My Clinical Trials Diary

A vitamin jab that shrinks tumours in a day is being hailed as a powerful new treatment for cancer. British researchers who are testing the therapy say injecting an extract of vitamin E into the bloodstream has a rapid effect. Within 24 hours, tumours begin to shrivel and after ten days they have almost completely disappeared. So far, research has focused on the vitamin's ability to find and destroy skin cancers. But scientists from the University of Glasgow and the University of Strathclyde, who led the research, are confident it will work for other types of tumours, too. Vitamin E is vital for helping the body to fight illness and is found in foods such as vegetable oils, cereals, nuts, green vegetables and eggs. It is rich in antioxidants that protect against disease by blocking damage from free radicals - harmful molecules that attack cells in much the same way as rust rots a car But for the past few years, one particular compound found in vitamin E has attracted attention a...

A bandage that gradually releases infection-fighting drugs and then dissolves once the wound has healed could help thousands of burns victims. The high-tech dressing, pioneered at Tel Aviv University in Israel, is designed to combat the high rate of infections among burns patients. It's estimated that as many as 70 per cent of patients with very severe burns die from infections that penetrate the body through damaged skin and wounds. Standard care involves regular cleaning and changing of bandages, which can disrupt the healing process. One of the major problems doctors face is that if these kinds of wounds are too dry, they won't heal fully; if they are too moist, there is a high risk of contamination by bacteria. To get round this, Israeli scientists have developed special fibres that are woven in such a way that they can 'store' significant quantities of antibiotic drugs. These fibres are used to make a dressing that sits on top of a burn and allows the medicine to s...

[1] Various methods are used to obtain specimens for hematocrit determination in neonates. We evaluated arterial sampling and found this method to be acceptable. Arterial values correlated closely with simultaneously obtained venous samples. Venous blood obtained with a tourniquet had a significantly higher hematocrit than that obtained without a tourniquet. [2] Influence of tourniquet application on venous blood sampling for serum chemistry, hematological parameters, leukocyte activation and erythrocyte mechanical properties Background: Venous blood sampling is usually performed using a tourniquet to help locate and define peripheral veins to achieve successful and safe venipuncture. Despite widespread usage of tourniquets for venipuncture by medical and laboratory staff, very few are aware of the effects of tourniquet application on laboratory parameters. In addition, definitive guidelines regarding when and how to use a tourniquet for blood sampling are lacking. The aim ...

Prescription Drugs Special Report Ever wonder how the medications you take act in your body? This brief guide explains how several classes of popular drugs work. Thousands of medications are in use today. Here are some of the most common mechanisms by which these drugs achieve their effects: Antibiotic Drugs -- The development of safe and effective drugs to cure infections was arguably the most significant advance in drug development of the 20th century. Perhaps the most famous example is penicillin, which is derived from a toxin produced by the fungus Penicillium notatum that contaminated a laboratory experiment. The Scottish scientist Alexander Fleming noticed that the Penicillium fungus had done something to kill the bacterium Staphylococcus, which is responsible for many human infections. Antibiotics have several modes of action. Penicillin disrupts the cell walls of bacteria, causing them to die. Some other antibiotics interfere with the ability of microorganisms to ...

Clinical trials offer you a chance to try new treatments. Should you participate in a clinical trial? Learn more about how clinical trials work. Courtesy: Mayo Clinic staff You may have heard about clinical trials — studies of possible new treatments or medications — but wonder what exactly they are and if one might be right for you. Choosing to participate in a clinical trial can be a complex decision. You first need to understand what clinical trials are and how they're used to test new treatments. What are clinical trials? Clinical trials are research studies designed to find answers to specific health questions. Clinical trials often look at new drugs or new combinations of drugs (new or old), new surgical procedures or devices, or new ways to use existing treatments. Clinical trials can also look at other aspects of care, such as: Preventing diseases Screening for and diagnosing health problems Quality of life for people with chronic illnesses Before a new approach c...

Now, all human clinical trials to be registered 15 Jun 2009, 0429 hrs IST BANGALORE: In a significant move aimed at making clinical trials on human beings more ethical and transparent, the Drugs Controller of India has ruled for the first time that all clinical trials taking place across the country in all areas of health - new drugs, treatments, therapies, surgical procedures and new medical devices - must be compulsorily registered. The rule will come into effect on Monday. Simply put, clinical trials and research conducted on human beings can now be accessed by the general public too. Hitherto, research institutions and companies obtained permission from the regulatory authorities and registration of the trials was voluntary. Now, the Drugs Controller General of India (DCGI) has asked the Indian Council of Medical Research to ensure that while granting permission for clinical trials, the applicants are advised to get the trial registered before initiation of the study. The new rule ...

Give Blood Pressure Drugs to All News Author: Fran Lowry  CME Author: Désirée Lie, MD, MSEd May 28, 2009 — Blood-pressure-lowering drugs should be offered to everyone, regardless of their blood pressure level, as a safeguard against coronary heart disease and stroke, researchers who conducted a meta-analysis of 147 randomized trials (comprising 958,000 people) conclude in the May 19 issue of BMJ [1]. "Guidelines on the use of blood-pressure-lowering drugs can be simplified so that drugs are offered to people with all levels of blood pressure," write Drs Malcolm R Law and Nicholas Wald (Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University of London, UK). "Our results indicate the importance of lowering blood pressure in everyone over a certain age, rather than measuring it in everyone and treating it in some." "Whatever your blood pressure, you benefit from lowering it furthe...

CDC clarifies preference on childhood vaccines WASHINGTON (Reuters) - Children who get a combined vaccine against measles, mumps, rubella and chicken pox are slightly more likely to have seizures compared to those getting two separate shots for the same diseases, U.S. officials said on Thursday. The seizures are not usually life-threatening and the U.S. Centers for Disease Control and Prevention said it was no longer expressing a preference that children get the so-called MMRV combined vaccine rather than two shots -- the MMR vaccine against measles, mumps and rubella (German measles) and a separate one against varicella (chicken pox). The CDC said it made the change after seeing evidence that children who got the combined MMRV vaccine faced an elevated, but still very small, risk of suffering febrile seizures after vaccination compared to those who got the two shots. A febrile seizure is a convulsion in young children associated with an increase in body temperature, often fr...

The capsule costs pennies, contains a simple cocktail of medicines, and halves the number of strokes and heart attacks. Doctors want to hand it out in the first mass medication for the middle-aged in Britain. So why are the big drug companies so uninterested? The magic bullet, containing five medicines in a single capsule, sharply reduced cholesterol and blood pressure levels and has the potential to "halve cardiovascular events in average middle-aged individuals", the researchers say. The finding is a major boost for a medication with huge potential against the worldwide epidemic of heart disease and stroke. Doctors say that, if further trials prove successful, all men aged over 50 and women aged over 60 should be offered the pill in what would be the first example of mass medication for the middle-aged in Britain. Yet no Western pharmaceutical company has shown interest in developing the so-called polypill because it does not promise big profits. It would sell for pennies b...

Answered by Dr Arun Bhatt in Pharmabiz.com Q. What is the definition of a legally acceptable representative (LAR)? As per Schedule Y, an LAR is a person who is able to give consent for or authorize an intervention in the patient as provided by the law(s) of India). This would usually include parents, adult children, adult siblings, and spouse. Q. Can a daughter-in-law sign as LAR for her mother-in-law in informed consent process? If mother-in-law is literate, you do not need an LAR. If mother-in-law illiterate, she can put her left hand thumb impression on the consent form. In this situation, you do not need an LAR but an impartial witness. In such a situation, the daughter-in-law will sign as an impartial witness. Q. Do we need to take DCGI approval for conducting comparative efficacy trials on already marketed drugs in India? Which one will be the comparator product in such cases among different old drug brands? You need to consider whether this study falls into one of the new drug c...

Here's wishing everyone a healthy and happy New Year! CLINICOM