CPR Data Debriefing by Hospital Responders Improves CPR Performance and Increases Initial Survival Rate Following Cardiac Arrest
... Philips HeartStart MRx with
Q-CPR Measurement and
feedback was used to record resuscitation ... leaders in hospitals to use valuable
feedback from
actual cardiac arrest cases to supplement ... participants who received post-resuscitation
feedback compared to a
control group of professionals who ...
Cardium's Innercool Therapies Unit Announces Publication of Positive Effects of Early and Rapid Hypothermia Following Heart Attack
... temperature sensor enables fast and precise
feedback of
core body temperature, compared to delayed temperature
feedback using
peripheral temperature probes. Speed and ... control element and a built-in
temperature
feedback sensor to provide fast and precise patient ...
Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease
... series of discussions with the European Medicines Agency (EMEA). Based on
feedback from the EMEA, the Companies expect a separate clinical study will be ... statistics.
Amicus and Shire HGT are reviewing the final EMEA
feedback and will provide an update regarding plans for registration in Europe in ...
DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD
... company, announced today that it has received Protocol Assistance
feedback from the European Medicines Agency (EMEA) on the design of its ... design features of the new study. The EMEA's response is consistent with
feedback previously received from United States Food and Drug Administration (FDA), ...
Study Results Reveal alli(R) Patient Satisfaction Linked to Weight Loss Achieved; Not Treatment Effects
... treatment effects were viewed by many alli users as a
positive
feedback tool that helps them become more aware of hidden fats in
foods. Many ... director, Medical Affairs,
GlaxoSmithKline Consumer Healthcare. Consumer
feedback In addition to the cumulative data analysis released at NAASO, ...
New Research Shows: Neurofeedback is an 'Evidence-Based' Treatment for ADHD
... regarded as an evidence-based treatment for Attention Deficit- /
Hyperactivity Disorder (ADHD).
Neurofeedback is a treatment where real-time
feedback is provided for
specific brain activity (most often EEG) in order to learn the brain to
suppress or produce specific brain activity. This method was ...
Great Basin Scientific, Inc. Raises $3.6 Million in Bridge Funding to Prepare for Launch of First Product
... beta-testing sites for Great Basin Scientific's point of care molecular platform. During beta-testing, clinicians will test the analyzers and provide
feedback on process flow and functionality. The testing will serve as preparation for the clinical trials scheduled to begin in August.
Future tests ...
VA Studies Advanced Prosthetic Arm
... arm.
The study is under the direction of Dr. Linda Resnik at the Providence, R.I., VA Medical Center. Veterans fitted with the arm will provide
feedback to guide engineers in refining the prototype, before it is commercialized and also made available through the VA health care system.
A unique ...
Terumo Heart, Inc. Reaches Clinical Milestone as the 100th Patient Worldwide Receives the DuraHeart(TM) Left Ventricular Assist System
... to its benefit and the commitment and belief of cardiothoracic surgeons in Europe and the U.S. in its potential. We continue to receive excellent
feedback from physicians and are working toward completion of enrollment and ultimately commercial use of the DuraHeart LVAS in the US."
For more ...
Anthera's Varespladib Meets Primary Endpoint in Phase 2 FRANCIS Trial for the Treatment of Acute Coronary Syndrome
... cardiovascular studies, varespladib has been generally well tolerated.
About the FRANCIS trial
The FRANCIS trial is based upon direct
feedback from Food and Drug Administration via the Special Protocol Assessment process. FRANCIS was designed to assess the impact of oral varespladib on known ...
USAID Cooperates in Pandemic Preparedness Initiative
... A review session will be conducted after the exercise in East Africa to allow participants the opportunity to reflect on lessons learned and provide
feedback on strengthening pandemic preparedness. Following the review, a report will be drafted and will serve as a reference to facilitate the development ...
FDA Advisory Committee Recommends Approval of Multaq(R) (dronedarone)
... of today's discussions and positive recommendation," said Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis. " The panel's insightful
feedback which concluded with a positive vote, is an important step in gaining FDA approval of Multaq ."
The FDA is not bound by the Committee's ...
Forest Laboratories, Inc. and Laboratorios Almirall, S.A. Provide an Update on the Aclidinium Bromide Clinical Development Program
... to patients using a novel, state-of-the-art multidose dry powder inhaler (MDPI), Genuair(R)(2). Genuair(R) was designed with an intuitive
feedback system, which through a 'colored control window' and an audible click indicates that the patient has inhaled correctly. The Genuair(R) inhaler ...
From eResearchTechnology to ERT
... its new branding. Formerly eResearchTechnology, Inc., the company has adopted an entirely new image and character for the company following staff
feedback and customer affirmation of its core values. The unrivalled business found that both customers and employees expect and receive a commitment from ERT ...
10-State Project to Study Methods to Reduce Central Line-Associated Bloodstream Infections in Hospital ICUs
... compliance with safety practices, educate staff on evidence-based practices to reduce bloodstream infections, educate staff on team training, provide
feedback on infection rates to hospitals and hospital units, and implement monthly team meetings to assess progress.
This project is funded through ...
Good Medicine: Smarter Smartphones for People With Chronic Disease
... smart labels have small electronic chips in
them containing data about the medication being taken. The phone reads the
data on the chip and provides
feedback about the medicine.
The system can send alerts to caregivers if a medication is missed. "If
your father forgot his blood pressure medicine ...
Osteotech Initiates Pivotal Clinical Trial for DuraTech(TM) BioRegeneration Matrix
... reduce the potential for immune reactions," added Mohammed Attawia, M.D., Osteotech's Vice President of Product Development. "Additionally, surgeon
feedback during these preclinical trials indicate that DuraTech is easier to handle and provides greater flexibility during surgery than competitive ...
Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback
... material made in
Alkermes' manufacturing facility, and commercial-scale drug product made at
Amylin's manufacturing facility.
"Following
feedback from FDA, we now have an appropriate pathway to
demonstrate manufacturing comparability of exenatide once weekly. This is a
very important step for ...
Vascular Surgeons Agree: Case Rehearsal Improves Outcomes
... excellent: surgeons "strongly
agreed" that the simulator was easy to use, realistically replicated
reality, produced realistic imaging and tactile
feedback (haptics),
realistically replicated patient arch, carotid and lesion anatomy and that
it accurately predicted stent dimensions. All simulated EPD, ...
BioMarin Announces Positive Results From Phase 2A Clinical Study of 6R-BH4 in Sickle Cell Disease
... -- Improvement in endothelial dysfunction appeared to be dose-dependent. -- 6R-BH4 was well-tolerated in sickle cell disease patients.
Pending
feedback from the FDA at a pre-IND meeting in November, future
development plans could include a cross-sectional study in sickle cell
disease patients to ...
First Town Hall Meeting on Inequities in Clinical Trials to Take Place at the Harlem Hospital Center on October 20
... clinical trials
navigation is not currently an accepted standard of practice for
institutions conducting human research studies, which is why
feedback from
community leaders on ways to deliver participant navigation services is
needed to increase the use of this important tool.
At the same time, ...
Say 'Goodbye' to Back Fat Rolls
... found minimal complications and about two weeks after
surgery, patients were allowed to increase their activity levels based on
their discomfort.
feedback from all seven patients was uniformly positive,
according to the study.
The study concluded that the procedure is a safe and powerful method ...
Anesiva Accelerates Its Transition to Specialty Pharma Pain Management Company
... the range of $2.0 million to
$3.0 million. The sales force has had early successes in obtaining
formulary acceptances. This, combined with positive
feedback from early
market experience, suggests Zingo is well-positioned for accelerated sales.
-- The transition to fully automated Zingo manufacturing is ...
Phase III Clinical Studies of Aclidinium Bromide Show Statistical Significance vs. Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)
... administered to patients using a novel,
state-of-the-art multidose dry powder inhaler (MDPI), Genuair(R).
Genuair(R) was designed with an intuitive
feedback system, which through a
'coloured control window', an audible click and a slightly sweet taste
indicates that the patient has inhaled correctly. The ...
Wound Management Technologies, Inc. Announces Agreement for Evidence Based Study for Diabetic Venous Ulcers
... 2 million working days and incur treatment costs of
approximately $3 billion per year in the United States.(1) "We have had
very positive
feedback from clinicians using CellerateRx(R) on these types
of wounds. We look forward to providing this data to the medical
community," Bradshaw said.
(1) ...
eRT Announces the Availability of the Suicidality Monitoring System(TM) For Clinical Trials
... and complete presentation of every question;
electronic recording of respondents' answers; documentation of the
assessment completion; and prompt
feedback and reporting to the study
sites. Patients are more likely to disclose sensitive subject matter,
including suicidality, in computer interviews than ...
HUYA Bioscience Int'l Announces Pre-IND Outcome for HBI-3000 - Promising Anti-Arrhythmia Compound Sourced From China
... FDA
feedback Supports Innovative Co-development Model
SAN DIEGO, June 17 /PRNewswire/ -- Bio International Convention 2008
( http://www.bio2008.org ) -- HUYA ...
Repligen Announces Plans to Initiate a Phase 2b Trial for RG2417 in Bipolar Disorder
... from Positive Phase 2a Trial
WALTHAM, Mass., June 12 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN ) today announced that based on
feedback from the Food and
Drug Administration, the Company plans to initiate a Phase 2b clinical
trial of RG2417, an oral formulation of uridine, in patients ...
Discovering How Video Games Can Motivate Healthy Behaviors: More than $2 Million Awarded to 12 Research Teams Across U.S.
... aged 50+. The system combines a stationery bicycle with
FitClub cardiovascular exergame software, which uses a touch screen to
provide individualized
feedback to the player and a three-dimensional
virtual environment for exercise that can be shared with other players
competitively or collaboratively.
...
Quigley Announces Successful Poultry Study of Chickens With Infectious Bronchitis; Plans to Approach the Poultry Industry for Potential Commercialization
... mortality,
clean-up costs and disruption to operations.
The Company initiated its investigations into the effectiveness of this
compound based on
feedback from poultry industry leaders who expressed an
increasing need for additional products to combat Infectious Bronchitis
(IBV).
Dr Richard ...
HUYA Bioscience Int'l Announces First Pre-IND Outcome for a Development Stage Compound Sourced From China - HBI-8000, Promising New Cancer Compound
... FDA
feedback validates HUYA's Integrated Co-Development Model for China-sourced Drug Candidates
SAN DIEGO, April 14 /PRNewswire/ -- HUYA ...
Synbiotics Corporation Announces Human Submission for FluDetect(R)
... both in humans and animals and can be a vital tool to
healthcare institutions for both seasonal flu testing as well as in endemic
situations.
"The
feedback we have received on the outstanding field performance of
FluDetect(R) in avian influenza has encouraged us to seek human use," said
Paul Hays, ...
EDICT Opens Public Comment Period for Clinical Trials Policy Recommendations
... Online
feedback platform will remain open until March 21, 2008
HOUSTON, March 3 /PRNewswire-USNewswire/ -- Using the same process as
government agencies when ...
IDM Pharma Announces Non-Binding Opinion of the European Committee for Medicinal Products for Human Use (CHMP) that Mifamurtide (L-MTP-PE) Provides a Possible Clinical Benefit in Survival
... to receive a final opinion from
the CHMP in the third quarter and a final decision from the European
Commission in the fourth quarter of 2008.
"The
feedback from the CHMP regarding the positive survival benefit
offered by L-MTP-PE, while not binding, provides the Company a pathway to a
potential positive ...
Indevus Reports Additional Positive Phase III Trial Data for NEBIDO(R)
... with the optimal long-term
dosing solution for treating their male patients with hypogonadism.
Importantly, we are extremely pleased with the
feedback we recently
received from the FDA that the PDUFA target action date was likely to
remain unchanged."
Study Design
The most recent Phase III ...
MJFF and Merck Serono (EMD Serono in North America) Join Forces on $2-Million Initiative to Drive Treatments for PD-Related Cognitive Dysfunction and Mood Disorders
... Cognitive dysfunction, which includes difficulty in planning,
sequencing, initiating and sustaining behavior toward a given goal, and
incorporating
feedback to make adjustments along the way, is estimated to
occur in up to 80 percent of people with PD. Depression is thought to
affect up to 50 percent of ...
Pharsight Uses FDA Disease Model to Support Oncology Drug Development
... and covering critical issues in trial design, dose selection, and
development strategy. We look forward to collaborating with our client to
share
feedback with FDA, and to contributing to ongoing industry
discussions on opportunities for sharing drug-disease models to support
quantitative ...
Progen Presents Additional Analysis of Data from PI-88 Phase 2 Liver Cancer Study at American Association for the Study of Liver Diseases
... endpoint of disease-free rate at 48 weeks
and 78% improvement in secondary endpoint of disease-free survival. These
results, combined with positive
feedback from the FDA, provide Progen with
confidence in the potential of PI-88 for this indication and we are
therefore aggressively pursuing its development ...
International Expert Group Initiates Largest Multi-center Phase III Trial to Evaluate NeuroAid(TM) in Stroke Recovery
... NeuroAid(TM) has generated
in the medical community worldwide. Over 200,000 patients in China alone
are using NeuroAid(TM) every year, and patient
feedback from other
countries is very positive. Our next milestone is to generate clinical data
in the acute phase, with studies that meet the standards of ...
Velcura Therapeutics, Inc. Reports Positive Pre-IND Meeting With FDA and Plans Early Clinical Trials for New Drug to Treat Multiple Myeloma Bone Disease
... of VEL-0230, a drug developed to treat bone
disease. The focus of the Pre-Investigational New Drug Application (IND)
meeting was to obtain
feedback from the FDA's Division of Oncology Drug
Products about Velcura's completed preclinical studies, as well as
Velcura's near-term clinical development ...