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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. Field trials results of guided wave tomography

    Science.gov (United States)

    Volker, Arno; van Zon, Tim; van der Leden, Edwin

    2015-03-01

    Corrosion is one of the industries major issues regarding the integrity of assets. Guided wave travel time tomography is a method capable of providing an absolute wall thickness map. This method is currently making the transition from the laboratory to the field. For this purpose a dedicated data acquisition system and special purpose EMAT sensor rings have been developed. The system can be deployed for permanent monitoring and inspections. Field trials have been conducted on various pipes with different diameters, containing either liquid or gas. The main focus has been on pipe supports. The results demonstrate the successful operation of the technology in the field. Expected corrosion damage was clearly visible on the produced results enabling asset owner to make calculated decisions on the pipelines safety, maintenance and operations.

  3. [The ACCOMPLISH trial: are results really unexpected?].

    Science.gov (United States)

    Waeber, Bernard; Feihl, François

    2009-01-07

    The ACCOMPLISH trial consists of a randomized morbidity-mortality study involving 11506 hypertensive patients at high cardiovascular risk, randomly allocated to a fixed dose combination containing an angiotensin converting enzyme inhibitor (B, benazepril) and either a calcium antagonist (A, amlodipine) or a diuretic (HCTZ, hydrochlorothiazide). The target blood pressure (< 140/90 mmHg) was achieved after a 6 month titration period in 75.4% of patients receiving B+A, versus 72.4% in those on B + HCTZ. Over a mean follow-up of 3 years, the B + A drug regimen was found to reduce significantly more effectively the relative risk cardiovascular mortality (-20%), fatal and non fatal myocardial infarction (-22%) and coronary revascularization (-14%), appearing therefore particularly effective to prevent complications due to myocardial ischemia.

  4. 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.

  5. Factors associated with results and conclusions of trials of thiazolidinediones.

    Directory of Open Access Journals (Sweden)

    Gail Rattinger

    Full Text Available BACKGROUND: When a sponsor funds a study of two competing drugs in a head-to-head comparison, the results and conclusions are likely to favor the sponsor's drug. Thiazolidinediones, oral medications used for the treatment of type 2 diabetes, are one of the most costly choices of oral anti-diabetic medications, yet they do not demonstrate clinically relevant differences in achieving lower glycosylated hemoglobin levels compared to other oral antidiabetic drugs. Our aim is to examine associations between research funding source, study design characteristics aimed at reducing bias, and other factors with the results and conclusions of randomized controlled trials (RCTs of thiazolidinediones compared to other oral hypoglycemic agents. METHODS AND FINDINGS: This is a cross-sectional study of 61 published RCTs comparing a thiazolidinedione (glitazone to another anti-diabetic drug or placebo for treatment of type 2 diabetes. Data on study design characteristics, funding source, author's financial ties, results for primary outcomes, and author conclusions were extracted. Univariate logistic regression identified associations between independent variables and results and conclusions that favored the glitazone. Of the RCTs, 59% (36/61 were funded by industry, 39% (24/61 did not disclose any funding. Common study design weaknesses included inadequate blinding and lack of concealment of allocation. Trials that reported favorable glycemic control results for the glitazone were more likely to have adequate blinding (OR (95% CI = 5.42 (1.46, 21.19, p = 0.008 and have a corresponding author with financial ties to the glitazone manufacturer (OR (95% CI = 4.12 (1.05, 19.53; p = 0.04. Trials with conclusions favoring the glitazone were less likely to be funded by a comparator drug company than a glitazone company (OR (95% CI = 0.026 (0, 0.40, p = 0.003 and less likely to be published in journals with higher impact factors (OR (95% CI = 0.79 (0.62, 0.97, p = 0

  6. 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)

  7. 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

  8. 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.

  9. 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.

  10. Shutdown dose rate assessment with the Advanced D1S method: Development, applications and validation

    Energy Technology Data Exchange (ETDEWEB)

    Villari, R., E-mail: rosaria.villari@enea.it [Associazione EURATOM-ENEA sulla Fusione, Via Enrico Fermi 45, 00044 Frascati, Rome (Italy); Fischer, U. [Karlsruhe Institute of Technology KIT, Institute for Neutron Physics and Reactor Technology, Hermann-von-Helmholtz-Platz 1, 76344 Eggenstein-Leopoldshafen (Germany); Moro, F. [Associazione EURATOM-ENEA sulla Fusione, Via Enrico Fermi 45, 00044 Frascati, Rome (Italy); Pereslavtsev, P. [Karlsruhe Institute of Technology KIT, Institute for Neutron Physics and Reactor Technology, Hermann-von-Helmholtz-Platz 1, 76344 Eggenstein-Leopoldshafen (Germany); Petrizzi, L. [European Commission, DG Research and Innovation K5, CDMA 00/030, B-1049 Brussels (Belgium); Podda, S. [Associazione EURATOM-ENEA sulla Fusione, Via Enrico Fermi 45, 00044 Frascati, Rome (Italy); Serikov, A. [Karlsruhe Institute of Technology KIT, Institute for Neutron Physics and Reactor Technology, Hermann-von-Helmholtz-Platz 1, 76344 Eggenstein-Leopoldshafen (Germany)

    2014-10-15

    Highlights: Development of Advanced-D1S for shutdown dose rate calculations; Recent applications of the tool to tokamaks; Summary of the results of benchmarking with measurements and R2S calculations; Limitations and further development. Abstract: The present paper addresses the recent developments and applications of Advanced-D1S to the calculations of shutdown dose rate in tokamak devices. Results of benchmarking with measurements and Rigorous 2-Step (R2S) calculations are summarized and discussed as well as limitations and further developments. The outcomes confirm the essential role of the Advanced-D1S methodology and the evidence for its complementary use with the R2Smesh approach for the reliable assessment of shutdown dose rates and related statistical uncertainties in present and future fusion devices.

  11. 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

  12. 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.

  13. Reporting of positive results in randomized controlled trials of mindfulness-based mental health interventions

    NARCIS (Netherlands)

    Coronado-Montoya, S.; Levis, A.W.; Kwakkenbos, C.M.C.; Steele, R.J.; Turner, E.H.; Thombs, B.D.

    2016-01-01

    Background A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-bas

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

    DEFF Research Database (Denmark)

    Lynge, Elsebeth; Rebolj, Matejka

    2009-01-01

    for each extra detected CIN2+ case; although, in another trial, this number was 49 in women > or =35 years of age. The outcome of HPV testing versus cytological testing depends not only on the relative accuracy of the primary test but also on how radical the different triage procedures are. In two trials......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...... testing increased the detection of cervical intraepithelial neoplasia (CIN) grade 2+. Detection of CIN3+ was significantly increased in two trials (relative risks [RRs] 1.70 and 2.26), but not in three other trials (RRs 1.03, 1.09 and 1.31). In three trials, seven extra women had a false-positive test...

  15. Positive results for drug combo in I-SPY 2 trial.

    Science.gov (United States)

    2014-02-01

    In results from one part of the I-SPY 2 trial announced at the 2013 San Antonio Breast Cancer Symposium, neoadjuvant veliparib plus carboplatin improved outcomes for women with triple-negative breast cancer.

  16. Prospective registration and results disclosure of clinical trials in the Americas: a roadmap toward transparency.

    Science.gov (United States)

    Krleža-Jeriç, Karmela; Lemmens, Trudo; Reveiz, Ludovic; Cuervo, Luis Gabriel; Bero, Lisa Anne

    2011-07-01

    The objective of this article is to propose a roadmap toward transparency of clinical trials in the Americas by their prospective registration and results disclosure. This will broaden access to more complete and accurate data and facilitate evidence-informed decision-making and participation in research. Consequently, it should have a positive impact on people's health and should promote trust in health research. Existing initiatives were identified, registration of trials was analyzed following the World Health Organization (WHO) standards on trial registration, and a roadmap is proposed to address the gaps in advancing transparency. The analysis shows that, in spite of numerous regional and country initiatives, clinical trials taking place in nonEnglish-speaking parts of the Americas are underregistered. A roadmap is proposed to enhance research governance and good research practice by improving the transparency of clinical trials. The proposed roadmap includes strategies for implementing WHO international standards for trial registration, for developing international standards of public disclosure of trial results, and for a potential role of the Pan American Health Organization.

  17. 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

  18. Surgery versus prolonged conservative treatment for sciatica: 5-year results of a randomised controlled trial

    OpenAIRE

    Lequin, Michiel B.; Verbaan, Dagmar; Jacobs, Wilco C. H.; Brand, Ronald; Gerrit J. Bouma; Vandertop, William P.; Peul, Wilco C; ,

    2013-01-01

    Objective This study describes the 5 years’ results of the Sciatica trial focused on pain, disability, (un)satisfactory recovery and predictors for unsatisfactory recovery. Design A randomised controlled trial. Setting Nine Dutch hospitals. Participants Five years’ follow-up data from 231 of 283 patients (82%) were collected. Intervention Early surgery or an intended 6 months of conservative treatment. Main outcome measures Scores from Roland disability questionnaire, visual analogue scale (V...

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

    Directory of Open Access Journals (Sweden)

    Smith Laurie W

    2010-03-01

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

  20. Is fish oil good or bad for heart disease? Two trials with apparently conflicting results.

    Science.gov (United States)

    Burr, M L; Dunstan, F D J; George, C H

    2005-07-01

    Two successive randomized trials examined the effect of an increased intake of fatty fish, or the use of fish oil supplements, in reducing mortality in men with heart disease. The Diet and Reinfarction Trial (DART) was conducted in 2033 men who were recovering from acute myocardial infarction (MI). Those who were advised to eat fatty fish (or who opted to take fish oil capsules instead) had a 29% reduction in all-cause mortality over the following two years compared with those not so advised. The effect appeared in the first few months of the trial. The Diet and Angina Randomized Trial (DART 2) involved 3114 men with stable angina. Advice to eat fatty fish did not reduce mortality, and taking fish oil capsules was associated with a higher risk of cardiac and sudden death. The adverse effects of fish or fish oil were restricted to men not taking beta-blockers or dihydropyridine calcium-channel blockers, and were greater in those taking digoxin. Evidence from other sources strongly suggests an anti-arrhythmic action of fish oil, particularly after MI or in the presence of acute ischemia. The apparently conflicting results of the two trials may reflect different actions of n-3 fatty acids in acute and chronic conditions, together with different effects of eating fish and taking fish oil capsules. A mechanism is proposed that could account for these findings.

  1. 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.

  2. Podcast Lectures as a Primary Teaching Technology: Results of a One-Year Trial

    Science.gov (United States)

    Taylor, Mark Zachary

    2009-01-01

    How useful are podcasts in the political science classroom? Some educators argue that podcasts will revolutionize education; others are less convinced. However, to date, the evidence on podcasts has been slim. This article reports the results of a year-long trial using podcasts to aid in teaching political science to undergraduates at a research…

  3. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Koo John

    2003-10-01

    Full Text Available Abstract Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome measures that were used in the trials – the Dermatology Life Quality Index (DLQI, the Psoriasis Symptom Assessment (PSA Scale, and two itch measures, a Visual Analog Scale (VAS and the National Psoriasis Foundation (NPF itch measure. Methods Subjects aged 18 to 70 years with moderate to severe psoriasis for at least 6 months were recruited into the two clinical trials (n = 1095. Internal consistency reliability was evaluated for all patient reported outcomes at baseline and at 12 weeks. Construct validity was evaluated by relations among the different patient reported outcomes and between the patient reported outcomes and the clinical assessments (Psoriasis Area and Severity Index; Overall Lesion Severity Scale; Physician's Global Assessment of Change assessed at baseline and at 12 weeks, as was the change over the course of the 12 week portion of the trial. Results Internal consistency reliability ranged from 0.86 to 0.95 for the patient reported outcome measures. The patient reported outcome measures were all shown to have significant construct validity with respect to each other and with respect to the clinical assessments. The four measures also demonstrated significant responsiveness to change in underlying clinical status of the patients over the course of the trial, as measured by the independently assessed clinical outcomes. Conclusions The DLQI, the PSA, VAS, and the NPF are considered useful tools for the measurement of dermatology

  4. Results of a randomized trial in children with Acute Myeloid Leukaemia : Medical Research Council AML12 trial

    NARCIS (Netherlands)

    Gibson, Brenda E. S.; Webb, David K. H.; Howman, Andrew J.; De Graaf, Siebold S. N.; Harrison, Christine J.; Wheatley, Keith

    2011-01-01

    The Medical Research Council Acute Myeloid Leukaemia 12 (MRC AML12) trial (children) addressed the optimal anthracenedione/anthracycline in induction and the optimal number of courses of consolidation chemotherapy. 504 children (

  5. 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.

  6. 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

  7. 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.

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

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    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.

  9. 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...

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

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    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

  11. Influence of trial design, heterogeneity and regulatory environment on the results of clinical trials: An appraisal in the context of recent trials on acute stroke intervention

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    P R Srijithesh

    2014-01-01

    Full Text Available The outcome of randomized controlled trials can vary depending on the eligibility criteria of the patients entering into the trial, as well as the heterogeneity of the eligible population and/or the interventions. If the subject population and/or interventions are heterogeneous, the final outcome of the trial depends on the degree of concordance of effects of the subgroups of interventions on the subgroups of the subject population. The considerations that go into the calculation of sample size and determination of the study stopping rules also would affect the nature of the outcome of the study. In this paper we try to examine these phenomena with respect to the recent trials on endovascular therapy in acute ischemic stroke.

  12. 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.

  13. What every urologist should know about surgical trials Part I: Are the results valid?

    Directory of Open Access Journals (Sweden)

    Sohail Bajammal

    2008-01-01

    Full Text Available Surgical interventions have inherent benefits and associated risks. Before implementing a new therapy, we should ascertain the benefits and risks of the therapy, and assure ourselves that the resources consumed in the intervention will not be exorbitant. Materials and Methods: We suggest a three-step approach to the critical appraisal of a clinical research study that addresses a question of therapy. Readers should ask themselves the following three questions: Are the study results valid? What are the results? And can I apply them to the care of an individual patient? This first review article on surgical trials will address the question as to whether we consider a study valid or not. Results: Once the reader has found an article of interest on a urological intervention, it is necessary to assess the quality of the evidence. According to the hierarchy of evidence, a randomized controlled trial is the study design which is the most likely to provide an unbiased estimate of the truth. Important methodological criteria which characterize a high-quality randomized trial include description of allocation concealment, blinding, intention-to-treat analysis, and completeness of follow-up. Failure of investigators to apply these principles may raise concerns about the validity of the study results, thereby making its finding irrelevant. Conclusion: Assessing the validity of a given study is a critical first step when evaluating a clinical research study. Making this process explicit with guidelines to assess the strength of the available evidence serves to improve patient care. It will also allow urologists to defend therapeutic interventions, based on available evidence and not anecdotes.

  14. 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

  15. Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models

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    Singla NK

    2014-12-01

    Full Text Available Neil K Singla,1 Jacques E Chelly,2 David R Lionberger,3 Joseph Gimbel,4 Luis Sanin,5 Jonathan Sporn,5 Ruoyong Yang,5 Raymond Cheung,5 Lloyd Knapp,6 Bruce Parsons5 1Lotus Clinical Research, Pasadena, CA, USA; 2Division of Acute Interventional Perioperative Pain, Department of Anesthesiology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; 3Department of Orthopedic Surgery, Baylor College of Medicine, Houston, TX, USA; 4Arizona Research Center, Phoenix, AZ, USA; 5Pfizer Inc., New York, NY, USA; 6Pfizer Inc., New London, CT, USA Purpose: To evaluate the efficacy and safety of pregabalin (150 or 300 mg/d as an adjunctive therapy for the treatment of postoperative pain. Patients and methods: This study reports findings from three separate, multicenter, randomized, double-blind, placebo-controlled trials of adjunctive pregabalin for the treatment of postoperative pain. Patients underwent one of three categories of surgical procedures (one procedure per study: elective inguinal hernia repair (post-IHR; elective total knee arthroplasty (post-TKA; or total abdominal hysterectomy (posthysterectomy. The primary endpoint in each trial, mean worst pain over the past 24 hours, was assessed 24 hours post-IHR and posthysterectomy, and 48 hours post-TKA. Patients rated their pain on a scale from 0 to 10, with higher scores indicating greater pain severity. Results: In total, 425 (post-IHR, 307 (post-TKA, and 501 (posthysterectomy patients were randomized to treatment. There were no statistically significant differences between the pregabalin and placebo groups with respect to the primary endpoint in any of the three trials. The least squares mean difference in worst pain, between 300 mg/d pregabalin and placebo, was -0.7 (95% confidence interval [CI] =-1.4, -0.1; Hochberg adjusted P=0.067 post-IHR; -0.34 (95% CI =-1.07, 0.39; P=0.362 post-TKA; and -0.2 (95% CI =-0.66, 0.31; P=0.471 posthysterectomy. Conclusion: There were no significant differences

  16. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

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

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    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

  18. Laser immunotherapy: initial results from a human breast cancer pilot trial

    Science.gov (United States)

    Hode, Tomas; Guerra, Maria C.; Ferrel, Gabriela L.; Lunn, John A.; Adelsteinsson, Orn; Nordquist, Robert E.; Chen, Wei R.

    2010-02-01

    Laser Immunotherapy is an experimental treatment modality for late-stage, metastatic tumors, which targets solid primary and/or secondary tumors and utilizes an autologous vaccine-like approach to stimulate immune responses. Specifically, laser immunotherapy combines laser-induced in situ tumor devitalization with an immunoadjuvant for local immunostimulation. Here we report the initial results from a human breast cancer pilot trial with laser immunotherapy. Six stage III and IV cancer patients were treated, all of which were considered to be out of all other options, and preliminary data at the three-month examination are presented. The immediate goal of the trial was to determine the patient tolerance and the toxicity of the therapy, the optimal dose for the alteration of the course of the disease, and the reduction of the tumor burden. Each patient was individually evaluated for toxicity tolerance through physical exams and by appropriate supplemental and routine laboratory tests. Observable tumors in patients were followed with physical examination and radiological evaluations. Treatment efficacy was judged by the size and number of local and distant metastases before and after treatment.

  19. 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.

  20. Reducing discards without reducing profit: Free gear choice in a Danish result-based management trial

    DEFF Research Database (Denmark)

    Mortensen, Lars O.; Ulrich, Clara; Qvist Eliasen, Søren

    2016-01-01

    on the means used to obtain these catches (a move towards results-based management). To investigate the potentials and challenges that these paradigm shifts give rise to, a 6-months ‘unrestricted gear’ trial was performed in Denmark in 2015,. Twelve trawlers of different size, rigging, fishing area and target...... species were challenged to test their own solutions to reduce unwanted bycatch and/or choke species, while maintaining their profitability. Fully documented fishery (FDF) was required, including electronic monitoring, self-estimation of discards and haul-by-haul catch documentation. Fishers’ participation......, where unwanted catches could be reduced to some extent without negative effects on economic viability. Some practical implementation challenges were nevertheless encountered, which are discussed in the perspective of implementing results-based management at full scale....

  1. Managing High-Altitude Pulmonary Edema with Oxygen Alone: Results of a Randomized Controlled Trial.

    Science.gov (United States)

    Yanamandra, Uday; Nair, Velu; Singh, Surinderpal; Gupta, Amul; Mulajkar, Deepak; Yanamandra, Sushma; Norgais, Konchok; Mukherjee, Ruchira; Singh, Vikrant; Bhattachar, Srinivasa A; Patyal, Sagarika; Grewal, Rajan; Chopra, Bhushan

    2016-12-01

    Yanamandra, Uday, Velu Nair, Surinderpal Singh, Amul Gupta, Deepak Mulajkar, Sushma Yanamandra, Konchok Norgais, Ruchira Mukherjee, Vikrant Singh, Srinivasa A. Bhattachar, Sagarika Patyal, and Rajan Grewal. High-altitude pulmonary edema management: Is anything other than oxygen required? Results of a randomized controlled trial. High Alt Med Biol. 17:294-299, 2016.-Treatment strategies for management of high-altitude pulmonary edema (HAPE) are mainly based on the observational studies with only two randomized controlled trials, thus the practice is very heterogeneous and individualized as per the choice of treating physician. To compare the response to different modalities of therapy in patients with HAPE in a randomized controlled manner. We conducted an open-label, randomized noninferiority trial to compare three modalities of therapy (Therapy 1: supplemental O2 with oral dexamethasone 8 mg q8 hours [n = 42], Therapy 2: supplemental O2 with sustained release oral nifedipine 20 mg q8 hours [n = 41], and Therapy 3: only supplemental O2 [n = 50]). Bed rest was mandated in all patients. The study was conducted in a cohort of previously healthy young lowlander males at an altitude of 3500 m. Baseline characteristics of the patients were comparable in the study arms. Complete response was defined as clinical and radiological resolution of features of HAPE, no oxygen dependency, a normal 6-minute walk test (6MWT) on 2 consecutive days, and normal two-dimensional echocardiography. Results were compared by analysis of variance using SPSS version 16.0. There was no statistical difference in duration of therapy to complete response between the three groups (Therapy 1: 8.1 ± 4.0 days, Therapy 2: 6.7 ± 3.9 days, Therapy 3: 6.8 ± 3.2 days; p = 0.15). There were no deaths in any of the groups. We conclude that oxygen and bed rest alone are adequate therapy for HAPE and that adjuvant pharmacotherapy with either dexamethasone or nifedipine

  2. Preemptive Treatment of Nausea and Vomiting of Pregnancy: Results of a Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Caroline Maltepe

    2013-01-01

    Full Text Available Objectives. To determine whether the initiation of treatment (preemptive treatment before the symptoms of nausea and vomiting of pregnancy (NVP versus when the symptoms begin can improve the outcome in patients at a high risk for recurrence of severe NVP. Study Design. Prospective, randomized controlled trial. Results. Preemptive therapy conferred a significant reduction in HG as compared to the previous pregnancy (P=0.047. In the preemptive arm, there were 2.5-fold fewer cases of moderate-severe cases of NVP than those in the control group (15.4% versus 39.13% in the first 3 weeks of NVP (P=0.05. In the preemptive group, significantly more women had their NVP resolved before giving birth (78.2% versus 50% (P<0.002. Conclusions. Preemptive treatment with antiemetics is superior to the treatment that starts only when the symptoms have already occurred in decreasing the risk of severe forms of NVP.

  3. Molecular breast imaging: First results from Italian-National-Institute-of-Health clinical trials

    Science.gov (United States)

    Cusanno, F.; Cisbani, E.; Colilli, S.; Fratoni, R.; Garibaldi, F.; Giuliani, F.; Gricia, M.; Lucentini, M.; Magliozzi, M. L.; Santanvenere, F.; Torrioli, S.; Cinti, M. N.; Pani, R.; Pellegrini, R.; Simonetti, G.; Schillaci, O.; Del Vecchio, S.; Salvatore, M.; Majewski, S.; De Vincentis, G.; Scopinaro, F.

    2007-02-01

    Dedicated high resolution detectors are needed for detection of small tumors by molecular imaging with radionuclides. Absorptive collimation are typically used for imaging single photon emitters, but it results in a strong reduction in efficiency. Systems based on electronic collimation offer higher efficiency but they are complex and expensive. In case of scintimammography, dual-head detectors increase sensitivity and cancel out the dependence of the lesion depth. In the system presented here, pixellated scintillator arrays (NaI:Tl) were coupled to arrays of PSPMT's, HPK H8500 Flat Panel. A dual-head detector having field of view of 100×100 mm 2 and 150×200 mm 2 were designed and built. The electronic system allows readout of all the anode pad signals. First clinical trials, performed in the framework of the Scintimammography project of Italian National Institute of Health and University of Tor Vergata in Rome, and University of Naples, are presented.

  4. [Hernia repair and local anesthesia. Results of a controlled randomized clinical trial].

    Science.gov (United States)

    Milone, F; Salvatore, G; Leongito, M; Milone, M

    2010-01-01

    In the past, general and spinal anesthesia were used for hernia surgery, but nowadays local anesthesia has become the method of choice for hernia repair, especially in outpatient patients. The one-day surgery is sufficient in the management of this pathology. The advantages of local anesthesia are simplicity, safety, extended postoperative analgesia, early mobilization, lack post-anesthesia effects, and low costs. From January 2004 to December 2008 we observed 297 male patients with inguinal hernia. These patients were divided, with rigorous chronological order of hospital admission, in two study groups, different for anesthetic techniques used. Our controlled randomized clinical trial examines the effectiveness of local anesthesia to reduce the time of hospitalization, without alteration of results, and particularly the degree of satisfaction of patients surgical treated for inguinal hernia.

  5. Interim Results from the International Trial of Second Sight’s Visual Prosthesis

    Science.gov (United States)

    Humayun, Mark S.; Dorn, Jessy D.; Cruz, Lyndon da; Dagnelie, Gislin; Sahel, José-Alain; Stanga, Paulo E.; Cideciyan, Artur V.; Duncan, Jacque L.; Eliott, Dean; Filley, Eugene; Ho, Allen C.; Santos, Arturo; Safran, Avinoam B.; Arditi, Aries; Del Priore, Lucian V.; Greenberg, Robert J.

    2011-01-01

    Purpose This study evaluates the Argus™ II Retinal Prosthesis System in blind subjects with severe outer retinal degeneration. Design The study design is a single arm, prospective, multicenter clinical trial. Participants Thirty subjects were enrolled in the United States and Europe between 6 June 2007 and 11 August 2009. All subjects were followed for a minimum of six months and up to 2.7 years. Methods The electronic stimulator and antenna of the implant was sutured onto the sclera using an encircling silicone band. Next, a pars plana vitrectomy was performed and the electrode array and cable were introduced into the eye via a pars plana sclerotomy. The microelectrode array was then tacked to the epiretinal surface. Main Outcome Measures The primary safety endpoint for the trial was the number, severity, and relation of adverse events. Principal performance endpoints were assessments of visual function as well as performance on orientation and mobility tasks. Results Subjects performed statistically better with system ON vs. OFF in the following tasks: object localization (96% of subjects); motion discrimination (57%); and discrimination of oriented gratings (23%). The best recorded visual acuity to date is 20/1260. Subjects’ mean performance on Orientation and Mobility tasks was significantly better when the System was ON vs. OFF. Seventy percent of the patients did not have any serious adverse events (SAEs). The most common SAE reported was either conjunctival erosion or dehiscence over the extraocular implant and was successfully treated in all subjects except in one which required explantation of the device without further complications. Conclusions The long-term safety results of Second Sight’s retinal prosthesis system are acceptable and the majority of subjects with profound visual loss perform better on visual tasks with system than without. PMID:22244176

  6. 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.

  7. Myocardial infarction and left ventricular remodeling: results of the CEDIM trial. Carnitine Ecocardiografia Digitalizzata Infarto Miocardico.

    Science.gov (United States)

    Colonna, P; Iliceto, S

    2000-02-01

    Left ventricular dilatation after acute myocardial infarction (MI) is a powerful predictor of progressive functional deterioration, culminating in heart failure and death. The most important determinants of post-MI left ventricular remodeling are the size of the infarct, the degree of residual stenosis in the infarct-related artery, and the viability of the infarct zone. In addition to reperfusion therapy and angiotensin-converting enzyme inhibition, metabolic intervention with L-carnitine may represent a therapeutic approach for preventing left ventricular dilatation and preserving cardiac function. Ongoing studies with early metabolic intervention with carnitine in the acute phase of infarction may prove successful in protecting the microcirculation against ischemic damage and enhancing its ability to respond to blood flow resumption. The results of the multicenter, randomized, double-blind Carnitine Ecocardiografia Digitalizzata Infarto Miocardico (CEDIM) trial suggest that the early and long-term administration of L-carnitine attenuates progressive left ventricular dilatation after acute anterior MI. Results show significant, consistent reductions in end-diastolic volume and end-systolic volume in patients who received L-carnitine compared with placebo. The ongoing CEDIM-2 trial (projected 4000 patients with acute MI) will assess the efficacy of L-carnitine in reducing the combined incidence of death and heart failure at 6 months. In addition to standard reperfusion therapy and angiotensin-converting enzyme inhibition, metabolic intervention with L-carnitine may be a therapeutic approach for preventing left ventricular dilatation and preserving cardiac function by limiting infarct size, decreasing residual stenosis in the infarct-related artery, and increasing viability of the infarct zone.

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

    Directory of Open Access Journals (Sweden)

    Didier Dequanter

    2010-06-01

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

  9. An emergency clinical pathway for stroke patients – results of a cluster randomised trial (isrctn41456865

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    Ferri Marica

    2009-01-01

    Full Text Available Abstract Background Emergency Clinical Pathways (ECP for stroke have never been tested in randomized controlled trials (RCTs. Objective To evaluate the effectiveness of an ECP for stroke patients in Latium (Italy emergency system. Methods cluster-RCT designed to compare stroke patient referrals by Emergency Medical Service (EMS and Emergency Room (ER health professionals trained in the ECP, with those of non-trained EMS and ER controls. Primary outcome measure was the proportion of eligible (aged ≤ 80 and symptom onset ≤ 6 hours stroke patients referred to a stroke unit (SU. Intention to treat (ITT and per-protocol (PP analyses were performed, and risk ratios (RR adjusted by age, gender and area, were calculated. Results 2656 patients in the intervention arm and 2239 in the control arm required assistance; 78.3% of the former and 80.6% of the latter were admitted to hospitals, and respectively 74.8% and 78.3% were confirmed strokes. Of the eligible confirmed strokes, 106/434 (24.4% in the intervention arm and 43/328 (13.1% in the control arm were referred to the SU in the ITT analysis (RR = 2.01; 95% CI: 0.79–4.00, and respectively 105/243 (43.2% and 43/311 (13.8% in the PP analysis (RR = 3.21; 95%CI: 1.62–4.98. Of patients suitable for i.v. thrombolysis, 15/175 (8.6% in the intervention arm and 2/115 (1.7% in the control arm received thrombolysis (p = 0.02 in the ITT analysis, and respectively 15/99 (15.1% and 2/107 (1.9%(p = 0.001 in the PP analysis. Conclusion Our data suggest potenti efficiency and feasibility of an ECP. The integration of EMS and ERs with SU networks for organised acute stroke care is feasible and may ameliorate the quality of care for stroke patients. Trial registration Current Controlled Trials (ISRCTN41456865.

  10. 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

  11. 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...... (rosiglitazone and pioglitazone) on cardiovascular outcomes and the effects of vitamin D (cholecalciferol) on cancers and mortality....

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

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    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.

  13. 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.

  14. Cognitive Enhancement Therapy in substance misusing schizophrenia: results of an 18-month feasibility trial.

    Science.gov (United States)

    Eack, Shaun M; Hogarty, Susan S; Greenwald, Deborah P; Litschge, Maralee Y; McKnight, Summer A F; Bangalore, Srihari S; Pogue-Geile, Michael F; Keshavan, Matcheri S; Cornelius, Jack R

    2015-02-01

    Substance use is a frequent problem in schizophrenia, and although many substance misusing patients with the disorder also experience considerable cognitive impairments, such individuals have been routinely excluded from clinical trials of cognitive remediation that could support their functional and addiction recoveries. This study conducted a small-scale feasibility trial of Cognitive Enhancement Therapy (CET) in substance misusing schizophrenia patients to assess the feasibility and efficacy of implementing comprehensive neurocognitive and social-cognitive remediation in this population. A total of 31 schizophrenia outpatients meeting addiction severity criteria for alcohol and/or cannabis use were randomized to 18months of CET or usual care. Feasibility findings indicated high degrees of satisfaction with CET, but also presented significant challenges in the recruitment and retention of substance misusing patients, with high levels of attrition (50%) over the study period, primarily due to positive symptom exacerbation. Intent-to-treat efficacy analyses showed large and significant improvements in neurocognition (d=.86), social cognition (d=1.13), and social adjustment (d=.92) favoring CET. Further, individuals treated with CET were more likely to reduce alcohol use (67% in CET vs. 25% in usual care) during treatment (p=.021). These results suggest that once engaged and stabilized, CET is a feasible and potentially effective treatment for cognitive impairments in patients with schizophrenia who misuse alcohol and/or cannabis. Substance misusing patients who are able to engage in treatment may be able to benefit from cognitive remediation, and the treatment of cognitive impairments may help improve substance use outcomes among this underserved population.

  15. Vismodegib for the treatment of basal cell carcinoma: results and implications of the ERIVANCE BCC trial.

    Science.gov (United States)

    Dessinioti, Clio; Plaka, Michaela; Stratigos, Alexander J

    2014-05-01

    The need for effective treatment of patients with locally advanced or metastatic basal cell carcinoma (BCC), in conjunction with major advances in the elucidation of the molecular basis of this tumor has led to the advent of new targeted therapies - namely, hedgehog inhibitors. The rationale for their use in patients with advanced BCC is based on their inhibitory effect on the hedgehog pathway, which is aberrantly activated in BCCs due to mutations of its primary components, PTCH1 and SMO genes. Vismodegib (GDC-0449) is an orally bioavailable hedgehog pathway inhibitor that selectively inhibits SMO. The ERIVANCE BCC study is a Phase II, international, multicenter clinical trial evaluating the efficacy and safety of vismodegib 150 mg once daily in patients with locally advanced or metastatic BCC. Vismodegib has been approved for the treatment of adult patients with metastatic BCC, or with locally advanced BCC that has recurred following surgery or who are not candidates for surgery or radiation therapy. This article will outline the rationale, design and available results from the ERIVANCE BCC study and discuss the clinical implications of vismodegib in the management of patients with BCC. Challenges regarding vismodegib use include the recurrence of BCC after drug discontinuation, the development of acquired resistance, the dramatic efficacy in patients with Gorlin syndrome, and class-related drug toxicity. Ongoing clinical trials aim to explore the role of vismodegib in the neoadjuvant setting prior to surgery, the potential use of alternate dosing regimens in order to limit chronic adverse events, as well as the identification of patients with BCC that are more likely to respond to this targeted therapy based on genotypic and/or phenotypic characteristics.

  16. Adjuvant therapy for osteosarcoma in dogs: results of randomized clinical trials using combined liposome-encapsulated muramyl tripeptide and cisplatin.

    Science.gov (United States)

    Kurzman, I D; MacEwen, E G; Rosenthal, R C; Fox, L E; Keller, E T; Helfand, S C; Vail, D M; Dubielzig, R R; Madewell, B R; Rodriguez, C O

    1995-12-01

    Two randomized, double-blind clinical trials in dogs with spontaneous appendicular osteosarcoma treated with combination chemoimmunotherapy are reported. In both trials, dogs without overt metastasis underwent complete amputation of the affected limb. In trial 1, 40 dogs were treated with cisplatin chemotherapy [(CDDP), 70 mg/m2 i.v. every 28 days x 4]. Following CDDP, dogs without evidence of overt metastasis (n = 25) were randomized to receive liposome-encapsulated muramyl tripeptide phosphatidylethanolamine ](L-MTP-PE), 2 mg/m2 i.v.) or placebo liposomes (lipid equivalent) twice weekly for 8 weeks. Of 14 dogs in the placebo group, 13 (93%) died of metastasis; the median survival time was 9.8 months. Of 11 dogs in the L-MTP-PE group, 8 (73%) developed metastasis; the median survival time was 14.4 months, which was significantly longer than that of the placebo group (P trial 2, 64 dogs received CDDP (70 mg/m2 i.v. every 21 days x 4) and were randomized to concurrently receive L-MTP-PE (2 mg/m2 i.v.) twice or once weekly, or placebo liposomes once weekly for 8 weeks. Median survival times were 10.3, 10.5, and 7.6 months, respectively. There were no significant differences among the three treatment groups in trial 2. Survival times for dogs receiving L-MTP-PE in trial 1 were significantly longer than those for dogs in trial 2 that received four doses of CDDP concurrently with twice weekly L-MTP-PE (P trial confirm our previous observation that L-MTP-PE has antimetastatic activity in dogs with osteosarcoma when given following amputation. The results of the second trial demonstrate that there is no survival advantage of administering L-MTP-PE concurrently with CDDP.

  17. Early results of an in vivo trial of ESS in thyroid cancer

    Science.gov (United States)

    Rosen, Jennifer E.; Goukassian, Ilona D.; A'Amar, Ousama M.; Bigio, Irving J.; Lee, Stephanie L.

    2012-02-01

    Introduction: Thyroid cancer is the most common endocrine malignancy. The current gold standard for diagnosis, fine-needle aspiration (FNA) biopsy, yields 10-25% of indeterminate cytology results, leading to patients undergoing thyroidectomy for diagnosis. We assessed the technical potential of a miniaturized in vivo ESS (elastic light scattering spectroscopy) probe, built into an FNA needle assembly, to differentiate benign from malignant thyroid nodules. Methods: Under IRB approval, 15 patients in the endocrine clinic undergoing FNAB of a thyroid nodule had collection of ESS data using our novel miniaturized FNA probe. Using final surgical pathology as our gold standard, data post processing and visual inspection was completed. Results: 225 spectra were grouped and analyzed (120 benign, 30 malignant and 75 from indeterminate cytology). ESS probes demonstrated excellent reproducibility in use. Initial analysis of these preliminary data is promising, indicating distinction of spectral ESS features between malignant and benign conditions. Conclusion(s): An in vivo trial of an invasive miniaturized integrated ESS biopsy probe is acceptable to patients, and collection of ESS data is feasible and reliable. With development of a disease-specific algorithm, ESS could potentially be used as an in-situ real time intra-operative diagnostic tool or as a minimally invasive adjunct to conventional FNA cytology.

  18. 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

  19. 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

  20. Accelerated partial breast irradiation with external beam radiotherapy. First results of the German phase 2 trial

    Energy Technology Data Exchange (ETDEWEB)

    Ott, Oliver J.; Strnad, Vratislav; Stillkrieg, Wilhelm; Fietkau, Rainer [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany); Uter, Wolfgang [University Erlangen-Nuremberg, Dept. of Medical Informatics, Biometry and Epidemiology, Erlangen (Germany); Beckmann, Matthias W. [University Hospital Erlangen, Dept. of Gynecology, Erlangen (Germany)

    2017-01-15

    To evaluate the feasibility and efficacy of external beam three-dimensional (3D) conformal accelerated partial breast irradiation (APBI) for selected patients with early breast cancer. Between 2011 and 2016, 72 patients were recruited for this prospective phase 2 trial. Patients were eligible for APBI if they had histologically confirmed breast cancer or pure ductal carcinoma in situ (DCIS), a tumor diameter ≤3 cm, clear resection margins ≥2 mm, no axillary lymph node involvement, no distant metastases, tumor bed clips, and were aged ≥50 years. Patients were excluded if mammography showed a multicentric invasive growth pattern, or if they had residual diffuse microcalcifications postoperatively, an extensive intraductal component, or vessel invasion. Patients received 3D conformal external beam APBI with a total dose of 38 Gy in 10 fractions in 1-2 weeks. The trial had been registered at the German Clinical Trials Register, DRKS-ID: DRKS00004417. Median follow-up was 25.5 months (range 1-61 months). Local control was maintained in 71 of 72 patients. The 3-year local recurrence rate was 2.1% (95% confidence interval, CI: 0-6.1%). Early toxicity (grade 1 radiodermatitis) was seen in 34.7% (25/72). Late side effects ≥ grade 3 did not occur. Cosmetic results were rated as excellent/good in 96.7% (59/61). APBI with external beam radiotherapy techniques is feasible with low toxicity and, according to the results of the present and other studies, on the way to becoming a standard treatment option for a selected subgroup of patients. (orig.) [German] Untersuchung der Vertraeglichkeit und Sicherheit der externen, 3-D-konformalen akzelerierten Teilbrustbestrahlung (APBI) fuer ausgewaehlte Patientinnen mit einem fruehen Mammakarzinom. Von 2011 bis 2016 wurden 72 Patientinnen in diese prospektive Phase-2-Studie eingebracht. Einschlusskriterien waren ein histologisch gesichertes Mammakarzinom oder DCIS, ein Tumordurchmesser ≤ 3 cm, tumorfreie Resektionsraender ≥ 2

  1. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    OpenAIRE

    Koo John; Thompson Christine; Stone Stephen P; Bresnahan Brian W; Shikiar Richard; Revicki Dennis A

    2003-01-01

    Abstract Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome m...

  2. Effect of prenatal DHA supplementation on the infant epigenome: results from a randomized controlled trial

    OpenAIRE

    van Dijk, Susan J.; Zhou, Jing; Peters, Timothy J; Buckley, Michael; Sutcliffe, Brodie; Oytam, Yalchin; Robert A Gibson; McPhee, Andrew; Yelland, Lisa N; Makrides, Maria; Molloy, Peter L.; Beverly S Muhlhausler

    2016-01-01

    Background Evidence is accumulating that nutritional exposures in utero can influence health outcomes in later life. Animal studies and human epidemiological studies have implicated epigenetic modifications as playing a key role in this process, but there are limited data from large well-controlled human intervention trials. This study utilized a large double-blind randomized placebo-controlled trial to test whether a defined nutritional exposure in utero, in this case docosahexaenoic acid (D...

  3. 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....

  4. 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

  5. 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

  6. 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.)

  7. 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.)

  8. 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.

  9. Xyloglucan for the Treatment of Acute Gastroenteritis in Children: Results of a Randomized, Controlled, Clinical Trial

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    Cătălin Pleșea Condratovici

    2016-01-01

    Full Text Available Background. Xyloglucan, a film-forming agent, improves intestinal mucosa resistance to pathologic damage. The efficacy, safety, and time of onset of the antidiarrheal effect of xyloglucan were assessed in children with acute gastroenteritis receiving oral rehydration solution (ORS. Methods. This randomized, controlled, open-label, parallel-group, multicenter, clinical trial included children (3 months–12 years with acute gastroenteritis of infectious origin. Children were randomized to xyloglucan and ORS, or ORS only, for 5 days. Diarrheal symptoms, including stool number/characteristics, and safety were assessed at baseline and after 2 and 5 days and by fulfillment of a parent diary card. Results. Thirty-six patients (58.33% girls were included (n=18/group. Patients receiving xyloglucan and ORS had better symptom evolution than ORS-only recipients, with a faster onset of action. At 6 hours, xyloglucan produced a significantly greater decrease in the number of type 7 stools (0.11 versus 0.44; P=0.027. At days 3 and 5, xyloglucan also produced a significantly greater reduction in types 6 and 7 stools compared with ORS alone. Xyloglucan plus ORS was safe and well tolerated. Conclusions. Xyloglucan is an efficacious and safe option for the treatment of acute gastroenteritis in children, with a rapid onset of action in reducing diarrheal symptoms. This study is registered with ISRCTN number 65893282.

  10. Relation of depression to perceived social support: results from a randomized adolescent depression prevention trial.

    Science.gov (United States)

    Stice, Eric; Rohde, Paul; Gau, Jeff; Ochner, Chris

    2011-05-01

    Theorists posit that certain behaviors exhibited by depressed individuals (e.g., negative self-statements, dependency, reassurance seeking, inappropriate or premature disclosures, passivity, social withdrawal) reduce social support, yet there have been few experimental tests of this hypothesis. Using data from a randomized depression prevention trial (N=253) involving adolescents (M age=15.5, SD=1.2), we tested whether a cognitive behavioral group intervention that significantly reduced depressive symptoms relative to bibliotherapy and educational brochure control conditions through 2-year follow-up produced improvements in perceived parental and friend social support and whether change in depressive symptoms mediated the effect on change in social support. Cognitive behavioral group participants showed significantly greater increases in perceived friend social support through 1-year follow-up relative to bibliotherapy and brochure controls, but there were no significant effects for perceived parental support. Further, change in depressive symptoms appeared to mediate the effects of the intervention on change in perceived friend support. Results provide experimental support for the theory that depressive symptoms are inversely related to perceived social support, but imply that this effect may be specific to friend vs. parental support for adolescents.

  11. A feasibility study of soft embalmed human breast tissue for preclinical trials of HIFU- preliminary results

    Science.gov (United States)

    Joy, Joyce; Yang, Yang; Purdie, Colin; Eisma, Roos; Melzer, Andreas; Cochran, Sandy; Vinnicombe, Sarah

    2017-03-01

    Breast cancer is the commonest cancer in women in the UK, accounting for 30% of all new cancers in women, with an estimated 49,500 new cases in 20101. With the widespread negative publicity around over-diagnosis and over-treatment of low risk breast cancers, interest in the application of non-invasive treatments such as magnetic resonance imaging (MRI) guided high intensity focused ultrasound (HIFU) has increased. Development has begun of novel US transducers and platforms specifically designed for use with breast lesions, so as to improve the range of breast lesions that can be safely treated. However, before such transducers can be evaluated in patients in clinical trials, there is a need to establish their efficacy. A particular issue is the accuracy of temperature monitoring of FUS with MRI in the breast, since the presence of large amounts of surrounding fat can hinder temperature measurement. An appropriate anatomical model that imposes similar physical constraints to the breast and that responds to FUS in the same way would be extremely advantageous. The aim of this feasibility study is to explore the use of Thiel embalmed cadaveric tissue for these purposes. We report here the early results of laboratory-based experiments sonicating dissected breast samples from a Thiel embalmed soft human cadaver with high body mass index (BMI). A specially developed MRI compatible chamber and sample holder was developed to secure the sample and ensure reproducible sonications at the transducer focus. The efficacy of sonication was first studied with chicken breast and porcine tissue. The experiments were then repeated with the dissected fatty breast tissue samples from the soft-embalmed human cadavers. The sonicated Thiel breast tissue was examined histopathologically, which confirmed the absence of any discrete lesion. To investigate further, fresh chicken breast tissue was embalmed and the embalmed tissue was sonicated with the same parameters. The results confirmed the

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

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    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.

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

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    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

  14. 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

    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...... 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...

  15. Exercise improves quality of life in bariatric surgery candidates: Results from the Bari-Active trial

    Science.gov (United States)

    Bond, Dale S.; Thomas, J. Graham; King, Wendy C.; Vithiananthan, Sivamainthan; Trautvetter, Jennifer; Unick, Jessica L.; Ryder, Beth A.; Pohl, Dieter; Roye, G. Dean; Sax, Harry C.; Wing, Rena R.

    2014-01-01

    OBJECTIVE To examine the impact of a pre-bariatric surgery physical activity intervention (PAI), designed to increase bout-related (≥10-minute) moderate-to-vigorous PA (MVPA), on health-related quality of life (HRQoL). METHODS Analyses included 75 adult participants (86.7% female; BMI=45.0±6.5 kg/m2) who were randomly assigned to 6 weeks of PAI (n=40) or standard pre-surgical care (SC; n=35). PAI received six individual weekly counseling sessions to increase walking exercise. Participants wore an objective PA monitor for 7 days and completed the SF-36 Health Survey at baseline and post-intervention to evaluate bout-related MVPA and HRQoL changes, respectively. RESULTS PAI increased bout-related MVPA from baseline to post-intervention (4.4±5.5 to 21.0±21.4 minutes/day) versus no change (7.9±16.6 to 7.6±11.5 minutes/day) for SC (p=0.001). PAI reported greater improvements than SC on all SF-36 physical and mental scales (p<0.05), except role-emotional. In PAI, better baseline scores on the physical function and general health scales predicted greater bout-related MVPA increases (p<0.05), and greater bout-related MVPA increases were associated with greater post-intervention improvements on the physical function, bodily pain, and general health scales (p<0.05). CONCLUSIONS Increasing PA preoperatively improves physical and mental HRQoL in bariatric surgery candidates. Future studies should examine whether this effect improves surgical safety, weight loss outcomes, and postoperative HRQoL. Trial Registration clinicaltrials.gov Identifier: NCT00962325 PMID:25611582

  16. BIOBEHAVIORAL PROGNOSTIC FACTORS IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE: Results from the INSPIRE-II Trial

    Science.gov (United States)

    Blumenthal, James A.; Smith, Patrick J.; Durheim, Michael; Mabe, Stephanie; Emery, Charles F.; Martinu, Tereza; Diaz, Philip T.; Babyak, Michael; Welty-Wolf, Karen; Palmer, Scott

    2015-01-01

    Objective To examine the prognostic value of select biobehavioral factors in patients with chronic obstructive pulmonary disease (COPD) in a secondary analysis of participants from the INSPIRE-II trial. Methods Three hundred twenty six outpatients with COPD underwent assessments of pulmonary function, physical activity, body mass index, inflammation, pulmonary symptoms, depression, and pulmonary quality of life, and were followed for up to 5.4 years for subsequent clinical events. The prognostic value of each biobehavioral factor, considered individually and combined, also was examined in the context of existing Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011 risk stratification. Results Sixty-nine individuals experienced a hospitalization or died over a mean follow-up time period of 2.4 (interquartile range = 1.6) years. GOLD classification was associated with an increased risk of clinical events (HR = 2.72 [95% CI 1.63, 4.54], per stage); Six Minute Walk (HR = 0.50 [0.34, 0.73] per 500 feet), total steps (HR = 0.82 [0.71, 0.94] per 1,000 steps), hsC-reactive protein (HR = 1.44 [1.01, 2.06] per 4.5 mg/L), depression (HR = 1.12 [1.01, 1.25] per 4 points), and pulmonary quality of life (HR = 1.73 [1.14, 2.63] per 25 points) were each predictive over and above the GOLD assessment. However, only GOLD group and Six Minute Walk were predictive of all-cause mortality and COPD hospitalization when all biobehavioral variables were included together in a multivariable model. Conclusion Biobehavioral factors provide added prognostic information over and above measures of COPD severity in predicting adverse events in patients with COPD. PMID:26780299

  17. 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…

  18. 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

  19. 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

  20. 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

  1. 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…

  2. 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)…

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

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    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.

  4. The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial

    Science.gov (United States)

    Arean, Patricia A; Hallgren, Kevin A; Jordan, Joshua T; Gazzaley, Adam; Atkins, David C; Heagerty, Patrick J

    2016-01-01

    Background Mobile apps for mental health have the potential to overcome access barriers to mental health care, but there is little information on whether patients use the interventions as intended and the impact they have on mental health outcomes. Objective The objective of our study was to document and compare use patterns and clinical outcomes across the United States between 3 different self-guided mobile apps for depression. Methods Participants were recruited through Web-based advertisements and social media and were randomly assigned to 1 of 3 mood apps. Treatment and assessment were conducted remotely on each participant’s smartphone or tablet with minimal contact with study staff. We enrolled 626 English-speaking adults (≥18 years old) with mild to moderate depression as determined by a 9-item Patient Health Questionnaire (PHQ-9) score ≥5, or if their score on item 10 was ≥2. The apps were (1) Project: EVO, a cognitive training app theorized to mitigate depressive symptoms by improving cognitive control, (2) iPST, an app based on an evidence-based psychotherapy for depression, and (3) Health Tips, a treatment control. Outcomes were scores on the PHQ-9 and the Sheehan Disability Scale. Adherence to treatment was measured as number of times participants opened and used the apps as instructed. Results We randomly assigned 211 participants to iPST, 209 to Project: EVO, and 206 to Health Tips. Among the participants, 77.0% (482/626) had a PHQ-9 score >10 (moderately depressed). Among the participants using the 2 active apps, 57.9% (243/420) did not download their assigned intervention app but did not differ demographically from those who did. Differential treatment effects were present in participants with baseline PHQ-9 score >10, with the cognitive training and problem-solving apps resulting in greater effects on mood than the information control app (χ22=6.46, P=.04). Conclusions Mobile apps for depression appear to have their greatest impact on

  5. Espresso coffee for the treatment of somnolence in Parkinson’s disease: results of n-of-1 trials

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    Joaquim J Ferreira

    2016-03-01

    Full Text Available There is limited information available concerning the treatment of daytime somnolence associated with Parkinson’s disease (PD; the most frequently applied therapeutic strategies include decreasing the dose of dopamine agonists or adding potential wake-promoting agents. There is recent data from a placebo-controlled trial concluding on a non-significant trend in favor of caffeine. We aimed to evaluate the efficacy of espresso-coffee in the treatment of daytime somnolence in PD. To evaluate the efficacy of espresso-coffee in the treatment of daytime somnolence in PD, we have conducted multiple single-patient (n-of-1 clinical trials comparing regular espresso coffee to decaffeinated coffee in PD patients presenting moderate to severe daytime somnolence defined as an Epworth Sleepiness Scale (ESS score >9. Each single-patient (n-of-1 trial included a sequence of three crossovers (two treatment periods separated by two days of washout. Four patients were included in the studies and three completed the three pairs of treatment periods. In two of the four patients, espresso coffee was considered beneficial. This study concludes that multiple single patient trials are feasible in PD and suggests that espresso-coffee may have a beneficial effect on daytime somnolence in some patients. These results cannot be generalized beyond the patients included in these trials.

  6. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial

    DEFF Research Database (Denmark)

    Choueiri, Toni K; Escudier, Bernard; Powles, Thomas;

    2016-01-01

    BACKGROUND: Cabozantinib is an oral inhibitor of tyrosine kinases including MET, VEGFR, and AXL. The randomised phase 3 METEOR trial compared the efficacy and safety of cabozantinib versus the mTOR inhibitor everolimus in patients with advanced renal cell carcinoma who progressed after previous...... VEGFR tyrosine-kinase inhibitor treatment. Here, we report the final overall survival results from this study based on an unplanned second interim analysis. METHODS: In this open-label, randomised phase 3 trial, we randomly assigned (1:1) patients aged 18 years and older with advanced or metastatic...

  7. 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.

  8. Bristol Girls Dance Project Feasibility Trial: outcome and process evaluation results

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    Jago Russell

    2012-07-01

    Full Text Available Abstract Background Many adolescent girls do not engage in sufficient physical activity (PA. This study examined the feasibility of conducting a cluster randomized controlled trial (RCT to evaluate an after-school dance program to increase PA among 11–12 year old girls in Bristol, UK. Methods Three-arm, cluster RCT. Three secondary schools were assigned to intervention arm. Intervention participants received a 9-week dance program with 2, 90-minute dance classes per week. Participants at 2 control schools received incentives for data collection. Participants at 2 additional control schools received incentives and a delayed dance workshop. Accelerometer data were collected at baseline (time 0, during the last week of the dance program (time 1 and 20 weeks after the start of the study (time 2. Weekly attendance, enjoyment and perceived exertion were assessed in intervention participants. Post-study qualitative work was conducted with intervention participants and personnel. Results 40.1% of girls provided consent to be in the study. The mean number of girls attending at least one dance session per week ranged from 15.4 to 25.9. There was greater number of participants for whom accelerometer data were collected in control arms. The mean attendance was 13.3 sessions (maximum = 18. Perceived exertion ratings indicated that the girls did not find the sessions challenging. The dance teachers reported that the program content would benefit from revisions including less creative task time, a broader range of dance genres and improved behavioral management policies. At time 2, the 95% confidence intervals suggest between 5 and 12 minutes more weekday MVPA in the intervention group compared with the control incentives only group, and between 6 minutes fewer and 1 minute more compared with the control incentives plus workshop group. Between 14 and 24 schools would be required to detect a difference of 10 minutes in mean weekday MVPA between

  9. 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

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

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    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

  11. 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.

  12. GeoLab in NASA's Pressurized Excursion Module: First Results from the 2010 Field Trials

    Science.gov (United States)

    Evans, Cynthia A.; Calaway, Michael; Bell, Mary Sue; Graff, Trevor

    2010-01-01

    Before humans explore other planets, NASA must develop advanced techniques for collection, preservation and return of unique extraterrestrial samples. To help evaluate hardware requirements and operational concepts for future sample-return missions, we designed and built GeoLab our first generation lab for geological samples into NASA s Habitat Demonstration Unit in the Pressurized Excursion Module (HDU1-PEM). The center of GeoLab is a glovebox for the examination of samples in a shirt-sleeve environment. As part of a deployable habitat, GeoLab can participate in NASA s analog missions that simulate planetary exploration activities and support the testing of relevant technologies for collecting and handling geological samples. Over time, these tests will evaluate sample handling environments (field and lab), sampling tools and analytical instruments, and different scenarios involving both robotic and human procedures. The GeoLab design supports evolving tests and configurations. The glovebox is mounted on the habitat bulkhead, with three sample pass-though chambers that allow for direct sample transfer into the glovebox from the outside. The glovebox design and construction (low-particle shedding, minimally off-gassing materials) provides a clean environment to reduce sample contamination; in the future, we will integrate a positive pressure, enriched nitrogen atmosphere. The glovebox is equipped with configurable instrument ports. The 2010 test included a mass balance, a stereomicroscope with a HD camera for detailed imaging of samples, and a handheld XRF analyzer for preliminary geochemical characterization of samples. Network cameras provided context imagery and sample handling activities. We present early results from the initial field trial of GeoLab during the 2010 Desert Research and Technology Studies (D-RATS) planetary analog test near Flagstaff AZ. The 2010 D-RATS mission involved two rovers, the habitat with GeoLab, four crew members, and a team of

  13. Alirocumab for hyperlipidemia: ODYSSEY Phase III clinical trial results and US FDA approval indications.

    Science.gov (United States)

    Roth, Eli M

    2016-03-01

    A new class of lipid-lowering drugs, inhibitors of PCSK9 has been generating impressive clinical trial data over the last several years, and alirocumab (Praluent) has become the first to be approved by the US FDA. Alirocumab has been shown to lower low density lipoprotein cholesterol by 45-62% with a safety profile generally comparable to placebo. Alirocumab is a monoclonal antibody to PCSK9 administered subcutaneously and has been evaluated in 16 Phase III clinical trials, the majority of which have been enrolled or completed. This article will be a review of the available Phase III safety and efficacy data of the ODYSSEY studies including a brief description of each of the 16 studies.

  14. 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

  15. Laryngeal preservation with induction chemotherapy for hypopharyngeal squamous cell carcinoma : 10-year results of EORTC trial 24891

    NARCIS (Netherlands)

    Lefebvre, J. -L.; Andry, G.; Chevalier, D.; Luboinski, B.; Collette, L.; Traissac, L.; de Raucourt, D.; Langendijk, J. A.

    2012-01-01

    We report the 10-year results of the EORTC trial 24891 comparing a larynx-preservation approach to immediate surgery in hypopharynx and lateral epilarynx squamous cell carcinoma. Two hundred and two patients were randomized to either the surgical approach (total laryngectomy with partial pharyngecto

  16. Subtrochanteric Fractures in Bisphosphonate-Naive Patients: Results from the HORIZON-Recurrent Fracture Trial

    OpenAIRE

    2011-01-01

    Our purpose was to characterize the risks of osteoporosis-related subtrochanteric fractures in bisphosphonate-naive individuals. Baseline characteristics of patients enrolled in the HORIZON-Recurrent Fracture Trial with a study-qualifying hip fracture were examined, comparing those who sustained incident subtrochanteric fractures with those sustaining other hip fractures. Subjects were bisphosphonate-naive or had a bisphosphonate washout period of 6–24 months and subsequently received an annu...

  17. Xyloglucan for the Treatment of Acute Gastroenteritis in Children: Results of a Randomized, Controlled, Clinical Trial

    OpenAIRE

    Cătălin Pleșea Condratovici; Vladimir Bacarea; Núria Piqué

    2016-01-01

    Background. Xyloglucan, a film-forming agent, improves intestinal mucosa resistance to pathologic damage. The efficacy, safety, and time of onset of the antidiarrheal effect of xyloglucan were assessed in children with acute gastroenteritis receiving oral rehydration solution (ORS). Methods. This randomized, controlled, open-label, parallel-group, multicenter, clinical trial included children (3 months–12 years) with acute gastroenteritis of infectious origin. Children were randomized to xylo...

  18. Technical results of Y-12/IAEA field trial of remote monitoring system

    Energy Technology Data Exchange (ETDEWEB)

    Corbell, B.H. [Sandia National Labs., Albuquerque, NM (United States); Whitaker, J.M. [Lockheed Martin Energy Systems, Inc., Oak Ridge, TN (United States); Welch, J. [Aquila Technologies Group, Albuquerque, NM (United States)] [and others

    1997-08-01

    A Remote Monitoring System (RMS) field trial has been conducted with the International Atomic Energy Agency (IAEA) on highly enriched uranium materials in a vault at the Oak Ridge Y-12 Plant. The RMS included a variety of Sandia, Oak Ridge, and Aquila sensor technologies which provide containment seals, video monitoring, radiation asset measurements, and container identification data to the on-site DAS (Data Acquisition System) by way of radio-frequency and Echelon LonWorks networks. The accumulated safeguards information was transmitted to the IAEA via satellite (COMSAT/RSI) and international telephone lines. The technologies tested in the remote monitoring environment are the RadCouple, RadSiP, and SmartShelf sensors from the ORSENS (Oak Ridge Sensors for Enhancing Nuclear Safeguards) technologies; the AIMS (Authenticated Item Monitoring System) motion sensor (AMS), AIMS fiber-optic seal (AFOS), ICAM (Image Compression and Authentication Module) video surveillance system, DAS (Data Acquisition System), and DIRS (Data and Image Review Station) from Sandia; and the AssetLAN identification tag, VACOSS-S seal, and Gemini digital surveillance system from Aquila. The field trial was conducted from October 1996 through May 1997. Tests were conducted during the monthly IAEA Interim Inventory Verification (IIV) inspections for evaluation of the equipment. Experience gained through the field trials will allow the technologies to be applied to various monitoring scenarios.

  19. Thiazolidinediones and cancer: results of a meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Monami, Matteo; Dicembrini, Ilaria; Mannucci, Edoardo

    2014-02-01

    Recent epidemiological data have contributed to the formulation of the hypothesis about the long-term safety of pioglitazone, a thiazolidinedione (TZD), with respect to malignancies, in particular bladder cancer. The primary aim of this meta-analysis of randomized clinical trials, not designed a priori to test this hypothesis, was to explore whether TZDs affect the risk of cancer. A meta-analysis was performed including published and unpublished randomized trials with a duration of at least 52 weeks, enrolling patients with or without diabetes, comparing TZDs with either placebo or other drug therapies on various different outcomes. We found 22 trials reporting at least one cancer and enrolling 13,197 patients to TZD (pioglitazone: n = 3,710 and rosiglitazone: n = 9,487) and 12,359 to placebo or active comparator groups. The mean follow-up was 26.1 months. Overall, those assigned at random to TZDs had a significant reduction (MH-OR 0.85 [0.73-0.98]; p = 0.027) in the incidence of malignancies, with no significant difference in effect between pioglitazone and rosiglitazone. Specifically, subgroup analyses showed a significant reduction for rosiglitazone (MH-OR 0.82 [0.69-0.98]; p = 0.029), but not for pioglitazone (MH-OR 0.66 [0.34-1.28]; p = 0.22). In further subgroup analyses of site-specific malignancies based on the data from four trials, the risk of bladder cancer with pioglitazone (MH-OR) was 2.05 [0.84-5.02]; p = 0.12. Further, rosiglitazone, but not pioglitazone, was associated with a significantly reduced risk of bowel cancer. In contrast, pioglitazone, but not rosiglitazone, was associated with a significant reduction in breast cancer. The present meta-analysis of trials, not designed a priori to test the hypothesis, provides reassuring evidence that TZDs are not associated with risk of overall malignancies. In fact, they are compatible with the possibility of a decreased risk of cancer. In site-specific subgroup analyses, for rosiglitazone, there was a

  20. 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.

  1. 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.

  2. 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

  3. Stock market returns and clinical trial results of investigational compounds: an event study analysis of large biopharmaceutical companies.

    Directory of Open Access Journals (Sweden)

    Thomas J Hwang

    Full Text Available BACKGROUND: For biopharmaceutical companies, investments in research and development are risky, and the results from clinical trials are key inflection points in the process. Few studies have explored how and to what extent the public equity market values clinical trial results. METHODS: Our study dataset matched announcements of clinical trial results for investigational compounds from January 2011 to May 2013 with daily stock market returns of large United States-listed pharmaceutical and biotechnology companies. Event study methodology was used to examine the relationship between clinical research events and changes in stock returns. RESULTS: We identified public announcements for clinical trials of 24 investigational compounds, including 16 (67% positive and 8 (33% negative events. The majority of announcements were for Phase 3 clinical trials (N = 13, 54%, and for oncologic (N = 7, 29% and neurologic (N = 6, 24% indications. The median cumulative abnormal returns on the day of the announcement were 0.8% (95% confidence interval [CI]: -2.3, 13.4%; P = 0.02 for positive events and -2.0% (95% CI: -9.1, 0.7%; P = 0.04 for negative events, with statistically significant differences from zero. In the day immediately following the announcement, firms with positive events were associated with stock price corrections, with median cumulative abnormal returns falling to 0.4% (95% CI: -3.8, 12.3%; P = 0.33. For firms with negative announcements, the median cumulative abnormal returns were -1.7% (95% CI: -9.5, 1.0%; P = 0.03, and remained significantly negative over the two day event window. The magnitude of abnormal returns did not differ statistically by indication, by trial phase, or between biotechnology and pharmaceutical firms. CONCLUSIONS: The release of clinical trial results is an economically significant event and has meaningful effects on market value for large biopharmaceutical companies. Stock return underperformance due to negative events

  4. 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.

  5. Principal results of the Medical Research Council's 8th acute myeloid leukaemia trial.

    Science.gov (United States)

    Rees, J K; Gray, R G; Swirsky, D; Hayhoe, F G

    1986-11-29

    Between 1978 and 1983, 1127 patients with de-novo acute myeloid leukaemia (AML) were entered into the Medical Research Council (MRC)'s 8th AML trial. All received the same induction therapy consisting of daunorubicin, cytarabine, and 6-thioguanine--DAT (1 + 5). The 67% who entered complete remission were randomised to consolidation with two or six further courses of DAT. Adults under the age of 55 were randomised for central nervous system (CNS) prophylaxis with intrathecal cytarabine and methotrexate. Finally, those still in remission after 1 year of cytarabine and 6-thioguanine (AT) maintenance were randomised to receive either late intensification with cyclophosphamide, vincristine, cytarabine, and prednisolone (COAP) or continued AT. The median survival for the whole group was 12 months; the median duration of first remission was 15 months, with relapse-free survival at 5 years estimated at 18%. The factors most strongly associated with poor survival were performance status and age at presentation, but even among those over 60 years of age, half went into remission. Six courses of DAT consolidation gave a small advantage over two courses in reducing the number of late relapses but no significant survival advantage. Late intensification showed a marginally significant advantage over continued AT maintenance. The incidence of CNS relapse was low and unaffected by prophylaxis. The second remission rate varied from 10% when the first remission was shorter than 6 months to 61% when it had continued for more than 2 years. 40 patients received histocompatible allogeneic bone-marrow transplants in first remission. There was a high procedure-related death rate, particularly among patients over 30 years of age. Thus, initially at least, the transplanted group had shorter survival than a comparable group of chemotherapy-treated patients. Treatment specifications remained unchanged throughout the trial but those enrolled in the later half of the trial had a better (p = 0

  6. 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...

  7. Graphic Warning Labels Elicit Affective and Thoughtful Responses from Smokers: Results of a Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Abigail T Evans

    Full Text Available Observational research suggests that placing graphic images on cigarette warning labels can reduce smoking rates, but field studies lack experimental control. Our primary objective was to determine the psychological processes set in motion by naturalistic exposure to graphic vs. text-only warnings in a randomized clinical trial involving exposure to modified cigarette packs over a 4-week period. Theories of graphic-warning impact were tested by examining affect toward smoking, credibility of warning information, risk perceptions, quit intentions, warning label memory, and smoking risk knowledge.Adults who smoked between 5 and 40 cigarettes daily (N = 293; mean age = 33.7, did not have a contra-indicated medical condition, and did not intend to quit were recruited from Philadelphia, PA and Columbus, OH. Smokers were randomly assigned to receive their own brand of cigarettes for four weeks in one of three warning conditions: text only, graphic images plus text, or graphic images with elaborated text.Data from 244 participants who completed the trial were analyzed in structural-equation models. The presence of graphic images (compared to text-only caused more negative affect toward smoking, a process that indirectly influenced risk perceptions and quit intentions (e.g., image->negative affect->risk perception->quit intention. Negative affect from graphic images also enhanced warning credibility including through increased scrutiny of the warnings, a process that also indirectly affected risk perceptions and quit intentions (e.g., image->negative affect->risk scrutiny->warning credibility->risk perception->quit intention. Unexpectedly, elaborated text reduced warning credibility. Finally, graphic warnings increased warning-information recall and indirectly increased smoking-risk knowledge at the end of the trial and one month later.In the first naturalistic clinical trial conducted, graphic warning labels are more effective than text-only warnings

  8. 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...

  9. Family-focused treatment for childhood-onset depressive disorders: results of an open trial.

    Science.gov (United States)

    Tompson, Martha C; Pierre, Claudette B; Haber, Fawn McNeil; Fogler, Jason M; Groff, April R; Asarnow, Joan R

    2007-07-01

    Study objectives were to develop a treatment manual for a family-focused intervention for depressed school-aged children, evaluate its feasibility and acceptability, and complete an initial open trial to examine treatment effects. Nine young people meeting criteria for depression (major depressive disorder, dysthymic disorder, or depression not otherwise specified), completed a 12-week family intervention, and were assessed immediately and at 9 months following treatment completion. The intervention presented an interpersonal model of how depressive symptoms are maintained, and emphasized developing family strategies for altering interpersonal processes, supporting recovery and enhancing resilience. At posttreatment 66% of the young people had recovered from their depressive episodes; by 9 months posttreatment 77% had recovered. Significant improvements in global functioning were noted. There were no relapses in the follow-up period and no instances of suicidal behavior during the intervention or follow-up. Mothers' and fathers' Child Behavior Checklist reports and children's self reports indicated significant symptom reductions. Exploratory analyses suggest particular benefit for young people with parents high in criticism. The family-focused intervention for childhood-onset depression demonstrated gains similar to those seen with empirically supported treatments for depressed adolescents and superior to those seen in naturalistic studies of depression outcomes. This favorable risk/benefit profile supports the value of a randomized controlled trial.

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

    Science.gov (United States)

    Proietti, Riccardo; Joza, Jacqueline; Arensi, Andrea; Levi, Michael; Russo, Vincenzo; Tzikas, Apostolos; Danna, Paolo; Sagone, Antonio; Viecca, Maurizio; Essebag, Vidal

    2015-01-01

    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 available technologies for percutaneous LAA closure, as well as a summary of the published trials concerning their safety and efficacy in reducing stroke risk in AF. PMID:25678828

  11. 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.

  12. 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.

  13. 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

  14. Celecoxib to prevent restenosis--results from the COREA-TAXUS trial.

    Science.gov (United States)

    Doggrell, Sheila A

    2008-02-01

    Celecoxib inhibits Akt, which is stimulated during restenosis. Cell and animal studies showed that celecoxib inhibited Akt stimulation and restenosis. Recently, the COREA-TAXUS (Effect of Celecoxib on Restenosis after Coronary Angioplasty with Taxus stent) trial was performed in subjects with angina or a positive-stress test receiving paclitaxel-eluting stents. The primary end point at 6 months was the in-stent, late luminal loss, which was 0.49 mm in the celecoxib-treated group; less than the 0.75 mm in the group not treated with celecoxib. The rate of revascularisation of the target lesion was lower in celecoxib-treated subjects (5%) than in the untreated subjects (15%). In conclusion, this is an excellent demonstration of translating a mechanism of action of a drug into a clinical use.

  15. 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.

  16. Effects of serotonin reuptake inhibitors on aggressive behavior in psychiatrically hospitalized adolescents: results of an open trial.

    Science.gov (United States)

    Constantino, J N; Liberman, M; Kincaid, M

    1997-01-01

    Low concentrations of the neurotransmitter serotonin and its 5-hydroxyindoleacetic acid metabolite in the central nervous system have been associated with increased aggressive behavior in animals and humans. Controlled clinical trials of serotonin agonists in depressed adults have suggested that aggressive behavior is less likely during treatment with these medications than with placebo, but there have been no previous studies of selective serotonin reuptake inhibitors (SSRIs) and aggression in children. We prospectively followed the course of aggressive behavior in 19 psychiatrically hospitalized adolescents (not selected for aggressiveness) who received open clinical trials of fluoxetine, paroxetine, or sertraline. The patients received standard doses (equivalent to fluoxetine 10-40 mg daily) for a minimum of 5 weeks. The starting dose was 15 +/- 5 mg, and dosages were raised at a mean rate of 5 mg every 4 days up to a mean dose of 25 +/- 10 mg daily. Results from trials of the three SSRIs were clustered because the sample sizes were not sufficient for separate analyses. Overall, there were no statistically meaningful improvements in the level of aggressive behavior, as measured on a modified version of the Overt Aggression Scale, over the course of these patients' SSRI trials. Symptoms of physical aggression toward others or self were manifest in 12 of the 19 patients while on SSRIs. Of the 19 patients, 13 were assessed both on and off SSRIs: verbal aggression (p = 0.04), physical aggression toward objects (p = 0.05), and physical aggression toward self (p < 0.02) occurred significantly more frequently on SSRIs than off; no increase was observed in physical aggression toward others. Patients with the highest baseline aggressivity scores did not show greater improvement during SSRI treatment. Further research is warranted, particularly to explore whether SSRIs may have therapeutic effects on aggression at higher (or lower) doses than were administered in this

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

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    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

  18. Cost-effectiveness of compression technologies for evidence-informed leg ulcer care: results from the Canadian Bandaging Trial

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    Pham Ba'

    2012-10-01

    Full Text Available Abstract Background Venous leg ulcers, affecting approximately 1% of the population, are costly to manage due to poor healing and high recurrence rates. We evaluated an evidence-informed leg ulcer care protocol with two frequently used high compression systems: ‘four-layer bandage’ (4LB and ‘short-stretch bandage’ (SSB. Methods We conducted a cost-effectiveness analysis using individual patient data from the Canadian Bandaging Trial, a publicly funded, pragmatic, randomized trial evaluating high compression therapy with 4LB (n = 215 and SSB (n = 209 for community care of venous leg ulcers. We estimated costs (in 2009–2010 Canadian dollars from the societal perspective and used a time horizon corresponding to each trial participant’s first year. Results Relative to SSB, 4LB was associated with an average 15 ulcer-free days gained, although the 95% confidence interval [−32, 21 days] crossed zero, indicating no treatment difference; an average health benefit of 0.009 QALYs gained [−0.019, 0.037] and overall, an average cost increase of $420 [$235, $739] (due to twice as many 4LB bandages used; or equivalently, a cost of $46,667 per QALY gained. If decision makers are willing to pay from $50,000 to $100,000 per QALY, the probability of 4LB being more cost effective increased from 51% to 63%. Conclusions Our findings differ from the emerging clinical and economic evidence that supports high compression therapy with 4LB, and therefore suggest another perspective on high compression practice, namely when delivered by trained registered nurses using an evidence-informed protocol, both 4LB and SSB systems offer comparable effectiveness and value for money. Trial registration ClinicalTrials.gov Identifier: NCT00202267

  19. "To whom do the results of this trial apply?" External validity of a randomized controlled trial involving 130 patients scheduled for primary total hip replacement

    DEFF Research Database (Denmark)

    Petersen, Mette K; Andersen, Karen Vestergaard; Andersen, Niels T

    2007-01-01

    , but they should at least allow patients and clinicians to judge to whom trial results can reasonably be applied. We assessed the external validity of an RCT investigating the efficacy of a fast-track program after total hip replacement. METHODS: 130 patients were identified as potential participants.18 patients...... were excluded, 33 enrolled patients declined to participate, and 79 patients were enrolled and randomized. We studied the distribution of preoperative characteristics and postoperative clinical variables in these 3 groups. RESULTS: A significant difference was found in both preoperative characteristics...... and clinical outcome variables. The non-consenters were older, less healthy, and needed more help from the home care system. Furthermore, they were hospitalized longer and were more often transferred to a rehabilitation ward. INTERPRETATION: Our findings demonstrate the importance of patient inclusion criteria...

  20. 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

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

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    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.)

  2. 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.

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

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    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.

  4. 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

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

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    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

  6. Antidepressant action of sulpiride. Results of a placebo-controlled double-blind trial.

    Science.gov (United States)

    Rüther, E; Degner, D; Munzel, U; Brunner, E; Lenhard, G; Biehl, J; Vögtle-Junkert, U

    1999-07-01

    The purpose of this multicenter, randomized, double-blind, placebo-controlled parallel-group comparative study was to prove the efficacy and tolerance of sulpiride (150-300 mg) against placebo in mild to moderate depressive syndrome. The primary criterion of efficacy was the course of the HAMD total score from day 1 to day 42, compared between the two treatment groups. The duration of the treatment was six weeks, preceded by a one-week placebo run-in phase. The HAMD, CGI and KUSTA scores were determined, the tolerance assessed, and the laboratory parameters and serum prolactin levels determined before, during and at the end of the trial. 177 outpatients aged from 18 to 70 years with mild to moderate depressive syndrome (ICD-10: F32.0, F32.1, F33.0, F33.1) and a score of 18-27 points on the 21-item HAMD scale were randomized, 171 of whom (sulpiride: n=83; placebo: n=88) were included in the intention-to-treat analysis. All the baseline data recorded for the two groups displayed comparable values. The decrease of the HAMD score between day 1 and day 42 yielded a difference of 2.5 points in favour of the sulpiride group. This difference is statistically significant (p = 0.0007). The evaluations of the cases treated for at least 14 days or for 42 days (per protocol) showed consistent values. The analysis of the CGI values showed similarly distinct and clinically relevant differences for sulpiride in comparison with placebo. The evaluation of the KUSTA scores yielded mostly comparable values for the two groups. Adverse events occurred with about the same type and frequency in both groups, with severe adverse events occurring only in two placebo patients. The laboratory parameters revealed no significant differences between the treatment groups, with the exception of prolactin which moderately exceeded the range of normal in 50% of the patients treated with sulpiride. This trial proved that sulpiride is effective and well-tolerated when given in a mean dose of 181 mg per

  7. Phosphorous acid residues in apples after foliar fertilization: results of field trials.

    Science.gov (United States)

    Malusà, E; Tosi, L

    2005-06-01

    The levels of phosphorous acid residues in apples after foliar fertilization with P fertilizers and after treatment with a phosphonate fungicide (Fosetyl-Al) were determined and compared. Two field trials and a glasshouse experiment, using different genotypes and plants of different age, were carried out and monitored over a three-year period. Phosphorous acid residues were found in apples after application of foliar P fertilizers. Concentrations of the residues ranged between 0.02 and 14 mg kg(-1) depending on the phosphorous acid content in the fertilizer used and the plant size and yield. The treatments induced an accumulation of the residue in the course of the experiments, which in some cases reached a level exceeding the maximum limit set by EU legislation. Residues were also detected in other plant organs, i.e., roots and buds. Plants treated with Fosetyl-Al contained phosphorous acid residues in their fruits and buds two years after the suspension of the treatment, suggesting a long-term persistence of the substance in plant storage organs. A second experiment, involving treatment of trees with seven foliar fertilizers of different composition, also induced accumulation of phosphorous acid residues in fruits. It is concluded that a wide array of foliar products containing phosphorous acid, even as a minor component, could mimic the residue effect of phosphonate fungicide treatments.

  8. 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.

  9. 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.

  10. Metformin in Amnestic Mild Cognitive Impairment: Results of a Pilot Randomized Placebo Controlled Clinical Trial.

    Science.gov (United States)

    Luchsinger, José A; Perez, Thania; Chang, Helena; Mehta, Pankaj; Steffener, Jason; Pradabhan, Gnanavalli; Ichise, Masanori; Manly, Jennifer; Devanand, Davangere P; Bagiella, Emilia

    2016-01-01

    Diabetes and hyperinsulinemia may be risk factors for Alzheimer's disease (AD). We conducted a pilot study of metformin, a medication efficacious in treating and preventing diabetes while reducing hyperinsulinemia, among persons with amnestic mild cognitive impairment (aMCI) with the goal of collecting preliminary data on feasibility, safety, and efficacy. Participants were 80 men and women aged 55 to 90 years with aMCI, overweight or obese, without treated diabetes. We randomized participants to metformin 1000 mg twice a day or matching placebo for 12 months. The co-primary clinical outcomes were changes from baseline to 12 months in total recall of the Selective Reminding Test (SRT) and the score of the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). The secondary outcome was change in relative glucose uptake in the posterior cingulate-precuneus in brain fluorodeoxyglucose positron emission tomography. Change in plasma Aβ42 was an exploratory outcome. The mean age of participants was 65 years. Fifty percent of participants were women. The only baseline variable that was different between the arms was the ADAS-Cog. Metformin could not be tolerated by 7.5% of participants; 15% tolerated 500 mg/day, 35% tolerated 1000 mg/day, 32.5% tolerated 1500 mg/day, and only 10% tolerated the maximum dose. There were no serious adverse events related to metformin. The 7.5% of persons who did not tolerate metformin reported gastrointestinal symptoms. After adjusting for baseline ADAS-cog, changes in total recall of the SRT favored the metformin group (9.7±8.5 versus 5.3±8.5; p = 0.02). Differences for other outcomes were not significant. A larger trial seems warranted to evaluate the efficacy and cognitive safety of metformin in prodromal AD.

  11. Subtrochanteric fractures in bisphosphonate-naive patients: results from the HORIZON-recurrent fracture trial.

    Science.gov (United States)

    Adachi, Jonathan D; Lyles, Kenneth; Boonen, Steven; Colón-Emeric, Cathleen; Hyldstrup, Lars; Nordsletten, Lars; Pieper, Carl; Recknor, Chris; Su, Guoqin; Bucci-Rechtweg, Christina; Magaziner, Jay

    2011-12-01

    Our purpose was to characterize the risks of osteoporosis-related subtrochanteric fractures in bisphosphonate-naive individuals. Baseline characteristics of patients enrolled in the HORIZON-Recurrent Fracture Trial with a study-qualifying hip fracture were examined, comparing those who sustained incident subtrochanteric fractures with those sustaining other hip fractures. Subjects were bisphosphonate-naive or had a bisphosphonate washout period of 6-24 months and subsequently received an annual infusion of zoledronic acid 5 mg or placebo after low-trauma hip-fracture repair. In total, 2,127 men and women were included. Of the qualifying hip fractures, 5.2% were subtrochanteric, 54.8% femoral neck, 33.0% intertrochanteric, and 7.1% other (generally complex fractures of mixed type). Significant baseline (pre-hip fracture) differences were seen between index hip-fracture types, with the percentage of patients with extreme mobility problems being twofold higher in patients with index subtrochanteric fracture (9.9%) compared to other patients. The distribution of hip-fracture types was similar between the treatment groups at baseline. No patients with index subtrochanteric fractures and six patients with other qualifying hip fractures reported prior bisphosphonate use. Only one further subtrochanteric fracture occurred in each treatment group over an average 2-year patient follow-up. Subtrochanteric fractures are not uncommon in bisphosphonate-naive patients. Extreme difficulties with mobility may be a unique risk factor predisposing to development of incident subtrochanteric fractures rather than other types of hip fracture. In patients with recent hip fracture who received zoledronic acid therapy, the incidence of new subtrochanteric fractures was too small to draw any meaningful conclusions.

  12. Dexamethasone therapy for bacterial meningitis. Results of two double-blind, placebo-controlled trials.

    Science.gov (United States)

    Lebel, M H; Freij, B J; Syrogiannopoulos, G A; Chrane, D F; Hoyt, M J; Stewart, S M; Kennard, B D; Olsen, K D; McCracken, G H

    1988-10-13

    We enrolled 200 infants and older children with bacterial meningitis in two prospective double-blind, placebo-controlled trials to evaluate the efficacy of dexamethasone therapy in addition to either cefuroxime (Study 1) or ceftriaxone (Study 2). Altogether, 98 patients received placebo and 102 received dexamethasone (0.15 mg per kilogram of body weight every six hours for four days). At the beginning of therapy, the clinical and demographic characteristics of the patients in the treatment groups were comparable. The mean increase in the cerebrospinal fluid concentration of glucose and the decreases in lactate and protein levels after 24 hours of therapy were significantly greater in those who received dexamethasone than in those who received placebo (glucose, 2.0 vs. 0.4 mmol per liter [36.0 vs. 6.9 mg per deciliter], P less than 0.001; lactate, 4.0 vs. 2.1 mmol per liter [38.3 vs. 19.8 mg per deciliter], P less than 0.001; and protein, 0.64 vs. 0.25 g per liter [64.0 vs. 25.3 mg per deciliter], P less than 0.05). One patient in the placebo group in Study 1 died. As compared with those who received placebo, the patients who received dexamethasone became afebrile earlier (1.6 vs. 5.0 days; P less than 0.001) and were less likely to acquire moderate or more severe bilateral sensorineural hearing loss (15.5 vs. 3.3 percent; P less than 0.01). Twelve patients in the two placebo groups (14 percent) had severe or profound bilateral hearing loss requiring the use of a hearing aid, as compared with 1 (1 percent) in the two dexamethasone groups (P less than 0.001). We conclude that dexamethasone is beneficial in the treatment of infants and children with bacterial meningitis, particularly in preventing deafness.

  13. 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.

  14. Antimyosin imaging in acute transmural myocardial infarctions: results of a multicenter clinical trial

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, L.L.; Seldin, D.W.; Becker, L.C.; LaFrance, N.D.; Liberman, H.A.; James, C.; Mattis, J.A.; Dean, R.T.; Brown, J.; Reiter, A.

    1989-01-01

    Murine monoclonal antimyosin antibody has been shown experimentally to bind selectively to irreversibly damaged myocytes. To evaluate the safety and efficacy of monoclonal antimyosin for identifying acute transmural infarction, 50 patients with acute Q wave myocardial infarction were entered into a phase I/II multicenter trial involving three clinical sites. Indium-111 antimyosin was prepared from an instant kit formulation containing 0.5 mg of diethylene triamine pentaacetic acid (DTPA)-coupled Fab fragment (R11D10) and 1.2 to 2.4 mCi of indium-111. Average labeling efficiency was 92%. Antimyosin was injected 27 +/- 16 h after the onset of chest pain. Planar or tomographic imaging was performed 27 +/- 9 h after injection in all patients, and repeat imaging was done 24 h later in 39 patients. Of the 50 patients entered, 46 showed myocardial uptake of antimyosin (sensitivity 92%). Thirty-one of 39 planar scans performed at 24 h were diagnostic; 8 showed persistent blood pool activity that cleared by 48 h. Focal myocardial uptake of antimyosin corresponded to electrocardiographic infarct localization. No patient had an adverse reaction to antimyosin. In addition, 125 serum samples, including 21 collected greater than 42 days after injection, were tested for human antimouse antibodies, and all samples were assessed as having undetectable titers. Intensity of antimyosin uptake was correlated with infarct location and the presence or absence of collateral vessels. There was a significant correlation between faint uptake and inferoposterior infarct location. In 21 patients who had coronary angiography close to the time of antimyosin injection, there was a significant correlation between faint tracer uptake and closed infarct-related vessel with absent collateral flow.

  15. Results of Continuous Load Cell Monitoring Field Trial for UF6 Withdrawals at an Operating Industrial Plant

    Energy Technology Data Exchange (ETDEWEB)

    Krichinsky, Alan M [ORNL; Bell, Lisa S [ORNL; Conchewski, Curtis A [ORNL; Peters, Benjamin R [ORNL; Pickett, Chris A [ORNL; Richardson, Dave [ORNL; Rowe, Nathan C [ORNL; Younkin, James R [ORNL

    2010-01-01

    Continuous load cell monitoring (CLCM) has been implemented and tested for use as a safeguards tool during a 2009 field trial in an operating UF6 transfer facility. The transfer facility is part of the Portsmouth Gaseous Diffusion Plant in Piketon, Ohio, operated by the United States Enrichment Corporation. During the field trial, two process scales for UF{sub 6} cylinders were continuously monitored for a 6-month period as cylinders were being filled. The collected CLCM data were used in testing an event processor serving as a filter for highlighting measurements representing significant operational activities that are important in verifying declared operations. The collection of CLCM data, coupled with rules-based event processing, can provide inspectors with knowledge of a facility's feed and withdrawal activities occurring between site visits. Such process knowledge promises to enhance the effectiveness of safeguards by enabling inspectors to quantitatively compare declared activities directly with process measurements. Selected results of the field trial and event processing will be presented in the context of their value to an independent inspector and a facility operator.

  16. Evaluating results from the multiple myeloma patient subset treated with denosumab or zoledronic acid in a randomized phase 3 trial.

    Science.gov (United States)

    Raje, N; Vadhan-Raj, S; Willenbacher, W; Terpos, E; Hungria, V; Spencer, A; Alexeeva, Y; Facon, T; Stewart, A K; Feng, A; Braun, A; Balakumaran, A; Roodman, G D

    2016-01-08

    In a phase 3 trial of denosumab vs zoledronic acid in patients (n=1776) with bone metastases and solid tumors or multiple myeloma, denosumab was superior to zoledronic acid for the primary end point of prevention of skeletal-related events. There was no difference in overall survival between the two groups; however, an ad hoc overall survival analysis in the multiple myeloma subset of patients (n=180) favored zoledronic acid (hazard ratio (HR) 2.26; 95% confidence interval (CI) 1.13-4.50; P=0.014). In the present analysis, we found imbalances between the groups with respect to baseline risk characteristics. HRs with two-sided 95% CIs were estimated using the Cox model. After adjustment in a covariate analysis, the CI crossed unity (HR 1.86; 95% CI 0.90-3.84; P=0.0954). Furthermore, we found a higher rate of early withdrawals for the reasons of lost to follow-up and withdrawal of consent in the zoledronic acid group; after accounting for these, the HR was 1.31 (95% CI 0.80-2.15; P=0.278). In conclusion, the survival results in multiple myeloma patients in this trial were confounded and will eventually be resolved by an ongoing phase 3 trial.

  17. [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.

  18. Positive outcomes influence the rate and time to publication, but not the impact factor of publications of clinical trial results.

    Directory of Open Access Journals (Sweden)

    Pilar Suñé

    Full Text Available 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. Published articles were identified by searching Pubmed and other electronic databases. Clinical study final reports submitted to the ethics committee, final reports synopses available online and meeting abstracts were also considered as sources of study results. Study outcomes were classified as positive (when statistical significance favoring experimental drug was achieved, negative (when no statistical significance was achieved or it favored control drug and descriptive (for non-controlled studies. Time to publication was defined as time from study closure to publication. A survival analysis was performed using a Cox regression model to analyze time to publication. Journal impact factors of identified publications were recorded. Publication rate was 48·4% (380/785. Study results were identified for 68·9% of all completed clinical trials (541/785. Publication rate was 84·9% (180/212 for studies with results classified as positive and 68·9% (128/186 for studies with results classified as negative (p<0·001. Median time to publication was 2·09 years (IC95 1·61-2·56 for studies with results classified as positive and 3·21 years (IC95 2·69-3·70 for studies with results classified as negative (hazard ratio 1·99 (IC95 1·55-2·55. No differences were found in publication impact factor between positive (median 6·308, interquartile range: 3·141-28·409 and negative result studies (median 8·266, interquartile range: 4·135-17·157. CONCLUSIONS

  19. The Breast International Group 1-98 trial: big results for women with hormone-sensitive early breast cancer.

    Science.gov (United States)

    Monnier, Alain M

    2007-05-01

    As there is a risk for relapse in early breast cancer, especially at 1-3 years post surgery, the need for adjuvant therapy is clear. In terms of disease-free survival, aromatase inhibitors have emerged as superior to tamoxifen for the adjuvant treatment of hormone-sensitive breast cancer in several Phase III clinical trials. Of these trials, the Breast International Group (BIG) 1-98 trial stands out as unique in design, as it is the only trial to address whether an aromatase inhibitor is more effective as initial adjuvant therapy or as sequential therapy with an aromatase inhibitor and tamoxifen in either order and in rigor of end points and safety evaluations. When compared with tamoxifen, letrozole has been shown to significantly reduce recurrence risk in the overall population by 19% and also significantly reduced recurrence risk in the patient subgroups at increased risk: node-positive and previously chemotherapy-treated patients. Letrozole is the only aromatase inhibitor to demonstrate a significant 27% reduction in the risk of distant metastases (p = 0.001) in the clinically relevant, hormone receptor-positive population in the initial adjuvant setting. Recent results also suggest that letrozole in particular reduces the risk of distant metastases early on after initial surgery for breast cancer. This is important, as early distant metastatic events compose the majority of early recurrences and are a well-recognized predictor of breast cancer death. Letrozole has been found to be well tolerated in the initial adjuvant treatment setting, and these data have been confirmed by long-term safety data from the monotherapy analysis in the BIG 1-98 study. Thus far, the results from the BIG 1-98 trial provide clear support for the use of letrozole in the initial adjuvant treatment of breast cancer. Future studies will provide the definitive answer to questions of which initial adjuvant therapy is superior (i.e., anastrozole or letrozole) and information as to the

  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. Epilation for minor trachomatous trichiasis: four-year results of a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Esmael Habtamu

    2015-03-01

    Full Text Available Trachomatous trichiasis (TT needs to be managed to reduce the risk of vision loss. The long-term impact of epilation (a common traditional practice of repeated plucking of lashes touching the eye in preventing visual impairment and corneal opacity from TT is unknown. We conducted a randomized controlled trial of epilation versus surgery for the management of minor TT (fewer than six lashes touching the eye in Ethiopia. Here we report the four-year outcome and the effect on vision and corneal opacity.1300 individuals with minor TT were recruited and randomly assigned to quality trichiasis surgery or repeated epilation using high quality epilation forceps by a trained person with good near vision. Participants were examined six-monthly for two-years, and then at four-years after randomisation. At two-years all epilation arm participants were offered free surgery. At four-years 1151 (88.5% were re-examined: 572 (88% and 579 (89% from epilation and surgery arms, respectively. At that time, 21.1% of the surgery arm participants had recurrent TT; 189/572 (33% of the epilation arm had received surgery, while 383 (67% declined surgery and had continued epilating ("epilation-only". Among the epilation-only group, 207 (54.1% fully controlled their TT, 166 (43.3% had minor TT and 10 (2.6% had major TT (>5 lashes. There were no differences between participants in the epilation-only, epilation-to-surgery and surgery arm participants in changes in visual acuity and corneal opacity between baseline and four-years.Most minor TT participants randomised to the epilation arm continued epilating and controlled their TT. Change in vision and corneal opacity was comparable between surgery and epilation-only participants. This suggests that good quality epilation with regular follow-up is a reasonable second-line alternative to surgery for minor TT for individuals who either decline surgery or do not have immediate access to surgical treatment.

  3. Navigating the clinical trial pathway: Conception, design, execution, and results dissemination.

    Science.gov (United States)

    Sampalis, John S; Watson, Joanne; Boukas, Stella; Boukas, Marianna; Harvey, Natalie; Machado, Sanjay; Bordeleau, Michel; Rampakakis, Emmanouil

    2017-03-01

    Dr Sampalis is founder, Chief Executive Officer, and Chief Scientific Officer of JSS Medical Research Inc, founded in 1997. He is a tenured professor of Surgery and Epidemiology & Biostatistics of McGill University, the University of Montreal and University of Laval. Recognized as a leading clinical epidemiologist and one of the top trauma researchers in Canada, he possesses extensive expertise in health services research, clinical trials, and offers services as a Research and Epidemiological Consultant for numerous pharmaceutical companies, hospitals and government organizations and agencies. Mrs. Watson holds a M.Sc. in Pharmacology from Dalhousie University, and a B.Sc. from the University of Western Ontario. Her experience extends to all facets of the CRO business, and multiple therapeutic areas. She co-founded, in 1992, Integrated Research Inc, a full-service contract research organization, and served as its President and Chief Executive Officer, until merging with JSS Medical Research Inc in 2014. Mrs. Watson currently holds the position of Chief Business Officer, and is head of the business development team. Mrs. Boukas has been working with the JSS Medical Research team since its inception in the 1990s. She holds a B.A. in Psychology from McGill University with training in Epidemiology and Biostatistics, and is certified by the Society of Clinical Research Associates (SOCRA) as a Certified Clinical Research Professional (CCRP). She has over 25 years' of experience in medical research management. Currently Chief Operations Officer, Mrs. Boukas has been essential in structuring and implementing programs at JSS Medical Research Inc to facilitate project management, site recruitment, data capture and study tracking. Mrs. Boukas holds a B.A. from McGill University, a Certificate in Technical Communications from Concordia University and has received compliance training from SNC Lavalin Pharma (SLP) and SOCRA. She has over twenty-five years' experience in

  4. Mortality and morbidity during and after Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial: results by sex.

    Science.gov (United States)

    Oparil, Suzanne; Davis, Barry R; Cushman, William C; Ford, Charles E; Furberg, Curt D; Habib, Gabriel B; Haywood, L Julian; Margolis, Karen; Probstfield, Jeffrey L; Whelton, Paul K; Wright, Jackson T

    2013-05-01

    To determine whether an angiotensin-converting enzyme inhibitor (lisinopril) or calcium channel blocker (amlodipine) is superior to a diuretic (chlorthalidone) in reducing cardiovascular disease incidence in sex subgroups, we carried out a prespecified subgroup analysis of 15 638 women and 17 719 men in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Total follow-up (active treatment + passive surveillance using national administrative databases to ascertain deaths and hospitalizations) was 8 to 13 years. The primary outcome was fatal coronary heart disease or nonfatal myocardial infarction. Secondary outcomes included all-cause mortality, stroke, combined cardiovascular disease (coronary heart disease death, nonfatal myocardial infarction, stroke, angina, coronary revascularization, heart failure [HF], or peripheral vascular disease), and end-stage renal disease. In-trial rates of HF, stroke, and combined cardiovascular disease were significantly higher for lisinopril compared with chlorthalidone, and rates of HF were significantly higher for amlodipine compared with chlorthalidone in both men and women. There were no significant treatment sex interactions. These findings did not persist through the extension period with the exception of the HF result for amlodipine versus chlorthalidone, which did not differ significantly by sex. For both women and men, rates were not lower in the amlodipine or lisinopril groups than in the chlorthalidone group for either the primary coronary heart disease outcome or any other cardiovascular disease outcome, and chlorthalidone-based treatment resulted in the lowest risk of HF. Neither lisinopril nor amlodipine is superior to chlorthalidone for initial treatment of hypertension in either women or men. Clinical Trial Registration- clinicaltrials.gov; Identifier: NCT00000542.

  5. 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

  6. 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

  7. 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...

  8. Effects of a Smokers' Hotline: Results of a 10-County Self-Help Trial.

    Science.gov (United States)

    Ossip-Klein, Deborah J.; And Others

    1991-01-01

    Evaluated effect of smokers' hotline as adjunct to self-help manuals. Subjects (n=1,813), assigned to manual only or manual plus hotline condition, were followed over 18 months. Results showed consistent, significant hotline effect across outcome measures and follow-up periods. Findings suggest effectiveness of hotline in enhancing self-help quit…

  9. Improving the Management Style of School Principals: Results from a Randomized Trial

    Science.gov (United States)

    Lassibille, Gérard

    2016-01-01

    Using information from a randomized experiment carried out over the course of two school years in Madagascar, this paper evaluates the impact of specific actions designed to streamline and tighten the work processes of public primary school directors. The results show that interventions at the school level, reinforced by interventions at the…

  10. 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…

  11. The cost-effectiveness of point of care testing in a general practice setting: results from a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Briggs Nancy E

    2010-06-01

    Full Text Available Abstract Background While point of care testing (PoCT for general practitioners is becoming increasingly popular, few studies have investigated whether it represents value for money. This study aims to assess the relative cost-effectiveness of PoCT in general practice (GP compared to usual testing practice through a pathology laboratory. Methods A cost-effectiveness analysis based on a randomized controlled trial with 4,968 patients followed up for 18 months and fifty-three general practices in urban, rural and remote locations across three states in Australia. The incremental costs and health outcomes associated with a clinical strategy of PoCT for INR, HbA1c, lipids, and ACR were compared to those from pathology laboratory testing. Costs were expressed in year 2006 Australian dollars. Non-parametric bootstrapping was used to generate 95% confidence intervals. Results The point estimate of the total direct costs per patient to the health care sector for PoCT was less for ACR than for pathology laboratory testing, but greater for INR, HbA1c and Lipids, although none of these differences was statistically significant. PoCT led to significant cost savings to patients and their families. When uncertainty around the point estimates was taken into account, the incremental cost-effectiveness ratio (ICER for PoCT was found to be unfavourable for INR, but somewhat favourable for ACR, while substantial uncertainty still surrounds PoCT for HbA1c and Lipids. Conclusions The decision whether to fund PoCT will depend on the price society is willing to pay for achievement of the non-standard intermediate outcome indicator. Trial registration Australian New Zealand Clinical Trial Registry ACTRN12605000272695

  12. Treatment results of three consecutive German childhood AML trials: BFM-78, -83, and -87. AML-BFM-Group.

    Science.gov (United States)

    Ritter, J; Creutzig, U; Schellong, G

    1992-01-01

    Acute myelogenous leukemia (AML) represents a heterogenous group of leukemias in adults as well as in children. The BFM group initiated 3 consecutive studies on the treatment of this disease. Between December 1978 and April 1991, 543 children under the age of 17 years entered the 3 consecutive multicenter studies, AML-BFM-78 (n = 151), AML-BFM-83 (n = 182), and the still ongoing study AML-BFM-87 (n = 210). The treatment strategy of BFM-78 consisted of an eight week induction/-consolidation regimen employing 7 different drugs together with cranial irradiation, followed by continuous maintenance for two years. The main alteration in the second study BFM-83 was the addition of an intensive 8-day ADE induction course (cytosine arabinoside, daunorubicin, etoposide). In the ongoing trial BFM-87 two courses of HD-ARA-C and etoposide are given after consolidation. CR rates were 80% in trials I and II, and 78% in trial III. The probability of a 4.5-year event-free survival was 35%, SD 4% in study I; 49%, SD 4% in study II, and 45%, SD 4% in study III. The probability of a 4.5-year event-free interval (EFI) was increased from 45%, SD 5% in study I to 61%, SD 4% in study II, it is in the same range in study III (58%, SD 5%). Seven of 10 children which underwent bone marrow transplantation (BMT) in 1. CR are still in first CR after a maximum follow-up time of 3.5 yrs. In summary, the addition of HD-ARA-C together with etoposide given after induction/consolidation treatment did not further reduce the incidence of relapses in childhood AML. So far, the results of study BFM-87 are in the same range than those of study BFM-83.

  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.

  14. A field-trial of two restorative materials used with atraumatic restorative treatment in rural Turkey: 24-month results

    Directory of Open Access Journals (Sweden)

    Ertugrul Ercan

    2009-08-01

    Full Text Available OBJECTIVE: The purpose of this study was to investigate the clinical performance of high-strength glass ionomer cement (HSGIC and resin-modified glass ionomer (RMGIC in single and multiple surface carious cavities in the field conditions. MATERIAL AND METHODS: A split-mouth design, including ninety-one fillings placed on contra lateral molar pairs of 37 children, was used in permanent dentition. As filling materials, a HSGIC (Ketac Molar/3M ESPE and a RMGIC (Vitremer/ 3M ESPE were used with the Atraumatic Restorative Treatment (ART. Baseline and 6, 12 and 24-month evaluations of the fillings were made with standard-ART and USPHS criteria by two examiners with kappa values of 0.92 and 0.87 for both criteria. RESULTS: According to the USPHS criteria, the retention rates of RMGIC and HSGIC restorations were 100% and 80.9% for single surface, and 100% and 41.2% for multiple surface restorations after 24 months, respectively. Irrespective of surface number, RMGIC was significantly superior to HSGIC (p= 0.004, according to both standard-ART and USPHS criteria. CONCLUSION: The results indicate that RMGIC may be an alternative restorative technique in comparison to high-strength GIC applications in ART-field-trials. However, further clinical and field trials are needed to support this conclusion.

  15. 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.

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

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    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.

  17. 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.

  18. Cocaine phenomenology study: results of a third in a series of field trials

    Science.gov (United States)

    Su, Chih-Wu; Rigdon, Stephen W.; Ricard, Steve; Hoglund, David E.; Drolet, Gerry; Neudorfl, Pavel; Hupe, Michael; Kunz, Terry D.; Ulvick, Sydney J.; Demirgian, Jack C.; Shier, Patrick; Wingo, Jeff J.

    1997-01-01

    To form an understanding of the environment in which non- intrusive detection and inspection technologies are required to operate, the Narcotic Detection Technology assessment Team has undertaken a series of field studies. These field studies have focused on the phenomenology, fate and behavior of narcotic residue in real world environments. The overall goal of the tests is to give Law Enforcement officers the ability to accurately differentiate between individuals involved in the smuggling process and individuals innocently contaminated with narcotics. The latest filed study in this series was conducted in Miami, FL in February 1996. The field study comprised several individual tests. The first was a contamination and transfer study which focuses on human contamination resulting from contact with actual kilos of cocaine and the mechanism by which this contamination transfers to surrounding objects, if at all. The second was a secondary contamination study which focused on determining the conditions under which cocaine contamination transfers from objects touched by individuals who handled narcotics to innocent passerbys. The third was a persistence study which focused on the persistence of cocaine contamination on people under a variety of conditions. An overview of the tests and their preliminary results will be discussed.

  19. Use of antipsychotics and benzodiazepines in patients with psychiatric emergencies: Results of an observational trial

    Directory of Open Access Journals (Sweden)

    Schacht Alexander

    2008-07-01

    Full Text Available Abstract Background Conventional antipsychotics augmented with benzodiazepines have been the standard acute treatment for psychiatric emergencies for more than 50 years. The inability of patients to give informed consent limits randomised, controlled studies. This observational study on immediate therapy for aggression and impulse control in acutely agitated patients (IMPULSE evaluated the short-term effectiveness and tolerability of atypical and typical antipsychotic medications (AP in a non-interventional setting. Methods This was a comparative, non-randomised, prospective, open-label, observational study. Treatment over the first 5 days was classified according to whether any olanzapine, risperidone, or haloperidol was included or not. Documentations (PANSS-excited component, CGI-aggression, CGI-suicidality, tranquilisation score were at baseline (day 1 and days 2–6 after start of AP. Results During the short treatment-period, PANSS-EC and CGI-aggression scores improved in all cohorts. 68.7% of patients treated with olanzapine, 72.2% of patients treated with risperidone, and 83.3% of patients treated with haloperidol received concomitant benzodiazepines (haloperidol vs. non-haloperidol: p Conclusion Current medication practices for immediate aggression control are effective with positive results present within a few days. In this study, concomitant benzodiazepine use was significantly more frequent in patients receiving haloperidol.

  20. 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

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. Use of a multi-process phytoremediation system for decontamination of petroleum impacted soils : results of successful field trials

    Energy Technology Data Exchange (ETDEWEB)

    Greenberg, B.M.; Gurska, J.; Huang, X.D.; Gerhardt, K.E.; Yu, X.M.; Nykamp, J.; MacNeill, G.; Yang, S.; Lu, X.; Glick, B. [Waterloo Univ., ON (Canada). Dept. of Biology]|[Waterloo Environmental Biotechnology Inc., Hamilton, ON (Canada); Wang, W.; Knezevich, N. [Waterloo Univ., ON (Canada). Dept. of Biology; Gerwing, P.; Cryer, K. [Earthmaster Environmental Strategies Inc., Calgary, AB (Canada); Reid, N. [EBA Engineering Consultants Ltd., Edmonton, AB (Canada)

    2008-07-01

    The multi-process phytoremediation system (MPPS) was developed to degrade petroleum hydrocarbons (PHCs) in impacted soils. Phytoremediation of persistent contaminants in soils holds significant promise for rapid remediation kinetics. MPPS effectively removes polycyclic aromatic hydrocarbons (PAHs), total petroleum hydrocarbons (TPHs) and chlorinated hydrocarbons (CHCs) from soils. A plant growth promoting rhizobacteria interaction is the main element for success as it mitigates stress ethylene effects in plants, leading to high root biomass which, in turn, promotes growth of rhizosphere organisms. Field tests of the MPPS were initiated at a farm site in Sarnia, Ontario in the summer of 2004. The field was contaminated with petroleum hydrocarbons from refinery oil sludge. The second field trial was performed for 3 consecutive years at a petroleum contaminated biopile in Turner Valley, Alberta. The paper presented the results of the successful field tests of the MPPS. It was concluded that increased root biomass is achieved in the contaminated soils, which leads to more efficient and complete removal of TPHs in the field. Three years of field trials of the MPPS showed that remediation continues with successive seasons. 28 refs., 1 tab., 3 figs.

  6. Associations Between Ankle-Brachial Index and Cognitive Function: Results from the Lifestyle Interventions and Independence for Elders Trial

    Science.gov (United States)

    Espeland, Mark A.; Newman, Anne B.; Sink, Kaycee; Gill, Thomas M.; King, Abby C.; Miller, Michael E.; Guralnik, Jack; Katula, Jeff; Church, Timothy; Manini, Todd; Reid, Kieran F.; McDermott, Mary M.

    2015-01-01

    OBJECTIVE To evaluate cross-sectional and longitudinal associations between ankle-brachial index (ABI) and indicators of cognitive function DESIGN Randomized clinical trial (Lifestyle Interventions and Independence for Elders Trial) SETTING Eight US academic centers PARTICIPANTS 1,601 adults (ages 70–89 years, sedentary, non-demented, and with functional limitations MEASUREMENTS Baseline ABI and interviewer- and computer-administered cognitive function assessments were obtained from which compared a physical activity intervention with a health education control. Cognitive function was re-assessed 24 months later (interviewer-administered) and 18 or 30 months later (computer-administered) and central adjudication was used to classify individuals as having mild cognitive impairment, probable dementia, or neither. RESULTS Lower ABI had a modest independent association poorer cognitive functioning at baseline (partial r=0.09; p<0.001). While, lower baseline ABI was not associated with overall changes in cognitive function test scores, it was associated with higher odds for two-year progression to a composite of either mild cognitive impairment or probable dementia (OR=2.60 per unit lower ABI; 95% confidence interval [1.06,6.37]). Across two years, changes in ABI were not associated with changes in cognitive function. CONCLUSION In an older cohort of non-demented sedentary individuals with functional limitations, lower baseline ABI was independently correlated with cognitive function and associated with greater 2-year risk for progression to mild cognitive impairment or probable dementia. PMID:25869993

  7. 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

  8. Scaling-up from an implementation trial to state-wide coverage: results from the preliminary Melbourne Diabetes Prevention Study

    Directory of Open Access Journals (Sweden)

    Janus Edward D

    2012-08-01

    Full Text Available Abstract Background The successful Greater Green Triangle Diabetes Prevention Program (GGT DPP, a small implementation trial, has been scaled-up to the Victorian state-wide ‘Life!’ programme with over 10,000 individuals enrolled. The Melbourne Diabetes Prevention Study (MDPS is an evaluation of the translation from the GGT DPP to the Life! programme. We report results from the preliminary phase (pMDPS of this evaluation. Methods The pMDPS is a randomised controlled trial with 92 individuals aged 50 to 75 at high risk of developing type 2 diabetes randomised to Life! or usual care. Intervention consisted of six structured 90-minute group sessions: five fortnightly sessions and the final session at 8 months. Participants underwent anthropometric and laboratory tests at baseline and 12 months, and provided self-reported psychosocial, dietary, and physical activity measures. Intervention group participants additionally underwent these tests at 3 months. Paired t tests were used to analyse within-group changes over time. Chi-square tests were used to analyse differences between groups in goals met at 12 months. Differences between groups for changes over time were tested with generalised estimating equations and analysis of covariance. Results Intervention participants significantly improved at 12 months in mean body mass index (−0.98 kg/m2, standard error (SE = 0.26, weight (−2.65 kg, SE = 0.72, waist circumference (−7.45 cm, SE = 1.15, and systolic blood pressure (−3.18 mmHg, SE = 1.26, increased high-density lipoprotein-cholesterol (0.07 mmol/l, SE = 0.03, reduced energy from total (−2.00%, SE = 0.78 and saturated fat (−1.54%, SE = 0.41, and increased fibre intake (1.98 g/1,000 kcal energy, SE = 0.47. In controls, oral glucose at 2 hours deteriorated (0.59 mmol/l, SE = 0.27. Only waist circumference reduced significantly (−4.02 cm, SE = 0.95. Intervention participants significantly

  9. Classification of physiologically significant pumping states in an implantable rotary blood pump: patient trial results.

    Science.gov (United States)

    Karantonis, Dean M; Mason, David G; Salamonsen, Robert F; Ayre, Peter J; Cloherty, Shaun L; Lovell, Nigel H

    2007-01-01

    An integral component in the development of a control strategy for implantable rotary blood pumps is the task of reliably detecting the occurrence of left ventricular collapse due to overpumping of the native heart. Using the noninvasive pump feedback signal of impeller speed, an approach to distinguish between overpumping (or ventricular collapse) and the normal pumping state has been developed. Noninvasive pump signals from 10 human pump recipients were collected, and the pumping state was categorized as either normal or suction, based on expert opinion aided by transesophageal echocardiographic images. A number of indices derived from the pump speed waveform were incorporated into a classification and regression tree model, which acted as the pumping state classifier. When validating the model on 12,990 segments of unseen data, this methodology yielded a peak sensitivity/specificity for detecting suction of 99.11%/98.76%. After performing a 10-fold cross-validation on all of the available data, a minimum estimated error of 0.53% was achieved. The results presented suggest that techniques for pumping state detection, previously investigated in preliminary in vivo studies, are applicable and sufficient for use in the clinical environment.

  10. Negative symptom improvement during cognitive rehabilitation: results from a 2-year trial of Cognitive Enhancement Therapy.

    Science.gov (United States)

    Eack, Shaun M; Mesholam-Gately, Raquelle I; Greenwald, Deborah P; Hogarty, Susan S; Keshavan, Matcheri S

    2013-08-30

    Cognitive rehabilitation has shown beneficial effects on cognition in patients with schizophrenia, which may also help to improve negative symptoms due to overlapping pathophysiology between these two domains. To better understand the possible relationship between these areas, we conducted an exploratory analysis of the effects of Cognitive Enhancement Therapy (CET) on negative symptoms. Early course schizophrenia outpatients (n=58) were randomized to 2 years of CET or an Enriched Supportive Therapy (EST) control condition. Results revealed significant and medium-sized (d=0.61) differential improvements favoring CET in overall negative symptoms, particularly social withdrawal, affective flattening, and motor retardation. Neurocognitive improvement was associated with reduced negative symptoms in CET, but not EST patients. No relationships were observed between improvements in emotion processing aspects of social cognition, as measured by the Mayer-Salovey-Caruso Emotional Intelligence Test, and negative symptoms. CET represents an effective cognitive rehabilitation intervention for schizophrenia that may also have benefits to negative symptoms. Future studies specifically designed to examine negative symptoms during the course of cognitive rehabilitation are needed.

  11. 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.

  12. Alemtuzumab in the treatment of multiple sclerosis: key clinical trial results and considerations for use.

    Science.gov (United States)

    Havrdova, Eva; Horakova, Dana; Kovarova, Ivana

    2015-01-01

    Alemtuzumab is a humanized monoclonal antibody therapy that has recently been approved in over 30 countries for patients with active relapsing-remitting multiple sclerosis. It acts by targeting CD52, an antigen primarily expressed on T and B lymphocytes, resulting in their depletion and subsequent repopulation. The alemtuzumab clinical development program used an active comparator, subcutaneous interferon beta-1a, to show that alemtuzumab is a highly efficacious disease-modifying therapy, with benefits on relapses, disability outcomes, and freedom from clinical disease and magnetic resonance imaging activity. The safety profile was consistent across studies and no new safety signals have emerged during follow-up in the extension study. Infusion-associated reactions are common with alemtuzumab, but rarely serious. Infection incidence was elevated with alemtuzumab in clinical studies; most infections were mild or moderate in severity. Autoimmune adverse events occurred in approximately a third of patients, manifesting mainly as thyroid disorders, and less frequently as immune thrombocytopenia or nephropathy. A comprehensive monitoring program lasting at least 4 years after the last alemtuzumab dose allows early detection and effective management of autoimmune adverse events. Further experience with alemtuzumab in the clinic will provide needed long-term data.

  13. The Scandinavian Propaten® trial – Final 5-year Results of a Randomized Trial Comparing Heparin Bonded PTFE Grafts (Propaten®) to standard PTFE Grafts in Fem-Fem and Fem-Pop Position

    DEFF Research Database (Denmark)

    Lindholt, Jes Sanddal; Houlind, Kim Christian; Gottschalksen, B;

    2016-01-01

    a randomized trial. Methods: Patients with intermittent claudication or critical limb ischaemia requiring femorofemoral or femoropopliteal bypass grafting were randomized in a clinical trial of Hb-PTFE versus standard PTFE in 11 Scandinavian centres between 2005 and 2009. Patients were followed up for 5 years...... with clinical assessment and surveillance Duplex ultrasound imaging. The primary endpoint of this study was primary patency. Secondary endpoints included major amputation and mortality. Results: Overall, 569 patients were enrolled in the randomized trial. Some 552 had follow-up data available for analysis...

  14. 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

  15. 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.

  16. Transvaginal/Transumbilical Hybrid—NOTES—Versus 3-Trocar Needlescopic Cholecystectomy: Short-term Results of a Randomized Clinical Trial

    Science.gov (United States)

    Knuth, Jürgen; Cerasani, Nicola; Sauerwald, Axel; Lefering, Rolf; Heiss, Markus Maria

    2015-01-01

    Objective: For cholecystectomy, both the needlescopic cholecystectomy (NC) 3-trocar technique using 2 to 3 mm trocars and the umbilical-assisted transvaginal cholecystectomy (TVC) technique have found their way into clinical routine. This study compares these 2 techniques in female patients who are in need of an elective cholecystectomy. Background: Natural orifice transluminal endoscopic surgery (NOTES) is a surgical concept permitting scarless intra-abdominal operations through natural orifices, such as the vagina. Because of the lack of an adequately powered trial, we designed this first randomized controlled study for the comparison of TVC and NC. Methods: This prospective, randomized, nonblinded, single-center trial evaluates the safety and effectiveness of TVC (intervention), compared with NC (control) in female patients with symptomatic cholecystolithiasis. The primary endpoint was intensity of pain until the morning of postoperative day (POD) 2. Secondary outcomes were among others intra- and postoperative complications, procedural time, amount of analgesics used, pain intensity until POD 10, duration of hospital stay, satisfaction with the aesthetic result, and quality of life on POD 10 as quantified with the Eypasch Gastrointestinal Quality of Life Index (GIQLI). Results: Between February 2010 and June 2012, 40 patients were randomly assigned to the interventional or control group. All patients completed follow-up. Procedural time, length of postoperative hospital stay, and the rate of intra- and postoperative complications were similar in the 2 groups. However, significant advantages were found for the transvaginal access regarding pain until POD 2, but also until POD 10 (P = 0.043 vs P = 0.010) despite significantly less use of peripheral analgesics (P = 0.019). In the TVC group, patients were significantly more satisfied with the aesthetic result (P < 0.001) and had a significantly better GIQLI (P = 0.028). Conclusions: Although comparable in terms of

  17. Efficiency and safety of leflunomide in rheumatoid arthritis: Results of a Russian observational multicenter of trial

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    R. M. Balabanova

    2015-01-01

    Full Text Available Methotrexate or leflunomide is used as a first-line synthetic disease-modifying anti-rheumatic drug in the therapy of rheumatoid arthritis (RA. In 2011, the Russian Federation registered and since it has been successfully using leflunomide**.Objective: to evaluate the efficacy and tolerability of leflunomide** used to treat RA in routine clinical practice.Subjects and methods.The investigation enrolled patients with varying duration of RA that met the 1987 classification criteria. The patients were followed up in 33 healthcare facilities of Russia from March 2013 to October 2014. A total of 235 patients were randomized; the data of 196 patients were statistically processed. The mean age of the patients was 52.4±11.8 years; the mean duration of the disease was 75.4±69.1 months. The disease activity estimated by DAS28 and CDAI were 5.5±1.2 and 35.1±14.3 scores, respectively. 105 and 57 patients had X-ray Stages II and III disease, respectively. 80.1% of the patients were positive for rheumatoid factor and anti-cyclic citrullinated peptide antibodies. According to the instruction of its use, leflunomide was administered in a dose of 100 mg/day during the first 3 days and then in that of 20 mg/day. When adverse reactions (ARs occurred, it was recommended that the daily dose of the drug was decreased to 10 mg. The patients were examined before and 1, 3, and 6 months after treatment. The investigators measured the number of tender joints (NTJ and that of swollen joints (NSJ, and visual analog scale (VAS pain intensity, performed a laboratory examination involving clinical blood test, erythrocyte sedimentation rate (ESR, and C-reactive protein (CRP, in patients during their visits to physicians. The disease activity was assessed with DAS28 and CDAI and ARs were recorded.Results. Six-month therapy reduced the mean NSJ from 10.9 to 7.5%, NTJ from 12.3 to 8.9, VAS pain intensity from 64.1 to 39.3 mm, on average, ESR from 37.04 to 23.6 mm/hr, and

  18. 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.

  19. 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

  20. 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

  1. Trachoma prevalence and associated risk factors in the gambia and Tanzania: baseline results of a cluster randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Emma M Harding-Esch

    Full Text Available BACKGROUND: Blinding trachoma, caused by ocular infection with Chlamydia trachomatis, is targeted for global elimination by 2020. Knowledge of risk factors can help target control interventions. METHODOLOGY/PRINCIPAL FINDINGS: As part of a cluster randomised controlled trial, we assessed the baseline prevalence of, and risk factors for, active trachoma and ocular C. trachomatis infection in randomly selected children aged 0-5 years from 48 Gambian and 36 Tanzanian communities. Both children's eyes were examined according to the World Health Organization (WHO simplified grading system, and an ocular swab was taken from each child's right eye and processed by Amplicor polymerase chain reaction to test for the presence of C. trachomatis DNA. Prevalence of active trachoma was 6.7% (335/5033 in The Gambia and 32.3% (1008/3122 in Tanzania. The countries' corresponding Amplicor positive prevalences were 0.8% and 21.9%. After adjustment, risk factors for follicular trachoma (TF in both countries were ocular or nasal discharge, a low level of household head education, and being aged ≥ 1 year. Additional risk factors in Tanzania were flies on the child's face, being Amplicor positive, and crowding (the number of children per household. The risk factors for being Amplicor positive in Tanzania were similar to those for TF, with the exclusion of flies and crowding. In The Gambia, only ocular discharge was associated with being Amplicor positive. CONCLUSIONS/SIGNIFICANCE: These results indicate that although the prevalence of active trachoma and Amplicor positives were very different between the two countries, the risk factors for active trachoma were similar but those for being Amplicor positive were different. The lack of an association between being Amplicor positive and TF in The Gambia highlights the poor correlation between the presence of trachoma clinical signs and evidence of C. trachomatis infection in this setting. Only ocular discharge was

  2. Introduction of clinical guidelines for the diagnosis and treatment of osteoarthrosis: results of a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Dmitri Mikhailovich Maksimov

    2012-01-01

    Full Text Available Objective: to evaluate the impact of the active introduction of clinical guidelines for the diagnosis and treatment of osteoarthrosis (OA by primary care physicians on the efficiency of performed therapy and patient adherence to treatment. Methods. This was an open pragmatic cluster randomized controlled trial covering 16 general practitioners who completed the trial and 92 patients clinically diagnosed as having knee and/or hip OA (63 in the intervention group and 29 in the control group. The intervention involved a one-day didactic educational seminar for the physicians, printed guideline materials, and patient brochures. The control group physicians received no additional information support. WOMAC pain and stiffness scores, body mass index (BMI, adherence to treatment (nonsteroidal anti-inflammatory drugs (NSAIDs, therapeutic exercises, alternative treatments at 6 and 12 months after the intervention were taken into account when evaluating therapeutic effectiveness. Results. In the intervention group, the mean WOMAC pain scores were 6.9 and 13.3 points lower than in the controls at 6 (p = 0.16 and 12 (p = 0.017 months, respectively. The mean WOMAC stiffness scores in the intervention group were 6.7 and 14.7 points lower than in the controls at 6 (p = 0.29 and 12 (p = 0.039 months, respectively. The proportion of the patients using an alternative treatment dramatically decreased in the intervention group by 23 and 33% at 6 (p = 0.044 and 12 (p = 0.024 months, respectively. In the intervention group, the change in other parameters was less conclusive: by the end of the year, BMI slightly decreased (-1 kg/m 2; p = 0.95; the regular usage of NSAID reduced by 3% at 6 month (p = 0.7 and then increased by 10% at 12 month (p = 0.21. Adherence to regular physical exercises in the intervention group was 13 and 9% higher than in the controls at 6 (p = 0.23 and 12 (p = 0.42 months, respectively. Conclusion. The introduction of the clinical guidelines

  3. Fluvastatin in the first-line therapy of acute coronary syndrome: results of the multicenter, randomized, double-blind, placebo-controlled trial (the FACS-trial)

    OpenAIRE

    Telekes Peter; Holm Frantisek; Slaby Josef; Aschermann Ondrej; Wiendl Martin; Kettner Jiri; Kvapil Milan; Mates Martin; Hajek Petr; Macek Milan; Kukacka Jiri; Vejvoda Jiri; Alan David; Ostadal Petr; Horak David

    2010-01-01

    Abstract Background Statins have been proved to be effective in reduction of mortality and morbidity when started in the early secondary prevention in stabilized patients after acute coronary syndrome (ACS). The safety and efficacy of statin administration directly in the first-line therapy in unstable ACS patients is not clear. The aim of our study was, therefore, to assess the effect of statin treatment initiated immediately at hospital admission of patients with ACS. Methods The trial was ...

  4. 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…

  5. Brief Strategic Family Therapy versus Treatment as Usual: Results of a Multisite Randomized Trial for Substance Using Adolescents

    Science.gov (United States)

    Robbins, Michael S.; Feaster, Daniel J.; Horigian, Viviana E.; Rohrbaugh, Michael; Shoham, Varda; Bachrach, Ken; Miller, Michael; Burlew, Kathleen A.; Hodgkins, Candy; Carrion, Ibis; Vandermark, Nancy; Schindler, Eric; Werstlein, Robert; Szapocznik, Jose

    2011-01-01

    Objective: To determine the effectiveness of brief strategic family therapy (BSFT; an evidence-based family therapy) compared to treatment as usual (TAU) as provided in community-based adolescent outpatient drug abuse programs. Method: A randomized effectiveness trial in the National Drug Abuse Treatment Clinical Trials Network compared BSFT to…

  6. 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.

  7. 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.

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

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    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.

  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. 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

  11. 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...

  12. How Do Clinical Trials Work?

    Science.gov (United States)

    ... Studies NHLBI Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a clinical ... protect patients and help produce reliable study results. Clinical Trial Protocol Each clinical trial has a master plan ...

  13. On being grateful and kind: results of two randomized controlled trials on study-related emotions and academic engagement.

    Science.gov (United States)

    Ouweneel, Else; Le Blanc, Pascale M; Schaufeli, Wilmar B

    2014-01-01

    Despite the large amount of research attention to engagement as well as positive psychology in a general context, there have been few attempts to increase academic well-being by means of positive psychological interventions. This article tests the potential of positive psychological interventions to enhance study-related positive emotions and academic engagement, and to reduce study-related negative emotions among university students. We modified two existing positive interventions that are aimed at increasing general happiness for use in an academic context. These interventions focused on "thoughts of gratitude" and "acts of kindness," respectively. The present study consisted of two randomized controlled trials with experimental (thoughts of gratitude or acts of kindness) and control conditions in which participants were monitored on a daily basis during the one-week intervention, and additional pre-, post-, and follow-up assessments were carried out. Results revealed that the gratitude intervention had a significant positive effect on daily positive emotions only. The kindness intervention had a positive influence on both positive emotions and academic engagement, though not in the long run. The results showed no effects on negative emotions in either of the two interventions. Positive psychological interventions seem to foster positive emotions and academic engagement, but do not decrease negative emotions.

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

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    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.

  15. Dissonance-Based Prevention of Eating Disorder Risk Factors in Middle School Girls: Results from Two Pilot Trials

    Science.gov (United States)

    Rohde, Paul; Auslander, Beth A.; Shaw, Heather; Raineri, Kate M.; Gau, Jeff M.; Stice, Eric

    2014-01-01

    Objective Although several eating disorder prevention programs reduce eating disorder risk factors and symptoms for female high school and college students, few efficacious prevention programs exist for female middle school students, despite the fact that body image and eating disturbances often emerge then. Two pilot trials evaluated a new dissonance-based eating disorder prevention program for middle school girls with body image concerns. Methods Female middle school students with body dissatisfaction from two sites (Study 1: N = 81, M age = 12.1, SD = 0.9; Study 2: N = 52, M age = 12.5, SD = 0.8) were randomized to a dissonance intervention (MS Body Project) or educational brochure control; Study 2 included a 3-month follow-up. Results Intervention participants showed significant posttest reductions in only one of six variables with both Studies 1 and 2 (i.e., pressure to be thin and negative affect, respectively), though posttest effect sizes suggested medium reductions in eating disorder risk factors and symptoms (Study 1 M d = 0.40; Study 2 M d = 0.65); reductions at 3-month follow-up in Study 2 were not evident (M d = 0.19). Conclusions Results suggest that this new middle school version of the Body Project is producing medium magnitude reductions in eating disorder risk factors at posttest but that effects are showing limited persistence. Continued refinement and evaluation of this intervention appears warranted to develop more effective prevention programs for this age group. PMID:24590419

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

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    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

  17. THE RESULTS OF A PHASE III COMPARATIVE CLINICAL TRIAL OF RITUXIMAB (ACELLBIA® AND MABTHERA® IN RHEUMATOID ARTHRITIS (THE BIORA STUDY

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    E. L. Nasonov

    2016-01-01

    Full Text Available The article considers the results of an international multicenter randomized clinical trial of the efficacy and safety of the brand-name drug rituximab (MabThera, a monoclonal antibody against CD20 antigen of B cells, and its biosimi-lar drug (Acellbia® (the BIORA study in patients with rheumatoid arthritis (RA refractory to therapy with tumor necrosis factor-а inhibitors.Objective: to provide evidence for the therapeutic equivalence of Acellbia® and MabThera® and also to assess their interchangeability.Subjects and methods. The trial enrolled adult patients with active seropositive RA, who were randomized into two groups (1:1: 1 the patients who received Acellbia® 1000 mg intravenously on days 1 and 15; 2 those who had MabThera® in a similar way. When RA activity persisted at 24 weeks, there was re-randomization (1:1 with a partial overlap: Group 1 patients were randomized into group AA (the drug of the second therapy cycle was Acellbia® or Group AM (that was MabThera®, the similar methodology was followed in Group 2 (Groups MM and MA. Throughout the study, the patients received methotrexate at a stable dose of 7.5—25 mg/week and folic acid at a dose of 5 mg/week. The follow-up lasted 48 weeks.Results and discussion. 24 weeks after treatment initiation, the ACR20 response was observed in 84.1% of the patients in the Acellbia® group (95% CI, 74.75—90.50 and in 87% in the MabThera® group (95% CI, 77.71—92.79%; p = 0.773, which suggests that the drugs are therapeutically equivalent. In the second phase of the study, the efficiency of therapy remained high; there were no differences in Groups AA/MM, AA/AM and MM/MA. In both phases, the safety profile of the drugs was comparable; the immunogenicity of treatment remained low. The findings suggest that the brand-name MabThera® and its biosimilar drug Acellbia® are equivalent. Switching from the biosimilar drug to the brand-name one and vice versa has no negative impact on treatment

  18. Dexamethasone vs prednisone in induction treatment of pediatric ALL: results of the randomized trial AIEOP-BFM ALL 2000.

    Science.gov (United States)

    Möricke, Anja; Zimmermann, Martin; Valsecchi, Maria Grazia; Stanulla, Martin; Biondi, Andrea; Mann, Georg; Locatelli, Franco; Cazzaniga, Giovanni; Niggli, Felix; Aricò, Maurizio; Bartram, Claus R; Attarbaschi, Andishe; Silvestri, Daniela; Beier, Rita; Basso, Giuseppe; Ratei, Richard; Kulozik, Andreas E; Lo Nigro, Luca; Kremens, Bernhard; Greiner, Jeanette; Parasole, Rosanna; Harbott, Jochen; Caruso, Roberta; von Stackelberg, Arend; Barisone, Elena; Rössig, Claudia; Conter, Valentino; Schrappe, Martin

    2016-04-28

    Induction therapy for childhood acute lymphoblastic leukemia (ALL) traditionally includes prednisone; yet, dexamethasone may have higher antileukemic potency, leading to fewer relapses and improved survival. After a 7-day prednisone prephase, 3720 patients enrolled on trial Associazione Italiana di Ematologia e Oncologia Pediatrica and Berlin-Frankfurt-Münster (AIEOP-BFM) ALL 2000 were randomly selected to receive either dexamethasone (10 mg/m(2) per day) or prednisone (60 mg/m(2) per day) for 3 weeks plus tapering in induction. The 5-year cumulative incidence of relapse (± standard error) was 10.8 ± 0.7% in the dexamethasone and 15.6 ± 0.8% in the prednisone group (P < .0001), showing the largest effect on extramedullary relapses. The benefit of dexamethasone was partially counterbalanced by a significantly higher induction-related death rate (2.5% vs 0.9%, P = .00013), resulting in 5-year event-free survival rates of 83.9 ± 0.9% for dexamethasone and 80.8 ± 0.9% for prednisone (P = .024). No difference was seen in 5-year overall survival (OS) in the total cohort (dexamethasone, 90.3 ± 0.7%; prednisone, 90.5 ± 0.7%). Retrospective analyses of predefined subgroups revealed a significant survival benefit from dexamethasone only for patients with T-cell ALL and good response to the prednisone prephase (prednisone good-response [PGR]) (dexamethasone, 91.4 ± 2.4%; prednisone, 82.6 ± 3.2%; P = .036). In patients with precursor B-cell ALL and PGR, survival after relapse was found to be significantly worse if patients were previously assigned to the dexamethasone arm. We conclude that, for patients with PGR in the large subgroup of precursor B-cell ALL, dexamethasone especially reduced the incidence of better salvageable relapses, resulting in inferior survival after relapse. This explains the lack of benefit from dexamethasone in overall survival that we observed in the total cohort except in the subset of T-cell ALL patients with PGR. This trial was registered

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

    NARCIS (Netherlands)

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

    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

  20. 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

  1. 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.)

  2. Vaccination of metastatic melanoma patients with autologous dendritic cell (DC derived-exosomes: results of thefirst phase I clinical trial

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    Piperno Sophie

    2005-03-01

    Full Text Available Abstract Background DC derived-exosomes are nanomeric vesicles harboring functional MHC/peptide complexes capable of promoting T cell immune responses and tumor rejection. Here we report the feasability and safety of the first Phase I clinical trial using autologous exosomes pulsed with MAGE 3 peptides for the immunization of stage III/IV melanoma patients. Secondary endpoints were the monitoring of T cell responses and the clinical outcome. Patients and methods Exosomes were purified from day 7 autologous monocyte derived-DC cultures. Fifteen patients fullfilling the inclusion criteria (stage IIIB and IV, HLA-A1+, or -B35+ and HLA-DPO4+ leukocyte phenotype, tumor expressing MAGE3 antigen were enrolled from 2000 to 2002 and received four exosome vaccinations. Two dose levels of either MHC class II molecules (0.13 versus 0.40 × 1014 molecules or peptides (10 versus 100 μg/ml were tested. Evaluations were performed before and 2 weeks after immunization. A continuation treatment was performed in 4 cases of non progression. Results The GMP process allowed to harvest about 5 × 1014 exosomal MHC class II molecules allowing inclusion of all 15 patients. There was no grade II toxicity and the maximal tolerated dose was not achieved. One patient exhibited a partial response according to the RECIST criteria. This HLA-B35+/A2+ patient vaccinated with A1/B35 defined CTL epitopes developed halo of depigmentation around naevi, a MART1-specific HLA-A2 restricted T cell response in the tumor bed associated with progressive loss of HLA-A2 and HLA-BC molecules on tumor cells during therapy with exosomes. In addition, one minor, two stable and one mixed responses were observed in skin and lymph node sites. MAGE3 specific CD4+ and CD8+ T cell responses could not be detected in peripheral blood. Conclusion The first exosome Phase I trial highlighted the feasibility of large scale exosome production and the safety of exosome administration.

  3. 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

  4. 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.

  5. 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.

  6. Progress in the treatment of elderly/unfit chronic lymphocytic leukemia patients: results of the German CLL-11 trial.

    Science.gov (United States)

    Molica, Stefano

    2015-01-01

    Chronic lymphocytic leukemia (CLL) is the most prevalent type of leukemia and affects mostly the elderly. Chemoimmunotherapy with fludarabine, cyclophosphamide and rituximab is generally considered a standard treatment for younger fit patients with CLL. In a recent randomized Phase III study of patients with newly diagnosed CLL and coexisting conditions, obinutuzumab, a humanized anti-CD20 glycoengineered type 2 antibody, used in combination with chlorambucil, demonstrated significant improvement in progression-free survival and several other outcome parameters, in comparison to rituximab plus chlorambucil. Grade 3-4 infusion-related reactions and neutropenia occurred more frequently in patients who received obinutuzumab compared with those who received rituximab; however, the rate of serious infections was similar. Results of this trial clearly established that obinutuzumab in combination with chlorambucil represent the new first-line standard of treatment in this setting. A broad range of novel agents with different mechanisms of action have already proven their efficacy in CLL. New drugs targeting specific molecular features, such as ibrutinib, idelalisib or ABT-199, are being tested at present, and their advent is very likely to change the future treatment paradigm of CLL that relies today on chemoimmunotherapy for both fit and elderly/unfit patients.

  7. 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.

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

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    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.

  9. The efficacy of conjoint behavioral consultation on parents and children in the home setting: results of a randomized controlled trial.

    Science.gov (United States)

    Sheridan, Susan M; Ryoo, Ji Hoon; Garbacz, S Andrew; Kunz, Gina M; Chumney, Frances L

    2013-12-01

    The present study is a large-scale randomized trial testing the effects of a family-school partnership model (i.e., Conjoint Behavioral Consultation, CBC) for promoting behavioral competence and decreasing problem behaviors of children identified by their teachers as disruptive. CBC is a structured approach to problem-solving that involves consultants, parents, and teachers. The effects of CBC on family variables that are commonly associated with important outcomes among school-aged children (i.e., family involvement and parent competence in problem solving), as well as child outcomes at home, were evaluated. Participants were 207 children with disruptive behaviors from 91 classrooms in 21 schools in kindergarten through grade 3 and their parents and teachers. Results indicated that there were significantly different increases in home-school communication and parent competence in problem solving for participants in the CBC relative to control group. Likewise, compared to children in the control group, children in the CBC group showed significantly greater decreases in arguing, defiance, noncompliance, and tantrums. The degree of family risk moderated parents' competence in problem solving and children's total problem behaviors, teasing, and tantrums.

  10. Melphalan, lenalidomide and dexamethasone for the treatment of immunoglobulin light chain amyloidosis: results of a phase II trial.

    Science.gov (United States)

    Sanchorawala, Vaishali; Patel, Jaymin M; Sloan, J Mark; Shelton, Anthony C; Zeldis, Jerome B; Seldin, David C

    2013-05-01

    We report results of a phase II trial of combination of melphalan, lenalidomide, and dexamethasone for the treatment of immunoglobulin light chain (AL) amyloidosis. The primary objectives were tolerability and hematologic response rate; secondary objectives were organ responses and survival. Treatment protocol consisted of melphalan 5 mg/m(2)/day for four days, lenalidomide 10 mg/day for 21 days and dexamethasone 20-40 mg once a week every 28 days for a total of 12 cycles. Sixteen subjects were enrolled of whom 14 completed at least 3 cycles and were evaluable for response. Grade 3/4 toxicities were experienced by 88% (n=14), the most common being myelosuppression (n=7). Dose reductions occurred in 85% (n=12 of 14) of subjects. Hematologic partial and complete responses were achieved by 43% (n=6 of 14) and 7% (n=1 of 14), respectively. The median overall survival has not been reached and median progression-free survival is 24 months. In conclusion, this combination is associated with significant myelosuppression leading to dose modifications and producing minor hematologic responses in AL amyloidosis. http://clinicaltrials.gov/ct2/show/NCT00679367.

  11. 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.

  12. White pine blister rust resistance in North American, Asian and european species - results from artificial inoculartion trials in Oregon

    Directory of Open Access Journals (Sweden)

    R.A. Sniezko

    2013-12-01

    Full Text Available Dorena Genetic Resource Center (DGRC has used artificial inoculation trials to evaluate progenies of thousands of Pinus monticola and P. lambertiana selections from Oregon and Washington for resistance to white pine blister rust caused by Cronartium ribicola. In addition, early results are now available for P. albicaulis and P. strobiformis. DGRC has also recently evaluated seed orchard progenies of P. strobus, as well as bulked seedlots from P. armandii and P. peuce. The majority of P. monticola, P. lambertiana, P. albicaulis, and P. strobus progenies are very susceptible to blister rust. However, resistance exists in all these species. P. strobiformis showed relatively high levels of resistance for the eight progenies tested. Resistance in P. armandii was mainly reflected in the very low percentage of cankered seedlings; for P. peuce, the high percentage of cankered seedlings alive three years after inoculation was notable. R-genes are present in some of the North American five-needle pine species, but partial resistance traits (e.g. bark reaction will play a major role in breeding activities for P. monticola and P. lambertiana and will likely be the key to developing durable resistance.

  13. 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.

  14. Results of the AIEOP AML 2002/01 multicenter prospective trial for the treatment of children with acute myeloid leukemia.

    Science.gov (United States)

    Pession, Andrea; Masetti, Riccardo; Rizzari, Carmelo; Putti, Maria Caterina; Casale, Fiorina; Fagioli, Franca; Luciani, Matteo; Lo Nigro, Luca; Menna, Giuseppe; Micalizzi, Concetta; Santoro, Nicola; Testi, Anna Maria; Zecca, Marco; Biondi, Andrea; Pigazzi, Martina; Rutella, Sergio; Rondelli, Roberto; Basso, Giuseppe; Locatelli, Franco

    2013-07-11

    We evaluated the outcome of 482 children with acute myeloid leukemia (AML) enrolled in the Associazione Italiana di Ematologia e Oncologia Pediatrica AML 2002/01 trial. Treatment was stratified according to risk group; hematopoietic stem cell transplantation (HSCT) was used in high-risk (HR) children. Patients with core binding factor leukemia achieving complete remission (CR) after the first induction course were considered standard risk (SR; 99 patients), whereas the others (n = 383) were assigned to the HR group. Allogeneic (ALLO) or autologous (AUTO) HSCT was employed, respectively, in 141 and 102 HR patients after consolidation therapy. CR, early death, and induction failure rates were 87%, 3%, and 10%, respectively. Relapse occurred in 24% of patients achieving CR. The 8-year overall survival (OS), event-free survival (EFS), and disease-free survival (DFS) were 68%, 55%, and 63%, respectively. OS, EFS, and DFS for SR and HR patients were 83%, 63%, and 66% and 64%, 53%, and 62%. DFS was 63% and 73% for HR patients given AUTO-HSCT and ALLO-HSCT, respectively. In multivariate analysis, risk group, white blood cell >100 × 10(9)/L at diagnosis, and monosomal karyotype predicted poorer EFS. Risk-oriented treatment and broad use of HSCT result in a long-term EFS comparing favorably with previously published studies on childhood AML.

  15. 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

  16. Do results from major clinical trials indicate a change in management in the acute phase of myocardial infarction?

    Science.gov (United States)

    Hjalmarson, A

    1987-01-01

    Since introduction of modern Coronary Care Units, hospital mortality has been reduced by about 50%. This is most likely due to a number of treatments that today are well established. Those include detection and treatment of serious arrhythmias with antiarrhythmic agents and electrical conversion, and more aggressive early treatment of congestive heart failure, of chest pain, and of atrioventricular (AV) block and bradyarrhythmias. The new goals in early management of suspected acute myocardial infarction must aim at prevention and limitation of ischemic damage. The use of beta-blockers has been widely studied. Data from 27 randomized trials with a total of about 27,000 patients have convincingly shown that early beta-blockade reduces mortality, prevents and limits infarct development and arrhythmias, and reduces infarct complications. Three large trials, the Göteborg and MIAMI Trials on metoprolol and the ISIS Trial on atenolol, have demonstrated significant beneficial effects and good tolerance. Thrombolytic therapy in patients with signs of acute myocardial infarction, mainly streptokinase, has demonstrated significant reduction of short-term mortality. The large Italian GISSI Trial, including almost 12,000 patients, showed very significant reduction in 21 day mortality by streptokinase, and the earlier treatment started, the better the reduction. Pooling all published studies in the literature also shows the same favorable effects on mortality. Early treatment with thrombolytic therapy might also prevent and limit infarct development and preserve myocardial function. Recent large scale studies have convincingly demonstrated the value of early beta-blockade and of thrombolytic therapy in selected patients with signs of acute myocardial infarction. It seems reasonable to change the management in the acute phase of myocardial infarction based upon recent major clinical trials.

  17. 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...

  18. 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.)

  19. NGlycolylGM3/VSSP Vaccine in Metastatic Breast Cancer Patients: Results of Phase I/IIa Clinical Trial.

    Science.gov (United States)

    de la Torre, Ana; Hernandez, Julio; Ortiz, Ramón; Cepeda, Meylán; Perez, Kirenia; Car, Adriana; Viada, Carmen; Toledo, Darién; Guerra, Pedro Pablo; García, Elena; Arboláez, Migdacelys; Fernandez, Luis E

    2012-01-01

    Patients treated with vaccines based on NGlycolil gangliosides have showed benefit in progression free survival and overall survival. These molecules, which have been observed in breast cancer cells, are minimally or not expressed in normal human tissue and have been considered as antigen tumor-specific. For this reason they are very attractive to immunotherapy. A phase I/II clinical trial was carried out in metastatic breast cancer patients with the NGlycolylGM3/VSSP vaccine administered by subcutaneous route. Selecting the optimal biological doses of the vaccine in these patients was the principal objective based on the immunogenicity, efficacy and safety results. Six levels of doses of vaccine were studied. Treatment schedule consisted of five doses every two weeks and then monthly until reaching a fifteenth doses. Doses levels studied were 150, 300, 600, 900, 1200 and 1500 μg. Five patients in each level were included except at the 900 μg dose, in which ten patients were included. Immunogenicity was determined by levels of antibodies generated in patients after vaccination. The response criteria of evaluation in solid tumors (RECIST) was used to evaluate antitumoral effect. Safety was evaluated by Common Toxicity Criteria of Adverse Event (CTCAE). The vaccine administration was safe and immunogenic in all does levels. Most frequent adverse events related to vaccination were mild or moderate and were related to injection site reactions and "flu-like" symptoms. Vaccination induced specific anti-NeuGcGM3 IgM and IgG antibodies responses in all patients. Disease control (objective response or stable disease) was obtained in 72.7% of evaluated patients. Median overall survival was 15.9 months. Two patients of two different dose levels achieved overall survival values of about six years. The dose of 900 μg was selected as biological optimal dose in which overall survival was 28.5 months.

  20. 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.

  1. 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.

  2. 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

  3. Updated Results and Patterns of Failure in a Randomized Hypofractionation Trial for High-risk Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Arcangeli, Stefano [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Strigari, Lidia [Laboratory of Medical Physics and Expert Systems, Regina Elena National Cancer Institute, Rome (Italy); Gomellini, Sara; Saracino, Biancamaria; Petrongari, Maria Grazia; Pinnaro, Paola; Pinzi, Valentina [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy); Arcangeli, Giorgio, E-mail: arcangeli.gio@tiscali.it [Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome (Italy)

    2012-12-01

    Purpose: To report long-term results and patterns of failure after conventional and hypofractionated radiation therapy in high-risk prostate cancer. Methods and Materials: This randomized phase III trial compared conventional fractionation (80 Gy at 2 Gy per fraction in 8 weeks) vs hypofractionation (62 Gy at 3.1 Gy per fraction in 5 weeks) in combination with 9-month androgen deprivation therapy in 168 patients with high-risk prostate cancer. Freedom from biochemical failure (FFBF), freedom from local failure (FFLF), and freedom from distant failure (FFDF) were analyzed. Results: In a median follow-up of 70 months, biochemical failure (BF) occurred in 35 of the 168 patients (21%) in the study. Among these 35 patients, local failure (LF) only was detected in 11 (31%), distant failure (DF) only in 16 (46%), and both LF and DF in 6 (17%). In 2 patients (6%) BF has not yet been clinically detected. The risk reduction by hypofractionation was significant in BF (10.3%) but not in LF and DF. We found that hypofractionation, with respect to conventional fractionation, determined only an insignificant increase in the actuarial FFBF but no difference in FFLF and FFDF, when considering the entire group of patients. However, an increase in the 5-year rates in all 3 endpoints-FFBF, FFLF, and FFDF-was observed in the subgroup of patients with a pretreatment prostate-specific antigen (iPSA) level of 20 ng/mL or less. On multivariate analysis, the type of fractionation, iPSA level, Gleason score of 4+3 or higher, and T stage of 2c or higher have been confirmed as independent prognostic factors for BF. High iPSA levels and Gleason score of 4+3 or higher were also significantly associated with an increased risk of DF, whereas T stage of 2c or higher was the only independent variable for LF. Conclusion: Our results confirm the isoeffectiveness of the 2 fractionation schedules used in this study, although a benefit in favor of hypofractionation cannot be excluded in the subgroup of

  4. 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

  5. Early conversion from calcineurin inhibitor- to everolimus-based therapy following kidney transplantation : Results of the randomized ELEVATE trial

    NARCIS (Netherlands)

    de Fijter, Johan W; Holdaas, Hallvard; Øyen, Ole; Sanders, Jan Stephan; Sundar, Sankaran; Bemelman, Frederike J; Sommerer, Claudia; Pascual, Julio; Avihingsanon, Yingyos; Pongskul, Cholatip; Oppenheimer, Frederic; Toselli, Lorenzo; Russ, Graeme; Wang, Zailong; Lopez, Patricia; Kochuparampil, Jossy; Cruzado, Josep M; van der Giet, Markus

    2016-01-01

    In a 24-month, multicenter, open-label, randomized trial, 715 de novo kidney transplant recipients were randomized at 10-14 weeks to convert to everolimus (n=359) or remain on standard calcineurin inhibitor (CNI) therapy (n=356; 231 tacrolimus; 125 cyclosporine), all with mycophenolic acid and stero

  6. 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…

  7. 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

  8. 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...

  9. Changing Parent's Mindfulness, Child Management Skills and Relationship Quality with Their Youth: Results from a Randomized Pilot Intervention Trial

    Science.gov (United States)

    Coatsworth, J. Douglas; Duncan, Larissa G.; Greenberg, Mark T.; Nix, Robert L.

    2010-01-01

    We evaluated the efficacy of a mindful parenting program for changing parents' mindfulness, child management practices, and relationships with their early adolescent youth and tested whether changes in parents' mindfulness mediated changes in other domains. We conducted a pilot randomized trial with 65 families and tested an adapted version of the…

  10. Parent training in foster families with children with behavior problems : Follow-up results from a randomized controlled trial

    NARCIS (Netherlands)

    Maaskant, A.M.; van Rooij, F.B.; Overbeek, G.J.; Oort, F.J.; Hermanns, J.M.A.

    2016-01-01

    The present randomized controlled trial examined the four months follow-up effectiveness of Parent Management Training Oregon (PMTO) for parents with foster children (aged 4–12) with severe externalizing behavior problems in long-term foster care arrangements. The aim of PMTO, a relative long and in

  11. 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

  12. 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

  13. 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

  14. High School Students with Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention

    Science.gov (United States)

    Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G.; Fall, Anna-Mária; Schnakenberg, Jennifer B.

    2015-01-01

    A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state…

  15. [Position paper on the results of Symplicity HTN-3 trial. Grupo de estudio de la hipertensión arterial resistente].

    Science.gov (United States)

    Azpiri-López, José Ramón; Assad-Morell, José Luis; Ponce de León-Martínez, Enrique; Monreal-Puente, Rogelio; Dávila-Bortoni, Adrián; Vázquez-Díaz, Luis Alberto; Treviño-Frutos, Ramón Javier; Barrera-Oranday, Félix; Del Angel-Soto, Juan Gustavo; Martínez, José Guadalupe; Arellano-Torres, Marcelo

    2015-01-01

    Renal artery denervation has shown to be an effective treatment for resistant hypertension. Symplicity HTN 1 and 2 trials showed in small and uncontrolled groups, significant systolic blood pressure reductions down to 30 mm Hg. Symplicity HTN-3, a double blind, randomized, placebo controlled clinical trial shaded this initial enthusiasm. Surprisingly, their results showed that renal denervation has a similar effect to placebo. Pre-specified subgroup analysis showed that non-black race individuals, younger than 65 years and with normal renal function, had a statistically significant systolic blood pressure decrease. This manuscript critically appraises the Symplicity HTN-3 trial, proposing possible explanations for the results. Also declares our group position and future actions regarding renal denervation.

  16. Atypical meningioma: Randomized trials are required to resolve contradictory retrospective results regarding the role of adjuvant radiotherapy

    Directory of Open Access Journals (Sweden)

    Hannah Yoon

    2015-01-01

    Full Text Available Background: The role of postoperative radiation (RT in atypical meningioma remains controversial. Materials and Methods: We report a retrospective review of outcomes and prognostic factor analysis in 158 patients treated between 2000 and 2010, and extensively review the literature. Results: Following resection, 23 patients received immediate RT, whereas 135 did not. Median progression-free survival (PFS with and without RT was 59 (range 43-86 and 88 (range 64-123 months. For Simpson grade (G 1-3 resection, with and without RT, median PFS was 48 (2-80 versus 96 (88-123 months and for Simpson G4, it was 59 (6-86 versus 47 (15-104 months (P = 0.4. The rate of 5-year overall survival (OS with and without RT was 89% and 83%, respectively. On univariate analysis, Simpson G4 (HR 3.2, P = 0.0006 and brain invasion (HR 2.2, P = 0.03 were significantly associated with progression, whereas age >60 years (HR 9.7, P = 0.002, mitoses >5 per 10 high-power field (0.2, P = 0.0056, and Simpson G4 (HR 2.4, P = 0.07 were associated with higher risk of death. We summarized 22 additional reports, which provide very divergent results regarding the benefit of RT. Conclusions: In our series, adjuvant RT is surprisingly associated with worse PFS and OS, and this is more likely to be due to selection bias of referring tumors with more aggressive characteristics such as elevated Ki-67 and brain invasion for adjuvant RT, rather than a direct causal effect of adjuvant RT. Although there is a trend toward improved PFS with adjuvant RT after subtotal resection, no improvement was noted in OS. Multivariate analysis did not yield statistical significance for any of the factors including Simpson grades of resection, adjuvant RT, or six pathological defining features. The relatively divergent results in the literature are most likely explained by patient selection variability; therefore, randomized trials to adequately address this question are clearly necessary.

  17. Neoadjuvant capecitabine combined with standard radiotherapy in patients with locally advanced rectal cancer. Mature results of a phase II trial

    Energy Technology Data Exchange (ETDEWEB)

    Dunst, J. [Dept. of Radiotherapy, Univ. of Luebeck (Germany); Debus, J. [Univ. of Heidelberg (Germany); Rudat, V. [Univ. of Hamburg (Germany); Wulf, J. [Univ. of Wuerzburg (Germany); Budach, W. [Univ. of Tuebingen (Germany); Hoelscher, T. [Technical Univ., Dresden (Germany); Reese, T. [Martin Luther Univ., Halle (Germany); Mose, S.; Roedel, C. [Univ. of Frankfurt (Germany); Zuehlke, H. [Paul Gerhard Hospital, Wittenberg (Germany); Hinke, A. [WiSP GmbH, Langenfeld (Germany)

    2008-09-15

    Purpose: the objective of this expanded phase II trial was to confirm the safety results of the preceding phase I study and establish the efficacy of neoadjuvant radiochemotherapy with capecitabine in rectal cancer in a multicenter setting. Patients and methods: 96 patients (63% male, age 34-81 years) with advanced rectal cancer (cT3-4 or cN+) from seven university centers in Germany were recruited. All were to receive a total irradiation dose of 50.4-55.8 Gy with conventional fractions. Capecitabine was given at an oral dosage of 825 mg/m{sup 2} bid on each day of the radiotherapy period with the first daily dose applied 2 h before irradiation, followed by surgery 6 weeks later. Results: most of the patients suffered from an advanced primary tumor (cT3: 57%, cT4: 40%) with lymph node involvement in 60%. After neoadjuvant treatment, with a mean of 99% of the scheduled radiation dose actually delivered, a clinical response rate of 68% (95% confidence interval: 57-78%) was observed. Out of 87 evaluable patients undergoing surgery, a sphincter-preserving procedure could be performed in 51% and RO resection in 94%. A pathologically complete response was achieved in six patients (7%, 95% confidence interval: 3-14%). The comparison of initial diagnosis and pathologic findings showed a downstaging in 61%. Acute toxicity with > 5% incidence of NCI (National Cancer Institute) grade {>=} 3 included lymphopenia (12%), leukopenia (6%), and diarrhea (7%). Mild to moderate hand-foot syndrome occurred in 12% only. After a median follow-up of 48 months, the 5-year overall survival and tumor control data were, with regard to patient selection, in the expected range with an overall survival of 65%, a relapse-free survival of 47%, and a local recurrence rate after 5 years of 17%. Conclusion: the data clearly confirm that capecitabine is an adequate substitute for 5-fluorouracil in preoperative chemoradiation of rectal cancer with a favorable safety profile. (orig.)

  18. 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

  19. 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

  20. [Current controversies in glycemic control targets. What do the results of the latest clinical trials tell us about the approach to type 2 diabetes mellitus?].

    Science.gov (United States)

    Mauricio, Dídac; Rius, Ferran

    2010-09-01

    The aim of this article is to discuss the implications of the results obtained in the latest large-scale clinical trials designed to evaluate the effect of intensive glycemic control on the vascular complications associated with type 2 diabetes mellitus. The current scientific evidence is reviewed and the implications of the ACCORD (The Action to Control Cardiovascular Risk in Diabetes study group), ADVANCE (Action in Diabetes and Vascular disease: Preterax and Diamicron Modified Release Control Evaluation) and VADT (Veterans Affairs Diabetes Trial) clinical trials are discussed. General concerns of the studies and their implications for clinical practice and the management of type 2 diabetes, as well as the questions which still need to be answered by future clinical research are discussed.

  1. Lack of a Negative Effect of BCG-Vaccination on Child Psychomotor Development: Results from the Danish Calmette Study - A Randomised Clinical Trial

    DEFF Research Database (Denmark)

    Kjærgaard, Jesper; Stensballe, Lone Graff; Birk, Nina Marie;

    2016-01-01

    MEASURES: Psychomotor development measured using Ages and Stages Questionnaire (ASQ) completed by the parents at 12 months. Additionally, parents of premature children (gestational age Developmental assessment was available for 3453/4262 (81%). RESULTS......OBJECTIVES: To assess the non-specific effect of Bacillus Calmette-Guérin (BCG) vaccination at birth on psychomotor development. DESIGN: This is a pre-specified secondary outcome from a randomised, clinical trial. SETTING: Maternity units and paediatric wards at three university hospitals...... was -7.8 points (-20.6 to 5.0, p = 0.23), d = -0.23 (-0.62 to 0.15). CONCLUSIONS: A negative non-specific effect of BCG vaccination at birth on psychomotor development was excluded in term children. TRIAL REGISTRATION: ClinicalTrials.gov NCT01694108....

  2. 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

  3. 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

  4. 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

  5. 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. Karatee

    2016-01-01

    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 possibilitiesof 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 anti body 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 insufficientlyeffective, 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 to

  6. 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

  7. 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.

  8. 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

    participants were asked to investigate a panel of defined lyssavirus RNAs, consisting of Rabies virus (RABV) and European bat lyssavirus 1 and 2 (EBLV-1 and -2) RNA samples, with systems available in their laboratory. The ring trial allowed the important conclusion that conventional RT-PCR assays were really...... specifically designed on the use of reverse transcription polymerase chain reaction (RT-PCR) for detection of lyssavirus genomic RNA was organized. The trial focussed on assessment and comparison of the performance of conventional and real-time assays. In total, 16 European laboratories participated. All...... robust assays tested with a high concordance between different laboratories and assays. The real-time RT-PCR system by Wakeley et al. (2005) in combination with an intercalating dye, and the combined version by Hoffmann and co-workers (2010) showed good sensitivity for the detection of all RABV samples...

  9. 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

  10. Supporting Non-School Leaver Students in Their First Year of University Study: Results of a Transition Focused Peer-to-Peer Intensive Mentoring Program Trial

    Science.gov (United States)

    Larkin, Ashleigh; Dwyer, Angela

    2016-01-01

    This paper discusses the results of an intensive mentoring program trial designed to address retention issues with first year students in Justice degrees. The purpose of the program was to reduce student attrition, specifically for non-school leaver Justice students, by creating a culture of student cooperation and support. In line with previous…

  11. 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

  12. 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

  13. 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.

  14. 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...

  15. Long Term Effectiveness on Prescribing of Two Multifaceted Educational Interventions: Results of Two Large Scale Randomized Cluster Trials

    OpenAIRE

    Magrini, Nicola; Formoso, Giulio; Capelli, Oreste; Maestri, Emilio; Nonino, Francesco; Paltrinieri, Barbara; Giovane, Cinzia Del; Voci, Claudio; Magnano, Lucia; Daya, Lisa; Marata, Anna Maria; ,

    2014-01-01

    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...

  16. Sexual dysfunction during treatment of major depressive disorder with vilazodone, citalopram, or placebo: results from a phase IV clinical trial

    OpenAIRE

    Clayton, Anita H.; Gommoll, Carl; Chen, Dalei; Nunez, Rene; Mathews, Maju

    2015-01-01

    Sexual dysfunction commonly occurs with major depressive disorder (MDD). Vilazodone, a selective serotonin reuptake inhibitor and 5-HT1A receptor partial agonist antidepressant approved for the treatment of MDD in adults, was evaluated to determine its effects on sexual function. The primary study was a double-blind, randomized, controlled trial comparing vilazodone 20 and 40 mg/day with placebo; citalopram 40 mg/day was an active control (NCT01473381; http://www.clinicaltrials.gov). Post-hoc...

  17. Efficacy of dignity therapy for depression and anxiety in terminally-ill patients: early results of a randomized controlled trial

    OpenAIRE

    Julião, M.; Barbosa, A.; De Oliveira, F.; Nunes, Baltazar; Vaz Carneiro, A.

    2013-01-01

    Objective: Dignity therapy (DT) is a short-term psychotherapy developed for patients living with a life-limiting illness. Our aim was to determine the influence of DT on symptoms of depression and anxiety in people with a life-threatening disease with high level of distress, referred to an inpatient palliative care unit. Method: This was an open-label randomized controlled trial. Sixty terminally ill patients were randomly assigned to one of two groups: intervention group (DT+ standard pal...

  18. 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

  19. 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

  20. A randomised controlled trial to assess the effectiveness of offering study results as an incentive to increase response rates to postal questionnaires [ISRCTN26118436

    Directory of Open Access Journals (Sweden)

    Torgerson David J

    2005-10-01

    Full Text Available Abstract Background Postal questionnaires are widely used to collect outcome data on participants. However, a poor response to questionnaires will reduce the statistical power of the study and may introduce bias. A meta analysis of ten trials offering study results, largely in the fields of education and marketing, was shown to be ineffective, with the odds ratio for response with offering research findings is 0.92 (95% CI 0.75 to 1.11. However uncertainty still exists as it is uncertain whether results from such trials can be extrapolated to that of a health care setting. The aim of this study was to assess whether offering participants study results increases the response rates to postal questionnaires. Methods 1038 women aged over 70 years were remotely randomised by computer in a 3:1 ratio. 250 participants did not receive the offer of knowing the results of the trial and 788 participants were offered the results of the trial in a postal questionnaire. The main outcome measure was response rate. Chi square test was used to evaluate the overall differences in response rate between the two groups. An adjusted analysis, adjusting for whether the participant was taking calcium and age was also undertaken. Results The response rates were not significantly different Odds Ratio 0.88 (95% confidence intervals 0.48 to 1.63 p = 0.69. Conclusion Offering study results to women living in the community aged over 70 does not increase response rates to postal questionnaires. Although researchers have an ethical obligation to offer participants study results, since 10% of women did not wish to receive the results, investigators should give participants the option to opt out of receiving the study's results.

  1. 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

    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...... 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...

  2. Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Mahamadou A Thera

    Full Text Available BACKGROUND: The objective was to evaluate the safety and immunogenicity of the AMA1-based malaria vaccine FMP2.1/AS02(A in children exposed to seasonal falciparum 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/AS02(A is a recombinant protein (FMP2.1 based on apical membrane antigen 1 (AMA1 from the 3D7 clone of P. falciparum, formulated in the Adjuvant System AS02(A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert. One hundred healthy Malian children aged 1-6 years were recruited into 3 cohorts and randomized to receive either 10 microg FMP2.1 in 0.1 mL AS02(A, or 25 microg FMP2.1 in 0.25 mL AS02(A, or 50 microg FMP2.1 50 microg in 0.5 mL AS02(A, or rabies vaccine. Three doses of vaccine were given at 0, 1 and 2 months, and children were followed for 1 year. Solicited symptoms were assessed for 7 days and unsolicited symptoms for 30 days after each vaccination. Serious adverse events were assessed throughout the study. Transient local pain and swelling were common and more frequent in all malaria vaccine dosage groups than in the comparator group, but were acceptable to parents of participants. Levels of anti-AMA1 antibodies measured by ELISA increased significantly (at least 100-fold compared to baseline in all 3 malaria vaccine groups, and remained high during the year of follow up. CONCLUSION/SIGNIFICANCE: The FMP2.1/AS02(A vaccine had a good safety profile, was well-tolerated, and induced high and sustained antibody levels in malaria-exposed children. This malaria vaccine is being evaluated in a Phase 2 efficacy trial in children at this site. TRIAL REGISTRATION: ClinicalTrials.gov NCT00358332 [NCT00358332].

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

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    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

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

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    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

  5. Pomalidomide and dexamethasone in the treatment of AL amyloidosis: results of a phase 1 and 2 trial.

    Science.gov (United States)

    Sanchorawala, Vaishali; Shelton, Anthony C; Lo, Stephen; Varga, Cindy; Sloan, J Mark; Seldin, David C

    2016-08-25

    The objectives of a phase 1/2 trial of pomalidomide with dexamethasone for the treatment of light chain (AL) amyloidosis were to determine the safety, tolerability, maximum tolerated dose (MTD), recommended phase 2 dose, and hematologic and clinical response. A 3+3 dose-escalation phase (15 patients) was followed by an expansion cohort (12 patients) enrolled at the MTD. Pomalidomide was administered at 2 and 3 mg on days 1 to 28 (cohorts 1 and 2) and 4 mg on days 1 to 21 (cohort 3) every 28 days, with weekly dexamethasone at a dose of 20 mg. Twenty-seven patients with previously treated AL were enrolled, 15 during dose escalation (6 at 2 mg, 3 at 3 mg, and 6 at 4 mg) and 12 during dose expansion (all at 4 mg). One patient experienced dose-limiting toxicity at 4 mg; the MTD was determined as 4 mg. The most common grade ≥3 drug-related adverse events included myelosuppression and fatigue. Overall, hematologic response (HR) was 50% in 24 evaluable patients. The median time to best HR was 3 cycles, and median duration of HR was 15 months. Median overall survival has not yet been reached, with a median follow-up of 17.1 months and median event-free survival of 17.8 months. This trial was registered at www.clinicaltrials.gov as #NCT01570387.

  6. [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.

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

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    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

  8. Acyclovir Prophylaxis Reduces the Incidence of Herpes Zoster Among HIV-Infected Individuals: Results of a Randomized Clinical Trial.

    Science.gov (United States)

    Barnabas, Ruanne V; Baeten, Jared M; Lingappa, Jairam R; Thomas, Katherine K; Hughes, James P; Mugo, Nelly R; Delany-Moretlwe, Sinead; Gray, Glenda; Rees, Helen; Mujugira, Andrew; Ronald, Allan; Stevens, Wendy; Kapiga, Saidi; Wald, Anna; Celum, Connie

    2016-02-15

    Human immunodeficiency virus (HIV)-infected persons have higher rates of herpes zoster than HIV-uninfected individuals. We assessed whether twice daily treatment with 400 mg of oral acyclovir reduces the incidence of herpes zoster in a randomized, double-blind, placebo-controlled trial among 3408 persons coinfected with HIV and herpes simplex virus type 2. During 5175 person-years of follow-up, 26 cases of herpes zoster occurred among those assigned acyclovir, compared with 69 cases among those assigned placebo (rates, 1.00 and 2.68/100 person-years, respectively), a relative decrease of 62% (hazard ratio, 0.38; 95% confidence interval, .24-.67; P herpes zoster incidence among HIV-infected persons.

  9. High School Students With Reading Comprehension Difficulties: Results of a Randomized Control Trial of a Two-Year Reading Intervention.

    Science.gov (United States)

    Vaughn, Sharon; Roberts, Greg; Wexler, Jade; Vaughn, Michael G; Fall, Anna-Mária; Schnakenberg, Jennifer B

    2015-01-01

    A 2-year, randomized control trial with 9th to 10th grade students with significant reading problems was provided for 50 minutes a day in small groups. Comparison students were provided an elective class and treatment students the reading intervention. Students were identified as demonstrating reading difficulties through failure on their state accountability test and were randomly assigned to one of three treatment conditions and a business as usual (BAU) condition: reading without dropout prevention, reading with dropout prevention, dropout prevention without reading, or a BAU condition. Findings from the 2-year reading intervention (reading with and without dropout prevention combined and BAU) are reported in this article. Students in reading treatment compared to students in BAU demonstrated significant gains on reading comprehension (effect size = .43), and improved reading was associated with better grades in social studies. Findings from this study provide a rationale for further implementation and investigation of intensive intervention for high school students with reading difficulties.

  10. 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...... beneficial effect on the vitality domain of SF-36. Four MAA patients (14.8%) and two MNA patients (8%) discontinued interventions because of adverse effects. Our conclusion is that MAA has significant beneficial effects on OSA, including cure in some cases of severe OSA. Protrusion of the mandible...

  11. Platelet aggregation unchanged by lipoprotein-associated phospholipase A₂ inhibition: results from an in vitro study and two randomized phase I trials.

    Directory of Open Access Journals (Sweden)

    Bonnie C Shaddinger

    Full Text Available BACKGROUND: We explored the theorized upregulation of platelet-activating factor (PAF- mediated biologic responses following lipoprotein-associated phospholipase A2 (Lp-PLA2 inhibition using human platelet aggregation studies in an in vitro experiment and in 2 clinical trials. METHODS AND RESULTS: Full platelet aggregation concentration response curves were generated in vitro to several platelet agonists in human plasma samples pretreated with rilapladib (selective Lp-PLA2 inhibitor or vehicle. This was followed by a randomized, double-blind crossover study in healthy adult men (n = 26 employing a single-agonist dose assay of platelet aggregation, after treatment of subjects with 250 mg oral rilapladib or placebo once daily for 14 days. This study was followed by a second randomized, double-blind parallel-group trial in healthy adult men (n = 58 also treated with 250 mg oral rilapladib or placebo once daily for 14 days using a full range of 10 collagen concentrations (0-10 µg/ml for characterizing EC50 values for platelet aggregation for each subject. Both clinical studies were conducted at the GlaxoSmithKline Medicines Research Unit in the Prince of Wales Hospital, Sydney, Australia. EC50 values derived from multiple agonist concentrations were compared and no pro-aggregant signals were observed during exposure to rilapladib in any of these platelet studies, despite Lp-PLA2 inhibition exceeding 90%. An increase in collagen-mediated aggregation was observed 3 weeks post drug termination in the crossover study (15.4% vs baseline; 95% confidence interval [CI], 3.9-27.0, which was not observed during the treatment phase and was not observed in the parallel-group study employing a more robust EC50 examination. CONCLUSIONS: Lp-PLA2 inhibition does not enhance platelet aggregation. TRIAL REGISTRATION: 1 Study 1: ClinicalTrials.gov NCT01745458 2 Study 2: ClinicalTrials.gov NCT00387257.

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

    Directory of Open Access Journals (Sweden)

    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.

  13. Understanding the fate of black (pyrogenic) carbon in soil: Preliminary results from a long term field trial

    Science.gov (United States)

    Meredith, Will; Ascough, Philippa; Bird, Michael; Large, David; Shen, Licheng; Snape, Colin

    2014-05-01

    Black carbon (BC, also known as pyrogenic carbon) is an 'inert' form of carbon and has been proposed as a means of long-term carbon sequestration, particularly by amending soils and sediments with BC known as biochar. While there is abundant anecdotal evidence of biochar stability over extended timescales it is essential to gain a greater understanding of the degree and mechanisms of biochar degradation in the environment. This study aims to quantitatively assess the stability of biochar by investigating samples from field degradation trials first buried during 2009 in a tropical soil, and recovered after 12 and 36 month intervals. Catalytic hydropyrolysis (HyPy) is a novel analytical tool for the isolation of BC [1] in which high hydrogen pressure (150 bar) and a sulphided Mo catalyst reductively remove the non-BC fraction of the chars, and so isolate the most stable portion of the biochar, defined as BC(HyPy). This method also allows for the non-BC(HyPy) fraction of a sample, which from charcoal is known to include small ring PAHs (oceans [5], implying that BC cycling could be faster than previously thought [6]. Longer term field trials will be required (analysis of the 36 month samples) to observe systematic changes in the PAH distribution of the non-BCC(HyPy) fractions isolated form aged chars, although natural analogues with a better constrained environmental history may also be useful. [1] Meredith, W. et al., 2012. Geochimica et Cosmochimica Acta 97, 131-147. [2] Ascough, P.L. et al., 2010. Radiocarbon 52, 1336-1350. [3] Lockhart, R.S. et al., 2013. Journal of Analytical and Applied Pyrolysis 104, 640-652. [4] Hockaday, W.C. et al., 2007. Geochimica et Cosmochimica Acta 71, 3432-3445. [5] Jaffe, R. et al., 2013. Science 340, 345-347. [6] Zimmerman, M. et al., 2012. Global Change Biology 18, 3306-3316.

  14. 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.

  15. 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).

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

    Directory of Open Access Journals (Sweden)

    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

  17. 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.

  18. Serelaxin as a potential treatment for renal dysfunction in cirrhosis: Preclinical evaluation and results of a randomized phase 2 trial

    Science.gov (United States)

    Hoy, Anna M.; Semple, Scott I.; Mungall, Will; Lennen, Ross J.; Moran, Carmel M.; Pellicoro, Antonella; Aucott, Rebecca L.; Severin, Thomas; Saini, Rajnish; Yates, Denise; Dongre, Neelesh; Duffield, Jeremy S.; Webb, David J.; Iredale, John P.; Hayes, Peter C.

    2017-01-01

    AKT/eNOS/NO signaling pathway in the kidney. In the randomized clinical study, infusion of serelaxin for 120 min increased total renal arterial blood flow by 65% (95% CI 40%, 95%; p vasodilation using serelaxin as a new treatment for renal dysfunction in cirrhosis, although further validation in patients with more advanced cirrhosis and renal dysfunction is required. Trial registration ClinicalTrials.gov NCT01640964 PMID:28245243

  19. Chronic pain after inguinal hernia repair with the ONSTEP versus the Lichtenstein technique, results of a double-blinded multicenter randomized clinical trial

    DEFF Research Database (Denmark)

    Andresen, Kristoffer; Burcharth, Jakob; Fonnes, Siv;

    2016-01-01

    PURPOSE: The open new simplified totally extraperitoneal (ONSTEP) technique for the repair of inguinal hernia was presented some years ago with promising initial results regarding chronic pain. We conducted a randomized clinical trial investigating the ONSTEP technique versus the Lichtenstein...... participants with primary unilateral hernias, having surgical repair of their hernia at one of five participating general surgical departments. At surgery, participants were allocated (1:1) to the ONSTEP or the Lichtenstein technique for inguinal hernia repair. Participants were followed up with questionnaires...... was not seen in the ONSTEP group. CONCLUSION: The ONSTEP technique was not superior to the Lichtenstein technique regarding chronic pain following repair of primary inguinal hernias in males. TRIAL REGISTRATION: https://clinicaltrials.gov NCT01753219....

  20. 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; Negrini, Stefano

    2016-01-01

    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

  1. Sexual dysfunction during treatment of major depressive disorder with vilazodone, citalopram, or placebo: results from a phase IV clinical trial.

    Science.gov (United States)

    Clayton, Anita H; Gommoll, Carl; Chen, Dalei; Nunez, Rene; Mathews, Maju

    2015-07-01

    Sexual dysfunction commonly occurs with major depressive disorder (MDD). Vilazodone, a selective serotonin reuptake inhibitor and 5-HT1A receptor partial agonist antidepressant approved for the treatment of MDD in adults, was evaluated to determine its effects on sexual function. The primary study was a double-blind, randomized, controlled trial comparing vilazodone 20 and 40 mg/day with placebo; citalopram 40 mg/day was an active control (NCT01473381; http://www.clinicaltrials.gov). Post-hoc analyses evaluated change from baseline to week 10 on the Changes in Sexual Functioning Questionnaire (CSFQ); no inferential statistics were performed. CSFQ scores increased for women [1.2 (citalopram) to 3.0 (vilazodone 40 mg)] and men [1.2 (vilazodone 40 mg) to 3.5 (placebo)] in all treatment groups. Greater changes in CSFQ scores were seen in responders [women: 2.33 (citalopram) to 5.06 (vilazodone 40 mg); men: 2.26 (vilazodone 40 mg) to 4.35 (placebo)] versus nonresponders. CSFQ change from baseline was small for patients with normal baseline sexual function; in patients with baseline sexual dysfunction, CSFQ scores improved across groups [women: 2.35 (citalopram) to 4.52 (vilazodone 40 mg); men 2.83 (vilazodone 40 mg) to 6.43 (placebo)]. Across treatment groups, baseline sexual function improved in women and men, MDD responders, and patients with baseline sexual dysfunction.

  2. 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

  3. Clinical response and relapse in patients with chronic low back pain following osteopathic manual treatment: results from the OSTEOPATHIC Trial.

    Science.gov (United States)

    Licciardone, John C; Aryal, Subhash

    2014-12-01

    Clinical response and relapse following a regimen of osteopathic manual treatment (OMT) were assessed in patients with chronic low back pain (LBP) within the OSTEOPATHIC Trial, a randomized, double-blind, sham-controlled study. Initial clinical response and subsequent stability of response, including final response and relapse status at week 12, were determined in 186 patients with high baseline pain severity (≥50 mm on a 100-mm visual analogue scale). Substantial improvement in LBP, defined as 50% or greater pain reduction relative to baseline, was used to assess clinical response at weeks 1, 2, 4, 6, 8, and 12. Sixty-two (65%) patients in the OMT group attained an initial clinical response vs. 41 (45%) patients in the sham OMT group (risk ratio [RR], 1.45; 95% confidence interval [CI], 1.11-1.90). The median time to initial clinical response to OMT in these patients was 4 weeks. Among patients with an initial clinical response prior to week 12, 13 (24%) patients in the OMT group vs. 18 (51%) patients in the sham OMT group relapsed (RR, 0.47; 95% CI, 0.26-0.83). Overall, 49 (52%) patients in the OMT group attained or maintained a clinical response at week 12 vs. 23 (25%) patients in the sham OMT group (RR, 2.04; 95% CI, 1.36-3.05). The large effect size for short-term efficacy of OMT was driven by stable responders who did not relapse.

  4. 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

  5. Effect of Visit‐to‐Visit Variation of Heart Rate and Systolic Blood Pressure on Outcomes in Chronic Systolic Heart Failure: Results From the Systolic Heart Failure Treatment With the I f Inhibitor Ivabradine Trial (SHIFT) Trial

    OpenAIRE

    Böhm, Michael; Robertson, Michele; Borer, Jeffrey; Ford, Ian; Komajda, Michel; Mahfoud, Felix; Ewen, Sebastian; Swedberg, Karl; Tavazzi, Luigi

    2016-01-01

    Background Elevated resting heart rate (HR) and low systolic blood pressure (SBP) are related to poor outcomes in heart failure (HF). The association between visit‐to‐visit variation in SBP and HR and risk in HF is unknown. Methods and Results In Systolic Heart Failure Treatment with the I f inhibitor ivabradine Trial (SHIFT) patients, we evaluated relationships between mean HR, mean SBP, and visit‐to‐visit variations (coefficient of variation [CV]=SD/mean×100%) in SBP and HR (SBP‐CV and HR‐C...

  6. How do researchers determine the difference to be detected in superiority trials? Results of a survey from a panel of researchers

    Directory of Open Access Journals (Sweden)

    Angèle Gayet-Ageron

    2016-07-01

    Full Text Available Abstract Background There is currently no guidance for selecting a specific difference to be detected in a superiority trial. We explored 3 factors that in our opinion should influence the difference to be detected (type of outcome, patient age group, and presence of treatment side-effects, and 3 that should not (baseline level of risk, logistical difficulties, and cost of treatment. Methods We conducted an experimental survey using a factorial design among 380 corresponding authors of randomized controlled trials indexed in Medline. Two hypothetical vignettes were submitted to participants: one described a trial of a new analgesic in mild trauma injuries, the other described a trial of a new chemotherapy among cancer patients. The first vignette tested the baseline level of risk, patient age-group, patient recruitment difficulties, and treatment side-effects. The second tested the baseline level of risk, patient age-group, type of outcome, and cost of treatment. The respondents were asked to select the smallest gain of effectiveness that should be detected by the trial. Results In vignette 1, respondents selected a median difference to be detected corresponding to an improvement of 7.0 % in pain control with the new treatment. In vignette 2, they selected a median difference to be detected corresponding to a reduction of 5.0 % in mortality or cancer recurrence with the new chemotherapy. In both vignettes, the difference to be detected decreased significantly with the baseline risk. The other factor influencing difference to be detected was the age group, but the impact of this factor was smaller. Cost, side-effects, outcome severity, or mention of logistical difficulties did not significantly impact the difference to be detected selected by participants. Conclusions Three of the anticipated effects conformed to our expectations (the effect of patient age, and absence of effect of the cost of treatment and of patient recruitment difficulties

  7. 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

  8. Thyroid function alters during neoadjuvant chemotherapy in breast cancer patients: results from the NEOZOTAC trial (BOOG 2010-01).

    Science.gov (United States)

    de Groot, S; Janssen, L G M; Charehbili, A; Dijkgraaf, E M; Smit, V T H B M; Kessels, L W; van Bochove, A; van Laarhoven, H W M; Meershoek-Klein Kranenbarg, E; van Leeuwen-Stok, A E; van de Velde, C J H; Putter, H; Nortier, J W R; van der Hoeven, J J M; Pijl, H; Kroep, J R

    2015-01-01

    This side study investigated the effect of chemotherapy on thyroid function and the extent to which it can predict pathological complete response (pCR) in patients with early breast cancer taking part in NEOZOTAC phase III trial, randomizing between neoadjuvant chemotherapy with or without additional zoledronic acid. Moreover, we examined the impact of thyroid function on toxicity. Serum samples of 38 patients were available for analyses. Free thyroxin (fT4) and thyroid stimulating hormone (TSH) levels were compared between baseline and before the 6th cycle and between subjects with and without pCR. The relation between toxicity and the variation in fT4 and TSH levels during chemotherapy was tested. Samples at baseline and before the 6th cycle were available for 31 and 21 patients, respectively. The mean baseline fT4 level was 16.0 pmol/L and TSH level 1.11 mU/L, and these did not differ between both arms at each time point. During six cycles of chemotherapy, fT4 levels decreased (p = 0.0001), and TSH levels increased significantly (p = 0.019). Interestingly, the decrease of fT4 was significantly greater in patients without nausea, vomiting, or neuropathy, than in patients with those side effects (p = 0.037, p = 0.043, and p = 0.050, respectively). Baseline TSH levels tended to be higher in patients with pCR (p = 0.035 univariate analysis and p = 0.074 multivariate analysis). Chemotherapy blunts thyroid function, which was associated with less side effects. These data urge further evaluation of the effects of thyroid function on toxicity and outcome of breast cancer therapy.

  9. Seal, replacement or monitoring amalgam restorations with occlusal marginal defects? Results of a 10-year clinical trial.

    Science.gov (United States)

    Moncada, G; Fernández, E; Mena, K; Martin, J; Vildósola, P; De Oliveira Junior, O B; Estay, J; Mjör, I A; Gordan, V V

    2015-11-01

    The aim of this prospective and blind clinical trial was to assess the effectiveness of sealing localized marginal defects of amalgam restoration that were initially scheduled to be replaced. A cohort of twenty six patients with 60 amalgam restorations (n=44Class I and n=16Class II), that presented marginal defects deviating from ideal (Bravo) according to USPHS criteria, were assigned to either sealing or replacement groups: A: sealing n=20, Replacement n=20, and no treatment (n=20). Two blind examiners evaluated the restorations at baseline (K=0.74) and after ten years (K=0.84) according with USPHS criteria, in four parameters: marginal adaptation (MA), secondary caries (SC), marginal staining (MS) and teeth sensitivity (TS). Multiple comparison of restorations degradation/upgrade was analyzed by Friedman test and the comparisons within groups were performed by Wilcoxon test. After 10 years, 44 restorations were assessed (73.3%), Group A: n=14 and Group B: n=16; and Group C: n=14 sealing and replacement amalgam restorations presented similar level of quality in MA (p=0.76), SC (p=0.25) and TS (p=0.52), while in MS (p=0.007) presented better performance in replacement group after 10-years. Most of the occlusal amalgam restorations with marginal gaps showed similar long term outcomes than the restorations were sealed, replaced, or not treated over a 10-year period. Most of the restorations of the three groups were clinically acceptable, under the studied parameters. All restorations had the tendency to present downgrade/deterioration over time.

  10. Effectiveness of Tai Chi on Physical and Psychological Health of College Students: Results of a Randomized Controlled Trial.

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    Guohua Zheng

    Full Text Available To investigate the effectiveness and safety of Tai Chi Chuan (TCC on physical and psychological health of college students.Two hundred six college students were recruited and randomly allocated to a control group or a TCC exercise group in an equal ratio. Participants in the control group were instructed to maintain their original activity level and those in the TCC exercise group received 12 weeks of TCC exercise training based on their original activity level. Physical and psychological outcomes were evaluated at baseline, 13 weeks and 25 weeks. Intention-to-treat analysis was performed for the above outcomes.Compared with the control group, the TCC exercise group showed significant improvements at the end of the 12-week intervention period for flexibility (length of Sit and Reach (cm: TCC group 14.09±7.40 versus control 12.88±6.57, P = 0.039 adjusted for its baseline measures using a general linear model and balance ability (open eyes perimeter: TCC group 235.6(191~314 versus control 261(216~300; closed eyes perimeter: TCC group 370.5 (284~454 versus control 367 (293~483; P = 0.0414, 0.008, respectively, adjusted for corresponding baseline measures using a general linear model. No significant changes in other physical and mental outcomes were found between the two groups. No adverse events were reported during the study period.TCC exercise was beneficial in college students for improving flexibility and balance capability to some extent, compared with usual exercise.Chinese Clinical Trial Registry ChiCTR-TRC-13003328.

  11. 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.

  12. Hypofractionated radiotherapy and stereotactic boost with concurrent and adjuvant temozolamide for glioblastoma in good performance status elderly patients – early results of a phase II trial.

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    Scott eFloyd

    2012-10-01

    Full Text Available Glioblastoma Multiforme (GBM is an aggressive primary brain neoplasm with dismal prognosis. Based on successful phase III trials, 60 Gy involved-field radiotherapy in 30 fractions over 6 weeks (Standard RT with concurrent and adjuvant temozolomide is currently the standard of care. In this disease, age and Karnofsky Performance Status (KPS are the most important prognostic factors. For elderly patients, clinical trials comparing standard RT with radiotherapy abbreviated to 40 Gy in 15 fractions over 3 weeks demonstrated similar outcomes, indicating shortened radiotherapy may be an appropriate option for elderly patients. However, these trials did not include temozolomide chemotherapy, and included patients with poor KPS, possibly obscuring benefits of more aggressive treatment for some elderly patients. We conducted a prospective Phase II trial to examine the efficacy of a hypofractionated radiation course followed by a stereotactic boost with concurrent and adjuvant temozolomide chemotherapy in elderly patients with good performance status. In this study, patients 65 years and older with a KPS >70 and histologically confirmed GBM received 40 Gy in 15 fractions with 3D conformal technique followed by a 1-3 fraction stereotactic boost to the enhancing tumor. All patients also received concurrent and adjuvant temozolomide. Patients were evaluated 1 month post-treatment and every 2 months thereafter. Between 2007 and 2010, 20 patients (9 males and 11 females were enrolled in this study. The median age was 75.4 years (range 65-87 years. At a median follow-up of 11 months (range 7-32 months, 12 patients progressed and 5 are alive. The median progression free survival was 11 months and the median overall survival was 13 months. There was no additional toxicity. These results indicate that elderly patients with good KPS can achieve outcomes comparable to the current standard of care using an abbreviated radiotherapy course, radiosurgery boost and

  13. The Feasibility and Effects of Acupuncture on Quality of Life Scores During Chemotherapy in Ovarian Cancer: Results from a Pilot, Randomized Sham-Controlled Trial

    Science.gov (United States)

    Matulonis, Ursula A.; Dunn, Julie E.; Lee, Hang; Doherty-Gilman, Anne; Dean-Clower, Elizabeth; Goodman, Annekathryn; Davis, Roger B.; Buring, Julie; Wayne, Peter; Rosenthal, David S.; Penson, Richard T.

    2012-01-01

    Abstract Background Within a pilot trial regarding chemotherapy-induced neutropenia, the secondary aim of the main study was explored. This involved measuring the effects—as shown on two key measurement scales reflecting quality of life (QoL)—of verum versus sham acupuncture on patients with ovarian cancer during chemotherapy. Objective The aim of this substudy was to determine the feasibility of determining the effects of verum acupuncture versus sham acupuncture on QoL in patients with ovarian cancer during chemotherapy. Design This was a randomized, sham-controlled trial. Setting The trial was conducted at two cancer centers. Patients Patients with ovarian cancer (N=21) who were receiving chemotherapy—primarily intravenous carboplatin and paclitaxel—participated in this substudy. Intervention The participants were given either active or sham acupuncture 1 week prior to cycle 2 of chemotherapy. There were ten sessions of acupuncture, with manual and electro-stimulation over a 4-week period. Main Outcome Measures The European Organization for Research and Treatment of Cancer-Quality-of-Life Questionnaire-Core 30 Item (EORTC-QLQ-C30) and the Quality of Life Questionnaire–Ovarian Cancer Module-28 Item (QLQ-OV28) were administered to the patients at baseline and at the end of their acupuncture sessions. Results Of the original 21, 15 patients (71%) completed the study, and 93% of them completed the questionnaires. The EORTC-QLQ-C30 subscores were improved in the acupuncture arm, including the mean scores of social function (SF), pain, and insomnia (p=0.05). However, after adjusting for baseline differences, only the SF score was significantly higher in the active acupuncture arm, compared with the sham acupuncture arm (p=0.03). Conclusions It appears feasible to conduct a randomized sham-controlled acupuncture trial measuring QoL for patients with ovarian cancer who are undergoing chemotherapy. Acupuncture may have a role in improving QoL during

  14. 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

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

    Directory of Open Access Journals (Sweden)

    Callis Duffin K

    2016-10-01

    Full Text Available Kristina Callis Duffin,1 Michael Bukhalo,2 Margaret A Bobonich,3 David Shrom,4 Fangyi Zhao,4 James R Kershner,4 Anne Gill,4 Beth Pangallo,4 Catherine L Shuler,4 Jerry Bagel5 1Department of Dermatology, University of Utah School of Medicine, Salt Lake City, UT, 2Arlington Dermatology, Arlington Heights, IL, 3CWRU Schools of Medicine and Nursing, Case Western Reserve University Cleveland, OH, 4Lilly Research Labs, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 5Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA 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

  16. Boron neutron capture therapy for glioblastoma multiforme using p-boronophenylalanine and epithermal neutrons: trial design and early clinical results.

    Science.gov (United States)

    Coderre, J A; Elowitz, E H; Chadha, M; Bergland, R; Capala, J; Joel, D D; Liu, H B; Slatkin, D N; Chanana, A D

    1997-05-01

    A Phase I/II clinical trial of boron neutron capture therapy (BNCT) for glioblastoma multiforme is underway using the amino acid analog p-boronophenylalanine (BPA) and the epithermal neutron beam at the Brook-haven Medical Research Reactor. Biodistribution studies were carried out in 18 patients at the time of craniotomy using an i.v. infusion of BPA, solubilized as a fructose complex (BPA-F). There were no toxic effects related to the BPA-F administration at doses of 130, 170, 210, or 250 mg BPA/kg body weight. The tumor/ blood, brain/blood and scalp/blood boron concentration ratios were approximately 3.5:1, 1:1 and 1.5:1, respectively. Ten patients have received BNCT following 2-hr infusions of 250 mg BPA/kg body weight. The average boron concentration in the blood during the irradiation was 13.0 +/- 1.5 micrograms 10B/g. The prescribed maximum dose to normal brain (1 cm3 volume) was 10.5 photon-equivalent Gy (Gy-Eq). Estimated maximum and minimum doses (mean +/- sd, n = 10) to the tumor volume were 52.6 +/- 4.9 Gy-Eq (range: 64.4-47.6) and 25.2 +/- 4.2 Gy-Eq (range: 32.3-20.0), respectively). The estimated minimum dose to the target volume (tumor +2 cm margin) was 12.3 +/- 2.7 Gy-Eq (range: 16.2-7.8). There were no adverse effects on normal brain. The scalp showed mild erythema, followed by epilation in the 8 cm diameter field. Four patients developed recurrent tumor, apparently in the lower dose (deeper) regions of the target volume, at post-BNCT intervals of 7,5,3.5 and 3 months, respectively. The remaining patients have had less than 4 months of post-BNCT follow-up. BNCT, at this starting dose level, appears safe. Plans are underway to begin the dose escalation phase of this protocol.

  17. NRTI Sparing Therapy in Virologically Controlled HIV-1 Infected Subjects: Results of a Controlled, Randomized Trial (Probe).

    Science.gov (United States)

    Maggiolo, Franco; Di Filippo, Elisa; Valenti, Daniela; Ortega, Paula S; Callegaro, Annapaola

    2016-05-01

    Dual treatments could help clinicians to avoid drawbacks and toxicities due to the nucleosidic backbone, while maintaining the efficacy and convenience of robust combination antiretroviral therapy (cART). We explored the combination of rilpivirine plus boosted darunavir (DRV) as an option when switching from standard cART in patients who are virologically suppressed. In this randomized, open-label, proof-of-concept, noninferiority trial, we recruited patients aged 18 years or older with chronic HIV-1 infection and on a stable, effective (>6 months) protease inhibitor-based cART including a nucleosidic backbone. The primary endpoint was noninferiority of the virological response between treatment groups, according to FDA snapshot approach. Sixty patients were randomly allocated to dual treatment with rilpivirine plus boosted DRV or to continue their ongoing triple treatment. Noninferiority was shown at the prespecified level of -12% both at 24 and 48 weeks. At week 24, 100% of patients in the dual arm presented a blood HIV-RNA level therapy arm. At week 48, the CD838HLADR cell count was 3.4% (SD, 2.2) in the dual-therapy arm and 5.2% (SD, 3.1) in the triple arm (P = 0.018). None of the patients developed severe adverse events nor had to stop treatment because of adverse events or presented grade 3-4 laboratory abnormalities. A greater reduction of bone stiffness (-2.25; SD, 7.1) was observed in patients randomized to continue triple therapy compared with patients switched to dual therapy (-0.32; SD, 8.8). Finally, baseline HIV-DNA content directly correlated with pre-cART viral load of patients (P = 0.021), but not with time on cART or time with HIV-RNA below 50 copies per milliliter. Independently of the study arm, patients with a n HIV-RNA level constantly above 3 copies per milliliter or showing viral blips had baseline HIV-DNA levels significantly higher (64,656 copies per 10 cells; SD, 93057) compared with patients who constantly presented a HIV-RNA level below

  18. 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

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    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

  19. Computerised cognitive–behavioural therapy for depression in adolescents: feasibility results and 4-month outcomes of a UK randomised controlled trial

    Science.gov (United States)

    Wright, Barry; Tindall, Lucy; Littlewood, Elizabeth; Allgar, Victoria; Abeles, Paul; Trépel, Dominic; Ali, Shehzad

    2017-01-01

    Objectives Computer-administered cognitive–behavioural therapy (CCBT) may be a promising treatment for adolescents with depression, particularly due to its increased availability and accessibility. The feasibility of delivering a randomised controlled trial (RCT) comparing a CCBT program (Stressbusters) with an attention control (self-help websites) for adolescent depression was evaluated. Design Single centre RCT feasibility study. Setting The trial was run within community and clinical settings in York, UK. Participants Adolescents (aged 12–18) with low mood/depression were assessed for eligibility, 91 of whom met the inclusion criteria and were consented and randomised to Stressbusters (n=45) or websites (n=46) using remote computerised single allocation. Those with comorbid physical illness were included but those with psychosis, active suicidality or postnatal depression were not. Interventions An eight-session CCBT program (Stressbusters) designed for use with adolescents with low mood/depression was compared with an attention control (accessing low mood self-help websites). Primary and secondary outcome measures Participants completed mood and quality of life measures and a service Use Questionnaire throughout completion of the trial and 4 months post intervention. Measures included the Beck Depression Inventory (BDI) (primary outcome measure), Mood and Feelings Questionnaire (MFQ), Spence Children's Anxiety Scale (SCAS), the EuroQol five dimensions questionnaire (youth) (EQ-5D-Y) and Health Utility Index Mark 2 (HUI-2). Changes in self-reported measures and completion rates were assessed by treatment group. Results From baseline to 4 months post intervention, BDI scores and MFQ scores decreased for the Stressbusters group but increased in the website group. Quality of life, as measured by the EQ-5D-Y, increased for both groups while costs at 4 months were similar to baseline. Good feasibility outcomes were found, suggesting the trial process to be

  20. 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

  1. [Clinical trial of the antibacterial combination sulfamoxole/trimethoprim (CN 3123)/Third communication: Clinical results of a field trial with CN 3123 in bronchopulmonary and ENT (ear/nose/throat) infections (author's transl)].

    Science.gov (United States)

    Etzel, M; Neuhof, F; Wesenberg, W

    1976-01-01

    The following conclusions emerged from an analysis of the therapeutic results documented during the clinical trial of N1-(4,5-dimethyl-2-oxazolyl)-sulfanilamide (sulfamoxole) and 2,4-diamino)-5-(3,4,5-trimethoxy-benzyl)-pyrimidine (trimethoprim) (CN 3123, Nevin, Supristol) in bacterial infections of the respiratory tract and ENT organs: 1. In bacterial infections of the bronchopulmonary system, the antibacterial activity of CN 3123 was demonstrated in 94% of the patients, in that 75% of patients were cured and there was a definite improvement in 19%. 2. In bacterial infections of the ENT organs, the antibacterial activity of CN 3123 was demonstrated clinically in 95% of the patients, in that 89% of the patients were cured and there was a definite improvement in 6%. 3. The clinical assessment of the activity of CN 3123 correlates closely with the results of bacteriological checks.

  2. The Frameless Copper IUD (GyneFix) and the TCu380A IUD : Results of an 8-year Multicenter Randomized Comparative Trial

    OpenAIRE

    Meirik, O.; Rowe, P J; Peregoudov, A.; Piaggio, G; Petzold, M.

    2009-01-01

    BACKGROUND: Clinical performance of the frameless copper IUD (GyneFix), designed to reduce side effects related to the frame of conventional IUDs, and TCu380A was compared. STUDY DESIGN: Randomized Multicenter randomized comparative trial. Parous women requesting and eligible to use IUD were admitted in 21 centers in eight countries in 1989-1993 and followed-up for up to 8 years. RESULTS: Two thousand twenty-seven women were randomized to the frameless IUD and 2036 to TCu380A; 43 insertions o...

  3. 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.

  4. 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.

  5. 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.

  6. The Erlangen Dose Optimization trial for low-dose radiotherapy of benign painful elbow 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)

    2014-03-15

    To evaluate the long-term efficacy of pain reduction by two dose fractionation schedules used for low-dose radiotherapy of painful elbow syndrome. Between February 2006 and February 2010, 199 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 9-57 months). The overall early, delayed and long-term response rates for all patients were 80, 90 and 94 %, 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 59.6 ± 20.2 and 55.7 ± 18.0 (p = 0.46); 32.1 ± 24.5 and 34.4 ± 22.5 (p = 0.26); 27.0 ± 27.7 and 23.5 ± 21.6 (p = 0.82) and 10.7 ± 15.0 and 21.5 ± 26.9 (p = 0.12), respectively. The mean CPS values before treatment and those for early, delayed and long-term response were 8.7 ± 2.9 and 8.1 ± 3.1 (p = 0.21); 4.5 ± 3.2 and 5.0 ± 3.4 (p = 0.51); 3.9 ± 3.6 and 2.8 ± 2.8 (p = 0.19) and 1.5 ± 2.3 and 2.4 ± 3.5 (p = 0.27), 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). Low-dose radiotherapy is an effective treatment for the management of benign painful elbow syndrome. For radiation protection reasons, the dose for a radiotherapy series should not exceed 3.0 Gy. (orig.) [German] Untersuchung der

  7. A case management intervention targeted to reduce healthcare consumption for frequent Emergency Department visitors: results from an adaptive randomized trial

    Science.gov (United States)

    Anderson, Jacqueline; Dolk, Anders; Torgerson, Jarl; Nyberg, Svante; Skau, Tommy; Forsberg, Birger C.; Werr, Joachim; Öhlen, Gunnar

    2016-01-01

    Background A small group of frequent visitors to Emergency Departments accounts for a disproportionally large fraction of healthcare consumption including unplanned hospitalizations and overall healthcare costs. In response, several case and disease management programs aimed at reducing healthcare consumption in this group have been tested; however, results vary widely. Objectives To investigate whether a telephone-based, nurse-led case management intervention can reduce healthcare consumption for frequent Emergency Department visitors in a large-scale setup. Methods A total of 12 181 frequent Emergency Department users in three counties in Sweden were randomized using Zelen’s design or a traditional randomized design to receive either a nurse-led case management intervention or no intervention, and were followed for healthcare consumption for up to 2 years. Results The traditional design showed an overall 12% (95% confidence interval 4–19%) decreased rate of hospitalization, which was mostly driven by effects in the last year. Similar results were achieved in the Zelen studies, with a significant reduction in hospitalization in the last year, but mixed results in the early development of the project. Conclusion Our study provides evidence that a carefully designed telephone-based intervention with accurate and systematic patient selection and appropriate staff training in a centralized setup can lead to significant decreases in healthcare consumption and costs. Further, our results also show that the effects are sensitive to the delivery model chosen. PMID:25969342

  8. 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

  9. Combination of Trabectedin and Gemcitabine for Advanced Soft Tissue Sarcomas: Results of a Phase I Dose Escalating Trial of the German Interdisciplinary Sarcoma Group (GISG

    Directory of Open Access Journals (Sweden)

    Bernd Kasper

    2015-01-01

    Full Text Available Background: Evaluation of the potential efficacy and safety of combination therapies for advanced soft tissue sarcomas (STS has increased substantially after approval of trabectedin and pazopanib. Trabectedin's introduction in Europe in 2007 depended mainly on its activity in so-called L-sarcomas (liposarcoma and leiomyosarcoma; combination of trabectedin with other chemotherapies used in STS seems of particular interest. Methods: We initiated within the German Interdisciplinary Sarcoma Group (GISG a phase I dose escalating trial evaluating the combination of trabectedin and gemcitabine in patients with advanced and/or metastatic L-sarcomas (GISG-02; ClinicalTrials.gov NCT01426633. Patients were treated with increasing doses of trabectedin and gemcitabine. The primary endpoint was to determine the maximum tolerated dose. Results: Five patients were included in the study. Two patients were treated on dose level 1 comprising trabectedin 0.9 mg/m2 on day 1 and gemcitabine 700 mg/m2 on days 1 + 8, every 3 weeks. Due to dose-limiting toxicity (DLT in both patients (elevated transaminases and thrombocytopenia, an additional three patients were treated on dose level −1 with trabectedin 0.7 mg/m2 plus gemcitabine 700 mg/m2. Of these three patients, two demonstrated another DLT; therefore, the trial was stopped and none of the dose levels could be recommended for phase II testing. Conclusion: The GISG-02 phase I study was stopped with the conclusion that the combination of gemcitabine and trabectedin is generally not recommended for the treatment of patients with advanced and/or metastatic leiomyosarcoma or liposarcoma. Also, this phase I study strongly supports the necessity for careful evaluation of combination therapies.

  10. Diffuse intrinsic pontine glioma treated with prolonged temozolomide and radiotherapy--results of a United Kingdom phase II trial (CNS 2007 04).

    Science.gov (United States)

    Bailey, S; Howman, A; Wheatley, K; Wherton, D; Boota, N; Pizer, B; Fisher, D; Kearns, P; Picton, S; Saran, F; Gibson, M; Glaser, A; Connolly, D J A; Hargrave, D

    2013-12-01

    Diffuse intrinsic pontine glioma (DIPG) has a dismal prognosis with no chemotherapy regimen so far resulting in any significant improvement over standard radiotherapy. In this trial, a prolonged regimen (21/28d) of temozolomide was studied with the aim of overcoming O(6)-methylguanine methyltransferase (MGMT) mediated resistance. Forty-three patients with a defined clinico-radiological diagnosis of DIPG received radiotherapy and concomitant temozolomide (75 mg/m(2)) after which up to 12 courses of 21d of adjuvant temozolomide (75-100mg/m(2)) were given 4 weekly. The trial used a 2-stage design and passed interim analysis. At diagnosis median age was 8 years (2-20 years), 81% had cranial nerve abnormalities, 76% ataxia and 57% long tract signs. Median Karnofsky/Lansky score was 80 (10-100). Patients received a median of three courses of adjuvant temozolomide, five received all 12 courses and seven did not start adjuvant treatment. Three patients were withdrawn from study treatment due to haematological toxicity and 10 had a dose reduction. No other significant toxicity related to temozolomide was noted. Overall survival (OS) (95% confidence interval (CI)) was 56% (40%, 69%) at 9 months, 35% (21%, 49%) at 1 year and 17% (7%, 30%) at 2 years. Median survival was 9.5 months (range 7.5-11.4 months). There were five 2-year survivors with a median age of 13.6 years at diagnosis. This trial demonstrated no survival benefit of the addition of dose dense temozolomide, to standard radiotherapy in children with classical DIPG. However, a subgroup of adolescent DIPG patients did have a prolonged survival, which needs further exploration.

  11. 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.

  12. Results of a double-blind, randomized trial of ceftobiprole treatment of complicated skin and skin structure infections caused by gram-positive bacteria.

    Science.gov (United States)

    Noel, Gary J; Strauss, Richard S; Amsler, Karen; Heep, Markus; Pypstra, Rienk; Solomkin, Joseph S

    2008-01-01

    Ceftobiprole is the first broad-spectrum cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA) to be assessed in late-stage clinical trials. As a pivotal step in the clinical development of ceftobiprole, a multicenter, global, randomized, double-blind trial was conducted to compare the efficacy of ceftobiprole to that of vancomycin in patients with complicated skin and skin structure infections (cSSSIs) caused by gram-positive bacteria. The primary objective was to assess noninferiority on the basis of the cure rates 7 to 14 days after the completion of therapy in patients administered ceftobiprole 500 mg every 12 h or vancomycin 1 g every 12 h. Of 784 patients randomized, 282 receiving ceftobiprole and 277 receiving vancomycin were clinically evaluable. Of these patients, 93.3% treated with ceftobiprole and 93.5% treated with vancomycin were cured (95% confidence interval of difference, -4.4%, 3.9%). The cure rates for patients with MRSA infections were 91.8% (56/61) with ceftobiprole treatment and 90.0% (54/60) with vancomycin treatment (95% confidence interval of difference, -8.4%, 12.1%). At least one adverse event (AE) was reported by 52% of the ceftobiprole-treated patients and 51% of the vancomycin-treated patients. The most common AEs reported by the ceftobiprole-treated patients were nausea (14%) and taste disturbance (8%). Discontinuation of the study drug because of treatment-emergent AEs occurred in 4% (n = 17) of the ceftobiprole-treated patients and 6% (n = 22) of the vancomycin-treated patients. The results of this trial support the use of ceftobiprole as an effective and well-tolerated treatment option for patients with cSSSIs caused by a spectrum of gram-positive bacteria.

  13. 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

  14. 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.

  15. 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.

  16. Results of a double-blind, placebo-controlled pharmacotherapy trial in alcoholism conducted in Germany and comparison with the US COMBINE study.

    Science.gov (United States)

    Mann, Karl; Lemenager, Tagrid; Hoffmann, Sabine; Reinhard, Iris; Hermann, Derik; Batra, Anil; Berner, Michael; Wodarz, Norbert; Heinz, Andreas; Smolka, Michael N; Zimmermann, Ulrich S; Wellek, Stefan; Kiefer, Falk; Anton, Raymond F

    2013-11-01

    The results of placebo-controlled trials (RCTs) with acamprosate or naltrexone vary substantially. Those differences have been attributed to differing patient characteristics, recruitment strategies, treatment settings and remuneration systems. We tested these assumptions by comparing a new double-blind, placebo-controlled randomized trial conducted in Germany (called PREDICT Study) with data from the US COMBINE Study. PREDICT was designed according to the protocol of the COMBINE Study. A total of 426 alcohol-dependent patients were compared to 459 COMBINE Study patients corresponding to the treatment cells in PREDICT. All patients received acamprosate, naltrexone or placebo for 3 months (PREDICT) or 4 months (COMBINE). Biweekly manualized 'medical management' to enhance compliance was delivered in both studies. Time until the first occurrence of heavy drinking was the main outcome measure. PREDICT found neither acamprosate nor naltrexone to supply any additional benefit compared with placebo, which is at variance with a positive naltrexone effect being reported in the COMBINE Study. A secondary comparison between both studies showed better overall treatment outcomes in PREDICT, although these patients had been more severely affected than their COMBINE counterparts. The divergence in results may be attributable to basic differences in the treatment environments (such as in-patient pre-treatment versus primary outpatient care). We suggest that identically designed RCTs conducted in different parts of the world may help improve the external validity of RCTs. This approach could be called 'comparative efficacy research'.

  17. 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.

  18. A case management intervention targeted to reduce healthcare consumption for frequent Emergency Department visitors: results from an adaptive randomized trial

    OpenAIRE

    2016-01-01

    Background A small group of frequent visitors to Emergency Departments accounts for a disproportionally large fraction of healthcare consumption including unplanned hospitalizations and overall healthcare costs. In response, several case and disease management programs aimed at reducing healthcare consumption in this group have been tested; however, results vary widely. Objectives To investigate whether a telephone-based, nurse-led case management intervention can reduce healthcare consumptio...

  19. Results of a Community Randomized Study of a Faith-Based Education Program to Improve Clinical Trial Participation among African Americans

    Directory of Open Access Journals (Sweden)

    Paula M. Frew

    2015-12-01

    Full Text Available This is a report of a cluster randomized clinical trial evaluating the effectiveness of a church-based educational intervention aimed at improving African Americans’ (AA participation in clinical trials. Two hundred and twenty-one AA subjects ages ≥50 years from six predominantly AA churches were randomized to intervention or control condition. The intervention included three educational sessions about clinical trials and health disparities; control participants completed questionnaires. Primary endpoints of the study were differences in individual subjects' intentions to obtain clinical trial information and intention to join a clinical trial, as determined by 10 point scale items at baseline, three and six months. A statistically significant increase in the intention to obtain clinical trial information at the three and six month time points was observed in the intervention group, but not the control group. Older participants (65–95 years were less likely than younger participants (50–64 years to increase their motivation to seek clinical trial information by the three and six month time points. No significant increases were observed in intention to join clinical trials. This randomized trial shows that AA church-based educational interventions are likely to increase the motivation of AA subjects to obtain clinical trial information and are therefore potentially effective at ameliorating the underrepresentation of AA subjects in clinical trials.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2014-09-25

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

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

    Directory of Open Access Journals (Sweden)

    Gabrail N

    2015-03-01

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

  2. Assessing the feasibility of hepatitis C virus vaccine trials: results from the Hepatitis C Incidence and Transmission Study-community (HITS-c) vaccine preparedness study.

    Science.gov (United States)

    White, Bethany; Madden, Annie; Prins, Maria; Hellard, Margaret; Wand, Handan; Dore, Gregory J; Page, Kimberly; Maher, Lisa

    2014-09-22

    Efficacy trials of preventive hepatitis C virus (HCV) vaccine candidates raise challenging scientific and ethical issues. Based on data from the first 3 years of a community-based prospective observational study - the Hepatitis C Incidence and Transmission Study-community (HITS-c) - this paper examines the feasibility of conducting trials of candidate HCV vaccines with people who inject drugs (PWID) in Sydney, Australia. Of the 166 PWID confirmed HCV antibody negative and eligible for enrolment, 156 (94%) completed baseline procedures. Retention was high, with 89% of participants retained at 48 weeks and 76% of participants completing at least 75% of study visits within 2 weeks of schedule. The rate of primary HCV infection was 7.9/100 py (95% CI 4.9, 12.7). Of the 17 incident cases, 16 completed at least one follow-up assessment and 12 (75%) had evidence of chronic viraemia with progression to chronic HCV infection estimated to be 6/100 py. Power calculations suggest a chronic HCV infection rate of at least 12/100 py (primary HCV infection rate 16/100 py) will be required for stand-alone trials of highly efficacious candidates designed to prevent chronic infection. However, elevated primary HCV infection was observed among participants not receiving opioid substitution therapy who reported heroin as the main drug injected (26.9/100 py, 95% CI 14.5, 50.0) and those who reported unstable housing (23.5/100 py, 95% CI 7.6, 72.8), daily or more frequent injecting (22.7/100 py, 95% CI 12.2, 42.2) and receptive syringe sharing (23.6/100 py, 95% CI 9.8, 56.7) in the 6 months prior to baseline. These data suggest that it is possible to recruit and retain at-risk PWID who adhere to study protocols and that modification of eligibility criteria may identify populations with sufficiently high HCV incidence. Results support the feasibility of large multi-centre HCV vaccine trials, including in the Australian setting.

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

    Directory of Open Access Journals (Sweden)

    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

  4. Evaluation of Commercial Self-Monitoring Devices for Clinical Purposes: Results from the Future Patient Trial, Phase I

    Science.gov (United States)

    Leth, Soren; Hansen, John; Nielsen, Olav W.; Dinesen, Birthe

    2017-01-01

    Commercial self-monitoring devices are becoming increasingly popular, and over the last decade, the use of self-monitoring technology has spread widely in both consumer and medical markets. The purpose of this study was to evaluate five commercially available self-monitoring devices for further testing in clinical applications. Four activity trackers and one sleep tracker were evaluated based on step count validity and heart rate validity. Methods: The study enrolled 22 healthy volunteers in a walking test. Volunteers walked a 100 m track at 2 km/h and 3.5 km/h. Steps were measured by four activity trackers and compared to gyroscope readings. Two trackers were also tested on nine subjects by comparing pulse readings to Holter monitoring. Results: The lowest average systematic error in the walking tests was −0.2%, recorded on the Garmin Vivofit 2 at 3.5 km/h; the highest error was the Fitbit Charge HR at 2 km/h with an error margin of 26.8%. Comparisons of pulse measurements from the Fitbit Charge HR revealed a margin error of −3.42% ± 7.99% compared to the electrocardiogram. The Beddit sleep tracker measured a systematic error of −3.27% ± 4.60%. Conclusion: The measured results revealed the current functionality and limitations of the five self-tracking devices, and point towards a need for future research in this area. PMID:28117736

  5. Cost-effectiveness of internet-based cognitive behavior therapy for irritable bowel syndrome: results from a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    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.

  6. DA-9601 for erosive gastritis:Results of a double-blind placebo-controlled phase Ⅲ clinical trial

    Institute of Scientific and Technical Information of China (English)

    Sang Yong Seol; Myung Hwan Kim; Jong Sun Ryu; Myung Gyu Choi; Dong Wook Shin; Byoung Ok Ahn

    2004-01-01

    AIM: To determine the efficacy and safety of DA-9601 on erosive gastritis versus cetraxate as a standard drug by gastrointestinal endoscopy.METHODS: Five hundred and twelve patients with erosive gastritis were divided into three groups. The groups received 180 mg or 360 mg of DA-9601, or 600 mg of cetraxate (NeuerTM) t.i.d, for 2 wk, respectively. Endoscopic observations were performed before and 2 wk after the treatment, and the cure and improvement rates were investigated.RESULTS: Of the 512 intention-to-treat (ITl) population,457 patients comprised the per protocol (PP) analysis.Endoscopic cure rate was significantly higher in the DA9601 group than in the cetraxate group in both the PP (56%, 58% vs36%; DA-9601 180 mg, 360 mg and cetraxate,respectively) and ITT (52%, 51% vs 35%) populations.Two DA-9601 groups (180 and 360 mg) had significantly higher endoscopic improvement rates than the cetraxate group in both the PP (67%, 65% vs 46%) and ITT (63%,58% vs 45%) populations. The percentage of symptom relief over the 2 wk was found not significantly different between groups. During the study, both DA-9601 and cetraxate produced no treatment-associated adverse events.CONCLUSION: From these results, it appears that DA9601 has excellent efficacy on erosive gastritis. This study also confirms the safety profile of DA-9601.

  7. 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. 

  8. Evaluation of Commercial Self-Monitoring Devices for Clinical Purposes: Results from the Future Patient Trial, Phase I

    Directory of Open Access Journals (Sweden)

    Soren Leth

    2017-01-01

    Full Text Available Commercial self-monitoring devices are becoming increasingly popular, and over the last decade, the use of self-monitoring technology has spread widely in both consumer and medical markets. The purpose of this study was to evaluate five commercially available self-monitoring devices for further testing in clinical applications. Four activity trackers and one sleep tracker were evaluated based on step count validity and heart rate validity. Methods: The study enrolled 22 healthy volunteers in a walking test. Volunteers walked a 100 m track at 2 km/h and 3.5 km/h. Steps were measured by four activity trackers and compared to gyroscope readings. Two trackers were also tested on nine subjects by comparing pulse readings to Holter monitoring. Results: The lowest average systematic error in the walking tests was −0.2%, recorded on the Garmin Vivofit 2 at 3.5 km/h; the highest error was the Fitbit Charge HR at 2 km/h with an error margin of 26.8%. Comparisons of pulse measurements from the Fitbit Charge HR revealed a margin error of −3.42% ± 7.99% compared to the electrocardiogram. The Beddit sleep tracker measured a systematic error of −3.27% ± 4.60%. Conclusion: The measured results revealed the current functionality and limitations of the five self-tracking devices, and point towards a need for future research in this area.

  9. 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

  10. 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; van Cutsem, E; van Laethern, JL; Gress, TM; 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

  11. 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

  12. A Randomized, Double-masked Clinical Trial Comparing Four Periodontitis Treatment Strategies: 5-year Tooth Loss Results

    DEFF Research Database (Denmark)

    Preus, Hans R; Gjermo, Per; Baelum, Vibeke

    2017-01-01

    BACKGROUND: Tooth loss is the ultimate negative consequence of periodontitis, and reports of the extent to which different treatment strategies may influence the loss of teeth in the long run are hard to find. AIM: To test the hypothesis that there is no difference in the 5-year clinical outcome...... of therapy in terms of tooth mortality between groups of patients treated with conventional over-weeks scaling and root planing (SRP) or same-day full-mouth disinfection (FDIS), with or without adjunctive metronidazole. MATERIALS AND METHODS: 184 patients with moderate to severe periodontitis were randomly...... following completion of periodontal therapy, none of the 4 strategies produced a better end result than the other....

  13. Detection of silent myocardial ischemia in asymptomatic patients with diabetes: results of a randomized trial and meta-analysis assessing the effectiveness of systematic screening

    Directory of Open Access Journals (Sweden)

    Penfornis Alfred

    2011-01-01

    Full Text Available Abstract Background Most guidelines recommend a systematic screening of asymptomatic high risk patients with diabetes for silent ischemia, but the clinical benefit of this strategy has not been demonstrated compared with the simple control of cardiovascular risk factors. We sought to determine whether referring asymptomatic diabetic patients for screening of silent ischemia decreases the risk of cardiovascular events compared with usual care. Methods DYNAMIT was a prospective, randomized, open, blinded end-point multicenter trial run between 2000 and 2005, with a 3.5 year mean follow-up in ambulatory care in 45 French hospitals. The study included 631 male and female with diabetes aged 63.9 ± 5.1 years, with no evidence of coronary artery disease and at least 2 additional cardiovascular risk factors, receiving appropriate medical treatment. The patients were randomized centrally to either screening for silent ischemia using a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography (N = 316, or follow-up without screening (N = 315. The main study end point was time to death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention. The results of a meta-analysis of DYNAMIT and DIAD, a similar study, are also presented. Results The study was discontinued prematurely because of difficulties in recruitment and a lower-than expected event rate. Follow-up was complete for 98.9% patients regarding mortality and for 97.5% regarding the main study end point. Silent ischemia detection procedure was positive or uncertain in 68 (21.5% patients of the screening group. There was no significant difference between the screening and the usual care group for the main outcome (hazard ratio = 1.00 95%CI 0.59 to 1.71. The meta-analysis of these and DIAD results gave similar results, with narrower confidence intervals for each endpoint. Conclusions These

  14. 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.

  15. 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.

  16. 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.

  17. Robotic right colectomy: A worthwhile procedure? Results of a meta-analysis of trials comparing robotic versus laparoscopic right colectomy

    Directory of Open Access Journals (Sweden)

    Niccolή Petrucciani

    2015-01-01

    Full Text Available Background: Robotic right colectomy (RRC is a complex procedure, offered to selected patients at institutions highly experienced with the procedure. It is still not clear if this approach is worthwhile in enhancing patient recovery and reducing post-operative complications, compared with laparoscopic right colectomy (LRC. Literature is still fragmented and no meta-analyses have been conducted to compare the two procedures. This work aims at reducing this gap in literature, in order to draw some preliminary conclusions on the differences and similarities between RRC and LRC, focusing on short-term outcomes. Materials and Methods: A systematic literature review was conducted to identify studies comparing RRC and LRC, and meta-analysis was performed using a random-effects model. Peri-operative outcomes (e.g., morbidity, mortality, anastomotic leakage rates, blood loss, operative time constituted the study end points. Results: Six studies, including 168 patients undergoing RRC and 348 patients undergoing LRC were considered as suitable. The patients in the two groups were similar with respect to sex, body mass index, presence of malignant disease, previous abdominal surgery, and different with respect to age and American Society of Anesthesiologists score. There were no statistically significant differences between RRC and LRC regarding estimated blood loss, rate of conversion to open surgery, number of retrieved lymph nodes, development of anastomotic leakage and other complications, overall morbidity, rates of reoperation, overall mortality, hospital stays. RRC resulted in significantly longer operative time. Conclusions: The RRC procedure is feasible, safe, and effective in selected patients. However, operative times are longer comparing to LRC and no advantages in peri-operative and post-operative outcomes are demonstrated with the use of the robotic surgical system.

  18. 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

  19. 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.

  20. 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.

  1. Eliglustat, an investigational oral therapy for Gaucher disease type 1: Phase 2 trial results after 4 years of treatment.

    Science.gov (United States)

    Lukina, Elena; Watman, Nora; Dragosky, Marta; Pastores, Gregory M; Arreguin, Elsa Avila; Rosenbaum, Hanna; Zimran, Ari; Angell, Jennifer; Ross, Leorah; Puga, Ana Cristina; Peterschmitt, Judith M

    2014-12-01

    Eliglustat is an investigational, oral substrate reduction therapy for Gaucher disease type 1 (GD1). Nineteen treatment-naïve patients have now completed 4years of an open-label study (NCT00358150). Mean hemoglobin level and platelet count increased by 2.3±1.5g/dL (baseline: 11.3±1.5g/dL) and 95% (baseline: 68,700±21,200/mm(3)), respectively. Mean spleen and liver volumes (multiples of normal, MN) decreased by 63% (baseline: 17.3±9.5 MN) and 28% (baseline: 1.7±0.4 MN), respectively. Median chitotriosidase and CCL-18 each decreased by 82%; plasma glucosylceramide and GM3 normalized. Mean bone mineral density T-score for the lumbar spine increased by 0.8 (60%) (baseline: -1.6±1.1). Femur dark marrow, a reflection of Gaucher cell infiltration into bone marrow, was reduced or stable in 17/18 patients. There were no bone crises. Most adverse events were mild and unrelated to treatment. These results extend the safety and efficacy of eliglustat reported at 1 and 2 years to 4 years.

  2. Oral immune regulation using colitis extracted proteins for treatment of Crohn's disease: Results of a phase Ⅰ clinical trial

    Institute of Scientific and Technical Information of China (English)

    Eran Israeli; Eran Goldin; Oren Shibolet; Athalia Klein; Nilla Hemed; Dean Engelhardt; Elazar Rabbani; Yaron Ilan

    2005-01-01

    AIM: To evaluate safety and possible efficacy of induction of oral immune regulation using colitis extracted proteins (CEP) in Crohn's disease (CD) subjects. METHODS: Ten CDs were treated orally with autologous CEP thrice weekly for 16 wk. Subjects were monitored for CDAI and IBDQ. Immune modulatory effect was assessed by T-lymphocyte FACS analysis, CEP-specific IFNγ ELISPOT assay and cytokine levels. RESULTS: Induction of oral immune regulation significantly ameliorated disease activity. All (10/10) subjects had clinical response (CDAI ≤ 70) and 7/10 achieved clinical remission (CDAI ≤ 150). Significant increase in mean IBDQ score was noted (134±9 vs 164±12). No treatment-related adverse events were noted. High levels of CEP-specific IFNγ spot forming colonies were detected in five subjects prior to treatment and in all five, a marked decrease was observed. The CD4+/CD8+ lymphocyte ratio and peripheral NKT cell numbers increased significantly, in 7/10 and in 5/10 subjects, respectively. Significant increase in serum IL-10 and IL-4 levels was observed in 7/10 subjects during treatment period.CONCLUSION: Immune regulation via oral administration of CEP is a safe and possibly effective treatment for subjects with moderate CD and may provide means of antigen-specific immune modulation.

  3. 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.

  4. 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.

  5. White pine blister rust resistance in North American, Asian and European species - results from artificial inoculation trials in Oregon

    Directory of Open Access Journals (Sweden)

    R.A. Sniezko

    2008-09-01

    Full Text Available Dorena Genetic Resource Center (DGRC has used artificial inoculationtrials to evaluate progenies of thousands of Pinus monticola and P. lambertiana selections from Oregon and Washington for resistance to white pine blister rust caused by Cronartium ribicola. In addition, early results are now available for P.albicaulis and P. strobiformis. DGRC has also recently evaluated seed orchard progenies of P.strobus, as well as bulked seedlots from P. armandii and P. peuce.The majority of P. monticola, P. lambertiana, P. albicaulis, and P. strobus progenies are very susceptible to blister rust. However, resistance exists in all these species. P.strobiformis showed relatively high levels of resistance for the eight progenies tested.Resistance in P. armandii was mainly reflected in the very low percentage of cankered seedlings; for P. peuce, the high percentage of cankered seedlings alive three years after inoculation was notable. R-genes are present in some of the North American five-needle pine species, but partial resistance traits (e.g. bark reactionwill play a major role in breeding activities for P. monticola and P. lambertiana and will likely be the key to developing durable resistance.

  6. 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

  7. 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...

  8. 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

  9. 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.

  10. Personality and Personality Disorders in Urban and Rural Africa: Results from a Field Trial in Burkina Faso

    Directory of Open Access Journals (Sweden)

    Jérôme eRossier

    2013-03-01

    Full Text Available Several studies have observed that the structure underlying both normal personality and personality disorders is stable across cultures. Most of this cross-cultural research was conducted in Western and Asian cultures. In Africa, the few studies were conducted with well-educated participants using French or English instruments. No research was conducted in Africa with less privileged or preliterate samples. The aim of this research was to study the structure and expression of normal and abnormal personality in an urban and a rural sample in Burkina Faso. The sample included 1750 participants, with a sub-sample from the urban area of Ouagadougou (n = 1249 and another sub-sample from a rural village, Soumiaga (n = 501. Most participants answered an interview consisting of a Mooré language adaptation of the Revised NEO Personality Inventory and of the International Personality Disorders Examination. A sub-sample completed the same instruments in French. Demographic variables only have a small impact on normal and abnormal personality traits. The structure underlying normal personality was unstable across regions and languages, illustrating that translating a complex psychological inventory into a native African language is a very difficult task. The structure underlying abnormal personality was stable across regions, scales reaching even metric equivalence. As scalar equivalence was not reached, mean differences cannot be interpreted. Nevertheless, these differences could be due to an exaggerated expression of abnormal traits valued in the two cultural settings. Our results suggest that studies using a different methodology should be conducted to understand what is considered, in different cultures, as deviating from the expectations of the individual’s culture, and as a significant impairment in self and interpersonal functioning, as defined by the DSM-5.

  11. 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.

  12. The influence of wearing schemes and supportive telephone calls on adherence in accelerometry measurement: results of a randomized controlled trial

    Science.gov (United States)

    van den Berg, Neeltje; Ulbricht, Sabina; Schwaneberg, Thea; Weitmann, Kerstin; Weymar, Franziska; Groß, Stefan; Dörr, Marcus; Hoffmann, Wolfgang

    2017-01-01

    Background Physical activity (PA) can be assessed by accelerometer monitors. However, a high adherence to wearing this device is essential to obtain valid data. In this study, the influence of different wearing schemes and additional supportive phone calls (SPCs) on adherence was examined. Methods A randomized study with four groups was conducted in the context of a health examination program among participants aged 40–75 years without a history of cardiovascular diseases. Participants were recruited in different settings (general medical practices, job center, and health insurance). The participants were asked to wear an accelerometer for 7 consecutive days according to the wearing scheme “day and night” or “day only” and received or did not receive SPCs. Full adherence was defined as a total wearing time of 98 hours (between 8 am and 10 pm during 7 days). A generalized linear model was used to calculate the difference between the maximum possible and the observed adherence. Results Adherence could be assessed for 249 participants (mean age: 56.40 years; standard deviation [SD] 9.83, 40% males). The mean wearing time was 84.04 hours (SD 20.75). Participants with the wearing scheme day and night were significantly more adherent than participants with the wearing scheme day only (incidence rate ratio [IRR] 0.63; P=0.005). SPCs had no additional effect on adherence (IRR 0.80; P=0.168). Conclusion To assess PA, the wearing scheme day and night provides the best possible adherence in this group of participants. Further studies are necessary to examine adherence and the effects of additional SPCs in other samples or settings.

  13. 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.

  14. 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

  15. 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;}

  16. 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

  17. Efficacy and Safety of Epratuzumab in Moderately to Severely Active Systemic Lupus Erythematosus: Results From Two Phase III Randomized, Double‐Blind, Placebo‐Controlled Trials

    Science.gov (United States)

    Wallace, Daniel J.; Furie, Richard A.; Petri, Michelle A.; Pike, Marilyn C.; Leszczyński, Piotr; Neuwelt, C. Michael; Hobbs, Kathryn; Keiserman, Mauro; Duca, Liliana; Kalunian, Kenneth C.; Galateanu, Catrinel; Bongardt, Sabine; Stach, Christian; Beaudot, Carolyn; Kilgallen, Brian; Gordon, Caroline; Batalov, A.; Bojinca, M.; Djerassi, R.; Duca, L.; Horak, P.; Kolarov, Z.; Milasiene, R.; Monova, D.; Otsa, K.; Pileckyte, M.; Popova, T.; Radulescu, F.; Rashkov, R.; Rednic, S.; Repin, M.; Stoilov, R.; Tegzova, D.; Vezikova, N.; Vitek, P.; Zainea, C.; East, Far; Baek, H.; Chen, Y.; Chiu, Y.; Cho, C.; Chou, C.; Choe, J.; Huang, C.; Kang, Y.; Kang, S.; Lai, N.; Lee, S.; Park, W.; Shim, S.; Suh, C.; Yoo, W.; Armengol, H. Avila; Zapata, F. Avila; Santiago, M. Barreto; Cavalcanti, F.; Chahade, W.; Costallat, L.; Keiserman, M.; Alcala, J. Orozco; Remus, C. Ramos; Roimicher, L.; Abu‐Shakra, M.; Agarwal, V.; Agmon‐Levin, N.; Kadel, J.; Levy, Y.; Mevorach, D.; Paran, D.; Reitblat, T.; Rosner, I.; Shobha, V.; Sthoeger, Z.; Zisman, D.; Ayesu, K.; Berney, S.; Box, J.; Busch, H.; Buyon, J.; Carter, J.; Chi, J.; Clowse, M.; Collins, R.; Dao, K.; Diab, I.; Dikranian, A.; El‐Shahawy, M.; Gaylis, N.; Grossman, J.; Halpert, E.; Huff, J.; Jarjour, W.; Kao, A.; Katz, R.; Kennedy, A.; Khan, M.; Kivitz, A.; Kohen, M.; Lawrence‐Ford, T.; Lawson, J.; Levesque, M.; Lowenstein, M.; Majjhoo, A.; Mcarthur, R.; McLain, D.; Merrill, J.; Murillo, A.; Neucks, S.; Niemer, G.; Noaiseh, G.; Parker, C.; Pantojas, C.; Pattanaik, D.; Petri, M.; Pickrell, P.; Reveille, J.; Roman‐Miranda, A.; Rothfield, N.; Sankoorikal, A.; Sayers, M.; Singhal, A.; Snyder, A.; Striebich, C.; Vo, Q.; von Feldt, J.; Wallace, D.; Wasko, M.; Young, C.; Adelstein, S.; Hall, S.; Littlejohn, G.; Nicholls, D.; Suranyi, M.; Amoura, Z.; Bannert, B.; Behrens, F.; Perez, L.Carreno; Chakravarty, K.; Gonzales, F. Diaz; Davies, K.; Doria, A.; Emery, P.; Fernández‐Nebro, A.; Govoni, M.; Hachulla, E.; Hellmich, B.; Houssiau, F.; Malaise, M.; Margaux, J.; Maugars, Y.; Muñoz‐Fernández, S.; Navarro, F.; Ordi‐Ros, J.; Pellerito, R.; Pena‐Sagredo, J.; Roussou, E.; Schmidt, R. E.; Ucar‐Angulo, E.; Viallard, J‐F.; Westhovens, R.; Worm, M.; Yee, C. S.; Nayiager, S.; Reuter, H.; Spargo, C.; Bazela, B.; Brzosko, M.; Chudzik, D.; Gasztonyi, B.; Geher, P.; Ionescu, R.; Jeka, S.; Kemeny, L.; Kiss, E.; Kotyla, P.; Kovacs, L.; Kovalenko, V.; Kucharz, E.; Kwiatkowska, B.; Leszczynski, P.; Levchenko, E.; Lysenko, G.; Majdan, M.; Mihailov, C.; Nalotov, S.; Nedelciu, M.; Pavel, M.; Raskina, T.; Rebrov, B.; Rezus, E.; Semen, T.; Smakotina, S.; Stanislavchuk, M.; Stanislav, M.; Szombati, I.; Szucs, G.; Udrea, G.; Zajdel, J.; Zon‐Giebel, A.; Bonfiglioli, R.; Bustamante, R.; Klumb, E.; Ramirez, G. Medrano; Neiva, C.; Olguin, M.; Gonzaga, J.Reyes; Scotton, A.; Ayala, S. Sicsik; Ximenes, A.; Sharma, R.; Srikantiah, C.; Aelion, J.; Aranow, C.; Baker, M.; Chadha, A.; Chao, J.; Chatham, W.; Chow, A.; Clay, C.; Cohen‐Gadol, S.; Conaway, D.; Denburg, J.; Escalante, A.; Espinoza, L.; Fiechtner, J.; Fortin, I.; Fraser, A.; Furie, R.; Gladman, D.; Goddard, D.; Goldberg, M.; Gonzalez‐Rivera, R.; Gorman, J.; Griffin, R.; Haaland, D.; Halter, D.; Hemaiden, A.; Hobbs, K.; Joshi, V.; Lim, S.; Kalunian, K.; Karpouzas, G.; Khraishi, M.; Lafyatis, R.; Lee, S.; Lidman, R.; Lue, C.; Mohan, M.; Mease, P.; Mehta, C.; Mizutani, W.; Nami, A.; Nascimento, J.; Neuwelt, C.; Pappas, J.; Pope, J.; Porges, A.; Roane, G.; Rosenberg, D.; Ross, S.; Saadeh, C.; Scoville, C.; Sherrer, Y.; Solomon, M.; Surbeck, W.; Valenzuela, G.; Waller, P.; Alten, R.; Baerwald, C.; Bienvenu, B.; Bombardieri, S.; Braun, J.; Dival, L.; Espinosa, G.; Fernandez, I. Figueroa; Gomez‐Reino, J.; Gordon, C.; Hiepe, F.; Hopkinson, N.; Isenberg, D.; Jacobi, A.; Jorgensen, C.; Guern, V. Le; Paul, C.; Pego‐Reigosa, J. M.; Heredia, J. Rodriguez; Rubbert‐Roth, A.; Sabbadini, M.; Schroeder, J.; Schwarting, A.; Spieler, W.; Valesini, G.; Wollenhaupt, J.; Mendoza, A. Zea; Zouboulis, C.

    2017-01-01

    Objective Epratuzumab, a monoclonal antibody that targets CD22, modulates B cell signaling without substantial reductions in the number of B cells. The aim of this study was to report the results of 2 phase III multicenter randomized, double‐blind, placebo‐controlled trials, the EMBODY 1 and EMBODY 2 trials, assessing the efficacy and safety of epratuzumab in patients with moderately to severely active systemic lupus erythematosus (SLE). Methods Patients met ≥4 of the American College of Rheumatology revised classification criteria for SLE, were positive for antinuclear antibodies and/or anti–double‐stranded DNA antibodies, had an SLE Disease Activity Index 2000 (SLEDAI‐2K) score of ≥6 (increased disease activity), had British Isles Lupus Assessment Group 2004 index (BILAG‐2004) scores of grade A (severe disease activity) in ≥1 body system or grade B (moderate disease activity) in ≥2 body systems (in the mucocutaneous, musculoskeletal, or cardiorespiratory domains), and were receiving standard therapy, including mandatory treatment with corticosteroids (5–60 mg/day). BILAG‐2004 grade A scores in the renal and central nervous system domains were excluded. Patients were randomized 1:1:1 to receive either placebo, epratuzumab 600 mg every week, or epratuzumab 1,200 mg every other week, with infusions delivered for the first 4 weeks of each 12‐week dosing cycle, for 4 cycles. Patients across all 3 treatment groups also continued with their standard therapy. The primary end point was the response rate at week 48 according to the BILAG‐based Combined Lupus Assessment (BICLA) definition, requiring improvement in the BILAG‐2004 score, no worsening in the BILAG‐2004 score, SLEDAI‐2K score, or physician's global assessment of disease activity, and no disallowed changes in concomitant medications. Patients who discontinued the study medication were classified as nonresponders. Results In the EMBODY 1 and EMBODY 2 trials of epratuzumab, 793

  18. 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

  19. 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

    -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...... was more extensive on 18F2 PET/CT and 18F2/18F-FDG PET/CT than on 18F-FDG PET/CT. In another 29 participants, 18F2 PET/CT and 18F2/18F-FDG PET/CT showed osseous metastases where 18FFDG PET/CT was negative. The extent of skeletal lesions was similar in 18 participants on all 3 scans. Conclusion: This trial...

  20. 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.

  1. Preliminary results from multicenter clinical trials for detection of cervical squamous intraepithelial lesions using a novel full-field evoked-tissue-flourescence-based imaging instrument

    Science.gov (United States)

    Dattamajumdar, Anupam K.; Wells, D.; Parnell, Julie R.; Ganguly, Dipankur; Wright, Thomas C., Jr.

    2001-10-01

    We report preliminary results from a multi-center trial of evaluating the performance of a novel, full-field multi-spectral tissue fluorescence imaging system (CerviscanTM) designed to detect cervical squamous intraepithelial lesions. Spectral data from multiple regions of 48 patients enrolled from clinical performance sites in the US and Canada are included in this preliminary analysis. This includes 30 women used for the training set and 18 used for the testing set. In the testing set, 37/43 SIL and 70/80 NonSIL regions were correctly identified for a sensitivity of 86% and specificity of 87.5%. CerviscanTM locates cervical precancerous lesions with high sensitivity and specificity and has the potential to permit 'see and treat' patient management.

  2. 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.

  3. Changes in the vitamin D endocrine system and bone turnover after oral vitamin D3 supplementation in healthy adults: results of a randomised trial

    Directory of Open Access Journals (Sweden)

    Holvik Kristin

    2012-06-01

    Full Text Available Abstract Background There is uncertainty as to which intake of vitamin D is needed to suppress PTH and maintain normal bone metabolism throughout winter at northern latitudes. We aimed to investigate whether four weeks’ daily supplementation with 10 μg vitamin D3 from fish oil produced a greater change in serum vitamin D metabolites, parathyroid hormone, and bone turnover in healthy adults compared with solid multivitamin tablets. Furthermore, it was studied whether age, gender, ethnic background, body mass index, or serum concentrations at baseline predicted the magnitude of change in these parameters. Methods Healthy adults aged 19–48 years living in Oslo, Norway (59°N were randomised to receive a daily dose of 10 μg vitamin D3 given as fish oil capsules or multivitamin tablets during four weeks in late winter. Serum samples from baseline and after 28 days were analysed for 25-hydroxyvitamin D (s-25(OHD, 1,25-dihydroxyvitamin D (s-1,25(OH2D, intact parathyroid hormone (s-iPTH, and osteoclast-specific tartrate-resistant acid phosphatase 5b (s-TRACP. Fifty-five eligible participants completed the intervention (74% of those randomised. Results S-25(OHD increased by mean 34.1 (SD 13.1 nmol/l, p 2D increased by mean 13 (SD 48 pmol/l, p = 0.057; and s-TRACP increased by mean 0.38 (SD 0.33 U/l, p  Conclusions Four weeks of daily supplementation with 10 μg vitamin D3 decreased mean s-iPTH and increased s-TRACP concentration, and this did not differ by mode of administration. Our results suggest an increased bone resorption following vitamin D supplementation in young individuals, despite a decrease in parathyroid hormone levels. Trial Registration ClinicalTrials.gov: NCT01482689

  4. Cost-effectiveness of an exercise program during pregnancy to prevent gestational diabetes: Results of an economic evaluation alongside a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Oostdam Nicolette

    2012-07-01

    Full Text Available Abstract Background The prevalence of gestational diabetes mellitus (GDM is increasing worldwide. GDM and the risks associated with GDM lead to increased health care costs and losses in productivity. The objective of this study is to evaluate whether the FitFor2 exercise program during pregnancy is cost-effective from a societal perspective as compared to standard care. Methods A randomised controlled trial (RCT and simultaneous economic evaluation of the FitFor2 program were conducted. Pregnant women at risk for GDM were randomised to an exercise program to prevent high maternal blood glucose (n = 62 or to standard care (n = 59. The exercise program consisted of two sessions of aerobic and strengthening exercises per week. Clinical outcome measures were maternal fasting blood glucose levels, insulin sensitivity and infant birth weight. Quality of life was measured using the EuroQol 5-D and quality-adjusted life-years (QALYs were calculated. Resource utilization and sick leave data were collected by questionnaires. Data were analysed according to the intention-to-treat principle. Missing data were imputed using multiple imputations. Bootstrapping techniques estimated the uncertainty surrounding the cost differences and incremental cost-effectiveness ratios. Results There were no statistically significant differences in any outcome measure. During pregnancy, total health care costs and costs of productivity losses were statistically non-significant (mean difference €1308; 95%CI €-229 - €3204. The cost-effectiveness analyses showed that the exercise program was not cost-effective in comparison to the control group for blood glucose levels, insulin sensitivity, infant birth weight or QALYs. Conclusion The twice-weekly exercise program for pregnant women at risk for GDM evaluated in the present study was not cost-effective compared to standard care. Based on these results, implementation of this exercise program for the prevention of

  5. Weight, physical activity and dietary behavior change in young mothers: short term results of the HeLP-her cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Jolley Damien

    2009-05-01

    Full Text Available Abstract Background Preventing weight gain rather than treating established obesity is an important economic and public health response to the rapidly increasing rates of obesity worldwide. Treatment of established obesity is complex and costly requiring multiple resources. Preventing weight gain potentially requires fewer resources to reach broad population groups, yet there is little evidence for successful interventions to prevent weight gain in the community. Women with children are an important target group because of high rates of weight gain and the potential to influence the health behaviors in family members. Methods The aim of this cluster randomized controlled trial was to evaluate the short term effect of a community-based self-management intervention to prevent weight gain. Two hundred and fifty mothers of young children (mean age 40 years ± 4.5, BMI 27.9 kg/m2 ± 5.6 were recruited from the community in Melbourne, Australia. The intervention group (n = 127 attended four interactive group sessions over 4 months, held in 12 local primary schools in 2006, and was compared to a group (n = 123 receiving a single, non-interactive, health education session. Data collection included self-reported weight (both groups, measured weight (intervention only, self-efficacy, dietary intake and physical activity. Results Mean measured weight decreased significantly in the intervention group (-0.78 kg 95% CI; -1.22 to -0.34, p Conclusion Both a single health education session and interactive behavioral intervention will result in a similar weight loss in the short term, although more participants in the interactive intervention lost or maintained weight. There were small non-significant changes to physical activity and changes to fat intake specifically replacing high fat foods with low fat alternatives such as fruit and vegetables. Self-monitoring appears to enhance weight loss when part of an intervention. Trial registration ACTRN12608000110381

  6. The long-term effects of naprapathic manual therapy on back and neck pain - Results from a pragmatic randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bohman Tony

    2010-02-01

    Full Text Available Abstract Background Back and neck pain are very common, disabling and recurrent disorders in the general population and the knowledge of long-term effect of treatments are sparse. The aim of this study was to compare the long-term effects (up to one year of naprapathic manual therapy and evidence-based advice on staying active regarding non-specific back and/or neck pain. Naprapathy, a health profession mainly practiced in Sweden, Finland, Norway and in the USA, is characterized by a combination of manual musculoskeletal manipulations, aiming to decrease pain and disability in the neuromusculoskeletal system. Methods Subjects with non-specific pain/disability in the back and/or neck lasting for at least two weeks (n = 409, recruited at public companies in Sweden, were included in this pragmatic randomized controlled trial. The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization, massage and stretching, (Index Group, and advice to stay active and on how to cope with pain, provided by a physician (Control Group. Pain intensity, disability and health status were measured by questionnaires. Results 89% completed the 26-week follow-up and 85% the 52-week follow-up. A higher proportion in the Index Group had a clinically important decrease in pain (risk difference (RD = 21%, 95% CI: 10-30 and disability (RD = 11%, 95% CI: 4-22 at 26-week, as well as at 52-week follow-ups (pain: RD = 17%, 95% CI: 7-27 and disability: RD = 17%, 95% CI: 5-28. The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy (p ≤ 0.005. There were also significant differences in improvement in bodily pain and social function (subscales of SF-36 health status favoring the Index Group. Conclusions Combined manual therapy, like naprapathy, is effective in the short and in the long term, and might be considered for patients with non-specific back and/or neck

  7. A cluster randomized trial to assess the effect of clinical pathways for patients with stroke: results of the clinical pathways for effective and appropriate care study

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    Panella Massimiliano

    2012-07-01

    Full Text Available Abstract Background Clinical pathways (CPs are used to improve the outcomes of acute stroke, but their use in stroke care is questionable, because the evidence on their effectiveness is still inconclusive. The objective of this study was to evaluate whether CPs improve the outcomes and the quality of care provided to patients after acute ischemic stroke. Methods This was a multicentre cluster-randomized trial, in which 14 hospitals were randomized to the CP arm or to the non intervention/usual care (UC arm. Healthcare workers in the CP arm received 3 days of training in quality improvement of CPs and in use of a standardized package including information on evidence-based key interventions and indicators. Healthcare workers in the usual-care arm followed their standard procedures. The teams in the CP arm developed their CPs over a 6-month period. The primary end point was mortality. Secondary end points were: use of diagnostic and therapeutic procedures, implementation of organized care, length of stay, re-admission and institutionalization rates after discharge, dependency levels, and complication rates. Results Compared with the patients in the UC arm, the patients in the CP arm had a significantly lower risk of mortality at 7 days (OR = 0.10; 95% CI 0.01 to 0.95 and significantly lower rates of adverse functional outcomes, expressed as the odds of not returning to pre-stroke functioning in their daily life (OR = 0.42; 95 CI 0.18 to 0.98. There was no significant effect on 30-day mortality. Compared with the UC arm, the hospital diagnostic and therapeutic procedures were performed more appropriately in the CP arm, and the evidence-based key interventions and organized care were more applied in the CP arm. Conclusions CPs can significantly improve the outcomes of patients with ischemic patients with stroke, indicating better application of evidence-based key interventions and of diagnostic and therapeutic procedures. This study tested a new

  8. 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

  9. 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

  10. 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

  11. Can community retail pharmacist and diabetes expert support facilitate insulin initiation by family physicians? Results of the AIM@GP randomized controlled trial

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    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

  12. Screening and Brief Interventions for Hazardous and Harmful Alcohol Use among University Students in South Africa: Results from a Randomized Controlled Trial

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    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.

  13. Mortality in members of HIV-1 serodiscordant couples in Africa and implications for antiretroviral therapy initiation: Results of analyses from a multicenter randomized trial

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    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

  14. 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

  15. Use of procalcitonin for the diagnosis of pneumonia in patients presenting with a chief complaint of dyspnoea: results from the BACH (Biomarkers in Acute Heart Failure) trial

    Science.gov (United States)

    Maisel, Alan; Neath, Sean-Xavier; Landsberg, Judd; Mueller, Christian; Nowak, Richard M.; Peacock, W. Frank; Ponikowski, Piotr; Möckel, Martin; Hogan, Christopher; Wu, Alan H.B.; Richards, Mark; Clopton, Paul; Filippatos, Gerasimos S.; Di Somma, Salvatore; Anand, Inder; Ng, Leong L.; Daniels, Lori B.; Christenson, Robert H.; Potocki, Mihael; McCord, James; Terracciano, Garret; Hartmann, Oliver; Bergmann, Andreas; Morgenthaler, Nils G.; Anker, Stefan D.

    2012-01-01

    Aims Biomarkers have proven their ability in the evaluation of cardiopulmonary diseases. We investigated the utility of concentrations of the biomarker procalcitonin (PCT) alone and with clinical variables for the diagnosis of pneumonia in patients presenting to emergency departments (EDs) with a chief complaint of shortness of breath. Methods and results The BACH trial was a prospective, international, study of 1641 patients presenting to EDs with dyspnoea. Blood samples were analysed for PCT and other biomarkers. Relevant clinical data were also captured. Patient outcomes were assessed at 90 days. The diagnosis of pneumonia was made using strictly validated guidelines. A model using PCT was more accurate [area under the curve (AUC) 72.3%] than any other individual clinical variable for the diagnosis of pneumonia in all patients, in those with obstructive lung disease, and in those with acute heart failure (AHF). Combining physician estimates of the probability of pneumonia with PCT values increased the accuracy to >86% for the diagnosis of pneumonia in all patients. Patients with a diagnosis of AHF and an elevated PCT concentration (>0.21 ng/mL) had a worse outcome if not treated with antibiotics (P = 0.046), while patients with low PCT values (<0.05 ng/mL) had a better outcome if they did not receive antibiotic therapy (P = 0.049). Conclusion Procalcitonin may aid in the diagnosis of pneumonia, particularly in cases with high diagnostic uncertainty. Importantly, PCT may aid in the decision to administer antibiotic therapy to patients presenting with AHF in which clinical uncertainty exists regarding a superimposed bacterial infection. Trial registration: NCT00537628 PMID:22302662

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

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    Sandra Boy

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

  17. 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

  18. Efficacy and safety of betahistine treatment in patients with Meniere’s disease: primary results of a long term, multicentre, double blind, randomised, placebo controlled, dose defining trial (BEMED trial)

    Science.gov (United States)

    Adrion, Christine; Fischer, Carolin Simone; Wagner, Judith; Gürkov, Robert; Mansmann, Ulrich

    2016-01-01

    Study question What is the long term efficacy of betahistine dihydrochloride on the incidence of vertigo attacks in patients with Meniere’s disease, compared with placebo? Methods The BEMED trial is a multicentre, double blind, randomised, placebo controlled, three arm, parallel group, phase III, dose defining superiority trial conducted in 14 German tertiary referral centres (for neurology or ear, nose, and throat). Adults aged 21-80 years (mean age 56 years) with definite unilateral or bilateral Meniere’s disease were recruited from March 2008 to November 2012. Participants received placebo (n=74), low dose betahistine (2×24 mg daily, (n=73)), or high dose betahistine (3×48 mg daily, (n=74)) over nine months. The primary outcome was the number of attacks per 30 days, based on patients’ diaries during a three month assessment period at months seven to nine. An internet based randomisation schedule performed a concealed 1:1:1 allocation, stratified by study site. Secondary outcomes included the duration and severity of attacks, change in quality of life scores, and several observer-reported parameters to assess changes in audiological and vestibular function. Study answer and limitations Incidence of attacks related to Meniere’s disease did not differ between the three treatment groups (P=0.759). Compared with placebo, attack rate ratios were 1.036 (95% confidence interval 0.942 to 1.140) and 1.012 (0.919 to 1.114) for low dose and high dose betahistine, respectively. The overall monthly attack rate fell significantly by the factor 0.758 (0.705 to 0.816; Pbetahistine, and high dose betahistine groups, respectively. Results were consistent for all secondary outcomes. Treatment was well tolerated with no unexpected safety findings. Without a control group of patients who did not receive any intervention to follow the natural course of the disease, the placebo effect could not be accurately assessed and differentiated from spontaneous remission and

  19. 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.

  20. Co-occurring amphetamine use and associated medical and psychiatric comorbidity among opioid-dependent adults: results from the Clinical Trials Network

    Directory of Open Access Journals (Sweden)

    Blazer DG

    2011-07-01

    Full Text Available Daniel J Pilowsky1, Li-Tzy Wu2, Bruce Burchett2, Dan G Blazer2, George E Woody3, Walter Ling41Departments of Epidemiology and Psychiatry, Columbia University, and the New York State Psychiatric Institute, New York City, NY; 2Department of Psychiatry and Behavioral Sciences, School of Medicine, Duke University Medical Center, Durham, NC; 3Department of Psychiatry, School of Medicine, University of Pennsylvania and Treatment Research Institute, Philadelphia, PA; 4David Geffen School of Medicine, NPI/Integrated Substance Abuse Programs, University of California, Los Angeles, CA, USABackground: In response to the rising rate of treatment admissions related to illicit use of amphetamines (eg, methamphetamine, we examined the prevalence of amphetamine use among treatment-seeking, opioid-dependent adults, explored whether amphetamine users were as likely as nonamphetamine users to enroll in opioid-dependence treatment trials, and determined whether amphetamine users manifested greater levels of medical and psychiatric comorbidity than nonusers.Methods: The sample included 1257 opioid-dependent adults screened for participation in threemultisite studies of the National Drug Abuse Treatment Clinical Trials Network (CTN001-003, which studied the effectiveness of buprenorphine for opioid detoxification under varying treatment conditions. Patients were recruited from 23 addiction treatment programs across the US. Medical and psychiatric comorbidity were examined by past-month amphetamine use (current vs former and route of administration. Five mutually exclusive groups were examined, ie, nonusers, current amphetamine injectors, current amphetamine noninjectors, former amphetamine injectors, and former amphetamine noninjectors.Results: Of the sample (n = 1257, 22.3% had a history of regular amphetamine use. Of the 280 amphetamine users, 30.3% reported injection as their primary route. Amphetamine users were more likely than nonusers to be white and use more

  1. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme.

    Science.gov (United States)

    Yu, M; Van Brunt, K; Varnado, O J; Boye, K S

    2016-04-01

    We evaluated patient-reported outcome (PRO) measures from the Assessment of Weekly AdministRation of LY2189265 (dulaglutide) in Diabetes (AWARD) clinical trial programme for dulaglutide (1.5 mg and 0.75 mg) in patients with type 2 diabetes (T2D). The Impact of Weight on Self-Perception (IW-SP), Impact of Weight on Ability to Perform Physical Activities of Daily Living (APPADL), Impact of Weight on Quality of Life-Lite, EQ-5D, Diabetes Treatment Satisfaction Questionnaire (DTSQ), Diabetes Symptom Checklist-Revised and Adult Low Blood Sugar Survey were administered and analysed for changes from baseline in one or more AWARD studies. Significant within-group changes from baseline to the primary time point were observed for several PRO measures across all studies. Compared with insulin glargine, significantly greater improvements in the IW-SP score were observed with dulaglutide 1.5 mg and with both dulaglutide doses in the APPADL score. Both dulaglutide doses resulted in significantly greater improvement in DTSQ scores (all subscales) compared with exenatide. Dulaglutide 1.5 mg also resulted in significantly greater improvement on the DTSQ hyperglycaemia subscale compared with metformin. Overall, these PRO results suggest that dulaglutide is beneficial in the treatment of T2D.

  2. Randomized Noninferiority Trial of Reduced High-Dose Volume Versus Standard Volume Radiation Therapy for Muscle-Invasive Bladder Cancer: Results of the BC2001 Trial (CRUK/01/004)

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    Huddart, Robert A., E-mail: robert.huddart@icr.ac.uk [Institute of Cancer Research, Royal Marsden NHSFT (National Health Service Foundation Trust) (United Kingdom); Hall, Emma [Institute of Cancer Research (United Kingdom); Hussain, Syed A. [University of Liverpool (United Kingdom); Jenkins, Peter [Gloucestershire Hospitals NHSFT (United Kingdom); Rawlings, Christine [South Devon Healthcare NHSFT (United Kingdom); Tremlett, Jean [Brighton and Sussex University Hospitals (United Kingdom); Crundwell, Malcolm [Royal Devon and Exeter NHSFT (United Kingdom); Adab, Fawzi A. [University Hospital of North Staffordshire NHS Trust (United Kingdom); Sheehan, Denise [Royal Devon and Exeter NHSFT (United Kingdom); Syndikus, Isabel [Clatterbridge Cancer Centre NHSFT (United Kingdom); Hendron, Carey [University of Birmingham (United Kingdom); Lewis, Rebecca; Waters, Rachel [Institute of Cancer Research (United Kingdom); James, Nicholas D. [University of Birmingham (United Kingdom)

    2013-10-01

    Purpose: To test whether reducing radiation dose to uninvolved bladder while maintaining dose to the tumor would reduce side effects without impairing local control in the treatment of muscle-invasive bladder cancer. Methods and Materials: In this phase III multicenter trial, 219 patients were randomized to standard whole-bladder radiation therapy (sRT) or reduced high-dose volume radiation therapy (RHDVRT) that aimed to deliver full radiation dose to the tumor and 80% of maximum dose to the uninvolved bladder. Participants were also randomly assigned to receive radiation therapy alone or radiation therapy plus chemotherapy in a partial 2 × 2 factorial design. The primary endpoints for the radiation therapy volume comparison were late toxicity and time to locoregional recurrence (with a noninferiority margin of 10% at 2 years). Results: Overall incidence of late toxicity was less than predicted, with a cumulative 2-year Radiation Therapy Oncology Group grade 3/4 toxicity rate of 13% (95% confidence interval 8%, 20%) and no statistically significant differences between groups. The difference in 2-year locoregional recurrence free rate (RHDVRT − sRT) was 6.4% (95% confidence interval −7.3%, 16.8%) under an intention to treat analysis and 2.6% (−12.8%, 14.6%) in the “per-protocol” population. Conclusions: In this study RHDVRT did not result in a statistically significant reduction in late side effects compared with sRT, and noninferiority of locoregional control could not be concluded formally. However, overall low rates of clinically significant toxicity combined with low rates of invasive bladder cancer relapse confirm that (chemo)radiation therapy is a valid option for the treatment of muscle-invasive bladder cancer.

  3. 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

    DEFF Research Database (Denmark)

    Andersson, Charlotte; Weeke, Peter; Brendorp, Bente;

    2009-01-01

    , but greater weight loss and diabetes were associated with smaller falls in blood uric acid levels; decreasing fasting and urinary glucose concentrations in diabetes were associated with increases in uric acid levels. CONCLUSION: A four week daily intake of sibutramine and life style changes was associated...... (mean +/- standard deviation) at screening were significantly higher among patients with CVD compared to patients without CVD (p ... 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....

  4. Unity in diversity: results of a randomized clinical culturally tailored pilot HIV prevention intervention trial in Baltimore, Maryland, for African American men who have sex with men.

    Science.gov (United States)

    Tobin, Karin; Kuramoto, Satoko J; German, Danielle; Fields, Errol; Spikes, Pilgrim S; Patterson, Jocelyn; Latkin, Carl

    2013-06-01

    Unity in Diversity was a randomized controlled trial of a culturally tailored HIV prevention intervention for African American men who have sex with men. The intervention condition was six group-based sessions and one individual session. The control condition was a single-session HIV prevention review. Participants were aged 18 years or older, identified as African American/Black race, reported having at least two sex partners in the prior 90 days (at least one of whom must be a male partner), unprotected anal sex with male partner in the prior 90 days, and willing to test for HIV. Retention exceeded 95% at 3-month follow-up. Results of multivariate logistic regression analysis adjusting for baseline risk, HIV status, and health insurance indicate intervention efficacy in decreasing the number of male sex partners and marginal effects on condom use with male partners and HIV-negative/unknown partners. Specifically, intervention condition was associated with increased odds of zero male sex partners (adjusted odds ratio [AOR] = 3.03, 95% confidence interval [CI] = 1.26-7.28), condom use with male partners (AOR = 2.64, 95% CI = 0.95-7.36), and HIV-negative/unknown status partners (AOR = 3.19, 95% CI = 0.98-10.38) at follow-up. These results contribute to the limited number of culturally appropriate models of HIV prevention intervention that are urgently needed for African American men who have sex with men to address their persistently high rates of HIV.

  5. The Effect of Cognitive Therapy on Structural Social Capital: Results From a Randomized Controlled Trial Among Sexual Violence Survivors in the Democratic Republic of the Congo

    Science.gov (United States)

    Bolton, Paul A.; Annan, Jeannie; Kaysen, Debra; Robinette, Katie; Cetinoglu, Talita; Wachter, Karin; Bass, Judith K.

    2014-01-01

    Objectives. We evaluated changes in social capital following group-based cognitive processing therapy (CPT) for female survivors of sexual violence. Methods. We compared CPT with individual support in a cluster-randomized trial in villages in South Kivu province, Democratic Republic of the Congo. Local psychosocial assistants delivered the interventions from April through July 2011. We evaluated differences between CPT and individual support conditions for structural social capital (i.e., time spent with nonkin social network, group membership and participation, and the size of financial and instrumental support networks) and emotional support seeking. We analyzed intervention effects with longitudinal random effects models. Results. We obtained small to medium effect size differences for 2 study outcomes. Women in the CPT villages increased group membership and participation at 6-month follow-up and emotional support seeking after the intervention compared with women in the individual support villages. Conclusions. Results support the efficacy of group CPT to increase dimensions of social capital among survivors of sexual violence in a low-income conflict-affected context. PMID:25033113

  6. Eye movement training results in changes in qEEG and NIH stroke scale in subjects suffering from acute middle cerebral artery ischemic stroke: a randomized control trial

    Directory of Open Access Journals (Sweden)

    Frederick Robert Carrick

    2016-01-01

    Full Text Available Context:Eye-movement training (EMT can induce altered brain activation and change the functionality of saccades with changes of the brain in general. Objective:To determine if EMT would result in changes in qEEG and NIH Stroke Scales (NIHSS in patients suffering from acute middle cerebral artery (MCA infarction. Our hypothesis is that there would be positive changes in qEEG and NIHSS after EMT in patients suffering from acute MCA ischemic stroke.Design:Double blind randomized controlled trial.Setting and Participants:34 subjects with acute MCA ischemic stroke at university affiliated hospital intensive care unit.Interventions:Subjects were randomized into a control group treated only with aspirin (125 mg/day and a treatment group treated with aspirin (125 mg/day and a subject specific EMT. Main Outcome measures: Delta-Alpha Ratio, Power Ratio Index and the Brain Symmetry Index calculated by quantitative electroencephalograms, and NIHSS. Results:There was strong statistical and substantive significant improvement in all outcome measures for the group of stroke patients undergoing EMT. Such improvement was not observed for the control group and there were no adverse effects.Conclusions:The addition of EMT to a MCA ischemic stroke treatment paradigm has demonstrated statistically significant changes in outcome measures and is a low cost, safe and effective complement to standard treatment.

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

    Directory of Open Access Journals (Sweden)

    Lars Rejnmark

    2010-01-01

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

  8. Human papillomavirus testing versus cytology in primary cervical cancer screening: End-of-study and extended follow-up results from the Canadian cervical cancer screening trial.

    Science.gov (United States)

    Isidean, Sandra D; Mayrand, Marie-Hélène; Ramanakumar, Agnihotram V; Gilbert, Laura; Reid, Stephanie L; Rodrigues, Isabel; Ferenczy, Alex; Ratnam, Sam; Coutlée, François; Franco, Eduardo L

    2016-12-01

    The Canadian Cervical Cancer Screening Trial was a randomized controlled trial comparing the performance of human papillomavirus (HPV) testing and Papanicolaou cytology to detect cervical intraepithelial neoplasia of grades 2 or worse (CIN2+) among women aged 30-69 years attending routine cervical cancer screening in Montreal and St. John's, Canada (n = 10,154). We examined screening and prognostic values of enrollment cytologic and HPV testing results. Extended follow-up data were available for St. John's participants (n = 5,754; 501,682.6 person-months). HPV testing detected more CIN2+ than cytology during protocol-defined (82.9 vs. 44.4%) and extended (54.2 vs. 19.3%) follow-up periods, respectively. Three-year risks ranged from 0.87% (95% CI: 0.37-2.05) for HPV-/Pap- women to 35.77% (95% CI: 25.88-48.04) for HPV+/Pap+ women. Genotype-specific risks ranged from 0.90% (95% CI: 0.40-2.01) to 43.84% (95% CI: 32.42-57.24) among HPV- and HPV16+ women, respectively, exceeding those associated with Pap+ or HPV+ results taken individually or jointly. Ten-year risks ranged from 1.15% (95% CI: 0.60-2.19) for HPV-/Pap- women to 26.05% (95% CI: 15.34-42.13) for HPV+/Pap+ women and genotype-specific risks ranged from 1.13% (95% CI: 0.59-2.14) to 32.78% (95% CI: 21.15-48.51) among women testing HPV- and HPV16+, respectively. Abnormal cytology stratified risks most meaningfully for HPV+ women. Primary HPV testing every 3 years provided a similar or greater level of reassurance against disease risks as currently recommended screening strategies. HPV-based cervical screening may allow for greater disease detection than cytology-based screening and permit safe extensions of screening intervals; genotype-specific testing could provide further improvement in the positive predictive value of such screening.

  9. 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

  10. Results of a Double-Blind, Randomized Trial of Ceftobiprole Treatment of Complicated Skin and Skin Structure Infections Caused by Gram-Positive Bacteria▿

    OpenAIRE

    2007-01-01

    Ceftobiprole is the first broad-spectrum cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA) to be assessed in late-stage clinical trials. As a pivotal step in the clinical development of ceftobiprole, a multicenter, global, randomized, double-blind trial was conducted to compare the efficacy of ceftobiprole to that of vancomycin in patients with complicated skin and skin structure infections (cSSSIs) caused by gram-positive bacteria. The primary objective w...

  11. 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

  12. 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

  13. Can a simulation-based training program impact the use of evidence based routine practices at birth? Results of a hospital-based cluster randomized trial in Mexico

    Science.gov (United States)

    Fritz, Jimena; Walker, Dilys M.; Cohen, Susanna; Angeles, Gustavo; Lamadrid-Figueroa, Hector

    2017-01-01

    Background In Mexico, although the majority of births are attended in hospitals, reports have emerged of obstetric violence, use of unsafe practices, and failure to employ evidence-based practices (EBP). Recent attention has refocused global efforts towards provision of quality care that is both patient-centered and evidence-based. Scaling up of local interventions should rely on strong evidence of effectiveness. Objective To perform a secondary analysis to evaluate the impact of a simulation and team-training program (PRONTO) on the performance of EBP in normal births. Methods A pair-matched cluster randomized controlled trial of the intervention was designed to measure the impact of the program (PRONTO intervention) on a sample of 24 hospitals (12 hospitals received the PRONTO training and 12 served as controls) in the states of Chiapas, Guerrero, and Mexico. We estimated the impact of receiving the intervention on the probability of birth practices performance in a sample of 641 observed births of which 318 occurred in the treated hospitals and 323 occurred in control hospitals. Data was collected at 4 time points (baseline, 4th, 8th and 12th months after the training). Women were blinded to treatment allocation but observers and providers were not. Estimates were obtained by fitting difference-in-differences logistic regression models considering confounding variables. The trial is registered at clinicaltrials.gov: # NCT01477554. Results Significant changes were found following the intervention. At 4 months post-intervention an increase of 20 percentage points (p.p.) for complete Active Management of Third Stage of Labor (AMTSL) (p = 0.044), and 16 p.p. increase for Skin-to-Skin Contact (p = 0.067); at 12 months a 25 p.p. increase of the 1st step of AMTSL (p = 0.026) and a 42 p.p. increase of Delayed Cord Clamping (p = 0.004); at 4 months a 30 (p = 0.001) and at 8 months a 22 (p = 0.010) p.p. decrease for Uterine Sweeping. Conclusions The intervention has an

  14. 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

  15. 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

    2013-01-01

    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

  16. Neurobiological Aspects of Mindfulness in Pain Autoregulation: Unexpected Results from a Randomized-Controlled Trial and Possible Implications for Meditation Research

    Science.gov (United States)

    Esch, Tobias; Winkler, Jeremy; Auwärter, Volker; Gnann, Heike; Huber, Roman; Schmidt, Stefan

    2017-01-01

    Background: Research has demonstrated that short meditation training may yield higher pain tolerance in acute experimental pain. Our study aimed at examining underlying mechanisms of this alleged effect. In addition, placebo research has shown that higher pain tolerance is mediated via endogenous neuromodulators: experimental inhibition of opioid receptors by naloxone antagonized this effect. We performed a trial to discern possible placebo from meditation-specific effects on pain tolerance and attention. Objectives: It was proposed that (i) meditation training will increase pain tolerance; (ii) naloxone will inhibit this effect; (iii) increased pain tolerance will correlate with improved attention performance and mindfulness. Methods: Randomized-controlled, partly blinded trial with 31 healthy meditation-naïve adults. Pain tolerance was assessed by the tourniquet test, attention performance was measured by Attention Network Test (ANT), self-perceived mindfulness by Freiburg Mindfulness Inventory. 16 participants received a 5-day meditation training, focusing on body/breath awareness; the control group (N = 15) received no intervention. Measures were taken before the intervention and on 3 consecutive days after the training, with all participants receiving either no infusion, naloxone infusion, or saline infusion (blinded). Blood samples were taken in order to determine serum morphine and morphine glucuronide levels by applying liquid chromatography-tandem mass spectrometry analysis. Results: The meditation group produced fewer errors in ANT. Paradoxically, increases in pain tolerance occurred in both groups (accentuated in control), and correlated with reported mindfulness. Naloxone showed a trend to decrease pain tolerance in both groups. Plasma analyses revealed sporadic morphine and/or morphine metabolite findings with no discernable pattern. Discussion: Main objectives could not be verified. Since underlying study goals had not been made explicit to

  17. 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

  18. 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

  19. Neurobiological Aspects of Mindfulness in Pain Autoregulation: Unexpected Results from a Randomized-Controlled Trial and Possible Implications for Meditation Research.

    Science.gov (United States)

    Esch, Tobias; Winkler, Jeremy; Auwärter, Volker; Gnann, Heike; Huber, Roman; Schmidt, Stefan

    2016-01-01

    Background: Research has demonstrated that short meditation training may yield higher pain tolerance in acute experimental pain. Our study aimed at examining underlying mechanisms of this alleged effect. In addition, placebo research has shown that higher pain tolerance is mediated via endogenous neuromodulators: experimental inhibition of opioid receptors by naloxone antagonized this effect. We performed a trial to discern possible placebo from meditation-specific effects on pain tolerance and attention. Objectives: It was proposed that (i) meditation training will increase pain tolerance; (ii) naloxone will inhibit this effect; (iii) increased pain tolerance will correlate with improved attention performance and mindfulness. Methods: Randomized-controlled, partly blinded trial with 31 healthy meditation-naïve adults. Pain tolerance was assessed by the tourniquet test, attention performance was measured by Attention Network Test (ANT), self-perceived mindfulness by Freiburg Mindfulness Inventory. 16 participants received a 5-day meditation training, focusing on body/breath awareness; the control group (N = 15) received no intervention. Measures were taken before the intervention and on 3 consecutive days after the training, with all participants receiving either no infusion, naloxone infusion, or saline infusion (blinded). Blood samples were taken in order to determine serum morphine and morphine glucuronide levels by applying liquid chromatography-tandem mass spectrometry analysis. Results: The meditation group produced fewer errors in ANT. Paradoxically, increases in pain tolerance occurred in both groups (accentuated in control), and correlated with reported mindfulness. Naloxone showed a trend to decrease pain tolerance in both groups. Plasma analyses revealed sporadic morphine and/or morphine metabolite findings with no discernable pattern. Discussion: Main objectives could not be verified. Since underlying study goals had not been made explicit to

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

    Energy Technology Data Exchange (ETDEWEB)

    Izquierdo, M. [Instituto de Ciencias de la Construccion Eduardo Torroja (CSIC), c/Serrano Galvache 4, 28033 Madrid (Spain); Unidad Asociada de Ingenieria Termica y Fluidos CSIC-UC3M (Spain)], E-mail: mizquierdo@ietcc.csic.es; Lizarte, R. [Universidad Carlos III de Madrid, Escuela Politecnica Superior, Avenida de la Universidad 30, 28911 Leganes, Madrid (Spain); Unidad Asociada de Ingenieria Termica y Fluidos CSIC-UC3M (Spain); Marcos, J.D. [Escuela Tecnica Superior Ingenieria Industrial, UNED, c/Juan del Rosal 12, 28040 Madrid (Spain); Unidad Asociada de Ingenieria Termica y Fluidos CSIC-UC3M (Spain); Gutierrez, G. [Universidad Carlos III de Madrid, Escuela Politecnica Superior, Avenida de la Universidad 30, 28911 Leganes, Madrid (Spain); Unidad Asociada de Ingenieria Termica y Fluidos CSIC-UC3M (Spain)

    2008-06-15

    Trials were conducted to determine the performance of a commercial (Rotartica 045v) 4.5-kW air-cooled, single effect LiBr/H{sub 2}O absorption chiller for residential use. The experiments were run at La Poveda, Arganda del Rey, Madrid, in August 2005. Three typical August days, with different outdoor temperatures, were chosen for the study. The hot water inlet temperature in the generator varied throughout the day from 80 to 107 {sup o}C. Thermal demand was calculated, along with period energy balance and COP. Variations in machine component temperatures were recorded and chilling power and the daily COP calculated for each of the three days. The results for the period as a whole showed that cooling power tended to decline with rising outdoor dry bulb temperatures. At temperatures from 35 to 41.3 {sup o}C the chilled water outlet temperature in the evaporator climbed to over 15 {sup o}C. The average COP for the period, when auxiliary equipment was included into the calculations, was 0.37.

  1. Home-based cardiac rehabilitation is as effective as centre-based cardiac rehabilitation among elderly with coronary heart disease: results from a randomised clinical trial

    DEFF Research Database (Denmark)

    Oerkild, Bodil; Frederiksen, Marianne; Hansen, Jorgen Fischer;

    2011-01-01

    in the secondary outcomes of systolic blood pressure (-0.6 mmHg, 95% CI -11.3, 10.0), LDL cholesterol (0.3 mmol/l, 95% CI -0.04, 0.7), HDL cholesterol (0.2 mmol/l, 95% CI -0.01, 0.3), body composition, proportion of smokers and health-related quality of life. A group of patients who did not have an effect......BACKGROUND: participation in centre-based cardiac rehabilitation (CR) is known to reduce morbidity and mortality but participation rates among the elderly are low. Establishing alternative programmes is important, and home-based CR is the predominant alternative. However, no studies have...... investigated the effect of home-based CR among a group of elderly patients with coronary heart disease with a long-term follow-up. METHODS: randomised clinical trial comparing home-based CR with comprehensive centre-based CR among patients = 65 years with coronary heart disease. RESULTS: seventy-five patients...

  2. 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

  3. 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.

  4. Optimized rapeseed oil enriched with healthy micronutrients: a relevant nutritional approach to prevent cardiovascular diseases. Results of the Optim'Oils randomized intervention trial.

    Science.gov (United States)

    Gladine, Cécile; Combe, Nicole; Vaysse, Carole; Pereira, Bruno; Huertas, Alain; Salvati, Serafina; Rossignol-Castera, Anne; Cano, Noël; Chardigny, Jean-Michel

    2013-03-01

    Rapeseeds are naturally rich in cardioprotective micronutrients but refining leads to substantial losses or the production of undesirable compounds. The Optim'Oils European project proposed innovative refining conditions to produce an optimized rapeseed oil enriched in micronutrients and low in trans linolenic acid. We aimed to investigate cardioprotective properties of this Optimized oil. In a randomized, double-blind, controlled, cross-over study, 59 healthy normolipidaemic men consumed either Optimized or Standard rapeseed oils (20 g/d) and margarines (22 g/d) for 3 weeks. The Optimized oil reduced the trans FA concentration (p=0.009) and increased the contents of alpha-tocopherol (p=0.022) and coenzyme Q10 (poil. Over the 3-week trial, Total-/HDL-cholesterol and LDL-/HDL-cholesterol were increased by 4% (poil consumption whereas none of them rose with the Optimized rapeseed oil which increased the HDL-cholesterol and ApoA1 plasma content (+2%, NS and +3%, prapeseed oil. Finally, the Optimized oil reduced the plasma content of LDLox (-6%, NS), this effect being significantly different from the Standard oil (p=0.050). In conclusion, reasonable intake of an Optimized rapeseed oil resulting from innovative refining processes and enriched in cardioprotective micronutrients represent a relevant nutritional approach to prevent the risk of cardiovascular diseases by improving the cholesterol profile and reducing LDL oxidation.

  5. 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.

  6. Following the results of the EMPA-REG OUTCOME trial with empagliflozin, is it possible to speak of a class effect?

    Science.gov (United States)

    Ampudia-Blasco, Francisco Javier; Romera, Irene; Ariño, Bernat; Gomis, Ramón

    2017-01-01

    Background The recently published cardiovascular outcomes data for the first sodium–glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin, have shown cardiovascular safety and additional benefits in patients with type 2 diabetes and established cardiovascular disease. Empagliflozin showed lower rates of death from cardiovascular causes or from any causes and lower hospitalization rates from heart failure compared with placebo, both in addition to standard care. This commentary discusses the existence of a possible class effect considering the available evidence described for other SGLT2 inhibitors. Main text Empagliflozin, dapagliflozin and canagliflozin share the same mechanism of action, and it is a plausible hypothesis that some of the benefits of empagliflozin treatment could also be expected from other SGLT2 inhibitors. However, the rapid and persistent occurrence of cardiovascular benefits observed with empagliflozin and the different results shown by the three inhibitors in meta-analyses of some of their respective Phase II and III trials might suggest another possible mechanism of action, perhaps related to the different selectivity to inhibit SGLT-2 and other SGLT family members that these compounds present. Conclusion There is still lack of evidence to answer whether the cardiovascular benefits observed with empagliflozin in the EMPA-REG OUTCOME study could be seen as a “class effect”, which is also attributable to dapagliflozin and canagliflozin. PMID:28144158

  7. 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.

  8. 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.

  9. Healthcare Costs Reduced After Incorporating the Results of the American College of Surgeons Oncology Group Z0011 Trial into Clinical Practice.

    Science.gov (United States)

    Fillion, Michelle M; Glass, Katherine E; Hayek, Joe; Wehr, Allison; Phillips, Gary; Terando, Alicia; Agnese, Doreen M

    2016-11-30

    The purpose of our study was to quantitate the changes in axillary lymph node dissection (ALND), frozen section (FS), and the impact on costs after the publication of the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial. We compared axillary nodal management and cost data in breast cancer patients who met Z0011 criteria and were treated with lumpectomy and sentinel lymph nodes (SLN) biopsy from 2007 to July 2013. Of 800 patients, 67 (13.5%) and 34 (12.5%) patients in the pre- and post-Z0011 era had 1-2 positive SLN. ALND decreased from 78% to 21% (p < 0.001) after publication of Z0011. The mean overall cost of SLN biopsy was $41,059 per patient, while SLN biopsy with completion ALND was $50,999 (p < 0.001). Intraoperative FS use decreased from 95% to 66% (p = 0.015). Omitting the FS decreased mean costs from $4,319 to $2,036. The application of Z0011 resulted in an overall mean cost savings of $571,653 from 2011 to July 2013. ACOSOG Z0011 significantly impacted axillary management resulting in a 20% reduction in the mean overall cost per patient by omitting ALND. In these patients, intraoperative FS analysis had poor sensitivity (56%) and doubled the cost of pathologic examination. Fewer ALND and intraoperative FS were performed after the publication of ACOSOG Z0011. Eliminating FS and ALND in patients who met Z0011 criteria, results in significant cost savings.

  10. Combination verteporfin photodynamic therapy ranibizumab-dexamethasone in choroidal neovascularization due to age-related macular degeneration: results of a phase II randomized trial

    Science.gov (United States)

    Gallemore, Ron P; Wallsh, Josh; Hudson, Henry L; Ho, Allen C; Chace, Richard; Pearlman, Joel

    2017-01-01

    Purpose To assess whether combination therapy (CT) reduces retreatments when compared to ranibizumab monotherapy (RM), while safely maintaining similar vision outcomes. Methods In this 24-month trial, patients with age-related macular degeneration (AMD) were randomized to 1) quarter-fluence or 2) half-fluence triple therapy (verteporfin photodynamic therapy [vPDT] + ranibizumab + dexamethasone), 3) half-fluence double therapy (vPDT + ranibizumab), or 4) RM. The primary outcomes were number of retreatment visits and change from baseline in visual acuity (VA) at 12 months. Results One hundred sixty-two subjects enrolled. There were 4.0 (P=0.02), 3.2 (P<0.001), 4.1 (P=0.03), and 5.7 retreatment visits through month 12, and 5.9 (P=0.03), 4.3 (P<0.001), 5.9 (P=0.02) and 8.7 through month 24, in groups 1, 2, 3, and 4, respectively (P-value comparing with RM). Month 12 VA score change from baseline (95% confidence interval) was +3.6 (−0.9 to +8.1), +6.8 (+2.4 to +11.1), +5.0 (+0.6 to +9.3), and +6.5 (+1.7 to +11.4), respectively. Conclusion CT resulted in significantly fewer retreatment visits than a RM regimen at months 12 and 24. VA results appeared similar although wide confidence intervals preclude conclusions regarding vision outcomes. PMID:28182161

  11. 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.

  12. 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.

  13. 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.

  14. Cost evaluation of gadoxetic acid-enhanced magnetic resonance imaging in the diagnosis of colorectal-cancer metastasis in the liver: Results from the VALUE Trial

    Energy Technology Data Exchange (ETDEWEB)

    Zech, Christoph J. [University Hospital Basel, Clinic of Radiology und Nuclear Medicine, Basel (Switzerland); Justo, Nahila; Lang, Andrea [OptumInsight, Life Sciences, Stockholm (Sweden); Ba-Ssalamah, Ahmed [Medical University of Vienna, Department of Radiology, General Hospital of Vienna (AKH), Vienna (Austria); Kim, Myeong-Jin [Yonsei University, Severance Hospital, Seoul (Korea, Republic of); Rinde, Harald [BioBridge Strategies, Binningen (Switzerland); Jonas, Eduard [Karolinska University Hospital, Department of Upper Abdominal Surgery, Stockholm (Sweden)

    2016-11-15

    To assess the costs of diagnostic workup and surgery of three strategies for patients with colorectal cancer liver-metastases (CRCLM): gadoxetic-acid-enhanced MRI (Gd-EOB-DTPA-MRI), MRI with extracellular contrast-media (ECCM-MRI) or contrast-enhanced MDCT (CE-MDCT). The within-trial cost evaluation was modelled as a decision-tree to calculate the cost of diagnosis and surgery. The model used clinical outcomes and resource utilization data from a prospective randomized multicentre study. Analyses were performed for the 354-patient safety population from eight participating countries. The diagnostic workup cost using Gd-EOB-DTPA-MRI upfront resulted in savings compared to ECCM-MRI in all countries except Thailand (difference <2 %). Compared to CE-MDCT, initial imaging with Gd-EOB-DTPA-MRI was less costly in all countries except Korea and Spain (differences 4 and 8 %, respectively). Significantly more patients in the Gd-EOB-DTPA-MRI group were eligible for surgery (39.3 % (48/122) vs. 31.0 % (36/116) and 26.7 % (31/116) for ECCM-MRI and CE-MDCT, respectively), allowing more patients to undergo potentially curative surgery, but resulting in higher treatment costs for the strategy starting with Gd-EOB-DTPA-MRI. The benefits of Gd-EOB-DTPA-MRI due to less additional imaging and similar diagnostic workup costs in the three groups suggest that Gd-EOB-DTPA-MRI should be the preferred initial imaging procedure to evaluate hepatic resectability in patients with CRCLM. (orig.)

  15. Feasibility of Identifying a Female Sex Worker Cohort at High Risk of HIV Infection in the Caribbean for HIV Vaccine Efficacy Trials: Longitudinal Results of HVTN 907

    Science.gov (United States)

    Deschamps, Marie Marcelle; Metch, Barbara; Morgan, Cecilia A; Zorrilla, Carmen D; Donastorg, Yeycy; Swann, Edith; Taina, Dadaille; Patrice, Joseph; JW, Pape

    2015-01-01

    Background Identifying cohorts of Caribbean women with HIV infection rates sufficient for inclusion in HIV vaccine efficacy trials has been challenging. HVTN 907 determined the feasibility of identifying and retaining a cohort of women at high risk for HIV acquisition by focusing recruitment on female sex workers (FSW). Methods HIV uninfected FSWs, residing in Haiti, Dominican Republic (DR) and Puerto Rico (PR), who reported unprotected sex and met previously described more stringent site-specific eligibility criteria14, were eligible. Behavioral risk assessment, HIV counseling and testing and pregnancy testing were done at baseline, 6, 12, and 18 months. Results Among 799 FSWs (264 from DR, 334 from Haiti, 201 from PR), the median age was 26 years, with 54% having less than a high school education and 45% having a monthly household income of less than $US100. Median number of male partners six months prior to screening was 200. Retention at 18 months was 93%. Twelve women became HIV infected, nine from Haiti. The annualized HIV incidence was 1.07 % (95% CI 0.55%, 1.87%). Pregnancy incidence was 22.5% (95% CI 21.9, 29.5%). Statistically significant declines in risk behaviors occurred between screening and the 18 month visit assessment. Discussion The HVTN 907 study identified a high risk cohort of women with excellent retention for all 3 sites, despite major challenges especially in Haiti. These results show that a bridging study of a vaccine shown to be efficacious in other clade settings would be possible among FSW in the region, particularly in Haiti. PMID:26761272

  16. Immune modulation in type 1 diabetes mellitus using DiaPep277: a short review and update of recent clinical trial results.

    Science.gov (United States)

    Eldor, Roy; Kassem, Sameer; Raz, Itamar

    2009-05-01

    In type 1 diabetes mellitus, autoimmune T-cells mount an attack on insulin producing beta-cells eventually causing hyperglycemia. It is hypothesized, that to prevent and treat this disease, one must interfere with the autoimmune process. To avoid hazardous side effects, this intervention should not cause a global immune suppression but immune modulation. DiaPep277 (peptide 277) is a 24 amino acid peptide derived from positions 437-460 in HSP60. It has recently been shown to have an immune modulatory effect on diabetogenic T cells in animal models of diabetes. It has also been recently implicated as a possible auto-antigen in type 1 diabetes. Promising results in animal models led to phase 1 to 3 human clinical trials in patients with type 1 diabetes, the results of which are the focus of this review. A combined analysis of all the adult phase II studies revealed that DiaPep277 significantly inhibits the decline in stimulated C-peptide secretion (thus preserving endogenous insulin secretion). This effect was more pronounced in patients with a high beta-cell reserve at the start of the treatment. Furthermore, opposite trends in glycemic control of DiaPep277 treated patients where noted as opposed to placebo treated patients. The phase III study has began more than 2 years ago in 40 medical centers worldwide, and thus far recruited over 350 patients around the world. If DiaPep277 will prove to be efficacious, it will cause a paradigm shift in the treatment of type 1 diabetes, from treating the subsequent insulin deficiency to addressing the initial autoimmune process that is at the heart of the disease.

  17. 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.

  18. Chlamydia pneumoniae IgG and IgA antibody titers and prognosis in patients with coronary heart disease: results from the CLARICOR trial

    DEFF Research Database (Denmark)

    Hilden, Jørgen; Lind, Inga; Kolmos, Hans Jørn

    2010-01-01

    The association observed between coronary heart disease (CHD) and Chlamydia (Chlamydophila) pneumoniae antibodies prompted, during the 1990s, several primary and secondary prevention trials with various antibiotics. In our CLARICOR trial, a randomized placebo-controlled trial in 4372 patients...... with stable CHD, a brief clarithromycin regimen was followed, unexpectedly, by increased long-term mortality. We now compare C. pneumoniae antibody levels at entry with population levels, with the patients' individual histories, and with their subsequent outcomes. IgG antibody levels were somewhat raised...... clarithromycin effect was unrelated to antibody levels and remains unexplained. Smoking-related lung disease probably underlies the link between heart disease and increased IgG titers....

  19. How do the results of the RADIANT trials impact on the management of NET patients? A systematic review of published studies.

    Science.gov (United States)

    Pusceddu, Sara; De Braud, Filippo; Lo Russo, Giuseppe; Concas, Laura; Femia, Daniela; Vernieri, Claudio; Indini, Alice; Formisano, Barbara; Buzzoni, Roberto

    2016-07-12

    In the last five years, everolimus has demonstrated efficacy in the treatment of neuroendocrine tumors (NETs) of different origins; its efficacy and safety were explored in the RADIANT trials, the last of which (RADIANT-4) has been recently published (December 2015). Overall, evidence collected from the RADIANT studies holds promise to change clinical practice for the treatment of NETs.In this paper, we comment on the role of everolimus within the therapeutic algorithm for NETs treatment, based on the systematic analysis of the RADIANT trials and our experience.

  20. 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.

  1. 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

  2. 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

  3. 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

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    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.

  4. 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.

  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. Correlation in Rectal Cancer Between Clinical Tumor Response After Neoadjuvant Radiotherapy and Sphincter or Organ Preservation: 10-Year Results of the Lyon R 96-02 Randomized Trial

    Energy Technology Data Exchange (ETDEWEB)

    Ortholan, Cecile [Department of Radiation Oncology, Antoine Lacassagne Cancer Center, Nice, UNSA (Universite de Nice Sophia-Antipolis) (France); Department of Oncology-Radiotherapy, Hopital Princesse Grace, Monaco (France); Romestaing, Pascale [Hopital Prive Jean Mermoz, Lyon (France); Chapet, Olivier [Department of Radiation Oncology, Lyon Sud University Hospital, Hospices Civils de Lyon, Lyon (France); Gerard, Jean Pierre, E-mail: jean-pierre.gerard@nice.unicancer.fr [Department of Radiation Oncology, Antoine Lacassagne Cancer Center, Nice, UNSA (Universite de Nice Sophia-Antipolis) (France)

    2012-06-01

    Purpose: To investigate, in rectal cancer, the benefit of a neoadjuvant radiation dose escalation with endocavitary contact radiotherapy (CXRT) in addition to external beam radiotherapy (EBRT). This article provides an update of the Lyon R96-02 Phase III trial. Methods and Materials: A total of 88 patients with T2 to T3 carcinoma of the lower rectum were randomly assigned to neoadjuvant EBRT 39 Gy in 13 fractions (43 patients) vs. the same EBRT with CXRT boost, 85 Gy in three fractions (45 patients). Median follow-up was 132 months. Results: The 10-year cumulated rate of permanent colostomy (CRPC) was 63% in the EBRT group vs. 29% in the EBRT+CXRT group (p < 0.001). The 10-year rate of local recurrence was 15% vs. 10% (p = 0.69); 10-year disease-free survival was 54% vs. 53% (p = 0.99); and 10-year overall survival was 56% vs. 55% (p = 0.85). Data of clinical response (CR) were available for 78 patients (36 in the EBRT group and 42 in the EBRT+CXRT group): 12 patients were in complete CR (1 patient vs. 11 patients), 53 patients had a CR {>=}50% (24 patients vs. 29 patients), and 13 patients had a CR <50% (11 patients vs. 2 patients) (p < 0.001). Of the 65 patients with CR {>=}50%, 9 had an organ preservation procedure (meaning no rectal resection) taking advantage of major CR. The 10-year CRPC was 17% for patients with complete CR, 42% for patients with CR {>=}50%, and 77% for patients with CR <50% (p = 0.014). Conclusion: In cancer of the lower rectum, CXRT increases the complete CR, turning in a significantly higher rate of long-term permanent sphincter and organ preservation.

  7. 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

  8. Intravenous acetaminophen is superior to ketamine for postoperative pain after abdominal hysterectomy: results of a prospective, randomized, double-blind, multicenter clinical trial

    Directory of Open Access Journals (Sweden)

    Faiz HR

    2014-01-01

    Full Text Available Hamid Reza Faiz,1 Poupak Rahimzadeh,1 Ognjen Visnjevac,2 Behzad Behzadi,1 Mohammad Reza Ghodraty,1 Nader D Nader2 1Iran University of Medical Sciences, Tehran, Iran; 2VA Western NY Healthcare System, University at Buffalo, Buffalo, NY, USA Background: In recent years, intravenously (IV administered acetaminophen has become one of the most common perioperative analgesics. Despite its now-routine use, IV acetaminophen's analgesic comparative efficacy has never been compared with that of ketamine, a decades-old analgesic familiar to obstetricians, gynecologists, and anesthesiologists alike. This double-blind clinical trial aimed to evaluate the analgesic effects of ketamine and IV acetaminophen on postoperative pain after abdominal hysterectomy. Methods: Eighty women aged 25–70 years old and meeting inclusion and exclusion criteria were randomly allocated into two groups of 40 to receive either IV acetaminophen or ketamine intraoperatively. Postoperatively, each patient had patient-controlled analgesia. Pain and sedation (Ramsay Sedation Scale were documented based on the visual analog scale in the recovery room and at 4 hours, 6 hours, 12 hours, and 24 hours after the surgery. Hemodynamic changes, adverse medication effects, and the need for breakthrough meperidine were also recorded for both groups. Data were analyzed by repeated-measures analysis of variance. Results: Visual analog scale scores were significantly lower in the IV acetaminophen group at each time point (P<0.05, and this group required significantly fewer doses of breakthrough analgesics compared with the ketamine group (P=0.039. The two groups had no significant differences in terms of adverse effects. Conclusion: Compared with ketamine, IV acetaminophen significantly improved postoperative pain after abdominal hysterectomy. Keywords: intravenous acetaminophen, abdominal hysterectomy, ketamine, analgesia, postoperative pain

  9. 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

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    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.

  10. 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 thera