impact factor of journal publications. Methods and Findings: All drug-evaluating clinical trials submitted to and approved by a general hospital ethics committee between 1997 and 2004 were prospectively followed to analyze their fate and publication....

  9. Benign painful shoulder syndrome. Initial results of a single-center prospective randomized radiotherapy dose-optimization trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Hertel, S.; Gaipl, U.S.; Frey, B.; Schmidt, M.; Fietkau, R. [University Hospital Erlangen (Germany). Department of Radiation Oncology

    2012-12-15

    Background and purpose: To compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with benign painful shoulder syndrome. Patients and methods: Between February 2006 and February 2010, 312 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions in 3 weeks. In case of insufficient remission of pain after 6 weeks, a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 83% directly after and 85% 6 weeks after radiotherapy. The mean VAS values before, directly after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 56.8 {+-} 23.7 and 53.2 {+-} 21.8 (p = 0.158), 38.2 {+-} 26.1 and 34.0 {+-} 24.5 (p = 0.189), and 33.0 {+-} 27.2 and 23.7 {+-} 22.7 (p = 0.044), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 9.7 {+-} 3.0 and 9.5 {+-} 2.7 (p = 0.309), 6.1 {+-} 3.6 and 5.4 {+-} 3.6 (p = 0.096), 5.3 {+-} 3.7 and 4.1 {+-} 3.7 (p = 0.052), respectively. Despite a slight advantage in the VAS analysis for the 1.0 Gy group for delayed response, the CPS analysis revealed no statistically significant differences between the two single-dose trial arms for early (p = 0.652) and delayed response quality (p = 0.380). Conclusion: Radiotherapy is an effective treatment option for the management of benign painful shoulder syndrome. Concerning radiation protection, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  10. Psychosocial impact of alternative management policies for low-grade cervical abnormalities: results from the TOMBOLA randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Linda Sharp

    Full Text Available BACKGROUND: Large numbers of women who participate in cervical screening require follow-up for minor cytological abnormalities. Little is known about the psychological consequences of alternative management policies for these women. We compared, over 30-months, psychosocial outcomes of two policies: cytological surveillance (repeat cervical cytology tests in primary care and a hospital-based colposcopy examination. METHODS: Women attending for a routine cytology test within the UK NHS Cervical Screening Programmes were eligible to participate. 3399 women, aged 20-59 years, with low-grade abnormal cytology, were randomised to cytological surveillance (six-monthly tests; n = 1703 or initial colposcopy with biopsies and/or subsequent treatment based on colposcopic and histological findings (n = 1696. At 12, 18, 24 and 30-months post-recruitment, women completed the Hospital Anxiety and Depression Scale (HADS. A subgroup (n = 2354 completed the Impact of Event Scale (IES six weeks after the colposcopy episode or first surveillance cytology test. Primary outcomes were percentages over the entire follow-up period of significant depression (≥ 8 and significant anxiety (≥ 11; "30-month percentages". Secondary outcomes were point prevalences of significant depression, significant anxiety and procedure-related distress (≥ 9. Outcomes were compared between arms by calculating fully-adjusted odds ratios (ORs for initial colposcopy versus cytological surveillance. RESULTS: There was no significant difference in 30-month percentages of significant depression (OR = 0.99, 95% CI 0.80-1.21 or anxiety (OR = 0.97, 95% CI 0.81-1.16 between arms. At the six-week assessment, anxiety and distress, but not depression, were significantly less common in the initial colposcopy arm (anxiety: 7.9% vs 13.4%; OR = 0.55, 95% CI 0.38-0.81; distress: 30.6% vs 39.3%, OR = 0.67 95% CI 0.54-0.84. Neither anxiety nor depression differed between arms at subsequent time

  11. Benign painful shoulder syndrome. Initial results of a single-center prospective randomized radiotherapy dose-optimization trial

    International Nuclear Information System (INIS)

    Background and purpose: To compare the efficacy of two different dose-fractionation schedules for radiotherapy of patients with benign painful shoulder syndrome. Patients and methods: Between February 2006 and February 2010, 312 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received radiotherapy with an orthovoltage technique. One radiotherapy course consisted of 6 single fractions in 3 weeks. In case of insufficient remission of pain after 6 weeks, a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. The endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after radiotherapy using a visual analogue scale (VAS) and a comprehensive pain score (CPS). Results: The overall response rate for all patients was 83% directly after and 85% 6 weeks after radiotherapy. The mean VAS values before, directly after, and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 56.8 ± 23.7 and 53.2 ± 21.8 (p = 0.158), 38.2 ± 26.1 and 34.0 ± 24.5 (p = 0.189), and 33.0 ± 27.2 and 23.7 ± 22.7 (p = 0.044), respectively. The mean CPS before, directly after, and 6 weeks after treatment was 9.7 ± 3.0 and 9.5 ± 2.7 (p = 0.309), 6.1 ± 3.6 and 5.4 ± 3.6 (p = 0.096), 5.3 ± 3.7 and 4.1 ± 3.7 (p = 0.052), respectively. Despite a slight advantage in the VAS analysis for the 1.0 Gy group for delayed response, the CPS analysis revealed no statistically significant differences between the two single-dose trial arms for early (p = 0.652) and delayed response quality (p = 0.380). Conclusion: Radiotherapy is an effective treatment option for the management of benign painful shoulder syndrome. Concerning radiation protection, the dose for a radiotherapy series is recommended not to exceed 3-6 Gy. (orig.)

  12. Results of a Feasibility and Acceptability Trial of an Online Smoking Cessation Program Targeting Young Adult Nondaily Smokers

    Directory of Open Access Journals (Sweden)

    Carla J. Berg

    2012-01-01

    Full Text Available Despite increases in nondaily smoking among young adults, no prior research has aimed to develop and test an intervention targeting this group. Thus, we aimed to develop and test the feasibility, acceptability, and potential effectiveness of an online intervention targeting college student nondaily smokers. We conducted a one-arm feasibility and acceptability trial of a four-week online intervention with weekly contacts among 31 college student nondaily smokers. We conducted assessments at baseline (B, end of treatment (EOT, and six-week followup (FU. We maintained a 100% retention rate over the 10-week period. Google Analytics data indicated positive utilization results, and 71.0% were satisfied with the program. There were increases (P<.001 in the number of people refraining from smoking for the past 30 days and reducing their smoking from B to EOT and to FU, with additional individuals reporting being quit despite recent smoking. Participants also increased in their perceptions of how bothersome secondhand smoke is to others (P<.05; however, no other attitudinal variables were altered. Thus, this intervention demonstrated feasibility, acceptability, and potential effectiveness among college-aged nondaily smokers. Additional research is needed to understand how nondaily smokers define cessation, improve measures for cessation, and examine theoretical constructs related to smoking among this population.

  13. Amisulpride a selective dopamine antagonist and atypical antipsychotic: results of a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Leucht, Stefan

    2004-03-01

    The pharmacological profiles of the atypical antipsychotics, clozapine, olanzapine, quetiapine and risperidone, all show a combined serotonin (5-HT2) and dopamine type-2 (D2) receptor antagonism. Amisulpride, a highly selective dopamine D2/D3 receptor antagonist that binds preferentially to receptors in the mesolimbic system, is also an 'atypical' antipsychotic despite having a different receptor-affinity profile. A meta-analysis of 18 clinical trials was undertaken to compare the efficacy and safety of amisulpride with conventional antipsychotics. The improvement in mental state was assessed using the Brief Psychiatric Rating Scale (BPRS) or the Scale for the Assessment of Negative Symptoms (SANS). In a pooled analysis of 10 studies of acutely ill patients, amisulpride was significantly more effective than conventional neuroleptics with regard to improvement of global symptoms. Amisulpride is, to date, the only atypical antipsychotic for which several studies on patients suffering predominantly from negative symptoms have been published. In four such studies, amisulpride was significantly superior to placebo. Three small studies with conventional neuroleptics as a comparator showed only a trend in favour of amisulpride in this regard. Amisulpride was associated with fewer extrapyramidal side-effects and fewer drop-outs due to adverse events than conventional neuroleptics. These results clearly show that amisulpride is an 'atypical' antipsychotic, and they cast some doubt on the notion that combined 5-HT2-D2 antagonism is the only reason for the high efficacy against negative symptoms and fewer extrapyramidal side-effects.

  14. Health care costs associated with gestational diabetes mellitus among high-risk women – results from a randomised trial

    Directory of Open Access Journals (Sweden)

    Kolu Päivi

    2012-07-01

    Full Text Available Abstract Background The costs of gestational diabetes mellitus (GDM screening have been frequently reported, but total GDM-related health care costs compared to the health care costs of women without GDM have not been reported. The aim of this study was to analyse GDM-related health care costs among women with an elevated risk of GDM. Methods The study was based on a cluster-randomised GDM prevention trial (N = 848 carried out at maternity clinics, combined with data from the Finnish Medical Birth Register and Care Registers for Social Welfare and Health Care. Costs of outpatient visits to primary and secondary care, cost of inpatient hospital care before and after delivery, the use of insulin, delivery costs and babies’ stay in the neonatal intensive care unit were analysed. Women who developed GDM were compared to those who were not diagnosed with GDM. Results Total mean health care costs adjusted for age, body mass index and education were 25.1% higher among women diagnosed with GDM (€6,432 vs. €5,143, p  Conclusions A confirmed GDM diagnosis was associated with a significant increase in total health care costs. Effective lifestyle counselling by primary health care providers may offer a means of reducing the high costs of secondary care.

  15. A low-cost repellent for malaria vectors in the Americas: results of two field trials in Guatemala and Peru

    Directory of Open Access Journals (Sweden)

    Sihuincha Moisés

    2007-08-01

    Full Text Available Abstract Background The cost of mosquito repellents in Latin America has discouraged their wider use among the poor. To address this problem, a low-cost repellent was developed that reduces the level of expensive repellent actives by combining them with inexpensive fixatives that appear to slow repellent evaporation. The chosen actives were a mixture of para-menthane-diol (PMD and lemongrass oil (LG. Methods To test the efficacy of the repellent, field trials were staged in Guatemala and Peru. Repellent efficacy was determined by human-landing catches on volunteers who wore the experimental repellents, control, or 15% DEET. The studies were conducted using a balanced Latin Square design with volunteers, treatments, and locations rotated each night. Results In Guatemala, collections were performed for two hours, commencing three hours after repellent application. The repellent provided >98% protection for five hours after application, with a biting pressure of >100 landings per person/hour. The 15% DEET control provided lower protection at 92% (p 46 landings per person/hour. The 20% DEET control provided significantly lower protection at 64% (p Conclusion In both locations, the PMD/LG repellent provided excellent protection up to six hours after application against a wide range of disease vectors including Anopheles darlingi. The addition of fixatives to the repellent extended its longevity while enhancing efficacy and significantly reducing its cost to malaria-endemic communities.

  16. Compensatory cognitive training for people with first-episode schizophrenia: results from a pilot randomized controlled trial.

    Science.gov (United States)

    Mendella, Paul D; Burton, Cynthia Z; Tasca, Giorgio A; Roy, Paul; St Louis, Lea; Twamley, Elizabeth W

    2015-03-01

    Cognitive training or remediation now has multiple studies and meta-analyses supporting its efficacy in improving cognition and functioning in people with schizophrenia. However, relatively little is known about cognitive training outcomes in early psychosis. We conducted a pilot randomized controlled trial of Compensatory Cognitive Training (CCT) compared to Treatment as Usual (TAU) in 27 participants with first-episode psychosis who had received treatment for psychosis for less than six months. Assessments of cognition (MATRICS Consensus Cognitive Battery; MCCB) and functional capacity (UCSD Performance-Based Skills Assessment-Brief; UPSA-B) were administered at baseline and following the 12-week treatment. The CCT condition, compared to TAU, was associated with significant improvements on the MCCB composite score, as well as MCCB subtests measuring processing speed (Trail Making) and social cognition (Mayer-Salovey-Caruso Emotional Intelligence Test), with large effects on these three outcome measures. There were no significant CCT-associated effects on the UPSA-B or on positive, negative, or depressive symptoms. CCT treatment of cognitive impairments in first-episode schizophrenia is feasible and can result in large effect size improvements in global cognition, processing speed, and social cognition. PMID:25631454

  17. Effect of recombinant alpha interferon on NK and ADCC function in lung cancer patients: results from a phase II trial

    DEFF Research Database (Denmark)

    Hokland, P; Hokland, M; Olesen, B K;

    1985-01-01

    that this decrease might be attributable to either an exhaustion phenomenon or to an induction of a refractory state of peripheral blood NK cells. When measuring ADCC activity, increases in lytic activity were seen only in patients in whom they could be attributed to non-IgG-dependent (NK-like) mechanisms......During a phase II trial of recombinant IFN-alpha given in doses of 50 X 10(6) units/m2 three times per week to lung cancer patients, 13 patients were evaluated longitudinally in NK and ADCC assays and in immunofluorescence tests enumerating the number of cells reactive with the new N901 NK......-cell antibody. An increase in NK-cell activity could be demonstrated when values before and 24 h after the first injection of IFN were compared, but simultaneously the enhancing effect of IFN-alpha on NK-cells added to in vitro cultures was abolished, probably as a result of preactivation of NK cells in vivo...

  18. Target volume for postoperative radiotherapy in non-small cell lung cancer: Results from a prospective trial

    International Nuclear Information System (INIS)

    Background and purpose: A previous prospective trial reported that three-dimensional conformal postoperative radiotherapy (PORT) for pN2 NSCLC patients using a limited clinical target volume (CTV) had a late morbidity rate and pulmonary function that did not differ from those observed in pN1 patients treated with surgery without PORT. The aim of this study was to assess locoregional control and localization of failure in patients treated with PORT. Materials and methods: The pattern of locoregional failure was evaluated retrospectively in 151 of 171 patients included in the PORT arm. The CTV included the involved lymph node stations and those with a risk of invasion >10%. Competing risk analysis was used to assess the incidence of locoregional failure and its location outside the CTV. Results: Overall survival at 5 years was 27.1% with a median follow-up of 67 months for 40 living patients. The 5-year cumulative incidence of locoregional failure was 19.4% (95% CI: 18.2–20.5%) including a failure rate of 2% (95% CI: 0–17%) in locations outside or at the border of the CTV. Conclusions: The use of limited CTV was associated with acceptable risk of geographic miss. Overall locoregional control was similar to that reported by other studies using PORT for pN2 patients

  19. Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials

    Science.gov (United States)

    McElroy, Susan L; Hudson, James; Ferreira-Cornwell, M Celeste; Radewonuk, Jana; Whitaker, Timothy; Gasior, Maria

    2016-01-01

    The efficacy and safety of lisdexamfetamine dimesylate (LDX) vs placebo in binge eating disorder (BED) was evaluated in two multicenter, double-blind, placebo-controlled trials. Adults (study 1, n=383; study 2, n=390) meeting DSM-IV-TR BED criteria were randomized (1:1) to placebo or LDX (50 or 70 mg/day) dose titration; optimized doses were maintained to the end of double-blind treatment (week 12/early termination). Change from baseline in binge eating days/week at weeks 11−12 (primary efficacy endpoint) was assessed with mixed-effects models for repeated measures. Secondary endpoints related to binge eating and medical parameters, safety, and treatment compliance were also assessed. Least squares mean (95% CI) treatment differences for change from baseline binge eating days/week at weeks 11–12 significantly favored LDX (study 1: –1.35 [–1.70, –1.01] study 2: –1.66 [–2.04, –1.28] both Peating days/week from baseline and improving binge eating–related key secondary endpoints. Safety results appear consistent with the known safety profile of LDX. PMID:26346638

  20. Effects of a price increase on purchases of sugar sweetened beverages. Results from a randomized controlled trial.

    Science.gov (United States)

    Waterlander, Wilma Elzeline; Ni Mhurchu, Cliona; Steenhuis, Ingrid H M

    2014-07-01

    Sugar sweetened beverage (SSB) taxes are receiving increased political interest. However, there have been no experimental studies of the effects of price increases on SSBs or the effects on close substitutes such as diet drinks, alcohol or sugary snacks. Therefore, the aim of this study was to examine the effects of a price increase on SSBs on beverage and snack purchases using a randomized controlled design within a three-dimensional web-based supermarket. The trial contained two conditions: experimental condition with a 19% tax on SSBs (to reflect an increase in Dutch value added tax from 6% to 19%); and a control condition with regular prices. N = 102 participants were randomized and purchased groceries on a single occasion at a three-dimensional Virtual Supermarket. Data were analysed using independent t-tests and regression analysis. Results showed that participants in the price increase condition purchased significantly less SSBs than the control group (B = -.90; 95% CI = -1.70 to -.10 L per household per week). There were no significant effects on purchases in other beverage or snack food categories. This means that the higher VAT rate was effective in reducing SSB purchases and had no negative side-effects. PMID:24667153

  1. Effects of a price increase on purchases of sugar sweetened beverages. Results from a randomized controlled trial.

    Science.gov (United States)

    Waterlander, Wilma Elzeline; Ni Mhurchu, Cliona; Steenhuis, Ingrid H M

    2014-07-01

    Sugar sweetened beverage (SSB) taxes are receiving increased political interest. However, there have been no experimental studies of the effects of price increases on SSBs or the effects on close substitutes such as diet drinks, alcohol or sugary snacks. Therefore, the aim of this study was to examine the effects of a price increase on SSBs on beverage and snack purchases using a randomized controlled design within a three-dimensional web-based supermarket. The trial contained two conditions: experimental condition with a 19% tax on SSBs (to reflect an increase in Dutch value added tax from 6% to 19%); and a control condition with regular prices. N = 102 participants were randomized and purchased groceries on a single occasion at a three-dimensional Virtual Supermarket. Data were analysed using independent t-tests and regression analysis. Results showed that participants in the price increase condition purchased significantly less SSBs than the control group (B = -.90; 95% CI = -1.70 to -.10 L per household per week). There were no significant effects on purchases in other beverage or snack food categories. This means that the higher VAT rate was effective in reducing SSB purchases and had no negative side-effects.

  2. Antimicrobial Susceptibility of Bloodstream Isolates of Staphylococcus aureus: Global Results from the Tigecycline Evaluation and Surveillance Trial, 2004-2008

    Directory of Open Access Journals (Sweden)

    Daniel Amsterdam

    2010-01-01

    Full Text Available Problem statement: The Tigecycline Evaluation and Surveillance Trial (TEST commenced in 2004 to monitor the activity of tigecycline, a new glycylcycline and numerous comparators against major hospital-and community-associated pathogens. In this report we examine the efficacy of tigecycline and comparators against isolates of Staphylococcus aureus collected from blood. Approach: Almost 4000 blood-derived isolates of Staphylococcus aureus were collected from participating centers globally between 2004-2008. Results: All isolates were susceptible to tigecycline (MIC90 0.25 mg L-1 and linezolid (MIC90 4 mg L-1; 99.9% of isolates were susceptible to vancomycin (MIC90 1 mg L-1. Tigecycline and linezolid activity were unaffected by resistance to methicillin, ICU vs non-ICU isolate collection or the age of patients from which the isolates were collected. Although 95.3% of MSSA were levofloxacin susceptible, only 14.4% of MRSA isolates were susceptible to levofloxacin in this study. Conclusion: Tigecycline is shown here to be active against S. aureus isolates collected from blood and is unaffected by methicillin resistance. However, tigecycline is not as yet approved for the treatment of bacteremic infections.

  3. Randomized Controlled Trial of Forward-Planned Intensity Modulated Radiotherapy for Early Breast Cancer: Interim Results at 2 Years

    International Nuclear Information System (INIS)

    Purpose: This single-center randomized trial was designed to investigate whether intensity-modulated radiotherapy (IMRT) reduces late toxicity in patients with early-stage breast cancer. Methods and Materials: The standard tangential plans of 1,145 nonselected patients were analyzed. The patients with inhomogeneous plans were randomized to a simple method of forward-planned IMRT or standard radiotherapy (RT). The primary endpoint was serial photographic assessment of breast shrinkage. Results: At 2 years, no significant difference was found in the development of any photographically assessed breast shrinkage between the patients randomized to the interventional or control group (odds ratio, 1.51; 95% confidence interval, 0.83–1.58; p = .41). The patients in the control group were more likely to develop telangiectasia than those in the IMRT group (odds ratio, 1.68; 95% confidence interval 1.13–2.40; p = .009). Poor baseline surgical cosmesis resulted in poor overall cosmesis at 2 years after RT. In patients who had good surgical cosmesis, those randomized to IMRT were less likely to deteriorate to a moderate or poor overall cosmesis than those in the control group (odds ratio, 0.63; 95% confidence interval, 0.39–1.03, p = .061). Conclusions: IMRT can lead to a significant reduction in telangiectasia at comparatively early follow-up of only 2 years after RT completion. An important component of breast induration and shrinkage will actually result from the surgery and not from the RT. Surgical cosmesis is an important determinant of overall cosmesis and could partially mask the longer term benefits of IMRT at this early stage.

  4. Randomized Controlled Trial of Forward-Planned Intensity Modulated Radiotherapy for Early Breast Cancer: Interim Results at 2 Years

    Energy Technology Data Exchange (ETDEWEB)

    Barnett, Gillian C. [Department of Oncology, University of Cambridge, Cambridge University Hospitals, National Health Service Foundation Trust, Cambridge (United Kingdom); Wilkinson, Jennifer S.; Moody, Anne M.; Wilson, Charles B.; Twyman, Nicola [Oncology Centre, Cambridge University Hospitals, National Health Services Foundation Trust, Cambridge (United Kingdom); Wishart, Gordon C. [Cambridge Breast Unit, Addenbrooke' s Hospital, Cambridge (United Kingdom); Burnet, Neil G. [Department of Oncology, University of Cambridge, Cambridge University Hospitals, National Health Service Foundation Trust, Cambridge (United Kingdom); Coles, Charlotte E., E-mail: charlotte.coles@addenbrookes.nhs.uk [Oncology Centre, Cambridge University Hospitals, National Health Services Foundation Trust, Cambridge (United Kingdom)

    2012-02-01

    Purpose: This single-center randomized trial was designed to investigate whether intensity-modulated radiotherapy (IMRT) reduces late toxicity in patients with early-stage breast cancer. Methods and Materials: The standard tangential plans of 1,145 nonselected patients were analyzed. The patients with inhomogeneous plans were randomized to a simple method of forward-planned IMRT or standard radiotherapy (RT). The primary endpoint was serial photographic assessment of breast shrinkage. Results: At 2 years, no significant difference was found in the development of any photographically assessed breast shrinkage between the patients randomized to the interventional or control group (odds ratio, 1.51; 95% confidence interval, 0.83-1.58; p = .41). The patients in the control group were more likely to develop telangiectasia than those in the IMRT group (odds ratio, 1.68; 95% confidence interval 1.13-2.40; p = .009). Poor baseline surgical cosmesis resulted in poor overall cosmesis at 2 years after RT. In patients who had good surgical cosmesis, those randomized to IMRT were less likely to deteriorate to a moderate or poor overall cosmesis than those in the control group (odds ratio, 0.63; 95% confidence interval, 0.39-1.03, p = .061). Conclusions: IMRT can lead to a significant reduction in telangiectasia at comparatively early follow-up of only 2 years after RT completion. An important component of breast induration and shrinkage will actually result from the surgery and not from the RT. Surgical cosmesis is an important determinant of overall cosmesis and could partially mask the longer term benefits of IMRT at this early stage.

  5. Psychosocial Results from a Phase I Trial of a Nonsurgical Circumcision Device for Adult Men in Zimbabwe.

    Science.gov (United States)

    Kasprzyk, Danuta; Montaño, Daniel E; Hamilton, Deven T; Down, Kayla L; Marrett, Karl D; Tshimanga, Mufuta; Xaba, Sinokuthemba; Mugurungi, Owen

    2016-01-01

    Male circumcision (MC), an effective HIV prevention tool, has been added to Zimbabwe's Ministry of Health and Child Care HIV/AIDS Prevention Program. A Phase I safety trial of a nonsurgical male circumcision device was conducted and extensive psychosocial variables were assessed. Fifty-three men (18 and older) were recruited for the device procedure; 13 follow-up clinical visits were completed. Interviews conducted three times (before the procedure, at 2 weeks and 90 days post-procedure) assessed: Satisfaction; expectations; actual experience; activities of daily living; sexual behavior; and HIV risk perception. Using the Integrated Behavioral Model, attitudes towards MC, sex, and condoms, and sources of social influence and support were also assessed. Men (mean age 32.5, range 18-50; mean years of education = 13.6; 55% employed) were satisfied with device circumcision results. Men understand that MC is only partially protective against HIV acquisition. Most (94.7%) agreed that they will continue to use condoms to protect themselves from HIV. Pain ratings were surprisingly negative for a procedure billed as painless. Men talked to many social networks members about their MC experience; post-procedure (mean of 14 individuals). Minimal impact on activities of daily living and absenteeism indicate possible cost savings of device circumcisions. Spontaneous erections occurred frequently post-procedure. The results had important implications for changes in the pre-procedure clinical counseling protocol. Clear-cut counseling to manage pain and erection expectations should result in improved psychosocial outcomes in future roll-out of device circumcisions. Men's expectations must be managed through evidence-based counseling, as they share their experiences broadly among their social networks. PMID:26745142

  6. Randomized controlled trials of HIV/AIDS prevention and treatment in Africa: results from the Cochrane HIV/AIDS Specialized Register.

    Directory of Open Access Journals (Sweden)

    Babalwa Zani

    Full Text Available INTRODUCTION: To effectively address HIV/AIDS in Africa, evidence on preventing new infections and providing effective treatment is needed. Ideally, decisions on which interventions are effective should be based on evidence from randomized controlled trials (RCTs. Our previous research described African RCTs of HIV/AIDS reported between 1987 and 2003. This study updates that analysis with RCTs published between 2004 and 2008. OBJECTIVES: To describe RCTs of HIV/AIDS conducted in Africa and reported between 2004 and 2008. METHODS: We searched the Cochrane HIV/AIDS Specialized Register in September 2009. Two researchers independently evaluated studies for inclusion and extracted data using standardized forms. Details included location of trials, interventions, methodological quality, location of principal investigators and funders. RESULTS: Our search identified 834 RCTs, with 68 conducted in Africa. Forty-three assessed prevention-interventions and 25 treatment-interventions. Fifteen of the 43 prevention RCTs focused on preventing mother-to-child HIV transmission. Thirteen of the 25 treatment trials focused on opportunistic infections. Trials were conducted in 16 countries with most in South Africa (20, Zambia (12 and Zimbabwe (9. The median sample size was 628 (range 33-9645. Methods used for the generation of the allocation sequence and allocation concealment were adequate in 38 and 32 trials, respectively, and 58 reports included a CONSORT recommended flow diagram. Twenty-nine principal investigators resided in the United States of America (USA and 18 were from African countries. Trials were co-funded by different agencies with most of the funding obtained from USA governmental and non-governmental agencies. Nineteen pharmaceutical companies provided partial funding to 15 RCTs and African agencies co-funded 17 RCTs. Ethical approval was reported in 65 trials and informed consent in 61 trials. CONCLUSION: Prevention trials dominate the trial

  7. Quality of life after radiation therapy of cerebral low-grade gliomas of the adult: results of a randomised Phase III trial on dose response (EORTC trial 22844)

    Energy Technology Data Exchange (ETDEWEB)

    Kiebert, G.M. [MEDTAP International, 27 Gilbert Street, London (United Kingdom); Curran, D. [EORTC Data Centre Brussels (Belgium); Aaronson, N.K. [The Netherlands Cancer Institute, Amsterdam (Netherlands); Bolla, M. [Centre Hospitalier Regional Universitaire, Grenoble (France); Menten, J. [University Hospital Gasthuisberg Leuven (Belgium); Rutten, E.H.J.M. [University Hospital St. Radboud, Nijmegen (Netherlands); Nordman, E. [Turku University Central Hospital, Turku (Finland); Silvestre, M.E. [Hospital Santa Maria, Lisbon (Portugal); Pierart, M. [EORTC Data Centre, Brussels (Belgium); Karim, A.B.M.F. [Free University Hospital, Amsterdam (Netherlands)

    1998-11-01

    In 1985, the EORTC Radiotherapy Co-operative Group launched a randomised phase III study comparing high-dose (59.4 Gy in 6.5 weeks) versus low-dose (45 Gy in 5 weeks) radiotherapy with conventional techniques in patients diagnosed with low-grade cerebral glioma. The primary endpoint of the study was survival. No difference in survival was observed between the two treatment strategies. A quality of life (QoL) questionnaire consisting of 47 items assessing a range of physical, psychological, social, and symptom domains was included in the trial to measure the impact of treatment over time. Patients who received high-dose radiotherapy tended to report lower levels of functioning and more symptom burden following completion of radiotherapy. These group differences were statistically significant for fatigue/malaise and insomnia immediately after radiotherapy and in leisure time and emotional functioning at 7-15 months after randomisation. These findings suggest that for conventional radiotherapy for low-grade cerebral glioma, a schedule of 45 Gy in 5 weeks not only saves valuable resources, but also spares patients a prolonged treatment at no loss of clinical efficacy. (Copyright (c) 1998 Elsevier Science B.V., Amsterdam. All rights reserved.)

  8. Multileaf Collimator Tracking Improves Dose Delivery for Prostate Cancer Radiation Therapy: Results of the First Clinical Trial

    DEFF Research Database (Denmark)

    Colvill, Emma; Booth, Jeremy T; O'Brien, Ricky T;

    2015-01-01

    PURPOSE: To test the hypothesis that multileaf collimator (MLC) tracking improves the consistency between the planned and delivered dose compared with the dose without MLC tracking, in the setting of a prostate cancer volumetric modulated arc therapy trial. METHODS AND MATERIALS: Multileaf...... collimator tracking was implemented for 15 patients in a prostate cancer radiation therapy trial; in total, 513 treatment fractions were delivered. During each treatment fraction, the prostate trajectory and treatment MLC positions were collected. These data were used as input for dose reconstruction...

  9. Comparison of results from different imputation techniques for missing data from an anti-obesity drug trial

    DEFF Research Database (Denmark)

    Jørgensen, Anders W.; Lundstrøm, Lars H; Wetterslev, Jørn;

    2014-01-01

    of handling missing data in a 60-week placebo controlled anti-obesity drug trial on topiramate. METHODS: We compared an analysis of complete cases with datasets where missing body weight measurements had been replaced using three different imputation methods: LOCF, baseline carried forward (BOCF) and MI....... In anti-obesity drug trials, many data are usually missing, and the most used imputation method is last observation carried forward (LOCF). LOCF is generally considered conservative, but there are more reliable methods such as multiple imputation (MI). OBJECTIVES: To compare four different methods...

  10. Probiotics are effective in alleviating infantile colic; results of a randomized controlled trial held at benazir bhutto hospital rawalpindi, pakistan

    International Nuclear Information System (INIS)

    Objectives: This study aimed to assess the role of probiotics in alleviating infantile colic (IC) while targeting local population. In case of a positive outcome, its use could be suggested in pediatric health care facilities. Methodology: It was a non-blinded randomized control trial conducted at the department of pediatrics, Benazir Bhutto Hospital, Rawalpindi from 4th October 2012 to 3rd April 2013. Through non-probability consecutive sampling we included breast-fed infants of either sex of age 3 weeks (21 days) to 3 months (90 days) diagnosed with IC based on Wessel description. We divided them into two groups i.e. group-A and B who were given probiotics containing Lactobacillus reuteri and simethicone respectively. Results: Of 90 children, 45 children were in each group. Group-A had a mean age 48 ± 17 days and group-B had a mean age 50 ± 17 days. Maximum infants were in sub-group 21 - 45 days (55.6% and 51.1% respectively) in both the groups. The male gender dominated both groups (64.4% and 57.7% respectively). Significantly large percentage (p<0.001) of infants in group-A (86.7%) reached the landmark set for the efficacy confirmation than group-B (51.1%). The mean crying time for the group-A (39 ± 53 minutes) at the end of treatment was significantly shorter (p<0.001) than that of group-B (113 ± 54 minutes). No side effect was reported in the whole sample. Conclusion: Probiotics containing Lactobacillus reuteri significantly improved symptoms in managing IC than simethicaone with no side effects. (author)

  11. Gemcitabine and irinotecan as first-line therapy for carcinoma of unknown primary: results of a multicenter phase II trial.

    Directory of Open Access Journals (Sweden)

    Shernan G Holtan

    Full Text Available Metastatic carcinoma of unknown primary (CUP has a very poor prognosis, and no standard first-line therapy currently exists. Here, we report the results of a phase II study utilizing a combination of gemcitabine and irinotecan as first-line therapy. Treatment was with gemcitabine 1000 mg/m(2 and irinotecan 75 mg/m(2 weekly times four on a six week cycle (Cohort I. Due to excessive toxicity, the dose and schedule were modified as follows: gemcitabine 750 mg/m(2 and irinotecan 75 mg/m(2 given weekly times three on a four week cycle (Cohort II. The primary endpoint was the confirmed response rate (CR + PR. Secondary endpoints consisted of adverse events based upon the presence or absence of the UDP glucuronosyltransferase 1 family, polypeptide A1*28 (UGT1A1*28 polymorphism, time to progression, and overall survival. Thirty-one patients were enrolled with a median age of 63 (range: 38-94, and 26 patients were evaluable for efficacy. Significant toxicity was observed in Cohort 1, characterized by 50% (7/14 patients experiencing a grade 4+ adverse event, but not in cohort II. The confirmed response rate including patients from both cohorts was 12% (95% CI: 2-30%, which did not meet the criteria for continued enrollment. Overall median survival was 7.2 months (95% CI: 4.0 to 11.6 for the entire cohort but notably longer in cohort II than in cohort I (9.3 months (95% CI: 4.1 to 12.1 versus 4.0 months (95% CI: 2.2 to 15.6. Gemcitabine and irinotecan is not an active combination when used as first line therapy in patients with metastatic carcinoma of unknown primary. Efforts into developing novel diagnostic and therapeutic approaches remain important for improving the outlook for this heterogeneous group of patients.ClinicalTrials.gov NCT00066781.

  12. Effects of music therapy on pain among female breast cancer patients after radical mastectomy: results from a randomized controlled trial.

    Science.gov (United States)

    Li, Xiao-Mei; Yan, Hong; Zhou, Kai-Na; Dang, Shao-Nong; Wang, Duo-Lao; Zhang, Yin-Ping

    2011-07-01

    Music therapy has been used in multiple health care settings to reduce patient pain, anxiety, and stress. However, few available studies have investigated its effect on pain among breast cancer patients after radical mastectomy. The aim of this study was to explore the effects of music therapy on pain reduction in patients with breast cancer after radical mastectomy. This randomized controlled trial was conducted at the Surgical Department of Oncology Center, First Affiliated Hospital of Xi'an Jiaotong University from March to November 2009. A total of 120 breast cancer patients who received Personal Controlled Analgesia (PCA) following surgery (mastectomy) were randomly allocated to two groups, an intervention group and a control group (60 patients in each group). The intervention group accepted music therapy from the first day after radical mastectomy to the third admission to hospital for chemotherapy in addition to the routine nursing care, while the control group received only routine nursing care. Pain scores were measured at baseline and three post-tests using the General Questionnaire and Chinese version of Short-Form of McGill Pain Questionnaire. The primary endpoint was the change in the Pain Rating Index (PRI-total) score from baseline. Music therapy was found to reduce the PRI-total score in the intervention group significantly compared with the control group with a mean difference (95% CI) of -2.38 (-2.80, -1.95), -2.41 (-2.85, -1.96), and -1.87 (-2.33, -1.42) for the 1st, 2nd, and 3rd post-tests, respectively. Similar results were found for Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) scores. The findings of the study provide some evidence that music therapy has both short- and long-term positive effects on alleviating pain in breast cancer patients following radical mastectomy. PMID:21537935

  13. Effectiveness of a low-threshold physical activity intervention in residential aged care – results of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Cichocki M

    2015-05-01

    Full Text Available Martin Cichocki,1 Viktoria Quehenberger,1 Michael Zeiler,1 Tanja Adamcik,1 Matthias Manousek,1 Tanja Stamm,2 Karl Krajic1 1Ludwig Boltzmann Institute Health Promotion Research, 2Medical University of Vienna & University of Applied Sciences FH Campus, Wien, Vienna, Austria Purpose: Research on effectiveness of low-threshold mobility interventions that are viable for users of residential aged care is scarce. Low-threshold is defined as keeping demands on organizations (staff skills, costs and participants (health status, discipline rather low. The study explored the effectiveness of a multi-faceted, low-threshold physical activity program in three residential aged-care facilities in Austria. Main goals were enhancement of mobility by conducting a multi-faceted training program to foster occupational performance and thus improve different aspects of health-related quality of life (QoL.Participants and methods: The program consisted of a weekly session of 60 minutes over a period of 20 weeks. A standardized assessment of mobility status and health-related QoL was applied before and after the intervention. A total of 222 of 276 participants completed the randomized controlled trial study (intervention group n=104, control group n=118; average age 84 years, 88% female.Results: Subjective health status (EuroQoL-5 dimensions: P=0.001, d=0.36 improved significantly in the intervention group, and there were also positive trends in occupational performance (Canadian Occupational Performance Measure. No clear effects were found concerning the functional and cognitive measures applied.Conclusion: Thus, the low-threshold approach turned out to be effective primarily on subjective health-related QoL. This outcome could be a useful asset for organizations offering low-threshold physical activity interventions. Keywords: physical activity, intervention, residential aged care, effectiveness, aged

  14. The Potential for Mindfulness-Based Intervention in Workplace Mental Health Promotion: Results of a Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Shu-Ling Huang

    Full Text Available This study aims to intensively evaluate the effectiveness of mindfulness-based intervention (MBI on mental illness risks (including psychological distress, prolonged fatigue, and perceived stress and job strain (job control and job demands for employees with poor mental health.A longitudinal research design was adopted. In total, 144 participants were randomized to the intervention group or the control group. The intervention group participated in MBI for eight weeks. Measurements were collected for both groups at five time points: at pre-intervention (T1, at mid-intervention (T2, at the completion of intervention (T3, four weeks after intervention (T4, and eight weeks after intervention (T5. Data were analyzed according to the intention-to-treat principle. A linear mixed model with two levels was employed to analyze the repeated measurement data.Compared with the control group, the intercepts (means at T3 for the intervention group were significantly lower on psychological distress, prolonged fatigue, and perceived stress when MBI was completed. Even with the demographic variables controlled, the positive effects remained. For growth rates of prolonged fatigue and perceived stress, participants in the intervention group showed a steeper decrease than did the participants in the control group. Regarding job strain, although the intercept (mean at T3 of job demands showed a significant decline when BMI was completed, the significance disappeared when the demographic variables were controlled. Moreover, the other results for job control and job demands did not show promising findings.As a workplace health promotion program, the MBI seems to have potential in improving mental illness risks for employees with poor mental health. However, there was insufficient evidence to support its effect on mitigating job strain. Further research on maintaining the positive effects on mental health for the long term and on developing innovative MBI to suit job

  15. Relationship Between Time in Therapeutic Range and Comparative Treatment Effect of Rivaroxaban and Warfarin: Results From the ROCKET AF Trial

    Science.gov (United States)

    Piccini, Jonathan P.; Hellkamp, Anne S.; Lokhnygina, Yuliya; Patel, Manesh R.; Harrell, Frank E.; Singer, Daniel E.; Becker, Richard C.; Breithardt, Günter; Halperin, Jonathan L.; Hankey, Graeme J.; Berkowitz, Scott D.; Nessel, Christopher C.; Mahaffey, Kenneth W.; Fox, Keith A. A.; Califf, Robert M.

    2014-01-01

    Background Time in therapeutic range (TTR) is a standard quality measure of the use of warfarin. We assessed the relative effects of rivaroxaban versus warfarin at the level of trial center TTR (cTTR) since such analysis preserves randomized comparisons. Methods and Results TTR was calculated using the Rosendaal method, without exclusion of international normalized ratio (INR) values performed during warfarin initiation. Measurements during warfarin interruptions >7 days were excluded. INRs were performed via standardized finger‐stick point‐of‐care devices at least every 4 weeks. The primary efficacy endpoint (stroke or non‐central nervous system embolism) was examined by quartiles of cTTR and by cTTR as a continuous function. Centers with the highest cTTRs by quartile had lower‐risk patients as reflected by lower CHADS2 scores (P<0.0001) and a lower prevalence of prior stroke or transient ischemic attack (P<0.0001). Sites with higher cTTR were predominantly from North America and Western Europe. The treatment effect of rivaroxaban versus warfarin on the primary endpoint was consistent across a wide range of cTTRs (P value for interaction=0.71). The hazard of major and non‐major clinically relevant bleeding increased with cTTR (P for interaction=0.001), however, the estimated reduction by rivaroxaban compared with warfarin in the hazard of intracranial hemorrhage was preserved across a wide range of threshold cTTR values. Conclusions The treatment effect of rivaroxaban compared with warfarin for the prevention of stroke and systemic embolism is consistent regardless of cTTR. PMID:24755148

  16. Clinical trial results of a modified gore excluder endograft: comparison with open repair and original device design.

    Science.gov (United States)

    Curci, John A; Fillinger, Mark F; Naslund, Thomas C; Rubin, Brian G

    2007-05-01

    A multicenter phase II clinical trial of aneurysm treatment was performed with the modified Gore Excluder bifurcated endoprosthesis (m-EBE, n = 193) and compared with previously reported results from the same group of the original unmodified device (EBE, n = 253) or standard open aneurysm exclusion (control, n = 99). Graft modifications were primarily related to the proximal attachment site and included an increase in the length of the external expanded polytetrafluoroethylene and modifications of the anchor configuration. Preprocedural characteristics, periprocedural clinical events, and postprocedural clinical and radiographic follow-up at 1, 6, 12, and 24 months were analyzed with univariate and multivariate statistics. Device placement was successful in all cases, and there were no aneurysm ruptures in any group. Survival to 2 years was similar in all groups. Early major adverse events with the m-EBE were similar to those with the EBE (14.5% vs. 14%, P = 0.9) and markedly reduced compared to the control group (60.6%, P EBE (2% vs. 6% with the EBE, P EBE compared to the EBE during 14- to 28-month follow-up (15.6% vs. 24.9%, P = 0.037), in part due to the difference in reinterventions. The safety and efficacy of the m-EBE are statistically similar to the original device, although there was a reduction in major late adverse events between the two iterations of the endograft. This difference appears to be related to increased operator experience and changing treatment algorithms. Compared with open aneurysm repair, endoluminal repair with the m-EBE offers advantages in the reduction of early major adverse events while maintaining similar survival and rupture-free outcomes in the intermediate term.

  17. Technical quality assurance during the TROG 03.04 RADAR prostate radiotherapy trial: are the results reflected in observed toxicity rates?

    International Nuclear Information System (INIS)

    Multicentre radiotherapy clinical trials can incorporate quality assurance (QA) procedures for ensuring consistent application of the trial protocol in the planning, delivery and reporting of participant treatments. Subsequently detected variations from trial protocol have previously been shown to reduce treatment efficacy, although little has been shown for toxicity rates. The purpose of this study was to investigate the association of QA measures and protocol variations on toxicity incidence in the context of a prostate radiotherapy trial. Using QA records from the TROG 03.04 RADAR trial, the impact of variations on gastrointestinal (GI) and genito-urinary (GU) toxicities was investigated. Protocol variation rates were lower than reported in previous studies, and showed little correlation with GI toxicity outcomes. Variations classified as ‘major’ showed a non-significant trend for increased toxicity relative to those classified as ‘minor’. Results from a Level III phantom-based dosimetry study showed some correlation with GI toxicity, whereas ranking on a set-up accuracy study did not impact on toxicity. Toxicity in general increased with the number of participants accrued per centre, at odds with previous reports relating to disease progression, with a potential link to increases in low–mid-range rectal doses in the cohort from higher-accruing centres. No QA-related variables correlated with GU toxicities. Besides non-significant trends, minimal association was observed between QA variables and toxicity rates for the RADAR trial. The intention of the trial's QA programme was to reduce treatment variations and minimise toxicity in the context of a relevantly advanced treatment approach.

  18. Relative Cost-Effectiveness of Treatments for Adolescent Depression: 36-Week Results from the TADS Randomized Trial

    Science.gov (United States)

    Domino, Marisa Elena; Foster, E. Michael; Vitiello, Benedetto; Kratochvil, Christopher J.; Burns, Barbara J.; Silva, Susan G.; Reinecke, Mark A.; March, John S.

    2009-01-01

    Randomized controlled trials that involve 327 participants aged 12 to 18 who were diagnosed with major depression were given either fluoxetine alone, cognitive-behavioral therapy, or a combination of both. Cost-effectiveness acceptability curves suggest that combination treatment is highly likely to be the most cost-effective treatment than…

  19. ORGANIC AUDIT REPOSITORY AND RESULTS OF PERFORMANCE AUDITS DURING HAZARDOUS WASTE TRIAL BURNS AND COMPLIANCE SOURCE TESTS

    Science.gov (United States)

    A repository has been established by EPA to provide audit materials to federal, state and local agencies or their contractors for use in performance audits to assess the accuracy of measurement methods used during (1) hazardous waste trial burns, (2) compliance source testing, an...

  20. The effectiveness of participatory ergonomics to prevent low-back and neck pain - results of a cluster randomized controlled trial

    NARCIS (Netherlands)

    Driessen, M.T.; Proper, K.I.; Anema, J.R.; Knol, D.L.; Bongers, P.M.; Beek, A.J. van der

    2011-01-01

    Objective The aim of this randomized controlled trial (RCT) was to investigate the effectiveness of the Stay@ Work participatory ergonomics (PE) program to prevent low-back and neck pain. Methods A total of 37 departments were randomly allocated to either the intervention (PE) or control group (no P

  1. Predictors of employment for people with severe mental illness : results of an international six-centre randomised controlled trial

    NARCIS (Netherlands)

    Catty, Jocelyn; Lissouba, Pascale; White, Sarah; Becker, Thomas; Drake, Robert E.; Fioritti, Angelo; Knapp, Martin; Lauber, Christoph; Roessler, Wulf; Tomov, Toma; Van Busschbach, Jooske; Wiersma, Durk; Burns, Tom; Rossler, W.

    2008-01-01

    Background An international six-centre randomised controlled trial comparing individual placement and support (IPS) with usual vocational rehabilitation for people with serious mental illness found IPS to be more effective for all vocational outcomes. Aims To determine which patients with severe men

  2. No benefit of intraoperative whole blood sequestration and autotransfusion during coronary artery bypass grafting : results of a randomized clinical trial

    NARCIS (Netherlands)

    Ramnath, A N; Naber, H R; de Boer, A; Leusink, J A

    2003-01-01

    OBJECTIVES: In a randomized clinical trial of patients undergoing elective coronary artery bypass grafting, we evaluated the effect of intraoperative whole blood sequestration and autotransfusion on postoperative blood loss and the use of allogeneic blood products. METHODS: Male patients were includ

  3. Off-label use of recombinant factor VIIa for treatment of haemorrhage: results from randomized clinical trials

    DEFF Research Database (Denmark)

    Johansson, Per Ingemar

    2008-01-01

    Background Recombinant factor VIIa (rFVIIa) is used for haemophilic patients with inhibitors against coagulation factor VIII or IX, but there is also an off-label use of rFVIIa for patients with massive bleeding. The aim of the present study was to review the randomized clinical trials (RCT...

  4. Placebo response in antipsychotic trials of patients with acute mania : Results of an individual patient data meta-analysis

    NARCIS (Netherlands)

    Welten, C C M; Koeter, M W J; Wohlfarth, T; Storosum, J G; van den Brink, W; Gispen-de Wied, C C; Leufkens, H G M; Denys, D A J P

    2015-01-01

    We examined the role of placebo response in acute mania trials. Specifically, whether placebo response: (1) predicts treatment effect, (2) can be predicted by patient and study characteristics, and (3) can be predicted by a parsimonious model. We performed a meta-analysis of individual patient data

  5. A Step Forward in Molecular Diagnostics of Lyssaviruses – Results of a Ring Trial among European Laboratories

    DEFF Research Database (Denmark)

    Fischer, Melina; Wernike, Kerstin; Freuling, Conrad M.;

    2013-01-01

    Rabies is a lethal and notifiable zoonotic disease for which diagnostics have to meet the highest standards. In recent years, an evolution was especially seen in molecular diagnostics with a wide variety of different detection methods published. Therefore, a first international ring trial specifi...

  6. A Step Forward in Molecular Diagnostics of Lyssaviruses – Results of a Ring Trial among European Laboratories

    NARCIS (Netherlands)

    Fischer, M.; Wernike, K.; Freuling, C.M.; Müller, T.; Aylan, O.; Brochier, B.; Cliquet, F.; Vázquez-Morón, S.; Hostnik, P.; Huovilainen, A.; Isaksson, M.; Kooi, E.A.

    2013-01-01

    Rabies is a lethal and notifiable zoonotic disease for which diagnostics have to meet the highest standards. In recent years, an evolution was especially seen in molecular diagnostics with a wide variety of different detection methods published. Therefore, a first international ring trial specifical

  7. Venlafaxine ER for the Treatment of Pediatric Subjects with Depression: Results of Two Placebo-Controlled Trials

    Science.gov (United States)

    Emslie, Graham J.; Findling, Robert L.; Yeung, Paul P.; Kunz, Nadia R.; Li, Yunfeng

    2007-01-01

    Objective: The safety, efficacy, and tolerability of venlafaxine extended release (ER) in subjects ages 7 to 17 years with major depressive disorder were evaluated in two multicenter, randomized, double-blind, placebo-controlled trials conducted between October 1997 and August 2001. Method: Participants received venlafaxine ER (flexible dose,…

  8. Effects of Cognitive Enhancement Therapy on Employment Outcomes in Early Schizophrenia: Results from a 2-Year Randomized Trial

    Science.gov (United States)

    Eack, Shaun M.; Hogarty, Gerard E.; Greenwald, Deborah P.; Hogarty, Susan S.; Keshavan, Matcheri S.

    2011-01-01

    Objective: To examine the effects of psychosocial cognitive rehabilitation on employment outcomes in a randomized controlled trial for individuals with early course schizophrenia. Method: Early course schizophrenia outpatients (N = 58) were randomly assigned to cognitive enhancement therapy (CET) or an enriched supportive therapy (EST) control and…

  9. Defining the Optimal Planning Target Volume in Image-Guided Stereotactic Radiosurgery of Brain Metastases: Results of a Randomized Trial

    Energy Technology Data Exchange (ETDEWEB)

    Kirkpatrick, John P., E-mail: john.kirkpatrick@dm.duke.edu [Department of Radiation Oncology, Duke University, Durham, North Carolina (United States); Department of Surgery, Duke University, Durham, North Carolina (United States); Wang, Zhiheng [Department of Radiation Oncology, Duke University, Durham, North Carolina (United States); Sampson, John H. [Department of Radiation Oncology, Duke University, Durham, North Carolina (United States); Department of Surgery, Duke University, Durham, North Carolina (United States); McSherry, Frances; Herndon, James E. [Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina (United States); Allen, Karen J.; Duffy, Eileen [Department of Radiation Oncology, Duke University, Durham, North Carolina (United States); Hoang, Jenny K. [Department of Radiology, Duke University, Durham, North Carolina (United States); Chang, Zheng; Yoo, David S.; Kelsey, Chris R.; Yin, Fang-Fang [Department of Radiation Oncology, Duke University, Durham, North Carolina (United States)

    2015-01-01

    Purpose: To identify an optimal margin about the gross target volume (GTV) for stereotactic radiosurgery (SRS) of brain metastases, minimizing toxicity and local recurrence. Methods and Materials: Adult patients with 1 to 3 brain metastases less than 4 cm in greatest dimension, no previous brain radiation therapy, and Karnofsky performance status (KPS) above 70 were eligible for this institutional review board–approved trial. Individual lesions were randomized to 1- or 3- mm uniform expansion of the GTV defined on contrast-enhanced magnetic resonance imaging (MRI). The resulting planning target volume (PTV) was treated to 24, 18, or 15 Gy marginal dose for maximum PTV diameters less than 2, 2 to 2.9, and 3 to 3.9 cm, respectively, using a linear accelerator–based image-guided system. The primary endpoint was local recurrence (LR). Secondary endpoints included neurocognition Mini-Mental State Examination, Trail Making Test Parts A and B, quality of life (Functional Assessment of Cancer Therapy-Brain), radionecrosis (RN), need for salvage radiation therapy, distant failure (DF) in the brain, and overall survival (OS). Results: Between February 2010 and November 2012, 49 patients with 80 brain metastases were treated. The median age was 61 years, the median KPS was 90, and the predominant histologies were non–small cell lung cancer (25 patients) and melanoma (8). Fifty-five, 19, and 6 lesions were treated to 24, 18, and 15 Gy, respectively. The PTV/GTV ratio, volume receiving 12 Gy or more, and minimum dose to PTV were significantly higher in the 3-mm group (all P<.01), and GTV was similar (P=.76). At a median follow-up time of 32.2 months, 11 patients were alive, with median OS 10.6 months. LR was observed in only 3 lesions (2 in the 1 mm group, P=.51), with 6.7% LR 12 months after SRS. Biopsy-proven RN alone was observed in 6 lesions (5 in the 3-mm group, P=.10). The 12-month DF rate was 45.7%. Three months after SRS, no significant change in

  10. Impact of a parent-child sexual communication campaign: results from a controlled efficacy trial of parents

    Directory of Open Access Journals (Sweden)

    Evans W Douglas

    2010-07-01

    Full Text Available Abstract Background Prior research supports the notion that parents have the ability to influence their children's decisions regarding sexual behavior. Yet parent-based approaches to curbing teen pregnancy and STDs have been relatively unexplored. The Parents Speak Up National Campaign (PSUNC is a multimedia campaign that attempts to fill this void by targeting parents of teens to encourage parent-child communication about waiting to have sex. The campaign follows a theoretical framework that identifies cognitions that are targeted in campaign messages and theorized to influence parent-child communication. While a previous experimental study showed PSUNC messages to be effective in increasing parent-child communication, it did not address how these effects manifest through the PSUNC theoretical framework. The current study examines the PSUNC theoretical framework by 1 estimating the impact of PSUNC on specific cognitions identified in the theoretical framework and 2 examining whether those cognitions are indeed associated with parent-child communication Methods Our study consists of a randomized efficacy trial of PSUNC messages under controlled conditions. A sample of 1,969 parents was randomly assigned to treatment (PSUNC exposure and control (no exposure conditions. Parents were surveyed at baseline, 4 weeks, 6 months, 12 months, and 18 months post-baseline. Linear regression procedures were used in our analyses. Outcome variables included self-efficacy to communicate with child, long-term outcome expectations that communication would be successful, and norms on appropriate age for sexual initiation. We first estimated multivariable models to test whether these cognitive variables predict parent-child communication longitudinally. Longitudinal change in each cognitive variable was then estimated as a function of treatment condition, controlling for baseline individual characteristics. Results Norms related to appropriate age for sexual

  11. Long-term results of the randomized phase III trial EORTC 18991 of adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma

    NARCIS (Netherlands)

    A.M.M. Eggermont (Alexander); S. Suciu (Stefan); A. Testori (Alessandro); M. Santinami (Mario); W.H.J. Kruit (Wim); J. Marsden; C.J.A. Punt (Cornelis); F. Salès (François); R. Dummer (Reinhard); C. Robert (Caroline); D. Schadendorf (Dirk); P. Patel (Poulam); G. de Schaetzen (Gaetan); A. Spatz (Alan); U. Keilholz (Ulrich)

    2012-01-01

    textabstractPurpose: Adjuvant pegylated interferon alfa-2b (PEG-IFN-α-2b) was approved for treatment of resected stage III melanoma in 2011. Here, we present long-term follow-up results of this pivotal trial. Patients and Methods: In all, 1,256 patients with resected stage III melanoma were randomly

  12. Air conditioning using an air-cooled single effect lithium bromide absorption chiller: results of a trial conducted in Madrid in August 2005

    OpenAIRE

    Izquierdo, M.; Lizarte, R.; Marcos, J.D.; Gutiérrez, G.

    2008-01-01

    Air conditioning using an air-cooled single effect lithium bromide absorption chiller: results of a trial conducted in Madrid in August 2005 correspondence: Corresponding author. Tel.: + 34 91 871 32 48; fax: + 34 91 871 32 48. (Izquierdo, M.) (Izquierdo, M.) Instituto de Ciencias de la Construccion Eduardo Torroja (CSIC) c/Serrano Galvache 4 - 28033 Madrid--> - SPAIN (Izquierdo, M.) SPAIN (Izquierdo, M.)...

  13. Outcome of transcutaneous electrical nerve stimulation in chronic pain: short-term results of a double-blind, randomised, placebo-controlled trial.

    NARCIS (Netherlands)

    Oosterhof, J.; Boo, T.M. de; Oostendorp, R.A.B.; Wilder-Smith, O.H.G.; Crul, B.J.P.

    2006-01-01

    The aim of this study was to test the efficacy of shortterm transcutaneous electrical nerve stimulation (TENS) treatment in chronic pain with respect to pain intensity and patients' satisfaction with treatment results. We therefore performed a randomised controlled trial comparing TENS and sham TENS

  14. The treatment of disc herniation-induced sciatica with infliximab - One-year follow-up results of FIRST II, a randomized controlled trial

    NARCIS (Netherlands)

    Korhonen, Timo; Karppinen, Jaro; Paimela, Leena; Malmivaara, Antti; Lindgren, Karl-August; Bowman, Chris; Hammond, Anthony; Kirkham, Bruce; Jarvinen, Simo; Niinimaki, Jaakko; Veeger, Nic; Haapea, Marianne; Torkki, Markus; Tervonen, Osmo; Seitsalo, Seppo; Hurri, Heikki

    2006-01-01

    Study Design. A randomized controlled trial. Objectives. To evaluate the long-term efficacy of infliximab, a monoclonal antibody against tumor necrosis factor alpha (TNF-alpha), in patients with acute/subacute sciatica secondary to herniated disc. Summary of Background Data. The results of experimen

  15. Smoking cessation intervention within the framework of a lung cancer screening program: preliminary results and clinical perspectives from the "Cosmos-II" Trial.

    Science.gov (United States)

    Filippo, Lococo; Principe, Rosastella; Cesario, Alfredo; Apolone, Giovanni; Carleo, Francesco; Ialongo, Pasquale; Veronesi, Giulia; Cardillo, Giuseppe

    2015-02-01

    Data coming from the literature investigating the effectiveness and interaction between smoking cessation (SC) and lung cancer screening (LCScr) are still sparse and inconsistent. Herein, we report the preliminary results from the ongoing lung cancer screening trial ("Cosmos-II") focusing our analysis on the inter-relationship between the SC program and the LCScr.

  16. Two-year results of a prospective preventive swallowing rehabilitation trial in patients treated with chemoradiation for advanced head and neck cancer

    NARCIS (Netherlands)

    L. van der Molen; M. van Rossum; C.R.N. Rasch; L.E. Smeele; F.J.M. Hilgers

    2013-01-01

    The objective of the study was the assessment of the results of a prospective clinical trial with two preventive swallowing rehabilitation programs on the long-term side effects of chemoradiotherapy (CCRT) in advanced head and neck cancer patients. The study cohort consisted of 29 patients, randomiz

  17. Effectiveness of an Internet intervention for family caregivers of people with dementia: results of a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Marco M Blom

    Full Text Available The World Health Organization stresses the importance of accessible and (costeffective caregiver support, given the expected increase in the number of people with dementia and the detrimental impact on the mental health of family caregivers.This study assessed the effectiveness of the Internet intervention 'Mastery over Dementia'. In a RCT, 251 caregivers, of whom six were lost at baseline, were randomly assigned to two groups. Caregivers in the experimental group (N = 149 were compared to caregivers who received a minimal intervention consisting of e-bulletins (N = 96. Outcomes were symptoms of depression (Center for Epidemiologic Studies Depression Scale: CES-D and anxiety (Hospital Anxiety and Depression Scale: HADS-A. All data were collected via the Internet, and an intention-to-treat analysis was carried out.Almost all caregivers were spouses or children (in-law. They were predominantly female and lived with the care recipient in the same household. Age of the caregivers varied from 26 to 87 years. Level of education varied from primary school to university, with almost half of them holding a bachelor's degree or higher. Regression analyses showed that caregivers in the experimental group showed significantly lower symptoms of depression (p = .034 and anxiety (p = .007 post intervention after adjustment for baseline differences in the primary outcome scores and the functional status of the patients with dementia. Effect sizes were moderate for symptoms of anxiety (.48 and small for depressive symptoms (.26.The Internet course 'Mastery over Dementia' offers an effective treatment for family caregivers of people with dementia reducing symptoms of depression and anxiety. The results of this study justify further development of Internet interventions for family caregivers of people with dementia and suggest that such interventions are promising for keeping support for family caregivers accessible and affordable. The findings are even more

  18. Correlates of pedometer use: Results from a community-based physical activity intervention trial (10,000 Steps Rockhampton

    Directory of Open Access Journals (Sweden)

    Schofield Grant

    2007-07-01

    Full Text Available Abstract Background Pedometers have become common place in physical activity promotion, yet little information exists on who is using them. The multi-strategy, community-based 10,000 Steps Rockhampton physical activity intervention trial provided an opportunity to examine correlates of pedometer use at the population level. Methods Pedometer use was promoted across all intervention strategies including: local media, pedometer loan schemes through general practice, other health professionals and libraries, direct mail posted to dog owners, walking trail signage, and workplace competitions. Data on pedometer use were collected during the 2-year follow-up telephone interviews from random population samples in Rockhampton, Australia, and a matched comparison community (Mackay. Logistic regression analyses were used to determine the independent influence of interpersonal characteristics and program exposure variables on pedometer use. Results Data from 2478 participants indicated that 18.1% of Rockhampton and 5.6% of Mackay participants used a pedometer in the previous 18-months. Rockhampton pedometer users (n = 222 were more likely to be female (OR = 1.59, 95% CI: 1.11, 2.23, aged 45 or older (OR = 1.69, 95% CI: 1.16, 2.46 and to have higher levels of education (university degree OR = 4.23, 95% CI: 1.86, 9.6. Respondents with a BMI > 30 were more likely to report using a pedometer (OR = 1.68, 95% CI: 1.11, 2.54 than those in the healthy weight range. Compared with those in full-time paid work, respondents in 'home duties' were significantly less likely to report pedometer use (OR = 0.18, 95% CI: 0.06, 0.53. Exposure to individual program components, in particular seeing 10,000 Steps street signage and walking trails or visiting the website, was also significantly associated with greater pedometer use. Conclusion Pedometer use varies between population subgroups, and alternate strategies need to be investigated to engage men, people with lower levels

  19. Long-term results of a randomized controlled trial evaluating preoperative chemotherapy in resectable non-small cell lung cancer

    Directory of Open Access Journals (Sweden)

    Chen ZW

    2013-06-01

    Full Text Available Zhiwei Chen,* Qingquan Luo,* Hong Jian, Zhen Zhou, Baijun Cheng, Shun Lu, Meilin LiaoShanghai Lung Tumor Clinical Medical Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, People’s Republic of China *These authors contributed equallyObjective: We aimed to evaluate whether preoperative chemotherapy provides benefits in the survival and prognosis of patients with non-small cell lung cancer (NSCLC in resectable stages I to IIIA, except T1N0. Methods: In this randomized, controlled trial, 356 patients with stage I (except for T1N0, II and IIIA NSCLC were assigned to either the preoperative chemotherapy plus surgery arm (179 patients or the primary surgery arm (177 patients. Both treatments were followed by adjuvant chemotherapy. The end point of this study included overall survival (OS, progression-free survival (PFS, and survival rate associated with clinical remission. Results: Statistical survival difference was found between the preoperative chemotherapy plus surgery arm and the surgery-alone arm. However, the median survival time (MST in the preoperative chemotherapy arm was lower than that of surgery-alone arm (MST, 45.42 months vs 57.59 months (P = 0.016. When comparing the effect of preoperative chemotherapy at each stage of NSCLC, a statistical survival difference was found in stage II NSCLC but not in stage I and IIIA (MST 40.86 months vs 80.81 months (P = 0.044. However, no statistically significant difference in PFS was noticed between the two arms, except for stage I NSCLC (hazard radio [HR] = 0.87; 95% CI, 0.561−1.629; P = 0.027. The survival rate was higher for patients who had clinical remission after preoperative chemotherapy, but the differences did not reach statistical significance (MST 42.10 months vs 35.33 months (P = 0.630. Conclusion: Preoperative chemotherapy did not show benefits in OS and PFS for stage I-IIIA NSCLC patients. Keywords: NSCLC, neoadjuvent, mitomycin, cisplatin, vindesine

  20. THE FIRST RUSSIAN STRATEGIC STUDY OF PHARMACOTHERAPY FOR RHEUMATOID ARTHRITIS (REMARCA TRIAL: RESULTS OF 12-MONTH TREATMENT IN 130 PATIENTS

    Directory of Open Access Journals (Sweden)

    D. E. Karateev

    2014-01-01

    Full Text Available To introduce treat-to-target recommendations is an important task of modern rheumatology; however, there is still a diversity of serious problems relating to a scientific rationale and a clinical one for this strategy and to the possibilities of its implementation in real clinical practice, in the rheumatology service of the Russian Federation in particular, by taking into account the specific features of funding for high-tech medical care.Objective: to determine the efficiency and safety of combined therapy with subcutaneous methotrexate (MT and biological agents (BA when using the treat-to-target strategy in patients with active early and extended-stage rheumatoid arthritis (RA who have risk factors for a poor prognosis.Subjects and methods.The results of the REMARCA (Russian InvEstigation of MethotrexAte and biologicals in eaRly aCtive inflammatory Arthritis trial of 130 patients followed up for 12 months or more were given. There was a female preponderance; mean age 48.9±13.9 years, rheumatoid factor positivity (86.9%; anti-cyclic citrullinated peptide antibody positivity (89.2%. Seventy patients formed a subgroup of early RA (disease duration ≤6 months (mean 4.17±1.39 months; 60 patients were a subgroup of advanced-stage RA (disease duration >6 months (mean 30.8±32.7 months. In all the patients, therapy was initiated by using subcutaneous MT with its rapid dose escalation up to 20–30 mg/week and the achievement of the treatment goal (low disease activity or remission was checked every 3 months and depending on the result a decision had been taken to add or not to add a biological agent (BA (a tumor necrosis factor inhibitor or abatacept. If the former was insufficiently effective, it was substituted for a BA from another class.Results. Subcutaneous MT monotherapy provided remission or low disease activity in 49 (37.7% patients; a BA was given to 81 (62.3% patients. Following 6 and 12 months, low activity or remission

  1. THE FIRST RUSSIAN STRATEGIC STUDY OF PHARMACOTHERAPY FOR RHEUMATOID ARTHRITIS (REMARCA TRIAL: RESULTS OF 12-MONTH TREATMENT IN 130 PATIENTS

    Directory of Open Access Journals (Sweden)

    D. E. Karateev

    2015-01-01

    Full Text Available To introduce treat-to-target recommendations is an important task of modern rheumatology; however, there is still a diversity of serious problems relating to a scientific rationale and a clinical one for this strategy and to the possibilities of its implementation in real clinical practice, in the rheumatology service of the Russian Federation in particular, by taking into account the specific features of funding for high-tech medical care. Objective: to determine the efficiency and safety of combined therapy with subcutaneous methotrexate (MT and biological agents (BA when using the treat-to-target strategy in patients with active early and extended-stage rheumatoid arthritis (RA who have risk factors for a poor prognosis. Subjects and methods. The results of the REMARCA (Russian InvEstigation of MethotrexAte and biologicals in eaRly aCtive inflammatory Arthritis trial of 130 patients followed up for 12 months or more were given. There was a female preponderance; mean age 48.9±13.9 years, rheumatoid factor positivity (86.9%; anti-cyclic citrullinated peptide antibody positivity (89.2%. Seventy patients formed a subgroup of early RA (disease duration ≤6 months (mean 4.17±1.39 months; 60 patients were a subgroup of advanced-stage RA (disease duration >6 months (mean 30.8±32.7 months. In all the patients, therapy was initiated by using subcutaneous MT with its rapid dose escalation up to 20–30 mg/week and the achievement of the treatment goal (low disease activity or remission was checked every 3 months and depending on the result a decision had been taken to add or not to add a biological agent (BA (a tumor necrosis factor inhibitor or abatacept. If the former was insufficiently effective, it was substituted for a BA from another class. Results. Subcutaneous MT monotherapy provided remission or low disease activity in 49 (37.7% patients; a BA was given to 81 (62.3% patients. Following 6 and 12 months, low activity or remission according

  2. Digital health promotion in sexual health clinics: results of a feasibility trial of the Men’s Safer Sex website

    Directory of Open Access Journals (Sweden)

    Julia V Bailey

    2015-10-01

    The best way to assess the impact of the MenSS website was by recording STI diagnoses from clinical records. Response rates for the online questionnaire were poor despite offers of incentives. There were many challenges to conducting an online trial of a sexual health website including ethical committee concerns about email content, poor reliability of trial-related software, balancing data protection and security protocols against ease of access for participants, barriers to patient access to IT in NHS clinics, and trying to ensure that participants engage with a digital intervention for long enough. Whilst digital interventions have great potential for health promotion, we encountered significant obstacles to online research, and to implementation of an IDI in an NHS clinical setting.

  3. THE COST-EFFECTIVENESS OF COGNITIVE BEHAVIOR THERAPY FOR BORDERLINE PERSONALITY DISORDER: RESULTS FROM THE BOSCOT TRIAL

    OpenAIRE

    Palmer, Stephen; Davidson, Kate; Tyrer, Peter; Gumley, Andrew; Tata, Philip; Norrie, John; Murray, Heather; Seivewright, Helen

    2006-01-01

    Borderline personality disorder places a significant burden on healthcare providers and other agencies. This study evaluated the cost-effectiveness of cognitive behavior therapy plus treatment as usual compared to treatment as usual alone for patients with borderline personality disorder. The economic analysis was conducted alongside a multi-center, randomized controlled trial. The costs of primary and secondary healthcare utilization, alongside the wider economic costs, were estimated from m...

  4. Desarda Versus Lichtenstein Technique for Primary Inguinal Hernia Treatment: 3-Year Results of a Randomized Clinical Trial

    OpenAIRE

    Szopinski, Jacek; Dabrowiecki, Stanislaw; Pierscinski, Stanislaw; Jackowski, Marek; Jaworski, Maciej; Szuflet, Zbigniew

    2012-01-01

    Background The Shouldice method and other tissue-based techniques are still acknowledged to be acceptable for primary inguinal hernia repair according to the European Hernia Society guidelines. Desarda’s technique, presented in 2001, is an original hernia repair method using an undetached strip of external oblique aponeurosis. This randomized trial compared outcomes after hernia repair with Desarda (D) and mesh-based Lichtenstein (L) techniques. Methods A total of 208 male patients were rando...

  5. Barriers to and facilitators of implementing complex workplace dietary interventions: process evaluation results of a cluster controlled trial

    OpenAIRE

    Fitzgerald, Sarah; Geaney, Fiona; Kelly, Clare; McHugh, Sheena; Perry, Ivan J

    2016-01-01

    Background Ambiguity exists regarding the effectiveness of workplace dietary interventions. Rigorous process evaluation is vital to understand this uncertainty. This study was conducted as part of the Food Choice at Work trial which assessed the comparative effectiveness of a workplace environmental dietary modification intervention and an educational intervention both alone and in combination versus a control workplace. Effectiveness was assessed in terms of employees’ dietary intakes, nutri...

  6. 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-adva...... is essential for the effect. MNA has no placebo effect. MAA may be a good alternative to CPAP in subsets of OSA patients Udgivelsesdato: 2008/6...

  7. Pharmacist-led management of chronic pain in primary care:results from a randomised controlled exploratory trial

    OpenAIRE

    Bruhn, Hanne; Christine M. Bond; Elliott, Alison M; Hannaford, Philip C; Amanda J Lee; McNamee, Paul; Smith, Blair H; Watson, Margaret C; Holland, Richard; Wright, David

    2013-01-01

    Objectives To compare the effectiveness of pharmacist medication review, with or without pharmacist prescribing, with standard care, for patients with chronic pain. Design An exploratory randomised controlled trial. Setting Six general practices with prescribing pharmacists in Grampian (3) and East Anglia (3). Participants Patients on repeat prescribed pain medication (4815) were screened by general practitioners (GPs), and mailed invitations (1397). 196 were randomised and 180 (92%) complete...

  8. A low-cost repellent for malaria vectors in the Americas: results of two field trials in Guatemala and Peru

    OpenAIRE

    Sihuincha Moisés; Darling Samuel T; Moore Sarah J; Padilla Norma; Devine Gregor J

    2007-01-01

    Abstract Background The cost of mosquito repellents in Latin America has discouraged their wider use among the poor. To address this problem, a low-cost repellent was developed that reduces the level of expensive repellent actives by combining them with inexpensive fixatives that appear to slow repellent evaporation. The chosen actives were a mixture of para-menthane-diol (PMD) and lemongrass oil (LG). Methods To test the efficacy of the repellent, field trials were staged in Guatemala and Pe...

  9. Oral azithromycin in extended dosage schedule for chronic, subclinical Chlamydia pneumoniae infection causing coronary artery disease: a probable cure in sight? Results of a controlled preliminary trial

    Directory of Open Access Journals (Sweden)

    Dogra J

    2012-06-01

    Full Text Available Jaideep DograPoly Clinic, Central Government Health Scheme, Jaipur, Rajasthan, IndiaPurpose: Two mega trials have raised the question as to whether the hypothesis that infection plays a role in atherosclerosis is still relevant. This controlled preliminary trial investigated an extended dose of azithromycin in the treatment of Chlamydia pneumoniae infection causing coronary artery disease (CAD.Patients and methods: Forty patients with documentary evidence of CAD were screened for immunoglobulin G titers against C. pneumoniae and grouped into either the study group (patients with positive titer, n = 32 or control group (patients with negative titer, n = 8. Cases who met inclusion criteria could not have had coronary artery bypass graft surgery or percutaneous coronary intervention in the preceding 6 months. Informed consent was obtained from every patient. Baseline blood samples were analyzed for red blood cell indices, serum creatinine, and liver function tests, and repeated every 2 months. A primary event was defined as the first occurrence of death by any cause, recurrent myocardial infarction, coronary revascularization procedure, or hospitalization for angina. Patients in the study group received 500 mg of oral azithromycin once daily for 5 days, which was then repeated after a gap of 10 days (total of 24 courses in the 1-year trial period. The control group did not have azithromycin added to their standard CAD treatment.Results: In the study group, 30 patients completed the trial. Two patients had to undergo percutaneous coronary intervention in the initial first quarter of the 1-year trial period. In the control group, one patient died during the trial, one had to undergo coronary artery bypass graft surgery, and one had percutaneous coronary intervention.Conclusion: The patients tolerated the therapy well and there was a positive correlation between azithromycin and secondary prevention of CAD.Keywords: azithromycin, Chlamydia pneumoniae

  10. Oral pilocarpine for radiation-induced xerostomia: integrated efficacy and safety results from two prospective randomized clinical trials

    International Nuclear Information System (INIS)

    Purpose: Pilocarpine hydrochloride administered in either a fixed-dose or in a dose-titration protocol three times a day for 12 weeks was evaluated for its ability to relieve symptoms of postradiation xerostomia and to improve saliva production. The studies were randomized, double-blind, placebo-controlled, multicenter clinical trials. A total of 369 patients who had received at least 40 Gy of radiation to the head and neck with clinically significant xerostomia were enrolled in the two studies. In the dose-titration study, 162 patients were enrolled and they received a thrice daily regimen of 2.5 mg tablets for first 4 weeks, 5.0 mg tablets for the second 4 weeks, and 10.0 mg tablets for last 4 weeks of a 12-week study. Patients in the titration study were allowed to down titrate following at least one dose escalation to alleviate bothersome side effects, if any. In the fixed dose study, 207 patients received either placebo, 5.0 mg, or 10.0 mg tablets t.i.d. for 12 weeks. Methods and Materials: Patients were evaluated for symptomatic relief by responding to questionnaires using visual analog scales and categorical questions; and, for saliva production by sialometry. Questionnaires measured relief of intraoral dryness, improvement in overall condition (global response), oral discomfort, difficulty in speaking, chewing and swallowing, denture wearing, and usage of artificial saliva. Evaluations were conducted at baseline, and weeks 4, 8, and 12. Results: There were statistically significant improvements in salivary flow in pilocarpine treatment groups vs. placebo. There was a significant improvement in the overall 'global' condition of xerostomia associated with the use of pilocarpine in both studies. In the fixed-dose study, there were significant improvements in oral dryness, mouth comfort, ability to speak, and reduction in the use of oral comfort agents. The dose-titration study showed improvements in dryness that approached significance (p = 0.057) and a

  11. Mass treatment with azithromycin for trachoma: when is one round enough? Results from the PRET Trial in the Gambia.

    Directory of Open Access Journals (Sweden)

    Emma M Harding-Esch

    Full Text Available BACKGROUND: The World Health Organization has recommended three rounds of mass drug administration (MDA with antibiotics in districts where the prevalence of follicular trachoma (TF is ≥10% in children aged 1-9 years, with treatment coverage of at least 80%. For districts at 5-10% TF prevalence it was recommended that TF be assessed in 1-9 year olds in each community within the district, with three rounds of MDA provided to any community where TF≥10%. Worldwide, over 40 million people live in districts whose TF prevalence is estimated to be between 5 and 10%. The best way to treat these districts, and the optimum role of testing for infection in deciding whether to initiate or discontinue MDA, are unknown. METHODS: In a community randomized trial with a factorial design, we randomly assigned 48 communities in four Gambian districts, in which the prevalence of trachoma was known or suspected to be above 10%, to receive annual mass treatment with expected coverage of 80-89% ("Standard", or to receive an additional visit in an attempt to achieve coverage of 90% or more ("Enhanced". The same 48 communities were randomised to receive mass treatment annually for three years ("3×", or to have treatment discontinued if Chlamydia trachomatis (Ct infection was not detected in a sample of children in the community after mass treatment (stopping rule("SR". Primary outcomes were the prevalence of TF and of Ct infection in 0-5 year olds at 36 months. RESULTS: The baseline prevalence of TF and of Ct infection in the target communities was 6.5% and 0.8% respectively. At 36 months the prevalence of TF was 2.8%, and that of Ct infection was 0.5%. No differences were found between the arms in TF or Ct infection prevalence either at baseline (Standard-3×: TF 5.6%, Ct 0.7%; Standard-SR: TF 6.1%, Ct 0.2%; Enhanced-3×: TF 7.4%, Ct 0.9%; and Enhanced-SR: TF 6.2%, Ct 1.2%; or at 36 months (Standard-3×: TF 2.3%, Ct 1.0%; Standard-SR TF 2.5%, Ct 0.2%; Enhanced-3

  12. Radiotherapy plus nimotuzumab or placebo in the treatment of high grade glioma patients: results from a randomized, double blind trial

    International Nuclear Information System (INIS)

    The prognosis of patients bearing high grade glioma remains dismal. Epidermal Growth Factor Receptor (EGFR) is well validated as a primary contributor of glioma initiation and progression. Nimotuzumab is a humanized monoclonal antibody that recognizes the EGFR extracellular domain and reaches Central Nervous System tumors, in nonclinical and clinical setting. While it has similar activity when compared to other anti-EGFR antibodies, it does not induce skin toxicity or hypomagnesemia. A randomized, double blind, multicentric clinical trial was conducted in high grade glioma patients (41 anaplastic astrocytoma and 29 glioblastoma multiforme) that received radiotherapy plus nimotuzumab or placebo. Treatment and placebo groups were well-balanced for the most important prognostic variables. Patients received 6 weekly doses of 200 mg nimotuzumab or placebo together with irradiation as induction therapy. Maintenance treatment was given for 1 year with subsequent doses administered every 3 weeks. The objectives of this study were to assess the comparative overall survival, progression free survival, response rate, immunogenicity and safety. The median cumulative dose was 3200 mg of nimotuzumab given over a median number of 16 doses. The combination of nimotuzumab and RT was well-tolerated. The most prevalent related adverse reactions included nausea, fever, tremors, anorexia and hepatic test alteration. No anti-idiotypic response was detected, confirming the antibody low immunogenicity. The mean and median survival time for subjects treated with nimotuzumab was 31.06 and 17.76 vs. 21.07 and 12.63 months for the control group. In this randomized trial, nimotuzumab showed an excellent safety profile and significant survival benefit in combination with irradiation. Cuban National Register for clinical trials (No. 1745) (http://registroclinico.sld.cu/ensayos)

  13. Placebo response in antipsychotic trials of patients with acute mania: Results of an individual patient data meta-analysis.

    Science.gov (United States)

    Welten, C C M; Koeter, M W J; Wohlfarth, T; Storosum, J G; van den Brink, W; Gispen-de Wied, C C; Leufkens, H G M; Denys, D A J P

    2015-07-01

    We examined the role of placebo response in acute mania trials. Specifically, whether placebo response: (1) predicts treatment effect, (2) can be predicted by patient and study characteristics, and (3) can be predicted by a parsimonious model. We performed a meta-analysis of individual patient data from 10 registration studies (n=1019) for the indication acute manic episode of bipolar disorder. We assessed the effect of 14 determinants on placebo response. Primary outcome measures were mean symptom change score (MCS) on the Young Mania Rating Scale (YMRS) and response rate (RR), defined as ≥ 50% YMRS symptom improvement from baseline to endpoint. The overall placebo response was 8.5 points improvement on the YMRS (=27.9%) with a RR of 32.8%. Placebo response was significantly associated with the overall treatment response. Five determinants significantly (p<0.05) predicted the placebo response. The multivariate prediction model, which consisted of baseline severity, psychotic features at baseline, number of geographic regions, and region, explained 10.4% and 5.5% of the variance in MSC and RR, respectively. Our findings showed that the placebo response in efficacy trials of antipsychotics for acute mania is substantial and an important determinant of treatment effect. Placebo response is influenced by patient characteristics (illness severity and presence of psychotic features) and by study characteristics (study year, number of geographic regions and region). However, the prediction model could only explain the placebo response to a limited extent. Therefore, limiting trials to certain patients in certain geographic regions seems not a viable strategy to improve assay sensitivity. PMID:25907248

  14. The Influence of Tai Chi Exercise on Proprioception in Patients with Knee Osteoarthritis: Results from a Pilot Randomized Controlled Trial

    OpenAIRE

    Schmid, Anna; McAlindon, Timothy; Schmid, Christopher H.; Wang, Chenchen

    2013-01-01

    Purpose: Previous long-term observational studies found that Tai Chi practitioners had better knee- joint proprioceptive acuity versus controls in an older population. We evaluated the effects of Tai Chi for knee- joint proprioception in knee osteoarthritis (OA) in a randomized controlled trial. Methods: We randomized 40 eligible individuals (age > 55, BMI ≤ 40 kg/m2 with knee pain on most days of the previous month and tibiofemoral OA (K/L grade ≥2) to Tai Chi (10 modified forms from clas...

  15. THE EFFICACY AND SAFETY OF CARMOLIS GEL IN THE COMBINATION THERAPY OF KNEE OSTEOARTHRITIS: RESULTS OF A MULTICENTER CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    I. N. Denisov

    2015-01-01

    Full Text Available Osteoarthritis (OA is one of the most common rheumatic diseases. Knee OA is particularly frequently encountered among all forms of OA, the prevalence of knee OA being about 25% in the general population. Despite multiple guidelines for the management of knee OA, which have been prepared by the European League Against Rheumatism (EULAR, the American College of Rheumatology (ACR, and the Osteoarthritis Research Society International (OARSI, many problems of its treatment policy remain to be solved. The same holds true for not only the symptomatic and disease-modifying effects of chondroprotectors, but also topical therapy options.Objective: to evaluate the clinical efficacy and safety of Carmolis gel in patients with knee OA.Subjects and methods.The trial included 280 patients with knee OA (a study group consisted of 190 patents; a control group comprised 90 patients. The mean age was 58.3±9.3 years in the study group and 59±10.5 years in the control group. The disease duration was 10.3±5.5 and 10.1±4.1 years, respectively. Carmolis gel was applied to the region of the most painful knee joint up to 4–5 times daily, followed by massage of this skin area. The treatment cycle lasted for 2 weeks. No therapy was performed in the control patients. The clinical efficacy was determined by the changes in joint pains at rest or on movement and palpation, according to a visual analogue scale (VAS, WOMAC questionnaire, the synovitis intensity (assessed by ultrasonography, patient and physician global assessments of disease activity (Likert scale, and the possibility of reducing the daily dosage of nonsteroidal anti-inflammatory drugs (NSAIDs. The onset the therapeutic effect of the gel and the duration of its action were recorded.Results and discussion. The topical application of Carmolis gel caused a statistically significant reduction in joint pain at rest and on movement from 57.7±6.8 to 12±1.8 mm (р < 0.01 and from 52±5.3 to 17±2.7 mm

  16. SMALL-DOSE CYTOKINES IN COMBINATION WITH 5-FLUOROURACIL IN OLISSEMINATED RENAL CELL CARCINOMA: FINAL RESULTS OF A RANDOMIZED TRIAL

    Directory of Open Access Journals (Sweden)

    L. V. Demidov

    2009-01-01

    Full Text Available Background: High and intermediate IL-2 regimens are difficult to recommend because of great toxicity and efficacy is not sufficient. We suggest that a combination of very low-dose cytokines is effective and safe in metastatic renal cell carcinoma (MRCC patients (pts. A prospective randomized study was started in 2003. The primary end-point was a response rate. Methods: The eligibility criteria included histopathologically confirmed MRCC, ECOG PS 0-2, no autoimmune diseases, no brain metastases, and normal organ function. All pts were randomized in three arms: IL-2 alone, 1.5 MIU, iv, t.i.w., weeks 1—3 or IL-2 1.0 MIU, iv, t.i.w., weeks 1—3 plus IFN 5 MIU, sc, t.i.w, weeks 1—3 or biochemotherapy group 5-FU, 500 mg/m2, iv, once a week, weeks 1—3 plus IL-2 1.0 MIU, iv, t.i.w., weeks 1—3 plus IFN 5 MIU, sc, t.i.w., weeks 1—3. Courses were repeated every three weeks. A response was assessed according to the RECIST every 2 courses.Results: 64 pts were enrolled, of whom 63 were analyzed. Their median age was 55.4 years (range 16—74. 42.9% of the patients had pre- viously received chemo- or immunotherapy. 55.6 percent of the pts had poor prognosis (according to Motzer et al., 2002. Bone metastases were present in 52.4% of the pts. Sixteen patients treated with IL-2 alone showed no CR, PR, 2 SD, or 14 PD. Of 23 patients in the IL-2+IFN group, there were 5 PR, 8 SD, and 10 PD, with a response rate of 21.7%. Amongst 24 patients in the 5-FU+IL-2+IFN group, there were 1 CR, 3 PR, 10 SD, and 10 PD, with a response rate of 16.7%. One-year survival was 20.0%, 81.3% and 81.0%, respectively. The influenza-like syndrome was the most common side effect in the pts who received IFN (89.1%, grade 1, CTC. Hypotension associated with IL-2 (all groups was seen in 56.3% (50%, grade 1 and 6.3%, grade 2. The other adverse reactions were 12.7% grade 1 neutropenia and vomiting in 4.7% pts (Group 3.Conclusion: All regimens are well tolerated. Small-dose IL-2

  17. Sustainable gasification–biochar systems? A case-study of rice-husk gasification in Cambodia, Part II: Field trial results, carbon abatement, economic assessment and conclusions

    International Nuclear Information System (INIS)

    In part I we described the gasification technology and characterised the physio-chemical properties and environmental impacts of the rice husk char (RHC) by-product. In part II we present summary results from field trials using the RHC, and provide an estimate of the carbon abatement and economic evaluation of the system. Statistically significant yield increases are demonstrated for RHC addition in irrigated rice cultivation (33% increase in paddy rice yield for a 41.5 t (dry weight) RHC application per hectare). The carbon abatement from the RHC addition is approximately 0.42 t CO2 t−1 rice husk; including energy generation from gasification this increases to ca. 0.86 tCO2 t−1. Assuming a carbon value of $5 t CO2 t−1, and agronomic value of $3 t−1 RHC based on the field trials, the economic value of the RHC varies from $9 t−1 (including only recalcitrant carbon) to $15 t−1 (including avoided emissions from energy production). We summarise results from parts I and II, concluding that the gasification–biochar system meets many of the criteria of sustainability, but requires better waste water management and more field trials to demonstrate repeatable agronomic efficacy of RHC application. - Highlights: ► Field trials show statistically significant rice yield increases using rice husk char (RHC). ► Carbon abatement of 0.42 t CO2 t−1 rice husk from RHC production. ► Bioenergy generation via gasification gives carbon abatement of 0.44 t CO2 t−1 husk. ► Total carbon abatement is therefore ca. 0.86 t CO2 t−1 husk. ► Agronomic value from trials is $3 t−1 char; assuming $5 CO2 t−1, the total value of RHC is $9–$15 t−1.

  18. [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. PMID:27220801

  19. [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.

  20. Results availability for analgesic device, complex regional pain syndrome, and post-stroke pain trials: comparing the RReADS, RReACT, and RReMiT databases

    Science.gov (United States)

    Dufka, Faustine L.; Munch, Troels; Dworkin, Robert H.; Rowbotham, Michael C.

    2015-01-01

    Abstract Evidence-based medicine rests on the assumption that treatment recommendations are robust, free from bias, and include results of all randomized clinical trials. The Repository of Registered Analgesic Clinical Trials search and analysis methodology was applied to create databases of complex regional pain syndrome (CRPS) and central post-stroke pain (CPSP) trials and adapted to create the Repository of Registered Analgesic Device Studies databases for trials of spinal cord stimulation (SCS), repetitive transcranial magnetic stimulation (rTMS), and transcranial direct current stimulation (tDCS). We identified 34 CRPS trials, 18 CPSP trials, 72 trials of SCS, and 92 trials of rTMS/tDCS. Irrespective of time since study completion, 45% of eligible CRPS and CPSP trials and 46% of eligible SCS and rTMS/tDCS trials had available results (peer-reviewed literature, results entered on registry, or gray literature); peer-reviewed publications could be found for 38% and 39%, respectively. Examining almost 1000 trials across a spectrum of painful disorders (fibromyalgia, diabetic painful neuropathy, post-herpetic neuralgia, migraine, CRPS, CPSP) and types of treatment, no single study characteristic consistently predicts unavailability of results. Results availability is higher 12 months after study completion but remains below 60% for peer-reviewed publications. Recommendations to increase results availability include supporting organizations advocating for transparency, enforcing existing results reporting regulations, enabling all primary registries to post results, stating trial registration numbers in all publication abstracts, and reducing barriers to publishing “negative” trials. For all diseases and treatment modalities, evidence-based medicine must rigorously adjust for the sheer magnitude of missing results in formulating treatment recommendations. PMID:25599303

  1. Community risk factors for ocular Chlamydia infection in Niger: pre-treatment results from a cluster-randomized trachoma trial.

    Directory of Open Access Journals (Sweden)

    Abdou Amza

    Full Text Available BACKGROUND: Trachoma control programs utilize mass azithromycin distributions to treat ocular Chlamydia trachomatis as part of an effort to eliminate this disease world-wide. But it remains unclear what the community-level risk factors are for infection. METHODS: This cluster-randomized, controlled trial entered 48 randomly selected communities in a 2×2 factorial design evaluating the effect of different treatment frequencies and treatment coverage levels. A pretreatment census and examination established the prevalence of risk factors for clinical trachoma and ocular chlamydia infection including years of education of household head, distance to primary water source, presence of household latrine, and facial cleanliness (ocular discharge, nasal discharge, and presence of facial flies. Univariate and multivariate associations were tested using linear regression and Bayes model averaging. FINDINGS: There were a total of 24,536 participants (4,484 children aged 0-5 years in 6,235 households in the study. Before treatment in May to July 2010, the community-level prevalence of active trachoma (TF or TI utilizing the World Health Organization [WHO] grading system was 26.0% (95% CI: 21.9% to 30.0% and the mean community-level prevalence of chlamydia infection by Amplicor PCR was 20.7% (95% CI: 16.5% to 24.9% in children aged 0-5 years. Univariate analysis showed that nasal discharge (0.29, 95% CI: 0.04 to 0.54; P = 0.03, presence of flies on the face (0.40, 95% CI: 0.17 to 0.64; P = 0.001, and years of formal education completed by the head of household (0.07, 95% CI: 0.07 to 0.13; P = 0.03 were independent risk factors for chlamydia infection. In multivariate analysis, facial flies (0.26, 95% CI: 0.02 to 0.49; P = 0.03 and years of formal education completed by the head of household (0.06, 95% CI: 0.008 to 0.11; P = 0.02 were associated risk factors for ocular chlamydial infection. INTERPRETATION: We have found that the presence

  2. Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind, multicenter, placebo-controlled clinical trials

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    Bharmal Murtuza

    2011-04-01

    Full Text Available Abstract Background Because of the subjective nature of Restless Legs Syndrome (RLS symptoms and the impact of these symptoms on sleep, patient-reported outcomes (PROs play a prominent role as study endpoints in clinical trials investigating RLS treatments. The objective of this study was to validate a new measure, the Post Sleep Questionnaire (PSQ, to assess sleep dysfunction in subjects with moderate-to-severe RLS symptoms. Methods Pooled data were analyzed from two 12-week, randomized, placebo-controlled trials of gabapentin enacarbil (N = 540. At baseline and Week 12, subjects completed the PSQ and other validated health surveys: IRLS Rating Scale, Clinical Global Impression of Improvement (CGI-I, Profile of Mood States (POMS, Medical Outcomes Study Scale-Sleep (MOS-Sleep, and RLS-Quality of Life (RLSQoL. Pooled data were used post hoc to examine the convergent, divergent, known-group validity and the responsiveness of the PSQ. Results Convergent validity was demonstrated by significant correlations between baseline PSQ items and total scores of IRLS, POMS, RLSQoL, and the MOS-Sleep Scale (p ≤ 0.007 each. Divergent validity was demonstrated through the lack of significant correlations between PSQ items and demographic characteristics. Correlations (p Conclusions Although these analyses were potentially limited by the use of clinical trial data and not prospective data from a study conducted solely for validation purposes, the PSQ demonstrated robust psychometric properties and is a valid instrument for assessing sleep and sleep improvements in subjects with moderate-to-severe RLS symptoms. Trial Registration This study analyzed data from two registered trials, NCT00298623 and NCT00365352.

  3. Plasmodium falciparum malaria challenge by the bite of aseptic Anopheles stephensi mosquitoes: results of a randomized infectivity trial.

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    Kirsten E Lyke

    Full Text Available BACKGROUND: Experimental infection of malaria-naïve volunteers by the bite of Plasmodium falciparum-infected mosquitoes is a preferred means to test the protective effect of malaria vaccines and drugs. The standard model relies on the bite of five infected mosquitoes to induce malaria. We examined the efficacy of malaria transmission using mosquitoes raised aseptically in compliance with current Good Manufacturing Practices (cGMPs. METHODS AND FINDINGS: Eighteen adults aged 18-40 years were randomized to receive 1, 3 or 5 bites of Anopheles stephensi mosquitoes infected with the chloroquine-sensitive NF54 strain of P. falciparum. Seventeen participants developed malaria; fourteen occurring on Day 11. The mean prepatent period was 10.9 days (9-12 days. The geometric mean parasitemia was 15.7 parasites/µL (range: 4-70 by microscopy. Polymerase chain reaction (PCR detected parasites 3.1 (range: 0-4 days prior to microscopy. The geometric mean sporozoite load was 16,753 sporozoites per infected mosquito (range: 1,000-57,500. A 1-bite participant withdrew from the study on Day 13 post-challenge and was PCR and smear negative. CONCLUSIONS: The use of aseptic, cGMP-compliant P. falciparum-infected mosquitoes is safe, is associated with a precise prepatent period compared to the standard model and appears more efficient than the standard approach, as it led to infection in 100% (6/6 of volunteers exposed to three mosquito bites and 83% (5/6 of volunteers exposed to one mosquito bite. TRIAL REGISTRATION: ClinicalTrials.gov NCT00744133.

  4. Enhanced Counseling for Women Undergoing BRCA1/2 Testing: Impact on Knowledge and Psychological Distress – Results From a Randomized Clinical Trial

    OpenAIRE

    Roussi, Pagona; Sherman, Kerry Anne; Miller, Suzanne; Buzaglo, Joanne; Daly, Mary; Taylor, Alan; Ross, Eric; Godwin, Andrew

    2010-01-01

    This randomized controlled trial evaluated the impact of an enhanced counseling intervention on knowledge about the heritability of breast and ovarian cancer and distress, as a function of BRCA test result, among high-risk women. Before deciding about whether or not to undergo genetic testing, participants were randomly assigned to the enhanced counseling intervention (N = 69), designed to promote cognitive and affective processing of cancer risk information (following the standard individual...

  5. Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME® trial

    OpenAIRE

    Fitchett, David; Zinman, Bernard; Wanner, Christoph; Lachin, John M.; Hantel, Stefan; Salsali, Afshin; Johansen, Odd Erik; Woerle, Hans J.; Broedl, Uli C.; Inzucchi, Silvio E.

    2016-01-01

    Aims We previously reported that in the EMPA-REG OUTCOME® trial, empagliflozin added to standard of care reduced the risk of 3-point major adverse cardiovascular events, cardiovascular and all-cause death, and hospitalization for heart failure in patients with type 2 diabetes and high cardiovascular risk. We have now further investigated heart failure outcomes in all patients and in subgroups, including patients with or without baseline heart failure. Methods and results Patients were randomi...

  6. Five Year Results of US Intergroup/RTOG 9704 With Postoperative CA 19-9 {<=}90 U/mL and Comparison to the CONKO-001 Trial

    Energy Technology Data Exchange (ETDEWEB)

    Berger, Adam C., E-mail: adam.berger@jefferson.edu [Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Winter, Kathryn [RTOG Statistical Center, Philadelphia, Pennsylvania (United States); Hoffman, John P. [Fox Chase Cancer Center, Philadelphia, Pennsylvania (United States); Regine, William F. [University of Maryland Medical Systems, Baltimore, Maryland (United States); Abrams, Ross A. [Rush University Medical Center, Chicago, Illinois (United States); Safran, Howard [Division of Hematology/Oncology, The Miriam Hospital, Providence, Rhode Island (United States); Freedman, Gary M. [Fox Chase Cancer Center, Philadelphia, Pennsylvania (United States); Benson, Alan B. [Northwestern Memorial Hospital, Chicago, Illinois (United States); MacDonald, John [St. Vincent' s Comprehensive Cancer Center, New York, New York (United States); Willett, Christopher G. [Duke University Medical Center, Durham, North Carolina (United States)

    2012-11-01

    Purpose: Radiation Therapy Oncology Group (RTOG) trial 9704 was the largest randomized trial to use adjuvant chemoradiation therapy for patients with pancreatic cancer. This report analyzes 5-year survival by serum level of tumor marker CA 19-9 of {<=}90 vs >90 U/mL and compares results to the those of the CONKO-001 trial. Methods and Materials: CA 19-9 expression was analyzed as a dichotomized variable ({<=}90 vs >90 U/mL). Cox proportional hazard models were used to identify the impact of the CA 19-9 value on overall survival (OS). Actuarial estimates of OS were calculated using the Kaplan-Meier method. Results: Both univariate (hazard ratio [HR] = 3.2; 95% confidence interval [CI], 2.3-4.3, P<.0001) and multivariate (HR = 3.1; 95% CI, 2.2-4.2, P<.0001) analyses demonstrated a statistically significant decrease in OS for CA 19-9 serum level of {>=}90 U/mL. For patients in the gemcitabine (Gem) treatment arm with CA 19-9 <90 U/mL, median survival was 21 months. For patients with CA 19-9 {>=}90 U/mL, this number dropped to 10 months. In patients with pancreatic head tumors in the Gem treatment arm with RT quality assurance per protocol and CA 19-9 of <90 U/mL, median survival and 5-year rate were 24 months and 34%. In comparison, the median survival and 5-year OS rate for patients in the Gem arm of the CONKO trial were 22 months and 21%. Conclusions: This analysis demonstrates that patients with postresection CA 19-9 values {>=}90 U/mL had a significantly worse survival. Patients with pancreatic head tumors treated with Gem with CA 19-9 serum level of <90 U/mL and per protocol RT had favorable survival compared to that seen in the CONKO trial. CA 19-9 is a stratification factor for the current RTOG adjuvant pancreas trial (0848).

  7. Safety and immunogenicity of an AMA-1 malaria vaccine in Malian adults: results of a phase 1 randomized controlled trial.

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    Mahamadou A Thera

    Full Text Available BACKGROUND: The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria. METHODOLOGY/PRINCIPAL FINDINGS: A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1 based on apical membrane antigen-1 (AMA-1 from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert. Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.5 mL or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Serious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively. CONCLUSION/SIGNIFICANCE: The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults. This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site.

  8. Late Conversion of Kidney Transplant Recipients from Ciclosporin to Tacrolimus Improves Graft Function: Results from a Randomized Controlled Trial.

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    Max Plischke

    Full Text Available Tacrolimus (TAC to ciclosporin A (CSA conversion studies in stable kidney transplant recipients have reported varying effects on graft function. Here we study graft function (eGFR trajectories using linear mixed models, which provide effect estimates on both slope and baseline level of GFR and offer increased statistical power.Secondary analysis of a randomized controlled trial of CSA treated kidney transplant recipients with stable graft function assigned to receive 0.1 mg/kg/day TAC (target 5-8 ng/ml or to continue CSA based immunosuppression (target 70-150 ng/ml at a 2:1 ratio. Renal graft function was estimated via the MDRD (eGFRMDRD and CKD-EPI (eGFRCKD-EPI formulas.Forty-five patients continued CSA and 96 patients were converted to TAC with a median follow up of 24 months. Baseline demographics (except for recipient age including native kidney disease, transplant characteristics, kidney graft function, medication use and comorbid conditions did not differ between groups. In respect to long-term renal graft function, linear mixed models showed significantly improved eGFR trajectories (eGFRMDRD: p<0.001, eGFRCKD-EPI: p<0.001 in the TAC versus CSA group over 24 months of follow up. Estimated eGFRCKD-EPI group differences between TAC and CSA were -3.49 (p = 0.019 at 3 months, -5.50 (p<0.001 at 12 months, and -4.48 ml/min/1.73m2 (p = 0.003 at 24 months of follow up. Baseline eGFR was a significant predictor of eGFR trajectories (eGFRMDRD: p<0.001, eGFRCKD-EPI: p<0.001. Significant effects for randomization group were evident despite short-term trough levels in the supratherapeutic range (27% (n = 26 of TAC patients at week one. Median TAC trough levels were within target range at week 4 after conversion.Conversion of CSA treated kidney transplant recipients with stable graft function to TAC (target 5-8 ng/ml showed significantly improved long-term eGFR trajectories when compared to CSA maintenance (target 70-150 ng/ml.ClinicalTrials.gov NCT

  9. Long-term results of a randomized phase III trial of TPF induction chemotherapy followed by surgery and radiation in locally advanced oral squamous cell carcinoma.

    Science.gov (United States)

    Zhong, Lai-ping; Zhang, Chen-ping; Ren, Guo-xin; Guo, Wei; William, William N; Hong, Christopher S; Sun, Jian; Zhu, Han-guang; Tu, Wen-yong; Li, Jiang; Cai, Yi-li; Yin, Qiu-ming; Wang, Li-zhen; Wang, Zhong-he; Hu, Yong-jie; Ji, Tong; Yang, Wen-jun; Ye, Wei-min; Li, Jun; He, Yue; Wang, Yan-an; Xu, Li-qun; Zhuang, Zhengping; Lee, J Jack; Myers, Jeffrey N; Zhang, Zhi-yuan

    2015-07-30

    Previously, we conducted a randomized phase III trial of TPF (docetaxel, cisplatin, and 5-fluorouracil) induction chemotherapy in surgically managed locally advanced oral squamous cell carcinoma (OSCC) and found no improvement in overall survival. This study reports long-term follow-up results from our initial trial. All patients had clinical stage III or IVA locally advanced OSCC. In the experimental group, patients received two cycles of TPF induction chemotherapy (75mg/m2 docetaxel d1, 75mg/m2 cisplatin d1, and 750mg/m2/day 5-fluorouracil d1-5) followed by radical surgery and post-operative radiotherapy; in the control group, patients received upfront radical surgery and post-operative radiotherapy. The primary endpoint was overall survival. Among 256 enrolled patients with a median follow-up of 70 months, estimated 5-year overall survival, disease-free survival, locoregional recurrence-free survival, and distant metastasis-free survival rates were 61.1%, 52.7%, 55.2%, and 60.4%, respectively. There were no significant differences in survival rates between experimental and control groups. However, patients with favorable pathologic responses had improved outcomes compared to those with unfavorable pathologic responses and to those in the control group. Although TPF induction chemotherapy did not improve long-term survival compared to surgery upfront in patients with stage III and IVA OSCC, a favorable pathologic response after induction chemotherapy may be used as a major endpoint and prognosticator in future studies. Furthermore, the negative results observed in this trial may be represent type II error from an underpowered study. Future larger scale phase III trials are warranted to investigate whether a significant benefit exists for TPF induction chemotherapy in surgically managed OSCC. PMID:26124084

  10. Usability of a novel disposable autoinjector device for ixekizumab: results from a qualitative study and an open-label clinical trial, including patient-reported experience

    Science.gov (United States)

    Callis Duffin, Kristina; Bukhalo, Michael; Bobonich, Margaret A; Shrom, David; Zhao, Fangyi; Kershner, James R; Gill, Anne; Pangallo, Beth; Shuler, Catherine L; Bagel, Jerry

    2016-01-01

    Background Most biologic therapies for psoriasis are delivered via subcutaneous injection. Ixekizumab, an anti-interleukin 17A monoclonal antibody approved for patients with moderate-to-severe plaque psoriasis, is delivered subcutaneously via prefilled syringe or autoinjector. Here we report the results of an ixekizumab autoinjector usability study as well as the patient-reported experience with the autoinjector in a clinical trial. Methods The usability study enrolled 49 subjects (patients with a range of autoimmune conditions or their caregivers). Subjects were randomized to a trained or untrained group and were evaluated for their ability to perform an injection successfully when provided the device and the instructions for use. In the clinical trial, 102 subjects (patients with psoriasis or their caregivers) used the autoinjector to deliver injections of ixekizumab (80 mg every 2 weeks after a starting dose of 160 mg). At weeks 0, 4, and 8, subjects completed the subcutaneous administration assessment questionnaire, which assesses the ease of use and confidence with using an injection device. Results In the usability study, all subjects in the untrained arm performed successful injections, while two subjects in the trained arm had an injection failure. These incidences were not consistent with any pattern of issues with the device or the instructions for use. In the clinical trial, there were two injection failures of 674 total self-injections performed over 12 weeks. At the first use of the device, 95% of subjects either agreed or strongly agreed that the device was “overall easy to use”, and they felt “confident the dose was complete” according to the subcutaneous administration assessment questionnaire. Conclusion The ixekizumab autoinjector was used successfully by patients and caregivers with or without training. Subjects using the autoinjector in a clinical trial felt it was easy to use and felt confident while using it. PMID:27785115

  11. Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications

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    Mahapatra Rajendra

    2011-06-01

    Full Text Available Abstract Background Public health interventions are increasingly evaluated using cluster-randomised trials in which groups rather than individuals are allocated randomly to treatment and control arms. Outcomes for individuals within the same cluster are often more correlated than outcomes for individuals in different clusters. This needs to be taken into account in sample size estimations for planned trials, but most estimates of intracluster correlation for perinatal health outcomes come from hospital-based studies and may therefore not reflect outcomes in the community. In this study we report estimates for perinatal health outcomes from community-based trials to help researchers plan future evaluations. Methods We estimated the intracluster correlation and the coefficient of variation for a range of outcomes using data from five community-based cluster randomised controlled trials in three low-income countries: India, Bangladesh and Malawi. We also performed a simulation exercise to investigate the impact of cluster size and number of clusters on the reliability of estimates of the coefficient of variation for rare outcomes. Results Estimates of intracluster correlation for mortality outcomes were lower than those for process outcomes, with narrower confidence intervals throughout for trials with larger numbers of clusters. Estimates of intracluster correlation for maternal mortality were particularly variable with large confidence intervals. Stratified randomisation had the effect of reducing estimates of intracluster correlation. The simulation exercise showed that estimates of intracluster correlation are much less reliable for rare outcomes such as maternal mortality. The size of the cluster had a greater impact than the number of clusters on the reliability of estimates for rare outcomes. Conclusions The breadth of intracluster correlation estimates reported here in terms of outcomes and contexts will help researchers plan future

  12. Conflicting results of robot-assisted versus usual gait training during postacute rehabilitation of stroke patients: a randomized clinical trial.

    Science.gov (United States)

    Taveggia, Giovanni; Borboni, Alberto; Mulé, Chiara; Villafañe, Jorge H; Negrini, Stefano

    2016-03-01

    Robot gait training has the potential to increase the effectiveness of walking therapy. Clinical outcomes after robotic training are often not superior to conventional therapy. We evaluated the effectiveness of a robot training compared with a usual gait training physiotherapy during a standardized rehabilitation protocol in inpatient participants with poststroke hemiparesis. This was a randomized double-blind clinical trial in a postacute physical and rehabilitation medicine hospital. Twenty-eight patients, 39.3% women (72±6 years), with hemiparesis (Bobath approach were assigned randomly to an experimental or a control intervention of robot gait training to improve walking (five sessions a week for 5 weeks). Outcome measures included the 6-min walk test, the 10 m walk test, Functional Independence Measure, SF-36 physical functioning and the Tinetti scale. Outcomes were collected at baseline, immediately following the intervention period and 3 months following the end of the intervention. The experimental group showed a significant increase in functional independence and gait speed (10 m walk test) at the end of the treatment and follow-up, higher than the minimal detectable change. The control group showed a significant increase in the gait endurance (6-min walk test) at the follow-up, higher than the minimal detectable change. Both treatments were effective in the improvement of gait performances, although the statistical analysis of functional independence showed a significant improvement in the experimental group, indicating possible advantages during generic activities of daily living compared with overground treatment. PMID:26512928

  13. Evaluation of Oral Robenacoxib for the Treatment of Postoperative Pain and Inflammation in Cats: Results of a Randomized Clinical Trial

    Science.gov (United States)

    King, Stephen; Roberts, Elizabeth S.; Roycroft, Linda M.; King, Jonathan N.

    2012-01-01

    The efficacy and safety of robenacoxib were assessed for the control of postoperative pain and inflammation in cats. The study was a multicenter, prospective, randomized, blinded, and parallel group clinical trial. A total of 249 client-owned cats scheduled for forelimb onychectomy plus either ovariohysterectomy or castration surgeries were included. All cats received butorphanol prior to anesthesia and forelimb four-point regional nerve blocks with bupivacaine after induction of general anesthesia. Cats were randomized to receive daily oral tablet robenacoxib, at a mean (range) dosage of 1.84 (1.03–2.40) mg/kg (n = 167), or placebo (n = 82), once prior to surgery and for two days postoperatively. Significantly (P < 0.05) fewer robenacoxib cats received additional analgesia rescue therapy (16.5%) than placebo cats (46.3%). Pain elicited on palpation of the soft tissue incision site, behavior following social interaction, and posture assessed during the first 8 hours after extubation were significantly (P < 0.05) improved in cats receiving robenacoxib. Frequency of reported adverse clinical signs, hematology, serum chemistry and urinalysis variables, and body weight changes weresimilar between groups. In conclusion, robenacoxib was effective and well tolerated in the control of postoperative pain and inflammation in cats undergoing onychectomy with ovariohysterectomy or castration. PMID:23738129

  14. Effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement and mental health: results of a randomized controlled trial.

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    Jantien van Berkel

    Full Text Available OBJECTIVES: The aim of the present study was to evaluate the effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness. METHODS: In a randomized controlled trial design, 257 workers of two research institutes participated. The intervention group (n = 129 received a targeted mindfulness-related training, followed by e-coaching. The total duration of the intervention was 6 months. Data on work engagement, mental health, need for recovery and mindfulness were collected using questionnaires at baseline and after 6 and 12 months follow-up. Effects were analyzed using linear mixed effect models. RESULTS: There were no significant differences in work engagement, mental health, need for recovery and mindfulness between the intervention and control group after either 6- or 12-months follow-up. Additional analyses in mindfulness-related training compliance subgroups (high and low compliance versus the control group as a reference and subgroups based on baseline work engagement scores showed no significant differences either. CONCLUSIONS: This study did not show an effect of this worksite mindfulness-related multi-component health promotion intervention on work engagement, mental health, need for recovery and mindfulness after 6 and 12 months. TRIAL REGISTRATION: Netherlands Trial Register NTR2199.

  15. Differential changes in serum uric acid concentrations in sibutramine promoted weight loss in diabetes: results from four weeks of the lead-in period of the SCOUT trial

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    Caterson Ian D

    2009-10-01

    Full Text Available Abstract Background and aims Elevated levels of serum uric acid are associated with an increased risk of cardiovascular morbidity and mortality. The response of uric acid to weight loss therapy (lifestyle plus sibutramine in an overweight and obese cardiovascular high risk population was studied. Methods and results Data from a four week single-blind lead-in period of the Sibutramine Cardiovascular OUTcomes (SCOUT study were analyzed. 2584 patients (24% had diabetes mellitus (DM only, 1748 (16% had cardiovascular disease (CVD only and 6397 (60% had both DM + CVD. Uric acid concentrations (mean ± standard deviation at screening were significantly higher among patients with CVD compared to patients without CVD (p Conclusion A four week daily intake of sibutramine and life style changes was associated with significant reductions in mean uric acid levels. Changes in renal glucose load in diabetes seem to counteract a potential uricosuric effect of sibutramine. Trial Registration The trial is registered at ClinicalTrial.gov number: NCT00234832.

  16. Does the effect of weight lifting on lymphedema following breast cancer differ by diagnostic method: results from a randomized controlled trial.

    Science.gov (United States)

    Hayes, Sandra C; Speck, Rebecca M; Reimet, Elizabeth; Stark, Azadeh; Schmitz, Kathryn H

    2011-11-01

    The lymphedema diagnostic method used in descriptive or intervention studies may influence results found. The purposes of this work were to compare baseline lymphedema prevalence in the physical activity and lymphedema (PAL) trial cohort and to subsequently compare the effect of the weight-lifting intervention on lymphedema, according to four standard diagnostic methods. The PAL trial was a randomized controlled intervention study, involving 295 women who had previously been treated for breast cancer, and evaluated the effect of 12 months of weight lifting on lymphedema status. Four diagnostic methods were used to evaluate lymphedema outcomes: (i) interlimb volume difference through water displacement, (ii) interlimb size difference through sum of arm circumferences, (iii) interlimb impedance ratio using bioimpedance spectroscopy, and (iv) a validated self-report survey. Of the 295 women who participated in the PAL trial, between 22 and 52% were considered to have lymphedema at baseline according to the four diagnostic criteria used. No between-group differences were noted in the proportion of women who had a change in interlimb volume, interlimb size, interlimb ratio, or survey score of ≥5, ≥5, ≥10%, and 1 unit, respectively (cumulative incidence ratio at study end for each measure ranged between 0.6 and 0.8, with confidence intervals spanning 1.0). The variation in proportions of women within the PAL trial considered to have lymphoedema at baseline highlights the potential impact of the diagnostic criteria on population surveillance regarding prevalence of this common morbidity of treatment. Importantly though, progressive weight lifting was shown to be safe for women following breast cancer, even for those at risk or with lymphedema, irrespective of the diagnostic criteria used. PMID:21562712

  17. Topical Treatment With an Agent Disruptive to P. acnes Biofilm Provides Positive Therapeutic Response: Results of a Randomized Clinical Trial.

    Science.gov (United States)

    Bernhardt, Michael J; Myntti, Matthew F

    2016-06-01

    The traditional disease model of acne has been one of follicular plugging due to 'sticky epithelial cells' associated with increased sebum production with deep follicular anaerobic conditions favoring P. acnes- generated inflammation. P. acnes biofilms have been found more frequently in patients with acne than controls. Biofilms are genetically coded to create adhesion to the pilosebaceous unit followed by production of a mucopolysaccharide coating capable of binding to lipid surfaces. Traditional therapies for acne have involved mixtures of oral and topical antibiotics admixed with topical keratolytics and retinoids, which are aimed at traditional bacterial reduction as well as downregulating the inflammatory cascade. These approaches are limited by side effect and compliance/tolerability issues. As the P. acnes biofilm may, in fact, be the instigator of this process, we studied the use of a topical agent designed to reduce the P. acnes biofilm to see if reducing the biofilm would be therapeutically efficacious. We present data of a proprietary topical non-prescription agent with a novel pharmaco mechanism designed to attack the biofilm produced by P. acnes. Our data shows a decrease of inflammatory lesions by 44% and non-inflammatory lesions by 32% after 12 weeks and also provided for a meaningful improvement in the quality of life of the patients in the study. These improvements were achieved with a product that was not associated with burning, chafing, irritation, or erythema, which can be seen with topical treatments. It is apparent from this study that by addressing the biofilm which protects the P. acnes bacteria through the use of the Acne Gel, the incidence of acne symptoms can be greatly reduced, while having no negative impacts on the patients' skin (ClinicalTrials.gov registry number NCT02404285). J Drugs Dermatol. 2016;15(6):677-683. PMID:27272073

  18. Treatment of adults with community-acquired respiratory tract infections: results of a multicentric clinical trial with gatifloxacin

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    Medeiros Eduardo Alexandrino Servolo

    2002-01-01

    Full Text Available Respiratory tract infections have an important clinical and economic impact and they are the most common indication for antibiotic use in outpatient practice. This prospective, multicenter non-controlled trial assessed the efficacy and safety of gatifloxacin in the treatment of community-acquired respiratory tract infections. Patients were treated with a daily oral dose of gatifloxacin 400 mg for 7-14 days. The diagnosis of respiratory infection was made based on the clinical condition and/or radiologic findings. A total of 5,044 adult patients with community-acquired respiratory infections was treated with gatifloxacin in different centers in Brazil between March 1, 2001, and October 31, 2001. Among the 5,044 patients treated, 1,501 patients (29.76% had community-acquired pneumonia, 756 (14.99% had acute exacerbation of chronic bronchitis and 2,787 (55.25% had acute sinusitis. Of the total of patients treated, 3,607 (71.51% were considered cured, 1,261 (25% progressed with some clinical improvement, 28 (0.56% presented a relapse, 56 (1.11% failed to treatment and 92 (1.82% were unable to be evaluated. Adverse events were described in 634 (12.57% patients. The most common adverse events were: nausea (2.24%; dyspepsia (1.86%; diarrhea (0.79%; change in taste (0.46%; insomnia and irritability (0.22%; dizziness (0.77%; headache (0.42%; allergic reaction (0.18%; Central Nervous System alterations - insomnia, agitation, anxiety - (0.46%. This study showed that the treatment of respiratory tract infections with gatifloxacin was safe and efficient and had a low incidence of adverse events.

  19. Shared decision making for prostate cancer screening: the results of a combined analysis of two practice-based randomized controlled trials

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    Sheridan Stacey L

    2012-11-01

    Full Text Available Abstract Background Professional societies recommend shared decision making (SDM for prostate cancer screening, however, most efforts have promoted informed rather than shared decision making. The objective of this study is to 1 examine the effects of a prostate cancer screening intervention to promote SDM and 2 determine whether framing prostate information in the context of other clearly beneficial men’s health services affects decisions. Methods We conducted two separate randomized controlled trials of the same prostate cancer intervention (with or without additional information on more clearly beneficial men’s health services. For each trial, we enrolled a convenience sample of 2 internal medicine practices, and their interested physicians and male patients with no prior history of prostate cancer (for a total of 4 practices, 28 physicians, and 128 men across trials. Within each practice site, we randomized men to either 1 a video-based decision aid and researcher-led coaching session or 2 a highway safety video. Physicians at each site received a 1-hour educational session on prostate cancer and SDM. To assess intervention effects, we measured key components of SDM, intent to be screened, and actual screening. After finding that results did not vary by trial, we combined data across sites, adjusting for the random effects of both practice and physician. Results Compared to an attention control, our prostate cancer screening intervention increased men’s perceptions that screening is a decision (absolute difference +41%; 95% CI 25 to 57% and men’s knowledge about prostate cancer screening (absolute difference +34%; 95% CI 19% to 50%, but had no effect on men’s self-reported participation in shared decisions or their participation at their preferred level. Overall, the intervention decreased screening intent (absolute difference −34%; 95% CI −50% to −18% and actual screening rates (absolute difference −22%; 95% CI −38 to

  20. Granulocyte Colony Stimulating Factor and Physiotherapy after Stroke: Results of a Feasibility Randomised Controlled Trial: Stem Cell Trial of Recovery EnhanceMent after Stroke-3 (STEMS-3 ISRCTN16714730)

    Science.gov (United States)

    Sprigg, Nikola; O’Connor, Rebecca; Woodhouse, Lisa; Krishnan, Kailash; England, Timothy J.; Connell, Louise A.; Walker, Marion F.; Bath, Philip M.

    2016-01-01

    Background Granulocyte-colony stimulating factor (G-CSF) mobilises endogenous haematopoietic stem cells and enhances recovery in experimental stroke. Recovery may also be dependent on an enriched environment and physical activity. G-CSF may have the potential to enhance recovery when used in combination with physiotherapy, in patients with disability late after stroke. Methods A pilot 2 x 2 factorial randomised (1:1) placebo-controlled trial of G-CSF (double-blind), and/or a 6 week course of physiotherapy, in 60 participants with disability (mRS >1), at least 3 months after stroke. Primary outcome was feasibility, acceptability and tolerability. Secondary outcomes included death, dependency, motor function and quality of life measured 90 and 365 days after enrolment. Results Recruitment to the trial was feasible and acceptable; of 118 screened patients, 92 were eligible and 32 declined to participate. 60 patients were recruited between November 2011 and July 2013. All participants received some allocated treatment. Although 29 out of 30 participants received all 5 G-CSF/placebo injections, only 7 of 30 participants received all 18 therapy sessions. G-CSF was well tolerated but associated with a tendency to more adverse events than placebo (16 vs 10 patients, p = 0.12) and serious adverse events (SAE) (9 vs 3, p = 0.10). On average, patients received 14 (out of 18 planned) therapy sessions, interquartile range [12, 17]. Only a minority (23%) of participants completed all physiotherapy sessions, a large proportion of sessions (114 of 540, 21%) were cancelled due to patient (94, 17%) and therapist factors (20, 4%). No significant differences in functional outcomes were detected in either the G-CSF or physiotherapy group at day 90 or 365. Conclusions Delivery of G-CSF is feasible in chronic stroke. However, the study failed to demonstrate feasibility for delivering additional physiotherapy sessions late after stroke therefore a definitive study using this trial design

  1. Slow cortical potential Neurofeedback and self-management training in outpatient care for children with ADHD: study protocol and first preliminary results of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hanna eChristiansen

    2014-11-01

    Full Text Available Background: Treatment for children with attention deficit/hyperactivity disorder (ADHD today is predominantly pharmacological. While it is the most common treatment, it might not always be the most appropriate one. Moreover, long term effects remain unclear. Behavior therapy and non-pharmacological treatments such as neurofeedback (NF are promising alternatives, though there are no routine outpatient care/effectiveness studies yet that have included children with medication or changes in medication.Methods/design: This paper presents the protocol of a randomized controlled trial to compare the effectiveness of a Slow Cortical Potential (SCP NF protocol with self-management (SM in a high frequent outpatient care setting. Both groups (NF/SM receive a total of 30 high frequent therapy sessions. Additionally, 6 sessions are reserved for comorbid problems. The primary outcome measure is the reduction of ADHD core symptoms according to parent and teacher ratings.Preliminary Results: Untill now 58 children were included in the study (48 males, with a mean age of 8.42 (1.34 years, and a mean IQ of 110 (13.37. Conners-3 parent and teacher ratings were used to estimate core symptom change. Since the study is still ongoing, and children are in different study stages, pre-post and follow-up results are not yet available for all children included. Preliminary results suggest overall good pre-post effects, though. For parent and teacher ratings an ANOVA with repeated measures yielded overall satisfying pre-post effects (η2 .175 to .513. Differences between groups (NF vs. SM could not yet be established (p = .81.Discussion: This is the first randomized controlled trial to test the effectiveness of a NF protocol in a high frequent outpatient care setting that does not exclude children on or with changes in medication. First preliminary results show positive effects. The rationale for the trial, the design, and the strengths and limitations of the study are

  2. Long-term side effects of radiotherapy for pediatric localized neuroblastoma. Results from clinical trials NB90 and NB94

    Energy Technology Data Exchange (ETDEWEB)

    Ducassou, Anne [Institut Claudius Regaud, Departement de Radiotherapie, Toulouse (France); Gambart, Marion; Munzer, Caroline; Rubie, Herve [Hopital des Enfants, Departement d' Onco-Hematologie Pediatrique, Toulouse (France); Padovani, Laetitia [Centre Hospitalier et Universitaire, Departement de Radiotherapie, Marseille (France); Carrie, Christian; Claude, Line [Centre Leon Berard, IHOP, Departement de Radiotherapie, Lyon (France); Haas-Kogan, Daphne [University of California, Department of Radiation Oncology, San Francisco (United States); Bernier-Chastagner, Valerie [Centre Alexis Vautrin, Departement de Radiotherapie, Nancy (France); Demoor, Charlotte [Centre Rene Gauducheau, Departement de Radiotherapie, Nantes (France); Helfre, Sylvie [Institut Curie, Departement de Radiotherapie, Paris (France); Bolle, Stephanie [Institut Gustave Roussy, Departement de Radiotherapie, Villejuif (France); Leseur, Julie [Centre Eugene Marquis, Departement de Radiotherapie, Rennes (France); Huchet, Aymeri [Centre Hospitalier et Universitaire, Departement de Radiotherapie, Bordeaux (France); Valteau-Couanet, Dominique [Institut Gustave Roussy, Departement d' Onco-Hematologie Pediatrique, Villejuif (France); Schleiermacher, Gudrun [Institut Curie, Departement d' Onco-Hematologie Pediatrique, Paris (France); Coze, Carole [Aix-Marseille Univ et APHM, Hopital d' Enfants de la Timone, Departement d' hemato-Oncologie Pediatrique, Marseille (France); Defachelles, Anne-Sophie [Centre Oscar Lambret, Departement d' Onco-Hematologie Pediatrique, Lille (France); Marabelle, Aurelien [IHOP, Departement d' Onco-Hematologie Pediatrique, Lyon (France); Ducassou, Stephane [Hopital des Enfants, Departement d' Onco-Hematologie Pediatrique, Bordeaux (France); Devalck, Christine [Hopital des enfants Reine Fabiola, Departement d' Onco-hematologie Pediatrique, Bruxelles (Belgium); Gandemer, Virginie [Centre hospitalier, Departement d' Onco-Hematologie Pediatrique, Rennes (France); Munzer, Martine [Centre hospitalier, Departement d' Onco-hematologie Pediatrique, Reims (France); Laprie, Anne [Institut Claudius Regaud, Departement de Radiotherapie, Toulouse (France); Universite Toulouse III Paul Sabatier, Toulouse (France); INSERM, Toulouse (France); Collaboration: Neuroblastoma study group and radiotherapy group of the French Society of Children with Cancer (SFCE)

    2015-07-15

    Neuroblastoma (NB) is the most frequent indication for extracranial pediatric radiotherapy. As long-term survival of high-risk localized NB has greatly improved, we reviewed treatment-related late toxicities in pediatric patients who received postoperative radiotherapy (RT) for localized NB within two French prospective clinical trials: NB90 and NB94. From 1990-2000, 610 children were enrolled. Among these, 35 were treated with induction chemotherapy, surgery, and RT. The recommended RT dose was 24 Gy at ≤ 2 years, 34 Gy at > 2 years, ± a 5 Gy boost in both age groups. The 22 patients still alive after 5 years were analyzed. The median follow-up time was 14 years (range 5-21 years). Late effects after therapy occurred in 73 % of patients (16/22), within the RT field for 50 % (11/22). The most frequent in-field effects were musculoskeletal abnormalities (n = 7) that occurred only with doses > 31 Gy/1.5 Gy fraction (p = 0.037). Other effects were endocrine in 3 patients and second malignancies in 2 patients. Four patients presented with multiple in-field late effects only with doses > 31 Gy. After a median follow-up of 14 years, late effects with multimodality treatment were frequent. The most frequent effects were musculoskeletal abnormalities and the threshold for their occurrence was 31 Gy. (orig.) [German] Das Neuroblastom (NB) ist die haeufigste Indikation fuer eine extrakranielle paediatrische Strahlentherapie. Da sich beim lokalisierten Hochrisiko-NB das langfristige Ueberleben stark verbessert hat, ueberprueften wir die behandlungsbedingte spaete Toxizitaet bei paediatrischen Patienten, die im Rahmen zweier prospektiver klinischer Studien in Frankreich (NB90 und NB94) eine postoperative Strahlentherapie (RT) bei lokalisiertem NB erhalten hatten. Von 1990-2000 wurden 610 Kinder eingeschlossen. Von diesen wurden 35 mit Chemotherapie, Chirurgie und RT behandelt. Die empfohlene Bestrahlungsdosis war 24 Gy bei ≤ 2 Jahren, 34 Gy bei > 2 Jahren, ± 5-Gy

  3. Utilization of result of trial seeding experimental plots in the course of rehabilitation of central tailing heap of Jan Sverma mine in Zacler

    International Nuclear Information System (INIS)

    The contribution contains results of trial seeding with application of various fertilizers and soil conditioners. A procedure for the recovery of land of the heap is presented, which includes ground shaping to achieve stability and to prevent water from uncontrolled running down during prolonged or heavy rains in the area and bio-rehabilitation to cover the heap with vegetation, i.e. to bind the surface by crops able to grow on the heap. On the basis of knowledge of specific properties of the site, a grass mixture for extensive non-agricultural utilization was proposed for the model experiment. (authors)

  4. Advances in Motivational Interviewing for Pediatric Obesity: Results of the Brief Motivational Interviewing to Reduce Body Mass Index Trial and Future Directions.

    Science.gov (United States)

    Resnicow, Ken; Harris, Donna; Wasserman, Richard; Schwartz, Robert P; Perez-Rosas, Veronica; Mihalcea, Rada; Snetselaar, Linda

    2016-06-01

    Rates of childhood obesity in the United States remain at historic highs. The pediatric primary care office represents an important yet underused setting to intervene with families. One factor contributing to underuse of the primary care setting is lack of effective available interventions. One evidence-based method to help engage and motivate patients is motivational interviewing, a client-centered and goal-oriented style of counseling used extensively to increase autonomous motivation and modify health behaviors. This article summarizes the methods and results from a large trial implemented in primary care pediatric office and concludes with recommendations for improving the intervention and increasing its dissemination.

  5. Hair-sparing whole brain radiotherapy with volumetric arc therapy in patients treated for brain metastases: dosimetric and clinical results of a phase II trial

    International Nuclear Information System (INIS)

    To report the dosimetric results and impact of volumetric arc therapy (VMAT) on temporary alopecia and hair-loss related quality of life (QOL) in whole brain radiotherapy (WBRT). The potential of VMAT-WBRT to reduce the dose to the hair follicles was assessed. A human cadaver was treated with both VMAT-WBRT and conventional opposed field (OF) WBRT, while the subcutaneously absorbed dose was measured by radiochromic films and calculated by the planning system. The impact of these dose reductions on temporary alopecia was examined in a prospective phase II trial, with the mean score of hair loss at 1 month after VMAT-WBRT (EORTC-QOL BN20) as a primary endpoint and delivering a dose of 20 Gy in 5 fractions. An interim analysis was planned after including 10 patients to rule out futility, defined as a mean score of hair loss exceeding 56.7. A secondary endpoint was the global alopecia areata severity score measured with the “Severity of Alopecia Tool” (SALT) with a scale of 0 (no hair loss) to 100 (complete alopecia). For VMAT-WBRT, the cadaver measurements demonstrated a dose reduction to the hair follicle volume of 20.5% on average and of 41.8% on the frontal-vertex-occipital medial axis as compared to OF-WBRT. In the phase II trial, a total of 10 patients were included before the trial was halted due to futility. The EORTC BN20 hair loss score following WBRT was 95 (SD 12.6). The average median dose to the hair follicle volume was 12.6 Gy (SD 0.9), corresponding to a 37% dose reduction compared to the prescribed dose. This resulted in a mean SALT-score of 75. Compared to OF-WBRT, VMAT-WBRT substantially reduces hair follicle dose. These dose reductions could not be related to an improved QOL or SALT score

  6. Design and intermediate results of the Lower Extremity Arterial Disease Event Reduction (LEADER* trial of bezafibrate in men with lower extremity arterial disease [ISRCTN41194621

    Directory of Open Access Journals (Sweden)

    Meade Thomas W

    2001-07-01

    Full Text Available Abstract Background Raised levels of both triglycerides and fibrinogen, each of which are reduced by bezafibrate, may contribute to lower extremity arterial disease (LEAD. This condition is characterized by a particularly high incidence of coronary heart disease (CHD and stroke, but is little studied thus far in randomised controlled trials. Method Patients were recruited through 85 practices in the British Medical Research Council General Practice Research Framework and through nine hospital vascular clinics. The treatment regimen, which is double-blind and placebo-controlled, is bezafibrate 400 mg/day. The 1568 patients recruited represent 86% of those eligible at screening. Results None of the anticipated side effects (mainly gastrointestinal differed between the two groups. Nearly 80% of the total person-years accrued at 3 years were spent on trial treatment. Bezafibrate significantly reduced total cholesterol by approximately 8.0% and low-density lipoprotein (LDL-cholesterol by approximately 9.0%, and increased high-density lipoprotein (HDL-cholesterol by approximately 11.0% initially, falling to about 6.0% at 3 years. Triglycerides were significantly reduced by about 23.0% and fibrinogen by about 14.0%. Plasma creatinine rose by approximately 11% in those on active treatment. All of these effects were highly significant (P Conclusion The trial recruited an unusually high proportion of eligible patients, ensuring the general applicability of its results. The fibrinogen-lowering and lipid-modifying effects of bezafibrate were confirmed. Although bezafibrate lowers fibrinogen, it has no effect on CRP; this suggests that the reduction in fibrinogen is due to an effect on its metabolism rather than suppression of an inflammatory response.

  7. Results of a 2-year randomized, controlled obesity prevention trial: Effects on diet, activity and sleep behaviors in an at-risk young adult population.

    Science.gov (United States)

    Laska, Melissa N; Lytle, Leslie A; Nanney, Marilyn S; Moe, Stacey G; Linde, Jennifer A; Hannan, Peter J

    2016-08-01

    Excess weight gain tends to occur in young adulthood. However, research examining effective weight-related interventions for this age group has been limited. As one of seven trials in the EARLY Trials consortium (Early Adult Reduction of weight through LifestYle intervention), the CHOICES Study (Choosing Healthy Options in College Environments and Settings) tested effects of a technology-integrated, young adult weight gain prevention intervention. It was a randomized controlled trial with assessments at baseline (2011) and 4-, 12- and 24-months post-intervention initiation and included 441 participants (ages 18-35) who were students at three Minnesota community colleges. The 24-month intervention included a 1-credit academic course and social networking and support online intervention. This analysis examined effects on 12 secondary behavioral outcomes across three domains: diet (fast food, sugary beverages, breakfast, at-home meal preparation), physical activity/screen time (minutes and energy expenditure in leisure time physical activity, television viewing, leisure time computer use) and sleep (hours of sleep, time required to fall asleep, days not getting enough rest, difficulty staying awake). The intervention resulted in significant reductions in fast food (p=0.007) but increases in difficulty staying awake (p=0.015). There was limited evidence of other behavior changes at 4months (0.05results (p=0.005). Additional research is needed to understand effective obesity prevention among young adults, particularly when addressing multiple weight-related outcomes.

  8. Results of a 2-year randomized, controlled obesity prevention trial: Effects on diet, activity and sleep behaviors in an at-risk young adult population.

    Science.gov (United States)

    Laska, Melissa N; Lytle, Leslie A; Nanney, Marilyn S; Moe, Stacey G; Linde, Jennifer A; Hannan, Peter J

    2016-08-01

    Excess weight gain tends to occur in young adulthood. However, research examining effective weight-related interventions for this age group has been limited. As one of seven trials in the EARLY Trials consortium (Early Adult Reduction of weight through LifestYle intervention), the CHOICES Study (Choosing Healthy Options in College Environments and Settings) tested effects of a technology-integrated, young adult weight gain prevention intervention. It was a randomized controlled trial with assessments at baseline (2011) and 4-, 12- and 24-months post-intervention initiation and included 441 participants (ages 18-35) who were students at three Minnesota community colleges. The 24-month intervention included a 1-credit academic course and social networking and support online intervention. This analysis examined effects on 12 secondary behavioral outcomes across three domains: diet (fast food, sugary beverages, breakfast, at-home meal preparation), physical activity/screen time (minutes and energy expenditure in leisure time physical activity, television viewing, leisure time computer use) and sleep (hours of sleep, time required to fall asleep, days not getting enough rest, difficulty staying awake). The intervention resulted in significant reductions in fast food (p=0.007) but increases in difficulty staying awake (p=0.015). There was limited evidence of other behavior changes at 4months (0.05results (p=0.005). Additional research is needed to understand effective obesity prevention among young adults, particularly when addressing multiple weight-related outcomes. PMID:27283096

  9. The effects of n-3 long-chain polyunsaturated fatty acid supplementation on biomarkers of kidney injury in adults with diabetes: results of the GO-FISH trial.

    Science.gov (United States)

    Miller, Edgar R; Juraschek, Stephen P; Anderson, Cheryl A; Guallar, Eliseo; Henoch-Ryugo, Karen; Charleston, Jeanne; Turban, Sharon; Bennett, Michael R; Appel, Lawrence J

    2013-06-01

    OBJECTIVE Long-chain n-3 polyunsaturated fatty acid (n-3 PUFA) supplements may have renoprotective effects in patients with diabetes, but previous trials have been inconsistent. We performed a randomized controlled trial of n-3 PUFA supplementation on urine albumin excretion and markers of kidney injury in adults with type 2 diabetes. RESEARCH DESIGN AND METHODS We conducted a randomized, placebo-controlled, two-period crossover trial to test the effects of 4 g/day of n-3 PUFA supplementation on markers of glomerular filtration and kidney injury in adults with adult-onset diabetes and greater than or equal to trace amounts of proteinuria. Each period lasted 6 weeks and was separated by a 2-week washout. The main outcome was urine albumin excretion and, secondarily, markers of kidney injury (kidney injury molecule-1, N-acetyl β-d-glucosaminidase [NAG], neutrophil gelatinase-associated lipocalin [NGAL], and liver fatty acid-binding protein [LFABP]), serum markers of kidney function (cystatin C, β2-microglobulin, and creatinine), and estimated glomerular filtration rate (eGFR). RESULTS Of the 31 participants, 29 finished both periods. A total of 55% were male, and 61% were African American; mean age was 67 years. At baseline, mean BMI was 31.6 kg/m(2), median eGFR was 76.9 mL/min/1.73 m(2), and median 24-h urine albumin excretion was 161 mg/day. Compared with placebo, n-3 PUFA had nonsignificant effects on urine albumin excretion (-7.2%; 95% CI -20.6 to 8.5; P = 0.35) and significant effects on urine NGAL excretion (-16% [-29.1 to -0.5%]; P = 0.04). There was no effect on serum markers of kidney function or eGFR. In subgroup analyses, there were significant decreases in 24-h urinary excretion of albumin, NGAL, LFABP, and NAG among participants taking medications that block the renin-angiotensin-aldosterone system (RAAS). CONCLUSIONS These results suggest a potential effect of n-3 PUFA supplementation on markers of kidney injury in patients with diabetes and early

  10. Everolimus does not further reduce polycystic liver volume when added to long acting octreotide: Results from a randomized controlled trial

    NARCIS (Netherlands)

    Chrispijn, M.; Gevers, T.J.G.; Hol, J.C.; Monshouwer, R.; Dekker, H.M.; Drenth, J.P.H.

    2013-01-01

    BACKGROUND & AIMS: Polycystic liver disease (PLD) is associated with autosomal dominant polycystic kidney disease (ADPKD) or autosomal dominant polycystic liver disease (PCLD). The resulting hepatomegaly compromises quality of life. Somatostatin analogues reduce PLD volume by approximately 5% when g

  11. Real-Time Pretreatment Review Limits Unacceptable Deviations on a Cooperative Group Radiation Therapy Technique Trial: Quality Assurance Results of RTOG 0933

    Energy Technology Data Exchange (ETDEWEB)

    Gondi, Vinai, E-mail: vgondi@chicagocancer.org [Cadence Brain Tumor Center and CDH Proton Center, Warrenville, Illinois (United States); University of Wisconsin School of Medicine & Public Health, Madison, Wisconsin (United States); Cui, Yunfeng [Duke University School of Medicine, Durham, North Carolina (United States); Mehta, Minesh P. [University of Maryland School of Medicine, Baltimore, Maryland (United States); Manfredi, Denise [Radiation Therapy Oncology Group—RTQA, Philadelphia, Pennsylvania (United States); Xiao, Ying; Galvin, James M. [Thomas Jefferson University Hospital, Philadelphia, Pennsylvania (United States); Rowley, Howard [University of Wisconsin School of Medicine & Public Health, Madison, Wisconsin (United States); Tome, Wolfgang A. [Montefiore Medical Center and Institute for Onco-Physics, Albert Einstein College of Medicine of Yeshiva University, Bronx, New York (United States)

    2015-03-01

    Purpose: RTOG 0933 was a phase II trial of hippocampal avoidance during whole brain radiation therapy for patients with brain metastases. The results demonstrated improvement in short-term memory decline, as compared with historical control individuals, and preservation of quality of life. Integral to the conduct of this trial were quality assurance processes inclusive of pre-enrollment credentialing and pretreatment centralized review of enrolled patients. Methods and Materials: Before enrolling patients, all treating physicians and sites were required to successfully complete a “dry-run” credentialing test. The treating physicians were credentialed based on accuracy of magnetic resonance imaging–computed tomography image fusion and hippocampal and normal tissue contouring, and the sites were credentialed based on protocol-specified dosimetric criteria. Using the same criteria, pretreatment centralized review of enrolled patients was conducted. Physicians enrolling 3 consecutive patients without unacceptable deviations were permitted to enroll further patients without pretreatment review, although their cases were reviewed after treatment. Results: In all, 113 physicians and 84 sites were credentialed. Eight physicians (6.8%) failed hippocampal contouring on the first attempt; 3 were approved on the second attempt. Eight sites (9.5%) failed intensity modulated radiation therapy planning on the first attempt; all were approved on the second attempt. One hundred thirteen patients were enrolled in RTOG 0933; 100 were analyzable. Eighty-seven cases were reviewed before treatment; 5 (5.7%) violated the eligibility criteria, and 21 (24%) had unacceptable deviations. With feedback, 18 cases were approved on the second attempt and 2 cases on the third attempt. One patient was treated off protocol. Twenty-two cases were reviewed after treatment; 1 (4.5%) violated the eligibility criteria, and 5 (23%) had unacceptable deviations. Conclusions: Although >95% of the

  12. A dermocosmetic containing bakuchiol, Ginkgo biloba extract and mannitol improves the efficacy of adapalene in patients with acne vulgaris: result from a controlled randomized trial

    Directory of Open Access Journals (Sweden)

    Poláková K

    2015-04-01

    Full Text Available Katarína Poláková,1 Aurélie Fauger,2 Michèle Sayag,2 Eric Jourdan2 1Saint Elisabeth´s Oncological Institute, Bratislava, Slovakia; 2Laboratoire Bioderma, Lyon, France Background: Acne vulgaris is an inflammatory disorder of the pilosebaceous unit. Aim: To confirm that BGM (bakuchiol, Ginkgo biloba extract, and mannitol complex increases the established clinical efficacy of adapalene 0.1% gel in patients with acne. Methods: A clinical trial was conducted in acne patients. A total of 111 subjects received adapalene 0.1% gel and BGM complex or vehicle cream for 2 months. Assessments comprised Investigator Global Assessment (IGA, global efficacy, seborrhea intensity, inflammatory and non-inflammatory lesions, and subject perception, as well as overall safety and local tolerance and quality of life. Results: At the end of the trial, inflammatory and non-inflammatory lesions, IGA, global efficacy, and seborrhea intensity had significantly improved in both treatment groups. Differences were statistically significant (P<0.05 in favor of BGM complex for inflammatory lesions as well as IGA and seborrhea intensity. Global efficacy assessments and subject perception confirmed the superiority of BGM complex-including treatment over the comparative combination. Quality of life had improved more with the active combination than with the vehicle combination. In the active group, four subjects had to interrupt temporarily BGM complex and 12 adapalene compared to seven subjects interrupting the vehicle and eleven adapalene in the vehicle group. One subject withdrew from the trial due to an allergy to adapalene. The majority of all events were mild. Conclusion: BGM complex improves the treatment outcome of adapalene 0.1% gel in patients with acne vulgaris. Overall, safety and local tolerance of BGM complex were good. Keywords: adapalene, acne vulgaris, bakuchiol, BGM complex, P. acnes, sebum

  13. Cognitive Effects of High-Frequency rTMS in Schizophrenia Patients With Predominant Negative Symptoms: Results From a Multicenter Randomized Sham-Controlled Trial.

    Science.gov (United States)

    Hasan, Alkomiet; Guse, Birgit; Cordes, Joachim; Wölwer, Wolfgang; Winterer, Georg; Gaebel, Wolfgang; Langguth, Berthold; Landgrebe, Michael; Eichhammer, Peter; Frank, Elmar; Hajak, Göran; Ohmann, Christian; Verde, Pablo E; Rietschel, Marcella; Ahmed, Raees; Honer, William G; Malchow, Berend; Karch, Susanne; Schneider-Axmann, Thomas; Falkai, Peter; Wobrock, Thomas

    2016-05-01

    Cognitive impairments are one of the main contributors to disability and poor long-term outcome in schizophrenia. Proof-of-concept trials indicate that repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (DLPFC) has the potential to improve cognitive functioning. We analyzed the effects of 10-Hz rTMS to the left DLPFC on cognitive deficits in schizophrenia in a large-scale and multicenter, sham-controlled study. A total of 156 schizophrenia patients with predominant negative symptoms were randomly assigned to a 3-week intervention (10-Hz rTMS, 15 sessions, 1000 stimuli per session) with either active or sham rTMS. The Rey Auditory Verbal Learning Test, Trail Making Test A and B, Wisconsin Card Sorting Test, Digit Span Test, and the Regensburg Word Fluency Test were administered before intervention and at day 21, 45, and 105 follow-up. From the test results, a neuropsychological composite score was computed. Both groups showed no differences in any of the outcome variables before and after intervention. Both groups improved markedly over time, but effect sizes indicate a numeric, but nonsignificant superiority of active rTMS in certain cognitive tests. Active 10-Hz rTMS applied to the left DLPFC for 3 weeks was not superior to sham rTMS in the improvement of various cognitive domains in schizophrenia patients with predominant negative symptoms. This is in contrast to previous preliminary proof-of-concept trials, but highlights the need for more multicenter randomized controlled trials in the field of noninvasive brain stimulation. PMID:26433217

  14. Feasibility of isometric spinal muscle training in patients with bone metastases under radiation therapy - first results of a randomized pilot trial

    International Nuclear Information System (INIS)

    Spinal bone metastases are commonly diagnosed in cancer patients. The consequences are pain both at rest and under exercise, impairment of activities of daily life (ADL), reduced clinical performance, the risk of pathological fractures, and neurological deficits. The aim of this randomized, controlled pilot trial was to investigate the feasibility of muscle-training exercises in patients with spinal bone metastases under radiotherapy. Secondary endpoints were local control, pain response and survival. This study was a prospective, randomized, monocentre, controlled explorative intervention trial to determine the multidimensional effects of exercises for strengthening the paravertebral muscles. On the days of radiation treatment, patients in the control group were physically treated in form of respiratory therapy. Sixty patients were randomized between September 2011 and March 2013 into one of the two groups: differentiated resistance training or physical measure with thirty patients in each group. The resistance training of the paravertebral muscles was feasible in 83.3% of patients (n = 25). Five patients died during the first three months. The exercise group experienced no measurable side effects. “Chair stand test” in the intervention group was significant enhanced with additionally improved analgesic efficiency. Patients in intervention group improved in pain score (VAS, 0–10) over the course (p < .001), and was significant better between groups (p = .003) after 3 months. The overall pain response showed no significant difference between groups (p = .158) There was no significant difference in overall and bone survival (survival from first diagnosed bone metastases to death). Our trial demonstrated safety and feasibility of an isometric resistance training in patients with spinal bone metastases. The results offer a rationale for future large controlled investigations to confirm these findings.

  15. Results from an experimental trial at a Head Start center to evaluate two meal service approaches to increase fruit and vegetable intake of preschool aged children

    Directory of Open Access Journals (Sweden)

    Harnack Lisa J

    2012-04-01

    Full Text Available Abstract Background Strategies to increase fruit and vegetable consumption of preschool aged children are needed. Objectives Evaluate the independent effects of the following meal service strategies on intake of fruits and vegetables of preschool children: 1. Serving fruits and vegetables in advance of other menu items as part of traditional family style meal service; and 2. Serving meals portioned and plated by providers. Methods Fifty-three preschool aged children completed a randomized crossover experiment conducted at a Head Start center in Minneapolis, MN. Over a six week trial period each of the experimental meal service strategies (serving fruits and vegetable first and serving meals portioned by providers was implemented during lunch service for two one-week periods. Two one-week control periods (traditional family style meal service with all menu items served at once were also included over the six week trial period. Childrens lunch intake was observed as a measure of food and nutrient intake during each experimental condition. Results Fruit intake was significantly higher (p Conclusions Serving fruits in advance of other meal items may be a low cost easy to implement strategy for increasing fruit intake in young children. However, serving vegetables first does not appear to increase vegetable intake. Results provide support for current recommendations for traditional family style meal service in preschool settings.

  16. The impact of therapy for childhood acute lymphoblastic leukaemia on intelligence quotients; results of the risk-stratified randomized central nervous system treatment trial MRC UKALL XI

    Directory of Open Access Journals (Sweden)

    Vargha-Khadem Faraneh

    2011-10-01

    Full Text Available Abstract Background The MRC UKALLXI trial tested the efficacy of different central nervous system (CNS directed therapies in childhood acute lymphoblastic leukaemia (ALL. To evaluate morbidity 555/1826 randomised children underwent prospective psychological evaluations. Full Scale, verbal and performance IQs were measured at 5 months, 3 years and 5 years. Scores were compared in; (1 all patients (n = 555 versus related controls (n = 311, (2 low-risk children (presenting white cell count (WCC 9/l randomised to intrathecal methotrexate (n = 197 versus intrathecal and high-dose intravenous methotrexate (HDM (n = 202, and (3 high-risk children (WCC ≥ 50 × 109/l, age ≥ 2 years randomised to HDM (n = 79 versus cranial irradiation (n = 77. Results There were no significant differences in IQ scores between the treatment arms in either low- or high-risk groups. Despite similar scores at baseline, results at 3 and 5 years showed a significant reduction of between 3.6 and 7.3 points in all three IQ scores in all patient groups compared to controls (P Conclusion Children with ALL are at risk of CNS morbidity, regardless of the mode of CNS-directed therapy. Further work needs to identify individuals at high-risk of adverse CNS outcomes. Trial registration ISRCTN: ISRCTN16757172

  17. Telomerase-pulsed dendritic cells: preclinical results and outcome of a clinical phase I/II trial in patients with metastatic renal cell carcinoma

    Directory of Open Access Journals (Sweden)

    Schmiedel, Alexandra

    2006-02-01

    Full Text Available Objective: Therapeutic vaccination with dendritic cells (DC showed promising results in first clinical trials in cases of metastatic renal cell carcinoma (RCC. Human telomerase reverse transcriptase (hTERT could be a potential target because it is detectable in more than 85% of human tumors including RCC. Design: 10 patients with progressive metastatic RCC were enrolled in a clinical phase I/II trial using DC pulsed with hTERT-peptide. Beside toxicity and feasibility aspects, a complex immune monitoring including in vitro data were evaluated. In addition to detection of tumor-specific effector cells we investigated their functionality like IFN-γ secretion and cytotoxic activity against tumor cells. Results: The vaccine was well tolerated. Two patients showed a mixed response (MR and one patient a stable disease (SD. Interestingly, responders showed cytotoxic activity already before start of therapy and there was a significant increase in cytotoxic activity of effector cells from all responders (SD and MR patients after the first vaccination. In contrast non-responders showed no cytotoxic activity before and during treatment. Therefore, cytotoxic activity might be used as a predictive marker in the future. Tetramer staining detected higher amounts of tumor-specific cytotoxic cells in responding patients compared to non-responders. Also, responders possessed increasing amounts of IFN-γ producing immunological effector cells. Conclusion: Telomerase-pulsed DC could enhance a tumor-specific immune response against RCC.

  18. 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)

    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

  19. Breast-conserving therapy with partial or whole breast irradiation: Ten-year results of the Budapest randomized trial

    International Nuclear Information System (INIS)

    Background and purpose: To report the long-term results of a single-institution randomized study comparing the results of breast-conserving treatment with partial breast irradiation (PBI) or conventional whole breast irradiation (WBI). Patients and methods: Between 1998 and 2004, 258 selected women with pT1 pN0-1mi M0, grade 1–2, non-lobular breast cancer without the presence of extensive intraductal component and resected with negative margins were randomized after BCS to receive 50 Gy WBI (n = 130) or PBI (n = 128). The latter consisted of either 7 × 5.2 Gy high-dose-rate (HDR) multi-catheter brachytherapy (BT; n = 88) or 50 Gy electron beam (EB) irradiation (n = 40). Primary endpoint was local recurrence (LR) as a first event. Secondary endpoints were overall survival (OS), cancer-specific survival (CSS), disease-free survival (DFS), and cosmetic results. Results: After a median follow up of 10.2 years, the ten-year actuarial rate of LR was 5.9% and 5.1% in PBI and WBI arms, respectively (p = 0.77). There was no significant difference in the ten-year probability of OS (80% vs 82%), CSS (94% vs 92%), and DFS (85% vs 84%), either. The rate of excellent-good cosmetic result was 81% in the PBI, and 63% in the control group (p < 0.01). Conclusions: Partial breast irradiation delivered by interstitial HDR BT or EB for a selected group of early-stage breast cancer patients produces similar ten-year results to those achieved with conventional WBI. Significantly better cosmetic outcome can be achieved with HDR BT implants compared with the outcome after WBI

  20. Toxicity report of once weekly radiation therapy for low-risk prostate adenocarcinoma: preliminary results of a phase I/II trial

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    Van Nguyen Thu

    2011-09-01

    Full Text Available Abstract Background Increasing clinical data supports a low α/β ratio for prostate adenocarcinoma, potentially lower than that of surrounding normal tissues. A hypofractionated, weekly radiation therapy (RT schedule should result in improved tumour control, reduced acute toxicity, and similar or decreased late effects. We report the toxicity profile of such treatment. Materials and Methods We conducted a multi-institution phase I/II trial of three-dimensional conformal radiation therapy (3D-CRT for favourable-risk prostate cancer (T1a-T2a, Gleason ≤ 6 and PSA Results Between 2006 and 2008, 80 patients were treated. No treatment interruptions occurred. The median follow-up is 33 months (range: 20-51. Maximal grade 1, 2, and 3 acute ( Conclusions Weekly RT with 45 Gy in 9 fractions is feasible and results in comparable toxicity. Long term tumour control and survival remain to be assessed.

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

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

    2014-09-25

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

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

    Directory of Open Access Journals (Sweden)

    Rutten Marianne J

    2012-01-01

    Full Text Available Abstract Background 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. Methods 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. Discussion 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

  3. Intervention to prevent further falls in older people who call an ambulance as a result of a fall: a protocol for the iPREFER randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background An increasing number of falls result in an emergency call and the subsequent dispatch of paramedics. In the absence of physical injury, abnormal physiological parameters or change in usual functional status, it could be argued that routine conveyance by ambulance to the Emergency Department (ED) is not the most effective or efficient use of resources. Further, it is likely that non-conveyed older fallers have the potential to benefit from timely access to fall risk assessment and intervention. The aim of this randomised controlled trial is to evaluate the effect of a timely and tailored falls assessment and management intervention on the number of subsequent falls and fall-related injuries for non-conveyed older fallers. Methods Community dwelling people aged 65 years or older who are not conveyed to the ED following a fall will be eligible to be visited at home by a research physiotherapist. Consenting participants will receive individualised intervention strategies based on risk factors identified at baseline. All pre-test measures will be assessed prior to randomisation. Post-test measures will be undertaken by a researcher blinded to group allocation 6 months post-baseline. Participants in the intervention group will receive individualised pro-active fall prevention strategies from the clinical researcher to ensure that risk factors are addressed adequately and interventions carried out. The primary outcome measure will be the number of falls recorded by a falls diary over a 12 month period. Secondary outcome measures assessed six months after baseline will include the subsequent use of medical and emergency services and uptake of recommendations. Data will be analysed using the intention-to-treat principle. Discussion As there is currently little evidence regarding the effectiveness or feasibility of alternate models of care following ambulance non-conveyance of older fallers, there is a need to explore assessment and intervention programs to

  4. The Well London program - a cluster randomized trial of community engagement for improving health behaviors and mental wellbeing: baseline survey results

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    Phillips Gemma

    2012-07-01

    Full Text Available Abstract Background The Well London program used community engagement, complemented by changes to the physical and social neighborhood environment, to improve physical activity levels, healthy eating, and mental wellbeing in the most deprived communities in London. The effectiveness of Well London is being evaluated in a pair-matched cluster randomized trial (CRT. The baseline survey data are reported here. Methods The CRT involved 20 matched pairs of intervention and control communities (defined as UK census lower super output areas (LSOAs; ranked in the 11% most deprived LSOAs in London by the English Indices of Multiple Deprivation across 20 London boroughs. The primary trial outcomes, sociodemographic information, and environmental neighbourhood characteristics were assessed in three quantitative components within the Well London CRT at baseline: a cross-sectional, interviewer-administered adult household survey; a self-completed, school-based adolescent questionnaire; a fieldworker completed neighborhood environmental audit. Baseline data collection occurred in 2008. Physical activity, healthy eating, and mental wellbeing were assessed using standardized, validated questionnaire tools. Multiple imputation was used to account for missing data in the outcomes and other variables in the adult and adolescent surveys. Results There were 4,107 adults and 1,214 adolescent respondents in the baseline surveys. The intervention and control areas were broadly comparable with respect to the primary outcomes and key sociodemographic characteristics. The environmental characteristics of the intervention and control neighborhoods were broadly similar. There was greater between-cluster variation in the primary outcomes in the adult population compared to the adolescent population. Levels of healthy eating, smoking, and self-reported anxiety/depression were similar in the Well London adult population and the national Health Survey for England. Levels of

  5. A phase I/II trial of intraoperative breast radiotherapy in an Asian population: 5-year results of local control and cosmetic outcome

    International Nuclear Information System (INIS)

    To date, there are no reports of intraoperative radiotherapy (IORT) use with long-term follow up as a method of accelerated partial breast irradiation (APBI) in Asian countries. We initiated a prospective phase I/II clinical trial of IORT in Japan in 2007, and herein, we report the 5-year follow-up results. The following inclusion criteria were used for enrollment in the trial: (1) tumor size < 2.5 cm, (2) desire for breast-conserving surgery, (3) age >50 years, and (4) negative margins after resection. In February 2009, the eligibility criteria were changed to include only patients with sentinel lymph node-negative disease. In phase I, the radiotherapy dose was escalated from 19 Gy/fr to 21 Gy/fr, incremented by 1 Gy per step, with 3 patients in each step. Doses were escalated after all patients in the preceding cohort had completed treatment and exhibited only grade 1 or 2 toxicities at a given dose level. The recommended phase II dose was set at 21 Gy at 90 % isodose. The primary endpoint was early toxicity. Secondary endpoints were long-term efficacy and late toxicity. In addition, Hypertrophic scarring was evaluated retrospectively as a cosmetic outcome by a radiation oncologist. Between December 2007 and March 2010, 32 women with breast cancer were enrolled in the trial. The median age was 65 years (51–80 years), and the median follow-up time was 6 years. No recurrence or metastasis was observed in any patient. Grade 2 fibrosis was detected in 3 patients as an acute adverse event and in 2 patients as a late adverse event. Ten patients developed a hypertrophic scar 1 year after the IORT; the number of patients decreased to 7 in the 3 years of follow-up. The first group of female Asian patients tolerated the treatment with IORT in this Phase I/II study and remained recurrence-free for more than 5 years after treatment. However, 24 % of the patients developed hypertrophic scarring, an event that is being further examined in our ongoing multi-center Phase II

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

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    Gabrail N

    2015-03-01

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

  7. Single-session interventions for problem gambling may be as effective as longer treatments: Results of a randomized control trial.

    Science.gov (United States)

    Toneatto, Tony

    2016-01-01

    Empirically supported treatments for problem gambling tend to be multimodal combining cognitive, behavior and motivational interventions. Since problem gamblers often prefer briefer treatments it is important that interventions adopt strategies that are optimally effective. In this study, 99 community-recruited problem gamblers (74% male, mean age: 47.5 years) were randomized to one of four treatments: six sessions of cognitive therapy, behavior therapy, and motivational therapy or a single-session intervention. The sample was followed up for 12 months post-treatment. In both the Intent-to-Treat and Completer statistical analyses, no significant group differences on key gambling variables (i.e., frequency, expenditures, severity) were found. All four treatments showed significant improvement as a result of treatment that endured throughout the follow-up period. These results, although preliminary, suggest that very brief, single-session interventions may be as effective as longer treatments.

  8. A randomised phase II trial of weekly high-dose 5-fluorouracil with and without folinic acid and cisplatin in patients with advanced biliary tract carcinoma: results of the 40955 EORTC trial.

    NARCIS (Netherlands)

    Ducreux, M.; Cutsem, E. van; Laethem, J. van; Gress, T.M.; Jeziorski, K.; Rougier, P.; Wagener, T.; Anak, O.; Baron, B.; Nordlinger, B.

    2005-01-01

    Previous small phase II trials have demonstrated that the combination of 5-fluorouracil (5FU) and cisplatin(CDDP) could have clinical activity in metastatic biliary tract cancer. This randomised phase II trial was designed to assess the activity and safety of a high-dose infusional weekly 5FU alone

  9. Results from phase III clinical trials with radachlorine for photodynamic therapy of pre-cancer and early cancer of cervix

    OpenAIRE

    E. V. Filonenko; L. G. Serova; V. I. Ivanova-Radkevich

    2015-01-01

    The results of clinical study for efficacy of photodynamic therapy (PDT) with radachlorine in patients with pre-cancer and cancer of cervix are represented. The study enrolled 30 patients including 4 patients with cervical erosion, 5 patients with cervical intraepithelial neoplasia II, 13 patients with cervical intraepithelial neoplasia III, 4 patients with carcinoma in situ and 4 patients with cervical cancer stage Ia. Radachlorine was administrated as single 30 minute intravenous injection ...

  10. Bactercline®-coated implants: Clinical results up to 1 year after loading from a controlled clinical trial

    Science.gov (United States)

    Carinci, Francesco; Grecchi, Emma; Bignozzi, Carlo Alberto; Murmura, Giovanna; Piattelli, Adriano; Scarano, Antonio

    2012-01-01

    Background: Titanium dioxide exists in three different crystal lattices, anatase, rutile, and brookite. Anatase coating releases, under ultraviolet (UV) irradiation, free radicals such as ·OH, O2-, HO2-, and H2O2. This potent oxidizing power characteristically results in the lysis of bacteria and other organic substances. The purpose of this study was to evaluate the bone response to implants made of titanium alloy or coated with a new combination of anatase and Bactercline® product. Materials and Methods: In the period between July 2009 and June 2010, 26 patients (10 females and 16 males; median age 51 ± 11 years, min. 27 years, max. 72 years) were operated and 62 implants were inserted. Lost fixtures and peri-implant bone resorption were considered as predictors of clinical outcomes. Pearson χ2-test was used. Prosthesis and implant failures, any complications after loading, and peri-implant marginal bone-level changes were assessed by a masked assessor. All patients were followed up to 1 year after loading. Results: No implant was lost. Average bone resorption around implant was 0.33 mm (both for 25 standard and 37 Bactercline-coated implants), and thus no statistical difference was detected. Conclusion: These results shown that no adverse effects on osseo-integration were present. PMID:23814572

  11. Decline of Cosmetic Outcomes Following Accelerated Partial Breast Irradiation Using Intensity Modulated Radiation Therapy: Results of a Single-Institution Prospective Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Liss, Adam L. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Ben-David, Merav A. [Department of Radiation Oncology, The Sheba Medical Center, Ramat Gan (Israel); Jagsi, Reshma; Hayman, James A. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Griffith, Kent A. [Biostatistics Unit, University of Michigan, Ann Arbor, Michigan (United States); Moran, Jean M.; Marsh, Robin B. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Pierce, Lori J., E-mail: ljpierce@umich.edu [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States)

    2014-05-01

    Purpose: To report the final cosmetic results from a single-arm prospective clinical trial evaluating accelerated partial breast irradiation (APBI) using intensity modulated radiation therapy (IMRT) with active-breathing control (ABC). Methods and Materials: Women older than 40 with breast cancer stages 0-I who received breast-conserving surgery were enrolled in an institutional review board-approved prospective study evaluating APBI using IMRT administered with deep inspiration breath-hold. Patients received 38.5 Gy in 3.85-Gy fractions given twice daily over 5 consecutive days. The planning target volume was defined as the lumpectomy cavity with a 1.5-cm margin. Cosmesis was scored on a 4-category scale by the treating physician. Toxicity was scored according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0). We report the cosmetic and toxicity results at a median follow-up of 5 years. Results: A total of 34 patients were enrolled. Two patients were excluded because of fair baseline cosmesis. The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women at a median follow-up of 2.5 years. At a median follow-up of 5 years, further decline in the cosmetic outcome was observed in 5 women. Cosmesis at the time of last assessment was 43.3% excellent, 30% good, 20% fair, and 6.7% poor. Fibrosis according to CTCAE at last assessment was 3.3% grade 2 toxicity and 0% grade 3 toxicity. There was no correlation of CTCAE grade 2 or greater fibrosis with cosmesis. The 5-year rate of local control was 97% for all 34 patients initially enrolled. Conclusions: In this prospective trial with 5-year median follow-up, we observed an excellent rate of tumor control using IMRT-planned APBI. Cosmetic outcomes, however, continued to decline, with 26.7% of women having a fair to poor cosmetic result. These results underscore the need for continued cosmetic assessment for patients treated with APBI by technique.

  12. Decline of Cosmetic Outcomes Following Accelerated Partial Breast Irradiation Using Intensity Modulated Radiation Therapy: Results of a Single-Institution Prospective Clinical Trial

    International Nuclear Information System (INIS)

    Purpose: To report the final cosmetic results from a single-arm prospective clinical trial evaluating accelerated partial breast irradiation (APBI) using intensity modulated radiation therapy (IMRT) with active-breathing control (ABC). Methods and Materials: Women older than 40 with breast cancer stages 0-I who received breast-conserving surgery were enrolled in an institutional review board-approved prospective study evaluating APBI using IMRT administered with deep inspiration breath-hold. Patients received 38.5 Gy in 3.85-Gy fractions given twice daily over 5 consecutive days. The planning target volume was defined as the lumpectomy cavity with a 1.5-cm margin. Cosmesis was scored on a 4-category scale by the treating physician. Toxicity was scored according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE version 3.0). We report the cosmetic and toxicity results at a median follow-up of 5 years. Results: A total of 34 patients were enrolled. Two patients were excluded because of fair baseline cosmesis. The trial was terminated early because fair/poor cosmesis developed in 7 of 32 women at a median follow-up of 2.5 years. At a median follow-up of 5 years, further decline in the cosmetic outcome was observed in 5 women. Cosmesis at the time of last assessment was 43.3% excellent, 30% good, 20% fair, and 6.7% poor. Fibrosis according to CTCAE at last assessment was 3.3% grade 2 toxicity and 0% grade 3 toxicity. There was no correlation of CTCAE grade 2 or greater fibrosis with cosmesis. The 5-year rate of local control was 97% for all 34 patients initially enrolled. Conclusions: In this prospective trial with 5-year median follow-up, we observed an excellent rate of tumor control using IMRT-planned APBI. Cosmetic outcomes, however, continued to decline, with 26.7% of women having a fair to poor cosmetic result. These results underscore the need for continued cosmetic assessment for patients treated with APBI by technique

  13. Cost-effectiveness of internet-based cognitive behavior therapy for irritable bowel syndrome: results from a randomized controlled trial

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    Paxling Björn

    2011-04-01

    Full Text Available Abstract Background Irritable Bowel Syndrome (IBS is highly prevalent and is associated with a substantial economic burden. Cognitive behavior therapy (CBT has been shown to be effective in treating IBS. The aim of this study was to evaluate the cost-effectiveness of a new treatment alternative, internet-delivered CBT based on exposure and mindfulness exercises. Methods Participants (N = 85 with IBS were recruited through self-referral and were assessed via a telephone interview and self-report measures on the internet. Participants were randomized to internet-delivered CBT or to a discussion forum. Economic data was assessed at pre-, post- and at 3-month and 1 year follow-up. Results Significant cost reductions were found for the treatment group at $16,806 per successfully treated case. The cost reductions were mainly driven by reduced work loss in the treatment group. Results were sustained at 3-month and 1 year follow-up. Conclusions Internet-delivered CBT appears to generate health gains in IBS treatment and is associated with cost-savings from a societal perspective.

  14. Results from phase III clinical trials with radachlorine for photodynamic therapy of pre-cancer and early cancer of cervix

    Directory of Open Access Journals (Sweden)

    E. V. Filonenko

    2015-01-01

    Full Text Available The results of clinical study for efficacy of photodynamic therapy (PDT with radachlorine in patients with pre-cancer and cancer of cervix are represented. The study enrolled 30 patients including 4 patients with cervical erosion, 5 patients with cervical intraepithelial neoplasia II, 13 patients with cervical intraepithelial neoplasia III, 4 patients with carcinoma in situ and 4 patients with cervical cancer stage Ia. Radachlorine was administrated as single 30 minute intravenous injection at dose of 1,0 mg/kg of body weight 3 h before irradiation (wavelength of 662 nm, light dose of 300–350 J/cm2. The results of treatment in 26 (86,7% patients was assessed as complete tumor regression and in 4 (13,3% patients — as partial regression. In cervical erosion, intraepithelial neoplasia II and carcinoma in situ groups total regression was in all cases. In the cervical intraepithelial neoplasia III group total regression after first course of PDT was achieved in 77% of patients, in cervical cancer stage Ia group – in 75% of patients. From 3 to 6 months after first course of treatment all patients with partial tumor regression underwent the second course of PDT with complete regression. There were no side-effects due to radachorine or PDT in the course of treatment and during follow-up. Thus, PDT with Russian photosensitizer radachlorine showed high efficiency for treatment of pre-cancer and cancer of cervix. 

  15. Five-year results of a prospective randomised controlled clinical trial of posterior computer-aided design-computer-aided manufacturing ZrSiO4 -ceramic crowns.

    Science.gov (United States)

    Passia, N; Stampf, S; Strub, J R

    2013-08-01

    The aim of this prospective randomised controlled clinical trial was to evaluate the clinical outcome of shrinkage-free ZrSiO4 -ceramic full-coverage crowns on premolars and molars in comparison with conventional gold crowns over a 5-year period. Two hundred and twenty-three patients were included and randomly divided into two treatment groups. One hundred and twenty-three patients were restored with 123 ZrSiO4 -ceramic crowns, and 100 patients received 100 gold crowns, which served as the control. All crowns were conventionally cemented with glass-ionomer cement. After an observation period of 6, 12, 24, 36, 48 and 60 months, the survival probability (Kaplan-Meier) for the shrinkage-free ZrSiO4 -ceramic crowns was 98·3%, 92·0%, 84·7%, 79% and 73·2% and for the gold crowns, 99%, 97·9%, 95·7%, 94·6% and 92·3%, respectively. The difference between the test and control group was statistically significant (P = 0·0027). The gold crowns showed a better marginal integrity with less marginal discoloration than the ceramic crowns. The most common failure in the ceramic crown group was fracture of the crown. The 60-month results of this prospective randomised controlled clinical trial suggest that the use of these shrinkage-free ZrSiO4 -ceramic crowns in posterior tooth restorations cannot be recommended.

  16. Effectiveness of an intervention at construction worksites on work engagement, social support, physical workload, and need for recovery: results from a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Oude Hengel Karen M

    2012-11-01

    Full Text Available Abstract Background To prolong sustainable healthy working lives of construction workers, a worksite prevention program was developed which aimed to improve the health and work ability of construction workers. The aim of the current study was to investigate the effectiveness of this program on social support at work, work engagement, physical workload and need for recovery. Methods Fifteen departments from six construction companies participated in this cluster randomized controlled trial; 8 departments (n=171 workers were randomized to an intervention group and 7 departments (n=122 workers to a control group. The intervention consisted of two individual training sessions of a physical therapist to lower the physical workload, a Rest-Break tool to improve the balance between work and recovery, and two empowerment training sessions to increase the influence of the construction workers at the worksite. Data on work engagement, social support at work, physical workload, and need for recovery were collected at baseline, and at three, six and 12 months after the start of the intervention using questionnaires. Results No differences between the intervention and control group were found for work engagement, social support at work, and need for recovery. At 6 months follow-up, the control group reported a small but statistically significant reduction of physical workload. Conclusion The intervention neither improved social support nor work engagement, nor was it effective in reducing the physical workload and need for recovery among construction workers. Trial registration NTR1278

  17. Association of a multibiomarker disease activity score at multiple time-points with radiographic progression in rheumatoid arthritis: results from the SWEFOT trial

    Science.gov (United States)

    Hambardzumyan, Karen; Bolce, Rebecca J; Saevarsdottir, Saedis; Forslind, Kristina; Wallman, Johan K; Cruickshank, Scott E; Sasso, Eric H; Chernoff, David; van Vollenhoven, Ronald F

    2016-01-01

    Objectives In rheumatoid arthritis (RA), predictive biomarkers for subsequent radiographic progression (RP) could improve therapeutic choices for individual patients. We previously showed that the multibiomarker disease activity (MBDA) score in patients with newly diagnosed RA identified patients at risk for RP. We evaluated the MBDA score at multiple time-points as a predictor of RP during 2 years of follow-up. Methods A subset of patients with RA (N=220) from the Swedish Farmacotherapy (SWEFOT) trial were analysed for MBDA score, disease activity score of 28 joints (DAS28), C reactive protein (CRP) and erythrocyte sedimentation rate (ESR) at baseline (BL), month 3 and year 1, for predicting RP based on modified Sharp/van der Heijde scores at BL, year 1 and year 2. Results Patients with persistently low MBDA (44) MBDA scores. Among methotrexate non-responders with a high MBDA score at BL or month 3, significantly more of those who received triple therapy had RP at year 2 compared with those who received antitumour necrosis factor therapy. Conclusions Measuring the MBDA score both before and during treatment in RA was useful for the assessment of individual patient risk for RP during 2 years of follow-up. In comparison with low CRP, ESR or DAS28, a low MBDA score at any time-point was associated with numerically lower proportions of RP. Trial registration number NCT00764725. PMID:26958364

  18. The influence of passive and active moral training on medical university on changes of students’ moral competence index – results from randomized single blinded trial

    Directory of Open Access Journals (Sweden)

    Izabela Rzymska

    2014-03-01

    Full Text Available Introduction and Objectives. Human’s life as well as medical professions consist of many moral dilemmas. The aim of our study was to evaluate moral competences of midwifery students during their whole university education (3 year course based on their moral competences C-index. Material and Method: We performed randomized single blinded 3-year follow-up trial of 72 midwifery students. Standard Moral Judgment Test (MJT By Georg Lind was used accompanied by own questionnaire. Moral competences were calculated (C-index according to Lind’s methodology. Subjects were also divided into active and passive ethics training to search for differences. Results. C-index varied during studies insignificant (p=0.14. Randomized groups were equal at the beginning point, no significant differences were noticed. Active ethics teaching did not increase C-index compared to controls in all measuring points (P1-P4, respectively p=0,41 and p=0,38. Conclusions. During 3 year studies at medical university moral competences measured by C-index varied insignificantly, but simultaneously the change in C-index was dependent on its value at the beginning of the trial. There was not statistically significant influence of active ethic’s teaching compared to controls. Among social factors parents have strongest influence on students’ morality, but growing role of Medical University in this hierarchy raises hopes for improvement in effectiveness of training in ethics.

  19. [Semiologic value and optimum stimuli trial during the vibratory test: results of a 3D analysis of nystagmus].

    Science.gov (United States)

    Dumas, G; Michel, J; Lavieille, J P; Ouedraogo, E

    2000-11-01

    Nystagmus signaling vestibular dysfunction was observed after vibratory stimulation with a 100 Hz ABC stimulator in a population of 36 patients with unilateral labyrinthine pathology (ULP) (pre and postoperative neuromas, vestibular neurectomies) and 10 patients with vestibular neuritis. The stimulus was applied on 3 bony points of the skull (vertex and 2 mastoids) and 2 muscular points of the neck (right and left posterior cervical region). These results were compared with those in 95 normal subjects and 19 cases of central disease and were correlated on the same day with results of the caloric test and head shaking test (HST). A consistent nystagmus was found in only 6 % of the normal subjects (specificity 94 %) and in 10 % of the central lesions, but in 94 % of the 36 peripheral ULP. The sensitivity of the test was equivalent to the HST. The signal was optimized in 30 patients: stimulus frequency, amplitude, stimulator mass, form of the contact, patient tolerance. The best results were obtained for a frequency of 100 Hz and an amplitude of 0.5 mm (there was no response under 0.1 mm vibration amplitude). Under videoscopy and 3D videonystagmography, the direction or side of the nystagmus was constant, but its axis (horizontal, oblique or rotational) changed according to the location of the stimulator: on the mastoid (elective location of stimulation with responses in 94 % of cases) the axis was most often horizontal or horizontal rotational. On the vertex location (where nystagmus was observed in 60 % of cases) the axis of nystagmus was most often rotational or oblique and sometimes horizontal-rotational. The nystagmus showed short latency (less than 200 ms). It started and stopped as stimulation was initiated and interrupted. Nystagmus persisted for the duration of patient tolerance. This nystagmus generally signifies unilateral vestibular weakness rather than vestibular predominance. It is a good indicator of unilateral vestibular dysfunction and could serve as

  20. Relation Between Dose of Loop Diuretics and Outcomes in a Heart Failure Population: Results of the ESCAPE Trial

    Science.gov (United States)

    Hasselblad, Vic; Stough, Wendy Gattis; Shah, Monica R.; Lokhnygina, Yuliya; O’Connor, Christopher M.; Califf, Robert M.; Adams, Kirkwood F.

    2007-01-01

    Background We examined the relation of maximal in-hospital diuretic dose to weight loss, changes in renal function, and mortality in hospitalised heart failure (HF) patients. Methods In ESCAPE, 395 patients received diuretics in-hospital. Weight was measured at baseline, discharge, and every other day before discharge. Weight loss was defined as the difference between baseline and last in-hospital weight. Mortality was assessed using a log-logistic model with non-zero background. Results Median weight loss: 2.8 kg (0.7, 6.1); mean: 3.7 kg (22% of values 300 mg/day. Dose remained a significant predictor of mortality after adjusting for baseline variables that significantly predicted mortality. Correlation between maximal dose and creatinine level change was not significant (r = 0.043; p = 0.412) Conclusions High diuretic doses during HF hospitalisation are associated with increased mortality and poor 6-month outcome. PMID:17719273

  1. Midterm Clinical and First Reproductive Results of a Randomized Controlled Trial Comparing Uterine Fibroid Embolization and Myomectomy

    International Nuclear Information System (INIS)

    The purpose of this study was to compare the midterm results of a radiological and surgical approach to uterine fibroids. One hundred twenty-one women with reproductive plans who presented with an intramural fibroid(s) larger than 4 cm were randomly selected for either uterine artery embolization (UAE) or myomectomy. We compared the efficacy and safety of the two procedures and their impact on patient fertility. Fifty-eight embolizations and 63 myomectomies (42 laparoscopic, 21 open) were performed. One hundred eighteen patients have finished at least a 12-month follow-up; the mean follow-up in the entire study population was 24.9 months. Embolized patients underwent a significantly shorter procedure and required a shorter hospital stay and recovery period. They also presented with a lower CRP concentration on the second day after the procedure (p < 0.0001 for all parameters). There were no significant differences between the two groups in the rate of technical success, symptomatic effectiveness, postprocedural follicle stimulating hormone levels, number of reinterventions for fibroid recurrence or regrowth, or complication rates. Forty women after myomectomy and 26 after UAE have tried to conceive, and of these we registered 50 gestations in 45 women. There were more pregnancies (33) and labors (19) and fewer abortions (6) after surgery than after embolization (17 pregnancies, 5 labors, 9 abortions) (p < 0.05). Obstetrical and perinatal results were similar in both groups, possibly due to the low number of labors after UAE to date. We conclude that UAE is less invasive and as symptomatically effective and safe as myomectomy, but myomectomy appears to have superior reproductive outcomes in the first 2 years after treatment

  2. Carotid Stenting with Distal Protection in High-Surgical-Risk Patients: One-Year Results of the ASTI Trial

    Energy Technology Data Exchange (ETDEWEB)

    Bosiers, Marc, E-mail: marc.bosiers@telenet.be [A.Z. Sint-Blasius, Department of Vascular Surgery (Belgium); Scheinert, Dierk, E-mail: dierk.scheinert@gmx.de [Park Hospital, Center for Vascular Medicine-Angiology and Vascular Surgery (Germany); Mathias, Klaus, E-mail: k.mathias@asklepios.com [Klinikum Dortmund GmbH (Germany); Langhoff, Ralf, E-mail: ralf.langhoff@sankt-gertrauden.de [Sankt Gertrauden-Krankenhaus (Germany); Mudra, Harald, E-mail: haraldmudra@aol.com [Klinikum Neuperlach (Germany); Diaz-Cartelle, Juan, E-mail: juan.diazcartelle@bostonscientific.com [One Boston Scientific Place, Boston Scientific Corporation (United States)

    2015-04-15

    PurposeThis prospective, multicenter, nonrandomized study evaluated the periprocedural and 1-year outcomes in high-surgical-risk patients with carotid artery stenosis treated with the Adapt Carotid Stent plus FilterWire EZ distal protection catheter (Boston Scientific Corporation, Natick, MA).Materials and MethodsThe study enrolled 100 patients (32 symptomatic, 63 asymptomatic, 5 unknown) at high risk for carotid endarterectomy due to prespecified anatomical criteria and/or medical comorbidities. Thirty-day and 1-year follow-up included clinical evaluation, carotid duplex ultrasound, and independent neurologic and NIH stroke scale assessments. One-year endpoints included the composite rate of major adverse events (MAE), defined as death, stroke, and myocardial infarction (MI) and the rates of late ipsilateral stroke (31–365 days), target lesion revascularization, and in-stent restenosis.ResultsOf the 100 enrolled patients, technical success was achieved in 90.9 % (90/99). The 30-day MAE rate (5.1 %) consisted of major stroke (2.0 %) and minor stroke (3.1 %); no deaths or MIs occurred. The 1-year MAE rate (12.2 %) consisted of death, MI, and stroke rates of 4.4, 3.3, and 8.9 %, respectively. Late ipsilateral stroke (31–365 days) rate was 1.1 %. Symptomatic patients had higher rates of death (11.1 vs. 1.7 %) and MI (7.4 vs. 1.7 %), but lower rates of major (7.4 vs. 10.0 %) and minor stroke (0.0 vs. 6.7 %), compared with asymptomatic patients.ConclusionResults through 1 year postprocedure demonstrated that carotid artery stenting with Adapt Carotid Stent and FilterWire EZ is safe and effective in high-risk-surgical patients.

  3. Effects of calorie labeling and value size pricing on fast food meal choices: Results from an experimental trial

    Directory of Open Access Journals (Sweden)

    Jeffery Robert W

    2008-12-01

    Full Text Available Abstract Background Although point-of-purchase calorie labeling at restaurants has been proposed as a strategy for improving consumer food choices, a limited number of studies have evaluated this approach. Likewise, little research has been conducted to evaluate the influence of value size pricing on restaurant meal choices. Methods To examine the effect of point-of-purchase calorie information and value size pricing on fast food meal choices a randomized 2 × 2 factorial experiment was conducted in which participants ordered a fast food meal from one of four menus that varied with respect to whether calorie information was provided and whether value size pricing was used. Study participants included 594 adolescents and adults who regularly ate at fast food restaurants. Study staff recorded the foods ordered and consumed by each participant. Participants also completed surveys to assess attitudes, beliefs and practices related to fast food and nutrition. Results No significant differences in the energy composition of meals ordered or eaten were found between menu conditions. The average energy content of meals ordered by those randomized to a menu that included calorie information and did not include value size pricing was 842 kcals compared with 827 kcals for those who ordered their meal from a menu that did not include calorie information but had value size pricing (control menu. Results were similar in most analyses conducted stratified by factors such as age, race and education level. Conclusion Additional research is needed to better evaluate the effects of calorie labeling and value size pricing on fast food meal choices. Studies in which participants are repeatedly exposed to these factors are needed since long term exposure may be required for behavior change.

  4. Metabolic effects of lifestyle intervention in obese pregnant women. Results from the randomized controlled trial 'Lifestyle in Pregnancy' (LiP)

    DEFF Research Database (Denmark)

    Vinter, C A; Jørgensen, J S; Ovesen, Per Glud;

    2014-01-01

    AIMS: The Lifestyle in Pregnancy intervention in obese pregnant women resulted in significantly lower gestational weight gain compared with the control group, but without improvement in rates of clinical pregnancy complications. The impact of the lifestyle intervention on metabolic measurements...... in the study participants is now reported. METHODS: The Lifestyle in Pregnancy study was a randomized controlled trial among 360 obese women (BMI 30-45 kg/m(2) ) who were allocated in early pregnancy to lifestyle interventions with diet counselling and physical activities or to the control group. Fasting blood...... weight gain in the intervention group, there was no difference between the groups with respect to total cholesterol, HDL, LDL or triglycerides. CONCLUSIONS: Lifestyle intervention in obese pregnant women resulted in attenuation of the physiologic pregnancy-induced insulin resistance. Despite restricted...

  5. Robustness of the healthcare utilization results from the Rotavirus Efficacy and Safety Trial (REST evaluating the human-bovine (WC3 reassortant pentavalent rotavirus vaccine (RV5

    Directory of Open Access Journals (Sweden)

    Van Damme Pierre

    2010-06-01

    Full Text Available Abstract Background The Rotavirus Efficacy and Safety Trial was a placebo-controlled Phase III study that evaluated the safety and efficacy of a three-dose pentavalent rotavirus vaccine (RV5 including its effect on healthcare utilization for rotavirus gastroenteritis (RVGE. The per-protocol (PP analyses, which counted events occurring 14 days after dose 3 among infants without protocol violations, have already been published. This paper evaluates the consistency of the healthcare utilization results based on the modified intention to treat (MITT analyses with the PP analyses. The MITT analyses include all infants receiving at least one dose of vaccine or placebo and follow-up begins after dose 1. The paper also explores the consistency of the results for different subgroups of the study population with different types of surveillance. Methods Data on healthcare utilization for acute gastroenteritis were collected via telephone interviews after administration of the first dose. Parents were either contacted every 6 weeks or every 2 weeks depending on the substudy in which they were enrolled. Those contacted every 2 weeks were also asked to complete symptom diaries. Poisson regression was used to evaluate the effect of RV5 on the rates of RVGE-associated healthcare encounters in all of the analyses. Results In the first 2 years after vaccination, RV5 reduced the combined rate of hospitalizations and emergency department (ED visits 88.9% (95% CI: 84.9, 91.9 for all RVGE regardless of serotype in the MITT analysis compared with a 94.5% (95% CI: 91.2, 96.6 reduction based on the G1-G4 PP analysis. By type of surveillance, the rate reductions for the G1-G4 PP analysis were 91.0% (95% CI: 81.7, 95.5 and 95.9% (95% CI: 92.2, 97.8 among parents contacted every 2 weeks (number evaluable = 4,451 and every 6 weeks (number evaluable = 52,683 respectively. Conclusions Our analyses demonstrated that the effect of RV5 on reducing the rate of hospitalizations

  6. Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Patients Receiving Breast Radiation Therapy: Results of a Randomized Trial

    International Nuclear Information System (INIS)

    Purpose: We wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study (Boström et al, Radiother Oncol 2001;59:257-265). Methods and Materials: The study was a double-blind comparison of MF with D (Diprobase), administered daily from the start of radiation therapy for 5 weeks in patients receiving breast radiation therapy, 40 Gy in 2.67-Gy fractions daily over 3 weeks. The primary endpoint was mean modified Radiation Therapy Oncology Group (RTOG) score. Results: Mean RTOG scores were significantly less for MF than for D (P=.046). Maximum RTOG and mean erythema scores were significantly less for MF than for D (P=.018 and P=.012, respectively). The Dermatology Life Quality Index (DLQI) score was significantly less for MF than for D at weeks 4 and 5 when corrected for Hospital Anxiety and Depression (HAD) questionnaire scores. Conclusions: MF cream significantly reduces radiation dermatitis when applied to the breast during and after radiation therapy. For the first time, we have shown a significantly beneficial effect on quality of life using a validated instrument (DLQI), for a topical steroid cream. We believe that application of this cream should be the standard of care where radiation dermatitis is expected

  7. Is Roux-Y Binding Pancreaticojejunal Anastomosis Feasible for Patients Undergoing Left Pancreatectomy? Results from a Prospective Randomized Trial

    Directory of Open Access Journals (Sweden)

    Anne Antila

    2014-01-01

    Full Text Available Background. After pancreaticoduodenectomy, the Finnish binding pancreaticojejunal anastomosis (FBPJ seems to reduce the risk for pancreatic fistula (POPF. Our aim was to investigate whether FBPJ is feasible and prevents the risk for POPF even after left pancreatectomy (LP. Patients and Methods. 47 consecutive patients underwent LP. 27 patients were recruited on the basis of CT and, of these, 16 patients were randomized on the basis of findings during surgery (transection line must be left of portal vein, as 2-3 cm pancreatic mobilization is required for FBPJ to receive either Roux-Y FBPJ or hand-sewn closure of the pancreatic remnant. Results. Only 34% (16/47 of the patients met the randomization criteria. Clinically significant POPF rate was higher in FBPJ group (60% compared to thand-sewn closure group (13%; P<0.05. POPF rate in FBPJ group was higher even when compared to all patients with hand-sewn closure (60% versus 37%; P<0.05. Overall, FBPJ was technically feasible for only 28% of patients. Conclusion. FBPJ cannot be recommended for the routine closure of the pancreatic remnant after LP, as it was not technically achievable in 72% of the cases. Moreover, the technique does not seem to reduce the risk for POPF compared to the hand-sewn closure.

  8. New test principle for measurement of free thyroxine (fT/sub 4/) in serum. Results of a multicenter trial

    Energy Technology Data Exchange (ETDEWEB)

    Mahlstedt, J.

    1981-04-01

    A new principle for measurement of free serum thyroxine was investigated being a nearly classical radioimmunoassay by use of an analogue of /sup 125/I-T/sub 4/, which does not bind to serum proteins but binds as well as T/sub 4/ to the T/sub 4/-antiserum. The distribution of 438 test-results of euthyroid patients with and without goitre is normal, anti x being 1.34 ng/dl with 2s-range between 0.73-1.95 ng/dl. This normal range was derived from areas in FRG known for more or less iodine deficiency. Thus fT/sub 4/ seems not to be strongly dependent on iodine intake. fT/sub 4/ in sera from pregnant women of the third trimester was clearly decreased, one half of the values being in the lower normal range, the other half being in the hypothyroid range. Patients on contraceptive therapy showed values within the normal range. Patients on T/sub 4/-supplementation in part revealed more or less increased values. Quality control was performed using 44 assays. The mean interassay variation coefficient was clearly less than 10% using three control sera in the euthyroid, hyperthyroid and extremely hypothyroid range. The technical handling of the assay is very convenient. The assay is to be performed within 2 hours.

  9. Mometasone Furoate Cream Reduces Acute Radiation Dermatitis in Patients Receiving Breast Radiation Therapy: Results of a Randomized Trial

    Energy Technology Data Exchange (ETDEWEB)

    Hindley, Andrew, E-mail: andrew.hindley@lthtr.nhs.uk [Rosemere Cancer Centre, Royal Preston Hospital, Preston (United Kingdom); Zain, Zakiyah [College of Arts and Sciences, Universiti Utara Malaysia, Kedah (Malaysia); Wood, Lisa [Department of Social Sciences, Lancaster Medical School, Lancaster (United Kingdom); Whitehead, Anne [Medical and Pharmaceutical Statistics Research Unit, Lancaster University, Lancaster (United Kingdom); Sanneh, Alison; Barber, David; Hornsby, Ruth [Rosemere Cancer Centre, Royal Preston Hospital, Preston (United Kingdom)

    2014-11-15

    Purpose: We wanted to confirm the benefit of mometasone furoate (MF) in preventing acute radiation reactions, as shown in a previous study (Boström et al, Radiother Oncol 2001;59:257-265). Methods and Materials: The study was a double-blind comparison of MF with D (Diprobase), administered daily from the start of radiation therapy for 5 weeks in patients receiving breast radiation therapy, 40 Gy in 2.67-Gy fractions daily over 3 weeks. The primary endpoint was mean modified Radiation Therapy Oncology Group (RTOG) score. Results: Mean RTOG scores were significantly less for MF than for D (P=.046). Maximum RTOG and mean erythema scores were significantly less for MF than for D (P=.018 and P=.012, respectively). The Dermatology Life Quality Index (DLQI) score was significantly less for MF than for D at weeks 4 and 5 when corrected for Hospital Anxiety and Depression (HAD) questionnaire scores. Conclusions: MF cream significantly reduces radiation dermatitis when applied to the breast during and after radiation therapy. For the first time, we have shown a significantly beneficial effect on quality of life using a validated instrument (DLQI), for a topical steroid cream. We believe that application of this cream should be the standard of care where radiation dermatitis is expected.

  10. Recent Advances and Field Trial Results Integrating Cosmic Ray Muon Tomography with Other Data Sources for Mineral Exploration

    Science.gov (United States)

    Schouten, D.

    2015-12-01

    CRM GeoTomography Technologies, Inc. is leading the way in applying muon tomography to discovery and definition of dense ore bodies for mineral exploration and resource estimation. We have successfully imaged volcanogenic massive sulfide (VMS) deposits at mines in North America using our suite of field-proven muon tracking detectors, and are at various stages of development for other applications. Recently we developed in-house inversion software that integrates data from assays, surface and borehole gravity, and underground muon flux measurements. We have found that the differing geophysical data sources provide complementary information and that dramatic improvements in inversion results are attained using various inversion performance metrics related to the excess tonnage of the mineral deposits, as well as their spatial extents and locations. This presentation will outline field tests of muon tomography performed by CRM Geotomography in some real world examples, and will demonstrate the effectiveness of joint muon tomography, assay and gravity inversion techniques in field tests (where data are available) and in simulations.

  11. Appropriate Osteoporosis Treatment by Family Physicians in Response to FRAX vs CAROC Reporting: Results From a Randomized Controlled Trial

    Science.gov (United States)

    Beattie, Karen A.; Ioannidis, George; MacDermid, Joy C.; Grewal, Ruby; Papaioannou, Alexandra; Adachi, Jonathan D.; Hodsman, Anthony B.

    2016-01-01

    Canadian guidelines recommend either the FRAX or the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) fracture risk assessment tools to report 10-yr fracture risk as low (20%). It is unknown whether one reporting system is more effective in helping family physicians (FPs) identify individuals who require treatment. Individuals ≥50 yr old with a distal radius fracture and no previous osteoporosis diagnosis or treatment were recruited. Participants underwent a dual-energy x-ray absorptiometry scan and answered questions about fracture risk factors. Participants’ FPs were randomized to receive either a FRAX report or the standard CAROC-derived bone mineral density report currently used by the institution. Only the FRAX report included statements regarding treatment recommendations. Within 3 mo, all participants were asked about follow-up care by their FP, and treatment recommendations were compared with an osteoporosis specialist. Sixty participants were enrolled (31 to FRAX and 29 to CAROC). Kappa statistics of agreement in treatment recommendation were 0.64 for FRAX and 0.32 for bone mineral density. The FRAX report was preferred by FPs and resulted in better postfracture follow-up and treatment that agreed more closely with a specialist. Either the clear statement of fracture risk or the specific statement of treatment recommendations on the FRAX report may have supported FPs to make better treatment decisions. PMID:24206869

  12. Cognitive-Behavioral Treatment of Posttraumatic Stress in Patients With Implantable Cardioverter Defibrillators: Results From a Randomized Controlled Trial.

    Science.gov (United States)

    Ford, Jessica; Rosman, Lindsey; Wuensch, Karl; Irvine, Jane; Sears, Samuel F

    2016-08-01

    Approximately 20% of patients with implantable cardioverter defibrillators (ICDs) suffer from posttraumatic stress disorder (PTSD) due to a history of cardiac arrest, device implantation, and ICD shock. There has been very little examination of treatment of PTSD symptoms in these patients. This study evaluated the effect of a specific cognitive-behavioral therapy (CBT) intervention for ICD patients with high levels of PTSD symptoms: a manualized program consisting of 8 telephone sessions with a trained counselor, a patient education book, and a stress management procedure on compact disc. Participants were 193 ICD patients, who were randomized to CBT or usual cardiac care (UCC) who completed self-report surveys at the time of recruitment and 6 and 12 months after initial measurement. Previous publication on the primary research evaluation questions reported that the CBT condition resulted in greater improvement on PTSD and depression symptoms than the UCC for the general population of ICD patients, but did not evaluate the effect on those with elevated symptoms of PTSD. The authors conducted secondary analyses of the effect of treatment on high and low PTSD symptom groups based on a cutoff for the Impact of Event Scale-Revised (Weiss & Marmar, 1997). Participants in the CBT group who had high symptoms experienced significantly greater symptom reduction from baseline to 12 months (d = 2.44, p = .021) than the UCC group (d = 1.12). Participants with low symptoms had small reductions regardless of group assignment (d = 0.16, p = .031). ICD-focused CBT was sufficient to produce a large, statistically significant reduction in PTSD symptoms in ICD patients with indications for treatment.

  13. Cognitive-Behavioral Treatment of Posttraumatic Stress in Patients With Implantable Cardioverter Defibrillators: Results From a Randomized Controlled Trial.

    Science.gov (United States)

    Ford, Jessica; Rosman, Lindsey; Wuensch, Karl; Irvine, Jane; Sears, Samuel F

    2016-08-01

    Approximately 20% of patients with implantable cardioverter defibrillators (ICDs) suffer from posttraumatic stress disorder (PTSD) due to a history of cardiac arrest, device implantation, and ICD shock. There has been very little examination of treatment of PTSD symptoms in these patients. This study evaluated the effect of a specific cognitive-behavioral therapy (CBT) intervention for ICD patients with high levels of PTSD symptoms: a manualized program consisting of 8 telephone sessions with a trained counselor, a patient education book, and a stress management procedure on compact disc. Participants were 193 ICD patients, who were randomized to CBT or usual cardiac care (UCC) who completed self-report surveys at the time of recruitment and 6 and 12 months after initial measurement. Previous publication on the primary research evaluation questions reported that the CBT condition resulted in greater improvement on PTSD and depression symptoms than the UCC for the general population of ICD patients, but did not evaluate the effect on those with elevated symptoms of PTSD. The authors conducted secondary analyses of the effect of treatment on high and low PTSD symptom groups based on a cutoff for the Impact of Event Scale-Revised (Weiss & Marmar, 1997). Participants in the CBT group who had high symptoms experienced significantly greater symptom reduction from baseline to 12 months (d = 2.44, p = .021) than the UCC group (d = 1.12). Participants with low symptoms had small reductions regardless of group assignment (d = 0.16, p = .031). ICD-focused CBT was sufficient to produce a large, statistically significant reduction in PTSD symptoms in ICD patients with indications for treatment. PMID:27415850

  14. Biochar mineralization and priming effect on SOM decomposition. Results from a field trial in a short rotation coppice in Italy

    Science.gov (United States)

    Ventura, Maurizio; Alberti, Giorgio; Panzacchi, Pietro; Delle Vedove, Gemini; Miglietta, Franco; Tonon, Giustino

    2016-04-01

    Biochar application to soil has been proposed as a promising strategy for carbon (C) sequestration and climate change mitigation, helping at the same time to maintain soil fertility. However, most of the knowledge on biochar stability is based on short-term lab incubation experiments, as field studies are scarce. Therefore, little is known about the interactions between biochar and roots and the related effects on biochar stability in field conditions. The present study aimed to assess the stability of biochar, its effect on original soil organic matter (SOM) decomposition, and the effect of plant roots on biochar stability in field conditions in Northern Italy, for a three-year monitoring period within the EuroChar project. The experiment was conducted in a poplar short rotation coppice (SRC). Biochar produced from maize (δ13C = -13.8‰) silage pellets in a gasification plant was applied in a poplar short rotation coppice (SRC) plantation in Northern Italy. Root exclusion subplots were established using the trenching method to measure heterotrophic respiration. Total (Rtot) and heterotrophic (Rh) respiration were measured every 2 hours in control and biochar-treated soil, with a closed dynamic soil respiration system. δ13C of the soil-emited CO2 was periodically measured using the Keeling plot method. The percentage of biochar-derived soil respiration (fB), was calculated using an isotopic mass balance. Results showed that fB varied between 7% and 37% according to the sampling date, and was generally higher in the presence of roots than in trenched plots where the root growth was excluded. Without roots, only the 14% of the carbon originally added with biochar was decomposed. In the presence of roots, this percentage increased to 21%, suggesting a positive priming effect of roots on biochar decomposition. On the other hand, biochar decreased the decomposition of original SOM by about 17%, suggesting a protective effect of biochar on SOM.

  15. Ten-Year Survival Results of a Randomized Trial of Irradiation of Internal Mammary Nodes After Mastectomy

    Energy Technology Data Exchange (ETDEWEB)

    Hennequin, Christophe, E-mail: christophe.hennequin@sls.aphp.fr [Hôpital Saint-Louis, AP-HP et Université de Paris VII (France); Bossard, Nadine [Hospices Civils de Lyon, Service de Biostatistique, Université Lyon 1, Lyon, and CNRS, UMR5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biotatistique-Santé, Villeurbanne (France); Servagi-Vernat, Stéphanie [Centre hospitalier Universitaire de Besançon (France); Maingon, Philippe [Centre François Leclerc, Dijon (France); Dubois, Jean-Bernard [Centre Val d' Aurelle, Montpellier (France); Datchary, Jean [Centre Hospitalier d' Annecy (France); Carrie, Christian [Centre Léon Bérard, Lyon (France); Roullet, Bernard [Centre Hospitalier Universitaire de Limoges (France); Suchaud, Jean-Philippe [Centre Hospitalier de Roanne (France); Teissier, Eric [Centre de Radiothérapie de Mougins (France); Lucardi, Audrey [Hospices Civils de Lyon (France); Gerard, Jean-Pierre [Centre Antoine Lacassagne, Nice (France); Belot, Aurélien [Hospices Civils de Lyon, Service de Biostatistique, Université Lyon 1, Lyon, and CNRS, UMR5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biotatistique-Santé, Villeurbanne (France); Institut de Veille Sanitaire, Département des Maladies Chroniques et des Traumatismes, Saint-Maurice (France); and others

    2013-08-01

    Purpose: To evaluate the efficacy of irradiation of internal mammary nodes (IMN) on 10-year overall survival in breast cancer patients after mastectomy. Methods and Patients: This multicenter phase 3 study enrolled patients with positive axillary nodes (pN+) or central/medial tumors with or without pN+. Other inclusion criteria were age <75 and a Karnofsky index ≥70. All patients received postoperative irradiation of the chest wall and supraclavicular nodes and were randomly assigned to receive IMN irradiation or not. Randomization was stratified by tumor location (medial/central or lateral), axillary lymph node status, and adjuvant therapy (chemotherapy vs no chemotherapy). The prescribed dose of irradiation to the target volumes was 50 Gy or equivalent. The first 5 intercostal spaces were included in the IMN target volume, and two-thirds of the dose (31.5 Gy) was given by electrons. The primary outcome was overall survival at 10 years. Disease-free survival and toxicity were secondary outcomes. Results: T total of 1334 patients were analyzed after a median follow-up of 11.3 years among the survivors. No benefit of IMN irradiation on the overall survival could be demonstrated: the 10-year overall survival was 59.3% in the IMN-nonirradiated group versus 62.6% in the IMN-irradiated group (P=.8). According to stratification factors, we defined 6 subgroups (medial/central or lateral tumor, pN0 [only for medial/central] or pN+, and chemotherapy or not). In all these subgroups, IMN irradiation did not significantly improve overall survival. Conclusions: In patients treated with 2-dimensional techniques, we failed to demonstrate a survival benefit for IMN irradiation. This study cannot rule out a moderate benefit, especially with more modern, conformal techniques applied to a higher risk population.

  16. Efficacy and Safety of Cariprazine in Acute Exacerbation of Schizophrenia: Results From an International, Phase III Clinical Trial.

    Science.gov (United States)

    Kane, John M; Zukin, Stephen; Wang, Yao; Lu, Kaifeng; Ruth, Adam; Nagy, Krisztián; Laszlovszky, István; Durgam, Suresh

    2015-08-01

    This phase III study evaluated the efficacy and safety of cariprazine, a dopamine D3 and D2 receptor partial agonist with preferential binding to D3 receptors, in patients with acute exacerbation of schizophrenia. Patients were randomized to 6-week double-blind treatment with placebo, cariprazine 3 to 6 mg/d, or cariprazine 6 to 9 mg/d. Primary and secondary efficacy: change from baseline to week 6 in Positive and Negative Syndrome Scale total and Clinical Global Impressions-Severity scores, respectively, analyzed using a mixed-effects model for repeated measures adjusting for multiple comparisons. Safety included treatment-emergent adverse events, clinical laboratory values, vital signs, electrocardiograms, ophthalmologic examination, Columbia-Suicide Severity Rating Scale, and extrapyramidal symptom scales. In the Safety Population (placebo, n = 147; cariprazine 3-6 mg/d, n = 151; cariprazine 6-9 mg/d, n = 148), 60.5% of patients completed the study. At week 6, statistically significant least squares mean differences in favor of cariprazine versus placebo were observed for Positive and Negative Syndrome Scale total score (3-6 mg/d: -6.8, P = 0.003; 6-9 mg/d: -9.9, P Global Impressions-Severity (3-6 mg/d: -0.3, P = 0.012; 6-9 mg/d: -0.5, P < 0.001). Common treatment-emergent adverse events (≥5% and twice the rate of placebo) in both cariprazine groups were akathisia, extrapyramidal disorder, and tremor; most were mild to moderate in severity. Mean changes in metabolic parameters were generally small and similar between groups. Prolactin levels decreased in all groups. In conclusion, cariprazine 3 to 6 and 6 to 9 mg/d versus placebo demonstrated significant improvement on primary and secondary efficacy parameters. Cariprazine was generally well tolerated. These results suggest that cariprazine may be a new and effective treatment for schizophrenia. PMID:26075487

  17. The effect of a brief social intervention on the examination results of UK medical students: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Dacre Jane

    2009-06-01

    Full Text Available Abstract Background Ethnic minority (EM medical students and doctors underperform academically, but little evidence exists on how to ameliorate the problem. Psychologists Cohen et al. recently demonstrated that a written self-affirmation intervention substantially improved EM adolescents' school grades several months later. Cohen et al.'s methods were replicated in the different setting of UK undergraduate medical education. Methods All 348 Year 3 white (W and EM students at one UK medical school were randomly allocated to an intervention condition (writing about one's own values or a control condition (writing about another's values, via their tutor group. Students and assessors were blind to the existence of the study. Group comparisons on post-intervention written and OSCE (clinical assessment scores adjusted for baseline written assessment scores were made using two-way analysis of covariance. All assessment scores were transformed to z-scores (mean = 0 standard deviation = 1 for ease of comparison. Comparisons between types of words used in essays were calculated using t-tests. The study was covered by University Ethics Committee guidelines. Results Groups were statistically identical at baseline on demographic and psychological factors, and analysis was by intention to treat [intervention group EM n = 95, W n = 79; control group EM n = 77; W n = 84]. As predicted, there was a significant ethnicity by intervention interaction [F(4,334 = 5.74; p = 0.017] on the written assessment. Unexpectedly, this was due to decreased scores in the W intervention group [mean difference = 0.283; (95% CI = 0.093 to 0.474] not improved EM intervention group scores [mean difference = -0.060 (95% CI = -0.268 to 0.148]. On the OSCE, both W and EM intervention groups outperformed controls [mean difference = 0.261; (95%CI = -0.047 to -0.476; p = 0.013]. The intervention group used more optimistic words (p Discussion Cohen et al.'s finding that a brief self

  18. Patient reported outcome measures (PROMs) following forward planned field-in field IMRT: Results from the Cambridge Breast IMRT trial

    International Nuclear Information System (INIS)

    Background: The use of intensity-modulated radiotherapy (IMRT) in breast cancer reduces clinician-assessed breast tissue toxicity including fibrosis, telangectasia and sub-optimal cosmesis. Patient reported outcome measures (PROMs) are also important as they provide the patient’s perspective. This longitudinal study reports on (a) the effect of forward planned field-in-field IMRT (∼simple IMRT) on PROMs compared to standard RT at 5 years after RT, (b) factors affecting PROMs at 5 years after RT and (c) the trend of PROMs over 5 years of follow up. Methods: PROMs were assessed at baseline (pre-RT), 6, 24 and 60 months after completion of RT using global health (EORTC QLQ C30) and 4 breast symptom questions (BR23). Also, 4 breast RT-specific questions were included at 6, 24 and 60 months: change in skin appearance, firmness to touch, reduction in breast size and overall change in breast appearance since RT. The benefits of simple IMRT over standard RT at 5 years after RT were assessed using standard t-test for global health and logistic regression analysis for breast symptom questions and breast RT-specific questions. Clinical factors affecting PROMs at 5 years were investigated using a multivariate analysis. A repeated mixed model was applied to explore the trend over time for each of PROMs. Results: (89%) 727/815, 84%, 81% and 61% patients completed questionnaires at baseline, 6, 24 and 60 months respectively. Patients reported worse toxicity for all four BR23 breast symptoms at 6 months, which then improved over time (p < 0.0001). They also reported improvement in skin appearance and breast hardness over time (p < 0.0001), with no significant change for breast shrinkage (p = 0.47) and overall breast appearance (p = 0.13). At 5 years, PROMs assessments did not demonstrate a benefit for simple IMRT over standard radiotherapy. Large breast volume, young age, baseline surgical cosmesis and post-operative infection were the most important variables to affect PROMs

  19. Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial

    Directory of Open Access Journals (Sweden)

    Fong R

    2012-07-01

    Full Text Available Raymond Fong,1 Martin Leitritz,2 Raphaele Siou-Mermet,3 Tara Erb41Manhattan Eye, Ear and Throat Hospital, Lenox Hill Hospital, New York, NY, USA; 2Department of Ophthalmology, University Eye Hospital Tübingen, University of Tübingen, Tübingen, Germany; 3Bausch and Lomb, Montpellier, France; 4Bausch and Lomb, Rochester, NY, USAPurpose: Loteprednol etabonate (LE is approved by the US FDA in a suspension and ointment form (0.5% for the treatment of postoperative ocular inflammation. This study examined the gel formulation of LE, an improved, nonsettling formulation with a lower preservative level and a more physiologic pH.Patients and methods: This multicenter, double-masked, parallel-group, vehicle-controlled study randomized patients aged ≥18 years with postoperative anterior chamber cell (ACC ≥ grade 2 following uncomplicated cataract surgery to either LE gel or vehicle four times a day for 14 days. Primary efficacy end points included the proportion of patients with complete resolution of ACC and grade 0 (no pain by postoperative day 8. Secondary efficacy end points included complete resolution and change from baseline in ACC and flare (individual and combined, and grade 0 pain at each visit. Safety end points included treatment-emergent adverse events, ocular symptoms, changes in intraocular pressure (IOP and visual acuity, and biomicroscopy and funduscopy findings.Results: A total of 407 patients were randomized to treatment (n = 206, LE gel; n = 201, vehicle. At day 8, 31.1% (64 of LE-treated patients and 13.9% (28 of vehicle-treated patients had complete resolution of ACC (P < 0.001, and 75.7% (156 of LE-treated patients and 45.8% (92 of vehicle-treated patients had grade 0 pain (P < 0.001. Secondary efficacy end points also favored LE gel. Fewer patients treated with LE gel required rescue medication (10.7% versus 42.3% prior to day 15, and fewer had an ocular adverse event (16.0% versus 28.9%, P = 0.002. No drug-related adverse

  20. The role of facemasks and hand hygiene in the prevention of influenza transmission in households: results from a cluster randomised trial; Berlin, Germany, 2009-2011

    Directory of Open Access Journals (Sweden)

    Suess Thorsten

    2012-01-01

    Full Text Available Abstract Background Previous controlled studies on the effect of non-pharmaceutical interventions (NPI - namely the use of facemasks and intensified hand hygiene - in preventing household transmission of influenza have not produced definitive results. We aimed to investigate efficacy, acceptability, and tolerability of NPI in households with influenza index patients. Methods We conducted a cluster randomized controlled trial during the pandemic season 2009/10 and the ensuing influenza season 2010/11. We included households with an influenza positive index case in the absence of further respiratory illness within the preceding 14 days. Study arms were wearing a facemask and practicing intensified hand hygiene (MH group, wearing facemasks only (M group and none of the two (control group. Main outcome measure was laboratory confirmed influenza infection in a household contact. We used daily questionnaires to examine adherence and tolerability of the interventions. Results We recruited 84 households (30 control, 26 M and 28 MH households with 82, 69 and 67 household contacts, respectively. In 2009/10 all 41 index cases had a influenza A (H1N1 pdm09 infection, in 2010/11 24 had an A (H1N1 pdm09 and 20 had a B infection. The total secondary attack rate was 16% (35/218. In intention-to-treat analysis there was no statistically significant effect of the M and MH interventions on secondary infections. When analysing only households where intervention was implemented within 36 h after symptom onset of the index case, secondary infection in the pooled M and MH groups was significantly lower compared to the control group (adjusted odds ratio 0.16, 95% CI, 0.03-0.92. In a per-protocol analysis odds ratios were significantly reduced among participants of the M group (adjusted odds ratio, 0.30, 95% CI, 0.10-0.94. With the exception of MH index cases in 2010/11 adherence was good for adults and children, contacts and index cases. Conclusions Results suggest

  1. Pharmacokinetic and pharmacodynamic studies of two different rabbit antithymocyte globulin dosing regimens: results of a randomized trial.

    Science.gov (United States)

    Büchler, Matthias; Longuet, Hélène; Lemoine, Roxane; Herr, Florence; Gatault, Philippe; Thibault, Gilles; Ternant, David; Foulon, Christine; Pilorge, Bernadette; Lemay, Djamila; Sung, Crystal; Halimi, Jean-Michel; Baron, Christophe; Lebranchu, Yvon

    2013-03-01

    Rabbit antithymocyte globulin (rATG; Thymoglobulin(®)) is currently used to prevent acute rejection in kidney transplantation. The dose and regimen of rATG have not been optimized. Moreover, the impact of different treatment regimens on T-cell phenotype reconstitution remains unknown. We conducted a prospective randomized study of 17 renal transplant patients to determine the pharmacokinetics of total and active (bound to human cells) rATG and T-cell phenotype reconstitution after rATG administration. Patients received rATG at a total dose of 6mg/kg, administered either as 1.5mg/kg/day on days 0-3 (Group 1, n=8) or 3mg/kg on days 0 and 3 (Group 2, n=9). All patients received tacrolimus, mycophenolate mofetil and steroids. Blood samples were assayed for total rATG by enzyme linked immunosorbent assay and active rATG by flow cytometry. Maximum concentrations and terminal half-lives were similar between the two groups but at month 3 Group 1 had significantly lower values for total rATG (concentration was 6.2±1.1μg/mL versus 10.2±2.9μg/mL in Group 2, p=0.027) and total rATG dose-normalized AUC (374±83dayg/mL versus 508±149dayg/mL in Group 2, p=0.046). Time to sub-therapeutic levels (<1μg/mL) of active rATG was significantly shorter in Group 1 (18.75±6.9days versus 20±7.5days in Group 2, p<0.001). rATG induced significant depletion followed by slow reconstitution of CD3(+), CD4(+) and CD8(+) cells, with no marked differences between groups. B-cell count was unaffected, whereas CD3(-)CD56(+) NK-cell depletion was observed in both groups. rATG induced a significant decrease in the proportion of naïve CD4(+) T-cells, which plateaued after month 1 in Group 1 and after month 6 in Group 2. The proportion of central memory CD4(+) T-cells increased to a similar extent in both groups (Group 1: 38±18% at baseline, 74±23% at one year, p=0.009; Group 2: 32±14% at baseline, 65±14% at one year, p=0.001). In conclusion, our results suggest that the dosing regimen for r

  2. Randomized trial comparing liposomal daunorubicin with idarubicin as induction for pediatric acute myeloid leukemia: results from Study AML-BFM 2004.

    Science.gov (United States)

    Creutzig, Ursula; Zimmermann, Martin; Bourquin, Jean-Pierre; Dworzak, Michael N; Fleischhack, Gudrun; Graf, Norbert; Klingebiel, Thomas; Kremens, Bernhard; Lehrnbecher, Thomas; von Neuhoff, Christine; Ritter, Jörg; Sander, Annette; Schrauder, André; von Stackelberg, Arend; Starý, Jan; Reinhardt, Dirk

    2013-07-01

    Outcomes of patients with acute myeloid leukemia (AML) improve significantly by intensification of induction. To further intensify anthracycline dosage without increasing cardiotoxicity, we compared potentially less cardiotoxic liposomal daunorubicin (L-DNR) to idarubicin at a higher-than-equivalent dose (80 vs 12 mg/m(2) per day for 3 days) during induction. In the multicenter therapy-optimization trial AML-BFM 2004, 521 of 611 pediatric patients (85%) were randomly assigned to L-DNR or idarubicin induction. Five-year results in both treatment arms were similar (overall survival 76% ± 3% [L-DNR] vs 75% ± 3% [idarubicin], Plogrank = .65; event-free survival [EFS] 59% ± 3% vs 53% ± 3%, Plogrank = .25; cumulative incidence of relapse 29% ± 3% vs 31% ± 3%, P(Gray) = .75), as were EFS results for standard (72% ± 5% vs 68% ± 5%, Plogrank = .47) and high-risk (51% ± 4% vs 46% ± 4%, Plogrank = .45) patients. L-DNR resulted in significantly better probability of EFS in patients with t(8;21). Overall, treatment-related mortality was lower with L-DNR than idarubicin (2/257 vs 10/264 patients, P = .04). Grade 3/4 cardiotoxicity was rare after induction (4 L-DNR vs 5 idarubicin). Only 1 L-DNR and 3 idarubicin patients presented with subclinical or mild cardiomyopathy during follow-up. In conclusion, at the given dose, L-DNR has overall antileukemic activity comparable to idarubicin, promises to be more active in subgroups, and causes less treatment-related mortality. This trial was registered at www.clinicaltrials.gov as #NCT00111345. PMID:23704089

  3. Results 3 decades after the plantation trials with palebark pine in the mountain of the coastal chain in Calabria

    Directory of Open Access Journals (Sweden)

    Silvano Avolio

    2010-12-01

    comparison among the species. The statistical analysis was applied at yrs 1, 12 and 27 from the plantation and concerned the following dependent variables: survival rate, height to diameter ratio, taper ratio. Over the time-intervals 1982-1983, 1982-1994, 1982-2009, results showed: (i the higher survival rate (95.5% and height to diameter ratio at the major elevations and at the wider interplanting distances with plastic bag-grown seedlings; (2 the same system accounted for increasing the taper ratio as compared with the bare-rooted system. Mean diameter is 9.8 cm, mean height is 5.29 m at the age of 27 in the 18 test areas. The first fruiting appeared at the age of 16-18 years. st1\\:*{behavior:url(#ieooui } /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Tabella normale"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman"; mso-ansi-language:#0400; mso-fareast-language:#0400; mso-bidi-language:#0400;} st1\\:*{behavior:url(#ieooui } /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Tabella normale"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman"; mso-ansi-language:#0400; mso-fareast-language:#0400; mso-bidi-language:#0400;}

  4. The effectiveness of physical activity monitoring and distance counseling in an occupational setting – Results from a randomized controlled trial (CoAct

    Directory of Open Access Journals (Sweden)

    Reijonsaari Karita

    2012-05-01

    Full Text Available Abstract Background Lack of physical activity (PA is a known risk factor for many health conditions. The workplace is a setting often used to promote activity and health. We investigated the effectiveness of an intervention on PA and productivity-related outcomes in an occupational setting. Methods We conducted a randomized controlled trial of 12 months duration with two 1:1 allocated parallel groups of insurance company employees. Eligibility criteria included permanent employment and absence of any condition that risked the participant’s health during PA. Subjects in the intervention group monitored their daily PA with an accelerometer, set goals, had access to an online service to help them track their activity levels, and received counseling via telephone or web messages for 12 months. The control group received the results of a fitness test and an information leaflet on PA at the beginning of the study. The intervention’s aim was to increase PA, improve work productivity, and decrease sickness absence. Primary outcomes were PA (measured as MET minutes per week, work productivity (quantity and quality of work; QQ index, and sickness absence (SA days at 12 months. Participants were assigned to groups using block randomization with a computer-generated scheme. The study was not blinded. Results There were 544 randomized participants, of which 521 were included in the analysis (64% female, mean age 43 years. At 12 months, there was no significant difference in physical activity levels between the intervention group (n = 264 and the control group (n = 257. The adjusted mean difference was −206 MET min/week [95% Bayesian credible interval −540 to 128; negative values favor control group]. There was also no significant difference in the QQ index (−0.5 [−4.4 to 3.3] or SA days (0.0 [−1.2 to 0.9]. Of secondary outcomes, body weight (0.5 kg [0.0 to 1.0] and percentage of body fat (0.6% [0.2% to 1.1%] were slightly

  5. Blood pressure normalization in a large population of hypertensive patients treated with perindopril/indapamide combination: results of the OPTIMAX trial

    Directory of Open Access Journals (Sweden)

    Jean-Jacques Mourad

    2007-03-01

    Full Text Available Jean-Jacques Mourad1, Viet Nguyen1, Marilucy Lopez-Sublet1, Bernard Waeber21Dept Internal Medicine and Hypertension Unit, Avicenne hospital-APHP and Paris 13 University, Bobigny, France; 2Bernard Waeber, Division de Physiopathologie Clinique, Lausanne, SwitzerlandObjective: To determine if the fixed-dose perindopril/indapamide combination (Per/Ind normalizes blood pressure (BP in the same fraction of hypertensive patients when treated in everyday practice or in controlled trials.Methods: In this prospective trial, 17 938 hypertensive patients were treated with Per 2 mg/Ind 0.625 mg for 3–6 months. In Group 1 Per/Ind was initiated in newly diagnosed patients (n = 7032; in Group 2 Per/Ind replaced previous therapy in patients already treated but having either their BP still uncontrolled or experiencing side-effects (n = 7423; in Group 3 Per/Ind was added to previous treatment in patients with persistently high BP (n = 3483. BP was considered normalized when ≤ 140/90 mm Hg. A multivariate analysis for predictors of BP normalization was performed.Results: Subjects were on average 62 years old and had a baseline BP of 162.3/93.6 mm Hg. After treatment with Per/Ind, BP normalization was reached in 69.6% of patients in the Initiation group, 67.5% in the Replacement Group, and 67.4% in the Add-on Group (where patients were more frequently at risk, diabetic, or with target organ damage. Mean decreases in systolic BP of 22.8 mm Hg and in diastolic BP of 12.4 mm Hg were recorded. Conclusions: This trial was established to reflect everyday clinical practice, and a treatment strategy based on the Per/Ind combination, administered as initial, replacement, or add-on therapy, led to normalization rates that were superior to those observed in Europe in routine practice. These results support recent hypertension guidelines which encourage the use of combination therapy in the management of arterial hypertension.Keywords: perindopril, indapamide, blood

  6. Physical exercise as a supplement to outpatient treatment of alcohol use disorders – design and preliminary results of a randomized controlled trial

    DEFF Research Database (Denmark)

    Sari, Sengül; Bilberg, Randi Marie; Roessler, Kirsten Kaya

    Background and aim Alcohol use disorder is a widespread problem in Denmark and has severe impacts on health and quality of life of each individual. The clinical treatment of alcohol use disorder involves evidence-based knowledge on medical treatment, physical training, and psychological management....... The aim of this study is to investigate the effect of physical exercise on alcohol intake, cardio-respiratory fitness and socio-psychological outcomes. Methods and design The study is a randomized controlled trial with three arms: (A) Standard treatment alone, (B) Standard treatment and physical exercise...... the study and inform about the first preliminary results. Perspectives If this study detects a positive relationship between exercise as a supplement to alcohol treatment and patients’ alcohol intake, quality of life, fitness, well-being, anxiety, depression and interpersonal problems...

  7. Cognitive-behavioral conjoint therapy for PTSD improves various PTSD symptoms and trauma-related cognitions: Results from a randomized controlled trial.

    Science.gov (United States)

    Macdonald, Alexandra; Pukay-Martin, Nicole D; Wagner, Anne C; Fredman, Steffany J; Monson, Candice M

    2016-02-01

    Numerous studies document an association between posttraumatic stress disorder (PTSD) and impairments in intimate relationship functioning, and there is evidence that PTSD symptoms and associated impairments are improved by cognitive-behavioral conjoint therapy for PTSD (CBCT for PTSD; Monson & Fredman, 2012). The present study investigated changes across treatment in clinician-rated PTSD symptom clusters and patient-rated trauma-related cognitions in a randomized controlled trial comparing CBCT for PTSD with waitlist in a sample of 40 individuals with PTSD and their partners (N = 40; Monson et al., 2012). Compared with waitlist, patients who received CBCT for PTSD immediately demonstrated greater improvements in all PTSD symptom clusters, trauma-related beliefs, and guilt cognitions (Hedge's gs -.33 to -1.51). Results suggest that CBCT for PTSD improves all PTSD symptom clusters and trauma-related cognitions among individuals with PTSD and further supports the value of utilizing a couple-based approach to the treatment of PTSD.

  8. HPTN 068: A Randomized Control Trial of a Conditional Cash Transfer to Reduce HIV Infection in Young Women in South Africa-Study Design and Baseline Results.

    Science.gov (United States)

    Pettifor, Audrey; MacPhail, Catherine; Selin, Amanda; Gómez-Olivé, F Xavier; Rosenberg, Molly; Wagner, Ryan G; Mabuza, Wonderful; Hughes, James P; Suchindran, Chirayath; Piwowar-Manning, Estelle; Wang, Jing; Twine, Rhian; Daniel, Tamu; Andrew, Philip; Laeyendecker, Oliver; Agyei, Yaw; Tollman, Stephen; Kahn, Kathleen

    2016-09-01

    Young women in South Africa are at high risk for HIV infection. Cash transfers offer promise to reduce HIV risk. We present the design and baseline results from HPTN 068, a phase III, individually randomized trial to assess the effect of a conditional cash transfer on HIV acquisition among South African young women. A total of 2533 young women were randomized to receive a monthly cash transfer conditional on school attendance or to a control group. A number of individual-, partner-, household- and school-level factors were associated with HIV and HSV-2 infection. After adjusting for age, all levels were associated with an increased odds of HIV infection with partner-level factors conveying the strongest association (aOR 3.05 95 % CI 1.84-5.06). Interventions like cash transfers that address structural factors such as schooling and poverty have the potential to reduce HIV risk in young women in South Africa. PMID:26891839

  9. NGS-based BRCA1/2 mutation testing of high-grade serous ovarian cancer tissue: results and conclusions of the first international round robin trial.

    Science.gov (United States)

    Endris, Volker; Stenzinger, Albrecht; Pfarr, Nicole; Penzel, Roland; Möbs, Markus; Lenze, Dido; Darb-Esfahani, Silvia; Hummel, Michael; Sabine-Merkelbach-Bruse; Jung, Andreas; Lehmann, Ulrich; Kreipe, Hans; Kirchner, Thomas; Büttner, Reinhard; Jochum, Wolfram; Höfler, Gerald; Dietel, Manfred; Weichert, Wilko; Schirmacher, Peter

    2016-06-01

    With the approval of olaparib as monotherapy treatment in platinum-sensitive, relapsed high-grade serous ovarian cancer by the European Medical Agency (EMA), comprehensive genotyping of BRCA1 and BRCA2 in tumor tissue has become a mandatory pre-therapeutic test. This requires significant advances in routine tumor test methodologies due to the large size of both genes and the lack of mutational hot spots. Classical focused screening approaches, like Sanger sequencing, do not allow for a sensitive, rapid, and economic analysis of tumor tissue. Next-generation sequencing (NGS) approaches employing targeted panels for BRCA1/2 to interrogate formalin-fixed and paraffin-embedded tumor samples from either surgical resection or biopsy specimens can overcome these limitations. Although focused NGS methods have been implemented by few centers in routine molecular diagnostics for the analysis of some druggable oncogenic mutations, the reliable diagnostic testing of the entire coding regions of BRCA1 and BRCA2 was a new challenge requiring extensive technological improvement and quality management. Here, we describe the implementation and results of the first round robin trial for BRCA1/2 mutation testing in tumor tissue that was conducted in central Europe on May 2015, shortly after the approval and prior to the official release of olaparib. The high success rate of 81 % (21/26 test centers) demonstrates that BRCA1/2 multicenter mutation testing is well feasible in FFPE tumor tissue, extending to other tumor entities beyond ovarian cancer. The high number of test centers passing the trial demonstrates the success of the concerted efforts by German, Swiss, and Austrian pathology centers to ensure quality-controlled NGS-based testing and proves the potential of this technology in routine molecular pathology. On the basis of our results, we provide recommendations for predictive testing of tumor tissue for BRCA1/2 to clinical decision making in ovarian cancer patients.

  10. Analysis of Workflow and Time to Treatment and the Effects on Outcome in Endovascular Treatment of Acute Ischemic Stroke: Results from the SWIFT PRIME Randomized Controlled Trial.

    Science.gov (United States)

    Goyal, Mayank; Jadhav, Ashutosh P; Bonafe, Alain; Diener, Hans; Mendes Pereira, Vitor; Levy, Elad; Baxter, Blaise; Jovin, Tudor; Jahan, Reza; Menon, Bijoy K; Saver, Jeffrey L

    2016-06-01

    Purpose To study the relationship between functional independence and time to reperfusion in the Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) trial in patients with disabling acute ischemic stroke who underwent endovascular therapy plus intravenous tissue plasminogen activator (tPA) administration versus tPA administration alone and to investigate variables that affect time spent during discrete steps. Materials and Methods Data were analyzed from the SWIFT PRIME trial, a global, multicenter, prospective study in which outcomes were compared in patients treated with intravenous tPA alone or in combination with the Solitaire device (Covidien, Irvine, Calif). Between December 2012 and November 2014, 196 patients were enrolled. The relation between time from (a) symptom onset to reperfusion and (b) imaging to reperfusion and clinical outcome was analyzed, along with patient and health system characteristics that affect discrete steps in patient workflow. Multivariable logistic regression was used to assess relationships between time and outcome; negative binomial regression was used to evaluate effects on workflow. The institutional review board at each site approved the trial. Patients provided written informed consent, or, at select sites, there was an exception from having to acquire explicit informed consent in emergency circumstances. Results In the stent retriever arm of the study, symptom onset to reperfusion time of 150 minutes led to 91% estimated probability of functional independence, which decreased by 10% over the next hour and by 20% with every subsequent hour of delay. Time from arrival at the emergency department to arterial access was 90 minutes (interquartile range, 69-120 minutes), and time to reperfusion was 129 minutes (interquartile range, 108-169 minutes). Patients who initially arrived at a referring facility had longer symptom onset to groin puncture times compared with

  11. The cost-effectiveness of the RSI QuickScan intervention programme for computer workers: Results of an economic evaluation alongside a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Blatter Birgitte M

    2010-11-01

    Full Text Available Abstract Background The costs of arm, shoulder and neck symptoms are high. In order to decrease these costs employers implement interventions aimed at reducing these symptoms. One frequently used intervention is the RSI QuickScan intervention programme. It establishes a risk profile of the target population and subsequently advises interventions following a decision tree based on that risk profile. The purpose of this study was to perform an economic evaluation, from both the societal and companies' perspective, of the RSI QuickScan intervention programme for computer workers. In this study, effectiveness was defined at three levels: exposure to risk factors, prevalence of arm, shoulder and neck symptoms, and days of sick leave. Methods The economic evaluation was conducted alongside a randomised controlled trial (RCT. Participating computer workers from 7 companies (N = 638 were assigned to either the intervention group (N = 320 or the usual care group (N = 318 by means of cluster randomisation (N = 50. The intervention consisted of a tailor-made programme, based on a previously established risk profile. At baseline, 6 and 12 month follow-up, the participants completed the RSI QuickScan questionnaire. Analyses to estimate the effect of the intervention were done according to the intention-to-treat principle. To compare costs between groups, confidence intervals for cost differences were computed by bias-corrected and accelerated bootstrapping. Results The mean intervention costs, paid by the employer, were 59 euro per participant in the intervention and 28 euro in the usual care group. Mean total health care and non-health care costs per participant were 108 euro in both groups. As to the cost-effectiveness, improvement in received information on healthy computer use as well as in their work posture and movement was observed at higher costs. With regard to the other risk factors, symptoms and sick leave, only small and non-significant effects

  12. A clinical review of treatment outcomes in glioblastoma multiforme - the validation in a non-trial population of the results of a randomised Phase III clinical trial: has a more radical approach improved survival?

    LENUS (Irish Health Repository)

    Rock, K

    2012-01-03

    Objective: Glioblastoma multiforme (GBM) accounts for up to 60% of all malignant primary brain tumours in adults, occurring in 2-3 cases per 100 000 in Europe and North America. In 2005, a Phase III clinical trial demonstrated a significant improvement in survival over 2, and subsequently, 5 years with the addition of concurrent and adjuvant temozolomide (TMZ) to radical radiotherapy (RT) (Stupp R, Hegi M, van den Bent M, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol 2009:10:459-66). The aim of this study was to investigate if the demonstrated improved survival in the literature translated to clinical practice.Methods: This was a retrospective study including all patients with histologically proven GBM diagnosed from 1999 to 2008 and treated with adjuvant RT at our institution. A total of 273 patients were identified. Statistical analysis was carried out using SPSS v18.Results: The median survival for the whole group (n = 273) over the 10-year period was 7.6 months (95% confidence interval 6.7-8.4 months). Overall, the cumulative probability of survival at 1 and 2 years was 31.5 and 9.4%, respectively. In total, 146 patients received radical RT. 103 patients were treated with radical RT and TMZ and 43 patients received radical RT alone. The median survival for patients receiving radical RT with TMZ was 13.4 months (95% CI 10.9-15.8 months) vs 8.8 months for radical RT alone (95% CI 6.9 - 10.7 months, p = 0.006). 2-year survival figures were 21.2 vs 4.7%, respectively. On multivariate analysis, independent predictors of survival included KPS, RT dose, TMZ and extent of surgery. The strongest predictors of poorer outcome based on the hazard ratio were palliative RT, followed by not receiving TMZ chemotherapy, then KPS <90 and a biopsy only surgical approach.Conclusion: This paper demonstrates

  13. A clinical review of treatment outcomes in glioblastoma multiforme - the validation in a non-trial population of the results of a randomised Phase III clinical trial: has a more radical approach improved survival?

    LENUS (Irish Health Repository)

    2012-02-01

    Objective: Glioblastoma multiforme (GBM) accounts for up to 60% of all malignant primary brain tumours in adults, occurring in 2-3 cases per 100 000 in Europe and North America. In 2005, a Phase III clinical trial demonstrated a significant improvement in survival over 2, and subsequently, 5 years with the addition of concurrent and adjuvant temozolomide (TMZ) to radical radiotherapy (RT) (Stupp R, Hegi M, van den Bent M, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol 2009:10:459-66). The aim of this study was to investigate if the demonstrated improved survival in the literature translated to clinical practice.Methods: This was a retrospective study including all patients with histologically proven GBM diagnosed from 1999 to 2008 and treated with adjuvant RT at our institution. A total of 273 patients were identified. Statistical analysis was carried out using SPSS v18.Results: The median survival for the whole group (n = 273) over the 10-year period was 7.6 months (95% confidence interval 6.7-8.4 months). Overall, the cumulative probability of survival at 1 and 2 years was 31.5 and 9.4%, respectively. In total, 146 patients received radical RT. 103 patients were treated with radical RT and TMZ and 43 patients received radical RT alone. The median survival for patients receiving radical RT with TMZ was 13.4 months (95% CI 10.9-15.8 months) vs 8.8 months for radical RT alone (95% CI 6.9 - 10.7 months, p = 0.006). 2-year survival figures were 21.2 vs 4.7%, respectively. On multivariate analysis, independent predictors of survival included KPS, RT dose, TMZ and extent of surgery. The strongest predictors of poorer outcome based on the hazard ratio were palliative RT, followed by not receiving TMZ chemotherapy, then KPS <90 and a biopsy only surgical approach.Conclusion: This paper demonstrates improved

  14. Genetic variation on 9p22 is associated with abnormal ovarian ultrasound results in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

    Directory of Open Access Journals (Sweden)

    Nicolas Wentzensen

    Full Text Available BACKGROUND: A recent ovarian cancer genome-wide association study (GWAS identified a locus on 9p22 associated with reduced ovarian cancer risk. The single nucleotide polymorphism (SNP markers localize to the BNC2 gene, which has been associated with ovarian development. METHODS: We analyzed the association of 9p22 SNPs with transvaginal ultrasound (TVU screening results and CA-125 blood levels from participants without ovarian cancer in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO; 1,106 women with adequate ultrasound screening results and available genotyping information were included in the study. RESULTS: We observed a significantly increased risk of abnormal suspicious TVU results for seven SNPs on 9p22, with odds ratios between 1.68 (95% CI: 1.04-2.72 for rs4961501 and 2.10 (95% CI: 1.31-3.38 for rs12379183. Associations were restricted to abnormal suspicious findings at the first TVU screen. We did not observe an association between 9p22 SNPs and CA-125 levels. CONCLUSIONS: Our findings suggest that 9p22 SNPs, which were found to be associated with decreased risk of ovarian cancer in a recent GWAS, are associated with sonographically detectable ovarian abnormalities. Our results corroborate the relevance of the 9p22 locus for ovarian biology. Further studies are required to understand the complex relationship between screening abnormalities and ovarian carcinogenesis and to evaluate whether this locus can influence the risk stratification of ovarian cancer screening.

  15. Screening and Brief Interventions for Hazardous and Harmful Alcohol Use among University Students in South Africa: Results from a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hendry van der Heever

    2013-05-01

    Full Text Available The aim of this study was to assess the effectiveness of Screening and Brief Intervention (SBI for alcohol problems among university students in South Africa. The study design for this efficacy study is a randomized controlled trial with 6- and 12-month follow-ups to examine the effects of a brief alcohol intervention to reduce alcohol use by hazardous and harmful drinkers in a university setting. The unit of randomization is the individual university student identified as a hazardous or harmful drinker attending public recruitment venues in a university campus. University students were screened for alcohol problems, and those identified as hazardous or harmful drinkers were randomized into an experimental or control group. The experimental group received one brief counseling session on alcohol risk reduction, while the control group received a health education leaflet. Results indicate that of the 722 screened for alcohol and who agreed to participate in the trial 152 (21.1% tested positive for the Alcohol Use Disorder Identification Test (AUDIT (score 8 or more. Among the 147 (96.7% university students who also attended the 12-month follow-up session, the intervention effect on the AUDIT score was −1.5, which was statistically significant (P = 0.009. Further, the depression scores marginally significantly decreased over time across treatment groups, while other substance use (tobacco and cannabis use, self-rated health status and Posttraumatic Stress Disorder (PTSD scores did not change over time across treatment groups. The study provides evidence of effective brief intervention by assistant nurses with hazardous and harmful drinkers in a university setting in South Africa. The short duration of the brief intervention makes it a realistic candidate for use in a university setting.

  16. Mortality in members of HIV-1 serodiscordant couples in Africa and implications for antiretroviral therapy initiation: Results of analyses from a multicenter randomized trial

    Directory of Open Access Journals (Sweden)

    de Bruyn Guy

    2012-10-01

    Full Text Available Abstract Background The risk of HIV-1 related mortality is strongly related to CD4 count. Guidance on optimal timing for initiation of antiretroviral therapy (ART is still evolving, but the contribution of HIV-1 infection to excess mortality at CD4 cell counts above thresholds for HIV-1 treatment has not been fully described, especially in resource-poor settings. To compare mortality among HIV-1 infected and uninfected members of HIV-1 serodiscordant couples followed for up to 24 months, we conducted a secondary data analysis examining mortality among HIV-1 serodiscordant couples participating in a multicenter, randomized controlled trial at 14 sites in seven sub-Saharan African countries. Methods Predictors of death were examined using Cox regression and excess mortality by CD4 count and plasma HIV-1 RNA was computed using Poisson regression for correlated data. Results Among 3295 HIV serodiscordant couples, we observed 109 deaths from any cause (74 deaths among HIV-1 infected and 25 among HIV-1 uninfected persons. Among HIV-1 infected persons, the risk of death increased with lower CD4 count and higher plasma viral levels. HIV-1 infected persons had excess mortality due to medical causes of 15.2 deaths/1000 person years at CD4 counts of 250 – 349 cells/μl and 8.9 deaths at CD4 counts of 350 – 499 cells/μl. Above a CD4 count of 500 cells/μl, mortality was comparable among HIV-1 infected and uninfected persons. Conclusions Among African serodiscordant couples, there is a high rate of mortality attributable to HIV-1 infection at CD4 counts above the current threshold (200 – 350 cells/μl for ART initiation in many African countries. These data indicate that earlier initiation of treatment is likely to provide clinical benefit if further expansion of ART access can be achieved. Trial Registration Clinicaltrials.gov (NCT00194519

  17. Can community retail pharmacist and diabetes expert support facilitate insulin initiation by family physicians? Results of the AIM@GP randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Harris Stewart B

    2013-02-01

    Full Text Available Abstract Background Limited evidence exists on the effectiveness of external diabetes support provided by diabetes specialists and community retail pharmacists to facilitate insulin-prescribing in family practice. Methods A stratified, parallel group, randomized control study was conducted in 15 sites across Canada. Family physicians received insulin initiation/titration education, a physician-specific ‘report card’ on the characteristics of their type 2 diabetes (T2DM population, and a registry of insulin-eligible patients at a workshop. Intervention physicians in addition received: (1 diabetes specialist/educator consultation support (active diabetes specialist/educator consultation support for 2 months [the educator initiated contact every 2 weeks] and passive consultation support for 10 months [family physician initiated as needed]; and (2 community retail pharmacist support (option to refer patients to the pharmacist(s for a 1-hour insulin-initiation session. The primary outcome was the insulin prescribing rate (IPR per physician defined as the number of insulin starts of insulin-eligible patients during the 12-month strategy. Results Consenting, eligible physicians (n = 151 participated with 15 specialist sites and 107 community pharmacists providing the intervention. Most physicians were male (74%, and had an average of 81 patients with T2DM. Few (9% routinely initiated patients on insulin. Physicians were randomly allocated to usual care (n = 78 or the intervention (n = 73. Intervention physicians had a mean (SE IPR of 2.28 (0.27 compared to 2.29 (0.25 for control physicians, with an estimated adjusted RR (95% CI of 0.99 (0.80 to 1.24, p = 0.96. Conclusions An insulin support program utilizing diabetes experts and community retail pharmacists to enhance insulin prescribing in family practice was not successful. Too few physicians are appropriately intensifying diabetes management through insulin initiation, and

  18. Increasing Dose of Autologous Bone Marrow Mononuclear Cells Transplantation Is Related to Stroke Outcome: Results from a Pooled Analysis of Two Clinical Trials

    Science.gov (United States)

    Escudero, Irene; Zapata, Elena; de la Torre Laviana, Francisco Javier; Carmona, Magdalena; Piñero, Pilar; Bustamante, Alejandro; Lebrato, Lucía; Cabezas, Juan Antonio; Gonzalez, Alejandro; de Freitas, Grabriel R.; Montaner, Joan

    2016-01-01

    Background and Purpose. BM-MNC transplantation improves recovery in experimental models of ischemic stroke. Clinical trials are ongoing to test efficacy in stroke patients. However, whether cell dose is related to outcomes is not known. Methods. We performed a pooling data analysis of two pilot clinical trials with autologous BM-MNCs transplantation in ischemic stroke patients. Cell dose and route were analyzed to evaluate their relation to good outcome (m-Rankin scale [mRS] score 0–2) at 6 months. Results. Twenty-two patients were included. A median of 153 × 106 (±121 × 106) BM-MNCs was injected. Intra-arterial route was used in 77.3% of cases. A higher number of cells injected were associated with better outcomes at 180 days (390 × 106 [320–422] BM-MNCs injected in those patients with mRS of 0–2 at 6 months versus 130 × 106 [89–210] in those patients with mRS 3–6, p = 0.015). In the intra-arterially treated patients, a strong correlation between dose of cells and disability was found (r = −0.63, p = 0.006). A cut point of 310 × 106 injected cells predicted good outcome with 80% sensitivity and 88.2% specificity. Conclusions. Similar to preclinical studies, a higher dose of autologous BM-MNC was related to better outcome in stroke patients, especially when more than 310 × 106 cells are injected. Further interventional studies are warranted to confirm these data. PMID:27525011

  19. Higher risk of death and stroke in patients with persistent vs. paroxysmal atrial fibrillation: results from the ROCKET-AF Trial

    Science.gov (United States)

    Steinberg, Benjamin A.; Hellkamp, Anne S.; Lokhnygina, Yuliya; Patel, Manesh R.; Breithardt, Günter; Hankey, Graeme J.; Becker, Richard C.; Singer, Daniel E.; Halperin, Jonathan L.; Hacke, Werner; Nessel, Christopher C.; Berkowitz, Scott D.; Mahaffey, Kenneth W.; Fox, Keith A.A.; Califf, Robert M.; Piccini, Jonathan P.

    2015-01-01

    Aim Anticoagulation prophylaxis for stroke is recommended for at-risk patients with either persistent or paroxysmal atrial fibrillation (AF). We compared outcomes in patients with persistent vs. paroxysmal AF receiving oral anticoagulation. Methods and results Patients randomized in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET-AF) trial (n = 14 264) were grouped by baseline AF category: paroxysmal or persistent. Multivariable adjustment was performed to compare thrombo-embolic events, bleeding, and death between groups, in high-risk subgroups, and across treatment assignment (rivaroxaban or warfarin). Of 14 062 patients, 11 548 (82%) had persistent AF and 2514 (18%) had paroxysmal AF. Patients with persistent AF were marginally older (73 vs. 72, P = 0.03), less likely female (39 vs. 45%, P < 0.0001), and more likely to have previously used vitamin K antagonists (64 vs. 56%, P < 0.0001) compared with patients with paroxysmal AF. In patients randomized to warfarin, time in therapeutic range was similar (58 vs. 57%, P = 0.94). Patients with persistent AF had higher adjusted rates of stroke or systemic embolism (2.18 vs. 1.73 events per 100-patient-years, P = 0.048) and all-cause mortality (4.78 vs. 3.52, P = 0.006). Rates of major bleeding were similar (3.55 vs. 3.31, P = 0.77). Rates of stroke or systemic embolism in both types of AF did not differ by treatment assignment (rivaroxaban vs. warfarin, Pinteraction = 0.6). Conclusion In patients with AF at moderate-to-high risk of stroke receiving anticoagulation, those with persistent AF have a higher risk of thrombo-embolic events and worse survival compared with paroxysmal AF. PMID:25209598

  20. Point-of-care continuous 13C-methacetin breath test improves decision making in acute liver disease: Results of a pilot clinical trial

    Institute of Scientific and Technical Information of China (English)

    Gadi Lalazar; Tomer Adar; Yaron Ilan

    2009-01-01

    AIM: To assess the role of the 13C-methacetin breath test (MBT) in patients with acute liver disease. METHODS: Fifteen patients with severe acute liver disease from diverse etiologies were followed-up with 13C-MBT during the acute phase of their illnesses (range 3-116 d after treatment). Patients fasted for 8 h and ingested 75 mg of methacetin prior to the MBT. We compared results from standard clinical assessment, serum liver enzymes, synthetic function, and breath test scores. RESULTS: Thirteen patients recovered and two patients died. In patients that recovered, MBT parameters improved in parallel with improvements in lab results. Evidence of consistent improvement began on day 3 for MBT parameters and between days 7 and 9 for blood tests. Later convergence to normality occurred at an average of 9 d for MBT parameters and from 13 to 28 d for blood tests. In both patients that died, MBT parameters remained low despite fluctuating laboratory values. CONCLUSION: The 13C-MBT provides a rapid, noninvasive assessment of liver function in acute severe liver disease of diverse etiologies. The results of this pilot clinical trial suggest that the MBT may offer greater sensitivity than standard clinical tests for managing patients with severe acute liver disease.

  1. Capecitabine in combination with novel targeted agents in the management of metastatic breast cancer: underlying rationale and results of clinical trials.

    Science.gov (United States)

    Tripathy, Debu

    2007-04-01

    At present there is no established standard of care for metastatic breast cancer and prognosis remains poor, although the use of newer chemotherapeutic regimens has led to modest improvements in survival. Capecitabine, an oral prodrug of 5-fluorouracil, is a promising addition to these approaches, having already shown single-agent activity against metastatic breast cancer. Following a pivotal trial demonstrating that capecitabine confers increased survival when used in combination with docetaxel, it is being investigated intensively in combined regimens using other standard chemotherapeutic agents, as well as with novel molecularly targeted therapies. Among the novel agents, the most intensively studied in combination with capecitabine is trastuzumab. Despite preclinical data suggesting that these two agents might not show additive effects, clinical trials have been very encouraging for both heavily pretreated patients and for patients receiving first-line therapy in the metastatic setting. This work is being further extended in an ongoing trial in the neoadjuvant setting. An initial trial in combination with bevacizumab, enrolling heavily pretreated patients, was less successful, but following the example of the E2100 trial, this combination is being re-examined in less heavily treated patients. In addition, this review discusses ongoing trials with an array of newer molecularly targeted agents. Significant improvement in time to progression has already been demonstrated in the combination of lapatinib and capecitabine compared with capecitabine monotherapy; for the most part, however, these trials are still in early stages.

  2. Clean Coal III Project: Blast Furnace Granular Coal Injection Project Trial 1 Report - Blast Furnace Granular Coal Injection - Results with Low Volatile Coal

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    1997-11-01

    This report describes the first coal trial test conducted with the Blast Furnace Granular Coal Injection System at Bethlehem Steel Corporation's Burns Harbor Plant. This demonstration project is divided into three phases: Phase I - Design Phase II - Construction Phase III - Operation The design phase was conducted in 1991-1993. Construction of the facility began in August 1993 and was completed in late 1994. The coal injection facility began operating in January 1995 and Phase III began in November 1995. The Trial 1 base test orI C furnace was carried out in October 1996 as a comparison period for the analysis of the operation during subsequent coal trials.

  3. Beneficial effects of citrus juice fermented with Lactobacillus plantarum YIT 0132 on atopic dermatitis: results of daily intake by adult patients in two open trials

    OpenAIRE

    HARIMA-MIZUSAWA, Naomi; Kamachi, Keiko; Kano, Mitsuyoshi; NOZAKI, Daisuke; UETAKE, Tatsuo; YOKOMIZO, Yuji; Nagino, Takayuki; Tanaka, Akira; MIYAZAKI, Kouji; Nakamura, Shinichiro

    2015-01-01

    This study aimed to examine whether daily intake of citrus juice containing heat-killed Lactobacillus plantarum YIT 0132 (LP0132-fermented juice) alleviates symptoms of atopic dermatitis. This was a natural extension of our previous study in which LP0132 was shown to enhance IL-10 production in vitro and LP0132-fermented juice was found to alleviate symptoms and enhance quality of life (QOL) in patients with Japanese cedar pollinosis. In two open trials, Trial 1 and Trial 2, 32 and 18 adult p...

  4. 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)

    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)

  5. AK-2123 (Sanazol as a radiation sensitizer in the treatment of stage iii cancer cervix: Initial results of an IAEA multicentre randomized trial

    Directory of Open Access Journals (Sweden)

    Dobrowsky Werner

    2005-01-01

    Full Text Available PURPOSE : AK-2123, a nitrotriazole hypoxic cell sensitizer has reportedly improved results in head and neck cancers, uterine cervical cancers and other solid tumours when added to radical radiotherapy. A prospectively randomised trial was initiated by the International Atomic Energy Agency (IAEA evaluating AK-2123 and radiotherapy in treatment of uterine cervical cancer stage IIIA and IIIB. MATERIALS AND METHODS : A total of 333 patients were randomised between May1995 and December1998. Patients were randomised to either standard radical treatment (radiation therapy alone, RT or standard radical radiotherapy and additional administration of AK-2123 (RT+AK-2123. The total dose of 45-50.8 Gy was delivered in 20 to 28 fractions over 4 to 5 1/2 weeks. The dose to the central disease was escalated to a radiobiologically equivalent dose of 70 Gy by external beam or brachytherapy, in accordance with each centres individual practice. In the study arm, patients received 0.6 g/sqm AK-2123 by intravenous administration before external beam radiotherapy, treating with AK-2123 on alternate days (e.g. Monday-Wednesday-Friday during the entire course of external beam therapy . RESULTS: After a median follow up of 57 months (range 30-73 months the rate of local tumour control was significantly higher in the group who received radiotherapy and additional administration of AK-2123. Local tumour control at the last follow up was 61% after combined radiotherapy and AK-2123 and 46% after radiotherapy alone (p = 0.005. AK-2123 neither increased gastro-intestinal toxicity nor gave any haematological toxicity. A mild peripheral neuropathy (Grade 1:11% and Grade 2:3% was seen infrequently after AK-2123 administration and was usually completely reversible. Crude survival rates were 41% after radical treatment compared to 57% after combined therapy (p = 0.007 CONCLUSION : We conclude that the addition of AK-2123 to radical radiotherapy significantly increases response

  6. Long-term magnesium supplementation improves arterial stiffness in overweight and obese adults : results of a randomized, double-blind, placebo-controlled intervention trial

    NARCIS (Netherlands)

    Joris, Peter J.; Plat, Jogchum; Bakker, Stephan J. L.; Mensink, Ronald P.

    2016-01-01

    Background: Epidemiologic studies have suggested a protective effect of magnesium intake on cardiovascular disease risk. However, intervention trials of magnesium supplementation on blood pressure and conventional cardiometabolic risk markers are inconsistent. Effects on vascular function markers re

  7. Daily Pomegranate intake has no impact on PSA levels in patients with advanced prostate cancer - Results of a phase IIb randomized controlled trial

    OpenAIRE

    Stenner-Liewen, Frank; Liewen, Heike; Cathomas, Richard; Renner, Christoph; Petrausch, Ulf; Sulser, Tullio; Spanaus, Katharina; Seifert, Hans Helge; Strebel, Räto Thomas; Knuth, Alexander; Samaras, Panagiotis; Müntener, Michael

    2013-01-01

    Pomegranate has been shown to prolong PSA doubling time in early prostate cancer, but no data from a placebo controlled trial has been published yet. The objective of this study was to prospectively evaluate the impact of pomegranate juice in patients with prostate cancer. We conducted a phase IIb, double blinded, randomized placebo controlled trial in patients with histologically confirmed prostate cancer. Only patients with a PSA value ≥ 5ng/ml were included. The subjects consumed 500 ml of...

  8. Superion® InterSpinous Spacer for treatment of moderate degenerative lumbar spinal stenosis: durable three-year results of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Patel VV

    2015-10-01

    Full Text Available Vikas V Patel,1 Pierce D Nunley,2 Peter G Whang,3 Thomas R Haley,4 W Daniel Bradley,5 Raphael P Davis,6 Jon E Block,7 Fred H Geisler8 1The Spine Center, University of Colorado Hospital, Denver, CO, 2Spine Institute of Louisiana, Shreveport, LA, 3Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, New Haven, CT, 4Performance Spine and Sports Physicians, PC, Pottstown, PA, 5Texas Back Institute, Denton, TX, 6Department of Neurological Surgery, Stony Brook Medicine, Stony Brook, NY, 7Jon Block, Ph.D. San Francisco, CA, 8McLaren Hospital, Petoskey, MI, USA Purpose: This report provides the 3-year clinical outcomes from the randomized, controlled US Food and Drug Administration Investigational Device Exemption trial of the Superion® for the treatment of moderate degenerative lumbar spinal stenosis. Patients and methods: The Superion® was evaluated in the treatment of subjects aged 45 years or older suffering from symptoms of intermittent neurogenic claudication, secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5. Patients were treated between June 2008 and December 2011 at 31 investigational sites. Three hundred ninety-one subjects were included in the randomized study group consisting of 190 Superion® and 201 X-STOP® control subjects. The primary composite endpoint was individual patient success based on four components: improvement in two of three domains of the Zurich Claudication Questionnaire, no reoperations at the index level, no major implant/procedure-related complications, and no clinically significant confounding treatments. Results: At 3 years, the proportion of subjects achieving the primary composite endpoint was greater for Superion® (63/120, 52.5% than for X-STOP® (49/129, 38.0% (P=0.023 and the corresponding success rates exceeded 80% for each of the individual components of the primary endpoint in the Superion® group

  9. Efficacy and safety of strontium ranelate in the treatment of knee osteoarthritis: results of a double-blind, randomised placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Jean-Yves Reginster

    2014-02-01

    Full Text Available Objective. Background Strontium ranelate is currently used for osteoporosis. The international, double-blind, randomised, placebo-controlled Strontium ranelate Efficacy in Knee OsteoarthrItis triAl evaluated its effect on radiological progression of knee osteoarthritis.Methods. Patients with knee osteoarthritis (Kellgren and Lawrence grade 2 or 3, and joint space width (JSW 2.5-5 mm were randomly allocated to strontium ranelate 1 g/day (n=558, 2 g/day (n=566 or placebo (n=559. The primary endpoint was radiographical change in JSW (medial tibiofemoral compartment over 3 years versus placebo. Secondary endpoints included radiological progression, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC score, and knee pain. The trial is registered (ISRCTN41323372.Results. The intention-to-treat population included 1371 patients. Treatment with strontium ranelate was associated with smaller degradations in JSW than placebo (1 g/day: -0.23 (SD 0.56 mm; 2 g/day: -0.27 (SD 0.63 mm; placebo:-0.37 (SD 0.59 mm; treatment-placebo differences were 0.14 (SE 0.04, 95% CI 0.05 to 0.23, p<0.001 for 1 g/day and 0.10 (SE 0.04, 95% CI 0.02 to 0.19, p=0.018 for 2 g/day. Fewer radiological progressors were observed withstrontium ranelate (p<0.001 and p=0.012 for 1 and 2 g/day. There were greater reductions in total WOMAC score (p=0.045, pain subscore (p=0.028, physical function subscore (p=0.099 and knee pain (p=0.065 with strontium ranelate 2 g/day. Strontium ranelate was well tolerated. Conclusions. Treatment with strontium ranelate 1 and 2 g/day is associated with a significant effect on structure in patients with knee osteoarthritis, and a beneficial effect on symptoms for strontium ranelate 2 g/day.Additional supplementary data are published online only. To view these files please visit the journal online (http://dx.doi. org/10.1136/annrheumdis-2012-202231

  10. Cost-effectiveness of tailored print communication, telephone motivational interviewing, and a combination of the two: results of an economic evaluation alongside the Vitalum randomized controlled trial

    Directory of Open Access Journals (Sweden)

    van Keulen Hilde M

    2010-09-01

    Full Text Available Abstract Background The aim of the present study was to evaluate the cost-effectiveness of tailored print communication (TPC, telephone motivational interviewing (TMI, a combination of the two, and no intervention on two outcomes in adults aged 45 to 70, half of them having hypertension: increasing the number of public health guidelines met for three behaviors (physical activity and fruit and vegetable consumption, and impact on quality adjusted life years (QALYs. Methods Participants (n = 1,629 from 23 Dutch general practices were randomized into one of four groups, which received 4 TPCs, 4 TMIs, 2 of each (combined, or no intervention (control, respectively. The self-reported outcomes, measured at baseline and 73 weeks follow-up (7 months after the last intervention component, were difference in total number of guidelines met at follow-up compared to baseline, and number of QALYs experienced over 73 weeks. The costs of implementing the intervention were estimated using a bottom-up approach. Results At 73 weeks follow-up participants showed increased adherence with 0.62 (TPC, 0.40 (TMI, 0.50 (combined, and 0.26 (control guidelines compared to baseline, and experienced 1.09, 1.08, 1.08, and 1.07 QALYs, respectively. The costs for the control group were considered to be zero. TMI was more expensive (€107 per person than both the combined intervention (€80 and TPC (€57. The control condition was most cost-effective for lower ceiling ratios, while TPC had the highest probability of being most cost-effective for higher ceiling ratios (more than €160 per additional guideline met, and €2,851 for each individual QALY. Conclusions For low society's willingness to pay, the control group was most cost-effective for the number of QALYs experienced over 73 weeks. This also applied to the increase in the number of guidelines met at lower ceiling ratios, whereas at higher ceiling ratios, TPC had a higher probability of being more cost-effective than

  11. Risk of Late Toxicity in Men Receiving Dose-Escalated Hypofractionated Intensity Modulated Prostate Radiation Therapy: Results From a Randomized Trial

    Energy Technology Data Exchange (ETDEWEB)

    Hoffman, Karen E., E-mail: khoffman1@mdanderson.org; Voong, K. Ranh; Pugh, Thomas J.; Skinner, Heath; Levy, Lawrence B.; Takiar, Vinita; Choi, Seungtaek; Du, Weiliang; Frank, Steven J.; Johnson, Jennifer; Kanke, James; Kudchadker, Rajat J.; Lee, Andrew K.; Mahmood, Usama; McGuire, Sean E.; Kuban, Deborah A.

    2014-04-01

    Objective: To report late toxicity outcomes from a randomized trial comparing conventional and hypofractionated prostate radiation therapy and to identify dosimetric and clinical parameters associated with late toxicity after hypofractionated treatment. Methods and Materials: Men with localized prostate cancer were enrolled in a trial that randomized men to either conventionally fractionated intensity modulated radiation therapy (CIMRT, 75.6 Gy in 1.8-Gy fractions) or to dose-escalated hypofractionated IMRT (HIMRT, 72 Gy in 2.4-Gy fractions). Late (≥90 days after completion of radiation therapy) genitourinary (GU) and gastrointestinal (GI) toxicity were prospectively evaluated and scored according to modified Radiation Therapy Oncology Group criteria. Results: 101 men received CIMRT and 102 men received HIMRT. The median age was 68, and the median follow-up time was 6.0 years. Twenty-eight percent had low-risk, 71% had intermediate-risk, and 1% had high-risk disease. There was no difference in late GU toxicity in men treated with CIMRT and HIMRT. The actuarial 5-year grade ≥2 GU toxicity was 16.5% after CIMRT and 15.8% after HIMRT (P=.97). There was a nonsignificant numeric increase in late GI toxicity in men treated with HIMRT compared with men treated with CIMRT. The actuarial 5-year grade ≥2 GI toxicity was 5.1% after CIMRT and 10.0% after HIMRT (P=.11). In men receiving HIMRT, the proportion of rectum receiving 36.9 Gy, 46.2 Gy, 64.6 Gy, and 73.9 Gy was associated with the development of late GI toxicity (P<.05). The 5-year actuarial grade ≥2 GI toxicity was 27.3% in men with R64.6Gy ≥ 20% but only 6.0% in men with R64.6Gy < 20% (P=.016). Conclusions: Dose-escalated IMRT using a moderate hypofractionation regimen (72 Gy in 2.4-Gy fractions) can be delivered safely with limited grade 2 or 3 late toxicity. Minimizing the proportion of rectum that receives moderate and high dose decreases the risk of late rectal toxicity after this

  12. Promoting mobility after hip fracture (ProMo: study protocol and selected baseline results of a year-long randomized controlled trial among community-dwelling older people

    Directory of Open Access Journals (Sweden)

    Sipilä Sarianna

    2011-12-01

    Full Text Available Abstract Background To cope at their homes, community-dwelling older people surviving a hip fracture need a sufficient amount of functional ability and mobility. There is a lack of evidence on the best practices supporting recovery after hip fracture. The purpose of this article is to describe the design, intervention and demographic baseline results of a study investigating the effects of a rehabilitation program aiming to restore mobility and functional capacity among community-dwelling participants after hip fracture. Methods/Design Population-based sample of over 60-year-old community-dwelling men and women operated for hip fracture (n = 81, mean age 79 years, 78% were women participated in this study and were randomly allocated into control (Standard Care and ProMo intervention groups on average 10 weeks post fracture and 6 weeks after discharged to home. Standard Care included written home exercise program with 5-7 exercises for lower limbs. Of all participants, 12 got a referral to physiotherapy. After discharged to home, only 50% adhered to Standard Care. None of the participants were followed-up for Standard Care or mobility recovery. ProMo-intervention included Standard Care and a year-long program including evaluation/modification of environmental hazards, guidance for safe walking, pain management, progressive home exercise program and physical activity counseling. Measurements included a comprehensive battery of laboratory tests and self-report on mobility limitation, disability, physical functional capacity and health as well as assessments for the key prerequisites for mobility, disability and functional capacity. All assessments were performed blinded at the research laboratory. No significant differences were observed between intervention and control groups in any of the demographic variables. Discussion Ten weeks post hip fracture only half of the participants were compliant to Standard Care. No follow-up for Standard Care or

  13. Muscle uncoupling protein 3 expression is unchanged by chronic ephedrine/caffeine treatment: results of a double blind, randomised clinical trial in morbidly obese females.

    Directory of Open Access Journals (Sweden)

    Renata Bracale

    Full Text Available Ephedrine/caffeine combination (EC has been shown to induce a small-to-moderate weight loss in obese patients. Several mechanisms have been proposed, among which an increased thermogenic capacity of skeletal muscle consequent to the EC-induced up-regulation of uncoupling protein 3 (UCP3 gene expression. We did a parallel group double-blind, placebo-controlled, 4-week trial to investigate this hypothesis. Thirteen morbidly obese women (25-52 years of age, body-mass index 48.0±4.0 kg/m2, range 41.1-57.6 were randomly assigned to EC (200/20 mg, n = 6 or to placebo (n = 7 administered three times a day orally, before undergoing bariatric surgery. All individuals had an energy-deficit diet equal to about 70% of resting metabolic rate (RMR diet (mean 5769±1105 kJ/day. The RMR analysed by intention to treat and the UCP3 (long and short isoform mRNA levels in rectus abdominis were the primary outcomes. Body weight, plasma levels of adrenaline, noradrenaline, triglycerides, free fatty acids, glycerol, TSH, fT4, and fT3 were assessed, as well as fasting glucose, insulin and HOMA index, at baseline and at the end of treatments. Body weight loss was evident in both groups when compared to baseline values (overall -5.2±3.2%, p<0.0001 without significant differences between the treated groups. EC treatment increased the RMR (+9.2±6.8%, p = 0.020, differently from placebo which was linked to a reduction of RMR (-7.6±6.5%, p = 0.029. No significant differences were seen in other metabolic parameters. Notably, no changes of either UCP3 short or UCP3 long isoform mRNA levels were evident between EC and placebo group. Our study provides evidence that 4-week EC administration resulted in a pronounced thermogenic effect not related to muscle UCP3 gene expression and weight loss in morbidly obese females under controlled conditions.ClinicalTrials.gov NCT02048215.

  14. Effectiveness of a worksite social & physical environment intervention on need for recovery, physical activity and relaxation; results of a randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Jennifer K Coffeng

    Full Text Available OBJECTIVE: To investigate the effectiveness of a worksite social and physical environment intervention on need for recovery (i.e., early symptoms of work-related mental and physical fatigue, physical activity and relaxation. Also, the effectiveness of the separate interventions was investigated. METHODS: In this 2 × 2 factorial design study, 412 office employees from a financial service provider participated. Participants were allocated to the combined social and physical intervention, to the social intervention only, to the physical intervention only or to the control group. The primary outcome measure was need for recovery. Secondary outcomes were work-related stress (i.e., exhaustion, detachment and relaxation, small breaks, physical activity (i.e., stair climbing, active commuting, sport activities, light/moderate/vigorous physical activity and sedentary behavior. Outcomes were measured by questionnaires at baseline, 6 and 12 months follow-up. Multilevel analyses were performed to investigate the effects of the three interventions. RESULTS: In all intervention groups, a non-significant reduction was found in need for recovery. In the combined intervention (n = 92, exhaustion and vigorous physical activities decreased significantly, and small breaks at work and active commuting increased significantly compared to the control group. The social intervention (n = 118 showed a significant reduction in exhaustion, sedentary behavior at work and a significant increase in small breaks at work and leisure activities. In the physical intervention (n = 96, stair climbing at work and active commuting significantly increased, and sedentary behavior at work decreased significantly compared to the control group. CONCLUSION: None of the interventions was effective in improving the need for recovery. It is recommended to implement the social and physical intervention among a population with higher baseline values of need for recovery. Furthermore, the

  15. The Cardiovascular Health of Urban African-Americans: Dietary Results from the Genes, Nutrition, Exercise, Wellness and Spiritual Growth (GoodNEWS) Trial

    Science.gov (United States)

    Carson, Jo Ann S.; Michalsky, Linda; Latson, Bernadette; Banks, Kamakki; Tong, Liyue; Gimpel, Nora; Lee, Jenny J.; DeHaven, Mark J.

    2012-01-01

    African-Americans have a higher incidence of cardiovascular disease (CVD) than Americans in general and are thus prime targets for efforts to reduce CVD risk. Dietary intake data were obtained from African-Americans participating in the GoodNEWS trial. The 286 females and 71 males had a mean age of 49 years; 53% had hypertension, 65% had dyslipidemia and 51% met criteria for metabolic syndrome. Their dietary intakes were compared to American Heart Association and National Heart Lung and Blood Institute nutritional parameters to identify areas for improvement to reduce CVD risk in this group of urban church members in Dallas, Texas. Results from administration of the Dietary History Questionnaire (DHQ) indicated median daily intakes of 33.6 % of energy from total fat, 10.3% of energy from saturated fat, 171 mg cholesterol, 16.3 g dietary fiber, and 2453 mg sodium. A beneficial median intake of 2.9 cups of fruits and vegetable/day was coupled with only 2.7 oz fish/week and an excessive intake of 13 tsp added sugar/day. These data indicate several changes needed to bring the diets of these individuals, and likely many other urban African-Americans, in line with national recommendations: reduction of saturated fat, sodium and sugar intake, while increasing intake of fatty fish and whole grains. The frequent inclusion of vegetables should be encouraged in ways that promote achievement of recommended intakes of energy, fat, fiber and sodium. PMID:22995059

  16. The use of skin surface electropotentials for breast cancer detection--preliminary clinical trial results obtained using the biofield diagnostic system.

    Science.gov (United States)

    Sree, Subbhuraam Vinitha; Ng, E Y K; Kaw, G; U, Rajendra Acharya; Chong, B K

    2011-02-01

    The purpose of this study is to evaluate the efficiency of the Biofield Diagnostic System (BDS) as an adjunct to established diagnostic techniques such as mammography and ultrasound in differentiating benign and malignant breast lesions. The clinical trial was conducted at the Tan Tock Seng hospital, Singapore. 103 women scheduled for mammography and/or ultrasound tests participated in the study. The BDS test recorded a sensitivity of 100%, specificity of 97.6%, and an accuracy of 98.1%. The area under the ROC curve was 0.988 which was slightly lower than that of ultrasound (0.994) and slightly higher than that of mammography (0.951). The BDS test has demonstrated high sensitivity and specificity values in the studied population. The accuracy is also comparable to that of diagnostic techniques like mammography and ultrasound. Thus, it is evident that BDS can be a fast and reliable adjunct tool for getting a secondary opinion on lesions with indeterminate mammographic and sonographic results.

  17. Combined 18F-Fluoride and 18F-FDG PET/CT Scanning for Evaluation of Malignancy: Results of an International Multicenter Trial

    DEFF Research Database (Denmark)

    Iagaru, Andrei; Mittra, Erik; Mosci, Camila;

    2012-01-01

    18F-FDG PET/CT is used in a variety of cancers, but because of variable rates of glucose metabolism, not all cancers are reliably identified. 18F2 PET/CT allows for the acquisition of highly sensitive and specific images of the skeleton. We prospectively evaluated combined 18F2/18F-FDG as a single...... PET/CT examination for evaluation of cancer patients and compared it with separate 18F2 PET/CT and 18F-FDG PET/CT scans. Methods: One hundred fifteen participants with cancer were prospectively enrolled in an international multicenter trial evaluating 18F2 PET/CT, 18F-FDG PET/CT, and combined 18F2/18F......-FDG PET/CT. The 3 PET/CT scans were performed sequentially within 4 wk of one another for each patient. Results: 18F2/18FFDG PET/CT allowed for accurate interpretation of radiotracer uptake outside the skeleton, with findings similar to those of 18F-FDG PET/CT. In 19 participants, skeletal disease...

  18. Antioxidant therapy for chronic hepatitis C after failure of interferon: Results of phase Ⅱ randomized, double-blind placebo controlled clinical trial

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    AIM: To assess the safety and efficacy of antioxidant therapy for patients with chronic hepatitis C virus (HCV) infection. METHODS: One hundred chronic HCV infection patients failed in interferon treatment were enrolled and randomly assigned to receive combined intravenous and oral antioxidants or placebo, or oral treatment alone. Primary end points were liver enzymes, HCV-RNA levels and histology. RESULTS: Combined oral and intravenous antioxidant therapy was associated with a significant decline in ALT levels in 52% of patients who received antioxidant therapy vs 20% of patients who received placebo (P = 0.05). Histology activity index (HAI) score at the end of treatment was reduced in 48% of patients who received antioxidant therapy vs 26% of patients who received placebo (P = 0.21). HCV-RNA levels decreased by 1-log or more in 28% of patients who received antioxidant therapy vs 12% who received placebo (P = NS). In part Ⅱ of the trial, oral administration of antioxidants was not associated with significant alterations in any of the end points. CONCLUSION: Antioxidant therapy has a mild beneficial effect on the inflammatory response of chronic HCV infection patients who are non-responders to interferon. Combined antiviral and antioxidant therapy may be beneficial for these patients.

  19. No significant improvement of cardiovascular disease risk indicators by a lifestyle intervention in people with Familial Hypercholesterolemia compared to usual care: results of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Broekhuizen Karen

    2012-07-01

    Full Text Available Abstract Background People with Familial Hypercholesterolemia (FH may benefit from lifestyle changes supporting their primary treatment of dyslipidaemia. This project evaluated the efficacy of an individualised tailored lifestyle intervention on lipids (low density lipoprotein cholesterol (LDL-C, high density lipoprotein cholesterol (HDL-C, total cholesterol (TC and triglycerides, systolic blood pressure, glucose, body mass index (BMI and waist circumference in people with FH. Methods Adults with FH (n = 340, recruited from a Dutch cascade screening program, were randomly assigned to either a control group or an intervention group. The personalised intervention consisted of web-based tailored lifestyle advice and personal counselling. The control group received care as usual. Lipids, systolic blood pressure, glucose, BMI, and waist circumference were measured at baseline and after 12 months. Regression analyses were conducted to examine differences between both groups. Results After 12 months, no significant between-group differences of cardiovascular disease (CVD risk indicators were observed. LDL-C levels had decreased in both the intervention and control group. This difference between intervention and control group was not statistically significant. Conclusions This project suggests that an individually tailored lifestyle intervention did not have an additional effect in improving CVD risk indicators among people with FH. The cumulative effect of many small improvements in all indicators on long term CVD risk remains to be assessed in future studies. Trial registration NTR1899 at ww.trialregister.nl

  20. Deferiprone versus deferoxamine in sickle cell disease: results from a 5-year long-term Italian multi-center randomized clinical trial.

    Science.gov (United States)

    Calvaruso, Giusi; Vitrano, Angela; Di Maggio, Rosario; Ballas, Samir; Steinberg, Martin H; Rigano, Paolo; Sacco, Massimiliano; Telfer, Paul; Renda, Disma; Barone, Rita; Maggio, Aurelio

    2014-12-01

    Blood transfusion and iron chelation currently represent a supportive therapy to manage anemia, vasculopathy and vaso-occlusion crises in Sickle-Cell-Disease. Here we describe the first 5-year long-term randomized clinical trial comparing Deferiprone versus Deferoxamine in patients with Sickle-Cell-Disease. The results of this study show that Deferiprone has the same effectiveness as Deferoxamine in decreasing body iron burden, measured as repeated measurements of serum ferritin concentrations on the same patient over 5-years and analyzed according to the linear mixed-effects model (LMM) (p=0.822). Both chelators are able to decrease, significantly, serum ferritin concentrations, during 5-years, without any effect on safety (p=0.005). Moreover, although the basal serum ferritin levels were higher in transfused compared with non-transfused group (p=0.031), the changes over time in serum ferritin levels were not statistically significantly different between transfused and non-transfused cohort of patients (p=0.389). Kaplan-Meier curve, during 5-years of study, suggests that Deferiprone does not alter survival in comparison with Deferoxamine (p=0.38). In conclusion, long-term iron chelation therapy with Deferiprone was associated with efficacy and safety similar to that of Deferoxamine. Therefore, in patients with Sickle-Cell-Disease, Deferiprone may represent an effective long-term treatment option. PMID:24814618

  1. Surgery is more cost-effective than splinting for carpal tunnel syndrome in the Netherlands: results of an economic evaluation alongside a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Adèr Herman J

    2006-11-01

    Full Text Available Abstract Background Carpal tunnel syndrome (CTS is a common disorder, often treated with surgery or wrist splinting. The objective of this economic evaluation alongside a randomized trial was to evaluate the cost-effectiveness of splinting and surgery for patients with CTS. Methods Patients at 13 neurological outpatient clinics with clinically and electrophysiologically confirmed idiopathic CTS were randomly allocated to splinting (n = 89 or surgery (n = 87. Clinical outcome measures included number of nights waking up due to symptoms, general improvement, severity of the main complaint, paraesthesia at night and during the day, and utility. The economic evaluation was performed from a societal perspective and involved all relevant costs. Results There were no differences in costs. The mean total costs per patient were in the surgery group EURO 2,126 compared to EURO 2,111 in the splint group. After 12 months, the success rate in the surgery group (92% was significantly higher than in the splint group (72%. The acceptability curve showed that at a relatively low ceiling ratio of EURO 2,500 per patient there is a 90% probability that surgery is cost-effective. Conclusion In the Netherlands, surgery is more cost-effective compared with splinting, and recommended as the preferred method of treatment for patients with CTS.

  2. The use of skin surface electropotentials for breast cancer detection--preliminary clinical trial results obtained using the biofield diagnostic system.

    Science.gov (United States)

    Sree, Subbhuraam Vinitha; Ng, E Y K; Kaw, G; U, Rajendra Acharya; Chong, B K

    2011-02-01

    The purpose of this study is to evaluate the efficiency of the Biofield Diagnostic System (BDS) as an adjunct to established diagnostic techniques such as mammography and ultrasound in differentiating benign and malignant breast lesions. The clinical trial was conducted at the Tan Tock Seng hospital, Singapore. 103 women scheduled for mammography and/or ultrasound tests participated in the study. The BDS test recorded a sensitivity of 100%, specificity of 97.6%, and an accuracy of 98.1%. The area under the ROC curve was 0.988 which was slightly lower than that of ultrasound (0.994) and slightly higher than that of mammography (0.951). The BDS test has demonstrated high sensitivity and specificity values in the studied population. The accuracy is also comparable to that of diagnostic techniques like mammography and ultrasound. Thus, it is evident that BDS can be a fast and reliable adjunct tool for getting a secondary opinion on lesions with indeterminate mammographic and sonographic results. PMID:20703583

  3. Comparison of Adding Treatment of PTSD During and After Shelter Stay to Standard Care in Residents of Battered Women's Shelters: Results of a Randomized Clinical Trial.

    Science.gov (United States)

    Johnson, Dawn M; Johnson, Nicole L; Perez, Sara K; Palmieri, Patrick A; Zlotnick, Caron

    2016-08-01

    This study explored the acceptability, feasibility, and initial efficacy of an expanded version of a PTSD treatment developed for residents of battered women's shelters, Helping to Overcome PTSD through Empowerment (HOPE) in women who received standard shelter services (SSSs). A Phase I randomized clinical trial comparing HOPE + SSSs (n = 30) to SSSs (n = 30) was conducted. Primary outcome measures included the Clinician-Administered PTSD Scale (Blake et al., 1995) and the Revised Conflict Tactic Scales (Straus, Hamby, Boney-McCoy, & Sugarman, ). Participants were followed at 1-week, and 3- and 6-months posttreatment. Only 2 women dropped out of HOPE + SSS treatment. Latent growth curve analyses found significant treatment effects for PTSD from intimate partner violence (IPV) (β = -.007, p = .021), but not for future IPV (β = .002, p = .709) across follow-up points. Significant effects were also found for secondary outcomes of depression severity (β = -.006, p = .052), empowerment (β = .155, p = .022), and resource gain (β = .158, p = .036). Additionally, more women in HOPE + SSSs were employed at 3- and 6-month follow-up compared to those in SSSs only. Results showed the acceptability and feasibility of adding IPV-related treatment to standard services. They also suggested that HOPE may be a promising treatment for residents of battered women's shelters. Further research with a larger sample, utilizing more diverse shelter settings and a more rigorous control condition, is needed to confirm these findings. PMID:27459503

  4. Accelerated Partial Breast Irradiation: 5-Year Results of the German-Austrian Multicenter Phase II Trial Using Interstitial Multicatheter Brachytherapy Alone After Breast-Conserving Surgery

    International Nuclear Information System (INIS)

    Purpose: To evaluate the impact of accelerated partial breast irradiation on local control, side effects, and cosmesis using multicatheter interstitial brachytherapy as the sole method for the adjuvant local treatment of patients with low-risk breast cancer. Methods and Materials: 274 patients with low-risk breast cancer were treated on protocol. Patients were eligible for the study if the tumor size was 35 years, hormone receptors were positive, and histologic grades were 1 or 2. Of the 274 patients, 175 (64%) received pulse-dose-rate brachytherapy (Dref = 50 Gy). and 99 (36%) received high-dose-rate brachytherapy (Dref = 32.0 Gy). Results: Median follow-up was 63 months (range, 9-103). Only 8 of 274 (2.9%) patients developed an ipsilateral in-breast tumor recurrence at the time of analysis. The 5-year actuarial local recurrence-free survival probability was 98%. The 5- year overall and disease-free survival probabilities of all patients were 97% and 96%, respectively. Contralateral in-breast malignancies were detected in 2 of 274 (0.7%) patients, and distant metastases occurred in 6 of 274 (2.2%). Late side effects ≥Grade 3 (i.e., breast tissue fibrosis and telangiectasia) occurred in 1 patient (0.4%, 95%CI:0.0-2.0%) and 6 patients (2.2%, 95%CI:0.8-4.7%), respectively. Cosmetic results were good to excellent in 245 of 274 patients (90%). Conclusions: The long-term results of this prospective Phase II trial confirm that the efficacy of accelerated partial breast irradiation using multicatheter brachytherapy is comparable with that of whole breast irradiation and that late side effects are negligible.

  5. Predicting the effect of maternal docosahexaenoic acid (DHA) supplementation to reduce early preterm birth in Australia and the United States using results of within country randomized controlled trials.

    Science.gov (United States)

    Yelland, L N; Gajewski, B J; Colombo, J; Gibson, R A; Makrides, M; Carlson, S E

    2016-09-01

    The DHA to Optimize Mother Infant Outcome (DOMInO) and Kansas DHA Outcomes Study (KUDOS) were randomized controlled trials that supplemented mothers with 800 and 600mg DHA/day, respectively, or a placebo during pregnancy. DOMInO was conducted in Australia and KUDOS in the United States. Both trials found an unanticipated and statistically significant reduction in early preterm birth (ePTB; i.e., birth before 34 weeks gestation). However, in each trial, the number of ePTBs were small. We used a novel Bayesian approach to estimate statistically derived low, moderate or high risk for ePTB, and to test for differences between the DHA and placebo groups. In both trials, the model predicted DHA would significantly reduce the expected proportion of deliveries in the high risk group under the trial conditions of the parent studies. Among the next 300,000 births in Australia we estimated that 1112 ePTB (95% credible interval 51-2189) could be avoided by providing DHA. And in the USA we estimated that 106,030 ePTB (95% credible interval 6400 to 175,700) could be avoided with DHA.

  6. Beneficial effects of citrus juice fermented with Lactobacillus plantarum YIT 0132 on atopic dermatitis: results of daily intake by adult patients in two open trials.

    Science.gov (United States)

    Harima-Mizusawa, Naomi; Kamachi, Keiko; Kano, Mitsuyoshi; Nozaki, Daisuke; Uetake, Tatsuo; Yokomizo, Yuji; Nagino, Takayuki; Tanaka, Akira; Miyazaki, Kouji; Nakamura, Shinichiro

    2016-01-01

    This study aimed to examine whether daily intake of citrus juice containing heat-killed Lactobacillus plantarum YIT 0132 (LP0132-fermented juice) alleviates symptoms of atopic dermatitis. This was a natural extension of our previous study in which LP0132 was shown to enhance IL-10 production in vitro and LP0132-fermented juice was found to alleviate symptoms and enhance quality of life (QOL) in patients with Japanese cedar pollinosis. In two open trials, Trial 1 and Trial 2, 32 and 18 adult patients with mild to moderate atopic dermatitis consumed LP0132-fermented juice for 8 weeks. Skin conditions and QOL were subjectively evaluated using Skindex-16 before intake of the juice (Pre-treatment), 8 weeks after starting intake (Treatment) and 8 weeks after termination of intake (Post-treatment). Blood parameters were also analyzed. Comparison of the Treatment and Post-treatment time points with the Pre-treatment time point revealed significant reductions in the Skindex-16 overall score and the 3 domain subscores (symptoms, emotions, and functioning domains) in both trials. Moreover, blood levels of eosinophil cationic protein (ECP), total immunoglobulin E (IgE) and specific IgEs for Japanese cedar and cypress pollen were significantly attenuated in Trial 2. The findings suggest that daily intake of citrus fermented juice containing heat-killed LP0132 has beneficial effects on symptoms and QOL in patients with mild to moderate atopic dermatitis due to an immunomodulatory effect via attenuation of IgE and ECP. PMID:26858928

  7. Predicting the effect of maternal docosahexaenoic acid (DHA) supplementation to reduce early preterm birth in Australia and the United States using results of within country randomized controlled trials.

    Science.gov (United States)

    Yelland, L N; Gajewski, B J; Colombo, J; Gibson, R A; Makrides, M; Carlson, S E

    2016-09-01

    The DHA to Optimize Mother Infant Outcome (DOMInO) and Kansas DHA Outcomes Study (KUDOS) were randomized controlled trials that supplemented mothers with 800 and 600mg DHA/day, respectively, or a placebo during pregnancy. DOMInO was conducted in Australia and KUDOS in the United States. Both trials found an unanticipated and statistically significant reduction in early preterm birth (ePTB; i.e., birth before 34 weeks gestation). However, in each trial, the number of ePTBs were small. We used a novel Bayesian approach to estimate statistically derived low, moderate or high risk for ePTB, and to test for differences between the DHA and placebo groups. In both trials, the model predicted DHA would significantly reduce the expected proportion of deliveries in the high risk group under the trial conditions of the parent studies. Among the next 300,000 births in Australia we estimated that 1112 ePTB (95% credible interval 51-2189) could be avoided by providing DHA. And in the USA we estimated that 106,030 ePTB (95% credible interval 6400 to 175,700) could be avoided with DHA. PMID:27637340

  8. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

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

    Directory of Open Access Journals (Sweden)

    Michielsen Kristien

    2012-09-01

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

  10. Phase II Trial of Radiotherapy After Hyperbaric Oxygenation With Multiagent Chemotherapy (Procarbazine, Nimustine, and Vincristine) for High-Grade Gliomas: Long-Term Results

    Energy Technology Data Exchange (ETDEWEB)

    Ogawa, Kazuhiko, E-mail: kogawa@med.u-ryukyu.ac.jp [Department of Radiology, University of the Ryukyus, Okinawa (Japan); Ishiuchi, Shogo [Department of Neurosurgery, University of the Ryukyus, Okinawa (Japan); Inoue, Osamu [Department of Hyperbaric Medicine, University of the Ryukyus, Okinawa (Japan); Yoshii, Yoshihiko [Department of Neurosurgery, University of the Ryukyus, Okinawa (Japan); Department of Neurosurgery, Tsukuba Memorial Hospital, Tsukuba (Japan); Saito, Atsushi [Department of Neurosurgery, University of the Ryukyus, Okinawa (Japan); Department of Neurosurgery, Tsukuba Medical Center Hospital, Tsukuba (Japan); Watanabe, Takashi [Department of Neurosurgery, University of the Ryukyus, Okinawa (Japan); Iraha, Shiro [Department of Radiology, Okinawa South Medical Center, Okinawa (Japan); Department of Radiology, University of the Ryukyus, Okinawa (Japan); Toita, Takafumi; Kakinohana, Yasumasa; Ariga, Takuro; Kasuya, Goro; Murayama, Sadayuki [Department of Radiology, University of the Ryukyus, Okinawa (Japan)

    2012-02-01

    Purpose: To analyze the long-term results of a Phase II trial of radiotherapy given immediately after hyperbaric oxygenation (HBO) with multiagent chemotherapy in adults with high-grade gliomas. Methods and Materials: Patients with histologically confirmed high-grade gliomas were administered radiotherapy in daily 2 Gy fractions for 5 consecutive days per week up to a total dose of 60 Gy. Each fraction was administered immediately after HBO, with the time interval from completion of decompression to start of irradiation being less than 15 minutes. Chemotherapy consisting of procarbazine, nimustine, and vincristine and was administered during and after radiotherapy. Results: A total of 57 patients (39 patients with glioblastoma and 18 patients with Grade 3 gliomas) were enrolled from 2000 to 2006, and the median follow-up of 12 surviving patients was 62.0 months (range, 43.2-119.1 months). All 57 patients were able to complete a total radiotherapy dose of 60 Gy immediately after HBO with one course of concurrent chemotherapy. The median overall survival times in all 57 patients, 39 patients with glioblastoma and 18 patients with Grade 3 gliomas, were 20.2 months, 17.2 months, and 113.4 months, respectively. On multivariate analysis, histologic grade alone was a significant prognostic factor for overall survival (p < 0.001). During treatments, no patients had neutropenic fever or intracranial hemorrhage, and no serious nonhematologic or late toxicities were seen in any of the 57 patients. Conclusions: Radiotherapy delivered immediately after HBO with multiagent chemotherapy was safe, with virtually no late toxicities, and seemed to be effective in patients with high-grade gliomas.

  11. Phase II Trial of Radiotherapy After Hyperbaric Oxygenation With Multiagent Chemotherapy (Procarbazine, Nimustine, and Vincristine) for High-Grade Gliomas: Long-Term Results

    International Nuclear Information System (INIS)

    Purpose: To analyze the long-term results of a Phase II trial of radiotherapy given immediately after hyperbaric oxygenation (HBO) with multiagent chemotherapy in adults with high-grade gliomas. Methods and Materials: Patients with histologically confirmed high-grade gliomas were administered radiotherapy in daily 2 Gy fractions for 5 consecutive days per week up to a total dose of 60 Gy. Each fraction was administered immediately after HBO, with the time interval from completion of decompression to start of irradiation being less than 15 minutes. Chemotherapy consisting of procarbazine, nimustine, and vincristine and was administered during and after radiotherapy. Results: A total of 57 patients (39 patients with glioblastoma and 18 patients with Grade 3 gliomas) were enrolled from 2000 to 2006, and the median follow-up of 12 surviving patients was 62.0 months (range, 43.2–119.1 months). All 57 patients were able to complete a total radiotherapy dose of 60 Gy immediately after HBO with one course of concurrent chemotherapy. The median overall survival times in all 57 patients, 39 patients with glioblastoma and 18 patients with Grade 3 gliomas, were 20.2 months, 17.2 months, and 113.4 months, respectively. On multivariate analysis, histologic grade alone was a significant prognostic factor for overall survival (p < 0.001). During treatments, no patients had neutropenic fever or intracranial hemorrhage, and no serious nonhematologic or late toxicities were seen in any of the 57 patients. Conclusions: Radiotherapy delivered immediately after HBO with multiagent chemotherapy was safe, with virtually no late toxicities, and seemed to be effective in patients with high-grade gliomas.

  12. The Efficacy of Two Adolescent Substance Abuse Treatments and the Impact of Comorbid Depression: Results of a Small Randomized Controlled Trial

    Science.gov (United States)

    Santisteban, Daniel A.; Mena, Maite P.; Muir, Joan; McCabe, Brian E.; Abalo, Clara; Cummings, Amanda M.

    2016-01-01

    Objective The purpose of this randomized trial was to investigate the efficacy of two behavioral treatments focusing on different change mechanisms in ameliorating a borderline personality disorder constellation of behaviors and substance use in adolescents referred by juvenile diversion programs. Methods Forty adolescents 14 to 17 years of age and meeting DSM IV criteria for borderline personality disorder and substance use disorders were randomized to Integrative Borderline Personality Disorder-Oriented Adolescent Family Therapy (I-BAFT) or Individual Drug Counseling (IDC). This design allowed a comparison of two manualized interventions, one family-based and one individually-oriented. Profiles of clinical change were used to detect impact and to estimate treatment effect sizes. Results Primary analyses showed that both interventions had a clinically significant impact on borderline personality disorder behaviors 12 months after baseline but with no differential treatment effects. The impact on substance use was more complex. Subgroup analyses revealed that adolescents with depression had significantly more severe profiles of borderline personality disorder and substance use. These youth were the only group to show reductions in substance use, but only if they received the I-BAFT intervention. Study data also documented the high dosage of intensive residential treatment needed by this population. Conclusions and Implications for Practice Results highlight the intensive treatment needs of juvenile justice involved youth with co-occurring substance use and borderline personality disorder including depression, the hybrid outpatient and residential treatment often required by this population, and the promise of a family oriented approach particularly for youth with severe symptoms and co-occurring depression. PMID:25799306

  13. Long-acting somatostatin analogues provide significant beneficial effect in patients with refractory small bowel angiodysplasia: Results from a proof of concept open label mono-centre trial

    Science.gov (United States)

    Hall, Barry; Breslin, Niall; McNamara, Deirdre

    2015-01-01

    Introduction Small bowel angiodysplasias account for over 50% of causes of small bowel bleeding and carry a worse prognosis than lesions located elsewhere in the gastrointestinal tract. Re-bleeding rates are high even after first-line endoscopic therapy and are associated with high levels of morbidity for affected patients. Small trials of long-acting somatostatin analogues have shown promising results but have not yet been assessed in patients with refractory small bowel disease. Aim The purpose of this study was to assess the effect of long-acting somatostatin analogues in reducing re-bleeding rates and transfusion requirements, and improving haemoglobin levels in patients with refractory small bowel angiodysplasia. Methods Patients with refractory small bowel angiodysplasia were treated with 20 mg of long-acting octreotide for a minimum of three months. Response was assessed according to: rates of re-bleeding, haemoglobin levels, transfusion requirements, and side effects. Results A total of 24 patients were initially treated and 20 received at least three doses. Rates of complete, partial and non-response were 70%, 20% and 10% respectively. Average haemoglobin rates increased from 9.19 g/dl to 11.35 g/dl (p = 0.0027, 95% confidence interval (CI) −3.5 to −1.1) in the group overall and 70% remained transfusion-free after a mean treatment duration of 8.8 months. The rate of adverse events was higher than previously reported at 30%. Conclusion Long-acting somatostatin analogues offer a therapeutic advantage in a significant proportion of patients with small bowel angiodysplasia. With careful patient selection and close observation, a long-acting somatostatin analogue should be considered in all patients with persistent anaemia attributable to refractory disease in conjunction with other standard treatments. PMID:26966525

  14. The effect of a combination of gabapentin and donepezil in an experimental pain model in healthy volunteers: Results of a randomized controlled trial.

    Science.gov (United States)

    Boyle, Yvonne; Fernando, Disala; Kurz, Hazel; Miller, Sam R; Zucchetto, Mauro; Storey, James

    2014-12-01

    This double-blind, placebo-controlled, 3-period cross-over, 4-treatment option, incomplete block study (ClinicalTrials.gov number NCT01485185), with an adaptive design for sample size re-estimation, was designed to evaluate gabapentin plus donepezil in an established experimental model of electrical hyperalgesia. Thirty healthy male subjects aged 18-55 years were randomized to receive gabapentin 900 mg or gabapentin 900 mg+donepezil 5mg for 2 of the 3 treatment periods, with 50% of subjects randomized to receive placebo (negative control) and 50% to gabapentin 1800 mg (positive control) for the remaining period. Each treatment period was 14 days. Gabapentin or corresponding placebo was administered on Day 13 and the morning of Day 14. Donepezil or corresponding placebo was administered nocturnally from Day 1-13 and the morning of Day 14. Co-primary endpoints were the area of pinprick hyperalgesia (260 mN von Frey filament) and allodynia (stroking by cotton bud) evoked by electrical hyperalgesia on Day 14. Gabapentin 1800 mg (n=14) significantly reduced the area of allodynia vs placebo (n=14; -12.83 cm(2); 95% confidence interval [CI] -23.14 to -2.53; P=0.015) with supportive results for hyperalgesia (-14.04 cm(2); 95% CI -28.49-0.41; P=0.057), validating the electrical hyperalgesia model. Gabapentin+donepezil (n=30) significantly reduced the area of hyperalgesia vs gabapentin 900 mg (n=30; -11.73 cm(2); 95% CI -21.04 to -2.42; P=0.014), with supportive results for allodynia (-6.62 cm(2); 95% CI -13.29-0.04; P=0.052). The adverse event profile for gabapentin+donepezil was similar to the same dose of gabapentin. Data are supportive of further clinical investigation of a gabapentin-and-donepezil combination in patients with an inadequate response to gabapentin.

  15. An open pilot study of zonisamide augmentation in major depressive patients not responding to a low dose trial with duloxetine: preliminary results on tolerability and clinical effects

    Directory of Open Access Journals (Sweden)

    Benvenuti Marzia

    2011-09-01

    Full Text Available Abstract Background Despite multiple antidepressant options, major depressive disorder (MDD still faces high non-response rates, eventually requiring anticonvulsant augmentation strategies too. The aim of this study was to explore such a potential role for zonisamide. Methods A total of 40 MDD outpatients diagnosed using the Diagnostic and Statistical Manual for Mental Disorders, fourth edition criteria entered a 24 week open trial receiving duloxetine 60 mg/day for the first 12 weeks and subsequently (weeks 12 to 24 augmentation with zonisamide 75 mg/day if they did not respond to the initial monotherapy. Efficacy and tolerability were assessed using the Hamilton Scales for Anxiety and Depression (a 12 week score ≥50% vs baseline defined 'non-response', the Arizona Sexual Experience Scale, the Patient Rated Inventory of Side Effects and the Young Mania Rating Scale. Results At week 12, 15 patients out of 39 (38.5% were responders, and 1 had dropped out; remarkably, 14 patients out of 24 (58.3% had achieved response by week 24. Poor concentration and general malaise were associated with non-response both at week 12 and 24 (P = 0.001, while loss of libido and reduced energy were prominent among final timepoint non-responders. Patients receiving zonisamide also experienced weight reduction (2.09 ± 12.14 kg; P = 0.001 independently of the outcome. Conclusions Although only a preliminary study due to strong methodological limitations, and thus requiring confirmation by further controlled investigations, the current results indicate zonisamide may be a potential augmentation option for some depressed patients receiving low doses of duloxetine.

  16. HIV gender-based vulnerabilities of women using drugs in long-term heterosexual relationships: baseline results from a randomized trial in Ukraine

    Directory of Open Access Journals (Sweden)

    Shulga, Liudmyla

    2012-07-01

    Full Text Available BACKGROUND: Sexual way of HIV transmission in Ukraine outweighs parenteral route since 2007. In response to situation change couple’s counseling for IDUs was introduced and is currently tested within randomized trial.METHODS: Baseline data were collected in June-September 2011: 548 IDU couples in 10 cities were surveyed and screened for HIV and Hepatitis C. Participants were recruited using respondent-driven sampling method. RESULTS: The average age of participants varied between 30 – 33 years old with women being 3 years younger. On many aspects drug using couples in long-term relationships share the same values as non-drug using couples. However, drug use resulted into specific HIV/STIs risks for the couple. Common reasons of being with the current partner included mutual understanding (98%; similar life styles (90%; understanding life with addiction (88%; and love (87%. At the same time, looking at the quality time partners spend together, it was found that mostly, they are connected by their drug use, fear of social exclusion and economical reasons. Although these factors are important for both men and women, they have a bigger impact on women and put them into more vulnerable position: 25% have children who in 59% of cases mostly live with mother and her partner; 40% live in a partner’s house; 30% are financially supported by partners; 77% women get drugs from partners and only 20% are first one to be injected. Trust also seems to be an issue. Thus, 83% of respondents believe that they know the HIV/STI status of their partner and 90% of those believe it to be negative, while 20% of those surveyed appeared to be HIV positive and about 30% Hepatitis C positive. CONCLUSIONS: Understanding characteristics of sexual partners is crucial for HIV prevention programme design and implementation.

  17. Acute Toxicity Profile and Compliance to Accelerated Radiotherapy Plus Carbogen and Nicotinamide for Clinical Stage T2–4 Laryngeal Cancer: Results of a Phase III Randomized Trial

    International Nuclear Information System (INIS)

    Purpose: To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer. Methods and Materials: From April 2001 to February 2008, 345 patients with cT2–4 squamous cell laryngeal cancer were randomized to AR (n = 174) and ARCON (n = 171). Acute toxicity was scored weekly until Week 8 and every 2–4 weeks thereafter. Compliance to carbogen and nicotinamide was reported. Results: Between both treatment arms (AR vs. ARCON) no statistically significant difference was observed for incidence of acute skin reactions (moist desquamation: 56% vs. 58%, p = 0.80), acute mucosal reactions (confluent mucositis: 79% vs. 85%, p = 0.14), and symptoms related to acute mucositis (severe pain on swallowing: 53% vs. 58%, p = 0.37; nasogastric tube feeding: 28% vs. 28%, p = 0.98; narcotic medicines required: 58% vs. 58%, p = 0.97). There was a statistically significant difference in median duration of confluent mucositis in favor of AR (2.0 vs 3.0 weeks, p = 0.01). There was full compliance with carbogen breathing and nicotinamide in 86% and 80% of the patients, with discontinuation in 6% and 12%, respectively. Adjustment of antiemesis prophylaxis was needed in 42% of patients. Conclusion: With the exception of a slight increase in median duration of acute confluent mucositis, the present data reveal a similar acute toxicity profile between both regimens and a good compliance with ARCON for clinical stage T2–4 laryngeal cancers. Treatment outcome and late morbidity will determine the real therapeutic benefit.

  18. 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.

  19. The cardiovascular health of urban African Americans: diet-related results from the Genes, Nutrition, Exercise, Wellness, and Spiritual Growth (GoodNEWS) trial.

    Science.gov (United States)

    Carson, Jo Ann S; Michalsky, Linda; Latson, Bernadette; Banks, Kamakki; Tong, Liyue; Gimpel, Nora; Lee, Jenny J; Dehaven, Mark J

    2012-11-01

    African Americans have a higher incidence of cardiovascular disease (CVD) than Americans in general and are thus prime targets for efforts to reduce CVD risk. Dietary intake data were obtained from African Americans participating in the Genes, Nutrition, Exercise, Wellness, and Spiritual Growth (GoodNEWS) Trial. The 286 women and 75 men who participated had a mean age of 49 years; 53% had hypertension, 65% had dyslipidemia, and 51% met criteria for metabolic syndrome. Their dietary intakes were compared with American Heart Association and National Heart, Lung, and Blood Institute nutrition parameters to identify areas for improvement to reduce CVD risk in this group of urban church members in Dallas, TX. Results from administration of the Dietary History Questionnaire indicated median daily intakes of 33.6% of energy from total fat, 10.3% of energy from saturated fat, 171 mg cholesterol, 16.3 g dietary fiber, and 2,453 mg sodium. A beneficial median intake of 2.9 cups fruits and vegetables per day was coupled with only 2.7 oz fish/week and an excessive intake of 13 tsp added sugar/day. These data indicate several changes needed to bring the diets of these individuals--and likely many other urban African Americans--in line with national recommendations, including reduction of saturated fat, sodium, and sugar intake, in addition to increased intake of fatty fish and whole grains. The frequent inclusion of vegetables should be encouraged in ways that promote achievement of recommended intakes of energy, fat, fiber, and sodium.

  20. Gender affects acute organ toxicity during radiochemotherapy for rectal cancer: Long-term results of the German CAO/ARO/AIO-94 phase III trial

    International Nuclear Information System (INIS)

    Introduction: The CAO/ARO/AIO-94 phase-III-trial demonstrated a significant improvement of preoperative chemoradiotherapy (CRT) versus postoperative CRT on local control for UICC stage II/III rectal cancer patients, but no effect on long-term survival. In this add-on evaluation, we investigated the association of gender and age with acute toxicity and outcome. Patients and methods: According to actual treatment analyses, 654 of 799 patients had received pre- (n = 406) or postoperative CRT (n = 248); in 145 patients postoperative CRT was not applied. Gender, age and clinicopathological parameters were correlated with CRT-associated acute toxicity and survival. Results: The 10-year survival was higher in women than in men, with 72.4% versus 65.6% for time to recurrence (p = 0.088) and 62.7% versus 58.4% for overall-survival (OS) (p = 0.066), as expected. For patients receiving CRT, women showed higher hematologic (p < 0.001) and acute organ toxicity (p < 0.001) in the entire cohort as well as in subgroup analyses according to pre- (p = 0.016) and postoperative CRT (p < 0.001). Lowest OS was seen in patients without acute toxicity (p = 0.0271). Multivariate analyses for OS showed that acute organ toxicity (p = 0.034) was beneficial while age (p < 0.001) was associated with worse OS. Discussion: Female gender is significantly associated with CRT-induced acute toxicity in rectal cancer. Acute toxicity during CRT may be associated with improved long-term outcome

  1. Health-Related Quality of Life After Stereotactic Body Radiation Therapy for Localized Prostate Cancer: Results From a Multi-institutional Consortium of Prospective Trials

    Energy Technology Data Exchange (ETDEWEB)

    King, Christopher R., E-mail: crking@mednet.ucla.edu [Department of Radiation Oncology, University of California, Los Angeles, California (United States); Collins, Sean [Department of Radiation Oncology, Georgetown University, Washington, District of Columbia (United States); Fuller, Donald [Genesis Healthcare Partners, San Diego, California (United States); Wang, Pin-Chieh; Kupelian, Patrick; Steinberg, Michael [Department of Radiation Oncology, University of California, Los Angeles, California (United States); Katz, Alan [Flushing Radiation Oncology, Flushing, New York (United States)

    2013-12-01

    Purpose: To evaluate the early and late health-related quality of life (QOL) outcomes among prostate cancer patients following stereotactic body radiation therapy (SBRT). Methods and Materials: Patient self-reported QOL was prospectively measured among 864 patients from phase 2 clinical trials of SBRT for localized prostate cancer. Data from the Expanded Prostate Cancer Index Composite (EPIC) instrument were obtained at baseline and at regular intervals up to 6 years. SBRT delivered a median dose of 36.25 Gy in 4 or 5 fractions. A short course of androgen deprivation therapy was given to 14% of patients. Results: Median follow-up was 3 years and 194 patients remained evaluable at 5 years. A transient decline in the urinary and bowel domains was observed within the first 3 months after SBRT which returned to baseline status or better within 6 months and remained so beyond 5 years. The same pattern was observed among patients with good versus poor baseline function and was independent of the degree of early toxicities. Sexual QOL decline was predominantly observed within the first 9 months, a pattern not altered by the use of androgen deprivation therapy or patient age. Conclusion: Long-term outcome demonstrates that prostate SBRT is well tolerated and has little lasting impact on health-related QOL. A transient and modest decline in urinary and bowel QOL during the first few months after SBRT quickly recovers to baseline levels. With a large number of patients evaluable up to 5 years following SBRT, it is unlikely that unexpected late adverse effects will manifest themselves.

  2. The effects of a 25% discount on fruits and vegetables: results of a randomized trial in a three-dimensional web-based supermarket

    Science.gov (United States)

    2012-01-01

    Background Lowering the price of fruit and vegetables is a promising strategy in stimulating the purchase of those foods. However, the true effects of this strategy are not well studied and it is unclear how the money saved is spent. The aim of this study is to examine the effects of a 25% discount on fruits and vegetables on food purchases in a supermarket environment. Methods A randomized controlled trial with two research conditions was conducted: a control condition with regular prices (n = 52) and an experimental condition with a 25% discount on fruits and vegetables (n = 63). The experiment was carried out using a three-dimensional web-based supermarket, which is a software application in the image of a real supermarket. Data were collected in 2010 in the Netherlands. Participants received a fixed budget and were asked to buy weekly household groceries at the web-based supermarket. Differences in fruit and vegetable purchases, differences in expenditures in other food categories and differences in total calories were analyzed using independent samples t-tests and multiple linear regression models accounting for potential effect modifiers and confounders. Results The purchased amount of fruit plus vegetables was significantly higher in the experimental condition compared to the control condition (Δ984 g per household per week, p = .03) after appropriate adjustments. This corresponds to a 25% difference compared to the control group. Both groups had similar expenditures in unhealthier food categories, including desserts, soda, crisps, candy and chocolate. Furthermore, both groups purchased an equal number of food items and an equal amount of calories, indicating that participants in the discount condition did not spend the money they saved from the discounts on other foods than fruits and vegetables. Conclusion A 25% discount on fruits and vegetables was effective in stimulating purchases of those products and did neither lead to higher expenditures in

  3. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial

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    Aigner Julia

    2010-10-01

    Full Text Available Abstract Background We compared the healing response of tibial delayed unions between subjects treated with low-intensity pulsed ultrasound (LIPUS (n = 51 and subjects treated with a sham device (n = 50. Fracture age was ≥ 4 months in all cases. Study personnel and participants were blinded to random treatment assignment throughout the study. Methods This multi-center randomized sham-controlled trial was undertaken at six hospitals in Germany. Adult patients who had sustained a tibial shaft fracture that subsequently showed inadequate progress toward healing (i.e., delayed union were enrolled and randomized to receive either LIPUS (Exogen 2000/2000+, Smith & Nephew GmbH, Schenefeld, Germany or an identical nonoperative sham device. The daily treatment duration was 20 minutes, for a period of 16 weeks. Subjects randomly assigned to active treatment had the ultrasound pressure wave signal set at the following parameters: 1.5 MHz frequency, 1 kHz repetition rate, 200 μs pulse duration, 30 mW/cm2 spatial intensity. Progress toward healing was estimated from changes in bone mineral density (BMD and gap area as determined from computed tomography scans. Intention-to-treat analysis was conducted using a multiple imputation methodology. Results Based on log-transformed data, mean improvement in BMD was 1.34 (90% confidence interval (CI 1.14 to 1.57 times greater for LIPUS-treated subjects compared to sham (p = 0.002. A mean reduction in bone gap area also favored LIPUS treatment (p = 0.014. Conclusions These findings demonstrate significantly greater progress toward bone healing after LIPUS treatment compared to no LIPUS treatment in subjects with established delayed unions of the tibia.

  4. Acute Toxicity Profile and Compliance to Accelerated Radiotherapy Plus Carbogen and Nicotinamide for Clinical Stage T2-4 Laryngeal Cancer: Results of a Phase III Randomized Trial

    Energy Technology Data Exchange (ETDEWEB)

    Janssens, Geert O., E-mail: g.janssens@rther.umcn.nl [Department of Radiation Oncology, Radboud University Nijmegen Medical Centre, Nijmegen (Netherlands); Terhaard, Chris H. [Department of Radiation Oncology, University Medical Center Utrecht, Utrecht (Netherlands); Doornaert, Patricia A. [Department of Radiation Oncology, VU University Medical Center, Amsterdam (Netherlands); Bijl, Hendrik P. [Department of Radiation Oncology, University Medical Center Groningen, Groningen (Netherlands); Ende, Piet van den [Department of Radiation Oncology, Maastricht University Medical Centre, Maastricht (Netherlands); Chin, Alim [Department of Clinical Oncology, Leiden University Medical Centre, Leiden (Netherlands); Pop, Lucas A.; Kaanders, Johannes H. [Department of Radiation Oncology, Radboud University Nijmegen Medical Centre, Nijmegen (Netherlands)

    2012-02-01

    Purpose: To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer. Methods and Materials: From April 2001 to February 2008, 345 patients with cT2-4 squamous cell laryngeal cancer were randomized to AR (n = 174) and ARCON (n = 171). Acute toxicity was scored weekly until Week 8 and every 2-4 weeks thereafter. Compliance to carbogen and nicotinamide was reported. Results: Between both treatment arms (AR vs. ARCON) no statistically significant difference was observed for incidence of acute skin reactions (moist desquamation: 56% vs. 58%, p = 0.80), acute mucosal reactions (confluent mucositis: 79% vs. 85%, p = 0.14), and symptoms related to acute mucositis (severe pain on swallowing: 53% vs. 58%, p = 0.37; nasogastric tube feeding: 28% vs. 28%, p = 0.98; narcotic medicines required: 58% vs. 58%, p = 0.97). There was a statistically significant difference in median duration of confluent mucositis in favor of AR (2.0 vs 3.0 weeks, p = 0.01). There was full compliance with carbogen breathing and nicotinamide in 86% and 80% of the patients, with discontinuation in 6% and 12%, respectively. Adjustment of antiemesis prophylaxis was needed in 42% of patients. Conclusion: With the exception of a slight increase in median duration of acute confluent mucositis, the present data reveal a similar acute toxicity profile between both regimens and a good compliance with ARCON for clinical stage T2-4 laryngeal cancers. Treatment outcome and late morbidity will determine the real therapeutic benefit.

  5. Yield and economic performance of organic and conventional cotton-based farming systems--results from a field trial in India.

    Science.gov (United States)

    Forster, Dionys; Andres, Christian; Verma, Rajeev; Zundel, Christine; Messmer, Monika M; Mäder, Paul

    2013-01-01

    The debate on the relative benefits of conventional and organic farming systems has in recent time gained significant interest. So far, global agricultural development has focused on increased productivity rather than on a holistic natural resource management for food security. Thus, developing more sustainable farming practices on a large scale is of utmost importance. However, information concerning the performance of farming systems under organic and conventional management in tropical and subtropical regions is scarce. This study presents agronomic and economic data from the conversion phase (2007-2010) of a farming systems comparison trial on a Vertisol soil in Madhya Pradesh, central India. A cotton-soybean-wheat crop rotation under biodynamic, organic and conventional (with and without Bt cotton) management was investigated. We observed a significant yield gap between organic and conventional farming systems in the 1(st) crop cycle (cycle 1: 2007-2008) for cotton (-29%) and wheat (-27%), whereas in the 2(nd) crop cycle (cycle 2: 2009-2010) cotton and wheat yields were similar in all farming systems due to lower yields in the conventional systems. In contrast, organic soybean (a nitrogen fixing leguminous plant) yields were marginally lower than conventional yields (-1% in cycle 1, -11% in cycle 2). Averaged across all crops, conventional farming systems achieved significantly higher gross margins in cycle 1 (+29%), whereas in cycle 2 gross margins in organic farming systems were significantly higher (+25%) due to lower variable production costs but similar yields. Soybean gross margin was significantly higher in the organic system (+11%) across the four harvest years compared to the conventional systems. Our results suggest that organic soybean production is a viable option for smallholder farmers under the prevailing semi-arid conditions in India. Future research needs to elucidate the long-term productivity and profitability, particularly of cotton and

  6. Yield and economic performance of organic and conventional cotton-based farming systems--results from a field trial in India.

    Directory of Open Access Journals (Sweden)

    Dionys Forster

    Full Text Available The debate on the relative benefits of conventional and organic farming systems has in recent time gained significant interest. So far, global agricultural development has focused on increased productivity rather than on a holistic natural resource management for food security. Thus, developing more sustainable farming practices on a large scale is of utmost importance. However, information concerning the performance of farming systems under organic and conventional management in tropical and subtropical regions is scarce. This study presents agronomic and economic data from the conversion phase (2007-2010 of a farming systems comparison trial on a Vertisol soil in Madhya Pradesh, central India. A cotton-soybean-wheat crop rotation under biodynamic, organic and conventional (with and without Bt cotton management was investigated. We observed a significant yield gap between organic and conventional farming systems in the 1(st crop cycle (cycle 1: 2007-2008 for cotton (-29% and wheat (-27%, whereas in the 2(nd crop cycle (cycle 2: 2009-2010 cotton and wheat yields were similar in all farming systems due to lower yields in the conventional systems. In contrast, organic soybean (a nitrogen fixing leguminous plant yields were marginally lower than conventional yields (-1% in cycle 1, -11% in cycle 2. Averaged across all crops, conventional farming systems achieved significantly higher gross margins in cycle 1 (+29%, whereas in cycle 2 gross margins in organic farming systems were significantly higher (+25% due to lower variable production costs but similar yields. Soybean gross margin was significantly higher in the organic system (+11% across the four harvest years compared to the conventional systems. Our results suggest that organic soybean production is a viable option for smallholder farmers under the prevailing semi-arid conditions in India. Future research needs to elucidate the long-term productivity and profitability, particularly of cotton

  7. 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.

  8. Clofarabine salvage therapy before allogeneic hematopoietic stem cell transplantation in patients with relapsed or refractory AML: results of the BRIDGE trial.

    Science.gov (United States)

    Middeke, J M; Herbst, R; Parmentier, S; Bug, G; Hänel, M; Stuhler, G; Schäfer-Eckart, K; Rösler, W; Klein, S; Bethge, W; Bitz, U; Büttner, B; Knoth, H; Alakel, N; Schaich, M; Morgner, A; Kramer, M; Sockel, K; von Bonin, M; Stölzel, F; Platzbecker, U; Röllig, C; Thiede, C; Ehninger, G; Bornhäuser, M; Schetelig, J

    2016-02-01

    In patients with relapsed or refractory (r/r) acute myeloid leukemia (AML), long-term disease control can only be achieved by allogeneic hematopoietic stem cell transplantation (HSCT). We studied the safety and efficacy of clofarabine-based salvage therapy. The study was designed as phase II, multicenter, intent-to-transplant (ITT) study. A total of 84 patients with r/r AML were enrolled. All patients received at least one cycle of CLARA (clofarabine 30 mg/m(2) and cytarabine 1 g/m(2), days 1-5). Chemo-responsive patients with a donor received HSCT in aplasia after first CLARA. Generally, HSCT was performed as soon as possible. The conditioning regimen consisted of clofarabine (4 × 30 mg/m(2)) and melphalan (140 mg/m(2)). The median patient age was 61 years (range 40-75). On day 15 after start of CLARA, 26% of patients were in a morphologically leukemia-free state and 79% exposed a reduction in bone marrow blasts. Overall, 67% of the patients received HSCT within the trial. The primary end point, defined as complete remission after HSCT, was achieved by 60% of the patients. According to the ITT, overall survival at 2 years was 43% (95% confidence interval (CI), 32-54%). The 2-year disease-free survival for transplanted patients was 52% (95% CI, 40-69%). Clofarabine-based salvage therapy combined with allogeneic HSCT in aplasia shows promising results in patients with r/r AML. PMID:26283567

  9. Stereotactic hypofractionated accurate radiotherapy of the prostate (SHARP), 33.5 Gy in five fractions for localized disease: First clinical trial results

    International Nuclear Information System (INIS)

    Purpose: To evaluate the feasibility and toxicity of stereotactic hypofractionated accurate radiotherapy (SHARP) for localized prostate cancer. Methods and Materials: A Phase I/II trial of SHARP performed for localized prostate cancer using 33.5 Gy in 5 fractions, calculated to be biologically equivalent to 78 Gy in 2 Gy fractions (α/β ratio of 1.5 Gy). Noncoplanar conformal fields and daily stereotactic localization of implanted fiducials were used for treatment. Genitourinary (GU) and gastrointestinal (GI) toxicity were evaluated by American Urologic Association (AUA) score and Common Toxicity Criteria (CTC). Prostate-specific antigen (PSA) values and self-reported sexual function were recorded at specified follow-up intervals. Results: The study includes 40 patients. The median follow-up is 41 months (range, 21-60 months). Acute toxicity Grade 1-2 was 48.5% (GU) and 39% (GI); 1 acute Grade 3 GU toxicity. Late Grade 1-2 toxicity was 45% (GU) and 37% (GI). No late Grade 3 or higher toxicity was reported. Twenty-six patients reported potency before therapy; 6 (23%) have developed impotence. Median time to PSA nadir was 18 months with the majority of nadirs less than 1.0 ng/mL. The actuarial 48-month biochemical freedom from relapse is 70% for the American Society for Therapeutic Radiology and Oncology definition and 90% by the alternative nadir + 2 ng/mL failure definition. Conclusions: SHARP for localized prostate cancer is feasible with minimal acute or late toxicity. Dose escalation should be possible

  10. Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients: Primary Results from the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial

    Science.gov (United States)

    Bostom, Andrew G.; Carpenter, Myra A.; Kusek, John W.; Levey, Andrew S.; Hunsicker, Lawrence; Pfeffer, Marc A.; Selhub, Jacob; Jacques, Paul F.; Cole, Edward; Gravens-Mueller, Lisa; House, Andrew A.; Kew, Clifton; McKenney, Joyce L.; Pacheco-Silva, Alvaro; Pesavento, Todd; Pirsch, John; Smith, Stephen; Solomon, Scott; Weir, Matthew

    2015-01-01

    Background Kidney transplant recipients, like other patients with chronic kidney disease (CKD), experience excess risk of cardiovascular disease (CVD) and elevated total homocysteine (tHcy) concentrations. Observational studies of patients with CKD suggest increased homocysteine is a risk factor for CVD. The impact of lowering total homocysteine (tHcy) levels in kidney transplant recipients is unknown. Methods and Results In a double-blind controlled trial, we randomized 4110 stable kidney transplant recipients to a multivitamin that included either a high dose (n=2056) or low dose (n=2054) of folic acid, vitamin B6, and vitamin B12 to determine whether decreasing tHcy concentrations reduced the rate of the primary composite arteriosclerotic CVD outcome (myocardial infarction, stroke, CVD death, resuscitated sudden death, coronary artery or renal artery revascularization, lower extremity arterial disease, carotid endarterectomy or angioplasty, or abdominal aortic aneurysm repair). Mean follow-up was 4.0 years. Treatment with the high dose multivitamin reduced homocysteine but did not reduce the rates of the primary outcome (n= 547 total events; hazards ratio [95% confidence interval] = 0.99 [0.84–1.17]), or secondary outcomes of all-cause mortality (n=431 deaths; 1.04 [0.86–1.26]) or dialysis-dependent kidney failure (n=343 events; 1.15 [0.93–1.43]) compared to the low dose multivitamin. Conclusions Treatment with a high dose folic acid, B6, and B12 multivitamin in kidney transplant recipients did not reduce a composite cardiovascular disease outcome, all-cause mortality, or dialysis-dependent kidney failure despite significant reduction in homocysteine level. PMID:21482964

  11. Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial.

    Science.gov (United States)

    Santagostino, Elena; Martinowitz, Uri; Lissitchkov, Toshko; Pan-Petesch, Brigitte; Hanabusa, Hideji; Oldenburg, Johannes; Boggio, Lisa; Negrier, Claude; Pabinger, Ingrid; von Depka Prondzinski, Mario; Altisent, Carmen; Castaman, Giancarlo; Yamamoto, Koji; Álvarez-Roman, Maria-Teresa; Voigt, Christine; Blackman, Nicole; Jacobs, Iris

    2016-04-01

    A global phase 3 study evaluated the pharmacokinetics, efficacy, and safety of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in 63 previously treated male patients (12-61 years) with severe hemophilia B (factor IX [FIX] activity ≤2%). The study included 2 groups: group 1 patients received routine prophylaxis once every 7 days for 26 weeks, followed by either 7-, 10-, or 14-day prophylaxis regimen for a mean of 50, 38, or 51 weeks, respectively; group 2 patients received on-demand treatment of bleeding episodes for 26 weeks and then switched to a 7-day prophylaxis regimen for a mean of 45 weeks. The mean terminal half-life of rIX-FP was 102 hours, 4.3-fold longer than previous FIX treatment. Patients maintained a mean trough of 20 and 12 IU/dL FIX activity on prophylaxis with rIX-FP 40 IU/kg weekly and 75 IU/kg every 2 weeks, respectively. There was 100% reduction in median annualized spontaneous bleeding rate (AsBR) and 100% resolution of target joints when subjects switched from on-demand to prophylaxis treatment with rIX-FP (P< .0001). The median AsBR was 0.00 for all prophylaxis regimens. Overall, 98.6% of bleeding episodes were treated successfully, including 93.6% that were treated with a single injection. No patient developed an inhibitor, and no safety concerns were identified. These results indicate rIX-FP is safe and effective for preventing and treating bleeding episodes in patients with hemophilia B at dosing regimens of 40 IU/kg weekly and 75 IU/kg every 2 weeks. This trial was registered atwww.clinicaltrials.govas #NCT0101496274. PMID:26755710

  12. Late Gastrointestinal Toxicity After Dose-Escalated Conformal Radiotherapy for Early Prostate Cancer: Results From the UK Medical Research Council RT01 Trial (ISRCTN47772397)

    International Nuclear Information System (INIS)

    Purpose: In men with localized prostate cancer, dose-escalated conformal radiotherapy (CFRT) improves efficacy outcomes at the cost of increased toxicity. We present a detailed analysis to provide further information about the incidence and prevalence of late gastrointestinal side effects. Methods and Materials: The UK Medical Research Council RT01 trial included 843 men with localized prostate cancer, who were treated for 6 months with neoadjuvant radiotherapy and were randomly assigned to either 64-Gy or 74-Gy CFRT. Toxicity was evaluated before CFRT and during long-term follow-up using Radiation Therapy Oncology Group (RTOG) grading, the Late Effects on Normal Tissue: Subjective, Objective, Management (LENT/SOM) scale, and Royal Marsden Hospital assessment scores. Patients regularly completed Functional Assessment of Cancer Therapy--Prostate (FACT-P) and University of California, Los Angeles, Prostate Cancer Index (UCLA-PCI) questionnaires. Results: In the dose-escalated group, the hazard ratio (HR) for rectal bleeding (LENT/SOM grade ≥2) was 1.55 (95% CI, 1.17-2.04); for diarrhea (LENT/SOM grade ≥2), the HR was 1.79 (95% CI, 1.10-2.94); and for proctitis (RTOG grade ≥2), the HR was 1.64 (95% CI, 1.20-2.25). Compared to baseline scores, the prevalence of moderate and severe toxicities generally increased up to 3 years and than lessened. At 5 years, the cumulative incidence of patient-reported severe bowel problems was 6% vs. 8% (standard vs. escalated, respectively) and severe distress was 4% vs. 5%, respectively. Conclusions: There is a statistically significant increased risk of various adverse gastrointestinal events with dose-escalated CFRT. This remains at clinically acceptable levels, and overall prevalence ultimately decreases with duration of follow-up.

  13. Results of a randomized and controlled clinical trial evaluating the efficacy and safety of combination therapy with Endostar and S-1 combined with oxaliplatin in advanced gastric cancer

    Directory of Open Access Journals (Sweden)

    Xu R

    2013-07-01

    Full Text Available Rong Xu*, Nan Ma*, Fang Wang, Lei Ma, Rui Chen, Ru Chen, Mijiti Kebinu, Lili Ma, Zhongcheng Han, Ayixiamu, Mahemiti Mayier, Pengcheng Su, Yiming Naman, Haliyazimu Jieensi, Haixuan Yang, Abulizi Adili, Saiding Aili, Jiang LiuDepartment of Medical Oncology, People’s Hospital of Xinjiang, Urumqi, People’s Republic of China*These authors contributed equally to this workObjectives: We aimed to evaluate the efficacy and safety of combination therapy of Endostar (recombinant human endostatin and S-1 combined with oxaliplatin (SOX in patients with advanced gastric cancer.Methods: In this randomized, controlled trial, 165 late-stage gastric cancer patients were assigned to the experimental arm with Endostar in combination with SOX (80 patients and the control arm with SOX alone (85 patients. The end points of this study included progression-free survival, response rate, and disease-control rate.Results: There was no statistically significant difference in response rate between the experimental arm and the control arm (53.8% vs 42.4%, P=0.188. The difference in disease-control rate was also statistically insignificant between the two arms (85.0% vs 72.9%, P=0.188. Progression-free survival in the experimental arm was significantly higher than that in the control arm (15.0 months vs 12.0 months, P=0.0001. Common adverse events included immunosuppression, gastrointestinal distress, and neuropathy. There was no statistical difference in the incidences of adverse events.Conclusion: Combination therapy of Endostar and SOX provides therapeutic benefits to advanced gastric cancer patients, with tolerable adverse effects.Keywords: endostatin, gastric cancer, SOX, oxaliplatin, Endostar, S-1

  14. Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial

    Science.gov (United States)

    Martinowitz, Uri; Lissitchkov, Toshko; Pan-Petesch, Brigitte; Hanabusa, Hideji; Oldenburg, Johannes; Boggio, Lisa; Negrier, Claude; Pabinger, Ingrid; von Depka Prondzinski, Mario; Altisent, Carmen; Castaman, Giancarlo; Yamamoto, Koji; Álvarez-Roman, Maria-Teresa; Voigt, Christine; Blackman, Nicole; Jacobs, Iris

    2016-01-01

    A global phase 3 study evaluated the pharmacokinetics, efficacy, and safety of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in 63 previously treated male patients (12-61 years) with severe hemophilia B (factor IX [FIX] activity ≤2%). The study included 2 groups: group 1 patients received routine prophylaxis once every 7 days for 26 weeks, followed by either 7-, 10-, or 14-day prophylaxis regimen for a mean of 50, 38, or 51 weeks, respectively; group 2 patients received on-demand treatment of bleeding episodes for 26 weeks and then switched to a 7-day prophylaxis regimen for a mean of 45 weeks. The mean terminal half-life of rIX-FP was 102 hours, 4.3-fold longer than previous FIX treatment. Patients maintained a mean trough of 20 and 12 IU/dL FIX activity on prophylaxis with rIX-FP 40 IU/kg weekly and 75 IU/kg every 2 weeks, respectively. There was 100% reduction in median annualized spontaneous bleeding rate (AsBR) and 100% resolution of target joints when subjects switched from on-demand to prophylaxis treatment with rIX-FP (P < .0001). The median AsBR was 0.00 for all prophylaxis regimens. Overall, 98.6% of bleeding episodes were treated successfully, including 93.6% that were treated with a single injection. No patient developed an inhibitor, and no safety concerns were identified. These results indicate rIX-FP is safe and effective for preventing and treating bleeding episodes in patients with hemophilia B at dosing regimens of 40 IU/kg weekly and 75 IU/kg every 2 weeks. This trial was registered at www.clinicaltrials.gov as #NCT0101496274. PMID:26755710

  15. 20 Gy Versus 44 Gy of Supplemental External Beam Radiotherapy With Palladium-103 for Patients With Greater Risk Disease: Results of a Prospective Randomized Trial

    Energy Technology Data Exchange (ETDEWEB)

    Merrick, Gregory S., E-mail: gmerrick@urologicresearchinstitute.org [Schiffler Cancer Center/Wheeling Jesuit University, Wheeling, WV (United States); Wallner, Kent E. [Puget Sound Healthcare Corporation, University of Washington, Seattle, WA (United States); Butler, Wayne M.; Galbreath, Robert W. [Schiffler Cancer Center/Wheeling Jesuit University, Wheeling, WV (United States); Taira, Al V. [Western Radiation Oncology Inc, Mountain View, CA (United States); Orio, Peter [Department of Radiation Oncology, Dana Farber Cancer Institute/Brigham and Women' s Hospital, Harvard Medical School, Boston, MA (United States); Adamovich, Edward [Department of Pathology, Wheeling Hospital, Wheeling, WV (United States)

    2012-03-01

    Purpose: The necessity of external beam radiotherapy (EBRT) as a supplement to prostate brachytherapy remains unknown. We report brachytherapy outcomes for patients with higher risk features randomized to substantially different supplemental EBRT regimens. Methods and Materials: Between December 1999 and June 2004, 247 patients were randomized to 20 Gy vs. 44 Gy EBRT followed by a palladium-103 boost (115 Gy vs. 90 Gy). The eligibility criteria included clinically organ-confined disease with Gleason score 7-10 and/or pretreatment prostate-specific antigen (PSA) level 10-20 ng/mL. The median follow-up period was 9.0 years. Biochemical progression-free survival (bPFS) was defined as a PSA level of {<=}0.40 ng/mL after nadir. The median day 0 prescribed dose covering 90% of the target volume was 125.7%; 80 men received androgen deprivation therapy (median, 4 months). Multiple parameters were evaluated for their effect on bPFS. Results: For the entire cohort, the cause-specific survival, bPFS, and overall survival rates were 97.7%, 93.2%, and 80.8% at 8 years and 96.9%, 93.2%, and 75.4% at 10 years, respectively. The bPFS rate was 93.1% and 93.4% for the 20-Gy and 44-Gy arms, respectively (p = .994). However, no statistically significant differences were found in cause-specific survival or overall survival were identified. When stratified by PSA level of {<=}10 ng/mL vs. >10 ng/mL, Gleason score, or androgen deprivation therapy, no statistically significant differences in bPFS were discerned between the two EBRT regimens. On multivariate analysis, bPFS was most closely related to the preimplant PSA and clinical stage. For patients with biochemically controlled disease, the median PSA level was <0.02 ng/mL. Conclusion: The results of the present trial strongly suggest that two markedly different supplemental EBRT regimens result in equivalent cause-specific survival, bPFS, and overall survival. It is probable that the lack of benefit for a higher supplemental EBRT dose

  16. 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

  17. Preschool Teachers Can Use a PBS KIDS Transmedia Curriculum Supplement to Support Young Children's Mathematics Learning: Results of a Randomized Controlled Trial

    Science.gov (United States)

    Llorente, Carlin; Pasnik, Shelley; Moorthy, Savitha; Hupert, Naomi; Rosenfeld, Deborah; Gerard, Sarah

    2015-01-01

    The current study, a randomized controlled trial, explores how technology and educational transmedia resources can enhance prekindergarten math teaching and learning in preschools, especially those serving children who may be at risk for academic difficulties due to economic and social disadvantages. This research is part of a multi-year summative…

  18. Improved outcomes in elderly patients with metastatic castration-resistant prostate cancer treated with the androgen receptor inhibitor enzalutamide: results from the phase III AFFIRM trial

    NARCIS (Netherlands)

    Sternberg, C.N.; Bono, J.S. de; Chi, K.N.; Fizazi, K.; Mulders, P.; Cerbone, L.; Hirmand, M.; Forer, D.; Scher, H.I.

    2014-01-01

    BACKGROUND: The randomized, double-blind phase III AFFIRM trial demonstrated that enzalutamide, an oral androgen receptor inhibitor, significantly prolonged overall survival (OS) [median 18.4 versus 13.6 months (hazard ratio, HR) 0.63 (95% confidence interval, CI, 0.53-0.75); P<0.001] compared wi

  19. Making consent more informed: preliminary results from a multiple-choice test among probation-referred marijuana users entering a randomized clinical trial.

    Science.gov (United States)

    Rounsaville, Daniel B; Hunkele, Karen; Easton, Caroline J; Nich, Charla; Carroll, Kathleen M

    2008-01-01

    Although individuals who use illicit drugs are a potentially vulnerable population, there have been no objective evaluations of the effectiveness of standard informed consent procedures in assuring that prospective participants entering drug abuse treatment trials fully understand the nature of the research and treatments in which they have agreed to participate. Young, marijuana-dependent adults referred by the criminal justice system who were enrolling in a randomized treatment trial were asked to complete a multiple-choice quiz concerning basic elements of the trial before providing written informed consent. Participants were assigned to standard drug counseling or motivational interviewing/skills-building therapy, delivered alone or with incentives for attending sessions and submitting marijuana-free urine specimens. Only 55 percent of the 130 participants correctly answered all four questions, and 20 percent incorrectly answered a question concerning their right to refuse to participate. An unexpected finding was that quiz scores were modestly associated with marijuana use outcome measures. These preliminary findings highlight the importance of systematically evaluating the understanding of research participants, particularly those in vulnerable populations, of their rights and key aspects of the trials in which they agree to participate. PMID:18802184

  20. Comparison of early and late results of a Carbofilm-coated stent versus a pure high-grade stainless steel stent (the Carbostent-Trial).

    NARCIS (Netherlands)

    Sick, P.B.; Gelbrich, G.; Kalnins, U.; Erglis, A.; Bonan, R.; Aengevaeren, W.R.M.; Elsner, D.; Lauer, B.; Woinke, M.; Brosteanu, O.; Schuler, G.

    2004-01-01

    The long-term success of coronary interventions with stents is largely determined by the development of restenosis. The aim of this study was to compare a Carbofilm-coated and a pure stainless steel stent with regard to early and late adverse events. In this prospective, randomized trial, the Carbof

  1. Long-term results of Danish Prostatic Cancer Group trial 86. Goserelin acetate plus flutamide versus orchiectomy in advanced prostate cancer

    DEFF Research Database (Denmark)

    Iversen, P; Rasmussen, F; Klarskov, Peter;

    1993-01-01

    In a multicenter trial conducted by the Danish Prostatic Cancer Group, 264 patients with advanced prostate cancer were randomized either to undergo bilateral orchiectomy or to receive combination treatment with goserelin acetate and flutamide. This report is an update of that study, covering...... of goserelin and flutamide was not clinically superior to bilateral orchiectomy in the treatment of advanced prostate cancer....

  2. Acute toxicity profile and compliance to accelerated radiotherapy plus carbogen and nicotinamide for clinical stage T2-4 laryngeal cancer: results of a phase III randomized trial.

    NARCIS (Netherlands)

    Janssens, G.O.R.J.; Terhaard, C.H.J.; Doornaert, P.A.; Bijl, H.P.; Ende, P. van den; Chin, A.; Pop, L.A.M.; Kaanders, J.H.A.M.

    2012-01-01

    PURPOSE: To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer. METHODS AND MATERIALS: From April 2001 to February 2008, 345 patients with

  3. ACUTE TOXICITY PROFILE AND COMPLIANCE TO ACCELERATED RADIOTHERAPY PLUS CARBOGEN AND NICOTINAMIDE FOR CLINICAL STAGE T2-4 LARYNGEAL CANCER : RESULTS OF A PHASE III RANDOMIZED TRIAL

    NARCIS (Netherlands)

    Janssens, Geert O.; Terhaard, Chris H.; Doornaert, Patricia A.; Bijl, Hendrik P.; van den Ende, Piet; Chin, Alim; Pop, Lucas A.; Kaanders, Johannes H.

    2012-01-01

    Purpose: To report the acute toxicity profile and compliance from a randomized Phase III trial comparing accelerated radiotherapy (AR) with accelerated radiotherapy plus carbogen and nicotinamide (ARCON) in laryngeal cancer. Methods and Materials: From April 2001 to February 2008, 345 patients with

  4. Laparoscopic Sphincter Augmentation Device Eliminates Reflux Symptoms and Normalizes Esophageal Acid Exposure One- and 2-Year Results of a Feasibility Trial

    NARCIS (Netherlands)

    L. Bonavina; T. Demeester; P. Fockens; D. Dunn; G. Saino; D. Bona; J. Lipham; W. Bemelman; R.A. Ganz

    2010-01-01

    Objectives: One- and 2-year evaluation of a feasibility trial (clinicaltrials.gov registration numbers NCT01057992, NCT01058070, and 01058564) to assess the safety and efficacy of a laparoscopically implanted sphincter augmentation device for the treatment of gastroesophageal reflux disease (GERD).

  5. The Effects of Therapist Competence in Assigning Homework in Cognitive Therapy with Cluster C Personality Disorders: Results from a Randomized Controlled Trial

    Science.gov (United States)

    Ryum, Truls; Stiles, Tore C.; Svartberg, Martin; McCullough, Leigh

    2010-01-01

    Therapist competence in assigning homework was used to predict mid- and posttreatment outcome for patients with Cluster C personality disorders in cognitive therapy (CT). Twenty-five patients that underwent 40 sessions of CT were taken from a randomized controlled trial (Svartberg, Stiles, & Seltzer, 2004). Therapist competence in assigning…

  6. The Potent Bile Acid Sequestrant Colesevelam Is Not Effective in Cholestatic Pruritus: Results of a Double-Blind, Randomized, Placebo-Controlled Trial

    NARCIS (Netherlands)

    E.M.M. Kuiper; K.J. van Erpecum; U. Beuers; B.E. Hansen; H.B. Thio; R.A. de Man; H.L.A. Janssen; H.R. van Buuren

    2010-01-01

    Colesevelam is an anion-exchange resin with a 7-fold higher bile acid binding capacity and fewer side effects than cholestyramine, the current first-line treatment option for cholestatic pruritus. The aim of this trial was to compare the effects of colesevelam and a placebo in patients with cholesta

  7. Mandibular Overdentures Retained by Two Implants : 10-Year Results from a Crossover Clinical Trial Comparing Ball-Socket and Bar-Clip Attachments

    NARCIS (Netherlands)

    Cune, Marco; Burgers, Mark; van Kampen, Frits; de Putter, Cornelis; van der Bilt, Andries

    2010-01-01

    Purpose: The aim of this study was to evaluate patient satisfaction and clinical and prosthetic outcomes of two-implant mandibular overdenture treatment with different attachment types after 10 years of function. Materials and Methods: In a crossover clinical trial, 18 edentulous subjects with compl

  8. Slowing of bone loss in patients with rheumatoid arthritis by long-term high-intensity exercise: results of a randomized, controlled trial.

    NARCIS (Netherlands)

    Jong, Z. de; Munneke, M.; Lems, W.F.; Zwinderman, A.H.; Kroon, H.M.; Pauwels, E.K.; Jansen, A.; Ronday, K.H.; Dijkmans, B.A.C.; Breedveld, F.C.; Vliet Vlieland, T.P.M.; Hazes, J.M.W.

    2004-01-01

    OBJECTIVE: Patients with rheumatoid arthritis (RA) are more at risk for the development of osteoporosis and osteoporotic fractures than are their healthy peers. In this randomized, controlled, multicenter trial, the effectiveness of a 2-year high-intensity weight-bearing exercise program (the Rheuma

  9. The Efficacy of Web-Based and Print-Delivered Computer-Tailored Interventions to Reduce Fat Intake: Results of a Randomized, Controlled Trial

    Science.gov (United States)

    Kroeze, Willemieke; Oenema, Anke; Campbell, Marci; Brug, Johannes

    2008-01-01

    Objective: To test and compare the efficacy of interactive- and print-delivered computer-tailored nutrition education targeting saturated fat intake reduction. Design: A 3-group randomized, controlled trial (2003-2005) with posttests at 1 and 6 months post-intervention. Setting: Worksites and 2 neighborhoods in the urban area of Rotterdam.…

  10. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: Two year results of a randomised controlled trial

    NARCIS (Netherlands)

    W.C. Peul (Wilco); W.B. van den Hout (Wilbert); R. Brand (René); R.T.W.M. Thomeer (Raph); B.W. Koes (Bart)

    2008-01-01

    textabstractObjectives: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. Design: Randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with 6-12 weeks of sciatica. I

  11. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation : two year results of a randomised controlled trial

    NARCIS (Netherlands)

    Peul, W.C.; Hout, van den W.B.; Brand, R.; Thomeer, R.T.W.M.; Koes, B.W.

    2008-01-01

    Objectives: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. Design: Randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with 6-12 weeks of sciatica. Interventions

  12. Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent : 4-year results of the PROTECT randomized trial

    NARCIS (Netherlands)

    Wijns, William; Steg, Ph. Gabriel; Mauri, Laura; Kurowski, Volkhard; Parikh, Keyur; Gao, Runlin; Bode, Christoph; Greenwood, John P.; Lipsic, Erik; Alamgir, Farqad; Rademaker-Havinga, Tessa; Boersma, Eric; Radke, Peter; van Leeuwen, Frank; Camenzind, Edoardo

    2014-01-01

    Aims To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour (E-ZES) vs. Cypher (C-SES) Stenting Trial (PROTECT). At 3 years, there was no difference in the primary outcome of definite or probable

  13. Peer review comments on drug trials submitted to medical journals differ depending on sponsorship, results and acceptance: a retrospective cohort study

    NARCIS (Netherlands)

    Lent, M. van; Hout, J. in't; Out, H.J.

    2015-01-01

    OBJECTIVE: During peer review, submitted manuscripts are scrutinised by independent experts to assist journal editors in their decision-making and to help improve the quality of articles. In this retrospective cohort study, peer review comments for drug trials submitted to medical journals were anal

  14. Is a long-term high-intensity exercise program effective and safe in patients with rheumatoid arthritis? Results of a randomized controlled trial.

    NARCIS (Netherlands)

    Jong, Z. de; Munneke, M.; Zwinderman, A.H.; Kroon, H.M.; Jansen, A.; Ronday, H.K.; Schaardenburg, D. van; Dijkmans, B.A.C.; Ende, C.H.M. van den; Breedveld, F.C.; Vliet Vlieland, T.P.M.; Hazes, J.M.W.

    2003-01-01

    OBJECTIVE: There are insufficient data on the effects of long-term intensive exercise in patients with rheumatoid arthritis (RA). We undertook this randomized, controlled, multicenter trial to compare the effectiveness and safety of a 2-year intensive exercise program (Rheumatoid Arthritis Patients

  15. Clinical and radiological results of patients treated with three treatment modalities for overdentures on implants of the ITI (R) Dental Implant System - A randomized controlled clinical trial

    NARCIS (Netherlands)

    Wismeijer, D; van Waas, MAJ; Mulder, J; Vermeeren, JIJF; Kalk, W

    1999-01-01

    In a randomized controlled clinical trial carried out at the Ignatius teaching hospital in Breda, The Netherlands, 110 edentulous patients with severe mandibular bone loss were treated with implants of the ITI(R) Dental Implant System using 3 different treatment strategies: a mandibular overdenture

  16. A Parent-Mediated Intervention that Targets Responsive Parental Behaviors Increases Attachment Behaviors in Children with ASD: Results from a Randomized Clinical Trial

    Science.gov (United States)

    Siller, Michael; Swanson, Meghan; Gerber, Alan; Hutman, Ted; Sigman, Marian

    2014-01-01

    The current study is a randomized clinical trial evaluating the efficacy of Focused Playtime Intervention (FPI) in a sample of 70 children with Autism Spectrum Disorder. This parent-mediated intervention has previously been shown to significantly increase responsive parental communication (Siller et al. in "J Autism Dev Disord"…

  17. Sensitivity of the Modified Children's Yale-Brown Obsessive Compulsive Scale to Detect Change: Results from Two Multi-Site Trials

    Science.gov (United States)

    Scahill, Lawrence; Sukhodolsky, Denis G.; Anderberg, Emily; Dimitropoulos, Anastasia; Dziura, James; Aman, Michael G.; McCracken, James; Tierney, Elaine; Hallett, Victoria; Katz, Karol; Vitiello, Benedetto; McDougle, Christopher

    2016-01-01

    Repetitive behavior is a core feature of autism spectrum disorder. We used 8-week data from two federally funded, multi-site, randomized trials with risperidone conducted by the Research Units on Pediatric Psychopharmacology Autism Network to evaluate the sensitivity of the Children's Yale-Brown Obsessive Compulsive Scale modified for autism…

  18. A lifestyle intervention to reduce Type 2 diabetes risk in Dutch primary care: 2.5-year results of a randomized controlled trial.

    NARCIS (Netherlands)

    Vermunt, P.W.; Milder, I.E.; Wielaard, F.; Vries, J.H. de; Baan, C.A.; Oers, J.A. van; Westert, G.P.

    2012-01-01

    Diabet. Med. 29, e223-e231 (2012) ABSTRACT: Aims To determine the effectiveness of a 2.5-year lifestyle intervention for Type 2 diabetes prevention in Dutch general practice compared with usual care. Methods A randomized controlled trial of 925 individuals at high risk for Type 2 diabetes (FINDRISC-

  19. Accelerated partial breast irradiation with iridium-192 multicatheter PDR/HDR brachytherapy. Preliminary results of the German-Austrian multicenter trial

    International Nuclear Information System (INIS)

    Purpose: to evaluate perioperative morbidity, toxicity, and cosmetic outcome in patients treated with interstitial brachytherapy to the tumor bed as the sole irradiation modality after breast-conserving surgery. Patients and methods: from November 1, 2000 to January 31, 2004, 176 women with early-stage breast cancer became partakers in a protocol of tumor bed irradiation alone using pulsed-dose-rate (PDR) or high-dose-rate (HDR) interstitial multicatheter implants. Patients became eligible, if their tumor was an infiltrating carcinoma ≤ 3 cm in diameter, the surgical margins were clear by at least 2 mm, the axilla was surgically staged node-negative, the tumor was estrogen and/or progesterone receptor-positive, well or moderately differentiated (G1/2), the tumor did not contain an extensive intraductal component (EIC) and the patient's age was > 35 years. Implants were positioned using a template guide, delivering either 49.8 Gy in 83 consecutive hours (PDR) or 32.0 Gy in two daily fractions over 4 days (HDR). Perioperative morbidity, toxicity, and cosmetic outcome were assessed. Interim findings of the first 69 patients, who were treated in this multicenter trial, after a median follow-up of 24 months (range, 15-39 months) are presented. Results: one of the 69 patients (1.4%) developed a bacterial infection of the implant. No other perioperative complications, for example bleeding or hematoma, were observed. Acute toxicity was low: 2.9% of the patients (2/69) experienced mild radiodermatitis. Late toxicity: hypersensation/mild pain 7.2% (5/69), intermittent but tolerable pain 1.4% (1/69), mild dyspigmentation 10.1% (7/69), mild fibrosis 11.6% (8/69), moderate fibrosis 1.4% (1/69), mild telangiectasia (2) 11.6% (8/69), and moderate teleangiectasia (1-4 cm2) 1.4% (1/69). Good to excellent cosmetic results were observed in 92.4% of the patients evaluated. All patients (n = 176) remained disease-free to the date of evaluation. Conclusion: this analysis indicates

  20. Accelerated partial breast irradiation with iridium-192 multicatheter PDR/HDR brachytherapy. Preliminary results of the German-Austrian multicenter trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, O.J.; Lotter, M.; Sauer, R.; Strnad, V. [Dept. of Radiation Oncology, Univ. Hospital Erlangen, Erlangen (Germany); Poetter, R.; Resch, A. [Dept. of Radiotherapy and Radiobiology, Univ. Hospital AKH Wien, Vienna (Austria); Hammer, J. [Dept. of Radiation Oncology, Barmherzige Schwestern Hospital Linz, Linz (Austria); Hildebrandt, G. [Dept. of Radiation Oncology, Univ. Hospital Leipzig, Leipzig (Germany); Poehls, U.; Beckmann, M.W. [Dept. of Gynecology, Univ. Hospital Erlangen, Erlangen (Germany)

    2004-10-01

    Purpose: to evaluate perioperative morbidity, toxicity, and cosmetic outcome in patients treated with interstitial brachytherapy to the tumor bed as the sole irradiation modality after breast-conserving surgery. Patients and methods: from November 1, 2000 to January 31, 2004, 176 women with early-stage breast cancer became partakers in a protocol of tumor bed irradiation alone using pulsed-dose-rate (PDR) or high-dose-rate (HDR) interstitial multicatheter implants. Patients became eligible, if their tumor was an infiltrating carcinoma {<=} 3 cm in diameter, the surgical margins were clear by at least 2 mm, the axilla was surgically staged node-negative, the tumor was estrogen and/or progesterone receptor-positive, well or moderately differentiated (G1/2), the tumor did not contain an extensive intraductal component (EIC) and the patient's age was > 35 years. Implants were positioned using a template guide, delivering either 49.8 Gy in 83 consecutive hours (PDR) or 32.0 Gy in two daily fractions over 4 days (HDR). Perioperative morbidity, toxicity, and cosmetic outcome were assessed. Interim findings of the first 69 patients, who were treated in this multicenter trial, after a median follow-up of 24 months (range, 15-39 months) are presented. Results: one of the 69 patients (1.4%) developed a bacterial infection of the implant. No other perioperative complications, for example bleeding or hematoma, were observed. Acute toxicity was low: 2.9% of the patients (2/69) experienced mild radiodermatitis. Late toxicity: hypersensation/mild pain 7.2% (5/69), intermittent but tolerable pain 1.4% (1/69), mild dyspigmentation 10.1% (7/69), mild fibrosis 11.6% (8/69), moderate fibrosis 1.4% (1/69), mild telangiectasia (< 1 cm{sup 2}) 11.6% (8/69), and moderate teleangiectasia (1-4 cm{sup 2}) 1.4% (1/69). Good to excellent cosmetic results were observed in 92.4% of the patients evaluated. All patients (n = 176) remained disease-free to the date of evaluation. Conclusion

  1. Long-term Results of the UCSF-LBNL Randomized Trial: Charged Particle With Helium Ion Versus Iodine-125 Plaque Therapy for Choroidal and Ciliary Body Melanoma

    Energy Technology Data Exchange (ETDEWEB)

    Mishra, Kavita K., E-mail: Kavita.mishra@ucsf.edu [Department of Radiation Oncology, University of California-San Francisco, San Francisco, California (United States); Quivey, Jeanne M.; Daftari, Inder K. [Department of Radiation Oncology, University of California-San Francisco, San Francisco, California (United States); Lawrence Berkeley National Laboratory, Berkeley, California (United States); Weinberg, Vivian [Department of Radiation Oncology, University of California-San Francisco, San Francisco, California (United States); Cole, Tia B. [The Tumori Foundation, San Francisco, California (United States); Patel, Kishan [Department of Radiation Oncology, University of California-San Francisco, San Francisco, California (United States); Castro, Joseph R.; Phillips, Theodore L. [Department of Radiation Oncology, University of California-San Francisco, San Francisco, California (United States); Lawrence Berkeley National Laboratory, Berkeley, California (United States); Char, Devron H. [The Tumori Foundation, San Francisco, California (United States); Department of Ophthalmology, University of California-San Francisco, San Francisco, California (United States); Department of Ophthalmology, Stanford University, Palo Alto, California (United States)

    2015-06-01

    Purpose: Relevant clinical data are needed given the increasing national interest in charged particle radiation therapy (CPT) programs. Here we report long-term outcomes from the only randomized, stratified trial comparing CPT with iodine-125 plaque therapy for choroidal and ciliary body melanoma. Methods and Materials: From 1985 to 1991, 184 patients met eligibility criteria and were randomized to receive particle (86 patients) or plaque therapy (98 patients). Patients were stratified by tumor diameter, thickness, distance to disc/fovea, anterior extension, and visual acuity. Tumors close to the optic disc were included. Local tumor control, as well as eye preservation, metastases due to melanoma, and survival were evaluated. Results: Median follow-up times for particle and plaque arm patients were 14.6 years and 12.3 years, respectively (P=.22), and for those alive at last follow-up, 18.5 and 16.5 years, respectively (P=.81). Local control (LC) for particle versus plaque treatment was 100% versus 84% at 5 years, and 98% versus 79% at 12 years, respectively (log rank: P=.0006). If patients with tumors close to the disc (<2 mm) were excluded, CPT still resulted in significantly improved LC: 100% versus 90% at 5 years and 98% versus 86% at 12 years, respectively (log rank: P=.048). Enucleation rate was lower after CPT: 11% versus 22% at 5 years and 17% versus 37% at 12 years, respectively (log rank: P=.01). Using Cox regression model, likelihood ratio test, treatment was the most important predictor of LC (P=.0002) and eye preservation (P=.01). CPT was a significant predictor of prolonged disease-free survival (log rank: P=.001). Conclusions: Particle therapy resulted in significantly improved local control, eye preservation, and disease-free survival as confirmed by long-term outcomes from the only randomized study available to date comparing radiation modalities in choroidal and ciliary body melanoma.

  2. Predictors and impact of non-adherence in adults with attention-deficit/hyperactivity disorder receiving OROS methylphenidate: results from a randomized, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Kooij J J Sandra

    2013-01-01

    Full Text Available Abstract Background Medication non-adherence has an important impact on treatment efficacy and healthcare burden across a range of conditions and therapeutic areas. The aim of this analysis was to determine predictors of non-adherence and impact of non-adherence on treatment response in adults with attention-deficit/hyperactivity disorder (ADHD. Methods Post-hoc analysis of a 13-week randomized, double-blind placebo-controlled study of OROS methylphenidate (MPH 54 and 72 mg/day. Primary efficacy variable was the Conners’ Adult ADHD Rating Scale – Screening Version (CAARS:O-SV. Daily adherence was calculated as average daily adherence (100 × capsules taken/2, with overall adherence calculated as the average daily adherence. Predictors of adherence were assessed using mixed-effects logistic regression. Descriptive statistics were generated for change in CAARS:O-SV score for adherent (> 95% adherence and non-adherent subjects. Predictors of change were analyzed using a mixed model. Results Subjects were allocated to OROS MPH (54 mg, n = 87; 72 mg, n = 92 or placebo (n = 97. Mean adherence was 92.6% and 93.3% (OROS MPH 54 and 72 mg/day, respectively, versus 97.5% (placebo. Adherence was higher and less variable in completers. Factors significantly associated with non-adherence included female sex, shorter time since ADHD diagnosis, higher education level (completion of university and score on the Drug Use Screening Inventory psychiatric disorders subscale. Improvements from baseline in CAARS:O-SV score were numerically greater in subjects defined as adherent than in those who were non-adherent. Significant predictors of CAARS:O-SV change in patients who completed the study included percentage adherence up to the point of assessment (p p p = 0.0003. Conclusion The results of this analysis suggest that newly diagnosed patients, those with a high score on the DUSI-R psychiatric disorder scale, women, and subjects with high educational degrees may

  3. Long-term treatment with metformin in obese, insulin-resistant adolescents: results of a randomized double-blinded placebo-controlled trial

    Science.gov (United States)

    van der Aa, M P; Elst, M A J; van de Garde, E M W; van Mil, E G A H; Knibbe, C A J; van der Vorst, M M J

    2016-01-01

    Background: As adolescents with obesity and insulin resistance may be refractory to lifestyle intervention therapy alone, additional off-label metformin therapy is often used. In this study, the long-term efficacy and safety of metformin versus placebo in adolescents with obesity and insulin resistance is studied. Methods: In a randomized placebo-controlled double-blinded trial, 62 adolescents with obesity aged 10–16 years old with insulin resistance received 2000 mg of metformin or placebo daily and physical training twice weekly over 18 months. Primary end points were change in body mass index (BMI) and insulin resistance measured by the Homeostasis Model Assessment for Insulin Resistance (HOMA-IR). Secondary end points were safety and tolerability of metformin. Other end points were body fat percentage and HbA1c. Results: Forty-two participants completed the 18-month study (66% girls, median age 13 (12–15) years, BMI 30.0 (28.3 to 35.0) kg m−2 and HOMA-IR 4.08 (2.40 to 5.88)). Median ΔBMI was +0.2 (−2.9 to 1.3) kg m−2 (metformin) versus +1.2 (−0.3 to 2.4) kg m−2 (placebo) (P=0.015). No significant difference was observed for HOMA-IR. No serious adverse events were reported. Median change in fat percentage was −3.1 (−4.8 to 0.3) versus −0.8 (−3.2 to 1.6)% (P=0.150), in fat mass −0.2 (−5.2 to 2.1) versus +2.0 (1.2–6.4) kg (P=0.007), in fat-free mass +2.0 (−0.1 to 4.0) versus +4.5 (1.3 to 11.6) kg (P=0.047) and in ΔHbA1c +1.0 (−1.0 to 2.3) versus +3.0 (0.0 to 5.0) mmol mol−1 (P=0.020) (metformin versus placebo). Conclusions: Long-term treatment with metformin in adolescents with obesity and insulin resistance results in stabilization of BMI and improved body composition compared with placebo. Therefore, metformin may be useful as an additional therapy in combination with lifestyle intervention in adolescents with obesity and insulin resistance. PMID:27571249

  4. Participating in Clinical Trials

    Medline Plus

    Full Text Available ... on their phase. The U.S. Food and Drug Administration typically requires Phase 1, 2 and 3 trials ... 000 people. If the U.S. Food and Drug Administration agrees that the trial results are positive, they ...

  5. The effects of a 25% discount on fruits and vegetables: results of a randomized trial in a three-dimensional web-based supermarket

    Directory of Open Access Journals (Sweden)

    Waterlander Wilma E

    2012-02-01

    Full Text Available Abstract Background Lowering the price of fruit and vegetables is a promising strategy in stimulating the purchase of those foods. However, the true effects of this strategy are not well studied and it is unclear how the money saved is spent. The aim of this study is to examine the effects of a 25% discount on fruits and vegetables on food purchases in a supermarket environment. Methods A randomized controlled trial with two research conditions was conducted: a control condition with regular prices (n = 52 and an experimental condition with a 25% discount on fruits and vegetables (n = 63. The experiment was carried out using a three-dimensional web-based supermarket, which is a software application in the image of a real supermarket. Data were collected in 2010 in the Netherlands. Participants received a fixed budget and were asked to buy weekly household groceries at the web-based supermarket. Differences in fruit and vegetable purchases, differences in expenditures in other food categories and differences in total calories were analyzed using independent samples t-tests and multiple linear regression models accounting for potential effect modifiers and confounders. Results The purchased amount of fruit plus vegetables was significantly higher in the experimental condition compared to the control condition (Δ984 g per household per week, p = .03 after appropriate adjustments. This corresponds to a 25% difference compared to the control group. Both groups had similar expenditures in unhealthier food categories, including desserts, soda, crisps, candy and chocolate. Furthermore, both groups purchased an equal number of food items and an equal amount of calories, indicating that participants in the discount condition did not spend the money they saved from the discounts on other foods than fruits and vegetables. Conclusion A 25% discount on fruits and vegetables was effective in stimulating purchases of those products and did neither lead to

  6. Oral fibrinogen-depleting agent lumbrokinase for secondary ischemic stroke prevention: results from a multicenter, randomized, parallel-group and controlled clinical trial

    Institute of Scientific and Technical Information of China (English)

    CAO Yong-jun; ZHANG Xia; WANG Wan-hua; ZHAI Wan-qing; QIAN Ju-fen; WANG Jian-sheng; CHEN Jun

    2013-01-01

    Background Elevated fibrinogen (Fg) level is a known risk factor for ischemic stroke.There are few clinical trials on oral fibrinogen-depleting therapies for secondary ischemic stroke prevention.We aimed to assess the effects of one-year therapy with oral lumbrokinase enteric-coated capsules on secondary ischemic stroke prevention.Methods This is a multicenter,randomized,parallel group and controlled study that began treatment in hospitalized patients with ischemic stroke and continued for 12 months.Patients were randomized to either the control group that received the standard stroke treatment or the fibrinogen-depleting group that received the standard stroke treatment plus enteric-coated lumbrokinase capsules.The NIH Stroke Scale scores (NIHSSs) and plasma Fg level were recorded.The carotid artery intima-media thickness (IMT) and status of plaques were examined through carotid ultrasound examination.Primary outcomes included all-cause mortality,any event of recurrent ischemic stroke/transient ischemic attack (TIA),hemorrhagic stroke,myocardial infarction and angina,and other noncerebral ischemia or hemorrhage.Kaplan-Meier survival analysis and the Long-rank test were used to compare total vascular end point incidence between the two groups.Comparison of median values between two groups was done by the Student t test,one-way analysis of variance (ANOVA),or non-parametric rank sum test.Results A total of 310 patients were enrolled,192 patients in the treatment group and 118 patients in the control group.Compared to the control group,the treatment group showed favorable outcomes in the Fg level,carotid IMT,the detection rate of vulnerable plaques,the volume of carotid plaques,NIHSS scores,and incidence of total vascular (6.78% and 2.08%,respectively) and cerebral vascular events (5.93% and 1.04%,respectively) (P <0.05).In the treatment group,the volume of carotid plaques was significantly related to the carotid IMT,the plaque diameter,width and number (P

  7. Clinical experience with the MammoSite[reg] radiation therapy system for brachytherapy of breast cancer: Results from an international phase II trial

    International Nuclear Information System (INIS)

    Background and purpose: In a prospective multi-center phase II trial, we investigated the MammoSite[reg] Radiation Therapy System, a new device for delivering intracavitary brachytherapy following breast conserving surgery. The MammoSite[reg] is a dual lumen, closed ended catheter with a small, spherical inflatable balloon and a port for connecting a remote afterloader to the central lumen. We analyzed the surgical procedure and placement of the MammoSite[reg], treatment planning and radiation delivery complications and cosmesis, as well the comfort for the patients. Patients and methods: Between 2002 and 2004 a total of 32 patients (pts) were implanted using the MammoSite[reg]. The reference isodose was defined 1 cm from the balloon surface. We analyzed the post-implant anatomic position of the applicator and the geometric form of the balloon via ultrasound, CT and X-ray, related side effects, cosmetic outcome and patient quality of life. Results: Twenty-three out of 32 patients (72%) were eligible for MammoSite[reg] intracavitary brachytherapy. Twenty-eight percentage had to be excluded because of different reasons. Eleven patients were treated with primary brachytherapy with a total dose of 34 Gy (2x3.4 Gy) and 12 had a boost with a mean dose of 13.3 Gy (range: 7.5-15 Gy; 2x2.5 Gy) combined with EBRT and doses ranged between 46 and 50 Gy. In three cases a balloon rupture occurred. We observed two abscesses within 3 months of implantation and serious seroma development in 10 patients (39%). Skin related side effects were erythema in 21 patients (91%), hyperpigmentation in 13 patients (56%) and teleangiectasia in six patients (26%) after mean follow-up 20 months. Conclusions: The MammoSite[reg] Radiation Therapy System is a feasible treatment modality for intracavitary brachytherapy of breast cancer after breast conserving surgery. The advantage of the system is only one applicator is necessary for the delivery of a fractionated radiotherapy. In addition, patient

  8. Patient-reported benefit of ReSTOR® multi-focal intraocular lenses after cataract surgery: Results of Principal Component Analysis on clinical trial data

    Directory of Open Access Journals (Sweden)

    Viala Muriel

    2008-01-01

    Full Text Available Abstract Background Restoration of functional distance and near vision independently of additional correction remains a goal for cataract surgery. ReSTOR®, a new multi-focal intraocular lens (IOL addresses this issue with an improvement in both distance and near vision, often without need for glasses. This analysis attempted to discuss the patient-reported benefit of ReSTOR® using a full but organised representation of data. Methods Two non-randomised, open-label clinical trials conducted in Europe and the United-States were conducted to compare the efficacy of ReSTOR® to AcrySof® mono-focal IOLs. A total of 710 patients in need of bilateral cataract extraction were included in the pooled study. The TyPE, a patient questionnaire, was fully completed by 672 of them before and after each eye surgery. The TyPE, composed of 67 items measuring overall visual functioning in both conditions (with and without wearing glasses, evaluates limitations, troubles and satisfaction in distance and near vision. A principal component analysis (PCA of the TyPE questionnaire was performed on pooled data from baseline and post-surgery observations in order to fully represent the change in the TyPE data over time. ReSTOR® and mono-focal groups were used as illustrative variables. The coordinates of the first 2 factors were compared between visits and between IOLs (ReSTOR® vs. mono-focal, using paired t-tests and t-tests, respectively. Results The first factor of the PCA explained 55% of the variance and represented 'visual functioning and patient satisfaction'. The second factor explained 6% of the variance and was interpreted as 'independence from glasses'. An overall difference in factorial coordinates in both factors was seen between baseline and the first eye surgery, and between the first and the second eye surgery. No difference between ReSTOR® and mono-focal IOL groups was observed at baseline. After surgery, ReSTOR® treated-patients had higher

  9. Effects of psychosocial stimulation on improving home environment and child-rearing practices: results from a community-based trial among severely malnourished children in Bangladesh

    Directory of Open Access Journals (Sweden)

    Nahar Baitun

    2012-08-01

    Full Text Available Abstract Background Parenting programmes are effective in enhancing parenting practices and child development. This study evaluated the effects of a intervention with psychosocial stimulation (PS on the quality of the home environment and mothers’ child-rearing practices in a community-based trial with severely malnourished Bangladeshi children. Method Severely underweight children (n = 507, 6–24 months of age, were randomly assigned to five groups: PS; food supplementation (FS; PS + FS; clinic-control (CC; and, hospital-control (CH. PS included fortnightly follow-up visits for six months at community clinics where a play leader demonstrated play activities and gave education on child development and child rearing practices. FS comprised cereal-base