MEDICAL: PHARMACY PHARMACEUTICAL PHARMACOLOGY RESEARCH:
ClinicalTrials.gov


ClinicalTrials.gov
U.S. National Library of Medicine
U.S. National Institutes of Health
U.S. Department of Health and Human Services
<http://clinicaltrials.gov/>


ClinicalTrials.gov offers up-to-date information for locating federally
and privately supported clinical trials for a wide range of diseases and
conditions. A clinical trial (also clinical research) is a research study
in human volunteers to answer specific health questions. Interventional
trials determine whether experimental treatments or new ways of using
known therapies are safe and effective under controlled environments.
Observational trials address health issues in large groups of people or
populations in natural settings.

ClinicalTrials.gov currently contains 52,006 trials sponsored by the
National Institutes of Health, other federal agencies, and private
industry. Studies listed in the database are conducted in all 50 States
and in 153 countries ClinicalTrials.gov receives over 20 million page
views per month 34,000 visitors daily.

The U.S. National Institutes of Health (NIH), through its National Library
of Medicine (NLM), has developed this site in collaboration with the Food
and Drug Administration (FDA), as a result of the FDA Modernization Act,
which was passed into law in November 1997. See the FDA document -
Guidance for Industry: Information Program on Clinical Trials for Serious
or Life-Threatening Diseases and Conditions (March 2002).

<http://clinicaltrials.gov/ct2/info/about>



Search for Clinical Trials

Find trials for a specific medical condition or other criteria in the
ClinicalTrials.gov registry. ClinicalTrials.gov currently has 52,006
trials with locations in 153 countries.


Investigator Instructions

Get instructions for clinical trial investigators/sponsors about how to
register trials in ClinicalTrials.gov.


Background Information

Learn about clinical trials and how to use ClinicalTrials.gov, or access
other consumer health information from the US National Institutes of
Health.


Resources:

Understanding Clinical Trials

What's New

Glossary



Study Topics:

List by Condition

List by Drug Intervention

List by Sponsor

List by Location



Glossary of Clinical Trials Terms
<http://clinicaltrials.gov/ct2/info/glossary>

Content Sample


The following glossary was prepared to help the consumer become familiar
with many of the common terms used in clinical trials.

ADVERSE REACTION: (Adverse Event.) An unwanted effect caused by the
administration of drugs. Onset may be sudden or develop over time (See
Side Effects).

ADVOCACY AND SUPPORT GROUPS: Organizations and groups that actively
support participants and their families with valuable resources, including
self-empowerment and survival tools.

APPROVED DRUGS: In the U.S., the Food and Drug Administration (FDA) must
approve a substance as a drug before it can be marketed. The approval
process involves several steps including pre-clinical laboratory and
animal studies, clinical trials for safety and efficacy, filing of a New
Drug Application by the manufacturer of the drug, FDA review of the
application, and FDA approval/rejection of application (See Food and Drug
Administration).

ARM: Any of the treatment groups in a randomized trial. Most randomized
trials have two "arms," but some have three "arms," or even more (See
Randomized Trial).

BASELINE: 1. Information gathered at the beginning of a study from which
variations found in the study are measured. 2. A known value or quantity
with which an unknown is compared when measured or assessed. 3. The
initial time point in a clinical trial, just before a participant starts
to receive the experimental treatment which is being tested. At this
reference point, measurable values such as CD4 count are recorded. Safety
and efficacy of a drug are often determined by monitoring changes from the
baseline values.

BIAS: When a point of view prevents impartial judgment on issues relating
to the subject of that point of view. In clinical studies, bias is
controlled by blinding and randomization (See Blind and Randomization).

BLIND: A randomized trial is "Blind" if the participant is not told which
arm of the trial he is on. A clinical trial is "Blind" if participants are
unaware on whether they are in the experimental or control arm of the
study; also called masked. (See Single Blind Study and Double Blind
Study).

CLINICAL: Pertaining to or founded on observation and treatment of
participants, as distinguished from theoretical or basic science.

CLINICAL ENDPOINT: See Endpoint.

CLINICAL INVESTIGATOR: A medical researcher in charge of carrying out a
clinical trial's protocol.

CLINICAL TRIAL: A clinical trial is a research study to answer specific
questions about vaccines or new therapies or new ways of using known
treatments. Clinical trials (also called medical research and research
studies) are used to determine whether new drugs or treatments are both
safe and effective. Carefully conducted clinical trials are the fastest
and safest way to find treatments that work in people. Trials are in four
phases: Phase I tests a new drug or treatment in a small group; Phase II
expands the study to a larger group of people; Phase III expands the study
to an even larger group of people; and Phase IV takes place after the drug
or treatment has been licensed and marketed. (See Phase I, II, III, and IV
Trials).

COHORT: In epidemiology, a group of individuals with some characteristics
in common.

COMMUNITY-BASED CLINICAL TRIAL (CBCT): A clinical trial conducted
primarily through primary-care physicians rather than academic research
facilities.

COMPASSIONATE USE: A method of providing experimental therapeutics prior
to final FDA approval for use in humans. This procedure is used with very
sick individuals who have no other treatment options. Often, case-by-case
approval must be obtained from the FDA for "compassionate use" of a drug
or therapy.

COMPLEMENTARY AND ALTERNATIVE THERAPY: Broad range of healing
philosophies, approaches, and therapies that Western (conventional)
medicine does not commonly use to promote well-being or treat health
conditions. Examples include acupuncture, herbs, etc. Internet Address:
http://www.nccam.nih.gov.

COMPLETED: See Recruitment Status

CONFIDENTIALITY REGARDING TRIAL PARTICIPANTS: Refers to maintaining the
confidentiality of trial participants including their personal identity
and all personal medical information. The trial participants' consent to
the use of records for data verification purposes should be obtained prior
to the trial and assurance must be given that confidentiality will be
maintained.

CONTRAINDICATION: A specific circumstance when the use of certain
treatments could be harmful.

CONTROL: A control is the nature of the intervention control.

CONTROL GROUP: The standard by which experimental observations are
evaluated. In many clinical trials, one group of patients will be given an
experimental drug or treatment, while the control group is given either a
standard treatment for the illness or a placebo (See Placebo and Standard
Treatment).

CONTROLLED TRIALS: Control is a standard against which experimental
observations may be evaluated. In clinical trials, one group of
participants is given an experimental drug, while another group (i.e., the
control group) is given either a standard treatment for the disease or a
placebo.



Categorize All Studies in ClinicalTrials.gov
Main Category: Conditions By Category
<http://clinicaltrials.gov/ct2/search/browse?brwse=cond_cat>


Select a Condition Category


Bacterial and Fungal Diseases
Behaviors and Mental Disorders
Blood and Lymph Conditions
Cancers and Other Neoplasms
Conditions of the Urinary Tract and Sexual Organs, and Pregnancy
Digestive System Diseases
Diseases and Abnormalities at or before Birth
Ear, Nose, and Throat Diseases
Eye Diseases
Gland and Hormone Related Diseases
Heart and Blood Diseases
Immune System Diseases
Injuries, Poisonings, and Occupational Conditions
Mouth and Tooth Diseases
Muscle, Bone, and Cartilage Diseases
Nervous System Diseases
Nutritional and Metabolic Diseases
Parasitic Diseases
Rare Diseases
Respiratory Tract (Lung and Bronchial) Diseases
Skin and Connective Tissue Diseases
Symptoms and General Pathology
Viral Diseases



Content Sample

Condition Category: Behaviors and Mental Disorders
<http://clinicaltrials.gov/ct2/search/browse?brwse=cond_cat_BXM>


Search for Condition


Adjustment Disorders 5 studies
Affective Disorders, Psychotic 389 studies
Affective Symptoms 2 studies
Aggression 164 studies
Agoraphobia 9 studies
AIDS Dementia Complex 18 studies
Alcohol Drinking 85 studies
Alcohol Withdrawal Delirium 1 study
Alcohol-Related Disorders 260 studies
Alcoholic Intoxication 8 studies
Alcoholism 234 studies
Alzheimer Disease 390 studies
Amnesia 35 studies
Amphetamine-Related Disorders 20 studies
Anorexia Nervosa 36 studies
Antisocial Personality Disorder 5 studies
Anxiety Disorders 540 studies
Anxiety, Separation 9 studies
Aphasia, Primary Progressive 21 studies
Asperger Syndrome 15 studies
Attention Deficit and Disruptive Behavior Disorders 260 studies
Attention Deficit Disorder with Hyperactivity 242 studies
Auditory Perceptual Disorders 4 studies
Autistic Disorder 105 studies
Behavior, Addictive 104 studies
Bipolar Disorder 408 studies
Borderline Personality Disorder 30 studies
Bulimia Nervosa 39 studies
Cataplexy 9 studies
Catatonia 2 studies
Child Behavior Disorders 3 studies
Child Development Disorders, Pervasive 108 studies
Cocaine-Related Disorders 210 studies
Cognition Disorders 585 studies
Combat Disorders 6 studies
Communication Disorders 73 studies
Compulsive Behavior 21 studies
Conduct Disorder 19 studies
Conversion Disorder 4 studies
Creutzfeldt-Jakob Syndrome 2 studies
Delirium 583 studies
Delirium, Dementia, Amnestic, Cognitive Disorders 577 studies
Delusions 12 studies
Dementia 604 studies
Dementia, Vascular 23 studies
Depersonalization 2 studies
Depression 1205 studies
Depression, Postpartum 32 studies
Depressive Disorder 1194 studies
Depressive Disorder, Major 499 studies
Developmental Disabilities 125 studies
Disorders of Excessive Somnolence 20 studies
Dissociative Disorders 1 study
Dyslexia 11 studies
Dyslexia, Acquired 1 study
Dyspareunia 9 studies
Dyssomnias 462 studies
Dysthymic Disorder 27 studies
Eating Disorders 90 studies
Encopresis 1 study
Enuresis 9 studies
Erectile Dysfunction 88 studies
Feeding and Eating Disorders of Childhood 1 study
Firesetting Behavior 1 study
Food Habits 3 studies
Gambling 27 studies
Heroin Dependence 46 studies
Huntington Disease 27 studies
Hypochondriasis 3 studies
Hysteria 4 studies
Impulse Control Disorders 38 studies
Jet Lag Syndrome 3 studies
Learning Disorders 14 studies
Lewy Body Disease 8 studies
Marijuana Abuse 49 studies
Marijuana Smoking 8 studies
Mental Disorders Diagnosed in Childhood 454 studies
Mental Fatigue 2 studies
Mental Retardation 89 studies
Mood Disorders 1293 studies
Morphine Dependence 2 studies
Mutism 3 studies
Narcolepsy 18 studies
Neonatal Abstinence Syndrome 7 studies
Neurocirculatory Asthenia 13 studies
Neurotic Disorders 6 studies
Nocturnal Enuresis 4 studies
Obsessive Behavior 1 study
Obsessive-Compulsive Disorder 78 studies
Opioid-Related Disorders 199 studies
Panic Disorder 61 studies
Paranoid Disorders 4 studies
Paraphilias 3 studies
Passive-Aggressive Personality Disorder 1 study
Pedophilia 2 studies
Personality Disorders 54 studies
Phobic Disorders 65 studies
Pick Disease of the Brain 21 studies
Psychoses, Substance-Induced 2 studies
Psychotic Disorders 1136 studies
Quality of Life 780 studies
Reactive Attachment Disorder 1 study
Restless Legs Syndrome 56 studies
Rett Syndrome 9 studies
Schizophrenia 798 studies
Schizophrenia and Disorders with Psychotic Features 785 studies
Schizophrenia, Catatonic 1 study
Schizophrenia, Childhood 2 studies
Schizophrenia, Disorganized 1 study
Schizophrenia, Paranoid 8 studies
Schizotypal Personality Disorder 7 studies
Seasonal Affective Disorder 12 studies
Self Mutilation 1 study
Self-Injurious Behavior 33 studies
Sexual Dysfunctions, Psychological 121 studies
Shared Paranoid Disorder 1 study
Sleep Deprivation 22 studies
Sleep Disorders 502 studies
Sleep Disorders, Circadian Rhythm 16 studies
Sleep Disorders, Intrinsic 397 studies
Sleep Initiation and Maintenance Disorders 142 studies
Smoking 398 studies
Somatoform Disorders 34 studies
Stress Disorders, Post-Traumatic 211 studies
Stress Disorders, Traumatic 214 studies
Stress Disorders, Traumatic, Acute 5 studies
Stress, Psychological 64 studies
Substance Abuse, Intravenous 8 studies
Substance Withdrawal Syndrome 17 studies
Substance-Related Disorders 989 studies
Suicide 40 studies
Suicide, Assisted 1 study
Suicide, Attempted 11 studies
Tic Disorders 46 studies
Tobacco Use Disorder 154 studies
Tourette Syndrome 42 studies
Transsexualism 3 studies
Trichotillomania 7 studies
Vaginismus 1 study




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David Dillard
Temple University
(215) 204 - 4584
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