Europe needs to carry out more independent academic clinical research to establish the optimal standard of care, speed up access to treatments, ensure the most efficient use of limited health budgets and maintain leadership and competitiveness.
However, the field is tremendously complex and the level of bureaucracy involved creates a considerable workload, deterring clinicians from becoming involved in international independent clinical trials, what is known now as Investigator Driven Clinical Trials (IDCT).
It is acknowledged that much of this bureaucratic burden is generated by the implementation of the European Clinical Trials Directive 2001/20/EC. Moves are now in hand to reform the Directive, and the conference was organised with the support of the current Belgian Presidency of the European Union to pull together all stakeholders to share views on the shape of this reform and to discuss wider issues around EU funding of IDCT. It is hoped these discussions will contribute to recommendations for streamlining, simplifying and harmonising the conduct of international investigator driven clinical trials.
There is concern that the way in which the Directive has been enshrined in national law is hampering academic clinical trials in some countries.
This is why the focus of the conference was international academic trials only and concentrated on how the Directive could be reshaped to foster more cross-border research.
In his Welcome and Introduction Benoit Cerexhe, Brussels Minister for the Economy and Employment and President of the Research Section of the Competitiveness Council of the EU, welcomed the 200 participants from 18 countries, and underlined the commitment which the Belgian Presidency has made to improving international cooperation in research.
Given this, it is unfortunate that too few patients are aware of the benefits of clinical trials, and that doctors are deterred because of a lack of time and the complexities of accessing funding, said Cerexhe.
However, in Framework Programme 7, "Budgets are going in the right direction," and there is particular emphasis on clinical trials. "We all have to go further, and I hope the message of this conference is heard," Cerexhe told delegates.
The European Commission agrees that the complexity around Framework Programme 7 grants, "Has reached a level of complexity that is frustrating [FP7's] objectives," Cerexhe said, adding that the Belgian Presidency is committed to simplifying this area.
Another priority of the Presidency is the future research and innovation plan, Euro2020, which is due to be published at the end of September. This will include measures for funding technology transfer, removing obstacles to innovation – for example by pushing forward with the creation of the single EU patent – and addressing the shortage of researchers and qualified scientific and technical support staff.
At the same time the Belgian Presidency will promote the development of the single European Research Area, building on the recently established pan-European project on Alzheimer's Disease, to encourage more joint programming by national research councils, seek greater convergence of national research policies, and open up EU research programmes to the rest of the world.
Ruxandra Draghia-Akli, Director of the Health Directorate at DG Research emphasised the extent to which European Commission funding for clinical research has been reinforced in recent years in her talk, "Clinical Research in Europe: the DG Research Perspective." Of the money devoted to health research in Framework Programme 7, the largest portion is dedicated to translational research in major disease areas, and the 2011 call, published on 19th July 2010, has a major focus on investigator driven clinical trials.
Draghia-Akli made a commitment that this focus will be maintained in the remaining calls under FP7 which runs until 2013. At the same time, she noted that clarification on how this funding is disbursed was provided in a recent memorandum. In parallel, the Health Directorate has funded the development of the infrastructure to support the conduct of multi-centre clinical trials in ECRIN – the European Clinical Research Infrastructure Network. ECRIN can provide support for investigators applying for FP7 funding and can act as partner or subcontractor.
The European Commission has funded work to increase patient involvement, including children and the elderly, in clinical trials. "We hope patients and patients' organisations will be involved in a much more consistent and intelligent way," said Draghia-Akli.
The Health Directorate also funded ICREL (Impact on Clinical Research of European Legislation), a one year investigation into the impact of EU legislation on clinical research. This has provided important input into the discussion taking place currently on reforms to the European Clinical Trials Directive.
In addition, nine clinical projects have been funded to date under FP7, including NEMO, which is investigating the use of bumetanide in treating neonatal seizures, and Loullaphilla, which is developing 6-mercaptopurine and methotrexate oral formulations for maintenance treatment of acute lymphoblastic leukaemia in children.
"In other words, we are not working in a vacuum. There's a long history of funding in this type of investigator driven clinical trial' said Draghia-Akli.
Medical research is the source of new knowledge that will both improve treatments and constrain costs. At the same time this will have the important economic impact of promoting the development of Europe's medical industry. Research carried out by the UK medical research charity the Wellcome Trust shows investment in medical research gives a return of 39 per cent for each of the following years.
At the same time, science is global and Europe can draw on research from the rest of the world in seeking to address the Grand Challenges. The US remains pre-eminent in medical research, and on top of spending three times as much on research as Europe, the US also has the advantage of a single regulatory framework for research.
As an example of how this is leveraged to promote innovation, Højgaard noted that Margaret Hamburg of the FDA and Francis Collins of the NIH have agreed to team up in the development of personalised medicine. Europe too needs to combine its resources in this important field, and in particular shared biobanks and databases are needed to drive personalised medicine forward.
In addition, the European Research Areas needs to be developed, and there must be mobility for researchers.
Ensure investigator driven trials are appropriately designed.
Højgaard also called for more joint programming noting that this happens in other scientific fields. "There is collaboration in nuclear physics, so why not in medical research?" she said. In this respect the Innovative Medicines Initiative is an important exemplar. "I do hope this area of pre-competitive research really does develop into something," Højgaard, concluded. Harold zur Hausen, of Deutsches Krebforschungszentrum and winner of the Nobel Prize for Physiology and Medicine in 2008, took his 48 year career as a researcher working to elucidate the role of infections in cancer as a case study to demonstrate that improving cancer treatments relies on many different strands of research, from basic research into the mechanics of cancer development, to applied research to devise the best therapeutic regimes.
In his presentation, "Perspectives for Basic and Applied Cancer Research in Europe", zur Hausen said he "feels very strongly" that the past separation of the chemical, physical and biological factors that cause cancer is becoming more and more outdated. "Biological carcinogens – that is specific infections – regularly interact with physical and chemical carcinogens," zur Hausen said.
Fifty years ago the role of infection in cancer was unknown. Now, it is understood that more than 20 per cent of cancers are linked to infections – making infection the most important risk factor, exceeding even smoking tobacco. "It's clear that research on the infectious causes of cancer has permitted a better understanding of events leading to carcinogenesis," zur Hausen said.
This fundamental insight has made it possible to prevent cancer by dealing with the infection that trigger it. Examples include the use of antibiotics to prevent stomach cancers promoted by Helicobacter pylori, and vaccination to prevent cervical cancer caused by human papillomavirus.
Of the 21 per cent of cancers caused by infections, 71per cent are now preventable by treating the infection. These types of prevention do not require a change in lifestyle and have a very low risk of side effects, zur Hausen noted.
This success, coupled with emerging evidence pointing to a role for infections in a number of other cancers, highlights the need for increased research in cancer prevention.
It also underlines the importance or studying cancer epidemiology to find clues to the factors involved in specific human cancers. Colorectal cancer is an example of how good epidemiological studies can help in identifying mechanisms that initiate the disease process. A number of studies have proposed that eating red meat can cause colorectal cancer. It is suggested that this is due to chemical carcinogens produced when red meat is cooked. However, frying or grilling white meat such as chicken or fish, promotes the production of similar heterocyclic aromatic hydrocarbons.
In addition, the higher risk attributed to red meat appears to be mainly restricted to beef. So for example, the risk is low in China despite a high proportion of pork in the diet, and in Arab countries where a high level of lamb and mutton is eaten.
Prof. zur Hausen suggested the differences in carcinogenic risks could be explained by thermo-resistant infections, for example by a polyomavirus that is present exclusively in beef. He noted that a large number of infectious agents are likely able to survive the low temperatures at which rare beef is cooked.
"This demonstrates that curiosity-driven basic research, basic application-orientated research, and applied cancer research are all closely interlinked, and underlines the importance of knowing causation to improve prevention," zur Hausen said in conclusion.
There is often a perception that regulators are more sceptical about academic clinical research than they are about industry-sponsored research. "This is absolutely not the case: rather they distinguish between well-conducted, well designed trials and ones that are not," said Francesco Pignatti, Head of Oncology, Haematology and Diagnostics in the Unit for Human Medicines Development and Evaluation at the European Medicines Agency (EMA), in his discussion of the EMA's view of the role of academic trials, "Acceptance of Academic Trials in Europe: New treatments Approval".
Academic trials are judged by the same criteria as company trials, Pignatti said. They must meet the same standards in terms of establishing safety and efficiency and being in agreement with good clinical practice.
Pignatti himself has come across examples of both good and bad academic trials. In one example of a single arm academic trial in an orphan indication, the efficacy and safety objectives were met and the study was published in a peer reviewed journal. However, the Good Clinical Practice inspection showed the sample size had been increased without the protocol being amended; 60 per cent of the patients were not eligible, 30 per cent of patients had received other anticancer therapy. These and other irregularities led to the Marketing Authorisation being refused.
Health Technology Assessments and getting reimbursement are post-approval hurdles, and, Pignatti said, in future the paradigm could be to integrate these processes into drug approvals. "This would not be possible without academic trials," he concluded.
The reform of the European Clinical Trials Directive represents an important opportunity to enable patients to become fully engaged and properly represented in the trials process, said Kathy Oliver, Co-Director of the International Brain Tumour Alliance in her discussion on, "Patient Perspectives on clinical trials: recruitment, rights and ethical issues".
For a start, few lay people have any understanding of clinical trials and the potential benefits of taking part in them. Instead, they are concerned about being guinea pigs, about not getting treatment if they are in the placebo arm, and that consent forms protect the interests of researchers and drug companies, but not of patients.
These misconceptions, combined with a shortage of reliable, digestible, information, leaves people confused about whether or not it is a good thing to enrol in a clinical trial. In consequence, there is a low level of engagement. In cancer, for example, less than 5 per cent of patients take part in trials in the US, 5 – 6 per cent in mainland Europe and 11 per cent in the UK. "There are certainly problems with clinical trial recruitment from a patient perspective," Oliver said. And yet, she noted, innovation can be driven by patients.
The Brain Tumour Alliance often hears from patients who have not been offered the chance to be in a clinical trial. While there may be many reasons for this, there should be full disclosure and information about trials that are open. Online trial information and trial matching services are starting to be established.
Oliver suggested that the possibility of taking part in trials should be discussed early in the treatment process, and patients, families and caregivers should be helped to understand the benefits of clinical trials.
For this to happen, doctors need more training about clinical trials. There is also a need for properly-trained patient advocates. Other issues to be addressed to enable patients to become equal and engaged partners in clinical trials include insurance coverage, providing assistance if patients have to travel to take part in a trial, ethnic, cultural and language barriers that may prevent patients from enrolling in a trial, the fact that teenagers and those over 65 years of age are seldom offered the chance to be in trials, and the right to access healthcare in different EU countries.
Rather than thinking of them purely as "subjects", patients should be viewed as allies in the research process, by, for example, involving them in clinical trial design. "Patient preferences may be crucial to a trial's success – reducing dropout or boosting recruitment," Oliver noted.
There is also a need for greater patient involvement in ethics committees, Oliver said, pointing out that patient groups have been involved in the consultation on reform of the European Clinical Trials Directive. "Use our experience as patients and caregivers to create a clinical trials environment free of mystique; building patient involvement will improve European Clinical Trials," Oliver concluded.
The task of consulting on and drawing up reform of the European Clinical Trials Directive is the responsibility of DG Health and Consumers. Stefan Führing of the Pharmaceuticals Unit gave an assessment of the current situation and an update on progress in analysing responses to the public consultation and drafting revisions in "Revision of the Clinical Trials Directive 2001/20/EC – Improving the framework for clinical excellence in Europe".
Painting the backdrop to the review, Führing noted that the number of applications to run clinical trials in Europe fell by 10 per cent between 2007 – 2009. Not only that, the number of participants in proposed trials fell too, from 535,481 to 358,429. "As a policy maker and regulator, these figures are highly dissatisfactory," Fuhring said.
Of the 4,491 trials running in 2009, only 21 per cent involved sites in more than one European country. However, the 933 multinational trials that were running involved 249,944, or 70 per cent of all clinical trial participants.
Alongside work to draft a new Directive, the Commission's response has been to try and make the existing 2001 Directive work better. This has involved moves to strengthen cooperation between Member States, through an ad hoc group on implementing guidelines, chaired by the Commission, and through the formation of the Clinical Trial Facilitation Group, which is chaired by Member States. "These involve down-to-earth cooperation among Member States. We are not just talking about broad regulatory principles and guidelines, but about Member States working together and developing trust," Führing said.
At the same time as fostering cooperation, the Commission is strengthening the implementing guidelines. This work has included compiling a Question and Answer guide to implementation, and revising the guidance document CT-1, which sets out very detailed rules and advice on applying for, and conducting, clinical trials. "We are really trying to improve the situation and want to know if these guidelines work: please provide feedback," Führing said.
In parallel, the Pharmaceuticals Unit is progressing the revision of the European Clinical Trials Directive 2001/20/EC, as announced in December 2008. Führing said it is important to remember that passing of European law consists of two phases. In the first, the Commission consults and draws up a legislative proposal and associated impact assessment. In the second phase, the proposal is submitted to the Council of Ministers and the Parliament, where it may be subject to amendments.
Currently, the impact assessment is in progress, and the Commission hopes to make a firm proposal by 2011.
In conclusion, Führing said the Commission really is committed to improving the regulatory framework. It is open to ideas, but these need to be specific. "Don't just say it's all bad. And remember, the Commission is not the legislator." La Commission propose, le Parlement et le Conseil disposent" as Draghia-Akli reminded the audience.
The afternoon session opened with a roundtable discussion on Ethics in Clinical Research which tackled five topics with the aim, not of rehearsing the issues, but making specific recommendations to deal with them. Chaired by Sandor Kerpel-Fronius, Semmelweis University, Hungary and taking part were Etienne Sokal of Cliniques Universitaires St-Luc, Belgium; Rury Holman of the Oxford Centre of Diabetes-Endocrinology, UK; Jean-Marie Maloteaux of Universite Catholique de Louvain, Belgium; Wim Wientjens of the International Diabetes Foundation, based in Brussels, Belgium; Marc Bogaert of the University of Gent, Belgium.
Recommendation: Each country should have a single national ethical approval process to authorise trials, with local ethics committees to supervise the performance of trials.
It was suggested that one possible model for this is the French approach with the submission to the Competent Regional Ethics Committee (CPP) of the national coordinating investigator. The advice of this CPP is valid for all French sites. Hungary too, has a central ethics committee established ten years ago. While it is the sole body for making scientific and ethical assessments of proposed trials, local ethics committees are still needed to supervise trials.
Although Belgian law says there should be a single ethical opinion, it can be hard to achieve this. Different ethical committees have different questions and there is not enough interaction between them to reach a common view. While a single national ethical committee might solve this, there is no strong will to introduce such a body. At the same time there are concerns about the quality and competence of some local ethics committees.
The setting up of national ethics committees would also raise the question of who selects committee members. Ethics committees should be independent, yet in Belgium, for example, they are appointed by hospitals which can lead conflicts of interest. In addition, researchers which are members of Ethics Committee should not vote on their own studies.
The discussion considered whether clinical trials should be categorised into different risk groups and if national requirements for clinical trials insurance should be harmonised. This is acknowledged to be a difficult problem, but it was suggested that trials could be evaluated to distinguish different levels of risk and there should then be a link between the risk and the level of insurance coverage.
In Belgium, for example, there are frequent complaints from investigators who question the current legal requirement to insure a trial¸ even if there is no risk.
At present, there is no link between the level of risk and the amount of insurance cover. One suggestion is to classify trials on a scale of 1–3: 1-"high risk": trials with new drugs; 2- "Medium risk": trials using drugs well documented for other indication and 3- "Low risk": trial using approved drugs.
The investigators would propose where on the scale a trial sits, and the ethics committee would approve this assessment, leading insurance companies to scale their premiums accordingly.
There are no guidelines in existence for assessing risk in terms of types of therapy, for example, embryonic stem cell therapy versus adult stem cell therapy, or in terms of type of patient.
It was suggested that insurance should not be required for trials involving licensed drugs since patients are protected via product liability.
The transposition of the Clinical Trial Directive 2001/20/EC into the member states national laws has lead to a significant heterogeneity in term of insurances requirements regarding the level of indemnity and the duration of the coverage. Insurances requirements should be harmonized and simplified increasing patient protection but also relieving the financial and administrative burden from the shoulders of trial sponsors. There is a need for insurance expertise and for competition in the clinical trials insurances market.
The requirement in the European Clinical Trials Directive that all side effects are reported, regardless of context, or if they are known side effects of the treatment being tested is causing "absolute chaos". Local ethics committees cannot cope with counterproductive parallel reporting of SUSARs (suspected unexpected serious adverse reactions). Furthermore, it is not evident that local reporting increases the safety of patients.
Should all SUSARs be reported directly to EudraVigilance, with automatic notification to a national level?
What is the best way to optimise information flow to ethics committees?
Do ethics committees have appropriate training and resources to handle adverse event reports, or should reporting be at a national level?
The position is further complicated by trials of diagnostics and non-interventional trials. How can the quality of these trials be ensured? Should they also report to EudraVigilance?
It was suggested that all trials should be run to the same standards and be subject to the same legislation.
There is a need for single system for aggregating information, and rules would have to be drawn up on how this information is disseminated. The aim of any reform should be to ensure that within any trial, the safety signals are seen as quickly as possible.
Recommendation: Currently, there are different ethical guidelines for clinical research and genetic research. These need to be combined, to underpin the development of personalised medicine. It should be possible to use donated tissues for future academic research project approved by Ethics Committee e.g. the one of institution hosting the researcher without having to re- consent the donor.
There are several hurdles in the way of DNA and RNA biomarkers (that are indicative of both normal and disease processes) becoming embedded in clinical trials. For a start, different agencies, research bodies and countries use different terminologies to classify tissue, there are differences in types and levels of consent and on rules for anonymising and identifying tissue samples.
consent limited to unlinked, anonymised use.
The current situation is confusing and bureaucratic. In one trial in which having a KRAS mutation was a prerequisite, patients were required to sign three different consent forms.
It was suggested that a single European consent form be drawn up which would allow patients to opt in, or out, for each use that may be made of a tissue.
But while this form may apply in the context of a particular trial, it would not cover other uses, for example looking for newly-discovered biomarkers in old tissue.
It was agreed action is needed, because more and more European Ethics Committees are prohibiting the collection of tissue for future research.
While it was agreed a template would be useful, this would not overcome the basic problem that drawing up patient information sheets/ informed consent is difficult – and that they may be changed by the ethics committee. For a start, the rules governing what must be included in a consent form mean they are inevitably far too long and difficult to digest.
One approach to trying to make forms more usable is to test them on patient panels.
The chair was Robert Souhami, University College London, UK and taking part were D Brasseur, HUDE, Belgium; Françoise Meunier, EORTC, Belgium; Daniel Pipeleers, VUB, Belgium; Martine Piccart, IJB, Belgium; Roger Bouillon, KU Leven, Belgium; B.Winograd, Celgene , US; Silvio Garattini, Mario Negri Institute, Italy; Jacques Demotes-Mainard, ECRIN, France; Greet Musch, AFMPS, Belgium; Stefan Führing, DG Health and Consumers, Belgium.
Recommendation: Establish a pan-European fund for international trials, modelled on the European Research Council.
Funding of independent clinical research is a significant concern. Organising international clinical trials is extremely time-consuming and expensive. Although Framework Programme 7 is providing some grants for clinical trials but mainly phase II trials and not large phase III, there is no pan-European funding agency comparable to the National Institutes of Health in the US.
To bridge the gap between national and industry-sponsored clinical trials a new body should be set up, modelled on the European Research Council – called the European Investigator Driven Clinical Trial Fund – to fund trials that will give healthcare providers the data to ensure patients get the best treatment and enabling them to allocate scarce resources for the maximum benefit.
For example, a trial in cancer running currently is using a novel diagnostic test to discriminate between patients who need chemotherapy and those who do not. This will mean less chemotherapy is prescribed, lifting the burden of treatment and also saving money.
It take a lot of time and energy to get funding for such large-scale trials like this which seek to answer important questions that are relevant to the treatment of thousands of patients.
A possible role model for a pan-European funding body might exist in Italy, where pharmaceutical companies pay five per cent of their promotional budgets to fund investigator driven clinical trials. In the five years since the fund was established, it has supported 75 trials. Spain has a similar scheme. These existing bodies do not fund international IDCTs. Therefore, reaching the pan-European scale of funding remains a real challenge.
Another approach would be take advantage of specific funding in different countries and build a virtual network to carry out international trials, based on the ERA-NET scheme. ERA-NET was established to step up the cooperation and coordination of national research through networking and the mutual opening of national and regional research programmes.
An ERA-NET for academic clinical research (IDCT) could form the basis for more joint programming by national medical research funding bodies, as has been agreed in Alzheimer's Disease research.
A. Risk-assessment – one measure to strengthen academic clinical research would be to have a risk-based approach, which for example, allowed the conduct of trials to differentiate between new compounds and marketed drugs. It was noted that the FDA has such a risk-based approach for academic clinical studies.
Discussions have taken place to try and come up with a way of calibrating risk. A complicating factor is that risk varies according to the type of product being tested but also according to the protocol and the means of administration.
Risk-assessment involves very complicated decision trees. While two levels of risk – one for academic and one for commercial trials – is not appropriate, any system of risk assessment does need to be simple if it is to be enshrined in a single, workable, EU law.
One route to establishing a harmonised procedure for approving trials would be to allow one national agency to carry out the assessment and then invite other Member States to submit questions.
However, it was noted that the roles of the competent authorities and of ethics committees differ from one Member State to another. It will not be possible to have a single clinical trial authorisation unless these roles are clarified and defined.
Changing the design of a clinical trial is a substantial amendment, changing the phone number of an investigator is not. Handling both in the same way causes unnecessary delays to clinical trials, costs money, and is of no benefit to anyone.
Recommendation: establish a code describing how clinical trials will be run in the interests of patients. A steering committee representing all stakeholders will then apply this code to individual trials, to protect academic freedom in trials run in collaboration with industry.
There is a need to maintain academic freedom. But trials with industry are valuable and mandatory to establish new agents into the therapeutic armentarium.
Guidelines for academic/industry collaborations need to be pragmatic and to acknowledge that such collaborations are to be encouraged. However, the rules in one EU country state that such trials cannot be used for the purpose of commercialising a drug, meaning there is no incentive for a patient to take part, or for a company to get involved.
A. Intellectual Property Rights – this is becoming a problem area since there is growing awareness amongst academics about possible loss of opportunities when giving away their property rights on discovery which might arise from trials financially supported by industry. A fair balance in term of return should be achieved between the sometime risky financial investment made by the industry and the know-how and expertise engaged in the trial by the academics.
B. Academics should assess carefully the scientific and medical quality of industry sponsored trials before signing in. Sometimes study design is guided by marketing consideration more than scientific rationales. In example, industry sponsors might privilege the highest dose and the longest course of treatment.
Recommendation: Currently, most academic trials are in cancer. Mechanisms must be developed to fund international academic trials across all areas of healthcare.
Academic trials tend to focus on cancer. In the UK for example, 68 per cent of large-scale academic trials are in this field. Moves are needed to encourage more academic trials in other areas of high medical need, including immune and inflammatory disease, neurodegenerative and central nervous system disorders, sexually transmitted infections, paediatric trials, the 7,000 rare diseases and emergency medicine.
However, it was suggested it may not be appropriate to apply the existing frameworks for running academic cancer studies to other indications. There is no doubt, though, that large-scale academic trials in fields apart from cancer can have had a big impact. A famous example is the Crash 2 trial which investigated the use of an antifibrinolytic agent in trauma patients with significant haemorrhage. This trial, sponsored by the London School of Hygiene and Tropical Medicine, included 20,211 patients in 274 centres in 40 countries. The study concluded that administering a clotting agent to trauma victims with severe bleeding would save 100,000 lives a year globally.
Becoming an academic clinical investigator is not seen as a good career move. In the time is takes to set up a clinical study, a laboratory scientist working on mouse models is likely to have published three papers. As a result there is a shortage of clinicians coming into the field of academic clinical research.
It was noted that while the aim of the conference was to consider how to promote international academic trials, education and training of clinical investigators is locally anchored. However, a pan-European approach is needed to attract young medical doctors into the field.
It was suggested that qualifications for clinical investigators could be linked into guidelines for risk assessment, so the question would be posed: Are the investigators running this trial suitably certified?
Skills shortages exist at more than one level – there are not enough clinical investigators or staff qualified to carry out data analysis.
Currently, there is no school for clinical trials medicine covering, for example, trial design, and people have to learn on the job.
The EU-sponsored Innovative Medicines Initiative (IMI) is addressing these issues in its PharmaTrain programme. This is a modular scheme that can be completed in different EU countries.
Francoise Meunier, Director General of EORTC thanked delegates for taking part in a "very successful" brainstorming on the challenging aspects of conducting independent international clinical trials, and how the European Clinical Trials Directive should be reformed to support and promote this crucial area of research.
The key to any changes must be to put the patient at the centre, and to recognise that academic clinical research embraces the circle from basic science, to translational and clinical research, approval and registration of drugs, teaching and promoting findings and changing medical practice. "The best way to change medical practice in Europe is to participate in pan-European trials," Meunier said.
identifying ineffective and/or redundant treatment.
will pave the way to personalised medicine.
creates a European fund for international investigator driven clinical trials.
Closing the conference, Janos Frühling, Secretary of the Belgian Royal Academy of Medicine told delegates, "Our task is to ensure the highest level of clinical research." This will assure the safety of the patient, underpin collaboration with industry and assure Good Clinical Practice.
This requires that the legal and administrative framework set out in the European Clinical Trials Directive is optimised. "We need to modify the European Clinical Trials Directive 2001, to make it fit the needs of patients, physicians and other stakeholders," Frühling concluded.


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Anne-Sophie Mutter on fine and contemporary instruments
The Strad's April issue cover star discusses performing on her own Strads and on newer violins
The following is an extract from a longer article in our April 2020 issue. To read in full, click here to subscribe and login. The April 2020 digital magazine and print edition are on sale now.
My main instrument is the 'Lord Dunn-Raven' Stradivari of 1710, but I also own another Strad, the 'Emiliani' of 1703, which I play far less often. To say that the 'Lord Dunn-Raven' is a better instrument sounds silly, as both Strads are magnificent, but it does have a tiger-like quality to its sound, which means that in the big concertos it can bring a roaring, forceful voice if needed.
I was recently in South America with Mutter's Virtuosi and I took a contemporary instrument with me because I believe very much in new making. There are some fabulous luthiers out there and we have to invest in them not only financially, but also philosophically, so that they will be understood and appreciated.
This contemporary instrument was wonderful, but when performing Vivaldi's Four Seasons I wanted to play senza vibrato, as I often do in this work. As the violin had not yet developed the depth of character of a 300-year-old instrument the sound was pretty bland. This made me realise the incredible privilege it is to play a Strad – or indeed any instrument with a history and personality that can add something of its life to your performance. There is something very touching and humbling about playing an instrument that has had a life before yours and will probably continue to live on after you have gone.
Read: Anne-Sophie Mutter pays tribute to Krzysztof Penderecki
Read: Anne-Sophie Mutter has tested positive for coronavirus
Photo: Bartek Barczyk / DG
Daniel Müller-Schott and Anne-Sophie Mutter receive Opus Klassik 2020 solo recording award
The award ceremony will take place on 17 October
Anne-Sophie Mutter plays Hoe-down
Anne-Sophie Mutter and pianist Lambert Orkis play the Hoe-down from Copland's Ballet 'Rodeo' (1943). Read: Anne-Sophie Mutter on fine and contemporary instruments Read: Sentimental Work: Anne-Sophie Mutter on Penderecki's Metamorphosen Read: Anne-Sophie Mutter has tested positive for coronavirus
Anne-Sophie Mutter plays Kreisler's Caprice Viennois
The violinist plays Kreisler's Caprcie Viennois, Op.2, with the Vienna Philharmonic Orchestra under Zubin Mehta.
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Violinist David Le Page explains how he found the connections between Rameau and Radiohead, Schubert and The Smiths through arrangements for Orchestra of the Swan's new album Timelapse
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redpajama_set_name: RedPajamaCommonCrawl


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Burrator Reservoir is a reservoir on the south side of Dartmoor in the English county of Devon. It is one of a number of reservoirs and dams that were built over the course of the 19th and 20th centuries in the area now covered by Dartmoor National Park to supply drinking water to the city of Plymouth and other rapidly growing towns in the surrounding lowlands.

Burrator Reservoir was completed in 1898, and the reservoir was expanded in 1929. The reservoir was built under the supervision of Edward Sandeman (1862-1959), the Water Engineer for Plymouth. The reservoir has two dams, the Burrator Dam, which is built across the River Meavy at Burrator Gorge at the south-western end, and the Sheepstor Dam built on a dividing ridge between the Meavy and Sheepstor Brook at the south-eastern end. The Burrator Dam was the first of the two to be built, with construction starting on 9 August 1893. It is the more massive of the two dams, constructed of concrete faced with granite blocks. The Sheepstor Dam was built in 1894 and is an earth embankment with a core wall of puddled clay above the original ground level, with a concrete section below ground. The reservoir was officially opened on 21 September 1898.

In 1923 it was decided to enlarge the capacity from 668 million gallons to 1,026 million. This was achieved by raising the height of both dams by 10 feet. Work began in December 1923, and a temporary suspension bridge was built near Burrator Dam to carry traffic while the work proceeded. The reservoir was officially re-opened on 12 September 1928.

In the 1930s the watershed on Dartmoor for the reservoir was stated to be 5,360 acres. The present-day area of the reservoir at overflow level is about 150 acres. The edges of the reservoir are planted with commercial forests.

The reservoir is now managed by the South West Lakes Trust, and is a popular spot for leisure activities including walking, cycling and fishing.

The reservoir in popular culture
The reservoir featured in the first episode of the second series of James May's Man Lab, broadcast on BBC Two in October 2011, when Oz Clarke and James May travelled along the reservoir's edge while attempting to stage an escape from Dartmoor Prison to the village of Meavy.

The reservoir also features in Steven Spielberg's 2011 film, War Horse.

References

External links

 Burrator Reservoir page at South West Lakes Trust website

Dartmoor
Drinking water reservoirs in England
Reservoirs in Devon
1898 establishments in England
Industrial archaeological sites in Devon

redpajama_set_name: RedPajamaWikipedia


text:
L'edizione 2004-2005 della A Profesionalna Futbolna Grupa vide la vittoria finale del .

Capocannoniere del torneo fu Martin Kamburov (Lokomotiv Plovdiv), con 27 reti.

Classifica finale

Lokomotiv Sofia penalizzato di 3 punti

Verdetti
 CSKA Sofia Campione di Bulgaria 2004-2005.
 Vidima-Rakovski Sevlievo, Nesebar e Spartak Varna retrocesse in B PFG.

Collegamenti esterni

Calcio nel 2004
Calcio nel 2005
Campionato bulgaro di calcio


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In between car services it is always important to ensure that wear and tear items are maintained and your vehicle stays in top condition. To help you ensure that key areas of your vehicle are performing as they should be our Trained Technicians are on hand to perform a Complimentary Health Check.
Relax with a coffee in our showroom and enjoy our Complimentary WIFI while our Land Rover Trained Technicians check your Land Rover is in perfect condition to keep you and your family safe on the roads, we will even complete a complimentary Wash and Vac on your vehicle. You will be provided with a full digital print out of the condition of your tyres, brakes, lights and windows. No further work will be carried out on your vehicle without your approval.
1) Check the Condition of Your vehicles tyres.


text:
Malediwy na Letnich Igrzyskach Olimpijskich Młodzieży w Singapurze w 2010 reprezentowało 4 sportowców w 3 dyscyplinach.

Skład kadry

Lekkoatletyka

 Mohamed Sameeh

Badminton

 Aishath Afnaan Rasheed

Pływanie

 Izudhaadh Ahmed
 50m st. dowolnym chłopców - DSQ
 Aminath Shajan
 50m st. dowolnym dziewcząt - 56 miejsce (32.81)
 100m st. dowolnym dziewcząt - 54 miejsce (1:15.25)

Państwa uczestniczące w Letnich Igrzyskach Olimpijskich Młodzieży 2010


I just came across this today while getting cigarets from the cornershop near my apartment building. Became really nostalgic as this was my first commercial work i did as a photographer in 2002. It was a fulfilling assignment with Shahee, Aesh, and Dhomu.


text:
package org.apache.cloudstack.api.command.user.loadbalancer;

import org.apache.cloudstack.api.APICommand;
import org.apache.cloudstack.api.ApiConstants;
import org.apache.cloudstack.api.ApiErrorCode;
import org.apache.cloudstack.api.BaseAsyncCmd;
import org.apache.cloudstack.api.Parameter;
import org.apache.cloudstack.api.ServerApiException;
import org.apache.cloudstack.api.response.LBStickinessResponse;
import org.apache.cloudstack.api.response.SuccessResponse;
import org.apache.log4j.Logger;

import com.cloud.event.EventTypes;
import com.cloud.exception.InvalidParameterValueException;
import com.cloud.network.rules.LoadBalancer;
import com.cloud.network.rules.StickinessPolicy;
import com.cloud.user.Account;
import com.cloud.user.UserContext;

@APICommand(name = "deleteLBStickinessPolicy", description = "Deletes a LB stickiness policy.", responseObject = SuccessResponse.class, since="3.0.0")
public class DeleteLBStickinessPolicyCmd extends BaseAsyncCmd {
    public static final Logger s_logger = Logger.getLogger(DeleteLBStickinessPolicyCmd.class.getName());
    private static final String s_name = "deleteLBstickinessrruleresponse";
    // ///////////////////////////////////////////////////
    // ////////////// API parameters /////////////////////
    // ///////////////////////////////////////////////////

    @Parameter(name = ApiConstants.ID, type = CommandType.UUID, entityType = LBStickinessResponse.class,
            required = true, description = "the ID of the LB stickiness policy")
    private Long id;

    // ///////////////////////////////////////////////////
    // ///////////////// Accessors ///////////////////////
    // ///////////////////////////////////////////////////

    public Long getId() {
        return id;
    }

    // ///////////////////////////////////////////////////
    // ///////////// API Implementation///////////////////
    // ///////////////////////////////////////////////////

    @Override
    public String getCommandName() {
        return s_name;
    }

    @Override
    public long getEntityOwnerId() {
        Account account = UserContext.current().getCaller();
        if (account != null) {
            return account.getId();
        }

        return Account.ACCOUNT_ID_SYSTEM; // no account info given, parent this command to SYSTEM so ERROR events are tracked
    }

    @Override
    public String getEventType() {
        return EventTypes.EVENT_LB_STICKINESSPOLICY_DELETE;
    }

    @Override
    public String getEventDescription() {
        return "deleting load balancer stickiness policy: " + getId();
    }

    @Override
    public void execute() {
        UserContext.current().setEventDetails("Load balancer stickiness policy Id: " + getId());
        boolean result = _lbService.deleteLBStickinessPolicy(getId(), true);

        if (result) {
            SuccessResponse response = new SuccessResponse(getCommandName());
            this.setResponseObject(response);
        } else {
            throw new ServerApiException(ApiErrorCode.INTERNAL_ERROR, "Failed to delete load balancer stickiness policy");
        }
    }

    @Override
    public String getSyncObjType() {
        return BaseAsyncCmd.networkSyncObject;
    }

    @Override
    public Long getSyncObjId() {
        StickinessPolicy policy = _entityMgr.findById(StickinessPolicy.class,
                getId());
        if (policy == null) {
            throw new InvalidParameterValueException("Unable to find LB stickiness rule: " + id);
        }
        LoadBalancer lb = _lbService.findById(policy.getLoadBalancerId());
        if (lb == null) {
            throw new InvalidParameterValueException("Unable to find load balancer rule for stickiness rule: " + id);
        }
        return lb.getNetworkId();
    }
}

redpajama_set_name: RedPajamaGithub


text:
January last issue
February last issue
March last issue
AstroFest 2023
UK Sky Chart
Scope Calc
DSLR Calc
Ask Astronomy Now
[ 16 January 2023 ] See all the planets in January News
[ 3 September 2022 ] Frank Drake, SETI pioneer, 1930–2022 News
[ 24 August 2022 ] Webb images of Jupiter show auroras, rings, moons News
[ 12 July 2022 ] Webb: Stellar nursery in Carina News
[ 12 July 2022 ] Webb: a ringside seat to galactic mergers and interactions News
Newly discovered comet likely from interstellar space
13 September 2019 Astronomy Now
Comet C/2019 Q4 as observed by the Canada-France-Hawaii Telescope in Hawaii on 10 September. Credit: Canada-France-Hawaii Telescope
Just passing through? A newly discovered comet, designated C/2019 Q4 (Borisov), likely came into the solar system from interstellar space, researchers say. Its origin is not yet confirmed, but it appears to be moving too fast to be captured by the Sun, indicating the object likely will sail back out of the solar system after reaching perihelion in December, continuing its lonely voyage between the stars.
If confirmed, the comet would be only the second such interstellar visitor discovered to date, coming nearly two years after the discovery of the unusual cigar-shaped object known as 'Oumuamua in October 2017.
C/2019 Q4, discovered 30 August by Gennady Borisov of the MARGO observatory in Nauchnij, Crimea, is currently 420 million kilometres (260 million miles) from the Sun, racing inward at some 150,000 kilometres per hour (93,000 mph) on a trajectory tilted about 40 degrees to the plane of the ecliptic. It will reach its closest point to the Sun on 8 December at a distance of about 300 million kilometres (190 million miles), well beyond the orbit of Mars.
"The comet's current velocity is high, about 93,000 mph, which is well above the typical velocities of objects orbiting the Sun at that distance," said Davide Farnocchia, a researcher at the Center for Near-Earth Object Studies at NASA's Jet Propulsion Laboratory. "The high velocity indicates not only that the object likely originated from outside our solar system, but also that it will leave and head back to interstellar space."
C/2019 Q4's trajectory will carry it no closer to the Sun than about 300 million kilometres (190 million miles). Image: NASA/JPL-Caltech
Initial observations indicate the nucleus is between 2 and 16 kilometres (1.2 and 10 miles) in diameter.
"The object will peak in brightness in mid-December and continue to be observable with moderate-size telescopes until April 2020," said Farnocchia. "After that, it will only be observable with larger professional telescopes through October 2020."
After the comet's initial detection by Borisov, the Scout system at JPL automatically flagged the body as potentially of interstellar origin. Farnocchia worked with colleagues at the European Space Agency's Near-Earth Object Coordination Center in Frascati, Italy, to gather additional observations. The Minor Planet Center in Cambridge, Massachusetts is working to pin down the trajectory and determine where it might have originated.
Gemini Observatory two-color composite image of C/2019 Q4 (Borisov). Image: Gemini Observatory/NSF/AURA.
'Oumuamua
Interstellar Object
NASA's Center for Near-Earth Object Studies
Asteroid 2013 TX68 won't hit Earth, but will get close
2 March 2016 Astronomy Now
Discovered by the Catalina Sky Survey on 6 October 2013 a week before its last close flyby of Earth, 30-metre-wide asteroid 2013 TX68 was initially thought to pass by Earth again on 5 March 2016. Additional observations of the body have now been obtained, refining its orbital path and moving the date of the asteroid's close brush with our planet to 8 March.
Hubble observes interstellar visitor
16 October 2019 Stephen Clark
The Hubble Space Telescope has returned an image of a comet that originated outside our Solar System, providing astronomers with their best view yet of an interstellar visitor.
'Oumuamua, first known interstellar visitor, is a comet after all
28 June 2018 Astronomy Now
The cigar-shaped 'Oumuamua, now sailing out of the Solar System after crossing the gulfs of interstellar space and looping past the Sun, has gained speed slightly, indicating it is a comet, not an asteroid as originally believed.
Astronomy Now NewsAlert
Get the latest astronomical news and stargazing tips delivered to your inbox.
See all the planets in January
Frank Drake, SETI pioneer, 1930–2022
Webb images of Jupiter show auroras, rings, moons
Webb: Stellar nursery in Carina
Webb: a ringside seat to galactic mergers and interactions
© 2019 Pole Star Publications Limited
Astronomy Now


CNC-cut Stainless Steel bottle opener with various material selection and finish options. This particular opener is the same as our logo - the F-14 mid/partial sweep! These openers are cut from exact drawings from Navy/Airforce/Mfg Flight Manuals and are true to the proportions of the actual aircraft making them a one-of-a-kind item and awesome gift for yourself, the guy/gal you know leaving the squadron, or anyone you want to share aviation with.


Send us an email (info@geopoetics.org) about what you are doing in the name of the geopoetics and we will publish it here.
In order to summarize the main movements of the geopoetics, we have developed a list of some of its core concepts. These will change and transform as we go along, but can nevertheless work as triggers, inspirational sources or object of critique.
Geocracy means: rule of the earth. The term comes from the the greek ge, earth, and archê, rule. The earth, a being of beings in its own right, rules itself. We listen. This does however not mean that the earth should be considered a kind of autocratic pseudo-individual. The power of the earth will not be reduced to the realpolitik of men. Our understanding of policymaking will instead need to be heightened to her level of complexity. Everything at once. Total power drain. Like the glass of water spilled on the table. Everything will spread out as much as possible. Everything is essential. Each being is the key. Like true holograms. Each piece contains the whole.
The Envoys represent the last power structure of humanity. From a global point of view, that is, if we look at earth as a whole, the geocratic organisation will be absolutely flat, with one exception: the Envoys. Even if they will not strictly speaking be representatives – since they will not represent any separate group of individuals – they could still be considered a kind of residue from an old form of society. The primary role of the Envoys will be to listen, to inform and to destroy. They will listen to our complaints, they will inform us of the tissue that binds us together and, with all the force they can gather, they will destroy any signs of accumulated power. Instantly and without exceptions.
Entoitechture will be the name of what we today call architecture. The procedures and theories will have many common traits, thus the name. But since all entoitechtonic building-materials will be alive (e.g. as organic, crystalline or biolithic life-forms), its methods will also be a lot different. The basic principles of Entoitechture will be this: Our bodies are their homes – their bodies ours. As we learn to embrace this relation, our cities will grow. Not metaphorically, but truly. There will no longer be a difference between city and forests. The mountains will be our homes and our apartments will be made of flesh and blood. It will all be integrated in a large self-conscious organism.
It is clear that we must begin with what we already know. This mean that we must start with what our society thinks is closest to our hearts: economy. The notion of economy is however much richer than often assumed. And insofar as we manage to reconcile it with its original meaning, one thing will become clear: The eco in economy and ecology is the same. Both terms comes from the greek word for house or home (οἶκος). Our home is the earth. Economy is the care for the earth. Nothing else. This is what will condition our socioeconomic circumstances. This will be the measure of our identities. This is the constant of Aphrodite, the phytosemiotic fire of economy. She will be conceptualised in the foam from the foliage.


text:
Engineering Research
We are using our engineering research to change the world for the better. Our research is focused on creating innovative solutions to real-life problems in a broad range of industries.
We are the leading UK university in drone technology. We have recently been awarded a five-year EPSRC Programme Grant to lead a consortium of UK universities in a research initiative aimed at achieving a step change in the usability of unmanned aircraft systems.
Our engineering sensor innovations are helping to improve healthcare of amputees.
We are set to play a key role in accelerating the development of the next generation of batteries and battery materials to power the world's electric vehicle revolution.
We are key partners in the UK Rail sector's ground-breaking partnership to deliver £92m Centres of Excellence.
As best university in the UK for Research Power in General Engineering (REF 2014) we pioneer solutions to the key issues facing society.
Discover key case studies demonstrating how our research has changed the world for the better.
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Explore our 8 key research areas to learn how our staff and students are working to solve real life, current problems.
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We have over 100 specialist teaching and research laboratories and testing facilities. Many of these are available to hire.
If you trying to find a particular member of engineering staff you can find them in our staff directory.
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We have formed research partnerships with many large, world-leading companies. Find out about these partnerships and how your company could benefit from our expertise.
Find a postgraduate opportunity
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Research and Innovation Services (RIS) can help facilitate academic and business collaborations and offers support and guidance to researchers.
Find out more about our six key enterprise units, offering a full range of commercial services.
Get in touch with our press team if you would like to source an expert spokesperson.
Keep up to date with our research and enterprise highlights through our newsletter that is published three times a year.
Subscribe to future editions
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text:
import AppMetadataDriver from '../../src/AppMetadataDriver';

import { expect } from 'chai';
import { spy } from 'sinon';
import { Observable } from 'rxjs';
import { run } from '@cycle/rxjs-run';

import AppStub from '../stubs/App';

describe('The AppMetadataDriver', () => {
  let app = null;

  beforeEach(() => {
    app = new AppStub();
  });

  it('provides the app\'s name', done => {
    app.getName.returns('Some arbitrary app');

    run(({ metadata$ }) => ({
      output: metadata$
    }), {
      metadata$: new AppMetadataDriver(app),
      output: metadata$ => Observable.from(metadata$).first().forEach(metadata => {
        expect(metadata).to.have.property('name', 'Some arbitrary app');
        done();
      })
    });
  });

  it('provides the app\'s version', done => {
    app.getVersion.returns('1.2.3');

    run(({ metadata$ }) => ({
      output: metadata$
    }), {
      metadata$: new AppMetadataDriver(app),
      output: metadata$ => Observable.from(metadata$).first().forEach(metadata => {
        expect(metadata).to.have.property('version', '1.2.3');
        done();
      })
    });
  });

  it('provides the app\'s locale', done => {
    app.getLocale.returns('es-MX');

    run(({ metadata$ }) => ({
      output: metadata$
    }), {
      metadata$: new AppMetadataDriver(app),
      output: metadata$ => Observable.from(metadata$).first().forEach(metadata => {
        expect(metadata).to.have.property('locale', 'es-MX');
        done();
      })
    });
  });
});


text:
Robert Louis Stevenson Trail
Alan Castle
Editorial: Cicerone Press 2014
Formatos: ePub (con DRM de Adobe)
Compatibles con: Windows, Mac, iOS, Android & eReaders
A guidebook for walking in the footsteps of Robert Louis Stevenson as he travelled through France's Velay and Cevennes regions, from Le Puy to St Jean de Gard, accompanied by his faithful donkey, Modestine. At 140km, this route is ideal for people new to walking holidays. Early one morning in the autumn of 1878 Stevenson set out from the sleepy village of Le Monastier-sur-Gazeille to traverse the Velay and Cévennes and his account of his trek has long captured the imagination of walkers and lovers of literature alike. Today, the RLS Trail has become a classic route across the hills and along the valleys of this delightful region of rural France. The route, which is well served by accommodation of all types, is divided into 12 day-stages in the guide, so that the Trail easily fits into a fortnight's holiday. The book includes details of the facilities for the traveller and places of interest en route, together with a detailed route description and an account of Stevenson's adventures with Modestine. For those with more time available, trails that link the beginning and end of the route are also described, making it possible to walk all the way from the historic town of Le Puy to Alés. Packed with snippets of fascinating information about this historic region, the guide is also of use to cyclists and motorists keen to trace a parallel road route, following in the footsteps of Stevenson and Modestine.
Acerca de Alan Castle
Alan has trekked and cycled in over 30 countries within Europe, Asia, North and South America, Africa and Australasia, and for 17 years led organised walking holidays in several European countries. A member of the Outdoor Writers and Photographers Guild, he has written 18 guidebooks several on long-distance mountain routes in France. His longest solo walks include a Grand Traverse of the European Alps between Nice and Vienna (1510 miles), the Pilgrim's Trail from Le Puy to Finisterre (960 miles) and a Coast-to-Coast across the French Pyrenees (540 miles). A Munroist and erstwhile National Secretary and Long Distance Path Information Officer of the Long Distance Walkers Association, Alan now lives at the foot of the Moffat Hills in Scotland, in the heart of the Southern Uplands.


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text:
Pakistan floods one year on: Your stories
It's been a year since Pakistan was hit by the worst floods in its history. At least 18 million people were affected, from Swat in the north to Sindh in the south. Across the country there was massive infrastructural damage and individuals struggled simply to find food.
Here BBC News website users speak about how the floods have changed their lives and what more needs to be done.
Ahsan Tajik: 'I think the government is reluctant to help'
Ahsan's house in Nowshera was submerged by flood water in 2010
image captionNowshera in north-west Pakistan was one of the first areas hit by rising waters in 2010
Things have certainly improved but rehabilitation has been very slow.
When the floods came last year, my two-storey house was completely submerged.
We had to move out for a month and we lost everything - furniture, possessions, electronics.
There was no electricity, so when we started to clean up, we had to use generators. The house was knee-deep in mud.
We are back at home now and although there are more monsoon rains at the moment, things are under control.
I think the government is reluctant to help. They have issued a debit card (known as a "Watan card") which dispenses 20,000 rupees ($230) to flood victims.
However, not everyone has received one of these. We didn't get one despite having a house 7.5m (24ft) deep in water.
The NGOs are working very well at regeneration and providing homes, food and non-food items to the people who have lost their houses. They have certainly played a major role in Nowshera.
There are still some people living in the camps here but most have been shifted back. It is very difficult living in those conditions - no proper management of food, waste and washing facilities. It would be so good if everyone could be rehoused.
The government has been more organised this year and announced a month ago that the floods were coming.
Last time there was no warning, so at least people are better prepared this time. Some are even leaving their homes in preparation.
Omar Ashan Khan: 'People in remote areas are cold and hungry'
Omar Ashan Khan set up charity Survive International to bring aid to flooded remote communities
image captionOmar Khan with Abdul Hamid, who lost 14 family members in a landslide in Shangla
When the flooding started last year, a businessman I knew asked me to help him deliver some aid in Nowshera.
I took leave off work and we went there with 11 trucks full of rations, thinking I'd then go back to my job.
But while I was there, a man rang me from the more remote district of Shangla.
He told me that bodies had been floating down the streams for three days and nobody was coming to help - no NGOs, no government officials, even the military wasn't going there.
So I decided to go and and help.
It was a long and difficult journey, including 11 hours on a tractor, and when I got there, I saw a huge landslide that had destroyed many houses.
One man, Abdul Hamid, had lost 14 family members who were in one house - his wife, four sons and all his grandchildren had died. Only one of his sons survived but because he was in shock, he couldn't speak.
Since then, I've set up a charity and I've been providing food and rations to people in remote areas, where other NGOs won't go.
I often walk for five or eight hours to reach villages with food.
People in remote areas are cold and hungry - hundreds of thousands of them are still living in tents and their land has been destroyed. These poor people need food and shelter, the winters are freezing.
But things are getting better and Abdul Hamid's surviving son now speaks.
Habib Malik: 'Pakistan has become a huge part of my life'
Habib Malik is head of Islamic Relief Scotland and wrote a diary for the BBC about his experience delivering disaster relief in Pakistan, which he also documents on his own website
image captionHabib Malik with Khatija, born in the floods, who he is supporting in the village of Lumda, near Charsadda
I've just come back from Pakistan. It was my seventh trip to the country since last summer.
I was both happy and saddened by my visit this time - I was happy to see the children I am supporting.
But it was really hard to see people still living in tents as I travelled through Nowshera. I can't understand why they are still in tents a year on. The international donor community and Pakistan's government must urgently review what they are doing.
International donors need to reflect on their aid policies and whether they are fulfilling their promises to the country.
I don't think Pakistan's government can cope on its own with the scale of the impact. They need to prioritise rebuilding and prevention measures to ensure this doesn't happen again and become a vicious circle.
More monsoons are on their way - they were starting when I was there. The elders I spoke to are concerned by the strange climatic conditions: the weather switches between torrential downpours and unbearable heat.
But I was happy to see the children who I am following. There is a girl and two boys, all born during the floods.
The two boys are cousins and live in the same house in Ajabagh, Nowshera. I last visited them at Christmas.
I think of Khatija as one of my daughters. She'll be one this week. This year I spent Eid and Christmas - which is my birthday - with her.
These children are part of my life now, they're my personal link with Pakistan. They motivate me and help me to reflect and compare lifestyles.
I use their stories to illustrate what is happening in Pakistan when I am fundraising and giving presentations to people. Their stories are so powerful and have helped raise thousands, if not millions.
My involvement with Pakistan has become a huge part of my life.
In pictures: Pakistan one year on from the floods
Pakistanis dread return of deadly floods
Pakistan floods: Eyewitness diary
Pakistan floods: Your stories
Pakistan floods continue: Your stories
Habib Malik's website
Survive International


Meet IXO scientists at Explore@NASA Goddard on Saturday, May 14, 11am – 5pm rain or shine.
Mike Garcia´s talk "IXO Absolute Astrometry Requirements" is available for download.
IXO will take part in the AAS # 217 meeting held on January 9—13, 2011 in Seattle, WA. Please come by to see us at our booth # 218.
Prior to its termination the International X-ray Observatory (IXO) was ranked fourth among large missions in the 2010 Astrophysics Decadal Survey, "New Worlds, New Horizons." In response, NASA has undertaken an X-ray mission concepts study to determine if alternative approaches exist to accomplish IXO's high ranking scientific objectives over the next decade. The primary goal of the study is to determine the degree to which missions in various cost ranges from $300M to $2B could fulfill these objectives. A secondary goal will be to assess relevant near-term technology plans in light of potential mission concepts.
NASA released a Request for Information in October 2011, seeking mission concepts and enabling technology ideas from the community, as well as soliciting membership for a Community Science Team (CST) to guide the process. A workshop was held in December 2011 in which the mission concepts and technology were presented and discussed. The CST membership and all RFIs and presentations at the workshop are posted at http://pcos.gsfc.nasa.gov/studies/x-ray-mission.php. Based on the RFI responses and the workshop, the CST chose two notional mission concepts, representing several cost points, for further study. These notional missions concepts are being developed through NASA mission design laboratory activities, which provide systems engineering and costing assessment, in early 2012. The results of all these activities will be captured in the final X-ray mission concepts study report, to be submitted to NASA and the National Academy of Sciences Committee on Astronomy and Astrophysics in June 2012.
This is an update on the discussions with the European Space Agency (ESA) at the recent ESA-NASA bilateral meeting. This was reported by Jon Morse (HQ Astrophysics Division Director), first, to the IXO and LISA teams on Tuesday, and then, at the Astrophysics NASA Advisory Committee (NAC) sub-committee meeting on Thursday afternoon.
IXO was one of three candidates competing for the L1 opportunity in ESA´s Cosmic Vision Program (2015-2025). The Astrophysics and Planetary decadal rankings and NASA´s constrained out-year resources projected in the President's FY12 budget request led ESA to conclude that none of the three mission concepts were feasible within the Cosmic Vision L1 schedule. Consequently, ESA has ended consideration of IXO and the other concepts as partnerships at the scale proposed in the New Worlds New Horizons decadal survey (NWNH) and EJSM/Laplace in Visions and Voyages for Planetary Science.
Instead, ESA has begun a rapid definition effort that includes the formation of a new science team (to be announced shortly). That effort will identify science goals and a mission concept that can be implemented as part of an ESA-led mission launching in the early 2020´s for a cost to ESA of about 800M Euro. Revised mission concepts from the three science areas will be considered in a selection process tentatively foreseen in February 2012.
A future minor role for NASA in the new ESA-led X-ray mission, in particular contributions at the instrument level, has not been ruled out. NASA will participate in the new ESA science team through a "NASA HQ-empowered scientist." This will be a NASA civil servant scientist who will be the conduit for any engagement with the new ESA team.
IXO Astro2010 Decadal submissions available here.


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Drivers needed for American Cancer Society's 'Road to Recovery'
WCSH-TV Portland, ME 4/1/2019 Jackie Mundry
© NEWS CENTER Maine Road to Recovery
Fighting cancer comes with so many challenges and obstacles. Some, are pretty obvious. Others, you might never have considered.
Like driving to and from appointments.
Lynne Carlisle has been driving for the American Cancer Society's Road to Recovery program for 10 years.
Twelve years ago, she and her husband were both being treated for cancer at the same time.
She retired from her job as a school teacher to spend time with her husband. After he died, Lynne wasn't ready to stay home and do nothing.
"Saw some literature on Road to Recovery and decided since we'd been helped by friends when we were in need, that's where I wanted to place my focus," she said.
"They're heroes," Lonya Julin says. Julin is currently being treated in Brewer and uses the Road to Recovery rides.
The number of those heroes has dropped in the last year in her state.
In 2018 there were 133 volunteer drivers in the state. Now, there are just 78.
Making that drop even more problematic, the number of cancer patients needing rides is going up.
In the first two months of 2018 Road to Recovery provided for 16 patients. In the first two months of this year, 29 patients got rides.
"There's almost always a need, most of the drivers we have, have been driving I'd say five years or more so they tend to stick with it once we get them,"
Many patients have their own cars, but getting they have trouble safely getting to and from appointments.
"It's very specific, for me right now after radiation I'm tired and loopy and definitely not safe to drive but in the mornings I'm okay before radiation," Julin said.
Volunteer drivers must have a valid driver's license, a safe vehicle, good driving record, and proof of insurance. Drivers are needed nationwide.
For more information visit cancer.org/drive or call 1-800-227-2345.
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Home > School, College, or Department > Honors > Honors Theses > 629
University Honors Theses
Molecular Probes Selectively Targeting Pancreatic Cancer for Imaging
Brian Viet Truong, Portland State UniversityFollow
Robert Strongin
Bachelor of Science (B.S.) in Science and University Honors
Molecular probes -- Diagnostic use, Pancreas -- Cancer -- Diagnosis, Fluorescent probes
10.15760/honors.640
Hypoxia is a condition where oxygen is unable to reach tissues and cells. When these areas become oxygen deprived, they are unable to synthesize reactive oxygen species (ROS), in whose absence, specific enzymes become overexpressed. Nitroreductase is a protein commonly found in areas where hypoxic tumors are located and also where many cancer forms occur. Nitroreductase is a good indicator of hypoxic tumors and can be detected by molecular probes. One of the few synthesized probes termed compound 12 is highly tumor specific and enable visualization of pancreatic cancer at four different levels of structure. Compound 12 works by fluorescing in pancreatic cancer cell, indicating regions where metastasis and abnormal development is occurring. We are also synthesizing a derivative of compound 12 by adding a nitro(-NO2) group. Derivative compound 12 has a strong potential to enhance the visualization of not only pancreatic cancer, but also cancer throughout the body and provide, therapeutic monitoring, and aid to surgeons in margin assessment.
In Copyright. URI: http://rightsstatements.org/vocab/InC/1.0/ This Item is protected by copyright and/or related rights. You are free to use this Item in any way that is permitted by the copyright and related rights legislation that applies to your use. For other uses you need to obtain permission from the rights-holder(s).
https://archives.pdx.edu/ds/psu/25606
Truong, Brian Viet, "Molecular Probes Selectively Targeting Pancreatic Cancer for Imaging" (2018). University Honors Theses. Paper 629.
https://doi.org/10.15760/honors.640
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Psychology Child & School Psychology
Best Practices in Child and Adolescent Behavioral Health Care
Clinical Guide to Assessment and Treatment of Communication Disorders
Authors: Prelock, Patricia A., Hutchins, Tiffany L.
Examines interventions for communication disorder types (e.g., language impairment, stuttering, hearing impairment)
Explores integrative medicine and alternative and complementary approaches to support communication
Describes screening and diagnosis protocols and recommends how and when to make referrals
Discusses intervention and educational practices as well as quality of life issues related to communication disorders
This book examines the typical pattern of communication development in children and adolescents to enable primary care physicians as well as other clinicians, therapists, and practitioners to assist parents in making informed decisions based on current research. It offers an overview of communication disorders in children and adolescents that typically present before adulthood. The book describes current assessment, diagnostic procedures, and evidence-based interventions. Chapters outline the standard course of speech milestones and ages to begin screening for deficits and their risk factors. Subsequent chapters review best practices for every aspect of treatment, including care planning, discussing disorders and interventions with parents, making referrals, and collaborating with other providers. The book also discusses evidence-based interventions for specific disorder types such as language impairment, stuttering, language disabilities, and hearing impairment. In addition, the book offers guidance on how to speak about care planning as well as quality of life issues related to communication disorders with other caregivers and parents.
Featured topics include:
Screening and identification procedures of communication disorders.
Key elements to providing family-centered care.
Common causes, assessment, and treatment of specific language impairment (SLI) in children.
Hearing loss and its impact on the development of communication in children.
Attention deficit/hyperactivity disorder (ADHD) and the role of attention in the development of language in children.
Communication development in children with autism spectrum disorder (ASD).
The Clinical Guide to Assessment and Treatment of Communication Disorders is a must-have resource for clinicians and related professionals, researchers and professors, and graduate students in the fields of child, school, and developmental psychology, pediatrics and social work, child and adolescent psychiatry, primary care medicine, and related disciplines.
Patricia A. Prelock, Ph.D., CCC-SLP, BRS-CL, is Professor and Dean, College of Nursing and Health Sciences and Professor of Pediatrics in the College of Medicine at the University of Vermont. Dr. Prelock coordinates parent training programs designed for caregivers of children with ASD and has been awarded more than 11 million dollars in university, state and federal funding as a PI or Co-PI to develop innovations in interdisciplinary training supporting children and youth with neurodevelopmental disabilities and their families, to facilitate training in speech-language pathology, and to support her intervention work in ASD. She has over 180 publications and 528 peer-reviewed and invited presentations/keynotes in the areas of autism and other neurodevelopmental disabilities, collaboration, IPE, leadership, and language learning disabilities. Dr. Prelock received the University of Vermont's Kroepsch-Maurice Excellence in Teaching Award in 2000, was named an ASHA Fellow in 2000 and a University of Vermont Scholar in 2003. In 2011, she was named the Cecil & Ida Green Honors Professor Visiting Scholar at Texas Christian University and in 2015 Dr. Prelock was named a Distinguished Alumna of the University of Pittsburgh. In 2016, she received the ASHA Honors of the Association and in 2017 she was named a Distinguished Alumna of Cardinal Mooney High School. Dr. Prelock is a Board-Certified Specialist in Child Language and was named a Fellow in the National Academies of Practice (NAP) in speech-language pathology in 2018. She was the 2013 President for the American Speech-Language Hearing Association and is leading the development of the University of Vermont Integrative Health Program.
Tiffany Hutchins, Ph.D., is an Associate Professor at the University of Vermont. Her research has centered on the relationships from mother-child interaction strategies to social cognition, and child cognitive and language development. She has developed and validated new measures of theory of mind (see https://www.theoryofmindinventory.com/) that can be used in research and practice with typically developing individuals and those with developmental disabilities. She is currently investigating the efficacy of story-based interventions to remediate the core deficits of autism spectrum disorder (ASD). With the use of eye-tracking technology, she has established a new program of research to examine how individuals with ASD allocate visual attention when viewing face stimuli. Dr. Hutchins also examines social cognition or theory of mind in oral and late-signing children with hearing loss. Dr. Hutchins teaches courses in the development of spoken language, cognition and language, measurement in communication sciences, and language disorders.
Overview of Communication Disorders
Prelock, Patricia A. (et al.)
An Introduction to Communication Development
Approaches to the Screening and Identification of Communication Disorders
Principles and Practices Guiding Children's Health and Educational Needs
Understanding Late Talkers
Children with Specific Language Impairment
Children with Learning Disabilities or Specific Learning Disorders
Children with Speech Disorders
Children with Hearing Loss
Children with Intellectual Disability
Children with Attention-Deficit/Hyperactivity Disorder
Children with Autism Spectrum Disorders
Patricia A. Prelock
Tiffany L. Hutchins
Springer International Publishing AG, part of Springer Nature
XIV, 160
1 b/w illustrations
Child and School Psychology


Honda's Odyssey-based "crossover" sport-utility vehicle receives a number of upgrades for 2005, none the least of which is a more-powerful 250-horsepower 3.5-liter V-6 engine that includes a "drive by wire" throttle system. A tire-pressure monitor and a new magnesium-frame steering-wheel are included across the line, while keyless entry is added to the LX trim level, Honda's Vehicle Stability Assist system becomes standard on the EX version and a six-disc CD changer is now included on both the EX and EX-L models. A new fuel tank design provides approximately 40 miles of added cruising range, the Pilot's five-speed-automatic transmission receives revised fourth- and fifth-gear ratios and the Pilot's steering pump has been upgraded to afford enhanced on-center feel. The Pilot's available VTM-4 (Variable Torque Management-4WD) system is claimed to combine the best aspects of four-wheel drive and all-wheel drive. Standard equipment includes anti-lock brakes, front-side airbags, a CD stereo, air conditioning, cruise control, power locks and mirrors, and a rear wiper/washer. A back-seat DVD entertainment system and a satellite navigation system are optional.


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The Joy of Violent Movement
Independent Music with an International Focus
Live Footage, metal, New Video, Psych Rock, thrash metal, Video Video
by William Ruben Helms November 4, 201920:15 November 4, 2019
Live Footage: King Gizzard and the Lizard Wizard on Live on KEXP
The genre-defying Aussie psych rock act and JOVM mainstays King Gizzard and the Lizard Wizard released five albums in a wildly prolific burst in 2017 — with each album managing to be in a completely different genre and style. Naturally, such a feat helped to cement the band's reputation for being restlessly prolific and experimental. So for a band known for being like clockwork when it comes to releasing new material, last year's lack of new material sticks out as anomaly. However, in fairness to the members of the band, they spent part of last year on a busy world tour that featured a headlining set at Desert Daze and three-sold out nights at Brooklyn Steel, one of the larger venues they had played at the time in the States — until their Rumsey Playfield show with Stonefield and Orb back in August.
This year finds the acclaimed and wildly prolific Aussie psych rock at speeding up the pace. Earlier this year, they released the boogie blues-tinged Fishing for Fishes and in August, they released their second album of the year and their 15th album overall, Infest the Rats' Nest. Now, as you may recall, Infest the Rats Nest featured what may arguably be the most pared down lineup of their entire creative output: the band's creative mastermind Stu McKenzie (vocals, guitar, bass), Joey Walker (guitar, bass), and Michael Cavanaugh (drums) with the band's remaining members busy with prior commitments. The reduced lineup allowed the band to focus on crafting together arrangements with a pummeling and feral ferocity inspired by McKenzie's long-held love of thrash metal — in particular, Metallica, Black Sabbath, and Rammstein.
King Gizzard's 15th album, sonically and thematically is a radical and unexpected departure from its most immediate predecessor: the album's material may arguably be the darkest and bleakest efforts they've released to date, as the band seethes with disgust and contempt over the human race's myopia, stupidity and greed. At its core, is the acknowledgement that we're all blindly marching lockstep to our annihilation — and maybe we deserve it.
During the band's last North American tour, they stopped by KEXP to record a live session, which featured material off Infest the Rats Nest that included the Black Sabbath-like "Mars for the Rich," the pummeling Slayer-like "Venusian 1," "Venusian 2," and "Hell" and the Ride the Lighting-era Metallica-like "Perihelion." The live footage is not just a taste of their amazing live show, it's a reminder that King Gizzard may be one of the best indie bands in the world — their dexterous musicianship allows the band the versatility to play anything with a self-assuredness and pitch-perfect accuracy.
Tagged with: Black Sabbath Brooklyn Steel Desert Daze KEXP King Gizzard and the Lizard Wizard King Gizzard and The Lizard Wizard Infest The Rats' Nest Live Footage Live Footage: King Gizzard and the Lizard Wizard on Live on KEXP metal Metallica Metallica Ride the Lightning New Video psych rock Rammstein Summerstage Rumsey Playfield The Joy of Violent Movement: Live Footage: King Gizzard and the Lizard Wizard on Live on KEXP thrash metal video
William Ruben Helms
I'm a music blogger, critic and photographer, who has had articles and photos published in Downbeat, Premier Guitar Magazine, Brooklyn Magazine, The New York Press, New York Magazine's Vulture Blog, Ins&Outs Magazine, The Noise Beneath the Apple, Glide Magazine, The Whiskey Dregs Magazine and others.
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text:
USS Ford Will Set Sail With Only 2 Out of 11 Weapon Elevators
After years of work, the ship still isn't 100 percent fixed.
By Kyle Mizokami
.S. Navy photo by Mass Communication Specialist Seaman Apprentice Angel Thuy Jaskuloski
The USS Ford is the first ship with electromagnetically powered elevators designed to lift bombs and missiles between decks.
After years of work only two of the elevators still work.
The Secretary of the Navy originally promised that President Trump could fire him if the elevators don't work on delivery but has now declared the ship "ready to go".
The USS Gerald R. Ford will sail from the shipyard this month where she was built to a Navy shipyard, marking a major milestone in her progression into U.S. Navy service. One thing that won't be ready on the ship, are nine of the eleven electromagnetically powered elevators that carry munitions from the ship's magazine to the hangar. The Secretary of the Navy claims he told President Trump to fire him if the elevators weren't fully operational by the time the ship is delivered to the sea service.
The USS Ford is the first of a new class of nuclear powered aircraft carriers. One of several new features onboard the ship are her eleven Advanced Weapon Elevators, or AWEs. Weapons elevators lift bombs, missiles, and other munitions from the magazine below to aircraft waiting in the hangar. Older elevators are hydraulically powered and can lift 10,500 pounds of munitions at 100 feet per minute. The AWEs, by comparison, can lift 20,000 pounds of munitions at a rate of 150 feet per minute. That's a pretty significant leap in capability.
The AWEs use electromagnetic propulsion to lift, similar in principle to the Electromagnetic Aircraft Launch System (EMALS) catapults that fling aircraft off the flight deck. EMALS is apparently fixed but AWE is not.
Two of the working Advanced Weapon Elevators.
U.S. Navy photo by Mass Communication Specialist Seaman Zachary Melvin
A Navy public affairs officer quoted by U.S. Naval Institute News seems to indicate that the elevators were built for the first time aboard the carrier while being developed, a manufacturing process known as concurrency.
"Due to the concurrent nature of development and construction, the shipboard AWEs have been test beds for identifying many of the remaining developmental and production issues for this first-in-class system, including issues with producing the tight tolerances required for the impacted doors and hatches," Hernandez told USNI News. The Navy is continuing to troubleshoot the problem, building a "land-based test site" and a software twin to fix it.
In March, the Navy delayed the delivery of Ford from July to October in order to get the elevators working. Ford was already two years late and several billion over budget.
The failure to fix the elevators is a problem for the carrier, which is scheduled to undertake its first cruise in 2021. It's also a problem for Secretary of the Navy Richard Spencer, who promised President Trump he could fire him if the Navy could not fix the AWEs before delivery. According to USNI News, Spencer discussed the issue with Trump and said:
"I asked him to stick his hand out; he stuck his hand out. I said, let's do this like corporate America. I shook his hand and said, the elevators will be ready to go when she pulls out or you can fire me."
In a new statement the Secretary of the Navy made no reference to the elevator problem or his offer to be fired if they can't be fixed, stating that the "crew and ship are ready to go to sea."
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