CIRM Alpha Stem Cell Clinics: Collaboratively Addressing Regenerative Medicine Challenges.

PubMed

Jamieson, Catriona H M; Millan, Maria T; Creasey, Abla A; Lomax, Geoff; Donohoe, Mary E; Walters, Mark C; Abedi, Mehrdad; Bota, Daniela A; Zaia, John A; Adams, John S

2018-06-01

The California Institute for Regenerative Medicine (CIRM) Alpha Stem Cell Clinic (ASCC) Network was launched in 2015 to address a compelling unmet medical need for rigorous, FDA-regulated, stem cell-related clinical trials for patients with challenging, incurable diseases. Here, we describe our multi-center experiences addressing current and future challenges. Copyright © 2018 Elsevier Inc. All rights reserved.

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

Herbal medicines for treating acute otitis media: A systematic review of randomised controlled trials.

PubMed

Son, Mi Ju; Kim, Young-Eun; Song, Young Il; Kim, Yun Hee

2017-12-01

This systematic review aimed to assess the clinical evidence for the widespread use of herbal medicines in treating acute otitis media. Eleven electronic databases, including MEDLINE, EMBASE, and the CENTRAL were searched, without language limitations. All randomised controlled trials involving the use of herbal medicines, alone or in combination with conventional therapies, for acute otitis media were included. We identified 4956 studies, of which seven randomised clinical trials met the inclusion criteria. The overall risk of bias of the included trials was relatively high or unclear. Treatment with Longdan-xiegan decoction or Shenling-baizhu powder, combined with antibiotics, appeared to be more effective than treatment with antibiotics alone in terms of the proportion of patients with total symptom recovery. Moreover, combination treatment of Sinupret ® and antibiotics facilitated the recovery of middle ear conditions and hearing acuity. Despite some indications of potential symptom improvement, the evidence regarding the effectiveness and efficacy of herbal medicine for acute otitis media is inconclusive due to the poor quality of trials included. Moreover, we only analysed seven trials in this review. Therefore, to properly evaluate the effectiveness of herbal medicine for acute otitis media, systematic reviews based on more rigorously designed randomized trials are warranted in the future. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

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

Randomised trials in context: practical problems and social aspects of evidence-based medicine and policy.

PubMed

Pearce, Warren; Raman, Sujatha; Turner, Andrew

2015-09-01

Randomised trials can provide excellent evidence of treatment benefit in medicine. Over the last 50 years, they have been cemented in the regulatory requirements for the approval of new treatments. Randomised trials make up a large and seemingly high-quality proportion of the medical evidence-base. However, it has also been acknowledged that a distorted evidence-base places a severe limitation on the practice of evidence-based medicine (EBM). We describe four important ways in which the evidence from randomised trials is limited or partial: the problem of applying results, the problem of bias in the conduct of randomised trials, the problem of conducting the wrong trials and the problem of conducting the right trials the wrong way. These problems are not intrinsic to the method of randomised trials or the EBM philosophy of evidence; nevertheless, they are genuine problems that undermine the evidence that randomised trials provide for decision-making and therefore undermine EBM in practice. Finally, we discuss the social dimensions of these problems and how they highlight the indispensable role of judgement when generating and using evidence for medicine. This is the paradox of randomised trial evidence: the trials open up expert judgment to scrutiny, but this scrutiny in turn requires further expertise.

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.

Clinical trial transparency update: an assessment of the disclosure of results of company-sponsored trials associated with new medicines approved in Europe in 2014.

PubMed

Deane, Bryan R; Porkess, Sheuli

2018-07-01

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 2014. This is the final extension of three previously reported studies of trials related to all new medicines approved in Europe in 2009, 2010 and 2011, and in 2012 and 2013. 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 (31 January 2013). The extension studies (2012 and 2013 approvals) both showed an improvement in results disclosure within 12 months to 90%, and an overall disclosure rate of 92% and 93% respectively by the end of the studies. 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 2014, 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 2016. 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 2016 (end of survey). Of the completed trials associated with 32 new medicines licensed to 22 different companies in 2014, results of 93% (505/542) had been disclosed within 12 months, and results of 96% (518/542) had been disclosed by 31 July 2016. The disclosure rate within 12 months of 93% suggests that industry is continuing to achieve disclosure in a timely manner. The overall disclosure rate at study end of 96% indicates that the improvement in transparency

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.

Systems pharmacology, pharmacogenetics, and clinical trial design in network medicine.

PubMed

Antman, Elliott; Weiss, Scott; Loscalzo, Joseph

2012-01-01

The rapidly growing disciplines of systems biology and network science are now poised to meet the fields of clinical medicine and pharmacology. Principles of systems pharmacology can be applied to drug design and, ultimately, testing in human clinical trials. Rather than focusing exclusively on single drug targets, systems pharmacology examines the holistic response of a phenotype-dependent pathway or pathways to drug perturbation. Knowledge of individual pharmacogenetic profiles further modulates the responses to these drug perturbations, moving the field toward more individualized ('personalized') drug development. The speed with which the information required to assess these system responses and their genomic underpinnings is changing and the importance of identifying the optimal drug or drug combinations for maximal benefit and minimal risk require that clinical trial design strategies be adaptable. In this paper, we review the tenets of adaptive clinical trial design as they may apply to an era of expanding knowledge of systems pharmacology and pharmacogenomics, and clinical trail design in network medicine. Copyright © 2012 Wiley Periodicals, Inc.

[Methodological quality evaluation of randomized controlled trials for traditional Chinese medicines for treatment of sub-health].

PubMed

Zhao, Jun; Liao, Xing; Zhao, Hui; Li, Zhi-Geng; Wang, Nan-Yue; Wang, Li-Min

2016-11-01

To evaluate the methodological quality of the randomized controlled trials(RCTs) for traditional Chinese medicines for treatment of sub-health, in order to provide a scientific basis for the improvement of clinical trials and systematic review. Such databases as CNKI, CBM, VIP, Wanfang, EMbase, Medline, Clinical Trials, Web of Science and Cochrane Library were searched for RCTS for traditional Chinese medicines for treatment of sub-health between the time of establishment and February 29, 2016. Cochrane Handbook 5.1 was used to screen literatures and extract data, and CONSORT statement and CONSORT for traditional Chinese medicine statement were adopted as the basis for quality evaluation. Among the 72 RCTs included in this study, 67 (93.05%) trials described the inter-group baseline data comparability, 39(54.17%) trials described the unified diagnostic criteria, 28(38.89%) trials described the unified standards of efficacy, 4 (5.55%) trials mentioned the multi-center study, 19(26.38%) trials disclosed the random distribution method, 6(8.33%) trials used the random distribution concealment, 15(20.83%) trials adopted the method of blindness, 3(4.17%) study reported the sample size estimation in details, 5 (6.94%) trials showed a sample size of more than two hundred, 19(26.38%) trials reported the number of withdrawal, defluxion cases and those lost to follow-up, but only 2 trials adopted the ITT analysis,10(13.89%) trials reported the follow-up results, none of the trial reported the test registration and the test protocol, 48(66.7%) trials reported all of the indicators of expected outcomes, 26(36.11%) trials reported the adverse reactions and adverse events, and 4(5.56%) trials reported patient compliance. The overall quality of these randomized controlled trials for traditional Chinese medicines for treatment of sub-health is low, with methodological defects in different degrees. Therefore, it is still necessary to emphasize the correct application of principles

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.

Chinese herbal medicine for the treatment of recurrent miscarriage: a systematic review of randomized clinical trials

PubMed Central

2013-01-01

Background Traditional Chinese medicine has been widely used for the treatment of recurrent miscarriage in China and other Asian countries for long time. We conducted this review to systematically summarize the evidences of Chinese herbal medicine (CHM) for the prevention and treatment of recurrent miscarriage in randomized trials, and evaluate the effectiveness and safety of CHM compared with placebo or conventional medicine. Methods We searched studies in PubMed, ClinicalTrials, the Cochrane Library, CNKI, SinoMed and VIP databases until December, 2012. Randomized trials on CHM alone or in combination with conventional medicine for recurrent miscarriage compared with placebo or conventional medicine were included. We evaluated the methodological quality of each included trials using the Cochrane risk of bias tool. Results A total of 41 RCTs (3660 participants) were included. The majority of trials had a high or unclear risk of bias. CHM used alone or plus progesterone-based treatment showed superior effect over progesterone-based treatment in improving live birth rate and embryonic developmental state (measured by B ultrasound). However, there is substantial heterogeneity within each subgroup analysis (I2 ranging from 35% to 71%). CHM plus progesterone and hCG-based treatment was superior to progesterone and hCG-based treatment in improving the embryonic developmental state, but not live birth rate. No severe adverse events were reported in relation to CHM. Conclusions Some Chinese herbal medicines or in combination with progesterone-based treatment demonstrated potentially beneficial effect in improving live birth rate and embryonic developmental state for women with recurrent miscarriage. However, due to the substantial heterogeneity among the herbal interventions and limitations of methodological quality of the included trials, it is not possible to recommend any specific CHMs for recurrent miscarriage. Further rigorous clinical trials are warranted to

Cannabinergic pain medicine: a concise clinical primer and survey of randomized-controlled trial results.

PubMed

Aggarwal, Sunil K

2013-02-01

This article attempts to cover pragmatic clinical considerations involved in the use of cannabinergic medicines in pain practice, including geographical and historical considerations, pharmacokinetics, pharmacodynamics, adverse effects, drug interactions, indications, and contraindications. Topics include molecular considerations such as the 10-fold greater abundance of cannabinoid type 1 receptors compared to µ-opioid receptors in the central nervous system and anatomic distributions of cannabinoid receptors in pain circuits. The article uses a narrative review methodology drawing from authoritative textbooks and journals of cannabinoid medicine, Food and Drug Administration-approved cannabinoid drug labels, and current and historical pain medicine literature to address core clinical considerations. To survey the current evidence base for pain management with cannabinergic medicines, a targeted PubMed search was performed to survey the percentage of positive and negative published randomized-controlled trial (RCT) results with this class of pain medicines, using appropriate search limit parameters and the keyword search string "cannabinoid OR cannabis-based AND pain." Of the 56 hits generated, 38 published RCTs met the survey criteria. Of these, 71% (27) concluded that cannabinoids had empirically demonstrable and statistically significant pain-relieving effects, whereas 29% (11) did not. Cannabis and other cannabinergic medicines' efficacies for relieving pain have been studied in RCTs, most of which have demonstrated a beneficial effect for this indication, although most trials are short-term. Adverse effects are generally nonserious and well tolerated. Incorporating cannabinergic medicine topics into pain medicine education seems warranted and continuing clinical research and empiric treatment trials are appropriate.

Emergency medicine leadership in industry-sponsored clinical trials.

PubMed

Newgard, Craig D; Kim, Sunghye; Camargo, Carlos A

2003-02-01

To identify and characterize emergency medicine (EM) researchers who, since 1990, have served on a steering committee (SC) or as overall principal investigator (PI) of an industry-sponsored, multicenter clinical trial involving a pharmaceutical or device. North American EM research directors (RDs) and other prominent EM investigators (for those hospitals without a RD) were identified from eight sources, including the Society for Academic Emergency Medicine RD Interest Group and the Multicenter Airway Research Collaboration (MARC) database. The identified investigators were sent a screening survey requesting information regarding industry-sponsored clinical research at their site. The individual EM investigators identified by this screening survey were then interviewed by telephone (validation survey) to further explore their leadership experience in industry-sponsored clinical trials. Of 153 identified RDs and prominent EM researchers, 138 responded to the screening survey (90% response rate). Eighty-five EM investigators reportedly had served on a SC or as overall PI for an industry-sponsored clinical trial. Of these 85 North American EM investigators, 77 were available for a structured telephone interview (91% response rate). Although 41 (53%) of the investigators confirmed their leadership role, 36 (47%) had not served in either role. Among the 41 confirmed investigators, 19 (25%) had served as a SC member, 10 (13%) had served as overall PI, and 12 (16%) had experience in both roles. Individual responses provided suggestions for pursuing such leadership positions. These data suggest the opportunity to expand EM leadership in industry-sponsored clinical trials and demonstrate the need for validation of reports obtained by a departmental research contact. The suggestions from EM researchers who have attained these leadership roles may provide strategies for investigators interested in pursuing these positions.

Bayesian statistics in medicine: a 25 year review.

PubMed

Ashby, Deborah

2006-11-15

This review examines the state of Bayesian thinking as Statistics in Medicine was launched in 1982, reflecting particularly on its applicability and uses in medical research. It then looks at each subsequent five-year epoch, with a focus on papers appearing in Statistics in Medicine, putting these in the context of major developments in Bayesian thinking and computation with reference to important books, landmark meetings and seminal papers. It charts the growth of Bayesian statistics as it is applied to medicine and makes predictions for the future. From sparse beginnings, where Bayesian statistics was barely mentioned, Bayesian statistics has now permeated all the major areas of medical statistics, including clinical trials, epidemiology, meta-analyses and evidence synthesis, spatial modelling, longitudinal modelling, survival modelling, molecular genetics and decision-making in respect of new technologies.

Chinese Herbal Medicine for Acute Mountain Sickness: A Systematic Review of Randomized Controlled Trials

PubMed Central

Wang, Jie; Xiong, Xingjiang; Xing, Yanwei; Liu, Zhen; Jiang, Wenrui; Huang, Junyi; Feng, Bo

2013-01-01

Objectives. We aimed to assess the current clinical evidence of Chinese herbal medicine for AMS. Methods. Seven electronic databases were searched until January 2013. We included randomized clinical trials testing Chinese herbal medicine against placebo, no drugs, Western drugs, or a combination of routine treatment drugs against routine treatment drugs. Study selection, data extraction, quality assessment, and data analyses were conducted according to Cochrane standards. Results. Nine randomized trials were included. The methodological quality of the included trials was evaluated as low. Two trials compared prescriptions of Chinese formula used alone with Western drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −2.23 [−3.98, −0.49], P = 0.01). Only one trial compared prescriptions of Chinese formula used alone with no drugs. A meta-analysis showed a significant beneficial effect in decreasing the score of AMS (MD: −6.00 [−6.45, −5.55], P < 0.00001). Four trials compared Chinese formula used alone with placebo. A meta-analysis also showed a significant beneficial effect in decreasing the score of AMS (MD: −1.10 [−1.64, −0.55], P < 0.0001). Two trials compared the combination of Chinese formula plus routine treatment drugs with routine treatment drugs. A meta-analysis showed a beneficial effect in decreasing the score of AMS (MD: −5.99 [−11.11, −0.86], P = 0.02). Conclusions. No firm conclusion on the effectiveness and safety of Chinese herbal medicine for AMS can be made. More rigorous high-quality trials are required to generate a high level of evidence and to confirm the results. PMID:24454510

Drug designs fulfilling the requirements of clinical trials aiming at personalizing medicine

PubMed Central

Mandrekar, Sumithra J.; Sargent, Daniel J.

2014-01-01

In the current era of stratified medicine and biomarker-driven therapies, the focus has shifted from predictions based on the traditional anatomic staging systems to guide the choice of treatment for an individual patient to an integrated approach using the genetic makeup of the tumor and the genotype of the patient. The clinical trial designs utilized in the developmental pathway for biomarkers and biomarker-directed therapies from discovery to clinical practice are rapidly evolving. While several issues need careful consideration, two critical issues that surround the validation of biomarkers are the choice of the clinical trial design (which is based on the strength of the preliminary evidence and marker prevalence), and biomarker assay related issues surrounding the marker assessment methods such as the reliability and reproducibility of the assay. In this review, we focus on trial designs aiming at personalized medicine in the context of early phase trials for initial marker validation, as well as in the context of larger definitive trials. Designs for biomarker validation are broadly classified as retrospective (i.e., using data from previously well-conducted randomized controlled trials (RCTs) versus prospective (enrichment, all-comers, hybrid or adaptive). We believe that the systematic evaluation and implementation of these design strategies are essential to accelerate the clinical validation of biomarker guided therapy. PMID:25414851

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.

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

The role of Imaging and Radiation Oncology Core for precision medicine era of clinical trial

PubMed Central

Rosen, Mark

2017-01-01

Imaging and Radiation Oncology Core (IROC) services have been established for the quality assurance (QA) of imaging and radiotherapy (RT) for NCI’s Clinical Trial Network (NCTN) for any trials that contain imaging or RT. The randomized clinical trial is the gold standard for evidence-based medicine. QA ensures data quality, preventing noise from inferior treatments obscuring clinical trial outcome. QA is also found to be cost-effective. IROC has made great progress in multi-institution standardization and is expected to lead QA standardization, QA science in imaging and RT and to advance quality data analysis with big data in the future. The QA in the era of precision medicine is of paramount importance, when individualized decision making may depend on the quality and accuracy of RT and imaging. PMID:29218265

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

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.

Partnering With Patients in the Development and Lifecycle of Medicines

PubMed Central

Anderson, James; Boutin, Marc; Dewulf, Lode; Geissler, Jan; Johnston, Graeme; Joos, Angelika; Metcalf, Marilyn; Regnante, Jeanne; Sargeant, Ifeanyi; Schneider, Roslyn F.; Todaro, Veronica; Tougas, Gervais

2015-01-01

The purpose of medicines is to improve patients' lives. Stakeholders involved in the development and lifecycle management of medicines agree that more effective patient involvement is needed to ensure that patient needs and priorities are identified and met. Despite the increasing number and scope of patient involvement initiatives, there is no accepted master framework for systematic patient involvement in industry-led medicines research and development, regulatory review, or market access decisions. Patient engagement is very productive in some indications, but inconsistent and fragmentary on a broader level. This often results in inefficient drug development, increasing evidence requirements, lack of patient-centered outcomes that address unmet medical needs and facilitate adherence, and consequently, lack of required therapeutic options and high costs to society and involved parties. Improved patient involvement can drive the development of innovative medicines that deliver more relevant and impactful patient outcomes and make medicine development faster, more efficient, and more productive. It can lead to better prioritization of early research; improved resource allocation; improved trial protocol designs that better reflect patient needs; and, by addressing potential barriers to patient participation, enhanced recruitment and retention. It may also improve trial conduct and lead to more focused, economically viable clinical trials. At launch and beyond, systematic patient involvement can also improve the ongoing benefit-risk assessment, ensure that public funds prioritize medicines of value to patients, and further the development of the medicine. Progress toward a universal framework for patient involvement requires a joint, precompetitive, and international approach by all stakeholders, working in true partnership to consolidate outputs from existing initiatives, identify gaps, and develop a comprehensive framework. It is essential that all stakeholders

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

Herbal medicine for idiopathic central precocious puberty: A protocol for a systematic review of controlled trials.

PubMed

Lee, Hye Lim; Lee, Yoo Been; Choi, Jun-Yong; Lee, Ju Ah

2018-03-01

Herbal medicine is widely used in East Asia to treat idiopathic central precocious puberty (ICPP). Most of the available clinical trials that investigated herbal medicine for ICPP have been included in this review. This systematic review will assess the efficacy and safety of herbal medicine for ICPP. Eleven databases, including Asian databases, will be searched for studies conducted through 2018. We will include randomized controlled trials assessing herbal medicine for ICPP. The risk of bias will be evaluated using the Cochrane risk of bias assessment tool, and confidence in the cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development, and Evaluation instrument. This systematic review will be published in a peer-reviewed journal and disseminated both electronically and in print. The review will be updated to inform and guide health care practices. PROSPER 2018 CRD42018087988.

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.

Commentary: considerations for using the 'Trials within Cohorts' design in a clinical trial of an investigational medicinal product.

PubMed

Bibby, Anna C; Torgerson, David J; Leach, Samantha; Lewis-White, Helen; Maskell, Nick A

2018-01-08

The 'trials within cohorts' (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule. We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future.

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

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

Why Current Statistics of Complementary Alternative Medicine Clinical Trials is Invalid.

PubMed

Pandolfi, Maurizio; Carreras, Giulia

2018-06-07

It is not sufficiently known that frequentist statistics cannot provide direct information on the probability that the research hypothesis tested is correct. The error resulting from this misunderstanding is compounded when the hypotheses under scrutiny have precarious scientific bases, which, generally, those of complementary alternative medicine (CAM) are. In such cases, it is mandatory to use inferential statistics, considering the prior probability that the hypothesis tested is true, such as the Bayesian statistics. The authors show that, under such circumstances, no real statistical significance can be achieved in CAM clinical trials. In this respect, CAM trials involving human material are also hardly defensible from an ethical viewpoint.

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.

Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial

PubMed Central

2013-01-01

Background Functional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed. Methods/Design This is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects. Discussion This study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other

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

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.

Randomized controlled trials of simulation-based interventions in Emergency Medicine: a methodological review.

PubMed

Chauvin, Anthony; Truchot, Jennifer; Bafeta, Aida; Pateron, Dominique; Plaisance, Patrick; Yordanov, Youri

2018-04-01

The number of trials assessing Simulation-Based Medical Education (SBME) interventions has rapidly expanded. Many studies show that potential flaws in design, conduct and reporting of randomized controlled trials (RCTs) can bias their results. We conducted a methodological review of RCTs assessing a SBME in Emergency Medicine (EM) and examined their methodological characteristics. We searched MEDLINE via PubMed for RCT that assessed a simulation intervention in EM, published in 6 general and internal medicine and in the top 10 EM journals. The Cochrane Collaboration risk of Bias tool was used to assess risk of bias, intervention reporting was evaluated based on the "template for intervention description and replication" checklist, and methodological quality was evaluated by the Medical Education Research Study Quality Instrument. Reports selection and data extraction was done by 2 independents researchers. From 1394 RCTs screened, 68 trials assessed a SBME intervention. They represent one quarter of our sample. Cardiopulmonary resuscitation (CPR) is the most frequent topic (81%). Random sequence generation and allocation concealment were performed correctly in 66 and 49% of trials. Blinding of participants and assessors was performed correctly in 19 and 68%. Risk of attrition bias was low in three-quarters of the studies (n = 51). Risk of selective reporting bias was unclear in nearly all studies. The mean MERQSI score was of 13.4/18.4% of the reports provided a description allowing the intervention replication. Trials assessing simulation represent one quarter of RCTs in EM. Their quality remains unclear, and reproducing the interventions appears challenging due to reporting issues.

Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006.

PubMed

Berendt, Louise; Håkansson, Cecilia; Bach, Karin Friis; Dalhoff, Kim; Andreasen, Per Buch; Petersen, Lene Grejs; Andersen, Elin; Poulsen, Henrik Enghusen

2008-01-05

To determine the impact of the European Union's Clinical Trials Directive on the number of academic drug trials carried out in Denmark. Retrospective review of applications for drug trials to the Danish Medicines Agency, 1993-2006. Applications for drug trials for alternate years were classified as academic or commercial trials. A random subset of academic trials was reviewed for number of participants in and intended monitoring of the trials. Academic and commercial drug trials showed an identical steady decline from 1993 to 2006 and no noticeable change after 2004 when good clinical practice became mandatory for academic trials. The Clinical Trials Directive introduced in May 2004 to ensure good clinical practice for academic drug trials was not associated with a decline in research activity in Denmark; presumably because good clinical practice units had already been in place in Danish universities since 1999. With such an infrastructure academic researchers can do drug trials under the same regulations as drug companies.

[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.

[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.

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

PubMed

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

2015-01-01

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. Pragmatic cohort stepped-wedge cluster Randomised Controlled Trial (RCT) of structured nurse-led medicines' monitoring versus usual care. Five UK private sector care homes. 41 service users, taking at least one antipsychotic, antidepressant or anti-epileptic medicine. Nurses completed the West Wales ADR (WWADR) Profile for Mental Health Medicines with each participant according to trial step. Problems addressed and changes in medicines prescribed. 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. 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). 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 effects of prescribed medicines. ISRCTN 48133332.

Cannabis-based medicines--GW pharmaceuticals: high CBD, high THC, medicinal cannabis--GW pharmaceuticals, THC:CBD.

PubMed

2003-01-01

cancer, dystonias, cerebral vascular accident and spina bifida, as well as for the relief of pain and inflammation in rheumatoid arthritis and also pain relief in brachial plexus injury. The UK Government stated that it would be willing to amend the Misuse of Drugs Act 1971 to permit the introduction of a cannabis-based medicine. GW stated in its 2002 Annual Report that it was currently conducting five phase III trials of its cannabis derivatives, including a double-blind, placebo-controlled trial with a sublingual spray containing High THC in more than 100 patients with cancer pain in the UK. Also included is a phase III trial of THC:CBD (narrow ratio) being conducted in patients with severe pain due to brachial plexus injury, as are two more phase III trials of THC:CBD (narrow ratio) targeting spasticity and bladder dysfunction in multiple sclerosis patients. Another phase III trial of THC:CBD (narrow ratio) in patients with spinal cord injury is also being conducted. Results from the trials are expected during 2003. Three additional trials are also in the early stages of planning. These trials include a phase I trial of THC:CBD (broad ratio) in patients with inflammatory bowel disease, a phase I trial of High CBD in patients with psychotic disorders such as schizophrenia, and a preclinical trial of High CBD in various CNS disorders (including epilepsy, stroke and head injury). GW Pharmaceuticals submitted an application for approval of cannabis-based medicines to UK regulatory authorities in March 2003. Originally GW hoped to market cannabis-based prescription medicines by 2004, but is now planning for a launch in the UK towards the end of 2003. Several trials for GW's cannabis derivatives have also been completed, including four randomised, double-blind, placebo-controlled phase III clinical trials conducted in the UK. The trials were initiated by GW in April 2002, to investigate the use of a sublingual spray containing THC:CBD (narrow ratio) in the following medical

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

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

A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs)

PubMed Central

Jones, David R; McBlane, James W; McNaughton, Graham; Rajakumaraswamy, Nishanthan; Wydenbach, Kirsty

2013-01-01

The safety of trial subjects is the tenet that guides the regulatory assessment of a Clinical Trial Authorization application and applies equally to trials involving small molecules and those with biological/biotechnological products, including Advanced Therapy Medicinal Products. The objective of a regulator is to ensure that the potential risk faced by a trial subject is outweighed by the potential benefit to them from taking part in the trial. The focus of the application review is to assess whether risks have been identified and appropriate steps taken to alleviate these as much as possible. Other factors are also taken into account during a review, such as regulatory requirements, and emerging non-clinical and clinical data from other trials on the same or similar products. This paper examines the regulatory review process of a Clinical Trial Authorization application from the perspectives of Quality, Non-Clinical and Clinical Regulatory Assessors at the Medicines and Healthcare products Regulatory Agency. It should be noted that each perspective has highlighted specific issues from their individual competence and that these can be different between the disciplines. PMID:23216470

Concise Review: The High Cost of High Tech Medicine: Planning Ahead for Market Access

PubMed Central

Driscoll, Dawn; Farnia, Stephanie; Kefalas, Panos

2017-01-01

Abstract Cellular therapies and other regenerative medicines are emerging as potentially transformative additions to modern medicine, but likely at a staggering financial cost. Public health care systems’ budgets are already strained by growing and aging populations, and many private insurer's budgets are equally stretched. The current systems that most payers employ to manage their cash flow are not structured to absorb a sudden onslaught of very expensive prescriptions for a large portion of their covered population. Despite this, developers of new regenerative medicines tend to focus on the demands of regulators, not payers, in order to be compliant throughout the clinical trials phases, and to develop a product that ultimately will be approvable. It is not advisable to assume that an approved product will automatically become a reimbursed product, as examples from current practice in hematopoietic stem cell transplantation in the U.S. demonstrate; similarly, in Europe numerous Advanced‐therapy Medicinal Products achieved market authorization but failed to secure reimbursement (e.g., Glybera, Provenge, ChondroCelect, MACI). There are however strategies and approaches that developers can employ throughout clinical development, in order to generate clinical and health economic data which will be necessary to demonstrate the value proposition of the new product and help ensure market access for patients; furthermore, performance based managed entry agreements coupled with post‐launch evidence generation can help overcome challenges around product uncertainty at launch and reduce market access delays. Stem Cells Translational Medicine 2017;6:1723–1729 PMID:28749065

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

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.

Defining precision: The precision medicine initiative trials NCI-MPACT and NCI-MATCH.

PubMed

Coyne, Geraldine O'Sullivan; Takebe, Naoko; Chen, Alice P

"Precision" trials, using rationally incorporated biomarker targets and molecularly selective anticancer agents, have become of great interest to both patients and their physicians. In the endeavor to test the cornerstone premise of precision oncotherapy, that is, determining if modulating a specific molecular aberration in a patient's tumor with a correspondingly specific therapeutic agent improves clinical outcomes, the design of clinical trials with embedded genomic characterization platforms which guide therapy are an increasing challenge. The National Cancer Institute Precision Medicine Initiative is an unprecedented large interdisciplinary collaborative effort to conceptualize and test the feasibility of trials incorporating sequencing platforms and large-scale bioinformatics processing that are not currently uniformly available to patients. National Cancer Institute-Molecular Profiling-based Assignment of Cancer Therapy and National Cancer Institute-Molecular Analysis for Therapy Choice are 2 genomic to phenotypic trials under this National Cancer Institute initiative, where treatment is selected according to predetermined genetic alterations detected using next-generation sequencing technology across a broad range of tumor types. In this article, we discuss the objectives and trial designs that have enabled the public-private partnerships required to complete the scale of both trials, as well as interim trial updates and strategic considerations that have driven data analysis and targeted therapy assignment, with the intent of elucidating further the benefits of this treatment approach for patients. Copyright © 2017. Published by Elsevier Inc.

Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document

PubMed Central

2014-01-01

Background There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making. Methods The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document. Results Recommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design. PMID:24885146

Guidelines for randomised controlled trials investigating Chinese herbal medicine.

PubMed

Flower, Andrew; Witt, Claudia; Liu, Jian Ping; Ulrich-Merzenich, Gudrun; Yu, He; Lewith, George

2012-04-10

ETHNOGRAPHIC RELEVANCE: Clinical trials investigating Chinese herbal medicine (CHM) have been frequently criticised for their lack of scientific rigour. As part of the GP-TCM project a team of experienced clinical researchers and CHM practitioners have developed clinical trial guidelines for CHM that combine an appreciation for traditional methods of practice with detailed and practical advice on research methodology. This paper presents an executive summary of this work. It introduces the practice of CHM and the key considerations that need to be addressed whilst researching this traditional medical system. These guidelines emphasise the importance of identifying best practice, and then developing and applying appropriate and rigorous research methodologies to investigate CHM as a whole system. It is hoped that this will encourage a thoughtful and meticulous process of investigation that will clarify the contribution that CHM can make to our future healthcare. Innovative new approaches are considered including the application of the new "omic" technologies and systems biology as a way of enhancing our understanding of traditional practice. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial.

PubMed

Zhong, Linda L D; Cheng, Chung Wah; Chan, Yawen; Chan, King Hong; Lam, Ting Wa; Chen, Xiao Rui; Wong, Chi Tak; Wu, Justin C Y; Bian, Zhao Xiang

2013-11-04

Functional constipation is a common clinical complaint. Although the effectiveness of Ma Zi Ren Wan for alleviating functional constipation symptoms has been proven in a previous randomized placebo-controlled study, further evidence is needed to make clinical recommendations about Chinese herbal medicine. In particular, a comparison with conventional western medicine for functional constipation patients is needed. This is a prospective, double-blinded, double dummy, randomized, controlled trial. After a 2-week run-in period, eligible patients (Rome III) with excessive traditional Chinese medicine syndrome will randomly be assigned to the Chinese medicine arm (Ma Zi Ren Wan and western medicine placebo), western medicine arm (senna and Chinese medicine placebo) or placebo arm (Chinese medicine placebo and western medicine placebo). Patients will undergo an 8-week treatment and an 8-week follow-up. The primary outcome is the responder rate for complete spontaneous bowel movement (CSBM) during treatment. Patients with a mean increase of CSBM ≧1/week in comparison with their baselines are defined as responders. The secondary outcomes include responder rate during follow-up, changes of colonic transit as measured with radio-opaque markers, individual and global symptom assessments, and reported adverse effects. This study is the first study to compare a Chinese Herbal Medicine (Ma Zi Ren Wan) with a laxative that is commonly used in the clinical practice of western medicine, and with a placebo. This study will complete the investigation of Ma Zi Ren Wan for functional constipation, and should, therefore, suggest recommendations for clinical practice. Furthermore, the process of first conducting a systematic review, then implementing a dose determination study followed by a placebo-control trial, and finally, comparing traditional Chinese medicine with an active conventional medicine in a controlled trial can be a reference to other researches on Chinese medicine

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.

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.

Development of youth friendly family medicine services in Bosnia and Herzegovina: protocol for a cluster randomized controlled trial.

PubMed

Haller, Dagmar M; Narring, Françoise; Chondros, Patty; Pejic, Daliborka; Sredic, Ana; Huseinagic, Senad; Perone, Nicolas; Sanci, Lena A; Meynard, Anne

2014-01-01

Young people face many barriers in accessing health services that are responsive to their needs. The World Health Organization has led a call to develop services that address these barriers, i.e. youth-friendly health services. Addressing the needs of young people is one of the priorities of Foundation fami, an organisation working in collaboration with the Swiss Federal Department of Development and Cooperation and Geneva University Hospitals to develop quality family medicine services in Bosnia and Herzegovina. This paper describes the design of a trial to assess the effectiveness of a multifaceted intervention involving family medicine teams (primary care doctors and nurses) to improve the youth-friendliness of family medicine services in Bosnia and Herzegovina. This is a stratified cluster randomised trial with a repeated cross-sectional design involving 59 health services in 10 municipalities of the canton of Zenica in Bosnia and Herzegovina. Municipalities were the unit of randomisation: five municipalities were randomised to the intervention arm and five to a wait-list control arm. Family medicine teams in the intervention arm were invited to participate in an interactive training program about youth-friendly service principles and change processes within their service. The primary outcome was the youth-friendliness of the primary care service measured using the YFHS-WHO + questionnaire, a validated tool which young people aged 15 to 24 years complete following a family medicine consultation. A total of 600 young people aged 15 to 24 years were invited to participate and complete the YFHS-WHO + questionnaire: 300 (30 per municipality) at baseline, and 300 at follow-up, three to five months after the training program. The results of this trial should provide much awaited evidence about the development of youth-friendly primary care services and inform their further development both in Bosnia and Herzegovina and worldwide. Australian New Zealand

Clinical trial transparency: many gains but access to evidence for new medicines remains imperfect.

PubMed

Mintzes, Barbara; Lexchin, Joel; Quintano, Ancella Santos

2015-01-01

Although selective and incomplete publication is widely acknowledged to be a problem, full access to clinical trial data remains illusive. Authors' personal files, key documents from Food and Drug Administration and European Medicines Agency and focussed searches of PubMed. Existing sources of information provide an incomplete overview of scientific research. Persistent arguments about commercial confidentiality and the potential difficulties in de-identifying raw data can block important progress. Current industry efforts are voluntary and only partially satisfy the need for complete data. Requirements for trial registration are increasing. Important regulatory changes in particular in Europe have the potential to result in the release of more information. Documenting the effects of prospective trial registration and requirements for proactive clinical trial publication on healthcare decisions, public health and rational resource allocation. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

National Cancer Institute's Precision Medicine Initiatives for the new National Clinical Trials Network.

PubMed

Abrams, Jeffrey; Conley, Barbara; Mooney, Margaret; Zwiebel, James; Chen, Alice; Welch, John J; Takebe, Naoko; Malik, Shakun; McShane, Lisa; Korn, Edward; Williams, Mickey; Staudt, Louis; Doroshow, James

2014-01-01

The promise of precision medicine will only be fully realized if the research community can adapt its clinical trials methodology to study molecularly characterized tumors instead of the traditional histologic classification. Such trials will depend on adequate tissue collection, availability of quality controlled, high throughput molecular assays, and the ability to screen large numbers of tumors to find those with the desired molecular alterations. The National Cancer Institute's (NCI) new National Clinical Trials Network (NCTN) is well positioned to conduct such trials. The NCTN has the ability to seamlessly perform ethics review, register patients, manage data, and deliver investigational drugs across its many sites including both in cities and rural communities, academic centers, and private practices. The initial set of trials will focus on different questions: (1) Exceptional Responders Initiative-why do a minority of patients with solid tumors or lymphoma respond very well to some drugs even if the majority do not?; (2) NCI MATCH trial-can molecular markers predict response to targeted therapies in patients with advanced cancer resistant to standard treatment?; (3) ALCHEMIST trial-will targeted epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors improve survival for adenocarcinoma of the lung in the adjuvant setting?; and (4) Lung Cancer Master Protocol trial for advanced squamous cell lung cancer-is there an advantage to developing drugs for small subsets of molecularly characterized tumors in a single, multiarm trial design? These studies will hopefully spawn a new era of treatment trials that will carefully select the tumors that may respond best to investigational therapy.

[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.

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.

Chinese herbal medicines for hypercholesterolemia

PubMed Central

Liu, Zhao Lan; Liu, Jian Ping; Zhang, Anthony Lin; Wu, Qiong; Ruan, Yao; Lewith, George; Visconte, Denise

2011-01-01

Background Hypercholesterolemia is an important key contributory factor for ischemic heart disease and is associated with age, high blood pressure, a family history of hypercholesterolemia, and diabetes. Chinese herbal medicines have been used for a long time as lipid-lowering agents. Objectives To assess the effects of Chinese herbal medicines on hypercholesterolemia. Search strategy We searched the following databases: The Cochrane Library (issue 8, 2010), MEDLINE (until July 2010), EMBASE (until July 2010), Chinese BioMedical Database (until July 2010), Traditional Chinese Medical Literature Analysis and Retrieval System (until July 2010), China National Knowledge Infrastructure (until July 2010), Chinese VIP Information (until July 2010), Chinese Academic Conference Papers Database and Chinese Dissertation Database (until July 2010), and Allied and Complementary Medicine Database (until July 2010). Selection criteria We considered randomized controlled clinical trials in hypercholesterolemic participants comparing Chinese herbal medicines with placebo, no treatment, and pharmacological or non-pharmacological interventions. Data collection and analysis Two review authors independently extracted data and assessed the risk of bias. We resolved any disagreements with this assessment through discussion and a decision was achieved based by consensus. We assessed trials for the risk of bias against key criteria: random sequence generation, allocation concealment, blinding of participants, incomplete outcome data, selective outcome reporting and other sources of bias. Main results We included 22 randomized trials (2130 participants). The mean treatment duration was 2.3 ± 1.3 months (ranging from one to six months). Twenty trials were conducted in China and 18 trials were published in Chinese. Overall, the risk of bias of included trials was high or unclear. Five different herbal medicines were evaluated in the included trials, which compared herbs with conventional

NCI and the Precision Medicine Initiative®

Cancer.gov

NCI's activities related to precision medicine focuses on new and expanded precision medicine clinical trials; mechanisms to overcome drug resistance to cancer treatments; and developing a shared digital repository of precision medicine trials data.

Herbal medicine for low back pain.

PubMed

Gagnier, J J; van Tulder, M; Berman, B; Bombardier, C

2006-04-19

Low-back pain is a common condition and a substantial economic burden in industrialized societies. A large proportion of patients with chronic low-back pain use complementary and alternative medicine (CAM), visit CAM practitioners, or both. Several herbal medicines have been purported for use in low-back pain. To determine the effectiveness of herbal medicine for non-specific low-back pain. We searched the following electronic databases: Cochrane Complementary Medicine Field Trials Register (Issue 3, 2005), MEDLINE (1966 to July 2005), EMBASE (1980 to July 2005); checked reference lists in review articles, guidelines and retrieved trials; and personally contacted individuals with expertise in this very specialized area. We included randomized controlled trials, examining adults (over 18 years of age) suffering from acute, sub-acute or chronic non-specific low-back pain. The interventions were herbal medicines, defined as plants that are used for medicinal purposes in any form. Primary outcome measures were pain and function. Two authors (JJG & MVT) conducted the database searches. One author contacted content experts and acquired relevant citations. Full references and abstracts of the identified studies were downloaded. A hard copy was retrieved for final inclusion decisions. Methodological quality and clinical relevance were assessed separately by two individuals. Disagreements were resolved by consensus. Ten trials were included in this review. Two high quality trials examining the effects of Harpagophytum Procumbens (Devil's Claw) found strong evidence that daily doses standardized to 50 mg or 100 mg harpagoside were better than placebo for short-term improvements in pain and rescue medication. Another high quality trial demonstrated relative equivalence to 12.5 mg per day of rofecoxib (Vioxx). Two trials examining the effects of Salix Alba (White Willow Bark) found moderate evidence that daily doses standardized to 120 mg or 240 mg salicin were better than

Herbal medicines for advanced colorectal cancer.

PubMed

Guo, Zhongning; Jia, Xiaoqiang; Liu, Jian Ping; Liao, Juan; Yang, Yufei

2012-05-16

Herbal medicine has been widely used in patients with advanced colorectal cancer in China, but its efficacy has not been confirmed. To evaluate the beneficial effect and safety on Chinese herbal medicine therapy for advanced stage colorectal cancer, and it's influence on the patients' quality of life. The following electronic databases were searched: BIOSIS Previews, Cochrane Controlled Trials Register, Medline EMBASE, Biological Abstracts, until Aug. 2011. Manual searching was performed on 16 types of Chinese journals which started from their respective first publication dates, as well as unpublished conference proceedings. No language restriction was applied. Randomized or quasi-randomised controlled trials on the treatment of advanced stage colorectal cancer by herbal medicines or herbal medicines combined with chemotherapy, regardless of blinding. The data were extracted independently by two reviewers. Methodological quality of the included in trials was assessed according to the following parameters: randomisation, allocation concealment, double blinding, and drop-out rates. A total of 20 randomised controlled trials with 1304 participants were identified. All the 20 trials compared the use of herbal medicines with chemotherapy and chemotherapy alone in the treatment of advanced stage colorectal cancers.Compared with chemotherapy alone, the use of Quxie capsule combined with chemotherapy could decrease mortality rate (RR 0.17, 95% CI 0.03 to 0.97); the use of Jianpi Jiedu formula, Xiaozheng formula and Yiqi Huoxue herbal medicine combined with chemotherapy respectively could improve 1-year survival rate significantly; the use of Xiaozheng Formula in conjunction with chemotherapy could improve 3-year survival rate. There were 10 herbal medicines showing benefit in improving quality of life. Herbal medicines did not show additional benefit in response rate or stability rate. No trials reported serious adverse effect from herbal medicine. Some herbal medicines

Chinese herbal medicine for diabetic peripheral neuropathy.

PubMed

Chen, Wei; Zhang, Yin; Liu, Jian Ping

2011-06-15

Chinese herbal medicine is frequently used for treating diabetic peripheral neuropathy in China. Many controlled trials have been undertaken to investigate its efficacy. To assess the beneficial effects and harms of Chinese herbal medicine for people with diabetic peripheral neuropathy. We searched the Cochrane Neuromuscular Disease Group Specialized Register (15 June 2010), the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2010 in The Cochrane Library), MEDLINE (January 1966 to June 2010), EMBASE (January 1980 to June 2010), AMED (January 1985 to June 2010), Chinese Biomedical Database (CBM) (1979 to June 2010), Chinese National Knowledge Infrastructure Database (CNKI) (1979 to June 2010), and VIP Chinese Science and Technique Journals Database (1989 to June 2010). We searched for unpublished literature in the Chinese Conference Papers Database and Chinese Dissertation Database (from inception to March 2010). No language or publication restrictions were used. We included randomized controlled trials of Chinese herbal medicine (with a minimum of four weeks treatment duration) for people with diabetic peripheral neuropathy compared with placebo, no intervention, or conventional interventions. Trials of herbal medicine plus a conventional drug versus the drug alone were also included. Two authors independently extracted data and evaluated trial quality. We contacted study authors for additional information. The data analyses were carried out using Review Manager 5.1 (Cochrane software). Thirty-nine randomized trials involving 2890 participants were included. All trials were conducted and published in China. Thirty different herbal medicines were tested in these trials, including four single herbs (extracts from a single herb), eight traditional Chinese patent medicines, and 18 self-concocted Chinese herbal compound prescriptions. The trials reported on global symptom improvement (including improvement in numbness or pain) and changes in nerve

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

Complementary and alternative medicine: what's it all about?

PubMed

Barrett, B

2001-01-01

A number of health-related interventions--from widespread therapies such as acupuncture, herbal medicine, homeopathy and yoga, to less well-known modalities such as Feldenkrais, iridology, reflexology and reiki--have increasingly come under the general heading of complementary and alternative medicine (CAM). A few, such as biofeedback, chiropractic and physical therapy, are considered conventional by some, alternative by others. Several national surveys estimate that around 40% of the US populace uses a CAM therapy in a given year. While a few people use CAM therapies instead of conventional medicine, the vast majority of CAM users continue to access the official health care system. Many, however, do not discuss their CAM use with their physician. Medical doctors, for their part, are sharply divided on their attitudes toward CAM, with strong advocates and vehement opponents writing and speaking about this issue. CAM therapists are even more diverse, spanning the spectrum from conventional-appearing registered and certified practitioners to iconoclasts promoting anomalous therapies in the place of conventional treatment. The majority, however, both respect and want to work with conventional medicine, as do their patients. Nearly everyone is calling for more and better evidence, and an ever-increasing number of randomized controlled trials and meta-analyses are now appearing in the literature. Over the past few years, a number of calls for "integrated medicine" have been made, and a few attempts at integrating CAM and conventional medicine have been launched. This article reviews these issues, citing our own interview-based work and the relevant literature. Whether the CAM phenomenon represents a short-lived social movement or the beginnings of a radical transformation of medicine has yet to be determined.

Large Cancer Drug Trial Helps Move Precision Medicine Toward the Mainstream | Frederick National Laboratory for Cancer Research

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

eLaunch Hypersonics: An Advanced Launch System

NASA Technical Reports Server (NTRS)

Starr, Stanley

2010-01-01

This presentation describes a new space launch system that NASA can and should develop. This approach can significantly reduce ground processing and launch costs, improve reliability, and broaden the scope of what we do in near earth orbit. The concept (not new) is to launch a re-usable air-breathing hypersonic vehicle from a ground based electric track. This vehicle launches a final rocket stage at high altitude/velocity for the final leg to orbit. The proposal here differs from past studies in that we will launch above Mach 1.5 (above transonic pinch point) which further improves the efficiency of air breathing, horizontal take-off launch systems. The approach described here significantly reduces cost per kilogram to orbit, increases safety and reliability of the boost systems, and reduces ground costs due to horizontal-processing. Finally, this approach provides significant technology transfer benefits for our national infrastructure.

Launch Order, Launch Separation, and Loiter in the Constellation 1 1/2-Launch Solution

NASA Technical Reports Server (NTRS)

Stromgren, Chel; Cates, Grant; Cirillo, William

2009-01-01

The NASA Constellation Program (CxP) is developing a two-element Earth-to-Orbit launch system to enable human exploration of the Moon. The first element, Ares I, is a human-rated system that consists of a first stage based on the Space Shuttle Program's solid rocket booster (SRB) and an upper stage that consists of a four-crew Orion capsule, a service module, and a Launch Escape System. The second element, Ares V, is a Saturn V-plus category launch system that consists of the core stage with a cluster of six RS-68B engines and augmented with two 5.5-segment SRBs, a Saturn-derived J-2X engine powering an Earth Departure Stage (EDS), and the lunar-lander vehicle payload, Altair. Initial plans called for the Ares V to be launched first, followed the next day by the Ares I. After the EDS performs the final portion of ascent and subsequent orbit circularization, the Orion spacecraft then performs a rendezvous and docks with the EDS and its Altair payload. Following checkout, the integrated stack loiters in low Earth orbit (LEO) until the appropriate Trans-Lunar Injection (TLI) window opportunity opens, at which time the EDS propels the integrated Orion Altair to the Moon. Successful completion of this 1 1/2-launch solution carries risks related to both the orbital lifetime of the assets and the probability of achieving the launch of the second vehicle within the orbital lifetime of the first. These risks, which are significant in terms of overall system design choices and probability of mission success, dictated a thorough reevaluation of the launch strategy, including the order of vehicle launch and the planned time period between launches. The goal of the effort described in this paper was to select a launch strategy that would result in the greatest possible expected system performance, while accounting for launch risks and the cost of increased orbital lifetime. Discrete Event Simulation (DES) model of the launch strategies was created to determine the probability

66. DETAIL OF LAUNCH CONDUCTOR AND ASSISTANT LAUNCH CONDUCTOR PANELS ...

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

66. DETAIL OF LAUNCH CONDUCTOR AND ASSISTANT LAUNCH CONDUCTOR PANELS IN CONSOLE LOCATED CENTRALLY IN SLC-3E CONTROL ROOM. FROM LEFT TO RIGHT IN BACKGROUND: LAUNCH OPERATOR, LAUNCH ANALYST, AND FACILITIES PANELS. - Vandenberg Air Force Base, Space Launch Complex 3, Launch Operations Building, Napa & Alden Roads, Lompoc, Santa Barbara County, CA

Chinese herbal medicine for diabetic peripheral neuropathy.

PubMed

Chen, Wei; Zhang, Yin; Li, Xinxue; Yang, Guoyan; Liu, Jian Ping

2013-10-06

Chinese herbal medicine is frequently used for treating diabetic peripheral neuropathy in China. Many controlled trials have been undertaken to investigate its efficacy.This is an update of a Cochrane review that was first published in the year 2011. To assess the beneficial effects and harms of Chinese herbal medicine for people with diabetic peripheral neuropathy. On 14 May 2012, we searched the Cochrane Neuromuscular Disease Group Specialized Register CENTRAL (2012, Issue 4 in The Cochrane Library), MEDLINE (January 1966 to May 2012), EMBASE (January 1980 to May 2012), AMED (January 1985 to May 2012) and in October 2012, the Chinese Biomedical Database (CBM) (1979 to October 2012), Chinese National Knowledge Infrastructure Database (CNKI) (1979 to October 2012), and VIP Chinese Science and Technique Journals Database (1989 to October 2012). We searched for unpublished literature in the Chinese Conference Papers Database, and Chinese Dissertation Database (from inception to October 2012). There were no language or publication restrictions. We included randomised controlled trials of Chinese herbal medicine (with a minimum of four weeks treatment duration) for people with diabetic peripheral neuropathy compared with placebo, no intervention, or conventional interventions. Trials of herbal medicine plus a conventional drug versus the drug alone were also included. Two authors independently extracted data and evaluated trial quality. We contacted study authors for additional information. Forty-nine randomised trials involving 3639 participants were included. All trials were conducted and published in China. Thirty-eight different herbal medicines were tested in these trials, including four single herbs (extracts from a single herb), eight traditional Chinese patent medicines, and 26 self concocted Chinese herbal compound prescriptions. The trials reported on global symptom improvement (including improvement in numbness or pain) and changes in nerve conduction

Chinese herbal medicines for unexplained recurrent miscarriage.

PubMed

Li, Lu; Dou, Lixia; Leung, Ping Chung; Chung, Tony Kwok Hung; Wang, Chi Chiu

2016-01-14

Recurrent miscarriage affects 1% to 3% of women of reproductive age and mostly occurs before the 10th week of gestation (and around the same gestational week in subsequent miscarriages). Although most pregnant women may not recognise a miscarriage until uterine bleeding and cramping occur, a repeat miscarriage after one or more pregnancy loss and the chance of having a successful pregnancy varies. To date, there is no universally accepted treatment for unexplained recurrent miscarriage. Chinese herbal medicines have been widely used in Asian societies for millennia and have become a popular alternative to Western medicines in recent years. Many clinical studies have reported that Chinese herbal medicines can improve pregnancy outcomes for pregnant women who had previously suffered recurrent miscarriage. This systematic review evaluated the efficacy of Chinese herbal medicines for recurrent miscarriage. To assess the effectiveness and safety of Chinese herbal medicines for the treatment of unexplained recurrent miscarriage. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (01 June 2015), Embase (1980 to 01 June 2015); Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982 to 01 June 2015); Chinese Biomedical Database (CBM) (1978 to 01 June 2015); China Journal Net (CJN) (1915 to 01 June 2015); China Journals Full-text Database (1915 to 01 June 2015); and WanFang Database (Chinese Ministry of Science & Technology) (1980 to 01 June 2015). We also searched reference lists of relevant trials and reviews. We identified and contacted organisations, individual experts working in the field, and medicinal herb manufacturers. Randomised or quasi-randomised controlled trials, including cluster-randomised trials, with or without full text, comparing Chinese herbal medicines (alone or combined with other intervention or other pharmaceuticals) with placebo, no treatment, other intervention (including bed rest and psychological support

Patient recruitment for clinical trials on traditional Chinese medicine: Challenges, barriers, and strategies.

PubMed

King-Fai, Cheng; Ping-Chung, Leung; Lai-Yi, Wong; Yuet-Shim, Fong

2008-02-02

Failure to recruit sufficient numbers of participants is a major barrier to the completion of randomized controlled trials in traditional Chinese medicine (TCM) clinical trials. The purpose of this paper is to analyze the commonly used strategies for the recruitment of patients in TCM clinical trials, to identify the most common reasons for attrition and refusal, and to identify barriers and potential solutions to the difficulties. There are four stages in the actual recruitment process, which included introducing the project to the potential patients, explaining how to implement the project, assessing and intensifying the understanding and facilitating patient decision-making. When insufficient recruitment occurred, the following steps should be considered: reevaluating the required sample size; adding new sites to the trial; eliminating hospitals that had poor recruiting records; extending the patient recruitment period, modifying the patient inclusion/exclusion criteria; and shifting placebo-controlled to active-controlled arrangements. Success in reaching target recruitment depended largely on being able to directly contact patients through posters, newspaper advertisements, television interviews, patient support groups, and physician referrals in hospitals. Suspicions against the placebo and unwillingness to stop taking other herbal supplements made recruitment more difficult, time-consuming, and costly. In a Chinese community, open advertising in the local newspaper may be particularly attractive.

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

Use of electronic healthcare records in large-scale simple randomized trials at the point of care for the documentation of value-based medicine.

PubMed

van Staa, T-P; Klungel, O; Smeeth, L

2014-06-01

A solid foundation of evidence of the effects of an intervention is a prerequisite of evidence-based medicine. The best source of such evidence is considered to be randomized trials, which are able to avoid confounding. However, they may not always estimate effectiveness in clinical practice. Databases that collate anonymized electronic health records (EHRs) from different clinical centres have been widely used for many years in observational studies. Randomized point-of-care trials have been initiated recently to recruit and follow patients using the data from EHR databases. In this review, we describe how EHR databases can be used for conducting large-scale simple trials and discuss the advantages and disadvantages of their use. © 2014 The Association for the Publication of the Journal of Internal Medicine.

Canadian Space Launch: Exploiting Northern Latitudes For Efficient Space Launch

DTIC Science & Technology

2015-04-01

9  Peoples’ Republic of China .........................................................................................11  USA Launch... taxation and legislation that make Canada an attractive destination for commercial space companies.3 General Definitions Highly Inclined Orbit...launches from sites north of the 35th parallel.33 USA Launch Facilities There are 3 US based launch facilities that conduct launch operations north

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

The efficacy of the Kampo medicine rikkunshito for chemotherapy-induced anorexia (RICH trial): study protocol for a randomized controlled trial.

PubMed

Inoue, Takuya; Takagi, Hironori; Owada, Yuki; Watanabe, Yuzuru; Yamaura, Takumi; Fukuhara, Mitsuro; Muto, Satoshi; Okabe, Naoyuki; Matsumura, Yuki; Hasegawa, Takeo; Osugi, Jun; Hoshino, Mika; Higuchi, Mitsunori; Shio, Yutaka; Yokouchi, Hiroshi; Kanazawa, Kenya; Ohbuchi, Katsuya; Fukushima, Takahisa; Munakata, Mitsuru; Suzuki, Hiroyuki

2017-10-18

Cisplatin is a key drug in lung cancer therapy. However, cisplatin is also well known to induce gastrointestinal disorders, such as chemotherapy-induced nausea and vomiting, anorexia, and weight loss. These symptoms sometimes affect patients' quality of life and make continuation of chemotherapy difficult. Anorexia is a cause of concern for patients with cancer because a persistent loss of appetite progresses to cancer cachexia. Although evidence-based management for chemotherapy has recently been established, there is room for improvement. This placebo-controlled, double-blind, randomized trial will aim to determine the efficacy of the traditional Japanese Kampo medicine rikkunshito (TJ-43) for preventing anorexia caused by cisplatin-including chemotherapy in patients with lung cancer. Patients with lung cancer who plan to receive cisplatin-including chemotherapy will be recruited. Patients who provide written consent will be randomly allocated to receive either TJ-43 (arm A) or placebo (arm B) for one course of chemotherapy (21 or 28 consecutive days). Investigators and patients will be masked to the treatment assignment throughout the trial. The primary endpoint will be evaluated as the change in dietary intake from day 0 (the day before the start of chemotherapy) to day 7 of cisplatin-including chemotherapy. The two arms of the trial will comprise 30 patients each. From November 2014, a total of 60 patients will be recruited, and recruitment for the study is planned to be complete by October 2017. This trial is designed to examine the efficacy of rikkunshito (TJ-43) for reducing anorexia and maintaining food intake caused by cisplatin-including chemotherapy in patients with lung cancer. Japan Pharmaceutical Information Center Clinical Trials Information (JAPIC CTI), trial registration: JAPIC CTI-142747 . Registered on 15 December 2014; the RICH trial.

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.

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.

Chinese herbal medicines for hyperthyroidism.

PubMed

Zen, X X; Yuan, Y; Liu, Y; Wu, T X; Han, S

2007-04-18

Hyperthyroidism is a disease in which excessive amounts of thyroid hormones circulate in the blood. Patients, among other things suffer from tachycardia, warm moist skin and raised body temperature. The treatment of hyperthyroidism includes symptom relief and therapy with antithyroid medications, radioiodine and thyroidectomy. Medicinal herbs are used alone or in combination with antithyroid agents to treat hyperthyroidism in China and some other countries. To assess the effects of Chinese herbal medicines for treating hyperthyroidism. Studies were obtained from computerised searches of MEDLINE, EMBASE, The Cochrane Library, the Chinese Biomedical Database. Randomised controlled trials comparing the effects of Chinese herbal medicines alone with Chinese herbal medicines combined with antithyroid drugs, radioiodine or both. Three authors interviewed authors of all potentially relevant studies by telephone to verify randomisation procedures. One author entered data into a data extraction form and another author verified the results of this procedure. Thirteen relevant trials with 1770 participants were included. All of them were of low quality. Fifty-two studies still need to be assessed because the original authors could not be interviewed. None of these trials analysed mortality, health related quality of life, economic outcomes or compliance. Compared to antithyroid drugs alone the results showed that Chinese herbal medicines combined with antithyroid drugs may offer benefits in lowering relapse rates, reducing the incidence of adverse effects, relieving symptoms, improving thyroid antibody status and thyroid function. Two trials investigated Chinese herbal medicine versus radioiodine and reported improvements in anxiety, tachycardia and heat intolerance. However, thyroid function - with the exception of restored thyroid stimulating hormone (TSH) - was not significantly altered. The results suggest that traditional Chinese herbal medicines added to other routine

European Union. Ethical considerations for clinical trials on medicinal products conducted with the paediatric population.

PubMed

2008-07-01

This document has been developed by the ad hoc group for the development of implementing guidelines for Directive 2001/20/EC relating to good clinical practice in the conduct of clinical trials on medicinal products for human use, chaired by the European Commission. The document provides recommendations on various ethical aspects of clinical trials performed in children from birth up to the legal age of adulthood. This will contribute to the protection of all children who are the subject of clinical trials. As the approval of clinical trials, including ethical approval, is performed by the Member States, any recommendations on ethical aspects of clinical trials in children will also facilitate a harmonised approach to the application of the clinical trials directive across the EU, thereby facilitating the conduct of clinical trials in the EU and in whichever country the paediatric trial occurs. The protection against the risks of research in such a vulnerable population is paramount whilst this should not lead to denying them the benefits of research. Children are not small adults and there is a need to carry out specific trials that cannot be performed in adults. In general, children (minors) are unable to consent (in the legal sense) but their assent should be sought using age appropriate information. Ethics Committees need paediatric expertise to balance the benefits and risks of research in children. The lack of legal ability to consent has implications on the design, analysis and the choice of comparators used in trials, which should only be performed by trained investigators with paediatric experience. Pain, fear, distress and parental separation should be prevented and minimised when unavoidable. The neonate represents the most vulnerable of all paediatric age groups and requires even more careful review. Finally, various other aspects relating to the performance of trials in children are discussed.

The changing face of clinical trials in the personalized medicine and immuno-oncology era: report from the international congress on clinical trials in Oncology & Hemato-Oncology (ICTO 2017).

PubMed

Golan, Talia; Milella, Michele; Ackerstein, Aliza; Berger, Ranaan

2017-12-28

In the past decade, the oncology community has witnessed major advances in the understanding of cancer biology and major breakthroughs in several different therapeutic areas, from solid tumors to hematological malignancies; moreover, the advent of effective immunotherapy approaches, such as immune-checkpoint blockade, is revolutionizing treatment algorithms in almost all oncology disease areas. As knowledge evolves and new weapons emerge in the "war against cancer", clinical and translational research need to adapt to a rapidly changing environment to effectively translate novel concepts into sustainable and accessible therapeutic options for cancer patients.With this in mind, translational cancer researchers, oncology professionals, treatment experts, CRO and industry leaders, as well as patient representatives gathered in London, 16-17 March 2017, for The International Congress on Clinical Trials in Oncology and Hemato-Oncology (ICTO2017), to discuss the changing face of oncology clinical trials in the new era of personalized medicine and immuno-oncology. A wide range of topics, including clinical trial design in immuno-oncology, biomarker-oriented drug development paths, statistical design and endpoint selection, challenges in the design and conduct of personalized medicine clinical trials, risk-based monitoring, financing and reimbursement, as well as best operational practices, were discussed in an open, highly interactive format, favoring networking among all relevant stakeholders. The most relevant data, approaches and issues emerged and discussed during the conference are summarized in this report.

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

First night launch of a Saturn I launch vehicle

NASA Image and Video Library

1965-05-25

First night time launching of a Saturn I launch vehicle took place at 2:35 a.m., May 25, 1965, with the launch of the second Pegasus meteoroid detection satellite from Complex 37, Cape Kennedy, Florida.

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

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

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

Searching for controlled trials of complementary and alternative medicine: a comparison of 15 databases.

PubMed

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.

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

Launch Preparation and Rocket Launching

DTIC Science & Technology

1991-05-23

which do not exceed several hundred kilometers. In the USA MBR and heavy rocket carriers to distant distances are transported predominantly on air or...Balloon for transportation of MBR "Minuteman" (drawing): - balloon; 2 - rocket. DOC = 91032701 PAGE 34 Page 20. Thus, for the protection from the axial g...launching is suitable for rockets, launched from surface of the earth (water), or from silo (submarine in submerged state). The selection of

The Launch of an Atlas/Centaur Launch Vehicle

NASA Technical Reports Server (NTRS)

1978-01-01

The launch of an Atlas/Centaur launch vehicle is shown in this photograph. The Atlas/Centaur, launched on November 13, 1978, carried the High Energy Astronomy Observatory (HEAO)-2 into the required orbit. The second observatory, the HEAO-2 (nicknamed the Einstein Observatory in honor of the centernial of the birth of Albert Einstein) carried the first telescope capable of producing actual photographs of x-ray objects.

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.

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

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

Acupuncture paired with herbal medicine for prediabetes: study protocol for a randomized controlled trial.

PubMed

Li, Xinger; Liu, Haiyan; Feng, Huiping; Xian, Zhongren; Chen, Yanhong; Chen, Jianping; Tang, Chunzhi; Lai, Xinsheng; Lan, Xiaoling; Huang, Huanzhen; Yu, Dongdong

2017-06-28

Type-2 diabetes has become a major disease and is known to seriously impair people's health worldwide. Prediabetes includes impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) and is the most critical period for preventing type-2 diabetes, as it can be identified and reversed. Studies in the past decade have indicated that acupuncture and Chinese herbal medicine may be beneficial for treating prediabetes. However, a randomized controlled trial (RCT) should be conducted to obtain more clinical evidence on this topic. An RCT will be implemented in this study, using a72-week study period (24 weeks for the intervention and 48 weeks for follow-up). Participants will be recruited from the Fifth Affiliated Hospital of Guangzhou Medical University in China. Eighty participants will be randomized to the treatment group (acupuncture plus herbal medicine and health education) or the control group (health education only), 40 participants in each. People included in this study must have been diagnosed with prediabetes using Western medicine criteria. The endpoint indices include the incidence of diabetes mellitus and the reversion rate. The primary outcome is fasting plasma glucose (FPG) level, 2-h plasma glucose (2-hPG) level after a 75-g oral glucose tolerance test (OGTT), and glycosylated hemoglobin (HbA 1c ) level. Secondary outcomes include the following: Body Mass Index (BMI); hemorheology, including shear rates of whole-blood viscosity and plasma viscosity. Safety indices include hepatic (ALT, AST) and renal function (BUN, Cr) and records of adverse events, including diarrhoea, colds, pharyngitis, and sleep disorders. Quality control will be implemented, including quality control of the laboratory, researchers, participants, investigational drugs, data and documents, occurrence of bias, supervision, among others, according to uniform standard operating procedures (SOPs) which have been established by the Good Clinical Practice (GCP) office of the Fifth

U.S. & international small launch vehicles : Quarterly Launch Report : special report

DOT National Transportation Integrated Search

1998-01-01

Since the 1980s, there have been expectations that a substantial commercial market for launch services using small launch vehicles would develop. In fact, commercial launches of small launch vehicles have, in theory, been available since the mid-1980...

Herbal medicine for low back pain: a Cochrane review.

PubMed

Gagnier, Joel J; van Tulder, Maurits W; Berman, Brian; Bombardier, Claire

2007-01-01

A systematic review of randomized controlled trials. To determine the effectiveness of herbal medicine compared with placebo, no intervention, or "standard/accepted/conventional treatments" for nonspecific low back pain. Low back pain is a common condition and a substantial economic burden in industrialized societies. A large proportion of patients with chronic low back pain use complementary and alternative medicine (CAM) and/or visit CAM practitioners. Several herbal medicines have been purported for use in low back pain. The following databases were searched: Medline (1966 to April 2003), Embase (1980 to April 2003), Cochrane Controlled Trials Register (Issue 1, 2003), and Cochrane Complementary Medicine (CM) field Trials Register. Additionally, reference lists in review articles, guidelines, and in the retrieved trials were checked. Randomized controlled trials (RCTs), using adults (>18 years of age) suffering from acute, subacute, or chronic nonspecific low back pain. Types of interventions included herbal medicines defined as a plant that is used for medicinal purposes in any form. Primary outcome measures were pain and function. Two reviewers (J.J.G. and M.W.T.) conducted electronic searches in all databases. One reviewer (J.J.G.) contacted content experts and acquired relevant citations. Authors, title, subject headings, publication type, and abstract of the isolated studies were downloaded or a hard copy was retrieved. Methodologic quality and clinical relevance were assessed separately by two individuals (J.J.G. and M.W.T.). Disagreements were resolved by consensus. Ten trials were included in this review. Two high-quality trials utilizing Harpagophytum procumbens (Devil's claw) found strong evidence for short-term improvements in pain and rescue medication for daily doses standardized to 50 mg or 100 mg harpagoside with another high-quality trial demonstrating relative equivalence to 12.5 mg per day of rofecoxib. Two moderate-quality trials utilizing

Heart rate and pulmonary function while wearing the launch-entry crew escape suit (LES) during + Gx acceleration and simulated Shuttle launch

NASA Technical Reports Server (NTRS)

Krutz, Robert W., Jr.; Bagian, James P.; Burton, Russell R.; Meeker, Larry J.

1990-01-01

Space shuttle crewmembers have been equipped with a launch-entry crew escape system (LES) since the Challenger accident in 1986. Some crewmembers, wearing the new pressure suit, have reported breathing difficulties and increased effort to achieve the desired range of motion. This study was conducted to quantify the reported increased physical workloads and breathing difficulty associated with wearing the LES. Both veteran astronauts and centrifuge panel members were exposed to various + Gx profiles (including simulated shuttle launch) + Gx on the USAF School of Aerospace Medicine (USAFSAM) human-use centrifuge. Maximum heart rate data showed no increased workload associated with arm and head movement in the LES when compared to the flight suit/helmet ensemble (LEH). However, the LES did impose a significant increase in breathing difficulty beginning at +2.5 Gx which was demonstrated by a decrease in forced vital capacity and subjected questionnaries.

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

PubMed

Cui, Xue-Jun; Sun, Yue-Li; You, Sheng-Fu; Mo, Wen; Lu, Sheng; Shi, Qi; Wang, Yong-Jun

2013-10-07

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. 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. 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 would like to publish the results and

4. GENERAL VIEW OF LAUNCH PAD B FROM LAUNCH PAD ...

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

4. GENERAL VIEW OF LAUNCH PAD B FROM LAUNCH PAD A MOBILE SERVICE STRUCTURE; VIEW TO SOUTH. - Cape Canaveral Air Station, Launch Complex 17, Facility 28402, East end of Lighthouse Road, Cape Canaveral, Brevard County, FL

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

14 CFR 420.29 - Launch site location review for unproven launch vehicles.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LICENSE TO OPERATE A LAUNCH SITE Criteria and Information Requirements for Obtaining a License § 420.29 Launch site location review for unproven launch vehicles. An applicant for a license to operate a launch site for an unproven launch vehicle shall...

14 CFR 420.29 - Launch site location review for unproven launch vehicles.

Code of Federal Regulations, 2010 CFR

2010-01-01

... AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LICENSE TO OPERATE A LAUNCH SITE Criteria and Information Requirements for Obtaining a License § 420.29 Launch site location review for unproven launch vehicles. An applicant for a license to operate a launch site for an unproven launch vehicle shall...

An evaluation of the completeness of safety reporting in reports of complementary and alternative medicine trials

PubMed Central

2011-01-01

Background Adequate reporting of safety in publications of randomized controlled trials (RCTs) is a pre-requisite for accurate and comprehensive profile evaluation of conventional as well as complementary and alternative medicine (CAM) treatments. Clear and concise information on the definition, frequency, and severity of adverse events (AEs) is necessary for assessing the benefit-harm ratio of any intervention. The objectives of this study are to assess the quality of safety reporting in CAM RCTs; to explore the influence of different trial characteristics on the quality of safety reporting. Methods Survey of safety reporting in RCTs published in 2009 across 15 widely used CAM interventions identified from the Cochrane Collaboration's CAM Field specialized register of trials. Primary outcome measures, the adequacy of reporting of AEs; was defined and categorized according to the CONSORT for harms extension; the percentage of words devoted to the reporting of safety in the entire report and in the results section. Results Two-hundred and five trials were included in the review. Of these, 15% (31/205) reported that no harms were observed during the trial period. Of the remaining 174 trials reporting any safety information, only 21% (36/174) had adequate safety reporting. For all trials, the median percentage of words devoted to the reporting of safety in the results section was 2.6. Moreover, 69% (n = 141) of all trials devoted a lesser or equal percentage of words to safety compared to author affiliations. Of the predictor variables used in regression analysis, multicenter trials had more words devoted to safety in the results section than single centre trials (P = 0.045). Conclusions An evaluation of safety reporting in the reports of CAM RCTs across 15 different CAM interventions demonstrated that the reporting of harms was largely inadequate. The quality of reporting safety information in primary reports of CAM randomized trials requires improvement. PMID

Randomized Placebo-Controlled Double-Blind Clinical Trial of Cannabis-Based Medicinal Product (Sativex) in Painful Diabetic Neuropathy

PubMed Central

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

2010-01-01

OBJECTIVE To assess the efficacy of Sativex, a cannabis-based medicinal extract, as adjuvant treatment in painful diabetic peripheral neuropathy (DPN). RESEARCH DESIGN AND METHODS 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. RESULTS 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. CONCLUSIONS 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. PMID:19808912

Licensing of commercial launch sites : Quarterly Launch Report : special report :

DOT National Transportation Integrated Search

2000-01-01

The Commercial Space Launch Act of 1984 as recodified at 49 U.S.C. Subtitle IX--Commercial Space Transportation, ch. 701, Commercial Space Launch Activities, 49 U.S.C. '' 70101- authorizes the Secretary of Transportation to license launches or the op...

U.S. small launch vehicles : Quarterly Launch Report : special report

DOT National Transportation Integrated Search

1996-01-01

1995 was an ambitious and difficult year for the United States small launch vehicle market. A total of five small launch vehicles were launched from the United States, two of which were successful (Atlas : E and Pegasus 1) and three of which resulted...

Launch of Agena Target Docking Vehicle atop Atlas launch vehicle

NASA Technical Reports Server (NTRS)

1966-01-01

An Agena Target Docking Vehicle atop its Atlas launch vehicle was launched fromt the Kennedy Space Center's Launch Complex 14 at 6:05 a.m., September 12, 1966. The Agena served as a rendezvous and docking vehicle for the Gemini 11 spacecraft.

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

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.

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

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.

Assessment of the methodological and ethical quality of clinical trials published in family medicine journals

PubMed

Castaño-García, Alberto; Guillén-Grima, Francisco; León-Sanz, Pilar

2018-01-01

To evaluate some methodological and ethical quality variables of clinical trials (CTs) published in 10 family medicine journals. Quality descriptive study of 10 family medicine journals including CTs in humans published since 2010 to 2013. We obtained 141 CT and 2447 were excluded. CTs parallels controlled in 92.9% (95% confidence interval [95% CI]: 92.0-93.9). Masked randomization in 72.3% (95% CI: 71.7-73.1), decentralized in 51.8% (95% CI: 51.4-52.4) and using as control an active treatment in 82.2% (95% CI: 81.5-83.1). Wrote informed consent in 48.9% (95% CI: 48.5-49.5) and it was not withdrawn in 56.0% of cases (95% CI: 55.5-56.7). Approval by clinical research ethics committee (CREC) in 134, and there was no conflict of interest in 117 CTs. Average κ was 0.96 (95% CI: 0.93-0.99). We observe an increase in some quality variables like masked randomization (19.6%) and approval by CREC (75%) post CONSORT, in CTs published in 10 family medicine journals (2010-2013). Copyright: © 2018 SecretarÍa de Salud

Precision Medicine and the Changing Landscape of Research Ethics.

PubMed

Hammer, Marilyn J

2016-03-01

President Barack Obama announced the launch of the National Institutes of Health Precision Medicine Initiative® (PMI) in January 2015. Precision medicine includes the concept of individualized or personalized medicine at a more exact level through advances in science and technology, such as genetics and genomics sequencing. Although many disease processes will be investigated through the precision medicine lens for greater understanding and improved treatment responses, oncology research and translation to practice is leading the initiative's debut, referred to as the near-term focus.

Enhancing Insights into Pulmonary Vascular Disease through a Precision Medicine Approach. A Joint NHLBI-Cardiovascular Medical Research and Education Fund Workshop Report.

PubMed

Newman, John H; Rich, Stuart; Abman, Steven H; Alexander, John H; Barnard, John; Beck, Gerald J; Benza, Raymond L; Bull, Todd M; Chan, Stephen Y; Chun, Hyung J; Doogan, Declan; Dupuis, Jocelyn; Erzurum, Serpil C; Frantz, Robert P; Geraci, Mark; Gillies, Hunter; Gladwin, Mark; Gray, Michael P; Hemnes, Anna R; Herbst, Roy S; Hernandez, Adrian F; Hill, Nicholas S; Horn, Evelyn M; Hunter, Kendall; Jing, Zhi-Cheng; Johns, Roger; Kaul, Sanjay; Kawut, Steven M; Lahm, Tim; Leopold, Jane A; Lewis, Greg D; Mathai, Stephen C; McLaughlin, Vallerie V; Michelakis, Evangelos D; Nathan, Steven D; Nichols, William; Page, Grier; Rabinovitch, Marlene; Rich, Jonathan; Rischard, Franz; Rounds, Sharon; Shah, Sanjiv J; Tapson, Victor F; Lowy, Naomi; Stockbridge, Norman; Weinmann, Gail; Xiao, Lei

2017-06-15

The Division of Lung Diseases of the NHLBI and the Cardiovascular Medical Education and Research Fund held a workshop to discuss how to leverage the anticipated scientific output from the recently launched "Redefining Pulmonary Hypertension through Pulmonary Vascular Disease Phenomics" (PVDOMICS) program to develop newer approaches to pulmonary vascular disease. PVDOMICS is a collaborative, protocol-driven network to analyze all patient populations with pulmonary hypertension to define novel pulmonary vascular disease (PVD) phenotypes. Stakeholders, including basic, translational, and clinical investigators; clinicians; patient advocacy organizations; regulatory agencies; and pharmaceutical industry experts, joined to discuss the application of precision medicine to PVD clinical trials. Recommendations were generated for discussion of research priorities in line with NHLBI Strategic Vision Goals that include: (1) A national effort, involving all the stakeholders, should seek to coordinate biosamples and biodata from all funded programs to a web-based repository so that information can be shared and correlated with other research projects. Example programs sponsored by NHLBI include PVDOMICS, Pulmonary Hypertension Breakthrough Initiative, the National Biological Sample and Data Repository for PAH, and the National Precision Medicine Initiative. (2) A task force to develop a master clinical trials protocol for PVD to apply precision medicine principles to future clinical trials. Specific features include: (a) adoption of smaller clinical trials that incorporate biomarker-guided enrichment strategies, using adaptive and innovative statistical designs; and (b) development of newer endpoints that reflect well-defined and clinically meaningful changes. (3) Development of updated and systematic variables in imaging, hemodynamic, cellular, genomic, and metabolic tests that will help precisely identify individual and shared features of PVD and serve as the basis of novel

Herbal Medicine for Low Back Pain: A Cochrane Review.

PubMed

Gagnier, Joel J; Oltean, Hanna; van Tulder, Maurits W; Berman, Brian M; Bombardier, Claire; Robbins, Christopher B

2016-01-01

Systematic review of randomized controlled trials (RCTs). To determine the effectiveness of herbal medicine for nonspecific low back pain (LBP). Many people with chronic LBP use complementary and alternative medicine (CAM), visit CAM practitioners, or both. Several herbal medicines have been purported for use in treating people with LBP. This is an update of a Cochrane Review first published in 2006. We searched numerous electronic databases up to September 2014; checked reference lists in review articles, guidelines and retrieved trials; and personally contacted individuals with expertise in this area. We included RCTs examining adults (over 18 years of age) suffering from acute, sub-acute, or chronic nonspecific LBP. The interventions were herbal medicines that we defined as plants used for medicinal purposes in any form. Primary outcome measures were pain and function. Two review authors assessed risk of bias, GRADE criteria (GRADE 2004), and CONSORT compliance and a random subset were compared with assessments by a third individual. Two review authors assessed clinical relevance and resolved any disagreements by consensus. Fourteen RCTs (2050 participants) were included. Capsicum frutescens (cayenne) reduces pain more than placebo. Although Harpagophytum procumbens (devil's claw), Salix alba (white willow bark), Symphytum officinale L. (comfrey), Solidago chilensis (Brazilian arnica), and lavender essential oil also seem to reduce pain more than placebo, evidence for these substances was of moderate quality at best. No significant adverse events were noted within the included trials. Additional well-designed large trials are needed to test these herbal medicines against standard treatments. In general, the completeness of reporting in these trials was poor. Trialists should refer to the CONSORT statement extension for reporting trials of herbal medicine interventions. N/A.

Agena Target Vehicle atop Atlas Launch vehicle launched from KSC

NASA Technical Reports Server (NTRS)

1966-01-01

An Agena Target Vehicle atop its Atlas Launch vehicle is launched from the Kennedy Space Center (KSC) Launch Complex 14 at 10:15 am.m., May 17, 1966. The Agena was intended as a rendezvous and docking vehicle for the Gemini 9 spacecraft. However, since the Agena failed to achieve orbit, the Gemini 9 mission was postponed.

Herbal medicine for low-back pain.

PubMed

Oltean, Hanna; Robbins, Chris; van Tulder, Maurits W; Berman, Brian M; Bombardier, Claire; Gagnier, Joel J

2014-12-23

Low-back pain (LBP) is a common condition and imposes a substantial economic burden upon people living in industrialized societies. A large proportion of people with chronic LBP use complementary and alternative medicine (CAM), visit CAM practitioners, or both. Several herbal medicines have been purported for use in treating people with LBP. This is an update of a Cochrane Review first published in 2006. To determine the effectiveness of herbal medicine for non-specific LBP. We searched the following electronic databases up to September 2014: MEDLINE, EMBASE, CENTRAL, CINAHL, Clinical Trials.gov, World Health Organization International Clinical Trials Registry Portal and PubMed; checked reference lists in review articles, guidelines and retrieved trials; and personally contacted individuals with expertise in this area. We included randomized controlled trials (RCTs) examining adults (over 18 years of age) suffering from acute, sub-acute, or chronic non-specific LBP. The interventions were herbal medicines which we defined as plants used for medicinal purposes in any form. Primary outcome measures were pain and function. A library scientist with the Cochrane Back Review Group conducted the database searches. One review author contacted content experts and acquired relevant citations. We downloaded full references and abstracts of the identified studies and retrieved a hard copy of each study for final inclusion decisions. Two review authors assessed risk of bias, GRADE criteria (GRADE 2004), and CONSORT compliance and a random subset were compared to assessments by a third individual. Two review authors assessed clinical relevance and resolved any disagreements by consensus. We included 14 RCTs (2050 participants) in this review. One trial on Solidago chilensis M. (Brazilian arnica) (20 participants) found very low quality evidence of reduction in perception of pain and improved flexibility with application of Brazilian arnica-containing gel twice daily as compared

[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.

[Some problems of space medicine].

PubMed

Gurovskiĭ, N N; Egorov, A D

1976-01-01

The paper discusses the problems to be resolved by space medicine and the main stages in the development of this branch of science, beginning with the vertical launches of rockets and ending with the flights of orbital stations. On the basis of ground-based simulation experiments and real space flights it presents a classification of the major symptomocomplexes that may occur inflight. The paper describes the main stages of adaptation to weightlessness and physiological changes in the weightless state. The paper also outlines further pathways in the development of space medicine.

Launch Vehicles

NASA Image and Video Library

1990-06-01

The Delta II expendable launch vehicle with the ROSAT (Roentgen Satellite), cooperative space X-ray astronomy mission between NASA, Germany and United Kingdom, was launched from the Cape Canaveral Air Force Station on June 1, 1990.

[An investigation of the statistical power of the effect size in randomized controlled trials for the treatment of patients with type 2 diabetes mellitus using Chinese medicine].

PubMed

Ma, Li-Xin; Liu, Jian-Ping

2012-01-01

To investigate whether the power of the effect size was based on adequate sample size in randomized controlled trials (RCTs) for the treatment of patients with type 2 diabetes mellitus (T2DM) using Chinese medicine. China Knowledge Resource Integrated Database (CNKI), VIP Database for Chinese Technical Periodicals (VIP), Chinese Biomedical Database (CBM), and Wangfang Data were systematically recruited using terms like "Xiaoke" or diabetes, Chinese herbal medicine, patent medicine, traditional Chinese medicine, randomized, controlled, blinded, and placebo-controlled. Limitation was set on the intervention course > or = 3 months in order to identify the information of outcome assessement and the sample size. Data collection forms were made according to the checking lists found in the CONSORT statement. Independent double data extractions were performed on all included trials. The statistical power of the effects size for each RCT study was assessed using sample size calculation equations. (1) A total of 207 RCTs were included, including 111 superiority trials and 96 non-inferiority trials. (2) Among the 111 superiority trials, fasting plasma glucose (FPG) and glycosylated hemoglobin HbA1c (HbA1c) outcome measure were reported in 9% and 12% of the RCTs respectively with the sample size > 150 in each trial. For the outcome of HbA1c, only 10% of the RCTs had more than 80% power. For FPG, 23% of the RCTs had more than 80% power. (3) In the 96 non-inferiority trials, the outcomes FPG and HbA1c were reported as 31% and 36% respectively. These RCTs had a samples size > 150. For HbA1c only 36% of the RCTs had more than 80% power. For FPG, only 27% of the studies had more than 80% power. The sample size for statistical analysis was distressingly low and most RCTs did not achieve 80% power. In order to obtain a sufficient statistic power, it is recommended that clinical trials should establish clear research objective and hypothesis first, and choose scientific and evidence

Successful private-public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines.

PubMed

Ruggieri, L; Giannuzzi, V; Baiardi, P; Bonifazi, F; Davies, E H; Giaquinto, C; Bonifazi, D; Felisi, M; Chiron, C; Pressler, R; Rabe, H; Whitaker, M J; Neubert, A; Jacqz-Aigrain, E; Eichler, I; Turner, M A; Ceci, A

2015-04-01

The European Paediatric Regulation mandated the European Commission to fund research on off-patent medicines with demonstrated therapeutic interest for children. Responding to this mandate, five FP7 project calls were launched and 20 projects were granted. This paper aims to detail the funded projects and their preliminary results. Publicly available sources have been consulted and a descriptive analysis has been performed. Twenty Research Consortia including 246 partners in 29 European and non-European countries were created (involving 129 universities or public-funded research organisations, 51 private companies with 40 SMEs, 7 patient associations). The funded projects investigate 24 medicines, covering 10 therapeutic areas in all paediatric age groups. In response to the Paediatric Regulation and to apply for a Paediatric Use Marketing Authorisation, 15 Paediatric Investigation Plans have been granted by the EMA-Paediatric Committee, including 71 studies of whom 29 paediatric clinical trials, leading to a total of 7,300 children to be recruited in more than 380 investigational centres. Notwithstanding the EU contribution for each study is lower than similar publicly funded projects, and also considering the complexity of paediatric research, these projects are performing high-quality research and are progressing towards the increase of new paediatric medicines on the market. Private-public partnerships have been effectively implemented, providing a good example for future collaborative actions. Since these projects cover a limited number of off-patent drugs and many unmet therapeutic needs in paediatrics remain, it is crucial foreseeing new similar initiatives in forthcoming European funding programmes.

Vented Launch Vehicle Adaptor for a Manned Spacecraft with "Pusher" Launch Abort System

NASA Technical Reports Server (NTRS)

Vandervort, Robert E. (Inventor)

2017-01-01

A system, method, and apparatus for a vented launch vehicle adaptor (LVA) for a manned spacecraft with a "pusher" launch abort system are disclosed. The disclosed LVA provides a structural interface between a commercial crew vehicle (CCV) crew module/service module (CM/SM) spacecraft and an expendable launch vehicle. The LVA provides structural attachment of the module to the launch vehicle. It also provides a means to control the exhaust plume from a pusher-type launch abort system that is integrated into the module. In case of an on-pad or ascent abort, which requires the module to jettison away from the launch vehicle, the launch abort system exhaust plume must be safely directed away from critical and dangerous portions of the launch vehicle in order to achieve a safe and successful jettison.

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.

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.

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.

Design of an airborne launch vehicle for an air launched space booster

NASA Technical Reports Server (NTRS)

Chao, Chin; Choi, Rich; Cohen, Scott; Dumont, Brian; Gibin, Mauricius; Jorden, Rob; Poth, Stefan

1993-01-01

A conceptual design is presented for a carrier vehicle for an air launched space booster. This airplane is capable of carrying a 500,000 pound satellite launch system to an altitude over 40,000 feet for launch. The airplane features a twin fuselage configuration for improved payload and landing gear integration, a high aspect ratio wing for maneuverability at altitude, and is powered by six General Electric GE-90 engines. The analysis methods used and the systems employed in the airplane are discussed. Launch costs are expected to be competitive with existing launch systems.

Design of an airborne launch vehicle for an air launched space booster

NASA Astrophysics Data System (ADS)

Chao, Chin; Choi, Rich; Cohen, Scott; Dumont, Brian; Gibin, Mauricius; Jorden, Rob; Poth, Stefan

1993-12-01

A conceptual design is presented for a carrier vehicle for an air launched space booster. This airplane is capable of carrying a 500,000 pound satellite launch system to an altitude over 40,000 feet for launch. The airplane features a twin fuselage configuration for improved payload and landing gear integration, a high aspect ratio wing for maneuverability at altitude, and is powered by six General Electric GE-90 engines. The analysis methods used and the systems employed in the airplane are discussed. Launch costs are expected to be competitive with existing launch systems.

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

NASA's Space Launch System: Momentum Builds Towards First Launch

NASA Technical Reports Server (NTRS)

May, Todd; Lyles, Garry

2014-01-01

NASA's Space Launch System (SLS) is gaining momentum programmatically and technically toward the first launch of a new exploration-class heavy lift launch vehicle for international exploration and science initiatives. The SLS comprises an architecture that begins with a vehicle capable of launching 70 metric tons (t) into low Earth orbit. Its first mission will be the launch of the Orion Multi-Purpose Crew Vehicle (MPCV) on its first autonomous flight beyond the Moon and back. SLS will also launch the first Orion crewed flight in 2021. SLS can evolve to a 130-t lift capability and serve as a baseline for numerous robotic and human missions ranging from a Mars sample return to delivering the first astronauts to explore another planet. Managed by NASA's Marshall Space Flight Center, the SLS Program formally transitioned from the formulation phase to implementation with the successful completion of the rigorous Key Decision Point C review in 2014. At KDP-C, the Agency Planning Management Council determines the readiness of a program to go to the next life-cycle phase and makes technical, cost, and schedule commitments to its external stakeholders. As a result, the Agency authorized the Program to move forward to Critical Design Review, scheduled for 2015, and a launch readiness date of November 2018. Every SLS element is currently in testing or test preparations. The Program shipped its first flight hardware in 2014 in preparation for Orion's Exploration Flight Test-1 (EFT-1) launch on a Delta IV Heavy rocket in December, a significant first step toward human journeys into deep space. Accomplishments during 2014 included manufacture of Core Stage test articles and preparations for qualification testing the Solid Rocket Boosters and the RS-25 Core Stage engines. SLS was conceived with the goals of safety, affordability, and sustainability, while also providing unprecedented capability for human exploration and scientific discovery beyond Earth orbit. In an environment

Systematic review on randomized controlled trials of coronary heart disease complicated with depression treated with Chinese herbal medicines.

PubMed

Wang, An-Lu; Chen, Zhuo; Luo, Jing; Shang, Qing-Hua; Xu, Hao

2016-01-01

This systemic review evaluated the efficacy and safety of Chinese herbal medicines (CHMs) in patients with coronary heart disease (CHD) complicated with depression. All databases were retrieved till September 30, 2014. Randomized controlled trials (RCTs) comparing CHMs with placebo or conventional Western medicine were retrieved. Data extraction, analyses and quality assessment were performed according to the Cochrane standards. RevMan 5.3 was used to synthesize the results. Thirteen RCTs enrolling 1,095 patients were included. Subgroup analysis was used to assess data. In reducing the degree of depression, CHMs showed no statistic difference in the 4th week [mean difference (MD)=-1.06; 95% confidence interval (CI)-2.38 to 0.26; n=501; I(2)=73%], but it was associated with a statistically significant difference in the 8th week (MD=-1.00; 95% CI-1.64 to-0.36; n=436; I(2)=48%). Meanwhile, the combination therapy (CHMs together with antidepressants) showed significant statistic differences both in the 4th week (MD=-1.99; 95% CI-3.80 to-0.18; n=90) and in the 8th week (MD=-5.61; 95% CI-6.26 to-4.97; n=242; I(2)=87%). In CHD-related clinical evaluation, 3 trials reported the intervention group was superior to the control group. Four trials showed adverse events in the intervention group was less than that in the control group. CHMs showed potentially benefits on patients with CHD complicated with depression. Moreover, the effect of CHMs may be similar to or better than antidepressant in certain fields but with less side effects. However, because of small sample size and potential bias of most trials, this result should be interpreted with caution. More rigorous trials with larger sample size and higher quality are warranted to give high quality of evidence to support the use of CHMs for CHD complicated with depression.

14 CFR 420.21 - Launch site location review-launch site boundary.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Launch site location review-launch site boundary. 420.21 Section 420.21 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION... the debris dispersion radius of the largest launch vehicle type and weight class proposed for the...

14 CFR 420.21 - Launch site location review-launch site boundary.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Launch site location review-launch site boundary. 420.21 Section 420.21 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION... the debris dispersion radius of the largest launch vehicle type and weight class proposed for the...

14 CFR 420.21 - Launch site location review-launch site boundary.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Launch site location review-launch site boundary. 420.21 Section 420.21 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION... the debris dispersion radius of the largest launch vehicle type and weight class proposed for the...

14 CFR 420.21 - Launch site location review-launch site boundary.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Launch site location review-launch site boundary. 420.21 Section 420.21 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION... the debris dispersion radius of the largest launch vehicle type and weight class proposed for the...

14 CFR 420.21 - Launch site location review-launch site boundary.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Launch site location review-launch site boundary. 420.21 Section 420.21 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION... the debris dispersion radius of the largest launch vehicle type and weight class proposed for the...

14 CFR 417.17 - Launch reporting requirements and launch specific updates.

Code of Federal Regulations, 2010 CFR

2010-01-01

... by the terms of the launch operator's license. A launch operator must file any change to the... information: (i) Payload information required by § 415.59 of this chapter; and (ii) Flight information, including the launch vehicle, planned flight path, staging and impact locations, and any on-orbit activity...

14 CFR 417.17 - Launch reporting requirements and launch specific updates.

Code of Federal Regulations, 2014 CFR

2014-01-01

... by the terms of the launch operator's license. A launch operator must file any change to the... information: (i) Payload information required by § 415.59 of this chapter; and (ii) Flight information, including the launch vehicle, planned flight path, staging and impact locations, and any on-orbit activity...

14 CFR 417.17 - Launch reporting requirements and launch specific updates.

Code of Federal Regulations, 2013 CFR

2013-01-01

... by the terms of the launch operator's license. A launch operator must file any change to the... information: (i) Payload information required by § 415.59 of this chapter; and (ii) Flight information, including the launch vehicle, planned flight path, staging and impact locations, and any on-orbit activity...

14 CFR 417.17 - Launch reporting requirements and launch specific updates.

Code of Federal Regulations, 2011 CFR

2011-01-01

... by the terms of the launch operator's license. A launch operator must file any change to the... information: (i) Payload information required by § 415.59 of this chapter; and (ii) Flight information, including the launch vehicle, planned flight path, staging and impact locations, and any on-orbit activity...

14 CFR 417.17 - Launch reporting requirements and launch specific updates.

Code of Federal Regulations, 2012 CFR

2012-01-01

... by the terms of the launch operator's license. A launch operator must file any change to the... information: (i) Payload information required by § 415.59 of this chapter; and (ii) Flight information, including the launch vehicle, planned flight path, staging and impact locations, and any on-orbit activity...

Internet-based randomised controlled trials for the evaluation of complementary and alternative medicines: probiotics in spondyloarthropathy

PubMed Central

Brophy, Sinead; Burrows, Claire L; Brooks, Caroline; Gravenor, Michael B; Siebert, Stefan; Allen, Stephen J

2008-01-01

Background The clinical effectiveness of complementary and alternative medicines (CAMs) is widely debated because of a lack of clinical trials. The internet may provide an effective and economical approach for undertaking randomised controlled trials (RCTs) of low-risk interventions. We investigated whether the internet could be used to perform an internet-based RCT of a CAM fulfilling the revised CONSORT (Consolidated Standards of Reporting Trials) statement quality checklist for reporting of RCTs. A secondary aim was to examine the effect of probiotics compared to placebo in terms of well-being over 12 weeks. Methods People aged ≥18 years with confirmed spondyloarthropathy living in the United Kingdom with internet access were invited to participate in an internet-based RCT of probiotic compared to placebo for improving well-being and bowel symptoms. The intervention was a probiotic containing 4 strains of live bacteria or identical placebo taken by mouth daily for 3 months. The primary outcome measure was the performance of the trial according to the revised CONSORT statement. Results 147 people were randomised into the trial. The internet-based trial of the CAM fulfilled the revised CONSORT statement such as efficient blinding, allocation concealment, intention to treat analysis and flow of participants through the trial. Recruitment of the required number of participants was completed in 19 months. Sixty-five percent (96/147) completed the entire 3 months of the trial. The trial was low cost and demonstrated that in an intention to treat analysis, probiotics did not improve well-being or bowel symptoms. Conclusion The internet-based RCT proved to be a successful and economical method for examining this CAM intervention. Recruitment, adherence and completion rate were all similar to those reported with conventional RCTs but at a fraction of the cost. Internet-based RCTs can fulfil all the criteria of the revised CONSORT statement and are an appropriate method

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)

Participant selection for preventive Regenerative Medicine trials: ethical challenges of selecting individuals at risk.

PubMed

Niemansburg, Sophie L; Habets, Michelle G J L; Dhert, Wouter J A; van Delden, Johannes J M; Bredenoord, Annelien L

2015-11-01

The innovative field of Regenerative Medicine (RM) is expected to extend the possibilities of prevention or early treatment in healthcare. Increasingly, clinical trials will be developed for people at risk of disease to investigate these RM interventions. These individuals at risk are characterised by their susceptibility for developing clinically manifest disease in future due to the existence of degenerative abnormalities. So far, there has been little debate about the ethical appropriateness of including such individuals at risk in clinical trials. We discuss three main challenges of selecting this participant model for testing RM interventions: the challenge of achieving a proportional risk-benefit balance; complexities in the trial design in terms of follow-up and sample size; and the difficulty of obtaining informed consent due to the many uncertainties. We conclude that selecting the model is not ethically justifiable for first-in-man trials with RM interventions due to the high risks and uncertainties. However, the model can be ethically appropriate for testing the efficacy of RM interventions under the following conditions: interventions should be low risk; the degenerative abnormalities (and other risk factors) should be strongly related with disease within a short time frame; robust preclinical evidence of efficacy needs to be present; and the informed consent procedure should contain extra safeguards with regard to communication on uncertainties. 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/

Integrative Medicine in Head and Neck Cancer.

PubMed

Matovina, Chloe; Birkeland, Andrew C; Zick, Suzanna; Shuman, Andrew G

2017-02-01

Objective Complementary and alternative medicine, or integrative medicine, has become increasingly popular among patients with head and neck cancer. Despite its increasing prevalence, many patients feel uncomfortable discussing such therapies with their physicians, and many physicians are unaware and underequipped to evaluate or discuss their use with patients. The aim of this article is to use recent data to outline the decision making inherent to integrative medicine utilization among patients with head and neck cancer, to discuss the ethical implications inherent to balancing integrative and conventional approaches to treatment, and to highlight available resources to enhance head and neck cancer providers' understanding of integrative medicine. Data Sources Randomized controlled trials involving integrative medicine or complementary and alternative medicine treatment for cancer patients. Review Methods Trials were drawn from a systematic PubMed database search categorized into cancer prevention, treatment, and symptom management. Conclusions Integrative medicine is gaining popularity for the management of cancer and is most commonly used for symptom management. A number of randomized controlled trials provide data to support integrative therapies, yet physicians who treat head and neck cancer may be faced with ethical dilemmas and practical barriers surrounding incorporation of integrative medicine. Implications for Practice In the management of head and neck cancer, there is an increasing demand for awareness of, dialogue about, and research evaluating integrative medicine therapies. It is important for otolaryngologists to become aware of integrative therapy options, their risks and benefits, and resources for further information to effectively counsel their patients.

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)

NCTN/NCORP Data Archive: Expanding Access to Clinical Trial Data

Cancer.gov

NCI is launching the NCTN/NCORP Data Archive, a centralized repository of patient-level data from phase III clinical trials conducted by NCI’s NCTN and NCORP trials programs and the National Cancer Institute of Canada-Clinical Trials Group.

14 CFR 1214.117 - Launch and orbit parameters for a standard launch.

Code of Federal Regulations, 2010 CFR

2010-01-01

...) Launch at a time, selected by NASA, from a launch window of not less than 1 hour (a more restrictive launch window may be provided as an optional service). (b) For shared flights from KSC to the standard...

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.

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.

PUPTH Prehospital Air Medical Plasma (PAMP) Trial

DTIC Science & Technology

2014-07-01

collection of information, including suggestions for reducing this burden to Department of Defense, Washington Headquarters Services, Directorate for...projects. Scott Gunn, MD, is an Associate Professor of CCM and Emergency Medicine and Director , Combined Emergency Medicine/Internal Medicine/CCM...Residency Program. Dr. Gunn is also Director of the CCM Clinical Trials Program. As such, he is experienced in the design and monitoring of clinical trials

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.

The European Medicines Agency's approval of new medicines for type 2 diabetes.

PubMed

Blind, Eberhard; Janssen, Heidi; Dunder, Kristina; de Graeff, Pieter A

2018-05-08

Since 2005, more than 40 new medicines for the treatment of type 2 diabetes have been introduced on the market. These consist of 15 new active substances establishing three new classes of non-insulin products, and several new or modified insulin products and combinations. The approval of these products in Europe is regulated via the centralized procedure at the European Medicines Agency. Demonstration of benefit with regard to improved glucose control remains the principal outcome required from confirmatory studies to demonstrate efficacy. For the majority of these new medicines approved since 2005, cardiovascular outcome trials have now been completed, and have invariably supported the cardiovascular safety of these products. In some of these trials additional important benefits have been observed, for instance, a reduction in major adverse cardiovascular events and improvement of renal outcome. The existing regulatory framework and the continuous adaption of regulatory requirements to emerging developments will continue to guide the approval of new products in the future. © 2018 John Wiley & Sons Ltd.

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

Toward precision medicine in Alzheimer's disease.

PubMed

Reitz, Christiane

2016-03-01

In Western societies, Alzheimer's disease (AD) is the most common form of dementia and the sixth leading cause of death. In recent years, the concept of precision medicine, an approach for disease prevention and treatment that is personalized to an individual's specific pattern of genetic variability, environment and lifestyle factors, has emerged. While for some diseases, in particular select cancers and a few monogenetic disorders such as cystic fibrosis, significant advances in precision medicine have been made over the past years, for most other diseases precision medicine is only in its beginning. To advance the application of precision medicine to a wider spectrum of disorders, governments around the world are starting to launch Precision Medicine Initiatives, major efforts to generate the extensive scientific knowledge needed to integrate the model of precision medicine into every day clinical practice. In this article we summarize the state of precision medicine in AD, review major obstacles in its development, and discuss its benefits in this highly prevalent, clinically and pathologically complex disease.

Integrative medicine in head and neck cancer

PubMed Central

Matovina, Chloe; Birkeland, Andrew C.; Zick, Suzanna; Shuman, Andrew G.

2017-01-01

Objective Complementary and alternative medicine (CAM), or integrative medicine, has become increasingly popular among patients with head and neck cancer. Despite its increasing prevalence, many patients feel uncomfortable discussing such therapies with their physicians, and many physicians are unaware and underequipped to evaluate or discuss their use with patients. The aim of this manuscript is to use recent data to outline the decision-making inherent to integrative medicine utilization among patients with head and neck cancer, to discuss the ethical implications inherent to balancing integrative and conventional approaches to treatment, and to highlight available resources to enhance head and neck cancer providers’ understanding of integrative medicine. Data Sources Randomized controlled trials involving integrative medicine or CAM treatment for cancer patients. Review Methods Trials were drawn from a systematic PubMed database search categorized into cancer prevention, treatment, and symptom management. Conclusions Integrative medicine is gaining popularity for the management of cancer and is most commonly used for symptom management. A number of randomized controlled trials provide data to support integrative therapies, yet physicians who treat head and neck cancer may be faced with ethical dilemmas and practical barriers surrounding incorporation of integrative medicine. Implications for Practice In the management of head and neck cancer, there is an increasing demand for awareness of, dialogue about, and research evaluating integrative medicine therapies. It is important for otolaryngologists to become aware of integrative therapy options, their risks and benefits, and resources for further information in order to effectively counsel their patients. PMID:27729559

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.

Authoritative knowledge, evidence-based medicine, and behavioral pediatrics.

PubMed

Kennell, J H

1999-12-01

Evidence-based medicine is the conscientious and judicious use of current best knowledge in making decisions about the care of individual patients, often from well-designed, randomized, controlled trials. Authoritative medicine is the traditional approach to learning and practicing medicine, but no one authority has comprehensive scientific knowledge. Archie Cochrane proposed that every medical specialty should compile a list of all of the randomized, controlled trials within its field to be available for those who wish to know what treatments are effective. This was done first for obstetrics by a group collecting and critically analyzing all of the randomized trials and then indicating procedures every mother should have and those that no mother should have. Support during labor was used as an example. Similar groups are now active in almost all specialties, with information available on the Internet in the Cochrane Database of Systematic Reviews. Developmental-behavioral pediatrics should be part of this movement to evidence-based medicine.

Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine.

PubMed

Wang, Ling; Li, Yulin; Li, Jing; Zhang, Mingming; Xu, Lin; Yuan, Wenming; Wang, Gang; Hopewell, Sally

2010-07-08

Due to language limitations, the abstract of journal article may be the only way for people of non-Chinese speaking countries to know about trials in traditional Chinese medicine (TCM). However, little is known about the reporting quality of these trial abstracts. Our study is to assess the reporting quality of abstracts of randomized controlled trials (RCT) published in four leading Chinese medical journals of TCM, and to identify any differences in reporting between the Chinese and English version of the same abstract publication. Two reviewers hand-searched the Chinese Journal of Integrated Traditional and Western Medicine, the Chinese Journal of Integrative Medicine, the China Journal of Chinese Materia Medica and the Chinese Acupuncture & Moxibustion for all abstracts of RCTs published between 2006 and 2007. Two reviewers independently assessed the reporting quality of the Chinese and English version of all eligible abstracts based on a modified version of the CONSORT for reporting randomised trials in journal and conference abstracts (CONSORT for abstracts). We identified a total of 345 RCTs of TCM with both a Chinese and English abstract. More than half of Chinese abstracts reported details of the trial participants (68%; 234/345), control group intervention (52%; 179/345), the number of participants randomized (73%; 253/345) and benefits when interpreting the trial results (55%; 190/345). Reporting of methodological quality or key features of trial design and trial results were poor; only 2% (7/345) included details of the trial design, 3% (11/345) defined the primary outcome, 5% (17/345) described the methods of random sequence generation, and only 4% (13/345) reported the number of participants analyzed. No abstracts provided details on allocation concealment and trial registration. The percentage agreement in reporting (between the Chinese and English version of the same abstract) ranged from 84% to 100% across individual checklist item. The reporting

Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine

PubMed Central

2010-01-01

Background Due to language limitations, the abstract of journal article may be the only way for people of non-Chinese speaking countries to know about trials in traditional Chinese medicine (TCM). However, little is known about the reporting quality of these trial abstracts. Our study is to assess the reporting quality of abstracts of randomized controlled trials (RCT) published in four leading Chinese medical journals of TCM, and to identify any differences in reporting between the Chinese and English version of the same abstract publication. Method Two reviewers hand-searched the Chinese Journal of Integrated Traditional and Western Medicine, the Chinese Journal of Integrative Medicine, the China Journal of Chinese Materia Medica and the Chinese Acupuncture & Moxibustion for all abstracts of RCTs published between 2006 and 2007. Two reviewers independently assessed the reporting quality of the Chinese and English version of all eligible abstracts based on a modified version of the CONSORT for reporting randomised trials in journal and conference abstracts (CONSORT for abstracts). Results We identified a total of 345 RCTs of TCM with both a Chinese and English abstract. More than half of Chinese abstracts reported details of the trial participants (68%; 234/345), control group intervention (52%; 179/345), the number of participants randomized (73%; 253/345) and benefits when interpreting the trial results (55%; 190/345). Reporting of methodological quality or key features of trial design and trial results were poor; only 2% (7/345) included details of the trial design, 3% (11/345) defined the primary outcome, 5% (17/345) described the methods of random sequence generation, and only 4% (13/345) reported the number of participants analyzed. No abstracts provided details on allocation concealment and trial registration. The percentage agreement in reporting (between the Chinese and English version of the same abstract) ranged from 84% to 100% across individual

Traditional Chinese Medicine herbs for stopping bleeding from haemorrhoids.

PubMed

Gan, Tao; Liu, Yue-Dong; Wang, Yiping; Yang, Jinlin

2010-10-06

Haemorrhoids is a common perianal disease, which often causes haematochezia. Besides a surgical operation or minimally invasive treatment, a variety of traditional Chinese medicinal herbs (TCMHs) have been used to treat bleeding haemorrhoids. To assess the effectiveness of traditional Chinese medicinal herbs for stopping bleeding from haemorrhoids and the adverse effects caused by these herbs. We searched the Cochrane Colorectal Cancer Group Trials Register, Cochrane Central Register of Contolled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, CMCD (Chinese Medicine Conference Disc) and CBMD (Chinese Bio-Medicine Disc). All randomised clinical trials (RCTs) of Chinese herbs for bleeding haemorrhoids were included. Two authors independently extracted the data, which were analysed using RevMan 5.0 software. We estimated the relative risk for dichotomous data and calculated the weighted mean difference for continuous data. Nine trials involving 1822 patients with bleeding haemorrhoids were identified. The included trials were generally not of high quality and used one TCMH preparation compared with another TCMH preparation (Type I) (five trials) or western medicines (Type II) (four trials). We could not pool the data to perform a meta-analysis as only two of the included trials used the same intervention or comparison.In the nine trials, TCMHs showed a statistically significant difference for the improvement in the general curative effects or total grade of symptoms in six trials (P < 0.05; P < 0.01), of hematochezia in three trials (P < 0.05; P < 0.001), and of inflammation of perianal mucosa in one trial (P < 0.05). The adverse effects reported were not serious and were scarce. This review did not provide strong evidence concerning the effectiveness of TCMHs for stopping bleeding from haemorrhoids. Most of the included studies were of low quality and there was a scarcity of eligible trials and numbers of participants. Limited, weak evidence showed that

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)

Sustainable development of a GCP-compliant clinical trials platform in Africa: the malaria clinical trials alliance perspective.

PubMed

Ogutu, Bernhards R; Baiden, Rita; Diallo, Diadier; Smith, Peter G; Binka, Fred N

2010-04-20

The Malaria Clinical Trials Alliance (MCTA), a programme of INDEPTH network of demographic surveillance centres, was launched in 2006 with two broad objectives: to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of good clinical practice (GCP); and to support, strengthen and mentor the centres in the network to facilitate their progression towards self-sustaining clinical research centres. Sixteen research centres in 10 African malaria-endemic countries were selected that were already working with the Malaria Vaccine Initiative (MVI) or the Medicines for Malaria Venture (MMV). All centres were visited to assess their requirements for research capacity development through infrastructure strengthening and training. Support provided by MCTA included: laboratory and facility refurbishment; workshops on GCP, malaria diagnosis, strategic management and media training; and training to support staff to undertake accreditation examinations of the Association of Clinical Research Professionals (ACRP). Short attachments to other network centres were also supported to facilitate sharing practices within the Alliance. MCTA also played a key role in the creation of the African Media & Malaria Research Network (AMMREN), which aims to promote interaction between researchers and the media for appropriate publicity and media reporting of research and developments on malaria, including drug and vaccine trials. In three years, MCTA strengthened 13 centres to perform GCP-compliant drug and vaccine trials, including 11 centres that form the backbone of a large phase III malaria vaccine trial. MCTA activities have demonstrated that centres can be brought up to GCP compliance on this time scale, but the costs are substantial and there is a need for further support of other centres to meet the growing demand for clinical trial capacity. The MCTA experience also indicates that

Sustainable development of a GCP-compliant clinical trials platform in Africa: the Malaria Clinical Trials Alliance perspective

PubMed Central

2010-01-01

Background The Malaria Clinical Trials Alliance (MCTA), a programme of INDEPTH network of demographic surveillance centres, was launched in 2006 with two broad objectives: to facilitate the timely development of a network of centres in Africa with the capacity to conduct clinical trials of malaria vaccines and drugs under conditions of good clinical practice (GCP); and to support, strengthen and mentor the centres in the network to facilitate their progression towards self-sustaining clinical research centres. Case description Sixteen research centres in 10 African malaria-endemic countries were selected that were already working with the Malaria Vaccine Initiative (MVI) or the Medicines for Malaria Venture (MMV). All centres were visited to assess their requirements for research capacity development through infrastructure strengthening and training. Support provided by MCTA included: laboratory and facility refurbishment; workshops on GCP, malaria diagnosis, strategic management and media training; and training to support staff to undertake accreditation examinations of the Association of Clinical Research Professionals (ACRP). Short attachments to other network centres were also supported to facilitate sharing practices within the Alliance. MCTA also played a key role in the creation of the African Media & Malaria Research Network (AMMREN), which aims to promote interaction between researchers and the media for appropriate publicity and media reporting of research and developments on malaria, including drug and vaccine trials. Conclusion In three years, MCTA strengthened 13 centres to perform GCP-compliant drug and vaccine trials, including 11 centres that form the backbone of a large phase III malaria vaccine trial. MCTA activities have demonstrated that centres can be brought up to GCP compliance on this time scale, but the costs are substantial and there is a need for further support of other centres to meet the growing demand for clinical trial capacity. The

[Assessment of the results of syndrome in clinical trials of dementia treated by Chinese herbal medicine].

PubMed

Ni, Jing-nian; Shi, Jing; Tian, Jin-zhou; Liu, Bing-lin; Liu, Jian-ping; Liu, Tong-hua; Xu, Shi-qian; Cui, Gong-ping; Wang, Yong-yan

2013-03-01

Chinese medical syndrome efficacy, as a second efficacy indicator, has been widely used in clinical trials of treating dementia by Chinese herbal medicine. The syndrome assessment tool is a key point in assessing the efficacy of Chinese medical syndrome. The syndrome assessment tool for dementia used nowadays needs to be optimized in content, reliability, and validity. In this paper, the authors reviewed some problems correlated with the design of Chinese medical assessment questionnaire on the basis of Chinese medical theories by combining the common requirements for questionnaire development.

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

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 (η p 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.

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

14 CFR 1214.117 - Launch and orbit parameters for a standard launch.

Code of Federal Regulations, 2013 CFR

2013-01-01

...) Launch from Kennedy Space Center (KSC) into the customer's choice of two standard mission orbits: 160 NM... 14 Aeronautics and Space 5 2013-01-01 2013-01-01 false Launch and orbit parameters for a standard launch. 1214.117 Section 1214.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION...

14 CFR 1214.117 - Launch and orbit parameters for a standard launch.

Code of Federal Regulations, 2012 CFR

2012-01-01

...) Launch from Kennedy Space Center (KSC) into the customer's choice of two standard mission orbits: 160 NM... 14 Aeronautics and Space 5 2012-01-01 2012-01-01 false Launch and orbit parameters for a standard launch. 1214.117 Section 1214.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION...

14 CFR 1214.117 - Launch and orbit parameters for a standard launch.

Code of Federal Regulations, 2011 CFR

2011-01-01

...) Launch from Kennedy Space Center (KSC) into the customer's choice of two standard mission orbits: 160 NM... 14 Aeronautics and Space 5 2011-01-01 2010-01-01 true Launch and orbit parameters for a standard launch. 1214.117 Section 1214.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE ADMINISTRATION...

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.

Foreign launch competition growing

NASA Astrophysics Data System (ADS)

Brodsky, R. F.; Wolfe, M. G.; Pryke, I. W.

1986-07-01

A survey is given of progress made by other nations in providing or preparing to provide satellite launch services. The European Space Agency has four generations of Ariane vehicles, with a fifth recently approved; a second launch facility in French Guiana that has become operational has raised the possible Ariane launch rate to 10 per year, although a May failure of an Ariane 2 put launches on hold. The French Hermes spaceplane and the British HOTOL are discussed. Under the auspices of the Italian National Space Plane, the Iris orbital transfer vehicle is developed and China's Long March vehicles and the Soviet Protons and SL-4 vehicles are discussed; the Soviets moreover are apparently developing not only a Saturn V-class heavy lift vehicle with a 150,000-kg capacity (about five times the largest U.S. capacity) but also a space shuttle and a spaceplane. Four Japanese launch vehicles and some vehicles in an Indian program are also ready to provide launch services. In this new, tough market for launch services, the customers barely outnumber the suppliers. The competition develops just as the Challenger and Titan disasters place the U.S. at a disadvantage and underline the hard work ahead to recoup its heretofore leading position in launch services.

Side Effects of HIV Medicines: HIV and Lactic Acidosis

MedlinePlus

... Drugs Clinical Trials Apps skip to content Side Effects of HIV Medicines Home Understanding HIV/AIDS Fact ... and Immunizations What is a Drug Interaction? Side Effects of HIV Medicines HIV Medicines and Side Effects ...

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.

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)

Pegasus air-launched space booster

NASA Astrophysics Data System (ADS)

Lindberg, Robert E.; Mosier, Marty R.

The launching of small satellites with the mother- aircraft-launched Pegasus booster yields substantial cost improvements over ground launching and enhances operational flexibility, since it allows launches to be conducted into any orbital inclination. The Pegasus launch vehicle is a three-stage solid-rocket-propelled system with delta-winged first stage. The major components of airborne support equipment, located on the mother aircraft, encompass a launch panel operator console, an electronic pallet, and a pylon adapter. Alternatives to the currently employed B-52 launch platform aircraft have been identified for future use. Attention is given to the dynamic, thermal, and acoustic environments experienced by the payload.

Precision Medicine in Gastrointestinal Pathology.

PubMed

Wang, David H; Park, Jason Y

2016-05-01

-Precision medicine is the promise of individualized therapy and management of patients based on their personal biology. There are now multiple global initiatives to perform whole-genome sequencing on millions of individuals. In the United States, an early program was the Million Veteran Program, and a more recent proposal in 2015 by the president of the United States is the Precision Medicine Initiative. To implement precision medicine in routine oncology care, genetic variants present in tumors need to be matched with effective clinical therapeutics. When we focus on the current state of precision medicine for gastrointestinal malignancies, it becomes apparent that there is a mixed history of success and failure. -To present the current state of precision medicine using gastrointestinal oncology as a model. We will present currently available targeted therapeutics, promising new findings in clinical genomic oncology, remaining quality issues in genomic testing, and emerging oncology clinical trial designs. -Review of the literature including clinical genomic studies on gastrointestinal malignancies, clinical oncology trials on therapeutics targeted to molecular alterations, and emerging clinical oncology study designs. -Translating our ability to sequence thousands of genes into meaningful improvements in patient survival will be the challenge for the next decade.

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

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

PubMed

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

2002-04-01

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.

Informed Consent (Clinical Trials)

MedlinePlus

... Cancer Treatment Types of Cancer Treatment Side Effects Clinical Trials Information A to Z List of Cancer ... Staging Prognosis Treatment Types of Treatment Side Effects Clinical Trials Cancer Drugs Complementary & Alternative Medicine Coping Feelings & ...

Proposal of New Triggered Lightning Launch Commit Criteria for Japan's Safety Rocket Launch

NASA Astrophysics Data System (ADS)

Saito, Yasuhiro; Saito, Toshiya; Okita, Koichi

2013-09-01

Triggered lightning for rocket launch can cause the failure.The current Japanese criteria to postpone the launch opportunity is the thickness of cloud 1.8km with 0 -20 degrees Celsius. Of all H2A launches during these ten years, slipping launches have occurred over half of its flights. So, we have initiated a research on Triggered Lightning Launch Commit Criteria, two years ago.We present the overall activities with the observation campaign (RAIJIN*) in Feb/2012 and Jan-Feb/2013, by means of air-born field mill with airplane, X-band dual polarization radar, ground based field mill and Videosonde. Also, the analytical results and proposal of the new criteria will be shown.*) Raijin is originally a name for Thunder god in Japanese and here it stands for Rocket launch Atmospheric electricity Investigation by Jaxa IN cooperation with academia.

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

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.

Investigation into the Individualized Treatment of Traditional Chinese Medicine through a Series of N-of-1 Trials

PubMed Central

Yang, Peilan; Wang, Jie; Wu, Yingen; Zi, Suna; Tang, Jie; Wang, Zhenwei

2018-01-01

Purpose To compare the efficacy of individualized herbal decoction with standard decoction for patients with stable bronchiectasis through N-of-1 trials. Methods We conducted a single center N-of-1 trials in 17 patients with stable bronchiectasis. Each N-of-1 trial contains three cycles. Each cycle is divided into two 4-week intervention including individualized decoction and fixed decoction (control). The primary outcome was patient self-reported symptoms scores on a 1–7 point Likert scale. Secondary outcomes were 24-hour sputum volume and CAT scores. Results Among 14 completed trials, five showed that the individualized decoction was statistically better than the control decoction on symptom scores (P < 0.05) but was not clinically significant. The group data of all the trials showed that individualized decoction was superior to control decoction on symptom scores (2.13 ± 0.58 versus 2.30 ± 0.65, P = 0.002, mean difference and 95% CI: 0.18 (0.10, 0.25)), 24 h sputum volume (P = 0.009), and CAT scores (9.69 ± 4.89 versus 11.64 ± 5.59, P = 0.013, mean difference and 95% CI: 1.95 (1.04, 2.86)) but not clinically significant. Conclusion Optimizing the combined analysis of individual and group data and the improvement of statistical models may make contribution in establishing a method of evaluating clinical efficacy in line with the characteristics of traditional Chinese medicine individual diagnosis and treatment. PMID:29552084

SKYLAB IV - LAUNCH

NASA Image and Video Library

1973-11-27

S73-37285 (16 Nov. 1973) --- The Skylab 4/Saturn 1B space vehicle is launched from Pad B, Launch Complex 39, Kennedy Space Center, Florida, at 9:01:23 a.m. (EST), Friday, Nov. 16, 1973. Skylab 4 is the third and last of three scheduled manned Skylab missions. Aboard the Skylab 4 Command/Service Module were astronauts Gerald P. Carr, Edward G. Gibson and William R. Pogue. In addition to the CSM and its launch escape system, the Skylab 4 space vehicle consisted of the Saturn 1B first (S-1B) stage and the Saturn 1B second (S-IVB) stage. (The Skylab 1/Saturn V unmanned space vehicle with the space station payload was launched from Pad A on May 14, 1973). Photo credit: NASA

SKYLAB IV - LAUNCH

NASA Image and Video Library

1973-11-27

S73-37286 (16 Nov. 1973) --- The Skylab 4/Saturn 1B space vehicle is launched from Pad B, Launch Complex 39, Kennedy Space Center, Florida, at 9:01:23 a.m. (EST), Friday, Nov. 16, 1973. Skylab 4 is the third and last of three scheduled manned Skylab missions. Aboard the Skylab 4 Command/Service Module were astronauts Gerald P. Carr, Edward G. Gibson and William R. Pogue. In addition to the CSM and its launch escape system, the Skylab 4 space vehicle consisted of the Saturn 1B first (S-1B) stage and the Saturn 1B second (S-IVB) stage. (The Skylab 1/Saturn V unmanned space vehicle with the space station payload was launched from Pad A on May 14, 1973). Photo credit: NASA

Alternative and Integrative Medicine

MedlinePlus

... Proton Therapy Alternative & Integrative Medicine Clinical Trials GBM AGILE TTFields – Optune™ Brain Tumor Treatment Locations Treatment Side Effects & their Management Support and Resources Caregiver Resource Center Pediatric Caregiver ...

Magnetic Launch Assist System Demonstration

NASA Technical Reports Server (NTRS)

1999-01-01

This Quick Time movie demonstrates the Magnetic Launch Assist system, previously referred to as the Magnetic Levitation (Maglev) system, for space launch using a 5 foot model of a reusable Bantam Class launch vehicle on a 50 foot track that provided 6-g acceleration and 6-g de-acceleration. Overcoming the grip of Earth's gravity is a supreme challenge for engineers who design rockets that leave the planet. Engineers at the Marshall Space Flight Center have developed and tested Magnetic Launch Assist technologies that could levitate and accelerate a launch vehicle along a track at high speeds before it leaves the ground. Using electricity and magnetic fields, a Magnetic Launch Assist system would drive a spacecraft along a horizontal track until it reaches desired speeds. A full-scale, operational track would be about 1.5-miles long and capable of accelerating a vehicle to 600 mph in 9.5 seconds. The major advantages of launch assist for NASA launch vehicles is that it reduces the weight of the takeoff, the landing gear, the wing size, and less propellant resulting in significant cost savings. The US Navy and the British MOD (Ministry of Defense) are planning to use magnetic launch assist for their next generation aircraft carriers as the aircraft launch system. The US Army is considering using this technology for launching target drones for anti-aircraft training.

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

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

Cao, Huijuan; Wu, Ruohan; Han, Mei; Caldwell, Patrina Ha Yuen; Liu, Jian-Ping

2017-01-01

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. To systematically assess the safety and effectiveness of oral Chinese herbal medicine (CHM) for preventing HDN due to ABO incompatibility. 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. 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. 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.

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.

Implementation of the NCI’s National Clinical Trials Network

Cancer.gov

NCI is launching a new clinical trials research network intended to improve treatment for the more than 1.6 million Americans diagnosed with cancer each year. The new system, NCI’s National Clinical Trials Network (NCTN), will facilitate the rapid initia

APOLLO VIII - LAUNCH - KSC

NASA Image and Video Library

1968-12-21

S68-56002 (21 Dec. 1968) --- The Apollo 8 (Spacecraft 103/Saturn 503) space vehicle is launched from Pad A, Launch Complex 39, Kennedy Space Center (KSC), at 7:51 a.m. (EST), Dec. 21, 1968. The crew of the Apollo 8 lunar orbit mission is astronauts Frank Borman, commander; James A. Lovell Jr., command module pilot; and William A. Anders, lunar module pilot. Apollo 8 was the first manned Saturn V launch. (F-ls 1/3 way from top of mobile launch tower.)

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. Copyright © 2015 Elsevier Inc. All rights reserved.

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.

STS-111/Endeavour/ISS UF2 Pre-Launch Activities: Launch with Playbacks

NASA Technical Reports Server (NTRS)

2002-01-01

This video of the preflight preparations for and launch of Space Shuttle Endeavour on STS-111 begins with a view of Endeavour on the launch pad. Additional launch pad views leading up to liftoff are interspersed with footage from the Firing Room at Kennedy Space Center, the crew's prelaunch activities, and inspection of the crew members in the White Room before boarding Endeavour. The crew is introduced by a narrator during the preflight banquet and suiting up, and a later clip shows them departing to the launch site. The crew consists of Commander Kenneth Cockrell, Pilot Paul Lockhart, Mission Specialists Philippe Perrin and Franklin Chang-Diaz, and the Expedition 5 crew of the International Space Station (ISS) (Commander Valery Korzun and Flight Engineers Peggy Whitsun and Sergei Treschev). The nozzles on Endeavour's Space Shuttle Main Engine (SSME) are swiveled before liftoff, and the launch is shown past the separation of the solid rocket boosters. After a brief clip from the Mission Control Center at Johnson Space Center, the following launch replays are shown: Beach Tracker, VAB, Pad A, Tower 1, UCS-15, Grandstand, Cocoa Beach DOAMS, Playalinda DOAMS, UCS-23, and OTV-070.

Preparing emergency physicians for malpractice litigation: a joint emergency medicine residency-law school mock trial competition.

PubMed

Drukteinis, Dainius A; O'Keefe, Kelly; Sanson, Tracy; Orban, David

2014-01-01

Fear of malpractice affects the daily life of many emergency physicians. Educational programs to prepare for litigation are lacking. An educational collaboration between an emergency medicine residency and a law school, whereby a medical malpractice mock trial competition is used to teach residents basic skills for testifying in legal proceedings. Ten residents in an academic emergency medicine program volunteered as witnesses in a malpractice mock trial competition at a law school. Residents testified two or three times and, after each appearance, were provided feedback to prepare them for subsequent rounds of testimony. They were also given access to videotaped testimony. Judges rated each resident using a nine-question survey scored on a 10-point Likert scale. Scores were compared as a group between rounds of testimony. Participants demonstrated significant improvement in seven of nine measured categories. p-Values reached significance in: Worked Well on Direct Examination (p < 0.001), Demeanor/Body Language (p < 0.001), Was Not Arrogant/Did Not Lose Poise on Cross-Examination (p = 0.001), Convincing Witness (p = 0.001), Appeared Knowledgeable (p = 0.012), Courtroom Attire (p = 0.012), and Expressed Themselves Clearly (p = 0.017). In addition, residents anonymously reported broad educational benefit. This novel educational collaboration taught residents about the process of litigation. It improved their communication skills and expanded their knowledge of documentation pitfalls, problems with staff interaction, and consequences of medical errors. This mutually beneficial partnership between a medical residency and a law school solidified it as a permanent feature of the residency program. Copyright © 2014 Elsevier Inc. All rights reserved.

Evolution of the Florida Launch Site Architecture: Embracing Multiple Customers, Enhancing Launch Opportunities

NASA Technical Reports Server (NTRS)

Colloredo, Scott; Gray, James A.

2011-01-01

The impending conclusion of the Space Shuttle Program and the Constellation Program cancellation unveiled in the FY2011 President's budget created a large void for human spaceflight capability and specifically launch activity from the Florida launch Site (FlS). This void created an opportunity to re-architect the launch site to be more accommodating to the future NASA heavy lift and commercial space industry. The goal is to evolve the heritage capabilities into a more affordable and flexible launch complex. This case study will discuss the FlS architecture evolution from the trade studies to select primary launch site locations for future customers, to improving infrastructure; promoting environmental remediation/compliance; improving offline processing, manufacturing, & recovery; developing range interface and control services with the US Air Force, and developing modernization efforts for the launch Pad, Vehicle Assembly Building, Mobile launcher, and supporting infrastructure. The architecture studies will steer how to best invest limited modernization funding from initiatives like the 21 st elSe and other potential funding.

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

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.

Space Shuttle Discovery Launch

NASA Image and Video Library

2008-05-31

NASA Administrator, Michael Griffin watches the launch of the Space Shuttle Discovery (STS-124) from the Launch Control Center 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)

NASA's Space Launch System: Momentum Builds Toward First Launch

NASA Technical Reports Server (NTRS)

May, Todd A.; Lyles, Garry M.

2014-01-01

NASA's Space Launch System (SLS) is gaining momentum toward the first launch of a new exploration-class heavy lift launch vehicle for international exploration and science initiatives. The SLS comprises an architecture that begins with a vehicle capable of launching 70 metric tons (t) into low Earth orbit. It will launch the Orion Multi-Purpose Crew Vehicle (MPCV) on its first autonomous flight beyond the Moon and back in December 2017. Its first crewed flight follows in 2021. SLS can evolve to a130-t lift capability and serve as a baseline for numerous robotic and human missions ranging from a Mars sample return to delivering the first astronauts to explore another planet. The SLS Program formally transitioned from the formulation phase to implementation with the successful completion of the rigorous Key Decision Point C review in 2014. As a result, the Agency authorized the Program to move forward to Critical Design Review, scheduled for 2015. In the NASA project life cycle process, SLS has completed 50 percent of its major milestones toward first flight. Every SLS element manufactured development hardware for testing over the past year. Accomplishments during 2013/2014 included manufacture of core stage test articles, preparations for qualification testing the solid rocket boosters and the RS-25 main engines, and shipment of the first flight hardware in preparation for the Exploration Flight Test-1 (EFT-1) in 2014. SLS was conceived with the goals of safety, affordability, and sustainability, while also providing unprecedented capability for human exploration and scientific discovery beyond Earth orbit. In an environment of economic challenges, the SLS team continues to meet ambitious budget and schedule targets through the studied use of hardware, infrastructure, and workforce investments the United States made in the last half century, while selectively using new technologies for design, manufacturing, and testing, as well as streamlined management approaches

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

KSC Vertical Launch Site Evaluation

NASA Technical Reports Server (NTRS)

Phillips, Lynne V.

2007-01-01

RS&H was tasked to evaluate the potential available launch sites for a combined two user launch pad. The Launch sites were to be contained entirely within current Kennedy Space Center property lines. The user launch vehicles to be used for evaluation are in the one million pounds of first stage thrust range. Additionally a second evaluation criterion was added early on in the study. A single user launch site was to be evaluated for a two million pound first stage thrust vehicle. Both scenarios were to be included in the report. To provide fidelity to the study criteria, a specific launch vehicle in the one million pound thrust range was chosen as a guide post or straw-man launch vehicle. The RpK K-1 vehicle is a current Commercial Orbital Transportation System (COTS), contract awardee along with the SpaceX Falcon 9 vehicle. SpaceX, at the time of writing, is planning to launch COTS and possibly other payloads from Cx-40 on Cape Canaveral Air Force Station property. RpK has yet to declare a specific launch site as their east coast US launch location. As such it was deemed appropriate that RpK's vehicle requirements be used as conceptual criteria. For the purposes of this study those criteria were marginally generalized to make them less specifiC.

Chinese medicine for treatment of chronic hepatitis B.

PubMed

Wang, Guqi; Zhang, Lingyi; Bonkovsky, Herbert L

2012-04-01

Contemporary Western medicines approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis B (CHB), although available in China, have high costs, or major side effects and limited effectiveness. Research efforts have focused on looking for natural products as alternative medicines with low cost and good safety for CHB treatment. Chinese medicine (CM) has ancient, time-honored theories about methods of diagnosis and treatment for liver diseases. In recent decades, a large number of clinical trials and pre-clinical studies, which were performed in China and other countries, indicated that CM has potential benefit in several aspects of the treatment of CHB, e.g., anti-inflammatory, anticancer, antioxidant, immunomodulating, antifibrosis, and antiviral. However, there are many concerns regarding the study design and the quality of clinical trials. Further larger, stringently designed, double-blind, placebo control, randomized clinical trials and long-term follow-up are needed to provide conclusive evidence of their efficacy and safety. Components of CM deserve further study in pre-clinical models of HBV infection and in clinical trials world-wide.

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

Nutrition Intervention Trials in Linxian, China

Cancer.gov

Randomized controlled trials were launched in 1985 to test the effects of multiple vitamin and mineral interventions on total mortality and total and cause-specific cancer mortality in a rural Chinese population

Treatment of asthma patients with herbal medicine TJ-96: a randomized controlled trial.

PubMed

Urata, Y; Yoshida, S; Irie, Y; Tanigawa, T; Amayasu, H; Nakabayashi, M; Akahori, K

2002-06-01

Alternative medicine use has increased at a remarkable pace all over the world in recent years. Although herbal medicine for the treatment of asthma is becoming the focus of public attention, randomized studies had not been performed, even in Eastern countries including Japan. This study was designed to investigate whether one of the Japanese government approved herbal complexes Saiboku-to (TJ-96) is effective for the treatment of atopic asthma, and to investigate whether this protective activity is associated with a reduction in eosinophilic inflammation. A double-blind, randomized, crossover design was used. Subjects received 2.5 g of TJ-96 or placebo orally 3 times daily for 4 weeks and then, after a washout period of at least 4 weeks, crossed over to receive the alternative treatment. We assessed the effects of pretreatment with TJ-96 on bronchoconstriction precipitated by inhalation of methacholine. Furthermore, eosinophil counts and measurement of eosinophilic cationic protein (ECP) were performed. After 4 weeks of treatment with TJ-96, values of PC20 -methacholine significantly improved in the treatment with TJ-96. Also, patients' symptoms, blood eosinophils, serum ECP, sputum eosinophils, and sputum ECP were significantly decreased. Our results suggest that TJ-96 has an antiinflammatory effect on bronchial eosinophilic infiltration. This study raises further interesting therapeutic possibilities and argues for further trials of new approaches to the treatment of asthma.

Complementary and Alternative Medicine Treatments for Generalized Anxiety Disorder: Systematic Review and Meta-analysis of Randomized Controlled Trials.

PubMed

Barić, Hrvoje; Đorđević, Veljko; Cerovečki, Ivan; Trkulja, Vladimir

2018-03-01

The objective was to evaluate efficacy/safety of complementary and alternative medicine (CAM) methods for generalized anxiety disorder (GAD) based on randomized controlled trials in adults. Data sources. Six electronic databases ("generalized anxiety (disorder)" and "randomized trial") and reference lists of identified publications were searched to March 2017. Eligibility: full-text publications (English, German language); CAM versus conventional treatment, placebo/sham or no treatment; GAD diagnosed according to standard criteria; and a validated scale for disease severity. Of the 6693 screened records, 32 were included (18 on biologically-based therapies, exclusively herbal preparations; eight on manipulative and body-based therapies; and three on alternative medical systems and three on mind-body therapies). Cochrane Collaboration methodology was used for quality assessment and data extraction. Direct comparisons of Kava Kava (Piper methysticum) extracts to placebo (4 quality trials, n = 233) were highly heterogeneous. Network meta-regression reduced heterogeneity and suggested a modest Kava effect [end-of-treatment Hamilton Anxiety scale score difference adjusted for baseline scores and trial duration: - 3.24 (95% CI - 6.65, 0.17; P = 0.059), Kava Kava 4 arms, n = 139; placebo 5 arms, n = 359]. Lavender (Lavandula angustifolia) extract (1 quality trial, 10 weeks, n = 523) and a combination of extracts of C. oxycantha, E. californica and magnesium (1 quality trial, 12 weeks, n = 264) were superior to placebo and balneotherapy was superior to paroxetine (1 quality trial, 8 weeks, n = 237) indicating efficacy. All other trials were small and/or of modest/low quality and/or lacked assay sensitivity. Safety reporting was poor. Evidence about efficacy/safety of most CAM methods in GAD is limited. Apparent efficacy of certain herbal preparations and body-based therapies requires further confirmation.

14 CFR § 1214.117 - Launch and orbit parameters for a standard launch.

Code of Federal Regulations, 2014 CFR

2014-01-01

... flights: (1) Launch from Kennedy Space Center (KSC) into the customer's choice of two standard mission... 14 Aeronautics and Space 5 2014-01-01 2014-01-01 false Launch and orbit parameters for a standard launch. § 1214.117 Section § 1214.117 Aeronautics and Space NATIONAL AERONAUTICS AND SPACE...

ARES I-X Launch

NASA Image and Video Library

2009-10-27

NASA Ares I-X Launch Director Ed Mango, left, laughs as NASA Ares I-X Assistant Launch Director Pete Nickolenko looks out the window of Firing Room One of the Launch Control Center (LCC) at the Kennedy Space Center prior to the launch of the Ares I-X rocket from pad 39b at the Kennedy Space Center in Cape Canaveral, Fla., Wednesday, Oct. 28, 2009. The flight test of Ares I-X will provide NASA with an early opportunity to test and prove flight characteristics, hardware, facilities and ground operations associated with the Ares I. Photo Credit: (NASA/Bill Ingalls)

Medicinal Herbs in Iranian Traditional Medicine for Learning and Memory.

PubMed

Shojaii, Asie; Ghods, Roshanak; Fard, Mehri Abdollahi

2016-05-01

A few factors such as age, stress, and emotions may lead to impaired learning, memory loss, amnesia, and dementia or threats like schizophrenia and Alzheimer's disease (AD). Iranian traditional medicine (ITM) recommends some herbs and herbal preparations for the treatment or prevention of CNS problems. In this study, scientific evidence related to the effectiveness of ITM herbal medicine on memory, learning and AD is reviewed. The scientific evidence of plant efficacy was searched in electronic databases including PubMed, Scopus, SID, Science Direct, and Google Scholar by keywords such as memory, Alzheimer, amnesia, learning and scientific plant names from 1969 to 2014. The findings of this study confirmed the effectiveness of certain ITM medicinal plants on enhancing memory and learning or in the treatment/prevention of amnesia and AD. Some ITM plants like Melissa officinalis, Crocus sativus and Nigella sativa showed improving effects on memory and the treatment of AD in clinical trials. In some cases, active principles responsible for the efficacy of these plants on memory were also determined. Most of the studies on ITM plants were designed in animal models and a few herbs were evaluated in clinical trials on AD. Furthermore, there are insufficient or no investigations on certain herbal medicines used in ITM to confirm their effectiveness on memory and learning. Therefore, further experimental and clinical studies are necessary to evaluate the effectiveness of these plants on memory and AD as well as determining their active components.

[Personalized medicine, privatized medicine? legal and public health stakes].

PubMed

Rial-Sebbag, Emmanuelle

2014-11-01

Personalized medicine is booming. It tends to provide a medical management "tailored" for groups of patients, or for one unique patient, but also to identify risk groups to develop public health strategies. In this context, some radicalization phenomenon can emerge, leading to not only personalized medicine but also privatized medicine, which can lead to a capture of the medical public resource. If the "privatization" of medicine is not limited to producing adverse effects, several potentially destabilizing phenomena for patients still remain. First, some objective factors, like the adjustment of scientific prerequisites, are emerging from personalized medicine practices (clinical trial, public health policy) and are interfering with the medical doctor/patient relationship. Another risk emerges for patients concomitantly to their demand for controlling their own health, in terms of patients' security although these risks are not clearly identified and not effectively communicated. These practices, related to a privatized medicine, develop within the healthcare system but also outside, and the government and legislators will have to take into account these new dimensions in drafting their future regulations and policies. © 2014 médecine/sciences – Inserm.

Small Space Launch: Origins & Challenges

NASA Astrophysics Data System (ADS)

Freeman, T.; Delarosa, J.

2010-09-01

The United States Space Situational Awareness capability continues to be a key element in obtaining and maintaining the high ground in space. Space Situational Awareness satellites are critical enablers for integrated air, ground and sea operations, and play an essential role in fighting and winning conflicts. The United States leads the world space community in spacecraft payload systems from the component level into spacecraft, and in the development of constellations of spacecraft. In the area of launch systems that support Space Situational Awareness, despite the recent development of small launch vehicles, the United States launch capability is dominated by an old, unresponsive and relatively expensive set of launchers in the Expandable, Expendable Launch Vehicles (EELV) platforms; Delta IV and Atlas V. The United States directed Air Force Space Command to develop the capability for operationally responsive access to space and use of space to support national security, including the ability to provide critical space capabilities in the event of a failure of launch or on-orbit capabilities. On 1 Aug 06, Air Force Space Command activated the Space Development & Test Wing (SDTW) to perform development, test and evaluation of Air Force space systems and to execute advanced space deployment and demonstration projects to exploit new concepts and technologies, and rapidly migrate capabilities to the warfighter. The SDTW charged the Launch Test Squadron (LTS) with the mission to develop the capability of small space launch, supporting government research and development space launches and missile defense target missions, with operationally responsive spacelift for Low-Earth-Orbit Space Situational Awareness assets as a future mission. This new mission created new challenges for LTS. The LTS mission tenets of developing space launches and missile defense target vehicles were an evolution from the squadrons previous mission of providing sounding rockets under the Rocket

14 CFR 420.30 - Launch site location review for permitted launch vehicles.

Code of Federal Regulations, 2010 CFR

2010-01-01

... AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LICENSE TO OPERATE A LAUNCH SITE Criteria and Information Requirements for Obtaining a License § 420.30 Launch site location review for...

14 CFR 420.30 - Launch site location review for permitted launch vehicles.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LICENSE TO OPERATE A LAUNCH SITE Criteria and Information Requirements for Obtaining a License § 420.30 Launch site location review for...

Launch Pad Activities

NASA Image and Video Library

1959-09-08

Big Joe Capsule Launch Pad Activities: This film covers both the Big Joe and a Little Joe Project Mercury flight test with a research and development version of the Mercury capsule. Big Joe was an Atlas missile that successfully launched a boilerplate model of the Mercury capsule on September 9, 1959. The lower half of the capsule was created at NASA Lewis. The scenes include coverage of the assembly and erection of the boosters, delivery of the capsules, mating of the capsules to the boosters, prelaunch views of the capsule and boosters on launchers, mission control, the launches, and recovery.

Powering Exploration: The Ares I Crew Launch Vehicle and Ares V Cargo Launch Vehicle

NASA Technical Reports Server (NTRS)

Cook, Stephen A.

2008-01-01

The National Aeronautics and Space Administration (NASA)'s Constellation Program is depending on the Ares Projects to deliver the crew and cargo launch capabilities needed to send human explorers to the Moon and beyond. The Ares Projects continue to make progress toward design, component testing, and early flight testing of the Ares I crew launch vehicle, as well as early design work for Ares V cargo launch vehicle. Ares I and Ares V will form the core space launch capabilities the United States needs to continue its pioneering tradition as a spacefaring nation. This paper will discuss programmatic, design, fabrication, and testing progress toward building these new launch vehicles.

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.

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

Complementary and alternative medicine for rheumatic diseases: A systematic review of randomized controlled trials.

PubMed

Phang, Jie Kie; Kwan, Yu Heng; Goh, Hendra; Tan, Victoria Ie Ching; Thumboo, Julian; Østbye, Truls; Fong, Warren

2018-04-01

To summarize all good quality randomized controlled trials (RCTs) using complementary and alternative medicine (CAM) interventions in patients with rheumatic diseases. A systematic literature review guided by the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) was performed. We excluded non-English language articles and abstract-only publications. Due to the large number of RCTs identified, we only include "good quality" RCTs with Jadad score of five. We identified 60 good quality RCTs using CAM as intervention for patients with rheumatic diseases: acupuncture (9), Ayurvedic treatment (3), homeopathic treatment (3), electricity (2), natural products (31), megavitamin therapies (8), chiropractic or osteopathic manipulation (3), and energy healing therapy (1). The studies do not seem to suggest a particular type of CAM is effective for all types for rheumatic diseases. However, some CAM interventions appear to be more effective for certain types of rheumatic diseases. Acupuncture appears to be beneficial for osteoarthritis but not rheumatoid arthritis. For the other therapeutic modalities, the evidence base either contains too few trials or contains trials with contradictory findings which preclude any definitive summary. There were only minor adverse reactions observed for CAM interventions presented. We identified 60 good quality RCTs which were heterogenous in terms of interventions, disease, measures used to assess outcomes, and efficacy of CAM interventions. Evidence indicates that some CAM therapies may be useful for rheumatic diseases, such as acupuncture for osteoarthritis. Further research with larger sample size is required for more conclusive evidence regarding efficacy of CAM interventions. Copyright © 2018 Elsevier Ltd. All rights reserved.

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.

NASA Exploration Launch Projects Overview: The Crew Launch Vehicle and the Cargo Launch Vehicle Systems

NASA Technical Reports Server (NTRS)

Snoddy, Jimmy R.; Dumbacher, Daniel L.; Cook, Stephen A.

2006-01-01

begins in 2008. Comprehensive reviews of engineering data and business assessments by both internal and independent reviewers serve as decision gates to ensure that systems can fully meet customer and stakeholder requirements. This paper provides the current CLV and CaLV configuration designs and gives examples of the progress being made during the first year of this significant effort. Safe, reliable, cost-effective space transportation systems are a foundational piece of America s future in space and the next step in realizing the plan for revitalizing lunar capabilities on the passageway to the human exploration of Mars. While building on legacy knowledge and heritage hardware for risk reduction, NASA will apply lessons learned from developing these new launch vehicles to the growth path for future missions. The elements for mission success and continued U.S. leadership in space have been assembled over the past year. As NASA designs and develops these two new systems over the next dozen years, visible progress, such as that reported in this paper, may sustain the national will to stay the course across political administrations and weather the inevitable trials that will be experienced during this challenging endeavor.

Launch Condition Deviations of Reusable Launch Vehicle Simulations in Exo-Atmospheric Zoom Climbs

NASA Technical Reports Server (NTRS)

Urschel, Peter H.; Cox, Timothy H.

2003-01-01

The Defense Advanced Research Projects Agency has proposed a two-stage system to deliver a small payload to orbit. The proposal calls for an airplane to perform an exo-atmospheric zoom climb maneuver, from which a second-stage rocket is launched carrying the payload into orbit. The NASA Dryden Flight Research Center has conducted an in-house generic simulation study to determine how accurately a human-piloted airplane can deliver a second-stage rocket to a desired exo-atmospheric launch condition. A high-performance, fighter-type, fixed-base, real-time, pilot-in-the-loop airplane simulation has been modified to perform exo-atmospheric zoom climb maneuvers. Four research pilots tracked a reference trajectory in the presence of winds, initial offsets, and degraded engine thrust to a second-stage launch condition. These launch conditions have been compared to the reference launch condition to characterize the expected deviation. At each launch condition, a speed change was applied to the second-stage rocket to insert the payload onto a transfer orbit to the desired operational orbit. The most sensitive of the test cases was the degraded thrust case, yielding second-stage launch energies that were too low to achieve the radius of the desired operational orbit. The handling qualities of the airplane, as a first-stage vehicle, have also been investigated.

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

Heart Rhythm Monitoring in the Constellation Lunar and Launch/Landing EVA Suit: Recommendations from an Expert Panel

NASA Technical Reports Server (NTRS)

Scheuring, Richard A.; Hamilton, Doug; Jones, Jeffrey A.; Alexander, David

2009-01-01

There are currently several physiological monitoring requirements for EVA in the Human-Systems Interface Requirements (HSIR) document. There are questions as to whether the capability to monitor heart rhythm in the lunar surface space suit is a necessary capability for lunar surface operations. Similarly, there are questions as to whether the capability to monitor heart rhythm during a cabin depressurization scenario in the launch/landing space suit is necessary. This presentation seeks to inform space medicine personnel of recommendations made by an expert panel of cardiovascular medicine specialists regarding in-suit ECG heart rhythm monitoring requirements during lunar surface operations. After a review of demographic information and clinical cases and panel discussion, the panel recommended that ECG monitoring capability as a clinical tool was not essential in the lunar space suit; ECG monitoring was not essential in the launch/landing space suit for contingency scenarios; the current hear rate monitoring capability requirement for both launch/landing and lunar space suits should be maintained; lunar vehicles should be required to have ECG monitoring capability with a minimum of 5-lead ECG for IVA medical assessments; and, exercise stress testing for astronaut selection and retention should be changed from the current 85% maximum heart rate limit to maximal, exhaustive 'symptom-limited' testing to maximize diagnostic utility as a screening tool for evaluating the functional capacity of astronauts and their cardiovascular health.

14 CFR 417.25 - Post launch report.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post launch...

14 CFR 417.25 - Post launch report.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post launch...

14 CFR 417.25 - Post launch report.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post launch...

14 CFR 417.25 - Post launch report.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post launch...

14 CFR 417.25 - Post launch report.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Post launch report. 417.25 Section 417.25... TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.25 Post launch report. (a) For a launch operator launching from a Federal launch range, a launch operator must file a post launch...

Evolved Expendable Launch Vehicle (EELV)

DTIC Science & Technology

2015-12-15

FY13+ Phase I Buy Contractor: United Launch Services, LLC Contractor Location: 9501 East Panorama Circle Centennial , CO 80112 Contract Number...Contract Name: FY13+ Phase I Buy Contractor: United Launch Services, LLC Contractor Location: 9501 East Panorama Circle Centennial , CO 80112 Contract...FY12 EELV Launch Services (ELS5) Contractor: United Launch Services, LLC. Contractor Location: 9501 East Panorama Circle Centennial , CO 80112

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

Recruitment strategies in two reproductive medicine network infertility trials.

PubMed

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

2015-11-01

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. 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. 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 the 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. 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. Copyright © 2015 Elsevier Inc. All rights reserved.

ARES I-X Launch Prep

NASA Image and Video Library

2009-10-26

NASA Ares I-X Assistant Launch Director Pete Nickolenko, left, and NASA Ares I-X Launch Director Ed Mango monitor the launch countdown from Firing Room One of the Launch Control Center (LCC) at the Kennedy Space Center during the planned launch of the Ares I-X rocket from pad 39b at the Kennedy Space Center in Cape Canaveral, Fla., Tuesday, Oct. 27, 2009. The flight test of Ares I-X will provide NASA with an early opportunity to test and prove flight characteristics, hardware, facilities and ground operations associated with the Ares I. Photo Credit: (NASA/Bill Ingalls)

Throttleable GOX/ABS launch assist hybrid rocket motor for small scale air launch platform

NASA Astrophysics Data System (ADS)

Spurrier, Zachary S.

Aircraft-based space-launch platforms allow operational flexibility and offer the potential for significant propellant savings for small-to-medium orbital payloads. The NASA Armstrong Flight Research Center's Towed Glider Air-Launch System (TGALS) is a small-scale flight research project investigating the feasibility for a remotely-piloted, towed, glider system to act as a versatile air launch platform for nano-scale satellites. Removing the crew from the launch vehicle means that the system does not have to be human rated, and offers a potential for considerable cost savings. Utah State University is developing a small throttled launch-assist system for the TGALS platform. This "stage zero" design allows the TGALS platform to achieve the required flight path angle for the launch point, a condition that the TGALS cannot achieve without external propulsion. Throttling is required in order to achieve and sustain the proper launch attitude without structurally overloading the airframe. The hybrid rocket system employs gaseous-oxygen and acrylonitrile butadiene styrene (ABS) as propellants. This thesis summarizes the development and testing campaign, and presents results from the clean-sheet design through ground-based static fire testing. Development of the closed-loop throttle control system is presented.

76 FR 52694 - National Environmental Policy Act: Launch of NASA Routine Payloads on Expendable Launch Vehicles

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-23

...: Launch of NASA Routine Payloads on Expendable Launch Vehicles AGENCY: National Aeronautics and Space Administration (NASA). ACTION: Notice of availability and request for comments on the draft environmental assessment (``Draft EA'') for launch of NASA routine payloads on expendable launch vehicles. SUMMARY...

Launch, Jupiter-C, Explorer 1

NASA Technical Reports Server (NTRS)

1958-01-01

Launch of Jupiter-C/Explorer 1 at Cape Canaveral, Florida on January 31, 1958. After the Russian Sputnik 1 was launched in October 1957, the launching of an American satellite assumed much greater importance. After the Vanguard rocket exploded on the pad in December 1957, the ability to orbit a satellite became a matter of national prestige. On January 31, 1958, slightly more than four weeks after the launch of Sputnik.The ABMA (Army Ballistic Missile Agency) in Redstone Arsenal, Huntsville, Alabama, in cooperation with the Jet Propulsion Laboratory, launched a Jupiter from Cape Canaveral, Florida. The rocket consisted of a modified version of the Redstone rocket's first stage and two upper stages of clustered Baby Sergeant rockets developed by the Jet Propulsion Laboratory and later designated as Juno boosters for space launches

Advanced small launch vehicle study

NASA Technical Reports Server (NTRS)

Reins, G. E.; Alvis, J. F.

1972-01-01

A conceptual design study was conducted to determine the most economical (lowest cost/launch) approach for the development of an advanced small launch vehicle (ASLV) for use over the next decade. The ASLV design objective was to place a 340 kg (750 lb) payload into a 556 km (300 n.mi.) circular orbit when launched due east from Wallops Island, Virginia. The investigation encompassed improvements to the current Scout launch vehicle; use of existing military and NASA launch vehicle stages; and new, optionally staged vehicles. Staging analyses included use of liquid, solid, and hybrid propellants. Improvements in guidance, controls, interstages, telemetry, and payload shroud were also considered. It was concluded that the most economical approach is to progressively improve the Scout launch vehicle in three phased steps which are discussed.

Apollo 4 launch

NASA Image and Video Library

1967-09-11

S67-50903 (9 Nov. 1967) --- The Apollo 4 (Spacecraft 017/Saturn 501) space mission was launched from Pad A, Launch Complex 39, Kennedy Space Center, Florida. The liftoff of the huge 363-feet tall Apollo/Saturn V space vehicle was at 7:00:01 a.m. (EST), Nov. 9, 1967. The successful objectives of the Apollo 4 Earth-orbital unmanned space mission obtained included (1) flight information on launch vehicle and spacecraft structural integrity and compatibility, flight loads, stage separation, subsystem operation, emergency detection subsystem, and (2) evaluation of the Apollo Command Module heat shield under conditions encountered on return from a moon mission.

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.

Alternative Medicine and Alzheimer's Disease

PubMed Central

Kelley, Brendan J.; Knopman, David S.

2009-01-01

Background Alternative medicine has an extensive worldwide history and is commonly used by older patients. A number of different alternative medicines are used by patients having Alzheimer's disease. It is both desirable and expected for clinicians to be acquainted with these medications. Review Summary This paper discusses the available clinical trial evidence regarding eight agents commonly used by people having Alzheimer's disease. We provide an overview of the history and basic scientific evidence available for each agent, followed by a critical analysis of the evidence available from clinical trials, including the number of participants, trial duration and specific outcomes evaluated. Conclusion While many of these compounds have been associated with interesting basic science, none has shown clear clinical benefit to date. Data available for some, such as ginkgo biloba, curcumin and huperzine A, suggest that further evaluation is warranted. Familiarity with this literature will allow clinicians to provide meaningful recommendations to patients who wish to use these agents. PMID:18784599

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)

14 CFR 417.125 - Launch of an unguided suborbital launch vehicle.

Code of Federal Regulations, 2010 CFR

2010-01-01

... elevation angle setting that ensures the rocket will not fly uprange. A launch operator must set the... throughout each stage of powered flight. A caliber, for a rocket configuration, is defined as the distance... rocket configuration. (f) Tracking. A launch operator must track the flight of an unguided suborbital...

14 CFR 417.125 - Launch of an unguided suborbital launch vehicle.

Code of Federal Regulations, 2013 CFR

2013-01-01

... elevation angle setting that ensures the rocket will not fly uprange. A launch operator must set the... throughout each stage of powered flight. A caliber, for a rocket configuration, is defined as the distance... rocket configuration. (f) Tracking. A launch operator must track the flight of an unguided suborbital...

14 CFR 417.125 - Launch of an unguided suborbital launch vehicle.

Code of Federal Regulations, 2012 CFR

2012-01-01

... elevation angle setting that ensures the rocket will not fly uprange. A launch operator must set the... throughout each stage of powered flight. A caliber, for a rocket configuration, is defined as the distance... rocket configuration. (f) Tracking. A launch operator must track the flight of an unguided suborbital...

14 CFR 417.125 - Launch of an unguided suborbital launch vehicle.

Code of Federal Regulations, 2011 CFR

2011-01-01

... elevation angle setting that ensures the rocket will not fly uprange. A launch operator must set the... throughout each stage of powered flight. A caliber, for a rocket configuration, is defined as the distance... rocket configuration. (f) Tracking. A launch operator must track the flight of an unguided suborbital...

14 CFR 417.125 - Launch of an unguided suborbital launch vehicle.

Code of Federal Regulations, 2014 CFR

2014-01-01

... elevation angle setting that ensures the rocket will not fly uprange. A launch operator must set the... throughout each stage of powered flight. A caliber, for a rocket configuration, is defined as the distance... rocket configuration. (f) Tracking. A launch operator must track the flight of an unguided suborbital...

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

Medicine As a Corporate Enterprise, Patient Welfare Centered Profession, or Patient Welfare Centered Professional Enterprise?

PubMed Central

Singh, Ajai; Singh, Shakuntala

2005-01-01

There is an alarming trend in the field of medicine, whose portents are ominous but do not seem to shake the complacency and merry making doing the rounds. The wants of the medical man have multiplied beyond imagination. The cost of organizing conferences is no longer possible on delegate fees. The bottom-line is: Crores for a Conference Millions for a Mid-Term. However, the problem is that sponsors keep a discreet but careful tab on docs. All in all, costs of medicines escalate, and quality medical care becomes a luxury. The whole brunt of this movement is borne by the patient. Companies like GlaxoSmithKline, Bayer, Pfizer, Bristol-Myers Squibb, AstraZeneca, Schering-Plough, Abbott Labs, TAP Pharmaceuticals, Wyeth and Merck have paid millions of dollars each as compensation in the last few years. The financial condition of many pharmaceutical majors is not buoyant either. Price deflation, increased Rand D spending, and litigation costs are the main reasons. In the future, the messy lawsuits situation would no longer be restricted to industry. It would involve academia and practising doctors as well. Indian pharma industry captains, who were busy raking in the profits at present, would also come under the scanner. If nothing else, it means industry and docs will have to sit down and do some soul searching. Both short and long-term measures will have to be put into place. Short-term measures involve reduction in i) pharma spending over junkets and trinkets; ii) hype over ‘me too’ drugs; iii) manipulation of drug trials; iv) getting pliant researchers into drug trials; iv) manipulation of Journal Editors to publish positive findings about their drug trials and launches; v) and for Indian Pharma, to conduct their own unbiased clinical trial of the latest drug projected as a blockbuster in the West, before pumping in their millions. The long-term measures are related to the way biomedical advance is to be charted. We have to decide whether medicine is to become a

Medicine as a corporate enterprise, patient welfare centered profession, or patient welfare centered professional enterprise?

PubMed

Singh, Ajai; Singh, Shakuntala

2005-11-01

There is an alarming trend in the field of medicine, whose portents are ominous but do not seem to shake the complacency and merry making doing the rounds.The wants of the medical man have multiplied beyond imagination. The cost of organizing conferences is no longer possible on delegate fees. The bottom-line is: Crores for a Conference Millions for a Mid-Term. However, the problem is that sponsors keep a discreet but careful tab on docs. All in all, costs of medicines escalate, and quality medical care becomes a luxury. The whole brunt of this movement is borne by the patient.Companies like GlaxoSmithKline, Bayer, Pfizer, Bristol-Myers Squibb, AstraZeneca, Schering-Plough, Abbott Labs, TAP Pharmaceuticals, Wyeth and Merck have paid millions of dollars each as compensation in the last few years. The financial condition of many pharmaceutical majors is not buoyant either. Price deflation, increased Rand D spending, and litigation costs are the main reasons. In the future, the messy lawsuits situation would no longer be restricted to industry. It would involve academia and practising doctors as well. Indian pharma industry captains, who were busy raking in the profits at present, would also come under the scanner. If nothing else, it means industry and docs will have to sit down and do some soul searching.Both short and long-term measures will have to be put into place. Short-term measures involve reduction in i) pharma spending over junkets and trinkets; ii) hype over 'me too' drugs; iii) manipulation of drug trials; iv) getting pliant researchers into drug trials; iv) manipulation of Journal Editors to publish positive findings about their drug trials and launches; v) and for Indian Pharma, to conduct their own unbiased clinical trial of the latest drug projected as a blockbuster in the West, before pumping in their millions.The long-term measures are related to the way biomedical advance is to be charted. We have to decide whether medicine is to become a corporate

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

Clinical Trials

MedlinePlus

... pill that has no medicine in it. Most times participants do not know which they are receiving. Other clinical trials involve a crossover design, where participants are randomly assigned to take a ...

Structured patient handoff on an internal medicine ward: A cluster randomized control trial.

PubMed

Tam, Penny; Nijjar, Aman P; Fok, Mark; Little, Chris; Shingina, Alexandra; Bittman, Jesse; Raghavan, Rashmi; Khan, Nadia A

2018-01-01

The effect of a multi-faceted handoff strategy in a high volume internal medicine inpatient setting on process and patient outcomes has not been clearly established. We set out to determine if a multi-faceted handoff intervention consisting of education, standardized handoff procedures, including fixed time and location for face-to-face handoff would result in improved rates of handoff compared with usual practice. We also evaluated resident satisfaction, health resource utilization and clinical outcomes. This was a cluster randomized controlled trial in a large academic tertiary care center with 18 inpatient internal medicine ward teams from January-April 2013. We randomized nine inpatient teams to an intervention where they received an education session standardizing who and how to handoff patients, with practice and feedback from facilitators. The control group of 9 teams continued usual non-standardized handoffs. The primary process outcome was the rate of patients handed over per 1000 patient nights. Other process outcomes included perceptions of inadequate handoff by overnight physicians, resource utilization overnight and hospital length of stay. Clinical outcomes included medical errors, frequency of patients requiring higher level of care overnight, and in-hospital mortality. The intervention group demonstrated a significant increase in the rate of patients handed over to the overnight physician (62.90/1000 person-nights vs. 46.86/1000 person-nights, p = 0.002). There was no significant difference in other process outcomes except resource utilization was increased in the intervention group (26.35/1000 person-days vs. 17.57/1000 person-days, p-value = 0.01). There was no significant difference between groups in medical errors (4.8% vs. 4.1%), need for higher level of care or in hospital mortality. Limitations include a dependence of accurate record keeping by the overnight physician, the possibility of cross-contamination in the handoff process, analysis at

Ethical quandaries in spiritual healing and herbal medicine: a critical analysis of the morality of traditional medicine advertising in southern African urban societies.

PubMed

Munyaradzi, Mawere

2011-01-01

This paper critically examines the morality of advertising by practitioners in spiritual healing and herbal medicine heretofore referred to as traditional medicine, in southern African urban societies. While the subject of traditional medicine has been heavily contested in medical studies in the last few decades, the monumental studies on the subject have emphasised the place of traditional medicine in basic health services. Insignificant attention has been devoted to examine the ethical problems associated with traditional medicine advertising. Critical look at the worthiness of some advertising strategies used by practitioners in traditional medicine in launching their products and services on market thus has been largely ignored. Yet, though advertising is key to helping traditional medicine practitioners' products and services known by prospective customers, this research registers a number of morally negative effects that seem to outweigh the merits that the activity brings to prospective customers. The paper adopts southern African urban societies, and in particular Mozambique, South Africa and Zimbabwe as particular references. The choice of the trio is not accidental, but based on the fact that these countries have in the last few decades been flooded with traditional medicine practitioners/traditional healers from within the continent and from abroad. Most of these practitioners use immoral advertising strategies in communicating to the public the products and services they offer. It is against this background that this paper examines the morality of advertising strategies deployed by practitioners in launching their products and services. To examine the moral worthiness of the advertising strategies used by traditional medical practitioners, I used qualitative analysis of street adverts as well as electronic and print media. From the results obtained through thematic content analysis, the paper concludes that most of the practitioners in traditional

A National Strategy to Develop Pragmatic Clinical Trials Infrastructure

PubMed Central

Guise, Jeanne‐Marie; Dolor, Rowena J.; Meissner, Paul; Tunis, Sean; Krishnan, Jerry A.; Pace, Wilson D.; Saltz, Joel; Hersh, William R.; Michener, Lloyd; Carey, Timothy S.

2014-01-01

Abstract An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1‐year learning network to identify high‐priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three‐stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1‐day network meeting at the end of the year. The year‐long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials. PMID:24472114

Clinical trials. A pending subject.

PubMed

Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

2018-04-01

Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

U.S. advanced launch vehicle technology programs : Quarterly Launch Report : special report

DOT National Transportation Integrated Search

1996-01-01

U.S. firms and U.S. government agencies are jointly investing in advanced launch vehicle technology. This Special Report summarizes U.S. launch vehicle technology programs and highlights the changing : roles of government and industry players in pick...

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

New Horizons Launch Contingency Effort

NASA Astrophysics Data System (ADS)

Chang, Yale; Lear, Matthew H.; McGrath, Brian E.; Heyler, Gene A.; Takashima, Naruhisa; Owings, W. Donald

2007-01-01

On 19 January 2006 at 2:00 PM EST, the NASA New Horizons spacecraft (SC) was launched from the Cape Canaveral Air Force Station (CCAFS), FL, onboard an Atlas V 551/Centaur/STAR™ 48B launch vehicle (LV) on a mission to explore the Pluto Charon planetary system and possibly other Kuiper Belt Objects. It carried a single Radioisotope Thermoelectric Generator (RTG). As part of the joint NASA/US Department of Energy (DOE) safety effort, contingency plans were prepared to address the unlikely events of launch accidents leading to a near-pad impact, a suborbital reentry, an orbital reentry, or a heliocentric orbit. As the implementing organization. The Johns Hopkins University Applied Physics Laboratory (JHU/APL) had expanded roles in the New Horizons launch contingency effort over those for the Cassini mission and Mars Exploration Rovers missions. The expanded tasks included participation in the Radiological Control Center (RADCC) at the Kennedy Space Center (KSC), preparation of contingency plans, coordination of space tracking assets, improved aerodynamics characterization of the RTG's 18 General Purpose Heat Source (GPHS) modules, and development of spacecraft and RTG reentry breakup analysis tools. Other JHU/APL tasks were prediction of the Earth impact footprints (ElFs) for the GPHS modules released during the atmospheric reentry (for purposes of notification and recovery), prediction of the time of SC reentry from a potential orbital decay, pre-launch dissemination of ballistic coefficients of various possible reentry configurations, and launch support of an Emergency Operations Center (EOC) on the JHU/APL campus. For the New Horizons launch, JHU/APL personnel at the RADCC and at the EOC were ready to implement any real-time launch contingency activities. A successful New Horizons launch and interplanetary injection precluded any further contingency actions. The New Horizons launch contingency was an interagency effort by several organizations. This paper

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.

Magnetic Launch Assist Demonstration Test

NASA Technical Reports Server (NTRS)

2001-01-01

This image shows a 1/9 subscale model vehicle clearing the Magnetic Launch Assist System, formerly referred to as the Magnetic Levitation (MagLev), test track during a demonstration test conducted at the Marshall Space Flight Center (MSFC). Engineers at MSFC have developed and tested Magnetic Launch Assist technologies. To launch spacecraft into orbit, a Magnetic Launch Assist System would use magnetic fields to levitate and accelerate a vehicle along a track at very high speeds. Similar to high-speed trains and roller coasters that use high-strength magnets to lift and propel a vehicle a couple of inches above a guideway, a launch-assist system would electromagnetically drive a space vehicle along the track. A full-scale, operational track would be about 1.5-miles long and capable of accelerating a vehicle to 600 mph in 9.5 seconds. This track is an advanced linear induction motor. Induction motors are common in fans, power drills, and sewing machines. Instead of spinning in a circular motion to turn a shaft or gears, a linear induction motor produces thrust in a straight line. Mounted on concrete pedestals, the track is 100-feet long, about 2-feet wide and about 1.5-feet high. The major advantages of launch assist for NASA launch vehicles is that it reduces the weight of the take-off, the landing gear, the wing size, and less propellant resulting in significant cost savings. The US Navy and the British MOD (Ministry of Defense) are planning to use magnetic launch assist for their next generation aircraft carriers as the aircraft launch system. The US Army is considering using this technology for launching target drones for anti-aircraft training.

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.

Bulk-buy practices by satellite operators foster further commercialization of launch services industry : Quarterly Launch Report : special report

DOT National Transportation Integrated Search

1997-01-01

The satellite launch industry has steadily grown and matured to take on the features of a truly commercial industry. This year, commercial launches outnumber government launches for the first time. New launch systems, such as the Delta 3, Sea Launch,...

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

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)

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)

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)

Herbal Medicine in the Treatment of Ulcerative Colitis

PubMed Central

Ke, Fei; Yadav, Praveen Kumar; Ju, Liu Zhan

2012-01-01

Ulcerative colitis (UC) is a refractory, chronic, and nonspecific disease occurred usually in the rectum and the entire colon. The etiopathology is probably related to dysregulation of the mucosal immune response toward the resident bacterial flora together with genetic and environmental factors. Several types of medications are used to control the inflammation or reduce symptoms. Herbal medicine includes a wide range of practices and therapies outside the realms of conventional Western medicine. However, there are limited controlled evidences indicating the efficacy of traditional Chinese medicines, such as aloe vera gel, wheat grass juice, Boswellia serrata, and bovine colostrum enemas in the treatment of UC. Although herbal medicines are not devoid of risk, they could still be safer than synthetic drugs. The potential benefits of herbal medicine could lie in their high acceptance by patients, efficacy, relative safety, and relatively low cost. Patients worldwide seem to have adopted herbal medicine in a major way, and the efficacy of herbal medicine has been tested in hundreds of clinical trials in the management of UC. The evidences on herbal medicine are incomplete, complex, and confusing, and certainly associated with both risks and benefits. There is a need for further controlled clinical trials of the potential efficacy of herbal medicine approaches in the treatment of UC, together with enhanced legislation to maximize their quality and safety. PMID:22249085

Palliative Care Exposure in Internal Medicine Residency Education: A Survey of ACGME Internal Medicine Program Directors.

PubMed

Edwards, Asher; Nam, Samuel

2018-01-01

As the baby boomer generation ages, the need for palliative care services will be paramount and yet training for palliative care physicians is currently inadequate to meet the current palliative care needs. Nonspecialty-trained physicians will need to supplement the gap between supply and demand. Yet, no uniform guidelines exist for the training of internal medicine residents in palliative care. To our knowledge, no systematic study has been performed to evaluate how internal medicine residencies currently integrate palliative care into their training. In this study, we surveyed 338 Accreditation Council for Graduate Medical Education-accredited internal medicine program directors. We queried how palliative care was integrated into their training programs. The vast majority of respondents felt that palliative care training was "very important" (87.5%) and 75.9% of respondents offered some kind of palliative care rotation, often with a multidisciplinary approach. Moving forward, we are hopeful that the data provided from our survey will act as a launching point for more formal investigations into palliative care education for internal medicine residents. Concurrently, policy makers should aid in palliative care instruction by formalizing required palliative care training for internal medicine residents.

[Basic principles, planning and implementation of non-commercial clinical trials].

PubMed

Finger, R P; Coch, C; Coenen, M; Mengel, M; Hartmann, G; Holz, F G

2011-01-01

The proof of a drug's efficacy in randomized controlled trials is fundamental to therapeutic concepts determined by evidence-based medicine. Clinical trials according to the German Medicinal Products Act are performed by the pharmaceutical industry as company-sponsored trials (CST) driven by commercial interests or by non-commercial facilities as investigator-initiated trials (IIT), typically implemented by University Hospitals. In areas with no commercial interest, IITs are the driving force that generate scientific progress leading to treatment optimization. Therefore, non-commercial or investigator-initiated clinical trials are indispensable for improving medical care. To ensure the safety of trial participants and the quality of the data obtained, clinical trials are controlled by many legal regulations and internationally accepted quality standards. Therefore implementation of a clinical trial requires profound knowledge, qualified personnel, appropriate infrastructure, and substantial financial resources. In IITs unlike CSTs this has to be accomplished by the University without the assistance of the pharmaceutical industry. Since teaching of skills needed to perform clinical trials is still largely neglected in medical school and during residency this review addresses the (in clinical trials) inexperienced physician and outlines the characterization of a clinical trial, the range and division of responsibilities and the performance of clinical trials according to the German Medicinal Products Act.

Russian Soyuz Moves to Launch Pad

NASA Technical Reports Server (NTRS)

2000-01-01

The Soyuz TM-31 launch vehicle, which carried the first resident crew to the International Space Station, moves toward the launch pad at the Baikonur complex in Kazakhstan. The Russian Soyuz launch vehicle is an expendable spacecraft that evolved out of the original Class A (Sputnik). From the early 1960' 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.

SLI Artist `s Launch Concept

NASA Technical Reports Server (NTRS)

2002-01-01

NASA's Marshall Space Flight Center in Huntsville, Alabama, manages the Space Launch Initiative (SLI), NASA's priority developmental program focused on empowering America's leadership in space. SLI includes commercial, higher education and defense partnerships and contracts to offer widespread participation in both the risk and success of developing our nation's next-generation reusable launch vehicle. This photo depicts an artist's concept of a future second-generation launch vehicle during launch. For SLI, architecture definition includes all components of the next-generation reusable launch system: Earth-to-orbit vehicles (the Space Shuttle is the first generation earth-to-orbit vehicle), crew transfer vehicles, transfer stages, ground processing systems, flight operations systems, and development of business case strategies. Three contractor teams have each been funded to develop potential second generation reusable launch system architectures: The Boeing Company of Seal Beach, California; Lockheed Martin Corporation of Denver, Colorado along with a team including Northrop Grumman of El Segundo, California; and Orbital Sciences Corporation of Dulles, Virginia.

Magnetic Launch Assist System-Artist's Concept

NASA Technical Reports Server (NTRS)

1999-01-01

This illustration is an artist's concept of a Magnetic Launch Assist System, formerly referred as the Magnetic Levitation (Maglev) system, for space launch. Overcoming the grip of Earth's gravity is a supreme challenge for engineers who design rockets that leave the planet. Engineers at the Marshall Space Flight Center have developed and tested Magnetic Launch Assist System technologies that could levitate and accelerate a launch vehicle along a track at high speeds before it leaves the ground. Using electricity and magnetic fields, a Magnetic Launch Assist system would drive a spacecraft along a horizontal track until it reaches desired speeds. A full-scale, operational track would be about 1.5-miles long and capable of accelerating a vehicle to 600 mph in 9.5 seconds. The major advantages of launch assist for NASA launch vehicles is that it reduces the weight of the take-off, landing gear and the wing size, as well as the elimination of propellant weight resulting in significant cost savings. The US Navy and the British MOD (Ministry of Defense) are planning to use magnetic launch assist for their next generation aircraft carriers as the aircraft launch system. The US Army is considering using this technology for launching target drones for anti-aircraft training.

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)

Aquarius SAC-D Launch

NASA Image and Video Library

2011-06-10

A Delta II rocket launches with the Aquarius/SAC-D spacecraft payload from Space Launch Complex 2 at Vandenberg Air Force Base, Calif. on Friday, June 10, 2011. The joint U.S./Argentinian Aquarius/Satélite de Aplicaciones Científicas (SAC)-D mission, set to launch June 10, will map the salinity at the ocean surface, information critical to improving our understanding of two major components of Earth's climate system: the water cycle and ocean circulation. Photo Credit: (NASA/Bill Ingalls)

InSight Launch

NASA Image and Video Library

2018-05-05

The NASA InSight spacecraft launches onboard a United Launch Alliance Atlas-V rocket, Saturday, May 5, 2018, from Vandenberg Air Force Base in California. InSight, short for Interior Exploration using Seismic Investigations, Geodesy and Heat Transport, is a Mars lander designed to study the "inner space" of Mars: its crust, mantle, and core. Photo Credit: (NASA/Bill Ingalls)

Magnetic Launch Assist Vehicle-Artist's Concept

NASA Technical Reports Server (NTRS)

1999-01-01

This artist's concept depicts a Magnetic Launch Assist vehicle clearing the track and shifting to rocket engines for launch into orbit. The system, formerly referred as the Magnetic Levitation (MagLev) system, is a launch system developed and tested by Engineers at the Marshall Space Flight Center (MSFC) that could levitate and accelerate a launch vehicle along a track at high speeds before it leaves the ground. Using an off-board electric energy source and magnetic fields, a Magnetic Launch Assist system would drive a spacecraft along a horizontal track until it reaches desired speeds. The system is similar to high-speed trains and roller coasters that use high-strength magnets to lift and propel a vehicle a couple of inches above a guideway. A full-scale, operational track would be about 1.5-miles long, capable of accelerating a vehicle to 600 mph in 9.5 seconds, and the vehicle would then shift to rocket engines for launch into orbit. The major advantages of launch assist for NASA launch vehicles is that it reduces the weight of the take-off, the landing gear, the wing size, and less propellant resulting in significant cost savings. The US Navy and the British MOD (Ministry of Defense) are planning to use magnetic launch assist for their next generation aircraft carriers as the aircraft launch system. The US Army is considering using this technology for launching target drones for anti-aircraft training.

Health is primary: Family medicine for America's health.

PubMed

Phillips, Robert L; Pugno, Perry A; Saultz, John W; Tuggy, Michael L; Borkan, Jeffrey M; Hoekzema, Grant S; DeVoe, Jennifer E; Weida, Jane A; Peterson, Lars E; Hughes, Lauren S; Kruse, Jerry E; Puffer, James C

2014-10-01

More than a decade ago the American Academy of Family Physicians, American Academy of Family Physicians Foundation, American Board of Family Medicine, Association of Departments of Family Medicine, Association of Family Practice Residency Directors, North American Primary Care Research Group, and Society of Teachers of Family Medicine came together in the Future of Family Medicine (FFM) to launch a series of strategic efforts to "renew the specialty to meet the needs of people and society," some of which bore important fruit. Family Medicine for America's Health was launched in 2013 to revisit the role of family medicine in view of these changes and to position family medicine with new strategic and communication plans to create better health, better health care, and lower cost for patients and communities (the Triple Aim). Family Medicine for America's Health was preceded and guided by the development of a family physician role definition. A consulting group facilitated systematic strategic plan development over 9 months that included key informant interviews, formal stakeholder surveys, future scenario testing, a retreat for family medicine organizations and stakeholder representatives to review strategy options, further strategy refinement, and finally a formal strategic plan with draft tactics and design for an implementation plan. A second communications consulting group surveyed diverse stakeholders in coordination with strategic planning to develop a communication plan. The American College of Osteopathic Family Physicians joined the effort, and students, residents, and young physicians were included. The core strategies identified include working to ensure broad access to sustained, primary care relationships; accountability for increasing primary care value in terms of cost and quality; a commitment to helping reduce health care disparities; moving to comprehensive payment and away from fee-for-service; transformation of training; technology to support

A Systematic Review of Herbal Medicine for Chemotherapy Induced Peripheral Neuropathy

PubMed Central

Noh, Hyeonseok

2018-01-01

Background Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect in cancer patients. The aim of this review was to assess the effectiveness of herbal medicine in preventing and treating CIPN. Methods Randomised controlled trials were included in this review. Extracting and assessing the data independently, two authors searched 13 databases. Results Twenty-eight trials involving 2174 patients met the inclusion criteria. Although there were some exceptions, the methodological quality was typically low. Seventeen trials reported the incidence rate of CIPN assessed by various tools and 14 showed a significant difference regarding the decrease of the incidence rate between the two groups. For clinical improvement, 12 trials reported it using various tools and 10 showed a significant difference between two groups. Two cases of adverse events occurred in one trial; the other nine trials reported no adverse events. Conclusions We found that herbal medicines in combination with and/or without other therapies potentially have preventive or therapeutic effects on CIPN. However, conclusions cannot be drawn because of the generally low quality of the methodology, the clinical heterogeneity, and the small sample size for each single herbal medicine. Trials that are more rigorous and report sufficient methodological data are needed. PMID:29636782

Constellation Ground Systems Launch Availability Analysis: Enhancing Highly Reliable Launch Systems Design

NASA Technical Reports Server (NTRS)

Gernand, Jeffrey L.; Gillespie, Amanda M.; Monaghan, Mark W.; Cummings, Nicholas H.

2010-01-01

Success of the Constellation Program's lunar architecture requires successfully launching two vehicles, Ares I/Orion and Ares V/Altair, in a very limited time period. The reliability and maintainability of flight vehicles and ground systems must deliver a high probability of successfully launching the second vehicle in order to avoid wasting the on-orbit asset launched by the first vehicle. The Ground Operations Project determined which ground subsystems had the potential to affect the probability of the second launch and allocated quantitative availability requirements to these subsystems. The Ground Operations Project also developed a methodology to estimate subsystem reliability, availability and maintainability to ensure that ground subsystems complied with allocated launch availability and maintainability requirements. The verification analysis developed quantitative estimates of subsystem availability based on design documentation; testing results, and other information. Where appropriate, actual performance history was used for legacy subsystems or comparative components that will support Constellation. The results of the verification analysis will be used to verify compliance with requirements and to highlight design or performance shortcomings for further decision-making. This case study will discuss the subsystem requirements allocation process, describe the ground systems methodology for completing quantitative reliability, availability and maintainability analysis, and present findings and observation based on analysis leading to the Ground Systems Preliminary Design Review milestone.

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.

ARES I-X Launch

NASA Image and Video Library

2009-10-27

NASA Ares I-X Launch Director Ed Mango, 3rd from left, along with other mission managers watches the launch of the Ares I-X rocket from Firing Room One of the Launch Control Center (LCC) at the Kennedy Space Center in Cape Canaveral, Fla., Wednesday, Oct. 28, 2009. The flight test of Ares I-X will provide NASA with an early opportunity to test and prove flight characteristics, hardware, facilities and ground operations associated with the Ares I. Photo Credit: (NASA/Bill Ingalls)

ARES I-X Launch Prep

NASA Image and Video Library

2009-10-26

NASA Ares I-X Launch Director Ed Mango monitors the launch countdown from Firing Room One of the Launch Control Center (LCC) at the Kennedy Space Center during the planned launch of the Ares I-X rocket from pad 39b at the Kennedy Space Center in Cape Canaveral, Fla., Tuesday, Oct. 27, 2009. The flight test of Ares I-X will provide NASA with an early opportunity to test and prove flight characteristics, hardware, facilities and ground operations associated with the Ares I. Photo Credit: (NASA/Bill Ingalls)

Evolved Expendable Launch Vehicle: DOD Is Assessing Data on Worldwide Launch Market to Inform New Acquisition Strategy

DTIC Science & Technology

2016-07-22

Launch Services (ILS) of a Proton M launch vehicle and one provided by Space Exploration Technologies ( SpaceX ) of a Falcon 9 launch vehicle — and...U.S. based providers are United Launch Alliance (ULA), Space Exploration Technologies Corporation ( SpaceX ), and Orbital ATK. Countries we reviewed

STS Derived Exploration Launch Operations

NASA Technical Reports Server (NTRS)

Best, Joel; Sorge, L.; Siders, J.; Sias, Dave

2004-01-01

A key aspect of the new space exploration programs will be the approach to optimize launch operations. A STS Derived Launch Vehicle (SDLV) Program can provide a cost effective, low risk, and logical step to launch all of the elements of the exploration program. Many benefits can be gained by utilizing the synergy of a common launch site as an exploration spaceport as well as evolving the resources of the current Space Shuttle Program (SSP) to meet the challenges of the Vision for Space Exploration. In particular, the launch operation resources of the SSP can be transitioned to the exploration program and combined with the operations efficiencies of unmanned EELVs to obtain the best of both worlds, resulting in lean launch operations for crew and cargo missions of the exploration program. The SDLV Program would then not only capture the extensive human space flight launch operations knowledge, but also provide for the safe fly-out of the SSP through continuity of system critical skills, manufacturing infrastructure, and ability to maintain and attract critical skill personnel. Thus, a SDLV Program can smoothly transition resources from the SSP and meet the transportation needs to continue the voyage of discovery of the space exploration program.

Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations.

PubMed

Lehmann, Birka

2008-12-08

Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective.The same approach may not always be applied to medicinal products used to treat children.Studies showed that over 50% of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products "off-label" and to use unauthorised products with the associated risks of inefficacy and/or adverse reactions.The Regulation (EC) No 1901/2006 sets up a system of requirements, rewards and incentives, together with horizontal measures, to ensure that medicinal products are researched, developed and authorised to meet the therapeutic needs of children.The Regulation is addressed to: 1. The pharmaceutical industry by setting out the legal framework for receiving rewards and incentives by conducting clinical trials in the paediatric population. 2. The Member States to set out to support research into, and the development and availability of, medicinal products for paediatric use. 3. The Community as funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate. The legal framework for conducting clinical trials, including children/minors, is set up in Directive 2001/20/EC, the Clinical Trials Directive (CTD), for the European Union (EU). The CTD establishes specific provisions regarding conduct of clinical trials, including multi

Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations

PubMed Central

Lehmann, Birka

2008-01-01

Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective. The same approach may not always be applied to medicinal products used to treat children. Studies showed that over 50% of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products "off-label" and to use unauthorised products with the associated risks of inefficacy and/or adverse reactions. The Regulation (EC) No 1901/2006 sets up a system of requirements, rewards and incentives, together with horizontal measures, to ensure that medicinal products are researched, developed and authorised to meet the therapeutic needs of children. The Regulation is addressed to: 1. The pharmaceutical industry by setting out the legal framework for receiving rewards and incentives by conducting clinical trials in the paediatric population. 2. The Member States to set out to support research into, and the development and availability of, medicinal products for paediatric use. 3. The Community as funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate. The legal framework for conducting clinical trials, including children/minors, is set up in Directive 2001/20/EC, the Clinical Trials Directive (CTD), for the European Union (EU). The CTD establishes specific provisions regarding conduct of clinical trials, including

Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy.

PubMed

Shang, Aijing; Huwiler-Müntener, Karin; Nartey, Linda; Jüni, Peter; Dörig, Stephan; Sterne, Jonathan A C; Pewsner, Daniel; Egger, Matthias

Homoeopathy is widely used, but specific effects of homoeopathic remedies seem implausible. Bias in the conduct and reporting of trials is a possible explanation for positive findings of trials of both homoeopathy and conventional medicine. We analysed trials of homoeopathy and conventional medicine and estimated treatment effects in trials least likely to be affected by bias. Placebo-controlled trials of homoeopathy were identified by a comprehensive literature search, which covered 19 electronic databases, reference lists of relevant papers, and contacts with experts. Trials in conventional medicine matched to homoeopathy trials for disorder and type of outcome were randomly selected from the Cochrane Controlled Trials Register (issue 1, 2003). Data were extracted in duplicate and outcomes coded so that odds ratios below 1 indicated benefit. Trials described as double-blind, with adequate randomisation, were assumed to be of higher methodological quality. Bias effects were examined in funnel plots and meta-regression models. 110 homoeopathy trials and 110 matched conventional-medicine trials were analysed. The median study size was 65 participants (range ten to 1573). 21 homoeopathy trials (19%) and nine (8%) conventional-medicine trials were of higher quality. In both groups, smaller trials and those of lower quality showed more beneficial treatment effects than larger and higher-quality trials. When the analysis was restricted to large trials of higher quality, the odds ratio was 0.88 (95% CI 0.65-1.19) for homoeopathy (eight trials) and 0.58 (0.39-0.85) for conventional medicine (six trials). Biases are present in placebo-controlled trials of both homoeopathy and conventional medicine. When account was taken for these biases in the analysis, there was weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions. This finding is compatible with the notion that the clinical effects of

Research Gaps in Wilderness Medicine.

PubMed

Tritz, Daniel; Dormire, Kody; Brachtenbach, Travis; Gordon, Joshua; Sanders, Donald; Gearheart, David; Crawford, Julia; Vassar, Matt

2018-05-18

Wilderness medicine involves the treatment of individuals in remote, austere environments. Given the high potential for injuries as well as the unique treatment modalities required in wilderness medicine, evidence-based clinical practice guidelines are necessary to provide optimal care. In this study, we identify evidence gaps from low-quality recommendations in wilderness medicine clinical practice guidelines and identify new/ongoing research addressing them. We included relevant clinical practice guidelines from the Wilderness Medical Society and obtained all 1C or 2C level recommendations. Patient/Problem/Population, intervention, comparison, outcome (PICO) questions were created to address each recommendation. Using 24 search strings, we extracted titles, clinical trial registry number, and recruitment status for 8899 articles. We categorized the articles by trial design to infer the effect they may have on future recommendations. Twelve clinical practice guidelines met inclusion criteria. From these we located 275 low-quality recommendations and used them to create 275 PICO questions. Thirty-three articles were relevant to the PICO questions. Heat-related illness had the highest number of relevant articles (n=9), but acute pain and altitude sickness had the most randomized clinical trials (n=6). Overall, few studies were being conducted to address research gaps in wilderness medicine. Heat-related illness had the most new or ongoing research, whereas no studies were being conducted to address gaps in eye injuries, basic wound management, or spine immobilization. Animals, cadavers, and mannequin research are useful in cases in which human evidence is difficult to obtain. Establishing research priorities is recommended for addressing research gaps identified by guideline panels. Copyright © 2018 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

Recent Advances in Traditional Chinese Medicine for Kidney Disease.

PubMed

Zhong, Yifei; Menon, Madhav C; Deng, Yueyi; Chen, Yiping; He, John Cijiang

2015-09-01

Because current treatment options for chronic kidney disease (CKD) are limited, many patients seek out alternative therapies such as traditional Chinese medicine. However, there is a lack of evidence from large clinical trials to support the use of traditional medicines in patients with CKD. Many active components of traditional medicine formulas are undetermined and their toxicities are unknown. Therefore, there is a need for research to identify active compounds from traditional medicines and understand the mechanisms of action of these compounds, as well as their potential toxicity, and subsequently perform well-designed, randomized, controlled, clinical trials to study the efficacy and safety of their use in patients with CKD. Significant progress has been made in this field within the last several years. Many active compounds have been identified by applying sophisticated techniques such as mass spectrometry, and more mechanistic studies of these compounds have been performed using both in vitro and in vivo models. In addition, several well-designed, large, randomized, clinical trials have recently been published. We summarize these recent advances in the field of traditional medicines as they apply to CKD. In addition, current barriers for further research are also discussed. Due to the ongoing research in this field, we believe that stronger evidence to support the use of traditional medicines for CKD will emerge in the near future. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

The quality of reporting of randomized controlled trials of traditional Chinese medicine: a survey of 13 randomly selected journals from mainland China.

PubMed

Wang, Gang; Mao, Bing; Xiong, Ze-Yu; Fan, Tao; Chen, Xiao-Dong; Wang, Lei; Liu, Guan-Jian; Liu, Jia; Guo, Jia; Chang, Jing; Wu, Tai-Xiang; Li, Ting-Qian

2007-07-01

The number of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) is increasing. However, there have been few systematic assessments of the quality of reporting of these trials. This study was undertaken to evaluate the quality of reporting of RCTs in TCM journals published in mainland China from 1999 to 2004. Thirteen TCM journals were randomly selected by stratified sampling of the approximately 100 TCM journals published in mainland China. All issues of the selected journals published from 1999 to 2004 were hand-searched according to guidelines from the Cochrane Centre. All reviewers underwent training in the evaluation of RCTs at the Chinese Centre of Evidence-based Medicine. A comprehensive quality assessment of each RCT was completed using a modified version of the Consolidated Standards of Reporting Trials (CONSORT) checklist (total of 30 items) and the Jadad scale. Disagreements were resolved by consensus. Seven thousand four hundred twenty-two RCTs were identified. The proportion of published RCTs relative to all types of published clinical trials increased significantly over the period studied, from 18.6% in 1999 to 35.9% in 2004 (P < 0.001). The mean (SD) Jadad score was 1.03 (0.61) overall. One RCT had a Jadad score of 5 points; 14 had a score of 4 points; and 102 had a score of 3 points. The mean (SD) Jadad score was 0.85 (0.53) in 1999 (746 RCTs) and 1.20 (0.62) in 2004 (1634 RCTs). Across all trials, 39.4% of the items on the modified CONSORT checklist were reported, which was equivalent to 11.82 (5.78) of the 30 items. Some important methodologic components of RCTs were incompletely reported, such as sample-size calculation (reported in 1.1% of RCTs), randomization sequence (7.9%), allocation concealment (0.3 %), implementation of the random-allocation sequence (0%), and analysis of intention to treat (0%). The findings of this study indicate that the quality of reporting of RCTs of TCM has improved, but remains poor.

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)

M-V launch vehicle

NASA Astrophysics Data System (ADS)

Matsuo, Hiroki; Kawaguchi, Jun'ichiro

1995-01-01

M-V is the next generation satellite launcher of the Institute of Space and Astronautical Science (IS AS) expected to be a work horse for Japanese scientific missions beyond late 1990s. It is a three staged, solid propellant rocket with 2ton class launch capability into LEO. Its development is underway toward the revised first launch date in 1996. This paper describes the back ground and the design philosophy of M-V along with vehicle characteristics featuring new technology to be introduced. Also given are the development status and the launch schedule.

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…

The History of "Exercise Is Medicine" in Ancient Civilizations

ERIC Educational Resources Information Center

Tipton, Charles M.

2014-01-01

In 2007, the American College of Sports Medicine, with endorsement from the American Medical Association and the Office of the Surgeon General, launched a global initiative to mobilize physicians, healthcare professionals and providers, and educators to promote exercise in their practice or activities to prevent, reduce, manage, or treat diseases…

Effects of a Herbal Medicine, Yukgunja-Tang, on Functional Dyspepsia Patients Classified by 3-Dimensional Facial Measurement: A Study Protocol for Placebo-Controlled, Double-Blind, Randomized Trial.

PubMed

Kim, Juyeon; Park, Jae-Woo; Ko, Seok-Jae; Jeon, Soo-Hyung; Kim, Jong-Won; Yeo, Inkwon; Kim, Jinsung

2017-01-01

Introduction . Functional dyspepsia (FD), a common upper gastrointestinal disease, is difficult to manage because of the limitations of current conventional treatments. Yukgunja-tang (YGJT) is widely used to treat FD in clinical practice in Korea, Japan, and China. However, YGJT significantly improves few symptoms of FD. In Korean medicine, FD is a well-known functional gastric disease that shows difference in the effect of herbal medicine depending on constitution or type of Korean medicine diagnosis. This study aims to investigate the efficacy of YGJT on FD patients classified by 3-dimensional facial measurement using a 3-dimensional facial shape diagnostic system (3-FSDS). Methods . A placebo-controlled, double-blind, randomized, two-center trial will be performed to evaluate the efficacy of YGJT on FD patients. Eligible subjects will be initially classified as two types by 3-dimensional facial measurement using the 3-FSDS. Ninety-six subjects (48 subjects per each type) will be enrolled. These subjects will be randomly allocated into treatment or control groups in a 2 : 1 ratio. YGJT or placebo will be administered to each group during the 8-week treatment period. The primary outcome is total dyspepsia symptom scale, and the secondary outcomes include single dyspepsia symptom scale, proportion of responders with adequate symptom relief, visual analog scale, Nepean dyspepsia index-Korean version, functional dyspepsia-related quality of life, and spleen qi deficiency questionnaire. Discussion . This is the first randomized controlled trial to assess the efficacy of the YGJT on FD patients classified by 3-dimensional facial measurement. We will compare the treatment effect of the YGJT on FD patients classified as two types using the 3-FSDS. The results of this trial will help the FD patients improve the symptoms and quality of life effectively and provide objective evidence for prescribing the YGJT to FD patients in clinical practice. Trial Registration . This

Efficacy of Chinese herbal medicine Zengru Gao to promote breastfeeding: a multicenter randomized controlled trial.

PubMed

Wang, Shuaishuai; Zhang, Chi; Li, Cuishan; Li, Daocheng; He, Ping; Su, Zhaojuan; Li, Yanling; Ding, Yiling; Lu, Aiping

2018-02-06

Breastfeeding is recommended worldwide but not fully practiced. The first week after childbirth is regarded as a critical period for increasing breast milk production. The aim of the study was to investigate whether Chinese herbal medicine Zengru Gao would result in more women breastfeeding in the first week after childbirth. A multicenter randomized controlled trial was conducted of 588 mothers considering breastfeeding in China. Among the mothers of the intervention group, the intervention included Chinese herbal medicine Zengru Gao; among those of the control group, it did not. Primary outcomes were the percentages of fully and partially breastfeeding mothers. Secondary outcome was baby's daily formula intake. At 3 d and 7 d after delivery, significant differences were found in favour of Zengru Gao group on the percentage of full/ partial breastfeeding (Z = - 3.0037, p = 0.0027). At day 7, the percentage of full/ partial breastfeeding of the active group increased to 71.48%/20.70% versus 58.67%/30.26% in the control group, the differences remained significant (Z = - 3.0037, p = 0.0027). No statistically significant differences were detected on primary measures at 1 d. While intake of formula differed between groups at 1 d and 3 d, this difference did not achieve statistical significance, but this difference was apparent by 7 d (55.45 ± 115.39 ml/day vs 90.66 ± 153.89 ml/day). In conclusion, Chinese Herbal medicine Zengru Gao enhanced breastfeeding success during one week postpartum. The approach is acceptable to participants and merits further evaluation. ChiCTR-IPR-15007376 , December 11, 2015.

Comparison of current Shuttle and pre-Challenger flight suit reach capability during launch accelerations

NASA Technical Reports Server (NTRS)

Bagian, James P.; Schafer, Lauren E.

1992-01-01

The Challenger accident prompted the creation of a crew escape system which replaced the former Launch Entry Helmet (LEH) ensemble with the current Launch Entry Suit (LES). However, questions were raised regarding the impact of this change on crew reach capability. This study addressed the question of reach capability and its effects on realistic ground-based training for Space Shuttle missions. Eleven subjects performed reach sweeps in both the LEH and LES suits during 1 and 3 Gx acceleration trials in the Brooks AFB centrifuge. These reach sweeps were recorded on videotape and subsequently analyzed using a 3D motion analysis system. The ANOVA procedure of the Statistical Analysis System program was used to evaluate differences in forward and overhead reach. The results showed that the LES provided less reach capability than its predecessor, the LEH. This study also demonstrated that, since there was no substantial difference between 1 and 3 Gx reach sweeps in the LES, realistic Shuttle launch training may be accomplished in ground based simulators.

Constellation Ground Systems Launch Availability Analysis: Enhancing Highly Reliable Launch Systems Design

NASA Technical Reports Server (NTRS)

Gernand, Jeffrey L.; Gillespie, Amanda M.; Monaghan, Mark W.; Cummings, Nicholas H.

2010-01-01

Success of the Constellation Program's lunar architecture requires successfully launching two vehicles, Ares I/Orion and Ares V/Altair, within a very limited time period. The reliability and maintainability of flight vehicles and ground systems must deliver a high probability of successfully launching the second vehicle in order to avoid wasting the on-orbit asset launched by the first vehicle. The Ground Operations Project determined which ground subsystems had the potential to affect the probability of the second launch and allocated quantitative availability requirements to these subsystems. The Ground Operations Project also developed a methodology to estimate subsystem reliability, availability, and maintainability to ensure that ground subsystems complied with allocated launch availability and maintainability requirements. The verification analysis developed quantitative estimates of subsystem availability based on design documentation, testing results, and other information. Where appropriate, actual performance history was used to calculate failure rates for legacy subsystems or comparative components that will support Constellation. The results of the verification analysis will be used to assess compliance with requirements and to highlight design or performance shortcomings for further decision making. This case study will discuss the subsystem requirements allocation process, describe the ground systems methodology for completing quantitative reliability, availability, and maintainability analysis, and present findings and observation based on analysis leading to the Ground Operations Project Preliminary Design Review milestone.

Near-term Horizontal Launch for Flexible Operations: Results of the DARPA/NASA Horizontal Launch Study

NASA Technical Reports Server (NTRS)

Bartolotta, Paul A.; Wilhite, Alan W.; Schaffer, Mark G.; Huebner, Lawrence D.; Voland, Randall T.; Voracek, David F.

2012-01-01

Horizontal launch has been investigated for 60 years by over 130 different studies. During this time only one concept, Pegasus, has ever been in operation. The attractiveness of horizontal launch is the capability to provide a "mobile launch pad" that can use existing aircraft runways, cruise above weather, loiter for mission instructions, and provide precise placement for orbital intercept, rendezvous, or reconnaissance. A jointly sponsored study by DARPA and NASA, completed in 2011, explored the trade space of horizontal launch system concepts which included an exhaustive literature review of the past 70 years. The Horizontal Launch Study identified potential near- and mid-term concepts capable of delivering 15,000 lb payloads to a 28.5 due East inclination, 100 nautical-mile low-Earth orbit. Results are presented for a range of near-term system concepts selected for their availability and relatively low design, development, test, and evaluation (DDT&E) costs. This study identified a viable low-cost development path forward to make a robust and resilient horizontal launch capability a reality.

Commercial space and launch insurance : current market and future outlook : fourth quarter 2002 Quarterly Launch Report

DOT National Transportation Integrated Search

2002-01-01

Since the last review of the space and launch insurance industry (see "Update of the Space and Launch Insurance Industry," 4th quarter, : 1998 Quarterly Launch Report), many changes have occurred in the market. This report endeavors to examine the cu...

Intelsat communications satellite scheduled for launch

NASA Technical Reports Server (NTRS)

1983-01-01

To be placed into a highly elliptical transfer orbit by the Atlas Centaur (AC-61) launch vehicle, the INTELSAT V-F satellite has 12,000 voice circuits and 2 color television channels and incorporates a maritime communication system for ship to shore communications. The stages of the launch vehicle and the launch operations are described. A table shows the launch sequence.

Athena: Advanced air launched space booster

NASA Astrophysics Data System (ADS)

Booker, Corey G.; Ziemer, John; Plonka, John; Henderson, Scott; Copioli, Paul; Reese, Charles; Ullman, Christopher; Frank, Jeremy; Breslauer, Alan; Patonis, Hristos

1994-06-01

The infrastructure for routine, reliable, and inexpensive access of space is a goal that has been actively pursued over the past 50 years, but has yet not been realized. Current launch systems utilize ground launching facilities which require the booster vehicle to plow up through the dense lower atmosphere before reaching space. An air launched system on the other hand has the advantage of being launched from a carrier aircraft above this dense portion of the atmosphere and hence can be smaller and lighter compared to its ground based counterpart. The goal of last year's Aerospace Engineering Course 483 (AE 483) was to design a 227,272 kg (500,000 lb.) air launched space booster which would beat the customer's launch cost on existing launch vehicles by at least 50 percent. While the cost analysis conducted by the class showed that this goal could be met, the cost and size of the carrier aircraft make it appear dubious that any private company would be willing to invest in such a project. To avoid this potential pitfall, this year's AE 483 class was to design as large an air launched space booster as possible which can be launched from an existing or modification to an existing aircraft. An initial estimate of the weight of the booster is 136,363 kg (300,000 lb.) to 159,091 kg (350,000 lb.).

Athena: Advanced air launched space booster

NASA Technical Reports Server (NTRS)

Booker, Corey G.; Ziemer, John; Plonka, John; Henderson, Scott; Copioli, Paul; Reese, Charles; Ullman, Christopher; Frank, Jeremy; Breslauer, Alan; Patonis, Hristos

1994-01-01

The infrastructure for routine, reliable, and inexpensive access of space is a goal that has been actively pursued over the past 50 years, but has yet not been realized. Current launch systems utilize ground launching facilities which require the booster vehicle to plow up through the dense lower atmosphere before reaching space. An air launched system on the other hand has the advantage of being launched from a carrier aircraft above this dense portion of the atmosphere and hence can be smaller and lighter compared to its ground based counterpart. The goal of last year's Aerospace Engineering Course 483 (AE 483) was to design a 227,272 kg (500,000 lb.) air launched space booster which would beat the customer's launch cost on existing launch vehicles by at least 50 percent. While the cost analysis conducted by the class showed that this goal could be met, the cost and size of the carrier aircraft make it appear dubious that any private company would be willing to invest in such a project. To avoid this potential pitfall, this year's AE 483 class was to design as large an air launched space booster as possible which can be launched from an existing or modification to an existing aircraft. An initial estimate of the weight of the booster is 136,363 kg (300,000 lb.) to 159,091 kg (350,000 lb.).

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

PubMed Central

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

2015-01-01

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

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

PubMed

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

2015-01-01

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

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.

Magnetic Launch Assist Experimental Track

NASA Technical Reports Server (NTRS)

1999-01-01

In this photograph, a futuristic spacecraft model sits atop a carrier on the Magnetic Launch Assist System, formerly known as the Magnetic Levitation (MagLev) System, experimental track at the Marshall Space Flight Center (MSFC). Engineers at MSFC have developed and tested Magnetic Launch Assist technologies that would use magnetic fields to levitate and accelerate a vehicle along a track at very high speeds. Similar to high-speed trains and roller coasters that use high-strength magnets to lift and propel a vehicle a couple of inches above a guideway, a Magnetic Launch Assist system would electromagnetically drive a space vehicle along the track. A full-scale, operational track would be about 1.5-miles long and capable of accelerating a vehicle to 600 mph in 9.5 seconds. This track is an advanced linear induction motor. Induction motors are common in fans, power drills, and sewing machines. Instead of spinning in a circular motion to turn a shaft or gears, a linear induction motor produces thrust in a straight line. Mounted on concrete pedestals, the track is 100-feet long, about 2-feet wide, and about 1.5-feet high. The major advantages of launch assist for NASA launch vehicles is that it reduces the weight of the take-off, the landing gear, the wing size, and less propellant resulting in significant cost savings. The US Navy and the British MOD (Ministry of Defense) are planning to use magnetic launch assist for their next generation aircraft carriers as the aircraft launch system. The US Army is considering using this technology for launching target drones for anti-aircraft training.

Effectiveness of acupuncture for angina pectoris: a systematic review of randomized controlled trials.

PubMed

Yu, Changhe; Ji, Kangshou; Cao, Huijuan; Wang, Ying; Jin, Hwang Hye; Zhang, Zhe; Yang, Guanlin

2015-03-28

The purpose of this systematic review is to assess the effectiveness of acupuncture for angina pectoris. Eleven electronic databases were searched until January 2013. The study included randomized controlled trials that the effectiveness of acupuncture alone was compared to anti-angina medicines (in addition to conventional treatment) and the effectiveness of a combination of acupuncture plus anti-angina medicines was compared to anti-angina medicines alone. The trial selection, data extraction, quality assessment and data analytic procedures outlined in the 2011 Cochrane Handbook were involved. The study included 25 randomized controlled trials (involving 2,058 patients) that met our inclusion criteria. The pooled results showed that the number of patients with ineffectiveness of angina relief was less in the combined acupuncture-anti-angina treatment group than in the anti-angina medicines alone group (RR 0.33, 95% CI 0.23-0.47, p < 0.00001, I2 = 0%). Similarly, compared to the anti-angina medicines alone group, fewer patients in the combined treatment group showed no ECG improvement (RR 0.50, 95% CI 0.40-0.62, p < 0.00001, I2 = 0%). However, no differences were observed between acupuncture treatment alone and anti-angina medicines alone for both outcome measures. Only four trials mentioned adverse effects. One trial found no significant difference between acupuncture and Chinese medicine, and three reported no adverse events. The quality of the trials was found to be low. The findings showed very low evidence to support the use of acupuncture for improving angina symptoms and ECG of angina patients. However, the quality of the trials included in this study was low. Large and rigorously designed trials are needed to confirm the potential benefit and adverse events of acupuncture.

Taking the Next Steps: The Ares I Crew Launch Vehicle and Ares V Cargo Launch Vehicle

NASA Technical Reports Server (NTRS)

Cook, Stephen A.; Vanhooser, Teresa

2008-01-01

The National Aeronautics and Space Administration (NASA)'s Constellation Program is depending on the Ares Projects Office (APO) to deliver the crew and cargo launch capabilities needed to send human explorers to the Moon, Mars, and beyond. The APO continues to make progress toward design, component testing, and early flight testing of the Ares I crew launch vehicle, as well as early design work for the Ares V cargo launch vehicle. Ares I and Ares V will form the core space launch capabilities that the United States needs to continue its pioneering tradition as a spacefaring nation (Figure 1). This paper will discuss design, fabrication, and testing progress toward building these new launch vehicles.

No Launch Before Its Time

NASA Technical Reports Server (NTRS)

Townsend, Bill

2004-01-01

Aura is an Earth-observing satellite developed to help us study the quality of the air we breathe. It will look at the state of the ozone and the atmospheric composition in regards to the Earth's changing climate. I headed to California on July 5, 2004. The plan was that the satellite would launch on the tenth, but we had a few problems getting it off. This was the fifty-ninth launch of my career, and it was also a little different than most of my previous launches. Most of the time it's weather that postpones a launch; there aren't usually that many technical issues this late in the game. This time. however, we had several problems, equally split between the launch vehicle and the spacecraft. I remember a member of the crew asking me, 'Is this normal?' And in my experience, it wasn't.

High Altitude Launch for a Practical SSTO

NASA Technical Reports Server (NTRS)

Landis, Geoffrey A.; Denis, Vincent

2003-01-01

Existing engineering materials allow the construction of towers to heights of many kilometers. Orbital launch from a high altitude has significant advantages over sea-level launch due to the reduced atmospheric pressure, resulting in lower atmospheric drag on the vehicle and allowing higher rocket engine performance. High-altitude launch sites are particularly advantageous for single-stage to orbit (SSTO) vehicles, where the payload is typically 2 percent of the initial launch mass. An earlier paper enumerated some of the advantages of high altitude launch of SSTO vehicles. In this paper, we calculate launch trajectories for a candidate SSTO vehicle, and calculate the advantage of launch at launch altitudes 5 to 25 kilometer altitudes above sea level. The performance increase can be directly translated into increased payload capability to orbit, ranging from 5 to 20 percent increase in the mass to orbit. For a candidate vehicle with an initial payload fraction of 2 percent of gross lift-off weight, this corresponds to 31 percent increase in payload (for 5-kilometer launch altitude) to 122 percent additional payload (for 25-kilometer launch altitude).

High Altitude Launch for a Practical SSTO

NASA Technical Reports Server (NTRS)

Landis, Geoffrey A.; Denis, Vincent

2003-01-01

Existing engineering materials allow the construction of towers to heights of many kilometers. Orbital launch from a high altitude has significant advantages over sea-level launch due to the reduced atmospheric pressure, resulting in lower atmospheric drag on the vehicle and allowing higher rocket engine performance. high-altitude launch sites are particularly advantageous for single-stage to orbit (SSTO) vehicles, where the payload is typically 2% of the initial launch mass. An earlier paper enumerated some of the advantages of high altitude launch of SSTO vehicles. In this paper, we calculate launch trajectories for a candidate SSTO vehicle, and calculate the advantage of launch at launch altitudes 5 to 25 kilometer altitudes above sea level. The performance increase can be directly translated in to increased payload capability to orbit, ranging from 5 to 20% increase in the mass to orbit. For a candidate vehicle with an initial payload fraction of 2% of gross lift-off weight, this corresponds to 31 % increase in payload (for 5-km launch altitude) to 122% additional payload (for 25-km launch altitude).

High Altitude Launch for a Practical SSTO

NASA Technical Reports Server (NTRS)

Landis, Geoffrey A.; Denis, Vincent; Lyons, Valerie (Technical Monitor)

2003-01-01

Existing engineering materials allow the construction of towers to heights of many kilometers. Orbital launch from a high altitude has significant advantages over sea-level launch due to the reduced atmospheric pressure, resulting in lower atmospheric drag on the vehicle and allowing higher rocket engine performance. High-altitude launch sites are particularly advantageous for single-stage to orbit (SSTO) vehicles, where the payload is typically 2% of the initial launch mass. An earlier paper enumerated some of the advantages of high altitude launch of SSTO vehicles. In this paper, we calculate launch trajectories for a candidate SSTO vehicle, and calculate the advantage of launch at launch altitudes 5 to 25 kilometer altitudes above sea level. The performance increase can be directly translated into increased payload capability to orbit, ranging from 5 to 20% increase in the mass to orbit. For a candidate vehicle with an initial payload fraction of 2% of gross lift-off weight, this corresponds to 31% increase in payload (for 5-km launch altitude) to 122% additional payload (for 25-km launch altitude).

High Altitude Launch for a Practical SSTO

NASA Astrophysics Data System (ADS)

Landis, Geoffrey A.; Denis, Vincent

2003-01-01

Existing engineering materials allow the constuction of towers to heights of many kilometers. Orbital launch from a high altitude has significant advantages over sea-level launch due to the reduced atmospheric pressure, resulting in lower atmospheric drag on the vehicle and allowing higher rocket engine performance. High-altitude launch sites are particularly advantageous for single-stage to orbit (SSTO) vehicles, where the payload is typically 2% of the initial launch mass. An earlier paper enumerated some of the advantages of high altitude launch of SSTO vehicles. In this paper, we calculate launch trajectories for a candidate SSTO vehicle, and calculate the advantage of launch at launch altitudes 5 to 25 kilometer altitudes above sea level. The performance increase can be directly translated into increased payload capability to orbit, ranging from 5 to 20% increase in the mass to orbit. For a candidate vehicle with an initial payload fraction of 2% of gross lift-off weight, this corresponds to 31% increase in payload (for 5-km launch altitude) to 122% additional payload (for 25-km launch altitude).

Rocket Launch Trajectory Simulations Mechanism

NASA Technical Reports Server (NTRS)

Margasahayam, Ravi; Caimi, Raoul E.; Hauss, Sharon; Voska, N. (Technical Monitor)

2002-01-01

The design and development of a Trajectory Simulation Mechanism (TSM) for the Launch Systems Testbed (LST) is outlined. In addition to being one-of-a-kind facility in the world, TSM serves as a platform to study the interaction of rocket launch-induced environments and subsequent dynamic effects on the equipment and structures in the close vicinity of the launch pad. For the first time, researchers and academicians alike will be able to perform tests in a laboratory environment and assess the impact of vibroacoustic behavior of structures in a moving rocket scenario on ground equipment, launch vehicle, and its valuable payload or spacecraft.

ARES I-X Launch Prep

NASA Image and Video Library

2009-10-26

Mission managers, from left, NASA Ares I-X Assistant Launch Director Pete Nickolenko, Ground Operations Manager Philip "Pepper" Phillips, Ares I-X Launch Director Ed Mango, and Constellation Program manager Jeff Hanley review the latest weather radar from Firing Room One of the Launch Control Center (LCC) at the Kennedy Space Center during the launch countdown of the Ares I-X rocket in Cape Canaveral, Fla., Tuesday, Oct. 27, 2009. The flight test of Ares I-X will provide NASA with an early opportunity to test and prove flight characteristics, hardware, facilities and ground operations associated with the Ares I. Photo Credit: (NASA/Bill Ingalls)

Precision medicine needs pioneering clinical bioinformaticians.

PubMed

Gómez-López, Gonzalo; Dopazo, Joaquín; Cigudosa, Juan C; Valencia, Alfonso; Al-Shahrour, Fátima

2017-10-25

Success in precision medicine depends on accessing high-quality genetic and molecular data from large, well-annotated patient cohorts that couple biological samples to comprehensive clinical data, which in conjunction can lead to effective therapies. From such a scenario emerges the need for a new professional profile, an expert bioinformatician with training in clinical areas who can make sense of multi-omics data to improve therapeutic interventions in patients, and the design of optimized basket trials. In this review, we first describe the main policies and international initiatives that focus on precision medicine. Secondly, we review the currently ongoing clinical trials in precision medicine, introducing the concept of 'precision bioinformatics', and we describe current pioneering bioinformatics efforts aimed at implementing tools and computational infrastructures for precision medicine in health institutions around the world. Thirdly, we discuss the challenges related to the clinical training of bioinformaticians, and the urgent need for computational specialists capable of assimilating medical terminologies and protocols to address real clinical questions. We also propose some skills required to carry out common tasks in clinical bioinformatics and some tips for emergent groups. Finally, we explore the future perspectives and the challenges faced by precision medicine bioinformatics. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Launch of Jupiter-C/Explorer 1

NASA Technical Reports Server (NTRS)

1958-01-01

Launch of Jupiter-C/Explorer 1 at Cape Canaveral, Florida on January 31, 1958. After the Russian Sputnik 1 was launched in October 1957, the launching of an American satellite assumed much greater importance. After the Vanguard rocket exploded on the pad in December 1957, the ability to orbit a satellite became a matter of national prestige. On January 31, 1958, slightly more than four weeks after the launch of Sputnik.The ABMA (Army Ballistic Missile Agency) in Redstone Arsenal, Huntsville, Alabama, in cooperation with the Jet Propulsion Laboratory, launched a Jupiter from Cape Canaveral, Florida. The rocket consisted of a modified version of the Redstone rocket's first stage and two upper stages of clustered Baby Sergeant rockets developed by the Jet Propulsion Laboratory and later designated as Juno boosters for space launches

The effect of dimple error on the horizontal launch angle and side spin of the golf ball during putting.

PubMed

Richardson, Ashley K; Mitchell, Andrew C S; Hughes, Gerwyn

2017-02-01

This study aimed to examine the effect of the impact point on the golf ball on the horizontal launch angle and side spin during putting with a mechanical putting arm and human participants. Putts of 3.2 m were completed with a mechanical putting arm (four putter-ball combinations, total of 160 trials) and human participants (two putter-ball combinations, total of 337 trials). The centre of the dimple pattern (centroid) was located and the following variables were measured: distance and angle of the impact point from the centroid and surface area of the impact zone. Multiple regression analysis was conducted to identify whether impact variables had significant associations with ball roll variables, horizontal launch angle and side spin. Significant associations were identified between impact variables and horizontal launch angle with the mechanical putting arm but this was not replicated with human participants. The variability caused by "dimple error" was minimal with the mechanical putting arm and not evident with human participants. Differences between the mechanical putting arm and human participants may be due to the way impulse is imparted on the ball. Therefore it is concluded that variability of impact point on the golf ball has a minimal effect on putting performance.

Environmentally-Preferable Launch Coatings

NASA Technical Reports Server (NTRS)

Kessel, Kurt R.

2015-01-01

The Ground Systems Development and Operations (GSDO) Program at NASA Kennedy Space Center (KSC), Florida, has the primary objective of modernizing and transforming the launch and range complex at KSC to benefit current and future NASA programs along with other emerging users. Described as the launch support and infrastructure modernization program in the NASA Authorization Act of 2010, the GSDO Program will develop and implement shared infrastructure and process improvements to provide more flexible, affordable, and responsive capabilities to a multi-user community. In support of NASA and the GSDO Program, the objective of this project is to determine the feasibility of environmentally friendly corrosion protecting coatings for launch facilities and ground support equipment (GSE). The focus of the project is corrosion resistance and survivability with the goal to reduce the amount of maintenance required to preserve the performance of launch facilities while reducing mission risk. The project compares coating performance of the selected alternatives to existing coating systems or standards.

Chinese herbal medicine for Henoch-Schönlein purpura in children without renal damage: a systematic review of randomized controlled trials.

PubMed

Yang, Ying; Wang, Congcong; Li, Xinxue; Chai, Qianyun; Fei, Yutong; Xia, Ruyu; Xu, Rongqian; Yang, Li; Liu, Jianping

2015-10-01

Henoch-Schönlein Purpura (HSP) is the most common necrotizing vasculitis affecting children. Traditional Chinese herbal medicine (CHM) was widely used. We aim to explore the evidence of effectiveness and safety of CHM for HSP in children without renal damage. Randomized controlled trials (RCTs) comparing CHM with conventional medications were searched from five databases. Eligible data were pooled using random-effects model using RevMan 5.2 Subgroup analysis for different co-interventions and sensitivity analysis for reducing heterogeneity were implemented. GRADE approach was adopted. We included 15 trials with 1112HSP children (age 1-16 years old), disease duration one day to three months. The overall methodological quality of included trials is relatively low. Adjunctive oral CHM treatments reduced renal damage (6 trials, RR 0.47, 95%CI 0.31-0.72, I(2)=0%), and subsiding time (days) of purpura (5 trials, mean difference (MD) -3.60, 95%CI -4.21 to -2.99, I(2)=23%), joint pain (5 trials, MD -1.04, 95%CI -1.33 to -0.74, I(2)=1%) and abdomen pain (5 trials, MD -1.69, 95%CI -2.51 to -0.86, I(2)=74%). Subgroup and sensitivity analysis did not change the direction of results. No severe adverse events reported. Orally taken adjunctive CHM treatments are effective for children suffering HSP in terms of reducing renal damage and subsiding time of purpura, and could possibly reduce subsiding pain of joint and abdomen. No reliable conclusion regarding safety is possible based on the safety data retrieved. Further rigorous trials are warranted. Copyright © 2015. Published by Elsevier Ltd.

Ethical quandaries in spiritual healing and herbal medicine: A critical analysis of the morality of traditional medicine advertising in southern African urban societies

PubMed Central

Munyaradzi, Mawere

2011-01-01

This paper critically examines the morality of advertising by practitioners in spiritual healing and herbal medicine heretofore referred to as traditional medicine, in southern African urban societies. While the subject of traditional medicine has been heavily contested in medical studies in the last few decades, the monumental studies on the subject have emphasised the place of traditional medicine in basic health services. Insignificant attention has been devoted to examine the ethical problems associated with traditional medicine advertising. Critical look at the worthiness of some advertising strategies used by practitioners in traditional medicine in launching their products and services on market thus has been largely ignored. Yet, though advertising is key to helping traditional medicine practitioners’ products and services known by prospective customers, this research registers a number of morally negative effects that seem to outweigh the merits that the activity brings to prospective customers. The paper adopts southern African urban societies, and in particular Mozambique, South Africa and Zimbabwe as particular references. The choice of the trio is not accidental, but based on the fact that these countries have in the last few decades been flooded with traditional medicine practitioners/traditional healers from within the continent and from abroad. Most of these practitioners use immoral advertising strategies in communicating to the public the products and services they offer. It is against this background that this paper examines the morality of advertising strategies deployed by practitioners in launching their products and services. To examine the moral worthiness of the advertising strategies used by traditional medical practitioners, I used qualitative analysis of street adverts as well as electronic and print media. From the results obtained through thematic content analysis, the paper concludes that most of the practitioners in traditional

A Quantitative Assessment of the Reporting Quality of Herbal Medicine Research: The Road to Improvement.

PubMed

Naumann, Ken

2018-02-01

To quantify different aspects of the quality of reporting of herbal medicine clinical trials, to determine how that quality is affecting the conclusions of meta-analyses, and to target areas for improvement in future herbal medicine research reporting. The Electronic databases PubMed, Academic Search Premier, ScienceDirect, and Alt HealthWatch were searched for meta-analyses of herbal medicines in refereed journals and Cochrane Reviews in the years 2000-2004 and 2010-2014. The search was limited to meta-analyses of randomized controlled trials involving humans and published in English. Judgments and descriptions within the meta-analyses were used to report on risks of bias in the included clinical trials and the meta-analyses themselves. Out of 3264 citations, 9 journal-published meta-analyses were selected from 2000 to 2004, 116 from 2010 to 2014, and 44 Cochrane Reviews from 2010 to 2014. Across both time frames and categories of publication, <42% of the trials included in the meta-analyses described adequate randomization; <19% described concealment methods; <26% described double blinding; <29% described outcome assessment blinding, ≤53% discussed incomplete data, and <36% were nonselective in their reporting. Less than 54% of trials reported on adverse events and 64% of meta-analyses did not include a single trial with a low risk of bias. Taxonomic verification and chemical characterization of test products were infrequent in trials. Only 40% of meta-analyses considered publication bias and, of those that did, 90% found evidence for it. Cochrane Reviews were more likely than other sources to make negative conclusions of efficacy or to defer conclusions because of the absence of high quality trials. Meta-analyses of herbal medicines include a significant number of clinical trials that do not meet the recommended standards for clinical trial reporting. This quantitative assessment identified significant publication bias and other bias risks that may be due to

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. The launch vehicle's first stage is a single, five-segment reusable solid rocket booster derived from the Space Shuttle Program's reusable solid rocket motor that burns a specially formulated and shaped solid propellant called polybutadiene acrylonitrile (PBAN). The second or upper stage will be propelled by a J-2X main engine fueled with liquid oxygen and liquid hydrogen. This HD video image depicts a test firing of a 40k subscale J2X injector at MSFC's test stand 115. (Highest resolution available)

Pragmatic clinical trials: ethical imperatives and opportunities.

PubMed

Kalkman, Shona; van Thiel, Ghislaine J M W; Grobbee, Diederick E; van Delden, Johannes J M

2018-06-12

Pragmatic clinical trials generate robust real-world evidence that holds great potential to better inform decision making regarding new medicines. For clinicians, patients and regulators, this evidence would preferably be available sooner rather than later. This means that, ideally, market authorization of any given medicine is accompanied by evidence obtained from a pragmatic trial. Given the operational and regulatory complexities of pragmatic trials in general, stakeholders tend to be hesitant to employ more pragmatism at the time of market approval. One prominent hurdle for the conduct of pragmatic trials is the concern that pragmatic design features conflict with ethical standards for clinical trials. To encourage timely yet responsible generation of real-world evidence through clinical trials, it is important to delineate exactly which areas, from a societal point of view, demand early pragmatic evaluations. We also urge stakeholders to recognize how the current system of trial ethics oversight already accommodates for more-pragmatic approaches, and how new ideas about their permissibility have progressed in the bioethics literature. Copyright © 2018. Published by Elsevier Ltd.

Comparison between herbal medicine and fluoxetine for depression: a systematic review of randomized controlled trials.

PubMed

Ren, Yi; Zhu, Chenjun; Wu, Jianjun; Zheng, Ruwen; Cao, Huijaun

2015-10-01

To evaluate the effectiveness and safety of Chinese herbal medicine (CHM) versus fluoxetine on depression. A systematic review of randomized controlled trials (RCTs). RCT with two parallel groups that compared CHM and fluoxetine on treatment of depression with reported decreased Hamilton Depression Scale (HAMD) and adverse events during treatment were included after searching through six electric-databases. The methodological quality of RCTs was assessed according to the Cochrane risk of bias tool. Meta-analysis was conducted using RevMan 5.3 software with pooled mean difference (MD) or risk ratio (RR) and their 95% confidence interval (CI) if no significant heterogeneity was detected. A SOF table was generated using GRADEPro software to evaluate the overall quality of the evidence. Twenty-six trials with 3294 participants were included in the review. Most of them had high risk of bias during conducting and reporting. The results achieved weak evidence which showed CHM had similar effect to fluoxetine (20mg/day) on relieving depression according to HAMD assessment (for primary depression: MD=-0.08, 95%CI -0.98-0.82; for secondary depression: MD=-0.36, 95%CI -1.55-0.83), but fewer incidences of adverse events than the drug (for primary depression: RR=0.31, 95%CI 0.17-0.59; for post-stroke depression: RR=0.04, 95%CI 0.00-0.25). No serious adverse event was found in neither CHM nor fluoxetine group. Due to the poor quality of included trials and the potential publication bias of this review, no confirmed conclusion could be draw to evaluate the effectiveness and safety of CHM for depression compared with fluoxetine. Copyright © 2015 Elsevier Ltd. All rights reserved.

Mobile, high-wind, balloon-launching apparatus

NASA Technical Reports Server (NTRS)

Rust, W. David; Marshall, Thomas C.

1989-01-01

In order to place instruments for measuring meteorological and electrical parameters into thunderstorms, an inexpensive apparatus has been developed which makes it possible to inflate, transport, and launch balloons in high winds. The launching apparatus is a cylinder of bubble plastic that is made by joining the sides of the cylinder together with a velcro rip strip. A balloon is launched by pulling the rip strip rapidly. This allows the balloon to pop upward into the ambient low-level wind and carry its instrumentation aloft. Different-sized launch tubes are constructed to accommodate particular sizes of balloons. Balloons have been launched in winds of about 20 m/s.

Consumer input into research: the Australian Cancer Trials website.

PubMed

Dear, Rachel F; Barratt, Alexandra L; Crossing, Sally; Butow, Phyllis N; Hanson, Susan; Tattersall, Martin Hn

2011-06-26

The Australian Cancer Trials website (ACTO) was publicly launched in 2010 to help people search for cancer clinical trials recruiting in Australia, provide information about clinical trials and assist with doctor-patient communication about trials. We describe consumer involvement in the design and development of ACTO and report our preliminary patient evaluation of the website. Consumers, led by Cancer Voices NSW, provided the impetus to develop the website. Consumer representative groups were consulted by the research team during the design and development of ACTO which combines a search engine, trial details, general information about trial participation and question prompt lists. Website use was analysed. A patient evaluation questionnaire was completed at one hospital, one week after exposure to the website. ACTO's main features and content reflect consumer input. In February 2011, it covered 1, 042 cancer trials. Since ACTO's public launch in November 2010, until the end of February 2011, the website has had 2, 549 new visits and generated 17, 833 page views. In a sub-study of 47 patient users, 89% found the website helpful for learning about clinical trials and all respondents thought patients should have access to ACTO. The development of ACTO is an example of consumers working with doctors, researchers and policy makers to improve the information available to people whose lives are affected by cancer and to help them participate in their treatment decisions, including consideration of clinical trial enrolment. Consumer input has ensured that the website is informative, targets consumer priorities and is user-friendly. ACTO serves as a model for other health conditions.

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)

Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy

PubMed Central

Jang, Soobin; Park, Sunju; Jang, Bo-Hyoung; Park, Yu Lee; Lee, Ju Ah; Cho, Chung-Sik; Go, Ho-Yeon; Shin, Yong Cheol; Ko, Seong-Gyu

2017-01-01

Introduction Nicotine dependence is a disease, and tobacco use is related to 6 million deaths annually worldwide. Recently, in many countries, there has been growing interest in the use of traditional and complementary medicine (T&CM) methods, especially acupuncture, as therapeutic interventions for smoking cessation. The aim of this pilot study is to investigate the effectiveness of T&CM interventions on smoking cessation. Methods and analysis The STOP (Stop Tobacco Programme using traditional Korean medicine) study is designed to be a pragmatic, open-label, randomised pilot trial. This trial will evaluate whether adding T&CM methods (ie, ear and body acupuncture, aromatherapy) to conventional cessation methods (ie, nicotine replacement therapy (NRT), counselling) increases smoking cessation rates. Forty participants over 19 years old who are capable of communicating in Korean will be recruited. They will be current smokers who meet one of the following criteria: (1) smoke more than 10 cigarettes a day, (2) smoke less than 10 cigarettes a day and previously failed to cease smoking, or (3) smoke fewer than 10 cigarettes a day and have a nicotine dependence score (Fagerstrom Test for Nicotine Dependence) of 4 points or more. The trial will consist of 4 weeks of treatment and a 20 week follow-up period. A statistician will perform the statistical analyses for both the intention-to-treat (all randomly assigned participants) and per-protocol (participants who completed the trial without any protocol deviations) data using SAS 9.1.3. Ethics and dissemination This study has been approved by the Institutional Review Board (IRB) of the Dunsan Korean Medicine Hospital of Daejeon University (IRB reference no: DJDSKH-15-BM-11–1, Protocol No. version 4.1.).The protocol will be reapproved by IRB if it requires amendment. The trial will be conducted according to the Declaration of Helsinki, 7th version (2013). This study is designed to minimise the risk to participants

Launch Commit Criteria Monitoring Agent

NASA Technical Reports Server (NTRS)

Semmel, Glenn S.; Davis, Steven R.; Leucht, Kurt W.; Rowe, Dan A.; Kelly, Andrew O.; Boeloeni, Ladislau

2005-01-01

The Spaceport Processing Systems Branch at NASA Kennedy Space Center has developed and deployed a software agent to monitor the Space Shuttle's ground processing telemetry stream. The application, the Launch Commit Criteria Monitoring Agent, increases situational awareness for system and hardware engineers during Shuttle launch countdown. The agent provides autonomous monitoring of the telemetry stream, automatically alerts system engineers when predefined criteria have been met, identifies limit warnings and violations of launch commit criteria, aids Shuttle engineers through troubleshooting procedures, and provides additional insight to verify appropriate troubleshooting of problems by contractors. The agent has successfully detected launch commit criteria warnings and violations on a simulated playback data stream. Efficiency and safety are improved through increased automation.

Trends in space launch services : globalization and commercial development : Quarterly Launch Report : special report

DOT National Transportation Integrated Search

1996-01-01

Launch service providers are leading the globalization of the space industry by forming international partnerships. The end of the Cold : War has created an environment that favors cooperation between manufacturers of high technology launch systems, ...

The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov.

PubMed

Chen, Junchao; Huang, Jihan; Li, Jordan V; Lv, Yinghua; He, Yingchun; Zheng, Qingshan

2017-01-01

The aim of this review is to characterize current status of global TCM clinical trials registered in ClinicalTrials.gov. We examined all the trials registered within ClinicalTrials.gov up to 25 September 2015, focusing on study interventions to identify TCM-related trials, and extracted 1,270 TCM trials from the data set. Overall, 691 (54.4%) trials were acupuncture, and 454 (35.8%) trials were herbal medicines. Differences in TCM trial intervention types were also evident among the specific therapeutic areas. Among all trials, 55.7% that were small studies enrolled <100 subjects, and only 8.7% of completed studies had reported results of trials. As for the location, the United States was second to China in conducting the most TCM trials. This review is the first snapshot of the landscape of TCM clinical trials registered in ClinicalTrials.gov, providing the basis for treatment and prevention of diseases within TCM and offering useful information that will guide future research on TCM.

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 CO 2 removal (ECCO 2 R) for ultraprotective ventilation in ARDS. ECCO 2 R 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 ECCO 2 R on driving pressure and mechanical power. This framework might enable prediction of individual treatment responses to ECCO 2 R. 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 ECCO 2 R on driving pressure and mortality in a preexisting cohort of patients with ARDS. Our computations suggest that restricting enrollment to patients in whom ECCO 2 R allows driving pressure to be decreased by 5 cm H 2 O 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.

Assessment of the Reporting Quality of Placebo-controlled Randomized Trials on the Treatment of Type 2 Diabetes With Traditional Chinese Medicine in Mainland China: A PRISMA-Compliant Systematic Review.

PubMed

Zhao, Xiyan; Zhen, Zhong; Guo, Jing; Zhao, Tianyu; Ye, Ru; Guo, Yu; Chen, Hongdong; Lian, Fengmei; Tong, Xiaolin

2016-01-01

Placebo-controlled randomized trials are often used to evaluate the absolute effect of new treatments and are considered gold standard for clinical trials. No studies, however, have yet been conducted evaluating the reporting quality of placebo-controlled randomized trials. The current study aims to assess the reporting quality of placebo-controlled randomized trials on treatment of diabetes with Traditional Chinese Medicine (TCM) in Mainland China and to provide recommendations for improvements.China National Knowledge Infrastructure database, Wanfang database, China Biology Medicine database, and VIP database were searched for placebo-controlled randomized trials on treatment of diabetes with TCM. Review, animal experiment, and randomized controlled trials without placebo control were excluded. According to Consolidated Standards of Reporting Trials (CONSORT) 2010 checklists items, each item was given a yes or no depending on whether it was reported or not.A total of 68 articles were included. The reporting percentage in each article ranged from 24.3% to 73%, and 30.9% articles reported more than 50% of the items. Seven of the 37 items were reported more than 90% of the items, whereas 7 items were not mentioned at all. The average reporting for "title and abstract," "introduction," "methods," "results," "discussion," and "other information" was 43.4%, 78.7%, 40.1%, 49.9%, 71.1%, and 17.2%, respectively. The percentage of each section had increased after 2010. In addition, the reporting of multiple study centers, funding, placebo species, informed consent forms, and ethical approvals were 14.7%, 50%, 36.85%, 33.8%, and 4.4%, respectively.Although a scoring system was created according to the CONSORT 2010 checklist, it was not designed as an assessment tool. According to CONSORT 2010, the reporting quality of placebo-controlled randomized trials on the treatment of diabetes with TCM improved after 2010. Future improvements, however, are still needed, particularly

Little Joe Launch

NASA Image and Video Library

1959-10-04

Launching of the LJ6 Little Joe on Oct. 4, 1959 took place at Wallops Island, Va. This was the first attempt to launch an instrumented capsule with a Little Joe booster. Only the LJ1A and the LJ6 used the space metal chevron plates as heat reflector shields, as they kept shattering. Caption title ...and ascending skyward on a plume of exhaust. Photograph published in Winds of Change, 75th Anniversary NASA publication, page 77, by James Schultz

Launch of STS-63 Discovery

NASA Technical Reports Server (NTRS)

1995-01-01

This wide lux image of the Space Shuttle Discovery as it began its race to catch up with Russia's Mir Space Station shows the base of the launch pad as well as the orbiter just clearing the gantry. Liftoff from Launch Pad 39B, Kennedy Space Center (KSC) occurred at 12:22:04 (EST) February 3, 1995. Discovery is the first in the current fleet of four space shuttle vehicles to make 20 launches.

Peer Review of Launch Environments

NASA Technical Reports Server (NTRS)

Wilson, Timmy R.

2011-01-01

Catastrophic failures of launch vehicles during launch and ascent are currently modeled using equivalent trinitrotoluene (TNT) estimates. This approach tends to over-predict the blast effect with subsequent impact to launch vehicle and crew escape requirements. Bangham Engineering, located in Huntsville, Alabama, assembled a less-conservative model based on historical failure and test data coupled with physical models and estimates. This white paper summarizes NESC's peer review of the Bangham analytical work completed to date.

Effect of Medicinal Herbs on Primary Dysmenorrhoea- a Systematic Review

PubMed Central

Mirabi, Parvaneh; Alamolhoda, Seideh Hanieh; Esmaeilzadeh, Seddigheh; Mojab, Faraz

2014-01-01

Conventional treatment for primary dysmenorrhoea has a failure rate of 20% to 25% and may be contraindicated or not tolerated by some women. Herbal medicine may be a suitable alternative. To determine the efficacy and safety of Iranian herbal medicine for primary dysmenorrhea when compared with placebo, no treatment, and other treatment. Electronic searches of the Cochrane Menstrual Disorders and Dysmenorrhoea Group Register of controlled trials, Scopus, Google Scholar, Medline, Pubmed were performed to identify relevant randomized controlled trials (RCTs). The study abstraction and quality assessment of all studies were undertaken following the detailed descriptions of these categories as described in the JADAD Criteria for Systematic Reviews of Interventions. 25 RCTs involving a total of women were included in the review. The review found promising evidence in the form of RCTs for the use of herbal medicine in the treatment of primary dysmenorrhoea compared with pharmacological treatment. However, the results were limited by methodological flaws. Further rigorous no penetrating placebo-controlled RCTs are warranted. The review found promising evidence supporting the use of herbal medicine for primary dysmenorrhoea; however, results are limited by the poor methodological quality of the included trials. PMID:25276177

Reusable Launch Vehicle Technology Program

NASA Technical Reports Server (NTRS)

Freeman, Delma C., Jr.; Talay, Theodore A.; Austin, R. Eugene

1996-01-01

Industry/NASA Reusable Launch Vehicle (RLV) Technology Program efforts are underway to design, test, and develop technologies and concepts for viable commercial launch systems that also satisfy national needs at acceptable recurring costs. Significant progress has been made in understanding the technical challenges of fully reusable launch systems and the accompanying management and operational approaches for achieving a low-cost program. This paper reviews the current status of the Reusable Launch Vehicle Technology Program including the DC-XA, X-33 and X-34 flight systems and associated technology programs. It addresses the specific technologies being tested that address the technical and operability challenges of reusable launch systems including reusable cryogenic propellant tanks, composite structures, thermal protection systems, improved propulsion, and subsystem operability enhancements. The recently concluded DC-XA test program demonstrated some of these technologies in ground and flight tests. Contracts were awarded recently for both the X-33 and X-34 flight demonstrator systems. The Orbital Sciences Corporation X-34 flight test vehicle will demonstrate an air-launched reusable vehicle capable of flight to speeds of Mach 8. The Lockheed-Martin X-33 flight test vehicle will expand the test envelope for critical technologies to flight speeds of Mach 15. A propulsion program to test the X-33 linear aerospike rocket engine using a NASA SR-71 high speed aircraft as a test bed is also discussed. The paper also describes the management and operational approaches that address the challenge of new cost-effective, reusable launch vehicle systems.

Health Is Primary: Family Medicine for America’s Health

PubMed Central

Phillips, Robert L.; Pugno, Perry A.; Saultz, John W.; Tuggy, Michael L.; Borkan, Jeffrey M.; Hoekzema, Grant S.; DeVoe, Jennifer E.; Weida, Jane A.; Peterson, Lars E.; Hughes, Lauren S.; Kruse, Jerry E.; Puffer, James C.

2014-01-01

PURPOSE More than a decade ago the American Academy of Family Physicians, American Academy of Family Physicians Foundation, American Board of Family Medicine, Association of Departments of Family Medicine, Association of Family Practice Residency Directors, North American Primary Care Research Group, and Society of Teachers of Family Medicine came together in the Future of Family Medicine (FFM) to launch a series of strategic efforts to “renew the specialty to meet the needs of people and society,” some of which bore important fruit. Family Medicine for America’s Health was launched in 2013 to revisit the role of family medicine in view of these changes and to position family medicine with new strategic and communication plans to create better health, better health care, and lower cost for patients and communities (the Triple Aim). METHODS Family Medicine for America’s Health was preceded and guided by the development of a family physician role definition. A consulting group facilitated systematic strategic plan development over 9 months that included key informant interviews, formal stakeholder surveys, future scenario testing, a retreat for family medicine organizations and stakeholder representatives to review strategy options, further strategy refinement, and finally a formal strategic plan with draft tactics and design for an implementation plan. A second communications consulting group surveyed diverse stakeholders in coordination with strategic planning to develop a communication plan. The American College of Osteopathic Family Physicians joined the effort, and students, residents, and young physicians were included. RESULTS The core strategies identified include working to ensure broad access to sustained, primary care relationships; accountability for increasing primary care value in terms of cost and quality; a commitment to helping reduce health care disparities; moving to comprehensive payment and away from fee-for-service; transformation of

CONSORT item reporting quality in the top ten ranked journals of critical care medicine in 2011: a retrospective analysis.

PubMed

Stevanovic, Ana; Schmitz, Sabine; Rossaint, Rolf; Schürholz, Tobias; Coburn, Mark

2015-01-01

Reporting randomised controlled trials is a key element in order to disseminate research findings. The CONSORT statement was introduced to improve the reporting quality. We assessed the adherence to the CONSORT statement of randomised controlled trials published 2011 in the top ten ranked journals of critical care medicine (ISI Web of Knowledge 2011, Thomson Reuters, London UK). Design. We performed a retrospective cross sectional data analysis. Setting. This study was executed at the University Hospital of RWTH, Aachen. Participants. We selected the following top ten listed journals according to ISI Web of Knowledge (Thomson Reuters, London, UK) critical care medicine ranking in the year 2011: American Journal of Respiratory and Critical Care Medicine, Critical Care Medicine, Intensive Care Medicine, CHEST, Critical Care, Journal of Neurotrauma, Resuscitation, Pediatric Critical Care Medicine, Shock and Minerva Anestesiologica. Main outcome measures. We screened the online table of contents of each included journal, to identify the randomised controlled trials. The adherence to the items of the CONSORT Checklist in each trial was evaluated. Additionally we correlated the citation frequency of the articles and the impact factor of the respective journal with the amount of reported items per trial. We analysed 119 randomised controlled trials and found, 15 years after the implementation of the CONSORT statement, that a median of 61,1% of the checklist-items were reported. Only 55.5% of the articles were identified as randomised trials in their titles. The citation frequency of the trials correlated significantly (rs = 0,433; p<0,001 and r = 0,331; p<0,001) to the CONSORT statement adherence. The impact factor showed also a significant correlation to the CONSORT adherence (r = 0,386; p<0,001). The reporting quality of randomised controlled trials in the field of critical care medicine remains poor and needs considerable improvement.

BMC Medicine celebrates its 5th anniversary

PubMed Central

Appleford, Joanne M; Cassady-Cain, Robin L; Patel, Jigisha; Norton, Melissa L

2009-01-01

In November 2008, BMC Medicine passed the landmark of its first 5 years of publishing. When we launched the journal with the aim of publishing high quality research of general interest and special importance, we had no idea what the future would bring. To mark the occasion of our 5th anniversary, we consider the achievements of the last 5 years and discuss our plans for the future.

Complementary, Alternative and Integrative Medicine for Childhood Atopic Dermatitis.

PubMed

Hon, Kam Lun; Leung, Alexander K C; Leung, Theresa N H; Lee, Vivian W Y

2017-01-01

Atopic Dermatitis (AD) is a chronic relapsing dermatosis associated with itch, sleep disturbance and poor quality of life. Treatment of AD includes the use of emollients, and topical and systemic immunomodulating agents. Many patients also use complementary and alternative medicine (CAM). This article reviews the pathophysiology of AD, clinical trials and recent patents involving various modalities of CAM in the treatment of AD. A Medline/Pubmed search was conducted using Clinical Queries with the key terms "Chinese Medicine OR Complementary and Alternative medicine" AND "Eczema OR Atopic dermatitis". The search strategy included meta-analyses, Randomized Controlled Trials (RCTs), clinical trials, reviews and pertinent references. Patents were searched using the key term "atopic dermatitis" from www.google.com/patents, www.uspto.gov, and www.freepatentsonline.com. Only a few RCTs evaluated the efficacy of Chinese medicinal herbs in treating AD. There was some evidence for other modalities of CAM. Integrative Medicine (IM) usually refers to the various forms of CAM that combine conventional western medicine and Chinese medicine. Supporting evidence for the efficacy of IM in the treatment of AD is presently lacking. Integration is difficult. Western medicine practitioners are often ignorant about CAM and IM. Parents are concerned about the potential side effects of Western medicine and will tend to be non-compliant with the conventional Western component of IM. Recent patents on CAM and IM are reviewed. Most CAM patents are herbal compositions, evidence on their efficacy is generally lacking. AD is a complex disease. The psychodynamics of the child and his/her family is the reason for the often suboptimal outcomes. Both Western and CAM practitioners should collaborate to create a mutually encouraging environment for the advances of IM. CAM and IM publications and patents are reviewed. Evidence of their efficacy is generally lacking. Further research is needed

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

PubMed

Homedes, Núria; Ugalde, Antonio

2015-10-01

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. 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. 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. 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.

EMEA and Gene Therapy Medicinal Products Development in the European Union

PubMed Central

2003-01-01

The evaluation of quality, safety, and efficacy of medicinal products by the European Medicines Evaluation Agency (EMEA) via the centralized procedure is the only available regulatory procedure for obtaining marketing authorization for gene therapy (GT) medicinal products in the European Union. The responsibility for the authorization of clinical trials remains with the national competent authorities (NCA) acting in a harmonized framework from the scientific viewpoint. With the entry into force of a new directive on good clinical practice implementation in clinical trials as of 1 May 2004, procedural aspects will also be harmonized at EU level. Scientifically sound development of medicinal products is the key for the successful registration of dossiers and for contributing to the promotion and protection of public health. The objective of this paper is to introduce the EMEA regulatory processes and scientific activities relevant to GT medicinal products. PMID:12686717

Importance of placebo effect in cough clinical trials.

PubMed

Eccles, Ron

2010-01-01

Cough is a unique symptom because, unlike sneeze and other symptoms, it can be under voluntary control and this complicates clinical trials on cough medicines. All over-the-counter cough medicines (OTC) are very effective treatments because of their placebo effect. The placebo effect is enhanced by expectancy related to advertising, brand, packaging, and formulation. This placebo effect creates a problem for the conduct of clinical trials on OTC cough medicines that attempt to demonstrate the efficacy of a pharmacological agent above that of any placebo effect. Up to 85% of the efficacy of some cough medicines can be attributed to a placebo effect. The placebo effect apparent in clinical trials consists of several components: natural recovery, regression of cough response toward mean, demulcent effect, effect of sweetness, voluntary control, and effects related to expectancy and meaning of the treatment. The placebo effect has been studied most in the pain model, and placebo analgesia is reported to depend on the activation of endogenous opioid systems in the brain; this model may be applicable to cough. A balanced placebo design may help to control for the placebo effect, but this trial design may not be acceptable due to deception of patients. The placebo effect in clinical trials may be controlled by use of a crossover design, where feasible, and the changes in the magnitude of the placebo effect in this study design are discussed.

The U.S. Evolved Expendable Launch Vehicle (EELV) programs : Quarterly Launch Report : special report

DOT National Transportation Integrated Search

1997-01-01

The Evolved Expendable Launch Vehicle (EELV) Program is a Department of Defense technology-development program managed by the Air Force. The program is intended to produce an improved launch vehicle family for government use. The EELV will replace th...

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

ISS Service Module Pre-Launch

NASA Technical Reports Server (NTRS)

2000-01-01

Various shots show Discovery at the launch pad during the final 30-minute countdown. The prelaunch conditions are described and information is given on the upcoming launch and the orbiter's docking with the International Space Station (ISS). A brief collage of rollout and launch footage of STS-92 Endeavour commemorates the 100th Space Shuttle mission and the 100th anniversary of the Philadelphia Orchestra (also seen). The music of '2001: A Space Odyssey) is played by the orchestra.

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)

LAUNCH - STS-1 - KSC

NASA Image and Video Library

1981-04-12

S81-30498 (12 April 1981) --- After six years of silence, the thunder of manned spaceflight is heard again, as the successful launch of the first space shuttle ushers in a new concept in utilization of space. The April 12, 1981 launch, at Pad 39A, just seconds past 7 a.m., carries astronaut John Young and Robert Crippen into an Earth-orbital mission scheduled to last for 54 hours, ending with unpowered landing at Edwards Air Force Base in California. STS-1, the first in a series of shuttle vehicles planned for the Space Transportation System, utilizes reusable launch and return components. Photo credit: NASA or National Aeronautics and Space Administration

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)

14 CFR 415.109 - Launch description.

Code of Federal Regulations, 2012 CFR

2012-01-01

...) Identification of any facilities at the launch site that will be used for launch processing and flight. (b... dimensions and weight; (iii) Location of all safety critical systems, including any flight termination hardware, tracking aids, or telemetry systems; (iv) Location of all major launch vehicle control systems...

14 CFR 415.109 - Launch description.

Code of Federal Regulations, 2013 CFR

2013-01-01

...) Identification of any facilities at the launch site that will be used for launch processing and flight. (b... dimensions and weight; (iii) Location of all safety critical systems, including any flight termination hardware, tracking aids, or telemetry systems; (iv) Location of all major launch vehicle control systems...

14 CFR 415.109 - Launch description.

Code of Federal Regulations, 2014 CFR

2014-01-01

...) Identification of any facilities at the launch site that will be used for launch processing and flight. (b... dimensions and weight; (iii) Location of all safety critical systems, including any flight termination hardware, tracking aids, or telemetry systems; (iv) Location of all major launch vehicle control systems...

Post Launch Monitoring of food products: what can be learned from pharmacovigilance.

PubMed

van Puijenbroek, E P; Hepburn, P A; Herd, T M; van Grootheest, A C

2007-03-01

Post Launch Monitoring (PLM) is one of the new approaches that are used in assessing the safety of novel foods or ingredients. It shares a close resemblance with procedures applied in the field of medicines, where Post Marketing Surveillance (PMS) has been carried out since the beginning of the 1960s. For this reason, Unilever and the Netherlands Pharmacovigilance Centre Lareb, maintaining the national reporting scheme in the Netherlands for adverse drug reactions, have been working together to optimize the Unilever's Post Launch Monitoring service. As a result of this cooperation a practical model for conducting PLM for food products has been developed. This model is also applicable for consumer products in general. The system allows for coding and assessing reports and the early detection of 'signals' of unintended health reactions. The methodological issues surrounding reporting of possible health reactions and practical issues surrounding coding and assessment of the reports that were encountered in the first period of this partnership are discussed. In addition, similarities and differences concerning PMS and PLM are described.

Launch Pad Flame Trench Refractory Materials

NASA Technical Reports Server (NTRS)

Calle, Luz M.; Hintze, Paul E.; Parlier, Christopher R.; Bucherl, Cori; Sampson, Jeffrey W.; Curran, Jerome P.; Kolody, Mark; Perusich, Steve; Whitten, Mary

2010-01-01

The launch complexes at NASA's John F. Kennedy Space Center (KSC) are critical support facilities for the successful launch of space-based vehicles. These facilities include a flame trench that bisects the pad at ground level. This trench includes a flame deflector system that consists of an inverted, V-shaped steel structure covered with a high temperature concrete material five inches thick that extends across the center of the flame trench. One side of the "V11 receives and deflects the flames from the orbiter main engines; the opposite side deflects the flames from the solid rocket boosters. There are also two movable deflectors at the top of the trench to provide additional protection to shuttle hardware from the solid rocket booster flames. These facilities are over 40 years old and are experiencing constant deterioration from launch heat/blast effects and environmental exposure. The refractory material currently used in launch pad flame deflectors has become susceptible to failure, resulting in large sections of the material breaking away from the steel base structure and creating high-speed projectiles during launch. These projectiles jeopardize the safety of the launch complex, crew, and vehicle. Post launch inspections have revealed that the number and frequency of repairs, as well as the area and size of the damage, is increasing with the number of launches. The Space Shuttle Program has accepted the extensive ground processing costs for post launch repair of damaged areas and investigations of future launch related failures for the remainder of the program. There currently are no long term solutions available for Constellation Program ground operations to address the poor performance and subsequent failures of the refractory materials. Over the last three years, significant liberation of refractory material in the flame trench and fire bricks along the adjacent trench walls following Space Shuttle launches have resulted in extensive investigations of

WESTAR-V launch on delta

NASA Technical Reports Server (NTRS)

1982-01-01

The WESTAR-V, the second in a series of second-generation, large, 24-transponder communications satellites developed for the Space Communications Company is discussed. It is scheduled to be launched on a Delta vehicle from the Eastern Space and Missile Center no earlier than June 8, 1982. The launch support for this mission will be provided by NASA, on a reimbursable basis, to the Space Communications Company for a fixed price of $25.OM. The launch vehicle for the WESTAR-V mission will be the Delta 3910 configuration which incorporates an extended long tank Thor booster, nine Castor IV strap-on motors, a TR-201 second stage, and an 8-foot fairing. The Delta launch vehicle will place the spacecraft along a suborbital trajectory. The PAM-D stage will then thrust it to a synchronous transfer orbit. Three days after launch, the spacecraft apogee kick motor will be fired to circularize its orbit at geosynchronous altitude of 19,300 NM above the equator at approxmately 75 degrees west longitude.

NASA's Space Launch System: Moving Toward the Launch Pad

NASA Technical Reports Server (NTRS)

Creech, Stephen D.; May, Todd A.

2013-01-01

The National Aeronautics and Space Administration's (NASA's) Space Launch System (SLS) Program, managed at the Marshall Space Flight Center (MSFC), is making progress toward delivering a new capability for human space flight and scientific missions beyond Earth orbit. Designed with the goals of safety, affordability, and sustainability in mind, the SLS rocket will launch the Orion Multi-Purpose Crew Vehicle (MPCV), equipment, supplies, and major science missions for exploration and discovery. Supporting Orion's first autonomous flight to lunar orbit and back in 2017 and its first crewed flight in 2021, the SLS will evolve into the most powerful launch vehicle ever flown via an upgrade approach that will provide building blocks for future space exploration. NASA is working to deliver this new capability in an austere economic climate, a fact that has inspired the SLS team to find innovative solutions to the challenges of designing, developing, fielding, and operating the largest rocket in history. This paper will summarize the planned capabilities of the vehicle, the progress the SLS Program has made in the 2 years since the Agency formally announced its architecture in September 2011, the path it is following to reach the launch pad in 2017 and then to evolve the 70 metric ton (t) initial lift capability to 130-t lift capability after 2021. The paper will explain how, to meet the challenge of a flat funding curve, an architecture was chosen that combines the use and enhancement of legacy systems and technology with strategic new developments that will evolve the launch vehicle's capabilities. This approach reduces the time and cost of delivering the initial 70 t Block 1 vehicle, and reduces the number of parallel development investments required to deliver the evolved 130 t Block 2 vehicle. The paper will outline the milestones the program has already reached, from developmental milestones such as the manufacture of the first flight hardware, to life

Space Launch System Spacecraft and Payload Elements: Making Progress Toward First Launch

NASA Technical Reports Server (NTRS)

Schorr, Andrew A.; Creech, Stephen D.; Ogles, Michael; Hitt, David

2016-01-01

Significant and substantial progress continues to be accomplished in the design, development, and testing of the Space Launch System (SLS), the most powerful human-rated launch vehicle the United States has ever undertaken. Designed to support human missions into deep space, SLS is one of three programs being managed by the National Aeronautics and Space Administration's (NASA's) Exploration Systems Development directorate. The Orion spacecraft program is developing a new crew vehicle that will support human missions beyond low Earth orbit, and the Ground Systems Development and Operations (GSDO) program is transforming Kennedy Space Center (KSC) into next-generation spaceport capable of supporting not only SLS but also multiple commercial users. Together, these systems will support human exploration missions into the proving ground of cislunar space and ultimately to Mars. SLS will deliver a near-term heavy-lift capability for the nation with its 70 metric ton Block 1 configuration, and will then evolve to an ultimate capability of 130 metric tons. The SLS program marked a major milestone with the successful completion of the Critical Design Review in which detailed designs were reviewed and subsequently approved for proceeding with full-scale production. This marks the first time an exploration class vehicle has passed that major milestone since the Saturn V vehicle launched astronauts in the 1960s during the Apollo program. Each element of the vehicle now has flight hardware in production in support of the initial flight of the SLS - Exploration Mission-1 (EM-1), an uncrewed mission to orbit the moon and return, and progress in on track to meet the initial targeted launch date in 2018. In Utah and Mississippi, booster and engine testing are verifying upgrades made to proven shuttle hardware. At Michoud Assembly Facility (MAF) in Louisiana, the world's largest spacecraft welding tool is producing tanks for the SLS core stage. This paper will particularly focus on

The Essential Medicinal Chemistry of Curcumin.

PubMed

Nelson, Kathryn M; Dahlin, Jayme L; Bisson, Jonathan; Graham, James; Pauli, Guido F; Walters, Michael A

2017-03-09

Curcumin is a constituent (up to ∼5%) of the traditional medicine known as turmeric. Interest in the therapeutic use of turmeric and the relative ease of isolation of curcuminoids has led to their extensive investigation. Curcumin has recently been classified as both a PAINS (pan-assay interference compounds) and an IMPS (invalid metabolic panaceas) candidate. The likely false activity of curcumin in vitro and in vivo has resulted in >120 clinical trials of curcuminoids against several diseases. No double-blinded, placebo controlled clinical trial of curcumin has been successful. This manuscript reviews the essential medicinal chemistry of curcumin and provides evidence that curcumin is an unstable, reactive, nonbioavailable compound and, therefore, a highly improbable lead. On the basis of this in-depth evaluation, potential new directions for research on curcuminoids are discussed.

The Essential Medicinal Chemistry of Curcumin

PubMed Central

2017-01-01

Curcumin is a constituent (up to ∼5%) of the traditional medicine known as turmeric. Interest in the therapeutic use of turmeric and the relative ease of isolation of curcuminoids has led to their extensive investigation. Curcumin has recently been classified as both a PAINS (pan-assay interference compounds) and an IMPS (invalid metabolic panaceas) candidate. The likely false activity of curcumin in vitro and in vivo has resulted in >120 clinical trials of curcuminoids against several diseases. No double-blinded, placebo controlled clinical trial of curcumin has been successful. This manuscript reviews the essential medicinal chemistry of curcumin and provides evidence that curcumin is an unstable, reactive, nonbioavailable compound and, therefore, a highly improbable lead. On the basis of this in-depth evaluation, potential new directions for research on curcuminoids are discussed. PMID:28074653

Herbal medicine (Hyeolbuchukeo-tang or Xuefu Zhuyu decoction) for treating primary dysmenorrhoea: protocol for a systematic review of randomised controlled trials.

PubMed

Jo, Junyoung; Leem, Jungtae; Lee, Jin Moo; Park, Kyoung Sun

2017-06-15

Primary dysmenorrhoea is menstrual pain without pelvic pathology and is the most common gynaecological condition in women. Xuefu Zhuyudecoction (XZD) or Hyeolbuchukeo-tang, a traditional herbal formula, has been used as a treatment for primary dysmenorrhoea. The purpose of this study is to assess the current published evidence regarding XZD as treatment for primary dysmenorrhoea. The following databases will be searched from their inception until April 2017: MEDLINE (via PubMed), Allied and Complementary Medicine Database (AMED), EMBASE, The Cochrane Library, six Korean medical databases (Korean Studies Information Service System, DBPia, Oriental Medicine Advanced Searching Integrated System, Research Information Service System, Korea Med and the Korean Traditional Knowledge Portal), three Chinese medical databases (China National Knowledge Infrastructure (CNKI), Wan Fang Database and Chinese Scientific Journals Database (VIP)) and one Japanese medical database (CiNii). Randomised clinical trials (RCTs) that will be included in this systematic review comprise those that used XZD or modified XZD. The control groups in the RCTs include no treatment, placebo, conventional medication or other treatments. Trials testing XZD as an adjunct to other treatments and studies where the control group received the same treatment as the intervention group will be also included. Data extraction and risk of bias assessments will be performed by two independent reviewers. The risk of bias will be assessed with the Cochrane risk of bias tool. All statistical analyses will be conducted using Review Manager software (RevMan V.5.3.0). This systematic review will be published in a peer-reviewed journal. The review will also be disseminated electronically and in print. The review will benefit patients and practitioners in the fields of traditional and conventional medicine. CRD42016050447. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017

46 CFR 133.120 - Launching stations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 4 2012-10-01 2012-10-01 false Launching stations. 133.120 Section 133.120 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OFFSHORE SUPPLY VESSELS LIFESAVING SYSTEMS Requirements for All OSVs § 133.120 Launching stations. (a) Each launching station must be positioned to ensure...

46 CFR 133.120 - Launching stations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 4 2014-10-01 2014-10-01 false Launching stations. 133.120 Section 133.120 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) OFFSHORE SUPPLY VESSELS LIFESAVING SYSTEMS Requirements for All OSVs § 133.120 Launching stations. (a) Each launching station must be positioned to ensure...

Magnetic Launch Assist System Demonstration Test

NASA Technical Reports Server (NTRS)

2001-01-01

Engineers at the Marshall Space Flight Center (MSFC) have been testing Magnetic Launch Assist Systems, formerly known as Magnetic Levitation (MagLev) technologies. To launch spacecraft into orbit, a Magnetic Launch Assist system would use magnetic fields to levitate and accelerate a vehicle along a track at a very high speed. Similar to high-speed trains and roller coasters that use high-strength magnets to lift and propel a vehicle a couple of inches above a guideway, the launch-assist system would electromagnetically drive a space vehicle along the track. A full-scale, operational track would be about 1.5-miles long and capable of accelerating a vehicle to 600 mph in 9.5 seconds. This photograph shows a subscale model of an airplane running on the experimental track at MSFC during the demonstration test. This track is an advanced linear induction motor. Induction motors are common in fans, power drills, and sewing machines. Instead of spinning in a circular motion to turn a shaft or gears, a linear induction motor produces thrust in a straight line. Mounted on concrete pedestals, the track is 100-feet long, about 2-feet wide, and about 1.5- feet high. The major advantages of launch assist for NASA launch vehicles is that it reduces the weight of the take-off, the landing gear, the wing size, and less propellant resulting in significant cost savings. The US Navy and the British MOD (Ministry of Defense) are planning to use magnetic launch assist for their next generation aircraft carriers as the aircraft launch system. The US Army is considering using this technology for launching target drones for anti-aircraft training.

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

Personomics: The Missing Link in the Evolution from Precision Medicine to Personalized Medicine.

PubMed

Ziegelstein, Roy C

2017-10-16

Clinical practice guidelines have been developed for many common conditions based on data from randomized controlled trials. When medicine is informed solely by clinical practice guidelines, however, the patient is not treated as an individual, but rather a member of a group. Precision medicine, as defined herein, characterizes unique biological characteristics of the individual or of specimens obtained from an individual to tailor diagnostics and therapeutics to a specific patient. These unique biological characteristics are defined by the tools of precision medicine: genomics, proteomics, metabolomics, epigenomics, pharmacogenomics, and other "-omics." Personalized medicine, as defined herein, uses additional information about the individual derived from knowing the patient as a person. These unique personal characteristics are defined by tools known as personomics which takes into account an individual's personality, preferences, values, goals, health beliefs, social support network, financial resources, and unique life circumstances that affect how and when a given health condition will manifest in that person and how that condition will respond to treatment. In this paradigm, precision medicine may be considered a necessary step in the evolution of medical care to personalized medicine, with personomics as the missing link.

Launch of STS-63 Discovery

NASA Technical Reports Server (NTRS)

1995-01-01

A 70mm camera was used to expose this image of the Space Shuttle Discovery as it began its race to catch up with Russia's Mir Space Station. Liftoff from Launch Pad 39B, Kennedy Space Center (KSC) occurred at 12:22:04 (EST) February 3, 1995. Discovery is the first in the current fleet of four space shuttle vehicles to make 20 launches. The launch pad and orbiter can be seen reflected in the water directly in front of it.

Launch of STS-63 Discovery

NASA Technical Reports Server (NTRS)

1995-01-01

A 35mm camera was used to expose this image of the Space Shuttle Discovery as it began its race to catch up with Russia's Mir Space Station. Liftoff from Launch Pad 39B, Kennedy Space Center (KSC) occurred at 12:22:04 (EST) February 3, 1995. Discovery is the first in the current fleet of four space shuttle vehicles to make 20 launches. The launch pad and orbiter can be seen reflected in the water directly in front of it.

The Aquila launch service for small satellites

NASA Astrophysics Data System (ADS)

Whittinghill, George R.; McKinney, Bevin C.

1992-07-01

The Aquila launch vehicle is described emphasizing its use in the deployment of small satellites for the commercial sector. The Aquila is designed to use a guidance, navigation, and control system, and the rocket is based on hybrid propulsion incorporating a liquid oxidizer with a solid polybutadiene fuel. The launch vehicle for the system is a ground-launched four-stage vehicle that can deliver 3,200 lbs of payload into a 185-km circular orbit at 90-deg inclination. Aquila avionics include inertial navigation, radar transponder, and an S-band telemetry transmitter. The payload environment minimizes in-flight acoustic levels, and the launch-ascent profile is characterized by low acceleration. The launch vehicle uses low-cost rocket motors, a high-performance LO(x) feed system, and erector launch capability which contribute to efficient launches for commercial payloads for low polar earth orbits.

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)

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

Consumer input into research: the Australian Cancer Trials website

PubMed Central

2011-01-01

Background The Australian Cancer Trials website (ACTO) was publicly launched in 2010 to help people search for cancer clinical trials recruiting in Australia, provide information about clinical trials and assist with doctor-patient communication about trials. We describe consumer involvement in the design and development of ACTO and report our preliminary patient evaluation of the website. Methods Consumers, led by Cancer Voices NSW, provided the impetus to develop the website. Consumer representative groups were consulted by the research team during the design and development of ACTO which combines a search engine, trial details, general information about trial participation and question prompt lists. Website use was analysed. A patient evaluation questionnaire was completed at one hospital, one week after exposure to the website. Results ACTO's main features and content reflect consumer input. In February 2011, it covered 1, 042 cancer trials. Since ACTO's public launch in November 2010, until the end of February 2011, the website has had 2, 549 new visits and generated 17, 833 page views. In a sub-study of 47 patient users, 89% found the website helpful for learning about clinical trials and all respondents thought patients should have access to ACTO. Conclusions The development of ACTO is an example of consumers working with doctors, researchers and policy makers to improve the information available to people whose lives are affected by cancer and to help them participate in their treatment decisions, including consideration of clinical trial enrolment. Consumer input has ensured that the website is informative, targets consumer priorities and is user-friendly. ACTO serves as a model for other health conditions. PMID:21703017

A novel drug management system in the Febuxostat versus Allopurinol Streamlined Trial: A description of a pharmacy system designed to supply medications directly to patients within a prospective multicenter randomised clinical trial.

PubMed

Rogers, Amy; Flynn, Robert Wv; McDonnell, Patrick; Mackenzie, Isla S; MacDonald, Thomas M

2016-12-01

Trials of investigational medicinal products are required to adhere to strict guidelines with regard to the handling and supply of medication. Information technology offers opportunities to approach clinical trial methodology in new ways. This report summarises a novel pharmacy system designed to supply trial medications directly to patients by post in the Febuxostat versus Allopurinol Streamlined Trial. A bespoke web-based software package was designed to facilitate the direct supply of trial medications to Febuxostat versus Allopurinol Streamlined Trial participants from a pharmacy based in the Medicines Monitoring Unit, University of Dundee. To date, 65,467 packs of medication have been dispensed using the system to 3978 patients. Up to 238 packs per day have been dispensed. The Medicines Monitoring Unit Febuxostat versus Allopurinol Streamlined Trial drug management system is an effective method of administering the complex drug supply requirements of a large-scale clinical trial with advantages over existing arrangements. A low rate of loss to follow-up in the Febuxostat versus Allopurinol Streamlined Trial may be attributable to the drug management system. © The Author(s) 2016.

A meta-analysis of Chinese herbal medicines for vascular dementia.

PubMed

Qin, Xiude; Liu, Yu; Wu, Yanqing; Wang, Shuo; Wang, Dandan; Zhu, Jinqiang; Ye, Qiaofeng; Mou, Wei; Kang, Liyuan

2013-06-25

To investigate the efficacy and safety of Chinese herbal medicines in the treatment of patients with vascular dementia. We retrieved publications from Cochrane Library (2004 to July 2011), PubMed (1966 to July 2011), the Chinese Science and Technique Journals Database (1977 to July 2011), the China National Knowledge Infrastructure (1979 to July 2011), Google Scholar (July 2011), and the Chinese Biomedical Database (1977 to July 2011) using the key words "Chinese medicine OR Chinese herbal medicine" and "vascular dementia OR mild cognition impair OR multi-infarct dementia OR small-vessel dementia OR strategic infarct dementia OR hypoperfusion dementia OR hemorrhagic dementia OR hereditary vascular dementia". Randomized controlled trials comparing Chinese herbal medicines with placebo/western medicine in the treatment of patients with vascular dementia were included. Diagnostic standards included Diagnostic and Statistical Manual of Mental Disorders-IV, and National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherché et l'Enseignement en Neurosciences. Two participants independently conducted literature screening, quality evaluation and data extraction. The quality of each trial was assessed according to the Cochrane Reviewers' Handbook 5.0. Effective rate, Mini-Mental State Examination scores, Hasegawa Dementia Scale scores, and incidence of adverse reactions. We identified 1 143 articles discussing the effects of Chinese medicine on vascular dementia. Thirty-one of these were included in the analysis. These studies involved a total of 2 868 participants (1 605 patients took Chinese medicine decoctions (treatment group); 1 263 patients took western medicine or placebo). The results of our meta-analysis revealed that Chinese herbal remedies in the treatment group were more efficacious than the control intervention (relative risk (RR) = 1.27; 95% confidence interval (CI): 1.18-1.38, P < 0.01). Mini-Mental State Examination

Are mushrooms medicinal?

PubMed

Money, Nicholas P

2016-04-01

Despite the longstanding use of dried mushrooms and mushroom extracts in traditional Chinese medicine, there is no scientific evidence to support the effectiveness of these preparations in the treatment of human disease. Consumers should evaluate assertions made by companies about the miraculous properties of medicinal mushrooms very critically. The potential harm caused by these natural products is another important consideration. In a more positive vein, the presence of potent toxins and neurotropic compounds in basidiomycete fruit bodies suggests that secondary metabolites with useful pharmacological properties are widespread in these fungi. Major investment in controlled experiments and objective clinical trials is necessary to develop this natural pharmacopeia. Copyright © 2016 The Author. Published by Elsevier Ltd.. All rights reserved.

The Application of the NASA Advanced Concepts Office, Launch Vehicle Team Design Process and Tools for Modeling Small Responsive Launch Vehicles

NASA Technical Reports Server (NTRS)

Threet, Grady E.; Waters, Eric D.; Creech, Dennis M.

2012-01-01

The Advanced Concepts Office (ACO) Launch Vehicle Team at the NASA Marshall Space Flight Center (MSFC) is recognized throughout NASA for launch vehicle conceptual definition and pre-phase A concept design evaluation. The Launch Vehicle Team has been instrumental in defining the vehicle trade space for many of NASA s high level launch system studies from the Exploration Systems Architecture Study (ESAS) through the Augustine Report, Constellation, and now Space Launch System (SLS). The Launch Vehicle Team s approach to rapid turn-around and comparative analysis of multiple launch vehicle architectures has played a large role in narrowing the design options for future vehicle development. Recently the Launch Vehicle Team has been developing versions of their vetted tools used on large launch vehicles and repackaged the process and capability to apply to smaller more responsive launch vehicles. Along this development path the LV Team has evaluated trajectory tools and assumptions against sounding rocket trajectories and air launch systems, begun altering subsystem mass estimating relationships to handle smaller vehicle components, and as an additional development driver, have begun an in-house small launch vehicle study. With the recent interest in small responsive launch systems and the known capability and response time of the ACO LV Team, ACO s launch vehicle assessment capability can be utilized to rapidly evaluate the vast and opportune trade space that small launch vehicles currently encompass. This would provide a great benefit to the customer in order to reduce that large trade space to a select few alternatives that should best fit the customer s payload needs.

The applications of regenerative medicine in sinus lift procedures: A systematic review.

PubMed

Correia, Francisco; Pozza, Daniel Humberto; Gouveia, Sónia; Felino, António; Faria E Almeida, Ricardo

2018-04-01

Findings in regenerative medicine applied to the sinus lift procedures. Evaluate the effectiveness of regenerative medicine in sinus lift. An extensive search for manuscripts were performed by using different combinations of keywords and MeSH terms (Pub-med; Embase; Scopus; Web of Science Core Collection; Medline; Current Contents Connect; Derwent Innovations Index; Scielo Citation Index; Cochrane library). The full text selected articles are written in English, Portuguese, Spanish, Italian, German, or French, and published until 28 of November 2016. Inclusion criteria were: implant osteointegration, radiographic, histologic, and/or histomorphometric analysis, clinical studies in humans using of regenerative medicine. This systematic review was performed by selecting only randomized controlled clinical trials and controlled clinical trials. Eighteen published studies (11 CT and 7 RCT) were considered eligible for inclusion in the present systematic review. These studies demonstrated considerable variation of biomaterial and cell technics used, study design, sinus lift technic, outcomes, follow-up, and results. Only few studies have demonstrated potential of regenerative medicine in sinus lift; further randomized clinical trials are needed to achieve more accurate results. © 2017 Wiley Periodicals, Inc.

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.

From Evidence Based Medicine to Medicine Based Evidence.

PubMed

Horwitz, Ralph I; Hayes-Conroy, Allison; Caricchio, Roberto; Singer, Burton H

2017-11-01

Evidence based medicine, using randomized controlled trials and meta-analyses as the major tools and sources of evidence about average results for heterogeneous groups of patients, developed as a reaction against poorly designed observational treatment research and physician reliance on personal experience with other patients as a guide to decision-making about a patient at hand. However, these tools do not answer the clinician's question: "Will a given therapeutic regimen help my patient at a given point in her/his clinical course?" We introduce fine-grained profiling of the patient at hand, accompanied by comparative evidence of responses from approximate matches to this patient on whom a contemplated treatment has/has not been administered. This represents medicine based evidence that is tuned to decision-making for the particular patient. Copyright © 2017 Elsevier Inc. All rights reserved.

Study of launch site processing and facilities for future launch vehicles

NASA Astrophysics Data System (ADS)

Shaffer, Rex

1995-03-01

The purpose of this research is to provide innovative and creative approaches to assess the impact to the Kennedy Space Center and other launch sites for a range of candidate manned and unmanned space transportation systems. The general scope of the research includes the engineering activities, analyses, and evaluations defined in the four tasks below: (1) development of innovative approaches and computer aided tools; (2) operations analyses of launch vehicle concepts and designs; (3) assessment of ground operations impacts; and (4) development of methodologies to identify promising technologies.

Study of launch site processing and facilities for future launch vehicles

NASA Technical Reports Server (NTRS)

Shaffer, Rex

1995-01-01

The purpose of this research is to provide innovative and creative approaches to assess the impact to the Kennedy Space Center and other launch sites for a range of candidate manned and unmanned space transportation systems. The general scope of the research includes the engineering activities, analyses, and evaluations defined in the four tasks below: (1) development of innovative approaches and computer aided tools; (2) operations analyses of launch vehicle concepts and designs; (3) assessment of ground operations impacts; and (4) development of methodologies to identify promising technologies.

The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov

PubMed Central

Huang, Jihan; Li, Jordan V.; Lv, Yinghua; He, Yingchun

2017-01-01

Objective The aim of this review is to characterize current status of global TCM clinical trials registered in ClinicalTrials.gov. Methods We examined all the trials registered within ClinicalTrials.gov up to 25 September 2015, focusing on study interventions to identify TCM-related trials, and extracted 1,270 TCM trials from the data set. Results Overall, 691 (54.4%) trials were acupuncture, and 454 (35.8%) trials were herbal medicines. Differences in TCM trial intervention types were also evident among the specific therapeutic areas. Among all trials, 55.7% that were small studies enrolled <100 subjects, and only 8.7% of completed studies had reported results of trials. As for the location, the United States was second to China in conducting the most TCM trials. Conclusion This review is the first snapshot of the landscape of TCM clinical trials registered in ClinicalTrials.gov, providing the basis for treatment and prevention of diseases within TCM and offering useful information that will guide future research on TCM. PMID:29138646

Space Launch System Spacecraft and Payload Elements: Making Progress Toward First Launch

NASA Technical Reports Server (NTRS)

Schorr, Andrew A.; Creech, Stephen D.

2016-01-01

Significant and substantial progress continues to be accomplished in the design, development, and testing of the Space Launch System (SLS), the most powerful human-rated launch vehicle the United States has ever undertaken. Designed to support human missions into deep space, SLS is one of three programs being managed by the National Aeronautics and Space Administration's (NASA's) Exploration Systems Development directorate. The Orion spacecraft program is developing a new crew vehicle that will support human missions beyond low Earth orbit, and the Ground Systems Development and Operations program is transforming Kennedy Space Center into next-generation spaceport capable of supporting not only SLS but also multiple commercial users. Together, these systems will support human exploration missions into the proving ground of cislunar space and ultimately to Mars. SLS will deliver a near-term heavy-lift capability for the nation with its 70 metric ton (t) Block 1 configuration, and will then evolve to an ultimate capability of 130 t. The SLS program marked a major milestone with the successful completion of the Critical Design Review in which detailed designs were reviewed and subsequently approved for proceeding with full-scale production. This marks the first time an exploration class vehicle has passed that major milestone since the Saturn V vehicle launched astronauts in the 1960s during the Apollo program. Each element of the vehicle now has flight hardware in production in support of the initial flight of the SLS -- Exploration Mission-1 (EM-1), an un-crewed mission to orbit the moon and return. Encompassing hardware qualification, structural testing to validate hardware compliance and analytical modeling, progress in on track to meet the initial targeted launch date in 2018. In Utah and Mississippi, booster and engine testing are verifying upgrades made to proven shuttle hardware. At Michoud Assembly Facility in Louisiana, the world's largest spacecraft welding

14 CFR 415.119 - Launch plans.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Launch plans. 415.119 Section 415.119... From a Non-Federal Launch Site § 415.119 Launch plans. An applicant's safety review document must contain the plans required by § 417.111 of this chapter, except for the countdown plan of § 417.111(l) of...

Closed End Launch Tube (CELT)

NASA Technical Reports Server (NTRS)

Lueck, Dale E.; Parrish, Clyde F.; Delgado, H. (Technical Monitor)

2000-01-01

As an alternative to magnetic propulsion for launch assist, the authors propose a pneumatic launch assist system. Using off the shelf components, coupled with familiar steel and concrete construction, a launch assist system can be brought from the initial feasibility stage, through a flight capable 5000 kg. demonstrator to a deployed full size launch assist system in 10 years. The final system would be capable of accelerating a 450,000 kg. vehicle to 270 meters per second. The CELT system uses commercially available compressors and valves to build a fail-safe system in less than half the time of a full Mag-Lev (magnetic levitation) system, and at a small fraction of the development cost. The resulting system could be ready in time to support some Gen 2 (generation 2) vehicles, as well as the proposed Gen 3 vehicle.

SKYLAB (SL)-III - LAUNCH - KSC

NASA Image and Video Library

1973-08-17

S73-32570 (28 July 1973) --- The Skylab 3/Saturn 1B space vehicle is launched from Pad B, Launch Complex 39, Kennedy Space Center, Florida, at 7:11 a.m. (EDT), Saturday, July 28, 1973. Skylab 3 is the second of three scheduled Skylab manned missions. Aboard the Skylab 3 Command/Service Module were astronauts Alan L. Bean, Owen K. Garriott and Jack R. Lousma. The Skylab 3 CSM later docked with the Skylab space station cluster in Earth orbit. In addition to the CSM and its launch escape system, the Skylab 3 space vehicle consisted of the Saturn 1B first (S-1B) stage and the Saturn 1B second (S-1VB) stage. (The Skylab 1/Saturn V space vehicle with the space station payload was launched from Pad A on May 14, 1973). Photo credit: NASA

14 CFR 420.19 - Launch site location review-general.

Code of Federal Regulations, 2010 CFR

2010-01-01

... site, at least one type of expendable or reusable launch vehicle can be flown from the launch point... × 10−6). (2) Types of launch vehicles include orbital expendable launch vehicles, guided sub-orbital expendable launch vehicles, unguided sub-orbital expendable launch vehicles, and reusable launch vehicles...

An overview of the U.S. commercial space launch infrastructure : Quarterly Launch Report : special report

DOT National Transportation Integrated Search

1998-01-01

The commercial space transportation industry has witnessed unparalleled growth in the number of commercial launches over the past few years. Last year witnessed the largest number yet, 35 commercial launches worldwide, nearly twice the 21 commercial ...

OSIRIS-REx Rollout for Launch

NASA Image and Video Library

2016-09-07

The United Launch Alliance Atlas V rocket arrives at Space Launch Complex 41 at Cape Canaveral Air Force Station in Florida. The launch vehicle will boost NASA’s Origins, Spectral Interpretation, Resource Identification, Security-Regolith Explorer, or OSIRIS-REx spacecraft. This will be the first U.S. mission to sample an asteroid, retrieve at least two ounces of surface material and return it to Earth for study. The asteroid, Bennu, may hold clues to the origin of the solar system and the source of water and organic molecules found on Earth.

Scout Launch Lift off on Wallops Island

NASA Image and Video Library

1965-08-10

Scout launch vehicle lift off on Wallops Island in 1965. The Scout launch vehicle was used for unmanned small satellite missions, high altitude probes, and reentry experiments. Scout, the smallest of the basic launch vehicles, is the only United States launch vehicle fueled exclusively with solid propellants. Published in the book " A Century at Langley" by Joseph Chambers pg. 92

STS-132 Launch Tweetup

NASA Image and Video Library

2010-05-12

NASA Astronaut Janet Voss 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)

Orion Launch from Helicopter - Aerials

NASA Image and Video Library

2014-12-05

This helicopter view of Space Launch Complex 37 at Cape Canaveral Air Force Station in Florida shows the United Launch Alliance Delta IV Heavy rocket as it stands ready to boost NASA's Orion spacecraft on a 4.5-hour mission.

Launch Pad in a Box

NASA Technical Reports Server (NTRS)

Mantovani, J. G.; Tamasy, G. J.; Mueller, R. P.; Townsend, I. I.; Sampson, J. W.; Lane, M. A.

2016-01-01

NASA Kennedy Space Center (KSC) is developing a new deployable launch system capability to support a small class of launch vehicles for NASA and commercial space companies to test and launch their vehicles. The deployable launch pad concept was first demonstrated on a smaller scale at KSC in 2012 in support of NASA Johnson Space Center's Morpheus Lander Project. The main objective of the Morpheus Project was to test a prototype planetary lander as a vertical takeoff and landing test-bed for advanced spacecraft technologies using a hazard field that KSC had constructed at the Shuttle Landing Facility (SLF). A steel pad for launch or landing was constructed using a modular design that allowed it to be reconfigurable and expandable. A steel flame trench was designed as an optional module that could be easily inserted in place of any modular steel plate component. The concept of a transportable modular launch and landing pad may also be applicable to planetary surfaces where the effects of rocket exhaust plume on surface regolith is problematic for hardware on the surface that may either be damaged by direct impact of high speed dust particles, or impaired by the accumulation of dust (e.g., solar array panels and thermal radiators). During the Morpheus free flight campaign in 2013-14, KSC performed two studies related to rocket plume effects. One study compared four different thermal ablatives that were applied to the interior of a steel flame trench that KSC had designed and built. The second study monitored the erosion of a concrete landing pad following each landing of the Morpheus vehicle on the same pad located in the hazard field. All surfaces of a portable flame trench that could be directly exposed to hot gas during launch of the Morpheus vehicle were coated with four types of ablatives. All ablative products had been tested by NASA KSC and/or the manufacturer. The ablative thicknesses were measured periodically following the twelve Morpheus free flight tests

Launch Pad in a Box