Clinical Trials – Facts to Consider About New Treatment Options

Clinical trials are biomedical research studies aimed at determining the efficacy, safety levels, and possible side-effects of new medications and therapies. The majority of clinical trials involve testing new medications designed to treat many types of conditions, ranging from auto-immune and blood diseases to cancer. In the case of new medications, the trials are jointly run by pharmaceutical companies, which are responsible of designing the new drugs, and hospitals or health centers, which administer them to patients.

clinical trials

Clinical Trial Facts to Consider Before Enrolling

Most people who consider enrolling for clinical trials do it because existing commercially available drugs and treatments have not succeeded in curing their ailments. Others do it so that doctors and scientists can gather as much information as possible in order to treat diseases. Patients considering participating in clinical trials should analyze several factors, including the mechanisms by which the drugs act, the phase that the clinical trial is in, the inclusion criteria, the potential side effects, and the availability of alternative treatment options, before reaching a decision.

Types of Clinical Trials

According to the US National Institute of Health, there are five types of clinical trials, according to their purpose and treatment options.
  • Treatment Clinical Trials: new drugs, therapies or surgical procedures are tested on patients.
  • Prevention Clinical Trials: new medications, vaccines or vitamins are given to people in order to prevent diseases.
  • Diagnostic Clinicial Trials: involve testing new methods to diagnose diseases or conditions.
  • Screening Clinical Trials: new ways to detect conditions are tested.
  • Quality of Life Clinical Trials: new ways to improve the quality of life for individuals which chronic illnesses are tested.
On the other hand, some clinical trials may involve giving placebos, whether knowingly or unknowingly, to some of the participants. It is important for people considering enrolling in clinical trials to find out whether they could be receiving placebos or new medications.

Phases of Clinical Trials

New medications have to go through five phases of clinical trials before they can be approved by the FDA or corresponding health authority. In total, the development of a new drug can take up to 10 years and pharmaceutical companies usually spend millions of dollars in the process. For this reason, clinical trial protocols have to be carefully planned and followed so that as many external variables can be eliminated while testing the new medications. (Meinert, 1986)
The phases of clinical trials are as follows:
  • Pre-Clinical Studies:This stage involves testing the drugs on lab animals in order to get preliminary information about the new medication’s toxicity, efficacy, and pharmacokinetics, or, in other words, how the body processes and eventually eliminates the drug.
  • Phase 1 Clinical Trials: This is one of the most important stages of clinical trials since it involves the first time a new medication is tested on human beings. Phase 1 clinical trials usually accept between 20 and 100 participants and they are done to determine safe dosage ranges and side effects.
  • Phase 2 Clinical Trials: The new medication is given to a larger group of people (100 to 300) in order to further assess its effectiveness and safety.
  • Phase 3 Clinical Trials: The purpose of phase 3 clinical trials is to confirm a drug’s effectiveness, to monitor its side effects, and to compare it with existing treatment options. It usually involves between 1000 and 3000 participants.
  • Phase 4 Clinical Trials:Also known as post marketing surveillance trial, this stage involves the safety surveillance of a drug after it has been granted permission to be sold in the market. It determines possible interactions of the new medications with other drugs and detects long term side effects.

Benefits of Participating in Clinical Trials

When all treatment options have been explored, some patients can only resort to clinical trials in order to treat their condition. Participants will usually receive expert medical care and their progress will be closely monitored. On the other hand, pharmaceutical companies and hospitals usually agree to provide medications to patients even after they have been accepted by health regulation agencies.

Considering the amount of time and money that the companies spend developing new medications, this means that participants could avoid spending large sums of money on expensive drugs once they are widely available.

Risks of Participating in Clinical Trials

It is clear that people participating in phase 1 clinical trials are subjected to greater risks than those enrolled in later phases. Sometimes unpredictable side effects could appear while new medications are first given to human beings. Since pharmaceutical companies and hospitals need to be very thorough during clinical trials, sometimes they place restrictions on participants. Some are not allowed to eat certain foods or vitamins, travel overseas or have to go to hospital to be routinely monitored. People interested in participating in clinical trials should carefully read the informed consent form to find out about these possible inconveniences.

Benefits And Risks Should be Weighted Before Participating in Clinical Trials

Clinical trials are necessary for the development and release of new medications to the market. Before participating in one, people should analyze the potential benefits and risks involved, as compared to existing treatment options. In the end, participating in a clinical trial can save a patient’s life. On the other hand, depending on particular circumstances, clinical trials can also cause inconveniences or even undesirable side-effects. A very useful site containing information on clinical trials run all over the world is ClinicalTrials.gov, run by the US National Institutes of Health.


Disclaimer: The information contained in this article is for educational purposes only and should not be used for diagnosis or to guide treatment without the opinion of a health professional. Any reader who is concerned about his or her health should contact a doctor for advice.

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Cigarette Smoking Causes Addiction: The Debate Ends

cigarette smoking

One in every five deaths in the United States is caused by smoking. The National Institute on Drug Abuse (NIDA) which functions under the U.S. National Institutes of Health (NIH) conservatively estimates that the U.S. economic burden of smoking is $193 billion every year.

Smokers Use Tobacco Because They are Addicted

NIDA puts an end to the age-old controversy whether cigarette smoking is an addiction or not. It says conclusively that most smokers smoke because they are addicted. Nicotine, an ingredient of tobacco causes the addiction. The American Heart Association says that nicotine addiction has remained one of the toughest addictions to break.

There is sufficient research and documented evidence to show that most smokers are aware of the dangers of smoking, and wish to quit the habit. However, over 85% of smokers that try to quit smoking go back to it, most of them within a week.

How Nicotine Works

Research has established that nicotine impacts the brain in numerous ways. NIDA says that the research findings have shown how nicotine triggers reward pathways, which are a part of the nervous system that manages the sense of pleasure. One of the critical brain chemicals associated with the urge to take a drug is dopamine. Research shows that nicotine enhances dopamine levels in the brain.

When such alterations in the brain occur over a prolonged period of time due to persistent exposure to nicotine, it causes addiction. The delivery mechanism of nicotine to the brain is very efficient in the case of cigarette smoking. Nicotine reaches the brain very fast and the level of drug peaks within 10 seconds of smoke inhalation. This property of nicotine adds to its abuse potential.

Withdrawal Symptoms of Smoking

The addictive nature of tobacco is also evident from the fact that the addicts suffer from withdrawal symptoms very quickly once they stop smoking. Most smokers start feeling nervous, anxious, depressed and irritable, and experience an abnormal increase in appetite, disturbed sleep patterns and attention deficit. As a result, most of them feel compelled to go back to cigarettes.

Smoking cessation leads to peaking of the symptoms within the first few days, but there is a gradual reduction in the severity of symptoms with the passage of time. The intensity of withdrawal symptoms varies from one person to another.

New Research Reveals More Addictive Elements

Nicotine may not be the only culprit present in tobacco smoke that causes addiction. Research funded by NIDA reveals that there may be other ingredients too that influence the addictive potential of tobacco. The role of other ingredients in causing addiction is not yet conclusively established, but there are indicators pointing in that direction.

Research conducted on animals by NIDA’s research teams has identified acetaldehyde as another critical chemical found in tobacco smoke that causes an exceptional increase in the reinforcing properties of nicotine. In addition, Acetaldehyde may also be a direct contributor to the addiction of cigarettes.

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Clean Drinking Water

clean drinking water
Our bodies are 70 percent water. If we do not adequately hydrate our bodies they cannot function adequately.

A Cure-All

The water that we drink and consume in food is a carrier, bringing food to our cells and taking away wastes. Making sure that you get plenty of high-quality water every day is one of the most promising routes to digestive wellness. Clean water and good hydration can help prevent many health conditions, from gout, to asthma, and ulcers.

Tap Water

There is more than one good answer about where to find the best drinking water. Tap water can be very polluted because of pollutants that leak into the ground and contaminate the water supply. There is a lot of controversy over the amount of chlorine in tap water. The levels of chlorine needed to kill bacteria are rising due to increasing bacterial resistance, but chlorine has also been strongly associated with higher cancer risks. A simple water filter can efficiently remove chlorine from tap water. Activated charcoal systems are inexpensive and can also remove many pollutants from tap water.

Distilled Water

Distilled water systems and reverse osmosis are two systems recommended by many experts. The downside is that the water distillation process removes all minerals from the water. Because of this, regular consumption of distilled water can lead to a leaching of minerals from the body. Reverse osmosis alone does not kill all microbes, so it may not be protective enough if you are concerned about bacterial contamination.

Ionized Water

Ionized water is the latest on the market. The water is put through micro-filters and then exposed to ultraviolet light, which kills all microbes. The machine can also alkalize water which makes it healthier to drink, ultimately making it less possible for them to become or stay ill.

Bottled Water

Often bottled water is just local, city tap water which has been carefully filtered. If you are buying spring water, make sure to read up in its source and its purity. If you buy water in plastic bottles, you may also be ingesting small amounts of plastic, which have known hormone-disrupting effects. On the plus side, bottled water can be an excellent source of essential minerals.

Using this easy guide, you can determine the best sources of clean, healthy drinking water. Being careful about the water you drink is an essential step to good health. Water is one of the most important substances that the body digests and you should be able to choose the best and healthiest kinds of water for your good health.

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How Scientists Studied Cell Phones & the Brain

While some states in the United States contemplate requiring labels on cell phones to warn of possible health dangers, scientists in Florida believe mobile phone use might actually promote brain health.

Cell Phones Brain

Two experiments were conducted. In both, they simulated cell phone use with an electromagnet force (EMF) radio transmitter under the mice’s cages. The transmitter sent radio waves at a frequency cell phones use (918 MHz) and at the same energy (250 mW/Kg) that human users receive from their phones. They simulated two one hour conversations every day.

Adolescent Mice Improved Brain Function

After about six months of twice daily hour-long simulated cell phone exposures, they tested young adult mice and compared results to control mice.

One of the tests they used was the radial arm water maze. In this test, mice are put on a platform in a tank of water that is partitioned into pie slices, with a circular cut-out in the center like the center of a target. One of the pie slices has an escape route. The test is how long it takes a mouse to find the escape. Another test used the radial arm water maze with physical cues (clues) to lead to the escape route. They also tested the mice's physical agility with challenges such as walking on a balance beam, and performing a task similar to tight wire walking. The investigators felt these mouse tests corresponded to tests used to evaluate people with possible Alzheimer's dementia.

At about six months, control mice (who didn’t participate in the simulated cell phone experience) deteriorated some in their performance, while one strain of exposed mice maintained or actually improved performance. The mouse strain that benefited was a transgenic strain destined to get an Alzheimer’s-like disease.

Adult Mice Benefited From EMF Exposure

Adult mice, five months old, were begun on the daily cell phone simulation experience protocol. Two months later, they were tested. After eight months of exposure, the 13 month old mice were tested. The transgenic mice who did not receive EMF deteriorated in performance, while the exposed transgenic mice “were strikingly better.”

The mice were sacrificed. The non-exposed transgenic mice had amyloid deposits in their brains. Amyloid is felt to be a major cause of the symptoms of Alzheimer's dementia. The exposed mice had “substantially lower (amyloid) burdens in both hippocampus (↓35%) and entorhinal cortex (↓32%),” two areas known to be where Alzheimer’s originates.

How EMF Might Be Helpful

The exposed mice also were slightly warmer. This may have been due to increased blood circulation. The effect was only seen after long term EMF exposure, suggesting possibly some blood vessel structural changes.

The investigators also suggest the beneficial effect might instead be from increased brain cell activity. Some studies using PET images found increased brain cell activity with short term cell phone use.

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Changing Habits

changing habits

Whether it’s nail biting, smoking or snacking, nearly everyone has a habit he wishes he could change.

Wendy Wood, who studies human behavior at Duke University, has found that location influences behavior. By changing locations and everyday movements, people can change their habits.

Wood, James B. Duke professor of psychology and neuroscience says, “Many of our repeated behaviors are cued by everyday environments.” While people may believe they are acting independently when they make certain choices, more often than not, they are simply acting on cues that they have responded to countless times in the past.

For instance, passing by the same vending machine at the same time every day can trigger the response to buy a snack. Driving by a fast food place each evening can trigger the desire to stop in for takeout. Deeply ingrained habits are very difficult to change through willpower alone.

Addicted to a Habit

Habitual behavior can be akin to addiction and the methods to break a habit are similar to those used to break an addiction. Avoiding people, places and things that trigger the need for the undesired habit can help lessen the impulse to carry out the behavior. It also helps to be very clear about the habit that needs to change and the best method to change it. Unlike addiction, however, once an old habit is replaced by a new one, there is little chance that it will be repeated, unlike in addiction, where the odds of repeating undesirable abuses are much greater.

Breaking a Habit

Just as in an intervention for an addiction, enlist the help of family and friends. While it may not always be applicable, it may help to hear loved ones talk about how your habit affects them. For instance, if snacking has caused a weight problem, perhaps loved ones are consumed with worry. If smoking is the culprit, friends may be disgusted or fearful for their own health.

Wood contends that by changing the situation in which a person habitually performs a behavior, it is possible to help erase a habitual action. Changing the environment that triggers a certain action can help retrain your brain to avoid the habit you want to break.

Imagine a man who hopes to beat his addiction to coffee. Every morning he sits at the breakfast bar with a cup of coffee and reads the paper. If he wanted to replace his morning coffee with fruit juice, he might try taking the paper to another room instead of the place where he habitually drinks coffee. By changing the situation, he can help retrain his habits.

Change a Habit

Habits are hard to change but it can be done with planning, discipline and willpower. Try altering the situation associated with an undesirable behavior to help create a new model for how to behave. And if it doesn’t work the first time, keep trying. It took a long time to create a habit and it may take a few weeks to retrain your brain to act in a new way.

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Causes of Migraines

migraines
Migraines can be defined as a serious headache that is accompanied with a range of symptoms such as visual disturbances, aura, nausea, vomiting and numbness. Women are three times more likely to experience a migraine than men, and it is thought that hormones have a role to play in this.

Pre-menstrual and expectant women are more likely to suffer from migraines due to increased levels of hormones in the blood. In fact, many women will experience a migraine for the first time ever whilst pregnant, with symptoms disappearing altogether once they have delivered.

Migraine Types

Migraines fall into one of two categories, classical or common. A classical migraine is one in which there are visual disturbances and aura for the patient, whereas a common migraine presents itself without visual problems.

Some patients only ever suffer from one type of migraine, whilst others can suffer both types. Stress is usually an indicator in the severity of the attack itself, which can last anything from a few hours to a few days, several times a week.

Stages of a Migraine

There are five definite stages for the onset of a migraine, although it is not necessary that a person will experience all of them. These are:
  1. Pre-headache or prodromal stage – this is a general change in a person's mood and behaviour before a migraine starts and can include aches and pains and a change in appetite. This stage can start days before a migraine.
  2. Aura – about 17% of patients complain about visual disturbances that include flashing lights, blurred vision, blindness and blind spots. These can last anywhere up to an hour.
  3. Headache stage – this is when the actual migraine takes hold and means throbbing and severe pain in one side of the head, often with nausea, vomiting and an aversion to bright lights and noise. The best solution is to lie down in a dark room and sleep it off. This stage can last up to three days.
  4. Resolution stage – this is when the pain subsides and gradually all symptoms fade away. Sleep usually helps to speed up this stage, and some people can even stop having a migraine as soon as they have been sick.
  5. Recovery or postdromal stage – this is when the migraine has gone, but can leave a person feeling drained and exhausted, or even elated in some circumstances.

Triggers for a Migraine

Migraine can be triggered by many things, the most common being food and stress. Other triggers can include the following:
  • lack of sleep
  • skipping meals
  • cheese, chocolate, citrus food and caffeine
  • shock
  • depression
  • poor posture
  • dehydration
  • certain medication
  • flickering screens and flashing lights
  • stuffy atmosphere

Treatment for Migraine

Treatment for migraine means identifying and avoiding the triggers, and then treatment itself in the form of pain killers (such as paracetamol and aspirin) and anti-inflammatory tablets (like ibuprofen and diclofenac).

The key to successful treatment is taking the medicine as soon as the symptoms start – taking it when the pain is severe will have little effect on the migraine. Anti-sickness drugs are often given if you experience nausea and vomiting with your migraine.

One of the most overlooked of all treatments is drinking water. Migraines are made worse by dehydration and consuming copious amounts of water can delay or prevent the onset of a migraine.

Migraines which do not respond to conventional treatments need to be investigated further by a specialist.

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