Clinical Research

The question whether all human clinical trials undertaken in India are conducted ethically has been answered. The final report of the three-member committee appointed by the central government to go into the alleged irregularities in the conduct of the human papilloma virus (HPV) vaccine trial reveals gross ethical violations. The trial, suspended since March 2010, was carried out by the Program for Appropriate Technology and Health (PATH), an NGO, in collaboration with the Andhra Pradesh and Gujarat governments and the Indian Council of Medical Research. It was conducted on nearly 23,500…

Clinical trials are a set of procedures in medical research  conducted to allow safety (or more specifically, information about adverse drug reactions  and adverse effects of other treatments and safety and efficacy  data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). These trials can take place only after satisfactory information has been gathered on the quality of the non-clinical safety, and Health authority/ethics committee approval is granted in the country where the trial is taking place. Depending on the type of product…

What helps can sometimes hurt.     ERBB4, a gene known to be important in cardiac development, has been associated with congenital heart malformations that result in obstruction of the left ventricular outflow tract.  Left ventricular outflow tract (LVOT) malformations, including aortic valve stenosis, coarctation of the aorta, hypoplastic left heart syndrome, Shone complex and interrupted aortic arch type A, are responsible for a major portion of childhood death from congenital heart malformations. Yet it is often unclear how these defects develop. Recent studies suggest a…

If you’ve been managing type 2 diabetes for a while, you know that current advice is to maintain your glucose levels at 7 percent or less, as this is where blood glucose levels are for non-diabetics. A large observational trial published online this week, in Diabetes Care, however, raises questions about this long-held advice in people over the age of 60. The new study published this week involved 71,092 people with type 2 diabetes who were all 60 years or older. As expected, the researchers found that those participants with very high blood sugar levels had higher risks of complications…

In 2003, Rollin McCraty, the Director of Research at the Institute of HeartMath in Boulder Creek, California, published an e-book called The Energetic Heart: Bioelectromagnetic Interactions Within and Between People. In it he explains his research on an electromagnetic field created by the heart that he believes communicates with the brain and the body simultaneously, and affects those around us. In one study, McCraty monitored six longtime married couples’ heartbeats while they slept alongside each other. Both heartbeats fell into harmony, beating in sync. Electrocardiogram printouts of each…

BERN, Switzerland, April 21, 2011 /PRNewswire/ -- CSL Behring announced today that the European Commission has granted marketing authorization for Hizentra(R) (Human Normal Immunoglobulin), 20 percent solution for subcutaneous injection, for treating patients diagnosed with primary immunodeficiency (PI) as well as secondary immunodeficiencies. This authorization is valid for all 29 European/European Economic Area member states. CSL Behring is a subsidiary of CSL Limited . Hizentra is currently marketed in the United States. It received U.S. Food and Drug Administration approval in March…

Case study: Patient Ashley has Hermansky-Pudlak Syndrome, a rare genetic disorder characterized by albinism, vision impairment, and bleeding disorders such as chronic hemorrhages. H-PS is particularly damaging to the lungs. Location: "Children's Gala" auction for the Children's Inn at National Institute for Health (NIH) Situation: Subject is singing. Analysis: Measuring the baseline and improvement in the subject's singing is a valid diagnostic tool for tracking improvement of lung capacity. ... I'm at the Children's Gala, overbidding on a shawl and enjoying tasty food courtesy of our table…

ORLANDO, Florida,, April 4, 2011 /PRNewswire/ -- Berg Diagnostics, a member of the Berg Pharma, Inc group of companies with Berg Biosystems and Cytotech Labs, is a Boston-based molecular diagnostics company that officially launched its molecular diagnostics services and products at AACR meeting from April 2nd - 6th in Orlando, Florida. The company offers enabling technologies such as high-throughput omics-based molecular profiling, biomarker validation, and regulated bioanalysis, facilitating its client base to decipher differential molecular signatures between normal and disease states,…

NEW ORLEANS, April 3, 2011 /PRNewswire/ -- Abbott today announced positive one-year results from 101 patients enrolled in the second phase of the ABSORB trial evaluating the world's first drug eluting Bioresorbable Vascular Scaffold (BVS) for the treatment of coronary artery disease. These results were presented during the American College of Cardiology's (ACC) 60th Annual Scientific Session and i2 Summit 2011 in New Orleans. At one year, Abbott's ABSORB device demonstrated a low 6.9 percent rate of major adverse cardiac events(1) (MACE) and no reports of blood clots (thromboses). In an…

Despite the culture war on smokers, the idea that cigarette smoking causes lung cancer or lung disease is largely a myth.   Anti-smoking groups are a multi-billion dollar industry on their own and continued marketing is a key part of maintaining the revenue stream but only 10% of smokers get lung cancer and 50% of lung cancer victims never smoked. However, cigarette smoking is obviously not good for you so you shouldn't do it, and work continues to determine how smoking impacts risk factors for diseases. Given that smoking has been in the news for so long, it may surprise you to learn…