Science.gov

Sample records for medicine trial launched

  1. NCI, FNLCR Help Launch Pediatric MATCH Precision Medicine Trial | Poster

    Cancer.gov

    The National Cancer Institute and Children’s Oncology Group recently opened enrollment for a new Phase II trial of personalized precision cancer therapies. Called the Pediatric Molecular Analysis for Therapy Choice (Pediatric MATCH), the trial seeks to treat children and adolescents aged 1­–21 whose solid tumors have failed to respond to or re-emerged after traditional cancer treatments.

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

    Cancer.gov

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

  3. Anchor Trial Launch

    Cancer.gov

    NCI has launched a multicenter phase III clinical trial called the ANCHOR Study -- Anal Cancer HSIL (High-grade Squamous Intraepithelial Lesion) Outcomes Research Study -- to determine if treatment of HSIL in HIV-infected individuals can prevent anal canc

  4. NIH announces the launch of 3 integrated precision medicine trials: ALCHEMIST

    Cancer.gov

    The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trials, or ALCHEMIST, will identify early-stage lung cancer patients with tumors that harbor certain uncommon genetic changes and evaluate whether drug treatments targeted against

  5. Clinical trials and gender medicine.

    PubMed

    Cassese, Mariarita; Zuber, Veronica

    2011-01-01

    Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22%) which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa) which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  6. Challenges in launching multinational oncology clinical trials in India

    PubMed Central

    Saini, Kamal S.; Agarwal, Gaurav; Jagannathan, Ramesh; Metzger-Filho, Otto; Saini, Monika L.; Mistry, Khurshid; Ali, Raghib; Gupta, Sudeep

    2013-01-01

    In the recent past, there has been an impressive growth in the number of clinical trials launched worldwide, including India. Participation in well-designed oncology clinical trials is of advantage to Indian healthcare system in general, and cancer patients in particular. However, the number of clinical trials being run in India is not commensurate with the cancer burden prevailing in the country. In this article, the authors investigate the reasons for this discrepancy, highlight critical bottlenecks, and propose ways to ameliorate the situation. PMID:24455545

  7. Clinical trials for predictive medicine.

    PubMed

    Simon, Richard

    2012-11-10

    Developments in biotechnology and genomics are providing a biological basis for the heterogeneity of clinical course and response to treatment that have long been apparent to clinicians. The ability to molecularly characterize human diseases presents new opportunities to develop more effective treatments and new challenges for the design and analysis of clinical trials. In oncology, treatment of broad populations with regimens that benefit a minority of patients is less economically sustainable with expensive molecularly targeted therapeutics. The established molecular heterogeneity of human diseases requires the development of new paradigms for the design and analysis of randomized clinical trials as a reliable basis for predictive medicine. We review prospective designs for the development of new therapeutics and predictive biomarkers to inform their use. We cover designs for a wide range of settings. At one extreme is the development of a new drug with a single candidate biomarker and strong biological evidence that marker negative patients are unlikely to benefit from the new drug. At the other extreme are Phase III clinical trials involving both genome-wide discovery of a predictive classifier and internal validation of that classifier. We have outlined a prediction-based approach to the analysis of randomized clinical trials that both preserves the Type I error and provides a reliable internally validated basis for predicting which patients are most likely or unlikely to benefit from the new regimen.

  8. Recruitment and Retention of Patients into Emergency Medicine Clinical Trials

    PubMed Central

    Cofield, Stacey; Conwit, Robin; Barsan, William; Quinn, James

    2010-01-01

    The emergency medicine and pre-hospital environments are unlike any other clinical environments and require special consideration to allow the successful implementation of clinical trials. This article reviews the specific issues involved in Emergency Medicine Clinical Trials (EMCT), and provides strategies from emergency medicine and non-emergency medicine trials to maximize recruitment and retention. While the evidence supporting some of these strategies is deficient, addressing recruitment and retention issues with specific strategies will help researchers deal with these issues in their funding applications and in turn develop the necessary infrastructure to participate in emergency medicine clinical trials. PMID:21040112

  9. Can emergency medicine research benefit from adaptive design clinical trials?

    PubMed

    Flight, Laura; Julious, Steven A; Goodacre, Steve

    2017-04-01

    Adaptive design clinical trials use preplanned interim analyses to determine whether studies should be stopped or modified before recruitment is complete. Emergency medicine trials are well suited to these designs as many have a short time to primary outcome relative to the length of recruitment. We hypothesised that the majority of published emergency medicine trials have the potential to use a simple adaptive trial design. We reviewed clinical trials published in three emergency medicine journals between January 2003 and December 2013. We determined the proportion that used an adaptive design as well as the proportion that could have used a simple adaptive design based on the time to primary outcome and length of recruitment. Only 19 of 188 trials included in the review were considered to have used an adaptive trial design. A total of 154/165 trials that were fixed in design had the potential to use an adaptive design. Currently, there seems to be limited uptake in the use of adaptive trial designs in emergency medicine despite their potential benefits to save time and resources. Failing to take advantage of adaptive designs could be costly to patients and research. It is recommended that where practical and logistical considerations allow, adaptive designs should be used for all emergency medicine clinical trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  10. [Placebo control and clinical trial of Chinese medicine].

    PubMed

    Wu, Jing

    2010-10-01

    World Health Organization aims to develop safe, effective and practical traditional medicine. Traditional Chinese medicine (TCM) and other complementary and alternative medicine are being recognized in the whole world nowadays. However, the definite effect of Chinese medicine is still in need of scientific research proof. Placebo control is of equal importance to active control and blank control in clinical trial of TCM. This article briefly reviewed the importance of placebo control and commented on its present situation in clinical trial of TCM. This article also brought up the preliminary proposals of placebo application in TCM clinical trial. We should emphasize scientific placebo preparation and good design of placebo-controlled trial, which are directed by International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. A good clinical trial project will avoid unnecessary wastes and provide safe and effective treatment for people.

  11. Placebos used in clinical trials for Chinese herbal medicine.

    PubMed

    Qi, Guan D; We, Ding A; Chung, Leung P; Fai, Cheng K

    2008-06-01

    One of the important components in randomized Controlled Trial (RCT) is blinding. The gold standard of clinical trials is to achieve a double blind design. However, only a small number of randomized controlled trials in traditional Chinese medicine have been reported, most of them are of poor quality in methodology including placebo preparation and verification. The purpose of the article is to review the validity of placebo used in blinded clinical trials for Chinese herbal medicine (CHM) in recent years and related patents. We searched the Wanfang Database (total of 827 Chinese journals of medicine and/or pharmacy, from 1999 to 2005) and 598 full-length articles related to placebo clinical trials were found. 77 placebo blinded clinical trials for Chinese medicine were extracted by manual search from the 598 articles. After reviewing the 77 full-length articles, we found that nearly half of the clinical trials did not pay attention to the physical quality of the testing drug and placebo and whether they were of comparable physical quality. The rest provided very limited placebo information so that blinding assurance could not be assumed. Only 2 articles (2.6%) specifically validated the comparability between the testing drug and the placebo. Researchers in Chinese medicine commonly ignored the quality of the placebo in comparison to the test drug. This may be causing bias in the clinical trials. Quality specifications and evaluation of the placebo should deserve special attention to reduce bias in randomized controlled trials in TCM study.

  12. Randomized Trials in Emergency Medicine Journals, 2008-2011

    PubMed Central

    Jones, Christopher W.; Hunold, Katherine M.; Isaacs, Cameron G.; Platts-Mills, Timothy F.

    2012-01-01

    Study Objective Knowledge of current areas of activity in emergency medicine research may improve collaboration among investigators and may help inform decisions about future research priorities. Randomized controlled trials are a key component of research activity and an essential tool for improving care. We investigated the characteristics of randomized trials recently published in emergency medicine journals. Methods This was a retrospective analysis of randomized trials published in the five highest-impact emergency medicine journals. Pubmed was searched for reports of randomized trials involving human subjects indexed to MEDLINE between January 1, 2008 and December 31, 2011. Included trials were classified with respect to study topic, funding source, presence of age-related inclusion criteria, and country of origin. Results 163 published studies were included for analysis. Pain management was the most commonly studied topic (N=28, 17%) followed by orthopedics (N = 24, 15%), cardiovascular disease (N=13, 8%), and pre-hospital medicine (N=13, 8%). Less than half of studies received extramural funding support. Children were specifically examined in 22 (13%) of trials; only 5 trials (3%) specifically examined patients age 60 or older. Conclusions Emergency medicine journals publish randomized trials addressing a wide range of clinical topics. Randomized trials focusing on geriatric patients are not commonly published in these journals. PMID:22867836

  13. Active Clinical Trials for Personalized Medicine

    PubMed Central

    Minsker, Stanislav; Zhao, Ying-Qi; Cheng, Guang

    2016-01-01

    Individualized treatment rules (ITRs) tailor treatments according to individual patient characteristics. They can significantly improve patient care and are thus becoming increasingly popular. The data collected during randomized clinical trials are often used to estimate the optimal ITRs. However, these trials are generally expensive to run, and, moreover, they are not designed to efficiently estimate ITRs. In this article, we propose a cost-effective estimation method from an active learning perspective. In particular, our method recruits only the “most informative” patients (in terms of learning the optimal ITRs) from an ongoing clinical trial. Simulation studies and real-data examples show that our active clinical trial method significantly improves on competing methods. We derive risk bounds and show that they support these observed empirical advantages. Supplementary materials for this article are available online. PMID:28018014

  14. Stem cell trials for cardiovascular medicine: ethical rationale.

    PubMed

    Niemansburg, Sophie L; Teraa, Martin; Hesam, Husna; van Delden, Johannes J M; Verhaar, Marianne C; Bredenoord, Annelien L

    2014-10-01

    Stem cell-based interventions provide new treatment prospects for many disease conditions, including cardiovascular disorders. Clinical trials are necessary to collect adequate evidence on (long-term) safety and efficacy of novel interventions such as stem cells, but the design and launch of clinical trials, from first-in-human studies to larger randomized controlled trials (RCTs), is scientifically and ethically challenging. Stem cells are different from traditional pharmaceuticals, surgical procedures, and medical devices in the following ways: the novelty and complexity of stem cells, the invasiveness of the procedures, and the novel aim of regeneration. These specifics, combined with the characteristics of the study population, will have an impact on the design and ethics of RCTs. The recently closed JUVENTAS trial will serve as an example to identify the (interwoven) scientific and ethical challenges in the design and launch of stem cell RCTs. The JUVENTAS trial has investigated the efficacy of autologous bone marrow cells in end-stage vascular patients, in a double-blind sham-controlled design. We first describe the choices, considerations, and experiences of the JUVENTAS team. Subsequently, we identify the main ethical and scientific challenges and discuss what is important to consider in the design of future stem cell RCTs: assessment of risks and benefits, the choice for outcome measures, the choice for the comparator, the appropriate selection of participants, and adequate informed consent. Additionally, the stem cell field is highly in the spotlight due to the (commercial) interests and expectations. This warrants a cautious pace of translation and scrupulous set up of clinical trials, as failures could put the field in a negative light. At the same time, knowledge from clinical trials is necessary for the field to progress. We conclude that in the scientifically and ethically challenging field of stem cell RCTs, researchers and clinicians have to

  15. The Clinical Trials Network of the Society of Nuclear Medicine.

    PubMed

    Graham, Michael M

    2010-09-01

    The Clinical Trials Network of the Society of Nuclear Medicine was formed to provide quality assurance of both imaging and radiopharmaceutical manufacturing in clinical trials. The intention is to register and qualify a large number (>200) of sites, both in the United States and internationally, to be able to do the positron emission tomography imaging part of clinical trials. Initially, the types of trials to be supported include evaluation of novel radiopharmaceuticals and trials that use approved or experimental radiopharmaceuticals for early assessment of tumor response to novel chemotherapy agents. The Clinical Trials Network is organized into 7 committees that provide overall oversight and strategic guidance, database management, site qualification and monitoring, scanner validation, clinical site orientation, technologist education, trial design, and a manufacturer's registry. At the end of the first year, more than 200 potential clinical trial sites and more than 125 manufacturing sites have expressed interest in participating. The qualification process is well underway. Funding is being provided by 3 large pharmaceutical companies. An investigational new drug application has been obtained for F-18 fluorothymidine that is held by Society of Nuclear Medicine to allow simplification of data management during multisite trials with F-18 fluorothymidine. A second investigational new drug application is in preparation for F-18 fluoromisonidazole. A supply of oncology chest phantoms has been manufactured and have been shipped to numerous sites for scanner validation. Educational materials are being developed for the physicians, technologists, and research coordinators at the sites. This is an important initiative that is likely to help significantly expand the role of molecular imaging and will help bring the right treatment to the right patient at the right time. Copyright 2010 Elsevier Inc. All rights reserved.

  16. Prerequisites to launch neuroprotective trials in Parkinson's disease: an industry perspective.

    PubMed

    Streffer, Johannes R; Grachev, Igor D; Fitzer-Attas, Cheryl; Gomez-Mancilla, Baltazar; Boroojerdi, Babak; Bronzova, Juliana; Ostrowitzki, Susanne; Victor, Stephen J; Fontoura, Paulo; Alexander, Robert

    2012-04-15

    Realizing that 60% to 80% of dopaminergic nigrostriatal neurons are nonfunctional at the time of clinical diagnosis, there is an emerging consensus that disease-modifying treatments should be initiated in the earliest stages of Parkinson's disease (PD). To date, clinical trial designs and metrics in PD have been focused on motor symptoms as the core feature of the clinical disease. To identify earlier or "pre-motor" populations in PD, new markers have been proposed. We address the prerequisites needed to use these pre-motor markers in clinical trials for the selection of subjects, definition of populations, and monitoring of disease progression. This may require the development of new diagnostic criteria potentially based on non-motor clinical signs, imaging techniques, or biological features, all requiring discussion in a regulatory framework. Questions addressed include: Which steps must be taken to gain a broad consensus in the field from academic opinion leaders, patient advocacy groups, regulatory bodies, and industry? How do we prevent the selection of subgroups, which may not be representative of the full disease spectrum? Is there a way forward in personalized medicine? How do we balance risk and benefit in an at-risk population? While many tools are available, a concerted effort is required to develop integrated data sets, as well as to achieve the necessary standardization for multicenter clinical trials. To this end, public-private consortia (including academic centers, patient advocacy groups, and industry) will be of crucial importance to prospectively investigate and define the best tools and treatment paradigms.

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

    PubMed

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

    2016-01-01

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

  18. Evidence-based medicine: the design and interpretation of noninferiority clinical trials in veterinary medicine.

    PubMed

    Freise, K J; Lin, T-L; Fan, T M; Recta, V; Clark, T P

    2013-01-01

    Noninferiority trials are clinical studies designed to demonstrate that an investigational drug is at least as effective as an established treatment within a predetermined margin. They are conducted, in part, because of ethical concerns of administering a placebo to veterinary patients when an established effective treatment exists. The use of noninferiority trial designs has become more common in veterinary medicine with the increasing number of established veterinary therapeutics and the desire to eliminate potential pain or distress in a placebo-controlled study. Selecting the appropriate active control and an a priori noninferiority margin between the investigational and active control drug are unique and critical design factors for noninferiority studies. Without reliable historical knowledge of the disease response in the absence of treatment and of the response to the selected active control drug, proper design and interpretation of a noninferiority trial is not possible. Despite the appeal of conducting noninferiority trials to eliminate ethical concerns of placebo-controlled studies, there are real limitations and possible ethical conundrums associated with noninferiority trials. The consequences of incorrect study conclusions because of poor noninferiority trial design need careful attention. Alternative trial designs to typical noninferiority studies exist, but these too have limitations and must also be carefully considered.

  19. Quality of natural product clinical trials: a comparison of those published in alternative medicine versus conventional medicine journals.

    PubMed

    Cochrane, Zara Risoldi; Gregory, Philip; Wilson, Amy

    2011-06-01

    To compare the quality of natural product clinical trials published in alternative medicine journals versus those published in conventional medicine journals. Systematic search and review of the literature. Randomized controlled trials of natural products were included if they were published in English between 2003 and 2008. Articles were categorized by their journal of publication (alternative medicine versus conventional medicine). Two independent reviewers evaluated study quality using guidelines from the Cochrane Collaboration. The results with respect to the primary outcome (positive or negative) were also assessed. Thirty articles were evaluated, 15 published in alternative medicine journals and 15 in conventional medicine journals. Of articles published in alternative medicine journals, 33.33% (n = 5) were considered low quality, and none were considered high quality. Of articles published in conventional medicine journals, 26.67% (n = 4) were considered low quality and 6.67% (n = 1) were considered high quality. Two thirds of all trials reviewed were of unclear quality, due to inadequate reporting of information relating to the study's methodology. Similar proportions of positive and negative primary outcomes were found in alternative and conventional medicine journals, and low-quality articles were not more likely to report a positive primary outcome (Fisher's exact test, two-tailed p = .287). The quality of natural product randomized controlled trials was similar among alternative and conventional medicine journals. Efforts should be made to improve the reporting of natural product clinical trials for accurate determinations of study quality to be possible.

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

    PubMed

    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.

  1. The landscape of precision cancer medicine clinical trials in the United States.

    PubMed

    Roper, Nitin; Stensland, Kristian D; Hendricks, Ryan; Galsky, Matthew D

    2015-05-01

    Advances in tumor biology and multiplex genomic analysis have ushered in the era of precision cancer medicine. Little is currently known, however, about the landscape of prospective "precision cancer medicine" clinical trials in the U.S. We identified all adult interventional cancer trials registered on ClinicalTrials.gov between September 2005 and May 2013. Trials were classified as "precision cancer medicine" if a genomic alteration in a predefined set of 88 genes was required for enrollment. Baseline characteristics were ascertained for each trial. Of the initial 18,797 trials identified, 9094 (48%) were eligible for inclusion: 684 (8%) were classified as precision cancer medicine trials and 8410 (92%) were non-precision cancer medicine trials. Compared with non-precision cancer medicine trials, precision cancer medicine trials were significantly more likely to be phase II [RR 1.19 (1.10-1.29), p<0.001], multi-center [RR 1.18 (1.11-1.26), p<0.001], open-label [RR 1.04 (1.02-1.07), p=0.005] and involve breast [RR 4.03 (3.49-4.52), p<0.001], colorectal [RR 1.62 (1.22-2.14), p=0.002] and skin [RR 1.98 (1.55-2.54), p<0.001] cancers. Precision medicine trials required 38 unique genomic alterations for enrollment. The proportion of precision cancer medicine trials compared to the total number of trials increased from 3% in 2006 to 16% in 2013. The proportion of adult cancer clinical trials in the U.S. requiring a genomic alteration for enrollment has increased substantially over the past several years. However, such trials still represent a small minority of studies performed within the cancer clinical trials enterprise and include a small subset of putatively "actionable" alterations. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. An overview of the NCI precision medicine trials-NCI MATCH and MPACT.

    PubMed

    Do, Khanh; O'Sullivan Coyne, Geraldine; Chen, Alice P

    2015-09-01

    The concept of oncogene addiction was first proposed by Weinstein in 2002, postulating that tumors rely on a single dominant mutation, the oncogenic "driver", for growth and survival. We have since come to realize that the genomic landscape of tumors is heterogeneous and more complex than previously thought. Advances in biotechnology and bioinformatics over the past decade have shifted treatment paradigms with regard to the development of molecular targeted therapeutics to identify and target the presumptive dominant lesion. As such, the decision of choosing targeted treatment strategies has become increasingly more reliant on the reporting of genomic screens of patients' tumor tissue. Whether this change in treatment paradigm will translate into improved clinical benefit, remains to be seen. To this end, the United States National Cancer Institute (NCI) has launched precision-based medicine trials to address this question. NCI Molecular Analysis for Therapy Choice (MATCH), a genomic pre-screening study, was designed to explore the efficacy of using targeted agents to target specific molecular aberrations and whether these same therapies have comparable activity across different tumor subtypes. Molecular Profiling-based Assignment of Cancer Therapy (MPACT), is a smaller, provocative trial designed to address whether targeting an oncogenic "driver" would be more efficacious than one not. The Exceptional Responders' initiative further aims to evaluate patients who have derived an unexpected durable benefit to these therapies, with retrospective analysis of their tumors to delineate potential predictive biomarkers which could predict response. The results of these trials will serve to help guide the field of precision medicine and personalized care.

  3. Methodological Issues in Trials of Complementary and Alternative Medicine Interventions

    PubMed Central

    Sikorskii, Alla; Wyatt, Gwen; Victorson, David; Faulkner, Gwen; Rahbar, Mohammad Hossein

    2010-01-01

    Background Complementary and alternative medicine (CAM) use is widespread among cancer patients. Information on safety and efficacy of CAM therapies is needed for both patients and health care providers. Well-designed randomized clinical trials (RCTs) of CAM therapy interventions can inform both clinical research and practice. Objectives To review important issues that affect the design of RCTs for CAM interventions. Methods Using the methods component of the Consolidated Standards for Reporting Trials (CONSORT) as a guiding framework, and a National Cancer Institute-funded reflexology study as an exemplar, methodological issues related to participants, intervention, objectives, outcomes, sample size, randomization, blinding, and statistical methods were reviewed. Discussion Trials of CAM interventions designed and implemented according to appropriate methodological standards will facilitate the needed scientific rigor in CAM research. Interventions in CAM can be tested using proposed methodology, and the results of testing will inform nursing practice in providing safe and effective supportive care and improving the well-being of patients. PMID:19918155

  4. Chinese herbal medicine for idiopathic sudden sensorineural hearing loss: a systematic review of randomised clinical trials.

    PubMed

    Su, C-X; Yan, L-J; Lewith, G; Liu, J-P

    2013-12-01

    Idiopathic sudden sensorineural hearing loss has great impact on quality of life. Many clinical trials using Chinese herbal medicine for idiopathic sudden sensorineural hearing loss have been conducted and reported beneficial results. However, there is no critical appraised evidence on efficacy and safety of Chinese herbal medicine for idiopathic sudden sensorineural hearing loss to inform clinical use. To assess the beneficial effect and safety of Chinese herbal medicine for idiopathic sudden sensorineural hearing loss. Systematic review of randomised clinical trials. Seven electronic databases and two trial registries were searched for all eligible trials from inception to January 2013. Two authors independently selected trials and extracted data. The Cochrane risk of bias tool was utilised to assess the methodological quality of the included trials. revman 5.2 software was applied for data analysis with effect estimate presented as risk ratio and mean difference with its 95% confidence interval. Forty-one randomised clinical trials involving 3560 participants were identified. Five kinds of Chinese herbal medicine were trialed. All trials compared conventional therapies of steroids, vasodilators, anticoagulants, nutritional supplements or hyperbaric oxygen with or without herbal medicine. No trial was identified that compared herbal medicine alone with placebo. No trial was identified that blinded the participants or the observers to their herbal medication. Only one trial adequately reported its method of randomisation. No trial reported the sample size calculated to show an effect. All trials had material other defects giving a high likelihood of bias. Because of the overall poor quality of all 41 trials, it was concluded that there was no level-one evidence to support the use of Chinese herbal medicine, alone or in addition to conventional therapies, to improve the hearing in adults with idiopathic sudden sensorineural hearing loss. Two trials reported adverse

  5. Personalized Medicine Enrichment Design for DHA Supplementation Clinical Trial.

    PubMed

    Lei, Yang; Mayo, Matthew S; Carlson, Susan E; Gajewski, Byron J

    2017-03-01

    Personalized medicine aims to match patient subpopulation to the most beneficial treatment. The purpose of this study is to design a prospective clinical trial in which we hope to achieve the highest level of confirmation in identifying and making treatment recommendations for subgroups, when the risk levels in the control arm can be ordered. This study was motivated by our goal to identify subgroups in a DHA (docosahexaenoic acid) supplementation trial to reduce preterm birth (gestational age<37 weeks) rate. We performed a meta-analysis to obtain informative prior distributions and simulated operating characteristics to ensure that overall Type I error rate was close to 0.05 in designs with three different models: independent, hierarchical, and dynamic linear models. We performed simulations and sensitivity analysis to examine the subgroup power of models and compared results to a chi-square test. We performed simulations under two hypotheses: a large overall treatment effect and a small overall treatment effect. Within each hypothesis, we designed three different subgroup effects scenarios where resulting subgroup rates are linear, flat, or nonlinear. When the resulting subgroup rates are linear or flat, dynamic linear model appeared to be the most powerful method to identify the subgroups with a treatment effect. It also outperformed other methods when resulting subgroup rates are nonlinear and the overall treatment effect is big. When the resulting subgroup rates are nonlinear and the overall treatment effect is small, hierarchical model and chi-square test did better. Compared to independent and hierarchical models, dynamic linear model tends to be relatively robust and powerful when the control arm has ordinal risk subgroups.

  6. Herbal Medicines for Treating Metabolic Syndrome: A Systematic Review of Randomized Controlled Trials.

    PubMed

    Jang, Soobin; Jang, Bo-Hyoung; Ko, Youme; Sasaki, Yui; Park, Jeong-Su; Hwang, Eui-Hyoung; Song, Yun-Kyung; Shin, Yong-Cheol; Ko, Seong-Gyu

    2016-01-01

    Objective. The aim of this systematic review is to evaluate the efficacy and safety of herbal medicines in the management of metabolic syndrome. Materials and Methods. On December 9, 2015, we searched PubMed, EMBASE, Cochrane Library, SCOPUS, AMED, CNKI, KoreaMed, KMBASE, OASIS, and J-STAGE with no restriction on language or published year. We selected randomized controlled trials that involved patients with metabolic syndrome being treated with herbal medicines as intervention. The main keywords were "Chinese herbal medicines", "metabolic syndrome", and "randomized controlled trials". Herbal substances which were not based on East Asian medical theory, combination therapy with western medicines, and concurrent diseases other than metabolic syndrome were excluded. The risk of bias was assessed by Cochrane's "Risk of Bias" tool. The protocol or review was registered in PROSPERO (an international prospective register of systematic reviews) (CRD42014006842). Results. From 1,098 articles, 12 RCTs were included in this review: five trials studied herbal medicines versus a placebo or no treatment, and seven trials studied herbal medicines versus western medicines. Herbal medicines were effective on decreasing waist circumference, blood glucose, blood lipids, and blood pressure. Conclusion. This study suggests the possibility that herbal medicines can be complementary and alternative medicines for metabolic syndrome.

  7. Barriers towards the publication of academic drug trials. Follow-up of trials approved by the Danish Medicines Agency.

    PubMed

    Berendt, Louise; Petersen, Lene Grejs; Bach, Karin Friis; Poulsen, Henrik Enghusen; Dalhoff, Kim

    2017-01-01

    To characterize and quantify barriers towards the publication of academic drug trials. We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates of initiation, completion, and publication, and the reasons for the failure to reach each of these milestones. Information on size and methodological characteristics of the trials was extracted from the EudraCT database, a prospective register of all approved clinical drug trials submitted to European medicines agencies since 2004. A total of 181 academic drug trials were eligible for inclusion, 139 of which participated in our survey (response rate: 77%). Follow-up time ranged from 5.1 to 7.9 years. Most trials were randomized controlled trials (73%, 95% CI 65-81%). Initiation and completion rates were 92% (95% CI: 88-97%) and 93% (95% CI: 89-97%) respectively. The publication rate of completed trials was 73% (95% CI: 62-79%). RCTs were published faster than non-RCTs (quartile time to publication 2.9 vs. 3.1 years, p = 0.0412). Many academic drug trials are left unpublished. Main barriers towards publication were related to the process from completion to publication. Hence, there is much to gain by facilitating the process from analysis to publication. Research institutions and funders should actively influence this process, e.g. by requiring the publication of trial results within a given time after completion.

  8. Chinese herbal medicine for gout: a systematic review of randomized clinical trials.

    PubMed

    Li, Xin-Xue; Han, Mei; Wang, Yu-Yi; Liu, Jian-Ping

    2013-07-01

    Patients with gout referring to Chinese herbal medicine are not rare in China, and a great number of clinical trials on herbal medicine have been published. However, there has not been a systematic review to summarize the evidence of Chinese herbal medicine for gout. The aim of this study is to evaluate the evidence for the effectiveness and safety of Chinese herbal medicine for gout. We searched for randomized clinical trials on Chinese herbal medicine for gout till December 2012. Cochrane risk of bias tool was used to assess the methodological quality. RevMan 5.2 was used to synthesize the results. We included 57 trials involving 4,527 gout patients. The quality of trials was generally poor. No trial reported health-related quality of life in patients. There is not enough evidence showing that herbal medicine was statistically more effective than conventional medications in pain relief [mean difference (MD), -0.03; 95% confidence interval (CI), -0.06, 0.00], but herbal medicine combined with conventional medicines may have better effectiveness (MD, -0.33; 95% CI, -0.59, -0.07). Trials that reported function limitation relief found herbal medicine more effective than conventional medications (MD, -0.23; 95% CI, -0.32, -0.15). There was no evidence showing that herbal medicine prevents gout recurrence better. Twenty-five out of 41 trials, involving 23 different herbal prescriptions, found statistical significance in lowering serum uric acid level, and the overall effect from Chinese herbal medicine in inflammation relief is better than conventional therapies in 19 trials with 17 different prescriptions. The current data show that herbal medicine leads to fewer side reactions compared to conventional therapies [risk ratio (RR), 0.11; 95% CI, 0.08 to 0.15]. Chinese herbal medicine may have clinical effectiveness for functional recovery in patients with gout, and lead to a safe control of serum uric acid level and inflammation severity. Due to low quality of trials

  9. [Introduction trial of medicine mulberry (Morus nigra) in Chongqing].

    PubMed

    Zeng, Qi-Wei; Zhang, Chao; Chen, Hong-Yu; Ding, Tian-Long; Zhao, Ai-Chun; Xiang, Zhong-Huai; He, Ning-Jia

    2016-04-01

    Medicine mulberry (Morus nigra) mainly distributed in southern areas of Xinjiang Uighur Autonomous Region and introduced by grafting, is a unique Morus species, whose plant number is little. As a traditional herbal medicine, medicine mulberry with high levels of secondary metabolites has important values of scientific research and utilization. In order to solve the introduction problems for medicine mulberry, we have established its rapid propagation system through tissue culture since 2011. The shoots of medicine mulberry through tissue culture were transplanted into the field to carry out an introduction experiment. Here, we firstly reported that the growth status and pest and disease occurrence of medicine mulberry in the field of Chongqing and found that the medicine mulberry through tissue culture had well-developed root system, it showed better growth than medicine mulberry by grafting technique, and Pseudodendrothrips moil was a major pest of medicine mulberry. The introduction technique for medicine mulberry established successfully in this study could lay the foundation for large-scale cultivation and high efficiency utilization of medicine mulberry. Copyright© by the Chinese Pharmaceutical Association.

  10. [Defining trials of medicinal products according to the revised Dutch Medical Research in Human Subjects Act (WMO)].

    PubMed

    Vos, E J; Huitema, A D R

    2006-09-23

    The revised Dutch Medical Research in Human Subjects Act (WMO), which implements the European directive regarding 'good clinical practice in the conduct of clinical trials on medicinal products for human use' (2001/20/EC), became effective on March 1, 2006. The revision places additional requirements on trials of medicinal products. Whether a trial should be regarded as a trial of a medicinal product is therefore an important question. The law does not provide adequate guidance for the classification of trials in which biological samples are collected, e.g. for genomic, proteomic or pharmacokinetic studies, while a medicinal product is given for a registered indication. Classifying these types of trials as trials of medicinal products does not enhance the safety of the participants. Therefore, these studies should not be considered as trials of medicinal products to avoid the increased administrative burden required by the revised WMO.

  11. [New Royal Decree on clinical trials: main implications for emergency medicine physicians who do research].

    PubMed

    García Arenillas, Mar; Haj-Ali Saflo, Okba; Sáenz de Tejada, Marta

    2017-06-01

    The new European Union directives affecting clinical trials of medicines introduced important changes for Spain, leading to the publication of a Royal Decree regulating the conduct of clinical trials that went into effect in January 2016. The decree sets out the principles for complying with the EU directives, regulates the work of institutional review boards (IRBs) or ethics committees that review research proposals, introduces means to facilitate clinical research, and clarifies the role of the Spanish register of clinical trials, among other topics. This paper discusses the main changes that have been introduced, especially those intended to facilitate research, such as the new concepts of low intervention trial and noncommercial clinical research. These concepts may be particularly useful for clinical trials designed by emergency medicine physicians. We also comment on changes affecting vulnerable populations and the documents that must be presented to both the researchers' IRB and the Spanish Agency for Medicines and Health Care Products.

  12. Launching Invasive, First-in-Human Trials against Parkinson’s Disease: Ethical Considerations

    PubMed Central

    London, Alex John; Ravina, Bernard; Ramsay, Tim; Bernstein, Mark; Fine, Alan; Stahnisch, Frank W.

    2009-01-01

    The decision to initiate invasive, first-in-human trials involving Parkinson’s disease presents a vexing ethical challenge. Such studies present significant surgical risks, and high degrees of uncertainty about intervention risks and biological effects. We argue that maintaining a favorable risk-benefit balance in such circumstances requires a higher than usual degree of confidence that protocols will lead to significant direct and/or social benefits. One critical way of promoting such confidence is through the application of stringent evidentiary standards for preclinical studies. We close with a series of recommendations for strengthening the internal and external validity of preclinical studies, reducing their tendency toward optimism and publication biases, and improving the knowledge base used to design and evaluate preclinical studies. PMID:19672990

  13. Herbal Medicines for Treating Metabolic Syndrome: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Ko, Youme; Sasaki, Yui; Hwang, Eui-Hyoung; Song, Yun-Kyung; Shin, Yong-Cheol

    2016-01-01

    Objective. The aim of this systematic review is to evaluate the efficacy and safety of herbal medicines in the management of metabolic syndrome. Materials and Methods. On December 9, 2015, we searched PubMed, EMBASE, Cochrane Library, SCOPUS, AMED, CNKI, KoreaMed, KMBASE, OASIS, and J-STAGE with no restriction on language or published year. We selected randomized controlled trials that involved patients with metabolic syndrome being treated with herbal medicines as intervention. The main keywords were “Chinese herbal medicines”, “metabolic syndrome”, and “randomized controlled trials”. Herbal substances which were not based on East Asian medical theory, combination therapy with western medicines, and concurrent diseases other than metabolic syndrome were excluded. The risk of bias was assessed by Cochrane's “Risk of Bias” tool. The protocol or review was registered in PROSPERO (an international prospective register of systematic reviews) (CRD42014006842). Results. From 1,098 articles, 12 RCTs were included in this review: five trials studied herbal medicines versus a placebo or no treatment, and seven trials studied herbal medicines versus western medicines. Herbal medicines were effective on decreasing waist circumference, blood glucose, blood lipids, and blood pressure. Conclusion. This study suggests the possibility that herbal medicines can be complementary and alternative medicines for metabolic syndrome. PMID:27413388

  14. Evaluating traditional Chinese medicine using modern clinical trial design and statistical methodology: application to a randomized controlled acupuncture trial.

    PubMed

    Lao, Lixing; Huang, Yi; Feng, Chiguang; Berman, Brian M; Tan, Ming T

    2012-03-30

    Traditional Chinese medicine (TCM), used in China and other Asian counties for thousands of years, is increasingly utilized in Western countries. However, due to inherent differences in how Western medicine and this ancient modality are practiced, employing the so-called Western medicine-based gold standard research methods to evaluate TCM is challenging. This paper is a discussion of the obstacles inherent in the design and statistical analysis of clinical trials of TCM. It is based on our experience in designing and conducting a randomized controlled clinical trial of acupuncture for post-operative dental pain control in which acupuncture was shown to be statistically and significantly better than placebo in lengthening the median survival time to rescue drug. We demonstrate here that PH assumptions in the common Cox model did not hold in that trial and that TCM trials warrant more thoughtful modeling and more sophisticated models of statistical analysis. TCM study design entails all the challenges encountered in trials of drugs, devices, and surgical procedures in the Western medicine. We present possible solutions to some but leave many issues unresolved.

  15. [Features of Clinical Register of Chinese Medicine and Pharmacy Based on ClinicalTrials.gov. (USA)].

    PubMed

    Lu, Peng-fei; Liao, Xing; Xie, Yan-ming; Wang, Zhi-guo

    2015-11-01

    In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.

  16. Recruitment strategies in two Reproductive Medicine Network infertility trials

    PubMed Central

    Usadi, Rebecca S.; Diamond, Michael P.; Legro, Richard S.; Schlaff, William D.; Hansen, Karl R.; Casson, Peter; Christman, Gregory; Bates, G. Wright; Baker, Valerie; Seungdamrong, Aimee; Rosen, Mitchell P.; Lucidi, Scott; Thomas, Tracey; Huang, Hao; Santoro, Nanette; Eisenberg, Esther; Zhang, Heping; Alvero, Ruben

    2016-01-01

    Background Recruitment of individuals into clinical trials is a critical step in completing studies. Reports examining the effectiveness of different recruitment strategies, and specifically in infertile couples, are limited. Methods We investigated recruitment methods used in two NIH sponsored trials, Pregnancy in Polycystic Ovary Syndrome (PPCOS II) and Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS), and examined which strategies yielded the greatest number of participants completing the trials. Results 3683 couples were eligible for screening. 1650 participants were randomized and 1339 completed the trials. 750 women were randomized in PPCOS II; 212 of the participants who completed the trial were referred by physicians. Participants recruited from radio ads (84/750) and the internet (81/750) resulted in similar rates of trial completion in PPCOS II. 900 participants were randomized in AMIGOS. 440 participants who completed the trial were referred to the study by physicians. The next most successful method in AMIGOS was use of the internet, achieving 78 completed participants. Radio ads proved the most successful strategy in both trials for participants who earned <$50,000 annually. Radio ads were most successful in enrolling white patients in PPCOS II and black patients in AMIGOS. Seven ancillary Clinical Research Scientist Training (CREST) sites enrolled 324 of the participants who completed the trials. Conclusions Physician referral was the most successful recruitment strategy. Radio ads and the internet were the next most successful strategies, particularly for women of limited income. Ancillary clinical sites were important for overall recruitment. PMID:26386293

  17. Registration status and outcome reporting of trials published in core headache medicine journals.

    PubMed

    Rayhill, Melissa L; Sharon, Roni; Burch, Rebecca; Loder, Elizabeth

    2015-11-17

    To evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals. We identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications. The journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness. Only about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue. © 2015 American Academy of Neurology.

  18. Quality of registration for clinical trials published in emergency medicine journals.

    PubMed

    Jones, Christopher W; Platts-Mills, Timothy F

    2012-10-01

    In 2005, the International Committee of Medical Journal Editors established clinical trial registration as a requirement for articles submitted to member journals, with the goal of improving the transparency of clinical research. The objective of this study is to characterize the registration of clinical trials published in emergency medicine journals. Randomized trials involving human subjects and published between June 1, 2008, and May 31, 2011 in the 5 emergency medicine journals with the highest impact factors were included. We assessed the clarity of registered primary outcomes, timing of registration relative to patient enrollment, and consistency between registered and published outcomes. Of the 123 trials included, registry entries were identified for 57 (46%). Of the 57 registered studies, 45 (79%) were registered after the initiation of subject enrollment, 9 (16%) had registered outcomes that were unclear, and 26 (46%) had discrepancies between registered and published outcomes. Only 5 studies were registered before patient enrollment with a clear primary outcome that was consistent with the published primary outcome. Annals of Emergency Medicine was the only journal in which the majority of trials were registered. Current compliance with clinical trial registration guidelines is poor among trials published in emergency medicine journals. Copyright © 2012. Published by Mosby, Inc.

  19. Study protocol for a cluster-randomised controlled trial of an NCD access to medicines initiative: evaluation of Novartis Access in Kenya

    PubMed Central

    Rockers, Peter C; Wirtz, Veronika J; Vian, Taryn; Onyango, Monica A; Ashigbie, Paul G; Laing, Richard

    2016-01-01

    Introduction Novartis recently launched Novartis Access, an initiative to provide a basket of reduced price medicines for non-communicable diseases (NCDs) to be sold through the public and private non-profit sectors in programme countries. This study will evaluate the impact of Novartis Access on the availability and price of NCD medicines at health facilities and households in Kenya, the first country to receive the programme. Methods and analysis This study will be a cluster-randomised controlled trial. 8 counties in Kenya will be randomly assigned to the intervention or control group using a covariate constrained randomisation method to maximise balance on demographic and health characteristics. In intervention counties, public and private non-profit health facilities will be able to order Novartis Access NCD medicines from the Mission for Essential Drugs and Supplies (MEDS). Data will be collected from a random sample of 384 health facilities and 800 households at baseline, midline after 1-year of intervention, and end-line after 2 years. Quarterly surveillance data will also be collected from health facilities and a subsample of households through phone-based interviews. Households will be eligible if at least one resident has been previously diagnosed and prescribed a medicine for an NCD addressed by Novartis Access, including hypertension and diabetes. The primary outcomes will be availability and price of NCD medicines at health facilities, and availability, price, and expenditures on NCD medicines at households. Impacts will be estimated using intention-to-treat analysis. Ethics and dissemination This protocol was approved by the Institutional Review Boards at Strathmore University and at Boston University. Informed consent will be obtained from all participants at the start of the trial. The findings of the trial will be disseminated through peer-reviewed journals, international conferences, and meetings and events organised with local stakeholders

  20. [Harmonization procedures directed toward clinical trials in laboratory medicine at the National Cancer Center Hospital].

    PubMed

    Ozeki, Mitsuru; Shioya, Kana; Furuta, Koh

    2009-09-01

    Recent advances in pharmacology and molecular sciences made it possible to develop drugs for patients with various maladies. Frustration has existed concerning the delayed provision of these drugs for routine practices in the clinical field. To correct this problem, the importance of clinical trials is increasing. Although there exists a strong demand for participation of clinical laboratories in clinical trials, an awkward attitude in clinical laboratories frustrates those performing clinical trials. We are attempting to correct this problem by introducing our experience with harmonization procedures directed toward clinical trials in laboratory medicine in general. First we described the current status of clinical trials in our hospital. Then we will show personnel in need for clinical trials. Finally we describe in detail our clinical trial procedures. We focus particularly on three aspects of participation in clinical trials: pre-analytical, analytical, and post analytical. Additionally we describe the problems and perspectives in clinical trials by giving special reference to the clinical laboratories in general through discussion with various personnel and specialists. Our goal in the field of laboratory medicine is to benefit patients through the establishment of a harmony between clinical trials and clinical laboratories.

  1. The need for precision medicine clinical trials in childhood asthma: rationale and design of the PUFFIN trial.

    PubMed

    Vijverberg, Susanne Jh; Pijnenburg, Mariëlle W; Hövels, Anke M; Koppelman, Gerard H; Maitland-van der Zee, Anke-Hilse

    2017-03-01

    A 'one-size fits all'-approach does not fit all pediatric asthma patients. Current evidence suggests that in children with persistent asthma, ADRB2 genotype-guided treatment can improve treatment outcomes, yet this evidence is mainly derived from observational and genotype-stratified studies. Implementation of precision medicine-guided asthma treatment in clinical practice will only occur if randomized clinical trials can show that this approach will improve patient outcomes and is cost effective. In this paper, we will discuss why precision medicine trials are currently needed to improve childhood asthma management and present the rationale and design of the PUFFIN trial, that has been set up to address this need.

  2. Bibliometric and content analysis of the Cochrane Complementary Medicine Field specialized register of controlled trials

    PubMed Central

    2013-01-01

    Background The identification of eligible controlled trials for systematic reviews of complementary and alternative medicine (CAM) interventions can be difficult. To increase access to these difficult to locate trials, the Cochrane Collaboration Complementary Medicine Field (CAM Field) has established a specialized register of citations of CAM controlled trials. The objective of this study is to describe the sources and characteristics of citations included in the CAM Field specialized register. Methods Between 2006 and 2011, regular searches for citations of CAM trials in MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL) were supplemented with contributions of controlled trial citations from international collaborators. The specialized register was ‘frozen’ for analysis in 2011, and frequencies were calculated for publication date, language, journal, presence in MEDLINE, type of intervention, and type of medical condition. Results The CAM Field specialized register increased in size from under 5,000 controlled trial citations in 2006 to 44,840 citations in 2011. Most citations (60%) were from 2000 or later, and the majority (71%) were reported in English; the next most common language was Chinese (23%). The journals with the greatest number of citations were CAM journals published in Chinese and non-CAM nutrition journals published in English. More than one-third of register citations (36%) were not indexed in MEDLINE. The most common CAM intervention type in the register was non-vitamin, non-mineral dietary supplements (e.g., glucosamine, fish oil) (34%), followed by Chinese herbal medicines (e.g., Astragalus membranaceus, Schisandra chinensis) (27%). Conclusions The availability of the CAM Field specialized register presents both opportunities and challenges for CAM systematic reviewers. While the register provides access to thousands of difficult to locate trial citations, many of these trials are of low quality and may overestimate

  3. Precision Medicine Clinical Trials: Defining New Treatment Strategies

    PubMed Central

    Heckman-Stoddard, Brandy M.; Smith, Judith J.

    2014-01-01

    Objectives To discuss the role of clinical trials in the changing landscape of cancer care resulting in individualized cancer treatment plans including a discussion of several innovative randomized studies designed to evaluate multiple targeted therapies in molecularly defined subsets of individuals. Data Sources Medical and nursing literature, research articles, and clinicaltrials.gov. Conclusion Recent advancements in cancer biomarkers and biomedical technology have begun to transform fundamentals of cancer therapeutics and clinical trials through innovative adaptive trial designs. The goal of these studies is to learn not only if a drug is safe and effective but also how it is best delivered and who will derive the most benefit. Implications for Nursing Practice Implementation of clinical trials in the cancer biomarker era requires knowledge, skills, and expertise related to the use of biomarkers and molecularly defined processes underlying a malignancy, as well as an understanding of associated ethical, legal, and social issues to provide competent, safe, and effective health care and patient communication. PMID:24794084

  4. Large Cancer Drug Trial Helps Move Precision Medicine Toward the Mainstream | Poster

    Cancer.gov

    A landmark cancer drug trial is helping set the stage for moving precision medicine into the mainstream of clinical practice, according to a new study. The study, reported in the Journal of Molecular Diagnostics, validates a procedure used in the drug trial that identifies the unique genetic mutations in a patient’s tumor, which is then used as the basis for selecting targeted drugs for treatment.

  5. Evaluation of complementary and alternative medicine trials registered in clinicaltrials.gov database.

    PubMed

    Dizdar, Omer; Bilgin, Emre; Akin, Serkan; Kilickap, Saadettin; Hayran, Mutlu

    2017-01-01

    Complementary and alternative medicine (CAM) products are increasingly used because they are perceived as natural, relatively low-cost and probably effective therapies for various diseases including cancer. We aimed to determine the quantity and major characteristics of recent herbal/alternative medicine trials registered in clinicaltrials. gov in patients with cancer. "Cancer AND (herbal OR complementary OR alternative)" key words were used to query clinicaltrials. gov (access date 17 April 2015). From the results, 163 trials which have been conducted in patients with the diagnosis of cancer were identified and included in this analysis. At the date of access, 72 trials were completed, 37 trials were still recruiting patients and 10 trials had been withdrawn. Most common cancer type was breast cancer. Eighty-eight percent of trials were interventional and 60% of trials were randomized. The rate of new trial submission were similar for 5-year periods after 2000. The majority of the trials were conducted in United States of America (55%) and People's Republic of China (11%). Nine and 4 of 37 recruiting trials were recorded as phase II and phase III, respectively. When browsing was restricted to "recruiting" and "interventional" studies, the ratio of herbal/complementary treatment trials to all chemotherapy trials was 1.8 %. CAM research in patients with cancer is currently limited, both in terms of quantity and quality. Until high quality scientific and clinical research establishes safety and efficacy of CAM practices, physicians should rigorously inform patients and the public on potential risks and caveats associated with CAM practices.

  6. Clinical Trials of Precision Medicine through Molecular Profiling: Focus on Breast Cancer.

    PubMed

    Zardavas, Dimitrios; Piccart-Gebhart, Martine

    2015-01-01

    High-throughput technologies of molecular profiling in cancer, such as gene-expression profiling and next-generation sequencing, are expanding our knowledge of the molecular landscapes of several cancer types. This increasing knowledge coupled with the development of several molecularly targeted agents hold the promise for personalized cancer medicine to be fully realized. Moreover, an expanding armamentarium of targeted agents has been approved for the treatment of specific molecular cancer subgroups in different diagnoses. According to this paradigm, treatment selection should be dictated by the specific molecular aberrations found in each patient's tumor. The classical clinical trials paradigm of patients' eligibility being based on clinicopathologic parameters is being abandoned, with current clinical trials enrolling patients on the basis of specific molecular aberrations. New, innovative trial designs have been generated to better tackle the multiple challenges induced by the increasing molecular fragmentation of cancer, namely: (1) longitudinal cohort studies with or without downstream trials, (2) studies assessing the clinical utility of molecular profiling, (3) master or umbrella trials, (4) basket trials, (5) N-of-1 trials, and (6) adaptive design trials. This article provides an overview of the challenges for clinical trials in the era of molecular profiling of cancer. Subsequently, innovative trial designs with respective examples and their potential to expedite efficient clinical development of targeted anticancer agents is discussed.

  7. Integrative medicine for subacute stroke rehabilitation: a study protocol for a multicentre, randomised, controlled trial

    PubMed Central

    Fang, Jianqiao; Chen, Lifang; Chen, Luni; Wang, Chao; Keeler, Crystal Lynn; Ma, Ruijie; Xu, Shouyu; Shen, Laihua; Bao, Yehua; Ji, Conghua

    2014-01-01

    Introduction Many patients with stroke receive integrative medicine in China, which includes the basic treatment of Western medicine and routine rehabilitation, in conjunction with acupuncture and Chinese medicine. The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation. Methods and analysis 360 participants recruited from three large Chinese medical hospitals in Zhejiang Province will be randomly divided into the integrative medicine rehabilitation (IMR) group and the conventional rehabilitation (CR) group in a 1:1 ratio. Participants in the IMR group will receive acupuncture and Chinese herbs in addition to basic Western medicine and rehabilitation treatment. The CR group will not receive acupuncture and Chinese herbal medicine. The assessment data will be collected at baseline, 4 and 8 weeks postrandomisation, and then at 12 weeks’ follow-up. The primary outcome is measured by the Modified Barthel Index. The secondary outcomes are the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment, the mini-mental state examination and Montreal Cognitive, Hamilton's Depression Scale and Self-Rating Depression Scale, and the incidence of adverse events. Ethics and dissemination Ethical approval was obtained from ethics committees of three hospitals. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone, during follow-up calls inquiring on patient's post-study health status. Trial registration number Chinese Clinical Trial Register: ChiCTR-TRC-12001972, http://www.chictr.org/en/proj/show.aspx?proj=2561 PMID:25475247

  8. THE CASE OF VERTEBROPLASTY TRIALS: PROMOTING A CULTURE OF EVIDENCE-BASED PROCEDURAL MEDICINE

    PubMed Central

    Miller, Franklin G.; Kallmes, David F.

    2010-01-01

    Two independent, randomized controlled trials of vertebroplasty for the relief of pain associated with vertebral fractures demonstrated that this procedure was no better than a sham intervention. Publication of the trial results prompted strong, critical commentaries by practitioners and professional societies. In this article we offer a psychological explanation of this dismissive response to rigorous scientific evidence, which appeals to the “placebo reactions” of physicians when dramatic improvement is noted in patients’ symptoms following administration of invasive procedures. We argue that the story of the response to the vertebroplasty trials underscores the need to develop a culture of evidence-based procedural medicine. PMID:20938382

  9. Large Cancer Drug Trial Helps Move Precision Medicine Toward the Mainstream | FNLCR

    Cancer.gov

    A landmark cancer drug trial is helping set the stage for moving precision medicine into the mainstream of clinical practice, according to a new study. The study, reported in the Journal of Molecular Diagnostics, validates a procedure used in the dru

  10. Large Cancer Drug Trial Helps Move Precision Medicine Toward the Mainstream | FNLCR Staging

    Cancer.gov

    A landmark cancer drug trial is helping set the stage for moving precision medicine into the mainstream of clinical practice, according to a new study. The study, reported in the Journal of Molecular Diagnostics, validates a procedure used in the dru

  11. The proposed EU-regulation on clinical trials on medicinal products: an unethical proposal?

    PubMed

    Heringa, Jilles; Dute, Joseph

    2013-09-01

    The Commission has proposed a regulation 'on clinical trials on medicinal products for human use' to introduce one regulatory framework for clinical trials in the European Union. This regulation should replace the current clinical trials directive (2001/20/EC). In this article we describe and critically review the main provisions of the proposed regulation. We assess the consequences for a sound authorisation procedure of clinical trials and the level of protection for human subjects. We note that the proposed regulation is inconsistent with applicable international legal documents, such as the Biomedicine Convention and the Declaration of Helsinki. We conclude that the proposed regulation does not ensure a "high level of human health protection"--required by its legal basis in the TFEU--because it may force Member States concerned to accept a reporting Member States' approval of--in their estimation--an unethical clinical trial.

  12. Herbal medicines for treating tic disorders: a systematic review of randomised controlled trials.

    PubMed

    Kim, Yun Hee; Son, Chang-Gue; Ku, Bon-Cho; Lee, Hye Won; Lim, Hyun Sook; Lee, Myeong Soo

    2014-02-07

    It was reported that 64% of tic disorder patients used complementary and alternative medicine. This review aims to evaluate the efficacy of herbal medicines in treating tic disorders. We searched eight databases including MEDLINE and CINAHL from their respective inceptions up to September 2013. The search terms were related to the concept of "herbal medicine" AND "tic disorder OR Tourette's syndrome". We included randomised controlled trials (RCTs) of any type of herbal medicines. We assessed the methodological quality of the trials according to the Cochrane risk of bias criteria. Sixty one studies were identified, and four RCTs met the inclusion criteria. Two types of herbal medicines, Qufeng Zhidong Recipe (QZR) decoction and Ningdong (ND) granules, were used in the included RCTs. All four RCTs had a high risk of bias. Two RCTs tested the effects of QZR on the Yale Global Tic Severity Scale (YGTSS) score and response rate compared with conventional medicine. The meta-analysis showed significant effects of QZR on the YGTSS score with high statistical heterogeneity (n = 142; weighted mean difference: -18.34; 95% confidence interval (CI): -23.07 to -13.60; I2 = 97%) and the response rate (n = 142; risk ratio: 1.69; 95% CI: 1.39 to 2.06; I2 = 0%). One RCT compared ND granules with placebo and showed significant effects on the YGTSS score and response rate. The other RCT show significant effects of ND granules plus conventional medicine on the response rate compared with conventional medicine only. This systematic review provided first piece of limited meta-analytic evidence for the effectiveness of herbal medicines in improving the symptoms of tic disorders.

  13. Participation of older people in preauthorization trials of recently approved medicines.

    PubMed

    Beers, Erna; Moerkerken, Dineke C; Leufkens, Hubert G M; Egberts, Toine C G; Jansen, Paul A F

    2014-10-01

    To investigate the inclusion of older people in clinical trials of recently authorized medicines, evaluating adherence to the 20-year-old International Conference of Harmonisation (ICH) guideline on geriatrics (E7). Observational. European public assessment reports, published clinical trials, World Health Organization International Clinical Trials Registry Platform. Individuals aged 65 and older and 75 and older. Number and proportion of randomized participants and all exclusion criteria of studies involving diseases characteristically associated with aging (venous thromboembolism, osteoporosis, atrial fibrillation) and diseases not unique to older adults (type 2 diabetes mellitus, depression, bipolar disorder, epilepsy). In 114 Phase II and III trials of 12 medicines, 43.1% of participants were aged 65 and older, and 16.1% were aged 75 and older. In trials involving diseases characteristically associated with ageing, 57% were aged 65 and older; 22% were aged 75 and older. In trials involving diseases not unique to old age, 9% were aged 65 and older, and 1% were aged 75 and older. Upper age limits were applied in 30.7% of the trials; the frequency did not differ between larger (sample size ≥ 500) and smaller trials (P = .36), although it was significantly lower in trials involving diseases characteristically associated with aging (18.0%) than in trials of diseases not unique to old age (45.3%; P = .002). Age-sensitive exclusion criteria, based on comorbidity (75.4%), concomitant medication (71.9%), and other criteria correlated with age (60.5%) were applied more frequently in larger trials (P < .02). Studies of diseases not uniquely associated with old age included an unacceptably low proportion of older people, contrary to the recommendations of the ICH E7 guideline. Although the proportion of older participants in trials of diseases characteristically associated with aging was appropriate for certain medicines, the use of age-sensitive exclusion criteria limits

  14. [50 years of clinical trials; a new direction in medicine].

    PubMed

    Van Gijn, J

    1999-01-02

    In 1998 the medical community commemorated the completion of the first truly randomised trial, the Medical Research Council Streptomycin Study. This invention is at least as important as Harrison's clocks, which in the 18th century solved the problem of measuring longitude at sea. Naturally the idea of randomised controls had evolved from previous notions. Obtaining informed consent remains essentially a matter between patient and physician, but in the meantime four other interested parties have joined in: governing bodies, the pharmaceutical industry, medical journals, and the mass media. In order to keep all these forces in check, lawmakers should protect the weakest parties against the more powerful ones. There is a great deal to be done in the next 50 years.

  15. Curcumin: From ancient medicine to current clinical trials

    PubMed Central

    Hatcher, H.; Planalp, R.; Cho, J.; Torti, S. V.

    2015-01-01

    Curcumin is the active ingredient in the traditional herbal remedy and dietary spice turmeric (Curcuma longa). Curcumin has a surprisingly wide range of beneficial properties, including anti-inflammatory, antioxidant, chemopreventive and chemotherapeutic activity. The pleiotropic activities of curcumin derive from its complex chemistry as well as its ability to influence multiple signaling pathways, including survival pathways such as those regulated by NF-κB, Akt, and growth factors; cytoprotective pathways dependent on Nrf2; and metastatic and angiogenic pathways. Curcumin is a free radical scavenger and hydrogen donor, and exhibits both pro- and antioxidant activity. It also binds metals, particularly iron and copper, and can function as an iron chelator. Curcumin is remarkably non-toxic and exhibits limited bioavailability. Curcumin exhibits great promise as a therapeutic agent, and is currently in human clinical trials for a variety of conditions, including multiple myeloma, pancreatic cancer, myelodysplastic syndromes, colon cancer, psoriasis and Alzheimer’s disease. PMID:18324353

  16. Integrative medicine for subacute stroke rehabilitation: a study protocol for a multicentre, randomised, controlled trial.

    PubMed

    Fang, Jianqiao; Chen, Lifang; Chen, Luni; Wang, Chao; Keeler, Crystal Lynn; Ma, Ruijie; Xu, Shouyu; Shen, Laihua; Bao, Yehua; Ji, Conghua

    2014-12-04

    Many patients with stroke receive integrative medicine in China, which includes the basic treatment of Western medicine and routine rehabilitation, in conjunction with acupuncture and Chinese medicine. The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation. 360 participants recruited from three large Chinese medical hospitals in Zhejiang Province will be randomly divided into the integrative medicine rehabilitation (IMR) group and the conventional rehabilitation (CR) group in a 1:1 ratio. Participants in the IMR group will receive acupuncture and Chinese herbs in addition to basic Western medicine and rehabilitation treatment. The CR group will not receive acupuncture and Chinese herbal medicine. The assessment data will be collected at baseline, 4 and 8 weeks postrandomisation, and then at 12 weeks' follow-up. The primary outcome is measured by the Modified Barthel Index. The secondary outcomes are the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment, the mini-mental state examination and Montreal Cognitive, Hamilton's Depression Scale and Self-Rating Depression Scale, and the incidence of adverse events. Ethical approval was obtained from ethics committees of three hospitals. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone, during follow-up calls inquiring on patient's post-study health status. Chinese Clinical Trial Register: ChiCTR-TRC-12001972, http://www.chictr.org/en/proj/show.aspx?proj=2561. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence

  17. Herbal medicines for treating tic disorders: a systematic review of randomised controlled trials

    PubMed Central

    2014-01-01

    Background It was reported that 64% of tic disorder patients used complementary and alternative medicine. This review aims to evaluate the efficacy of herbal medicines in treating tic disorders. Methods We searched eight databases including MEDLINE and CINAHL from their respective inceptions up to September 2013. The search terms were related to the concept of “herbal medicine” AND “tic disorder OR Tourette’s syndrome”. We included randomised controlled trials (RCTs) of any type of herbal medicines. We assessed the methodological quality of the trials according to the Cochrane risk of bias criteria. Results Sixty one studies were identified, and four RCTs met the inclusion criteria. Two types of herbal medicines, Qufeng Zhidong Recipe (QZR) decoction and Ningdong (ND) granules, were used in the included RCTs. All four RCTs had a high risk of bias. Two RCTs tested the effects of QZR on the Yale Global Tic Severity Scale (YGTSS) score and response rate compared with conventional medicine. The meta-analysis showed significant effects of QZR on the YGTSS score with high statistical heterogeneity (n = 142; weighted mean difference: −18.34; 95% confidence interval (CI): −23.07 to −13.60; I2 = 97%) and the response rate (n = 142; risk ratio: 1.69; 95% CI: 1.39 to 2.06; I2 = 0%). One RCT compared ND granules with placebo and showed significant effects on the YGTSS score and response rate. The other RCT show significant effects of ND granules plus conventional medicine on the response rate compared with conventional medicine only. Conclusion This systematic review provided first piece of limited meta-analytic evidence for the effectiveness of herbal medicines in improving the symptoms of tic disorders. PMID:24507013

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

    PubMed

    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.

  19. Statistical issues and limitations in personalized medicine research with clinical trials.

    PubMed

    Rubin, Daniel B; van der Laan, Mark J

    2012-07-20

    We discuss using clinical trial data to construct and evaluate rules that use baseline covariates to assign different treatments to different patients. Given such a candidate personalization rule, we first note that its performance can often be evaluated without actually applying the rule to subjects, and a class of estimators is characterized from a statistical efficiency standpoint. We also point out a recently noted reduction of the rule construction problem to a classification task and extend results in this direction. Together these facts suggest a natural form of cross-validation in which a personalized medicine rule can be constructed from clinical trial data using standard classification tools and then evaluated in a replicated trial. Because replication is often required by the FDA to provide evidence of safety and efficacy before pharmaceutical drugs can be marketed, there are abundant data with which to explore the potential benefits of more tailored therapy. We constructed and evaluated personalized medicine rules using simulations based on two active-controlled randomized clinical trials of antibacterial drugs for the treatment of skin and skin structure infections. Unfortunately we present negative results that did not suggest benefit from personalization. We discuss the implications of this finding and why statistical approaches to personalized medicine problems will often face difficult challenges.

  20. Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges.

    PubMed

    Oyama, M A; Ellenberg, S S; Shaw, P A

    2017-07-01

    Randomized clinical trials (RCTs) are among the most rigorous ways to determine the causal relationship between an intervention and important clinical outcome. Their use in veterinary medicine has become increasingly common, and as is often the case, with progress comes new challenges. Randomized clinical trials yield important answers, but results from these studies can be unhelpful or even misleading unless the study design and reporting are carried out with care. Herein, we offer some perspective on several emerging challenges associated with RCTs, including use of composite endpoints, the reporting of different forms of risk, analysis in the presence of missing data, and issues of reporting and safety assessment. These topics are explored in the context of previously reported veterinary internal medicine studies as well as through illustrative examples with hypothetical data sets. Moreover, many insights germane to RCTs in veterinary internal medicine can be drawn from the wealth of experience with RCTs in the human medical field. A better understanding of the issues presented here can help improve the design, interpretation, and reporting of veterinary RCTs. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  1. Treatment Algorithms Based on Tumor Molecular Profiling: The Essence of Precision Medicine Trials.

    PubMed

    Le Tourneau, Christophe; Kamal, Maud; Tsimberidou, Apostolia-Maria; Bedard, Philippe; Pierron, Gaëlle; Callens, Céline; Rouleau, Etienne; Vincent-Salomon, Anne; Servant, Nicolas; Alt, Marie; Rouzier, Roman; Paoletti, Xavier; Delattre, Olivier; Bièche, Ivan

    2016-04-01

    With the advent of high-throughput molecular technologies, several precision medicine (PM) studies are currently ongoing that include molecular screening programs and PM clinical trials. Molecular profiling programs establish the molecular profile of patients' tumors with the aim to guide therapy based on identified molecular alterations. The aim of prospective PM clinical trials is to assess the clinical utility of tumor molecular profiling and to determine whether treatment selection based on molecular alterations produces superior outcomes compared with unselected treatment. These trials use treatment algorithms to assign patients to specific targeted therapies based on tumor molecular alterations. These algorithms should be governed by fixed rules to ensure standardization and reproducibility. Here, we summarize key molecular, biological, and technical criteria that, in our view, should be addressed when establishing treatment algorithms based on tumor molecular profiling for PM trials. © The Author 2015. Published by Oxford University Press.

  2. Treatment Algorithms Based on Tumor Molecular Profiling: The Essence of Precision Medicine Trials

    PubMed Central

    Le Tourneau, Christophe; Kamal, Maud; Tsimberidou, Apostolia-Maria; Bedard, Philippe; Pierron, Gaëlle; Callens, Céline; Rouleau, Etienne; Vincent-Salomon, Anne; Servant, Nicolas; Alt, Marie; Rouzier, Roman; Paoletti, Xavier; Delattre, Olivier; Bièche, Ivan

    2016-01-01

    With the advent of high-throughput molecular technologies, several precision medicine (PM) studies are currently ongoing that include molecular screening programs and PM clinical trials. Molecular profiling programs establish the molecular profile of patients’ tumors with the aim to guide therapy based on identified molecular alterations. The aim of prospective PM clinical trials is to assess the clinical utility of tumor molecular profiling and to determine whether treatment selection based on molecular alterations produces superior outcomes compared with unselected treatment. These trials use treatment algorithms to assign patients to specific targeted therapies based on tumor molecular alterations. These algorithms should be governed by fixed rules to ensure standardization and reproducibility. Here, we summarize key molecular, biological, and technical criteria that, in our view, should be addressed when establishing treatment algorithms based on tumor molecular profiling for PM trials. PMID:26598514

  3. Management of Pneumothorax in Emergency Medicine Departments: Multicenter Trial

    PubMed Central

    Ince, Abdulkadir; Ozucelik, Dogac Niyazi; Avci, Akkan; Nizam, Ozgur; Dogan, Halil; Topal, Mehmet Ali

    2013-01-01

    Background: Pneumothorax is common and life-threatening clinical condition which may require emergency treatment in Emergency Medicine Departments. Objectives: We aimed to reveal the epidemiological analysis of the patients admitted to the Emergency Department with pneumothorax. Material and Methods: This case-control and multi-center study was conducted in the patients treated with the diagnosis of pneumothorax between 01.01.2010-31.12.2010. Patient data were collected from hospital automation system. According to the etiology of the pneumothorax, study groups were arranged like spontaneous pneumothorax and traumatic pneumothorax. Results: 82.2% (n = 106) of patients were male and 17.8% (n = 23) of patients were female and mean age were 31.3 ± 20,2 (Minimum: 1, Maximum: 87). 68.2% (n = 88) of patients were spontaneous pneumothorax (61.36%, n=79 were primary spontaneous pneumothorax) and 31.8% (n = 41) of patients were traumatic pneumothorax (21.95% were iatrogenic pneumothorax). Main complaint is shortness of breath (52.3%, n=67) and 38% (n=49) of patients were smokers. Posteroanterior (PA) Chest X-Ray has been enough for 64.3% (n = 83) of the patients' diagnosis. Tube thoracostomy is applied to 84.5% (n = 109) of patients and surgery is applied to 9.3% (n = 12) of patients and 6.2% (n = 8) of patients were discharged with conservative treatment. Spontaneous pneumothorax showed statistically significant high recurrence compared with traumatic pneumothorax (P = 0.007). 4.65% of (n = 6) patients died. The average age of those who died (9.3 ± 19.9), statistically were significantly lower the mean age of living patients (32.4 ± 19.7) (t test, P = 0,006). 83.33% of the patients who died were neonatals and in the 0-1 years age group, and five of these patients were secondary spontaneous pneumothorax, and one of these patients were iatrogenic pneumothorax due to mechanical ventilation. Conclusions: Pneumothorax in adults can be treated by tube thoracostomy or

  4. Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2012.

    PubMed

    Rawal, Bina; Deane, Bryan R

    2015-01-01

    The objective of this study was to assess the timely disclosure of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2012. This is an extension of the previously reported study of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, which found that over three-quarters of all these trials were disclosed within 12 months and almost 90% were disclosed by the end of the study. The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2012, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2014. The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2014 (end of survey). Of the completed trials associated with 23 new medicines licensed to 17 different companies in 2012, results of 90% (307/340) had been disclosed within 12 months, and results of 92% (312/340) had been disclosed by 31 July 2014. The disclosure rate within 12 months of 90% suggests the industry is now achieving disclosure in a timely manner more consistently than before. The overall disclosure rate at study end of 92% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated with new medicines approved in 2012.

  5. Chinese Herbal Medicine for Osteoporosis: A Meta-analysis of Randomized Controlled Trials.

    PubMed

    Jin, Yong-Xiang; Wu, Peng; Mao, Yi-Fan; Wang, Bo; Zhang, Jia-Feng; Chen, Wen-Liang; Liu, Zhong; Shi, Xiao-Lin

    2017-09-08

    Osteoporosis is a major public health problem in the elderly population. Several studies have suggested that Chinese herbal medicine has antiosteoporotic activities that might be beneficial for osteoporosis. This study aimed to assess the effectiveness of Chinese herbal medicine in osteoporosis patients. We comprehensively searched for randomized controlled trials (until December 2016) that compared Chinese herbal medicine with Western medicine in adults with osteoporosis and reported bone mineral densities (BMDs). A total of 10 randomized controlled trials were included. The pooled results suggested that the increased spine BMD was lower but not significant in the Chinese herbal medicine group than in the Western drug group (standard mean difference [SMD] = -0.11, 95% confidence interval [CI]: -0.62 to 0.39, p > 0.05). In the subgroup analysis, in postmenopausal women, Chinese herbal medicine also showed a insignificantly higher increment in BMD than the control group (SMD = 0.22, 95% CI: -0.00 to 0.43, p = 0.05). For different treatment durations, subgroups over 6 mo (SMD = 0.09, 95% CI: -0.24 to 0.41, p > 0.05) and less than 6 mo (SMD = -0.25, 95% CI: -1.14 to 0.64, p > 0.05) showed comparable BMDs between the 2 therapies. Our study demonstrated that Chinese herbal medicine alone did not significantly increase lumbar spine BMD. Further studies with better adherence to the intervention are needed to confirm the results of this meta-analysis. Copyright © 2017 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.

  6. European society of intensive care medicine study of therapeutic hypothermia (32-35°C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial)

    PubMed Central

    2011-01-01

    Background Traumatic brain injury is a major cause of death and severe disability worldwide with 1,000,000 hospital admissions per annum throughout the European Union. Therapeutic hypothermia to reduce intracranial hypertension may improve patient outcome but key issues are length of hypothermia treatment and speed of re-warming. A recent meta-analysis showed improved outcome when hypothermia was continued for between 48 hours and 5 days and patients were re-warmed slowly (1°C/4 hours). Previous experience with cooling also appears to be important if complications, which may outweigh the benefits of hypothermia, are to be avoided. Methods/design This is a pragmatic, multi-centre randomised controlled trial examining the effects of hypothermia 32-35°C, titrated to reduce intracranial pressure <20 mmHg, on morbidity and mortality 6 months after traumatic brain injury. The study aims to recruit 1800 patients over 41 months. Enrolment started in April 2010. Participants are randomised to either standard care or standard care with titrated therapeutic hypothermia. Hypothermia is initiated with 20-30 ml/kg of intravenous, refrigerated 0.9% saline and maintained using each centre's usual cooling technique. There is a guideline for detection and treatment of shivering in the intervention group. Hypothermia is maintained for at least 48 hours in the treatment group and continued for as long as is necessary to maintain intracranial pressure <20 mmHg. Intracranial hypertension is defined as an intracranial pressure >20 mmHg in accordance with the Brain Trauma Foundation Guidelines, 2007. Discussion The Eurotherm3235Trial is the most important clinical trial in critical care ever conceived by European intensive care medicine, because it was launched and funded by the European Society of Intensive Care Medicine and will be the largest non-commercial randomised controlled trial due to the substantial number of centres required to deliver the target number of patients. It

  7. A National Cancer Clinical Trials Network: Recommendations from the Institute of Medicine

    PubMed Central

    Nass, Sharyl J.; Balogh, Erin; Mendelsohn, John

    2010-01-01

    Oncology has become one of the most active areas of drug discovery, with more than 800 cancer therapeutics in development. This presents an unprecedented opportunity to improve the outcome for patients with cancer, but also requires an effective and efficient clinical trials network to generate the evidence necessary for regulatory approval and optimal integration of new treatments into clinical care. The Clinical Trials Cooperative Group Program supported by the National Cancer Institute has been instrumental in establishing standards of care in oncology over the last 50 years, but it currently faces numerous challenges that threaten its ability to undertake the large-scale, multi-institutional trials that advance patient care. The Institute of Medicine recently appointed a consensus study committee to assess the organization and operation of the Cooperative Group Program and recommend ways to improve the quality of cancer clinical trials conducted by the Groups and others. The committee developed a set of recommendations, summarized here, that aim to improve the speed and efficiency of trials; incorporate innovative science and trial design; improve prioritization, selection, and support of trials; and increase participation by patients and physicians. PMID:21326081

  8. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine?

    PubMed Central

    Lillie, Elizabeth O; Patay, Bradley; Diamant, Joel; Issell, Brian; Topol, Eric J; Schork, Nicholas J

    2011-01-01

    N-of-1 or single subject clinical trials consider an individual patient as the sole unit of observation in a study investigating the efficacy or side-effect profiles of different interventions. The ultimate goal of an n-of-1 trial is to determine the optimal or best intervention for an individual patient using objective data-driven criteria. Such trials can leverage study design and statistical techniques associated with standard population-based clinical trials, including randomization, washout and crossover periods, as well as placebo controls. Despite their obvious appeal and wide use in educational settings, n-of-1 trials have been used sparingly in medical and general clinical settings. We briefly review the history, motivation and design of n-of-1 trials and emphasize the great utility of modern wireless medical monitoring devices in their execution. We ultimately argue that n-of-1 trials demand serious attention among the health research and clinical care communities given the contemporary focus on individualized medicine. PMID:21695041

  9. Risk indicator taxonomy for supervision of clinical trials on medicinal products.

    PubMed

    Jongen, Peter M J M; van den Bogert, Cornelis A; van de Laar, Catharina W E; Notenboom, Kim; Hille, Elysée T M; Hegger, Ingrid

    2016-07-01

    To facilitate a risk-based approach for the supervision of clinical trials on medicinal products, we identified and categorized indicators that may present an elevated safety and/or ethical risk for participants, and/or for data integrity. The indicators are relevant for all stakeholders including participants, regulatory bodies, health care inspectorates, sponsors and trial sites. The sources of indicators included Medline (using the search terms risk-based/-triggered/-driven oversight/monitoring/inspection), relevant documents from websites of regulatory authorities in Europe, North America and Australia, and results of a brainstorm session organized for experts working in the field. Indicators were classified according to risk area (safety and ethical, data integrity, or both). In total, we identified 69 risk indicators that were categorized into six branch-levels of the taxonomy. We visualized the taxonomy in a tree structure to clearly distinguish individual indicators. In addition to readily detectable risk indicators, more context-related aspects determine the final impact of the trial and constitute further components in risk assessment. Context-related aspects include potential high media attention, consequences for the reputation of medical research, and the socioeconomic situation in the geographic region and have to be considered on a case-by-case basis. We identified a wide array of risk indicators for clinical trials on medicinal products and we used a tree structure to incorporate the indicators identified to clearly distinguish individual indicators and to enable efficient use of the indicators. The overview of indicators may facilitate multiple stakeholders in developing structured risk assessment (identification and analysis) for supervising clinical trials on medicinal products. Stakeholders can interpret and prioritize the indicators from their own perspective.

  10. European society of intensive care medicine study of therapeutic hypothermia (32-35 °C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial).

    PubMed

    Andrews, Peter J D; Sinclair, Helen Louise; Battison, Claire G; Polderman, Kees H; Citerio, Giuseppe; Mascia, Luciana; Harris, Bridget A; Murray, Gordon D; Stocchetti, Nino; Menon, David K; Shakur, Haleema; De Backer, Daniel

    2011-01-12

    Traumatic brain injury is a major cause of death and severe disability worldwide with 1,000,000 hospital admissions per annum throughout the European Union.Therapeutic hypothermia to reduce intracranial hypertension may improve patient outcome but key issues are length of hypothermia treatment and speed of re-warming. A recent meta-analysis showed improved outcome when hypothermia was continued for between 48 hours and 5 days and patients were re-warmed slowly (1 °C/4 hours). Previous experience with cooling also appears to be important if complications, which may outweigh the benefits of hypothermia, are to be avoided. This is a pragmatic, multi-centre randomised controlled trial examining the effects of hypothermia 32-35 °C, titrated to reduce intracranial pressure <20 mmHg, on morbidity and mortality 6 months after traumatic brain injury. The study aims to recruit 1800 patients over 41 months. Enrolment started in April 2010.Participants are randomised to either standard care or standard care with titrated therapeutic hypothermia. Hypothermia is initiated with 20-30 ml/kg of intravenous, refrigerated 0.9% saline and maintained using each centre's usual cooling technique. There is a guideline for detection and treatment of shivering in the intervention group. Hypothermia is maintained for at least 48 hours in the treatment group and continued for as long as is necessary to maintain intracranial pressure <20 mmHg. Intracranial hypertension is defined as an intracranial pressure >20 mmHg in accordance with the Brain Trauma Foundation Guidelines, 2007. The Eurotherm3235Trial is the most important clinical trial in critical care ever conceived by European intensive care medicine, because it was launched and funded by the European Society of Intensive Care Medicine and will be the largest non-commercial randomised controlled trial due to the substantial number of centres required to deliver the target number of patients. It represents a new and fundamental step for

  11. A Pilot Whole Systems Clinical Trial of Traditional Chinese Medicine and Naturopathic Medicine for the Treatment of Temporomandibular Disorders

    PubMed Central

    Hammerschlag, Richard; Calabrese, Carlo; Mist, Scott; Aickin, Mikel; Sutherland, Elizabeth; Leben, Joseph; DeBAR, Lynn; Elder, Charles; Dworkin, Samuel F.

    2008-01-01

    Abstract Objectives To assess the feasibility and acceptability of studying whole systems of Traditional Chinese Medicine (TCM) and Naturopathic medicine (NM) in the treatment of temporomandibular disorders (TMD), and to determine whether there is indication to support further research. Design A pilot study using a randomized controlled clinical trial design of whole system TCM and NM versus state-of-the-art specialty care (SC). Setting/location Kaiser Permanente Northwest (KPNW), and practitioner offices in Portland, Oregon. Subjects One hundred and sixty (160) women 25–55 years of age attending a KPNW TMD specialty clinic. Interventions Whole system TCM and NM, and KPNW TMD clinic SC; the intervention protocols were designed to model the individually tailored type of community care offered in alternative medicine practices in Portland and in the KPNW TMD clinic, using protocols that enhanced similarities among practitioners within each system and permitted full descriptions of the treatments provided. Outcome measures TMD was ascertained using the Research Diagnostic Criteria/TMD; outcomes were self-reported worst and average facial pain and interference with activities (scaled 0–10 where 10 is worst). Results Of 948 consecutive eligible patients, 160 were randomized to one of three arms; 128 provided endpoint data. TCM and NM demonstrated significantly greater in-treatment reductions for worst facial pain compared to SC (adjusted regression analysis; higher negative values indicate greater improvement, = −1.11 ± 0.43, p = 0.010 and −1.02 ± 0.45, p = 0.025 for TCM and NM, respectively, compared to SC) and at 3 months post-treatment (−1.07 ± 0.51, p = 0.037 and −1.27 ± 0.54, p = 0.019 for TCM and NM versus SC, respectively). Additionally, TCM provided significantly greater decreases in average pain than SC; NM provided significantly greater decreases than SC or TCM in TMD-related psychosocial interference

  12. Traditional Chinese Medicine for Treatment of Fibromyalgia: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Cao, Huijuan; Lewith, George T.

    2010-01-01

    Abstract Background Traditional Chinese Medicine (TCM) is popular for treatment of fibromyalgia (FM) although there is a lack of comprehensive evaluation of current clinical evidence for TCM's therapeutic effect and safety. Objective To review systematically the beneficial and harmful effects of TCM therapies for FM. Methods We searched six English and Chinese electronic databases for randomized clinical trials (RCTs) on TCM for treatment of FM. Two authors extracted data and assessed the trial quality independently. RevMan 5 software was used for data analyses with an effect estimate presented as mean difference (MD) with a 95% confidence interval (CI). Results Twenty-five RCTs were identified with 1516 participants for this review. Seven trials (28%) were evaluated as having a low risk of bias and the remaining trials were identified as being as unclear or having a high risk of bias. Overall, ten trials were eligible for the meta-analysis, and data from remaining 15 trials were synthesized qualitatively. Acupuncture reduced the number of tender points (MD, –3.21; 95% CI –4.23 to –2.11; p < 0.00001, I2 = 0%), and pain scores compared with conventional medications (MD, –1.78; 95% CI, –2.24 to –1.32; p < 0.00001; I2 = 0%). Acupuncture showed no significant effect, with a random-effect model, compared with sham acupuncture (MD, –0.55; 95% CI, –1.35–0.24; p = 0.17; I2 = 69%), on pain reduction. A combination of acupuncture and cupping therapy was better than conventional medications for reducing pain (MD, –1.66; 95% CI, –2.14 to –1.19; p < 0.00001; I2 = 0%), and for improving depression scores with related to FM (MD, –4.92; 95% CI, –6.49 to –3.34; p < 0.00001; I2 = 32%). Other individual trials demonstrated positive effects of Chinese herbal medicine on pain reduction compared with conventional medications. There were no serious adverse effects reported that were related to TCM therapies in these

  13. Traditional Chinese Medicine for treatment of fibromyalgia: a systematic review of randomized controlled trials.

    PubMed

    Cao, Huijuan; Liu, Jianping; Lewith, George T

    2010-04-01

    Traditional Chinese Medicine (TCM) is popular for treatment of fibromyalgia (FM) although there is a lack of comprehensive evaluation of current clinical evidence for TCM's therapeutic effect and safety. To review systematically the beneficial and harmful effects of TCM therapies for FM. We searched six English and Chinese electronic databases for randomized clinical trials (RCTs) on TCM for treatment of FM. Two authors extracted data and assessed the trial quality independently. RevMan 5 software was used for data analyses with an effect estimate presented as mean difference (MD) with a 95% confidence interval (CI). Twenty-five RCTs were identified with 1516 participants for this review. Seven trials (28%) were evaluated as having a low risk of bias and the remaining trials were identified as being as unclear or having a high risk of bias. Overall, ten trials were eligible for the meta-analysis, and data from remaining 15 trials were synthesized qualitatively. Acupuncture reduced the number of tender points (MD, -3.21; 95% CI -4.23 to -2.11; p < 0.00001, I(2) = 0%), and pain scores compared with conventional medications (MD, -1.78; 95% CI, -2.24 to -1.32; p < 0.00001; I(2) = 0%). Acupuncture showed no significant effect, with a random-effect model, compared with sham acupuncture (MD, -0.55; 95% CI, -1.35-0.24; p = 0.17; I(2) = 69%), on pain reduction. A combination of acupuncture and cupping therapy was better than conventional medications for reducing pain (MD, -1.66; 95% CI, -2.14 to -1.19; p < 0.00001; I(2) = 0%), and for improving depression scores with related to FM (MD, -4.92; 95% CI, -6.49 to -3.34; p < 0.00001; I(2) = 32%). Other individual trials demonstrated positive effects of Chinese herbal medicine on pain reduction compared with conventional medications. There were no serious adverse effects reported that were related to TCM therapies in these trials. TCM therapies appear to be effective for treating FM. However, further large, rigorously designed

  14. A Systematic Review of Randomized Controlled Trials on Oral Chinese Herbal Medicine for Prostate Cancer

    PubMed Central

    Li, Xun; Wang, Yuyi; Chen, Shiuan; Liu, Jian-ping

    2016-01-01

    Background Prostate cancer is the most common malignant tumor associated with male reproductive system. Objective The existing eligible randomized controlled trials (RCTs) were critically appraised for the safety and effectiveness of CHM for prostate cancer. Methods A literature search was conducted by using PubMed, CENTRAL, CNKI, CBM, VIP and Wanfang databases until August 2015. RCTs of CHM or CHM plus conventional medicine for prostate cancer patients were included. The primary outcomes appraised were survival time, time to progression and quality of life. The risk of bias assessment according to the Cochrane Handbook was used to evaluate the methodological quality of the included trials. Revman 5.3 software was used for data analyses. Risk ratio and mean difference (MD) with a 95% confidence interval (CI) were used as effect measures. Meta-analysis was to be used if sufficient trials without obvious clinical or statistical heterogeneity were available. Results A total of 17 RCTs involving 1224 participants were analyzed. One trial was about CHM comparing to no treatment. The remaining 16 trials used CHMs as adjunctive treatment for endocrine therapy. Due to the poor quality of methodologies of most trials, only limited evidence showed that a combination of CHM and endocrine therapy might be more effective in restraining the development of the disease (MD 10.37 months, 95%CI 9.10 to 11.63 months), increasing patients’ survival time (7–15 months) or improving patients’ performance status, when compared to endocrine therapy alone (Karnofsky performance scale average changed 15 scores between groups). No severe adverse event was reported related to CHM. Conclusion Due to the insufficient quality of trials that were analyzed, it is not appropriate to recommend any kind of CHMs in treating prostate cancer at the present time. Well-designed trials with high methodological quality are needed to validate the effect of CHMs for patients with prostate cancer. PMID

  15. Topical herbal medicines for atopic eczema: a systematic review of randomized controlled trials.

    PubMed

    Thandar, Y; Gray, A; Botha, J; Mosam, A

    2017-02-01

    Despite the availability of medicines with proven efficacy, many patients use complementary or alternative medicines (CAMs) to manage atopic eczema (AE). Due to the lack of objective information on topical CAMs, this systematic review evaluates the current evidence for the efficacy and safety of topical herbal preparations in AE. Using Cochrane systematic review methodology, PubMed, the Cochrane Library, the Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL (via EBSCO), MEDLINE (via EBSCO), Proquest Health and Medical Complete, GREAT and CAM-QUEST were searched from inception until June 2014. Bibliographies of retrieved studies were hand searched for further relevant trials. All controlled clinical trials of topical herbal medicines for AE in humans of any age were included regardless of the control intervention or randomization. Only English-language publications were considered. Eight studies met the inclusion criteria. Seven investigated extracts of single plants and one an extract from multiple plants. Only two studies that showed a positive effect were considered to have a low risk of bias across all domains (those of liquorice gel and Hypericum perforatum). In these two, the test product was reported to be superior to placebo. Despite variations in diagnostic criteria and lack of validated tools for outcome assessments in one of these, the promising results may warrant continued research in better-designed studies. No meta-analysis was performed due to heterogeneity in all studies. There is currently insufficient evidence of efficacy for any topical herbal extract in AE. Many studies had methodological flaws and even those showing efficacy were single trials with small patient cohorts. © 2016 British Association of Dermatologists.

  16. Efficacy and safety of Ayurvedic medicines: Recommending equivalence trial design and proposing safety index.

    PubMed

    Sarmukaddam, Sanjeev; Chopra, Arvind; Tillu, Girish

    2010-07-01

    Ayurvedic drugs have begun to be evaluated in controlled clinical trials. The trials, often placebo controlled, are usually designed to demonstrate superiority. Though the results have been usually reported as encouraging, statistical significance has been elusive. In this melee to show efficacy, several positive results related to safety and other purported advantages with Ayurvedic drugs, including improved quality of life, easy drug availability and less cost, get drowned. Though safety is the prime concern, efficacy ultimately matters in trials. Excellent safety profile offset modest efficacy, especially for long-term management of chronic difficult to treat disorders. There is a trade-off between efficacy and safety but we have no means to put them together in a mathematical evaluation to judge the overall performance of a drug. However, we need more suitable modern science methods/techniques to unravel the true therapeutic role of Ayurvedic drugs. We propose "equivalence trials" using modern medicine benchmark as a comparator and a "safety/tolerability index" on this perspective. We believe that several Ayurvedic drugs are capable of demonstrating equal efficacy but superior safety. Our concept may also be applicable for pragmatic trials that are more suitable for Ayurvedic therapy.

  17. Challenges and Recommendations for Placebo Controls in Randomized Trials in Physical and Rehabilitation Medicine

    PubMed Central

    Fregni, Felipe; Imamura, Marta; Chien, Hsin Fen; Lew, Henry L.; Boggio, Paulo; Kaptchuk, Ted J; Riberto, Marcelo; Hsing, Wu Tu; Battistella, Linamara Rizzo; Furlan, Andrea

    2010-01-01

    Compared to other specialties, the field of Physical and Rehabilitation Medicine (PRM) has not received the deserved recognition from clinicians and researchers in the scientific community. One of the reasons is the lack of sound evidence to support the traditional PRM treatments. The best way to change this disadvantage is through well-conducted clinical research, such as the standard placebo or sham-controlled randomized clinical trials. Therefore, having placebo groups in clinical trials is essential to improve the level of evidence-based practice in PRM that ultimately translates in a better clinical care. To address the challenges for the use of placebo in PRM randomized clinical trials, and to create useful recommendations, we convened a working group during the inaugural International Symposium in Placebo (February 2009, in Sao Paulo, Brazil) in which the following topics were discussed: (1) current status of randomized clinical trials in PRM, (2) challenges for the use of placebo in PRM, (3) bioethical issues, (4) use of placebo in acupuncture trials and for the treatment of low-back pain, (5) mechanisms of placebo, and (6) insights from other specialties. The current article represents the consensus report from the working group. PMID:20090428

  18. Evidence-based medicine training during residency: a randomized controlled trial of efficacy

    PubMed Central

    2010-01-01

    Background Evidence-based medicine (EBM) has been widely integrated into residency curricula, although results of randomized controlled trials and long term outcomes of EBM educational interventions are lacking. We sought to determine if an EBM workshop improved internal medicine residents' EBM knowledge and skills and use of secondary evidence resources. Methods This randomized controlled trial included 48 internal medicine residents at an academic medical center. Twenty-three residents were randomized to attend a 4-hour interactive workshop in their PGY-2 year. All residents completed a 25-item EBM knowledge and skills test and a self-reported survey of literature searching and resource usage in their PGY-1, PGY-2, and PGY-3 years. Results There was no difference in mean EBM test scores between the workshop and control groups at PGY-2 or PGY-3. However, mean EBM test scores significantly increased over time for both groups in PGY-2 and PGY-3. Literature searches, and resource usage also increased significantly in both groups after the PGY-1 year. Conclusions We were unable to detect a difference in EBM knowledge between residents who did and did not participate in our workshop. Significant improvement over time in EBM scores, however, suggests EBM skills were learned during residency. Future rigorous studies should determine the best methods for improving residents' EBM skills as well as their ability to apply evidence during clinical practice. PMID:20807453

  19. 02A. Design, Methods, and Outcomes for Recent Clinical Trials Utilizing Ayurvedic Medicine, Yoga, and Meditation

    PubMed Central

    Saper, Robert; Vinjamury, Sivarama; Elder, Charles

    2013-01-01

    Focus Area: Integrative Approaches to Care The panel discussants will present on the outcomes of four recent pragmatic trials covering the spectrum of Ayurvedic medicine, yoga, and meditation as therapeutic approaches for both acute and chronic conditions. The presenters will discuss: (1) a pilot study of a whole-systems Ayurveda and Yoga Therapy intervention for obesity; (2) a comparative effectiveness randomized controlled trial of hatha yoga, physical therapy, and education for non-specific chronic low back pain in low-income minority populations; (3) an investigation of the therapeutic usefulness of Shirodhara (Ayurvedic oil dripping therapy) as a treatment for insomnia; and (4) a discussion of the evidence base supporting implementation of meditation interventions in schools and workplace settings. Discussants will present information on study designs, research methodology, and outcome measure selection to highlight special considerations in conducting research on whole medical systems that use multi-target therapies and focus on patient-centered outcomes. Ayurvedic medicine and yoga are characterized by low-cost, noninvasive interventions that can be usefully offered as part of an integrative medicine therapeutic approach.

  20. CUPID: a protocol of a randomised controlled trial to identify characteristics of similar Chinese patent medicines

    PubMed Central

    Cao, Hongbo; Zhai, Jingbo; Li, Nan; Cao, Hongxia; Lei, Xiang; Mu, Wei; Liu, Zhi; Wang, Hui; Shang, Hongcai

    2014-01-01

    Introduction Traditional Chinese medicine (TCM) has accumulated some experience in curing stable angina pectoris (SAP) and efficacy has been demonstrated. Chinese patent medicines, known as modern dosage forms of TCM, can attain the desired effect in clinical application only with the guidance of TCM syndrome theory. However, due to their use by a large number of persons with little knowledge of TCM theories and practices, their efficacy and reputation have been seriously affected. Method and analysis Two common syndrome types of SAP in TCM, ‘qi deficiency and blood stasis’ and ‘qi stagnation and blood stasis’, will be studied in 144 subjects from four TCM hospitals in Tianjin in China using a partial crossover design. The two syndromes will be broken down into six symptom combinations; patients will select a combination of the most distressing to them, and then will be randomised into two groups. Each group, on the basis of routine medication, will be administered one kind of Chinese patent drug: Qishenyiqi Dripping Pills or Compound Danshen Dripping Pills. The treatment characteristics of the two medicines will be evaluated with the COME-PIO method developed by our research team. Ethics and dissemination This protocol has been approved by the medical ethics committee of Tianjin University of TCM (registration number TJUTCM-EC20130005). The study is safe and reliable. Trial registration number Chinese clinical trials register ChiCTR-TTRCC-14004406. PMID:25431225

  1. Personalised and Precision Medicine in Cancer Clinical Trials: Panacea for Progress or Pandora's Box?

    PubMed

    Lawler, Mark; Sullivan, Richard

    2015-01-01

    Cancer clinical trials have been one of the key foundations for significant advances in oncology. However, there is a clear recognition within the academic, care delivery and pharmaceutical/biotech communities that our current model of clinical trial discovery and development is no longer fit for purpose. Delivering transformative cancer care should increasingly be our mantra, rather than maintaining the status quo of, at best, the often miniscule incremental benefits that are observed with many current clinical trials. As we enter the era of precision medicine for personalised cancer care (precision and personalised medicine), it is important that we capture and utilise our greater understanding of the biology of disease to drive innovative approaches in clinical trial design and implementation that can lead to a step change in cancer care delivery. A number of advances have been practice changing (e.g. imatinib mesylate in chronic myeloid leukaemia, Herceptin in erb-B2-positive breast cancer), and increasingly we are seeing the promise of a number of newer approaches, particularly in diseases like lung cancer and melanoma. Targeting immune checkpoints has recently yielded some highly promising results. New algorithms that maximise the effectiveness of clinical trials, through for example a multi-stage, multi-arm type design are increasingly gaining traction. However, our enthusiasm for the undoubted advances that have been achieved are being tempered by a realisation that these new approaches may have significant cost implications. This article will address these competing issues, mainly from a European perspective, highlight the problems and challenges to healthcare systems and suggest potential solutions that will ensure that the cost/value rubicon is addressed in a way that allows stakeholders to work together to deliver optimal cost-effective cancer care, the benefits of which can be transferred directly to our patients.

  2. Qualitative systemic review of randomized controlled trials on complementary and alternative medicine treatments in fibromyalgia.

    PubMed

    Baranowsky, Julia; Klose, Petra; Musial, Frauke; Häuser, Winfried; Haeuser, Winfried; Dobos, Gustav; Langhorst, Jost

    2009-11-01

    The objectives of the study were identification, quality evaluation and summary of RCTs on complementary and alternative medicine as defined by the National Institute of Health with the exception of dietary and nutritional supplements. A computerized search of databases from 1990 (year of publication of the ACR criteria for fibromyalgia) to July 2007 was performed. The RCTs were assessed by a methodological quality score. A total of 23 RCTs issued from 1992 to 2007 on acupuncture, balneotherapy, thermotherapy, magnetic therapy, homeopathy, manual manipulation, mind-body medicine, diet therapy and music therapy were identified. The RCTs had an average group size of 25 with the number of groups ranging from two to four. The quality score assessment of the RCTs yielded a mean score of 51 out of 100. The average methodological quality of the identified studies was fairly low. Best evidence was found for balneotherapy/hydrotherapy in multiple studies. Positive results were also noted for homeopathy and mild infrared hyperthermia in 1 RCT in each field. Mindfulness meditation showed mostly positive results in two trials and acupuncture mixed results in multiple trials with a tendency toward positive results. Tendencies for improvement were furthermore noted in single trials of the Mesendieck system, connective tissue massage and to some degree for osteopathy and magnet therapy. No positive evidence could be identified for Qi Gong, biofeedback, and body awareness therapy.

  3. Protocol for a randomised controlled trial evaluating the effects of providing essential medicines at no charge: the Carefully seLected and Easily Accessible at No Charge Medicines (CLEAN Meds) trial.

    PubMed

    Persaud, Nav; Lee, Taehoon; Ahmad, Haroon; Li, Winny; Taglione, Michael Sergio; Rajakulasingam, Yathavan; Umali, Norman; Boozary, Andrew; Glazier, Richard H; Gomes, Tara; Hwang, Stephen W; Jüni, Peter; Law, Michael; Mamdani, Muhammad M; Manns, Braden; Martin, Danielle; Morgan, Steve; Oh, Paul; Pinto, Andrew David; Shah, Baiju R; Sullivan, Frank M; Thorpe, Kevin E; Tu, Karen; Laupacis, Andreas

    2017-06-12

    Cost-related non-adherence to medicines is common in low-income, middle-income and high-income countries such as Canada. Medicine non-adherence is associated with poor health outcomes and increased mortality. This randomised trial will test the impact of a carefully selected list of essential medicines at no charge (compared with usual medicine access) in primary care patients reporting cost-related non-adherence. This is an open-label, parallel two-arm, superiority, individually randomised controlled trial conducted in three primary care sites (one urban, two rural) in Ontario, Canada, that was codesigned by a community guidance panel. Adult patients (≥18 years) who report cost-related non-adherence to medicines are eligible to participate in the study. Participants will be randomised to receive free and convenient access to a carefully selected list of 125 essential medicines (based on the WHO's Model List of Essential Medicines) or usual means of medicine access. Care for patients in both groups will otherwise be unchanged. The primary outcome of this trial is adherence to appropriately prescribed medicines. Secondary outcomes include medicine adherence, appropriate prescribing, blood pressure, haemoglobin A1c, low-density lipoprotein cholesterol, patient-oriented outcomes and healthcare costs. All participants will be followed for at least 12 months. Ethics approval was obtained in all three participating sites. Results of the main trial and secondary outcomes will be submitted for publication in a peer-reviewed journal and discussed with members of the public and decision makers. NCT02744963. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  4. Clinical trial transparency: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved recently in Europe.

    PubMed

    Rawal, Bina; Deane, Bryan R

    2014-03-01

    Previous studies have raised concerns around the transparency and disclosure rates of clinical trial results on clinical trial registries and in the scientific literature. The objective of this study was to assess the timely disclosure in the public domain of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) over a recent 3 year period. The study surveyed various publicly available information sources for both clinical trial registration and disclosure of results (including clinical trial registries, the International Federation of Pharmaceutical Manufacturers and Associations [IFPMA] Clinical Trials Portal, EMA European Public Assessment Reports and PubMed), searched from 27 December 2012 to 31 January 2013. The study covered all 53 new medicines (except vaccines and fixed-dose combinations) approved for marketing by 34 pharmaceutical companies by the EMA in 2009, 2010 and 2011. It included all completed company-sponsored clinical trials conducted in patients and recorded on a clinical trial registry and/or included in an EPAR. OUTCOME MEASURE AND RESULTS: The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 January 2013 (end of survey). Of the completed clinical trials associated with all 53 new medicines approved by the EMA between 2009 and 2011, 77% had results disclosed within 12 months. By 31 January 2013, this had increased to 89%. Rates of results disclosure within 12 months were 71%, 81% and 86% for new medicines approved in 2009, 2010 and 2011 respectively. Disclosure increased to 86%, 93% and 91% respectively by 31 January 2013. Although this was a purely quantitative study which did not aim to assess the content of disclosure against any specific requirements, limitations relating to a number of

  5. [Treatment of vascular dementia by Chinese herbal medicine: a systematic review of randomized controlled trials of clinical studies].

    PubMed

    Jian, Wen-Jia; Shi, Jing; Tian, Jin-Zhou; Ni, Jing-Nian

    2015-01-01

    Chinese herbal medicine has been extensively used in the treatment of vascular dementia (VaD), but lacked systematic review on its efficacy and safety. So we conducted a systematic review to assess the efficacy and safety of Chinese herbal medicine in treating VaD. CNKI, CBM, PubMed, and Wiley Online Library were retrieved for randomized trials (RCTs) on Chinese herbal medicine treating VaD patients. Randomized parallel control trials by taking Chinese herbal medicine as one treatment method and placebos/cholinesterase inhibitors/Memantine hydrochloride as the control were included. Quality rating and data extraction were performed. RevMan5.2.0 Software was used for meta-analysis. Standardized mean difference (SMD) at 95% confidence interval (CI) was used to indicate effect indicators of results. Seven RCTs met the inclusive criteria. Totally 677 VaD patients were randomly assigned to the treatment group and the control group. Descriptive analyses were performed in inclusive trials. The cognitive function was assessed in all trials. Results showed Mini-Mental state examination (MMSE) score was better in the Chinese herbal medicine group than in the placebo group, but with no significant difference when compared with the donepezil group (P > 0.05). Adverse reactions were mainly manifested as gastrointestinal symptoms such as abdominal pain in the Chinese herbal medicine group. But they occurred more in the donepezil group than in the Chinese herbal medicine group. The methodological quality of included trials was poor with less samples. Results of different trials were lack of consistency. Present evidence is not sufficient to prove or disapprove the role of Chinese herbal medicine in improving clinical symptoms and outcome indicators of VaD patients. Their clinical efficacy and safety need to be supported by more higher quality RCTs.

  6. Chinese herbal medicine and clomiphene citrate for anovulation: a meta-analysis of randomized controlled trials.

    PubMed

    See, Caylie J; McCulloch, Michael; Smikle, Collin; Gao, Jin

    2011-05-01

    The study objective was to investigate the efficacy of Chinese herbal medicine for improving standard infertility treatments. A search of the literature between 2000 and 2006 was done in English and Chinese using the search terms anovulation, infertility, clomiphene citrate, Chinese herbal medicine, and randomized controlled trials. A review was done of 1009 studies with selection criteria including randomized controlled trials (RCTs) of Chinese herbal medicine combined with clomiphene citrate (CC) versus a control arm using CC alone with primary endpoints of changes in basal body temperatures, ovulation rates, endometrial lining, and pregnancy outcomes. Fourteen (14) randomized studies representing 1316 patients met inclusion criteria. Four (4) studies (n = 315) reported 14% higher likelihood of biphasic basal body temperatures (risk ratios [RR] = 1.14; 95% confidence interval [CI], 1.00, 1.29). Six (6) studies (n = 604) reported a nonsignificant 18% increase in ovulation rates (RR = 1.18; 95% CI, 0.91, 1.52). Two studies (n = 138) reported subjects 78% more likely to have endometrial lining greater than 6 mm (RR = 1.78; 95% CI, 1.22, 2.60). Thirteen (13) studies (n = 1202) reported a 50% increase in pregnancy rates (RR = 1.50; 95% CI, 1.23, 1.84). Chinese herbal medicine may increase the effectiveness of CC therapy. However, the RCTs are of poor methodological quality and small sample size, and the results require confirmation with rigorously controlled studies.

  7. The MedSeq Project: a randomized trial of integrating whole genome sequencing into clinical medicine.

    PubMed

    Vassy, Jason L; Lautenbach, Denise M; McLaughlin, Heather M; Kong, Sek Won; Christensen, Kurt D; Krier, Joel; Kohane, Isaac S; Feuerman, Lindsay Z; Blumenthal-Barby, Jennifer; Roberts, J Scott; Lehmann, Lisa Soleymani; Ho, Carolyn Y; Ubel, Peter A; MacRae, Calum A; Seidman, Christine E; Murray, Michael F; McGuire, Amy L; Rehm, Heidi L; Green, Robert C

    2014-03-20

    Whole genome sequencing (WGS) is already being used in certain clinical and research settings, but its impact on patient well-being, health-care utilization, and clinical decision-making remains largely unstudied. It is also unknown how best to communicate sequencing results to physicians and patients to improve health. We describe the design of the MedSeq Project: the first randomized trials of WGS in clinical care. This pair of randomized controlled trials compares WGS to standard of care in two clinical contexts: (a) disease-specific genomic medicine in a cardiomyopathy clinic and (b) general genomic medicine in primary care. We are recruiting 8 to 12 cardiologists, 8 to 12 primary care physicians, and approximately 200 of their patients. Patient participants in both the cardiology and primary care trials are randomly assigned to receive a family history assessment with or without WGS. Our laboratory delivers a genome report to physician participants that balances the needs to enhance understandability of genomic information and to convey its complexity. We provide an educational curriculum for physician participants and offer them a hotline to genetics professionals for guidance in interpreting and managing their patients' genome reports. Using varied data sources, including surveys, semi-structured interviews, and review of clinical data, we measure the attitudes, behaviors and outcomes of physician and patient participants at multiple time points before and after the disclosure of these results. The impact of emerging sequencing technologies on patient care is unclear. We have designed a process of interpreting WGS results and delivering them to physicians in a way that anticipates how we envision genomic medicine will evolve in the near future. That is, our WGS report provides clinically relevant information while communicating the complexity and uncertainty of WGS results to physicians and, through physicians, to their patients. This project will not only

  8. Precision Medicine for Molecularly Targeted Agents and Immunotherapies in Early-Phase Clinical Trials

    PubMed Central

    Lopez, Juanita; Harris, Sam; Roda, Desam; Yap, Timothy A

    2015-01-01

    Precision medicine in oncology promises the matching of genomic, molecular, and clinical data with underlying mechanisms of a range of novel anticancer therapeutics to develop more rational and effective antitumor strategies in a timely manner. However, despite the remarkable progress made in the understanding of novel drivers of different oncogenic processes, success rates for the approval of oncology drugs remain low with substantial fiscal consequences. In this article, we focus on how recent rapid innovations in technology have brought greater clarity to the biological and clinical complexities of different cancers and advanced the development of molecularly targeted agents and immunotherapies in clinical trials. We discuss the key challenges of identifying and validating predictive biomarkers of response and resistance using both tumor and surrogate tissues, as well as the hurdles associated with intratumor heterogeneity. Finally, we outline evolving strategies employed in early-phase trial designs that incorporate omics-based technologies. PMID:26609214

  9. [Exploration into the preparation of placebos used in Chinese medicinal clinical trial].

    PubMed

    Tang, Xu-Dong; Bian, Li-Qun; Gao, Rui

    2009-07-01

    Placebo-controlled clinical trials have been more and more emphasized in traditional Chinese medicine (TCM) researches, while the preparation of TCM placebos is still to be improved. For this work, some elements should be taken into consideration comprehensively, including the design of clinical trial, the characteristics of researched disease, the nature of testing drugs, and the way of medication, etc. And the technological process for placebo manufacturing should be selected properly depending upon the basis of the above elements. Un-biased foodstuff is good as excipient for TCM placebos preparation. The placebo should be made in dosage-form similar to that of the testing drug as possible, if there are difficulties for simulating them in appearance and smell completely. However, its potential pharmacological activity meeting to the acceptance of researchers should be ensured.

  10. Launching a salt substitute to reduce blood pressure at the population level: a cluster randomized stepped wedge trial in Peru

    PubMed Central

    2014-01-01

    Background Controlling hypertension rates and maintaining normal blood pressure, particularly in resource-constrained settings, represent ongoing challenges of effective and affordable implementation in health care. One of the strategies being largely advocated to improve high blood pressure calls for salt reduction strategies. This study aims to estimate the impact of a population-level intervention based on sodium reduction and potassium increase – in practice, introducing a low-sodium, high-potassium salt substitute – on adult blood pressure levels. Methods/Design The proposed implementation research study includes two components: Phase 1, an exploratory component, and Phase 2, an intervention component. The exploratory component involves a triangle taste test and a formative research study designed to gain an understanding of the best implementation methods. Phase 2 involves a pragmatic stepped wedge trial design where the intervention will be progressively implemented in several clusters starting the intervention randomly at different times. In addition, we will evaluate the implementation strategy using a cost-effectiveness analysis. Discussion This is the first project in a Latin-American setting to implement a salt substitution intervention at the population level to tackle high blood pressure. Data generated and lessons learnt from this study will provide a strong platform to address potential interventions applicable to other similar low- and middle-income settings. Trial registration This study is registered in ClinicalTrials.gov NCT01960972. PMID:24667035

  11. Searching for Controlled Trials of Complementary and Alternative Medicine: A Comparison of 15 Databases

    PubMed Central

    Cogo, Elise; Sampson, Margaret; Ajiferuke, Isola; Manheimer, Eric; Campbell, Kaitryn; Daniel, Raymond; Moher, David

    2011-01-01

    This project aims to assess the utility of bibliographic databases beyond the three major ones (MEDLINE, EMBASE and Cochrane CENTRAL) for finding controlled trials of complementary and alternative medicine (CAM). Fifteen databases were searched to identify controlled clinical trials (CCTs) of CAM not also indexed in MEDLINE. Searches were conducted in May 2006 using the revised Cochrane highly sensitive search strategy (HSSS) and the PubMed CAM Subset. Yield of CAM trials per 100 records was determined, and databases were compared over a standardized period (2005). The Acudoc2 RCT, Acubriefs, Index to Chiropractic Literature (ICL) and Hom-Inform databases had the highest concentrations of non-MEDLINE records, with more than 100 non-MEDLINE records per 500. Other productive databases had ratios between 500 and 1500 records to 100 non-MEDLINE records—these were AMED, MANTIS, PsycINFO, CINAHL, Global Health and Alt HealthWatch. Five databases were found to be unproductive: AGRICOLA, CAIRSS, Datadiwan, Herb Research Foundation and IBIDS. Acudoc2 RCT yielded 100 CAM trials in the most recent 100 records screened. Acubriefs, AMED, Hom-Inform, MANTIS, PsycINFO and CINAHL had more than 25 CAM trials per 100 records screened. Global Health, ICL and Alt HealthWatch were below 25 in yield. There were 255 non-MEDLINE trials from eight databases in 2005, with only 10% indexed in more than one database. Yield varied greatly between databases; the most productive databases from both sampling methods were Acubriefs, Acudoc2 RCT, AMED and CINAHL. Low overlap between databases indicates comprehensive CAM literature searches will require multiple databases. PMID:19468052

  12. [Challenges in the organization of investigator initiated trials: in transplantation medicine].

    PubMed

    Schnitzbauer, A A; Lamby, P E; Mutzbauer, I; von Hassel, J; Geissler, E K; Schlitt, H J

    2011-03-01

    Transplantation medicine offers multiple translational questions which should preferably be transferred to clinical evidence. The current gold standard for testing such questions and hypotheses is by prospective randomized controlled trials (RCT). The trials should be performed independently from the medical industry to avoid conflicts of interests and to guarantee a strict scientific approach. A good model is an investigator initiated trial (IIT) in which academic institutions function as the sponsor and in which normally a scientific idea stands before marketing interests of a certain medical product. We present a model for an IIT which is sponsored and coordinated by Regensburg University Hospital at 45 sites in 13 nations (SiLVER study), highlight special pitfalls of this study and offer alternatives to this approach. Finances: financial support in clinical trials can be obtained from the medical industry. Alternatively in Germany the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) offers annual grants. The expansion of financial support through foundations is desirable. Infrastructure: sponsorship within the pharmaceutics act (Arzneimittelgesetz) demands excellent infrastructural conditions and a professional team to accomplish clinical, logistic, regulatory, legal and ethical challenges in a RCT. If a large trial has sufficient financial support certain tasks can be outsourced and delegated to contract research organizations, coordinating centers for clinical trials or partners in the medical industry. Clinical scientific advances to improve evidence are an enormous challenge when performed as an IIT. However, academic sponsors can perform (international) IITs when certain rules are followed and should be defined as the gold standard when scientific findings have to be established clinically.

  13. Conflict of Interest and the CREATE-X Trial in the New England Journal of Medicine.

    PubMed

    Ozaki, Akihiko

    2017-09-15

    There is an increasing emphasis on clear disclosure of conflict of interest in medical communities, following repeated scientific frauds in clinical trials. However, incomplete COI statements continue to be prevalent in the medical community, as appears to have occurred in the Capecitabine for Residual Cancer as Adjuvant Therapy (CREATE-X) trial, which was recently published in the New England Journal of Medicine. The authors of the article did not clearly report the roles of the Japan Breast Cancer Research Group, a sponsor and funder of the study, although a majority of the Japanese authors served in important positions in the organization. Furthermore, the conflict of interest related to Chugai Pharmaceutical Company, a Japanese distributor of capecitabine, was not correctly disclosed. More transparent statements of conflict of interest and clarification of sponsors and funders' roles, as well as rigorous review by academic journals are required to fairly interpret the findings of clinical trials, including and beyond the single case of the CREATE-X trial.

  14. Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2013.

    PubMed

    Deane, Bryan R; Sivarajah, Jacintha

    2017-03-01

    The objective of this study was to assess the timely disclosure of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) during 2013. This is an extension of two previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012. The original study found that over a three year period over three-quarters of all trials were disclosed within 12 months and almost 90% were disclosed by the end of the study. The extension study (2012 approvals) showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% by the end of the study. The methodology used was exactly as previously reported. Various publicly available information sources were searched for both clinical trial registration and disclosure of results. All completed company-sponsored trials related to each new medicine approved for marketing by the EMA in 2013, carried out in patients and recorded on a clinical trials registry and/or included in an EMA European Public Assessment Report (EPAR), were included. Information sources were searched between 1 May and 31 July 2015. The main outcome measure was the proportion of trials for which results had been disclosed on a registry or in the scientific literature either within 12 months of the later of either first regulatory approval or trial completion, or by 31 July 2015 (end of survey). Of the completed trials associated with 34 new medicines licensed to 24 different companies in 2013, results of 90% (484/539) had been disclosed within 12 months, and results of 93% (500/539) had been disclosed by 31 July 2015. The disclosure rate within 12 months of 90% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 93% indicates that the improvement in transparency amongst company-sponsored trials has been maintained in the trials associated

  15. Launch Vehicles

    NASA Image and Video Library

    2007-09-09

    Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. Launch Pad 39B of the Kennedy Space Flight Center (KSC), currently used for Space Shuttle launches, will be revised to host the Ares launch vehicles. The fixed and rotating service structures standing at the pad will be dismantled sometime after the Ares I-X test flight. A new launch tower for Ares I will be built onto a new mobile launch platform. The gantry for the shuttle doesn't reach much higher than the top of the four segments of the solid rocket booster. Pad access above the current shuttle launch pad structure will not be required for Ares I-X because the stages above the solid rocket booster are inert. For the test scheduled in 2012 or for the crewed flights, workers and astronauts will need access to the highest levels of the rocket and capsule. When the Ares I rocket rolls out to the launch pad on the back of the same crawler-transporters used now, its launch gantry will be with it. The mobile launchers will nestle under three lightning protection towers to be erected around the pad area. Ares time at the launch pad will be significantly less than the three weeks or more the shuttle requires. This “clean pad” approach minimizes equipment and servicing at the launch pad. It is the same plan NASA used with the Saturn V rockets and industry employs it with more modern launchers. The launch pad will also get a new emergency escape system for astronauts, one that looks very much like a roller coaster. Cars riding on a rail will replace the familiar baskets hanging from steel cables. This artist's concept illustrates the Ares I on launch pad 39B.

  16. Launch vehicle

    NASA Astrophysics Data System (ADS)

    Rutledge, William S.

    1994-06-01

    Concentrated efforts by NASA and the DOD to begin development of a new large launch vehicle have been under way for over a decade. Options include the National Launch System, Advanced Launch System, a heavy lift vehicle, a Shuttle-derived vehicle, a Titan-derived vehicle, Single stage To Orbit, NASP and Spacelifter, to name a few. All initially promised low operations costs achieved at development costs in the $5 billion - $10 billion range. However, none has obtained approval for development, primarily because it became apparent that these cost goals could not realistically be met.

  17. CONSORT and the internal validity of randomized controlled trials in Female Pelvic Medicine.

    PubMed

    Koch, Marianne; Riss, Paul; Umek, Wolfgang; Hanzal, Engelbert

    2016-09-01

    To investigate authors' adherence to the CONSORT reporting guideline for randomized controlled trials (RCTs) in the sub-specialty Female Pelvic Medicine and to detect any changes in adherence between the years 2008 and 2013. Bibliometric study. We included Female Pelvic Medicine RCTs published in 2008 and 2012-2013 in 10 journals. Full-text versions of RCTs for the inclusion of the CONSORT checklist items Randomization, Allocation, Blinding, and Participants' flowchart were screened. Each CONSORT checklist item was categorized for each included RCT as either "complete reporting", "insufficient reporting", "no reporting," or "not applicable". We screened the "Instructions to authors" for the requirement to adhere to CONSORT. We included 94 Female Pelvic Medicine RCTs for analysis. Most RCTs in 2008, 2012, and 2013 were published by IUJ (n =n39), followed by NAU (n = 13), GREEN (n = 12), European Urology (n = 8), FMPRS (n = 6), AJOG (n = 4), Urology (n = 3), NEJM (n = 3), Lancet (n = 1), and BJOG (n = 1). Proportion of RCTs in the category "complete reporting" comparing 2008 and 2013 was (47 and 70%) for Randomization, (18 and 45%) for Allocation, and (29 and 52%) for Blinding; a flowchart was presented in (71 and 91%). The increase was not statistically significant in any of the investigated CONSORT items. Complete reporting of Female Pelvic Medicine RCTs has increased between 2008 and 2013. However, there are still a relevant number of published RCTs, which do not fulfill these criteria. Reporting according to the CONSORT guidelines should be further encouraged to improve internal validity of Female Pelvic Medicine RCTs. Neurourol. Urodynam. 35:826-830, 2016. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc.

  18. NPP Launch

    NASA Image and Video Library

    NASA's National Polar-orbiting Operational Environmental Satellite System Preparatory Project (NPP) spacecraft was launched aboard a Delta II rocket at 5:48 a.m. EDT today, on a mission to measure ...

  19. Using ClinicalTrials.gov to understand the state of clinical research in pulmonary, critical care, and sleep medicine.

    PubMed

    Todd, Jamie L; White, Kyle R; Chiswell, Karen; Tasneem, Asba; Palmer, Scott M

    2013-10-01

    ClinicalTrials.gov is the largest trial registry in the world. Strengthened registration requirements, including federal mandates in 2007, have increased study representation. A systematic evaluation of all registered studies has been limited by the absence of an aggregate data set and specialty-specific search terms. We leveraged a newly transformed database containing annotated data from ClinicalTrials.gov to define the portfolio of interventional clinical research in pulmonary, critical care, and sleep medicine. Analysis was restricted to studies registered after September 2007 through September 2010 and defined as "interventional" (n = 40,970). A specialty-specific study data set (n = 2,226) was created using disease condition terms provided by data submitters and medical subject heading terms generated by a National Library of Medicine algorithm. Trial characteristics were extracted and summarized using descriptive statistics. Pulmonary, critical care, and sleep medicine trials composed 5.4% of all interventional studies registered over the 3-year period. In contrast, oncology and cardiovascular disease composed 21.9 and 8.4% of trials, respectively. Within pulmonary trials, asthma and chronic obstructive pulmonary disease were the most studied conditions (27.4 and 21.8% of studies, respectively), and measures of lung function or safety were the most frequent primary outcomes. Nearly two-thirds of trials indicated enrollment of 100 patients or fewer, and a majority of studies were phase II or III trials. The single largest funding source (43.5%) was industry, and study characteristics varied by funding source. We applied a novel approach to describe the portfolio of interventional clinical research in pulmonary medicine. Our results indicate a disparity between trial representation and the burden of respiratory disease. Resources should be targeted across the spectrum of pulmonary research to address this discrepancy.

  20. Orion Launch

    NASA Image and Video Library

    2014-12-05

    A Delta IV Heavy rocket lifts off from Space Launch Complex 37 at Cape Canaveral Air Force Station in Florida carrying NASA's Orion spacecraft on an unpiloted flight test to Earth orbit. Liftoff was at 7:05 a.m. EST. During the two-orbit, four-and-a-half hour mission, engineers will evaluate the systems critical to crew safety, the launch abort system, the heat shield and the parachute system.

  1. Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials.

    PubMed

    Cheng, Chung-Wah; Bian, Zhao-Xiang; Li, You-Ping; Moher, David; Wu, Tai-Xiang; Dagenais, Simon; Li, Jing; Li, Ting-Qian

    2008-09-01

    Although all Chinese materia medica (CMM) come from nature, CMM interventions have both therapeutic effects and adverse effects (AEs). Normally, AEs in randomized controlled trial (RCT) with traditional Chinese medicine (TCM) could be divided into five types as follows: 1) AEs under proper TCM principles and guidelines, such as the toxicity (acute and chronic) and allergy; 2) AEs due to improper usage without following TCM principles, involving without following the TCM therapeutic principles, over-dosage, improper processing and preparation methods, improper formula strategy, etc; 3) AEs due to contamination in CMM, such as heavy metal and pesticides contaminations in Chinese herbal medicine interventions, and intentional or unintentional contamination with drug(s); 4) AEs due to replacement of CMMs; 5) AEs due to drug-herb interaction. AEs of TCM should be treated properly. Overestimation or underestimation about AEs of TCM intervention will bring a wrong message to patients and health care providers. In order to give readers a more comprehensive understanding about the safety issue of study intervention, Consolidated Standards of Reporting Trials (CONSORT) for TCM should involve the background information on side effects of each CMM constituents and/or the study intervention, specific outcome assessment on AEs, the details of reported AEs and the interpretation of the AEs occurrence in a structural RCT report.

  2. Efficacy and safety of Chinese herbal medicine for benign prostatic hyperplasia: systematic review of randomized controlled trials.

    PubMed

    Ma, Chun Ho; Lin, Wai Ling; Lui, Sing Leung; Cai, Xun-Yuan; Wong, Vivian Taam; Ziea, Eric; Zhang, Zhang-Jin

    2013-07-01

    Chinese herbal medicine is commonly used as a treatment for benign prostatic hyperplasia (BPH), but its efficacy and safety remain to be examined. To compare the efficacy and adverse events of Chinese herbal medicine alone or used adjuvantly with Western medications for BPH. Two independent reviewers searched the major electronic databases for randomized controlled trials comparing Chinese herbal medicine, either in single or adjuvant use with Western medication, with placebo or Western medication. Relevant journals and grey literature were also hand-searched. The outcome measures included changes in urological symptoms, urodynamic measures, prostate volume and adverse events. The frequency of commonly used herbs was also identified. Out of 13 922 identified citations of publications, 31 studies were included. Eleven studies with a Jadad score ≥ 3 were selected for meta-analysis. Chinese herbal medicine was superior to Western medication in improving quality of life and reducing prostate volume. The frequency of adverse events in Chinese herbal medicine was similar to that of placebo and less than that of Western medication. The evidence is too weak to support the efficacy of Chinese herbal medicine for BPH due to the poor methodological quality and small number of trials included. The commonly used herbs identified here should provide insights for future clinical practice and research. Larger randomized controlled trials of better quality are needed to truly evaluate the efficacy of Chinese herbal medicine.

  3. Efficacy and safety of Chinese herbal medicine for benign prostatic hyperplasia: systematic review of randomized controlled trials

    PubMed Central

    Ma, Chun Ho; Lin, Wai Ling; Lui, Sing Leung; Cai, Xun-Yuan; Wong, Vivian Taam; Ziea, Eric; Zhang, Zhang-Jin

    2013-01-01

    Chinese herbal medicine is commonly used as a treatment for benign prostatic hyperplasia (BPH), but its efficacy and safety remain to be examined. To compare the efficacy and adverse events of Chinese herbal medicine alone or used adjuvantly with Western medications for BPH. Two independent reviewers searched the major electronic databases for randomized controlled trials comparing Chinese herbal medicine, either in single or adjuvant use with Western medication, with placebo or Western medication. Relevant journals and grey literature were also hand-searched. The outcome measures included changes in urological symptoms, urodynamic measures, prostate volume and adverse events. The frequency of commonly used herbs was also identified. Out of 13 922 identified citations of publications, 31 studies were included. Eleven studies with a Jadad score ≥3 were selected for meta-analysis. Chinese herbal medicine was superior to Western medication in improving quality of life and reducing prostate volume. The frequency of adverse events in Chinese herbal medicine was similar to that of placebo and less than that of Western medication. The evidence is too weak to support the efficacy of Chinese herbal medicine for BPH due to the poor methodological quality and small number of trials included. The commonly used herbs identified here should provide insights for future clinical practice and research. Larger randomized controlled trials of better quality are needed to truly evaluate the efficacy of Chinese herbal medicine. PMID:23728585

  4. A proposal to use iterative, small clinical trials to optimize therapeutic HIV vaccine immunogens to launch therapeutic HIV vaccine development.

    PubMed

    Shapiro, Stuart Z

    2015-01-01

    The HIV cure agenda has rekindled interest in the development of a therapeutic HIV vaccine. An iterative clinical trial strategy that proved successful for the development of effective cancer chemotherapies in the 1960s may be applicable to the development of a CD8 T lymphocyte-based therapeutic HIV vaccine. However, while cancer chemotherapy development could begin with iterative clinical trials to improve the use of active drugs, the first step in therapeutic HIV vaccine design should be discovery of immunogen constructs with potential for activity and their optimization to meet the challenges of HIV-1 sequence diversity and human polymorphism in T cell antigen presentation. A strategy for doing this is discussed in this article. The proposed strategy relies on a major commitment by funding organizations to fund organized and coordinated manufacture and clinical testing of a series of first- and second-generation constructs to test basic concepts in product design. This is presented as an alternative to funding a more traditional competition among private manufacturers and product champions of individual, already designed products.

  5. Launching a salt substitute to reduce blood pressure at the population level: a cluster randomized stepped wedge trial in Peru.

    PubMed

    Bernabe-Ortiz, Antonio; Diez-Canseco, Francisco; Gilman, Robert H; Cárdenas, María K; Sacksteder, Katherine A; Miranda, J Jaime

    2014-03-25

    Controlling hypertension rates and maintaining normal blood pressure, particularly in resource-constrained settings, represent ongoing challenges of effective and affordable implementation in health care. One of the strategies being largely advocated to improve high blood pressure calls for salt reduction strategies. This study aims to estimate the impact of a population-level intervention based on sodium reduction and potassium increase - in practice, introducing a low-sodium, high-potassium salt substitute - on adult blood pressure levels. The proposed implementation research study includes two components: Phase 1, an exploratory component, and Phase 2, an intervention component. The exploratory component involves a triangle taste test and a formative research study designed to gain an understanding of the best implementation methods. Phase 2 involves a pragmatic stepped wedge trial design where the intervention will be progressively implemented in several clusters starting the intervention randomly at different times. In addition, we will evaluate the implementation strategy using a cost-effectiveness analysis. This is the first project in a Latin-American setting to implement a salt substitution intervention at the population level to tackle high blood pressure. Data generated and lessons learnt from this study will provide a strong platform to address potential interventions applicable to other similar low- and middle-income settings. This study is registered in ClinicalTrials.gov NCT01960972.

  6. Ethical standards for clinical trials conducted in third countries: the new strategy of the European Medicines Agency.

    PubMed

    Altavilla, Annagrazia

    2011-01-01

    Clinical trials increasingly occur on a global scale as industry and government sponsors in wealthy countries move trials to low- and middle-income countries. The globalization of clinical research raises important questions about the economical and ethical aspects of clinical research and the translation of trial results to clinical practice: which ethical standards are applied? Are trials results accurate and valid, and can they be extrapolated to other settings? This article provides an overview of the strategy approved by the European Medicines Agency (EMA) to clarify ethical standards for clinical research conducted outside the European Economic Area (EEA) and included in Marketing Authorization Applications. Reference to the EMA Reflection paper is made.

  7. Comprehensive rehabilitation with integrative medicine for subacute stroke: A multicenter randomized controlled trial.

    PubMed

    Fang, Jianqiao; Chen, Lifang; Ma, Ruijie; Keeler, Crystal Lynn; Shen, Laihua; Bao, Yehua; Xu, Shouyu

    2016-05-13

    To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton's Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation.

  8. Comprehensive rehabilitation with integrative medicine for subacute stroke: A multicenter randomized controlled trial

    PubMed Central

    Fang, Jianqiao; Chen, Lifang; Ma, Ruijie; Keeler, Crystal Lynn; Shen, Laihua; Bao, Yehua; Xu, Shouyu

    2016-01-01

    To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton’s Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P < 0.01 or P < 0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P < 0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation. PMID:27174221

  9. Complementary and alternative medicine (CAM) in reproductive-age women: a review of randomized controlled trials.

    PubMed

    Fugh-Berman, Adriane; Kronenberg, Fredi

    2003-01-01

    Complementary and alternative medicine (CAM) therapies are widely used in the general population. This paper reviews randomized controlled trials of CAM therapies for obstetrical and gynecologic conditions and presents therapies that are likely to be used by women of reproductive age and by pregnant women. Sources included English-language papers in MEDLINE 1966-2002 and AMED (1985-2000) and the authors' extensive holdings. Randomized controlled clinical trials of CAM therapies for obstetric and gynecologic conditions. Clinical information was extracted from the articles and summarized in tabular form or in the text. Ninety-three trials were identified, 45 of which were for pregnancy-related conditions, 33 of which were for premenstrual syndrome, and 13 of which were for dysmenorrhea. Data support the use of acupressure for nausea of pregnancy and calcium for PMS. Preliminary studies indicate a role for further research on Vitamin B6 or ginger for nausea and vomiting of pregnancy; calcium, magnesium, Vitamin B6, or chaste-tree berry extract for PMS; and a low-fat diet, exercise, or fish oil supplementation for dysmenorrhea. Limited evidence supports the efficacy of some CAM therapies. Exposure of women of reproductive age to these therapies can be expected.

  10. Systematic review of randomised controlled trials of over the counter cough medicines for acute cough in adults

    PubMed Central

    Schroeder, Knut; Fahey, Tom

    2002-01-01

    Objectives To determine whether over the counter cough medicines are effective for acute cough in adults. Design Systematic review of randomised controlled trials. Data sources Search of the Cochrane Acute Respiratory Infections Group specialised register, Cochrane Controlled Trials Register, Medline, Embase, and the UK Department of Health National Research Register in all languages. Included studies All randomised controlled trials that compared oral over the counter cough preparations with placebo in adults with acute cough due to upper respiratory tract infection in ambulatory settings and that had cough symptoms as an outcome. Results 15 trials involving 2166 participants met all the inclusion criteria. Antihistamines seemed to be no better than placebo. There was conflicting evidence on the effectiveness of antitussives, expectorants, antihistamine-decongestant combinations, and other drug combinations compared with placebo. Conclusion Over the counter cough medicines for acute cough cannot be recommended because there is no good evidence for their effectiveness. Even when trials had significant results, the effect sizes were small and of doubtful clinical relevance. Because of the small number of trials in each category, the results have to be interpreted cautiously. What is already know on this topicThe NHS encourages self treatment of acute self limiting illnessesOver the counter cough medicines are commonly used as first line treatment for acute coughWhat this study addsThere is little evidence for or against the effectiveness of over the counter cough medicinesAlthough cough medicines are generally well tolerated, they may be an unnecessary expenseRecommendation of over the counter cough medicines to patients is not justified by current evidence PMID:11834560

  11. Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial.

    PubMed

    Gu, Sherman X; Zhang, Anthony L; Coyle, Meaghan E; Mo, Xiumei; Lenon, George B; Cranswick, Noel E; Chen, DaCan; Xue, Charlie C

    2015-07-07

    Atopic eczema or atopic dermatitis is a chronic inflammatory skin disease. Current conventional medical treatment for moderate and severe atopic eczema is not satisfactory. There is promising evidence derived from randomised clinical trials to support the clinical use of Chinese herbal medicine in the management of atopic eczema. However, the available evidence is compromised by the high risk of bias associated with most of the included trials. Therefore, well-designed and adequately powered randomised clinical trials are needed. The primary aim of this trial is to evaluate the efficacy and safety of oral ingestion of an oral Chinese herbal formula (Pei Tu Qing Xin granules; PTQX) in children aged between 6 and 16 years with moderate to severe atopic eczema. We have designed a randomised, double-blind, placebo-controlled, two-arm, parallel clinical trial with 12 weeks of treatment and a 4-week follow-up period. A pilot study with 30 participants will be conducted at the RMIT University in Australia to determine the feasibility of the full-scale randomised clinical trial (N = 124). Eczema Area and Severity Index score will be the primary outcome. Secondary outcome measures include change in symptoms using the Patient-Oriented Eczema Measure, the Children's Dermatology Life Quality Index and the use of concomitant medicines. Safety parameters include report of adverse events and pathology tests during the trial period. Key elements for conducting a high-quality randomised clinical trial have been addressed in this protocol. Findings from the proposed trial will provide critical evidence regarding Chinese herbal medicine treatment for atopic eczema. Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614001172695. Date of Registration: 7 November 2014.

  12. Launch Vehicles

    NASA Image and Video Library

    1961-01-01

    This is a comparison illustration of the Redstone, Jupiter-C, and Mercury Redstone launch vehicles. The Redstone ballistic missile was a high-accuracy, liquid-propelled, surface-to-surface missile. Originally developed as a nose cone re-entry test vehicle for the Jupiter intermediate range ballistic missile, the Jupiter-C was a modification of the Redstone missile and successfully launched the first American Satellite, Explorer-1, in orbit on January 31, 1958. The Mercury Redstone lifted off carrying the first American, astronaut Alan Shepard, in his Mercury spacecraft Freedom 7, on May 5, 1961.

  13. Precision Medicine for Advanced Pancreas Cancer: The Individualized Molecular Pancreatic Cancer Therapy (IMPaCT) Trial.

    PubMed

    Chantrill, Lorraine A; Nagrial, Adnan M; Watson, Clare; Johns, Amber L; Martyn-Smith, Mona; Simpson, Skye; Mead, Scott; Jones, Marc D; Samra, Jaswinder S; Gill, Anthony J; Watson, Nicole; Chin, Venessa T; Humphris, Jeremy L; Chou, Angela; Brown, Belinda; Morey, Adrienne; Pajic, Marina; Grimmond, Sean M; Chang, David K; Thomas, David; Sebastian, Lucille; Sjoquist, Katrin; Yip, Sonia; Pavlakis, Nick; Asghari, Ray; Harvey, Sandra; Grimison, Peter; Simes, John; Biankin, Andrew V

    2015-05-01

    Personalized medicine strategies using genomic profiling are particularly pertinent for pancreas cancer. The Individualized Molecular Pancreatic Cancer Therapy (IMPaCT) trial was initially designed to exploit results from genome sequencing of pancreatic cancer under the auspices of the International Cancer Genome Consortium (ICGC) in Australia. Sequencing revealed small subsets of patients with aberrations in their tumor genome that could be targeted with currently available therapies. The pilot stage of the IMPaCT trial assessed the feasibility of acquiring suitable tumor specimens for molecular analysis and returning high-quality actionable genomic data within a clinically acceptable timeframe. We screened for three molecular targets: HER2 amplification; KRAS wild-type; and mutations in DNA damage repair pathways (BRCA1, BRCA2, PALB2, ATM). Tumor biopsy and archived tumor samples were collected from 93 patients and 76 were screened. To date 22 candidate cases have been identified: 14 KRAS wild-type, 5 cases of HER2 amplification, 2 mutations in BRCA2, and 1 ATM mutation. Median time from consent to the return of validated results was 21.5 days. An inability to obtain a biopsy or insufficient tumor content in the available specimen were common reasons for patient exclusion from molecular analysis while deteriorating performance status prohibited a number of patients from proceeding in the study. Documenting the feasibility of acquiring and screening biospecimens for actionable molecular targets in real time will aid other groups embarking on similar trials. Key elements include the need to better prescreen patients, screen more patients, and offer more attractive clinical trial options. ©2015 American Association for Cancer Research.

  14. Bioinformatics for precision medicine in oncology: principles and application to the SHIVA clinical trial

    PubMed Central

    Servant, Nicolas; Roméjon, Julien; Gestraud, Pierre; La Rosa, Philippe; Lucotte, Georges; Lair, Séverine; Bernard, Virginie; Zeitouni, Bruno; Coffin, Fanny; Jules-Clément, Gérôme; Yvon, Florent; Lermine, Alban; Poullet, Patrick; Liva, Stéphane; Pook, Stuart; Popova, Tatiana; Barette, Camille; Prud’homme, François; Dick, Jean-Gabriel; Kamal, Maud; Le Tourneau, Christophe; Barillot, Emmanuel; Hupé, Philippe

    2014-01-01

    Precision medicine (PM) requires the delivery of individually adapted medical care based on the genetic characteristics of each patient and his/her tumor. The last decade witnessed the development of high-throughput technologies such as microarrays and next-generation sequencing which paved the way to PM in the field of oncology. While the cost of these technologies decreases, we are facing an exponential increase in the amount of data produced. Our ability to use this information in daily practice relies strongly on the availability of an efficient bioinformatics system that assists in the translation of knowledge from the bench towards molecular targeting and diagnosis. Clinical trials and routine diagnoses constitute different approaches, both requiring a strong bioinformatics environment capable of (i) warranting the integration and the traceability of data, (ii) ensuring the correct processing and analyses of genomic data, and (iii) applying well-defined and reproducible procedures for workflow management and decision-making. To address the issues, a seamless information system was developed at Institut Curie which facilitates the data integration and tracks in real-time the processing of individual samples. Moreover, computational pipelines were developed to identify reliably genomic alterations and mutations from the molecular profiles of each patient. After a rigorous quality control, a meaningful report is delivered to the clinicians and biologists for the therapeutic decision. The complete bioinformatics environment and the key points of its implementation are presented in the context of the SHIVA clinical trial, a multicentric randomized phase II trial comparing targeted therapy based on tumor molecular profiling versus conventional therapy in patients with refractory cancer. The numerous challenges faced in practice during the setting up and the conduct of this trial are discussed as an illustration of PM application. PMID:24910641

  15. Factors Influencing Participation in Clinical Trials: Emergency Medicine vs. Other Specialties.

    PubMed

    Kurt, Anita; Kincaid, Hope M; Curtis, Charity; Semler, Lauren; Meyers, Matthew; Johnson, Melanie; Careyva, Beth A; Stello, Brian; Friel, Timothy J; Knouse, Mark C; Smulian, John C; Jacoby, Jeanne L

    2017-08-01

    This study investigated factors that influence emergency medicine (EM) patients' decisions to participate in clinical trials and whether the impact of these factors differs from those of other medical specialties. A survey was distributed in EM, family medicine (FM), infectious disease (ID), and obstetrics/gynecology (OB/GYN) outpatient waiting areas. Eligibility criteria included those who were 18 years of age or older, active patients on the day of the survey, and able to complete the survey without assistance. We used the Kruskal-Wallis test and ordinal logistic regression analyses to identify differences in participants' responses. A total of 2,893 eligible subjects were approached, and we included 1,841 surveys in the final analysis. Statistically significant differences (p≤0.009) were found for eight of the ten motivating factors between EM and one or more of the other specialties. Regardless of a patient's gender, race, and education, the relationship with their doctor was more motivating to patients seen in other specialties than to EM patients (FM [odds ratio {OR}:1.752, 95% confidence interval {CI}{1.285-2.389}], ID [OR:3.281, 95% CI{2.293-4.695}], and OB/GYN [OR:2.408, 95% CI{1.741-3.330}]). EM's rankings of "how well the research was explained" and whether "the knowledge learned would benefit others" as their top two motivating factors were similar across other specialties. All nine barriers showed statistically significant differences (p≤0.008) between EM and one or more other specialties. Participants from all specialties indicated "risk of unknown side effects" as their strongest barrier. Regardless of the patients' race, "time commitment" was considered to be more of a barrier to other specialties when compared to EM (FM [OR:1.613, 95% CI{1.218-2.136}], ID [OR:1.340, 95% CI{1.006-1.784}], or OB/GYN [OR:1.901, 95% CI{1.431-2.526}]). Among the six resources assessed that help patients decide whether to participate in a clinical trial, only one

  16. Liquid dynamic medicine and N-of-1 clinical trials: a change of perspective in oncology research.

    PubMed

    Silvestris, Nicola; Ciliberto, Gennaro; De Paoli, Paolo; Apolone, Giovanni; Lavitrano, Maria Luisa; Pierotti, Marco A; Stanta, Giorgio

    2017-09-13

    The increasing use of genomics to define the pattern of actionable mutations and to test and validate new therapies for individual cancer patients, and the growing application of liquid biopsy to dynamically track tumor evolution and to adapt molecularly targeted therapy according to the emergence of tumor clonal variants is shaping modern medical oncology., In order to better describe this new therapeutic paradigm we propose the term "Liquid dynamic medicine" in the place of "Personalized or Precision medicine". Clinical validation of the "Liquid dynamic medicine" approach is best captured by N-of-1 trials where each patient acts as tester and control of truly personalized therapies.

  17. Systematic Reviews Published in Emergency Medicine Journals Do Not Routinely Search Clinical Trials Registries: A Cross-Sectional Analysis.

    PubMed

    Keil, Lukas G; Platts-Mills, Timothy F; Jones, Christopher W

    2015-10-01

    Publication bias compromises the validity of systematic reviews. This problem can be addressed in part through searching clinical trials registries to identify unpublished studies. This study aims to determine how often systematic reviews published in emergency medicine journals include clinical trials registry searches. We identified all systematic reviews published in the 6 highest-impact emergency medicine journals between January 1 and December 31, 2013. Systematic reviews that assessed the effects of an intervention were further examined to determine whether the authors described searching a clinical trials registry and whether this search identified relevant unpublished studies. Of 191 articles identified through PubMed search, 80 were confirmed to be systematic reviews. Our sample consisted of 41 systematic reviews that assessed a specific intervention. Eight of these 41 (20%) searched a clinical trials registry. For 4 of these 8 reviews, the registry search identified at least 1 relevant unpublished study. Systematic reviews published in emergency medicine journals do not routinely include searches of clinical trials registries. By helping authors identify unpublished trial data, the addition of registry searches may improve the validity of systematic reviews. Copyright © 2014 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  18. Can homeopaths detect homeopathic medicines by dowsing? A randomized, double-blind, placebo-controlled trial

    PubMed Central

    McCarney, R; Fisher, P; Spink, F; Flint, G; van Haselen, R

    2002-01-01

    Dowsing is a method of problem-solving that uses a motor automatism, amplified through a pendulum or similar device. In a homeopathic context, it is used as an aid to prescribing and as a tool to identify miasm or toxin load. A randomized double-blind trial was conducted to determine whether six dowsing homeopaths were able to distinguish between Bryonia in a 12c potency and placebo by use of dowsing alone. The homeopathic medicine Bryonia was correctly identified in 48.1% of bottle pairs (n=156; 95% confidence interval 40.2%, 56.0%; P=0.689). These results, wholly negative, add to doubts whether dowsing in this context can yield objective information. PMID:11934908

  19. Launching "Dunno"

    ERIC Educational Resources Information Center

    Inson, Peter

    2005-01-01

    This article, written in response to an invitation from "CLE," describes the origins and controversial content of "dunno," a first novel, self-published by Peter Inson, a former teacher and headmaster. Inson considers influences upon his writing, the thinking which led him towards self-publication and the process of personally launching and…

  20. Do emergency medicine journals promote trial registration and adherence to reporting guidelines? A survey of "Instructions for Authors".

    PubMed

    Sims, Matthew T; Henning, Nolan M; Wayant, C Cole; Vassar, Matt

    2016-11-24

    The aim of this study was to evaluate the current state of two publication practices, reporting guidelines requirements and clinical trial registration requirements, by analyzing the "Instructions for Authors" of emergency medicine journals. We performed a web-based data abstraction from the "Instructions for Authors" of the 27 Emergency Medicine journals catalogued in the Expanded Science Citation Index of the 2014 Journal Citation Reports and Google Scholar Metrics h5-index to identify whether each journal required, recommended, or made no mention of the following reporting guidelines: EQUATOR Network, ICMJE, ARRIVE, CARE, CONSORT, STARD, TRIPOD, CHEERS, MOOSE, STROBE, COREQ, SRQR, SQUIRE, PRISMA-P, SPIRIT, PRISMA, and QUOROM. We also extracted whether journals required or recommended trial registration. Authors were blinded to one another's ratings until completion of the data validation. Cross-tabulations and descriptive statistics were calculated using IBM SPSS 22. Of the 27 emergency medicine journals, 11 (11/27, 40.7%) did not mention a single guideline within their "Instructions for Authors," while the remaining 16 (16/27, 59.3%) mentioned one or more guidelines. The QUOROM statement and SRQR were not mentioned by any journals whereas the ICMJE guidelines (18/27, 66.7%) and CONSORT statement (15/27, 55.6%) were mentioned most often. Of the 27 emergency medicine journals, 15 (15/27, 55.6%) did not mention trial or review registration, while the remaining 12 (12/27, 44.4%) at least mentioned one of the two. Trial registration through ClinicalTrials.gov was mentioned by seven (7/27, 25.9%) journals while the WHO registry was mentioned by four (4/27, 14.8%). Twelve (12/27, 44.4%) journals mentioned trial registration through any registry platform. The aim of this study was to evaluate the current state of two publication practices, reporting guidelines requirements and clinical trial registration requirements, by analyzing the "Instructions for Authors" of

  1. New Strategies in Personalized Medicine for Solid Tumors: Molecular Markers and Clinical Trial Designs

    PubMed Central

    Jürgensmeier, Juliane M.; Eder, Joseph P.; Herbst, Roy S.

    2017-01-01

    The delineation of signaling pathways to understand tumor biology combined with the rapid development of technologies that allow broad molecular profiling and data analysis, has led to a new era of personalized medicine in oncology. Many academic institutions now routinely profile patients and discuss them in personalized medicine tumor boards before making treatment recommendations. Clinical trials initiated by pharmaceutical companies often require specific markers for enrollment or at least explore multiple options for future markers. In addition to the still small number of targeted agents that are approved for the therapy of patients with histological and molecularly defined tumors, there is a broad range of novel targeted agents in development that are undergoing clinical studies with companion profiling to determine the best responding patient population. While the present focus of profiling are genetic analyses, additional testing of RNA, protein and immune parameters are being developed and incorporated in clinical research and are likely to contribute significantly to future patient selection and treatment approaches. As the advances in tumor biology and human genetics have identified promising tumor targets, the ongoing clinical evaluation of novel agents will now need to show if the promise can be translated into benefit for patients. PMID:25183480

  2. Exploratory trials, confirmatory observations: a new reasoning model in the era of patient-centered medicine.

    PubMed

    Sacristán, José A

    2011-04-25

    The prevailing view in therapeutic clinical research today is that observational studies are useful for generating new hypotheses and that controlled experiments (i.e., randomized clinical trials, RCTs) are the most appropriate method for assessing and confirming the efficacy of interventions. The current trend towards patient-centered medicine calls for alternative ways of reasoning, and in particular for a shift towards hypothetico-deductive logic, in which theory is adjusted in light of individual facts. A new model of this kind should change our approach to drug research and development, and regulation. The assessment of new therapeutic agents would be viewed as a continuous process, and regulatory approval would no longer be regarded as the final step in the testing of a hypothesis, but rather, as the hypothesis-generating step. The main role of RCTs in this patient-centered research paradigm would be to generate hypotheses, while observations would serve primarily to test their validity for different types of patients. Under hypothetico-deductive logic, RCTs are considered "exploratory" and observations, "confirmatory". In this era of tailored therapeutics, the answers to therapeutic questions cannot come exclusively from methods that rely on data aggregation, the analysis of similarities, controlled experiments, and a search for the best outcome for the average patient; they must also come from methods based on data disaggregation, analysis of subgroups and individuals, an integration of research and clinical practice, systematic observations, and a search for the best outcome for the individual patient. We must look not only to evidence-based medicine, but also to medicine-based evidence, in seeking the knowledge that we need.

  3. Randomized controlled trials in pediatric complementary and alternative medicine: Where can they be found?

    PubMed Central

    Sampson, Margaret; Campbell, Kaitryn; Ajiferuke, Isola; Moher, David

    2003-01-01

    Background The safety and effectiveness of CAM interventions are of great relevance to pediatric health care providers. The objective of this study is to identify sources of reported randomized controlled trials (RCTs) in the field of pediatric complementary and alternative medicine (CAM). Methods Reports of RCTs were identified by searching Medline and 12 additional bibliographic databases and by reviewing the reference lists of previously identified pediatric CAM systematic reviews. Results We identified 908 reports of RCTs that included children under 18 and investigated a CAM therapy. Since 1965, there has been a steady growth in the number of these trials that are being published. The four journals that published the most reported RCTs are The American Journal of Clinical Nutrition, Pediatrics, Journal of Pediatrics, and Lancet. Medline, CAB Health, and Embase were the best database sources for identifying these studies; they indexed 93.2%, 58.4% and 42.2 % respectively of the journals publishing reports of pediatric CAM RCTs. Conclusions Those working or interested in the field of pediatric CAM should routinely search Medline, CAB Health and Embase for literature in the field. The four core journals identified above should be included in their collection. PMID:12589711

  4. Comparison of effectiveness and safety between granules and decoction of Chinese herbal medicine: a systematic review of randomized clinical trials.

    PubMed

    Luo, Hui; Li, Qing; Flower, Andrew; Lewith, George; Liu, Jianping

    2012-04-10

    The clinical use of Chinese herbal medicine granules is gradually increasing. However, there is still no systematic review comparing the effectiveness and safety of granules with the more traditional method of herbal decoctions. A literature search was conducted using China National Knowledge Infrastructure Databases (CNKI), Chinese Science and Technology Periodical Database (VIP), China Biomedical Database web (CBM), Wanfang Database, PubMed, and the Cochrane Library until March 10, 2011. Clinical controlled trials (CCTs) including randomized trials (RCTs) comparing the effectiveness and safety between Chinese herbal medicine granules and decoction were included. Two authors conducted the literature searches, and extracted data independently. The assessment of methodological quality of RCTs was based on the risk of bias from the Cochrane Handbook, and the main outcome data of trials were analyzed by using RevMan 5.0 software. Risk ratio (RR) or mean difference (MD) with a 95% confidence interval (CI) were used as effect measure. 56 clinical trials (n=9748) including 42 RCTs and 14 CCTs were included, and all trials were conducted in China and published in Chinese literature. 40 types of diseases and 15 syndromes of traditional Chinese medicine (TCM) were reported. Granules were provided by pharmaceutical companies in 13 trials. The included RCTs were of generally low methodological quality: 7 trials reported adequate randomization methods, and 2 of these reported allocation concealment. 10 trials used blinding, of which 5 trials used placebo which were delivered double blind (blinded participants and practitioners). 98.2% (55/56) of studies showed that there was no significant statistical difference between granules and decoctions of Chinese herbal medicine for their effectiveness. No severe adverse effects in either group were reported. Due to the poor methodological quality of most of the included trials, it is not possible to reach a definitive conclusion

  5. Availability and affordability of new medicines in Latin American countries where pivotal clinical trials were conducted

    PubMed Central

    Ugalde, Antonio

    2015-01-01

    Abstract Objective To assess whether new pharmaceutical products approved by the United States Food and Drug Administration (FDA) in 2011 and 2012 were registered, commercialized and sold at affordable prices in the Latin American countries where they were tested. Methods We obtained a list of new molecular entities (new pharmaceutical products) approved by the FDA in 2011 and 2012. FDA medical reviews indicated the countries where pivotal clinical trials had been conducted. The registration status of the products was obtained from pharmaceutical registers; pharmaceutical companies confirmed their availability in national markets and local pricing observatories provided the price of medicines in retail pharmacies. Affordability was assessed as the cost of a course of treatment as a proportion of monthly income. Information on safety and efficacy was gathered from independent drug bulletins. Findings Of an expected 114 registrations, if the 33 products had been registered in all the countries where tested, only 68 (60%) were completed. Eight products were registered and commercialized in all countries but 10 had not been registered in any of the countries. With one exception, products for which we obtained pricing information (n = 18) cost more than the monthly minimum wage in all countries and 12 products cost at least five times the monthly minimum wage. Conclusion Many pharmaceutical products tested in Latin America are unavailable and/or unaffordable to most of the population. Ethical review committees should consider the local affordability and therapeutic relevance of new products as additional criteria for the approval of clinical trials. Finally, clinical trials have opportunity costs that need to be assessed. PMID:26600609

  6. Use of complementary medicine by adult patients participating in cancer clinical trials.

    PubMed

    Sparber, A; Bauer, L; Curt, G; Eisenberg, D; Levin, T; Parks, S; Steinberg, S M; Wootton, J

    2000-05-01

    To document the prevalence, demographic correlates, patterns of use, and beliefs about complementary and alternative medicine (CAM) therapies of adult patients enrolled in National Cancer Institute (NCI) clinical trials. Prospective, cross-sectional, descriptive survey. W.G. Magnuson Clinical Center of the National Institutes of Health in Bethesda, MD. Convenience sample of 100 English-speaking, adult patients with cancer admitted to intramural clinical trials. A standardized, 99-item questionnaire assessing use of CAM therapies pre- and postcancer diagnosis was administered by face-to-face interview. Use of CAM therapies, beliefs, communication with physician. 63% used at least one CAM therapy, with an average use of two therapies per patient. Men were significantly less likely to use a therapy than women; women were more likely to use numerous therapies. Cancer diagnosis seems to have had no influence overall on the frequency of use of CAM therapies. The major reasons stated for CAM use were for treatment-related medical conditions as well as depression, anxiety, and insomnia. The most frequently reported therapies were spiritual, relaxation, imagery, exercise, lifestyle diet (e.g., macrobiotic, vegetarian), and nutritional supplementation. Patients unanimously believed that these complementary therapies helped to improve their quality of life through more effective coping with stress, decreasing the discomforts of treatment and illness, and giving them a sense of control. Patients with cancer use various complementary therapies to cope with their disease and the rigors of clinical trials. Women and those with higher educational backgrounds were more frequent users. Nurses who provide care to subjects of biomedical research have an opportunity and responsibility regarding their patients' use of CAM therapies. Nurses may use in-house resources to help evaluate subjects' use of a CAM modality or to provide quality-of-life therapies such as relaxation, imagery, or

  7. Efficacy and Safety of Traditional Chinese Medicine for Diabetes: A Double-Blind, Randomised, Controlled Trial

    PubMed Central

    Ji, Linong; Tong, Xiaolin; Wang, Hongyuan; Tian, Haoming; Zhou, Huimin; Zhang, Lili; Li, Qifu; Wang, Yizhong; Li, Hongmei; Liu, Min; Yang, Hongjie; Gao, Yanbin; Li, Yan; Li, Quanmin; Guo, Xiaohui; Yang, Gangyi; Zhang, Zhongai; Zhou, Zhiguang; Ning, Guang; Chen, Yingli; Paul, Sanjoy

    2013-01-01

    Background Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history. The aim of this study is to establish the safety and efficacy of traditional Chinese medicine combined with glibenclamide to treat type 2 diabetes mellitus. Methods In a controlled, double blind, multicentre non-inferiority trial, 800 patients with unsatisfactory glycemic control (fasting glucose 7–13 mmol/L and HbA1c 7–11%) were randomly assigned to receive Xiaoke Pill, a compound of Chinese herbs combined with glibenclamide, or Glibenclamide in two study groups – drug naive group, and patients previously treated with metformin monotherapy (metformin group). Outcome measures at 48 weeks were the incidence and rate of hypoglycemia, mean difference in HbA1c, and proportion of patients with HbA1c<6.5%. Findings In drug naïve group, the total hypoglycemia rate and the mild hypoglycemic episode in the Xiaoke Pill arm were 38% (p = 0.024) and 41% (p = 0.002) less compared to Glibenclamide arm; in Metformin group, the average annual rate of hypoglycemia was 62% lower in Xiaoke Pill arm (p = 0.003). Respective mean changes in HbA1c from baseline were −0.70% and −0.66% for Xiaoke Pill and Glibenclamide, with a between-group difference (95% CI) of −0.04% (−0.20, 0.12) in the drug naïve group, and those in metformin group were −0.45% and −0.59%, 0.14% (−0.12, 0.39) respectively. The respective proportions of patients with a HbA1c level <6.5% were 26.6% and 23.4% in the drug naïve group and 20.1% and 18.9% in the metformin group. Interpretation In patients with type 2 diabetes and inadequate glycaemic control, treatment with Xiaoke Pill led to significant reduction in risk of hypoglycemia and similar improvements in glycemic control after 48 weeks compared to Glibenclamide. Trial Registration Chinese Clinical Trial Register number, ChiCTR-TRC-08000074 PMID:23460810

  8. Launch vehicles

    NASA Astrophysics Data System (ADS)

    Moss, J. B.

    The basic principles which determine launcher design and hence constrain the spacecraft payload are determined. Some key features of the principal launcher alternatives in Europe and the U.S., namely, the unmanned, expendable Ariane and the manned, substantially reusable, Space Shuttle, are outlined. The equations of motion of the rocket are specialized to the vertical plane, parallel and normal to the flight direction, and to the motion of the center of mass and the pitch rotation. A typical Ariane 2 flight profile for transfer into GTO is illustrated. Some representative mission requirements for spacecraft launches are reviewed. Launch vehicle burnout velocities for spacecraft emplacement are given. Geostationary orbit emplacement, orbital mission performance, and configuration interactions are discussed.

  9. LADEE Launch

    NASA Image and Video Library

    2013-09-07

    NASA's Lunar Atmosphere and Dust Environment Explorer (LADEE) observatory launches aboard the Minotaur V rocket from the Mid-Atlantic Regional Spaceport (MARS) at NASA's Wallops Flight Facility, Friday, Sept. 6, 2013 in Virginia. LADEE is a robotic mission that will orbit the moon where it will provide unprecedented information about the environment around the moon and give scientists a better understanding of other planetary bodies in our solar system and beyond. Photo Credit: (NASA/Carla Cioffi)

  10. Launch Vehicles

    NASA Image and Video Library

    2004-04-15

    The Titan II liftoff. The Titan II launch vehicle was used for carrying astronauts on the Gemini mission. The Gemini Program was an intermediate step between the Project Mercury and the Apollo Program. The major objectives were to subject are two men and supporting equipment to long duration flights, to effect rendezvous and docking with other orbiting vehicle, and to perfect methods of reentry, and landing the spacecraft.

  11. Launch Vehicles

    NASA Image and Video Library

    2007-07-09

    Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. In this HD video image, an Ares I x-test involves the upper stage separating from the first stage. This particular test was conducted at the NASA Langley Research Center in July 2007. (Highest resolution available)

  12. Medicines

    MedlinePlus

    ... better. In the United States, the Food and Drug Administration is in charge of assuring the safety ... prescription and over-the-counter medicines. Even safe drugs can cause unwanted side effects or interactions with ...

  13. Improving the quality of randomized controlled trials in Chinese herbal medicine, part II: control group design.

    PubMed

    Bian, Zhao-Xiang; Moher, David; Dagenais, Simon; Li, You-Ping; Liu, Liang; Wu, Tai-Xiang; Miao, Jiang-Xia

    2006-03-01

    To discuss the types of control groups in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the design of control group in future clinical studies in this therapeutic area. A search of the Cochrane Library was conducted in July 2005 to identify RCTs of CHM, and 66 RCTs with CHM for type 2 diabetes mellitus were obtained as the basis for further analysis. Of 66 RCTs with CHM for type 2 diabetes mellitus, 61 (92.4%) trials had both a treatment group and a control group. Twenty-seven (40.9%) RCTs compared CHM plus conventional drug vs conventional drug, 24 (36.4%) compared CHM vs conventional drug, 5 (7.6%) compared CHM vs placebo, 3 (4.5%) compared CHM plus conventional drug vs conventional drug plus placebo, 3 (4.5%) compared CHM plus conventional drug vs other CHM, 1 (1.5%) compared CHM vs no treatment, 1 (1.5%) compared CHM plus placebo vs conventional drug plus placebo, 1 (1.5%) compared CHM vs CHM plus conventional drug vs conventional drug vs placebo, and 1 (1.5%) compared CHM vs conventional drug vs CHM plus conventional drug. A variety of control groups were used in RCTs of CHM for type 2 diabetes mellitus, including placebo, active, and no treatment control groups. Justification for selecting particular types of control groups were not provided in the trials reviewed in this study. Different control groups may be appropriate according to the study objectives, and several factors should be considered prior to selecting control groups in future RCTs of CHM. (1) Investigators of CHM who design clinical trials should understand the rationale for selecting different types of control groups; (2) Control groups for RCTs should be selected according to study objectives; (3) Active control groups should select interventions for comparisons that have the strongest evidence of efficacy and prescribe them as recommended; (4) Placebo control groups should select a placebo that mimics the physical

  14. Time required to start multicentre clinical trials within the Italian Medicine Agency programme of support for independent research.

    PubMed

    De Feo, Gianfranco; Frontini, Luciano; Rota, Silvia; Pepe, Antonio; Signoriello, Simona; Labianca, Roberto; Sobrero, Alberto; De Placido, Sabino; Perrone, Francesco

    2015-10-01

    Time allowed for independent ethics committees (IECs) and administrative offices to assess and activate clinical trials is regulated by law. This study aims to describe time spent activating two multicentre non-profit trials supported by the Italian Medicines Agency (AIFA). Five non-AIFA supported (NAS) trials were used as a benchmark. The two AIFA-supported trials were FATA-GIM3 (optimal adjuvant hormonal treatment for breast cancer) and TOSCA (duration of adjuvant FOLFOX in colorectal cancer). The five NAS trials focused on lung or ovarian cancer. The following were measured for all trials: date of submission of trial documentation to peripheral IEC, date of IEC opinion and date trial contracts were signed. Times are reported in months. 106 centres applied to participate in FATA-GIM3 and 137 in TOSCA. An IEC opinion was issued by 100/106 (1 negative opinion) and 137/137 (2 negative opinions) centres, with a median time from submission of 3.6 months (range 0.1-60.2). After a positive IEC opinion, the median time before signing the trial contract was 3.3 months (0.1-59.2). Contracts were signed with 93/99 and 135/135 centres, with a median time from submission of study documentation of 8.4 months (0.5-61.1). Times for NAS trials were not substantially different. FATA-GIM3 and TOSCA centres were opened after a median of 8 months, consisting of nearly 4 months each for IEC opinion and administrative signature, similar to the NAS trials. The process of trial activation in Italy remains inefficient and takes far longer than legally allowed. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  15. The synergy of the whole: building a global system for clinical trials to accelerate medicines development.

    PubMed

    Koski, Greg; Tobin, Mary F; Whalen, Matthew

    2014-10-01

    The pharmaceutical industry, once highly respected, productive, and profitable, is in the throes of major change driven by many forces, including economics, science, regulation, and ethics. A variety of initiatives and partnerships have been launched to improve efficiency and productivity but without significant effect because they have failed to consider the process as a system. Addressing the challenges facing this complex endeavor requires more than modifications of individual processes; it requires a fully integrated application of systems thinking and an understanding of the desired goals and complex interactions among essential components and stakeholders of the whole. A multistakeholder collaborative effort, led by the Alliance for Clinical Research Excellence and Safety (ACRES), a global nonprofit organization operating in the public interest, is now under way to build a shared global system for clinical research. Its systems approach focuses on the interconnection of stakeholders at critical points of interaction within 4 operational domains: site development and support, quality management, information technology, and safety. The ACRES initiatives, Site Accreditation and Standards, Product Safety Culture, Global Ethical Review and Regulatory Innovation, and Quality Assurance and Safety, focus on building and implementing systems solutions. Underpinning these initiatives is an open, shared, integrated technology (site and optics and quality informatics initiative). We describe the rationale, challenges, progress, and successes of this effort to date and lessons learned. The complexity and fragmentation of the intensely proprietary ecosystem of drug development, challenging regulatory climate, and magnitude of the endeavor itself pose significant challenges, but the economic, social, and scientific rewards will more than justify the effort. An effective alliance model requires a willingness of multiple stakeholders to work together to build a shared system

  16. Launch Vehicles

    NASA Image and Video Library

    2007-08-09

    Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. This HD video image depicts the preparation and placement of a confidence ring for friction stir welding used in manufacturing aluminum panels that will fabricate the Ares I upper stage barrel. The aluminum panels are manufactured and subjected to confidence tests during which the bent aluminum is stressed to breaking point and thoroughly examined. The panels are manufactured by AMRO Manufacturing located in El Monte, California. (Highest resolution available)

  17. Launch Vehicles

    NASA Image and Video Library

    2006-09-09

    Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. In this HD video image, the first stage reentry parachute drop test is conducted at the Yuma, Arizona proving ground. The parachute tests demonstrated a three-stage deployment sequence that included the use of an Orbiter drag chute to properly stage the unfurling of the main chute. The parachute recovery system for Orion will be similar to the system used for Apollo command module landings and include two drogue, three pilot, and three main parachutes. (Highest resolution available)

  18. Launch Vehicles

    NASA Image and Video Library

    2007-09-09

    Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. In this HD video image, the first stage reentry parachute drop test is conducted at the Yuma, Arizona proving ground. The parachute tests demonstrated a three-stage deployment sequence that included the use of an Orbiter drag chute to properly stage the unfurling of the main chute. The parachute recovery system for Orion will be similar to the system used for Apollo command module landings and include two drogue, three pilot, and three main parachutes. (Highest resolution available)

  19. Launch Vehicles

    NASA Image and Video Library

    2007-08-09

    Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. In this HD video image, processes for upper stage barrel fabrication are talking place. Aluminum panels are manufacturing process demonstration articles that will undergo testing until perfected. The panels are built by AMRO Manufacturing located in El Monte, California. (Largest resolution available)

  20. Launch Vehicles

    NASA Image and Video Library

    2007-08-09

    Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. This HD video image depicts the manufacturing of aluminum panels that will be used to form the Ares I barrel. The panels are manufacturing process demonstration articles that will undergo testing until perfected. The panels are built by AMRO Manufacturing located in El Monte, California. (Highest resolution available)

  1. Launch Vehicles

    NASA Image and Video Library

    2007-08-09

    Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. This HD video image depicts friction stir welding used in manufacturing aluminum panels that will fabricate the Ares I upper stage barrel. The panels are subjected to confidence tests in which the bent aluminum is stressed to breaking point and thoroughly examined. The panels are manufactured by AMRO Manufacturing located in El Monte, California. (Highest resolution available)

  2. Launch Vehicles

    NASA Image and Video Library

    2007-08-09

    Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. This HD video image, depicts a manufactured aluminum panel, that will be used to fabricate the Ares I upper stage barrel, undergoing a confidence panel test. In this test, the bent aluminum is stressed to breaking point and thoroughly examined. The panels are manufactured by AMRO Manufacturing located in El Monte, California. (Highest resolution available)

  3. Launch Vehicles

    NASA Image and Video Library

    2006-08-08

    Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. This HD video image depicts a manufactured aluminum panel that will be used to fabricate the Ares I upper stage barrel, undergoing a confidence panel test. In this test, the bent aluminum is stressed to breaking point and thoroughly examined. The panels are manufactured by AMRO Manufacturing located in El Monte, California. (Highest resolution available)

  4. Launch Vehicles

    NASA Image and Video Library

    2007-08-09

    Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. This HD video image depicts confidence testing of a manufactured aluminum panel that will fabricate the Ares I upper stage barrel. In this test, bent aluminum is stressed to breaking point and thoroughly examined. The panels are manufactured by AMRO Manufacturing located in El Monte, California. (Highest resolution available)

  5. Launch Vehicles

    NASA Image and Video Library

    2006-08-09

    Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. This HD video image depicts a manufactured aluminum panel, that will fabricate the Ares I upper stage barrel, undergoing a confidence panel test. In this test, bent aluminum is stressed to breaking point and thoroughly examined. The panels are manufactured by AMRO Manufacturing located in El Monte, California. (Highest resolution available)

  6. Launch Vehicles

    NASA Image and Video Library

    2007-08-09

    Under the goals of the Vision for Space Exploration, Ares I is a chief component of the cost-effective space transportation infrastructure being developed by NASA's Constellation Program. This transportation system will safely and reliably carry human explorers back to the moon, and then onward to Mars and other destinations in the solar system. The Ares I effort includes multiple project element teams at NASA centers and contract organizations around the nation, and is managed by the Exploration Launch Projects Office at NASA's Marshall Space Flight Center (MFSC). ATK Launch Systems near Brigham City, Utah, is the prime contractor for the first stage booster. ATK's subcontractor, United Space Alliance of Houston, is designing, developing and testing the parachutes at its facilities at NASA's Kennedy Space Center in Florida. NASA's Johnson Space Center in Houston hosts the Constellation Program and Orion Crew Capsule Project Office and provides test instrumentation and support personnel. Together, these teams are developing vehicle hardware, evolving proven technologies, and testing components and systems. Their work builds on powerful, reliable space shuttle propulsion elements and nearly a half-century of NASA space flight experience and technological advances. Ares I is an inline, two-stage rocket configuration topped by the Crew Exploration Vehicle, its service module, and a launch abort system. This HD video image depicts a manufactured aluminum panel, that will fabricate the Ares I upper stage barrel, undergoing a confidence panel test. In this test, the bent aluminum is stressed to breaking point and thoroughly examined. The panels are manufactured by AMRO Manufacturing located in El Monte, California. (Highest resolution available)

  7. New medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessment.

    PubMed

    Cowie, Martin R; Filippatos, Gerasimos S; Alonso Garcia, Maria de Los Angeles; Anker, Stefan D; Baczynska, Anna; Bloomfield, Daniel M; Borentain, Maria; Bruins Slot, Karsten; Cronin, Maureen; Doevendans, Pieter A; El-Gazayerly, Amany; Gimpelewicz, Claudio; Honarpour, Narimon; Janmohamed, Salim; Janssen, Heidi; Kim, Albert M; Lautsch, Dominik; Laws, Ian; Lefkowitz, Martin; Lopez-Sendon, Jose; Lyon, Alexander R; Malik, Fady I; McMurray, John J V; Metra, Marco; Figueroa Perez, Santiago; Pfeffer, Marc A; Pocock, Stuart J; Ponikowski, Piotr; Prasad, Krishna; Richard-Lordereau, Isabelle; Roessig, Lothar; Rosano, Giuseppe M C; Sherman, Warren; Stough, Wendy Gattis; Swedberg, Karl; Tyl, Benoit; Zannad, Faiez; Boulton, Caroline; De Graeff, Pieter

    2017-03-27

    Despite the availability of a number of different classes of therapeutic agents with proven efficacy in heart failure, the clinical course of heart failure patients is characterized by a reduction in life expectancy, a progressive decline in health-related quality of life and functional status, as well as a high risk of hospitalization. New approaches are needed to address the unmet medical needs of this patient population. The European Medicines Agency (EMA) is undertaking a revision of its Guideline on Clinical Investigation of Medicinal Products for the Treatment of Chronic Heart Failure. The draft version of the Guideline was released for public consultation in January 2016. The Cardiovascular Round Table of the European Society of Cardiology (ESC), in partnership with the Heart Failure Association of the ESC, convened a dedicated two-day workshop to discuss three main topic areas of major interest in the field and addressed in this draft EMA guideline: (i) assessment of efficacy (i.e. endpoint selection and statistical analysis); (ii) clinical trial design (i.e. issues pertaining to patient population, optimal medical therapy, run-in period); and (iii) research approaches for testing novel therapeutic principles (i.e. cell therapy). This paper summarizes the key outputs from the workshop, reviews areas of expert consensus, and identifies gaps that require further research or discussion. Collaboration between regulators, industry, clinical trialists, cardiologists, health technology assessment bodies, payers, and patient organizations is critical to address the ongoing challenge of heart failure and to ensure the development and market access of new therapeutics in a scientifically robust, practical and safe way.

  8. Efficacy and safety of traditional chinese medicine for diabetes: a double-blind, randomised, controlled trial.

    PubMed

    Ji, Linong; Tong, Xiaolin; Wang, Hongyuan; Tian, Haoming; Zhou, Huimin; Zhang, Lili; Li, Qifu; Wang, Yizhong; Li, Hongmei; Liu, Min; Yang, Hongjie; Gao, Yanbin; Li, Yan; Li, Quanmin; Guo, Xiaohui; Yang, Gangyi; Zhang, Zhongai; Zhou, Zhiguang; Ning, Guang; Chen, Yingli; Paul, Sanjoy

    2013-01-01

    Treatment of diabetes mellitus with Traditional Chinese Medicine has a long history. The aim of this study is to establish the safety and efficacy of traditional Chinese medicine combined with glibenclamide to treat type 2 diabetes mellitus. In a controlled, double blind, multicentre non-inferiority trial, 800 patients with unsatisfactory glycemic control (fasting glucose 7-13 mmol/L and HbA1c 7-11%) were randomly assigned to receive Xiaoke Pill, a compound of Chinese herbs combined with glibenclamide, or Glibenclamide in two study groups - drug naive group, and patients previously treated with metformin monotherapy (metformin group). Outcome measures at 48 weeks were the incidence and rate of hypoglycemia, mean difference in HbA1c, and proportion of patients with HbA1c<6.5%. In drug naïve group, the total hypoglycemia rate and the mild hypoglycemic episode in the Xiaoke Pill arm were 38% (p = 0.024) and 41% (p = 0.002) less compared to Glibenclamide arm; in Metformin group, the average annual rate of hypoglycemia was 62% lower in Xiaoke Pill arm (p = 0.003). Respective mean changes in HbA1c from baseline were -0.70% and -0.66% for Xiaoke Pill and Glibenclamide, with a between-group difference (95% CI) of -0.04% (-0.20, 0.12) in the drug naïve group, and those in metformin group were -0.45% and -0.59%, 0.14% (-0.12, 0.39) respectively. The respective proportions of patients with a HbA1c level <6.5% were 26.6% and 23.4% in the drug naïve group and 20.1% and 18.9% in the metformin group. In patients with type 2 diabetes and inadequate glycaemic control, treatment with Xiaoke Pill led to significant reduction in risk of hypoglycemia and similar improvements in glycemic control after 48 weeks compared to Glibenclamide. Chinese Clinical Trial Register number, ChiCTR-TRC-08000074.

  9. Factors Influencing Participation in Clinical Trials: Emergency Medicine vs. Other Specialties

    PubMed Central

    Kurt, Anita; Kincaid, Hope M.; Curtis, Charity; Semler, Lauren; Meyers, Matthew; Johnson, Melanie; Careyva, Beth A.; Stello, Brian; Friel, Timothy J.; Knouse, Mark C.; Smulian, John C.; Jacoby, Jeanne L.

    2017-01-01

    Introduction This study investigated factors that influence emergency medicine (EM) patients’ decisions to participate in clinical trials and whether the impact of these factors differs from those of other medical specialties. Methods A survey was distributed in EM, family medicine (FM), infectious disease (ID), and obstetrics/gynecology (OB/GYN) outpatient waiting areas. Eligibility criteria included those who were 18 years of age or older, active patients on the day of the survey, and able to complete the survey without assistance. We used the Kruskal-Wallis test and ordinal logistic regression analyses to identify differences in participants’ responses. Results A total of 2,893 eligible subjects were approached, and we included 1,841 surveys in the final analysis. Statistically significant differences (p≤0.009) were found for eight of the ten motivating factors between EM and one or more of the other specialties. Regardless of a patient’s gender, race, and education, the relationship with their doctor was more motivating to patients seen in other specialties than to EM patients (FM [odds ratio {OR}:1.752, 95% confidence interval {CI}{1.285–2.389}], ID [OR:3.281, 95% CI{2.293–4.695}], and OB/GYN [OR:2.408, 95% CI{1.741–3.330}]). EM’s rankings of “how well the research was explained” and whether “the knowledge learned would benefit others” as their top two motivating factors were similar across other specialties. All nine barriers showed statistically significant differences (p≤0.008) between EM and one or more other specialties. Participants from all specialties indicated “risk of unknown side effects” as their strongest barrier. Regardless of the patients’ race, “time commitment” was considered to be more of a barrier to other specialties when compared to EM (FM [OR:1.613, 95% CI{1.218–2.136}], ID [OR:1.340, 95% CI{1.006–1.784}], or OB/GYN [OR:1.901, 95% CI{1.431–2.526}]). Among the six resources assessed that help

  10. Exploring integrative medicine for back and neck pain - a pragmatic randomised clinical pilot trial

    PubMed Central

    Sundberg, Tobias; Petzold, Max; Wändell, Per; Rydén, Anna; Falkenberg, Torkel

    2009-01-01

    Background A model for integrative medicine (IM) adapted to Swedish primary care was previously developed. The aim of this study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain. Specific objectives included the exploration of recruitment and retention rates, patient and care characteristics, clinical differences and effect sizes between groups, selected outcome measures and power calculations to inform the basis of a full-scale trial. Methods Eighty patients with back/neck pain of at least two weeks duration were randomised to the two types of care. Outcome measures were standardised health related quality of life (the eight domains of SF-36) complemented by a set of exploratory "IM tailored" outcomes targeting self-rated disability, stress and well-being (0-10 scales); days in pain (0-14); and the use of analgesics and health care over the last two weeks (yes/no). Data on clinical management were derived from medical records. Outcome changes from baseline to follow-up after 16 weeks were used to explore the differences between the groups. Results Seventy-five percent (80/107) of screened patients in general practice were eligible and feasible to enrol into the trial. Eighty-two percent (36/44) of the integrative and 75% (27/36) of the conventional care group completed follow-up after 16 weeks. Most patients had back/neck pain of at least three months duration. Conventional care typically comprised advice and prescription of analgesics, occasionally complemented with sick leave or a written referral to physiotherapy. IM care generally integrated seven treatment sessions from two different types of complementary therapies with conventional care over ten weeks. The study was underpowered to detect any statistically significant differences between the groups. One SF-36 domain showed a clinically

  11. Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial

    PubMed Central

    Jordan, Susan; Gabe-Walters, Marie Ellenor; Watkins, Alan; Humphreys, Ioan; Newson, Louise; Snelgrove, Sherrill; Dennis, Michael S

    2015-01-01

    Background People with dementia are susceptible to adverse drug reactions (ADRs). However, they are not always closely monitored for potential problems relating to their medicines: structured nurse-led ADR Profiles have the potential to address this care gap. We aimed to assess the number and nature of clinical problems identified and addressed and changes in prescribing following introduction of nurse-led medicines’ monitoring. Design Pragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT) of structured nurse-led medicines’ monitoring versus usual care. Setting Five UK private sector care homes Participants 41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine. Intervention Nurses completed the West Wales ADR (WWADR) Profile for Mental Health Medicines with each participant according to trial step. Outcomes Problems addressed and changes in medicines prescribed. Data Collection and Analysis Information was collected from participants’ notes before randomisation and after each of five monthly trial steps. The impact of the Profile on problems found, actions taken and reduction in mental health medicines was explored in multivariate analyses, accounting for data collection step and site. Results Five of 10 sites and 43 of 49 service users approached participated. Profile administration increased the number of problems addressed from a mean of 6.02 [SD 2.92] to 9.86 [4.48], effect size 3.84, 95% CI 2.57–4.11, P <0.001. For example, pain was more likely to be treated (adjusted Odds Ratio [aOR] 3.84, 1.78–8.30), and more patients attended dentists and opticians (aOR 52.76 [11.80–235.90] and 5.12 [1.45–18.03] respectively). Profile use was associated with reduction in mental health medicines (aOR 4.45, 1.15–17.22). Conclusion The WWADR Profile for Mental Health Medicines can improve the quality and safety of care, and warrants further investigation as a strategy to mitigate the known adverse

  12. Naturopathic medicine for the prevention of cardiovascular disease: a randomized clinical trial.

    PubMed

    Seely, Dugald; Szczurko, Orest; Cooley, Kieran; Fritz, Heidi; Aberdour, Serenity; Herrington, Craig; Herman, Patricia; Rouchotas, Philip; Lescheid, David; Bradley, Ryan; Gignac, Tara; Bernhardt, Bob; Zhou, Qi; Guyatt, Gordon

    2013-06-11

    Although cardiovascular disease may be partially preventable through dietary and lifestyle-based interventions, few individuals at risk receive intensive dietary and lifestyle counselling. We performed a randomized controlled trial to evaluate the effectiveness of naturopathic care in reducing the risk of cardiovascular disease. We performed a multisite randomized controlled trial of enhanced usual care (usual care plus biometric measurement; control) compared with enhanced usual care plus naturopathic care (hereafter called naturopathic care). Postal workers aged 25-65 years in Toronto, Vancouver and Edmonton, Canada, with an increased risk of cardiovascular disease were invited to participate. Participants in both groups received care by their family physicians. Those in the naturopathic group also received individualized care (health promotion counselling, nutritional medicine or dietary supplementation) at 7 preset times in work-site clinics by licensed naturopathic doctors. The body weight, waist circumference, lipid profile, fasting glucose levels and blood pressure of participants in both groups were measured 3 times during a 1-year period. Our primary outcomes were the 10-year risk of having a cardiovascular event (based on the Framingham risk algorithm) and the prevalence of metabolic syndrome (based on the Adult Treatment Panel III diagnostic criteria). Of 246 participants randomly assigned to a study group, 207 completed the study. The characteristics of participants in both groups were similar at baseline. Compared with participants in the control group, at 52 weeks those in the naturopathic group had a reduced adjusted 10-year cardiovascular risk (control: 10.81%; naturopathic group: 7.74%; risk reduction -3.07% [95% confidence interval (CI) -4.35% to -1.78%], p < 0.001) and a lower adjusted frequency of metabolic syndrome (control group: 48.48%; naturopathic care: 31.58%; risk reduction -16.90% [95% CI -29.55% to -4.25%], p = 0.002). Our findings

  13. A Randomized Controlled Trial of Chinese Medicine on Nonmotor Symptoms in Parkinson's Disease.

    PubMed

    Chua, Ka-Kit; Wong, Adrian; Chan, Kam-Wa; Lau, Yin-Kei; Bian, Zhao-Xiang; Lu, Jia-Hong; Liu, Liang-Feng; Chen, Lei-Lei; Chan, Ka-Ho; Tse, Kim-Pong; Chan, Anne; Song, Ju-Xian; Wu, Justin; Zhu, Li-Xing; Mok, Vincent; Li, Min

    2017-01-01

    Nonmotor symptoms (NMS) of Parkinson's disease (PD) have devastating impacts on both patients and their caregivers. Jiawei-Liujunzi Tang (JLT) has been used to treat some NMS of PD based on the Chinese medicine theory since Qing dynasty. Here we report a double-blind, randomized, placebo-controlled, add-on clinical trial aiming at evaluating the efficacy and safety of the JLT in treating NMS in PD patients. We randomly assigned 111 patients with idiopathic PD to receive either JLT or placebo for 32 weeks. Outcome measures were baseline to week 32 changes in Movement Disorder Society-Sponsored Revision of Unified PD Rating Scale (MDS-UPDRS) Parts I-IV and in NMS assessment scale for PD (NMSS). We observed improvements in the NMSS total score (p = 0.019), mood/cognition (p = 0.005), and reduction in hallucinations (p = 0.024). In addition, post hoc analysis showed a significant reduction in constipation (p < 0.001). However, there was no evidence of improvement in MDS-UPDRS Part I total score (p = 0.216) at week 32. Adverse events (AEs) were mild and comparable between the two groups. In conclusion, long-term administration of JLT is well tolerated and shows significant benefits in improving NMS including mood, cognition, and constipation.

  14. The Practice of Korean Medicine: An Overview of Clinical Trials in Acupuncture

    PubMed Central

    2005-01-01

    Acupuncture, one of the Oriental medical therapeutic techniques that can be traced back at least 2500 years, is growing in popularity all over the world. Korea has continued to develop its own unique tradition of medicine throughout its long history, and has formed different types of acupuncture methods. The purpose of this review is to summarize clinical case studies in acupuncture and related therapies, such as acupressure, electric acupuncture, auricular acupuncture and moxibustion in Korea. A survey of Korean journals revealed that a total of 124 studies were published from 1983 to 2001. Results obtained from the survey showed that most clinical studies using acupuncture, electric acupuncture, moxibustion and other traditional therapies could alleviate a relatively broad range of medical problems. However, it should be emphasized that almost all clinical case studies published in various local journals did not follow the ‘good clinical practice’ with respect to regulatory aspects. Since they were not conducted using the randomized double-blinded controls with a large sample size, all the results should be considered as therapeutic indications. This review is an attempt to show the scope of acupuncture in our country and the kind of diseases, after many years of clinical experience, that were deemed valid targets for clinical trials. PMID:16136212

  15. TRADITIONAL CHINESE MEDICINE COMBINED WITH HORMONE THERAPY TO TREAT PREMATURE OVARIAN FAILURE: A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS.

    PubMed

    Kou, Mei-Jing; Ding, Xiu-Fang; Chen, Jia-Xu; Liu, Yan; Liu, Yue-Yun

    2016-01-01

    This meta-analysis aimed to provide critically estimated evidence for the advantages and disadvantages of Chinese herbal medicines used for premature ovarian failure (POF), which could provide suggestions for rational treatments. The databases searched included MEDLINE, EMBASE, CNKI, VIP, China Dissertation Database, China Important Conference Papers Database, and online clinical trial registry websites. Published and unpublished randomized controlled trials of traditional Chinese medicine (TCM) combined with hormone therapy (HT) and HT alone for POF were assessed up to December 30, 2015. Two authors extracted data and assessed trial quality independently using Cochrane systematic review methods. Meta-analysis was used to quantitatively describe serum hormone levels and Kupperman scores associated with perimenopause symptoms. Seventeen randomized controlled trials involving 1352 participants were selected. Compared with HT alone, although no significant effects were observed in the levels of luteinizing hormone, therapy with TCM combined with HT compared to HT alone effectively altered serum hormone levels of follicle stimulating hormone (P<0.01) and estradiol (P < 0.01), and improved Kupperman index scores (P< 0.01). The reported favorable effects of TCM combined with HT for treating POF patients are better than HT alone.However, the beneficial effects derived from this combination therapy cannot be viewed conclusive. In order to better support the clinical use, more rigorously designed trials are required to provide.

  16. Coordination and Management of Multisite Complementary and Alternative Medicine (CAM) Therapies: Experience from a Multisite Reflexology Intervention Trial

    PubMed Central

    Rahbar, Mohammad H.; Wyatt, Gwen; Sikorskii, Alla; Victorson, David; Ardjomand-Hessabi, Manouchehr

    2011-01-01

    Background Multisite randomized clinical trials allow for increased research collaboration among investigators and expedite data collection efforts. As a result, government funding agencies typically look favorably upon this approach. As the field of complementary and alternative medicine (CAM) continues to evolve, so do increased calls for the use of more rigorous study design and trial methodologies, which can present challenges for investigators. Purpose To describe the processes involved in the coordination and management of a multisite randomized clinical trial of a CAM intervention. Methods Key aspects related to the coordination and management of a multisite CAM randomized clinical trial are presented, including organizational and site selection considerations, recruitment concerns and issues related to data collection and randomization to treatment groups. Management and monitoring of data, as well as quality assurance procedures are described. Finally, a real world perspective is shared from a recently conducted multisite randomized clinical trial of reflexology for women diagnosed with advanced breast cancer. Results The use of multiple sites in the conduct of CAM-based randomized clinical trials can provide an efficient, collaborative and robust approach to study coordination and data collection that maximizes efficiency and ensures the quality of results. Conclusions Multisite randomized clinical trial designs can offer the field of CAM research a more standardized and efficient approach to examine the effectiveness of novel therapies and treatments. Special attention must be given to intervention fidelity, consistent data collection and ensuring data quality. Assessment and reporting of quantitative indicators of data quality should be required. PMID:21664296

  17. [Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials].

    PubMed

    Xie, Yanming; Wang, Yanping; Tian, Feng; Wang, Yongyan

    2011-10-01

    As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.

  18. Use of Rorschach tests at the Nuremberg war crimes trial: A forgotten chapter in history of medicine.

    PubMed

    Dimsdale, Joel E

    2015-06-01

    Seventy years ago, psychiatrists and psychologists had unusual access to the Nazi leaders awaiting trial by the International Military Tribunal in Nuremberg. Early leaders in the field of psychosomatic medicine were instrumental in facilitating these interviews as well as arranging for the administration of psychological testing with the Rorschach inkblot test. These observations were kept under wraps for decades and there remains controversy even now about what these Rorschachs revealed-demonic psychopaths or just morally corrupt individuals.

  19. Effects of a traditional herbal medicine on peripheral blood flow in women experiencing peripheral coldness: a randomized controlled trial.

    PubMed

    Nishida, Shinji; Eguchi, Eri; Ohira, Tetsuya; Kitamura, Akihiko; Kato, Yukiko Hakariya; Hagihara, Keisuke; Iso, Hiroyasu

    2015-04-02

    In Japan, a traditional herbal medicine, Tokishigyakukagoshuyushokyoto (TJ-38), is often used for the treatment of peripheral coldness, which is a common complaint among Japanese women. However, the effects of this herbal medicine have yet to be examined in a randomized controlled trial. In the current study, the effect of TJ-38 on the peripheral blood flow in women experiencing peripheral coldness was investigated using a parallel-group randomized controlled trial. Fifty-eight women aged 23 to 79 years with peripheral coldness were randomly divided into the intervention or control group. They were examined using cold bathing tests, physical examinations, and questionnaires in January 2010 for the baseline and in March 2010 for the follow-up, and January 2011 and March 2011, respectively. At the baseline, there were no differences in clinical characteristics between the two groups. In the intervention group, peripheral coldness improved after the intervention term; however, it persisted in the control group. Mean values of percentage recovery of the peripheral blood flow after cold bathing tests were 17.2% and -28.2% for the intervention and control groups, respectively (p = 0.007), and the proportions for percentage recovery of >50% were 32% and 0%, respectively (p = 0.0007). Mean values of percent recovery of skin temperature did not differ between the two groups. The present clinical trial supports that a traditional herbal medicine relieves peripheral coldness in women probably through the improvement of peripheral blood flow.

  20. Indispensable value of clinical trials in the modernization of traditional Chinese medicine: 12 years' experience at CUHK and future perspectives.

    PubMed

    Liang, Willmann; Yew, David T; Hon, Kam Lun; Wong, Chun Kwok; Kwok, Timothy C Y; Leung, Ping Chung

    2014-01-01

    The last decade has seen a wealth of information reporting the beneficial effects of Chinese herbal medicines. While a lot more studies were done using in vitro and in vivo research platforms, much fewer investigations were conducted according to evidence-based requirements in clinical settings. The Institute of Chinese Medicine at the Chinese University of Hong Kong (CUHK) has had the opportunity to collaborate with clinicians over the years to initiate and conduct dozens of clinical trials investigating and verifying the therapeutic values of Chinese herbs in selected disease conditions. Of the many disorders, we chose to focus on those that are known for their difficulties achieving perfect results with conventional treatment methods. Examples include non-healing ulcers, allergic conditions, degenerative diseases and cancer. Protective effects of the herbs in such chronic diseases as coronary artery disease and osteoporosis were also part of our focus. Even in healthy individuals and those recovering from chemotherapy, Chinese herbs could help with the immune system and were studied in our clinical trials as well. This paper aims to highlight the important findings from these clinical studies while at the same time, stressing the indispensable value of clinical trials in modernizing the use of Chinese herbs in present-day medicine.

  1. Complementary and alternative medicine in the treatment of pain in fibromyalgia: a systematic review of randomized controlled trials.

    PubMed

    Terhorst, Lauren; Schneider, Michael J; Kim, Kevin H; Goozdich, Lee M; Stilley, Carol S

    2011-09-01

    The purpose of this study was to systematically review the literature for randomized trials of complementary and alternative medicine (CAM) interventions for fibromyalgia (FM). A comprehensive literature search was conducted. Databases included the Cochrane library, PubMed, PsycINFO, Cumulative Index to Nursing and Allied Health, Natural Medicines Comprehensive Database Manual, Alternative and Natural Therapy Index System (MANTIS), Index for Chiropractic Literature, and Allied and Complementary Medicine (AMED). Inclusion criteria were (a) subjects were diagnosed with fibromyalgia and (b) the study design was a randomized controlled trial that compared a CAM therapy vs a control group. Studies were subgrouped by CAM treatment into 11 categories. Evidence tables and forest plots were organized to display quality ratings and effect sizes of each study. The literature search yielded 1,722 results; 102 abstracts were selected as potential articles for inclusion. Sixty studies met criteria and were rated by 2 reviewers; 18 were rated as good quality; 20, moderate; 18, low; and 4, very low. Synthesis of information for CAM categories represented by more than 5 studies revealed that balneotherapy and mind-body therapies were effective in treating FM pain. This study analyzed recent studies and focused exclusively on randomized controlled trials. Despite common use of manual therapies such as massage and manipulation to treat patients with FM, there is a paucity of quality clinical trials investigating these particular CAM categories. Most of these studies identified were preliminary or pilot studies, thus had small sample sizes and were likely underpowered. Two CAM categories showed the most promising findings, balneotherapy and mind-body therapies. Most of the other CAM categories showed a trend favoring the treatment group. It appears that several CAM therapies show some preliminary treatment effect for FM pain, but larger trials that are more adequately powered are

  2. Regulatory acceptance of animal models of disease to support clinical trials of medicines and advanced therapy medicinal products.

    PubMed

    Cavagnaro, Joy; Silva Lima, Beatriz

    2015-07-15

    The utility of animal models of disease for assessing the safety of novel therapeutic modalities has become an increasingly important topic of discussion as research and development efforts focus on improving the predictive value of animal studies to support accelerated clinical development. Medicines are approved for marketing based upon a determination that their benefits outweigh foreseeable risks in specific indications, specific populations, and at specific dosages and regimens. No medicine is 100% safe. A medicine is less safe if the actual risks are greater than the predicted risks. The purpose of preclinical safety assessment is to understand the potential risks to aid clinical decision-making. Ideally preclinical studies should identify potential adverse effects and design clinical studies that will minimize their occurrence. Most regulatory documents delineate the utilization of conventional "normal" animal species to evaluate the safety risk of new medicines (i.e., new chemical entities and new biological entities). Animal models of human disease are commonly utilized to gain insight into the pathogenesis of disease and to evaluate efficacy but less frequently utilized in preclinical safety assessment. An understanding of the limitations of the animal disease models together with a better understanding of the disease and how toxicity may be impacted by the disease condition should allow for a better prediction of risk in the intended patient population. Importantly, regulatory authorities are becoming more willing to accept and even recommend data from experimental animal disease models that combine efficacy and safety to support clinical development. Copyright © 2015 Elsevier B.V. All rights reserved.

  3. Teaching of evidence-based medicine to medical students in Mexico: a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Evidence-Based Medicine (EBM) is an important competency for the healthcare professional. Experimental evidence of EBM educational interventions from rigorous research studies is limited. The main objective of this study was to assess EBM learning (knowledge, attitudes and self-reported skills) in undergraduate medical students with a randomized controlled trial. Methods The educational intervention was a one-semester EBM course in the 5th year of a public medical school in Mexico. The study design was an experimental parallel group randomized controlled trial for the main outcome measures in the 5th year class (M5 EBM vs. M5 non-EBM groups), and quasi-experimental with static-groups comparisons for the 4th year (M4, not yet exposed) and 6th year (M6, exposed 6 months to a year earlier) groups. EBM attitudes, knowledge and self-reported skills were measured using Taylor’s questionnaire and a summative exam which comprised of a 100-item multiple-choice question (MCQ) test. Results 289 Medical students were assessed: M5 EBM=48, M5 non-EBM=47, M4=87, and M6=107. There was a higher reported use of the Cochrane Library and secondary journals in the intervention group (M5 vs. M5 non-EBM). Critical appraisal skills and attitude scores were higher in the intervention group (M5) and in the group of students exposed to EBM instruction during the previous year (M6). The knowledge level was higher after the intervention in the M5 EBM group compared to the M5 non-EBM group (p<0.001, Cohen's d=0.88 with Taylor's instrument and 3.54 with the 100-item MCQ test). M6 Students that received the intervention in the previous year had a knowledge score higher than the M4 and M5 non-EBM groups, but lower than the M5 EBM group. Conclusions Formal medical student training in EBM produced higher scores in attitudes, knowledge and self-reported critical appraisal skills compared with a randomized control group. Data from the concurrent groups add validity evidence to the study

  4. Does a 3-day workshop for family medicine trainees improve preventive care? A randomized control trial.

    PubMed

    Ward, J; Sanson-Fisher, R

    1996-01-01

    To evaluate the impact on clinical behavior of a 3-day workshop designed to increase trainees' rates of smoking cessation counseling and reminders about Pap smears in routine consultations. Randomized control trial. Accredited teaching practices of the Royal Australian College of General Practitioners' Training Program. Thirty-four trainees and 1,500 consecutive adult patients ages 16-65 years. Trainees randomly allocated to the experimental group participated in a 3-day interactive workshop on disease prevention during their 13-week family medicine term. Audiotapes of consultations with adults conducted by trainees at the beginning and end of the rotation were analyzed blind to compare assessment of patients' smoking status and, for women, date of last Pap smear. A questionnaire mailed to each patient after the consultation also allowed identification of smokers and women overdue for a smear. Consultations with these patients at risk were analyzed for preventive counseling. Inter- and intrarater reliability was calculated for audiotape analysis. Preworkshop rates of questions about smoking were low, occurring in 22% of consultations. While trainees allocated to the experimental workshop were more likely to ask a routine question about smoking at the end of the term than those in the control group (P = 0.01), two-thirds of smokers remained undetected irrespective of trainee group and fewer than one in five were advised to stop smoking. Reminders about Pap smears did not change as a result of training and remained low in fewer than 20% of consultations. kappa values demonstrated high reliability of audiotape analysis. This direct measurement of clinical behavior revealed that low levels of preventive care provided by trainees are resistant to skills training without reinforcement in clinical practice. In view of the importance of prevention in routine consultations, we recommend continued evaluation of more intensive educational programs. Those withstanding rigorous

  5. Effect of diet based on the principles of Iranian traditional medicine on cirrhosis (a clinical trial).

    PubMed

    Ehsani, Mohammad Javad; Mahdavi Jafari, Jamileh; Aliasl, Jale; Kamalinejad, Mohammad; Gachkar, Latif; Choopani, Rasool

    2016-12-01

    Cirrhosis is associated with morbidity and mortality worldwide. Iranian traditional medicine (ITM) focused on nutritional intervention in order to improve liver function. The aim of this study was to assess the effectiveness of a diet designed based on ITM and current dietary recommendations. This controlled trial study was performed on 57 subjects with cirrhosis in 5 tertiary hospitals in Teharn, Iran. Subjects were included if they were diagnosed with class A or B cirrhosis between October 2013 and December 2014. Subjects were randomly allocated into intervention (28 subjects) who received dietary and lifestyle recommendations based on ITM and controls (29 subjects) who received routine dietary and lifestyle recommendations for 3 months. Subjects were assessed at baseline and at the end of the intervention for anthropometric measures, liver function tests and cirrhosis severity scoring. Model for End-Stage Liver Disease (MELD), anthropometric measures, serum albumin, liver function tests, International Normalized Ratio and alkaline phosphatase as well as subjective findings. Mean age of the subjects was 51.19±11.88years. Weight reduction was observed in 41 subjects (22 subjects in intervention and 19 in control group). Dietary intervention resulted in a significant decrease in alanine aminotransferase (AST) (p=0.04) and significant resolution of icterus in sclera (p=0.02) in weight loss group and increase serum albumin in weight gain group (p=0.02). ITM recommendations could be beneficial for cirrhotic patients both for the purpose of weight reduction and weight gain. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. Endorsement for improving the quality of reports on randomized controlled trials of traditional medicine journals in Korea: a systematic review.

    PubMed

    Choi, Jiae; Jun, Ji Hee; Kang, Byoung Kab; Kim, Kun Hyung; Lee, Myeong Soo

    2014-11-05

    The aim of this study was to assess the endorsement of reporting guidelines in Korean traditional medicine (TM) journals by reviewing their instructions to authors. We examined the instructions to authors in all of the TM journals published in Korea to assess the appropriate use of reporting guidelines for research studies. The randomized controlled trials (RCTs) published after 2010 in journals that endorsed reporting guidelines were obtained. The reporting quality was assessed using the following guidelines: the 38-item Consolidated Standards of Reporting Trials (CONSORT) statement for non-pharmacological trials (NPT); the 17-item Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) statement, instead of the 5-item CONSORT for acupuncture trials; and the 22-item CONSORT extensions for herbal medicine trials. The overall item score was calculated and expressed as a proportion.One journal that endorsed reporting guidelines was identified. Twenty-nine RCTs published in this journal after 2010 met the selection criteria. General editorial policies such as those of the International Committee of Medical Journal Editors (ICMJE) were endorsed by 15 journals. In each of the CONSORT-NPT articles, 21.6 to 56.8% of the items were reported, with an average of 11.3 items (29.7%) being reported. In the 24 RCTs (24/29, 82.8%) appraised using the STRICTA items, an average of 10.6 items (62.5%) were addressed, with a range of 41.2 to 100%. For the herbal intervention reporting, 17 items (77.27%) were reported. In the RCT studies before and after the endorsement of CONSORT and STRICTA guidelines by each journal, all of the STRICTA items had significant improvement, whereas the CONSORT-NPT items improved without statistical significance.The endorsement of reporting guidelines is limited in the TM journals in Korea. Authors should adhere to the reporting guidelines, and editorial departments should refer authors to the various reporting guidelines to

  7. Epidemiology of clinical trials of medicines in respiratory diseases in Europe and Italy.

    PubMed

    Bodini, Roberta; Santus, Pierachille; Di Marco, Fabiano; Aliberti, Stefano; Centanni, Stefano; Blasi, Francesco; Rizzi, Andrea; Recchia, Giuseppe

    2017-04-01

    Clinical trials play a key role in advancing medical knowledge, improving patient care and promoting economic growth in Europe. We have assessed the clinical trial activity in any respiratory diseases in Europe, with a specific focus on Italy. Information from public sources (EFPIA, clinicaltrials.gov, clinicaltrialsregister. eu, AIFA) was used to describe clinical trial activity of in respiratory diseases in Europe and by country. In 2015, 3908 clinical trials were reported in Europe, 386 in respiratory diseases (9.9%). Germany was the first country both as absolute number (76 trials) and as percentage within country trials (14%), followed by Poland. Spain, Italy and France were the countries with the lowest number and percentage of trials in respiratory diseases. In 2013, the Italian Drug Agency reported 9 trials with respiratory compounds in Italy (2.1% of overall trials, 12ˆ position in the therapeutic area rank), 33% in phase 2 and 66% in phase 3. No phase 1 or phase 4 trials were reported for respiratory trials. Prevalence of respiratory trials by non-profit sponsors (28.3%) was below the average for the country (38.3%). Europe has a greater potential for clinical research on drugs for respiratory diseases, particularly in countries with less activity, such as Spain, France and Italy, that should identify and implement actions to increase attractiveness for clinical trials of drugs. Copyright © 2017 Elsevier Ltd. All rights reserved.

  8. Effect of a multimodality natural medicine program on carotid atherosclerosis in older subjects: a pilot trial of Maharishi Vedic Medicine.

    PubMed

    Fields, Jeremy Z; Walton, Kenneth G; Schneider, Robert H; Nidich, Sanford; Pomerantz, Rhoda; Suchdev, Parmi; Castillo-Richmond, Amparo; Payne, Kathleen; Clark, Elizabeth T; Rainforth, Maxwell

    2002-04-15

    Although the onset and progression of coronary heart disease (CHD) involve multiple risk factors, few intervention studies have attempted to modify these factors simultaneously. This pilot study tested the effect of a multimodality intervention involving dietary, exercise, herbal food supplement, and stress reduction approaches from a traditional system of natural medicine, Maharishi Vedic Medicine (MVM). The primary outcome measure was carotid intima-media thickness (IMT), a noninvasive measure of peripheral atherosclerosis and surrogate measure of coronary atherosclerosis. Comparison groups included modern medicine (conventional dietary, exercise, and multivitamin approaches) and usual care (no added intervention). Of 57 healthy seniors (mean age 74 years) randomized to the 3 treatment groups, 46 completed IMT post-testing. Carotid IMT was determined by B-mode ultrasound before and after 1 year of treatment. IMT decreased in a larger fraction of MVM subjects (16 of 20) than in the modern (5 of 9) and usual care (7 of 14) groups combined (i.e., 12 of 23; odds ratio 3.7, p = 0.05). For subjects with multiple CHD risk factors ("high-risk" subjects, n = 15), IMT decreased more in the MVM (-0.32 +/- 0.23 mm, mean +/- SD) than in the usual care (+0.022 +/- 0.085; p = 0.009) or modern (-0.082 +/- 0.095, p = 0.10) groups. Within-group reductions in IMT were significant for all MVM subjects (-0.15 +/- 0.21, n = 20, p = 0.004) and for high-risk MVM subjects (n = 6, p = 0.01). These results show that this multimodality traditional approach can attenuate atherosclerosis in older subjects, particularly those with marked CHD risk.

  9. Therapeutic Risk and Benefits of Concomitantly Using Herbal Medicines and Conventional Medicines: From the Perspectives of Evidence Based on Randomized Controlled Trials and Clinical Risk Management

    PubMed Central

    Zhang, Xiu-lai; Chen, Meng; Zhu, Ling-ling

    2017-01-01

    Despite increased awareness of the potential of herb-drug interactions (HDIs), the lack of rigorous clinical evidence regarding the significance provides a challenge for clinicians and consumers to make rational decisions about the safe combination of herbal and conventional medicines. This review addressed HDIs based on evidence from randomized controlled trials (RCTs). Literature was identified by performing a PubMed search till January 2017. Risk description and clinical risk management were described. Among 74 finally included RCTs, 17 RCTs (22.97%) simply addressed pharmacodynamic HDIs. Fifty-seven RCTs (77.03%) investigated pharmacokinetic HDIs and twenty-eight of them showed potential or actual clinical relevance. The extent of an HDI may be associated with the factors such as pharmacogenomics, dose of active ingredients in herbs, time course of interaction, characteristics of the object drugs (e.g., administration routes and pharmacokinetic profiles), modification of herbal prescription compositions, and coexistence of inducers and inhibitors. Clinical professionals should enhance risk management on HDIs such as increasing awareness of potential changes in therapeutic risk and benefits, inquiring patients about all currently used conventional medicines and herbal medicines and supplements, automatically detecting highly substantial significant HDI by computerized reminder system, selecting the alternatives, adjusting dose, reviewing the appropriateness of physician orders, educating patients to monitor for drug-interaction symptoms, and paying attention to follow-up visit and consultation. PMID:28491115

  10. Factors Affecting Recruitment and Attrition in Randomised Controlled Trials of Complementary and Alternative Medicine for Pregnancy-Related Issues

    PubMed Central

    2016-01-01

    Background. Randomised controlled trials (RCTs) investigating Complementary and Alternative Medicine (CAM) for pregnancy-related issues have encountered issues with recruitment and attrition. Little is known about the cause of these issues. Methods. Data was gathered from an antenatal CAM randomised controlled trial. During foetal anomaly appointments, women meeting inclusion criteria were invited to participate in the trial. Numbers of women invited and eligible were recorded. Reasons for noninterest were noted and analysed. Focus groups exploring trial experience of participants were also conducted. Findings. Of the 428 women invited to participate, 376 were eligible and just under a quarter participated. Reasons for nonparticipation included concerns about CAM and lack of interest in participation in research. Other factors negatively affecting recruitment included recruitment timing, competition for participants, limited support from staff, and inadequate trial promotion. Factors encouraging recruitment included being interested in research and seeking pain relief. Reasons for dropping out were time constraints, travel issues, work commitments, and pregnancy issues. Several women in the sham and usual care group dropped out due to dissatisfaction with treatment allocation. Conclusion. CAM researchers must explore problems encountered with recruitment and attrition so that evidence-based implementation strategies to address the issues can be developed. PMID:27956921

  11. Bayesian methodology for the design and interpretation of clinical trials in critical care medicine: a primer for clinicians.

    PubMed

    Kalil, Andre C; Sun, Junfeng

    2014-10-01

    To review Bayesian methodology and its utility to clinical decision making and research in the critical care field. Clinical, epidemiological, and biostatistical studies on Bayesian methods in PubMed and Embase from their inception to December 2013. Bayesian methods have been extensively used by a wide range of scientific fields, including astronomy, engineering, chemistry, genetics, physics, geology, paleontology, climatology, cryptography, linguistics, ecology, and computational sciences. The application of medical knowledge in clinical research is analogous to the application of medical knowledge in clinical practice. Bedside physicians have to make most diagnostic and treatment decisions on critically ill patients every day without clear-cut evidence-based medicine (more subjective than objective evidence). Similarly, clinical researchers have to make most decisions about trial design with limited available data. Bayesian methodology allows both subjective and objective aspects of knowledge to be formally measured and transparently incorporated into the design, execution, and interpretation of clinical trials. In addition, various degrees of knowledge and several hypotheses can be tested at the same time in a single clinical trial without the risk of multiplicity. Notably, the Bayesian technology is naturally suited for the interpretation of clinical trial findings for the individualized care of critically ill patients and for the optimization of public health policies. We propose that the application of the versatile Bayesian methodology in conjunction with the conventional statistical methods is not only ripe for actual use in critical care clinical research but it is also a necessary step to maximize the performance of clinical trials and its translation to the practice of critical care medicine.

  12. Automated confidence ranked classification of randomized controlled trial articles: an aid to evidence-based medicine

    PubMed Central

    Smalheiser, Neil R; McDonagh, Marian S; Yu, Clement; Adams, Clive E; Davis, John M; Yu, Philip S

    2015-01-01

    Objective: For many literature review tasks, including systematic review (SR) and other aspects of evidence-based medicine, it is important to know whether an article describes a randomized controlled trial (RCT). Current manual annotation is not complete or flexible enough for the SR process. In this work, highly accurate machine learning predictive models were built that include confidence predictions of whether an article is an RCT. Materials and Methods: The LibSVM classifier was used with forward selection of potential feature sets on a large human-related subset of MEDLINE to create a classification model requiring only the citation, abstract, and MeSH terms for each article. Results: The model achieved an area under the receiver operating characteristic curve of 0.973 and mean squared error of 0.013 on the held out year 2011 data. Accurate confidence estimates were confirmed on a manually reviewed set of test articles. A second model not requiring MeSH terms was also created, and performs almost as well. Discussion: Both models accurately rank and predict article RCT confidence. Using the model and the manually reviewed samples, it is estimated that about 8000 (3%) additional RCTs can be identified in MEDLINE, and that 5% of articles tagged as RCTs in Medline may not be identified. Conclusion: Retagging human-related studies with a continuously valued RCT confidence is potentially more useful for article ranking and review than a simple yes/no prediction. The automated RCT tagging tool should offer significant savings of time and effort during the process of writing SRs, and is a key component of a multistep text mining pipeline that we are building to streamline SR workflow. In addition, the model may be useful for identifying errors in MEDLINE publication types. The RCT confidence predictions described here have been made available to users as a web service with a user query form front end at: http://arrowsmith.psych

  13. Automated confidence ranked classification of randomized controlled trial articles: an aid to evidence-based medicine.

    PubMed

    Cohen, Aaron M; Smalheiser, Neil R; McDonagh, Marian S; Yu, Clement; Adams, Clive E; Davis, John M; Yu, Philip S

    2015-05-01

    For many literature review tasks, including systematic review (SR) and other aspects of evidence-based medicine, it is important to know whether an article describes a randomized controlled trial (RCT). Current manual annotation is not complete or flexible enough for the SR process. In this work, highly accurate machine learning predictive models were built that include confidence predictions of whether an article is an RCT. The LibSVM classifier was used with forward selection of potential feature sets on a large human-related subset of MEDLINE to create a classification model requiring only the citation, abstract, and MeSH terms for each article. The model achieved an area under the receiver operating characteristic curve of 0.973 and mean squared error of 0.013 on the held out year 2011 data. Accurate confidence estimates were confirmed on a manually reviewed set of test articles. A second model not requiring MeSH terms was also created, and performs almost as well. Both models accurately rank and predict article RCT confidence. Using the model and the manually reviewed samples, it is estimated that about 8000 (3%) additional RCTs can be identified in MEDLINE, and that 5% of articles tagged as RCTs in Medline may not be identified. Retagging human-related studies with a continuously valued RCT confidence is potentially more useful for article ranking and review than a simple yes/no prediction. The automated RCT tagging tool should offer significant savings of time and effort during the process of writing SRs, and is a key component of a multistep text mining pipeline that we are building to streamline SR workflow. In addition, the model may be useful for identifying errors in MEDLINE publication types. The RCT confidence predictions described here have been made available to users as a web service with a user query form front end at: http://arrowsmith.psych.uic.edu/cgi-bin/arrowsmith_uic/RCT_Tagger.cgi. © The Author 2015. Published by Oxford University Press on

  14. A randomised controlled trial of a blended learning education intervention for teaching evidence-based medicine.

    PubMed

    Ilic, Dragan; Nordin, Rusli Bin; Glasziou, Paul; Tilson, Julie K; Villanueva, Elmer

    2015-03-10

    Few studies have been performed to inform how best to teach evidence-based medicine (EBM) to medical trainees. Current evidence can only conclude that any form of teaching increases EBM competency, but cannot distinguish which form of teaching is most effective at increasing student competency in EBM. This study compared the effectiveness of a blended learning (BL) versus didactic learning (DL) approach of teaching EBM to medical students with respect to competency, self-efficacy, attitudes and behaviour toward EBM. A mixed methods study consisting of a randomised controlled trial (RCT) and qualitative case study was performed with medical students undertaking their first clinical year of training in EBM. Students were randomly assigned to receive EBM teaching via either a BL approach or the incumbent DL approach. Competency in EBM was assessed using the Berlin questionnaire and the 'Assessing Competency in EBM' (ACE) tool. Students' self-efficacy, attitudes and behaviour was also assessed. A series of focus groups was also performed to contextualise the quantitative results. A total of 147 students completed the RCT, and a further 29 students participated in six focus group discussions. Students who received the BL approach to teaching EBM had significantly higher scores in 5 out of 6 behaviour domains, 3 out of 4 attitude domains and 10 out of 14 self-efficacy domains. Competency in EBM did not differ significantly between students receiving the BL approach versus those receiving the DL approach [Mean Difference (MD)=-0.68, (95% CI-1.71, 0.34), p=0.19]. No significant difference was observed between sites (p=0.89) or by student type (p=0.58). Focus group discussions suggested a strong student preference for teaching using a BL approach, which integrates lectures, online learning and small group activities. BL is no more effective than DL at increasing medical students' knowledge and skills in EBM, but was significantly more effective at increasing student

  15. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine the efficacy and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with cervical radiculopathy. Methods/design A multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of the Qishe Pill is proposed. The study will include 240 patients from five sites across China and diagnosed with cervical radiculopathy, according to the following inclusion criteria: age 18 to 65 with pain or stiffness in the neck for at least 2 weeks (neck disability index score 25 or more) and accompanying arm pain that radiates distally from the elbow. Qualified participants will be randomly allocated into two groups: Qishe Pill group and placebo group. The prescription of the trial medications (Qishe Pill/placebo) are 3.75 g each twice a day for 28 consecutive days. The primary outcome is pain severity. Secondary outcomes are functional status, patient satisfaction, and adverse events as reported in the trial. Discussion Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus. According to modern research and preparation standards, Qishe Pill is developed to improve on the various symptoms of cervical radiculopathy, especially for neck pain. As it has a potential benefit in treating patients with neck pain, we designed a double-blind, prospective, randomized-controlled trial and

  16. Chinese medicine combined with calcipotriol betamethasone and calcipotriol ointment for Psoriasis vulgaris (CMCBCOP): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Psoriasis causes worldwide concern because of its high-prevalence, as well as its harmful, and incurable characteristics. Topical therapy is a conventional treatment for psoriasis vulgaris. Chinese medicine (CM) has been commonly used in an integrative way for psoriasis patients for many years. Some CM therapies have shown therapeutic effects for psoriasis vulgaris (PV), including relieving symptoms and improving quality of life, and may reduce the relapse rate. However, explicit evidence has not yet been obtained. The purpose of the present trial is to examine the efficacy and safety of the YXBCM01 granule, a compound Chinese herbal medicine, with a combination of topical therapy for PV patients. Methods/Design Using an add-on design, the trial is to evaluate whether the YXBCM01 granule combined topical therapy is more effective than topical therapy alone for the treatment of PV. The study design is a double-blind, parallel, randomized controlled trial comparing the YXBCM01 granule (5.5 g twice daily) to a placebo. The duration of treatment is 12 weeks. A total of 600 participants will be randomly allocated into two groups, YXBCM01 granule group and placebo group, from 11 general or dermatological hospitals in China. Topical use of calcipotriol betamethasone for the first 4 weeks and calcipotriol ointment for the remaining 8 weeks will be the same standard therapy for the two groups. Patients will be enrolled if they have a clinical diagnosis of PV, a psoriasis area severe index (PASI) of more than 10 or body surface area (BSA) of more than 10%, but PASI of less than 30 and BSA of less than 30%, are aged between 18 and 65-years-old, and provide signed informed consent. The primary outcome, relapse rate, is based on PASI assessed blindly during the treatment. Secondary outcomes include: (i) relapse time interval, (ii) time to onset, (iii) rebound rate, (iv) PASI score, (v) cumulative consumption of medicine, (vi) the dermatology quality life index

  17. Challenges and recommendations for placebo controls in randomized trials in physical and rehabilitation medicine: a report of the international placebo symposium working group.

    PubMed

    Fregni, Felipe; Imamura, Marta; Chien, Hsin Fen; Lew, Henry L; Boggio, Paulo; Kaptchuk, Ted J; Riberto, Marcelo; Hsing, Wu Tu; Battistella, Linamara Rizzo; Furlan, Andrea

    2010-02-01

    Compared with other specialties, the field of physical and rehabilitation medicine has not received the deserved recognition from clinicians and researchers in the scientific community. One of the reasons is the lack of sound evidence to support the traditional physical and rehabilitation medicine treatments. The best way to change this disadvantage is through a well conducted clinical research, such as standard placebo- or sham-controlled randomized clinical trials. Therefore, having placebo groups in clinical trials is essential to improve the level of evidence-based practice in physical and rehabilitation medicine that ultimately translates to better clinical care. To address the challenges for the use of placebo in physical and rehabilitation medicine and randomized clinical trials and to create useful recommendations, we convened a working group during the inaugural International Symposium in Placebo (February 2009, in Sao Paulo, Brazil) in which the following topics were discussed: (1) current status of randomized clinical trials in physical and rehabilitation medicine, (2) challenges for the use of placebo in physical and rehabilitation medicine, (3) bioethics, (4) use of placebo in acupuncture trials and for the treatment of low-back pain, (5) mechanisms of placebo, and (6) insights from other specialties. The current article represents the consensus report from the working group.

  18. Precision medicine at Memorial Sloan Kettering Cancer Center: clinical next-generation sequencing enabling next-generation targeted therapy trials

    PubMed Central

    Hyman, David M.; Solit, David B.; Arcila, Maria E.; Cheng, Donavan; Sabbatini, Paul; Baselga, Jose; Berger, Michael F.; Ladanyi, Marc

    2016-01-01

    Implementing a center-wide precision medicine strategy at a major cancer center is a true multidisciplinary effort and requires comprehensive alignment of a broad screening strategy with a clinical research enterprise that can use these data to accelerate development of new treatments. Here, we describe the genomic screening approach at Memorial Sloan Kettering Cancer Center, a hybridization capture-based next-generation sequencing clinical assay for solid tumor molecular oncology designated MSK-IMPACT, and how it enables and supports a large clinical trial portfolio enriched for multi-histology, biomarker-selected, ‘basket’ studies of targeted therapies. PMID:26320725

  19. Chinese herbal medicine for Mild Cognitive Impairment and Age Associated Memory Impairment: a review of randomised controlled trials.

    PubMed

    May, Brian H; Yang, Angela W H; Zhang, Anthony L; Owens, Michael D; Bennett, Louise; Head, Richard; Cobiac, Lynne; Li, Chun Guang; Hugel, Helmut; Story, David F; Xue, Charlie C L

    2009-04-01

    This review assesses the effectiveness and safety of Chinese herbal medicines (CHM) for Mild Cognitive Impairment (MCI) and Age Associated Memory Impairment (AAMI). Electronic searches of English and Chinese databases and hand searches of Chinese journal holdings were conducted. Randomised controlled trials comparing orally administered CHM with placebo, no intervention or other therapy were considered. Ginkgo biloba was excluded. Ten trials met inclusion criteria. Eight different CHM were investigated. Methodological quality was assessed using the Jadad scale and five studies scored three or above. Two studies compared CHM with placebo and eight with another intervention. This review found an overall benefit on some outcome measures for the eight CHMs involved in the 10 RCTs but methodological and data reporting issues were evident. Meta-analysis of three studies found the effects of the CHMs were at least equivalent to piracetam on Mini-Mental State Examination (MMSE) scores. No severe adverse events were reported.

  20. [Decree on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use].

    PubMed

    Schwerdtfeger, W K

    2005-02-01

    In Germany, Directive 2001/20/EC is implemented by articles 40 to 42a of the Federal Drug Act and by the Decree on Good Clinical Practice. Pivotal provisions have been included into the Federal Drug Act, such as those aiming at the clinical trial subject's protection and defining responsibilities for the evaluation of applications as well as for pharmacovigilance and surveillance. The Decree comprises: relevant definitions; requirements for manufacturing, importation and labelling of investigational medicinal products; the procedures to obtain the ethics committee's opinion and the authorization from the competent authority on the trial application and on amendments thereof; documentation and information tasks of the investigator, sponsor and competent authority; rules for inspection to verify compliance with good clinical and manufacturing practice. Finally, the decree lists infringements within the meaning of article 97, paragraph 2, no. 31 of the Federal Drug Act, and lays down the necessary provisions for a transitional period and the entering into force of the new provisions.

  1. Herbal medicines for the treatment of otitis media with effusion: a systematic review of randomised controlled trials

    PubMed Central

    Choi, Songie; Kim, Young-Eun; Kim, Yun Hee

    2016-01-01

    Objectives This systematic review aimed to assess the clinical evidence supporting the use of herbal medicines (HMs) for the treatment of otitis media with effusion (OME). Design Systematic review and meta-analysis. Data sources MEDLINE, EMBASE, Cochrane Library, AMED, CINAHL and three trial registries were searched up to January 2015. We also searched five Korean medical databases (KoreaMed, RISS, OASIS, DBPIA and KISS) and three Chinese databases (CNKI, Wanfang and VIP). Study eligibility criteria This study included randomised clinical trials that reported the effects of HM for OME. The primary outcome was the complete resolution of OME at 2 or 3 months post randomisation. Secondary outcomes included the partial or complete resolution at all possible time points and hearing test. Three authors independently screened the titles and abstracts, selected studies and extracted the data relating to trial quality, characteristics and results. Results A total of 2141 potentially relevant studies were identified, of which 17 randomised clinical trials met our inclusion criteria. Most were evaluated as having a high or unclear risk of bias. Tongqiao tablets, Tongqiao huoxue decoctions and Tsumura-Saireito were associated with a lower complete or partial resolution rate when compared with conventional medicines (CMs) (p=0.02, p=0.0001, and p=0.04, respectively), and similar outcomes were observed with Huanglong tonger pills, Erzhang decoctions and Shenling baizhu powder when combined with CM versus CM alone (p<0.00001, p=0.02, and p=0.05, respectively). Tongqiao huoxue decoction plus CM appeared to be more effective than CM in terms of improving the pure tone threshold levels (p=0.0007). Tsumura-Saireito was found to affect the proportion of patients with normalised tympanometry (p=0.03). Conclusions Despite some indications of potential symptom improvement, the evidence regarding the effectiveness and efficacy of HMs for OME is of poor quality and therefore inconclusive

  2. Chinese medicine combined with calcipotriol betamethasone and calcipotriol ointment for Psoriasis vulgaris (CMCBCOP): study protocol for a randomized controlled trial.

    PubMed

    Wen, Ze-Huai; Xuan, Mei-Ling; Yan, Yu-Hong; Li, Xiao-Yan; Yao, Dan-Ni; Li, Geng; Guo, Xin-Feng; Ou, Ai-Hua; Lu, Chuan-Jian

    2014-07-22

    Psoriasis causes worldwide concern because of its high-prevalence, as well as its harmful, and incurable characteristics. Topical therapy is a conventional treatment for psoriasis vulgaris. Chinese medicine (CM) has been commonly used in an integrative way for psoriasis patients for many years. Some CM therapies have shown therapeutic effects for psoriasis vulgaris (PV), including relieving symptoms and improving quality of life, and may reduce the relapse rate. However, explicit evidence has not yet been obtained. The purpose of the present trial is to examine the efficacy and safety of the YXBCM01 granule, a compound Chinese herbal medicine, with a combination of topical therapy for PV patients. Using an add-on design, the trial is to evaluate whether the YXBCM01 granule combined topical therapy is more effective than topical therapy alone for the treatment of PV. The study design is a double-blind, parallel, randomized controlled trial comparing the YXBCM01 granule (5.5 g twice daily) to a placebo. The duration of treatment is 12 weeks. A total of 600 participants will be randomly allocated into two groups, YXBCM01 granule group and placebo group, from 11 general or dermatological hospitals in China. Topical use of calcipotriol betamethasone for the first 4 weeks and calcipotriol ointment for the remaining 8 weeks will be the same standard therapy for the two groups. Patients will be enrolled if they have a clinical diagnosis of PV, a psoriasis area severe index (PASI) of more than 10 or body surface area (BSA) of more than 10%, but PASI of less than 30 and BSA of less than 30%, are aged between 18 and 65-years-old, and provide signed informed consent. The primary outcome, relapse rate, is based on PASI assessed blindly during the treatment. Secondary outcomes include: (i) relapse time interval, (ii) time to onset, (iii) rebound rate, (iv) PASI score, (v) cumulative consumption of medicine, (vi) the dermatology quality life index (DLQI), and (vii) the

  3. Venture Class Launch Services

    NASA Technical Reports Server (NTRS)

    Wiese, Mark

    2016-01-01

    Provide an introduction to the Launch Services Program, and specifically the strategic initiative that drove the Venture Class Launch Services contracts. Provide information from the VCLS request for proposals, as well as the Agency's CubeSat Launch Initiative.

  4. Launch summary for 1978

    NASA Technical Reports Server (NTRS)

    Vostreys, R. W.

    1978-01-01

    Sounding rocket, satellite, and space probe launchings are presented. Time, date, and location of the launches are provided. The sponsoring countries and the institutions responsible for the launch are listed.

  5. Chinese patent medicines for the treatment of the common cold: a systematic review of randomized clinical trials.

    PubMed

    Chen, Wei; Liu, Bo; Wang, Li-qiong; Ren, Jun; Liu, Jian-ping

    2014-07-30

    Many Chinese patent medicines (CPMs) have been authorized by the Chinese State of Food and Drug Administration for the treatment of the common cold. A number of clinical trials have been conducted and published. However, there is no systematic review or meta-analysis on their efficacy and safety for the common cold to justify their clinical use. We searched CENTRAL, MEDLINE, EMBASE, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites for published and unpublished randomized clinical trials (RCTs) of CPMs for the common cold till 31 March 2013. Revman 5.2 software was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI). A total of five RCTs were identified. All of the RCTs were of high risk of bias with flawed study design and poor methodological quality. All RCTs included children aged between 6 months to 14 years. Results of individual trials showed that Shuanghuanglian oral liquid (RR 4.00; 95% CI: 2.26 to 7.08), and Xiaoer Resuqing oral liquid (RR 1.43; 95% CI: 1.15 to 1.77) had higher cure rates compared with antivirus drugs. Most of the trials did not report adverse events, and the safety of CPMs was still uncertain. Some CPMs showed a potential positive effect for the common cold on cure rate. However, due to the poor methodology quality and the defects in the clinical design of the included RCTs, such as the lack of placebo controlled trials, the inappropriate comparison intervention and outcome measurement, the confirmative conclusions on the beneficial effect of CPMs for the common cold could not be drawn.

  6. Modern clinical research: How rapid learning health care and cohort multiple randomised clinical trials complement traditional evidence based medicine.

    PubMed

    Lambin, Philippe; Zindler, Jaap; Vanneste, Ben; van de Voorde, Lien; Jacobs, Maria; Eekers, Daniëlle; Peerlings, Jurgen; Reymen, Bart; Larue, Ruben T H M; Deist, Timo M; de Jong, Evelyn E C; Even, Aniek J G; Berlanga, Adriana J; Roelofs, Erik; Cheng, Qing; Carvalho, Sara; Leijenaar, Ralph T H; Zegers, Catharina M L; van Limbergen, Evert; Berbee, Maaike; van Elmpt, Wouter; Oberije, Cary; Houben, Ruud; Dekker, Andre; Boersma, Liesbeth; Verhaegen, Frank; Bosmans, Geert; Hoebers, Frank; Smits, Kim; Walsh, Sean

    2015-01-01

    Trials are vital in informing routine clinical care; however, current designs have major deficiencies. An overview of the various challenges that face modern clinical research and the methods that can be exploited to solve these challenges, in the context of personalised cancer treatment in the 21st century is provided. The purpose of this manuscript, without intending to be comprehensive, is to spark thought whilst presenting and discussing two important and complementary alternatives to traditional evidence-based medicine, specifically rapid learning health care and cohort multiple randomised controlled trial design. Rapid learning health care is an approach that proposes to extract and apply knowledge from routine clinical care data rather than exclusively depending on clinical trial evidence, (please watch the animation: http://youtu.be/ZDJFOxpwqEA). The cohort multiple randomised controlled trial design is a pragmatic method which has been proposed to help overcome the weaknesses of conventional randomised trials, taking advantage of the standardised follow-up approaches more and more used in routine patient care. This approach is particularly useful when the new intervention is a priori attractive for the patient (i.e. proton therapy, patient decision aids or expensive medications), when the outcomes are easily collected, and when there is no need of a placebo arm. Truly personalised cancer treatment is the goal in modern radiotherapy. However, personalised cancer treatment is also an immense challenge. The vast variety of both cancer patients and treatment options makes it extremely difficult to determine which decisions are optimal for the individual patient. Nevertheless, rapid learning health care and cohort multiple randomised controlled trial design are two approaches (among others) that can help meet this challenge.

  7. Clinical trial methodology and clinical cohorts: the importance of complete follow-up in trials evaluating the virological efficacy of anti-HIV medicines.

    PubMed

    Kirk, Ole; Lundgren, Jens D

    2004-02-01

    It has been common practice in randomized trials of HIV medicines to classify switches away from the original therapy as failures in analyses of virological effect, in line with an HIV-RNA measurement above a given level of quantification. This approach precludes the ability to identify the possible effects of a given therapy on those of a subsequent therapy. This review explores whether there have been changes in the reporting of randomized trials since the importance of continuous follow-up throughout the study period was initially raised 2 years ago. Follow-up is still likely to be discontinued at a premature switch from study medication in a large number of the randomized trials published in 2002-2003. However, some studies, all initiated by investigators, did follow patients throughout the study period. In three of the studies, the proportions of patients with virological failure assessed with and without data after the premature discontinuation of randomized therapy could be elicited. Substantial differences were seen in the comparisons of two highly active antiretroviral therapy regimens according to the choice of analytical approach. In all three studies significant differences were observed between the regimens according to one approach, but not to the other. The notation of treatment switch equals failure leads to an imprecise measurement of virological effect, and complete follow-up throughout the study period should be strongly encouraged, thus enabling several supplementary analyses of the virological effect of the treatment strategies being compared.

  8. Lab Plays Central Role in Groundbreaking National Clinical Trial in Precision Medicine | FNLCR

    Cancer.gov

    The Molecular Characterization Laboratory at the Frederick National Laboratory for Cancer Research lies at the heart of an ambitious new approach for testing cancer drugs that will use the newest tools of precision medicine to select the best treatme

  9. Lab Plays Central Role in Groundbreaking National Clinical Trial in Precision Medicine | FNLCR Staging

    Cancer.gov

    The Molecular Characterization Laboratory at the Frederick National Laboratory for Cancer Research lies at the heart of an ambitious new approach for testing cancer drugs that will use the newest tools of precision medicine to select the best treatme

  10. Randomized trial of epidural injections for spinal stenosis published in the New England Journal of Medicine: further confusion without clarification.

    PubMed

    Manchikanti, Laxmaiah; Candido, Kenneth D; Kaye, Alan D; Boswell, Mark V; Benyamin, Ramsin M; Falco, Frank J E; Gharibo, Christopher G; Hirsch, Joshua A

    2014-01-01

    Randomized controlled trials are considered the hallmark of evidence-based medicine. This conveys the idea that up-to-date evidence applied consistently in clinical practice, in combination with clinicians' individual expertise and patients own preference/expectations are enjoined to achieve the best possible outcome. Since its inception in 1990s, evidence-based medicine has evolved in conjunction with numerous changes in the healthcare environment. However, the benefits of evidence-based medicine have not materialized for spinal pain including surgical interventions. Consequently, the debate continues on the efficacy and medical necessity of multiple interventions provided in managing spinal pain. Friedly et al published a randomized controlled trial of epidural glucocorticoid injections for spinal stenosis in the July 2014 edition of the highly prestigious New England Journal of Medicine. This was accompanied by an editorial from Andersson. This manuscript provided significant sensationalism for the media and confusion for the spine community. This randomized trial of epidural glucocorticoid injections for spinal stenosis and accompanying editorial concluded that epidural injections of glucocorticoids plus lidocaine offered minimal or no short-term benefit as compared with epidural injections of lidocaine alone, with the editorial emphasizing proceeding directly to surgical intervention. In addition media statements by the authors also emphasized the idea that exercise or surgery might be better options for patients suffereing from narrowing of the spinal canal. The interventional pain management community believes that there are severe limitations to this study, manuscript, and accompanying editorial. The design, inclusion criteria, outcomes assessment, analysis of data and interpretation, and conclusions of this trial point to the fact that this highly sophisticated and much publicized randomized trial may not be appropriate and lead to misinformation. The

  11. Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency.

    PubMed

    Elsäßer, Amelie; Regnstrom, Jan; Vetter, Thorsten; Koenig, Franz; Hemmings, Robert James; Greco, Martina; Papaluca-Amati, Marisa; Posch, Martin

    2014-10-02

    Since the first methodological publications on adaptive study design approaches in the 1990s, the application of these approaches in drug development has raised increasing interest among academia, industry and regulators. The European Medicines Agency (EMA) as well as the Food and Drug Administration (FDA) have published guidance documents addressing the potentials and limitations of adaptive designs in the regulatory context. Since there is limited experience in the implementation and interpretation of adaptive clinical trials, early interaction with regulators is recommended. The EMA offers such interactions through scientific advice and protocol assistance procedures. We performed a text search of scientific advice letters issued between 1 January 2007 and 8 May 2012 that contained relevant key terms. Letters containing questions related to adaptive clinical trials in phases II or III were selected for further analysis. From the selected letters, important characteristics of the proposed design and its context in the drug development program, as well as the responses of the Committee for Human Medicinal Products (CHMP)/Scientific Advice Working Party (SAWP), were extracted and categorized. For 41 more recent procedures (1 January 2009 to 8 May 2012), additional details of the trial design and the CHMP/SAWP responses were assessed. In addition, case studies are presented as examples. Over a range of 5½ years, 59 scientific advices were identified that address adaptive study designs in phase II and phase III clinical trials. Almost all were proposed as confirmatory phase III or phase II/III studies. The most frequently proposed adaptation was sample size reassessment, followed by dropping of treatment arms and population enrichment. While 12 (20%) of the 59 proposals for an adaptive clinical trial were not accepted, the great majority of proposals were accepted (15, 25%) or conditionally accepted (32, 54%). In the more recent 41 procedures, the most frequent

  12. New Product Launching Ideas

    NASA Astrophysics Data System (ADS)

    Kiruthika, E.

    2012-09-01

    Launching a new product can be a tense time for a small or large business. There are those moments when you wonder if all of the work done to develop the product will pay off in revenue, but there are many things are can do to help increase the likelihood of a successful product launch. An open-minded consumer-oriented approach is imperative in todayís diverse global marketplace so a firm can identify and serve its target market, minimize dissatisfaction, and stay ahead of competitors. Final consumers purchase for personal, family, or household use. Finally, the kind of information that the marketing team needs to provide customers in different buying situations. In high-involvement decisions, the marketer needs to provide a good deal of information about the positive consequences of buying. The sales force may need to stress the important attributes of the product, the advantages compared with the competition; and maybe even encourage ìtrialî or ìsamplingî of the product in the hope of securing the sale. The final stage is the post-purchase evaluation of the decision. It is common for customers to experience concerns after making a purchase decision. This arises from a concept that is known as ìcognitive dissonance

  13. Clinical trials of medicinal cannabis for appetite-related symptoms from advanced cancer: a survey of preferences, attitudes and beliefs among patients willing to consider participation.

    PubMed

    Luckett, T; Phillips, J; Lintzeris, N; Allsop, D; Lee, J; Solowij, N; Martin, J; Lam, L; Aggarwal, R; McCaffrey, N; Currow, D; Chye, R; Lovell, M; McGregor, I; Agar, M

    2016-11-01

    Australian clinical trials are planned to evaluate medicinal cannabis in a range of clinical contexts. To explore the preferences, attitudes and beliefs of patients eligible and willing to consider participation in a clinical trial of medicinal cannabis for poor appetite and appetite-related symptoms from advanced cancer. A cross-sectional anonymous survey was administered from July to December 2015 online and in eight adult outpatient palliative care and/or cancer services. Respondents were eligible if they were ≥18 years, had advanced cancer and poor appetite/taste problems/weight loss and might consider participating in a medicinal cannabis trial. Survey items focused on medicinal rather than recreational cannabis use and did not specify botanical or pharmaceutical products. Items asked about previous medicinal cannabis use and preferences for delivery route and invited comments and concerns. There were 204 survey respondents, of whom 26 (13%) reported prior medicinal cannabis use. Tablets/capsules were the preferred delivery mode (n = 144, 71%), followed by mouth spray (n = 84, 42%) and vaporiser (n = 83, 41%). Explanations for preferences (n = 134) most commonly cited convenience (n = 66; 49%). A total of 82% (n = 168) of respondents indicated that they had no trial-related concerns, but a small number volunteered concerns about adverse effects (n = 14) or wanted more information/advice (n = 8). Six respondents volunteered a belief that cannabis might cure cancer, while two wanted assurance of efficacy before participating in a trial. Justification of modes other than tablets/capsules and variable understanding about cannabis and trials will need addressing in trial-related information to optimise recruitment and ensure that consent is properly informed. © 2016 Royal Australasian College of Physicians.

  14. Why do – or don’t – patients with urinary tract infection participate in a clinical trial? A qualitative study in German family medicine

    PubMed Central

    Bleidorn, Jutta; Bucak, Sermin; Gágyor, Ildikó; Hummers-Pradier, Eva; Dierks, Marie-Luise

    2015-01-01

    family medicine, the following key issues should be considered: emphasizing patients’ personal benefit, featuring patient relevant trial topics, providing a maximum of safety, keeping effort by trial procedures comfortable. PMID:26512232

  15. Medicine and Human Rights: Reflections on the Fiftieth Anniversary of the Doctors' Trial.

    PubMed

    Annas; Grodin

    1996-01-01

    1996 marks the fiftieth anniversary of the commencement of the trial of Nazi physicians at Nuremberg, a trial that has been variously designated as the "Doctors' Trial" and the "Medical Case." In addition to documenting atrocities committed by physicians and scientists during WWII, the most significant contribution of the trial has come to be known as the "Nuremberg Code," a judicial codification of 10 prerequisites for the moral and legal use of human beings in experiments. Anniversaries provide us with an opportunity to reflect upon the past, but they also enable us to renew our efforts to plan for the future. This article describes briefly the historical evolution of the Nuremberg Code, discusses its current relevance and applicability by using a case study example, and proposes future steps to be taken by the international community.

  16. Decision making in family medicine: randomized trial of the effects of the InfoClinique and Trip database search engines.

    PubMed

    Labrecque, Michel; Ratté, Stéphane; Frémont, Pierre; Cauchon, Michel; Ouellet, Jérôme; Hogg, William; McGowan, Jessie; Gagnon, Marie-Pierre; Njoya, Merlin; Légaré, France

    2013-10-01

    To compare the ability of users of 2 medical search engines, InfoClinique and the Trip database, to provide correct answers to clinical questions and to explore the perceived effects of the tools on the clinical decision-making process. Randomized trial. Three family medicine units of the family medicine program of the Faculty of Medicine at Laval University in Quebec city, Que. Fifteen second-year family medicine residents. Residents generated 30 structured questions about therapy or preventive treatment (2 questions per resident) based on clinical encounters. Using an Internet platform designed for the trial, each resident answered 20 of these questions (their own 2, plus 18 of the questions formulated by other residents, selected randomly) before and after searching for information with 1 of the 2 search engines. For each question, 5 residents were randomly assigned to begin their search with InfoClinique and 5 with the Trip database. The ability of residents to provide correct answers to clinical questions using the search engines, as determined by third-party evaluation. After answering each question, participants completed a questionnaire to assess their perception of the engine's effect on the decision-making process in clinical practice. Of 300 possible pairs of answers (1 answer before and 1 after the initial search), 254 (85%) were produced by 14 residents. Of these, 132 (52%) and 122 (48%) pairs of answers concerned questions that had been assigned an initial search with InfoClinique and the Trip database, respectively. Both engines produced an important and similar absolute increase in the proportion of correct answers after searching (26% to 62% for InfoClinique, for an increase of 36%; 24% to 63% for the Trip database, for an increase of 39%; P = .68). For all 30 clinical questions, at least 1 resident produced the correct answer after searching with either search engine. The mean (SD) time of the initial search for each question was 23.5 (7

  17. Combined Lifestyle and Herbal Medicine in Overweight Women with Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial.

    PubMed

    Arentz, Susan; Smith, Caroline A; Abbott, Jason; Fahey, Paul; Cheema, Birinder S; Bensoussan, Alan

    2017-09-01

    Polycystic ovary syndrome (PCOS) is a common, complex reproductive endocrinopathy characterized by menstrual irregularities, hyperandrogenism and polycystic ovaries. Lifestyle modification is a first-line intervention; however, there are barriers to success for this form of self-care, and women often seek adjunct therapies including herbal medicines. This pragmatic, randomized controlled trial, delivered in communities of Australia in overweight women with PCOS, compared the effectiveness and safety of a lifestyle intervention plus herbal medicine against lifestyle alone. All participants were helped to construct a personalized lifestyle plan. The herbal intervention consisted of two tablets. Tablet 1 contained Cinnamomum verum, Glycyrrhiza glabra, Hypericum perforatum and Paeonia lactiflora. Tablet 2 contained Tribulus terrestris. The primary outcome was oligomenorrhoea/amenorrhoea. Secondary outcomes were hormones; anthropometry; quality of life; depression, anxiety and stress; pregnancy; birth outcomes; and safety. One hundred and twenty-two women gave their consent. At 3 months, women in the combination group recorded a reduction in oligomenorrhoea of 32.9% (95% confidence interval 23.3-42.6, p < 0.01) compared with controls, estimated as a large effect (ηp(2)  = 0.11). Other significant improvements were found for body mass index (p < 0.01); insulin (p = 0.02) and luteinizing hormone (p = 0.04); blood pressure (p = 0.01); quality of life (p < 0.01); depression, anxiety and stress (p < 0.01); and pregnancy rates (p = 0.01). This trial provides evidence of improved effectiveness and safety for lifestyle intervention when combined with herbal medicines in women with PCOS. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd.

  18. Combined Lifestyle and Herbal Medicine in Overweight Women with Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial

    PubMed Central

    Smith, Caroline A.; Abbott, Jason; Fahey, Paul; Cheema, Birinder S.; Bensoussan, Alan

    2017-01-01

    Polycystic ovary syndrome (PCOS) is a common, complex reproductive endocrinopathy characterized by menstrual irregularities, hyperandrogenism and polycystic ovaries. Lifestyle modification is a first‐line intervention; however, there are barriers to success for this form of self‐care, and women often seek adjunct therapies including herbal medicines. This pragmatic, randomized controlled trial, delivered in communities of Australia in overweight women with PCOS, compared the effectiveness and safety of a lifestyle intervention plus herbal medicine against lifestyle alone. All participants were helped to construct a personalized lifestyle plan. The herbal intervention consisted of two tablets. Tablet 1 contained Cinnamomum verum, Glycyrrhiza glabra, Hypericum perforatum and Paeonia lactiflora. Tablet 2 contained Tribulus terrestris. The primary outcome was oligomenorrhoea/amenorrhoea. Secondary outcomes were hormones; anthropometry; quality of life; depression, anxiety and stress; pregnancy; birth outcomes; and safety. One hundred and twenty‐two women gave their consent. At 3 months, women in the combination group recorded a reduction in oligomenorrhoea of 32.9% (95% confidence interval 23.3–42.6, p < 0.01) compared with controls, estimated as a large effect (ηp 2 = 0.11). Other significant improvements were found for body mass index (p < 0.01); insulin (p = 0.02) and luteinizing hormone (p = 0.04); blood pressure (p = 0.01); quality of life (p < 0.01); depression, anxiety and stress (p < 0.01); and pregnancy rates (p = 0.01). This trial provides evidence of improved effectiveness and safety for lifestyle intervention when combined with herbal medicines in women with PCOS. © 2017 The Authors. Phytotherapy Research published by John Wiley & Sons Ltd PMID:28685911

  19. Learning about Activity and Understanding Nutrition for Child Health (LAUNCH): Rationale, design, and implementation of a randomized clinical trial of a family-based pediatric weight management program for preschoolers.

    PubMed

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

    2017-01-01

    Obesity affects nearly 2 million preschool age children in the United States and is not abating. However, research on interventions for already obese preschoolers is limited. To address this significant gap in the literature, we developed an intervention targeting obesity reduction in 2 to 5year olds, Learning about Activity and Understanding Nutrition for Child Health (LAUNCH). This paper describes the rationale, design, participant enrollment, and implementation of a 3-arm randomized, parallel-group clinical trial comparing LAUNCH to a motivational-interviewing intervention (MI) and standard care (STC), respectively. Whereas LAUNCH was designed as a skills based intervention, MI focused on addressing the guardian's motivation to make changes in diet and activity and providing tools to do so at the guardian's level of readiness to implement changes. Child body mass index z-score was the primary outcome, assessed at pretreatment, posttreatment (Month 6), and 6 and 12month follow-ups (Months 12 and 18). Mechanisms of weight change (e.g., dietary intake, physical activity) and environmental factors associated with weight (e.g., foods available in the home, caregiver diet) were also assessed. This study is unique because it is one of the few randomized controlled trials to examine a developmentally informed, clinic and home skills based behavioral family intervention for preschoolers who are already obese. Being obese during the preschool years increases the likelihood of remaining obese as an adult and is associated with serious health conditions; if this intervention is successful, it has the potential to change the health trajectories for young children with obesity.

  20. JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial

    PubMed Central

    2010-01-01

    Background Pre-diabetes is a growing health concern where a large percentage of these patients develop full type 2 diabetes. Effective interventions on pre-diabetes can prevent or delay the occurrence or development of diabetes. Pharmaco-dynamics and pre-clinical of JinQi-Jiangtang tablets (JQJT) suggest that it could be benefit for pre-diabetes. Methods/Design Randomized controlled trial (RCT) is implemented in this study. The study term is 24 months (12 months for intervention and 12 months for follow up). Participants are recruited from four cities of China: Beijing, Tianjin, Xi'an and Nanning. Four hundred participants are randomized to treatment group (JQJT tablets) and control group (Placebo); two hundred participants each. People being included in this study must have been diagnosed as pre-diabetes via western medicine criteria and traditional Chinese medicine (TCM) criteria. The end-point indexes include: incidence of diabetes mellitus and reversion rate. Primary outcome indexes include: oral glucose tolerance test; insulin releasing test; glycosylated hemoglobin (HA1c). Secondary outcome indexes include: score of the Short Form 36 Health Survey Questionnaire (SF-36); score of TCM symptoms; blood lipid test. Indexes of safety include: general medical examination; blood and urine regular test; electrocardiogram (ECG), liver function (ALT) and renal function (BUN, Creatinine) test; record of adverse event, such as headache, faint, etc. Qualitative control will be implemented and a number of standard operating processes (SOPs) will be formed throughout the study: laboratory quality control measures; compliance control for researchers and participants; researcher training before study; supervision; investigational drug management and others. Discussion The aim of this study is to evaluate the effectiveness and safety of JinQi JiangTang (JQJT) tablets for the treatment of patients with pre-diabetes. Trial registration Chinese clinical trials register Chi

  1. STS-120 launch

    NASA Image and Video Library

    2007-10-23

    STS120-S-026 (23 Oct. 2007) --- In the firing room of the Kennedy Space Center in Florida, NASA Shuttle Launch Director Michael Leinbach (second right) and launch managers watch the 11:38 a.m. (EDT) launch of Space Shuttle Discovery. Discovery launched Oct. 23 on a 14-day construction mission to the International Space Station. Photo credit: NASA/Bill Ingalls

  2. Individually integrated traditional chinese medicine approach in the management of knee osteoarthritis: study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background Knee osteoarthritis (OA) is considered a major public health issue causing chronic disability worldwide with the increasing number of aging people. In China and increasingly worldwide, many sufferers with knee OA are using complementary and alternative medicine including herbal drug, herbal patch, acupuncture and Tuina etc., to alleviate their symptoms. However, evidence gathered from systematic reviews or randomized controlled trials (RCT) has only validated acupuncture for the management of osteoarthritic pain. Moreover, such Traditional Chinese Medicine (TCM) methods above are commonly used in an integrative way. This trial is aimed to compare the efficacy of an individually integrated TCM approach in the management of knee OA with other single treatments as parallel randomized controls. Methods/design Five teaching hospitals will participate in this randomized controlled trial. 500 participants, 100 in each hospital, will be randomly assigned to receive oral administration of a Chinese herbal drug (counter osteophytes capsule), topical use of a Chinese herbal patch (Fufnag Zijin patch), acupuncture, Tuina and the individually integrated TCM approach. The individually integrated TCM approach consists of basic treatment of oral counter osteophytes capsule, variable use of Tuina, acupuncture and a herbal patch based on the severity of the patient's symptoms. The interventions are given for a period of 4 weeks. The primary outcome measure is the self-reported total score using the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcome measures include patient and investigator global assessment of response to treatment, patient and investigator global assessment of OA condition, WOMAC pain, stiffness, and physical function subscales, short-form 36 (SF-36) and TCM assessment of OA condition measured by syndromes questionnaire. Mixed models and sensitivity analysis will be used for the statistical analysis. Discussion The

  3. Effect of oriental medicine music therapy on patients with Hwa-byung: a study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Hwa-byung, a Korean culture-bound syndrome with both psychological and somatic symptoms, is also known as ‘anger syndrome’. It includes various physical symptoms including anxiety, a feeling of overheating, a sensation of pressure on the chest, heart palpitations, respiratory stuffiness, insomnia, and anxiety. Methods/design The proposed study is a single-center, double-blind, randomized, controlled trial with two parallel arms: an oriental medicine music therapy (OMMT) group and a control music therapy (CMT) group. In total, 48 patients will be enrolled into the trial. The first visit will be the screening visit. At baseline (visit 2), all participants fulfilling both the inclusion and the exclusion criteria will be split and randomly divided into two equal groups: the OMMT and the CMT (n = 24 each). Each group will receive treatment sessions over the course of 4 weeks, twice per week, for eight sessions in total. The primary outcome is the State-Trait Anxiety Inventory (STAI), and the secondary outcomes are the Hwa-byung scale (H-scale), the Center for Epidemiologic Studies Depression Scale (CES-D), the Hwa-byung visual analogue scale (H-VAS) for primary symptoms, the World Health Organization Quality of Life scale, brief version (WHOQOL-BREF), and levels of salivary cortisol. Patients will be asked to complete questionnaires at the baseline visit (visit 2), after the last treatment session (visit 9), and at 4 weeks after the end of all trial sessions (visit 10). From the baseline (visit 2) through the follow-up (visit 10), the entire process will take a total of 53 days. Discussion This proposed study targets patients with Hwa-byung, especially those who have exhibited symptoms of anxiety. Therefore, the primary outcome is set to measure the level of anxiety. OMMT is music therapy combined with traditional Korean medicinal theories. Unlike previously reported music therapies, for which patients simply listen to music passively, in OMMT, patients

  4. Herbal medicine (Gyejibongneyong-hwan) for treating primary dysmenorrhoea: a protocol for a systematic review of randomised controlled trials

    PubMed Central

    Lee, Ju Ah; Park, Sunju; Jung, Jeeyoun; Jun, Ji Hee; Choi, Jiae

    2016-01-01

    Introduction Gyejibongneyong-hwan (GBH), also known as Guizhi Fuling formula, and is widely used for uterine fibroids in East Asian countries. Many clinical trials assessing the efficacy and safety of GBH formula for the treatment of dysmenorrhoea have been reported. This review will assess the clinical evidence for and against the use of GBH formula as a treatment for dysmenorrhoea. It will also discuss the proposed mechanism(s) that could link herbal medicine to improvements in dysmenorrhoea. Methods and analysis Fourteen databases will be searched until September 2016. We will include randomised controlled trials (RCTs) examining GBH decoctions for any type of dysmenorrhoea. All RCTs of decoctions or modified decoctions will be included. The methodological qualities of the RCTs will be assessed using the Cochrane Collaboration tool for assessing risk of bias. Ethics and dissemination This systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically and in print. It will be updated to inform and guide healthcare practices. Trial registration number CRD42015023419. PMID:27683510

  5. Safety and Toxicity of Saw palmetto in the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Trial

    PubMed Central

    Avins, Andrew L.; Lee, Jeannette Y.; Meyers, Catherine M.; Barry, Michael J.

    2013-01-01

    Purpose Extracts of the saw palmetto berry are used by many men in the U.S. as self-treatment for lower urinary tract symptoms due to benign prostatic hyperplasia. While the most recent data from double-blind clinical trials do not support efficacy superior to that of placebo, there are few data on the toxicity of saw palmetto. Materials and Methods 369 patients were randomized in the Complementary and Alternative Medicine for Urological Symptoms (CAMUS) trial; 357 participants are included in this modified intention-to-treat analysis. Participants were randomized to 320mg, 640mg, and 960mg daily of an ethanolic saw palmetto extract or an identical-appearing placebo, in an escalating manner at 6-month intervals, for a total of 18 months follow-up. Adverse-event assessments, vital signs, and blood and urine laboratory tests were obtained at regular intervals. Results There were no statistically significant differences between groups in rates of serious or non-serious adverse events, changes in vital signs, digital prostate exam findings, or study withdrawal rates. Overall, there were no significant inter-group differences in the occurrence of laboratory-test abnormalities; differences in individual laboratory tests were uncommon and small in magnitude. No evidence of significant dose-response phenomena were identified. Conclusions The saw palmetto extract used in the CAMUS trial showed no evidence of toxicity at doses up to three times the usual clinical dose over a period of 18 months. PMID:23063633

  6. Impact of a bedside procedure service on general medicine inpatients: A firm-based trial.

    PubMed

    Lucas, Brian P; Asbury, Joseph K; Wang, Yue; Lee, Kuenok; Kumapley, Rudolf; Mba, Benjamin; Borkowsky, Shane; Asmar, Abdo

    2007-05-01

    Procedure services may improve the training of bedside procedures. However, little is known about how procedure services may affect the demand for and success of procedures performed on general medicine inpatients. Determine whether a procedure service affects the number and success of 4 bedside procedures (paracentesis, thoracentesis, lumbar puncture, and central venous catheterization) attempted on general medicine inpatients. Prospective cohort study. Large public teaching hospital. Nineteen hundred and forty-one consecutive admissions to the general medicine service. A bedside procedure service was offered to physicians from 1 of 3 firms for 4 weeks. This service then crossed over to physicians from the other 2 firms for another 4 weeks. Data on all procedure attempts were collected daily from physicians. We examined whether the number of attempts and the proportion of successful attempts differed based on whether firms were offered the beside procedure service. The number of procedure attempts was 48% higher in firms offered the service (90 versus 61 per 1000 admissions; RR 1.48, 95% CI 1.06-2.10; P = .030). More than 85% of the observed increase was a result of procedures with therapeutic indications. There were no differences between firms in the proportions of successful attempts or major complications. The availability of a procedure service may increase the overall demand for bedside procedures. Further studies should refine the indications for and anticipated benefits from these commonly performed invasive procedures. (c) 2007 Society of Hospital Medicine.

  7. Oral granulated Chinese herbal medicine (YXBCM01) plus topical calcipotriol for psoriasis vulgaris: study protocol for a double-blind, randomized placebo controlled trial.

    PubMed

    Parker, Shefton; Zhang, Anthony Lin; Zhang, Claire Shuiqing; Goodman, Greg; Wen, Zehuai; Lu, Chuanjian; Xue, Charlie Changlie

    2014-12-19

    Probably related to immune dysfunction, psoriasis vulgaris is a chronic, painful, disfiguring and disabling dermatological disease, carrying an increased risk of serious comorbidities. Current conventional therapies can be costly, show risks of side effects and have limited efficacy, with relapse common on treatment cessation. Chinese herbal medicine is effective in treating psoriasis vulgaris. However, any benefit of adding Chinese herbal medicine to conventional treatments when treating psoriasis vulgaris is yet to be determined. This is a pilot randomized, placebo controlled, double-blinded trial. The pilot is primarily to determine the feasibility of undertaking a full size randomized trial. Thirty participants with psoriasis vulgaris and Psoriasis Area Severity Index (PASI) scores ≥ 7 and ≤ 12 will be included. Participants will be randomized (in a 1:1 ratio) to receive oral granulated Chinese herbal medicine YXBCM01 plus topical calcipotriol 0.005% or oral YXBCM01 placebo plus topical calcipotriol 0.005% treatment for 12 weeks, with a 12-week follow-up phase. The Chinese herbal medicine or placebo will be administered orally as dissolvable granules. The primary outcome measure will be PASI change (%) from baseline to the end of treatment phase. Secondary outcomes will include safety, key psoriasis-related cytokine changes (for example, IL12, IL17 and IL 23) during the entire trial and symptom relapse rates at the end of the follow-up phase. The study will evaluate the feasibility of a randomized controlled trial investigating combined conventional and Chinese herbal medicine therapy for psoriasis vulgaris. The ingredients of YXBCM01 were selected based on literature, the expert opinion on herbal medicine and pre-clinical evidence, for instance Chinese herbal medicine possesses anti-inflammatory or antiproliferative properties. Australian New Zealand Clinical Trials Registry ACTRN12614000493640.

  8. Compound Formulas of Traditional Chinese Medicine for the Common Cold: Systematic Review of Randomized, Placebo-controlled Trials.

    PubMed

    Li, Guanhong; Cai, Linli; Jiang, Hongli; Dong, Shoujin; Fan, Tao; Liu, Wei; Xie, Li; Mao, Bing

    2015-01-01

    The common cold is one of the most frequent acute illnesses of the respiratory tract, affecting all age groups. The compound formulas of traditional Chinese medicine (TCM) are frequently used to treat the common cold in China and other parts of the world. Until now, however, the efficacy and safety of compound formulas of TCM for the common cold, studied in comparison with placebos, have not been systematically reviewed. This literature review intended to assess existing evidence of the effectiveness and safety of compound formulas of TCM for the common cold. Randomized, controlled trials (RCTs) comparing compound formulas of TCM with placebos in treating the common cold were included, regardless of publication status. The research team searched the Cochrane Library, PubMed, Embase, the Chinese Biomedical Literature Database, the Chinese Scientific and Technological Periodical Database, the Chinese National Knowledge Infrastructure and the Wangfang Database from their inceptions to December 2013. The team also searched Web sites listing ongoing trials and contacted experts in the field and relevant pharmaceutical companies to locate unpublished materials. Two review authors independently extracted data and assessed the methodological quality of included studies, using the Cochrane risk of bias tool. A total of 6 randomized, double-blind, placebo-controlled trials involving 1502 participants were included. Most trials had a low risk of bias. Five were conducted in mainland China and 1 in Hong Kong; 5 were multicenter clinical trials and 1 was a single-center trial; 4 were published in Chinese and 2 were published in English. Compound formulas of TCM were superior to placebos in reducing disease symptoms, inducing recovery from a TCM syndrome, and increasing quality of life. In addition, the formulas were superior in shortening the duration of the main symptoms, the amount of time for a decline in temperature of at least 0.5°C to occur, and the duration of any fever

  9. Space Shuttle Discovery Launch

    NASA Image and Video Library

    2008-05-31

    NASA Shuttle Launch Director Michael Leinbach, left, STS-124 Assistant Launch Director Ed Mango, center, and Flow Director for Space Shuttle Discovery Stephanie Stilson clap in the the Launch Control Center after the main engine cut off and successful launch of the Space Shuttle Discovery (STS-124) Saturday, May 31, 2008, at the Kennedy Space Center in Cape Canaveral, Fla. The Shuttle lifted off from launch pad 39A at 5:02 p.m. EDT. Photo Credit: (NASA/Bill Ingalls)

  10. Applying Precision Medicine to Trial Design Using Physiology. Extracorporeal CO2 Removal for Acute Respiratory Distress Syndrome.

    PubMed

    Goligher, Ewan C; Amato, Marcelo B P; Slutsky, Arthur S

    2017-09-01

    In clinical trials of therapies for acute respiratory distress syndrome (ARDS), the average treatment effect in the study population may be attenuated because individual patient responses vary widely. This inflates sample size requirements and increases the cost and difficulty of conducting successful clinical trials. One solution is to enrich the study population with patients most likely to benefit, based on predicted patient response to treatment (predictive enrichment). In this perspective, we apply the precision medicine paradigm to the emerging use of extracorporeal CO2 removal (ECCO2R) for ultraprotective ventilation in ARDS. ECCO2R enables reductions in tidal volume and driving pressure, key determinants of ventilator-induced lung injury. Using basic physiological concepts, we demonstrate that dead space and static compliance determine the effect of ECCO2R on driving pressure and mechanical power. This framework might enable prediction of individual treatment responses to ECCO2R. Enriching clinical trials by selectively enrolling patients with a significant predicted treatment response can increase treatment effect size and statistical power more efficiently than conventional enrichment strategies that restrict enrollment according to the baseline risk of death. To support this claim, we simulated the predicted effect of ECCO2R on driving pressure and mortality in a preexisting cohort of patients with ARDS. Our computations suggest that restricting enrollment to patients in whom ECCO2R allows driving pressure to be decreased by 5 cm H2O or more can reduce sample size requirement by more than 50% without increasing the total number of patients to be screened. We discuss potential implications for trial design based on this framework.

  11. Evidence of Chinese herbal medicine Duhuo Jisheng decoction for knee osteoarthritis: a systematic review of randomised clinical trials

    PubMed Central

    Zhang, Wenming; Wang, Shangquan; Zhang, Ranxing; Zhang, Yuanyuan; Li, Xinjian; Lin, Yanping; Wei, Xu

    2016-01-01

    Objectives Duhuo Jisheng decoction (DJD) is considered beneficial for controlling knee osteoarthritis (KOA)-related symptoms in some Asian countries. This review compiles the evidence from randomised clinical trials and quantifies the effects of DJD on KOA. Designs 7 online databases were investigated up to 12 October 2015. Randomised clinical trials investigating treatment of KOA for which DJD was used either as a monotherapy or in combination with conventional therapy compared to no intervention, placebo or conventional therapy, were included. The outcomes included the evaluation of functional activities, pain and adverse effect. The risk of bias was evaluated using the Cochrane Collaboration tool. The estimated mean difference (MD) and SMD was within a 95% CI with respect to interstudy heterogeneity. Results 12 studies with 982 participants were identified. The quality presented a high risk of bias. Meta-analysis found that DJD combined with glucosamine (MD 4.20 (1.72 to 6.69); p<0.001) or DJD plus meloxicam and glucosamine (MD 3.48 (1.59 to 5.37); p<0.001) had a more significant effect in improving Western Ontario and McMaster Universities Arthritis Index (total WOMAC scores). Also, meta-analysis presented more remarkable pain improvement when DJD plus sodium hyaluronate injection (MD 0.89 (0.26 to 1.53); p=0.006) was used. These studies demonstrated that active treatment of DJD in combination should be practiced for at least 4 weeks. Information on the safety of DJD or comprehensive therapies was insufficient in few studies. Conclusions DJD combined with Western medicine or sodium hyaluronate injection appears to have benefits for KOA. However, the effectiveness and safety of DJD is uncertain because of the limited number of trials and low methodological quality. Therefore, practitioners should be cautious when applying DJD in daily practice. Future clinical trials should be well designed; more research is needed. PMID:26729379

  12. [Emphasis on the application of precision medicine in ophthalmology].

    PubMed

    Sun, X D; Zhu, H

    2016-02-01

    Accompany with dramatically growth of large-scale biological databases (such as human genome sequence), improvement of life science and development of international clinical trials, science offers great potential for improving health care through precision medicine. As a hot topic recently, precision medicine might launch a revolution of the methodology in medical research. How to achieve precision medicine in clinical ophthalmology by means of biological data mining is a challenge for ophthalmologist-scientists. The best approach for advanced individual medicine is to buildup the digital ophthalmology, which includes human eye biobank, national biological databases network, clinical department, basic research lab, and international clinical trial center. The system of digital ophthalmology could explore the methods for ophthalmology research, integrate the source of eye biologic databases, promote international cooperation, and thus eventually supply the opportunity for translational medicine.

  13. Sponsorship bias and quality of randomised controlled trials in veterinary medicine.

    PubMed

    Wareham, K J; Hyde, R M; Grindlay, D; Brennan, M L; Dean, R S

    2017-08-14

    Randomised controlled trials (RCTs) are considered the gold standard form of evidence for assessing treatment efficacy, but many factors can influence their reliability including methodological quality, reporting quality and funding source. The aim of this study was to examine the relationship between funding source and positive outcome reporting in veterinary RCTs published in 2011 and to assess the risk of bias in the RCTs identified. A structured search of PubMed was used to identify feline, canine, equine, bovine and ovine clinical trials examining the efficacy of pharmaceutical interventions published in 2011. Funding source and outcomes were extracted from each RCT and an assessment of risk of bias made using the Cochrane risk of bias tool. Literature searches returned 972 papers, with 86 papers (comprising 126 individual RCTs) included in the analysis. There was found to be a significantly higher proportion of positive outcomes reported in the pharmaceutical funding group (P) compared to the non-pharmaceutical (NP) and 'no funding source stated' (NF) groups (P = 56.9%, NP = 34.9%, NF = 29.1%, p < 0.05). A high proportion of trials had an unclear risk of bias across the five criteria examined. We found evidence that veterinary RCTs were more likely to report positive outcomes if they have pharmaceutical industry funding or involvement. Consistently poor reporting of trials, including non-identification of funding source, was found which hinders the use of the available evidence.

  14. From Planning to Implementation: An Examination of Changes in the Research Design, Sample Size, and Precision of Group Randomized Trials Launched by the Institute of Education Sciences

    ERIC Educational Resources Information Center

    Spybrook, Jessaca; Puente, Anne Cullen; Lininger, Monica

    2013-01-01

    This article examines changes in the research design, sample size, and precision between the planning phase and implementation phase of group randomized trials (GRTs) funded by the Institute of Education Sciences. Thirty-eight GRTs funded between 2002 and 2006 were examined. Three studies revealed changes in the experimental design. Ten studies…

  15. From Planning to Implementation: An Examination of Changes in the Research Design, Sample Size, and Precision of Group Randomized Trials Launched by the Institute of Education Sciences

    ERIC Educational Resources Information Center

    Spybrook, Jessaca; Puente, Anne Cullen; Lininger, Monica

    2013-01-01

    This article examines changes in the research design, sample size, and precision between the planning phase and implementation phase of group randomized trials (GRTs) funded by the Institute of Education Sciences. Thirty-eight GRTs funded between 2002 and 2006 were examined. Three studies revealed changes in the experimental design. Ten studies…

  16. Effect of oriental medicine music therapy on patients with Hwa-byung: a study protocol for a randomized controlled trial.

    PubMed

    Park, Jeong-Su; Park, Sunju; Cheon, Chun-Hoo; Jang, Bo-Hyoung; Lee, Song-Hee; Lee, Seung-Hyun; Chung, Sun-Yong; Kim, Jong-Woo; Jeon, Chan-Yong; Park, Jong-Hyeong; Shin, Yong-Cheol; Ko, Seong-Gyu

    2012-09-11

    Hwa-byung, a Korean culture-bound syndrome with both psychological and somatic symptoms, is also known as 'anger syndrome'. It includes various physical symptoms including anxiety, a feeling of overheating, a sensation of pressure on the chest, heart palpitations, respiratory stuffiness, insomnia, and anxiety. The proposed study is a single-center, double-blind, randomized, controlled trial with two parallel arms: an oriental medicine music therapy (OMMT) group and a control music therapy (CMT) group. In total, 48 patients will be enrolled into the trial. The first visit will be the screening visit. At baseline (visit 2), all participants fulfilling both the inclusion and the exclusion criteria will be split and randomly divided into two equal groups: the OMMT and the CMT (n = 24 each). Each group will receive treatment sessions over the course of 4 weeks, twice per week, for eight sessions in total. The primary outcome is the State-Trait Anxiety Inventory (STAI), and the secondary outcomes are the Hwa-byung scale (H-scale), the Center for Epidemiologic Studies Depression Scale (CES-D), the Hwa-byung visual analogue scale (H-VAS) for primary symptoms, the World Health Organization Quality of Life scale, brief version (WHOQOL-BREF), and levels of salivary cortisol. Patients will be asked to complete questionnaires at the baseline visit (visit 2), after the last treatment session (visit 9), and at 4 weeks after the end of all trial sessions (visit 10). From the baseline (visit 2) through the follow-up (visit 10), the entire process will take a total of 53 days. This proposed study targets patients with Hwa-byung, especially those who have exhibited symptoms of anxiety. Therefore, the primary outcome is set to measure the level of anxiety. OMMT is music therapy combined with traditional Korean medicinal theories. Unlike previously reported music therapies, for which patients simply listen to music passively, in OMMT, patients actively move their bodies and play the

  17. Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

    PubMed

    Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

    2010-01-01

    The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

  18. Chinese herbal medicine Guizhi Fuling Formula for treatment of uterine fibroids: a systematic review of randomised clinical trials

    PubMed Central

    2014-01-01

    Background Guizhi Fuling Formula is widely applied for uterine fibroids in China. Many clinical trials are reported. This study assessed the efficacy and safety of Guizhi Fuling Formula for the treatment of uterine fibroids. Methods PubMed, Cochrane CENTRAL, EMBASE, and four Chinese databases were searched through May 2013. We included randomised controlled trials (RCTs) that tested Guizhi Fuling Formula for uterine fibroids, compared with no intervention, placebo, pharmaceutical medication, or other Chinese patent medicines approved by the State Food and Drug Administration of China. Authors extracted data and assessed the quality independently. We applied RevMan 5.2.0 software to analyse data of included randomised trials. Results A total of 38 RCTs involving 3816 participants were identified. The methodological quality of the included trials was generally poor. Meta-analyses demonstrated that Guizhi Fuling Formula plus mifepristone were more effective than mifepristone alone in reducing the volume of fibroids (in total volume of multiple fibroids, MD −19.41 cm3, 95% CI −28.68 to −10.14; in average volume of multiple fibroids, MD −1.00 cm3, 95% CI −1.23 to −0.76; in average volume of maximum fibroids, MD −3.35 cm3, 95% CI −4.84 to −1.87, I2 = 93%, random effects model). Guizhi Fuling Formula significantly improved symptoms of dysmenorrhea either when it was used alone (RR 2.27, 95% CI 1.04 to 4.97) or in combination with mifepristone (RR 2.35, 95% CI 1.15 to 4.82). No serious adverse events were reported. Conclusions Guizhi Fuling Formula appears to have additional benefit based on mifepristone treatment in reducing volume of fibroids. However, due to high risk of bias of the trials, we could not draw confirmative conclusions on its benefit. Future clinical trials should be well-designed and avoid the issues that are identified in this study. PMID:24383676

  19. Clinical trial opportunities in Transfusion Medicine: proceedings of a National Heart, Lung, and Blood Institute State-of-the-Science Symposium.

    PubMed

    Blajchman, Morris A; Glynn, Simone A; Josephson, Cassandra D; Kleinman, Steve H

    2010-10-01

    The use of blood products to support patients undergoing the large variety of medical and surgical interventions requiring such support has continued to escalate very significantly over time. Relevantly, significant practice variation in the use of blood products exists among practitioners and institutions, largely because of the lack of robust clinical trial data, in many instances, which are critical for providing practitioners with evidence-based guidelines for appropriate blood product utilization. Recognizing this gap, the National Heart, Lung, and Blood Institute recently established a State-of-the-Science Symposium to help define areas of clinical trial research that would enhance the opportunity for developing appropriate practice guidelines for both Transfusion Medicine and Hemostasis/Thrombosis. Such a Symposium was held in September 2009 to identify important clinical trial research issues in these 2 subject areas of endeavor. The aims of this Symposium were to specifically identify phase 2 and 3 clinical trials that, if conducted over the next 5 to 10 years, could impact the treatment of patients with hemostatic and other disorders as well as to optimize the use of blood products in patients who need such interventions. This article reports on the deliberations that were held relating to the various clinical trial concepts developed by 7 Transfusion Medicine subcommittees. This Symposium generated a rich assortment of clinical trial proposals that will undergo further refinement before final implementation into pilot or full randomized clinical trials. The various proposals identified many opportunities for clinical trial research and most importantly underscored the ongoing need for well-developed evidence-based clinical trial research in the field of Transfusion Medicine.

  20. The first ever Cochrane event in Russia and Russian speaking countries - Cochrane Russia Launch - Evidence-based medicine: Achievements and barriers (QiQUM 2015) International Conference, Kazan, December 7-8, 2015.

    PubMed

    Ziganshina, Liliya Eugenevna; Jørgensen, Karsten Juhl

    2016-01-01

    Kazan hosted Russia's second International Conference QiQUM 2015 on Cochrane evidence for health policy, which was entirely independent of the pharmaceutical or other health industry, bringing together 259 participants from 11 countries and 13 regions of the Russian Federation. The Conference was greeted and endorsed by world leaders in Evidence-based medicine, health and pharmaceutical information, policy and regulation, and the World Health Organization. Participants discussed the professional and social problems arising from biased health information, unethical pharmaceutical promotion, misleading reporting of clinical trials with consequent flaws in health care delivery and the role of Cochrane evidence for informed decisions and better health. The first in history Cochrane workshop, facilitated jointly by experts from Cochrane and the WHO, with 40 participants from Kazakhstan, Kyrgyzstan, Tajikistan and Russia introduced the concept of Cochrane systematic review and the Use of Cochrane evidence in WHO policy setting. Websites document conference materials and provide interface for future collaboration: http://kpfu.ru/biology-medicine/struktura-instituta/kafedry/kfikf/konferenciya/mezhdunarodnaya-konferenciya-39dokazatelnaya.html and http://russia.cochrane.org/news/international-conference.

  1. Can attention control conditions have detrimental effects on behavioral medicine randomized trials?

    PubMed

    Pagoto, Sherry L; McDermott, Mary M; Reed, George; Greenland, Philip; Mazor, Kathy M; Ockene, Judith K; Whited, Matt; Schneider, Kristin; Appelhans, Brad; Leung, Kathy; Merriam, Philip; Ockene, Ira

    2013-02-01

    Attention control (AC) conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance about which behavioral interventions and outcomes merit AC is available in the literature. The primary aim of the present study is to demonstrate a scenario in which use of AC in a behavioral randomized trial was unnecessary and possibly detrimental. Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered counseling intervention reduced low-density lipoprotein cholesterol levels in 355 participants with peripheral arterial disease, compared with AC and usual care (UC) conditions. The patient-centered counseling intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched telephone-delivered health education, and the UC condition consisted of an educational pamphlet. At 12-month follow-up, the mean low-density lipoprotein cholesterol changes were -11.1 and -6.8 mg/dL in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased the use or dose intensity of medication was significantly lower in AC than in UC: 17.5% versus 30.5% (p=.03). No significant difference in other outcomes was observed between AC and UC. AC has significantly worse medication outcomes, and there is no indication of a therapeutic effect on other end points. Implications for the use of AC in behavioral randomized trials are discussed. clinicaltrials.gov Identifier: NCT00217919.

  2. Can attention control conditions have detrimental effects in behavioral medicine randomized trials?

    PubMed Central

    Pagoto, Sherry; McDermott, Mary M.; Reed, George; Greenland, Philip; Mazor, Kathy M.; Ockene, Judith K.; Whited, Matt; Schneider, Kristin; Appelhans, Brad; Leung, Kathy; Merriam, Philip; Ockene, Ira

    2012-01-01

    Objective Attention control conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance is available in the literature about which behavioral interventions and outcomes merit an attention control. The primary aim of the present paper is to demonstrate a scenario in which use of attention control in a behavioral randomized trial was unnecessary and possibly detrimental. Methods Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered telephone counseling (PC) intervention reduced low-density lipoprotein cholesterol (LDL-C) levels in 355 participants with peripheral arterial disease (PAD), compared to attention control (AC) and usual care (UC) conditions. The PC intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched phone-delivered health education, and the UC condition consisted of an educational pamphlet. Results At 12-month follow-up, mean LDL-C changes were −11.1, and −6.8 mg/dl in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased use or dose intensity of medication was significantly lower in AC than UC, 17.5% versus 30.5% (p=0.03). No significant difference between AC and UC were observed on other outcomes. Conclusions The AC had significantly worse medication outcomes and there was no indication of a therapeutic effect on other endpoints. Implications for use of attention control in behavioral randomized trials are discussed. PMID:23197844

  3. Chinese Herbal Medicine for Postpartum Depression: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Li, Yongle; Chen, Zijie; Yu, Ning; Yao, Keyu; Che, Yiwen; Xi, Yupeng

    2016-01-01

    Background. Postpartum depression (PPD) does great harm to women following childbirth. The aim of this study was to conduct a systematic review of the literature to assess the efficacy and safety of CHM for the treatment of PPD. Methods. Published or ongoing registered trials were searched for from the inception of the various databases to December 31, 2015. Data extraction and methodology assessment were conducted independently by two researchers. RevMan 5.3 software was used to analyze the data. Results. Forty-seven registered clinical trials (RCTs) were identified and reviewed. The results showed CHM alone or in combination with routine treatments could reduce HAMD score, EPDS score, incidence of adverse events, TESS, and SERS. CHM combined with routine treatment was more effective in increasing serum estradiol levels and reducing progesterone levels than routine treatment alone. Meanwhile, pooled data revealed that MRLQS combined with routine treatments or MRLQS plus MSHS combined with routine treatments were more effective than other therapeutic methods in TCM. MRLQS plus MSHS alone was found to be an effective alternative when compared to routine treatments. Conclusions. This review suggested that CHM was safe and effective in the treatment of PPD. However, this could not be proven conclusively. To ensure evidence-based clinical practice, more rigorously designed trials are warranted. PMID:27774110

  4. Fifth FLTSATCOM to be launched

    NASA Technical Reports Server (NTRS)

    1981-01-01

    Launch of the FLTSATOOM-E, into an elliptical orbit by the Atlas Centaur launch vehicle is announced. The launch and relevant launch operations are described. A chart of the launch sequence for FLTSATCOM-E communication satellite is given.

  5. Lab Plays Central Role in Groundbreaking National Clinical Trial in Precision Medicine | Poster

    Cancer.gov

    The Molecular Characterization Laboratory lies at the heart of an ambitious new approach for testing cancer drugs that will use the newest tools of precision medicine to select the best treatment for individual patients based on the genetic makeup of their tumors. The protocol, called NCI-Molecular Analysis for Therapy Choice (NCI-MATCH), will start with tumor biopsies from as many as 3,000 patients to see if they have genetic defects for which a targeted cancer drug is available. Cancers will be treated based on their genetic profiles rather than by their location in the body, which is the conventional approach.

  6. Lab Plays Central Role in Groundbreaking National Clinical Trial in Precision Medicine | Poster

    Cancer.gov

    The Molecular Characterization Laboratory lies at the heart of an ambitious new approach for testing cancer drugs that will use the newest tools of precision medicine to select the best treatment for individual patients based on the genetic makeup of their tumors. The protocol, called NCI-Molecular Analysis for Therapy Choice (NCI-MATCH), will start with tumor biopsies from as many as 3,000 patients to see if they have genetic defects for which a targeted cancer drug is available. Cancers will be treated based on their genetic profiles rather than by their location in the body, which is the conventional approach.

  7. Traditional Chinese medicine (Shun-Qi-Tong-Xie Granule) for irritable bowel syndrome: study protocol for a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Irritable bowel syndrome (IBS) is a common gastrointestinal functional disorder with no effective therapy. Traditional Chinese medicine (TCM) is one of the most common complementary therapies in China. We designed this study to evaluate the efficacy and safety of Shun-Qi-Tong-Xie Granule (SQTX Granule), a TCM treatment, in patients with IBS with diarrhea (IBS-D). Methods/Design A randomised, double-blinded, placebo-controlled, multi-centre, superiority clinical trial to evaluate the efficacy and safety of SQTX Granule is proposed. Eligible patients (Rome III) with IBD-S will be randomly assigned into SQTX Granule group and the placebo group. Patients will receive a 28-day treatment and a 2-month follow-up. The primary outcome measures include the scores of IBS-quality of life (IBS-QOL) rating scale and IBS-symptom severity scale (IBS-SSS) rating scale. The secondary outcome measures include the improvement of symptom scores, and the duration of abdominal pain and diarrhea. Discussion According to TCM theory, SQTX Granule has a regulating effect on abdominal pain, diarrhea and the syndrome of liver-spleen disharmony, which is similar to the symptoms of IBS-D. This study will provide objective evidence to evaluate the efficiency and safety of SQTX Granule in IBS-D treatment. Trial registration ChiCTR-TRC-14004241. Date of registration: 9 February 2014. PMID:25002196

  8. A randomised-controlled trial of two educational modes for undergraduate evidence-based medicine learning in Asia

    PubMed Central

    Johnston, Janice M; Schooling, C Mary; Leung, Gabriel M

    2009-01-01

    Background As the overall evidence for the effectiveness of teaching of evidence based medicine (EBM) is not strong, and the impact of cultural and societal influences on teaching method is poorly understood, we undertook a randomised-controlled trial to test the effectiveness and learning satisfaction with two different EBM teaching methods (usual teaching vs. problem based learning (PBL)) for undergraduate medical students. Methods A mixed methods study that included a randomised-controlled crossover trial with two intervention arms (usual teaching and PBL) and a nested qualitative study with focus groups to explore student perceptions of learning and to assess the effectiveness and utility of the two teaching methods. All 129 second-year medical students at the University of Hong Kong in 2007. The main outcomes measures were attitudes towards EBM; personal application and current use of EBM; EBM knowledge; future use of EBM. Results PBL was less effective at imparting knowledge than usual teaching consisting of a lecture followed by a group tutorial. After usual teaching students showed improvement in scores for 'attitudes towards EBM', 'personal application and current use of EBM' and 'EBM knowledge, which were not evident after PBL. In contrast to the usual teaching, students found PBL difficult as they lacked the statistical knowledge necessary to support discussion, failed to understand core concepts, and lost direction. Conclusion The evidence presented here would suggest that the teaching of EBM within an Asian environment should adopt a format that facilitates both the acquisition of knowledge and encourages enquiry. PMID:19785777

  9. A randomised-controlled trial of two educational modes for undergraduate evidence-based medicine learning in Asia.

    PubMed

    Johnston, Janice M; Schooling, C Mary; Leung, Gabriel M

    2009-09-29

    As the overall evidence for the effectiveness of teaching of evidence based medicine (EBM) is not strong, and the impact of cultural and societal influences on teaching method is poorly understood, we undertook a randomised-controlled trial to test the effectiveness and learning satisfaction with two different EBM teaching methods (usual teaching vs. problem based learning (PBL)) for undergraduate medical students. A mixed methods study that included a randomised-controlled crossover trial with two intervention arms (usual teaching and PBL) and a nested qualitative study with focus groups to explore student perceptions of learning and to assess the effectiveness and utility of the two teaching methods.All 129 second-year medical students at the University of Hong Kong in 2007.The main outcomes measures were attitudes towards EBM; personal application and current use of EBM; EBM knowledge; future use of EBM. PBL was less effective at imparting knowledge than usual teaching consisting of a lecture followed by a group tutorial. After usual teaching students showed improvement in scores for 'attitudes towards EBM', 'personal application and current use of EBM' and 'EBM knowledge, which were not evident after PBL. In contrast to the usual teaching, students found PBL difficult as they lacked the statistical knowledge necessary to support discussion, failed to understand core concepts, and lost direction. The evidence presented here would suggest that the teaching of EBM within an Asian environment should adopt a format that facilitates both the acquisition of knowledge and encourages enquiry.

  10. IRIS Launch Animation

    NASA Image and Video Library

    This animation demonstrates the launch and deployment of NASA's Interface Region Imaging Spectrograph (IRIS) mission satellite via a Pegasus rocket. The launch is scheduled for June 26, 2013 from V...

  11. Shuttle Era: Launch Directors

    NASA Image and Video Library

    A space shuttle launch director is the leader of the complex choreography that goes into a shuttle liftoff. Ten people have served as shuttle launch directors, making the final decision whether the...

  12. Space Launch System Animation

    NASA Image and Video Library

    NASA is ready to move forward with the development of the Space Launch System -- an advanced heavy-lift launch vehicle that will provide an entirely new national capability for human exploration be...

  13. Medical Students' and Tutors' Experiences of Directed and Self-Directed Learning Programs in Evidence-Based Medicine: A Qualitative Evaluation Accompanying a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bradley, Peter; Oterholt, Christina; Nordheim, Lena; Bjorndal, Arild

    2005-01-01

    This qualitative study aims to interpret the results of a randomized controlled trial comparing two educational programs (directed learning and self-directed learning) in evidence-based medicine (EBM) for medical students at the University of Oslo from 2002 to 2003. There is currently very little comparative educational research in this field. In…

  14. The effects of two Chinese herbal medicinal formulae vs. placebo controls for treatment of allergic rhinitis: a randomised controlled trial.

    PubMed

    Chan, Rose Y P; Chien, Wai Tong

    2014-07-02

    Allergic rhinitis is a chronic illness, affecting 10 to 40% of the worldwide population. Chinese herbal medicines, the treatment of allergic rhinitis, adopted thousands of years in ancient China, has recently raised much attention among researchers globally. This study evaluates the effects of two Chinese herbal formulae [Cure-allergic-rhinitis Syrup (CS) and Yu-ping-feng San (YS)] in treating undergraduate nursing students with allergic rhinitis over a 3-month follow-up, when compared to a placebo control group. A double-blind, randomised controlled trial with repeated-measures, three-parallel-groups design was conducted in a random sample of 249 participants recruited from one university in Hong Kong. After baseline measurements, participants were randomly assigned to CS, YS, or placebo groups (n=83 per group). The main outcomes, including symptom severity, quality of life, and body constitution, were measured with self-administered questionnaires at baseline and immediately, 1 and 3 months after the 4-week interventions. 240 participants completed the trial, with 9 (3.6%) drop-outs. The results of Generalised Estimating Equations test followed by pairwise contrasts tests indicated that the participants who received CS showed significantly greater reduction of symptoms (mean difference of CS vs. placebo=26.13-34.55, P<0.0005) and improvements in quality of life (mean difference of CS vs. placebo=12.81-16.76, P<0.001), and body constitution in 'Qi-deficiency', 'Yang-deficiency', and 'Inherited Special' (mean difference of CS vs. placebo=7.05-8.12, 7.56-8.92, and 4.48-8.10, P=0.01-< 0.0005, 0.001-0.004, and 0.01-< 0.0005, accordingly, at three post-tests). The participants who received YS also indicated significant greater improvements in symptom severity, quality of life, and a few patterns of body constitution when compared to the placebo group. However, its effects were lesser in strength (i.e., smaller effect sizes), varieties of symptoms, and body

  15. Complementary therapies for labour and birth study: a randomised controlled trial of antenatal integrative medicine for pain management in labour

    PubMed Central

    Levett, Kate M; Smith, C A; Bensoussan, A; Dahlen, H G

    2016-01-01

    Objective To evaluate the effect of an antenatal integrative medicine education programme in addition to usual care for nulliparous women on intrapartum epidural use. Design Open-label, assessor blind, randomised controlled trial. Setting 2 public hospitals in Sydney, Australia. Population 176 nulliparous women with low-risk pregnancies, attending hospital-based antenatal clinics. Methods and intervention The Complementary Therapies for Labour and Birth protocol, based on the She Births and acupressure for labour and birth courses, incorporated 6 evidence-based complementary medicine techniques: acupressure, visualisation and relaxation, breathing, massage, yoga techniques, and facilitated partner support. Randomisation occurred at 24–36 weeks’ gestation, and participants attended a 2-day antenatal education programme plus standard care, or standard care alone. Main outcome measures Rate of analgesic epidural use. Secondary: onset of labour, augmentation, mode of birth, newborn outcomes. Results There was a significant difference in epidural use between the 2 groups: study group (23.9%) standard care (68.7%; risk ratio (RR) 0.37 (95% CI 0.25 to 0.55), p≤0.001). The study group participants reported a reduced rate of augmentation (RR=0.54 (95% CI 0.38 to 0.77), p<0.0001); caesarean section (RR=0.52 (95% CI 0.31 to 0.87), p=0.017); length of second stage (mean difference=−0.32 (95% CI −0.64 to 0.002), p=0.05); any perineal trauma (0.88 (95% CI 0.78 to 0.98), p=0.02) and resuscitation of the newborn (RR=0.47 (95% CI 0.25 to 0.87), p≤0.015). There were no statistically significant differences found in spontaneous onset of labour, pethidine use, rate of postpartum haemorrhage, major perineal trauma (third and fourth degree tears/episiotomy), or admission to special care nursery/neonatal intensive care unit (p=0.25). Conclusions The Complementary Therapies for Labour and Birth study protocol significantly reduced epidural use and caesarean section. This

  16. STS-135 Atlantis Launch

    NASA Image and Video Library

    2011-07-07

    NASA Administrator Charles Bolden, right, participates in the post launch traditional beans and cornbread at the NASA Kennedy Space Center, Launch Control Center (LCC) shortly after the space shuttle Atlantis, STS-135, launched on Friday, July 8, 2011, in Cape Canaveral, Fla. The launch of Atlantis is the final flight of the shuttle program, a 12-day mission to the International Space Station. Photo Credit: (NASA/Bill Ingalls)

  17. Launch Vehicle Operations Simulator

    NASA Technical Reports Server (NTRS)

    Blackledge, J. W.

    1974-01-01

    The Saturn Launch Vehicle Operations Simulator (LVOS) was developed for NASA at Kennedy Space Center. LVOS simulates the Saturn launch vehicle and its ground support equipment. The simulator was intended primarily to be used as a launch crew trainer but it is also being used for test procedure and software validation. A NASA/contractor team of engineers and programmers implemented the simulator after the Apollo XI lunar landing during the low activity periods between launches.

  18. STS-135 Atlantis Launch

    NASA Image and Video Library

    2011-07-07

    NASA Photographer Kim Shiflett, left, and Videographer Glenn Benson capture a group photo of the launch team in Firing Room Four of the NASA Kennedy Space Center Launch Control Center (LCC) shortly after the space shuttle Atlantis, STS-135, launched on Friday, July 8, 2011, in Cape Canaveral, Fla. The launch of Atlantis is the final flight of the shuttle program, a 12-day mission to the International Space Station. Photo Credit: (NASA/Bill Ingalls)

  19. STS-135 Atlantis Launch

    NASA Image and Video Library

    2011-07-07

    NASA Kennedy Space Center worker Dwayne Hutcheson sweeps the Launch Control Center (LCC) lobby floor in preparation for the post launch tradition of corn bread and beans after a successful launch of the space shuttle Atlantis from pad 39A on Friday, July 8, 2011, in Cape Canaveral, Fla. The launch of Atlantis, STS-135, is the final flight of the shuttle program, a 12-day mission to the International Space Station. Photo Credit: (NASA/Bill Ingalls)

  20. Effects of herbal medicine for dysmenorrhea treatment on accompanied acne vulgaris: a study protocol for a randomized controlled trial.

    PubMed

    Kim, Kwan-Il; Nam, Hae Jeong; Kim, Mia; Lee, Junhee; Kim, Kyuseok

    2017-06-17

    The incidence of preadolescent acne among women is increasing. Acne deteriorates the quality of life; conventional treatment options are limited and have not been effective against acne, particularly acne associated with menstruation. Despite evidence that acne associated with menstruation abnormalities naturally improves when menstruation recovers to normal, there have only been few studies on the effects of dysmenorrhea treatment on acne. Therefore- we designed this study to assess the effects of gyejibokryung-hwan (GBH) and dangguijagyag-san (DJS), which are widely used in dysmenorrhea treatment, on acne associated with menstruation cycle. This is a protocol for a randomized, double-blind, parallel-group, placebo-controlled and multicenter trial. One hundred and sixteen participants with dysmenorrhea accompanied by acne vulgaris will be recruited at three centers and randomized into two groups, the herbal treatment group and placebo group. The participants will receive GBH or DJS based on pattern identification or placebo granules thrice daily for 8 weeks, with an 8-week follow up. The primary outcome will be the mean percentage change in the count of inflammatory acne lesions. The secondary outcomes would be based on dysmenorrhea numeric rating scale, verbal multidimensional scoring system for dysmenorrhea, acne numeric rating scale, investigator's static global assessment scale of facial acne vulgaris, and safety testing. Adverse events will also be reported. The effects of GBH or DJS used in dysmenorrhea treatment on acne associated with the menstrual cycle will be evaluated. The findings of this trial will provide evidence regarding the effect of herbal medicine in improving acne vulgaris associated with menstruation in women. Korean Clinical Trial Registry ( http://cris.nih.go.kr ; registration number: KCT0002259). Date of registration: March 10, 2017.

  1. Are meta-analyses of Chinese herbal medicine trials trustworthy and clinically applicable? A cross-sectional study.

    PubMed

    Chung, Vincent C H; Ho, Robin S T; Wu, Xinyin; Fung, Daisy H Y; Lai, Xin; Wu, Justin C W; Wong, Samuel Y S

    2015-03-13

    Meta-analysis (MA) on Chinese herbal medicine (CHM) trials is increasingly published and indexed in major international databases but their trustworthiness and clinical applicability is uncertain. We aimed to assess the characteristics and methodological quality of MA on CHM. Cross-sectional study. MA published during 1993-2013 was sampled from MEDLINE, EMBASE, Cochrane Database of Systematic Reviews and Database of Abstracts of Reviews of Effect. Bibliographical characteristics were abstracted and methodological quality was assessed using the validated AMSTAR tool by two independent reviewers. Total of 201 MA were included and half were published in or after 2009. Only 7.5% being updates of previous reviews. Majority are published in journals with low or no impact factor, with a median of 1.5. These MA demonstrated methodological strengths in ensuring comprehensive literature search, providing characteristics of the included studies, assessing the scientific quality of included studies and appropriately using the scientific quality of included studies in formulating conclusions. Nevertheless, weaknesses in protocol provision, listing of included and excluded studies, inclusion of grey literature, use of appropriate meta-analytic technique as well as reporting of funding sources were prevalent. CHM and control interventions pooled in majority of MA are found to have substantial clinical heterogeneity in terms of composition, dosage form and route of administration. There are rooms for improvement in methodological rigor, and in choosing clinically homogenous interventions and control for statistical pooling. These shortcomings limit the trustworthiness and clinical applicability of existing MA on CHM trials. To overcome the limitations of pair-wise meta-analysis in synthesizing trials comparing different CHM and control interventions, the potential of network meta-analysis should be explored. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  2. Launch Summary for 1979

    NASA Technical Reports Server (NTRS)

    Vostreys, R. W.

    1980-01-01

    Spacecraft launching for 1979 are identified and listed under the categories of (1) sounding rockets, and (2) artificial Earth satellites and space probes. The sounding rockets section includes a listing of the experiments, index of launch sites and tables of the meanings and codes used in the launch listing.

  3. LAUNCH Health Forum

    NASA Image and Video Library

    2010-10-30

    Tom Kalil, Deputy Director of the White House Office of Science and Technology Policy, opens the LAUNCH: Health forum at NASA's Kennedy Space Center in Florida on Saturday, Oct. 30, 2010. LAUNCH: Health provides a forum to discuss accelerating innovation for a sustainable future. LAUNCH: Health partners include NASA, USAID and Nike. Photo Credit: (NASA/Bill Ingalls)

  4. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial.

    PubMed

    Ellis, Ronald J; Toperoff, Will; Vaida, Florin; van den Brande, Geoffrey; Gonzales, James; Gouaux, Ben; Bentley, Heather; Atkinson, J Hampton

    2009-02-01

    Despite management with opioids and other pain modifying therapies, neuropathic pain continues to reduce the quality of life and daily functioning in HIV-infected individuals. Cannabinoid receptors in the central and peripheral nervous systems have been shown to modulate pain perception. We conducted a clinical trial to assess the impact of smoked cannabis on neuropathic pain in HIV. This was a phase II, double-blind, placebo-controlled, crossover trial of analgesia with smoked cannabis in HIV-associated distal sensory predominant polyneuropathy (DSPN). Eligible subjects had neuropathic pain refractory to at least two previous analgesic classes; they continued on their prestudy analgesic regimens throughout the trial. Regulatory considerations dictated that subjects smoke under direct observation in a hospital setting. Treatments were placebo and active cannabis ranging in potency between 1 and 8% Delta-9-tetrahydrocannabinol, four times daily for 5 consecutive days during each of 2 treatment weeks, separated by a 2-week washout. The primary outcome was change in pain intensity as measured by the Descriptor Differential Scale (DDS) from a pretreatment baseline to the end of each treatment week. Secondary measures included assessments of mood and daily functioning. Of 127 volunteers screened, 34 eligible subjects enrolled and 28 completed both cannabis and placebo treatments. Among the completers, pain relief was greater with cannabis than placebo (median difference in DDS pain intensity change, 3.3 points, effect size=0.60; p=0.016). The proportions of subjects achieving at least 30% pain relief with cannabis versus placebo were 0.46 (95%CI 0.28, 0.65) and 0.18 (0.03, 0.32). Mood and daily functioning improved to a similar extent during both treatment periods. Although most side effects were mild and self-limited, two subjects experienced treatment-limiting toxicities. Smoked cannabis was generally well tolerated and effective when added to concomitant analgesic

  5. Precision Medicine in NCI’s National Clinical Trials Network: Progress and Lessons Learned

    Cancer.gov

    NCI’s Jeff Abrams, M.D., Acting Director for Clinical Research in the Division of Cancer Treatment and Diagnosis (DCTD) and Associate Director of the Cancer Therapy Evaluation Program (CTEP) and Nita Seibel, M.D., Head of the Pediatric Solid Tumor Therapeutics in the Clinical Investigations Branch of CTEP, DCTD will host a Google Hangout on Air. The discussion will be moderated by Andrea Denicoff, R.N., N.P, Head, NCTN Clinical Trials Operations in the Investigational Drug Branch of CTEP, DCTD.

  6. Precision Medicine in NCI’s National Clinical Trials Network: Progress and Lessons Learned

    Cancer.gov

    NCI’s Jeff Abrams, M.D., Acting Director for Clinical Research in the Division of Cancer Treatment and Diagnosis (DCTD) and Associate Director of the Cancer Therapy Evaluation Program (CTEP) and Nita Seibel, M.D., Head of the Pediatric Solid Tumor Therapeutics in the Clinical Investigations Branch of CTEP, DCTD will host a Google Hangout on Air. The discussion will be moderated by Andrea Denicoff, R.N., N.P, Head, NCTN Clinical Trials Operations in the Investigational Drug Branch of CTEP, DCTD.

  7. The Traditional Chinese Medicine and Relevant Treatment for the Efficacy and Safety of Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Shi, Zhao-feng; Song, Tie-bing; Xie, Juan; Yan, Yi-quan

    2017-01-01

    Background Atopic dermatitis (AD) has become a common skin disease that requires systematic and comprehensive treatment to achieve adequate clinical control. Traditional Chinese medicines and related treatments have shown clinical effects for AD in many studies. But the systematic reviews and meta-analyses for them are lacking. Objective The systematic review and meta-analysis based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement were conducted to evaluate the efficacy and safety of traditional Chinese medicines and related treatments for AD treatment. Methods Randomized controlled trials (RCTs) were searched based on standardized searching rules in eight medical databases from the inception up to December 2016 and a total of 24 articles with 1,618 patients were enrolled in this meta-analysis. Results The results revealed that traditional Chinese medicines and related treatments did not show statistical differences in clinical effectiveness, SCORAD amelioration, and SSRI amelioration for AD treatment compared with control group. However, EASI amelioration of traditional Chinese medicines and related treatments for AD was superior to control group. Conclusion We need to make conclusion cautiously for the efficacy and safety of traditional Chinese medicine and related treatment on AD therapy. More standard, multicenter, double-blind randomized controlled trials (RCTs) of traditional Chinese medicine and related treatment for AD were required to be conducted for more clinical evidences providing in the future. PMID:28713436

  8. Sports medicine clinical trial research publications in academic medical journals between 1996 and 2005: an audit of the PubMed MEDLINE database.

    PubMed

    Nichols, A W

    2008-11-01

    To identify sports medicine-related clinical trial research articles in the PubMed MEDLINE database published between 1996 and 2005 and conduct a review and analysis of topics of research, experimental designs, journals of publication and the internationality of authorships. Sports medicine research is international in scope with improving study methodology and an evolution of topics. Structured review of articles identified in a search of a large electronic medical database. PubMed MEDLINE database. Sports medicine-related clinical research trials published between 1996 and 2005. Review and analysis of articles that meet inclusion criteria. Articles were examined for study topics, research methods, experimental subject characteristics, journal of publication, lead authors and journal countries of origin and language of publication. The search retrieved 414 articles, of which 379 (345 English language and 34 non-English language) met the inclusion criteria. The number of publications increased steadily during the study period. Randomised clinical trials were the most common study type and the "diagnosis, management and treatment of sports-related injuries and conditions" was the most popular study topic. The knee, ankle/foot and shoulder were the most frequent anatomical sites of study. Soccer players and runners were the favourite study subjects. The American Journal of Sports Medicine had the highest number of publications and shared the greatest international diversity of authorships with the British Journal of Sports Medicine. The USA, Australia, Germany and the UK produced a good number of the lead authorships. In all, 91% of articles and 88% of journals were published in English. Sports medicine-related research is internationally diverse, clinical trial publications are increasing and the sophistication of research design may be improving.

  9. Launch summary for 1980

    NASA Technical Reports Server (NTRS)

    Vostreys, R. W.

    1981-01-01

    Sounding rockets, artificial Earth satellites, and space probes launched betweeen January 1 and December 31, 1980 are listed. Data tabulated for the rocket launchings show launching site, instruments carried, date of launch, agency rocket identification, sponsoring country, experiment discipline, peak altitude, and the experimenter or institution responsible. Tables for satellites and space probes show COSPAR designation, spacecraft name, country, launch date, epoch date, orbit type, apoapsis, periapsis and inclination period. The functions and responsibilities of the World Data Center and the areas of scientific interest at the seven subcenters are defined. An alphabetical listing of experimenters using the sounding rockets is also provided.

  10. The Rockot launch system

    NASA Astrophysics Data System (ADS)

    Stamerjohanns, G.; Kinnersley, M.

    1999-09-01

    EUROCKOT Launch Services GmbH has been founded by Daimler-Benz Aerospace of Germany and Khrunichev State Research and Production Space Center of Russia to offer world-wide cost effective launch services on the Rockot launch system. The Rockot commercial program is described. Rockot can launch satellites weighing up to 1850 kg into polar and other low earth (LEO) orbits. The Rockot launch vehicle is based on the former Russian SS-19 strategic missile. The first and second stages are inherited from the SS-19, the third stage named Breeze is newly developed and has multiple ignition capability. The Rockot launch system is flight proven. In addition to the currently adapted Rockot launch site Plesetsk for high inclinations, EUROCKOT is in the process to also adapt the Baykonur cosmodrome as their complementary Rockot launch site for lower inclinations. The wide range of Rockot performance is provided. The first commercial launch is foreseen in the middle of 1999. The expected launch capacity for Plesetsk and Baykonur will exceed 10 launches per year. The complete Rockot system including performance is presented.

  11. CCRM: cultivating a culture of cooperation to advance the global regenerative medicine industry.

    PubMed

    Evans, Alanna; Johnson, Stacey

    2016-12-01

    Launched in June 2011, CCRM is a unique, Canadian, not-for-profit group that is solely focused on developing and commercializing regenerative medicine, cell and gene therapy technologies. Its mission is to generate sustainable health and economic benefits through global collaborations, and its vision is to be the preferred destination for the best people and companies, technologies, clinical trials and investments in cell and gene therapies, and regenerative medicine.

  12. Electron launching voltage monitor

    DOEpatents

    Mendel, Clifford W.; Savage, Mark E.

    1992-01-01

    An electron launching voltage monitor measures MITL voltage using a relationship between anode electric field and electron current launched from a cathode-mounted perturbation. An electron launching probe extends through and is spaced from the edge of an opening in a first MITL conductor, one end of the launching probe being in the gap between the MITL conductor, the other end being adjacent a first side of the first conductor away from the second conductor. A housing surrounds the launching probe and electrically connects the first side of the first conductor to the other end of the launching probe. A detector detects the current passing through the housing to the launching probe, the detected current being representative of the voltage between the conductors.

  13. Electron launching voltage monitor

    DOEpatents

    Mendel, C.W.; Savage, M.E.

    1992-03-17

    An electron launching voltage monitor measures MITL voltage using a relationship between anode electric field and electron current launched from a cathode-mounted perturbation. An electron launching probe extends through and is spaced from the edge of an opening in a first MITL conductor, one end of the launching probe being in the gap between the MITL conductor, the other end being adjacent a first side of the first conductor away from the second conductor. A housing surrounds the launching probe and electrically connects the first side of the first conductor to the other end of the launching probe. A detector detects the current passing through the housing to the launching probe, the detected current being representative of the voltage between the conductors. 5 figs.

  14. Personalized medicine in metastatic non-small-cell lung cancer: promising targets and current clinical trials

    PubMed Central

    Black, A.; Morris, D.

    2012-01-01

    Non-small-cell lung cancer (nsclc) remains the leading cause of cancer-related death globally, with most patients presenting with non-curable disease. Platinum-based doublet chemotherapy has been the cornerstone of treatment for patients with advanced-stage disease and has resulted in a modest increase in overall survival (on the order of an incremental 2 months increased survival per decade) and quality of life. Improved knowledge of the molecular signalling pathways found in nsclc has led to the development of biomarkers with associated targeted therapeutics, thus changing the treatment paradigm for many nsclc patients. In this review, we present a summary of many of the currently investigated nsclc targets, discuss their current clinical trial status, and provide commentary as to the likelihood of their success making a positive impact for nsclc patients. PMID:22787415

  15. Updated clinical evidence of Chinese herbal medicine for insomnia: a systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Ni, Xiaojia; Shergis, Johannah Linda; Guo, Xinfeng; Zhang, Anthony Lin; Li, Yan; Lu, Chuanjian; Xue, Charlie Changli

    2015-12-01

    This systematic review is to evaluate the efficacy and safety of Chinese herbal medicine (CHM) for people with insomnia. Randomized controlled trials (RCTs) investigating oral CHM alone or in combination with conventional therapies for primary insomnia were identified by searching English and Chinese publications and databases of clinical trial registration. Risk of bias was assessed according to the Cochrane Handbook 5.1. Meta-analysis was conducted using RevMan 5.2.4. Seventy-nine trials (7886 participants) were finally included in the review, and 76 were included in the meta-analysis. Twenty-seven trials reported the methods of random sequence generation, and five of them used the allocation concealment. Blinding of participants and personnel were used in 10 studies. The main meta-analysis showed that CHM alone was more effective than placebo by reducing scores of Pittsburgh Sleep Quality Index (mean difference, MD: -3.06, 95% confidence interval, CI: -5.14 to -0.98, I(2) = 97%) and benzodiazepine drugs (BZDs) (MD: -1.94, 95% CI: -2.45 to -1.43, I(2) = 96%). The effect was also seen when CHM was combined with BZDs compared with placebo plus BZDs (MD: -1.88, 95% CI: -2.78 to -0.97, I(2) = 0%) or cognitive and behavioral therapy (MD: -3.80, 95% CI: -4.91 to -2.68, I(2) = 68%) alone. There was no significant difference between CHM and placebo regarding the frequency of adverse events (relative risk, RR: 1.65, 95% CI: 0.67-4.10, I(2) = 0). Overall, oral CHM used as a monotherapy or as an adjunct to conventional therapies appears safe, and it may improve subjective sleep in people with insomnia. However, the typical effect of CHM for insomnia cannot be determined due to heterogeneity. Further study focusing on individual CHM formula for insomnia is needed. The development of a comparable placebo is also needed to improve the successful blinding in RCTs.

  16. Complementary medicine.

    PubMed

    Ernst, E

    2003-03-01

    Complementary medicine has become an important subject for rheumatologists, not least because many patients try complementary treatments. Recent clinical trials yield promising results. In particular, evidence suggests that several herbal medicines and dietary supplements can alleviate the pain of osteoarthritis and rheumatoid arthritis. Clearly, rigorous testing of complementary treatments is possible, and considering their popularity, should be encouraged.

  17. [Chinese herbal medicine for patients with mild to moderate Alzheimer disease based on syndrome differentiation: a randomized controlled trial].

    PubMed

    Yu, Lu; Lin, Shui-miao; Zhou, Ru-qian; Tang, Wei-jun; Huang, Pin-xian; Dong, Ying; Wang, Jian; Yu, Zhi-hua; Chen, Jiu-lin; Wei, Li; Xing, San-li; Cao, Hui-juan; Zhao, Hong-bin

    2012-07-01

    Alzheimer disease (AD) is a chronic neurodegenerative disease that is characterized by its gradual progression. At present, the cause and mechanism of AD are yet unclear, and there is no effective therapy for treating it. With development of global aging, the prevalence rate of AD is increasing. The life quality of elderly people is affected severely by AD that is ultimately life-threatening. Recently, study on treating AD with traditional Chinese medicine (TCM) has deepened. To explore the therapeutic effects of a syndrome differentiation-based TCM regime in treating patients with mild to moderate AD for improving cognition, and to evaluate the changes in brain function of AD patients observed by resting-state functional magnetic resonance imaging (fMRI) technique. Adopting the internationally recognized criteria developed by National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association, the clinical trial was conducted on 131 patients with mild to moderate AD from 5 communities and 7 social welfare institutions. Participants were accepted after informed consent was received, and laboratory tests and a head imaging study were conducted. The patients were randomly divided into Chinese medicine group (CMG) (66 cases) or Western medicine group (WMG) (65 cases). Patients in the CMG were treated monthly with Chinese medicine according to syndrome differentiation. Patients in the WMG were treated with donepezil at a dose of 5 mg once daily. The therapeutic course lasted 48 weeks. The scores of Mini-Mental State Examination (MMSE), Fuld Object-Memory Evaluation (FOM), Block Design (BD) and Digit Span (DS) were used to evaluate the cognitive function; resting-state fMRI was used for observing brain function. The questionnaires and fMRI were performed before and after treatments. The cognitive functions of the patients in the CMG and WMG were improved after treatment. MMSE score was improved significantly in

  18. Cannabis, pain, and sleep: lessons from therapeutic clinical trials of Sativex, a cannabis-based medicine.

    PubMed

    Russo, Ethan B; Guy, Geoffrey W; Robson, Philip J

    2007-08-01

    Cannabis sativa L. has been utilized for treatment of pain and sleep disorders since ancient times. This review examines modern studies on effects of Delta9-tetrahydrocannabinol (THC) and cannabidiol (CBD) on sleep. It goes on to report new information on the effects on sleep in the context of medical treatment of neuropathic pain and symptoms of multiple sclerosis, employing standardized oromucosal cannabis-based medicines containing primarily THC, CBD, or a 1 : 1 combination of the two (Sativex). Sleep-laboratory results indicate a mild activating effect of CBD, and slight residual sedation with THC-predominant extracts. Experience to date with Sativex in numerous Phase I-III studies in 2000 subjects with 1000 patient years of exposure demonstrate marked improvement in subjective sleep parameters in patients with a wide variety of pain conditions including multiple sclerosis, peripheral neuropathic pain, intractable cancer pain, and rheumatoid arthritis, with an acceptable adverse event profile. No tolerance to the benefit of Sativex on pain or sleep, nor need for dosage increases have been noted in safety extension studies of up to four years, wherein 40-50% of subjects attained good or very good sleep quality, a key source of disability in chronic pain syndromes that may contribute to patients' quality of life.

  19. How evidence-based medicine is failing due to biased trials and selective publication.

    PubMed

    Every-Palmer, Susanna; Howick, Jeremy

    2014-12-01

    Evidence-based medicine (EBM) was announced in the early 1990s as a 'new paradigm' for improving patient care. Yet there is currently little evidence that EBM has achieved its aim. Since its introduction, health care costs have increased while there remains a lack of high-quality evidence suggesting EBM has resulted in substantial population-level health gains. In this paper we suggest that EBM's potential for improving patients' health care has been thwarted by bias in the choice of hypotheses tested, manipulation of study design and selective publication. Evidence for these flaws is clearest in industry-funded studies. We argue EBM's indiscriminate acceptance of industry-generated 'evidence' is akin to letting politicians count their own votes. Given that most intervention studies are industry funded, this is a serious problem for the overall evidence base. Clinical decisions based on such evidence are likely to be misinformed, with patients given less effective, harmful or more expensive treatments. More investment in independent research is urgently required. Independent bodies, informed democratically, need to set research priorities. We also propose that evidence rating schemes are formally modified so research with conflict of interest bias is explicitly downgraded in value. © 2014 John Wiley & Sons, Ltd.

  20. COSMOS Launch Services

    NASA Astrophysics Data System (ADS)

    Kalnins, Indulis

    2002-01-01

    COSMOS-3M is a two stage launcher with liquid propellant rocket engines. Since 1960's COSMOS has launched satellites of up to 1.500kg in both circular low Earth and elliptical orbits with high inclination. The direct SSO ascent is available from Plesetsk launch site. The very high number of 759 launches and the achieved success rate of 97,4% makes this space transportation system one of the most reliable and successful launchers in the world. The German small satellite company OHB System co-operates since 1994 with the COSMOS manufacturer POLYOT, Omsk, in Russia. They have created the joint venture COSMOS International and successfully launched five German and Italian satellites in 1999 and 2000. The next commercial launches are contracted for 2002 and 2003. In 2005 -2007 COSMOS will be also used for the new German reconnaissance satellite launches. This paper provides an overview of COSMOS-3M launcher: its heritage and performance, examples of scientific and commercial primary and piggyback payload launches, the launch service organization and international cooperation. The COSMOS launch service business strategy main points are depicted. The current and future position of COSMOS in the worldwide market of launch services is outlined.

  1. The effects of two Chinese herbal medicinal formulae vs. placebo controls for treatment of allergic rhinitis: a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Allergic rhinitis is a chronic illness, affecting 10 to 40% of the worldwide population. Chinese herbal medicines, the treatment of allergic rhinitis, adopted thousands of years in ancient China, has recently raised much attention among researchers globally. This study evaluates the effects of two Chinese herbal formulae [Cure-allergic-rhinitis Syrup (CS) and Yu-ping-feng San (YS)] in treating undergraduate nursing students with allergic rhinitis over a 3-month follow-up, when compared to a placebo control group. Methods A double-blind, randomised controlled trial with repeated-measures, three-parallel-groups design was conducted in a random sample of 249 participants recruited from one university in Hong Kong. After baseline measurements, participants were randomly assigned to CS, YS, or placebo groups (n = 83 per group). The main outcomes, including symptom severity, quality of life, and body constitution, were measured with self-administered questionnaires at baseline and immediately, 1 and 3 months after the 4-week interventions. Results 240 participants completed the trial, with 9 (3.6%) drop-outs. The results of Generalised Estimating Equations test followed by pairwise contrasts tests indicated that the participants who received CS showed significantly greater reduction of symptoms (mean difference of CS vs. placebo = 26.13–34.55, P <0.0005) and improvements in quality of life (mean difference of CS vs. placebo = 12.81–16.76, P <0.001), and body constitution in ‘Qi-deficiency’, ‘Yang-deficiency’, and ‘Inherited Special’ (mean difference of CS vs. placebo = 7.05–8.12, 7.56–8.92, and 4.48–8.10, P = 0.01– < 0.0005, 0.001–0.004, and 0.01– < 0.0005, accordingly, at three post-tests). The participants who received YS also indicated significant greater improvements in symptom severity, quality of life, and a few patterns of body constitution when compared to the placebo group. However, its effects

  2. Homeopathic medicines for prevention of influenza and acute respiratory tract infections in children: blind, randomized, placebo-controlled clinical trial.

    PubMed

    Siqueira, Camila Monteiro; Homsani, Fortune; da Veiga, Venício Féo; Lyrio, Carlos; Mattos, Haroldo; Passos, Sonia Regina Lambert; Couceiro, José Nelson; Quaresma, Carla Holandino

    2016-02-01

    Influenza and its complications are common at all ages, especially in children. Vaccines and anti-influenza drugs aim to prevent it. Preventative approaches with favorable risk profiles should be considered for flu, particularly since the evidence of the efficacy of anti-viral drugs is debated. This pragmatic clinical trial was conducted in the Brazilian Public Health System in Petrópolis (BPHSP) with children aged from 1 to 5 years old. The medications used were mainly selected based on in vitro experiments (InfluBio), and in successful qualitative clinical experiences (Homeopathic Complex). Following informed parental consent, subjects were randomly distributed, in a blind manner, to three experimental groups: Homeopathic Complex, Placebo, and InfluBio. BPHSP health agents collected flu and acute respiratory infection symptomatic episodes monthly following the established protocol. The number of these episodes was registered in one year (2009-2010). Out of the 600 children recruited, 445 (74.17%) completed the study (149: Homeopathic complex; 151: Placebo; 145: InfluBio). The number of flu and acute respiratory infection symptomatic episodes detected in this clinical trial was low; however, it was different between homeopathic groups and placebo (p < 0.001). In the first year post-intervention, 46/151 (30.5%) of children in the placebo group developed 3 or more flu and acute respiratory infection episodes, while there was no episode in the group of 149 children who used Homeopathic Complex, and only 1 episode in the group of 145 (1%) children who received InfluBio. These results suggested that the use of homeopathic medicines minimized the number of flu and acute respiratory infection symptomatic episodes in children, signalizing that the homeopathic prophylactic potential should be investigated in further studies. Copyright © 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  3. Herbal medicine (Danggui Shaoyao San) for treating primary dysmenorrhea: A systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Lee, Hye Won; Jun, Ji Hee; Kil, Ki-Jung; Ko, Byong-Seob; Lee, Choong Hwan; Lee, Myeong Soo

    2016-03-01

    Danggui Shaoyao San (DSS), a traditional herbal prescription, has long been used to treat menopause-related symptoms, including dysmenorrhea. We conducted a systematic review of randomized controlled trials to evaluate the efficacy of DSS for dysmenorrhea. We searched the following electronic databases through October 2015: PubMed; EMBASE; the Cochrane Library; AMED; five Korean databases (KoreaMed, DBPIA, OASIS, RISS, and KISS); three Chinese databases (CNKI, Wan Fang Database, and VIP), and one Japanese database (CiNii). The Cochrane criteria were used to assess the risk of bias for the individual studies. All randomized clinical trials (RCTs) of DSS or modified DSS were included. Data from all articles were extracted by two independent reviewers. Meta-analysis was used to pool the data. A total of 746 potentially relevant studies were identified, and four RCTs met our inclusion criteria. All of the included RCTs had a high risk of bias across their domains. Three RCTs showed favourable effects of DSS on response rate compared with conventional medicine, and a meta-analysis showed that DSS had superior effects compared to analgesics (RR: 1.31, 95%CI, 1.06-1.63, I(2)=73%). One RCT showed a beneficial effect of DSS on pain compared with placebo control. Our systematic review and meta-analysis provided suggestive evidence of the superiority of DSS over analgesics or placebo for dysmenorrhea. The quality of evidence for this finding was low to moderate because of a high risk of bias. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  4. A controlled trial of an advanced access appointment system in a residency family medicine center.

    PubMed

    Belardi, Francis G; Weir, Sam; Craig, Francis W

    2004-05-01

    The implementation of advanced access appointment systems has improved continuity of care, patient and physician satisfaction, physician productivity, and average physician panel size in private practice and group-model HMO settings. This study's purpose was to document the patient care benefits, practice management benefits, and educational outcomes from the controlled implementation of an advanced access appointment system in a residency family medicine center. Two faculty-resident teams were created. One team adopted the advanced access system while the other team continued using a traditional access system. Outcome measures included length of time needed to obtain an appointment (days to third available appointment), continuity (percentage of visits with the patient's designated provider), no-show rates, productivity, visits lost to outside providers, panel sizes, and patient satisfaction. Outcomes were measured at baseline and quarterly for 1 year after initial implementation. After implementation, the "days to third available appointment" for the advanced access group was 5 days, compared to 21 days for the traditional access group. A significant improvement in continuity (ie, a match between the primary care physician and patient) for the advanced access team was found. Comparison of no-show rates between the advanced access and traditional access teams revealed significant between-subjects effect, but controlling for within-subject variation using repeated measures ANOVA eliminated this effect. Advanced access residents increased their continuity above 50% while increasing provider satisfaction with office practice and scope of practice. Faculty and residents can successfully use advanced access. Advanced access can enhance residency education by reducing appointment delays and significantly increasing the patient-primary care physician match.

  5. Two strategies to intensify evidence-based medicine education of undergraduate students: a randomised controlled trial.

    PubMed

    Cheng, Hao Min; Guo, Fei Ran; Hsu, Teh Fu; Chuang, Shao Yuan; Yen, Hung Tsang; Lee, Fa Yauh; Yang, Ying Ying; Chen, Te Li; Lee, Wen Shin; Chuang, Chiao Lin; Chen, Chen Huan; Ho, Tone

    2012-01-01

    Undergraduate evidence-based practice (EBP) is usually taught through standalone courses and workshops away from clinical practice. This study compared the effects of 2 clinically integrated educational strategies on final year medical students. Final year medical students rotating to the general medicine service for a 2-week internship were randomly assigned to participate in a weekly EBP-structured case conference focusing on students' primary care patients (Group A, n = 47), or to receive a weekly didactic lecture about EBP (Group B, n = 47). The teaching effects of these 2 interventions were evaluated by a validated instrument for assessment of EBP related knowledge (EBP-K), attitude (EBP-A), personal application (EBP-P), and anticipated future use (EBP-F) on the first and last days of rotation. All scores improved significantly after the 2-week EBM-teaching for both groups. When compared to Group B, students in Group A had significantly higher post-intervention scores of EBP-K (21.2 ± 3.5 vs 19.0 ± 4.6; ie. 57.8 ± 72.9% vs 29.1 ± 39.1%; P <0.01) and EBP-P (18.7 ± 4.3 vs 15.3 ± 3.9; ie. 28.5 ± 25.5 % vs 14.1 ± 18.7 %; P <0.001). In contrast, the scores of EBP-A and EBP-F were similar between the 2 groups. Structured case conference, when compared to the didactic lectures, significantly improved EBP-K and EBP-P for final year medical students.

  6. Complementary therapies for labour and birth study: a randomised controlled trial of antenatal integrative medicine for pain management in labour.

    PubMed

    Levett, Kate M; Smith, C A; Bensoussan, A; Dahlen, H G

    2016-07-12

    To evaluate the effect of an antenatal integrative medicine education programme in addition to usual care for nulliparous women on intrapartum epidural use. Open-label, assessor blind, randomised controlled trial. 2 public hospitals in Sydney, Australia. 176 nulliparous women with low-risk pregnancies, attending hospital-based antenatal clinics. The Complementary Therapies for Labour and Birth protocol, based on the She Births and acupressure for labour and birth courses, incorporated 6 evidence-based complementary medicine techniques: acupressure, visualisation and relaxation, breathing, massage, yoga techniques, and facilitated partner support. Randomisation occurred at 24-36 weeks' gestation, and participants attended a 2-day antenatal education programme plus standard care, or standard care alone. Rate of analgesic epidural use. Secondary: onset of labour, augmentation, mode of birth, newborn outcomes. There was a significant difference in epidural use between the 2 groups: study group (23.9%) standard care (68.7%; risk ratio (RR) 0.37 (95% CI 0.25 to 0.55), p≤0.001). The study group participants reported a reduced rate of augmentation (RR=0.54 (95% CI 0.38 to 0.77), p<0.0001); caesarean section (RR=0.52 (95% CI 0.31 to 0.87), p=0.017); length of second stage (mean difference=-0.32 (95% CI -0.64 to 0.002), p=0.05); any perineal trauma (0.88 (95% CI 0.78 to 0.98), p=0.02) and resuscitation of the newborn (RR=0.47 (95% CI 0.25 to 0.87), p≤0.015). There were no statistically significant differences found in spontaneous onset of labour, pethidine use, rate of postpartum haemorrhage, major perineal trauma (third and fourth degree tears/episiotomy), or admission to special care nursery/neonatal intensive care unit (p=0.25). The Complementary Therapies for Labour and Birth study protocol significantly reduced epidural use and caesarean section. This study provides evidence for integrative medicine as an effective adjunct to antenatal education, and contributes

  7. Herbal medicine (Shaofu Zhuyu decoction) for treating primary dysmenorrhea: A systematic review of randomized clinical trials.

    PubMed

    Lee, Hoyoung; Choi, Tae-Young; Myung, Chang-Seon; Lee, Ju Ah; Lee, Myeong Soo

    2016-04-01

    Shaofu Zhuyu decoction (SFZY) or Sobokchugeo-tang, a traditional herbal formula, is used as a treatment for primary dysmenorrhea. We searched four English, seven Korean, three Chinese, and one Japanese database from inception through January 2016 without a language restriction. All randomized controlled trials (RCTs) of SFZY or modified SFZY (MSFZY) were included. Data extraction and risk of bias assessments were performed by two independent reviewers. A total of 51 potentially relevant studies were identified, and 9 RCTs met our inclusion criteria. Seven RCTs tested the effects of SFZY or modified SFZY in treating dysmenorrhea. Three RCTs showed superior effects of (M)SFZY on the response rate, while the other three RCTs failed to do so (n=531, RR: 1.17, 95% CI: 1.09 to 1.26, P<0.0001, I(2)=0%). Three RCTs showed favorable effects of MSFZY for pain reduction compared with conventional drugs (n=340, SMD: -1.39, 95% CI: -2.23 to -0.55, P=0.01). Two RCTs examined the effects of modified SFZY plus conventional drugs and conventional drugs alone. The meta-analysis showed favorable effects of MSFZY (n=206; RR, 1.12; 95% CI 1.08 to 1.36; P=0.0009, I(2)=0%). Our systemic review and meta-analysis provide suggestive evidence of the superiority of SFZY over conventional drugs for treating primary dysmenorrhea. However, the level of evidence is low because of a high risk of bias. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  8. Randomised clinical trial of snus versus medicinal nicotine among smokers interested in product switching

    PubMed Central

    Hatsukami, Dorothy K; Severson, Herbert; Anderson, Amanda; Vogel, Rachael Isaksson; Jensen, Joni; Broadbent, Berry; Murphy, Sharon E; Carmella, Steven; Hecht, Stephen S

    2016-01-01

    Background An essential component of evaluating potential modified risk tobacco products is to determine how consumers use the product and resulting effects on biomarkers of toxicant exposure. Study design Cigarette smokers (n=391) recruited in Minnesota and Oregon were randomised to either snus or 4 mg nicotine gum for 12 weeks. Participants were instructed to completely switch from cigarettes to these products. Urine samples were collected to analyse for carcinogenic tobacco-specific nitrosamine metabolites (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and N′-nitrosonornicotine and their glucuronides) and nicotine metabolites (total cotinine and nicotine equivalents) levels. Results Of the 391 participants randomised, 52.9% were male, the mean±SD age was 43.9±12.5 years, baseline number of cigarettes/day was 18.0±6.5 and Fagerstrom Test for Nicotine Dependence score was 5.1±2.0. The mean±SD number of snus pouches used/week at week 6 prior to tapering was 39.1±24.0 and nicotine gum pieces used was 37.6±26.3. Dual use of cigarettes and these products were observed in 52.9% and 58.2% of those assigned to snus and nicotine gum, respectively, at week 12. The end of treatment biochemically verified (carbon monoxide, CO <6 ppm) 7-day avoidance of cigarettes was 21.9% in the snus group and 24.6% in the nicotine gum group. Toxicant exposure in the nicotine gum group was significantly less when compared to snus. Conclusions Snus performed similarly to nicotine gum in cigarette smokers who were interested in completely switching to these products, but was associated with less satisfaction and greater toxicant exposure than nicotine gum. Trial registration number NCT: 00710034. PMID:25991608

  9. Pediatric Hodgkin lymphoma– biomarkers, drugs, and clinical trials for translational science and medicine

    PubMed Central

    Nagpal, Poonam; Akl, Mohamed R.; Ayoub, Nehad M.; Tomiyama, Tatsunari; Cousins, Tasheka; Tai, Betty; Carroll, Nicole; Nyrenda, Themba; Bhattacharyya, Pritish; Harris, Michael B.; Goy, Andre; Pecora, Andrew; Suh, K. Stephen

    2016-01-01

    Hodgkin lymphoma (HL) is a lymphoid malignancy that is typically derived from germinal-center B cells. EBV infection, mutations in NF-κB pathway genes, and genetic susceptibility are known risk factors for developing HL. CD30 and NF-κB have been identified as potential biomarkers in pediatric HL patients, and these molecules may represent therapeutic targets. Although current risk adapted and response based treatment approaches yield overall survival rates of >95%, treatment of relapse or refractory patients remains challenging. Targeted HL therapy with the antibody-drug conjugate Brentuximab vedotin (Bv) has proven to be superior to conventional salvage chemotherapy and clinical trials are being conducted to incorporate Bv into frontline therapy that substitutes Bv for alkylating agents to minimize secondary malignancies. The appearance of secondary malignancies has been a concern in pediatric HL, as these patients are at highest risk among all childhood cancer survivors. The risk of developing secondary leukemia following childhood HL treatment is 10.4 to 174.8 times greater than the risk in the general pediatric population and the prognosis is significantly poorer than the other hematological malignancies with a mortality rate of nearly 100%. Therefore, identifying clinically valuable biomarkers is of utmost importance to stratify and select patients who may or may not need intensive regimens to maintain optimal balance between maximal survival rates and averting late effects. Here we discuss epidemiology, risk factors, staging, molecular and genetic prognostic biomarkers, treatment for low and high-risk patients, and the late occurrence of secondary malignancies in pediatric HL. PMID:27563824

  10. Antares Rocket Test Launch

    NASA Image and Video Library

    2013-04-21

    The Orbital Sciences Corporation Antares rocket is seen as it launches from Pad-0A of the Mid-Atlantic Regional Spaceport (MARS) at the NASA Wallops Flight Facility in Virginia, Sunday, April 21, 2013. The test launch marked the first flight of Antares and the first rocket launch from Pad-0A. The Antares rocket delivered the equivalent mass of a spacecraft, a so-called mass simulated payload, into Earth's orbit. Photo Credit: (NASA/Bill Ingalls)

  11. STS-135 Atlantis Launch

    NASA Image and Video Library

    2011-07-07

    NASA Administrator Charles Bolden speaks to visitors at the NASA Kennedy Space Center Banana Creek viewing site prior to going to the Launch Control Center (LCC) for the planned launch of the space shuttle Atlantis from pad 39A on Friday, July 8, 2011, in Cape Canaveral, Fla. The launch of Atlantis, STS-135, is the final flight of the shuttle program, a 12-day mission to the International Space Station. Photo Credit: (NASA/Bill Ingalls)

  12. Launch the Litening Pod!

    DTIC Science & Technology

    2008-02-19

    Launch the LITENING Pod ! EWS Contemporary Issue Paper Submitted by Captain Fausett, Brian M. to Major G.A. Thiele, CG 2 19...TITLE AND SUBTITLE Launch the Litening Pod ! 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e...ABSTRACT unclassified c. THIS PAGE unclassified Standard Form 298 (Rev. 8-98) Prescribed by ANSI Std Z39-18 2 “Launch the LITENING pod

  13. MAVEN Atlas V Launch

    NASA Image and Video Library

    2013-11-18

    The United Launch Alliance Atlas V rocket with NASA’s Mars Atmosphere and Volatile Evolution (MAVEN) spacecraft launches from the Cape Canaveral Air Force Station Space Launch Complex 41, Monday, Nov. 18, 2013, Cape Canaveral, Florida. NASA’s Mars-bound spacecraft, the Mars Atmosphere and Volatile EvolutionN, or MAVEN, is the first spacecraft devoted to exploring and understanding the Martian upper atmosphere. Photo Credit: (NASA/Bill Ingalls)

  14. LAUNCH - STS-4 - KSC

    NASA Image and Video Library

    1982-07-06

    S82-33288 (27 June 1982) --- This horizontal view of the space shuttle Columbia captures the flight of water birds disturbed by the activity at launch Pad 39A. Launch occurred at 10:59:59 a.m. (EDT), June 27, 1982. Astronauts Thomas K. Mattingly II and Henry W. Hartsfield Jr. are aboard for NASA's final orbital flight test before launching into a new space era with the first operational flight planned for fall of this year. Photo credit: NASA

  15. MAVEN Atlas V Launch

    NASA Image and Video Library

    2013-11-18

    The United Launch Alliance Atlas V rocket with NASA’s Mars Atmosphere and Volatile EvolutioN (MAVEN) spacecraft launches from the Cape Canaveral Air Force Station Space Launch Complex 41, Monday, Nov. 18, 2013, Cape Canaveral, Florida. NASA’s Mars-bound spacecraft, the Mars Atmosphere and Volatile EvolutioN, or MAVEN, is the first spacecraft devoted to exploring and understanding the Martian upper atmosphere. Photo Credit: (NASA/Bill Ingalls)

  16. Expedition 27 Launch

    NASA Image and Video Library

    2010-04-01

    The Soyuz TMA-21 launches from the Baikonur Cosmodrome in Kazakhstan on Tuesday, April 5, 2011 carrying Expedition 27 Soyuz Commander Alexander Samokutyaev, NASA Flight Engineer Ron Garan and Russian Flight Engineer Andrey Borisenko to the International Space Station. The Soyuz, which has been dubbed "Gagarin", is launching one week shy of the 50th anniversary of the launch of Yuri Gagarin from the same launch pad in Baikonur on April 12, 1961 to become the first human to fly in space. Photo Credit: (NASA/Victor Zelentsov)

  17. Expedition 27 Launch

    NASA Image and Video Library

    2011-04-04

    The Soyuz TMA-21 launches from the Baikonur Cosmodrome in Kazakhstan on Tuesday, April 5, 2011 carrying Expedition 27 Soyuz Commander Alexander Samokutyaev, NASA Flight Engineer Ron Garan and Russian Flight Engineer Andrey Borisenko to the International Space Station. The Soyuz, which has been dubbed "Gagarin", is launching one week shy of the 50th anniversary of the launch of Yuri Gagarin from the same launch pad in Baikonur on April 12, 1961 to become the first human to fly in space. Photo Credit: (NASA/Carla Cioffi)

  18. Launch Services Safety Overview

    NASA Technical Reports Server (NTRS)

    Loftin, Charles E.

    2008-01-01

    NASA/KSC Launch Services Division Safety (SA-D) services include: (1) Assessing the safety of the launch vehicle (2) Assessing the safety of NASA ELV spacecraft (S/C) / launch vehicle (LV) interfaces (3) Assessing the safety of spacecraft processing to ensure resource protection of: - KSC facilities - KSC VAFB facilities - KSC controlled property - Other NASA assets (4) NASA personnel safety (5) Interfacing with payload organizations to review spacecraft for adequate safety implementation and compliance for integrated activities (6) Assisting in the integration of safety activities between the payload, launch vehicle, and processing facilities

  19. Antares Rocket Test Launch

    NASA Image and Video Library

    2013-04-21

    NASA Administrator Charles Bolden congratulates the Orbital Sciences Corporation launch team and management in the Range Control Center at the NASA Wallops Flight Facility after the successful launch of the Orbital Sciences Antares rocket from the Mid-Atlantic Regional Spaceport (MARS) in Virginia, Sunday, April 21, 2013. The test launch marked the first flight of Antares and the first rocket launch from Pad-0A. The Antares rocket delivered the equivalent mass of a spacecraft, a so-called mass simulated payload, into Earth's orbit. Photo Credit: (NASA/Bill Ingalls)

  20. GPM: Waiting for Launch

    NASA Image and Video Library

    The Global Precipitation Measurement mission's Core Observatory is poised for launch from the Japan Aerospace Exploration Agency's Tanegashima Space Center, scheduled for the afternoon of Feb. 27, ...

  1. Kestrel balloon launch system

    SciTech Connect

    Newman, M.J.

    1991-10-01

    Kestrel is a high-altitude, Helium-gas-filled-balloon system used to launch scientific payloads in winds up to 20 knots, from small platforms or ships, anywhere over land or water, with a minimal crew and be able to hold in standby conditions. Its major components consist of two balloons (a tow balloon and a main balloon), the main deployment system, helium measurement system, a parachute recovery unit, and the scientific payload package. The main scope of the launch system was to eliminate the problems of being dependent of launching on long airfield runways, low wind conditions, and long launch preparation time. These objectives were clearly met with Kestrel 3.

  2. Trials of large group teaching in Malaysian private universities: a cross sectional study of teaching medicine and other disciplines.

    PubMed

    Thomas, Susan; Subramaniam, Shamini; Abraham, Mathew; Too, Laysan; Beh, Loosee

    2011-09-09

    This is a pilot cross sectional study using both quantitative and qualitative approach towards tutors teaching large classes in private universities in the Klang Valley (comprising Kuala Lumpur, its suburbs, adjoining towns in the State of Selangor) and the State of Negeri Sembilan, Malaysia. The general aim of this study is to determine the difficulties faced by tutors when teaching large group of students and to outline appropriate recommendations in overcoming them. Thirty-two academics from six private universities from different faculties such as Medical Sciences, Business, Information Technology, and Engineering disciplines participated in this study. SPSS software was used to analyse the data. The results in general indicate that the conventional instructor-student approach has its shortcoming and requires changes. Interestingly, tutors from Medicine and IT less often faced difficulties and had positive experience in teaching large group of students. However several suggestions were proposed to overcome these difficulties ranging from breaking into smaller classes, adopting innovative teaching, use of interactive learning methods incorporating interactive assessment and creative technology which enhanced students learning. Furthermore the study provides insights on the trials of large group teaching which are clearly identified to help tutors realise its impact on teaching. The suggestions to overcome these difficulties and to maximize student learning can serve as a guideline for tutors who face these challenges.

  3. A Randomized Controlled Trial of a CPR Decision Support Video for Patients Admitted to the General Medicine Service.

    PubMed

    Merino, Aimee M; Greiner, Ryan; Hartwig, Kristopher

    2017-09-01

    Patient preferences regarding cardiopulmonary resuscitation (CPR) are important, especially during hospitalization when a patient's health is changing. Yet many patients are not adequately informed or involved in the decision-making process. We examined the effect of an informational video about CPR on hospitalized patients' code status choices. This was a prospective, randomized trial conducted at the Minneapolis Veterans Affairs Health Care System in Minnesota. We enrolled 119 patients, hospitalized on the general medicine service, and at least 65 years old. The majority were men (97%) with a mean age of 75. A video described code status choices: full code (CPR and intubation if required), do not resuscitate (DNR), and do not resuscitate/do not intubate (DNR/DNI). Participants were randomized to watch the video (n = 59) or usual care (n = 60). The primary outcome was participants' code status preferences. Secondary outcomes included a questionnaire designed to evaluate participants' trust in their healthcare team and knowledge and perceptions about CPR. Participants who viewed the video were less likely to choose full code (37%) compared to participants in the usual care group (71%) and more likely to choose DNR/DNI (56% in the video group vs. 17% in the control group) ( < 0.00001). We did not see a difference in trust in their healthcare team or knowledge and perceptions about CPR as assessed by our questionnaire. Hospitalized patients who watched a video about CPR and code status choices were less likely to choose full code and more likely to choose DNR/DNI.

  4. Trials of large group teaching in Malaysian private universities: a cross sectional study of teaching medicine and other disciplines

    PubMed Central

    2011-01-01

    Background This is a pilot cross sectional study using both quantitative and qualitative approach towards tutors teaching large classes in private universities in the Klang Valley (comprising Kuala Lumpur, its suburbs, adjoining towns in the State of Selangor) and the State of Negeri Sembilan, Malaysia. The general aim of this study is to determine the difficulties faced by tutors when teaching large group of students and to outline appropriate recommendations in overcoming them. Findings Thirty-two academics from six private universities from different faculties such as Medical Sciences, Business, Information Technology, and Engineering disciplines participated in this study. SPSS software was used to analyse the data. The results in general indicate that the conventional instructor-student approach has its shortcoming and requires changes. Interestingly, tutors from Medicine and IT less often faced difficulties and had positive experience in teaching large group of students. Conclusion However several suggestions were proposed to overcome these difficulties ranging from breaking into smaller classes, adopting innovative teaching, use of interactive learning methods incorporating interactive assessment and creative technology which enhanced students learning. Furthermore the study provides insights on the trials of large group teaching which are clearly identified to help tutors realise its impact on teaching. The suggestions to overcome these difficulties and to maximize student learning can serve as a guideline for tutors who face these challenges. PMID:21902839

  5. A randomized, controlled trial comparing traditional herbal medicine and neuraminidase inhibitors in the treatment of seasonal influenza.

    PubMed

    Nabeshima, Shigeki; Kashiwagi, Kenichiro; Ajisaka, Kazuhiko; Masui, Shinta; Takeoka, Hiroaki; Ikematsu, Hideyuki; Kashiwagi, Seizaburo

    2012-08-01

    The herbal medicine, maoto, has been traditionally prescribed to patients with influenza in Japan. To better understand the efficacy of maoto for the treatment of influenza, a randomized trial was conducted for comparison with oseltamivir or zanamivir. Adult patients with influenza symptoms, including fever, positive for quick diagnostic kit for influenza within 48 h of fever onset were assessed for enrollment. The data of 28 patients randomly assigned to maoto (n = 10), oseltamivir (n = 8), or zanamivir (n = 10) were analyzed for the duration of fever (>37.5°C) and total symptom score from symptom cards recorded by the patient. Viral isolation and serum cytokine measurements were also done on days 1, 3, and 5. Maoto granules, a commercial medical dosage form, are made from four plants: Ephedra Herb, Apricot Kernel, Cinnamon Bark, and Glycyrrhiza Root. Median durations of fever of patients assigned maoto, oseltamivir, or zanamivir were 29, 46, or 27 h, respectively, significantly different for maoto and oseltamivir. No significant between-group differences were found in total symptom score among three groups. Viral persistent rates and serum cytokine levels (IFN-α, IL-6, IL-8, IL-10, and TNF-α) during the study period showed no differences among three groups. The administration of oral maoto granules to healthy adults with seasonal influenza was well tolerated and associated with equivalent clinical and virological efficacy to neuraminidase inhibitors.

  6. Teaching evidence-based medicine literature searching skills to medical students during the clinical years: a randomized controlled trial.

    PubMed

    Ilic, Dragan; Tepper, Katrina; Misso, Marie

    2012-07-01

    Constructing an answerable question and effectively searching the medical literature are key steps in practicing evidence-based medicine (EBM). This study aimed to identify the effectiveness of delivering a single workshop in EBM literature searching skills to medical students entering their first clinical years of study. A randomized controlled trial was conducted with third-year undergraduate medical students. Participants were randomized to participate in a formal workshop in EBM literature searching skills, with EBM literature searching skills and perceived competency in EBM measured at one-week post-intervention via the Fresno tool and Clinical Effectiveness and Evidence-Based Practice Questionnaire. A total of 121 participants were enrolled in the study, with 97 followed-up post-intervention. There was no statistical mean difference in EBM literature searching skills between the 2 groups (mean difference = 0.007 (P = 0.99)). Students attending the EBM workshop were significantly more confident in their ability to construct clinical questions and had greater perceived awareness of information resources. A single EBM workshop did not result in statistically significant changes in literature searching skills. Teaching and reinforcing EBM literature searching skills during both preclinical and clinical years may result in increased student confidence, which may facilitate student use of EBM skills as future clinicians.

  7. The effectiveness of a clinically integrated e-learning course in evidence-based medicine: a cluster randomised controlled trial.

    PubMed

    Kulier, Regina; Coppus, Sjors F P J; Zamora, Javier; Hadley, Julie; Malick, Sadia; Das, Kausik; Weinbrenner, Susanne; Meyerrose, Berrit; Decsi, Tamas; Horvath, Andrea R; Nagy, Eva; Emparanza, Jose I; Arvanitis, Theodoros N; Burls, Amanda; Cabello, Juan B; Kaczor, Marcin; Zanrei, Gianni; Pierer, Karen; Stawiarz, Katarzyna; Kunz, Regina; Mol, Ben W J; Khan, Khalid S

    2009-05-12

    To evaluate the educational effects of a clinically integrated e-learning course for teaching basic evidence-based medicine (EBM) among postgraduates compared to a traditional lecture-based course of equivalent content. We conducted a cluster randomised controlled trial in the Netherlands and the UK involving postgraduate trainees in six obstetrics and gynaecology departments. Outcomes (knowledge gain and change in attitude towards EBM) were compared between the clinically integrated e-learning course (intervention) and the traditional lecture based course (control). We measured change from pre- to post-intervention scores using a validated questionnaire assessing knowledge (primary outcome) and attitudes (secondary outcome). There were six clusters involving teaching of 61 postgraduate trainees (28 in the intervention and 33 in the control group). The intervention group achieved slightly higher scores for knowledge gain compared to the control, but these results were not statistically significant (difference in knowledge gain: 3.5 points, 95% CI -2.7 to 9.8, p = 0.27). The attitudinal changes were similar for both groups. A clinically integrated e-learning course was at least as effective as a traditional lecture based course and was well accepted. Being less costly than traditional teaching and allowing for more independent learning through materials that can be easily updated, there is a place for incorporating e-learning into postgraduate EBM curricula that offer on-the-job training for just-in-time learning. ACTRN12609000022268.

  8. Teaching evidence-based medicine literature searching skills to medical students during the clinical years: a randomized controlled trial

    PubMed Central

    Tepper, Katrina; Misso, Marie

    2012-01-01

    Objectives: Constructing an answerable question and effectively searching the medical literature are key steps in practicing evidence-based medicine (EBM). This study aimed to identify the effectiveness of delivering a single workshop in EBM literature searching skills to medical students entering their first clinical years of study. Methods: A randomized controlled trial was conducted with third-year undergraduate medical students. Participants were randomized to participate in a formal workshop in EBM literature searching skills, with EBM literature searching skills and perceived competency in EBM measured at one-week post-intervention via the Fresno tool and Clinical Effectiveness and Evidence-Based Practice Questionnaire. Results: A total of 121 participants were enrolled in the study, with 97 followed-up post-intervention. There was no statistical mean difference in EBM literature searching skills between the 2 groups (mean difference = 0.007 (P = 0.99)). Students attending the EBM workshop were significantly more confident in their ability to construct clinical questions and had greater perceived awareness of information resources. Conclusions: A single EBM workshop did not result in statistically significant changes in literature searching skills. Teaching and reinforcing EBM literature searching skills during both preclinical and clinical years may result in increased student confidence, which may facilitate student use of EBM skills as future clinicians. PMID:22879808

  9. Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial.

    PubMed

    Zhang, Zhe; Zhang, Fan; Wang, Yang; Du, Yi; Zhang, Huiyong; Kong, Dezhao; Liu, Yue; Yang, Guanlin

    2014-10-30

    Stable angina pectoris is experienced as trans-sternal or retro-sternal pressure or pain that may radiate to the left arm, neck or back. Although available evidence relating to its effectiveness and mechanism are weak, traditional Chinese medicine is used as an alternative therapy for stable angina pectoris. We report a protocol of a randomized controlled trial using traditional Chinese medicine to investigate the effectiveness, mechanism and safety for patients with stable angina pectoris. This is a north-east Chinese, multi-center, multi-blinded, placebo-controlled and superiority randomized trail. A total of 240 patients with stable angina pectoris will be randomly assigned to three groups: two treatment groups and a control group. The treatment groups will receive Chinese herbal medicine consisting of Yi-Qi-Jian-Pi and Qu-Tan-Hua-Zhuo granule and Yi-Qi-Jian-Pi and Qu-Tan-Hua-Yu granule, respectively, and conventional medicine. The control group will receive placebo medicine in addition to conventional medicine. All 3 groups will undergo a 12-week treatment and 2-week follow-up. Four visits in sum will be scheduled for each subject: 1 visit each in week 0, week 4, week 12 and week 14. The primary outcomes include: the frequency of angina pectoris attack; the dosage of nitroglycerin; body limited dimension of Seattle Angina Questionnaire. The secondary outcomes include: except for the body limited dimension of SAQ, traditional Chinese medicine pattern questionnaire and so on. Therapeutic mechanism outcomes, safety outcomes and endpoint outcomes will be also assessed. The primary aim of this trial is to develop a standard protocol to utilize high-quality EBM evidence for assessing the effectiveness and safety of SAP via TCM pattern differentiation as well as exploring the efficacy mechanism and regulation with the molecular biology and systems biology. ChiCTR-TRC-13003608, registered 18 June 2013.

  10. Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England

    PubMed Central

    2013-01-01

    Background Medication non-adherence is considered an important cause of morbidity and mortality in primary care. This study aims to determine the effectiveness, cost effectiveness and acceptability of a complex intervention delivered by community pharmacists, the New Medicine Service (NMS), compared with current practice in reducing non-adherence to, and problems with, newly prescribed medicines for chronic conditions. Methods/design Research subject group: patients aged 14 years and above presenting in a community pharmacy for a newly prescribed medicine for asthma/chronic obstructive pulmonary disease (COPD); hypertension; type 2 diabetes or anticoagulant/antiplatelet agents in two geographical regions in England. Design: parallel group patient-level pragmatic randomized controlled trial. Interventions: patients randomized to either: (i) current practice; or (ii) NMS intervention comprising pharmacist-delivered support for a newly prescribed medicine. Primary outcomes: proportion of adherent patients at six, ten and 26 weeks from the date of presenting their prescriptions at the pharmacy; cost effectiveness of the intervention versus current practice at 10 weeks and 26 weeks; in-depth qualitative understanding of the operationalization of NMS in pharmacies. Secondary outcomes: impact of NMS on: patients’ understanding of their medicines, pharmacovigilance, interprofessional and patient-professional relationships and experiences of service users and stakeholders. Economic analysis: Trial-based economic analysis (cost per extra adherent patient) and long-term modeling of costs and health effects (cost per quality-adjusted-life-year) will be conducted from the perspective of National Health Service (NHS) England, comparing NMS with current practice. Qualitative analysis: a qualitative study of NMS implementation in different community settings, how organizational influences affect NMS delivery, patterns of NMS consultations and experiences of professionals and

  11. Expedition 24 Launch Day

    NASA Image and Video Library

    2010-06-14

    Expedition 24 NASA Flight Engineer Shannon Walker has her Russian Sokol suit prepared for launch by technicians at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Tuesday, June 15, 2010. Walker, Soyuz Commander Fyodor Yurchikhin and Flight Engineer Doug Wheelock launched in their Soyuz TMA-19 rocket from the Baikonur Cosmodrome in Kazakhstan on Wednesday, June 16, 2010. (Photo Credit: NASA/Carla Cioffi)

  12. Expedition 24 Launch Day

    NASA Image and Video Library

    2010-06-14

    Expedition 24 NASA Flight Engineer Doug Wheelock, center, has his Russian Sokol suit prepared for launch by a technician at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Tuesday, June 15, 2010. Wheelock, Soyuz Commander Fyodor Yurchikhin and Flight Engineer Shannon Walker launched in their Soyuz TMA-19 rocket from the Baikonur Cosmodrome in Kazakhstan on Wednesday, June 16, 2010. (Photo Credit: NASA/Carla Cioffi)

  13. Expedition 24 Launch Day

    NASA Image and Video Library

    2010-06-14

    Expedition 24 NASA Flight Engineer Doug Wheelock has his Russian Sokol suit prepared for launch by a technician at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Tuesday, June 15, 2010. Wheelock, Soyuz Commander Fyodor Yurchikhin and Flight Engineer Shannon Walker launched in their Soyuz TMA-19 rocket from the Baikonur Cosmodrome in Kazakhstan on Wednesday, June 16, 2010. (Photo Credit: NASA/Carla Cioffi)

  14. Saturn IB Launch

    NASA Technical Reports Server (NTRS)

    1973-01-01

    The Saturn IB launch vehicle lifting off from Launch Complex 39B at 9:01 a.m. EST. The Skylab 4 astronauts Gerald P. Carr, Dr. Edward G. Gibson, and William R. Pogue, were onboard for the third and final mission to the orbiting space station.

  15. Saturn IB Launch Summary

    NASA Technical Reports Server (NTRS)

    1973-01-01

    This chart provides a launch summary of the Saturn IB launch vehicle as of 1973. Developed by the Marshall Space Flight Center (MSFC) as an interim vehicle in MSFC's 'building block' approach to the Saturn rocket development, the Saturn IB utilized Saturn I technology to further develop and refine the larger boosters and the Apollo spacecraft capabilities required for the marned lunar missions.

  16. Expedition 8 Launch Briefing

    NASA Image and Video Library

    2003-10-15

    Expedition 8 Soyuz Commander and Flight Engineer Alexander Kaleri and European Space Agency astronaut Pedro Duque of Spain are briefed on launch procedures from a Russian trainer at their crew quarters in Baikonur, Kazakhstan, Wednesday, Oct. 15, 2003 as they prepare for launch Oct. 18 in a Soyuz TMA-3 vehicle to the International Space Station. Photo Credit (NASA/Bill Ingalls)

  17. Launch Collision Probability

    NASA Technical Reports Server (NTRS)

    Bollenbacher, Gary; Guptill, James D.

    1999-01-01

    This report analyzes the probability of a launch vehicle colliding with one of the nearly 10,000 tracked objects orbiting the Earth, given that an object on a near-collision course with the launch vehicle has been identified. Knowledge of the probability of collision throughout the launch window can be used to avoid launching at times when the probability of collision is unacceptably high. The analysis in this report assumes that the positions of the orbiting objects and the launch vehicle can be predicted as a function of time and therefore that any tracked object which comes close to the launch vehicle can be identified. The analysis further assumes that the position uncertainty of the launch vehicle and the approaching space object can be described with position covariance matrices. With these and some additional simplifying assumptions, a closed-form solution is developed using two approaches. The solution shows that the probability of collision is a function of position uncertainties, the size of the two potentially colliding objects, and the nominal separation distance at the point of closest approach. ne impact of the simplifying assumptions on the accuracy of the final result is assessed and the application of the results to the Cassini mission, launched in October 1997, is described. Other factors that affect the probability of collision are also discussed. Finally, the report offers alternative approaches that can be used to evaluate the probability of collision.

  18. STS-135 Atlantis Launch

    NASA Image and Video Library

    2011-07-08

    Space shuttle Atlantis is seen as it launches from pad 39A on Friday, July 8, 2011, at NASA's Kennedy Space Center in Cape Canaveral, Fla. The launch of Atlantis, STS-135, is the final flight of the shuttle program, a 12-day mission to the International Space Station. Photo Credit: (NASA/Bill Ingalls)

  19. Oral administration of Chinese herbal medicine during gestation period for preventing hemolytic disease of the newborn due to ABO incompatibility: A systematic review of randomized controlled trials

    PubMed Central

    Cao, Huijuan; Wu, Ruohan; Han, Mei; Caldwell, Patrina Ha Yuen

    2017-01-01

    Background About 85.3% of hemolytic disease of the newborn (HDN) is caused by maternal-fetal ABO blood group incompatibility. However, there is currently no recommended “best” therapy for ABO incompatibility during pregnancy. Objectives To systematically assess the safety and effectiveness of oral Chinese herbal medicine (CHM) for preventing HDN due to ABO incompatibility. Methods The protocol of this review was registered on the PROSPERO website (No. CRD42016038637).Six databases were searched from inception to April 2016. Randomized controlled trials (RCTs) of CHM for maternal-fetal ABO incompatibility were included. The primary outcome was incidence of HDN. The Cochrane risk of bias tool was used to assess the methodological quality of included trials. Risk ratios (RR) and mean differences with 95% confidence interval were used as effect measures. Meta-analyses using Revman 5.3 software were conducted if there were sufficient trials without obvious clinical or statistical heterogeneity available. Results Totally 28 RCTs involving3413 women were included in the review. The majority of the trials had unclear or high risk of bias. Our study found that the rate of HDN and the incidence of neonatal jaundice might be 70% lower in the herbal medicine group compared with the usual care group (RR from 0.25 to 0.30).After treatment with herbal medicine, women were twice as likely to have antibody titers lower than 1:64 compared with women who received usual care(RR from 2.15 to 3.14) and the umbilical cord blood bilirubin level in the herbal medicine group was 4umol/L lower than in those receiving usual care. There was no difference in Apgar scores or birthweights between the two groups. Conclusions This review found very low-quality evidence that CHM prevented HDN caused by maternal-fetal ABO incompatibility. No firm conclusions can be drawn regarding the effectiveness or safety of CHM for this condition. PMID:28719639

  20. Reporting quality of randomized controlled trial abstracts published in leading laser medicine journals: an assessment using the CONSORT for abstracts guidelines.

    PubMed

    Jin, Lu; Hua, Fang; Cao, Qiang

    2016-11-01

    The objectives of this study were to assess the reporting quality of randomized controlled trial (RCT) abstracts published in leading laser medicine journals and investigate the association between potential predictors and reporting quality. The official online archives of four leading laser medicine journals were hand-searched to identify RCTs published in 2014 and 2015. A reporting quality assessment was carried out using the original 16-item CONsolidated Standards Of Reporting Trials (CONSORT) for Abstracts checklist. For each abstract, an overall CONSORT score (OCS) was calculated (score range, 0 to 16). Univariable and multivariable linear regression analyses were performed to identify significant predictors of reporting quality. Chi-square (or Fisher's exact) tests were used to analyze the adequate reporting rate of each quality item by specialty area. A total of 129 RCT abstracts were included and assessed. The mean OCS was 4.5 (standard deviation, 1.3). Only three quality items (interventions, objective, conclusions) were reported adequately in most abstracts (>80 %). No abstract adequately reported results for the primary outcome, source of funding, and status of the trial. In addition, sufficient reporting of participants, outcome in the methods section, randomization, and trial registration was rare (<5 %). According to multivariable linear regression analysis, the specialty area of RCT abstracts was significantly associated with their reporting quality (P = 0.008). The reporting quality of RCT abstracts published in leading laser medicine journals is suboptimal. Joint efforts by authors, editors, and other stakeholders in the field to improve trial abstract reporting are needed.

  1. Exploring effective core drug patterns in primary insomnia treatment with Chinese herbal medicine: study protocol for a randomized controlled trial.

    PubMed

    Yan, Shiyan; Zhang, Runshun; Zhou, Xuezhong; Li, Peng; He, Liyun; Liu, Baoyan

    2013-02-28

    Chinese herbal medicine is one of the most popular Chinese medicine (CM) therapies for primary insomnia. One of the important characteristics of CM is that different Chinese clinicians give different prescriptions even for the same patient. However, there must be some fixed drug patterns in every clinician's prescriptions. This study aims to screen the effective core drug patterns in primary insomnia treatment of three prestigious Chinese clinicians. A triple-blind, randomized, placebo-controlled, parallel-group clinical trial will be performed. Three clinicians will diagnose and treat every eligible patient individually and independently, producing three prescriptions from three clinicians for every patient. Patients will equally be randomized to one of four groups - medical group A, medical group B, medical group C, or placebo group - and observed for efficacy of treatment. The sample will include primary insomnia patients meeting DSM IV-TR criteria, Spiegel scale score >18, and age 18 to 65 years. A sequential design is employed. Interim analysis will be conducted when between 80 and 160 patients complete the study. The interim study could be stopped and treated as final if a statistically significant difference between treatment and placebo groups can be obtained and core effective drug patterns can be determined. Otherwise, the study continues until the maximum sample size reaches 300. Treatment of the CM group is one of three Chinese clinicians' prescriptions, who provide independently prescriptions based on their own CM theory and the patient's disease condition. Assessment will be by sleep diary and Pittsburgh sleep quality index, and CM symptoms and signs will be measured. Primary outcome is total sleep time. Assessment will be carried out at the washout period, weeks 1, 2, 3, and 4 and 4th week after the end of treatment. Effectiveness analysis will be per intent to treat. A multi-dimension association rule and scale-free networks method will be used to

  2. Systematic review of the methodological quality of controlled trials evaluating Chinese herbal medicine in patients with rheumatoid arthritis

    PubMed Central

    Pan, Xin; Lopez-Olivo, Maria A; Song, Juhee; Pratt, Gregory; Suarez-Almazor, Maria E

    2017-01-01

    Objectives We appraised the methodological and reporting quality of randomised controlled clinical trials (RCTs) evaluating the efficacy and safety of Chinese herbal medicine (CHM) in patients with rheumatoid arthritis (RA). Design For this systematic review, electronic databases were searched from inception until June 2015. The search was limited to humans and non-case report studies, but was not limited by language, year of publication or type of publication. Two independent reviewers selected RCTs, evaluating CHM in RA (herbals and decoctions). Descriptive statistics were used to report on risk of bias and their adherence to reporting standards. Multivariable logistic regression analysis was performed to determine study characteristics associated with high or unclear risk of bias. Results Out of 2342 unique citations, we selected 119 RCTs including 18 919 patients: 10 108 patients received CHM alone and 6550 received one of 11 treatment combinations. A high risk of bias was observed across all domains: 21% had a high risk for selection bias (11% from sequence generation and 30% from allocation concealment), 85% for performance bias, 89% for detection bias, 4% for attrition bias and 40% for reporting bias. In multivariable analysis, fewer authors were associated with selection bias (allocation concealment), performance bias and attrition bias, and earlier year of publication and funding source not reported or disclosed were associated with selection bias (sequence generation). Studies published in non-English language were associated with reporting bias. Poor adherence to recommended reporting standards (<60% of the studies not providing sufficient information) was observed in 11 of the 23 sections evaluated. Limitations Study quality and data extraction were performed by one reviewer and cross-checked by a second reviewer. Translation to English was performed by one reviewer in 85% of the included studies. Conclusions Studies evaluating CHM often fail to

  3. A Randomized Controlled Trial of the Impact of a Teaching Procedure Service on the Training of Internal Medicine Residents

    PubMed Central

    Mourad, Michelle; Ranji, Sumant; Sliwka, Diane

    2012-01-01

    Introduction Academic medical centers must provide safe inpatient procedures while balancing resident autonomy and education. We performed a randomized, controlled trial to evaluate the effect of a 2-week hospitalist procedure service (HPS) rotation on interns' self-perceived procedure ability, knowledge, and autonomy versus the standard curriculum. Methods We randomly selected 16 of 57 internal medicine interns (28%) to participate in the intervention group rotation, with 29 interns in the control group. All interns were surveyed before the start of residency and at the end of the postgraduate year-1 (PGY-1) and PGY-2 years to evaluate self-reported knowledge and ability to (1) safely perform procedures, (2) supervise procedures, and (3) use bedside ultrasound. Results Ninety-four percent of HPS interns (15/16) and 71% of control interns (29/41) completed all surveys. Baseline knowledge and experience did not differ significantly between the groups. The intervention group performed significantly more paracentesis (9 versus 4; P < .001), thoracentesis (6 versus 2; P < .001), and lumbar puncture (4 versus 3; P < .001) procedures than did the control group. After their first year, residents who completed the HPS rotation rated their ability to safely perform and supervise all of the assessed procedures as higher (P < .05 for all procedures) and were more likely to rate self-perceived knowledge as very good or excellent in all surveyed aspects of procedure performance (P < .05). Discussion A 2-week hospitalist-supervised procedure service rotation substantially improved residents' experience, confidence, and knowledge in performing bedside procedures early in their training, with this effect sustained through the PGY-2 year. Standardized procedure service rotations are a viable solution for programs seeking to improve their procedure-based education. PMID:23730437

  4. 65. DETAIL OF ASSISTANT LAUNCH CONTROLLER AND LAUNCH CONTROLLER PANELS ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    65. DETAIL OF ASSISTANT LAUNCH CONTROLLER AND LAUNCH CONTROLLER PANELS LOCATED NEAR CENTER OF SLC-3E CONTROL ROOM. NOTE 30-CHANNEL COMMUNICATIONS PANELS. PAYLOAD ENVIRONMENTAL CONTROL AND MONITORING PANELS (LEFT) AND LAUNCH OPERATORS PANEL (RIGHT) IN BACKGROUND. - Vandenberg Air Force Base, Space Launch Complex 3, Launch Operations Building, Napa & Alden Roads, Lompoc, Santa Barbara County, CA

  5. Randomized placebo-controlled double-blind clinical trial of cannabis-based medicinal product (Sativex) in painful diabetic neuropathy: depression is a major confounding factor.

    PubMed

    Selvarajah, Dinesh; Gandhi, Rajiv; Emery, Celia J; Tesfaye, Solomon

    2010-01-01

    To assess the efficacy of Sativex, a cannabis-based medicinal extract, as adjuvant treatment in painful diabetic peripheral neuropathy (DPN). In this randomized controlled trial, 30 subjects with painful DPN received daily Sativex or placebo. The primary outcome measure was change in mean daily pain scores, and secondary outcome measures included quality-of-life assessments. There was significant improvement in pain scores in both groups, but mean change between groups was not significant. There were no significant differences in secondary outcome measures. Patients with depression had significantly greater baseline pain scores that improved regardless of intervention. This first-ever trial assessing the efficacy of cannabis has shown it to be no more efficacious than placebo in painful DPN. Depression was a major confounder and may have important implications for future trials on painful DPN.

  6. An overview of the current status of clinical trials on endometriosis: issues and concerns.

    PubMed

    Guo, Sun-Wei

    2014-01-01

    To examine and compare differences, if any, between industry- and nonindustry-sponsored clinical trials on endometriosis and to evaluate the effect of prior published positive preclinical results, or lack thereof, on trial status. Cross-sectional study of clinical trials on endometriosis that evaluate drugs/biologicals registered at ClinicalTrials.gov as of July 3, 2013. University-affiliated hospital. None. None. Trial status, size, phase, and duration; use of comparator groups; drug classes, number of arms, targeting conditions; and presence or absence of prior positive preclinical results before the launch of the trial. Eighty trials were identified. The trials sponsored by industry and non-industry have distinct features, differing in trial status, phase, comparator, drug classes, number of arms, trial size, and duration. The phase II/III trials are predominantly industry supported, but these trials frequently use placebo as the comparator. Trials launched without prior published preclinical results do not seem to fare well, although the presence of such studies is no guarantee for success. Questions as to whether the drug on trial is truly superior to the best available drug or of its cost-benefit profile are overlooked in most cases. There seems to be a deluge of "me-too" drugs with equivocal superiority over existing drugs and cost-benefit profiles. Because clinical trials are time-consuming, no blockbuster drug for endometriosis seems to be on the horizon yet. Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  7. Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England.

    PubMed

    Boyd, Matthew; Waring, Justin; Barber, Nick; Mehta, Rajnikant; Chuter, Antony; Avery, Anthony J; Salema, Nde-Eshimuni; Davies, James; Latif, Asam; Tanajewski, Lukasz; Elliott, Rachel A

    2013-12-01

    Medication non-adherence is considered an important cause of morbidity and mortality in primary care. This study aims to determine the effectiveness, cost effectiveness and acceptability of a complex intervention delivered by community pharmacists, the New Medicine Service (NMS), compared with current practice in reducing non-adherence to, and problems with, newly prescribed medicines for chronic conditions. Research subject group: patients aged 14 years and above presenting in a community pharmacy for a newly prescribed medicine for asthma/chronic obstructive pulmonary disease (COPD); hypertension; type 2 diabetes or anticoagulant/antiplatelet agents in two geographical regions in England. parallel group patient-level pragmatic randomized controlled trial. patients randomized to either: (i) current practice; or (ii) NMS intervention comprising pharmacist-delivered support for a newly prescribed medicine. proportion of adherent patients at six, ten and 26 weeks from the date of presenting their prescriptions at the pharmacy; cost effectiveness of the intervention versus current practice at 10 weeks and 26 weeks; in-depth qualitative understanding of the operationalization of NMS in pharmacies. impact of NMS on: patients' understanding of their medicines, pharmacovigilance, interprofessional and patient-professional relationships and experiences of service users and stakeholders.Economic analysis: Trial-based economic analysis (cost per extra adherent patient) and long-term modeling of costs and health effects (cost per quality-adjusted-life-year) will be conducted from the perspective of National Health Service (NHS) England, comparing NMS with current practice.Qualitative analysis: a qualitative study of NMS implementation in different community settings, how organizational influences affect NMS delivery, patterns of NMS consultations and experiences of professionals and patients participating in NMS, and patients receiving current practice. 250 patients in each

  8. Assessment of the Reporting Quality of Randomized Controlled Trials on the Treatment of Diabetes Mellitus with Traditional Chinese Medicine: A Systematic Review

    PubMed Central

    Wang, Ping; Xu, Qin; Sun, Qi; Fan, Fang-fang; Guo, Xue-rui; Guo, Fei

    2013-01-01

    Background After the publication of the CONSORT 2010 statement, few studies have been conducted to assess the reporting quality of randomized clinical trials (RCTs) on treatment of diabetes mellitus with Traditional Chinese Medicine (TCM) published in Chinese journals. Objective To investigate the current situation of the reporting quality of RCTs in leading medical journals in China with the CONSORT 2010 statement as criteria. Methods The China National Knowledge Infrastructure (CNKI) electronic database was searched for RCTs on the treatment of diabetes mellitus with TCM published in the Journal of Traditional Chinese Medicine, Chinese Journal of Integrated Traditional & Western Medicine, and the China Journal of Chinese Materia Medica from January to December 2011. We excluded trials reported as “animal studies”, “in vitro studies”, “case studies”, or “systematic reviews”. The CONSORT checklist was applied by two independent raters to evaluate the reporting quality of all eligible trials after discussing and comprehending the items thoroughly. Each item in the checklist was graded as either “yes” or “no” depending on whether it had been reported by the authors. Results We identified 27 RCTs. According to the 37 items in the CONSORT checklist, the average reporting percentage was 45.0%, in which the average reporting percentage for the “title and abstract”, the “introduction”, the “methods”, the “results”, the “discussion” and the “other information” was 33.3%, 88.9%, 36.4%, 54.4%, 71.6% and 14.8%, respectively. In the Journal of Traditional Chinese Medicine, Chinese Journal of Integrated Traditional & Western Medicine, and the China Journal of Chinese Materia Medica the average reporting percentage was 42.2%, 56.8%, and 46.0%, respectively. Conclusions The reporting quality of RCTs in these three journals was insufficient to allow readers to assess the validity of the trials. We recommend that editors require

  9. Rehabilitation for the management of knee osteoarthritis using comprehensive traditional Chinese medicine in community health centers: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background It is becoming increasingly necessary for community health centers to make rehabilitation services available to patients with osteoarthritis of the knee. However, for a number of reasons, including a lack of expertise, the small size of community health centers and the availability of only simple medical equipment, conventional rehabilitation therapy has not been widely used in China. Consequently, most patients with knee osteoarthritis seek treatment in high-grade hospitals. However, many patients cannot manage the techniques that they were taught in the hospital. Methods such as acupuncture, tuina, Chinese medical herb fumigation-washing and t’ai chi are easy to do and have been reported to have curative effects in those with knee osteoarthritis. To date, there have been no randomized controlled trials validating comprehensive traditional Chinese medicine for the rehabilitation of knee osteoarthritis in a community health center. Furthermore, there is no standard rehabilitation protocol using traditional Chinese medicine for knee osteoarthritis. The aim of the current study is to develop a comprehensive rehabilitation protocol using traditional Chinese medicine for the management of knee osteoarthritis in a community health center. Method/design This will be a randomized controlled clinical trial with blinded assessment. There will be a 4-week intervention utilizing rehabilitation protocols from traditional Chinese medicine and conventional therapy. Follow-up will be conducted for a period of 12 weeks. A total of 722 participants with knee osteoarthritis will be recruited. Participants will be randomly divided into two groups: experimental and control. Primary outcomes will include range of motion, girth measurement, the visual analogue scale, and results from the manual muscle, six-minute walking and stair-climbing tests. Secondary outcomes will include average daily consumption of pain medication, ability to perform daily tasks and health

  10. [Sport medicine].

    PubMed

    Epstein, Yoram

    2012-02-01

    It is only since the late 20th century that Sport and Exercise Medicine has emerged as a distinct entity in health care. In Israel, sports medicine is regulated by a State Law and a sport physician is certified after graduating a structured program. In the past, sports medicine was related to the diagnosis and treatment of injuries encountered by top athletes. In recent years, the scope of sport medicine has broadened to reflect the awareness of modern society of the dangers of physical inactivity. In this perspective the American College of Sport Medicine (ACSM) recently launched a program--"Exercise is Medicine", to promote physical activity in order to improve health and well-being and prevention of diseases through physical activity prescriptions. This program is from doctors and healthcare providers, adjusted to the patient or trainee. The sport physician does not replace a medical specialist, but having a thorough understanding about the etiology of a sport-related injury enables him to better focus on treatment and prevention. Therefore, Team Physicians in Elite Sport often play a role regarding not only the medical care of athletes, but also in the physiological monitoring of the athlete and correcting aberrations, to achieve peak physical performance. The broad spectrum of issues in sport and exercise medicine cannot be completely covered in one issue of the Journal. Therefore, the few reports that are presented to enhance interest and understanding in the broad spectrum of issues in sports and exercise medicine are only the tip of the iceberg.

  11. Antares Rocket Test Launch

    NASA Image and Video Library

    2013-04-21

    NASA Deputy Administrator Lori Garver and other guests react after having watched the successful launch of the Orbital Sciences Corporation Antares rocket from the Mid-Atlantic Regional Spaceport (MARS) at the NASA Wallops Flight Facility in Virginia, Sunday, April 21, 2013. The test launch marked the first flight of Antares and the first rocket launch from Pad-0A. The Antares rocket delivered the equivalent mass of a spacecraft, a so-called mass simulated payload, into Earth's orbit. Photo Credit: (NASA/Bill Ingalls)

  12. Antares Rocket Test Launch

    NASA Image and Video Library

    2013-04-21

    NASA Administrator Charles Bolden and NASA Deputy Administrator Lori Garver and other guests react after having watched the successful launch of the Orbital Sciences Corporation Antares rocket from the Mid-Atlantic Regional Spaceport (MARS) at the NASA Wallops Flight Facility in Virginia, Sunday, April 21, 2013. The test launch marked the first flight of Antares and the first rocket launch from Pad-0A. The Antares rocket delivered the equivalent mass of a spacecraft, a so-called mass simulated payload, into Earth's orbit. Photo Credit: (NASA/Bill Ingalls)

  13. STS-135 Launch Day

    NASA Image and Video Library

    2011-07-07

    NASA Chief, Astronaut Office, Johnson Space Center Peggy Whitson deals cards during a traditional game that is played at the NASA Kennedy Space Center Operations and Checkout Building with the shuttle crew prior to them leaving for the launch pad, on Friday, July 8, 2011 in Cape Canaveral, Fla. The point of the game is that the commander must use up all his or her bad luck before launch, so the crew can only leave for the pad after the commander loses. The launch of Atlantis, STS-135, is the final flight of the shuttle program, a 12-day mission to the International Space Station. Photo Credit: (NASA/Jerry Ross)

  14. STS-135 Atlantis Launch

    NASA Image and Video Library

    2011-07-08

    Space shuttle Atlantis is seen through the window of a Shuttle Training Aircraft (STA) as it launches from launch pad 39A at Kennedy Space Center on the STS-135 mission, Friday, July 8, 2011 in Cape Canaveral, Fla. Atlantis launched on the final flight of the shuttle program on a 12-day mission to the International Space Station. The STS-135 crew will deliver the Raffaello multipurpose logistics module containing supplies and spare parts for the space station. Photo Credit: (NASA/Dick Clark)

  15. Launch of Juno!

    NASA Image and Video Library

    An Atlas V rocket lofted the Juno spacecraft toward Jupiter from Space Launch Complex-41. The 4-ton Juno spacecraft will take five years to reach Jupiter on a mission to study its structure and dec...

  16. Genomic Data Commons launches

    Cancer.gov

    The Genomic Data Commons (GDC), a unified data system that promotes sharing of genomic and clinical data between researchers, launched today with a visit from Vice President Joe Biden to the operations center at the University of Chicago.

  17. Hi-C Launch

    NASA Image and Video Library

    The High resolution Coronal Imager (Hi-C) was launched on a NASA Black Brant IX two-stage rocket from White Sands Missile Range in New Mexico July 11, 2012. The experiment reached a maximum velocit...

  18. Launch - STS-6 - KSC

    NASA Image and Video Library

    1983-04-12

    S83-30222 (4 April 1983) --- The second reusable spacecraft in history successfully launches from Launch Pad 39A at 1:30:00:88 p.m. (EST) on April 4, 1983, and heads for its history making five-day mission in Earth orbit. The space shuttle Challenger, its two solid rocket boosters (SRB), and a new lightweight?external fuel tank were captured on film by an automatically-tripped camera in a protected station nearer to the launch pad than human beings are able to be at launch time. Onboard the spacecraft are astronauts Paul J. Wietz, Karol J. Bobko, Dr. Story Musgrave and Donald H. Peterson. Photo credit: NASA

  19. First Accessible Boat Launch

    EPA Pesticide Factsheets

    This is a story about how the Northwest Indiana urban waters partnership location supported the process to create and open the first handicap accessible canoe and kayak launch in the state of Indiana.

  20. IRVE 3 Launch

    NASA Image and Video Library

    The Inflatable Reentry Vehicle Experiment, or IRVE-3, launched on July 23, 2012, from NASA's Wallops Flight Facility. The purpose of the IRVE-3 test was to show that a space capsule can use an infl...

  1. GPM Launch Coverage

    NASA Image and Video Library

    A Japanese H-IIA rocket with the NASA-Japan Aerospace Exploration Agency (JAXA) Global Precipitation Measurement (GPM) Core Observatory aboard, launched from the Tanegashima Space Center in Japan o...

  2. NASA Now: Glory Launch

    NASA Image and Video Library

    In this episode of NASA Now, Dr. Hal Maring joins us to explain why the upcoming launch of the Glory satellite is so important to further our understanding of climate change. He also will speak on ...

  3. Comparison of conventional medicine, TCM treatment, and combination of both conventional medicine and TCM treatment for patients with chronic obstructive pulmonary disease: study protocol of a randomized comparative effectiveness research trial.

    PubMed

    Li, Jian-Sheng; Xie, Yang; Li, Su-Yun; Yu, Xue-Qing

    2014-05-01

    Chronic obstructive pulmonary disease (COPD) affects millions worldwide. Although many therapies exist and are being developed to relieve symptoms and reduce mortality, few data are available to understand which of the therapeutic alternatives is the most cost-effective for COPD patients in everyday clinical practice, especially for traditional Chinese medicine (TCM). Comparative effectiveness research can help patients, clinicians, and decision-makers make best informed treatment decisions where such evidence was previously lacking. This study aims to compare the effectiveness and economic evaluation of three treatments: (1) conventional Western medicine; (2) TCM treatments, which have been evaluated and have certain effect; and (3) a combination of both conventional Western medicine and TCM treatments, and then determine which treatment is the most suitable for COPD patients. A multicenter, pragmatic, randomized, controlled trial is adopted. A total of 360 patients will be recruited and randomly assigned to one of the three treatments group, with 120 in each group. Patients in the conventional Western medicine group will be given Salbutamol, Formoterol, Salmeterol/fluticasone, respectively, according to the guidelines. For the TCM group, patients will be given Bufei granule, Bu-Fei Jian-Pi granule, Bu-Fei Yi-Shen granule, and Yi-Qi Zi-Shen granule based on their corresponding TCM syndrome patterns, respectively. For the combination of conventional medicine and TCM treatments group, patients will be given a combination of conventional Western medicine and TCM granules. Treatments in each group are recognized as a whole comprehensive intervention. After the 26-week treatment, another 26 weeks will be followed up. The outcome measures including the frequency and duration of acute exacerbations, lung function, dyspnea, exercise capacity, quality of life, and economic evaluation will be assessed. It is hypothesized that each of the three treatments will have

  4. Vertical Launch Alignment Transfer Apparatus.

    DTIC Science & Technology

    A launch mechanism for vertically launching missiles carried in launch tubes disposed in a pod . The launch mechanism includes apparatus for... pod and v-groove elements are secured in the launch tubes and oriented to the northfinder. Rods are secured on opposite sides of each missile and are

  5. 33. Launch Control Center, close view of launch key inserted ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    33. Launch Control Center, close view of launch key inserted in the launch panel. Lyon - Whiteman Air Force Base, Oscar O-1 Minuteman Missile Alert Facility, Southeast corner of Twelfth & Vendenberg Avenues, Knob Noster, Johnson County, MO

  6. STS-51 Launch

    NASA Technical Reports Server (NTRS)

    1993-01-01

    space, the laboratories remain inside the payload bay throughout the mission. They are then removed after the Space Shuttle returns to Earth and can be reused on future flights. Some of these orbital laboratories, like the Spacelab, provide facilities for several specialists to conduct experiments in such fields as medicine, astronomy, and materials manufacturing. Some types of satellites deployed by Space Shuttles include those involved in environmental and resources protection, astronomy, weather forecasting, navigation, oceanographic studies, and other scientific fields. The Space Shuttles can also launch spacecraft into orbits higher than the Shuttle's altitude limit through the use of Inertial Upper Stage (IUS) propulsion units. After release from the Space Shuttle payload bay, the IUS is ignited to carry the spacecraft into deep space. The Space Shuttles are also being used to carry elements of the International Space Station into space where they are assembled in orbit. The Space Shuttles were built by Rockwell International's Space Transportation Systems Division, Downey, California. Rockwell's Rocketdyne Division (now part of Boeing) builds the three main engines, and Thiokol, Brigham City, Utah, makes the solid rocket booster motors. Martin Marietta Corporation (now Lockheed Martin), New Orleans, Louisiana, makes the external tanks. Each orbiter (Space Shuttle) is 121 feet long, has a wingspan of 78 feet, and a height of 57 feet. The Space Shuttle is approximately the size of a DC-9 commercial airliner and can carry a payload of 65,000 pounds into orbit. The payload bay is 60 feet long and 15 feet in diameter. Each main engine is capable of producing a sea level thrust of 375,000 pounds and a vacuum (orbital) thrust of 470,000 pounds. The engines burn a mixture of liquid oxygen and liquid hydrogen. In orbit, the Space Shuttles circle the earth at a speed of 17,500 miles per hour with each orbit taking about 90 minutes. A Space Shuttle crew sees a sunrise or

  7. STS-51 Launch

    NASA Technical Reports Server (NTRS)

    1993-01-01

    space, the laboratories remain inside the payload bay throughout the mission. They are then removed after the Space Shuttle returns to Earth and can be reused on future flights. Some of these orbital laboratories, like the Spacelab, provide facilities for several specialists to conduct experiments in such fields as medicine, astronomy, and materials manufacturing. Some types of satellites deployed by Space Shuttles include those involved in environmental and resources protection, astronomy, weather forecasting, navigation, oceanographic studies, and other scientific fields. The Space Shuttles can also launch spacecraft into orbits higher than the Shuttle's altitude limit through the use of Inertial Upper Stage (IUS) propulsion units. After release from the Space Shuttle payload bay, the IUS is ignited to carry the spacecraft into deep space. The Space Shuttles are also being used to carry elements of the International Space Station into space where they are assembled in orbit. The Space Shuttles were built by Rockwell International's Space Transportation Systems Division, Downey, California. Rockwell's Rocketdyne Division (now part of Boeing) builds the three main engines, and Thiokol, Brigham City, Utah, makes the solid rocket booster motors. Martin Marietta Corporation (now Lockheed Martin), New Orleans, Louisiana, makes the external tanks. Each orbiter (Space Shuttle) is 121 feet long, has a wingspan of 78 feet, and a height of 57 feet. The Space Shuttle is approximately the size of a DC-9 commercial airliner and can carry a payload of 65,000 pounds into orbit. The payload bay is 60 feet long and 15 feet in diameter. Each main engine is capable of producing a sea level thrust of 375,000 pounds and a vacuum (orbital) thrust of 470,000 pounds. The engines burn a mixture of liquid oxygen and liquid hydrogen. In orbit, the Space Shuttles circle the earth at a speed of 17,500 miles per hour with each orbit taking about 90 minutes. A Space Shuttle crew sees a sunrise or

  8. Experiences with Launch Vehicles

    NASA Technical Reports Server (NTRS)

    Dumbacher, Daniel L.

    2006-01-01

    The presentation "NASA Experience with Launch Vehicles" is a compilation of Mr. Dumbacher's career experiences with the Space Shuttle Program, the Delta - Clipper Experimental flight test project, the X-33 demonstrator project, and recent experiences with the Orbital Spaceplane Program agd the current NASA effort on Exploration Launch Systems. Mr. Dumbacher will discuss his personal experiences and provide lessons learned from each program. The accounts provided by Mr. Dumbacher are his own and do not necessarily represent the official NASA position.

  9. STS-130 Launch Attempt

    NASA Image and Video Library

    2010-02-07

    NASA Associate Administrator for Space Operations Bill Gerstenmaier, center, reacts to an updated weather report during the countdown of the launch of the space shuttle Endeavour and the start of the STS-130 mission at NASA Kennedy Space Center in Cape Canaveral, Fla. on Sunday Feb. 7, 2010. Space shuttle Endeavour's launch attempt was scrubbed due to a low cloud ceiling over Kennedy Space Center. Photo Credit: (NASA/Bill Ingalls)

  10. STS-132 Launch Tweetup

    NASA Image and Video Library

    2010-05-12

    Jon Cowart @Rocky_Sci, orbiter engineering manager, Space Shuttle Program, interacts with Tweetup participant, Jen Vargas, @jenvargus, as he speaks to participants at the two-day STS-132 Launch Tweetup at Kennedy Space Center, Thursday, May 13, 2010, in Cape Canaveral, Fla. NASA Twitter followers in attendance will have the opportunity to take a tour of NASA's Kennedy Space Center, view the space shuttle launch and speak with shuttle technicians, engineers, astronauts and managers. Photo Credit: (NASA/Paul E. Alers)

  11. Expedition 23 Launch Day

    NASA Image and Video Library

    2010-04-01

    Expedition 23 Flight Engineer Mikhail Kornienko of the Russia has his Russian Sokol suit prepared for launch by a technician at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Friday, April 2, 2010. Kornienko and fellow Expedition 23 crewmembers Soyuz Commander Alexander Skvortsov and NASA Flight Engineer Tracy Caldwell Dyson of the U.S. launched in their Soyuz TMA-18 rocket from the Baikonur Cosmodrome in Kazakhstan on Friday, April 2, 2010. Photo Credit: (NASA/Carla Cioffi)

  12. Expedition 23 Launch Day

    NASA Image and Video Library

    2010-04-01

    Expedition 23 Soyuz Commander Alexander Skvortsov has his Russian Sokol suit prepared for launch by a technician at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Friday, April 2, 2010. Skvortsov and fellow Expedition 23 crewmembers Flight Engineer Mikhail Kornienko of the Russia and NASA Flight Engineer Tracy Caldwell Dyson of the U.S. launched in their Soyuz TMA-18 rocket from the Baikonur Cosmodrome in Kazakhstan on Friday, April 2, 2010. Photo Credit: (NASA/Carla Cioffi)

  13. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-20

    Expedition 22 Flight Engineer Soichi Noguchi of Japan has his Russian Sokol suit prepared for launch by a technician at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Sunday, Dec. 20, 2009. Soichi and fellow Expedition 22 crew members NASA Flight Engineer Timothy J. Creamer of the U.S., Soyuz Commander Oleg Kotov of Russia launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  14. Expedition 23 Launch Day

    NASA Image and Video Library

    2010-04-01

    Expedition 23 NASA Flight Engineer Tracy Caldwell Dyson, left, talks with Soyuz Commander Alexander Skvortsov of Russia, while Flight Engineer Mikhail Kornienko of Russia has his Russian Sokol suit prepared for launch at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Friday, April 2, 2010. The Expedition 23 crew members launched in their Soyuz TMA-18 rocket from the Baikonur Cosmodrome in Kazakhstan on Friday, April 2, 2010. (Photo Credit: NASA/Bill Ingalls)

  15. Expedition 23 Launch Day

    NASA Image and Video Library

    2010-04-01

    Expedition 23 NASA Flight Engineer Tracy Caldwell Dyson of the U.S. has her Russian Sokol suit prepared for launch by a technician at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Friday, April 2, 2010. Caldwell Dyson and fellow Expedition 23 crew members Soyuz Commander Alexander Skvortsov and Flight Engineer Mikhail Kornienko of Russia launched in their Soyuz TMA-18 rocket from the Baikonur Cosmodrome in Kazakhstan on Friday, April 2, 2010. Photo Credit: (NASA/Carla Cioffi)

  16. Expedition 25 Launch

    NASA Image and Video Library

    2010-10-07

    Expedition 25 NASA Flight Engineer Scott Kelly of the U.S. has his Russian Sokol suit prepared for launch by a technician at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Friday, Oct. 8, 2010. Kelly and fellow Expedition 25 crew members Soyuz Commander Alexander Kaleri and Flight Engineer Oleg Skripochka launched in their Soyuz TMA-01M at 5:10 a.m. Friday morning. (Photo Credit: NASA/Carla Cioffi)

  17. Expedition 25 Launch

    NASA Image and Video Library

    2010-10-07

    The Soyuz TMA-01M rocket launches from the Baikonur Cosmodrome in Kazakhstan on Friday, October 8, 2010 carrying Expedition 25 Soyuz Commander Alexander Kaleri of Russia, NASA Flight Engineer Scott J. Kelly and Russian Flight Engineer Oleg Skripochka to the International Space Station. Their Soyuz TMA-01M rocket launched at 5:10 a.m Kazakhstan time. (Photo Credit: NASA/Carla Cioffi)

  18. Expedition 25 Launch

    NASA Image and Video Library

    2010-10-07

    Expedition 25 NASA Flight Engineer Scott Kelly of the U.S. has his Russian Sokol suit prepared for launch by a technician at the Baikonur Cosmodrome in Kazakhstan, Friday, Oct. 8, 2010. Kelly and fellow Expedition 25 crew members Soyuz Commander Alexander Kaleri and Flight Engineer Oleg Skripochka launched in their Soyuz TMA-01M at 5:10 a.m. Friday morning. (Photo Credit: NASA/Carla Cioffi)

  19. STS-64 launch view

    NASA Technical Reports Server (NTRS)

    1994-01-01

    Passing through some of the trailer clouds of an overcast sky which temporarily postponed its launch, the Space Shuttle Discovery heads for its 19th Earth orbital flight. Several kilometers away, astronaut John H. Casper, Jr., who took this picture, was piloting the Shuttle Training Aircraft (STA) from which the launch and landing area weather was being monitored. Onboard Discovery were astronauts Richard N. Richards, L. Blaine Hammond, Jr., Mark C. Lee, Carl J. Meade, Susan J. Helms, and Jerry M. Linenger.

  20. Orion EFT-1 Launch

    NASA Image and Video Library

    2014-12-05

    A Delta IV Heavy rocket lifts off from Space Launch Complex 37 at Cape Canaveral Air Force Station in Florida carrying NASA's Orion spacecraft on an unpiloted flight test to Earth orbit. Liftoff was at 7:05 a.m. EST. During the two-orbit, four-and-a-half hour mission, engineers will evaluate the systems critical to crew safety, the launch abort system, the heat shield and the parachute system.

  1. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-21

    Expedition 22 Soyuz Commander Oleg Kotov of Russia, left, NASA Flight Engineer Timothy J. Creamer of the U.S., back center, and Flight Engineer Soichi Noguchi of Japan are walked from their bus to the soyuz rocket at the launch pad at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Monday, Dec. 21, 2009. Kotov, Creamer and Noguchi launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  2. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-20

    Expedition 22 Soyuz Commander Oleg Kotov of Russia, center, has his Russian Sokol suit prepared for launch while NASA Flight Engineer Timothy J. Creamer of the U.S., left, and Flight Engineer Soichi Noguchi of Japan wait at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Sunday, Dec. 20, 2009. The Expedition 22 crew members launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  3. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-20

    Expedition 22 NASA Flight Engineer Timothy J. Creamer of the U.S. has his Russian Sokol suit prepared for launch by a technician at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Sunday, Dec. 20, 2009. Creamer and fellow Expedition 22 crew members, Soyuz Commander Oleg Kotov of Russia, Flight Engineer Soichi Noguchi of Japan launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  4. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-20

    Expedition 22 NASA Flight Engineer Timothy J. Creamer of the U.S., left, talks with Soyuz Commander Oleg Kotov of Russia, right, while Flight Engineer Soichi Noguchi of Japan has his Russian Sokol suit prepared for launch at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Sunday, Dec. 20, 2009. The Expedition 22 crew members launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  5. Magnetic Launch Assist

    NASA Technical Reports Server (NTRS)

    Perez, Jose

    2000-01-01

    The objectives of this program are to: (1) To develop a safe, reliable, inexpensive, and minimum operation launch assist system for sending payloads into orbit using ground powered, magnetic suspension and propulsion technologies; (2) Improve safety, reliability, operability for third generation Reusable Launch Vehicles (RLV); (3) Reduce vehicle weight and increase payload capacity; and (4) Support operational testing of Rocket Based Combine Cycle (RBCC) engines.

  6. STS-132 Launch Tweetup

    NASA Image and Video Library

    2010-05-12

    Kendal Van Dyke, a database professional that is followed on Twitter @twitter.com/sqldba, takes part in the two-day STS-132 Launch Tweetup at Kennedy Space Center, Thursday, May 13, 2010, in Cape Canaveral, Fla. NASA Twitter followers in attendance will have the opportunity to take a tour of NASA's Kennedy Space Center, view the space shuttle launch and speak with shuttle technicians, engineers, astronauts and managers. Photo Credit: (NASA/Paul E. Alers)

  7. Expedition 8 Launch Day

    NASA Image and Video Library

    2003-10-18

    Technicians conduct a leak check on the spacesuit of Expedition 8 Soyuz Commander Alexander Kaleri at the Baikonur Cosmodrome, Saturday, Oct. 18, 2003, prior to his departure for the launch pad with Expedition 8 Commander and NASA Science Officer Mike Foale and European Space Agency astronaut Pedro Duque of Spain. The trio were launched on a Soyuz TMA-3 vehicle to the International Space Station, arriving on Oct. 20. Photo Credit (NASA/Bill Ingalls)

  8. Expedition 8 Launch Day

    NASA Image and Video Library

    2003-10-18

    Technicians conduct a leak check on the spacesuit of European Space Agency astronaut Pedro Duque of Spain at the Baikonur Cosmodrome, Saturday, Oct. 18, 2003, prior to his departure for the launch pad with Expedition 8 Commander and NASA Science Officer Mike Foale and Soyuz Commander Alexander Kaleri. The trio were launched on a Soyuz TMA-3 vehicle to the International Space Station, arriving on Oct. 20. Photo Credit (NASA/Bill Ingalls)

  9. Expedition 8 Launch Day

    NASA Image and Video Library

    2003-10-18

    Expedition 8 Commander and NASA Science Officer Michael Foale completes suiting up at the Baikonur Cosmodrome in Kazakhstan, Saturday, Oct. 18, 2003, prior to departing for the launch pad with Expedition 8 Soyuz Commander Alexander Kaleri and European Space Agency astronaut Pedro Duque of Spain. The trio were launched on the Soyuz TMA-3 vehicle to the International Space Station, arriving on Oct. 20. Photo Credit (NASA/Bill Ingalls)

  10. Launch Vehicle Communications

    NASA Technical Reports Server (NTRS)

    Welch, Bryan; Greenfeld, Israel

    2005-01-01

    As the National Aeronautics and Space Administration's (NASA) planning for updated launch vehicle operations progresses, there is a need to consider improved methods. This study considers the use of phased array antennas mounted on launch vehicles and transmitting data to either NASA's Tracking and Data Relay Satellite System (TDRSS) satellites or to the commercial Iridium, Intelsat, or Inmarsat communications satellites. Different data rate requirements are analyzed to determine size and weight of resulting antennas.

  11. STS-135 Atlantis Launch

    NASA Image and Video Library

    2011-07-08

    Guests look on from the terrace of Operations Support Building II as space shuttle Atlantis launches from launch pad 39A on the STS-135 mission Friday, July 8, 2011, at Kennedy Space Center in Cape Canaveral, Fla. Atlantis and its crew will deliver to the International Space Station the Raffaello multipurpose logistics module containing supplies and spare parts for the space station. Photo Credit: (NASA/Carla Cioffi)

  12. STS-135 Atlantis Launch

    NASA Image and Video Library

    2011-07-08

    Space shuttle Atlantis, STS-135, launches skyward on a 12-day mission to the International Space Station (ISS), Friday, July 8, 2011, at NASA's Kennedy Space Center in Cape Canaveral, Fla. The launch of Atlantis is the final flight of the shuttle program and will carry the Raffaello multipurpose logistics module containing supplies and spare parts for the space station. Photo Credit: (NASA/Paul E. Alers)

  13. Orion EFT-1 Launch

    NASA Image and Video Library

    2014-12-05

    A Delta IV Heavy rocket roars to life at Space Launch Complex 37 at Cape Canaveral Air Force Station in Florida. The launch vehicle is carrying NASA's Orion spacecraft on an unpiloted flight test to Earth orbit. Liftoff was at 7:05 a.m. EST. The flight will send Orion 3,600 miles in altitude beyond the Earth's surface on a four-and-a-half hour mission.

  14. STS-132 Launch Tweetup

    NASA Image and Video Library

    2010-05-12

    Ron Woods, an equipment specialist, who has been a space suit designer from Mercury to now speaks to participants at the two-day STS-132 Launch Tweetup at Kennedy Space Center, Thursday, May 13, 2010, in Cape Canaveral, Fla. NASA Twitter followers in attendance will have the opportunity to take a tour of NASA's Kennedy Space Center, view the space shuttle launch and speak with shuttle technicians, engineers, astronauts and managers. Photo Credit: (NASA/Paul E. Alers)

  15. Semi-individualised Chinese medicine treatment as an adjuvant management for diabetic nephropathy: a pilot add-on, randomised, controlled, multicentre, open-label pragmatic clinical trial

    PubMed Central

    Chan, Kam Wa; Ip, Tai Pang; Kwong, Alfred Siu Kei; Lui, Sing Leung; Chan, Gary Chi Wang; Cowling, Benjamin John; Yiu, Wai Han; Wong, Dickson Wai Leong; Liu, Yang; Feng, Yibin; Tan, Kathryn Choon Beng; Chan, Loretta Yuk Yee; Leung, Joseph Chi Kam; Lai, Kar Neng; Tang, Sydney Chi Wai

    2016-01-01

    Introduction Diabetes mellitus and diabetic nephropathy (DN) are prevalent and costly to manage. DN is the leading cause of end-stage kidney disease. Conventional therapy blocking the renin–angiotensin system has only achieved limited effect in preserving renal function. Recent observational data show that the use of Chinese medicine (CM), a major form of traditional medicine used extensively in Asia, could reduce the risk of end-stage kidney disease. However, existing clinical practice guidelines are weakly evidence-based and the effect of CM remains unclear. This trial explores the effect of an existing integrative Chinese–Western medicine protocol for the management of DN. Objective To optimise parameters and assess the feasibility for a subsequent phase III randomised controlled trial through preliminary evaluation on the effect of an adjuvant semi-individualised CM treatment protocol on patients with type 2 diabetes with stages 2–3 chronic kidney disease and macroalbuminuria. Methods and analysis This is an assessor-blind, add-on, randomised, controlled, parallel, multicentre, open-label pilot pragmatic clinical trial. 148 patients diagnosed with DN will be recruited and randomised 1:1 to a 48-week additional semi-individualised CM treatment programme or standard medical care. Primary end points are the changes in estimated glomerular filtration rate and spot urine albumin-to-creatinine ratio between baseline and treatment end point. Secondary end points include fasting blood glucose, glycated haemoglobin, brain natriuretic peptide, fasting insulin, C peptide, fibroblast growth factor 23, urinary monocyte chemotactic protein-1, cystatin C, nephrin, transforming growth factor-β1 and vascular endothelial growth factor. Adverse events are monitored through self-completed questionnaire and clinical visits. Outcomes will be analysed by regression models. Enrolment started in July 2015. Ethics and registration This protocol is approved by the Institutional

  16. Economic endpoints in clinical trials.

    PubMed

    Cook, John; Drummond, Michael; Heyse, Joseph F

    2004-04-01

    Healthcare decision makers are increasingly requesting information on the cost and cost-effectiveness of new medicines at the time of product launch. In order to provide this information, data on healthcare resource utilization and, in some cases, costs, may be collected in clinical trials. In this paper, we discuss some of the issues statisticians need to address when it is appropriate to include these economic endpoints in the trial. Several design issues are discussed, including the alternative types of and methods for collecting economic endpoint data, sample size and generalizability. Alternative approaches in the analysis of resource utilization, cost and cost-effectiveness are also presented. Finally, several of the analytic approaches are applied to actual data from a clinical trial.

  17. Electromagnetic Launch to Space

    NASA Astrophysics Data System (ADS)

    McNab, I. R.

    Many advances in electromagnetic (EM) propulsion technology have occurred in recent years. Linear motor technology for low-velocity and high-mass applications is being developed for naval catapults. Such technology could serve as the basis for a first-stage booster launch--as suggested by the US National Aeronautics and Space Administration (NASA) in the Maglifter concept. Using railguns, laboratory experiments have demonstrated launch velocities of 2-3 km/s and muzzle energies > 8 MJ. The extension of this technology to the muzzle velocities ( 7500 m/s) and energies ( 10 GJ) needed for the direct launch of payloads into orbit is very challenging but may not be impossible. For launch to orbit, even long launchers (> 1000 m) would need to operate at accelerations > 1000 G to reach the required velocities, so it would only be possible to launch rugged payloads, such as fuel, water, and materiel. Interest is being shown in such concepts by US, European, Russian, and Chinese researchers. An intermediate step proposed in France could be to launch payloads to sounding rocket altitudes for ionospheric research.

  18. Chinese Herbal Medicine Qi Ju Di Huang Wan for the Treatment of Essential Hypertension: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Wang, Jie; Xiong, Xingjiang; Yang, Guoyan; Zhang, Yuqing; Liu, Yongmei; Zhang, Yun; Zhang, Zhenpeng; Li, Jun; Yang, Xiaochen

    2013-01-01

    Background. Chinese herbs are potentially effective for hypertension. Qi Ju Di Huang Wan (QJDHW) is a commonly used Chinese herbal medicine as a monotherapy or in combination with other antihypertensive agents for the treatment of essential hypertension (EH). However, there is no critically appraised evidence such as systematic reviews or meta-analyses on the effectiveness and safety of QJDHW for EH. Methods and Findings. CENTRAL, PubMed, CBM, CNKI, VIP, and online clinical trial registry websites were searched for published and unpublished randomized controlled trials (RCTs) of QJDHW for essential hypertension up to January 2013 with no language restrictions. A total of 10 randomized trials involving 1024 patients were included. Meta-analysis showed that QJDHW combined with antihypertensive drugs was more effective in lowering blood pressure and improving TCM syndrome for the treatment of essential hypertension than antihypertensive drugs used alone. No trials reported severe adverse events related to QJDHW. Conclusions. Our review suggests that QJDHW combined with antihypertensive drugs might be an effective treatment for lowering blood pressure and improving symptoms in patients with essential hypertension. However, the finding should be interpreted with caution because of the poor methodological quality of included trials. There is an urgent need for well-designed, long-term studies to assess the effectiveness of QJDHW in the treatment of essential hypertension. PMID:23878593

  19. Efficacy of Chinese Herbal Medicine for Diarrhea-Predominant Irritable Bowel Syndrome: A Meta-Analysis of Randomized, Double-Blind, Placebo-Controlled Trials

    PubMed Central

    Liu, Shan; Su, Xiao-Lan; Wang, Zi-Song; Li, Yi-Jie; Yang, Yang; Hou, Li-Wei; Wang, Qing-Guo; Wei, Ru-Han; Yang, Jian-Qin

    2016-01-01

    Objective. To explore the efficacy of Chinese herbal medicine in treating diarrhea-predominant irritable bowel syndrome (D-IBS). Methods. Four English and four Chinese databases were searched through November, 2015. Randomized, double-blind and placebo-controlled trials were selected. Data extraction and quality evaluation were performed by two authors independently. RevMan 5.2.0 software was applied to analyze the data of included trials. Results. A total of 14 trials involving 1551 patients were included. Meta-analysis demonstrated superior global symptom improvement (RR = 1.62; 95% CI 1.31, 2.00; P < 0.00001; number needed to treat = 3.6), abdominal pain improvement (RR = 1.95; 95% CI 1.61, 2.35; P < 0.00001), diarrhea improvement (RR = 1.87; 95% CI 1.60, 2.20; P < 0.00001), pain threshold assessment (MD = 54.53; 95% CI 38.76, 70.30; P < 0.00001), and lower IBS Symptom Severity Score (SMD = −1.01; 95% CI −1.72, −0.30; P = 0.005), when compared with placebo, while for defecation threshold assessment, quality of life, and adverse events, no differences were found between treatment groups and controlled groups. Conclusion. This meta-analysis shows that Chinese herbal medicine is an effective and safe treatment for D-IBS. However, due to the small sample size and high heterogeneity, further studies are required. PMID:27547226

  20. GPM Core Observatory Launch Animation

    NASA Image and Video Library

    This animation depicts the launch of the Global Precipitation Measurement (GPM) Core Observatory satellite from Tanegashima Space Center, Japan. The launch is currently scheduled for Feb. 27, 2014....

  1. Ares Launch Vehicles Overview

    NASA Technical Reports Server (NTRS)

    Vanhooser, Teresa

    2009-01-01

    Since 2005, the Ares Projects have been building the nation s next generation of crew and cargo launch vehicles. As part of the Constellation Program, the Ares vehicles will enable astronauts in the Orion crew exploration vehicle and Altair lunar lander to reach the Moon and beyond. These vehicles draw upon hardware and experienced developed over 50 years of exploration, while also incorporating technology and management practices from today. Ares is concentrating on building the Ares I crew launch vehicle to ensure America s continued ability to send crews to the International Space Station. Progress has been made on design, fabrication, and testing for the first stage, upper stage, upper stage engine, and integrated vehicle. This presentation will provide an overview of the Ares launch vehicles architecture, milestone progress, and top project risks.

  2. STS-133 launch

    NASA Image and Video Library

    2011-02-24

    STS133-S-067 (24 Feb. 2011) --- In Firing Room 4 of the Launch Control Center at NASA's Kennedy Space Center in Florida, NASA's Discovery Flow Director Stephanie Stilson, left, STS-133 Assistant Shuttle Launch Director and lead NASA Test Director Charlie Blackwell-Thompson and Shuttle Launch Director Mike Leinbach watch space shuttle Discovery head toward Earth orbit on the STS-133 mission to the International Space Station. Discovery and its six-member crew are on a mission to deliver the Permanent Multipurpose Module, packed with supplies and critical spare parts, as well as Robonaut 2, the dexterous humanoid astronaut helper, to the orbiting outpost. Discovery is making its 39th mission and is scheduled to be retired following STS-133. This is the 133rd Space Shuttle Program mission and the 35th shuttle voyage to the space station. Photo credit: NASA or National Aeronautics and Space Administration

  3. STS-135 Launch Day

    NASA Image and Video Library

    2011-07-07

    NASA Chief, Astronaut Office, Johnson Space Center Peggy Whitson, center, STS-135 Astronauts, Rex Walheim, left, and Commander Chris Ferguson are seen as the entire crew plays a traditional card game at the NASA Kennedy Space Center Operations and Checkout Building prior to them leaving for the launch pad, on Friday, July 8, 2011 in Cape Canaveral, Fla. The point of the game is that the commander must use up all his or her bad luck before launch, so the crew can only leave for the pad after the commander loses. The launch of Atlantis, STS-135, is the final flight of the shuttle program, a 12-day mission to the International Space Station. Photo Credit: (NASA/Jerry Ross)

  4. Antares Rocket Test Launch

    NASA Image and Video Library

    2013-04-21

    NASA Deputy Administrator Lori Garver talks with CEO and President of Orbital Sciences Corporation David Thompson, left, Executive Vice President and Chief Technical Officer, Orbital Sciences Corporation Antonio Elias, second from left, and Executive Director, Va. Commercial Space Flight Authority Dale Nash, background, in the Range Control Center at the NASA Wallops Flight Facility after the successful launch of the Orbital Sciences Antares rocket from the Mid-Atlantic Regional Spaceport (MARS) in Virginia, Sunday, April 21, 2013. The test launch marked the first flight of Antares and the first rocket launch from Pad-0A. The Antares rocket delivered the equivalent mass of a spacecraft, a so-called mass simulated payload, into Earth's orbit. Photo Credit: (NASA/Bill Ingalls)

  5. AXONOMETRIC, LAUNCH DOOR AND DOOR CYLINDER, LAUNCH PLATFORM ROLLER GUIDE, ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    AXONOMETRIC, LAUNCH DOOR AND DOOR CYLINDER, LAUNCH PLATFORM ROLLER GUIDE, CRIB SUSPENSION SHOCK STRUT, LAUNCH PLATFORM - Dyess Air Force Base, Atlas F Missle Site S-8, Launch Facility, Approximately 3 miles east of Winters, 500 feet southwest of Highway 1770, center of complex, Winters, Runnels County, TX

  6. Launch of Vanguard

    NASA Technical Reports Server (NTRS)

    1955-01-01

    Launch of a three-stage Vanguard (SLV-7) from Cape Canaveral, Florida, September 18, 1959. Designated Vanguard III, the 100-pound satellite was used to study the magnetic field and radiation belt. In September 1955, the Department of Defense recommended and authorized the new program, known as Project Vanguard, to launch Vanguard booster to carry an upper atmosphere research satellite in orbit. The Vanguard vehicles were used in conjunction with later booster vehicle such as the Thor and Atlas, and the technique of gimbaled (movable) engines for directional control was adapted to other rockets.

  7. Expedition 18 Launch Day

    NASA Image and Video Library

    2008-10-11

    Expedition 18 Flight Engineer Yuri V. Lonchakov, bottom, Expedition 18 Commander Michael Fincke and American spaceflight participant Richard Garriott, top, wave farewell from the steps of the Soyuz launch pad prior to their launch in the Soyuz TMA-13 spacecraft, Sunday, Oct. 12, 2008 from the Baikonur Cosmodrome in Kazakhstan. The three crew members are scheduled to dock with the International Space Station on Oct. 14. Fincke and Lonchakov will spend six months on the station, while Garriott will return to Earth Oct. 24 with two of the Expedition 17 crew members currently on the International Space Station. Photo Credit: (NASA/Bill Ingalls)

  8. LAUNCH - APOLLO 9 - CAPE

    NASA Image and Video Library

    1969-03-03

    S69-25862 (3 March 1969) --- Framed by palm trees in the foreground, the Apollo 9 (Spacecraft 104/Lunar Module 3/ Saturn 504) space vehicle is launched from Pad A, Launch Complex 39, Kennedy Space Center (KSC) at 11 a.m. (EST), March 3, 1969. Aboard the spacecraft are astronauts James A. McDivitt, commander; David R. Scott, command module pilot; and Russell L. Schweickart, lunar module pilot. The Apollo 9 mission will evaluate spacecraft lunar module systems performance during manned Earth-orbital flight. Apollo 9 is the second manned Saturn V mission.

  9. APOLLO VII - LAUNCH - KSC

    NASA Image and Video Library

    1968-10-11

    S68-48662 (11 Oct. 1968) --- The Apollo 7/Saturn IB space vehicle is launched from the Kennedy Space Center's Launch Complex 34 at 11:03 a.m. (EDT), Oct. 11, 1968. Apollo 7 (Spacecraft 101/Saturn 205) is the first of several manned flights aimed at qualifying the spacecraft for the half-million mile round trip to the moon. Aboard the Apollo spacecraft are astronauts Walter M. Schirra Jr., commander; Donn F. Eisele, command module pilot; and Walter Cunningham, lunar module pilot. (This view is framed by palm trees on either side).

  10. NPP Satellite Launch

    NASA Image and Video Library

    2011-10-28

    The Satellite Operations Facility of the National Oceanic and Atmospheric Administration (NOAA) is seen here minutes before the launch of the National Polar-orbiting Operational Environmental Satellite System Preparatory Project (NPP) on Friday, Oct. 28, 2011 in Suitland, Md. NPP is a joint venture between NASA and NOAA, and is the nation's newest Earth-observing satellite, which will provide data on climate change science, allow for accurate weather forecasts and advance warning for severe weather. NPP was launched from Vandenberg Air Force Base in California. Photo Credit: (NASA/Carla Cioffi)

  11. NPP Satellite Launch

    NASA Image and Video Library

    2011-10-28

    Dr. Kathy Sullivan, center, Deputy Administrator of the National Oceanic and Atmospheric Administration (NOAA) and former NASA astronaut is interviewed by a local television network at NOAA's Satellite Operations Facility in Suitland, Md. after the successful launch of the National Polar-orbiting Operational Environmental Satellite System Preparatory Project (NPP) on Friday, Oct. 28, 2011. NPP is a joint venture between NASA and NOAA, and is the nation's newest Earth-observing satellite, which will provide data on climate change science, allow for accurate weather forecasts and advance warning for severe weather. NPP was launched from Vandenberg Air Force Base in California. Photo Credit: (NASA/Carla Cioffi)

  12. NPP Satellite Launch

    NASA Image and Video Library

    2011-10-28

    NASA Deputy Administrator Lori Garver, left, watches the launch of the National Polar-orbiting Operational Environmental Satellite System Preparatory Project (NPP) at the National Oceanic and Atmospheric Administration (NOAA) Satellite Operations Center on Friday, Oct. 28, 2011 in Suitland, Md. U.S Congresswoman Donna Edwards, D-Md., is seen next to Garver. NPP is a joint venture between NASA and NOAA, and is the nation's newest Earth-observing satellite, which will provide data on climate change science, allow for accurate weather forecasts and advance warning for severe weather. NPP was launched from Vandenberg Air Force Base in California. Photo Credit: (NASA/Carla Cioffi)

  13. Expedition 8 Launch Day

    NASA Image and Video Library

    2003-10-18

    With a throng of reporters looking on, the prime and backup crews for the Expedition 8 mission to the International Space Station and the prime and backup European Space Agency Astronauts receive final well-wishes from Russian and U.S. space officials at the Baikonur Cosmodrome in Kazakhstan, Saturday, Oct. 18, 2003, before heading to the launch pad. Expedition 8 Commander and NASA Science Officer Michael Foale, Expedition 8 Soyuz Commander Alexander Kaleri and ESA's Pedro Duque of Spain were launched on a Soyuz TMA-3 vehicle, arriving at the ISS on Oct. 20. Photo Credit (NASA/Bill Ingalls)

  14. LDSD Ready for Launch

    NASA Image and Video Library

    2015-06-05

    NASA's Low-Density Supersonic Decelerator (LDSD) hangs from a launch tower at U.S. Navy's Pacific Missile Range Facility in Kauai, Hawaii. The saucer-shaped vehicle will test two devices for landing heavy payloads on Mars: an inflatable donut-shaped device and a supersonic parachute. The launch tower helps link the vehicle to a balloon; once the balloon floats up, the vehicle is released from the tower and the balloon carries it to high altitudes. The vehicle's rocket takes it to even higher altitudes, to the top of the stratosphere, where the supersonic test begins. http://photojournal.jpl.nasa.gov/catalog/PIA19342

  15. STS-64 launch view

    NASA Technical Reports Server (NTRS)

    1994-01-01

    With a crew of six NASA astronauts aboard, the Space Shuttle Discovery heads for its nineteenth Earth-orbital mission. Launch was delayed because of weather, but all systems were 'go,' and the spacecraft left the launch pad at 6:23 p.m. (EDT) on September 9, 1994. Onboard were astronauts Richard N. Richards, L. Blaine Hammond, Carl J. Meade, Mark C. Lee, Susan J. Helms, and Jerry M. Linenger (051-2); Making a bright reflection in nearby marsh waters, the Space Shuttle Discovery heads for its 19th mission in earth orbit (053).

  16. STS-64 launch view

    NASA Technical Reports Server (NTRS)

    1994-01-01

    With a crew of six NASA astronauts aboard, the Space Shuttle Discovery heads for its nineteenth Earth-orbital mission. Launch was delayed because of weather, but all systems were 'go,' and the spacecraft left the launch pad at 6:23 p.m. (EDT) on September 9, 1994. Onboard were astronauts Richard N. Richards, L. Blaine Hammond, Carl J. Meade, Mark C. Lee, Susan J. Helms, and Jerry M. Linenger (051-2); Making a bright reflection in nearby marsh waters, the Space Shuttle Discovery heads for its 19th mission in earth orbit (053).

  17. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-20

    Expedition 22 Flight Engineer Soichi Noguchi of Japan has his Russian Sokol suit prepared for launch by a technician while space agency photographers document the process at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Sunday, Dec. 20, 2009. Soichi and fellow Expedition 22 crew members NASA Flight Engineer Timothy J. Creamer of the U.S., Soyuz Commander Oleg Kotov of Russia launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  18. Launch - STS-6 - KSC

    NASA Image and Video Library

    1983-04-06

    S83-30134 (7 April 1983) --- Flare from the first launch of the space shuttle Challenger is reflected in the Atlantic Ocean?s Cape Canaveral beach waters shortly after 1:30 p.m. (EST) on April 7, 1983. Only the tips of the orbiter?s wings are visible in this south looking view, as the manned portion of the launch cluster is obscured by its new lightweight external fuel tank (ET) and two solid rocket boosters (SRB). Onboard the spacecraft are astronauts Paul J. Weitz, Karol J. Bobko, Dr. F. Story Musgrave and Donald H. Peterson. Photo credit: NASA

  19. STS-56 Launch

    NASA Technical Reports Server (NTRS)

    1993-01-01

    The second try works like a charm as the Space Shuttle Discovery lifts off from Launch Pad 39B on Mission STS-56 at 1:29:00 a.m., EDT, April 8. First attempt to launch Discovery on its 16th space voyage was halted at T-11 seconds on April 6. Aboard for the second Space Shuttle mission of 1993 are a crew of five and the Atmospheric Laboratory for Applications and Science 2 (ATLAS 2), the second in a series of missions to study the sun's energy output and Earth's middle atmosphere chemical makeup, and how these factors affect levels of ozone.

  20. Rehabilitation for the management of knee osteoarthritis using comprehensive traditional Chinese medicine in community health centers: study protocol for a randomized controlled trial.

    PubMed

    Yan, Hu; Su, Youxin; Chen, Lidian; Zheng, Guohua; Lin, Xueyi; Chen, Baojun; Zhou, Bihong; Zhang, Qing

    2013-11-04

    It is becoming increasingly necessary for community health centers to make rehabilitation services available to patients with osteoarthritis of the knee. However, for a number of reasons, including a lack of expertise, the small size of community health centers and the availability of only simple medical equipment, conventional rehabilitation therapy has not been widely used in China. Consequently, most patients with knee osteoarthritis seek treatment in high-grade hospitals. However, many patients cannot manage the techniques that they were taught in the hospital. Methods such as acupuncture, tuina, Chinese medical herb fumigation-washing and t'ai chi are easy to do and have been reported to have curative effects in those with knee osteoarthritis. To date, there have been no randomized controlled trials validating comprehensive traditional Chinese medicine for the rehabilitation of knee osteoarthritis in a community health center. Furthermore, there is no standard rehabilitation protocol using traditional Chinese medicine for knee osteoarthritis. The aim of the current study is to develop a comprehensive rehabilitation protocol using traditional Chinese medicine for the management of knee osteoarthritis in a community health center. This will be a randomized controlled clinical trial with blinded assessment. There will be a 4-week intervention utilizing rehabilitation protocols from traditional Chinese medicine and conventional therapy. Follow-up will be conducted for a period of 12 weeks. A total of 722 participants with knee osteoarthritis will be recruited. Participants will be randomly divided into two groups: experimental and control. Primary outcomes will include range of motion, girth measurement, the visual analogue scale, and results from the manual muscle, six-minute walking and stair-climbing tests. Secondary outcomes will include average daily consumption of pain medication, ability to perform daily tasks and health-related quality-of-life assessments

  1. Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Low back pain is a prevalent and debilitating condition that affects the health and quality of life of older adults. Older people often consult primary care physicians about back pain, with many also receiving concurrent care from complementary and alternative medicine providers, most commonly doctors of chiropractic. However, a collaborative model of treatment coordination between these two provider groups has yet to be tested. The primary aim of the Collaborative Care for Older Adults Clinical Trial is to develop and evaluate the clinical effectiveness and feasibility of a patient-centered, collaborative care model with family medicine physicians and doctors of chiropractic for the treatment of low back pain in older adults. Methods/design This pragmatic, pilot randomized controlled trial will enroll 120 participants, age 65 years or older with subacute or chronic low back pain lasting at least one month, from a community-based sample in the Quad-Cities, Iowa/Illinois, USA. Eligible participants are allocated in a 1:1:1 ratio to receive 12 weeks of medical care, concurrent medical and chiropractic care, or collaborative medical and chiropractic care. Primary outcomes are self-rated back pain and disability. Secondary outcomes include general and functional health status, symptom bothersomeness, expectations for treatment effectiveness and improvement, fear avoidance behaviors, depression, anxiety, satisfaction, medication use and health care utilization. Treatment safety and adverse events also are monitored. Participant-rated outcome measures are collected via self-reported questionnaires and computer-assisted telephone interviews at baseline, and at 4, 8, 12, 24, 36 and 52 weeks post-randomization. Provider-rated expectations for treatment effectiveness and participant improvement also are evaluated. Process outcomes are assessed through qualitative interviews with study participants and research clinicians, chart audits of progress notes and content

  2. Quantitative PET/CT scanner performance characterization based upon the society of nuclear medicine and molecular imaging clinical trials network oncology clinical simulator phantom.

    PubMed

    Sunderland, John J; Christian, Paul E

    2015-01-01

    The Clinical Trials Network (CTN) of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) operates a PET/CT phantom imaging program using the CTN's oncology clinical simulator phantom, designed to validate scanners at sites that wish to participate in oncology clinical trials. Since its inception in 2008, the CTN has collected 406 well-characterized phantom datasets from 237 scanners at 170 imaging sites covering the spectrum of commercially available PET/CT systems. The combined and collated phantom data describe a global profile of quantitative performance and variability of PET/CT data used in both clinical practice and clinical trials. Individual sites filled and imaged the CTN oncology PET phantom according to detailed instructions. Standard clinical reconstructions were requested and submitted. The phantom itself contains uniform regions suitable for scanner calibration assessment, lung fields, and 6 hot spheric lesions with diameters ranging from 7 to 20 mm at a 4:1 contrast ratio with primary background. The CTN Phantom Imaging Core evaluated the quality of the phantom fill and imaging and measured background standardized uptake values to assess scanner calibration and maximum standardized uptake values of all 6 lesions to review quantitative performance. Scanner make-and-model-specific measurements were pooled and then subdivided by reconstruction to create scanner-specific quantitative profiles. Different makes and models of scanners predictably demonstrated different quantitative performance profiles including, in some cases, small calibration bias. Differences in site-specific reconstruction parameters increased the quantitative variability among similar scanners, with postreconstruction smoothing filters being the most influential parameter. Quantitative assessment of this intrascanner variability over this large collection of phantom data gives, for the first time, estimates of reconstruction variance introduced into trials from allowing

  3. Effects of traditional Chinese medicine Shu Gan Jian Pi granules on patients with breast cancer and cancer-related fatigue: study protocol for a randomized controlled trial.

    PubMed

    Li, Chen; Yang, GuoWang; Yu, MingWei; Xu, YongMei; Xue, Na; Nan, Nan; Wang, XiaoMin

    2015-04-26

    Cancer-related fatigue (CRF) is a common and often long-lasting symptom for many breast cancer survivors. Evidence for its management is scarce. However, the Traditional Chinese Medicine (TCM) Shu Gan Jian Pi (SGJP) granules is an effective and practical therapy for CRF. We will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to determine whether the SGJP granules can effectively manage CRF. Breast cancer survivors experiencing fatigue within 5 years of primary treatment completion will be enrolled and randomly assigned to Group S (SGJP) or Group P (placebo). The primary outcome measures will include Revised Piper Fatigue Scale score. Outcome measures will be collected at baseline and at weeks 2, 4, and 8. This study's findings may contribute to the development of an effective intervention for CRF. Current controlled trials ISRCTN12702489 , 14 August, 2013.

  4. The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.

    PubMed

    Huang, Jia; Lin, Zhengkun; Wang, Qin; Liu, Feiwen; Liu, Jiao; Fang, Yunhua; Chen, Shanjia; Zhou, Xiaoxuan; Hong, Wenjun; Wu, Jinsong; Madrigal-Mora, Natalia; Zheng, Guohua; Yang, Shanli; Tao, Jing; Chen, Lidian

    2015-06-16

    Post-stroke cognitive impairment (PSCI) lessens quality of life, restricts the rehabilitation of stroke, and increases the social and economic burden stroke imposes on patients and their families. Therefore effective treatment is of paramount importance. However, the treatment of PSCI is very limited. The primary aim of this protocol is to propose a lower cost and more effective therapy, and to confirm the long-term effectiveness of a therapeutic regimen of Traditional Chinese Medicine (TCM) rehabilitation for PSCI. A prospective, multicenter, large sample, randomized controlled trial will be conducted. A total of 416 eligible patients will be recruited from seven inpatient and outpatient stroke rehabilitation units and randomly allocated into a therapeutic regimen of TCM rehabilitation group or cognitive training (CT) control group. The intervention period of both groups will last 12 weeks (30 minutes per day, five days per week). Primary and secondary outcomes will be measured at baseline, 12 weeks (at the end of the intervention), and 36 weeks (after the 24-week follow-up period). This protocol presents an objective design of a multicenter, large sample, randomized controlled trial that aims to put forward a lower cost and more effective therapy, and confirm the long-term effectiveness of a therapeutic regimen of TCM rehabilitation for PSCI through subjective and objective assessments, as well as highlight its economic advantages. This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-14004872 ) on 23 June 2014.

  5. Evidence-based medicine: quality and comparability of clinical trials investigating the efficacy of prostaglandin F(2α) for the treatment of bovine endometritis.

    PubMed

    Haimerl, Peggy; Arlt, Sebastian; Heuwieser, Wolfgang

    2012-08-01

    The objective of this study was to evaluate the quality and comparability of published literature, and to summarize the effect of prostaglandin F(2α) (PGF(2α)) for the treatment of endometritis. It has been postulated that there is a dearth of high-level evidence-based research results in veterinary medicine. Also, there is a marked variation in the quality of studies in veterinary and animal science. Post-partum uterine infections occur commonly in dairy cattle and are reported to have a negative impact on reproductive performance. A comprehensive literature search was conducted utilizing online databases revealing a total of 2723 references. After applying specific exclusion criteria, a total of 68 trials were eligible for further analysis. These articles were evaluated utilizing specific parameters listed in an evaluation form such as randomization and the involvement of control groups. The analysis revealed that more than half of the trials (51·5%) were at least 20 years old. Furthermore, we found that about one third (36·8%) of all trials were controlled and randomized, while 3 of those (4·4%) were also blinded. Of those trials which calculated a calving-to-conception interval (n=30), 50% of the authors claimed an improvement, which was statistically significant in 23·3% of the cases. We conclude that there is a wide discrepancy between research results investigating the efficacy of PGF(2α).

  6. NASA Launch Services Program Overview

    NASA Technical Reports Server (NTRS)

    Higginbotham, Scott

    2016-01-01

    The National Aeronautics and Space Administration (NASA) has need to procure a variety of launch vehicles and services for its unmanned spacecraft. The Launch Services Program (LSP) provides the Agency with a single focus for the acquisition and management of Expendable Launch Vehicle (ELV) launch services. This presentation will provide an overview of the LSP and its organization, approach, and activities.

  7. Voyager 1's Launch Vehicle

    NASA Image and Video Library

    1977-09-05

    The Titan/Centaur-6 launch vehicle was moved to Launch Complex 41 at Kennedy Space Center in Florida to complete checkout procedures in preparation for launch. The photo is dated January 1977. This launch vehicle carried Voyager 1 into space on September 5, 1977. https://photojournal.jpl.nasa.gov/catalog/PIA21739

  8. SPIDER Readied for Launch

    NASA Image and Video Library

    2015-01-22

    Prior to launch, the team laid out the parachute and hang lines in front of SPIDER, seen in the distance. The long-duration balloon that would carry SPIDER into the sky is attached to the end of the parachute shown here in the foreground. http://photojournal.jpl.nasa.gov/catalog/PIA19177

  9. NanoLaunch

    NASA Technical Reports Server (NTRS)

    Jones, Jonathan; Harris, Lawanna

    2015-01-01

    NASA's NanoLaunch effort will provide the framework to mature both Earth-to-orbit and on-orbit propulsion and avionics technologies while also providing affordable, dedicated access to low-Earth orbit for CubeSat-class payloads. The project will also serve as an early career personnel training opportunity with mentors to gain hands-on project experience.

  10. Expedition 23 Launch Day

    NASA Image and Video Library

    2010-04-01

    Expedition 23 Flight Engineer Tracy Caldwell Dyson performs the traditional door signing Friday, April 2, 2010 at the Cosmonaut Hotel in Baikonur, Kazakhstan. Caldwell Dyson was launched onboard the Soyuz rocket later that day with Expedition 23 Soyuz Commander Alexander Skvortsov and Flight Engineer Mikhail Kornienko on a mission to the International Space Station (ISS). Photo Credit: (NASA/Carla Cioffi)

  11. STS-120 launch

    NASA Image and Video Library

    2007-10-23

    STS120-S-025 (23 Oct. 2007) --- In the firing room at NASA's Kennedy Space Center, NASA Associate Administrator Chris Scolese and other managers watch the Space Shuttle Discovery launch of the STS-120 mission at 11:38 a.m. (EDT), Oct. 23, 2007. William Gerstenmaier is in right foreground. Photo credit: NASA/Bill Ingalls

  12. Expedition 8 Launch Briefing

    NASA Image and Video Library

    2003-10-12

    Backup Expedition 8 Commander Bill McArthur, left, and prime Expedition 8 Commander Michael Foale practice procedures with a satellite phone during final training at their crew quarters in Baikonur, Kazakhstan, Wednesday, Oct. 15, 2003, for launch on a Soyuz TMA-3 vehicle Oct. 18 to the International Space Station. Photo Credit (NASA/Bill Ingalls)

  13. Expedition 25 Launch

    NASA Image and Video Library

    2010-10-07

    Expedition 25 NASA Flight Engineer Scott Kelly of the U.S., left, Soyuz Commander Alexander Kaleri and Flight Engineer Oleg Skripochka, right, have their Russian Sokol suits prepared for launch by technicians at the Baikonur Cosmodrome in Kazakhstan, Friday, Oct. 8, 2010. (Photo Credit: NASA/Carla Cioffi)

  14. Expedition 25 Launch

    NASA Image and Video Library

    2010-10-07

    Expedition 25 crew members prepare to have their Russian Sokol Suits pressure checked at the Baikonur Cosmodrome in Kazakhstan on Friday, Oct. 8, 2010. Soyuz Commander Alexander Kaleri, NASA Flight Engineer Scott Kelly and Flight Engineer Oleg Skripochka launched in their Soyuz TMA-01M at 5:10 a.m. Friday morning. (Photo Credit: NASA/Carla Cioffi)

  15. Expedition 25 Launch

    NASA Image and Video Library

    2010-10-07

    Expedition 25 Soyuz Commander Alexander Kaleri awaits to have his Russian Sokol Suit pressure checked at the Baikonur Cosmodrome on Friday, Oct. 8, 2010 in Kazakhstan. Kaleri and fellow Expedition 25 crew members Flight Engineers Scott Kelly and Oleg Skripochka launched in their Soyuz TMA-01M at 5:10 a.m. Friday morning. (Photo Credit: NASA/Carla Cioffi)

  16. Expedition 25 Launch

    NASA Image and Video Library

    2010-10-07

    Expedition 25 Soyuz Commander Alexander Kaleri awaits to have his Russian Sokol Suit pressure checked at the Baikonur Cosmodrome on Friday, Oct. 8, 2010 in Baikonur, Kazakhstan. Kaleri and fellow Expedition 25 crew members Flight Engineers Scott Kelly and Oleg Skripochka launched in their Soyuz TMA-01M at 5:10 a.m. Friday morning. (Photo Credit: NASA/Carla Cioffi)

  17. Expedition 25 Launch

    NASA Image and Video Library

    2010-10-07

    Expedition 25 NASA Flight Engineer Scott Kelly of the U.S., left, and Soyuz Commander Alexander Kaleri have their Russian Sokol suits prepared for launch by technicians at the Baikonur Cosmodrome in Kazakhstan, Friday, Oct. 8, 2010. (Photo Credit: NASA/Carla Cioffi)

  18. Expedition 25 Launch

    NASA Image and Video Library

    2010-10-07

    Expedition 25 Flight Engineer Oleg Skripochka awaits to have his Russian Sokol Suit pressure checked at the Baikonur Cosmodrome on Friday, Oct. 8, 2010 in Kazakhstan. Skripochka, Soyuz Commander Alexander Kaleri and NASA Flight Engineer Scott Kelly launched in their Soyuz TMA-01M at 5:10 a.m. Friday morning. (Photo Credit: NASA/Carla Cioffi)

  19. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-20

    Expedition 22 Soyuz Commander Oleg Kotov of Russia smiles for photographers after performing the traditional door signing at the Cosmonaut Hotel in Baikonur, Kazakhstan before departing with fellow crew members, NASA Flight Engineer Timothy J. Creamer of the U.S., and Flight Engineer Soichi Noguchi of Japan to suit up for their launch, Sunday, Dec. 20, 2009. Photo Credit: (NASA/Bill Ingalls)

  20. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-20

    Expedition 22 Flight Engineer Soichi Noguchi of Japan smiles for photographers after performing the traditional door signing at the Cosmonaut Hotel in Baikonur, Kazakhstan before departing with fellow crew members, Soyuz Commander Oleg Kotov of Russia, and NASA Flight Engineer Timothy J. Creamer of the U.S. to suit up for their launch, Sunday, Dec. 20, 2009. Photo Credit: (NASA/Bill Ingalls)

  1. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-20

    Expedition 22 NASA Flight Engineer Timothy J. Creamer of the U.S. smiles for photographers after performing the traditional door signing at the Cosmonaut Hotel in Baikonur, Kazakhstan before departing with fellow crew members, Soyuz Commander Oleg Kotov of Russia, and Flight Engineer Soichi Noguchi of Japan to suit up for their launch, Sunday, Dec. 20, 2009. Photo Credit: (NASA/Bill Ingalls)

  2. The Personnel Launch System

    NASA Technical Reports Server (NTRS)

    Piland, William M.; Talay, Theodore A.; Stone, Howard W.

    1990-01-01

    NASA has begun to study candidate vehicles for manned access to space in support of the Space Station or other future missions requiring on-demand transportation of people to and from earth orbit. One such system, which would be used to complement the present Shuttle or an upgraded version, is the Personnel Launch System (PLS), which is envisioned as a reusable priority vehicle to place people and small payloads into orbit using an experimental launch vehicle. The design of the PLS is based on a Space Station crew changeout requirement whereby eight passengers and two crew members are flown to the station and a like number are returned within a 72 hour mission duration. Experimental and computational aerothermodynamic heating studies have been conducted using a new two-color thermographic technique that involved coating the model with a phosphor that radiates at varying color intensities as a function of temperature when illuminated with UV light. A full-scale model, the HL-20, has been produced and will be used for man-machine research. Three launch vehicle concepts are being considered, a Titan IV, the Advanced Launch System, and a Shuttle equipped with liquid rocket boosters.

  3. Expedition 8 Launch Day

    NASA Image and Video Library

    2003-10-18

    Expedition 8 Commander and NASA Science Officer Michael Foale smiles for the camera during the short bus ride to the launch pad for liftoff in a Soyuz TMA-3 vehicle to the International Space Station, Saturday, Oct. 18, 2003, at the Baikonur Cosmodrome, Kazakhstan. Photo Credit (NASA/Bill Ingalls)

  4. Expedition 8 Launch Briefing

    NASA Image and Video Library

    2003-10-12

    European Space Agency astronaut Pedro Duque of Spain listens to a briefing on mission activities from a Russian trainer at his crew quarters in Baikonur, Kazakhstan, Wednesday, Oct. 15, 2003 as he prepares for his launch to the International Space Station Oct. 18 in a Soyuz TMA-3 vehicle. Photo Credit (NASA/Bill Ingalls)

  5. AST Launch Vehicle Acoustics

    NASA Technical Reports Server (NTRS)

    Houston, Janice; Counter, D.; Giacomoni, D.

    2015-01-01

    The liftoff phase induces acoustic loading over a broad frequency range for a launch vehicle. These external acoustic environments are then used in the prediction of internal vibration responses of the vehicle and components which result in the qualification levels. Thus, predicting these liftoff acoustic (LOA) environments is critical to the design requirements of any launch vehicle. If there is a significant amount of uncertainty in the predictions or if acoustic mitigation options must be implemented, a subscale acoustic test is a feasible pre-launch test option to verify the LOA environments. The NASA Space Launch System (SLS) program initiated the Scale Model Acoustic Test (SMAT) to verify the predicted SLS LOA environments and to determine the acoustic reduction with an above deck water sound suppression system. The SMAT was conducted at Marshall Space Flight Center and the test article included a 5% scale SLS vehicle model, tower and Mobile Launcher. Acoustic and pressure data were measured by approximately 250 instruments. The SMAT liftoff acoustic results are presented, findings are discussed and a comparison is shown to the Ares I Scale Model Acoustic Test (ASMAT) results.

  6. Successful launch of SOHO

    NASA Astrophysics Data System (ADS)

    1995-12-01

    "Understanding how the Sun behaves is of crucial importance to all of us on Earth. It affects our everyday lives" said Roger Bonnet, Director of Science at ESA, who witnessed SOHO's spectacular nighttime launch from Cape Canaveral. "When SOHO begins work in four months time, scientists will, for the first time, be able to study this star 24 hours a day, 365 days a year". The 12 instruments on SOHO will probe the Sun inside out, from the star's very centre to the solar wind that blasts its way through the solar system. It will even listen to sounds, like musical notes, deep within the star by recording their vibrations when they reach the surface. SOHO was launched from Cape Canaveral Air Station, Florida, atop an Atlas IIAS rocket, at 09:08 CET on Saturday 2 December 1995. The 1.6 tonne observatory was released into its transfer orbit from the rocket's Centaur upper stage about two hours after launch. It will take four months for the satellite to reach its final position, a unique vantage point, located 1.5 million kilometres from Earth, where the gravitational pull of the Earth and Sun are equal. From here, the Lagrange point, SOHO will have an unobstructed view of the Sun all year round. SOHO's launch was delayed from 23 November because a flaw was discovered in a precision regulator, which throttles the power of the booster engine on the Atlas rocket. The system was replaced and retested before the launch. SOHO is a project of international cooperation between ESA and NASA. The spacecraft was designed and built in Europe, NASA provided the launch and will operate the satellite from its Goddard Space Flight Center, Maryland. European scientists provided eight of the observatory's instruments and US scientists a further three. The spacecraft is part of the international Solar-Terrestrial Science Programme, the next member of which is Cluster, a flotilla of four spacecraft that will study how the Sun affects Earth and surrounding space. Cluster is scheduled for

  7. Combination of flying needle with Chinese Herbal Medicine in the treatment of Atopic dermatitis: A clinical trial.

    PubMed

    X Quan, Xiaohong; Cheng, Shenrong; Ma, Hong; Huang, Hengxuan; Wang, Bin; Chen, Xiuhua

    2014-09-01

    Atopic dermatitis (Atopic dermatitis, AD) is a kind of chronic recurrent dermatitis. So far, no curative treatment has been found yet. Acupuncture, as a kind of alternative medicine, Flying Needle is a kind of acupuncture, which has a unique curative effectiveness in improving the skin lesion and itch. A single-center, prospective, randomized clinical design was conducted. The curative effect of the combination of Chinese herbal medicine and acupuncture for the treatment of Atopic dermatitis was assessed. Thirty (30) patients were treated with Flying Needle and Chinese herbal medicine. Because of personal reasons, one (1) dropped out. The patients accepted Flying Needle treatment 3 times a week and the internal medicine 3 times daily for in all 12 weeks. Before treatment, and after treat 4,8 and 12 weeks, assessments were performed. After treat 12 weeks, all patients of SCORAD score were dropped, with the mean SCORAD score declining to 19.58 ± 12.21. The recovery and removal rate comparison (*δx² = 5.28, P= 0.03<0.05). There are no side effects. The results hint that combine Flying Needle with Chinese herbal medicine are benefit on patients with atopic dermatitis and the effectiveness may better than oral medicine alone.

  8. A Randomized Clinical Trial on Treatment of Chronic Constipation by Traditional Persian Medicine Recommendations Compared to Allopathic Medicine: A Pilot Study

    PubMed Central

    Fattahi, Mohammad Reza; Alorizi, Seyed Morteza Emami; Nimrouzi, Majid; Zarshenas, Mohammad M.; Parvizi, Mohammad Mahdi

    2017-01-01

    Background: The aim of this study was to compare the efficacy and side effects of lactulose plus traditional Persian medicine with only lactulose on the functional chronic constipation. Methods: Participants included 20 patients (10 in each group) aged 18–80 years, with major inclusion criteria of ROME III. They were assigned into two parallel therapeutic groups, including the intervention group (lactulose plus traditional Persian medicine [TPM] advices) and control group (only lactulose) through a block randomization. Weekly follow-up was done for 1 month for both groups. Results: After the intervention, the frequency of bowel habit increased significantly in patients of both groups (P = 0.001), and the frequency of hard stool defecation, sensation of painful defecation, sensation of incomplete evacuation, sensation of anorectal obstruction, and manual maneuver for evacuation were decreased significantly in patients of both groups (P < 0.001 for all comparisons and 0.025 for manual maneuver). However, the only significant difference between the two groups was more reduction in the sensation of painful defecation in the lactulose group versus lactulose plus TPM advices (P = 0.014). Conclusions: Based on the pilot study, no significant difference was shown between TPM with lactulose and lactulose only in the management of chronic functional constipation. However, the easy recommendations of TPM can be useful in improving chronic constipation. PMID:28757927

  9. NLS Advanced Development - Launch operations

    NASA Technical Reports Server (NTRS)

    Parrish, Carrie L.

    1992-01-01

    Attention is given to Autonomous Launch Operations (ALO), one of a number of the USAF's National Launch System (NLS) Launch Operations projects whose aim is to research, develop and apply new technologies and more efficient approaches toward launch operations. The goal of the ALO project is to develop generic control and monitor software for launch operation subsystems. The result is enhanced reliability of system design, and reduced software development and retention of expert knowledge throughout the life-cycle of the system.

  10. Contracting and launching small satellites with the Rockot launch vehicle

    NASA Astrophysics Data System (ADS)

    Kinnersley, M.; Zorina, A.; Leclerc, J.

    2004-11-01

    Arranging secondary payload 'rides' with launch vehicles can be a lengthy and often frustrating process, especially with a shared or cluster launch with a multitude of customers that need to be coordinated. Eurockot's point of view on what can be done to improve this process is given. The objective is to initiate discussions within the community on how to improve access to launch services whilst mutually benefiting both the provider and end user. Eurockot is one of the most active launch service companies in the world for providing small satellite launch services. In 2003, Eurockot placed nine payloads into three different orbits during one launch, including the first Cubesats to be orbited. In particular the results of the most recent launches will be reported. The flexibility and capabilities of the Rockot launch vehicle for launching small satellites especially in the secondary or shared payloads sector will also be shown.

  11. Teaching evidence based medicine literature searching skills to medical students during the clinical years - a protocol for a randomised controlled trial.

    PubMed

    Ilic, Dragan; Tepper, Katrina; Misso, Marie

    2011-07-28

    Two of the key steps in evidence based medicine (EBM) are being able to construct a clinical question and effectively search the literature to source relevant information. No evidence currently exists that informs whether such skills should be taught to medical students during their pre-clinical years, or delivered to include both the pre-clinical and clinical years of study. This is an important component of curriculum design as the level of clinical maturity of students can affect their perception of the importance and uptake of EBM principles in practice. A randomised controlled trial will be conducted to identify the effectiveness of delivering a formal workshop in EBM literature searching skills to third year medical students entering their clinical years of study. The primary outcome of EBM competency in literature searching skills will be evaluated using the Fresno tool. This trial will provide novel information on the effectiveness of delivering a formal education workshop in evidence based medicine literature searching skills during the clinical years of study. The result of this study will also identify the impact of teaching EBM literature searching skills to medical students during the clinical years of study.

  12. Effects of the traditional Chinese medicine Yi Shen Jian Gu granules on aromatase inhibitor-associated musculoskeletal symptoms: a study protocol for a multicenter, randomized, controlled clinical trial

    PubMed Central

    2014-01-01

    Background Aromatase inhibitors (AIs) are widely used as an adjuvant endocrine treatment in postmenopausal women with early-stage breast cancer. One of the main adverse effects of AIs is musculoskeletal symptoms, which leads to a lower quality of life and poor adherence to AI treatment. To date, no effective management of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) has been developed. Methods/design To determine whether the traditional Chinese medicine Yi Shen Jian Gu granules could effectively manage AIMSS we will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients experiencing musculoskeletal symptoms after taking AIs will be enrolled and treated with traditional Chinese medicine or placebo for 12 weeks. The primary outcome measures include Brief Pain Inventory-Short Form, Western Ontario and McMaster Universities Osteoarthritis Index, and Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands, which will be obtained at baseline and at 4, 8, 12 and 24 weeks. Discussion The results of this study will provide a new strategy to help relieve AIMSS. Trial registration ISCTN: ISRCTN06129599 (assigned 14 August 2013). PMID:24885324

  13. Computer-based teaching is as good as face to face lecture-based teaching of evidence based medicine: a randomised controlled trial

    PubMed Central

    2007-01-01

    Background At postgraduate level evidence based medicine (EBM) is currently taught through tutor based lectures. Computer based sessions fit around doctors' workloads, and standardise the quality of educational provision. There have been no randomized controlled trials comparing computer based sessions with traditional lectures at postgraduate level within medicine. Methods This was a randomised controlled trial involving six postgraduate education centres in the West Midlands, U.K. Fifty five newly qualified foundation year one doctors (U.S internship equivalent) were randomised to either computer based sessions or an equivalent lecture in EBM and systematic reviews. The change from pre to post-intervention score was measured using a validated questionnaire assessing knowledge (primary outcome) and attitudes (secondary outcome). Results Both groups were similar at baseline. Participants' improvement in knowledge in the computer based group was equivalent to the lecture based group (gain in score: 2.1 [S.D = 2.0] versus 1.9 [S.D = 2.4]; ANCOVA p = 0.078). Attitudinal gains were similar in both groups. Conclusion On the basis of our findings we feel computer based teaching and learning is as effective as typical lecture based teaching sessions for educating postgraduates in EBM and systematic reviews. PMID:17659076

  14. Cassini launch contingency effort

    NASA Astrophysics Data System (ADS)

    Chang, Yale; O'Neil, John M.; McGrath, Brian E.; Heyler, Gene A.; Brenza, Pete T.

    2002-01-01

    On 15 October 1997 at 4:43 AM EDT, the Cassini spacecraft was successfully launched on a Titan IVB/Centaur on a mission to explore the Saturnian system. It carried three Radioisotope Thermoelectric Generators (RTGs) and 117 Light Weight Radioisotope Heater Units (LWRHUs). As part of the joint National Aeronautics and Space Administration (NASA)/U.S. Department of Energy (DoE) safety effort, a contingency plan was prepared to address the unlikely events of an accidental suborbital reentry or out-of-orbital reentry. The objective of the plan was to develop procedures to predict, within hours, the Earth impact footprints (EIFs) for the nuclear heat sources released during the atmospheric reentry. The footprint predictions would be used in subsequent notification and recovery efforts. As part of a multi-agency team, The Johns Hopkins University Applied Physics Laboratory (JHU/APL) had the responsibility to predict the EIFs of the heat sources after a reentry, given the heat sources' release conditions from the main spacecraft. (No ablation burn-through of the heat sources' aeroshells was expected, as a result of earlier testing.) JHU/APL's other role was to predict the time of reentry from a potential orbital decay. The tools used were a three degree-of-freedom trajectory code, a database of aerodynamic coefficients for the heat sources, secure links to obtain tracking data, and a high fidelity special perturbation orbit integrator code to predict time of spacecraft reentry from orbital decay. In the weeks and days prior to launch, all the codes and procedures were exercised. Notional EIFs were derived from hypothetical reentry conditions. EIFs predicted by JHU/APL were compared to those by JPL and US SPACECOM, and were found to be in good agreement. The reentry time from orbital decay for a booster rocket for the Russian Progress M-36 freighter, a cargo ship for the Mir space station, was predicted to within 5 minutes more than two hours before reentry. For the

  15. Patients' general satisfaction with telephone counseling by pharmacists and effects on satisfaction with information and beliefs about medicines: Results from a cluster randomized trial.

    PubMed

    Kooy, Marcel Jan; Van Geffen, Erica C G; Heerdink, Eibert R; Van Dijk, Liset; Bouvy, Marcel L

    2015-06-01

    Assess effects of pharmacists' counseling by telephone on patients' satisfaction with counseling, satisfaction with information and beliefs about medicines for newly prescribed medicines. A cluster randomized trial in Dutch community pharmacies. Patients ≥18 years were included when starting with antidepressants, bisphosphonates, RAS-inhibitors or statins. The intervention comprised counseling by telephone to address barriers to adherent behavior. It was supported by an interview protocol. Controls received usual care. Outcomes were effects on beliefs about medication, satisfaction with information and counseling. Data was collected with a questionnaire. Responses of 211 patients in nine pharmacies were analyzed. More intervention arm patients were satisfied with counseling (adj. OR 2.2 (95% CI 1.3, 3.6)). Patients with counseling were significantly more satisfied with information on 4 items, had less concerns and less frequently had a 'skeptical' attitude towards medication (adj. OR 0.5 (0.3-0.9)). Effects on most outcomes were more pronounced in men than in women. Telephone counseling by pharmacists improved satisfaction with counseling and satisfaction with information on some items. It had a small effect on beliefs about medicines. Pharmacists can use counseling by telephone, but more research is needed to find out which patients benefit most. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  16. A perfect launch

    NASA Technical Reports Server (NTRS)

    2000-01-01

    Billows of smoke and steam spread across Launch Pad 39A as Space Shuttle Discovery lifts off on mission STS-92 to the International Space Station. The perfect on-time liftoff occurred at 7:17 p.m. EDT, sending a crew of seven on the 100th launch in the history of the Shuttle program. Discovery carries a payload that includes the Integrated Truss Structure Z-1, first of 10 trusses that will form the backbone of the Space Station, and the third Pressurized Mating Adapter that will provide a Shuttle docking port for solar array installation on the sixth Station flight and Lab installation on the seventh Station flight. Discovery's landing is expected Oct. 22 at 2:10 p.m. EDT.

  17. STS-133 launch

    NASA Image and Video Library

    2011-02-24

    STS133-S-066 (24 Feb. 2011) --- In Firing Room 4 of the Launch Control Center at NASA's Kennedy Space Center in Florida, Shuttle Launch Director Mike Leinbach watches space shuttle Discovery head toward Earth orbit on the STS-133 mission to the International Space Station. Discovery and its six-member crew are on a mission to deliver the Permanent Multipurpose Module, packed with supplies and critical spare parts, as well as Robonaut 2, the dexterous humanoid astronaut helper, to the orbiting outpost. Discovery is making its 39th mission and is scheduled to be retired following STS-133. This is the 133rd Space Shuttle Program mission and the 35th shuttle voyage to the space station. Photo credit: NASA or National Aeronautics and Space Administration

  18. LAUNCH - STS-7 - KSC

    NASA Image and Video Library

    1983-06-18

    S83-35620 (18 June 1983) --- The space shuttle Challenger, its two solid rocket boosters and an external fuel tank carry the five-member STS-7 astronaut crew toward a six-day mission in Earth orbit. This high-angle view of the liftoff, a lengthy stretch of Florida Atlantic coastline and a number of large cumulus clouds was photographed with a handheld 70mm camera by astronaut John W. Young. Young usually pilots the Shuttle Training Aircraft (STA) for weather monitoring at launch and landing sites for STS missions. The Challenger?s second launch occurred at 7:33 a.m. (EDT) on 18 June 1983. Photo credit: NASA

  19. STS-121 Launch

    NASA Technical Reports Server (NTRS)

    2006-01-01

    Space Shuttle Discovery and its seven-member crew launched at 2:38 p.m. (EDT) to begin the two-day journey to the International Space Station (ISS) on the historic Return to Flight STS-121 mission. The shuttle made history as it was the first human-occupying spacecraft to launch on Independence Day. During its 12-day mission, this utilization and logistics flight delivered a multipurpose logistics module (MPLM) to the ISS with several thousand pounds of new supplies and experiments. In addition, some new orbital replacement units (ORUs) were delivered and stowed externally on the ISS on a special pallet. These ORUs are spares for critical machinery located on the outside of the ISS. During this mission the crew also carried out testing of Shuttle inspection and repair hardware, as well as evaluated operational techniques and concepts for conducting on-orbit inspection and repair.

  20. STS-116 Launch

    NASA Image and Video Library

    2006-12-09

    STS116-S-021 (9 Dec. 2006) --- Against a black night sky, the Space Shuttle Discovery and its seven-member crew head toward Earth-orbit and a scheduled link-up with the International Space Station. Liftoff from the Kennedy Space Center's launch pad 39B occurred at 8:47 p.m. (EST) on Dec. 9, 2006 in what was the first evening shuttle launch since 2002. The STS-116 crew will link up with the station on Monday, Dec. 11, to begin a complex, week-long stay that will rewire the outpost and increase its power supply. During three spacewalks and intricate choreography with ground controllers, the astronauts will bring electrical power on line generated by a giant solar array wing delivered to the station in September.

  1. STS-116 Launch

    NASA Image and Video Library

    2006-12-09

    STS116-S-009 (9 Dec. 2006) --- Against a black night sky, the Space Shuttle Discovery and its seven-member crew head toward Earth-orbit and a scheduled link-up with the International Space Station. Liftoff from the Kennedy Space Center's launch pad 39B occurred at 8:47 p.m. (EST) on Dec. 9, 2006 in what was the first evening shuttle launch since 2002. The STS-116 crew will link up with the station on Monday, Dec. 11, to begin a complex, week-long stay that will rewire the outpost and increase its power supply. During three spacewalks and intricate choreography with ground controllers, the astronauts will bring electrical power on line generated by a giant solar array wing delivered to the station in September.

  2. STS-116 Launch

    NASA Image and Video Library

    2006-12-09

    STS116-S-008 (9 Dec. 2006) --- Against a black night sky, the Space Shuttle Discovery and its seven-member crew head toward Earth-orbit and a scheduled link-up with the International Space Station. Liftoff from the Kennedy Space Center's launch pad 39B occurred at 8:47 p.m. (EST) on Dec. 9, 2006 in what was the first evening shuttle launch since 2002. The STS-116 crew will link up with the station on Monday, Dec. 11, to begin a complex, week-long stay that will rewire the outpost and increase its power supply. During three spacewalks and intricate choreography with ground controllers, the astronauts will bring electrical power on line generated by a giant solar array wing delivered to the station in September.

  3. STS-116 Launch

    NASA Image and Video Library

    2006-12-09

    STS116-S-011 (9 Dec. 2006) --- Against a black night sky, the Space Shuttle Discovery and its seven-member crew head toward Earth-orbit and a scheduled link-up with the International Space Station. Liftoff from the Kennedy Space Center's launch pad 39B occurred at 8:47 p.m. (EST) on Dec. 9, 2006 in what was the first evening shuttle launch since 2002. The STS-116 crew will link up with the station on Monday, Dec. 11, to begin a complex, week-long stay that will rewire the outpost and increase its power supply. During three spacewalks and intricate choreography with ground controllers, the astronauts will bring electrical power on line generated by a giant solar array wing delivered to the station in September.

  4. STS-116 Launch

    NASA Image and Video Library

    2006-12-09

    STS116-S-016 (9 Dec. 2006) --- Against a black night sky, the Space Shuttle Discovery and its seven-member crew head toward Earth-orbit and a scheduled link-up with the International Space Station. Liftoff from the Kennedy Space Center's launch pad 39B occurred at 8:47 p.m. (EST) on Dec. 9, 2006 in what was the first evening shuttle launch since 2002. The STS-116 crew will link up with the station on Monday, Dec. 11, to begin a complex, week-long stay that will rewire the outpost and increase its power supply. During three spacewalks and intricate choreography with ground controllers, the astronauts will bring electrical power on line generated by a giant solar array wing delivered to the station in September.

  5. STS-116 Launch

    NASA Image and Video Library

    2006-12-09

    STS116-S-014 (9 Dec. 2006) --- Against a black night sky, the Space Shuttle Discovery and its seven-member crew head toward Earth-orbit and a scheduled link-up with the International Space Station. Liftoff from the Kennedy Space Center's launch pad 39B occurred at 8:47 p.m. (EST) on Dec. 9, 2006 in what was the first evening shuttle launch since 2002. The STS-116 crew will link up with the station on Monday, Dec. 11, to begin a complex, week-long stay that will rewire the outpost and increase its power supply. During three spacewalks and intricate choreography with ground controllers, the astronauts will bring electrical power on line generated by a giant solar array wing delivered to the station in September.

  6. STS-116 Launch

    NASA Image and Video Library

    2006-12-09

    STS116-S-018 (9 Dec. 2006) --- Against a black night sky, the Space Shuttle Discovery and its seven-member crew head toward Earth-orbit and a scheduled link-up with the International Space Station. Liftoff from the Kennedy Space Center's launch pad 39B occurred at 8:47 p.m. (EST) on Dec. 9, 2006 in what was the first evening shuttle launch since 2002. The STS-116 crew will link up with the station on Monday, Dec. 11, to begin a complex, week-long stay that will rewire the outpost and increase its power supply. During three spacewalks and intricate choreography with ground controllers, the astronauts will bring electrical power on line generated by a giant solar array wing delivered to the station in September.

  7. STS-116 Launch

    NASA Image and Video Library

    2006-12-09

    STS116-S-010 (9 Dec. 2006) --- Against a black night sky, the Space Shuttle Discovery and its seven-member crew head toward Earth-orbit and a scheduled link-up with the International Space Station. Liftoff from the Kennedy Space Center's launch pad 39B occurred at 8:47 p.m. (EST) on Dec. 9, 2006 in what was the first evening shuttle launch since 2002. The STS-116 crew will link up with the station on Monday, Dec. 11, to begin a complex, week-long stay that will rewire the outpost and increase its power supply. During three spacewalks and intricate choreography with ground controllers, the astronauts will bring electrical power on line generated by a giant solar array wing delivered to the station in September.

  8. Traditional Herbal Medicine: A Review of Potential of Inhibitory Hepatocellular Carcinoma in Basic Research and Clinical Trial

    PubMed Central

    Wang, Zhidong; Li, Jun; Ji, Yuanyuan; An, Peng; Zhang, Shu; Li, Zongfang

    2013-01-01

    Although significantly develops in hepatocellular carcinoma (HCC), features of HCC remain an aggressive cancer with a dismal outcome. Traditional Chinese medicine (TCM), specifically Chinese herbal medicine (CHM), is one of the most popular complementary and alternative medicine modalities worldwide. The use of heat-clearing and detoxicating (Chinese named qingre jiedu) CHM has attracted great attention as an alternative antitumor including HCC considering its low toxicity and high activity. Together these reports indicate that CHM is a promising anti-HCC herbal remedy in basic research. For patients with advanced HCC, CHM including formula and single combined with transcatheter arterial chemoembolization or chemotherapy is able to decrease tumor growth and the side effect of toxicity and improve overall survival, quality of life, and immune function. Due to its abundance, low cost, and safety in consumption, CHM remains a species with tremendous potential for further investigation in HCC. PMID:23956767

  9. Expedition 11 Launch Day

    NASA Image and Video Library

    2005-04-15

    Unidentified family members of NASA astronaut John Phillips waves offers up best wishes for a safe mission and a happy birthday prior to launch, Friday, April 15, 2005, aboard the Soyuz TMA-6 spacecraft from the Baikonur Cosmodrome in Kazakhstan for a two-day trip to the International Space Station where he will spend six months living in space. Photo Credit: (NASA/Bill Ingalls)

  10. Space Shuttle Discovery Launch

    NASA Image and Video Library

    2011-02-24

    NASA Administrator Charles Bolden and other NASA management watch the launch of space shuttle Discovery (STS-133) from the firing room at Kennedy Space Center, Thursday, Feb. 24, 2011, in Cape Canaveral, Fla. Discovery, on its 39th and final flight, is carrying the Italian-built Permanent Multipurpose Module (PMM), Express Logistics Carrier 4 (ELC4) and Robonaut 2, the first humanoid robot in space to the International Space Station. Photo Credit: (NASA/Bill Ingalls)

  11. Space Shuttle Discovery Launch

    NASA Image and Video Library

    2011-02-24

    NASA management watch the launch of space shuttle Discovery (STS-133) from the firing room at Kennedy Space Center, Thursday, Feb. 24, 2011, in Cape Canaveral, Fla. Discovery, on its 39th and final flight, is carrying the Italian-built Permanent Multipurpose Module (PMM), Express Logistics Carrier 4 (ELC4) and Robonaut 2, the first humanoid robot in space to the International Space Station. Photo Credit: (NASA/Bill Ingalls)

  12. Expendable launch vehicle propulsion

    NASA Technical Reports Server (NTRS)

    Fuller, Paul N.

    1991-01-01

    The current status is reviewed of the U.S. Expendable Launch Vehicle (ELV) fleet, the international competition, and the propulsion technology of both domestic and foreign ELVs. The ELV propulsion technology areas where research, development, and demonstration are most needed are identified. These propulsion technology recommendations are based on the work performed by the Commercial Space Transportation Advisory Committee (COMSTAC), an industry panel established by the Dept. of Transportation.

  13. Launch of Zoological Letters.

    PubMed

    Fukatsu, Takema; Kuratani, Shigeru

    2016-02-01

    A new open-access journal, Zoological Letters, was launched as a sister journal to Zoological Science, in January 2015. The new journal aims at publishing topical papers of high quality from a wide range of basic zoological research fields. This review highlights the notable reviews and research articles that have been published in the first year of Zoological Letters, providing an overview on the current achievements and future directions of the journal.

  14. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-21

    Expedition 22 NASA Flight Engineer Timothy J. Creamer of the U.S. prepares to have his Russian Sokol suit pressure checked at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Monday, Dec. 21, 2009. Creamer and fellow Expedition 22 crew members, Soyuz Commander Oleg Kotov of Russia, and Flight Engineer Soichi Noguchi of Japan launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  15. Expedition 24 Launch Day

    NASA Image and Video Library

    2010-06-14

    Expedition 24 Flight Engineer Doug Wheelock has his Russian Sokol suit pressure checked at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Tuesday, June 15, 2010. Wheelock and fellow Expedition 24 crew members Flight Engineer Shannon Walker and Soyuz Commander Fyodor Yurchikhin launched in their Soyuz TMA-19 rocket from the Baikonur Cosmodrome in Kazakhstan on Wednesday, June 16, 2010 at 3:35 a.m. Kazakhstan time. (Photo Credit: NASA/Carla Cioffi)

  16. Expedition 23 Launch Day

    NASA Image and Video Library

    2010-04-01

    Expedition 23 NASA Flight Engineer Tracy Caldwell Dyson of the U.S. prepares to have her Russian Sokol suit pressure checked at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Friday, April 2, 2010. Caldwell Dyson and fellow Expedition 23 crewmembers Soyuz Commander Alexander Skvortsov and Flight Engineer Mikhail Kornienko of Russia launched in their Soyuz TMA-18 rocket from the Baikonur Cosmodrome in Kazakhstan on Friday, April 2, 2010. Photo Credit: (NASA/Carla Cioffi)

  17. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-21

    Expedition 22 NASA Flight Engineer Timothy J. Creamer of the U.S. waves after having his Russian Sokol suit pressure checked at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Monday, Dec. 21, 2009. Creamer and fellow Expedition 22 crew members, Soyuz Commander Oleg Kotov of Russia, and Flight Engineer Soichi Noguchi of Japan launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  18. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-21

    Expedition 22 NASA Flight Engineer Timothy J. Creamer of the U.S. has his Russian Sokol suit pressure checked at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Monday, Dec. 21, 2009. Creamer and fellow Expedition 22 crew members, Soyuz Commander Oleg Kotov of Russia, and Flight Engineer Soichi Noguchi of Japan launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  19. Expedition 23 Launch Day

    NASA Image and Video Library

    2010-04-01

    Expedition 23 Soyuz Commander Alexander Skvortsov has his Russian Sokol suit pressure checked at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Friday, April 2, 2010. Skvortsov and fellow Expedition 23 crew members Flight Engineer Mikhail Kornienko of Russia and NASA Flight Engineer Tracy Caldwell Dyson launched in their Soyuz TMA-18 rocket from the Baikonur Cosmodrome in Kazakhstan on Friday, April 2, 2010. Photo Credit: (NASA/Carla Cioffi)

  20. Expedition 23 Launch Day

    NASA Image and Video Library

    2010-04-01

    Expedition 23 Flight Engineer Mikhail Kornienko of Russia prepares to have his Russian Sokol suit pressure checked at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Friday, April 2, 2010. Kornienko and fellow Expedition 23 crewmembers Soyuz Commander Alexander Skvortsov and NASA Flight Engineer Tracy Caldwell Dyson launched in their Soyuz TMA-18 rocket from the Baikonur Cosmodrome in Kazakhstan on Friday, April 2, 2010. Photo Credit: (NASA/Carla Cioffi)

  1. Expedition 24 Launch Day

    NASA Image and Video Library

    2010-06-14

    Expedition 24 Flight Engineer Shannon Walker has her Russian Sokol suit pressure checked at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Tuesday, June 15, 2010. Walker and fellow Expedition 24 crew members Flight Engineers Doug Wheelock and Soyuz Commander Fyodor Yurchikhin launched in their Soyuz TMA-19 rocket from the Baikonur Cosmodrome in Kazakhstan on Wednesday, June 16, 2010 at 3:35 a.m. Kazakhstan time. (Photo Credit: NASA/Carla Cioffi)

  2. Expedition 23 Launch Day

    NASA Image and Video Library

    2010-04-01

    Expedition 23 Flight Engineer Mikhail Kornienko of Russia has his Russian Sokol suit pressure checked at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Friday, April 2, 2010. Kornienko and fellow Expedition 23 crewmembers Soyuz Commander Alexander Skvortsov and NASA Flight Engineer Tracy Caldwell Dyson launched in their Soyuz TMA-18 rocket from the Baikonur Cosmodrome in Kazakhstan on Friday, April 2, 2010. Photo Credit: (NASA/Bill Ingalls)

  3. Expedition 19 Launch Day

    NASA Image and Video Library

    2009-03-25

    The prime and backup crew buses drive under police escort to building 254 of the Baikonur Cosmodrome where Expedition 19 Commander Gennady I. Padalka, Flight Engineer Michael R. Barratt and Spaceflight Participant Charles Simonyi will don their Russian Sokol suits in preparation for their Soyuz launch to the International Space Station on Thursday, March 26, 2009 in Baikonur, Kazakhstan. (Photo Credit: NASA/Bill Ingalls)

  4. Space Probe Launch

    NASA Technical Reports Server (NTRS)

    1970-01-01

    Managed by Marshall Space Flight Center, the Space Tug was a reusable multipurpose space vehicle designed to transport payloads to different orbital inclinations. Utilizing mission-specific combinations of its three primary modules (crew, propulsion, and cargo) and a variety of supplementary kits, the Space Tug was capable of numerous space applications. This 1970 artist's concept depicts the Tug's propulsion module launching a space probe into lunar orbit.

  5. Space Shuttle Endeavour launch

    NASA Technical Reports Server (NTRS)

    1992-01-01

    A smooth countdown culminated in a picture-perfect launch as the Space Shuttle Endeavour (STS-47) climbed skyward atop a ladder of billowing smoke. Primary payload for the plarned seven-day flight was Spacelab-J science laboratory. The second flight of Endeavour marks a number of historic firsts: the first space flight of an African-American woman, the first Japanese citizen to fly on a Space Shuttle, and the first married couple to fly in space.

  6. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-21

    Expedition 22 Soyuz Commander Oleg Kotov of Russia, bottom, NASA Flight Engineer Timothy J. Creamer of the U.S., center, and Flight Engineer Soichi Noguchi of Japan wave farewell from the bottom of the soyuz rocket at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Monday, Dec. 21, 2009. Kotov, Creamer and Noguchi launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  7. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-21

    The Soyuz TMA-17 rocket is seen moments after Expedition 22 Soyuz Commander Oleg Kotov of Russia, NASA Flight Engineer Timothy J. Creamer of the U.S., and Flight Engineer Soichi Noguchi of Japan boarded the spacecraft at the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. Kotov, Creamer and Noguchi launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  8. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-20

    Expedition 22 Flight Engineer Soichi Noguchi of Japan prepares to have his Russian Sokol suit pressure checked at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Sunday, Dec. 20, 2009. Soichi and fellow Expedition 22 crew members NASA Flight Engineer Timothy J. Creamer of the U.S., Soyuz Commander Oleg Kotov of Russia launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  9. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-21

    The Soyuz TMA-17 rocket is seen several hours before its launch from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. The Soyuz rocket will carry Expedition 22 NASA Flight Engineer Timothy J. Creamer of the U.S., Soyuz Commander Oleg Kotov of Russia and Flight Engineer Soichi Noguchi of Japan to the International Space Station. (Photo Credit: NASA/Bill Ingalls)

  10. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-20

    Expedition 22 Soyuz Commander Oleg Kotov of Russia, seated left, dons his Russian Sokol as Flight Engineer Soichi Noguchi of Japan, seated right, looks on at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Sunday, Dec. 20, 2009. Kotov, Noguchi and NASA Flight Engineer Timothy J. Creamer of the U.S. launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  11. Reflexive Launch Strategies.

    DTIC Science & Technology

    1980-06-01

    ballistic-missile submarines, would cause 16.3 million fatalities.... 15 The problem of analyzing the potential vulnerability of U.S. land-based ICBMs...problems, are the main deficiencies of the system. Among the princi- pal advantages of standard ICBMs are autonomy after launch and relative simplicity...have looked at this problem agree that once we make it an accepted or standard procedure to fire ICBMs on warning, it begins to get very easy to write

  12. Space Logistics: Launch Capabilities

    NASA Technical Reports Server (NTRS)

    Furnas, Randall B.

    1989-01-01

    The current maximum launch capability for the United States are shown. The predicted Earth-to-orbit requirements for the United States are presented. Contrasting the two indicates the strong National need for a major increase in Earth-to-orbit lift capability. Approximate weights for planned payloads are shown. NASA is studying the following options to meet the need for a new heavy-lift capability by mid to late 1990's: (1) Shuttle-C for near term (include growth versions); and (2) the Advanced Lauching System (ALS) for the long term. The current baseline two-engine Shuttle-C has a 15 x 82 ft payload bay and an expected lift capability of 82,000 lb to Low Earth Orbit. Several options are being considered which have expanded diameter payload bays. A three-engine Shuttle-C with an expected lift of 145,000 lb to LEO is being evaluated as well. The Advanced Launch System (ALS) is a potential joint development between the Air Force and NASA. This program is focused toward long-term launch requirements, specifically beyond the year 2000. The basic approach is to develop a family of vehicles with the same high reliability as the Shuttle system, yet offering a much greater lift capability at a greatly reduced cost (per pound of payload). The ALS unmanned family of vehicles will provide a low end lift capability equivalent to Titan IV, and a high end lift capability greater than the Soviet Energia if requirements for such a high-end vehicle are defined.In conclusion, the planning of the next generation space telescope should not be constrained to the current launch vehicles. New vehicle designs will be driven by the needs of anticipated heavy users.

  13. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-20

    Expedition 22 Soyuz Commander Oleg Kotov of Russia listens to an audio check on his headset after donning his Russian Sokol suit at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Sunday, Dec. 20, 2009. Kotov and fellow Expedition 22 crew members, NASA Flight Engineer Timothy J. Creamer of the U.S., and Flight Engineer Soichi Noguchi of Japan launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  14. Expedition 8 Launch Day

    NASA Image and Video Library

    2003-10-18

    Expedition 8 Soyuz Commander Alexander Kaleri, left foreground, European Space Agency astronaut Pedro Duque of Spain and Expedition 8 Commander and NASA Science Officer Michael Foale walk to a bus at the Baikonur Cosmodrome in Kazakhstan, Saturday, Oct. 18, 2003, for transportation to the launch pad to liftoff in a Soyuz TMA-3 vehicle to the International Space Station. The trio arrived at the ISS Oct. 20. Photo Credit (NASA/Bill Ingalls)

  15. Expedition 8 Launch Day

    NASA Image and Video Library

    2003-10-18

    Expedition 8 Soyuz Commander Alexander Kaleri, left, European Space Agency astronaut Pedro Duque of Spain and Expedition 8 Commander and NASA Science Officer Michael Foale, right, prepare to board a bus at the Baikonur Cosmodrome in Kazakhstan, Saturday, Oct. 18, 2003, for transportation to the launch pad to liftoff in a Soyuz TMA-3 vehicle to the International Space Station. The trio arrived at the ISS Oct. 20. Photo Credit (NASA/Bill Ingalls)

  16. Expedition 8 Launch Day

    NASA Image and Video Library

    2003-10-18

    European Space Agency astronaut Pedro Duque of Spain, bottom, Expedition 8 Soyuz Commander Alexander Kaleri, top and Expedition 8 Commander and NASA Science Officer Michael Foale, receive final well wishes from Russian and U.S. officials at the base of the Soyuz rocket at the Baikonur Cosmodrome in Kazakhstan, Saturday, Oct. 18, 2003. The trio were launched on a Soyuz TMA-3 vehicle to the International Space Station, arriving on Oct. 20. Photo Credit (NASA/Bill Ingalls)

  17. Expedition 8 Launch Briefing

    NASA Image and Video Library

    2003-10-12

    Expedition 8 Commander and NASA Science Officer Michael Foale talks to a colleague on his cell phone from his crew quarters at the Cosmonaut Hotel in Baikonur, Kazakhstan, Wednesday, Oct. 15, 2003. Foale along with Expedition 8 Soyuz Commander Alexander Kaleri and European Space Agency astronaut Pedro Duuque of Spain, launched on a Soyuz TMA-3 vehicle to the International Space Station. Photo Credit (NASA/Bill Ingalls)

  18. Space Logistics: Launch Capabilities

    NASA Technical Reports Server (NTRS)

    Furnas, Randall B.

    1989-01-01

    The current maximum launch capability for the United States are shown. The predicted Earth-to-orbit requirements for the United States are presented. Contrasting the two indicates the strong National need for a major increase in Earth-to-orbit lift capability. Approximate weights for planned payloads are shown. NASA is studying the following options to meet the need for a new heavy-lift capability by mid to late 1990's: (1) Shuttle-C for near term (include growth versions); and (2) the Advanced Lauching System (ALS) for the long term. The current baseline two-engine Shuttle-C has a 15 x 82 ft payload bay and an expected lift capability of 82,000 lb to Low Earth Orbit. Several options are being considered which have expanded diameter payload bays. A three-engine Shuttle-C with an expected lift of 145,000 lb to LEO is being evaluated as well. The Advanced Launch System (ALS) is a potential joint development between the Air Force and NASA. This program is focused toward long-term launch requirements, specifically beyond the year 2000. The basic approach is to develop a family of vehicles with the same high reliability as the Shuttle system, yet offering a much greater lift capability at a greatly reduced cost (per pound of payload). The ALS unmanned family of vehicles will provide a low end lift capability equivalent to Titan IV, and a high end lift capability greater than the Soviet Energia if requirements for such a high-end vehicle are defined.In conclusion, the planning of the next generation space telescope should not be constrained to the current launch vehicles. New vehicle designs will be driven by the needs of anticipated heavy users.

  19. Expedition 50 Soyuz Launch

    NASA Image and Video Library

    2016-11-18

    nhq201611180002 (Nov. 18, 2016) --- In this one second exposure photograph, the Soyuz MS-03 spacecraft is seen launching from the Baikonur Cosmodrome with Expedition 50 crewmembers NASA astronaut Peggy Whitson, Russian cosmonaut Oleg Novitskiy of Roscosmos, and ESA astronaut Thomas Pesquet from the Baikonur Cosmodrome in Kazakhstan, Friday, Nov. 18, 2016, (Kazakh time) (Nov 17 Eastern time). Whitson, Novitskiy, and Pesquet will spend approximately six months on the orbital complex. Photo Credit: (NASA/Bill Ingalls)

  20. STS-129 Atlantis Launch

    NASA Image and Video Library

    2009-11-16

    Guests at NASA's Kennedy Space Center view the launch of space shuttle Atlantis in Cape Canaveral, Fla., on Monday, Nov. 16, 2009. Space shuttle Atlantis and its six-member crew began the 11-day STS-129 mission to the International Space Station. The shuttle will transport spare hardware to the outpost and return a station crew member who spent more than two months in space. Photo Credit: (NASA/Carla Cioffi)

  1. Outcome reporting among drug trials registered in ClinicalTrials.gov.

    PubMed

    Bourgeois, Florence T; Murthy, Srinivas; Mandl, Kenneth D

    2010-08-03

    Clinical trial registries are in widespread use to promote transparency around trials and their results. To describe characteristics of drug trials listed in ClinicalTrials.gov and examine whether the funding source of these trials is associated with favorable published outcomes. An observational study of safety and efficacy trials for anticholesteremics, antidepressants, antipsychotics, proton-pump inhibitors, and vasodilators conducted between 2000 and 2006. ClinicalTrials.gov, a Web-based registry of clinical trials launched in 1999. Publications resulting from the trials for the 5 drug categories of interest were identified, and data were abstracted on the trial record and publication, including timing of registration, elements of the study design, funding source, publication date, and study outcomes. Assessments were based on the primary funding categories of industry, government agencies, and nonprofit or nonfederal organizations. Among 546 drug trials, 346 (63%) were primarily funded by industry, 74 (14%) by government sources, and 126 (23%) by nonprofit or nonfederal organizations. Trials funded by industry were more likely to be phase 3 or 4 trials (88.7%; P < 0.001 across groups), to use an active comparator in controlled trials (36.8%; P = 0.010 across groups), to be multicenter (89.0%; P < 0.001 across groups), and to enroll more participants (median sample size, 306 participants; P < 0.001 across groups). Overall, 362 (66.3%) trials had published results. Industry-funded trials reported positive outcomes in 85.4% of publications, compared with 50.0% for government-funded trials and 71.9% for nonprofit or nonfederal organization-funded trials (P < 0.001). Trials funded by nonprofit or nonfederal sources with industry contributions were also more likely to report positive outcomes than those without industry funding (85.0% vs. 61.2%; P = 0.013). Rates of trial publication within 24 months of study completion ranged from 32.4% among industry-funded trials

  2. Research-design issues in cancer-symptom-management trials using complementary and alternative medicine: lessons from the National Cancer Institute Community Clinical Oncology Program experience.

    PubMed

    Buchanan, David R; White, Jeffrey D; O'Mara, Ann M; Kelaghan, Joseph W; Smith, Wendy B; Minasian, Lori M

    2005-09-20

    To identify major research-design issues in proposals submitted by investigators in the Community Clinical Oncology Program (CCOP) for clinical trials of complementary and alternative medicine (CAM) for cancer-symptom management. We conducted content analysis of all scientific reviews of concepts and protocols submitted by the CCOP to the National Cancer Institute (NCI) to identify research challenges in conducting clinical trials designed to evaluate CAM interventions for cancer-symptom management. Since the inception of the NCI Office of Cancer Complementary and Alternative Medicine in 1998, a total of 46 symptom-management studies using CAM interventions have been proposed by CCOP investigators, with 20 studies now in progress comprising 22% of the current total CCOP symptom-management portfolio. Proposals fell into four categories: complex natural products; nutritional therapeutics; mind-body interventions; and alternative medical systems. The most significant research-design issues arose as a consequence of the lack of preclinical data for CAM interventions and the lack of quality-control standards comparable with those used in regulating new pharmaceutical agents. Across the different types of CAM interventions, the most common problems found in proposed research designs are related to unwarranted assumptions about the consistency and standardization of CAM interventions, the need for data-based justifications for the study hypotheses, and the need to implement appropriate quality control and monitoring procedures during the course of the trial. To advance the state of the science, future research must address these critical issues if CAM interventions are to be evaluated rigorously and have a consequent impact on clinical practice and general public awareness.

  3. Launch Control Network Engineer

    NASA Technical Reports Server (NTRS)

    Medeiros, Samantha

    2017-01-01

    The Spaceport Command and Control System (SCCS) is being built at the Kennedy Space Center in order to successfully launch NASA’s revolutionary vehicle that allows humans to explore further into space than ever before. During my internship, I worked with the Network, Firewall, and Hardware teams that are all contributing to the huge SCCS network project effort. I learned the SCCS network design and the several concepts that are running in the background. I also updated and designed documentation for physical networks that are part of SCCS. This includes being able to assist and build physical installations as well as configurations. I worked with the network design for vehicle telemetry interfaces to the Launch Control System (LCS); this allows the interface to interact with other systems at other NASA locations. This network design includes the Space Launch System (SLS), Interim Cryogenic Propulsion Stage (ICPS), and the Orion Multipurpose Crew Vehicle (MPCV). I worked on the network design and implementation in the Customer Avionics Interface Development and Analysis (CAIDA) lab.

  4. Educational intervention on medication reviews aiming to reduce acute healthcare consumption in elderly patients with potentially inappropriate medicines-A pragmatic open-label cluster-randomized controlled trial in primary care.

    PubMed

    Schmidt-Mende, K; Andersen, M; Wettermark, B; Hasselström, J

    2017-08-11

    Potentially inappropriate medicines (PIMs) may cause 10% of unplanned admissions in elderly people. We performed an educational intervention in primary care to reduce acute health care consumption and PIMs through the promotion of medication reviews (MRs) in elderly patients. This cluster-randomized controlled trial was conducted in the context of an official campaign promoting rational drug use in elderly people. Sixty-nine primary health care practices with 119,910 patients aged older than or equal to 65 were randomized, with 1 dropout in the intervention group. The intervention consisted of educational outreach visits with feedback on prescribing and the development of a working procedure on MRs. Follow-up was 9 months. Outcomes were assessed in an administrative health care database. The combined primary outcome was unplanned hospital admission and/or emergency department visit. Secondary outcomes were among other PIMs and rates of MRs. The risk differences in outcomes between intervention and control group were estimated by using regression models. During follow-up, 22.8% of patients in the intervention and 22.0% in the control group were admitted unplanned to hospital and/or experienced at least 1 emergency department (nonsignificant risk difference 0.8%, 95% CI -0.7% to 2.4%). There were no significant differences regarding secondary outcomes such as PIMs or MRs. No changes were seen in acute health care consumption, PIMs, and MRs in elderly patients after an educational intervention in primary care. The reasons for the lack of effect could be a suboptimal intervention, limitations in outcome measures, and the use of administrative data to monitor outcomes. KEY POINTS We evaluated the implementation methods of an officially launched campaign to stimulate medication reviews in primary care presupposed by policymakers to be effective. The prevalence of potentially inappropriate medicines was analysed in official registers accounting for an unbiased analysis

  5. 32. Launch Control Center, commander's console. Note launch key at ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    32. Launch Control Center, commander's console. Note launch key at right. Lyon - Whiteman Air Force Base, Oscar O-1 Minuteman Missile Alert Facility, Southeast corner of Twelfth & Vendenberg Avenues, Knob Noster, Johnson County, MO

  6. Launch window extensions and launch opportunities for Navstar GPS

    NASA Astrophysics Data System (ADS)

    Vaughan, Scott H.; Mullikin, Thomas L.

    The original nine minute launch window for Navstar Global Positioning System vehicles allowed a very limited capability to overcome problems late in the countdown sequence. A longer launch window was desired in order to minimize the chance of an aborted launch attempt. However, the methods used to determine the original launch window could not provide an extended window without producing a conflict with the tight tolerances required for the final orbit plane. By taking full advantage of the dynamics and geometry of the plane change maneuver, we have developed a launch window definition that will provide as much as a 32 minute window. This definition maintains tight orbit plane tolerances and identifies all possible launch opportunities. The extended launch window has been in use since the eighth Navstar launch and has been highly successful.

  7. Russian Soyuz in Launch Position

    NASA Technical Reports Server (NTRS)

    2000-01-01

    The Soyuz TM-31 launch vehicle is shown in the vertical position for its launch from Baikonur, carrying the first resident crew to the International Space Station. The Russian Soyuz launch vehicle is an expendable spacecraft that evolved out of the original Class A (Sputnik). From the early 1960s until today, the Soyuz launch vehicle has been the backbone of Russia's marned and unmanned space launch fleet. Today, the Soyuz launch vehicle is marketed internationally by a joint Russian/French consortium called STARSEM. As of August 2001, there have been ten Soyuz missions under the STARSEM banner.

  8. Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion, part 2: data extrapolation, trial design, and pharmacokinetics.

    PubMed

    Sun, Haihao; Vesely, Richard; Nelson, Robert M; Taminiau, Jan; Szitanyi, Peter; Isaac, Maria; Klein, Agnes; Uzu, Shinobu; Griebel, Donna; Mulberg, Andrew E

    2014-06-01

    To facilitate global drug development, the International Pediatric Inflammatory Bowel Disease Working Group (i-IBD Working Group) discussed data extrapolation, trial design, and pharmacokinetic (PK) considerations for drugs intended to treat pediatric ulcerative colitis (UC), and considered possible approaches toward harmonized drug development. Representatives from the US Food and Drug Administration, European Medicines Agency, Health Canada, and the Pharmaceuticals and Medical Devices Agency of Japan convened monthly to explore existing regulatory approaches, reviewed the results of a literature search, and provided perspectives on pediatric UC drug development based on the available medical literature. Although pediatric UC, when compared with UC in adults, has a similar disease progression and response to intervention, the similarity of the exposure-response relation has not been adequately established. Consequently, clinical endpoints should be selected to optimally assess efficacy in children. The inclusion of a placebo control in pediatric trials to assure assay sensitivity may be appropriate under limited circumstances. In clinical studies, although the drug under investigation could provide possible direct benefit, placebo treatment should present no more than a minor increase over minimal risk to children with UC. Partial extrapolation of efficacy from informative adult studies may be appropriate. Placebo-controlled efficacy trials are scientifically and ethically appropriate for pediatric UC given appropriate patient selection and the use of early escape. Clinical studies in pediatric UC may include initial dose-finding studies and exposure-response modeling followed by an efficacy and safety study to further explore the exposure-response relation.

  9. 73. VIEW OF LAUNCH OPERATOR AND LAUNCH ANAYLST PANELS LOCATED ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    73. VIEW OF LAUNCH OPERATOR AND LAUNCH ANAYLST PANELS LOCATED NEAR CENTER OF SOUTH WALL OF SLC-3E CONTROL ROOM. FROM LEFT TO RIGHT ON WALL IN BACKGROUND: COMMUNICATIONS HEADSET AND FOOT PEDAL IN FORGROUND. ACCIDENT REPORTING EMERGENCY NOTIFICATION SYSTEM TELEPHONE, ATLAS H FUEL COUNTER, AND DIGITAL COUNTDOWN CLOCK. - Vandenberg Air Force Base, Space Launch Complex 3, Launch Operations Building, Napa & Alden Roads, Lompoc, Santa Barbara County, CA

  10. Can Chinese Herbal Medicine Improve Outcomes of In Vitro Fertilization? A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Cao, Huijuan; Han, Mei; Ng, Ernest H. Y.; Wu, Xiaoke; Flower, Andrew; Lewith, George; Liu, Jian-Ping

    2013-01-01

    Background A large number of infertile couples are choosing Chinese herbal medicine (CHM) as an adjuvant therapy to improve their success when undergoing in vitro fertilization (IVF). There is no systematic review to evaluate the impact of CHM on the IVF outcomes. Objective To evaluate the effectiveness of CHM with concurrent IVF versus IVF alone on the outcomes of IVF and its safety. Methods The protocol of this study is registered at PROSPERO. Eligible RCTs searched from 8 databases which compared a combination of CHM and IVF with IVF alone were included. Two authors independently selected studies, extracted data and assessed methodological quality. Meta-analysis of RCTs was conducted if there was non-significant heterogeneity (evaluated by I2 test) among trials. All statistical analysis was performed using RevMan 5.1 software. Results Twenty trials involving 1721 women were included in the meta-analysis. Three trials were evaluated as having an unclear risk of bias. The remaining trials were evaluated as having a high risk of bias. Combination of CHM and IVF significantly increases clinical pregnancy rates (OR 2.04, 95%CI 1.67 to 2.49, p<0.00001) and ongoing pregnancy rates (OR 1.91, 95%CI 1.17 to 3.10, p = 0.009). Use of CHM after embryo transfer had no better outcome in reducing the rate of ovarian hyper stimulation syndrome (OR 0.39, 95%CI 0.14 to 1.11, p = 0.08). Conclusions This meta-analysis showed that combination of IVF and CHM used in the included trials improve IVF success, however due to the high risk of bias observed with the trials, the significant differences found with the meta-analysis are unlikely to be accurate. No conclusion could be drawn with respect to the reproductive toxicity of CHM. Further large randomized placebo controlled trials are warranted to confirm these findings before recommending women to take CHM to improve their IVF success. PMID:24339951

  11. [Effects of Hengyan medicinal recipe on the regulation of immunity in patients with severe sepsis: a prospective clinical trial].

    PubMed

    Zhang, Zhao-Hui; Zhou, Gang; Gong, Xun; Zhang, Rong; Qu, Xing-Guang; Zeng, Chao; Liu, Jing-Lan

    2011-02-01

    To observe the role of Hengyan medicinal recipe on the regulation of immunity in patients with severe sepsis. Patients with severe sepsis included in the study were randomly divided into two groups. Hengyan medicinal recipe group (n=22), in which patients were treated with Hengyan medicinal recipe 50 ml, 3 times daily, for 7 days.The recipe was composed of Bombyx batryticatus 10 g, Cicada slough 10 g, Curcuma 10 g, Rhubarb 3 g, Radix astragalus 10 g, Radix ophiopogonis 10 g, Red ginseng 10 g, Paeony 10 g, Walnut kernel 10 g, Safflower 10 g, combined with western medicine treatment.The patients in control group (n=23) were treated with western medicine same as above. In all patients the number of bowel movement and the scores of acute physiology and chronic health evaluationII (APACHEII) were recorded. Blood was taken for the determination of the levels of interleukins (IL-6, IL-10), tumor necrosis factor-α (TNF-α), CD3(+), CD4(+), CD8(+) T cell before and 1, 3, 7 days after the treatment. Compared with the control group, the number of bowel movement, scores of APACHEII and IL-6, IL-10, IL-6/IL-10, TNF-α in Hengyan medicinal recipe group were decreased significantly at 7 days, while the levels of CD3(+), CD4(+), CD8(+) T cell were increased significantly [the number of bowel movement (times): 2.1±0.7 vs. 0.6±0.6, APACHEII score: 13.8±5.6 vs. 16.8±5.6, IL-6 (ng/L): 45 (32, 89) vs. 80 (41, 116), IL-10 (ng/L): 4.2 (3.6, 9.8) vs. 6.6 (3.5, 10.6), IL-6/IL-10:10.6 (7.2, 24.8) vs. 12.8 (7.6, 28.8), TNF-α (ng/L):4.2±2.6 vs. 5.6±2.7, CD3(+): 6.59±2.80 vs. 5.65±2.92, CD4(+): 3.65±2.17 vs. 3.25±2.46, CD8(+): 2.73±1.29 vs. 2.26±1.48, P<0.05 or P<0.01]. Hengyan medicinal recipe could not only reduce the systemic inflammation, but also plays a role in bidirectional regulation of the immune disturbance to ameliorate immune suppression of sepsis patients.

  12. 25. Corridor between the Launch Control Center and the Launch ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    25. Corridor between the Launch Control Center and the Launch Control Equipment Room, view from Launch Control Center. Thalheimer - Whiteman Air Force Base, Oscar O-1 Minuteman Missile Alert Facility, Southeast corner of Twelfth & Vendenberg Avenues, Knob Noster, Johnson County, MO

  13. Launch Services Program EMC Issues

    NASA Technical Reports Server (NTRS)

    trout, Dawn

    2004-01-01

    Presentation covers these issues: (1) Vehicles of the Launch Services Program, (2) RF Environment, (3) Common EMC Launch Vehicle Payload Integration Issues, (4) RF Sensitive Missions and (5) Lightning Monitoring,

  14. Launch Vehicle Control Center Architectures

    NASA Technical Reports Server (NTRS)

    Watson, Michael D.; Epps, Amy; Woodruff, Van; Vachon, Michael Jacob; Monreal, Julio; Williams, Randall; McLaughlin, Tom

    2014-01-01

    This analysis is a survey of control center architectures of the NASA Space Launch System (SLS), United Launch Alliance (ULA) Atlas V and Delta IV, and the European Space Agency (ESA) Ariane 5. Each of these control center architectures have similarities in basic structure, and differences in functional distribution of responsibilities for the phases of operations: (a) Launch vehicles in the international community vary greatly in configuration and process; (b) Each launch site has a unique processing flow based on the specific configurations; (c) Launch and flight operations are managed through a set of control centers associated with each launch site, however the flight operations may be a different control center than the launch center; and (d) The engineering support centers are primarily located at the design center with a small engineering support team at the launch site.

  15. Launching Garbage-Bag Balloons.

    ERIC Educational Resources Information Center

    Kim, Hy

    1997-01-01

    Presents a modification of a procedure for making and launching hot air balloons made out of garbage bags. Student instructions for balloon construction, launching instructions, and scale diagrams are included. (DDR)

  16. SMAP Launch and Deployment Sequence

    NASA Image and Video Library

    This video combines file footage of a Delta II rocket and computer animation to depict the launch and deployment of NASA's Soil Moisture Active Passive satellite. SMAP is scheduled to launch on Nov...

  17. Non-superiority of Kakkonto, a Japanese herbal medicine, to a representative multiple cold medicine with respect to anti-aggravation effects on the common cold: a randomized controlled trial.

    PubMed

    Okabayashi, Satoe; Goto, Masashi; Kawamura, Takashi; Watanabe, Hidetsuna; Kimura, Akira; Uruma, Reiko; Takahashi, Yuko; Taneichi, Setsuko; Musashi, Manabu; Miyaki, Koichi

    2014-01-01

    Kakkonto, a Japanese herbal medicine, is frequently used to treat the common cold not only with a physician's prescription, but also in self-medication situations. This study aimed to examine whether Kakkonto prevents the aggravation of cold symptoms if taken at an early stage of illness compared with a well-selected Western-style multiple cold medicine. This study was a multicenter, active drug-controlled, randomized trial. Adults 18 to 65 years of age who felt a touch of cold symptoms and visited 15 outpatient healthcare facilities within 48 hours of symptoms onset were enrolled. The participants were randomly assigned to two groups: one treated with Kakkonto (Kakkonto Extract-A, 6 g/day) (n=209) and one treated with a Western-style multiple cold medicine (Pabron Gold-A, 3.6 g/day) (n=198) for at most four days. The primary outcome of this study was the aggravation of cold, nasal, throat or bronchial symptoms, scored as moderate or severe and lasting for at least two days within five days after entry into the study. Among the 410 enrollees, 340 (168 in the Kakkonto group and 172 in the Pabron group) were included in the analyses. The proportion of participants whose colds were aggravated was 22.6% in the Kakkonto group and 25.0% in the Pabron group (p=0.66). The overall severity of the cold symptoms was not significantly different between the groups. No harmful adverse events occurred in either group. Kakkonto did not significantly prevent the progression of cold symptoms, even when prescribed at an early stage of the disease.

  18. Intelsat satellite scheduled for launch

    NASA Technical Reports Server (NTRS)

    1981-01-01

    The launch schedule for Intelsat 5-B, the prime Intelsat satellite to provide communications services between the Americas, Europe, the Middle East, and Africa, is presented. The planned placement of the satellite into an elliptical transfer orbit, and circularization of the orbit at geosynchronous altitude over the equator are described. Characteristics of the Atlas Centaur launch vehicle, AC-56, are given. The launch operation is summarized and the launch sequence presented. The Intelsat team and contractors are listed.

  19. Official launching of FRIPON

    NASA Astrophysics Data System (ADS)

    Colas, François

    2016-02-01

    Tuesday May 31st, 2016 marks the official launch of FRIPON, a unique interconnected network to search for meteorites. Eventually comprising 100 cameras spread out all over France, FRIPON introduces a night and day 360° watch of the sky. Born from the joint scientific expertise of Observatoire de Paris, of Muséum national d’Histoire naturelle, of Université Paris-Sud, of Université Aix-Marseille and of CNRS, this network aims to detect meteorite falls, measure their trajectories and estimate their strewnfields so that field search campaigns can be organized.

  20. Launch team training system

    NASA Technical Reports Server (NTRS)

    Webb, J. T.

    1988-01-01

    A new approach to the training, certification, recertification, and proficiency maintenance of the Shuttle launch team is proposed. Previous training approaches are first reviewed. Short term program goals include expanding current training methods, improving the existing simulation capability, and scheduling training exercises with the same priority as hardware tests. Long-term goals include developing user requirements which would take advantage of state-of-the-art tools and techniques. Training requirements for the different groups of people to be trained are identified, and future goals are outlined.

  1. Expedition 18 Launch Day

    NASA Image and Video Library

    2008-10-11

    Expedition 18 Commander Michael Fincke waves goodbye to family and friends from the bus that will take him and fellow crew members Flight Engineer Yuri V. Lonchakov and American spaceflight participant Richard Garriott to the Soyuz TMA-13 spacecraft for launch, Sunday, Oct. 12, 2008 from the Baikonur Cosmodrome in Kazakhstan. The three crew members are scheduled to dock with the International Space Station on Oct. 14. Fincke and Lonchakov will spend six months on the station, while Garriott will return to Earth Oct. 24 with two of the Expedition 17 crew members currently on the International Space Station. Photo Credit: (NASA/Victor Zelentsov)

  2. Expedition 18 Launch Day

    NASA Image and Video Library

    2008-10-11

    Expedition 18 Flight Engineer Yuri V. Lonchakov walks from the crew bus to the Soyuz rocket with Expedition 18 Commander Michael Fincke, not pictured, and American spaceflight participant Richard Garriott, background left, prior to their launch in the Soyuz TMA-13 spacecraft, Sunday, Oct. 12, 2008 from the Baikonur Cosmodrome in Kazakhstan. The three crew members are scheduled to dock with the International Space Station on Oct. 14. Fincke and Lonchakov will spend six months on the station, while Garriott will return to Earth Oct. 24 with two of the Expedition 17 crew members currently on the International Space Station. Photo Credit: (NASA/Bill Ingalls)

  3. Expedition 18 Launch Day

    NASA Image and Video Library

    2008-10-11

    Expedition 18 Commander Michael Fincke waves farewell from the crew bus as he and Flight Engineer Yuri V. Lonchakov and American spaceflight participant Richard Garriott depart the Cosmonaut Hotel to building 254 were they will don their flight suits prior to their launch, Sunday, Oct. 12, 2008, from the Baikonur Cosmodrome in Kazakhstan. The three crew members are scheduled to dock with the International Space Station on Oct. 14. Fincke and Lonchakov will spend six months on the station, while Garriott will return to Earth Oct. 24 with two of the Expedition 17 crew members currently on the International Space Station. Photo Credit: (NASA/Bill Ingalls)

  4. Expedition 18 Launch Day

    NASA Image and Video Library

    2008-10-11

    American spaceflight participant Richard Garriott, left, Expedition 18 Flight Engineer Yuri V. Lonchakov and Expedition 18 Commander Michael Fincke, right, depart building 254 where the crew donned their spacesuits prior to launch in the Soyuz TMA-13 spacecraft, Sunday Oct. 12, 2008 from the Baikonur Cosmodrome in Kazakhstan. The crew is scheduled to dock to the International Space Station on Oct. 14. Fincke and Lonchakov will spend six months on the station, while Garriott will return to Earth Oct. 24 with two of the Expedition 17 crewmembers currently on the International Space Station. Photo Credit: (NASA/Victor Zelentsov)

  5. Expedition 18 Launch Day

    NASA Image and Video Library

    2008-10-11

    Expedition 18 Flight Engineer Yuri V. Lonchakov, bottom, Expedition 18 Commander Michael Fincke and American spaceflight participant Richard Garriott, top, board the Soyuz rocket prior to their launch in the Soyuz TMA-13 spacecraft, Sunday, Oct. 12, 2008 from the Baikonur Cosmodrome in Kazakhstan. The three crew members are scheduled to dock with the International Space Station on Oct. 14. Fincke and Lonchakov will spend six months on the station, while Garriott will return to Earth Oct. 24 with two of the Expedition 17 crew members currently on the International Space Station. Photo Credit: (NASA/Bill Ingalls)

  6. Expedition 18 Launch Day

    NASA Image and Video Library

    2008-10-11

    American spaceflight participant Richard Garriott, left, Expedition 18 Flight Engineer Yuri V. Lonchakov and Expedition 18 Commander Michael Fincke, right, prepare to salute officials prior to launch in the Soyuz TMA-13 spacecraft, Sunday Oct. 12, 2008 from the Baikonur Cosmodrome in Kazakhstan. The crew is scheduled to dock to the International Space Station on Oct. 14. Fincke and Lonchakov will spend six months on the station, while Garriott will return to Earth Oct. 24 with two of the Expedition 17 crewmembers currently on the International Space Station. Photo Credit: (NASA/Victor Zelentsov)

  7. STS-127 Launch HD

    NASA Image and Video Library

    2009-11-16

    Space shuttle Atlantis and its six-member crew began an 11-day delivery flight to the International Space Station on Monday with a 2:28 p.m. EST launch from NASA's Kennedy Space Center in Florida. The shuttle will transport spare hardware to the outpost and return a station crew member who spent more than two months in space. Atlantis is carrying about 30,000 pounds of replacement parts for systems that provide power to the station, keep it from overheating, and maintain a proper orientation in space. The large equipment can best be transported using the shuttle's unique capabilities

  8. STS-69 launch views

    NASA Image and Video Library

    1996-09-07

    STS069-S-023 (7 September 1995) --- Liftoff of the Space Shuttle Endeavour from Launch Pad 39A occurred at 11:09:00:52 a.m. (EDT), September 7, 1995. The crew of five NASA astronauts was embarking on an 11-day multifaceted mission featuring two free-flying scientific research spacecraft, a spacewalk and a host of experiments in both the cargo bay and the middeck. Onboard were astronauts David M. Walker, Kenneth D. Cockrell, James S. Voss, James H. Newman and Michael L. Gernhardt.

  9. STS-69 launch views

    NASA Image and Video Library

    1996-09-07

    STS069-S-024 (7 September 1995) --- Trees and shrubs frame the liftoff phase of the Space Shuttle Endeavour as it begins the STS-69 mission. Liftoff from Launch Pad 39A occurred at 11:09:00:52 a.m. (EDT), September 7, 1995. The crew of five NASA astronauts is embarking on an 11-day multifaceted mission featuring two free-flying scientific research spacecraft, a spacewalk and a host of experiments in both the cargo bay and the middeck. Onboard were astronauts David M. Walker, Kenneth D. Cockrell, James S. Voss, James H. Newman and Michael L. Gernhardt.

  10. STS-69 launch views

    NASA Image and Video Library

    1996-09-07

    STS069-S-019 (7 September 1995) --- Florida shrubbery frames the liftoff phase of the Space Shuttle Endeavour as it begins the STS-69 mission. Liftoff from Launch Pad 39A occurred at 11:09:00:52 a.m. (EDT), September 7, 1995. The crew of five NASA astronauts is embarking on an 11-day multifaceted mission featuring two free-flying scientific research spacecraft, a spacewalk and a host of experiments in both the cargo bay and the middeck. Onboard were astronauts David M. Walker, Kenneth D. Cockrell, James S. Voss, James H. Newman and Michael L. Gernhardt.

  11. STS-69 launch views

    NASA Image and Video Library

    1996-09-07

    STS069-S-022 (7 September 1995) --- Marsh driftwood and Florida shrubbery frame the liftoff phase of the Space Shuttle Endeavour as it begins the STS-69 mission. Liftoff from Launch Pad 39A occurred at 11:09:00:52 a.m. (EDT), September 7, 1995. The crew of five NASA astronauts is embarking on an 11-day multifaceted mission featuring two free-flying scientific research spacecraft, a spacewalk and a host of experiments in both the cargo bay and the middeck. Onboard were astronauts David M. Walker, Kenneth D. Cockrell, James S. Voss, James H. Newman and Michael L. Gernhardt.

  12. Expedition 12 Launch

    NASA Image and Video Library

    2005-10-01

    JSC2005-E-40271 (1 Oct. 2005) --- A Soyuz rocket launches from the Baikonur Cosmodrome, Kazakhstan with astronaut William S. (Bill) McArthur, Jr., Expedition 12 commander; cosmonaut Valery I. Tokarev, flight engineer and Soyuz commander; and U.S. spaceflight participant Gregory Olsen aboard. The trio is on a mission to the International Space Station lasting six months for McArthur and Tokarev. Olsen will return with the current station crew, Expedition 11, after ten days in space under a commercial contract with the Russian Federal Space Agency. Photo Credit: NASA/Victor Zelentsov

  13. Expedition 22 Launch Day

    NASA Image and Video Library

    2009-12-20

    Expedition 22 NASA Flight Engineer Timothy J. Creamer of the U.S., left, and Flight Engineer Soichi Noguchi of Japan pose for a photograph with NASA Flight Surgeon Pete Bauer, standing left, and NASA Expedition 22 backup Astronaut Doug Wheelock at the Baikonur Cosmodrome in Baikonur, Kazakhstan, Sunday, Dec. 20, 2009. Creamer, Noguchi and fellow Expedition 22 crew member, Soyuz Commander Oleg Kotov of Russia, launched in their Soyuz TMA-17 rocket from the Baikonur Cosmodrome in Kazakhstan on Monday, Dec. 21, 2009. (Photo Credit: NASA/Bill Ingalls)

  14. LAUNCH - STS-8 - KSC

    NASA Image and Video Library

    1983-09-01

    S83-39513 (30 Aug. 1983) --- NASA's eighth space shuttle launch lights up the Florida sky at 2:32 a.m. (EDT), Aug. 30, 1983. The Challenger's third flight is the first to have its beginnings in darkness. Five astronauts and an assortment of experiments are aboard the reusable vehicle. Crew members are astronauts Richard H. Truly, STS-8 commander; Daniel C. Brandenstein, pilot; and Dale A. Gardner, Guion S. Bluford and William E. Thornton, all mission specialists. Photo credit: NASA

  15. LAUNCH - STS-8 - KSC

    NASA Image and Video Library

    1983-09-01

    S83-39512 (30 Aug. 1983) --- NASA's eighth space shuttle launch lights up the Florida sky at 2:32 a.m. (EDT), Aug. 30, 1983. The space shuttle Challenger's third flight is the first to have its beginnings in darkness. Five astronauts and an assortment of experiments are aboard the reusable vehicle. Crew members are astronauts Richard H. Truly, STS-8 commander; Daniel C. Brandenstein, pilot; and Dale A. Gardner, Guion S. Bluford and William E. Thornton, all mission specialists. Photo credit: NASA

  16. Apollo 13 Launch

    NASA Technical Reports Server (NTRS)

    1970-01-01

    The third marned lunar landing mission, Apollo 13 (SA-508), with three astronauts: Mission commander James A. Lovell Jr., Lunar Module pilot Fred W. Haise Jr., and Command Module pilot John L. Swigert Jr., lifted off from the Kennedy Space Center launch complex 39A on April 11, 1970. The mission was aborted after 56 hours of flight, 205,000 miles from Earth, when an oxygen tank in the service module exploded. The Command Module, Odyssey, carrying the three astronauts, safely splashed down in the Pacific Ocean at 1:08 p.m. EST, April 17, 1970.

  17. STS-115 Launch

    NASA Technical Reports Server (NTRS)

    2005-01-01

    The Space Shuttle Atlantis and its six-member crew launched at 11:15 a.m. (EDT) on September 9, 2006 to begin the two-day journey to the International Space Station (ISS) on the STS-115 mission. During the 11-day mission, the STS-115 crew of six, along with station crews and ground teams, resumed construction of the ISS with the installation of a girder-like structure, known as the P3/P4 truss. The 35,000-pound piece includes a set of giant solar arrays, batteries and associated electronics. The arrays eventually will double the power capability of the Station.

  18. STS-39 Launch

    NASA Technical Reports Server (NTRS)

    1991-01-01

    Launched aboard the Space Shuttle Discovery on April 28, 1991 at 7:33:14 am (EDT), STS-39 was a Department of Defense (DOD) mission. The crew included seven astronauts: Michael L. Coats, commander; L. Blaine Hammond, pilot; Guion S. Buford, Jr., mission specialist 1; Gregory J. Harbaugh, mission specialist 2; Richard J. Hieb, mission specialist 3; Donald R. McMonagle, mission specialist 4; and Charles L. Veach, mission specialist 5. The primary unclassified payload included the Air Force Program 675 (AFP-675), the Infrared Background Signature Survey (IBSS), and the Shuttle Pallet Satellite II (SPAS II).

  19. Launch summary for 1978 - 1982

    NASA Astrophysics Data System (ADS)

    Hills, H. K.

    1984-01-01

    Data pertinent to the launching of space probes, soundings rockets, and satellites presented in tables include launch date, time, and site; agency rocket identification; sponsoring country or countries; instruments carried for experiments; the peak altitude achieved by the rockets; and the apoapsis and periapsis for satellites. The experimenter or institution involved in the launching is also cited.

  20. Launch Vehicle Control Center Architectures

    NASA Technical Reports Server (NTRS)

    Watson, Michael D.; Epps, Amy; Woodruff, Van; Vachon, Michael Jacob; Monreal, Julio; Levesque, Marl; Williams, Randall; Mclaughlin, Tom

    2014-01-01

    Launch vehicles within the international community vary greatly in their configuration and processing. Each launch site has a unique processing flow based on the specific launch vehicle configuration. Launch and flight operations are managed through a set of control centers associated with each launch site. Each launch site has a control center for launch operations; however flight operations support varies from being co-located with the launch site to being shared with the space vehicle control center. There is also a nuance of some having an engineering support center which may be co-located with either the launch or flight control center, or in a separate geographical location altogether. A survey of control center architectures is presented for various launch vehicles including the NASA Space Launch System (SLS), United Launch Alliance (ULA) Atlas V and Delta IV, and the European Space Agency (ESA) Ariane 5. Each of these control center architectures shares some similarities in basic structure while differences in functional distribution also exist. The driving functions which lead to these factors are considered and a model of control center architectures is proposed which supports these commonalities and variations.