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Sample records for random clinical trial

  1. [Controlled randomized clinical trials].

    Science.gov (United States)

    Jaillon, Patrice

    2007-01-01

    It is generally agreed that the first comparative clinical trial in history was done by James Lind in 1747, in the treatment of scurvy. The general bases of modern experimental medicine were published by Claude Bernard in 1865. However, it is the development of new drugs and the evolution of methodological concepts that led to the first randomized controlled clinical trial, in 1948, which showed that the effects of streptomycin on pulmonary tuberculosis were significantly different from those of a placebo. Today, "evidence-based" medicine aims to rationalize the medical decision-making process by taking into account, first and foremost, the results of controlled randomized clinical trials, which provide the highest level of evidence. In the second half of the 20th century it became clear that different kinds of clinical trials might not provide the same level of evidence. Practitioners' intimate convictions must be challenged by the results of controlled clinical trials. Take the CAST trial for example, which, in 1989, tested antiarrhythmic drugs versus placebo in patients with myocardial infarction. It was well known that ventricular arrhythmias were a factor of poor prognosis in coronary heart disease, and it was therefore considered self-evident that drug suppression of these ventricular arrhythmias would reduce the mortality rate. In the event, the CAST trial showed the exact opposite, with an almost 3-fold increase in total mortality among patients with coronary heart disease who were treated with antiarrhythmic drugs. These results had a profound impact on the use of antiarrythmic drugs, which became contraindicated after myocardial infarction. A clinical trial has to fulfill certain methodological standards to be accepted as evidence-based medicine. First, a working hypothesis has to be formulated, and then the primary outcome measure must be chosen before beginning the study. An appropriate major endpoint for efficacy must be selected, in keeping with the

  2. Registration of randomized clinical trials

    DEFF Research Database (Denmark)

    Østervig, R M; Sonne, A; Rasmussen, L S

    2015-01-01

    starting enrolment before 2010 to 63.2% after 2010 (24/38, P clinical trials were registered at clinicaltrials.gov. CONCLUSION: Many published randomized controlled trials from Acta Anaesthesiologica Scandinavica were not adequately registered but the requirement of trial registration has...... the proportion of correctly registered randomized controlled trials (RCTs) published in Acta from 2009 to 2014. METHODS: We manually searched all Acta issues from 2009 to 2014 for RCTs. Information about timing of data collection and registration in trial registries was extracted. We classified RCTs as correctly...... registered when it could be verified that patient enrolment was started after registration in a trial registry. RESULTS: We identified 200 RCTs. Dates for patient enrolment were not specified in 51 (25.5%). The proportion of correctly registered trials increased significantly from 17.1% (19/111) for trials...

  3. Randomized clinical trial

    DEFF Research Database (Denmark)

    Kiszka-Kanowitz, Marianne; Theede, Klaus; Mertz-Nielsen, Anette

    2016-01-01

    remission rates and lower incidence of adverse events. AIM: To compare the rates of clinical remission and the rates of adverse events in IBD patients treated with either standard treatment with azathioprine or low-dose azathioprine in combination with allopurinol. METHODS: A prospective, open-label study...... to treat analysis and found a significant (69.6%) proportion of the patients treated with low-dose azathioprine in combination with allopurinol was in clinical remission without the need for steroid or biologic treatment at week 24 compared to 34.7% of the patients treated with azathioprine monotherapy (RR...

  4. Randomized clinical trials in HEPATOLOGY

    DEFF Research Database (Denmark)

    Kjaergard, L L; Nikolova, D; Gluud, C

    1999-01-01

    Evidence shows that the quality of randomized clinical trials (RCTs) affects estimates of intervention efficacy, which is significantly exaggerated in low-quality trials. The present study examines the quality of all 235 RCTs published in HEPATOLOGY from the initiation in 1981 through August 1998......-blinding. The median quality score of all trials was 3 points (range, 1-5 points). Multiple logistic regression analysis explored the association between quality and therapeutic areas, number of centers, external funding, year of publication, and country of origin. High-quality trials were most likely to investigate......, single-center trials, and trials with no external funding. Quality did not improve with time and was not associated with country of origin. The main conclusions are that the quality of RCTs in HEPATOLOGY needs improvement and that the probability of high quality increased with the number of centers...

  5. Randomized Clinical Trials in Stroke Research

    OpenAIRE

    Ahn, Chul; Ahn, Daniel

    2010-01-01

    A randomized clinical trial (RCT) is widely regarded as the most rigorous study design to determine the efficacy of intervention since spurious causality and bias associated with other experimental designs can be avoided. The purpose of this article is to provide clinicians and clinical researchers with the types of randomized clinical trials used in stroke studies and to discuss the advantages and limitations in each type of randomized stroke clinical trials.

  6. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly...

  7. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...

  8. Randomized Clinical Trials With Biomarkers: Design Issues

    Science.gov (United States)

    McShane, Lisa M.; Korn, Edward L.

    2010-01-01

    Clinical biomarker tests that aid in making treatment decisions will play an important role in achieving personalized medicine for cancer patients. Definitive evaluation of the clinical utility of these biomarkers requires conducting large randomized clinical trials (RCTs). Efficient RCT design is therefore crucial for timely introduction of these medical advances into clinical practice, and a variety of designs have been proposed for this purpose. To guide design and interpretation of RCTs evaluating biomarkers, we present an in-depth comparison of advantages and disadvantages of the commonly used designs. Key aspects of the discussion include efficiency comparisons and special interim monitoring issues that arise because of the complexity of these RCTs. Important ongoing and completed trials are used as examples. We conclude that, in most settings, randomized biomarker-stratified designs (ie, designs that use the biomarker to guide analysis but not treatment assignment) should be used to obtain a rigorous assessment of biomarker clinical utility. PMID:20075367

  9. Blinding in randomized clinical trials: imposed impartiality

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Boutron, I

    2011-01-01

    Blinding, or "masking," is a crucial method for reducing bias in randomized clinical trials. In this paper, we review important methodological aspects of blinding, emphasizing terminology, reporting, bias mechanisms, empirical evidence, and the risk of unblinding. Theoretical considerations...... and empirical analyses support the blinding of patients, health-care providers, and outcome assessors as to the trial intervention to which patients have been allocated. We encourage extensive pretrial testing of blinding procedures and explicit reporting of who was in the blinded condition and the methods used...

  10. Dynamic randomization and a randomization model for clinical trials data.

    Science.gov (United States)

    Kaiser, Lee D

    2012-12-20

    Randomization models are useful in supporting the validity of linear model analyses applied to data from a clinical trial that employed randomization via permuted blocks. Here, a randomization model for clinical trials data with arbitrary randomization methodology is developed, with treatment effect estimators and standard error estimators valid from a randomization perspective. A central limit theorem for the treatment effect estimator is also derived. As with permuted-blocks randomization, a typical linear model analysis provides results similar to the randomization model results when, roughly, unit effects display no pattern over time. A key requirement for the randomization inference is that the unconditional probability that any patient receives active treatment is constant across patients; when this probability condition is violated, the treatment effect estimator is biased from a randomization perspective. Most randomization methods for balanced, 1 to 1, treatment allocation satisfy this condition. However, many dynamic randomization methods for planned unbalanced treatment allocation, like 2 to 1, do not satisfy this constant probability condition, and these methods should be avoided. Copyright © 2012 John Wiley & Sons, Ltd.

  11. [Ethical aspects of randomized clinical trials].

    Science.gov (United States)

    Bartoli, E; Sorrentino, D; Trevisi, A

    1997-01-01

    Randomized clinical trials represent the final, essential link between basic medical research and human health. However, their conduction presents very complex ethical problems, since the patient is the actual target of the experiment. Proper randomization, informed consent, and preliminary disclosure of results create deep ethical conflicts between the role of caretaker and that of impartial observer, both played by the same doctor. The dilemma reproduces the conflict between two different ethics. One is based on the inalienable individual rights stemming from the concept of man as an end in himself and not a means to an end. The other, derived from utilitarian philosophies, is based on the benefit for society as a whole. If we agree that randomized clinical trials represent the best method to test the validity of a new treatment, there is no easy solution. The dilemma could be solved by separating the role of the family doctor, committed to the best treatment possible for his patient, from the role of the scientist, committed to the progress of science and humanity. The former is involved in the treatment of individual patients, the latter in clinical and scientific experiments of a therapeutic nature. The patient may trade his rights to the best possible cure for the safety and the efficiency guaranteed by the scientific institution conducting the trial. Trials on relevant issues--expected to produce important results and impeccably designed scientifically--could be endowed with the ethics of science per se and this could be considered equivalent to the individual rights waived by the patient.

  12. Empirical likelihood inference in randomized clinical trials.

    Science.gov (United States)

    Zhang, Biao

    2017-01-01

    In individually randomized controlled trials, in addition to the primary outcome, information is often available on a number of covariates prior to randomization. This information is frequently utilized to undertake adjustment for baseline characteristics in order to increase precision of the estimation of average treatment effects; such adjustment is usually performed via covariate adjustment in outcome regression models. Although the use of covariate adjustment is widely seen as desirable for making treatment effect estimates more precise and the corresponding hypothesis tests more powerful, there are considerable concerns that objective inference in randomized clinical trials can potentially be compromised. In this paper, we study an empirical likelihood approach to covariate adjustment and propose two unbiased estimating functions that automatically decouple evaluation of average treatment effects from regression modeling of covariate-outcome relationships. The resulting empirical likelihood estimator of the average treatment effect is as efficient as the existing efficient adjusted estimators(1) when separate treatment-specific working regression models are correctly specified, yet are at least as efficient as the existing efficient adjusted estimators(1) for any given treatment-specific working regression models whether or not they coincide with the true treatment-specific covariate-outcome relationships. We present a simulation study to compare the finite sample performance of various methods along with some results on analysis of a data set from an HIV clinical trial. The simulation results indicate that the proposed empirical likelihood approach is more efficient and powerful than its competitors when the working covariate-outcome relationships by treatment status are misspecified.

  13. Randomized clinical trial: group counseling based on tinnitus retraining therapy

    National Research Council Canada - National Science Library

    Henry, James A; Loovis, Carl; Montero, Melissa; Kaelin, Christine; Anselmi, Kathryn-Anne; Coombs, Rebecca; Hensley, June; James, Kenneth E

    2007-01-01

    .... We conducted a randomized clinical trial to test the hypothesis that group educational counseling based on TRT principles would effectively treat veterans who have clinically significant tinnitus...

  14. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  15. Perspectives on randomized clinical trials : the case for albuminuria

    NARCIS (Netherlands)

    Lambers Heerspink, Hiddo Jan

    2008-01-01

    Large scale randomized clinical trials are needed to detect small but meaningful effects of new drugs. However, large scale randomized clinical trials are expensive undertakings and they are in imbalance with the scientific output. As a consequence there is a strong voice for more efficacious

  16. Randomized clinical trial of laparoscopic versus open appendicectomy

    DEFF Research Database (Denmark)

    Pedersen, Allan Gorm; Petersen, O B; Wara, P

    2001-01-01

    BACKGROUND: Laparoscopy in patients with a clinical suspicion of acute appendicitis has not gained wide acceptance, and its use remains controversial. METHODS: In a randomized controlled trial of laparoscopic versus open appendicectomy, 583 of 828 consecutive patients consented to participate...

  17. Quality assessment of randomized clinical trial in intensive care.

    Science.gov (United States)

    Gonçalves, Giulliano Peixoto; Barbosa, Fabiano Timbó; Barbosa, Luciano Timbó; Duarte, José Lira

    2009-03-01

    A randomized clinical trial is a prospective study that compares the effect and value of interventions in human beings, of one or more groups vs. a control group. The objective of this study was to evaluate the quality of published randomized clinical trials in Intensive care in Brazil. All randomized clinical trials in intensive care found by manual search in Revista Brasileira de Terapia Intensiva from January 2001 to March 2008 were assessed to evaluate their description by the quality scale. Descriptive statistics and a 95 % confidence interval were used for the primary outcome. Our primary outcome was the randomized clinical trial quality. Our search found 185 original articles, of which 14 were randomized clinical trials. Only one original article (7.1%) showed good quality. There was no statistical significance between the collected data and the data shown in the hypothesis of this search. It can be concluded that in the sample of assessed articles 7% of the randomized clinical trials in intensive care published in a single intensive care journal in Brazil, present good methodological quality.

  18. An Update on Randomized Clinical Trials in Breast Cancer.

    Science.gov (United States)

    Barnard, Kayla; Klimberg, V Suzanne

    2017-10-01

    Numerous clinical trials reveal new innovations and therapies that continually change the treatment and prevention of breast cancer. Earlier trials have changed the standard of care from radical mastectomy to breast conservation therapy and individualized treatment based on tumor-specific biology. As research continues and long-term follow-up results become available, updated reviews on randomized clinics trials become exceedingly important in discerning the most effective and oncologically safe therapies to provide optimal outcomes. Published by Elsevier Inc.

  19. Randomized Clinical Trials on Deep Carious Lesions

    DEFF Research Database (Denmark)

    Bjørndal, Lars; Fransson, Helena; Bruun, Gitte

    2017-01-01

    nonselective carious removal to hard dentin with or without pulp exposure. The aim of this article was to report the 5-y outcome on these previously treated patients having radiographically well-defined carious lesions extending into the pulpal quarter of the dentin but with a well-defined radiodense zone...... between the carious lesion and the pulp. In this long-term study, 239 of 314 (76.2%) patients were analyzed. The stepwise removal group had a significantly higher proportion of success (60.2%) at 5-y follow-up compared with the nonselective carious removal to hard dentin group (46.3%) (P = 0.031) when......) in deep carious lesions in adults. In conclusion, the stepwise carious removal group had a significantly higher proportion of pulps with sustained vitality without apical radiolucency versus nonselective carious removal of deep carious lesions in adult teeth at 5-y follow-up (ClinicalTrials.gov NCT...

  20. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2013-01-01

    conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...

  1. Fool's gold, lost treasures, and the randomized clinical trial.

    Science.gov (United States)

    Stewart, David J; Kurzrock, Razelle

    2013-04-16

    Randomized controlled trials with a survival endpoint are the gold standard for clinical research, but have failed to achieve cures for most advanced malignancies. The high costs of randomized clinical trials slow progress (thereby causing avoidable loss of life) and increase health care costs. A malignancy may be caused by several different mutations. Therapies effective vs one mutation may be discarded due to lack of statistical significance across the entire population. Conversely, expensive large randomized trials may have sufficient statistical power to demonstrate benefit despite the therapy only working in subgroups. Non-cost-effective therapy is then applied to all patients (including subgroups it cannot help). Randomized trials comparing therapies with different mechanisms of action are misleading since they may conclude the therapies are "equivalent" despite benefitting different subpopulations, or may erroneously conclude that one therapy is superior simply because it targets a larger subpopulation. Furthermore, minor variances in patient selection may determine study outcome, a therapy may be discarded as ineffective despite substantial benefit in one subpopulation if harmful in another, randomized trials may more effectively detect therapies with minor benefit in most patients vs marked benefit in subpopulations, and randomized trials in unselected patients may erroneously conclude that "shot-gun" combinations are superior to single agents when sequential administration of personalized single agents might work better and spare patients treatment with drugs that cannot help them. We must identify predictive biomarkers early by comparing responding to progressing patients in phase I-II trials. Enriching randomized trials for biomarker-positive patients can markedly reduce required patient numbers and costs despite expensive screening for biomarker-positive patients. Available data support approval of new drugs without randomized trials if they yield

  2. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...... provided for subjective outcome: (1) dependent on assessor judgment, (2) patient-reported outcome, or (3) private phenomena (ie, phenomena only assessable by the patient). Of the 200 clinical trial reports, 12 used the term "subjective" and/or "objective" about outcomes, but no clinical trial reports...

  3. The conduct and principles of randomized clinical trials.

    Science.gov (United States)

    Klimt, C R

    1981-05-01

    Some of the guiding principles as well as the pitfall of long-term randomized clinical trials are presented. Examples have been chosen from trials in the cardiovascular field. A typical long-term clinical trial is divided into five phases: planning, preparation, recruitment, clinical follow-up and termination, and finally analysis. Administrative, legal, and ethical aspects of a trial are discussed, as well as the cost of clinical trials. Organization patterns are described and some prevalent ones are criticized. Further, practical matters such as recruitment techniques, obtaining informed consent from the patients, determining drug dosage and formulation as well as the problem of interaction with nonstudy drugs are referred to. Adherence testing remains a problem, because of our inability to test for placebo adherence.

  4. Citation bias of hepato-biliary randomized clinical trials

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Gluud, Christian

    2002-01-01

    The objective of this study was to assess whether trials with a positive (i.e., statistically significant) outcome are cited more often than negative trials. We reviewed 530 randomized clinical trials on hepato-biliary diseases published in 11 English-language journals indexed in MEDLINE from 1985......-1996. From each trial, we extracted the statistical significance of the primary study outcome (positive or negative), the disease area, and methodological quality (randomization and double blinding). The number of citations during two calendar years after publication was obtained from Science Citation Index...... that positive trials are cited significantly more often than negative trials. The association was not explained by disease area or methodological quality....

  5. Fundamentals of randomized clinical trials in wound care

    DEFF Research Database (Denmark)

    Eskes, Anne M; Brölmann, Fleur E; Sumpio, Bauer E

    2012-01-01

    acknowledged as the study design of choice for comparing treatment effects, as they eliminate several sources of bias. We propose a framework for the design and conduct of future randomized clinical trials that will offer strong scientific evidence for the effectiveness of wound care interventions. While......The care for chronic and acute wounds is a substantial problem around the world. This has led to a plethora of products to accelerate healing. Unfortunately, the quality of studies evaluating the efficacy of such wound care products is frequently low. Randomized clinical trials are universally....... This article proposes strategies for improving the evidence base for wound care decision making....

  6. Project Management of Randomized Clinical Trials: A Narrative Review.

    Science.gov (United States)

    Goodarzynejad, Hamidreza; Babamahmoodi, Abdolreza

    2015-08-01

    A well-structured protocol for a clinical trial may be able to answer clinical questions, but it cannot be deemed enough to ensure success in the face of incompetent management of time as well as human and economic resources. To address this problem, in this article, we present our literature review on evidence as to how a good knowledge of proper management among researchers can enhance the likelihood of the success of clinical trial projects. Using multiple search strategies, we conducted a literature review on published studies in the English language from 2002 to 2012 by searching the Cochrane Database of Systematic Reviews, MEDLINE, Google Scholar, and EMBASE. Our review suggests that a successful trial requires a work plan or work scope as well as a timeline. The trial manager should subsequently manage the study in accordance with the plan and the timeline. Many research units have called for a clinical project manager with scientific background and regulatory skills to effect coordination among various aspects of a clinical trial. Project management may benefit both the managerial and scientific aspects of medical projects and reduce fund waste. However, little has been written to date on project management in the context of clinical research. The suggestions represent the views of the individual authors. To provide a high level of evidence in this regard, we recommend that a randomized controlled trial be performed to compare trial projects progressed with and without the use of project management.

  7. RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

    Science.gov (United States)

    Malavolta, Eduardo Angeli; Demange, Marco Kawamura; Gobbi, Riccardo Gomes; Imamura, Marta; Fregni, Felipe

    2015-01-01

    Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery. PMID:27027037

  8. Blinded trials taken to the test: an analysis of randomized clinical trials that report tests for the success of blinding

    DEFF Research Database (Denmark)

    Hróbjartsson, A; Forfang, E; Haahr, M T

    2007-01-01

    Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful.......Blinding can reduce bias in randomized clinical trials, but blinding procedures may be unsuccessful. Our aim was to assess how often randomized clinical trials test the success of blinding, the methods involved and how often blinding is reported as being successful....

  9. Randomized Clinical Trial of Interceptive and Comprehensive Orthodontics

    Science.gov (United States)

    King, G.J.; Spiekerman, C.F.; Greenlee, G.M.; Huang, G.J.

    2012-01-01

    Focusing public insurance programs on interceptive orthodontics (IO) may increase access for low-income children. This report presents outcomes from a randomized clinical trial (RCT) comparing IO with comprehensive orthodontics (CO) in Medicaid patients. One hundred seventy pre-adolescents with Medicaid-eligible malocclusions were randomized to IO (n = 86) followed by observation (OBS) or OBS followed by CO (n = 84). One hundred thirty-four completed the trial. Models at pre-treatment (baseline) and following ≤ 2 years of intervention and 2 years of OBS (48 mos) were scored by calibrated examiners using the Peer Assessment Rating (PAR) and Index of Complexity, Outcome and Need (ICON). Overall outcomes and clinically meaningful categorical ICON data on need/acceptability, complexity, and improvement were compared. At baseline, groups were balanced by age, gender, ethnicity, and PAR/ICON scores. Most were minorities. Most (77%) were rated as difficult-to-very difficult. Scores improved significantly for both groups, but CO more than IO (PAR, 18.6 [95%CI 15.1, 22.1] vs.10.1 [95%CI 6.7, 13.4]; ICON, 44.8 [95% CI 39.7, 49.9] vs. 35.2 [95%CI 29.7, 40.6], respectively). On average, IO is effective at reducing malocclusions in Medicaid patients, but less than CO. (ClinicalTrials.gov number CT00067379) PMID:22699670

  10. Event detection using population-based health care databases in randomized clinical trials

    DEFF Research Database (Denmark)

    Thuesen, Leif; Jensen, Lisette Okkels; Tilsted, Hans Henrik

    2013-01-01

    To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials.......To describe a new research tool, designed to reflect routine clinical practice and relying on population-based health care databases to detect clinical events in randomized clinical trials....

  11. Effects of auriculotherapy on labour pain: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Reginaldo Roque Mafetoni

    Full Text Available Abstract OBJECTIVE Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. METHOD This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. RESULTS No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes; caesarean section rates were higher in the placebo group (50% and the same in the other groups (10%. CONCLUSION Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj.

  12. Magnesium treatment in alcoholics: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Poikolainen Kari

    2008-01-01

    Full Text Available Abstract Background Magnesium (Mg deficiency is common among alcoholics. Earlier research suggests that Mg treatment may help to normalize elevated enzyme activities and some other clinically relevant parameters among alcoholics but the evidence is weak. Methods The effect of Mg was studied in a randomized, parallel group, double-blind trial. The patients were first treated for alcohol withdrawal symptoms and then received for 8 weeks either 500 mg of Mg divided into two tablets or matching placebo. Measurements were made at the beginning and in the end of the Mg treatment period. The primary outcome was serum gamma-glutamyltransferase (S-GGT activity; secondary outcomes included aspartate-aminotransferase (S-AST and alanine-aminotransferase (S-ALT activity. Results The number of randomized patients (completers was 64 (27 in the treatment and 54 (31 in the control group. In intention-to-treat-analyses and in most analyses of study completers, there were no significant differences between the Mg-treated and placebo groups in the outcome variables. When baseline serum Mg level, coffee intake, and the number of unused Mg tablets were controlled for in a multivariate regression model, after-treatment serum Mg levels were found to be higher among the Mg-treated group than in the placebo group (t-test 3.334, df = 53, p = 0.002. After controlling for age, body weight, baseline alcohol intake, subsequent change in alcohol intake and baseline S-AST, the after-treatment S-AST levels were found to be lower among the Mg-treated group than in the placebo group (t-test 2.061, df = 49, p = 0.045. Conclusion Mg treatment may speed up the S-AST decrease in compliant patients. This might decrease the risk of death from alcoholic liver disease. Trial Registration ClinicalTrials.gov ID NCT00325299

  13. Design Issues in Randomized Clinical Trials of Maintenance Therapies.

    Science.gov (United States)

    Freidlin, Boris; Little, Richard F; Korn, Edward L

    2015-11-01

    A potential therapeutic strategy for patients who respond (or have stable disease) on a fixed-duration induction therapy is to receive maintenance therapy, typically given for a prolonged period of time. To enable patients and clinicians to make informed treatment decisions, the designs of phase III randomized clinical trials (RCTs) assessing maintenance strategies need to be such that their results will provide clear assessment of the relevant risks and benefits of these strategies. We review the key aspects of maintenance RCT designs. Important design considerations include choice of first-line and second-line therapies, minimizing between-arm differences in follow-up schedules, and choice of the primary endpoint. In order to change clinical practice, RCTs should be designed to accurately isolate and quantify the clinical benefit of maintenance as compared with the standard approach of fixed-duration induction followed by the second-line treatment at progression. To accomplish this, RCTs need to utilize an overall survival (or quality of life) endpoint or, in settings where this is not feasible, endpoints that incorporate the effects of the subsequent line of therapy (eg, time from randomization to second progression or death). Toxicity and symptom information over both the study treatment (maintenance) and the second-line treatment should also be collected and reported. Published by Oxford University Press 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.

  14. Fluoride concentration from dental sealants: a randomized clinical trial.

    Science.gov (United States)

    Campus, G; Carta, G; Cagetti, M G; Bossù, M; Sale, S; Cocco, F; Conti, G; Nardone, M; Sanna, G; Strohmenger, L; Lingström, P

    2013-07-01

    A randomized clinical trial was performed in schoolchildren (6-7 yrs) to evaluate fluoride concentration in interproximal fluid after the placement of 3 different sealants. The sample consisted of 2,776 children randomly divided: 926 in the high-viscosity Glass-ionomer Cement group (GIC group), 923 in the fluoride Resin-based group (fluoride-RB group), and 927 in the no-fluoride Resin-based group (RB group). In total, 2,640 children completed the trial. Sealants were applied following manufacturer's instructions. Interproximal fluid samples were collected at baseline and 2, 7, and 21 days after application of sealants, by insertion of a standardized paperpoint into the interproximal mesial space of the sealed tooth for 15 seconds. Fluoride concentration was evaluated by means of a fluoride ion-selective electrode. At 2 days after sealant application, fluoride concentration was significantly higher in GIC and fluoride-RB groups compared with that in the RB group (p sealants increased the fluoride concentrations in interproximal fluid more than did a Resin-based sealant containing fluoride.

  15. Exergaming and older adult cognition: a cluster randomized clinical trial.

    Science.gov (United States)

    Anderson-Hanley, Cay; Arciero, Paul J; Brickman, Adam M; Nimon, Joseph P; Okuma, Naoko; Westen, Sarah C; Merz, Molly E; Pence, Brandt D; Woods, Jeffrey A; Kramer, Arthur F; Zimmerman, Earl A

    2012-02-01

    Dementia cases may reach 100 million by 2050. Interventions are sought to curb or prevent cognitive decline. Exercise yields cognitive benefits, but few older adults exercise. Virtual reality-enhanced exercise or "exergames" may elicit greater participation. To test the following hypotheses: (1) stationary cycling with virtual reality tours ("cybercycle") will enhance executive function and clinical status more than traditional exercise; (2) exercise effort will explain improvement; and (3) brain-derived neurotrophic growth factor (BDNF) will increase. Multi-site cluster randomized clinical trial (RCT) of the impact of 3 months of cybercycling versus traditional exercise, on cognitive function in older adults. Data were collected in 2008-2010; analyses were conducted in 2010-2011. 102 older adults from eight retirement communities enrolled; 79 were randomized and 63 completed. A recumbent stationary ergometer was utilized; virtual reality tours and competitors were enabled on the cybercycle. Executive function (Color Trails Difference, Stroop C, Digits Backward); clinical status (mild cognitive impairment; MCI); exercise effort/fitness; and plasma BDNF. Intent-to-treat analyses, controlling for age, education, and cluster randomization, revealed a significant group X time interaction for composite executive function (p=0.002). Cybercycling yielded a medium effect over traditional exercise (d=0.50). Cybercyclists had a 23% relative risk reduction in clinical progression to MCI. Exercise effort and fitness were comparable, suggesting another underlying mechanism. A significant group X time interaction for BDNF (p=0.05) indicated enhanced neuroplasticity among cybercyclists. Cybercycling older adults achieved better cognitive function than traditional exercisers, for the same effort, suggesting that simultaneous cognitive and physical exercise has greater potential for preventing cognitive decline. This study is registered at Clinicaltrials.gov NCT01167400. Copyright

  16. Validity of randomized clinical trials in gastroenterology from 1964-2000

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

    2002-01-01

    The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

  17. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

    Science.gov (United States)

    Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

    2012-07-01

    Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

  18. Fundamentals of randomized clinical trials in wound care

    DEFF Research Database (Denmark)

    Brölmann, Fleur E; Eskes, Anne M; Sumpio, Bauer E

    2013-01-01

    . Randomized clinical trials (RCTs) are universally acknowledged as the study design of choice for comparing treatment effects. To give high-level evidence the appreciation it deserves in wound care, we propose a step-by-step reporting standard for comprehensive and transparent reporting of RCTs in wound care......In wound care research, available high-level evidence according to the evidence pyramid is rare, and is threatened by a poor study design and reporting. Without comprehensive and transparent reporting, readers will not be able to assess the strengths and limitations of the research performed....... Critical reporting issues (e.g., wound care terminology, blinding, predefined outcome measures, and a priori sample size calculation) and wound-specific barriers (e.g., large diversity of etiologies and comorbidities of patients with wounds) that may prevent uniform implementation of reporting standards...

  19. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The Info Trial Group

    DEFF Research Database (Denmark)

    Kruse, A Y; Kjaergard, L L; Krogsgaard, K

    2000-01-01

    To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... the total attitude score (4.8 points) and the randomized clinical trials attitude subscale score (1.8 points). In conclusion, written information significantly improved outpatients' knowledge about and attitude toward randomized clinical trials. Detailed rather than brief information was more effective...

  20. Decision Aids Can Support Cancer Clinical Trials Decisions: Results of a Randomized Trial.

    Science.gov (United States)

    Politi, Mary C; Kuzemchak, Marie D; Kaphingst, Kimberly A; Perkins, Hannah; Liu, Jingxia; Byrne, Margaret M

    2016-12-01

    Cancer patients often do not make informed decisions regarding clinical trial participation. This study evaluated whether a web-based decision aid (DA) could support trial decisions compared with our cancer center's website. Adults diagnosed with cancer in the past 6 months who had not previously participated in a cancer clinical trial were eligible. Participants were randomized to view the DA or our cancer center's website (enhanced usual care [UC]). Controlling for whether participants had heard of cancer clinical trials and educational attainment, multivariable linear regression examined group on knowledge, self-efficacy for finding trial information, decisional conflict (values clarity and uncertainty), intent to participate, decision readiness, and trial perceptions. Two hundred patients (86%) consented between May 2014 and April 2015. One hundred were randomized to each group. Surveys were completed by 87 in the DA group and 90 in the UC group. DA group participants reported clearer values regarding trial participation than UC group participants reported (least squares [LS] mean = 15.8 vs. 32, p trial participation among cancer patients facing this preference-sensitive choice. Although better informing patients before trial participation could improve retention, more work is needed to examine DA impact on enrollment and retention. This paper describes evidence regarding a decision tool to support patients' decisions about trial participation. By improving knowledge, helping patients clarify preferences for participation, and facilitating conversations about trials, decision aids could lead to decisions about participation that better match patients' preferences, promoting patient-centered care and the ethical conduct of clinical research. ©AlphaMed Press.

  1. Publication of sports medicine-related randomized controlled trials registered in ClinicalTrials.gov.

    Science.gov (United States)

    Chahal, Jaskarndip; Tomescu, S Sebastian; Ravi, Bheeshma; Bach, Bernard R; Ogilvie-Harris, Darrell; Mohamed, Nizar N; Gandhi, Rajiv

    2012-09-01

    There is increasing evidence that a significant proportion of randomized trials in medicine, and recently in orthopaedics, do not go on to publication. The objectives of this study were (1) to determine publication rates of randomized controlled trials in sports medicine that have been registered with ClinicalTrials.gov (CTG) and (2) to compare the registration summaries of randomized trials on CTG with final published manuscripts on pertinent methodological variables. Systematic review. Two independent investigators searched ClinicalTrials.gov for all closed and completed trials related to sports medicine until June 2009 using a text search strategy. The authors then searched for publications resulting from these registered trials in peer-reviewed journals that are indexed with MEDLINE and/or EMBASE as of February 2012 based on study authors and key words provided in the study protocol. Details of primary outcomes and secondary outcomes, study sponsors, and sample size were extracted and compared between registrations and publications. Of 34 closed and completed trials registered on CTG, there were 20 resultant publications in peer-reviewed journals (58.8%). There was no significant relationship between source of funding and rate of publication (P > .05). The authors found a discrepancy between the CTG registration summary and the manuscript in at least one methodological variable (primary/secondary outcomes, inclusion/exclusion criteria, sample size) in 16 of 20 (80.0%) articles and a discrepancy in the primary outcome in 8 of 20 (40.0%) published trials. Although registration of sports medicine trials in CTG does not consistently result in publication or disclosure of results at 32 months from the time of study completion, observed publication rates are higher than in other orthopaedic subspecialties. Changes are also frequently made to the final presentation of eligibility criteria and primary and secondary outcomes that are not reflected in the registered

  2. Use of Recursive Partitioning Analysis in Clinical Trials and Meta-Analysis of Randomized Clinical Trials, 1990-2016.

    Science.gov (United States)

    Fors, Martha Maria; Viada, Carmen Elena; Gonzalez, Paloma

    2017-01-01

    Recursive Partitioning Analysis (RPA) is a very flexible non parametric algorithm that allows classification of individuals according to certain criteria, particularly in clinical trials, the method is used to predict response to treatment or classify individuals according to prognostic factors. In this paper we examine how often RPA is used in clinical trials and in meta-analysis. We reviewed abstracts published between 1990 and 2016, and extracted data regarding clinical trial phase, year of publication, type of treatment, medical indication and main evaluated endpoints. One hundred and eighty three studies were identified; of these 43 were meta-analyses and 23 were clinical trials. Most of the studies were published between 2011 and 2016, for both clinical trials and meta-analyses of randomized clinical trials. The prediction of overall survival and progression free survival were the outcomes most evaluated, at 43.5% and 51.2% respectively. Regarding the use of RPA in clinical trials, the brain was the most common site studied, while for meta-analytic studies, other cancer sites were also studied. The combination of chemotherapy and radiation was seen frequently in clinical trials. Recursive partitioning analysis is a very easy technique to use, and it could be a very powerful tool to predict response in different subgroups of patients, although it is not widely used in clinical trials. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  3. A note on Harold S. Diehl, randomization, and clinical trials.

    Science.gov (United States)

    Waller, L A

    1997-04-01

    Harold S. Diehl and coworkers published results from a remarkable trial on the efficacy of vaccines for the common cold in 1938. The original report states that patients were assigned to treatment and control groups "at random." Diehl's study has been referred to as one of the first instances of a randomized, double-blind, placebo-controlled trial. No description of a formal randomization scheme is given in the 1938 report and an unpublished paper of Diehl's suggests the use of alternate assignment in the study.

  4. Computerized Tool to Manage Dental Anxiety: A Randomized Clinical Trial.

    Science.gov (United States)

    Tellez, M; Potter, C M; Kinner, D G; Jensen, D; Waldron, E; Heimberg, R G; Myers Virtue, S; Zhao, H; Ismail, A I

    2015-09-01

    Anxiety regarding dental and physical health is a common and potentially distressing problem, for both patients and health care providers. Anxiety has been identified as a barrier to regular dental visits and as an important target for enhancement of oral health-related quality of life. The study aimed to develop and evaluate a computerized cognitive-behavioral therapy dental anxiety intervention that could be easily implemented in dental health care settings. A cognitive-behavioral protocol based on psychoeducation, exposure to feared dental procedures, and cognitive restructuring was developed. A randomized controlled trial was conducted (N = 151) to test its efficacy. Consenting adult dental patients who met inclusion criteria (e.g., high dental anxiety) were randomized to 1 of 2 groups: immediate treatment (n = 74) or a wait-list control (n = 77). Analyses of covariance based on intention-to-treat analyses were used to compare the 2 groups on dental anxiety, fear, avoidance, and overall severity of dental phobia. Baseline scores on these outcomes were entered into the analyses as covariates. Groups were equivalent at baseline but differed at 1-mo follow-up. Both groups showed improvement in outcomes, but analyses of covariance demonstrated significant differences in dental anxiety, fear, avoidance, and overall severity of dental phobia in favor of immediate treatment at the follow-up assessment. Of the patients who met diagnostic criteria for phobia at baseline, fewer patients in the immediate treatment group continued to meet criteria for dental phobia at follow-up as compared with the wait-list group. A new computer-based tool seems to be efficacious in reducing dental anxiety and fear/avoidance of dental procedures. Examination of its effectiveness when administered in dental offices under less controlled conditions is warranted (ClinicalTrials.gov NCT02081365). © International & American Associations for Dental Research.

  5. Myopia Control with Bifocal Contact Lenses: A Randomized Clinical Trial.

    Science.gov (United States)

    Aller, Thomas A; Liu, Maria; Wildsoet, Christine F

    2016-04-01

    Most studies have reported only minimal reductions in myopia progression with bifocal or progressive multifocal spectacles, although somewhat larger, although mostly still clinically insignificant, effects have been reported in children with nearpoint esophoria and/or accommodative dysfunctions. The CONTROL study was a 1-year, prospective, randomized, clinical trial of bifocal contact lenses for control of myopia in children with eso fixation disparities at near. Eighty-six myopic subjects, aged 8 to 18 years, were enrolled in the study after passing the screening examination. Of these, 79 completed lens assignment and 78 completed the study. The mean refractive error of these 79 subjects was -2.69 ± 1.40D (SD), and all had progressed by -0.50D or more since their last examination. All subjects also had eso fixation disparity at near. Subjects were randomly assigned to wear either Vistakon Acuvue 2 (single-vision soft contact lenses [SVSCLs]) or Vistakon Acuvue Bifocal (bifocal soft contact lenses [BFSCLs]). Bifocal adds were selected to neutralize the associated phoria. Treatment outcomes included cycloplegic autorefraction and axial length, assessed in terms of changes after 6 and 12 months of treatment from pretreatment baseline values. The BFSCLs significantly slowed myopia progression, with statistically significant differences between the treatment groups after 6 months. After 12 months of treatment, the SVSCL group had progressed by -0.79 ± 0.43D compared with -0.22 ± 0.34D for the BFSCL group (cycloplegic objective spherical equivalent, average of two eyes). Corresponding axial length changes were 0.24 ± 0.17 mm and 0.05 ± 0.14 mm, respectively. All of these differences were found to be statistically significant (unpaired t-tests, p 70%) compared with most published results with multifocal spectacles. Further studies are warranted to identify the critical factors and mechanisms underlying this myopia control effect.

  6. Effects of auriculotherapy on labour pain: a randomized clinical trial.

    Science.gov (United States)

    Mafetoni, Reginaldo Roque; Shimo, Antonieta Keiko Kakuda

    2016-01-01

    Assessing the effects of auriculotherapy in pain control and its outcomes on the duration of labour. This is a randomized, controlled, double-blind trial with preliminary data. Thirty pregnant women with gestational age ≥ 37 weeks, cervical dilatation ≥ 4 cm and two or more contractions in 10 minutes were selected and randomly divided into three groups: auriculotherapy, placebo and control. Auriculotherapy was applied using crystal beads on four strategic points. No statistical significance was found between the groups with regard to pain; however, the women from the auriculotherapy group had lower intensity and less perception of pain at 30, 60 and 120 minutes of treatment. The average duration of labour was shorter in the auriculotherapy group (248.7 versus placebo 414.8 versus control 296.3 minutes); caesarean section rates were higher in the placebo group (50%) and the same in the other groups (10%). Mothers who received auriculotherapy presented a tendency for greater pain control and shorter labour duration; however, caesarean section rates in this group were similar to the control group. This trial precedes a larger study in progress. Registration of Brazilian Clinical Trials: RBR-47hhbj. Avaliar os efeitos da auriculoterapia no controle da dor e seus desfechos na duração do trabalho de parto. Trata-se de um ensaio controlado, randomizado e duplo-cego, com dados preliminares. Foram selecionadas 30 parturientes com idade gestacional ≥ 37 semanas, dilatação cervical ≥ 4 cm e duas ou mais contrações em 10 minutos, divididas aleatoriamente em três grupos: auriculoterapia, placebo ou controle. A auriculoterapia foi aplicada com microesferas de cristais em quatro pontos estratégicos. Não houve significância estatística entre os grupos com relação à dor; no entanto, as mulheres do grupo de auriculoterapia, apresentaram menor intensidade e menor percepção da dor aos 30, 60 e 120 minutos do tratamento. A média de duração do trabalho de

  7. A randomized clinical trial of treatment for lumbar segmental rigidity.

    Science.gov (United States)

    Mayer, Tom G; Gatchel, Robert J; Keeley, Janice; McGeary, Don; Dersh, Jeffrey; Anagnostis, Christopher

    2004-10-15

    A randomized single-blind clinical trial of facet injections plus exercise, versus exercise alone, in chronic disabling work-related lumbar spinal disorders (CDWRLSD), accompanied by pilot interrater reliability and facet syndrome prevalence studies. To systematically investigate the use of facet injections as an adjunct to supervised lumbar stretching exercises in regaining lumbar range of motion (ROM) following prolonged deconditioning after work-related lumbar injuries. To assess interrater reliability of visual assessment of segmental rigidity (SR), and to evaluate the prevalence of facet syndrome in cases of lumbar SR. Corticosteroid joint injections have often been used to reduce musculoskeletal inflammation to facilitate joint mobilization in the presence of degenerative arthritis. Lumbar segmental rigidity is a recently described entity usually associated with painful chronic spinal disorders and postoperative spine surgery. Previous work has shown that SR and lumbar ROM improves with a brief intervention consisting of facet injections followed by specific stretching exercises. No systematic study has investigated the potential benefits of a combination of facet injections and exercise over supervised exercises alone to treat lumbar SR. Similarly, no study has assessed the association between SR and the facet syndrome. From a group of consecutive patients (n = 421) with CDWRLSD referred for tertiary rehabilitation between November 1999 and January 2001, 70 were noted to have SR on intake physical examination. The first part of this study assessed interrater reliability for detecting SR, and intrarater reliability for 3-segment true lumbar ROM measurements. Patients randomly assigned to participate in supervised stretching exercises with the addition of fluoroscopically guided bilateral facet injections at the involved levels (Group A, n = 36) also underwent facet syndrome prevalence assessment at the time of injection. They were compared to a randomly

  8. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized...... clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...

  9. Weight loss therapy for clinical management of patients with some atherosclerotic diseases: a randomized clinical trial

    OpenAIRE

    Oshakbayev, Kuat; Dukenbayeva, Bibazhar; Otarbayev, Nurzhan; Togizbayeva, Gulnar; Tabynbayev, Nariman; Gazaliyeva, Meruyert; Idrisov, Alisher; Oshakbayev, Pernekul

    2015-01-01

    Background The prevalence and burden of atherosclerotic (AS) diseases are increasing during the last twenty years. Some studies show a close relationship between overweight and AS, but influence on AS diseases of different weight loss methods are still studying. The purpose of the research was to study the effectiveness of a weight loss program in AS patients in randomized controlled trial, and to develop a conception of evolution of AS. Methods A randomized controlled prospective clinical tr...

  10. The pursuit of balance: An overview of covariate-adaptive randomization techniques in clinical trials.

    Science.gov (United States)

    Lin, Yunzhi; Zhu, Ming; Su, Zheng

    2015-11-01

    Randomization is fundamental to the design and conduct of clinical trials. Simple randomization ensures independence among subject treatment assignments and prevents potential selection biases, yet it does not guarantee balance in covariate distributions across treatment groups. Ensuring balance in important prognostic covariates across treatment groups is desirable for many reasons. A broad class of randomization methods for achieving balance are reviewed in this paper; these include block randomization, stratified randomization, minimization, and dynamic hierarchical randomization. Practical considerations arising from experience with using the techniques are described. A review of randomization methods used in practice in recent randomized clinical trials is also provided. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. Identifying randomized clinical trials in Spanish-language dermatology journals.

    Science.gov (United States)

    Sanclemente, G; Pardo, H; Sánchez, S; Bonfill, X

    2015-06-01

    The necessary foundation for good clinical practice lies in knowledge derived from clinical research. Evidence from randomized clinical trials (RCTs) is the pillar on which decisions about therapy are based. To search exhaustively and rigorously to identify RCTs in dermatology journals published in Spanish. We located dermatology journals through the following search engines and indexes: PubMed, LILACS, SciELO, Periódica, Latindex, Índice Médico Español, C-17, IBECS, EMBASE, and IMBIOMED. We also sought information through dermatology associations and dermatologists in countries where Spanish was the usual language of publication, and we searched the Internet (Google). Afterwards we searched the journals electronically and manually to identify RCTs in all available volumes and issues, checking from the year publication started through 2012. Of 28 journals identified, we included 21 in the search. We found a total of 144 RCTs published since 1969; 78 (54%) were in Latin American journals and 66 (46%) were in Spanish journals. The most frequent disease contexts for RCTs in Spanish journals were psoriasis, mycoses, and acne vulgaris. In Latin American journals, the most frequent disease contexts were common warts, mycoses, acne vulgaris, and skin ulcers on the lower limbs. Manual searches identified more RCTs than electronic searches. Manual searches found a larger number of RCTs. Relatively fewer RCTs are published in Spanish and Latin American journals than in English-language journals. Internet facilitated access to full texts published by many journals; however, free open access to these texts is still unavailable and a large number of journal issues are still not posted online. Copyright © 2014 Elsevier España, S.L.U. and AEDV. All rights reserved.

  12. Music listening for anxiety relief in children in the preoperative period: a randomized clinical trial

    National Research Council Canada - National Science Library

    Franzoi, Mariana André Honorato; Goulart, Cristina Bretas; Lara, Elizabete Oliveira; Martins, Gisele

    2016-01-01

    ...: randomized controlled clinical trial pilot study with 52 children in the preoperative period, aged 3 to 12 years, undergoing elective surgery and randomly allocated in the experimental group (n = 26) and control group (n = 26...

  13. Infant orthopedics and facial appearance: a randomized clinical trial (Dutchcleft).

    NARCIS (Netherlands)

    Prahl, C.; Prahl-Andersen, B.; Hof, M.A. van 't; Kuijpers-Jagtman, A.M.

    2006-01-01

    OBJECTIVE: To study the effect of infant orthopedics on facial appearance. DESIGN: Prospective two-arm randomized controlled trial in parallel with three participating academic cleft palate centers. Treatment allocation was concealed and performed by means of a computerized balanced allocation

  14. Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

    Science.gov (United States)

    Christopher, Paul P; Appelbaum, Paul S; Truong, Debbie; Albert, Karen; Maranda, Louise; Lidz, Charles

    2017-01-01

    Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials. This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50), and willingness to participate in the clinical trial. 154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017). Willingness to participate in the hypothetical trial was not significantly different (p = 0.603) between intervention (52.1%, 95% CI [40.2% to 62.4%]) and control (56.3%, 95% CI [45.3% to 66.6%] groups. An enhanced educational intervention augmenting

  15. Porcine collagen matrix for treating gingival recession. Randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Yuri Castro

    2014-03-01

    Full Text Available Achieving root coverage after exposure caused by gingival recession is one of the main goals of reconstructive periodontal surgery. Even though a large variety of techniques and mucogingival grafting procedures are available, their long-term results are not clear yet. Therefore, this study aimed to compare clinical effectiveness of the porcine collagen matrix with subepithelial connective graft for treating Miller class I and II gingival recessions. Materials and methods: The randomized clinical trial included twelve patients assigned to two groups. In the first group (experimental, six patients were treated using collagen matrix (mean age, 54.3±5.6 years; mean recession 2. 67±1.03mm. Another group (control of six patients was treated using connective grafts (mean age, 57.1± 2.7 years; mean recession 4.33±1.03mm. All patients underwent periodontal evaluation and pre-surgical preparation including oral hygiene instruction and supragingival scaling. Gingival recessions were exposed through partial thickness flaps where the grafts and matrices were placed. Patients were assessed periodically until complete healing of tissue. Results: Root coverage parameters, amount of keratinized gingiva, gingival biotype and clinical attachment level were evaluated. The root coverage percentage for the group using connective graft was 24.7±13.5% and 16.6±26.8% for the one treated with the matrix. The amount of increased keratinized tissue was 4.33±2.06mm and 4.5±0.83mm for the control and experimental group respectively. Both groups increased gingival biotypes from thin to thick at 100%. The final clinical attachment level was 4.17±3.17±04mm for the control group and 0.98mm for the experimental group. There were significant differences between the outcome of gingival recession and clinical attachment. Conclusion: Results indicate both techniques, besides being predictable, are useful for improving clinical parameters when treating gingival recessions

  16. Yoga decreases insomnia in postmenopausal women: a randomized clinical trial.

    Science.gov (United States)

    Afonso, Rui Ferreira; Hachul, Helena; Kozasa, Elisa Harumi; Oliveira, Denise de Souza; Goto, Viviane; Rodrigues, Dinah; Tufik, Sérgio; Leite, José Roberto

    2012-02-01

    The practice of yoga has been proven to have positive effects on reducing insomnia. Studies have also shown its effects on reducing climacteric symptoms. To date, however, no studies that evaluate the effects of yoga on postmenopausal women with a diagnosis of insomnia in a randomized clinical trial have been conducted. The aim of this study was to evaluate the effect of yoga practice on the physical and mental health and climacteric symptoms of postmenopausal women with a diagnosis of insomnia. Postmenopausal women not undergoing hormone therapy, who were 50 to 65 years old, who had an apnea-hypopnea index less than 15, and who had a diagnosis of insomnia were randomly assigned to one of three groups, as follows: control, passive stretching, and yoga. Questionnaires were administered before and 4 months after the intervention to evaluate quality of life, anxiety and depression symptoms, climacteric symptoms, insomnia severity, daytime sleepiness, and stress. The volunteers also underwent polysomnography. The study lasted 4 months. There were 44 volunteers at the end of the study. When compared with the control group, the yoga group had significantly lower posttreatment scores for climacteric symptoms and insomnia severity and higher scores for quality of life and resistance phase of stress. The reduction in insomnia severity in the yoga group was significantly higher than that in the control and passive-stretching groups. This study showed that a specific sequence of yoga might be effective in reducing insomnia and menopausal symptoms as well as improving quality of life in postmenopausal women with insomnia.

  17. Snoezelen Room and Childbirth Outcome: A Randomized Clinical Trial.

    Science.gov (United States)

    Jamshidi Manesh, Mansoureh; Kalati, Mahnaz; Hosseini, Fatemeh

    2015-05-01

    One of the strategies for a good outcome and pain free childbearing is to design the delivery room. The aim of this study was to evaluate the effects of snoezelen room on childbearing outcome such as pain intensity, duration of labor, and perinea status in nulliparous women. This study was a randomized controlled clinical trial consists of 100 childbearing women. They were randomly divided into 2 groups. The experimental group went to snoezelen room when their cervix dilation was 4 cm, while the control group went to physiologic delivery room with the same cervix dilation. The mean ± SD of VAS (Visual Analogue Scale) pain intensity of the experimental and control groups before the intervention were 5.1 ± 1.95 and 5.58 ± 1.62, respectively (P = 0.13). The mean ± SD of VAS pain intensity scores of the experimental and control groups after 3 hours spending in their assigned rooms were 5.26 ± 0.86 and 9.56 ± 1.48, respectively (P = 0.01). The mean ± SD of the first stage scores of the experimental and control groups were 6.95 ± 0.97 and 8.41 ± 0.67, respectively (P = 0.042). About 92% of participants' intervention vs. 66% of control participants had perinea laceration (P = 0.041). According to the findings of the present study, distracting senses in snoezelen room decreases mother's pain intensity, the length of labor, and incidence of episiotomy.

  18. The impact of data errors on the outcome of randomized clinical trials

    NARCIS (Netherlands)

    Buyse, Marc; Squifflet, Pierre; Coart, Elisabeth; Quinaux, Emmanuel; Punt, Cornelis J. A.; Saad, Everardo D.

    2017-01-01

    Background/aims: Considerable human and financial resources are typically spent to ensure that data collected for clinical trials are free from errors. We investigated the impact of random and systematic errors on the outcome of randomized clinical trials. Methods: We used individual patient data

  19. Review of the randomized clinical stroke rehabilitation trials in 2009

    Science.gov (United States)

    Rabadi, Meheroz H.

    2011-01-01

    Summary Background Recent review of the available evidence on interventions for motor recovery after stroke, showed that improvements in recovery of arm function were seen for constraint-induced movement therapy, electromyographic biofeedback, mental practice with motor imagery, and robotics. Similar improvement in transfer ability or balance were seen with repetitive task training, biofeedback, and training with a moving platform. Walking speed was improved by physical fitness training, high-intensity physiotherapy and repetitive task training. However, most of these trials were small and had design limitations. Material/Methods In this article, randomized control trials (RCT’s) published in 2009 of rehabilitation therapies for acute (≤2 weeks), sub-acute (2 to 12 weeks) and chronic (≥12 weeks) stroke was reviewed. A Medline search was performed to identify all RCT’s in stroke rehabilitation in the year 2009. The search strategy that was used for PubMed is presented in the Appendix 1. The objective was to examine the effectiveness of these treatment modalities in stroke rehabilitation. Results This generated 35 RCT’s under 5 categories which were found and analyzed. The methodological quality was assessed by using the PEDro scale for external and internal validity. Conclusions These trials were primarily efficacy studies. Most of these studies enrolled small numbers of patient which precluded their clinical applicability (limited external validity). However, the constraint induced movement therapy (CIT), regularly used in chronic stroke patients did not improve affected arm-hand function when used in acute stroke patients at ≤4 weeks. Intensive CIT did not lead to motor improvement in arm-hand function. Robotic arm treatment helped decrease motor impairment and improved function in chronic stroke patients only. Therapist provided exercise programs (when self-administered by patients during their off-therapy time in a rehabilitation setting) did improve

  20. Neonatal Resuscitation with an Intact Cord: A Randomized Clinical Trial.

    Science.gov (United States)

    Katheria, Anup; Poeltler, Debra; Durham, Jayson; Steen, Jane; Rich, Wade; Arnell, Kathy; Maldonado, Mauricio; Cousins, Larry; Finer, Neil

    2016-11-01

    To assess whether providing ventilation during delayed cord clamping (V-DCC) increases placental transfusion compared with delayed cord clamping alone (DCC only). Inborn premature infants (230/7-316/7 weeks' gestational age) were randomized to receive at least 60 seconds of V-DCC (initial continuous positive airway pressure) with addition of positive pressure ventilation if needed) or without assisted ventilation (DCC only). For the DCC-only group, infants were dried and stimulated by gently rubbing the back if apneic. The primary outcome was the peak hematocrit in the first 24 hours of life. Delivery room outcomes were analyzed from video recordings and a data acquisition system. Hemodynamic measurements were performed with the use of functional echocardiography, near-infrared spectroscopy, and electrical cardiometry. There was no difference in the primary outcome of peak hematocrit in the first 24 hours of life. The onset of breathing was similar between both groups (25 ± 20 and 27 ± 28 seconds, P = .627); however, infants receiving DCC received a greater duration of stimulation than V-DCC (41 ± 19 and 20 ± 21 seconds P = .002). There were no differences in delivery room interventions, early hemodynamics (cerebral oxygenation by near-infrared spectroscopy, cardiac output and stroke volume by electrical cardiometry, or superior vena cava flow by of functional echocardiography), or neonatal outcomes. V-DCC was feasible but did not lead to any measurable clinical improvements immediately after delivery or reduce subsequent neonatal morbidity. Caretakers should consider providing adequate stimulation before cord clamping. ClinicalTrials.gov: NCT02231411. Copyright © 2016 Elsevier Inc. All rights reserved.

  1. Vascular care in patients with Alzheimer's disease with cerebrovascular lesions-a randomized clinical trial

    NARCIS (Netherlands)

    Richard, Edo; Kuiper, Roy; Dijkgraaf, Marcel G. W.; van Gool, Willem A.

    2009-01-01

    OBJECTIVES: To investigate whether vascular care slows dementia progression in patients with Alzheimer's disease with cerebrovascular lesions on neuroimaging. DESIGN: Multicenter randomized controlled clinical trial with 2-year follow-up. SETTING: Neurological and geriatric outpatient clinics in 10

  2. Kangaroo mother care for infantile colic: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Reza Saeidi

    2010-03-01

    Full Text Available "n Normal 0 false false false EN-US X-NONE AR-SA MicrosoftInternetExplorer4 st1":*{behavior:url(#ieooui } /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat: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:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;} Background: Infantile colic has been defined as episodes of excessive and persistent crying without known medical cause. Kangaroo mother care is a new method for baby care with several advantages. A universally available and biologically sound method of care for all newborns, with three components: skin-to-skin contact, exclusive breastfeeding, support to the mother-infant dyad. This study designed for evaluating Kangaroo mother care on infantile colic.  "n"nMethods: This study was a randomized controlled trial. From 1th may 2008 to 1 may 2009 a total of 70 children, aged 3-12 weeks with persistent colic symptoms were studied. The children were referred to Sheikh clinic, Mashhad, Iran, because of excessive crying. Normal mother-infant pairs were recruited at 3 to 12 weeks of age after obtaining baseline for two days. Subjects divided randomly to kangaroo care or conventional care group and mothers in both groups filled diary for seven days. "n"nResults: In the beginning of the study, the infants in kangaroo care group had 3.5 hr/d crying and after the intervention, it decreased to 1.7 hr/d, the difference were significant (p<0.05. But there were no difference in feeding duration between

  3. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    context of low back pain and post knee replacement surgery pain as compared to standard therapies. As per profile of lornoxicam, if it is better than diclofenac sodium then it will be helpful in managing the patients of osteoarthritis more effectively. Till date no comparative clinical trial has been done to compare these two ...

  4. Acupuncture for Posttraumatic Stress Disorder: A Systematic Review of Randomized Controlled Trials and Prospective Clinical Trials

    Directory of Open Access Journals (Sweden)

    Young-Dae Kim

    2013-01-01

    Full Text Available To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were “acupuncture” and “PTSD.” No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs and 2 uncontrolled clinical trials (UCTs out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs. One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  5. Alzheimer’s disease multiple intervention trial (ADMIT: study protocol for a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Callahan Christopher M

    2012-06-01

    Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared

  6. Cupping therapy for acute and chronic pain management: a systematic review of randomized clinical trials

    OpenAIRE

    Cao, Huijuan; Li, Xun; Yan, Xue; Wang, Nissi S.; Bensoussan, Alan; Liu, Jianping

    2014-01-01

    Objective: Cupping as a traditional therapy is used to treat a myriad of health conditions, including pain. This systematic review assessed the effectiveness and safety of cupping for different types of pain. Methods: Thirteen databases and four trial registries were searched for randomized clinical trials. Meta-analysis of data was conducted if there was non-significant clinical and statistical heterogeneity (measured by I2 test) among trials. Results: Sixteen trials with 921 participa...

  7. The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications

    DEFF Research Database (Denmark)

    Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn

    2014-01-01

    randomized clinical trials indexed in PubMed in 2010. Two authors read the trial publications and extracted data independently. RESULTS: Twenty-four trial publications, or 8% (95% confidence interval [CI], 5, 12%), explicitly reported the risk of unblinding, of which 16 publications, or 5% (95% CI, 3, 8...

  8. Nebulized hypertonic saline for bronchiolitis: a randomized clinical trial.

    Science.gov (United States)

    Wu, Susan; Baker, Chris; Lang, Michael E; Schrager, Sheree M; Liley, Fasha F; Papa, Carmel; Mira, Valerie; Balkian, Ara; Mason, Wilbert H

    2014-07-01

    Bronchiolitis is one of the most common and costly respiratory diseases in infants and young children. Previous studies have shown a potential benefit of nebulized hypertonic saline; however, its effect in the emergency department (ED) setting is unclear. To compare the effect of nebulized 3% hypertonic saline vs 0.9% normal saline on admission rate and length of stay in infants with bronchiolitis. We conducted a double-blind, randomized clinical trial during 3 consecutive bronchiolitis seasons from March 1, 2008, through April 30, 2011. We recruited a convenience sample of patients younger than 24 months with a primary diagnosis of viral bronchiolitis presenting to the ED of 2 urban free-standing tertiary children's hospitals. We excluded patients who were premature (gestational age, saline [HS group]) or 0.9% sodium chloride (normal saline [NS group]) inhaled as many as 3 times in the ED. Those admitted received the assigned medication every 8 hours until discharge. All treatment solutions were premedicated with albuterol sulfate. Hospital admission rate, length of stay for admitted patients, and Respiratory Distress Assessment Instrument score. A total of 197 patients were enrolled in the NS group and 211 in the HS group. Admission rate in the 3% HS group was 28.9% compared with 42.6% in the NS group (adjusted odds ratio from logistic regression, 0.49 [95% CI, 0.28-0.86]). Mean (SD) length of stay for hospitalized patients was 3.92 (5.24) days for the NS group and 3.16 (2.11) days for the HS group (P = .24). The Respiratory Distress Assessment Instrument score decreased after treatment in both groups; however, we found no significant difference between groups (P = .35). Hypertonic saline given to children with bronchiolitis in the ED decreases hospital admissions. We can detect no significant difference in Respiratory Distress Assessment Instrument score or length of stay between the HS and NS groups. clinicaltrials.gov Identifier: NCT00619918.

  9. Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial.

    Science.gov (United States)

    Manfredini, Fabio; Mallamaci, Francesca; D'Arrigo, Graziella; Baggetta, Rossella; Bolignano, Davide; Torino, Claudia; Lamberti, Nicola; Bertoli, Silvio; Ciurlino, Daniele; Rocca-Rey, Lisa; Barillà, Antonio; Battaglia, Yuri; Rapanà, Renato Mario; Zuccalà, Alessandro; Bonanno, Graziella; Fatuzzo, Pasquale; Rapisarda, Francesco; Rastelli, Stefania; Fabrizi, Fabrizio; Messa, Piergiorgio; De Paola, Luciano; Lombardi, Luigi; Cupisti, Adamasco; Fuiano, Giorgio; Lucisano, Gaetano; Summaria, Chiara; Felisatti, Michele; Pozzato, Enrico; Malagoni, Anna Maria; Castellino, Pietro; Aucella, Filippo; Abd ElHafeez, Samar; Provenzano, Pasquale Fabio; Tripepi, Giovanni; Catizone, Luigi; Zoccali, Carmine

    2017-04-01

    Previous studies have suggested the benefits of physical exercise for patients on dialysis. We conducted the Exercise Introduction to Enhance Performance in Dialysis trial, a 6-month randomized, multicenter trial to test whether a simple, personalized walking exercise program at home, managed by dialysis staff, improves functional status in adult patients on dialysis. The main study outcomes included change in physical performance at 6 months, assessed by the 6-minute walking test and the five times sit-to-stand test, and in quality of life, assessed by the Kidney Disease Quality of Life Short Form (KDQOL-SF) questionnaire. We randomized 296 patients to normal physical activity (control; n=145) or walking exercise (n=151); 227 patients (exercise n=104; control n=123) repeated the 6-month evaluations. The distance covered during the 6-minute walking test improved in the exercise group (mean distance±SD: baseline, 328±96 m; 6 months, 367±113 m) but not in the control group (baseline, 321±107 m; 6 months, 324±116 m; Pquality of social interaction score (P=0.01) in the kidney disease component of the KDQOL-SF improved significantly in the exercise arm compared with the control arm. Hence, a simple, personalized, home-based, low-intensity exercise program managed by dialysis staff may improve physical performance and quality of life in patients on dialysis. Copyright © 2017 by the American Society of Nephrology.

  10. Using re-randomization to increase the recruitment rate in clinical trials ? an assessment of three clinical areas

    OpenAIRE

    Kahan, Brennan C.

    2016-01-01

    Background Patient recruitment in clinical trials is often challenging, and as a result, many trials are stopped early due to insufficient recruitment. The re-randomization design allows patients to be re-enrolled and re-randomized for each new treatment episode that they experience. Because it allows multiple enrollments for each patient, this design has been proposed as a way to increase the recruitment rate in clinical trials. However, it is unknown to what extent recruitment could be incr...

  11. Weight loss therapy for clinical management of patients with some atherosclerotic diseases: a randomized clinical trial.

    Science.gov (United States)

    Oshakbayev, Kuat; Dukenbayeva, Bibazhar; Otarbayev, Nurzhan; Togizbayeva, Gulnar; Tabynbayev, Nariman; Gazaliyeva, Meruyert; Idrisov, Alisher; Oshakbayev, Pernekul

    2015-11-25

    The prevalence and burden of atherosclerotic (AS) diseases are increasing during the last twenty years. Some studies show a close relationship between overweight and AS, but influence on AS diseases of different weight loss methods are still studying. The purpose of the research was to study the effectiveness of a weight loss program in AS patients in randomized controlled trial, and to develop a conception of evolution of AS. A randomized controlled prospective clinical trial including 97 people, from them 71 patients with various AS manifestations. Patients were divided in 2 subgroups for non-drug weight loss program, and conventional drug therapy. The weight loss program included calorie restriction with 100-150 kcal/day, fat-free vegetables, salt diet, and optimum physical activity. Statistical analysis was performed using SPSS for Windows version 17.0. The weight loss subgroup lost ranging between 7-20% from an initial weight (P = 0.016). Weight loss was achieved due to fatty mass reduction only (P = 0.005). Hemoglobin levels (P bone mineral density (P water (P = 0.006) and muscle masses (P = 0.0038) were increased in weight loss subgroup. Ejection fraction (P body fat. ClinicalTrials.gov NCT01700075. State registration is # 0109RK000079, code is O.0475 at the National Center for Scientific and Technical Information of the Republic of Kazakhstan.

  12. Cavity lining after excavating caries lesions: meta-analysis and trial sequential analysis of randomized clinical trials.

    Science.gov (United States)

    Schwendicke, Falk; Göstemeyer, Gerd; Gluud, Christian

    2015-11-01

    After removal of dentine caries lesions, cavity lining has been advocated. Non-clinical data support this approach, but clinical data are sparse and ambiguous. We aimed at evaluating the benefits and harms of cavity lining using meta-analysis and Trial Sequential Analysis. We included randomized clinical trials comparing restorations without versus with cavity lining for treating primary caries lesions. Only trials reporting failure (defined as need to re-retreat) after ≥1 year follow-up were included. Trial selection, data extraction, and risk of bias assessment were conducted independently by two reviewers. We conducted random-effects intention-to-treat and per-protocol meta-analyses, and Trial Sequential Analysis to control for random errors. Electronic databases (PubMed, Embase, CENTRAL) were systematically screened, and hand searches and cross-referencing performed. From 128 studies, three randomized trials (89/130 patients or teeth), all treating primary teeth, were included. The trials had high risk of bias. All trials compared no lining versus calcium hydroxide lining after selective caries removal followed by adhesive restoration. Follow-up was 36 to 53 months. Restoring the cavity without lining did not significantly affect the risk of failure (intention-to-treat relative risk (RR) (95% confidence interval) 0.71 (0.49-1.04), per-protocol RR 0.52 (0.24-1.10). According to Trial Sequential Analysis, no firm evidence was reached. The quality of evidence was very low. Strong recommendations for using cavity liners are unsubstantiated, but firm evidence for omitting lining is also unavailable. Our findings apply only to primary teeth and calcium hydroxide liner. Whilst lining is frequently performed in dental practice, very few randomized clinical trials investigated this issue. The three trials included in this review treated deciduous teeth and did not find lining with calcium hydroxide beneficial. Lining is not supported by sufficient clinical evidence

  13. Randomized controlled trials 5: Determining the sample size and power for clinical trials and cohort studies.

    Science.gov (United States)

    Greene, Tom

    2015-01-01

    Performing well-powered randomized controlled trials is of fundamental importance in clinical research. The goal of sample size calculations is to assure that statistical power is acceptable while maintaining a small probability of a type I error. This chapter overviews the fundamentals of sample size calculation for standard types of outcomes for two-group studies. It considers (1) the problems of determining the size of the treatment effect that the studies will be designed to detect, (2) the modifications to sample size calculations to account for loss to follow-up and nonadherence, (3) the options when initial calculations indicate that the feasible sample size is insufficient to provide adequate power, and (4) the implication of using multiple primary endpoints. Sample size estimates for longitudinal cohort studies must take account of confounding by baseline factors.

  14. Dietary Fiber Supplementation for Fecal Incontinence: A Randomized Clinical Trial

    Science.gov (United States)

    Bliss, Donna Z.; Savik, Kay; Jung, Hans-Joachim G.; Whitebird, Robin; Lowry, Ann; Sheng, Xioayan

    2014-01-01

    Dietary fiber supplements are used to manage fecal incontinence (FI), but little is known about the fiber type to recommend or the level of effectiveness of such supplements, which appear related to the fermentability of the fiber. The aim of this single-blind, randomized controlled trial was to compare the effects of three dietary fiber supplements (carboxymethylcellulose [CMC], gum arabic [GA], or psyllium) with differing levels of fermentability to a placebo in community-living individuals incontinent of loose/liquid feces. The primary outcome was FI frequency; secondary outcomes included FI amount and consistency, supplement intolerance, and quality of life (QoL). Possible mechanisms underlying supplement effects were also examined. After a 14-day baseline, 189 subjects consumed a placebo or 16g total fiber/day of one of the fiber supplements for 32 days. FI frequency significantly decreased after psyllium supplementation versus placebo, in both intent-to-treat and per-protocol mixed model analyses. CMC increased FI frequency. In intent-to-treat analysis, the number of FI episodes/week after supplementation was estimated to be 5.5 for Placebo, 2.5 for Psyllium, 4.3 for GA, and 6.2 for CMC. Only psyllium consumption resulted in a gel in feces. Supplement intolerance was low. QoL scores did not differ among groups. Patients with FI may experience a reduction in FI frequency after psyllium supplementation, and decreased FI frequency has been shown to be an important personal goal of treatment for patients with FI. Formation of a gel in feces appears to be a mechanism by which residual psyllium improved FI. PMID:25155992

  15. Dietary fiber supplementation for fecal incontinence: a randomized clinical trial.

    Science.gov (United States)

    Bliss, Donna Z; Savik, Kay; Jung, Hans-Joachim G; Whitebird, Robin; Lowry, Ann; Sheng, Xiaoyan

    2014-10-01

    Dietary fiber supplements are used to manage fecal incontinence (FI), but little is known about the fiber type to recommend or the level of effectiveness of such supplements, which appears related to the fermentability of the fiber. The aim of this single-blind, randomized controlled trial was to compare the effects of three dietary fiber supplements (carboxymethylcellulose [CMC], gum arabic [GA], or psyllium) with differing levels of fermentability to a placebo in community-living individuals incontinent of loose/liquid feces. The primary outcome was FI frequency; secondary outcomes included FI amount and consistency, supplement intolerance, and quality of life (QoL). Possible mechanisms underlying supplement effects were also examined. After a 14-day baseline, 189 subjects consumed a placebo or 16 g total fiber/day of one of the fiber supplements for 32 days. FI frequency significantly decreased after psyllium supplementation versus placebo, in both intent-to-treat and per-protocol mixed model analyses. CMC increased FI frequency. In intent-to-treat analysis, the number of FI episodes/week after supplementation was estimated to be 5.5 for Placebo, 2.5 for Psyllium, 4.3 for GA, and 6.2 for CMC. Only psyllium consumption resulted in a gel in feces. Supplement intolerance was low. QoL scores did not differ among groups. Patients with FI may experience a reduction in FI frequency after psyllium supplementation, and decreased FI frequency has been shown to be an important personal goal of treatment for patients with FI. Formation of a gel in feces appears to be a mechanism by which residual psyllium improved FI. © 2014 Wiley Periodicals, Inc.

  16. Clinical and radiographic comparison of primary molars after formocresol and electrosurgical pulpotomy: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Bahrololoomi Zahra

    2008-01-01

    Full Text Available Background: Vital pulpotomy is a single-stage procedure defined as the surgical amputation of the coronal portion of exposed vital pulp, usually as a means of preserving the vitality and function of the remaining radicular portion. Objectives : The aim of this study was to compare the clinical and radiographic success rates for electrosurgical vs formocresol pulpotomy in human primary molar teeth. Settings and Design: This was a prospective, randomized clinical trial. Materials and Methods: In this randomized clinical trial, pulpotomies were performed on 70 primary molars in children aged 5-10 years. The teeth were treated using either a conventional formocresol (35 teeth or electrosurgical technique (35 teeth. Following the pulpotomy procedure, the teeth were evaluated for clinical and radiographic success for three, six and nine months. The teeth were evaluated for the presence of pain, abscess, fistula, mobility, internal and external resorption, and radiolucency. Statistical Analysis : The data were assessed with Fishers′ Exact test. Results: After nine months of follow-up, the clinical and radiographic success rates were 96 and 84% respectively in the electrosurgical group and 100 and 96.8% respectively in the formocresol group. There was no statistically significant difference between the success rates in the two groups ( P > 0.05. Conclusions: Our results showed the failure rates for electrosurgical pulpotomy to be equal to those for formocresol pulpotomy. Although electrosurgical pulpotomy is a nonpharmacological technique giving favorable results, it is still a preservative technique. Further studies using larger samples and longer evaluation periods are recommended.

  17. Control of anxiety through music in a head and neckoutpatient clinic: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mariana Alves Firmeza

    Full Text Available Abstract OBJECTIVE Evaluating the effectiveness of a musical intervention in reducing anxiety and vital parameters in people suffering from head and neck cancer. METHOD A randomized controlled clinical trial, performed in a head and neck outpatient clinic with 40 participants, subdivided into two groups (intervention and control.The classicalmusic“Spring” from The Four Seasons by Vivaldi was used as an intervention.The State-Trait Anxiety Inventory (STAI was used as the data collectioninstrument,along with an inventory of socio-demographic and clinical data. Student'st-test was used to verify intragroup and intergroup statistical significance. RESULTS Participants presented a statistically significant reduction in levels of perceived anxiety (t= 12.68; p<0.001,as well as blood pressure levels (t = 4.56; p<0.001; pulse (t = 6.15; p<0.001 and respiratory rate (t = 5.10; p<0.001. CONCLUSION Music has proven to be an effective non-pharmacological therapeutic resource in managinganxiety in an outpatient setting for people with cancer, as well as in reducing blood pressure, pulse and respiratory rate. Brazilian Registry of Clinical Trials: RBR-7W4YJJ

  18. Using re-randomization to increase the recruitment rate in clinical trials - an assessment of three clinical areas.

    Science.gov (United States)

    Kahan, Brennan C

    2016-12-13

    Patient recruitment in clinical trials is often challenging, and as a result, many trials are stopped early due to insufficient recruitment. The re-randomization design allows patients to be re-enrolled and re-randomized for each new treatment episode that they experience. Because it allows multiple enrollments for each patient, this design has been proposed as a way to increase the recruitment rate in clinical trials. However, it is unknown to what extent recruitment could be increased in practice. We modelled the expected recruitment rate for parallel-group and re-randomization trials in different settings based on estimates from real trials and datasets. We considered three clinical areas: in vitro fertilization, severe asthma exacerbations, and acute sickle cell pain crises. We compared the two designs in terms of the expected time to complete recruitment, and the sample size recruited over a fixed recruitment period. Across the different scenarios we considered, we estimated that re-randomization could reduce the expected time to complete recruitment by between 4 and 22 months (relative reductions of 19% and 45%), or increase the sample size recruited over a fixed recruitment period by between 29% and 171%. Re-randomization can increase recruitment most for trials with a short follow-up period, a long trial recruitment duration, and patients with high rates of treatment episodes. Re-randomization has the potential to increase the recruitment rate in certain settings, and could lead to quicker and more efficient trials in these scenarios.

  19. Fool’s gold, lost treasures, and the randomized clinical trial

    Science.gov (United States)

    2013-01-01

    Background Randomized controlled trials with a survival endpoint are the gold standard for clinical research, but have failed to achieve cures for most advanced malignancies. The high costs of randomized clinical trials slow progress (thereby causing avoidable loss of life) and increase health care costs. Discussion A malignancy may be caused by several different mutations. Therapies effective vs one mutation may be discarded due to lack of statistical significance across the entire population. Conversely, expensive large randomized trials may have sufficient statistical power to demonstrate benefit despite the therapy only working in subgroups. Non-cost-effective therapy is then applied to all patients (including subgroups it cannot help). Randomized trials comparing therapies with different mechanisms of action are misleading since they may conclude the therapies are “equivalent” despite benefitting different subpopulations, or may erroneously conclude that one therapy is superior simply because it targets a larger subpopulation. Furthermore, minor variances in patient selection may determine study outcome, a therapy may be discarded as ineffective despite substantial benefit in one subpopulation if harmful in another, randomized trials may more effectively detect therapies with minor benefit in most patients vs marked benefit in subpopulations, and randomized trials in unselected patients may erroneously conclude that “shot-gun” combinations are superior to single agents when sequential administration of personalized single agents might work better and spare patients treatment with drugs that cannot help them. We must identify predictive biomarkers early by comparing responding to progressing patients in phase I-II trials. Enriching randomized trials for biomarker-positive patients can markedly reduce required patient numbers and costs despite expensive screening for biomarker-positive patients. Available data support approval of new drugs without

  20. OPPORTUNITY: a randomized clinical trial of growth hormone on outcome in hemodialysis patients

    DEFF Research Database (Denmark)

    Kopple, J.D.; Cheung, A.K.; Christiansen, J.S.

    2008-01-01

    , uncontrolled hypertension, chronic use of high-dose glucocorticoids, or immunosuppressive agents and pregnancy. CONCLUSIONS: The OPPORTUNITY Trial is the first large-scale randomized clinical trial in adult MHD patients evaluating the response to GH of such clinical endpoints as mortality, morbidity, markers...... human GH injections, compared with placebo, improve survival in hypoalbuminemic MHD patients. Secondary hypotheses are that GH improves morbidity and health, including number of hospitalized days, time to cardiovascular events, LBM, serum protein and inflammatory marker levels, exercise capacity...

  1. Bandit solutions provide unified ethical models for randomized clinical trials and comparative effectiveness research

    OpenAIRE

    Press, William H.

    2009-01-01

    As electronic medical records enable increasingly ambitious studies of treatment outcomes, ethical issues previously important only to limited clinical trials become relevant to unlimited whole populations. For randomized clinical trials, adaptive assignment strategies are known to expose substantially fewer patients to avoidable treatment failures than strategies with fixed assignments (e.g., equal sample sizes). An idealized adaptive case—the two-armed Bernoulli bandit problem—can be exactl...

  2. Acupuncture for Children with Autism Spectrum Disorders: A Systematic Review of Randomized Clinical Trials

    Science.gov (United States)

    Lee, Myeong Soo; Choi, Tae-Young; Shin, Byung-Cheul; Ernst, Edzard

    2012-01-01

    This study aimed to assess the effectiveness of acupuncture as a treatment for autism spectrum disorders (ASD). We searched the literature using 15 databases. Eleven randomized clinical trials (RCTs) met our inclusion criteria. Most had significant methodological weaknesses. The studies' statistical and clinical heterogeneity prevented us from…

  3. Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial.

    NARCIS (Netherlands)

    Hoeksma, H.L.; Dekker, J.; Ronday, H.K.; Heering, A.; Lubbe, N. van der; Vel, C.; Breedveld, F.C.; Ende, C.H.M. van den

    2004-01-01

    OBJECTIVE: To determine the effectiveness of a manual therapy program compared with an exercise therapy program in patients with osteoarthritis (OA) of the hip. METHODS: A single-blind, randomized clinical trial of 109 hip OA patients was carried out in the outpatient clinic for physical therapy of

  4. Randomized clinical trial of fibrin glue versus tacked fixation in laparoscopic groin hernia repair

    DEFF Research Database (Denmark)

    Tolver, Mette A; Rosenberg, Jacob; Juul, Poul

    2013-01-01

    BACKGROUND: Preliminary studies have indicated clinical advantages of mesh fixation using fibrin glue in transabdominal preperitoneal groin hernia repair (TAPP)  compared with tack fixation. The aim of this randomized double-blinded, controlled, clinical trial is to compare fibrin glue with tacks...

  5. The clinical efficacy of kinesio tape for shoulder pain: a randomized, double-blinded, clinical trial.

    Science.gov (United States)

    Thelen, Mark D; Dauber, James A; Stoneman, Paul D

    2008-07-01

    Prospective, randomized, double-blinded, clinical trial using a repeated-measures design. To determine the short-term clinical efficacy of Kinesio Tape (KT) when applied to college students with shoulder pain, as compared to a sham tape application. Tape is commonly used as an adjunct for treatment and prevention of musculoskeletal injuries. A majority of tape applications that are reported in the literature involve nonstretch tape. The KT method has gained significant popularity in recent years, but there is a paucity of evidence on its use. Forty-two subjects clinically diagnosed with rotator cuff tendonitis/impingement were randomly assigned to 1 of 2 groups: therapeutic KT group or sham KT group. Subjects wore the tape for 2 consecutive 3-day intervals. Self-reported pain and disability and pain-free active ranges of motion (ROM) were measured at multiple intervals to assess for differences between groups. The therapeutic KT group showed immediate improvement in pain-free shoulder abduction (mean +/- SD increase, 16.9 degrees +/- 23.2 degrees ; P = .005) after tape application. No other differences between groups regarding ROM, pain, or disability scores at any time interval were found. KT may be of some assistance to clinicians in improving pain-free active ROM immediately after tape application for patients with shoulder pain. Utilization of KT for decreasing pain intensity or disability for young patients with suspected shoulder tendonitis/impingement is not supported. Therapy, level 1b-.

  6. Clinical and microbiological effects of commercially available dentifrice containing amine fluoride: A randomized controlled clinical trial.

    Science.gov (United States)

    Pradeep, A R; Agarwal, Esha; Bajaj, Pavan; Naik, Savitha B; Kumari, Minal; Guruprasad, C N

    2012-07-01

    The inability of the normal adult population to perform adequate tooth brushing has led to the search for chemotherapeutic agents in order to improve plaque control. This 6 month, single center, randomized controlled clinical trial was conducted to assess the clinical and microbiological effects of a dentifrice containing only amine fluoride (AF) as the active ingredient on gingivitis. NINETY SUBJECTS DIAGNOSED WITH CHRONIC GENERALIZED GINGIVITIS WERE SELECTED AND RANDOMLY DIVIDED IN THREE GROUPS: Group 1 - placebo toothpaste, Group 2 - AF containing toothpaste, and Group 3 - triclosan containing toothpaste with polymer and fluoride. Clinical evaluation was undertaken using the gingival index of Loe and Silness and the plaque index and microbiological counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by a questionnaire. AF containing toothpaste showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to triclosan containing toothpaste. AF containing toothpaste may be a useful formulation for chemical plaque control agent and improvement in plaque and gingival status and add to the list of various therapeutic agents used for maintenance of gingival health.

  7. Clinical and microbiological effects of commercially available dentifrice containing amine fluoride: A randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    A R Pradeep

    2012-01-01

    Full Text Available Background: The inability of the normal adult population to perform adequate tooth brushing has led to the search for chemotherapeutic agents in order to improve plaque control. This 6 month, single center, randomized controlled clinical trial was conducted to assess the clinical and microbiological effects of a dentifrice containing only amine fluoride (AF as the active ingredient on gingivitis. Materials and Methods: Ninety subjects diagnosed with chronic generalized gingivitis were selected and randomly divided in three groups: Group 1 - placebo toothpaste, Group 2 - AF containing toothpaste, and Group 3 - triclosan containing toothpaste with polymer and fluoride. Clinical evaluation was undertaken using the gingival index of Loe and Silness and the plaque index and microbiological counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by a questionnaire. Results: AF containing toothpaste showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to triclosan containing toothpaste. Conclusions: AF containing toothpaste may be a useful formulation for chemical plaque control agent and improvement in plaque and gingival status and add to the list of various therapeutic agents used for maintenance of gingival health.

  8. Assessment of risk of bias in randomized clinical trials in surgery

    DEFF Research Database (Denmark)

    Gurusamy, K S; Gluud, C; Nikolova, D

    2009-01-01

    BACKGROUND: Meta-analysis of randomized clinical trials (RCTs) with low risk of bias is considered the highest level of evidence available for evaluating an intervention. Bias in RCTs may overestimate or underestimate the true effectiveness of an intervention. METHODS: The causes of bias...... in surgical trials as described by The Cochrane Collaboration, and the methods that can be used to avoid them, are reviewed. RESULTS: Blinding is difficult in many surgical trials but careful trial design can reduce the bias risk due to lack of blinding. It is possible to conduct surgical trials with low risk...... of bias by using appropriate trial design. CONCLUSION: The risk of providing a treatment based on a biased effect estimate must be balanced against the difficulty of conducting trials with very low risk of bias. Better understanding of the risk of bias may result in improved trials with a closer estimate...

  9. Effective Recruitment of Schools for Randomized Clinical Trials: Role of School Nurses.

    Science.gov (United States)

    Petosa, R L; Smith, L

    2017-01-01

    In school settings, nurses lead efforts to improve the student health and well-being to support academic success. Nurses are guided by evidenced-based practice and data to inform care decisions. The randomized controlled trial (RCT) is considered the gold standard of scientific rigor for clinical trials. RCTs are critical to the development of evidence-based health promotion programs in schools. The purpose of this article is to present practical solutions to implementing principles of randomization to RCT trials conducted in school settings. Randomization is a powerful sampling method used to build internal and external validity. The school's daily organization and educational mission provide several barriers to randomization. Based on the authors' experience in conducting school-based RCTs, they offer a host of practical solutions to working with schools to successfully implement randomization procedures. Nurses play a critical role in implementing RCTs in schools to promote rigorous science in support of evidence-based practice.

  10. Randomization in clinical trials: stratification or minimization? The HERMES free simulation software.

    Science.gov (United States)

    Fron Chabouis, Hélène; Chabouis, Francis; Gillaizeau, Florence; Durieux, Pierre; Chatellier, Gilles; Ruse, N Dorin; Attal, Jean-Pierre

    2014-01-01

    Operative clinical trials are often small and open-label. Randomization is therefore very important. Stratification and minimization are two randomization options in such trials. The first aim of this study was to compare stratification and minimization in terms of predictability and balance in order to help investigators choose the most appropriate allocation method. Our second aim was to evaluate the influence of various parameters on the performance of these techniques. The created software generated patients according to chosen trial parameters (e.g., number of important prognostic factors, number of operators or centers, etc.) and computed predictability and balance indicators for several stratification and minimization methods over a given number of simulations. Block size and proportion of random allocations could be chosen. A reference trial was chosen (50 patients, 1 prognostic factor, and 2 operators) and eight other trials derived from this reference trial were modeled. Predictability and balance indicators were calculated from 10,000 simulations per trial. Minimization performed better with complex trials (e.g., smaller sample size, increasing number of prognostic factors, and operators); stratification imbalance increased when the number of strata increased. An inverse correlation between imbalance and predictability was observed. A compromise between predictability and imbalance still has to be found by the investigator but our software (HERMES) gives concrete reasons for choosing between stratification and minimization; it can be downloaded free of charge. This software will help investigators choose the appropriate randomization method in future two-arm trials.

  11. Effect of creatine monohydrate on clinical progression in patients with Parkinson disease: a randomized clinical trial.

    Science.gov (United States)

    Kieburtz, Karl; Tilley, Barbara C; Elm, Jordan J; Babcock, Debra; Hauser, Robert; Ross, G Webster; Augustine, Alicia H; Augustine, Erika U; Aminoff, Michael J; Bodis-Wollner, Ivan G; Boyd, James; Cambi, Franca; Chou, Kelvin; Christine, Chadwick W; Cines, Michelle; Dahodwala, Nabila; Derwent, Lorelei; Dewey, Richard B; Hawthorne, Katherine; Houghton, David J; Kamp, Cornelia; Leehey, Maureen; Lew, Mark F; Liang, Grace S Lin; Luo, Sheng T; Mari, Zoltan; Morgan, John C; Parashos, Sotirios; Pérez, Adriana; Petrovitch, Helen; Rajan, Suja; Reichwein, Sue; Roth, Jessie Tatsuno; Schneider, Jay S; Shannon, Kathleen M; Simon, David K; Simuni, Tanya; Singer, Carlos; Sudarsky, Lewis; Tanner, Caroline M; Umeh, Chizoba C; Williams, Karen; Wills, Anne-Marie

    2015-02-10

    There are no treatments available to slow or prevent the progression of Parkinson disease, despite its global prevalence and significant health care burden. The National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson Disease program was established to promote discovery of potential therapies. To determine whether creatine monohydrate was more effective than placebo in slowing long-term clinical decline in participants with Parkinson disease. The Long-term Study 1, a multicenter, double-blind, parallel-group, placebo-controlled, 1:1 randomized efficacy trial. Participants were recruited from 45 investigative sites in the United States and Canada and included 1741 men and women with early (within 5 years of diagnosis) and treated (receiving dopaminergic therapy) Parkinson disease. Participants were enrolled from March 2007 to May 2010 and followed up until September 2013. Participants were randomized to placebo or creatine (10 g/d) monohydrate for a minimum of 5 years (maximum follow-up, 8 years). The primary outcome measure was a difference in clinical decline from baseline to 5-year follow-up, compared between the 2 treatment groups using a global statistical test. Clinical status was defined by 5 outcome measures: Modified Rankin Scale, Symbol Digit Modalities Test, PDQ-39 Summary Index, Schwab and England Activities of Daily Living scale, and ambulatory capacity. All outcomes were coded such that higher scores indicated worse outcomes and were analyzed by a global statistical test. Higher summed ranks (range, 5-4775) indicate worse outcomes. The trial was terminated early for futility based on results of a planned interim analysis of participants enrolled at least 5 years prior to the date of the analysis (n = 955). The median follow-up time was 4 years. Of the 955 participants, the mean of the summed ranks for placebo was 2360 (95% CI, 2249-2470) and for creatine was 2414 (95% CI, 2304-2524). The global statistical test

  12. Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial. A registry-based randomized clinical trial

    DEFF Research Database (Denmark)

    Fröbert, Ole; Götberg, Matthias; Angerås, Oskar

    2017-01-01

    BACKGROUND: Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following...... influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI. METHODS/DESIGN: The Influenza...... vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly...

  13. Sweet Sixteen: The Prospective Clinical Trials of John L. Cameron, MD-The Clinician-Scientist: From Alternate-Allocation to Randomized Controlled Trials.

    Science.gov (United States)

    Yeo, Charles J

    2017-09-15

    : The era of randomized controlled trials was ushered in by the British epidemiologist-statistician Austin Bradford Hill, with his work on the use of streptomycin in patients with tuberculosis. John L. Cameron, can be linked to 16 prospective clinical trials over his career thus far, starting with alternate-allocation trials and transitioning to prospective, randomized, placebo-controlled trials. These trials studied various topics in surgery-from pancreatitis to surgical site infections, to drain trials, a trial in Crohn disease and multiple trials in pancreatic surgery and cancer. Herein are described the "sweet sixteen" prospective clinical trials of Dr Cameron.

  14. Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

    OpenAIRE

    amrutesh, sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

    2010-01-01

    Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hyg...

  15. The Use of Wet Cupping for Persistent Nonspecific Low Back Pain: Randomized Controlled Clinical Trial

    OpenAIRE

    AlBedah,Abdullah; Khalil, Mohamed; ElOlemy, Ahmed; Asim A. Hussein; Alqaed,Meshari; Al Mudaiheem, Abdullah; Abutalib, Raid A.; Bazaid, Faisal Mohamed; Bafail, Ahmad Saeed; Essa, AboBakr; Bakrain, Mohammed Yahia

    2015-01-01

    Abstract Objectives: To evaluate the effectiveness and safety of wet cupping therapy as a single treatment for persistent nonspecific low back pain (PNSLBP). Design: Randomized controlled trial comparing wet cupping versus no treatment in PNSLBP. Setting: Outpatient clinic in three secondary care hospitals in Saudi Arabia. Patients: Eighty eligible participants with PNSLBP for at least 3 months were randomly allocated to an intervention group (n=40) or to a control group (n=40). Interventions...

  16. Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

    Science.gov (United States)

    McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

    2008-01-01

    No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

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

    Science.gov (United States)

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

    2012-01-01

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

  18. A Randomized Clinical Trial of Alternative Stress Management Interventions in Persons with HIV Infection

    Science.gov (United States)

    McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney

    2008-01-01

    Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…

  19. Cyanoacrylate Skin Microsealant for Preventing Surgical Site Infection after Vascular Surgery : A Discontinued Randomized Clinical Trial

    NARCIS (Netherlands)

    Vierhout, Bastiaan P.; Ott, Alewijn; Reijnen, Michel M. P. J.; Oskam, Jacques; Ott, Alewijn; van den Dungen, Jan J. A. M.; Zeebregts, Clark J.

    Background: Surgical site infections (SSI) after vascular surgery are related to substantial morbidity. Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept. We performed a randomized clinical trial to assess the effect of the sealing of skin with a

  20. Efficacy and safety of femtosecond laser-assisted corneal endothelial keratoplasty: a randomized multicenter clinical trial.

    NARCIS (Netherlands)

    Cheng, Y.Y.; Schouten, J.S.A.G.; Tahzib, N.G.; Wijdh, R.J.; Pels, E.; Cleynenbreugel, H. van; Eggink, C.A.; Rijneveld, W.J.; Nuijts, R.M.

    2009-01-01

    BACKGROUND: To evaluate the efficacy and safety of femtosecond laser-assisted endothelial keratoplasty (FLEK) versus penetrating keratoplasty (PK) in patients with corneal endothelial disease. METHODS: A randomized multicenter clinical trial of 80 eyes of 80 patients with corneal endothelial disease

  1. Efficacy and Safety of Femtosecond Laser-Assisted Corneal Endothelial Keratoplasty : A Randomized Multicenter Clinical Trial

    NARCIS (Netherlands)

    Cheng, Yanny Y. Y.; Schouten, Jan S. A. G.; Tahzib, Nayyirih G.; Wijdh, Robert-Jan; Pels, Elisabeth; van Cleynenbreugel, Hugo; Eggink, Catharina A.; Rijneveld, Wilhelmina J.; Nuijts, Rudy M. M. A.

    2009-01-01

    Background. To evaluate the efficacy and safety of femtosecond laser-assisted endothelial keratoplasty (FLEK) versus penetrating keratoplasty (PK) in patients with corneal endothelial disease. Methods. A randomized multicenter clinical trial of 80 eyes of 80 patients with corneal endothelial disease

  2. Mindfulness-Based Stress Reduction for the Treatment of Adolescent Psychiatric Outpatients: A Randomized Clinical Trial

    Science.gov (United States)

    Biegel, Gina M.; Brown, Kirk Warren; Shapiro, Shauna L.; Schubert, Christine M.

    2009-01-01

    Research has shown that mindfulness-based treatment interventions may be effective for a range of mental and physical health disorders in adult populations, but little is known about the effectiveness of such interventions for treating adolescent conditions. The present randomized clinical trial was designed to assess the effect of the…

  3. Moving from Efficacy to Effectiveness in Cognitive Behavioral Therapy for Psychosis: A Randomized Clinical Practice Trial

    Science.gov (United States)

    Lincoln, Tania M.; Ziegler, Michael; Mehl, Stephanie; Kesting, Marie-Luise; Lullmann, Eva; Westermann, Stefan; Rief, Winfried

    2012-01-01

    Objective: Randomized controlled trials have attested the efficacy of cognitive behavioral therapy (CBT) in reducing psychotic symptoms. Now, studies are needed to investigate its effectiveness in routine clinical practice settings. Method: Eighty patients with schizophrenia spectrum disorders who were seeking outpatient treatment were randomized…

  4. Fundamentals of randomized clinical trials in wound care: Design and conduct

    NARCIS (Netherlands)

    Eskes, Anne M.; Brölmann, Fleur E.; Sumpio, Bauer E.; Mayer, Dieter; Moore, Zena; Agren, Magnus S.; Hermans, Michel; Cutting, Keith; Legemate, Dink A.; Ubbink, Dirk T.; Vermeulen, Hester

    2012-01-01

    The care for chronic and acute wounds is a substantial problem around the world. This has led to a plethora of products to accelerate healing. Unfortunately, the quality of studies evaluating the efficacy of such wound care products is frequently low. Randomized clinical trials are universally

  5. Crown vs. composite for post-retained restorations: A randomized clinical trial

    NARCIS (Netherlands)

    Skupien, J.A.; Cenci, M.S.; Opdam, N.J.; Kreulen, C.M.; Huysmans, M.C.; Pereira-Cenci, T.

    2016-01-01

    OBJECTIVES: This randomized clinical trial compared the survival of composite resin restorations and metal-ceramic crowns on endodontically treated teeth that received a glass fiber post using 2 different cementation methods. METHODS: Forty-seven patients (age 42.5+/-11.5) with fifty-seven

  6. RANDOMIZED CONTROLLED TRIALS OF MATERNAL-FETAL SURGERY : A CHALLENGE TO CLINICAL EQUIPOISE

    NARCIS (Netherlands)

    Rodrigues, H. C. M. L.; van den Berg, P. P.

    2014-01-01

    This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception

  7. A randomized clinical trial on the sealing of occlusal carious lesions

    DEFF Research Database (Denmark)

    Alves, Luana Severo; Giongo, Fernanda Cristina Mendes de Santa; Mua, Bruna

    2017-01-01

    This randomized clinical trial aimed to assess the efficacy of sealing occlusal carious lesions in permanent teeth. The sample consisted of 54 occlusal carious lesions in permanent molars and premolars of 49 patients aged 8-43 years (median: 19 years). The inclusion criteria comprised the presenc...

  8. Randomized Clinical Trial: The Use of SpeechEasy® in Stuttering Treatment

    Science.gov (United States)

    Ritto, Ana Paula; Juste, Fabiola Staróbole; Stuart, Andrew; Kalinowski, Joseph; de Andrade, Claudia Regina Furquim

    2016-01-01

    Background: Numerous studies have demonstrated the benefit of devices delivering altered auditory feedback (AAF) as a therapeutic alternative for those who stutter. Aims: The effectiveness of a device delivering AAF (SpeechEasy®) was compared with behavioural techniques in the treatment of stuttering in a randomized clinical trial. Methods &…

  9. Low vision depression prevention trial in age-related macular degeneration: a randomized clinical trial.

    Science.gov (United States)

    Rovner, Barry W; Casten, Robin J; Hegel, Mark T; Massof, Robert W; Leiby, Benjamin E; Ho, Allen C; Tasman, William S

    2014-11-01

    To compare the efficacy of behavior activation (BA) + low vision rehabilitation (LVR) with supportive therapy (ST) + LVR to prevent depressive disorders in patients with age-related macular degeneration (AMD). Single-masked, attention-controlled, randomized, clinical trial with outcome assessment at 4 months. Patients with AMD and subsyndromal depressive symptoms attending retina practices (n = 188). Before randomization, all subjects had 2 outpatient LVR visits, and were then randomized to in-home BA+LVR or ST+LVR. Behavior activation is a structured behavioral treatment that aims to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention. The Diagnostic and Statistical Manual IV defined depressive disorder based on the Patient Health Questionnaire-9 (primary outcome), Activities Inventory, National Eye Institute Vision Function Questionnaire-25 plus Supplement (NEI-VFQ), and NEI-VFQ quality of life (secondary outcomes). At 4 months, 11 BA+LVR subjects (12.6%) and 18 ST+LVR subjects (23.4%) developed a depressive disorder (relative risk [RR], 0.54; 95% CI, 0.27-1.06; P = 0.067). In planned adjusted analyses the RR was 0.51 (95% CI, 0.27-0.98; P = 0.04). A mediational analysis suggested that BA+LVR prevented depression to the extent that it enabled subjects to remain socially engaged. In addition, BA+LVR was associated with greater improvements in functional vision than ST+LVR, although there was no significant between-group difference. There was no significant change or between-group difference in quality of life. An integrated mental health and low vision intervention halved the incidence of depressive disorders relative to standard outpatient LVR in patients with AMD. As the population ages, the number of persons with AMD and the adverse effects of comorbid depression will increase. Promoting interactions between ophthalmology, optometry

  10. Therapeutic alliance in a randomized clinical trial for bulimia nervosa.

    Science.gov (United States)

    Accurso, Erin C; Fitzsimmons-Craft, Ellen E; Ciao, Anna; Cao, Li; Crosby, Ross D; Smith, Tracey L; Klein, Marjorie H; Mitchell, James E; Crow, Scott J; Wonderlich, Stephen A; Peterson, Carol B

    2015-06-01

    This study examined the temporal relation between therapeutic alliance and outcome in two treatments for bulimia nervosa (BN). Eighty adults with BN symptoms were randomized to 21 sessions of integrative cognitive-affective therapy (ICAT) or enhanced cognitive-behavioral therapy (CBT-E). Bulimic symptoms (i.e., frequency of binge eating and purging) were assessed at each session and posttreatment. Therapeutic alliance (Working Alliance Inventory) was assessed at Sessions 2, 8, 14, and posttreatment. Repeated-measures analyses using linear mixed models with random intercepts were conducted to determine differences in alliance growth by treatment and patient characteristics. Mixed-effects models examined the relation between alliance and symptom improvement. Overall, patients in both treatments reported strong therapeutic alliances. Regardless of treatment, greater therapeutic alliance between (but not within) subjects predicted greater reductions in bulimic behavior; reductions in bulimic behavior also predicted improved alliance. Patients with higher depression, anxiety, or emotion dysregulation had a stronger therapeutic alliance in CBT-E than ICAT, while those with more intimacy problems had greater improvement in therapeutic alliance in ICAT compared to CBT-E. Therapeutic alliance has a unique impact on outcome, independent of the impact of symptom improvement on alliance. Within- and between-subjects effects revealed that changes in alliance over time did not predict symptom improvement, but rather that individuals who had a stronger alliance overall had better bulimic symptom outcomes. These findings indicate that therapeutic alliance is an important predictor of outcome in the treatment of BN. (c) 2015 APA, all rights reserved).

  11. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

    Energy Technology Data Exchange (ETDEWEB)

    Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lee, J. Jack [Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Heymach, John V. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Swisher, Stephen G. [Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Welsh, James W. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Zhang, Jianjun [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lin, Steven H. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Gomez, Daniel R., E-mail: dgomez@mdanderson.org [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)

    2017-03-15

    Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

  12. Anesthetic Efficacy in Irreversible Pulpitis: A Randomized Clinical Trial.

    Science.gov (United States)

    Allegretti, Carlos E; Sampaio, Roberta M; Horliana, Anna C R T; Armonia, Paschoal L; Rocha, Rodney G; Tortamano, Isabel Peixoto

    2016-01-01

    Inferior alveolar nerve block has a high failure rate in the treatment of mandibular posterior teeth with irreversible pulpitis. The aim of this study was to compare the anesthetic efficacy of 4% articaine, 2% lidocaine and 2% mepivacaine, all in combination with 1:100,000 epinephrine, in patients with irreversible pulpitis of permanent mandibular molars during a pulpectomy procedure. Sixty-six volunteers from the Emergency Center of the School of Dentistry, University of São Paulo, randomly received 3.6 mL of local anesthetic as a conventional inferior alveolar nerve block (IANB). The subjective signal of lip numbness, pulpal anesthesia and absence of pain during the pulpectomy procedure were evaluated respectively, by questioning the patient, stimulation using an electric pulp tester and a verbal analogue scale. All patients reported the subjective signal of lip numbness. Regarding pulpal anesthesia success as measured with the pulp tester, the success rate was respectively 68.2% for mepivacaine, 63.6% for articaine and 63.6% for lidocaine. Regarding patients who reported no pain or mild pain during the pulpectomy, the success rate was, respectively 72.7% for mepivacaine, 63.6% for articaine and 54.5% for lidocaine. These differences were not statistically significant. Neither of the solutions resulted in 100% anesthetic success in patients with irreversible pulpitis of mandibular molars.

  13. Audio-recorded information to patients considering participation in cancer clinical trials - a randomized study.

    Science.gov (United States)

    Bergenmar, Mia; Johansson, Hemming; Wilking, Nils; Hatschek, Thomas; Brandberg, Yvonne

    2014-09-01

    Patient information in cancer clinical trial is challenging. The value of audio-recording interventions for patients considering participating in clinical trials is unclear. The primary aim of this randomized study was to investigate effects of audio-recorded information on knowledge and understanding in patients considering participation in a clinical trial. Patients scheduled for information about a phases 2 or 3 trial by one of the 13 participating oncologists at the Department of Oncology during the study period (2008-2013) were eligible. The intervention consisted of an audio-recording on compact disc (CD) of the information at the medical consultation in which the patients were informed about a trial. Knowledge and understanding was measured by the questionnaire, Quality of Informed Consent. A total of 130 patients were randomized, 70% of the calculated sample size (n = 186). Sixty-seven patients were randomized to the intervention. In total, 101 patients (78%) completed questionnaires. No statistical significant differences were found between the groups with respect to knowledge and understanding. The level of knowledge was relatively high, with the exceptions of the risks associated with, and the unproven nature of, the trial. Overall, patients who declined participation scored statistically significant lower on knowledge. The present study was underpowered and the results should therefore be interpreted with caution. Still, 130 patients were included with a response rate of 78%. A CD including the oral information about a clinical trial did not show any effects on knowledge or understanding. However, the levels of knowledge were high, possible due to the high levels of education in the study group. Information on risks associated with the trial is still an area for improvement.

  14. Comparative Effectiveness of Clinical-Community Childhood Obesity Interventions: A Randomized Clinical Trial.

    Science.gov (United States)

    Taveras, Elsie M; Marshall, Richard; Sharifi, Mona; Avalon, Earlene; Fiechtner, Lauren; Horan, Christine; Gerber, Monica W; Orav, E John; Price, Sarah N; Sequist, Thomas; Slater, Daniel

    2017-08-07

    Novel approaches to care delivery that leverage clinical and community resources could improve body mass index (BMI) and family-centered outcomes. To examine the extent to which 2 clinical-community interventions improved child BMI z score and health-related quality of life, as well as parental resource empowerment in the Connect for Health Trial. This 2-arm, blinded, randomized clinical trial was conducted from June 2014 through March 2016, with measures at baseline and 1 year after randomization. This intent-to-treat analysis included 721 children ages 2 to 12 years with BMI in the 85th or greater percentile from 6 primary care practices in Massachusetts. Children were randomized to 1 of 2 arms: (1) enhanced primary care (eg, flagging of children with BMI ≥ 85th percentile, clinical decision support tools for pediatric weight management, parent educational materials, a Neighborhood Resource Guide, and monthly text messages) or (2) enhanced primary care plus contextually tailored, individual health coaching (twice-weekly text messages and telephone or video contacts every other month) to support behavior change and linkage of families to neighborhood resources. One-year changes in age- and sex-specific BMI z score, child health-related quality of life measured by the Pediatric Quality of Life 4.0, and parental resource empowerment. At 1 year, we obtained BMI z scores from 664 children (92%) and family-centered outcomes from 657 parents (91%). The baseline mean (SD) age was 8.0 (3.0) years; 35% were white (n = 252), 33.3% were black (n = 240), 21.8% were Hispanic (n = 157), and 9.9% were of another race/ethnicity (n = 71). In the enhanced primary care group, adjusted mean (SD) BMI z score was 1.91 (0.56) at baseline and 1.85 (0.58) at 1 year, an improvement of -0.06 BMI z score units (95% CI, -0.10 to -0.02) from baseline to 1 year. In the enhanced primary care plus coaching group, the adjusted mean (SD) BMI z score was 1.87 (0.56) at baseline

  15. Randomized clinical trial of nutritional counseling for malnourished hospital patients.

    Science.gov (United States)

    Casals, C; García-Agua-Soler, N; Vázquez-Sánchez, M Á; Requena-Toro, M V; Padilla-Romero, L; Casals-Sánchez, J L

    2015-01-01

    Malnutrition is associated with an increased risk of mortality and morbidity, longer hospital stays and general loss of quality of life. The aim of this study is to assess the impact of dietary counseling for malnourished hospital patients. Prospective, randomized, open-label study of 106 hospital patients with malnutrition (54 in the control group and 52 in the intervention group). The intervention group received dietary counseling, and the control group underwent standard treatment. We determined the patients' nutritional state (body mass index, laboratory parameters, malnutrition universal screening tool), degree of dependence (Barthel index), quality of life (SF-12), degree of satisfaction (CSQ-8), the number and length of readmissions and mortality. The patients who underwent the "intervention" increased their weight at 6 months, while the controls lost weight (difference in body mass index, 2.14kg/m(2); p<.001). The intervention group had better results when compared with the control group in the Malnutrition Universal Screening Tool scores (difference, -1.29; p<.001), Barthel index (difference, 7.49; p=.025), SF-12 (difference, 13.72; p<.001) and CSQ-8 (difference, 4.34, p<.001) and required fewer readmissions (difference, -0.37; p=.04) and shorter stays for readmissions (difference, -6.75; p=.035). Mortality and laboratory parameters were similar for the 2 groups. Nutritional counseling improved the patients' nutritional state, quality of life and degree of dependence and decreased the number of hospital readmissions. Copyright © 2015 Elsevier España, S.L.U. y Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  16. Experimental gingivitis, bacteremia and systemic biomarkers: a randomized clinical trial.

    Science.gov (United States)

    Kinane, D F; Zhang, P; Benakanakere, M; Singleton, J; Biesbrock, A; Nonnenmacher, C; He, T

    2015-12-01

    Bacteremia and systemic inflammatory markers are associated with periodontal and systemic diseases and may be linking mechanisms between these conditions. We hypothesized that in the development of gingival inflammation, systemic markers of inflammation and bacteremia would increase. To study the effect of bacteremia on systemic inflammatory markers, we recruited 80 subjects to participate in an experimental gingivitis study. Subjects were stratified based on gender, smoking and the number of bleeding sites and then randomized to one of two groups: control group (n = 40) or experimental gingivitis group (n = 40). Subjects in the control group conducted an oral hygiene regimen: brushing twice daily with a regular sodium fluoride cavity protection dentifrice and a standard manual toothbrush, flossing twice daily, and mouth rinsing with an anti-cavity fluoride rinse once daily. The experimental group stopped brushing and flossing, and used only the fluoride anti-cavity mouth rinse for 21 d. Seventy-nine of 80 subjects were evaluable. One subject in the control group was excluded from the results due to antibiotic use during the study. Our data showed the experimental gingivitis group exhibited a significant (p gingival inflammatory indices relative to baseline and the control group but a decrease in bacteremia and soluble intercellular adhesion molecule-1 levels vs. baseline. Bacteremia was negatively correlated with gingival inflammatory indices and soluble intercellular adhesion molecule-1 levels in the experimental gingivitis group, thus negating our hypothesis. We conclude that there are marked differences in systemic cytokine levels over the course of short-term experimentally induced gingivitis and further conclude that a long-term periodontitis study must be considered to address mechanisms whereby oral diseases may affect systemic diseases. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  17. Preoperative lifestyle intervention in bariatric surgery: a randomized clinical trial.

    Science.gov (United States)

    Kalarchian, Melissa A; Marcus, Marsha D; Courcoulas, Anita P; Cheng, Yu; Levine, Michele D

    2016-01-01

    Studies on the impact of presurgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. To evaluate whether a presurgery behavioral lifestyle intervention improves weight loss through a 24-month postsurgery period. Bariatric Center of Excellence at a large, urban medical center. Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual presurgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions, followed by 16 weeks of face-to-face and telephone sessions before surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted 6, 12, and 24 months after surgery. Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average body mass index was 47.5 kg/m(2) at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12-, and 24-month assessments, respectively. Percent weight loss from study enrollment to 6 and 12 months after surgery was comparable for both groups, but at 24 months after surgery, the lifestyle group had significantly smaller percent weight loss compared with the usual care group (26.5% versus 29.5%, respectively, P = .02). Presurgery lifestyle intervention did not improve weight loss at 24 months after surgery. The findings from this study raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  18. Preoperative Lifestyle Intervention in Bariatric Surgery: A Randomized Clinical Trial

    Science.gov (United States)

    Kalarchian, Melissa A.; Marcus, Marsha D.; Courcoulas, Anita P.; Cheng, Yu; Levine, Michele D.

    2015-01-01

    Background Studies of the impact of pre-surgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed. Objective To evaluate whether a pre-surgery behavioral lifestyle intervention improves weight loss through 24-months post-surgery. Setting Bariatric Center of Excellence at a large, urban medical center. Methods Candidates for bariatric surgery were randomized to a 6-month behavioral lifestyle intervention or to 6 months of usual pre-surgical care. The lifestyle intervention consisted of 8 weekly face-to-face sessions followed by 16 weeks of face-to-face and telephone sessions prior to surgery; the intervention also included 3 monthly telephone contacts after surgery. Assessments were conducted at 6-, 12- and 24-months post-surgery. Results Participants who underwent surgery (n = 143) were 90.2% female and 86.7% White. Average age was 44.9 years, and average BMI was 47.5 kg/m2 at study enrollment. At follow-up, 131 (91.6%), 126 (88.1%), 117 (81.8%) patients participated in the 6-, 12- and 24 month assessments, respectively. Percent weight loss from study enrollment to 6- and 12-months post-surgery was comparable for both groups, but at 24-months post-surgery, the lifestyle group had significantly smaller percent weight loss than the usual care group (26.5% vs. 29.5%, respectively, p = 0.02). Conclusions Pre-surgery lifestyle intervention did not improve weight loss at 24 months post-surgery. Findings raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients. PMID:26410538

  19. Chinese herbal medicine for cancer-related fatigue: a systematic review of randomized clinical trials.

    Science.gov (United States)

    Su, Chun-Xiang; Wang, Li-Qiong; Grant, Suzanne J; Liu, Jian-Ping

    2014-06-01

    To assess the effectiveness and safety of Chinese herbal medicine for the treatment of cancer-related fatigue. We systematically searched seven electronic databases and two trial registries for randomized clinical trials of Chinese herbal medicine for cancer-related fatigue. Two authors independently extracted data and assessed the methodological quality of the included trials using the Cochrane risk of bias tool. Data were synthesized using RevMan 5.2 software. A total of 10 trials involving 751 participants with cancer-related fatigue were identified and the methodological quality of the included trials was generally poor. Chinese herbal medicine used alone or in combination with chemotherapy or supportive care showed significant relief in cancer-related fatigue compared to placebo, chemotherapy or supportive care based on single trials. Chinese herbal medicine plus chemotherapy or supportive care was superior to chemotherapy or supportive care in improving quality of life. Data from one trial demonstrated Chinese herbal medicine exerted a greater beneficial effect on relieving anxiety but no difference in alleviating depression. Seven trials reported adverse events and no severe adverse effects were found in Chinese herbal medicine groups. The findings from limited number of trials suggest that Chinese herbal medicine seems to be effective and safe in the treatment of cancer-related fatigue. However, the current evidence is insufficient to draw a confirmative conclusion due to the poor methodological quality of included trials. Thus, conducting rigorously designed trials on potential Chinese herbal medicine is warranted. Copyright © 2014 Elsevier Ltd. All rights reserved.

  20. Observer bias in randomized clinical trials with time-to-event outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2014-01-01

    intravenous administration of the same drug, resulting in bias favouring the control intervention, RHR 1.33 (0.98 to 1.82). Seven trials of cytomegalovirus retinitis, tibial fracture and multiple sclerosis compared experimental interventions with standard control interventions, e.g. placebo, no-treatment......BACKGROUND: We wanted to evaluate the impact of nonblinded outcome assessors on estimated treatment effects in time-to-event trials. METHODS: Systematic review of randomized clinical trials with both blinded and nonblinded assessors of the same time-to-event outcome. Two authors agreed on inclusion...... or active control, resulting in bias favouring the experimental intervention, RHR 0.73 (0.57 to 0.93), indicating an average exaggeration of nonblinded hazard ratios by 27% (7% to 43%). CONCLUSIONS: Lack of blinded outcome assessors in randomized trials with subjective time-to-event outcomes causes high...

  1. Midpalatal implants vs headgear for orthodontic anchorage - a randomized clinical trial: Cephalometric results\\ud

    OpenAIRE

    Benson, P.E.; Tinsley, D.; O'Dwyer, J.J; Majumdar, A.; Doyle, P.; Sandler, P.J.

    2007-01-01

    OBJECTIVE: To compare the clinical effectiveness of the mid-palatal implant as a method of reinforcing anchorage during orthodontic treatment with that of conventional extra-oral anchorage.\\ud \\ud DESIGN: A prospective, randomized, clinical trial\\ud Setting: Chesterfield and North Derbyshire Royal Hospital NHS Trust and the Charles Clifford Dental Hospital, Sheffield.\\ud \\ud SUBJECTS AND METHODS: 51 orthodontic patients between the ages of 12 and 39, with a class II division 1 malocclusion an...

  2. Two-year Randomized Clinical Trial Of Self-etching Adhesives And Selective Enamel Etching

    OpenAIRE

    Pena, MR; Rodrigues CE; JA; Ely; Giannini, C.; Reis, M; AF

    2016-01-01

    Objective: The aim of this randomized, controlled prospective clinical trial was to evaluate the clinical effectiveness of restoring noncarious cervical lesions with two self-etching adhesive systems applied with or without selective enamel etching. Methods: A one-step self-etching adhesive (Xeno V+) and a two-step self-etching system (Clearfil SE Bond) were used. The effectiveness of phosphoric acid selective etching of enamel margins was also evaluated. Fifty-six cavities were restored with...

  3. Saffron (Crocus sativus L.) and major depressive disorder: a meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Hausenblas, Heather Ann; Saha, Debbie; Dubyak, Pamela Jean; Anton, Stephen Douglas

    2013-11-01

    Due to safety concerns and side effects of many antidepressant medications, herbal psychopharmacology research has increased, and herbal remedies are becoming increasingly popular as alternatives to prescribed medications for the treatment of major depressive disorder (MDD). Of these, accumulating trials reveal positive effects of the spice saffron (Crocus sativus L.) for the treatment of depression. A comprehensive and statistical review of the clinical trials examining the effects of saffron for treatment of MDD is warranted. The purpose of this study was to conduct a meta-analysis of published randomized controlled trials examining the effects of saffron supplementation on symptoms of depression among participants with MDD. We conducted electronic and non-electronic searches to identify all relevant randomized, double-blind controlled trials. Reference lists of all retrieved articles were searched for relevant studies. The criteria for study selection included the following: (1) adults (aged 18 and older) with symptoms of depression, (2) randomized controlled trial, (3) effects of saffron supplementation on depressive symptoms examined, and (4) study had either a placebo control or antidepressant comparison group. Using random effects modeling procedures, we calculated weighted mean effect sizes separately for the saffron supplementation vs placebo control groups, and for the saffron supplementation vs antidepressant groups. The methodological quality of all studies was assessed using the Jadad score. The computer software Comprehensive Meta-analysis 2 was used to analyze the data. Based on our pre-specified criteria, five randomized controlled trials (n = 2 placebo controlled trials, n = 3 antidepressant controlled trials) were included in our review. A large effect size was found for saffron supplementation vs placebo control in treating depressive symptoms (M ES = 1.62, P saffron supplementation significantly reduced depression symptoms compared to the

  4. Clinical Trials

    Medline Plus

    Full Text Available ... they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner ... the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing ...

  5. Clinical Trials

    Science.gov (United States)

    Clinical trials are research studies that test how well new medical approaches work in people. Each study answers ... prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a ...

  6. Clinical Trials

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    Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... are research studies that explore whether a medical strategy, treatment, or device is safe and effective for ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

  9. Clinical Trials

    Medline Plus

    Full Text Available ... treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ... are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and ...

  10. Clinical Trials

    Medline Plus

    Full Text Available ... and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

  11. Clinical Trials

    Medline Plus

    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ... lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

  12. Clinical Trials

    Medline Plus

    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... care providers might be part of your treatment team. They will monitor your health closely. You may ...

  13. Randomized clinical trial comparing an oral carbohydrate beverage with placebo before laparoscopic cholecystectomy

    DEFF Research Database (Denmark)

    Bisgaard, T; Kristiansen, V B; Hjortsø, N C

    2004-01-01

    evaluated the clinical effects of a preoperative carbohydrate beverage in patients undergoing laparoscopic cholecystectomy. METHODS: Ninety-four patients undergoing laparoscopic cholecystectomy were included in a randomized clinical trial. Patients were randomized to receive 800 ml of an iso-osmolar 12.......5 per cent carbohydrate-rich beverage the evening before operation (100 g carbohydrate) and another 400 ml (50 g carbohydrate) 2 h before initiation of anaesthesia, or the same volume of a placebo beverage. The primary endpoint was general well-being the day after operation. Patients were evaluated from...

  14. Local Minocycline Effect on Inflammation and Clinical Attachment During Periodontal Maintenance: Randomized Clinical Trial.

    Science.gov (United States)

    Killeen, Amy C; Harn, Jennifer A; Erickson, Leah M; Yu, Fang; Reinhardt, Richard A

    2016-10-01

    Minocycline microspheres (MMs) are being used to treat residual inflamed periodontal pockets during periodontal maintenance therapy (PMT), but evidence for efficacy from randomized clinical trials is lacking. The purpose of this study is to evaluate the effect of MMs plus scaling and root planing (SRP) on these sites. Sixty patients with chronic periodontitis on 6-month PMT intervals to be followed for 1 year were randomized (51 completed the study) into two statistically similar groups, SRP + MM (aged 66.8 years) and SRP alone (aged 67 years), to treat a ≥5 mm posterior interproximal pocket during PMT with a history of bleeding on probing (BOP). Group treatments were applied to the site at baseline and 6 months. Clinical attachment levels (CALs; primary outcome), probing depths (PDs), plaque, and BOP also were recorded at baseline and 6 and 12 months. In addition, gingival crevicular fluid was analyzed for an inflammation index ratio of interleukin (IL)-1β/IL-1 receptor antagonist (ra) using enzyme-linked immunosorbent assays. All clinical parameters improved significantly (P <0.005) from baseline in both groups with no differences between groups at any time point. CAL decreased 17% (0.9 ± 0.8 mm) and 13% (0.7 ± 0.9 mm) in SRP + MM and 11% (0.7 ± 1.1 mm) and 21% (1.2 ± 0.9 mm) in SRP at 6 and 12 months, respectively. The odds of having BOP decreased 90% (down to 38% of patients) and 95% (26%) in SRP + MM and 82% (42%) and 82% (41%) in SRP at 6 and 12 months, respectively. IL-1β/IL-1ra decreased a significant 61% (P = 0.009) only in SRP + MM at 6 months. SRP of inflamed moderate pockets during 6-month PMT, with or without MMs, improves CALs, along with PDs and BOP over a 1-year period. The use of MMs did not result in an additional benefit over SRP alone.

  15. Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?

    Science.gov (United States)

    Del Paggio, J C; Azariah, B; Sullivan, R; Hopman, W M; James, F V; Roshni, S; Tannock, I F; Booth, C M

    2017-01-01

    The European Society for Medical Oncology (ESMO) recently released a magnitude of clinical benefit scale (ESMO-MCBS) for systemic therapies for solid cancers. Here, we evaluate contemporary randomized controlled trials (RCTs) against the proposed ESMO thresholds for meaningful clinical benefit. RCTs evaluating systemic therapy for breast cancer, nonsmall cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic cancer published 2011-2015 were reviewed. Data were abstracted regarding trial characteristics and outcomes, and these were applied to the ESMO-MCBS. We also determined whether RCTs were designed to detect an effect that would meet clinical benefit as defined by the ESMO-MCBS. About 277 eligible RCTs were included (40% breast, 31% NSCLC, 22% CRC, 6% pancreas). Median sample size was 532 and 83% were funded by industry. Among all 277 RCTs, the experimental therapy was statistically superior to the control arm in 138 (50%) trials: results of only 31% (43/138) of these trials met the ESMO-MCBS clinical benefit threshold. RCTs with curative intent were more likely to meet clinically meaningful thresholds than those with palliative intent [61% (19/31) versus 22% (24/107), P meet ESMO-MCBS thresholds. Less than one-third of contemporary RCTs with statistically significant results meet ESMO thresholds for meaningful clinical benefit, and this represents only 15% of all published trials. Investigators, funding agencies, regulatory agencies, and industry should adopt more stringent thresholds for meaningful benefit in the design of future RCTs.

  16. Determining optimal sample sizes for multi-stage randomized clinical trials using value of information methods.

    Science.gov (United States)

    Willan, Andrew; Kowgier, Matthew

    2008-01-01

    Traditional sample size calculations for randomized clinical trials depend on somewhat arbitrarily chosen factors, such as Type I and II errors. An effectiveness trial (otherwise known as a pragmatic trial or management trial) is essentially an effort to inform decision-making, i.e., should treatment be adopted over standard? Taking a societal perspective and using Bayesian decision theory, Willan and Pinto (Stat. Med. 2005; 24:1791-1806 and Stat. Med. 2006; 25:720) show how to determine the sample size that maximizes the expected net gain, i.e., the difference between the cost of doing the trial and the value of the information gained from the results. These methods are extended to include multi-stage adaptive designs, with a solution given for a two-stage design. The methods are applied to two examples. As demonstrated by the two examples, substantial increases in the expected net gain (ENG) can be realized by using multi-stage adaptive designs based on expected value of information methods. In addition, the expected sample size and total cost may be reduced. Exact solutions have been provided for the two-stage design. Solutions for higher-order designs may prove to be prohibitively complex and approximate solutions may be required. The use of multi-stage adaptive designs for randomized clinical trials based on expected value of sample information methods leads to substantial gains in the ENG and reductions in the expected sample size and total cost.

  17. Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

    Science.gov (United States)

    Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

    2017-10-01

    Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study

  18. A randomized controlled trial of Minnesota day clinic treatment of alcoholics

    DEFF Research Database (Denmark)

    Grønbaek, Morten; Nielsen, Bent

    2007-01-01

    dependence were included in a 1-year clinical trial. MEASUREMENTS: Self-reported drinking pattern and the seven composite scores from the addiction severity index (ASI). FINDINGS: A total of 42 (57%) and 45 (61%) patients (P > 0.05) completed the Minnesota treatment and public treatment, respectively......AIM: To compare the Minnesota day clinic treatment with the traditional public psychosocial treatment. DESIGN: Randomized controlled trial. SETTING: Public out-patient alcohol clinic and privately funded Minnesota day clinic in Denmark. PARTICIPANTS: A total of 148 individuals with alcohol......% of the patients treated according to the Minnesota model were abstainers, while this was the case for 43% of the patients treated in the public out-patient alcohol clinic (P = 0.249). There were insignificant differences in the seven ASI scores. CONCLUSIONS: Twelve months after onset of treatment, the Minnesota...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of ...

  20. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Directory of Open Access Journals (Sweden)

    Marleine Azar

    Full Text Available Confidence that randomized controlled trial (RCT results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP is the primary trials journal amongst American Psychological Association (APA journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1 adequacy of primary outcome analysis definitions; (2 registration status; and, (3 among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals.Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1 adequacy of outcome analysis definitions in the published report, (2 whether the RCT was registered prior to enrolling patients, and (3 adequacy of outcome registration.Of 70 RCTs reviewed, 12 (17.1% adequately defined primary or secondary outcome analyses, whereas 58 (82.3% had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7% registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029. The proportion of registered trials in JCCP (55.7% was comparable to behavioral medicine journals (52.6%; p = 0.709.The quality of published outcome analysis definitions and trial registrations in JCCP is

  1. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology.

    Science.gov (United States)

    Azar, Marleine; Riehm, Kira E; McKay, Dean; Thombs, Brett D

    2015-01-01

    Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Eligible RCTs were published in JCCP in 2013-2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). The quality of published outcome analysis definitions and trial registrations in JCCP is

  2. Transparency of Outcome Reporting and Trial Registration of Randomized Controlled Trials Published in the Journal of Consulting and Clinical Psychology

    Science.gov (United States)

    Azar, Marleine; Riehm, Kira E.; McKay, Dean; Thombs, Brett D.

    2015-01-01

    Background Confidence that randomized controlled trial (RCT) results accurately reflect intervention effectiveness depends on proper trial conduct and the accuracy and completeness of published trial reports. The Journal of Consulting and Clinical Psychology (JCCP) is the primary trials journal amongst American Psychological Association (APA) journals. The objectives of this study were to review RCTs recently published in JCCP to evaluate (1) adequacy of primary outcome analysis definitions; (2) registration status; and, (3) among registered trials, adequacy of outcome registrations. Additionally, we compared results from JCCP to findings from a recent study of top psychosomatic and behavioral medicine journals. Methods Eligible RCTs were published in JCCP in 2013–2014. For each RCT, two investigators independently extracted data on (1) adequacy of outcome analysis definitions in the published report, (2) whether the RCT was registered prior to enrolling patients, and (3) adequacy of outcome registration. Results Of 70 RCTs reviewed, 12 (17.1%) adequately defined primary or secondary outcome analyses, whereas 58 (82.3%) had multiple primary outcome analyses without statistical adjustment or undefined outcome analyses. There were 39 (55.7%) registered trials. Only two trials registered prior to patient enrollment with a single primary outcome variable and time point of assessment. However, in one of the two trials, registered and published outcomes were discrepant. No studies were adequately registered as per Standard Protocol Items: Recommendation for Interventional Trials guidelines. Compared to psychosomatic and behavioral medicine journals, the proportion of published trials with adequate outcome analysis declarations was significantly lower in JCCP (17.1% versus 32.9%; p = 0.029). The proportion of registered trials in JCCP (55.7%) was comparable to behavioral medicine journals (52.6%; p = 0.709). Conclusions The quality of published outcome analysis

  3. A better alternative to stratified permuted block design for subject randomization in clinical trials.

    Science.gov (United States)

    Zhao, Wenle

    2014-12-30

    Stratified permuted block randomization has been the dominant covariate-adaptive randomization procedure in clinical trials for several decades. Its high probability of deterministic assignment and low capacity of covariate balancing have been well recognized. The popularity of this sub-optimal method is largely due to its simplicity in implementation and the lack of better alternatives. Proposed in this paper is a two-stage covariate-adaptive randomization procedure that uses the block urn design or the big stick design in stage one to restrict the treatment imbalance within each covariate stratum, and uses the biased-coin minimization method in stage two to control imbalances in the distribution of additional covariates that are not included in the stratification algorithm. Analytical and simulation results show that the new randomization procedure significantly reduces the probability of deterministic assignments, and improve the covariate balancing capacity when compared to the traditional stratified permuted block randomization. Copyright © 2014 John Wiley & Sons, Ltd.

  4. Do omega-3 polyunsaturated Fatty acids prevent cardiovascular disease? A review of the randomized clinical trials.

    Science.gov (United States)

    Kimmig, Lucas M; Karalis, Dean G

    2013-01-01

    Fish oil is rich in the omega-3 polyunsaturated fatty acids (PUFAs) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Numerous epidemiological studies and several large randomized clinical trials have shown that modest doses of omega-3 PUFAs significantly reduce the risk of unstable angina, myocardial infarction, and sudden cardiac death as well as death in coronary artery disease and heart failure patients. Based on the scientific evidence, the American Heart Association (AHA) has recommended all individuals eat fish at least twice a week to prevent cardiovascular disease. For individuals with coronary artery disease, the recommended dose of omega-3 PUFAs is 1 g of EPA and DHA daily. To lower triglyceride levels, much higher doses are needed. However, more recent randomized clinical trials have questioned the cardiovascular benefits of fish oil. These studies have contributed to the uncertainty health care providers face when recommending omega-3 PUFA supplementation according to clinical guidelines. The purpose of this review is to examine the randomized clinical trials and scientific evidence between omega-3 PUFAs and cardiovascular outcomes to better understand the current role of omega-3 PUFAs in improving cardiovascular health.

  5. [What does "p" mean at conclusion of a test of hypothesis in a randomized controlled clinical trial of superiority?].

    Science.gov (United States)

    Marubini, Ettore; Gallo, Fabio; Pizzamiglio, Sara; Verderio, Paolo

    2006-10-01

    The aim of this statistical note, the sixth in the series, is to introduce the rationale of the test of hypothesis suitable for comparing the effect of two treatments in a randomized controlled clinical trial of superiority. The presentation takes advantage of the analogy with a criminal trial debate based upon circumstantial evidence in an Italian Court. The results of three randomized controlled clinical trials: ISIS-1, AIMS and RESTORE are introduced and proper ways for their interpretation are suggested.

  6. Methodological and ethical aspects of randomized controlled clinical trials in minors with malignant diseases.

    Science.gov (United States)

    Rothenberger, Lillian G; Henschel, Andreas Dirk; Schrey, Dominik; Becker, Andreas; Boos, Joachim

    2011-10-01

    Due to the new European regulations for pediatric medications, future clinical trials will include an increasing number of minors. It is therefore important to reconsider and evaluate recent methodological and ethical aspects of clinical trials in minors. The following questions were investigated: How are randomized controlled clinical trials (RCTs) performed in practice? Do investigators take into consideration biomedical ethical principles, explicated for example by Beauchamp and Childress, when planning and conducting a trial? The study was conducted in a descriptive manner. A systematic, algorithm-guided search focusing on RCTs in minors with malignant diseases was carried out in PubMed. One-thousand-nine-hundred-sixty-two publications from 2001 to 2005 were randomized in sequence. The first 1,000 publications were screened according to a priori defined inclusion criteria. One hundred seventy-five publications met the criteria and were reviewed using the SIGN methodological checklist (2004), the CONSORT Statement (2001, section Methods, items 3-12) and indicators for ethical aspects. Seventeen publications were checked by two raters. Information on randomization and blinding was often equivocal. The publications were mainly rated positive for the criteria of the SIGN checklist, and mostly rated negative for the additional items of the CONSORT Statement. Regarding the ethical principles, only few contributions were found in the publications. Inter-rater reliability was good. In the publications analyzed, we found only limited information concerning methods and reflections on ethical principles of the trials. Improvements are thus necessary and possible. We suggest how such trials and their respective publications can be optimized for these aspects. Copyright © 2011 Wiley-Liss, Inc.

  7. Transition rates from schizotypal disorder to psychotic disorder for first-contact patients included in the OPUS trial. A randomized clinical trial of integrated treatment and standard treatment

    DEFF Research Database (Denmark)

    Nordentoft, Merete; Thorup, Anne; Petersen, Lone

    2006-01-01

    Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms.......Only a few randomized clinical trials have tested the effect on transition rates of intervention programs for patients with sub-threshold psychosis-like symptoms....

  8. Randomized Clinical Trials on Acupuncture in Korean Literature: A Systematic Review

    Directory of Open Access Journals (Sweden)

    Jae Cheol Kong

    2009-01-01

    Full Text Available The aim of this systematic review was to summarize randomized clinical trials (RCTs assessing the effectiveness of acupuncture as published in Korean literature. Systematic searches were conducted on eight Korean medical databases. Manual searches were also conducted through eight major Korean medical journals. The methodological quality was assessed using a Jadad score. Studies evaluating needle acupuncture or auricular acupuncture (AA with or without electrical stimulation were considered if they were sham or placebo-controlled or controlled against a comparative intervention. We also excluded acupuncture as an adjuvant to other treatments and other forms of acupuncture were excluded. Seven hundred and nine possibly relevant studies were identified and 10 RCTs were included. The methodological quality of the trials was generally poor. Manual acupuncture was compared to placebo acupuncture in four studies of patients with chronic low back pain, shoulder pain, premenstrual syndrome and allergic rhinitis. Three studies tested AA (two trials and electroacupuncture (one trial against no treatment, while three trials compared acupuncture with other active therapeutic controls. The methodological limitations of the included trials make their contribution to the current clinical evidence of acupuncture somewhat limited. The trial for premenstrual syndrome, shoulder pain and chronic low back pain added a limited contribution among those included RCTs. However, well-designed RCTs of acupuncture with a rigorous methodology are in progress or have been completed in Korea and will contribute to establish or contribute to the current progress of research in this field.

  9. Randomized Clinical Trials of Gene Transfer for Heart Failure with Reduced Ejection Fraction.

    Science.gov (United States)

    Penny, William F; Hammond, H Kirk

    2017-05-01

    Despite improvements in drug and device therapy for heart failure, hospitalization rates and mortality have changed little in the past decade. Randomized clinical trials using gene transfer to improve function of the failing heart are the focus of this review. Four randomized clinical trials of gene transfer in heart failure with reduced ejection fraction (HFrEF) have been published. Each enrolled patients with stable symptomatic HFrEF and used either intracoronary delivery of a virus vector or endocardial injection of a plasmid. The initial CUPID trial randomized 14 subjects to placebo and 25 subjects to escalating doses of adeno-associated virus type 1 encoding sarcoplasmic reticulum calcium ATPase (AAV1.SERCA2a). AAV1.SERCA2a was well tolerated, and the high-dose group met a 6 month composite endpoint. In the subsequent CUPID-2 study, 243 subjects received either placebo or the high dose of AAV1.SERCA2a. AAV1.SERCA2a administration, while safe, failed to meet the primary or any secondary endpoints. STOP-HF used plasmid endocardial injection of stromal cell-derived factor-1 to promote stem-cell recruitment. In a 93-subject trial of patients with ischemic etiology heart failure, the primary endpoint (symptoms and 6 min walk distance) failed, but subgroup analyses showed improvements in subjects with the lowest ejection fractions. A fourth trial randomized 14 subjects to placebo and 42 subjects to escalating doses of adenovirus-5 encoding adenylyl cyclase 6 (Ad5.hAC6). There were no safety concerns, and patients in the two highest dose groups (combined) showed improvements in left ventricular function (left ventricular ejection fraction and -dP/dt). The safety data from four randomized clinical trials of gene transfer in patients with symptomatic HFrEF suggest that this approach can be conducted with acceptable risk, despite invasive delivery techniques in a high-risk population. Additional trials are necessary before the approach can be endorsed for clinical

  10. Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

    Science.gov (United States)

    Johnson, Anna M; Jones, Sara B; Duncan, Pamela W; Bushnell, Cheryl D; Coleman, Sylvia W; Mettam, Laurie H; Kucharska-Newton, Anna M; Sissine, Mysha E; Rosamond, Wayne D

    2018-01-26

    Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board

  11. Comparison of Elaeagnus angustifolia Extract and Sildenafil Citrate on Female Orgasmic Disorders: A Randomized Clinical Trial

    OpenAIRE

    Akbarzadeh, Marzieh; Zeinalzadeh, Sanaz; Zolghadri, Jaleh; Mohagheghzadeh, Abdolali; Faridi, Pouya; Sayadi, Mehrab

    2014-01-01

    Background Orgasmic disorder can create a feeling of deprivation and failure and provide mental problems, incompatibility and marital discord. This study aimed to compare the effects of Elaeagnus angustifolia flower extract and sildenafil citrate on female orgasmic disorder in women in 2013. Methods In this randomized clinical trial, 125 women between 18-40 years old who suffered from orgasmic disorder were divided into three E. angustifolia, sildenafil citrate and control groups. The data we...

  12. Assessment of the quality of reporting of randomized clinical trials in paediatric dentistry journals.

    Science.gov (United States)

    Al-Namankany, Abeer A; Ashley, Paul; Moles, David R; Parekh, Susan

    2009-09-01

    Reporting of randomized controlled trials (RCTs) should be of high quality to support the conclusions reached by the authors. Poor-quality reporting has been associated with an overestimation in intervention efficacy. Within the field of paediatric dentistry, no study has assessed the quality of reporting. The aim of this study was to assess published RCTs in paediatric dental journals between 1985 and 2006 for: (i) whether quality of reporting allows readers to assess the validity of trials; and (ii) whether quality of reporting has improved since the introduction of the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Hand search of the main paediatric dentistry journals; inclusion criteria were: the trial was performed on children, and RCT. CONSORT guidelines were made into an operational checklist. Trials published between 1985 and 1997, and between 1998 and 2006 were compared to determine any improvement since the publication of the CONSORT guidelines. One hundred and seventy-three of 5635 articles met the inclusion criteria. Reporting quality was poor overall and showed heterogeneity. It had improved slightly since the publication of CONSORT. Few trials were reported adequately. The quality of reporting of clinical trials is poor, and often not adequate to allow readers to assess trial validity. Overall quality of reporting has not substantially improved since the publication of CONSORT.

  13. Huperzine A for Alzheimer's disease: a systematic review and meta-analysis of randomized clinical trials.

    Directory of Open Access Journals (Sweden)

    Guoyan Yang

    Full Text Available Huperzine A is a Chinese herb extract used for Alzheimer's disease. We conducted this review to evaluate the beneficial and harmful effect of Huperzine A for treatment of Alzheimer's disease.We searched for randomized clinical trials (RCTs of Huperzine A for Alzheimer's disease in PubMed, Cochrane Library, and four major Chinese electronic databases from their inception to June 2013. We performed meta-analyses using RevMan 5.1 software. (Protocol ID: CRD42012003249.20 RCTs including 1823 participants were included. The methodological quality of most included trials had a high risk of bias. Compared with placebo, Huperzine A showed a significant beneficial effect on the improvement of cognitive function as measured by Mini-Mental State Examination (MMSE at 8 weeks, 12 weeks and 16 weeks, and by Hastgawa Dementia Scale (HDS and Wechsler Memory Scale (WMS at 8 weeks and 12 weeks. Activities of daily living favored Huperzine A as measured by Activities of Daily Living Scale (ADL at 6 weeks, 12 weeks and 16 weeks. One trial found Huperzine A improved global clinical assessment as measured by Clinical Dementia Rating Scale (CDR. One trial demonstrated no significant change in cognitive function as measured by Alzheimer's disease Assessment Scale-Cognitive Subscale (ADAS-Cog and activity of daily living as measured by Alzheimer's disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL in Huperzine A group. Trials comparing Huperzine A with no treatment, psychotherapy and conventional medicine demonstrated similar findings. No trial evaluated quality of life. No trial reported severe adverse events of Huperzine A.Huperzine A appears to have beneficial effects on improvement of cognitive function, daily living activity, and global clinical assessment in participants with Alzheimer's disease. However, the findings should be interpreted with caution due to the poor methodological quality of the included trials.

  14. Therapeutic Effect of Virtual Reality on Post-Stroke Patients: Randomized Clinical Trial.

    Science.gov (United States)

    Pedreira da Fonseca, Erika; Ribeiro da Silva, Nildo Manoel; Pinto, Elen Beatriz

    2017-01-01

    The study aimed to check the therapeutic effect of virtual reality associated with conventional physiotherapy on gait balance and the occurrence of falls after a stroke. This was a randomized, blinded clinical trial conducted with post-stroke patients, randomized into two groups-treatment group and control group-and subjected to balance assessments by the Dynamic Gait Index and investigation of falls before and after 20 intervention sessions. Statistically significant difference was considered at P rehabilitation in post-stroke patients, with repercussions on the reduction of falls. Copyright © 2017 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  15. Clinical Trials

    Medline Plus

    Full Text Available ... participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional guidance on participating ...

  16. Clinical Trials

    Medline Plus

    Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...

  17. Clinical Trials

    Medline Plus

    Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at cc-prpl@cc.nih.gov or call ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... medical centers, and hospitals. ClinicalTrials.gov View a database of clinical studies (past and present) funded or ...

  19. Clinical Trials

    Medline Plus

    Full Text Available ... help produce reliable study results. Clinical trials are one of the final stages of a long and ... trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of lowering ...

  20. 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

  1. Does clinical equipoise apply to cluster randomized trials in health research?

    Science.gov (United States)

    2011-01-01

    This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial

  2. Some recent randomized clinical trials in the management of atrial fibrillation.

    Science.gov (United States)

    Wyse, D George

    2003-10-01

    It is not possible to review all the recent randomized clinical trials in management of atrial fibrillation. The author has chosen to select a few that illustrate key points. "Immediate" or "early" recurrence of atrial fibrillation after electrical cardioversion is an important part of inefficacy of drug therapy and more insight into the mechanisms of this phenomenon is needed. Two recent trials in which verapamil, a calcium channel blocker, and irbesartan, an angiotensin receptor blocking agent, added to a standard antiarrhythmic attenuated early recurrences of atrial fibrillation are of particular interest. Trials of drugs and pacing for maintenance of sinus rhythm continue to demonstrate only modest efficacy. Amiodarone, the most effective agent, is not markedly better and there are concerns about its adverse effect profile during long-term use. Other nonpharmacologic therapies have not yet been, but will need to be, evaluated in properly designed randomized clinical trials with clinically important end-points. The absence of a simple, highly effective treatment for the maintenance of sinus rhythm with few adverse effects has been part of the foundation for recent trials comparing the rate control strategy to the rhythm control strategy, particularly in the elderly patient. Six such trials have been completed and one is in progress. The data from these trials is quite consistent for the elderly patient with stroke risk factors and predominantly persistent atrial fibrillation: (1) any advantage for the rhythm control strategy remains unproven; (2) the rate control strategy has some clear advantages and should be considered more often as a primary approach in such patients; and (3) anticoagulation should not be discontinued in such high risk patients, even when it is felt that sinus rhythm has been maintained. Anticoagulation is under-utilized in this setting and alternatives to warfarin are badly needed. Trials in progress may be helpful in this regard. Finally

  3. Patient Engagement in Randomized Controlled Tai Chi Clinical Trials among the Chronically Ill.

    Science.gov (United States)

    Jiang, Dongsheng; Kong, Weihong; Jiang, Joanna J

    2017-01-01

    Physicians encounter various symptom-based complaints each day. While physicians strive to support patients with chronic illnesses, evidence indicates that patients who are actively involved in their health care have better health outcomes and sometimes lowers costs. This article is to analyze how patient engagement is described when complex interventions such as Tai Chi were delivered in Randomized Controlled clinical Trials (RCTs). It reviews the dynamic patient- physician relationship in chronic illness management and to illustrate the patient engagement process, using Tai Chi as an example intervention. RCTs are considered the gold standard in clinical research. This study is a qualitative analysis of RCTs using Tai Chi as an intervention. A systematic literature search was performed to identify quality randomized controlled clinical trials that investigated the effects of Tai Chi. Selected clinical trials were classified according to research design, intervention style, patient engagement, and outcomes. Patient engagement was classified based on levels of patient participation, compliance, and selfmanagement. The chronic health conditions included in this paper are Parkinson's disease, polyneuropathy, hypertension, stroke, chronic insomnia, chronic heart failure, fibromyalgia, osteoarthritis, central obesity, depression, deconditioning in the elderly, or being pre-clinically disabled. We found that patient engagement, as a concept, was not well defined in literature. It covers a wide range of related terms, such as patient involvement, participation, shared decision- making, patient activation, adherence, compliance, and self-management. Tai Chi, as a very complex practice system, is to balance all aspects of a patient's life; however, the level of patient engagement is difficult to describe using conventional clinical trial design. To accurately illustrate the effect of a complex intervention, novel research design must explore ways to measure patient

  4. A randomized clinical trial on the sealing of occlusal carious lesions

    DEFF Research Database (Denmark)

    Alves, Luana Severo; Giongo, Fernanda Cristina Mendes de Santa; Mua, Bruna

    2017-01-01

    of a cavity with no access allowing biofilm control. The maximum depth of the lesion was the middle third of the dentin thickness, as assessed by bitewing radiography. The teeth were randomly assigned to sealant treatment (n = 28) or restorative treatment (n = 26). Clinical and radiographic examinations were......This randomized clinical trial aimed to assess the efficacy of sealing occlusal carious lesions in permanent teeth. The sample consisted of 54 occlusal carious lesions in permanent molars and premolars of 49 patients aged 8-43 years (median: 19 years). The inclusion criteria comprised the presence...... performed after 1 year and after 3-4 years. The outcomes depended on the clinical performance of the sealant/restoration and the control of caries progression observed radiographically. Survival analysis was performed to assess success rates. Over the 3-4 years of monitoring, 2 sealants were totally lost, 1...

  5. [Some factors affecting treatment outcome in a randomized clinical trial of borderline patients].

    Science.gov (United States)

    Delaney, Jill C; Yeomans, Frank; Stone, Michael H; Haran, Catherine

    2008-01-01

    At the Personality Disorders Institute we have been investigating the efficacy of Transference-Focused Psychotherapy (TFP), a twice weekly manualized psychodynamic psychotherapy for borderline personality disorder compared to Dialectical Behavior Therapy (DBT) and Supportive Psychotherapy (SP) in a randomized clinical trial of 90 borderline patients. We will first present some developmental foundations of BPD, followed by a discussion of the theoretical foundations of TFP. We will then discuss patient characteristics that have an impact on outcome. We will present both clinical and empirical data in a discussion of individual cases that were representative of a sample of borderline patients treated in Transference-Focused Psychotherapy (TFP).

  6. Why cancer patients enter randomized clinical trials: exploring the factors that influence their decision.

    Science.gov (United States)

    Wright, James R; Whelan, Timothy J; Schiff, Susan; Dubois, Sacha; Crooks, Dauna; Haines, Patricia T; DeRosa, Diane; Roberts, Robin S; Gafni, Amiram; Pritchard, Kathleen; Levine, Mark N

    2004-11-01

    Few interventions have been designed and tested to improve recruitment to clinical trials in oncology. The multiple factors influencing patients' decisions have made the prioritization of specific interventions challenging. The present study was undertaken to identify the independent predictors of a cancer patient's decision to enter a randomized clinical trial. A list of factors from the medical literature was augmented with a series of focus groups involving cancer patients, physicians, and clinical research associates (CRAs). A series of questionnaires was developed with items based on these factors and were administered concurrently to 189 cancer patients, their physicians, and CRAs following the patient's decision regarding trial entry. Forward logistic regression modeling was performed using the items significantly correlated (by univariate analysis) with the decision to enter a clinical trial. A number of items were significantly correlated with the patient's decision. In the multivariate logistic regression model, the patient's perception of personal benefit was the most important, with an odds ratio (OR) of 3.08 (P decision-making process were also important. These included whether the CRA helped with the decision (OR = 1.71; P decision was hard for the patient to make (OR = 0.52; P decision-making process while respecting the need for information and patient autonomy may also lead to meaningful improvements in accrual.

  7. Effectiveness of papain gel in venous ulcer treatment: randomized clinical trial1

    Science.gov (United States)

    Rodrigues, Ana Luiza Soares; de Oliveira, Beatriz Guitton Renaud Baptista; Futuro, Débora Omena; Secoli, Silvia Regina

    2015-01-01

    OBJECTIVE: to assess the effectiveness of 2% papain gel compared to 2% carboxymethyl cellulose in the treatment of chronic venous ulcer patients. METHOD: randomized controlled clinical trial with 12-week follow-up. The sample consisted of 18 volunteers and 28 venous ulcers. In the trial group, 2% papain gel was used and, in the control group, 2% carboxymethyl cellulose gel. RESULTS: the trial group showed a significant reduction in the lesion area, especially between the fifth and twelfth week of treatment, with two healed ulcers and a considerable increase in the amount of epithelial tissue in the wound bed. CONCLUSION: 2% papain gel demonstrated greater effectiveness in the reduction of the lesion area, but was similar to 2% carboxymethyl cellulose gel regarding the reduction in the amount of exudate and devitalized tissue. Multicenter research is suggested to evidence the effectiveness of 2% papain gel in the healing of venous ulcers. UTN number: U1111-1157-2998 PMID:26155004

  8. Effectiveness of papain gel in venous ulcer treatment: randomized clinical trial.

    Science.gov (United States)

    Rodrigues, Ana Luiza Soares; de Oliveira, Beatriz Guitton Renaud Baptista; Futuro, Débora Omena; Secoli, Silvia Regina

    2015-01-01

    to assess the effectiveness of 2% papain gel compared to 2% carboxymethyl cellulose in the treatment of chronic venous ulcer patients. randomized controlled clinical trial with 12-week follow-up. The sample consisted of 18 volunteers and 28 venous ulcers. In the trial group, 2% papain gel was used and, in the control group, 2% carboxymethyl cellulose gel. the trial group showed a significant reduction in the lesion area, especially between the fifth and twelfth week of treatment, with two healed ulcers and a considerable increase in the amount of epithelial tissue in the wound bed. 2% papain gel demonstrated greater effectiveness in the reduction of the lesion area, but was similar to 2% carboxymethyl cellulose gel regarding the reduction in the amount of exudate and devitalized tissue. Multicenter research is suggested to evidence the effectiveness of 2% papain gel in the healing of venous ulcers. UTN number: U1111-1157-2998.

  9. Phytopharmaceutical treatment of anxiety, depression, and dementia in the elderly: evidence from randomized, controlled clinical trials.

    Science.gov (United States)

    Kasper, Siegfried

    2015-06-01

    Based on subgroup analyses of randomized, controlled clinical trials, we review the efficacy of three phytopharmaceutical drugs, respectively of the corresponding active substances silexan® (WS® 1265, lavender oil) in anxiety disorders, WS® 5570 (Hypericum extract) in major depression, and EGb 761® (Ginkgo biloba extract) in Alzheimer, vascular, or mixed type dementia, in elderly patients aged ≥ 60 years. Four trials were eligible in each indication. Meta-analyses and analyses based on pooled raw data showed that the three drugs were significantly superior to placebo in the elderly subset, and that their treatment effects reflected in the main outcome measures (Hamilton Anxiety scale, Hamilton Depression scale, Neuropsychiatric Inventory) were comparable with those observed in the original trials without age restrictions. The results confirm the efficacy of the three herbal active substances in elderly patients of ≥ 60 years of age. In anxiety, depression, and dementia, they thus represent efficacious and well-tolerated alternatives to synthetic drugs.

  10. Mobile applications for handheld devices to screen and randomize acute stroke patients in clinical trials.

    Science.gov (United States)

    Qureshi, Ai; Connelly, B; Abbott, Ei; Maland, E; Kim, J; Blake, J

    2012-08-01

    The availability of internet connectivity and mobile application software used by low-power handheld devices makes smart phones of unique value in time-sensitive clinical trials. Trial-specific applications can be downloaded by investigators from various mobile software distribution platforms or web applications delivered over HTTP. The Antihypertensive Treatment in Acute Cerebral Hemorrhage (ATACH) II investigators in collaboration with MentorMate released the ATACH-II Patient Recruitment mobile application available on iPhone, Android, and Blackberry in 2011. The mobile application provides tools for pre-screening, assessment of eligibility, and randomization of patients. Since the release of ATACH-II mobile application, the CLEAR-IVH (Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage) trial investigators have also adopted such a mobile application. The video-conferencing capabilities of the most recent mobile devices open up additional opportunities to involve central coordinating centers in the recruitment process in real time.

  11. Quality of Reporting of Randomized Clinical Trials in Tai Chi Interventions—A Systematic Review

    Directory of Open Access Journals (Sweden)

    Jing-Yi Li

    2011-01-01

    Full Text Available Objectives. To evaluate the reporting quality of published randomized clinical trials (RCTs in the Tai Chi literature following the publication of the CONSORT guidelines in 2001. Data Sources. The OVID MEDLINE and PUBMED databases. Review Methods. To survey the general characteristics of Tai Chi RCTs in the literature, we included any report if (i it was an original report of the trial; (ii its design was RCT; (iii one of the treatments being tested was Tai Chi; and (iv it was in English. In addition, we assessed the reporting quality of RCTs that were published between 2002 and 2007, using a modified CONSORT checklist of 40 items. The adequate description of Tai Chi interventions in these trials was examined against a 10-item checklist adapted from previous reviews. Results. The search yielded 31 Tai Chi RCTs published from 2002 to 2007 and only 11 for 1992–2001. Among trials published during 2002–2007, the most adequately reported criteria were related to background, participant eligibility and interpretation of the study results. Nonetheless, the most poorly reported items were associated with randomization allocation concealment, implementation of randomization and the definitions of period of recruitment and follow-up. In addition, only 23% of RCTs provided adequate details of Tai Chi intervention used in the trials. Conclusion. The findings in this review indicated that the reporting quality of Tai Chi intervention trials is sub-optimal. Substantial improvement is required to meet the CONSORT guidelines and allow assessment of the quality of evidence. We believe that not only investigators, but also journal editors, reviewers and funding agencies need to follow the CONSORT guidelines to improve the standards of research and strengthen the evidence base for Tai Chi and for complementary and alternative medicine.

  12. Inference of median difference based on the Box-Cox model in randomized clinical trials.

    Science.gov (United States)

    Maruo, K; Isogawa, N; Gosho, M

    2015-05-10

    In randomized clinical trials, many medical and biological measurements are not normally distributed and are often skewed. The Box-Cox transformation is a powerful procedure for comparing two treatment groups for skewed continuous variables in terms of a statistical test. However, it is difficult to directly estimate and interpret the location difference between the two groups on the original scale of the measurement. We propose a helpful method that infers the difference of the treatment effect on the original scale in a more easily interpretable form. We also provide statistical analysis packages that consistently include an estimate of the treatment effect, covariance adjustments, standard errors, and statistical hypothesis tests. The simulation study that focuses on randomized parallel group clinical trials with two treatment groups indicates that the performance of the proposed method is equivalent to or better than that of the existing non-parametric approaches in terms of the type-I error rate and power. We illustrate our method with cluster of differentiation 4 data in an acquired immune deficiency syndrome clinical trial. Copyright © 2015 John Wiley & Sons, Ltd.

  13. Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial.

    Science.gov (United States)

    Ito, Masaya; Okumura, Yasuyuki; Horikoshi, Masaru; Kato, Noriko; Oe, Yuki; Miyamae, Mitsuhiro; Hirabayashi, Naotsugu; Kanie, Ayako; Nakagawa, Atsuo; Ono, Yutaka

    2016-03-18

    The unified protocol for the transdiagnostic treatment of emotional disorders is a promising treatment approach that could be applicable to a broad range of mental disorders, including depressive, anxiety, trauma-related, and obsessive-compulsive disorders. However, no randomized controlled trial has been conducted to verify the efficacy of the unified protocol on the heterogeneous clinical population with depressive and anxiety disorders. The trial was designed as a single-center, assessor-blinded, randomized, 20-week, parallel-group superiority study in order to compare the efficacy of the combination of unified protocol and treatment-as-usual versus waiting-list with treatment-as-usual for patients with depressive and/or anxiety disorders. The primary outcome was depression at 21 weeks, assessed by the 17-item version of the GRID-Hamilton Rating Scale for Depression. Estimated minimum sample size was 27 participants in each group. We will also examine the treatment mechanisms, treatment processes, and neuropsychological correlates. The results of this study will clarify the efficacy of the unified protocol for depressive and anxiety disorders, and the treatment mechanism, process, and neurological correlates for the effectiveness of the unified protocol. If its efficacy can be confirmed, the unified protocol may be of high clinical value for Japan, a country in which cognitive behavioral treatment has not yet been widely adopted. ClinicalTrials.gov NCT02003261 (registered on December 2, 2013).

  14. Induced Hypertension for Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage: A Randomized Clinical Trial.

    Science.gov (United States)

    Gathier, Celine S; van den Bergh, Walter M; van der Jagt, Mathieu; Verweij, Bon H; Dankbaar, Jan Willem; Müller, Marcella C; Oldenbeuving, Annemarie W; Rinkel, Gabriel J E; Slooter, Arjen J C

    2018-01-01

    Induced hypertension is widely used to treat delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage, but a literature review shows that its presumed effectiveness is based on uncontrolled case-series only. We here report clinical outcome of aneurysmal subarachnoid hemorrhage patients with DCI included in a randomized trial on the effectiveness of induced hypertension. Aneurysmal subarachnoid hemorrhage patients with clinical symptoms of DCI were randomized to induced hypertension or no induced hypertension. Risk ratios for poor outcome (modified Rankin Scale score >3) at 3 months, with 95% confidence intervals, were calculated and adjusted for age, clinical condition at admission and at time of DCI, and amount of blood on initial computed tomographic scan with Poisson regression analysis. The trial aiming to include 240 patients was ended, based on lack of effect on cerebral perfusion and slow recruitment, when 21 patients had been randomized to induced hypertension, and 20 patients to no hypertension. With induced hypertension, the adjusted risk ratio for poor outcome was 1.0 (95% confidence interval, 0.6-1.8) and the risk ratio for serious adverse events 2.1 (95% confidence interval, 0.9-5.0). Before this trial, the effectiveness of induced hypertension for DCI in aneurysmal subarachnoid hemorrhage patients was unknown because current literature consists only of uncontrolled case series. The results from our premature halted trial do not add any evidence to support induced hypertension and show that this treatment can lead to serious adverse events. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01613235. © 2017 American Heart Association, Inc.

  15. Clinical pharmacists on medical care of pediatric inpatients: a single-center randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Chuan Zhang

    Full Text Available OBJECTIVE: To explore the best interventions and working patterns of clinical pharmacists in pediatrics and to determine the effectiveness of clinical pharmacists in pediatrics. METHODS: We conducted a randomized controlled trial of 160 pediatric patients with nerve system disease, respiratory system disease or digestive system disease, who were randomly allocated into two groups, with 80 in each group. Interventions by clinical pharmacists in the experimental group included answering questions of physicians and nurses, giving advice on treating patients, checking prescriptions and patient counseling at discharge. In the control group, patients were treated without clinical pharmacist interventions. RESULTS: Of the 109 interventions provided by clinical pharmacists during 4 months, 47 were consultations for physicians and nurses, 31 were suggestions of treatment, with 30 accepted by physicians (96.77% and 31 were medical errors found in 641 prescriptions. Five adverse drug reactions were submitted to the adverse drug reaction monitoring network, with three in the experimental group and two in the control group. The average length of stay (LOS for patients with respiratory system diseases in the experimental group was 6.45 days, in comparison with 10.83 days in the control group, which was statistically different (p value<0.05; Average drug compliance rate in the experimental group was 81.41%, in comparison with 70.17% of the control group, which was statistically different (p value<0.05. Cost of drugs and hospitalization and rate of readmission in two weeks after discharge in the two groups were not statistically different. CONCLUSION: Participation by clinical pharmacists in the pharmacotherapy of pediatric patients can reduce LOS of patients with respiratory system disease and improve compliance rate through discharge education, showing no significant effects on prevention of ADR, reduction of cost of drugs and hospitalization and readmission

  16. Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder

    Directory of Open Access Journals (Sweden)

    Crawford Sybil

    2008-09-01

    Full Text Available Abstract Background Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. Methods and design This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174 will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake of the intervention effect on weight change will also be examined. Discussion Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. Trial registration NCT00572520

  17. Clinical Trials

    Medline Plus

    Full Text Available ... Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and ... drugs, and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical ...

  18. Clinical Trials

    Medline Plus

    Full Text Available ... you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking ... people will need to travel or stay in hospitals to take part in clinical trials. For example, ...

  19. Correction: PAIS: paracetamol (acetaminophen in stroke; protocol for a randomized, double blind clinical trial. [ISCRTN74418480

    Directory of Open Access Journals (Sweden)

    Kappelle L Jaap

    2008-11-01

    Full Text Available Abstract Background The Paracetamol (Acetaminophen In Stroke (PAIS study is a phase III multicenter, double blind, randomized, placebo-controlled clinical trial of high-dose acetaminophen in patients with acute stroke. The trial compares treatment with a daily dose of 6 g acetaminophen, started within 12 hours after the onset of symptoms, with matched placebo. The purpose of this study is to assess whether treatment with acetaminophen for 3 days will result in improved functional outcome through a modest reduction in body temperature and prevention of fever. The previously planned statistical analysis based on a dichotomization of the scores on the modified Rankin Scale (mRS may not make the most efficient use of the available baseline information. Therefore, the planned primary analysis of the PAIS study has been changed from fixed dichotomization of the mRS to a sliding dichotomy analysis. Methods Instead of taking a single definition of good outcome for all patients, the definition is tailored to each individual patient's baseline prognosis on entry into the trial. Conclusion The protocol change was initiated because of both advances in statistical approaches and to increase the efficiency of the trial by improving statistical power. Trial Registration Current Controlled Trials [ISCRTN74418480

  20. Endothelial cell loss and visual outcome of deep anterior lamellar keratoplasty versus penetrating keratoplasty: a randomized multicenter clinical trial

    NARCIS (Netherlands)

    Cheng, Y.Y.; Visser, N.; Schouten, J.S.A.G.; Wijdh, R.J.; Pels, E.; Cleynenbreugel, H. van; Eggink, C.A.; Zaal, M.J.; Rijneveld, W.J.; Nuijts, R.M.

    2011-01-01

    OBJECTIVE: To compare endothelial cell (EC) loss, visual and refractive outcomes, and complications after deep anterior lamellar keratoplasty (DALK) and penetrating keratoplasty (PK). DESIGN: Randomized, multicenter clinical trial. PARTICIPANTS: Fifty-six eyes of 56 patients with a corneal stromal

  1. Endothelial Cell Loss and Visual Outcome of Deep Anterior Lamellar Keratoplasty versus Penetrating Keratoplasty : A Randomized Multicenter Clinical Trial

    NARCIS (Netherlands)

    Cheng, Yanny Y. Y.; Visser, Nienke; Schouten, Jan S.; Wijdh, Robert-Jan; Pels, Elisabeth; van Cleynenbreugel, Hugo; Eggink, Catharina A.; Zaal, Michel J. W.; Rijneveld, Wilhelmina J.; Nuijts, Rudy M. M. A.

    Objective: To compare endothelial cell (EC) loss, visual and refractive outcomes, and complications after deep anterior lamellar keratoplasty (DALK) and penetrating keratoplasty (PK). Design: Randomized, multicenter clinical trial. Participants: Fifty-six eyes of 56 patients with a corneal stromal

  2. Quality of vision after femtosecond laser-assisted descemet stripping endothelial keratoplasty and penetrating keratoplasty: a randomized, multicenter clinical trial

    NARCIS (Netherlands)

    Cheng, Y.Y.; Berg, T.J. van den; Schouten, J.S.A.G.; Pels, E.; Wijdh, R.J.; Cleynenbreugel, H. van; Eggink, C.A.; Rijneveld, W.J.; Nuijts, R.M.

    2011-01-01

    PURPOSE: To compare the quality of vision (straylight and contrast sensitivity) after femtosecond laser-assisted Descemet stripping endothelial keratoplasty (FS DSEK) and penetrating keratoplasty (PK). DESIGN: Prospective, randomized clinical trial. METHODS: setting: Multicenter (5 ophthalmic

  3. Quality of Vision After Femtosecond Laser-Assisted Descemet Stripping Endothelial Keratoplasty and Penetrating Keratoplasty : A Randomized, Multicenter Clinical Trial

    NARCIS (Netherlands)

    Cheng, Yanny Y. Y.; van den Berg, Tom J. T. P.; Schouten, Jan S.; Pels, Elisabeth; Wijdh, Robert-Jan; van Cleynenbreugel, Hugo; Eggink, Catharina A.; Rijneveld, Wilhelmina J.; Nuijts, Rudy M. M. A.

    2011-01-01

    PURPOSE: To compare the quality of vision (straylight and contrast sensitivity) after femtosecond laser-assisted Descemet stripping endothelial keratoplasty (FS DSEK) and penetrating keratoplasty (PK). DESIGN: Prospective, randomized clinical trial. METHODS: SETTING: Multicenter (5 ophthalmic

  4. Treatment of diffuse diabetic maculopathy with intravitreal triamcinolone and laser photocoagulation: randomized clinical trial with morphological and functional evaluation

    National Research Council Canada - National Science Library

    Gil, Alberto Luiz; Azevedo, Mirela Jobim de; Tomasetto, Giovani Generali; Muniz, Carlos Henrique Gervini; Lavinsky, Jacó

    2011-01-01

    .... The purpose of this double blind randomized clinical trial was to compare the treatment of diffuse diabetic macular edema with intravitreal triamcinolone or laser in type 2 diabetes mellitus patients...

  5. Digital versus analogue preoperative planning of total hip arthroplasties: a randomized clinical trial of 210 total hip arthroplasties.

    NARCIS (Netherlands)

    The, B.; Verdonschot, N.J.J.; Horn, J.R. van; Ooijen, PM van; Diercks, R.L.

    2007-01-01

    The objective of this randomized clinical trial was to compare the clinical and technical results of digital preoperative planning for primary total hip arthroplasties with analogue planning. Two hundred and ten total hip arthroplasties were randomized. All plans were constructed on standardized

  6. Digital versus analogue preoperative planning of total hip arthroplasties - A randomized clinical trial of 210 total hip arthroplasties

    NARCIS (Netherlands)

    The, Bertram; Verdonschot, Nico; van Horn, Jim R.; van Ooijen, Peter M. A.; Diercks, Ron L.

    The objective of this randomized clinical trial was to compare the clinical and technical results of digital preoperative planning for primary total hip arthroplasties with analogue planning. Two hundred and ten total hip arthroplasties were randomized. All plans were constructed on standardized

  7. RARtool: A MATLAB Software Package for Designing Response-Adaptive Randomized Clinical Trials with Time-to-Event Outcomes.

    Science.gov (United States)

    Ryeznik, Yevgen; Sverdlov, Oleksandr; Wong, Weng Kee

    2015-08-01

    Response-adaptive randomization designs are becoming increasingly popular in clinical trial practice. In this paper, we present RARtool , a user interface software developed in MATLAB for designing response-adaptive randomized comparative clinical trials with censored time-to-event outcomes. The RARtool software can compute different types of optimal treatment allocation designs, and it can simulate response-adaptive randomization procedures targeting selected optimal allocations. Through simulations, an investigator can assess design characteristics under a variety of experimental scenarios and select the best procedure for practical implementation. We illustrate the utility of our RARtool software by redesigning a survival trial from the literature.

  8. Randomized clinical trials in orthodontics are rarely registered a priori and often published late or not at all.

    Science.gov (United States)

    Papageorgiou, Spyridon N; Antonoglou, Georgios N; Sándor, George K; Eliades, Theodore

    2017-01-01

    A priori registration of randomized clinical trials is crucial to the transparency and credibility of their findings. Aim of this study was to assess the frequency with which registered and completed randomized trials in orthodontics are published. We searched ClinicalTrials.gov and ISRCTN for registered randomized clinical trials in orthodontics that had been completed up to January 2017 and judged the publication status and date of registered trials using a systematic protocol. Statistical analysis included descriptive statistics, chi-square or Fisher exact tests, and Kaplan-Meier survival estimates. From the 266 orthodontic trials registered up to January 2017, 80 trials had been completed and included in the present study. Among these 80 included trials, the majority (76%) were registered retrospectively, while only 33 (41%) were published at the time. The median time from completion to publication was 20.1 months (interquartile range: 9.1 to 31.6 months), while survival analysis indicated that less than 10% of the trials were published after 5 years from their completion. Finally, 22 (28%) of completed trials remain unpublished even after 5 years from their completion. Publication rates of registered randomized trials in orthodontics remained low, even 5 years after their completion date.

  9. Whole body vibration for older persons: an open randomized, multicentre, parallel, clinical trial

    Directory of Open Access Journals (Sweden)

    Sitjà-Rabert Mercè

    2011-12-01

    Full Text Available Abstract Background Institutionalized older persons have a poor functional capacity. Including physical exercise in their routine activities decreases their frailty and improves their quality of life. Whole-body vibration (WBV training is a type of exercise that seems beneficial in frail older persons to improve their functional mobility, but the evidence is inconclusive. This trial will compare the results of exercise with WBV and exercise without WBV in improving body balance, muscle performance and fall prevention in institutionalized older persons. Methods/Design An open, multicentre and parallel randomized clinical trial with blinded assessment. 160 nursing home residents aged over 65 years and of both sexes will be identified to participate in the study. Participants will be centrally randomised and allocated to interventions (vibration or exercise group by telephone. The vibration group will perform static/dynamic exercises (balance and resistance training on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm over a six-week training period (3 sessions/week. The exercise group will perform the same exercise protocol but without a vibration stimuli platform. The primary outcome measure is the static/dynamic body balance. Secondary outcomes are muscle strength and, number of new falls. Follow-up measurements will be collected at 6 weeks and at 6 months after randomization. Efficacy will be analysed on an intention-to-treat (ITT basis and 'per protocol'. The effects of the intervention will be evaluated using the "t" test, Mann-Witney test, or Chi-square test, depending on the type of outcome. The final analysis will be performed 6 weeks and 6 months after randomization. Discussion This study will help to clarify whether WBV training improves body balance, gait mobility and muscle strength in frail older persons living in nursing homes. As far as we know, this will be the first study to evaluate the efficacy of WBV for the

  10. A randomized clinical trial of two emergency contraceptive pill regimens in a Ugandan population.

    Science.gov (United States)

    Byamugisha, Josaphat K; Mirembe, Florence M; Faxelid, Elisabeth; Tumwesigye, Nazarius M; Gemzell-Danielsson, Kristina

    2010-05-01

    Recent trials on emergency contraception (EC) have indicated that levonorgestrel (LNG) used alone has fewer side-effects and is more efficacious than the Yuzpe regimen (high dose combined oral contraceptive pills). However, the experienced side-effects and acceptability may vary between different groups or societies. The primary objective of this study was to determine side-effects and acceptability of two emergency contraceptive pill (ECP) regimens among users in Kampala, Uganda. Randomized clinical trial. A total of 337 women were enrolled in a double blind randomized clinical trial. Women requesting ECPs within 72 hours after unprotected sexual intercourse received either LNG or the Yuzpe regimen. The women returned for follow-up after three days and a follow-up interview was performed after one year. Levonorgestrel had significantly fewer side-effects than the Yuzpe regimen (p < 0.001). There was a significant association between having worries about the method and experiencing side-effects (p < 0.001). Most women (81%) were prime users of EC. The majority would recommend ECP to other clients. Levonorgestrel is a superior option to the Yuzpe regimen and should be promoted as the recommended ECP. Having worries about ECP may influence experience of the side-effects. Correct information is critical in promotion of ECP use.

  11. Chronological bias in randomized clinical trials arising from different types of unobserved time trends.

    Science.gov (United States)

    Tamm, M; Hilgers, R-D

    2014-01-01

    In clinical trials patients are commonly recruited sequentially over time incurring the risk of chronological bias due to (unobserved) time trends. To minimize the risk of chronological bias, a suitable randomization procedure should be chosen. Considering different time trend scenarios, we aim at a detailed evaluation of the extent of chronological bias under permuted block randomization in order to provide recommendations regarding the choice of randomization at the design stage of a clinical trial and to assess the maximum extent of bias for a realized sequence in the analysis stage. For the assessment of chronological bias we consider linear, logarithmic and stepwise trends illustrating typical changes during recruitment in clinical practice. Bias and variance of the treatment effect estimator as well as the empirical type I error rate when applying the t-test are investigated. Different sample sizes, block sizes and strengths of time trends are considered. Using large block sizes, a notable bias exists in the estimate of the treatment effect for specific sequences. This results in a heavily inflated type I error for realized worst-case sequences and an enlarged mean squared error of the treatment effect estimator. Decreasing the block size restricts these effects of time trends. Already applying permuted block randomization with two blocks instead of the random allocation rule achieves a good reduction of the mean squared error and of the inflated type I error. Averaged over all sequences, the type I error of the t-test is far below the nominal significance level due to an overestimated variance. Unobserved time trends can induce a strong bias in the treatment effect estimate and in the test decision. Therefore, already in the design stage of a clinical trial a suitable randomization procedure should be chosen. According to our results, small block sizes should be preferred, but also medium block sizes are sufficient to restrict chronological bias to an

  12. Comparing a stratified treatment strategy with the standard treatment in randomized clinical trials

    DEFF Research Database (Denmark)

    Sun, Hong; Bretz, Frank; Gerke, Oke

    2016-01-01

    The increasing emergence of predictive markers for different treatments in the same patient population allows us to define stratified treatment strategies. We consider randomized clinical trials that compare a standard treatment with a new stratified treatment strategy that divides the study...... population into subgroups receiving different treatments. Because the new strategy may not be beneficial in all subgroups, we consider in this paper an intermediate approach that establishes a treatment effect in a subset of patients built by joining several subgroups. The approach is based on the simple...

  13. Pharmacologic prophylaxis for postoperative atrial tachyarrhythmia in general thoracic surgery: evidence from randomized clinical trials.

    Science.gov (United States)

    Sedrakyan, Artyom; Treasure, Tom; Browne, John; Krumholz, Harlan; Sharpin, Carlos; van der Meulen, Jan

    2005-05-01

    Atrial tachyarrhythmia is the most common complication after general thoracic surgery and is associated with significant morbidity, longer hospital stay, and higher costs. We sought to determine whether the use of antiarrhythmic medications is associated with a reduced rate of postoperative atrial tachyarrhythmia. MEDLINE, EMBASE, Cochrane Database of clinical trials (1980-2003), and reference lists of relevant articles were searched for randomized controlled trials with placebo control, general thoracic patients, and noncombined and prophylactic use of the medications. Search, data abstraction, and analyses were performed and confirmed by at least 2 authors. A fixed-effects model was used to perform meta-analyses. There were 11 unique trials (total n = 1294) that met the inclusion criteria. Calcium-channel blockers and beta-blockers reduced the risk of atrial tachyarrhythmia in 4 and 2 trials, respectively (relative risk of 0.50 and 95% confidence interval of 0.34-0.73; relative risk of 0.40 and 95% confidence interval of 0.17-0.95, respectively). However, beta-blockers tended to increase the risk of pulmonary edema (relative risk, 2.15; 95% confidence interval, 0.74-6.23). Magnesium tested in one unblinded trial also reduced the risk of atrial tachyarrhythmia (relative risk, 0.4; 95% confidence interval, 0.21-0.78). On the other hand, digitalis preparations were found to be harmful because they increased the risk of atrial tachyarrhythmia in 3 trials (relative risk, 1.51; 95% confidence interval, 1.00-2.28). Finally, 2 other medications, flecainide and amiodarone, were each tested in a single small trial, and their effects were associated with great uncertainty. Calcium-channel blockers and beta-blockers are effective in reducing postoperative atrial tachyarrhythmia. The use of these medications should be individualized, and possible adverse events of beta-blockers should be taken into account. Randomized clinical trials do not support the use of digitalis in

  14. Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis

    Directory of Open Access Journals (Sweden)

    Lazo-Langner Alejandro

    2012-01-01

    Full Text Available Abstract Background To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of randomized trials, we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients undergoing orthopedic surgery. Methods Using a cost-effectiveness approach from a clinical perspective (i.e. risk benefit analysis we compared thromboprophylaxis with warfarin, low molecular weight heparin, unfractionated heparin, fondaparinux or ximelagatran in patients undergoing major orthopedic surgery, with sub-analyses according to surgery type. Proportions and variances of events defining risk (major bleeding and benefit (thrombosis averted were obtained through a meta-analysis and used to define beta distributions. Monte Carlo simulations were conducted and used to calculate incremental risks, benefits, and risk-benefit ratios. Finally, net clinical benefit was calculated for all replications across a range of risk-benefit acceptability thresholds, with a reference range obtained by estimating the case fatality rate - ratio of thrombosis to bleeding. Results The analysis showed that compared to placebo ximelagatran was superior to other options but final results were influenced by type of surgery, since ximelagatran was superior in total knee replacement but not in total hip replacement. Conclusions Using simulation and economic techniques we demonstrate a method that allows comparing multiple competing interventions in the absence of randomized trials with multiple arms by determining the option with the best risk-benefit profile. It can be helpful in clinical decision making since it incorporates risk, benefit, and personal risk acceptance.

  15. Garlic powder intake and cardiovascular risk factors: a meta-analysis of randomized controlled clinical trials.

    Science.gov (United States)

    Kwak, Jin Sook; Kim, Ji Yeon; Paek, Ju Eun; Lee, You Jin; Kim, Haeng-Ran; Park, Dong-Sik; Kwon, Oran

    2014-12-01

    Although preclinical studies suggest that garlic has potential preventive effects on cardiovascular disease (CVD) risk factors, clinical trials and reports from systematic reviews or meta-analyses present inconsistent results. The contradiction might be attributed to variations in the manufacturing process that can markedly influence the composition of garlic products. To investigate this issue further, we performed a meta-analysis of the effects of garlic powder on CVD risk factors. We searched PubMed, Cochrane, Science Direct and EMBASE through May 2014. A random-effects meta-analysis was performed on 22 trials reporting total cholesterol (TC), 17 trials reporting LDL cholesterol (LDL-C), 18 trials reporting HDL cholesterol (HDL-C), 4 trials reporting fasting blood glucose (FBG), 9 trials reporting systolic blood pressure (SBP) and 10 trials reporting diastolic blood pressure (DBP). The overall garlic powder intake significantly reduced blood TC and LDL-C by -0.41 mmol/L (95% confidence interval [CI], -0.69, -0.12) (-15.83 mg/dL [95% CI, -26.64, -4.63]) and -0.21 mmol/L (95% CI, -0.40, -0.03) (-8.11 mg/dL [95% CI, -15.44, -1.16]), respectively. The mean difference in the reduction of FBG levels was -0.96 mmol/L (95% CI, -1.91, -0.01) (-17.30 mg/dL [95% CI, -34.41, -0.18]). Evidence for SBP and DBP reduction in the garlic supplementation group was also demonstrated by decreases of -4.34 mmHg (95% CI, -8.38, -0.29) and -2.36 mmHg (95% CI, -4.56, -0.15), respectively. This meta-analysis provides consistent evidence that garlic powder intake reduces the CVD risk factors of TC, LDL-C, FBG and BP.

  16. Evaluation of the Cochrane tool for assessing risk of bias in randomized clinical trials

    DEFF Research Database (Denmark)

    Jørgensen, L; Paludan-Müller, A. S.; Laursen, David

    2016-01-01

    Background: The Cochrane risk of bias tool for randomized clinical trials was introduced in 2008 and has frequently been commented on and used in systematic reviews. We wanted to evaluate the tool by reviewing published comments on its strengths and challenges and by describing and analysing how...... the tool is applied to both Cochrane and non-Cochrane systematic reviews. Methods: A review of published comments (searches in PubMed, The Cochrane Methodology Register and Google Scholar) and an observational study (100 Cochrane and 100 non-Cochrane reviews from 2014). Results: Our review included 68...... in non-Cochrane reviews (31/100). Both types of reviews frequently implemented the tool in non-recommended ways. Most Cochrane reviews planned to use risk of bias assessments as basis for sensitivity analyses (70 %), but only a minority conducted such analyses (19 %) because, in many cases, few trials...

  17. Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial

    DEFF Research Database (Denmark)

    Maiers, Michele; Evans, Roni; Hartvigsen, Jan

    2015-01-01

    Spinal manipulative therapy (SMT) and exercise have demonstrated effectiveness for neck pain (NP). Adverse events (AE) reporting in trials, particularly among elderly participants, is inconsistent and challenges informed clinical decision making. This paper provides a detailed report of AE...... experienced by elderly participants in a randomized comparative effectiveness trial of SMT and exercise for chronic NP. AE data, consistent with CONSORT recommendations, were collected on elderly participants who received 12 weeks of SMT with home exercise, supervised plus home exercise, or home exercise...... at home. Eight serious, non-related AE also occurred. Musculoskeletal AE were common among elderly participants receiving SMT and exercise interventions for NP. As such, they should be expected and discussed when developing care plans....

  18. Scapular-focused treatment in patients with shoulder impingement syndrome: a randomized clinical trial.

    Science.gov (United States)

    Struyf, F; Nijs, J; Mollekens, S; Jeurissen, I; Truijen, S; Mottram, S; Meeusen, R

    2013-01-01

    The purpose of this clinical trial is to compare the effectiveness of a scapular-focused treatment with a control therapy in patients with shoulder impingement syndrome. Therefore, a randomized clinical trial with a blinded assessor was used in 22 patients with shoulder impingement syndrome. The primary outcome measures included self-reported shoulder disability and pain. Next, patients were evaluated regarding scapular positioning and shoulder muscle strength. The scapular-focused treatment included stretching and scapular motor control training. The control therapy included stretching, muscle friction, and eccentric rotator cuff training. Main outcome measures were the shoulder disability questionnaire, diagnostic tests for shoulder impingement syndrome, clinical tests for scapular positioning, shoulder pain (visual analog scale; VAS), and muscle strength. A large clinically important treatment effect in favor of scapular motor control training was found in self-reported disability (Cohen's d = 0.93, p = 0.025), and a moderate to large clinically important improvement in pain during the Neer test, Hawkins test, and empty can test (Cohen's d 0.76, 1.04, and 0.92, respectively). In addition, the experimental group demonstrated a moderate (Cohen's d = 0.67) improvement in self-experienced pain at rest (VAS), whereas the control group did not change. The effects were maintained at three months follow-up.

  19. Electrothermal arthroscopic capsulorrhaphy: old technology, new evidence. A multicenter randomized clinical trial.

    Science.gov (United States)

    Mohtadi, Nicholas G; Kirkley, Alexandra; Hollinshead, Robert M; McCormack, Robert; MacDonald, Peter B; Chan, Denise S; Sasyniuk, Treny M; Fick, Gordon H; Paolucci, Elizabeth Oddone

    2014-08-01

    Radiofrequency technology for shoulder instability was rapidly adopted despite limited clinical evidence and a poor understanding of its indications. Reports of serious adverse events followed, leading to its abandonment. This paper presents findings from a multicenter randomized clinical trial evaluating the safety and efficacy of electrothermal arthroscopic capsulorrhaphy (ETAC) compared with open inferior capsular shift (ICS) and reviews the role of randomized trials in adopting new technology. Patients (>14 years) diagnosed with multidirectional instability or multidirectional laxity with anteroinferior instability and failed nonoperative treatment were enrolled. Patients with bone lesions or labral, biceps anchor, or full-thickness rotator cuff tears were excluded intraoperatively. Outcomes included Western Ontario Shoulder Instability Index, function and recurrent instability at 2 years postoperatively, and surgical times. Fifty-four subjects (mean age, 23 years; 37 women) were randomized to ETAC (n = 28) or open ICS (n = 26). The groups were comparable at baseline, except for external rotation at the side. At 2 years postoperatively, there were no statistically or clinically significant differences between groups for the Western Ontario Shoulder Instability Index (P = .71), American Shoulder and Elbow Surgeons score (P = .43), Constant score (P = .43), and active range of motion. Recurrent instability was not statistically different (ETAC, 2; open, 4; P = .41). ETAC (23 minutes) was significantly shorter than open ICS (59 minutes) (P new technology before widespread clinical use. Copyright © 2014 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  20. Clinical hypnosis in the treatment of postmenopausal hot flashes: a randomized controlled trial.

    Science.gov (United States)

    Elkins, Gary R; Fisher, William I; Johnson, Aimee K; Carpenter, Janet S; Keith, Timothy Z

    2013-03-01

    The use of estrogen and progesterone to manage vasomotor symptoms (ie, hot flashes and night sweats) has declined because of concerns about their risks, and there is an increased interest in alternate, effective, and low-risk treatments. This study reports the results of a randomized controlled trial of clinical hypnosis for treating vasomotor symptoms among postmenopausal women. This is a randomized, single-blind, controlled, clinical trial involving 187 postmenopausal women reporting a minimum of seven hot flashes per day (or at least 50 hot flashes a week) at baseline between December 2008 and April 2012. Eligible participants received five weekly sessions of either clinical hypnosis or structured-attention control. Primary outcomes were hot flash frequency (subjectively and physiologically recorded) and hot flash score assessed by daily diaries on weeks 2 to 6 and week 12. Secondary outcomes included measures of hot flash-related daily interference, sleep quality, and treatment satisfaction. In a modified intent-to-treat analysis that included all randomized participants who provided data, reported subjective hot flash frequency from baseline to week 12 showed a mean reduction of 55.82 (74.16%) hot flashes for the clinical hypnosis intervention versus a mean reduction of 12.89 (17.13%) hot flashes for controls (P hypnosis intervention as compared with 3.53 (15.38%) for controls (P hypnosis and 0.88 (9.94%) for controls (P hypnosis results in significant reductions in self-reported and physiologically measured hot flashes and hot flash scores in postmenopausal women.

  1. A randomized, controlled clinical trial: the effect of mindfulness-based cognitive therapy on generalized anxiety disorder among Chinese community patients: protocol for a randomized trial.

    Science.gov (United States)

    Wong, Samuel Y S; Mak, Winnie W S; Cheung, Eliza Y L; Ling, Candy Y M; Lui, Wacy W S; Tang, W K; Wong, Rebecca L P; Lo, Herman H M; Mercer, Stewart; Ma, Helen S W

    2011-11-29

    Research suggests that an eight-week Mindfulness-Based Cognitive Therapy (MBCT) program may be effective in the treatment of generalized anxiety disorders. Our objective is to compare the clinical effectiveness of the MBCT program with a psycho-education programme and usual care in reducing anxiety symptoms in people suffering from generalized anxiety disorder. A three armed randomized, controlled clinical trial including 9-month post-treatment follow-up is proposed. Participants screened positive using the Structure Clinical Interview for DSM-IV (SCID) for general anxiety disorder will be recruited from community-based clinics. 228 participants will be randomly allocated to the MBCT program plus usual care, psycho-education program plus usual care or the usual care group. Validated Chinese version of instruments measuring anxiety and worry symptoms, depression, quality of life and health service utilization will be used. Our primary end point is the change of anxiety and worry score (Beck Anxiety Inventory and Penn State Worry Scale) from baseline to the end of intervention. For primary analyses, treatment outcomes will be assessed by ANCOVA, with change in anxiety score as the baseline variable, while the baseline anxiety score and other baseline characteristics that significantly differ between groups will serve as covariates. This is a first randomized controlled trial that compare the effectiveness of MBCT with an active control, findings will advance current knowledge in the management of GAD and the way that group intervention can be delivered and inform future research. Unique Trail Number (assigned by Centre for Clinical Trails, Clinical Trials registry, The Chinese University of Hong Kong): CUHK_CCT00267.

  2. A randomized, controlled clinical trial: the effect of mindfulness-based cognitive therapy on generalized anxiety disorder among Chinese community patients: protocol for a randomized trial

    Directory of Open Access Journals (Sweden)

    Wong Samuel YS

    2011-11-01

    Full Text Available Abstract Background Research suggests that an eight-week Mindfulness-Based Cognitive Therapy (MBCT program may be effective in the treatment of generalized anxiety disorders. Our objective is to compare the clinical effectiveness of the MBCT program with a psycho-education programme and usual care in reducing anxiety symptoms in people suffering from generalized anxiety disorder. Methods A three armed randomized, controlled clinical trial including 9-month post-treatment follow-up is proposed. Participants screened positive using the Structure Clinical Interview for DSM-IV (SCID for general anxiety disorder will be recruited from community-based clinics. 228 participants will be randomly allocated to the MBCT program plus usual care, psycho-education program plus usual care or the usual care group. Validated Chinese version of instruments measuring anxiety and worry symptoms, depression, quality of life and health service utilization will be used. Our primary end point is the change of anxiety and worry score (Beck Anxiety Inventory and Penn State Worry Scale from baseline to the end of intervention. For primary analyses, treatment outcomes will be assessed by ANCOVA, with change in anxiety score as the baseline variable, while the baseline anxiety score and other baseline characteristics that significantly differ between groups will serve as covariates. Conclusions This is a first randomized controlled trial that compare the effectiveness of MBCT with an active control, findings will advance current knowledge in the management of GAD and the way that group intervention can be delivered and inform future research. Unique Trail Number (assigned by Centre for Clinical Trails, Clinical Trials registry, The Chinese University of Hong Kong: CUHK_CCT00267

  3. Conjunctival Autograft Alone or Combined With Adjuvant Beta-Radiation? A Randomized Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Arruda Viani, Gustavo, E-mail: gusviani@gmail.com [Department of Radiation Oncology, Marilia Medical School, Marilia, Sao Paulo (Brazil); Carrara Fonseca, Ellen [Department of Radiation Oncology, Marilia Medical School, Marilia, Sao Paulo (Brazil); Department of Ophthalmology, Marilia Medical School, Marilia, Sao Paulo (Brazil); De Fendi, Ligia Issa [Department of Ophthalmology, Marilia Medical School, Marilia, Sao Paulo (Brazil); Melani Rocha, Eduardo [Department of Ophthalmology, School of Medicine of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto (Brazil)

    2012-03-01

    Purpose: To evaluate the effectiveness and safety of postoperative low single-dose of beta-irradiation ({beta}-RT) in pterygium comparing conjunctival autograft (CAG) surgery with CAG plus adjuvant {beta}-RT in a randomized clinical trial. Methods: This trial was designed as a prospective, randomized, single-center study. Surgery was performed in all cases according to the CAG technique. One hundred and eight pterygia were postoperatively randomized to CAG + {beta}-RT or CAG alone. In the case of {beta}-RT, a (90) Sr eye applicator was used to deliver 10 Gy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment, both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. Results: Between February 2008 and September 2008, 116 eyes with primary pterygium were operated on according to the trial protocol. Adjuvant treatment was performed within 24 h postoperatively. Eight patients were lost to follow-up, resulting in 108 patients who could be analyzed. At a mean follow-up of 18 months (range, 8-33), in the 54 eyes randomized to receive CAG + {beta}-RT, 5 relapses occurred compared with 12 recurrences in the 54 eyes in CAG, for a crude control rate of 90.8 % vs. 78%; p = 0.032, respectively. The treatment complications as hyperemia, total dehiscence of the autograft and dellen were significantly more frequent in the CAG (p < 0.05). The arm of {beta}-RT resulted in better cosmetic results and improves of symptoms than CAG. Conclusions: A low single-dose of {beta}-RT of 10 Gy after CAG surgery was a simple, effective, and safe treatment that reduced the risk of primary pterygium recurrence, improved symptoms after surgery, resulting in a better cosmetic effect than only CAG.

  4. Non-pharmacological care for patients with generalized osteoarthritis: design of a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Cornelissen Jessica

    2010-07-01

    Full Text Available Abstract Background Non-pharmacological treatment (NPT is a useful treatment option in the management of hip or knee osteoarthritis. To our knowledge however, no studies have investigated the effect of NPT in patients with generalized osteoarthritis (GOA. The primary aim of this study is to compare the effectiveness of two currently existing health care programs with different intensity and mode of delivery on daily functioning in patients with GOA. The secondary objective is to compare the cost-effectiveness of both interventions. Methods/Design In this randomized, single blind, clinical trial with active controls, we aim to include 170 patients with GOA. The experimental intervention consist of six self-management group sessions provided by a multi-disciplinary team (occupational therapist, physiotherapist, dietician and specialized nurse. The active control group consists of two group sessions and four sessions by telephone, provided by a specialized nurse and physiotherapist. Both therapies last six weeks. Main study outcome is daily functioning during the first year after the treatment, assessed on the Health Assessment Questionnaire. Secondary outcomes are health related quality of life, specific complaints, fatigue, and costs. Illness cognitions, global perceived effect and self-efficacy, will also be assessed for a responder analysis. Outcome assessments are performed directly after the intervention, after 26 weeks and after 52 weeks. Discussion This article describes the design of a randomized, single blind, clinical trial with a one year follow up to compare the costs and effectiveness of two non-pharmacological interventions with different modes of delivery for patients with GOA. Trial registration Dutch Trial Register NTR2137

  5. Transvaginal hybrid NOTES cholecystectomy--results of a randomized clinical trial after 6 months.

    Science.gov (United States)

    Bulian, Dirk Rolf; Knuth, Jurgen; Cerasani, Nicola; Lange, Jonas; Ströhlein, Michael Alfred; Sauerwald, Axel; Heiss, Markus Maria

    2014-08-01

    For cholecystectomy (CHE), both the needlescopic three-trocar technique with 2-3-mm instruments (needlescopic cholecystectomy (NC)) and the umbilically assisted transvaginal technique with rigid instruments (transvaginal cholecystectomy (TVC)) have been established for further reduction of the trauma remaining from laparoscopy. To compare the further outcome of both techniques for elective CHE in female patients, we analyzed the secondary end points of a prospective randomized single-center trial (needlescopic versus transvaginal cholecystectomy (NATCH) trial; ClinicalTrials.gov Identifier: NCT0168577), in particular, satisfaction with aesthetics, overall satisfaction, abdominal pain, and incidence of trocar hernias postoperatively at both 3 and 6 months. After 3 months, the domains "satisfaction" and "pain" of the German version of the Female Sexual Function Index (FSFI-d) were additionally evaluated to detect respective complications. A gynecological control examination was conducted in all TVC patients after 6 months. Forty patients were equally randomized into the therapy and the control groups between February 2010 and June 2012. No significant differences were found for overall satisfaction with the surgical result, abdominal pain, sexual function, and the rate of trocar hernias. However, aesthetics were rated significantly better by TVC patients both after 3 and after 6 months (P = 0.004 and P < 0.001). There were no postoperative pathological gynecological findings. Following TVC, there is a significantly better aesthetic result as compared to NC, even at 3 and 6 months after the procedure. No difference was found for sexual function.

  6. Clinical Trials

    Medline Plus

    Full Text Available ... The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT was already in common ...

  7. Adequacy of published oncology randomized controlled trials to provide therapeutic details needed for clinical application.

    Science.gov (United States)

    Duff, Jennifer M; Leather, Helen; Walden, Edmund O; LaPlant, Kourtney D; George, Thomas J

    2010-05-19

    Randomized controlled trials (RCTs) improve clinical care through evidence-based results. Guidelines exist for RCT result reporting, but specific details of therapeutic administration promote clinical application and reproduction of the trial design. We assess the reporting methodology in RCTs published in major oncology journals. Ten essential elements of RCT reporting were identified and included drug name, dose, route, cycle length, maximum number of cycles, premedication, growth factor support, patient monitoring parameters, and dosing adjustments for hematologic and organ-specific toxicity. All therapy-based oncology RCTs published between 2005 and 2008 in the New England Journal of Medicine (NEJM), Journal of Clinical Oncology (JCO), Journal of the National Cancer Institute (JNCI), Blood, and Cancer were analyzed for inclusion of these 10 elements. Of 339 identified articles, 262 were included in the final analysis (165 from JCO, 31 from NEJM, 27 from Cancer, 20 from JNCI, and 19 from Blood). Premedication, growth factor support, and dose adjustments for toxicities were each reported less than half of the time. Only 30 articles (11%) met the main objective of complete data reporting (ie, all 10 essential elements) and was highest in JNCI (5/20; 25%), followed by Cancer (5/27; 18%), JCO (18/165; 11%), Blood (1/19; 5%), and NEJM (1/31; 3%). The presence of an online appendix did not substantially improve complete reporting. RCTs published in major oncology journals do not consistently report essential therapeutic details necessary for translation of the trial findings to clinical practice. Potential solutions to improve reporting include modification of submission guidelines, use of online appendices, and providing open access to trial protocols.

  8. Clinical Trials

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    Full Text Available ... review data from a clinical trial for safety problems or differences in results among different groups. The DSMB also reviews research results from other relevant studies. These results may ...

  9. Clinical Trials

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    Full Text Available ... or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that ...

  10. Clinical Trials

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    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are ...

  11. Clinical Trials

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    Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  12. Clinical Trials

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    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

  13. Clinical Trials

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    Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ... the new approach. You also will have the support of a team of health care providers, who ...

  14. Clinical Trials

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    Full Text Available ... States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are testing new medicines or medical devices. The FDA reviews applications for new medicines ...

  15. Clinical Trials

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    Full Text Available ... care providers might be part of your treatment team. They will monitor your health closely. You may ... taking part in a clinical trial. Your treatment team also may ask you to do other tasks. ...

  16. Clinical Trials

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ...

  17. Clinical Trials

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

  18. Clinical Trials

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    Full Text Available ... clinical trials are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees all research ...

  19. Clinical Trials

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    Full Text Available ... include factors such as a patient's age and gender, the type and stage of disease, and whether ... in a clinical trial, find out ahead of time about costs and coverage. You should learn about ...

  20. A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Results at One-Month Post- Release

    Science.gov (United States)

    Gordon, Michael S.; Schwartz, Robert P.; O’Grady, Kevin; Fitzgerald, Terrence T.; Wilson, Monique

    2008-01-01

    Background Despite its effectiveness, methadone maintenance is rarely provided in American correctional facilities. This study is the first randomized clinical trial in the US to examine the effectiveness of methadone maintenance treatment provided to prisoners with pre-incarceration heroin addiction. Methods A three-group randomized controlled trial was conducted between September 2003 and June 2005. Two hundred-eleven Baltimore pre-release inmates who were heroin dependent during the year prior to incarceration were enrolled in this study. Participants were randomly assigned to the following: Counseling Only: counseling in prison, with passive referral to treatment upon release (n = 70); Counseling + Transfer: counseling in prison with transfer to methadone maintenance treatment upon release (n = 70); and Counseling + Methadone: methadone maintenance and counseling in prison, continued in a community-based methadone maintenance program upon release (n = 71). Results Two hundred participants were located for follow-up interviews and included in the current analysis. The percentages of participants in each condition that entered community-based treatment were, respectively, Counseling Only 7.8%, Counseling + Transfer 50.0%, and Counseling + Methadone 68.6%, p prison appears to have beneficial short-term impact on community treatment entry and heroin use. This intervention may be able to fill an urgent treatment need for prisoners with heroin addiction histories. PMID:17628351

  1. Perioperative intravenous acetaminophen attenuates lipid peroxidation in adults undergoing cardiopulmonary bypass: a randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Frederic T Billings

    Full Text Available Cardiopulmonary bypass (CPB lyses erythrocytes and induces lipid peroxidation, indicated by increasing plasma concentrations of free hemoglobin, F2-isoprostanes, and isofurans. Acetaminophen attenuates hemeprotein-mediated lipid peroxidation, reduces plasma and urine concentrations of F2-isoprostanes, and preserves kidney function in an animal model of rhabdomyolysis. Acetaminophen also attenuates plasma concentrations of isofurans in children undergoing CPB. The effect of acetaminophen on lipid peroxidation in adults has not been studied. This was a pilot study designed to test the hypothesis that acetaminophen attenuates lipid peroxidation in adults undergoing CPB and to generate data for a clinical trial aimed to reduce acute kidney injury following cardiac surgery.In a prospective double-blind placebo-controlled clinical trial, sixty adult patients were randomized to receive intravenous acetaminophen or placebo starting prior to initiation of CPB and for every 6 hours for 4 doses. Acetaminophen concentrations measured 30 min into CPB and post-CPB were 11.9 ± 0.6 μg/mL (78.9 ± 3.9 μM and 8.7 ± 0.3 μg/mL (57.6 ± 2.0 μM, respectively. Plasma free hemoglobin increased more than 15-fold during CPB, and haptoglobin decreased 73%, indicating hemolysis. Plasma and urinary markers of lipid peroxidation also increased during CPB but returned to baseline by the first postoperative day. Acetaminophen reduced plasma isofuran concentrations over the duration of the study (P = 0.05, and the intraoperative plasma isofuran concentrations that corresponded to peak hemolysis were attenuated in those subjects randomized to acetaminophen (P = 0.03. Perioperative acetaminophen did not affect plasma concentrations of F2-isoprostanes or urinary markers of lipid peroxidation.Intravenous acetaminophen attenuates the increase in intraoperative plasma isofuran concentrations that occurs during CPB, while urinary markers were unaffected.ClinicalTrials.gov NCT

  2. Misreporting in a randomized clinical trial for smoking cessation in adolescents.

    Science.gov (United States)

    Lantini, Ryan; McGrath, Ashlee C; Stein, L A R; Barnett, Nancy P; Monti, Peter M; Colby, Suzanne M

    2015-06-01

    Misreporting smoking behavior is common among younger smokers participating in clinical trials for smoking cessation. This study focused on the prevalence of and factors associated with adolescent misreporting of smoking behaviors within the context of a randomized clinical trial for smoking cessation. Adolescent smokers (N=129) participated in a randomized clinical trial that compared two brief interventions for smoking cessation. Following the final (6-month) follow-up, a confidential, self-administered exit questionnaire examined the extent to which participants admitted to having misreported smoking quantity, frequency and/or consequences during the study. Factors associated with under- and over-reporting were compared to accurate-reporting. One in 4 adolescent smokers (25.6%) admitted to under-reporting during the study and 14.7% admitted to over-reporting; 10.9% of the adolescents admitted to both under- and over-reporting. Rates of admitted misreporting did not differ between treatment conditions or recruitment site. Compared to accurate-reporting, under- and over-reporting were significantly associated with home smoking environment and the belief among adolescents that the baseline interviewer wanted them to report smoking more or less than they actually smoked. Compared to accurate reporters, over-reporters were more likely to be non-White and to report being concerned with the confidentiality of their responses. A post-study confidential debriefing questionnaire can be a useful tool for estimating rates of misreporting and examining whether potential differences in misreporting might bias the interpretation of treatment effects. Future studies are needed to thoroughly examine potentially addressable reasons that adolescents misreport their smoking behavior and to develop methods for reducing misreporting. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial.

    Science.gov (United States)

    Goodman, Phyllis J; Tangen, Catherine M; Darke, Amy K; Arnold, Kathryn B; Hartline, JoAnn; Yee, Monica; Anderson, Karen; Caban-Holt, Allison; Christen, William G; Cassano, Patricia A; Lance, Peter; Klein, Eric A; Crowley, John J; Minasian, Lori M; Meyskens, Frank L

    2016-08-12

    The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled, prostate cancer prevention study funded by the National Cancer Institute and conducted by SWOG (Southwest Oncology Group). A total of 35,533 men were assigned randomly to one of four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, placebo + placebo). At the time of the trial's development, NIH had invested substantial resources in evaluating the potential benefits of these antioxidants. To capitalize on the knowledge gained from following a large cohort of healthy, aging males on the effects of selenium and/or vitamin E, ancillary studies with other disease endpoints were solicited. Four ancillary studies were added. Each drew from the same population but had independent objectives and an endpoint other than prostate cancer. These studies fell into two categories: those prospectively enrolling and following participants (studies of Alzheimer's disease and respiratory function) and those requiring a retrospective medical record review after a reported event (cataracts/age-related macular degeneration and colorectal screening). An examination of the challenges and opportunities of adding ancillary studies is provided. The impact of the ancillary studies on adherence to SELECT was evaluated using a Cox proportional hazards model. While the addition of ancillary studies appears to have improved participant adherence to the primary trial, this did not come without added complexity. Activation of the ancillary studies happened after the SELECT randomizations had begun resulting in accrual problems to some of the studies. Study site participation in the ancillary trials varied greatly and depended on the interest of the study site principal investigator. Procedures for each were integrated into the primary trial and all monitoring was done by the SELECT Data and Safety Monitoring Committee. The impact of the early

  4. A novel design for randomized immuno-oncology clinical trials with potentially delayed treatment effects

    Directory of Open Access Journals (Sweden)

    Pei He

    2015-10-01

    Full Text Available The semi-parametric proportional hazards model is widely adopted in randomized clinical trials with time-to-event outcomes, and the log-rank test is frequently used to detect a potential treatment effect. Immuno-oncology therapies pose unique challenges to the design of a trial as the treatment effect may be delayed, which violates the proportional hazards assumption, and the log-rank test has been shown to markedly lose power under the non-proportional hazards setting. A novel design and analysis approach for immuno-oncology trials is proposed through a piecewise treatment effect function, which is capable of detecting a potentially delayed treatment effect. The number of events required for the trial will be determined to ensure sufficient power for both the overall log-rank test without a delayed effect and the test beyond the delayed period when such a delay exists. The existence of a treatment delay is determined by a likelihood ratio test with resampling. Numerical results show that the proposed design adequately controls the Type I error rate, has a minimal loss in power under the proportional hazards setting and is markedly more powerful than the log-rank test with a delayed treatment effect.

  5. Many randomized clinical trials may not be justified: a cross-sectional analysis of the ethics and science of randomized clinical trials.

    Science.gov (United States)

    De Meulemeester, Julie; Fedyk, Mark; Jurkovic, Lucas; Reaume, Michael; Dowlatshahi, Dar; Stotts, Grant; Shamy, Michel

    2018-01-03

    We have proposed that three scientific criteria are important for the ethical justification of randomized clinical trials (RCTs): (1) they should be designed around a clear hypothesis; (2) uncertainty should exist around that hypothesis; (3) that uncertainty should be as established through a systematic review. We hypothesized that the majority of a sample of recently published RCTs would not explicitly incorporate these criteria, therefore rendering them potentially unjustified on scientific grounds. Cross-sectional analysis of all RCTs published in the New England Journal of Medicine and the Journal of the American Medical Association in 2015. Each article and protocol was reviewed for: (1) a clearly stated central hypothesis; (2) references to "equipoise," or "consensus;" (3) some indication of evidentiary uncertainty; (4) a meta-analysis or systematic review surrounding the hypothesis or study question. We included 208 RCT articles and 199 protocols. Among combined articles and protocols, 76% had a clearly stated hypothesis, 99% referenced some form of uncertainty, and 54% cited a relevant systematic review or meta-analysis. Only 44% of combined texts contained all three scientific criteria. There were few references to "equipoise" (10%) or "consensus" (11%), and those references to equipoise were most often inconsistent with accepted definitions. The majority of RCTs (56%) did not meet the three scientific criteria described previously and therefore may be scientifically and therefore ethically unjustified. We recommend that "equipoise," "clinical equipoise," and "lack of consensus" be abandoned as scientific criteria for RCTs and be replaced by an expectation that RCTs have a clearly stated, meaningful hypothesis around which uncertainty has been established through a systematic review of the literature. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  6. Using simulation pedagogy to teach clinical education skills: A randomized trial.

    Science.gov (United States)

    Holdsworth, Clare; Skinner, Elizabeth H; Delany, Clare M

    2016-05-01

    Supervision of students is a key role of senior physiotherapy clinicians in teaching hospitals. The objective of this study was to test the effect of simulated learning environments (SLE) on educators' self-efficacy in student supervision skills. A pilot prospective randomized controlled trial with concealed allocation was conducted. Clinical educators were randomized to intervention (SLE) or control groups. SLE participants completed two 3-hour workshops, which included simulated clinical teaching scenarios, and facilitated debrief. Standard Education (StEd) participants completed two online learning modules. Change in educator clinical supervision self-efficacy (SE) and student perceptions of supervisor skill were calculated. Between-group comparisons of SE change scores were analyzed with independent t-tests to account for potential baseline differences in education experience. Eighteen educators (n = 18) were recruited (SLE [n = 10], StEd [n = 8]). Significant improvements in SE change scores were seen in SLE participants compared to control participants in three domains of self-efficacy: (1) talking to students about supervision and learning styles (p = 0.01); (2) adapting teaching styles for students' individual needs (p = 0.02); and (3) identifying strategies for future practice while supervising students (p = 0.02). This is the first study investigating SLE for teaching skills of clinical education. SLE improved educators' self-efficacy in three domains of clinical education. Sample size limited the interpretation of student ratings of educator supervision skills. Future studies using SLE would benefit from future large multicenter trials evaluating its effect on educators' teaching skills, student learning outcomes, and subsequent effects on patient care and health outcomes.

  7. A 12-week randomized clinical trial investigating the potential for sucralose to affect glucose homeostasis.

    Science.gov (United States)

    Grotz, V Lee; Pi-Sunyer, Xavier; Porte, Daniel; Roberts, Ashley; Richard Trout, J

    2017-08-01

    The discovery of gut sweet taste receptors has led to speculations that non-nutritive sweeteners, including sucralose, may affect glucose control. A double-blind, parallel, randomized clinical trial, reported here and previously submitted to regulatory agencies, helps to clarify the role of sucralose in this regard. This was primarily an out-patient study, with 4-week screening, 12-week test, and 4-week follow-up phases. Normoglycemic male volunteers (47) consumed ∼333.3 mg encapsulated sucralose or placebo 3x/day at mealtimes. HbA1c, fasting glucose, insulin, and C-peptide were measured weekly. OGTTs were conducted in-clinic overnight, following overnight fasting twice during screening phase, twice during test phase, and once at follow-up. Throughout the study, glucose, insulin, C-peptide and HbA1c levels were within normal range. No statistically significant differences between sucralose and placebo groups in change from baseline for fasting glucose, insulin, C-peptide and HbA1c, no clinically meaningful differences in time to peak levels or return towards basal levels in OGTTs, and no treatment group differences in mean glucose, insulin, or C-peptide AUC change from baseline were observed. The results of other relevant clinical trials and studies of gastrointestinal sweet taste receptors are compared to these findings. The collective evidence supports that sucralose has no effect on glycemic control. Copyright © 2017 Heartland Food Products Group. Published by Elsevier Inc. All rights reserved.

  8. Functional relaxation as complementary therapy in irritable bowel syndrome: a randomized, controlled clinical trial.

    Science.gov (United States)

    Lahmann, Claas; Röhricht, Frank; Sauer, Nina; Noll-Hussong, Michael; Ronel, Joram; Henrich, Gerhard; von Arnim, Angela; Loew, Thomas

    2010-01-01

    Irritable bowel syndrome (IBS) is a frequently disabling and almost invariably distressing disease with a high overall prevalence. Numerous trials identified the importance of psychogenic and emotional etiological factors, and this is obvious in clinical practice. Although relaxation techniques are frequently recommended, there is still a lack of evidence for their efficacy in the management of IBS. This study therefore aims to determine the efficacy of functional relaxation (FR) in IBS. The subjects were 80 patients with IBS. Participants were randomly allocated either to FR or to enhanced medical care (EMC: treatment as usual plus two counseling interviews) as control intervention with 2 weekly sessions over the 5-week trial each. Thirty-nine (39) patients completed FR and 39 received EMC. An impairment-severity score (IS) was employed as the primary outcome parameter with assessment at baseline, after treatment, and again after 3-month follow-up. FR was significantly superior to EMC with a standardized effect size of 0.85. The achieved effects through FR remained stable in terms of psychic and bodily impairment after 3-month follow-up. The results of our trial suggest a positive effect of FR training on subjective functional impairment in the IS, if provided in addition to treatment as usual (TAU). There appears to be a clinically relevant long-term benefit of FR as a nonpharmacological and complementary therapy approach in IBS.

  9. Vision-Related Quality-of-Life Outcomes in the Mycotic Ulcer Treatment Trial I: A Randomized Clinical Trial.

    Science.gov (United States)

    Rose-Nussbaumer, Jennifer; Prajna, N Venkatesh; Krishnan, K Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; O'Brien, Kieran S; Ray, Kathryn J; McLeod, Stephen D; Porco, Travis C; Lietman, Thomas M; Acharya, Nisha R; Keenan, Jeremy D

    2015-06-01

    Given the limitations in health care resources, quality-of-life measures for interventions have gained importance. To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I, as measured by an Indian Vision Function Questionnaire. Secondary analysis (performed October 11-25, 2014) of a double-masked, multicenter, randomized, active comparator-controlled, clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture- or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of 20/40 to 20/400 (logMAR of 0.3-1.3). Study participants were randomly assigned to topical voriconazole, 1%, or topical natamycin, 5%. Subscale score on the Indian Vision Function Questionnaire from each of the 4 subscales (mobility, activity limitation, psychosocial impact, and visual function) at 3 months. A total of 323 patients were enrolled in the trial, and 292 (90.4%) completed the Indian Vision Function Questionnaire at 3 months. The majority of study participants had subscale scores consistent with excellent function. After adjusting for baseline visual acuity and organism, we found that study participants in the natamycin-treated group scored, on average, 4.3 points (95% CI, 0.1-8.5) higher than study participants in the voriconazole-treated group (P = .046). In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle-corrected visual acuity, the natamycin-treated group scored 8.4 points (95% CI, 1.9-14.9) higher than the voriconazole-treated group (P = .01). Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism (1.5 points [95% CI, -3.9 to 6.9]; P = .52). We found evidence of improvement in vision-related quality of life among patients with fungal ulcers

  10. Effect of Adjunctive Raloxifene Therapy on Severity of Refractory Schizophrenia in Women: A Randomized Clinical Trial.

    Science.gov (United States)

    Kulkarni, Jayashri; Gavrilidis, Emorfia; Gwini, Stella M; Worsley, Roisin; Grigg, Jasmin; Warren, Annabelle; Gurvich, Caroline; Gilbert, Heather; Berk, Michael; Davis, Susan R

    2016-09-01

    A substantial proportion of women with schizophrenia experience debilitating treatment-refractory symptoms. The efficacy of estrogen in modulating brain function in schizophrenia has to be balanced against excess exposure of peripheral tissue. Raloxifene hydrochloride is a selective estrogen receptor modulator (mixed estrogen agonist/antagonist) with potential psychoprotective effects and fewer estrogenic adverse effects. To determine whether adjunctive raloxifene therapy reduces illness severity in women with refractory schizophrenia. This 12-week, double-blind, placebo-controlled, randomized clinical trial with fortnightly assessments was performed at an urban tertiary referral center and a regional center from January 1, 2006, to December 31, 2014. Participants included 56 women with schizophrenia or schizoaffective disorder and marked symptom severity despite substantial and stable antipsychotic doses. Data were analyzed using intention to treat as the basis. Adjunctive raloxifene hydrochloride, 120 mg/d, or placebo for 12 weeks. The primary outcome was the change in the Positive and Negative Syndrome Scale (PANSS) total score. Clinical response (defined as a ≥20% decrease in PANSS total score from baseline) and change in PANSS subscale scores, mood, cognition, reproductive hormone levels, and adverse events were also assessed. Of the 56 participants (mean [SD] age, 53 [7.7] years; age range, 40-70 years; mean [SD] duration of psychotic illness, 24 [11] years), 26 were randomized to raloxifene and 30 were randomized to placebo. Raloxifene produced a greater reduction in the PANSS total score relative to placebo (β = -6.37; 95% CI, -11.64 to -1.10; P = .02) and resulted in an increased probability of a clinical response (hazard ratio, 5.79; 95% CI, 1.46 to 22.97; P = .01). A significant reduction was found in the PANSS general symptom scores for the raloxifene compared with the placebo (β = -3.72; 95% CI, -6.83 to -0.61; P = .02) groups

  11. A randomized clinical trial on the sealing of occlusal carious lesions: 3–4-year results

    Directory of Open Access Journals (Sweden)

    Luana Severo ALVES

    2017-06-01

    Full Text Available Abstract This randomized clinical trial aimed to assess the efficacy of sealing occlusal carious lesions in permanent teeth. The sample consisted of 54 occlusal carious lesions in permanent molars and premolars of 49 patients aged 8–43 years (median: 19 years. The inclusion criteria comprised the presence of a cavity with no access allowing biofilm control. The maximum depth of the lesion was the middle third of the dentin thickness, as assessed by bitewing radiography. The teeth were randomly assigned to sealant treatment (n = 28 or restorative treatment (n = 26. Clinical and radiographic examinations were performed after 1 year and after 3–4 years. The outcomes depended on the clinical performance of the sealant/restoration and the control of caries progression observed radiographically. Survival analysis was performed to assess success rates. Over the 3-4 years of monitoring, 2 sealants were totally lost, 1 needed repair, and 1 showed caries progression, totaling 4 failures in the sealant group. In the restoration group, 1 failure was observed (in need of repair. The success rates were 76% and 94% in the sealant and the restoration groups, respectively (p > 0.05. The sealing of occlusal carious lesions in permanent teeth succeeded in controlling caries over a 3–4-year period. However, sealed carious lesions require patient compliance in attending regular follow-ups to control the occurrence of clinical failures of the sealants.

  12. Comparison between biodentine and formocresol for pulpotomy of primary teeth: A randomized clinical trial.

    Science.gov (United States)

    El Meligy, Omar Abd El Sadek; Allazzam, Sulaiman; Alamoudi, Najlaa Mohd

    2016-01-01

    To assess and compare the clinical and radiographic success rates of biodentine and formocresol for pulpotomy in human primary teeth. A randomized, split-mouth, double-blind, controlled clinical trial was carried out in 37 healthy 4- to 8-year-old children with 56 pairs (112 teeth) of contralateral primary molars indicated for pulpotomy. Matched teeth in each pair were randomized to undergo either biodentine (n = 56 teeth) or formocresol (n = 56 teeth) pulpotomy. In both groups, the teeth were restored with stainless steel crowns. The teeth were evaluated clinically and radiographically at 3 and 6 months by two blinded, standardized, and calibrated examiners. The data were analyzed using chi-square and McNemar tests with a P value of biodentine (100%) and formocresol (100%), without any statistically significant difference (P = 1). Pulp canal obliteration was radiographically observed in 10/56 (17.9%) and 7/56 (12.5%) cases in the biodentine and formocresol groups, respectively. Both pulpotomy techniques showed favorable clinical and radiographic outcomes at 3 and 6 months posttreatment without any significant difference. Hence, biodentine has the potential to become a substitute for formocresol in primary molar pulpotomies.

  13. Treatment of localized gingival recessions using gingival unit grafts: a randomized controlled clinical trial.

    Science.gov (United States)

    Kuru, Bahar; Yıldırım, Selin

    2013-01-01

    One of the success factors in periodontal plastic surgery is the synergistic relationship between involved tissues and vascular supply. Gingiva as a functional unit is unique with a specific vascular configuration and contains the supracrestal portion naturally created to survive over avascular root surfaces. The aim of this randomized controlled trial is to clinically evaluate the treatment of localized gingival recessions by using gingival unit grafts (palatal tissue involving marginal gingiva and papillae) compared with conventional palatal grafts. Seventeen patients with Class I to II recession defects on mandibular anterior teeth were included and randomly divided into two groups. Recessions were treated with gingival unit grafts in group 1 (n = 8) and with palatal grafts in group 2 (n = 9). Clinical parameters including vertical recession (VR), probing depth, keratinized tissue (KT), and attachment level were recorded at baseline and 8 months after surgery. Both treatments produced significant clinical improvements within the groups. Intergroup comparison revealed significantly higher VR reduction, attachment, and KT gain in group 1 than in group 2; mean percentages of the defect coverage were 91.62% ± 9.74% and 68.97% ± 13.67%, respectively (P <0.05). Healing of the gingival unit donor site was uneventful. Within its limits, this study demonstrates the possibility of treating buccal recessions with gingival unit grafts as an alternative technique using gingival donor graft of site-specific vascular configuration, with better defect coverage, clinical, and esthetic improvements compared with palatal grafts.

  14. Impact of clinical pharmacist-based parenteral nutrition service for bone marrow transplantation patients: a randomized clinical trial.

    Science.gov (United States)

    Mousavi, Maryam; Hayatshahi, Alireza; Sarayani, Amir; Hadjibabaie, Molouk; Javadi, Mohammadreza; Torkamandi, Hassan; Gholami, Kheirollah; Ghavamzadeh, Ardeshir

    2013-12-01

    Parenteral nutrition (PN) is a well-documented supportive care which maintains the nutritional status of patients. Clinical pharmacists are often involved in providing PN services; however, few studies have investigated the effect of a clinical pharmacy-based PN service in resource-limited settings. We designed a randomized clinical trial to compare the clinical pharmacist-based PN service (intervention group) with the conventional method (control group) for adult patients undergoing hematopoietic stem cell transplantation in Shariati Hospital, Tehran, Iran (2011-2012). In the intervention group, the clinical pharmacists implemented standard guidelines of nutrition support. The conventional method was a routine nutrition support protocol which was pursued for all patients in the bone marrow transplantation wards. Main study outcomes included nutritional status (weight, albumin, total protein, pre-albumin, and nitrogen balance), length of hospital stay, time to engraftment, rate of graft versus host disease, and mortality rate. Patients were followed for 3 months. Fifty-nine patients were randomly allocated to a study group. The overall intake (oral and parenteral) in the control group was significantly lower than standard daily needed calories (P nutritional outcomes were either preserved or improved in the intervention group while the nutritional status in the control group was deteriorated (P values hospital stay was significantly shorter in the intervention group (P nutrition support service significantly improved nutritional status and clinical outcomes in comparison with the suboptimal conventional method. Future studies should assess the cost effectiveness of clinical pharmacists' PN services.

  15. Effect of Educational Package on Lifestyle of Primiparous Mothers during Postpartum Period: A Randomized Controlled Clinical Trial

    Science.gov (United States)

    Khodabandeh, Farzaneh; Mirghafourvand, Mojgan; KamaliFard, Mahin; Mohammad-Alizadeh-Charandabi, Sakineh; Asghari Jafarabadi, Mohammad

    2017-01-01

    A healthy lifestyle is important for mothers during the postpartum period. This study was conducted to determine the effects of a lifestyle educational package in primiparous women. This randomized clinical trial was conducted on 220 mothers assigned to two groups using block randomization. In the intervention group, the mothers received…

  16. Marital Status and Satisfaction Five Years Following a Randomized Clinical Trial Comparing Traditional versus Integrative Behavioral Couple Therapy

    Science.gov (United States)

    Christensen, Andrew; Atkins, David C.; Baucom, Brian; Yi, Jean

    2010-01-01

    Objective: To follow distressed married couples for 5 years after their participation in a randomized clinical trial. Method: A total of 134 chronically and seriously distressed married couples were randomly assigned to approximately 8 months of either traditional behavioral couple therapy (TBCT; Jacobson & Margolin, 1979) or integrative…

  17. Randomized Controlled Trial in Clinical Settings to Evaluate Effectiveness of Coping Skills Education Used with Progressive Tinnitus Management

    Science.gov (United States)

    Henry, James A.; Thielman, Emily J.; Zaugg, Tara L.; Kaelin, Christine; Schmidt, Caroline J.; Griest, Susan; McMillan, Garnett P.; Myers, Paula; Rivera, Izel; Baldwin, Robert; Carlson, Kathleen

    2017-01-01

    Purpose: This randomized controlled trial evaluated, within clinical settings, the effectiveness of coping skills education that is provided with progressive tinnitus management (PTM). Method: At 2 Veterans Affairs medical centers, N = 300 veterans were randomized to either PTM intervention or 6-month wait-list control. The PTM intervention…

  18. Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

    Science.gov (United States)

    Mohtadi, Nicholas; Barber, Rhamona; Chan, Denise; Paolucci, Elizabeth Oddone

    2016-05-01

    Complications/adverse events of anterior cruciate ligament (ACL) surgery are underreported, despite pooled level 1 data in systematic reviews. All adverse events/complications occurring within a 2-year postoperative period after primary ACL reconstruction, as part of a large randomized clinical trial (RCT), were identified and described. Prospective, double-blind randomized clinical trial. Patients and the independent trained examiner were blinded to treatment allocation. University-based orthopedic referral practice. Three hundred thirty patients (14-50 years; 183 males) with isolated ACL deficiency were intraoperatively randomized to ACL reconstruction with 1 autograft type. Graft harvest and arthroscopic portal incisions were identical. Patients were equally distributed to patellar tendon (PT), quadruple-stranded hamstring tendon (HT), and double-bundle (DB) hamstring autograft ACL reconstruction. Adverse events/complications were patient reported, documented, and diagnoses confirmed. Two major complications occurred: pulmonary embolism and septic arthritis. Twenty-four patients (7.3%) required repeat surgery, including 25 separate operations: PT = 7 (6.4%), HT = 9 (8.2%), and DB = 8 (7.3%). Repeat surgery was performed for meniscal tears (3.6%; n = 12), intra-articular scarring (2.7%; n = 9), chondral pathology (0.6%; n = 2), and wound dehiscence (0.3%; n = 1). Other complications included wound problems, sensory nerve damage, muscle tendon injury, tibial periostitis, and suspected meniscal tears and chondral lesions. Overall, more complications occurred in the HT/DB groups (PT = 24; HT = 31; DB = 45), but more PT patients complained of moderate or severe kneeling pain (PT = 17; HT = 9; DB = 4) at 2 years. Overall, ACL reconstructive surgery is safe. Major complications were uncommon. Secondary surgery was necessary 7.3% of the time for complications/adverse events (excluding graft reinjury or revisions) within the first 2 years. Level 1 (therapeutic studies

  19. A randomized trial of the clinical utility of genetic testing for obesity: design and implementation considerations.

    Science.gov (United States)

    Wang, Catharine; Gordon, Erynn S; Stack, Catharine B; Liu, Ching-Ti; Norkunas, Tricia; Wawak, Lisa; Christman, Michael F; Green, Robert C; Bowen, Deborah J

    2014-02-01

    Obesity rates in the United States have escalated in recent decades and present a major challenge in public health prevention efforts. Currently, testing to identify genetic risk for obesity is readily available through several direct-to-consumer companies. Despite the availability of this type of testing, there is a paucity of evidence as to whether providing people with personal genetic information on obesity risk will facilitate or impede desired behavioral responses. We describe the key issues in the design and implementation of a randomized controlled trial examining the clinical utility of providing genetic risk information for obesity. Participants are being recruited from the Coriell Personalized Medicine Collaborative, an ongoing, longitudinal research cohort study designed to determine the utility of personal genome information in health management and clinical decision making. The primary focus of the ancillary Obesity Risk Communication Study is to determine whether genetic risk information added value to traditional communication efforts for obesity, which are based on lifestyle risk factors. The trial employs a 2 × 2 factorial design in order to examine the effects of providing genetic risk information for obesity, alone or in combination with lifestyle risk information, on participants' psychological responses, behavioral intentions, health behaviors, and weight. The factorial design generated four experimental arms based on communication of estimated risk to participants: (1) no risk feedback (control), (2) genetic risk only, (3) lifestyle risk only, and (4) both genetic and lifestyle risk (combined). Key issues in study design pertained to the selection of algorithms to estimate lifestyle risk and determination of information to be provided to participants assigned to each experimental arm to achieve a balance between clinical standards and methodological rigor. Following the launch of the trial in September 2011, implementation challenges

  20. SMART trial: A randomized clinical trial of self-monitoring in behavioral weight management-design and baseline findings.

    Science.gov (United States)

    Burke, Lora E; Styn, Mindi A; Glanz, Karen; Ewing, Linda J; Elci, Okan U; Conroy, Margaret B; Sereika, Susan M; Acharya, Sushama D; Music, Edvin; Keating, Alison L; Sevick, Mary Ann

    2009-11-01

    The primary form of treatment for obesity today is behavioral therapy. Self-monitoring diet and physical activity plays an important role in interventions targeting behavior and weight change. The SMART weight loss trial examined the impact of replacing the standard paper record used for self-monitoring with a personal digital assistant (PDA). This paper describes the design, methods, intervention, and baseline sample characteristics of the SMART trial. The SMART trial used a 3-group design to determine the effects of different modes of self-monitoring on short- and long-term weight loss and on adherence to self-monitoring in a 24-month intervention. Participants were randomized to one of three conditions (1) use of a standard paper record (PR); (2) use of a PDA with dietary and physical activity software (PDA); or (3), use of a PDA with the same software plus a customized feedback program (PDA + FB). We screened 704 individuals and randomized 210. There were statistically but not clinically significant differences among the three cohorts in age, education, HDL cholesterol, blood glucose and systolic blood pressure. At 24 months, retention rate for the first of three cohorts was 90%. To the best of our knowledge, the SMART trial is the first large study to compare different methods of self-monitoring in a behavioral weight loss intervention and to compare the use of PDAs to conventional paper records. This study has the potential to reveal significant details about self-monitoring patterns and whether technology can improve adherence to this vital intervention component.

  1. Non-pharmacological care for patients with generalized osteoarthritis: design of a randomized clinical trial.

    Science.gov (United States)

    Hoogeboom, Thomas J; Stukstette, Mirelle J P M; de Bie, Rob A; Cornelissen, Jessica; den Broeder, Alfons A; van den Ende, Cornelia H M

    2010-07-01

    Non-pharmacological treatment (NPT) is a useful treatment option in the management of hip or knee osteoarthritis. To our knowledge however, no studies have investigated the effect of NPT in patients with generalized osteoarthritis (GOA). The primary aim of this study is to compare the effectiveness of two currently existing health care programs with different intensity and mode of delivery on daily functioning in patients with GOA. The secondary objective is to compare the cost-effectiveness of both interventions. In this randomized, single blind, clinical trial with active controls, we aim to include 170 patients with GOA. The experimental intervention consist of six self-management group sessions provided by a multi-disciplinary team (occupational therapist, physiotherapist, dietician and specialized nurse). The active control group consists of two group sessions and four sessions by telephone, provided by a specialized nurse and physiotherapist. Both therapies last six weeks. Main study outcome is daily functioning during the first year after the treatment, assessed on the Health Assessment Questionnaire. Secondary outcomes are health related quality of life, specific complaints, fatigue, and costs. Illness cognitions, global perceived effect and self-efficacy, will also be assessed for a responder analysis. Outcome assessments are performed directly after the intervention, after 26 weeks and after 52 weeks. This article describes the design of a randomized, single blind, clinical trial with a one year follow up to compare the costs and effectiveness of two non-pharmacological interventions with different modes of delivery for patients with GOA. Dutch Trial Register NTR2137.

  2. Why Prospectively Randomized Clinical Trials Have Been Rare in Reproductive Medicine and Will Remain So?

    Science.gov (United States)

    Gleicher, Norbert; Kushnir, Vitaly A; Barad, David H

    2016-01-01

    There is almost unanimity that modern medicine should be "evidence based." In this context, lack of prospectively randomized clinical trials (RCTs) is widely lamented in reproductive medicine. Some leading voices, indeed, increasingly suggest that only RCT-based clinical conclusions should be integrated into clinical practice, since lower levels of evidence are inadequate. We have argued that reproductive medicine requires special considerations because, like clinical oncology, fertility treatments (especially in older women) are time dependent. Unlike clinical oncology, reproductive medicine, however, does not receive substantial financial research support from government or industry and, at least in the United States, has, therefore, to be primarily funded via patient revenues. Given a 50% chance of receiving placebo, infertility patients are, understandably, reluctant to fund their own RCTs. We here selectively review this subject, contrasting opposing opinions recently published in the literature by a prominent reproductive scientist and one of the world's leading experts on evidence-based medicine. Placing these recent publications into the evolving context of infertility practice, as also addressed in this journal in recent publications, we conclude that objective reasons explain why relatively few RCTs are performed in reproductive medicine and predict that this will not change in the foreseeable future. Reproductive medicine, therefore, has to find ways to develop satisfactory clinical evidence in other ways, satisfying patients' rights to easy access to potentially beneficial medical treatments with low costs and low risks. The RCTs should be reserved for relatively high risk and/or high cost treatments. © The Author(s) 2015.

  3. Exogenous melatonin for sleep disorders in neurodegenerative diseases: a meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Zhang, Wei; Chen, Xue-yan; Su, Su-wen; Jia, Qing-zhong; Ding, Tao; Zhu, Zhong-ning; Zhang, Tong

    2016-01-01

    The purpose of this work is to investigate the efficacy of exogenous melatonin in the treatment of sleep disorders in patients with neurodegenerative disease. We searched Pubmed, the Cochrane Library, and ClinicalTrials.gov, from inception to July 2015. We included randomized clinical trials (RCTs) that compared melatonin with placebo and that had the primary aim of improving sleep in people with neurodegenerative diseases, particularly Alzheimer's disease (AD) and Parkinson's disease (PD). We pooled data with the weighted mean difference in sleep outcomes. To assess heterogeneity in results of individual studies, we used Cochran's Q statistic and the I (2) statistic. 9 RCTs were included in this research. We found that the treatment with exogenous melatonin has positive effects on sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) in PD patients (MD: 4.20, 95 % CI: 0.92-7.48; P = 0.01), and by changes in PSQI component 4 in AD patients (MD: 0.67, 95 % CI: 0.04-1.30; P = 0.04), but not on objective sleep outcomes in both AD and PD patients. Treatment with melatonin effectively improved the clinical and neurophysiological aspects of rapid eye movement (REM) sleep behavior disorder (RBD), especially elderly individuals with underlying neurodegenerative disorders. This meta-analysis provided some evidence that melatonin improves sleep quality in patients with AD and PD, and melatonin can be considered as a possible sole or add-on therapy in neurodegenerative disorders patients with RBD.

  4. Randomized clinical trial of Appendicitis Inflammatory Response score-based management of patients with suspected appendicitis.

    Science.gov (United States)

    Andersson, M; Kolodziej, B; Andersson, R E

    2017-10-01

    The role of imaging in the diagnosis of appendicitis is controversial. This prospective interventional study and nested randomized trial analysed the impact of implementing a risk stratification algorithm based on the Appendicitis Inflammatory Response (AIR) score, and compared routine imaging with selective imaging after clinical reassessment. Patients presenting with suspicion of appendicitis between September 2009 and January 2012 from age 10 years were included at 21 emergency surgical centres and from age 5 years at three university paediatric centres. Registration of clinical characteristics, treatments and outcomes started during the baseline period. The AIR score-based algorithm was implemented during the intervention period. Intermediate-risk patients were randomized to routine imaging or selective imaging after clinical reassessment. The baseline period included 1152 patients, and the intervention period 2639, of whom 1068 intermediate-risk patients were randomized. In low-risk patients, use of the AIR score-based algorithm resulted in less imaging (19·2 versus 34·5 per cent; P appendicitis (6·8 versus 9·7 per cent; P = 0·034). Intermediate-risk patients randomized to the imaging and observation groups had the same proportion of negative appendicectomies (6·4 versus 6·7 per cent respectively; P = 0·884), number of admissions, number of perforations and length of hospital stay, but routine imaging was associated with an increased proportion of patients treated for appendicitis (53·4 versus 46·3 per cent; P = 0·020). AIR score-based risk classification can safely reduce the use of diagnostic imaging and hospital admissions in patients with suspicion of appendicitis. Registration number: NCT00971438 ( http://www.clinicaltrials.gov). © 2017 BJS Society Ltd Published by John Wiley & Sons Ltd.

  5. A transdisciplinary model to inform randomized clinical trial methods for electronic cigarette evaluation

    Directory of Open Access Journals (Sweden)

    Alexa A. Lopez

    2016-03-01

    Full Text Available Abstract Background This study is a systematic evaluation of a novel tobacco product, electronic cigarettes (ECIGs using a two-site, four-arm, 6-month, parallel-group randomized controlled trial (RCT with a follow-up to 9 months. Virginia Commonwealth University is the primary site and Penn State University is the secondary site. This RCT design is important because it is informed by analytical work, clinical laboratory results, and qualitative/quantitative findings regarding the specific ECIG products used. Methods Participants (N = 520 will be randomized across sites and must be healthy smokers of >9 cigarettes for at least one year, who have not had a quit attempt in the prior month, are not planning to quit in the next 6 months, and are interested in reducing cigarette intake. Participants will be randomized into one of four 24-week conditions: a cigarette substitute that does not produce an inhalable aerosol; or one of three ECIG conditions that differ by nicotine concentration 0, 8, or 36 mg/ml. Blocked randomization will be accomplished with a 1:1:1:1 ratio of condition assignments at each site. Specific aims are to: characterize ECIG influence on toxicants, biomarkers, health indicators, and disease risk; determine tobacco abstinence symptom and adverse event profile associated with real-world ECIG use; and examine the influence of ECIG use on conventional tobacco product use. Liquid nicotine concentration-related differences on these study outcomes are predicted. Participants and research staff in contact with participants will be blinded to the nicotine concentration in the ECIG conditions. Discussion Results from this study will inform knowledge concerning ECIG use as well as demonstrate a model that may be applied to other novel tobacco products. The model of using prior empirical testing of ECIG devices should be considered in other RCT evaluations. Trial registration TRN: NCT02342795 , registered December 16, 2014.

  6. The reporting of adverse events following spinal manipulation in randomized clinical trials-a systematic review.

    Science.gov (United States)

    Gorrell, Lindsay M; Engel, Roger M; Brown, Benjamin; Lystad, Reidar P

    2016-09-01

    Spinal manipulative therapy (SMT) is commonly used to treat spinal disorders. Although clinical practice guidelines recommend the use of SMT in the treatment of neck and back disorders, concerns exist about the nature and incidence of adverse events associated with the intervention. Comprehensive reporting of adverse events in clinical trials could allow for accurate incidence estimates through meta-analysis. However, it is not clear if randomized clinical trials (RCTs) that involve SMT are currently reporting adverse events adequately. This study aimed to describe the extent of adverse events reporting in published RCTs involving SMT, and to determine whether the quality of reporting has improved since publication of the 2010 Consolidated Standards Of Reporting Trials (CONSORT) statement. This is a systematic literature review. The Physiotherapy Evidence Database (PEDro) and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched for RCTs involving SMT. Domains of interest included classifications of adverse events, completeness of adverse events reporting, nomenclature used to describe the events, methodological quality of the study, and details of the publishing journal. Data were analyzed using descriptive statistics. Frequencies and proportions of trials reporting on each of the specified domains above were calculated. Differences in proportions between pre- and post-CONSORT trials were calculated with 95% confidence intervals using standard methods, and statistical comparisons were analyzed using tests for equality of proportions with continuity correction. There was no funding obtained for this study. The authors declare no conflict of interest. Of 7,398 records identified in the electronic searches, 368 articles were eligible for inclusion in this review. Adverse events were reported in 140 (38.0%) articles. There was a significant increase in the reporting of adverse events post-CONSORT (p=.001). There were two major adverse events

  7. Glass ionomer ART sealant and fluoride-releasing resin sealant in fissure caries prevention--results from a randomized clinical trial

    National Research Council Canada - National Science Library

    Liu, Bao Ying; Xiao, Yue; Chu, Chun Hung; Lo, Edward Chin Man

    2014-01-01

    The relative performance of ART sealant and fluoride-releasing resin sealant in preventing fissure caries in permanent molars was compared in a randomized clinical trial conducted in southern China (ClinicalTrials.gov NCT01829334...

  8. Lorcaserin for Smoking Cessation and Associated Weight Gain: A Randomized 12-Week Clinical Trial.

    Science.gov (United States)

    Shanahan, William R; Rose, Jed E; Glicklich, Alan; Stubbe, Scott; Sanchez-Kam, Matilde

    2017-08-01

    Lorcaserin is a selective serotonin 2C receptor agonist approved by the Food and Drug Administration for chronic weight management. Preclinical data suggest that it may also be effective in smoking cessation through modulation of the dopaminergic reward system. This was a 12-week, randomized, double-blind, placebo-controlled trial conducted in 30 centers in the United States. Six hundred three adult smokers with a Body Mass Index of 18.5-35 kg/m2, averaging at least 10 cigarettes/day with no period of abstinence >3 months for the past year were randomized to lorcaserin 10 mg once daily (QD), 10 mg twice daily (BID) or placebo; all received standardized smoking cessation counseling weekly. The target quit date was day 15. The primary endpoint was the exhaled carbon monoxide confirmed Continuous Abstinence Rate for weeks 9-12 (month 3). Continuous Abstinence Rates for month 3 were 5.6%, 8.7%, and 15.3% for the placebo, QD and BID groups, respectively (BID vs. placebo odds ratio 3.02, 95% confidence interval 1.47, 6.22, p = .0027. Change in weight at week 12 (randomized population) was -0.01, -0.35 and -0.98 kg, respectively (p = .0004, BID vs. placebo), and +0.73, +0.76, and -0.41 kg in participants achieving month 3 continuous abstinence. The most frequent adverse events were headache, nausea, constipation, and fatigue. Lorcaserin with counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain over a 3-month period. Further investigation of lorcaserin in smoking cessation is warranted. Trial Registration: ClinicalTrials.gov. Identifier: NCT02044874. This randomized, controlled trial demonstrated that lorcaserin used in conjunction with standard cessation counseling was associated with dose-related increases in smoking cessation and prevention of associated weight gain. To our knowledge, this is the first demonstration in humans of a potential role of 5-HT2C agonism in the modulation of central neurological

  9. The efficacy of a plasma arc light in orthodontic bonding: a randomized controlled clinical trial.

    Science.gov (United States)

    Russell, Joanne S; Littlewood, Simon J; Blance, Andrew; Mitchell, Laura

    2008-09-01

    To evaluate the clinical performance of a plasma arc light (Ortho LITE, 3M Unitek, Monrovia, CA, USA) against a conventional tungsten-quartz halogen curing light (Visilux 2, 3M Unitek, Monrovia, CA, USA) for direct orthodontic bonding. A single centre prospective randomized controlled clinical trial. The Orthodontic Department at St Luke's Hospital, Bradford, UK. Forty-three consecutive patients requiring fixed appliances from the orthodontic waiting list. A split mouth technique was adopted; with quadrants randomly assigned to either the plasma arc light or the conventional halogen curing light and bonded directly with APC pre-adjusted edgewise brackets (3M Unitek, Monrovia, CA, USA). Bracket failures. Time taken to bond-up the appliances, patient sensitivity or discomfort during curing and time to replace failed brackets were investigated. No statistically significant difference in bracket failure rates over the full course of treatment was found between the plasma arc light (6.7%; 95% CI 4.5-10.0) and the halogen curing light (9.5%; 95% CI 6.8-13.1). There was no statistically significant difference in bracket survival times. The bond-up times were typically reduced by 204 seconds per patient with the plasma arc light. There were no differences in patient reported sensitivity or discomfort or rebond times. The plasma arc light is a viable clinical alternative to the conventional halogen curing light with benefits for both the clinician and patient due to reduced bonding times.

  10. Brief relaxation versus music distraction in the treatment of dental anxiety: a randomized controlled clinical trial.

    Science.gov (United States)

    Lahmann, Claas; Schoen, Rainer; Henningsen, Peter; Ronel, Joram; Muehlbacher, Moritz; Loew, Thomas; Tritt, Karin; Nickel, Marius; Doering, Stephan

    2008-03-01

    Dental anxiety is a significant cause of poor dental health. Because patients often prefer nonpharmacological interventions, the clinical effectiveness of clearly structured approaches is of particular interest. This prospective randomized controlled study compares a brief relaxation method (BR) with music distraction (MD) and with a control group (C). The authors randomly assigned 90 patients with dental anxiety to BR, MD or C groups. They assessed the outcomes by means of the state anxiety subscale of the State-Trait Anxiety Inventory. Both BR and MD reduced dental anxiety significantly. In contrast, patients in the C group did not exhibit a significant change in their anxiety level. BR was significantly superior to MD. Stratification according to the patient's general level of dental anxiety revealed that BR also was particularly effective in highly anxious subjects, whereas MD did not have a clinically relevant effect on these subjects. BR appears to be a safe, economically sound and effective nonpharmacological approach to the short-term reduction of dental anxiety. Additional investigations are needed to validate these findings in a larger clinical trial and to determine the long-term effects of this intervention. Relaxation techniques are a pragmatic, effective and cost-saving method of facilitating dental treatment in anxious patients.

  11. A pilot randomized controlled trial of smoking cessation in an outpatient respirology clinic

    Science.gov (United States)

    Pakhale, Smita; Baron, Justine; Armstrong, Michael A; Garde, Avanti; Reid, Robert D; Alvarez, Gonzalo; Aitken, Debbie; Mullen, Kerri-Anne; Wells, George; Pipe, Andrew

    2015-01-01

    OBJECTIVE: To assess the feasibility and potential effectiveness of a modified version of the Ottawa Model for Smoking Cessation in an outpatient respirology clinic. METHODS: Adult tobacco smokers attending the respirology clinic and willing to choose a quit date within one month of enrollment were randomly assigned to receive standard care or the intervention. Standard care participants received smoking cessation advice, a brochure and a prescription for smoking cessation medication if requested. Intervention participants received a $110 voucher to purchase smoking cessation pharmacotherapy and were registered to an automated calling system. Answers to automated calls determined which participants required nurse telephone counselling. Feasibility indicators included recruitment and retention rates, and intervention adherence. The effectiveness indicator was self-reported smoking status at 26 to 52 weeks. RESULTS: Forty-nine (54.4%) of 90 eligible smokers were randomly assigned to the intervention (n=23) or control (n=26) group. Self-reported smoking status at 26 to 52 weeks was available for 32 (65.3%) participants. The quit rate for intervention participants was 18.2% compared with 7.7% for controls (OR2.36 [95% CI 0.39 to 14.15]). CONCLUSION: It would be feasible to evaluate this intervention in a larger trial. Alternatives to face-to-face follow-up at the clinic are recommended. PMID:25647168

  12. Influence of statistician involvement on reporting of randomized clinical trials in medical oncology.

    Science.gov (United States)

    Péron, Julien; You, Benoit; Gan, Hui K; Maillet, Denis; Chen, Eric X; Pond, Gregory R

    2013-03-01

    Ideally, statisticians should be involved in the design, analysis, and reporting of randomized clinical trials (RCTs). This study assessed the impact of a statistician involvement in published medical oncology RCTs between 2005 and 2009. The reporting quality of each publication was rated using the Overall Reporting Quality Score on the basis of either 2001 or 2010 Consolidated Standards of Reporting Trials criteria. A four-question email survey on the statistical design and analysis was sent to the corresponding authors of each trial. Nonresponders were approached a maximum of three times. Overall, 107 responses were received from 357 solicited authors (30%). Corresponding authors from industry-funded RCTs were less likely to respond (51 vs. 65%, P=0.013). The same person was responsible for statistical design and analyses in 47% of cases. Overall, the statistician involved held a PhD (or equivalent) in statistics in most cases. The statisticians responsible for the statistical design and analysis were listed as coauthors in 68 and 81% of RCT manuscripts. There was no statistically significant impact on manuscript reporting quality of the degree of statistician involvement in manuscript preparation. Fewer trials were reported as positive when the responsible statistician was listed as a coauthor. It is possible that RCTs included in this review are in general of higher quality or were more likely to have a greater level of statistician involvement than smaller, single-arm, or unpublished studies. This imbalance could explain the lack of significant difference observed in the Overall Reporting Quality Score between trials where statisticians were listed as coauthors or not.

  13. Modified Atkins diet in adult with refractory epilepsy: A controlled randomized clinical trial.

    Science.gov (United States)

    Zare, Mohammad; Okhovat, Ali Asghar; Esmaillzadeh, Ahmad; Mehvari, Jafar; Najafi, Mohammad Reza; Saadatnia, Mohammad

    2017-04-04

    Background: The usefulness of the modified Atkins diet (mAD) in refractory epilepsy in adults has been rarely investigated. We aimed to evaluate the efficacy of mAD in adult with refractory epilepsy. Methods: In a controlled randomized clinical trial, we enrolled 66 refractory adult epileptic cases from February 2010 to December 2012. The patients were randomly divided into two groups, case groups (22 patients) used antiepileptic drugs and mAD and control group (32 patients) only use antiepileptic drugs. The primary outcome was at least 50% decrement in seizure frequency after 2 months of therapy. Results: No significant difference was shown in our data between groups regarding baseline characteristic. The differences of mean seizure attack after 2 months (P 50% seizure decrease at 1 and after 2 months and 12 (35.3%) had 50% decrease in seizure frequency. Furthermore, in mAD group, the mean urinary ketone positivity was 1.75 ± 0.28 and increasing liver enzyme was shown 5 cases (14.7%) in mAD group and 5 cases (15.6%) in control group (P < 0.050). Conclusion: The mAD may be effective as a cotherapy treatment for adults with refractory epilepsy and decrease 2.19 times seizure frequency in comparison with control groups. Trials with the more tolerant dietary regime, with larger sample size and longer duration, should be performed in future.

  14. TVT versus laparoscopic mesh colposuspension: 5-year follow-up results of a randomized clinical trial.

    Science.gov (United States)

    Valpas, A; Ala-Nissilä, S; Tomas, E; Nilsson, C G

    2015-01-01

    Before the introduction of the tension-free vaginal tape (TVT) procedure for the treatment of female stress urinary incontinence, the colposuspension operation was regarded as the "gold standard" procedure. The laparoscopic variant of the colposuspension was introduced as a less invasive operation. The aim of the present trial was to compare the new minimally invasive TVT procedure with laparoscopic mesh colposuspension (LCM). A multicenter randomized clinical trial conducted in six public hospitals in Finland including primary cases of stress incontinence. Objective treatment success criteria were a negative stress test and no retreatment for stress incontinence. Patient satisfaction was assessed by Patients Global Impression of Improvement, a visual analog scale, and the Urinary Incontinence Severity Score. Of 128 randomized patients, 121 underwent the allocated operation. At the 5-year follow-up 77 % in the TVT group and 84 % in the LCM group could be assessed according to the protocol. The objective cure rate was significantly higher in the TVT group (94 %) than in the LCM group (78 %). Subjective treatment satisfaction (completely satisfied with the procedure) was significantly higher in the TVT group (64 %) than in the LCM group (51 %). By per protocol analysis both objective and subjective cure rates were significantly higher in the TVT group than in the LCM group. If cases that were lost to follow-up were regarded as failures, the intension-to-treat analysis found no difference between the groups.

  15. Family Presence during Resuscitation: A Qualitative Analysis from a National Multicenter Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Carla De Stefano

    Full Text Available The themes of qualitative assessments that characterize the experience of family members offered the choice of observing cardiopulmonary resuscitation (CPR of a loved one have not been formally identified.In the context of a multicenter randomized clinical trial offering family members the choice of observing CPR of a patient with sudden cardiac arrest, a qualitative analysis, with a sequential explanatory design, was conducted. The aim of the study was to understand family members' experience during CPR. All participants were interviewed by phone at home three months after cardiac arrest. Saturation was reached after analysis of 30 interviews of a randomly selected sample of 75 family members included in the trial. Four themes were identified: 1- choosing to be actively involved in the resuscitation; 2- communication between the relative and the emergency care team; 3- perception of the reality of the death, promoting acceptance of the loss; 4- experience and reactions of the relatives who did or did not witness the CPR, describing their feelings. Twelve sub-themes further defining these four themes were identified. Transferability of our findings should take into account the country-specific medical system.Family presence can help to ameliorate the pain of the death, through the feeling of having helped to support the patient during the passage from life to death and of having participated in this important moment. Our results showed the central role of communication between the family and the emergency care team in facilitating the acceptance of the reality of death.

  16. Back pain: a randomized clinical trial of rotational manipulation of the trunk

    Science.gov (United States)

    Glover, J. R.; Morris, Jean G.; Khosla, T.

    1974-01-01

    Glover, J. R., Morris, Jean G., and Khosla, T. (1974).British Journal of Industrial Medicine,31, 59-64. Back pain: a randomized clinical trial of rotational manipulation of the trunk. A therapeutic trial was conducted in a medium-sized engineering works on patients suffering from back pain with its accompanying tenderness and hyperaesthesia. The patients were randomly allocated to two treatment groups, (a) manipulation, and (b) de-tuned (i.e., simulated) short-wave diathermy, the latter acting as a placebo. The manipulated group were given one lumbar rotational manipulation session of 15 minutes or less and this was followed by four daily detuned short-wave diathermy sessions of 15 minutes. The control group were given five 15-minute daily sessions of detuned short-wave diathermy only. The patients' own subjective assessment of relief from pain was recorded in the range 0% (no relief) to 100% (complete relief). The responses were measured at three stages, (1) within 15 minutes, (2) three days after treatment, and (3) seven days after treatment. Although each of the two treatment groups showed progressive and marked improvement in the percentage of relief from pain during the seven-day period, there was no demonstrable difference between the two, except that at the 15-minute stage the relief from pain in the manipulated group was always greater than in the controls. PMID:4274488

  17. Erythromycin for Gastric Emptying in Patients Undergoing General Anesthesia for Emergency Surgery: A Randomized Clinical Trial.

    Science.gov (United States)

    Czarnetzki, Christoph; Elia, Nadia; Frossard, Jean-Louis; Giostra, Emiliano; Spahr, Laurent; Waeber, Jean-Luc; Pavlovic, Gordana; Lysakowski, Christopher; Tramèr, Martin R

    2015-08-01

    Patients undergoing emergency procedures under general anesthesia have impaired gastric emptying and are at high risk for aspiration of gastric contents. Erythromycin has strong gastric prokinetic properties. To evaluate the efficacy of erythromycin lactobionate in gastric emptying in patients undergoing emergency surgery. The Erythro-Emerge trial was a single-center, randomized, double-blinded, placebo-controlled clinical trial in patients undergoing emergency surgery under general anesthesia at Geneva University Hospitals. We included 132 patients from March 25, 2009, through April 10, 2013, and all patients completed the study. Randomization was stratified for trauma and nontrauma procedures. The randomization code was opened on April 23, 2013, and analyses were performed through July 26, 2013. We performed an intention-to-treat analysis. Patients were randomized to intravenous erythromycin lactobionate, 3 mg/kg, or placebo 15 minutes before tracheal intubation. Patients were followed up for 24 hours. The primary outcome was a clear stomach, defined as less than 40 mL of liquids and no solids and identified through endoscopy immediately after intubation. The secondary outcome was the pH level of residual gastric content. A clear stomach was diagnosed in 42 of 66 patients (64%) receiving placebo compared with 53 of 66 patients (80%) receiving erythromycin (risk ratio, 1.26 [95% CI, 1.01-1.57]). In the population undergoing surgery for nontrauma, the association between receipt of erythromycin and having a clear stomach (adjusted odds ratio [95% CI]) was statistically significant (13.4 [1.49-120]; P = .02); in the population undergoing surgery for trauma, it was not (1.81 [0.64-5.16]; P = .26). Median (interquartile range) pH of the residual gastric liquid was 2 (1-4) in 36 patients receiving placebo and 6 (3-7) in 16 receiving erythromycin (P = .002). Patients receiving erythromycin had nausea (20 [30%] vs 4 [6%]) and stomach cramps (15 [23%] vs 2 [3

  18. Comparison of Efficacy and Safety Between Propranolol and Steroid for Infantile Hemangioma: A Randomized Clinical Trial.

    Science.gov (United States)

    Kim, Kyu Han; Choi, Tae Hyun; Choi, Yunhee; Park, Young Woon; Hong, Ki Yong; Kim, Dong Young; Choe, Yun Seon; Lee, Hyunjung; Cheon, Jung-Eun; Park, Jung-Bin; Park, Kyung Duk; Kang, Hyoung Jin; Shin, Hee Young; Jeong, Jae Hoon

    2017-06-01

    There are limited data from randomized clinical trials comparing propranolol and steroid medication for treatment of infantile hemangioma (IH). To determine the efficacy and safety of propranolol compared with steroid as a first-line treatment for IH. This randomized clinical noninferiority trial tested the efficacy and safety of propranolol vs steroid treatment for IH at a single academic hospital. All participants were diagnosed with IH between June 2013 and October 2014, had normal heart function, and had not been previously treated for IH. The participants were randomly assigned to either the propranolol group or the steroid group. In the propranolol group, the patients were admitted, observed for adverse effects for 3 days after treatment initiation, and then released and treated as outpatients for 16 weeks (2 mg/kg/d). In the steroid group, the patients were seen as outpatients from the beginning and were also treated for 16 weeks (2 mg/kg/d). The primary efficacy variable was the response to treatment at 16 weeks, which was evaluated by the hemangioma volume using magnetic resonance imaging before and at 16 weeks after treatment initiation. While comparing the effect of medication between the groups, we monitored the adverse effects of both drugs. A total of 34 patients (15 boys, 19 girls; mean age, 3.3 months; range, 0.3-8.2 months) were randomized to receive either propranolol or steroid treatment (17 in each treatment group). Guardians for 2 patients in the steroid group withdrew their consent, and 1 patient in the propranolol group did not complete the efficacy test. The intention-to-treat analysis, applying multiple imputations, found the treatment response rate in the propranolol group to be 95.65%, and that of the steroid group was 91.94%. Because the difference in response rate between the groups was 3.71%, propranolol was considered noninferior. We found that there was no difference between the groups in safety outcomes. Our trial demonstrated that

  19. Metaphor use and health literacy: a pilot study of strategies to explain randomization in cancer clinical trials.

    Science.gov (United States)

    Krieger, Janice L; Parrott, Roxanne L; Nussbaum, Jon F

    2011-01-01

    Patients often have difficulty understanding what randomization is and why it is needed in Phase III clinical trials. Physicians commonly report using metaphorical language to convey the role of chance in being assignment to treatment; however, the effectiveness of this strategy as an educational tool has not been explored. Guided by W. McGuire's (1972) information-processing model, the purpose of this pilot study was to explore effects of metaphors to explain randomization on message acceptance and behavioral intention to participate in a Phase III clinical trial among a sample of low-income, rural women (N = 64). Participants were randomly assigned to watch a video that explained randomization using 1 of 3 message strategies: a low-literacy definition, standard metaphor (i.e., flip of a coin), or a culturally derived metaphor (i.e., sex of a baby). The influence of attention on behavioral intentions to participate in clinical trials was partially moderated by message strategy. Under conditions of low attention, participants in the culturally derived metaphor condition experienced significantly higher intentions to participate in clinical trials compared with participants in the standard metaphor condition. However, as attention increased, differences in intentions among the conditions diminished. Having a positive affective response to the randomization message was a strong, positive predictor of behavioral intentions to participate in clinical trials. The authors discuss the theoretical and practical implications of these findings.

  20. Predicting nursing home adherence to a clinical trial intervention: lessons for the conduct of cluster randomized trials.

    Science.gov (United States)

    Tjia, Jennifer; Mazor, Kathleen M; Field, Terry; Doherty, Peter; Spenard, Ann; Gurwitz, Jerry H

    2011-12-01

    To describe factors predictive of nursing home (NH) adherence to a clinical trial intervention. Post hoc analysis of a cluster randomized trial (CRT) evaluating a structured communication intervention to improve nurse-physician telephone communication in NHs. NH. All eligible licensed nursing staff in all participating NHs. Adherence was defined as active participation for at least 3 months of the 12-month trial. NH characteristics hypothesized to affect trial outcomes (profit status, bed size, nursing staff time, NH quality, and leadership turnover) were measured a priori. The association between intervention adherence, NH characteristics and preintervention questionnaire response rate was examined. Of 13 intervention NHs, seven adhered to the intervention. Three factors differentiated adherent from nonadherent NHs: director of nursing turnover (nonadherent NHs 50% vs adherent NHs 0%, P = .03); Centers for Medicare and Medicaid Services (CMS) nurse staffing rating (range: 1-5) (nonadherent NHs mean 3.7 ± 0.5 vs adherent NHs mean 4.3 ± 0.5), P = .048); and questionnaire response rate (nonadherent NHs 15.6 ± 10.0% vs adherent NHs 34.2 ± 12.1%, P = .02). Profit status, bed size, and number of NH deficiencies on state surveys were not significantly associated with intervention adherence. CMS nurse staffing rating, leadership turnover, and questionnaire response rate are associated with adherence to a CRT intervention. Pretrial evaluation of NH staffing rating by CMS and of response to a questionnaire can help investigators improve trial efficiency by screening for NHs likely to adhere to a CRT intervention. © 2011, Copyright the Authors Journal compilation © 2011, The American Geriatrics Society.

  1. Is pancreaticogastrostomy safer than pancreaticojejunostomy after pancreaticoduodenectomy? A meta-regression analysis of randomized clinical trials.

    Science.gov (United States)

    Ricci, Claudio; Casadei, Riccardo; Taffurelli, Giovanni; Pacilio, Carlo Alberto; Beltrami, Denis; Minni, Francesco

    To evaluate the clinically relevant POPF rate between Pancreatogastrostomy (PG) and pancreaticojejunostomy (PJ) after pancreaticoduodenectomy (PD). To evaluate the confounding factors affecting meta-analytic results. A systematic literature search of randomized clinical trials (RCTs) comparing PG to PJ with an International Study Group of Pancreatic Fistula (ISGPF) definition of postoperative pancreatic fistula (POPF). Risk difference (RD) and number needed to treat or harm (NNT and NNH) were used. Fixed and random-effect models were applied. Impact of confounding covariates on the meta-analytic results was evaluated using meta-regression analysis, reporting β coefficient ± standard error (SE). Seven RCTs were identified involving 1184 patients: 603 PG and 581 PJ. RD in the fixed model of clinically relevant POPFs suggested that PG was superior to PJ (RD-0.07; 95% CI: -0.11 to -0.03) with an NNT of 14 (95% CI: 9 to 33). In random model, PG was not superior to PJ (RD-0.06; 95% CI: -0.13 to 0.01) with an NNT of 17 and a possibility of harm in some cases (NNH = 100). Meta-regression suggested that the increase in the proportion of "soft pancreas" in the PG arm corresponded to a more positive value of RD (β = 0.47 ± 0.19; P value: 0.045 ± 0.003). A PG could be slightly superior to PJ in the prevention of clinically relevant POPF. The presence of high risk pancreatic remnant remains the main limitation of PG. Copyright © 2017. Published by Elsevier B.V.

  2. Wireless Versus Wired Iontophoresis for Treating Patellar Tendinopathy: A Randomized Clinical Trial.

    Science.gov (United States)

    Rigby, Justin H; Mortensen, Brett B; Draper, David O

    2015-11-01

    The efficacy of the relatively new wireless iontophoresis patch compared with the traditional wired dose controller is unknown. To determine the differences among 2 iontophoresis drug-delivery systems (wireless patch versus wired dose controller) and a sham treatment in treating patellar tendinopathy. Randomized controlled clinical trial. Physical therapy clinic. Thirty-one participants diagnosed with patellar tendinopathy (men = 22, women = 9, age = 24.5 ± 5.9 years). Participants were randomly assigned into 1 of 3 treatment groups: wireless patch, wired dose controller, or sham treatment. Participants in the active treatment groups received six 80 mA/min iontophoresis treatments using 2 mL of 4% dexamethasone sodium phosphate. During each visit, clinical outcome measures were assessed and then the assigned treatment was applied. Clinical outcome measures were Kujala Anterior Knee Pain Scale, pressure sensitivity, knee-extension force, and sit-to-stand pain assessment using a numeric rating scale. For each clinical outcome measure, we used a repeated-measures analysis of covariance to determine differences among the treatment groups over the treatment period. Participants reported a clinically important improvement on the Kujala Anterior Knee Pain Scale across all treatment groups, with no differences among groups (P = .571). A placebo effect was observed with pressure sensitivity (P = .0152); however, the active treatment decreased participants' pain during the sit-to-stand test (P = .042). A placebo effect occurred with the sham treatment group. Generally, improvement was noted in all groups regardless of treatment type, but greater pain reduction during a functional task was evident within the active treatment groups during the sit-to-stand test. The wireless patch and wired dose controller treatments were equivalent across all variables.

  3. Nebulized hypertonic saline for bronchiolitis in the emergency department: a randomized clinical trial.

    Science.gov (United States)

    Florin, Todd A; Shaw, Kathy N; Kittick, Marlena; Yakscoe, Stephen; Zorc, Joseph J

    2014-07-01

    Acute bronchiolitis is the most frequent lower respiratory tract infection in infants, yet there are no effective therapies available. Current evidence is unclear about the role of hypertonic saline (HS) for the acute treatment of bronchiolitis. To determine whether nebulized 3% HS compared with normal saline (NS) improves respiratory distress in infants with bronchiolitis not responding to standard treatments in the emergency department. A randomized clinical trial with blinding of investigators, health care providers, and parents was conducted at a single urban pediatric ED. The participants included children aged 2 to less than 24 months with their first episode of bronchiolitis and a Respiratory Distress Assessment Instrument score of 4 to 15 after nasal suctioning and a trial of nebulized albuterol. Patients were randomized to receive either nebulized 3% HS (HS group) or NS (NS group). The primary outcome was change in respiratory distress at 1 hour after the intervention, as measured by the Respiratory Assessment Change Score (a decrease indicates improvement). Secondary outcomes included vital signs, oxygen saturation, hospitalization, physician clinical impression, parental assessment, and adverse events. The 31 patients enrolled in each treatment arm had similar baseline demographic and clinical characteristics. At 1 hour after the intervention, the HS group demonstrated significantly less improvement in the median Respiratory Assessment Change Score compared with the NS group (HS, -1 [interquartile range, -5 to 1] vs. NS, -5 [interquartile range, -6 to -2]; P = .01). There were no significant differences in heart rate, oxygen saturation, hospitalization rate, or other outcomes. There were no adverse events. Infants with bronchiolitis and persistent respiratory distress after standard treatment in the emergency department had less improvement after receiving 3% HS compared with those who received NS. Based on these results and the existing evidence

  4. Effectiveness of papain gel in venous ulcer treatment: randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ana Luiza Soares Rodrigues

    2015-06-01

    Full Text Available OBJECTIVE: to assess the effectiveness of 2% papain gel compared to 2% carboxymethyl cellulose in the treatment of chronic venous ulcer patients.METHOD: randomized controlled clinical trial with 12-week follow-up. The sample consisted of 18 volunteers and 28 venous ulcers. In the trial group, 2% papain gel was used and, in the control group, 2% carboxymethyl cellulose gel.RESULTS: the trial group showed a significant reduction in the lesion area, especially between the fifth and twelfth week of treatment, with two healed ulcers and a considerable increase in the amount of epithelial tissue in the wound bed.CONCLUSION: 2% papain gel demonstrated greater effectiveness in the reduction of the lesion area, but was similar to 2% carboxymethyl cellulose gel regarding the reduction in the amount of exudate and devitalized tissue. Multicenter research is suggested to evidence the effectiveness of 2% papain gel in the healing of venous ulcers. UTN number: U1111-1157-2998

  5. The effectiveness and efficacy of Rhodiola rosea L.: a systematic review of randomized clinical trials.

    Science.gov (United States)

    Hung, Shao Kang; Perry, Rachel; Ernst, Edzard

    2011-02-15

    To critically assess the current evidence from randomized clinical trials (RCTs) for or against the effectiveness or efficacy of Rhodiola rosea. Systematic literature searches were performed in six electronic databases: AMED (1985-July 2009), CINAHL (1982-July 2009), The Cochrane Library (search in July 2009), EMBASE (1974-July 2009), MEDLINE (1950-July 2009) and Web of Science (searched in July 2009). No language restrictions were imposed. Reference lists of all retrieved articles were searched, and experts and manufacturers were contacted for unpublished RCT. RCTs testing the efficacy or effectiveness of mono-preparations of R. rosea as sole treatment administered orally against a control intervention in any human individual suffering from any condition or healthy human volunteers were included. Studies were selected, data extracted, and quality assessed by two independent reviewers. Eleven RCTs met the inclusion criteria; all were placebo-controlled. Six trials investigated the effects of R. rosea on physical performance, four on mental performance, and two in patients diagnosed with mental health condition. The methodological quality of most trials was moderate or good. Only few mild adverse events were reported. R. rosea may have beneficial effects on physical performance, mental performance, and certain mental health conditions. There is, however, a lack of independent replications of the single different studies. Five of the 10 RCTs reached more than three points on the Jadad score (i.e., good quality). More research seems warranted. Copyright © 2010 Elsevier GmbH. All rights reserved.

  6. Selecting the appropriate pacing mode for patients with sick sinus syndrome: evidence from randomized clinical trials.

    Science.gov (United States)

    Albertsen, A E; Nielsen, J C

    2003-12-01

    Several observational studies have indicated that selection of pacing mode may be important for the clinical outcome in patients with symptomatic bradycardia, affecting the development of atrial fibrillation (AF), thromboembolism, congestive heart failure, mortality and quality of life. In this paper we present and discuss the most recent data from six randomized trials on mode selection in patients with sick sinus syndrome (SSS). In pacing mode selection, VVI(R) pacing is the least attractive solution, increasing the incidence of AF and-as compared with AAI(R) pacing, also the incidence of heart failure, thromboembolism and death. VVI(R) pacing should not be used as the primary pacing mode in patients with SSS, who haven't chronic AF. AAIR pacing is superior to DDDR pacing, reducing AF and preserving left ventricular function. Single site right ventricular pacing-VVI(R) or DDD(R) mode-causes an abnormal ventricular activation and contraction (called ventricular desynchronization), which results in a reduced left ventricular function. Despite the risk of AV block, we consider AAIR pacing to be the optimal pacing mode for isolated SSS today and an algorithm to select patients for AAIR pacing is suggested. Trials on new pacemaker algorithms minimizing right ventricular pacing as well as trials testing alternative pacing sites and multisite pacing to reduce ventricular desynchronization can be expected within the next years.

  7. Bayesian adaptive randomization in a clinical trial to identify new regimens for MDR-TB: the endTB trial.

    Science.gov (United States)

    Cellamare, M; Milstein, M; Ventz, S; Baudin, E; Trippa, L; Mitnick, C D

    2016-12-01

    Evidence-based optimization of treatment for multidrug-resistant tuberculosis (MDR-TB), including integration of new drugs, is urgent. Such optimization would benefit from efficient trial designs requiring fewer patients. Implementation of such innovative designs could accelerate improvements in and access to MDR-TB treatment. To describe the application, advantages, and challenges of Bayesian adaptive randomization in a Phase III non-inferiority trial of MDR-TB treatment. endTB is the first Phase III non-inferiority trial of MDR-TB treatment to use Bayesian adaptive randomization. We present a simulation study with assumptions for treatment response at 8, 39, and 73 weeks after randomization, on which sample size calculations are based. We show differences between Bayesian adaptive randomization and balanced randomization designs in sample size and number of patients exposed to ineffective regimens. With 750 participants, 27% fewer than required by balanced randomization, the study had 80% power to detect up to two (of five) novel treatment regimens that are non-inferior (margin 12%) to the control (70% estimated efficacy) at 73 weeks post randomization. Comparing Bayesian adaptive randomization to balanced randomization, up to 25% more participants would receive non-inferior regimens. Bayesian adaptive randomization may expose fewer participants to ineffective treatments and enhance the efficiency of MDR-TB treatment trials.

  8. Partnering around cancer clinical trials (PACCT): study protocol for a randomized trial of a patient and physician communication intervention to increase minority accrual to prostate cancer clinical trials.

    Science.gov (United States)

    Eggly, Susan; Hamel, Lauren M; Heath, Elisabeth; Manning, Mark A; Albrecht, Terrance L; Barton, Ellen; Wojda, Mark; Foster, Tanina; Carducci, Michael; Lansey, Dina; Wang, Ting; Abdallah, Rehab; Abrahamian, Narineh; Kim, Seongho; Senft, Nicole; Penner, Louis A

    2017-12-02

    Cancer clinical trials are essential for testing new treatments and represent state-of-the-art cancer treatment, but only a small percentage of patients ever enroll in a trial. Under-enrollment is an even greater problem among minorities, particularly African Americans, representing a racial/ethnic disparity in cancer care. One understudied cause is patient-physician communication, which is often of poor quality during clinical interactions between African-American patients and non-African-American physicians. Partnering Around Cancer Clinical Trials (PACCT) involves a transdisciplinary theoretical model proposing that patient and physician individual attitudes and beliefs and their interpersonal communication during racially discordant clinical interactions influence outcomes related to patients' decisions to participate in a trial. The overall goal of the study is to test a multilevel intervention designed to increase rates at which African-American and White men with prostate cancer make an informed decision to participate in a clinical trial. Data collection will occur at two NCI-designated comprehensive cancer centers. Participants include physicians who treat men with prostate cancer and their African-American and White patients who are potentially eligible for a clinical trial. The study uses two distinct research designs to evaluate the effects of two behavioral interventions, one focused on patients and the other on physicians. The primary goal is to increase the number of patients who decide to enroll in a trial; secondary goals include increasing rates of physician trial offers, improving the quality of patient-physician communication during video recorded clinical interactions in which trials may be discussed, improving patients' understanding of trials offered, and increasing the number of patients who actually enroll. Aims are to 1) determine the independent and combined effects of the two interventions on outcomes; 2) compare the effects of the

  9. Eugenia uniflora Dentifrice for Treating Gingivitis in Children: Antibacterial Assay and Randomized Clinical Trial.

    Science.gov (United States)

    Jovito, Vanessa de Carvalho; Freires, Irlan Almeida; Ferreira, Danilo Augusto de Holanda; Paulo, Marçal de Queiroz; Castro, Ricardo Dias de

    2016-01-01

    School-age children are frequently at high risk for the onset of biofilm-dependent conditions, including dental caries and periodontal diseases. The objective of this study was to evaluate the clinical efficacy of a dentifrice containing Eugenia uniflora Linn. (Surinam cherry) extract versus a triclosan-based comparator in treating gingivitis in children aged 10-12 years. The in vitro antibacterial potential of the dentifrice was tested against oral pathogens (Streptococcus mutans, Streptococcus oralis and Lactobacillus casei). Then a phase-II clinical trial was conducted with 50 subjects aged 10-12 years, with clinical signs of gingivitis. The subjects were randomly assigned to the experimental group (n=25) and control group (n=25), in which participants used the experimental dentifrice and a triclosan-based fluoridated dentifrice (Colgate Total 12(r)), respectively. Clinical examinations assessed the presence of gingivitis (primary outcome) and biofilm accumulation (secondary outcome) using the Gingival-Bleeding Index (GBI) and Simplified Oral Hygiene Index (OHI-S), respectively, at baseline and after seven days of tooth brushing 3x/day. The data were analyzed using paired and unpaired t-test (GBI) and Wilcoxon and Mann-Whitney (OHI-S), with p≤0.05. The experimental dentifrice showed efficient antibacterial activity in vitro. In the clinical trial, a significant reduction in gingival bleeding was observed in both experimental and control groups (puniflora dentifrice showed anti-gingivitis properties in children aged 10-12 years. Thus, it may be a potentially efficient and safe product to be used alternatively in preventive dental practice.

  10. Late thrombotic events after bioresorbable scaffold implantation: a systematic review andmeta-analysis of randomized clinical trials

    NARCIS (Netherlands)

    Collet, Carlos; Asano, Taku; Miyazaki, Yosuke; Tenekecioglu, Erhan; Katagiri, Yuki; Sotomi, Yohei; Cavalcante, Rafael; de Winter, Robbert J.; Kimura, Takeshi; Gao, Runlin; Puricel, Serban; Cook, Stéphane; Capodanno, Davide; Onuma, Yoshinobu; Serruys, Patrick W.

    2017-01-01

    Aims To compare the long-term safety and efficacy of bioresorbable vascular scaffold (BVS) with everolimus-eluting stent (EES) after percutaneous coronary interventions. Methods and results A systematic review and meta-analysis of randomized clinical trials comparing clinical outcomes of patients

  11. Systemic corticosteroid monotherapy for clinically diagnosed acute rhinosinusitis: a randomized controlled trial

    NARCIS (Netherlands)

    Venekamp, R.P.; Bonten, M.J.; Rovers, M.M.; Verheij, T.J.; Sachs, A.P.

    2012-01-01

    BACKGROUND: Patients with acute rhinosinusitis are frequently encountered in primary care. Although corticosteroids are being increasingly used for symptom control, evidence supporting their use is inconclusive. We conducted a randomized controlled trial to examine the effectiveness of systemic

  12. Music and 25% glucose pain relief for the premature infant: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Maria Vera Lúcia Moreira Leitão Cardoso

    2014-10-01

    Full Text Available OBJECTIVE: to analyze the total Premature Infant Pain Profile scores of premature infants undergoing arterial puncture during music and 25% glucose interventions, and to assess their association with neonatal and therapeutic variables.METHOD: a randomized clinical trial with 80 premature infants; 24 in the Experimental Group 1 (music, 33 in the Experimental Group 2 (music and 25% glucose, 23 in the Positive Control Group (25% glucose. All premature infants were videotaped and a lullaby was played for ten minutes before puncture in Experimental Groups 1 and 2; 25% glucose administered in Experimental Group 2 and the Positive Control Group two minutes before puncture.RESULTS: 60.0% of premature infants had moderate or maximum pain; pain scores and intervention groups were not statistically significant. Statistically significant variables: Experimental Group 1: head and chest circumference, Apgar scores, corrected gestational age; Experimental Group 2: chest circumference, Apgar scores, oxygen therapy; Positive Control group: birth weight, head circumference.CONCLUSION: neonatal variables are associated with pain in premature infants. Brazilian Registry of Clinical Trials: UTN: U1111-1123-4821.

  13. Music and 25% glucose pain relief for the premature infant: a randomized clinical trial.

    Science.gov (United States)

    Cardoso, Maria Vera Lúcia Moreira Leitão; Farias, Leiliane Martins; de Melo, Gleicia Martins

    2014-10-01

    To analyze the total Premature Infant Pain Profile scores of premature infants undergoing arterial puncture during music and 25% glucose interventions, and to assess their association with neonatal and therapeutic variables. A randomized clinical trial with 80 premature infants; 24 in the Experimental Group 1 (music), 33 in the Experimental Group 2 (music and 25% glucose), 23 in the Positive Control Group (25% glucose). All premature infants were videotaped and a lullaby was played for ten minutes before puncture in Experimental Groups 1 and 2; 25% glucose administered in Experimental Group 2 and the Positive Control Group two minutes before puncture. 60.0% of premature infants had moderate or maximum pain; pain scores and intervention groups were not statistically significant. Statistically significant variables: Experimental Group 1: head and chest circumference, Apgar scores, corrected gestational age; Experimental Group 2: chest circumference, Apgar scores, oxygen therapy; Positive Control group: birth weight, head circumference. Neonatal variables are associated with pain in premature infants. Brazilian Registry of Clinical Trials: UTN: U1111-1123-4821.

  14. Improving function in age-related macular degeneration: design and methods of a randomized clinical trial.

    Science.gov (United States)

    Rovner, Barry W; Casten, Robin J; Hegel, Mark T; Massof, Robert W; Leiby, Benjamin E; Tasman, William S

    2011-03-01

    Age-Related Macular Degeneration (AMD) is the leading cause of severe vision loss in older adults and impairs the ability to read, drive, and live independently and increases the risk for depression, falls, and earlier mortality. Although new medical treatments have improved AMD's prognosis, vision-related disability remains a major public health problem. Improving Function in AMD (IF-AMD) is a two-group randomized, parallel design, controlled clinical trial that compares the efficacy of Problem-Solving Therapy (PST) with Supportive Therapy (ST) (an attention control treatment) to improve vision function in 240 patients with AMD. PST and ST therapists deliver 6 one-hour respective treatment sessions to subjects in their homes over 2 months. Outcomes are assessed masked to treatment assignment at 3 months (main trial endpoint) and 6 months (maintenance effects). The primary outcome is targeted vision function (TVF), which refers to specific vision-dependent functional goals that subjects highly value but find difficult to achieve. TVF is an innovative outcome measure in that it is targeted and tailored to individual subjects yet is measured in a standardized way. This paper describes the research methods, theoretical and clinical aspects of the study treatments, and the measures used to evaluate functional and psychiatric outcomes in this population. Copyright © 2010 Elsevier Inc. All rights reserved.

  15. Treatment comparison in randomized clinical trials with nonignorable missingness: A reverse regression approach.

    Science.gov (United States)

    Zhang, Zhiwei; Cheon, Kyeongmi

    2017-04-01

    A common problem in randomized clinical trials is nonignorable missingness, namely that the clinical outcome(s) of interest can be missing in a way that is not fully explained by the observed quantities. This happens when the continued participation of patients depends on the current outcome after adjusting for the observed history. Standard methods for handling nonignorable missingness typically require specification of the response mechanism, which can be difficult in practice. This article proposes a reverse regression approach that does not require a model for the response mechanism. Instead, the proposed approach relies on the assumption that missingness is independent of treatment assignment upon conditioning on the relevant outcome(s). This conditional independence assumption is motivated by the observation that, when patients are effectively masked to the assigned treatment, their decision to either stay in the trial or drop out cannot depend on the assigned treatment directly. Under this assumption, one can estimate parameters in the reverse regression model, test for the presence of a treatment effect, and in some cases estimate the outcome distributions. The methodology can be extended to longitudinal outcomes under natural conditions. The proposed approach is illustrated with real data from a cardiovascular study.

  16. Bandit solutions provide unified ethical models for randomized clinical trials and comparative effectiveness research.

    Science.gov (United States)

    Press, William H

    2009-12-29

    As electronic medical records enable increasingly ambitious studies of treatment outcomes, ethical issues previously important only to limited clinical trials become relevant to unlimited whole populations. For randomized clinical trials, adaptive assignment strategies are known to expose substantially fewer patients to avoidable treatment failures than strategies with fixed assignments (e.g., equal sample sizes). An idealized adaptive case--the two-armed Bernoulli bandit problem--can be exactly optimized for a variety of ethically motivated cost functions that embody principles of duty-to-patient, but the solutions have been thought computationally infeasible when the numbers of patients in the study (the "horizon") is large. We report numerical experiments that yield a heuristic approximation that applies even to very large horizons, and we propose a near-optimal strategy that remains valid even when the horizon is unknown or unbounded, thus applicable to comparative effectiveness studies on large populations or to standard-of-care recommendations. For the case in which the economic cost of treatment is a parameter, we give a heuristic, near-optimal strategy for determining the superior treatment (whether more or less costly) while minimizing resources wasted on any inferior, more expensive, treatment. Key features of our heuristics can be generalized to more complicated protocols.

  17. Taping patients with clinical signs of subacromial impingement syndrome: the design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Knol Dirk L

    2011-08-01

    Full Text Available Abstract Background Shoulder problems are a common complaint of the musculoskeletal system. Physical therapists treat these patients with different modalities such as exercise, massage, and shoulder taping. Although different techniques have been described, the effectiveness of taping has not yet been established. The aim of this study is to assess the effectiveness and cost-effectiveness of usual physical therapy care in combination with a particular tape technique for subacromial impingement syndrome of the shoulder compared to usual physical therapy care without this tape technique in a primary healthcare setting. Methods and design An economic evaluation alongside a randomized controlled trial will be conducted. A sample of 140 patients between 18 and 65 years of age with a diagnosis of subacromial impingement syndrome (SAIS as assessed by physical therapists will be recruited. Eligible patients will be randomized to either the intervention group (usual care in combination with the particular tape technique or the control group (usual care without this tape technique. In both groups, usual care will consist of individualized physical therapy care. The primary outcomes will be shoulder-specific function (the Simple Shoulder Test and pain severity (11-point numerical rating scale. The economic evaluation will be performed using a societal perspective. All relevant costs will be registered using cost diaries. Utilities (Quality Adjusted Life Years will be measured using the EuroQol. The data will be collected at baseline, and 4, 12, and 26 weeks follow-up. Discussion This pragmatic study will provide information about the effectiveness and cost-effectiveness of taping in patients presenting with clinical signs of SAIS. Trial registration Trial registration number: NTR2575

  18. Improving motor control in walking: a randomized clinical trial in older adults with subclinical walking difficulty.

    Science.gov (United States)

    Brach, Jennifer S; Lowry, Kristin; Perera, Subashan; Hornyak, Victoria; Wert, David; Studenski, Stephanie A; VanSwearingen, Jessie M

    2015-03-01

    To test the proposed mechanism of action of a task-specific motor learning intervention by examining its effect on measures of the motor control of gait. Single-blinded randomized clinical trial. University research laboratory. Adults (N=40) aged ≥65 years with gait speed >1.0m/s and impaired motor skill (figure-of-8 walk time >8s). The 2 interventions included a task-oriented motor learning and a standard exercise program; both interventions included strength training. Both lasted 12 weeks, with twice-weekly, 1-hour, physical therapist-supervised sessions. Two measures of the motor control of gait, gait variability and smoothness of walking, were assessed pre- and postintervention by assessors masked to the treatment arm. Of 40 randomized subjects, 38 completed the trial (mean age ± SD, 77.1±6.0y). The motor learning group improved more than the standard group in double-support time variability (.13m/s vs .05m/s; adjusted difference [AD]=.006, P=.03). Smoothness of walking in the anteroposterior direction improved more in the motor learning than standard group for all conditions (usual: AD=.53, P=.05; narrow: AD=.56, P=.01; dual task: AD=.57, P=.04). Smoothness of walking in the vertical direction also improved more in the motor learning than standard group for the narrow-path (AD=.71, P=.01) and dual-task (AD=.89, P=.01) conditions. Among older adults with subclinical walking difficulty, there is initial evidence that task-oriented motor learning exercise results in gains in the motor control of walking, while standard exercise does not. Task-oriented motor learning exercise is a promising intervention for improving timing and coordination deficits related to mobility difficulties in older adults, and needs to be evaluated in a definitive larger trial. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  19. The Effects of Inhalation Aromatherapy on Anxiety in Patients With Myocardial Infarction: A Randomized Clinical Trial

    Science.gov (United States)

    Najafi, Zahra; Taghadosi, Mohsen; Sharifi, Khadijeh; Farrokhian, Alireza; Tagharrobi, Zahra

    2014-01-01

    Background: Anxiety is an important mental health problem in patients with cardiac disease. Anxiety reduces patients’ quality of life and increases the risk of different cardiac complications. Objectives: The aim of this study was to investigate the effects of inhalation aromatherapy on anxiety in patients with myocardial infarction. Patients and Methods: This was a randomized clinical trial conduced on 68 patients with myocardial infarction hospitalized in coronary care units of a large-scale teaching hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran in 2013. By using the block randomization technique, patients were randomly assigned to experimental (33 patients receiving inhalation aromatherapy with lavender aroma twice a day for two subsequent days) and control (35 patients receiving routine care of study setting including no aromatherapy) groups. At the beginning of study and twenty minutes after each aromatherapy session, anxiety state of patients was assessed using the Spielberger’s State Anxiety Inventory. Data was analyzed using SPSS v. 16.0. We used Chi-square, Fisher’s exact, independent-samples T-test and repeated measures analysis of variance to analyze the study data. Results: The study groups did not differ significantly regarding baseline anxiety mean and demographic characteristics. However, after the administration of aromatherapy, anxiety mean in the experimental group was significantly lower than the control group. Conclusions: Inhalation aromatherapy with lavender aroma can reduce anxiety in patients with myocardial infarction. Consequently, healthcare providers, particularly nurses, can use this strategy to improve postmyocardial infarction anxiety management. PMID:25389481

  20. Severe hypertension in pregnancy: hydralazine or labetalol. A randomized clinical trial.

    Science.gov (United States)

    Vigil-De Gracia, Paulino; Lasso, Martin; Ruiz, Esteban; Vega-Malek, Juan Carlos; de Mena, Flor Tem; López, Juan Carlos

    2006-01-01

    The objective was to compare the safety and efficacy of intravenous labetalol and intravenous hydralazine for acutely lowering blood pressure in pregnancy. Two hundred women with severe hypertension in pregnancy were randomized to receive hydralazine (5 mg as a slow bolus dose given intravenously, and repeated every 20 min up to a maximum of five doses) or labetalol (20-mg intravenous bolus dose followed by 40 mg if not effective within 20 min, followed by 80 mg every 20 min up to a maximum dose of 300 mg). The primary end point was successful lowering of blood pressure and maternal hypotension. Women were similar with respect to characteristics at randomization. No significant differences were observed for maternal hypotension or persistent severe hypertension; only two patients in the hydralazine group presented with hypotension. Palpitations (p=0.01) and maternal tachycardia (p=0.05) occurred significantly more often in patients treated with hydralazine. The main neonatal outcomes were very similar per group; however, hypotension and bradycardia were significantly more frequent in the labetalol group. There were two neonatal deaths per antihypertensive drug group. This randomized clinical trial shows that labetalol and hydralazine fulfill the criteria required for an antihypertensive drug to treat severe hypertension in pregnancy.

  1. An Integrated Clinic-Community Partnership for Child Obesity Treatment: A Randomized Pilot Trial.

    Science.gov (United States)

    Hoffman, Jessica; Frerichs, Leah; Story, Mary; Jones, Jason; Gaskin, Kiah; Apple, Annie; Skinner, Asheley; Armstrong, Sarah

    2018-01-01

    Effective treatment of childhood obesity remains elusive. Integration of clinical and community systems may achieve effective and sustainable treatment. However, the feasibility and effectiveness of this integrated model are unknown. We conducted a randomized clinical trial among children aged 5 to 11 presenting for obesity treatment. We randomized participants to clinical care or clinical care plus community-based programming at a local parks and recreation facility. Primary outcomes were the change in child BMI at 6 months and the intensity of the program in treatment hours. Secondary outcomes included health behaviors, fitness, attrition, and quality of life. We enrolled 97 children with obesity, and retention at 6 months was 70%. Participants had a mean age of 9.1 years and a mean baseline BMI z score of 2.28, and 70% were living in poverty. Intervention participants achieved more treatment hours than controls (11.4 vs 4.4, SD: 15.3 and 1.6, respectively). We did not observe differences in child BMI z score or percent of the 95th percentile at 6 months. Intervention participants had significantly greater improvements in physical activity (P = .010) and quality of life (P = .008). An integrated clinic-community model of child obesity treatment is feasible to deliver in a low-income and racially diverse population. As compared with multidisciplinary treatment, the integrated model provides more treatment hours, improves physical activity, and increases quality of life. Parks and recreation departments hold significant promise as a partner agency to deliver child obesity treatment. Copyright © 2018 by the American Academy of Pediatrics.

  2. Intervention effects on negative affect of CPS-referred children: results of a randomized clinical trial.

    Science.gov (United States)

    Lind, Teresa; Bernard, Kristin; Ross, Emily; Dozier, Mary

    2014-09-01

    Exposure to early adversity places young children at risk for behavioral, physiological, and emotional dysregulation, predisposing them to a range of long-term problematic outcomes. Attachment and Biobehavioral Catch-up (ABC) is a 10-session intervention designed to enhance children's self-regulatory capabilities by helping parents to behave in nurturing, synchronous, and non-frightening ways. The effectiveness of the intervention was assessed in a randomized clinical trial, with parents who had been referred to Child Protective Services (CPS) for allegations of maltreatment. Parent-child dyads received either the ABC intervention or a control intervention. Following the intervention, children from the ABC intervention (n=56) expressed lower levels of negative affect during a challenging task compared to children from the control intervention (n=61). Copyright © 2014 Elsevier Ltd. All rights reserved.

  3. Randomized clinical trial of self-gripping mesh versus sutured mesh for Lichtenstein hernia repair

    DEFF Research Database (Denmark)

    Jorgensen, L N; Sommer, Thorbjørn; Assaadzadeh, S

    2013-01-01

    BACKGROUND: Many patients develop discomfort after open repair of a groin hernia. It was hypothesized that suture fixation of the mesh is a cause of these symptoms. METHODS: This patient- and assessor-blinded randomized multicentre clinical trial compared a self-gripping mesh (Parietene Progrip......(®) ) and sutured mesh for open primary repair of uncomplicated inguinal hernia by the Lichtenstein technique. Patients were assessed before surgery, on the day of operation, and at 1 and 12 months after surgery. The primary endpoint was moderate or severe symptoms after 12 months, including a combination...... of chronic pain, numbness and discomfort. RESULTS: The intention-to-treat population comprised 163 patients with self-gripping mesh and 171 with sutured mesh. The 12-month prevalence of moderate or severe symptoms was 17·4 and 20·2 per cent respectively (P = 0·573). There were no significant differences...

  4. Efficacy of dioctahedral smectite in acute watery diarrhea in Indian children: a randomized clinical trial.

    Science.gov (United States)

    Mujawar, Quais Mohammad; Naganoor, Ravi; Ali, Mir Dilshad; Malagi, Naushad; Thobbi, Achyut Narayan

    2012-02-01

    To determine the effects and safety of dioctahedral smectite (DS) on the duration of acute watery diarrhea in children. A Randomized, open labeled, clinical controlled trial in a tertiary care hospital outpatient department (OPD) and emergency department. Participants were one hundred and seventeen children without any chronic illness between 2 and 5 years presenting to OPD, having acute watery diarrhea for diarrhea in children aged 2-5 years. There were no adverse effects on the use of DS. DS was acceptable to the children, and its administration was not accompanied with any side effects. DS reduces the duration of diarrhea in Indian children and prevents a prolonged course, and therefore, may consistently reduce the costs in treatment of acute watery diarrhea.

  5. Patterns of Enrollment and Engagement of Custodial Grandmothers in a Randomized Clinical Trial of Psychoeducational Interventions

    Science.gov (United States)

    Smith, Gregory C.; Strieder, Frederick; Greenberg, Patty; Hayslip, Bert; Montoro-Rodriguez, Julian

    2016-01-01

    The authors used Andersen’s (2008) behavior model to investigate patterns of enrollment and treatment engagement among 343 custodial grandmothers who participated in a randomized clinical trial of three psychosocial interventions:(a) a behavioral parenting program, (b) a cognitive behavioral coping program, or (c) an information-only condition. Treatment completion was superior to that typically found with birth parents, even though the grandmothers and their target grandchildren both had high levels of mental and physical health challenges. Compliance did not differ significantly by condition but was higher among grandmothers who self-reported less positive affect, were older, and were using mental health professionals. Treatment satisfaction was highest in grandmothers who attended more treatment sessions, reported lower annual family income, had a health problem, and were using mental health professionals. The practice and policy implications of these findings are discussed, especially in terms of strategies for enhancing the engagement of custodial grandfamilies in future psychoeducational interventions. PMID:27667888

  6. Benzodiazepine loading versus symptom-triggered treatment of alcohol withdrawal: a prospective, randomized clinical trial.

    Science.gov (United States)

    Maldonado, José R; Nguyen, Long H; Schader, E Merritt; Brooks, John O

    2012-01-01

    The objectives were to compare the efficacy of a benzodiazepine loading versus a symptom-triggered protocol in the management of alcohol withdrawal. We conducted a prospective, randomized, controlled trial including 47 consecutive patients admitted to one of two tertiary care medical centers who developed alcohol withdrawal syndrome. Patients were randomly assigned to either a benzodiazepine loading protocol or a symptom-triggered treatment protocol. The Clinical Institute Withdrawal Assessment for Alcohol-Revised scale (CIWA-Ar) was recorded throughout the length of stay, along with measures of autonomic system functioning. The average rate of change of CIWA-Ar scores was -1.5 ± 1.3 for the symptom-triggered group and -2.3 ± 2.5 for the loading group. Average rate of change for systolic blood pressure was -2.7 ± 5.3 for the symptom-triggered group and -2.3 ± 6.4 for the loading group. There was no significant difference between the rates of change for either group on either measure. Similarly, there was no significant difference in total benzodiazepine use between groups. Within 72 h of treatment, 69.6% of patients in the loading group were free of withdrawal symptoms versus 41.7% in the symptom-triggered group, a difference not reaching statistical significance. This study did not reveal clear evidence of a clinical advantage for choosing either treatment method. Copyright © 2012 Elsevier Inc. All rights reserved.

  7. Effectiveness of dry needling for chronic nonspecific neck pain: a randomized, single-blinded, clinical trial.

    Science.gov (United States)

    Cerezo-Téllez, Ester; Torres-Lacomba, María; Fuentes-Gallardo, Isabel; Perez-Muñoz, Milagros; Mayoral-Del-Moral, Orlando; Lluch-Girbés, Enrique; Prieto-Valiente, Luis; Falla, Deborah

    2016-09-01

    Chronic neck pain attributed to a myofascial pain syndrome is characterized by the presence of muscle contractures referred to as myofascial trigger points. In this randomized, parallel-group, blinded, controlled clinical trial, we examined the effectiveness of deep dry needling (DDN) of myofascial trigger points in people with chronic nonspecific neck pain. The study was conducted at a public Primary Health Care Centre in Madrid, Spain, from January 2010 to December 2014. A total of 130 participants with nonspecific neck pain presenting with active myofascial trigger points in their cervical muscles were included. These participants were randomly allocated to receive: DDN plus stretching (n = 65) or stretching only (control group [n = 65]). Four sessions of treatment were applied over 2 weeks with a 6-month follow-up after treatment. Pain intensity, mechanical hyperalgesia, neck active range of motion, neck muscle strength, and perceived neck disability were measured at baseline, after 2 sessions of intervention, after the intervention period, and 15, 30, 90, and 180 days after the intervention. Significant and clinically relevant differences were found in favour of dry needling in all the outcomes (all P stretching is more effective than passive stretching alone in people with nonspecific neck pain. The results support the use of DDN in the management of myofascial pain syndrome in people with chronic nonspecific neck pain.

  8. Efficacy and safety of femtosecond laser-assisted corneal endothelial keratoplasty: a randomized multicenter clinical trial.

    Science.gov (United States)

    Cheng, Yanny Y Y; Schouten, Jan S A G; Tahzib, Nayyirih G; Wijdh, Robert-Jan; Pels, Elisabeth; van Cleynenbreugel, Hugo; Eggink, Catharina A; Rijneveld, Wilhelmina J; Nuijts, Rudy M M A

    2009-12-15

    To evaluate the efficacy and safety of femtosecond laser-assisted endothelial keratoplasty (FLEK) versus penetrating keratoplasty (PK) in patients with corneal endothelial disease. A randomized multicenter clinical trial of 80 eyes of 80 patients with corneal endothelial disease were randomized to FLEK or PK. Clinical outcomes (astigmatism and visual acuity) and incidence of postoperative complications were compared between the two groups. At 12 months, the percentage of eyes with a refractive astigmatism less than or equal to 3 diopters was higher in the FLEK group in comparison with the PK group (86.2% vs. 51.3%, P=0.004). The mean postoperative best corrected visual acuity was 20/70+/-2 lines in the FLEK group and 20/44+/-2 lines in the PK group (Pastigmatism and results in an absence of wound healing related problems in patients with endothelial disease. However, visual acuity is lower as compared with conventional PK, and the high level of endothelial cell loss warrants a modification of the insertion technique of the endothelial graft.

  9. The treatment of painful temporomandibular joint clicking with oral splints: a randomized clinical trial.

    Science.gov (United States)

    Conti, Paulo César Rodrigues; dos Santos, Carlos Neanes; Kogawa, Evelyn Mikaela; de Castro Ferreira Conti, Ana Claudia; de Araujo, Carlos dos Reis Pereira

    2006-08-01

    The authors compared the efficacy of bilateral balanced and canine guidance (occlusal) splints in the treatment of temporomandibular joint (TMJ) pain in subjects who experienced joint clicking with a nonoccluding splint in a double-blind, controlled randomized clinical trial. The authors randomly assigned 57 people with signs of disk displacement and TMJ pain into three groups according to the type of splint: bilateral balanced, canine guidance and nonoccluding. The authors followed the groups for six months using analysis of a visual analog scale (VAS), palpation of the TMJ and masticatory muscles, mandibular movements and joint sounds. They used repeated analysis of variance and a chi(2) test to test the hypothesis. The type of guidance used did not influence the pain reduction, yet both occlusal splints were superior to the nonoccluding splint, on the basis of the VAS. Despite similar outcomes in relation to opening, left lateral and protrusive movements, TMJ and muscle pain on palpation, subjects who used the occlusal splints had improved clinical outcomes. The frequency of joint noises decreased over time, with no significant differences among groups. Subjects in the groups using the occlusal splints reported more comfort. The type of lateral guidance did not influence the subjects' improvement. All of the subjects had a general improvement on the VAS, though subjects in the occlusal splint groups had better results that did subjects in the nonoccluding splint group.

  10. Midpalatal implants vs headgear for orthodontic anchorage--a randomized clinical trial: cephalometric results.

    Science.gov (United States)

    Benson, Philip E; Tinsley, David; O'Dwyer, Jonathan J; Majumdar, Arun; Doyle, Peter; Sandler, P Jonathan

    2007-11-01

    The purpose of this study was to compare the clinical effectiveness of the midpalatal implant as a method of reinforcing anchorage during orthodontic treatment with that of conventional extraoral anchorage. This was a prospective, randomized, clinical trial at Chesterfield and North Derbyshire Royal Hospital NHS Trust and the Charles Clifford Dental Hospital, Sheffield, in the United Kingdom. Fifty-one orthodontic patients between the ages of 12 and 39, with Class II Division 1 malocclusion and absolute anchorage requirements, were randomly allocated to receive either a midpalatal implant or headgear to reinforce orthodontic anchorage. The main outcome was to compare the mesial movement of the molars and the incisors of the 2 treatment groups between the start and the end of anchorage reinforcement as measured from cephalometric radiographs. The reproducibility of the measuring technique was acceptable. There were significant differences between T1 and T2 in the implant group for the positions of the maxillary central incisor (P mandibular molar (P mandibular central incisor (P mandibular molar (P skeletal and dental points moved mesially more in the headgear group during treatment than in the implant group. These ranged from an average of 0.5 mm more mesially for the mandibular permanent molar to 1.5 mm more mesially for the maxillary molar and the mandibular base. No treatment changes between the groups were statistically significant. Midpalatal implants are an acceptable technique for reinforcing anchorage in orthodontic patients.

  11. Randomized Clinical Trial of Intraosseous Methylprednisolone Injection for Acute Pulpitis Pain.

    Science.gov (United States)

    Bane, Khaly; Charpentier, Emmanuel; Bronnec, François; Descroix, Vianney; Gaye-N'diaye, Fatou; Kane, Abdoul Wahabe; Toledo, Rafael; Machtou, Pierre; Azérad, Jean

    2016-01-01

    The present study reports the results of a randomized clinical trial comparing local intraosseous methylprednisolone injection and emergency pulpotomy in the management of acute pulpitis on efficacy, safety, and efficiency end points. After providing prior informed written consent, 94 patients consulting for acute irreversible pulpitis pain at university-affiliated teaching hospital dental clinics in Dakar, Senegal were randomly assigned to either the methylprednisolone treatment group (n = 47) or the pulpotomy treatment group (n = 47). Patients were followed up at 1 week and assessed 6 months later to evaluate the therapeutic outcome of their treatment. At day 7 the patients in the methylprednisolone group reported less intense spontaneous and percussion pain in the day 0-day 7 period than the patients in the pulpotomy group. Methylprednisolone treatment took approximately 7 minutes (4.6-9.3) less to accomplish than pulpotomy (or about half the time). No difference in the therapeutic outcome was found between the 2 treatment groups at 6 months (all credible intervals span 0). This study establishes that methylprednisolone injection for acute pulpitis is relieved by a minimally invasive pharmacologic approach more effectively than by the reference pulpotomy and conserves scarce dental resources (ie, endodontic equipment and supplies, dental surgeon's time). Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  12. Enhancing physical function in HIV-infected older adults: A randomized controlled clinical trial.

    Science.gov (United States)

    Shah, Krupa N; Majeed, Zahraa; Yoruk, Yilmaz B; Yang, Hongmei; Hilton, Tiffany N; McMahon, James M; Hall, William J; Walck, Donna; Luque, Amneris E; Ryan, Richard M

    2016-06-01

    HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. In total, 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to 1 of 2 groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared with the control group (p autonomous motivation, depression, and QOL in HOA with functional limitations. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  13. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    Science.gov (United States)

    Gomes, Evelim L F D; Carvalho, Celso R F; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation. Clinicaltrials.gov NCT01438294.

  14. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Evelim L F D Gomes

    Full Text Available The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma.A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20 or a treadmill group (TG; n = 16. Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO, maximum exercise testing (Bruce protocol and lung function.No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05. Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG.The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation.Clinicaltrials.gov NCT01438294.

  15. Effects of music therapy on intravitreal injections: a randomized clinical trial.

    Science.gov (United States)

    Chen, Xuejing; Seth, Rajeev K; Rao, Veena S; Huang, John J; Adelman, Ron A

    2012-08-01

    To investigate the effects of music therapy on anxiety, perceived pain, and satisfaction in patients undergoing intravitreal injections in the outpatient setting. This is a randomized clinical trial. Seventy-three patients were recruited from the retina clinic at 1 institution and randomized into a music therapy (n=37) or control (n=36) group. Prior to injection, patients completed the state portion of the Spielberger State Trait Anxiety Inventory (STAI-S). The music therapy group listened to classical music through computer speakers while waiting for and during the injection. The control group underwent the injection in the same setting without music. Afterward, all patients completed another STAI-S and a satisfaction and pain questionnaire. The main outcome measures were objective anxiety derived from STAI-S scores and subjective pain and anxiety from the post procedure questionnaire. The music therapy group had a greater decrease in anxiety than the control group (P=0.0480). Overall, 73% of all patients requested music for future injections (P=0.0001). The music therapy group (84%) requested music in future injections more frequently than the control group (61%) (P=0.0377). Both groups reported similar levels of pain (P=0.5879). Classical music before and during intravitreal injections decreases anxiety in patients without decreasing pain. Most patients desire to have music during future injections. Music therapy is a low-cost, easy, safe intervention that reduces anxiety during intravitreal injections in the outpatient setting.

  16. Is Ceftizoxime an Appropriate Surrogate for Amikacin in Neonatal Sepsis Treatment? A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Peyman Salamati

    2011-08-01

    Full Text Available Neonatal sepsis, a life-threatening condition, presents with non-specific clinical manifestations and needs immediate empirical antimicrobial therapy. Choosing an appropriate antibiotic regimen covering the most probable pathogens is an important issue. In this study we compared the effectiveness of ceftizoxime and amikacin in the treatment of neonatal sepsis both in combination with ampicillin. In a randomized clinical trial, all term neonates with suspected sepsis referred to Bahrami hospital during March 2008 to March 2010 were evaluated. Patients were randomly recruited into two groups; one group receiving ampicillin and amikacin and the other ampicillin and ceftizoxime. Blood, urine and cerebrospinal fluid cultures, leukocyte count and C-reactive protein level were measured in all neonates. A total of 135 neonates were evaluated, 65 in amikacin group and 70 in ceftizoxime group. 60 neonates (85.7% in ceftizoxime group and 54 neonates (83.1% in amikacin group responded to the treatment (P= 0.673 and χ2 = 0.178. Only 24 (18% blood samples had a report of positive blood culture. The most frequent pathogen was coagulase negative staphylococcus with the frequency of 58.32% of all positive blood samples. Ceftizoxime in combination with ampicillin is an appropriate antimicrobial regimen for surrogating the combination of ampicillin and amikacin to prevent bacterial resistance against them.

  17. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial.

    Science.gov (United States)

    Zhao, Ling; Chen, Jiao; Li, Ying; Sun, Xin; Chang, Xiaorong; Zheng, Hui; Gong, Biao; Huang, Yinlan; Yang, Mingxiao; Wu, Xi; Li, Xuezhi; Liang, Fanrong

    2017-04-01

    The long-term prophylactic effects of acupuncture for migraine are uncertain. To investigate the long-term effects of true acupuncture compared with sham acupuncture and being placed in a waiting-list control group for migraine prophylaxis. This was a 24-week randomized clinical trial (4 weeks of treatment followed by 20 weeks of follow-up). Participants were randomly assigned to true acupuncture, sham acupuncture, or a waiting-list control group. The trial was conducted from October 2012 to September 2014 in outpatient settings at 3 clinical sites in China. A total of 249 participants 18 to 65 years old with migraine without aura based on the criteria of the International Headache Society, with migraine occurring 2 to 8 times per month. Participants in the true acupuncture and sham acupuncture groups received treatment 5 days per week for 4 weeks for a total of 20 sessions. Participants in the waiting-list group did not receive acupuncture but were informed that 20 sessions of acupuncture would be provided free of charge at the end of the trial. Participants used diaries to record migraine attacks. The primary outcome was the change in the frequency of migraine attacks from baseline to week 16. Secondary outcome measures included the migraine days, average headache severity, and medication intake every 4 weeks within 24 weeks. A total of 249 participants 18 to 65 years old were enrolled, and 245 were included in the intention-to-treat analyses. One hundred eighty-nine (77.1%) were women. Baseline characteristics were comparable across the 3 groups. The mean (SD) change in frequency of migraine attacks differed significantly among the 3 groups at 16 weeks after randomization (P acupuncture group by 3.2 (2.1), in the sham acupuncture group by 2.1 (2.5), and the waiting-list group by 1.4 (2.5); a greater reduction was observed in the true acupuncture than in the sham acupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and in the true

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

    Science.gov (United States)

    Evans, Abigail T; Peters, Ellen; Strasser, Andrew A; Emery, Lydia F; Sheerin, Kaitlin M; Romer, Daniel

    2015-01-01

    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 in encouraging

  19. 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

  20. Randomized clinical trial of 3 types of physical exercise for patients with Parkinson disease.

    Science.gov (United States)

    Shulman, Lisa M; Katzel, Leslie I; Ivey, Frederick M; Sorkin, John D; Favors, Knachelle; Anderson, Karen E; Smith, Barbara A; Reich, Stephen G; Weiner, William J; Macko, Richard F

    2013-02-01

    To compare the efficacy of treadmill exercises and stretching and resistance exercises in improving gait speed, strength, and fitness for patients with Parkinson disease. A comparative, prospective, randomized, single-blinded clinical trial of 3 types of physical exercise. The Parkinson's Disease and Movement Disorders Center at the University of Maryland and the Baltimore Veterans Affairs Medical Center, Geriatric Research Education and Clinical Center. A total of 67 patients with Parkinson disease who had gait impairment were randomly assigned to 1 of 3 arms of the trial. INTERVENTIONS; (1) A higher-intensity treadmill exercise (30 minutes at 70%-80% of heart rate reserve), (2) a lower-intensity treadmill exercise (50 minutes at 40%-50% of heart rate reserve), and (3) stretching and resistance exercises (2 sets of 10 repetitions on each leg on 3 resistance machines [leg press, leg extension, and curl]). These exercises were performed 3 times a week for 3 months. The primary outcome measures were gait speed (6-minute walk), cardiovascular fitness (peak oxygen consumption per unit time [$$ VO2], and muscle strength (1-repetition maximum strength). All 3 types of physical exercise improved distance on the 6-minute walk: lower-intensity treadmill exercise (12% increase; P=.001), stretching and resistance exercises (9% increase; Pexercise (6% increase; P=.07), with no between-group differences. Both treadmill exercises improved peak $$ VO2 (7%-8% increase; Pexercises. Only stretching and resistance improved muscle strength (16% increase; Pexercise were seen across all 3 exercise groups. The lower-intensity treadmill exercise resulted in the greatest improvement in gait speed. Both the higher- and lower-intensity treadmill exercises improved cardiovascular fitness. Only the stretching and resistance exercises improved muscle strength. Therefore, exercise can improve gait speed, muscle strength, and fitness for patients with Parkinson disease. The combination of

  1. Randomized clinical trial on the use of antispasmodic drugs in barium enema: impact on radiological practice

    Energy Technology Data Exchange (ETDEWEB)

    Goei, Reginald; Kessels, Alphons H.; Nix, Maarten; Knipschild, Paul G

    2000-10-01

    Purpose: To assess the willingness of radiologists to change their practice when the results of a randomized clinical trial (RCT) on the use of antispasmodic drugs in barium enema are presented. Materials and Methods: During the years 1994 and 1995 two postal questionnaires were sent to 481 practicing radiologists who were all members of the Netherlands Society of Radiology. In the first questionnaire the respondents were asked to give the characteristics of their practices in performing daily barium enema. The data from this questionnaire was used as a reference. The second questionnaire was sent to the respondents together with an abstract on the randomized clinical trial supporting the use of antispasmodic drugs in barium enema. We also indicated a preference for Buscopan over Glucagon as the antispasmodic drug. The willingness to change prescription habits was measured by comparing the data of the two questionnaires. Results: Of 481 practicing radiologists, 312 responded to the first questionnaire and gave information of their prescription habits (response rate 64%). These 312 responders were sent an abstract of the RCT and were asked to fill out a second questionnaire to determine their willingness to change their practice. Two hundred and sixty-seven radiologists responded (response rate 86%). A significant number of 119 (51%) were willing to increase the use of antispasmodic drugs. A significant number of 128 (55%) chose to increase the use of Buscopan, while a significant number of 81 (32%) were willing to decrease the use of Glucagon. Conclusion: Direct exposure to the results of an RCT recommending the use of antispasmodic drugs in barium enema, especially Buscopan, is likely to increase its use by practicing radiologists.

  2. A Bayesian meta-analytic approach for safety signal detection in randomized clinical trials.

    Science.gov (United States)

    Odani, Motoi; Fukimbara, Satoru; Sato, Tosiya

    2017-04-01

    Meta-analyses are frequently performed on adverse event data and are primarily used for improving statistical power to detect safety signals. However, in the evaluation of drug safety for New Drug Applications, simple pooling of adverse event data from multiple clinical trials is still commonly used. We sought to propose a new Bayesian hierarchical meta-analytic approach based on consideration of a hierarchical structure of reported individual adverse event data from multiple randomized clinical trials. To develop our meta-analysis model, we extended an existing three-stage Bayesian hierarchical model by including an additional stage of the clinical trial level in the hierarchical model; this generated a four-stage Bayesian hierarchical model. We applied the proposed Bayesian meta-analysis models to published adverse event data from three premarketing randomized clinical trials of tadalafil and to a simulation study motivated by the case example to evaluate the characteristics of three alternative models. Comparison of the results from the Bayesian meta-analysis model with those from Fisher's exact test after simple pooling showed that 6 out of 10 adverse events were the same within a top 10 ranking of individual adverse events with regard to association with treatment. However, more individual adverse events were detected in the Bayesian meta-analysis model than in Fisher's exact test under the body system "Musculoskeletal and connective tissue disorders." Moreover, comparison of the overall trend of estimates between the Bayesian model and the standard approach (odds ratios after simple pooling methods) revealed that the posterior median odds ratios for the Bayesian model for most adverse events shrank toward values for no association. Based on the simulation results, the Bayesian meta-analysis model could balance the false detection rate and power to a better extent than Fisher's exact test. For example, when the threshold value of the posterior probability for

  3. Randomized Controlled Trial of Antiseptic Hand Hygiene Methods in an Outpatient Surgery Clinic.

    Science.gov (United States)

    Therattil, Paul J; Yueh, Janet H; Kordahi, Anthony M; Cherla, Deepa V; Lee, Edward S; Granick, Mark S

    2015-12-01

    Outpatient wound care plays an integral part in any plastic surgery practice. However, compliance with hand hygiene measures has shown to be low, due to skin irritation and lack of time. The objective of this trial was to determine whether single-use, long-acting antiseptics can be as effective as standard multiple-use hand hygiene methods in an outpatient surgical setting. A prospective, randomized controlled trial was performed in the authors' outpatient plastic surgery clinic at Rutgers New Jersey Medical School, Newark, NJ to compare the efficacy of an ethyl alcohol-based sanitizer (Avagard D Instant Hand Aniseptic, 3M Health Care, St. Paul, MN), a benzalkonium chloride-based sanitizer (Soft & Shield, Bioderm Technologies, Inc, Trenton, NJ, distributed by NAPP Technologies, Hackensack, NJ ), and soap and- water handwashing. Subjects included clinic personnel, who were followed throughout the course of a 3-hour clinic session with hourly hand bacterial counts taken. During the course of the trial, 95 subjects completed the clinic session utilizing 1 of the hand hygiene methods (36 ethyl alcohol-based sanitizer, 38 benzalkonium chloride-based sanitizer, and 21 soap-and-water handwashing). There was no difference between hand bacterial counts using the different methods at 4 hourly time points (P greater than 0.05). Hand bacterial counts increased significantly over the 3-hour clinic session with the ethyl alcohol-based sanitizer (9.24 to 21.90 CFU, P less than 0.05), benzalkonium chloride-based sanitizer (6.69 to 21.59 CFU, P less than 0.05), and soap-and-water handwashing (8.43 to 22.75 CFU, P less than 0.05). There does not appear to be any difference in efficacy between single-use, long-acting sanitizer, and standard multiple-use hand hygiene methods. Hand bacterial counts increased significantly over the course of the 3-hour clinic session regardless of the hand hygiene measure used. Hand condition of subjects was improved with the ethyl alcohol

  4. Clinical and radiographic comparison of various medicaments used for pulpotomy in primary molars: A randomized clinical trial.

    Science.gov (United States)

    Goyal, Prachi; Pandit, I K; Gugnani, Neeraj; Gupta, Monica; Goel, Richa; Gambhir, Ramandeep Singh

    2016-01-01

    To evaluate and compare the efficacy of ferric sulfate, glutaraldehyde, and mineral trioxide aggregate (MTA) as pulpotomy medicaments in primary molars. This was a perspective randomized clinical trial. A total of 90 molars from 42 children aged 4-8 years were selected for pulpotomy procedure. Teeth were randomly divided into three equal groups of 30 teeth each. Teeth in Group I were intended to be treated with ferric sulfate, Group II were intended to be treated with buffered glutaraldehyde and Group III with MTA. All the molars were evaluated clinically at 24 h and both clinically and radio graphically at 1, 3, and 6 months. The observations were statistically analyzed using Chi-square test and Fisher's exact test. After 1 month, there was no clinical finding observed in all the three groups. At 3 months postoperative evaluation, 13.3% of teeth in Group I and 12.5% of teeth in Group II had mobility. At 6 months interval, pain and sinus formation each was noted in 9.1% of primary teeth in Group I while periodontal ligament widening was reported in 66.7% of teeth in Group I and 85.7% of teeth in Group II. MTA exhibited overall best results as pulpotomy agent for primary molars followed by 15.5% ferric sulfate, whereas 2% buffered glutaraldehyde was found to be least effective as a pulpotomy agent.

  5. Counselling sessions increased duration of exclusive breastfeeding: a randomized clinical trial with adolescent mothers and grandmothers

    Science.gov (United States)

    2014-01-01

    Background Considering that adolescent mothers may be more vulnerable to discontinuing exclusive breastfeeding (EBF) before 6 months and that their mothers may exert a negative influence on this practice, this study was conducted with the objective of evaluating the efficacy of breastfeeding counselling for adolescent mothers and their mothers in increasing EBF duration. Methods A clinical trial was performed in 323 adolescent mothers with newborns and their mothers randomized in four groups: (1) not living with mother, without intervention; (2) not living with mother, with intervention; (3) living with mother, without intervention, (4) living with mother, with intervention. The intervention consisted of five counselling sessions directed to mother and grandmother, in the maternity hospital and on follow-up. Information about feeding practices during the newborn’s first six months of life was collected monthly by telephone. Intervention’s efficacy was measured through Cox regression and comparison of exclusive breastfeeding medians and survival curves for the different groups. Results The intervention increased the duration of EBF by67 days for the group which included grandmothers (HR = 0.64; CI 95% = 0.46-0.90) and 46 days for the group which did not include grandmothers (HR = 0.52; CI 95% = 0.36-0.76). Conclusions Counselling sessions in the first four months of children’s lives proved to be effective in increasing EBF duration among adolescent mothers. Trial registration ClinicalTrials.gov NCT00910377. PMID:25033743

  6. Clinical Trials

    Medline Plus

    Full Text Available ... This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... educational programs and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board ... of a group of research and study topic experts. The NIH also requires ...

  8. Clinical Trials

    Medline Plus

    Full Text Available ... examples of clinical trials that test principles or strategies include studies that explore whether surgery or other medical treatments ... board consists of a group of research and study topic experts. The NIH also ... alternative strategies for diagnosis or treatment. In addition, the NIH ...

  9. Effectiveness of Earplugs in Preventing Recreational Noise-Induced Hearing Loss: A Randomized Clinical Trial.

    Science.gov (United States)

    Ramakers, Geerte G J; Kraaijenga, Véronique J C; Cattani, Guido; van Zanten, Gijsbert A; Grolman, Wilko

    2016-06-01

    The incidence of hearing loss has risen in past years. Attendance at music festivals and concerts may contribute to this increasing problem. To assess the effectiveness of earplugs in preventing temporary hearing loss immediately following music exposure. A randomized, single-blind clinical trial was conducted on September 5, 2015, at an outdoor music festival in Amsterdam, the Netherlands. Normal-hearing adult volunteers were recruited via social media. An exclusion criterion was the participants' intention to wear earplugs. Of the 86 volunteers assessed, 51 were included in the study. All analyses were performed on an intention-to-treat basis. Participants were randomly assigned to a group using earplugs or an unprotected group during a 4½-hour festival visit. The primary study outcome was a temporary threshold shift (TTS) on the audiogram, primarily for frequencies at 3 and 4 kHz. Secondary study outcomes included distortion product otoacoustic emission (DPOAE) measurements and claims of tinnitus using a questionnaire and tinnitus matching experiments. Of 51 participants included, 25 were randomized to the earplug group and 26 to the unprotected group. Nine in each group (36% and 35%, respectively) were men, and the mean (SD) ages were 27.3 (5.6) years in the earplug group and 27.0 (6.2) years in the unprotected group. Baseline demographics were similar in both groups. The time-averaged, equivalent A-weighted sound pressure level experienced was 100 dBA during the festival. A TTS over frequencies at 3 and 4 kHz after exposure was seen in 4 of 50 ears (8%) in the earplug group compared with 22 of 52 ears (42%) in the unprotected group (P earplug group. The number needed to treat with earplugs for preventing 1 TTS was 2.9. The DPOAE amplitudes decreased significantly more over the frequencies 2 to 8 kHz in the unprotected group: the mean (SD) decrease in magnitude was 0.6 (2.8) dB in the earplug group vs 2.2 (1.9) dB in the unprotected group (P = .04

  10. Health-related quality of life measurement in randomized clinical trials in surgical oncology

    NARCIS (Netherlands)

    Blazeby, Jane M.; Avery, Kerry; Sprangers, Mirjam; Pikhart, Hynek; Fayers, Peter; Donovan, Jenny

    2006-01-01

    PURPOSE: There is debate about the value of measuring health-related quality of life (HRQL) in clinical trials in oncology because of evidence suggesting that HRQL does not influence clinical decisions. Analysis of HRQL in surgical trials, however, may inform decision making because it provides

  11. Antimicrobial photodynamic therapy suppresses dental plaque formation in healthy adults: a randomized controlled clinical trial.

    Science.gov (United States)

    Ichinose-Tsuno, Akiko; Aoki, Akira; Takeuchi, Yasuo; Kirikae, Teruo; Shimbo, Takuro; Lee, Masaichi-Chang-Il; Yoshino, Fumihiko; Maruoka, Yutaka; Itoh, Toshiyuki; Ishikawa, Isao; Izumi, Yuichi

    2014-12-15

    Oral care is important for oral and systemic health, especially for elderly institutionalized individuals and compromised patients. However, conventional mechanical plaque control is often difficult for these patients because of the pain or the risk of aspiration. Although antimicrobial photodynamic therapy (aPDT), which is considered an alternative or adjunct to mechanical approaches, has potential application as a less stressful method of daily plaque control, no clinical application of this technique has been reported. We investigated the inhibitory effect of a combination of toluidine blue O (TBO), and a red light-emitting diode (LED) on dental plaque formation in healthy volunteers. The optimal concentration of TBO was determined in preliminary in vitro experiments to evaluate the bactericidal effect of aPDT on Streptococcus oralis and to clarify its safety in fibroblast cells. To survey the mechanism of TBO-mediated aPDT, the quality and quantity of reactive oxygen species (ROS) generated during aPDT were also examined using electron spin resonance (ESR) spectroscopy. Subsequently, the inhibitory effect of aPDT on dental plaque formation was investigated in eleven subjects as a clinical pilot study. The right or left mandibular premolars were randomly assigned to the treatment (with aPDT) or control (without aPDT) groups. In total, aPDT was applied six times (twice per day) to the teeth in the test group over a period of four days. On the fourth day, the study concluded and the analyses were performed. A combination of 500 or 1000 μg/ml TBO and LED irradiation for 20 s significantly decreased the number of colony forming units of Streptococcus oralis. The cytotoxicity of aPDT was comparable to that of standard antiseptics used in the oral cavity. Hydroxyl radicals were detected by ESR analysis, but singlet oxygen was not. A randomized controlled trial demonstrated that aPDT with 1000 μg/ml TBO and red LED irradiation significantly suppressed dental plaque

  12. Clinical pilates versus general exercise for chronic low back pain: randomized trial.

    Science.gov (United States)

    Wajswelner, Henry; Metcalf, Ben; Bennell, Kim

    2012-07-01

    This single-assessor-blinded randomized controlled trial aimed to compare the efficacy of physiotherapy-delivered clinical Pilates and general exercise for chronic low back pain. Eighty-seven community volunteers with low back pain for ≥3 months and age 18-70 were randomized to either the Pilates (n = 44) or general exercise (n = 43) group. The primary outcome was pain/disability measured with the Quebec scale. Secondary outcomes included pain on a numeric rating scale, Patient-Specific Functional Scale, Pain Self-efficacy Questionnaire, quality of life, and global perceived effect of treatment. All participants attended 60-min exercise sessions twice weekly for 6 wk supervised by a physiotherapist and performed daily home exercises that were continued during the follow-up. Participants from the clinical Pilates group received an individualized direction-specific exercise program prescribed by the physiotherapist after a clinical examination. The general exercise group received a generic set of exercises that were multidirectional and nonspecific. Outcomes were assessed after 6 wk (primary time point) and at 12 and 24 wk. Differences in mean change were compared between groups using ANCOVA adjusted for baseline values of the outcome. Eighty-three participants (96%) completed the 6-wk intervention and 60 (69%) completed the 24-wk follow-up. At 6 wk, no difference was found between groups for change in the Quebec scale (3.5, 95% confidence interval = -7.3 to 0.3, P = 0.07); both groups showed significant improvements. Similar results were found at the 12- and 24-wk follow-up and for the secondary outcome measures. An individualized clinical Pilates program produced similar beneficial effects on self-reported disability, pain, function and health-related quality of life as a general exercise program in community volunteers with chronic low back pain.

  13. Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial

    NARCIS (Netherlands)

    Lin, Carol Alice; Bhandari, Mohit; Guyatt, Gordon; Walter, Stephen D.; Schemitsch, Emil H.; Swiontkowski, Marc; Sanders, David; Tornetta, Paul; Sanders, David W.; Walter, Stephen; Sprague, Sheila; Heels-Ansdell, Diane; Buckingham, Lisa; Leece, Pamela; Viveiros, Helena; Mignott, Tashay; Ansell, Natalie; Sidorkewicz, Natalie; Agel, Julie; Bombardier, Claire; Berlin, Jesse A.; Bosse, Michael; Browner, Bruce; Gillespie, Brenda; Jones, Alan; O'Brien, Peter; Poolman, Rudolf; Macleod, Mark D.; Carey, Timothy; Leitch, Kellie; Bailey, Stuart; Gurr, Kevin; Konito, Ken; Bartha, Charlene; Low, Isolina; MacBean, Leila V.; Ramu, Mala; Reiber, Susan; Strapp, Ruth; Tieszer, Christina; Kreder, Hans J.; Stephen, David J. G.; Axelrod, Terry S.; Yee, Albert J. M.; Richards, Robin R.; Finkelstein, Joel; Gofton, Wade; Murnaghan, John; Schatztker, Joseph; Ford, Michael; Bulmer, Beverly; Conlan, Lisa; Laflamme, G. Yves; Berry, Gregory; Beaumont, Pierre; Ranger, Pierre; Laflamme, Georges-Henri; Gagnon, Sylvain; Malo, Michel; Fernandes, Julio; Poirier, Marie-France; McKee, Michael D.; Waddell, James P.; Bogoch, Earl R.; Daniels, Timothy R.; McBroom, Robert R.; Vicente, Milena R.; Storey, Wendy; Wild, Lisa M.; McCormack, Robert; Perey, Bertrand; Goetz, Thomas J.; Pate, Graham; Penner, Murray J.; Panagiotopoulos, Kostas; Pirani, Shafique; Dommisse, Ian G.; Loomer, Richard L.; Stone, Trevor; Moon, Karyn; Zomar, Mauri; Webb, Lawrence X.; Teasdall, Robert D.; Birkedal, John Peter; Martin, David Franklin; Ruch, David S.; Kilgus, Douglas J.; Pollock, David C.; Harris, Mitchel Brion; Wiesler, Ethan Ron; Ward, William G.; Shilt, Jeffrey Scott; Koman, Andrew L.; Poehling, Gary G.; Kulp, Brenda; Creevy, William R.; Stein, Andrew B.; Bono, Christopher T.; Einhorn, Thomas A.; Brown, T. Desmond; Pacicca, Donna; Sledge, John B.; Foster, Timothy E.; Voloshin, Ilva; Bolton, Jill; Carlisle, Hope; Shaughnessy, Lisa; Obremskey, William T.; LeCroy, C. Michael; Meinberg, Eric G.; Messer, Terry M.; Craig, William L.; Dirschl, Douglas R.; Caudle, Robert; Harris, Tim; Elhert, Kurt; Hage, William; Jones, Robert; Piedrahita, Luis; Schricker, Paul O.; Driver, Robin; Godwin, Jean; Kregor, Philip James; Tennent, Gregory; Truchan, Lisa M.; Sciadini, Marcus; Shuler, Franklin D.; Driver, Robin E.; Nading, Mary Alice; Neiderstadt, Jacky; Vap, Alexander R.; Vallier, Heather A.; Patterson, Brendan M.; Wilber, John H.; Wilber, Roger G.; Sontich, John K.; Moore, Timothy Alan; Brady, Drew; Cooperman, Daniel R.; Davis, John A.; Cureton, Beth Ann; Mandel, Scott; Orr, R. Douglas; Sadler, John T. S.; Hussain, Tousief; Rajaratnam, Krishan; Petrisor, Bradley; Drew, Brian; Bednar, Drew A.; Kwok, Desmond C. H.; Pettit, Shirley; Hancock, Jill; Cole, Peter A.; Smith, Joel J.; Brown, Gregory A.; Lange, Thomas A.; Stark, John G.; Levy, Bruce A.; Swiontkowski, Marc F.; Garaghty, Mary J.; Salzman, Joshua G.; Schutte, Carol A.; Tastad, Linda; Vang, Sandy; Seligson, David; Roberts, Craig S.; Malkani, Arthur L.; Sanders, Laura; Dyer, Carmen; Heinsen, Jessica; Smith, Langan; Madanagopal, Sudhakar; Frantz-Bush, Linda; Coupe, Kevin J.; Tucker, Jeffrey J.; Criswell, Allen R.; Buckle, Rosemary; Rechter, Alan Jeffrey; Sheth, Dhiren Shaskikant; Urquart, Brad; Trotscher, Thea; Anders, Mark J.; Kowalski, Joseph M.; Fineberg, Marc S.; Bone, Lawrence B.; Phillips, Matthew J.; Rohrbacher, Bernard; Stegemann, Philip; Mihalko, William M.; Buyea, Cathy; Augustine, Stephen J.; Jackson, William Thomas; Solis, Gregory; Ero, Sunday U.; Segina, Daniel N.; Berrey, Hudson B.; Agnew, Samuel G.; Fitzpatrick, Michael; Campbell, Lakina C.; Derting, Lynn; McAdams, June; Goslings, J. Carel; Ponsen, Kees Jan; Luitse, Jan; Kloen, Peter; Joosse, Pieter; Winkelhagen, Jasper; Duivenvoorden, Raphaël; Teague, David C.; Davey, Joseph; Sullivan, J. Andy; Ertl, William J. J.; Puckett, Timothy A.; Pasque, Charles B.; Tompkins, John F.; Gruel, Curtis R.; Kammerlocher, Paul; Lehman, Thomas P.; Puffinbarger, William R.; Carl, Kathy L.; Weber, Donald W.; Jomha, Nadr M.; Goplen, Gordon R.; Masson, Edward; Beaupre, Lauren A.; Greaves, Karen E.; Schaump, Lori N.; Jeray, Kyle J.; Goetz, David R.; Westberry, David E.; Broderick, J. Scott; Moon, Bryan S.; Tanner, Stephanie L.; Powell, James N.; Buckley, Richard E.; Elves, Leslie; Connolly, Stephen; Abraham, Edward P.; Steele, Trudy; Ellis, Thomas; Herzberg, Alex; Brown, George A.; Crawford, Dennis E.; Hart, Robert; Hayden, James; Orfaly, Robert M.; Vigland, Theodore; Vivekaraj, Maharani; Bundy, Gina L.; Miclau, Theodore; Matityahu, Amir; Coughlin, R. Richard; Kandemir, Utku; McClellan, R. Trigg; Lin, Cindy Hsin-Hua; Karges, David; Cramer, Kathryn; Watson, J. Tracy; Moed, Berton; Scott, Barbara; Beck, Dennis J.; Orth, Carolyn; Puskas, David; Clark, Russell; Jones, Jennifer; Egol, Kenneth A.; Paksima, Nader; France, Monet; Wai, Eugene K.; Johnson, Garth; Wilkinson, Ross; Gruszczynski, Adam T.; Vexler, Liisa

    2016-01-01

    To determine the extent to which knowledge from clinical trial protocols is transferred to nonparticipating patients. Retrospective review of prospectively collected data from a large clinical trial. Six level-1 international trauma centers. We compared rates and timing of reoperation in a subset of

  14. Azithromycin for Acute Exacerbations of Asthma : The AZALEA Randomized Clinical Trial.

    Science.gov (United States)

    Johnston, Sebastian L; Szigeti, Matyas; Cross, Mary; Brightling, Christopher; Chaudhuri, Rekha; Harrison, Timothy; Mansur, Adel; Robison, Laura; Sattar, Zahid; Jackson, David; Mallia, Patrick; Wong, Ernie; Corrigan, Christopher; Higgins, Bernard; Ind, Philip; Singh, Dave; Thomson, Neil C; Ashby, Deborah; Chauhan, Anoop

    2016-11-01

    Guidelines recommend against antibiotic use to treat asthma attacks. A study with telithromycin reported benefit, but adverse reactions limit its use. To determine whether azithromycin added to standard care for asthma attacks in adults results in clinical benefit. The Azithromycin Against Placebo in Exacerbations of Asthma (AZALEA) randomized, double-blind, placebo-controlled clinical trial, a United Kingdom-based multicenter study in adults requesting emergency care for acute asthma exacerbations, ran from September 2011 to April 2014. Adults with a history of asthma for more than 6 months were recruited within 48 hours of presentation to medical care with an acute deterioration in asthma control requiring a course of oral and/or systemic corticosteroids. Azithromycin 500 mg daily or matched placebo for 3 days. The primary outcome was diary card symptom score 10 days after randomization, with a hypothesized treatment effect size of -0.3. Secondary outcomes were diary card symptom score, quality-of-life questionnaires, and lung function changes, all between exacerbation and day 10, and time to a 50% reduction in symptom score. Of 4582 patients screened at 31 centers, 199 of a planned 380 were randomized within 48 hours of presentation. The major reason for nonrecruitment was receipt of antibiotics (2044 [44.6%] screened patients). Median time from presentation to drug administration was 22 hours (interquartile range, 14-28 hours). Exacerbation characteristics were well balanced across treatment arms and centers. The primary outcome asthma symptom scores were mean (SD), 4.14 (1.38) at exacerbation and 2.09 (1.71) at 10 days for the azithromycin group and 4.18 (1.48) and 2.20 (1.51) for the placebo group, respectively. Using multilevel modeling, there was no significant difference in symptom scores between azithromycin and placebo at day 10 (difference, -0.166; 95% CI, -0.670 to 0.337), nor on any day between exacerbation and day 10. No significant between

  15. Recruiting to Clinical Trials on the Telephone - a randomized controlled trial

    DEFF Research Database (Denmark)

    Foss, Kim Thestrup; Kjærgaard, Jesper; Stensballe, Lone Graff

    2016-01-01

    BACKGROUND: Informed consent is an essential element of clinical research. Obtaining consent, however, may be challenging. The use of the telephone for giving information and obtaining consent may be practical but little formal research has been done. METHODS: We examined the use of the telephone...

  16. Clinic and Home-Based Behavioral Intervention for Obesity in Preschoolers: A Randomized Trial.

    Science.gov (United States)

    Stark, Lori J; Spear Filigno, Stephanie; Bolling, Christopher; Ratcliff, Megan B; Kichler, Jessica C; Robson, Shannon M; Simon, Stacey L; McCullough, Mary Beth; Clifford, Lisa M; Odar Stough, Cathleen; Zion, Cynthia; Ittenbach, Richard F

    2018-01-01

    To test the hypotheses that an innovative skills-based behavioral family clinic and home-based intervention (LAUNCH) would reduce body mass index z score (BMIz) compared with motivational interviewing and to standard care in preschool-aged children with obesity. Randomized controlled trial with children between the ages of 2 and 5 years above the 95th percentile for body mass index for age and sex recruited from 27 pediatrician offices across 10 recruitment cycles between March 12, 2012 and June 8, 2015. Children were randomized to LAUNCH (an 18-session clinic and home-based behavioral intervention), motivational interviewing (delivered at the same frequency as LAUNCH), or standard care (no formal intervention). Weight and height were measured by assessors blinded to participant assignment. The primary outcome, BMIz at month 6 after adjusting for baseline BMIz, was tested separately comparing LAUNCH with motivational interviewing and LAUNCH with standard care using regression-based analysis of covariance models. A total of 151 of the 167 children randomized met intent-to-treat criteria and 92% completed the study. Children were 76% White and 57% female, with an average age of 55 months and BMI percentile of 98.57, with no demographic differences between the groups. LAUNCH participants demonstrated a significantly greater decrease in BMIz (mean = -0.32, SD = ±0.33) compared with motivational interviewing (mean = -0.05, SD = ±0.27), P behavioral skills-based intervention is necessary to reduce obesity. Clinicaltrials.gov NCT01546727. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. Multicenter Randomized Clinical Trial of Nonoperative Versus Operative Treatment of Acute Acromio-Clavicular Joint Dislocation.

    Science.gov (United States)

    2015-11-01

    To perform a randomized clinical trial of operative versus nonoperative treatment of acute acromio-clavicular (AC) joint dislocations using modern surgical fixation and both patient-based and surgeon-based outcome measures to determine which treatment method was superior. Prospective, randomized. Multicenter. Eight-three patients with acute (dislocations of the AC joint. Patients were randomized to operative repair with hook plate fixation versus nonoperative treatment (operative repair, 40; nonoperative treatment, 43). Disabilities of the Arm, Shoulder and Hand (DASH) score at 1 year after injury. Assessment also included a complete clinical assessment, evaluation of the constant score, and a radiographic evaluation at 6 weeks, and at 3, 6, 12, and 24 months. There were no demographic differences between the 2 groups, and the mechanisms of injury were similar between the 2 groups. The DASH scores (a disability score, lower score is better) were significantly better in the nonoperative group at 6 weeks (operative, 45; nonoperative, 31; P = 0.014) and 3 months (operative, 29; nonoperative, 16; P = 0.005). There were no significant differences between the groups at 6 months (operative, 14; nonoperative, 12; P = 0.442), 1 year (operative, 9; nonoperative, 9; P = 0.997), or 2 years (operative, 5; nonoperative, 6; P = 0.439) after injury. Constant scores were similar (better scores in the nonoperative group at 6 weeks, 3 months, and 6 months; P = 0.0001; and no difference thereafter). Although radiographic results were better in the operative group, the reoperation rate was significantly lower in the nonoperative group (P dislocations of the AC joint. The nonoperative group had better early scores, although both groups improved from a significant level of initial disability to a good or excellent result (mean DASH score, 5-6; mean constant score, 91-95) at 2 years. At present, there is no clear evidence that operative treatment with the currently available hook plate

  18. A randomized clinical trial of prophylaxis in children with hemophilia A (the ESPRIT Study).

    Science.gov (United States)

    Gringeri, A; Lundin, B; von Mackensen, S; Mantovani, L; Mannucci, P M

    2011-04-01

    Prevention of arthropathy is a major goal of hemophilia treatment. While studies in adults have demonstrated an impact of prophylaxis on the incidence of joint bleeds and patients' well-being in terms of improved quality of life (QoL), it is unclear whether or not prophylaxis influences the outcome and perception of well- of children with hemophilia. This randomized controlled study compared the efficacy of prophylaxis with episodic therapy in preventing hemarthroses and image-proven joint damage in children with severe hemophilia A (factor VIII <1%) over a 10-year time period. Forty-five children with severe hemophilia A, aged 1-7 years (median 4), with negative clinical-radiologic joint score at entry and at least one bleed during the previous 6 months, were consecutively randomized to prophylaxis with recombinant factor VIII (25 IU kg(-1) 3 × week) or episodic therapy with ≥25 IU kg(-1) every 12-24 h until complete clinical bleeding resolution. Safety, feasibility, direct costs and QoL were also evaluated. Twenty-one children were assigned to prophylaxis, 19 to episodic treatment. Children on prophylaxis had fewer hemarthroses than children on episodic therapy: 0.20 vs. 0.52 events per patient per month (P < 0.02). Plain-film radiology showed signs of arthropathy in six patients on prophylaxis (29%) vs. 14 on episodic treatment (74%) (P < 0.05). Prophylaxis was more effective when started early (≤36 months), with patients having fewer joint bleeds (0.12 joint bleeds per patient per month) and no radiologic signs of arthropathy. This randomized trial confirms the efficacy of prophylaxis in preventing bleeds and arthropathy in children with hemophilia, particularly when it is initiated early in life. © 2011 International Society on Thrombosis and Haemostasis.

  19. Contribution of Dry Needling to Individualized Physical Therapy Treatment of Shoulder Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Pérez-Palomares, Sara; Oliván-Blázquez, Bárbara; Pérez-Palomares, Ana; Gaspar-Calvo, Elena; Pérez-Benito, Marina; López-Lapeña, Elena; de la Torre-Beldarraín, Maria Luisa; Magallón-Botaya, Rosa

    2017-01-01

    Study Design Multicenter, parallel randomized clinical trial. Background Myofascial trigger points (MTrPs) are implicated in shoulder pain and functional limitations. An intervention intended to treat MTrPs is dry needling. Objectives To investigate the effectiveness of dry needling in addition to evidence-based personalized physical therapy treatment in the treatment of shoulder pain. Methods One hundred twenty patients with nonspecific shoulder pain were randomly allocated into 2 parallel groups: (1) personalized, evidencebased physical therapy treatment; and (2) trigger point dry needling in addition to personalized, evidence-based physical therapy treatment. Patients were assessed at baseline, posttreatment, and 3-month follow-up. The primary outcome measure was pain assessed by a visual analog scale at 3 months, and secondary variables were joint range-of-motion limitations, Constant-Murley score for pain and function, and number of active MTrPs. Clinical efficacy was assessed using intention-to-treat analysis. Results Of the 120 enrolled patients, 63 were randomly assigned to the control group and 57 to the intervention group. There were no significant differences in outcome between the 2 treatment groups. Both groups showed improvement over time. Conclusion Dry needling did not offer benefits in addition to personalized, evidencebased physical therapy treatment for patients with nonspecific shoulder pain. Level of Evidence Therapy, level 1b. Registered February 11, 2009 at www.isrctn.com (ISRCTN30907460). J Orthop Sports Phys Ther 2017;47(1):11-20. Epub 9 Dec 2016. doi:10.2519/jospt.2017.6698.

  20. [A systematic review of randomized controlled clinical trials of abdominal acupuncture treatment of cervical spondylosis].

    Science.gov (United States)

    Wang, Yan-wen; Fu, Wen-bin; Ou, Ai-hua; Fan, Ling; Huang, Ye-fei

    2011-04-01

    To assess the effect and methodological quality of clinically randomized controlled studies on abdominal acupuncture therapy for cervical spondylosis and to make out its current situation, validity and applicability. Using the PubMed, CNKI (China Academic Journals Full-text Database), VIP (VIP Chinese Science and Technology Periodicals Database) and Wanfang Digital Periodicals Electronic Database covering the period of 1989-2009, we did a literature search on the original articles of abdominal acupuncture treatment of cervical spondylosis and selected those accorded with the standards of randomized controlled studies. Animal studies, surveys, and news articles, and those duplicated, being absent in diagnostic criteria and non-randomized controlled trials were excluded. The papers' quality was analyzed by using the Jadad quality assessment scoring system and the therapeutic effect evaluated by using Review Manage 4.2.7 software. A total of 8 papers containing 909 cervical spondylosis patients and written in Chinese were included. These 8 studies used the effective rate as the primary outcome, 2 of them used the McGill Pain Questionnaire scales at the same time. Meta-analysis showed that the abdominal acupuncture group was better than the control group in visual analogue scale score (P acupuncture and routine acupuncture [OR = 3.29, 95% CI (0.13, 82.99)], EA [OR = 2.09, 95% CI (0.36, 11.95)] and traction therapy [OR = 6.06, 95% CI (3.01, 12.18)] in the total effective rate, pain rating index score [WMD = -2.24, 95% CI (-5.29, 0.81)] and the present pain intensity score [WMD = -0.84, 95% CI (-2.13, 0.44)]. At the present, there has been no sufficient evidence to ensure that in the treatment of cervical spondylosis, the abdominal acupuncture therapy is superior to routine acupuncture, EA and traction therapy. Attention should be paid to the randomized controlled study of larger samples and qualified design.

  1. Adjunctive Mitomycin C or Amniotic Membrane Transplantation for Ahmed Glaucoma Valve Implantation: A Randomized Clinical Trial.

    Science.gov (United States)

    Yazdani, Shahin; Mahboobipour, Hassan; Pakravan, Mohammad; Doozandeh, Azadeh; Ghahari, Elham

    2016-05-01

    To determine whether adjunctive mitomycin C (MMC) or amniotic membrane transplantation (AMT) improve the outcomes of Ahmed glaucoma valve (AGV) implantation. This double-blind, stratified, 3-armed randomized clinical trial includes 75 eyes of 75 patients aged 7 to 75 years with refractory glaucoma. Eligible subjects underwent stratified block randomization; eyes were first stratified to surgery in the superior or inferior quadrants based on feasibility; in each subgroup, eyes were randomly assigned to the study arms using random blocks: conventional AGV implantation (group A, 25 eyes), AGV with MMC (group B, 25 eyes), and AGV with AMT (group C, 25 eyes). The 3 study groups were comparable regarding baseline characteristics and mean follow-up (P=0.288). A total of 68 patients including 23 eyes in group A, 25 eyes in group B, and 20 eyes group C completed the follow-up period and were analyzed. Intraocular pressure was lower in the MMC group only 3 weeks postoperatively (P=0.04) but comparable at other time intervals. Overall success rate was comparable in the 3 groups at 12 months (P=0.217). The number of eyes requiring medications (P=0.30), time to initiation of medications (P=0.13), and number of medications (P=0.22) were comparable. Hypertensive phase was slightly but insignificantly more common with standard surgery (82%) as compared with MMC-augmented (60%) and AMT-augmented (70%) procedures (P=0.23). Complications were comparable over 1 year (P=0.28). Although adjunctive MMC and AMT were safe during AGV implantation, they did not influence success rates or intraocular pressure outcomes. Complications, including hypertensive phase, were also comparable.

  2. Evaluation of Wet Cupping Therapy: Systematic Review of Randomized Clinical Trials.

    Science.gov (United States)

    Al Bedah, Abdullah M N; Khalil, Mohamed K M; Posadzki, Paul; Sohaibani, Imen; Aboushanab, Tamer Shaaban; AlQaed, Meshari; Ali, Gazzaffi I M

    2016-10-01

    Wet cupping is a widely used traditional therapy in many countries, which justifies a continuous scientific evaluation of its efficacy and safety. To perform a systematic review to critically evaluate and update the available evidence of wet cupping in traditional and complementary medicine. Ten electronic databases were searched from their inceptions to February 2016. Included studies were randomized clinical trials (RCTs) that evaluated wet cupping against any type of control interventions in patients with any clinical condition, as well as healthy individuals. Cochrane risk of bias tool was used to appraise the included RCTs. Fourteen RCTs met the eligibility criteria. The included studies evaluated the following clinical conditions: nonspecific low back pain (NSLBP), hypertension, brachialgia, carpal tunnel syndrome (CTS), chronic neck pain, metabolic syndrome, migraine headaches, oxygen saturation in smokers with chronic obstructive pulmonary disease (COPD), and oral and genital ulcers due to Behçet disease. Two RCTs evaluated physiologic and biochemical parameters of healthy individuals. Overall, 9 RCTs favored wet cupping over various control interventions in NSLBP (n = 2), hypertension (n = 1), brachialgia (n = 1), CTS (n = 1), chronic neck pain (n = 2), oxygen saturation in smokers with COPD (n = 1), and oral and genital ulcers due to Behçet disease (n = 1). Five RCTs showed no statistically significant between-group differences: NSLBP (n = 1), metabolic syndrome (n = 1), migraine headaches (n = 1), and physiologic and biochemical parameters of healthy individuals (n = 2). Included RCTs had a variable risk of bias across all domains and suffered methodologic limitations. There is a promising evidence in favor of the use of wet cupping for musculoskeletal pain, specifically NSLBP, neck pain, CTS, and brachialgia. Better-quality trials are needed to generate solid evidence and firmly inform policy makers.

  3. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of Intermediate Care Clinics for Diabetes (ICCD: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Armstrong Natalie

    2012-09-01

    Full Text Available Abstract Background World-wide healthcare systems are faced with an epidemic of type 2 diabetes. In the United Kingdom, clinical care is primarily provided by general practitioners (GPs rather than hospital specialists. Intermediate care clinics for diabetes (ICCD potentially provide a model for supporting GPs in their care of people with poorly controlled type 2 diabetes and in their management of cardiovascular risk factors. This study aims to (1 compare patients with type 2 diabetes registered with practices that have access to an ICCD service with those that have access only to usual hospital care; (2 assess the cost-effectiveness of the intervention; and (3 explore the views and experiences of patients, health professionals and other stakeholders. Methods/Design This two-arm cluster randomized controlled trial (with integral economic evaluation and qualitative study is set in general practices in three UK Primary Care Trusts. Practices are randomized to one of two groups with patients referred to either an ICCD (intervention or to hospital care (control. Intervention group: GP practices in the intervention arm have the opportunity to refer patients to an ICCD - a multidisciplinary team led by a specialist nurse and a diabetologist. Patients are reviewed and managed in the ICCD for a short period with a goal of improving diabetes and cardiovascular risk factor control and are then referred back to practice. or Control group: Standard GP care, with referral to secondary care as required, but no access to ICCD. Participants are adults aged 18 years or older who have type 2 diabetes that is difficult for their GPs to control. The primary outcome is the proportion of participants reaching three risk factor targets: HbA1c (≤7.0%; blood pressure ( Discussion Forty-nine practices have been randomized, 1,997 patients have been recruited to the trial, and 20 patients have been recruited to the qualitative study. Results will be available late 2012

  4. Ozone as an adjunct to conventional nonsurgical therapy in chronic periodontitis: a randomized controlled clinical trial.

    Science.gov (United States)

    Al Habashneh, R; Alsalman, W; Khader, Y

    2015-02-01

    Currently, only limited data are available from controlled clinical trials regarding the effect of irrigation by ozonated water in the treatment of periodontitis. The aim of the present study was to determine the clinical and biological effects of the adjunctive use of ozone in nonsurgical periodontal treatment. Forty-one patients with chronic periodontitis were randomized to treatment with either subgingival scaling and root planing (SRP) followed by irrigation with ozonated water (test) or subgingival SRP followed by irrigation with distilled water irrigation (control). The following parameters were evaluated at baseline (T0), 3 mo (T1): plaque index; gingival index; bleeding on probing; probing pocket depth; gingival recession; and clinical attachment loss. In addition, the serum concentrations of high sensitivity C-reactive protein were measured at T0 and T1. Forty-one patients with chronic periodontitis were included in the analysis (20 in the test group and 21 in the control group). There was statistically significant improvement in the study parameters in both groups between T0 and T1, except for gingival index. However, there were no significant differences in any study parameter between test and control groups. Irrigation with ozonated water as an adjunctive therapy to SRP produces no statistically significant benefit compared with SRP plus distilled water irrigation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  5. Engaging Nurses in Research for a Randomized Clinical Trial of a Behavioral Health Intervention

    Directory of Open Access Journals (Sweden)

    Lona Roll

    2013-01-01

    Full Text Available Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings.

  6. Adjunctive use of essential oils following scaling and root planing -a randomized clinical trial.

    Science.gov (United States)

    Azad, Mohammad Fallah; Schwiertz, Andreas; Jentsch, Holger F R

    2016-06-07

    Hitherto no study has been published on the effect of the adjunctive administration of essential oils following scaling and root planing (SRP). This study describes the effect of a mouthrinse consisting of essential oils (Cymbopogon flexuosus, Thymus zygis and Rosmarinus officinalis) following SRP by clinical and microbiological variables in patients with generalized moderate chronic periodontitis. Forty-six patients (aged 40-65 years) with moderate chronic periodontitis were randomized in a double-blind study and rinsed their oral cavity following SRP with an essential oil mouthrinse (n  =  23) or placebo (n  =  23) for 14 days. Probing depth (PD), attachment level (AL), bleeding on probing (BOP) and modified sulcus bleeding index (SBI) were recorded at baseline and after 3 and 6 months. Subgingival plaque was taken for assessment of major bacteria associated with periodontitis. AL, PD, BOP and SBI were significantly improved in both groups after three (p   essential oils following SRP has a positive effect on clinical variables and on bacterial levels in the subgingival biofilm. 332-12-24092012, DRKS 00009387, German Clinical Trials Register, Freiburg i. Br., 16.09.2015.

  7. Efficacy of auriculotherapy for the reduction of stress in nursing students: a randomized clinical trial.

    Science.gov (United States)

    do Prado, Juliana Miyuki; Kurebayashi, Leonice Fumiko Sato; da Silva, Maria Júlia Paes

    2012-01-01

    This study is a randomized single-blind trial, which aimed to evaluate the efficacy of true auriculotherapy and placebo auriculotherapy in reducing the stress levels of mid-level Nursing students of the School of Nursing of the Beneficência Portuguesa Hospital. Seventy-one students with average, high and very high scores, according to Vasconcellos' List of Stress Symptoms, were divided into three groups: Control (25), Auriculotherapy (24), and Placebo/Sham (22). They were evaluated at the baseline, 8th and 12th sessions and at the follow-up (15 days) and received Shen Men and Brainstem points (Auriculotherapy Group) and Wrist and Outer Ear points (Placebo/Sham Group). The analysis of variance (ANOVA) showed statistically significant differences between the Control/Auriculotherapy groups from the 8th session, which was maintained in the third and fourth evaluations (p=0.000) and between the Control/Placebo groups (pauriculotherapy obtained better responses (45.39%) than the placebo (34.18%) in the reduction of the stress, but further studies are recommended for the re-evaluation of the sham points for stress. ClinicalTrials.gov Identifier: NCT01420848.

  8. Efficacy of docosahexaenoic acid-choline-vitamin E in paediatric NASH: a randomized controlled clinical trial.

    Science.gov (United States)

    Zöhrer, Evelyn; Alisi, Anna; Jahnel, Jörg; Mosca, Antonella; Della Corte, Claudia; Crudele, Annalisa; Fauler, Günter; Nobili, Valerio

    2017-09-01

    Nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease, is one of the most common hepatic diseases in children. We conducted a randomized controlled clinical trial on children with biopsy-proven NASH based on a combinatorial nutritional approach compared with placebo. Participants were assigned to lifestyle modification plus placebo or lifestyle modification plus a mix containing docosahexaenoic acid, choline, and vitamin E (DHA-CHO-VE). Forty children and adolescents participated in the entire trial. The primary outcome was the improvement of liver hyperechogenicity. Secondary outcomes included alterations of alanine aminotransferase (ALT) and other metabolic parameters. Furthermore, changes of serum bile acids (BA) and plasma fibroblast growth factor 19 (FGF19) levels were evaluated as inverse biomarkers of disease severity. At the end of the study, we observed a significant decrease in severe steatosis in the treatment group (50% to 5%, p = 0.001). Furthermore, although the anthropometric and biochemical measurements in the placebo and DHA-CHO-VE groups were comparable at baseline, at the end of the study ALT and fasting glucose levels improved only in the treatment group. Finally, we found that BA levels were not influenced whereas FGF19 levels were significantly increased by DHA-CHO-VE. The results suggest that a combination of DHA, VE, and CHO could improve steatosis and reduce ALT and glucose levels in children with NASH. However, further studies are needed to assess the impact of a DHA and VE combination on repair of liver damage in paediatric NASH.

  9. Randomized clinical trial of propofol versus alfentanil for moderate procedural sedation in the emergency department.

    Science.gov (United States)

    Miner, James R; Driver, Brian E; Moore, Johanna C; Faegerstrom, Erik; Klein, Lauren; Prekker, Matthew; Cole, Jon B

    2017-10-01

    To compare the frequency of airway and respiratory adverse events leading to an intervention between moderate sedation using alfentanil or propofol. We performed a randomized clinical trial in which adults undergoing moderate sedation in the ED received either alfentanil or propofol. Our primary outcome was the frequency of airway and respiratory adverse events leading to an intervention. Other outcomes included sedation depth, efficacy, sedation time, patient satisfaction, pain, and satisfaction. 108 subjects completed the trial: 52 receiving alfentanil and 56 receiving propofol. Airway or respiratory adverse events leading to an intervention were similar between the two groups: 23% for alfentanil and 20% for propofol (p=0.657). There were no serious adverse events in any group. Secondary outcomes were notably different in the rate of reported pain (48% for alfentanil, 13% for propofol) and recall (75% for alfentanil, 23% for propofol) and similar in the rate of satisfaction with the procedure (87% for alfentanil, 84% for propofol). We found a similar frequency of airway and respiratory adverse events leading to intervention between alfentanil and propofol used for moderate procedural sedation. Both agents appear safe for moderate procedural sedation. Copyright © 2017 Elsevier Inc. All rights reserved.

  10. Randomized clinical trials in dentistry: Risks of bias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.

    Science.gov (United States)

    Saltaji, Humam; Armijo-Olivo, Susan; Cummings, Greta G; Amin, Maryam; Flores-Mir, Carlos

    2017-01-01

    To examine the risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions and the development of these aspects over time. We included 540 randomized clinical trials from 64 selected systematic reviews. We extracted, in duplicate, details from each of the selected randomized clinical trials with respect to publication and trial characteristics, reporting and methodologic characteristics, and Cochrane risk of bias domains. We analyzed data using logistic regression and Chi-square statistics. Sequence generation was assessed to be inadequate (at unclear or high risk of bias) in 68% (n = 367) of the trials, while allocation concealment was inadequate in the majority of trials (n = 464; 85.9%). Blinding of participants and blinding of the outcome assessment were judged to be inadequate in 28.5% (n = 154) and 40.5% (n = 219) of the trials, respectively. A sample size calculation before the initiation of the study was not performed/reported in 79.1% (n = 427) of the trials, while the sample size was assessed as adequate in only 17.6% (n = 95) of the trials. Two thirds of the trials were not described as double blinded (n = 358; 66.3%), while the method of blinding was appropriate in 53% (n = 286) of the trials. We identified a significant decrease over time (1955-2013) in the proportion of trials assessed as having inadequately addressed methodological quality items (P < 0.05) in 30 out of the 40 quality criteria, or as being inadequate (at high or unclear risk of bias) in five domains of the Cochrane risk of bias tool: sequence generation, allocation concealment, incomplete outcome data, other sources of bias, and overall risk of bias. The risks of bias, risks of random errors, reporting quality, and methodological quality of randomized clinical trials of oral health interventions have improved over time; however, further efforts that contribute to the development of more stringent

  11. Online video improves clinical outcomes in adults with atopic dermatitis: a randomized controlled trial.

    Science.gov (United States)

    Armstrong, April W; Kim, Randie H; Idriss, Nayla Z; Larsen, Larissa N; Lio, Peter A

    2011-03-01

    Atopic dermatitis (AD) is a chronic inflammatory skin disorder characterized by intense pruritus that causes significant disease and psychosocial burden in patients. Patient education has the potential to improve clinical outcomes and patient knowledge of this condition. We sought to assess the effectiveness of online video education at improving AD knowledge and disease severity compared with a written pamphlet, and to determine the usefulness and appeal of the two educational delivery vehicles. In a randomized controlled trial, 80 participants were randomized to receive either online video-based patient education or written pamphlet education about AD and its management. We assessed AD disease severity using the patient-oriented eczema measure (POEM) scale. AD knowledge was assessed with standardized questionnaires at baseline and after the 12-week intervention. All participants had similar baseline knowledge and AD severity at the beginning of the study. On study completion, improvements in AD knowledge assessed by questionnaire were significantly greater in the video group than the pamphlet group (3.05 vs 1.85, P = .011). Online video-based education resulted in greater improvement in clinical outcome, as measured by POEM, compared with pamphlet-based education (POEM score reduction of 3.30 vs 1.03, P = .0043). Finally, although the usefulness of both interventions was rated equally (P = .77), the online video was significantly more appealing than the pamphlet (P = .0086). This study is limited to AD in adults. Online video for patient education is an effective and appealing tool for improving clinical outcomes in adult patients with AD. Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  12. Crown vs. composite for post-retained restorations: A randomized clinical trial.

    Science.gov (United States)

    Skupien, Jovito Adiel; Cenci, Maximiliano Sérgio; Opdam, Niek Johannes; Kreulen, C M; Huysmans, Marie-Charlotte; Pereira-Cenci, Tatiana

    2016-05-01

    This randomized clinical trial compared the survival of composite resin restorations and metal-ceramic crowns on endodontically treated teeth that received a glass fiber post using 2 different cementation methods. Forty-seven patients (age 42.5 ± 11.5) with fifty-seven endodontically treated teeth with extensive coronal damage but always with one intact surface were randomly allocated according to the type of coronal restoration: metal-ceramic crown or composite resin. In case of crown restoration, a core buildup was performed with microhybrid composite resin. The dentin bonding agent and composite resin used were the same for both direct and indirect restorations. Descriptive analysis was performed using FDI clinical criteria and survival of restorations/teeth analyzed using Kaplan-Meier statistics and log-rank tests. 57 restorations (30 composite resin and 27 crowns) were made in 47 patients. The recall rate was 100% and follow up time ranged between 1 and 5 years. One tooth was extracted 11 months post-restoration due to root fracture (composite group). Eight composite restorations and one crown had reparable failures, all due to secondary caries or restoration fracture. The overall annual failure rate (AFR) was 0.92% after 50 months for success of the restorations, with 1.83% for the composite group and 0.26% for the metal-ceramic crown group. The log-rank test showed no difference for survival according to the type of restoration (p=0.344). However, for success rates, metal-ceramic crowns demonstrated better performance (p=0.022). Indirect restorations provided higher acceptable clinical performance and lower need for re-intervention, but both types of restorations presented good survival rates. (NCT01461239). When endodontically treated teeth with at least one intact surface must be restored, composite resin restorations and metal-ceramic crows are acceptable alternatives to achieve good survival and success rates. Copyright © 2016 Elsevier Ltd. All rights

  13. Amitriptyline Versus Pregabalin in Post Herpetic Neuralgia: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Arun Achar

    2013-09-01

    Full Text Available Objective: Post herpetic neuralgia is a most common complication of herpes zoster which is difficult to treat. Significant beneficial effects found when treated with antiviral, tricyclic antidepressant, anticonvulsive like gabapentine and pregabalin, opioid and non opioid analgesic etc. Primary prevention can also be done with vaccine. The aim of this randomized comparative study was to establish clinical efficacy with amitriptyline and pregabalin. Methods: An open ended randomized clinical trial was conducted to compared clinical efficacy of amitriptyline (n=25 and pregabalin (n=25. Amitriptyline was given 25 mg once daily and pregabalin 75 mg twice daily. Total period of treatment were 6 month and patients were reviewed at the end of 2months, 4months and 6months to evaluate the degree of improvement in pain perception and any adverse reaction. Results: Four types of patients were included in this study and among them thoracic type was the commonest (54%. It was followed by cervical (24%, trigeminal (16% and lumbosacral types (6%. According to VAS score, satisfactory significant improvements in pain perception was observed at the end of 2 months (36%vs 8%, p<0.05 and 4 months (61.9%vs 27.8%, p<0.05 in pregabalin group than amitriptyline group. The chances of improvement more than 6 times and 4 times higher in patients with pregabalin group than those in amitriptyline group. There is no significant improvement difference was noticed at the end of 6months between groups. However, improvement was 89%(OR=1.89, 95%CI: 0.53-6.68 higher in pregabalin group than amitriptyline group. More importantly dizziness was the commonest side effect in pregabalin group while dryness of mouth was the commonest side affect in amitriptyline group. Conclusion: In conclusion, therapy with pregabalin is better compare to amitriptyline in post herpetic neuralgia. However a similar study with larger augmentation is required to establish the findings.

  14. Does levodopa improve vision in albinism? Results of a randomized, controlled clinical trial.

    Science.gov (United States)

    Summers, C Gail; Connett, John E; Holleschau, Ann M; Anderson, Jennifer L; De Becker, Inge; McKay, Brian S; Brilliant, Murray H

    2014-11-01

    Dopamine is an intermediate product in the biosynthesis of melanin pigment, which is absent or reduced in albinism. Animal research has shown that supplying a precursor to dopamine, levodopa, may improve visual acuity in albinism by enhancing neural networks. This study examines the safety and effectiveness of levodopa on best-corrected visual acuity in human subjects with albinism. Prospective, randomized, placebo-controlled, double-masked clinical trial conducted at the University of Minnesota. Forty-five subjects with albinism. Subjects with albinism were randomly assigned to one of three treatment arms: levodopa 0.76 mg/kg with 25% carbidopa, levodopa 0.51 mg/kg with 25% carbidopa, or placebo and followed for 20 weeks, with best-corrected visual acuity measured at enrollment, and at weeks 5, 10, 15, and 20 after enrollment. Side-effects were recorded with a symptom survey. Blood was drawn for genotyping. Side-effects and best-corrected visual acuity 20 weeks after enrolment. All subjects had at least one mutation found in a gene known to cause albinism. Mean age was 14.5 years (range: 3.5 to 57.8 years). Follow up was 100% and compliance was good. Minor side-effects were reported; there were no serious adverse events. There was no statistically significant improvement in best-corrected visual acuity after 20 weeks with either dose of levodopa. Levodopa, in the doses used in this trial and for the time course of administration, did not improve visual acuity in subjects with albinism. © 2014 Royal Australian and New Zealand College of Ophthalmologists.

  15. The Use of Wet Cupping for Persistent Nonspecific Low Back Pain: Randomized Controlled Clinical Trial.

    Science.gov (United States)

    AlBedah, Abdullah; Khalil, Mohamed; Elolemy, Ahmed; Hussein, Asim A; AlQaed, Meshari; Al Mudaiheem, Abdullah; Abutalib, Raid A; Bazaid, Faisal Mohamed; Bafail, Ahmad Saeed; Essa, AboBakr; Bakrain, Mohammed Yahia

    2015-08-01

    To evaluate the effectiveness and safety of wet cupping therapy as a single treatment for persistent nonspecific low back pain (PNSLBP). Randomized controlled trial comparing wet cupping versus no treatment in PNSLBP. Outpatient clinic in three secondary care hospitals in Saudi Arabia. Eighty eligible participants with PNSLBP for at least 3 months were randomly allocated to an intervention group (n=40) or to a control group (n=40). Six wet cupping sessions within 2 weeks, each of which were done at two bladder meridian (BL) acupuncture points among BL23, BL24, and BL25. Only acetaminophen was allowed as a rescue treatment in both groups. The Numeric Rating Scale (NRS), McGill Present Pain Intensity (PPI), and Oswestry Disability Questionnaire (ODQ) were used as outcome measures. Numbers of acetaminophen tablets taken were compared at 4 weeks from baseline. Adverse events were recorded. At the end of the intervention, statistically significant differences in the three outcome measures favoring the wet cupping group compared with the control group were seen: NRS score, 29.2 (95% confidence interval [CI], 24.6-33.8) versus 57.9 (95% CI, 53.3-62.6), respectively; PPI score, 1.17 (95% CI, 0.96-1.4) versus 2.3 (95% CI, 2.1- 2.7); and ODQ score, 19.6 (95% CI, 16.5-22.7) versus 35.4 (95% CI, 32.3-38.5) (p=0.0001). This improvement continued for another 2 weeks after the end of the intervention. Acetaminophen was used less in the wet cupping group, but this difference was not statistically significant. No adverse events were reported. Wet cupping is potentially effective in reducing pain and improving disability associated with PNSLBP at least for 2 weeks after the end of the wet cupping period. Placebo-controlled trials are needed.

  16. How to deal with morning bad breath: A randomized, crossover clinical trial

    Directory of Open Access Journals (Sweden)

    Jeronimo M Oliveira-Neto

    2013-01-01

    Full Text Available Context: The absence of a protocol for the treatment of halitosis has led us to compare mouthrinses with mechanical oral hygiene procedures for treating morning breath by employing a hand-held sulfide monitor. Aims: To compare the efficacy of five modalities of treatment for controlling morning halitosis in subjects with no dental or periodontal disease. Settings and Design: This is a five-period, randomized, crossover clinical trial. Materials and Methods: Twenty volunteers were randomly assigned to the trial. Testing involved the use of a conventional tongue scraper, a tongue scraper joined to the back of a toothbrush′s head, two mouthrinses (0.05% cetylpyridinium chloride and 0.12% chlorhexidine digluconate and a soft-bristled toothbrush and fluoride toothpaste for practicing oral hygiene. Statistical Analysis Used: Data analysis was performed using SPSS version 17 for Windows and NCSS 2007 software (P < 0.05. The products and the periods were compared with each other using the Friedman′s test. When significant differences (P < 0.05 were determined, the products and periods were compared in pairs by using the Wilcoxon′s test and by adjusting the original significance level (0.05 for multiple comparisons by using the Bonferroni′s method. Results: The toothbrush′s tongue scraper was able to significantly reduce bad breath for up to 2 h. Chlorhexidine reduced bad breath only at the end of the second hour, an effect that lasted for 3 h. Conclusions: Mechanical tongue cleaning was able to immediately reduce bad breath for a short period, whereas chlorhexidine and mechanical oral hygiene reduced bad breath for longer periods, achieving the best results against morning breath.

  17. Orthodontics with Customized versus Noncustomized Appliances: A Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Penning, E W; Peerlings, R H J; Govers, J D M; Rischen, R J; Zinad, K; Bronkhorst, E M; Breuning, K H; Kuijpers-Jagtman, A M

    2017-12-01

    This randomized controlled trial aimed to evaluate the duration and outcome quality of orthodontic treatment with a customized fixed appliance system versus a noncustomized system. Patients ( n = 180) were randomized and received orthodontic treatment with the Insignia customized orthodontic system or the Damon Q noncustomized orthodontic system. The allocation sequence was concealed using identical, sequentially numbered, opaque, sealed envelopes. Patients with nonextraction treatment plans were treated by 2 equally experienced orthodontists. Pretreatment and posttreatment plaster casts were made for each patient, and the models were rated using the Peer Assessment Rating (PAR) score. Planning time, treatment duration, and numbers of loose brackets, visits, and complaints were recorded. The examined null hypothesis was that the customized appliance system was not associated with significantly ( P < 0.05) shorter treatment duration compared to a noncustomized appliance. We analyzed 85 patients in the customized group and 89 in the noncustomized group. Treatment duration was 1.29 ± 0.35 y in the customized group and 1.24 ± 0.37 y in the noncustomized group. In the customized group, the PAR score was 23.32 ± 9.15 pretreatment and 5.38 ± 3.75 posttreatment. In the noncustomized group, the PAR score was 21.84 ± 7.95 pretreatment and 5.93 ± 3.58 posttreatment. None of these outcomes significantly differed between groups. On the other hand, the orthodontist had a significant effect on treatment duration, quality of treatment outcome, and number of visits ( P < 0.05). A higher PAR score pretreatment was associated with increased treatment duration, posttreatment PAR, and number of visits ( P < 0.05). Compared to the noncustomized group, the customized group had more loose brackets, a longer planning time, and more complaints ( P < 0.05). The customized orthodontic system was not associated with significantly reduced treatment duration, and treatment quality was

  18. Remifentanil versus Fentanyl/Midazolam in Painless Reduction of Anterior Shoulder Dislocation; a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mohammad Gharavifard

    2016-04-01

    Full Text Available Introduction: Performance of painful diagnostic and therapeutic procedures is common in emergency department(ED, and procedural sedation and analgesia (PSA is a fundamental skill for every emergency physician.This studywas aim to compare the efficacy of remifentanil with fentanyl/midazolam in painless reduction of anteriorshoulder dislocation. Methods: In this randomized, double blind, clinical trial the procedural characteristics,patients satisfaction as well as adverse events were compared between fentanyl/midazolamand remifentanilfor PSA of 18–64 years old patients, which were presented to ED following anterior shoulder dislocation.Results: 96 cases were randomly allocated to two groups (86.5% male. There were no significant difference betweengroups regarding baseline characteristics. Remifentanil group had lower duration of procedure (2.5§1.6versus 4.6§1.8 minutes, p Ç 0.001, higher pain reduction (53.7§13.3 versus 33.5§19.6, p Ç 0.001, lower failurerate (1 (2.1% versus 15 (31.3%, p Ç 0.001, higher satisfaction (p Æ 0.005. Adverse events were seen in 12 (25%patients in midazolam/fentanyl and 8 (16.7% cases in remifentanil group (p Æ 0.122. Conclusion: It seemsthat use of remifentanil resulted in lower procedural time, lower failure rate, and lower pain during procedureas well as higher patient satisfaction in comparison with midazolam/fentanyl combination in anterior shoulderdislocation.

  19. Dance Improves Functionality and Psychosocial Adjustment in Cerebral Palsy: A Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Teixeira-Machado, Lavinia; Azevedo-Santos, Isabela; DeSantana, Josimari Melo

    2017-06-01

    This randomized controlled clinical trial aimed to investigate the effect of dance in the functionality and psychosocial adjustment of young subjects with cerebral palsy (CP). Twenty-six young subjects with CP, GMFCS (Gross Motor Function Classification System) levels from II to V, were randomized into two intervention groups: kinesiotherapy and dance (n = 13 each). Twenty-four sessions (1 hour, twice a week) were performed in both groups. Functional Independence Measure (FIM) and World Health Organization Disability Assessment Schedule (WHODAS) by International Classification of Functioning, Disability and Health (ICF) were used before and after each intervention. Dance increased the classification of functioning (P = 0.001), independence function (P = 0.004), self-care (P = 0.01), mobility (P = 0.008), locomotion (P = 0.01), communication (P = 0.02), psychosocial adjustments (P = 0.04), and cognitive function (P = 0.03). Intergroup analysis evidenced significantly greater improvements in classification of functioning (P = 0.0002), independence function (P = 0.0006), self-care (P = 0.01), mobility (P = 0.001), locomotion (P = 0.002), communication (P = 0.0001), psychosocial adjustments (P = 0.002), and cognitive function (P = 0.0001) in dance group. It was shown that this approach could have an influence on basic common points in the body and motion, including emotional and social aspects, supporting the concept of complex multimodal psychomotor adjustments. Dance promoted enhancement on functionality and social activities regarding psychosocial adjustments in cerebral palsy young subjects.

  20. Effect of respiratory rehabilitation before open cardiac surgery on respiratory function: a randomized clinical trial.

    Science.gov (United States)

    Shakouri, Seyed Kazem; Salekzamani, Yaghoub; Taghizadieh, Ali; Sabbagh-Jadid, Hamed; Soleymani, Jamal; Sahebi, Leyla; Sahebi, Roya

    2015-01-01

    Prevention of pulmonary complications after coronary artery bypass graft is attended as a very important issue. The aim of this study was to evaluate the role of pulmonary rehabilitation before surgery for reducing the risk of pulmonary complications after surgery. In a randomized clinical trial, 60 patients undergoing heart surgery were randomly divided into two groups A and B. Chest physiotherapy was performed before and after surgery on group A patients however it was done on group B's, only after surgery. Effects of preoperative pulmonary rehabilitation were compared between two groups, using spirometry and arterial blood gas (ABG). Thirty nine males (65%) and 21 females (35%) with mean age of 8.10 ± 9.56 were analyzed. The mean differences were statistically significant for predicted forced vital capacity (FVC) (CI 95%:1.3 to 8.7) and Predicted Peak Flow indices (PEF) (CI 95%: 1.9 to 9.4) of spirometry indicator, PCO2 index (of ABG parameter) (CI 95%: 1.4 to 8.9) and mean oxygen saturation (mean Spo2) (CI 95%: 0.6 to 1.7) of ABG index in two groups. The performance of pulmonary rehabilitation program before surgery is recommended, as it may result in the reduction of complications of heart surgery.

  1. Albendazole versus metronidazole in the treatment of adult giardiasis: a randomized, double-blind, clinical trial.

    Science.gov (United States)

    Cañete, Roberto; Rodríguez, Pablo; Mesa, Lumey; Brito, Katia; Prior, Ada; Guilhem, Dirce; Novaes, M R C G

    2012-01-01

    Albendazole (ABZ) is a benzimidazole carbamate compound currently in use for human medical practice against enterobiasis and soil-transmitted helminthiasis (STH); However, its spectrum of activity is broad and goes beyond these infections. This study compares the efficacy and safety of ABZ versus metronidazole (MTZ) in human giardiasis. A randomized, double-blind, clinical trial was carried out at the Centre of Hygiene, Epidemiology and Microbiology in Matanzas City, Cuba. Adult patients with confirmed symptomatic G. duodenalis mono-infection were randomly assigned to receive either ABZ [400 mg daily (n = 75)] or MTZ [250 mg t.i.d. (n = 75)], both for 5 days. Follow-up fecal samples were obtained at 3, 5, 7 days after treatment end. The efficacy was similar for both treatment groups: ABZ (82.6%) and MTZ (85.3%); p > 0.05. Side-effects including bitter taste, headache, vomiting and dizziness were significantly higher in the MTZ group. Abdominal pain was significantly higher in ABZ group. ABZ was found as effective as MTZ in the treatment of G. duodenalis infections in adult patients from Cuba and could be a useful drug in areas where co-infection with STH infections is common.

  2. A randomized clinical trial of a web-based tobacco cessation education program.

    Science.gov (United States)

    Gordon, Judith S; Mahabee-Gittens, E Melinda; Andrews, Judy A; Christiansen, Steven M; Byron, David J

    2013-02-01

    We report the results of a randomized clinical trial of a 3-hour, web-based, tobacco cessation education program, the Web-Based Respiratory Education About Tobacco and Health (WeBREATHe) program, for practicing pediatric respiratory therapists (RTs), registered nurses (RNs), and nurse practitioners (NPs). Two hundred fifteen RTs (n = 40), RNs (n = 163), and NPs (n = 12) employed at the Children's Hospital of Philadelphia and the Children's Hospital, University of Colorado at Denver, participated in this study. All study activities were completed online. After consenting, participants were randomly assigned to either the training (intervention) or delayed training (control) condition. The training condition consisted of a 3-hour continuing education unit course plus ongoing online resources. Participants were assessed at baseline, 1 week, and 3 months after enrollment. Participants in the training condition were more likely to increase their tobacco cessation intervention behaviors than their delayed training counterparts (F[1, 213] = 32.03, P education program in tobacco cessation designed specifically for pediatric RTs, RNs, and NPs. Engagement in WeBREATHe increased participants' tobacco cessation-related behaviors.

  3. Chest physiotherapy during immediate postoperative period among patients undergoing upper abdominal surgery: randomized clinical trial.

    Science.gov (United States)

    Manzano, Roberta Munhoz; Carvalho, Celso Ricardo Fernandes de; Saraiva-Romanholo, Beatriz Mangueira; Vieira, Joaquim Edson

    2008-09-01

    Abdominal surgical procedures increase pulmonary complication risks. The aim of this study was to evaluate the effectiveness of chest physiotherapy during the immediate postoperative period among patients undergoing elective upper abdominal surgery. This randomized clinical trial was performed in the post-anesthesia care unit of a public university hospital. Thirty-one adults were randomly assigned to control (n = 16) and chest physiotherapy (n = 15) groups. Spirometry, pulse oximetry and anamneses were performed preoperatively and on the second postoperative day. A visual pain scale was applied on the second postoperative day, before and after chest physiotherapy. The chest physiotherapy group received treatment at the post-anesthesia care unit, while the controls did not. Surgery duration, length of hospital stay and postoperative pulmonary complications were gathered from patients' medical records. The control and chest physiotherapy groups presented decreased spirometry values after surgery but without any difference between them (forced vital capacity from 83.5 +/- 17.1% to 62.7 +/- 16.9% and from 95.7 +/- 18.9% to 79.0 +/- 26.9%, respectively). In contrast, the chest physiotherapy group presented improved oxygen-hemoglobin saturation after chest physiotherapy during the immediate postoperative period (p postoperative day. The medical record data were similar between groups. Chest physiotherapy during the immediate postoperative period following upper abdominal surgery was effective for improving oxygen-hemoglobin saturation without increased abdominal pain. Breathing exercises could be adopted at post-anesthesia care units with benefits for patients.

  4. Aloe Vera Gel and Cesarean Wound Healing; A Randomized Controlled Clinical Trial

    Science.gov (United States)

    Molazem, Zahra; Mohseni, Fatemeh; Younesi, Masoumeh; Keshavarzi, Sareh

    2015-01-01

    Background: Failure in complete healing of the wound is one of the probable complications of cesarean. The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound. Methods: This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital (Gerash, Iran). The participants were randomly divided into two groups each containing 45 patients. In one group, the wound was dressed with aloe vera gel, while simple dressing was used in the control group. Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale. The data were analyzed through Chi-square and t-test. Results: The participants’ mean age was 27.56±4.20 in the aloe vera group and 26.62±4.88 in the control group, but the difference was not statistically significant. However, a significant difference was found between the two groups concerning body mass index, heart rate, and systolic blood pressure (Paloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation. These measures were respectively obtained as 42 and 41eight days after the operation. Conclusion: According to the findings of this study, the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel. PMID:25560349

  5. Teaching Emotional Intelligence to Intensive Care Unit Nurses and their General Health: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    F Sharif

    2013-07-01

    Full Text Available Background: Emotion and how people manage it is an important part of personality that would immensely affect their health. Investigations showed that emotional intelligence is significantly related to and can predict psychological health. Objective: To determine the effect of teaching emotional intelligence to intensive care unit nurses on their general health. Methods: This randomized clinical trial (registered as IRCT201208022812N9 was conducted on 52 of 200 in intensive care unit nurses affiliated to Shiraz University of Medical Sciences. They were recruited through purposeful convenience sampling and then randomly categorized into two groups. The intervention group members were trained in emotional intelligence. Bar-on emotional intelligence and Goldberg's general health questionnaires were administered to each participant before, immediately after, and one month after the intervention. Results: While the mean score of general health for the intervention group decreased from 25.4 before the intervention, to 18.1 immediately after the intervention and to 14.6 one month later, for the control group, it increased from 22.0, to 24.2 and to 26.5, respectively (p<0.001. Conclusion: Teaching emotional intelligence improved the general health of intensive care unit nurses.

  6. Evaluation of the effects of a diabetes educational program: a randomized clinical trial.

    Science.gov (United States)

    Torres, Heloísa de Carvalho; Pace, Ana Emília; Chaves, Fernanda Figueredo; Velasquez-Melendez, Gustavo; Reis, Ilka Afonso

    2018-02-05

    Evaluate the effectiveness of a diabetes mellitus educational program in primary health care. This cluster randomized trial was conducted in a sample of 470 people with type 2 diabetes mellitus from eight health units, randomly assigned to two groups: intervention (n = 231) and control (n = 239). The intervention group participated in the educational program composed of three strategies: group education, home visit, and telephone intervention. Simultaneously, the control group was monitored individually. Group monitoring took place over nine months in the year 2012. Clinical evaluations were performed at the initial time (T0), three (T3), six (T6) and nine (T9) months after the beginning of the intervention. After nine months of follow-up, 341 users remained in the study, 171 in the control group and 170 in the intervention group. The average age of users was 60.6 years. In both groups, statistically significant differences were observed in mean HbA1c levels over the follow-up time (p educational program model developed was effective to improve the glycemic control of the intervention group participants.

  7. Preventing excessive gestational weight gain among African American women: A randomized clinical trial.

    Science.gov (United States)

    Herring, Sharon J; Cruice, Jane F; Bennett, Gary G; Rose, Marisa Z; Davey, Adam; Foster, Gary D

    2016-01-01

    Evidence is lacking regarding effective weight control treatments in pregnancy for ethnic minority women with obesity. This study evaluated whether a technology-based behavioral intervention could decrease the proportion of African American women with overweight or obesity who exceeded Institute of Medicine (IOM) guidelines for gestational weight gain. We conducted a two-arm pilot randomized clinical trial. Participants were 66 socioeconomically disadvantaged African American pregnant women (12.5 ± 3.7 weeks' gestation; 36% overweight, 64% obesity) recruited from two outpatient obstetric practices at Temple University between 2013 and 2014. We randomized participants to usual care (n = 33) or a behavioral intervention (n = 33) that promoted weight control in pregnancy. The intervention included: (1) empirically supported behavior change goals; (2) interactive self-monitoring text messages; (3) biweekly health coach calls; and (4) skills training and support through Facebook. The intervention reduced the proportion of women who exceeded IOM guidelines compared to usual care (37% vs. 66%, P = 0.033). Intervention participants gained less weight during pregnancy (8.7 vs. 12.3 kg, adjusted mean difference: -3.1 kg, 95% CI: -6.2 to -0.1). No group differences in neonatal or obstetric outcomes were found. The intervention resulted in lower prevalence of excessive gestational weight gain. © 2015 The Obesity Society.

  8. Dry needling of the trapezius muscle in office workers with neck pain: a randomized clinical trial.

    Science.gov (United States)

    Cerezo-Téllez, Ester; Lacomba, María Torres; Fuentes-Gallardo, Isabel; Mayoral Del Moral, Orlando; Rodrigo-Medina, Beatriz; Gutiérrez Ortega, Carlos

    2016-09-01

    Neck pain is a frequent complaint in office workers. This pain can be caused by myofascial trigger points (MTrPs) in the trapezius muscle. This study aimed to determine the effectiveness of deep dry needling (DDN) of active MTrPs in the trapezius muscle. A randomized, single blinded clinical trial was carried out at the Physical Therapy Department at Physiotherapy in Women's Health Research Group at Physical Therapy Department of University of Alcalá, in Alcalá de Henares, Madrid, Spain. Forty-four office workers with neck pain and active MTrPs in the trapezius muscle were randomly allocated to either the DDN or the control group (CG). The participants in the DDN group were treated with DDN of all MTrPs found in the trapezius muscle. They also received passive stretch of the trapezius muscle. The CG received the same passive stretch of the trapezius muscle only. The primary outcome measure was subjective pain intensity, measured using a visual analogue scale (VAS). Secondary outcomes were pressure pain threshold (PPT), cervical range of motion (CROM) and muscle strength. Data were collected at baseline, after interventions and 15 days after the last treatment. Differences were found between the DDN group and the CG for the VAS (P stretch seems to be more effective than passive stretch only. The effects are maintained in the short term. The results support the use of DDN in the management of trapezius muscle myofascial pain syndrome in neck pain.

  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. VITAMINE E IN THE MANAGEMENT OF DRUG INDUCED TARDIVE DYSKINESIA: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

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    M KAR AHMADI

    2002-12-01

    Full Text Available Introduction. Expresssion of tardive dyskinesia as one of the side effects of antipsychotic drugs causes various problems in psychotic patients. It is the main cause of patient"s drug incompliance.Vitamine E with it"s antioxidants properties might be an effective treatment for tardive dyskinesia. Methods. In a randomized double blind clinical trial, thirty inpatients of the psychiatric hospital in Isfahan were studied. Patients were stratified according to their age, psychiatric disorder and duration, intensity of tardive dyskinesia and antipsychotic dosage. Then they were asssigned randomly into two groups. Vitamine E (600 mg/day was administered to interventional group (15 patients. Another group received placebo (15 patients. Treatment durated for 6 weeks. Abnormal Involuntary Movment Scale (AIMS was used to measure tardive dyskinesia intensity. Results. Average of disorder intensity in those who received vit. E, dropped down from 8.33/10 (befor treatment to 6.13/10 (after treatment. It means 26.3 percent reduction of tardive dyskinesia intensity. This difference was only 7.3 percent in control group. There were no statistical diffrence between two groups after treatment (P>0.05. Discussion. There is no statistical efficacy for vitamine E in the management of tardive dyskinesia. But it is recommended to make another study with more samples.

  11. Cumulative Hazard Ratio Estimation for Treatment Regimes in Sequentially Randomized Clinical Trials.

    Science.gov (United States)

    Tang, Xinyu; Wahed, Abdus S

    2015-05-01

    The proportional hazards model is widely used in survival analysis to allow adjustment for baseline covariates. The proportional hazard assumption may not be valid for treatment regimes that depend on intermediate responses to prior treatments received, and it is not clear how such a model can be adapted to clinical trials employing more than one randomization. Besides, since treatment is modified post-baseline, the hazards are unlikely to be proportional across treatment regimes. Although Lokhnygina and Helterbrand (Biometrics 63: 422-428, 2007) introduced the Cox regression method for two-stage randomization designs, their method can only be applied to test the equality of two treatment regimes that share the same maintenance therapy. Moreover, their method does not allow auxiliary variables to be included in the model nor does it account for treatment effects that are not constant over time. In this article, we propose a model that assumes proportionality across covariates within each treatment regime but not across treatment regimes. Comparisons among treatment regimes are performed by testing the log ratio of the estimated cumulative hazards. The ratio of the cumulative hazard across treatment regimes is estimated using a weighted Breslow-type statistic. A simulation study was conducted to evaluate the performance of the estimators and proposed tests.

  12. Randomized Double-blind Clinical Trial of Bleaching Products in Patients Wearing Orthodontic Devices.

    Science.gov (United States)

    Montenegro-Arana, A; Arana-Gordillo, L A; Farana, D; Davila-Sanchez, A; Jadad, E; Coelho, U; Gomes, Omm; Loguercio, A D

    2016-01-01

    This double-blind randomized clinical trial evaluated tooth sensitivity (TS) and the effectiveness (EF) of two types of bleaching agents (Trèswhite Ortho [TWO] and Trèswhite Supreme [TWS]) when used in patients wearing orthodontic appliances. Forty patients between the ages of 18 and 40 years were randomly stratified, with an equal allocation rate, into two groups (n=20), according to the bleaching agent applied. Tooth color of the six maxillary anterior teeth was measured before and after the treatment with a spectrophotometer. The TS was recorded on three scales before and during the bleaching treatment. With regard to EF, a significant reduction was found (ranging from 7.3-9.6 and 5.3-9.5 Vita scale units for TWO and TWS, respectively, p0.63). The number of patients with sensitivity was 58.8% and 73.3% for TWO and TWS groups, respectively (p=0.53); however, with each of the three scales used, the intensity of sensitivity was low and there was no statistical difference between TWO and TWS (p>0.05). In spite of producing a side effect of low TS, the two bleaching treatments tested were effective for dental bleaching in patients with fixed orthodontic appliances.

  13. Does group training during pregnancy prevent lumbopelvic pain? A randomized clinical trial.

    Science.gov (United States)

    Mørkved, Siv; Salvesen, Kjell Asmund; Schei, Berit; Lydersen, Stian; Bø, Kari

    2007-01-01

    Prevention of lumbopelvic pain in pregnancy has been sparsely studied. One aim of this study was to assess if a 12-week training program during pregnancy can prevent and/or treat lumbopelvic pain. A randomized controlled trial was conducted at Trondheim University Hospital and three outpatient physiotherapy clinics. Three hundred and one healthy nulliparous women were included at 20 weeks of pregnancy and randomly allocated to a training group (148) or a control group (153). The outcome measures were self-reported symptoms of lumbopelvic pain (once per week or more), sick leave, and functional status. Pain drawing was used to document the painful area of the body. The intervention included daily pelvic floor muscle training at home, and weekly group training over 12 weeks including aerobic exercises, pelvic floor muscle and additional exercises, and information related to pregnancy. At 36 weeks of gestation women in the training group were significantly less likely to report lumbopelvic pain: 65/148 (44%) versus 86/153 (56%) (p=0.03). Three months after delivery the difference was 39/148 (26%) in the training group versus 56/153 (37%) in the control group (p=0.06). There was no difference in sick leave during pregnancy, but women in the training group had significantly (p=0.01) higher scores on functional status. A 12-week specially designed training program during pregnancy was effective in preventing lumbopelvic pain in pregnancy.

  14. The effects of acupressure on labor pains during child birth: randomized clinical trial

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    Reginaldo Roque Mafetoni

    Full Text Available ABSTRACT Objective: to analyze the effects of acupressure on the sanyinjiao point for pregnant women in labor at public maternity wards. Method: single-blind controlled clinical trial, randomly done employing a pragmatic profile. We selected 156 pregnant women in their ≥ 37 week/s, who had cervical dilations of ≥ 4 cm and with two or more contractions in 10 minutes. The pregnant women were randomly divided into three groups at a university hospital in the suburbs of Sao Paulo, Brazil, in order to receive either acupressure treatment, a placebo or participate as part of a control group. The acupressure was applied on the sanyinjiao point during the contractions for 20 minutes. Then the intensity of the pain was evaluated using the Visual Analogue Scale (VAS. Results: The averages for the pain measured using the VAS were not different for the three groups that were a part of the study (p-value=0.0929, however they were less in the acupressure groups immediately after receiving the treatment (p-value=<0.0001. This was also the case where the treatment lasted for 1 hour (p-value=0.0001. This was the case in comparison with placebo and control groups. Conclusion: the use of acupressure on the sanyinjiao point is a useful way to alleviate pain in a non-invasive manner. It can improve the quality of care given to pregnant women in labor. Register: RBR-9mhs8r.

  15. Effect of olive oil massage on weight gain in preterm infants: A randomized controlled clinical trial.

    Science.gov (United States)

    Jabraeile, Mahnaz; Rasooly, Alehe Seyyed; Farshi, Mahni Rahkar; Malakouti, Jamileh

    2016-01-01

    Despite the fact that effect of massage with or without oil on the baby's weight gain is not clear, but recent studies have shown that massage with essential oils make lipid absorption through the skin. The aim of this study was to evaluate the effect of olive oil massage on weight gain in preterm infants. This study was a single-blind, randomized controlled clinical trial. In this study, infants who met inclusion criteria for the study were divided into two groups by using random numbers table. Newborns in intervention group were under massage for 10 days and 3 times for 15 min daily; the mother of these newborns had been trained already using olive oil. Moreover, the infants of the control group were under massaging without oil same as the above-mentioned method. Researchers weighed babies daily during 10 days and recorded it at the checklist. Data from the study were reviewed and analyzed by descriptive statistics and repeated measure test using the statistical software SPSS/13. This study showed that the neonatal weight gain in the infants with the oil massage was 21 g daily in average, whereas the increase in infant massage without oil was 7 g. This difference was statistically significant (P olive oil, it is recommended that nurses use oil in infant massage in the neonatal units.

  16. The effect of olive oil on prevention of striae gravidarum: a randomized controlled clinical trial.

    Science.gov (United States)

    Soltanipoor, F; Delaram, M; Taavoni, S; Haghani, H

    2012-10-01

    Striae gravidarum (SG) is one of the cutaneous physiological changes during pregnancy with a high prevalence. This study aimed to evaluate the effect of olive oil in prevention of SG. Randomized controlled clinical trial. Health care centers and three Hospitals affiliated to Tehran University of Medical Sciences. 100 nulliparous pregnant women. Fifty women were randomly allocated to each study group. The treatment group received 1 cc topical olive oil twice a day to apply on the abdominal skin in a gentle manner without massaging it until the delivery. Control group did not receive any cream or oil during the study. Development of SG and its severity was recorded at the end of the study. Although the frequency of severe SG was lower in the users of olive oil compared to the other group, no statistically significant difference was found between the two experimental groups and the control group in the incidence and the severity of SG. Olive oil reduces the incidence of severe SG and increases the incidence of mild SG, but it does not significantly reduce the incidence and the severity of SG and it could not be recommended for SG prevention. Copyright © 2012 Elsevier Ltd. All rights reserved.

  17. A randomized placebo-controlled clinical trial of phonophoresis for the treatment of chronic neck pain.

    Science.gov (United States)

    Durmus, Dilek; Alayli, Gamze; Tufekci, Tugce; Kuru, Omer

    2014-05-01

    The aim of this trial was to investigate and compare the effects of phonophoresis (PP), placebo PP and exercise therapies on pain, disability, sleep quality, and depression in the patients with chronic neck pain (CNP). This is a randomized, single-blind, placebo-controlled study. A total of 61 patients with definite CNP were included in this study. The patients were randomized into three groups. Group 1 (n = 21) received PP with capsaicin treatment and exercises. Group 2 (n = 20) received placebo PP with capsaicin and exercises. Group 3 (n = 20) was given only exercises. All of the programs were performed 3 days a week, for 6 weeks. The pain (visual analog scale), disability (the neck pain disability index), depression (Beck Depression Inventory scores), and sleep quality (Pittsburgh Sleep Quality Index) of all participants were evaluated. Measurements were taken before and after treatment. All of the groups showed statistically significant improvements in pain, disability, sleep quality, and depression. While there was no difference between groups regarding depression and sleep quality, intergroup comparison showed significant differences in pain and disability among three groups. These differences were statistically significant in group 1 and 2 compared to group 3, and also in group 1 compared to group 2. We observed that PP treatment was effective in the treatment for patients with CNP. A combination of PP with exercises can be used to obtain optimal clinical results.

  18. Increased Risk for Falling Associated with Subtle Cognitive Impairment: Secondary Analysis of a Randomized Clinical Trial

    Science.gov (United States)

    Gleason, Carey E.; Gangnon, Ronald E.; Fischer, Barbara L.; Mahoney, Jane E.

    2009-01-01

    Background/Aims Having dementia increases patients’ risk for accidental falls. However, it is unknown if having mild cognitive deficits also elevates a person's risk for falls. This study sought to clarify the relationship between subtle cognitive impairment, measured with a widely-used, clinic-based assessment, the Mini Mental State Exam (MMSE), and risk for falls. Methods In a secondary analysis of the Kenosha County Falls Prevention Study, a randomized controlled trial targeting older adults at risk for falls, we examined the association between baseline MMSE and prospective rate of falls over 12 months in 172 subjects randomized to control group. Results Using univariate analysis, the rate of falls increased with each unit decrease in MMSE score down to at least 22 (rate ratio 1.25, 95% confidence interval (CI) 1.09–1.45, p = 0.0026). Using stepwise multivariate regression, controlling for ability to perform activities of daily living, use of assistive device, current exercise, and arthritis, the association between MMSE score and falls rate persisted (rate ratio 1.20, 95% CI 1.03–1.40, p = 0.021). Conclusion Minimal decrements on the MMSE were associated with elevations in rate of falls, suggesting that subtle cognitive deficits reflected in MMSE scores above a cut-off consistent with a diagnosis of dementia, can influence risk for falls. PMID:19602883

  19. Early amniotomy after vaginal misoprostol for induction of labor: a randomized clinical trial.

    Science.gov (United States)

    Makarem, Mohamed H; Zahran, Kamal M; Abdellah, Mohamad S; Karen, Mohamed A

    2013-08-01

    To test the effectiveness and safety of early amniotomy after vaginal misoprostol for the induction of labor. A randomized clinical trial that included 320 women with medical or obstetric indication for labor induction. They were randomly assigned into two equal groups, amniotomy group and control group. Each participant received vaginal misoprostol 50 μg every 6 h for induction of labor. In amniotomy group, amniotomy was done in the early active phase of labor while in the control group, the membranes were left to rupture spontaneously or as judged by the senior resident in the duty. More subjects in the amniotomy group achieved vaginal delivery within 24 h than in the control group [117 (73.13 %) vs. 105 (65.63 %)]. Subjects in the amniotomy group reported shorter induction to delivery interval (09.72 ± 4.61 h vs. 13.61 ± 5.61, P = .002), and better neonatal outcome compared to the control group. There were no statistically significant differences between both group with regard to number of doses of misoprostol, need for oxytocin, Cesarean Section indication and maternal side effects. Early amniotomy after vaginal misoprostol for labor induction is associated with higher successful vaginal delivery rate, shorter labor duration and better neonatal outcome.

  20. Community Health Worker Support for Disadvantaged Patients With Multiple Chronic Diseases: A Randomized Clinical Trial.

    Science.gov (United States)

    Kangovi, Shreya; Mitra, Nandita; Grande, David; Huo, Hairong; Smith, Robyn A; Long, Judith A

    2017-10-01

    To determine whether a community health worker (CHW) intervention improved outcomes in a low-income population with multiple chronic conditions. We conducted a single-blind, randomized clinical trial in Philadelphia, Pennsylvania (2013-2014). Participants (n = 302) were high-poverty neighborhood residents, uninsured or publicly insured, and diagnosed with 2 or more chronic diseases (diabetes, obesity, tobacco dependence, hypertension). All patients set a disease-management goal. Patients randomly assigned to CHWs also received 6 months of support tailored to their goals and preferences. Support from CHWs (vs goal-setting alone) led to improvements in several chronic diseases (changes in glycosylated hemoglobin: -0.4 vs 0.0; body mass index: -0.3 vs -0.1; cigarettes per day: -5.5 vs -1.3; systolic blood pressure: -1.8 vs -11.2; overall P = .08), self-rated mental health (12-item Short Form survey; 2.3 vs -0.2; P = .008), and quality of care (Consumer Assessment of Healthcare Providers and Systems; 62.9% vs 38%; P < .001), while reducing hospitalization at 1 year by 28% (P = .11). There were no differences in patient activation or self-rated physical health. A standardized CHW intervention improved chronic disease control, mental health, quality of care, and hospitalizations and could be a useful population health management tool for health care systems. clinicaltrials.gov identifier: NCT01900470.

  1. Effect of NICU Department Orientation Program on Mother’s Anxiety: a Randomized Clinical Trial

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    Leila Valizadeh

    2016-09-01

    Full Text Available Introduction: Neonatal intensive care unit induces the high level of anxiety for mothers. The aim of this study was to evaluate the effectiveness of NICU orientation program on the anxiety of mothers who had preterm newborns hospitalized in NICU. Methods: This study was a randomized clinical trial (three parallel groups. Participants included 99 mothers with preterm newborns hospitalized in NICU of Al- Zahra hospital, affiliated to Tabriz University of Medical Sciences in 2015. Mothers were randomly assigned to one of three groups (film, booklet, and control. Mothers completed the State- Trait Anxiety Inventory before entering to the NICU, and then mothers in the experiment groups became familiar with the NICU environment through watching a film or reading booklet. After the first NICU visit, all mothers completed the STAI and Cattell's Anxiety Questionnaires. Data were analyzed using SPSS ver. 13 software. Results: There was no significant difference between three groups regarding state- trait anxiety before the intervention. After the first NICU visit, a significant reduction in maternal state anxiety was seen in the both experiment groups. There was no statistical significant difference regarding trait anxiety. Data obtained from Cattell's anxiety questionnaire after intervention, showed significant difference in state anxiety between groups. Conclusion: Employing film and booklet orientation strategy after preterm delivery can reduce the mother’s anxiety and beneficent for the mother, baby, family and health care system.

  2. Music listening for anxiety relief in children in the preoperative period: a randomized clinical trial

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    Mariana André Honorato Franzoi

    Full Text Available ABSTRACT Objective: to investigate the effects of music listening, for 15 minutes, on the preoperative anxiety levels in children undergoing elective surgery in comparison with conventional pediatric surgical care. Method: randomized controlled clinical trial pilot study with 52 children in the preoperative period, aged 3 to 12 years, undergoing elective surgery and randomly allocated in the experimental group (n = 26 and control group (n = 26. Anxiety was assessed in both groups by the application of the modified Yale Preoperative Anxiety Scale and measurement of the physiological variables, upon arrival and 15 minutes after the first measurement. Results: there was a statistically significant difference in preoperative anxiety between the two groups only in relation to the physiological variable, since the respiratory rate of preschool children in the experimental group reduced in the second measurement compared to the control group (p = 0.0453. The experimental group showed a statistically significant reduction in anxiety levels after 15 minutes of music listening (p = 0.0441, specifically with regard to the behavioral domains of activity, vocalization, emotional expression and apparent awakening state. Conclusion: music listening emerges as a potential nursing intervention for relief of preoperative anxiety in children undergoing surgical procedures. RBR-7mcr59.

  3. Aloe vera gel and cesarean wound healing; a randomized controlled clinical trial.

    Science.gov (United States)

    Molazem, Zahra; Mohseni, Fatemeh; Younesi, Masoumeh; Keshavarzi, Sareh

    2014-08-31

    Failure in complete healing of the wound is one of the probable complications of cesarean. The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound. This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital (Gerash, Iran). The participants were randomly divided into two groups each containing 45 patients. In one group, the wound was dressed with aloe vera gel, while simple dressing was used in the control group. Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale. The data were analyzed through Chi-square and t-test. The participants' mean age was 27.56±4.20 in the aloe vera group and 26.62±4.88 in the control group, but the difference was not statistically significant. However, a significant difference was found between the two groups concerning body mass index, heart rate, and systolic blood pressure (Paloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation. These measures were respectively obtained as 42 and 41eight days after the operation. According to the findings of this study, the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel.

  4. Chlorhexidine and gauze and tape dressings for central venous catheters: a randomized clinical trial

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    Edivane Pedrolo

    2014-10-01

    Full Text Available OBJECTIVE: to assess the effectiveness of the chlorhexidine antimicrobial dressing in comparison to the gauze and tape dressing in the use of central venous catheters.METHOD: a randomized clinical trial was conducted in the intensive care and adult semi intensive care units of a university hospital in the south of Brazil. The subjects were patients using short-term central venous catheters, randomly assigned to the intervention (chlorhexidine antimicrobial dressing or control (gauze and micro porous tape groups.RESULTS: a total of 85 patients were included: 43 in the intervention group and 42 in the control group. No statistically significant differences were found between dressings in regard to the occurrence of: primary bloodstream infections (p-value = 0.5170; local reactions to the dressing (p-value = 0.3774; and dressing fixation (p-value = 0.2739.CONCLUSION: both technologies are effective in covering central venous catheters in regard to the investigated variables and can be used for this purpose. Registry ECR: RBR-7b5ycz.

  5. Oral magnesium supplementation reduces the incidence of gastrointestinal complications following cardiac surgery: a randomized clinical trial.

    Science.gov (United States)

    Moradian, Seyed Tayeb; Ghiasi, Mohammad Saeid; Mohamadpour, Alireza; Siavash, Yadollah

    2017-02-01

    Gastrointestinal complications are common after coronary artery bypass graft surgery. These complications are ranged from nausea and vomiting to mesenteric ischemia and liver failure. It seems that nausea, vomiting, and constipation are related to magnesium deficiency. This study was designed to examine the effect of oral magnesium supplementation on the incidence of gastrointestinal complications in patients undergoing cardiac surgery. In a single blinded randomized clinical trial, 102 patients who were undergoing coronary artery bypass graft surgery were randomly allocated into two groups, 52 patients in the intervention and 50 patients in control group. Patients in the experimental group received 800 milligram magnesium oxide (2 tablets each of them containing 240 mg elemental magnesium) daily from the admission to discharge from hospital. The incidence of post-operative nausea and vomiting, constipation, and atrial fibrillation was compared between the groups. Our results showed that postoperative hypomagnesemia is present in 41.20 and 70.80 percent of the patients in the intervention and control group patients, respectively. The overall incidence of constipation was 62%. Patients who received magnesium supplementation experienced less atrial fibrillation, nausea, vomiting, and constipation. Our data showed that oral magnesium supplementation could reduce the postoperative complications. Despite the better status in the intervention group, the hypomagnesemia was present in many of intervention group patients. It seems that supplementation with higher doses is needed.

  6. Glenohumeral posterior mobilization versus conventional physiotherapy for primary adhesive capsulitis: a randomized clinical trial.

    Science.gov (United States)

    Gutiérrez Espinoza, Héctor Joaquín; Pavez, Francisco; Guajardo, Cristopher; Acosta, Manuel

    2015-09-22

    To compare the short-term efficacy of a glenohumeral posterior mobilization technique versus conventional physiotherapy for the improvement of the range of external rotation in patients with primary adhesive capsulitis of the shoulder. This is a randomized clinical trial conducted at Hospital Clinico San Borja Arriaran in Chile. Fifty-seven patients with an age range of 50 to 58 years old were enrolled in two groups. Both groups were randomized to receive a treatment of 10 sessions: the experimental group (n=29) received a glenohumeral posterior mobilization technique after training with a cycle ergometer, and the control group (n=28) received conventional physiotherapy. The primary outcome measure was range of passive movement in external rotation; secondary outcomes were forward flexion and shoulder abduction, pain perception using the visual analogue scale and functionality test using the Constant-Murley Score. The study had the statistical power to detect a difference of four degrees between the groups in the improvement of the range of external rotation at the end of the treatment period. The experimental group showed a significant improvement with a mean difference of 46.3 degrees (SD=8.7) compared to 18.1 (SD=7.2) in the control group (pphysiotherapy treatment. The degree of increase in shoulder external rotation is more than 20 degrees beyond the increase achieved with conventional treatment.

  7. Surgical-site infections and postoperative complications: agreement between the Danish Gynecological Cancer Database and a randomized clinical trial

    DEFF Research Database (Denmark)

    Antonsen, Sofie L; Meyhoff, Christian Sylvest; Lundvall, Lene

    2011-01-01

    -operation, urinary tract infection, pneumonia and sepsis. RESULTS: Surgical-site infection was found in 21 of 222 patients (9.5%) in the PROXI trial versus 6 of 222 patients (2.7%) in the DGCD (p infections were...... registered in the PROXI trial, but not in the DGCD. Agreements between secondary outcomes were very varying (kappa-value 0.77 for re-operation, 0.37 for urinary tract infections, 0.19 for sepsis and 0.18 for pneumonia). CONCLUSIONS: The randomized trial reported significantly more surgical-site infections......OBJECTIVE: Surgical-site infections are serious complications and thorough follow-up is important for accurate surveillance. We aimed to compare the frequency of complications recorded in a clinical quality database with those noted in a randomized clinical trial with follow-up visits. DESIGN...

  8. Using instrumental variables to disentangle treatment and placebo effects in blinded and unblinded randomized clinical trials influenced by unmeasured confounders

    Science.gov (United States)

    Chaibub Neto, Elias

    2016-11-01

    Clinical trials traditionally employ blinding as a design mechanism to reduce the influence of placebo effects. In practice, however, it can be difficult or impossible to blind study participants and unblinded trials are common in medical research. Here we show how instrumental variables can be used to quantify and disentangle treatment and placebo effects in randomized clinical trials comparing control and active treatments in the presence of confounders. The key idea is to use randomization to separately manipulate treatment assignment and psychological encouragement conversations/interactions that increase the participants’ desire for improved symptoms. The proposed approach is able to improve the estimation of treatment effects in blinded studies and, most importantly, opens the doors to account for placebo effects in unblinded trials.

  9. Effect of Three Interventions on Contact Lens Comfort in Symptomatic Wearers: A Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Maria Navascues-Cornago

    Full Text Available To investigate whether carrying out various interventions part way through the day influences comfort in symptomatic daily disposable (DD contact lens wearers.A subject-masked, randomized, controlled clinical trial was conducted in thirty symptomatic soft lens wearers who wore their habitual DD contact lenses bilaterally for 12 h on two separate days. Five hours after lens application, one of the following three interventions or a control was performed on each eye: replacing the existing lens with a new lens; removing and reapplying the same lens; performing a 'scleral swish'; and no action (control. Comfort scores were recorded using SMS text messages every hour following lens application using a 0 (causes pain to 100 (excellent comfort scale. Comfort scores before lens application, at 6 mins post-application, and at 6 mins post-intervention were also recorded.There was a significant reduction in comfort from pre-lens application to 6 mins post-application for all groups (all p0.05. After the intervention, comfort continued to decline (p<0.0001 with slightly lower mean scores for the control group compared to the new lens group (p = 0.003. Change in comfort relative to pre-intervention (5 h was similar for all groups (p = 0.81. There was no difference in comfort at 12 h between groups (p = 0.83.This work has confirmed that comfort shows a continual and significant decline over a 12-h wearing period in symptomatic DD contact lens wearers. None of the interventions investigated had any significant impact on end-of-day comfort. These data suggest discomfort in lens wearers is more heavily influenced by changes to the ocular environment rather than to the lens itself.Controlled-Trials.com ISRCTN10419752 http://www.controlled-trials.com/ISRCTN10419752.

  10. Clinical Inertia in a Randomized Trial of Telemedicine-Based Chronic Disease Management: Lessons Learned.

    Science.gov (United States)

    Barton, Anna Beth; Okorodudu, Daniel E; Bosworth, Hayden B; Crowley, Matthew J

    2018-01-17

    Treatment nonadherence and clinical inertia perpetuate poor cardiovascular disease (CVD) risk factor control. Telemedicine interventions may counter both treatment nonadherence and clinical inertia. We explored why a telemedicine intervention designed to reduce treatment nonadherence and clinical inertia did not improve CVD risk factor control, despite enhancing treatment adherence versus usual care. In this analysis of a randomized trial, we studied recipients of the 12-month telemedicine intervention. This intervention comprised two nurse-administered components: (1) monthly self-management education targeting improved treatment adherence; and (2) quarterly medication management facilitation designed to support treatment intensification by primary care (thereby reducing clinical inertia). For each medication management facilitation encounter, we ascertained whether patients met treatment goals, and if not, whether primary care recommended treatment intensification following the encounter. We assessed disease control associated with encounters, where intensification was/was not recommended. We examined 455 encounters across 182 intervention recipients (100% African Americans with type 2 diabetes). Even after accounting for valid reasons for deferring intensification (e.g., treatment nonadherence), intensification was not recommended in 67.5% of encounters in which hemoglobin A1c was above goal, 72.5% in which systolic blood pressure was above goal, and 73.9% in which low-density lipoprotein cholesterol was above goal. In each disease state, treatment intensification was more likely with poorer control. Despite enhancing treatment adherence, this intervention was unsuccessful in countering clinical inertia, likely explaining its lack of effect on CVD risk factors. We identify several lessons learned that may benefit investigators and healthcare systems.

  11. Clinical decision support tools for osteoporosis disease management: a systematic review of randomized controlled trials.

    Science.gov (United States)

    Kastner, Monika; Straus, Sharon E

    2008-12-01

    Studies indicate a gap between evidence and clinical practice in osteoporosis management. Tools that facilitate clinical decision making at the point of care are promising strategies for closing these practice gaps. To systematically review the literature to identify and describe the effectiveness of tools that support clinical decision making in osteoporosis disease management. Medline, EMBASE, CINAHL, and EBM Reviews (CDSR, DARE, CCTR, and ACP J Club), and contact with experts in the field. Randomized controlled trials (RCTs) in any language from 1966 to July 2006 investigating disease management interventions in patients at risk for osteoporosis. Outcomes included fractures and bone mineral density (BMD) testing. Two investigators independently assessed articles for relevance and study quality, and extracted data using standardized forms. Of 1,246 citations that were screened for relevance, 13 RCTs met the inclusion criteria. Reported study quality was generally poor. Meta-analysis was not done because of methodological and clinical heterogeneity; 77% of studies included a reminder or education as a component of their intervention. Three studies of reminders plus education targeted to physicians and patients showed increased BMD testing (RR range 1.43 to 8.67) and osteoporosis medication use (RR range 1.60 to 8.67). A physician reminder plus a patient risk assessment strategy found reduced fractures [RR 0.58, 95% confidence interval (CI) 0.37 to 0.90] and increased osteoporosis therapy (RR 2.44, CI 1.43 to 4.17). Multi-component tools that are targeted to physicians and patients may be effective for supporting clinical decision making in osteoporosis disease management.

  12. Randomized, controlled clinical trial of bilayer ceramic and metal-ceramic crown performance.

    Science.gov (United States)

    Esquivel-Upshaw, Josephine; Rose, William; Oliveira, Erica; Yang, Mark; Clark, Arthur E; Anusavice, Kenneth

    2013-04-01

    Analyzing the clinical performance of restorative materials is important, as there is an expectation that these materials and procedures will restore teeth and do no harm. The objective of this research study was to characterize the clinical performance of metal-ceramic crowns, core ceramic crowns, and core ceramic/veneer ceramic crowns based on 11 clinical criteria. An IRB-approved, randomized, controlled clinical trial was conducted as a single-blind pilot study. The following three types of full crowns were fabricated: (1) metal-ceramic crown (MC) made from a Pd-Au-Ag-Sn-In alloy (Argedent 62) and a glass-ceramic veneer (IPS d.SIGN veneer); (2) non-veneered (glazed) lithium disilicate glass-ceramic crown (LDC) (IPS e.max Press core and e.max Ceram Glaze); and (3) veneered lithia disilicate glass-ceramic crown (LDC/V) with glass-ceramic veneer (IPS Empress 2 core and IPS Eris). Single-unit crowns were randomly assigned. Patients were recalled for each of 3 years and were evaluated by two calibrated clinicians. Thirty-six crowns were placed in 31 patients. A total of 12 crowns of each of the three crown types were studied. Eleven criteria were evaluated: tissue health, marginal integrity, secondary caries, proximal contact, anatomic contour, occlusion, surface texture, cracks/chips (fractures), color match, tooth sensitivity, and wear (of crowns and opposing enamel). Numerical rankings ranged from 1 to 4, with 4 being excellent, and 1 indicating a need for immediate replacement. Statistical analysis of the numerical rankings was performed using a Fisher's exact test. There was no statistically significant difference between performance of the core ceramic crowns and the two veneered crowns at year 1 and year 2 (p > 0.05). All crowns were rated either as excellent or good for each of the clinical criteria; however, between years 2 and 3, gradual roughening of the occlusal surface occurred in some of the ceramic-ceramic crowns, possibly caused by dissolution and

  13. Randomized, Controlled Clinical Trial of Bilayer Ceramic and Metal-Ceramic Crown Performance

    Science.gov (United States)

    Esquivel-Upshaw, Josephine; Rose, William; Oliveira, Erica; Yang, Mark; Clark, Arthur E.; Anusavice, Kenneth

    2013-01-01

    Purpose Analyzing the clinical performance of restorative materials is important, as there is an expectation that these materials and procedures will restore teeth and do no harm. The objective of this research study was to characterize the clinical performance of metal-ceramic crowns, core ceramic crowns, and core ceramic/veneer ceramic crowns based on 11 clinical criteria. Materials and Methods An IRB-approved, randomized, controlled clinical trial was conducted as a single-blind pilot study. The following three types of full crowns were fabricated: (1) metal-ceramic crown (MC) made from a Pd-Au-Ag-Sn-In alloy (Argedent 62) and a glass-ceramic veneer (IPS d.SIGN veneer); (2) non-veneered (glazed) lithium disilicate glass-ceramic crown (LDC) (IPS e.max Press core and e.max Ceram Glaze); and (3) veneered lithia disilicate glass-ceramic crown (LDC/V) with glass-ceramic veneer (IPS Empress 2 core and IPS Eris). Single-unit crowns were randomly assigned. Patients were recalled for each of 3 years and were evaluated by two calibrated clinicians. Thirty-six crowns were placed in 31 patients. A total of 12 crowns of each of the three crown types were studied. Eleven criteria were evaluated: tissue health, marginal integrity, secondary caries, proximal contact, anatomic contour, occlusion, surface texture, cracks/chips (fractures), color match, tooth sensitivity, and wear (of crowns and opposing enamel). Numerical rankings ranged from 1 to 4, with 4 being excellent, and 1 indicating a need for immediate replacement. Statistical analysis of the numerical rankings was performed using a Fisher’s exact test. Results There was no statistically significant difference between performance of the core ceramic crowns and the two veneered crowns at year 1 and year 2 (p > 0.05). All crowns were rated either as excellent or good for each of the clinical criteria; however, between years 2 and 3, gradual roughening of the occlusal surface occurred in some of the ceramic-ceramic crowns

  14. Telecare collaborative management of chronic pain in primary care: a randomized clinical trial.

    Science.gov (United States)

    Kroenke, Kurt; Krebs, Erin E; Wu, Jingwei; Yu, Zhangsheng; Chumbler, Neale R; Bair, Matthew J

    2014-07-16

    Chronic musculoskeletal pain is among the most prevalent, costly, and disabling medical disorders. However, few clinical trials have examined interventions to improve chronic pain in primary care. To determine the effectiveness of a telecare intervention for chronic pain. The Stepped Care to Optimize Pain Care Effectiveness (SCOPE) study was a randomized trial comparing a telephone-delivered collaborative care management intervention vs usual care in 250 patients with chronic (≥3 months) musculoskeletal pain of at least moderate intensity (Brief Pain Inventory [BPI] score ≥5). Patients were enrolled from 5 primary care clinics in a single Veterans Affairs medical center from June 2010 through May 2012, with 12-month follow-up completed by June 2013. Patients were randomized either to an intervention group (n = 124) or to a usual care group whose members received all pain care as usual from their primary care physicians (n = 126). The intervention group received 12 months of telecare management that coupled automated symptom monitoring with an algorithm-guided stepped care approach to optimizing analgesics. Primary outcome was the BPI total score, which ranges from 0 ("no pain") to 10 ("pain as bad as you can imagine") and for which a 1-point change is considered clinically important. Secondary pain outcomes included BPI interference and severity, global pain improvement, treatment satisfaction, and use of opioids and other analgesics. Overall, mean (SD) baseline BPI scores in the intervention and control groups were 5.31 (1.81) and 5.12 (1.80), respectively. Compared with usual care, the intervention group had a 1.02-point lower (95% CI, -1.58 to -0.47) BPI score at 12 months (3.57 vs 4.59). Patients in the intervention group were nearly twice as likely to report at least a 30% improvement in their pain score by 12 months (51.7% vs 27.1%; relative risk, 1.9 [95% CI, 1.4 to 2.7]), with a number needed to treat of 4.1 (95% CI, 3.0 to 6.4) for a 30

  15. Diuretics vs. placebo for postpartum blood pressure control in preeclampsia (DIUPRE): a randomized clinical trial.

    Science.gov (United States)

    Cursino, Telma; Katz, Leila; Coutinho, Isabela; Amorim, Melania

    2015-08-05

    Hypertension affects about 10% of pregnancies and is responsible for both maternal and neonatal devastating complications such as eclampsia, HELLP syndrome, prematurity and maternal and neonatal death. The resolution of the disease occurs in the first twelve weeks postpartum. The behavior of blood pressure and occurrence of very high blood pressure episodes among women with severe preeclampsia is related to remodeling of the dynamics of body fluids with consequent increase in intravascular volume. The persistence of hypertension in critical levels results in increased puerperal morbidity. To evaluate the effectiveness of furosemide in accelerating blood pressure recovery among women with severe preeclampsia. A triple-masked placebo controlled clinical trial, will be conducted including 120 postpartum women with severe preeclampsia, after eclampsia prophylaxis with magnesium sulfate and with adequate diuresis. Women with chronic hypertension and users of diuretics will be deleted. Informed consent will be obtained from all participants. Patients will be randomized to receive furosemide (40 mg orally every twenty four hours) or placebo. The variables are systolic and diastolic blood pressure, frequency of hypertensive crises, need for maintenance of antihypertensive therapy, number of antihypertensive agents used to control blood pressure, urine output, length of hospital stay, adverse effects and maternal complications. This study was approved by the Research Ethics Committee in humans of our institution. All participants will be duly informed about the aims of the project and will be included only if they agree to participate voluntarily, signing the informed consent. This study was registered on Clinical Trials.gov under the number NCT02163655. ( http://clinicaltrials.gov/show/NCT02163655).

  16. A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial.

    Science.gov (United States)

    Allen, Kelli D; Yancy, William S; Bosworth, Hayden B; Coffman, Cynthia J; Jeffreys, Amy S; Datta, Santanu K; McDuffie, Jennifer; Strauss, Jennifer L; Oddone, Eugene Z

    2016-01-19

    Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused. To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes. Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740). Department of Veterans Affairs Medical Center in Durham, North Carolina. 30 providers (clusters) and 300 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record. The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes. At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ. The study was conducted in a single Veterans Affairs medical center. The combined patient and provider intervention resulted in

  17. Laminaria japonica combined with probiotics improves intestinal microbiota: a randomized clinical trial.

    Science.gov (United States)

    Ko, Seok-Jae; Kim, Jinsung; Han, Gajin; Kim, Seul-Ki; Kim, Hong-Geol; Yeo, Inkwon; Ryu, Bongha; Park, Jae-Woo

    2014-01-01

    Laminaria japonica--a widely used ingredient in seaweed kimchi--and lactic acid bacteria (LAB)--a main component of traditional fermented Korean food--may alter human intestinal microbiota composition and have a positive effect on various digestive problems. However, few clinical trials have investigated the potential benefits of L. japonica when combined with LAB for human intestinal microbiota. Therefore, this study was designed to evaluate the effects of L. japonica and representative LAB on the human intestine. Forty participants with no known digestive diseases were randomly assigned to one of the two combination groups: (1) L. japonica with LAB and (2) L. japonica with placebo LAB. The study agents were administered for 4 weeks with a 2-week follow-up period. The primary outcome measure was the number of each of the seven LAB species in the human intestine, and the secondary outcome measures included the Korean version of the Gastrointestinal Symptom Rating Scale, the World Health Organization Quality of Life, and bowel functions. The primary outcome was evaluated before and after administration of the study agents (0 and 4 weeks), and the secondary outcomes were evaluated at 0, 4, and 6 weeks. Four of the seven LAB species were found to be significantly increased in the L. japonica with the LAB group and five species were significantly different from those of the placebo group. The secondary outcome measures did not change significantly. In conclusion, L. japonica with LAB facilitated the proliferation of beneficial human intestinal microbiota. ( ClinicalTrials.gov NCT01651741).

  18. Resist diabetes: A randomized clinical trial for resistance training maintenance in adults with prediabetes.

    Directory of Open Access Journals (Sweden)

    Brenda M Davy

    Full Text Available To determine whether a social cognitive theory (SCT-based intervention improves resistance training (RT maintenance and strength, and reduces prediabetes prevalence.Sedentary, overweight/obese (BMI: 25-39.9 kg/m2 adults aged 50-69 (N = 170 with prediabetes participated in the 15-month trial. Participants completed a supervised 3-month RT (2×/wk phase and were randomly assigned (N = 159 to one of two 6-month maintenance conditions: SCT or standard care. Participants continued RT at a self-selected facility. The final 6-month period involved no contact. Assessments occurred at baseline and months 3, 9, and 15. The SCT faded-contact intervention consisted of nine tailored transition (i.e., supervised training to training alone and nine follow-up sessions. Standard care involved six generic follow-up sessions. Primary outcomes were prevalence of normoglycemia and muscular strength.The retention rate was 76%. Four serious adverse events were reported. After 3 months of RT, 34% of participants were no longer prediabetic. This prevalence of normoglycemia was maintained through month 15 (30%, with no group difference. There was an 18% increase in the odds of being normoglycemic for each % increase in fat-free mass. Increases in muscular strength were evident at month 3 and maintained through month 15 (P<0.001, which represented improvements of 21% and 14% for chest and leg press, respectively. Results did not demonstrate a greater reduction in prediabetes prevalence in the SCT condition.Resistance training is an effective, maintainable strategy for reducing prediabetes prevalence and increasing muscular strength. Future research which promotes RT initiation and maintenance in clinical and community settings is warranted.ClinicalTrials.gov NCT01112709.

  19. Occlusive vs gauze dressings for local wound care in surgical patients: a randomized clinical trial.

    Science.gov (United States)

    Ubbink, Dirk T; Vermeulen, Hester; Goossens, Astrid; Kelner, Raoul B; Schreuder, Sanne M; Lubbers, Maarten J

    2008-10-01

    To compare effectiveness and costs of gauze-based vs occlusive, moist-environment dressing principles. Randomized clinical trial. Academic Medical Center, Amsterdam, the Netherlands. Two hundred eighty-five hospitalized surgical patients with open wounds. Patients received occlusive (ie, foams, alginates, hydrogels, hydrocolloids, hydrofibers, or films) or gauze-based dressings until their wounds were completely healed. Primary end points were complete wound healing, pain during dressing changes, and costs. Secondary end point was length of hospital stay. Time to complete wound healing did not differ significantly between occlusive (median, 66 days; interquartile range [IQR], 29-133 days) and gauze-based dressing groups (median, 45 days; IQR, 26-106 days; log-rank P = .31). Postoperative wounds (62% of the wounds included) healed significantly (P = .02) quicker using gauze dressings (median, 45 days; IQR, 22-93 days vs median, 72 days; IQR, 36-132 days). Median pain scores were low and similar in the occlusive (0.90; IQR, 0.29-2.34) and the gauze (0.64; IQR, 0.22-1.95) groups (P = .32). Daily costs of occlusive materials were significantly higher (occlusive, euro6.34 [US $9.95] vs gauze, euro1.85 [US $2.90]; P wound care per patient per day during hospitalization was euro7.48 (US $11.74) in the occlusive group and euro3.98 (US $6.25) in the gauze-based group (P = .002). The occlusive, moist-environment dressing principle in the clinical surgical setting does not lead to quicker wound healing or less pain than gauze dressings. The lower costs of less frequent dressing changes do not balance the higher costs of occlusive materials. Trial Registration trialregister.nl Identifier: 56264738.

  20. Chlorhexidine Bathing and Healthcare-Associated Infections: A Randomized Clinical Trial

    Science.gov (United States)

    Noto, Michael J.; Domenico, Henry J.; Byrne, Daniel W.; Talbot, Tom; Rice, Todd W.; Bernard, Gordon R.; Wheeler, Arthur P.

    2015-01-01

    Importance Daily bathing of critically ill patients with the broad spectrum, topical antimicrobial agent chlorhexidine is widely performed and may reduce healthcare-associated infections. Objective To determine if daily bathing of critically ill patients with chlorhexidine decreases the incidence of healthcare-associated infections. Design, setting, and participants A pragmatic cluster-randomized, cross-over study of 9,340 patients admitted to five adult intensive care units of a tertiary medical center in Nashville, Tennessee Intervention Units performed once-daily bathing of all patients with disposable cloths impregnated with 2% chlorhexidine or non-antimicrobial cloths as a control. Bathing treatments were performed for a 10-week period followed by a two-week washout period during which patients were bathed with non-antimicrobial disposable cloths, before crossover to the alternate bathing treatment for 10 weeks. Each unit crossed over between bathing assignments three times during the study Main Outcome and Measures The primary prespecified outcome was a composite of central line-associated blood stream infections (CLABSI), catheter-associated urinary tract infections (CAUTI), ventilator-associated pneumonia (VAP), and Clostridium difficile infections. Secondary outcomes included rates of clinical cultures positive for multi-drug resistant organisms, blood culture contamination, healthcare-associated bloodstream infections, and rates of the primary outcome by ICU. Results A total of 55 and 60 infections occurred during chlorhexidine and control bathing periods, respectively (4 and 4 CLABSI, 21 and 32 CAUTI, 17 and 8 VAP, 13 and 16 C. difficile infections, respectively, between chlorhexidine and control bathing periods). The primary outcome rate was 2.86 per 1000 patient-days and 2.90 per 1000 patient-days during chlorhexidine and control bathing periods, respectively (rate difference, −0.04; 95% CI, −1.09 to 1.01; P=0.95). After adjusting for baseline

  1. Fecal microbiota transplant from a rational stool donor improves hepatic encephalopathy: A randomized clinical trial.

    Science.gov (United States)

    Bajaj, Jasmohan S; Kassam, Zain; Fagan, Andrew; Gavis, Edith A; Liu, Eric; Cox, I Jane; Kheradman, Raffi; Heuman, Douglas; Wang, Jessica; Gurry, Thomas; Williams, Roger; Sikaroodi, Masoumeh; Fuchs, Michael; Alm, Eric; John, Binu; Thacker, Leroy R; Riva, Antonio; Smith, Mark; Taylor-Robinson, Simon D; Gillevet, Patrick M

    2017-12-01

    Recurrent hepatic encephalopathy (HE) is a leading cause of readmission despite standard of care (SOC) associated with microbial dysbiosis. Fecal microbiota transplantation (FMT) may improve dysbiosis; however, it has not been studied in HE. We aimed to define whether FMT using a rationally derived stool donor is safe in recurrent HE compared to SOC alone. An open-label, randomized clinical trial with a 5-month follow-up in outpatient men with cirrhosis with recurrent HE on SOC was conducted with 1:1 randomization. FMT-randomized patients received 5 days of broad-spectrum antibiotic pretreatment, then a single FMT enema from the same donor with the optimal microbiota deficient in HE. Follow-up occurred on days 5, 6, 12, 35, and 150 postrandomization. The primary outcome was safety of FMT compared to SOC using FMT-related serious adverse events (SAEs). Secondary outcomes were adverse events, cognition, microbiota, and metabolomic changes. Participants in both arms were similar on all baseline criteria and were followed until study end. FMT with antibiotic pretreatment was well tolerated. Eight (80%) SOC participants had a total of 11 SAEs compared to 2 (20%) FMT participants with SAEs (both FMT unrelated; P = 0.02). Five SOC and no FMT participants developed further HE (P = 0.03). Cognition improved in the FMT, but not the SOC, group. Model for End-Stage Liver Disease (MELD) score transiently worsened postantibiotics, but reverted to baseline post-FMT. Postantibiotics, beneficial taxa, and microbial diversity reduction occurred with Proteobacteria expansion. However, FMT increased diversity and beneficial taxa. SOC microbiota and MELD score remained similar throughout. FMT from a rationally selected donor reduced hospitalizations, improved cognition, and dysbiosis in cirrhosis with recurrent HE. (Hepatology 2017;66:1727-1738). © 2017 by the American Association for the Study of Liver Diseases.

  2. Physical activity for osteoarthritis management: a randomized controlled clinical trial evaluating hydrotherapy or Tai Chi classes.

    Science.gov (United States)

    Fransen, Marlene; Nairn, Lillias; Winstanley, Julie; Lam, Paul; Edmonds, John

    2007-04-15

    To determine whether Tai Chi or hydrotherapy classes for individuals with chronic symptomatic hip or knee osteoarthritis (OA) result in measurable clinical benefits. A randomized controlled trial was conducted among 152 older persons with chronic symptomatic hip or knee OA. Participants were randomly allocated for 12 weeks to hydrotherapy classes (n = 55), Tai Chi classes (n = 56), or a waiting list control group (n = 41). Outcomes were assessed 12 and 24 weeks after randomization and included pain and physical function (Western Ontario and McMaster Universities Osteoarthritis Index), general health status (Medical Outcomes Study Short Form 12 Health Survey [SF-12], version 2), psychological well-being, and physical performance (Up and Go test, 50-foot walk time, timed stair climb). At 12 weeks, compared with controls, participants allocated to hydrotherapy classes demonstrated mean improvements (95% confidence interval) of 6.5 (0.4, 12.7) and 10.5 (3.6, 14.5) for pain and physical function scores (range 0-100), respectively, whereas participants allocated to Tai Chi classes demonstrated improvements of 5.2 (-0.8, 11.1) and 9.7 (2.8, 16.7), respectively. Both class allocations achieved significant improvements in the SF-12 physical component summary score, but only allocation to hydrotherapy achieved significant improvements in the physical performance measures. All significant improvements were sustained at 24 weeks. In this almost exclusively white sample, class attendance was higher for hydrotherapy, with 81% attending at least half of the available 24 classes, compared with 61% for Tai Chi. Access to either hydrotherapy or Tai Chi classes can provide large and sustained improvements in physical function for many older, sedentary individuals with chronic hip or knee OA.

  3. Vitamin E for prevention of oxaliplatin-induced peripheral neuropathy: a pilot randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Samuel Oliveira de Afonseca

    Full Text Available CONTEXT AND OBJECTIVEOxaliplatin is one of the chemotherapy regimens most used for treating colorectal cancer. One of the main limitations to its use is induction of peripheral neuropathy. Previous studies have shown that vitamin E can reduce the incidence of peripheral neuropathy by 50%. This study aimed to assess the effectiveness of vitamin E for prevention of oxaliplatin-induced peripheral neuropathy.DESIGN AND SETTINGProspective, phase II, randomized pilot study developed at a university hospital in the Greater ABC region.METHODSPatients were randomized five days before starting oxaliplatin treatment, to receive either vitamin E or placebo until the end of the chemotherapy regimen. The outcome was evaluated using the Common Terminology Criteria for Adverse Events (CTCAE, version 3, and specific gradation scales for oxaliplatin-induced peripheral neuropathy. Patients with colorectal and gastric cancer who had been scheduled to receive oxaliplatin-based chemotherapy were included. Both groups received calcium and magnesium supplementation before and after oxaliplatin infusions.RESULTSEighteen patients were randomized to the vitamin E group and 16 to the placebo group. Cumulative incidence of 83% with peripheral neuropathy grades 1/2 was observed in the vitamin E group, versus 68% in the placebo group (P = 0.45. A trend towards more diarrhea was observed among patients who received vitamin E (55.6% vs. 18.8%; P = 0.06. There were no other significant differences in toxicity between the groups.CONCLUSIONSNo significant decrease in the incidence of acute oxaliplatin-induced peripheral neuropathy was demonstrated through vitamin E use.CLINICAL TRIAL REGISTRATIONNCT01523574.

  4. Complete supine PCNL: ultrasound vs. fluoroscopic guided: a randomized clinical trial.

    Science.gov (United States)

    Falahatkar, Siavash; Allahkhah, Aliakbar; Kazemzadeh, Majid; Enshaei, Ahmad; Shakiba, Maryam; Moghaddas, Fahimeh

    2016-01-01

    To compare complications and outcomes of complete supine percutaneous nephrolithotomy (csPCNL) with ultrasound guided and fluoroscopically guided procedure. In this randomized clinical trial study from January 2009 to September 2010, 26 of 51 patients with renal stones underwent csPCNL with ultrasonographic guidance in all steps of the procedure (group A), and the other 25 patients underwent standard fluoroscopically guided csPCNL (group B). All of the patients underwent PCNL in the complete supine position. Statistical analysis was performed with SPSS16 software. Mean BMI was 28.14 in group A and 26.31 in group B (p=0.30). The mean stone burden was 26.48 and 30.44 in groups A and B, respectively (p=0.20). The stone free rate was 88.5% in group A and 75.5% in group B, that was no significant (p=0.16). Overall 2 patients (7.7%) in group A and 6 patients (24%) in group B had complications (p=0.11). Mean operative time in group A was 88.46 minutes, and in group B it was 79.58 minutes (p=0.39). Mean hospital stay was 69.70 and 61.79 hours in group A and B, respectively (p=0.22). There was no visceral injury in groups. This randomized study showed that totally ultrasonic had the same outcomes of fluoroscopically csPCNL. Ultrasonography can be an alternative rather than fluoroscopy in PCNL. We believe that more randomized studies are needed to allow endourologists to use sonography rather than fluoroscopy in order to avoid exposition to radiation. Copyright© by the International Brazilian Journal of Urology.

  5. Complete supine PCNL: ultrasound vs. fluoroscopic guided: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Siavash Falahatkar

    Full Text Available ABSTRACT Introduction and Hypothesis: To compare complications and outcomes of complete supine percutaneous nephrolithotomy (csPCNL with ultrasound guided and fluoroscopically guided procedure. Materials and Methods: In this randomized clinical trial study from January 2009 to September 2010, 26 of 51 patients with renal stones underwent csPCNL with ultrasonographic guidance in all steps of the procedure (group A, and the other 25 patients underwent standard fluoroscopically guided csPCNL (group B. All of the patients underwent PCNL in the complete supine position. Statistical analysis was performed with SPSS16 software. Results: Mean BMI was 28.14 in group A and 26.31 in group B (p=0.30. The mean stone burden was 26.48 and 30.44 in groups A and B, respectively (p=0.20. The stone free rate was 88.5% in group A and 75.5% in group B, that was no significant (p=0.16. Overall 2 patients (7.7% in group A and 6 patients (24% in group B had complications (p=0.11. Mean operative time in group A was 88.46 minutes, and in group B it was 79.58 minutes (p=0.39. Mean hospital stay was 69.70 and 61.79 hours in group A and B, respectively (p=0.22. There was no visceral injury in groups. Conclusions: This randomized study showed that totally ultrasonic had the same outcomes of fluoroscopically csPCNL. Ultrasonography can be an alternative rather than fluoroscopy in PCNL. We believe that more randomized studies are needed to allow endourologists to use sonography rather than fluoroscopy in order to avoid exposition to radiation.

  6. Clinical Research and Clinical Trials

    Science.gov (United States)

    ... Contracts section of the NIH website. Find NICHD Clinical Trials NIH maintains the ClinicalTrials.gov website as the main database of publicly and privately funded clinical trials. Each trial has its own pre-defined research ...

  7. Effect of Oral Voriconazole on Fungal Keratitis in the Mycotic Ulcer Treatment Trial II (MUTT II): A Randomized Clinical Trial.

    Science.gov (United States)

    Prajna, N Venkatesh; Krishnan, Tiruvengada; Rajaraman, Revathi; Patel, Sushila; Srinivasan, Muthiah; Das, Manoranjan; Ray, Kathryn J; O'Brien, Kieran S; Oldenburg, Catherine E; McLeod, Stephen D; Zegans, Michael E; Porco, Travis C; Acharya, Nisha R; Lietman, Thomas M; Rose-Nussbaumer, Jennifer

    2016-12-01

    To compare oral voriconazole with placebo in addition to topical antifungals in the treatment of filamentous fungal keratitis. The Mycotic Ulcer Treatment Trial II (MUTT II), a multicenter, double-masked, placebo-controlled, randomized clinical trial, was conducted in India and Nepal, with 2133 individuals screened for inclusion. Patients with smear-positive filamentous fungal ulcers and visual acuity of 20/400 (logMAR 1.3) or worse were randomized to receive oral voriconazole vs oral placebo; all participants received topical antifungal eyedrops. The study was conducted from May 24, 2010, to November 23, 2015. All trial end points were analyzed on an intent-to-treat basis. Study participants were randomized to receive oral voriconazole vs oral placebo; a voriconazole loading dose of 400 mg was administered twice daily for 24 hours, followed by a maintenance dose of 200 mg twice daily for 20 days, with dosing altered to weight based during the trial. All participants received topical voriconazole, 1%, and natamycin, 5%. The primary outcome of the trial was rate of corneal perforation or the need for therapeutic penetrating keratoplasty (TPK) within 3 months. Secondary outcomes included microbiologic cure at 6 days, rate of re-epithelialization, best-corrected visual acuity and infiltrate and/or scar size at 3 weeks and 3 months, and complication rates associated with voriconazole use. A total of 2133 patients in India and Nepal with smear-positive ulcers were screened; of the 787 who were eligible, 240 (30.5%) were enrolled. Of the 119 patients (49.6%) in the oral voriconazole treatment group, 65 were male (54.6%), and the median age was 54 years (interquartile range, 42-62 years). Overall, no difference in the rate of corneal perforation or the need for TPK was determined for oral voriconazole vs placebo (hazard ratio, 0.82; 95% CI, 0.57-1.18; P = .29). In prespecified subgroup analyses comparing treatment effects among organism subgroups, there was some

  8. Randomized clinical trial of the effectiveness of complementary therapies for recurrent aphthous stomatitis.

    Science.gov (United States)

    Rodríguez-Archilla, Alberto; Raissouni, Tarik

    2017-07-21

    Despite the high prevalence of recurrent aphthous stomatitis (RAS), its etiology is not yet completely clear and there is no completely remedial treatment available at present. The objective of this study was to evaluate the clinical efficacy and safety of 4 treatments (silver nitrate, propolis, rhubarb and walnut) for RAS. A randomized clinical trial was conducted with 125 patients with minor aphthae, including 25 patients per group: cauterization with silver nitrate, propolis, rhubarb extract, walnut extract and placebo. No patient reported adverse effects related to the treatment received. There were significant (P<.001) differences in the time elapsed until symptom resolution. The fastest treatment was silver nitrate (1.16 days), followed by the 3 alternative treatments (1.60 days with propolis, 1.84 with rhubarb and 2.00 with walnut; with no differences between them), and finally the placebo (4.64 days). The mean healing time of the lesions was statistically higher (8.96 days) for the placebo than for the 4 treatments: silver nitrate (7.32 days), propolis (6.80), rhubarb (7.72) and walnut (8.00). Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  9. Evaluation of preventive effects of colostrum against neonatal conjunctivitis: A randomized clinical trial.

    Science.gov (United States)

    Ghaemi, Sadigheh; Navaei, Parsa; Rahimirad, Shima; Behjati, Mohaddeseh; Kelishadi, Roya

    2014-01-01

    Neonatal conjunctivitis leads to several ocular consequences in the affected neonates such as blindness. Currently available therapeutic options include NaNO3, Gentamicin, Neomycin and so on, in which each of them has their own limitations. Regarding the immunologic content of colostrum and its safety and easy accessibility, we aimed to evaluate its preventive effects against neonatal conjunctivitis. In this clinical trial, conducted from November 2011 to July 2012, 300 preterm neonates, with culture negative eye swab, were enrolled and randomly assigned into three groups. The intervention group received two drops of colostrum. Control group received no treatment and other neonates were treated with topical Erythromycin ointment (0.5%). All neonates were followed for occurrence of clinical conjunctivitis for 28 days. Data analysis were performed by Chi-square test. Our data demonstrate the beneficial preventive effects of Colostrum against neonatal conjunctivitis (P = 0.036). Colostrum is suggested as an alternative prophylactic option for antibiotics against neonatal conjunctivitis. As colostrum is easily accessible without cost, potential hazards and side effects, public education about its topical favorable effects is worthwhile.

  10. Effect of aromatherapy massage on menopausal symptoms: a randomized placebo-controlled clinical trial.

    Science.gov (United States)

    Darsareh, Fatemeh; Taavoni, Simin; Joolaee, Soodabeh; Haghani, Hamid

    2012-09-01

    Menopause is a significant event in most women's lives because it marks the end of a woman's natural reproductive life. The purpose of this study was to determine the effect of aromatherapy massage on menopausal symptoms. A randomized placebo-controlled clinical trial was conducted at a menopausal clinic at a gynecology hospital in Tehran. The study population comprised 90 women who were assigned to an aromatherapy massage group, a placebo massage group, or a control group. Each participant in the aromatherapy massage group received 30-minute aromatherapy treatment sessions twice a week for 4 weeks with aroma oil, whereas participants in the placebo massage group received the same treatment with plain oil. No treatment was provided to participants in the control group. The outcome measures in this study were menopausal symptoms, as obtained through the Menopause Rating Scale. The mean baseline level of the menopausal score did not differ among all groups. However, after eight sessions of intervention, the Menopause Rating Scale score differed significantly among the three groups (P aromatherapy massage group and the placebo massage group had a lower menopausal score than the control group (P aromatherapy massage and the placebo massage groups were compared, the menopausal score for the aromatherapy massage group was found to be significantly lower (P aromatherapy massage were effective in reducing menopausal symptoms. However, aromatherapy massage was more effective than only massage.

  11. DRY CUPPING IN CHILDREN WITH FUNCTIONAL CONSTIPATION: A RANDOMIZED OPEN LABEL CLINICAL TRIAL.

    Science.gov (United States)

    Shahamat, Mahmoud; Daneshfard, Babak; Najib, Khadijeh-Sadat; Dehghani, Seyed Mohsen; Tafazoli, Vahid; Kasalaei, Afshineh

    2016-01-01

    As a common disease in pediatrics, constipation poses a high burden to the community. In this study, we aimed to investigate the efficacy of dry cupping therapy (an Eastern traditional manipulative therapy) in children with functional constipation. One hundred and twenty children (4-18 years old) diagnosed as functional constipation according to ROME III criteria were assigned to receive a traditional dry cupping protocol on the abdominal wall for 8 minutes every other day or standard laxative therapy (Polyethylene glycol (PEG) 40% solution without electrolyte), 0.4 g/kg once daily) for 4 weeks, in an open label randomized controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 2, 4, 8 and 12 weeks of the intervention commencement in terms of the ROME III criteria for functional constipation. There were no significant differences between the two arms regarding demographic and clinical basic characteristics. After two weeks of the intervention, there was a significant better result in most of the items of ROME III criteria of patients in PEG group. In contrast, after four weeks of the intervention, the result was significantly better in the cupping group. There was no significant difference in the number of patients with constipation after 4 and 8 weeks of the follow-up period. This study showed that dry cupping of the abdominal wall, as a traditional manipulative therapy, can be as effective as standard laxative therapy in children with functional constipation.

  12. Radiofrequency in female external genital cosmetics and sexual function: a randomized clinical trial.

    Science.gov (United States)

    Lordêlo, Patrícia; Leal, Mariana Robatto Dantas; Brasil, Cristina Aires; Santos, Juliana Menezes; Lima, Maria Clara Neves Pavie Cardoso; Sartori, Marair Gracio Ferreira

    2016-11-01

    Female sexual behavior goes through cultural changes constantly, and recently, some women have shown the desire the ideal genitalia. In this study, we aimed to evaluate clinical responses to nonablative radiofrequency (RF) in terms of its cosmetic outcome in the female external genitalia and its effect on sexual function. A single-masking randomized controlled trial was conducted in 43 women (29 sexually active) who were unsatisfied with the appearance of their external genitalia. The women were divided into an RF group (n = 21, 14 sexually active) and a control group (n = 22, 15 sexually active). Eight sessions of RF were performed once a week. Photographs (taken before the first session and 8 days after the last session) were evaluated by the women and three blinded health professionals by using two 3-point Likert scales (unsatisfied, unchanged, and satisfied; and worst, unchanged, and improved). Sexual function was evaluated using the Female Sexual Function Index (FSFI) and analyzed using the Student t test. Women's satisfaction and health professional evaluation were analyzed using the chi-square test and inter- and intragroup binomial comparisons. Satisfaction response rates were 76 and 27 % for the RF and control groups, respectively (p = 0.001). All professionals found a clinical improvement association in the treated group with RF in comparison with the control group (p cosmetic outcome for the female external genitalia, with positives changes in patients' satisfaction and FSFI scores.

  13. Dexmedetomidine premedication for fiberoptic intubation in patients of temporomandibular joint ankylosis: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Kumkum Gupta

    2012-01-01

    Full Text Available Background : Fiberoptic intubation is the gold standard technique for difficult airway management in patients of temporomandibular joint. This study was aimed to evaluate the clinical efficacy and safety of dexmedetomidine as premedication with propofol infusion for fiberoptic intubation. Methods: Consent was obtained from 46 adult patients of temporomandibular joint ankylosis, scheduled for gap arthroplasty. They were enrolled for thisdouble-blind, randomized, prospective clinical trial with two treatment groups - Group D and Group P, of 23 patients each. Group D patients had received premedication of dexmedetomidine 1 μg/kg infused over 10 min followed by sedative propofol infusion and the control Group P patients were given only propofol infusion to achieve sedation. Condition achieved at endoscopy, intubating conditions, hemodynamic changes and postoperative events were evaluated as primary outcome. Results : The fiberoptic intubation was successful with satisfactory endoscopic and intubating condition in all patients. Dexmedetomidine premedication has provided satisfactory conditions for fiberoptic intubation and attenuated the hemodynamic response of fiberoptic intubation than the propofol group. Conclusion : Fiberoptic intubation was found to be easier with dexmedetomidine premedication along with sedative infusion of propofol with complete amnesia of the procedure, hemodynamic stability and preservation of patent airway.

  14. Pimpinella anisum in the treatment of functional dyspepsia: A double-blind, randomized clinical trial

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    S Ashraffodin Ghoshegir

    2015-01-01

    Full Text Available Background: We aimed to evaluate the effects of Pimpinella anisum (anise from Apiaceae family on relieving the symptoms of postprandial distress syndrome (PDS in this double-blind randomized clinical trial. Materials and Methods: Totally, 107 patients attending the gastroenterology clinic, aged 18-65 years, diagnosed with PDS according to ROME III criteria and signed a written consent form were enrolled. They were randomized to receive either anise or placebo, blindly, for 4 weeks. Anise group included 47 patients and received anise powders, 3 g after each meal (3 times/day. Control group involved 60 patients and received placebo powders (corn starch, 3 gafter each meal (3 times/day. The severity of Functional dyspepsia (FD symptoms was assessed by FD severity scale. Assessments were done at baseline and by the end of weeks 2, 4 and 12. Mean scores of severity of FD symptoms and the frequency distribution of patients across the study period were compared. Results: The age, sex, body mass index, smoking history, and coffee drinking pattern of the intervention and control groups were not significantly different. Mean (standard deviation total scores of FD severity scale before intervention in the anise and control groups were 10.6 (4.1 and 10.96 (4.1, respectively (P = 0.6. They were 7.04 (4.1 and 12.30 (4.3 by week 2, respectively (P = 0.0001, 2.44 (4.2 and 13.05 (5.2 by week 4, respectively (P = 0.0001, and 1.08 (3.8 and 13.30 (6.2 by week 12, respectively (P = 0.0001. Conclusion: This study showed the effectiveness of anise in relieving the symptoms of postpartum depression. The findings were consistent across the study period at weeks 2, 4 and 12.

  15. Oral domperidone has no additional effect on chronic functional constipation in children: a randomized clinical trial.

    Science.gov (United States)

    Dehghani, Seyed Mohsen; Askarian, Mehrdad; Kaffashan, Heidar Ali

    2014-03-01

    Chronic constipation represents a common problem in children. The treatment of functional constipation is challenging. Some studies have investigated the effect of prokinetic agents as potential therapies for motility disorders of the lower gastrointestinal tract with paradoxical results. The present study aimed to investigate the effect of oral domperidone in the treatment of chronic functional constipation in children. A total of 105 children with chronic functional constipation (according to Rome III criteria) who were referred to the Pediatric Gastroenterology Clinic were recruited in this double-blind randomized clinical trial. The study subjects were randomly divided into two groups, the first of which received polyethylene glycol (PEG) solution 0.6 g/kg/day two times a day for 6 months and domperidone syrup 0.15 mL/kg three times a day for 3 months (case group) while the second one received PEG with the same dose for 6 months and placebo for 3 months with the same dose (control group). The two groups were compared regarding their symptoms and Rome III criteria through 1, 3, and 6 months following therapy. Primary outcome was response to treatment, and a response was defined as decrease in signs and symptoms that did not fulfill Rome III criteria. Secondary outcome measures were side effects during the course of treatment. A significant difference was observed both before and after PEG and domperidone treatment and before and after PEG and placebo treatment regarding Rome III criteria. There was no significant difference in response to treatment between the two study groups during 1 (p = 1), 3 (p = 0.799), and 6 (p = 0.403) month follow up periods. Also, the two groups were not significantly different regarding the Rome III criteria during the mentioned follow up periods. There were no side effects during the course of treatment. There was no additional effect of domperidone as adjunct to PEG in the treatment of children with constipation.

  16. Effects of Myofascial Release in Non-specific Chronic Low Back Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Arguisuelas, Maria Dolores; Lisón, Juan Francisco; Sánchez-Zuriaga, Daniel; Martínez-Hurtado, Isabel; Doménech-Fernández, Julio

    2016-09-09

    Double-blind, randomized parallel sham-controlled trial with concealed allocation and intention-to treat analysis. To investigate the effects of an isolate Myofascial Release protocol (MFR) on pain, disability and fear- avoidance beliefs in patients with chronic low back pain (CLBP). MFR is a form of manual medicine widely used by physiotherapists in the management of different musculoskeletal pathologies. Up to this moment, no previous studies have reported the effects of an isolated MFR treatment in patients with CLBP. Fifty four participants, with nonspecific CLBP, were randomized to MFR group (n = 27) receiving four sessions of myofascial treatment, each lasting 40 minutes, and to control group (n = 27) receiving a sham MFR. Variables studied were pain measured by means Short Form McGill Pain questionnaire (SF-MPQ) and visual analogue scale (VAS), disability measured with Roland Morris questionnaire and Fear-Avoidance Beliefs measured with FAB questionnaire (FABQ). Subjects receiving MFR displayed significant improvements in pain (SF-MPQ) (mean difference -7.8; 95% CI: -14.5 to -1.1, P = 0.023) and sensory SF-MPQ subscale (mean difference -6.1; 95% CI: -10.8 to -1.5, P = 0.011) compared to the sham group, but no differences were found in VAS between groups. Disability and the FABQ score also displayed a significant decrease in the MFR group (P Myofascial Release Therapy produced a significant improvement in both pain and disability. However, as the minimal clinically important differences in pain and disability are included in the 95% IC, we can not know if this improvement is clinically relevant. 2.

  17. Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Arguisuelas, María D; Lisón, Juan Francisco; Sánchez-Zuriaga, Daniel; Martínez-Hurtado, Isabel; Doménech-Fernández, Julio

    2017-05-01

    Double-blind, randomized parallel sham-controlled trial with concealed allocation and intention-to treat analysis. To investigate the effects of an isolate myofascial release (MFR) protocol on pain, disability, and fear-avoidance beliefs in patients with chronic low back pain (CLBP). MFR is a form of manual medicine widely used by physiotherapists in the management of different musculoskeletal pathologies. Up to this moment, no previous studies have reported the effects of an isolated MFR treatment in patients with CLBP. Fifty-four participants, with nonspecific CLBP, were randomized to MFR group (n = 27) receiving four sessions of myofascial treatment, each lasting 40 minutes, and to control group (n = 27) receiving a sham MFR. Variables studied were pain measured by means Short Form McGill Pain Questionnaire (SF-MPQ) and visual analog scale (VAS), disability measured with Roland Morris Questionnaire, and fear-avoidance beliefs measured with Fear-Avoidance Beliefs Questionnaire. Subjects receiving MFR displayed significant improvements in pain (SF-MPQ) (mean difference -7.8; 95% confidence interval [CI]: -14.5 to -1.1, P = 0.023) and sensory SF-MPQ subscale (mean difference -6.1; 95% CI: -10.8 to -1.5, P = 0.011) compared to the sham group, but no differences were found in VAS between groups. Disability and the Fear-Avoidance Beliefs Questionnaire score also displayed a significant decrease in the MFR group (P < 0.05) as compared to sham MFR. MFR therapy produced a significant improvement in both pain and disability. Because the minimal clinically important differences in pain and disability are, however, included in the 95% CI, we cannot know whether this improvement is clinically relevant. 2.

  18. Nebulized fentanyl vs intravenous morphine for ED patients with acute limb pain: a randomized clinical trial.

    Science.gov (United States)

    Farahmand, Shervin; Shiralizadeh, Said; Talebian, Mohammad-Taghi; Bagheri-Hariri, Shahram; Arbab, Mona; Basirghafouri, Hamed; Saeedi, Morteza; Sedaghat, Mojtaba; Mirzababai, Habibolla

    2014-09-01

    Intravenous morphine has been used as a common method of pain control in emergency care. Nebulized fentanyl is also an effective temporary substitute. This study was designed to compare the effectiveness of nebulized fentanyl with intravenous (IV) morphine on management of acute limb pain. This was a placebo-controlled, double-blind randomized clinical trial. Ninety emergency department patients with moderate to severe pain aged 15 to 50 years were blocked randomized and enrolled in this study. Forty-seven patients in the experimental group received nebulized fentanyl (4 μg/kg) and IV normal saline as placebo, and the remaining 43 patients in the control group received IV morphine (0.1 mg/kg) and nebulized normal saline as placebo. All participants' pain scores were assessed by Numerical Rating Scale before and after intervention at 5-, 10-, 15-, 30-, 45-, and 60-minute intervals. Patients' vital sign and possible adverse effects were recorded respectively. Finally, all participants were assessed for their satisfaction. The mean initial pain score in the experimental group was 8.7 and 8.4 in the control group (P = .1). Pain relief in both groups after 5 and 10 minutes were similar (P = .72). Although the pain relief was significantly greater with fentanyl at 15 minutes, this difference is not clinically significant. Pain management in both groups was successful and was more than 3 scores reduction in Numerical Rating Scale. Patient satisfaction in both groups was similar. No adverse effects were reported in the experimental group. This study suggests that nebulized fentanyl is a rapid, safe, and effective method for temporary control of acute limb pain in emergency department patients. Copyright © 2014 Elsevier Inc. All rights reserved.

  19. Assessment of chemomechanical removal of carious lesions using Papacarie Duo ™: Randomized longitudinal clinical trial

    Directory of Open Access Journals (Sweden)

    Simone Ferreira Borges Matsumoto

    2013-01-01

    Full Text Available Background: Chemomechanical removal of carious lesions consists of the dissolution of carious tissue by the application of a natural or synthetic agent, followed by atraumatic mechanical removal. Aim: The aim of the present study was to assess the effectiveness of Papacarie Duo ® gel in the chemomechanical removal of carious lesions in primary teeth in comparison to the traditional method (low-speed bur. Settings and Design: A randomized clinical trial was conducted with 20 children between 5 and 8 years of age. Materials and Methods: Two teeth were treated in each child (split-mouth design, with the randomization of two methods: Group 1 - chemomechanical caries removal with Papacarie Duo™; and Group 2 - removal of carious dentin tissue using a low-speed bur. Both methods involved restoration with glass ionomer cement and follow up. The following aspects were evaluated: time required for the procedure; pain (face evaluation scale; rtention of the restorative material in the cavity; and the presence of secondary caries after 30 days. Statistical Analysis Used: Chi-squared test, Student′s t-test, and Wilcoxon test. Results: No statistically significant differences between methods were found regarding time required for the procedure (P = 0.13, the occurrence of pain (P = 0.585, or restoration status at the 30-day clinical evaluation (P = 0.713. Conclusion: The findings of the present study demonstrate that the two methods achieve similar results. The advantages of minimally invasive treatment, such as chemomechanical caries removal with Papacarie Duo™, are its ease of use, patient comfort, and the fact that it causes less damage to dental tissue.

  20. Handheld vs. laptop computers for electronic data collection in clinical research: a crossover randomized trial.

    Science.gov (United States)

    Haller, Guy; Haller, Dagmar M; Courvoisier, Delphine S; Lovis, Christian

    2009-01-01

    To compare users' speed, number of entry errors and satisfaction in using two current devices for electronic data collection in clinical research: handheld and laptop computers. The authors performed a randomized cross-over trial using 160 different paper-based questionnaires and representing altogether 45,440 variables. Four data coders were instructed to record, according to a random predefined and equally balanced sequence, the content of these questionnaires either on a laptop or on a handheld computer. Instructions on the kind of device to be used were provided to data-coders in individual sealed and opaque envelopes. Study conditions were controlled and the data entry process performed in a quiet environment. The authors compared the duration of the data recording process, the number of errors and users' satisfaction with the two devices. The authors divided errors into two separate categories, typing and missing data errors. The original paper-based questionnaire was used as a gold-standard. The overall duration of the recording process was significantly reduced (2.0 versus 3.3 min) when data were recorded on the laptop computer (p laptop compared to 8.4 per 1,000 with the handheld computer (p laptop was used (p laptop easier, faster and more satisfying to use than the handheld computer. Despite the increasing use of handheld computers for electronic data collection in clinical research, these devices should be used with caution. They double the duration of the data entry process and significantly increase the risk of typing errors and missing data. This may become a particularly crucial issue in studies where these devices are provided to patients or healthcare workers, unfamiliar with computer technologies, for self-reporting or research data collection processes.

  1. A Collaborative Paradigm for Improving Management of Sleep Disorders in Primary Care: A Randomized Clinical Trial.

    Science.gov (United States)

    Edinger, Jack D; Grubber, Janet; Ulmer, Christi; Zervakis, Jennifer; Olsen, Maren

    2016-01-01

    To test a collaborative care model for interfacing sleep specialists with primary care providers to enhance patients' sleep disorders management. This study used a randomized, parallel group, clinical intervention trial design. A total of 137 adult (29 women) VA outpatients with sleep complaints were enrolled and randomly assigned to (1) an intervention (INT) consisting of a one-time consultation with a sleep specialist who provided diagnostic feedback and treatment recommendations to the patient and the patient's primary care provider; or (2) a control condition consisting of their usual primary care (UPC). Provider-focused outcomes included rates of adherence to recommended diagnostic procedures and sleep-focused interventions. Patient-focused outcomes included measures taken from sleep diaries and actigraphy; Pittsburgh Sleep Quality Index (PSQI) scores; and self-report measures of sleepiness, fatigue, mood, quality of life, and satisfaction with health care. The proportions of provider-initiated sleep-focused interventions were significantly higher in the INT group than in the UPC group for polysomnography referrals (49% versus 6%; P sleep efficiency (+3.7%; 95% CI: 0.8, 6.5; P = 0.01) than did UPC participants. A greater proportion of the INT group showed ≥ 1 standard deviation decline on the PSQI from baseline to the 10-mo follow-up (41% versus 21%; P = 0.02). Moreover, 69% of the INT group had normal (≤ 10) Epworth Sleepiness Scale scores at the 10-mo follow-up, whereas only 50% of the UPC group fell below this clinical cutoff (P = 0.03). A one-time sleep consultation significantly increased healthcare providers' attention to sleep problems and resulted in benefits to patients' sleep/wake symptoms. This study is registered with clinicaltrials.gov with identifier # NCT00390572. © 2016 Associated Professional Sleep Societies, LLC.

  2. Angioplasty Guided by Intravascular Ultrasound: Meta-Analysis of Randomized Clinical Trials

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    Figueiredo, José Albuquerque Neto de, E-mail: jafneto@cardiol.br; Nogueira, Iara Antonia Lustosa [Universidade Federal do Maranhão, São Luiz, MA (Brazil); Figueiro, Mabel Fernandes; Buehler, Anna Maria; Berwanger, Otavio [Instituto de Ensino e Pesquisa do Hospital do Coração, São Paulo, SP (Brazil)

    2013-08-15

    The impact of intravascular ultrasound (IVUS) use on stenting has shown inconclusive results. Systematic review and meta-analysis of the impact of IVUS on stenting regarding the clinical and angiographic evolution. A search was performed in Medline/Pubmed, CENTRAL, Embase, Lilacs, Scopus and Web of Science databases. It included randomized clinical trials (RCTs) that evaluated the implantation of stents guided by IVUS, compared with those using angiography alone (ANGIO). The minimum follow-up duration was six months and the following outcomes were assessed: thrombosis, mortality, myocardial infarction, percutaneous and surgical revascularization, major adverse cardiovascular events (MACE) and restenosis. The binary outcomes were presented considering the number of events in each group; the estimates were generated by a random effects model, considering Mantel-Haenszel statistics as weighting agent and magnitude of effect for the relative risk (RR) with its respective 95% confidence interval (95%CI). Higgins I{sup 2} test was used to quantify the consistency between the results of each study. A total of 2,689 articles were evaluated, including 8 RCTs. There was a 27% reduction in angiographic restenosis (RR: 0.73, 95% CI: 0.54-0.97, I{sup 2} = 51%) and statistically significant reduction in the rates of percutaneous revascularization and overall (RR: 0.88; 95% CI: 0.51 to 1.53, I{sup 2} = 61%, RR: 0.73, 95% CI: 0.54 to 0.99, I{sup 2} = 55%), with no statistical difference in surgical revascularization (RR: 0.95, 95% CI: 0.52-1.74, I{sup 2} = 0%) in favor of IVUS vs. ANGIO. There were no differences regarding the other outcomes in the comparison between the two strategies. Angioplasty with stenting guided by IVUS decreases the rates of restenosis and revascularization, with no impact on MACE, acute myocardial infarction, mortality or thrombosis outcomes.

  3. Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial.

    Science.gov (United States)

    Amrutesh, Sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

    2010-01-01

    The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hygiene status, bleeding index, and gingival index was evaluated in these patients along with microbiological study. Results indicated a significant reduction in plaque index, gingival index, oral hygiene index, and microbial growth in both groups. Difference between the groups was not significant. There was no significant change in bleeding index. No adverse events were reported and both the dental creams were well tolerated. The finding of this preliminary study indicates that herbal dental cream is as safe and effective as fluoride dental cream, but not superior to it.

  4. Patient recruitment into a multicenter randomized clinical trial for kidney disease: report of the focal segmental glomerulosclerosis clinical trial (FSGS CT).

    Science.gov (United States)

    Ferris, Maria; Norwood, Victoria; Radeva, Milena; Gassman, Jennifer J; Al-Uzri, Amira; Askenazi, David; Matoo, Tej; Pinsk, Maury; Sharma, Amita; Smoyer, William; Stults, Jenna; Vyas, Shefali; Weiss, Robert; Gipson, Debbie; Kaskel, Frederick; Friedman, Aaron; Moxey-Mims, Marva; Trachtman, Howard

    2013-02-01

    We describe the experience of the focal segmental glomerulosclerosis clinical trial (FSGS CT) in the identification and recruitment of participants into the study. This National Institutes of Health funded study, a multicenter, open-label, randomized comparison of cyclosporine versus oral dexamethasone pulses plus mycophenolate mofetil, experienced difficulty and delays meeting enrollment goals. These problems occurred despite the support of patient advocacy groups and aggressive recruitment strategies. Multiple barriers were identified including: (1) inaccurate estimates of the number of potential incident FSGS patients at participating centers; (2) delays in securing one of the test agents; (3) prolonged time between IRB approval and execution of a subcontract (mean 7.5 ± 0.8 months); (4) prolonged time between IRB approval and enrollment of the first patient at participating sites (mean 19.6 ± 1.4 months); and (5) reorganization of clinical coordinating core infrastructure to align resources with enrollment. A Web-based anonymous survey of site investigators revealed site-related barriers to patient recruitment. The value of a variety of recruitment tools was of marginal utility in facilitating patient enrollment. We conclude that improvements in the logistics of study approval and regulatory start-up and testing of promising novel agents are important factors in promoting enrollment into randomized clinical trials in nephrology. © 2013 Wiley Periodicals, Inc.

  5. Benson's Relaxation Effect in Comparing to Systematic Desensitization on Anxiety of Female Nurses: A Randomized Clinical Trial

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    Sajadi, Mahbobeh; Goudarzi, Khatereh; Khosravi, Sharareh; Farmahini-Farahani, Molod; Mohammadbeig, Abolfazl

    2017-01-01

    Introduction: Nursing staffs expose to a high level of anxiety. This study aimed to compare the effect of Benson's relaxation and systematic desensitization methods for decreasing the anxiety score of nurses. Materials and Methods: In a randomized clinical trial, 72 female nurses were assigned randomly to three different groups. Benson's relaxation and systematic desensitization were used as intervention beside control group. After intervention, the Spielberger state-trait anxiety inventory w...

  6. Early loading of plalatal implants (ortho-type II a prospective multicenter randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Gedrange Tomasz

    2007-09-01

    Full Text Available Abstract Background In orthodontic treatment, anchorage control is a fundamental aspect. Usually conventional mechanism for orthodontic anchorage control can be either extraoral or intraoral that is headgear or intermaxillary elastics. Their use are combined with various side effects such as tipping of occlusal plane or undesirable movements of teeth. Especially in cases, where key-teeth are missing, conventional anchorage defined as tooth-borne anchorage will meet limitations. Therefore, the use of endosseous implants for anchorage purposes are increasingly used to achieve positional stability and maximum anchorage. Methods/Design The intended study is designed as a prospective, multicenter randomized controlled trial (RCT, comparing and contrasting the effect of early loading of palatal implant therapy versus implant loading after 12 weeks post implantation using the new ortho-implant type II anchor system device (Orthosystem Straumann, Basel, Switzerland. 124 participants, mainly adult males or females, whose diagnoses require temporary stationary implant-based anchorage treatment will be randomized 1:1 to one of two treatment groups: group 1 will receive a loading of implant standard therapy after a healing period of 12 week (gold standard, whereas group 2 will receive an early loading of orthodontic implants within 1 week after implant insertion. Participants will be at least followed for 12 months after implant placement. The primary endpoint is to investigate the behavior of early loaded palatal implants in order to find out if shorter healing periods might be justified to accelerate active orthodontic treatment. Secondary outcomes will focus e.g. on achievement of orthodontic treatment goals and quantity of direct implant-bone interface of removed bone specimens. As tertiary objective, a histologic and microtomography evaluation of all retrieved implants will be performed to obtain data on the performance of the SLA surface in human bone

  7. Effect of fluconazole prophylaxis on candidiasis and mortality in premature infants: A randomized clinical trial

    Science.gov (United States)

    Benjamin, Daniel K.; Hudak, Mark L.; Duara, Shahnaz; Randolph, David A.; Bidegain, Margarita; Mundakel, Gratias T.; Natarajan, Girija; Burchfield, David J.; White, Robert D.; Shattuck, Karen E.; Neu, Natalie; Bendel, Catherine M.; Kim, M. Roger; Finer, Neil N.; Stewart, Dan L.; Arrieta, Antonio C.; Wade, Kelly C.; Kaufman, David A.; Manzoni, Paolo; Prather, Kristi O.; Testoni, Daniela; Berezny, Katherine Y.; Smith, P. Brian

    2014-01-01

    IMPORTANCE Invasive candidiasis in premature infants causes mortality and neurodevelopmental impairment. Fluconazole prophylaxis reduces candidiasis, but its effect on mortality and the safety of fluconazole is unknown. OBJECTIVE To evaluate the efficacy and safety of fluconazole in preventing death or invasive candidiasis in extremely low-birth-weight infants. DESIGN, SETTING, AND PATIENTS This study was a randomized, blinded, placebo-controlled trial of fluconazole in premature infants. Infants weighing less than 750 g at birth (N = 361) from 32 neonatal intensive care units (NICUs) in the United States were randomly assigned to receive either fluconazole or placebo twice weekly for 42 days. Surviving infants were evaluated at 18 to 22 months corrected age for neurodevelopmental outcomes. The study was conducted between November 2008 and February 2013. INTERVENTIONS Fluconazole (6 mg/kg of body weight) or placebo. MAIN OUTCOMES AND MEASURES The primary end point was a composite of death or definite or probable invasive candidiasis prior to study day 49 (1 week after completion of study drug). Secondary and safety outcomes included invasive candidiasis, liver function, bacterial infection, length of stay, intracranial hemorrhage, periventricular leukomalacia, chronic lung disease, patent ductus arteriosus requiring surgery, retinopathy of prematurity requiring surgery, necrotizing enterocolitis, spontaneous intestinal perforation, and neurodevelopmental outcomes—defined as a Bayley-III cognition composite score of less than 70, blindness, deafness, or cerebral palsy at 18–22-months corrected age. RESULTS Among infants receiving fluconazole, the composite primary end point of death or invasive candidiasis was 16% (95% CI, 11%–22%) vs 21% in the placebo group (95% CI, 15%–28%; odds ratio 0.73 [95% CI 0.43–1.23]; P=.24; treatment difference −5% [95% CI, −13%–3%]). Invasive candidiasis occurred less frequently in the fluconazole group (3% [95% CI, 1%

  8. Tools for teen moms to reduce infant obesity: a randomized clinical trial.

    Science.gov (United States)

    Horodynski, Mildred A; Silk, Kami; Hsieh, Gary; Hoffman, Alice; Robson, Mackenzie

    2015-01-21

    Unhealthy infant feeding practices, such as a combination of formula feeding and early introduction of solids may lead to rapid or excessive weight gain in early infancy. Adolescent mothers' feeding behaviors are most directly related to infant weight gain in the first year of life. Compared to adult mothers, adolescent mothers are less knowledgeable, less responsive, more controlling, and less skilled in infant feeding, which interferes with infants' healthy growth. The Tools for Teen Moms trial aims to compare the effect of a social media intervention for low-income adolescent, first-time mothers of infants 2 months of age or younger, versus standard care on infant weight, maternal responsiveness, and feeding style and practices. The intervention is conducted during the infant's first four months of life to promote healthy transition to solids during their first year. Tools for Teen Moms is an intervention delivered via a social media platform that actively engages and coaches low-income adolescent mothers in infant-centered feeding to reduce rapid/excessive infant weight gain in the first six months of life. We describe our study protocol for a randomized control trial with an anticipated sample of 100 low-income African- American and Caucasian adolescent, first-time mothers of infants. Participants are recruited through Maternal-Infant Health Programs in four counties in Michigan, USA. Participants are randomly assigned to the intervention or the control group. The intervention provides infant feeding information to mothers via a web-based application, and includes daily behavioral challenges, text message reminders, discussion forums, and website information as a comprehensive social media strategy over 6 weeks. Participants continue to receive usual care during the intervention. Main maternal outcomes include: (a) maternal responsiveness, (b) feeding style, and (c) feeding practices. The primary infant outcome is infant weight. Data collection occurs at

  9. Effects of Normobaric Hyperoxia in Severe Acute Stroke: a Randomized Controlled Clinical Trial Study.

    Science.gov (United States)

    Mazdeh, Mehrdokht; Taher, Abbas; Torabian, Saadat; Seifirad, Soroush

    2015-11-01

    Oxygen therapy might increase damaged tissue oxygenation, turn on the aerobic pathway, and save neurons from death and could improve clinical outcome of the patients with stroke and head trauma. Hyperbaric oxygen therapy is accompanied by some unfavorable effects. Results of normobaric oxygen therapy on clinical outcomes of patients with stroke were controversial up till now.  This study was therefore designed to evaluate effects of normobaric hyperoxia on clinical outcomes of patients with severe acute stroke. A total of 52 consecutive patients with stroke who meet the inclusion criteria of the study were entered into this randomized controlled clinical trial. The patients in the case group underwent oxygen therapy with Venturi mask for first 12 hours of admission. The patients were examined for neurologic defects at the time of discharge and after six months using both Barthel and modified Rankin Scale (mRS) neurologic disability scoring systems. There was no significant sex difference between the two groups (P=0.5). There was no statistically significant difference between ischemic-hemorrhagic stroke constitutions of two groups (P=0.2). There were no significant difference in Barthel index scores of both groups at the time of discharge as well as the follow-up examination (P=0.7) According to the mRS scoring system, there was no difference between the patients of both groups at the time of admission (P= 0.8), however after treatment there was a significant difference between mRS scores of the treated group compared to the controls (P=0.04). According to the results of this study, normobaric oxygen therapy in the first 12 hours of accident could improve long time outcome of the patients with either ischemic or hemorrhagic stroke.

  10. A randomized clinical trial of chiropractic treatment and self-management in patients with acute musculoskeletal chest pain

    DEFF Research Database (Denmark)

    Stochkendahl, Mette J; Christensen, Henrik W; Vach, Werner

    2012-01-01

    We have previously reported short-term follow-up from a pragmatic randomized clinical trial comparing 2 treatments for acute musculoskeletal chest pain: (1) chiropractic treatment and (2) self-management. Results indicated a positive effect in favor of the chiropractic treatment after 4 and 12...

  11. Therapist-rated outcomes in a randomized clinical trial comparing cognitive behavioral therapy and psychodynamic therapy for major depression

    NARCIS (Netherlands)

    Driessen, E.; Van, H.L.; Peen, J.; Don, F.J.; Kool, S.; Westra, D.; Hendriksen, M.; Cuijpers, P.; Twisk, J.W.R.; Dekker, J.J.M.

    2015-01-01

    Background The efficacy of psychodynamic therapy (PDT) for depression is debated due to a paucity of high-quality studies. We compared short psychodynamic supportive psychotherapy (SPSP) to cognitive behavioral therapy (CBT) in a randomized clinical trial. We used therapist-rated outcomes to examine

  12. A Randomized Clinical Trial of Multisystemic Therapy with Juvenile Sexual Offenders: Effects on Youth Social Ecology and Criminal Activity

    Science.gov (United States)

    Borduin, Charles M.; Schaeffer, Cindy M.; Heiblum, Naamith

    2009-01-01

    A randomized clinical trial evaluated the efficacy of multisystemic therapy (MST) versus usual community services (UCS) for 48 juvenile sexual offenders at high risk of committing additional serious crimes. Results from multiagent assessment batteries conducted before and after treatment showed that MST was more effective than UCS in improving key…

  13. Comparison between conventional and piezoelectric surgical tools for maxillary sinus floor elevation : a randomized controlled clinical trial

    NARCIS (Netherlands)

    Rickert, Daniela; Vissink, Arjan; Huddleston Slater, James; Meijer, Henny J. A.; Raghoebar, Gerry M.

    Aim: The aim of this study was to assess the performance of conventional rotative instruments and a piezoelectric device for maxillary sinus floor elevation surgery, and to assess whether application of a resorbable membrane reduces resorption of an augmented site in a randomized clinical trial.

  14. Randomized Clinical Trial of Indirect Resin Composite and Ceramic Veneers : Up to 3-year Follow-up

    NARCIS (Netherlands)

    Gresnigt, Marco M. M.; Kalk, Warner; Ozcan, Mutlu

    2013-01-01

    Purpose: This randomized controlled split-mouth clinical trial evaluated the short-term survival rate of indirect resin composite and ceramic laminate veneers. Materials and Methods: A total of 10 patients (mean age: 48.6 years) received 46 indirect resin composite (Estenia; n = 23) and ceramic

  15. A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy

    Science.gov (United States)

    Kerson, Cynthia

    2013-01-01

    Objective: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large…

  16. Under-reporting of venous and arterial thrombotic events in randomized clinical trials: a meta-analysis

    NARCIS (Netherlands)

    Stuijver, Danka J. F.; Romualdi, Erica; van Zaane, Bregje; Bax, Leon; Büller, Harry R.; Gerdes, Victor E. A.; Squizzato, Alessandro

    2015-01-01

    For the detection of unwanted outcomes of new interventions, physicians rely on adverse event reporting. We attempt to quantify the reported incidence of venous thromboembolism (VTE) and arterial thrombosis (AT) in randomized clinical trials (RCTs), and evaluate the extent of under-reporting. We

  17. Cognitive Behavioral Treatment of PTSD in Residents of Battered Women's Shelters: Results of a Randomized Clinical Trial

    Science.gov (United States)

    Johnson, Dawn M.; Zlotnick, Caron; Perez, Sara

    2011-01-01

    Objective: This study was designed to explore the acceptability, feasibility, and initial efficacy of a new shelter-based treatment for victims of intimate partner violence (IPV; i.e., Helping to Overcome PTSD through Empowerment [HOPE]). Method: A Phase I randomized clinical trial comparing HOPE (n = 35) with standard shelter services (SSS) (n =…

  18. A Multicenter, Randomized Clinical Trial of a Cognitive Remediation Program for Childhood Survivors of a Pediatric Malignancy

    Science.gov (United States)

    Butler, Robert W.; Copeland, Donna R.; Fairclough, Diane L.; Mulhern, Raymond K.; Katz, Ernest R.; Kazak, Anne E.; Noll, Robert B.; Patel, Sunita K.; Sahler, Olle Jane Z.

    2008-01-01

    Survivors of childhood cancer whose malignancy and/or treatment involved the central nervous system may demonstrate a consistent pattern of neurocognitive deficits. The present study evaluated a randomized clinical trial of the Cognitive Remediation Program (CRP). Participants were 6- to 17-year-old survivors of childhood cancer (N = 161; 35%…

  19. Language skills of young children with unilateral cleft lip and palate following infant orthopedics: a randomized clinical trial.

    NARCIS (Netherlands)

    Konst, E.M.; Rietveld, T.; Peters, H.F.M.; Kuijpers-Jagtman, A.M.

    2003-01-01

    OBJECTIVE: To investigate the effects of infant orthopedics (IO) on the language skills of children with complete unilateral cleft lip and palate (UCLP). DESIGN: In a prospective randomized clinical trial (Dutchcleft), two groups of children with complete UCLP were followed up longitudinally: one

  20. A Randomized Clinical Trial of Methadone Maintenance for Prisoners: Prediction of Treatment Entry and Completion in Prison

    Science.gov (United States)

    Gordon, Michael S.; Kinlock, Timothy W.; Couvillion, Kathryn A.; Schwartz, Robert P.; O'Grady, Kevin

    2012-01-01

    The present report is an intent-to-treat analysis involving secondary data drawn from the first randomized clinical trial of prison-initiated methadone in the United States. This study examined predictors of treatment entry and completion in prison. A sample of 211 adult male prerelease inmates with preincarceration heroin dependence were randomly…

  1. Threshold electrical stimulation (TES) in ambulant children with CP: a randomized double-blind placebo-controlled clinical trial

    DEFF Research Database (Denmark)

    Dali, Christine í; Hansen, Flemming Juul; Pedersen, Søren Anker

    2002-01-01

    A randomized double-blind placebo-controlled clinical trial was carried out to determine whether a group of stable children with cerebral palsy (36 males, 21 females; mean age 10 years 11 months, range 5 to 18 years) would improve their motor skills after 12 months of threshold electrical...

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

    NARCIS (Netherlands)

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

    2011-01-01

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

  3. The effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a randomized clinical trial.

    NARCIS (Netherlands)

    Baar, M.E. van; Dekker, J.; Oostendorp, R.A.B.; Bijl, D.; Voorn, T.B.; Lemmens, J.A.M.; Bijlsma, J.W.J.

    1998-01-01

    Objective: To determine the effectiveness of exercise therapy in patients with osteoarthritis (OA) of the hip or knee. Methods: A randomized single blind, clinical trial was conducted in a primary care setting. Patients with hip or knee OA by American College of Rheumatology criteria were

  4. Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II

    NARCIS (Netherlands)

    Versyck, B.; Geffen, G.J. van; Houwe, P. Van

    2017-01-01

    STUDY OBJECTIVE: The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. DESIGN: A prospective randomized double blind placebo-controlled study. SETTING:

  5. Sealing versus partial caries removal in primary molars: a randomized clinical trial

    National Research Council Canada - National Science Library

    Hesse, D; Bonifácio, C.C; Mendes, F.M; Braga, M.M; Imparato, J.C.P; Raggio, D.P

    2014-01-01

    .... The aim of this clinical trial is to verify the efficacy of pit and fissure sealants in arresting dentinal caries lesions compared to partial excavation and restorative treatment in primary molar teeth...

  6. Coronary revascularization in ischemic heart disease: lessons from observational studies and randomized clinical trials

    NARCIS (Netherlands)

    N.F. Mercado (Nestor)

    2003-01-01

    textabstractThis thesis presents an overview of clinical trials and observational studies on coronary revascularization and evaluates the results obtained with revascularization in different subsets of patients treated with percutaneous coronary intervention or coronary artery bypass

  7. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial

    OpenAIRE

    Goodman, Phyllis J.; Tangen, Catherine M.; Darke, Amy K.; Arnold, Kathryn B.; Hartline, JoAnn; Yee, Monica; Anderson, Karen; Caban-Holt, Allison; Christen, William G.; Patricia A Cassano; Lance, Peter; Eric A Klein; Crowley, John J.; Minasian, Lori M.; Meyskens, Frank L

    2016-01-01

    Background: The Selenium and Vitamin E Cancer Prevention Trial (SELECT) was a randomized, double-blind, placebo-controlled, prostate cancer prevention study funded by the National Cancer Institute and conducted by SWOG (Southwest Oncology Group). A total of 35,533 men were assigned randomly to one of four treatment groups (vitamin E + placebo, selenium + placebo, vitamin E + selenium, placebo + placebo). At the time of the trial’s development, NIH had invested substantial resources in evaluat...

  8. The treatment of medial tibial stress syndrome in athletes; a randomized clinical trial

    OpenAIRE

    Moen, Maarten Hendrik; Holtslag, Leonoor; Bakker, Eric; Barten, Carl; Weir, Adam; Tol, Johannes L; Backx, Frank

    2012-01-01

    Abstract Background The only three randomized trials on the treatment of MTSS were all performed in military populations. The treatment options investigated in this study were not previously examined in athletes. This study investigated if functional outcome of three common treatment options for medial tibial stress syndrome (MTSS) in athletes in a non-military setting was the same. Methods The study design was randomized and multi-centered. Physical therapists and sports physicians referred ...

  9. Randomized Clinical Trial of Online Parent Training for Behavior Problems After Early Brain Injury.

    Science.gov (United States)

    Wade, Shari L; Cassedy, Amy E; Shultz, Emily L; Zang, Huaiyu; Zhang, Nanhua; Kirkwood, Michael W; Stancin, Terry; Yeates, Keith O; Taylor, H Gerry

    2017-11-01

    To evaluate the effectiveness of Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT) versus abbreviated parent training (Express) or access to online resources (internet resources comparison [IRC]) in improving parenting skills and decreasing behavior problems after early traumatic brain injury (TBI). In this randomized, controlled, clinical trial, 113 children 3 to 9 years old previously hospitalized for moderate to severe TBI were randomly assigned to receive Express (n = 36), I-InTERACT (n = 39), or IRC (n = 38). Express included 7 online parent skills sessions, and I-InTERACT delivered 10 to 14 sessions addressing parenting skills, TBI education, stress, and anger management. The 2 interventions coupled online modules with therapist coaching through a Health Insurance Portability and Accountability Act-compliant Skype link. The IRC group received access to online TBI and parent skills resources. Co-primary outcomes were blinded ratings of parenting skills and parent report of behavior problems and problem intensity on the Eyberg Child Behavior Inventory (ECBI). Outcomes were assessed before treatment and 3 and 6 months after treatment, with the latter constituting the primary endpoint. The Express and I-InTERACT groups displayed higher levels of positive parenting at follow-up. Only the I-InTERACT group had lower levels of negative parenting at 6 months. The Express group had lower ECBI intensity scores than the IRC group. Baseline symptom levels moderated improvements; children in the Express and I-InTERACT groups with higher baseline symptoms demonstrated greater improvements than those in the IRC group. Changes in parenting skills mediated improvements in behavior in those with higher baseline symptoms. Brief online parent skills training can effectively decrease behavior problems after early TBI in children with existing behavioral symptoms. Clinical trial registration information-Internet-based Interacting Together

  10. Melatonin Supplementation for Children With Atopic Dermatitis and Sleep Disturbance: A Randomized Clinical Trial.

    Science.gov (United States)

    Chang, Yung-Sen; Lin, Ming-Hung; Lee, Jyh-Hong; Lee, Pei-Lin; Dai, Yang-Shia; Chu, Kuan-Hua; Sun, Chi; Lin, Yu-Tsan; Wang, Li-Chieh; Yu, Hsin-Hui; Yang, Yao-Hsu; Chen, Chun-An; Wan, Kong-Sang; Chiang, Bor-Luen

    2016-01-01

    Sleep disturbance is common in children with atopic dermatitis (AD), but effective clinical management for this problem is lacking. Reduced levels of nocturnal melatonin were found to be associated with sleep disturbance and increased disease severity in children with AD. Melatonin also has sleep-inducing and anti-inflammatory properties and therefore might be useful for the management of AD. To evaluate the effectiveness of melatonin supplementation for improving the sleep disturbance and severity of disease in children with AD. This randomized clinical trial used a double-blind, placebo-controlled crossover design to study 73 children and adolescents aged 1 to 18 years with physician-diagnosed AD involving at least 5% of the total body surface area. The study was conducted at the pediatric department of a large tertiary care hospital in Taiwan from August 1, 2012, through January 31, 2013. Forty-eight children were randomized 1:1 to melatonin or placebo treatment, and 38 of these (79%) completed the cross-over period of the trial. Final follow-up occurred on April 13, 2013, and data were analyzed from January 27 to April 25, 2014. Analyses were based on intention to treat. Melatonin, 3 mg/d, or placebo for 4 weeks followed by a 2-week washout period and then crossover to the alternate treatment for 4 weeks. The primary outcome was AD severity evaluated using the Scoring Atopic Dermatitis (SCORAD) index, with scores ranging from 0 to 103 and greater scores indicating worse symptoms. Secondary outcomes included sleep variables measured by actigraphy, subjective change in sleep and dermatitis, sleep variables measured by polysomnography, nocturnal urinary levels of 6-sulfatoxymelatonin, and serum IgE levels. After melatonin treatment among the 48 children included in the study, the SCORAD index decreased by 9.1 compared with after placebo (95% CI, -13.7 to -4.6; P sleep-onset latency shortened by 21.4 minutes after melatonin treatment compared with after placebo

  11. Effect of Topical Furosemide on Rhinosinusal Polyposis Relapse After Endoscopic Sinus Surgery: A Randomized Clinical Trial.

    Science.gov (United States)

    Hashemian, Farnaz; Ghorbanian, Mohammad Ali; Hashemian, Farshad; Mortazavi, Seyed Alireza; Sheikhi, Mojgan; Jahanshahi, Javaneh; Poorolajal, Jalal

    2016-11-01

    Evidence from previous studies suggests that furosemide may be effective in reducing the recurrence of polyps after sinus surgery. However, the evidence is limited and insufficient, and further investigations are required. To assess the effect of topical furosemide on recurrence rate of rhinosinusal polyposis after endoscopic sinus surgery. Triple-blind randomized clinical trial of patients aged 18 to 60 years with chronic rhinosinusitis associated with polyposis who did not respond to medical treatment and were candidates for endoscopic sinus surgery at Besat Hospital, Hamadan University of Medical Sciences, from April 2014 to June 2015. Patients were randomly assigned to receive postoperative nasal spray, 2 puffs twice a day for 2 months, either 300 µg of furosemide per day or placebo. Six months after surgery, the patients were examined for nasal and paranasal sinus polyposis using Meltzer endoscopic grading, computed tomographic (CT) scan of paranasal sinuses (PNS) scoring, Sino-Nasal Outcome Test (SNOT-22) scoring, and visual analog scale (VAS). Of 110 patients enrolled, 84 patients remained for analysis (53 men and 31 women; mean age in the furosemide group, 37.02 years, range, 18-58 years; mean age in the placebo group, 36.30 years, range, 18-60 years). Six months after the intervention, the grade of polyposis decreased in both groups, but this reduction was substantial in the furosemide group vs the placebo group. The severity of polyposis was significantly lower in the furosemide group vs the placebo group based on SNOT-22 scoring (difference, 8.05; 95% CI, 3.24-12.85) and VAS (difference, 0.81; 95% CI, 0.22-1.39) but not significantly different based on CT scan of PNS scoring (difference, 2.52; 95% CI, -0.35 to 5.39). The incidence of adverse effects (nasal irritation, headache, and constipation) were not significantly different between the 2 groups. These findings indicate that topical furosemide is a safe drug, with no important adverse effects, that

  12. Rehabilitation After Immobilization for Ankle Fracture: The EXACT Randomized Clinical Trial.

    Science.gov (United States)

    Moseley, Anne M; Beckenkamp, Paula R; Haas, Marion; Herbert, Robert D; Lin, Chung-Wei Christine

    2015-10-06

    The benefits of rehabilitation after immobilization for ankle fracture are unclear. To determine the effectiveness of a supervised exercise program and advice (rehabilitation) compared with advice alone and to determine if effects are moderated by fracture severity or age and sex. The EXACT trial was a pragmatic, randomized clinical trial conducted from December 2010 to June 2014. Patients with isolated ankle fracture presenting to fracture clinics in 7 Australian hospitals were randomized on the day of removal of immobilization. Of 571 eligible patients, 357 chose not to participate and 214 were allocated to rehabilitation (n = 106) or advice alone (n = 108), with 194 (91%) followed up at 1 month, 173 (81%) at 3 months, and 170 (79%) at 6 months. There were no withdrawals attributed to adverse effects. Recruitment terminated early on December 31, 2013 (planned enrollment, 342; actual, 214), because funding was exhausted. Supervised exercise program and advice about self-management (rehabilitation) (individually tailored, prescribed, monitored, and progressed) or advice alone, both delivered by a physical therapist. Primary outcomes were activity limitation assessed using the Lower Extremity Functional Scale (score range, 0-80; higher scores indicate better activity), and quality of life assessed using the Assessment of Quality of Life (score range, 0-1; higher scores indicate better quality of life), measured at baseline and at 1, 3 (primary time point), and 6 months. Mean activity limitation and quality of life at baseline were 30.1 (SD, 12.5) and 0.51 (SD, 0.24), respectively, for advice and 30.2 (SD, 13.2) and 0.54 (SD, 0.24) for rehabilitation, increasing to 64.3 (SD, 13.5) and 0.85 (SD, 0.17) for advice vs 64.3 (SD, 15.1) and 0.85 (SD, 0.20) for rehabilitation at 3 months. Rehabilitation was not more effective than advice for activity limitation (mean effect at 3 months, 0.4 [95% CI, -3.3 to 4.1]) or quality of life (-0.01 [95% CI, -0.06 to 0

  13. Comparison of isotonic and hypotonic intravenous maintenance fluids: a randomized clinical trial.

    Science.gov (United States)

    Friedman, Jeremy N; Beck, Carolyn E; DeGroot, Julie; Geary, Denis F; Sklansky, Daniel J; Freedman, Stephen B

    2015-05-01

    Use of hypotonic intravenous fluids for maintenance requirements is associated with increased risk of hyponatremia that results in morbidity and mortality in children. Clinical trial data comparing isotonic and hypotonic maintenance fluids in nonsurgical hospitalized pediatric patients outside intensive care units are lacking. To compare isotonic (sodium chloride, 0.9%, and dextrose, 5%) with hypotonic (sodium chloride, 0.45%, and dextrose, 5%) intravenous maintenance fluids in a hospitalized general pediatric population. In this double-blind randomized clinical trial,we recruited 110 children admitted to a general pediatric unit of a tertiary care children's hospital from March 1, 2008, through August 31, 2012 (age range, 1 month to 18 years), with normal baseline serum sodium levels who were anticipated to require intravenous maintenance fluids for 48 hours or longer (intent-to-treat analyses). Children with diagnoses that required specific fluid tonicity and volumes were excluded. Patients were randomized to receive isotonic or hypotonic intravenous fluid at maintenance rates for 48 hours. The primary outcome was mean serum sodium level at 48 hours. The secondary outcomes were mean sodium level at 24 hours, hyponatremia and hypernatremia, weight gain, hypertension, and edema. Confounding variables were included in multiple regression models. Post hoc analyses included change from baseline sodium level at 24 and 48 hours and subgroup analysis of children with primary respiratory diagnosis. Of 110 enrolled patients, 54 received isotonic fluids and 56 received hypotonic fluids. The mean (SD) sodium level at 48 hours was 139.9 (2.7) mEq/L in the isotonic group and 139.6 (2.6) mEq/L in the hypotonic group (95% CI of the difference, -0.94 to 1.74 mEq/L; P = .60). Two patients in the hypotonic group developed hyponatremia, 1 in each group developed hypernatremia, 2 in each group developed hypertension, and 2 in the isotonic group developed edema. Mean (SD

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

    Science.gov (United States)

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

    2014-09-19

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

  15. Vitamin D supplementation and growth in urban Mongol school children: Results from two randomized clinical trials.

    Directory of Open Access Journals (Sweden)

    Davaasambuu Ganmaa

    Full Text Available Symptomatic vitamin D deficiency is associated with slowed growth in children. It is unknown whether vitamin D repletion in children with asymptomatic serum vitamin D deficiency can restore normal growth.We tested the impact of vitamin D-supplementation on serum concentrations of 25-hydroxyvitamin D [25(OHD] and short-term growth in Mongol children, with very low serum vitamin D levels in winter.We conducted two randomized, double-blind, placebo-controlled trials in urban school age children without clinical signs of rickets. The Supplementation Study was a 6-month intervention with an 800 IU vitamin D3 supplement daily, compared with placebo, in 113 children aged 12-15 years. A second study, the Fortification Study, was a 7-week intervention with 710 ml of whole milk fortified with 300 IU vitamin D3 daily, compared with unfortified milk, in 235 children aged 9-11 years.At winter baseline, children had low vitamin D levels, with a mean (±SD serum 25-hydroxyvitamin D [25(OHD] concentration of 7.3 (±3.9 ng/ml in the Supplementation Study and 7.5 (±3.8 ng/ml in the Fortification Study. The serum levels increased in both vitamin D groups-by 19.8 (±5.1 ng/ml in the Supplementation Study, and 19.7 (±6.1 ng/ml in the Fortification Study. Multivariable analysis showed a 0.9 (±0.3 SE cm greater increase in height in the vitamin-D treated children, compared to placebo treated children, in the 6-month Supplementation Study (p = 0.003. Although the children in the 7-week Fortification Study intervention arm grew 0.2 (±0.1 cm more, on average, than placebo children this difference was not statistically significant (p = 0.2. There were no significant effects of vitamin D supplements on differences in changes in weight or body mass index in either trial. For the Fortification Study, girls gained more weight than boys while taking vitamin D 3 (p-value for interaction = 0.03, but sex was not an effect modifier of the relationship between vitamin D3 and

  16. Vitamin D supplementation and growth in urban Mongol school children: Results from two randomized clinical trials.

    Science.gov (United States)

    Ganmaa, Davaasambuu; Stuart, Jennifer J; Sumberzul, Nyamjav; Ninjin, Boldbaatar; Giovannucci, Edward; Kleinman, Ken; Holick, Michael F; Willett, Walter C; Frazier, Lindsay A; Rich-Edwards, Janet W

    2017-01-01

    Symptomatic vitamin D deficiency is associated with slowed growth in children. It is unknown whether vitamin D repletion in children with asymptomatic serum vitamin D deficiency can restore normal growth. We tested the impact of vitamin D-supplementation on serum concentrations of 25-hydroxyvitamin D [25(OH)D] and short-term growth in Mongol children, with very low serum vitamin D levels in winter. We conducted two randomized, double-blind, placebo-controlled trials in urban school age children without clinical signs of rickets. The Supplementation Study was a 6-month intervention with an 800 IU vitamin D3 supplement daily, compared with placebo, in 113 children aged 12-15 years. A second study, the Fortification Study, was a 7-week intervention with 710 ml of whole milk fortified with 300 IU vitamin D3 daily, compared with unfortified milk, in 235 children aged 9-11 years. At winter baseline, children had low vitamin D levels, with a mean (±SD) serum 25-hydroxyvitamin D [25(OH)D] concentration of 7.3 (±3.9) ng/ml in the Supplementation Study and 7.5 (±3.8) ng/ml in the Fortification Study. The serum levels increased in both vitamin D groups-by 19.8 (±5.1) ng/ml in the Supplementation Study, and 19.7 (±6.1) ng/ml in the Fortification Study. Multivariable analysis showed a 0.9 (±0.3 SE) cm greater increase in height in the vitamin-D treated children, compared to placebo treated children, in the 6-month Supplementation Study (p = 0.003). Although the children in the 7-week Fortification Study intervention arm grew 0.2 (±0.1) cm more, on average, than placebo children this difference was not statistically significant (p = 0.2). There were no significant effects of vitamin D supplements on differences in changes in weight or body mass index in either trial. For the Fortification Study, girls gained more weight than boys while taking vitamin D 3 (p-value for interaction = 0.03), but sex was not an effect modifier of the relationship between vitamin D3 and change

  17. Long-term clinical effect of adjunctive antimicrobial photodynamic therapy in periodontal treatment: a randomized clinical trial.

    Science.gov (United States)

    Alwaeli, Haider A; Al-Khateeb, Susan N; Al-Sadi, Amani

    2015-02-01

    Mechanical removal of microbial biofilm dental plaque from tooth surfaces is important for treatment of periodontal diseases. However, the effectiveness of conventional scaling and root planing (SRP) is affected by the local conditions and residual bacteria which may affect the healing process. We performed a randomized clinical trial to test our hypothesis that adjunctive antimicrobial photodynamic therapy (aPDT) plus SRP has significant effect compared with SRP alone, which can last for 1 year. The study included 136 sites in 16 patients with previously untreated chronic periodontitis, at least one premolar and one molar in every quadrant (minimum, four teeth/quadrant) and at least one tooth with attachment loss of ≥4 mm in every quadrant. In all patients, two randomly assigned quadrants were treated with SRP and the other two were treated with SRP + aPDT. The clinical parameters of probing pocket depth (PPD), bleeding on probing (BOP), and clinical attachment level (CAL) were evaluated at baseline and after 3, 6, and 12 months. There were no significant differences between the two groups at baseline. PPD and BOP showed significant reduction, and CAL showed significant gain from baseline for all three time points in both groups. In addition, there were significantly greater reduction and gain for SRP + aPDT than for SRP at all three time points. No adverse effects of aPDT were observed. These data demonstrate significant improvement in all evaluated clinical parameters for at least 1 year and suggest that aPDT as an adjunctive therapy to SRP represents a promising therapeutic concept for persistent periodontitis.

  18. Comparative Clinical Study of Conventional Dental Implants and Mini Dental Implants for Mandibular Overdentures: A Randomized Clinical Trial.

    Science.gov (United States)

    Aunmeungtong, Weerapan; Kumchai, Thongnard; Strietzel, Frank P; Reichart, Peter A; Khongkhunthian, Pathawee

    2017-04-01

    Dental implant-retained overdentures have been chosen as the treatment of choice for complete mandibular removable dentures. Dental implants, such as mini dental implants, and components for retaining overdentures, are commercially available. However, comparative clinical studies comparing mini dental implants and conventional dental implants using different attachment for implant-retained overdentures have not been well documented. To compare the clinical outcomes of using two mini dental implants with Equator ® attachments, four mini dental implants with Equator attachments, or two conventional dental implants with ball attachments, by means of a randomized clinical trial. Sixty patients received implant-retained mandibular overdentures in the interforaminal region. The patients were divided into three groups. In Groups 1 and 2, two and four mini dental implants, respectively, were placed and immediately loaded by overdentures, using Equator ® attachments. In Group 3, conventional implants were placed. After osseointegration, the implants were loaded by overdentures, using ball attachments. The study distribution was randomized and double-blinded. Outcome measures included changes in radiological peri-implant bone level from surgery to 12 months postinsertion, prosthodontic complications and patient satisfaction. The cumulative survival rate in the three clinical groups after one year was 100%. There was no significant difference (p dental implants with Equator attachments. However, there was a significant difference in marginal bone loss and patient satisfaction between those receiving mini dental implants with Equator attachments and conventional dental implants with ball attachments. The marginal bone resorption in Group 3 was significantly higher than in Groups 1 and 2 (p dental implants can be immediately used successfully for retaining lower complete dentures, as shown after a 1-year follow up. © 2016 Wiley Periodicals, Inc.

  19. Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Randomized Clinical Trial.

    Science.gov (United States)

    Weersing, V Robin; Brent, David A; Rozenman, Michelle S; Gonzalez, Araceli; Jeffreys, Megan; Dickerson, John F; Lynch, Frances L; Porta, Giovanna; Iyengar, Satish

    2017-06-01

    Anxiety and depression affect 30% of youth but are markedly undertreated compared with other mental disorders, especially in Hispanic populations. To examine whether a pediatrics-based behavioral intervention targeting anxiety and depression improves clinical outcome compared with referral to outpatient community mental health care. This 2-center randomized clinical trial with masked outcome assessment conducted between brief behavioral therapy (BBT) and assisted referral to care (ARC) studied 185 youths (aged 8.0-16.9 years) from 9 pediatric clinics in San Diego, California, and Pittsburgh, Pennsylvania, recruited from October 6, 2010, through December 5, 2014. Youths who met DSM-IV criteria for full or probable diagnoses of separation anxiety disorder, generalized anxiety disorder, social phobia, major depression, dysthymic disorder, and/or minor depression; lived with a consenting legal guardian for at least 6 months; and spoke English were included in the study. Exclusions included receipt of alternate treatment for anxiety or depression, presence of a suicidal plan, bipolar disorder, psychosis, posttraumatic stress disorder, substance dependence, current abuse, intellectual disability, or unstable serious physical illness. The BBT consisted of 8 to 12 weekly 45-minute sessions of behavioral therapy delivered in pediatric clinics by master's-level clinicians. The ARC families received personalized referrals to mental health care and check-in calls to support accessing care from master's-level coordinators. The primary outcome was clinically significant improvement on the Clinical Global Impression-Improvement scale (score ≤2). Secondary outcomes included the Pediatric Anxiety Rating Scale, Children's Depression Rating Scale-Revised, and functioning. A total of 185 patients were enrolled in the study (mean [SD] age, 11.3 [2.6] years; 107 [57.8%] female; 144 [77.8%] white; and 38 [20.7%] Hispanic). Youths in the BBT group (n = 95), compared with those in

  20. Effects of Steroids on Quality of Recovery and Adverse Events after General Anesthesia: Meta-Analysis and Trial Sequential Analysis of Randomized Clinical Trials.

    Science.gov (United States)

    Mihara, Takahiro; Ishii, Tomoko; Ka, Koui; Goto, Takahisa

    2016-01-01

    Quality of recovery (QoR) after surgery is a relevant outcome. The early postoperative quality of recovery of a patient can be determined using the QoR-40 questionnaire. The aim of this meta-analysis and Trial Sequential Analysis was to determine if perioperative administration of glucocorticosteroids improved patients' quality of recovery after general anesthesia and if adverse events occurred. We searched six databases, including trial registration sites. Randomized clinical trials reporting the efficacy of glucocorticosteroids on quality of recovery evaluated using the QoR-40 after general anesthesia were eligible. The QoR-40 data were combined as the mean difference with confidence intervals using a random-effects model. The I2 statistic was used to assess heterogeneity. The quality of the trials was evaluated using the Cochrane methodology. Moreover, Trial Sequential Analysis was carried out to prevent the inflation of type 1 errors caused by multiple testing and sparse data. We also assessed adverse events. Three randomized clinical trials (totaling 301 patients) were analyzed. The results from one published and four unpublished randomized clinical trials were unavailable. Dexamethasone was investigated in all three trials, and the results suggested that it significantly improved QoR-40 at postoperative day one scores compared with placebo (mean difference [95% confidence interval]: 14.2 points [10.4 to 18.1]; P analysis because of the absence of trials with low risk of bias. The Trial Sequential Analysis-adjusted confidence interval was -1.6 to 30.0, indicating that further trials are required. The reporting of adverse events was insufficient. These findings indicate that perioperative dexamethasone administration may improve short-term (i.e., one day) quality of recovery after general anesthesia and surgery. We need more randomized clinical trials with low risk of bias assessing the effects of glucocorticosteroids on quality of life, other outcomes, and

  1. Astym treatment vs. eccentric exercise for lateral elbow tendinopathy: a randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Thomas L. Sevier

    2015-05-01

    Full Text Available Introduction. Patients with chronic lateral elbow (LE tendinopathy, commonly known as tennis elbow, often experience prolonged symptoms and frequent relapses. Astym treatment, evidenced in animal studies to promote the healing and regeneration of soft tissues, is hypothesized to improve outcomes in LE tendinopathy patients. This study had two objectives: (1 to compare the efficacy of Astym treatment to an evidence-based eccentric exercise program (EE for patients with chronic LE tendinopathy, and (2 to quantify outcomes of subjects non-responsive to EE who were subsequently treated with Astym treatment.Study Design. Prospective, two group, parallel, randomized controlled trial completed at a large orthopedic center in Indiana. Inclusion criteria: age range of 18–65 years old, with clinical indications of LE tendinopathy greater than 12 weeks, with no recent corticosteriod injection or disease altering comorbidities.Methods. Subjects with chronic LE tendinopathy (107 subjects with 113 affected elbows were randomly assigned using computer-generated random number tables to 4 weeks of Astym treatment (57 elbows or EE treatment (56 elbows. Data collected at baseline, 4, 8, 12 weeks, 6 and 12 months. Primary outcome measure: DASH; secondary outcome measures: pain with activity, maximum grip strength and function. The treating physicians and the rater were blinded; subjects and treating clinicians could not be blinded due to the nature of the treatments.Results. Resolution response rates were 78.3% for the Astym group and 40.9% for the EE group. Astym subjects showed greater gains in DASH scores (p = 0.047 and in maximum grip strength (p = 0.008 than EE subjects. Astym therapy also resolved 20/21 (95.7% of the EE non-responders, who showed improvements in DASH scores (p < 0.005, pain with activity (p = 0.002, and function (p = 0.004 following Astym treatment. Gains continued at 6 and 12 months. No adverse effects were reported.Conclusion. This study

  2. TOPICAL MITOMYCIN C IN DACRIOCYSTORHINOSTOMY: ITS EFFECT ON FAILURE RATE OF PROCEDURE - A RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    A ZANDI

    2002-03-01

    Full Text Available Introduction. Epiphoria is one of the most common symptom among patients in ophtalmologic clinics. The most important cause of it, is tear drainage obstrution through the nasolacrimal duct. Dacryocystorhinostomy (DCR is the only critical treatment. The failure is important complication of DCR and in spite of varios methods, failure rate has remained 10 percent. Ingrowgh of fibrous tissue in osteotomy site and flaps has been known as cause of surgical failue. In this study we investigated the efficacy of mitomycin C as antiproliferative agent on DCR failure rate. Methods. In this clinical trial study, 110 patients with primary acquired nasolacrimal duct obstruction have been chosen between who that refer to the Farabi clinic, and were assigned randomly to either mitomycin or control group. Both group were operated with standard method and one surgen. In control group a cotton aid band and in interventional group a cottonoid band soaked with 0.2 mg/cc mitomycin C was applied to the osteotomy site. After 30 minutes was removed transnasaly. Groups have been examined at 1, 3 and 6 months intervals after surgery. Results. All patients in mitomycin group remained symptom free in all examination, and there was five pateints in control group who had recurrent epiphora. In the control group, 3 patients in 1 st month, 1 patient in 3rd months and 1 patient in 6th month were failed. In 3 patients of mitomycin group, severe post operative bleeding was seen. Discussion. The difference between these groups is (P < 0.01. Intraoperative mitomycin C may possibly improve success rates of DCR procedure with no serious complication.

  3. A randomized, double-blind, placebo-controlled clinical trial of fluoride varnish in preventing dental caries of Sjogrens syndrome patients

    National Research Council Canada - National Science Library

    Weini Xin; Katherine Chiu Man Leung; Edward Chin Man Lo; Mo Yin Mok; Moon Ho Leung

    2016-01-01

    .... Topical fluoride is commonly prescribed for caries prevention. Methods In this 24-month randomized, double-blind, placebo-controlled clinical trial, SS patients were randomly assigned to receive either fluoride varnish or placebo gel quarterly...

  4. A two-way enriched clinical trial design: combining advantages of placebo lead-in and randomized withdrawal.

    Science.gov (United States)

    Ivanova, Anastasia; Tamura, Roy N

    2015-12-01

    A new clinical trial design, designated the two-way enriched design (TED), is introduced, which augments the standard randomized placebo-controlled trial with second-stage enrichment designs in placebo non-responders and drug responders. The trial is run in two stages. In the first stage, patients are randomized between drug and placebo. In the second stage, placebo non-responders are re-randomized between drug and placebo and drug responders are re-randomized between drug and placebo. All first-stage data, and second-stage data from first-stage placebo non-responders and first-stage drug responders, are utilized in the efficacy analysis. The authors developed one, two and three degrees of freedom score tests for treatment effect in the TED and give formulae for asymptotic power and for sample size computations. The authors compute the optimal allocation ratio between drug and placebo in the first stage for the TED and compare the operating characteristics of the design to the standard parallel clinical trial, placebo lead-in and randomized withdrawal designs. Two motivating examples from different disease areas are presented to illustrate the possible design considerations. © The Author(s) 2011.

  5. RANDOMIZED CLINICAL TRIAL: SOLUBLE/INSOLUBLE FIBER OR PSYLLIUM FOR CHRONIC CONSTIPATION

    Science.gov (United States)

    Erdogan, Askin; Rao, Satish; Thiruvaiyaru, Dharma; Lee, Yeong Yeh; Adame, Enrique Coss; Valestin, Jessica; O’Banion, Meagan

    2016-01-01

    SUMMARY Background Fiber supplements are useful, but whether a plum-derived mixed fiber that contains both soluble and insoluble fiber improves constipation is unknown. Aim We investigated the efficacy and tolerability of mixed fiber versus psyllium in a randomized double blind controlled trial. Methods Constipated patients (Rome III) received mixed fiber or psyllium, 5g bid, for 4 weeks. Daily symptoms and stool habit were assessed using stool diary. Subjects with ≥1 complete spontaneous bowel movement (CSBM)/week above baseline for ≥ 2/4 weeks were considered responders. Secondary outcome measures included stool consistency, bowel satisfaction, straining, gas, bloating, taste, dissolvability and Quality of Life (QOL). Results 72 subjects (MF=40; psyllium=32) were enrolled and 2 from psyllium group withdrew. The mean CSBM/week increased with both mixed fiber (ppsyllium (p=0.0002) without group difference. There were 30 (75%) responders with mixed fiber and 24 (75%) with psyllium (p=0.9). Stool consistency increased (p=0.04), straining (p=0.006), and bloating scores decreased (p=0.02) without group differences. Significantly more patients reported improvement in flatulence (53% vs. 25%, p=0.01) and felt that mixed fiber dissolved better (p=0.02) compared to psyllium. QOL improved (p=0.0125) with both treatments without group differences. Conclusions Mixed fiber and psyllium were equally efficacious in improving constipation and QOL. Mixed fiber was more effective in relieving flatulence, bloating and dissolved better. Mixed fiber is effective and well tolerated. Clinical Trial No: NCT01288508 PMID:27125883

  6. Systematic review and meta-analysis of randomized clinical trials in the treatment of human brucellosis.

    Directory of Open Access Journals (Sweden)

    Julián Solís García del Pozo

    Full Text Available BACKGROUND: Brucellosis is a persistent health problem in many developing countries throughout the world, and the search for simple and effective treatment continues to be of great importance. METHODS AND FINDINGS: A search was conducted in MEDLINE and in the Cochrane Central Register of Controlled Trials (CENTRAL. Clinical trials published from 1985 to present that assess different antimicrobial regimens in cases of documented acute uncomplicated human brucellosis were included. The primary outcomes were relapse, therapeutic failure, combined variable of relapse and therapeutic failure, and adverse effect rates. A meta-analysis with a fixed effect model was performed and odds ratio with 95% confidence intervals were calculated. A random effect model was used when significant heterogeneity between studies was verified. Comparison of combined doxycycline and rifampicin with a combination of doxycycline and streptomycin favors the latter regimen (OR = 3.17; CI95% = 2.05-4.91. There were no significant differences between combined doxycycline-streptomycin and combined doxycycline-gentamicin (OR = 1.89; CI95% = 0.81-4.39. Treatment with rifampicin and quinolones was similar to combined doxycycline-rifampicin (OR = 1.23; CI95% = 0.63-2.40. Only one study assessed triple therapy with aminoglycoside-doxycycline-rifampicin and only included patients with uncomplicated brucellosis. Thus this approach cannot be considered the therapy of choice until further studies have been performed. Combined doxycycline/co-trimoxazole or doxycycline monotherapy could represent a cost-effective alternative in certain patient groups, and further studies are needed in the future. CONCLUSIONS: Although the preferred treatment in uncomplicated human brucellosis is doxycycline-aminoglycoside combination, other treatments based on oral regimens or monotherapy should not be rejected until they are better studied. Triple therapy should not be considered

  7. Effects of doxycycline on local and systemic inflammation in stable COPD patients, a randomized clinical trial.

    Science.gov (United States)

    Prins, Hendrik J; Daniels, Johannes M A; Lindeman, Jan H; Lutter, René; Boersma, Wim G

    2016-01-01

    Neutrophilic inflammation plays a causal role in Chronic Obstructive Pulmonary Disease (COPD). Neutrophil derived myeloperoxidase(MPO) matrix metalloproteinases(MMP's), and elastases are thought to contribute to the perpetuation of the disease. The tetracycline analogue doxycycline has been shown to inhibit neutrophil-mediated inflammation. It was thus reasoned that doxycycline may attenuate neutrophil-mediated inflammation in COPD. In this double blind randomized controlled trial the effect of a 3-week course of doxycycline on sputum and systemic inflammatory parameters was evaluated in stable COPD patients. In order to exclude inflammation by bacterial colonisation patients must have 2 negative sputum cultures in the previous year. The effect of doxycycline treatment on inflammatory markers (TNF-α, IL-1β and IL-6) and neutrophil specific markers in sputum (MPO, MMP's, and IL-8) and serum C-reactive protein was evaluated. Sputum was obtained by sputum induction with hypertonic saline. A total of 41 patients were included. Ten patients were excluded as they were not able to produce sputum at the first or second visit. Baseline characteristics were similar in the two groups. In the remaining patients doxycycline did not influence sputum MPO concentrations. Also MMP-8 and 9, IL-6 and IL-8 concentrations as well as lung function parameters were not affected by doxycycline. Systemic inflammation by means of CRP was also not influenced by doxycycline. A three week course of doxycycline did not influence MPO sputum levels nor any of the other inflammatory sputum and systemic markers. ClinicalTrials.gov; No.: NCT00857038 URL: clinicaltrials.gov. Copyright © 2015 Elsevier Ltd. All rights reserved.

  8. Effectiveness of intra-articular lidocaine injection for reduction of anterior shoulder dislocation: randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Marcel Jun Sugawara Tamaoki

    Full Text Available CONTEXT AND OBJECTIVE: Shoulder dislocation is the most common dislocation among the large joints. The aim here was to compare the effectiveness of reduction of acute anterior shoulder dislocation with or without articular anesthesia. DESIGN AND SETTING: Prospective randomized trial conducted in Escola Paulista de Medicina, Universidade Federal de São Paulo (EPM-Unifesp. METHODS: From March 2008 to December 2009, 42 patients with shoulder dislocation were recruited. Reductions using traction-countertraction for acute anterior shoulder dislocation with and without lidocaine articular anesthesia were compared. As the primary outcome, pain was assessed through application of a visual analogue scale before reduction, and one and five minutes after the reduction maneuver was performed. Complications were also assessed. RESULTS: Forty-two patients were included: 20 in the group without analgesia (control group and 22 in the group that received intra-articular lidocaine injection. The group that received intra-articular lidocaine had a statistically greater decrease in pain over time than shown by the control group, both in the first minute (respectively: mean 2.1 (0 to 5.0, standard deviation, SD 1.3, versus mean 4.9 (2.0 to 7.0, SD 1.5; P < 0.001 and the fifth minute (respectively: mean 1.0; 0 to 3.0; SD = 1.0 versus mean 4.0; 1.0 to 6.0; SD = 1.4; P < 0.001. There was one failure in the control group. There were no other complications in either group. CONCLUSION: Reduction of anterior shoulder dislocation using intra-articular lidocaine injection is effective, since it is safe and diminishes the pain. CLINICAL TRIAL REGISTRATION: ISRCTN27127703.

  9. Systematic Review and Meta-Analysis of Randomized Clinical Trials in the Treatment of Human Brucellosis

    Science.gov (United States)

    Solís García del Pozo, Julián; Solera, Javier

    2012-01-01

    Background Brucellosis is a persistent health problem in many developing countries throughout the world, and the search for simple and effective treatment continues to be of great importance. Methods and Findings A search was conducted in MEDLINE and in the Cochrane Central Register of Controlled Trials (CENTRAL). Clinical trials published from 1985 to present that assess different antimicrobial regimens in cases of documented acute uncomplicated human brucellosis were included. The primary outcomes were relapse, therapeutic failure, combined variable of relapse and therapeutic failure, and adverse effect rates. A meta-analysis with a fixed effect model was performed and odds ratio with 95% confidence intervals were calculated. A random effect model was used when significant heterogeneity between studies was verified. Comparison of combined doxycycline and rifampicin with a combination of doxycycline and streptomycin favors the latter regimen (OR = 3.17; CI95% = 2.05–4.91). There were no significant differences between combined doxycycline-streptomycin and combined doxycycline-gentamicin (OR = 1.89; CI95% = 0.81–4.39). Treatment with rifampicin and quinolones was similar to combined doxycycline-rifampicin (OR = 1.23; CI95% = 0.63–2.40). Only one study assessed triple therapy with aminoglycoside-doxycycline-rifampicin and only included patients with uncomplicated brucellosis. Thus this approach cannot be considered the therapy of choice until further studies have been performed. Combined doxycycline/co-trimoxazole or doxycycline monotherapy could represent a cost-effective alternative in certain patient groups, and further studies are needed in the future. Conclusions Although the preferred treatment in uncomplicated human brucellosis is doxycycline-aminoglycoside combination, other treatments based on oral regimens or monotherapy should not be rejected until they are better studied. Triple therapy should not be considered the current

  10. Flixweed vs. Polyethylene Glycol in the Treatment of Childhood Functional Constipation: A Randomized Clinical Trial.

    Science.gov (United States)

    Nimrouzi, Majid; Sadeghpour, Omid; Imanieh, Mohammad Hadi; Shams Ardekani, Mohammadreza; Salehi, Alireza; Minaei, Mohamad Bagher; Zarshenas, Mohammad M

    2015-04-01

    Polyethylene glycol (PEG) is often considered as the first-line treatment for functional constipation in children. Descurainia sophia (L.) Webb et Berth (D. sophia) is a safe recommended medicine in Iranian folk and Traditional Persian Medicine for the treatment of constipation. To clinically compare D. sophia with PEG 4000 (without electrolyte) in pediatric constipation and to assess its efficacy and side effects. 120 patients aged 2 - 12 years with constipation for at least 3 months were included in an 8 weeks lasting randomized controlled trial within two parallel-groups. Children received either PEG, 0.4 g/kg/day, or D. sophia seeds, 2 grams (for children aged 2 - 4 years) and 3 grams (for those aged > 4 years) per day. A total of 109 patients completed the study (56 in D. sophia and 53 in PEG group). At the end of the study, 36 (64.3%) patients in D. sophia group and 29 (54.7%) in PEG group were out of Rome III criteria (P = 0.205). Median weekly stool frequency in 0, 1, 2, 3 weeks of the treatment was found to be 2, 5, 5, 5 in D. sophia and 3, 4, 4, 5 in PEG group (P = 0.139, 0.076, 0.844, 0.294), respectively. The number of patients who suffered flatulence was less (5, 8.9%) in D. sophia group as compared to PEG group (6, 11.3%) at the end of the trial (P = 0.461). D. sophia taste was less tolerated. D. sophia is introduced as a cheap and available medication which can be applied as a safe alternative to conventional PEG in the management of pediatric chronic functional constipation.