Artigos de revistas: "Experimental trials"

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Bolton, Sanford. "Experimental Design in Clinical Trials". Clinical Research and Regulatory Affairs 17, n.º 4 (janeiro de 2000): 285–344. http://dx.doi.org/10.3109/10601330009010839.

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Hamilton, E. P., G. H. Lyman, S. Kim e J. Peppercorn. "Availability of experimental therapy outside of randomized clinical trials in oncology". Journal of Clinical Oncology 27, n.º 15_suppl (20 de maio de 2009): 6539. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.6539.

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6539 Background: Investigational cancer therapies may be available outside of trials, or “off protocol” (OPRx), with implications for patient safety, trial accrual, and access to care. Previous studies suggest OPRx is prevalent in oncology, but there is little consensus on when it should or should not be considered. We evaluated the scope and impact of OPRx through assessment of availability of the experimental arms of recent randomized trials (RCT), and evaluation of study outcomes and accrual. Methods: We conducted a Medline search to identify all English language phase III RCT of medical interventions in oncology over a 2-year period ending April 17, 2008. We determined availability of experimental interventions based on FDA approval for any indication. We limited assessment of accrual (time to trial completion, patients/month) to studies with US sites. Significance of results was assessed by Fisher's exact test and unpaired t-test. Results: We identified 172 eligible RCT. The majority of RCT (108, 63%) evaluated drugs that were available OPRx at trial initiation, while an additional 19 (11%) trial drugs became available during the trial. 64 (55%) were available due to FDA approval for the same cancer in a different setting, 40 (35%) for a different cancer, and 12 (10%) for a non-cancer indication. 25% of trials were conducted at only US sites, 15% included US and international sites, and 60% were international only. Trials in which OPRx was available had slower time to completion compared to trials in which OPRx was unavailable (48 vs. 26 months, p = 0.04) and a trend towards slower accrual (14.0 vs. 40.7 patients/month, p = 0.06). For the majority of RCT (66%), there was at least one grade 3/4 toxicity that was greater in the experimental arm, for 47% the experimental interventions proved superior for 1 major outcome, and 27% demonstrated improvement in overall survival. These outcomes did not vary based on availability OPRx. Conclusions: The majority of recent oncology trials involve experimental regimens that are available outside of a trial. The safety and efficacy of novel interventions must be determined by trials but availability of OPRX may impact accrual. Guidelines are needed for OPRx in oncology. No significant financial relationships to disclose.

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Cicchetti, Americo, Domenico Addesso, Filippo Elvino Leone, Antonino Amato, Luca Angerame, Angelo D'Aversa, Mario Fraticelli et al. "Valorization of clinical trials from the Italian National Health Service perspective: definition and first application of a model to estimate avoided costs". Global & Regional Health Technology Assessment 7, n.º 1 (16 de junho de 2020): 26–32. http://dx.doi.org/10.33393/grhta.2020.709.

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Introduction: From the perspective of healthcare organizations and public health care systems, the value of a clinical trial can be assessed from a clinical and economical perspective. However, to date, there is no standardized model for systematically capturing the economic value of clinical trials at organizational and system levels. The aim of this study was to develop and test a methodology for estimating the avoided costs deriving from the management of patients as part of a clinical trial. Methods: Our methodology is based on the assumption that the economic value of a clinical trial derives from 1) the funding received by the experimental site from a trial’s sponsor, and from 2) the cost avoided by the experimental site with the treatment of patients within a study and not according to standard care by the experimental site. Results: By applying the methodology to onco-hematological clinical trials conducted in two academic hospitals from 2011 to 2016, we demonstrate that savings between 2 million and 4 million euros were achieved over a five-year period. Thus, for every 1,000 euros invested by the pharmaceutical company into the clinical studies conducted at these hospitals, the hospitals saved on average 2,200 euros due to costs not incurred as a result of the trials. Conclusions: The study has proposed and tested a methodology for estimating the economic value of clinical trials by taking into account avoided costs deriving from the treatment of patients enrolled in sponsored trials. The study has proposed a management tool for healthcare institutions to govern clinical trials.

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Menefee, Michael E., Yutao Gong, Pallavi Shruti Mishra-Kalyani, Rajeshwari Sridhara, Bindu Kanapuru, Gideon Michael Blumenthal e Richard Pazdur. "Project Switch: Docetaxel as a potential synthetic control in metastatic non-small cell lung cancer (mNSCLC) trials." Journal of Clinical Oncology 37, n.º 15_suppl (20 de maio de 2019): 9105. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.9105.

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9105 Background: Docetaxel is a common comparator arm to test novel therapies in post-platinum mNSCLC trials. The advent of Real World Evidence (RWE) has renewed interest in the use of synthetic control arms (control arms from previously conducted randomized trials) to improve accrual to trials and increase patient access of promising experimental agents. We reviewed legacy second-line (2L) mNSCLC trials to assess the impact of switching docetaxel control arms from one trial to another and compare to an experimental regimen. Methods: We identified 5 contemporary 2L trials that enrolled 2013 patients receiving an experimental therapy vs. docetaxel: 5 immunoncology head-to-head trials (one with 2 arms) and one anti-VEGF add-on trial. Kaplan-Meier curves of overall survival (OS) and progression-free survival (PFS) were produced for docetaxel controls. We calculated OS and PFS hazard ratios and 95% confidence intervals for each synthetic trial. A pooled doc arm was also compared with each experimental agent. Results: See Table. Conclusions: Both individual and pooled docetaxel switching of control arms approximated the original OS HR and 95% CI. Methods such as bootstrapped sampling and propensity score matching will be performed in an effort to more closely approximate the original trial characteristics. [Table: see text]

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Hamilton, Erika P., Gary H. Lyman e Jeffrey Peppercorn. "Availability of Experimental Therapy Outside Oncology Randomized Clinical Trials in the United States". Journal of Clinical Oncology 28, n.º 34 (1 de dezembro de 2010): 5067–73. http://dx.doi.org/10.1200/jco.2010.28.6567.

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Purpose Investigational cancer therapies may be available outside trials as “off-protocol therapy” (OPRx), with implications for patient safety, trial accrual, and access to care. We conducted a literature-based analysis of recent randomized trials to evaluate the potential scope and impact of OPRx in the United States. Methods A MEDLINE search identified all English-language phase III medical oncology randomized clinical trials (RCTs) published over a 2-year period ending April 17, 2008. Determination of OPRx availability was based on US Food and Drug Administration approval for any indication. We limited assessment of accrual to studies with US sites. Data from articles were extracted independently by two investigators. Results Among 172 eligible RCTs, the majority (108; 63%) evaluated drugs that were available OPRx in the United States at trial initiation, while an additional 19 (11%) evaluated interventions that became available during the trial. Among trials with US sites, time to accrual was slower (41 vs 22 months; P = .002) and less efficient (8.8 v 22.7 patients per month; P = .001) when OPRx was available. Sixty-six percent of RCTs reported at least one increased grade 3 to 4 toxicity in the experimental arm, 47% reported superior efficacy for at least one major clinical outcome in the experimental arm, and 27% reported improvement in overall survival. These outcomes did not vary on the basis of OPRx availability. Conclusion The majority of recent oncology RCTs involve experimental interventions that are available outside trials in the United States with potential impact on trial accrual. The safety and efficacy of novel interventions must be determined by clinical trials.

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Fujinaka, Hidehiko, Masanori Hara, Makoto Uchiyama, Eishin Yaoita, Katsutoshi Kawasaki, Tadashi Yamamoto e Itaru Kihara. "Therapeutic Trials of Experimental Crescentic Glomerulonephritis." Nihon Shoni Jinzobyo Gakkai Zasshi 10, n.º 1 (1997): 87–91. http://dx.doi.org/10.3165/jjpn.10.87.

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Salama, Ragga H., Abd El Rahman G. Ramadan, Tasneem A. Alsanory, Mohammed O. Herdan, Omnia M. Fathallah e Aya A. Alsanory. "Experimental and Therapeutic Trials of Amygdalin". International Journal of Biochemistry and Pharmacology 1, n.º 1 (28 de outubro de 2019): 21–26. http://dx.doi.org/10.18689/ijbp-1000105.

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Finkel, R. "Experimental trials in spinal muscular atrophy". Neuromuscular Disorders 27 (março de 2017): S2. http://dx.doi.org/10.1016/s0960-8966(17)30224-9.

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Gibbs, Lauren. "Rethinking Eligibility for Experimental Clinical Trials". JAMA Neurology 75, n.º 1 (1 de janeiro de 2018): 22. http://dx.doi.org/10.1001/jamaneurol.2017.3492.

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Fast, Patricia E., e Mary Clare Walker. "Human trials of experimental AIDS vaccines". AIDS 7 (janeiro de 1992): S147—S160. http://dx.doi.org/10.1097/00002030-199201001-00020.

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Fast, Patricia E., e Mary Clare Walker. "Human trials of experimental AIDS vaccines". AIDS 7 (janeiro de 1993): S147—S160. http://dx.doi.org/10.1097/00002030-199301001-00020.

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Snart, Ronald S. "Human trials of experimental AIDS vaccines". AIDS 2 (1988): S107–112. http://dx.doi.org/10.1097/00002030-198800001-00016.

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Storck, Lindolfo, Sidinei José Lopes, Alberto Cargnelutti Filho, Alessandro Dal'Col Lúcio e Marcos Toebe. "Experimental precision in corn trials using the Papadakis method". Ciência e Agrotecnologia 34, n.º 6 (dezembro de 2010): 1458–64. http://dx.doi.org/10.1590/s1413-70542010000600015.

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The objective of this work was to verify whether the use of the Papadakis method in competing corn hybrid trials would lead to modifications in the validity of assumptions for the mathematical model of variance analysis and for experimental precision indicators. To achieve this, corn-grain-yield data from 25 competing corn hybrid trials, performed in a design of complete randomized blocks, were examined. Each trial entailed verification of assumptions, variance analysis, hypothesis tests, statistics to identify experimental precision, and analysis using the Papadakis method. This method improves experimental precision indicators. The assumptions were valid for both analysis types (without Papadakis and with Papadakis). Mean figures for the Fasoulas differentiation index increased from 8.5 to 20.7 and selective precision rose from 0.82 to 0.92. Trials with three repetitions analyzed using the Papadakis method enabled the identification of superior corn hybrids in relation to grain yield, with 86.5% precision. To maintain the same precision in conventional analysis, four times the number of repetitions would be necessary.

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OLIVEIRA, C. J. B., L. F. O. S. CARVALHO e T. B. GARCIA. "Experimental airborne transmission ofSalmonellaAgona andSalmonellaTyphimurium in weaned pigs". Epidemiology and Infection 134, n.º 1 (17 de junho de 2005): 199–209. http://dx.doi.org/10.1017/s0950268805004668.

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SUMMARYThis study tested the hypothesis of airborne transmission ofSalmonellaAgona (Trial I) andSalmonellaTyphimurium (Trial II) in weaned pigs. The trials were performed using stainless-steel/glass isolation cabinets connected by air ducts to permit an unidirectional airflow from cabinet 1 (two control pigs) to cabinet 3 (two sentinel pigs), passing through cabinet 2 (two inoculated pigs). Air samples, pooled faecal samples from the floor and rectal swabs were collected daily and assessed by culture and PCR. A fumigation chamber and rubber gloves coupled to the cabinets allowed sampling without opening the system. Trials I and II lasted 15 and 19 days respectively. The recovery ofS. Agona andS. Typhimurium and detection of seroconversion in sentinel pigs indicate that airborneSalmonellatransmission in weaned pigs over short distances is possible. Further studies on the role of aerosols in the epidemiology ofSalmonellain intensive pig production should be performed.

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Tinè, Fabio, Massimo Attanasio, Vito M. R. Muggeo e Ciprian M. Crainiceanu. "Evidence of bias in randomized clinical trials of hepatitis C interferon therapies". Clinical Trials 14, n.º 5 (1 de julho de 2017): 483–88. http://dx.doi.org/10.1177/1740774517715447.

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Introduction: Bias may occur in randomized clinical trials in favor of the new experimental treatment because of unblinded assessment of subjective endpoints or wish bias. Using results from published trials, we analyzed and compared the treatment effect of hepatitis C antiviral interferon therapies experimental or control. Methods: Meta-regression of trials enrolling naïve hepatitis C virus patients that underwent four therapies including interferon alone or plus ribavirin during past years. The outcome measure was the sustained response evaluated by transaminases and/or hepatitis C virus-RNA serum load. Data on the outcome across therapies were collected according to the assigned arm (experimental or control) and to other trial and patient-level characteristics. Results: The overall difference in efficacy between the same treatment labeled experimental or control had a mean of +11.9% (p < 0.0001). The unadjusted difference favored the experimental therapies of group IFN-1 (+6%) and group IFN-3 (+10%), while there was no difference for group IFN-2 because of success rates from large multinational trials. In a meta-regression model with trial-specific random effects including several trial and patient-level variables, treatment and arm type remained significant (p < 0.0001 and p = 0.0009 respectively) in addition to drug-schedule-related variables. Conclusion: Our study indicates the same treatment is more effective when labeled “experimental” compared to when labeled “control” in a setting of trials using an objective endpoint and even after adjusting for patient and study-level characteristics. We discuss several factors related to design and conduct of hepatitis C trials as potential explanations of the bias toward the experimental treatment.

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Schüklenk, Udo, e Carlton Hogan. "Patient Access to Experimental Drugs and AIDS Clinical Trial Designs: Ethical Issues". Cambridge Quarterly of Healthcare Ethics 5, n.º 3 (1996): 400–409. http://dx.doi.org/10.1017/s0963180100007209.

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Today's clinical AIDS research is in trouble. Principal investigators are confronted with young and frequently highly knowledgeable patients. Many of these people with AIDS (PWAs) are often unwilling to adhere to the trial protocols. These PWAs believe they are ethically justified in breaching trial protocols because they do not consider themselves true volunteers in such trials. PWAs argue that they do not really volunteer because existing legislation prevents them from buying and using experimental drugs or from testing alternative treatment strategies. Their only access to such agents is participation in clinical trials.

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Xu, Wenfu, Feifang Hu e Siu Hung Cheung. "Adaptive Designs for Non-inferiority Trials with Multiple Experimental Treatments". Statistical Methods in Medical Research 27, n.º 11 (1 de março de 2017): 3255–70. http://dx.doi.org/10.1177/0962280217695579.

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The increase in the popularity of non-inferiority clinical trials represents the increasing need to search for substitutes for some reference (standard) treatments. A new treatment would be preferred to the standard treatment if the benefits of adopting it outweigh a possible clinically insignificant reduction in treatment efficacy (non-inferiority margin). Statistical procedures have recently been developed for treatment comparisons in non-inferiority clinical trials that have multiple experimental (new) treatments. An ethical concern for non-inferiority trials is that some patients undergo the less effective treatments; this problem is more serious when multiple experimental treatments are included in a balanced trial in which the sample sizes are the same for all experimental treatments. With the aim of giving fewer patients the inferior treatments, we propose a response-adaptive treatment allocation scheme that is based on the doubly adaptive biased coin design. The proposed adaptive design is also shown to be superior to the balanced design in terms of testing power.

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Talbot, George H., Maureen Skros e Mary Provencher. "70% Alcohol Disinfection of Transducer Heads: Experimental Trials". Infection Control 6, n.º 6 (junho de 1985): 237–39. http://dx.doi.org/10.1017/s0195941700061609.

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AbstractWe investigated the feasibility of transducer head disinfection with 70% alcohol wipes. In the initial trial, nine gas-sterilized transducers were inoculated with an estimated 5 × 106 organisms of a clinical isolate of Enterobacter cloacae, mimicking a contaminated fluid couple. A sterile disposable transducer dome was attached to each transducer. The units were allowed to sit for 24 hours at room temperature; the domes were then removed. Three transducer heads were cultured prior to disinfection to ensure that viable organisms remained. Each transducer head was wiped clean with a single alcohol wipe, allowed to dry, and then cultured. All nine cultures showed growth of E. cloacae. A second series of trials with 54 transducers employed an identical protocol, except that each transducer head received not one, but two, applications of alcohol. In addition to E. cloacae (26 runs), Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans were employed in nine, nine and ten runs, respectively. Cultures of 53 of 54 transducer heads showed no growth; the single positive culture was attributed to an error in technique. These preliminary results suggest that the double-alcohol-wipe technique may be an easy, cost-effective, alternative or supplemental method of transducer head disinfection. However, we do not advocate routine implementation of this technique in patient care settings until clinical trials confirm its safety and efficacy.

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Fisher, Dwight S. "Defining the experimental unit in grazing trials". Journal of Animal Science 77, E-Suppl (2000): 1. http://dx.doi.org/10.2527/jas2000.00218812007700es0006x.

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Naficy, A. B., J. D. Clemens e M. R. Rao. "Randomized controlled clinical trials of experimental vaccines". Bulletin de l'Institut Pasteur 95, n.º 4 (outubro de 1997): 187–96. http://dx.doi.org/10.1016/s0020-2452(97)83527-1.

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Sprenger, Jan. "Evidence and Experimental Design in Sequential Trials". Philosophy of Science 76, n.º 5 (dezembro de 2009): 637–49. http://dx.doi.org/10.1086/605818.

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Cooper, M. "Experimental Labour--Offshoring Clinical Trials to China". East Asian Science, Technology and Society 2, n.º 1 (1 de janeiro de 2008): 73–92. http://dx.doi.org/10.1215/s12280-008-9040-y.

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Cooper, Melinda. "Experimental Labour—Offshoring Clinical Trials to China". East Asian Science, Technology and Society: an International Journal 2, n.º 1 (março de 2008): 73–92. http://dx.doi.org/10.1007/s12280-008-9040-y.

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Reintgen, Douglas, Jeanne Becker e Hilliard F. Seigler. "Experimental trials of immunotherapy for malignant melanoma". Seminars in Surgical Oncology 7, n.º 4 (julho de 1991): 192–98. http://dx.doi.org/10.1002/ssu.2980070404.

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Logvinov, Ilana. "Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act". Contemporary Clinical Trials 37, n.º 2 (março de 2014): 219–24. http://dx.doi.org/10.1016/j.cct.2014.01.001.

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Mohamed, Mohamed, David Carty, John Storr, Nicola Zuelli, Paul Blackwell e David Savings. "Feasibility Study of Complex Sheet Hydroforming Process: Experimental and Modelling". Key Engineering Materials 716 (outubro de 2016): 685–91. http://dx.doi.org/10.4028/www.scientific.net/kem.716.685.

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The application of finite element method (FEM) in the area of metal forming and material processing has significantly increased in the recent years. The presented study provides details of the development of a finite element modelling approach to form a part via sheet hydroforming (SHF) process. Both FEM analysis and experimental trials were introduced in this study to produce a complex shape component from Inconel 718 material. The FEM provides a robust feasibility study for forming this part in terms of blank design, load path and process design optimisation. The simulated hydroformed part was validated by performing experimental trials. The analysis demonstrated close correlation between the predicted FE model and the physical trial.

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Schellinger, Terri, e John Beer. "Passive Viewing of the Necker Cube during Massed and Distributed Practice". Perceptual and Motor Skills 76, n.º 1 (fevereiro de 1993): 31–34. http://dx.doi.org/10.2466/pms.1993.76.1.31.

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Of 24 students from a psychology class in high school 12 were randomly assigned to a Massed Practice group (4 boys, 8 girls each) and 12 to a Distributed Practice group. They viewed a Necker cube for a 3-min. trial on three occasions separated by a week. The Massed Practice group had no rests while the Distributed Practice group rested 1 min. after each 1 min. of viewing. There were no significant differences for total reversals between Massed and Distributed groups on any trial. There were no significant differences between boys and girls on Trials 1 and 2, but on Trial 3 boys reported significantly more reversals than girls. Within each group there was a significant increase in the number of reversals from Trial 1 to Trial 3, indicating learning effects. Rigidity scores did not correlate significantly with the total Necker cube reversals for Trials 1, 2, or 3. The massed and distributed practice effects were not present although learning was noted. Longer rests may be needed for practice effects within trials; long rests of 7 days between trials may account for lack of differences.

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Byrd, Ronald, e Melvin Gibson. "Bilateral Transfer in Mentally Retarded Children of Ages 7 to 17 Years". Perceptual and Motor Skills 66, n.º 1 (fevereiro de 1988): 115–19. http://dx.doi.org/10.2466/pms.1988.66.1.115.

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The purpose of this study was to describe the effect of age on bilateral transfer of mildly mentally retarded girls (IQs of 70 to 90) after practice on a 45-rpm rotary pursuit task. Subjects were 96 girls from 7 to 17 yr. old. Each performed 14 trials on a rotary pursuit task (30-sec. trials, 10 sec. between trials), half performing the first seven trials with the nonpreferred hand, using the preferred hand on the next seven trials. The order was reversed for the remaining subjects. Nonsignificant differences between Trial 1 scores of the two groups indicated that the task was novel. Trial 1 scores of both groups were positively associated with age ( r = 0.5). There was no transfer to preferred hand, with negative transfer occurring to the nonpreferred hand. It was concluded that, for the task used in this study, mentally retarded girls do not experience positive bilateral transfer as do normal, age-matched girls.

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Gill, David M., John R. Reddon, William O. Stefanyk e Harinder S. Hans. "Finger Tapping: Effects of Trials and Sessions". Perceptual and Motor Skills 62, n.º 2 (abril de 1986): 675–78. http://dx.doi.org/10.2466/pms.1986.62.2.675.

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18 normal, self-reported dextral subjects (9 men, 9 women) were assessed with a Halstead Manual Finger Tapping device, with 10 trials per hand for 10 consecutive wk. The test-retest reliability of the 10-trial average between the 10 sessions averaged .94 for men and .86 for women, for both preferred and nonpreferred hands. There were DO statistically significant effects of increases in performance over sessions or effects of fatigue over trials for either sex or hand. There were, however, significant increases over trials for men for both preferred and nonpreferred hands.

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Al-Harthy, Ibrahim S. "Prediction Accuracy: The Role of Feedback in 6th Graders’ Recall Predictions". International Education Studies 9, n.º 3 (25 de fevereiro de 2016): 212. http://dx.doi.org/10.5539/ies.v9n3p212.

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<p class="apa">The current study focused on the role of feedback on students’ prediction accuracy (calibration). This phenomenon has been widely studied, but questions remain about how best to improve it. In the current investigation, fifty-seven students from sixth grade were randomly assigned to control and experimental groups. Thirty pictures were chosen from the curriculum and these were the same in the trials for both groups, 10 for each trial. The pilot study showed all pictures had the same difficulty level and that they were appropriate for 6<sup>th</sup> graders. During three trials, students in the experimental group received feedback about their prediction and recall. The purpose of the feedback was to assist students in monitoring their learning. Results demonstrated that students in the experimental group showed improvement in predication and prediction accuracy in trials 2 and 3. Significant differences were found among groups in trials 2 and 3, but not in trial 1. Implications and future studies are recommended.</p>

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Peppercorn, J., S. Joffe, H. J. Burstein e E. Winer. "Use of experimental therapy outside of clinical trials among U.S. oncologists". Journal of Clinical Oncology 24, n.º 18_suppl (20 de junho de 2006): 6047. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.6047.

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6047 Background: Investigational cancer therapies being tested in clinical trials may be available outside of trials, or “off-protocol” (OPRx). There are no published data on either the frequency of OPRx or the attitudes of physicians towards OPRx. Methods: In spring 2005, we surveyed a random sample of American medical oncologists chosen from the ASCO directory regarding their attitudes and practices surrounding OPRx. We evaluated the correlation between demographic factors, attitudes, use of OPRx, and response to hypothetical cases. All statistical tests were two-sided. Results: 146 of 471 (31%) oncologists responded. 93% reported ever discussing OPRx and 81% ever prescribing OPRx. 66% reported prescribing OPRx ≥ once/year and 12% ≥ once/month. 68% reported denying requests for OPRx ≥ once/year and 6% ≥ once/month. Academic oncologists were simultaneously more likely than community oncologists to have ever provided OPRx (89% v. 75%, p = 0.06 by Fisher’s exact test), to discuss OPRx ≥ 1 month (45% v. 12%, p = .003), and to deny requests for OPRx ≥ 1 month (15% v. 2%, p = 0.02). While 61% of oncologists believe that patients should be discouraged from OPRx, only 31% felt it should not be available. 53% felt that patients considering trial enrollment should be informed if OPRx is available, whereas 34% disagreed. 26% felt that patients considering enrollment have a right to OPRx, whereas 56% disagreed. Neither practice setting nor other demographic factors predicted attitudes towards OPRx. For hypothetical cases, there was little consensus regarding when to prescribe OPRx. For example, prior to the release of data from recent trials, 41% reported that they would prescribe adjuvant trastuzumab OPRx at a patient’s request. Factors correlating with willingness to provide OPRx included non-academic practice setting (p = 0.04), > 15 years in practice (p = 0.08), belief that non-trial care and trial care are equivalent (p = 0.01) and belief that patients have a right to OPRx (p = 0.004). Conclusion: American oncologists commonly discuss and provide OPRx. Attitudes towards and utilization of OPRx vary substantially in the oncology community. Further discussion of OPRx and guideline development appear warranted. No significant financial relationships to disclose.

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Schaefeer, Sarah A., Lynn A. Darby, Kathy D. Browder e Brenda D. Reeves. "Perceived Exertion and Metabolic Responses of Women during Aerobic Dance Exercise". Perceptual and Motor Skills 81, n.º 2 (outubro de 1995): 691–700. http://dx.doi.org/10.1177/003151259508100265.

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The relationship between ratings of perceived exertion (RPE) and metabolic responses was examined during aerobic dance exercise with combined arm and leg movements. 16 women with previous aerobic dance instructional experience performed three consecutive trials of 8 min. each of aerobic dance exercise at a cadence of 124 and 138 beats • min.-1 Estimates of RPE reported at the end of each trial were significantly different across the trials while heart rate and % maximum heart rate were significantly different between Trials 1 and 3. Correlations and partial correlations between RPE and all metabolic variables were not significant across trials and with trials combined except for ventilation. Results indicated that RPE should not be used singularly as an indicator of exercise intensity during aerobic dance exercise.

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Fleming, Thomas R., Philip R. Krause, Martha Nason, Ira M. Longini e Ana-Maria M. Henao-Restrepo. "COVID-19 vaccine trials: The use of active controls and non-inferiority studies". Clinical Trials 18, n.º 3 (3 de fevereiro de 2021): 335–42. http://dx.doi.org/10.1177/1740774520988244.

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Background: Recently emerging results from a few placebo-controlled randomized trials of COVID-19 vaccines revealed estimates of 62%–95% relative reductions in risk of virologically confirmed symptomatic COVID-19 disease, over approximately 2-month average follow-up period. Additional safe and effective COVID-19 vaccines are needed in a timely manner to adequately address the pandemic on an international scale. Such safe and effective vaccines would be especially appealing for international deployment if they also have favorable stability, supply, and potential for implementation in mass vaccination campaigns. Randomized trials provide particularly reliable insights about vaccine efficacy and safety. While enhanced efficiency and interpretability can be obtained from placebo-controlled trials, in settings where their conduct is no longer possible, randomized non-inferiority trials may enable obtaining reliable evaluations of experimental vaccines through direct comparison with active comparator vaccines established to have worthwhile efficacy. Methods: The usual objective of non-inferiority trials is to reliably assess whether the efficacy of an experimental vaccine is not unacceptably worse than that of an active control vaccine previously established to be effective, likely in a placebo-controlled trial. This is formally achieved by ruling out a non-inferiority margin identified to be the minimum threshold for what would constitute an unacceptable loss of efficacy. This article not only investigates non-inferiority margins, denoted by δ, that address the usual objective of determining whether the experimental vaccine is “at least similarly effective to” the active comparator vaccine in the non-inferiority trial, but also develops non-inferiority margins, denoted by δo, intended to address the worldwide need for multiple safe and effective vaccines by satisfying the less stringent requirement that the experimental vaccine be “at least similarly effective to” an active comparator vaccine having efficacy that satisfies the widely accepted World Health Organization–Food and Drug Administration criteria for “worthwhile” vaccine efficacy. Results: Using the margin δ enables non-inferiority trials to reliably evaluate experimental vaccines that truly are similarly effective to an active comparator vaccine having any level of “worthwhile” efficacy. When active comparator vaccines have efficacy in the range of 50%–70%, non-inferiority trials designed to use the margin δo have appealing properties, especially for experimental vaccines having true efficacy of approximately 60%. Conclusion: Non-inferiority trials using the proposed margins may enable reliable randomized evaluations of efficacy and safety of experimental COVID-19 vaccines. Such trials often require approximately two- to three-fold the person-years follow-up than a placebo-controlled trial. This could be achieved, without substantive increases in sample size, by increasing the average duration of follow-up from 2 months to approximately 4–6 months, assuming efficacy of the active comparator vaccine has been reliably evaluated over that longer duration.

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Croce, Ronald, Michael Horvat e Glenn Roswal. "Augmented Feedback for Enhanced Skill Acquisition in Individuals with Traumatic Brain Injury". Perceptual and Motor Skills 82, n.º 2 (abril de 1996): 507–14. http://dx.doi.org/10.2466/pms.1996.82.2.507.

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Coincident timing by individuals who exhibit traumatic brain injury was measured under conditions of no knowledge of results (no KR; n = 12), KR on every trial ( n = 14), summary KR ( n = 13), and average KR ( n = 12). Following acquisition trials, groups performed immediate and longer retention trials without KR. Absolute constant error and variable error, analyzed in separate repeated-measures analyses of variance, indicated that during acquisition trials subjects receiving KR on every trial were the most accurate and the most consistent in their responses; however, subjects in groups receiving summary and average KR were the most accurate during immediate retention, with the group receiving summary KR being the most accurate during longer retention.

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Montazer, M. Ali, e John G. Thomas. "Grip Strength as a Function of 200 Repetitive Trials". Perceptual and Motor Skills 75, n.º 3_suppl (dezembro de 1992): 1320–22. http://dx.doi.org/10.2466/pms.1992.75.3f.1320.

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A study was done to see how grip strength deteriorates after an extended number of grips. Eight male subjects, all right-handed and 23 to 35 years old, participated. Each subject made 200 grips on a dynamometer at his maximum strength. There were 15-sec. rests between trials. Performance dropped significantly after two trials. There were drops of about 40% and 50% at Trials 100 and 200, respectively. The grip strength/trial relationship is logarithmic as noted by Montazer and Thomas in 1991.

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Reddon, John R., William O. Stefanyk, David M. Gill e Caroline Renney. "Hand Dynamometer: Effects of Trials and Sessions". Perceptual and Motor Skills 61, n.º 3_suppl (dezembro de 1985): 1195–98. http://dx.doi.org/10.2466/pms.1985.61.3f.1195.

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12 normal, self-reported dextral subjects (6 men, 6 women) were assessed with a hand dynamometer with 10 trials per hand for 10 consecutive wk. The test-retest reliability of the 10-trial average across the 10 sessions averaged .91 for men and .94 for women for both preferred and non-preferred hands. Fatigue effects over trials were statistically significant for both sexes and hands except for women's preferred hand. Skill acquisition effects over sessions were only statisically significant for men's nonpreferred and women's preferred hands.

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McPeek, Bucknam, Frederick Mosteller e Martin McKneally. "Randomized Clinical Trials in Surgery". International Journal of Technology Assessment in Health Care 5, n.º 3 (julho de 1989): 317–32. http://dx.doi.org/10.1017/s026646230000739x.

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When it is well conducted, a randomized clinical provides the strongest evidence available for evaluating the comparative effectiveness of the interventions tested. Over the last two generations, we have learned much about various devices for strengthening them and about methods of avoiding between in their design, execution, analysis, and reporting. In a trial, we seek evidence for a causal link between treatment and observed outcomes. Becaues the controlled trial depends on an argument based on exculsion (i.e., no other causes or differences affected the experimental groups), we strengthen its inference by taking steps to exclude any such differences.This article discusses a number of issues that deserve consideration: problems of multiplicity and generalizability, devices for strengthening trials, issues of power and sample size, the relationship between study design and reported gains, when to undertake a trial, the role of collaborative trials, and ways to make trials more feasible in clinical settings.

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Chugh, Rashmi. "Experimental Therapies and Clinical Trials in Bone Sarcoma". Journal of the National Comprehensive Cancer Network 8, n.º 6 (junho de 2010): 715–25. http://dx.doi.org/10.6004/jnccn.2010.0052.

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Sarcomas originating in the bone represent a challenge for physicians and patients. Because they constitute only 0.2% of all adult malignancies and 6% of pediatric malignancies, resources for studying this disease are often limited.1,2 Nonetheless, significant advancements have been made in the treatment of this disease, and there are ongoing efforts toward improvement. This article discusses recently completed and currently enrolling clinical trials for the 3 most common bone sarcomas: osteosarcoma, Ewing's sarcoma family tumors, and chondrosarcoma.

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NAKAMURA, Takehiro, Anass BENJEBBOUR, Yoshihisa KISHIYAMA, Satoshi SUYAMA e Tetsuro IMAI. "5G Radio Access: Requirements, Concept and Experimental Trials". IEICE Transactions on Communications E98.B, n.º 8 (2015): 1397–406. http://dx.doi.org/10.1587/transcom.e98.b.1397.

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Tadokoro, Yasuho. "The Experimental Trials against “the Chattonella Red Tide”". Japan journal of water pollution research 12, n.º 4 (1989): 225–29. http://dx.doi.org/10.2965/jswe1978.12.225.

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Guénette, Chantal C., Gary A. Sergy, Edward H. Owens, Roger C. Prince e Kenneth Lee. "Experimental design of the Svalbard shoreline field trials". Spill Science & Technology Bulletin 8, n.º 3 (junho de 2003): 245–56. http://dx.doi.org/10.1016/s1353-2561(03)00038-0.

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Uchida, E., T. Aimoto, Y. Nakamura, K. Cho, M. Hiroi, M. Kawamoto, T. Tajiri, T. Ishiwata e Z. Naito. "HAMSTER PANCREATIC CANCER MODEL FOR EXPERIMENTAL THERAPEUTIC TRIALS". Pancreas 35, n.º 4 (novembro de 2007): 431–32. http://dx.doi.org/10.1097/01.mpa.0000297800.73046.b9.

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Fayers, Peter M. "Randomization in clinical trials and experimental molecular medicine". Molecular Medicine Today 2, n.º 9 (setembro de 1996): 366–68. http://dx.doi.org/10.1016/s1357-4310(96)20023-1.

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Nemeth, Balazs T., Zoltan V. Varga, Wen Jin Wu e Pal Pacher. "Trastuzumab cardiotoxicity: from clinical trials to experimental studies". British Journal of Pharmacology 174, n.º 21 (25 de novembro de 2016): 3727–48. http://dx.doi.org/10.1111/bph.13643.

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Katsileros, Anastasios, e Christos Koukouvinos. "Evaluation of experimental designs in durum wheat trials". Biometrical Letters 52, n.º 2 (1 de dezembro de 2015): 105–14. http://dx.doi.org/10.1515/bile-2015-0010.

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Abstract Variability among experimental plots may be a relevant problem in field genotype experiments, especially when a large number of entries are involved. Four field trials on 24 durum wheat genotypes were conducted in 2013/14 in order to evaluate the efficiency of Incomplete Block, Alpha and Augmented designs in comparison with the traditional Randomized Complete Block Design (RCBD). The results showed that the RCBD can be replaced by an Alpha design, which provides better control of variability among the experimental units when the number of treatments to be tested in an experiment exceeds twenty. The ranking of the genotypes across the four designs was not constant.

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Bellin, Eran. "Non-Placebo Controlled HIV Experimental Trials in Prisoners". Journal of Acquired Immune Deficiency Syndromes & Human Retrovirology 9, n.º 3 (julho de 1995): 315. http://dx.doi.org/10.1097/00042560-199507000-00019.

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Varghese, Cini, Eldho Varghese, Seema Jaggi e Arpan Bhowmik. "Experimental designs for open pollination in polycross trials". Journal of Applied Statistics 42, n.º 11 (15 de maio de 2015): 2478–84. http://dx.doi.org/10.1080/02664763.2015.1043860.

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Bivens, Heather, e Burton Slotnick. "Decrement in the Horizontal–Vertical Illusion: Are Subjects Aware of Their Increased Accuracy?" Perceptual and Motor Skills 90, n.º 2 (abril de 2000): 403–12. http://dx.doi.org/10.2466/pms.2000.90.2.403.

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47 subjects adjusted the extended vertical lines of 20 inverted-T figures to make them appear equal to a horizontal line and rated the confidence in their accuracy after each trial. One group viewed figures of varying sizes, a second group viewed figures of standard size, and a third group viewed figures of standard size but received feedback on their accuracy immediately after completing Trial 5. Except for a significant increase in accuracy on Trial 6 for the Feedback Group, there were no differences in performance among groups. Subjects made the vertical line significantly shorter than the horizontal line on initial trials but their accuracy improved over trials. In contrast, there was no consistent increase in confidence, and several analyses indicated that confidence ratings were unrelated to accuracy. These results suggest that the subjects were unaware of the decrement in illusion that occurred over trials.

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Schwertner, Diogo V., Alessandro D. Lúcio e Alberto Cargnelutti Filho. "Size of uniformity trials for estimating the optimum plot size for vegetables". Horticultura Brasileira 33, n.º 3 (setembro de 2015): 388–93. http://dx.doi.org/10.1590/s0102-053620150000300019.

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The aim of this work was to determine the uniformity trial size for estimating the optimum plot size in order to evaluate the fruit mass of tomato, snap-beans and zucchini. The mass of fruits was evaluated in uniformity trials with tomato grown in plastic tunnel in spring-summer and autumn-winter seasons, with snap-beans in plastic greenhouse in autumn-winter season and, with zucchini in plastic greenhouse in summer-autumn and winter-spring seasons. These data were used for planning different sizes of uniformity trials and resampling with replacement was used to estimate the optimum plot size by the method of maximum curvature of the coefficient of variation model. The size of uniformity trials influences the estimation of the optimum plot size for evaluating the mass of fruits of tomato, snap-beans and zucchini. Uniformity trials with tomato with 12 basic experimental units (12 plants) and with snap-beans with 21 basic experimental units (42 plants) are enough for estimating the optimum plot size for evaluating the mass of fruits in plastic tunnel with a confidence interval of 95% minor or equal to two basic experimental units. Uniformity trials with snap-beans with 18 basic experimental units (36 plants) and with zucchini with ten basic experimental units (ten plants) in plastic greenhouse are enough for estimating the optimum plot size for evaluating the mass of fruits with a confidence interval of 95% minor or equal to three basic experimental units.

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Tsao, Jennie CI, Subhadra Evans, Laura C. Seidman e Lonnie K. Zeltzer. "Experimental Pain Responses in Children with Chronic Pain and in Healthy Children: How Do They Differ?" Pain Research and Management 17, n.º 2 (2012): 103–9. http://dx.doi.org/10.1155/2012/592108.

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BACKGROUND: Extant research comparing laboratory pain responses of children with chronic pain with healthy controls is mixed, with some studies indicating lower pain responsivity for controls and others showing no differences. Few studies have included different pain modalities or assessment protocols.OBJECTIVES: To compare pain responses among 26 children (18 girls) with chronic pain and matched controls (mean age 14.8 years), to laboratory tasks involving thermal heat, pressure and cold pain. Responses to cold pain were assessed using two different protocols: an initial trial of unspecified duration and a second trial of specified duration.METHODS: Four trials of pressure pain and of thermal heat pain stimuli, all of unspecified duration, were administered, as well as the two cold pain trials. Heart rate and blood pressure were assessed at baseline and after completion of the pain tasks.RESULTS: Pain tolerance and pain intensity did not differ between children with chronic pain and controls for the unspecified trials. For the specified cold pressor trial, 92% of children with chronic pain completed the entire trial compared with only 61.5% of controls. Children with chronic pain exhibited a trend toward higher baseline and postsession heart rate and reported more anxiety and depression symptoms compared with control children.CONCLUSIONS: Contextual factors related to the fixed trial may have exerted a greater influence on pain tolerance in children with chronic pain relative to controls. Children with chronic pain demonstrated a tendency toward increased arousal in anticipation of and following pain induction compared with controls.

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