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Labor Day 2014

1 September 2014. Today is Labor Day in the U.S. and Labour Day in Canada, thus Science & Enterprise will be taking a break. Regular posting resumes tomorrow.

Way before rap, there was talking blues. Here’s a recording of the late Pete Seeger with a talking blues song for Labor Day, Talking Union.

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Humanoid Robots Help Children with Autism Learn Interaction

Maja Mataric´ and robot

Maja Mataric´(University of Southern California)

29 August 2014. Engineers and computer scientists at University of Southern California in Los Angeles show how commercial humanoid robots can help children with autism spectrum disorder learn basic social behavior. The team from the lab of Maja Mataric´, director of USC’s Robotics and Autonomous Systems Center, presented its findings earlier this week at the IEEE International Symposium on Robot and Human Interactive Communication in Edinburgh, Scotland.

Autism spectrum disorder is a collection of neurodevelopmental conditions, marked by communication difficulties and impaired social interaction, as well as repetitive and stereotyped patterns of behavior. At age 8, some 1 in 88 children have autism spectrum disorder, according to Centers for Disease Control and Prevention. Classic autism is considered the most severe form of the syndrome.

The study devised by Mataric´ and colleagues aimed to find out how children with autism spectrum disorder react to humanoid robots that provide graded cueing, a process shaping behavior that uses increasing specific prompts to improve everyday skills of people in recuperative therapy. Graded cueing is employed for conditions such as brain injury, or to learn new or lost skills, as in the case of children with autism spectrum disorder.

For this pilot study, the USC researchers enrolled 12 children with autism spectrum disorder, who played an imitation game, a form of copycat, with a humanoid robot, the Nao model made by Aldebaran Robotics. The game asked the children to imitate 25 different arm poses.

Children performing the pose correctly received positive feedback from the robot in the form of flashing green eyes, or a nod and the spoken words “good job” in response. Half of the group received graded cueing feedback from the robot partner when the child did not accurately perform the pose. The prompts first began as verbal cues, followed first by more detailed instructions and then demonstrations. For the children in the other (control) group, the robots only repeated the command.

The results show children receiving the graded cueing feedback until the correct pose was performed improve or maintain their performance, while those receiving only a repetition of the command show no improvement or regress. The findings suggest receiving the varied feedback from a socially assistive robot can help children with autism spectrum disorder learn simple interactive skills.

The pilot study is one of a number of projects underway in USC’s Interaction Lab developing adaptive or personalized socially assistive robots to help people with special needs. “There is a vast health care need,” says Mataric´in a university statement, “that can be aided by intelligent machines capable of helping people of all ages to be less lonely, to do rehabilitative exercises, and to learn social behaviors.”

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Ebola Vaccine Safety Trials Scheduled in U.S., U.K., Africa

Ebola health care workers

Ebola health care workers in Guinea (European Commission-ECHO/USAID)

28 August 2014. Early-stage clinical trials testing the safety of new vaccines to protect against the Ebola virus are scheduled to begin as early as next week at sites in the U.S., United Kingdom, Mali, and The Gambia in West Africa. The vaccines are being developed by National Institute of Allergy and Infectious Diseases (NIAID), part of National Institutes of Health in the U.S., and the pharmaceutical company GlaxoSmithKline in the U.K.

This year’s Ebola virus disease outbreak is one of the largest ever recorded and affects four countries in Africa: Guinea, Liberia, Sierra Leone, and Nigeria. The disease is caused by a virus spread through direct contact, often through broken skin or mucous membranes, with a sick person’s blood or bodily fluids, contaminated objects such as needles, and infected animals. Family and friends of people with Ebola and health care workers are among those most at risk, because of the higher probability of coming into contact with bodily fluids from a person with the disease.

Early symptoms of Ebola virus disease are fever, severe headache, muscle and abdominal pain, weakness, diarrhea, vomiting, and unexplained bruising or bleeding that quickly become more severe and often lead to death. The incubation period is 2 to 21 days. According to Centers for Disease Control and Prevention, more than 3,000 cases of Ebola are confirmed or suspected, resulting in 1,552 deaths. World Health Organization says the 47 percent survival rate of the current outbreak is higher than in previous Ebola outbreaks.

Two Ebola vaccines are being developed. One vaccine aims to protect against the Zaire strain of the virus, causing the current West Africa outbreak. The other vaccine is designed to protect against both the Zaire strain and a separate Sudan strain of Ebola.

The first clinical trials will test the vaccines with healthy adults, to reveal unforeseen side effects and to measure the immune response generated by the vaccine. The trial in the U.S. will test the vaccine developed by NIAID and GlaxoSmithKline developed for both Ebola strains. The parallel trial in the U.K., Mali, and the Gambia will test the vaccine covering only the Zaire strain. Later trials will test for the vaccine’s efficacy, in this case its ability to prevent the disease in a healthy individual.

The vaccine is made of tiny amount of Ebola genetic material designed to generate a single Ebola protein, which in turn provokes an immune response in the recipient, but not cause the recipient to contract the disease. NIAID and GlaxoSmithKline say preclinical studies conducted last year show the vaccine was able to protect against the Ebola virus in primates, while not causing adverse effects.

The trial in the U.S. will be conducted at National Institutes of Health. The U.K. study will be conducted by the Jenner Institute at University of Oxford, which will be followed by a trial in the Gambia. A parallel study in Mali will be conducted by University of Maryland and the Malian health ministry in Bamako, the capital city.

GlaxoSmithKline says funding for the trials will enable the company to manufacture some 10,000 additional doses of its vaccine while the trials are underway, should results show the vaccine is successful. The additional doses will be provided to World Health Organization for distribution in high-risk communities.

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Biotech, Universities to Test Hydrogel for Vocal Fold Scars

Singer with guitar

(A. Kotok)

28 August 2014. BioTime Inc., a biotechnology company in Alameida, California, is partnering with researchers at University of Wisconsin and Université catholique de Louvain in Belgium to test its hydrogels for treating vocal cord scarring, a voice problem that results from injury or disease. Financial terms of the collaboration were not disclosed.

Vocal folds are part of the larynx that vibrate as air passes through when speaking or singing, made of a soft outer tissue, with ligaments and muscle underneath. When the larynx is injured due to trauma or disease, fibrous scars replace the normal tissue in the vocal folds causing hoarseness, vocal fatigue, delays in producing voice, and impaired singing, particularly in upper ranges. Therapies for vocal fold scarring usually involve treatments for symptoms or surgery.

BioTime produces hydrogels, a matrix of biocompatible extracellular materials, as cultures for the growth and transformation of stem cells, but also as delivery mechanisms for therapies. Susan Thibeault is a medical researcher at University of Wisconsin that studies the use of hydrogels to help repair scarred vocal folds, particularly in the delivery of hyaluronic acid, a natural lubricating fluid in the body produced in the larynx.

In the partnership with BioTime, Thibeault and colleagues at Wisconsin will conduct lab research with BioTime’s line of hydrogels to find the optimum formulations that reduce scarring in vocal folds and restore the elasticity need to function properly. Based on Thibeault’s findings, Marc Remacle at Université catholique de Louvain will conduct early-stage clinical trials to test those formulations in human patients.

BioTime is already testing a product that delivers treatments to the face region. The company produces Renevia, a hydrogel product currently in clinical trials as a way to deliver adipose (fat) tissue for patients with lipoatrophy, a condition affecting people with HIV. Lipoatrophy is the wasting away of fat tissue in the face caused by antiretroviral drugs prescribed for HIV.

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Smartphone App Screens Infants for Jaundice

Bilicam baby photo

Newborn being photographed with BiliCam color-calibration card (University of Washington)

27 August 2014. Computer scientists and medical researchers at University of Washington in Seattle are developing a system that lets physicians or parents with a smartphone screen newborn infants for jaundice. The system is described in a paper to be presented on 16 September at the ACM International Joint Conference on Pervasive and Ubiquitous Computing (UbiComp 2014) in Seattle.

Jaundice is a common condition among newborns that results in a yellowish discoloration of the baby’s skin, from an excess of bilirubin, a pigment in the blood. Jaundice occurs in newborns when the liver is not sufficiently developed to rid the blood of bilirubin, a condition not considered immediately dangerous, but if left untreated could lead to severe jaundice or other complications.

The team from the Washington labs of computer scientist Shwetak Patel and pediatrician James Taylor designed the system, called BiliCam, to provide a quick and simple method to screen infants for jaundice. Testing for infant jaundice today requires either analyzing a blood sample for total serum bilirubin (TSB)  or a noninvasive transcutaneous bilirubinometer, a specialized measuring device used to screen for jaundice, where according to the authors, each test costs several thouand dollars.

BiliCam requires a photo be taken with a smartphone camera of the baby and a small color calibration card placed on the infant’s body. The image is first adjusted, if required, to account for lighting conditions, and then transmitted to a cloud-based analysis program. There, machine-learning algorithms perform the analysis and return a report to the sending smartphone within minutes.

The researchers tested BiliCam with 100 newborns at two sites in Seattle, 2 to 5 days after birth, where parents allowed their babies to be photographed and analyzed with BiliCam as well as be given the current TSB blood test. The results show a high correlation — o.85, where 1.00 is perfect 1-to-1 correlation — between the BiliCam and the TSB test. That level of correlation, say the authors, is similar to the correlation between TSB and the transcutaneous bilirubinometer used for screeening.

The researchers plan to expand testing to 1,000 newborns, including babies with darker skin pigments to make the system equally usable for all ethnic groups. The researchers filed for patents on the technology and expect to have a submission for approval within 2 years to the U.S. Food and Drug Administration .

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Ionic Liquids Shown to Combat Bacterial Biofilms

Pseudomonas aeruginosa bacteria (NIH)

Pseudomonas aeruginosa bacteria (NIH)

27 August 2014. Researchers at Los Alamos National Lab in New Mexico developed a way to harness ionic liquids — salts in a liquid state — that in lab tests disrupt biofilms, antibiotic-resistant bacterial colonies, and boost treatments for skin infections. The team led by Los Alamos Lab’s David Fox and Samir Mitragotri at University of California in Santa Barbara published their results appearing in yesterday’s issue of Proceedings of the National Academy of Sciences (paid subscription required).

Biofilms are communities of microbes that connect and expand through a matrix of organic matter. These microbe colonies also stick tightly to surfaces, including the skin, making them difficult to treat, because of their persistence and ability to resist conventional antibiotics. When biofilms cause skin infections, the bacteria are further protected by the outermost layer of the skin. The authors cite data showing biofilms are responsible for some 80 percent of bacterial infections in humans, including wounds in the skin such as those developed at surgical incisions.

Fox and Mitragotri, with colleagues from their institutions as well as Dixie State University in Utah and Northern Arizona University, synthesized and tested ionic liquids as treatments for skin infections caused by biofilms. Ionic liquids are salt materials that form a liquid state below the boiling point, 100 degrees C, and are often used in industry as solvents, electrolytes, and lubricants.

The team tested a range of synthesized ionic liquids for their ability to break up biofilms, yet still deliver antibiotics through multiple skin layers and not irritate a patient’s skin. For these tests, they build a model wound with multiple skin layers in the lab, and tested the ionic liquid candidates on biofilms of two common bacteria: Salmonella enterica and Pseudomonas aeruginosa found in skin infections, including those acquired in health care settings.

The tests also included the ability to deliver cefadroxil, an antibiotic to treat skin infections through the multiple skin layers in the model. In addition, ionic liquids were tested against household bleach, already known to disrupt biofilms.

The tests show choline-geranate as the optimal ionic liquid for battling biofilms. The researchers report choline-geranate at least as effective as bleach in killing of more than 95 percent of the bacteria after a 2-hour treatment. In addition, choline-geranate was able to increase delivery of cefadroxil through 16 skin layers in the model, and did not appear to cause skin irritation.

“If the bacterial biofilm can be disrupted, delivery of antibiotics is greatly enhanced, and any dispersed pathogens are generally restored to normal antibiotic susceptibility,” says Fox in a Los Alamos Lab statement. “These materials are able to penetrate through the skin and effectively carry antibiotics to the deepest layers.”

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Implant Developed to Measure Pressure Causing Glaucoma

Women's eye closeup (Photos8.com)

(Photos8.com)

26 August 2014. Biomedical engineers at Stanford University in California and Bar-Ilan University in Israel designed an implanted device for people with glaucoma to take frequent and accurate measures of high pressure inside their eyes, a factor closely associated with glaucoma. The team led by Stanford bioengineering professor Stephen Quake and Bar-Ilan ophthalmologist Yossi Mandel published its proof-of-concept findings this week in the journal Nature Medicine (paid subscription required).

Glaucoma is the name given to a collection of eye conditions that result in damage to the optic nerve that in advanced stages can lead to vision loss. In most cases of glaucoma, abnormally high intraocular pressure results in the optic nerve damage. According to statistics cited by Glaucoma Research Foundation, glaucoma affects some 2.2 million people in the U.S., accounting for 9 to 12 percent of all cases of blindness. Blindness from glaucoma is 6 to 8 times more common among people of African descent in the U.S. than Caucasians. It is also the second leading cause of blindness in the world, according to World Health Organization.

The device in development by the Stanford/Bar-Ilan team aims to offer people with glaucoma a convenient way of measuring intraocular pressure, which can provide clinicians with important data for prescribing treatments to reduce that pressure. Measuring intraocular pressure, however, is tricky since pressure readings can vary from over the course of a day and be affected by factors such as other medications, and even the individual’s posture.

The device developed by Quake, Mandel, and colleagues aims to make it possible for people with glaucoma to take their own measurements of pressure inside the eye, which in turn enables closer monitoring of this key factor. The authors cite a previous study showing close monitoring of pressure readings by people with glaucoma led to changes in treatments in up to 80 percent of those cases.

The device is primarily an ultra-fine microfluidic channel that allows fluid from the eye to enter on one end, with a tiny bulb of gas on the other end. Pressure inside the eye pushes the fluid through the channel against the force of the gas, with the length of the fluid in the channel serving as a gauge of pressure inside the eye.

The researchers designed the device to be implanted with an intraocular lens, a synthetic eye lens that replaces an individual’s natural lens to correct astigmatism or as part of cataract surgery. Once implanted, people with glaucoma could use their smartphone cameras or wearable devices — e.g., Google Glass — to take intraocular pressure readings. Tests with a U.S. Air Force vision test, say the authors, show no optical distortions.

Stanford University applied for a patent on the pressure-sensor technology. But the researchers want to reconfigure the device as a stand-alone implant, rather than rely on an intraocular lens.

“For me,” says Quake in a university statement, “the charm of this is the simplicity of the device.” Its simplicity, note the authors, should help make it ready for clinical trials in a few years.

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University Starts Computer Science/Brain Research Consortium

3-D brain wiring illustration

3-D brain wiring illustration (NIH)

26 August 2014. Carnegie Mellon University in Pittsburgh organized an international consortium of researchers to apply computer science techniques to the study of brain research and behavior. The collaboration, known as BrainHub, includes researchers from nearby University of Pittsburgh, as well as Sun Yat-sen University in Guangzhou, China, Indian Institute of Science in Bangalore, and Oxford University and the University of Warwick in the U.K.

BrainHub aims to apply computational tools to learn more about cognition and learning, as well as uncover new insights into brain disorders such as autism and Parkinson’s disease. The five year, $75 million project is funded by a combination of new and existing allocations from foundations, local and federal government, individual donors, institutional partners, and internal university sources.

The consortium plans to develop new methods for measuring and understanding the connections between brain functions and behavior. Most current techniques, says CMU, focus on single brain cells or small groups of cells. This initiative seeks to develop better devices for recording brain cell activity, as well as the tools to analyze that activity, to better understand the functioning of the entire brain, not just small parts. The project also plans to identify changes in brain cell activity and correlate those activities with corresponding behavioral changes.

Another BrainHub objective is development of new methods for training the brain to improve its performance or treat neurological conditions, taking advantage of CMU’s previous work in computer-based training to analyze the brain’s changes during the learning process. This part of the project also plans to better understand the brain’s plasticity for learning new skills, as well as treat traumatic brain injuries and depression.

In addition, BrainHub plans to develop new computation tools to better collect and analyze the growing body of data in neuroscience and human behavior, in effect applying tools of “big data” to the field. The university says one of the obstacles facing researchers is the lack of large scale data sets describing brain functions, structure, and properties of brain cells, as well as their responses in humans or animals. The researchers hope to devise better techniques to integrate these data sets and analyze contributions from colleagues worldwide.

The international partners are expected to bring a variety of research expertise to BrainHub. Sun Yat-sen University will offer work from its medical faculty on Alzheimer’s disease and autism. Oxford University will offer contributions from its International Brain Mechanics and Trauma Lab. University of Warwick is contributing its expertise in digital health. And Indian Institute of Science is sharing work from its own brain institute.

CMU says it plans to encourage dissemination and commercialization of findings from BrainHub, and is expected to tap into its ProSeed and Simon Initiative funds to help get promising new projects off the ground.

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FDA Approves Low-Dose Anti-Inflammatory for Arthritis Pain

Knee brace (NASA.gov)

(NASA.gov)

25 August 2014. Iroko Pharmaceuticals LLC in Philadelphia says the U.S. Food and Drug Administration approved its low-dose formulation of the nonsteroidal anti-inflammatory drug diclofenac to treat pain from osteoarthritis. FDA in October 2013 already approved this drug, marketed under the name Zorvolex, as a treatment for mild to moderate pain in adults.

Osteoarthritis is the most common form of arthritis, where cartilage that cushions the joints breaks down, causing bones to rub together resulting in stiffness and pain, affecting some 27 million Americans according to the Arthritis Foundation. Symptoms often appear gradually and become worse with age, but are aggravated by overuse, obesity, previous injuries, and in some cases genetics. Treatments for osteoarthritis usually aim at relieving pain, since no cure is yet found.

Nonsteroidal anti-inflammatory drugs or NSAIDs are the most prescribed medications for relieving arthritis pain, with some common over-the-counter NSAIDs becoming household names, such as aspirin and ibuprofen. NSAIDs prevent two types of enzymes called cyclooxygenases from working. One form of cyclooxygenase is produced when joints become hurt or inflamed, while the other protects the stomach lining from harsh digestive acids. As a result, NSAIDs can relieve inflammation and pain in the joints, but can also cause stomach upset and bleeding.

Because of these and other adverse effects, FDA in 2007 prepared a medication guide including a recommendation that NSAIDs be used in the lowest dose possible and the shortest time needed. In response to that recommendation, Iroko developed its formulation of diclofenac, an NSAID already prescribed for various pain conditions, including osteoarthritis and rheumatoid arthritis.

The company’s formulation, however, is designed to work in lower dosages. Iroko obtained a license to apply a manufacturing technology developed by iCeutica, also in Philadelphia that mills drug particles down to sub-micron (less than 1 millionth of a meter) size. Iroko has exclusive rights to apply iCeutica’s technology for pain medications. In the case of Zorvolex, Iroko’s particles are 20 times smaller than the original, providing a larger surface area to expose diclofenac for pain relief, thus making lower doses possible.

Iroko says FDA’s approval of Zorvolex was influenced by results of a late-stage clinical trial testing the drug against a placebo among 305 adults, age 40 and higher, with hip or knee pain caused by osteoarthritis. Patients in the trial were randomly assigned to receive 35 milligram capsules of Zorvolex two or three times a day, or a placebo for 12 weeks.

The trial looked primarily at scores on a standard index of reported osteoarthritis pain at the beginning and end of the 12-week period. Results showed patients taking Zorvolex three times a day were more likely to report more pain relief after 12 weeks than those taking the placebo. Patients taking the drug twice a day also reported more pain relief than the placebo group, but the differences were not large enough to be statistically reliable. The most common adverse effects among those taking Zorvolex were  diarrhea, headache, nausea, and constipation.

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Trial Crowdsources Lung Cancer Biomarker Screening

Lung cancer X-ray

(National Cancer Institute)

22 August 2014. A clinical trial at University of Colorado Cancer Center in Aurora is recruiting participants through an online campaign to find people with lung cancer that meet a specific genetic profile who would most likely respond to the drug being tested. The study is led by Ross Camidge, director of the center’s thoracic oncology clinical program.

Camidge and colleagues are attempting to find participants for the study with locally advanced or metastatic (spreading) lung cancer and an alteration in the Fibroblast Growth Factor Receptor 1 or FGFR1 gene. Patients with either small cell or non-small cell lung cancer are eligible. When FGFR1 genes trigger an excess amount of enzymes, they can cause reactions that feed solid tumor growth, such as cell division and blood vessel development

The Colorado researchers are testing the drug ponatinib, an inhibitor of enzymes expressed by the fusion of two genes, which is found in most patients with certain types of leukemia. Ponatinib, developed and marketed by Ariad Pharmaceuticals under the brand name Iclusig, is approved by FDA to treat those leukemia cancers, but has also been shown in preclinical tests to inhibit some enzymes expressed by genes in the FGFR family.

In the Fall of 2013, Ariad heeded an FDA request to suspend sales of Iclusig while the company addressed problems of blood clotting that arose among patients taking the drug. Ariad added new label warnings and limited the use of the drug, which enabled FDA to lift the sales restrictions in January 2014.

Because of the tight eligibility restrictions of the trial, the Colorado team turned to the Internet to locate participants. The study’s Web site asks prospects to complete an online screening questionnaire about lung cancer type and progression, and other items to determine eligibility.

Patients who may fit the initial criteria are then asked to send in a tissue sample, from either an existing or repeat biopsy, for the researchers to test for FGFR1 mutations. There is no charge for the FGFR1 mutation tests, but patients who pass the screening will need to fund their own travel to Colorado for the trial.

Camidge and colleagues aim to initially recruit 110 participants for the clinical trial, but eventually hope to enroll some 700 lung cancer patients. Along the way, the researchers plan to adjust the screening criteria as they learn more about the precise kind of FGFR1 mutations that respond to ponatinib. This approach to clinical trial recruitment promises to be markedly less expensive than traditional approaches that enroll large numbers of participants at many sites in the hope of finding a sufficient number of participants meeting precise criteria to test treatments.

In addition to crowdsourcing for trial participants, the Colorado researchers are turning to crowdfunding to raise money for the trial. Camidge has raised enough money from the university and Ariad to get the study started. “However,” says Camidge in a cancer center statement, “if this trial takes off, that’s probably only about half of what we’ll need.” A campaign on the crowdfunding platform Consano aims to raise another $25,000 for the study.

In the following video, Camidge tells more about the project.

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