Clinical Trials and Medical Blog

Every drug that makes it to the pharmacy shelf must leap over numerous hurdles, starting with experimentation in the lab, followed by clinical trials in humans and culminating with the scrutiny of the U.S. Food and Drug Administration (FDA), which must review and approve all proposed new medications for safety and effectiveness before they can be sold to consumers. The process can take upwards of 10 years, and clinical testing is the trial by fire that makes or breaks any prospective new drug.

Pharmaceutical companies also test drugs that have already been approved, to monitor long-term safety and effectiveness. Additional labeling claims or proposed new uses of drugs previously approved for commercial sale must be evaluated in subsequent clinical trials.

New medical devices and even new procedures and approaches to diagnosing or treating diseases must undergo clinical testing to prove their merit. A study might ask whether using a particular drug in addition to surgery is better than surgery alone, or whether earlier, more aggressive treatment of a condition produces a better outcome. Any question health care professionals might have about how best to diagnose and treat a medical condition may be addressed scientifically by a clinical trial.

Clinical trial results themselves must pass a test as well. Results of safety and/or efficacy must be “statistically significant”. That means a mathematical analysis of the results must show that the results obtained are highly likely to be “true” and not the result of chance.

Risks and benefits of taking part in a clinical tria

Why do people participate in clinical trials? Some people who are very ill or who are not responding to standard treatments join clinical trials in order to receive new, investigational treatment. They are hoping that this treatment, possibly a new drug, medical device or procedure, will work better for them than standard therapy. Others participate in clinical trials to contribute to medical science, while others take part for the chance to try the newest treatment that they hope will work better than the current standard.

Participation in a clinical trial brings a host of potential benefits and possible risks for the consumer. The benefits include access to new treatments otherwise unavailable as well as an opportunity to help others by contributing to medical research. Sometimes, it also means access to top medical care, although the majority of FDA approved clinical trails, are conducted in community practices. If a treatment proves effective, you, as the participant in the clinical trial, may be offered the treatment, even if you have been in the control group.

When you enroll in a clinical trial, however, you should be aware of the potential risks associated with the study. You may also be signing up for some inconveniences. The treatment may have side effects or produce adverse reactions with other medications or foods. You may receive a placebo (although they are not used in cancer trials), or you may receive the experimental treatment but not derive any benefit. If there is an existing effective therapy, weigh your options carefully in light of the fact that you may get only a placebo treatment. Another factor to keep in mind is that the design of the trial may require frequent trips to the study site, hospital stays, or difficult or uncomfortable procedures.

Clinical trials, at least late-stage trials, may not be as risky as most health care professionals and participants believe. An initial 1999 review of 25 studies found that outcomes were better overall for participants in Phase III clinical trials than in those who did not join a clinical trial. The surprising results suggest the need for a broader analysis; if confirmed, additional studies could address the reasons for the so-called “inclusion benefit.” It could be, for example, that volunteers for trials tend to be more conscientious about their health, or that the more attentive care provided in trials makes a significant difference.

Clinical trial sponsors may include government agencies, such as the National Institutes of Health (NIH); pharmaceutical or medical device companies; individual physicians; or health care institutions. Trials may be conducted in a variety of locations: hospitals, universities, doctors’ offices or community clinics.

We all know that eating too much salt is not good for us, but how much do we have to reduce to make an impact? According to a new study - not very much at all!

Eighty patients with untreated mild to moderate hypertension were randomised to either start a ‘no added salt’ diet or continue with their normal diet.

24 hour holter monitoring and urinary sodium excretion measurement were carried out six weeks after the start of the diet.

Although sodium excretion dropped significantly in the ‘no salt added’ group of patients – compared to the control group - only 36% of them reached the pre-treatment goal of 24 hour sodium excretion of 100mEq/l.

But mean BP significantly dropped during the day by 12.1/6.8 and at night by 11.1/5.9mmHg.

Read the full article

Tea Tree Oil is one of the most useful products in nature. It has been used by some Aboriginal People in Australia for many centuries as one of their most useful medicines. Tea Tree oil is derived from Melaleuca Alternifloria which is a narrow-leafed paper bark tree that is native to certain parts of Australia. Some people think that it is called the Tea Tree because Captain Cook, who sailed from England in the 17th Century, used the leaves to make a tea from when they first voyaged to Australia, hence the name Tea Tree. Captain Cook found that it was good at combating scurvy a disease that many of his crew suffered from at that time due to a lack of fresh fruit and fresh vegetables.

Australia has more than 300 different kinds of Tea Tree, but only one of them is used to make the oil which is now world famous. Tea Tree Oil first came to prominence during the First World War in the early 20th century. Australian soldiers were seen to be using the oil to treat their infections. They had a great deal of success with this. During World War Two, Tea Tree Oil growers were exempt from National Service in Australia as their contribution to the war was to produce Tea Tree Oil for use by its troops.

Tea Tree oil has a number of fantastic properties making it an excellent treatment for many complaints. These are all external uses as Tea Tree oil should not be taken internally.

Tea Tree oil has been shown to be effective against Fungi, Bacteria and Viruses. It is extracted as an essential oil by steam or water distillation from the leaves and twigs of the Tea Tree. The oil is a water-white liquid or pale yellow-green. It has a fresh, spicy and slightly camphoraceous smell.

Have you been a little lightheaded lately? If you happen to set your eyes on an object and you see it spinning, then your dizziness may lead to something serious. If your wooziness is coupled with a whirling sensation, chances are you may be experiencing vertigo. Vertigo is a medical term for dizziness that can lead to a balance disorder.

Vertigo is also known as “hallucination of motion”. Individuals having this ailment begin to see blurred motions of stationary objects. It has almost the exact feeling of being in an unstoppable merry-go-round.

It may be left untreated many times, but vertigo is actually one of the most widespread medical problems among adults. In United States alone, around 40% of individuals experience the symptoms of vertigo at least once. This fact is so reported by the National Institutes of Health (NIH). Studies show that vertigo is more common in women than in men and as a person grows older, he or she may experience more frequent attacks of vertigo.

Vertigo is usually associated inner ear infection, which is also referred to as labyrinthitis. Fluid-filled canals or labyrinths have very small hair cells that are responsible for sending impulses to the human brain. The brain then identifies the individual’s correct body orientation. Once the small organs in the labyrinths gets irritated, then these cells may send incorrect messages to your brain. When this happens, you would feel a sudden drowsiness. Since the ear is responsible for the body’s balance, once your ears are malfunctioning you may often observe yourself getting dizzy and out of balance.

Vertigo can also be caused by balance disorders and inflamed vestibular nerves. If you are physically injured in a part of your ear, chances are you would suffer from vertigo as well. It is important to take not that vertigo is not a disease in itself. It may be a symptom to a more complicated illness like tumor and stroke.

At the first signs of vertigo, immediately consult your doctor for proper advice. The common treatment for vertigo is meclizine. The symptoms of vertigo usually go away on its own but comes back after a few weeks or so. If you experience any signs of vertigo, never tell yourself that’s it’s just a simple headache and would soon go away. As passé as it may sound, prevention is always better than cure.

The extracts of Allium sativum bulb and compound preparation possess pharmacodynamic properties. The extract of garlic was found to have a significant protective action against a fat induced increase in serum cholesterol and plasma fibrinogen and in fibrinolytic activity.

Garlic is used as a carminative, aphrodisiac, expectorant, and stimulant.

Anticancer Actions:

Human population studies show that eating garlic regularly reduces the risk of esophageal, stomach, and colon cancer. This is partly due to garlic’s ability to reduce the formation of carcinogenic compounds. Animal and test tube studies also show that garlic, and its sulfur compounds, inhibit the growth of different types of cancer-especially breast and skin tumors.

Circulatory Effects:

More than 250 publications have shown that garlic supports the cardiovascular system. It may lower cholesterol and triglyceride levels in the blood, inhibit platelet stickiness (aggregation), and increase fibrinolysis-which results in a slowing of blood coagulation. It is mildly antihypertensive and has antioxidant activity.

Antimicrobial Actions:

Garlic has antibacterial, antiviral, and anti-fungal activity’ It may work against some intestinal parasites. Garlic appears to have roughly 1 % the strength of penicillin against certain types of bacteria. This means it is not a substitute for antibiotics, but it can be considered as a support against some bacterial infections. Candida albicans growth is inhibited by garlic, and garlic has shown long-term benefit for recurrent yeast infections.

High Blood Pressure:

Garlic is regarded as one of the most effective remedies to lower blood pressure. The pressure and tension are reduced because it has the power to ease the spasm of the small arteries. It also slows the pulse and modifies the heart rhythm, besides relieving the symptoms of dizziness, shortness of breath and the formation of gas within the digestive track As these days garlic capsules are available with the chemist shops, the average dosage of two to three capsules a day to be given to make a dent in the blood pressure.

Digestive System Disorders:

Garlic is one of the most beneficial foods for the digestive system. It exercises a beneficial effect on the lymph, aids in elimination of noxious waste matter in the body. It stimulates peristaltic action and the secretion of the digestive juices. Crushed cloves of garlic may be infused in water or milk and taken for all types of disorders of the digestion. It has an antiseptic effect and is an excellent remedy for infectious diseases and inflammations of the stomach and intestine. The oil of garlic is absorbed into the alimentary tract and is eliminated partly through the urine.

Garlic produces a very marked effects on the intestine. It is an excellent agent as a worm expeller. It has also a soothing effect on the various forms of diarrhoea. Problems such as colitis, dysentery and many other intestinal upsets can be successfully treated with fresh garlic or garlic capsules One garlic capsule taken three times a day is usually sufficient to correct mild cases of diarrhoea or dysentery. For more persistent cases, upto six capsules a day can be taken. Garlic has the ability to destroy harmful bacteria in the intestines without affecting the beneficial organisms which aid digestion.

Skin Disorders:

Garlic has also been used successfully for a variety of skin disorders Pimples disappear without scar when rubbed with raw garlic several times a day. Even very persistent form of acne, suffered by some adults, has also been healed with garlic. The external use of garlic helps to clear the skin of spots and pimple, and boils. The process is further helped by taking the garlic orally also, to purify the blood-steam so as to secure a long term clearance of the skin. A regular course of three garlic capsules per day should help to clear minor skin infections quickly.

Whooping Cough:

Garlic is an excellent remedy for whooping cough. Syrup of garlic Should be given in doses of five drops to a teaspoonful two or three times a day in this condition. It should be given more often if the coughing spells are frequent and violent.

A phase II trial on axitinib, a new experimental drug for treating patients with cytokine-refractory, metastatic kidney cancer who have a poor response to more traditional drugs has shown promising results according to a new study published in the The Lancet Oncology.

In an intention to treat analysis, the study produced the following results:

• Of the 52 patients, 2 responded completely and 21 partially.
• This equated to an objective response rate of 44.2 per cent.
• The median response rate was 23.0 months (range 4.2 to 29.8 months).
• But 12 of 23 initial responders progressed with response durations of 4.2 to 26.5 months.
• Also, 22 patients showed stable disease for more than 8 weeks, with 13 of them for 24 weeks or more.
• 4 patients had early disease progression, 3 had missing response data.
• Median time to progression was 15.7 months (range 0.03 to 31.5 months).
• Median overall survival was 29·9 months (range 2·4 to 35·8 months).
• Adverse events linked to treatment included diarrhoea, hypertension, fatigue, nausea, and hoarseness.
• High blood pressure was found in 30 patients.
• Of these, all but 8 responded to blood pressure treatment. 7 of the 8 had a history of high blood pressure at enrollment.

Read more here

Nasal labial folds: you know - the folds and lines (wrinkles) that are determined to develop into permanent grooves on the side of your mouth, in your cheeks and up to your nose. They’re more than just laugh lines. Even if they were formed by laughing, you don’t feel like laughing now because every time you see them, you know they are winning the war of aging.

Flabby muscles make you look older; if your arm muscles jiggle, those muscles need exercise. If your thighs look dimply or the skin on your upper inner thigh feels thickly soft, you can firm and tone that area with exercise. The same with a thick waist, a droopy backside or a bulging tummy; exercise is the solution.

An exercised body looks streamlined; improved posture means you no longer slouch and your tummy looks flatter because your core muscles have new life and strength; they’re in better shape from oxygenated blood, contractions and resistance.

The face and neck muscles can become flabby, too. When these muscles soften and then droop, it is blatantly apparent that something unflattering is occurring.

Mind you, aging in the face is sinister because it takes a lot of years for faces to develop lines, folds and sags. By age forty, most people are seeing the early stages of muscle atrophy when their eyelids feel and look heavy, by fifty, the jaw feels spongy and you see that droopiness is affecting your good looks.

The look of old will affect your confidence and no matter how you wear your hair, or how much makeup you use, you will still see sagging. You can disguise a multitude of aging in the body by the clothes you wear – black, loose fitting clothing can conceal waist, tummy, hips, thighs and arms but how can you mask aging in the face?

Thankfully, there are safe and sane techniques that will save your face and they are easy to master. Facial exercises will quickly isolate the affected areas of your face and in just minutes a day, you can deliberately, systematically, and consistently help your face look healthier, prettier, and younger.

These exercises are not contortions; rather, they are isometric and resistance exercises that will shape and contour your face easily and simply without the high costs typically associated with cosmetic or plastic surgery.

From the moment you begin this incredible transformation process, you will see and feel the difference in your muscles and skin every time you perform the exercise movements.

Successfully exercising your cheeks to lift those laugh lines requires you to learn how to anchor the muscles near the nose so when they contract they reposition higher near the ear in the hairline. Have you stood in front of your mirror and pulled the hairline up and back just wishing you could iron out those lines that run from the nose to the mouth?

Exercise helps this to happen. Not just one exercise. Several exercises target specific muscles and muscle groups to contract the cheek muscles up and back to the ear. Contractions and resistance movements plump up the muscles, helps the skin to look healthier from the increased blood supply and gives your face a toned and tightened look.

The muscles in the face weave over and under each other; one end attaches to bone, the other end attaches to either skin or another muscle. This means that when the muscles begin their downward slide, they pool into other muscles and muscle groups, depressing the face making one look tired and even old.

You can stop this.

Surgeons do not want you to know that you can shape and contour your face with facial exercise. They want you to believe that you need injections, surgery and other costly modalities to keep you looking younger.

Exercise is so easy and it makes sense. Consider this, in just minutes a day you can create visible changes that will turn into lasting results. In the privacy of your home, using only your thumbs and fingers, you have the power to reshape and contour your face so that you look younger and healthier without surgery, injections or risky procedures.

For the rest of your life, this exercise program will work for you and you can forever look substantially younger. It’s the best kept secret!

It is that time of year when the Flu is flourishing in the workplace, classrooms, hospitals, and homes. The influenza virus differs from the common cold in the sudden onset of symptoms. These are severe headaches, fever, chills, muscle aches and sometimes, nausea and diarrhea. The following are some strategies to stay healthier, this flu season.

Get the flu shot. There are three types of flu. However, the type A virus is constantly changing which tricks the body into believing that it is fighting a new virus. The flu shot is the best line of defense in fighting the flu which is most prevalent.

Stay home when ill. Even though the common mode of thought is to drag our bodies to work when we are sick, it is not necessarily the best mode of thought. Studies have shown that sick and ill workers actually reduce productivity which costs the company money, not to mention the inconvenience to other workers who are infected. Use your sick time.

Wash your hands frequently. The key to removing germs, which could spread infection, is soap, water and friction. Wash your hands briskly and frequently. Keep a hand sanitizer on your person or near you, when a restroom is not readily available.

Eat yogurt or take a supplement containing probiotics. Probiotics are nature’s friendly germs. A large percentage of immune cells, that ward off disease, live in our digestive tract. Keeping a larger percentage of probiotics or beneficial bacteria to harmful bacteria in our intestines helps to ward off colds and flu.

Hydrate your environment, inside and out. Keep a few bowls of warm water around your house to increase moisture inside your house. Drink six to eight glasses of water a day. A lack of adequate hydration lowers the immune system making you susceptible to colds and flu. Drink tap, purified or spring water. Distilled water contains no minerals.

Eat a rainbow of fruits and vegetables. Colorful berries provide a natural mix of antioxidants. Orange vegetables are a great source of beta-carotene. Citrus fruits are rich in vitamin C. Thinking in terms of a rainbow of color, of different fruits and vegetables, will ensure that you get the vitamins necessary for good health.

Make sure to get adequate sleep. The average American subsists on two hours less sleep, a night, than our ancestors. Studies suggest that most of us require a little more than eight hours of sleep a night. Lack of adequate sleep causes our bodies to produce fewer antibodies, resulting in a lower immune system. Adequate sleep is crucial to good health.

Have a regular exercise regimen. Moderate exercise, thirty to sixty minutes, three times a week helps boost immunity. An exhaustive workout can suppress the immune system for the short term. Find an exercise regimen that works for you.

All of these strategies will help you to live a healthier life, as well as provide protection against the flu. Try and make these strategies a part of your everyday life and you should be rewarded with less colds and flu when the flu season hits.

A team at Newcastle University are beginning a trial this week that could give hope to thousands of sufferers of muscular dystrophy.

A new treatment called molecular patch therapy has been developed which has the potential to give boys born with Duchenne Muscular Dystrophy (DMD) the chance to preserve their muscle function and live into old age.

In a world first, the antisense oligonucleotide (AO) patches work by masking the faulty part of the gene (exon 51) and allowing shortened but functional proteins to be formed.

DMD affects one in 3,500 boys and is caused by reduced production of dystrophin protein - vital for muscle function. The progression of the condition is so severe that untreated boys lose the ability to walk by their early teens are only expected to live into their twenties.

From the Newcastle University website:

“This is a major breakthrough for the treatment of DMD,” said Professor Francesco Muntoni, head of the neuromuscular unit at Imperial College Healthcare NHS Trust, “as conventional gene therapy approach for this disorder has proven to be problematic. Animal work has suggested that the molecular patch has worked well and showed a very significant restoration in dystrophin function”.

Professor Kate Bushby and Professor Volker Straub from the Institute of Human Genetics at Newcastle University will be recruiting nine young men from across the country and preparing them for the treatment. The trial participants will need to be aged 12 – 17 with DMD and they will have the molecular patch administered by injection into a small muscle in the foot. Subject to the trial’s success, there is already a plan to proceed with another trial to deliver the molecular patch under the skin, so that all muscles in the body could be treated.

Professor Bushby of Newcastle University said ”This is very important work to be involved with and a reflection of the long -standing interest in muscular disease here in Newcastle. We’re one of only three specialist centres in the country and this is the first step to what might be a gene based therapy for Duchenne Muscular Dystrophy.”

Read the full story here

Nuts of all kinds (I am talking peanuts, cashews etc) have a mixed reputation. They are high in fat, but have no carbohydrates. Many people I know will not eat any type of nut because of their high fat content. Nuts have a very important role in a healthy weight loss plan.

First, the fat in nuts is 90% percent unsaturated, which means it helps keep your arteries clean of cholesterol. Remember saturated fats, make you fat and clog your veins, unsaturated fats only cause you to gain weight. Do not let that scare you off; we need some fats in our diet.

Second, nuts have of no carbohydrates or sugar, which means they do not cause any insulin release, which is associated with weight gain. They are also so a great source of protein, one of the best of any non-meat food.

Do not go over board, nuts do have a lot of calories. But they also stay with you along time. If you find you are hungry between meals, have your self a serving of nuts. Make sure to eat one serving, read the label.

They can keep you from being hungry, because they have a lot of fat and protein. They also do not trigger the body to release insulin, which can cause you to get hungry.

Do not eat more then one serving a day. Any type will do so eat which ones you like they all have the same basic nutrients. They will also help you lower your cholesterol, because of the high amount of unsaturated fats.

I know they have some fat, but if your weight loss plan is good and you the nuts by them selves, with out any type of sugar you will be fine. Drink water or diet soda pop with them. If you are watching you sodium you may want to eat unsalted nuts, or talk about with your doctor.

So, the next time your need a quick snack, grab a handful of cashews, almonds or peanuts and enjoy.