Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 259

Posts Tagged ‘clinical trial’

Reprieve Cardiovascular Announces Late-Breaking Acute Heart Failure Clinical Trial Data

Posted by fidest press agency su lunedì, 27 maggio 2019

Reprieve Cardiovascular™, a pioneering medical device company focused on improving outcomes for patients suffering from Acute Decompensated Heart Failure (ADHF), today announced the results of two non-randomized, prospective clinical trials in patients hospitalized with Acute Heart Failure (AHF). The two studies demonstrate that using Reprieve-Guided Diuretic Therapy, the first fully automated fluid management system, allows for safe decongestion for patients with AHF. The results were presented today at the Heart Failure 2019 Congress, 25-28 May, in Athens, Greece.The 19-patient TARGET-1 and TARGET-2 clinical trials were designed to determine whether the Reprieve-Guided Diuretic Therapy system could achieve safe net volume reduction while significantly alleviating related symptoms in ADHF patientsThe data reported a significant increase in diuresis, net negative fluid balance, improved kidney function and improvement in clinical symptoms.Patients served as their own controls with each patient undergoing 24 hours of standard diuretic therapy with intravenous furosemide followed by 24 hours of diuresis with the automated Reprieve-Guided System. The average urine output increased from 1986 ml in the standard therapy to 6284 ml during a 24-hour therapy period. In addition, there were improvements in net fluid loss, and renal function accompanied by favorable hemodynamic changes.“The therapy appears to be safe and quite effective,” said Professor Piotr Ponikowski, Professor of Cardiology at Wroclaw Medical University, Poland. “Reprieve’s automated fluid management technology provided faster, more controlled fluid removal while protecting acute heart failure patients from dangerous drops in blood pressure. It maintained optimal intravascular fluid volume and with it, cardiac output and renal perfusion.” ADHF is a sudden onset of heart failure symptoms, which typically include difficulty breathing (dyspnea), swelling in the extremities, and fatigue. The signs and symptoms of fluid overload are responsible for 90% of heart failure hospital admissions. Current treatment for ADHF includes diuretic therapy that aims to restore healthy fluid levels in the kidneys and throughout the body. Standard diuretic therapy, however, can be unpredictable and lose effectiveness as a patient’s condition deteriorates. In some patients, diuretics can trigger a condition called “diuretic resistance,” which blunts the function of diuretics and can exacerbate the severity of fluid overload, potentially resulting in acute kidney injury.

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Augmenix Announces Positive Clinical Trial Results Demonstrating Efficacy of SpaceOAR

Posted by fidest press agency su venerdì, 29 settembre 2017

prostateResearchers have long known that higher radiation doses (dose escalation) are more effective at killing tumors. However, the amount of radiation safely delivered to the prostate is limited by the rectum proximity, and concerns of creating long-term rectal injury and associated side effects. Physicians at the University of Texas Southwestern Medical Center and Memorial Sloan Kettering Cancer Center recently evaluated 44 men receiving SpaceOAR Hydrogel followed by dose-escalated (45 Gray) SBRT. The data show that SpaceOAR Hydrogel significantly reduces rectal injury in men undergoing high-dose SBRT for prostate cancer. Specifically, 13.6 percent of treated men had rectal mucosal injury in the study, all of which were mildly symptomatic and completely healed within six months following treatment. These findings are significant, as prior clinical research found that 90 percent of non-SpaceOAR Hydrogel patients treated with the same SBRT regimen experienced similar radiation-induced mucosal injury due to higher rectal wall radiation doses. None of the patients exhibited signs of biochemical cancer recurrence in the 12-month follow up period.“Hypofractionated approaches are gaining momentum in the treatment of prostate cancer, and in our experience, high-dose regimens have provided exceptionally high rates of biochemical control, but at the cost of an increased risk of rectal complications associated with the rectal wall dose,” said Michael Folkert, MD, radiation oncologist and brachytherapy specialist at University of Texas Southwestern Medical Center in Dallas. “Our new study demonstrates that use of the perirectal hydrogel spacer gets us the ‘room’ we need to safely deliver the most potent therapeutic doses to patients, which may ultimately lead to the optimal cancer control while significantly reducing the risk of treatment related complications.” As the first and only prostate cancer spacing device to receive Food and Drug Administration (FDA) clearance, SpaceOAR Hydrogel is placed between the prostate and rectum, protecting the rectum and surrounding tissue from high-dose radiation exposure. Long-term clinical data has shown that at both three and five years post-radiation therapy (using Intensity Modulated Radiation Therapy), patients treated with SpaceOAR Hydrogel demonstrated significant bowel, urinary and sexual function benefits.1-3
“We are excited by the successful results from this study, as it is the first time we’ve evaluated SpaceOAR Hydrogel in prostate cancer patients treated with high-dose SBRT, and the findings confirm a significant clinical benefit,” said John Pedersen, CEO, Augmenix. “As this robust data indicates – along with the other positive data on our hydrogel spacing technology presented this week at ASTRO – we remain steadfast in our vision to develop disruptive medical technology that improves the lives of patients receiving radiation therapy.”Prior SpaceOAR Hydrogel clinical studies have demonstrated significant reductions in long-term radiation side effects, and improvements in patient quality of life following the delivery of standard prostate radiation doses. This recent study was designed to see if SpaceOAR Hydrogel allows for safe prostate dose escalation, which if proven safe in other studies, has the potential to reduce cancer recurrence rates following prostate radiotherapy.For more information on SpaceOAR Hydrogel, visit (photo: prostate)

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Awarded at BioPharma Asia Industry Awards 2013

Posted by fidest press agency su martedì, 26 marzo 2013

Raleigh, North Carolina, March 25, 2013 /PRNewswire/ — PRA, a leading clinical research organization, today announced it was voted “Best CRO” for the 3rd annual BioPharma Asia Industry Awards 2013. The winner was announced March 19 at an awards dinner in Singapore.
Organized by Terrapinn, the awards honor and generate public recognition of the efforts, accomplishments and positive contributions of organizations and individuals in Asia’s biopharmaceutical industry. They identify and reward those who demonstrate an ability to succeed, continually set standards of excellence, and who will be the future of the biopharmaceutical industry. There are nine award categories: Best LSP Award; Best Contract Research Organization Award; Best Contract Manufacturing Organization Award; Most Innovative Asian Biotech Award; Asian Executive of the Year; Woman Executive of the Year; Best Manufacturing Solution Provider Award; Best Drug Pipeline Award; and Pharma Company of the Year.
PRA is transforming clinical trials through our people, innovation and transparency. PRA provides personalized service customized to the unique requirements of each study. We support our global reach and innovative approach through flexible and reliable service, delivered by skilled employees dedicated to ensuring that sponsors achieve their long-term goals. We serve our clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge. Offering services in 80+ countries and serving sponsors for 35+ years, we have amassed a level of expertise that has enabled us to work on a variety of compounds, ranging from niche treatments and therapies to blockbuster drugs. But at PRA, we are looking to the future, not the past. Our increasingly forward-thinking approach to transforming the clinical trial landscape will continue to make a difference to healthcare patients around the world.

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Chiltern Wins CRO Leadership Award From Life Science Leader

Posted by fidest press agency su martedì, 22 maggio 2012

London, (PRNewswire) Chiltern International Limited (Chiltern), a global contract research organization (CRO), announced that Chiltern has been recognized with a CRO Leadership Award in all five categories: Quality, Reliability, Accessibility, Productivity and Regulatory. The awards are given by Life Science Leader publication based on the data-driven research of Nice Insight. Glenn Kerkhof, Chiltern CEO, stated, “Chiltern is delighted to be recognized as a CRO leader in the Quality, Reliability, Accessibility, Productivity and Regulatory categories. Chiltern has been serving clients with pride for 30 years and has established a track record around the world as an expert, efficient and highly responsive full service CRO. It is a privilege to be recognized by members of the pharmaceutical industry that we serve and a great pleasure to accept this award on behalf of all of the people at Chiltern.”
Established in 1982, Chiltern is a leading global clinical CRO with extensive experience in the management of Phase I-IV clinical trials across a broad range of therapeutic areas, functional service provision and contract staffing solutions. Chiltern has conducted trials in more than 40 countries, employs nearly 1,300 people globally and offers services in Early Phase, Global Clinical Development, Late Phase, Biometrics, Medical and Regulatory Affairs and Resourcing Solutions. Chiltern prides itself as a development partner that offers flexibility, responsiveness and quality delivery.

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Australian Discovered Biomarkers Map Path to New Blood Test for Bowel Cancer

Posted by fidest press agency su lunedì, 21 maggio 2012

San Diego, (PRNewswire)A team of Australian scientists has identified new genes that show identifiable changes in the blood of people with bowel cancer. The discovery has the potential to underpin a new cost-effective blood test that would signal the early stages of bowel cancer. This test could potentially save thousands of lives by supplementing existing screening programs and encouraging those at risk to have a colonoscopy. The research[1] – presented earlier today for the first time at a major medical conference in the United States – is the result of over five years of scientific collaboration between Australian biotechnology company Clinical Genomics, CSIRO and the Flinders Centre for Innovation in Cancer at Flinders University in Adelaide, lead by senior investigator Professor Graeme Young.A new blood test for bowel cancer based on these discoveries is now under development and is currently being tested with patients from Australia, the United States and Europe. The Australian research team is hoping to attract interest from other clinicians and scientists around the world to help them further validate the new test. Dr Lawrence LaPointe, CEO of Clinical Genomics, said they have shown a high detection rate for bowel cancer while also demonstrating a false positive rate of about 5% in samples drawn from a high-risk population. These clinical trial results are highly promising but we need to go one step at a time. The next step is to seek help from other groups and researchers to cast the net more broadly to see what we can achieve with a larger number of tests drawn from a sample of the general population,” Dr LaPointe said. “There is still some time to go before a blood based test of this nature might be broadly available to a community but the technology is clearly worthy of broader, rigorous testing. Importantly, a simple blood test like this could significantly improve patient participation with bowel cancer screening programs,” Dr LaPointe said.

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Cromsource Adds Early Phase Research Unit to its Portfolio

Posted by fidest press agency su martedì, 14 febbraio 2012

Verona, Italy (PRNewswire) Cromsource srl, an international full service contract research organisation (CRO) today announced the completion of an innovative private-public deal with Centro Ricerche Cliniche di Verona (CRC), a modern early phase clinical research unit, founded in 2005. The CRC is located in Verona and is now under state and CROMSOURCE ownership. The early phase clinical research facilities of the CRC occupy about 800 square metres of the 8th floor of the G.B. Rossi Hospital in Verona. The CRC provides full overnight accommodation and is equipped to state-of-the-art levels. Staff at the CRC has extensive international Pharma experience and the CRC is fully integrated within the local medical and scientific community. This provides access to highly motivated, well-defined patient populations and disease groups for Proof-of-Concept studies. Dr Caffi, Chairman, Integrated University Hospitals of Verona, said ‘our commitment to promoting international scientific research is further strengthened through this agreement with CROMSOURCE. Our full range of hospital services and facilities has always been available to CRC and we look forward to providing the same level of support to CROMSOURCE.’
Dr Stefano Milleri, Scientific Director of CRC noted ‘for many years CRC has been proud to utilise our expertise and facilities to support the development of medicines on behalf of our clients. CROMSOURCE have a similar history and we share a philosophy of quality, flexibility and intense customer focus. We are therefore very excited to be joining the CROMSOURCE family.’
About CROMSOURCE: CROMSOURCE is an ISO certified, full-service Contract Research Organization providing clinical trial services and staffing solutions since 1994. CROMSOURCE delivers clinical trials across Europe, Russia, Ukraine and the USA. CROMSOURCE provides One Trial One Price – a fixed price guarantee which assures clients that each project will be delivered according to the contract price.

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Marketsand Markets: Global Clinical Trial Management Systems Market Worth $1300.4 Million by 2016

Posted by fidest press agency su martedì, 24 gennaio 2012

Dallas.The report “Clinical Trial Management Systems (CTMS) Market: Global Trends, Opportunities, Challenge and Forecasts (2011 – 2016)”, as the name suggests, analyzes and studies the major market drivers, restraints, and opportunities in North America (U.S. and Canada), Europe, Asia, and Rest of the World.Browse market data tables and in-depth TOC on Clinical trial management system market.http://www.marketsand Market-Reports/clinical-trial-management-systems-market-470.htmlEarly buyers will receive 10% customization on reports.Clinical trial is a medical research study that is performed in humans to check the safety and efficacy of drugs, devices, and therapeutic products before they are launched into the market for patient use. Clinical trials are very crucial as they involve huge capital investment and may affect the subjects involved. Thus proper management of clinical trials has become a priority for the hospitals.Clinical Trial Management System caters these needs of clinical trial players as CTMS is employed to manage the large amounts of data involved in a clinical trial. It maintains the planning, preparation, performance, and reporting of clinical trials, including participant information, trial and filing deadlines and other important milestones. The global CTMS market is estimated to grow at a CAGR of 14.53% during the study period (2011-2016).In this report, the global CTMS market is studied by the end-users, delivery mode, components, and types through various geographies. North America is leading the global CTMS market with around 62% share in 2010, as majority of the global clinical trials are conducted in North America, especially in the U.S. (around 58.5% share).The U.S. is the largest market, and shows a remarkable growth opportunity. The second largest market, Europe, while growth in the Asia-Pacific region is also expected to take greater curves in the near future.Major players in the Clinical Trial Management Systems Market [ ] include Oracle Corporation (U.S.), Perceptive Informatics (a subsidiary of Parexel International Corporation) (U.S.), Medidata Solutions (U.S.), eResearch Technology Inc. (U.S.), and BioClinica Inc. (U.S.).
MarketsandMarkets is a global market research and consulting company based in the U.S. We publish strategically analyzed market research reports and serve as a business intelligence partner to Fortune 500 companies across the world.

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Bambino Gesù: Sperimentazioni in età evolutiva

Posted by fidest press agency su sabato, 10 aprile 2010

Prende il via all’Ospedale Pediatrico Bambino Gesù di Roma l’attività del Clinical Trial Center, struttura creata all’interno del nuovo Dipartimento di Pediatria Universitario-Ospedaliero, che conta su un team medico e infermieristico dedicato e specializzato nelle procedure cliniche e nelle metodologie necessarie per eseguire sperimentazioni farmacologiche in età evolutiva. L’iniziativa anticipa le decisioni istituzionali in merito al “Regolamento pediatrico” per la sperimentazione dei farmaci in pediatria, superando le lacune della sperimentazione sulle indicazioni cliniche, per i dosaggi e per le formulazioni dei medicinali al fine di garantire l’adeguatezza delle cure rivolte ai piccoli pazienti. Nel corso del 2010, fase iniziale e pilota dell’attività del Centro, si prevede che saranno condotte a vario titolo circa 40 sperimentazioni. Già in corso quella relativa al primo vaccino terapeutico al mondo per bambini infetti da HIV. (fonte farmacista33)

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