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Sample records for medicine trial launched

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

    Cancer.gov

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

  2. Anchor Trial Launch

    Cancer.gov

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

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

    Cancer.gov

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

  4. Clinical trials and gender medicine.

    PubMed

    Cassese, Mariarita; Zuber, Veronica

    2011-01-01

    Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22%) which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa) which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society. PMID:21430348

  5. Personalized medicine: ethics for clinical trials.

    PubMed

    Sharrer, G Terry

    2012-01-01

    Modern ethical codes in medicine were developed following World War II to provide respect for persons, beneficence, and justice in clinical research. Clinical trial medicine involves greater scrutiny than most research activities. In every instance, clinical trials have institutional review boards to ensure the medical procedure under study complies with regulatory requirements, privacy, informed consent, good practices, safety monitoring, adverse events reporting, and is free of conflicting interests. Mandatory training in medical ethics for all clinical staff is becoming more common, and at some institutions, knowledgeable patient advocates play a watchdog role. In personalized medicine, each patient becomes a clinical trial of one, based on the uniqueness of the person's illness and the relatively tailored treatment. These features imply a shared responsibility between the patient and the researchers because uncertainty exists over the outcome for each individual patient. This chapter introduces ethical considerations using case studies, with historical context, and describes general ethical guidelines for initiating a clinical trial. PMID:22081337

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

    PubMed Central

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

    2010-01-01

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

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

    PubMed

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

    2008-06-01

    One of the important components in randomized Controlled Trial (RCT) is blinding. The gold standard of clinical trials is to achieve a double blind design. However, only a small number of randomized controlled trials in traditional Chinese medicine have been reported, most of them are of poor quality in methodology including placebo preparation and verification. The purpose of the article is to review the validity of placebo used in blinded clinical trials for Chinese herbal medicine (CHM) in recent years and related patents. We searched the Wanfang Database (total of 827 Chinese journals of medicine and/or pharmacy, from 1999 to 2005) and 598 full-length articles related to placebo clinical trials were found. 77 placebo blinded clinical trials for Chinese medicine were extracted by manual search from the 598 articles. After reviewing the 77 full-length articles, we found that nearly half of the clinical trials did not pay attention to the physical quality of the testing drug and placebo and whether they were of comparable physical quality. The rest provided very limited placebo information so that blinding assurance could not be assumed. Only 2 articles (2.6%) specifically validated the comparability between the testing drug and the placebo. Researchers in Chinese medicine commonly ignored the quality of the placebo in comparison to the test drug. This may be causing bias in the clinical trials. Quality specifications and evaluation of the placebo should deserve special attention to reduce bias in randomized controlled trials in TCM study. PMID:19076001

  8. Complementary and Alternative Medicine Cancer Clinical Trials

    MedlinePlus

    ... patients. Currently, what cancer clinical trials are the NCI and medical community sponsoring involving CAM modalities? Cancer CAM clinical trials are listed in NCI’s PDQ ® (Physician Data Query) computer database of clinical ...

  9. Complementary and Alternative Medicine Cancer Clinical Trials

    MedlinePlus

    ... patients. Currently, what cancer clinical trials are the NCI and medical community sponsoring involving CAM modalities? Cancer CAM clinical trials are listed in NCI's PDQ ® (Physician Data Query) computer database of clinical ...

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

    PubMed

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

    2014-10-01

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

  11. Anthroposophical medicine: a systematic review of randomised clinical trials.

    PubMed

    Ernst, Edzard

    2004-02-28

    The aim of this systematic review was to summarise and critically evaluate all randomised clinical trials testing the effectiveness of the whole system of anthroposophical medicine either as a sole or as an adjunctive form of treatment. Seven independent literature searches were conducted to locate all such studies. Trials of single remedies within the wider anthroposophical approach were excluded. No language restrictions were applied. Unfortunately not a single study was located which met the inclusion/exclusion criteria. It was therefore concluded that, at present, the question whether the anthroposophical concept of healing generates more good than harm cannot be answered. PMID:15038403

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

    PubMed Central

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

    2016-01-01

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

  13. 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

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

    PubMed

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

    2015-09-01

    The concept of oncogene addiction was first proposed by Weinstein in 2002, postulating that tumors rely on a single dominant mutation, the oncogenic "driver", for growth and survival. We have since come to realize that the genomic landscape of tumors is heterogeneous and more complex than previously thought. Advances in biotechnology and bioinformatics over the past decade have shifted treatment paradigms with regard to the development of molecular targeted therapeutics to identify and target the presumptive dominant lesion. As such, the decision of choosing targeted treatment strategies has become increasingly more reliant on the reporting of genomic screens of patients' tumor tissue. Whether this change in treatment paradigm will translate into improved clinical benefit, remains to be seen. To this end, the United States National Cancer Institute (NCI) has launched precision-based medicine trials to address this question. NCI Molecular Analysis for Therapy Choice (MATCH), a genomic pre-screening study, was designed to explore the efficacy of using targeted agents to target specific molecular aberrations and whether these same therapies have comparable activity across different tumor subtypes. Molecular Profiling-based Assignment of Cancer Therapy (MPACT), is a smaller, provocative trial designed to address whether targeting an oncogenic "driver" would be more efficacious than one not. The Exceptional Responders' initiative further aims to evaluate patients who have derived an unexpected durable benefit to these therapies, with retrospective analysis of their tumors to delineate potential predictive biomarkers which could predict response. The results of these trials will serve to help guide the field of precision medicine and personalized care. PMID:26408298

  15. Clinical trials with herbal medicinal products in children: a literature analysis.

    PubMed

    Marquardt, Peter; Kaft, Karin; Nieber, Karen

    2015-06-01

    Herbal medicinal products have been used since several decades for the health care of children. Nevertheless, well-controlled clinical studies with herbal medicinal products for children are rare. The authors' objective therefore was to evaluate clinical trials with herbal medicinal products in children, based on a literature search in PubMed and Web of Science. A total of 133 trials were identified. 90 studies were randomized, 32.2% were randomized and double-blinded. Most studies were performed in China, in the age group 6-12 years, and in children with respiratory diseases, most often herbal medicinal products with Hedera helix were tested. The analysis revealed that studies on herbal medicinal products were feasible in children. Although clinical trials have been found, this literature search have limitations and did not cover all studies performed. However, only few clinical trials of high quality were identified. Further studies therefore are urgently needed to support the good empirical findings. PMID:26183729

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  18. A controlled trial of Chinese herbal medicine for premenstrual syndrome.

    PubMed

    Chou, Patsy B; Morse, Carol A; Xu, Hong

    2008-09-01

    Premenstrual syndrome (PMS) is a common disorder troubling many women during their reproductive years. The Chinese have been using herbal medicines to treat menstrual cycle related symptoms for centuries. The present study examined the effectiveness of Chinese herbal medicine for the treatment of PMS among Australian women within the theoretical framework of traditional Chinese medicine (TCM). Sixty-one women were assigned randomly into two groups within different TCM patterns. Herbal medicine and placebo were provided sequentially for a period of three months. There were significant differences (p < 0.01) in scores after three months of treatment between Chinese herbal medicine and placebo in premenstrual physical and psychological symptoms, depression, anxiety and anger favoring herbal medicine, but with no difference in perceived stress (p > 0.05). There were highly significant reductions (p < 0.001) between baseline and the end of the third herbal treatment month in all assessments in both groups except that a significant result (p < 0.05) was recorded on perceived stress only in the herbs-first group. No adverse effects were reported by any participant. The results support the hypothesis that the symptoms occurrence and severity of PMS can be effectively reduced by the use of Chinese herbal medicine. PMID:18608825

  19. Placebo preparation for the proper clinical trial of herbal medicine--requirements, verification and quality control.

    PubMed

    Fai, Cheng K; Qi, Guan De; Wei, Ding A; Chung, Leung P

    2011-05-01

    Randomized controlled trials (RCT) have been recognized as the gold standard for interventional clinical trials. In many clinical trials of herbal medicine, it is very difficult to create a quality placebo. To achieve the purpose of blinding, the characteristics of the real drug and placebo should be identical in color, appearance, smell and taste. The quality placebo should be identical to the real drug in physical form, sensory perception, packaging, and labeling, and it should have no pharmaceutical activity. The aim of this study was to evaluate a placebo capsule and its matching herbal medicine D&G capsule in physical form, chemical nature, appearance, packaging and labeling. The assessment results suggested that the placebo was satisfactory in these aspects. The results demonstrated that a placebo could be created for a RCT involving herbal medicine. This report also discusses the means to acquire patent. PMID:21457134

  20. Randomized controlled trials in diving and hyperbaric medicine.

    PubMed

    Bennett, Michael H

    2013-01-01

    Randomized controlled trials (RCTs) are widely accepted as the most appropriate methodology available for the investigation of health interventions. This is because of the low potential for systematic bias and the ability to assume causality. Well-designed RCTs, often modified by the addition of blinding participants to the treatment allocated, greatly assist physicians and funding agencies in deciding on the most effective and cost-efficient methods available to prevent and treat ill health. One of the problems for hyperbaric physicians is the widely scattered nature of the evidence, making retrieval and appraisal problematic. This review assembles the randomized evidence in order to assist practitioners, discusses the nature of randomized trials and explores approaches to designing and performing powerful and convincing trials in this area. It is extracted from the UHMS Report Hyperbaric Oxygen Therapy Indications. PMID:24224286

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

    PubMed Central

    2013-01-01

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

  2. Chinese patent medicine tongxinluo capsule for hypertension: a systematic review of randomised controlled trials.

    PubMed

    Wang, Jie; Xiong, Xingjiang; Liu, Wei

    2014-01-01

    This study was intended to evaluate the efficacy and safety of Tongxinluo capsule for hypertension. Search Strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, The PubMed, EMBASE, Chinese Bio-Medical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database, and Wan-fang Data started from the first of database to October 28, 2013. No language restriction was applied. We included randomized clinical trials testing Tongxinluo capsule against western medicine, Tongxinluo capsule versus placebo, and Tongxinluo capsule combined with western medicine versus western medicine. Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards. Results. 25 trials with 1958 participants were included. The methodological quality of the included trials was evaluated as generally low. The blood pressure (BP) lowering effect of Tongxinluo capsule plus western medicine was significantly higher than that of western medicine (systolic blood pressure (SBP): -3.87, -5.32 to -2.41, P < 0.00001; and diastolic blood pressure (DBP): -2.72, -4.19 to -1.24, P = 0.0003). The BP also decreased significantly from baseline with Tongxinluo capsule than placebo (SBP: -9.40, -10.90 to -7.90, P < 0.00001; and DBP: -11.80, -12.40 to -11.20, P < 0.00001) or western medicine (SBP: -3.90, -4.93 to -2.87, P < 0.00001; and DBP: -3.70, -3.83 to -3.57, P < 0.00001). 12 trials reported adverse events without details. Conclusions. There is some but weak evidence about the effectiveness of TXL in treating patients with hypertension. PMID:24693319

  3. Chinese Patent Medicine Tongxinluo Capsule for Hypertension: A Systematic Review of Randomised Controlled Trials

    PubMed Central

    Wang, Jie; Xiong, Xingjiang; Liu, Wei

    2014-01-01

    Background. This study was intended to evaluate the efficacy and safety of Tongxinluo capsule for hypertension. Search Strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, The PubMed, EMBASE, Chinese Bio-Medical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database, and Wan-fang Data started from the first of database to October 28, 2013. No language restriction was applied. We included randomized clinical trials testing Tongxinluo capsule against western medicine, Tongxinluo capsule versus placebo, and Tongxinluo capsule combined with western medicine versus western medicine. Study selection, data extraction, quality assessment, and data analyses were conducted according to the Cochrane standards. Results. 25 trials with 1958 participants were included. The methodological quality of the included trials was evaluated as generally low. The blood pressure (BP) lowering effect of Tongxinluo capsule plus western medicine was significantly higher than that of western medicine (systolic blood pressure (SBP): −3.87, −5.32 to −2.41, P < 0.00001; and diastolic blood pressure (DBP): −2.72, −4.19 to −1.24, P = 0.0003). The BP also decreased significantly from baseline with Tongxinluo capsule than placebo (SBP: −9.40, −10.90 to −7.90, P < 0.00001; and DBP: −11.80, −12.40 to −11.20, P < 0.00001) or western medicine (SBP: −3.90, −4.93 to −2.87, P < 0.00001; and DBP: −3.70, −3.83 to −3.57, P < 0.00001). 12 trials reported adverse events without details. Conclusions. There is some but weak evidence about the effectiveness of TXL in treating patients with hypertension. PMID:24693319

  4. A review of clinical trials of lithium in medicine.

    PubMed

    Yung, C Y

    1984-01-01

    Since the approval of lithium use in treatment of acute mania, there have been numerous clinical trials of lithium in medical and psychiatric disorders. This paper gives a brief review of the literature on lithium trials in approximately fourteen medical conditions. These are: hyperthyroidism, metabolizing thyroid cancer, syndrome of inappropriate secretion of antidiuretic hormone, premenstrual tension syndrome, anorexia nervosa, Felty's syndrome, chemotherapy-induced neutropenia, aplastic anemia, seborrheic dermatitis, eczematoid dermatitis, cyclic vomiting, diabetes mellitus and asthma. Most of the case reports cited showed the efficacy of the side effects from lithium salt in the management of the symptoms and signs of these disorders, however, well-designed and controlled studies give negative results. The positive results are reported in the group of disorders having an underlying subdromal affective syndrome such as premenstrual tension syndrome and anorexia nervosa. Other encouraging reports include the effect of lithium to induce leucocytosis in Felty's syndrome and chemotherapy-induced neutropenia. PMID:6395135

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

    PubMed Central

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

    2014-01-01

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

  6. A systematic review of randomised clinical trials of individualised herbal medicine in any indication

    PubMed Central

    Guo, R; Canter, P H; Ernst, E

    2007-01-01

    Aim To summarise and critically evaluate the evidence from randomised clinical trials for the effectiveness of individualised herbal medicine in any indication. Methods Search of electronic databases and approaches to experts in the field to identify randomised, controlled clinical trials of individualised herbal medicine in any indication. Independent data extraction and assessment of methodological quality by two authors and best evidence synthesis. Results Three randomised clinical trials of individualised herbal medicine were identified. Statistically non‐significant trends favouring active over placebo treatment in osteoarthritis of the knee probably result from large baseline differences and regression to the mean. Individualised treatment was superior to placebo in four of five outcome measures in the treatment of irritable bowel syndrome, but was inferior to standardised herbal treatment in all outcomes. Individualised herbal treatment was no better than placebo in the prevention of chemotherapy‐induced toxicity. Conclusions There is a sparsity of evidence regarding the effectiveness of individualised herbal medicine and no convincing evidence to support the use of individualised herbal medicine in any indication. PMID:17916871

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

    PubMed Central

    2014-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  9. 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. PMID:26598514

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

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

    2011-01-01

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

  12. 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. PMID:24857062

  13. Syndrome Differentiation in Chinese Herbal Medicine for Irritable Bowel Syndrome: A Literature Review of Randomized Trials

    PubMed Central

    Li, Qing; Yang, Guo-Yan; Liu, Jian-Ping

    2013-01-01

    Traditional Chinese medicine (TCM) has been commonly used for irritable bowel syndrome (IBS). Syndrome differentiation is one of the important characteristics of TCM. To assess the application and basic characteristics of syndrome differentiation in randomized controlled trials (RCTs) of Chinese herbal medicine for IBS, we performed this paper. We conducted electronic searches in main Chinese and English databases till March 2012. A total of 735 RCTs involving 67,784 IBS participants were included. 224 (30.5%) studies applied syndrome differentiation. The major syndromes of IBS patients were the syndrome of liver stagnation and spleen deficiency (56.8%), spleen-stomach weakness (49.4%), spleen-kidney yang deficiency (48.1%), and cold and heat in complexity (29.6%). Herbal formulas were prescribed based on syndrome differentiation in 202 studies. Chinese patent medicine was more commonly used in studies that only enrolled patients with a specific syndrome. 15 studies compared the therapeutic effect among different syndromes, of which 6 studies showed that there were significant differences among different syndromes. The low use of TCM syndrome differentiation in randomized trials of Chinese herbal medicine for IBS results in the poor pertinence of treatment. TCM syndrome differentiation should be used in further studies at the stage of recruitment, treatment, and data analyses. PMID:23554827

  14. Chinese Herbal Medicine in Treating Primary Sjögren's Syndrome: A Systematic Review of Randomized Trials

    PubMed Central

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

    2012-01-01

    Background. There is no curative treatment for primary Sjögren's syndrome (PSS). Chinese herbal medicine (CHM) is widely used in the treatment of PSS in China. Objective. To evaluate the effectiveness and safety of CHM for PSS. Methods. PubMed, Cochrane Library, China Knowledge Resource Integrated Database, Chinese Biomedical Database, Wanfang Data, and the Database for Chinese Technical Periodicals were searched for randomized controlled trials (RCTs) of CHM or CHM plus conventional medicine for PSS compared with placebo or conventional medicine. RevMan 5.0.17 was employed to conduct data analyses and assess homogeneity. Statistical models were chosen according to heterogeneity. Results. A total of 52 RCTs were included. The overall methodological quality of included trials was low. 49 trials reported response rates, of which 32 found significant improvements favoring CHM treatment against controls; 20 trials reported lacrimal function by Schirmer test scores, of which 16 trials reported a significant difference favoring CHM treatment. 21 trials reported salivary function by salivary flow rate, of which 10 reported significant favorable effects of CHM treatment. Other trials found no difference. The reported adverse effects of CHM included nausea, diarrhea, and other minor digestive symptoms, but more frequent adverse effects occurred in conventional medicine groups. Conclusions. Preliminary evidence from RCTs suggests the effect of CHM is promising for relieving symptoms, improving lacrimal and salivary function in PSS. However, the poor methodological quality of the included trials means that further well-designed, multicentered, larger trials are needed. PMID:22969828

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2008-01-01

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

  17. 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

  18. Chinese Herbal Medicine for Postinfectious Cough: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Liu, Wei; Jiang, Hong-Li; Mao, Bing

    2013-01-01

    Chinese herbal medicine has been commonly used in the treatment of postinfectious cough. The aim of this review is to systematically evaluate the efficacy and safety of Chinese herbal medicine for postinfectious cough. An extensive search for RCTs was performed using multiple electronic databases, supplemented with a manual search. All studies included were confirmed with specific inclusion criteria. Methodological quality of each study was examined according to the Cochrane risk of bias assessment. Quality of evidence was evaluated using rating approach developed by GRADE working group. The literature search yielded 352 results, of which 12 RCTs satisfied the inclusion criteria, offering moderate-to-high levels of evidence. Methodological quality was considered high in three trials, while in the other nine studies the unclear risk of bias was in the majority. Findings suggested that, compared with western conventional medicine or placebo, Chinese herbal medicine could effectively improve core symptoms of postinfectious cough, act better and have earlier antitussive effect, and enhance patients' quality of life. No serious adverse event was reported. PMID:24348727

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed

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

    2016-01-01

    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

  2. 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

  3. Herbal Medicines for Parkinson's Disease: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Kim, Tae-Hun; Cho, Ki-Ho; Jung, Woo-Sang; Lee, Myeong Soo

    2012-01-01

    Objective We conducted systematic review to evaluate current evidence of herbal medicines (HMs) for Parkinson's disease (PD). Methods Along with hand searches, relevant literatures were located from the electronic databases including CENTRAL, MEDLINE, EMBASE, CINAHL, AMED, PsycInfo, CNKI, 7 Korean Medical Databases and J-East until August, 2010 without language and publication status. Randomized controlled trials (RCTs), quasi-randomized controlled trials and randomized crossover trials, which evaluate HMs for idiopathic PD were selected for this review. Two independent authors extracted data from the relevant literatures and any disagreement was solved by discussion. Results From the 3432 of relevant literatures, 64 were included. We failed to suggest overall estimates of treatment effects on PD because of the wide heterogeneity of used herbal recipes and study designs in the included studies. When compared with placebo, specific effects were not observed in favor of HMs definitely. Direct comparison with conventional drugs suggested that there was no evidence of better effect for HMs. Many studies compared combination therapy with single active drugs and combination therapy showed significant improvement in PD related outcomes and decrease in the dose of anti-Parkinson's drugs with low adverse events rate. Conclusion Currently, there is no conclusive evidence about the effectiveness and efficacy of HMs on PD. For establishing clinical evidence of HMs on PD, rigorous RCTs with sufficient statistical power should be promoted in future. PMID:22615738

  4. Consolidated standards of reporting trials (CONSORT) for traditional Chinese medicine: current situation and future development.

    PubMed

    Bian, Zhaoxiang; Liu, Baoyan; Moher, David; Wu, Taixiang; Li, Youping; Shang, Hongcai; Cheng, Chungwah

    2011-06-01

    The reporting standards for randomized controlled trials were first published in 1996 by a group of scientists under the name "CONSORT," which means consolidated standards of reporting trials. Revisions followed in 2001 and 2010. A draft of the CONSORT for traditional Chinese medicine (TCM) was published in both Chinese and English in 2007. After publication of the draft, comments were solicited from the medical community. Some papers did raise concerns about which items should be included in the CONSORT for TCM such as the rationale of the trial design, intervention, outcome assessment, and adverse events. We have now reached the next step which is the finalization of the CONSORT for TCM. Three tasks remain. First, the major changes in CONSORT statement 2010 should be integrated into the CONSORT for TCM. Second, Chinese drugs from minerals and animals should be included in the guidelines. Finally, agreement must be reached among the working groups. Once the draft is finalized, wide dissemination and co-publication will be considered. PMID:21695622

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

    PubMed Central

    Schroeder, Knut; Fahey, Tom

    2002-01-01

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

  6. A prospective, randomized trial of integrative medicine for women with ovarian cancer☆,☆☆

    PubMed Central

    Judson, Patricia L.; Dickson, Elizabeth L.; Argenta, Peter A.; Xiong, Yin; Geller, Melissa A.; Carson, Linda F.; Ghebre, Rahel; Jonson, Amy L.; Downs, Levi S.

    2012-01-01

    Objectives Despite increased use of integrative medicine in cancer therapy, little data exist on its efficacy. This prospective, randomized, pilot trial sought to evaluate the feasibility of combined modality integrative medicine (CM-IM) in women with ovarian cancer (OvCA) and evaluate its effects on quality of life (QoL), chemotherapy toxicity and immunologic profiles. Methods Women with newly diagnosed OvCA requiring chemotherapy were offered enrollment. Those randomized to the experimental arm received hypnosis, therapeutic massage and healing touch with each cycle of chemotherapy. The control arm received chemotherapy without CM-IM. All patients completed QoL questionnaires prior to cycles 1, 3 and 6, and 6-months after chemotherapy. Immunologic profiles were measured. Statistical analysis was based on intent-to-treat. Student’s t-test and Fischer’s exact-test were used to determine differences. Results Forty-three women enrolled. All women randomized to CM-IM were successfully treated. There were no statistical differences between the groups in age, stage, grade, histologic cell type, CA125 levels, or surgical cytoreductive status. There was no difference in overall QoL measurements. Re-hospitalization rates, treatment delays, anti-emetic use, and infection rates were similar. Immunologic profiles revealed no difference between arms for WBC or salivary IgA levels. Women receiving CM-IM had consistently higher levels of CD4, CD8 and NK cells, although this did not reach statistical significance. Conclusions Prospective clinical evaluation of integrative medicine for women with gynecologic malignancy is feasible. This first, pilot study of CM-IM in gynecologic oncology demonstrated no improvement in QoL or chemotherapy toxicity. Integrative medicine-associated improvements in immunologic profiles warrant further investigation. PMID:21864886

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

    PubMed Central

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

    2014-01-01

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

  8. 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. PMID:11934908

  9. 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

  10. Launching a Novel Preclinical Infrastructure: Comparative Oncology Trials Consortium Directed Therapeutic Targeting of TNFα to Cancer Vasculature

    PubMed Central

    Mazcko, Christina; Hanna, Engy; Kachala, Stefan; LeBlanc, Amy; Newman, Shelley; Vail, David; Henry, Carolyn; Thamm, Douglas; Sorenmo, Karin; Hajitou, Amin; Pasqualini, Renata; Arap, Wadih

    2009-01-01

    Background Under the direction and sponsorship of the National Cancer Institute, we report on the first pre-clinical trial of the Comparative Oncology Trials Consortium (COTC). The COTC is a novel infrastructure to integrate cancers that naturally develop in pet dogs into the development path of new human drugs. Trials are designed to address questions challenging in conventional preclinical models and early phase human trials. Large animal spontaneous cancer models can be a valuable addition to successful studies of cancer biology and novel therapeutic drug, imaging and device development. Methodology/Principal Findings Through this established infrastructure, the first trial of the COTC (COTC001) evaluated a targeted AAV-phage vector delivering tumor necrosis factor (RGD-A-TNF) to αV integrins on tumor endothelium. Trial progress and data was reviewed contemporaneously using a web-enabled electronic reporting system developed for the consortium. Dose-escalation in cohorts of 3 dogs (n = 24) determined an optimal safe dose (5×1012 transducing units intravenous) of RGD-A-TNF. This demonstrated selective targeting of tumor-associated vasculature and sparing of normal tissues assessed via serial biopsy of both tumor and normal tissue. Repetitive dosing in a cohort of 14 dogs, at the defined optimal dose, was well tolerated and led to objective tumor regression in two dogs (14%), stable disease in six (43%), and disease progression in six (43%) via Response Evaluation Criteria in Solid Tumors (RECIST). Conclusions/Significance The first study of the COTC has demonstrated the utility and efficiency of the established infrastructure to inform the development of new cancer drugs within large animal naturally occurring cancer models. The preclinical evaluation of RGD-A-TNF within this network provided valuable and necessary data to complete the design of first-in-man studies. PMID:19330034

  11. Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use: an overview.

    PubMed

    Petrini, Carlo

    2014-01-01

    For the 28 member states of the European Union, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, which repeals Directive 2001/20/EC, represents a substantial innovation in the procedures for authorising clinical trials and for handling all the subsequent stages. It introduces a single authorisation that will be valid for all EU member states, as well as a single portal through which all data concerning all clinical trials performed throughout the EU will pass. The present article offers an overview of the general aspects of the new procedures. It does not address the specific issues involved, each of which merits separate examination. PMID:25522070

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

    PubMed Central

    2011-01-01

    Background The prevailing view in therapeutic clinical research today is that observational studies are useful for generating new hypotheses and that controlled experiments (i.e., randomized clinical trials, RCTs) are the most appropriate method for assessing and confirming the efficacy of interventions. Discussion The current trend towards patient-centered medicine calls for alternative ways of reasoning, and in particular for a shift towards hypothetico-deductive logic, in which theory is adjusted in light of individual facts. A new model of this kind should change our approach to drug research and development, and regulation. The assessment of new therapeutic agents would be viewed as a continuous process, and regulatory approval would no longer be regarded as the final step in the testing of a hypothesis, but rather, as the hypothesis-generating step. The main role of RCTs in this patient-centered research paradigm would be to generate hypotheses, while observations would serve primarily to test their validity for different types of patients. Under hypothetico-deductive logic, RCTs are considered "exploratory" and observations, "confirmatory". Summary In this era of tailored therapeutics, the answers to therapeutic questions cannot come exclusively from methods that rely on data aggregation, the analysis of similarities, controlled experiments, and a search for the best outcome for the average patient; they must also come from methods based on data disaggregation, analysis of subgroups and individuals, an integration of research and clinical practice, systematic observations, and a search for the best outcome for the individual patient. We must look not only to evidence-based medicine, but also to medicine-based evidence, in seeking the knowledge that we need. PMID:21518440

  13. Chinese Herbal Medicine for Aspirin Resistance: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Liu, Ai-ju; Li, Hui-qin; Li, Ji-huang; Wang, Yuan-yuan; Chen, Dong; Wang, Yan

    2014-01-01

    Aspirin resistance (AR) is a prevalent phenomenon and leads to significant clinical consequences, but the current evidence for effective interventional strategy is insufficient. The objective of this systematic review is thus to assess the efficacy and safety of Chinese herbal medicine (CHM) for AR. A systematical literature search was conducted in 6 databases until December 2012 to identify randomized controlled trials (RCTs) of CHM for AR. As a result, sixteen RCTs with a total of 1011 subjects were identified, suggesting that the interests of the medical profession and the public in the use of CHM for AR have grown considerably in the recent years. Tongxinluo capsule and Danshen-based prescriptions were the most frequently used herbal prescriptions, while danshen root, milkvetch root, Leech, and Rosewood were the most frequently used single herbs. Despite the apparent reported positive findings, it is premature to determine the efficacy and safety of CHM for the treatment of AR due to poor methodological quality and insufficient safety data. However, CHMs appeared to be well tolerated in all included studies. Thus, CHM as a promising candidate is worthy of improvement and development for further clinical AR trials. Large sample-size and well-designed rigorous RCTs are needed. PMID:24701247

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

    PubMed Central

    Ugalde, Antonio

    2015-01-01

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

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

    PubMed Central

    2014-01-01

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

  16. Chinese herbal medicine for obesity: a randomized, double-blinded, multicenter, prospective trial.

    PubMed

    Zhou, Qiang; Chang, Bai; Chen, Xin-Yan; Zhou, Shui-Ping; Zhen, Zhong; Zhang, Lan-Lan; Sun, Xin; Zhou, Yuan; Xie, Wan-Qing; Liu, Hong-Fang; Xu, Yuan; Kong, Yi; Zhou, Li-Bo; Lian, Feng-Mei; Tong, Xiao-Lin

    2014-01-01

    Obesity is a serious medical problem worldwide. As a holistic therapy, traditional Chinese medicine (TCM) may have a potential in obesity management. In this controlled trial, we evaluated the safety and effectiveness of xin-ju-xiao-gao-fang (XJXGF), a TCM herbal formulation, in 140 obese subjects over a 24-week period. The XJXGF formula mainly consists of rhubarb, coptis, semen cassia, and citrus aurantium. Subjects with body mass index (BMI) 28-40 kg/m(2) were recruited at 5 centers in China. We assessed the changes in subjects' body weight, its related parameters, and the reduction of insulin resistance (IR) after administration of XJXGF formula or low-dose XJXGF (10% of the XJXGF formula, as control). After 24-week treatment, among participants in the XJXGF formula group and low-dose XJXGF group, the mean ± SE changes in the body weight were -3.58 ± 0.48 and -1.91 ± 0.38 kg, respectively (p < 0.01). The changes in the IR-index of two groups were -2.65 ± 1.04 and -1.58 ± 1.3, respectively (p < 0 .05). There were no serious adverse events reported during the 24-week trial. Participants reported 7 minor adverse events, 4 in the XJXGF formula group and 3 in the low-dose XJXGF group (p = 0.578). Future studies are needed to investigate the clinical utility of this TCM formulation in the treatment of obese subjects. PMID:25406653

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

    PubMed

    Altavilla, Annagrazia

    2011-01-01

    Clinical trials increasingly occur on a global scale as industry and government sponsors in wealthy countries move trials to low- and middle-income countries. The globalization of clinical research raises important questions about the economical and ethical aspects of clinical research and the translation of trial results to clinical practice: which ethical standards are applied? Are trials results accurate and valid, and can they be extrapolated to other settings? This article provides an overview of the strategy approved by the European Medicines Agency (EMA) to clarify ethical standards for clinical research conducted outside the European Economic Area (EEA) and included in Marketing Authorization Applications. Reference to the EMA Reflection paper is made. PMID:21409974

  18. Pre-trial beliefs in complementary and alternative medicine: whose pre-trial belief should be considered?

    PubMed

    Hansen, Kirsten; Kappel, Klemens

    2012-02-01

    Subjective probabilities play a significant role in the assessment of evidence: in other words, our background knowledge, or pre-trial beliefs, cannot be set aside when new evidence is being evaluated. Focusing on homeopathy, this paper investigates the nature of pre-trial beliefs in clinical trials. It asks whether pre-trial beliefs of the sort normally held only by those who are sympathetic to homeopathy can legitimately be disregarded in those trials. The paper addresses several surprisingly unsuccessful attempts to provide a satisfactory justification for ignoring the pre-trial beliefs of the homeopathic community. The ensuing diagnosis of the difficulties here emphasizes that the reason the arguments for choosing the pre-trial beliefs of the conventional community seem insufficient is not the arguments per se. It is rather that there is no cogent argument for choosing the conventional stance which would at the same time rationally persuade a member of the homeopathic community. The paper concludes that, once we understand that this is the predicament, there is no genuine reason to doubt the reasoning that leads us to reject the pre-trial beliefs of the homeopathic community. PMID:20820925

  19. 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

  20. Chinese Herbal Medicine in the Treatment of Chronic Heart Failure: Three-Stage Study Protocol for a Randomized Controlled Trial

    PubMed Central

    Luo, Liangtao; Chen, Jianxin; Guo, Shuzhen; Wang, Juan; Gao, Kuo; Zhang, Peng; Chen, Chan; Zhao, Huihui; Wang, Wei

    2015-01-01

    Background. Chinese herbal medicine (CHM) has been used in the treatment of chronic heart failure (CHF) for a long time. Treatment based on syndrome differentiation and the main characteristic of TCM is the fundamental principle of TCM practice. In this study protocol, we have designed a trial to assess the efficacy and safety of CHM on CHF based on syndrome differentiation. Methods/Design. This is a three-stage trial of CHM in the treatment of CHF. The first stage is a literature review aiming to explore the common syndromes of CHF. The second is a multicentral, randomized, placebo-controlled trial to evaluate the efficacy and safety of CHM for the treatment of CHF. The third is a multicentral, randomized controlled clinical trial aiming to make cost-effectiveness analysis and evaluate the feasibility, compliance, and universality of CHM on CHF. Discussion. This trial will evaluate the efficacy, safety, feasibility, compliance, and universality of CHM on CHF. The expected outcome is to provide evidence-based recommendations for CHM on CHF and develop a prescription of CHM in the treatment of CHF. This trial is registered with NCT01939236 (Stage Two of the whole trial). PMID:26089951

  1. 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. PMID:25896214

  2. 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

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

    PubMed

    Cavagnaro, Joy; Silva Lima, Beatriz

    2015-07-15

    The utility of animal models of disease for assessing the safety of novel therapeutic modalities has become an increasingly important topic of discussion as research and development efforts focus on improving the predictive value of animal studies to support accelerated clinical development. Medicines are approved for marketing based upon a determination that their benefits outweigh foreseeable risks in specific indications, specific populations, and at specific dosages and regimens. No medicine is 100% safe. A medicine is less safe if the actual risks are greater than the predicted risks. The purpose of preclinical safety assessment is to understand the potential risks to aid clinical decision-making. Ideally preclinical studies should identify potential adverse effects and design clinical studies that will minimize their occurrence. Most regulatory documents delineate the utilization of conventional "normal" animal species to evaluate the safety risk of new medicines (i.e., new chemical entities and new biological entities). Animal models of human disease are commonly utilized to gain insight into the pathogenesis of disease and to evaluate efficacy but less frequently utilized in preclinical safety assessment. An understanding of the limitations of the animal disease models together with a better understanding of the disease and how toxicity may be impacted by the disease condition should allow for a better prediction of risk in the intended patient population. Importantly, regulatory authorities are becoming more willing to accept and even recommend data from experimental animal disease models that combine efficacy and safety to support clinical development. PMID:25814257

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

    PubMed Central

    2012-01-01

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

  5. Medicines

    MedlinePlus

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

  6. Medicines

    MedlinePlus

    ... you get better. In the United States, the Food and Drug Administration is in charge of assuring ... can cause unwanted side effects or interactions with food or other medicines you may be taking. They ...

  7. Scout Launch

    NASA Technical Reports Server (NTRS)

    1961-01-01

    Scout Launch. James Hansen wrote: 'As this sequence of photos demonstrates, the launch of ST-5 on 30 June 1961 went well; however, a failure of the rocket's third stage doomed the payload, a scientific satellite known as S-55 designed for micrometeorite studies in orbit.'

  8. Randomised controlled trial of clinical decision support tools to improve learning of evidence based medicine in medical students

    PubMed Central

    Leung, Gabriel M; Johnston, Janice M; Tin, Keith Y K; Wong, Irene O L; Ho, Lai-Ming; Lam, Wendy W T; Lam, Tai-Hing

    2003-01-01

    Objective To assess the educational effectiveness on learning evidence based medicine of a handheld computer clinical decision support tool compared with a pocket card containing guidelines and a control. Design Randomised controlled trial. Setting University of Hong Kong, 2001. Participants 169 fourth year medical students. Main outcome measures Factor and individual item scores from a validated questionnaire on five key self reported measures: personal application and current use of evidence based medicine; future use of evidence based medicine; use of evidence during and after clerking patients; frequency of discussing the role of evidence during teaching rounds; and self perceived confidence in clinical decision making. Results The handheld computer improved participants' educational experience with evidence based medicine the most, with significant improvements in all outcome scores. More modest improvements were found with the pocket card, whereas the control group showed no appreciable changes in any of the key outcomes. No significant deterioration was observed in the improvements even after withdrawal of the handheld computer during an eight week washout period, suggesting at least short term sustainability of effects. Conclusions Rapid and convenient access to valid and relevant evidence on a portable computing device can improve learning in evidence based medicine, increase current and future use of evidence, and boost students' confidence in clinical decision making. PMID:14604933

  9. Recruitment and Early Retention of Women with Advanced Breast Cancer in a Complementary and Alternative Medicine Trial

    PubMed Central

    Sikorskii, Alla; Wyatt, Gwen K.; Siddiqi, Azfar-e-Alam; Tamkus, Deimante

    2011-01-01

    More than 80% of women with breast cancer are now reported to be using complementary and alternative medicine (CAM) therapies during conventional treatment. A randomized clinical trial (RCT) of reflexology with late stage breast cancer patients serves as the data source for this article. The purposes were to investigate: (i) reasons for refusal to participate in a RCT of reflexology; (ii) the differences between those who completed the baseline interview and those who dropped out before baseline; and (iii) the utility of the Palliative Prognostic Score (PPS) as a prognostic screening tool in minimizing early attrition (before baseline) from the trial. Eligible women (N = 400) approached at 12 cancer centers in the Midwest had advanced breast cancer, were on chemotherapy or hormonal therapy, and had a PPS of 11 or less. Comparisons of those who dropped out early (N = 33) to those who stayed in the trial (N = 240) were carried out using Wilcoxon rank, t-, chi-squared and Fisher's exact tests. The reasons of being “too sick” or “overwhelmed” were given by less than 12% of the women who refused to participate. There was a higher early dropout rate among black women compared to other (primarily white) women (P = .01). Cancer recurrence and metastasis, age, and the PPS were not predictive of early retention of women. Specialized techniques may be needed to ensure black women remain in the trial once consented. Women with advanced disease were likely to enter and remain in the trial despite deterioration in health. PMID:19620179

  10. Alternative therapies and medical science: designing clinical trials of alternative/complementary medicines--is evidence-based traditional Chinese medicine attainable?

    PubMed

    Critchley, J A; Zhang, Y; Suthisisang, C C; Chan, T Y; Tomlinson, B

    2000-05-01

    Evidence-based traditional Chinese medicine is attainable. With good planning and a positive attitude, the remedies used in traditional Chinese medicine (TCM) and Chinese proprietary medicines can be studied at a standard acceptable to modern science. The identification of an active principal should not delay the search for effective remedies from the TCM pharmacopoeia. Herbal mixtures can be validly tested to establish their efficacy. Problems with potential batch-to-batch variation can be circumvented by appropriate randomization. Subsequent independent screening and randomization to treatment and placebo arms can allow for the individualization of treatments by TCM practitioners. However, clearly defined treatments are required and should be recorded in a manner that enables other suitably trained researchers to reproduce them reliably (e.g., using prescriptions in Chinese). Quality control of TCM is a prerequisite of credible clinical trials. Correct natural ingredients must be used without adulteration or erroneous substitution. Evidence of safety in man is essential, and in lieu of data from formal toxicity studies, clear, convincing, and impartial evidence of safety is needed based on their long-term use in mainstream TCM practice backed up by publications in the Chinese medical/scientific literature. PMID:10806598

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

    PubMed Central

    2014-01-01

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

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

    PubMed Central

    2013-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  14. The evolution of phase I trials in cancer medicine: a critical review of the last decade.

    PubMed

    Tolcher, Anthony W

    2011-12-01

    The advent of targeted therapies, combined with an unsustainable rate of failure in oncology drug development, has resulted in a number of new approaches to clinical trials. Early clinical trials are no exception, with efforts to improve the eventual success rate of late stage trials through evolving phase I trial methodologies, the addition of extensive pharmacodynamic studies, and early adoption of patient selection strategies. Unfortunately, some of these new approaches have met with mixed results. Furthermore, no clear metrics are available to determine whether these designs are more successful than previous strategies. This review examines the evolution of phase I trials and draws upon several examples of strategies that have been successful as well as those that have not, and outlines a pragmatic approach to phase I trials as our understanding of the molecular biology of individual malignancies emerges. PMID:22059910

  15. NPP Launch

    NASA Video Gallery

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

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

    PubMed

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

    2015-12-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2014-01-01

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

  19. Effect of Combination of Chinese Herbal Medicine versus Western Medicine on Mortality in Patients after Cardiopulmonary Resuscitation: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Guo, Wenxiu; Lu, Xiaoguang; Wang, Dalong; Chen, Tuo; Fan, Zhiwei; Song, Yi

    2016-01-01

    Introduction. Although Chinese herbal medicine (CHM) treatment combined with conventional western therapy has been widely used and reported in many clinical trials in China, there is uncertainty about the efficacy of this combination in the treatment of patients after cardiopulmonary resuscitation (CPR). This systematic review aimed to assess whether the risk of mortality has decreased comparing the combination of CHM treatment with conventional western therapy. Methods. To identify relevant studies, the literature search was conducted in Medline, Embase, the Cochrane Library, CBM, CNKI, VIP, and Wanfang database. We included all randomized controlled trials (RCTs) that compared outcomes of patients after CPR taking combination of CHM treatment with those taking just conventional western therapy. Results. This meta-analysis showed that patients randomly assigned to combined CHM treatment group had a statistically significant 23% reduction in mortality compared with those randomly assigned to conventional western therapy group (RR: 0.77; 95% CI: 0.70–0.84). Conclusions. This meta-analysis provides evidence suggesting that a combined CHM therapy is associated with a decreased risk of mortality compared with conventional western therapy in patients after CPR. Further studies are needed to provide more evidence to prove or refute our conclusion and identify reasons for the reduction of mortality. PMID:26952966

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

    PubMed

    Annas; Grodin

    1996-01-01

    1996 marks the fiftieth anniversary of the commencement of the trial of Nazi physicians at Nuremberg, a trial that has been variously designated as the "Doctors' Trial" and the "Medical Case." In addition to documenting atrocities committed by physicians and scientists during WWII, the most significant contribution of the trial has come to be known as the "Nuremberg Code," a judicial codification of 10 prerequisites for the moral and legal use of human beings in experiments. Anniversaries provide us with an opportunity to reflect upon the past, but they also enable us to renew our efforts to plan for the future. This article describes briefly the historical evolution of the Nuremberg Code, discusses its current relevance and applicability by using a case study example, and proposes future steps to be taken by the international community. PMID:10393627

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

    PubMed Central

    2010-01-01

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

  2. Nanoparticle-Based Medicines: A Review of FDA-Approved Materials and Clinical Trials to Date.

    PubMed

    Bobo, Daniel; Robinson, Kye J; Islam, Jiaul; Thurecht, Kristofer J; Corrie, Simon R

    2016-10-01

    In this review we provide an up to date snapshot of nanomedicines either currently approved by the US FDA, or in the FDA clinical trials process. We define nanomedicines as therapeutic or imaging agents which comprise a nanoparticle in order to control the biodistribution, enhance the efficacy, or otherwise reduce toxicity of a drug or biologic. We identified 51 FDA-approved nanomedicines that met this definition and 77 products in clinical trials, with ~40% of trials listed in clinicaltrials.gov started in 2014 or 2015. While FDA approved materials are heavily weighted to polymeric, liposomal, and nanocrystal formulations, there is a trend towards the development of more complex materials comprising micelles, protein-based NPs, and also the emergence of a variety of inorganic and metallic particles in clinical trials. We then provide an overview of the different material categories represented in our search, highlighting nanomedicines that have either been recently approved, or are already in clinical trials. We conclude with some comments on future perspectives for nanomedicines, which we expect to include more actively-targeted materials, multi-functional materials ("theranostics") and more complicated materials that blur the boundaries of traditional material categories. A key challenge for researchers, industry, and regulators is how to classify new materials and what additional testing (e.g. safety and toxicity) is required before products become available. PMID:27299311

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

    PubMed Central

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

    2016-01-01

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

  4. "Medicine Today;" A Small Scale Trial of Subjective Responses of Doctors Viewing Television in Groups.

    ERIC Educational Resources Information Center

    Meyrick, R. L.

    The intent of this admittedly small scale and unsophisticated trial was to test the response of General Practitioners to being given a form to fill out following a television broadcast, to test the value of the semantic differential method for testing subjective responses to the programs, and to see if some means of testing by multiple-choice…

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

    PubMed Central

    2014-01-01

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

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

    PubMed

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

    2010-01-01

    The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed. PMID:19940964

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

    PubMed Central

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

    2012-01-01

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

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

    Cancer.gov

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

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

    PubMed Central

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

    2016-01-01

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

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

    Cancer.gov

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

  11. Acellular approaches for regenerative medicine: on the verge of clinical trials with extracellular membrane vesicles?

    PubMed

    Fuster-Matanzo, Almudena; Gessler, Florian; Leonardi, Tommaso; Iraci, Nunzio; Pluchino, Stefano

    2015-01-01

    Extracellular vesicles (EVs) are a heterogeneous population of naturally occurring secreted small vesicles, with distinct biophysical properties and different functions both in physiology and under pathological conditions. In recent years, a number of studies have demonstrated that EVs might hold remarkable potential in regenerative medicine by acting as therapeutically promising nanodrugs. Understanding their final impact on the biology of specific target cells as well as clarification of their overall therapeutic impact remains a matter of intense debate. Here we review the key principles of EVs in physiological and pathological conditions with a specific highlight on the most recently described mechanisms regulating some of the EV-mediated effects. First, we describe the current debates and the upcoming research on EVs as potential novel therapeutics in regenerative medicine, either as unmodified agents or as functionalized small carriers for targeted drug delivery. Moreover, we address a number of safety aspects and regulatory limitations related to the novel nature of EV-mediated therapeutic applications. Despite the emerging possibilities of EV treatments, these issues need to be overcome in order to allow their safe and successful application in future explorative clinical studies. PMID:26631254

  12. [Surrogate end points for clinical trials on chronic kidney disease and research of Chinese medicine].

    PubMed

    Rao, Xiang-rong; Wang, Li; Dai, Xi-wen

    2008-08-01

    Chronic kidney disease is a kind of disease with the condition always worsening over time passing through a sequence of stages, and the evaluation on its clinical treatment is mainly by observing the speed of renal function deteriorating and the time of terminal renal failure occurrence. In order to conduct the trial go on wheels, the authors proposed that the "surrogate end points (SEP)" should be introduced. It is the biologic mark for substitute the clinical terminal point (event), formed depending upon the scientific evidences of epidemiology, pathophysiology, drug-therapy and other scientific evidence, which could be used for predicting the efficacy or damage of a certain measure, present or absent. This article aimed to explain the definition of SEP and to discuss the usable SEP for clinical trial on chronic kidney disease, such as proteinuria, declination of glomerular filtration rate and its slope coefficient as well as the time of terminal occurrence. Moreover, through analyzing the existent problems in clinical researches concerning TCM treatment of chronic kidney disease, the authors suggested that some improvements, chiefly the utilization of SEP for efficacy evaluation, are necessary in the clinical observation methodologies for chronic kidney disease. PMID:18928108

  13. Ethical Considerations for Acupuncture and Chinese Herbal Medicine Clinical Trials: A Cross-cultural Perspective.

    PubMed

    Zaslawski, Christopher

    2010-09-01

    MANY ETHICAL CONCERNS REVOLVE AROUND THE FOUR BASIC PRINCIPLES OF RESEARCH: merit and integrity, respect for human beings, weighting of risk-benefit and justice. These principles form the basis for any discussion concerning human research ethics and are applicable to all areas of research including acupuncture and Chinese herbal medicine. World Health Organisation document, Guidelines for Clinical Research on Acupuncture, states that 'consideration should be given to the different value systems that are involved in human rights such as social, cultural and historical issues' and that 'further studies should be conducted in relation to ethical issues involved in clinical research on acupuncture'. In addition to outlining the four basic principles, this paper will also examine the effect of Asian culture on Western human research ethics and how this may impact upon issues such as informed consent and weighting of risk-benefit. PMID:18955359

  14. The reporting quality, scientific rigor, and ethics of randomized placebo-controlled trials of traditional Chinese medicine compound formulations and the differences between Chinese and non-Chinese trials

    PubMed Central

    Zhong, Yun-Qing; Fu, Juan-Juan; Liu, Xue-Mei; Diao, Xiang; Mao, Bing; Fan, Tao; Yang, Hong-Mei; Liu, Guan-Jian; Zhang, Wen-Bin

    2010-01-01

    Background: An increasing number of randomized placebo-controlled trials involving traditional Chinese medicine (TCM) compound formulations have been implemented worldwide. Objective: The aim of this study was to assess the reporting quality, scientific rigor, and ethics of randomized placebo-controlled trials of TCM compound formulations and compare these differences between Chinese and non-Chinese trials. Methods: English-language databases included the following: PubMed, OVID, EMBASE, and Science Citation Index Expanded. Chinese-language databases included the following: Chinese Biomedical Literature Database, Wanfang Database, Chinese Scientific and Technological Periodical Database, and the China National Knowledge Infrastructure. All were searched from respective inception to March 2009 to identify randomized placebo-controlled trials involving TCM compound prescriptions. Two reviewers independently assessed the retrieved trials via a modified Consolidated Standard of Reporting Trials (CONSORT) checklist and some evaluation indices that embodied the TCM characteristics or the scientific rigor and ethics of placebo-controlled trials. Trial publishing time was divided into 3 intervals: phase 1 (≤1999); phase 2 (2000–2004); and phase 3 (2005–2009). The number and percentage of trials reporting each item and the corresponding differences between Chinese (mainland China, Hong Kong, and Taiwan) and non-Chinese (eg, Japan, United States, Australia, Korea, and United Kingdom) trials were calculated. Moreover, the influence of trial publishing time on the reporting of CONSORT items and the differences in the number of items reported for each time interval between Chinese and non-Chinese trials were assessed. Results: A total of 324 trials from China and 51 trials from other countries were included. A mean of 39.7% of the CONSORT items across all Chinese trials and 50.2% of the items across all non-Chinese trials were reported. The number of the reported CONSORT

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

    PubMed

    Sun, X D; Zhu, H

    2016-02-01

    Accompany with dramatically growth of large-scale biological databases (such as human genome sequence), improvement of life science and development of international clinical trials, science offers great potential for improving health care through precision medicine. As a hot topic recently, precision medicine might launch a revolution of the methodology in medical research. How to achieve precision medicine in clinical ophthalmology by means of biological data mining is a challenge for ophthalmologist-scientists. The best approach for advanced individual medicine is to buildup the digital ophthalmology, which includes human eye biobank, national biological databases network, clinical department, basic research lab, and international clinical trial center. The system of digital ophthalmology could explore the methods for ophthalmology research, integrate the source of eye biologic databases, promote international cooperation, and thus eventually supply the opportunity for translational medicine. PMID:26906701

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

    PubMed Central

    2014-01-01

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

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

    PubMed

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

    2007-08-01

    Cannabis sativa L. has been utilized for treatment of pain and sleep disorders since ancient times. This review examines modern studies on effects of Delta9-tetrahydrocannabinol (THC) and cannabidiol (CBD) on sleep. It goes on to report new information on the effects on sleep in the context of medical treatment of neuropathic pain and symptoms of multiple sclerosis, employing standardized oromucosal cannabis-based medicines containing primarily THC, CBD, or a 1 : 1 combination of the two (Sativex). Sleep-laboratory results indicate a mild activating effect of CBD, and slight residual sedation with THC-predominant extracts. Experience to date with Sativex in numerous Phase I-III studies in 2000 subjects with 1000 patient years of exposure demonstrate marked improvement in subjective sleep parameters in patients with a wide variety of pain conditions including multiple sclerosis, peripheral neuropathic pain, intractable cancer pain, and rheumatoid arthritis, with an acceptable adverse event profile. No tolerance to the benefit of Sativex on pain or sleep, nor need for dosage increases have been noted in safety extension studies of up to four years, wherein 40-50% of subjects attained good or very good sleep quality, a key source of disability in chronic pain syndromes that may contribute to patients' quality of life. PMID:17712817

  18. Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis.

    PubMed

    Collin, C; Davies, P; Mutiboko, I K; Ratcliffe, S

    2007-03-01

    Symptoms relating to spasticity are common in multiple sclerosis (MS) and can be difficult to treat. We have investigated the efficacy, safety and tolerability of a standardized oromucosal whole plant cannabis-based medicine (CBM) containing delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD), upon spasticity in MS. A total of 189 subjects with definite MS and spasticity were randomized to receive daily doses of active preparation (n = 124) or placebo (n = 65) in a double blind study over 6 weeks. The primary endpoint was the change in a daily subject-recorded Numerical Rating Scale of spasticity. Secondary endpoints included a measure of spasticity (Ashworth Score) and a subjective measure of spasm. The primary efficacy analysis on the intention to treat (ITT) population (n = 184) showed the active preparation to be significantly superior (P = 0.048). Secondary efficacy measures were all in favour of active preparation but did not achieve statistical significance. The responder analysis favoured active preparation, 40% of subjects achieved >30% benefit (P = 0.014). Eight withdrawals were attributed to adverse events (AEs); six were on active preparation and two on placebo. We conclude that this CBM may represent a useful new agent for treatment of the symptomatic relief of spasticity in MS. PMID:17355549

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

    PubMed Central

    2013-01-01

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

  20. Systems medicine in colorectal cancer: from a mathematical model toward a new type of clinical trial.

    PubMed

    Castagnino, Nicoletta; Maffei, Massimo; Tortolina, Lorenzo; Zoppoli, Gabriele; Piras, Daniela; Nencioni, Alessio; Moran, Eva; Ballestrero, Alberto; Patrone, Franco; Parodi, Silvio

    2016-07-01

    Current colorectal cancer (CRC) treatment guidelines are primarily based on clinical features, such as cancer stage and grade. However, outcomes may be improved using molecular treatment guidelines. Potentially useful biomarkers include driver mutations and somatically inherited alterations, signaling proteins (their expression levels and (post) translational modifications), mRNAs, micro-RNAs and long noncoding RNAs. Moving to an integrated system is potentially very relevant. To implement such an integrated system: we focus on an important region of the signaling network, immediately above the G1-S restriction point, and discuss the reconstruction of a Molecular Interaction Map and interrogating it with a dynamic mathematical model. Extensive model pretraining achieved satisfactory, validated, performance. The model helps to propose future target combination priorities, and restricts drastically the number of drugs to be finally tested at a cellular, in vivo, and clinical-trial level. Our model allows for the inclusion of the unique molecular profiles of each individual patient's tumor. While existing clinical guidelines are well established, dynamic modeling may be used for future targeted combination therapies, which may progressively become part of clinical practice within the near future. WIREs Syst Biol Med 2016, 8:314-336. doi: 10.1002/wsbm.1342 For further resources related to this article, please visit the WIREs website. PMID:27240214

  1. Prospective Molecular Profiling of Canine Cancers Provides a Clinically Relevant Comparative Model for Evaluating Personalized Medicine (PMed) Trials

    PubMed Central

    Mazcko, Christina; Cherba, David; Hendricks, William; Lana, Susan; Ehrhart, E. J.; Charles, Brad; Fehling, Heather; Kumar, Leena; Vail, David; Henson, Michael; Childress, Michael; Kitchell, Barbara; Kingsley, Christopher; Kim, Seungchan; Neff, Mark; Davis, Barbara

    2014-01-01

    Background Molecularly-guided trials (i.e. PMed) now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting. Methodology A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC) to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77%) successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days). Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type. Conclusions Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (<1 week). Clustering data show robust signatures by cancer type but also showed patient-to-patient heterogeneity in drug predictions. This lends further support to the inclusion of a heterogeneous population of dogs with cancer

  2. Loading of Launch Vehicle when Launching from Floating Launch Platform

    NASA Astrophysics Data System (ADS)

    Agarkov, A. V.; Pyrig, V. A.

    2002-01-01

    equator, which is a most effective way from payload capability standpoint. But mobility of the Launch Platform conditions an increase in LV loading as compared with onground launch. Therefore, to provide efficiency of lounching from LP requires solving certain issues to minimize LV loading at launch processing. The paper at hand describes ways to solve these issues while creating and operating the international space launch system Sea Launch, which provides commercial spacecraft launches onboard Zenit-3SL launch vehicle from the floating launch platform located at the equator in the Pacific. Methods to decrease these loads by selecting the optimum position of LP and by correcting LP trim and heel were described. In order to account for impact of weather changing (i.e. waves and winds) and launch support operations on the launch capability, a system of predicted load calculation was designed. By measuring LP roll and pitch parameters as well as wind speed and direction, the system defines loading at LV root section, compares it with the allowable value and, based on the compavision, forms a conclusion on launch capability. launches by Sea Launch.

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

    PubMed

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

    2016-04-01

    Shaofu Zhuyu decoction (SFZY) or Sobokchugeo-tang, a traditional herbal formula, is used as a treatment for primary dysmenorrhea. We searched four English, seven Korean, three Chinese, and one Japanese database from inception through January 2016 without a language restriction. All randomized controlled trials (RCTs) of SFZY or modified SFZY (MSFZY) were included. Data extraction and risk of bias assessments were performed by two independent reviewers. A total of 51 potentially relevant studies were identified, and 9 RCTs met our inclusion criteria. Seven RCTs tested the effects of SFZY or modified SFZY in treating dysmenorrhea. Three RCTs showed superior effects of (M)SFZY on the response rate, while the other three RCTs failed to do so (n=531, RR: 1.17, 95% CI: 1.09 to 1.26, P<0.0001, I(2)=0%). Three RCTs showed favorable effects of MSFZY for pain reduction compared with conventional drugs (n=340, SMD: -1.39, 95% CI: -2.23 to -0.55, P=0.01). Two RCTs examined the effects of modified SFZY plus conventional drugs and conventional drugs alone. The meta-analysis showed favorable effects of MSFZY (n=206; RR, 1.12; 95% CI 1.08 to 1.36; P=0.0009, I(2)=0%). Our systemic review and meta-analysis provide suggestive evidence of the superiority of SFZY over conventional drugs for treating primary dysmenorrhea. However, the level of evidence is low because of a high risk of bias. PMID:26921931

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

    2011-01-01

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

  6. Chinese Herbal Medicine for Myelosuppression Induced by Chemotherapy or Radiotherapy: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Jia, Youji; Du, Huihui; Yao, Min; Cui, Xuejun; Shi, Qi; Wang, Yongjun; Yang, Yanping

    2015-01-01

    Background. Myelosuppression is one of the major side effects of chemo- and radiotherapy in cancer patients and there are no effective interventions to prevent it currently. Chinese herbal medicine (CHM) may be helpful due to its multidrug targets. Objectives. This study was designed to evaluate effectiveness of CHM on preventing patients from experiencing myelosuppression by chemo- or radiotherapy. Search Methods. Randomized controlled trials (RCTs) were retrieved from seven different databases from the date of database creation to April 2014. We assessed all included studies using Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 and performed statistical analysis using RevMan 5.2.1. Results. Eight RCTs were included (818 patients). Pooled data showed that increase of white blood cells (WBCs) is higher with CHM plus chemotherapy/radiotherapy than with chemotherapy/radiotherapy only. Both CHM compared to placebo and CHM combined with chemotherapy/radiotherapy compared to chemotherapy/radiotherapy lacked significant differences in the peripheral platelets, red blood cells (RBCs), and hemoglobin changes. Conclusions. Our results demonstrated that CHM significantly protected peripheral blood WBCs from a decrease caused by chemotherapy or radiotherapy. There were no significant protective effects on peripheral RBCs, hemoglobin, or platelets, which may be related to low quality and small sample of included studies. PMID:25802542

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

    PubMed

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

    2012-08-01

    The herbal medicine, maoto, has been traditionally prescribed to patients with influenza in Japan. To better understand the efficacy of maoto for the treatment of influenza, a randomized trial was conducted for comparison with oseltamivir or zanamivir. Adult patients with influenza symptoms, including fever, positive for quick diagnostic kit for influenza within 48 h of fever onset were assessed for enrollment. The data of 28 patients randomly assigned to maoto (n = 10), oseltamivir (n = 8), or zanamivir (n = 10) were analyzed for the duration of fever (>37.5°C) and total symptom score from symptom cards recorded by the patient. Viral isolation and serum cytokine measurements were also done on days 1, 3, and 5. Maoto granules, a commercial medical dosage form, are made from four plants: Ephedra Herb, Apricot Kernel, Cinnamon Bark, and Glycyrrhiza Root. Median durations of fever of patients assigned maoto, oseltamivir, or zanamivir were 29, 46, or 27 h, respectively, significantly different for maoto and oseltamivir. No significant between-group differences were found in total symptom score among three groups. Viral persistent rates and serum cytokine levels (IFN-α, IL-6, IL-8, IL-10, and TNF-α) during the study period showed no differences among three groups. The administration of oral maoto granules to healthy adults with seasonal influenza was well tolerated and associated with equivalent clinical and virological efficacy to neuraminidase inhibitors. PMID:22350323

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

    ERIC Educational Resources Information Center

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

    2013-01-01

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

  9. Complementary medicine.

    PubMed

    Ernst, E

    2003-03-01

    Complementary medicine has become an important subject for rheumatologists, not least because many patients try complementary treatments. Recent clinical trials yield promising results. In particular, evidence suggests that several herbal medicines and dietary supplements can alleviate the pain of osteoarthritis and rheumatoid arthritis. Clearly, rigorous testing of complementary treatments is possible, and considering their popularity, should be encouraged. PMID:12598804

  10. 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 Central

    2014-01-01

    Background 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. Methods/design 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. Discussion It is hypothesized that each of

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

    PubMed Central

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

    2013-01-01

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

  12. 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.

  13. Chinese Medicinal Herbs in the Treatment of Upper Airway Cough Syndrome: A Systematic Review of Randomized, Controlled Trials.

    PubMed

    Jiang, Hongli; Liu, Wei; Li, Guanhong; Fan, Tao; Mao, Bing

    2016-03-01

    Context • Upper airway cough syndrome (UACS), previously called postnasal drip syndrome (PNDS), has been considered universally to be one of the most common causes of chronic cough. As an important part of complementary and alternative therapy, traditional Chinese medicine (TCM) has found an exact curative therapy for chronic cough through clinical practice for thousands of years. Objective • The aim of the current review was to investigate systematically the beneficial and adverse effects of Chinese medicinal herbs (CMH) in the treatment of UACS. Design • The research team performed searches in 11 main databases from respective inception to October 31, 2015, supplemented with manual retrieval of other data. Only randomized, controlled trials (RCTs) reporting on the effectiveness of CMH in patients with UACS were included. Descriptive and quantitative data on the studies' designs, population demographics, interventions, outcomes, and methodological quality were extracted and tabulated. Methodological quality was assessed using the Cochrane risk-of-bias system and the quality of the evidence was evaluated using the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) system. Participants • The reviewed studies included 1355 participants-720 in the CMH groups and 635 in the control groups-of both genders, from various professional and ethnic groups, and with a wide range of ages. They all had a duration of cough symptoms of longer than 8 wk and a clinical diagnosis of chronic cough induced by UACS that was supported by appropriate physical findings. Outcome Measures • The primary outcomes included (1) TCM recovery rate and (2) TCM cough symptom score. TCM's curative effect was calculated as the cumulative percentage of the symptom-score reduction (PSSR), estimated between baseline and postintervention. The cough symptom scores were graded according to the Chinese Criteria Guiding Principle of Clinical Research on New Drugs of TCM, with

  14. 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

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

    PubMed Central

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

    2016-01-01

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

  16. Assessment of the Reporting Quality of Placebo-controlled Randomized Trials on the Treatment of Type 2 Diabetes With Traditional Chinese Medicine in Mainland China

    PubMed Central

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

    2016-01-01

    Abstract 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

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

    PubMed Central

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

    2016-01-01

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

  18. 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

  19. 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.

  20. IRIS Launch Animation

    NASA Video Gallery

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

  1. Shuttle Era: Launch Directors

    NASA Video Gallery

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

  2. Space Launch System Animation

    NASA Video Gallery

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

  3. Effect of Combining Therapy with Traditional Chinese Medicine-Based Psychotherapy and Herbal Medicines in Women with Menopausal Syndrome: A Randomized Controlled Clinical Trial

    PubMed Central

    Yang, Hongyan; Yang, Jing; Wen, Zehuai; Zha, Qinglin; Nie, Guangning; Huang, Xuchun; Zhang, Chunlin; Lu, Aiping; Jiang, Miao; Wang, Xiaoyun

    2012-01-01

    This multicenter, randomized, controlled clinical study was designed to address the effectiveness of combined traditional-Chinese-medicine- (TCM-) based psychotherapy and Chinese herbal medicine (CHM) in the treatment of menopausal syndrome. Altogether 424 eligible women diagnosed as menopausal syndrome and categorized as Kidney-Yin/Kidney-Yang deficiency pattern in TCM were randomly assigned into 4 groups and accepted TCM-based psychotherapy (PSY), CHM, PSY + CHM, or placebo therapies, respectively, for 12 weeks, and another 12 weeks were taken as the followup. Kupperman Index (KI) and the Menopause-Specific Quality of Life (MENQOL) with its four subscales (vasomotor, physical, psychosocial, and sexual) were employed for efficacy assessment. Results showed that 400 participants completed 12-week treatment, of which 380 finished the record of KI and MENQOF at week 24. The average adjusted number of KI score decreased between baseline and 12 weeks in all groups. Statistically significant differences were detected in the average adjusted change between the PSY + CHM group and placebo at overall time points (P < 0.05). No severe adverse events occurred in each group and no significant differences were indicated between any of the three groups and placebo in adverse event proportion. We concluded that TCM psychotherapy combined with CHM has a favorable outcome in treating menopausal syndrome. PMID:23304198

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Launch operations efficiency

    NASA Technical Reports Server (NTRS)

    Diloreto, Clem; Fischer, Carl; Atkins, Bob

    1988-01-01

    The paper discusses launch operations from a program perspective. Launch operations cost is a significant part of program cost. New approaches to launch operations, integrated with lessons learned, have the potential to increase safety and reliability as well as reduce cost. Operational efficiency must be an initial program goal. Design technology and management philosophy must be implemented early to ensure operational cost goals. Manufacturing cost and launch cost are related to operational efficiency. True program savings can be realized through implementation of launch operations cost saving approaches which do not correspondingly increase cost in other program areas such as manufacturing and software development and maintenance. Launch rate is a key factor in the cost/flight analysis and the determination of launch operations efficiency goals.

  10. 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.

  11. The key role of Shenyan Kangfu tablets, a Chinese patent medicine for diabetic nephropathy: study protocol for a randomized, double-blind and placebo-controlled clinical trial

    PubMed Central

    2013-01-01

    Background Diabetic nephropathy (DN) is a major microvascular complication with diabetes. In China, an estimated 34.7 percent of people diagnosed with diabetes have renal complications and a further 50 percent die of renal failure. Hence, identification of alternative treatments for these patients should be given priority. The Shenyan Kangfu tablet (SYKFT) is a new formulation of an existing and widely acclaimed Chinese herbal tea for treating qi-yin deficiency syndrome. Because a considerable portion of DN patients presenting with symptoms of swelling, fatigue and weak limbs would be diagnosed with qi-yin deficiency syndrome according to the traditional Chinese medicine (TCM) diagnostic criteria, we hypothesize that SYKFT may represent a complementary drug for DN patients with the corresponding syndrome. In view of this, we have designed a trial to assess the efficacy and safety of SYKFT for patients with diabetic nephropathy exhibiting signs of qi and yin deficiency. Methods This is a multicenter, double-blind, randomized controlled trial (RCT). The total target sample size is planned at 80 participants, with a balanced (1:1) treatment allocation. The experimental intervention will be SYKFY plus irbesartan (SI regimen) and the control intervention will be a placebo plus irbesartan (PI regimen). Participants will receive two courses of medication treatment each lasting 8 weeks. The primary outcome will be the composite of the quantitative 24-hour urinary protein level and urinary albumin excretion rate (UAER). Changes in urine albumin-to-creatinine ratio (UACR) and DN staging, and TCM symptom improvement will be the secondary outcome measures. Adverse events (AEs) will be monitored throughout the trial. Discussion This study will be the first placebo-controlled RCT to assess whether SYKFT plus irbesartan will have beneficial effects on enhancing overall response rate (ORR), changing DN staging, improving clinical symptoms, and reducing the frequency of AEs for DN

  12. 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

  13. Launch facilities as infrastructure

    NASA Astrophysics Data System (ADS)

    Trial, Mike

    The idea is put forth that launch facilities in the U.S. impose inefficiencies on launch service providers due to the way they have been constructed. Rather than constructing facilities for a specific program, then discarding them when the program is complete, a better use of the facilities investment would be in constructing facilities flexible enough for use by multiple vehicle types over the course of a 25-year design lifetime. The planned National Launch System (NLS) program offers one possible avenue for the federal government to provide a nucleus of launch infrastructure which can improve launch efficiencies. The NLS goals are to develop a new space launch system to meet civil and national needs. The new system will be jointly funded by DOD and NASA but will actively consider commercial space needs. The NLS will improve reliability, responsiveness, and mission performance, and reduce operating costs. The specifics of the infrastructure concept are discussed.

  14. Evaluating the evidence for evidence-based medicine: are randomized clinical trials less flawed than other forms of peer-reviewed medical research?

    PubMed

    Steen, R Grant; Dager, Stephen R

    2013-09-01

    Evidence-based medicine considers randomized clinical trials (RCTs) to be the strongest form of evidence for clinical decision making. To test the hypothesis that RCTs have fewer methodological flaws than non-RCTs, limitations of 17,591 RCTs and 39,029 non-RCTs were characterized. Panels of experts assembled to write meta-analyses evaluated this literature to determine which articles should be included in 316 meta-analytic reviews. Overall, 38.7% of RCTs evaluated were excluded from review for an identified flaw. Commonly identified flaws in RCTs were as follows: insufficient data provided to evaluate the study (9.6% of 17,591 RCTs); inadequate randomization (9.0%); inadequate blinding (4.9%); and duplicative publication (4.4%). Overall, 20.2% of all published medical research has an identified methodological flaw, with RCTs having as many limitations as non-RCTs. PMID:23695156

  15. What We Have Learned About Trial of Labor After Cesarean Delivery from the Maternal-Fetal Medicine Units Cesarean Registry.

    PubMed

    Landon, Mark B; Grobman, William A

    2016-08-01

    The cesarean delivery rate in the United States has risen steadily over the past 5 decades such that approximately one in three women now undergo cesarean section. The rise in repeat operations and accompanying decline in trial of labor after cesarean (TOLAC) have been major contributors to this phenomenon. The appropriate use of TOLAC continues to be a topic of interest with the recognition that most women with a history of prior cesarean are candidates for trial of labor. The NICHD MFMU Network Cesarean Registry conducted from 1999 to 2002 provided contemporary data concerning the risks and benefits of TOLAC, which in turn have helped inform practitioners and women considering their options for childbirth following cesarean delivery. PMID:27210023

  16. Liuwei Dihuang Pills Enhance the Effect of Western Medicine in Treating Diabetic Nephropathy: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Lin, Lan; Wang, Qiuhong; Yi, Yongxin; Wang, Shihan; Qiu, Zonglin

    2016-01-01

    Objectives. To assess the effectiveness and adverse effects of adding Liuwei Dihuang Pills (LDP) to Western medicine for treating diabetic nephropathy. Methods. Studies were retrieved from seven electronic databases, including PubMed, Embase, The Cochrane Library, CBM, CNKI, Chinese Scientific Journal Database (VIP), and Wanfang Data until November 2015. Study selection, data extraction, quality assessment, and data analyses were conducted according to Cochrane standards. Meta-analysis was performed on the overall therapeutic efficacy of hyperglycemia and renal functions, and the study also analyzed adverse events. Results. A total of 1,275 patients from 18 studies were included. The methodological quality of these included trials was generally low. We found that adding LDP can lower patients' FBG (MD: −0.36 [−0.46, −0.25], P < 0.00001), PBG (MD: −1.10 [−1.35, −0.85], P < 0.00001), and HbA1c (MD: −0.14 [−0.49, 0.21], P = 0.43). There were also improvements in lowering patients' BUN (MD: −0.67 [−0.89, −0.45], P < 0.00001), SCr (MD: −0.96 [−1.53, −0.39], P < 0.00001), 24 h UTP (SMD: −1.26 [−2.38, −0.15], P < 0.00001), UAER (MD: −26.18 [−27.51, −24.85], P < 0.00001), and UmAlb (SMD: −1.72 [−2.67, −0.77], P < 0.00001). Conclusion. There is encouraging evidence that adding LDP to Western medicine might improve treatment outcomes of diabetic nephropathy, including hyperglycemia and renal functions. However, the evidence remains weak. More rigorous high-quality trials are warranted to substantiate or refute the results. PMID:26997962

  17. 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

  18. GPM: Waiting for Launch

    NASA Video Gallery

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

  19. Kestrel balloon launch system

    SciTech Connect

    Newman, M.J.

    1991-10-01

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

  20. Is Marijuana Medicine?

    MedlinePlus

    ... Publications » DrugFacts » Is Marijuana Medicine? DrugFacts: Is Marijuana Medicine? Email Facebook Twitter Revised July 2015 What is ... isn’t the marijuana plant an FDA-approved medicine? The FDA requires carefully conducted studies (clinical trials) ...

  1. Comparison between Chinese Herbal Medicines and Conventional Therapy in the Treatment of Severe Hand, Foot, and Mouth Disease: A Randomized Controlled Trial

    PubMed Central

    Li, Xiuhui; Zhang, Xi; Ding, Jianbo; Xu, Yi; Wei, Dan; Tian, Yimei; Chen, Wei; Huang, Jihan; Li, Shuangjie

    2014-01-01

    Background. This study was made to evaluate the efficacy of Chinese herbal medicines, Reduning injection, and a traditional Chinese medicine (TCM) granule, in patients with severe hand, foot, and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial. Methods. 355 severe HFMD patients were randomly assigned to receive conventional therapy alone, Reduning injection plus conventional therapy, or TCM enema plus conventional therapy for 7–10 days. Results. There was no significant difference in the incidence of major complications between the groups. Median time to fever clearance was 20 hours (95% CI: 6.0–25.0) for conventional therapy recipients, 18 hours (95% CI: 4.0–24.0) for Reduning combination-treated patients, and 6 hours (95% CI: 4.0–16.0) for TCM combination-treated patients. Only the difference in time to fever clearance between TCM combination group and conventional group reached statistical significance (P = 0.048). Reduning combination group showed a significant reduction in sedative administration compared with conventional therapy group (P = 0.008). No HFMD-related death and no important adverse events were observed. Conclusions. Reduning injection plus conventional therapy significantly reduced the concomitant use of sedatives, which may help decrease HFMD-related neurologic complications in children. TCM effectively reduced time to fever clearance and may become a complementary therapy for relieving the symptoms of severe HFMD. PMID:24719639

  2. Comparison between Chinese Herbal Medicines and Conventional Therapy in the Treatment of Severe Hand, Foot, and Mouth Disease: A Randomized Controlled Trial.

    PubMed

    Li, Xiuhui; Zhang, Xi; Ding, Jianbo; Xu, Yi; Wei, Dan; Tian, Yimei; Chen, Wei; Huang, Jihan; Wen, Tao; Li, Shuangjie

    2014-01-01

    Background. This study was made to evaluate the efficacy of Chinese herbal medicines, Reduning injection, and a traditional Chinese medicine (TCM) granule, in patients with severe hand, foot, and mouth disease (HFMD) by conducting a prospective, controlled, and randomized trial. Methods. 355 severe HFMD patients were randomly assigned to receive conventional therapy alone, Reduning injection plus conventional therapy, or TCM enema plus conventional therapy for 7-10 days. Results. There was no significant difference in the incidence of major complications between the groups. Median time to fever clearance was 20 hours (95% CI: 6.0-25.0) for conventional therapy recipients, 18 hours (95% CI: 4.0-24.0) for Reduning combination-treated patients, and 6 hours (95% CI: 4.0-16.0) for TCM combination-treated patients. Only the difference in time to fever clearance between TCM combination group and conventional group reached statistical significance (P = 0.048). Reduning combination group showed a significant reduction in sedative administration compared with conventional therapy group (P = 0.008). No HFMD-related death and no important adverse events were observed. Conclusions. Reduning injection plus conventional therapy significantly reduced the concomitant use of sedatives, which may help decrease HFMD-related neurologic complications in children. TCM effectively reduced time to fever clearance and may become a complementary therapy for relieving the symptoms of severe HFMD. PMID:24719639

  3. Effectiveness of an additional individualized multi-component complementary medicine treatment on health-related quality of life in breast cancer patients: a pragmatic randomized trial.

    PubMed

    Witt, Claudia M; Außerer, Oskar; Baier, Susanne; Heidegger, Herbert; Icke, Katja; Mayr, Oswald; Mitterer, Manfred; Roll, Stephanie; Spizzo, Gilbert; Scherer, Arthur; Thuile, Christian; Wieser, Anton; Schützler, Lena

    2015-01-01

    The aim of this study was to evaluate the effectiveness of an additional, individualized, multi-component complementary medicine treatment offered to breast cancer patients at the Merano Hospital (South Tyrol) on health-related quality of life compared to patients receiving usual care only. A randomized pragmatic trial with two parallel arms was performed. Women with confirmed diagnoses of breast cancer were randomized (stratified by usual care treatment) to receive individualized complementary medicine (CM group) or usual care alone (usual care group). Both groups were allowed to use conventional treatment for breast cancer. Primary endpoint was the breast cancer-related quality of life FACT-B score at 6 months. For statistical analysis, we used analysis of covariance (with factors treatment, stratum, and baseline FACT-B score) and imputed missing FACT-B scores at 6 months with regression-based multiple imputation. A total of 275 patients were randomized between April 2011 and March 2012 to the CM group (n = 136, 56.3 ± 10.9 years of age) or the usual care group (n = 139, 56.0 ± 11.0). After 6 months from randomization, adjusted means for health-related quality of life were higher in the CM group (FACT-B score 107.9; 95 % CI 104.1-111.7) compared to the usual care group (102.2; 98.5-105.9) with an adjusted FACT-B score difference between groups of 5.7 (2.6-8.7, p < 0.001). Thus, an additional individualized and complex complementary medicine intervention improved quality of life of breast cancer patients compared to usual care alone. Further studies evaluating specific effects of treatment components should follow to optimize the treatment of breast cancer patients. PMID:25555830

  4. The challenge to bring personalized cancer medicine from clinical trials into routine clinical practice: the case of the Institut Gustave Roussy.

    PubMed

    Arnedos, Monica; André, Fabrice; Farace, Françoise; Lacroix, Ludovic; Besse, Benjamin; Robert, Caroline; Soria, Jean Charles; Eggermont, Alexander M M

    2012-04-01

    Research with high throughput technologies has propitiated the segmentation of different types of tumors into very small subgroups characterized by the presence of very rare molecular alterations. The identification of these subgroups and the apparition of new agents targeting these infrequent alterations are already affecting the way in which clinical trials are being conducted with an increased need to identify those patients harboring specific molecular alterations. In this review we describe some of the currently ongoing and future studies at the Institut Gustave Roussy that aim for the identification of potential therapeutic targets for cancer patients with the incorporation of high throughput technologies into daily practice including aCGH, next generation sequencing and the creation of a software that allows for target identification specific for each tumor. The initial intention is to enrich clinical trials with cancer patients carrying certain molecular alterations in order to increase the possibility of demonstrating benefit from a targeted agent. Mid and long term aims are to facilitate and speed up the process of drug development as well as to implement the concept of personalized medicine. PMID:22483534

  5. Chinese Medicines as an Adjuvant Therapy for Unresectable Hepatocellular Carcinoma during Transarterial Chemoembolization: A Meta-Analysis of Randomized Controlled Trials

    PubMed Central

    Wang, Xuanbin; Yuen, Man-Fung; Ziea, Tat-chi; Tong, Yao; Wong, Vivian Taam; Feng, Yibin

    2013-01-01

    Objective. To conduct a comprehensive PRISMA-compliant systematic review and meta-analysis to evaluate the efficacy and safety of Chinese medicines (CMs) as an adjuvant therapy for unresectable HCC during transarterial chemoembolization (TACE). Methods. Main databases were searched up to October 2012 for randomized controlled trials (RCTs) evaluating the effects of CMs plus TACE on unresectable HCC compared with TACE alone. References of relevant reviews and eligible studies were also assessed. Risk ratios with 95% confidence intervals and mean difference were calculated. Heterogeneity and publication bias were examined. Results. Sixty-seven trials (N = 5,211) were included in the meta-analysis. Sensitivity analysis and random-effects model were performed for assessing significant heterogeneity. CMs plus TACE showed beneficial effects on tumor response, survival at 6, 12, 18, 24, and 36 months, quality of life, and TACE toxicity reduction compared with TACE alone. Conclusion. The results show that the use of CMs may increase the efficacy and reduce the toxicity of TACE in treating patients with unresectable HCC. These findings suggest that CMs could be considered as an adjuvant therapy for unresectable HCC patients during TACE. Larger-scale RCTs using standard methods and long-term follow-up are warranted to confirm these findings. PMID:23956773

  6. Four-year analysis of cardiovascular disease risk factors, depression symptoms, and antidepressant medicine use in the Look AHEAD (Action for Health in Diabetes) clinical trial of weight loss in diabetes

    Technology Transfer Automated Retrieval System (TEKTRAN)

    OBJECTIVE To study the association of depressive symptoms or antidepressant medicine (ADM) use with subsequent cardiovascular disease (CVD) risk factor status in the Look AHEAD (Action for Health in Diabetes) trial of weight loss in type 2 diabetes. RESEARCH DESIGN AND METHODS Participants (n = 5,1...

  7. The experience of “medicine companions” to support adherence to antiretroviral therapy: quantitative and qualitative data from a trial population in Uganda

    PubMed Central

    Foster, S.D.; Nakamanya, S.; Kyomuhangi, R.; Amurwon, J.; Namara, G.; Amuron, B.; Nabiryo, C.; Birungi, J.; Wolff, B.; Jaffar, S.; Grosskurth, H.

    2010-01-01

    Good adherence is critical for antiretroviral therapy (ART) in sub-Saharan Africa. We report on the characteristics of medicine companions (MCs) chosen by Ugandan patients enrolling on ART, and on how MCs were chosen, and what roles they played. Baseline data on MCs of 1453 participants in a randomized controlled trial comparing facility and home-based delivery of ART in Jinja, Uganda were analyzed. Textual data on experience with MCs were collected through in-depth interviews among a subsample of 40 trial participants equally divided by sex and trial arm. Significantly more women (71%) than men (29%) were recruited. The majority (75%) of women participants were either widowed (51%) or separated or divorced (24%), whereas most of the men (66%) were married. Women were most likely to choose a child as their MC while men were most likely to choose their spouse; 41% of women chose an MC under 21 compared with only 14% of men. Only 31% of married women chose their husband, compared with 66% of married men who chose their wife. Qualitative interviews suggested MCs proved useful for reminding and other supportive tasks in the first three months but were generally less essential by six months and beyond. Convenience, reliability, and trust were key considerations in choosing an MC. Children provided the only alternative for many unmarried women, but even some married women felt children made more reliable MCs than husbands. Participants who had disclosed their serostatus usually received drug-taking reminders from multiple household members. One participant in the qualitative sample with poor family relations delayed starting treatment due to unwillingness to identify an MC. MCs were generally welcome and useful in supporting early adherence. However, disclosure to an MC should not be a condition of obtaining treatment. PMID:20680859

  8. Multicentre, randomised, placebo-controlled trial of extract of Japanese herbal medicine Daikenchuto to prevent bowel dysfunction after adult liver transplantation (DKB 14 Study)

    PubMed Central

    Kaido, Toshimi; Shimamura, Tsuyoshi; Sugawara, Yasuhiko; Sadamori, Hiroshi; Shirabe, Ken; Yamamoto, Michio; Uemoto, Shinji

    2015-01-01

    Introduction This multicentre randomised controlled clinical trial will aim to determine the ability of an extract (TJ-100) of Daikenchuto (traditional Japanese herbal medicine; Kampo) to prevent bowel dysfunction in at least 110 patients after liver transplantation (LT). Methods and analysis The following co-primary end points will be evaluated on postoperative day 7: total oral and enteral caloric intake, abdominal distension and abdominal pain. The secondary end points will comprise sequential changes of total oral and enteral caloric intake after LT, sequential changes in numeric rating scales for abdominal distension and pain, elapsed time to the first postoperative passage of stool, quality of life assessment using the Gastrointestinal Symptom Rating Scale score (Japanese version), postoperative liver function, liver regeneration rate, incidence of bacteraemia and bacterial strain, trough level of immunosuppressants, occurrence of acute cellular rejection, discharge or not within 2 months after LT, sequential changes of portal venous flow to the graft and ascites discharge. The two arms of the study will comprise 55 patients per arm. Ethics and dissemination The study has been conducted according to the CONSORT statement. All participants signed a written consent form, and the study has been approved by the institutional review board of each participating institute and conducted in accordance with the Declaration of Helsinki of 1996. The findings will be disseminated through scientific and professional conferences, and in peer-reviewed journals. Trial registration number The DKB 14 Study was registered in the University Hospital Medical Information Network Clinical Trial Registration (UMIN-CTR), Japan (registration number: UMIN000014326) during 2014. PMID:26419681

  9. Chinese Herbal Medicine and Fluorouracil-Based Chemotherapy for Colorectal Cancer: A Quality-Adjusted Meta-Analysis of Randomized Controlled Trials.

    PubMed

    McCulloch, Michael; Ly, Helen; Broffman, Michael; See, Caylie; Clemons, Jen; Chang, Raymond

    2016-09-01

    Background Chinese herbal medicines reportedly increase efficacy and minimize toxicity of chemotherapy; however, little attention has been paid to how poor study quality can bias outcomes. Methods We systematically searched MEDLINE, TCMLARS, EMBASE, and Cochrane Library for randomized controlled trials of Chinese herbal medicines combined with fluorouracil-based chemotherapy compared with the same chemotherapy alone. We screened for eligibility, extracted data, and pooled data with random-effects meta-analysis. Outcome measures were survival, toxicity, tumor response, performance status, quality of life, and Cochrane Risk of Bias (ROB) criteria to critically evaluate the quality of reporting in the randomized trials included in the meta-analysis. Results We found 36 potentially eligible studies, with only 3 (those with low ROB) qualifying for meta-analysis. Two reported chemotherapy-related diarrhea reduced by 57% (relative risk [RR] = 0.43; 95% CI = 0.19-1.01; I(2) test for variation in RR due to heterogeneity = 0.0%), with nonsignificant results. Two reported white blood cell toxicity reduced by 66% (RR = 0.34; 95% CI = 0.16-0.72; I(2) test for variation in RR due to heterogeneity = 0.0%), with statistically significant results. Stratifying analysis by studies with high versus low ROB, we found substantial overestimation of benefit: Studies with high ROB overestimated by nearly 2-fold reduction of platelet toxicity by Chinese herbal medicines (RR = 0.35, 95% CI = 0.15-0.84 vs RR = 0.65, 95% CI = 0.11-3.92). Studies with high ROB overestimated by nearly 2-fold reduction of vomiting toxicity (RR = 0.45, 95% CI = 0.33-0.61 vs RR = 0.87, 95% CI = 0.48-1.58). And, studies with high ROB overestimated by 21% the reduction in diarrhea toxicity (RR = 0.34, 95% CI = 0.20-0.58 vs RR = 0.43, 95% CI = 0.19-1.01). Studies with high ROB also overestimated by 16% improvement in tumor response (RR = 1.39, 95% CI = 1.18-1.63 vs RR = 1.20; 95% CI = 0.81-1.79). Not accounting for

  10. Will the EU Clinical Trials Regulation Support the Innovative Industry in Bringing New Medicines Faster to Patients?

    PubMed

    Atzor, Sabine; Gokhale, Surendra; Doherty, Michael

    2013-04-01

    A perspective from the innovative industry is provided in this article about the long awaited legal proposal for a Clinical Trial Regulation ("Proposal"), adopted in July 2012. With this Proposal, the European Commission reacted to a call by all stakeholders for more harmonization and streamlining of the provisions for conducting clinical trials in the EU. Discrepant approaches between Member States, a failure to respect legal timelines, and a lack of formal coordination mechanisms within and between Member States have resulted in an increased workload for the industry and contributed to a decline in Europe's attractiveness as a place to carry out research and development. The Proposal introduces a concept whereby the sponsor makes a single submission of the clinical trial application dossier to an EU portal, which is followed by a single assessment based on cooperation between Member States. A possibility for the sponsor to choose a 'reporting Member State' to take the lead on key aspects of the assessment is expected to support excellence building and work sharing of Competent Authorities in the EU. The Proposal respects the fact that certain aspects need to be reviewed nationally. The new process aims to lead to a single decision per clinical trial per concerned Member State. The rules are built on the principle of strict adherence to timelines for authorization. The timelines are ambitious but at the same time competitive, as the process builds in mechanisms that strengthen compliance. The rules have been designed to encourage sponsors to file complete submission packages, since any substantial modification to a trial would lead to delays in its commencement. Sponsors need to streamline their internal processes accordingly. In the end, streamlining is an effort that needs to be accepted by all parties involved. The Proposal does not detail how Member States organize the involvement of different bodies, such as Competent Authorities and Ethics Committees

  11. Herbal medicine (Gan Mai Da Zao decoction) for depression: a systematic review and meta-analysis of randomized controlled trials.

    PubMed

    Jun, Ji Hee; Choi, Tae-Young; Lee, Ju Ah; Yun, Kyung-Jin; Lee, Myeong Soo

    2014-12-01

    The objective of this review was to analyze the trial data on the efficacy and safety of Gan Mai Da Zao (GMDZ) decoction for depression. PubMed, the Cochrane Library, and EMBASE, AMED, Korea Med, DBPIA, OASIS, RISS, KISS, CNKI, Wan Fang Database, and VIP were searched through to May 2014. Randomized controlled trials (RCTs) testing GMDZ decoction for any type of depression were considered. All RCTs of GMDZ decoction or modified GMDZ decoction were included. Data were extracted by 2 independent reviewers. Meta-analysis was used for the pooled data. A total of 298 potentially relevant studies were identified, and 13 RCTs met our inclusion criteria. All of the included RCTs had a high risk of bias across their domains. Three RCTs failed to show favorable effects of GMDZ decoction on response rate or HAMD score in major depression. One RCT showed a beneficial effect of GMDZ decoction on response rate in post-surgical depression, while another failed to do so. Two studies showed favorable effects on response rate in post-stroke depression, while another two failed to do so. A meta-analysis, however, showed that GMDZ decoction produced better response rates than anti-depressants in post-stroke depression (RR: 1.17, I(2)=15%). One trial failed to show any beneficial effects of GMDZ decoction on response rate or HAMD score in depression in an elderly sample. Two trials tested GMDZ decoction in combination with anti-depressants but failed to show effects on response rate in major depression, while another did show beneficial effects on response rate in post-stroke depression. In summary, our systematic review and meta-analysis failed to provide evidence of the superiority of GMDZ decoction over anti-depressant therapies for major depression, post-surgical depression, or depression in the elderly, although there was evidence of an effect in post-stroke depression. The quality of evidence for this finding was low, however, because of a high risk of bias. PMID:25262476

  12. 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.

  13. 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.

  14. Clinical trials of medicines in neonates: the influence of ethical and practical issues on design and conduct

    PubMed Central

    Turner, Mark A

    2015-01-01

    In the past, there has been a perception that ethical and practical problems limit the opportunities for research in neonates. This perception is no longer appropriate. It is now clear that research about the medicines used in neonates is an ethical requirement. It is possible to conduct high quality research in neonates if the research team adapt to the characteristics of this population. Good practice involves respecting the specific needs of newborn babies and their families by adopting relevant approaches to study design, recruitment, pharmacokinetic studies and safety assessment. Neonatal units have a unique culture that requires careful development in a research setting. Clinical investigators need to recognize the clinical and ethical imperative to conduct rigorous research. Industry needs to engage with neonatal networks early in the process of drug development, preferably before contacting regulatory agencies. Follow-up over 3–5 years is essential for the evaluation of medicines in neonates and explicit funding for this is required for the assessment of the benefit and risk of treatments given to sick newborn babies. The views of parents must be central to the development of studies and the research agenda. Ethical and practical problems are no longer barriers to research in neonates. The current challenges are to disseminate good practice and maximize capacity in order to meet the need for research among newborn babies. PMID:25041601

  15. 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.

  16. NASA launch schedule

    NASA Astrophysics Data System (ADS)

    Bell, Peter M.

    The National Aeronautics and Space Administration (NASA) has a record-setting launch schedule for 1984—10 space shuttle flights (see Table 1), 10 satellite deployments from the space shuttle in orbit and 12 unmanned missions using expendable launch vehicles. Also scheduled is the launch on March 1 for the National Oceanic and Atmospheric Administration of Landsat D‧, the nation's second earth resources satellite.The launch activity will begin February 3 with the launch of shuttle mission 41-B using the orbiter Challenger. Two communications satellites will be deployed from 41-B: Westar-VI, for Western Union, and Palapa B-2 for the government of Indonesia. The 8-day mission will feature the first shuttle landing at Kennedy Space Center in Florida; and the first flight of the Manned Maneuvering Unit, a self-contained, propulsive backpack that will allow astronauts to move about in space without being tethered to the spacecraft.

  17. Wrongful termination: lessons from the Geron clinical trial.

    PubMed

    Scott, Christopher Thomas; Magnus, David

    2014-12-01

    Geron Corporation is a publically traded company that launched a phase I clinical trial of a human embryonic stem cell-based therapy for spinal cord injury. The company enrolled the first patient in October 2010 and stopped the trial 1 year later. The fifth patient had been enrolled but not transplanted when the company announced the trial's end. After discussions with clinical staff and family, an agreement was reached to add her to the cohort and proceed with the transplant. Two and half years later, the research is still waiting to restart. With this background in mind, we discuss the major ethical and social questions raised by the Geron case. We offer recommendations for institutional review boards and clinical sites as they deliberate approvals of early-phase trials in frontier medicine. PMID:25298371

  18. GMP facilities for manufacturing of advanced therapy medicinal products for clinical trials: an overview for clinical researchers.

    PubMed

    Alici, Evren; Blomberg, Pontus

    2010-12-01

    To be able to produce advanced therapy medicinal products, compliance with regulatory standards while maintaining flexibility is mandatory. For this purpose, careful planning is vital in the design or upgrade of a facility. Similarly, extensive foresight is elemental to anticipate upcoming needs and requirements. Failing this may lead to the facility's in-ability to meet the demands. In this chapter we aimed to outline the current issues with regards to the European Union Directives (EUD) and the proposal for Advanced Therapies, which are of importance to cellular and gene therapy facilities in Europe. This chapter is an attempt to elucidate what the minimum requirements for GMP facilities for cell and gene therapy products are and what is considered necessary to comply with the regulations in Europe. PMID:21054243

  19. 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

  20. THE BIG PICTURE ON SMALL MEDICINE: THE STATE OF NANOMEDICINE PRODUCTS APPROVED FOR USE OR IN CLINICAL TRIALS

    PubMed Central

    Etheridge, Michael L.; Campbell, Stephen A.; Erdman, Arthur G.; Haynes, Christy L.; Wolf, Susan M.; McCullough, Jeffrey

    2015-01-01

    Developments in nanomedicine are expected to provide solutions to many of modern medicine’s unsolved problems, so it is no surprise that literature is flush with articles discussing the subject. However, existing reviews tend to focus on specific sectors of nanomedicine or take a very forward looking stance and fail to provide a complete perspective on the current landscape. This article provides a more comprehensive and contemporary inventory of nanomedicine products. A keyword search of literature, clinical trial registries, and the Web, yielded 247 nanomedicine products that are approved or in various stages of clinical study. Specific information on each was gathered, so the overall field could be described based on various dimensions, including: FDA classification, approval status, nanoscale size, treated condition, nanostructure, and others. In addition to documenting the large number of nanomedicine products already in human use, this study indentifies some interesting trends forecasting the future of nanomedicine. PMID:22684017

  1. 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

  2. STS-51 Launch

    NASA Technical Reports Server (NTRS)

    1993-01-01

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

  3. Hi-C Launch

    NASA Video Gallery

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

  4. Commercial space launches

    NASA Astrophysics Data System (ADS)

    Robb, David W.

    1984-04-01

    While the space shuttle is expected to be the principle Space Transportation System (STS) of the United States, the Reagan Administration is moving ahead with the President's declared space policy of encouraging private sector operation of expendable launch vehicles (ELV's). With the signing of the “Commercial Space Launch Law” on October 30, the administration hopes that it has opened up the door for commercial ventures into space by streamlining regulations and coordinating applications for launches. The administration considers the development and operation of private sector ELV's as an important part of an overall U.S. space policy, complementing the space shuttle and government ELV's. The law follows by nearly a year the creation of the Office of Commercial Space Transportation at the U.S. Department of Transportation (DOT), which will coordinate applications for commercial space launches.

  5. GPM Launch Coverage

    NASA Video Gallery

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

  6. Advanced launch system

    NASA Technical Reports Server (NTRS)

    Monk, Jan C.

    1991-01-01

    The Advanced Launch System (ALS) is presented. The costs, reliability, capabilities, infrastructure are briefly described. Quality approach, failure modes, structural design, technology benefits, and key facilities are outlined. This presentation is represented by viewgraphs.

  7. Expedition 27 Launch

    NASA Video Gallery

    NASA astronaut Ron Garan and Russian cosmonauts Andrey Borisenko and Alexander Samokutyaev launch in their Soyuz TMA-21 spacecraft from the Baikonur Cosmodrome in Kazakhstan on April 4, 2011 (April...

  8. Genomic Data Commons launches

    Cancer.gov

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

  9. NASA Now: Glory Launch

    NASA Video Gallery

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

  10. Launch of Juno!

    NASA Video Gallery

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

  11. IRVE 3 Launch

    NASA Video Gallery

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

  12. Teaching Evidence-Based Complementary and Alternative Medicine (EBCAM); Changing behaviours in the face of reticence: A cross-over trial

    PubMed Central

    Mills, Edward; Hollyer, Taras; Saranchuk, Ron; Wilson, Kumanan

    2002-01-01

    Background The effectiveness of teaching critical appraisal to students of Complementary and Alternative Medicine (CAM) has not been studied. In this study we attempt to determine if a workshop for final year students at a naturopathic college improved their ability to utilize critical appraisal concepts. Methods We assigned 83 Naturopathic Interns to two groups: Group A (n = 47) or Group B (n = 36). We conducted a baseline assessment of all subjects' critical appraisal skills. Group A was assigned to receive a 3 ½ hour workshop on Evidence Based Medicine (EBM) and Group B received a workshop on bioethics (control intervention). The groups critical appraisal skills were re-evaluated at this time. We then crossed over the intervention so that Group B received the EBM workshop while Group A received the bioethics workshop. Assessment of critical appraisal skills of the two groups was again performed. Results The students mean scores were similar in Group A (14.8) and Group B (15.0) after Group A had received the intervention and Group B had received the control (p = 0.75). Group scores were not significantly improved at the end of the trial compared to at the beginning of the study (Group A: 15.1 to 16.1) (Group B 15.6 to 15.9). Student's confidence in reading research papers also did not improve throughout the course of the study. Conclusion The final year is a difficult but important time to teach critical appraisal and evidence skills. Single, short intervention programs will likely yield negligible results. A multi-factorial approach may be better suited to implementing EBCAM than single short interventions. PMID:11818036

  13. IMPACT - Integrative Medicine PrimAry Care Trial: protocol for a comparative effectiveness study of the clinical and cost outcomes of an integrative primary care clinic model

    PubMed Central

    2014-01-01

    Background Integrative medicine (IM) is a patient-centered, healing-oriented clinical paradigm that explicitly includes all appropriate therapeutic approaches whether they originate in conventional or complementary medicine (CM). While there is some evidence for the clinical and cost-effectiveness of IM practice models, the existing evidence base for IM depends largely on studies of individual CM therapies. This may in part be due to the methodological challenges inherent in evaluating a complex intervention (i.e., many interacting components applied flexibly and with tailoring) such as IM. Methods/Design This study will use a combination of observational quantitative and qualitative methods to rigorously measure the health and healthcare utilization outcomes of the University of Arizona Integrative Health Center (UAIHC), an IM adult primary care clinic in Phoenix, Arizona. There are four groups of study participants. The primary group consists of clinic patients for whom clinical and cost outcomes will be tracked indicating the impact of the UAIHC clinic (n = 500). In addition to comparing outcomes pre/post clinic enrollment, where possible, these outcomes will be compared to those of two matched control groups, and for some self-report measures, to regional and national data. The second and third study groups consist of clinic patients (n = 180) and clinic personnel (n = 15-20) from whom fidelity data (i.e., data indicating the extent to which the IM practice model was implemented as planned) will be collected. These data will be analyzed to determine the exact nature of the intervention as implemented and to provide covariates to the outcomes analyses as the clinic evolves. The fourth group is made up of patients (n = 8) whose path through the clinic will be studied in detail using qualitative (periodic semi-structured interviews) methods. These data will be used to develop hypotheses regarding how the clinic works. Discussion The US health care

  14. STS-64 launch view

    NASA Technical Reports Server (NTRS)

    1994-01-01

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

  15. Dynamics Explorer launch

    NASA Technical Reports Server (NTRS)

    1981-01-01

    Simultaneously launched from the WSMC, two satellites are to be placed into polar, copolar orbit in order to acquire data on the coupling phenomena between Earth's lower thermosphere and the magnetosphere, as part of the Solar-Terrestrial Program. The mission sequence, instruments, and science data processing system are described as well as the characteristics of the Delta 3913 launch vehicle, and payload separation staging.

  16. Evaluating the Individualized Treatment of Traditional Chinese Medicine: A Pilot Study of N-of-1 Trials

    PubMed Central

    Xue, Jingjing; Tang, Jie; Ding, Liyu; Ma, Ying; Wang, Jie; Guyatt, Gordon H.

    2014-01-01

    Purpose. To compare the efficacy of individualized herbal decoction with controlled decoction for individual patients with stable bronchiectasis. Methods. We conducted N-of-1 RCTs (single-patient, double-blind, randomized, multiple crossover design) in 3 patients with stable bronchiectasis. The primary outcome was patient self-rated symptom scores on visual analogue scales. Secondary outcome was 24-hour sputum volume. A clinical efficacy criterion which combined symptoms score and medication preference was also formulated. Results. All three patients showed various degrees of improvement on their symptoms and one patient's (Case 3) 24 h sputum volume decreased from 70 mL to 30 mL. However, no significant differences were found between individualized herbal decoction and control decoction on symptoms score, or on 24-hour sputum volume. One patient (Case 2) had clear preference for the individualized herbal decoction over the standard one with the confirmation after unblinding. We therefore considered this case as clinically important. Discussion. N-of-1 trials comply with individualized philosophy of TCM clinical practice and had good compliance. It is necessary to set up clinical efficacy criteria and to consider the interference of acute exacerbation. PMID:25477988

  17. Huge Data-Sharing Project Launched.

    PubMed

    Rose, Suzanne

    2016-01-01

    Aiming to advance precision medicine in oncology and improve patient care, the American Association for Cancer Research has launched an international initiative known as AACR Project Genomics, Evidence, Neoplasia, Information, Exchange (GENIE). The venture will pool existing and future next-generation clinical sequencing data with longitudinal clinical outcomes and related pathology reports from several institutions in the United States, Canada, and Europe, to find new mutations, assess potential biomarkers, and identify patient populations that might benefit from existing treatments. PMID:26546297

  18. Laboratory and field trial of developing medicinal local Thai plant products against four species of mosquito vectors.

    PubMed

    Trongtokit, Yuwadee; Rongsriyam, Yupha; Komalamisra, Narumon; Krisadaphong, Panvipa; Apiwathnasorn, Chamnarn

    2004-06-01

    Oils of Syzygium aromaticum (clove) and Zanthoxylum limonella (makaen), widely used essential oils for dental caries or flavoring of food in Thailand, were prepared as 10 experimental repellent products in gel or cream form against Aedes aegypti, Culex quinquefasciatus, and Anopheles dirus under laboratory conditions, using the human-arm-in-cage method. Two products that gave the longest-lasting complete protection were selected to examine their repellency against a variety of mosquito species under field conditions. In laboratory tests, 0.1 g of each product was applied to 3x10 cm of exposed area on a volunteer's forearm, while in field trials, 1.0 g was applied to each volunteer's leg (from knee to ankle). In the laboratory, the gel dosage form contained 20% clove oil (Gel B) or 10% clove plus 10% makaen oil mixture (Gel E) were promising plant-based repellents against three mosquito species and gave significantly longer complete protection times of 4-5 hours than all other developing products. Therefore, their efficacy in the field was evaluated. Under field conditions, Gel E showed complete protection for 4 hours and gave 95.7% repellency after 5 hours application, whereas Gel B and 20% deet (di-methyl benzamide) provided only 86.8 and 82.7% repellency after treatment, respectively against Ae. aegypti, daytime-biting mosquitos. For nighttime-biting, the 3 repellents under development yielded equally excellent (average 97.1%) repellency for 5 hours against the predominant Cx. quinquefasciatus and Mansonia uniformis, but they gave 89.0% repellency against Cx. tritaeniorhynchus and Cx. gelidus. This finding demonstrated the effectiveness of Gel B and Gel E products for possible use by low-income rural communities against various mosquito species. PMID:15691131

  19. Self-Monitoring of Blood Pressure for Improving Adherence to Antihypertensive Medicines and Blood Pressure Control: A Randomized Controlled Trial

    PubMed Central

    Hosseininasab, Masumeh; Jahangard-Rafsanjani, Zahra; Mohagheghi, Abbas; Sarayani, Amir; Rashidian, Arash; Javadi, Mohammadreza; Ahmadvand, Alireza; Hadjibabaie, Molouk

    2014-01-01

    BACKGROUND Self-monitoring is reported to have limited efficacy for hypertension management in high-income countries. In this study, we aimed to evaluate the effect of self-monitoring on blood pressure (BP) control in an Iranian population. METHODS A randomized controlled trial was conducted on 196 mild to moderate hypertensive patients in an outpatient cardiovascular clinic. Patients in the intervention group received a wrist self-monitoring device and were educated to measure and document their BP daily during the study period (24 weeks). Patients in the control group received usual care. Three follow-up visits with the physician were scheduled for all patients (weeks 4, 12, and 24), and the investigator assessed adherence to medications after each visit (pill counting). The primary outcome (BP) was compared between groups using repeated-measure analysis of variance. RESULTS One hundred ninety patients completed the study. Systolic BP (144.4±7.4 vs 145.9±6.4mm Hg) and diastolic BP (85.5±6.9 vs. 85.1±7.7mm Hg) were similar between groups at baseline. The trend of BP was not significantly different between groups during the study period. Systolic and diastolic BP decreased significantly in both groups at the first follow-up visit (systolic BP: 132.6 vs. 133.4mm Hg; diastolic BP: 77.4 vs. 77.2mm Hg). In the intervention group, we observed a small continued decrease in diastolic BP up to week 24 BP (P = 0.01). Both groups showed adherence rates >95% during the study period. CONCLUSIONS Our study could not confirm that self-monitoring can improve BP control in patients with frequent medical visits. PMID:24771706

  20. Medicinal clays improve the endurance of loaded inspiratory muscles in COPD: a randomized clinical trial of nonpharmacological treatment

    PubMed Central

    Baldi, Simonetta; Pinna, Gian Domenico; Bruschi, Claudio; Caldara, Fabrizio; Maestri, Roberto; Dacosto, Elena; Rezzani, Antonella; Popovich, Ermanno; Bellinzona, Ezio; Crotti, Paola; Montemartini, Silvia; Fracchia, Claudio

    2015-01-01

    Background Inspiratory resistive breathing (IRB) challenges affect respiratory muscle endurance in healthy individuals, which is considered to be an interleukin 6 (IL-6)–dependent mechanism. Whether nonpharmacological thermal therapies promote the endurance of loaded inspiratory muscles in chronic obstructive pulmonary disease (COPD) is unclear. The objectives of this study were to compare the effects of two thermal interventions on endurance time (ET) and plasma IL-6 concentration following an IRB challenge. Methods This study was a randomized, parallel-group, unblinded clinical trial in a single-center setting. Forty-two patients (aged 42–76 years) suffering from mild to severe COPD participated in this study. Both groups completed 12 sessions of the mud bath therapy (MBT) (n=22) or leisure thermal activity (LTA) (n=19) in a thermal spa center in Italy. Pre- and postintervention spirometry, maximum inspiratory pressure, and plasma mediators were obtained and ET and endurance oxygen expenditure (VO2Endur) were measured following IRB challenge at 40% of maximum inspiratory pressure. Results There was no difference in ΔIL-6 between the intervention groups. But, IRB challenge increased cytokine IL-6 plasma levels systematically. The effect size was small. A statistically significant treatment by IRB challenge effect existed in ET, which significantly increased in the MBT group (P=0.003). In analysis of covariance treatment by IRB challenge analysis with LnVO2Endur as the dependent variable, ΔIL-6 after intervention predicted LnVO2Endur in the MBT group, but not in the LTA group. Adverse events occurred in two individuals in the MBT group, but they were mainly transient. One patient in the LTA group dropped out. Conclusion MBT model improves ET upon a moderate IRB challenge, indicating the occurrence of a training effect. The LnVO2Endur/ΔIL-6 suggests a physiologic adaptive mechanism in respiratory muscles of COPD patients allocated to treatment. Both thermal

  1. GPM Core Observatory Launch Animation

    NASA Video Gallery

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

  2. Additive Effect of Qidan Dihuang Grain, a Traditional Chinese Medicine, and Angiotensin Receptor Blockers on Albuminuria Levels in Patients with Diabetic Nephropathy: A Randomized, Parallel-Controlled Trial

    PubMed Central

    Xiang, Lei; Jiang, Pingping; Zhou, Lin; Sun, Xiaomin; Bi, Jianlu; Cui, Lijuan; Nie, Xiaoli; Luo, Ren; Liu, Yanyan

    2016-01-01

    Albuminuria is characteristic of early-stage diabetic nephropathy (DN). The conventional treatments with angiotensin receptor blockers (ARB) are unable to prevent the development of albuminuria in normotensive individuals with type 2 diabetes mellitus (T2DM). Purpose. The present study aimed to evaluate the effect of ARB combined with a Chinese formula Qidan Dihuang grain (QDDHG) in improving albuminuria and Traditional Chinese Medicine Symptom (TCMS) scores in normotensive individuals with T2DM. Methods. Eligible patients were randomized to the treatment group and the control group. Results. Compared with baseline (week 0), both treatment and control groups markedly improved the 24-hour albuminuria, total proteinuria (TPU), and urinary albumin to creatinine ratio (A/C) at 4, 8, and 12 weeks. Between treatment and the control group, the levels of albuminuria in the treatment group were significantly lower than in the control group at 8 and 12 weeks (p < 0.05). In addition, treatment group markedly decreased the scores of TCMS after treatment. Conclusion. This trial suggests that QDDHG combined with ARB administration decreases the levels of albuminuria and the scores for TCMS in normotensive individuals with T2DM. PMID:27375762

  3. Use of short message service reminders to improve attendance at an internal medicine outpatient clinic in Saudi Arabia: a randomized controlled trial.

    PubMed

    Youssef, A

    2014-05-01

    Non-attendance at outpatient appointments is a major problem. This study aimed to evaluate the efficacy of sending short message service (SMS) reminders to patients' mobile phones in reducing non-attendance at scheduled appointments. A randomized clinical trial was conducted in 2011 in an internal medicine outpatient clinic at a hospital in Eastern Province, Saudi Arabia. Eligible patients (n = 502) were randomly allocated to receive an SMS reminder of their appointment (intervention group) or no reminder (control group). The non-attendance rate was significantly lower in the reminder group (26.3%) than the non-reminder group (39.8%). In multivariate logistic regression, age, sex and nationality did not affect attendance rates but having their first contact with the hospital (OR = 7.40) and not receiving an SMS reminder (OR = 0.56) were significant factors in non-attendance. All patients surveyed about their perceptions of the SMS reminder (n = 76) reported they would like to continue to receive SMS reminders in the future. PMID:24952289

  4. National Farm Medicine Center

    MedlinePlus

    Research Areas Applied Sciences Biomedical Informatics Clinical Research Epidemiology Farm Medicine Human Genetics Oral-Systemic Health Clinical Trials Services CM&R Research Lab Research Compliance Research Integrity & ...

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

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

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

  6. Filling the launch gap

    NASA Astrophysics Data System (ADS)

    Hoeser, S.

    1986-05-01

    Vehicles proposed to fill the gap in the U.S. space program's space transport needs for the next decade resulting from the January Challenger disaster, are discussed. Prior to the accident, the Air Force planned to purchase a Complementary Expendable Launch Vehicle system consisting of 10 single-use Titan-34D7 rockets. Another heavy lift booster now considered is the Phoenix H. Commercial launch vehicle systems projected to be available in the necessary time frame include the 215,000-pound thrust 4000-pound LEO payload capacity NASA Delta, the 11,300-pound LEO payload capacity Atlas Centaur the first ICBM, and the all-solid propellant expendable 2000-pound LEO payload Conestoga rocket. Also considered is the man-rated fully reusable Phoenix vertical take-off and vertical-landing launch vehicle.

  7. Zvezda Launch Coverage

    NASA Technical Reports Server (NTRS)

    2000-01-01

    Footage shows the Proton Rocket (containing the Zvezda module) ready for launch at the Baikonur Cosmodrome in Kazakhstan, Russia. The interior and exterior of Zvezda are seen during construction. Computerized simulations show the solar arrays deploying on Zvezda in space, the maneuvers of the module as it approaches and connects with the International Space Station (ISS), the installation of the Z1 truss on the ISS and its solar arrays deploying, and the installations of the Destiny Laboratory, Remote Manipulator System, and Kibo Experiment Module. Live footage then shows the successful launch of the Proton Rocket.

  8. Juno II Launch Vehicle

    NASA Technical Reports Server (NTRS)

    1958-01-01

    The modified Jupiter C (sometimes called Juno I), used to launch Explorer I, had minimum payload lifting capabilities. Explorer I weighed slightly less than 31 pounds. Juno II was part of America's effort to increase payload lifting capabilities. Among other achievements, the vehicle successfully launched a Pioneer IV satellite on March 3, 1959, and an Explorer VII satellite on October 13, 1959. Responsibility for Juno II passed from the Army to the Marshall Space Flight Center when the Center was activated on July 1, 1960. On November 3, 1960, a Juno II sent Explorer VIII into a 1,000-mile deep orbit within the ionosphere.

  9. STS-64 launch view

    NASA Technical Reports Server (NTRS)

    1994-01-01

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

  10. 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.

  11. Efficacy and safety of the Chinese herbal medicine shuganjieyu with and without adjunctive repetitive transcranial magnetic stimulation (rTMS) for geriatric depression: a randomized controlled trial

    PubMed Central

    XIE, Minmin; JIANG, Wenhai; YANG, Haibo

    2015-01-01

    Background Pharmacological treatment of geriatric depression is often ineffective because patients cannot tolerate adequate doses of antidepressant medications. Aim Examine the efficacy and safety of shuganjieyu – the first Chinese herbal medicine approved for the treatment of depression by China’s drug regulatory agency -- with and without adjunctive treatment with repetitive transcranial magnetic stimulation (rTMS) in the treatment of geriatric depression. Methods Sixty-five inpatients 60 or older who met ICD-10 criteria for depression were randomly assigned to an experimental group (shuganjieyu + rTMS) (n=36) or a control group (shuganjieyu + sham rTMS)(n=29). All participants received 4 capsules of shuganjieyu daily for 6 weeks. rTMS (or sham rTMS) was administered 20 minutes daily, five days a week for 4 weeks. Blinded raters used the Hamilton Rating Scale for Depression (HAMD-17) and the Treatment Emergent Symptom Scale to assess clinical efficacy and safety at baseline and 1, 2, 4, and 6 weeks after starting treatment. Over the six-week trial, there was only one dropout from the experimental group and two dropouts from the control group. Results None of the patients had serious side effects, but 40% in the experimental group and 50% in the control group experienced minor side effects that all resolved spontaneously. Both groups showed substantial stepwise improvement in depressive symptoms over the 6 weeks. Repeated measures ANOVA found no differences between the two groups. After 6 weeks, 97% of the experimental group had experienced a 25% or greater drop in the level of depression, but only 20% had experience a 50% or greater drop in the level of depression; the corresponding values in the control group were 96% and 19%. There were some minor, non-significant differences in the onset of the treatment effect between the different types of depressive symptoms, but by the second week of treatment all five HAMD-17 subscale scores had improved significantly

  12. National Library of Medicine

    MedlinePlus

    ... U.S. National Library of Medicine Search Contact NLM Databases PubMed/MEDLINE MeSH UMLS ClinicalTrials.gov MedlinePlus TOXNET ... History of Medicine Digital Collections LocatorPlus All NLM Databases & APIs Please turn on Javascript For an enhanced ...

  13. Wrongful Termination: Lessons From the Geron Clinical Trial

    PubMed Central

    Magnus, David

    2014-01-01

    SUMMARY Geron Corporation is a publically traded company that launched a phase I clinical trial of a human embryonic stem cell-based therapy for spinal cord injury. The company enrolled the first patient in October 2010 and stopped the trial 1 year later. The fifth patient had been enrolled but not transplanted when the company announced the trial’s end. After discussions with clinical staff and family, an agreement was reached to add her to the cohort and proceed with the transplant. Two and half years later, the research is still waiting to restart. With this background in mind, we discuss the major ethical and social questions raised by the Geron case. We offer recommendations for institutional review boards and clinical sites as they deliberate approvals of early-phase trials in frontier medicine. PMID:25298371

  14. NLS Advanced Development - Launch operations

    NASA Technical Reports Server (NTRS)

    Parrish, Carrie L.

    1992-01-01

    Attention is given to Autonomous Launch Operations (ALO), one of a number of the USAF's National Launch System (NLS) Launch Operations projects whose aim is to research, develop and apply new technologies and more efficient approaches toward launch operations. The goal of the ALO project is to develop generic control and monitor software for launch operation subsystems. The result is enhanced reliability of system design, and reduced software development and retention of expert knowledge throughout the life-cycle of the system.

  15. Launch Vehicle Description

    NASA Technical Reports Server (NTRS)

    Coffey, E. E.; Geye, R. P.

    1970-01-01

    The Thorad-Agena is a two-stage launch vehicle consisting of a Thorad first-stage and an Agena second-stage, connected by a booster adapter. The composite vehicle, including the shroud and the booster adapter, is about 33 meters (109 ft) long. The total weight at lift-off is approximately 91 625 kilograms (202 000 lbm).

  16. Japan's launch vehicles

    NASA Astrophysics Data System (ADS)

    Kuroda, Y.; Hara, N.

    The development of Japan's Mu series scientific research launch vehicles, and N and H series practical applications vehicles, is described. The three-stage M-3C features a second-stage radio inertial guidance system. The evolution to the M-3S includes a first-stage TVC and Solid Motor Roll Control device, and eight 310-m strap-on boosters (SOB's). The M-3SII developed to launch an interplanetary satellite for the 1986 Halley's Comet apparition, employs two 735-mm SOB's and a microprocessor digitalized flight control system, and can put a 770 kg satellite into low earth orbit. The N-1 is a three-stage radio-guided vehicle using first and second stage liquid engines, a solid motor third stage, three SOB's, and having the capability to launch a 145 kg geostationary satellite. N-II improvements include a 350 kg geostationary payload capacity, nine SOB's, and an inertial guidance system. The H-1 planned for 1987 has a 550 kg geostationary payload capacity and a domestically developed cryogenic engine. The H-II planned for 1992 will be capable of launching a two-ton geostationary satellite, or LOX/LH2 plural satellites simultaneously. It will be powered by a single 95-ton thrust LE-7 main engine.

  17. AC 67 Launch Video

    NASA Technical Reports Server (NTRS)

    1987-01-01

    Live footage of the Unmanned Atlas Centaur (AC) 67 launch is presented on March 26, 1987 at the WESH television station in Florida. Lightning is shown after 49 seconds into the flight. The vehicle is totally destroyed due to a cloud-to-ground lightning flash.

  18. 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.

  19. Successful launch of SOHO

    NASA Astrophysics Data System (ADS)

    1995-12-01

    "Understanding how the Sun behaves is of crucial importance to all of us on Earth. It affects our everyday lives" said Roger Bonnet, Director of Science at ESA, who witnessed SOHO's spectacular nighttime launch from Cape Canaveral. "When SOHO begins work in four months time, scientists will, for the first time, be able to study this star 24 hours a day, 365 days a year". The 12 instruments on SOHO will probe the Sun inside out, from the star's very centre to the solar wind that blasts its way through the solar system. It will even listen to sounds, like musical notes, deep within the star by recording their vibrations when they reach the surface. SOHO was launched from Cape Canaveral Air Station, Florida, atop an Atlas IIAS rocket, at 09:08 CET on Saturday 2 December 1995. The 1.6 tonne observatory was released into its transfer orbit from the rocket's Centaur upper stage about two hours after launch. It will take four months for the satellite to reach its final position, a unique vantage point, located 1.5 million kilometres from Earth, where the gravitational pull of the Earth and Sun are equal. From here, the Lagrange point, SOHO will have an unobstructed view of the Sun all year round. SOHO's launch was delayed from 23 November because a flaw was discovered in a precision regulator, which throttles the power of the booster engine on the Atlas rocket. The system was replaced and retested before the launch. SOHO is a project of international cooperation between ESA and NASA. The spacecraft was designed and built in Europe, NASA provided the launch and will operate the satellite from its Goddard Space Flight Center, Maryland. European scientists provided eight of the observatory's instruments and US scientists a further three. The spacecraft is part of the international Solar-Terrestrial Science Programme, the next member of which is Cluster, a flotilla of four spacecraft that will study how the Sun affects Earth and surrounding space. Cluster is scheduled for

  20. A Clinically Integrated Post-Graduate Training Programme in Evidence-Based Medicine versus ‘No Intervention’ for Improving Disability Evaluations: A Cluster Randomised Clinical Trial

    PubMed Central

    Kok, Rob; Hoving, Jan L.; Smits, Paul B. A.; Ketelaar, Sarah M.; van Dijk, Frank J. H.; Verbeek, Jos H.

    2013-01-01

    Background Although several studies have shown that teaching EBM is effective in improving knowledge, at present, there is no convincing evidence that teaching EBM also changes professional behaviour in practice. Therefore, the primary aim of this study was to evaluate the effectiveness of a clinically integrated post-graduate training programme in EBM on evidence-based disability evaluation. Methods and Findings In a cluster randomised controlled trial, fifty-four case-based learning groups consisting of 132 physicians and 1680 patients were randomly assigned to the intervention or control groups. A clinically integrated, post-graduate, 5-day training programme in evidence-based medicine, consisting of (home) assignments, peer teaching, interactive training in searching databases, lectures and brainstorming sessions was provided to the intervention group. The control group received no training. The primary outcome was evidence-based disability evaluation, as indicated by the frequency in use of evidence of sufficient quality in disability evaluation reports. There are no general EBM behaviour outcome measures available. Therefore, we followed general guidelines for constructing performance indicators and defined an a priori cut-off for determination of sufficient quality as recommended for evaluating EB training. Physicians trained in EBM performed more evidence-based disability evaluations compared to physicians in the control group (difference in absolute proportion 9.7%, 95% CI 3.5 to 15.9). The primary outcome differences between groups remained significant after both cluster-adjusted analysis and additional sensitivity analyses accounting for subjects lost to follow-up. Conclusions A EBM programme successfully improved the use of evidence in a non-hospital based medical specialty. Our findings support the general recommendations to use multiple educational methods to change physician behaviour. In addition, it appeared important that the professional context

  1. The effect of selective serotonin reuptake inhibitors in healthy first-degree relatives of patients with major depressive disorder - an experimental medicine blinded controlled trial.

    PubMed

    Knorr, Ulla Benedichte

    2012-04-01

    The mechanisms of action for selective serotonin re-uptake in-hibitors (SSRI) in depressed patients remain widely unknown. The serotonergic neurotransmitter system and the hypothalamic-pituitary-adrenal (HPA) system may interact. Further, the serotonergic neurotransmitter system seems closely linked to personality and cognition. It is not known if SSRIs have a direct effect on the HPA system, personality or cognition that is independent of their effect on depression. Thus, healthy individuals with a genetic liability for depression represent a group of particular interest when investigating if intervention with SSRIs affects these potential biomarkers. SSRIs may affect these potential biomarkers in depressed patients, but it is unclear if the effect is directly on the biomarkers or is secondary to the effect of SSRIs on depressive symptoms. It has newer been tested whether an intervention with a SSRI has a beneficial effect on these potential biomarkers in healthy individuals with a genetic liability for depression. The aim of the thesis was by an experimental medicine blinded controlled trial, to investigate if long-term intervention with SSRI versus placebo decreases cortisol response in the dexamethasone corticotropin-releasing hormone (DEX-CRH) test in healthy first-degree relatives to patients with major depressive disorder (MDD). Further, to test the hypothesis that a SSRI may reduce neuroticism in healthy first-degree relatives of patients with MDD. Finally, to test whether SSRI enhance cognitive function in healthy first-degree relatives of patients with MDD. Eighty healthy first-degree relatives to patients with MDD were randomised to receive escitalopram 10 mg versus matching pla-cebo daily for four weeks in a blinded trial. The primary outcome measure was the intervention difference in the change of the total area under the curve (CorAUCtotal) for plasma cortisol in the DEX-CRH test at entry to after four weeks of intervention. The secondary outcomes

  2. Cassini launch contingency effort

    NASA Astrophysics Data System (ADS)

    Chang, Yale; O'Neil, John M.; McGrath, Brian E.; Heyler, Gene A.; Brenza, Pete T.

    2002-01-01

    On 15 October 1997 at 4:43 AM EDT, the Cassini spacecraft was successfully launched on a Titan IVB/Centaur on a mission to explore the Saturnian system. It carried three Radioisotope Thermoelectric Generators (RTGs) and 117 Light Weight Radioisotope Heater Units (LWRHUs). As part of the joint National Aeronautics and Space Administration (NASA)/U.S. Department of Energy (DoE) safety effort, a contingency plan was prepared to address the unlikely events of an accidental suborbital reentry or out-of-orbital reentry. The objective of the plan was to develop procedures to predict, within hours, the Earth impact footprints (EIFs) for the nuclear heat sources released during the atmospheric reentry. The footprint predictions would be used in subsequent notification and recovery efforts. As part of a multi-agency team, The Johns Hopkins University Applied Physics Laboratory (JHU/APL) had the responsibility to predict the EIFs of the heat sources after a reentry, given the heat sources' release conditions from the main spacecraft. (No ablation burn-through of the heat sources' aeroshells was expected, as a result of earlier testing.) JHU/APL's other role was to predict the time of reentry from a potential orbital decay. The tools used were a three degree-of-freedom trajectory code, a database of aerodynamic coefficients for the heat sources, secure links to obtain tracking data, and a high fidelity special perturbation orbit integrator code to predict time of spacecraft reentry from orbital decay. In the weeks and days prior to launch, all the codes and procedures were exercised. Notional EIFs were derived from hypothetical reentry conditions. EIFs predicted by JHU/APL were compared to those by JPL and US SPACECOM, and were found to be in good agreement. The reentry time from orbital decay for a booster rocket for the Russian Progress M-36 freighter, a cargo ship for the Mir space station, was predicted to within 5 minutes more than two hours before reentry. For the

  3. [Osteopathic medicine].

    PubMed

    Klein, P; Lepers, Y; Salem, W

    2011-09-01

    Osteopathy is originated in the 19th century in the United States. Andrew Taylor Still seek for an alternative medical system to the orthodox medicine largely empirical and advocating bloodletting, calomel, etc., all of which was resumed with terms like" heroic medicine". Osteopathy as other alternative medical practices (homeopathy, eclecticism, etc.) based on rational and metaphysical postulates as vitalism or the fact that man is a divinely ordained machine. Still's approach was essentially manual and based on manipulation of the joints. Today osteopaths challenge these dogmas and seek to agree their practice within scientific biomedical standards. Even if strong randomized clinical trials are lacking, several surveys report how osteopathy gained public notoriety. Several recent meta-analyses pinpoint the benefit of the spinal manipulative treatment and even if there is no evidence that such an approach is superior to other advocated therapies there is no evidence that these therapies are more effective than the first one. The major indications for such a treatment are cervical and low back pain, either chronic or acute. The quality of the relationship between the practitioner and patient together with the placebo effect are important components of a treatment effect. Osteopathic education is an important aspect and only higher education institutions, i.e. universities can achieve and maintain adequate standards. Materia medica and surgery represent the two major therapeutic mainstreams in medicine; osteopathy considered as manual medicine could be the third one. PMID:22034767

  4. A perfect launch

    NASA Technical Reports Server (NTRS)

    2000-01-01

    Billows of smoke and steam spread across Launch Pad 39A as Space Shuttle Discovery lifts off on mission STS-92 to the International Space Station. The perfect on-time liftoff occurred at 7:17 p.m. EDT, sending a crew of seven on the 100th launch in the history of the Shuttle program. Discovery carries a payload that includes the Integrated Truss Structure Z-1, first of 10 trusses that will form the backbone of the Space Station, and the third Pressurized Mating Adapter that will provide a Shuttle docking port for solar array installation on the sixth Station flight and Lab installation on the seventh Station flight. Discovery's landing is expected Oct. 22 at 2:10 p.m. EDT.

  5. 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.

  6. Space Probe Launch

    NASA Technical Reports Server (NTRS)

    1970-01-01

    Managed by Marshall Space Flight Center, the Space Tug was a reusable multipurpose space vehicle designed to transport payloads to different orbital inclinations. Utilizing mission-specific combinations of its three primary modules (crew, propulsion, and cargo) and a variety of supplementary kits, the Space Tug was capable of numerous space applications. This 1970 artist's concept depicts the Tug's propulsion module launching a space probe into lunar orbit.

  7. Expendable launch vehicle propulsion

    NASA Technical Reports Server (NTRS)

    Fuller, Paul N.

    1991-01-01

    The current status is reviewed of the U.S. Expendable Launch Vehicle (ELV) fleet, the international competition, and the propulsion technology of both domestic and foreign ELVs. The ELV propulsion technology areas where research, development, and demonstration are most needed are identified. These propulsion technology recommendations are based on the work performed by the Commercial Space Transportation Advisory Committee (COMSTAC), an industry panel established by the Dept. of Transportation.

  8. Space Logistics: Launch Capabilities

    NASA Technical Reports Server (NTRS)

    Furnas, Randall B.

    1989-01-01

    The current maximum launch capability for the United States are shown. The predicted Earth-to-orbit requirements for the United States are presented. Contrasting the two indicates the strong National need for a major increase in Earth-to-orbit lift capability. Approximate weights for planned payloads are shown. NASA is studying the following options to meet the need for a new heavy-lift capability by mid to late 1990's: (1) Shuttle-C for near term (include growth versions); and (2) the Advanced Lauching System (ALS) for the long term. The current baseline two-engine Shuttle-C has a 15 x 82 ft payload bay and an expected lift capability of 82,000 lb to Low Earth Orbit. Several options are being considered which have expanded diameter payload bays. A three-engine Shuttle-C with an expected lift of 145,000 lb to LEO is being evaluated as well. The Advanced Launch System (ALS) is a potential joint development between the Air Force and NASA. This program is focused toward long-term launch requirements, specifically beyond the year 2000. The basic approach is to develop a family of vehicles with the same high reliability as the Shuttle system, yet offering a much greater lift capability at a greatly reduced cost (per pound of payload). The ALS unmanned family of vehicles will provide a low end lift capability equivalent to Titan IV, and a high end lift capability greater than the Soviet Energia if requirements for such a high-end vehicle are defined.In conclusion, the planning of the next generation space telescope should not be constrained to the current launch vehicles. New vehicle designs will be driven by the needs of anticipated heavy users.

  9. Launch of Zoological Letters.

    PubMed

    Fukatsu, Takema; Kuratani, Shigeru

    2016-02-01

    A new open-access journal, Zoological Letters, was launched as a sister journal to Zoological Science, in January 2015. The new journal aims at publishing topical papers of high quality from a wide range of basic zoological research fields. This review highlights the notable reviews and research articles that have been published in the first year of Zoological Letters, providing an overview on the current achievements and future directions of the journal. PMID:26853862

  10. 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

  11. 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)

  12. Launch Services Program EMC Issues

    NASA Technical Reports Server (NTRS)

    trout, Dawn

    2004-01-01

    Presentation covers these issues: (1) Vehicles of the Launch Services Program, (2) RF Environment, (3) Common EMC Launch Vehicle Payload Integration Issues, (4) RF Sensitive Missions and (5) Lightning Monitoring,

  13. Heavy Lift Launch Vehicle Concept

    NASA Technical Reports Server (NTRS)

    2004-01-01

    During the Space Shuttle development phase, Marshall plarners concluded a Heavy Lift Launch Vehicle (HLLV) would be needed for successful Space Industrialization. Shown here in this 1976's artist's conception is an early version of the HLLV during launch.

  14. Launch Vehicle Control Center Architectures

    NASA Technical Reports Server (NTRS)

    Watson, Michael D.; Epps, Amy; Woodruff, Van; Vachon, Michael Jacob; Monreal, Julio; Williams, Randall; McLaughlin, Tom

    2014-01-01

    This analysis is a survey of control center architectures of the NASA Space Launch System (SLS), United Launch Alliance (ULA) Atlas V and Delta IV, and the European Space Agency (ESA) Ariane 5. Each of these control center architectures have similarities in basic structure, and differences in functional distribution of responsibilities for the phases of operations: (a) Launch vehicles in the international community vary greatly in configuration and process; (b) Each launch site has a unique processing flow based on the specific configurations; (c) Launch and flight operations are managed through a set of control centers associated with each launch site, however the flight operations may be a different control center than the launch center; and (d) The engineering support centers are primarily located at the design center with a small engineering support team at the launch site.

  15. SMAP Launch and Deployment Sequence

    NASA Video Gallery

    This video combines file footage of a Delta II rocket and computer animation to depict the launch and deployment of NASA's Soil Moisture Active Passive satellite. SMAP is scheduled to launch on Nov...

  16. 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.

  17. 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.

  18. Nuclear Medicine

    MedlinePlus

    ... Parents/Teachers Resource Links for Students Glossary Nuclear Medicine What is nuclear medicine? What are radioactive tracers? ... funded researchers advancing nuclear medicine? What is nuclear medicine? Nuclear medicine is a medical specialty that uses ...

  19. Space Shuttle Columbia launch

    NASA Technical Reports Server (NTRS)

    1995-01-01

    A Great Blue Heron seems oblivious to the tremendous spectacle of light and sound generated by a Shuttle liftoff, as the Space Shuttle Columbia (STS-73) soars skyward from Launch Pad 39B. Columbia's seven member crew's mission included continuing experimentation in the Marshall managed payloads including the United States Microgravity Laboratory 2 (USML-2) and the keel-mounted accelerometer that characterizes the very low frequency acceleration environment of the orbiter payload bay during space flight, known as the Orbital Acceleration Research Experiment (OARE).

  20. STS-39 Launch

    NASA Technical Reports Server (NTRS)

    1991-01-01

    Launched aboard the Space Shuttle Discovery on April 28, 1991 at 7:33:14 am (EDT), STS-39 was a Department of Defense (DOD) mission. The crew included seven astronauts: Michael L. Coats, commander; L. Blaine Hammond, pilot; Guion S. Buford, Jr., mission specialist 1; Gregory J. Harbaugh, mission specialist 2; Richard J. Hieb, mission specialist 3; Donald R. McMonagle, mission specialist 4; and Charles L. Veach, mission specialist 5. The primary unclassified payload included the Air Force Program 675 (AFP-675), the Infrared Background Signature Survey (IBSS), and the Shuttle Pallet Satellite II (SPAS II).

  1. Expendable launch vehicle studies

    NASA Technical Reports Server (NTRS)

    Bainum, Peter M.; Reiss, Robert

    1995-01-01

    Analytical support studies of expendable launch vehicles concentrate on the stability of the dynamics during launch especially during or near the region of maximum dynamic pressure. The in-plane dynamic equations of a generic launch vehicle with multiple flexible bending and fuel sloshing modes are developed and linearized. The information from LeRC about the grids, masses, and modes is incorporated into the model. The eigenvalues of the plant are analyzed for several modeling factors: utilizing diagonal mass matrix, uniform beam assumption, inclusion of aerodynamics, and the interaction between the aerodynamics and the flexible bending motion. Preliminary PID, LQR, and LQG control designs with sensor and actuator dynamics for this system and simulations are also conducted. The initial analysis for comparison of PD (proportional-derivative) and full state feedback LQR Linear quadratic regulator) shows that the split weighted LQR controller has better performance than that of the PD. In order to meet both the performance and robustness requirements, the H(sub infinity) robust controller for the expendable launch vehicle is developed. The simulation indicates that both the performance and robustness of the H(sub infinity) controller are better than that for the PID and LQG controllers. The modelling and analysis support studies team has continued development of methodology, using eigensensitivity analysis, to solve three classes of discrete eigenvalue equations. In the first class, the matrix elements are non-linear functions of the eigenvector. All non-linear periodic motion can be cast in this form. Here the eigenvector is comprised of the coefficients of complete basis functions spanning the response space and the eigenvalue is the frequency. The second class of eigenvalue problems studied is the quadratic eigenvalue problem. Solutions for linear viscously damped structures or viscoelastic structures can be reduced to this form. Particular attention is paid to

  2. STS-86 Atlantis Launch

    NASA Technical Reports Server (NTRS)

    1997-01-01

    The Space Shuttle Atlantis blazes through the night sky to begin the STS-86 mission, slated to be the seventh of nine planned dockings of the Space Shuttle with the Russian Space Station Mir. Liftoff on Sept. 25 from Launch Pad 39A was at 10:34:19 p.m. EDT, within seconds of the preferred time, during a six-minute, 45- second launch window. The 10-day flight will include the transfer of the sixth U.S. astronaut to live and work aboard the Mir. After the docking, STS-86 Mission Specialist David A. Wolf will become a member of the Mir 24 crew, replacing astronaut C. Michael Foale, who will return to Earth aboard Atlantis with the remainder of the STS-86 crew. Foale has been on the Russian Space Station since mid-May. Wolf is scheduled to remain there about four months. Besides Wolf (embarking to Mir) and Foale (returning), the STS-86 crew includes Commander James D. Wetherbee, Pilot Michael J. Bloomfield, and Mission Specialists Wendy B. Lawrence, Scott E. Parazynski, Vladimir Georgievich Titov of the Russian Space Agency, and Jean-Loup J.M. Chretien of the French Space Agency, CNES. Other primary objectives of the mission are a spacewalk by Parazynski and Titov, and the exchange of about three-and-a-half tons of science/logistical equipment and supplies between Atlantis and the Mir.

  3. STS-86 Launch

    NASA Technical Reports Server (NTRS)

    1997-01-01

    The Space Shuttle Atlantis blazes through the night sky to begin the STS-86 mission, slated to be the seventh of nine planned dockings of the Space Shuttle with the Russian Space Station Mir. Liftoff on September 25 from Launch Pad 39A was at 10:34 p.m. EDT, within seconds of the preferred time, during a six minute, 45 second launch window. The 10 day flight will include the transfer of the sixth U.S. astronaut to live and work aboard the Mir. After the docking, STS-86 Mission Specialist David A. Wolf will become a member of the Mir 24 crew, replacing astronaut C. Michael Foale, who will return to Earth aboard Atlantis with the remainder of the STS-86 crew. Foale has been on the Russian Space Station since mid May. Wolf is scheduled to remain there about four months. Besides Wolf (embarking to Mir) and Foale (returning), the STS-86 crew includes Commander James D. Wetherbee, Pilot Michael J. Bloomfield, and Mission Specialists Wendy B. Lawrence, Scott E. Parazynski, Vladimir Georgievich Titov of the Russian Space Agency, and Jean-Loup J.M. Chretien of the French Space Agency, CNES. Other primary objectives of the mission are a spacewalk by Parazynski and Titov, and the exchange of about 3.5 tons of science/logistical equipment and supplies between Atlantis and the Mir.

  4. Magnetic Launch Assist

    NASA Technical Reports Server (NTRS)

    Jacobs, W. A.

    2000-01-01

    With the ever-increasing cost of getting to space and the need for safe, reliable, and inexpensive ways to access space, NASA is taking a look at technologies that will get us there. One of these technologies is Magnetic Launch Assist (MagLev). This is the concept of using both magnetic levitation and magnetic propulsion to provide an initial velocity by using electrical power from ground sources. The use of ground based power can significantly reduce operational costs over the consumables necessary to attain the same velocity. The technologies to accomplish this are both old and new. The concept of MagLev has been around for a long time and several MagLev Trains have already been made. Where NASA's MagLev diverges from the traditional train is in the immense power required to propel this vehicle to 600 feet per second in less than 10 seconds. New technologies or the upgrade of existing technologies will need to be investigated in areas of energy storage and power switching. Plus the separation of a very large mass (the space vehicle) and the aerodynamics of that vehicle while on the carrier are also of great concern and require considerable study and testing. NASA's plan is to mature these technologies in the next 10 years to achieve our goal of launching a full sized space vehicle off a MagLev rail.

  5. Mortar launched surveillance system

    NASA Astrophysics Data System (ADS)

    Lewis, Carl E.; Carlton, Lindley A.

    2001-02-01

    Accurate Automation Corporation has completed the conceptual design of a mortar launched air vehicle system to perform close range or over-the-horizon surveillance missions. Law enforcement and military units require an organic capability to obtain real time intelligence information of time critical targets. Our design will permit law enforcement to detect, classify, locate and track these time critical targets. The surveillance system is a simple, unmanned fixed-winged aircraft deployed via a conventional mortar tube. The aircraft's flight surfaces are deployed following mortar launch to permit maximum range and time over target. The aircraft and sensor system are field retrievable. The aircraft can be configured with an engine to permit extended time over target or range. The aircraft has an integrated surveillance sensor system; a programmable CMOS sensor array. The integrated RF transmitted to capable of down- linking real-time video over line-of-sight distances exceeding 10 kilometers. The major benefit of the modular design is the ability to provide surveillance or tracking quickly at a low cost. Vehicle operational radius and sensor field coverage as well as design trade results of vehicle range and endurance performance and payload capacity at operational range are presented for various mortar configurations.

  6. 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.

  7. Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care

    PubMed Central

    2014-01-01

    Background Physical activity (PA) and nutrition are the cornerstones of diabetes management. Several reviews and meta-analyses report that PA independently produces clinically important improvements in glucose control in people with Type 2 diabetes. However, it remains unclear what the optimal strategies are to increase PA behaviour in people with Type 2 diabetes in routine primary care. Methods This study will determine whether an evidence-informed multifaceted behaviour change intervention (Movement as Medicine for Type 2 Diabetes) targeting both consultation behaviour of primary healthcare professionals and PA behaviour in adults with Type 2 diabetes is both acceptable and feasible in the primary care setting. An open pilot study conducted in two primary care practices (phase one) will assess acceptability, feasibility and fidelity. Ongoing feedback from participating primary healthcare professionals and patients will provide opportunities for systematic adaptation and refinement of the intervention and study procedures. A two-arm parallel group clustered pilot randomised controlled trial with patients from participating primary care practices in North East England will assess acceptability, feasibility, and fidelity of the intervention (versus usual clinical care) and trial processes over a 12-month period. Consultation behaviour involving fidelity of intervention delivery, diabetes and PA related knowledge, attitudes/beliefs, intentions and self-efficacy for delivering a behaviour change intervention targeting PA behaviour will be assessed in primary healthcare professionals. We will rehearse the collection of outcome data (with the focus on data yield and quality) for a future definitive trial, through outcome assessment at baseline, one, six and twelve months. An embedded qualitative process evaluation and treatment fidelity assessment will explore issues around intervention implementation and assess whether intervention components can be reliably and

  8. Medicinal plants: conception / contraception.

    PubMed

    Chaing, H S; Merino-chavez, G; Yang, L L; Wang, F N; Hafez, E S

    1994-01-01

    Researchers have conducted considerable experiments on the effectiveness and therapeutic values of Chinese herbs and parts of plants. We should not ignore the significance of natural medicine. The Chinese have been perfecting medicinal therapy based on the raw ingredients of plants/herbs and their derivatives for thousands of years. Chinese practitioners of traditional medicine prescribe medicines based on yin and yang. Traditional medicine is communicated in a verb or written form. Natural resources used in traditional medicine to treat diseases are not limited to just medicinal plants but also include animals, shell fish, and minerals. Parts of plants used in traditional medicine are leaves, stems, flowers, bark, and root. Chinese medicine is the world's oldest continuous surviving tradition. The Chinese experimented with local plants, often resulting in mild to violent reactions. This process allowed them to become familiar with poisonous plants and those that could relieve pain or successfully treat illness. Current allopathic medicines are composed of synthetic compounds copied from natural chemical derivatives, which tend to be more potent than the original compound. Some medicinal plants used to effect conception/contraception include Striga astiatica (contraceptive); Eurycoma longifolia (male virility); and a mixture of lengkuas, mengkudu masak, black pepper seeds, ginger, salt, and 2 eggs (increase libido). Women in Malaysia take jamu to preserve their body shape and to provide nutrition during pregnancy. Praneem causes local cell-mediated immunity in the uterus. Clinical trials of Praneem with or without the hCG vaccine are planned. PMID:12287843

  9. 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.

  10. Herbal medicines for viral myocarditis

    PubMed Central

    Liu, Zhao Lan; Liu, Zhi Jun; Liu, Jian Ping; Yang, Min; Kwong, Joey

    2012-01-01

    Background Herbal medicines are being used for treating viral diseases including viral myocarditis, and many controlled trials have been done to investigate their efficacy. Objectives To assess the effects of herbal medicines on clinical and indirect outcomes in patients with viral myocarditis. Search strategy We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library Issue 3, 2009, MEDLINE (January 1966 - July 2009), EMBASE (January 1998 - July 2009), Chinese Biomedical Database (1979 - 2009), China National Knowledge Infrastructure (1979 - 2009), Chinese VIP Information (1989 - 2009), Chinese Academic Conference Papers Database and Chinese Dissertation Database (1980 - 2009), AMED (1985 - 2009), LILACS accessed in July 2009 and the trials register of the Cochrane Complementary Medicine Field. We handsearched Chinese journals and conference proceedings. No language restrictions were applied. Selection criteria Randomised controlled trials of herbal medicines (with a minimum of seven days treatment duration) compared with placebo, no intervention, or conventional interventions were included. Trials of herbal medicine plus conventional drug versus drug alone were also included. Only trials that reported adequate description of allocation sequence generation were included. Data collection and analysis Two review authors independently extracted data and evaluated trial quality. Adverse effects information was collected from the trials. Main results Fourteen randomised trials involving 1463 people were included. All trials were conducted and published in China. Quality of the trials was assessed to be low. No trial had diagnosis of viral myocarditis confirmed histologically, and only a few trials attempted to establish viral aetiology. Nine different herbal medicines were tested in the included trials. The trials reported electrocardiogram results, level of myocardial enzymes, cardiac function, symptoms, and adverse effects

  11. Herbal medicines for viral myocarditis

    PubMed Central

    Liu, Zhao Lan; Liu, Zhi Jun; Liu, Jian Ping; Yang, Min; Kwong, Joey

    2011-01-01

    Background Herbal medicines are being used for treating viral diseases including viral myocarditis, and many controlled trials have been done to investigate their efficacy. Objectives To assess the effects of herbal medicines on clinical and indirect outcomes in patients with viral myocarditis. Search methods We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library Issue 3, 2009, MEDLINE (January 1966 - July 2009), EMBASE (January 1998 - July 2009), Chinese Biomedical Database (1979 - 2009), China National Knowledge Infrastructure (1979 - 2009), Chinese VIP Information (1989 - 2009), Chinese Academic Conference Papers Database and Chinese Dissertation Database (1980 - 2009), AMED (1985 - 2009), LILACS accessed in July 2009 and the trials register of the Cochrane Complementary Medicine Field. We handsearched Chinese journals and conference proceedings. No language restrictions were applied. Selection criteria Randomised controlled trials of herbal medicines (with a minimum of seven days treatment duration) compared with placebo, no intervention, or conventional interventions were included. Trials of herbal medicine plus conventional drug versus drug alone were also included. Only trials that reported adequate description of allocation sequence generation were included. Data collection and analysis Two review authors independently extracted data and evaluated trial quality. Adverse effects information was collected from the trials. Results Fourteen randomised trials involving 1463 people were included. All trials were conducted and published in China. Quality of the trials was assessed to be low. No trial had diagnosis of viral myocarditis confirmed histologically, and only a few trials attempted to establish viral aetiology. Nine different herbal medicines were tested in the included trials. The trials reported electrocardiogram results, level of myocardial enzymes, cardiac function, symptoms, and adverse effects. Astragalus

  12. 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.

  13. STS-112 Launch

    NASA Technical Reports Server (NTRS)

    2002-01-01

    Space Shuttle Orbiter Atlantis hurdles toward space from Launch Pad 39B at Kennedy Space Center in Florida for the STS-112 mission. Liftoff occurred at 3:46pm EDT, October 7, 2002. Atlantis carried the Starboard-1 (S1) Integrated Truss Structure and the Crew and Equipment Translation Aid (CETA) Cart A. The S1 was the second truss structure installed on the International Space Station (ISS). It was attached to the S0 truss which was previously installed by the STS-110 mission. The CETA is the first of two human-powered carts that ride along the ISS railway, providing mobile work platforms for future space walking astronauts. The 11 day mission performed three space walks to attach the S1 truss.

  14. STS-92 Discovery Launch

    NASA Technical Reports Server (NTRS)

    2000-01-01

    Viewed from across the waters of Banana Creek, clouds of smoke and steam are illuminated by the flames from Space Shuttle Discovery'''s perfect on-time launch at 7:17 p.m. EDT. Discovery carries a crew of seven on a construction flight to the International Space Station. Discovery also carries a payload that includes the Integrated Truss Structure Z-1, first of 10 trusses that will form the backbone of the Space Station, and the third Pressurized Mating Adapter that will provide a Shuttle docking port for solar array installation on the sixth Station flight and Lab installation on the seventh Station flight. Discovery'''s landing is expected Oct. 22 at 2:10 p.m. EDT.

  15. Payload Launch Lock Mechanism

    NASA Technical Reports Server (NTRS)

    Young, Ken (Inventor); Hindle, Timothy (Inventor)

    2014-01-01

    A payload launch lock mechanism includes a base, a preload clamp, a fastener, and a shape memory alloy (SMA) actuator. The preload clamp is configured to releasibly restrain a payload. The fastener extends, along an axis, through the preload clamp and into the base, and supplies a force to the preload clamp sufficient to restrain the payload. The SMA actuator is disposed between the base and the clamp. The SMA actuator is adapted to receive electrical current and is configured, upon receipt of the electrical current, to supply a force that causes the fastener to elongate without fracturing. The preload clamp, in response to the fastener elongation, either rotates or pivots to thereby release the payload.

  16. LAUNCH_BLTMS.DLL

    Energy Science and Technology Software Center (ESTSC)

    2005-12-14

    Postprocessor for the integration of the BLT-MS (Breach Leach Transport-Multi Species) code with GoldSim{trademark}. The program is intended as a DLL for use with a GoldSim{trademark}. The program is intended as a DLL for use with a GoldSim{trademark} model file. The code executes BTLMS.EXE using a standard BLT-MS input file and allocated parameters to memory for subsequent input of BLTMS.EXE output dat to a GoldSim{trademark} model file. This DLL is used for performing Monte Carlomore » analyses. The software is used as part of a modeling package that consists of BLTMS.EXE, GoldSim{trademark}, Read_BLT.DLL and Launch_BLTMS.DLL. The modeling package is used to run Monte Crlo analyses for performance assessment of Low level Radioactive Waste Repositories.« less

  17. STS-118 Launch

    NASA Technical Reports Server (NTRS)

    2007-01-01

    Enroute to the International Space Station (ISS), Space Shuttle Endeavor and its seven member STS-118 crew, blasted off from the launch pad at Kennedy Space Center on August 8, 2007. Construction resumed on the ISS as STS-118 mission specialists and the Expedition 15 crew completed installation of the third Starboard 5 (S-5) truss segment, removed a faulty Control Moment Gyroscope (CMG-3), installed a new CMG into the Z1 truss, relocated the S-band Antenna Sub-Assembly from the Port 6 (P6) to Port 1 (P1) truss, installed a new transponder on P1, retrieved the P6 transponder, and delivered roughly 5,000 pounds of equipment and supplies.

  18. STS-87 Columbia Launch

    NASA Technical Reports Server (NTRS)

    1997-01-01

    Like a rising sun lighting up the afternoon sky, the Space Shuttle Columbia soars from Launch Pad 39B at 2:46:00 p.m. EST, November 19, on the fourth flight of the United States Microgravity Payload and Spartan-201 satellite. The crew members include Mission Commander Kevin Kregel.; Pilot Steven Lindsey; Mission Specialists Kalpana Chawla, Ph.D., Winston Scott, and Takao Doi, Ph.D., of the National Space Development Agency of Japan; and Payload Specialist Leonid Kadenyuk of the National Space Agency of Ukraine. During the 16-day STS-87 mission, the crew will oversee experiments in microgravity; deploy and retrieve a solar satellite; and test a new experimental camera, the AERCam Sprint. Dr. Doi and Scott also will perform a spacewalk to practice International Space Station maneuvers.

  19. 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.

  20. Effect of regulation reform on clinical trials for registering novel therapeutic agents in Taiwan: a chronological analysis.

    PubMed

    Sun, I-Chen; Shy, Horng-Shing; Liao, Tzu-Ya

    2016-06-01

    The registration process for new drugs is crucial in the clinical application of medicines. Previously, the registration of imported novel therapeutic agents in Taiwan depended considerably on their approvals in developed countries. The Taiwanese government enacted Article 38-1 of the Regulations for Registration of Medicinal Products in September 2009. According to the new submission criteria, approvals may be exempted if the number of Taiwanese participants in the clinical trials fulfills the required threshold. The present study compared the profiles of clinical trials of novel therapeutic agents before and after the enactment of this regulation in terms of over-threshold trials, structural types, and therapeutic areas across phases. The outcome-whether the liberalization of the submission criteria functioned as an incentive to launch clinical trials in Taiwan-was also evaluated. The results revealed that the number of clinical trial applications increased after the reformed regulation was enacted, even after the over-threshold criteria were considered; however, the increase disappeared for phase III trials. Most clinical trials were for chemical products and antineoplastic agents across all phases and study periods before and after the enactment of Article 38-1. Furthermore, the increase in the number of international clinical trials conducted in Taiwan was not directly caused by the regulation reform because the percentage of investigational products fulfilling the exemption criteria did not increase. These paradoxical results were interpreted in several aspects, referring particularly to the well-established infrastructure for launching clinical trials as well as the integral environment of medical services in Taiwan. PMID:26780084

  1. 14 CFR 417.125 - Launch of an unguided suborbital launch vehicle.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Launch of an unguided suborbital launch vehicle. (a) Applicability. This section applies only to a launch operator conducting a launch of an unguided suborbital launch vehicle. (b) Need for flight safety system. A launch operator must launch an unguided suborbital launch vehicle with a flight safety system...

  2. 14 CFR 417.125 - Launch of an unguided suborbital launch vehicle.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Launch of an unguided suborbital launch vehicle. (a) Applicability. This section applies only to a launch operator conducting a launch of an unguided suborbital launch vehicle. (b) Need for flight safety system. A launch operator must launch an unguided suborbital launch vehicle with a flight safety system...

  3. 14 CFR 417.125 - Launch of an unguided suborbital launch vehicle.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Launch of an unguided suborbital launch vehicle. (a) Applicability. This section applies only to a launch operator conducting a launch of an unguided suborbital launch vehicle. (b) Need for flight safety system. A launch operator must launch an unguided suborbital launch vehicle with a flight safety system...

  4. Qualification opinion of novel methodologies in the predementia stage of Alzheimer's disease: cerebro-spinal-fluid related biomarkers for drugs affecting amyloid burden--regulatory considerations by European Medicines Agency focusing in improving benefit/risk in regulatory trials.

    PubMed

    Isaac, Maria; Vamvakas, Spiros; Abadie, Eric; Jonsson, Bertil; Gispen, Christine; Pani, Luca

    2011-11-01

    The European Medicines Agency (EMA) in London is responsible for the Regulatory review of new medicinal products for Marketing Authorisation, through which pharmaceutical companies may obtain first Marketing Authorisation and subsequent Variations valid throughout the EU and EFTA. The qualification opinion of novel methodologies is a new procedure where applicants can obtain scientific advice on new methodologies for regulatory clinical trials of efficacy of new compounds. It will help benefit/risk assessment of the CHMP. The definition of prodromal AD is acceptable. The "Dubois Criteria" as criteria to define the population must be validated in full at the time of the submission of the dossiers. Including a positive CSF biomarker profile is considered predictive for the evaluation of the AD-dementia type. However, although high CSF tau and low CSF Aβ42 are predictive of Alzheimer's disease, the criterion "positive CSF tau/Aβ42 ratio" is not well defined. The qualification of biomarkers in the pre-dementia stage of Alzheimer's disease will allow better inclusion criteria of patients in pre-dementia trials in which the benefit/risk is higher for treatment with these novel compounds. PMID:21903360

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Advanced therapy medicinal products: current and future perspectives

    PubMed Central

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

    2016-01-01

    Background Advanced therapy medicinal products (ATMPs) are innovative therapies that encompass gene therapy, somatic cell therapy, and tissue-engineered products. These therapies are expected to bring important health benefits, but also to substantially impact the pharmaceuticals budget. Objective The aim of this study was to characterise the ATMPs in development and discuss future implications in terms of market access. Methods Clinical trials were searched in the following databases: EudraCT (EU Drug Regulating Authorities Clinical Trials), ClinicalTrials.gov, and ICTRP (International Clinical Trials Registry Platform of the World Health Organization). Trials were classified by category of ATMP as defined by European regulation EC No. 1394/2007, as well as by development phase and disease area. Results The database search identified 939 clinical trials investigating ATMPs (85% ongoing, 15% completed). The majority of trials were in the early stages (Phase I, I/II: 64.3%, Phase II, II/III: 27.9%, Phase 3: 6.9%). Per category of ATMP, we identified 53.6% of trials for somatic cell therapies, 22.8% for tissue-engineered products, 22.4% for gene therapies, and 1.2% for combined products (incorporating a medical device). Disease areas included cancer (24.8%), cardiovascular diseases (19.4%), musculoskeletal (10.5%), immune system and inflammation (11.5%), neurology (9.1%), and others. Of the trials, 47.2% enrolled fewer than 25 patients. Due to the complexity and specificity of ATMPs, new clinical trial methodologies are being considered (e.g., small sample size, non-randomised trials, single-arm trials, surrogate endpoints, integrated protocols, and adaptive designs). Evidence generation post-launch will become unavoidable to address payers’ expectations. Conclusion ATMPs represent a fast-growing field of interest. Although most of the products are in an early development phase, the combined trial phase and the potential to cure severe chronic conditions suggest

  10. 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.